Adam Rosendorff — Recross (Recall, Continued)
712 linesRECROSS-EXAMINATION BY MR. WADE:
ADAM ROSENDORFF: HELLO.
MR. WADE: I'D LIKE TO START BY BRINGING UP EXHIBIT 5417, WHICH IS IN EVIDENCE AND THE GOVERNMENT ASKED YOU QUESTIONS ABOUT IT. WE'LL PUT IT UP ON THE SCREEN IF IT'S EASIER FOR YOU, DOCTOR.
ADAM ROSENDORFF: ALL RIGHT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I HAVE IT IN FRONT OF ME.
MR. WADE: OKAY. IT'S A -- AND IF YOU'D LOOK AT THE -- IF WE CAN BLOW UP THE BOTTOM EMAIL, YOU WERE ASKED SOME QUESTIONS ABOUT THIS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THE QUESTIONS THAT YOU WERE ASKED RELATED TO THE FACT THAT MR. BALWANI STATED THAT HE WAS RUNNING THE CLIA LAB NOW, SO HE WAS ASKING TO BE KEPT IN THE LOOP; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND I BELIEVE YOU TESTIFIED THAT HE MENTIONED SOMETHING ABOUT THIS, BUT YOU HAD NO RESPONSE; RIGHT?
ADAM ROSENDORFF: CORRECT.
JUDGE DAVILA: YES.
MR. WADE: DO YOU RECOGNIZE THIS TO BE AN EMAIL BETWEEN YOU AND MR. BALWANI IN JUNE OF 2014 REGARDING CLIA LAB OPS?
ADAM ROSENDORFF: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 13950 WAS ADMITTED IN EVIDENCE.)
MR. WADE: LET'S START AT THE BOTTOM. NOW, YOU PREVIOUSLY TESTIFIED THAT DR. PANDORI LEFT THE LAB AROUND THIS TIME; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND IN RESPONSE TO THAT, FROM AN OPERATIONAL STANDPOINT, MR. BALWANI STEPPED IN TO GIVE ASSISTANCE; CORRECT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: HE DIDN'T JUST WALK INTO THE LAB AND TAKE CONTROL OF IT WITHOUT DISCUSSION WITH YOU, DID HE?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. INSTEAD HE SENT YOU AN EMAIL AND HE SUGGESTED THAT SINCE YOU'RE OUT FOR THE NEXT FEW DAYS, THIS IS NEEDED NO MATTER WHAT. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DON'T RECALL.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND IF DR. PANDORI WASN'T THERE AND YOU WEREN'T THERE, HE WANTED TO MAKE SURE THERE WAS SOMEONE THERE TO HELP KEEP THINGS MOVING; RIGHT?
ADAM ROSENDORFF: MY UNDERSTANDING IS THAT MR. BALWANI WANTED THIS TO BE A PERMANENT ARRANGEMENT.
MR. WADE: OKAY. WELL, SO HE'S SAYING, BECAUSE -- NOW, WHEN DR. PANDORI WAS THERE, YOU TESTIFIED THAT HE HAD SOME SPECIALTIES?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: WE BOTH WERE.
MR. WADE: OKAY. BUT IN THE LAB OPERATIONS, YOU DON'T NECESSARILY HAVE TO BE A LAB DIRECTOR IF YOU'RE SUPERVISED BY A LAB DIRECTOR; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. AND SO DR. PANDORI WAS VERY INVOLVED IN TRYING TO IMPLEMENT SOME OF THE PRACTICES AND PROCEDURES WITHIN THE LAB; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND SO WHEN HE LEFT, MR. BALWANI GIVES YOU NOTICE THAT HE WANTS TO STEP IN ON THE OPS ISSUES. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. LIKE SCHEDULING, DEVICES, ORDERING INVENTORY, DEPARTMENTALIZING PEOPLE, TEAM STRUCTURES, ET CETERA. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND HE SAYS HE'LL FINALIZE AND PUT THIS IN PLACE THIS WEEK. YOU SEE THAT, OF COURSE?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND HE'LL KEEP YOU IN THE LOOP IN EVERY SINGLE RELEVANT EMAIL OF COURSE, BUT BASICALLY WE NEED TO GET THE LAB IN ORDER AS WE SCALE. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: WELL, HE WAS -- HE WAS DOING FAR MORE THAN THAT.
MR. WADE: WELL, HE'S TELLING YOU HERE THAT HE'S GOING TO GET INVOLVED IN THE LAB FROM AN OPERATIONAL STANDPOINT?
ADAM ROSENDORFF: THAT'S WHAT HE'S SAYING, YEAH.
MR. WADE: AND HE ACTUALLY SAYS, I'M UNIQUELY GIFTED AT ORGANIZATIONAL STRUCTURES AND OPS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: HE FELT, BASED ON HIS BUSINESS EXPERIENCE, HIS EXTENSIVE PRIOR BUSINESS EXPERIENCE, THAT HE HAD TALENTS IN THE OPERATIONAL ISSUES; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I'M READING IT.
ADAM ROSENDORFF: I JUST ACKNOWLEDGED HIS EMAIL.
ADAM ROSENDORFF: I DIDN'T SAY GO AHEAD AND, YOU KNOW, TAKE CONTROL OF THE CLIA LAB. I JUST ACKNOWLEDGED HIS EMAIL. THAT'S IT.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND SO YOU KNEW HE WAS COMING IN AND YOU SAID THANKS; RIGHT? THAT'S WHAT THE EMAIL SAYS? THOSE ARE YOUR WORDS?
ADAM ROSENDORFF: I'M THANKING HIM FOR HIS EMAIL.
MR. WADE: OKAY. AND YOU THEN TALK ABOUT ANOTHER PROPOSAL THAT YOU HAVE SINCE MARK PANDORI IS GONE; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: RIGHT? SO THIS WAS -- I BELIEVE YOU, IN YOUR DIRECT -- IN YOUR REDIRECT TESTIMONY, YOU ACTUALLY USED THE WORDS UNIQUELY GIFTED AT ORGANIZATIONAL STRUCTURES OR SOMETHING TO THAT EFFECT; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND JUNE OF 2014, RIGHT IN THIS PERIOD IS THE PERIOD WHEN YOU WERE ALSO DEALING WITH SOME OF THOSE HCG ISSUES AND OTHER THINGS; RIGHT?
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: I THINK SO.
MR. WADE: OKAY. AND SO YOU WERE ASKED A LOT OF QUESTIONS ABOUT THE FACT THAT MR. BALWANI WAS ON EMAILS DURING THIS PERIOD, BUT HE WAS TELLING YOU THAT HE WAS GOING TO BE ON THE EMAILS AND WORK TO INCLUDE YOU BECAUSE HE'S GOING TO TRY AND ADDRESS OPERATIONAL ISSUES; RIGHT? HE'S TELLING YOU THAT?
ADAM ROSENDORFF: IS THERE A QUESTION HERE, SIR?
ADAM ROSENDORFF: HE'S SAYING THAT HE'S GOING TO BE INVOLVED IN OPERATIONAL ISSUES, YES.
MR. WADE: HE'S GIVING YOU NOTICE OF THAT AND HE'S SAYING, "I WILL KEEP YOU IN THE LOOP IN EVERY SINGLE RELEVANT EMAIL OF COURSE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND YOU THANKED HIM FOR IT. AND JUST SO WE'RE CLEAR, SIR, YOU TESTIFIED THAT THERE WERE SEVERAL LABS THAT YOU WORKED IN WHERE YOU WERE A PART-TIME LAB DIRECTOR; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: AT THERANOS?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND WHEN THAT HAPPENS, THERE ARE OTHER PEOPLE WHO TAKE ON RESPONSIBILITIES TO IMPLEMENT THINGS IN, IN AID OF YOUR DIRECTORSHIP?
ADAM ROSENDORFF: YES, THEY'RE ON THE ROSTER.
ADAM ROSENDORFF: SUNNY WASN'T ON THE ROSTER.
MR. WADE: WELL, WE'LL DEAL WITH THAT SEPARATELY. IN FACT, HE WAS ON THE ROSTER OF THE CLIA LAB, WAS HE NOT?
ADAM ROSENDORFF: I DON'T BELIEVE. THAT'S NEWS TO ME.
ADAM ROSENDORFF: IN WHAT CAPACITY, SIR?
MR. WADE: ISN'T IT TRUE THAT MR. BALWANI WAS LISTED IN THE CLIA FORM ON THE ROSTER FOR THE CLIA LAB?
ADAM ROSENDORFF: I DON'T BELIEVE HE WAS, NO.
ADAM ROSENDORFF: HE WOULDN'T HAVE QUALIFIED FOR ANY POSITION.
ADAM ROSENDORFF: OKAY.
MR. WADE: THE GOVERNMENT SHOWED YOU EXHIBIT 1113. LET'S PULL THAT UP. AND THIS APPEARS, I BELIEVE YOU SAID, TO BE A PRESS RELEASE; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THE GOVERNMENT SHOWED YOU THE FIRST AND THIRD PARAGRAPHS. LET'S LOOK AT THE MIDDLE PARAGRAPH. OKAY. THIS SAYS THAT THERANOS AND WALGREENS ARE TAKING THE FIRST STEP IN MAKING THIS SERVICE AVAILABLE TO CONSUMERS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: IT DOESN'T SAY ON THAT DAY, DOES IT? IT DOESN'T SAY IT'S GOING TO HAPPEN ON SEPTEMBER 9TH?
ADAM ROSENDORFF: YES, CORRECT.
MR. WADE: RIGHT. AND, IN FACT, WHEN PEOPLE WERE WANTING TO MAKE SURE THERE WAS TIME TO IMPLEMENT PROCEDURES, IN FACT, THEY DELAYED THE PUBLIC LAUNCH UNTIL NOVEMBER OF 2013; CORRECT?
ADAM ROSENDORFF: I CAN'T SPECULATE ON WHY THE PUBLIC LAUNCH WAS DELAYED, SIR.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I'M ALSO NOT CLEAR ON WHAT YOU MEAN BY "PUBLIC." YOU KNOW, FRIENDS AND FAMILY ARE STILL MEMBERS OF THE PUBLIC.
MR. WADE: RIGHT. SO -- I'M GLAD YOU RAISED THAT, BECAUSE YOU WERE ASKED SOME QUESTIONS ABOUT FRIENDS AND FAMILY.
ADAM ROSENDORFF: YEAH.
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE ASKED ABOUT IF THERE WERE ISSUES WITH THOSE TESTS OR THINGS, THOSE WOULD STILL BE REAL ISSUES; RIGHT? THEY'RE STILL PATIENTS; RIGHT, IF THEY'RE FRIENDS AND FAMILY? DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND THE GOVERNMENT SAID, AND IF ISSUES AROSE, EVEN WITH A SMALL VOLUME, THOSE ARE STILL ISSUES THAT ARE SERIOUS; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: NOW, YOU ACTUALLY DON'T KNOW OF ANY ISSUES THAT CAME UP WITH RESPECT TO THE LAB RESULTS THAT WERE ACTUALLY PERFORMED DURING THAT PUBLIC LAUNCH, DO YOU?
ADAM ROSENDORFF: I DON'T RECALL.
MR. WADE: YOU HAVEN'T BEEN SHOWN A SINGLE EMAIL THAT SUGGESTS THAT THERE WAS AN ISSUE WITH RESPECT TO THOSE FEW LAB TESTS THAT WERE OFFERED IN THAT FRIENDS AND FAMILY LAUNCH, HAVE YOU?
ADAM ROSENDORFF: SO FROM WHAT YOU SHOWED ME, IT LOOKS LIKE THEY WERE RUNNING CBC'S AND A1C'S FOR THE FIRST TWO WEEKS OR SO.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: THAT'S WHAT I BELIEVED, YES.
ADAM ROSENDORFF: WELL, I -- I HAD NO TRANSPARENCY, OR I WAS NOT AWARE OF EXACTLY WHAT THEY WERE OFFERING AT THAT TIME.
ADAM ROSENDORFF: YES.
MR. WADE: SO YOU WOULDN'T HAVE -- YOU WOULDN'T HAVE LET A TEST IN THE LAB IF THERE WAS NO VALIDATION REPORT, WOULD YOU?
ADAM ROSENDORFF: OF COURSE NOT.
MR. WADE: OKAY. AND YOU RECALL -- I'M HAPPY TO BRING UP THAT EMAIL -- BUT YOU RECALL THE EXCHANGE THAT YOU HAD WITH MR. BALWANI WHERE HE ASKED IF THERE WAS ANYTHING THAT YOU NEEDED IN ADVANCE OF THE GENERAL PUBLIC LAUNCH IN EARLY NOVEMBER OF 2013?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: FRIENDS AND FAMILY IS STILL THE PUBLIC.
MR. WADE: OKAY. LET'S BRING UP 24 -- 12464, WHICH IS IN EVIDENCE. LET'S LOOK AT THE BOTTOM. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: LET'S GO TO THE NEXT PAGE. DO YOU SEE THAT THIS WAS THE POINT IN WHICH THIS WAS OPEN TO PEOPLE OTHER THAN FRIENDS AND FAMILY; RIGHT, SIR?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: NOW, THE GOVERNMENT BROUGHT UP A SERIES OF DOCUMENTS. LET'S START WITH 4047, WHICH IS IN EVIDENCE. OKAY. YOU RECALL THAT THEY SHOWED YOU THIS ONE?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: NOW, LET'S BRING UP 12479. AND LET'S BLOW UP THE TOP. AND, AGAIN, THIS DOCUMENT THEY DIDN'T SHOW YOU, DID THEY?
ADAM ROSENDORFF: NO, I'VE SEEN IT BEFORE.
ADAM ROSENDORFF: NOT IN THE REDIRECT, NO.
MR. WADE: AND THEY DIDN'T EMPHASIZE THAT YOU HAD PREVIOUSLY TESTIFIED THAT MS. HOLMES SEEMED WILLING TO SHOW THEM THE LAB DOWNSTAIRS; RIGHT? YOU PREVIOUSLY TESTIFIED TO THAT?
ADAM ROSENDORFF: YES.
MR. WADE: YEAH. AND JUST SO WE'RE CLEAR, BECAUSE I -- YOU NEVER CONCEALED ANYTHING FROM THESE INSPECTORS; RIGHT, SIR?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
MR. WADE: RIGHT. AND WITH RESPECT TO THE EDISON LABS, YOU SHOWED THEM AN EDISON VALIDATION REPORT; RIGHT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES, YES.
MR. WADE: AND ARE YOU AWARE THERE WERE DETAILED -- THERE WAS DETAILED INFORMATION ABOUT THE EDISONS AND ITS WHOLE TEST MENU PROVIDED TO THE FDA AND CMS DURING THIS VERY SAME TIME PERIOD? ARE YOU AWARE OF THAT?
ADAM ROSENDORFF: I WAS AWARE THAT THERANOS WAS VOLUNTARILY SUBMITTING DATA TO THE FDA, OSTENSIBLY FOR THE PURPOSES OF GETTING FDA APPROVAL. I'M NOT REALLY SURE WHY THEY WERE DOING THAT. I'M NOT AWARE OF ANY DOCUMENTATION THAT WAS SENT TO CMS REGARDING THE EDISONS DURING THIS TIME.
MR. WADE: OKAY. YOU WEREN'T AWARE THAT THEY WERE DOING THAT BECAUSE YOU WEREN'T INVOLVED IN THOSE PROCESSES; CORRECT?
ADAM ROSENDORFF: I DON'T -- I DON'T RECALL.
MR. WADE: OKAY. AND -- BUT YOU WERE AWARE THAT YOU SHARED INFORMATION WITH THE INSPECTOR WHO WALKED IN THE DOOR IN 2013; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND IF SHE HAD ASKED YOU TO GO DOWNSTAIRS AND SEE THOSE DEVICES, YOU WOULD HAVE WALKED HER RIGHT DOWN; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. NOW, THE GOVERNMENT BROUGHT UP A LITTLE -- SOME TESTIMONY WHERE IT WAS COMPARING THERANOS DEVICES AND UNMODIFIED DEVICES; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DON'T RECALL.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: THAT WAS MY BELIEF, YES.
MR. WADE: AND THERE WAS A LOT OF VOLUME OF TESTING THAT WAS HAPPENING ON COMMERCIAL DEVICES AT THERANOS; CORRECT?
ADAM ROSENDORFF: CAN YOU BE MORE SPECIFIC?
MR. WADE: YEAH. THERE WAS A -- THERE WERE A MENU OF DIFFERENT TESTS THERE WERE BEING OFFERED; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND I FORGET THE EXACT NUMBER, BUT YOU SAID MAYBE SEVEN TO NINE TESTS WERE OFFERED ON THE EDISON; RIGHT?
ADAM ROSENDORFF: IN WHAT TIME PERIOD?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND WHAT -- THERE WERE MAYBE ANOTHER 50 TO 60 OF THE MODIFIED PREDICATES THAT WERE RUN ON THE ADVIA; IS THAT RIGHT?
ADAM ROSENDORFF: THERE WERE 50 TO 60 THAT WERE VALIDATED, I BELIEVE. I CAN'T TESTIFY HERE TODAY, MY RECOLLECTION IS NOT GOOD ENOUGH TO SAY HOW MANY WERE ACTUALLY DONE USING THE LDT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND I BELIEVE YOUR TESTIMONY IS THAT THERE WERE BASICALLY NO ISSUES WITH RESPECT TO THOSE TESTS; RIGHT?
ADAM ROSENDORFF: THE COMMERCIAL DEVICES?
ADAM ROSENDORFF: IN GENERAL, YES.
MR. WADE: OKAY. LET'S PULL UP 13893. YOU RECALL YOU WERE ASKED SOME QUESTIONS ABOUT THIS, THE ISE'S?
ADAM ROSENDORFF: YES.
MR. WADE: LET'S GO TO THE SECOND PAGE. THIS WAS THE REPORT OUT FROM DR. YOUNG. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND WE TESTIFIED -- WE HAD SOME DISCUSSION ABOUT THIS ON CROSS-EXAMINATION. DO YOU RECALL?
ADAM ROSENDORFF: I BELIEVE SO.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: BECAUSE EVEN THOUGH THERE HAD BEEN SOME SUCCESS, THERE WAS STILL A DESIRE TO CONTINUE TO IMPROVE THE ASSAY; CORRECT?
ADAM ROSENDORFF: YES.
MR. WADE: AND LET'S GO BACK TO THE FIRST PAGE. AND YOU -- IN THIS EMAIL, YOU CONGRATULATED DR. YOUNG ON HAVING CRACKED THIS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND WHEN YOU OFFERED THE TEST, YOU BELIEVED IN GOOD FAITH THAT IT WAS -- THAT THE PROBLEM HAD BEEN SOLVED?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. YOU WERE ASKED SOME QUESTIONS ON DIRECT ABOUT THE LIS, OR ON REDIRECT ABOUT THE LIS. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND ONE THING THE GOVERNMENT ASKED YOU ABOUT WAS WHETHER THE TEST RESULT INFORMATION THAT YOU WOULD GET FROM OTHER COMPANIES WAS STORED WITHIN LIS. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES, YES.
ADAM ROSENDORFF: YES.
MR. WADE: YEAH. WHEN -- BUT WHEN INQUIRIES OF THAT KIND WOULD COME IN AND YOU WOULD HAVE TO CONSIDER HOW THOSE RESULTS COMPARED TO THERANOS'S RESULTS, YOU'D HAVE TO GO AND PULL A WHOLE LOT OF INFORMATION FROM THE LIS INFORMATION SYSTEM; RIGHT?
ADAM ROSENDORFF: YES. I WOULD SEE HOW THE THERANOS RESULTS HAD BEEN TRENDING, I WOULD SEE HOW MANY ARE OUT OF REFERENCE RANGE, I WOULD DO AN INVESTIGATION.
ADAM ROSENDORFF: AT THE THERANOS COLLECTION SITE?
ADAM ROSENDORFF: OH, YEAH, THAT'S PART OF THE ACCESSION.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I DON'T RECALL. THAT'S NOT A REQUIREMENT.
ADAM ROSENDORFF: I -- I DON'T RECALL IF THE IMAGES WERE AVAILABLE IN LIS.
MR. WADE: YOU RECALL PULLING THOSE FOR PURPOSES OF LOOKING AT WHETHER THERE WAS HEMOLYSIS IN THE SAMPLE? YOU'D LOOK AT THE IMAGES OF THE SAMPLE?
ADAM ROSENDORFF: I THINK IT WAS CLOTTING, AND I THINK SOMEBODY SENT ME THOSE IMAGES.
ADAM ROSENDORFF: YES.
MR. WADE: YOU MIGHT LOOK AT A WHOLE HOST OF OTHER INFORMATION THAT YOU HAVE WITHIN THE LAB AT THERANOS; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THAT WOULD -- THE VAST MAJORITY OF THAT INFORMATION WOULD BE STORED WITHIN LIS; CORRECT?
ADAM ROSENDORFF: YES, YES.
MR. WADE: AND WITH RESPECT TO WHETHER -- HOW THE RESULTS COMPARED TO OTHER RESULTS, THAT'S NOT SOMETHING THAT YOU KNOW JUST FROM -- OFF THE CUFF; RIGHT? YOU NEED TO GATHER ALL THE RELEVANT FACTS TO KNOW IF YOU'RE COMPARING APPLES TO APPLES; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THERE IS -- I BELIEVE YOU'VE TESTIFIED BEFORE THERE'S ALWAYS VARIABILITY TO A DEGREE, OR OFTEN VARIABILITY BETWEEN TWO TESTS; RIGHT?
ADAM ROSENDORFF: CAN YOU CLARIFY YOUR STATEMENT?
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: MINOR VARIATIONS.
MR. WADE: MINOR VARIATIONS. AND SO THERE COULD BE DIFFERENT VARIATIONS THAT WOULD -- THAT MIGHT -- THAT YOU HAVE TO ASSESS WHEN YOU'RE CONSIDERING WHETHER OR NOT THE DIFFERENCES BETWEEN THE THERANOS TEST AND THE TEST AT ANOTHER LAB ARE MEANINGFUL; RIGHT?
ADAM ROSENDORFF: RIGHT. SO THE ONE ISSUE IS WHAT IS THE ERROR WITHIN THE SAME METHOD IF YOU REPEAT THE SAMPLE? THAT'S CALLED PRECISION. THE OTHER MEDICAL ISSUE IS IF YOU GET A VASTLY DIFFERENT RESULT DESPITE THE -- DESPITE THE SMALL AMOUNT OF ERROR THAT HAPPENS WITH A GOOD LABORATORY TEST -- GOOD LABORATORY TESTS DON'T HAVE VERY MUCH ERROR, RIGHT? SO AS A PHYSICIAN, I WOULD HAVE TO LOOK AT THE QUEST RESULTS, FOR INSTANCE, AND DETERMINE WHETHER THEY WERE COMPARABLE TO THE THERANOS RESULTS.
MR. WADE: AND BECAUSE SOMETIMES DIFFERENT METHODS REACH DIFFERENT RESULTS ON THE SAME BLOOD; RIGHT?
ADAM ROSENDORFF: THEY SHOULDN'T BE THAT DIFFERENT. NO, THEY SHOULDN'T BE.
MR. WADE: WELL, YOU'RE AWARE THAT THERE'S A WHOLE MOVEMENT WITHIN THE LAB, LABORATORY SCIENCE ABOUT HARMONIZATION OF DATA. ARE YOU AWARE OF THAT?
ADAM ROSENDORFF: I'M AWARE OF IT FOR A1C.
MR. WADE: OKAY. AND IT EXISTS FOR VITAMIN D AS WELL; RIGHT? AND ARE YOU AWARE THAT THERE ARE EFFORTS AND TASK FORCES THAT LOOK AT DIFFERENCES BETWEEN DATA AND TRY TO FIND WAYS TO MAKE -- TO HARMONIZE THEM ACCORDING TO ONE STANDARD; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: RIGHT. GO AHEAD.
MR. WADE: SO THAT'S WHY, WHEN YOU GET THAT INFORMATION IN, YOU HAVE TO ACTUALLY LOOK AT ALL OF THE RELEVANT FACTS BEFORE REACHING A JUDGMENT; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND AT THE TIME, JUST SO THE RECORD IS CLEAR, THAT WASN'T AN APPLICATION OF THE AAP POLICY; CORRECT?
MR. WADE: OKAY. AND IF THERE WAS CONFUSION AS A RESULT OF THAT, THAT PEOPLE THOUGHT THAT TESTS FAILED AAP OR PT, THEY WOULD BE MISTAKEN; CORRECT?
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: WELL, IT WAS A QC SPOT CHECK USING PT SAMPLES. SO I CAN UNDERSTAND THE LEVEL OF CONCERN THAT WAS IN THE COMPANY.
MR. WADE: WELL, AND YOU CAN UNDERSTAND WHY THERE WAS SOME CONFUSION; RIGHT? BECAUSE IT WAS PRECISION TESTING MATERIAL; RIGHT?
ADAM ROSENDORFF: PROFICIENCY.
ADAM ROSENDORFF: YES.
MR. WADE: BUT IT WASN'T BEING USED IN -- ACCORDING TO THE PROFICIENCY TESTING POLICY AT THERANOS; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. AND THE -- AGAIN, THAT PROFICIENCY TESTING POLICY AND THE IMPLEMENTATION OF IT WAS THE RESPONSIBILITY OF YOU AND MR. GEE AND OTHERS WITHIN THE LABORATORY; CORRECT?
ADAM ROSENDORFF: I THINK WE'VE DISCUSSED THE CHALLENGES AROUND THE IMPLEMENTATION.
MR. WADE: I THINK WE HAVE DISCUSSED THE CHALLENGES AROUND IMPLEMENTATION, BUT IT WAS YOUR RESPONSIBILITY; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND I ALSO BELIEVE THAT YOU'VE TESTIFIED THAT THERE WAS NOT A SINGLE EMAIL THAT YOU SENT ASKING FOR MORE RESOURCES FROM MS. HOLMES THAT WAS NOT RESPONDED TO; CORRECT?
ADAM ROSENDORFF: IT WAS DISCUSSED IN THE MEETING WITH -- IN THE AAP MEETING.
ADAM ROSENDORFF: YEAH.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I BELIEVE SO.
ADAM ROSENDORFF: IN -- ON REDIRECT?
ADAM ROSENDORFF: YEAH.
ADAM ROSENDORFF: UM-HUM.
ADAM ROSENDORFF: YES.
MR. WADE: AND THERE WAS DISCUSSION OF -- WITH MR. BOSTIC ABOUT YOUR RESPONSIBILITY UNDER THOSE REGULATIONS; CORRECT?
ADAM ROSENDORFF: YES.
MR. WADE: AND HE ASKED YOU ABOUT -- YOU NOTED THE FACT THAT THE OWNER AND OPERATOR IS RESPONSIBLE; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CLIA DOES NOT USE THE WORD "AUTHORITY" OR ADDRESS AUTHORITY IN THE REGULATIONS.
MR. WADE: RIGHT. THAT'S MY POINT. THE RESPONSIBILITY FOR ACTUALLY DOING THE FUNCTIONS IS THE LAB DIRECTOR'S; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THE RESPONSIBILITY FOR IMPLEMENTING ALL OF THE PROCEDURES IS THE LAB DIRECTOR'S; RIGHT?
ADAM ROSENDORFF: I TAKE OBJECTION TO YOUR INFERENCE THAT I WAS RESPONSIBLE FOR THE EXECUTION OF THESE PROCEDURES.
MR. WADE: WELL, ULTIMATELY THE REGULATIONS THERE SAY THAT IT IS YOUR RESPONSIBILITY UNDER THE FEDERAL CLIA REGULATIONS TO IMPLEMENT QUALITY CONTROL, AAP, TEST VALIDATION AND VERIFICATION, AND OTHER ITEMS; CORRECT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: AND THE OWNER/OPERATOR.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND JUST BECAUSE SOMEONE IS AN OWNER/OPERATOR DOESN'T MEAN THEY CAN COME IN AND BE A LAB DIRECTOR; RIGHT?
MR. WADE: RIGHT. SO IF THE OWNER/OPERATOR CAME IN AND STARTED SAYING, LET'S OFFER THESE TESTS, THAT WOULD BE WRONG; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND IF THE OWNER/OPERATOR CAME IN AND STARTED ISSUING DIRECTIVES AND TELLING YOU EXACTLY WHAT TO DO WITHOUT THE REQUISITE TRAINING, THAT WOULD BE WRONG; RIGHT, SIR?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND MS. HOLMES NEVER DID THAT; RIGHT? SHE NEVER DIRECTED YOU TO DO THINGS OR OVERRULED YOU ON THINGS, DID SHE?
ADAM ROSENDORFF: YES.
MR. WADE: AND THE GIST OF THE QUESTIONS RELATED TO KIND OF WHAT WAS HAPPENING IN THIS FIRST WEEKEND IN JUNE WHEN YOU PUT A HALT TO REPORTING RESULTS FROM THE EDISON ON HCG; RIGHT?
ADAM ROSENDORFF: IT WAS MAY 30TH.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: I BELIEVE SO.
MR. WADE: AND I THINK MAYBE EVEN ON THAT DAY, THEY WERE TEMPORARILY HALTED, AND THEN IT WAS PERMANENTLY HALTED THE NEXT DAY; RIGHT?
ADAM ROSENDORFF: TO BE HONEST, REVIEWING THE EMAILS, I'M NOT SURE WHAT WAS -- I'M NOT SURE -- I'VE SEEN EMAILS TO THE EFFECT THAT THEY CONTINUED RUNNING THEM ON EDISONS. I WAS SEEKING CLARIFICATION OF WHAT METHOD WE WERE ACTUALLY USING. DANIEL WAS CLAIMING THAT HE WASN'T INFORMED THAT THE HCG SHOULD GO ON THE EDISONS. SO IT'S A LITTLE UNCLEAR TO ME.
MR. WADE: RIGHT. AND I THINK YOU TESTIFIED YOU ACTUALLY -- APART FROM THESE EMAILS, YOU DON'T HAVE ANY RECOLLECTION OF THIS; RIGHT?
ADAM ROSENDORFF: I -- I DO NOT HAVE INDEPENDENT -- I REMEMBER THERE WAS A PROBLEM WITH THE HCG.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. LET'S LOOK -- I JUST WANT TO GO THROUGH -- I'VE CREATED A DEMONSTRATIVE WHICH I'LL PUT UP, WHICH IS JUST EXCERPTS FROM EMAILS THAT ARE IN EVIDENCE, AND I'M GOING TO HAND IT TO YOU IN A SECOND. I JUST WANT TO TELL YOU WHAT IT IS. OKAY? YOU RECALL THAT THERE'S A LITTLE BIT OF CONFUSION AROUND THIS ISSUE BECAUSE THERE ARE SEVERAL DIFFERENT EMAIL STRINGS THAT ARE FROM DIFFERENT -- THAT HAVE DIFFERENT TIMED EMAILS ON IT AND THEY'RE ALL KIND OF FLYING AROUND AT THE SAME TIME. DO YOU RECALL THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. WHAT WE'VE DONE IS WE'VE GONE THROUGH THOSE THREE DIFFERENT EXHIBITS AND WE'VE JUST PUT THEM IN ORDER, OKAY, ACCORDING TO THE TIME ON THE EMAILS. OKAY?
ADAM ROSENDORFF: OKAY.
JUDGE DAVILA: YES.
ADAM ROSENDORFF: YOUR HONOR, I HAVE TO PICK UP MY DAUGHTER AT 3:45 AND I RESPECTFULLY ASK THE COURT THAT I BE EXCUSED AT 2:00 O'CLOCK.
JUDGE DAVILA: ALL RIGHT. THANK YOU FOR LETTING ME KNOW THAT. THANK YOU.
ADAM ROSENDORFF: THANK YOU.
MR. WADE: YOUR HONOR, 2:00 O'CLOCK SHOULD NOT BE AN ISSUE FROM OUR STANDPOINT. I HOPE TO BE DONE WELL BEFORE 2:00 O'CLOCK.
JUDGE DAVILA: OKAY.
COURT CLERK: I'M JUST CONFIRMING THAT THIS CAN BE DISPLAYED.
MR. BOSTIC: NO OBJECTION FROM THE GOVERNMENT, YOUR HONOR.
BY MR. WADE:
MR. WADE: OKAY. AND, AGAIN, ALL OF THESE EXHIBITS, I'M NOT -- I'M TRYING TO SIMPLIFY THIS A LITTLE BIT. BUT IF IT'S EVER CONFUSING AND YOU WANT TO LOOK BACK AT THE INDIVIDUAL EXHIBITS, FEEL FREE. OKAY?
ADAM ROSENDORFF: SURE THING.
ADAM ROSENDORFF: UM-HUM.
MR. WADE: AND IN 5419, THIS IS -- I'M JUST PICKING UP AT THE TIME OF YOUR DIRECTION. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND YOU SAY IN THAT FIRST ENTRY, "ALL FURTHER HCG TESTING (CTN OR VACUTAINER) IS TO BE RUN ON THE IMMULITE." RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: BECAUSE THE MOST IMPORTANT THING IS YOU WANT TO MAKE SURE -- YOU DIDN'T WANT TO MAKE SURE THAT THERE WERE -- THAT THE ACTUAL RESULTS WENT OUT THE DOOR UNTIL THE ISSUE WAS UNDERSTOOD; CORRECT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. AND THEN YOU TALKED ABOUT THE NEED TO GO BACK AND MAKE CONTACT IF THERE WAS A NEED FOR A REDRAW DUE TO INSUFFICIENT VOLUME FOR THE IMMULITE. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. IF WE GO TO THE NEXT EMAIL ON THE CHAIN, YOU CAN SEE THAT'S JUNE 4TH AT 5:03. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND MS. ALAMDAR NOTES THAT THERE WERE SOME RESULTS IN LIS FOR HCG FOR EDISON. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: SHE WAS ON THE CLS EMAIL DISTRIBUTION LIST, YES, SHE WAS.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I'M JUST REALLY CONFUSED AS TO WHY THE TEST WAS RUN ON THE EDISON AND ON THE IMMULITE AT THIS TIME.
ADAM ROSENDORFF: CORRECT.
MR. WADE: AND IT MAY HAVE BEEN THAT IT TOOK AWHILE TO GET OUT TO THE PATIENT SERVICE CENTERS TO REVISE THE METHOD FOR HCG; RIGHT? THEY MIGHT HAVE KEPT GOING FOR AWHILE WITH CTN'S?
ADAM ROSENDORFF: IT'S POSSIBLE.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: AND I DON'T KNOW THAT WE HAVE A RESPONSE, BUT SHE'S DIRECTING THAT INQUIRY TO YOU; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND THAT SAYS THAT DANIEL -- DANIEL REPORTS TO MR. BALWANI THAT HE WAS JUST SPEAKING WITH YOU ABOUT THIS. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: AND DO YOU RECALL THERE WAS THAT EMAIL WHERE MR. BALWANI WAS KIND OF MAD, HE WANTED TO MAKE SURE HE GOT YOU IN THE LOOP WITH DANIEL, WITH DR. YOUNG AND DR. PANGARKAR?
ADAM ROSENDORFF: SEPARATE ISSUE.
ADAM ROSENDORFF: I RECALL AN EMAIL ABOUT R&D RUNNING EXPERIMENTS IN THE CLIA LAB AND ME WANTING TO BE INFORMED OF THAT.
MR. WADE: RIGHT. AND DO YOU RECALL THOSE WERE HCG RESULTS RELATING TO A STUDY THEY WERE DOING RIGHT IN THIS SAME TIME PERIOD?
ADAM ROSENDORFF: I DON'T RECALL.
MR. WADE: OKAY. WE'LL KEEP GOING. DO YOU SEE THEN THE NEXT EMAIL IN THAT CHAIN, WHICH IS AT 5:12 -- OH, BY THE WAY, THE PRIOR EMAIL, IT SAYS, "WE WILL HOLD THE RESULT," THE EMAIL FROM DANIEL, IT SAYS, "WE WILL HOLD THE RESULT UNTIL THE STUDY WE ARE RUNNING ON THE EDISON ASSAY IS DONE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: IT'S NOT CLEAR TO ME FROM DANIEL'S EMAIL WHAT RESULT HE'S REFERRING TO, WHETHER IT'S RESULTS FROM THE IMMULITE OR RESULTS FROM EDISON.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. BUT I -- FAIR POINT. IT'S NOT CLEAR; RIGHT? BUT HE SAYS HE'S HOLDING RESULTS UNTIL THE STUDY IS DONE?
ADAM ROSENDORFF: YEAH. SO WHY IS HE WEIGHING IN ABOUT WHAT RESULTS SHOULD BE HELD AND WHAT SHOULD BE RELEASED?
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: I DON'T RECALL.
ADAM ROSENDORFF: I'M SORRY?
ADAM ROSENDORFF: THAT'S A VERY BROAD STATEMENT.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. LET'S GO TO THE NEXT EMAIL. AND IT SAYS -- THAT'S AN EMAIL FROM, IN RESPONSE TO THE PRIOR ONE THAT SAYS, FROM DANIEL YOUNG, "BY THE WAY, WE NEVER SWITCHED TO IMMULITE IN LIS - IT WAS NOT CLEAR TO ME THAT THIS DECISION WAS MADE." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: I THINK HE'S TALKING ABOUT THE DECISION TO SWITCH HCG ONTO THE IMMULITE.
MR. WADE: RIGHT. AND THAT'S WHETHER OR NOT IT WOULD BE COMMUNICATED OUT TO THE PATIENT SERVICE CENTERS TO ALTER THE DRAW METHOD; RIGHT?
ADAM ROSENDORFF: THAT WOULD BE PART OF IT, YEAH.
ADAM ROSENDORFF: I DON'T KNOW IF DANIEL WAS ON THE CLS DISTRIBUTION LIST. I JUST DON'T REMEMBER THAT.
MR. WADE: BUT HE'S NOT SAYING THERE THAT YOU'RE GOING TO RELEASE ANY RESULTS; RIGHT? IT'S JUST A QUESTION OF WHETHER THAT CHANGE IN COLLECTION METHOD HAD BEEN IMPLEMENTED IN LIS; RIGHT?
ADAM ROSENDORFF: I DON'T UNDERSTAND YOUR QUESTION.
ADAM ROSENDORFF: WELL, HE MIGHT BE -- I DON'T KNOW. HE MIGHT BE STILL AUTHORIZING RELEASE OF IMMULITE RESULTS. I JUST DON'T -- IT'S NOT CLEAR TO ME.
ADAM ROSENDORFF: I CAN'T ANSWER YES OR NO.
ADAM ROSENDORFF: NO. IT WAS SEVEN YEARS AGO.
ADAM ROSENDORFF: MORE THAN SEVEN YEARS AGO.
MR. WADE: LET'S JUST KEEP LOOKING AT THE EMAILS, BECAUSE I BELIEVE THAT'S WHAT YOU'VE BEEN TESTIFYING ABOUT AND I JUST WANT TO MAKE SURE THE RECORD IS CLEAR ON THE EMAILS. OKAY?
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND ALTHOUGH THERE ARE SEPARATE EMAIL CHAINS GOING, YOU'RE BOTH REFERRING TO DISCUSSIONS YOU'RE HAVING WITH EACH OTHER; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU -- I TAKE IT IF YOU WROTE THAT YOU WERE DISCUSSING THAT WITH THEM, YOU BELIEVED THAT TO BE TRUE AT THE TIME?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: SIR, TO -- I BELIEVE WE'VE GONE OVER THIS EMAIL BEFORE IN YOUR PRIOR QUESTIONING. IS IT NECESSARY TO REVISIT IT?
JUDGE DAVILA: HE GETS TO ASK YOU QUESTIONS.
ADAM ROSENDORFF: OKAY.
BY MR. WADE:
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND THAT'S EXHIBIT 5419. THAT'S AN EMAIL WHERE HE'S TALKING ABOUT THE STUDY THAT'S BEING DONE?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND WE HAVE JUST TWO MORE. I'LL BRING YOU TO THE NEXT PAGE. THIS IS NOW AT 6:29 P.M.; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: BUT JUST AFTER THAT, IT'S THE NEXT EMAIL SEQUENTIALLY. DANIEL NOTES THAT THEY'RE REPEATING THE IQP; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND THEN HE NOTES, IF WE NEED TO COLLECT THE VACUTAINERS TOMORROW, WE'LL NEED TO SEND SPECIAL INSTRUCTIONS TO THE PSC'S; RIGHT? DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND SO WHAT HE'S SAYING IS THERE'S BASICALLY A HOLD, AND IF WE DECIDE WE NEED REDRAWS SO THAT WE CAN SWITCH THIS, THE CTN'S THAT WERE GOING TO THE EDISONS TO VACUTAINERS, WE'LL DO IT; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: MY READING OF THIS IS THAT HE'S UNWILLING TO TELL THE PSC'S TO SWITCH TO VACUTAINERS.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND WHAT HE'S -- ISN'T WHAT HE'S ESSENTIALLY SAYING IS LET'S -- WE'RE ALMOST DONE, LET'S WAIT AND SEE WHAT IT SHOWS?
ADAM ROSENDORFF: YES.
MR. WADE: AND IF WE DON'T NEED TO GO OUT AND BOTHER THESE PEOPLE TO GET ANOTHER BLOOD DRAW, WE WON'T DO IT; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: THAT'S -- THAT'S AN INFERENCE.
MR. WADE: IT SAYS, IF WE NEED TO COLLECT VACUTAINERS TOMORROW, WE WOULD NEED TO SEND SPECIAL INSTRUCTIONS TO THE PSC'S; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND THEN THE LAST EMAIL IN THIS CHAIN JUST RELATES TO HOW THAT WILL WORK WITHIN THE OPERATIONAL COMPONENTS OF THE LIS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: THERE'S NOTHING IN ANY OF THESE EMAILS THAT SAYS THAT THEY'RE GOING TO RELEASE RESULTS; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: OKAY. AND THERE'S NOTHING IN ANY OF THESE EMAILS THAT SUGGESTS THAT YOUR DIRECTION, WHICH WAS THE FIRST EMAIL IN THE CHAIN, HAS BEEN COUNTERMANDED; RIGHT?
ADAM ROSENDORFF: I'M NOT SURE IF THE CLS'S WERE RELEASING RESULTS BETWEEN MAY 30TH AND JUNE 4TH. I JUST DON'T KNOW.
MR. WADE: WELL, YOU SEE THAT THEY'RE, THEY'RE ASKING YOU QUESTIONS ABOUT WHETHER THEY CAN RELEASE RESULTS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: TO NOT RELEASE RESULTS.
MR. WADE: OKAY. AND THE GOVERNMENT ALSO SHOWED YOU SOME DOCUMENTS THAT RELATED TO QC THAT WAS PERFORMED. DO YOU RECALL THAT? ON THE EDISONS IN JUNE OF 2014?
ADAM ROSENDORFF: ON REDIRECT?
ADAM ROSENDORFF: ON REDIRECT?
ADAM ROSENDORFF: YES, I THINK AT THE VERY -- AT THE VERY BEGINNING OF THE DAY, YES.
MR. WADE: OKAY. AND YOU'LL RECALL, MUCH OF THE QUESTIONING ON CROSS-EXAMINATION CAME UP BECAUSE THE QUESTION WAS ASKED OF YOU IN YOUR DIRECT EXAMINATION WHETHER YOU KNEW ABOUT THE FACT THAT HCG WENT BACK ONTO EDISONS AFTER YOU ISSUED THAT DIRECTIVE AND YOU SAID YOU WERE UNAWARE OF THAT; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND I SHOWED YOU SOME DOCUMENTS IN CROSS-EXAMINATION THAT SUGGESTED YOU PROBABLY WERE AWARE IN MID TO LATE MARCH; RIGHT? DO YOU RECALL THAT?
ADAM ROSENDORFF: MY ORDER TO CEASE TESTING FOR HCG ON THE EDISONS WENT OUT ON MAY 30TH.
MR. WADE: RIGHT. AND DO YOU RECALL IN CROSS-EXAMINATION I SHOWED YOU MANY EMAILS FROM MID TO LATE MARCH THAT INDICATED THAT EDISON WAS BACK ON? DO YOU RECALL THAT?
ADAM ROSENDORFF: I'M SORRY. MARCH IS BEFORE MAY.
ADAM ROSENDORFF: I DON'T UNDERSTAND YOUR TIMELINE.
ADAM ROSENDORFF: YOU REALLY ARE.
MR. WADE: YEAH, I AM. THANKS. LET ME TRY IT AGAIN. I SHOWED YOU A NUMBER OF EMAILS IN MID TO LATE JUNE --
ADAM ROSENDORFF: YES.
MR. WADE: -- THAT SUGGESTED THAT YOU WERE AWARE THAT EDISON HCG TESTS WERE BACK UP AND RUNNING; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: CORRECT.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. LET'S LOOK AT EXHIBITS 5421 AND 5422. NOW, THESE ARE GOVERNMENT EXHIBITS ABOUT THE QUALITY CONTROL ON EDISONS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND SO WHEN THE GOVERNMENT WAS ASKING YOU QUESTIONS, THEY KNEW THAT HCG HAD COME BACK UP ON EDISONS AND THAT YOU WERE AWARE OF IT BECAUSE THEY HAD THESE EMAILS, BUT THEY DIDN'T SHOW YOU THESE EMAILS, DID THEY?
ADAM ROSENDORFF: THIS EMAIL SAYS THAT NINE EDISONS ARE FAILING LEVEL 1 FOR HCG.
MR. WADE: RIGHT. BUT IT SAYS THEY'RE BRINGING UP HCG ON EDISONS; RIGHT? ISN'T THAT THE IMPLICATION OF THIS EMAIL?
ADAM ROSENDORFF: IT SAYS INSTRUMENT BRING UP.
ADAM ROSENDORFF: THEY'RE TRYING TO.
ADAM ROSENDORFF: BUT IT -- THIS EMAIL INDICATES THAT HCG DID NOT PASS QUALITY CONTROL.
ADAM ROSENDORFF: THE ONE ON THE LEFT.
MR. WADE: THE ONE ON THE LEFT. RIGHT. AND IT INDICATES THAT WITHIN THE LABORATORY BRING UP, THEY'RE WORKING TO GET THE HCG UP ONTO THE EDISON; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: YEAH. AND WE SAW THE OTHER DOCUMENTS WHERE YOU KNEW THAT THE GOVERNMENT DIDN'T SHOW YOU; RIGHT? THE OTHER DOCUMENTS WHERE YOU KNEW IN LATE JUNE THAT HCG WAS BROUGHT UP ON THE EDISON?
ADAM ROSENDORFF: THESE EMAILS SHOW THAT QC WAS BEING RUN FOR HCG ON THE EDISONS.
MR. WADE: SIR, THE GOVERNMENT NEVER SHOWED YOU THESE EMAILS ON YOUR DIRECT TESTIMONY WHEN YOUR TESTIMONY WAS IN ERROR; RIGHT?
ADAM ROSENDORFF: CORRECT.
MR. WADE: YEAH. AND BY THE WAY, THOSE -- THE QUALITY CONTROL RESULTS THAT WERE DEPICTED IN THOSE DOCUMENTS, YOU WERE GETTING THEM IT LOOKED LIKE DAILY; RIGHT? THEY SHOWED YOU A COUPLE OF DAYS WORTH OF THOSE EMAILS FROM MR. GEE; RIGHT?
ADAM ROSENDORFF: NO, I WAS NOT RECEIVING QC INFORMATION DAILY FROM MR. GEE, NO.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: JUST IN THAT TIME PERIOD, THE 6-24 TIME PERIOD, 6-24, 6-25, YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND WE'VE TALKED ABOUT HOW YOU GOT OTHER INFORMATION FROM MR. GEE ON QUALITY CONTROL; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND IF YOU HAD ANY CONCERNS AS A RESULT OF THAT INFORMATION ABOUT THE ACCURACY AND RELIABILITY OF THE TEST, YOU WOULD HAVE TAKEN ACTION IMMEDIATELY; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND THAT'S TRUE GENERALLY WITH RESPECT TO CONCERNS, BECAUSE YOU TALKED SOMETIMES ABOUT CONCERNS -- AND MAYBE IT COMES UP WITH THE BENEFIT OF HINDSIGHT OR SOMETHING -- BUT WHEN YOU WERE IN THE LAB IN REAL TIME, IF THERE WAS A CONCERN ABOUT THE ACCURACY OR RELIABILITY OF A TEST, YOU ACTED ON IT; RIGHT?
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WERE THE MOST KNOWLEDGEABLE, QUALIFIED, COMPETENT PERSON TO ACT IN THAT REGARD WITHIN THERANOS; RIGHT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: AND YOU WENT BACK ESSENTIALLY TO THE TESTIMONY THAT THE COMPLAINTS WERE MORE FREQUENT AT THERANOS THAN THEY WERE AT THE UNIVERSITY OF PITTSBURGH. DO YOU RECALL THAT?
ADAM ROSENDORFF: ON A PERCENTAGE BASIS, YES.
ADAM ROSENDORFF: ON A PERCENTAGE BASIS.
MR. WADE: AND YOU RECALL I SHOWED YOU YESTERDAY YOUR TESTIMONY FROM 2019 IN WHICH YOU SAID THAT THE DOCTOR COMPLAINTS WERE NOT MORE FREQUENT; RIGHT?
ADAM ROSENDORFF: JUST IN TERMS OF THE NUMBER OF COMPLAINTS. I BELIEVE I CLARIFIED MY MEANING.
MR. WADE: RIGHT. YOU TESTIFIED THAT -- WELL, WE CAN LOOK AT IT. LET'S LOOK AT IT. 11000, WHICH IS IN YOUR YELLOW BINDER. AND IT'S PAGE 122, DOCTOR.
ADAM ROSENDORFF: OKAY.
ADAM ROSENDORFF: YES.
MR. WADE: DOES THIS REFRESH YOUR RECOLLECTION THAT YOU WERE ASKED, "WERE THESE TYPES OF PHYSICIAN COMPLAINTS COMMON DURING YOUR TIME AT THERANOS?" AND YOU ANSWERED, "THEY WEREN'T MORE COMMON THAN WHAT ONE USUALLY SEES IN SOME LABS WITH HIGH VOLUME." DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND YOU WERE ASKED IN THE NEXT QUESTION AND ANSWER ABOUT HOW IT COMPARED TO YOUR TIME -- OR YOU OFFERED A COMPARISON TO YOUR TIME AT UNIVERSITY OF PITTSBURGH. DO YOU SEE THAT?
ADAM ROSENDORFF: YES.
MR. WADE: OKAY. AND YOU TESTIFIED THAT THEY WERE NOT MORE ANOMALOUS THAN WHAT YOU SAW AT THE UNIVERSITY OF PITTSBURGH; CORRECT?
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
ADAM ROSENDORFF: YES.
JUDGE DAVILA: MR. BOSTIC?
MR. BOSTIC: NO FURTHER QUESTIONS, YOUR HONOR. THANK YOU.
JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?
MR. BOSTIC: FROM THE GOVERNMENT'S PERSPECTIVE, YES.
JUDGE DAVILA: YOU'RE EXCUSED, SIR. THANK YOU.
ADAM ROSENDORFF: THANK YOU VERY MUCH, YOUR HONOR.
JUDGE DAVILA: YOU'RE WELCOME. DOES THE GOVERNMENT HAVE ANOTHER WITNESS?
MR. LEACH: WE DO, YOUR HONOR. THE UNITED STATES CALLS STEVE BURD.
COURT CLERK: YOUR HONOR, I NEED A FEW MINUTES TO COLLECT THESE ITEMS.
JUDGE DAVILA: OKAY. ARE THESE -- ARE THESE YOUR DOCUMENTS HERE? THANK YOU.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: SIR, JUST GIVE ME JUST A MOMENT. IF YOU WOULD JUST WAIT JUST A MOMENT, SIR. JUST HANG ON A SECOND.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: LADIES AND GENTLEMEN, STAND UP AND STRETCH IF YOU'D LIKE FOR A MOMENT.
(STRETCH BREAK.)
JUDGE DAVILA: WE'RE GOING TO BREAK AT 3:00 O'CLOCK. I UNDERSTAND WE'LL PROBABLY TAKE A BRIEF RECESS IN ABOUT 20 MINUTES, LADIES AND GENTLEMEN. IT'LL BE A BRIEF RECESS AND THEN WE'LL CONTINUE. ALL RIGHT. SIR, IF YOU'D COME FORWARD, PLEASE. PLEASE BE SEATED. THANK YOU. IF YOU'D COME FORWARD. AND IF YOU WOULD FACE OUR COURTROOM DEPUTY AND RAISE YOUR RIGHT HAND, SHE HAS A QUESTION FOR YOU.
ADAM ROSENDORFF: OKAY.
(GOVERNMENT'S WITNESS, STEVE BURD, WAS SWORN.)
ADAM ROSENDORFF: YES.
JUDGE DAVILA: THANK YOU, SIR. LET ME INVITE YOU TO TAKE A SEAT HERE AND MAKE YOURSELF COMFORTABLE. FEEL FREE TO ADJUST THE CHAIR AND MICROPHONE AS YOU NEED, AND I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE. WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME AND THEN SPELL IT, PLEASE.
ADAM ROSENDORFF: SURE. MY NAME IS STEVE BURD, SPELLED S-T-E-V-E, LAST NAME B-U-R-D.
JUDGE DAVILA: THANK YOU. COUNSEL.
MR. LEACH: THANK YOU, YOUR HONOR.