Adam Rosendorff — Direct/Cross (Continued)
2,694 linesDIRECT EXAMINATION (RESUMED) BY MR. BOSTIC:
MR. BOSTIC: GOOD MORNING, DR. ROSENDORFF. WELCOME BACK.
ADAM ROSENDORFF: GOOD MORNING.
MR. BOSTIC: DO YOU HAVE A BINDER OF DOCUMENTS IN FRONT OF YOU?
ADAM ROSENDORFF: YES.
MR. BOSTIC: I'D LIKE TO PICK UP WHERE WE LEFT OFF, PLEASE. IF YOU COULD TURN TO EXHIBIT 4182 IN THAT BINDER.
ADAM ROSENDORFF: I HAVE IT.
MR. BOSTIC: AND IS EXHIBIT 4182 AN EMAIL CHAIN INVOLVING INDIVIDUALS AT THERANOS, INCLUDING SUNNY BALWANI AND DANIEL YOUNG?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND I'LL LET YOU FLIP THROUGH THAT EMAIL CHAIN IF YOU WOULD LIKE, AND THEN I'LL ASK YOU, IS THAT EMAIL CHAIN RELATING TO A PARTICULAR LAB TEST RESULT GENERATED WITHIN THERANOS?
ADAM ROSENDORFF: YES. IT RELATES TO THE PT INR TEST.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES INTO EVIDENCE EXHIBIT 4182.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4182 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN START ON THE BOTTOM OF PAGE 3 PLEASE, AND IF WE CAN ZOOM IN TO CAPTURE THAT HEADER INFORMATION AT THE VERY BOTTOM, JUST THE LAST LINE OF THE PAGE.
JUDGE DAVILA: GIVE US JUST A SECOND, MR. BOSTIC. GREAT. I THINK WE'VE GOT IT. THANK YOU.
MR. BOSTIC: THANK YOU, YOUR HONOR.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE IN FRONT OF YOU THAT WE'RE ABOUT TO LOOK AT AN EMAIL IN FRONT OF YOU FROM AN INDIVIDUAL NAMED TRACEY MASSON?
ADAM ROSENDORFF: YES.
MR. BOSTIC: THANK YOU. MS. HOLLIMAN, IF WE COULD TURN TO PAGE 4, PLEASE. LET'S LOOK AT THE TOP EMAIL. DR. ROSENDORFF, DO YOU SEE THIS IS AN EMAIL FROM AUGUST 24TH, 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND SENT TO SUNNY BALWANI, CHRISTIAN HOLMES, AND OTHERS AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE THE SUBJECT IS BOT EXPERIENCE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE TEXT READS "COULD YOU PLEASE CHECK ON THESE RESULTS? THESE ARE FOR" NAME REDACTED "ONE OF OUR BOTS." IS BOT SHORT FOR PHLEBOTOMIST?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT IS A PHLEBOTOMIST?
ADAM ROSENDORFF: A PHLEBOTOMIST IS TRAINED TO DRAW BLOOD FROM A PATIENT.
MR. BOSTIC: LET'S ZOOM OUT. AND THEN ZOOM IN ON THE FIRST TWO PARAGRAPHS OF THE TEXT BELOW. DR. ROSENDORFF, DO YOU SEE THE TEXT BELOW REPORTS THIS EXPERIENCE FROM SOMEONE WHO BEEN ON ANTICOAGULANT FOR ABOUT 14 YEARS NOW? DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: IT GOES ON TO SAY, "I HAVE BEEN WITHIN RECOMMENDED PT INR RANGE FOR ABOUT 13 YEARS, PROMPTING THE SAME MG DOSAGE FOR OVER A DECADE." WHAT IS PT INR?
ADAM ROSENDORFF: IT'S A COAGULANT TEST. IT IS A TEST OF BLOOD CLOTTING. A NUMBER OF DIFFERENT CLINICAL CONDITIONS REQUIRE ANTICOAGULANT LONG-TERM, SUCH AS AFIB. THOSE PATIENTS WOULD BE ON COUMADIN AND THEY WOULD HAVE THEIR COAGULANT MONITORED WITH A PT INR.
MR. BOSTIC: AND THAT REPORT GOES ON TO READ, "I RECENTLY HAD MY STANDING ORDER SWITCHED TO THERANOS FOR MY PT INR MONITORING. THIS WAS THE FIRST TIME I HAD A CTN DRAW FOR MY PT INR." CAN YOU REMIND US WHAT CTN MEANS?
ADAM ROSENDORFF: IT'S CAPILLARY TUBE AND NANOTAINER.
MR. BOSTIC: AND YOU WERE GOING TO SAY IT WAS THE COLLECTION DEVICE?
ADAM ROSENDORFF: IT WAS THE COLLECTION DEVICE THAT THERANOS WAS USING FOR FINGERSTICK SAMPLES.
MR. BOSTIC: IS THIS A THERANOS-SPECIFIC DEVICE?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: THAT ACCOUNT GOES ON TO SAY "I WAS SURPRISED WHEN THE RESULTS CAME BACK OUT OF RANGE (TOO LOW). MY DOCTOR ADVISED ME TO RETEST ABOUT A WEEK LATER. THE SECOND CTN RESULT WAS ALSO EXTREMELY LOW AND HE INCREASED BY COUMADIN FOR ONE DOSE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: SHE THEN SAYS, "THIS WAS LAST WEEK. I HAVE NOT FELT RIGHT SINCE THE ONE INCREASED DOSE AND ALSO EXPERIENCED VARIOUS SKIN BRUISING ON MY LEGS AND ARMS ALMOST IMMEDIATELY AFTER THE ONE DOSE INCREASE. I ASKED FOR ANOTHER STANDING ORDER DRAW AT THE END OF MY SHIFT YESTERDAY. THIS TIME I WANTED THE DRAW SWITCHED FROM CTN TO VENOUS DRAW." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: LET'S ZOOM OUT, MS. HOLLIMAN, AND ZOOM BACK IN JUST ON THE LAST TWO LINES OF THIS PAGE. LOOKING AT THE BOTTOM OF THAT SCREEN, DO YOU SEE THAT, DR. ROSENDORFF? IT GOES ON TO SAY, "MY DOCTOR JUST CALLED ME BECAUSE MY PT INR RESULTS NOW SHOW THAT IT IS VERY HIGH."
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: AND MS. HOLLIMAN, LET'S GO TO THE NEXT PAGE, PAGE 5, AND ZOOM IN ON THE TEXT AT THE TOP. SHE THEN GOES ON TO SAY, "FOR TESTING ACCURACY, I WILL BE GETTING BOTH THE VENIPUNCTURE AND THE CTN DRAW ON MONDAY TO COMPARE RESULTS, AS THIS INFORMATION WOULD BE OF UTMOST IMPORTANCE TO THERANOS AND ULTIMATELY TO THE WELL-BEING OF OUR PATIENTS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: OKAY. WE CAN ZOOM OUT, MS. HOLLIMAN. DR. ROSENDORFF, AFTER SOME BACK AND FORTH IN THIS EMAIL, I'LL ASK YOU TO LOOK NOW AT THE BOTTOM HALF OF PAGE 1 OF THIS EXHIBIT. MS. HOLLIMAN, IF WE CAN GO THERE. DR. ROSENDORFF, DO YOU SEE IN THE BOTTOM OF THIS PAGE IN THE SAME EMAIL CHAIN THERE'S A MESSAGE FROM SUNNY BALWANI TO DANIEL YOUNG?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND ON AUGUST 24TH, 2014, MR. BALWANI WRITES, "DANIEL. THE NET NET OF THIS SEEMS TO SUGGEST THAT OUR PT WAS REPORTING RESULTS TOO LOW. CAN U PLZ TAKE A LOOK INTO THIS." DO YOU SEE THAT?
ADAM ROSENDORFF: I SEE THAT.
MR. BOSTIC: AND ABOVE THAT DANIEL RESPONDS, "AS I MENTIONED I HAD A FEW CONCERNS A FEW WEEKS BACK ABOUT SAMPLE STABILITY PT INR ONLY WHEN PATIENTS ARE UNDER COUMADIN TREATMENT. WE CREATED A STUDY PLAN TO EVALUATE THIS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: BASED ON YOUR EXPERIENCE AT THERANOS, ARE PATIENTS MONITORING PT INR LIKELY TO BE UNDER TREATMENT WITH COUMADIN?
ADAM ROSENDORFF: VERY LIKELY.
MR. BOSTIC: ABOVE THAT MESSAGE FROM DANIEL YOUNG, MR. BALWANI ASKS, "ARE THERE ANY OTHER ASSAYS YOU HAVE CONCERNS WITH, AND IF SO, PLEASE SEND ME A LIST." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: MS. HOLLIMAN, LET'S ZOOM IN ON THE TOP MESSAGE ON THIS PAGE. DR. ROSENDORFF, DO YOU SEE THAT DANIEL YOUNG RESPONDS ON AUGUST 25TH, 2014, TO PROVIDE THAT LIST OF ASSAYS THAT HE HAS CONCERNS WITH?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THAT LIST INCLUDES, BESIDES PT INR, HCG, TESTOSTERONE, VITAMIN B12, TSH/FT4, C02, AS WELL AS SOME REFERENCE TO GLUCOSE, POTASSIUM, AND BICARBONATE? DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: WHICH, IF ANY, OF THESE ASSAYS DO YOU RECALL HAVING ACCURACY ISSUES DURING YOUR TIME AT THE COMPANY?
ADAM ROSENDORFF: HCG, C02, GLUCOSE, POTASSIUM. I DON'T HAVE A DISTINCT RECOLLECTION ABOUT THE TSH/FT4, THE VITAMIN B12, OR THE TESTOSTERONE.
MR. BOSTIC: THOSE ARE THE ONES THAT COME TO MIND. IF I COULD ASK YOU TO TURN IN THAT ONE TAB IN YOUR BINDER TO EXHIBIT 4181, PLEASE.
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE THIS IS AN CONTINUATION OF THAT SAME EMAIL CHAIN?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WITH A COPY FROM SUNNY BALWANI TO ELIZABETH HOLMES?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4181.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4181 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN JUST ZOOM IN ON THE TOP HALF OF PAGE 1.
MR. BOSTIC: DR. ROSENDORFF, THIS IS IN THE SAME EMAIL CHAIN THAT WE WERE JUST LOOKING AT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU SEE AT THE TOP OF THE PAGE SUNNY BALWANI FORWARDS DANIEL YOUNG'S RESPONSE TO MS. HOLMES ON AUGUST 25TH, 2014?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND HIS COMMENT THERE IS "ALWAYS ANOTHER STUDY AFTER THE FACT." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHEN YOU WERE AT THERANOS, WERE YOU AWARE GENERALLY OF STUDIES PERFORMED WITHIN THE COMPANY TO ADDRESS ISSUES WITH ASSAYS BEING USED IN THE CLINICAL LAB?
ADAM ROSENDORFF: YES, THERE WERE FREQUENTLY STUDIES INITIATED AFTER PROBLEMS WERE IDENTIFIED TO RECHECK ACCURACY.
MR. BOSTIC: AND WE'VE TALKED ABOUT YOUR CONCERNS WITH ACCURACY DURING THAT TIME. DID YOU DRAW ANY COMFORT FROM THE FACT THAT THESE STUDIES WERE OCCURRING AT THERANOS?
ADAM ROSENDORFF: I THOUGHT THAT THEY WERE POTENTIALLY USEFUL. ONE CONCERN IS THAT THE STUDIES WOULD BE DONE UNDER OPTIMIZED CONDITIONS. STUDIES WERE FREQUENTLY DONE USING VENOUS BLOOD ONLY AND NOT VENOUS AND MATCHED FINGERPRICK, WHICH WOULD REDUCE THEIR POWER STUDIES.
MR. BOSTIC: AND GENERALLY SPEAKING, DID THE STUDIES THAT WE'RE TALKING ABOUT RESOLVE YOUR CONCERNS ABOUT THE ACCURACY OF THERANOS TESTS?
ADAM ROSENDORFF: NO, THEY DID NOT.
MR. BOSTIC: I'D LIKE YOU TO THINK BACK ON THE TESTIMONY THAT YOU'VE GIVEN FRIDAY AND TODAY ABOUT ISSUES OF THERANOS BLOOD TESTS. DO YOU HAVE THAT TESTIMONY IN MIND?
ADAM ROSENDORFF: YES.
MR. BOSTIC: HAVE OUR DISCUSSIONS COVERED EVERY INCIDENT INVOLVING ACCURATE PATIENT RESULTS THAT YOU OBSERVED AT THERANOS?
ADAM ROSENDORFF: I THINK OUR DISCUSSION HAS BEEN FAIRLY COMPREHENSIVE. NOTHING COMES TO MIND IMMEDIATELY ABOUT SOMETHING THAT WE HAVE OVERLOOKED, YEAH.
MR. BOSTIC: WHEN YOU WERE AT THE COMPANY, WHAT EFFECT DID THE INCIDENTS LIKE THE ONES WE'VE DISCUSSED HAVE ON YOUR VIEW OF THE TESTING ACCURACY AT THERANOS?
ADAM ROSENDORFF: EVERY TIME WE GOT A PHYSICIAN COMPLAINT OR QUERY, EVERY TIME OUR QC WOULD FAIL, EVERY TIME WE HAD A SPATE OF ANOMALOUS RESULTS OUT OF REFERENCE RANGE, IT RAISED SERIOUS OR GRAVE CONCERNS FOR ME ABOUT THE ACCURACY OF THE TESTING PROCESS.
MR. BOSTIC: LET'S SHIFT GEARS A LITTLE BIT. CAN YOU TELL ME, PLEASE, ARE YOU FAMILIAR WITH THE TERM CALLED PROFICIENCY TESTING?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT IS PROFICIENCY TESTING?
ADAM ROSENDORFF: PROFICIENCY TESTING IS A WAY OF CHECKING THE ACCURACY AND PRECISION OF YOUR TESTING PROCESS OVER AN EXTENDED PERIOD OF TIME. LABORATORIES SIGN UP WITH A PROFICIENCY TESTING ORGANIZATION, SUCH AS THE COLLEGE FOR AMERICAN PATHOLOGISTS, API, OR NEW YORK STATE PROFICIENCY, ET CETERA. THEY RECEIVE A CHALLENGE THREE TIMES A YEAR. EACH CHALLENGE CONSISTS OF A NUMBER OF SAMPLES. THE LABORATORY IS NOT AWARE OF THE CONCENTRATION OF ANALYTE IN THOSE SAMPLES. THEY THEN TEST THEM IN THE SAME WAY THEY WOULD TEST PATIENT SAMPLES AND THEY RECORD THE RESULTS TO THE ORGANIZATION THAT SENT THEM THE SAMPLES. THEY THEN RECEIVE AN EVALUATION THAT TELLS THEM HOW CLOSE THEIR RESULT IS TO THEIR PEERS. SO THE MEAN OF THEIR PEERS IS CONSIDERED TO BE THE TARGET VALUE, YEAH.
MR. BOSTIC: THANK YOU. WHAT IS THE RELATIONSHIP BETWEEN PROFICIENCY TESTING AND QUALITY CONTROL THAT WE'VE PREVIOUSLY DISCUSSED?
ADAM ROSENDORFF: PROFICIENCY TESTING OCCURS IN DISCRETE CHALLENGES OVER THE COURSE OF A YEAR. YOU'RE REQUIRED BY LAW TO DO PROFICIENCY TESTING. QUALITY CONTROL IS DONE, AS I MENTIONED, AT THE BEGINNING OF EACH DAY, OR AT THE BEGINNING OF EACH SHIFT.
MR. BOSTIC: AND WAS THERE A PROFICIENCY TESTING PROCESS IN PLACE AT THERANOS WHEN YOU WERE AT THE COMPANY?
ADAM ROSENDORFF: NO, THERE WAS NO FORMAL PROFICIENCY TESTING PROCESS.
MR. BOSTIC: HOW DID PROFICIENCY TESTING WORK AT THERANOS?
ADAM ROSENDORFF: ON OCCASION, AS I MENTIONED, THERE WERE QC STUDIES TO CHECK ACCURACY OF TESTING IF PROBLEMS WERE IDENTIFIED. I REPEATEDLY ALERTED MANAGEMENT TO THIS PROBLEM THAT WE DID NOT HAVE PROFICIENCY TESTING IN PLACE. WE STARTED TESTING IN SEPTEMBER AND IT WAS ALREADY OCTOBER AND WE HADN'T PERFORMED PROFICIENCY.
MR. BOSTIC: WHEN YOU SAY YOU RAISED THOSE CONCERNS TO MANAGEMENT, WHO SPECIFICALLY DID YOU SPEAK TO?
ADAM ROSENDORFF: THERE WAS A MEETING THAT WAS CONVENED IN MID 2014 SPECIFICALLY TO DISCUSS PROFICIENCY TESTING. EVERYBODY WAS AWARE THAT WE DID NOT HAVE A PROGRAM IN PLACE. DIFFERENT PROPOSALS WERE DISCUSSED AND VETTED AT THIS MEETING.
MR. BOSTIC: AND WHO WAS PRESENT AT THAT MEETING?
ADAM ROSENDORFF: ELIZABETH, SUNNY, DANIEL HOLMES -- I'M SORRY, DANIEL YOUNG, BRAD ARINGTON. HE WAS THE COUNSEL, THE CORPORATE COUNSEL. A NUMBER OF OTHER INDIVIDUALS THAT I DON'T RECALL.
MR. BOSTIC: AND WHAT DO YOU RECALL ABOUT THE CONTENT OF THAT MEETING? WHAT CONCERNS DID YOU RAISE AT THAT TIME?
ADAM ROSENDORFF: I RAISED THE CONCERN THAT WE DID NOT HAVE A PROFICIENCY PROGRAM IN PLACE. I EXPRESSED MY VIEW THAT IT WOULD NEED TO BE AN ALTERNATIVE ASSESSMENT OF PROFICIENCY BECAUSE THERANOS WAS DOING THE LABORATORY DEVELOPED TESTS WITHOUT PEERS, AND WE DISCUSSED DIFFERENT WAYS OF DOING THAT ALTERNATIVE ASSESSMENT OF PROFICIENCY.
MR. BOSTIC: AND WAS THERE A COLLECTIVE DECISION OR RESOLUTION REACHED AT THE END OF THAT MEETING?
ADAM ROSENDORFF: YES. I WAS TOLD -- I LEFT THE MEETING -- I LEFT THE MEETING STILL UNCOMFORTABLE. I FELT THAT MANAGEMENT WAS PAYING LIP SERVICE TO THIS ISSUE AND I DIDN'T FEEL LIKE I WOULD BE GIVEN THE RESOURCES AND SUPPORT BY MANAGEMENT TO EXECUTE ON THIS PROFICIENCY PROGRAM.
MR. BOSTIC: YOU MENTIONED THAT THAT MEETING WAS IN MID 2014; IS THAT CORRECT?
ADAM ROSENDORFF: THAT'S AS I RECALL, CORRECT.
MR. BOSTIC: AND HOW MUCH LONGER DID YOU STAY WITH THE COMPANY AFTER THAT MEETING?
ADAM ROSENDORFF: I LEFT IN NOVEMBER OF 2014.
MR. BOSTIC: AND IN THE INTERVENING MONTHS, WAS THERE ANY SIGNIFICANT PROGRESS MADE ON THE PROFICIENCY FRONT?
MR. BOSTIC: AND DID THERE COME A TIME WHEN THERANOS STAFF CONDUCTED PROFICIENCY TESTING OF EDISON TESTS COMPARED TO STANDARD COMMERCIAL ANALYZERS?
ADAM ROSENDORFF: YES. I BELIEVE -- I'M NOT SURE IF WE DISCUSSED DURING MY PREVIOUS TESTIMONY THAT LEFTOVER CAP SAMPLES WERE RUN ON BOTH THE IMMULITE AND THE EDISON FOR A NUMBER OF ANALYTES AND RESULTS WERE COMPARED AS A SPOT-CHECK OF ACCURACY. IT WAS NOT PART OF AN SOP. IT WAS NOT PART OF A FORMAL PROFICIENCY PROGRAM THAT WE HAD.
MR. BOSTIC: DO YOU RECALL WHOSE IDEA IT WAS TO CONDUCT THAT PROFICIENCY TESTING?
ADAM ROSENDORFF: MARK PANDORI, LANGLY GEE, AND MYSELF MET TO DISCUSS THE IDEA.
MR. BOSTIC: I'D LIKE TO SHOW YOU EXHIBIT 1548 AT THIS TIME. IT'S ALREADY IN EVIDENCE. MAY I PUBLISH IT, YOUR HONOR?
JUDGE DAVILA: YES.
MR. BOSTIC: IF WE CAN PLEASE GO TO THE ATTACHMENT TO THIS EMAIL, PLEASE, MS. HOLLIMAN, THE NATIVE.
MR. BOSTIC: DR. ROSENDORFF, IT WON'T BE IN THE BINDER, BUT ON THE SCREEN IN FRONT OF YOU, DO YOU HAVE SOME IMAGES OF SOME TESTING DATA?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND ARE THESE THE RESULTS FROM THE SPOT-CHECK PROFICIENCY TESTING THAT WE'VE BEEN DISCUSSING?
ADAM ROSENDORFF: YES.
MR. BOSTIC: DO YOU SEE IN THIS DATA THAT THERE ARE GROUPS OF RESULTS FOR VITAMIN D, TPSA, FT4, AND TSH; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND EACH ONE OF THOSE HAS A ROW LABELLED PREDICATE AND ONE LABELED THERANOS. CAN YOU EXPLAIN WHAT THOSE TWO ROWS SIGNIFY?
ADAM ROSENDORFF: THE PREDICATE ROW OF THE RESULTS OBTAINED FOR THE SET OF PROFICIENCY SAMPLES ON THE IMMULITE INSTRUMENT, THE THERANOS ROW INDICATES THE RESULTS OBTAINED USING THE EDISON INSTRUMENT, AND THEN THE THIRD ROW IS A RATIO BETWEEN THE THERANOS RESULT AND THE PREDICATE RESULTS. A 100 PERCENT RECOVERY WOULD INDICATE AN IDENTICAL RESULT. ANYTHING HIGHER THAN 100 WOULD SHOW THAT THE THERANOS METHOD WAS TESTING HIGHER THAN THE PREDICATE METHOD.
MR. BOSTIC: AND WHAT WAS THE POINT, GENERALLY SPEAKING, OF INCLUDING THE PREDICATE METHOD OF THE NON-THERANOS ANALYZER IN THIS TEST?
ADAM ROSENDORFF: WELL, THE ASSAY HAD BEEN VALIDATED AGAINST THE IMMULITE, SO FOR THIS EXERCISE IT WAS AN APPROPRIATE CHOICE OF COMPARATORY METHOD.
MR. BOSTIC: AND IN RUNNING A TEST LIKE THIS, WHAT CONSTITUTES GOOD PERFORMANCE? WHAT ARE YOU HOPING TO SEE WHEN YOU LOOK AT THESE RESULTS?
ADAM ROSENDORFF: WELL, PROFICIENCY -- THE ALTERNATIVE ACCEPTANCE OF PROFICIENCY -- IN AN ALTERNATIVE ACCEPTANCE OF PROFICIENCY, THE ACCEPTANCE CRITERIA FOR HOW CLOSELY THE RESULTS SHOULD MATCH ARE DEFINED IN THE SOP. IN GENERAL, I WOULD HAVE SET 20 PERCENT DIFFERENCE AS ACCEPTABLE PERFORMANCE.
MR. BOSTIC: AND WHEN YOU SAY 20 PERCENT DIFFERENCE, ARE YOU TALKING ABOUT THE CLOSENESS OF THE MATCH BETWEEN THE THERANOS RESULTS AND THE PREDICATE RESULTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: GENERALLY SPEAKING -- AND YOU CAN TAKE A MOMENT TO LOOK AT THE DATA IF YOU WOULD LIKE -- GENERALLY SPEAKING, DID THERANOS PERFORM WELL IN THIS COMPARISON TEST AGAINST THE PREDICATE?
ADAM ROSENDORFF: SO THE ONLY ANALYTE THAT I CAN SEE THAT IS WITHIN THAT 20 PERCENT WOULD BE TSH. THE VITAMIN 2 THERANOS TESTS RETURNED A RESULT THAT WAS MORE THAN DOUBLED THE PREDICATE FOR ALL OF THE SAMPLES, THE NEW YORK STATE SAMPLES. THERE IS BOTH UNDER RECOVERY AND OVER RECOVERY FOR TPSA AND FREE T4.
MR. BOSTIC: AND FOR TSH SPECIFICALLY, DO YOU SEE IN COLUMN I THERE'S A SET OF RESULTS WHERE THE PREDICATE TESTED AT LEVEL OF 10.2 AND THERANOS TESTED AT 35.52?
ADAM ROSENDORFF: YES. I OVERLOOKED THAT DATA POINT. SO THAT WOULD BE -- SO IN PROFICIENCY TESTING, HOW MOST PEOPLE DO IT IS THAT YOU LOOK AT FIVE SAMPLES ACROSS A RANGE OF VALUES AND THE PASSING CRITERIA IS THAT FOUR OUT OF FIVE SHOULD PASS.
MR. BOSTIC: OKAY. UNDERSTOOD. GENERALLY SPEAKING, WERE PEOPLE AT THERANOS PLEASED WITH THE EDISON'S PERFORMANCE ON THIS TEST, IF YOU KNOW?
ADAM ROSENDORFF: ON TSH?
MR. BOSTIC: ACROSS THE BOARD ON THIS PROFICIENCY TEST.
ADAM ROSENDORFF: THE GROUP WHO CAME UP WITH THE PLAN WAS NOT AS CONCERNED, AND THEN THE NEWS OF THIS EXERCISE LEAKED OUT TO OTHERS WITHIN THE COMPANY.
MR. BOSTIC: I'LL ASK YOU TO TURN IN YOUR BINDER TO EXHIBIT 1580, PLEASE. YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT THIS. I UNDERSTAND THE DEFENSE HAS STIPULATED TO THIS.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1580 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: THANK YOU. MS. HOLLIMAN, IF WE CAN GO TO PAGE 5, PLEASE. IF YOU CAN ZOOM IN ON JUST THE MIDDLE OF THE PAGE.
MR. BOSTIC: DR. ROSENDORFF, FIRST, DO YOU SEE AN EMAIL FROM DANIEL YOUNG TO YOU, ELIZABETH HOLMES, AND SUNNY BALWANI?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND DO YOU SEE GENERALLY THAT EMAIL DISCUSSES PROFICIENCY TESTING?
ADAM ROSENDORFF: YES.
MR. BOSTIC: THANK YOU, MS. HOLLIMAN. LET'S GO TO PAGE 4 IN THIS EXHIBIT. LET'S ZOOM IN ON THE TOP HALF OF THIS PAGE, PLEASE. DR. ROSENDORFF, DO YOU SEE IN THE MIDDLE OF THAT IMAGE AN EMAIL FROM LANGLY GEE TO YOU, DANIEL YOUNG, AND MARK PANDORI?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE TEXT SAYS, "ATTACHED IS DATA I HAVE COLLECTED ON OUR PAST API AND NY PROFICIENCIES THAT COMPARES PREDICATE VERSUS EDISON ON VITAMIN D." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: I AM SORRY. IT SAYS VITAMIN D, TSH, FT4, AND PSA; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND LET'S GO TO PAGE 3 IN THIS EXHIBIT. LET'S LOOK AT THE BOTTOM HALF OF THIS PAGE, PLEASE. DR. ROSENDORFF, DO YOU SEE A MESSAGE WHERE SUNNY BALWANI SAYS, "WHERE AND WHO PULLED THE RESULTS FOR EDISON RUNS?"
ADAM ROSENDORFF: YEAH.
MR. BOSTIC: HE SAYS "I WOULD LIKE TO SEE THE RAW DATA FOR THESE AND MAKE SURE THE CALIBRATIONS, ET CETERA, WERE PROPERLY APPLIED." DO YOU SEE THAT?
ADAM ROSENDORFF: I SEE THAT.
MR. BOSTIC: LET'S ZOOM IN, PLEASE, ON THE TOP HALF OF THIS PAGE NOW. DO YOU SEE DISCUSSION IN THIS SECTION ABOUT HOW THE EDISON ASSAYS WERE VALIDATED?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: CAN YOU EXPLAIN WHAT THAT MEANS, IN PARTICULAR YOUR MESSAGE AT THE TOP WHERE IT SAYS, "THEY WERE VALIDATED ON THE IMMULITE FOR THE MOST PART"?
ADAM ROSENDORFF: THE ACCURACY OF A LABORATORY TEST, IN THIS CASE THE THERANOS EDISON TESTS WERE PERFORMED USING A VENOUS PLUG. THE SAME SAMPLE WOULD BE TESTED ON THE IMMULITE AND ON THE EDISON, AND THAT'S HOW YOU WOULD DETERMINE THE ACCURACY, YEAH.
MR. BOSTIC: SO, IN OTHER WORDS, THE IMMULITE WAS USED AS THE STANDARD FOR THE VALUATION OF THESE EDISON ASSAYS?
ADAM ROSENDORFF: CORRECT. IT'S ALSO KNOWN AS THE COMPARATOR ASSAY.
MR. BOSTIC: LET'S GO TO PAGE 2 OF THIS EXHIBIT, PLEASE. LET'S LOOK AT THE BOTTOM MESSAGE. DR. ROSENDORFF, DO YOU SEE THAT SUNNY BALWANI WRITES YOU AND OTHERS TO SAY, "AND OUR VALIDATION AGAINST IMMULITE HAS BEEN EXCELLENT IN THE PAST. IT IS THESE PT SAMPLES THAT ARE OFF"?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: DO YOU REMEMBER THIS EXCHANGE AT THE TIME AND MR. BALWANI SAYING IT MUST BE THE PT SAMPLES THAT ARE OFF?
ADAM ROSENDORFF: YES, I REMEMBER IT VERY, VERY WELL.
MR. BOSTIC: DID YOU AGREE THAT IT WAS THE PT SAMPLES THEMSELVES THAT WERE THE PROBLEM HERE?
ADAM ROSENDORFF: NO, I DID NOT.
MR. BOSTIC: AND WHY NOT?
ADAM ROSENDORFF: PT SAMPLES MUST BE DISTRIBUTED TO PARTICIPATING LABORATORIES OVER AN EXTENDED TIME PERIOD. THEY MUST SURVIVE SHIPPING CONDITIONS. THEY MUST BE STABLE TO FREEZE/THAW. IN VIEW OF THESE CONSIDERATIONS, THEY'RE MADE OUT TO BE VERY STABLE, THEY HAVE PRESERVATIVES TO PREVENT BACTERIA GROWTH, AND THEY HAVE BUFFERS TO PREVENT PH CHANGES, AND PROTEINS TO MAINTAIN THE OSMOTIC PRESSURE, ET CETERA.
MR. BOSTIC: AND --
ADAM ROSENDORFF: THAT ARE TO BE STABLE.
MR. BOSTIC: AND BASED ON YOUR EXPERIENCE IN WORKING WITH PT SAMPLES, HAVE THEY PERFORMED AS INTENDED?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S ZOOM OUT AND ZOOM BACK IN ON THE TOP OF THIS PAGE, PLEASE, THE VERY TOP. DO YOU SEE AT THE TOP OF THE PAGE A MESSAGE "CC'ING ELIZABETH ON THIS AS WE WENT THRU THESE DISCUSSION OVER A YEAR AGO ALSO"?
ADAM ROSENDORFF: THIS MESSAGE IS FROM SUNNY BALWANI.
MR. BOSTIC: YOU SEE THAT ON THE EXHIBIT?
ADAM ROSENDORFF: ON PAGE 1 AT THE VERY BOTTOM OF THE PREVIOUS PAGE IT SAYS FROM SUNNY BALWANI.
MR. BOSTIC: OKAY. AND DO YOU SEE THAT ON THE SCREEN?
ADAM ROSENDORFF: NO. I'M LOOKING AT THAT IN MY BINDER.
MR. BOSTIC: LET'S GO TO PAGE 1 OF THIS EXHIBIT NOW. AND LET'S ZOOM IN ON THE BOTTOM HALF OF THE PAGE MOVING FORWARD IN TIME HERE. NOW LET'S CAPTURE THE BOTTOM HALF OF PAGE 1. DR. ROSENDORFF, DO YOU SEE A MESSAGE FROM YOURSELF IN THIS CHAIN STATING IF WE DID ENROLL FOR PT FOR THERANOS METHODS, WE WOULD NEED TO DO AN ALTERNATE ASSESSMENT PROTOCOL OR AAP?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WE'RE NOW IN FEBRUARY 2014. WAS THIS THE FIRST TIME THAT YOU HAD RAISED THE NEED FOR AAP PROFICIENCY TESTING AT THERANOS?
ADAM ROSENDORFF: NO. I RAISED THE ISSUE WITH DANIEL YOUNG AND DISCUSSED IT WITH HIM PRIOR TO THIS.
MR. BOSTIC: ABOVE YOUR EMAIL THERE'S A MESSAGE FROM ELIZABETH HOLMES. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: SHE SAYS, "WE ENGAGED TOP COUNSEL ON THIS SOME TIME AGO. SUNNY WILL DEBRIEF YOU TOMORROW -- IT IS CRITICAL THAT NO ONE IS GUESSING ON MATTERS LIKE THESE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND IS THAT WHAT YOU WERE DOING, YOU WERE GUESSING?
ADAM ROSENDORFF: NO, I WAS NOT. I WAS READING THROUGH THE REGULATIONS, DECIDING WHAT WAS MOST APPROPRIATE FOR PATIENT CARE IN TERMS OF VERIFYING ACCURACY AND GIVING MY GUIDANCE.
MR. BOSTIC: AND HOW DID WHAT YOU WERE DOING FIT IN, IF IT DID AT ALL, WITH THE ROLE OF LABORATORY DIRECTOR?
ADAM ROSENDORFF: THE LABORATORY DIRECTOR WAS RESPONSIBLE AT THE END OF THE DAY FOR THE ACCURACY OF TESTS THAT GO OUT IN THE LAB.
MR. BOSTIC: AND DID THAT INCLUDE ESTABLISHING APPROPRIATE PROFICIENCY TESTING AT THE LAB?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S GO NOW TO THE TOP HALF OF PAGE 1. DR. ROSENDORFF, DO YOU SEE A MESSAGE HERE FROM SUNNY BALWANI TO YOU AND OTHERS, INCLUDING ELIZABETH HOLMES, AT THERANOS?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND HE SAYS AT THE TOP OF HIS EMAIL "I ALSO WANT TO REITERATE THIS POINT. I AM EXTREMELY IRRITATED AND FRUSTRATED BY FOLKS WITH NO LEGAL BACKGROUND TAKING LEGAL POSITIONS AND INTERPRETATIONS ON THESE MATTERS AND JUNIOR CLIA AND NON-CLIA PERSONNEL CHALLENGING OUR CLIA SOP'S. THIS MUST STOP," HE SAYS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND IN THE SECOND PARAGRAPH OF THE EMAIL HE SAYS, "THESE PAST FEW DAYS, WE HAVE WASTED SO MUCH TIME TALKING TO PEOPLE OUTSIDE OF CLIA WHO HAVE COME TO US TO SHARE THAT OUR PT ON VITAMIN D ON EDISON HAS FAILED. THESE PT SAMPLES SHOULD HAVE NEVER RUN ON EDISONS TO BEGIN WITH." DID YOU FEEL AT THIS TIME THAT THE PT TESTS THAT HAD BEEN RUN WERE A WASTE OF TIME?
ADAM ROSENDORFF: NO. LABORATORIES FREQUENTLY ENGAGE IN QC EXERCISES THAT ARE DOCUMENTED. MY PREFERENCE AND WHAT IS THE MOST COMMON PRACTICE IS TO SIDE ON AN SOP -- A VALIDATION PLAN FOR DOING PROFICIENCY TO WRITE A STANDARD OPERATING PROCEDURE WHICH INCLUDES ACCEPTANCE CRITERIA FOR THE RESULTS OF THE PROFICIENCY TESTING EXERCISE, AND TO RECORD THIS AS A -- TO HAVE THAT BE SIGNED OFF BY THE LABORATORY DIRECTOR, AND THAT NEEDS TO BE IN CONTROLLED DOCUMENTS SO THAT ANY CHANGES HAVE A DATE AND SIGNATURE ASSOCIATED WITH IT.
MR. BOSTIC: IN THE LAST HALF, OR THE LAST PARAGRAPH OF MR. BALWANI'S EMAIL, HE SAYS IN THE MIDDLE OF THAT PARAGRAPH, "NO PERSONAL OPINIONS. RIGHT NOW, EVERY CLS OR TS OR GS CONSIDERS THEMSELVES AS REGULATORY EXPERT AND THIS CULTURE MUST BE NIP IN THE BUD." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU AGREE WITH THOSE COMMENTS?
ADAM ROSENDORFF: I WAS HIRED TO APPLY MY EXPERTISE AND OPINIONS TO THE DIRECTION OF THE LABORATORY. I ALSO DELEGATED THE PROFICIENCY TESTING TO THE TECHNICAL SUPERVISOR, SO IT'S NOT REALLY AN APPROPRIATE STATEMENT.
MR. BOSTIC: I'LL ASK YOU TO TURN TO EXHIBIT 1724, PLEASE, IN YOUR BINDER. DO YOU HAVE THAT? LET ME KNOW IF YOU RECOGNIZE IT.
ADAM ROSENDORFF: I HAVE IT.
MR. BOSTIC: AND IS EXHIBIT 1724 AN EMAIL FROM YOU TO CHIN MAY PANGARKAR?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1724. I WAS THE DEFENSE HAS STIPULATED?
JUDGE DAVILA: IT'S ADMITTED AND MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1724 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, IS THIS AN EMAIL FROM MAY 13TH, 2014?
ADAM ROSENDORFF: YES, IT IS.
MR. BOSTIC: AND SO MONTHS LATER THAN WHAT WE HAVE BEEN LOOKING AT; IS THAT CORRECT?
ADAM ROSENDORFF: I'M SORRY. CAN YOU REMIND ME OF THE DATE OF THE PREVIOUS EXHIBIT?
MR. BOSTIC: YES. YOU CAN FLIP BACK TO EXHIBIT 1758 IF YOU NEED TO TO REFRESH YOUR RECOLLECTION.
ADAM ROSENDORFF: THOSE DISCUSSIONS WERE IN FEBRUARY OF 2014, AND MY REQUESTS FOR AN UPDATE FROM CHIN MAY WERE IN MAY 2014.
MR. BOSTIC: THIS EMAIL WHERE YOU ASKED FOR AN UPDATE, IS THIS REFERRING TO THE SAME PROFICIENCY TESTING CONCERNS THAT YOU HAD RAISED PREVIOUSLY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HAD ANY PROGRESS BEEN MADE ON GETTING PROFICIENCY TESTING UP AND RUNNING AT THERANOS IN THE MONTHS BETWEEN THE TWO EMAILS?
MR. BOSTIC: AND WAS THAT FOR LACK OF EFFORT ON YOUR PART?
MR. BOSTIC: WHAT WAS THE REASON, IF YOU UNDERSTOOD IT, WHY PROFICIENCY TESTING STILL WASN'T HAPPENING?
ADAM ROSENDORFF: A PLAN HAD BEEN DRAFTED BY MYSELF MANY MONTHS BEFORE THIS. I SIGNED UP ON THAT PLAN, I HAD DISCUSSIONS WITH MANAGEMENT ABOUT THE NEED TO EXECUTE ON THAT PLAN, AND RESOURCES AND THE MANAGEMENT DIRECTION WERE NEEDED TO ACTUALLY EXECUTE ON THE PLAN. I HAD DONE EVERYTHING I COULD FROM THE LAB DIRECTOR PERSPECTIVE.
MR. BOSTIC: AT THE TOP OF THIS PAGE IN THE HEADER INFORMATION, THERE'S A BCC TO A. ROSENDORFF AT GMAIL.COM. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID YOU BCC YOUR PERSONAL EMAIL IN THIS MESSAGE?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WAS THE PURPOSE OF THAT?
ADAM ROSENDORFF: AS I MENTIONED BEFORE, I WANTED TO PROTECT MYSELF IN THE EVENT OF A GOVERNMENTAL OR CMS INVESTIGATION. I WAS CONSIDERING FILING A QUI TAM OR FALSE CLAIMS LAWSUIT AGAINST THE COMPANY AND I ALSO -- I WANTED TO GET THE WORD OUT ABOUT WHAT WAS HAPPENING AT THERANOS.
MR. BOSTIC: AND THAT INCLUDED PROFICIENCY TESTING?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S TALK ABOUT TRANSPARENCY AT THERANOS. FIRST, LET'S LOOK AT EXHIBIT 1248, PLEASE. YOU TESTIFIED BEFORE THAT PART OF THE LAB DIRECTOR ROLE WAS SPEAKING TO PATIENTS AND DOCTORS ABOUT INDIVIDUAL TEST RESULTS. DO YOU REMEMBER THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: IN THOSE CONVERSATIONS, DID YOU FEEL THAT YOU WERE ABLE TO BE OPEN AND TRANSPARENT WITH DOCTORS AND PATIENTS ABOUT ISSUES WITH THERANOS TESTS?
ADAM ROSENDORFF: I FELT A CONFLICT BETWEEN THE MESSAGING THAT THE COMPANY WANTED ME TO PROVIDE AND THEIR DIRECTION TO EXPLORE JUSTIFICATIONS FOR ERRONEOUS RESULTS AND MY DUTY AS A PHYSICIAN TO INFORM THEM OF MY CONCERNS REGARDING THE ACCURACY OF THE TESTING.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 1248 NOW. YOUR HONOR, THE GOVERNMENT MOVES IT INTO EVIDENCE. I UNDERSTAND IT'S SUBJECT TO STIPULATION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1248 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: IF WE CAN ZOOM IN ON THE TOP HALF OF THE PAGE.
MR. BOSTIC: DR. ROSENDORFF, YOU'RE NOT ON THIS EMAIL CHAIN; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND THIS IS AN EMAIL FROM DANIEL YOUNG TO SUNNY BALWANI AND ELIZABETH HOLMES IN NOVEMBER OF 2013; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IT SAYS, "QUICK SUMMARY OF MEETING WITH SHARADA, RAN, ADAM, AND SURAJ." ARE YOU THE ADAM IN THAT LIST?
ADAM ROSENDORFF: YES. THERE WAS ONLY ONE OTHER ADAM AT THE COMPANY AND I DON'T THINK THIS REFERS TO HIM.
MR. BOSTIC: UNDER THE BULLET POINTS THERE IN DANIEL YOUNG'S EMAIL, THE SECOND ONE IS FOR TSH. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE FIRST BULLET UNDER THAT SAYS, "WE DISCUSSED THE CURRENT LLOQ FOR TSH WHICH IS.1." WHAT IS LLOQ?
ADAM ROSENDORFF: IT IS THE LOWER LIMITS OF QUANTITATION. IT IS THE LOWEST CONCENTRATION OF ANALYTES THAT CAN BE MEASURED WITH AN ACCEPTABLE PRECISION AND ACCURACY.
MR. BOSTIC: SO IS IT A MEASURE OF HOW SENSITIVE A GIVEN ASSAY IS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND THE SECOND BULLET POINT SAYS, "ADAM NOTED THAT SOME ASSAYS THIRD AND FOURTH GENERATION ASSAYS ON THE MARKET HAVE LOWER LLOQ." WOULD THAT MEAN A HIGHER SENSITIVITY?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND THE THIRD BULLET POINT SAYS, "ADAM WANTED TO ADD A NOTE ON THE LAB RESULTS INDICATING THAT OUR ASSAY IS SECOND GENERATION. I TOLD HIM THIS IS NOT WHAT WE WERE GOING TO DO." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND WHY DID YOU WANT TO INDICATE A NOTE THAT THE THERANOS TEST WAS SECOND GENERATION AS OPPOSED TO THIRD OR FOURTH GENERATION?
ADAM ROSENDORFF: IT'S IMPORTANT FOR PHYSICIANS TO KNOW HOW SENSITIVE THE TSH IS. IT'S ESSENTIALLY FOR DISTINGUISHING MILD HYPERTHYROIDISM FROM SEVERE HYPERTHYROIDISM, SO THYROID TOXICOSIS.
MR. BOSTIC: THE HEADER OF THIS EMAIL TELLS US THAT THIS EMAIL WAS SENT TO SUNNY BALWANI AND ELIZABETH HOLMES; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WAS THIS POLICY EVER CHANGED AT THERANOS? WERE YOU EVER PERMITTED TO INCLUDE THAT NOTE ON LAB TESTS FOR TSH?
ADAM ROSENDORFF: NO, I WAS NOT.
MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 4146, PLEASE. YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4146. I BELIEVE THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: IT'S ADMITTED AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4146 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S START WITH PAGE 3, PLEASE, ON THE BOTTOM HALF.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE THIS EMAIL CHAIN STARTS WITH A MESSAGE EMAIL FROM GURBIR SIDHU AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND MR. SIDHU SAYS, "HI ADAM, I HAVE SUBMITTED REQUEST FOR REDRAW FOR CBC AND ESR ON PATIENT," AND THEN REDACTED, "DUE TO COMPROMISED INTEGRITY." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND ABOVE IT SAYS APPROVED.
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT WERE YOU APPROVING HERE?
ADAM ROSENDORFF: THE REDRAW FOR THIS PATIENT FOR CBC AND ESR.
MR. BOSTIC: AND WHY WAS A REDRAW NECESSARY IN THIS CASE?
ADAM ROSENDORFF: I HAD BEEN INFORMED BY A CLINICAL LABORATORY SCIENTIST WHO WAS QUALIFIED TO MAKE THE DETERMINATION AS TO SAMPLE INTEGRITY, AND HE HAD INFORMED ME THAT THE SAMPLE INTEGRITY WAS COMPROMISED. I APPROVED THE REDRAW.
MR. BOSTIC: DO YOU HAVE AN UNDERSTANDING OF WHAT EQUIPMENT WAS USED AT THERANOS TO RUN, FOR EXAMPLE, THE CBC TEST AT THIS TIME?
ADAM ROSENDORFF: YES. WHOLE BLOOD WOULD BE MIXED WITH ANTIBODIES SPECIFIC FOR EACH CELL TYPE IN THE WHOLE BLOOD. A SECONDARY ANTIBODY WOULD BE APPLIED, CONJUGATED TO A FLUOROPHORE, AND THIS WOULD BE RAN ON A COMMERCIALLY AVAILABLE FLOW CYTOMETRY INSTRUMENT.
MR. BOSTIC: AND FOR FINGERSTICK SAMPLES, WAS THAT COMMERCIALLY AVAILABLE ANALYZER MODIFIED BY THERANOS?
ADAM ROSENDORFF: NOT TO MY KNOWLEDGE. I JUST WANT TO ADD THAT IT WAS A -- IT'S A RESEARCH INSTRUMENT. I MEAN, ANY TEST RUN ON THE ANALYZER WOULD HAVE TO BE A LABORATORY DEVELOPED TEST.
MR. BOSTIC: UNDERSTOOD. SO THIS WOULD BE, IN OTHER WORDS, A THERANOS SPECIFIC TEST AND NOT AN FDA APPROVED TEST?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND LET'S LOOK AT PAGE 2 IN THIS EMAIL, PLEASE. LET'S ZOOM IN ON THE BOTTOM HALF. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM SOMEONE NAMED ANAM KHAN TO CHRISTIAN HOLMES ON MAY 29TH IN, 2014?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND IT SAYS, "HI, CHRISTIAN, CAN YOU PLEASE APPROVE THIS REDRAW? THANKS ANAM."
ADAM ROSENDORFF: I SEE THAT.
MR. BOSTIC: ARE YOU AWARE OF ANY ROLE THAT CHRISTIAN HOLMES HAD AT THE COMPANY IN APPROVING REDRAWS?
ADAM ROSENDORFF: I WASN'T AWARE AT ALL THAT HE WAS INVOLVED IN THAT KIND OF A DECISION.
MR. BOSTIC: AND DID HE HAVE ANY POSITION IN THE CLINICAL LAB AT THERANOS ITSELF?
ADAM ROSENDORFF: NO. SO ANYBODY MAKING A CLINICAL DECISION HAS TO BE ON THE CMS ROSTER, IT'S FORM 209. IT LISTS ALL OF THE PERSONNEL THAT ARE HANDLING PATIENT SPECIMENS, MAKING DECISIONS SUCH AS THESE, ET CETERA.
MR. BOSTIC: DID CHRISTIAN HOLMES HAVE A MEDICAL OR A SCIENCE BACKGROUND TO YOUR KNOWLEDGE?
ADAM ROSENDORFF: NO, HE DID NOT.
MR. BOSTIC: WHEN YOU WERE LAB DIRECTOR AT THE COMPANY, WERE YOU AWARE THAT IN SOME CASES CHRISTIAN HOLMES WOULD BE ASKED TO APPROVE REDRAWS?
ADAM ROSENDORFF: I WAS NOT AWARE.
MR. BOSTIC: LET'S ZOOM OUT, MS. HOLLIMAN, AND CAPTURE THE EMAIL MESSAGE JUST ABOVE THAT. ACTUALLY, LET'S GO DOWN TO THE MESSAGE JUST BELOW THAT ONE. DO YOU SEE THAT, DR. ROSENDORFF, THAT CHRISTIAN HOLMES EMAILS DANIEL EDLIN AND ELIZABETH HOLMES AND IT SAYS, "DANIEL - PLEASE SEE NOTES BELOW. FROM WHAT IT SEEMS A REDRAW IS NECESSARY GIVEN THE DISINTEGRATION OF CELLS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: AND LET'S GO TO THE MESSAGE ABOVE. AND HERE CHRISTIAN HOLMES INDICATES THAT MESSAGE SHOULD HAVE GONE TO DANIEL YOUNG INSTEAD OF DANIEL EDLIN. DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: LET'S GO TO PAGE 1 OF THIS EMAIL, PLEASE. AND LET'S ZOOM IN ON THE BOTTOM HALF. DR. ROSENDORFF, DO YOU SEE AT BOTTOM OF THE SCREEN THERE'S A MESSAGE FROM CHRISTIAN HOLMES TO ELIZABETH HOLMES AND DANIEL YOUNG SAYING, "UNFORTUNATELY THIS DOC CALLED BACK AND REACHED A DIFFERENT CSR WHO SAW ADAM APPROVED THE REDRAW, FORGOT TO CHECK WITH ME, AND TOLD THE DOC WE NEED A REDRAW." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE THEN SAYS BELOW, "NEED TO DISCUSS MESSAGING FOR MY CALL WITH THIS DOC, WITH REGARD TO THE REASON FOR REDRAW."
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: AND CAN YOU EXPLAIN THE ROLES THAT YOU AND CHRISTIAN HOLMES HAD IN COMMUNICATING WITH DOCTORS ABOUT THERANOS RESULTS?
ADAM ROSENDORFF: MY UNDERSTANDING OF THE PROCESS WAS THAT CHRISTIAN WOULD RECEIVE QUERIES OR COMPLAINTS FROM CUSTOMER REPRESENTATIVES, HE WOULD THEN FORWARD THOSE TO ME.
MR. BOSTIC: AND BETWEEN THE TWO OF YOU, WAS THERE ONE OF YOU WHO HAD THE ACTUAL JOB OF SPEAKING TO PHYSICIANS ABOUT THE RESULTS, OR WAS THAT HANDLED BY BOTH OF YOU? WHAT WAS YOUR UNDERSTANDING?
ADAM ROSENDORFF: THAT WAS MYSELF.
MR. BOSTIC: AND THE MESSAGE ABOVE THE ONE WE WERE JUST LOOKING AT, CHRISTIAN HOLMES WRITES AGAIN TO SAY, "DANIEL - SORRY TO FLOOD YOUR INBOX WITH THESE TODAY." AT THE BOTTOM OF THAT MESSAGE HE SAYS, "JUST NEED TO KNOW WHAT HAPPENED SO EAH AND I CAN WORK ON MESSAGING TO THE DOC." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: WERE EAH ELIZABETH HOLMES'S INITIALS?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WE CAN PUT THAT ONE ASIDE. THANK YOU. LET'S LOOK AT EXHIBIT 4044. YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4044. IT'S BEEN STIPULATED TO.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4044 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S GO TO PAGE 2, PLEASE. AND IF WE CAN ZOOM IN ON THE TOP HALF.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE THIS EMAIL CHAIN FROM ELIZABETH HOLMES TO YOU AND OTHERS AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HER EMAIL SAYS, "CHECKING IN ON THE DAY BY DAY PLAN FOR AUDIT PREPARATIONS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DO YOU RECALL WHAT AUDIT THIS WOULD BE REFERRING TO IN NOVEMBER OF 2013?
ADAM ROSENDORFF: THIS WOULD BE REFERRING TO THE IMPENDING LABORATORY FIELD SERVICES AUDIT. LABORATORY FIELD SERVICES CONDUCTS AUDITS IN LABORATORIES IN CALIFORNIA ON BEHALF OF CMS.
MR. BOSTIC: AND SO WHO EMPLOYS THE INDIVIDUALS WHO ARE CONDUCTING THAT AUDIT? WHO DO THEY WORK FOR?
ADAM ROSENDORFF: THEY'RE PART OF THE CALIFORNIA DEPARTMENT OF PUBLIC HEALTH. LABORATORY FIELD SERVICES IS A DIVISION OF CDPH.
MR. BOSTIC: AND MS. HOLMES IS ASKING HERE FOR INFORMATION ABOUT THE DAY BY DAY PLAN FOR PREPARATIONS FOR THAT AUDIT; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND LET'S LOOK AT PAGE 1 OF THIS EXHIBIT, PLEASE. DR. ROSENDORFF, ON PAGE 1 DO YOU SEE AN EMAIL FROM YOU IN RESPONSE LISTING SOME BULLET POINTS AS PART OF THE PREPARATION PLAN FOR THAT AUDIT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 4047. THAT SHOULD BE THE NEXT ONE IN YOUR BINDER. YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT THIS AS WELL. I BELIEVE THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4047 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: AND LET'S ZOOM IN ON THE TOP HALF OF THE PAGE, PLEASE.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AT THE BOTTOM OF THE SCREEN AN EMAIL FROM ELIZABETH HOLMES TO YOU AND OTHERS AT THERANOS CC'ING SUNNY BALWANI AT THE BOTTOM OF THE PAGE?
ADAM ROSENDORFF: YES. I'M SORRY. I DIDN'T MEAN TO INTERRUPT YOU.
MR. BOSTIC: AND DO YOU SEE THAT THE TEXT OF THAT MESSAGE SAYS, "LET ME KNOW IF THE PATH FOR WALKING THE AUDITORS IN AND DOWNSTAIRS HAS BEEN CEMENTED SO WE AVOID AREAS THAT CANNOT BE ACCESSED, AND WHAT THAT PATH IS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: DO YOU RECALL DURING YOUR TIME AT THERANOS ANY DISCUSSION ABOUT THE AREAS OF THE COMPANY THAT AUDITORS COULD AND COULD NOT SEE?
ADAM ROSENDORFF: YES, I REMEMBER DISCUSSING WITH ELIZABETH HOLMES AND SUNNY SPECIFICALLY THAT NOBODY WAS ALLOWED TO GO IN OR OUT OF THE NORMANDY LAB DURING THE TIME OF THE INSPECTION.
MR. BOSTIC: AND THE EMAIL CHAIN ABOVE THAT, OR SORRY, THE EMAIL MESSAGE ABOVE THAT IS FROM MS. HOLMES AGAIN AND IT SAYS IN PARENTHESIS, "(KERRY, PLEASE DELINEATE THIS BASED ON WHAT WE DID WITH THE NEW YORK INSPECTOR RECENTLY AND SEND THAT OUT.)" DO YOU RECALL THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND DO YOU RECALL THE NEW YORK INSPECTOR'S VISIT AND ANY AREAS THAT WERE OFF LIMITS OR INCLUDED DURING THAT VISIT?
ADAM ROSENDORFF: I WAS NOT INVOLVED IN THE NEW YORK STATE AUDIT.
MR. BOSTIC: THE DIRECTION THAT YOU JUST REFERENCED, THAT NO ONE SHOULD COME OR GO DURING NORMANDY, WHAT INSPECTION WAS THAT DURING?
ADAM ROSENDORFF: IT WAS DURING -- IT REFERRED TO THE ALCHEMIST OR THE CLIA INSPECTION IN NOVEMBER.
MR. BOSTIC: AND WHO SPECIFICALLY GAVE THAT DIRECTION THAT NO ONE SHOULD COME OR GO FROM THE LAB DURING THAT INSPECTION?
ADAM ROSENDORFF: IT CAME FROM SUNNY.
MR. BOSTIC: DID YOU RECEIVE ANY DIRECTION ABOUT WHETHER TO SHOW AUDITORS OR INSPECTORS THE NORMANDY DURING THAT VISIT?
ADAM ROSENDORFF: SO STANDARD PRACTICE DURING AN INSPECTION IS TO SHOW THE AUDITORS WHAT THEY ASKED FOR. THEY ASKED FOR VALIDATION STUDIES FOR THE EDISON INSTRUMENT AND FOR THE MODIFIED SIEMENS LDT'S. WE SHOWED THEM THESE STUDIES. WHILE THIS WAS GOING ON, I EMAILED DANIEL YOUNG AND ASKED HIM IF WE SHOULD MENTION THE DOWNSTAIRS LAB, AND HE SAID NOT UNLESS THEY SPECIFICALLY BRING IT UP OR REQUEST TO SEE IT.
MR. BOSTIC: AND JUST AS A REMINDER, WHAT WAS IN THE DOWNSTAIRS LAB AT THERANOS?
ADAM ROSENDORFF: THE SIEMENS INSTRUMENTING RUNNING THE LDT'S, THE TECAN LIQUID HANDLERS, SOFTWARE THAT WOULD INTERFACE WITH THIS EQUIPMENT, A ROBOT TO HANDLE SPECIMENS AS THEY CAME IN, CENTRIFUGES, ET CETERA.
MR. BOSTIC: DURING THIS INSPECTION, WERE YOU WITH THE AUDITOR OR AUDITORS DURING THE COURSE OF THE DAY?
ADAM ROSENDORFF: FOR THE MAJORITY OF IT, YES.
MR. BOSTIC: AND WAS THERE A SPECIFIC PORTION WHERE YOU WEREN'T WITH THEM?
ADAM ROSENDORFF: CORRECT. I RETIRED TO MY OFFICE WHILE THE INSPECTOR WAS REVIEWING DOCUMENTATION IN THE UPSTAIRS LABORATORY.
MR. BOSTIC: TO YOUR KNOWLEDGE, AT ANY POINT DURING THAT DAY WERE THE INSPECTORS SHOWN AN EDISON DEVICE?
ADAM ROSENDORFF: NOT TO MY KNOWLEDGE. THERE WAS DISCUSSION BETWEEN DANIEL YOUNG AND THE AUDITOR AT THE BEGINNING OF THE AUDIT AROUND WHAT WAS PROPRIETARY AND WHAT MIGHT NOT BE REVEALED AND WHAT COULD BE SHOWN. I DON'T KNOW THE SPECIFICS OF THAT DISCUSSION, BUT THAT WAS BROUGHT UP.
MR. BOSTIC: I'LL ASK YOU TO LOOK AT EXHIBIT 2149, PLEASE. DO YOU HAVE 2149 IN FRONT OF YOU?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: IS THIS AN EMAIL CHAIN INCLUDING CORRESPONDENCE BETWEEN YOU AND DANIEL YOUNG AND OTHERS AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 2149.
ADAM ROSENDORFF: SO -- I'M SORRY. I DON'T KNOW IF I'M ON THE RIGHT EXHIBIT. I'M ON EXHIBIT 2149. THE FIRST HEADER SHOWS ME CC'ING THIS TO MY GMAIL ACCOUNT. THE SECOND HEADER IS AN EMAIL FROM DANIEL YOUNG TO A NUMBER OF PEOPLE, INCLUDING MYSELF.
BY MR. BOSTIC:
MR. BOSTIC: YOU'RE ON THE RIGHT DOCUMENT. YOU'RE IN THE RIGHT PLACE.
ADAM ROSENDORFF: OKAY.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT THIS EXHIBIT AT THIS TIME.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 2149 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN JUST CAPTURE THE TOP HALF OF THE PAGE APPROXIMATELY. LET'S GO DOWN A LITTLE BIT FURTHER. THAT'S GOOD. THANK YOU.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AT THE BOTTOM OF THE PAGE THERE'S SOME CORRESPONDENCE BETWEEN YOU, DANIEL YOUNG, AND OTHERS FROM SEPTEMBER 2013?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND IN YOUR EMAIL, THE FIRST LINE SAYS, "I FAVOR ESTABLISHING DE-NOVO REFERENCE RANGES ON CAPILLARY BLOOD BASED ON ALREADY COLLECTED AND WALGREENS NORMALS." DO YOU SEE THAT TEXT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND DO YOU RECALL THIS CONVERSATION GENERALLY?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AT THE TOP OF THE PAGE, YOU FORWARD THAT EMAIL CHAIN TO YOUR PERSONAL EMAIL; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE EMAIL IS SEPTEMBER 2013, BUT YOU FORWARDED IT MORE THAN A YEAR LATER; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: WHY DID YOU DECIDE TO FORWARD THIS EMAIL CHAIN TO YOURSELF IN OCTOBER OF 2014?
ADAM ROSENDORFF: DESPITE MY BEST EFFORTS TO IMPROVE ASSAYS, TO WORK MY HARDEST WITH THE COMPANY, TO ALERT MANAGEMENT TO PROBLEMS, THE NUMBER AND SEVERITY OF ISSUES HAD REACHED A CRESCENDO FOR ME. AT THAT TIME IN OCTOBER OF 2014, AS I MENTIONED, I THINK I ALREADY DISCUSSED THE REASONS WHY I FORWARDED THE EMAIL IN GENERAL TO MY GMAIL ACCOUNT.
MR. BOSTIC: AND I THINK THERE WAS SOMETHING AT THIS POINT IN TIME THAT CAUSED YOU TO CONTINUE WITH THAT PRACTICE.
ADAM ROSENDORFF: IT WAS AROUND THIS TIME THAT WE WERE GETTING A HIGH FREQUENCY OF DOCTOR COMPLAINTS.
MR. BOSTIC: AND REMIND US WHEN APPROXIMATELY DID YOU LEAVE THE COMPANY?
ADAM ROSENDORFF: NOVEMBER 2014.
MR. BOSTIC: AND SO WE'RE NOW IN YOUR FINAL WEEKS WITH THERANOS; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND LET'S LOOK AT EXHIBIT 4323 NEXT. YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT THIS. I BELIEVE THE DEFENSE HAS STIPULATED.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4323 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: LET'S START ON PAGE 4 OF THIS EXHIBIT -- DR. ROSENDORFF, DO YOU SEE -- LET'S ZOOM IN ON THAT FIRST EMAIL MESSAGE AT THE BOTTOM. DR. ROSENDORFF, DO YOU SEE THIS BEGINS WITH AN EMAIL TO CHRISTIAN HOLMES ABOUT A DOCTOR CALLING ABOUT HDL AND LDL RESULTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHAT ARE HDL AND LDL?
ADAM ROSENDORFF: HIGH DENSITY LIPO PROTEIN AND LOW DENSITY LIPO PROTEIN.
MR. BOSTIC: AND GENERALLY SPEAKING, WHAT IS THE CLINICAL SIGNIFICANCE OF THOSE?
ADAM ROSENDORFF: PATIENTS WITH HIGH LDL OR HIGH TOTAL CHOLESTEROL ARE AT RISK FOR HEART DISEASE. BY CONTRAST, HIGH HDL IS PROTECTIVE AGAINST HEART DISEASE.
MR. BOSTIC: AND THIS CALL INDICATES THAT A DOCTOR WAS CONCERNED ABOUT HDL AND LDL RESULTS AND THE LIPID PANEL FOR A CERTAIN PATIENT. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND THE RECORD IS THAT HDL AND LDL ARE NOT ADDING UP AND THE DOCTOR THOUGHT THAT THE LDL WAS A FALSE READING. DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I SEE THAT.
MR. BOSTIC: WHY WOULD IT BE A PROBLEM THAT HDL AND LDL WERE NOT ADDING UP?
ADAM ROSENDORFF: THE TOTAL CHOLESTEROL CAN BE ESTIMATED BY ADDING HDL TO LDL AND THEN BY ADDING TRIGLYCERIDES AND DIVIDING THAT VALUE BY 5. IT'S KNOWN AS THE FRIEDEWALD OCCASION. THIS EMAIL SUGGESTS THAT THE M.A. HAD APPLIED THAT FORMULA, AND THEN COMPARED THE TOTAL CALCULATED CHOLESTEROL TO THE ACTUAL CHOLESTEROL MEASURED BY THE LABORATORY.
MR. BOSTIC: AND DID THE RESULTS CALL INTO QUESTION THE ACCURACY OF THE THERANOS TEST?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S GO TO PAGE 3 OF THIS EXHIBIT, PLEASE. LET'S LOOK AT THE BOTTOM HALF OF THE PAGE ON PAGE 3. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM YOU NOW TO CHRISTIAN HOLMES ABOUT THIS TOPIC?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND YOU INDICATE THAT YOU CALLED AND LEFT A MESSAGE WITH THE PROVIDER SAYING THAT THERANOS WOULD ATTEMPT TO RERUN THE SAMPLE; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND YOU THEN DESCRIBE THE PROBLEM BELOW THAT YOU JUST TALKED ABOUT; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S ZOOM OUT AND LOOK AT THE TOP MESSAGE ON THIS PAGE. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM YOU AT THE VERY TOP OF THE PAGE?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: YOU SAY, "SEEMS LIKE A TECHNICAL PROBLEM. THERE ARE NO PATIENT FACTORS THAT WOULD EXPLAIN THIS."
ADAM ROSENDORFF: RIGHT.
MR. BOSTIC: AND WHAT DID YOU MEAN BY THAT?
ADAM ROSENDORFF: I MEANT THAT IT WOULDN'T MATTER, FOR INSTANCE, IF THE PATIENT WAS TAKING CHOLESTEROL LOWERING MEDICATION OR IF THE PATIENT HAD HYPERCHOLESTEROLEMIA. THERE ARE NO PREEXISTING ILLNESSES OR MEDICATIONS THAT WOULD EXPLAIN THIS KIND OF DISCREPANCY.
MR. BOSTIC: AND IF THERE ARE NO PATIENT FACTORS THAT WOULD EXPLAIN IT, WHAT DOES THAT LEAVE AS THE POSSIBLE EXPLANATION?
ADAM ROSENDORFF: TECHNICAL PROBLEM.
MR. BOSTIC: IN OTHER WORDS, A PROBLEM WITH THE TEST ITSELF?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S GO TO PAGE 2 NOW, MOVING FORWARD IN TIME. LET'S ZOOM IN ON THE VERY BOTTOM HALF OF THE PAGE. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM CHRISTIAN HOLMES TO YOU ON NOVEMBER 14TH, 2014?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: HE SAYS, "I ESCALATED THIS AND RECEIVED THE FOLLOWING RESPONSE. ADAM IS THIS SUFFICIENT FOR YOU TO RELAY TO THE DOC?" IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND HE THEN PROVIDES A PURPORTED EXPLANATION FOR THE THERANOS RESULTS; IS THAT CORRECT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S ZOOM OUT AND LOOK AT YOUR RESPONSE JUST ABOVE THAT MESSAGE. MS. HOLLIMAN, IF WE CAN GO DOWN A LITTLE BIT FURTHER. PERFECT. THANK YOU. DR. ROSENDORFF, DO YOU SEE YOUR RESPONSE TO CHRISTIAN HOLMES'S EMAIL AT THE BOTTOM THERE?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND YOU SAY, "I AM GOING TO PASS ON THIS ONE." IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND CHRISTIAN HOLMES THEN ASKS, "CAN YOU PLEASE CLARIFY WHAT YOU MEAN BY THIS?" AND YOU SAY, "IF YOU'RE ASKING ME TO DEFEND THESE VALUES THEN THE ANSWER IS NO." IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND WHY DID YOU REFUSE TO DEFEND THE VALUES IN THIS CASE?
ADAM ROSENDORFF: BECAUSE I DIDN'T BELIEVE THEM TO BE ACCURATE.
MR. BOSTIC: LET'S LOOK AT PAGE 1 AND SEE THE CONTINUATION OF THIS CONVERSATION. LET'S ZOOM IN ON THE BOTTOM MESSAGE. DR. ROSENDORFF, DO YOU SEE THAT CHRISTIAN HOLMES RESPONDS, "THIS CAN BE HANDLED CONSTRUCTIVELY INTERNALLY." AND THEN HE SAYS, "ADAM, IF YOU'RE GOING TO REFUSE TO SPEAK WITH THE CLINICIAN WHO IS ASKING TO SPEAK WITH OUR LAB DIRECTOR ABOUT INTERPRETING A PATIENT'S RESULTS, THEN SO BE IT, BUT SIMPLY PASSING ON GETTING BACK TO THIS DOC IS NOT AN OPTION." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: WERE YOU REFUSING TO SPEAK TO THE DOCTOR AT ALL?
ADAM ROSENDORFF: NO. I WAS REFUSING TO DEFEND THE ACCURACY OF THE RESULT.
MR. BOSTIC: LET'S ZOOM IN ON THE TOP HALF OF THIS PAGE. AND IN THE MIDDLE OF THE SCREEN, DR. ROSENDORFF, DO YOU SEE A MESSAGE FROM ELIZABETH HOLMES TO HER BROTHER CHRISTIAN HOLMES ON NOVEMBER 14TH AT 2:22?
ADAM ROSENDORFF: YES.
MR. BOSTIC: SHE SAYS, "CHRISTIAN: YOU HANDLED THIS EXCELLENTLY. THE LAST NOTE TO ADAM BELOW, ESPECIALLY THE SECOND SENTENCE, WAS EXACTLY RIGHT." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT EXHIBIT 4314. YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT THIS EXHIBIT, 4314. IT'S SUBJECT TO STIPULATION.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4314 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: LET'S LOOK AT THE TOP HALF OF PAGE 2. DR. ROSENDORFF, DO YOU SEE THIS IS A CONTINUATION OF THAT SAME EMAIL CHAIN THAT WE WERE JUST LOOKING AT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: YOUR RESPONSE TO CHRISTIAN IS AT THE TOP OF THE PAGE. YOU SAY, "I WILL HAPPILY SPEAK TO THE CLINICIAN BUT I WILL NOT DEFEND THE RESULTS." WAS THAT YOUR POSITION AT THE TIME?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND LET'S GO TO PAGE 1 NOW AND ZOOM IN ON THE BOTTOM HALF OF THE PAGE. YOU THEN FOLLOW UP WITH YOUR EMAIL TO CHRISTIAN; IS THAT CORRECT?
ADAM ROSENDORFF: YES, I DID.
MR. BOSTIC: AND YOU SAY, "TO CLARIFY, NUMBER 1, THIS IS NOT A QUESTION OF INTERPRETING RESULTS, THIS IS THE QUESTION OF RELIABILITY AND ACCURACY OF THE RESULT." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOU SAY, "THE MOST CONSTRUCTIVE THING AT THIS POINT IS TO OFFER RELIABLE AND ROBUST ASSAYS, NOT TO SPIN." DID YOU FEEL AT THIS TIME YOU WERE BEING ASKED TO SPIN INSTEAD OF PROVIDE RELIABLE AND ROBUST ASSAYS?
ADAM ROSENDORFF: YES, I DID.
MR. BOSTIC: POINT NUMBER 3 IN YOUR EMAIL SAYS, "FURTHER 100 PERCENT HONESTY AND TRANSPARENCY TO THE PATIENT IS ESSENTIAL." AT THIS TIME DID YOU FEEL THAT THERANOS WAS BEING 100 PERCENT HONEST AND TRANSPARENT TO THE PATIENT?
ADAM ROSENDORFF: NO. DESPITE MY DIRECTION, THE COMPANY WAS NOT SHOWING ON THE PATIENT REPORT WHAT THE SAMPLE TYPE WAS, WHETHER IT WAS VENOUS OR CAPILLARY, AND WHAT METHOD WAS BEING USED TO RUN THE SAMPLE. MY INTERACTIONS WITH MANAGEMENT, THEY MADE IT VERY CLEAR WHAT THE MESSAGING SHOULD BE.
MR. BOSTIC: AND WHAT WAS THE MESSAGE -- WHAT WAS THE MESSAGING DIRECTION THAT YOU RECEIVED FROM MANAGEMENT?
ADAM ROSENDORFF: THE MESSAGING WOULD BE TO DEFEND THE RESULTS BY COMING UP WITH PATIENT FACTORS THAT WOULD EXPLAIN DISCREPANCIES.
MR. BOSTIC: LET'S ZOOM OUT AND LOOK AT THE VERY TOP MESSAGE ON THIS PAGE, PAGE 1. DO YOU SEE THERE, DR. ROSENDORFF, AN EMAIL FROM CHRISTIAN HOLMES TO ELIZABETH HOLMES AND SUNNY BALWANI STATING, "HIS RESPONSE TO THIS WAS TO DO A VACUTAINER REDRAW AND I ENDED THE CONVERSATION AT THAT POINT."
ADAM ROSENDORFF: I JUST WANTED TO ADD SOMETHING RELATED TO MY PREVIOUS COMMENTS.
MR. BOSTIC: GO AHEAD.
ADAM ROSENDORFF: THE FACT THAT THE SAMPLE TYPE AND METHOD TYPE WAS NOT SHOWN ON THE REPORT MADE IT VERY DIFFICULT FOR ME TO TROUBLESHOOT OR INTERPRET RESULTS AS A LABORATORY DIRECTOR. IN OTHER WORDS, THIS INFORMATION WAS NOT AVAILABLE TO THE PHYSICIANS AND IT WAS NOT TRANSPARENT TO ME EITHER.
MR. BOSTIC: THANK YOU.
ADAM ROSENDORFF: I COULD FIND OUT -- I WAS ABLE TO FIND OUT THAT INFORMATION, BUT IT REQUIRED A LOT OF EFFORT.
MR. BOSTIC: SO YOU HAD ACCESS TO THAT INFORMATION THROUGH EFFORT; IS THAT RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND DID PHYSICIANS HAVE ACCESS TO THAT SAME INFORMATION IF THEY NEEDED IT?
ADAM ROSENDORFF: IT WAS NOT ON THE REPORT. I DON'T RECALL ANY PHONE CALLS ASKING US WHETHER SAMPLES WERE RUN ON VENOUS BLOOD OR CAPILLARY BLOOD.
MR. BOSTIC: WERE YOU PERMITTED TO TELL PHYSICIANS ABOUT THE SPECIFIC METHODS USED TO RUN THERANOS TESTS?
ADAM ROSENDORFF: I DIDN'T RECEIVE EXPLICIT INSTRUCTION NOT TO, SO IF I WAS ASKED, I WOULD, I WOULD TELL PHYSICIANS. I ALSO THINK IT'S GOOD MEDICAL CARE AND PATIENT CARE TO TELL PHYSICIANS ABOUT THIS, ABOUT THESE ISSUES.
MR. BOSTIC: BUT YOUR RECOMMENDATION WAS TO INCLUDE THAT INFORMATION ON THE REPORT ITSELF?
ADAM ROSENDORFF: CORRECT, CORRECT.
MR. BOSTIC: AND GOING BACK TO EXHIBIT 4314. CHRISTIAN HOLMES'S EMAIL REPORTS THAT YOUR POSITION WAS TO DO A VACUTAINER REDRAW. WHAT WOULD THAT MEAN IN THIS CASE?
ADAM ROSENDORFF: IT WOULD MEAN TO DRAW VENOUS BLOOD AND TO RUN THAT SAMPLE ON AN FDA APPROVED COMMERCIALLY AVAILABLE INSTRUMENT.
MR. BOSTIC: IN OTHER WORDS, A NON-THERANOS METHOD?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: I'LL ASK YOU TO LOOK NOW AT EXHIBIT 4330, PLEASE. YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT 4330. THE DEFENSE HAS STIPULATED.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4330 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: LET'S START WITH PAGE 3 OF THIS EXHIBIT. AND IF WE CAN ZOOM IN ON THAT EMAIL. DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM YOU ON NOVEMBER 14TH, 2014 TO MS. HOLMES AND MR. BALWANI?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND YOU SAY IN THIS EMAIL, "I AM HEARING THAT THERANOS INTENDS TO TEST SAMPLES TO RULE OUT OR DIAGNOSE EBOLA AT 7373 GATEWAY. "CAN YOU PLEASE CONFIRM THAT THIS IS CORRECT. IF SO, I AM WONDERING WHY, AS LAB DIRECTOR, I WAS NOT INVOLVED IN THE DECISION." DO YOU SEE THAT?
ADAM ROSENDORFF: I SEE THAT.
MR. BOSTIC: LET'S LOOK AT PAGE 2 AND CAPTURE THE BOTTOM OF THE PAGE. MS. HOLMES RESPONDS TO YOU TO SAY "THAT IS NOT CORRECT. WHO SAID THIS?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: YOU SUGGEST A COMPANY-WIDE EMAIL?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S LOOK AT THE TOP OF THIS PAGE. YOU THEN FOLLOW UP ON THIS EMAIL CHAIN TO SAY, "ELIZABETH, I FEEL REALLY UNCOMFORTABLE WITH WHAT IS HAPPENING RIGHT NOW IN THIS COMPANY. IS THERE ANY WAY YOU CAN GET SPENCER BACK ON THE CLIA LICENSE AND TAKE ME OFF? I AM FEELING PRESSURED TO VOUCH FOR RESULTS THAT I CANNOT BE CONFIDENT IN AND ALSO IN A NUMBER OF CASES WHERE I GET QUESTIONS ABOUT ASSAYS, I DO NOT KNOW WHAT METHOD IS BEING USED. IE VACUTAINERS, ILIQUOTTED INTO CTN'S, ET CETERA." WHAT PROMPTED YOU TO SEND THIS MESSAGE AT THIS TIME?
ADAM ROSENDORFF: IT WAS THE CULMINATION OF A LARGE NUMBER OF THE ISSUES THAT WE HAVE BEEN DISCUSSING DURING MY TESTIMONY, AND I WAS PARTICULARLY DISTURBED BY THE FACT THAT WHAT WAS BEING DONE AT THE COMPANY WAS NOT VISIBLE TO ME IN TERMS OF THE EBOLA EMAIL THAT I MENTIONED AND IN TERMS OF THE METHODS BEING RUN, ET CETERA.
MR. BOSTIC: AND LET'S LOOK AT PAGE 1 TO SEE MS. HOLMES'S RESPONSE. IT'S AN EMAIL ON THE BOTTOM OF THE PAGE. MS. HOLMES RESPONDS, "HOW SAD AND DISAPPOINTING TO SEE THIS FROM YOU." SHE SAID, "OUTSIDE OF THE FACT THAT YOU'VE NEVER EMAILED ME ON ANY CONCERNS YOU ALLUDE TO THERE BEFORE BUT NOW EMAIL THIS, YOU KNOW FROM EVERY CONVERSATION WE'VE EVER HAD TOGETHER HOW FUNDAMENTAL IT IS TO ALL OF US FOR YOU OR ANY OTHER EMPLOYEE NEVER TO DO ANYTHING YOU'RE NOT COMPLETELY CONFIDENT IN." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND DID YOU AGREE WITH THOSE WORDS AT THE TIME?
ADAM ROSENDORFF: NO, I DID NOT.
MR. BOSTIC: WHY NOT?
ADAM ROSENDORFF: I HAD FREQUENT CONVERSATIONS WITH ELIZABETH ABOUT CONCERNS THAT I HAD IN THE LABORATORY. I -- AS THE JURY HAS SEEN, A NUMBER OF EMAILS DEALING WITH THESE ISSUES WERE CC'D TO ELIZABETH, AND THAT WAS VISIBLE TO ME AS WELL. I EMAILED ELIZABETH DIRECTLY ON OCCASION TO ALERT HER TO CONCERNS. I HAD AT LEAST ONE MEETING IN HER OFFICE BEFORE THE LAUNCH TO DISCUSS MY CONCERNS.
MR. BOSTIC: YOUR REQUEST TO BE TAKEN OFF OF THE CLIA LICENSE AND PUT SOMEONE ELSE ON, IN EFFECT, WHAT WOULD THAT MEAN WITH RESPECT TO YOUR LAB DIRECTOR POSITION?
ADAM ROSENDORFF: I WOULD NO LONGER BE THE CLIA LABORATORY DIRECTOR OF RECORD, AND IN THE EYES OF THE STATE AND THE FEDERAL GOVERNMENT, I WOULD NOT BE THE PERSON RESPONSIBLE FOR THE LABORATORY.
MR. BOSTIC: WE CAN PUT THAT ASIDE. YOUR HONOR, THE GOVERNMENT WOULD LIKE TO ADMIT TWO PAGES OF 5387A, AND THESE WERE AUTHENTICATED THROUGH A PREVIOUS WITNESS, AND AT THIS TIME THE GOVERNMENT IS ADMITTING PAGE 28 AND PAGE 33 FOR ADMISSION INTO EVIDENCE. I DON'T BELIEVE IT'S IN THE BINDER, BUT I DO HAVE ONE COPY IF THE COURT WOULD LIKE TO REVIEW.
JUDGE DAVILA: PLEASE. IS THERE ANY OBJECTION?
MR. BOSTIC: I DON'T HAVE A COPY FOR THE DEFENSE, BUT I DID GIVE THEM NOTICE ABOUT THESE.
JUDGE DAVILA: WHY DON'T WE SHOW MR. WADE FIRST. THANK YOU.
MR. BOSTIC: EXHIBIT NUMBER 5387A, PAGES 28 AND 33.
JUDGE DAVILA: THOSE TWO PAGES, PAGE 28 AND 33, ARE ADMITTED. THEY MAY BE PUBLISHED.
MR. BOSTIC: THANK YOU, YOUR HONOR.
(GOVERNMENT'S EXHIBIT 5387A, PAGES 28 AND 33, WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN FIRST CAPTURE THE CONTENT OF THIS TEXT EXCHANGE.
MR. BOSTIC: DR. ROSENDORFF, DURING YOUR TIME AT THE COMPANY, YOU DIDN'T HAVE ACCESS TO TEXT MESSAGES BETWEEN ELIZABETH HOLMES AND SUNNY BALWANI; CORRECT?
ADAM ROSENDORFF: NO, I DID NOT.
MR. BOSTIC: EXHIBIT 5387A, PAGE 28, CONTAINS AN EXCHANGE. FIRST THERE'S A MESSAGE FROM ELIZABETH HOLMES THAT READS: "JUST FINISHED CALLS. ALICE WALTON IN FOR 50. "CONFIRMED 100 GREG." DO YOU SEE THAT LANGUAGE?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND THERE'S A RESPONSE FROM MR. BALWANI, "AWESOME. "I WAS THINKING TODAY. THEY ARE NOT INVESTING IN OUR COMPANY. "THEY ARE INVESTING IN OUR DESTINY." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND MR. BALWANI SAYS, "SO TOTAL 10." MS. HOLMES RESPONDS, "150 TOTAL." AND MS. HOLMES SAYS, "RUPERT OVER 100." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND MR. BALWANI SAYS, "AWESOME. "CAN'T WAIT TO LEARN MORE ABOUT CONVERSATION WITH RUPERT." DURING THE EVENTS WE HAVE BEEN DISCUSSING WHEN YOU WERE HAVING CONCERNS WITH THERANOS TESTING ACCURACY, WERE YOU AWARE THAT MR. BALWANI AND MS. HOLMES WERE RAISING TENS OF MILLIONS OF DOLLARS FROM INVESTORS?
ADAM ROSENDORFF: I WAS AWARE THAT INVESTING WAS OCCURRING, YES.
MR. BOSTIC: AND WERE YOU INVOLVED IN SPEAKING TO INVESTORS AT ALL OR SECURING THOSE INVESTMENTS FOR THE COMPANY?
ADAM ROSENDORFF: NO, NOT AT ALL.
MR. BOSTIC: LET'S LOOK BRIEFLY AT EXHIBIT 2228 IN YOUR BINDER. DR. ROSENDORFF -- ACTUALLY, YOUR HONOR, I BELIEVE THIS IS SUBJECT TO STIPULATION AND THE GOVERNMENT MOVES TO ADMIT 2228.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 2228 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S START, MS. HOLLIMAN, WITH PAGE 2, PLEASE. LET'S ZOOM IN ON THE BOTTOM HALF OF THE PAGE.
MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE AN EMAIL TO YOU AND CLS GROUP ON NOVEMBER 21ST, 2014?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: IS THIS JUST DAYS BEFORE YOU LEFT THE COMPANY?
ADAM ROSENDORFF: YES, IT IS.
MR. BOSTIC: THE MESSAGE SAYS, "HI ADAM, PLEASE APPROVE A REDRAW FOR CMP FOR," AND THEN THE PATIENT NAME IS REDACTED, "THE CHLORIDE WAS CRITICAL HIGH AND THE COLLECTED CTN WAS QNS FOR RERUN." WHAT DOES QNS MEAN IN THIS CONTEXT?
ADAM ROSENDORFF: QUANTITY NOT SUFFICIENT.
MR. BOSTIC: IN OTHER WORDS, THERE WASN'T ENOUGH OF THE SAMPLE TO RERUN?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: LET'S ZOOM IN ON THE TOP HALF OF THIS PAGE, PLEASE. YOU FORWARD THIS INFORMATION TO ELIZABETH HOLMES AND SUNNY BALWANI; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND YOU SAY, "ELIZABETH/SUNNY, WE ARE STILL VOIDING CRITICAL ISE RESULTS AND ASKING FOR REDRAW. THIS MEANS WE WOULD MISS A TRULY CRITICAL ISE RESULT. BY THE SAME TOKEN, IT CALLS INTO QUESTION THE ACCURACY OF EVEN THE NORMAL ISE RESULTS. "ARE YOU BOTH COMFORTABLE WITH THIS?" CAN YOU EXPLAIN WHAT YOUR CONCERN WAS IN THIS CASE?
ADAM ROSENDORFF: FIRST OF ALL, PHYSICIANS WOULD HAVE BEEN ORDERING THESE TESTS AND EXPECTING TO GET RESULTS BACK FROM THE LAB. WE WERE VOIDING THE CRITICAL RESULTS BY RULE, BY DEFAULT. SO THE VERY CLINICAL SITUATIONS THAT WOULD REQUIRE ACCURATE REPORTING OF CRITICAL ISE RESULTS WOULD THEN NOT BE REPORTED. SO THAT MEANS WE WOULD MISS A TRULY CRITICAL ISE RESULT AND WE WOULDN'T BE REPORTING IT, AND IT ALSO CALLED INTO QUESTION THE ACCURACY OF THE ISE RESULTS THAT WERE WITHIN THE NORMAL RANGE.
MR. BOSTIC: AND YOU ASK MS. HOLMES AND MR. BALWANI IF THEY WERE COMFORTABLE WITH THIS. WERE YOU COMFORTABLE WITH THIS AT THE TIME?
ADAM ROSENDORFF: NO, I WAS NOT.
MR. BOSTIC: LET'S LOOK AT PAGE 1 OF THIS EXHIBIT, AND LET'S ZOOM IN ON THE BOTTOM OF THAT PAGE. DR. ROSENDORFF, DO YOU SEE A RESPONSE FROM SUNNY BALWANI ON YOUR SCREEN?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND HE SAYS, "ADAM. SEE ATTACHED. "MICHAEL JUMPED THE GUN IN REQUESTING THIS REDRAW. AND SO DID YOU IN JUMPING TO CONCLUSION WITHOUT UNDERSTANDING THE PROCESS." AND THEN HE SAYS, "WE HAVE VERY HIGH CONFIDENCE IN EVERY RESULT WE ARE RELEASING." DID YOU AGREE WITH THAT RESPONSE?
MR. BOSTIC: AND LET'S ZOOM OUT AND LOOK AT YOUR RESPONSE. YOU THEN FORWARD MR. BALWANI'S RESPONSE TO MS. HOLMES; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: YOU SAY, "ELIZABETH, I FIND SUNNYS RESPONSE OFFENSIVE AND DISINGENUOUS. HE SHOULD APOLOGIZE." IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND LET'S LOOK, PLEASE, NOW, AT THE TOP MESSAGE IN THIS EMAIL CHAIN. MR. BALWANI WRITES TO MS. HOLMES AFTER SHE FORWARDS HIM YOUR MESSAGE; IS THAT CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: AND HE SAYS, "WE NEED TO RESPOND TO HIM NOW AND CUT HIM MONDAY." DO YOU SEE THAT MESSAGE?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: HOW DID IT COME THAT YOU SEPARATED FROM THE COMPANY? WHAT WERE THE CIRCUMSTANCES OF YOUR DEPARTURE?
ADAM ROSENDORFF: I ACCEPTED AN OFFER OF EMPLOYMENT FROM ANOTHER DIAGNOSTIC LABORATORY I BELIEVE IN OCTOBER OR THEREABOUTS. I EMAILED SUNNY AND ELIZABETH TO THANK THEM FOR THE OPPORTUNITY FOR WORKING AT THERANOS AND TO GIVE THEM ENOUGH TIME THAT THEY COULD FIND ANOTHER LABORATORY DIRECTOR. THIS EMAIL FROM SUNNY SAYING THAT THEY NEED TO CUT ME ESSENTIALLY MEANS THAT THEY WOULD HAVE FIRED ME A FEW DAYS BEFORE I HAD INTENDED TO QUIT ANYWAY.
MR. BOSTIC: AT ANY POINT DURING YOUR FINAL WEEKS AT THE COMPANY, DID MS. HOLMES OR MR. BALWANI ASK YOU TO STAY AT THE COMPANY TO HELP FIX THE PROBLEMS THAT YOU WERE SEEING WITH THE THERANOS TESTS?
ADAM ROSENDORFF: ON MY LAST DAY AT THE COMPANY I WAS SCHEDULED TO MEET WITH SUNNY. HE EXTENDED HIS HAND TO ME. I DECLINED TO SHAKE HIS HAND. HE THEN ASKED ME TO SIGN SOME DOCUMENTS REMOVING ME AS LABORATORY DIRECTOR AT THE THERANOS LAB AND THE ARIZONA LABORATORY. HE THEN MENTIONED THAT HE WOULD BE PREPARED TO KEEP ME ON AS LABORATORY DIRECTOR IF I WANTED TO. I SAID NO, IT WASN'T WORTH THE RISK TO MY REPUTATION TO DO THAT.
MR. BOSTIC: AND WAS YOUR THINKING THERE BASED ON THE PROBLEMS THAT YOU WERE SEEING WITH THE THERANOS TESTS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: LET'S GO BACK, PLEASE, TO EXHIBIT 5387A, AND LET'S LOOK AT PAGE 33 NOW. DR. ROSENDORFF, ARE YOU LOOKING AT A TEXT EXCHANGE BETWEEN MS. HOLMES AND MR. BALWANI IN DECEMBER OF 2014?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WOULD THIS BE AFTER YOU LEFT THE COMPANY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND MS. HOLMES WRITES AT THE TOP: "THIS YEAR IS OUR YEAR." SHE SAYS. "WE CAN NEVER FORGET THIS TIGER." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: AND MR. BALWANI SAYS, "I KNOW. I AM FOCUSSED ON IT. "WE WILL EXECUTE THIS YEAR." MS. HOLMES SAYS, "I KNOW. "I AM FOCUSSED ON IT TOO. "AND FOR OUR KIDS NEVER FORGET WHO WE ARE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, I DO.
MR. BOSTIC: MR. BALWANI IS SAYING "WE WILL EXECUTE THIS YEAR" IN DECEMBER OF 2014. CAN YOU REMIND US WHEN THERANOS FIRST BEGAN OFFERING PATIENT TESTING TO THE PUBLIC?
ADAM ROSENDORFF: SEPTEMBER 9TH, 2013.
MR. BOSTIC: MAY I HAVE A MOMENT, YOUR HONOR?
JUDGE DAVILA: YES.
(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ROSENDORFF, AFTER YOU LEFT THERANOS, DID YOU DISCUSS THINGS THAT YOU HAD SEEN AT THE COMPANY WITH ANYONE ELSE?
ADAM ROSENDORFF: YES, I DID.
MR. BOSTIC: YOU MENTIONED EARLIER THAT ONE REASON THAT YOU FORWARDED EMAILS TO YOURSELF WAS BECAUSE YOU THOUGHT YOU NEEDED TO GET THE WORD OUT ABOUT THERANOS.
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WHO DID YOU SPEAK TO, IF ANYONE, TO MAKE THAT HAPPEN?
ADAM ROSENDORFF: I SPOKE TO NANCY HERSH, A LAWYER. I THEN RECEIVED A PHONE CALL FROM JOHN CARREYROU WITH "THE WALL STREET JOURNAL" AND I SPOKE OFF THE RECORD REGARDING MY EXPERIENCE AT THERANOS.
MR. BOSTIC: AND WHY DID YOU DECIDE TO SPEAK TO THE JOURNALIST ABOUT YOUR EXPERIENCE AT THE COMPANY?
ADAM ROSENDORFF: EVEN MONTHS AFTER I LEFT THE COMPANY, I FELT OBLIGATED FROM A MORAL AND ETHICAL PERSPECTIVE TO ALERT THE PUBLIC. I DIDN'T QUITE KNOW HOW I SHOULD DO THAT, BUT WHEN THIS OPPORTUNITY PRESENTED ITSELF, I TOOK ADVANTAGE OF IT.
MR. BOSTIC: I'D LIKE TO ASK YOU JUST A COUPLE OF DIFFERENT QUESTIONS ABOUT PROFICIENCY TESTING IF I COULD. PRIOR TO SEPTEMBER 2013, DO YOU HAVE AN UNDERSTANDING OF HOW THERANOS WAS CONDUCTING ITS PROFICIENCY TESTING?
ADAM ROSENDORFF: PRIOR TO DECEMBER 2013?
MR. BOSTIC: PRIOR TO SEPTEMBER OF 2013. SO BEFORE THE COMMERCIAL LAUNCH, ARE YOU AWARE OF ANY PROFICIENCY TESTING HAPPENING AT THERANOS?
MR. BOSTIC: YOU TESTIFIED BEFORE --
ADAM ROSENDORFF: I ALSO WANT TO ADD THAT I ALSO SPOKE TO SAM SHELDON, A LAWYER -- AT THE TIME HE WAS AT QUINN EMANUEL. I WAS REFERRED TO HIM BY "THE WALL STREET JOURNAL" JOURNALIST.
MR. BOSTIC: UNDERSTOOD. YOU TESTIFIED EARLIER ABOUT THE KIND OF TESTING THAT WAS BEING CONDUCTED AT THERANOS PRIOR TO THE COMMERCIAL LAUNCH. DO YOU RECALL THAT TESTIMONY?
ADAM ROSENDORFF: YES.
MR. BOSTIC: AND WAS THE TESTING THAT WAS DONE PRIOR TO SEPTEMBER 2013 ON THERANOS SPECIFIC DEVICES OR WAS IT ON FDA APPROVED COMMERCIAL ANALYZERS?
ADAM ROSENDORFF: FDA APPROVED COMMERCIAL ANALYZERS.
MR. BOSTIC: AND BY THE TIME YOU LEFT THERANOS IN NOVEMBER OF 2014, HAD THERANOS IMPLEMENTED PROFICIENCY TESTING IN THE WAY THAT YOU HAD RECOMMENDED?
MR. BOSTIC: IN NOVEMBER OF 2013, WAS YOUR DECISION TO LEAVE THE COMPANY SOMETHING THAT YOU TOOK LIGHTLY?
ADAM ROSENDORFF: NOVEMBER 2014.
MR. BOSTIC: NOVEMBER 2014.
ADAM ROSENDORFF: NO. IT WAS AFTER CONSIDERABLE EFFORT ON MY PART TO IMPROVE THE TESTING METHODOLOGY AT THERANOS, ENDLESS MEETINGS AND CONVERSATIONS, VERY CAREFUL STUDY OF THE MEDICAL LITERATURE, LATE NIGHTS, GREAT EFFORT ON MY PART TO IMPROVE THE QUALITY AT THERANOS.
MR. BOSTIC: THANK YOU, DR. ROSENDORFF. NO FURTHER QUESTIONS AT THIS TIME, YOUR HONOR.
JUDGE DAVILA: MR. WADE, DO YOU HAVE CROSS-EXAMINATION?
JUDGE DAVILA: LET'S TAKE OUR MORNING BREAK NOW, LADIES AND GENTLEMEN. WE'LL TAKE OUR BREAK. WE'LL TAKE A 30 MINUTE BREAK AT THIS TIME, 30 MINUTES, PLEASE. AND I MEANT TO MENTION AT THE BEGINNING, IS THERE ANY OBJECTION TO GOING TO 3:00 P.M. TODAY? 3:00 P.M. TODAY? IS THERE ANY PROBLEM THAT WOULD PRESENT WITH ANYONE? IF SO, PLEASE RAISE YOUR HAND. I SEE NONE. THANK YOU. I'D LIKE TO GO TO AT LEAST 3:00 TOMORROW --
ADAM ROSENDORFF: YOUR HONOR, MAY I SAY SOMETHING?
JUDGE DAVILA: OH, YES.
ADAM ROSENDORFF: I HAVE CHILDCARE OBLIGATIONS TOMORROW AFTERNOON. I WOULD PREFER TO FINISH AT 2:00 TOMORROW. I DON'T KNOW IF THAT'S POSSIBLE.
JUDGE DAVILA: ALL RIGHT. WELL, THANK YOU FOR THAT. THANK YOU FOR THAT. I APPRECIATE THAT. IT SOUNDS LIKE WE'LL SEE IF THAT CAN BE ACCOMPLISHED. THANK YOU.
ADAM ROSENDORFF: THANK YOU.
JUDGE DAVILA: SO TOMORROW I'D LIKE TO GO UNTIL PERHAPS 3:00, AND I MIGHT ASK YOU TO LOOK AT YOUR SCHEDULES IF WE CAN GO UNTIL 4:00 TOMORROW IF THAT'S NOT IN -- DON'T ANSWER ME NOW, BUT CHECK YOUR SCHEDULE, PLEASE. FRIDAY WE'LL FINISH AT 2:00, AND IT MAY BE THAT WE'LL FINISH AT 1:00, BUT NO LATER THAN 2:00 FOR CERTAIN. THAT'S OUR TENTATIVE SCHEDULE. THANK YOU VERY MUCH.
COURT CLERK: COURT IS IN RECESS.
(RECESS FROM 10:42 A.M. UNTIL 11:18 A.M.)
JUDGE DAVILA: WE'RE BACK ON THE RECORD. THE JURY IS PRESENT. THE ALTERNATES ARE PRESENT. ALL COUNSEL ARE PRESENT AND THE DEFENDANT IS PRESENT. THE WITNESS IS ON THE STAND. MR. WADE, DO YOU HAVE CROSS-EXAMINATION?
JUDGE DAVILA: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND THESE ARE STATEMENTS OF YOURS AND THERE ARE TIMES THAT I WILL ASK YOU ABOUT YOUR STATEMENTS AND KNOW THAT THAT'S WHAT THESE YELLOW BINDERS ARE.
ADAM ROSENDORFF: THANK YOU. THESE ARE DURING MY TESTIMONY?
ADAM ROSENDORFF: THANKS.
CROSS-EXAMINATION BY MR. WADE:
ADAM ROSENDORFF: NO, SIR.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: NOT IN PERSON, NO.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I'VE MET WITH THEM MULTIPLE TIMES.
ADAM ROSENDORFF: I DO NOT RECALL THE EXACT NUMBER.
ADAM ROSENDORFF: I DON'T RECALL THE EXACT NUMBER.
ADAM ROSENDORFF: YES, SIR.
ADAM ROSENDORFF: I -- HE'S BEEN PART OF THE GOVERNMENT TEAM ON THE OCCASIONS WHEN I'VE MET WITH THE GOVERNMENT. I'VE MADE HIS ACQUAINTANCE.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: NO, SIR.
ADAM ROSENDORFF: CAN YOU CLARIFY WHAT YOU MEAN BY "AGENTS."
MR. WADE: HAVE THERE BEEN OTHER FEDERAL AGENTS FOR EITHER THE FDA, THE U.S. POSTAL SERVICE, OR THE FBI IN ANY OF YOUR INTERACTIONS WITH THE GOVERNMENT IN THIS CASE?
ADAM ROSENDORFF: YES. INITIALLY I MET WITH THE S.E.C. I BELIEVE THERE WAS A POSTAL INSPECTOR PRESENT DURING THAT INTERVIEW, AS WELL AS AN FBI, A MEMBER OF THE FBI. I KNOW CHRIS MCCOLLOW, WHO IS A POSTAL INSPECTOR, WHO HAS BEEN VERY HELPFUL IN COORDINATING MY INTERACTIONS WITH THE GOVERNMENT.
MR. WADE: IN FACT, THOSE AGENTS HAVE BEEN PRESENT FOR MANY OF THE INTERACTIONS THAT YOU'VE HAD WITH THE GOVERNMENT; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I SEE MR. MCCOLLOW. I DON'T RECOGNIZE ANY OTHERS.
ADAM ROSENDORFF: SURE. HE'S SITTING NEXT TO MY COUNSEL, DAN KOFFMAN, TO HIS LEFT.
ADAM ROSENDORFF: WELL, DAN IS SITTING --
MR. WADE: TO YOUR RIGHT. IN THE SAME ROW THAT YOUR COUNSEL IS IN, THERE ARE TWO OTHER AGENTS SITTING THERE, AREN'T THERE?
ADAM ROSENDORFF: I DON'T RECOGNIZE THEM AS AGENTS, SIR.
ADAM ROSENDORFF: THERE WAS AN FDA REPRESENTATIVE THERE. I DO NOT RECALL HIS NAME.
ADAM ROSENDORFF: I BELIEVE SO.
ADAM ROSENDORFF: I BELIEVE SO.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I DO NOT HAVE A RECOLLECTION OF THAT.
MR. WADE: YOU GAVE THEM STATEMENTS ABOUT YOUR EXPERTISE IN ADVANCE OF AN EXPERT DISCLOSURE. DO YOU RECALL THAT?
ADAM ROSENDORFF: I REMEMBER DISCUSSING WITH MY ATTORNEYS AT THE TIME WHETHER I WAS GOING TO BE A FACT WITNESS OR AN EXPERT WITNESS. THERE WAS A ZOOM MEETING AT SOME POINT DURING COVID WHERE I DID TALK TO THE GOVERNMENT BY ZOOM.
MR. WADE: AND YOU TALKED TO THEM ABOUT ISSUES IN ADVANCE OF A DISCLOSURE THAT THEY WERE GOING TO MAKE INDICATING THAT YOU WERE GOING TO SERVE AS AN EXPERT; CORRECT?
ADAM ROSENDORFF: THEY WERE THINKING ABOUT IT. I DON'T KNOW THAT THAT WAS A DONE DEAL AT THAT POINT. THAT WAS SOMETHING THAT THEY WERE CONSIDERING.
ADAM ROSENDORFF: NO, I DO NOT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND WAS THE INFORMATION THAT YOU PROVIDED IN THESE INTERVIEWS TO THESE PROSECUTORS AND FEDERAL AGENTS TRUE, ACCURATE, AND COMPLETE?
ADAM ROSENDORFF: YES, SIR.
ADAM ROSENDORFF: I DID NOT.
ADAM ROSENDORFF: I DID NOT.
ADAM ROSENDORFF: NO, SIR.
ADAM ROSENDORFF: NO, SIR.
MR. WADE: AND I WOULD GUESS AT SOME POINT IN TIME ONE OF THESE AGENTS ADVISED YOU THAT IT'S ACTUALLY A FEDERAL CRIME TO LIE TO AN AGENT, IS IT NOT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I DO NOT RECALL THE STATUTE NUMBER. BUT I SIGNED AN AGREEMENT WITH THE GOVERNMENT ON A NUMBER OF OCCASIONS WHERE I WOULD BE GRANTED IMMUNITY FOR THE DAY, BUT MY DIRECT INTERVIEW COULD NOT BE USED AGAINST ME. THAT'S WHAT I RECALL, YEAH.
MR. WADE: AND YOUR INTERVIEW COULDN'T BE USED AGAINST YOU BECAUSE YOU WERE GRANTED -- HAVE YOU EVER HEARD OF THE TERM "QUEEN FOR A DAY"?
ADAM ROSENDORFF: I HAVE HEARD OF THAT.
ADAM ROSENDORFF: KING FOR A DAY.
ADAM ROSENDORFF: YES.
MR. WADE: AND THOSE STATEMENTS COULD NOT BE USED AGAINST YOU UNLESS YOU LIED OR CONCEALED; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I BELIEVE SO.
MR. WADE: HAS THE GOVERNMENT EVER INDICATED THAT THERE'S SOME CONCERN THAT YOU MAY BE PROSECUTED FOR HAVING LIED TO A FEDERAL AGENT?
ADAM ROSENDORFF: NO, AT NO TIME.
MR. WADE: THREE OF THE MEETINGS THAT WE DISCUSSED, THE ONES THAT OCCURRED THIS YEAR, WERE FOR PREPARATION OF YOUR TESTIMONY HERE OVER THE LAST COUPLE OF DAYS; RIGHT?
ADAM ROSENDORFF: YES, SIR.
MR. WADE: AND THEY WERE ACTUALLY SPECIFICALLY DEDICATED TO WHAT YOU WERE GOING TO DO IN THIS TRIAL; RIGHT?
ADAM ROSENDORFF: YES. YES.
ADAM ROSENDORFF: THE SEPTEMBER 13TH MEETING, I REMEMBER THE THREE GOVERNMENT LAWYERS WERE THERE, MR. MCCOLLOW WAS THERE, AND I BELIEVE AN FDA PERSON. I JUST DO NOT RECALL THE ROLL CALL OF THESE MEETINGS.
ADAM ROSENDORFF: I'M SORRY. THAT IS NOT IN VOLUME 1 IN MY BINDER.
ADAM ROSENDORFF: OKAY. I SEE IT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: OKAY.
MR. WADE: AND DOES THAT REFRESH YOUR RECOLLECTION, SIR, THAT U.S. FOOD AND DRUG ADMINISTRATION OFFICE OF INSPECTOR GENERAL SPECIAL AGENT GEORGE SCAVDIS WAS PRESENT FOR YOUR INTERVIEW?
ADAM ROSENDORFF: AS I'VE SAID, I REMEMBER THAT AN FDA REPRESENTATIVE WAS THERE. THIS DOES NOT REFRESH MY RECOLLECTION OF HIS NAME.
MR. WADE: DURING THOSE PREP SESSIONS, YOU WENT THROUGH THE QUESTIONS THAT WERE GOING TO BE ASKED BY THE GOVERNMENT AND THE ANSWERS THAT YOU WERE GOING TO GIVE; RIGHT?
ADAM ROSENDORFF: WE DISCUSSED SOME OF EXHIBITS THAT WERE POSSIBLY GOING TO BE PRESENTED. I WAS ALWAYS INSTRUCTED BY THE GOVERNMENT TO BE TRUTHFUL AND TO TELL THE TRUTH WITH REGARD TO THOSE EXHIBITS.
MR. WADE: AND DID THEY INSTRUCT YOU TO TELL THAT ANSWER WHEN I ASKED HOW YOU PREPARED IN THAT SESSION?
ADAM ROSENDORFF: NO, SIR.
MR. BOSTIC: OBJECTION, YOUR HONOR. ARGUMENTATIVE. HE NEEDS TO BE ALLOWED TO COMPLETE HIS ANSWER.
JUDGE DAVILA: YOU NEED TO LET HIM HIS ANSWER SO YOU CAN BE FULLY INFORMED AS TO YOUR NEXT QUESTION.
ADAM ROSENDORFF: IN ALL OF MY MEETINGS WITH THE GOVERNMENT, WE HAVE REVIEWED EMAILS THAT MAY OR MAY NOT BE PRESENTED AS EXHIBITS DURING THE TRIAL, AND MY INSTRUCTIONS FROM THE PROSECUTION, FROM THE GOVERNMENT, WERE TO GIVE TRUTHFUL ANSWERS DURING THE TRIAL.
BY MR. WADE:
ADAM ROSENDORFF: YES, SIR.
MR. WADE: OKAY. AND MY QUESTION TO YOU WAS NOT WHETHER THEY ASKED YOU TO GIVE TRUTHFUL ANSWERS. MY QUESTION WAS, DID THEY GO OVER THE QUESTIONS THAT THEY WERE GOING TO ASK YOU IN THESE PREP SESSIONS, YES OR NO?
ADAM ROSENDORFF: MANY OF THEM, YES.
MR. WADE: AND DID THEY GO OVER AND DID YOU DISCUSS THE ANSWERS THAT YOU WERE GOING TO GIVE IN RESPONSE TO THOSE QUESTIONS?
ADAM ROSENDORFF: DURING THE PREP SESSIONS, THE GOVERNMENT ASKED ME QUESTIONS REGARDING THE EMAILS AND I GAVE THEM ANSWERS. THERE WAS NO EXPECTATION OR PRESSURE ON ME TO GIVE A SPECIFIC ANSWER. I WAS MERELY INSTRUCTED TO TELL THE TRUTH.
MR. WADE: AND AGAIN, SIR, THAT WASN'T MY QUESTION. MY QUESTION WAS, DID YOU DISCUSS WITH THE GOVERNMENT THE ANSWERS THAT YOU WERE GOING TO GIVE IN THIS TRIAL, YES OR NO?
ADAM ROSENDORFF: I ANSWERED THE GOVERNMENT'S QUESTIONS DURING THOSE SESSIONS. I'M NOT SURE WHAT ELSE I HAVE TO SAY ABOUT THAT, YEAH.
JUDGE DAVILA: CAN YOU ANSWER THAT QUESTION YES OR NO WITHOUT AN EXPLANATION?
BY MR. WADE:
MR. WADE: WERE THERE EVER INSTANCES IN WHICH YOU DIDN'T RECALL SOMETHING AND THE GOVERNMENT HELPED REFRESH YOUR RECOLLECTION AS TO A SPECIFIC DATE OR A SPECIFIC EVENT?
ADAM ROSENDORFF: NO, THEY DID NOT CORRECT ME IF I MADE A MISTAKE ABOUT A DATE. YOU KNOW, ONE EXAMPLE WOULD BE THE DATE OF THE ROLLOUT. I REMEMBER THAT DATE. THE GOVERNMENT DIDN'T HAVE TO REFRESH MY RECOLLECTION ABOUT THAT.
MR. WADE: OKAY. WELL, LET'S LOOK AT THAT. LOOK ON PAGE 3 OF THAT SAME DOCUMENT. AND MY QUESTION TO YOU, SIR, IS THIS, WAS YOUR RECOLLECTION ON THAT LAUNCH DATE BASED UPON YOUR REVIEW OF DOCUMENTS IN THAT INTERVIEW?
MR. WADE: YOU DID NOT IDENTIFY THE LAUNCH DATE WITH WALGREENS AS SEPTEMBER 9TH, 2013 FROM YOUR REVIEW OF THE DOCUMENTS?
ADAM ROSENDORFF: YES.
MR. WADE: AND LOOKING AT PAGE 3 OF THIS EXHIBIT, THIRD PARAGRAPH, FIRST SENTENCE, THAT DOESN'T REFRESH YOUR RECOLLECTION AS TO WHETHER YOU IDENTIFIED THE THERANOS LAUNCH WITH WALGREENS AS SEPTEMBER 9TH, 2013 FROM YOUR REVIEW OF DOCUMENTS?
ADAM ROSENDORFF: I BELIEVE I HAD AN INDEPENDENT RECOLLECTION OF THAT.
MR. WADE: THE LAST PREP SESSION THAT YOU HAD WITH THE GOVERNMENT WAS THE THURSDAY NIGHT BEFORE YOU CAME IN TO TESTIFY IN THIS TRIAL; RIGHT?
ADAM ROSENDORFF: RIGHT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES, I BELIEVE SO.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YEP.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND THE FIRST SUBSTANTIVE QUESTION THAT YOU WERE ASKED WAS ABOUT WHY YOU LEFT THERANOS. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES, SIR.
MR. WADE: OKAY. LET'S LOOK AT EXHIBIT 11439. WOULD YOU TURN YOUR ATTENTION AND COUNSEL'S ATTENTION TO 1702. NOW, SIR, AGAIN YOU WERE ASKED FOUR QUESTIONS. THE FIRST QUESTION WAS, WERE YOU AT ONE TIME EMPLOYED BY A COMPANY CALLED THERANOS AND YOU SAID YES?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THEN YOU WERE ASKED YOUR POSITION AT THE COMPANY AND YOU SAID YOU WERE A LAB DIRECTOR.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THEN YOU WERE ASKED ABOUT THE APPROXIMATE DATES OF YOUR EMPLOYMENT AND YOU GAVE THEM?
ADAM ROSENDORFF: YES.
MR. WADE: AND THEN THE FIRST SUBSEQUENT QUESTION YOU WERE ASKED, THE FIRST QUESTION IN YOUR EXAMINATION WAS, WHAT WAS YOUR REASON FOR LEAVING THE COMPANY; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU GAVE FOUR REASONS. YOU SAID THERE WERE MANY FACTORS. ONE WAS THE UNWILLINGNESS OF MANAGEMENT TO PERFORM PROFICIENCY 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. THAT'S WHAT YOU TESTIFIED, RIGHT, SIR?
ADAM ROSENDORFF: YES, SIR.
ADAM ROSENDORFF: THE GOVERNMENT DID ASK ME WHY I LEFT THE COMPANY ON A FEW MEETINGS WITH THEM, YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND, SIR, YOU WERE PREVIOUSLY ASKED NEARLY THAT EXACT SAME QUESTION UNDER OATH SEVERAL YEARS AGO, WEREN'T YOU?
ADAM ROSENDORFF: ARE YOU REFERRING TO MY GRAND JURY TESTIMONY?
ADAM ROSENDORFF: OKAY, I HAVE THAT HERE. OH, I SEE. OKAY.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: I'D LIKE YOU TO LOOK AT 167, PAGE 167 OF THE TESTIMONY. TELL ME WHEN YOU HAVE THAT IN FRONT OF YOU, SIR.
ADAM ROSENDORFF: I HAVE IT.
MR. WADE: AND I'D LIKE TO DIRECT YOUR ATTENTION ON PAGE 167 TO LINE 11. YOU WERE ASKED, "AND WHY DID YOU STOP WORKING AT THERANOS?" AND YOUR ANSWER WAS, "I WASN'T SATISFIED THAT MANAGEMENT HAD RESPONDED TO MY COMPLAINTS REGARDING PROFICIENCY TESTING." RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THEN YOU WERE ASKED, "DID YOU HAVE ANY OTHER CONCERNS THAT PRECIPITATED YOUR RESIGNATION?" AND YOU ANSWERED, "THAT WAS THE MAIN ONE." RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THEN YOU WERE ASKED, "WERE THERE SMALLER CONCERNS THAT YOU HAD IN ADDITION TO THE MAIN ONE?" AND YOU SAID NO; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: I'D LIKE YOU TO TURN IN THAT BINDER TO EXHIBIT 11439. DO YOU HAVE THAT IN FRONT OF YOU, SIR?
ADAM ROSENDORFF: YES.
MR. WADE: AND THIS IS WHAT IS REFERRED TO AS AN ERRATA SHEET; CORRECT? HAVE YOU EVER HEARD THAT TERM?
ADAM ROSENDORFF: ERRATA?
MR. WADE: IT'S A SHEET THAT YOU SIGN AFTER YOU GET A CHANCE TO REVIEW YOUR DEPOSITION; IS THAT RIGHT?
ADAM ROSENDORFF: I'M NOT FAMILIAR WITH THE LEGAL TERM.
MR. BOSTIC: APOLOGIES. I WONDER IF THERE'S A MISSTATEMENT.
JUDGE DAVILA: 11439. I BELIEVE THAT'S A TRANSCRIPT.
MS. TREFZ: 11000A.
ADAM ROSENDORFF: NO, I DO NOT.
ADAM ROSENDORFF: I DO NOT SEE IT IN THE OTHER BINDER.
MR. WADE: CAN WE BRING UP THE EXHIBIT, PLEASE, ELECTRONICALLY ONLY FOR THE WITNESS AND THE COURT AND COUNSEL?
COURT CLERK: COUNSEL WILL NEED TO TURN OFF THEIR MONITORS.
ADAM ROSENDORFF: IT'S MARKED 11000A.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. BOSTIC: OBJECTION, YOUR HONOR, UNDER 613.
JUDGE DAVILA: THIS IS THE SIGNATURE DOCUMENT?
JUDGE DAVILA: WHY DON'T YOU? WHY DON'T YOU?
BY MR. WADE:
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND IT ASKS YOU TO CERTIFY UNDER THE PENALTY OF PERJURY UNDER THE LAWS OF THE STATE OF CALIFORNIA --
JUDGE DAVILA: MR. WADE, YOU DON'T HAVE TO -- IT HASN'T BEEN ADMITTED YET. THIS IS FOUNDATION FOR --
JUDGE DAVILA: RIGHT. BUT BY SAYING WHAT THE EXHIBIT IS, YOU'RE IN ESSENCE ADMITTING THE EXHIBIT. I THINK THE FOUNDATION IS -- I THINK YOU WERE TALKING ABOUT A PRIOR DEPOSITION, AND MAYBE YOU COULD RELAY HOW THIS RELATES TO THE DEPOSITION.
MR. WADE: THIS DOCUMENT RELATES TO THAT DEPOSITION THAT WE WERE JUST -- THAT I JUST SHOWED YOU; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THIS DOCUMENT IS A DOCUMENT WHERE YOU CERTIFY THE ACCURACY OF THAT DEPOSITION; RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 11000A WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: LET'S BLOW UP THE TOP OF THAT DOCUMENT. AND HERE IT SAYS THAT YOU CERTIFY UNDER THE PENALTY OF PERJURY UNDER THE LAWS OF THE STATE OF CALIFORNIA THAT THE FOREGOING IS TRUE AND CORRECT; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I REVIEWED THE TRANSCRIPT, YES.
MR. WADE: OKAY. LET'S GO TO THE SECOND PAGE. DO YOU SEE ON THE SECOND PAGE AT THE TOP YOU MAKE SEVERAL CORRECTIONS TO THE TRANSCRIPT; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: YOU DIDN'T CORRECT OR CLARIFY THE TESTIMONY THAT I JUST ASKED YOU ABOUT A COUPLE MINUTES AGO, DID YOU?
JUDGE DAVILA: YES.
BY MR. WADE:
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE ASKED A LOT OF QUESTIONS ABOUT DOCUMENTS WITHIN THAT BINDER DURING YOUR DIRECT EXAMINATION. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND I REALIZED OVER THIS WEEKEND THIS BINDER IS IN APPROXIMATELY CHRONOLOGICAL ORDER, BUT YOU WERE NOT ASKED ABOUT THESE DOCUMENTS IN CHRONOLOGICAL ORDER, WERE YOU?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: NO, THEY DID NOT.
MR. WADE: AND THEY DIDN'T SHOW YOU THE REGULATIONS THAT RELATED TO YOUR RESPONSIBILITY WITHIN THE LAB, DID THEY?
ADAM ROSENDORFF: NO, THEY DID NOT.
MR. WADE: AND AS THEY JUMPED FROM DOCUMENT TO DOCUMENT AND DREW YOUR ATTENTION TO A PARAGRAPH, THE OVERARCHING PRINCIPLE WAS THAT THEY WANTED YOU TO OFFER AND EXPLAIN YOUR CONCERNS WITH RESPECT TO A PARTICULAR ITEM IDENTIFIED IN THE DOCUMENT; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DON'T RECALL THEM ASKING ME ABOUT CONCERNS ABOUT DR. YOUNG. CAN YOU CLARIFY YOUR QUESTION? I'M SORRY.
MR. WADE: WELL, THERE WERE MANY INSTANCES IN WHICH THEY TRIED TO GET YOU TO EXPRESS CONCERNS ABOUT THINGS THAT DR. YOUNG WAS DOING; RIGHT?
MR. BOSTIC: OBJECTION. ARGUMENTATIVE.
JUDGE DAVILA: SUSTAINED AS TO THE FORM OF THE QUESTION.
BY MR. WADE:
ADAM ROSENDORFF: YES.
MR. WADE: AND DO YOU RECALL INSTANCES IN WHICH YOU WERE ASKED QUESTIONS ABOUT MR. BALWANI'S WORK?
ADAM ROSENDORFF: YES.
MR. WADE: AND DO YOU HAVE -- DO YOU RECALL QUESTIONS WHERE YOU WERE ASKED CONCERNS -- OR ASKED QUESTIONS ABOUT MR. HOLMES'S WORK?
ADAM ROSENDORFF: MS. HOLMES OR --
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND MANY OF THE QUESTIONS PROMPTED ANSWERS WHERE YOU WERE CRITICIZING THEM FOR THINGS RELATING TO THE LAB; RIGHT?
ADAM ROSENDORFF: I WAS ASKED WHETHER THESE INDIVIDUALS HAD THE APPROPRIATE BACKGROUND TO BE MAKING THESE DECISIONS THAT THEY WERE, AND I RESPONDED THAT THEY WERE NOT.
MR. WADE: DR. ROSENDORFF, YOU WERE THE CLIA LAB DIRECTOR FROM SEPTEMBER 2013 UNTIL NOVEMBER OF 2014; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND DURING THAT TIME, YOU WERE THE HIGHEST AUTHORITY UNDER THE FEDERAL REGULATIONS WITHIN THAT LAB; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: FEDERAL CLIA REGULATIONS MAKE YOU -- MADE YOU LEGALLY RESPONSIBLE FOR ALL OF THE CRITICALLY IMPORTANT FUNCTIONS OF CLIA LAB OPERATIONS; RIGHT?
ADAM ROSENDORFF: YES.
JUDGE DAVILA: YES. DO YOU HAVE THIS?
MR. BOSTIC: I'M NOT SURE, YOUR HONOR. WHICH VOLUME?
MR. BOSTIC: YES, YOUR HONOR.
BY MR. WADE:
COURT CLERK: THAT EXHIBIT NUMBER AGAIN, COUNSEL, PLEASE.
ADAM ROSENDORFF: I HAVE IT.
BY MR. WADE:
ADAM ROSENDORFF: YES.
MR. WADE: AND WHEN I SAY THAT YOU'RE RESPONSIBLE FOR THE FEDERAL CLIA LAB REGULATIONS, YOU ACTUALLY HAVE TO KNOW ESSENTIALLY ALL OF THESE REGULATIONS AS IT RELATES TO THE FUNCTION OF THE LAB FOR WHICH YOU'RE THE LAB DIRECTOR; RIGHT?
ADAM ROSENDORFF: I HAVE TO BE AWARE OF THE LABORATORY DIRECTOR RESPONSIBILITIES AND TO EXECUTE ON THOSE. THAT'S THE MAJOR FOCUS. I CAN'T TESTIFY THAT I'M AWARE OF EVERY SINGLE REGULATION IN THIS BINDER.
MR. WADE: WE'LL GET TO THE LAB DIRECTOR RESPONSIBILITIES. BUT YOU FREQUENTLY CONSULT THESE MATERIALS WHEN YOU'RE RUNNING A LAB; RIGHT?
ADAM ROSENDORFF: YES.
MR. BOSTIC: OBJECTION. RELEVANCE, YOUR HONOR.
JUDGE DAVILA: YOU'RE SEEKING TO ADMIT THE ENTIRETY OF THE DOCUMENT?
JUDGE DAVILA: I KNOW WHAT THEY ARE. AND THEY ARE HOW MANY PAGES? 122?
JUDGE DAVILA: IT WILL BE ADMITTED. OBJECTION OVERRULED.
(DEFENDANT'S EXHIBIT 7603 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: JUST SO THE RECORD IS CLEAR, YOU HAD GENERAL FAMILIARITY TO THE EXTENT THAT YOU NEEDED TO KNOW ABOUT A REGULATION IN DOING YOUR RESPONSIBILITIES AS LAB DIRECTOR IN THE LAB; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND UNDER THESE REGULATIONS, YOU WERE THE PERSON WHO WAS RESPONSIBLE FOR ENSURING THAT TESTS THAT WERE OFFERED WERE VERIFIED AND VALIDATED?
ADAM ROSENDORFF: CORRECT.
MR. WADE: YOU WERE THE PERSON WHO WAS RESPONSIBLE FOR ENSURING THE ACCURACY AND RELIABILITY OF PATIENT RESULTS?
ADAM ROSENDORFF: CORRECT.
MR. WADE: YOU WERE THE INDIVIDUAL WHO WAS REQUIRED TO ENSURE THAT THE TEST METHODOLOGY SELECTED HAD THE CAPABILITY OF PROVIDING THE QUALITY OF RESULTS THAT ARE REQUIRED FOR PATIENT CARE; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: YOU WERE THE INDIVIDUAL WHO IS REQUIRED TO ENSURE LAB PERSONNEL WERE PERFORMING THE TEST METHODS AS REQUIRED FOR ACCURATE AND RELIABLE RESULTS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND YOU UNDERSTOOD THAT IF YOU FAILED TO DISPATCH THOSE OBLIGATIONS, YOU COULD FACE SERIOUS CONSEQUENCES, RIGHT, SIR?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CAN I MAKE A CLARIFYING STATEMENT?
JUDGE DAVILA: DO YOU NEED TO CLARIFY YOUR ANSWER?
ADAM ROSENDORFF: I --
JUDGE DAVILA: DO YOU NEED TO CLARIFY YOUR ANSWER?
ADAM ROSENDORFF: YES. I ENDEAVORED EARNESTLY TO FULFILL THE LABORATORY DIRECTOR OBLIGATIONS. I FACED CONSTRAINTS AND PUSHBACK FROM MANAGEMENT.
JUDGE DAVILA: I THINK IT WAS RESPONSIVE TO HIS ANSWER. YOU CAN CERTAINLY PROBE THAT AS WELL. OVERRULED.
MR. WADE: MY QUESTION WAS, YOU UNDERSTOOD THAT IF YOU FAILED TO DISPATCH YOUR OBLIGATIONS, YOU COULD FACE SERIOUS CONSEQUENCES?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: YOU COULD EVEN IN SOME CASES LOSE YOUR LICENSE TO PRACTICE -- TO BE A LAB DIRECTOR; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND YOU ONLY HAD THE ABILITY TO HOLD THAT IMPORTANT JOB AS LAB DIRECTOR BECAUSE OF YOUR SPECIALIZED TRAINING; RIGHT?
ADAM ROSENDORFF: NO. IN TERMS OF THE LABORATORY DIRECTOR'S RESPONSIBILITIES -- I DON'T KNOW IF YOU WANT ME TO GO INTO THIS. YOU EITHER HAVE TO BE AN M.D., A D.O., OR A PH.D. AND SOME EXPERIENCE MANAGING LABS. AND FOR PH.D.'S, THERE ARE BOARDS THAT YOU HAVE TO PASS, BE CERTIFIED BY VARIOUS BOARDS TO BE A LABORATORY DIRECTOR, AND THAT'S ALL SPELLED OUT IN THE REGULATIONS.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND BECAUSE YOU WERE AN M.D., YOU WERE ABLE TO SERVE AS A LABORATORY DIRECTOR, ALONG WITH THOSE OTHER QUALIFICATIONS; RIGHT?
ADAM ROSENDORFF: FOR AN M.D. I BELIEVE IT'S A YEAR OF LABORATORY EXPERIENCE IN A HIGH COMPLEX LABORATORY THAT IS REQUIRED.
MR. WADE: RIGHT. AND I BELIEVE MY QUESTION WAS IT'S BECAUSE OF YOUR SPECIALIZED TRAINING THAT YOU QUALIFIED AND WERE ABLE TO SERVE AS LAB DIRECTOR; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: ABSOLUTELY.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND SO, SIR, IN LIGHT OF YOUR TESTIMONY, I HAVE TO ASK YOU DIRECTLY AND SQUARELY, DID YOU FAITHFULLY DISPATCH YOUR LEGAL OBLIGATIONS AS LAB DIRECTOR AT THERANOS?
ADAM ROSENDORFF: YES, I DID.
MR. WADE: DID YOU OFFER TESTS, LAB TESTS THAT YOU KNEW AT THE TIME WERE INACCURATE OR UNRELIABLE?
ADAM ROSENDORFF: NO. WHENEVER TESTS WERE INACCURATE OR UNRELIABLE, I ORDERED THE LABORATORY TO CEASE TESTING OR MOVE TO AN FDA APPROVED TEST, AND I RAISED MY CONCERNS TO MANAGEMENT. WHENEVER THERE WAS AN ISSUE OF PATIENT HARM OR PATIENT CARE, I STEPPED IN VERY AGGRESSIVELY TO DISPATCH MY OBLIGATIONS AS A PHYSICIAN.
MR. WADE: THANK YOU, SIR. SO YOU NEVER OFFERED TESTS THAT YOU THOUGHT WERE INACCURATE AND UNRELIABLE WHEN YOU WERE SERVING AS LAB DIRECTOR AT THERANOS; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND DID YOU EVER PROVIDE PATIENT TEST RESULTS THAT YOU KNEW WERE INACCURATE OR UNRELIABLE AT THE TIME THAT YOU PROVIDED THEM?
ADAM ROSENDORFF: NO. THERE'S NO WAY TO DEFINITIVELY KNOW ON A TEST BY TEST BASIS WHETHER A TEST IS UNRELIABLE.
MR. WADE: I UNDERSTAND, SIR. I'M JUST ASKING THE QUESTION WHETHER YOU KNEW -- LET ME TRY AGAIN. I'M JUST LOOKING FOR AN ANSWER FROM MY QUESTION. AND THE FIRST RELATES TO THE ASSAY -- LET ME INQUIRE, THE ASSAYS THAT WERE OFFERED IN THE LAB, OKAY, THE TYPES OF TESTS THAT YOU WERE OFFERING --
ADAM ROSENDORFF: YES.
MR. WADE: -- DID YOU EVER USE A TEST ON PATIENTS THAT YOU BELIEVED WAS INACCURATE AND UNRELIABLE?
MR. WADE: AND WITH RESPECT TO THE RESULTS THAT YOU PROVIDED TO PATIENTS, DID YOU EVER PROVIDE TEST RESULTS THAT YOU KNEW TO BELIEVE WERE INACCURATE AND UNRELIABLE AT THE TIME THAT THOSE TEST RESULTS WERE TRANSMITTED?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: THERE WERE NUMEROUS INSTANCES, AS I PREVIOUSLY TESTIFIED, WHEN I ORDERED THE TESTS SHOULD BE RUN ON THE FDA INSTRUMENTS, BUT THOSE ORDERS WERE IGNORED.
MR. WADE: SIR, DO YOU RECALL IN THAT DEPOSITION THAT WE PREVIOUSLY LOOKED AT THAT YOU WERE ASKED, "AND YOU WERE NEVER TOLD BY MR. BALWANI TO REPORT A FALSE RESULT, RIGHT?" AND YOU ANSWER "CORRECT?"
ADAM ROSENDORFF: THAT'S WHAT I JUST SAID.
MR. WADE: OKAY. I JUST WANT TO MAKE SURE IT'S CLEAR. IF YOU HAD COME TO A CONCLUSION THAT RESULTS FROM AN ASSAY SHOULD NOT BE USED, THEN YOU HAD AN OBLIGATION TO TAKE THAT TEST DOWN; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THERE WERE OCCASIONS, AS YOU TESTIFIED, THAT YOU DID PAUSE OR DISCONTINUE THE USE OF ASSAYS ON CERTAIN ITEMS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: THE STANCE OF THE COMPANY WAS THAT WHENEVER POSSIBLE WE SHOULD USE THERANOS METHODS AND DEVICES.
MR. WADE: RIGHT. BUT YOU JUST TESTIFIED THAT ONLY IF IT WAS ACCURATE AND RELIABLE WHEN IT WAS BEING OFFERED; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: RIGHT.
ADAM ROSENDORFF: YES.
MR. WADE: AND WITH RESPECT TO THE OPERATIONS OF THE LAB, YOU WERE THE PERSON WHO WAS RESPONSIBLE FOR ENSURING COMPLYING OPERATIONS IN THE LAB; RIGHT?
ADAM ROSENDORFF: ME AND THE QUALITY DIRECTOR, YES. ULTIMATELY I WAS RESPONSIBLE, AND I DELEGATED SOME OF THOSE RESPONSIBILITIES TO THE QUALITY MANAGER.
MR. WADE: AND AS A LAB DIRECTOR, YOU HAVE THE ABILITY TO DELEGATE RESPONSIBILITIES TO QUALIFIED PEOPLE; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THOSE FEDERAL REGULATIONS IN 7603, THEY SET FORTH THE SPECIFIC QUALIFICATIONS THAT PEOPLE HAVE TO HAVE WITH RESPECT TO IMPORTANT JOBS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THE PEOPLE WHO PERFORM THOSE FUNCTIONS, LIKE QUALITY MANAGER, THEY MET THOSE REQUIREMENTS; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES. I WAS MONITORING THE PERFORMANCE OF THE SUPERVISORS OF THE QUALITY MANAGER, YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: HE GAVE ME MONTHLY QC REPORTS, AND THERE WERE WEEKLY MEETINGS WITH THE ENTIRE CLIA GROUP.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND IT WAS YOUR RESPONSIBILITY TO ENSURE THAT PROFICIENCY TESTING OR AAP WAS PERFORMED IN REQUIRED INTERVALS; RIGHT?
ADAM ROSENDORFF: YES. BUT IF THE RESOURCES PERSONNEL AND DIRECTION FROM MANAGEMENT DOES NOT SUPPORT ME, THAT ISN'T POSSIBLE.
MR. WADE: WE'LL TALK ABOUT AAP AND PT MORE SPECIFICALLY LATER. BUT MY QUESTION FOR NOW IS, ULTIMATELY THAT IS YOUR RESPONSIBILITY, RIGHT, SIR?
ADAM ROSENDORFF: YES. I THINK I'VE TESTIFIED PREVIOUSLY THAT THE TESTING PLATFORM WAS NOT ALLOWING ME TO EXECUTE MY RESPONSIBILITIES AS LABORATORY DIRECTOR EFFECTIVELY. THAT WAS ONE OF THE REASONS WHY I QUIT.
JUDGE DAVILA: THAT LAST RESPONSE IS STRICKEN AS NONRESPONSIVE. I'M SURE WE'LL HAVE OTHER QUESTIONS FOR YOU.
BY MR. WADE:
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THERE'S SPECIFIC EDUCATION LEVELS AND TRAINING THAT ARE REQUIRED TO MEET THOSE -- TO BE QUALIFIED TO PERFORM THOSE FUNCTIONS?
ADAM ROSENDORFF: YES.
MR. WADE: AND ONE OF YOUR JOBS AS LABORATORY DIRECTOR IS TO ENSURE THAT THE PEOPLE WHO ARE DOING THOSE JOBS ARE QUALIFIED?
ADAM ROSENDORFF: CORRECT.
MR. WADE: IF YOU COULD LOOK WITHIN 7603 AT 493.1147. IF IT'S EASIER, IT'S ALSO SEPARATE IN YOUR BOOK UNDER 7603D. IF IT'S EASIER TO LOOK AT, IT'S THE SAME MATERIAL.
ADAM ROSENDORFF: COULD YOU TELL ME WHAT THE HOLMES NUMBER IS ON THAT PAGE?
BY MR. WADE:
ADAM ROSENDORFF: I HAVE 7603D.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. HOLMES NUMBER 793. YOUR HONOR, WE INCLUDED THIS AS AN EXCERPT FOR CONVENIENCE. IT'S A SMALLER DOCUMENT. IF THERE'S NO OBJECTION, WE'LL PUBLISH THIS VERSION.
MR. BOSTIC: IF THIS IS INCLUDED IN 7603, NO OBJECTION.
JUDGE DAVILA: I THINK IT IS. GO RIGHT AHEAD.
MR. WADE: DO YOU SEE WHERE IT SETS FORTH THE STANDARD FOR TECHNICAL SUPERVISOR QUALIFICATIONS? DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND GENERALLY, WHAT IS REQUIRED TO BE A TECHNICAL SUPERVISOR WITHIN A HIGH COMPLEXITY CLIA LAB?
ADAM ROSENDORFF: YOU NEED TO HAVE A BACHELOR'S OR HIGHER DEGREE IN A RELEVANT SUBJECT, SUCH AS CLINICAL LABORATORY MEDICINE OR BIOLOGY. YOU NEED TO HAVE SOME YEARS OF EXPERIENCE WORKING IN A CLINICAL LABORATORY.
ADAM ROSENDORFF: I BELIEVE SHE DROPPED OUT OF STANFORD AT THE AGE OF 19.
MR. WADE: AND BASED ON YOUR UNDERSTANDING OF HER BACKGROUND, WOULD SHE QUALIFY TO BE A TECHNICAL SUPERVISOR IN A CLIA LAB?
ADAM ROSENDORFF: NO, SHE WOULD NOT.
MR. WADE: LET ME ASK, I THINK IT'S OBVIOUS FROM YOUR PRIOR TESTIMONY, BUT WOULD SHE BE QUALIFIED TO BE A LABORATORY DIRECTOR?
ADAM ROSENDORFF: NO, DEFINITELY NOT.
MR. WADE: LET'S GO TO HOLMES PAGE 800. IF WE CAN HIGHLIGHT THE HEADING ON THAT PAGE. DO YOU SEE THAT SETS FORTH THE TECHNICAL SUPERVISOR'S RESPONSIBILITIES?
ADAM ROSENDORFF: YES.
MR. WADE: AT A HIGH LEVEL COULD YOU EXPLAIN FOR US WHAT A TECHNICAL SUPERVISOR DOES WITHIN A LAB?
ADAM ROSENDORFF: THEY ARE RESPONSIBLE FOR THE TECHNICAL ASPECTS OF TESTS, RUNNING OF TESTS. THEY ALSO OVERSEE PROFICIENCY TESTING, THAT THE LIMS SYSTEM IS WORKING CORRECTLY. THEY'RE INVOLVED IN THE TECHNICAL ASPECTS OF THE LABORATORY.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I BELIEVE WE DID. I DON'T RECALL WHO THAT WAS.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: THEY HAVE TO BE QUALIFIED AS A LABORATORY DIRECTOR OR BE A DOCTOR OF MEDICINE, DOCTOR OF OSTEOPATHY, AND LICENSED IN THE STATE IN WHICH THEY'RE WORKING.
MR. WADE: AND WAS MS. HOLMES, WOULD SHE BE QUALIFIED IN YOUR UNDERSTANDING OF THIS REGULATION TO BE A CLINICAL CONSULTANT?
ADAM ROSENDORFF: YES.
MR. WADE: ACTUALLY, BEFORE I GET TO THAT, DID YOU HAVE A CLINICAL CONSULTANT, OR DID SOMEONE FUNCTION AS A CLINICAL CONSULTANT AT THERANOS?
ADAM ROSENDORFF: I BELIEVE I WAS -- THE LABORATORY DIRECTOR CAN ALSO FUNCTION AS THE CLINICAL CONSULTANT. YOU CAN HOLD TWO POSITIONS. I BELIEVE THAT WAS THE CASE AT THERANOS.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND IF I CAN HAVE -- MY APOLOGIES FOR INTERRUPTING YOU. IF I CAN DRAW YOUR ATTENTION TO THE NEXT COLUMN TO THE RIGHT. DO YOU SEE WHERE IT TALKS ABOUT GENERAL SUPERVISOR?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: GENERALLY THEY HAVE TO HAVE A CLINICAL LABORATORY CLS LICENSE IN CALIFORNIA; THEY HAVE TO MEET THE REQUIREMENTS FOR A LABORATORY DIRECTOR OR A TECHNICAL SUPERVISOR; OR THEY CAN BE A DOCTOR OF MEDICINE; THEY MUST HAVE AT LEAST ONE YEAR OF LAB TRAINING AND EXPERIENCE; THEY MUST QUALIFY AS TESTING PERSONNEL, ET CETERA. THERE'S A NUMBER OF REQUIREMENTS LISTED HERE.
ADAM ROSENDORFF: YES, I BELIEVE THAT WAS HODA ALAMDAR.
ADAM ROSENDORFF: CORRECT. SO IT WAS NEVER FORMALLY -- YES, UNDER CLIA LAW THOSE PEOPLE REPORT TO ME. BUT I WAS NEVER TOLD WHO MY REPORTS WERE WITHIN THE COMPANY THOUGH.
MR. WADE: I RECALL THAT TESTIMONY, SIR. DO YOU RECALL TESTIFYING PREVIOUSLY THAT THERE WERE 12 PEOPLE WHO REPORTED DIRECTLY TO YOU?
ADAM ROSENDORFF: APPROXIMATELY, YES.
ADAM ROSENDORFF: I BELIEVE SO.
ADAM ROSENDORFF: AND CAN I ADD SOMETHING HERE?
ADAM ROSENDORFF: I JUST WANT TO CLARIFY THAT SUNNY BALWANI WAS HEAVILY INVOLVED AND WAS GIVING US BOTH DIRECTIONS ON A DAILY BASIS.
ADAM ROSENDORFF: UNDER CLIA LAW, YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND I BELIEVE YOU TESTIFIED PREVIOUSLY THAT THE DOTTED LINE REPORTED DIRECTLY TO DANIEL YOUNG; RIGHT?
ADAM ROSENDORFF: I BELIEVE SO.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. DO YOU THINK -- ARE THERE EVER CIRCUMSTANCES WHERE IT'S APPROPRIATE FOR SENIOR MANAGEMENT TO HAVE DISCUSSION ABOUT A SUBORDINATE?
ADAM ROSENDORFF: I DON'T UNDERSTAND YOUR QUESTION, SIR.
MR. WADE: ARE THERE EVER -- LET ME TRY IT AGAIN. YOU UNDERSTAND THAT THERE ARE SOMETIMES PEOPLE WHO SERVE IN A CERTAIN HIERARCHY WITHIN A COMPANY; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THERE ARE SOMETIMES PEOPLE WHO ARE SUBORDINATE TO THEM, WHO ARE LOWER DOWN IN THE HIERARCHY?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. IS IT EVER APPROPRIATE FOR PEOPLE HIGHER UP IN THE HIERARCHY TO HAVE A CONVERSATION ABOUT A PERSON LOWER DOWN IN THE HIERARCHY WITHOUT INCLUDING THAT PERSON?
ADAM ROSENDORFF: NO, IT'S NOT APPROPRIATE.
ADAM ROSENDORFF: CORRECT.
MR. WADE: SO HYPOTHETICALLY, A CEO AND A PRESIDENT OF A COMPANY COULDN'T HAVE A CONVERSATION ABOUT THE PERFORMANCE OF THE CHIEF FINANCIAL OFFICER WITHOUT THE CHIEF FINANCIAL OFFICER BEING PRESENT?
ADAM ROSENDORFF: ARE YOU ASKING WHAT IS APPROPRIATE BUSINESS CONDUCT, OR ARE YOU ASKING WHAT THE COMPANY POLICY IS? OR ARE YOU ASKING ABOUT THE LAW?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: IT DOES FREQUENTLY HAPPEN THAT HIGH MANAGEMENT WILL ASK ABOUT A MIDDLE MANAGEMENT PERSON WITH A SUBORDINATE. THAT DOES HAPPEN, YES.
MR. WADE: MY QUESTION IS, ISN'T IT PERFECTLY NORMAL AND APPROPRIATE FOR SENIOR MANAGEMENT TO HAVE DISCUSSIONS ABOUT A LOWER LEVEL EMPLOYEE?
ADAM ROSENDORFF: THAT THEY WOULD HAVE THOSE DISCUSSIONS WITH THE DIRECT -- THE PERSON THAT THE EMPLOYEE REPORTED TO, RIGHT. SO IF UPPER MANAGEMENT HAD A CONCERN ABOUT SOMEBODY THAT REPORTED TO DANISE YAM, THEY WOULD ASK HER ABOUT IT. THEY WOULDN'T GO DIRECTLY TO THE SUBORDINATE.
MR. WADE: I'M NOT ASKING ABOUT THEM GOING TO THE SUBORDINATE. I'M ASKING ABOUT THEM HAVING COMMUNICATIONS WITH EACH OTHER. LET ME GIVE YOU AN EXAMPLE, OKAY?
ADAM ROSENDORFF: UH-HUH.
MR. WADE: LET'S SAY MS. HOLMES AND MR. BALWANI WANTED TO HAVE A CONVERSATION ABOUT THE FACT THAT ADAM ROSENDORFF KEPT ROTTEN FOOD IN HIS OFFICE AND IT SMELLED A LOT AND IT WAS BECOMING A PROBLEM AND PEOPLE WERE COMPLAINING AND IT BECAME A SANITARY ISSUE. COULD MS. HOLMES AND MR. BALWANI HAVE A CONVERSATION ABOUT THAT ISSUE WITHOUT INCLUDING YOU?
ADAM ROSENDORFF: THEY WOULD -- IT'S MOST APPROPRIATE THAT THEY WOULD COME TO ME FIRST, YES.
MR. WADE: THAT WASN'T MY QUESTION. MY QUESTION WAS, IS IT YOUR TESTIMONY HERE THAT IT IS INAPPROPRIATE FOR SENIOR EMPLOYEES TO HAVE DISCUSSIONS ABOUT THE PERFORMANCE AND FUNCTIONS OF A SUBORDINATE EMPLOYEE? THAT'S YOUR TESTIMONY?
ADAM ROSENDORFF: NO. SO THE EVALUATION PROCESS DIFFERS FROM COMPANY TO COMPANY. FOR INSTANCE, I WORKED AT INVITAE. THERE WERE 360 EVALUATIONS WHERE EVERYBODY GOT TO EVALUATE EVERYBODY ELSE. I'M TRYING TO BE AS RESPONSIVE TO YOUR QUESTION AS I CAN. I GUESS I'M JUST NOT GETTING IT OR -- YEAH.
ADAM ROSENDORFF: ALAMDAR.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND DID YOU EVER HAVE CONVERSATIONS WITH MR. BALWANI ABOUT MS. ALAMDAR'S PERFORMANCE OUT OF THE PRESENCE OF MS. ALAMDAR?
ADAM ROSENDORFF: I DO NOT RECALL.
MR. WADE: DID YOU EVER HAVE CONVERSATIONS WITH MR. BALWANI ABOUT THE PERFORMANCE OF ANY OF THE OTHER PEOPLE WHO REPORTED TO YOU OUTSIDE OF THE PRESENCE OF THOSE EMPLOYEES?
ADAM ROSENDORFF: I DO NOT RECALL. I WILL SAY ON MY FIRST DAY AT THE COMPANY, SUNNY FIRED ONE OF THE CLS'S WITHOUT CONSULTING ME.
JUDGE DAVILA: THAT LAST RESPONSE IS STRICKEN, LADIES AND GENTLEMEN.
BY MR. WADE:
MR. WADE: NOW, AT THE TIME YOU LEFT THE COMPANY, THERE WERE OTHER PEOPLE WORKING IN THE CLIA LAB; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND YOU HAD SIGNED OFF ON OR AGREED WITH THE HIRING OF ALL OF THE PEOPLE WHO WERE LEFT AT THE TIME YOU LEFT; RIGHT?
ADAM ROSENDORFF: NO. THERE WERE SOME INDIVIDUALS THAT WERE HIRED BEFORE I CAME ON BOARD.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I DID HAVE A PROBLEM WITH ONE EMPLOYEE THAT I RAISED TO MANAGEMENT, YES. BUT I NEVER ASKED THAT SHE BE FIRED, NO.
ADAM ROSENDORFF: CHI NGUYEN.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: AND THE REASON -- YOU HAVE AN INDEPENDENT RECOLLECTION OF IT? IT'S NOT BECAUSE YOU WERE SHOWN DOCUMENTS BY THE GOVERNMENT; RIGHT?
ADAM ROSENDORFF: YES. YES.
MR. WADE: AND THROUGHOUT THE QUESTIONING BY THE GOVERNMENT ON YOUR DIRECT TESTIMONY, THERE WERE FREQUENT DISCUSSIONS AND QUESTIONS THAT TALKED ABOUT THAT COMMERCIAL LAUNCH IN SEPTEMBER OF 2013. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: YOU WERE ASKED A QUESTION ABOUT EVENTS PRIOR TO THE COMMERCIAL LAUNCH IN SEPTEMBER OF 2013?
ADAM ROSENDORFF: YES.
MR. WADE: AND LEADING UP TO THAT COMMERCIAL LAUNCH, THE BROADER COMMERCIAL LAUNCH IN SEPTEMBER OF 2013; RIGHT?
ADAM ROSENDORFF: YES. SO SEPTEMBER 9TH, 2013, TESTING WAS OPENED UP TO FRIENDS AND FAMILY, BUT NOT TO THE GENERAL PUBLIC IF THAT'S WHAT YOU MEAN BY "BROADER."
MR. WADE: IF WE CAN -- IF I CAN DRAW YOUR ATTENTION TO PAGE 1721 OF THE TRIAL TRANSCRIPT, WHICH IS EXHIBIT 11439.
ADAM ROSENDORFF: YES, I HAVE IT.
ADAM ROSENDORFF: EXHIBIT 11711?
ADAM ROSENDORFF: I'M SORRY. I'M FINDING IT VERY DIFFICULT SWITCHING BINDERS.
MR. WADE: I'M SORRY. I'M BEING -- PAGE -- LET ME STRIKE IT AND START OVER FOR EVERYONE'S CLARITY. EXHIBIT 11439, PAGE 1711.
ADAM ROSENDORFF: OKAY.
MR. WADE: YOU WERE ASKED, "DID THERE COME A TIME WHEN THERANOS BEGAN OFFERING THESE BLOOD TESTING SERVICES?" AND YOU SAID, "RIGHT." RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE ASKED, DO YOU RECALL WHEN THAT WAS. AND IT WAS EARLY IN SEPTEMBER OF 2013. IT WAS I THINK THE 9TH OF SEPTEMBER; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. LET'S GO TO PAGE 1721, LINE 10. YOU WERE ASKED THE QUESTION, "PRIOR TO THE COMMERCIAL LAUNCH IN SEPTEMBER OF 2013, WAS THERANOS CONDUCTING ANY PATIENT TESTING?" DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THEN ON LINE 22, "AND LEADING UP TO THAT COMMERCIAL LAUNCH, THE BROADER COMMERCIAL LAUNCH IN SEPTEMBER OF 2013, WHAT WAS THE OVERALL MOOD AT THE COMPANY?" RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE ASKED SOME QUESTIONS ABOUT EXHIBITS THAT RELATED TO THAT TIME PERIOD WHEN YOU WERE GETTING READY TO LAUNCH; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE ASKED ABOUT AN EMAIL THAT RELATED TO WHETHER THERE WERE ANY GENERAL CHEMISTRY ASSAYS THAT WERE VALIDATED. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE ASKED GENERALLY ABOUT WHETHER THAT WAS CONCERNING TO YOU THAT NONE OF THEM HAD BEEN VALIDATED AS OF AUGUST 31ST, 2013; RIGHT?
ADAM ROSENDORFF: COULD YOU POINT ME TO THAT PART OF MY TESTIMONY?
MR. WADE: SURE. NO, LET'S PUT UP 3231. IT'S IN EVIDENCE. IT MIGHT COME UP ON YOUR SCREEN. THAT MIGHT BE EASIER. LET'S BLOW UP THE EMAIL IN THE MIDDLE OF THE PAGE.
ADAM ROSENDORFF: I SEE. THIS IS AN EMAIL FROM ROSE EDMONDS WHERE I WAS CC'D.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES, YES.
MR. WADE: AND THE BEGINNING OF THE EMAIL RIGHT THERE SAYS, "AS OF RIGHT NOW NONE OF OUR ASSAYS ARE COMPLETELY THROUGH VALIDATION INCLUDING CLINICAL SAMPLE TESTING WITH FINGERSTICK." RIGHT? DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU TESTIFIED THAT THIS WAS SIGNIFICANT BECAUSE IT WAS NINE DAYS BEFORE THE LAUNCH AND NONE OF THE TESTS THAT THE COMPANY WAS INTENDING TO LAUNCH HAD BEEN VALIDATED FOR PATIENT CARE. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES, I BELIEVE I SAID THAT. YES.
ADAM ROSENDORFF: I JUST WANT TO ADD THAT NO TESTS WERE IMPLEMENTED BEFORE I REVIEWED AND SIGNED OFF ON THE VALIDATION DOCUMENTS.
MR. WADE: RIGHT. BUT I BELIEVE YOU SAID ON DIRECT EXAMINATION, YOU SAID YOU WERE CONCERNED BECAUSE YOU WERE ABOUT A WEEK FROM THE LAUNCH AND NONE OF THE GENERAL CHEMISTRY ASSAYS HAD BEEN VALIDATED; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE ASKED, "IS THIS SITUATION CONCERNING TO YOU AT THIS TIME?" AND YOU SAID, "YES." RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THERE WAS BEING PRESSURE TO LAUNCH, AT THE START OF THAT COMMERCIAL LAUNCH ON SEPTEMBER 9TH; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND DO YOU RECALL YOU WERE ASKED ABOUT ANOTHER DOCUMENT DATED SEPTEMBER 29TH RELATING TO GLUCOSE AND SODIUM AND THE FACT THAT THEY WERE STILL WORKING OUT ISSUES WITH RESPECT TO THOSE TWO ASSAYS? DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES. YES.
MR. WADE: AND YOU SAID SOMETHING LIKE IT WAS CONCERNING BECAUSE IT WAS JUST DAYS BEFORE THE LAUNCH; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE ASKED ABOUT MS. HOLMES'S TESTIMONY, OR YOUR MEETING WITH MS. HOLMES. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU DESCRIBED WITH SOME DRAMA THE EVENTS, HOW SHE PHYSICALLY RESPONDED TO YOUR COMMENTS. DO YOU RECALL THAT?
ADAM ROSENDORFF: NO DRAMA. I WAS JUST MAKING OBSERVATIONS. I WAS REPORTING WHAT I OBSERVED.
ADAM ROSENDORFF: RIGHT.
ADAM ROSENDORFF: AND POTASSIUM AND GLUCOSE.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND AGAIN AND AGAIN YOU WERE ASKED ABOUT THE EVENTS LEADING UP TO THIS SEPTEMBER 9TH LAUNCH AND THE CONCERNS THAT YOU HAD BECAUSE PEOPLE WERE EXPRESSING CONCERNS IN ADVANCE OF THAT LAUNCH; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: SIR, YOU PREVIOUSLY TESTIFIED THAT THAT WAS A SOFT LAUNCH THAT WAS OPEN TO A LIMITED NUMBER OF FRIENDS AND FAMILIES; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I WAS NEVER ASKED ABOUT THE SPECIFIC PATIENTS THAT WERE BEING TESTED DURING MY DIRECT. I HAVE COMMUNICATED THAT TO THE GOVERNMENT ON OTHER OCCASIONS.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: AT LEAST ONE OCCASION.
ADAM ROSENDORFF: THAT WAS A LONG TIME AGO. I DON'T RECALL.
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: YES.
MR. WADE: LET ME DRAW YOUR -- THAT'S EXHIBIT 11002. IF I COULD DRAW YOUR ATTENTION TO PAGE 82. IF YOU CAN LET ME KNOW WHEN YOU ARE THERE.
ADAM ROSENDORFF: OKAY.
MR. WADE: OKAY. AND IF YOU COULD JUST READ TO YOURSELF LINE 16 ON PAGE 82 TO LINE 21 ON PAGE 83.
ADAM ROSENDORFF: YES.
(PAUSE IN PROCEEDINGS.)
ADAM ROSENDORFF: YES.
BY MR. WADE:
ADAM ROSENDORFF: YES, YES, 19 THROUGH 21.
MR. WADE: NO, I'M SORRY. I WANT YOU TO READ FROM LINE 16 ON PAGE 82 TO LINE 21 ON PAGE 83, THE NEXT PAGE.
ADAM ROSENDORFF: OH, I SEE. I SEE.
(PAUSE IN PROCEEDINGS.)
ADAM ROSENDORFF: YES.
BY MR. WADE:
ADAM ROSENDORFF: LINE 23 ON THE SAME PAGE?
ADAM ROSENDORFF: OKAY.
MR. WADE: AND DOES THAT REFRESH YOUR RECOLLECTION THAT YOU DISCUSSED THE SOFT LAUNCH IN YOUR GRAND JURY TESTIMONY?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES. CAN I JUST ASK YOU --
MR. WADE: I'M ASKING THE QUESTIONS HERE, SIR, AND YOU'RE GIVING THE ANSWERS. OKAY? DO YOU RECALL THAT TESTIMONY?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT. THAT DIDN'T ALLAY ANY OF MY CONCERNS THOUGH. IF YOU'RE TESTING ONE PATIENT OR A THOUSAND, IT DOESN'T MAKE A DIFFERENCE.
JUDGE DAVILA: THE LAST PORTION IS STRICKEN. HE'LL ASK YOU QUESTIONS AND JUST ANSWER HIS QUESTIONS AS BEST YOU CAN, PLEASE.
ADAM ROSENDORFF: SURE.
BY MR. WADE:
MR. WADE: AND DOES THAT REFRESH YOUR RECOLLECTION, SIR, THAT YOU TOLD THEM THAT THAT WASN'T OPEN TO THE GENERAL PUBLIC; RIGHT?
ADAM ROSENDORFF: CORRECT. CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND IS IT YOUR TESTIMONY THAT THE NATURE OF THAT SOFT LAUNCH WAS CLEAR IN YOUR PRIOR TESTIMONY? DO YOU BELIEVE THAT WAS CLEAR?
ADAM ROSENDORFF: I WASN'T SPECIFICALLY ASKED ABOUT THE SOFT LAUNCH IN MY PREVIOUS TESTIMONY.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DO NOT RECALL THE DATES AFTER SEPTEMBER 9TH WHEN THE TESTING WAS OPENED UP TO THE GENERAL PUBLIC.
MR. BOSTIC: IF COUNSEL COULD IDENTIFY WHICH BINDER THIS EXHIBIT IS IN, THAT WOULD HELP THE WITNESS.
JUDGE DAVILA: THAT WOULD HELP.
(LAUGHTER.)
JUDGE DAVILA: ONE OF THE BLACK BINDERS.
BY MR. WADE:
MR. WADE: IT'S A DOCUMENT AND IT'S ONE OF THE TWO EXHIBIT BINDERS. FOR REFERENCE, THE YELLOW BINDERS RELATE TO YOUR TESTIMONY.
ADAM ROSENDORFF: UH-HUH.
MR. WADE: AND THE BLACK BINDERS THAT ARE BEFORE YOU SHOULD HAVE DOCUMENTS IN THEM. THIS IS AN EMAIL THAT I'D LIKE TO DRAW YOUR ATTENTION TO WHICH IS 12464?
ADAM ROSENDORFF: IN THE BLACK BINDER OR THE YELLOW BINDER?
ADAM ROSENDORFF: I ONLY HAVE ONE VOLUME OF A BLACK BINDER UP HERE.
JUDGE DAVILA: YES.
ADAM ROSENDORFF: THANK YOU. 12462, SIR?
BY MR. WADE:
ADAM ROSENDORFF: ALL RIGHT. UH-HUH.
MR. WADE: DO YOU RECOGNIZE THIS AS AN EMAIL BETWEEN YOU AND MR. BALWANI RELATING TO THE PUBLIC LAUNCH OF THERANOS ON NOVEMBER -- IN NOVEMBER OF 2013?
ADAM ROSENDORFF: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 12464 WAS RECEIVED IN EVIDENCE.)
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT. IT'S THE WALGREENS IN PALO ALTO.
MR. WADE: AND THAT FIRST SENTENCE SAYS, "WE WOULD LIKE TO OPEN OUR 300 UNIVERSITY AVE. STORE TO PUBLIC THIS COMING MONDAY." RIGHT?
ADAM ROSENDORFF: RIGHT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND IT HAD PREVIOUSLY BEEN OPENED TO FRIENDS AND FAMILY OF PEOPLE OF THERANOS; IS THAT RIGHT?
ADAM ROSENDORFF: THAT'S RIGHT.
MR. WADE: AND IT HAD PREVIOUSLY -- YOU HAD TO HAVE A CERTIFICATE, A SPECIAL CERTIFICATE IN ORDER TO GO THERE AND GET A TEST?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND IT WAS A VERY LOW VOLUME OF PEOPLE WHO WERE GETTING THOSE TESTS. DO YOU RECALL THAT?
ADAM ROSENDORFF: I DO NOT RECALL THE TESTING VOLUME AT THAT TIME.
MR. WADE: DO YOU RECALL IT WAS AN AVERAGE OF ABOUT THREE PATIENTS A DAY IN ADVANCE OF THE COMMERCIAL LAUNCH?
ADAM ROSENDORFF: I DO NOT.
MR. WADE: AND IN THE SECOND SENTENCE IT SAYS, "WE FEEL CONFIDENT THAT WE CAN HANDLE ABOUT 30 SAMPLES/DAY FROM THIS LOCATION AT THIS POINT." IS THAT CORRECT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: AS I TESTIFIED JUST NOW, I DO NOT RECALL THE VOLUME THAT WAS BEING RUN PREVIOUSLY.
MR. WADE: AND IT SAYS THERE, "AND IT HAS BEEN 2 MONTHS SINCE WE HAVE BEEN OUT IN WALGREENS." RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: BECAUSE ALL OF THE TESTING THAT HAD OCCURRED BEFORE THEN WAS NOT OPEN TO THE GENERAL PUBLIC?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND DO YOU RECALL WHEN YOU TESTIFIED TO THE GOVERNMENT, TO THE GRAND JURY, YOU MADE THIS POINT TO THEM; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND IN THAT TESTIMONY, THE GOVERNMENT TRIED TO SUGGEST THAT, WELL, AT THIS TIME THE LAUNCH WAS IMMINENT; RIGHT? DO YOU RECALL THAT?
ADAM ROSENDORFF: I THINK I JUST READ THEY WERE ABOUT TO GO LIVE AND I SAW SOMETHING WHEN I WAS REVIEWING THE GRAND JURY TESTIMONY TO THAT EFFECT, YES.
MR. WADE: DO YOU RECALL YOU INITIALLY WERE ASKED SOME QUESTIONS WITH RESPECT TO THE LAUNCH; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THEN YOU CAME BACK LATER AFTER THE GRAND JURORS HAD ASKED SOME QUESTIONS AND MR. SCHENK ASKED YOU A COUPLE OF CLARIFYING QUESTIONS ABOUT THAT. DO YOU RECALL THAT?
ADAM ROSENDORFF: I RECALL AT THE END OF THE GRAND JURY PROCEEDINGS MR. SCHENK ASKED ME SOME QUESTIONS AND ONE OF THE JURORS IN THE GRAND JURY ASKED ME SOME QUESTIONS.
ADAM ROSENDORFF: I DON'T RECALL WHAT THE TOPIC WAS.
ADAM ROSENDORFF: I DO NOT HAVE THAT EXHIBIT IN MY BINDER.
ADAM ROSENDORFF: 110?
ADAM ROSENDORFF: OKAY. I HAVE IT. I HAVE IT.
JUDGE DAVILA: TO HIMSELF?
(PAUSE IN PROCEEDINGS.)
ADAM ROSENDORFF: OKAY.
BY MR. WADE:
MR. WADE: AND DOES THIS REFRESH YOUR RECOLLECTION THAT IN THE GRAND JURY YOU TESTIFIED ABOUT HOW THIS WAS A RESTRICTED LAUNCH THAT WAS ONLY OPEN TO FAMILY OR EMPLOYEES OR FRIENDS OF EMPLOYEES?
ADAM ROSENDORFF: I DON'T HAVE AN INDEPENDENT RECOLLECTION OF THIS. I'M READING IT NOW, SO I --
ADAM ROSENDORFF: I'M UNDERSTANDING THE CONTENT OF THESE PAGES TODAY. I DO NOT HAVE AN INDEPENDENT RECOLLECTION OF IT.
MR. WADE: OKAY. AND DOES READING THESE PAGES REFRESH YOUR RECOLLECTION ABOUT BEING ASKED WHETHER IT WAS SOON TO BE THAT ANYONE COULD WALK INTO THE WALGREENS IN THE 40 OR SO LOCATIONS?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: WELL, I'M READING THAT AND UNDERSTANDING THAT. AS I SAID, I DON'T HAVE AN INDEPENDENT RECOLLECTION IN MY MIND ABOUT THIS CONVERSATION.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND SO THESE DOCUMENTS FROM LATE AUGUST TO -- LET ME STRIKE THAT. DO YOU KNOW HOW MANY TESTS WERE OFFERED IN THE FRIENDS AND FAMILY LAUNCH?
ADAM ROSENDORFF: IT WAS APPROXIMATELY 30 GENERAL CHEMISTRY TESTS AND ABOUT FOUR OR FIVE EDISON TESTS. THAT'S THE VERY ROUGH FIGURE. THOSE ARE VERY ROUGH FIGURES.
ADAM ROSENDORFF: YES.
MR. WADE: -- I JUST WANT TO MAKE SURE I UNDERSTAND YOUR TESTIMONY. THE NUMBERS YOU JUST GAVE REFER TO THE SOFT LAUNCH IN SEPTEMBER OF 2013?
ADAM ROSENDORFF: YES, THAT'S CORRECT.
JUDGE DAVILA: OF COURSE.
BY MR. WADE:
ADAM ROSENDORFF: I HAVE IT. I HAVE IT.
MR. WADE: PLEASE TAKE A MOMENT TO READ THAT TO YOURSELF. AND DOES THIS DOCUMENT REFRESH YOUR RECOLLECTION AS TO AN APPROXIMATE DATE OF THE FRIENDS AND FAMILY LAUNCH BEING IN SEPTEMBER OF 2013?
ADAM ROSENDORFF: AS I TESTIFIED, I REMEMBER THAT INDEPENDENTLY, YEAH.
MR. WADE: OKAY. AND ISN'T IT THE CASE, SIR, THAT THERE WERE NO EDISON TESTS OFFERED UNTIL MUCH LATER IN TIME?
ADAM ROSENDORFF: I BELIEVE THAT EDISON TESTS WERE OFFERED AT THAT TIME.
MR. WADE: SIR, ISN'T IT TRUE THAT THROUGHOUT THE MONTH OF SEPTEMBER, THE ONLY TESTS THAT WERE OFFERED THERE WERE CBC AND HBA1C; ISN'T THAT RIGHT?
ADAM ROSENDORFF: NO. AFTER SEPTEMBER 9TH, THERE WERE GENERAL CHEMISTRY TESTS THAT WERE OFFERED USING THE SIEMENS INSTRUMENTS THAT WERE MODIFIED TO PERFORM THE LABORATORY DEVELOPED TESTS.
ADAM ROSENDORFF: OH. AT THE TIME OF LAUNCH IT WAS NOT JUST CBC AND HBA1C. IT WAS GENERAL CHEMISTRY ASSAYS, TOO, AND I BELIEVE THERE WERE SOME EDISON TESTS OFFERED AS WELL.
ADAM ROSENDORFF: I DO NOT RECALL. IN TERMS OF GENERAL CHEMISTRY, IT WAS SOMETHING LIKE A BASIC METABOLIC PANEL.
ADAM ROSENDORFF: YES.
MR. WADE: I'LL ASK YOU TO TAKE A MINUTE AND READ THIS -- READ THE EMAIL FIRST. TELL ME WHEN YOU'RE DONE READING THE EMAIL.
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: YES.
MR. WADE: ARE YOU ABLE TO REVIEW THAT? I THINK IT'S READABLE AND IN NON-NATIVE FORM. WHY DON'T YOU TAKE A MINUTE AND REVIEW THAT?
ADAM ROSENDORFF: YES. WHAT IS THE ATTACHMENT INTENDED TO SHOW OR --
ADAM ROSENDORFF: UH-HUH.
MR. WADE: YOUR HONOR, THIS IS A DOCUMENT THAT I BELIEVE WE HAVE STIPULATED IS AUTHENTIC. THE WITNESS IS NOT ON IT. BUT IT MIGHT BE EASIER TO ADMIT IT AS A BUSINESS RECORD NOW AND HAVE THE WITNESS EXPLAIN.
JUDGE DAVILA: THIS IS THE DOCUMENT AT THE END OF THE NATIVE FORMAT?
MR. BOSTIC: I WOULD OBJECT AS TO FOUNDATION. I DON'T BELIEVE A FOUNDATION HAS BEEN LAID FOR A BUSINESS RECORD.
JUDGE DAVILA: FOR THE EMAILS?
MR. BOSTIC: FOR THE EMAILS, AND SPECIFICALLY THE ATTACHMENT.
MR. WADE: I WOULD ASK UNDER, I THINK IT'S 104, IF IT CAN BE CONDITIONALLY ADMITTED. I WOULD REPRESENT TO THE COURT THAT WE CAN LAY THE FOUNDATION FOR THIS DOCUMENT.
JUDGE DAVILA: I'LL DO THAT. WE'LL ADMIT IT NOW FOR EASE OF THE PROCEEDINGS.
JUDGE DAVILA: IT CAN BE PUBLISHED.
(DEFENDANT'S EXHIBIT 7338 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: LET'S START WITH THE EMAIL. DO YOU SEE AT THE TOP OF THE EMAIL, SIR, THIS EMAIL SAYS -- ACTUALLY, LET ME GO ONE EMAIL BELOW. TWO EMAILS BELOW. JUST PULL UP THE FIRST TOP OF THE DOCUMENT. DO YOU SEE THE DOCUMENT FROM NICK MENCHEL?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: HE WAS ONE OF THE DECOYS.
ADAM ROSENDORFF: YES, I INTERACTED WITH HIM AT THERANOS.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: HE HAD A NUMBER OF DIFFERENT ROLES COORDINATING WITH THE COLLECTION SITES. I DO NOT RECALL HIS EXACT JOB DESCRIPTION.
MR. WADE: OKAY. DO YOU SEE THERE WHERE IT SAYS THE LIST, THEY'RE CREATING A LIST RELATING TO WALGREENS, THE WALGREENS VISITS?
ADAM ROSENDORFF: YES.
MR. WADE: LET'S GO UP TO THE TOP, AND DO YOU SEE THE ATTACHMENT THERE SAYS WAG VISITS 091113 TO 101713?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES. THAT'S THE DATE OF THE EMAIL AND THE DATE OF THE EXCEL SPREADSHEET IS 10/17/2013.
MR. WADE: FAIR ENOUGH. LET'S LOOK AT THE SPREADSHEET. IF WE CAN PULL IT UP. AND IF WE LOOK AT THE WAG FINGERSTICK TAB. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I BELIEVE IT WAS THE TEST THAT WAS RUN IN NORMANDY USING FLOW CYTOMETRY.
ADAM ROSENDORFF: NO EDISONS WERE USED ON CBC'S.
ADAM ROSENDORFF: SURE.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: THERE WERE DIFFERENT MACHINES USED AT DIFFERENT POINTS IN TIME TO RUN A1C. ONE OF THEM WAS CALLED THE DC ADVANTAGE. AT THIS POINT IN TIME I DO NOT RECALL HOW THE COMPANY WAS RUNNING A1C.
MR. WADE: IF WE CAN SCROLL DOWN. ACTUALLY, YOU SEE AS YOU GO ALONG THERE ARE ANYWHERE FROM 10 TO 20 TESTS, PARTICULARLY IN THE EARLY DAYS. IT'S A LITTLE -- THERE ARE A FEW MORE AND THEN IT KIND OF PETERS OUT. DO YOU SEE THAT? DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND WHEN WE GET TO THE BOTTOM, THE ONLY TESTS THAT WERE RUN ON FINGERSTICK THROUGH 9-28-2013 WERE CBC AND HBA1C; RIGHT?
ADAM ROSENDORFF: YES, THAT'S WHAT THIS SHEET INDICATES.
MR. WADE: OKAY. AND IDENTIFY FOR ME WHEN THE FIRST EDISON BASED TEST WAS RUN ACCORDING TO THIS LIST?
ADAM ROSENDORFF: 10-17-2013.
ADAM ROSENDORFF: TSH.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND IF THERE IS A TSH TEST THAT WAS RUN IN THE CLIA LAB, YOU WOULD HAVE ALREADY SIGNED THE VALIDATION REPORT FOR THAT; RIGHT?
ADAM ROSENDORFF: YES, ABSOLUTELY.
MR. WADE: AND YOU'VE TALKED ABOUT SOME TESTS THAT WERE DISCUSSED IN LATE AUGUST OR SEPTEMBER OF 2013. YOU'VE IDENTIFIED A FEW DIFFERENT TESTS, SODIUM AND POTASSIUM, AND SOME OTHERS; RIGHT?
ADAM ROSENDORFF: YES. I WAS NOT AWARE IN EARLY SEPTEMBER THAT THE LAUNCH WOULD BE RESTRICTED TO CDC AND AIC.
ADAM ROSENDORFF: RIGHT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DO. IT'S LINE 106 IN THE SPREADSHEET. IN COLUMN A, IT'S 1947 -- I'M SORRY, IT ACTUALLY BEGINS ON LINE 104. IN COLUMN A, IT'S 1478. IT'S LISTED AS CMP. THAT'S A COMPLETE METABOLIC PANEL THAT INCLUDES SODIUM.
ADAM ROSENDORFF: THAT WOULD BE RUN ON THE MODIFIED SIEMENS INSTRUMENT.
ADAM ROSENDORFF: FROM THIS SHEET OCTOBER 14TH, 2013.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: BUT IF A VALIDATION REPORT WAS ISSUED AND THE TEST WAS RUN, THAT MEANS THAT THE ISSUE YOU EXPRESSED WAS RESOLVED; RIGHT?
ADAM ROSENDORFF: NO. I HAVE TO DISAGREE WITH YOU.
ADAM ROSENDORFF: TESTIFYING TO?
MR. WADE: DO YOU RECALL TESTIFYING THAT IF THERE WAS A CONCERN THAT WAS RAISED AND A SUBSEQUENT VALIDATION REPORT WAS SIGNED BY YOU, THAT YOU HAD BEEN COMFORTED THAT THAT CONCERN HAD BEEN ADDRESSED AND IT WAS ONLY THEN THAT YOU WOULD BE WILLING TO VALIDATE AN ASSAY?
ADAM ROSENDORFF: CORRECT. CORRECT. I THOUGHT YOU WERE ASKING ME ABOUT THE RELIABILITY TESTING AFTER THE VALIDATION WAS SIGNED.
ADAM ROSENDORFF: OKAY.
MR. WADE: NOW, YOU TESTIFIED ON DIRECT ABOUT THAT MEETING WITH ELIZABETH IN ADVANCE OF THE LAUNCH?
ADAM ROSENDORFF: RIGHT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: DURING THE GRAND JURY TESTIMONY I BELIEVE.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES. YES.
ADAM ROSENDORFF: I DON'T REMEMBER EXACTLY WHAT I SAID IN THE TESTIMONY. I'D HAVE TO LOOK AT IT. BUT I KNOW I AT LEAST SPOKE ABOUT POTASSIUM. THERE WERE OTHER ISSUES THAT WERE DISCUSSED, INCLUDING THE SODIUM AND GLUCOSE.
MR. WADE: SIR, DO YOU RECALL YOUR TESTIMONY WAS THAT THE ISSUE THAT YOU RAISED WITH ELIZABETH HOLMES IN THAT MEETING WAS RELATED TO THE POTASSIUM ASSAY?
ADAM ROSENDORFF: NOT JUST THE POTASSIUM.
MR. WADE: WELL, LET'S LOOK BACK AT YOUR TESTIMONY, SIR. IF YOU CAN LOOK AT THE EXHIBIT IN THE YELLOW BINDER, 11001.
ADAM ROSENDORFF: OKAY.
MR. WADE: AND I WANT TO CLARIFY ONE THING AT THE OUTSET BEFORE WE TALK ABOUT YOUR TESTIMONY. THE POTASSIUM ASSAY WAS GOING TO BE RUN ON WHAT DEVICE?
ADAM ROSENDORFF: MODIFIED SIEMENS DEVICE.
ADAM ROSENDORFF: CORRECT.
MR. WADE: SO THIS CONVERSATION HAD NOTHING TO DO WITH THE USE OF THE EDISON 3.5 IN THE LAB; RIGHT?
ADAM ROSENDORFF: NO, IT DID NOT.
COURT CLERK: THAT EXHIBIT NUMBER AGAIN, COUNSEL. SORRY.
ADAM ROSENDORFF: I HAVE IT.
BY MR. WADE:
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND DOES THIS REFRESH YOUR RECOLLECTION? AND THIS WAS TESTIMONY THAT YOU GAVE UNDER OATH IN THAT CIVIL DEPOSITION; RIGHT?
ADAM ROSENDORFF: YES, I DID DISCUSS THE POTASSIUM ISSUES WITH ELIZABETH HOLMES.
MR. WADE: AND THAT REFRESHES YOUR RECOLLECTION; RIGHT? YOU DON'T MENTION ANY OTHER ASSAY THERE, DO YOU?
ADAM ROSENDORFF: I DON'T MENTION ANY OTHER ASSAYS.
ADAM ROSENDORFF: UH-HUH.
ADAM ROSENDORFF: CAN YOU TELL ME WHICH BINDER, ET CETERA?
MR. WADE: IT WAS ONE OF THOSE YELLOW BINDERS AND IS THAT TESTIMONY THAT YOU WERE LOOKING AT BEFORE. IT IS EXHIBIT 11002.
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I'VE READ IT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I WAS ASKED SPECIFICALLY ABOUT CONVERSATIONS WITH MR. BALWANI AND MS. HOLMES ABOUT THE POTASSIUM RESULTS.
MR. WADE: RIGHT. AND YOU WERE ASKED QUESTIONS ABOUT THAT MEETING. YOU'VE BEEN ASKED QUESTIONS ABOUT THAT MEETING. YOU'VE GIVEN TESTIMONY ON THREE DIFFERENT OCCASIONS WITH RESPECT TO MATTERS AT THERANOS, RIGHT, OUTSIDE OF THIS TRIAL?
ADAM ROSENDORFF: THE CIVIL GRAND JURY -- AND WHAT WOULD BE THE THIRD?
ADAM ROSENDORFF: I DON'T RECALL.
MR. WADE: YOU GAVE TESTIMONY IN THE ARIZONA MATTER. DO YOU RECALL THAT? WE'VE BEEN LOOKING AT THAT TESTIMONY.
ADAM ROSENDORFF: THERE WAS -- IS THAT THE COLMAN, ET AL.?
ADAM ROSENDORFF: YES.
MR. WADE: AND I CAN REFRESH YOUR RECOLLECTION WITH THE BINDERS IF YOU WOULD LIKE. BOTH TRANSCRIPTS ARE IN THE BINDERS.
ADAM ROSENDORFF: THAT'S OKAY.
ADAM ROSENDORFF: I ACTUALLY ONLY RECALL GIVING DEPOSITIONS IN THE COLMAN CASE.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: -- YOU NEVER MENTIONED ANY ASSAY THAT YOU RAISED WITH MS. HOLMES IN THAT MEETING OTHER THAN POTASSIUM IN ANY OF THOSE INTERVIEWS; ISN'T THAT RIGHT?
ADAM ROSENDORFF: I HONESTLY -- IN SEVEN MEETINGS, I DON'T HAVE AN ENCYCLOPEDIC MEMORY.
MR. WADE: YOU CAN'T REMEMBER THOSE DEPOSITIONS, BUT YOU CAN RECALL THAT YOU RAISED THOSE TWO OTHER ASSAYS IN THAT MEETING?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: NOW, IN THAT MEETING WITH MS. HOLMES IN SEPTEMBER, YOU RAISED A CONCERN ABOUT FINGERSTICK TECHNOLOGY; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND HER RESPONSE WAS WE SHOULD JUST USE THE VENOUS DRAWS IF THE FINGERSTICK IS NOT READY; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND IF THERE WERE ISSUES THAT NEEDED TO BE ADDRESSED WITH RESPECT TO THE ASSAYS THAT WERE RUN ON FINGERSTICK, YOU COULD JUST RUN THEM ON VENOUS IN THE MEANTIME?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND WE HAVE SEEN OTHER INSTANCES WHERE YOU HAVE SUGGESTED JUST THAT WHEN ISSUES AROSE IN THE LAB; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: HCG, FOR EXAMPLE. DO YOU RECALL THERE WAS AN INSTANCE WHERE YOU SAID IT SHOULD GO TO VENOUS DRAW?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: RIGHT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: AND IN THIS PARTICULAR CIRCUMSTANCE, MS. HOLMES WASN'T DIRECTING WHAT YOU HAD TO DO; RIGHT?
ADAM ROSENDORFF: NO, SHE WAS NOT IN A POSITION TO DIRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: NOW I'M SWITCHING TO A NEW TOPIC, YOUR HONOR. I WONDER WHEN THE COURT WANTED TO TAKE ANOTHER BREAK?
JUDGE DAVILA: IN ABOUT 15 MINUTES.
MR. WADE: DO YOU RECALL BEFORE THAT LAUNCH THAT YOU WERE DOING SOME WORK WITH THE R&D GROUP TO VALI -- TO BRING THE ASSAYS OVER FROM THE R&D FUNCTION TO THE CLIA FUNCTION? DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND JUST FOR THE BENEFIT -- BECAUSE THERE ARE TWO DIFFERENT LABS THAT WERE OPERATING WITHIN THERANOS; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: NO, IT DOES NOT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WOULD CONSULT WITH THEM AFTER YOU JOINED THE COMPANY FROM TIME TO TIME; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WOULD GIVE THEM INFORMATION TO HELP INFORM THE WORK THAT THEY WERE DOING SO THAT IT WOULD FACILITATE EASIER TRANSITION INTO THE CLIA LAB; RIGHT?
ADAM ROSENDORFF: YES, YES.
MR. WADE: BECAUSE YOU HAD SOME TECHNICAL EXPERTISE THAT COULD HELP INFORM THEM AS TO WHAT YOU WERE GOING TO LOOK FOR DOWN THE ROAD; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: PAUL PATEL.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: THE EDISON ASSAYS, CORRECT.
MR. WADE: WELL, SHE WAS WORKING ON A LOT OF ELISA ASSAYS, BUT THEY INCLUDED THE EDISON ASSAYS; RIGHT?
ADAM ROSENDORFF: WE NEVER HAD A TEST, SIR, THAT WAS AN ELISA ASSAY PER SE. ALL OF THE IMMUNOASSAYS WERE RUN ON THE EDISON.
MR. WADE: OKAY. AND YOU -- WE'LL COME BACK TO DISCUSS SOME OF THE IMMUNOASSAYS THAT WERE IN THE LAB LATER. BUT YOU WERE WORKING WITH THOSE FOLKS ON FACILITATING THAT TRANSITION INTO THE CLIA LAB?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND JUST SO WE'RE CLEAR, BECAUSE WE THROW A LOT OF TERMS AROUND IN THIS TRIAL ABOUT TESTS AND LABS, IT'S NOT -- CLIA REGULATIONS APPLY ONCE IT GOES INTO THE CLIA LAB; RIGHT?
ADAM ROSENDORFF: NO. CLIA SETS FORTH WHAT YOU NEED OR HOW YOU NEED TO VALIDATE A TEST BEFORE YOU START RUNNING IT ON PATIENTS. THERE ARE SPECIFICATIONS THAT HAVE TO BE DEMONSTRATED BEFORE YOU GO LIVE.
ADAM ROSENDORFF: CORRECT.
MR. WADE: RIGHT? AND ONE OF THE THINGS -- BUT MY POINT IS, SIR, BEFORE IT'S GOING TO GO INTO THE CLIA LAB, THOSE SPECIFICATIONS AREN'T APPLICABLE, RIGHT, IN R&D?
ADAM ROSENDORFF: R&D RUNS THE VALIDATION STUDIES. PROVISIONAL SOP'S ARE IN PLACE TO GUIDE HOW THOSE STUDIES ARE BEING CONDUCTED, AND THEN THERE'S SOMETHING CALLED TECH TRANSFER WHERE THE R&D TEAM TRAINS THE CLIA LABORATORY PERSONNEL ON HOW DO THE ASSAY, AND THEY'RE SIGNED OFF AS TRAINED PERSONNEL, AND THEN THE VALIDATION REPORT GETS SIGNED OFF BY THE LAB DIRECTOR AND THEN THE TEST CAN GO LIVE.
MR. WADE: AND ULTIMATELY THE JUDGMENTS AS TO WHICH TEST COULD GO FROM R&D INTO CLIA WAS YOUR CALL FUNDAMENTALLY?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. AND THERE WERE OTHER PEOPLE WHO SIGNED THE ASSAY VALIDATION REPORTS BASED UPON WORK THAT THEY HAD DONE ON THE ASSAY; RIGHT?
ADAM ROSENDORFF: YES. THEY WERE VOUCHING FOR THE, FOR THE INTEGRITY OF THE DATA.
ADAM ROSENDORFF: I RELIED UPON THEM, CORRECT.
MR. WADE: OKAY. BUT ONCE THEY CAME IN, YOU HAD TO MAKE THAT JUDGMENT AS TO WHETHER OR NOT THOSE CLIA REQUIREMENTS WERE CHECKED; RIGHT?
ADAM ROSENDORFF: THAT WAS DONE AT THE VERY BEGINNING OF THE VALIDATION PROCESS SO THAT I WOULDN'T BE ASKING FOR THINGS AFTER THE FACT, THAT WE HAD A COMPREHENSIVE PLAN IN PLACE BEFORE THE VALIDATION BEGAN.
MR. WADE: RIGHT. YOU STARTED BACK NOT LONG AFTER YOU BEGAN WORKING AT THE COMPANY ON THOSE PROJECTS, RIGHT, AND ADVISING THE R&D?
ADAM ROSENDORFF: YES, YES.
MR. WADE: AND MUCH OF THE WORK THAT THEY WERE DOING IN THE R&D GROUP WAS SPECIFICALLY DESIGNED TO FACILITATE SMOOTH TRANSITION INTO THE CLIA LAB?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES, YES.
MR. WADE: AND I'D LIKE TO SHOW YOU WHAT IS IN EVIDENCE AT 9921, WHICH IS GOING TO BE ONE OF YOUR BLACK BINDERS. WE'LL BRING IT UP ON THE SCREEN. IT'S IN EVIDENCE, AND IT MAY BE EASIER FOR YOU TO LOOK AT IT THERE. IT'S ON YOUR SCREEN. DO YOU SEE THIS IS A DOCUMENT ENTITLED MASTER VALIDATION PLAN FOR ELISA ASSAYS ON THERANOS DEVICES?
ADAM ROSENDORFF: YEAH.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I JUST WANT TO CLARIFY THAT. SO DR. GELB WAS NOT THERE WHEN I ARRIVED. THE LABORATORY DOCUMENTS WERE BEING SIGNED BY SPENCER HIRAKI. HE WAS A PH.D.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: THAT'S RIGHT. THAT'S RIGHT.
MR. WADE: OKAY. BUT YOU WERE SERVING -- WELL, DR. GELB, IN ANY EVENT, APPEARS TO HAVE SIGNED THIS DOCUMENT. DO YOU SEE THAT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND DO YOU RECALL WHETHER YOU HAD REVIEWED THIS DOCUMENT AT THE TIME? I CAN GO TO THE SECOND PAGE AND IT MIGHT HELP. THIRD PAGE.
ADAM ROSENDORFF: I DO NOT RECALL REVIEWING THIS DOCUMENT.
JUDGE DAVILA: YES.
BY MR. WADE:
MR. WADE: LET'S START WITH AN EMAIL HERE. AND YOU SEE THIS IS AN EMAIL FROM DR. GANGAKHEDKAR COPYING DR. SIVARAMAN. YOU KNEW DR. SIVARAMAN AS WELL?
ADAM ROSENDORFF: YES, I DID.
ADAM ROSENDORFF: SHARADA WAS SUREKHA'S BOSS. THEY BOTH WORKED ON THE IMMUNOASSAYS AND THE EDISONS. I THINK SHARADA LEFT AT SOME POINT AND SUREKHA TOOK OVER. I DON'T RECALL.
ADAM ROSENDORFF: AND TO ELIZABETH.
ADAM ROSENDORFF: YES.
MR. WADE: AND MS. HOLMES WAS VERY INVOLVED IN THE R&D EFFORTS. DO YOU RECALL THAT? ON THE ASSAYS?
ADAM ROSENDORFF: I HAVE SEEN EVIDENCE DURING THIS TRIAL WHERE SHE WAS COMMUNICATING WITH SUREKHA.
MR. WADE: LET ME -- WE DON'T WANT ANY EVIDENCE. WE JUST WANT YOUR KNOWLEDGE AT THE TIME. I DON'T MEAN TO BE RUDE AND INTERRUPT YOU, BUT WE JUST WANT TO KNOW WHETHER YOU WERE AWARE AT THE TIME THAT SHE WAS INVOLVED IN THE R&D?
ADAM ROSENDORFF: WHETHER MS. HOLMES WAS INVOLVED?
ADAM ROSENDORFF: I DO NOT KNOW.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND THERE ARE A COUPLE DEVELOPMENT REPORTS, AND THEN IT SAYS A VALIDATION PLAN. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. LET'S BRING UP THE FIRST -- AND IT SAYS -- I'M SORRY. IF WE CAN GO BACK TO THE EMAIL. I JUMPED THE GUN THERE. IT SAYS, "AS DISCUSSED IN THE MEETING WITH ELIZABETH, PLEASE REVIEW THE DATA IN THE DEVELOPMENT REPORTS FOR USABILITY TOWARDS VALIDATION AND PROPOSE WHAT WILL BE NEEDED FOR VERIFICATION FOR THE 3.5 SYSTEM WITH THE PRE-DILUTIONS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: ACTUALLY, THIS IS REALLY ASSAY DEVELOPMENT. THE TECH TRANSFER IS WHEN, YOU KNOW, THE R&D TEAM IS VALIDATING THE TEST AND THEY'RE TRAINING THE CLIA STAFF. THESE ARE REALLY PRELIMINARY STUDIES AS FAR AS I CAN TELL.
MR. WADE: WELL, LET'S LOOK AT THE DOCUMENT. IF WE CAN BRING UP THE FIRST ASSAY. DO YOU SEE THERE IT SAYS MASTER VALIDATION PLAN FOR ELISA ASSAYS ON THERANOS DEVICES. DO YOU SEE THAT?
ADAM ROSENDORFF: YEAH. SO ONE THING THAT DOESN'T MAKE SENSE IS THERE WAS AN ATTACHMENT THAT SAYS TSH MASTER VALIDATION PLAN, THAT WAS WHAT THE ATTACHMENT WAS ENTITLED, AND THE DOCUMENT SAYS MASTER VALIDATION PLAN, SO I DON'T KNOW WHY THERE WAS THAT DISCREPANCY.
MR. WADE: THERE WERE MULTIPLE ATTACHMENTS, AND WE CAN SPEND A LITTLE TIME WITH EACH. LET ME START WITH THIS ONE.
ADAM ROSENDORFF: UH-HUH.
MR. WADE: AND THIS IS AN ATTACHMENT. AND IF YOU HAVE ANY UNCERTAINLY, THE EXHIBIT IS IN YOUR BOOK. YOU'RE WELCOME TO LOOK AT THE PHYSICAL ATTACHMENT. BUT THIS IS ONE OF THE ATTACHMENTS. IT SAYS MASTER VALIDATION PLAN FOR ELISA ASSAYS ON THERANOS DEVICES. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THIS IS NOW THE TYPE OF FORMAT THAT WAS USED WITHIN THE CLIA LAB SETTING AT THERANOS; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THIS IS THE TYPE OF DOCUMENT, WHEN YOU'RE TALKING ABOUT VALIDATION REPORTS LATER -- AND WE'LL TALK ABOUT SOME IN A BIT -- MANY OF THEM HAVE THIS TYPE OF DOCUMENT, THIS TYPE OF COVER PAGE; RIGHT?
ADAM ROSENDORFF: YEAH. YOU CAN'T, YOU CAN'T HAVE A MASTER VALIDATION PLAN THAT WOULD APPLY TO ALL OF THE ELISA ASSAYS. THAT MAKES NO SENSE. IT'S A PURE ASSAY PLAN. THAT'S WHAT IS REQUIRED.
ADAM ROSENDORFF: UH-HUH.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: NO. THAT, THAT IS THE GREEN LIGHT FOR IT TO GO INTO VALIDATION. THE PLAN LAYS OUT HOW ARE YOU GOING TO DO YOUR VALIDATION, WHAT YOUR ACCEPTANCE CRITERIA ARE, ET CETERA. AFTER THE PLAN THERE'S A VALIDATION REPORT. THAT HAS TO BE SIGNED BY ME BEFORE TESTS CAN BE OFFERED.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YOU NEED TRAINING AND DOCUMENTATION OF TRAINING.
MR. WADE: AND ALL OF THOSE THINGS UNDER THOSE REGULATIONS IN 7603 ULTIMATELY ARE THE RESPONSIBILITY OF THE LABORATORY DIRECTOR?
ADAM ROSENDORFF: YEAH. YOU NEED TO HAVE INSTRUMENTS MAINTAINED, PERFORMANCE QUALIFICATIONS ON THE INSTRUMENTS. THERE ARE A NUMBER OF THINGS.
MR. WADE: THERE ARE A LOT OF THINGS THAT YOU NEED TO HAVE WITHIN THE FUNCTIONING OF THE CLIA LAB; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND WE'LL TALK ABOUT MANY OF THEM WITH YOU, SIR. BUT I'M FOCUSSED RIGHT NOW ON THIS INITIAL PERIOD. AND I UNDERSTAND YOUR TESTIMONY IS EVERY ASSAY HAS TO HAVE A PLAN?
ADAM ROSENDORFF: CORRECT.
MR. WADE: DO YOU RECALL THAT? DO YOU RECALL THAT FOR DIFFERENT CATEGORIES OF ASSAYS THERE WAS SORT OF AN OVERARCHING MASTER VALIDATION PLAN THAT WOULD BE USED FOR THE PROCESS TO BE USED TO CREATE THOSE INDIVIDUAL ASSAY PLANS?
ADAM ROSENDORFF: I DON'T RECALL THAT.
ADAM ROSENDORFF: I SEE THAT IT HAS MY NAME ON IT AT THE BOTTOM.
ADAM ROSENDORFF: YEAH, THIS WAS TSH MASTER VALIDATION PLAN. I'M ASSUMING THAT'S THE SAME DOCUMENT.
ADAM ROSENDORFF: ONE BLACK BINDER STARTS AT 10451.
JUDGE DAVILA: DO YOU HAVE IT?
ADAM ROSENDORFF: IT'S NOT IN HERE. THE OTHER BINDER ENDS AT 10300.
ADAM ROSENDORFF: OKAY. THANKS.
BY MR. WADE:
MR. WADE: I BELIEVE IN THAT COPY, SIR, I ONLY PRINTED ONE OF THE FOUR ATTACHMENTS. BUT WHY DON'T YOU TAKE A MINUTE AND REVIEW THAT DOCUMENT JUST GENERALLY TO FAMILIARIZE YOURSELF WITH IT. WHILE HE'S DOING IT, IF WE CAN PULL UP ON SPLIT SCREEN THAT ATTACHMENT AND 9921. SO YOU'LL RECALL A FEW MINUTES AGO WE LOOKED AT 9921. IT WAS THE DR. GELB MASTER VALIDATION PLAN --
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND THAT WAS SIGNED BY DR. GANGAKHEDKAR, DR. GELB, AND DR. YOUNG. I GUESS JUST THOSE THREE, YES?
ADAM ROSENDORFF: OH, THAT WAS WAY BACK IN 2011, YEAH.
ADAM ROSENDORFF: YEAH.
MR. WADE: AND WHY DON'T WE LOOK AT A COUPLE OF PAGES OF THAT DOCUMENT. IF YOU'LL GO TO THE THIRD PAGE. THIS IS THE DOCUMENT THAT SETS FORTH SOME PLANS AND DEFINITIONS WITH RESPECT TO HOW THE VALIDATION PROCESS WAS GOING TO PLAY OUT WITH RESPECT TO ASSAY DEVELOPMENT. LET ME GO TO THE NEXT PAGE. AND THE NEXT PAGE. AND THE NEXT PAGE. OKAY. NOW, IF YOU TURN YOUR ATTENTION BACK TO 10 -- THE ATTACHMENT AT 1031, YOU SEE IT'S VERY SIMILAR. AND IT APPEARS TO BE AN ATTEMPT TO UPDATE THAT OLD PLAN?
ADAM ROSENDORFF: YES. THIS ONE IS DATED AUGUST 2013.
ADAM ROSENDORFF: THE AUTHOR AND REVIEW AND STATEMENT ARE THE SAME -- I'M SORRY. THE PREVIOUS ONE WAS SIGNED BY DR. GELB. YOU'RE SHOWING ME THE UPDATED ONE ON THE SCREEN, AND I'M ALSO LOOKING AT IT.
ADAM ROSENDORFF: YEAH.
MR. WADE: AND I'M GOING TO FOCUS YOU ON THE ONE THAT WAS SENT TO YOU AND DR. YOUNG AND MS. HOLMES IN AUGUST OF 2013. OKAY?
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: I DO NOT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: UH-HUH.
MR. WADE: IF WE CAN GO TO THE SECOND, THIRD, RIGHT HERE. DO YOU SEE WHERE IT -- THE PURPOSE IS IDENTIFIED AS "TO DEFINE A VALIDATION PLAN FOR THE VALIDATION AND QUALIFICATION OF ELISA ASSAYS." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND IF I CAN TAKE ALL OF NUMBER 2, THE SCOPE. DO YOU SEE THAT 2.1 SAYS, "THIS DOCUMENT APPLIES TO THE VALIDATION/QUALIFICATION OF ELISA ASSAYS ON THERANOS DEVICES UNDER CLIA REGULATIONS BY CLIA LABORATORY PERSONNEL"?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES, I AM.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND THE IDEA -- THAT IS THE CLIA REGULATION THAT SETS FORTH ALL OF THE REQUIREMENTS THAT NEED TO BE MET BEFORE AN ASSAY CAN BE VALIDATED, AND THEN LATER IN THE VALIDATION DOCUMENT IN THE CLIA LAB, AND THEN OFFERED TO PATIENTS; RIGHT?
ADAM ROSENDORFF: YES. IT LISTS THE REQUIRED PERFORMANCE SPECIFICATIONS.
ADAM ROSENDORFF: YES.
MR. WADE: AND IF WE CAN GO DOWN TO THE NEXT SECTION OF THE DOCUMENT THERE AND JUST FOCUS ON THE DEFINITIONS. IT TALKS ABOUT SOME OF THOSE REQUIREMENTS AND GIVES SOME DEFINITIONS THERE?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CLSI -- I CAN DESCRIBE WHAT THAT IS.
ADAM ROSENDORFF: IT IS A PRIVATE ORGANIZATION BASED IN WAYNE, PENNSYLVANIA, THAT PUBLISHES GUIDANCE DOCUMENTS ON A NUMBER OF LABORATORY ISSUES.
MR. WADE: OKAY. AND WHY DON'T WE GO TO THE NEXT PAGE. THE NEXT PAGE, NEXT PAGE. LET'S BLOW UP 7. I'M SORRY. 6. AND THIS TALKS ABOUT THE PROCESS TO DO THAT ON THE THERANOS DEVICES; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DO NOT RECALL.
ADAM ROSENDORFF: ARE YOU ASKING ME TO VOUCH FOR THE TRUTH OF THIS STATEMENT?
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: YEAH.
MR. WADE: BUT DO YOU RECALL GENERALLY THE PROCESS THAT WAS GONE THROUGH TO MEET THOSE SPECIFICATIONS WITH RESPECT TO EACH INDIVIDUAL ASSAY?
ADAM ROSENDORFF: YES. YES.
JUDGE DAVILA: SURE. SURE. LET'S TAKE OUR AFTERNOON BREAK. FOLKS, LET'S TAKE ABOUT 20 MINUTES AND THEN WE'LL COME BACK AND FINISH OUR DAY.
(RECESS FROM 1:32 P.M. UNTIL 1:54 P.M.)
JUDGE DAVILA: ALL RIGHT. THANK YOU. WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT AGAIN. MR. WADE, WOULD YOU LIKE TO CONTINUE?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: MY TITLE WAS MEDICAL DIRECTOR OF THE CLIA LABORATORIES. MIGUEL REYES WAS ON THE CERTIFICATE AS THE CLIA DIRECTOR OF RECORD.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: LET ME DIRECT YOU TO EXHIBIT 10272. AND THEY ARE IN THE BLACK BINDERS AND THEY SHOULD BE IN NUMERICAL ORDER, DOCTOR. IT SHOULD HELP YOU LOOK AT THE TABS ON THE SIDE.
JUDGE DAVILA: IS IT VOLUME 1?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: IT IS A RESUME THAT APPEARS TO BE CURRENT DURING MY TIME AT UPMC. IT'S SINCE BEEN UPDATED.
MR. WADE: AND BASED ON THE BOOKS AND RECORDS OF THE COMPANY, THIS APPEARS TO BE THE ONE THAT YOU SENT TO THERANOS?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
JUDGE DAVILA: THERE'S AN ADDRESS THAT SHOULD BE REDACTED.
JUDGE DAVILA: SHOULD WE OUT OF CAUTION, MR. BOSTIC?
MR. BOSTIC: NO OBJECTION TO THE ADMISSION, YOUR HONOR.
JUDGE DAVILA: LET'S JUST DELETE THAT. THANK YOU, MR. WADE.
JUDGE DAVILA: AND THE PHONE NUMBERS AND ALL OF THAT.
MR. WADE: WE'LL BLOCK OUT THE WHOLE ROW BELOW A. ROSENDORFF, M.D. MAY WE PUBLISH IT, YOUR HONOR, ONCE WE GET THAT?
JUDGE DAVILA: YES.
(DEFENDANT'S EXHIBIT 10272 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: WHY DID I LEAVE?
ADAM ROSENDORFF: I GOT REALLY INTERESTED IN THE INNOVATION THAT WAS HAPPENING IN SILICON VALLEY, AND I REMEMBER READING A BIOGRAPHY OF STEVE JOBS, AND I DON'T RECALL WHO THE AUTHOR WAS. THE WHOLE KIND OF EXCITEMENT AROUND SILICON VALLEY WAS VERY COMPELLING TO ME. THAT'S THE MAJOR REASON, YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE EXCITED ABOUT TECHNOLOGY, AND THAT'S ONE OF THE REASONS THAT YOU MIGHT WANT TO MOVE OUT TO SILICON VALLEY?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: NOT THAT I CAN RECALL, NO.
ADAM ROSENDORFF: NO. I WANTED TO MAKE A MORE GLOBAL IMPACT ON HEALTH CARE AND I THOUGHT JOINING A DIAGNOSTICS COMPANY WOULD HELP ME DO THAT.
MR. WADE: OKAY. AND I BELIEVE YOU TESTIFIED THAT -- SO WHEN YOU WERE MOVING WEST AND YOU WANTED TO GET INTO TECHNOLOGY, YOU WERE -- YOU HAD SORT OF APPLE AND ITS STORY AND INNOVATION IN YOUR MIND; IS THAT FAIR?
ADAM ROSENDORFF: INNOVATION, YES, YES.
MR. WADE: AND SO YOU UNDERSTOOD MUCH OF WHAT HAD MADE APPLE SUCCESSFUL AS A RESULT OF READING THE ISAACSON BIOGRAPHY; RIGHT?
ADAM ROSENDORFF: YES, YES.
MR. WADE: AND YOU KNEW ONE OF THE THINGS THAT WAS IMPORTANT TO APPLE'S SUCCESS AND SUCCESS OF A TECHNOLOGY COMPANY WAS VERY EFFECTIVE PUBLIC RELATIONS AND MARKETING; RIGHT?
MR. BOSTIC: OBJECTION. FOUNDATION.
JUDGE DAVILA: WELL, IF HE KNOWS. CAN YOU ANSWER THAT QUESTION?
ADAM ROSENDORFF: MY PERSONAL OPINION WAS THAT IT WAS APPLE'S UNDERSTANDING OF PEOPLE'S EVERYDAY NEEDS AND TAILORING THE TECHNOLOGY TO THOSE NEEDS THAT MADE IT SUCCESSFUL.
BY MR. WADE:
MR. WADE: AND, AGAIN, WE'RE TALKING ABOUT -- BASED ON THE BOOK, YOU ARE AWARE THAT MR. JOBS SPENT A LOT OF TIME FOCUSSED ON COMMERCIALS AND OTHER PUBLIC RELATIONS; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU'RE AWARE, BASED ON THE BOOK, THAT THEY BECAME INCREDIBLY FAMOUS FOR SOME OF THE ADVERTISING THAT THEY DEVELOPED; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I RECALL A CHIAT/DAY, I BELIEVE, THERE WAS AN AD ABOUT BIG BROTHER, OR THERE WAS A REFERENCE TO GEORGE ORWELL.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DO NOT RECALL.
MR. WADE: AND AS A RESULT OF THAT, THAT HELPED GET A LOT OF ATTENTION FOR APPLE. DO YOU RECALL THAT?
ADAM ROSENDORFF: THAT WAS A VERY FAMOUS COMMERCIAL, SO I GUESS SO.
MR. WADE: AND THERE WERE ALSO -- THAT SAME FIRM THAT IS REFERENCED IN THE ISAACSON BOOK, THE CHIAT/DAY FIRM, THEY DEVELOPED THE "THINK DIFFERENT" CAMPAIGN AND IT TALKS ABOUT THAT IN THE BOOK; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU RECALL FROM THE BOOK THE INTENSE SECRECY THAT MR. JOBS IMPOSED ON R&D PROJECTS AT APPLE?
ADAM ROSENDORFF: CAN I MAKE A COMMENT ON APPLE'S SUCCESS?
ADAM ROSENDORFF: OKAY. CAN YOU REPEAT THE QUESTION?
ADAM ROSENDORFF: YEAH.
MR. WADE: OKAY. DO YOU RECALL -- DO YOU RECALL THAT THE BOOK LAYS OUT IN INTENSE DETAIL OR IN EXCRUCIATING DETAIL THE SECRECY THAT APPLE PUT IN CONNECTION WITH ITS RESEARCH AND DEVELOPMENT AND PRODUCT DEVELOPMENT EFFORTS. DO YOU RECALL THAT?
ADAM ROSENDORFF: I RECALL INTENSE SECRECY WITH REGARD TO THE PUBLIC KNOWLEDGE OF THE TECHNOLOGY, YES.
MR. WADE: DO YOU RECALL THAT THERE WERE -- AS DETAILED IN THE BOOK, THERE WERE ACTUALLY OCCASIONS WHERE MR. JOBS WOULD MOVE AN R&D PRODUCT TEAM OUT OF THE APPLE FACILITY INTO ANOTHER FACILITY, A SECRET AND UNDISCLOSED LOCATION, THAT WAS UNMARKED. DO YOU RECALL THAT?
ADAM ROSENDORFF: NO. THAT'S INTERESTING. YEAH.
MR. WADE: OKAY. DO YOU RECALL THAT WHEN MR. JOBS WOULD GO TO REVIEW TECHNOLOGY, THAT HE WOULD DO IT IN A SPECIAL PASSWORD PROTECTED ROOM WHERE NO ONE ELSE COULD ACCESS THAT TECHNOLOGY? IT WAS A ROOM SPECIFICALLY DESIGNED FOR THAT?
MR. BOSTIC: OBJECTION. RELEVANCE. FOUNDATION. COUNSEL IS TESTIFYING.
JUDGE DAVILA: HE DID READ THE BOOK, BUT THIS ISN'T THE TIME FOR A BOOK REPORT. I FAIL TO SEE THE RELEVANCE. I'LL ALLOW YOU SOME LATITUDE, BUT HE READ THE BOOK AND YOU CAN GO ON.
ADAM ROSENDORFF: YES.
MR. WADE: AND I BELIEVE YOU TESTIFIED YOU CAME OUT AND YOU INTERVIEWED FOR 20 MINUTES WITH MS. HOLMES; IS THAT RIGHT?
ADAM ROSENDORFF: ABOUT THAT, YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: THE PHRASE I USED WAS EARNESTNESS AND DEDICATION.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: THERE WAS VERY LITTLE INFORMATION AVAILABLE ON THE COMPANY WEBSITE ABOUT WHAT THEY ACTUALLY DID. I WAS ABLE TO GOOGLE AND FOUND SOME PATENTS THAT THERANOS HAD FILED --
ADAM ROSENDORFF: -- OVER THE YEARS, YEAH.
MR. WADE: OKAY. AND YOU SAID THAT THERE WAS VERY LITTLE INFORMATION. THERE WAS NOT A LOT OF PUBLIC DISCLOSURE IN THAT INFORMATION; RIGHT?
ADAM ROSENDORFF: STEALTH MODE, QUOTE-UNQUOTE.
MR. WADE: YES. AND LIKE APPLE, THEY KEPT THE SECRETS. YOU HAD JUST READ APPLE, SO IT MUST NOT HAVE BEEN SURPRISING FOR YOU TO LEARN THAT THIS TECHNOLOGY COMPANY WAS HOLDING ITS CONFIDENTIAL TRADE SECRETS CLOSELY?
ADAM ROSENDORFF: I HAD TWO THOUGHTS. ONE WAS THAT THE LACK OF INFORMATION WOULD NOT ALLOW ME TO EVALUATE THIS OPPORTUNITY AS THOROUGHLY AS I WOULD LIKE. MY OTHER THOUGHT WAS THAT THEY MUST HAVE GREAT TECHNOLOGY BECAUSE THEY'RE KEEPING IT SO SECRET, BECAUSE THEY'RE KEEPING IT SO SECRET, BECAUSE THEY'RE KEEPING THE TECHNOLOGY SO SECRET.
MR. WADE: OKAY. AND -- BUT IT WASN'T TOTALLY SECRET. THERE WERE PATENTS THAT YOU REVIEWED; RIGHT?
ADAM ROSENDORFF: CORRECT.
JUDGE DAVILA: YES.
JUDGE DAVILA: IS THIS THE PATENT BINDER?
MR. WADE: DR. ROSENDORFF, I PUT BEFORE YOU A BINDER OF THE PATENTS THAT WERE PUBLICLY AVAILABLE ON THE WEBSITE ON -- PUBLICLY AVAILABLE AS OF THE DATE OF YOUR INTERVIEW. OKAY?
ADAM ROSENDORFF: YES.
MR. WADE: AND DO YOU RECALL HOW -- AND I WANT TO HAVE THIS AS A REFERENCE FOR YOU IN CASE YOU NEED TO GO TO ANY OF THESE MATERIALS IN CONNECTION WITH MY QUESTIONS. OKAY?
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: THERE WAS NOT.
ADAM ROSENDORFF: THERE WAS A YOUTUBE VIDEO OF ELIZABETH THAT SHE WAS TALKING AT STANFORD AND IT WAS SHORTLY AFTER SHE STARTED THE COMPANY. SHE WAS A BRUNETTE BACK THEN. IT WAS AN INTERESTING TALK, YEAH.
(LAUGHTER.)
BY MR. WADE:
MR. WADE: NEVERTHELESS, BASED UPON YOUR INFORMATION, THE INFORMATION THAT YOU WERE TO GATHER AND THE PATENTS THAT YOU REVIEWED, YOU CAME TO A CONCLUSION ABOUT THE COMPANY; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: IS THAT RIGHT?
ADAM ROSENDORFF: MARKET CAP?
ADAM ROSENDORFF: I KEEP LOSING TRACK. SOMETIMES IT'S MICROSOFT. SOMETIMES IT'S APPLE. SOMETIMES IT'S GOOGLE. YOU KNOW BETTER THAN ME.
ADAM ROSENDORFF: NO. I DIDN'T GROW UP HERE.
ADAM ROSENDORFF: YES, YES.
MR. WADE: AND SO YOU CAME TO THE -- BUT YOU DID KNOW AT THE TIME -- IF YOU DIDN'T KNOW IT WAS ONE OF THE BIGGEST COMPANIES IN THE WORLD, YOU KNEW IT WAS ONE OF THE MOST SUCCESSFUL COMPANIES GOING AT THE TIME; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND BASED UPON THE HOUR OF INTERVIEWS AND THOSE PATENTS, YOU CAME TO THE VIEW THAT THIS WAS GOING TO BE THE EQUIVALENT OF THIS ICONIC CORPORATE COMPANY?
ADAM ROSENDORFF: I BELIEVED IT WAS GOING TO REVOLUTIONIZE LABORATORY TESTING.
MR. WADE: AND WERE THERE PARTICULAR PATENTS THAT CAUSED YOU TO BELIEVE THAT IT COULD REVOLUTIONIZE LABORATORY TESTING?
ADAM ROSENDORFF: YEAH. THERE WERE PATENTS RELATED TO HOW YOU COLLECT SMALL SAMPLES; THERE WERE PATENTS RELATED TO TIPS THAT WERE COAT TO THE ANTIBODIES THAT WOULD BOTH DRAW UP THE SAMPLE AND BE A DETECTION DEVICE. THERE WERE A LOT OF INTERESTING IDEAS.
MR. WADE: AND THAT WAS WHAT -- THE TECHNOLOGY THAT YOU SAW PUBLICLY AVAILABLE IN THE INTELLECTUAL PROPERTY IS WHAT CAUSED YOU TO THINK THIS COULD BE THE NEXT APPLE?
ADAM ROSENDORFF: NOT JUST THAT. I MEAN, THE IMPRESSION THAT I GOT AFTER THE INTERVIEWS, THE FACT THAT THEY WERE INTERVIEWING ME AT 6:00 P.M. SPOKE TO A CERTAIN WORTH ETHIC THERE. THE PATENTS WAS ONE FACTOR, YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: ON YOUTUBE, YEAH.
MR. WADE: OKAY. AND I THINK YOU SAID WHEN YOU CAME TO THE COMPANY, YOU DIDN'T GO ON TO THE CLIA LICENSE RIGHT AWAY; RIGHT?
ADAM ROSENDORFF: CORRECT. I NEEDED A CALIFORNIA MEDICAL LICENSE BEFORE I COULD SERVE AS LABORATORY DIRECTOR.
MR. WADE: AND SO WAS THERE A PROCESS THAT YOU HAD TO GO THROUGH TO GET THAT BEFORE YOU COULD BE THE LABORATORY DIRECTOR?
ADAM ROSENDORFF: YES. I APPLIED TO THE MEDICAL BOARD OF CALIFORNIA FOR A MEDICAL LICENSE.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DO NOT RECALL.
MR. WADE: BEFORE YOU WENT ON THE CLIA CERTIFICATE, WAS IT SPENCER HIRAKI WHO WAS ON THE CLIA CERTIFICATE?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: THERE WERE -- I RECALL THEY WERE RUNNING THE VENOUS SAMPLES ON THE SIEMENS INSTRUMENTS UNMODIFIED AND THE CELLDYNE RUBY FOR CBC'S.
ADAM ROSENDORFF: CORRECT.
MR. WADE: THEY WERE PERFORMING TESTS OUT AT THE SAFEWAY LABORATORY, OR AT THE SAFEWAY HEADQUARTERS -- I'M SORRY -- AT THE THERANOS LABORATORY; RIGHT?
ADAM ROSENDORFF: THESE TESTS WERE FOR SAFEWAY EMPLOYEES AT THEIR HEADQUARTERS IN PLEASANTON.
MR. WADE: AND AT WHAT POINT DID YOU GET INVOLVED IN OVERSEEING THOSE, NOT IN A CLIA CAPACITY, BUT JUST AS AN EMPLOYEE? DID YOU HAVE ANY ROLE IN OVERSEEING THE OPERATION OF THOSE TESTS?
MR. WADE: AND WHEN YOU -- WERE THERE ANY STEPS THAT YOU UNDERTOOK IN BETWEEN THE PERIOD WHEN YOU WEREN'T THE CLINICAL LAB DIRECTOR TO FAMILIARIZE YOURSELF WITH THE STATUS OF THE CLIA LAB?
ADAM ROSENDORFF: YES. I WOULD HAVE FREQUENT DISCUSSIONS WITH LABORATORY STAFF. I SPENT A LOT OF TIME IN THE ACTUAL LABORATORY AND FAMILIARIZED MYSELF WITH THE INSTRUMENTATION, WITH THE LABORATORY INFORMATION SYSTEMS.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES. IT WAS CALLED LABDAQ.
ADAM ROSENDORFF: I BELIEVE SO.
MR. WADE: AND I'LL COME BACK IN A SECOND AND I'LL ASK YOU A FEW QUESTIONS NEXT ABOUT THE NEXT VERSION OF THE LIS.
ADAM ROSENDORFF: UH-HUH.
ADAM ROSENDORFF: NO, HE WAS NOT.
ADAM ROSENDORFF: ABOUT ONCE A MONTH.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND DID YOU THINK THAT IT WAS -- WAS IT YOUR UNDERSTANDING THAT IT WAS APPROPRIATE UNDER CLIA TO HAVE A PART-TIME LAB DIRECTOR?
ADAM ROSENDORFF: YES, IT IS PERMITTED UNDER CLIA.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT. YOU'RE PERMITTED TO DIRECT FIVE LABS UNDER CLIA, I BELIEVE.
ADAM ROSENDORFF: CORRECT, CORRECT.
MR. WADE: SO AS A LAB DIRECTOR, YOU HAVE THE ABILITY TO SPLIT YOUR TIME BETWEEN FIVE DIFFERENT LABS?
ADAM ROSENDORFF: YES, IF YOU -- THAT'S REALLY AN INTERNAL CHOICE. IF YOU BELIEVE THAT YOU CAN FULFILL THOSE DUTIES RESPONSIBLY, THEN YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. AND DID YOU THINK, GIVEN THE SMALL VOLUME OF TESTS AND THE FACT THAT THEY WERE ON THESE BIG MACHINES, DID YOU THINK THAT MR. HIRAKI WAS DEDICATING ENOUGH TIME IN THAT PERIOD?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT, CORRECT.
ADAM ROSENDORFF: THREE.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. BUT YOU THINK THERE'S A REGULATION THAT ALLOWS YOU TO DO UP TO FIVE; IS THAT RIGHT?
ADAM ROSENDORFF: YEAH. I DON'T KNOW IF THAT'S A BUSINESS AND PROFESSIONS CODE THAT IS SPECIFIC TO CALIFORNIA OR WHETHER THAT'S A CLIA REG. THOSE ARE THE RULES. I DON'T KNOW WHAT THEY FALL UNDER, YEAH.
MR. WADE: AND IS THE ISSUE THERE, THERE'S SOME JUDGMENT THAT IF YOU GO OVER FIVE, THAT'S PROBABLY TOO MANY; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: NO. ONCE YOU'RE THE LAB DIRECTOR OF RECORD, YOU DON'T SIGN SOP'S. YOU KNOW, THE TESTS WERE BEING RUN ACCORDING TO THE PACKAGE INSERTS, THE SIEMENS PACKAGE INSERTS. I WAS FAMILIAR WITH THOSE. I DON'T REALLY RECALL REVIEWING THE SOP'S IN MUCH DETAIL, NO.
MR. WADE: NOW, GIVE US ALL A SENSE OF THE NUMBER OF SOP'S THAT ONE HAS IN A CLIA LAB. DO YOU HAVE AN ESTIMATE ON THE NUMBER OF SOP'S?
ADAM ROSENDORFF: IT'S VERY VARIABLE. IT DEPENDS ON THE NUMBER OF TESTS BEING RUN. IT DEPENDS ON THE REGULATORY ENVIRONMENTS IN THE LABORATORY. SO I CAN'T REALLY GIVE YOU A NUMBER.
MR. WADE: WHEN YOU SAY "REGULATORY ENVIRONMENT," IS THAT WHETHER IT'S A MODERATE COMPLEXITY OR A HIGH COMPLEXITY LABORATORY?
ADAM ROSENDORFF: NO. IT'S JUST THE CULTURE OF THE COMPANY IN TERMS OF HAVING SOP'S AND POLICIES IN PLACE THAT ADDRESS EVERY SINGLE CLIA REQUIREMENT, YEAH.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: SO I JUST WANT TO CLARIFY, NOT -- THERE ARE MANY, MANY, LABORATORIES THAT ARE ACCREDITED BY CAP, THE COLLEGE OF AMERICAN PATHOLOGY. THOSE LABORATORIES WOULD BE TAILORING THEIR SOP'S TO THE CAP CHECKLIST.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THE CLIA PROCESS ACTUALLY, THERE'S A CERTIFICATION PROCESS THAT HAPPENS BEFORE YOU CAN ATTAIN CLIA LICENSING; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND PART OF THAT PROCESS IS THAT YOU HAVE TO GO THROUGH AND SET UP NECESSARY PROCEDURES AND GET NECESSITY PERSONNEL AND EQUIPMENT AND THE LIKE; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND IN THOSE REGULATIONS THAT WE WERE TALKING ABOUT AT 7603, THERE ARE A LOT OF REQUIREMENTS THAT GO TO WHAT IS NECESSARY BEFORE YOU CAN PROPERLY FUNCTION AS A CLIA LABORATORY; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND IT WAS YOUR UNDERSTANDING AT THE TIME THAT YOU CAME INTO THE COMPANY THAT THERANOS HAD ALREADY GONE THROUGH THAT CERTIFICATION PROCESS; RIGHT?
ADAM ROSENDORFF: YES. SO THE FIRST THING THAT HAPPENS IS THAT LABORATORY FIELD SERVICES COMES ON SITE AND THEY DO AN INSPECTION, AND IF THAT GOES WELL, THEY ISSUE A CERTIFICATE OF REGISTRATION, AND THEN AT SOME SUBSEQUENT POINT, THEY COME BACK AND DO ANOTHER INSPECTION AND THEY GIVE YOU A CERTIFICATE OF COMPLIANCE, COC.
ADAM ROSENDORFF: NO. YOU CAN START TESTING AFTER YOU GET YOUR CERTIFICATE OF REGISTRATION.
MR. WADE: SO AFTER THE FIRST CERTIFICATE. BUT THEN THEY'RE GOING TO COME BACK A SHORT TIME LATER AND DO AN INSPECTION; IS THAT RIGHT?
ADAM ROSENDORFF: CORRECT. CORRECT. THAT'S MY UNDERSTANDING, CORRECT.
MR. WADE: OKAY. AND SO THERE ARE TWO VISITS THAT ARE NECESSARY BEFORE YOU ARE KIND OF FULLY CERTIFIED UNDER CLIA?
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. AND IT WAS YOUR UNDERSTANDING AT THE TIME THAT YOU CAME IN THAT THERANOS HAD ALREADY GONE THROUGH THAT PROCESS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I ACTUALLY -- SO I WANT TO CLARIFY. THERANOS WAS RUNNING AND REPORTING PATIENT SAMPLES, I BELIEVE THEY HAD AT LEAST THEIR CERTIFICATE OF REGISTRATION. I DO NOT RECALL IF THEY HAD THE OTHER CERTIFICATE OF COMPLIANCE, YEAH.
MR. WADE: OKAY. WELL, I TAKE IT AT SOME POINT BEFORE YOU BECAME THE LAB DIRECTOR, YOU LEARNED OR ENSURED THAT IT WAS A PROPERLY CERTIFIED LAB.
ADAM ROSENDORFF: YES, YES, OF COURSE.
MR. WADE: AND YOU FILED THE NECESSARY PAPERWORK TO PUT YOURSELF ON THE LAB AS THE LAB DIRECTOR; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND DO YOU RECALL THE DATE ON WHICH YOU BECAME THE, YOU BECAME THE LABORATORY DIRECTOR OF RECORD?
ADAM ROSENDORFF: NO, I DO NOT.
ADAM ROSENDORFF: SUMMER MAYBE. I JUST -- I CAN'T SPEAK TO THAT UNDER OATH. I DON'T HAVE A RECOLLECTION OF IT.
MR. WADE: OKAY. I TAKE IT YOU DON'T RECALL WHEN YOU GOT YOUR NECESSARY LICENSING FROM CALIFORNIA?
ADAM ROSENDORFF: NO, I DO NOT RECALL. NO.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: THERE ARE MULTIPLE CATEGORIES. THERE'S A MODERATE COMPLEXITY, A HIGH COMPLEXITY, THERE'S SOMETHING ELSE CALLED PROVIDER -- PPM, IT'S A MICROSCOPY CERTIFICATION. THERE ARE OTHER LABS DOING CLIA WAVE TESTS. SO THERE ARE A NUMBER OF CATEGORIES.
ADAM ROSENDORFF: RIGHT. SO IF YOU DO EVEN ONE LABORATORY DEVELOPED TEST, YOU'RE IMMEDIATELY CONSIDERED HIGH COMPLEXITY.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THERE ARE SOME PEOPLE WHO COULD BE -- WHO WOULD BE QUALIFIED TO BE MODERATE COMPLEXITY LAB DIRECTORS WHO COULD NEVER BECOME A HIGH COMPLEXITY LAB DIRECTOR; RIGHT?
ADAM ROSENDORFF: THAT'S RIGHT.
MR. WADE: UNLESS THEY WENT BACK TO MEDICAL SCHOOL OR SOMETHING OR GOT A PH.D. IN THE NECESSARY LICENSING?
ADAM ROSENDORFF: YES. THE REQUIREMENTS ARE MORE STRINGENT FOR EDUCATION AND EXPERIENCE IN A HIGH COMPLEXITY LAB VERSUS A MODERATE COMPLEXITY.
ADAM ROSENDORFF: THOSE ARE DETERMINED BY THE LABORATORY FOR THE MOST PART, YEAH.
MR. WADE: WELL, YOU WERE -- YOU ENDED UP BEING THE LAB DIRECTOR OF THIS HIGH COMPLEXITY LAB; RIGHT?
ADAM ROSENDORFF: YES, I WAS.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. SO YOU WERE COMFORTABLE WITH THE LEVEL OF PROCEDURES AND THINGS THAT WERE IN PLACE WHEN YOU PUT YOUR NAME ON TO THE CERTIFICATE?
ADAM ROSENDORFF: AT THE TIME, YES.
MR. WADE: YEAH. WERE THERE OTHER POLICIES THAT YOU PUT IN PLACE IMMEDIATELY OR BEFORE YOU TOOK OVER?
ADAM ROSENDORFF: SO I LISTED A NUMBER OF POLICIES AND PROCEDURES IN THE EMAIL TO ELIZABETH SHORTLY BEFORE THE LAUNCH. THAT'S WHAT I WORKED ON. THAT'S WHAT I RECALL.
ADAM ROSENDORFF: YEAH.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YEAH. I WAS FURIOUSLY WORKING ON DOCUMENTATION BEFORE THE LAUNCH, YEAH.
MR. WADE: IN FACT, IF WE CAN GO BACK TO -- DO YOU RECALL IN THAT EMAIL FROM MR. BALWANI IN ADVANCE OF THE NOVEMBER PUBLIC LAUNCH, DO YOU RECALL THAT DOCUMENT THAT WE WERE LOOKING AT?
ADAM ROSENDORFF: I THINK SO, WHERE I SAID HOW EXCITING THAT WE'RE GOING PUBLIC, OR THAT WE'RE EXPANDING TESTING TO A WIDER BASE? IS THAT THE EMAIL?
MR. WADE: YES. IT'S 12464. CAN WE BRING THAT UP? DO YOU SEE AT THE BOTTOM OF THE FIRST PAGE THERE'S AN EMAIL FROM MR. BALWANI TO YOU? DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
COURT CLERK: IS THIS ADMITTED?
COURT CLERK: IT IS.
BY MR. WADE:
ADAM ROSENDORFF: YES.
MR. WADE: AND HERE MR. BALWANI IS SAYING, "THE KEY IS TO HAVE PERFECT DISCIPLINE AND SOP'S IN PLACE TO MAKE SURE WE HAVE A PLAN FOR EVERYTHING AND EVERYONE IN THE CHAIN KNOWS WHAT NEEDS TO BE DONE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND HE'S -- AND HE THEN SAYS, "WE WILL WORK ON THIS FROM NOW THRU THE NEXT 5 DAYS AND I KNOW WE WILL GET THIS DONE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND THEN HE SAYS, "I WOULD LIKE TO ASK AT THIS TIME IF YOU HAVE A REASON TO THINK THAT WE NEED MORE TIME OR TEST OUT SOMETHING THAT WE HAVEN'T THOUGHT ABOUT." DO YOU SEE THAT?
ADAM ROSENDORFF: YES, YES.
MR. WADE: WE WILL BE PICKING UP -- THERE'S MAYBE A TYPO THERE, BUT HE BASICALLY SAYS THAT THEY'RE GOING TO BE PICKING UP SAMPLES EVERY HOUR OR SO DURING NOVEMBER. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU RESPOND. LET'S LOOK AT THAT. AND YOU SAY, "THIS IS VERY EXCITING THAT WE ARE BROADENING OUR TESTING TO A WIDER BASE?" RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: DO YOU RECALL THAT? AS A LAB DIRECTOR, IT PROBABLY WAS MORE EXCITING TO START HAVING MORE VOLUME AND DIFFERENT TESTS; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND IT SAYS, "THERE ARE A FEW ISSUES THAT NEED TO BE ADDRESSED." SO YOU RESPONDED TO HIS INQUIRY; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES. YES.
MR. WADE: AND DO YOU RECALL IN THIS TIME PERIOD THERE WERE ACTUALLY -- THERE WAS KIND OF A CAP PUT IN PLACE ON THE NUMBER OF SAMPLES THAT WOULD BE HANDLED?
ADAM ROSENDORFF: I DO NOT RECALL THAT.
MR. WADE: WELL, DO YOU RECALL IN THIS TIME PERIOD IN NOVEMBER THERE WAS ONLY THE ONE LOCATION; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND WE HAD TALKED ABOUT THE -- YOU WERE ASKED IN THE GRAND JURY ABOUT WHETHER THE -- IT WAS GOING TO BE IMMINENT THAT YOU WERE GOING TO ENTER THE 40 WALGREENS LOCATIONS. DO YOU RECALL THAT?
ADAM ROSENDORFF: YEAH. THAT'S WHAT I WAS TOLD BY MR. BALWANI, THAT IT WAS IMMINENT THAT THEY WERE GOING TO GO INTO ARIZONA AND HAVE A NUMBER OF LOCATIONS THERE. BUT AS OF NOVEMBER, IT WAS JUST THE WALGREENS IN PALO ALTO.
MR. WADE: RIGHT. AND ACTUALLY, IN THE EMAIL DOWN BELOW, IT SAYS, WE WILL BE OPENING OUR FIRST PHOENIX LOCATION NEXT MID-WEEK; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND DO YOU RECALL THAT THERE WAS ACTUALLY ANOTHER ARIZONA STORE THAT WAS ADDED IN NOVEMBER AS WELL? DO YOU RECALL THAT?
ADAM ROSENDORFF: I DON'T RECALL THE ROLLOUT, THE TIMELINE AND THE ROLLOUT IN ARIZONA. NO, I DO NOT.
MR. WADE: AND DO YOU RECALL IT WASN'T UNTIL ACTUALLY OCTOBER OF 2014 THAT THERE WERE 40 STORES ACROSS ARIZONA?
ADAM ROSENDORFF: AGAIN, I DON'T RECALL THE EXACT SCOPE AND TIMELINE OF THE ARIZONA ROLLOUT.
MR. WADE: BUT YOU RECALL FROM THE VOLUME THAT IN THE EARLY PERIOD IN -- OF THE PUBLIC LAUNCH FROM THE -- IN NOVEMBER GOING FORWARD, THAT THE VOLUME WAS NOT OVERWHELMING; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT, CORRECT.
MR. WADE: AND ONE OF THE THINGS THAT YOU WERE FOCUSSED ON WITH DR. PANDORI AND OTHERS WAS WORKING TO GET STRONG PROCEDURES AND POLICIES IN PLACE WHILE THE VOLUME WAS STILL LOW; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THAT GAVE YOU MORE TIME TO DO SOME THINGS LIKE SOME OF THESE STUDIES AND SOME OF THESE OTHER THINGS TO TRY TO GET COMFORTABLE WITH THE PROCEDURES; RIGHT?
ADAM ROSENDORFF: FROM MY PERSPECTIVE, THE VOLUME IS NOT -- DOESN'T REALLY MATTER. YOU HAVE TO HAVE POLICIES AND PROCEDURES IN PLACE BEFORE YOU START PATIENT TESTING.
ADAM ROSENDORFF: IT'S NOT THAT THE VOLUME IS LOW, SO NOW WE HAVE BREATHING ROOM TO DO THIS. THIS HAS TO BE DONE EVEN IF YOU'RE TESTING ONE PATIENT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: BUT IN TERMS OF THE OPERATIONAL ASPECTS OF THE LAB, AND HOW IT FUNCTIONS, AND HOW IT HANDLES THINGS, AND HOW IT IS MANAGED ON A DAY-TO-DAY BASIS, YOU HAVE SOME TIME TO WORK THAT OUT; RIGHT?
ADAM ROSENDORFF: YES. DEFINITELY ON THE OPERATIONAL ISSUES, YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: NOW, THIS MAY BE ROUTINE TO YOU, BUT PLEASE BEAR WITH ME. THESE SOP'S AND POLICIES THAT YOU PUT IN PLACE, A LOT OF THEM ARE ACTUALLY SPECIFICALLY REQUIRED BY THE REGULATIONS; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I GUESS SO. YOU'RE MAKING A JOKE, BUT I GUESS SO.
ADAM ROSENDORFF: YES.
MR. WADE: AND WHAT IS THE PURPOSE? CAN YOU JUST EXPLAIN FOR THE LADIES AND GENTLEMEN OF THE JURY THE PURPOSE OF HAVING SOP'S AND WHY IT'S IMPORTANT TO DOCUMENT THEM?
ADAM ROSENDORFF: RIGHT. SO AN SOP IS A SERIES OF STEPS THAT THE LAB TECHS TAKE DURING TESTING, AND THE GOAL IS TO MAKE SURE THAT ALL OF THE TECHS ARE DOING THE SAME THING, THAT THEY'RE STANDARDIZATION BETWEEN LAB TECHS, THAT THEY'RE EXECUTING THE TESTS IN A WAY THAT COMPLIES WITH HOW. THE TEST IS SUPPOSED TO BE RUN SO THAT ACCURATE TESTS COME OUT. THERE ARE OTHER SOP'S THAT DEAL WITH PROFICIENCY TESTING OR POST-ANALYTIC ASPECTS LIKE PATIENT REPORTING, AND PREANALYTIC LIKE HOW YOU COLLECT THE SAMPLE. AN SOP IS AN OPERATING PROCEDURE THAT SPELLS OUT IN DETAIL HOW THINGS SHOULD BE DONE AND MAKES SURE THAT EVERYBODY IS ON THE SAME PAGE.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND THAT QUALITY ASSURANCE SYSTEM IS SOMETHING THAT THE LAB DIRECTOR IS ULTIMATELY RESPONSIBLE FOR; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: QM MANAGER, CORRECT.
ADAM ROSENDORFF: THAT'S CORRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND HE HAS A WHOLE SET OF POLICIES AND A WHOLE SYSTEM THAT IS DESIGNED TO ASSURE QUALITY CONTROL AND FUNCTIONING WITHIN THE LAB?
ADAM ROSENDORFF: YES.
MR. WADE: RIGHT? AND SO YOU HAVE THAT WHOLE SPACE; RIGHT? AND THEN YOU ALSO HAVE A LOT OF VERY SPECIFIC REQUIREMENTS THAT NEED TO BE DOCUMENTED WITHIN THESE PROCEDURES; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: IT WAS EFFECTIVE ON JUNE 9TH, 2011. I DO NOT KNOW IF THERE WAS A SUPERSEDING DOCUMENT THAT WOULD HAVE REPLACED THIS. I WOULD NEED TO GO INTO THE DOCUMENT CONTROL SYSTEM TO SEE THAT.
MR. WADE: BUT YOU RECOGNIZE THAT THIS IS PART OF THE DOCUMENT FORMAT AND DOCUMENT CONTROL SYSTEM THAT WAS USED TO TRACK DIFFERENT POLICIES WITHIN THE CLIA LAB AT THERANOS; RIGHT?
ADAM ROSENDORFF: THIS IS A -- THIS IS A PROCEDURE, SIR.
ADAM ROSENDORFF: CORRECT, CORRECT.
ADAM ROSENDORFF: PROCEDURE, CORRECT.
MR. WADE: OKAY. PROCEDURE. I STAND CORRECTED, DOCTOR. AND IT'S KEPT IN THE FORMAT AS A CONTROL DOCUMENT THAT WAS NECESSARY WITHIN THE LAB; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9903 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: SIR, THIS IS, I'M GOING TO GUESS, 120 PAGES THAT RELATES TO THE MONITORING OF TEMPERATURES WITHIN THE REFRIGERATOR AND FREEZER AT THE LAB; RIGHT?
ADAM ROSENDORFF: I DON'T KNOW HOW MANY PAGES ARE HERE. THESE PROCEDURES APPEAR TO APPLY TO TEMPERATURE MONITORING, YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I'M SORRY?
ADAM ROSENDORFF: OH, I SEE.
MR. WADE: -- 558. IF YOU JUST FLIP TO THE BACK. I'M JUST FOCUSSED ON THE VERY LAST PAGE, DR. ROSENDORFF?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: THEY'RE NOT ALL PROCEDURES. THERE ARE TEMPERATURE LOGS IN HERE THAT WOULD BE FILLED OUT BY A LABORATORY STAFF.
MR. WADE: I'M GLAD YOU MADE THAT POINT BECAUSE ONE OF THE REQUIREMENTS IN THIS PROCEDURE IS SPECIFIC AND ROUTINE REGULAR MONITORING --
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THE REASON I SHOW THIS IS THAT THIS IS TYPICAL OF MANY OF THE SPECIFIC PROCEDURES WITHIN THE CLIA LAB; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I'M THERE.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9915 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
ADAM ROSENDORFF: YES. I CAN MAKE OUT HIS HANDWRITING AS THE APPROVER, YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: HOW? WHEN? THAT'S A PROCEDURE FOR TEST REPORTING, YES.
MR. WADE: RIGHT. AND ARE THERE SPECIFIC RULES AND REGULATIONS THAT REPORT TO THAT -- RELATE TO THAT?
ADAM ROSENDORFF: YES, ABSOLUTELY.
ADAM ROSENDORFF: ON A ROUTINE BASIS?
ADAM ROSENDORFF: THE CLINICAL LABORATORY SCIENTISTS.
ADAM ROSENDORFF: YEAH, THEY RELEASE THE RESULTS FROM THE LAB INTO THE REPORTING SYSTEM.
MR. WADE: AND WE'VE SEEN WITHIN THE DOCUMENTS THAT YOU HAVE BEEN ASKED QUESTIONS ABOUT CLS EMAIL GROUPS; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THOSE EMAIL GROUPS ARE DESIGNED TO GO TO THE PEOPLE WHO HAVE THE AUTHORITY TO RELEASE THE TESTS; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: IN GENERAL. THERE'S A GOVERNOR, THERE WAS A GOVERNOR'S DECLARATION FOR COVID THAT EXEMPTED WHERE CLS WAS NO LONGER REQUIRED TO RELEASE COVID RESULTS.
ADAM ROSENDORFF: BECAUSE OF THE EMERGENCY. BECAUSE OF THE PANDEMIC, YEAH.
MR. WADE: OKAY. BUT AS A GENERAL MATTER, WITH THE EXCEPTION OF COVID RESULTS, THERE WERE NO -- THERE WAS NO COVID-19 TESTING DONE AT THERANOS; RIGHT?
ADAM ROSENDORFF: NO, NO.
ADAM ROSENDORFF: I DO NOT RECALL.
MR. WADE: OKAY. THE -- IN ANY EVENT, WITH RESPECT TO THIS, I BELIEVE YOUR TESTIMONY IS THAT THE CLS'S ARE AUTHORIZED TO RELEASE REPORTS?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND ARE THERE SOME OTHER MORE SENIOR PEOPLE WHO COULD DO THAT, TOO? LIKE I ASSUME YOU COULD RELEASE A RESULT?
ADAM ROSENDORFF: YES, YES.
MR. WADE: OKAY. IS THERE ANYONE BETWEEN THE CLS AND THE LAB DIRECTOR WHO HAS THE LEGAL AUTHORITY TO RELEASE RESULTS?
ADAM ROSENDORFF: YOU NEED THE CLS, SO I DON'T RECALL EXACTLY. I THINK THE TECHNICAL SUPERVISOR HAS TO BE CLS BUT THE GENERAL SUPERVISOR DOES NOT. I'LL HAVE TO REVIEW THE REGULATIONS, BUT YOU NEED A CLS LICENSE TO RELEASE TEST RESULTS, YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND I THINK WE TALKED ABOUT BEFORE, MS. HOLMES WAS NOT QUALIFIED TO HAVE ANY OF THOSE POSITIONS WHERE YOU COULD RELEASE RESULTS; RIGHT?
ADAM ROSENDORFF: NO, SHE WAS NOT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: NO, NOT TO MY KNOWLEDGE.
ADAM ROSENDORFF: IT WOULD NOT HAVE BEEN APPROPRIATE, NO.
MR. WADE: AND IS IT YOUR BELIEF, SIR, THAT DURING YOUR TIME PERIOD AS LAB DIRECTOR AT THERANOS THAT YOU FOLLOWED THE LEGAL REQUIREMENTS AND POLICIES WITH RESPECT TO TEST REPORTING?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND AT SOME POINT DO YOU RECALL THAT THERE WAS A NEW LIS SYSTEM THAT WAS PUT IN PLACE WITHIN THE THERANOS LAB?
ADAM ROSENDORFF: YES. IT WAS CALLED SUPER MARIO, I BELIEVE.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND, AGAIN, FOR THE BENEFIT OF THE JURY, YOU WERE SHOWN A LOT OF EMAILS RELATING TO TEST RESULTS; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND QUESTIONS WERE ASKED BASED UPON SNIPPETS OF INFORMATION THAT WAS INCLUDED WITHIN THE EMAILS; RIGHT? SOMETIMES DATA? SOMETIMES PATIENT INFORMATION; RIGHT?
ADAM ROSENDORFF: THE QUESTIONS WERE BASED ON THE EMAIL CONTENT, YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND YOU DIDN'T MAINTAIN THE PATIENT RECORDS IN ALL OF THE TESTING DATA WITHIN EMAIL; RIGHT?
ADAM ROSENDORFF: IT'S THE, IT'S THE ISSUES THAT ARE ESCALATED THAT ARE RECORDED IN EMAIL AS BUSINESS RECORDS. ALL OF THE LABORATORY RESULTS AND REPORTS BY LAW NEED TO BE MAINTAINED WITHIN THE LABORATORY INFORMATION SYSTEM, AND YOU'RE REQUIRED TO MAINTAIN THE TEST REPORTS AS WELL.
MR. WADE: RIGHT. AND THAT'S A SPECIAL, THAT'S A SPECIAL DATABASE THAT TRACKS ALL OF THE ASPECTS OF TESTING; RIGHT?
ADAM ROSENDORFF: SO THE LABORATORY INFORMATION SYSTEM RECORDS WHAT HAPPENED WITHIN THE LABORATORY. THERE ARE OTHER SYSTEMS THAT ARE USED TO STORE THE ACTUAL REPORTS AND TO STORE WHAT ARE CALLED ASSESSIONS, WHICH IS THE ACTUAL ORDER FOR THE TEST THAT IS FILLED OUT BY THE ORDERING CLINICIAN. DOES THAT ANSWER YOUR QUESTION?
MR. WADE: SO THE LIS TRACKS A LOT OF SPECIFIC DETAILS ABOUT THE TEST THAT WAS PERFORMED AND THE RESULTS THAT WERE -- THAT RESULTED; RIGHT?
ADAM ROSENDORFF: CORRECT, THE SAMPLE THAT WAS PROCESSED, THE METHOD IT WAS RUN ON, THE TIME THAT IT WAS PROCESSED, THE TIME THAT IT WENT TO EACH PART OF THE ANALYTIC PROCESS, ET CETERA.
MR. WADE: AND THE NEW -- NOT THE OLD LAB DAQ SYSTEM, BUT THE NEW SYSTEM THAT WAS PUT IN PLACE, SUPER MARIO, OR WHATEVER IT WAS CALLED, THAT WOULD TRACK EVEN MORE INFORMATION THAN LAB DAQ, D-A-Q; RIGHT?
ADAM ROSENDORFF: I CAN'T REALLY SPEAK TO THAT. I DESCRIBED WHAT A GOOD LABORATORY INFORMATION SYSTEM SHOULD DO. I'M NOT TESTIFYING AS TO WHAT SUPER MARIO WAS CAPABLE OF.
MR. WADE: OKAY. BUT -- THANK YOU FOR CLARIFYING. YOU DID TESTIFY THAT YOU NEED AN LIS TO BE A CLIA COMPLIANT LAB; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND ISN'T IT THE CASE THAT SOMETIMES WHEN AN ISSUE AROSE, SOMEONE WOULD GO AND PULL INFORMATION FROM THE LIS TO GIVE YOU MORE DATA TO CONSIDER; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES, YES.
ADAM ROSENDORFF: YES.
MR. WADE: BOTH THE TYPE OF MACHINE LIKE WAS IT A BIG MACHINE, AN EDISON, OR SOME OTHER MACHINE; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I CAN'T SPEAK TO -- IT SHOULD. A GOOD LIS WILL RECORD THE SERIAL NUMBER OF THE INSTRUMENT THAT WAS USED FOR THAT SAMPLE.
ADAM ROSENDORFF: YES, THOSE ARE STORED IN LIS, YES.
ADAM ROSENDORFF: TIME OF ARRIVAL IN THE LAB OF THE SAMPLE, TIME THAT THE REPORT WAS RELEASED. THE REFERENCE RANGES, THE ACTUAL RESULTS TYPICALLY THERE'S A COMMENT SECTION IN THE LIS THAT COULD BE FILLED OUT BY THE CLS'S.
MR. WADE: AND IN CONNECTION WITH YOUR MEETINGS AND IN PREPARATION FOR YOUR TESTIMONY OR YOUR MEETINGS WITH THE GOVERNMENT PRIOR IN THE CASE, DID THEY EVER SHOW YOU ANY LIS DATA RELATING TO ONE OF THE INCIDENTS?
ADAM ROSENDORFF: NO, THE LIS WAS RENDERED INACCESSIBLE. THAT'S MY UNDERSTANDING.
ADAM ROSENDORFF: NO. THAT HAPPENED AFTER I LEFT.
MR. WADE: OKAY. SO YOU DON'T HAVE ANY OF THE DETAILED INFORMATION THAT RELATES TO ANY OF THE INCIDENTS THAT YOU'VE TALKED ABOUT; RIGHT?
ADAM ROSENDORFF: NO. I DISAGREE. THERE'S A -- ALL OF THE PERTINENT -- I WOULD ASK FOR ALL OF THE PERTINENT INFORMATION ON A PATIENT QUERY. FOLKS LIKE MAX FOSQUE WHO RAN THE LIS, I WOULD GATHER ALL OF THE INFORMATION TO DO AN INVESTIGATION IN INSTANCES WHERE THERE WAS A PATIENT COMPLAINT OR A DOCTOR COMPLAINT, ET CETERA.
MR. WADE: I DIDN'T MEAN TO SUGGEST OTHERWISE. MY POINT IS ACTUALLY JUST THAT. WHEN SOMETHING WOULD COME UP, YOU WOULD HAVE MAX FOSQUE OR SOMEONE WHO HAD ACCESS TO LIS GATHER ALL -- SCRAPE ALL OF THE DATA OUT OF THERE, GET THE REPORT, HAVE ALL OF THE DETAILS, AND ONLY THEN WOULD YOU BE IN A POSITION TO FULLY ANALYZE THE POSITION; RIGHT?
ADAM ROSENDORFF: YES, I WAS ALSO ABLE TO LOG INTO THE LIS AND CHECK THINGS ON MY OWN.
ADAM ROSENDORFF: YES, I DID.
ADAM ROSENDORFF: I DO NOT KNOW.
MR. WADE: YEAH. WELL, YOU NEVER, YOU NEVER HAD ANY INTERACTION WITH HER THAT LED YOU TO BELIEVE THAT SHE DID; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: AND IT WOULD NOT JUST GIVE YOU INFORMATION ABOUT THAT SPECIFIC PATIENT, BUT IT WOULD GIVE YOU INFORMATION ABOUT OTHER TESTS, RIGHT, OF THE SAME KIND THAT WERE MAYBE RUN IN THE SAME MONTH, FOR EXAMPLE?
ADAM ROSENDORFF: YES. DATABASE QUERIES ARE -- YOU'RE ABLE TO DO DATABASE QUERIES ON THE LIS AND COLLECT INFORMATION IN ANY NUMBER OF WAYS, YEAH.
MR. WADE: SO YOU COULD LOOK AT A SPECIFIC TYPE OF ASSAY, PULL ALL OF THE RESULTS FOR A PARTICULAR MONTH AND SEE IF THEY TOLD YOU ANYTHING; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND YOU COULD PULL OUT THEORETICALLY ALL OF THE EDISON ASSAYS AND LOOK AT THEM IN TOTAL AND SEE IF IT TOLD YOU ANYTHING; RIGHT?
ADAM ROSENDORFF: YEAH, THESE ARE ALL FEATURES OF AN IDEAL LIS.
ADAM ROSENDORFF: JUST TO BE PERFECTLY TRUTHFUL, I DON'T REMEMBER WHAT THE FULL CAPABILITIES WERE OF SUPER MARIO.
ADAM ROSENDORFF: NO. I MEAN, THE INFORMATION WAS AVAILABLE TO ME, WHETHER IT CAME FROM LIS OR OTHER SOURCES.
ADAM ROSENDORFF: YES, I HAVE IT.
MR. WADE: AND DO YOU RECOGNIZE THIS TO BE ONE OF THE POLICIES OR PROCEDURES THAT WAS IMPLEMENTED IN THE THERANOS CLIA LAB?
ADAM ROSENDORFF: THIS IS A QUALITY ASSISTANCE MANUAL THAT WAS EFFECTIVE IN 2011 WRITTEN BY ARNE GELB AND APPROVED BY SPENCER HIRAKI.
MR. WADE: AND BASED ON THE FORMAT, YOU UNDERSTOOD THAT THIS WOULD HAVE BEEN A MANUAL THAT WAS IN PLACE AT THE TIME IN THE THERANOS CLIA LAB?
ADAM ROSENDORFF: I'M SORRY, DURING WHAT TIME PERIOD?
ADAM ROSENDORFF: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9910 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND I BELIEVE YOU TESTIFIED THAT THIS WAS A POLICY THAT WAS PUT IN PLACE IN DR. GELB'S PERIOD; RIGHT?
ADAM ROSENDORFF: SO ONE THING THAT DOESN'T JIBE HERE IS THAT SPENCER HIRAKI IS LISTED AS THE CO-DIRECTOR, AND HE'S ALSO LISTED AS ONE OF THE SIGNATORIES OF THE MANUAL. SO YOU WOULD HAVE TO ASK LFS WHO WAS ON THE LICENSE AT THE TIME. AND IT APPEARS FROM THIS THAT THEY WERE ACTUALLY CO-DIRECTORS. AND IF YOU SEE UNDER SPENCER'S NAME IT SAYS CO-DIRECTOR.
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. AND LET'S LOOK AT 9945. AND DO YOU RECOGNIZE THIS TO BE A QUALITY SYSTEMS MANUAL THAT WAS IN PLACE WHEN YOU WERE THE LABORATORY DIRECTOR AT THERANOS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9945 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
ADAM ROSENDORFF: YES.
MR. WADE: AND DO YOU RECALL WE WERE PREVIOUSLY DISCUSSING HOW OVER TIME YOU WERE WORKING TO CONTINUOUSLY IMPROVE THE QUALITY SYSTEMS OPERATION; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND, IN FACT, UNDER CLIA CONTINUOUS IMPROVEMENT IS SORT OF A CONCEPT THAT IS ENCOURAGED; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THERE IS ACTUALLY A SPECIFIC SET OF PROCEDURES WITHIN THE CLIA REGULATIONS THAT TALK ABOUT HOW YOU DEAL WITH PROBLEMS; RIGHT?
ADAM ROSENDORFF: CAN YOU BE MORE SPECIFIC.
MR. WADE: WELL, THERE ARE PROCEDURES THAT TALK ABOUT THINGS YOU GO THROUGH, STEPS YOU GO THROUGH TO TRY TO PREVENT PROBLEMS. THAT'S LIKE A QUALITY SYSTEMS MANUAL. DO YOU RECALL?
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THERE ARE REQUIREMENTS FOR WHAT YOU SHOULD DO IF A PROBLEM ARISES AND WHAT YOU SHOULD DO AND DOCUMENT AND THE LIKE?
ADAM ROSENDORFF: CORRECT, CORRECT.
MR. WADE: OKAY. AND ONE OF THE CONCEPTS THAT YOU'RE SUPPOSED TO DO UNDER CLIA REGULATIONS IS TO LEARN FROM YOUR MISTAKES AND TRY TO STRENGTHEN THE POLICY AS A RESULT OF THEM; RIGHT?
ADAM ROSENDORFF: CLIA DOES NOT DETAIL A PRESCRIBED HOW OUR LAB SHOULD GO ABOUT IMPROVING ITS QUALITY. IT'S A SET OF REGULATIONS THAT ARE DESIGNED TO ENSURE GOOD LABORATORY PRACTICE AND GOOD PATIENT CARE.
MR. WADE: OKAY. WELL, WE'LL GO INTO THOSE REGULATIONS A BIT MORE TOMORROW, BUT THIS PROCEDURE THAT WAS IN PLACE AT 9945 WAS MADE EFFECTIVE 7-28-2014; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: AND THAT WAS PART OF AN EFFORT BY YOU AND THE TEAM THAT YOU WERE WORKING WITH TO TRY TO STRENGTHEN THE QUALITY SYSTEMS WITHIN THE CLIA LAB?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: A TECHNICAL SUPERVISOR.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND THEN WE SEE HODA ALAMDAR WHO YOU TALKED ABOUT BEFORE. AND THEN WE SEE LINA CASTRO; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YOUR HONOR, MAY I HAVE A FEW MINUTES FOR A RESTROOM BREAK?
JUDGE DAVILA: YES. SHOULD WE --
JUDGE DAVILA: WHY DON'T WE BREAK FOR THE DAY. WE'LL BREAK FOR THE DAY. WE'LL TAKE OUR RECESS NOW, LADIES AND GENTLEMEN. WE'LL START AT 9:00 O'CLOCK. MAY WE GO UNTIL 4:00 TOMORROW? DOES THAT CAUSE INCONVENIENCE FOR OUR JURORS? I SEE NO HANDS. THANK YOU SO MUCH FOR YOUR GENEROSITY. BEFORE WE BREAK, LADIES AND GENTLEMEN, LET ME REMIND YOU AGAIN, PLEASE DO NOT COMMUNICATE WITH ANYONE IN ANY WAY ABOUT THIS CASE, PLEASE AVOID ANY INFORMATION ABOUT THE CASE YOU MIGHT SEE WHILE BROWSING YOUR SOCIAL MEDIA OR ANY INTERNET ACTIVITY. AVOID ANY NEWSPAPER ARTICLES AND TELEVISION ADS ABOUT THIS. I'LL ASK YOU TOMORROW WHETHER OR NOT ANY OF THOSE THINGS HAVE HAPPENED. HAVE A GOOD EVENING, AND WE'LL SEE YOU TOMORROW AT 9:00 O'CLOCK. THANK YOU.
(JURY OUT AT 2:55 P.M.)
JUDGE DAVILA: ALL RIGHT. PLEASE BE SEATED. THANK YOU. THE RECORD SHOULD REFLECT THAT OUR JURY HAS LEFT FOR THE DAY. I THINK THE WITNESS IS GONE. YES. ANYTHING FURTHER BEFORE WE BREAK?
MR. BOSTIC: YOUR HONOR, I BELIEVE THE PARTIES HAD SPOKEN WITH THE COURT ABOUT WHETHER NOW MIGHT BE A GOOD TIME TO DISCUSS THE ADDITIONAL POST-THERANOS TOPICS RELATED TO DR. ROSENDORFF.
JUDGE DAVILA: ARE WE READY TO TALK ABOUT THAT NOW, MR. WADE?
MR. WADE: WE MAY BE. THERE MAY BE SOME ISSUES THAT I COULD RAISE. FRANKLY, I WOULD PREFER TO DO IT AT SIDE-BAR AND CONSIDER WHETHER WE COULD KEEP A PORTION OF THAT SEALED. I KNOW THAT --
JUDGE DAVILA: PARDON ME FOR INTERRUPTING YOU. WHY DON'T WE DO THIS. WE JUST FINISHED THIS WITNESS'S TESTIMONY. I WAS WONDERING WHETHER WE WERE GOING TO MOVE INTO ANY OF THIS. WHAT I WOULD LIKE YOU TO DO -- AND PARDON ME, I'M NOT COMMENTING ON YOUR ANSWER AT ALL, BUT IT MIGHT BENEFIT YOU TO TALK WITH YOUR TEAM, MR. WADE, ABOUT WHAT YOU'RE GOING TO DO AND HOW YOU'RE GOING TO DO THAT AND, YOU KNOW, IF YOU FEEL THE OPPORTUNITY TO COMMUNICATE WITH THE GOVERNMENT TO ENHANCE OUR CONVERSATION TOMORROW MORNING, THAT WOULD BE HELPFUL.
MR. WADE: I'M HAPPY TO DO THAT, YOUR HONOR. I THINK MY SENSITIVITY IS OBVIOUSLY THE WITNESS IS ON CROSS-EXAMINATION AND THE WITNESS HAS COUNSEL. YOU MAY HAVE NOTICED THERE WERE A FEW MEMBERS OF THE MEDIA PRESENT AND HIS COUNSEL IS PRESENT AND HAS THE RIGHT TO OBSERVE THIS. I'M NOT INCLINED TO PREVIEW ALL CROSS-EXAMINATION APPROACHES IN ADVANCE. IF THERE'S A DESIRE TO RAISE SPECIFIC ISSUES, I'M HAPPY TO SHARE WITH THE GOVERNMENT AT THIS POINT BECAUSE I HAVE THE WITNESS ON CROSS. IF THERE'S A DESIRE TO GET INTO SPECIFIC DETAIL IN ADVANCE SO THE GOVERNMENT CAN RAISE THEIR ISSUES, WHICH I HAVE NO OBJECTION TO, I WOULD JUST ASK THAT WE DO IT AT SIDE-BAR, WE HAVE THAT SEALED UNTIL HE'S DONE TESTIFYING, AND THEN IT CAN BE UNSEALED.
JUDGE DAVILA: OH, LET'S SEE. THE SIDE-BAR CONVERSATION YOU'RE SPEAKING TO?
JUDGE DAVILA: OKAY. AND THIS IS -- I THINK WHAT WE'RE TALKING ABOUT HERE WE DISCUSSED PREVIOUSLY IS ANY POST-THERANOS EMPLOYMENT WITH THIS WITNESS. MR. BOSTIC.
MR. BOSTIC: THAT'S CORRECT, YOUR HONOR. I BELIEVE THERE ARE TWO CATEGORIES OF INFORMATION WE ARE TALKING ABOUT THAT GOES UNDER THAT UMBRELLA TOPIC. ONE IN PARTICULAR RELATES TO DOCUMENT PRODUCTION BY THE GOVERNMENT SUBJECT TO A STIPULATED PROTECTIVE ORDER THAT THE COURT SIGNED.
JUDGE DAVILA: OKAY.
MR. WADE: AND WE HAVE GIVEN NOTICE THAT WE MAY USE THOSE MATERIALS, IN PARTICULAR I -- THERE'S A, THERE'S A --
JUDGE DAVILA: LET ME. PARDON ME, AGAIN. I APOLOGIZE, MR. WADE. IF YOU HAVE, TO THE EXTENT THAT YOU FEEL COMFORT, IF YOU CAN IDENTIFY WHAT THOSE DOCUMENTS ARE AND THEN EMAIL THEM TO MS. KRATZMANN JUST TO SHARE WITH THEM IN ADVANCE SO I HAVE SOME TIME TO LOOK AT IT.
JUDGE DAVILA: WOULD THAT BE HELPFUL?
MR. WADE: WE WOULD BE HAPPY TO DO THAT. AGAIN, WE'RE NOT -- WE'RE TRYING TO BE AS TRANSPARENT AS WE CAN BE WITHOUT REVEALING THE INFORMATION. ONE OTHER NOTE, YOUR HONOR, JUST ON THIS WITNESS. I THINK THE WITNESS EXPLAINED THAT HE HAS A CONFLICT AT 2:00 O'CLOCK TOMORROW.
JUDGE DAVILA: RIGHT.
MR. WADE: I THINK THERE WAS SOME UNCERTAINTY. I WILL NOT BE DONE AT 2:00 O'CLOCK TOMORROW. I THINK WE WILL SEE OCTOBER BEFORE WE SEE ANOTHER WITNESS UNLESS WE TAKE ONE OUT OF ORDER. SO I WANTED TO JUST RAISE THAT AND GET THE COURT'S --
JUDGE DAVILA: NO. THANK YOU. I WANTED TO ASK YOU ABOUT HOW MUCH TIME, WHETHER OR NOT -- I THINK THE PHRASE FRIDAY WAS CLOSER TO THE END THAN THE BEGINNING I THINK.
(LAUGHTER.)
JUDGE DAVILA: TOMORROW.
MR. WADE: -- TOMORROW. AND CERTAINLY IF IT'S UNTIL 2:00 ALL DAY TOMORROW, AND I'LL HAVE A BETTER SENSE AFTER THAT.
JUDGE DAVILA: OKAY.
JUDGE DAVILA: SURE. WELL, WHAT I'VE ASKED THE JURY TO DO IS TO HAVE A 4:00 O'CLOCK DAY TOMORROW. AND IT SOUNDS LIKE WE WOULD BREAK THIS WITNESS'S TESTIMONY AND TRY TO FILL THE GAP WITH ANOTHER WITNESS, MR. BOSTIC? WOULD THAT BE POSSIBLE?
MR. BOSTIC: YOUR HONOR, I'D LIKE TO HAVE A FIRM ANSWER ON THAT NOW. UNFORTUNATELY, WE STILL NEED TO CHECK WITH OUR OTHER WITNESSES WHO ARE NEXT IN THE LINEUP. I ALSO UNDERSTAND THAT THE DEFENSE IS WILLING TO AGREE TO CERTAIN WITNESSES COMING NEXT IN ORDER BUT NOT OTHERS, SO I THINK THERE MAY BE SOME ADDITIONAL CONVERSATION TO HAVE WITH DEFENSE COUNSEL ON THAT.
MR. WADE: IF I CAN JUST RAISE THAT ISSUE AND MAYBE MAKE A SUGGESTION. WE'LL MEET AND CONFER AND SEE IF WE CAN WORK THIS OUT. WE WANT TO BE AS FLEXIBLE AS WE CAN FOR THE WITNESSES. I BELIEVE THE NEXT WITNESS IS THE NEXT LAB DIRECTOR, AND WE WOULD NOT WANT TO START THE EXAMINATION OF THAT LAB DIRECTOR UNTIL WE COMPLETED THIS BECAUSE SOME OF WHAT WE LEARN HERE MAY RELATE TO THAT EXAMINATION. THAT IS SORT OF THE CONCERN THAT WE WOULD HAVE AT THAT LEVEL. BUT THE MORE PRACTICAL CONCERN IS, YOUR HONOR, I'M EXAMINING BOTH WITNESSES. IT WOULD BE VERY DIFFICULT FOR ME TO DO THIS EXAMINATION, AND THEN BE PREPARED TO TAKE A SEPARATE WITNESS IN PART BECAUSE I DON'T THINK WE WOULD FINISH.
JUDGE DAVILA: OH, MR. WADE. YOU WOEFULLY UNDERESTIMATE YOUR SKILLS, MR. WADE.
MR. WADE: WHAT I WAS GOING TO SUGGEST, I KNOW THE GOVERNMENT HAS SOME OTHER WITNESSES THAT THEY HAVE IDENTIFIED. IF THERE IS CONCERN ABOUT WHETHER THEY CAN GET THAT WITNESS UP AND DOWN, WE CAN MAYBE EVEN, YOU KNOW, BREAK -- DR. ROSENDORFF, I UNDERSTAND, LIVES IN SAN FRANCISCO. MAYBE WE CAN STOP AT THE LUNCH BREAK WITH DR. ROSENDORFF AND THEN MAKE SURE WE CAN GET, YOU KNOW, A FULL WITNESS IN, BUT I JUST AM WANTING TO BE --
JUDGE DAVILA: WELL, HE SAID HE NEEDS TO FINISH AT 2:00. I DON'T KNOW IF THAT MEANS FINISH HERE OR HE HAS AN APPOINTMENT AT 2:00. I THINK HE SAID FINISH AT 2:00. HE HAS AN OBLIGATION. MAYBE HE'S FACTORED IN HIS TRAVEL TIMING ON THAT. BUT I'M GOING TO HONOR HIS REQUEST, AND WE'LL BREAK WITH HIM TOMORROW AT 2:00. I HOPE WE CAN CAPTURE THE BALANCE OF THOSE TWO HOURS WITH ANOTHER WITNESS OF SOME SORT. I UNDERSTAND THE RETICENCE TO GO WITH ANOTHER DIRECTOR. YOU'LL HAVE THAT PERSON ON CROSS AS WELL, AND I UNDERSTAND THE ISSUE WITH THAT FROM BOTH PERSPECTIVES. IT'S BETTER TO HAVE A CHRONOLOGY OF DIRECTORS IF THAT'S HOW IT'S GOING. I DON'T KNOW. BUT WHY DON'T YOU SEE WHAT YOU CAN DO WITH THE WITNESS. I DON'T KNOW IF THE GOVERNMENT HAS ANOTHER WITNESS THAT WE CAN FIT INTO THAT -- IT'S A TWO HOUR ESTIMATE. BUT, OF COURSE, THEN YOU HAVE TO FACTOR IN CROSS-EXAMINATION, ET CETERA. FRIDAY WE'RE ONLY GOING TO GO UNTIL 2:00 AT THE LATEST, I DON'T KNOW, MAYBE 1:00, SOMETHING LIKE THAT. SO PLEASE CONSIDER THAT ALSO.
MR. WADE: AND THERE ARE -- THE GOVERNMENT IS, AS WE ALL HAVE DISCUSSED WITH THE COURT, DISCLOSED WITNESSES WHO MAY COME UP THIS WEEK. IF THEY WANT TO RUN POTENTIAL WITNESSES BY US AND IN TERMS OF, YOU KNOW, AN ESTIMATED LENGTH OF CROSS, WE'RE HAPPY TO MEET AND CONFER AND SEE IF WE CAN FIND ONE WE CAN FIT IN THERE.
JUDGE DAVILA: GREAT. I APPRECIATE YOUR EFFORTS ON THAT. I'M NOT ASKING YOU TO REVEAL WHAT YOUR CROSS-EXAMINATION IS, MR. WADE.
MR. BOSTIC: YES, YOUR HONOR. THE PARTIES ARE HAPPY TO MEET AND CONFER ON THAT. OF COURSE, OUR PRIORITIES ARE AVOIDING CONFUSION FOR THE JURY, NOT INCONVENIENCING THE COURT, AND MINIMIZING THE INCONVENIENCE ON WITNESSES, BUT WE WILL LOOK INTO WHAT WE CAN DO TO FILL THAT SLOT TOMORROW.
JUDGE DAVILA: THANK YOU. THIS JURY IS EXPERIENCED WITH TAKING WITNESSES OUT OF ORDER. I THINK THEY'RE BECOMING MORE ACCLIMATED TO THE COURT PROCESS AND IT'S A SMART JURY SO.
MR. BOSTIC: YOUR HONOR, IF I COULD JUST GO BACK TO THE ISSUE OF DISCLOSURE. I JUST WANTED TO NOTE FOR THE COURT, THE PROTECTIVE ORDER COVERING THE DOCUMENT PRODUCTION RELATED TO THE UNRELATED INVESTIGATION OF THE COMPANY WHERE DR. ROSENDORFF ALSO WORKED.
JUDGE DAVILA: RIGHT.
MR. BOSTIC: THAT PROTECTIVE ORDER CONTAINS A PROVISION THAT REQUIRES EITHER PARTY BEFORE USING IT IN OPEN COURT TO PROVIDE THE OTHER PARTY WITH NOTICE OF THE PARTICULAR DOCUMENTS THAT ARE GOING TO BE USED AND TIME FOR THAT FIRST PARTY TO OBJECT. THE ONLY NOTICE THAT WE HAVE RECEIVED THAT I'M AWARE OF FROM THE DEFENSE GIVES US NOTICE OF AN ENTIRE 12,000 PAGE RANGE OF DOCUMENTS THAT THEY MIGHT GO INTO. MY POSITION IS THAT THAT'S NOT IN THE SPIRIT OR THE LETTER OF THE PROTECTIVE ORDER. I'M NOT SURE IF I MISSED SOMETHING ADDITIONALLY FROM THEM WHILE WE'VE BEEN IN THE AFTERNOON SESSION, BUT I WANTED TO RAISE THAT FOR THE COURT IN CASE THAT MIGHT BE A GATING ITEM TO US HAVING A FULL CONVERSATION ABOUT THAT TOPIC.
MR. WADE: I DID NEED THE NIGHT TO REVIEW THE 12,000 DOCUMENTS, YOUR HONOR, BUT I BELIEVE THERE ARE A COUPLE OF DOCUMENTS THAT WE HAVE INCLUDED WITHIN -- THE COURT'S INDULGENCE.
JUDGE DAVILA: CONTAINED ON THAT POST-IT.
MR. WADE: MS. TREFZ HAS PROVIDED ME THE EVER USEFUL GOLDEN TICKET. I BELIEVE THEY'RE WITHIN THESE, THESE VOLUMES. I'M SURPRISED THE GOVERNMENT HASN'T REVIEWED THEM ALREADY. BUT THE -- I WILL GIVE THAT LIST THAT IDENTIFIES SOME OF THEM, AND THERE MAY BE ONE OR TWO OTHERS. AND IF WE IDENTIFIED THEM, AS SOON AS WE IDENTIFY THE POTENTIAL USE, WE WILL RAISE IT WITH THE GOVERNMENT. I THINK THE -- I FORGET EXACTLY WHAT THE MATERIALS ARE, BUT I DON'T THINK IT WILL BE MUCH OF A SURPRISE TO THE GOVERNMENT, AND WE'RE HAPPY TO MEET AND CONFER WITH THEM ON --
JUDGE DAVILA: WELL, THAT WOULD BE GREAT. I APPRECIATE YOUR EFFORTS TO -- IT WOULD MAKE IT A -- MORE EFFICIENT FOR US TO ENGAGE OUR JURY AND GET THE EVIDENCE IN AS NEEDED IF WE CAN. I KNOW YOU MIGHT HAVE SOME DISCUSSIONS ABOUT CERTAIN TOPICS, AND I'M EAGER TO TALK WITH YOU ABOUT THAT. BUT TO THE EXTENT THAT YOU CAN MEET AND CONFER AND IDENTIFY THOSE DOCUMENTS, I'M HAPPY TO HEAR IT'S NOT 12,000 PAGES, THEY FIT ON A POST-IT, A SMALL POST-IT, WHICH IS REFRESHING, SO WE WILL SEE WHAT WE CAN COME UP WITH.
MR. WADE: WE WILL DO THAT, YOUR HONOR. OBVIOUSLY WE HAVE A LITTLE MORE FREEDOM TO HAVE THOSE DISCUSSIONS NOW THAT WE HAVE THE WITNESS ON CROSS.
JUDGE DAVILA: OKAY. THANKS. HAVE A GOOD EVENING. WE'LL SEE YOU TOMORROW.
COURT CLERK: COURT IS ADJOURNED.
(COURT ADJOURNED AT 3:06 P.M.)