Adam Rosendorff — Direct
2,135 linesSAN JOSE, CALIFORNIA SEPTEMBER 24, 2021 P R O C E E D I N G S
(COURT CONVENED AT 8:32 A.M.)
(JURY OUT AT 8:32 A.M.)
JUDGE DAVILA: WE ARE ON THE RECORD IN THE HOLMES MATTER. ALL COUNSEL ARE PRESENT. MS. HOLMES IS PRESENT. WE ARE OUTSIDE OF THE PRESENCE OF THE JURY TO TALK ABOUT -- LET'S SEE, MS. KRATZMANN RECEIVED AN EMAIL FROM MR. BOSTIC REGARDING A WITNESS. MR. BOSTIC?
MR. BOSTIC: THANK YOU, YOUR HONOR. GOOD MORNING. JOHN BOSTIC FOR THE UNITED STATES.
JUDGE DAVILA: GOOD MORNING.
MR. BOSTIC: WE WANTED TO BRING AN ISSUE TO THE COURT'S ATTENTION. WE ARE NOT SURE WHETHER THE COURT WILL WANT TO RESOLVE IT NOW OR DURING DR. ROSENDORFF'S CROSS, BUT WE WANTED TO FLAG IT FOR THE COURT. SUBSEQUENT TO DR. ROSENDORFF'S EMPLOYMENT AT THERANOS HE HAS OBTAINED UNRELATED EMPLOYMENT AT A DIFFERENT LAB. IN THE PAST SEVERAL MONTHS THAT LAB WAS THE SUBJECT OF A CMS INSPECTION, AND THAT CMS INSPECTION LED TO SOME FINDINGS OF DEFICIENCIES AT THAT LAB. WE LEARNED ABOUT IT AND PRODUCED THE RECORDS IN OUR POSSESSION RELATING TO THAT MATTER TO THE DEFENSE SEVERAL WEEKS AGO. I REACHED OUT TO DEFENSE TO ASK WHETHER THEY INTENDED TO GO INTO THAT TOPIC ON CROSS, AND I WAS INFORMED THAT THEY MAY. WE BELIEVE THAT'S INAPPROPRIATE CROSS IN THIS CASE. WE BELIEVE THAT IT'S BEYOND THE SCOPE OF DIRECT, AND WE FAIL TO SEE HOW IT FITS INTO THE RULES OF EVIDENCE THAT DELINEATE THE APPROPRIATE AREAS FOR A POSSIBLE WITNESS LIKE THIS.
JUDGE DAVILA: OKAY. THANK YOU. MR. WADE?
MR. WADE: GOOD MORNING, YOUR HONOR. LANCE WADE FOR MS. HOLMES. MR. BOSTIC DID MAKE THAT INQUIRY LAST NIGHT, AND WE WERE AS CANDID AS WE COULD BE WITH HIM, WHICH IS TO SAY WE SAID WE MIGHT USE IT. WE, OF COURSE, DON'T KNOW EXACTLY WHAT WE'RE GOING TO DO BECAUSE WE HAVE NOT HEARD THE DIRECT EXAMINATION. I WOULD HAVE EXPECTED, YOU KNOW, JUST BASED UPON THE DEVELOPMENTS IN THE CASE AND THE DISCLOSURES OF THE GOVERNMENT, THAT DR. ROSENDORFF WOULD TESTIFY ON DIRECT FOR, YOU KNOW, A DAY OR TWO. I UNDERSTAND THAT HE NOW MAY TESTIFY ONLY FOR A COUPLE OF HOURS. IF THAT'S THE CASE, MAYBE WE DON'T NEED IT. I CAN CERTAINLY REPRESENT TO THE COURT WE WOULD NOT NEED TO USE THESE MATERIALS TODAY, SO WE COULD WAIT AND SEE WHAT THE DIRECT EXAMINATION IS AND THEN DEAL WITH IT DOWN THE ROAD, IF NECESSARY. OF COURSE, THE COURT WELL KNOWS UNDER THE ABEL DECISION THAT BIAS IS AN APPROPRIATE BASIS FOR CROSS-EXAMINATION AND AN APPROPRIATE USE OF EXTRINSIC EVIDENCE. SO WHETHER THAT COMES FROM THE PLAINTIFF IN THIS CASE OR NOT, I DON'T KNOW, WE'LL HAVE TO SEE WHAT DR. ROSENDORFF SAYS ON THE STAND.
JUDGE DAVILA: WELL, CERTAINLY BIAS IS ALWAYS RELEVANT IN ANY CASE. BUT THE QUESTION AS I LOOK AT IT IS, HOW FAR AND HOW MUCH, IF ANY, EXAMINATION IS PROPER? AS YOU KNOW, WE HAD A WITNESS EARLIER AND THE WITNESS'S POST EVENT EMPLOYMENT WAS DISCUSSED, AND THE COURT FOUND THAT'S NOT RELEVANT. IT MIGHT BE RELEVANT IN THIS CASE, BUT I DON'T KNOW. WITH THIS WITNESS, I DON'T KNOW. I THINK I GRANTED YOUR MOTION TO NOT ALLOW THAT TESTIMONY TO COME IN BECAUSE POST EMPLOYMENT FROM THERANOS AS TO THAT WITNESS WAS -- YOU REMEMBER THAT WITNESS.
MR. WADE: I NOW DO REMEMBER. I WAS SEARCHING MY MEMORY BANK, AND I BELIEVE IT WAS A COUPLE WEEKS AGO, BUT IT FEELS SLIGHTLY LONGER THAN THAT AS THIS POINT. BUT I DO RECALL THAT ISSUE AND, AS A RESULT OF THE NATURE OF THAT EXAMINATION, THAT WAS -- I DON'T BELIEVE THE GOVERNMENT WAS SAYING THAT THEY WERE OFFERING IT FOR BIAS, AND WE CERTAINLY, I THINK, AT THE TIME EXPLICITLY SAID WE WERE NOT GOING INTO BIAS ON THAT WITNESS. SO WHAT HAPPENS HERE I DON'T KNOW. THERE ARE A COUPLE OF INSTANCES OF EMPLOYMENT, POST THERANOS EMPLOYMENT BY -- THAT THE GOVERNMENT IS AWARE OF. I THINK IT'S FAIR TO ASSUME THAT WE GIVE THEM NOTICE THAT WE MAY USE THAT. WE MAY SEEK TO USE THAT. IF WE -- IF THE COURT WANTS US TO ADDRESS THAT AGAIN, MAYBE TUESDAY MORNING OR MONDAY AFTERNOON, ONCE WE HAVE A BETTER SENSE, WE'RE HAPPY TO DO THAT AND I WILL MAKE THE COMMITMENT TO THE COURT THAT WE WILL NOT GO INTO THOSE MATTERS TODAY.
JUDGE DAVILA: OKAY. WELL, THANK YOU. DO YOU ANTICIPATE YOUR TIME ON DIRECT WITH THIS WITNESS TO TAKE UP THE MORNING?
MR. BOSTIC: I THINK IT WILL TAKE UP THE MORNING AND IT WILL GO INTO THE AFTERNOON AND PROBABLY WELL INTO THE AFTERNOON. SO I AGREE WITH MR. WADE ON TIMING. THAT'S ALL WE'RE ASKING FOR IS AN OPPORTUNITY TO ADDRESS THIS WITH THE COURT, AND WE WANTED TO PUT THE DEFENSE ON NOTICE AND RAISE IT WITH THE COURT IN THE INTEREST OF EFFICIENCY SO THERE'S A CHANCE TO TALK ABOUT IT AND TO HEAR THE DEFENSE'S ARTICULATION FOR WHY IT'S ADMISSIBLE CROSS BEFORE IT GETS RAISED DURING THE EXAMINATION OF THE WITNESS.
JUDGE DAVILA: SURE. I APPRECIATE YOUR ATTENTION TO THIS. LET'S SEE WHERE WE GO. THANK YOU FOR YOUR INFORMATION ABOUT HOW LONG YOU THINK YOUR DIRECT WILL BE. IT SOUNDS LIKE IT MAY COME UP THIS AFTERNOON, LATE THIS AFTERNOON, MAYBE NOT. BUT IF IT DOES, IF YOU FINISH WITH YOUR DIRECT, MY SENSE IS THAT WITH THE TIME REMAINING, MR. WADE, YOU CAN -- YOU HAVE OTHER AREAS TO PROBE BEFORE YOU GET INTO THIS I WOULD THINK.
MR. WADE: I DO, YOUR HONOR. SO I DON'T SEE A NEED TO ADDRESS IT AND TAKE UP ANY TIME WITH THE JURY CERTAINLY. ONCE WE HAVE A BETTER SENSE OF THE SCOPE OF THE DIRECT, WE CAN CONFER AND ADVISE THE COURT WHETHER WE NEED TO COME BACK TO THE COURT.
JUDGE DAVILA: OKAY. OKAY.
MR. WADE: SINCE WE'RE HERE, YOUR HONOR, I DO HAVE TWO OTHER SMALL ITEMS THAT I JUST WOULD RAISE WITH RESPECT TO DR. ROSENDORFF.
JUDGE DAVILA: SURE. LET ME -- BEFORE YOU DO THAT, PARDON ME. IF WE WANT TO DISCUSS THIS ISSUE BEFORE TUESDAY'S TESTIMONY, I THINK OUR MONDAY MORNING CALENDAR -- DO WE HAVE ANYTHING ON CALENDAR MONDAY, MS. KRATZMANN?
COURT CLERK: WE DO NOT, YOUR HONOR.
JUDGE DAVILA: WE HAVE AN AFTERNOON CRIMINAL CALENDAR, WHICH IS A STANDING CALENDAR, BUT MY MONDAY MORNING IS AVAILABLE, SO WE COULD MEET TO DISCUSS THIS ISSUE MONDAY MORNING, AGAIN, MR. WADE, AT 5:00 A.M. IF THAT'S YOUR PREFERENCE.
MR. WADE: MY UNDERSTANDING IS THAT'S WHAT THE COURT REPORTER PREFERS, YOUR HONOR, SO I'LL BE HAPPY TO ACCOMMODATE.
JUDGE DAVILA: OKAY. SO LET'S MOVE TO YOUR OTHER ISSUES.
MR. WADE: THE OTHER ISSUE, JUST SMALL ISSUES THAT I WANTED TO RAISE, I'M SURE THE GOVERNMENT IS PROBABLY NOT INTENDING TO BRING CERTAIN ITEMS OF SPECULATION OUT ON DIRECT, BUT I JUST WANT TO FLAG THEM IN ADVANCE TO GET CLARITY OF THAT. ONE IS THAT THERE ARE SOME STATEMENTS IN SOME RECENT DISCLOSURES FROM THE GOVERNMENT THAT DR. ROSENDORFF HEARD THAT MS. HOLMES WAS BCC'D ON ALL EMAILS TO MR. BALWANI. WE BELIEVE THAT'S NOT THE CASE, NOR DOES THIS WITNESS HAVE FOUNDATION TO OFFER THAT, SO I JUST WANT TO -- I DON'T WANT TO CREATE ANY MISIMPRESSION WITH THE JURY, SO I JUST WANTED TO RAISE THAT ISSUE.
JUDGE DAVILA: OKAY.
MR. BOSTIC: I DON'T INTEND TO ELICIT THAT TESTIMONY, YOUR HONOR.
MR. WADE: AND THEN ONE OTHER SMALL POINT OF A SIMILAR NATURE. THERE'S AN INSTANCE WHERE DR. ROSENDORFF OFFERS SPECULATION AS TO WHY CERTAIN INFORMATION WAS NOT TO BE -- MR. BALWANI ASKED NOT TO BE INCLUDED ON CERTAIN REPORTS. WE WOULD JUST, AGAIN, SUGGEST THAT THERE'S, THERE'S NOT A BASIS FOR THIS WITNESS TO SPECULATE AS TO DOCTOR -- AS TO MR. BALWANI'S REASONS FOR NOT WANTING TO DO SOMETHING. HE CAN OBVIOUSLY TESTIFY AS TO THE FACTS AND, TO A DEGREE, HIS INTERACTIONS WITH MR. BALWANI. BUT WE WANT TO MAKE SURE THAT THE SPECULATION ABOUT MR. BALWANI'S REASONS IS NOT OFFERED IN COURT.
MR. BOSTIC: YOUR HONOR, ON THAT, I DON'T INTEND TO ELICIT ANY SPECULATION FROM THIS WITNESS. I CONFESS, THOUGH, I'M NOT SURE WHAT INSTANT DEFENSE COUNSEL IS REFERRING TO WHEN HE TALKS ABOUT CERTAIN INFORMATION IN CERTAIN REPORTS.
MR. WADE: THERE WAS AN INSTANCE THAT WAS DISCLOSED IN A 302 THAT A REAGENT WAS USED OR CERTAIN ITEMS WERE NOT DISCLOSED TO A PATIENT. DR. ROSENDORFF SPECULATED THAT THE REASON THAT MR. BALWANI DIDN'T WANT TO DO THAT WAS SOME NEFARIOUS REASON. AGAIN, I WOULD ASSUME THE GOVERNMENT WOULDN'T SEEK TO OFFER SUCH EVIDENCE. I JUST WANT TO MAKE CLEAR THAT THAT'S THE CASE.
MR. BOSTIC: SO, YOUR HONOR, I, I DON'T INTEND TO ASK THIS WITNESS TO ACT AS A MIND READER. I KNOW HE DOESN'T KNOW WHAT WAS INSIDE MR. BALWANI'S HEAD. I THINK HE IS QUALIFIED TO GIVE HIS IMPRESSION ABOUT WHAT MR. BALWANI APPEARED TO PRIORITIZE AT VARIOUS TIMES. HE WORKED CLOSELY WITH MR. BALWANI FOR A NUMBER OF MONTHS AND HAS A GOOD FOUNDATION TO TESTIFY ON THAT BASIS. SO I THINK IF THAT'S THE TESTIMONY THAT MR. WADE IS REFERRING TO, I THINK IT IS ADMISSIBLE, BUT IT WON'T BE SPECULATION.
JUDGE DAVILA: ALL RIGHT. GREAT. THANK YOU.
MR. BOSTIC: YOUR HONOR, I APOLOGIZE, ONE RELATED ISSUE FOR DR. ROSENDORFF THAT I FAILED TO MENTION. ANOTHER ITEM RELATING TO HIS POST-THERANOS EMPLOYMENT, HE ALSO WORKED FOR A COMPANY, AND I BELIEVE THE COURT IS AWARE OF THIS, THAT LATER BECAME THE SUBJECT OF AN UNRELATED GOVERNMENT INVESTIGATION. THE GOVERNMENT HAS PRODUCED A LARGE VOLUME OF DOCUMENTS TO THE DEFENSE ON THAT TOPIC. THOSE DOCUMENTS ARE SUBJECT TO A PROTECTIVE ORDER THAT REQUIRES THE DEFENSE TO PROVIDE THE GOVERNMENT WITH NOTICE IF IT INTENDS TO GET INTO THAT TOPIC, THOSE DOCUMENTS OR THE FACTS THEREIN IN COURT. WE HAVE NOT RECEIVED THAT NOTICE FROM THE DEFENSE, SO WE ASSUME THAT THE DEFENSE IS NOT PLANNING TO GET INTO THAT TOPIC WITH DR. ROSENDORFF, BUT I WANTED TO FLAG IT FOR THE DEFENSE AND THE COURT AS WELL.
MR. WADE: I THINK -- IT'S A VERY RELATED ISSUE TO THE OTHER ITEM WITH THE OTHER LAB, YOUR HONOR. I THINK FOR PURPOSES OF DISCLOSURE AND CONSIDERATION BY THE GOVERNMENT, THEY SHOULD ASSUME THAT WE WILL GO INTO THAT, OR MAY INTEND TO GO INTO THAT I WOULD SAY. SO WE WOULD PROVIDE NOTICE HERE THAT WE MAY DO THAT. I DON'T HAVE PARTICULAR DOCUMENTS THAT I WAS INTENDING TO OFFER, BUT, AGAIN, DEPENDING ON WHAT THE WITNESS SAYS AND IN THE INTEREST OF TRYING TO BE CAUTIOUS IN TERMS OF SUCH DISCLOSURES, THE GOVERNMENT SHOULD ASSUME THAT WE WILL SEEK TO OFFER THAT EVIDENCE.
JUDGE DAVILA: OKAY. WELL, THANK YOU FOR THAT. IT SOUNDS TO ME LIKE WE MAY NEED MONDAY MORNING TO DISCUSS THIS FURTHER, AND THAT WOULD BE MY PREFERENCE, RATHER THAN WAITING UNTIL TUESDAY MORNING. SO YOU'LL HAVE THE WEEKEND TO LOOK AT THIS AND DEVELOP ANY PLEADINGS THAT YOU HAVE AND GET THOSE TO ME SO WE CAN STUDY THEM AND THEN BE PREPARED TO HAVE A FULSOME CONVERSATION MONDAY MORNING.
MR. WADE: SURE. I THINK THAT WOULD BE APPROPRIATE, YOUR HONOR. I KNOW THE COURT DOESN'T WANT US TO HAVE TO DISCLOSE CROSS-EXAMINATION IN ADVANCE, AND WE OBVIOUSLY DON'T KNOW WHAT THE SCOPE OF IT WILL BE, SO THAT SOUNDS APPROPRIATE.
JUDGE DAVILA: WELL, IT'S PREDICATED ON THE DIRECT, OF COURSE. I KNOW YOU HAVE TO DECIDE THAT.
JUDGE DAVILA: SO MONDAY MORNING MIGHT BE A GOOD TIME. SO WHY DON'T YOU RESERVE MONDAY MORNING. I'LL CHECK WITH OUR COURT REPORTER AS TO TIMING, AND WE'LL LET YOU KNOW ON THAT.
JUDGE DAVILA: ALL RIGHT. THANK YOU. LET ME SEE. BREAKS TODAY? DO YOU HAVE A SUGGESTED BREAK TIME? SHOULD WE BREAK AT 10:45 FOR 30 MINUTES? AND DOES THAT WORK FOR THE PARTIES? I TOLD THE JURY WE MAY GO UNTIL 3:00 TODAY. NOW, IT MAY DEPEND, IF WE RUN INTO THIS ISSUE WITH DR. ROSENDORFF AND WE NEED TO STOP BEFORE 3:00, WE CAN DO THAT. BUT IT SOUNDS LIKE IT MIGHT BE 3:00 BEFORE WE GET INTO SOME THRESHOLD ISSUES.
MR. BOSTIC: I THINK SO.
JUDGE DAVILA: WE'LL BREAK FOR 30 MINUTES ABOUT A QUARTER UNTIL 11:00, AND THEN ABOUT 1:45 FOR 20 OR 30 MINUTES LATER ON, AND THEN WE'LL PRESS ON FOR THE REST OF THE DAY.
JUDGE DAVILA: ALL RIGHT. THANK YOU.
COURT CLERK: COURT IS IN RECESS.
(RECESS FROM 8:45 A.M. UNTIL 9:04 A.M.)
(JURY IN AT 9:04 A.M.)
JUDGE DAVILA: ALL RIGHT. THANK YOU. GOOD MORNING. WE ARE BACK ON THE RECORD IN UNITED STATES VERSUS ELIZABETH HOLMES. ALL COUNSEL ARE PRESENT. MS. HOLMES IS PRESENT. OUR JURY AND ALTERNATES ARE PRESENT. GOOD MORNING, LADIES AND GENTLEMEN. NICE TO SEE YOU AGAIN. LET ME ASK THAT QUESTION THAT I WILL POSE TO YOU EACH DAY AS I'VE INDICATED. I'M CURIOUS AND WOULD LIKE TO KNOW WHETHER ANY OF YOU HAVE, OVER THE COURSE OF OUR BREAK, WHETHER ANY OF YOU HAVE LEARNED ANYTHING ABOUT THIS CASE, SHARED ANY INFORMATION ABOUT THIS CASE OUTSIDE OF THE COURTROOM THROUGH ANY SOCIAL MEDIA, READING, LISTENING, OR DISCUSSING, OR IF ANY OF THAT HAS COME TO PASS, EITHER INTENTIONAL OR ACCIDENTAL. IF ANY OF YOU HAVE HAD ANY OF THAT EXPERIENCE, IF YOU WOULD RAISE YOUR HAND, I WOULD APPRECIATE IT. AGAIN, I'M HAPPY TO SPEAK WITH YOU PRIVATELY IF YOU WISH. I SEE NO HANDS. THANK YOU. BEFORE WE BEGIN -- I THINK THE GOVERNMENT HAS ANOTHER WITNESS. BUT BEFORE WE BEGIN, I JUST WANT TO REMIND EVERYONE IN THE COURTROOM THAT RECORDING OF ANY PROCEEDINGS IN THIS COURTROOM, INCLUDING ANY PHOTOGRAPHING OF ANY PROCEEDINGS IN THIS COURTROOM, IS PROHIBITED AND THAT YOU MAY NOT DO THAT. THAT IS RECORDING VIA ANY DEVICE YOU HAVE, ANY MACHINE, CELL PHONE OR OTHER ITEM IS STRICTLY PROHIBITED. IF THAT'S BROUGHT TO MY ATTENTION, WE'LL HAVE TO TAKE SOME MEASURES ABOUT THAT. SO I JUST WANTED TO ADVISE EVERYONE TO PLEASE DISABLE ANY DEVICE YOU HAVE, IF IT IS CONNECTED TO ANY RECORDING, VIDEO, OR AUDIO RECORDING, I WOULD APPRECIATE IT TO BE IN COMPLIANCE WITH THE RULES OF THIS COURTHOUSE. THANK YOU. DOES THE GOVERNMENT HAVE ANOTHER WITNESS TO CALL?
MR. BOSTIC: YES, YOUR HONOR. THE UNITED STATES CALLS DR. ADAM ROSENDORFF.
JUDGE DAVILA: SIR, IF YOU WOULD COME FORWARD, PLEASE. I'LL INVITE YOU TO STAND OVER HERE WHILE YOU FACE OUR COURTROOM DEPUTY. IF YOU WOULD RAISE YOUR RIGHT HAND, SHE HAS A QUESTION FOR YOU.
COURT CLERK: GOOD MORNING.
(GOVERNMENT'S WITNESS, ADAM ROSENDORFF, WAS SWORN.)
ADAM ROSENDORFF: YES.
JUDGE DAVILA: PLEASE HAVE A SEAT HERE, SIR. LET ME INVITE YOU TO MAKE YOURSELF COMFORTABLE. FEEL FREE TO ADJUST THE CHAIR AND MICROPHONE AS YOU NEED. I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE. MR. BOSTIC WILL HAVE A QUESTION FOR YOU IN JUST A MOMENT IN REGARDS TO YOUR MASK. WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME AND SPELL IT, PLEASE.
ADAM ROSENDORFF: ADAM ROSENDORFF, A-D-A-M, R-O-S-E-N-D-O-R-F-F.
JUDGE DAVILA: THANK YOU. COUNSEL.
DIRECT EXAMINATION BY MR. BOSTIC:
MR. BOSTIC: GOOD MORNING, DR. ROSENDORFF.
ADAM ROSENDORFF: GOOD MORNING.
MR. BOSTIC: I UNDERSTAND FROM THE COURT THAT IF YOU ARE VACCINATED AND YOU ARE COMFORTABLE REMOVING YOUR MASK AND TESTIFYING WITHOUT A MASK, YOU ARE WELCOME TO DO SO.
ADAM ROSENDORFF: THANK YOU.
JUDGE DAVILA: MR. BOSTIC, BEFORE YOU BEGIN, I JUST WANT TO ALERT YOU AND THE JURY THAT WE'LL TAKE OUR BREAK, OUR MORNING BREAK AT 10:45, LADIES AND GENTLEMEN. THAT WILL BE ABOUT 30 MINUTES. THAT'S OUR BREAK TIME. THANK YOU.
MR. BOSTIC: THANK YOU, YOUR HONOR.
JUDGE DAVILA: THANK YOU.
MR. BOSTIC: MAY I APPROACH THE WITNESS, YOUR HONOR?
JUDGE DAVILA: YES.
MR. BOSTIC: (HANDING.)
MR. BOSTIC: DR. ROSENDORFF, WERE YOU AT ONE TIME EMPLOYED BY A COMPANY CALLED THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS YOUR POSITION AT THE COMPANY?
ADAM ROSENDORFF: LAB DIRECTOR.
MR. BOSTIC: AND WHAT WERE THE APPROXIMATE DATES OF YOUR EMPLOYMENT AT THERANOS?
ADAM ROSENDORFF: APRIL 2013 TO NOVEMBER 2014.
MR. BOSTIC: WHAT WAS YOUR REASON FOR LEAVING THE COMPANY?
ADAM ROSENDORFF: THERE WERE MANY FACTORS. ONE WAS THE UNWILLINGNESS OF MANAGEMENT TO PERFORM PROFICIENCY TESTING AS REQUIRED BY LAW. I FELT PRESSURED TO VOUCH FOR TESTS THAT I DID NOT HAVE CONFIDENCE IN. I CAME TO BELIEVE THAT THE COMPANY BELIEVED MORE ABOUT PR AND FUNDRAISING THAN ABOUT PATIENT CARE; AND ALSO THE EQUIPMENT AND REAGENTS, THE PLATFORM WAS NOT ALLOWING ME TO FUNCTION EFFECTIVELY AS A LAB DIRECTOR.
MR. BOSTIC: LET'S GO BACKWARD IN TIME A LITTLE BIT FROM YOUR TIME AT THERANOS. CAN YOU SUMMARIZE YOUR EDUCATION FOR ME, BEGINNING WITH COLLEGE?
ADAM ROSENDORFF: SURE. I GREW UP IN SOUTH AFRICA. I GRADUATED WITH A BACHELOR OF ARTS DEGREE FROM THE UNIVERSITY OF WIWATERSRAND AND THEN CAME TO THE UNITED STATES IN 1993. I ATTENDED MEDICAL SCHOOL AT MOUNT SINAI SCHOOL OF MEDICINE IN NEW YORK CITY FROM 1995 TO 2000. FOLLOWING THAT I DID A FELLOWSHIP IN INFECTIOUS DISEASES, BASIC SCIENCE RESEARCH UNTIL 2005. I THEN DID A RESIDENCY IN CLINICAL PATHOLOGY, OTHERWISE KNOWN AS LABORATORY MEDICINE, FROM 2005 UNTIL 2008. I WAS THEN EMPLOYED AS LAB DIRECTOR AT THE UNIVERSITY OF PITTSBURGH CHILDREN'S HOSPITAL. I LEFT THERE IN 2013 TO JOIN THERANOS.
MR. BOSTIC: YOU MENTIONED THAT YOU DID A RESIDENCY. CAN YOU JUST DESCRIBE AT A HIGH LEVEL WHAT A RESIDENCY IS?
ADAM ROSENDORFF: A RESIDENCY IS FURTHER TRAINING FOLLOWING MEDICAL SCHOOL WHERE A PHYSICIAN SPECIALIZES IN A PARTICULAR MEDICAL FIELD AND RECEIVES SPECIALIZED TRAINING AND CERTIFICATION FOLLOWING THAT.
MR. BOSTIC: AND IN WHAT FIELD DID YOU SPECIALIZE DURING YOUR RESIDENCY?
ADAM ROSENDORFF: CLINICAL PATHOLOGY.
MR. BOSTIC: AND WHAT DOES THAT MEAN IN PLAIN LANGUAGE?
ADAM ROSENDORFF: CLINICAL PATHOLOGY IS ALL OF PATHOLOGY, EXCLUDING TISSUE EXAMINATION OR AUTOPSY. SO IT FOCUSES ON THE DIAGNOSIS OF DISEASE IN THE LABORATORY.
MR. BOSTIC: THE LABORATORY THAT YOU WORKED AT AT THE UNIVERSITY OF PITTSBURGH, WAS IT A LABORATORY THAT PERFORMED BLOOD TESTING ANALYSIS?
ADAM ROSENDORFF: YES, SIR.
MR. BOSTIC: HOW ABOUT BOARD CERTIFICATIONS? DO YOU HAVE ANY BOARD CERTIFICATIONS?
ADAM ROSENDORFF: YES. I'M ACTIVE BOARD CERTIFIED IN CLINICAL PATHOLOGY BY THE AMERICAN BOARD OF PATHOLOGY.
MR. BOSTIC: LET'S TALK A LITTLE BIT ABOUT THE LAB DIRECTOR POSITION. WHAT IS A LAB DIRECTOR?
ADAM ROSENDORFF: A LAB DIRECTOR IS RESPONSIBLE FOR ENSURING THAT THE TESTS THAT COME OUT OF A LAB ARE APPROPRIATE FOR PATIENT CARE, AND THAT ENTAILS A NUMBER OF FACTORS, SUCH AS ENSURING THAT THE EMPLOYEES ARE TRAINED AND COMPETENT, ENROLLMENT IN PROFICIENCY TESTING, AND ENSURING THAT THE LAB HAS A QUALITY MANAGEMENT SYSTEM, DOCUMENTING CORRECTIVE ACTIONS, DEVIATIONS, AND REVIEWING REPORTS IN CONSULTATION WITH CLIENTS AND PHYSICIANS WHEN APPROPRIATE.
MR. BOSTIC: ARE THERE CERTAIN QUALIFICATIONS THAT ONE HAS TO HAVE IN ORDER TO BE A LAB DIRECTOR?
ADAM ROSENDORFF: YES. PER CLIA, THEY ALLOW M.D.'S OR PH.D.'S TO BE LAB DIRECTORS. I BELIEVE THE M.D. REQUIRES A YEAR OF EXPERIENCE IN A HIGH COMPLEXITY CLINICAL LABORATORY, AND THE PH.D. REQUIRES SPECIALTY BOARD CERTIFICATION FROM A CMS RECOGNIZED BOARD.
MR. BOSTIC: AND THROUGH WHICH ONE OF THOSE PATHS WERE YOU QUALIFIED TO BE A LAB DIRECTOR?
ADAM ROSENDORFF: M.D. PATH.
MR. BOSTIC: YOU TALKED A LITTLE BIT ABOUT A LAB DIRECTOR'S RESPONSIBILITIES. DO THEY INCLUDE MONITORING THE ACCURACY OF TESTS BEING CONDUCTED BY THE LAB?
ADAM ROSENDORFF: DEFINITELY.
MR. BOSTIC: WHEN WE TALK ABOUT ACCURACY IN THE CONTEXT OF LAB TESTS, WHAT DOES THAT MEAN?
ADAM ROSENDORFF: ACCURACY IS THE CLOSENESS OF THE RESULT GENERATED BY THE LAB TO THE TRUE RESULT, THE TRUE BIOLOGICAL RESULT IN THE PATIENT.
MR. BOSTIC: AND APOLOGIES FOR AN OBVIOUS QUESTION, BUT WHY IS THAT IMPORTANT IN THE FIELD OF LABORATORY TESTING?
ADAM ROSENDORFF: PHYSICIANS AND OTHER HEALTH CARE PROVIDERS RELY --
JUDGE DAVILA: EXCUSE ME, DOCTOR.
JUDGE DAVILA: ARE YOU SEEKING TO QUALIFY THIS WITNESS AS AN EXPERT?
MR. BOSTIC: NOT AT THIS TIME, YOUR HONOR. I BELIEVE HE HAS A FOUNDATION TO OFFER THIS AS LAY TESTIMONY.
JUDGE DAVILA: I THINK IT'S GENERAL FOUNDATION.
BY MR. BOSTIC:
MR. BOSTIC: WOULD YOU LIKE ME TO REPEAT THE QUESTION, DR. ROSENDORFF?
ADAM ROSENDORFF: YES, PLEASE.
MR. BOSTIC: THE QUESTION IS, WHY IS ACCURACY IMPORTANT, IF IT IS IMPORTANT, IN THE CONTEXT OF LABORATORY TESTING?
ADAM ROSENDORFF: ACCURACY IS CRITICAL. PHYSICIANS AND OTHER HEALTH CARE PROVIDERS DEPEND ON THE ACCURACY OF A TEST TO MAKE MEDICAL DECISIONS, SOMETIMES LIFE AND DEATH MEDICAL DECISIONS.
MR. BOSTIC: ARE YOU FAMILIAR WITH THE CONCEPT OF PRECISION SEPARATE FROM THE CONCEPT OF ACCURACY?
ADAM ROSENDORFF: YES, SIR.
MR. BOSTIC: AND WHAT DOES PRECISION MEAN WHEN IT COMES TO LAB TESTING?
ADAM ROSENDORFF: PRECISION IS ALSO KNOWN AS REPEATABILITY. IT IS THE ABILITY OF A LAB TEST TO RETURN RESULTS FROM THE SAME SAMPLE THAT ARE SUFFICIENTLY CLOSE TOGETHER WITHIN PREDEFINED RANGES THAT ARE ACCEPTABLE FOR PATIENT CARE.
MR. BOSTIC: AND AT THE LABS THAT YOU'VE WORKED AT, HOW IS PRECISION MEASURED AND QUANTIFIED?
ADAM ROSENDORFF: PRECISION IS A REQUIRED ELEMENT OF THE VALIDATION REPORT. AT MINIMUM IT REQUIRES MEASURING BOTH INTRADAY PRECISION AND INTERDAY PRECISION. INTRADAY PRECISION IS WITH THE SAME OPERATOR AND SAME EQUIPMENT, AND AT MINIMUM YOU HAVE TO REPEAT A TEST 20 TIMES ON THE SAME SAMPLE. AND THEN INTERDAY INVOLVES MULTIPLE OPERATORS AND MULTIPLE INSTRUMENTS OVER MANY DAYS, TYPICALLY FIVE, WITH TYPICALLY MORE THAN 20 OBSERVATIONS AND MEASUREMENTS.
MR. BOSTIC: AND BASED ON YOUR WORK IN DOING THAT KIND OF ASSESSMENT, WHAT IS THE OUTPUT OF THAT KIND OF TESTING? WHAT DO YOU END UP WITH BY WAY OF RESULT?
ADAM ROSENDORFF: YOU END UP WITH A METRIC THAT IS KNOWN AS THE COEFFICIENT OF VARIATION AND IT'S A PERCENTAGE, AND THE LOWER THE COEFFICIENT OF VARIATION, THE MORE PRECISE THE TEST IS.
MR. BOSTIC: AS A LABORATORY DIRECTOR, IS IT ALSO PART OF YOUR RESPONSIBILITY TO COMMUNICATE WITH DOCTORS AND PATIENTS ABOUT YOUR RESULTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: HOW ABOUT THE ROLE OF RESEARCHING AND DEVELOPING ASSAYS? IS THAT PART OF A LAB DIRECTOR'S JOB?
ADAM ROSENDORFF: THE LAB DIRECTOR WORKS WITH RESEARCH AND DEVELOPMENT TO MAKE SURE ALL OF THE REQUIRED ELEMENTS OF THE VALIDATION ARE EXECUTED ACCORDING TO REGULATIONS, AND ALSO THAT THE VALIDATION IS TAILORED TOWARDS PRACTICAL UTILITY AND PATIENT CARE.
MR. BOSTIC: LET'S TALK ABOUT YOUR INITIAL CONTACT WITH THERANOS. HOW DID YOU FIRST LEARN ABOUT THE COMPANY?
ADAM ROSENDORFF: I WAS WORKING IN PITTSBURGH AS THE LAB DIRECTOR THERE, AND I WENT ONTO LINKEDIN AND I SAW THAT THERANOS WAS ADVERTISING FOR A LAB DIRECTOR AND I APPLIED FOR THE JOB AND I WAS CONTACTED BY A RECRUITER.
MR. BOSTIC: AND DID YOU THEN INTERVIEW FOR THE POSITION?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT DO YOU RECALL ABOUT THAT PROCESS GENERALLY?
ADAM ROSENDORFF: I FLEW OUT TO SAN FRANCISCO. THE INTERVIEW WAS AROUND 6:00 P.M. I MET WITH SUNNY BALWANI, ELIZABETH HOLMES, DANIEL YOUNG. I MET IN A SMALL ROOM THAT WAS LOCKED OFF OR SEPARATED FROM THE LABORATORY. IS THERE SOMETHING SPECIFIC ABOUT THE INTERVIEW YOU WANTED TO ASK?
MR. BOSTIC: I'LL ASK A FOLLOW-UP QUESTION.
ADAM ROSENDORFF: YEAH.
MR. BOSTIC: DID YOU MEET WITH ALL THREE INDIVIDUALS AT ONCE OR INDIVIDUALLY?
ADAM ROSENDORFF: INDIVIDUALLY.
MR. BOSTIC: AND WERE YOU SUBSEQUENTLY OFFERED A JOB AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID YOU ACCEPT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WHY DID YOU ACCEPT THE JOB AT THERANOS? WHY DID YOU MAKE THAT DECISION?
ADAM ROSENDORFF: I REALLY BOUGHT INTO THE IDEA OF LABORATORY TESTING BEING DONE FROM A VERY SMALL PINPRICK SAMPLE AND THOUGHT THAT WOULD BE ADVANTAGEOUS TO PATIENTS. I BELIEVED THAT THERANOS HAD ADVANCED TECHNOLOGY THAT WOULD ALLOW THEM TO DO THIS. I WAS IMPRESSED BY THE EARNESTNESS AND THE DEDICATION THAT I SENSED IN THE INTERVIEWERS, AND I THOUGHT IT WAS GOING TO BE THE NEXT APPLE.
MR. BOSTIC: AND THE INFORMATION THAT CAUSED YOU TO FEEL THAT WAY, WHERE DID IT COME FROM?
ADAM ROSENDORFF: I HAD READ THROUGH SOME OF THE PATENT APPLICATIONS THAT THE COMPANY HAD BEEN APPROVED FOR ON THE INTERNET. I HONESTLY DID NOT KNOW VERY MUCH AT THAT TIME ABOUT WHAT KIND OF TECHNOLOGY THE COMPANY WAS DEVELOPING OR RUNNING.
MR. BOSTIC: I'D LIKE TO TALK A LITTLE BIT ABOUT HOW YOU FIT INTO THE STRUCTURE OF THE COMPANY. FIRST OF ALL, WHEN YOU WERE A LAB DIRECTOR AT THERANOS, WERE THERE ANY OTHER LAB DIRECTORS?
ADAM ROSENDORFF: I DIDN'T BECOME THE LAB DIRECTOR OF RECORD UNTIL THE MIDDLE OF 2013 BECAUSE I WAS APPLYING FOR MY CALIFORNIA MEDICAL LICENSE. AND THEN IN EARLY 2014 THE COMPANY HIRED THE CO-LAB DIRECTOR, MARK PANDORI, WHO ASSISTED ME IN SOME OF THE LAB DIRECTOR FUNCTIONS.
MR. BOSTIC: BEFORE YOU BECAME LAB DIRECTOR, WAS SOMEONE ELSE HOLDING THAT TITLE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO WAS THAT?
ADAM ROSENDORFF: ARNOLD GELB.
MR. BOSTIC: AND AS LAB DIRECTOR, WHAT POSITIONS IN THE COMPANY REPORTED TO YOU?
ADAM ROSENDORFF: IT WAS, IT WAS NOT MADE CLEAR TO ME WHO MY DIRECT REPORTS WOULD BE WITHIN THE COMPANY.
MR. BOSTIC: OVER TIME, DID YOU COME TO HAVE AN UNDERSTANDING OF WHO WORKED UNDERNEATH YOU AT THE LAB?
ADAM ROSENDORFF: I HAD REGULAR MEETINGS WITH THE CLIA GROUP, CLINICAL LABORATORY SCIENTISTS, AND THE QUALITY DIRECTOR. MY UNDERSTANDING WAS THAT THOSE WERE THE FOLKS THAT WERE REPORTING TO ME OR ACCOUNTABLE TO ME.
MR. BOSTIC: AND THE CLINICAL LABORATORY SCIENTISTS, WHAT WAS THEIR DAILY WORK AT THE COMPANY, GENERALLY SPEAKING?
ADAM ROSENDORFF: THEY WERE THE ONES WHO WENT THROUGH A TRAINING PROGRAM AND CERTIFICATION AND, PER CALIFORNIA BUSINESS AND PROFESSIONS CODE, THEY'RE THE ONES WHO ARE ACTUALLY ALLOWED TO HANDLE PATIENT SPECIMENS AND TO REPORT OUT RESULTS IN THE LABORATORY INFORMATION SYSTEM.
MR. BOSTIC: AND WAS THERE SOMEONE AT THE COMPANY THAT YOU REPORTED TO?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO DID YOU REPORT TO?
ADAM ROSENDORFF: SUNNY BALWANI.
MR. BOSTIC: AND WHO WAS ABOVE MR. BALWANI AT THE COMPANY, IF ANYONE?
ADAM ROSENDORFF: ELIZABETH HOLMES.
MR. BOSTIC: DID THERE COME A TIME WHEN THERANOS BEGAN OFFERING ITS BLOOD TEST SERVICES TO THE PUBLIC?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU RECALL APPROXIMATELY WHEN THAT WAS?
ADAM ROSENDORFF: IT WAS EARLY IN SEPTEMBER OF 2013. I THINK THE 9TH OF SEPTEMBER.
MR. BOSTIC: AND DID THERANOS CONTINUE OFFERING BLOOD TESTING SERVICES TO THE PUBLIC THROUGHOUT THE REST OF YOUR TIME AT THE COMPANY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LEADING UP TO THAT COMMERCIAL LAUNCH, SO AFTER YOU JOINED THE COMPANY BUT BEFORE EARLY SEPTEMBER 2013, WHAT KIND OF WORK WERE YOU DOING AT THE COMPANY?
ADAM ROSENDORFF: I WAS ACTING ESSENTIALLY AS A CONSULTANT. SO A LOT OF WHAT I WAS DOING WAS TELLING THE R&D GROUP WHAT KIND OF MEASUREMENT RANGE WE NEEDED FOR THE TESTS BASED ON VALUES THAT WOULD BE USEFUL TO CLINICIANS FOR MAKING MEDICAL DECISIONS. I DID CONSULT WITH THE EXECUTIVES IN TERMS OF THE TESTS THAT WE KNEW THAT WE SHOULD BE OFFERING. I DON'T RECALL THE OTHER DUTIES SPECIFICALLY.
MR. BOSTIC: YOU SAID WHEN YOU FIRST JOINED THE COMPANY YOU HAD LIMITED KNOWLEDGE ABOUT THE TECHNOLOGY. DID THAT KNOWLEDGE INCREASE AFTER YOU JOINED THE COMPANY?
ADAM ROSENDORFF: IT DID.
MR. BOSTIC: LET'S TALK ABOUT THE THERANOS DEVICES THAT YOU WERE FAMILIAR WITH. FIRST, DID YOU BECOME FAMILIAR WITH A DEVICE CALLED EDISON?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS THE EDISON DEVICE?
ADAM ROSENDORFF: THE EDISON WAS A SMALL BLACK BOX THAT WAS DESIGNED TO RUN ONE TEST AT A TIME. THE CATEGORY OF TESTS WERE IMMUNOASSAYS. THESE ARE USUALLY LARGER MOLECULES THAT ARE NOT ABLE TO BE MEASURED ON ANALYZERS AND THAT RELIED ON ANTIBODIES FOR THEIR PROTECTION.
MR. BOSTIC: AND DID THERANOS USE THE EDISON DEVICE DURING YOUR TIME AS LAB DIRECTOR?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID THERANOS USE THE EDISON TO TEST PATIENT SAMPLES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO MANUFACTURED THE EDISON?
ADAM ROSENDORFF: THE EDISON WAS MANUFACTURED BY THERANOS IN THEIR NEWARK FACILITY.
MR. BOSTIC: DURING YOUR TIME AT THE COMPANY, DID YOU BECOME FAMILIAR WITH ANY OTHER THERANOS MANUFACTURED BLOOD ANALYZERS?
ADAM ROSENDORFF: I HAD BEEN TOLD ABOUT AN INSTRUMENT CALLED THE MINILAB THAT WAS IN DEVELOPMENT. IT WAS BEING DESIGNED FOR GENERAL CHEMISTRY ASSAYS. AND ALSO ABOUT AN INSTRUMENT CALLED THE 4S, WHICH WOULD BE ABLE TO DO COMPLETE BLOOD COUNTS AMONG OTHER ASSAYS. I WAS NOT FAMILIAR WITH THE INTENDED CAPABILITY OF THOSE INSTRUMENTS IN DEVELOPMENT.
MR. BOSTIC: YOU SAID YOU WERE TOLD ABOUT THOSE INSTRUMENTS. DID YOU EVER DO ANY WORK ON DEVELOPING THOSE INSTRUMENTS?
MR. BOSTIC: AND DID YOU EVER DO ANY WORK ON DEVELOPING OR VALIDATING ASSAYS TO RUN ON THOSE INSTRUMENTS?
MR. BOSTIC: DID YOU EVER SEE EITHER OF THOSE INSTRUMENTS?
MR. BOSTIC: WAS EITHER OF THOSE INSTRUMENTS THAT YOU MENTIONED EVER USED FOR PATIENT TESTING DURING YOUR TIME AT THE COMPANY?
MR. BOSTIC: DID THERANOS RUN ALL OF ITS CLINICAL PATIENT TESTS ON THE EDISON ANALYZER?
ADAM ROSENDORFF: NO, JUST A HANDFUL OF IMMUNOASSAYS. THEY RAN GENERAL CHEMISTRY TESTS ON THE SIEMENS ADVIA USING A LABORATORY DEVELOPED TEST.
MR. BOSTIC: AND WHAT DOES "LABORATORY DEVELOPED TESTS" MEAN?
ADAM ROSENDORFF: LABORATORY DEVELOPED TESTS IS A TEST DEVELOPED WITHIN A SINGLE LABORATORY THAT IS NOT FDA APPROVED. IT USES CUSTOM REAGENTS EITHER MANUFACTURED BY THE LABORATORY OR PURCHASED ELSEWHERE, AND IT HAS TO MEET CERTAIN PERFORMANCE SPECIFICATIONS PER CLIA BEFORE IT CAN BE USED FOR PATIENT CARE.
MR. BOSTIC: AND THE SIEMENS ADVIA THAT YOU MENTIONED, IS IT MANUFACTURED BY THERANOS?
ADAM ROSENDORFF: NO. IT'S MANUFACTURED BY SIEMENS.
MR. BOSTIC: WHY DIDN'T THERANOS CONDUCT ALL OF ITS PATIENT TESTING ON THE EDISON?
ADAM ROSENDORFF: BECAUSE THE EDISON WAS NOT INTENDED TO -- DESIGNED OR INTENDED TO DETECT GENERAL CHEMISTRY SUBSTANCES SUCH AS GLUCOSE OR SODIUM. IT WAS DESIGNED TO DETECT LARGER PEPTIDES AND OTHER ANALYTES, YEAH.
MR. BOSTIC: DID THERANOS MAKE ANY CHANGES TO THE SIEMENS ADVIA THAT IT USED FOR PATIENT TESTING?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WERE THE NATURE OF THOSE CHANGES?
ADAM ROSENDORFF: BECAUSE OF THE SMALL SAMPLE SIZE THAT WAS BEING ACQUIRED IN THE CAPILLARY TUBE AND NANOTAINER DEVICES, THE SIEMENS ADVIA WAS NOT ABLE TO ASPIRATE THAT SAMPLE INTO THE INSTRUMENT BECAUSE THE PROBE COULDN'T GO DOWN FAR ENOUGH AND TO SUCK UP THE SAMPLE. SO THEY DEVELOPED WHAT THEY CALLED THE T-CUP, WHICH WOULD ESSENTIALLY RAISE THE LEVEL OF THAT SAMPLE TO A POINT WHERE THE PROBE OR THE ASPIRATOR COULD SUCK IT UP INTO THE INSTRUMENT. THEY ALSO CHANGED WAVELENGTHS AND DETECTION TIMES ON THE INSTRUMENT, WHICH YOU'RE ABLE TO DO ON THE SO-CALLED OPEN CHANNELS ON THE INSTRUMENTS. SO MOST OF THE TESTS RELY ON ABSORBANCE AT A SPECIFIC WAVELENGTH.
MR. BOSTIC: AND TO USE THOSE THERANOS MODIFIED SIEMENS ADVIA, DID THEY INSERT BLOOD SAMPLES INTO THE MACHINE OR WERE THERE OTHER STEPS THAT CAME BEFORE?
ADAM ROSENDORFF: NO. THE CTN DEVICE WOULD BE SPUN DOWN AND THEN THE SERUM OR PLASMA WOULD BE REMOVED. THAT'S THE CLEAR PORTION OF THE SAMPLE THAT IS FREE OF RED BLOOD CELLS. THAT PORTION WOULD THEN BE DILUTED EITHER WITH SALINE OR WATER TO GIVE A VOLUME THAT WAS COMPATIBLE WITH THE THERANOS TEST.
MR. BOSTIC: I'LL ASK YOU TO LOOK AT THE BINDER IN FRONT OF YOU. THAT'S THE FIRST TAB, 939. THE GOVERNMENT WOULD LIKE TO OFFER THIS INTO EVIDENCE, YOUR HONOR. I UNDERSTAND THE DEFENSE HAVE STIPULATED.
JUDGE DAVILA: IT'S ADMITTED. WOULD YOU LIKE IT PUBLISHED?
MR. BOSTIC: YES, PLEASE.
JUDGE DAVILA: IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 939 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM ELIZABETH HOLMES TO YOU ON AUGUST 3RD, 2013?
ADAM ROSENDORFF: I SEE IT ON THE SCREEN.
MR. BOSTIC: OKAY. IN THAT EMAIL MS. HOLMES SAYS, "YOU'LL OBVIOUSLY NEED TO MAKE SURE OUR MICRO-CUPS AND PROTOCOLS/MODIFICATIONS ARE NOT IN ANY WAY VISIBLE TO ANY SIEMENS REP." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN THE CONTEXT OF WHAT WAS HAPPENING AROUND THIS TIME?
JUROR: YOUR HONOR, IT'S NOT ON OUR SCREENS.
JUDGE DAVILA: OH, IT'S NOT ON THE SCREENS IN THE JURY BOX. PARDON ME A MOMENT, MR. BOSTIC.
MR. BOSTIC: OF COURSE.
COURT CLERK: LET ME DO A RESET. HOLD ON A MINUTE, YOUR HONOR.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: I BELIEVE IT'S ON. YOU MAY CONTINUE, MR. BOSTIC. WHY DON'T YOU START THAT LAST QUESTION AGAIN.
BY MR. BOSTIC:
MR. BOSTIC: THE QUESTION AGAIN WAS, DR. ROSENDORFF, WHAT WAS HAPPENING AROUND THE TIME OF THIS EMAIL?
ADAM ROSENDORFF: SO IN THIS EMAIL, THE MICRO-CUP REFERS TO THE T-CUP OR THERANOS DEVELOPED CUP THAT CONTAINED THE SMALL SAMPLE AND RAISED IT UP. THE PROTOCOLS AND MODIFICATIONS ARE THE ADJUSTMENT TO THE DETECTION TIME AND WAVELENGTHS THAT I REFERRED TO PREVIOUSLY. THESE WERE STORED AS PROGRAMS ON THE SIEMENS INSTRUMENT, AND THE MANAGEMENT DID NOT WANT THOSE PROGRAMS OR THOSE CUPS TO BE VISIBLE TO FIELD SERVICE ENGINEERS OR SIEMENS EMPLOYEES WHEN THEY CAME ON SITE.
MR. BOSTIC: AND WAS THERE GOING TO BE A VISIT OF A SIEMENS REP AROUND THE TIME OF THIS EMAIL?
ADAM ROSENDORFF: I DON'T RECALL.
MR. BOSTIC: LET'S LOOK AT THE NEXT EMAIL UP IN THAT CHAIN. IT WILL BE YOUR RESPONSE TO MS. HOLMES. DO YOU SEE THAT ON THE SCREEN NOW FROM YOU TO MS. HOLMES ON AUGUST 3RD, 2013?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU SAY, "IT WOULD PROBABLY BE BEST IF THE SIEMENS ASSAYS WERE PROGRAMMED BEFORE THE OPEN CHANNEL T ASSAYS." YOU SAY SUBSEQUENT TO THAT, "THE TECHNICAL REP AND THOSE INTERACTING WITH HER, WILL BE MONITORED TO MAKE SURE NOTHING PROPRIETARY IS REVEALED."
ADAM ROSENDORFF: YES.
MR. BOSTIC: CAN YOU EXPLAIN WHAT THIS RESPONSE MEANT?
ADAM ROSENDORFF: WELL, MY RECOLLECTION IS THAT THE THERANOS METHODS -- OUR INSTRUCTIONS WERE TO DELETE THOSE METHODS FROM THE ADVIA BEFORE THE SIEMENS REPS CAME IN.
MR. BOSTIC: WAS IT YOUR UNDERSTANDING AT THIS TIME THAT --
ADAM ROSENDORFF: OH, I'M SORRY. GO AHEAD.
MR. BOSTIC: FINISH YOUR ANSWER, PLEASE, IF YOU HAVE MORE.
ADAM ROSENDORFF: MY RECOLLECTION IS THAT THE REPS WERE MONITORED BY SIEMENS SECURITY DURING THE TIME THAT THEY WERE IN THE UPSTAIRS LABORATORY.
MR. BOSTIC: BY SIEMENS SECURITY?
ADAM ROSENDORFF: NO, BY THERANOS SECURITY.
MR. BOSTIC: AND WAS IT YOUR UNDERSTANDING AT THE TIME THAT THE CHANGES THAT THERANOS HAD MADE TO THESE SIEMENS DEVICES WERE NOT TO BE REVEALED TO THE INDIVIDUALS FROM SIEMENS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: DO YOU HAVE AN UNDERSTANDING OF WHO FIRST PROPOSED OR DEVELOPED THESE CHANGES TO THE SIEMENS DEVICES?
ADAM ROSENDORFF: I FIRST HEARD OF THE PLAN FROM DANIEL YOUNG. I BELIEVE IT WAS HIS IDEA.
MR. BOSTIC: AND DO YOU KNOW WHETHER THE IDEA TO USE THESE THIRD PARTY DEVICES WAS DISCUSSED WITH SUNNY BALWANI, FOR EXAMPLE?
ADAM ROSENDORFF: CAN YOU CLARIFY? I'M SORRY.
MR. BOSTIC: WERE YOU A PART OF ANY DISCUSSIONS INCLUDING SUNNY BALWANI ABOUT THE USE OF THESE THIRD PARTY DEVICES AROUND THIS TIME?
ADAM ROSENDORFF: I DON'T RECALL SPECIFICALLY TALKING TO HIM ABOUT THE PLAN, ABOUT THIS PLAN. I DO RECALL TALKING TO ELIZABETH ABOUT DIFFERENT DILUTION SCHEMES AND WAYS THAT THIS WAS GOING TO BE EXECUTED.
MR. BOSTIC: OKAY. DID -- LET'S SEE. WERE ALL OF THE SIEMENS MODIFIED DEVICES AT THERANOS MODIFIED IN THIS SAME WAY?
ADAM ROSENDORFF: I BELIEVE THAT THE THERANOS LABORATORY DEVELOPED TESTS WERE DIVIDED AMONGST A NUMBER OF SIEMENS INSTRUMENTS. THE GOAL INITIALLY WAS TO HAVE ONE SIEMENS INSTRUMENT BE ABLE TO RUN ALL OF THE THERANOS LABORATORY DEVELOPED TESTS, BUT I DON'T THINK WE WERE ABLE TO DO THAT, SO WE HAD TO DIVVY IT UP AMONGST THE DIFFERENT INSTRUMENTS.
MR. BOSTIC: DID THE CLINICAL LAB AT THERANOS USE ANY THIRD PARTY DEVICES, ANY NON-THERANOS DEVICES THAT WERE UNMODIFIED?
ADAM ROSENDORFF: YES, THEY USED THE SIEMENS ADVIA 1800 IN AN UNMODIFIED MANNER TO BE RUN WITH VENOUS DRAWS FROM VACUTAINERS. THERE WAS AN INSTRUMENT CALLED THE IMMULITE THAT DID IMMUNOASSAY WITH VENOUS DRAWS. THERE WAS ABBOTT CELLDYNE RUBY THAT DID COMPLETE BLOOD COUNTS. THERE WAS AN INSTRUMENT FOR BLOOD LEAD MONITORING. THERE WAS AN INSTRUMENT TO MEASURE AUTO ANTIBODIES. I DON'T REMEMBER THE MANUFACTURER. SO THERE WERE A NUMBER OF THIRD PARTY INSTRUMENTS, YEAH.
MR. BOSTIC: AND THE INSTRUMENTS THAT YOU JUST LISTED, TO YOUR KNOWLEDGE, DID THEY CONTAIN ANY THERANOS-SPECIFIC ENGINEERING OR MODIFICATIONS?
ADAM ROSENDORFF: NO. IT WAS JUST THE ADVIA.
MR. BOSTIC: AT THE THERANOS LOCATION PHYSICALLY, CAN YOU TELL US WHERE THE LAB DEVICES WERE IN THE BUILDING?
ADAM ROSENDORFF: SURE. THERE WAS A LAB UPSTAIRS, SO AT THE GROUND LEVEL THAT CONTAINED THE FDA APPROVED DEVICES, AND THERE WAS A LAB IN THE BASEMENT WHICH CONTAINED LIQUID HANDLERS, EDISONS, ADVIAS THAT HAD BEEN MODIFIED, ET CETERA. FOR A SHORT PERIOD OF TIME THE ADVIA UPSTAIRS WERE MODIFIED TO DO THE THERANOS TESTS, BUT THAT ALL TRANSFERRED TO THE NORMANDY LAB DOWNSTAIRS.
MR. BOSTIC: WHEN YOU SAY THE UPSTAIRS LAB HAD THE FDA APPROVED TESTS, DOES THAT REFER TO THE CONVENTIONAL ANALYZERS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND YOU MENTIONED THE NAME NORMANDY. WHAT DID THAT REFER TO?
ADAM ROSENDORFF: THE DOWNSTAIRS LABORATORY.
MR. BOSTIC: CONTAINING THE THERANOS SPECIFIC DEVICES?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WAS THERE A NAME OR NICKNAME FOR THE UPSTAIRS PORTION OF THE LAB WITH THE CONVENTIONAL DEVICES?
ADAM ROSENDORFF: YES. SUNNY REFERRED TO IT AS JURASSIC PARK BECAUSE HE BELIEVED THE CONVENTIONAL DEVICES WERE DINOSAURS.
MR. BOSTIC: AS LAB DIRECTOR, WERE YOU IN A POSITION TO OVERSEE TESTING IN BOTH OF THOSE LOCATIONS?
ADAM ROSENDORFF: I WAS. HOWEVER, ON AN OPERATIONAL BASIS, NISHIT DOSHI WAS PUT IN CHARGE OF THE LAB.
MR. BOSTIC: AND DID NISHIT DOSHI ESSENTIALLY REPORT TO YOU IN THAT ROLE?
ADAM ROSENDORFF: NO, HE DID NOT.
MR. BOSTIC: AND TO WHOM DID HE REPORT?
ADAM ROSENDORFF: I BELIEVE HE REPORTED TO EITHER SUNNY OR ELIZABETH, BUT I'M NOT SURE.
MR. BOSTIC: DID THE LAB DIRECTOR POSITION, THOUGH, ENCOMPASS ALL OF THE CLINICAL LAB TESTING THAT THERANOS PERFORMED?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND NISHIT DOSHI WAS NOT LAB DIRECTOR; CORRECT?
MR. BOSTIC: PRIOR TO THE COMMERCIAL LAUNCH IN SEPTEMBER OF 2013, WAS THERANOS CONDUCTING ANY PATIENT TESTING?
ADAM ROSENDORFF: YES. THERANOS HAD A CONTRACT WITH SAFEWAY SUPERMARKETS WHERE EMPLOYEES IN PLEASANTON WOULD HAVE BLOOD DRAWN AND THAT WOULD BE TAKEN TO THE THERANOS LABORATORY AND TESTED. MY BELIEF WAS THAT IT WAS VENOUS BLOOD ONLY.
MR. BOSTIC: AND THAT'S WHAT WAS HAPPENING WHEN YOU WERE PRESENT AT THE COMPANY?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: BECAUSE IT WAS VENOUS BLOOD, DOES THAT MEAN IT WAS TESTED ON THE CONVENTIONAL ANALYZERS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND LEADING UP TO THAT COMMERCIAL LAUNCH, THE BROADER COMMERCIAL LAUNCH IN SEPTEMBER OF 2013, WHAT WAS THE OVERALL MOOD AT THE COMPANY?
ADAM ROSENDORFF: THERE WAS A LOT OF ANXIETY WITHIN THE CLIA GROUP REGARDING THE APPROPRIATENESS OF USING THESE MODIFIED TESTS FOR PATIENT CARE. THE GENERAL MOOD OF THE COMPANY WAS FAIRLY OPTIMISTIC. I THINK SOME FOLKS WERE QUESTIONING WHY THERANOS WAS NOT USING ITS OWN DEVICES.
MR. BOSTIC: HOW WOULD YOU DESCRIBE THE PACE OF EVENTS AND THE WORK THAT WAS HAPPENING LEADING UP TO THAT COMMERCIAL LAUNCH?
ADAM ROSENDORFF: EXTREMELY RUSHED AND HURRIED.
MR. BOSTIC: I'LL ASK YOU TO TURN IN YOUR BINDER TO EXHIBIT 3231, PLEASE. TAKE YOUR TIME. LET ME KNOW WHEN YOU GET THERE.
ADAM ROSENDORFF: I HAVE IT.
MR. BOSTIC: DO YOU RECOGNIZE THE DOCUMENT MARKED AS EXHIBIT 3231?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT IS IT?
ADAM ROSENDORFF: THIS IS -- THE EMAIL AT THE TOP OF THE PAGE IS FROM NICHOLAS HAASE. HE WAS IN RESEARCH AND DEVELOPMENT, BUT HE WAS ALSO HEAVILY INVOLVED IN RUNNING THE ADVIA INSTRUMENTS FOR THE VALIDATION, AND HE'S COMMENTING THAT THEY RECEIVED PATHOLOGICAL SAMPLES, BUT THAT THEY'RE ONLY KNOWN TO BE PATHOLOGICAL FOR A SINGLE ANALYTE OR SUBSTANCE, AND THEY WERE GOING TO SCREEN TO SEE IF THEY WERE PATHOLOGICAL FOR ANY ADDITIONAL ANALYTES. SO THIS IS IN REGARD TO THE ANALYTIC RANGE TO MAKE SURE YOU TEST SAMPLES BOTH IN THE NORMAL RANGE AND THE PATHOLOGICAL RANGE.
MR. BOSTIC: I'LL DIRECT YOU TO PAGE 2 OF THAT EXHIBIT, IF I COULD. DOES THIS EMAIL CHAIN BEGIN WITH AN EMAIL FROM ELIZABETH HOLMES TO OTHER EMPLOYEES AT THERANOS?
ADAM ROSENDORFF: YES, I SEE AT THE BOTTOM OF THE PAGE AN EMAIL FROM ELIZABETH TO OTHER EMPLOYEES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES IN EXHIBIT 3231.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN START ON PAGE 2, PLEASE.
(GOVERNMENT'S EXHIBIT 3231 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE THE EMAIL ON THE BOTTOM OF THE SCREEN THAT WE WERE JUST TALKING ABOUT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS MS. HOLMES ASKING FOR IN THIS EMAIL?
ADAM ROSENDORFF: SHE'S ASKING FOR THE TOTAL NUMBER OF GENERAL CHEMISTRY THERANOS LDT ASSAYS THAT HAVE COMPLETED THEIR VALIDATION AS OF TOMORROW, WHICH WOULD HAVE BEEN SEPTEMBER 1ST, ON THE ADVIA AND OTHER PLATFORMS.
MR. BOSTIC: THERE'S A MESSAGE ABOVE THAT FROM PAUL PATEL. WHO WAS HE AT THE COMPANY?
ADAM ROSENDORFF: HE HEADED UP WHAT WAS KNOWN AS COLOR CHEMISTRY. IT WAS THE GENERAL CHEMISTRY R&D TEAM AT THERANOS.
MR. BOSTIC: OKAY. HE INCLUDES ADDITIONAL PEOPLE ON THAT EMAIL, INCLUDING YOURSELF; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND ASKS FOR AN UPDATE; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S TURN TO PAGE 1 OF THE EXHIBIT. IF WE CAN ZOOM IN ON THE MIDDLE OF THE PAGE OF PAGE 1. DO YOU SEE AN EMAIL IN RESPONSE FROM SOMEONE NAMED ROSE EDMONDS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO WAS ROSE EDMONDS AT THERANOS?
ADAM ROSENDORFF: SHE WAS ALSO A RESEARCH AND DEVELOPMENT SCIENTIST INVOLVED IN THE VALIDATIONS.
MR. BOSTIC: THE BEGINNING OF HER EMAIL SAYS, "AS OF RIGHT NOW NONE OF OUR ASSAYS ARE COMPLETELY THROUGH VALIDATION INCLUDING CLINICAL SAMPLE TESTING WITH FINGERSTICK." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN WHAT THIS MEANT AT THIS TIME LEADING UP TO THE LAUNCH?
ADAM ROSENDORFF: SHE'S SAYING THAT NONE OF THE GENERAL CHEMISTRY ASSAYS HAVE COMPLETED VALIDATION.
MR. BOSTIC: AND WHY WAS THAT RELEVANT TO THE UPCOMING LAUNCH, IF IT WAS?
ADAM ROSENDORFF: WELL, IT'S VERY RELEVANT BECAUSE IT'S NINE DAYS BEFORE THE LAUNCH AND NONE OF THE TESTS THAT THE COMPANY WAS INTENDING TO LAUNCH HAD BEEN VALIDATED FOR PATIENT CARE. UNDER CLIA LAW AND ACCORDING TO GOOD LABORATORY PRACTICE, YOU NEED TO VALIDATE A TEST FULLY BEFORE YOU CAN USE IT FOR PATIENT CARE.
MR. BOSTIC: AND WAS THIS SITUATION CONCERNING TO YOU AT THE TIME?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHY WAS THAT IF THERE'S ANYTHING TO ADD FROM WHAT YOU JUST SAID?
ADAM ROSENDORFF: AS I SAID EARLIER, I FELT THAT THE VALIDATION WAS BEING RUSHED AND MORE TIME WOULD HAVE BEEN NEEDED TO MORE THOROUGHLY INVESTIGATE THE THERANOS TECHNOLOGY.
MR. BOSTIC: AS LAB DIRECTOR, WERE YOU THE ONE SETTING THE SCHEDULE FOR VALIDATION IN THE COMMERCIAL LAUNCH?
MR. BOSTIC: AND WHERE WAS THE SCHEDULE COMING FROM?
ADAM ROSENDORFF: ELIZABETH AND SUNNY.
MR. BOSTIC: I'LL ASK YOU TO TURN TO EXHIBIT 1049, PLEASE. YOUR HONOR, THE GOVERNMENT IS OFFERING THIS INTO EVIDENCE. I BELIEVE THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1049 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: IF WE CAN START ON THIS FIRST PAGE AND ZOOM IN ON THE BOTTOM HALF.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL THAT YOU SENT ON AUGUST 29TH, 2013?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND APPROXIMATELY HOW FAR IN ADVANCE OF THE LAUNCH WAS THIS EMAIL SENT?
ADAM ROSENDORFF: NINE DAYS, TEN DAYS.
MR. BOSTIC: AND WHAT WAS THE PURPOSE OF THIS EMAIL? WHAT WERE YOU COMMUNICATING?
ADAM ROSENDORFF: I WAS RAISING THE ALARM BELLS ABOUT ASSAYS THAT I DIDN'T FEEL WERE READY FOR LAUNCH, AND ALSO RAISING SOME CONCERNS ABOUT STAFFING AND TRAINING. THAT'S UNDER NUMBER 2, OPERATIONAL.
MR. BOSTIC: AND WE'LL GET TO THAT IN A SECOND. LET ME ASK, YOU SENT THIS EMAIL TO ELIZABETH HOLMES AND DANIEL YOUNG; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WHY DID YOU SEND IT TO THOSE TWO INDIVIDUALS?
ADAM ROSENDORFF: I FELT IT WAS VERY IMPORTANT FOR ELIZABETH TO BE AWARE OF THESE ISSUES AS THE CHIEF EXECUTIVE OFFICER OF THE COMPANY, AND I'D ALSO EXPRESSED THESE CONCERNS TO DANIEL YOUNG. I WANTED TO REITERATE THEM TO HIM. I HAD LIVE INTERACTION WITH DANIEL DURING THE DAYS -- DURING THE VALIDATION.
MR. BOSTIC: YOU THEN GO ON TO DESCRIBE SOME OF YOUR CONCERNS. CAN YOU WALK US THROUGH THEM? FIRST, WHAT WERE YOUR MEDICAL CONCERNS AT THE TIME?
ADAM ROSENDORFF: MY CONCERN WAS THAT THE REFERENCE RANGE FOR GLUCOSE WAS COMING OUT AS 20 TO 97 ON THE THERANOS CHEMISTRIES, WHEREAS THE REFERENCE RANGE FOR GLUCOSE ON THE SIEMENS CHEMISTRIES WAS 56 TO 117.
MR. BOSTIC: AND APOLOGIES, DR. ROSENDORFF. YOU'RE ON PAGE 2 NOW OF THE EXHIBIT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN GO TO PAGE 2, PLEASE. ZOOM IN ON THE TOP OF THE IMAGE ONCE WE GET THERE. I'M SORRY. GO AHEAD, DR. ROSENDORFF.
ADAM ROSENDORFF: THE TOTAL ALLOWABLE ERROR IS THE SUM OF PRECISION PLUS BIAS, WHICH WAS SET BY CMS AT 10 PERCENT. THE PRECISION WAS ALREADY AT 8 PERCENT, AND THERE WAS SIGNIFICANT NEGATIVE BIAS IN THE GLUCOSE ASSAY, WHICH MEANT THAT WE HAD ALREADY EXCEEDED THE TOTAL ALLOWABLE ERROR. THAT'S WHAT I MEAN BY OUR ENTIRE ERROR BUDGET HAS JUST BEEN SPENT ON PRECISION.
MR. BOSTIC: AND I'LL ASK YOU TO TRANSLATE THAT A LITTLE BIT FOR US. FIRST, WHEN YOU SAY THAT THE PRECISION WAS AS HIGH AS 8 PERCENT, IS HIGH PRECISION OR IS A HIGH PERCENTAGE HERE A DESIRABLE THING OR AN UNDESIRABLE THING?
ADAM ROSENDORFF: NO, UNDESIRABLE.
MR. BOSTIC: AND WHY IS THAT?
ADAM ROSENDORFF: GLUCOSE -- TECHNICALLY GLUCOSE IS A FAIRLY SIMPLE ANALYTE TO MEASURE, AND SO IN TERMS OF THE TECHNIQUE, THE VALUES ON REPEAT MEASUREMENT SHOULD NOT VARY BY THAT MUCH.
MR. BOSTIC: DID THESE NUMBERS CAUSE YOU ANY CONCERN ABOUT THE ACCURACY OR PRECISION OF THE TEST ITSELF?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AT THE BOTTOM OF THAT PARAGRAPH THERE'S A QUESTION FROM YOU THAT SAYS, "MAYBE WE NEED TO WORK ON OUR CALIBRATORS OR CHEMISTRY?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT DID THAT MEAN?
ADAM ROSENDORFF: I SUSPECTED THAT THERE WAS A PROBLEM, A BASIC PROBLEM WITH THE INSTRUMENT'S CALIBRATORS, THE INTERNAL INSTRUMENT CALIBRATORS OR THE REAGENT CHEMISTRY THAT MIGHT EXPLAIN THE NEGATIVE BIAS OF THE TECHNIQUE.
MR. BOSTIC: AND WHAT DOES "NEGATIVE BIAS" MEAN IN THE CONTEXT OF A TEST LIKE THIS?
ADAM ROSENDORFF: IT MEANS THAT WHEN YOU TEST ACTUAL PATIENT SAMPLES, YOU'RE GOING TO GET FALSELY LOW RESULTS.
MR. BOSTIC: AND YOU GO ON TO TALK ABOUT SOME CONCERNS THAT YOU HAVE WITH SODIUM; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN TO US WHAT THOSE CONCERNS WERE?
ADAM ROSENDORFF: SO AT THIS POINT IN TERMS OF PATIENT TESTING, WE HAD DONE SOME TESTING WHERE A FEW PATIENTS HAD SODIUM IN THE 120'S, WHICH IS VERY UNUSUAL FOR SOMEONE WALKING AROUND, A NORMAL PERSON. AS I SAID, 99 PERCENT OF HEALTHY PEOPLE HAVE SODIUMS THAT ARE BETWEEN 135 AND 145, SO TO COME UP -- TO BE TESTED AND HAVE A SODIUM OF 120 IN AN APPARENTLY HEALTHY INDIVIDUAL I JUST DIDN'T BELIEVE.
MR. BOSTIC: AS A LAB DIRECTOR, WOULD YOU SOMETIMES LOOK AT A SINGLE RESULT OR A SMALL NUMBER OF RESULTS AS BEING INDICATIVE OF THE TEST PERFORMANCE?
ADAM ROSENDORFF: THEY WOULD RAISE ALARMS FOR ME. THEY WOULD REQUIRE INVESTIGATION. IF A LARGE NUMBER OF THESE WERE OCCURRING, THAT WOULD BE MORE -- IN MY MIND THAT WOULD BE ESCALATED TO A BIGGER INVESTIGATION.
MR. BOSTIC: BESIDES THE MEDICAL CONCERNS, YOU ALSO HAD OPERATIONAL CONCERNS; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS THE NATURE OF THOSE OPERATIONAL CONCERNS?
ADAM ROSENDORFF: I WAS CONCERNED THAT THE LABORATORY STAFF PERFORMING THE TESTING WAS NOT PROPERLY TRAINED AND THAT WE DID NOT HAVE ENOUGH STAFF TO PERFORM THE TESTS.
MR. BOSTIC: WOULD THOSE PROBLEMS POTENTIALLY HAVE AN IMPACT ON THE ACCURACY OF PATIENT RESULTS?
ADAM ROSENDORFF: YES. IF YOU'RE NOT PROPERLY TRAINED ON A TECHNIQUE, THAT WOULD IMPACT THE RELIABILITY OF THE RESULT.
MR. BOSTIC: GOING BACK BRIEFLY TO THE MEDICAL CONCERNS WHERE YOU SAY "MAYBE WE NEED TO WORK ON OUR CALIBRATORS OR CHEMISTRY." WHO WOULD BE THE PEOPLE ACTUALLY AT THERANOS DOING THAT WORK?
ADAM ROSENDORFF: PAUL PATEL WAS IN CHARGE OF COLOR CHEMISTRY WORKING WITH DANIEL YOUNG ON INSTRUMENT DEVELOPMENT, TEST DEVELOPMENT IN THE CASE OF GLUCOSE. FOR THE IMMUNOASSAYS, I BELIEVE SUREKHA WAS IN CHARGE OF THAT.
MR. BOSTIC: ARE THOSE PEOPLE IN RESEARCH AND DEVELOPMENT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AT THE BOTTOM OF YOUR EMAIL YOU SAY, "I WOULD LIKE US TO BE THE BEST THAT WE CAN BE. A FEW MORE WEEKS TO SORT THROUGH THESE MEDICAL AND LOGISTICAL ISSUES, AND GETTING THE PROPER LEVEL OF TRAINING AND STAFFING WOULD HELP US TREMENDOUSLY." WHAT ARE YOU COMMUNICATING THERE?
ADAM ROSENDORFF: I'M TRYING TO BE AS POLITE AS I CAN AND REALLY WANT THE BEST QUALITY OF TEST RESULTS TO COME OUT OF THE LAB AND FELT THAT WE NEEDED MORE TIME TO SOLVE THESE MEDICAL LOGISTICAL ISSUES, AND IT WOULD ALSO ALLOW US TO TRAIN STAFF MORE THOROUGHLY AND HIRE ADDITIONAL STAFF.
MR. BOSTIC: WOULD THIS MEAN DELAYING THE COMMERCIAL LAUNCH OF THERANOS TESTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: IS THAT A REQUEST THAT YOU MADE LIGHTLY?
MR. BOSTIC: AND THIS EMAIL WAS ADDRESSED TO MS. HOLMES; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHY DID YOU BELIEVE SHE WAS THE CORRECT PERSON TO RECEIVE THIS REQUEST?
ADAM ROSENDORFF: MY UNDERSTANDING WAS THAT SHE WAS ACCOUNTABLE TO THE BOARD OF DIRECTORS AND TO THE INVESTORS AND THAT THE LAUNCH HAD TO BE ESSENTIALLY ON SEPTEMBER -- AS SOON AS POSSIBLE BECAUSE THOSE INDIVIDUALS WERE BECOMING DISSATISFIED WITH THERANOS.
MR. BOSTIC: AND --
ADAM ROSENDORFF: THEY HAD BEEN --
JUDGE DAVILA: SUSTAINED. THAT LAST ANSWER IS STRICKEN. YOU CAN ASK ANOTHER QUESTION.
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, DID YOU HAVE A CONVERSATION WITH MS. HOLMES AROUND THIS TIME ABOUT THIS TOPIC?
ADAM ROSENDORFF: YES, I DID.
MR. BOSTIC: AND WHAT DO YOU RECALL ABOUT THIS CONVERSATION?
ADAM ROSENDORFF: I WENT INTO HER OFFICE. SHE HAD PAPERS STUCK ON TO THE WINDOW WITH A NUMBER ON IT WHICH INDICATED THE NUMBER OF DAYS UNTIL LAUNCH. I EXPRESSED MY CONCERNS TO HER. I TOLD HER THAT THE POTASSIUM WAS UNRELIABLE, THE SODIUM WAS UNRELIABLE, THE GLUCOSE WAS UNRELIABLE, EXPLAINED WHY. SHE WAS VERY NERVOUS. SHE WAS NOT HER USUAL COMPOSED SELF. SHE WAS TREMBLING A LITTLE BIT, HER KNEE WAS TAPPING, HER VOICE WAS BREAKING UP. SHE WAS CLEARLY UPSET.
MR. BOSTIC: YOU READ THAT SHE WAS UPSET. DID SHE SEEM SURPRISED TO BE HEARING ABOUT THESE ISSUES FROM YOU?
ADAM ROSENDORFF: SHE DIDN'T SEEM SURPRISED TO ME. SHE JUST SEEMED NERVOUS AND UPSET.
MR. BOSTIC: YOU MENTIONED EARLIER THAT YOU REPORTED OFFICIALLY, OR MORE DIRECTLY, TO MR. BALWANI; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHY DID YOU GO TO MS. HOLMES WITH THIS INSTEAD OF MR. BALWANI?
ADAM ROSENDORFF: I FELT IT WOULD HAVE MORE IMPACT IN GOING TO ELIZABETH DIRECTLY.
MR. BOSTIC: AND WHY DID YOU FEEL THAT WAY?
ADAM ROSENDORFF: I FELT THAT MANY OF THE CONCERNS THAT I RAISED TO SUNNY WERE -- HE WOULD EITHER DISMISS THEM OR ATTEMPT TO EXPLAIN THEM AWAY OR TELL ME TO GO TALK TO DANIEL YOUNG.
MR. BOSTIC: AND WHAT WAS THE OUTCOME OF THIS CONVERSATION? WAS THE LAUNCH ACTUALLY DELAYED AS YOU WERE REQUESTING?
ADAM ROSENDORFF: NO. ELIZABETH SAID THAT FOR THOSE PROBLEMATIC ASSAYS, WE COULD ALWAYS REVERT TO VACUTAINER DRAWS.
MR. BOSTIC: AND WHAT WOULD THAT MEAN IN TERMS OF WHAT DEVICE WOULD BE DOING THE ANALYSIS?
ADAM ROSENDORFF: THEY WOULD BE RUN ON THE CONVENTIONAL FDA APPROVED INSTRUMENTS.
MR. BOSTIC: INSTEAD OF THE THERANOS DEVICES?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WHEN YOU WERE AT THERANOS, WERE YOU AWARE OF DEMONSTRATIONS THAT WOULD HAPPEN WHERE VIP'S WOULD VISIT THE COMPANY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID YOU HAVE ANY INVOLVEMENT IN RUNNING THE SAMPLES FOR THOSE TECHNOLOGY DEMONSTRATIONS?
ADAM ROSENDORFF: THE SAMPLE WOULD BE COLLECTED IN A FRONT ROOM. I WAS NOT PRESENT FOR THAT. IT WOULD THEN BE TAKEN THROUGH THE LOCKED DOORS INTO THE LABORATORY AND RAN IN THE NORMANDY LAB. MY INVOLVEMENT IN THAT WAS REVIEWING THE RESULTS AFTER THE DEMOS WERE COMPLETE.
MR. BOSTIC: CAN I ASK YOU TO TURN, PLEASE, TO TAB 1157 IN YOUR BINDER. AND ARE YOU LOOKING AT AN EMAIL CHAIN BETWEEN YOU AND OTHER EMPLOYEES AT THERANOS?
ADAM ROSENDORFF: NO. I SEE AN EMAIL AT THE TOP OF THE PAGE FROM DANIEL EDLIN. IS THIS EXHIBIT 1157?
MR. BOSTIC: 1157, UH-HUH.
ADAM ROSENDORFF: AND FROM SAYS DANIEL EDLIN, AND I'M CC'D.
MR. BOSTIC: OKAY. AND ARE THE OTHER INDIVIDUALS ON THIS EMAIL CHAIN EMPLOYEES AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DOES THIS RELATE TO ONE OF THE DEMOS THAT WE'VE BEEN TALKING ABOUT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WERE EMAILS LIKE THESE USED AT THERANOS TO TRACK THE PROGRESS OF THESE DEMOS AND FACILITATE COORDINATION BETWEEN PEOPLE WORKING ON THEM?
ADAM ROSENDORFF: YES, DEFINITELY.
MR. BOSTIC: AND WAS IT IMPORTANT TO CONVEY INFORMATION ACCURATELY IN THESE EMAILS SO THAT THE PROCESS COULD OPERATE CORRECTLY?
ADAM ROSENDORFF: YES, THE EMAILS THAT WE USED TO COORDINATE AMONGST THE DIFFERENT ENTITIES IN THE LABORATORY.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT SUBMITS INTO EVIDENCE 1157.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1157 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN START ON PAGE 2 OF THIS EXHIBIT. LET'S ZOOM IN ON THE BOTTOM MESSAGE.
MR. BOSTIC: DR. ROSENDORFF, ARE YOU LOOKING AT AN EMAIL FROM DANIEL EDLIN TO YOU AND OTHER EMPLOYEES AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO WAS DANIEL EDLIN AT THE COMPANY?
ADAM ROSENDORFF: HE WAS A PROGRAM OR PROJECT MANAGER. HE WAS ALSO INVOLVED IN COMMUNICATING TO OUTSIDE LABS ABOUT POSSIBLE COLLABORATIONS.
MR. BOSTIC: IN HIS EMAIL HE SAYS, "PLEASE NOTE THAT WE HAVE A PATIENT COMING IN TOMORROW MORNING FOR A DEMO." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE SAYS, "PLEASE PLAN TO RUN THE SAME TESTS THAT WE DID FOR LAST WEEK'S PATIENT. TESTS INCLUDE," AND THEN HE LIST SOME ASSAYS; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE THEN SAYS, "SAM AND MICHAEL, WE WILL ALSO NEED TO SET UP MINILABS AND A 4S IN INTERVIEW ROOM NUMBER 1." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S GO BACK TO PAGE 1. AND ZOOM IN ON THE MIDDLE MESSAGE ONCE WE GET THERE. YEAH, FROM THERE DOWN IS GOOD. DO YOU SEE IN THE BOX IN FRONT OF YOU AN EMAIL FROM PAUL PATEL TO YOU AND OTHERS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE SAYS, "DANIEL, ARE WE EXPECTING TO RUN THIS SAMPLE ON ADVIA?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S ZOOM OUT, MS. HOLLIMAN, AND LOOK AT THE EMAIL ABOVE THIS AT THE TOP OF THE PAGE. MR. EDLIN RESPONDS, "PAUL AND TEAM, PLEASE PLAN ON RUNNING THIS SAMPLE USING THE SAME PROCESSES AS LAST WEEK, I.E., THE CURRENT WORKFLOW IN NORMANDY. TO ANSWER PAUL'S QUESTION, I BELIEVE ADVIA IS USED FOR THIS FOR GC ASSAYS?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN WHAT THAT MEANS?
ADAM ROSENDORFF: PAUL IS ASKING DANIEL EDLIN WHAT PROCESS IS -- SHOULD BE USED TO RUN THE DEMO SAMPLES, AND DANIEL EDLIN IS SAYING RUN THEM USING THE SAME PROCESSES AS LAST WEEK WITH THE LDT IN NORMANDY, THE LABORATORY DEVELOPED TESTS IN NORMANDY, THE DOWNSTAIRS LAB. AND HE SAYS HE BELIEVES THAT THE ADVIA IS USED FOR GENERAL CHEMISTRY ASSAYS.
MR. BOSTIC: AND WAS THAT CORRECT TO YOUR RECOLLECTION AT THE TIME? WAS ADVIA USED FOR GENERAL CHEMISTRY?
ADAM ROSENDORFF: YES, IT WAS BEING USED FOR THE LABORATORY DEVELOPED TESTS.
MR. BOSTIC: AND ADVIA WAS NOT A THERANOS MANUFACTURED DEVICE; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S GO BACK TO PAGE 2 NOW, PLEASE, AND BACK TO THAT MESSAGE ON THE BOTTOM HALF OF THE PAGE. I'LL DRAW YOUR ATTENTION TO THE LIST OF ASSAYS THAT WERE GOING TO BE RUN. ARE YOU FAMILIAR WITH THOSE ASSAYS FROM YOUR TIME AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU HAVE AN UNDERSTANDING AS TO WHICH OF THOSE ASSAYS COULD BE RUN ON THE THERANOS MANUFACTURED EDISON?
ADAM ROSENDORFF: ON THE EDISON, SIR?
MR. BOSTIC: CORRECT.
ADAM ROSENDORFF: VITAMIN D, TSH, PSA.
MR. BOSTIC: THE OTHER ASSAYS COULD NOT BE RUN ON THE THERANOS MANUFACTURED DEVICE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WERE ANY OF THESE ASSAYS RUN IN THE CLINICAL LAB ON EITHER THE MINILAB OR THE 4S THAT IS MENTIONED BELOW?
MR. BOSTIC: AND WERE THE MINILAB OR 4S USED TO RUN ANY CLINICAL PATIENT TEST SAMPLES?
MR. BOSTIC: AND WHEN YOU WERE AT THERANOS -- WELL, LET ME ASK, FIRST, YOU SAW PREVIOUSLY THAT YOU WERE INCLUDED ON THIS EMAIL CHAIN HIGHER UP; CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND AT THE TIME, DID IT REGISTER FOR YOU THAT THERE WAS A MISMATCH BETWEEN THE DEVICES THAT WERE GOING TO BE IN THE DEMO ROOM AND THE DEVICES THAT WERE GOING TO BE USED TO ACTUALLY RUN THE SAMPLES?
ADAM ROSENDORFF: I THOUGHT THAT THE 4S AND MINILAB WERE BEING SHOWN TO THE DEMO PARTICIPANTS AS PROTOTYPES. A MORE NEFARIOUS INTERPRETATION WOULD BE THAT --
JUDGE DAVILA: SUSTAINED.
BY MR. BOSTIC:
MR. BOSTIC: AND MY QUESTION, DR. ROSENDORFF, WAS WHETHER YOU ONLY NOTICED WHEN YOU WERE AT THE COMPANY THAT ONE TYPE OF DEVICE WAS IN THE ROOM WHILE ANOTHER TYPE WAS USED TO RUN THE SAMPLES?
ADAM ROSENDORFF: I WASN'T IN THE ROOM. IT REALLY ONLY STRUCK ME DURING MY INTERVIEWS WITH THE GOVERNMENT WHEN I CAREFULLY READ THE EMAILS THAT I FULLY REALIZED WHAT WAS GOING ON IN THE FRONT ROOM.
JUDGE DAVILA: OVERRULED. THAT CAN STAND.
BY MR. BOSTIC:
MR. BOSTIC: I'LL ASK YOU TO LOOK NEXT, PLEASE, AT 1491 IN YOUR BINDER. ONCE YOU HAVE IT, LET ME KNOW IF YOU RECOGNIZE IT AS AN EMAIL SENT BETWEEN THERANOS EMPLOYEES.
ADAM ROSENDORFF: YES. THIS IS AN EMAIL FROM MARK PANDORI TO MAX FOSQUE AT THE TOP OF THE PAGE.
MR. BOSTIC: I'LL ASK YOU TO LOOK AT PAGE 2 OF THAT EXHIBIT. IS THIS ANOTHER EMAIL DEALING WITH A VIP PATIENT SAMPLE AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LIKE THE OTHER EMAIL, WERE EMAILS LIKE THIS SENT AS PART OF YOUR NORMAL PRACTICE TO COORDINATE THESE TESTS AND FACILITATE THE OPERATION OF THE LAB?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1491.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1491 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN GO TO PAGE 2 AND ZOOM IN ON THE BOTTOM MESSAGE.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM MAX FOSQUE TO OTHERS ON JANUARY 28TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: HE WRITES, "PLEASE FOLLOW UP ON WHY BRIAN GROSSMAN HAS NOT BEEN RELEASED YET, HE WAS PENDING AN LDAQ AS OF LAST NIGHT. THIS IS CRITICAL TO GET OUT ASAP." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: MS. HOLLIMAN, LET GO TO THE NEXT PAGE AND CAPTURE THE TOP TWO THIRDS OF THE PAGE. FIRST OF ALL, DR. ROSENDORFF, DO YOU SEE AT THE TOP THAT READS "HI ADAM/MARK"?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THAT EMAIL READS, "THIS PATIENT (BRIAN GROSSMAN) IS A VIP, WOULD YOU MIND LOOKING INTO THE SLOWDOWN HERE? I BELIEVE H. PYLORI IS RUN ON PREDICATE, PERHAPS THERE IS SOME ISSUE WITH THE MACHINE?" WHAT WAS H. PYLORI, FIRST OF ALL?
ADAM ROSENDORFF: HELICOBACTER PYLORI. IT'S A BACTERIA IN THE STOMACH THAT IS ASSOCIATED WITH REFLUX DISEASE. LET'S LEAVE IT THERE.
MR. BOSTIC: AND WHEN THE EMAIL SAYS THAT IT'S RUN ON PREDICATE, WHAT DOES THAT INDICATE?
ADAM ROSENDORFF: THAT IT IS RUN ON AN FDA APPROVED NON-THERANOS DEVICE.
MR. BOSTIC: AND IF WE CAN GO TO PAGE 1 OF THE EXHIBIT, PLEASE. AND IF WE CAN ZOOM IN ON THE TOP HALF OF THE PAGE. THERE'S AN EMAIL FROM MAX FOSQUE TO YOU AND MARK PANDORI. DO YOU SEE THAT AT THE BOTTOM?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IT READS, "THANKS FOR THE UPDATE. PLEASE LET US KNOW THE OUTCOME." THIS IS ON THE IMMULITE; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHAT WAS THE IMMULITE?
ADAM ROSENDORFF: THE IMMULITE IS AN INSTRUMENT MANUFACTURED BY SIEMENS CORPORATION THAT MEASURES -- IT'S AN IMMUNOASSAY INSTRUMENT. IT MEASURES THESE PEPTIDES AND LARGER MOLECULES, SUCH AS VITAMIN D, TSH, ET CETERA, THAT ARE NOT ABLE TO BE MEASURED ON THE ADVIA.
MR. BOSTIC: AND IS THAT THE INSTRUMENT THAT WAS BEING USED TO RUN THIS SIEMENS ADVIA FOR THIS VIP PATIENT AT THE TIME?
ADAM ROSENDORFF: CORRECT. I'D LIKE TO CLARIFY.
MR. BOSTIC: PLEASE.
ADAM ROSENDORFF: THE IMMULITE WOULD HAVE BEEN USED FOR THE HELICOBACTER PYLORI TEST THAT I BELIEVE WAS THE CAUSE OF THE SLOWDOWN FOR RELEASING RESULTS FOR THIS PATIENT BECAUSE ALL OF THE RESULTS WOULD HAVE TO BE COMPLETE BEFORE THE TEST WAS ISSUED, BEFORE THE REPORT WAS ISSUED.
MR. BOSTIC: SO THE REPORT WAS WAITING ON THIS RESULT THAT WAS BEING GENERATED BY A NON-THERANOS DEVICE; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S TALK ABOUT QUALITY CONTROL IF WE COULD. HOW -- IN YOUR EXPERIENCE AT THERANOS AND OTHER LABS, WHAT IS QUALITY CONTROL?
ADAM ROSENDORFF: QUALITY CONTROL IS A METHOD TO DETERMINE WHETHER YOUR INSTRUMENT IS FUNCTIONING PROPERLY BEFORE YOU START TESTING PATIENT SAMPLES.
MR. BOSTIC: AND HOW DOES IT WORK IN A LAB?
ADAM ROSENDORFF: TYPICALLY THE LABORATORY PURCHASES QUALITY CONTROL MATERIALS. IT THEN RUNS THESE MATERIALS A NUMBER OF TIMES TO ESTABLISH AN ACCEPTABLE RANGE FOR THEIR INSTRUMENT, AND THEN THAT RANGE -- SO USUALLY THERE ARE THREE LEVELS OF QUALITY CONTROL MATERIAL THAT SPAN THE CLINICAL REFERENCE RAGE. SO A RANGE IS ESTABLISHED FOR EACH LEVEL, AND THEN BEFORE YOU CAN RUN PATIENT SAMPLES YOU HAVE TO RUN THESE QUALITY CONTROL MATERIALS AND MAKE SURE THAT THE RESULTS ARE WITHIN THOSE RANGES THAT THEY'RE IN.
MR. BOSTIC: AND IN SIMPLE LANGUAGE, WHAT ARE YOU TRYING TO PROVE OR ESTABLISH WITH QUALITY CONTROL?
ADAM ROSENDORFF: YOU'RE TRYING TO PROVE THAT THE INSTRUMENT IS RETURNING ACCURATE RESULTS BEFORE RUNNING PATIENT SAMPLES.
MR. BOSTIC: IS THAT SOMETHING THAT HAS TO BE DONE JUST ONCE FOR EVERY INSTRUMENT AND THEN IT CAN BE USED FOR DAYS AND WEEKS AFTERWARDS ON PATIENT SAMPLES?
ADAM ROSENDORFF: IT HAS TO BE DONE FOR EVERY INSTRUMENT AND FOR EVERY ASSAY TYPE OR TEST TYPE. SOME LABORATORIES WILL DO IT AT THE BEGINNING OF THE DAY, AND SOME LABORATORIES WILL DO IT FOR EACH SHIFT.
MR. BOSTIC: HOW FREQUENTLY DID IT HAPPEN AT THERANOS?
ADAM ROSENDORFF: ONCE A DAY.
MR. BOSTIC: WHAT HAPPENED IF A DEVICE FAILED QUALITY CONTROL FOR A CERTAIN ASSAY?
ADAM ROSENDORFF: THE QUALITY CONTROL WOULD BE REPEATED. IF IT FAILED AGAIN, THE INSTRUMENT WOULD BE TAKEN OUT OF SERVICE AND RECALIBRATED AND QUALITY CONTROL WOULD BE RUN AGAIN TO DETERMINE IF THAT QUALIFICATION PROCESS WAS SUCCESSFUL.
MR. BOSTIC: AS LAB DIRECTOR AT THERANOS, WERE YOU GENERALLY FAMILIAR WITH THE QUALITY CONTROL PERFORMANCE OF THE THERANOS ANALYZERS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS THE QUALITY CONTROL PERFORMANCE OF THOSE ANALYZERS A REPEATED TOPIC OF DISCUSSION AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID THOSE DISCUSSIONS INCLUDE CONVERSATIONS WITH MS. HOLMES ABOUT THAT TOPIC?
ADAM ROSENDORFF: YES.
MR. BOSTIC: I'LL ASK YOU TO LOOK AT EXHIBIT 1214, PLEASE. YOUR HONOR, THE GOVERNMENT WOULD LIKE TO MOVE THIS INTO EVIDENCE. THIS IS SUBJECT TO STIPULATION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1214 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN START AT THE BOTTOM OF PAGE 2. AND LET'S JUST CAPTURE THE HEADER INFORMATION AT THE BOTTOM OF PAGE 2.
MR. BOSTIC: AND WE'RE ABOUT TO LOOK AT THIS EMAIL, DR. ROSENDORFF, BUT DO YOU SEE IT'S FROM SUNNY BALWANI ON SUNDAY, NOVEMBER 3RD, 2013?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND, MS. HOLLIMAN, LET'S GO TO PAGE 3, PLEASE. AND, DR. ROSENDORFF, DO YOU SEE THAT THAT EMAIL WAS SENT TO EMPLOYEES AT THERANOS AND CC'ING ELIZABETH HOLMES?
ADAM ROSENDORFF: YES. IT WAS SENT BY SUNNY BALWANI ON NOVEMBER 3RD, 2013 TO A NUMBER OF EMPLOYEES AND CC'D TO ELIZABETH HOLMES.
MR. BOSTIC: AND IN HIS EMAIL HE SAYS, "I WOULD LIKE THE 2 ADVIAS ON NORMANDY TO BE 100 PERCENT DEDICATED TO CLIA MICRO SAMPLES STARTING THIS WEEK (OR NEXT WEEKEND AT THE LATEST). I WOULD LIKE 1 ADVIA SET UP TO PROCESS ONLY OUR FINGERSTICK/MICRO SAMPLES FOR GC AND OTHER SET UP FOR OUR IMMUNOASSAYS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU HAVE AN UNDERSTANDING OF WHY THIS EXCHANGE WAS BEING REQUESTED AT THIS TIME?
ADAM ROSENDORFF: SUNNY WAS CONCERNED ABOUT INSTRUMENTATION BEING SEPARATED OUT, THAT INSTRUMENTS WOULD NOT BE SHARED BETWEEN THE CLIA LAB AND RESEARCH AND DEVELOPMENT.
MR. BOSTIC: AND LET'S GO TO PAGE 1 OF THIS EXHIBIT. ONCE WE'RE THERE, LET'S ZOOM IN ON THE BOTTOM HALF OF THE PAGE. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM ROSE EDMONDS RESPONDING TO SUNNY ON THIS TOPIC?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND SHE SAYS, "DEAR SUNNY, I AM SOMEWHAT CONCERNED WITH THE FEASIBILITY OF MAKING THIS CHANGE SO QUICKLY. TODAY WE WERE GOING TO START AN EXPERIMENT TO TRY TO HELP TROUBLESHOOT THE ISE VARIABILITY." WHAT DOES ISE STAND FOR?
ADAM ROSENDORFF: ION SELECTIVE ELECTRODE.
MR. BOSTIC: AND WHAT DID THAT REFER TO AT THERANOS?
ADAM ROSENDORFF: THIS IS AN ELECTRODE THAT COMES STANDARD ON THE SIEMENS ADVIA INSTRUMENT THAT MEASURES SODIUM, CHLORIDE, AND POTASSIUM.
MR. BOSTIC: AND DO YOU RECALL AN ISSUE WITH VARIABILITY OF THOSE ASSAYS AROUND THIS TIME?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IS VARIABILITY IN THESE ASSAYS A GOOD THING OR A BAD THING AT A BLOOD TESTING LAB?
ADAM ROSENDORFF: BAD.
MR. BOSTIC: LET'S ZOOM OUT, MS. HOLLIMAN, AND CAPTURE THE TOP HALF OF THE PAGE, PLEASE. DO YOU SEE AT THE BOTTOM OF THAT BOX A MESSAGE FROM SUNNY BALWANI TO DANIEL YOUNG AND ELIZABETH HOLMES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: IT SAYS THERE, "THE ADVIA/GC SCENARIO CONTINUES TO BE A MESS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WERE YOU INCLUDED ON ANY -- WELL, LET ME POINT OUT THAT YOU ARE NOT INCLUDED IN THIS EMAIL CHAIN AT THIS POINT; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WERE YOU INCLUDED IN ANY FOLLOW-UP CONVERSATIONS INVOLVING MR. BALWANI OR MS. HOLMES ON THIS TOPIC?
MR. BOSTIC: LET'S TURN TO EXHIBIT 1342, PLEASE. AND I'LL ASK YOU TO LOOK AT PAGE 6 OF THIS EXHIBIT ONCE YOU GET THERE. ARE YOU LOOKING AT AN EMAIL FROM YOU TO ERIKA CHEUNG ON JANUARY 15, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU TELL US WHAT THE PURPOSE WAS OF THIS EMAIL IN GENERAL TERMS?
ADAM ROSENDORFF: I'M ASKING ERIKA FOR THE QC RANGES FOR VITAMIN D. ERIKA SAID THAT THEY DIDN'T GET A QC RANGE ESTABLISHED FOR VITAMIN D. AND I'M ASKING HER FOR THESE QC RANGES AND I AM ASKING HER TO PUT THE CURRENT AND PRIOR QC RANGES IN A DEDICATED FOLDER IN CLIA.
MR. BOSTIC: AND WAS THIS THE KIND OF TOPIC THAT WAS DISCUSSED BY EMAIL AS PART OF YOUR STANDARD PRACTICE AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS IT PART OF YOUR STANDARD PRACTICE TO USE EMAIL TO CONVEY INFORMATION ON THIS TOPIC AND TO PRESERVE INFORMATION SO THAT IT COULD BE REFERRED BACK TO LATER?
ADAM ROSENDORFF: YES, DEFINITELY.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT OFFERS INTO EVIDENCE EXHIBIT 1432.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1432 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S GO TO PAGE 5 OF THIS EXHIBIT AND ZOOM IN ON THE BOTTOM PORTION.
MR. BOSTIC: DR. ROSENDORFF, YOU TESTIFIED THAT THIS DISCUSSION WAS ABOUT THE VITAMIN D ASSAY; IS THAT CORRECT?
ADAM ROSENDORFF: I'M TRYING TO SEE WHERE -- AH. YES, THIS IS IN REFERENCE TO VITAMIN D, CORRECT.
MR. BOSTIC: AND IN YOUR MESSAGE ON THE SCREEN YOU SAY, "ERIKA THE CV PERCENTAGE AT 18 NANOGRAMS PER MILLILITER IS WAY TOO HIGH AT 33 PERCENT." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHY DID YOU FEEL THAT WAS WAY TOO HIGH AT THAT TIME?
ADAM ROSENDORFF: THE CV FOR VITAMIN D SHOULD BE MUCH LOWER THAN THAT.
MR. BOSTIC: AND WHY IS A HIGH CV PROBLEMATIC?
ADAM ROSENDORFF: IT MEANS THAT, FOR INSTANCE, TWO PATIENTS WITH AN IDENTICAL VITAMIN D LEVEL WOULD GET DIFFERENT RESULTS WITH THE SAME TEST, OR THAT THE PATIENT SAMPLE RESULT WOULD NOT BE REPEATABLE FROM ONE TEST TO ANOTHER.
MR. BOSTIC: YOU GO ON TO SAY ACCORDING TO OUR VALIDATIONS IT SHOULD BE AROUND 20 PERCENT. COULD YOU EXPLAIN WHAT THAT MEANS BETWEEN THE VALIDATIONS AND WHAT YOU WERE LOOKING AT IN THIS INSTANCE?
ADAM ROSENDORFF: YEAH. SO PRECISION OF REPRODUCIBILITY IS REQUIRED BY CLIA AS A VALIDATION, AND IT'S ALSO REQUIRED FOR GOOD LABORATORY PRACTICE. OUR VALIDATIONS HAD INDICATED THAT THE CV'S WERE APPROXIMATELY 20 PERCENT, AND WHAT WE WERE SEEING WITH THE BIORAD QC MATERIAL WAS THAT THE CV'S FOR LEVEL 1 WERE 33 PERCENT, AND THIS IS MUCH HIGHER THAN WHAT WAS REPORTED IN THE VALIDATION.
MR. BOSTIC: AND DOES THE VALIDATION PROCESS COME BEFORE THE ASSAY MOVES INTO THE CLINICAL LAB AND QC BEGINS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS THIS A UNIQUE SITUATION AT THERANOS, SEEING QC PERFORMANCE THAN WAS WORSE THAN AN ASSAY THAT PERFORMED AT THE VALIDATION STAGE?
ADAM ROSENDORFF: I HAD NOT SEEN IT BEFORE.
MR. BOSTIC: AND DID YOU SEE IT AFTER THIS?
ADAM ROSENDORFF: DO YOU MEAN IN SUBSEQUENT LABORATORIES THAT I'VE WORKED IN?
MR. BOSTIC: I MEAN AT THERANOS. DURING YOUR TIME AT THERANOS, WERE THERE OTHER OCCASIONS WHERE YOU SAW LABS PERFORM WORSE IN THE CLINICAL LAB THAN THEY HAD AT VALIDATION?
ADAM ROSENDORFF: MOST DEFINITELY.
MR. BOSTIC: WAS THAT SOMETHING THAT HAPPENED COMMONLY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT THE BOTTOM OF PAGE 3, PLEASE. IF WE CAN CAPTURE THE BOTTOM HALF OF THAT PAGE. DO YOU SEE AN EMAIL FROM SHARADA SIVARAMAN?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO WAS SHARADA SIVARAMAN AT THERANOS?
ADAM ROSENDORFF: AFTER THE DEPARTURE OF SUREKHA, SHARADA WAS PUT IN CHARGE OF THE EDISONS.
MR. BOSTIC: AND SHARADA SAYS THE CV'S ARE HIGH BETWEEN DEVICES. WHAT DOES THAT MEAN IN THIS CONTEXT?
ADAM ROSENDORFF: SO THIS WOULD REFER TO INTRO RUN PRECISION, WHERE YOU RUN A SAMPLE ON DIFFERENT DEVICES ON DIFFERENT DAYS, AND SHE'S SAYING THAT THE PRECISION OR THE CV'S ARE HIGH WHEN YOU COMPARE THE RESULTS FROM ONE DEVICE TO ANOTHER.
MR. BOSTIC: AND WAS THAT A GOOD THING OR A BAD THING?
ADAM ROSENDORFF: BAD.
MR. BOSTIC: AND WHY IS THAT SOMETHING THAT YOU DON'T WANT TO SEE AT A LAB?
ADAM ROSENDORFF: YOU REALLY WANT TO MAKE SURE THAT REGARDLESS OF WHAT INSTRUMENT YOU PICK TO RUN THE TEST, THAT IT GIVES A SIMILAR RESULT. IF THOSE RESULTS ARE NOT CLOSE TOGETHER, THAT INDICATES A PROBLEM IN THE LABORATORY.
MR. BOSTIC: AND SHARADA'S EMAIL GOES ON TO SAY, "SINCE WE ARE ALLOWED TO REMOVE 2 DATA POINTS FROM 6 (1 CARTRIDGE OUT OF 3), I HAVE ATTEMPTED TO DO THAT WITH BOTH THE LEVEL 1 AND 2 DATA AND IT IMPROVES THINGS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND ARE YOU FAMILIAR WITH THE PRACTICE THAT THIS WAS REFERRING TO?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WHAT WAS THIS PRACTICE AT THERANOS?
ADAM ROSENDORFF: SO AT THIS POINT IN TIME TWO EDISON -- I'M SORRY, THREE EDISON MACHINES WOULD BE USED FOR A SINGLE PATIENT TEST AND IT WOULD GENERATE SIX DATA POINTS BECAUSE EACH MACHINE HAD TWO TIPS IN IT, AND THE PROCEDURES ALLOW FOR REMOVAL OF TWO OF THOSE DATA POINTS FROM THE SIX DATA POINTS WHEN EVALUATING QC.
MR. BOSTIC: YOU SAID THAT THREE THERANOS DEVICES WERE USED FOR EVERY PATIENT TEST; IS THAT CORRECT?
ADAM ROSENDORFF: AT THE -- YES, AT THIS TIME, YES.
MR. BOSTIC: AND WHAT WAS THE PURPOSE AS YOU UNDERSTOOD IT OF USING THREE THERANOS ANALYZERS TO PERFORM ONE TEST?
ADAM ROSENDORFF: IT WAS FELT THAT AVERAGING RESULTS OF THE SIX DATA POINTS WOULD GIVE MORE ACCURATE RESULTS.
MR. BOSTIC: AND WAS IT ABOUT DECREASING THAT CV NUMBER?
ADAM ROSENDORFF: SO ON A CLINICAL LEVEL YOU LOOK AT A TEST SYSTEM. THE TEST SYSTEM WOULD HAVE BEEN THE THREE EDISONS. YOU COMPARE -- YOU EVALUATE THE CV ON THAT TEST SYSTEM VERSUS ANOTHER TEST SYSTEM. THIS CV HAS TO DO WITH WHAT THEY'RE OBSERVING IN TERMS OF WHAT -- THE VALUE THAT EACH TIP IS PUTTING OUT.
MR. BOSTIC: LET'S LOOK AT YOUR EMAIL IN RESPONSE TO THIS AT THE TOP OF PAGE 3. YOU SAY THERE, "SHARADA, SINCE 3 DEVICES ARE BEING USED AS ONE TESTING SYSTEM, FOR PURPOSES OF QC WE MUST CONSIDER THEM AS ONE TESTING SYSTEM/DEVICE." IS THIS WHAT YOU WERE JUST REFERRING TO?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IN THE PARAGRAPH BELOW THAT YOU ASK, "WHICH 2 DATA POINTS, WHICH (1 OUT OF 3 CARTRIDGES) SHOULD WE REMOVE FROM THE DATA SET FOR QC GOING FORWARD? IS THERE A PROTOCOL FOR THIS?" DO YOU SEE THAT QUESTION?
ADAM ROSENDORFF: YES. YES.
MR. BOSTIC: AND LET'S TURN TO PAGE 1, PLEASE, OF THIS EXHIBIT AND SEE THE ANSWER. LET'S ZOOM IN ON THE TEXT OF SHARADA'S EMAIL IN THE MIDDLE OF THE PAGE. DO YOU SEE THE LANGUAGE IN THE SECOND PARAGRAPH WHERE SHE RESPONDS TO YOU TO SAY, "AT THIS TIME OUR OUTLIER REMOVAL PROCEDURE IS MANUAL"?
ADAM ROSENDORFF: I SEE THAT.
MR. BOSTIC: SHE SAYS, "(WE CAN MOVE 2 OUT OF THE 6 DATA POINTS) AND IT ALSO DEPENDS ON THE DATA SET." AM I READING THAT CORRECTLY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND SHE SAYS BELOW THAT, "I CHOSE THE CARTRIDGES IN GREEN FOR EXCLUSION SINCE THEY IMPROVED CONC CV'S." WHAT IS CONC CV'S?
ADAM ROSENDORFF: CONCENTRATION CV'S AS OPPOSED TO RLU CV'S.
MR. BOSTIC: AND WHAT WOULD THAT REFER TO AS THE SECOND ONE?
ADAM ROSENDORFF: THERE'S A PHOTO MAGIC DETECTOR AND INSTRUMENT THAT JUST DETECTS THE LIGHT THAT IS COMING OFF THE TIP DURING THE ANALYTE DETECTION. SO THAT SIGNAL IS TRANSLATED TO AN ACTUAL CONCENTRATION USING A CALIBRATION CURVE.
MR. BOSTIC: DURING YOUR TIME AT THERANOS, DID YOU HAVE AN UNDERSTANDING AS TO HOW THIS MANUAL DATA DELETION ACTUALLY FUNCTIONED IN PROCESS?
ADAM ROSENDORFF: I WAS CONCERNED WE DIDN'T HAVE A PROTOCOL FOR IT. I ASKED DANIEL ABOUT IT AND HE SAID IT WAS GOING TO BE PART OF AN ALGORITHM ON THE EDISON 3.5.
MR. BOSTIC: AND BEFORE THAT ALGORITHM WAS TO COME OUT, WERE YOU AWARE OF ANY RULES THAT WERE USED TO SELECT WHICH POINTS TO REMOVE FROM THE DATA SET?
MR. BOSTIC: ARE YOU AWARE GENERALLY OF RULES ABOUT THE TREATMENT OF OUTLIERS IN DATA SETS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: BUT TO YOUR KNOWLEDGE, YOU DIDN'T SEE THOSE BEING USED IN THIS PROCESS AT THERANOS?
MR. BOSTIC: AT THERANOS YOU WORKED WITH OTHER COMMERCIAL ANALYZERS BESIDES JUST THE EDISONS; CORRECT?
ADAM ROSENDORFF: I'M SORRY. YOU SAID COMMERCIAL ANALYZERS BESIDES THE EDISONS? THE EDISON WASN'T A COMMERCIAL.
MR. BOSTIC: GOOD POINT. THANK YOU. I MISSPOKE.
ADAM ROSENDORFF: NO PROBLEM.
MR. BOSTIC: AT THERANOS YOU WORKED WITH OTHER BLOOD ANALYZERS BESIDES THE EDISONS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND SPECIFICALLY THE COMMERCIAL ANALYZERS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND DID YOU ALSO HAVE OCCASION TO WORK WITH SOME COMMERCIAL NON-THERANOS ANALYZERS WHEN YOU WERE AT UNIVERSITY OF PITTSBURGH AT THAT LAB?
ADAM ROSENDORFF: YES.
MR. BOSTIC: FROM THAT WORK, DO YOU HAVE AN UNDERSTANDING OF WHETHER THOSE DEVICES USED THE SAME APPROACH, THAT IS, WHETHER THEY RUN THE TEST MULTIPLE TIMES, DISREGARD SOME RESULTS, AND THEN TAKE AN AVERAGE OF THE REMAINDER?
ADAM ROSENDORFF: NO, THEY DID NOT.
JUDGE DAVILA: I DON'T THINK SO. I DON'T THINK THAT CALLS FOR 702.
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, YOUR ANSWER TO THAT QUESTION -- THE QUESTION WAS BASED ON YOUR KNOWLEDGE HAVING WORKED WITH THOSE DEVICES, DO THOSE COMMERCIAL DEVICES USE THE SAME APPROACH OF TAKING MULTIPLE DATA POINTS, REMOVING SOME AND THEN AVERAGING THE REST?
ADAM ROSENDORFF: NO, THEY DO NOT.
MR. BOSTIC: GOING BACK TO EXHIBIT 1342 FOR A MOMENT. LET'S ZOOM IN ON THE TOP MESSAGE ON THAT PAGE. THIS IS THE FINAL EMAIL IN THIS EXHIBIT. YOU WRITE TO SHARADA, "YES, I AGREE WITHIN-INSTRUMENT PRECISION IS GOOD BUT THE BETWEEN INSTRUMENT PRECISION IS NOT." YOU SAY, "THIS MIGHT BE A MANUFACTURING ISSUE." CAN YOU EXPLAIN WHY YOU THOUGHT A MANUFACTURING ISSUE MIGHT HAVE BEEN THE ROOT CAUSE OF THIS?
ADAM ROSENDORFF: WELL, FIRST OF ALL, THE VALIDATION WAS DONE USING ONE EDISON. WE WERE NOW USING THREE. THE FACT THAT WE WERE USING THREE WOULD REVEAL DIFFERENCES IN INSTRUMENT PERFORMANCE FROM ONE INSTRUMENT TO ANOTHER. THAT COULD POINT TO A HARDWARE ISSUE OR SOME KIND OF MECHANICAL ISSUE IN THE INSTRUMENTS. ALTERNATIVELY IT COULD POINT TO NONSTANDARDIZATION IN THE ACTUAL REAGENTS, THAT THE REAGENT CARTRIDGES USED ON EACH INSTRUMENT MIGHT BE DIFFERENT AND THAT MIGHT BE A MANUFACTURING PROBLEM IN NOT MAKING SURE THAT THE REAGENTS ARE EQUIVALENT WITH EACH CARTRIDGE.
MR. BOSTIC: ARE YOU SAYING THAT THE THREE THERANOS ANALYZERS WORKING ON THE SAME SAMPLE WOULD DISAGREE ON WHAT THE RESULT WAS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU SAID THIS MIGHT HAVE BEEN RELATED TO THE MANUFACTURING OF THE REAGENTS; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO MANUFACTURED THE REAGENTS?
ADAM ROSENDORFF: THERANOS. OR MANUFACTURING OF THE INSTRUMENTS THEMSELVES.
MR. BOSTIC: EITHER THE REAGENTS OR THE DEVICES THEMSELVES?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: OKAY. WE CAN PUT THAT EXHIBIT ASIDE. LET'S MOVE TO EXHIBIT 1525, PLEASE. YOUR HONOR, THE GOVERNMENT MOVES THIS INTO EVIDENCE SUBJECT TO STIPULATION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1525 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S START, PLEASE, WITH PAGE 4, AND ZOOM IN ON THE BOTTOM MESSAGE, PLEASE.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE A MESSAGE FROM ERIKA CHEUNG TO YOU AND OTHERS AT THERANOS ON FEBRUARY 10TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE SUBJECT LINE IS QC FOR TSH FAILED AFTER RERUN. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT IS BEING COMMUNICATED IN THIS FIRST EMAIL?
ADAM ROSENDORFF: THE LEVEL 1 HAD BEEN RUN FOR TSH ONCE AND ERIKA IS SAYING SHE RAN THE LEVEL 1 AGAIN AND IT FAILED AGAIN. SORRY, GO AHEAD.
MR. BOSTIC: NO, DON'T LET ME CUT YOU OFF.
ADAM ROSENDORFF: I CAN ADDRESS THE SECOND PART OF HER EMAIL IF THAT IS NEEDED.
MR. BOSTIC: YES, PLEASE, EXPLAIN THE CONTEXT FOR THE SECOND PART.
ADAM ROSENDORFF: THE REAGENT CARTRIDGES WOULD EITHER BE FILLED MANUALLY OR THEY WOULD BE FILLED IN AUTOMATIC FASHION, AND THAT WAS CALLED CAPSYS. SO THERE WERE TWO KINDS OF REAGENT CARTRIDGES.
MR. BOSTIC: DURING YOUR TIME AT THERANOS, DID YOU SEE ISSUES REGULARLY WHERE ASSAYS ON THE EDISON FAILED QC?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS IT A RARE OR A COMMON OCCURRENCE?
ADAM ROSENDORFF: COMMON.
MR. BOSTIC: WAS IT COMMON ENOUGH TO CREATE PROBLEMS IN THE LAB?
ADAM ROSENDORFF: YES. BECAUSE OF THE HIGH RATE OF QC FAILURE AND THE NEED FOR FREQUENT RECALIBRATION, IT WOULD RESULT IN BACKLOGS. AND IT ALSO WAS OF CONCERN TO ME REGARDING THE ACCURACY OF THE ACTUAL RESULTS THAT WERE COMING OUT.
MR. BOSTIC: YOUR HONOR, I WOULD LIKE TO PUBLISH EXHIBIT 1633. I BELIEVE IT'S ALREADY IN EVIDENCE.
JUDGE DAVILA: ALL RIGHT. THAT MAY BE PUBLISHED.
BY MR. BOSTIC:
MR. BOSTIC: LET'S LOOK AT -- FIRST OF ALL, ZOOM IN ON THE BOTTOM OF THE PAGE, PLEASE. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM LANGLY GEE TO MARK PANDORI, YOU, AND OTHERS AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE SAYS, "THE OTHER DAY YOU ASKED FOR A NUMBER OF FAILED QC ELISA RUNS. FOR MARCH, 26 PERCENT RUNS FAILED." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S GO TO PAGE 2 OF THIS EXHIBIT, PLEASE. AND LET'S ZOOM IN ON THAT TABLE. DR. ROSENDORFF, WHAT IS BEING DEPICTED IN THE TABLE ON EXHIBIT 1633?
ADAM ROSENDORFF: SO WHAT IS BEING SHOWN IN THE LEFT COLUMN IS THE ASSAY. EACH ASSAY IS -- QC IS RUN USING THREE LEVEL -- I'M SORRY, TWO LEVELS, A LOW LEVEL AND A HIGH LEVEL. THAT'S IN COLUMNS 2 AND 3. SO THE NUMBER OF LOW LEVEL QC'S RUN IS SHOWN AND THE NUMBER OF HIGH LEVEL QC'S IS SHOWN FOR EACH ANALYTE, THE TOTAL NUMBER OF RUNS, AND THEN THE FAR RIGHT COLUMN IS THE PERCENTAGE OF QC FAILURES AS A PERCENTAGE OF THE TOTAL RUNS.
MR. BOSTIC: AS LAB DIRECTOR OF THERANOS, DID YOU GENERALLY HAVE A SENSE OF HOW THE EDISONS WERE PERFORMING IN QC?
ADAM ROSENDORFF: YES.
MR. BOSTIC: THE DATA THAT WE'RE LOOKING AT AND THESE SPECIFIC FAILURE RATES, ARE THESE TYPICAL FAILURE RATES BASED ON YOUR EXPERIENCE WITH THE EDISON AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND SO, IN OTHER WORDS, MARCH WAS NOT AN ESPECIALLY BAD MONTH. THIS IS WHAT YOU WOULD SEE REGULARLY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LOOKING AT THESE ACTUAL FAILURE RATES, WAS THIS VIEWED AS ACCEPTABLE PERFORMANCE OR BAD PERFORMANCE AT THERANOS AT THE TIME?
ADAM ROSENDORFF: CAN YOU CLARIFY? BY WHOM?
MR. BOSTIC: LET'S START WITH YOU. WHEN YOU WERE LAB DIRECTOR, DID YOU VIEW THIS PERFORMANCE AS ACCEPTABLE?
ADAM ROSENDORFF: NO, IT WAS NOT ACCEPTABLE.
MR. BOSTIC: OKAY. CAN YOU EXPLAIN WHY?
ADAM ROSENDORFF: THE QC FAILURE RATE SHOULD BE MUCH LOWER.
MR. BOSTIC: AND WHY --
ADAM ROSENDORFF: I WOULD SAY WITH THE EXCEPTION OF TSH, THAT'S A --
MR. BOSTIC: AND WHY AS LAB DIRECTOR WOULD YOU WANT TO SEE LOWER QC FAILURE RATES?
ADAM ROSENDORFF: WELL, THERE'S A PRACTICAL CONSIDERATION OF BEING ABLE TO RUN THE ASSAY AND NOT HAVE TO RECALIBRATE, AND THEN THERE'S THE CONCERN THAT HIGH QC FAILURE RATES WOULD INDICATE A PROBLEM WITH THE ACCURACY OF THE TEST ITSELF.
MR. BOSTIC: YOU TESTIFIED EARLIER THAT WHEN A DEVICE FAILED QC FOR A CERTAIN ASSAY, IT WOULDN'T BE USED AGAIN UNTIL THE PROBLEM WAS SOLVED; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WHY DIDN'T THAT ADDRESS YOUR CONCERNS ABOUT THE ACCURACY OF THE ASSAYS? WOULDN'T THAT SAFEGUARD BE ENOUGH TO PREVENT INACCURATE RESULTS GOING OUT THE DOOR?
ADAM ROSENDORFF: WE WERE FOLLOWING STANDARD LABORATORY PRACTICE IN THE SENSE THAT WE WOULD NOT REPORT PATIENT RESULTS UNTIL THE QC HAD FAILED. HOWEVER, BECAUSE THE QC WAS FAILING SO FREQUENTLY, IT, IT RAISED DOUBTS IN MY MIND REGARDING THE ACCURACY OF THE TESTS THEMSELVES. IN OTHER WORDS, FROM -- BETWEEN QC RUNS YOU COULD STILL HAVE AN INACCURATE RESULT. QC ALONE WOULD NOT BE -- PARTIAL QC ALONE WOULD NOT BE SUFFICIENT TO INDICATE AN INACCURATE TEST.
MR. BOSTIC: I SEE. BECAUSE YOU COULD STILL HAVE CONCERNS ABOUT THE PATIENT RESULTS THAT WERE GOING OUT IN BETWEEN THE QC CHECKS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: FROM YOUR WORK AT THERANOS WITH NON-THERANOS ANALYZERS AND FROM YOUR TIME AT OTHER LABS, DID YOU HAVE A SENSE OF HOW NON-THERANOS ASSAYS PERFORMED IN QC?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HOW DID THE THERANOS ASSAY PERFORMANCE COMPARE TO THE NON-THERANOS ASSAY PERFORMANCE WHEN IT CAME TO QC?
ADAM ROSENDORFF: SO IN GENERAL IMMUNOASSAY, QC ARE HIGHER THAN GENERAL CHEMISTRY RATES. HOWEVER, THE IMMUNOASSAY QC FAILURE RATES SHOULD BE SINGLE DIGITS.
MR. BOSTIC: AND DID YOU, IN FACT, SEE THAT KIND OF SUPERIOR PERFORMANCE FROM NON-THERANOS ANALYZERS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 1772, PLEASE. YOUR HONOR, THE GOVERNMENT OFFERS THIS INTO EVIDENCE. IT HAS BEEN STIPULATED TO.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1772 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S START AT PAGE 3 OF THIS EXHIBIT, PLEASE, MS. HOLLIMAN. IF WE CAN ZOOM IN ON THE MIDDLE OF THE PAGE.
MR. BOSTIC: THERE'S AN EMAIL FROM ROMINA RIENER TO YOU. DO YOU SEE THE CONTENT IN FRONT OF YOU.
ADAM ROSENDORFF: CAN YOU REPEAT THE EXHIBIT NUMBER? IS THAT 1772?
MR. BOSTIC: 1772, AND WE'RE ON PAGE 3.
ADAM ROSENDORFF: OKAY.
MR. BOSTIC: DO YOU SEE THE CONTENT OF AN EMAIL TO YOU ON JUNE 11TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT IS BEING CONVEYED HERE?
ADAM ROSENDORFF: ON THE LEFT COLUMN ARE THE IMMUNOASSAYS BEING RUN AT THIS TIME ON THE EDISON; AND THE NEXT COLUMN IS THE NUMBER OF EDISON READERS DEDICATED TO EACH ASSAY, IN OTHER WORDS, ONE READER, ONE ASSAY; THE NEXT COLUMN INDICATES HOW MANY OF THESE READERS PASS BOTH QC LEVELS; AND THE LAST COLUMN ARE NOTES.
MR. BOSTIC: IN ORDER TO BE USED FOR PATIENT TESTING, DID EACH OF THESE MACHINES HAVE TO PASS BOTH QC LEVELS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: SO, FOR EXAMPLE, IF WE LOOK AT THE ROW FOR T PSA, DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT IS THE T PSA?
ADAM ROSENDORFF: TOTAL PROSTATE SPECIFIC ANTIGEN.
MR. BOSTIC: AND HOW IS THAT USED MEDICALLY?
ADAM ROSENDORFF: A HIGH LEVEL CAN INDICATE CANCER.
MR. BOSTIC: FOR T PSA THERE WAS A TOTAL NUMBER OF THREE READERS ADDRESSED IN THIS CHART; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND ARE THESE EDISONS WE'RE TALKING ABOUT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HOW MANY OF THOSE THREE PASS THE BOTH QC LEVELS AT THAT TIME?
ADAM ROSENDORFF: ONE.
MR. BOSTIC: ONE OUT OF THREE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: I'LL DRAW YOUR ATTENTION TO VITAMIN D DOWN AT THE BOTTOM OF THE TABLE.
ADAM ROSENDORFF: YES.
MR. BOSTIC: HOW WAS THE VITAMIN D TEST USED IN PRACTICE?
ADAM ROSENDORFF: VITAMIN D IS A NECESSARY VITAMIN FOR GENERAL HEALTH.
MR. BOSTIC: GO AHEAD.
ADAM ROSENDORFF: IT'S IMPORTANT FOR BONE HEALTH IN PARTICULAR.
MR. BOSTIC: AND HOW MANY READERS WERE BEING ADDRESSED IN THIS TABLE THAT COULD BE PERFORMED VITAMIN D?
ADAM ROSENDORFF: FOUR.
MR. BOSTIC: AND OUT OF THE FOUR, HOW MANY PASSED QC LEVELS AND COULD ACTUALLY BE USED FOR PATIENT TESTS?
ADAM ROSENDORFF: ZERO.
MR. BOSTIC: LET'S MOVE FORWARD TO THE FIRST PAGE OF THIS EXHIBIT. LET'S ZOOM IN ON THE MIDDLE MESSAGE, PLEASE. IS THIS AN EMAIL FROM YOU TO SUNNY BALWANI ON JUNE 11TH, 2014?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: THE TITLE OR THE SUBJECT OF THIS EMAIL IS EDISON BACKLOGS; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND UNDER IMPORTANCE IT SAYS HIGH. WHAT DOES THAT MEAN?
ADAM ROSENDORFF: I'M INDICATING THE HIGH IMPORTANCE OF THIS EMAIL.
MR. BOSTIC: WHAT WAS THE PURPOSE OF SENDING THIS EMAIL TO SUNNY BALWANI? WHAT WERE YOU TRYING TO COMMUNICATE?
ADAM ROSENDORFF: SUNNY HAD INSTRUCTED THE CLIA LABORATORY TO ALIQUOT BLOOD FROM VACUTAINERS INTO CTN'S AND TO RUN THEM ON THE EDISONS. THIS WAS RESULTING IN A LARGER NUMBER OF EDISON TESTS THAN WOULD HAVE OCCURRED IF THOSE -- THAT BLOOD WAS RUN ON THE PREDICATE INSTRUMENTS. I'M INDICATING TO HIM THAT THERE'S A BACKLOG OF 23 PENDING TESTS, 9 OF THEM WERE DUE TO THIS ALIQUOTING PROCEDURE THAT I JUST DESCRIBED. I'M SAYING THAT THE TESTS -- THAT THE TESTING WOULD LIKELY END AT 11:00 P.M. AND I'M SUGGESTING TO HIM TO SUSPEND THIS PRACTICE OF ALIQUOTING FROM THE VACUTAINERS INTO THE CTN.
MR. BOSTIC: AND JUST BRIEFLY, WHAT IS THE CTN?
ADAM ROSENDORFF: CAPILLARY TUBE AND NANOTAINER. IT IS THE PROPRIETARY THERANOS DEVICE THAT --
MR. BOSTIC: AND BY BACKLOG OF EDISON TESTS, DOES THAT MEAN THAT THERE WERE DELAYS IN THE LAB?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WERE THESE DELAYS EXACERBATED BY THE FACT THAT SOME EDISON ANALYZERS COULDN'T BE USED BECAUSE THEY FAILED QC?
ADAM ROSENDORFF: THAT WAS THE REASON.
MR. BOSTIC: WAS THAT A COMMON OCCURRENCE IN THE LAB THAT SO MANY EDISONS WOULD FAIL QC THAT DELAYS WOULD RESULT BECAUSE NOT ENOUGH MACHINES WOULD BE AVAILABLE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S LOOK AT THE TOP MESSAGE IN THIS CHAIN, PLEASE, MS. HOLLIMAN. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM SUNNY BALWANI TO MS. HOLMES AND OTHERS ON JUNE 12TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE THE IMPORTANCE IS MARKED HIGH IN THIS EMAIL AS WELL?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE HE SAYS IN THE FIRST LINE, "WE NEED THIS MESS RESOLVED ASAP?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND, YOUR HONOR, WAS THE COURT THINKING OF A BREAK AROUND THIS TIME?
JUDGE DAVILA: I WAS. ARE YOU FINISHED WITH THIS EXHIBIT?
MR. BOSTIC: THIS MAY BE A GOOD STOPPING POINT, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. LET'S TAKE OUR MORNING BREAK, LADIES AND GENTLEMEN OF THE JURY, 30 MINUTES, PLEASE. SIR, YOU CAN STEP DOWN AND WE'LL COME BACK.
(JURY OUT AT 10:45 A.M.)
(RECESS FROM 10:45 A.M. UNTIL 11:21 A.M.)
JUDGE DAVILA: THANK YOU. WE'RE BACK ON THE RECORD IN UNITED STATES VERSUS HOLMES. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. BEFORE YOU BEGIN YOUR EXAMINATION, I APOLOGIZE, BUT I NEED TO MAKE A COMMENT HERE THAT IT'S BEEN BROUGHT TO MY ATTENTION THAT, LADIES AND GENTLEMEN, WE HAVE PERMITTED AND WE WILL PERMIT LAPTOPS AND OTHER TYPES OF DEVICES IN THE AUDIENCE IN THE GALLERY, BUT ANY KEYBOARD MUST BE A SILENT KEYBOARD. ONLY SILENT KEYBOARDS ARE PERMITTED DURING THIS PROCESS. IF YOU DO NOT HAVE A SILENT KEYBOARD ON YOUR DEVICE, YOU MUST CLOSE YOUR CLAMSHELL, TURN THAT OFF, AND NOT USE IT. IF YOU HAVE QUESTIONS ABOUT WHETHER YOUR DEVICE IS A SILENT KEYBOARD OR NOT, PLEASE RAISE YOUR HAND AND I WILL SUMMON A UNITED STATES MARSHAL WHO CAN HELP YOU TO DETERMINE WHAT TYPE OF DEVICE YOU HAVE.
(LAUGHTER.)
JUDGE DAVILA: PLEASE CLOSE YOUR CLAMSHELLS. SILENT KEYBOARDS ONLY. PARDON ME, MR. BOSTIC. YOU MAY CONTINUE WITH YOUR EXAMINATION.
MR. BOSTIC: THANK YOU, YOUR HONOR.
MR. BOSTIC: WELCOME BACK, DR. ROSENDORFF.
ADAM ROSENDORFF: THANK YOU.
MR. BOSTIC: YOU CAN REMOVE YOUR MASK IF YOU'RE COMFORTABLE DOING SO. MS. HOLLIMAN, IF WE CAN PUT BACK EXHIBIT 1772 ON THE SCREEN. I BELIEVE THIS WAS ADMITTED INTO EVIDENCE. AND IF WE COULD ZOOM IN ON THE TOP MESSAGE, PLEASE. DR. ROSENDORFF, DO YOU RECALL OUR DISCUSSION A MOMENT AGO ABOUT THIS EMAIL IN JUNE OF 2014 RELATING TO THE EDISON BACKLOG?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND OUR PREVIOUS DISCUSSION ABOUT QUALITY CONTROL FAILURES AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AROUND THIS TIME, IN THE MIDDLE OF 2014, WERE YOU PART OF ANY DISCUSSIONS THAT INCLUDED MS. HOLMES ABOUT THE QUALITY CONTROL FAILURES AT THERANOS?
ADAM ROSENDORFF: YES, I WAS -- I DISCUSSED IT WITH HER. THERE WAS A MEETING WITH A NUMBER OF STAKEHOLDERS TO TALK ABOUT THE RULES THAT WE WERE GOING TO APPLY TO MONITOR QC PERFORMANCE OVER TIME. THEY'RE CALLED WESTGARD RULES. THIS DISCUSSION ALSO INCLUDED THE DISCUSSION OF THE HIGH FAILURE RATE OF THE EDISONS.
MR. BOSTIC: AND HOW DID THIS MEETING COME TO BE, IF YOU REMEMBER?
ADAM ROSENDORFF: I THINK THAT I ASKED THAT A MEETING BE CONVENED. I DON'T RECOLLECT 100 PERCENT, YEAH.
MR. BOSTIC: AND DO YOU RECALL WHO WAS PRESENT AT THAT MEETING?
ADAM ROSENDORFF: MEMBERS OF THE CLIA LAB, HODA ALAMDAR, DANIEL YOUNG, MYSELF, ELIZABETH. SUNNY WAS NOT PRESENT.
MR. BOSTIC: YOU MENTIONED EARLIER THAT YOU REPORTED TO SUNNY BALWANI OFFICIALLY; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WHAT WAS YOUR UNDERSTANDING AS TO WHY MS. HOLMES WAS PRESENT AT THIS MEETING AND MR. BALWANI WAS NOT, IF YOU DID HAVE AN UNDERSTANDING?
ADAM ROSENDORFF: I DID NOT KNOW. I WAS NOT PRIVY TO HOW THEY DIVIDED THEIR DUTIES.
MR. BOSTIC: YOU SAID THAT THAT MEETING INCLUDED A DISCUSSION OF QC PERFORMANCE; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS DISCUSSED IN TERMS OF QC PERFORMANCE IF YOU REMEMBER?
ADAM ROSENDORFF: IT WAS, IT WAS BROUGHT UP AS A PROBLEM. THERE WAS NO RESOLUTION OF IT AT THAT MEETING. THE REMAINDER OF THE MEETING WAS DISCUSSING HOW TO MONITOR QC PERFORMANCE OVER TIME. AND I WOULD JUST ADD TO THAT, WHAT KIND OF ALERTS WOULD HAPPEN ON A -- WOULD NEED TO HAPPEN ON A DAILY BASIS TO ALERT ONE TO A QC PROBLEM.
MR. BOSTIC: AND LET'S LOOK NOW AT EXHIBIT 2188, PLEASE, IN YOUR BINDER. DO YOU SEE THAT EXHIBIT IN FRONT OF YOU?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IS THIS AN EMAIL CHAIN THAT INCLUDES MESSAGES BETWEEN YOURSELF, MS. HOLMES, AND SUNNY BALWANI?
ADAM ROSENDORFF: 2188, SIR?
MR. BOSTIC: 2188?
ADAM ROSENDORFF: I SEE THE FIRST EMAIL IS FROM SUNNY TO MYSELF, THE NEXT EMAIL IS FROM MYSELF TO SUNNY, AND THE THIRD EMAIL IS FROM SUNNY TO MYSELF -- OH, AND THE NEXT EMAIL IS FROM ME TO SUNNY AND ELIZABETH, THE NEXT EMAIL IS FROM ME TO SUNNY AND ELIZABETH.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT OFFERS EXHIBIT 2188 INTO EVIDENCE.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 2188 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: IF WE CAN START ON PAGE 2, PLEASE, AND ZOOM IN ON THE BOTTOM HALF OF THE PAGE.
MR. BOSTIC: DR. ROSENDORFF, ARE YOU LOOKING AT AN EMAIL THAT YOU SENT TO ELIZABETH HOLMES AND SUNNY BALWANI ON NOVEMBER 3RD, 2014?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: OKAY. DO YOU RECALL SENDING THIS EMAIL ON THE GENERAL TOPIC?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS THIS EMAIL ABOUT?
ADAM ROSENDORFF: THIS WAS ABOUT ME DIRECTING THE LABORATORY TO SHOW REFERENCE RANGES IN THE LABORATORY REPORT THAT ARE SPECIFIC TO THE SAMPLE TYPE THAT WOULD BE EITHER THE VENOUS DRAW OR A FINGERSTICK DRAW, AND THE METHOD EMPLOYED, EITHER A PREDICATE METHOD OR A THERANOS METHOD. AND IN LINE ITEMS 1 THROUGH 3 I LIST THE DIFFERENT SAMPLE TYPES AND THE DIFFERENT TESTS.
MR. BOSTIC: AND IN THE CONTEXT OF LABORATORY TESTING AT THERANOS, WHAT WAS A REFERENCE RANGE?
ADAM ROSENDORFF: A REFERENCE -- DO YOU WANT ME TO DEFINE WHAT A REFERENCE RANGE IS?
MR. BOSTIC: YES. WHAT DOES REFERENCE RANGE MEAN IN THIS EMAIL?
ADAM ROSENDORFF: AH. REFERENCE RANGE IS THE RANGE OF VALUES IN A NORMAL POPULATION. IF YOU'RE ABOVE OR BELOW THE REFERENCE RANGE, THAT INDICATES AN ABNORMAL RESULT.
MR. BOSTIC: AND WHAT WERE YOU SUGGESTING IN TERMS OF REFERENCE RANGES AT THERANOS IN THIS EMAIL?
ADAM ROSENDORFF: I WAS SUGGESTING DIFFERENT REFERENCE RANGES THAT WOULD BE SPECIFIC TO THE SAMPLE TYPE AND TO THE METHOD BEING USED.
MR. BOSTIC: WHY DID YOU MAKE THAT SUGGESTION AT THIS TIME IN NOVEMBER 2014?
ADAM ROSENDORFF: BASED ON MY READING AND CLOSE EXAMINATION OF THE DATA THAT WAS COMING OUT OF THE LAB, I DETERMINED THAT NORMAL VALUES WERE LIKELY TO BE DIFFERENT BETWEEN CAPILLARY AND VENOUS BLOOD, AND ALSO THE COLLECTION METHOD WAS IMPACTING THE REFERENCE RANGE, SO BLOOD THAT WAS COLLECTED BY FINGERSTICK WOULD HAVE A DIFFERENT REFERENCE RANGE FROM BLOOD COLLECTED FOR A VACUTAINER.
MR. BOSTIC: YOU SENT THIS REQUEST ONLY TO ELIZABETH HOLMES AND SUNNY BALWANI; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WHY DID YOU DECIDE TO SEND IT TO THOSE TWO INDIVIDUALS?
ADAM ROSENDORFF: I HAD ALREADY DISCUSSED IT WITH DANIEL YOUNG AND HIS OPINION WAS THAT WE SHOULD HAVE ONE REFERENCE RANGE FOR VENOUS BLOOD AND CAPILLARY BLOOD.
MR. BOSTIC: SO IN ESSENCE WERE YOU GOING OVER HIS HEAD HERE?
ADAM ROSENDORFF: I WAS ESCALATING IT.
MR. BOSTIC: WHAT REACTION DID YOU GET FROM MR. BALWANI AND MS. HOLMES WHEN IT CAME TO THE SUGGESTION?
ADAM ROSENDORFF: I REMEMBER TALKING TO ELIZABETH ABOUT IT. SHE DID NOT HAVE A CLEAR POSITION ON IT. I DON'T RECALL -- SO IN TERMS OF PRACTICE NUMBER 2, WHEN I SAY WE SHOULD DISCONTINUE THIS PRACTICE OF ALIQUOTING VENOUS BLOOD INTO NANOTAINERS OR USING VENOUS BLOOD ON THE THERANOS TESTS, HE WAS STRONGLY OPPOSED TO THAT.
MR. BOSTIC: I'LL DIRECT YOU TO PAGE 1 OF THE EXHIBIT, PLEASE. MS. HOLLIMAN, IF WE CAN ZOOM IN ON THE TOP HALF OF THAT PAGE. DR. ROSENDORFF, DO YOU SEE AT THE BOTTOM OF THAT BOX AN EMAIL FROM YOU TO MR. BALWANI ON NOVEMBER 4TH?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU SAY, "FINALLY (AND THERE IS OBJECTIVE DATA ON THIS), THE RATE OF QC FAILURE IS LOWER ON PREDICATE DEVICES THAN IT IS ON EDISONS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN WHAT THAT MEANS, WHAT YOU'RE CONVEYING TO SUNNY?
ADAM ROSENDORFF: THIS IS IN CONNECTION WITH MY CONCERN ABOUT THE HIGH RATE OF QC FAILURE ON THE THERANOS DEVICES, AND I'M TELLING HIM THAT THE QC FAILURE RATE IS LOWER ON THE FDA APPROVED PREDICATE DEVICES THAN IT IS ON THE EDISONS.
MR. BOSTIC: BY "PREDICATE DEVICES," DO YOU MEAN THE NON-THERANOS MANUFACTURED DEVICES?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WHEN YOU SAY "PREDICATE DEVICES," IS THAT SYNONYMOUS WITH FDA APPROVED DEVICES?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND IS THIS WHAT WE WERE DISCUSSING A MOMENT AGO, YOUR COMPARISON OF THE QC FAILURE RATES FOR THE EDISONS COMPARED TO THE NON-THERANOS DEVICES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE REST OF YOUR EMAIL SAYS, "AS IS THE THROUGHPUT OF PREDICATE DEVICES." WHAT DID YOU MEAN BY THAT?
ADAM ROSENDORFF: WHAT I INTENDED TO SAY WAS THAT THE THROUGHPUT, OR HOW MANY SAMPLES YOU CAN RUN IN A GIVEN PERIOD OF TIME, IS HIGHER ON THE PREDICATE DEVICES THAN ON THE EDISONS.
MR. BOSTIC: AND THE PREDICATE DEVICES COULD HANDLE MORE SAMPLES OVER A PERIOD OF TIME?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: MR. BALWANI RESPONDS TO YOU IN THE EMAIL THAT IS ALSO ON THE SCREEN. HE SAYS, "ADAM. THIS IS NOT THE CASE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS MR. BALWANI'S BACKGROUND?
ADAM ROSENDORFF: AS I UNDERSTAND IT, MR. BALWANI HAD A BACKGROUND IN SOFTWARE AND PROGRAMMING. HE ALSO AT ONE POINT WAS ENROLLED IN AN MBA PROGRAM AT BERKELEY.
MR. BOSTIC: TO YOUR KNOWLEDGE, DID HE HAVE ANY MEDICAL OR BIOLOGICAL EDUCATION?
ADAM ROSENDORFF: NO. NONE.
MR. BOSTIC: HE GOES ON TO SAY IN HIS EMAIL, "WHEN A DEVICE FAILS, WE ALWAYS TAKE THE RIGHT CORRECTIVE ACTION AND MAKE SURE IT DOESN'T IMPACT THE QUALITY OF RESULTS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID YOU AGREE AT THIS TIME THAT TAKING CORRECTIVE ACTION WOULD PROVIDE A COMPLETE PROTECTION AGAINST INACCURATE RESULTS GOING OUT THE DOOR?
ADAM ROSENDORFF: NO, IT WOULD NOT GUARANTEE AN ACCURATE RESULT.
MR. BOSTIC: OKAY. WE CAN PUT THAT EXHIBIT ASIDE. THANK YOU. I'D LIKE TO CIRCLE BACK ON A COUPLE OF TOPICS THAT WE DISCUSSED BEFORE THE BREAK. FIRST, THERE WAS SOME DISCUSSION OF THE CTN. DO YOU REMEMBER THAT?
ADAM ROSENDORFF: WHICH EMAIL ARE YOU REFERRING TO?
MR. BOSTIC: I'M NOT REFERRING TO A SPECIFIC EXHIBIT AT THIS TIME. I'M ASKING IF YOU REMEMBER OUR DISCUSSION ABOUT THE CTN.
ADAM ROSENDORFF: OUR DISCUSSION?
MR. BOSTIC: CORRECT.
ADAM ROSENDORFF: YES. YES.
MR. BOSTIC: CAN YOU HELP US UNDERSTAND HOW THE CTN FIT INTO THE WORKFLOW OF ANALYZING A SAMPLE ON AN EDISON?
ADAM ROSENDORFF: SURE. A PHLEBOTOMIST AT THE COLLECTION SITE, TYPICALLY THE WALGREENS, MOST OF THEM ARE IN ARIZONA, THE PHLEBOTOMIST WOULD WARM A PATIENT'S FINGER, PRICK IT WITH A LANCET UNTIL A DROP OF BLOOD APPEARED, AND THEN OPEN UP A CTN -- THAT'S THE CAPILLARY TUBE NANOTAINER -- AND THEN THE CTN, THE CAPILLARY TUBE WOULD MAKE CONTACT WITH THAT BLOOD, AND THE BLOOD WOULD ENTER THE CAPILLARIES. ONCE THE BLOOD ENTERS THOSE CAPILLARIES, THE VACUUM WOULD APPLY AND THE BLOOD WOULD SHOOT INTO THE NANOTAINER. THERE ARE TWO CHAMBERS IN THE NANOTAINER. ALSO, IF A DROP OF BLOOD DID NOT APPEAR AFTER PRICKING, THE PHLEBOTOMIST WOULD OFTEN MILK THE FINGER OR APPLY PRESSURE TO IT TO MAKE THAT DROP OF BLOOD APPEAR.
MR. BOSTIC: SO AT THE END OF THE PROCESS THAT YOU JUST DESCRIBED, THE BLOOD SAMPLE HAS BEEN MOVED THROUGH THE NANOTAINER THROUGH THE CTN?
ADAM ROSENDORFF: THROUGH THE CAPILLARY TUBE.
MR. BOSTIC: OKAY. WHAT HAPPENED NEXT TO THAT BLOOD SAMPLE IF IT WAS GOING TO BE RUN ON AN EDISON?
ADAM ROSENDORFF: THE CTN IS TRANSPORTED TO THE LABORATORY REFRIGERATED IN AN ICE PACK. THOSE CTN'S WOULD BE SPUN DOWN AND THAT WOULD SEPARATE THE RED BLOOD CELLS FROM THE NONCELLULAR PART OF THE BLOOD.
MR. BOSTIC: IS THAT SPUN DOWN IN A CENTRIFUGE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: GO AHEAD.
ADAM ROSENDORFF: SO YOU WOULD HAVE THE CELLULAR PORTION AT THE BOTTOM AND YOU WOULD HAVE EITHER PLASMA OR SERUM AT THE TOP DEPENDING ON WHICH ANTICOAGULANT WAS USED IN THE COLLECTION DEVICE.
MR. BOSTIC: AND WHAT HAPPENED NEXT IN THE PROCESS OF HEADING TOWARDS THE EDISON DEVICE?
ADAM ROSENDORFF: THAT CLEAR LIQUID, THE SERUM OR PLASMA, WOULD BE DRAWN OUT OF THE NANOTAINER AND PUT ONTO A PLATE, NINE 6 VOLT PLATES. IT WOULD THEN BE DILUTED WITH EITHER SALINE OR WATER.
MR. BOSTIC: WHAT CAME AFTER THAT? NOW YOU HAVE A DILUTED SAMPLE; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHERE DOES IT GO NEXT?
ADAM ROSENDORFF: THAT SAMPLE IS NOW READY TO EITHER GO ONTO AN EDISON OR A MODIFIED ADVIA DEVICE.
MR. BOSTIC: SO YOU MENTIONED THE CTN EARLIER. YOU ALSO MENTIONED SOMETHING CALLED A VACUTAINER; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HOW DOES THE VACUTAINER COMPARE TO THE CTN?
ADAM ROSENDORFF: VACUTAINERS ARE ABLE TO DRAW A MUCH HIGHER VOLUME OF BLOOD THAN A CTN. A CTN CAN DRAW ABOUT 60 MICROLITERS OF WHOLE BLOOD, SO A DROP OR TWO. VACUTAINERS ARE DESIGNED TO COLLECT ANYWHERE FROM 8 TO 16 MILS OF WHOLE BLOOD.
MR. BOSTIC: AT THERANOS, WAS ONE TYPICALLY USED WITH A FINGERSTICK AND THE OTHER TYPICALLY USED WITH A VEIN DRAW?
ADAM ROSENDORFF: YES. VENOUS DRAWS WOULD EXCLUSIVELY USE A VACUTAINER, AND FINGERSTICK DRAWS WOULD USE THE CTN.
MR. BOSTIC: AND GENERALLY SPEAKING, WHAT EQUIPMENT WOULD BE USED TO ANALYZE VEIN DRAW SAMPLES THAT WERE DRAWN INTO A VACUTAINER?
ADAM ROSENDORFF: THE FDA APPROVED PREDICATE INSTRUMENTS WOULD BE USED TO ANALYZE THE VENOUS BLOOD THAT IS DRAWN INTO A VACUTAINER.
MR. BOSTIC: AND THOSE DEVICES CONTAINED NO THERANOS MODIFICATIONS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHAT DEVICES IN CONTRAST WOULD BE USED TO RUN SAMPLES DRAWN FROM A FINGERSTICK USING THE NANOTAINER?
ADAM ROSENDORFF: EITHER THE EDISON DEVICE OR THE MODIFIED ADVIA, IN OTHER WORDS, THE THERANOS LABORATORY DEVELOPED TEST. THERE WAS ALSO A THIRD CATEGORY OF COMPLETE BLOOD COUNTS USING WHOLE BLOOD. THAT WOULD BE RUN USING A FLOW CYTOMETER.
MR. BOSTIC: AND WAS THE FLOW CYTOMETER A THERANOS DESIGNED AND MANUFACTURED DEVICE?
MR. BOSTIC: WHEN YOU TESTIFIED EARLIER ABOUT THE TESTING THAT HAD HAPPENED AT SAFEWAY PRIOR TO THE BROADER LAUNCH, DO YOU RECALL THAT TESTIMONY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT DEVICES AND METHODS WERE USED TO CONDUCT THAT TESTING BASED ON YOUR RECOLLECTION?
ADAM ROSENDORFF: VENOUS BLOOD IN VACUTAINERS ON PREDICATE FDA APPROVED INSTRUMENTS.
MR. BOSTIC: FOLLOWING THE COMMERCIAL LAUNCH, CAN YOU HELP US UNDERSTAND THE ROUGH BREAKDOWN OF HOW MANY ASSAYS COULD BE RUN ON THE EDISON VERSUS HOW MANY COULD BE RUN ON THE MODIFIED THIRD PARTY DEVICES VERSUS HOW MANY ON THE UNMODIFIED? AGAIN, JUST ROUGHLY SPEAKING IN TERMS OF PROPORTIONS.
ADAM ROSENDORFF: THIS IS APPROXIMATE. I REMEMBER FOUR TO FIVE IMMUNOASSAYS THAT COULD BE RUN ON THE EDISON, AND ABOUT 20 GENERAL CHEMISTRY TESTS THAT COULD BE RUN ON THE MODIFIED ADVIA. YOU'RE ALSO ASKING HOW MANY COULD BE RUN ON THE PREDICATE DEVICES?
MR. BOSTIC: CORRECT.
ADAM ROSENDORFF: ABOUT 100 GENERAL CHEMISTRY TEST ON THE PREDICATE DEVICE, MORE OR LESS, AND DOZENS ON THE IMMULITES.
MR. BOSTIC: AND DID THOSE NUMBERS CHANGE SOMEWHAT OVER TIME THROUGHOUT YOUR TIME AT THE COMPANY?
ADAM ROSENDORFF: YES. THE COMPANY INTRODUCED MORE AND MORE IMMUNOASSAY TESTS ON THE EDISON AND ALSO EXPANDED THE GENERAL CHEMISTRY MENU.
MR. BOSTIC: AND WAS THAT THE COMPANY'S GOAL AT THE TIME, TO GET AS MANY TESTS ON THE EDISON AS POSSIBLE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID THAT REMAIN THE COMPANY'S GOAL THROUGHOUT YOUR TIME THERE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S SHIFT GEARS. AS LAB DIRECTOR, DID YOU HAVE A ROLE AT THERANOS IN RESPONDING TO COMPLAINTS OR QUESTIONS ABOUT TEST RESULTS?
ADAM ROSENDORFF: I DID.
MR. BOSTIC: AND HOW DID YOU FIT INTO THAT PROCESS?
ADAM ROSENDORFF: PATIENT COMPLAINTS OR PHYSICIAN COMPLAINTS WOULD BE REFERRED TO ME EITHER FROM A CUSTOMER SERVICE EMPLOYEE, OR LATER CHRISTIAN HOLMES, ELIZABETH'S BROTHER, WAS PUT IN THE ROLE OF A LIAISON BETWEEN MYSELF AND THE PHYSICIANS.
MR. BOSTIC: AND DO YOU HAVE AN UNDERSTANDING OF WHO PLACED CHRISTIAN HOLMES IN THAT ROLE?
ADAM ROSENDORFF: I DON'T KNOW.
MR. BOSTIC: YOU MENTIONED THAT CHRISTIAN HOLMES WAS RELATED TO ELIZABETH HOLMES; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WAS CHRISTIAN HOLMES A MEDICAL DOCTOR?
MR. BOSTIC: DID HE HAVE ANY KIND OF SCIENTIFIC OR TECHNICAL ROLE IN THE LAB?
ADAM ROSENDORFF: NO. AT FIRST HE WAS INVOLVED IN THE ROLLOUT OF TESTING SERVICES IN ARIZONA, AND THEN HE CAME TO PLAY THIS LIAISON ROLE.
MR. BOSTIC: HOW DID THAT ACTUALLY FUNCTION IN PRACTICE? HOW DID HE AND YOU INTERACT WHEN IT CAME TO RESPONDING TO CUSTOMER COMPLAINTS?
ADAM ROSENDORFF: CHRISTIAN WOULD EMAIL ME COMPLAINTS THAT HE -- HE WOULD HIMSELF, OR THEY WOULD BE FORWARDED COMPLAINTS FROM PHYSICIANS.
MR. BOSTIC: AND WAS THAT HIS SOLE FUNCTION, TO FORWARD COMPLAINTS TO YOU?
ADAM ROSENDORFF: NO. HE WOULD ASK ME -- HE WOULD CHECK IF I HAD SPOKEN TO THE PHYSICIANS. HE WOULD DISCUSS THE MESSAGING WITH ME.
MR. BOSTIC: AND WHEN YOU SAY DISCUSS THE MESSAGING WITH YOU, WHAT DOES THAT MEAN?
ADAM ROSENDORFF: SO THE COMPANY AND CHRISTIAN'S PREFERENCE WAS THAT IF THERE WAS A SUSPICIOUS RESULT, THAT THERE WOULD BE SOME KIND OF PATIENT FACTOR THAT WOULD EXPLAIN IT, EITHER THE PATIENT WAS ON A CERTAIN MEDICATION AND I WAS OFTEN CALLED UPON TO TRY TO COME UP WITH REASONS OTHER THAN TEST PERFORMANCE THAT WOULD ACCOUNT FOR AN ANOMALOUS RESULT OR TO DEFEND THE RELIABILITY OF THE THERANOS TEST.
MR. BOSTIC: UNDERSTOOD. THANK YOU. WHEN YOU WERE AT THE UNIVERSITY OF PITTSBURGH, YOU WERE ALSO LAB DIRECTOR; CORRECT?
ADAM ROSENDORFF: I WAS FUNCTIONING AS THE LAB DIRECTOR. I WAS NOT THE LAB DIRECTOR OF RECORD. THAT WAS MIGUEL REYES. HE WAS ON THE CMS CERTIFICATE.
MR. BOSTIC: IN THE ROLE THAT YOU DID OCCUPY AT THE UNIVERSITY OF PITTSBURGH, DID YOU ALSO FULFILL THAT FUNCTION OF TALKING TO DOCTORS, FOR EXAMPLE, ABOUT INDIVIDUAL TEST RESULTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HOW WOULD YOU COMPARE THE EXPERIENCE OF FULFILLING THAT ROLE AT THE UNIVERSITY OF PITTSBURGH VERSUS HOW IT WORKED AT THERANOS?
ADAM ROSENDORFF: I NEVER FELT A CONFLICT BETWEEN MY PROFESSIONAL ETHICS AND MY DUTY TO TALK TO THE PHYSICIANS AT THE UNIVERSITY OF PITTSBURGH. MANY OF THE DISCUSSIONS WERE ABOUT WHAT METHOD SHOULD BE CHOSEN WITH THE ENDOCRINOLOGISTS, WHETHER THAT METHOD WAS SENSITIVE ENOUGH TO DETECT VERY LOW LEVELS OF HORMONES, FOR INSTANCE, IN CHILDREN. IT WAS A CHILDREN'S HOSPITAL. AT THERANOS I FELT PRESSURED TO DEFEND THE COMPANY'S RESULTS TO PHYSICIANS.
MR. BOSTIC: WAS THERE ANYONE IN THE CHRISTIAN HOLMES POSITION, THE EQUIVALENT TO THAT, WHEN YOU WERE AT UNIVERSITY OF PITTSBURGH?
MR. BOSTIC: HOW ABOUT WHEN IT CAME TO THE FREQUENCY OF PROBLEMS? WERE QUESTIONS ABOUT TEST RESULTS MORE FREQUENT AT THERANOS THAN AT THE UNIVERSITY OF PITTSBURGH?
ADAM ROSENDORFF: MUCH MORE FREQUENT AT THERANOS.
MR. BOSTIC: LET'S LOOK AT SOME EXAMPLES. I'LL ASK YOU TO TURN TO EXHIBIT 846 IN YOUR BINDER, PLEASE. YOUR HONOR, THE GOVERNMENT IS GOING TO MOVE THIS INTO EVIDENCE. I UNDERSTAND IT'S BEEN STIPULATED TO.
MR. BOSTIC: THIS IS 4836.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4836 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM OCTOBER 2013 WITH A SUBJECT LINE HCG PRECISION?
ADAM ROSENDORFF: YES. YES.
MR. BOSTIC: FIRST OF ALL, WHAT IS HCG?
ADAM ROSENDORFF: HUMAN CHORIONIC GONADOTROPIN. I KNOW THAT'S GOING TO DRIVE THE STENOGRAPHER CRAZY.
MR. BOSTIC: WE'LL CALL IT HCG FROM NOW ON.
ADAM ROSENDORFF: OKAY.
MR. BOSTIC: HOW IS THE HCG TEST USED BASED ON YOUR EXPERIENCE AS A LAB DIRECTOR?
ADAM ROSENDORFF: THE HCG TEST IS MOST COMMONLY USED TO DETECT PREGNANCY, WHETHER A WOMEN IS PREGNANT OR NOT, AND IT'S ALSO USED TO DETECT WHETHER A PREGNANCY IS PROGRESSING NORMALLY.
MR. BOSTIC: I'LL ASK YOU TO LOOK AT PAGE 6 IN THIS EXHIBIT, PLEASE. MS. HOLLIMAN, LET'S PROJECT THAT. LET'S ZOOM IN ON THE BOTTOM EMAIL MESSAGE THERE. LET'S CAPTURE THE HEADER IF WE CAN. THANK YOU. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM OCTOBER 16TH, 2013, FROM SHARADA SIVARAMAN TO DANIEL YOUNG AND KARTHIK JAYASURYA?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IN THIS EMAIL SHARADA SAYS, "DID YOU HAVE A CHANCE TO GO OVER HCG PRECISION DATA? PLEASE LET ME KNOW WHAT YOU THOUGHT. I AM CONCERNED ABOUT THE PROGRESSIVE JUMP IN SIGNAL THAT WE SAW AND WANTED TO KNOW AHEAD OF TIME IF A REPEAT EXERCISE IS REQUIRED." DO YOU HAVE AN UNDERSTANDING AS TO WHAT THIS WOULD BE REFERRING TO?
ADAM ROSENDORFF: I WAS NOT INVOLVED IN THIS PARTICULAR DISCUSSION. I DO NOT HAVE COMMENT ON IT.
MR. BOSTIC: OKAY. AND YOU'RE ADDED TO THE CHAIN ON PAGE 5. IF WE CAN LOOK AT THAT. MS. HOLLIMAN, IF WE CAN LOOK AT PAGE 5 AND ZOOM IN ON THE BOTTOM MESSAGE ON THAT PAGE. DR. ROSENDORFF, DO YOU SEE YOU'RE NOW INCLUDED ON THIS EMAIL CHAIN?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THERE'S A REFERENCE TO DECISION LEVELS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT DOES DECISION LEVELS MEAN IN THE CONTEXT OF THIS KIND OF TEST?
ADAM ROSENDORFF: A DECISION LEVEL IS A VERY SPECIFIC LEVEL THAT A DOCTOR WOULD LOOK AT TO MAKE A CLINICAL DECISION.
MR. BOSTIC: AND WHY DO DECISION LEVELS NEED TO BE CONSIDERED DURING THIS STAGE OF ASSAY DEVELOPMENT?
ADAM ROSENDORFF: BECAUSE THESE ARE THE CRITICAL LEVELS THAT DOCTORS ARE LOOKING AT. YOU WANT TO MAKE SURE YOUR ACCURACY AND PRECISION ARE VERY TIGHT AROUND THESE DECISION LEVELS. IN OTHER WORDS, IF YOUR HCG IS ABOVE 100,000, YOU'RE IN THE ADVANCE STAGES OF PREGNANCY, AND IT'S NOT A CRITICAL NUMBER FOR THE OBSTETRICIAN. AND 6 IS A CRITICAL NUMBER BECAUSE IT WAS USED AS THE CUTOFF TO SAY, ARE YOU PREGNANT OR NOT?
MR. BOSTIC: I SEE. LET'S LOOK AT PAGE 4 OF THIS EXHIBIT AND ZOOM IN ON THE BOTTOM. THIS IS A MESSAGE FROM YOU IN THIS CHAIN; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND IS THIS WHAT YOU WERE JUST TALKING ABOUT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: YOU SAY, "5 MILLIUNITS PER MILLILITER IS A KEY DECISION LEVEL BECAUSE IT DEFINES PREGNANCY." CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S LOOK AT PAGE 3. SO WE'RE MOVING FORWARD IN TIME IN THIS EMAIL CHAIN. SO LET'S LOOK AT PAGE 3 AND THE BOTTOM EMAIL IN THIS MESSAGE, PLEASE. THIS IS AN EMAIL FROM KARTHIK JAYASURYA TO YOU, DANIEL YOUNG, AND SHARADA SIVARAMAN; CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO WAS KARTHIK JAYASURYA AT THERANOS?
ADAM ROSENDORFF: HE WAS A SCIENTIST. I DIDN'T FULLY UNDERSTAND THE RANGE OF ROLES.
MR. BOSTIC: AND IN HIS EMAIL HE THANKS YOU FOR PROVIDING THE INFORMATION THAT YOU'VE PROVIDED AND IT SAYS, "SHARADA, THE METHOD COMPARISON IS FAILING FOR THE DECISION LEVEL 50 MILLIUNITS PER MILLILITER SINCE THE TAE EQUALS 15 PERCENT AND PRECISION ITSELF IS 21 PERCENT AT THAT GIVEN CONCENTRATION, SO WE DON'T HAVE ANY BUDGET FOR BIAS." DO YOU HAVE AN UNDERSTANDING AS TO WHAT THIS WAS REFERRING TO?
ADAM ROSENDORFF: YES. THE TMS ALLOWED -- TOTAL ALLOWABLE ERROR FOR THIS ASSAY OR ANALYTE IS 15 PERCENT. AS I SAID, THE TAE IS THE SUM OF PRECISION AND ACCURACY. THE PRECISION WAS ALREADY AT 21 PERCENT, WHICH IS GREATER THAN 15 PERCENT, SO THERE'S NO ALLOWANCE THERE FOR ANY BIAS. I'LL STOP THERE.
MR. BOSTIC: I WAS GOING TO ASK, IS THIS ANOTHER ONE OF THOSE SITUATIONS WHERE A HIGH PRECISION PERCENTAGE IS AN UNFAVORABLE THING THAT YOU DON'T WANT TO SEE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S LOOK AT THE TOP PART OF THIS MESSAGE, PLEASE, THE TOP PART OF PAGE 3. THERE'S AN EMAIL THERE TO YOU OCTOBER 30TH, 2013; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND KARTHIK WRITES, "HI ADAM, IS THERE A WAY WE CAN RELAX THE TAE CRITERIA AT THAT 50 CONCENTRATION. CURRENTLY, OUR PRECISION STANDS AT 23 PERCENT WHICH IS MUCH MORE THAN TAE, 15 PERCENT." DID I READ THAT CORRECTLY?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND LET'S LOOK AT YOUR RESPONSE ON THE PRECEDING PAGE, SO IF WE GO TO PAGE 2. LET'S ZOOM IN ON THE TEXT OF THAT EMAIL. I'LL DRAW YOUR ATTENTION TO THE LAST SENTENCE OF THE FIRST PARAGRAPH OF YOUR MESSAGE. YOU SAY, "MY CONCERN WITH RELAXING THE TAE AROUND OR NEAR A DECISION POINT IS MAKING THE WRONG CALL FOR A PATIENT." CAN YOU EXPLAIN WHAT YOU MEANT BY THAT?
ADAM ROSENDORFF: YES. IF THE TAE WAS RELAXED TO A HIGHER PERCENTAGE, THIS WOULD ALLOW OUR ASSAY TO OPERATE WITH INCREASED BIAS AND INCREASED IMPRECISION OR A HIGHER CV. IT WOULD RESULT IN A LESS RELIABLE CALL FOR THE PATIENT.
MR. BOSTIC: OKAY. LET'S GO TO PAGE 1 OF THIS EMAIL NOW, SO PAGE 1 OF EXHIBIT 4836. ZOOM IN ON THE BOTTOM MESSAGE, PLEASE. DR. ROSENDORFF, YOU'RE NO LONGER ON THIS EMAIL CHAIN AT THIS POINT; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WE'RE LOOKING AT AN EMAIL FROM SHARADA TO SUNNY BALWANI; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: SHE SAYS, "HI SUNNY, PLEASE SEE BELOW. THE REPEAT EXERCISE OF ENTIRE PRECISION WAS COMPLETED ON TUESDAY, AND THE DATA WAS SENT OUT TO DANIEL AND KARTHIK. "SHE SAID WE STILL DO NOT PASS AT THE THIRD PRECISION LEVEL WHICH IS 50 MILLIUNITS PER MILLILITER BECAUSE OUR PRECISION AT THE LEVEL OF 23 PERCENT BUT WE ARE ALLOWED TAE OF 15 PERCENT." IS SHE ESSENTIALLY REPORTING THE PROBLEM THAT WE HAVE BEEN LOOKING AT UP TO SUNNY BALWANI?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S ZOOM OUT. AT THE BOTTOM OF THAT SQUARE, DO YOU SEE THAT MR. BALWANI THEN FORWARDED THAT TO DANIEL YOUNG, SAMARTHA ANEKAL, AND ELIZABETH HOLMES?
ADAM ROSENDORFF: YES, I READ THAT.
MR. BOSTIC: AND HE REPORTS TO THEM, WE HAVE RUN THIS, I THINK HE MEANS PRECISION, TWICE NOW. CAN YOU LOOK INTO THIS TO SEE WHAT'S THE ISSUE AND WHY WE ARE MISSING THIS? DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND SO AT THIS POINT THIS ISSUE HAS BEEN ELEVATED ALL OF THE WAY TO THE TOP OF THE COMPANY; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WERE YOU AWARE GENERALLY -- DURING YOUR TIME AT THERANOS, WERE YOU AWARE OF ISSUES CONCERNING THE ACCURACY OF THE HCG TEST?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 4145, PLEASE. AND ONCE YOU GET THERE I'LL ASK YOU IF YOU RECOGNIZE IT. I'LL ASK YOU TO TURN TO PAGE 3 OF THAT EXHIBIT AND LOOK AT THE BOTTOM OF THE EMAIL. DO YOU SEE THE EXHIBIT FROM SOMEONE NAMED AMELIA AGUIRRE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE THE EMAIL IS SENT TO AN EMAIL CLS@THERANOS.COM; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS THAT EMAIL ADDRESS, CLS@THERANOS.COM?
ADAM ROSENDORFF: IT WAS A GROUP EMAIL. THE MEMBERS OF THE EMAIL LIST WERE THE CLINICAL LABORATORY SCIENTISTS WITHIN THE COMPANY.
MR. BOSTIC: AND WHAT WAS THE PURPOSE OF HAVING THAT EMAIL GROUP ADDRESS?
ADAM ROSENDORFF: SO THAT THE CLS'S COULD BE ALERTED TO ISSUES OR PROBLEMS IN THE LAB OR PLANS IN THE LAB AS A GROUP.
MR. BOSTIC: AND WAS THIS EMAIL ADDRESS USED FOR THAT PURPOSE, TO DISSEMINATE IMPORTANT INFORMATION ABOUT THE FUNCTIONING OF THE LAB AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS THERE A DUTY ON PEOPLE WHO USED THAT EMAIL ADDRESS FOR THAT PURPOSE TO BE ACCURATE IN THE INFORMATION THAT THEY WERE REPORTING?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WERE EMAILS THAT WERE SENT ON THESE TOPICS PRESERVED AT THERANOS SO THEY COULD BE REFERENCED BACK IN THE FUTURE?
ADAM ROSENDORFF: YES, THAT WAS MY UNDERSTANDING. I CERTAINLY PRESERVED ALL OF THE EMAILS THAT I WAS PRIVY TO.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT 4145.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4145 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S GO TO PAGE 3 OF THIS EXHIBIT, PLEASE. ZOOM IN ON THE BOTTOM HALF.
MR. BOSTIC: DR. ROSENDORFF, ARE WE NOW LOOKING AT THE EMAIL THAT YOU'VE BEEN REVIEWING?
ADAM ROSENDORFF: YES.
MR. BOSTIC: DO YOU REMEMBER WHO AMELIA AGUIRRE WAS AT THERANOS?
ADAM ROSENDORFF: I THINK SHE WAS CUSTOMER SERVICE.
MR. BOSTIC: HER EMAIL TO THE CLS GROUP SAYS, "PHYSICIAN IS CALLING ABOUT RESULTS FOR HCG. NOTES IN LIS INDICATE HCG RESULTS ARE OORL, DO NOT RELEASE UNTIL FURTHER NOTICE." DO YOU KNOW WHAT OORL STANDS FOR?
ADAM ROSENDORFF: OUT OF REFERENCE RANGE LOW. IN OTHER WORDS, THE RESULT IS BELOW THE CAPACITY OF THE INSTRUMENT TO MEASURE.
MR. BOSTIC: IN OTHER WORDS, IS THAT AN ERROR IN THE TEST?
ADAM ROSENDORFF: THAT'S AN ERROR MESSAGE.
MR. BOSTIC: LET'S LOOK AT PAGE 2 NOW. AND IF WE LOOK AT THE BOTTOM OF THAT PAGE, PLEASE. THERE'S A MESSAGE FROM DANIEL YOUNG TO SUNNY BALWANI ON THAT TOPIC; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND THEN DANIEL SAYS, "ACTUALLY, I JUST TOUCHED BASES WITH CHRISTIAN AND ADAM ON THIS EARLIER." WOULD ADAM BE YOU?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THEN, "I ASKED ADAM TO CALL THE DOCTOR TO ASK ABOUT CLINICAL SITUATION. AND THEN WE WILL BE ABLE TO DECIDE IF WE WANT TO RELEASE THE RESULTS." DID I READ THAT CORRECTLY?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S LOOK AT THE MESSAGE JUST ABOVE THAT ONE. ACTUALLY, LET'S SEE IF WE CAN CAPTURE THE REST OF THE TOP TWO-THIRDS OF THE PAGE. DO YOU SEE THAT SUNNY ASKS DANIEL YOUNG, "I ASSUME THIS WAS RUN ON EDISONS." DO YOU SEE THAT AT THE BOTTOM OF THE PAGE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE RESPONSE READS, AT THE TOP OF THE PAGE, "YES, RUN ON EDISONS."
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS THE HCG TEST RUN ON EDISONS AT THIS TIME?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THAT EMAIL IN RESPONSE TO SUNNY BALWANI ALSO SAYS, "WE SPOKE WITH THE ORDERING PHYSICIAN AND MADE THE DECISION TO COLLECTION ANOTHER SAMPLE FROM THE SUBJECT. WE ARE NOT REPORTING OUT THE VERY LOW RESULT." DO YOU SEE THAT?
ADAM ROSENDORFF: YES. THE TOP OF THIS PAGE IS CUT OFF. CAN YOU REMIND ME WHO THE EMAIL IS BEING SENT BY OR FROM?
MR. BOSTIC: YES. LET'S LOOK AT PAGE 1 OF THIS EXHIBIT AND ZOOM IN ON THE BOTTOM AND WE CAN SEE THE HEADER INFORMATION. DO YOU SEE AT THE BOTTOM OF THE PAGE THAT THIS WAS SENT BY DANIEL YOUNG?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU RECALL TIMES AT THERANOS WHEN HCG RESULTS WERE NOT RELEASED BECAUSE THEY CAME BACK ERRONEOUS OR INVALID?
ADAM ROSENDORFF: I RECALL AN INSTANCE WHERE AN INITIAL HCG MEASUREMENT WAS VERY LOW, SUGGESTING A POSSIBLE MISCARRIAGE, AND THEN REPEAT HCG MEASUREMENT AT THERANOS WAS MUCH HIGHER. THIS WAS VERY ALARMING TO ME THAT YOU COULD GET SUCH DIFFERENT RESULTS.
MR. BOSTIC: I SEE. LET'S STAY ON PAGE 1 OF THIS EXHIBIT AND ZOOM IN ON THE TOP HALF OF THE PAGE, PLEASE. THE TOP TWO MESSAGES. DR. ROSENDORFF, DO YOU SEE A MESSAGE FROM DANIEL YOUNG TO SUNNY BALWANI AT THE BOTTOM OF THE PAGE THAT SAYS, "PHYSICIAN NOTED THAT IT WOULD BE SURPRISING TO SEE THE COUNT DROP SO MUCH, EVEN WITH A MISCARRIAGE. HENCE THE AGREEMENT TO COLLECT ANOTHER SAMPLE"?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND AT THE TOP OF THE PAGE, DO YOU SEE A MESSAGE FROM ELIZABETH HOLMES TO SUNNY BALWANI RESPONDING IN THIS EMAIL CHAIN SAYING, "I'VE DONE MANY MEETINGS ON THIS TODAY"?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU RECALL WHETHER YOU WERE PART OF THOSE MEETINGS THAT MS. HOLMES SAT IN ABOUT THIS HCG ISSUE?
ADAM ROSENDORFF: I WAS NOT IN A MEETING WITH HER. I DO RECALL TALKING TO HER. SHE WOULD CHECK IN WITH ME OCCASIONALLY. SHE SAID, HOW'S IT GOING? AND I SAID I WAS FREAKED OUT. AND SHE SAID, WHY? AND I TOLD HER ABOUT THE HCG ISSUE THAT WE'RE DISCUSSING.
MR. BOSTIC: AND WHAT WAS HER REACTION WHEN YOU TOLD HER THAT YOU WERE FREAKED OUT ABOUT THE HCG ISSUE?
ADAM ROSENDORFF: SHE SAID, DON'T BE FREAKED OUT OR -- YOU KNOW, SHE DIDN'T SEEM ALARMED BY IT.
MR. BOSTIC: WE'RE LOOKING AT AN EMAIL CHAIN THAT DOESN'T INCLUDE YOU. DO YOU BELIEVE YOU SHOULD HAVE BEEN INCLUDED IN DISCUSSIONS ABOUT OUT OF RANGE HCG RESULTS AT THERANOS?
ADAM ROSENDORFF: ABSOLUTELY.
MR. BOSTIC: LET'S LOOK AT 4147. THE GOVERNMENT OFFERS THIS INTO EVIDENCE. I BELIEVE THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE DISPLAYED.
(GOVERNMENT'S EXHIBIT 4147 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: LET'S ZOOM IN ON THE MIDDLE MESSAGE ON THE PAGE THERE. DR. ROSENDORFF, IS THIS AN EMAIL FROM YOU TO CLS ON MAY 30TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CLS, IS THAT THAT SAME GROUP OF LABORATORY STAFF THAT WE WERE JUST TALKING ABOUT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND YOUR MESSAGE IS WRITTEN IN ALL CAPITAL LETTERS; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND THIS IS ALSO MARKED IMPORTANCE HIGH. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS THAT YOUR DECISION TO MARK THIS EMAIL HIGH IMPORTANCE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU WRITE IN YOUR EMAIL TO LABORATORY STAFF, "ALL FURTHER HCG TESTING (CTN OR VACUTAINER) IS TO BE RUN ON THE IMMULITE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHY WERE YOU MAKING THAT DECISION AT THIS TIME IN MAY OF 2014?
ADAM ROSENDORFF: BASED ON THE HIGH CV'S FOR THE EDISON HCG TEST AND THE INCONSISTENT RESULTS WE WERE GETTING ON THE EDISON, I DETERMINED THAT THIS TEST WAS NOT FIT FOR PATIENT CARE.
MR. BOSTIC: AND WHEN YOU SAY "ALL FURTHER HCG TESTING IS TO BE RUN ON THE IMMULITE," REMIND US WHAT THE IMMULITE IS, PLEASE.
ADAM ROSENDORFF: THE IMMULITE IS A SIEMENS MANUFACTURED INSTRUMENT. IT'S FDA APPROVED TO CONDUCT IMMUNOASSAYS, INCLUDING HCG.
MR. BOSTIC: SO, IN OTHER WORDS, YOU WERE DECIDING THAT THE HCG TEST NEEDED TO BE TAKEN OFF OF THE EDISON, OFF THE THERANOS DEVICE AND PUT ON THE THIRD PARTY DEVICE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: NUMBER 2 IN YOUR LIST OF INSTRUCTIONS INSTRUCTS STAFF, "HOLD ALL EDISON CTN RESULTS - DO NOT RELEASE." DO YOU SEE THAT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHY DID YOU FEEL CURRENTLY PENDING RESULTS COULDN'T EVEN GO OUT?
ADAM ROSENDORFF: I WANTED TO MAKE THIS DECISION RETROACTIVE TO RESULTS THAT HAD ALREADY BEEN RUN ON THE EDISONS.
MR. BOSTIC: LET'S ZOOM OUT AND ZOOM IN ON THE TOP PORTION OF THIS EMAIL, PLEASE. DO YOU SEE, DR. ROSENDORFF, AT THE TOP OF THIS PAGE SUNNY BALWANI FORWARDED THIS EMAIL TO ELIZABETH HOLMES ON MAY 31ST, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 4840, PLEASE. I'LL ASK YOU FIRST TO LOOK AT THE BOTTOM OF PAGE 3 ON THAT EXHIBIT AND LET ME KNOW IF YOU SEE AN EMAIL FROM AMELIA AGUIRRE TO INDIVIDUALS, INCLUDING CLS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: IS THIS ANOTHER EMAIL SENT TO THAT GROUP FOR THE PURPOSE OF DISCUSSING PATIENT TEST RESULTS AS WE'VE TALKED ABOUT BEFORE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4840.
MR. WADE: YOUR HONOR, I DON'T HAVE A COPY OF 4840 IN MY BOOK. IF I COULD -- IF COUNSEL HAS A COPY?
JUDGE DAVILA: IT MIGHT BE UNDER 4846.
MR. BOSTIC: I'M HAPPY TO GIVE MY COPY TO DEFENSE COUNSEL, YOUR HONOR.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4840 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S START AT THE BOTTOM OF PAGE 3, THE MIDDLE HALF OF THE PAGE.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM --
COURT CLERK: JUST A MOMENT, YOUR HONOR. IT'S NOT DISPLAYING. IS IT UP?
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM AMELIA AGUIRRE TO INDIVIDUALS AT THERANOS, INCLUDING THAT CLS GROUP?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE TEXT OF THE EMAIL SAYS, "PLEASE SEE IF YOU CAN RUN THIS ASAP. PHYSICIAN HAS CALLED SEVERAL TIMES TODAY LOOKING FOR RESULTS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND ABOVE THAT IS ANOTHER MESSAGE, "WE ALSO HAVE ANOTHER PHYSICIAN LOOKING FOR RESULTS FOR," AND WE'VE REDACTED THE NAME, "VISIT IS FROM JUNE 10TH, 2014, ALSO FOR TEST HCG." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT THE TOP HALF OF PAGE 3, PLEASE. DO YOU SEE THIS EMAIL MESSAGE FROM ROMINA RIENER ON JUNE 12, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND SHE SAYS, "WE RAN THAT SAMPLE YESTERDAY BUT RESULTS CAME OUT INVALID (FAILED RUN). IT IS STILL PENDING A RERUN." WHAT IS YOUR UNDERSTANDING OF WHAT THAT WOULD MEAN?
ADAM ROSENDORFF: THE INSTRUMENT WAS UNABLE TO RETURN A RESULT.
MR. BOSTIC: AND IS THAT BECAUSE OF A -- WELL, WHAT'S YOUR UNDERSTANDING OF WHAT ISSUES COULD LEAD TO THAT OUTCOME?
ADAM ROSENDORFF: IT COULD BE MANY DIFFERENT ISSUES. IT COULD BE A PROBLEM WITH THE CHEMICALS, THE REAGENTS IN THE CARTRIDGE EITHER NOT BEING PRESENT OR NOT BEING MIXED PROPERLY. IT COULD BE A PROBLEM WITH INSTRUMENTATION, WITH DETECTION WITHIN THE INSTRUMENT. THERE ARE A NUMBER OF REASONS WHY IT COULD BE INVALID, YEAH.
MR. BOSTIC: LET'S ZOOM OUT AND LOOK AT PAGE 2, PLEASE, IN THIS EXHIBIT. LET'S ZOOM IN ON THE BOTTOM HALF OF THE PAGE. DO YOU SEE AN EMAIL FROM MAX FOSQUE SENT AT 11:31 A.M. ABOUT THIS ISSUE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THERE'S AN EMAIL BELOW THAT FROM CHRISTIAN HOLMES SAYING, "THIS ONE IS CRITICAL IN CASE YOU GUYS ARE DEALING WITH THIS AT ALL." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND MR. FOSQUE RESPONDS, "I BELIEVE TINA JUST BROUGHT THIS UPSTAIRS, WE CAN RUN NEAT ON THE IMMULITE. TINA CAN U CONFIRM?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: REMIND US WHAT THE UPSTAIRS PORTION OF THE THERANOS LAB CONTAINED.
ADAM ROSENDORFF: THE UPSTAIRS PORTION OF THE LAB CONTAINED FDA APPROVED PREDICATE INSTRUMENTS THAT WERE NOT MODIFIED THAT WERE DESIGNED TO TEST VACUTAINER BLOOD, BLOOD FROM VACUTAINERS, VENOUS BLOOD.
MR. BOSTIC: AROUND THIS TIME IN THE MIDDLE OF 2014, WAS THE DEFAULT TO RUN HCG TESTS ON THE THIRD PARTY DEVICES OR ON THE THERANOS EDISON?
ADAM ROSENDORFF: ON THE EDISON.
MR. BOSTIC: SO IN THIS CASE WE'RE SEEING A CHANGE OF PLANS ESSENTIALLY AND THE SAMPLE IS NOW POSSIBLY GOING TO BE RUN ON THE THIRD PARTY DEVICE INSTEAD?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: THE EMAIL ABOVE THAT FROM TINA LIN SAYS, "I BROUGHT IT UPSTAIRS BUT HODA SAID THEY CAN'T RUN IT? CAN YOU CHECK WHY?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT THE TOP HALF, OR THE VERY TOP PORTION OF PAGE 2, PLEASE. ACTUALLY, LET'S ZOOM OUT AND CAPTURE THE WHOLE TOP HALF OF THE PAGE. DO YOU SEE THAT MESSAGE FROM TINA LIN THAT SAYS, "SO THEY'RE TESTING THE DEAD VOLUME RIGHT NOW. THEY CAN'T GET IT TO WORK YET"?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: AND THEN SHE SAYS, "WE'RE MINUTES AWAY FROM FINDING OUT WHETHER HCG ON EITHER OF THE EDISON DEVICES HAVE PASSED." DO YOU KNOW WHAT THAT WOULD BE A REFERENCE TO?
ADAM ROSENDORFF: I DON'T KNOW SPECIFICALLY. IT WOULD EITHER BE WHETHER THAT SAMPLE HAD PASSED ON THE EDISONS OR WHETHER THE QC HAD PASSED. I CAN'T SAY FOR SURE.
MR. BOSTIC: LET'S GO TO PAGE 1 NOW IN THIS EXHIBIT. LET'S ZOOM IN ON THE BOTTOM PORTION. LET'S GO TO THE BOTTOM TWO OR THREE EMAIL MESSAGES. OKAY. AND DO YOU SEE AT THE BOTTOM THERE, THERE'S A MESSAGE FROM TINA LIN PROVIDING ANOTHER UPDATE HERE SAYING, "LEVEL 2 FOR HCG JUST BARELY FAILED ON BOTH READERS, SORRY. WE'RE TRYING AGAIN."
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: DOES THAT CLARIFY TO YOU WHAT THAT WOULD BE REFERRING TO?
ADAM ROSENDORFF: YES, THAT WOULD BE QC, LEVEL 2.
MR. BOSTIC: AND WOULD THIS BE REFERRING TO THE EDISON?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND THERE'S AN EMAIL ABOVE THAT FROM CHRISTIAN HOLMES TO ELIZABETH HOLMES. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CHRISTIAN WRITES, "JUST FYI - HCG RIGHT NOW CAUSING SOME SERIOUS ISSUES IN PATIENT COMPLAINTS. BEEN SPENDING ALL MORNING TALKING TO DOCS ABOUT JUST HCG AND WILL CONTINUE TO DO SO...IT'S A SENSITIVE ONE OBVIOUSLY B/C OF PEOPLE FINDING OUT IF PREGNANT." IS THAT CORRECT?
ADAM ROSENDORFF: YES, I READ THAT.
MR. BOSTIC: DURING THIS TIME IN MID-JUNE 2014, DO YOU RECALL WHETHER YOU WERE PART OF CONVERSATIONS WITH DOCTORS ABOUT PROBLEMS WITH THERANOS HCG TESTS?
ADAM ROSENDORFF: I WAS NOT.
MR. BOSTIC: LET'S ZOOM OUT AND ZOOM IN ON THE TOP HALF OF THE PAGE, PLEASE. OR LET'S ZOOM IN ON THE MIDDLE PART ACTUALLY. THANK YOU. CHRISTIAN HOLMES FOLLOWS UP ON HIS EMAIL TO ELIZABETH HOLMES SAYING, "SEEMS LIKE WE ALSO HAVE A CAPACITY ISSUE RIGHT NOW WITH EDISONS AT FULL CAPACITY AND VENOUS SAMPLES IN A SERIOUS QUEUE NOT BEING RUN. WENT DOWN THERE AND IT'S A COMPLETE MESS." DO YOU RECALL EXPERIENCING CAPACITY ISSUES WITH TESTING BANDWIDTH AT THERANOS?
ADAM ROSENDORFF: YES, I RECALL CAPACITY ISSUES WITH THE EDISON TESTS.
MR. BOSTIC: AND DID SOME OF THAT COME DOWN TO THE QC FAILURE RATES AND OTHER PROBLEMS THAT WE HAVE BEEN TALKING ABOUT?
ADAM ROSENDORFF: CORRECT. THE EDISONS WERE ALSO PRETTY SLOW BY COMPARISON WITH THE IMMULITE, EVEN IF THEY WERE WORKING PROPERLY.
MR. BOSTIC: AND DID THAT CONTRIBUTE TO A BACKLOG OR SLOWDOWN IN THE LAB?
ADAM ROSENDORFF: YES.
MR. BOSTIC: ALL RIGHT. LET'S ZOOM OUT AND LOOK AT THE TOP MESSAGE IN THIS CHAIN, PLEASE. ACTUALLY, LET'S GO DOWN TO -- LET'S CAPTURE THE WHOLE TOP HALF. PERFECT. THANK YOU. MS. HOLMES THEN RESPONDS TO HER BROTHER AND TO SUNNY BALWANI. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: SHE SAYS, "WE'LL CONNECT IN DETAIL ON THIS AS SOON AS I'M OUT. "SUNNY, THIS IS ALREADY HANDLED - JUST FYI." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CHRISTIAN WRITES BACK ABOUT AN EXPERIENCE THAT HE HAD WHERE A DOCTOR SENT THERANOS THREE PATIENTS AND ALL RESULTS HAVE BEEN OVER FOUR DAYS, THIS BEING THE THIRD PATIENT. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: DO YOU HAVE A RECOLLECTION OF DELAYS THIS LONG DURING YOUR TIME AT THERANOS, RESULTS WAITING AS LONG AS FOUR DAYS?
MR. BOSTIC: AND DO YOU THINK YOU SHOULD HAVE BEEN INVOLVED IN CONVERSATIONS ABOUT THIS DELAY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: CHRISTIAN GOES ON TO REPORT THAT THAT DOCTOR ORIGINALLY SAID HE WON'T SEND US ANYMORE PATIENTS BECAUSE WE HAVE HAD ISSUES WITH ALL THREE PATIENTS. BUT AT THE END OF THE CALL, HE SAID HE WOULD BE WILLING TO EVALUATE THIS FURTHER BASED ON PATIENT NEEDS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID YOU HAVE ANY EXPERIENCES TALKING TO DOCTORS WHO EXPRESSED CONCERNS ABOUT THE VALIDITY OR ACCURACY OF THERANOS HCG RESULTS?
MR. BOSTIC: LET'S LOOK AT EXHIBIT 4222, PLEASE. LET ME KNOW ONCE YOU'RE THERE.
ADAM ROSENDORFF: I SEE IT.
MR. BOSTIC: OKAY. I'LL ASK YOU TO LOOK AT THE FIRST PAGE OF THAT EXHIBIT AT THE TOP. DO YOU SEE AN EMAIL FROM SUNNY BALWANI TO ELIZABETH HOLMES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE THAT THE SUBJECT LINE IS CUSTOMER ISSUE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IF YOU LOOK DOWN ON THAT PAGE, DO YOU SEE THERE'S ADDITIONAL CORRESPONDENCE RELATING TO ANOTHER HCG ISSUE AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4222.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4222 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S START ON PAGE 1 OF THIS EXHIBIT, PLEASE, MS. HOLLIMAN. AND LET'S ZOOM IN ON THE VERY BOTTOM, PLEASE, JUST TO CAPTURE THAT INFORMATION.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE WE'RE ABOUT TO LOOK AT AN EMAIL FROM SOMEONE NAMED ALLISON MARTIN AT IVF PHOENIX SENT TO ERIC NELSON, AND THE SUBJECT LINE IS LABS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THIS WAS SENT ON SEPTEMBER 29TH, 2014; CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S GO TO PAGE 2, PLEASE, MS. HOLLIMAN. LET'S ZOOM IN ON THE TEXT AT THE TOP, PLEASE. DR. ROSENDORFF, IS THIS AN EMAIL FROM A MEDICAL SERVICE PROVIDER TO THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: THE EMAIL READS, "ERIC, THANK YOU SO MUCH FOR DROPPING OFF THE NEW ORDER SHEETS. I AM SORRY I WAS UNAVAILABLE AT THAT TIME. "WE WILL CALL THE SUPPORT LINE, BUT ALSO WANTED TO GIVE YOU A HEADS UP ON WHAT HAPPENED WITH THE LAB. WE SENT A PATIENT OF OURS IN FOR HER 48-HOUR REPEAT ON HER QB HCG." WHAT IS QB HCG?
ADAM ROSENDORFF: I DON'T KNOW WHAT THE Q AND THE B STAND FOR.
MR. BOSTIC: IS HCG REFERENCING THE TEST THAT WE'VE BEEN TALKING ABOUT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: THE MEDICAL SERVICE PROVIDER GOES ON TO REPORT THAT "THE PATIENT'S INITIAL TEST CAME BACK AT 160 (RUN AT A DIFFERENT LAB) AND WHEN WE SENT HER BACK IN FOR HER REPEAT WITH YOUR LAB THE RESULTS CAME BACK AT LESS THAN 7.82." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL GOES ON. "BECAUSE HER TEST CAME BACK NEGATIVE, WE HAD HER DISCONTINUE HER CURRENT MEDICATIONS AND BEGAN GETTING HER READY FOR HER NEXT CYCLE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IT GOES ON. "A FEW WEEKS LATER SHE WENT BACK IN FOR ANOTHER QB HCG AND IT CAME BACK AT OVER 2000. WE BROUGHT HER IN AND I SCANNED HER, AND THERE WAS IN FACT A BABY AND A HEARTBEAT." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL CONTINUES. "OUR CONCERN IS THAT YOUR LAB TOLD US SHE HAD A NEGATIVE PREGNANCY, WE RELAYED THAT TO OUR PATIENT AND CONTINUED OUR PROTOCOL AS SHE WASN'T PREGNANT." DID I READ THAT CORRECTLY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S GO BACK TO PAGE 1 OF THIS EXHIBIT AND ZOOM IN ON THE BOTTOM HALF, PLEASE. DO YOU SEE THAT ERIC NELSON FORWARDS THAT INFORMATION TO MIKE PHEBUS AND KIMBERLY ALFONSO?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU IDENTIFY THOSE INDIVIDUALS AT THERANOS. DID YOU WORK WITH THEM?
ADAM ROSENDORFF: I DID NOT WORK WITH ERIC NELSON OR MIKE PHEBUS. I DID WORK WITH KIMBERLY ALFONSO.
MR. BOSTIC: AND WHAT WAS HER POSITION?
ADAM ROSENDORFF: I BELIEVE SHE WAS A LIAISON WITH THE CLINICAL SITES, THE COLLECTION SITES. I RECOGNIZE THE NAME. I DON'T KNOW FOR SURE WHAT HER ROLE WAS.
MR. BOSTIC: THE EMAIL ABOVE THAT IS FROM MS. ALFONSO TO CHRISTIAN HOLMES AND SUNNY BALWANI; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND SHE WRITES "PLEASE SEE BELOW." SHE SAYS, "STILL NEED INFO ON HCG INQUIRY FROM LAST MONTH TOO (RE: AUGUST 20TH WITH 600,000 RESULT FROM THAT NURSE PRACTITIONER)." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU WERE NOT INCLUDED ON THESE EMAILS; IS THAT CORRECT?
ADAM ROSENDORFF: THAT'S CORRECT.
MR. BOSTIC: AND DO YOU BELIEVE YOU SHOULD HAVE BEEN INCLUDED IN DISCUSSIONS ABOUT HCG RESULTS LIKE THESE?
ADAM ROSENDORFF: YES, ABSOLUTELY.
MR. BOSTIC: LET'S ZOOM IN ON THE TOP PORTION OF PAGE 1, PLEASE, THE TOP TWO MESSAGES. ACTUALLY, THE TOP THREE MESSAGES. DO YOU SEE ON SEPTEMBER 29TH, AT 4:45 P.M., SUNNY BALWANI FORWARDED THIS INFORMATION TO ELIZABETH HOLMES?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: AND MS. HOLMES RESPONDS, "HOW DID THAT HAPPEN?"
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: AND MR. BALWANI RESPONDS, "FINDING OUT." IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK NOW AT EXHIBIT 4228. DO YOU HAVE EXHIBIT 4228 IN FRONT OF YOU?
ADAM ROSENDORFF: YES.
MR. BOSTIC: IS THIS A CONTINUATION OR A DIFFERENT VERSION OF THE SAME EMAIL CHAIN THAT WE WERE LOOKING AT?
ADAM ROSENDORFF: IT APPEARS THAT WAY BASED ON THE DATES.
MR. BOSTIC: OKAY.
ADAM ROSENDORFF: OH, IT IS. IT IS STILL REFERENCING -- THE SUBJECT LINE IS IDENTICAL, IT SAYS FORWARD CUSTOMER ISSUE GM.
MR. BOSTIC: THANK YOU. THE GOVERNMENT MOVES INTO EVIDENCE EXHIBIT 4228.
JUDGE DAVILA: IT IS ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4228 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S LOOK AT THE BOTTOM OF PAGE 2. AND ZOOM IN ON THE VERY BOTTOM MESSAGE.
MR. BOSTIC: DO YOU SEE AN EMAIL FROM MAXIMILIAN FOSQUE TO DANIEL YOUNG, CHINMAY PANGARKAR, SUNNY BALWANI, CHRISTIAN HOLMES ON SEPTEMBER 29TH, 2014?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: AND MR. FOSQUE WRITES, "A DOCTOR'S OFFICE HAS REPORTED A POTENTIAL DISCREPANCY WITH OUR HCG RESULTS." IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S TURN TO PAGE 3. AND LET'S ZOOM IN ON THE TOP, PLEASE. THAT EMAIL GOES ON TO SAY, "ON OR AROUND SEPTEMBER 3RD OR SEPTEMBER 4TH A PATIENT GOT HCG RESULTS FROM ANOTHER LAB 160 MILLIUNITS PER MILLILITER. WITHIN 48 HOURS THE PATIENT CAME TO WALGREENS (VISIT DATE 9/5) AND WE COLLECTED 1 EDTA CTN." THAT MENTION OF COLLECTION IN THE CTN, WHAT DOES THAT SIGNIFY TO YOU ABOUT THE METHOD OF DRAW?
ADAM ROSENDORFF: THAT WOULD BE A FINGERSTICK DRAW FOR RUN ON THE EDISON INSTRUMENT.
MR. BOSTIC: THE EMAIL GOES ON, "WE REPORTED RESULTS OF OORL." REMIND US, WHAT DOES THAT STAND FOR?
ADAM ROSENDORFF: OUT OF RANGE LOW.
MR. BOSTIC: AND IT SAYS, "LESS THAN 7.82 MILLIUNITS PER MILLILITER. DUE TO THIS MEDICATIONS WERE DISCONTINUED. HOWEVER, THE PATIENT RETURNED ON SEPTEMBER 19TH WITH THE SAME TEST ORDERED ALONG WITH PROGESTERONE. WE THEN REPORTED HCG RESULTS OF 2150.01 MILLIUNITS PER MILLILITER (ALIQUOT TO CTN AND RUN ON EDISON.)" DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: IT GOES ON TO SAY, "THE OFFICE IS INQUIRING AS TO WHY THE FIRST RESULT WAS REPORTED AS A NEGATIVE, WHERE IN FACT IT IS LIKELY IT SHOULD HAVE BEEN A POSITIVE VALUE." DID YOU AGREE AT THE TIME WITH THE OFFICE'S CONCLUSION ABOUT THE ACCURACY OF THIS TEST? ACTUALLY, LET ME JUST ASK YOU, THE QUESTION IS, DO YOU AGREE WITH THE OFFICE'S CONCLUSION ABOUT THE ACCURACY OF THESE TESTS?
ADAM ROSENDORFF: YES. YES, I DO.
ADAM ROSENDORFF: OH, I'M SORRY.
JUDGE DAVILA: OVERRULED.
BY MR. BOSTIC:
MR. BOSTIC: SORRY. YOU CAN FINISH YOUR ANSWER, DR. ROSENDORFF.
ADAM ROSENDORFF: I SEE THAT THE RESULTS ON 9/5 WAS LESS THAN 7.8, AND TWO WEEKS LATER ON 9/19 THE RESULT WAS OVER 2000. I CANNOT THINK OF A CLINICAL SCENARIO THAT WOULD EXPLAIN THIS DISCREPANCY.
MR. BOSTIC: LET'S LOOK AT PAGE 1 IN THE TOP HALF OF THE PAGE, PLEASE. DO YOU SEE AT THE BOTTOM OF THAT SELECTION AN EMAIL FROM DANIEL YOUNG?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL IS SENT TO INDIVIDUALS AT THERANOS, INCLUDING SUNNY BALWANI AND CHRISTIAN HOLMES; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL STATES, "BASED ON THE INDIVIDUAL TIP DATE FOR THE FINGERSTICK SAMPLE, THERE WERE 4 TIPS REPORTING OUT OF RANGE LOW AND TWO REPORTING INVALID." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT DOES IT MEAN FOR A TIP TO REPORT INVALID?
ADAM ROSENDORFF: THAT TIP IS UNABLE TO GENERATE A SIGNAL OR REPORT A VALUE.
MR. BOSTIC: DANIEL YOUNG GOES ON TO SAY, "IT IS POSSIBLE THAT A PROCESSING ERROR OCCURRED, BUT WE REALLY DO NOT HAVE DIRECT EVIDENCE OF ANY ERRORS BASED ON THIS DATA. "FROM THE PATIENT HISTORY, GIVEN MEDICATION AND OTHER FACTORS THAT WE DO NOT FULLY KNOW, THERE COULD HAVE BEEN SOME UNUSUAL TRENDS IN THIS ANALYTE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS DANIEL YOUNG A PHYSICIAN?
MR. BOSTIC: WAS DANIEL YOUNG -- DID HE HAVE A POSITION IN THE CLINICAL LAB AT THERANOS?
ADAM ROSENDORFF: DANIEL YOUNG WAS VERY INVOLVED IN THE CLIA LAB AFTER THE TESTS WERE LAUNCHED. HE WOULD OFTEN OFFER HIS OPINION AS TO THE VALIDITY OF THE RESULTS.
MR. BOSTIC: WAS HE A CLS IN THE CLINICAL LAB?
MR. BOSTIC: HOW ABOUT A CLA, IS THAT THE LEVEL BELOW?
ADAM ROSENDORFF: NO, HE WAS NOT.
MR. BOSTIC: DID HE HAVE ANY OFFICIAL TITLE IN CONNECTION WITH THE CLINICAL LAB?
ADAM ROSENDORFF: HIS TITLE AT THE COMPANY WAS VICE PRESIDENT OF THERANOS SYSTEMS.
MR. BOSTIC: LOOKING AT THE VERY TOP OF THE MESSAGE HERE, DO YOU SEE THAT ON SEPTEMBER 30TH, 2014, SUNNY BALWANI FORWARDED ALL OF THIS INFORMATION TO ELIZABETH HOLMES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 1543, PLEASE. LET ME ASK, BEFORE WE MOVE ON TO THAT EXHIBIT, DO YOU RECALL LOOKING AT AN EXHIBIT WHERE YOU DIRECTED THAT NO ADDITIONAL HCG TESTING WAS GOING TO BE PERFORMED ON THE EDISON?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU RECALL WHAT THE OUTCOME WAS OF THAT DECISION?
ADAM ROSENDORFF: I DO NOT.
MR. BOSTIC: WE LOOKED AT SOME EXAMPLES AFTER THAT DATE WHERE HCG WAS STILL RUN ON THE EDISON; IS THAT CORRECT?
ADAM ROSENDORFF: YES. SO MY INITIAL INSTRUCTIONS I BELIEVE WERE IN JUNE OF 2014. I DON'T RECALL EXACTLY THE DATES, I'M SORRY.
MR. BOSTIC: NO PROBLEM. LET'S GO BACK JUST BRIEFLY TO EXHIBIT 4147, PLEASE, WHICH IS IN EVIDENCE.
ADAM ROSENDORFF: I'M SORRY, THAT WAS MAY. GOT IT.
MR. BOSTIC: IS THAT REFRESHING YOUR RECOLLECTION ABOUT WHEN THAT HAD HAPPENED?
ADAM ROSENDORFF: YES.
MR. BOSTIC: BASED ON THE EMAILS THAT WE HAVE LOOKED AT SINCE THAT, DOES IT APPEAR THAT HCG WAS CONTINUED TO BE RUN ON THE EDISON EVEN FOLLOWING THIS DECISION?
ADAM ROSENDORFF: CORRECT, THEY WERE NOT FOLLOWING MY DIRECTIVE.
JUDGE DAVILA: COULD YOU LAY A LITTLE MORE FOUNDATION FOR THAT, PLEASE.
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, ARE YOU AWARE OF INSTANCES FOLLOWING THIS DATE WHERE THERANOS RAN THE HCG TEST ON THE EDISON?
ADAM ROSENDORFF: I WAS NOT AWARE.
MR. BOSTIC: OKAY. ARE YOU AWARE OF THAT FACT TODAY?
ADAM ROSENDORFF: YES, I AM.
MR. BOSTIC: DO YOU HAVE EXHIBIT 1543 IN FRONT OF YOU?
ADAM ROSENDORFF: I HAVE IT NOW.
MR. BOSTIC: I'LL DIRECT YOUR ATTENTION TO PAGE 5 AND LOOKING AT THAT PAGE, I'LL ASK YOU IF YOU RECOGNIZE AN EMAIL FROM YOU DIRECTED TO DANIEL AND SUNNY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU KNOW WHO DANIEL AND SUNNY WOULD BE IN THIS EMAIL?
ADAM ROSENDORFF: DANIEL YOUNG AND SUNNY BALWANI.
MR. BOSTIC: I'LL ASK YOU TO TURN TO PAGE 4. AND DO YOU SEE AT THE BOTTOM OF PAGE 4 MS. HOLMES IS THEN ADDED TO THE EMAIL CHAIN?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 1543.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1543 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S START WITH PAGE 5, PLEASE. LET'S ZOOM OWN IN ON THE EMAIL BEGINNING WITH DANIEL AND SUNNY.
MR. BOSTIC: DO YOU SEE THE EMAIL ON FEBRUARY 19TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IT SAYS, "WE HAVE BEEN GETTING A SPATE OF LOW HDL VALUES." IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND CAN YOU EXPLAIN WHAT WAS HAPPENING AT THIS TIME AND WHY YOU SENT THIS EMAIL?
ADAM ROSENDORFF: WE WERE GETTING PHYSICIAN QUERIES AND COMPLAINTS ABOUT LOW HDL VALUES AND ABOUT THE CHOLESTEROL RESULTS IN GENERAL.
MR. BOSTIC: AND WHAT IS HDL?
ADAM ROSENDORFF: HIGH DENSITY LIPOPROTEIN.
MR. BOSTIC: AND WHAT IS THAT TEST ABOUT?
ADAM ROSENDORFF: IT IS IMPORTANT FOR CARDIO VASCULAR HEALTH.
MR. BOSTIC: AND THE REPORTS THAT YOU WERE GETTING FROM DOCTORS ABOUT HDL VALUES COMING OUT OF THERANOS, DID THEY CAUSE YOU CONCERN AT THE TIME?
ADAM ROSENDORFF: YES, THEY DID.
MR. BOSTIC: AND WHY IS THAT?
ADAM ROSENDORFF: AS MENTIONED IN THE EMAIL THESE ARE PATIENTS AND THE GENERAL POPULATION, AND THEY'RE ALL SHOWING RESULTS IN THE FIFTH PERCENTILE OR LESS. ANOTHER 95 PERCENT OF FOLKS HAVE HDL'S THAT ARE HIGHER. STATISTICALLY THIS DOES NOT SEEM LIKELY TO ME IN THE SPAN OF FOUR DAYS FROM 2-14 TO 2-18 THAT WE WOULD BE GETTING THE SPATE OF LOW HDL'S.
MR. BOSTIC: AND WHAT DID THAT CAUSE YOU TO SUSPECT?
ADAM ROSENDORFF: A PROBLEM WITH THE ASSAY.
MR. BOSTIC: AND, IN FACT, YOU WRITE IN YOUR EMAIL, "WE HAVE BEEN GETTING A SPATE OF LOW HDL VALUES. I SUSPECT THAT OUR HDL ASSAY HAS FAILED AND I DO NOT WANT TO REPORT OUT THIS RESULT UNTIL WE FIX IT." DO YOU SEE THAT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHAT DID YOU MEAN WHEN YOU SAID THAT YOU SUSPECTED THAT THE HDL ASSAY HAD FAILED?
ADAM ROSENDORFF: I SUSPECTED THAT THE THERANOS HDL WAS NO LONGER WORKING.
MR. BOSTIC: DOES THAT MEAN NO LONGER PROVIDING ACCURATE RESULTS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: IS THIS ANOTHER INSTANCE WHERE A RELATIVELY SMALL NUMBER OF PATIENT TEST RESULTS CAN INDICATE AN OVERALL PROBLEM WITH AN ASSAY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT THE BOTTOM OF PAGE 4, PLEASE. DANIEL YOUNG RESPONDS TO SUNNY BALWANI AND ELIZABETH HOLMES ABOUT THIS ISSUE; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: HE WRITES, "AT FIRST GLANCE THE HDL QC DATA," IS THAT QUALITY CONTROL DATA?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND "LOOKS TO BE RUNNING CONSISTENTLY LOW (VERY ROUGHLY 10 PERCENT LOW). THESE QC DATA SHOULD HAVE RAISED AN ALARM FLAG SEVERAL WEEKS AGO." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S GO TO PAGE 1 OF THIS EXHIBIT TO SEE YOUR RESPONSE. AND LET'S LOOK AT THE TOP MESSAGE. DO YOU SEE AN EMAIL THAT YOU SENT ON THIS ISSUE ON FEBRUARY 19TH?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL WAS SENT TO SUNNY BALWANI, DANIEL YOUNG, AND MARK PANDORI?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOU WRITE, "THE QC DRIFT TO THE LOW SIDE WOULD DEFINITELY NOT HAVE HELPED -- BUT WE'RE STILL WITHIN PROTOCOL." CAN YOU EXPLAIN WHAT YOU MEAN BY THAT?
ADAM ROSENDORFF: YES. THE LABORATORY WAS NOT PERMITTED TO RELEASE RESULTS UNTIL THE QC HAD PASSED. IF THE QC WAS 10 PERCENT LOWER THAN OUR TARGET VALUE, THAT WOULD STILL ALLOW RESULTS TO BE REPORTED.
MR. BOSTIC: AND SO HAD QC ACTUALLY PASSED IN THE CASE OF THIS PARTICULAR ASSAY DURING THIS TIME PERIOD?
ADAM ROSENDORFF: YES.
MR. BOSTIC: DID THE FACT THAT THE ASSAY HAD PASSED QC REMOVE YOUR CONCERNS ABOUT THE ACCURACY OF THOSE HDL RESULTS?
MR. BOSTIC: WHY NOT?
ADAM ROSENDORFF: BASED ON MY CLINICAL EXPERIENCE AND THE FACT THAT ONLY 5 PERCENT OF THE POPULATION SHOULD HAVE HDL'S IN THIS RANGE, I THOUGHT IT WAS VERY UNLIKELY THAT WE WOULD SEE A SPATE OF LOW HDL'S LIKE THIS.
MR. BOSTIC: IS THIS AN EXAMPLE OF THE WAYS IN WHICH QC CANNOT PROTECT AGAINST INACCURATE RESULTS GOING OUT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S GO BACK TO PAGE --
ADAM ROSENDORFF: I ALSO WANTED TO CLARIFY THAT THE QC MATERIAL IS A DIFFERENT MATERIAL FROM ACTUAL PATIENT SAMPLES.
MR. BOSTIC: CAN YOU EXPLAIN THAT? WHERE DOES QC MATERIAL COME FROM?
ADAM ROSENDORFF: IT'S MANUFACTURED IN THIS CASE BY BIORAD. IT HAS PRESERVATIVES, SALTS, PROTEINS, STABILIZERS, DETERGENT, ET CETERA. IT'S DESIGNED TO PERFORM LIKE SERUM. THERE ARE NO QC MATERIALS FOR CAPILLARY BLOOD AS FAR AS I'M AWARE.
MR. BOSTIC: ARE YOU MENTIONING THAT BECAUSE THAT'S ANOTHER REASON WHY A LAB NEEDS TO PAY ATTENTION TO ACTUAL PATIENT RESULTS THEMSELVES?
ADAM ROSENDORFF: YES, YES.
MR. BOSTIC: ON PAGE 3 OF THIS EXHIBIT. LET'S ZOOM IN ON THE MIDDLE OF THE PAGE, PLEASE, WHERE IT SAYS, "THE DATA LOOKS QUITE CLOSE." AND, DR. ROSENDORFF, DO YOU SEE A MESSAGE THAT YOU SENT IN THIS CHAIN?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU TALK ABOUT FOR THE FIVE PATIENTS WITH LOW HDL VALUES AND THEN YOU LIST THREE ITEMS?
ADAM ROSENDORFF: YES. YES.
MR. BOSTIC: AND CAN YOU DESCRIBE WHAT THOSE ITEMS ARE AND WHY YOU THOUGHT AT THE TIME THAT THEY MIGHT HAVE CONTRIBUTED TO THESE PROBLEMS?
ADAM ROSENDORFF: SURE. THE TECAN WAS THE LIQUID HANDLER THAT WAS DISPENSING THE SALINE OR THE WATER TO DILUTE THE CAPILLARY BLOOD SAMPLES, IT MAY HAVE BEEN AN ISSUE OF THE TECAN OVERDILUTING, AND, THEREFORE, LOWERING THE HDL CONCENTRATION. I DON'T RECALL WHAT MY THINKING WAS IN TERMS OF PREANALYTIC COLLECTION ISSUE. THE NEXT ISSUE IS REAGENT GETTING OLD AND SPORADICALLY PRODUCING LOW RESULTS. SO IF THE REAGENT IS BEYOND EXPIRATION OR IS OLD, THEN IT'S NOT GOING TO WORK AS INTENDED.
MR. BOSTIC: AND WAS USE OF THE TECAN IN THAT DILUTION METHOD NECESSARY WITH THE FDA APPROVED THIRD PARTY DEVICES?
MR. BOSTIC: NUMBER 2 TALKS ABOUT, FOR EXAMPLE, BAD CTN'S. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WERE CTN'S USED WITH THE FDA APPROVED THIRD PARTY DEVICES?
ADAM ROSENDORFF: NO. IN THE CASE OF THE HCG EMAIL WE WERE REVIEWING EARLIER, AN ATTEMPT WAS MADE TO USE A CTN WITH THE IMMULITE.
MR. BOSTIC: AND IS THAT THE BACKUP PLAN THAT WE WERE LOOKING AT BEFORE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: BUT THAT WASN'T PART OF THERANOS'S NORMAL DEFAULT WORKFLOW?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND NUMBER 3 TALKS ABOUT REAGENT GETTING OLD; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO MANUFACTURED THE REAGENT USED FOR THIS ASSAY?
ADAM ROSENDORFF: THERANOS. I'M SORRY, I JUST WANT TO CLARIFY. IN SOME INSTANCES THERANOS MANUFACTURED THE CHEMISTRY REAGENTS AND SOMETIMES THE SIEMENS REAGENTS WERE USED.
MR. BOSTIC: UNDERSTOOD. THANK YOU.
ADAM ROSENDORFF: YEAH.
MR. BOSTIC: WHO WAS RESPONSIBLE FOR MONITORING THE AGE OF REAGENTS USED AT THERANOS IN THE CLINICAL LAB?
ADAM ROSENDORFF: THAT WOULD BE DELEGATED TO THE TECHNICAL SUPERVISOR.
MR. BOSTIC: A THERANOS EMPLOYEE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND I'LL ASK YOU TO LOOK NOW AT EXHIBIT 1555, PLEASE. DO YOU SEE EXHIBIT 1555 IN FRONT OF YOU?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IS THIS ANOTHER EMAIL CHAIN RELATING TO HDL VALUES AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DOES IT INCLUDE YOU, SUNNY BALWANI, AND ELIZABETH HOLMES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1555. I UNDERSTAND IT'S BEEN STIPULATED TO.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1555 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN GO TO PAGE 4, PLEASE. LET'S ZOOM IN ON THE CONTENT OF THAT MIDDLE MESSAGE.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL THAT YOU SENT ON FEBRUARY 20TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL WAS SENT TO SUNNY BALWANI, DANIEL YOUNG, AND CC'ING ELIZABETH HOLMES; CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU SAY IN THE EMAIL, "I WOULD LIKE TO DISCONTINUE P-HDL TESTING, AND REVERT TO LIHEP VACUTAINER SAMPLES FOR HDL." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU TRANSLATE THAT FOR US? WHAT DOES THAT MEAN?
ADAM ROSENDORFF: I BELIEVE THERE'S A TYPO OR AN ERROR IN THIS EMAIL. WHAT I MEANT WAS I WOULD LIKE TO DISCONTINUE T-HDL TESTING AND THAT IS THE THERANOS METHOD AND REVERT TO LIHEP VACUTAINER SAMPLES FOR HDL.
MR. BOSTIC: AND WHAT DOES THAT MEAN?
ADAM ROSENDORFF: LITHIUM HEPARIN IS THE ANTICOAGULANT THAT IS PRESENT IN VACUTAINERS THAT ARE USED FOR COLLECTION OF VENOUS SAMPLES FOR HDL MEASUREMENT.
MR. BOSTIC: SO WHAT WERE YOU ACTUALLY SUGGESTING HERE, DISCONTINUING THE T-HDL TESTING REGARDING TO LITHIUM HEPARIN VACUTAINER, WHAT EFFECT WOULD THAT HAVE?
ADAM ROSENDORFF: I'M SORRY, COULD YOU REPEAT.
MR. BOSTIC: SURE. I'M JUST TRYING TO UNDERSTAND WHAT YOU WERE SUGGESTING HERE AND WHY.
ADAM ROSENDORFF: I WAS SUGGESTING TO CONTINUE THE THERANOS HDL TEST AND TO GO BACK TO THE PREDICATE TESTING. I DIDN'T FEEL THAT REPORTING THE HDL RESULTS USING THE THERANOS TEST WAS GOOD MEDICAL PRACTICE.
MR. BOSTIC: AND WHY AT THAT TIME DID YOU FEEL THAT IT WASN'T GOOD MEDICAL PRACTICE TO CONTINUE REPORTING THERANOS HDL TESTS?
ADAM ROSENDORFF: BECAUSE OF THE SPATE OF LOW HDL VALUES WERE BEING SEEN AND THERE WAS ALSO A STUDY COMPARING THE PREDICATES OF THE THERANOS TESTS FOR HDL WHICH SHOWED A NEGATIVE BIAS ON THE THERANOS TEST FOR HDL THAT'S IN A PREVIOUS EMAIL.
MR. BOSTIC: YOU DECIDED TO SEND THIS EMAIL TO SUNNY BALWANI AND INCLUDE ELIZABETH HOLMES; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHY DID YOU DECIDE TO SEND IT TO BOTH OF THEM?
ADAM ROSENDORFF: AT THIS POINT IN TIME I WASN'T CONFIDENT THAT RAISING THESE CONCERNS TO SUNNY AND DANIEL WAS GOING TO HAVE AN IMPACT, AND I WANTED TO MAKE SURE THAT ELIZABETH WAS AWARE OF THESE PROBLEMS, AND I THOUGHT THAT ELIZABETH HAD MORE POWER WITHIN THE COMPANY TO MAKE CORRECTIONS.
MR. BOSTIC: THIS REQUEST, THIS RECOMMENDATION TO DISCONTINUE THERANOS TESTING OF HDL, WAS IT A BIG DEAL?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WHY?
ADAM ROSENDORFF: HDL IS A PRETTY ROUTINELY MEASURED BREAD AND BUTTER ANALYTE PATIENT TEST, AND MANY PATIENTS WALK INTO WALGREENS WOULD HAVE GOTTEN THEIR CARDIO VASCULAR HEALTH CHECKED WITH A CHOLESTEROL TEST THAT WOULD INCLUDE HDL.
MR. BOSTIC: AND SO YOU TESTIFIED THAT IT WAS A COMMON TEST. WHY WOULD IT MATTER, THOUGH, TO SWITCH IT FROM A THERANOS METHOD TO A PREDICATE NON-THERANOS METHOD?
ADAM ROSENDORFF: I BELIEVE THAT THE PREDICATE METHOD WAS MORE ACCURATE. IN TERMS OF THE COMPANY, I GOT A LOT OF PUSHBACK WHEN I SUGGESTED REVERTING TO THE PREDICATE METHODS. THESE SUGGESTIONS WERE MET WITH NEGATIVITY. THEY DIDN'T GO DOWN WELL WITH MANAGEMENT.
MR. BOSTIC: AND LET'S BE CLEAR ABOUT WHO WE ARE TALKING ABOUT. WHEN YOU SAY, "MANAGEMENT," WHO DO YOU MEAN SPECIFICALLY?
ADAM ROSENDORFF: SUNNY, ELIZABETH, AND DANIEL, YEAH.
MR. BOSTIC: LET'S LOOK AT PAGE 2 OF THIS EXHIBIT, PLEASE. AND LET'S ZOOM IN ON THE TOP HALF. THERE'S AN EMAIL FROM DANIEL YOUNG TO YOU, MR. BALWANI, AND MS. HOLMES. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE SAYS, PLEASE HAVE THEM PREPARE FOR THE STUDY FOR TOMORROW MORNING. DO YOU RECALL A STUDY TAKING PLACE AROUND THIS TIME RELATING TO HDL?
ADAM ROSENDORFF: YES. AS REFERENCED IN THE PREVIOUS EMAIL, I WAS TRYING TO SOLVE THE PROBLEM. THE FIRST STEP WOULD BE TO CONTINUE PATIENT TESTING. THE SECOND STEP WOULD BE TO COLLECT MATCHING SAMPLES, FINGERSTICK AND VENOUS, FROM PATIENTS AND TO COMPARE THE RESULTS THAT WE GOT TO VERIFY THAT WOULD ALLOW US TO DETECT ANY SYSTEMATIC DIFFERENCES IN THOSE TWO METHODS AND TO START TROUBLESHOOTING FROM THERE.
MR. BOSTIC: MR. BALWANI RESPONDS TO THAT GROUP, INCLUDING MS. HOLMES AND YOU, SAYING, "WE MUST RESOLVE THIS ASAP. DANIEL PUT EVERYONE NEEDED ON THIS PROJECT INCLUDING SAM, EZER, NISHIT, AND TINA. WE CANNOT REVERT BACK TO VENIPUNCTURE FOR HDL." I WANT TO ASK YOU, HE WRITES "WE CANNOT REVERT BACK TO VENIPUNCTURE FOR HDL." DID YOU HAVE CONVERSATIONS WITH MR. BALWANI AROUND THIS TIME ABOUT THIS ISSUE OF REVERTING BACK TO THE PREDICATE METHOD?
ADAM ROSENDORFF: I DON'T RECALL THE SPECIFIC CONVERSATION ABOUT REVERTING BACK FOR HDL. IN GENERAL THERE WERE MANY CONVERSATIONS WITH HIM ABOUT REVERTING BACK TO VENIPUNCTURE THAT WERE MET WITH HOSTILITY.
MR. BOSTIC: DO YOU EVER RECALL A SITUATION WHERE MR. BALWANI WAS ENTHUSIASTIC OR FAVORABLE ABOUT THE IDEA OF TAKING A TEST OFF OF A THERANOS EQUIPMENT AND PUTTING IT BACK ON THE PREDICATE DEVICE?
MR. BOSTIC: HOW ABOUT MS. HOLMES? DO YOU EVER RECALL A SITUATION WHERE SHE WAS HAPPY ABOUT THE IDEA OF TAKING AN ASSAY OFF OF A THERANOS ANALYZER AND PUTTING IT BACK ON AN FDA APPROVED DEVICE?
ADAM ROSENDORFF: NO, SHE WAS NOT HAPPY ABOUT THAT IDEA.
MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 4116. YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4116. I UNDERSTAND THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: IT'S ADMITTED WITHOUT OBJECTION. BEFORE YOU BEGIN EXAMINATION ON THIS, LADIES AND GENTLEMEN, WHY DON'T YOU STAND UP AND STRETCH FOR JUST A MOMENT. PARDON ME, MR. BOSTIC. PARDON ME, DR. ROSENDORFF. YOU MAY STRETCH, TOO.
(GOVERNMENT'S EXHIBIT 4116 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: NO PROBLEM. THANK YOU, YOUR HONOR.
(STRETCHING.)
JUDGE DAVILA: AND EVERYONE ELSE, TOO. THANK YOU VERY MUCH, LADIES AND GENTLEMEN. MR. BOSTIC.
MR. BOSTIC: THANK YOU, YOUR HONOR.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL ON THE SCREEN WITH A SUBJECT LINE C02 OR BICARBONATE ISSUE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT IS C02 OR BICARBONATE IN THE CONTEXT OF LABORATORY TESTING?
ADAM ROSENDORFF: C02 IS A GAS THAT IS ELIMINATED BY THE LUNGS. IF YOU RETAIN C02, IT COULD INDICATE A LUNG PROBLEM.
MR. BOSTIC: LET'S LOOK AT PAGE 2 OF THIS EXHIBIT -- ACTUALLY LET'S GO BACK TO PAGE 1. LET'S ZOOM IN ON THE TOP HALF OF THE PAGE OR ACTUALLY THE MIDDLE OF THE PAGE CAPTURING THE WHOLE EMAIL MESSAGE. ARE YOU LOOKING, DR. ROSENDORFF, AT AN EMAIL THAT YOU SENT ON MARCH 31ST, 2014?
ADAM ROSENDORFF: YES, SIR.
MR. BOSTIC: AND YOU SENT IT TO MR. BALWANI AND MARK PANDORI; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THIS EMAIL, LIKE SOME OTHERS THAT WE HAVE SEEN, IS MARKED IMPORTANCE HIGH; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOU WRITE, "HI SUNNY. AT LEAST TWO-THIRDS OF OUR PATIENTS ARE READING BELOW THE NORMAL RANGE FOR BICARBONATE." YOU PROVIDE THE RANGE. YOU DO NOT EXPECT -- OR YOU SAY, "I DO NOT EXPECT OUTPATIENTS TO HAVE ABNORMAL BICARB VALUES. CURTIS'S STUDY WITH SIX DAYS OF DATA, (24 DATA POINTS) ALSO SHOWS THAT BICARB IS READING 30 PERCENT LOWER THAN MATCHED VENOUS EVEN AFTER CORRECTION OF THE VALUE FOR BIAS." CAN YOU EXPLAIN WHAT THE ISSUE WAS HERE AND WHY YOU WERE BRINGING IT TO MR. BALWANI'S ATTENTION?
ADAM ROSENDORFF: OBJECTIVELY TWO-THIRDS OF THE PATIENT'S RESULTS WERE COMING BACK BELOW THE NORMAL RANGE FOR BICARBONATES, AND THAT WAS JUST A FACT. CLINICALLY, I DID NOT EXPECT HEALTHY PATIENTS TO HAVE LOW BICARBONATE VALUES. I'M REFERENCING CURTIS, SCHNEIDER I BELIEVE HIS LAST NAME WAS, A RESEARCH AND DEVELOPMENT SCIENTIST WHO HAD DONE A STUDY OF MATCHING VENOUS AND FINGERSTICK SAMPLES AND HE FOUND BASED ON 24 DATA POINTS THAT THE BICARBONATE WAS READING 20 PERCENT LOWER IN THE FINGERSTICK VERSUS THE MATCHED VENOUS.
MR. BOSTIC: NOW, WHAT DOES THAT MEAN THE BICARB WAS READING 30 PERCENT LOWER IN FINGERSTICK THAN MATCHED VENOUS? CAN YOU EXPLAIN?
ADAM ROSENDORFF: SURE. SO THESE WOULD BE FOLKS, AND I BELIEVE THEY WERE THERANOS EMPLOYEES, WHERE THE EMPLOYEES WOULD BE PAID MONEY TO GET THEIR BLOOD DRAWN FROM THEIR ARM, A VENOUS DRAW, AND THEN THEY WOULD ALSO GET THEIR FINGERS PRICKED. THE BLOOD FROM THE ARM, THE VENOUS BLOOD, WOULD GO TO THE PREDICATE INSTRUMENT. SO THE BICARB WOULD BE MEASURED ON THAT. AND THEN THE FINGERSTICK WOULD GO TO THE -- WOULD ALSO GO TO THE PREDICATE INSTRUMENT, BUT IT WOULD BE RUN ON THE THERANOS LAB DEVELOPED TESTS AND THEN THOSE WOULD BE COMPARED TO EACH OTHER.
MR. BOSTIC: AND THIS SEEMS TO BE DISCUSSING THE DISCREPANCY BETWEEN THOSE TWO TYPES OF RESULTS; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT, CORRECT.
MR. BOSTIC: AND WAS THAT VIEWED AS A PROBLEM AT THERANOS?
ADAM ROSENDORFF: IT WAS VIEWED AS A PROBLEM. ROSE EDMONDS AND OTHER R&D SCIENTISTS THOUGHT IT WAS A BIG PROBLEM. I THOUGHT IT WAS A PROBLEM. I DON'T RECALL WHAT THE OPINION OF MANAGEMENT WAS, BUT I'LL JUST STOP THERE. OKAY.
MR. BOSTIC: WHY IS THIS A CAUSE FOR CONCERN IF THERE'S A MISMATCH BETWEEN A FINGERSTICK SAMPLE AND A VEIN SAMPLE, WHY IS THAT A PROBLEM?
ADAM ROSENDORFF: WELL, SAY, FOR INSTANCE, YOU HAD A PATIENT WITH A HIGH BICARBONATE VALUE AND THEN WE MEASURE THEIR BICARBONATE BY FINGERSTICK AND WE SHOW THAT IT IS IN THE NORMAL RANGE, WE WOULDN'T KNOW IF IT WAS TRULY NORMAL OR IF THERE WAS A PROBLEM WITH THE ASSAY. MY LEADING THEORY WAS THAT THE GAS WOULD ESCAPE FROM THE CTN'S AND THEN RESULTING IN LOWER BICARBONATE MEASUREMENTS.
MR. BOSTIC: SO DID THESE ISSUES HAVE YOU CAUSE YOU TO HAVE CONCERNS ABOUT THE ACCURACY OF THE OVERALL THERANOS BICARBONATE TESTS?
ADAM ROSENDORFF: YES. I BELIEVE EARLY ON WE STOPPED REPORTING BICARBONATE VALUES IN THE PATIENT REPORTS.
MR. BOSTIC: YOU MENTIONED THAT YOU THOUGHT A POSSIBLE CAUSE MIGHT BE GAS ESCAPING FROM THE CTN'S?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WERE CTN'S USED FOR FDA APPROVED TESTING ON THE PREDICATE DEVICES?
MR. BOSTIC: SO, IN OTHER WORDS, IS THIS A DISADVANTAGE OF THERANOS'S APPROACH?
ADAM ROSENDORFF: YES.
MR. BOSTIC: ON PAGE 1, IF WE CAN ZOOM OUT AND ZOOM BACK IN ON THE VERY TOP OF THE PAGE. THERE'S AN EMAIL FROM SUNNY BALWANI TO DANIEL YOUNG, PAUL PATEL, AND SAMARTHA ANEKAL. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE CC'S ELIZABETH HOLMES; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND FORWARDS THE INFORMATION BELOW; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 4189. YOUR HONOR, THE GOVERNMENT MOVES EXHIBIT 4189 INTO EVIDENCE. I BELIEVE THERE'S A STIPULATION.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4189 WAS RECEIVED IN EVIDENCE.)
ADAM ROSENDORFF: I DON'T APPEAR TO HAVE THAT. I'LL JUST LOOK AT IT ON THE SCREEN IF THAT'S ACCEPTABLE.
MR. BOSTIC: THAT'S FINE. THANK YOU. APOLOGIES FOR THAT.
MR. BOSTIC: THIS ONE IS EASY TO SEE ON THE SCREEN BECAUSE IT'S ONLY ONE PAGE. LET'S START WITH YOUR EMAIL AT THE TOP. IF WE CAN ZOOM IN ON THE EMAIL AT THE TOP PORTION OF THE PAGE. THANK YOU, MS. HOLLIMAN. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM YOU TO SUNNY BALWANI ON AUGUST 27TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IS THIS MORE DISCUSSION ABOUT C02 OR BICARBONATE RESULTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOUR EMAIL TO MR. BALWANI SAYS, "SUNNY, I AM THINKING THAT SINCE WE VOID ALL ABNORMAL BICARBONATE RESULTS, THE TEST HAS LOST ALL DIAGNOSTIC VALUE AND PROBABLY ALSO RELIABILITY WHEN RESULTS ARE REPORTED IN THE NORMAL RANGE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN WHAT THAT MEANS AND WHY YOU FELT THE NEED TO TELL SUNNY THIS?
ADAM ROSENDORFF: I BELIEVED IT WAS VERY LIKELY THAT C02 WAS ESCAPING FROM THE CTN'S. AFTER COLLECTION AND TRANSPORTATION TO THE LAB, THE BICARBONATE THAT WE WERE MEASURING WAS MUCH, MUCH LOWER THAN THE PATIENT'S TRUE BICARBONATE LEVEL; THAT THE BICARBONATE TEST LOSS ITS DIAGNOSTIC VALUE BECAUSE IT WASN'T REFLECTING THE TRUE BICARBONATE LEVEL IN THE PATIENT. AND THEN I POSE A SCENARIO WHERE A PATIENT HAS A TRULY HIGH BICARBONATE BUT BECAUSE THE C02 IS ESCAPING FROM THE CTN, THE BICARBONATE THEN COMES DOWN INTO THE NORMAL RANGE, AND, THEREFORE, WE WERE REPORTING A FALSELY NORMAL BICARBONATE VALUE WHEN, IN FACT, THE RESULT SHOULD BE HIGH.
MR. BOSTIC: AND WHY WOULD THAT BE A PROBLEM FOR A PATIENT TO GET A FALSELY NORMAL BICARBONATE RESULT?
ADAM ROSENDORFF: A PATIENT MIGHT HAVE SOME KIND OF OBSTRUCTIVE LUNG DISEASE THAT WOULD BE CAUSING THEM TO TRAP C02, IT WOULD EXPECT THEM TO HAVE A HIGH BICARBONATE VALUE, AND THIS WOULD BE MISLEADING TO THE CLINICIAN REGARDING THOSE KINDS OF MEDICAL PROBLEMS.
MR. BOSTIC: LET'S -- FIRST OF ALL, LET ME SEE IF YOU NOTE THAT AT THE TOP OF THIS PAGE MR. BALWANI FORWARDS YOUR MESSAGE TO ELIZABETH HOLMES ON AUGUST 27TH, 2014; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S ZOOM OUT AND LOOK AT THE MESSAGE BELOW THIS ONE. THIS IS AN EMAIL FROM MAX FOSQUE TO THE CLS EMAIL GROUP; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT. AND I'M CC'D AS WELL AS CHRISTIAN.
MR. BOSTIC: THANK YOU. AND THE SUBJECT LINE IS VOIDED C02 RESULTS. THIS WAS THE ORIGINAL EMAIL IN THAT CHAIN; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL READS, "ALL, PER ELIZABETH'S REQUEST, IN THE SHORT TERM, PLEASE DO NOT PUT ANY COMMENT/NOTE ON THE RESULT REPORT IF C02 VALUES ARE VOIDED. IF DOCTORS CALL TO INQUIRE, WE HAVE PROVIDED THE FOLLOWING MESSAGING TO THE CUSTOMER SERVICE TEAM: "'C02 RESULTS WERE NOT REPORTED DUE TO TEMPORARY UNAVAILABILITY OF THIS TEST FOR THIS SAMPLE. WE ARE GROWING AS FAST AS WE CAN AND ARE WORKING TO ENSURE THIS DOES NOT HAPPEN GOING FORWARD. WE APOLOGIZE FOR THE TEMPORARY INCONVENIENCE.'" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: DID YOU HAVE THOUGHTS AT THE TIME WHETHER THAT MESSAGE ACCURATELY DESCRIBED WHAT WAS HAPPENING WITH THE BICARBONATE TEST AT THERANOS?
ADAM ROSENDORFF: I DID NOT SEE ANY EFFORTS WITHIN THE COMPANY TO RECTIFY THIS PROBLEM, THEREFORE, I DID NOT THINK THAT IT WAS A TEMPORARY PROBLEM. I FIRMLY BELIEVED IT WOULD BE A PERMANENT PROBLEM, AND I DON'T THINK THIS MESSAGING IS TRANSPARENT.
MR. BOSTIC: WERE YOU SATISFIED WITH THE SOLUTION OF SIMPLY AVOIDING BICARBONATE TEST RESULTS IN RESPONSE TO THIS PROBLEM?
ADAM ROSENDORFF: I FELT AT THE TIME A BETTER SOLUTION WOULD BE NOT TO OFFER THE TEST, DON'T HAVE IT ON THE ORDER FORM AS AN AVAILABLE TEST IF WE KNOW WE CAN'T PERFORM IT.
MR. BOSTIC: AND WHY IS THAT? WHAT IS THE DIFFERENCE BETWEEN NOT OFFERING THE TEST IN THE FIRST PLACE OR JUST VOIDING THE RESULTS IF YOU'RE NOT CONFIDENT IN THEM?
ADAM ROSENDORFF: BECAUSE A DOCTOR HAS MADE A DECISION THAT HE OR SHE WANTS TO SEE THE BICARBONATE VALUE FOR A PATIENT FOR THEIR CLINICAL CARE. HIS OR HER EXPECTATION IS THAT THIS RESULT WILL BE RETURNED TO THEM IN A TIMELY MANNER AND WILL BE ACCURATE. THE COMPANY KNOWS THAT THEY'RE UNABLE TO DO BICARBONATE TESTING, YET THEY'RE MESSAGING IS THAT IT'S TEMPORARILY UNAVAILABLE.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 2009, PLEASE, AND WE'LL LOOK AT A DIFFERENT ASSAY. LET ME KNOW WHEN YOU GET TO EXHIBIT 2009 IN YOUR BINDER.
ADAM ROSENDORFF: GOT IT.
MR. BOSTIC: AND I'LL DIRECT YOU TO -- WELL, LOOKING AT THIS EMAIL CHAIN. IS THIS AN EMAIL CHAIN BETWEEN YOU AND OTHER EMPLOYEES AT THERANOS INCLUDING SUNNY BALWANI?
ADAM ROSENDORFF: YES. IT'S -- THE FIRST EMAIL IS FROM MYSELF TO SUNNY AND TO MAX FOSQUE.
MR. BOSTIC: AND DOES EMAIL RELATE TO LAB TEST RESULTS GENERATED IN THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES INTO EVIDENCE GOVERNMENT'S EXHIBIT 2009.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 2009 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: ACTUALLY, MS. HOLLIMAN, LET'S TAKE THIS DOWN AND REDACT THE PATIENT NAME AND DATE OF BIRTH.
MR. BOSTIC: IN THE MEANTIME, DR. ROSENDORFF, LET ME ASK YOU WHAT IS TESTOSTERONE AND HOW IS THAT ASSAY USED?
ADAM ROSENDORFF: TESTOSTERONE IS A HORMONE THAT IS PRESENT IN MALES AND TO A MUCH LESSER EXTENT IN FEMALES AND IT IS THOUGHT TO BE IMPORTANT FOR LEVELS IN MALES, SEXUAL DRIVE, AND JUST -- IT'S ALSO IMPORTANT FOR BUILDING MUSCLE.
MR. BOSTIC: AND DID THERANOS OFFER ANY TESTOSTERONE TESTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT DEVICE WAS USED TO RUN THE THERANOS TEST AT -- EXCUSE ME. WHAT DEVICE WAS USED TO RUN THE TESTOSTERONE TEST AT THERANOS?
ADAM ROSENDORFF: AT THIS POINT IN TIME IT WAS THE EDISON.
MR. BOSTIC: THANK YOU, MS. HOLLIMAN. LET'S GO TO PAGE 2 OF THIS EXHIBIT.
MR. BOSTIC: THERE'S MORE REDACTION TO BE DONE. WE CAN MOVE ON FROM THIS ONE MORE NOW.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 5397, PLEASE, DR. ROSENDORFF. DO YOU HAVE 5397 IN FRONT OF YOU?
ADAM ROSENDORFF: I DO.
MR. BOSTIC: AND IS EXHIBIT 5397 ANOTHER EMAIL CHAIN BETWEEN YOU AND OTHER INDIVIDUALS AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DOES THIS EMAIL RELATE TO LABORATORY RESULTS GENERATED BY THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 5397.
JUDGE DAVILA: ARE THERE REDACTIONS NEEDED ON THIS ONE AS WELL?
MR. BOSTIC: I BELIEVE THIS ONE THE REDACTIONS ARE COMPLETE, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
MR. BOSTIC: THANK YOU.
(GOVERNMENT'S EXHIBIT 5397 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, I'LL DIRECT YOUR ATTENTION TO THE BOTTOM HALF OF THIS PAGE. LET'S ZOOM IN IF WE CAN. DO YOU SEE THAT THIS EMAIL CHAIN BEGINS WITH SOMEONE NAMED STEVE MORIN TO YOU ON NOVEMBER 4TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE SUBJECT LINE IS REDRAW REQUEST?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO WAS STEVE MORIN AT THERANOS? DO YOU REMEMBER?
ADAM ROSENDORFF: I REMEMBER THAT HE HAD HIS CLINICAL LABORATORY SCIENTIST QUALIFICATION. I DON'T REMEMBER IF HE WAS A CLS OR A SUPERVISOR.
MR. BOSTIC: AND THE TEXT OF THE EMAIL SAYS, "FOR PATIENT," AND THEN THE PATIENT NAME IS REMOVED, "FOR VITAMIN D ON CTN, SAMPLE INTEGRITY, LIPEMIC, RESULTS NOT CONSISTENT." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN WHAT THAT IS CONVEYING?
ADAM ROSENDORFF: I DON'T KNOW WHAT HE MEANS BY SAMPLE INTEGRITY, LIPEMIC. I DO KNOW WHAT HE MEANS BY RESULTS NOT CONSISTENT.
MR. BOSTIC: CAN YOU EXPLAIN THAT FOR US?
ADAM ROSENDORFF: HE'S SAYING THERE WAS ONE RUN WHERE THE VITAMIN D RESULT WAS 132 AND THEN THE EXTRA RUN IT WAS GREATER THAN 200.
MR. BOSTIC: AND HOW IS THE VITAMIN D TEST USED IN THE MEDICAL SETTING?
ADAM ROSENDORFF: IT'S USED TO ASSESS NUTRITIONAL STATUS AND VITAMIN D IS ALSO IMPORTANT FOR BONE HEALTH.
MR. BOSTIC: WHEN MR. MORIN IS REFERENCING A FIRST RUN OF THE VALUE OF 132 AND A NEXT RUN OORH. WHAT DOES OORH STAND FOR?
ADAM ROSENDORFF: OUT OF RANGE HIGH.
MR. BOSTIC: AND WOULD THAT SIGNIFY A VALUE GREATER THAN 200?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHEN HE SAYS FIRST RUN AND NEXT RUN, WHAT IS THAT REFERRING TO?
ADAM ROSENDORFF: TWO CONSECUTIVE RUNS ON THE SAME SAMPLE.
MR. BOSTIC: AND THAT WAS MY QUESTION, THESE ARE TWO RUNS FROM THE SAME BLOOD SAMPLE FROM THE SAME PATIENT?
ADAM ROSENDORFF: I BELIEVE SO.
MR. BOSTIC: AND DOES THAT MEAN THAT YOU EXPECT THEM TO HAVE THE SAME OR VERY SIMILAR VALUES?
ADAM ROSENDORFF: CORRECT. CORRECT.
MR. BOSTIC: AND YOUR RESPONSE TO MR. MORIN ABOVE SAYS, "STEVE, WOULD THE FACT THAT THE SAMPLE IS LIPEMIC ACCOUNT FOR THE DISCREPANT RESULTS? I THINK IT WOULD MERELY INTRODUCE A CONSISTENT BIAS. THIS MAKES ME WORRY ABOUT THE REPRODUCIBILITY OF THE ASSAY." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID IT GIVE YOU CONCERNS ABOUT THE REPRODUCTION OF THE SIEMENS ADVIA?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DOES REPRODUCIBILITY HAVE ANYTHING TO DO WITH ACCURACY OR RELIABILITY?
ADAM ROSENDORFF: YES. IT HAS TO DO WITH THE RELIABILITY OF THE TEST.
MR. BOSTIC: HOW SO?
ADAM ROSENDORFF: WELL, FOR INSTANCE, THERE ARE OCCASIONS WHERE YOU NEED TO RERUN A TEST FOR WHATEVER REASON AND YOU WANT TO MAKE SURE THAT THE ORIGINAL VALUE AND THE REPEAT VALUE ARE CLOSE TOGETHER. IF, IF THE RESULT ON THE REPEAT TESTING IS ALL OVER THE PLACE, THAT JUST BRINGS INTO QUESTION THE ERROR WITHIN THE TEST, THE TEST IS ERROR PRONE.
MR. BOSTIC: AND IF YOU RUN THE SAME SAMPLE TWICE AND YOU GET VERY DIFFERENT RESULTS, CAN THEY BOTH BE CORRECT?
MR. BOSTIC: LET'S ZOOM OUT AND ZOOM IN ON THE TOP HALF OF THE PAGE, PLEASE. MR. MORIN RESPONDS TO YOU AND SAYS, "I AGREE, DIDN'T TRUST THE RESULTS, DECIDED IT WAS BEST TO BE CONSERVATIVE AND ASK FOR A REDRAW." WHAT WOULD IT MEAN AT THERANOS WHEN SOMEONE WOULD GET A REDRAW?
ADAM ROSENDORFF: EITHER THEMSELVES OR THE ORDERING PHYSICIAN WOULD BE NOTIFIED. I BELIEVE THERE WAS AN APP AND THEY WOULD BE NOTIFIED TO GO BACK TO THE PHARMACY AND HAVE THEIR FINGERS PRICKED AGAIN.
MR. BOSTIC: SO, IN OTHER WORDS, THIS WOULD BE STARTING THE WHOLE TEST PROCESS FROM THE BEGINNING; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT. CORRECT.
MR. BOSTIC: AT THE TOP OF THIS PAGE THERE'S AN EMAIL MESSAGE OR A FORWARD FROM ADAM ROSENDORFF TO A GMAIL ADDRESS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: CAN YOU EXPLAIN WHAT WE WERE LOOKING AT THERE?
ADAM ROSENDORFF: AT A CERTAIN POINT IN 2014 I STARTED TO FORWARD MYSELF EMAILS WITH ISSUES OF CONCERN. I FORWARDED THEM TO MY GMAIL ACCOUNT. I WASN'T CONFIDENT THAT THERANOS WOULD PRESERVE THESE EMAILS IN THE EVENT OF A CMS OR GOVERNMENT INVESTIGATION. I WANTED TO PROTECT MYSELF. I ALSO WAS AT THE TIME CONSIDERING A QUI TAM FALSE CLAIMS LAWSUIT BEING THE -- TO BE THE RELATOR ON SUCH A LAWSUIT. I BASICALLY -- I ALSO WANTED TO GET THE WORD OUT OF WHAT WAS GOING ON AT THERANOS.
MR. BOSTIC: WHEN YOU JOINED THE COMPANY, DID YOU ENTER INTO AN EMPLOYMENT CONTRACT OR OTHER -- DR. ROSENDORFF, IF YOU COULD LET ME -- BE SURE TO LET ME FINISH THE QUESTION FOR THE COURT REPORTER'S SAKE. THANK YOU. MY QUESTION WAS WHEN YOU JOINED THE COMPANY, DID YOU SIGN LEGAL DOCUMENTS LIKE AN EMPLOYMENT CONTRACT?
ADAM ROSENDORFF: CALIFORNIA -- YES, I SIGNED A NONDISCLOSURE AGREEMENT.
MR. BOSTIC: AND BY FORWARDING DOCUMENTS LIKE THIS TO YOUR PERSONAL EMAIL ACCOUNT, DID YOU BELIEVE OR UNDERSTAND THAT YOU WERE TAKING A RISK BY BREAKING THAT RULE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WHY DID YOU DECIDE TO DO IT ANYHOW?
ADAM ROSENDORFF: I FELT STRONGLY THAT THE PUBLIC BENEFITS OF THIS INFORMATION GETTING OUT WAS OF IMPORTANCE TO ME. I ALSO FELT FOR SELF-PROTECTION IN THE EVENT OF AN INVESTIGATION THAT SUCH A BENEFIT WOULD OUTWEIGH THE RISK OF BEING SUED BY THE COMPANY.
MR. BOSTIC: I NEED TO ASK THEN, AROUND THIS TIME IN NOVEMBER OF 2014, WERE YOU GIVING THOUGHT TO LEAVING THE COMPANY OR WHETHER YOU WOULD SAY AT THE COMPANY AT ALL?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WHEN DID THOSE THOUGHTS BEGIN, IF YOU RECALL?
ADAM ROSENDORFF: I WAS VERY ENTHUSIASTIC WORKING FOR THERANOS AT THE BEGINNING. OVER TIME I CAME TO REALIZE THAT THE COMPANY REALLY VALUED PR AND FUNDRAISING ABOVE PATIENT CARE. I GOT VERY DISILLUSIONED, AND I STARTED LOOKING FOR OTHER JOBS AROUND THE MIDDLE OF 2013. IT DID NOT IMPACT MY COMMITMENT TO PROVIDING THE HIGHEST QUALITY OF PATIENT CARE THAT I COULD AS LAB DIRECTOR. I WAS STILL VERY MUCH ENGAGED.
MR. BOSTIC: I JUST WANT TO MAKE SURE WE'RE CLEAR FOR THE RECORD.
ADAM ROSENDORFF: YEAH.
MR. BOSTIC: DID YOU SAY YOU BEGAN LOOKING FOR EMPLOYMENT --
ADAM ROSENDORFF: GO AHEAD, GO AHEAD.
MR. BOSTIC: DID YOU SAY YOU BEGAN LOOKING FOR OTHER EMPLOYMENT IN THE MIDDLE OF 2013 SHORTLY AFTER JOINING THE COMPANY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 2206, PLEASE. LET ME KNOW WHEN YOU HAVE EXHIBIT 2206 IN FRONT OF YOU THAT IS IN YOUR BINDER.
ADAM ROSENDORFF: I HAVE IT.
MR. BOSTIC: OKAY. IS EXHIBIT 2206 AN EMAIL CHAIN BETWEEN YOU AND OTHER INDIVIDUALS AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DOES IT RELATE TO LABORATORY RESULTS GENERATED WITHIN THE COMPANY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 2206.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: IT'S ADMITTED AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 2206 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: AND IF WE CAN LOOK AT PAGE 2, PLEASE. DO YOU SEE ON THE SCREEN IN FRONT OF YOU -- LET'S ZOOM IN ON THE MESSAGE KIND OF BEGINNING ONE-THIRD DOWN THE PAGE. LET'S SEE IF WE CAN CAPTURE FROM THERE DOWN, PLEASE. DR. ROSENDORFF, DO YOU SEE AN EMAIL IN FRONT OF YOU THAT WAS SENT TO YOUR THERANOS EMAIL ADDRESS ON NOVEMBER 14, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL SAYS, "HELLO DR. ROSENDORFF, AS YOU REQUESTED, I AM SENDING YOU INFORMATION ON LAB RESULTS ON TWO OF MY PATIENTS. THE RESULTS DO NOT APPEAR TO BE ACCURATE. I AM TRYING OUT THERANOS LAB AND ACCURACY IS VERY IMPORTANT. I WAS NOT AWARE THAT SOME OF THEIR METHODS ARE NOT FDA APPROVED." DO YOU SEE THAT?
ADAM ROSENDORFF: I SEE THAT.
MR. BOSTIC: AND YOU SAID YOU WOULD SOMETIMES INTERACT WITH DOCTORS CONCERNING TEST RESULTS; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S ZOOM OUT AND LET'S GO TO PAGE 3, PLEASE. LET'S START -- APOLOGIES. LET'S GO BACK TO 2 AND ZOOM IN JUST ON THE RESULTS BEGINNING HERE. YES, RIGHT HERE DOWN. DO YOU SEE SOME PATIENT RESULTS THAT WERE SUBMITTED BY THIS DOCTOR BY EMAIL TO YOU?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND NOW LET'S GO TO PAGE 3, PLEASE. LET'S ZOOM IN ON THE TOP HALF OF THE PAGE. DO YOU SEE SOME ADDITIONAL PATIENT TEST RESULTS AND A NOTE FROM THE DOCTOR, ALTHOUGH THIS PATIENT HAD AN -- THE RESULT FOR THIS PATIENT WAS HBA1C 4.6, BUT THERE'S A PARENTHETICAL THAT SAYS I'VE BEEN TESTING HER THE LAST FEW YEARS AND SHE HAS ALWAYS BEEN 5.5 TO 5.9. DO YOU SEE THAT?
ADAM ROSENDORFF: I SEE THAT.
MR. BOSTIC: LET'S ZOOM OUT AND ZOOM IN ON THE LAST LINE IN THE MIDDLE OF THE PAGE. LET'S CAPTURE WHAT IS BELOW THAT ALSO. THANK YOU. DO YOU SEE THE DOCTOR'S REACTIONS TO THOSE RESULTS? "I AM NOT SURE WHAT TO DO WITH THESE LAB RESULTS????"
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S GO TO PAGE 1 IN THIS EXHIBIT NOW. LET'S ZOOM IN ON YOUR MESSAGE IN THE TOP HALF OF THE PAGE, PLEASE. DR. ROSENDORFF, DO YOU SEE AN EMAIL THAT YOU SENT ON NOVEMBER 14TH, 2014, AT 5:05 P.M.?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU SAY, "I DID CALL HER." IS THAT REFERRING TO THE PHYSICIAN WHO SENT THE REPORT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU SAY, "UNFORTUNATELY I DO NOT HAVE A GOOD EXPLANATION FOR THE TESTOSTERONE DISCREPANCY." DOES THAT MEAN THAT THOSE RESULTS CAUSED YOU CONCERNS ABOUT THE ACCURACY OF THE RESULTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOU NEXT SAY, "THE SODIUM RESULTS OF 127 MILLIUNITS PER LITER IS CLEARLY ERRONEOUS GIVEN THE CLINICAL HISTORY." AT THE TIME DID YOU CONCLUDE THAT THAT RESULT GAVE YOU CONCERNS ABOUT THE ACCURACY OF THE SODIUM TEST?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AT THE BOTTOM OF YOUR EMAIL YOU SAY, "THE AIC RESULT IS ODD. IT WAS RUN ON THE DCA VANTAGE I ASSUME FROM FINGERSTICK." WAS THE DCA VANTAGE A THERANOS MODIFIED DEVICE?
MR. BOSTIC: AND YOU SAY, "WE SHOULD RUN HBA1C USING THE TOSOH G7 OR BIORAD VARIANT USING VENOUS BLOOD." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND AT THIS TIME WAS THE EDISON CAPABLE OF RUNNING AN HBA1C TEST?
ADAM ROSENDORFF: I DON'T RECALL.
MR. BOSTIC: LOOKING AT YOUR EMAIL ABOVE WHERE YOU'RE WRITING TO CHRISTIAN HOLMES. DO YOU SEE THAT AT THE TOP OF THE PAGE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU SAY, "I TOLD HER WE WOULD DO A TECHNICAL REVIEW -- UNFORTUNATELY OUR PRECISION STUDIES FOR THE EDISON HAVE ALL BEEN DONE ON VENOUS BLOOD -- WHICH DOES NOT REFLECT OUR ACTUAL WORKFLOW, I.E., TESTING SERIALLY ON FS IN THIS CASE." CAN YOU EXPLAIN WHAT YOU MEAN BY THAT?
ADAM ROSENDORFF: I'M NOT EXACTLY SURE WHAT ASSAY THIS IS REFERRING TO. THERE ARE A NUMBER OF THINGS MENTIONED IN THE PREVIOUS EMAIL SUCH AS SODIUM AIC, ET CETERA, SO I DON'T RECALL WHAT TEST I WAS REFERRING TO HERE.
MR. BOSTIC: LET ME ASK YOU GENERALLY, DO YOU RECALL FROM YOUR TIME AT THERANOS PRECISION STUDIES FOR EDISON BEING RUN ON VENOUS BLOOD?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EDISON WAS DESIGNED TO TEST FINGERSTICK SAMPLES; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHAT WAS YOUR UNDERSTANDING AS TO WHY VENOUS BLOOD WAS USED FOR THE PRECISION STUDIES ON THAT INSTRUMENT?
ADAM ROSENDORFF: IT WAS A PRACTICAL CONSIDERATION IN ORDER TO TEST BLOOD 20 TIMES FOR THE INTRO RUN PRECISION. YOU WOULD HAVE TO PRICK SOMEONE'S FINGER -- YOU WOULD HAVE TO GENERATE 20 CTN'S FROM MULTIPLE FINGER PRICKS BECAUSE WHAT HAPPENS IS AFTER YOU PRICK SOMEONE'S FINGER, AFTER A WHILE YOU CAN'T GET DROPS OF BLOOD OUT OF IT ANYMORE. IT STARTS GIVING YOU -- YOU CLOT UP. THAT'S WHAT HAPPENS AFTER GETTING YOUR FINGER PRICKED. SO TO ACTUALLY GET 20 FINGER PRICK SAMPLES, YOU WOULD PROBABLY HAVE TO PRICK EVERY FINGER ON A PATIENT. DOES THAT MAKE SENSE?
MR. BOSTIC: IT DOES.
ADAM ROSENDORFF: YEAH.
MR. BOSTIC: YOU SAY IN YOUR EMAIL, "UNFORTUNATELY OUR PRECISION STUDIES FOR THE EDISON HAVE ALL BEEN DONE ON VENOUS BLOOD." WHY WAS THAT UNFORTUNATE IF YOU RECALL?
ADAM ROSENDORFF: THINKING ABOUT IT NOW, I DON'T THINK PRACTICALLY WE COULD HAVE DONE IT ANY OTHER WAY.
MR. BOSTIC: DOES --
ADAM ROSENDORFF: I'M THINKING ABOUT A THEORETICAL IDEAL HERE.
MR. BOSTIC: UNDERSTOOD. WOULD A MISMATCH BETWEEN THE WAY PRECISION STUDIES ARE RUN AND THE WAY THE LAB ACTUALLY DOES ITS WORKFLOW AFFECT CONFIDENCE IN THE PRECISION STUDIES AT ALL?
ADAM ROSENDORFF: THE CONCERN IS THAT THERE'S A PREANALYTIC COMPONENT, IN OTHER WORDS, HOW DO YOU OBTAIN THE SPECIMEN, AND THAT'S GOING TO AFFECT PRECISION. SO IF YOU OBTAIN THE SPECIMEN USING A VACUTAINER, IT MAY GIVE YOU A DIFFERENT ESTIMATE OF PRECISION THAN IF YOU OBTAINED THE SPECIMEN USING A CTN.
MR. BOSTIC: I'LL ASK YOU TO LOOK AT 4124, PLEASE. LET ME KNOW WHEN YOU HAVE 4124 IN FRONT OF YOU?
ADAM ROSENDORFF: I HAVE IT.
MR. BOSTIC: IS EXHIBIT 4124 ANOTHER EMAIL CHAIN BETWEEN EMPLOYEES AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DOES IT INCLUDE MESSAGES TO OR FROM ELIZABETH HOLMES AND SUNNY BALWANI?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4124.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4124 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S GO TO PAGE 2, PLEASE, AND ZOOM IN ON THE BOTTOM OF THE TEXT MESSAGE THERE.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM MIKE PHEBUS TO KIMBERLY ALFONSO?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL READS: "HERE IS SOME FEEDBACK FROM KARI REEDY IN THE FIELD TODAY." DO YOU RECOGNIZE THAT NAME KARI REEDY?
ADAM ROSENDORFF: NO, I DO NOT.
MR. BOSTIC: AND THE FIRST BULLET POINT THERE SAYS, DR. STAMPS LIKES OUR LAB AND HAS SENT 3 PATIENTS. HE DOES NOT TRUST OUR POTASSIUM TEST, HOWEVER." AND THEN IT GOES ON TO DESCRIBE, "HE WAS CALLED LATE AT NIGHT REGARDING A PATIENT THAT HAD ABNORMALLY HIGH LEVELS OF POTASSIUM. THE PATIENT WAS IN NEW YORK CITY AT THE TIME OF THE CALL SO THE DOCTOR HAD TO CONTACT THEM WHILE THEY WERE OUT OF TOWN. THEY DID A RETEST IN NEW YORK AND THE RESULTS CAME BACK COMPLETELY NORMAL. DR. STAMPS SAID THAT POTASSIUM IS A TRICKY ONE TO COLLECT BECAUSE OF CLOTTING AND SUCH. HE ALSO MENTIONED THAT HE IS WILLING TO SHARE THE SPECIFIC PATIENT INFORMATION AND EXPLAIN THE EXPERIENCE IF SOMEONE WANTED TO REACH OUT TO HIM." DID I READ THAT CORRECTLY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WHAT IS POTASSIUM?
ADAM ROSENDORFF: POTASSIUM IS A -- IT'S AN ION. IT'S A CHEMICAL ELEMENT THAT IN A PATIENT IS IMPORTANT FOR CARDIAC FUNCTION AND NERVE CONDUCTION.
MR. BOSTIC: AND WOULD AN ABNORMALLY HIGH POTASSIUM RESULT BE A CAUSE FOR HARM AND IMMEDIATE RETEST?
ADAM ROSENDORFF: YES. CRITICAL HIGH TEST RESULTS COULD INDICATE THAT THE PATIENT IS AT RISK FOR A HEART RHYTHM PROBLEM. IT'S CALLED ARRYTHMIA.
MR. BOSTIC: LET'S LOOK AT PAGE 1 OF THIS EXHIBIT. LET'S ZOOM IN ON THE MIDDLE THIRD IF WE CAN. DANIEL YOUNG WRITES, "I'M NOT SURE THAT THIS DOCTOR WAS ASKING ABOUT THE CRITICAL VALUE FOR POTASSIUM. CRITICAL VALUE COMES FROM CLINICAL GUIDANCE DOCUMENTS AND CARE GUIDELINES, NOT FROM R&D." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S LOOK AT THE MESSAGE ABOVE THAT FROM MR. BALWANI. JUST CAPTURE THE WHOLE TOP OF THE PAGE, PLEASE. PERFECT. THANK YOU. DO YOU SEE AT THE BOTTOM OF THAT SELECTION MR. BALWANI RESPONDS, "BUT DO WE KNOW IF THIS RESULT WAS ACCURATE GIVEN THIS IS AN ISE ASSAY? THAT'S WHAT I WAS REFERRING TO." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: FIRST OF ALL, WHAT IS AN ISE ASSAY?
ADAM ROSENDORFF: ISE STANDS FOR ION SELECTIVE ELECTRODE. IT COMES PRE-INSTALLED ON SIEMENS INSTRUMENTS AND IS USED FOR MEASURING SODIUM, POTASSIUM, AND CHLORIDE.
MR. BOSTIC: AND WERE THESE ASSAYS THAT THERANOS RAN ON MODIFIED SIEMENS DEVICES OR UNMODIFIED SIEMENS DEVICES?
ADAM ROSENDORFF: MODIFIED.
MR. BOSTIC: DID THERANOS HAVE REPEATED PROBLEMS WITH ACCURACY OF THE ISE'S?
ADAM ROSENDORFF: YES, THEY DID.
MR. BOSTIC: DANIEL YOUNG RESPONDS TO MR. BALWANI TO SAY, "WE'LL HAVE TO CHECK. SOME POTASSIUM RESULTS CAN RUN HIGH WITH SLIGHT SAMPLE HEMOLYSIS." WHAT DOES HEMOLYSIS MEAN?
ADAM ROSENDORFF: HEMOLYSIS REFERS TO THE BURSTING OF RED BLOOD CELLS AND THE CONSEQUENT RELEASE OF LARGE AMOUNTS OF POTASSIUM INTO THE SERUM, PLASMA IN THE SAMPLE.
MR. BOSTIC: BASED ON WHAT YOU SAW AT THERANOS, WAS THAT SOMETHING MORE OR LESS LIKELY TO OCCUR FROM A FINGERSTICK DRAW VERSUS A VEIN DRAW?
ADAM ROSENDORFF: MUCH MORE LIKELY TO OCCUR FROM A FINGERSTICK DRAW. THE ONLY TIME IT WOULD OCCUR IN A VENOUS DRAW IS IF THE PHLEBOTOMIST USED THE WRONG KIND OF NEEDLE.
MR. BOSTIC: AND WHEN THERE WAS HEMOLYSIS PRESENT, DID IT HAVE AN EFFECT ON TESTING ACCURACY BASED ON WHAT YOU SAW?
ADAM ROSENDORFF: YES, IT WOULD SPURIOUSLY OR FALSELY ELEVATE THE POTASSIUM RESULT.
MR. BOSTIC: DANIEL YOUNG GOES ON TO SAY, "WE REVIEW THE IMAGINES FOR ALL SAMPLES FOR HIGH POTASSIUM RESULTS AND THEN CLIA DETERMINES IF A RERUN IS NEEDED OR NOT, AND HOW TO REPORT IT." DO YOU RECALL THIS PROCEDURE INVOLVING REVIEWING IMAGES FOR ALL SAMPLES WITH HIGH POTASSIUM RESULTS?
ADAM ROSENDORFF: MY RECOLLECTION IS THAT THE IMAGING WAS AVAILABLE ON THE EDISON BECAUSE THE EDISON HAD A CAMERA. I DO NOT RECALL IMAGING BEING AVAILABLE FOR TESTING THAT WAS RUN ON THE ADVIAS.
MR. BOSTIC: AND IF IMAGING WAS NOT AVAILABLE, WOULD IT STILL BE POSSIBLE, OR WOULD IT BE POSSIBLE TO DO A VISUAL INSPECTION OF THE SAMPLE?
MR. BOSTIC: WOULD REVIEWING IMAGES IN CASES WHERE POTASSIUM RESULTS WERE HIGH, SLOW DOWN THE TESTING PROCESS?
ADAM ROSENDORFF: DEFINITELY.
MR. BOSTIC: I'LL DIRECT YOUR ATTENTION TO THE EMAIL AT THE TOP OF THE CHAIN FROM MR. BALWANI TO MS. HOLMES. DO YOU SEE THAT ON APRIL 17TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE FORWARDED HER THE MESSAGES BELOW THAT WE HAVE BEEN LOOKING AT. "SEE BELOW. THIS IS WHAT WE ARE DOING TODAY WITH OUR LIMITED RESOURCES. THIS IS WHAT DANIEL HAS TO DO MANUALLY. NOT SCALEABLE." DO YOU SEE THAT?
ADAM ROSENDORFF: YEAH, I SEE THAT.
MR. BOSTIC: DO YOU AGREE WITH MR. BALWANI HERE THAT THAT KIND OF PROCESS WOULD PRESENT CHALLENGES -- I'M SORRY. LET ME START THAT QUESTION AGAIN. DO YOU AGREE WITH MR. BALWANI THAT THAT APPROACH WOULD PRESENT CHALLENGES WHEN IT CAME TO SCALING UP THERANOS'S PROCESS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 4127. DO YOU HAVE EXHIBIT 4127 IN FRONT OF YOU?
ADAM ROSENDORFF: I DO. I DO.
MR. BOSTIC: IS THIS ADDITIONAL EMAIL CORRESPONDENCE BETWEEN THERANOS EMPLOYEES RELATING TO THE SAME REPORT THAT WE WERE JUST LOOKING AT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4127.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4127 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, IS THIS STILL THIS DISCUSSION ABOUT HIGH POTASSIUM RESULTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND AGAIN, WHAT DEVICE WOULD BE YIELDING THESE HIGH POTASSIUM RESULTS?
ADAM ROSENDORFF: IT WOULD BE THE THERANOS LABORATORY DEVELOPED TESTS RUN ON THE ADVIA USING THE ION SPECIFIC ELECTRODE.
MR. BOSTIC: AND WERE TESTS RUN ON THERANOS MODIFIED DEVICES FDA APPROVED OR NOT FDA APPROVED?
ADAM ROSENDORFF: NOT FDA APPROVED.
MR. BOSTIC: I'LL ASK YOU TO LOOK AT THE BOTTOM OF PAGE 1. IF WE CAN JUST ZOOM IN ON THE HEADER INFORMATION THERE. WE SEE THAT WE'RE ABOUT TO LOOK AT AN EMAIL FROM SUNNY BALWANI TO INDIVIDUALS AT THERANOS, INCLUDING YOURSELF; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S GO TO PAGE 2, PLEASE. LET'S ZOOM IN ON THE TOP MESSAGE. DO YOU SEE MR. BALWANI'S EMAIL ON THE SCREEN?
ADAM ROSENDORFF: YES.
MR. BOSTIC: HE SAYS, "MAX, CAN YOU PLEASE WORK WITH DANIEL TO GET THE IMAGES OF THIS SAMPLE AND SEE IF THERE WAS ANY HEMOLYSIS (SOMEONE SHOULD HAVE BEEN FOLLOWING THIS PROCESS. THIS IS PART OF OUR CURRENT SOP)." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S GO BACK TO PAGE 1. PLEASE LET'S ZOOM IN ON YOUR EMAIL ON THE MIDDLE OF THE PAGE WITH THE HIGHLIGHTING. AND YOU WRITE, "ONE FURTHER OBSERVATION - I DO NOT BELIEVE THAT THE LEVELS OF HEMOLYSIS THAT WOULD RESULT IN A CTN POTASSIUM VALUE GREATER THAN 5.2 MM ARE NECESSARILY DETECTIBLE BY VISUAL INSPECTION BY A CLS." CAN YOU EXPLAIN WHAT YOU MEAN BY THAT?
ADAM ROSENDORFF: YES. I BELIEVED THAT YOU COULD STILL HAVE HEMOLYSIS IN A CTN, THAT THIS WOULD NOT BE DETECTABLE BY A CLS REVIEWING AN IMAGE OF A CTN.
MR. BOSTIC: WOULD THAT MEAN THAT THAT EXTRA STEP OF DOING THE VISUAL ANALYSIS WOULD NOT PROVIDE A GOOD ENOUGH SAFEGUARD TO THIS ISSUE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S ZOOM OUT AND THEN ZOOM IN ON THE TOP TWO MESSAGES ON THIS PAGE, PLEASE. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM SUNNY BALWANI TO ELIZABETH HOLMES NOW AND MAX FOSQUE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE IMPORTANCE IS MARKED HIGH. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: HE SAYS TO MS. HOLMES, "MAX IS GOING TO COME AND TALK TO YOU ABOUT THIS ISSUE. ADAM AND DANIEL CAN'T AGREE ON THIS AND HE IS IN THE MIDDLE OF THIS. WE NEED A RIGHT ANSWER FOR THIS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND DO YOU RECALL A DISAGREEMENT WITH DANIEL YOUNG OVER HOW TO HANDLE THIS ISSUE?
ADAM ROSENDORFF: DANIEL BELIEVED THAT HEMOLYSIS COULD BE RELIABLY DETECTED BY THE REVIEW OF THE CTN. ONE MAJOR PROBLEM IS THAT IN ROUTINE LAB PRACTICE, FOR INSTANCE, A PREDICATE FDA APPROVED INSTRUMENT WOULD DETECT HEMOLYSIS RIGHT AWAY. THIS WAS ALWAYS BEING DONE AFTER THE FACT. THAT'S ONE ISSUE. THE SECOND ISSUE IS THAT THE VISUAL INSPECTION OF THE CTN IMAGES WAS SOMEWHAT OF A COTTAGE INDUSTRY, KIND OF A -- IT WAS NOT SCIENTIFIC, IN MY OPINION, TO MAKE A DETERMINATION OF WHETHER THERE HAD BEEN HEMOLYSIS BASED ON VISUAL INSPECTION OF A CTN. THERE WERE OBVIOUS CASES WHERE THE PLASMA IS PINK.
MR. BOSTIC: YOU MENTIONED THAT THIRD PARTY DEVICES COULD DETECT HEMOLYSIS INSTANTLY. DID I HEAR YOU CORRECTLY?
ADAM ROSENDORFF: YES. YES.
MR. BOSTIC: CAN YOU EXPLAIN THAT?
ADAM ROSENDORFF: THE SIEMENS HAS WHAT ARE CALLED INDICES. YOU CAN TURN ON THE INDICES. THEY DETECT HEMOLYSIS, LIPEMIA, AND ICTERUS. AND THESE ARE KNOWN AS INTERFERING SUBSTANCES AND THEY'RE FLAGGED BY THIS SIEMENS INSTRUMENT AND OTHER CHEMISTRY ANALYZERS DURING THE RUN OF THE SAMPLE.
MR. BOSTIC: DID THE THERANOS EDISON HAVE THAT CAPABILITY?
ADAM ROSENDORFF: NO, IT DID NOT. BUT I THINK WE'RE TALKING ABOUT POTASSIUM HERE, SO THIS WOULD BE THE ADVIA.
MR. BOSTIC: OKAY. WE WERE TALKING ABOUT THE DISAGREEMENT THAT YOU HAD WITH DANIEL YOUNG ABOUT HOW TO APPROACH THIS ISSUE.
ADAM ROSENDORFF: YES.
MR. BOSTIC: MR. BALWANI ESSENTIALLY BRINGS IN MS. HOLMES IN ORDER TO MAKE A FINAL DECISION; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU RECALL MS. HOLMES WEIGHING IN ON THIS ISSUE AND MAKING THAT FINAL DECISION?
MR. BOSTIC: AT THE TOP OF THE PAGE THERE, ELIZABETH HOLMES RESPONDS TO MR. BALWANI AND SAYS, "FYI I AM MAKING SURE THIS LOOP GETS CLOSED WITH DR. STAMPS. PLEASE LET ME KNOW IF THERE ARE ANY OTHER OPEN WAG/PATIENT/PHYSICIAN RELATED ISSUES YOU ARE AWARE OF THAT I HAVE NOT OTHERWISE ALREADY REFERENCED IN MY EMAILS THIS AFTERNOON." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 1717. YOUR HONOR, I'M CONSCIOUS OF THE TIME. DO YOU WANT TO REMIND ME WHEN YOU WANT TO TAKE THE NEXT BREAK?
JUDGE DAVILA: WE WERE GOING TO DO IT AT 1:45. MAYBE NOW IS AN OPPORTUNE TIME BEFORE YOU MOVE ON TO ANOTHER TOPIC.
MR. BOSTIC: IT WOULD BE, YOUR HONOR.
JUDGE DAVILA: LET'S TAKE ANOTHER BREAK, FOLKS, A 20 MINUTE BREAK. THANK YOU. YOU MAY STAND DOWN.
(RECESS FROM 1:43 P.M. UNTIL 2:05 P.M.)
JUDGE DAVILA: THANK YOU. PLEASE BE SEATED. WE ARE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. THE JURY AND ALTERNATES ARE PRESENT. MR. BOSTIC.
MR. BOSTIC: THANK YOU, YOUR HONOR.
MR. BOSTIC: DR. ROSENDORFF, WE WERE ABOUT TO LOOK AT EXHIBIT 1717. COULD I ASK YOU TO TURN TO THAT IN YOUR BINDER, PLEASE.
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1717. I UNDERSTAND THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1717 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MAY WE PUBLISH, YOUR HONOR?
JUDGE DAVILA: YES.
MR. BOSTIC: MS. HOLLIMAN, LET'S START AT THE BOTTOM OF PAGE 2, PLEASE.
MR. BOSTIC: DR. ROSENDORFF, WE'RE BEEN TALKING ABOUT ISE ASSAYS. DO YOU RECALL OUR DISCUSSION?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHICH ASSAYS ARE INCLUDED IN ISE ASSAYS?
ADAM ROSENDORFF: SODIUM, POTASSIUM, AND CHLORIDE.
MR. BOSTIC: AND WHAT DEVICE, OR WHAT KIND OF DEVICE WAS THERANOS USING WHEN YOU WERE AT THE COMPANY TO RUN ISE TESTS?
ADAM ROSENDORFF: THE SIEMENS ADVIA 1800.
MR. BOSTIC: UM, THE SIEMENS ADVIA AS IT CAME FROM THE FACTORY OUT OF THE BOX?
ADAM ROSENDORFF: WE SPOKE ABOUT HOW THE SAMPLES WERE DILUTED. I KNOW THAT THE ION SENSITIVE ELECTRODE WAS USED ON THOSE SAMPLES FOR THOSE THREE ANALYTES. THERE MAY HAVE BEEN OTHER MODIFICATIONS THAT I WASN'T AWARE OF.
MR. BOSTIC: WERE THERANOS ISE TESTS CONDUCTED ON FINGERSTICK SAMPLES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: DID THE SIEMENS ADVIA DEVICES INCLUDE --
ADAM ROSENDORFF: I'M SORRY, I NEED TO CLARIFY. IF YOU'RE RUNNING SODIUM, POTASSIUM, OR CHLORIDE ON A VENOUS DRAW, YOU WOULD ALSO BE USING THE ION SENSITIVE ELECTRODE.
MR. BOSTIC: GENERALLY SPEAKING, DID --
ADAM ROSENDORFF: AND ION SELECTIVE ELECTRODE.
MR. BOSTIC: THANK YOU. GENERALLY SPEAKING AT THERANOS, WAS THE DEFAULT TO RUN ISE ASSAYS ON MODIFIED OR UNMODIFIED THIRD PARTY DEVICES?
ADAM ROSENDORFF: MODIFIED.
MR. BOSTIC: AND THAT WOULD ALLOW THE COMPANY TO USE FINGERSTICK SAMPLES?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: SO THE MATERIALS WE'VE BEEN LOOKING AT, THEY'VE BEEN RELATED TO THE PERFORMANCE OF THERANOS MODIFIED THIRD PARTY DEVICES?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WERE THOSE FDA APPROVED OR NOT?
ADAM ROSENDORFF: ONCE YOU USE A DIFFERENT SAMPLE TYPE OR METHOD OR YOU CHANGE THE INSTRUMENT IN ANY WAY, IT IMMEDIATELY BECOMES A LABORATORY DEVELOPED TEST.
MR. BOSTIC: AND LABORATORY DEVELOPED TEST MEANS NOT FDA APPROVED?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: DRAWING YOUR ATTENTION TO EXHIBIT 1717. THERE'S AN EMAIL ON YOUR SCREEN FROM SOMEONE NAMED HODA ALAMDAR?
ADAM ROSENDORFF: YES.
MR. BOSTIC: TO YOU AND MARK PANDORI; CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO WAS HODA ALAMDAR, IF YOU REMEMBER?
ADAM ROSENDORFF: CLINICAL LABORATORY SCIENTIST.
MR. BOSTIC: THIS EMAIL WAS ALSO SENT TO THE GROUP CLS; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND THE SUBJECT LINE IS ISE OUTPUT MAY 9TH, 2014. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: MS. ALAMDAR WRITES, "ALMOST EVERY ISE SAMPLE NEEDS A RERUN SINCE THEY'RE HIGH; MOST OF THE TIME THE RERUN VALUE IS ALSO HIGH OR THE SAME." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: DO YOU RECALL THIS BEING A PROBLEM WITH THERANOS ISE TESTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND COULD YOU DESCRIBE WHAT THIS MEANS?
ADAM ROSENDORFF: I THINK WHAT SHE'S REFERRING TO IS FOR INSTANCE, IF YOU HAD A POTASSIUM VALUE THAT WAS ABOVE THE REFERENCE RANGE, IT WOULD BE RERUN, OR A SODIUM VALUE THAT WAS BELOW THE REFERENCE RANGE, IT WOULD BE RERUN. YEAH.
MR. BOSTIC: AND WHAT IS THE SIGNIFICANCE, IF ANY, OF THE FACT THAT WHEN THESE SAMPLES WERE RERUN, THE VALUE AGAIN WOULD BE HIGH OR THE SAME? WHAT DID THAT TELL YOU AS LAB DIRECTOR AT THE TIME?
ADAM ROSENDORFF: IT SUGGESTS CONSISTENT BIAS.
MR. BOSTIC: AND IS BIAS A KIND OF INACCURACY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT THE EMAIL MESSAGE ABOVE THIS ONE IN THE MIDDLE OF THE PAGE, PLEASE. YOU FORWARD THIS INFORMATION TO MR. BALWANI; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND YOU SAY, "SUNNY, SORRY TO BOTHER YOU. I'D LIKE TO CORRECT OUR ISE PROBLEM. PLEASE SEE HODA'S EMAIL BELOW. IT IS MY OPINION THAT SODIUM, POTASSIUM, AND CHLORIDE SHOULD HAVE A DEDICATED CTN AND BE RUN NEAT ON THE ADVIA."
ADAM ROSENDORFF: YES.
MR. BOSTIC: CAN YOU EXPLAIN WHAT YOU WERE SUGGESTING THERE?
ADAM ROSENDORFF: YES. I WAS SUSPICIOUS OF THE THERANOS METHOD FOR SODIUM, POTASSIUM, AND CHLORIDE. IN PARTICULAR, THE DILUTION WAS LIKELY RESULTING IN THOSE -- THE CONCENTRATIONS OF THOSE ANALYTES GOING BELOW THE LOWER LIMIT OF DETECTION OF THE INSTRUMENTS. SO THAT -- YOU KNOW, THE INSTRUMENT IS ONLY DESIGNED TO DETECT TO A CERTAIN POINT, AND IF YOU GO BELOW THAT, YOU RUN INTO -- YOU START RUNNING INTO PROBLEMS. SO ONE SOLUTION THAT I SUGGESTED WAS TO COLLECT A SEPARATE CAPILLARY TUBE AND NANOTAINER FOR THOSE THREE ANALYTES AND TO RUN THEM WITHOUT DILUTION, IN OTHER WORDS, NEAT ON THE ADVIA.
MR. BOSTIC: AND THAT WOULD AVOID ANY PROBLEMS, IN THEORY AT LEAST, CAUSED BY THE DILUTION STEP?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S LOOK AT THE VERY TOP OF THIS PAGE. AND IF WE CAN ZOOM IN ON JUST THAT HEADER. DO YOU SEE ON MAY 9TH, 2014, MR. BALWANI SENT THIS EMAIL MESSAGE TO DANIEL YOUNG AND ELIZABETH HOLMES?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: AND LET'S GO TO PAGE 1, PLEASE. LET'S LOOK AT DANIEL YOUNG'S MESSAGE IN THE BOTTOM HALF OF THE PAGE. DO YOU SEE THIS RESPONSIVE EMAIL FROM DANIEL YOUNG?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND AT THIS POINT, WERE YOU STILL ON THE EMAIL CHAIN?
ADAM ROSENDORFF: I DON'T SEE A HEADER FOR THE 8:38 P.M. EMAIL FROM DANIEL. I DON'T BELIEVE I WAS.
MR. BOSTIC: OKAY. MR. YOUNG SAYS IN THAT MIDDLE PARAGRAPH OF HIS EMAIL, "RUNNING NEAT PLASMA IS AN OPTION, BUT NOT A VERY GOOD ONE CLEARLY." DO YOU AGREE THAT RUNNING NEAT PLASMA WOULD HAVE HAD SOME DISADVANTAGES?
ADAM ROSENDORFF: FOR THE COMPANY, YES. IT WOULD HAVE BEEN INCONVENIENT FOR THEM BECAUSE IT WOULD HAVE REQUIRED AN ADDITIONAL FINGERPRICK FOR THE PATIENT.
MR. BOSTIC: AND DANIEL YOUNG SAYS, "ALTERNATIVELY, WE HAVE BEEN LOOKING AT IMPLEMENTING A BIAS CORRECTION." GENERALLY SPEAKING, WHAT IS A BIAS CORRECTION?
ADAM ROSENDORFF: IF YOUR ASSAY IS SHOWING A CONSISTENT BIAS RELATIVE TO THE PREDICATE, YOU CAN APPLY A CORRECTION FACTOR TO BRING THOSE TWO VALUES INTO LINE WITH EACH OTHER. IF THERE'S INCONSISTENCY, IF THERE'S IMPRECISION, THAT'S NOT GOING TO WORK.
MR. BOSTIC: BUT IT'S A WAY TO COMPENSATE FOR CONSISTENT INACCURACY?
ADAM ROSENDORFF: FOR CONSISTENT BIAS, CORRECT.
MR. BOSTIC: LET'S ZOOM OUT AND LOOK AT THE TOP HALF OF THE PAGE. A LITTLE FURTHER DOWN. THAT'S PERFECT. DO YOU SEE AN EMAIL AT THE BOTTOM OF THIS SELECTION FROM ELIZABETH HOLMES ON MAY 9TH, AT 8:50 P.M.?
ADAM ROSENDORFF: YES.
MR. BOSTIC: MS. HOLMES SAYS IN RESPONSE TO DANIEL YOUNG, "I'LL TAKE A LOOK. IF THE BIAS CORRECTION IS ROBUST, WE SHOULD IMPLEMENT IT. WHAT IS TIMELINE ON THE FINAL SOLUTION?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DANIEL YOUNG RESPONDS TO HER EMAIL TO PROVIDE HER WITH THE REQUESTED INFORMATION AND SHE SAYS OKAY. DO YOU SEE THAT?
ADAM ROSENDORFF: YES, DANIEL SAYS THE STUDIES TO DETERMINE, ET CETERA, AND THEN ELIZABETH REPLIES OKAY.
MR. BOSTIC: OKAY. WE CAN PUT THAT ONE ASIDE. LET'S LOOK AT 4014. 4014. AND LET ME KNOW WHEN YOU HAVE THAT IN FRONT OF YOU.
ADAM ROSENDORFF: 4014?
MR. BOSTIC: 4014.
ADAM ROSENDORFF: I HAVE IT.
MR. BOSTIC: OKAY. IS EXHIBIT 4014 A CHAIN OF EMAILS INCLUDING INDIVIDUALS AT THERANOS, INCLUDING SUNNY BALWANI AND ELIZABETH HOLMES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4014.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4014 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S START, PLEASE, WITH THE BOTTOM OF PAGE 1, AND IF WE CAN CAPTURE THE EMAIL MESSAGE RIGHT THERE.
MR. BOSTIC: DR. ROSENDORFF, YOU'RE NOT ON THIS EMAIL EITHER; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND THIS IS AN EMAIL FROM DANIEL YOUNG TO SUNNY BALWANI AND ELIZABETH HOLMES; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND ON OCTOBER 17TH, 2013, DANIEL YOUNG WRITES AN EMAIL WITH THE SUBJECT LINE CLIA UPDATES. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT PAGE 2 OF THIS EMAIL, PLEASE. LET'S ZOOM IN AT THE BOTTOM OF THE PAGE ON LINE ITEM 3 ON THE LIST. THERE'S A HEADING IN THIS LIST TITLED ELECTROLYTES/ISE. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND MR. DANIEL YOUNG WRITES TO MS. HOLMES AND MR. BALWANI, "OUR NA, K, CI TEST RESULTS ARE STILL NOT AS RELIABLE AS I WOULD LIKE."
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT IS HE REFERRING TO THERE?
ADAM ROSENDORFF: THE SODIUM, POTASSIUM, AND CHLORIDE ASSAYS THAT ARE PERFORMED USING THE ION SELECTIVE ELECTRODE.
MR. BOSTIC: OKAY. AND THEY SAY -- HE SAYS THEY'RE STILL NOT AS RELIABLE AS HE WOULD LIKE. AROUND THIS TIME IN OCTOBER OF 2013, CAN YOU REMINDS US HOW LONG AFTER THE COMMERCIAL LAUNCH OF THE THERANOS TESTS WE WERE AT THIS POINT?
ADAM ROSENDORFF: APPROXIMATELY FIVE WEEKS.
MR. BOSTIC: WERE YOU AWARE THIS EARLY OF PROBLEMS PLAGUING THE ISE TEST AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID THOSE ISE PROBLEMS CONTINUE OVER THE MONTHS THAT YOU WERE LAB DIRECTOR AT THE COMPANY?
ADAM ROSENDORFF: YES. DO YOU WANT ME TO ELABORATE OR --
MR. BOSTIC: IF THERE'S MORE TO YOUR ANSWER.
ADAM ROSENDORFF: I WOULD COMPLAIN ABOUT THEM. FOLKS WOULD NOTE THE PROBLEM. DANIEL WOULD SAY HE'S WORKING ON A FIX, AND IN SOME INSTANCES HE WOULD SHOW ME DATA THAT SUGGESTED OR THAT INDICATED A FIX, AND THEN THE PROBLEMS MIGHT STABILIZE FOR A WHILE, BUT THEY WOULD COME BACK.
MR. BOSTIC: LET'S LOOK AT PAGE 1 OF THIS EXHIBIT. THE MIDDLE EMAIL FROM DANIEL YOUNG, JUST A QUICK UPDATE. WE JUST LOOKED AT AN EMAIL FROM OCTOBER 17TH. NOW WE'RE LOOKING AT AN OCTOBER 21ST EMAIL; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: DANIEL YOUNG SAYS TO SUNNY BALWANI AND ELIZABETH HOLMES, "JUST A QUICK UPDATE, WE STILL ARE HAVING ISE CHALLENGES. THERE ARE SEVERAL RESULTS RECENTLY THAT ARE OUT OF RANGE NORMAL THAT I DO NOT BELIEVE. SO AS A RESULT WE ARE NOT REPORTING THESE RESULTS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IS THIS CONSISTENT WITH YOUR MEMORY OF ISE ISSUES AT THIS TIME?
ADAM ROSENDORFF: YES, WE WERE NOT REPORTING RESULTS THAT WERE OUT OF RANGE, THAT WERE OUTSIDE OF THE REFERENCE RANGE, YEAH.
MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 1828. THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1828. I BELIEVE THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1828 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN GO TO PAGE 2 OF THIS EXHIBIT. LET'S ZOOM IN ON THE TEXT OF THE BOTTOM EMAIL THERE.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE THIS IS AN EMAIL THAT YOU SENT ON JUNE 25TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU WRITE TO DANIEL YOUNG AND SUNNY BALWANI; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOU SAY, "ALL, I WANTED TO GIVE SOME SUMMARY STATISTICS ON PERFORMANCE OF OUR POTASSIUM ASSAY SINCE IT WAS OPTIMIZED ON 5/24." DO YOU RECALL WHAT OPTIMIZED WOULD MEAN IN THIS CONTEXT?
ADAM ROSENDORFF: AT ONE POINT THERE WAS A CALIBRATION CURVE THAT WAS PUT ON THE SAME RUN AS THE PATIENT SAMPLES THAT APPEARED TO FIX THE PROBLEM, OR THAT I WAS TOLD WOULD FIX THE PROBLEM, AND SO I WANTED TO EVALUATE THE PERFORMANCE OF THE POTASSIUM ASSAY AFTER THAT FIX.
MR. BOSTIC: WHO WAS IT WHO TOLD YOU THAT THAT FIX WOULD ADDRESS THE PROBLEM?
ADAM ROSENDORFF: DANIEL, DANIEL YOUNG.
MR. BOSTIC: YOUR EMAIL TO DANIEL YOUNG AND SUNNY BALWANI ON THAT DATE INCLUDES SOME INFORMATION ABOUT RECENT RESULTS SINCE THAT OPTIMIZATION; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: BELOW THOSE RESULTS YOU LIST THREE IMPRESSIONS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND CAN YOU READ OR SUMMARIZE THOSE IMPRESSIONS FOR US?
ADAM ROSENDORFF: YES. BASED ON THE REFERENCE RANGE, YOU WOULD EXPECT 2.5 PERCENT OF POTASSIUMS TO BE ABOVE THE REFERENCE RANGE. WHAT WE WERE SEEING IS 10.3 PERCENT, THEREFORE, TOO MANY POTASSIUMS WERE BEING FLAGGED AS HIGH BASED ON THE REFERENCE RANGE THAT WE CHOSE.
MR. BOSTIC: AND CAN I ASK YOU ABOUT THAT? WHY WOULD THAT BE AN ISSUE? AS LAB DIRECTOR, WHY DID THAT CAUSE YOU CONCERN?
ADAM ROSENDORFF: AGAIN, IT WOULD POINT TO ACCURACY PROBLEMS. IT WOULD BE REPORTING OUT FALSELY HIGH POTASSIUM RESULTS TO PATIENTS AND THEIR PHYSICIANS.
MR. BOSTIC: AND IS THAT ADDRESSED IN THE FIRST BULLET POINT WHERE YOU SAY, "TOO MANY POTASSIUMS ARE FLAGGING HIGH BASED ON THE RR WE HAVE CHOSEN"?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT DOES RR STAND FOR?
ADAM ROSENDORFF: REFERENCE RANGE.
MR. BOSTIC: AND HOW ABOUT THE SECOND BULLET POINT? CAN YOU EXPLAIN TO US WHAT THE ISSUE WAS THERE?
ADAM ROSENDORFF: YES. SO I DON'T WANT TO GET TOO TECHNICAL, BUT YOU CHOOSE A REFERENCE RANGE BASED ON WHAT YOU SEE IN 95 PERCENT OF THE POPULATION. THAT LEAVES ANOTHER 5 PERCENT THAT WERE EXPECTED TO HAVE AN ABNORMAL RESULT. IT COULD EITHER BE A HIGH RESULT OR A LOW RESULT, SO THAT GIVES YOU 2.5 PERCENT ON EITHER END. SO WE WOULD EXPECT 2.5 PERCENT OF PATIENTS TO HAVE A LOW POTASSIUM. WHAT WE WERE OBSERVING WAS 1.4 PERCENT. THAT'S WHY I SAY TOO FEW POTASSIUMS ARE FLAGGING LOW.
MR. BOSTIC: AND HOW ABOUT THE THIRD BULLET POINT THERE? YOU SAY, "OUR TEST IS CURRENTLY NOT CAPABLE OF DIFFERENTIATING TRUE CRITICAL POTASSIUM FROM POTASSIUM ELEVATED DUE TO COLLECTION, OR, LESS LIKELY, ASSAY ISSUES, BECAUSE WE ARE ORDERING REDRAW FOR ALL POTASSIUM ABOVE A CERTAIN LEVEL." WHY WAS THAT A PROBLEM?
ADAM ROSENDORFF: IF YOU'RE REPORTING OUT A CRITICAL POTASSIUM, OTHERWISE KNOWN AS A PANIC VALUE, THAT REQUIRES IMMEDIATE ATTENTION, MEDICAL ATTENTION. AS WAS MENTIONED IN A PREVIOUS EMAIL, A PATIENT WAS ON VACATION IN NEW YORK AND HAD TO IMMEDIATELY GO GET THEIR POTASSIUM TESTED AND IT CAME OUT NORMAL. OBVIOUSLY IN A CASE WHERE A PATIENT HAS A NORMAL POTASSIUM AND YOU'RE REPORTING A CRITICAL RESULT, IT'S GOING TO RESULT IN A LOT OF ANXIETY AND INCONVENIENCE FOR THAT PATIENT AND THEIR FAMILIES. BY THE SAME TOKEN, YOU COULD HAVE A PATIENT WITH A CRITICAL POTASSIUM LEVEL, BUT I DIDN'T HAVE FAITH THAT -- BASICALLY I DIDN'T HAVE FAITH THAT THAT WAS A TRUE RESULT BECAUSE I MENTIONED THE ISSUES WITH COLLECTION AND WITH THE ASSAY. SO IF YOU VOID A CRITICAL POTASSIUM, THE PATIENT TRULY DOES HAVE A CRITICAL POTASSIUM, THEY COULD BE IN A LIFE THREATENING SITUATION THAT WOULDN'T BE ADDRESSED MEDICALLY.
MR. BOSTIC: LET'S ZOOM OUT AND LOOK AT THE EMAIL AT THE TOP OF THIS PAGE. THIS IS AN EMAIL FROM SUNNY BALWANI TO YOU AND DANIEL YOUNG; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND MR. BALWANI SAYS, "ADAM. I AGREE WE NEED TO RESOLVE THE POTASSIUM ISSUE. I AM ON THE ROAD THRU FRIDAY SO WILL SEND OUT A MEETING REQUEST FOR MONDAY. THANKS." AND THIS WAS ON MONDAY?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND DID YOU FEEL THAT THIS WAS AN ISSUE THAT COULD WAIT SEVERAL DAYS TO BE RESOLVED?
ADAM ROSENDORFF: IT WAS AN EMERGENT ISSUE. THE FACT THAT I TOLD THE LAB TO VOID THE CRITICAL RESULTS SOMEWHAT LESSENED THE MEDICAL IMPACT OF THIS ISSUE, BUT THIS COMPLAINT OF MINE HAD BEEN GOING ON SINCE THE YEAR BEFORE. IN MY MIND, IT WAS AN EMERGENT ISSUE, BUT IT WASN'T BEING VIEWED AS SUCH BY THE COMPANY.
MR. BOSTIC: UNDERSTOOD. LET'S LOOK AT PAGE 1 OF THIS EXHIBIT, PLEASE, AND LET'S ZOOM IN ON THE TEXT BELOW THE TABLE. FIRST, DO YOU SEE THIS IS PART OF AN EMAIL FROM DANIEL YOUNG TO YOURSELF AND MR. BALWANI?
ADAM ROSENDORFF: YES.
MR. BOSTIC: OKAY. LET'S ZOOM IN ON THAT TEXT. DO YOU SEE DANIEL YOUNG'S EMAIL INCLUDES A NUMBERED LIST PROVIDING HIS THOUGHTS ON WHAT MIGHT BE CAUSING THE ISSUE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE THAT BELOW THAT HE SAYS, "WE PLAN TO STUDY TO UNDERSTAND THESE FACTORS AND WILL THEN MAKE REFINEMENTS WHERE NEEDED. I THINK WE ARE VERY CLOSE TO HAVING PERFECTED OUR POTASSIUM ASSAY."
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID YOU AGREE WITH MR. YOUNG THAT THE COMPANY WAS CLOSE TO PERFECTING THE POTASSIUM ASSAY AT THAT TIME?
MR. BOSTIC: DID PROBLEMS WITH THE POTASSIUM ASSAY AND OTHER ISE'S CONTINUE AFTER JUNE 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND TO BE CLEAR, HOW LONG HAD THE COMPANY BEEN USING THIS POTASSIUM ASSAY ON ACTUAL PATIENTS AT THIS POINT?
ADAM ROSENDORFF: SINCE EARLY 2013.
MR. BOSTIC: LET'S JUST ZOOM IN BRIEFLY ON THE TOP OF THIS PAGE, PLEASE. DR. ROSENDORFF, DO YOU SEE AT THE TOP OF EXHIBIT 1828 MR. BALWANI FORWARDS THIS EMAIL, THIS INFORMATION TO ELIZABETH HOLMES ON JUNE 28TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 4292, PLEASE. YOUR HONOR, THE GOVERNMENT MOVES EXHIBIT 4292 INTO EVIDENCE. I BELIEVE THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4292 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S GO TO PAGE 2, PLEASE. LET'S ZOOM IN ON THE BOTTOM EMAIL.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM OCTOBER 2014 FROM SOMEONE NAME ANAM KHAN?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO WAS ANAM KHAN?
ADAM ROSENDORFF: A CUSTOMER SERVICE REPRESENTATIVE.
MR. BOSTIC: AND THE SUBJECT LINE OF THE EMAIL IS CRITICAL ISE'S; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE TEXT OF THE EMAIL SAYS -- THE PATIENT'S NAME IS REDACTED, BUT HE INDICATES THAT THE PHYSICIAN CALLED TODAY ASKING WHY ISE'S WEREN'T INCLUDED ON HER FINAL REPORT. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: A COUPLE LINES DOWN HE SAYS -- ACTUALLY, JUST CONTINUING ON. HE SAYS, "ONLY COMP WAS ORDERED, BUT ISE'S WERE VOIDED, SO I EXPLAINED THAT THE PATIENT WOULD NEED TO COME BACK IN TO BE REDRAWN." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT DID THAT MEAN AGAIN WHEN ISE RESULTS WERE VOIDED?
ADAM ROSENDORFF: IF THEY WERE ABOVE OR BELOW THE REFERENCE RANGE, THEY WOULD NOT APPEAR AS VALUES AND THE STATEMENT WOULD APPEAR ON THE REPORTS VOIDED BY LABORATORY.
MR. BOSTIC: THE EMAIL GOES ON TO SAY, "THE LADY I SPOKE TO MENTIONED THAT THEY REALLY NEEDED THE SODIUM RESULT BECAUSE THE PATIENT HAD LOW SODIUM LEVELS AND THAT'S WHAT THEY WERE CHECKING. I NOTICED THE SODIUM RESULTS WERE CRITICAL LOW SO I ASSUME THAT'S WHY WE VOIDED IT. IS IT POSSIBLE THAT THAT WAS THE TRUE VALUE? IF SHE COMES IN AGAIN AND THE VALUE IS STILL CRITICAL LOW, WILL IT JUST BE VOIDED AGAIN?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IS THIS AN EXAMPLE OF WHY THIS PRACTICE CAUSED YOU CONCERN AT THERANOS?
ADAM ROSENDORFF: YES. YES. THIS WAS A PATIENT WITH A HISTORY OF LOW SODIUM THAT BY POLICY WE WERE VOIDING LOW SODIUMS, SO THIS TEST WAS OF NO VALUE TO HER.
MR. BOSTIC: AND WE SPOKE EARLIER ABOUT THE ALTERNATIVE OF JUST NOT OFFERING THE TEST TO BEGIN WITH?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: DID YOU FEEL AT THIS TIME THAT THAT OPTION WOULD HAVE BEEN A BETTER SERVICE TO THIS INDIVIDUAL PATIENT?
ADAM ROSENDORFF: I THINK THAT NOW. I BELIEVE THAT NOW. I DIDN'T GO THROUGH THAT THOUGHT PROCESS AT THE TIME, YEAH.
MR. BOSTIC: LET'S LOOK AT HOW YOU RESPONDED AT THE TIME. LET'S ZOOM BACK OUT AND ZOOM BACK IN ON THE MESSAGE DIRECTLY ABOVE THAT ONE. LET'S INCLUDE THE HEADER. THANK YOU. DO YOU SEE AN EMAIL FROM YOU ON OCTOBER 27TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND TO WHOM DID YOU SEND THIS EMAIL?
ADAM ROSENDORFF: TO BOTH SUNNY BALWANI AND ELIZABETH HOLMES.
MR. BOSTIC: YOUR EMAIL SAYS, "I WANTED TO BRING THIS IMPORTANT ISSUE TO YOUR ATTENTION. RIGHT NOW, AFTER MUCH COOPERATIVE DISCUSSION BETWEEN CLIA AND R&D AND THOUGHT, IF THE CTN SODIUM IS BELOW 120 MM OR ABOVE 160 MM, WE END UP VOIDING THE RESULT, BECAUSE WE HAVE NO WAY OF KNOWING FOR SURE WHETHER THE RESULT IS TRULY ABNORMAL OR ARTIFACTUAL TO THE ASSAY, OR RELATED TO A SPECIMEN INTEGRITY ISSUE." DID I READ THAT CORRECTLY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU MENTIONED THAT THERE ARE CONDITIONS WHERE PATIENTS CAN ACTUALLY HAVE A CRITICAL SODIUM LEVEL AND THAT WOULD BE THEIR GENUINE RESULT; IS THAT TRUE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND YOU THEN HIGHLIGHT THE EXAMPLE BELOW THAT WAS SENT TO YOU AND YOU SAY, "I AM NOT SURE OF THE CLINICAL VALUE OF A SODIUM ASSAY, WHICH IN THE ONLY TIME WE CAN REPORT IT IS WHEN IT IS NOT CRITICAL, AND THE VERY SITUATIONS THAT REQUIRE ACCURATE MEASUREMENT AND REPORTING OF ABNORMAL OF SODIUM RESULTS ARE VOIDED." CAN YOU EXPLAIN WHAT YOU MEANT BY THAT?
ADAM ROSENDORFF: YES. THIS IS A PATIENT WITH A MEDICAL CONDITION THAT RESULTS IN A HIGH SODIUM. IT'S FOR THEIR -- IT'S THEIR OWN DDAVP, WHICH IS THE TREATMENT. AND THAT LOWERS THE SODIUM. IT'S CRITICALLY FOR DRUG MONITORING. FOR MONITORING WHETHER THIS DDAVP TREATMENT IS EFFECTIVE, IT'S CRITICAL THAT THE SODIUM IS MEASURED ACCURATELY. IF THE PATIENT IS NOT BEING TREATED APPROPRIATELY, THEY WOULD STILL HAVE A HIGH SODIUM, BUT THE LABORATORY WOULD SAY, OH, WELL, WE HAD TO VOID THIS. SO THAT'S WHERE THE ASSAY REALLY HAS ITS CLINICAL VALUE, AND THOSE ARE THE TIMES WHEN WE WOULD END UP VOIDING THE RESULTS.
MR. BOSTIC: AND WAS YOUR CONCERN THAT THE THERANOS ASSAY WAS NOT DELIVERING THAT CLINICAL VALUE AT THIS TIME?
ADAM ROSENDORFF: YES, YES.
MR. BOSTIC: YOUR EMAIL GOES ON TO SAY, "ALL OF US IN CLIA SHARE THE SAME CONCERNS. HOW IS THE 4S SODIUM DOING? MAYBE WE CAN USE THE 4S FOR ISE'S?" WHAT WERE YOU SUGGESTING THERE?
ADAM ROSENDORFF: I HAD HEARD FROM OTHER FOLKS AND BY EMAIL THAT THE 4S WAS IN DEVELOPMENT. THIS WAS AN INSTRUMENT IN DEVELOPMENT THAT COULD DO BOTH COMPLETE BLOOD COUNTS AND GENERAL CHEMISTRY ASSAYS. I WAS REALLY STRUGGLING, GRASPING AT STRAWS TRYING TO FIND AN ALTERNATIVE WAY OF MEASURING SODIUM USING A THERANOS METHOD.
MR. BOSTIC: AND YOU THOUGHT MAYBE THIS NEXT GENERATION DEVICE MIGHT BE THE ANSWER?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND DID YOU LEAVE THERANOS STILL HAVING NEVER SEEN ONE OF THESE NEXT GENERATION DEVICES?
ADAM ROSENDORFF: NEVER SAW IT.
MR. BOSTIC: LET'S LOOK AT PAGE 1 OF THIS EMAIL, AND LET'S ZOOM IN ON THE MIDDLE MESSAGE FROM MR. BALWANI. THANK YOU. MR. BALWANI RESPONDS TO THIS CHAIN TO SAY, "I HAVE NOT HEARD ANY ISSUES ON ADVIAS OR ISE'S, BUT I KNOW THERE ARE ISSUES THAT ARE NOW CAUSING US A LOT OF PAIN." AT THIS POINT IN OCTOBER OF 2014, HAD YOU SPECIFICALLY DISCUSSED ISE ISSUES ON ADVIAS WITH MR. BALWANI?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 4182. LET ME KNOW WHEN YOU HAVE EXHIBIT 4182 IN FRONT OF YOU.
ADAM ROSENDORFF: I HAVE IT.
MR. BOSTIC: OKAY. I'LL ASK YOU TO PLEASE LOOK AT PAGE 3 OF THE EXHIBIT. DO YOU SEE THIS IS AN EMAIL CHAIN BETWEEN INDIVIDUALS AT THERANOS INCLUDING MAX FOSQUE, DANIEL YOUNG, SUNNY BALWANI, AND CHRISTIAN HOLMES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE THAT THIS EMAIL RELATES TO A PARTICULAR LAB RESULT GENERATED AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE THAT IT'S CHECKED IMPORTANCE LEVEL HIGH IN THE EMAIL?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4182.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: MR. BOSTIC, ARE YOU ASKING THAT THIS BE ADMITTED FOR A SPECIFIC PURPOSE?
MR. BOSTIC: YOUR HONOR, I CAN MOVE ON FROM THIS ONE FOR NOW.
MR. BOSTIC: LET'S LOOK INSTEAD, DR. ROSENDORFF, AT EXHIBIT 4298, PLEASE.
ADAM ROSENDORFF: OKAY.
MR. BOSTIC: AND DO YOU SEE THAT EXHIBIT 4298 IS AN EMAIL INCLUDING SUNNY BALWANI AND ELIZABETH HOLMES?
ADAM ROSENDORFF: THE EMAIL AT THE TOP OF THE PAGE, YES, AT THE TOP OF THE EXHIBIT.
MR. BOSTIC: AND DO YOU SEE THAT THE SUBJECT LINE IS CRITICAL ISE'S?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4298.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4298 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DO YOU RECALL LOOKING AT THIS EMAIL CHAIN EARLIER, AND I'LL DIRECT YOU TO PAGE 3 OF THE EXHIBIT. AND LET'S ZOOM IN ON THE BOTTOM HALF OF THE PAGE, PLEASE. DO YOU RECALL, DR. ROSENDORFF, WE WERE RECENTLY LOOKING AT THIS EMAIL CHAIN ABOUT CRITICAL ISE'S?
ADAM ROSENDORFF: DURING MY TESTIMONY TODAY, YES.
MR. BOSTIC: YES. AND MR. BALWANI ON THE BOTTOM OF THE PAGE SAYS THAT HE HAS NOT HEARD OF ANY ISSUES ON ADVIAS OR ISE'S, AND I ASKED YOU WHAT YOU THOUGHT OF THAT STATEMENT.
ADAM ROSENDORFF: I DON'T THINK IT'S A GENUINE STATEMENT. I DON'T THINK HE'S BEING GENUINE, NO.
MR. BOSTIC: LET ME ASK YOU TO LOOK AT PAGE 2 OF THIS EXHIBIT. AND LET'S GO THERE, MS. HOLLIMAN. LET'S ZOOM IN ON THE TOP HALF OF THAT PAGE. DO YOU SEE AT THE TOP THERE AN EMAIL FROM TINA LIN TO NISHIT DOSHI, SUNNY BALWANI, AND DANIEL YOUNG?
ADAM ROSENDORFF: YES.
MR. BOSTIC: SHE SAYS, "WE SHOULD ALSO CONSIDER WHETHER XPT WILL SOLVE THE PROBLEMS WE'RE CURRENTLY SEEING." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU KNOW WHAT XPT IS REFERRING TO?
ADAM ROSENDORFF: THIS IS A NEW MODEL OF THE ADVIA WITH HIGHER THROUGHPUT.
MR. BOSTIC: AND IS THIS ANOTHER THIRD PARTY DEVICE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WAS THIS NEW MODEL OF THE ADVIA INVENTED OR DEVELOPED OR MANUFACTURED BY THERANOS?
ADAM ROSENDORFF: NO. IT WAS A SIEMENS INSTRUMENT.
MR. BOSTIC: DO YOU KNOW AT THIS TIME WHETHER THERANOS WAS CONSIDERING PURCHASING ONE OR MORE XPT ANALYZERS FROM SIEMENS?
ADAM ROSENDORFF: AT THIS POINT I BELIEVE THERANOS HAD ALREADY PURCHASED SOME XPT INSTRUMENTS.
MR. BOSTIC: AND IS IT YOUR RECOLLECTION THAT THERANOS PURCHASED ADDITIONAL SIEMENS XPT INSTRUMENTS BEFORE COMPLETING WORK ON ITS 4S OR MINILAB DEVICES?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: OKAY. WE CAN PUT THAT ONE ASIDE. LET'S LOOK AT EXHIBIT 1953, PLEASE. DO YOU HAVE EXHIBIT 1953 IN FRONT OF YOU?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WE SPOKE ABOUT ISE'S. DO YOU SEE IN FRONT OF YOU AN EMAIL CHAIN RELATING TO CALCIUM RESULTS AT THERANOS?
ADAM ROSENDORFF: I SEE AN EMAIL FROM CHRISTIAN TO HIS SISTER, ELIZABETH, ABOUT A CANDID CONVERSATION SAYING THAT THERE ARE ISSUES WITH CALCIUM, POTASSIUM, AND SODIUM.
MR. BOSTIC: LET ME DIRECT YOU TO PAGE 2 OF THE EXHIBIT.
ADAM ROSENDORFF: AH. OKAY. I SEE AN EMAIL FROM ERIC NELSON TO MIKE PHEBUS COPYING KIMBERLY ALFONSO REGARDING HIGH POTASSIUM -- THE HIGH CALCIUM LEVEL.
MR. BOSTIC: AND AS YOU POINTED OUT, THE EMAIL CHAIN EVENTUALLY CULMINATES IN AN EMAIL FROM CHRISTIAN HOLMES TO ELIZABETH HOLMES; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1953.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1953 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S START ON PAGE 2, PLEASE. LET'S ZOOM IN ON THE TEXT OF THE BOTTOM EMAIL MESSAGE THERE.
MR. BOSTIC: FIRST OF ALL, BEFORE WE DO THAT, DR. ROSENDORFF, DO YOU SEE THAT THE FIRST EMAIL IN THIS CHAIN IS FROM ERIC NELSON TO MIKE PHEBUS AND KIMBERLY ALFONSO?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WERE THE ROLES OF THESE INDIVIDUALS AT THERANOS, IF YOU RECALL?
ADAM ROSENDORFF: I DIDN'T KNOW MIKE PHEBUS. I RECOGNIZED KIMBERLY'S NAME. AS I MENTIONED BEFORE, I'M NOT SURE OF HER EXACT ROLE.
MR. BOSTIC: THE EMAIL FROM ERIC NELSON READS, "MIKE AND KIMBERLY, FOUNTAIN HILLS OFFICE HAS HAD A COUPLE OF ISSUES." HE NOTES THAT THIS REPORT IS COMING FROM FOUNTAIN HILLS PEDIATRIC AND INTERNAL MEDICINE. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S ZOOM IN ON THE REPORT BELOW. THE REPORTED ISSUE SAYS, "I HAVE HAD 5-6 CALCIUMS LEVELS COME BACK RECENTLY THAT WERE OVER 10 (HYPERCALCEMIA). THESE PATIENTS HAVE NEVER HAD HIGH CALCIUM IN THE PAST. SENT ALL PATIENTS TO SQ TO RETEST AND THE CALCIUM LEVELS ARE UNDER 10 (NORMAL)." CAN YOU EXPLAIN WHAT THAT WOULD SIGNIFY TO YOU?
JUDGE DAVILA: CAN YOU LAY A FOUNDATION?
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, YOU TESTIFIED THAT IN YOUR ROLE AS LAB DIRECTOR, YOU WOULD FREQUENTLY FIELD COMPLAINTS AND QUESTIONS FROM MEDICAL PROVIDERS.
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND IS WHAT YOU'RE LOOKING AT SUCH A COMPLAINT FROM A MEDICAL PROVIDER?
ADAM ROSENDORFF: YES, IT APPEARS TO BE A COMPLAINT FROM A PHYSICIAN ASSISTANT THAT WAS COMMUNICATED TO ERIC NELSON. I DON'T BELIEVE THIS MADE ITS WAY TO ME, THOUGH.
MR. BOSTIC: YEAH. OKAY. LET ME JUST ASK YOU, THE TERM USED IN THE SECTION I JUST READ, "HYPERCALCEMIA," CAN YOU JUST DEFINE THAT? WHAT IS HYPERCALCEMIA?
ADAM ROSENDORFF: CALCIUM IS A CHEMICAL ELEMENT. IT CAN BE HIGH BECAUSE OF ABSORPTION FROM BONE OR RENAL PROBLEMS. IF IT'S HIGH, IT CAN RESULT IN DEPOSITS IN VARIOUS TISSUES AND CAUSE PROBLEMS.
MR. BOSTIC: THE DOCTOR CONTACTING THERANOS IN THIS EMAIL REPORTS THAT SHE HAD PATIENTS COME BACK RECENTLY WITH HIGH CALCIUM RESULTS HAVING NEVER HAD HIGH CALCIUM IN THE PAST. DO YOU SEE THAT THERE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: SHE SAYS, "SENT ALL PATIENTS TO SQ TO RETEST." DO YOU HAVE AN UNDERSTANDING OF WHAT SQ WOULD STAND FOR IN THIS CONTEXT?
ADAM ROSENDORFF: SONORA QUEST.
MR. BOSTIC: AND WHAT IS SONORA QUEST?
ADAM ROSENDORFF: IT IS THE CHAIN OF RETAIL COLLECTION SITES AND LABORATORIES IN ARIZONA.
MR. BOSTIC: WAS IT A COMPETITOR OF THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WAS IT A CONVENTIONAL LAB DISSIMILAR TO THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: THIS EMAIL INDICATES THAT WHEN THOSE PATIENTS WERE SENT TO SONORA QUEST TO RETEST, THEIR CALCIUM LEVELS CAME BACK AS NORMAL. DO YOU SEE THAT THERE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S ZOOM IN NOW ON THE TOP OF THE PAGE. AND WE'LL LOOK AT AN EMAIL FROM KIMBERLY ALFONSO TO CHRISTIAN HOLMES AND SUNNY BALWANI. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL SAYS, "CHRISTIAN - PLEASE SEE BELOW. ON #1, LET ME KNOW IF YOU WANT TO HAVE ERIC FURTHER DEFINE THE 5-6 PATIENTS AND THEIR RESULTS OR IF WE CAN LOOK UP BY PROVIDER." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S LOOK AT PAGE 1 OF THIS EXHIBIT. AND LET'S LOOK AT THE BOTTOM HALF AND CHRISTIAN HOLMES'S EMAIL ON SEPTEMBER 23RDRD. DO YOU SEE THAT EMAIL, DR. ROSENDORFF?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND ON SEPTEMBER 23RD, CHRISTIAN HOLMES WRITES AN EMAIL TO DANIEL YOUNG, INCLUDING SUNNY BALWANI, AND MAX FOSQUE. AT THE BOTTOM OF THAT EMAIL HE SAYS, "FOR MY OWN BACKGROUND, ARE THERE ANY FINDINGS WE CAN RELAY ABOUT HIGH TRENDS IN CALCIUM REPORTING? SEEMS TO BE BY FAR THE MAJORITY OF QUESTIONS WE GET ABOUT ACCURACY NOW." MY QUESTION FOR YOU IS AROUND THIS TIME IN SEPTEMBER OF 2014, WERE YOU ALSO SEEING ISSUES AROUND THE THERANOS CALCIUM TEST?
ADAM ROSENDORFF: I HAD SEEN ISSUES WITH HIGH CALCIUMS PRIOR TO THIS DATE.
MR. BOSTIC: AND SO YOU UNDERSTOOD THIS TO BE A PREEXISTING PROBLEM AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S ZOOM OUT AND ZOOM IN ON THE TOP HALF OF THIS PAGE, PLEASE. ARE YOU LOOKING NOW AT AN EMAIL FROM CHRISTIAN HOLMES TO ELIZABETH HOLMES SENT ON SEPTEMBER 23RD, 2010?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WERE YOU INCLUDED ON THIS EMAIL?
MR. BOSTIC: AND WAS MR. BALWANI INCLUDED ON THIS EMAIL?
MR. BOSTIC: THE SUBJECT LINE IS CUSTOMER ISSUE -- SIKORSKI. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE IMPORTANCE IS LISTED AS HIGH. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: MS. HOLMES'S BROTHER WRITES TO HER, HEY WANTED TO HAVE JUST A MORE CANDID CONVERSATION ABOUT THIS WITH YOU. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE SAYS, I AM ALWAYS CONFIDENT IN OUR TECHNOLOGY, BUT IT'S PRETTY OBVIOUS WE HAVE ISSUES WITH CALCIUM, POTASSIUM, AND SODIUM SPECIFICALLY. DO YOU AGREE WITH MR. HOLMES AT THAT TIME THAT THERANOS WAS HAVING PROBLEMS WITH ITS ASSAYS?
ADAM ROSENDORFF: I AGREE WITH HIS STATEMENT THAT THERE WERE PROBLEMS WITH THE ASSAYS. I DON'T AGREE WITH THE SPECIFICALLY PART.
MR. BOSTIC: CAN YOU EXPLAIN THAT? WHY WOULD YOU NOT USE THE WORD "SPECIFICALLY"?
ADAM ROSENDORFF: I THINK THERE WERE OTHER ASSAYS THAT HAD PROBLEMS.
MR. BOSTIC: INCLUDING SOME THAT WE HAVE BEEN SPEAKING ABOUT TODAY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: HOW ABOUT THE FIRST PART OF THAT SENTENCE WHERE CHRISTIAN HOLMES SAYS, "I AM ALWAYS CONFIDENT IN OUR TECHNOLOGY." IN SEPTEMBER OF 2014, WERE YOU CONFIDENT IN THE THERANOS TECHNOLOGY?
MR. BOSTIC: CHRISTIAN HOLMES GOES ON TO SAY IN HIS EMAIL, "SUNNY IS ON THESE EMAILS, BUT WANTED TO GET YOUR THOUGHTS SPECIFICALLY ON CONSIDERING TO STOP REPORTING THESE TESTS UNTIL WE FIND THE REASON WE ARE REPORTING AS WE ARE. I'M 1,000 PERCENT CONFIDENT THIS IS AN EASILY SOLVABLE ISSUE AND ONE THAT WE WILL FIX, BUT JUST MORE A QUESTION AROUND THE COST/BENEFIT OF CONTINUING TO SEND THESE RESULTS TO DOCS WHEN THERE SEEM TO BE ISSUES WITH THEIR ACCURACY." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID THIS REFLECT YOUR SENTIMENT AT THE TIME?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HOW ABOUT THE POINT ABOUT BEING 1,000 PERCENT CONFIDENT THIS IS AN EASILY SOLVABLE ISSUE. IS THAT HOW YOU FELT AT THERANOS?
ADAM ROSENDORFF: NO. I BELIEVED AT THAT TIME THAT THERE WERE INHERENT PROBLEMS IN RUNNING THESE KINDS OF ASSAYS RELIABLY FROM FINGERSTICK.
MR. BOSTIC: CHRISTIAN HOLMES RAISES THE QUESTION ABOUT THE COST/BENEFIT OF CONTINUING TO SEND THESE RESULTS TO DOCS WHEN THERE SEEMS TO BE ISSUES WITH THEIR ACCURACY. HOW WOULD YOU HAVE ASSESSED AT THE TIME THE COST/BENEFIT OF CONTINUING TO RELEASE THESE RESULTS TO PATIENTS AND DOCTORS?
MR. WADE: YOUR HONOR, I'M NOT SURE I UNDERSTAND THE RELEVANCE OF THIS INQUIRY COMMENTING ON AN EMAIL HE'S NOT ON. WE'RE PRETTY FAR AFIELD.
JUDGE DAVILA: ARE YOU ASKING HIS OPINION AS THE LAB DIRECTOR AT THE TIME?
MR. BOSTIC: I'M ASKING FOR HIS OPINION BASED ON WHAT HE SAW AT THE TIME. I'M ASKING HIM TO PROVIDE A SUMMARY OF WHAT HE HAD SEEN AT THE TIME, AND THIS IS ALSO RELEVANT TO EXPLAIN WHAT HE DID AFTER THIS TIME PERIOD.
JUDGE DAVILA: SUBSEQUENT CONDUCT?
MR. BOSTIC: CORRECT.
JUDGE DAVILA: SO WHY DON'T YOU ASK THOSE QUESTIONS IN THAT ORDER AND LAY THE FOUNDATION AND THE WITNESS CAN ANSWER.
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, AROUND THIS TIME, WERE YOU STILL THINKING ABOUT LEAVING THERANOS?
ADAM ROSENDORFF: YES, DEFINITELY.
MR. BOSTIC: WAS YOUR DECISION PROCESS BASED PARTLY ON YOUR VIEW OF THE RELIABILITY OF THE THERANOS ASSAYS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: MOVING ON TO THE THIRD PARAGRAPH IN CHRISTIAN HOLMES'S EMAIL. HE SAYS, "I AM ALSO BRINGING THIS UP BECAUSE I HAVEN'T HEARD ANY REASON/ROOT CAUSE FOR WHY THESE TESTS ARE OFF." CHRISTIAN HOMES WAS NOT A SCIENTIST; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND YOU WERE THE LAB DIRECTOR; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND AT THIS TIME, WERE YOU AWARE OF THE COMPANY HAVING DISCOVERED ANY REASON OR ROOT CAUSE FOR WHY THE TESTS WERE OFF?
ADAM ROSENDORFF: THERE WERE HYPOTHESES AND IDEAS BEING DISCUSSED. THERE WAS NO SINGLE ROOT CAUSE IDENTIFIED.
MR. BOSTIC: AND DID THAT FACT AFFECT YOUR OPTIMISM ABOUT WHETHER THE PROBLEMS COULD BE SOLVED?
ADAM ROSENDORFF: I DIDN'T BELIEVE AT THIS POINT THAT THERANOS COULD SOLVE THESE PROBLEMS.
MR. BOSTIC: CHRISTIAN HOLMES GOES ON TO SAY, "I JUST GET A RESPONSE FROM DANIEL THAT, 'WE ARE AWARE OF THE ISSUES AND ARE CONDUCTING A STUDY.'" HE SAYS, "LEAVES ME A BIT HANDS TIED WITH THE DOCS - OBVIOUSLY I CAN'T TELL THEM WE ARE WRONG, BUT THEY CONTINUE TO SEND PATIENTS TO QUEST AFTER WE REPORT HIGH, AND THE PATIENTS RESULTS COME BACK NORMAL." WHERE CHRISTIAN HOLMES SAYS THERE "OBVIOUSLY I CAN'T TELL THEM WE ARE WRONG," HOW DID THAT RELATE TO YOUR EXPERIENCE DISCUSSING THERANOS TEST RESULTS WITH DOCTORS?
ADAM ROSENDORFF: I CAME TO BELIEVE THAT THE THERANOS RESULTS WERE WRONG. IT CAUSED A LOT OF INNER CONFLICT. I HAD A DUTY AS A PHYSICIAN TO BE HONEST AND STRAIGHTFORWARD WITH THE PROVIDERS. I ALSO HAD OBLIGATIONS WITHIN THE COMPANY. I HAD A DUTY AS A LAB DIRECTOR TO BE TRANSPARENT WITH THE CLIENTS. AT ONE POINT I STARTED TO REFUSE TO TALK TO PHYSICIANS. I BELIEVE THAT I TOLD ONE OR TWO PHYSICIANS THAT I DIDN'T BELIEVE THE RESULTS. THAT CAUSED A LOT OF EMOTIONAL DISCOMFORT FOR ME.
MR. BOSTIC: AND DID YOU FEEL -- BASED ON YOUR, ON THE CONVERSATIONS THAT YOU HAD WITH MS. HOLMES AND MR. BALWANI, DID YOU FEEL THAT YOU WERE FREE CONSISTENTLY TO TELL DOCTORS WHEN TEST RESULTS WERE WRONG?
ADAM ROSENDORFF: NO. I FELT THAT ELIZABETH, SUNNY, AND CHRISTIAN, AND DANIEL TO SOME EXTENT, WERE PUSHING ME TO RATIONALIZE, JUSTIFY THE ERRONEOUS RESULTS TRY TO UNEARTH OR DIG UP PATIENT FACTORS THAT WOULD EXPLAIN ERRONEOUS RESULTS, ANYTHING OTHER THAN SAYING OUR TESTS ARE INACCURATE.
MR. BOSTIC: CHRISTIAN HOLMES GOES ON TO WRITE IN HIS EMAIL, "I KNOW HAVE SALES REPS, DOCS, AND PATIENTS WITHOUT ANSWERS AS TO WHY THEIR QUEST REPORT SAYS NORMAL, AND THERANOS'S DOESN'T. I'LL DEFINITELY MANAGE THESE THINGS, BUT JUST SEEMS TO BE WORTH CONSIDERING A HIATUS IN REPORTING THESE VALUES UNTIL WE HAVE FINISHED WHATEVER STUDIES DANIEL IS REFERRING TO." DID I READ THAT CORRECTLY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WOULD YOU ALSO HAVE SUPPORTED A HIATUS IN REPORTING THESE VALUES WHILE THE PROBLEM WAS INVESTIGATED?
ADAM ROSENDORFF: ABSOLUTELY.
MR. BOSTIC: YOUR HONOR, IF THE COURT PLANS TO BREAK FOR THE DAY AT 3:00 P.M., THIS WOULD BE A GOOD STOPPING POINT.
JUDGE DAVILA: YOU HAVE ADDITIONAL EXAMINATION?
MR. BOSTIC: YES, YOUR HONOR.
JUDGE DAVILA: LET'S DO THAT. LADIES AND GENTLEMEN, WE'LL BREAK FOR THE WEEKEND AT THIS TIME AND WE'LL RESUME ON TUESDAY NEXT AT 9:00 A.M. DOCTOR, YOU'LL COME BACK THEN TO RESUME YOUR EXAMINATION.
ADAM ROSENDORFF: YES, YOUR HONOR.
JUDGE DAVILA: THANK YOU. LADIES AND GENTLEMEN, A COUPLE OF THINGS. WHEN WE COME BACK NEXT WEEK, I HOPE YOU RECALL THAT I TOLD YOU I WOULD LIKE TO ROTATE YOU IN THE SEATING, AND I HOPE WHAT I CAN DO NEXT WEEK, WITH YOUR COOPERATION, IS PERHAPS MOVE OUR DEAR FRIENDS IN THE FRONT ROW TO THE BACK ROW, AND WE'LL ROTATE THOSE OF YOU WHO ARE SEATED OUTSIDE OF THE BOX, YOU'LL ROTATE INTO THOSE SEATS, AND THEN FOLKS WILL JUST MOVE DOWN AND WE'LL FOLLOW THAT EVERY WEEK. I HOPE THAT'S NOT TOO UNCOMFORTABLE FOR YOU. I WANT TO GIVE EVERYONE AN OPPORTUNITY TO ENJOY THESE LOVELY CHAIRS THAT EVERYONE IS SEATED IN IN THE JURY BOX. SO THAT'S WHAT WE'LL DO. WE'LL ROTATE THAT. I HOPE THAT DOESN'T CAUSE YOU TOO MUCH INCONVENIENCE. BEFORE WE BREAK, LET ME REMIND YOU AGAIN OF THE ADMONITION. PLEASE, PLEASE ENSURE THAT YOU, TO ALL EXTENT POSSIBLE, AVOID ANY MEDIA, SOCIAL MEDIA, INTERACTION WITH RADIO, TELEVISION, ANY SOCIAL MEDIA OR INTERNET. DO NOT DO ANY RESEARCH ON ANYTHING ABOUT THIS CASE OR ANYTHING TO DO WITH IT, INCLUDING RESEARCHING ANYTHING THAT YOU'VE HEARD TODAY OR ANY OF THE PARTIES INVOLVED IN THIS CASE. PLEASE AVOID DISCUSSING THIS CASE. YOU MUST NOT DISCUSS THE CASE AT ALL WITH EACH OTHER OR ANYONE AT YOUR HOMES OR WORKPLACES UNTIL THE CASE HAS BEEN DELIVERED TO YOU AND YOU CAN GO AND DO YOUR DELIBERATIONS. THAT'S THE ONLY TIME THAT YOU CAN BEGIN DISCUSSING THE FACTS OF THE CASE. SO I REMIND YOU OF THAT ADMONITION. I'M GOING TO ASK YOU THE QUESTION TUESDAY NEXT WHETHER OR NOT YOU HAVE INADVERTENTLY COME ACROSS ANYTHING ABOUT THE CASE. I APPRECIATE YOUR CONTINUED FIDELITY TO THIS ADMONITION, AND IT'S SO IMPORTANT AND THAT'S WHY I REMIND YOU OF THIS EACH TIME WE MEET. HAVE A GREAT WEEKEND. ENJOY THE WEEKEND. ANYTHING FURTHER, MS. KRATZMANN, FOR OUR JURY?
COURT CLERK: NO, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. GREAT. ANYTHING FURTHER, COUNSEL, BEFORE THE JURY LEAVES?
MR. DOWNEY: NO, YOUR HONOR.
MR. LEACH: NO, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. GREAT. HAVE A GREAT WEEKEND.
(JURY OUT AT 3:01 P.M.)
JUDGE DAVILA: ALL RIGHT. THANK YOU. PLEASE BE SEATED. THE RECORD SHOULD REFLECT THAT OUR JURY AND ALTERNATES HAVE LEFT FOR THE WEEKEND. BEFORE WE BREAK, COUNSEL, SHOULD WE JUST SCHEDULE A MEETING MONDAY MORNING AT SOME TIME? DOES THAT WORK?
MR. WADE: WE CAN CERTAINLY DO THAT. IF THE GOVERNMENT WANTS TO SUBMIT ITS PAPERS AND THEN WE CAN HAVE A REASONABLE TIME TO RESPOND IF IT WANTS TO EXCLUDE THAT EVIDENCE.
MR. BOSTIC: YOUR HONOR, I'M HAPPY TO SUBMIT SOMETHING IF THE COURT WOULD FIND THAT HELPFUL. IT'S DIFFICULT FOR US TO FRAME THAT ARGUMENT WITHOUT KNOWING EXACTLY WHERE THE DEFENSE INTENDS TO GO OR WHY. IN PARTICULAR, I HEARD MR. WADE TODAY TALK ABOUT BIAS, AND I JUST DON'T KNOW HOW BIAS IS RELEVANT HERE. SO I'M HAPPY TO ADDRESS THE ISSUE ORALLY WITH THE COURT, BUT I DEFER TO THE COURT ON WHAT WOULD BE MOST PRODUCTIVE.
JUDGE DAVILA: THANK YOU. WELL, MR. WADE, YOU WANTED TO WAIT UNTIL YOU HEARD TESTIMONY. DO YOU KNOW HOW MUCH ADDITIONAL EXAMINATION YOU HAVE, MR. BOSTIC?
MR. BOSTIC: WE'RE MUCH CLOSER TO THE END THAN THE BEGINNING, YOUR HONOR.
(LAUGHTER.)
JUDGE DAVILA: YOU KNOW, THEY SAY THAT ABOUT ME ALL OF THE TIME.
MR. BOSTIC: I WOULD SAY I HAVE APPROXIMATELY AN HOUR LEFT.
JUDGE DAVILA: FAIR ENOUGH.
MR. WADE: YOUR HONOR, I CAN GIVE IT SOME THOUGHT. I'M NOT SURE WE CAN ACCOMPLISH MUCH ON MONDAY. I AM ALWAYS HAPPY TO SEE THE COURT AND I KNOW YOU'LL MISS US IF WE'RE OFF AN EXTRA DAY. WE NEED TO ESTABLISH A FOUNDATION TO OFFER EVIDENCE FOR BIAS, AND TO THE EXTENT THAT WE INTEND TO DO THAT, WE'LL DO THAT AND THE COURT CAN RULE. WE WOULD MAYBE TRY TO DO IT AT A TIME -- I ANTICIPATE A LENGTHY CROSS-EXAMINATION. WE WOULD TRY TO DO IT AT A TIME AT OR AROUND WHEN WE COULD TAKE A BREAK IF NEEDED JUST TO TRY TO BE RESPECTFUL OF THE ISSUE. WE WANT TO GIVE THE GOVERNMENT EVERY OPPORTUNITY TO RAISE THEIR CONCERNS, BUT I'M NOT INCLINED TO LAY OUT MY CROSS-EXAMINATION WHILE THE WITNESS IS STILL ON DIRECT.
JUDGE DAVILA: NO. I UNDERSTAND THAT. I GUESS IT WOULD BE INAPPROPRIATE FOR ME TO ASK YOU, HAVE YOU HEARD ANYTHING THAT SUGGESTS A BIAS TYPE OF AN ISSUE?
JUDGE DAVILA: OKAY. FAIR ENOUGH. LET'S DO THIS: I'M GOING TO ASK YOU TO MEET AND CONFER ON THIS ISSUE. IF YOU FEEL THAT IT IS -- AFTER THAT, IF YOU FEEL THAT IT'S APPROPRIATE TO HAVE A DISCUSSION PRIOR TO MR. BOSTIC'S EXAMINATION ON TUESDAY, THEN WE HAVE THE MORNING AVAILABLE AND WE CAN OFFER THAT TO YOU, AND I WOULD INVITE YOU TO CONTACT MS. KRATZMANN FOR SCHEDULING.
MR. BOSTIC: WE WILL DO THAT.
JUDGE DAVILA: GREAT. EVERYONE HAVE A GOOD WEEKEND. ENJOY.
(COURT ADJOURNED AT 3:04 P.M.)