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Elizabeth Holmes- Case Archive
Federal Criminal TrialtranscripttranscriptAdam Rosendorff — Cross (Recall) - Day 14 - Federal Criminal TrialCourt convened with the jury before Adam Rosendorff's cross-examination resumed on proficiency policies, Edison assay practices, HCG testing, and physician complaints. The court conditionally admitted limited calendar information subject to later foundation.
John C. BosticKatherine TrefzLance A. WadeEdward J. DavilaAdam RosendorffJudge DavilaAdam RosendorffMr. WadeCourt ClerkJurorMr. BosticMs. Trefzproceduralcrosscolloquy
Federal Criminal Trial/Day 14/October 1, 2021
1 page·1 witness·2,301 lines
Court convened with the jury before Adam Rosendorff's cross-examination resumed on proficiency policies, Edison assay practices, HCG testing, and physician complaints. The court conditionally admitted limited calendar information subject to later foundation.
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Crosscolloquy

Adam Rosendorff — Cross (Recall)

Lance A. Wade Adam Rosendorff
2,301 lines
Proceedings
Procedural 1Court Convenes and Jury ReturnsLine 1
Procedural 2Juror Exposure Inquiry and Trial ScheduleLine 11
Cross 1Adam Rosendorff — CrossLine 14
colloquyAdmissibility Colloquy Regarding Defense Exhibit 13862Line 24
Cross 2Adam Rosendorff — Cross ResumedLine 19
Procedural 1Proc. 1Court Convenes and Jury Returns
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SAN JOSE, CALIFORNIA OCTOBER 1, 2021 P R O C E E D I N G S

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(COURT CONVENED AT 9:01 A.M.)

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(JURY IN AT 9:01 A.M.)

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JUDGE DAVILA: WE'RE BACK ON THE RECORD IN UNITED STATES VERSUS HOLMES. ALL COUNSEL ARE PRESENT. MS. HOLMES IS PRESENT. OUR JURY AND ALTERNATES ARE PRESENT. GOOD MORNING. THE WITNESS IS ON THE STAND. GOOD MORNING, DOCTOR.

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ADAM ROSENDORFF: GOOD MORNING.

Procedural 2Proc. 2Juror Exposure Inquiry and Trial Schedule
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JUDGE DAVILA: BEFORE WE BEGIN, LADIES AND GENTLEMEN OF THE JURY, LET ME ASK YOU THAT QUESTION AGAIN, AND THANK YOU FOR YOUR PATIENCE. DURING OUR BREAK I'M CURIOUS TO KNOW WHETHER ANY OF YOU WERE SUBJECT TO OR HAVE HAD CAUSE TO HEAR, LISTEN TO, VIEW, HEAR, READ, OR HAVE COMMUNICATION IN ANY WAY ABOUT ANY MATTER OR ISSUE INVOLVING THIS CASE? AGAIN, IF ANYONE WISHES TO SPEAK PRIVATELY, PLEASE LET ME KNOW THAT. IF ANYONE HAS HAD OCCASION TO RECEIVE INFORMATION ABOUT THIS CASE, PLEASE RAISE YOUR HAND NOW. I SEE NO HANDS. THANK YOU. BEFORE WE RESUME OUR EXAMINATION, I JUST WANT TO REVIEW OUR SCHEDULE FOR NEXT WEEK, LADIES AND GENTLEMEN. LADIES AND GENTLEMEN, NEXT WEEK WE'RE GOING TO HAVE A LONG WEEKEND. WE WILL NOT BE IN SESSION THURSDAY THE 7TH NOR WILL WE BE IN SESSION FRIDAY THE 8TH. THE 11TH IS A HOLIDAY, SO WE WILL NOT BE IN SESSION ON MONDAY THE 11TH. WE WILL RESUME THE TRIAL ON THE 12TH, THE 12TH OF OCTOBER. I JUST SHARE THAT WITH YOU AND COUNSEL FOR YOUR INFORMATION. AND WE'RE IN OCTOBER ALREADY, AREN'T WE? MY GOODNESS. THE WITNESS IS ON THE STAND. YOU'RE STILL UNDER OATH, SIR.

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(GOVERNMENT'S WITNESS, ADAM ROSENDORFF, WAS PREVIOUSLY SWORN.)

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JUDGE DAVILA: DID YOU HAVE A FEW MORE QUESTIONS, MR. WADE?

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MR. WADE: I DO, YOUR HONOR.

Cross 1Cross 1 Adam Rosendorff Lance A. Wade
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CROSS-EXAMINATION (RESUMED) BY MR. WADE:

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MR. WADE: GOOD MORNING, DR. ROSENDORFF.

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ADAM ROSENDORFF: GOOD MORNING.

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MR. WADE: I'D LIKE TO JUST RESET THE TABLE WHERE WE ENDED UP LAST WEEK OR THE LAST SESSION IF THAT'S OKAY?

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MR. WADE: WE WERE TALKING ABOUT PROFICIENCY TESTING. DO YOU RECALL THAT?

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MR. WADE: AND PROFICIENCY TESTING IS A PERIODIC PROCESS TO CHECK THE ACCURACY AND PRECISION OF TESTS IN A CLINICAL LABORATORY; CORRECT?

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MR. WADE: AND IN STANDARD PROFICIENCY TESTING THE LAB RECEIVES SAMPLES FROM AN OUTSIDE AGENCY; RIGHT?

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MR. WADE: AND THEY'RE NOT PATIENT SAMPLES?

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MR. WADE: THEY'RE SYNTHETIC?

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MR. WADE: ARTIFICIAL?

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MR. WADE: AND THEY HAVE PRESERVATIVES AND BUFFERS AND SPECIAL PROTEINS; CORRECT?

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MR. WADE: AND FOR THERANOS'S PROPRIETARY TESTS, IT WAS APPROPRIATE TO USE AN ALTERNATIVE ASSESSMENT OF PROFICIENCY, OR AAP, PROGRAM THAT THERANOS DEVELOPED INTERNALLY; CORRECT?

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ADAM ROSENDORFF: I CAN'T ANSWER THAT YES OR NO.

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MR. WADE: OKAY. WELL, YOU RECALL THE LAST SESSION THAT WE WERE TALKING ABOUT AAP; CORRECT?

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MR. WADE: AND WE WERE LOOKING AT SOME EMAILS WITH YOU AND MR. YOUNG, DR. YOUNG. DO YOU RECALL THAT?

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MR. WADE: AND IT WAS THE AAP PROGRAM THAT THE COMPANY PUT THAT POLICY IN PLACE WITH RESPECT TO THE EDISON ASSAYS. DO YOU RECALL THAT?

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ADAM ROSENDORFF: I WROTE AN SOP FOR AAP. DANIEL WROTE AN EMAIL WITH SUGGESTIONS AS TO HOW THAT WOULD HAPPEN. THE ACTUAL IMPLEMENTATION WAS STILL BEING DISCUSSED AT THE TIME WHEN DANIEL SENT HIS EMAIL.

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MR. WADE: AND WE'LL COME BACK THERE IN ONE SECOND. BUT UNDER THE CLIA REGULATIONS, THE LAB IS NOT REQUIRED TO DO PROFICIENCY TESTING ON EVERY TESTING METHOD IT HAS AVAILABLE TO IT; CORRECT?

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ADAM ROSENDORFF: UM, UNDER CLIA THERE ARE WHAT ARE CALLED CMS REGULATED ANALYTES AND CMS LISTS THOSE ANALYTES IN THE CODE OF FEDERAL REGULATIONS. THOSE ARE THE ANALYTES FOR WHICH PROFICIENCY TESTING IS REQUIRED BY LAW AND THE AGENCIES THAT YOU HAD MENTIONED WOULD REPORT ANY FAILURES TO CMS WITH REGARDS TO THOSE ANALYTES.

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MR. WADE: RIGHT. BUT AND MY POINT IS THAT YOU ONLY HAVE TO DO PROFICIENCY TESTING IF THE TESTING METHOD IS YOUR PRIMARY METHOD; CORRECT?

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MR. WADE: NOW, YOU MENTIONED SOME OF YOUR DISCUSSIONS IN THE EMAILS WITH DR. YOUNG. LET'S GO BACK AND MAKE SURE WE'RE ON THE SAME PAGE THERE. IF YOU COULD PULL UP EXHIBIT 4044, OR WE'LL PULL IT UP ON THE SCREEN. IT'S IN EVIDENCE. I BELIEVE IT'S ON YOUR SCREEN, DOCTOR, IF THAT'S EASIER.

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MR. WADE: AND DO YOU RECALL THIS EMAIL?

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ADAM ROSENDORFF: YES. YES, I DO.

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MR. WADE: AND THIS IS AN EMAIL THAT YOU SENT --

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COURT CLERK: IS IT ON THERE?

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JUROR: OKAY.

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COURT CLERK: YES?

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JUROR: NOW IT'S OKAY.

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BY MR. WADE:

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MR. WADE: OKAY. NOW OUR JURY IS ABLE TO SEE IT. ARE YOU ABLE TO SEE IT, DOCTOR?

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MR. WADE: AND THIS IS AN EMAIL THAT YOU SENT IN PREPARATION FOR THE DECEMBER 2013 INSPECTION; CORRECT?

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MR. WADE: AND YOU SENT THAT TO MS. HOLMES, DR. YOUNG, MR. BALWANI, AND OTHERS; CORRECT?

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MR. WADE: AND YOU SEE IN THAT EMAIL THERE'S A HEADING FOR PROFICIENCY TESTING?

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MR. WADE: AND THIS EMAIL IS ON NOVEMBER 26TH, 2013; CORRECT?

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MR. WADE: OKAY. LET'S GO -- AND YOU INDICATED THAT YOU WERE WORKING WITH DR. YOUNG TO PREPARE AN SOP REGARDING THE PROFICIENCY TESTING PROGRAM --

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MR. WADE: -- FOR THERANOS'S LDT SPECIFICALLY; CORRECT?

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MR. WADE: AND LET'S GO TO EXHIBIT 1580, WHICH IS ALSO IN EVIDENCE. IF WE CAN GO TO PAGES 4 AND 5 AND JUST BLOW UP THE TOP TWO EMAILS. ACTUALLY, YOU KNOW WHAT, DOCTOR, YOU RECALL THERE WAS SOME CONFUSION IN CONNECTION WITH IN THIS EMAIL CHAIN IN YOUR LAST TESTIMONY? DO YOU RECALL THAT?

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MR. WADE: AND IF WE CAN PULL UP EXHIBIT 12478. THAT MIGHT BE EASIER. DO YOU HAVE THAT IN FRONT OF YOU? I'M SORRY, THAT'S NOT IN EVIDENCE YET, ALTHOUGH THE EMAIL CHAIN IS IN EVIDENCE. DO YOU HAVE THAT IN FRONT OF YOU?

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ADAM ROSENDORFF: THE SCREEN IS BLANK RIGHT NOW.

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MR. WADE: IF YOU LOOK IN YOUR BINDER, VOLUME 2, I BELIEVE YOU'LL FIND EXHIBIT 12478. AND WE PUT A POST-IT NOTE ON TOP OF EACH OF YOUR BINDERS, DOCTOR, SO YOU CAN SEE THE NUMERICAL RANGE TO TRY AND MAKE IT EASIER FOR YOU. OKAY?

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ADAM ROSENDORFF: THANK YOU. I HAVE IT.

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MR. WADE: OKAY. DO YOU RECOGNIZE THIS TO BE A SUB EMAIL THAT WAS WITHIN EXHIBIT 1580, PART OF THAT EMAIL CHAIN?

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MR. WADE: OKAY. I MOVE THE ADMISSION OF EXHIBIT 12478.

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MR. BOSTIC: NO OBJECTION.

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JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

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(DEFENDANT'S EXHIBIT 12478 WAS RECEIVED IN EVIDENCE.)

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BY MR. WADE:

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MR. WADE: AND THIS IS THE EMAIL, IF WE LOOK AT THE BOTTOM EMAIL FIRST, THIS IS ON NOVEMBER 26TH, 2013; CORRECT?

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MR. WADE: AND THAT'S THAT SAME DAY OF THAT PAST AGENDA EMAIL REGARDING PREPARATIONS FOR THE INSPECTION; CORRECT?

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MR. WADE: AND IT LOOKS LIKE YOU AND DANIEL IMMEDIATELY WENT TO WORK ON PREPARING THAT SOP; CORRECT?

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ADAM ROSENDORFF: DANIEL IS PROVIDING HIS SUGGESTIONS FOR WHAT THE SOP WOULD LOOK LIKE AND VARIOUS ALTERNATIVES.

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MR. WADE: AND HE'S PROVIDING THEM TO YOU AND COPYING MS. HOLMES AND MR. BALWANI; CORRECT?

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MR. WADE: OKAY. LET'S GO UP THE TOP, TO THE TOP EMAIL. AND THEN THERE THE NEXT DAY, OR MAYBE IT'S THE, MAYBE IT'S THE SAME DAY IF WE HAVE THIS GREENWICH MEAN TIME ISSUE. YOU RESPOND AND SAY, "THANKS, I'LL WRITE UP THE SOP AND INCORPORATE WHAT WE HAVE DISCUSSED." RIGHT?

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MR. WADE: AND YOU INCLUDE MR. BALWANI AND MS. HOLMES ON THAT EMAIL?

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MR. WADE: LET'S GO TO EXHIBIT 9939, WHICH IS NOT YET IN EVIDENCE. IT SHOULD BE IN YOUR BINDER.

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ADAM ROSENDORFF: I HAVE IT.

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MR. WADE: AND DO YOU RECOGNIZE THIS TO BE THE SOP THAT WAS CREATED FOR PROFICIENCY TESTING FOR THERANOS LAB DEVELOPED TESTS ON THE EDISON 3.5?

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MR. WADE: MOVE THE ADMISSION OF EXHIBIT 9939.

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MR. BOSTIC: NO OBJECTION.

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JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

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(DEFENDANT'S EXHIBIT 9939 WAS RECEIVED IN EVIDENCE.)

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BY MR. WADE:

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MR. WADE: IF WE CAN BLOW UP THE TOP HALF. DO YOU SEE IN THE UPPER RIGHT-HAND CORNER THERE IT SAYS THE EFFECTIVE DATE IS NOVEMBER 26TH, 2013?

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MR. WADE: AND THAT WAS THE DATE OF THOSE EMAILS?

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MR. WADE: AND THAT'S YOUR SIGNATURE THERE ON DECEMBER 2ND, 2013?

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ADAM ROSENDORFF: YES. BUT IT'S -- IT APPEARS THAT IT WAS SIGNED SOME TIME AFTER NOVEMBER 22ND -- ON DECEMBER 2ND.

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MR. WADE: IT LOOKS LIKE IT WAS SIGNED WITHIN A WEEK OR SO; CORRECT?

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MR. WADE: AND IN ANY EVENT, WHENEVER IT WAS EFFECTIVE OR WHENEVER IT WAS SIGNED, WITHIN A WEEK YOU HAD FOLLOWED THROUGH ON THAT COMMITMENT THAT YOU HAD MADE TO MS. HOLMES AND MR. BALWANI AND YOU HAD PREPARED THE SOP; CORRECT?

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MR. WADE: LET'S TAKE A LOOK AT THIS SOP. LET'S GO TO THE THIRD PAGE AND BLOW UP THE TOP UNDER THE PURPOSE. AND THIS NOTES, "THE PURPOSE OF THIS PROPOSAL IS TO DEVISE AN ALTERNATIVE ASSESSMENT PROTOCOL (AAP) FOR THE LAB DEVELOPED TESTS ON THE EDISON 3.5 IMMUNOASSAY INSTRUMENT." CORRECT?

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ADAM ROSENDORFF: YOU READ THIS SENTENCE CORRECTLY.

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MR. WADE: AND THAT WAS THE PURPOSE FOR WHICH THIS POLICY WAS PREPARED, CORRECT, SIR?

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MR. WADE: AND UNDER THE SCOPE YOU NOTE THAT THIS APPLIES TO ALL OF THE IMMUNOASSAY THAT ARE TO BE ON THE 3.5; CORRECT?

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MR. WADE: AND YOU REFERENCE AT THE TIME THAT THERE WERE FOUR IMMUNOASSAYS OFFERED; CORRECT?

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MR. WADE: AND YOU NOTE THAT THE AAP SHOULD BE CONDUCTED MINIMALLY EVERY SIX MONTHS; CORRECT?

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MR. WADE: AND LET'S GO DOWN TO THE THIRD SECTION. THIS IS ENTITLED RESPONSIBILITIES?

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MR. WADE: AND IT SAYS, "IT IS THE RESPONSIBILITY OF THE TECHNICAL SUPERVISOR TO ENSURE THAT THE AAP IS CONDUCTED AT LEAST TWICE A YEAR FOR ALL FOUR ANALYTES." CORRECT?

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MR. WADE: AND WHO WAS THE TECHNICAL SUPERVISOR DURING THIS TIME PERIOD, SIR?

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ADAM ROSENDORFF: I BELIEVE IT WAS HODA ALAMDAR.

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MR. WADE: AND I BELIEVE THERE WAS A COUPLE DAYS AGO SOME TESTIMONY THAT MAYBE YOU SERVED IN THIS ROLE DURING THAT TIME PERIOD. DO YOU THINK NOW IT WAS HODA?

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ADAM ROSENDORFF: I WOULD HAVE TO LOOK AT CMS FORM 209 TO VERIFY WHAT THE POSITIONS WERE ON THE ROSTER AT THAT TIME.

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MR. WADE: IN ANY EVENT, WHETHER IT WAS YOU OR HODA, YOU, OF COURSE, HAD THE ULTIMATE RESPONSIBILITY OVER AAP; CORRECT?

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MR. WADE: LET'S GO DOWN TO THE BOTTOM OF THAT SECTION. DO YOU SEE WHERE IT SAYS, "THE LABORATORY TECHNICAL SUPERVISOR IS RESPONSIBLE FOR THE FOLLOWING," AND THEN IT LAYS OUT, "TO MAKE SURE THAT THE SAMPLES ARE IDENTIFIED, AND TO ENSURE THAT OVER A 12 MONTH CYCLE, SAMPLES REPRESENTING THE ENTIRE RANGE," AND THEN WE GO ON TO THE NEXT PAGE, "OF ASSAY ARE SELECTED AND SUBMITTED FOR THE TESTING." DO YOU SEE THAT?

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MR. WADE: AND THAT'S WHERE WE TALKED ABOUT THAT YOU NEEDED TO MAKE SURE THAT YOU HAD TESTS IN THE MIDDLE AND THE UPPER AND LOWER LIMITS TO MAKE SURE THAT THE DEVICE COULD PICK UP ALL OF THOSE RANGES; CORRECT?

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ADAM ROSENDORFF: NO. THE RANGE OF VALUES IN A PROFICIENCY CHALLENGE NEED NOT BE AT THE LLOQ OR ULOQ. THEY SHOULD INCLUDE BOTH NORMAL AND PATHOLOGICAL VALUES.

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MR. WADE: OKAY. AND YOU WERE COMFORTABLE IN THAT APPROACH IN THIS POLICY?

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MR. WADE: LET'S GO TO 3.4. DO YOU SEE THERE IT SAYS, "THE LABORATORY DIRECTOR IS RESPONSIBLE FOR THE FOLLOWING: REVIEWING AND APPROVING EACH PT TESTING EVENTS DOCUMENTATION." DO YOU SEE THAT?

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MR. WADE: AND YOU AGREED WITH THAT AT THE TIME THAT YOU SIGNED THIS DOCUMENT?

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MR. WADE: LET'S GO OVER TO NUMBER 4. THAT SETS FORTH THE PROCEDURES; CORRECT?

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MR. WADE: AND I DON'T WANT TO GO THROUGH EVERY STEP HERE, BUT IS IT FAIR TO SAY THAT YOU WERE TO IDENTIFY FIVE SAMPLES AND COMPARE THE PERFORMANCE OF THOSE FIVE SAMPLES ON THE EDISON AGAINST THE PERFORMANCE OF THOSE FIVE SAMPLES ON A GOLD STANDARD ASSAY?

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MR. WADE: AND IF WE GO TO THE BOTTOM THIS SETS FORTH THE ACCEPTANCE CRITERIA. DO YOU SEE THAT?

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MR. WADE: AND THIS IS THE STANDARD THAT HAS TO BE MET IN ORDER TO PASS THE AAP; CORRECT?

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MR. WADE: AND IF YOU LOOK AT 5.2 IT SAYS OUT OF THOSE FIVE ESSENTIALLY YOU CAN MISS ONE; CORRECT?

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MR. WADE: YOU HAVE TO HIT 80 PERCENT?

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MR. WADE: AND IF YOU LOOK AT 5.4.1, THERE'S DISCUSSION OF HOW TO DEAL WITH FAILURES AND IF THERE ARE FAILURES, YOU NEED TO SIGN OFF ON IT BEFORE ANYTHING ELSE HAPPENS; RIGHT?

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MR. WADE: AND LET'S GO TO THE NEXT PAGE. THIS INCLUDES AGAIN THE REFERENCES OF THE RELEVANT REGULATORY PROVISION WITHIN THE CLIA REGULATIONS; CORRECT?

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MR. WADE: AND THOSE ARE PROVISION THAT ARE SET FORTH IN 7603; RIGHT?

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ADAM ROSENDORFF: WHAT IS 7603, THE EXHIBIT NUMBER?

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MR. WADE: YOU RECALL EXHIBIT 7603 --

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MR. WADE: -- IS THE 120 PAGES OR SO OF CLIA REGULATIONS. DO YOU RECALL THAT?

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MR. WADE: AND THESE REFERENCES ARE AMONG THOSE REGULATIONS; CORRECT?

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MR. WADE: NOW, YOU RECALL THAT YOU WERE ASKED ON YOUR DIRECT TESTIMONY SEVERAL QUESTIONS ABOUT RESULTS THAT WERE SENT TO MS. CHEUNG IN FEBRUARY OF 2014 AFTER COMMERCIAL PT SAMPLES WERE TESTED ON AN EDISON DEVICE?

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ADAM ROSENDORFF: I THINK ERIKA RAN THE EVENT AND SENT OUT THOSE DATA TO OTHERS.

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MR. WADE: RIGHT.

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MR. WADE: AND YOU RECALL THAT YOU WERE ASKED QUESTIONS ABOUT THAT?

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MR. WADE: AND THEY SHOWED YOU THE SPREADSHEET THAT SHE WAS SENDING AROUND; RIGHT?

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MR. WADE: ALL RIGHT. AND THIS EXERCISE WAS NOT DONE PURSUANT TO THE POLICY THAT YOU PUT IN PLACE; CORRECT?

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MR. WADE: AND IT WAS NOT AN APPROPRIATE PROFICIENCY TESTING PROCEDURE; CORRECT?

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ADAM ROSENDORFF: I CAN'T ANSWER THAT YES OR NO.

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MR. WADE: WELL, YOU JUST SAW THE POLICY; CORRECT?

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MR. WADE: AND WAS IT AN APPROPRIATE STEP UNDER THAT AAP POLICY?

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ADAM ROSENDORFF: IT WAS A REASONABLE SPOT QC CHECK. IT WAS NOT FOLLOWING THAT POLICY, NO.

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MR. WADE: RIGHT. SO IT WAS -- IF YOU THINK IT WAS A REASONABLE SPOT QC CHECK. THAT'S YOUR TESTIMONY?

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MR. WADE: I DIDN'T ASK ABOUT THE QC CHECK. I ASKED WHETHER IT WAS AN APPROPRIATE APPLICATION OF THE AAP POLICY THAT YOU PUT IN PLACE AT THE COMPANY?

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ADAM ROSENDORFF: NO, IT DID NOT MATCH.

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MR. WADE: OKAY. AND THAT WAS YOUR POSITION AT THE TIME; RIGHT?

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MR. WADE: AND THAT WAS DR. PANDORI'S POSITION AT THE TIME?

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ADAM ROSENDORFF: YES. I WAS STILL CONCERNED, THOUGH, ABOUT THE DATA THAT I WAS SEEING.

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MR. WADE: AND WE'LL GET -- WE'LL CONTINUE TO GO THROUGH THAT DATA, SIR. OKAY?

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MR. WADE: AND THAT WAS DR. YOUNG'S POSITION AT THE TIME AS WELL THAT IT DIDN'T MATCH THE AAP POLICY?

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ADAM ROSENDORFF: THAT WAS HIS POSITION, YES.

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MR. WADE: AND AS A RESULT OF THAT INCIDENT, THERE WAS CONSIDERABLE CONFUSION ABOUT PROFICIENCY TESTING FOR EDISON DEVICES WITHIN THE COMPANY; CORRECT?

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ADAM ROSENDORFF: THERE SEEMED TO BE A NUMBER OF PEOPLE TAKING VARIOUS POSITIONS. NOT ALL OF THEM WERE AWARE OF THIS ALTERNATIVE ASSESSMENT PROFICIENCY SOP.

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MR. WADE: AND THEY WERE TAKING THOSE POSITIONS WITHOUT UNDERSTANDING THE POLICY AND THAT WAS CREATING SOME CONFUSION; CORRECT?

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MR. WADE: IF YOU COULD TURN YOUR ATTENTION TO 1589, WHICH I BELIEVE IS IN THE GOVERNMENT'S BINDER.

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MR. WADE: OKAY. IT'S IN THE GOVERNMENT'S BINDER, BUT I DON'T BELIEVE THEY PUT IT INTO EVIDENCE. DO YOU RECOGNIZE THIS DOCUMENT TO BE AN EMAIL THAT INVOLVED YOU AND A NUMBER OF OTHERS WITH RESPECT TO CERTAIN QC STEPS FOR THE EDISON?

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ADAM ROSENDORFF: I'M STILL READING THE DOCUMENT BEFORE I CAN RESPOND TO YOU.

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MR. WADE: WELL, JUST FOR PURPOSES OF CLARITY, THIS WAS AN EMAIL CHAIN THAT YOU WERE ON WITH MR. BALWANI AND OTHERS IN THE LAB IN FEBRUARY OF 2014; CORRECT?

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MR. WADE: MOVE THE ADMISSION OF 1589, YOUR HONOR.

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MR. BOSTIC: NO OBJECTION.

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JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

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(GOVERNMENT'S EXHIBIT 1589 WAS RECEIVED IN EVIDENCE.)

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MR. WADE: IF WE CAN GO TO THE BOTTOM.

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MR. WADE: DO YOU RECALL THAT AS A RESULT OF THAT SPOT CHECK, AS YOU DESCRIBED IT FROM MS. CHEUNG AND SOME OF THE CONFUSION, THAT THE LABORATORY LEADERSHIP DECIDED TO DO ADDITIONAL STUDIES?

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ADAM ROSENDORFF: I DON'T, I DON'T RECALL. THAT'S MY UNDERSTANDING FROM READING THE DOCUMENTS TODAY.

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MR. WADE: YOU DON'T RECALL THIS?

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MR. WADE: OKAY. YOU SEE -- ACTUALLY, IF WE CAN GO TO THE LAST EMAIL, MR. BENNETT. THANK YOU. BLOW THAT UP. DO YOU SEE THIS IS AN EMAIL FROM DR. PANDORI TO YOURSELF, MR. GEE, MS. CHEUNG, AND THREE OTHER PEOPLE WHO WORKED IN THE CLIA LAB?

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MR. WADE: AND THIS WAS THE TEAM THAT WAS WORKING ON THE EDISON DEVICES; CORRECT?

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ADAM ROSENDORFF: YES. THIS WAS THE TEAM IN THE CLIA LAB WORKING ON THE EDISONS, YES.

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MR. WADE: RIGHT. THESE WERE -- I THINK THEY WERE ALL WOMEN, THESE WERE THE WOMEN WHO WERE FOR THE MOST PART RUNNING THE TESTS ON THE DEVICES; CORRECT?

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MR. WADE: AND YOU WERE THERE AS WELL?

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MR. WADE: AND MR. GEE WHO IS RESPONSIBLE FOR QUALITY ASSURANCE AND QUALITY CONTROL IS THERE AS WELL?

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MR. WADE: AND LET'S JUST LOOK AT THIS EMAIL. DO YOU SEE THE SECOND IT SAYS, "AS PER OUR DISCUSSION, WE WILL BE APPLYING THE NEW QUALITY MEASURE TO OUR EDISON TESTS." DO YOU SEE THAT?

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MR. WADE: AND YOU DON'T RECALL THIS, IS THAT YOUR TESTIMONY, SIR?

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MR. WADE: AND THEN IT SAYS, "GOING FORWARD, ONCE PER WEEK (WEDNESDAY THE FIRST WEEK, MONDAY THEREAFTER) WE WILL BE COLLECTING AND COMPARING 5 SAMPLES." DO YOU SEE THAT?

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MR. WADE: AND IT SETS FORTH THAT THOSE WILL BE COMPARED WHERE THERE WILL BE A COMPARISON OF VENIPUNCTURE AND FINGERSTICK ASSAYS. DO YOU SEE THAT?

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MR. WADE: OKAY. AND IT SAYS RIGHT UNDER THOSE STEPS, "SUCH COMPARISONS WILL BE PERFORMED INITIALLY USING THESE FOUR TESTS," AND IT SAYS, "VITAMIN D, TPSA, FT4, AND TSH." RIGHT?

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MR. WADE: AND THOSE WERE THE FOUR TESTS THAT WERE RUN ON THE EDISON IN THE LAB AT THAT TIME?

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MR. WADE: AND -- BUT MORE WERE COMING ONLINE AROUND THIS TIME? DO YOU RECALL THAT FROM YESTERDAY OR ON WEDNESDAY?

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ADAM ROSENDORFF: YES, THE PLAN WAS TO INTRODUCE MORE IMMUNOASSAYS THROUGH THE YEAR.

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MR. WADE: AND DO YOU RECALL WHEN WE WENT THROUGH THAT CALENDAR, THERE WERE A FEW THAT CAME ONLINE IN MARCH; RIGHT?

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ADAM ROSENDORFF: I DON'T RECALL MARCH SPECIFICALLY.

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MR. WADE: OKAY. WE'LL COME BACK TO THIS. BUT IT ACTUALLY SAYS IN THE NEXT SENTENCE, WE WILL ADD MORE TESTS TO THIS PROCESS OVER TIME; RIGHT?

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MR. WADE: AND THE INITIAL FOCUS WAS ON THE FOUR BECAUSE THOSE WERE THE FOUR THAT HAD BEEN IN THE LAB FOR THE LONGEST PERIOD OF TIME; RIGHT?

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ADAM ROSENDORFF: I CAN'T ANSWER THAT YES OR NO.

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MR. WADE: OKAY. AND DR. PANDORI -- AND BY THE WAY, DR. PANDORI AT THE TIME WAS THE CO-LAB DIRECTOR?

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MR. WADE: AND HE WAS YOUR NUMBER 2?

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MR. WADE: AND HE HAD THE QUALIFICATIONS FOR BEING A CLIA LAB DIRECTOR FOR A HIGH COMPLEXITY LAB; CORRECT?

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MR. WADE: AND SO THERE WERE TWO DURING THIS PERIOD AT THERANOS?

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MR. WADE: AND HE NOTES HOW HE SUBMITTED THIS IN-HOUSE STUDY FORM AND HE THANKS EVERYONE FOR THEIR WILLINGNESS TO DO THAT. DO YOU SEE THIS?

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MR. WADE: AND THEN LET'S GO TO THE NEXT EMAIL UP THE CHAIN, WHICH IS ON THE FIRST PAGE, BOTTOM EMAIL. DO YOU SEE THAT? THAT'S AN EMAIL FROM MR. BALWANI?

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MR. WADE: TO A GROUP OF PEOPLE?

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MR. WADE: AND HIGH IMPORTANCE. DO YOU SEE THAT?

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MR. WADE: AND HE TALKS ABOUT HOW THIS STUDY IS GOING TO BE DONE A LITTLE BIT. AND THEN AT THE BOTTOM OF THAT PARAGRAPH HE SAYS, "SO THIS NEEDS TO BE PERFECTLY PLANNED AND PERFECTLY EXECUTED." DO YOU SEE THAT?

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MR. WADE: DO YOU SEE THAT?

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ADAM ROSENDORFF: YEAH, YEAH.

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MR. WADE: "IF THE CLIA TEAM NEEDS HELP PULLING THE RIGHT DATA THEN PLEASE INCLUDE THE APPROPRIATE TEAM MEMBERS." DO YOU SEE THAT?

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MR. WADE: AND "ALSO, I WOULD LIKE TO SEE A PROJECT EXECUTION PLAN THAT CLIA SHOULD GENERATE." DO YOU SEE THAT?

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MR. WADE: "(LANGLY TO OWN)"?

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MR. WADE: AND THAT'S MR. GEE?

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MR. WADE: AND HE'S RESPONSIBLE FOR QUALITY ASSURANCE?

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MR. WADE: AND MR. BALWANI IS DIRECTING THAT YOU BE THE ONE WHO OWNS THIS PROGRAM; CORRECT?

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MR. WADE: AND THEN HE SAYS, "AND THEN SHARADA, SURAJ, AND DANIEL WILL REVIEW AND SIGN OFF BEFORE WE BEGIN THIS." DO YOU SEE THAT?

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MR. WADE: AND IF YOU GO BACK TO THE HEADER IN THAT EMAIL, YOU SEE THAT MR. BALWANI ADDED IN TO THIS EMAIL CHAIN DANIEL YOUNG, DR. YOUNG, DR. SIVARAMAN, DR. SAKSENA, AND TINA LIN. DO YOU SEE THAT?

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MR. WADE: AND THOSE WERE PEOPLE WHO HAD A LOT OF EXPERIENCE WITH THE RESEARCH AND DEVELOPMENT OF THOSE ASSAYS; RIGHT?

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ADAM ROSENDORFF: DANIEL AND SHARADA FOR SURE. SURAJ AND TINA I'M NOT SURE.

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MR. WADE: BUT HE'S BRINGING THEM IN TO GET MORE EXPERTISE ON THIS PROJECT; RIGHT?

280

MR. WADE: AND LET'S GO UP THE CHAIN TO THE NEXT EMAIL. AND YOU PROVIDE SOME CLARIFICATION ON WHETHER THE TECHNICAL ISSUES RELATING TO WHICH BLOOD TO USE. DO YOU SEE THAT?

282

MR. WADE: AND THEN IN THE BOTTOM YOU SAY YOU WILL WORK WITH LANGLY BEFORE WE SUBMIT THE PLAN TO DANIEL AND YOURSELF FOR REVIEW. YOU'RE ENDORSING THIS APPROACH; RIGHT?

284

MR. WADE: AND LET'S GO UP TO THE NEXT EMAIL.

285

ADAM ROSENDORFF: I'M ACTUALLY THE ONE THAT WILL HAVE TO SIGN OFF ON THE PLAN.

286

MR. WADE: IT COULDN'T HAPPEN WITHOUT YOU IN THE CLIA LAB, RIGHT, SIR?

287

ADAM ROSENDORFF: I WOULD HAVE TO APPROVE THE PLAN.

288

MR. WADE: RIGHT. AND YOU'RE SAYING THAT YOU'RE GOING TO REVIEW IT AND THEN YOU'LL RUN IT BY THEM, TOO; RIGHT?

290

MR. WADE: AND BECAUSE THEY'RE HIGHER IN THE HIERARCHY THAN YOU?

292

MR. WADE: AND SO THAT'S NOT UNUSUAL, RIGHT, TO RUN SOMETHING BY YOUR --

295

ADAM ROSENDORFF: I ALSO WANTED TO GET THEIR BUY IN TO MAKE SURE WE GET DONE.

296

MR. WADE: OKAY. AND YOU SEE IN THE NEXT EMAIL ABOVE MR. BALWANI RESPONDS AND THEN ON THE SECOND LINE THERE HE SAYS, "IF YOU WANT TO RERUN THIS ONCE TO GENERATE QC DATA, I HAVE NO ISSUES WITH THE FOLLOWING AS COMMUNICATED YESTERDAY." DO YOU SEE HIS DISCUSSION THERE?

298

MR. WADE: AND HE SAYS HE WANTS IT TO BE USEFUL TO CLARIFY ANY CONFUSION CAUSED BY THE PT SAMPLES; RIGHT?

300

MR. WADE: AND THAT'S THE ERIKA CHEUNG SAMPLES; RIGHT?

302

MR. WADE: AND THEN THE NEXT SENTENCE HE SAYS, "WE CAN DECIDE HOW OFTEN WE NEED TO DO THIS." DO YOU SEE THIS?

304

MR. WADE: AND THEN HE SAYS, "THIS IS SOMETHING THAT YOU AND MARK CAN DECIDE AND THEN LANGLY CAN IMPLEMENT." DO YOU SEE THAT?

306

MR. WADE: AND I'LL CALL YOUR ATTENTION TO 3526.

307

ADAM ROSENDORFF: WHERE IS THAT?

308

MR. WADE: 3526. THERE'S A POST-IN NOTE ON TOP OF THE BINDER THAT SHOULD TELL YOU WHICH BINDER. I APOLOGIZE, BUT I'M NOT WORKING OFF THE SAME BINDER AS YOU. I'LL TELL YOU WHAT, I'M SORRY TO JUMP AROUND, DOCTOR, BUT LET'S GO TO 12582 FIRST, AND THEN WE'LL COME BACK TO THAT EMAIL THAT I JUST MENTIONED.

310

MR. WADE: AND DO YOU SEE THIS IS AN EMAIL BETWEEN A GROUP OF PEOPLE WITHIN THE CLIA LAB RELATING TO VITAMIN D RESULTS IN MARCH OF 2014?

312

MR. WADE: MOVE THE ADMISSION OF 12582.

313

MR. BOSTIC: NO OBJECTION.

314

MR. WADE: LET'S GO TO THE BACK OF THE EMAIL.

315

JUDGE DAVILA: IT MAY BE PUBLISHED.

316

(DEFENDANT'S EXHIBIT 12582 WAS RECEIVED IN EVIDENCE.)

317

MR. WADE: THANK YOU, YOUR HONOR.

318

MR. WADE: IF WE CAN BLOW UP THE BOTTOM EMAIL. NOW, THIS IS MR. GEE SENDING AN EMAIL TO THE PEOPLE -- THE WOMEN WITHIN THE LAB WHO ARE RUNNING THOSE EDISON DEVICES; RIGHT?

320

MR. WADE: AND COPYING YOU AND DR. PANDORI?

322

MR. WADE: AND HE'S ASKING FOR THE RAW DATA FROM THE VITAMIN D RESULTS; CORRECT?

324

MR. WADE: AND THAT'S FROM THIS, THIS STUDY THAT WAS UNDERWAY THAT WE WERE JUST LOOKING AT; RIGHT?

325

ADAM ROSENDORFF: I DON'T KNOW IF IT WAS UNDERWAY OR NOT. I SAW THE PROPOSAL.

326

MR. WADE: WELL, LET'S TAKE A LOOK. LET'S GO UP TO THE NEXT CHAIN. IT STRADDLES THE PAGE. BUT DO YOU SEE IT'S AN EMAIL FROM ERIKA CHEUNG, IF YOU LOOK AT THE BOTTOM OF THE FIRST PAGE, AND THEN WHAT IS ON THE SCREEN IS WE'LL JUST LOOK QUICKLY AT THE BOTTOM OF THE FIRST PAGE. I WANT TO MAKE SURE THAT YOU UNDERSTAND THE TIMING OF THIS.

328

MR. WADE: OKAY. DO YOU SEE THERE THIS IS AN EMAIL FROM ERIKA CHEUNG AND IT RESPONDS TO THE EMAIL FROM MR. GEE? DO YOU SEE THAT?

330

MR. WADE: AND THEN IF WE GO TO THE NEXT PAGE, THIS IS MS. CHEUNG PROVIDING THAT DATA IN CONNECTION WITH THAT VITAMIN D STUDY. DO YOU SEE THAT?

332

MR. WADE: AND THAT'S IN MARCH 10TH OF 2014. DO YOU SEE THAT?

333

ADAM ROSENDORFF: YEAH. SO THIS IS A TABLE WHERE THEY HAVE RUN FIVE SAMPLES ON THE DIASORIN INSTRUMENT, WHICH WE WERE USING, IT WAS AN FDA APPROVED INSTRUMENT THAT WE WERE USING TO MEASURE 25 HYDROXY, VITAMIN D. GO AHEAD.

334

MR. WADE: AND THAT IS THE GOLD STANDARD IN THIS STUDY; CORRECT?

336

MR. WADE: AND WHAT MS. CHEUNG IS DOING IS SHE'S SAYING HERE'S A TABLE WHERE YOU CAN FILL IN THE INFORMATION FOR THE EDISON DEVICES; CORRECT?

337

ADAM ROSENDORFF: THAT'S CORRECT.

338

MR. WADE: LET'S GO TO THE NEXT PAGE. AND DR. PANDORI HERE SAYS HE'S NOT SURE IF IT MATTERS, BUT HE SAYS LET'S DO THIS BLIND TO THE PREDICATE RESULTS, MEANING LET'S NOT LET PEOPLE KNOW WHICH SIDE OF THE TEST THAT THEY HAVE; RIGHT? HE WANTS THIS TO BE PURE AND ANONYMOUS; RIGHT?

339

ADAM ROSENDORFF: I'M NOT SURE WHAT HE MEANS BY BLIND BECAUSE THE TECH WOULD BE STANDING IN FRONT OF AN EDISON PROCESSING THE SAMPLE SO THEY COULDN'T BE BLIND TO THE METHOD BEING DEPLOYED. I THINK HE'S ALSO SAYING THAT HE WANTS THE EDISON GROUP TO DO THIS AND NOT R&D.

340

MR. WADE: OKAY. AND DO YOU THINK THAT'S A GOOD IDEA?

342

MR. WADE: OKAY. LET'S -- AND IF YOU GO UP TO THE TOP EMAIL, YOU'LL SEE DR. GEE AGREES WITH YOU OR AGREES WITH DR. PANDORI; CORRECT?

344

MR. WADE: AND YOU'RE ON THESE EMAILS?

346

MR. WADE: OKAY. LET'S GO TO, LET'S NOW GO TO 35 -- SO THIS IS MARCH 10TH, 2014. DO YOU SEE THAT?

348

MR. WADE: ALL RIGHT. LET'S GO TO 3526. I BELIEVE THAT'S IN THE -- IT'S NOT IN EVIDENCE. I BELIEVE IT'S IN THE OTHER BINDER MAYBE THAT YOU JUST PUT DOWN.

350

MR. WADE: DO YOU HAVE THAT IN FRONT OF YOU?

352

MR. WADE: OKAY. AND THAT'S AN EMAIL BETWEEN A GROUP OF PEOPLE WITHIN THE CLIA LAB WITH THE SUBJECT MATTER INTERNAL VITAMIN D PT. DO YOU SEE THAT?

354

MR. WADE: MOVE THE ADMISSION OF 3526.

355

MR. BOSTIC: HEARSAY, YOUR HONOR.

356

(PAUSE IN PROCEEDINGS.)

357

MR. WADE: YOUR HONOR, I NOTE THIS IS AN EXHIBIT IDENTIFIED BY THE GOVERNMENT, NUMBER ONE; AND, NUMBER TWO, THIS IS PART OF THIS ONGOING PROCESS THAT IS HAPPENING WITHIN THE CLIA LAB. THE WITNESS HAS ALREADY --

358

JUDGE DAVILA: IS THIS OFFERED FOR THE TRUTH OF THE -- WHAT IS SAID IN THE EMAIL ITSELF?

359

MR. WADE: I BELIEVE I CAN LAY THE FOUNDATION FOR THIS. THIS IS A BUSINESS RECORD THAT IS BEING APPLIED. IF THE COURT REQUIRES ME TO DO THAT. BUT IN ANY EVENT, IT WOULD BE OFFERED FOR THE STATE OF MIND OF MS. HOLMES.

360

JUDGE DAVILA: AS TO WHAT ISSUE?

361

MR. WADE: AS TO THE INTERNAL -- THE PERFORMANCE OF THE INTERNAL PROFICIENCY TESTING AT THIS PERIOD IN MARCH OF 2014.

362

JUDGE DAVILA: YOU'RE OFFERING IT FOR THAT PURPOSE ONLY?

363

MR. WADE: I -- WHY DON'T I LAY THE FOUNDATION, AND I WILL OFFER IT FOR THAT PURPOSE. ALTERNATIVELY IF, IF THE COURT DOESN'T --

364

JUDGE DAVILA: WELL, THAT'S MY QUESTION.

365

MR. WADE: LET ME LAY --

366

MR. WADE: THIS WAS AN EMAIL THAT WAS COMMUNICATED IN CONNECTION WITH THAT STUDY THAT WE WERE JUST TALKING ABOUT; CORRECT?

367

ADAM ROSENDORFF: IT APPEARS TO BE.

368

MR. WADE: YEAH. AND THE EMAIL -- THERE WAS A LOT OF EMAIL COMMUNICATIONS IN THIS TIME PERIOD THAT WE JUST LOOKED AT. DO YOU RECALL SEEING THOSE?

370

MR. WADE: AND THOSE EMAIL COMMUNICATIONS WERE THE WAY IN WHICH THE LAB WAS COMMUNICATING ABOUT HOW TO EXECUTE ON THIS STUDY WITHIN THE CLIA LAB; CORRECT?

372

MR. WADE: AND IT WAS THE WAY IN WHICH MEMBERS OF THE TEAM WERE ON A REGULAR BASIS SHOWING INFORMATION, SHARING INFORMATION ABOUT WHAT WAS HAPPENING; CORRECT?

373

ADAM ROSENDORFF: YES. BUT IT LOOKS LIKE SURAJ WENT TO SUNNY AND SHOWED HIM SOMETHING ON PAPER. SURAJ CAME BY AND SHARED DATA, ET CETERA. SO WHAT I'M SAYING IS THAT THE EMAIL OBVIOUSLY WASN'T THE EXCLUSIVE. THERE WERE FOLKS SHOWING EACH OTHER DATA ON PAPER AND WHATNOT.

374

MR. WADE: RIGHT. AND IN ADDITION TO THE EMAIL PRACTICES OF SHARING INFORMATION, SOMETIMES THERE WOULD BE MEETINGS WITHIN THE CLIA LAB; CORRECT?

376

MR. WADE: AND WITH THE LEADERSHIP OF THE CLIA LAB; CORRECT?

377

ADAM ROSENDORFF: THIS EMAIL IS ABOUT SURAJ COMING TO SUNNY AND SHOWING HIM DATA FOR VITAMIN D.

378

MR. WADE: OKAY. AND WHEN YOU -- WHEN THE LAB WAS COMMUNICATING ABOUT THESE RESULTS AND SHARING SHOWS RESULTS WITH MANAGEMENT, WAS IT IMPORTANT THAT THE INFORMATION BE ACCURATE?

379

ADAM ROSENDORFF: SURAJ IS NOT PART OF THE LAB.

380

MR. WADE: OKAY. WHY DON'T I JUST OFFER IT FOR OUR CLIENT'S STATE OF MIND SINCE IT APPEARS --

381

JUDGE DAVILA: LADIES AND GENTLEMEN, THIS EXHIBIT AND THE CONTENTS OF IT WILL BE ADMITTED NOT FOR THE TRUTH OF THE MATTER ASSERTED IN THE EMAIL ITSELF. IT IS ADMITTED ONLY FOR THE PURPOSE OF ESTABLISHING MS. HOLMES'S STATE OF MIND AS TO THE ISSUE INFORMED. IT'S NOT OFFERED FOR THE TRUTH OF WHAT IS STATED, ONLY AS TO MS. HOLMES'S STATE OF MIND ON THIS ISSUE.

382

MR. WADE: MAY I PUBLISH, YOUR HONOR?

383

JUDGE DAVILA: IT MAY BE ADMITTED FOR THAT PURPOSE.

384

MR. WADE: THANK YOU, YOUR HONOR. MAY I PUBLISH?

386

(GOVERNMENT'S EXHIBIT 3526 WAS RECEIVED IN EVIDENCE.)

387

BY MR. WADE:

388

MR. WADE: NOW, THIS EMAIL COMES A COUPLE OF WEEKS AFTER THE EMAIL CHAIN WITH MR. PANDORI ABOUT THE STUDY THAT WAS GOING TO BE DONE?

389

ADAM ROSENDORFF: I'M SORRY, I DON'T REMEMBER THE DATE OF DR. PANDORI'S EMAIL. I ASSUME THAT'S CORRECT, YEAH.

390

MR. WADE: AND IT WAS ACTUALLY FEBRUARY 24TH, 2014?

392

MR. WADE: AND ON MARCH -- ONE OF THE TESTS BEING DONE ON THAT STUDY WAS VITAMIN D; CORRECT?

394

MR. WADE: AND THERE WAS PARTICULAR FOCUS ON THAT BECAUSE THAT WAS THE DATA THAT MS. CHEUNG HAD SHARED; CORRECT?

396

MR. WADE: OKAY. AND YOU SEE THIS EMAIL HAS THE SUBJECT MATTER INTERNAL VITAMIN D PT. DO YOU SEE THAT?

398

MR. WADE: AND PT THERE IS BEING REFERRED TO AS PROFICIENCY TESTING; CORRECT?

400

MR. WADE: AND THEN THIS SAYS, "SURAJ CAME BY AND SHARED THE INITIAL DATA FOR PT FOR OUR VITAMIN D LOOKS GOOD." DO YOU SEE THAT?

402

MR. WADE: AND WE JUST SAW IN THE EMAILS THAT MS. CHEUNG AND THE OTHERS WHO WERE WORKING IN THE CLIA LAB ON THE EDISONS WERE GATHERING VITAMIN D DATA; CORRECT?

404

MR. WADE: OKAY. AND IT SAYS, "IT LOOKS GOOD" HERE; RIGHT?

405

ADAM ROSENDORFF: ARE YOU ASKING ME TO READ "IT LOOKS GOOD"?

406

MR. WADE: WELL, YOU SEE WHAT IT SAYS HERE?

407

ADAM ROSENDORFF: YEAH. THAT'S MR. BALWANI'S ASSERTION.

408

MR. WADE: UNDERSTOOD. AND THAT'S SENT TO YOU; RIGHT?

410

MR. WADE: AND DO YOU HAVE ANY REASON TO QUESTION THAT ASSERTION AS YOU SIT HERE TODAY?

412

MR. WADE: YOU DO?

414

MR. WADE: OKAY. YOU THINK THAT DATA WAS NOT ACCURATE?

415

ADAM ROSENDORFF: I DON'T BELIEVE MR. BALWANI IS QUALIFIED TO REVIEW THE DATA AS FOR IT'S LOOKING GOOD, QUOTE UNQUOTE, OR NOT.

417

ADAM ROSENDORFF: I THINK SURAJ IS SHOWING IT TO HIM. HE'S PART OF THE R&D AND NOT PART OF THE CLIA LAB. THAT IS CONCERNING TO ME.

418

MR. WADE: THAT'S CONCERNING TO YOU?

420

MR. WADE: AND YOU'RE COPIED ON THIS EMAIL. DO YOU SEE THAT?

422

MR. WADE: AND IT'S UP AT THE TOP. DO YOU SEE THAT?

424

MR. WADE: AND SURAJ IS SAYING THAT THIS DATA OR YOUR BOSS IS MR. BALWANI; CORRECT?

426

MR. WADE: AND HE'S SAYING THAT HE SAW DATA THAT LOOKED GOOD?

428

MR. WADE: AND DID YOU GO AND GET THE DATA?

430

MR. WADE: AND YOU DIDN'T GO AND GET THE DATA?

433

ADAM ROSENDORFF: IT WAS NOT PRESENTED TO ME.

434

MR. WADE: OKAY. DID YOU GO AND ASK FOR IT?

436

MR. WADE: OKAY. MR. BALWANI THEN SAYS, "THIS IS NOT A BIT SURPRISING TO ME NOW THAT WE ARE COMPARING APPLES TO APPLES." DO YOU SEE THAT?

438

MR. WADE: THAT YOU'RE COMPARING OR FOLLOWING A PROCEDURE THAT IS SIMILAR TO THAT AAP WHERE YOU'RE COMPARING THE EDISON DEVICE AGAINST THE GOLD STANDARD; CORRECT?

440

MR. WADE: AND HE ASKED YOU TO KEEP HIM IN THE LOOP ON THAT; CORRECT?

442

MR. WADE: OKAY. AND DR. PANDORI IS ON THE TO LINE?

444

MR. WADE: AND YOU'RE ON THE TO LINE?

446

MR. WADE: AND MR. GEE IS ON THE TO LINE?

448

MR. WADE: AND DANIEL YOUNG IS ON THE TO LINE?

450

MR. WADE: AND MR. BALWANI IS THE BOSS --

451

JUDGE DAVILA: IS THAT YES?

453

BY MR. WADE:

454

MR. WADE: -- OF THOSE PEOPLE; CORRECT?

456

MR. WADE: AND HE WANTS YOU TO KEEP HIM POSTED; CORRECT?

457

ADAM ROSENDORFF: I'M NOT SURE WHO HE WAS REFERRING TO WHEN HE SAYS PLEASE KEEP ME IN THE LOOP IN REALTIME. I'M ASSUMING HE'S ADDRESSING THE GROUP, THE WHOLE GROUP THAT IS IN THE TO LINE.

458

MR. WADE: OKAY. AND I JUST WANT TO MAKE SURE THAT I UNDERSTAND YOUR TESTIMONY. IS IT YOUR TESTIMONY THAT YOU DIDN'T LOOK AT VITAMIN D THAT WAS COMING BACK FROM THE EDISON TEAM IN CONNECTION WITH THIS PROJECT?

459

ADAM ROSENDORFF: IT WAS NEVER PRESENTED TO ME.

460

MR. WADE: LET'S GO TO 13750.

461

ADAM ROSENDORFF: OKAY. I HAVE IT.

462

MR. WADE: DO YOU SEE THIS IS AN EMAIL FROM MR. GEE TO YOU AND DR. PANDORI AND A COUPLE OF YOUR COLLEAGUES ON MARCH 14TH, 2014?

464

MR. WADE: MOVE THE ADMISSION OF 13750.

465

MR. BOSTIC: NO OBJECTION. IT MAY BE PUBLISHED.

466

(DEFENDANT'S EXHIBIT 13750 WAS RECEIVED IN EVIDENCE.)

467

BY MR. WADE:

468

MR. WADE: LET'S LOOK AT THE EMAIL. DO YOU SEE THIS SAYS, "ATTACHED ARE YESTERDAY'S MINUTES"?

470

MR. WADE: OKAY. AND YOU HAD REGULAR MEETINGS WITHIN THE CLIA LAB WITH YOUR TEAM; CORRECT?

472

MR. WADE: AND THAT WOULD INCLUDE SOME OF THE KEY LEADERSHIP, IF YOU WILL, WITHIN THE CLIA LAB, THE CORE PEOPLE?

473

ADAM ROSENDORFF: THE MEETINGS WERE WITH THE WHOLE CLIA LAB.

474

MR. WADE: OKAY. AND THE FOUR PEOPLE WHO ARE INCLUDED HERE, DO YOU RECALL MS. CHIANG?

475

ADAM ROSENDORFF: YES, I REMEMBER HER, BUT I DON'T REMEMBER WHAT HER ROLE WAS SPECIFICALLY.

476

MR. WADE: WAS SHE THE GENERAL SUPERVISOR AT THIS TIME?

477

ADAM ROSENDORFF: I DO NOT RECALL.

478

MR. WADE: ALL RIGHT. AND THIS ATTACHES MINUTES; CORRECT?

479

ADAM ROSENDORFF: YES, I BELIEVE SO.

480

MR. WADE: LET'S GO TO THE MINUTES. THE DATE IS MARCH 13TH, 2014. DO YOU SEE THAT?

482

MR. WADE: IF WE CAN BLOW UP ITEM 2. DO YOU SEE THERE IT SAYS THAT THERE WAS DISCUSSION OF AAP FOR ALL SEVEN EDISON ASSAYS?

484

MR. WADE: AND DO YOU HAVE ANY REASON TO QUESTION THE ACCURACY OF THESE MINUTES?

485

ADAM ROSENDORFF: NO. I DO NOT HAVE A CLEAR RECOLLECTION OF WHAT WAS DISCUSSED AT THAT MEETING. I DON'T HAVE ANY REASON TO DOUBT THE ACCURACY OF THE MINUTES.

486

MR. WADE: AND JUST SO WE'RE CLEAR, ISN'T THAT EXACTLY -- YOU WOULD HAVE EXPECTED MR. GEE AS THE PERSON TASKED WITH THE AAP TO PERFORM THAT; CORRECT?

488

MR. WADE: LET'S GO TO 3477. LET ME KNOW WHEN YOU HAVE THAT IN FRONT OF YOU, DOCTOR.

490

MR. WADE: AND THIS IS AN EMAIL BETWEEN A GROUP OF PEOPLE WITHIN THE CLIA LAB, INCLUDING YOURSELF, DR. PANDORI, MS. ALAMDAR, AND A COUPLE FROM OUTSIDE OF THE CLIA LAB?

492

MR. WADE: THIS IS IN MARCH 20TH, 2014. DO YOU SEE THAT?

494

MR. WADE: MOVE FOR THE ADMISSION OF 3477.

495

MR. BOSTIC: NO OBJECTION.

496

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

497

(GOVERNMENT'S EXHIBIT 3477 WAS RECEIVED IN EVIDENCE.)

498

BY MR. WADE:

499

MR. WADE: IF WE CAN START AT THE BACK. IF WE CAN BLOW UP THE BOTTOM EMAIL. OKAY. THIS IS MARCH 18TH; CORRECT?

501

MR. WADE: AND THAT'S FOUR DAYS AFTER THE EMAIL FROM MR. BALWANI ABOUT THE INTERNAL VITAMIN D PT; CORRECT?

503

MR. WADE: AND MR. GEE SAYS, "SEE ATTACHED FOR WEEK 2 VITAMIN D RESULTS." DO YOU SEE THAT?

505

MR. WADE: AND DO YOU SEE YOUR NAME THERE?

507

MR. WADE: AND YOU RECEIVED THAT EMAIL?

509

MR. WADE: OKAY. LET'S GO UP TO MR. BALWANI'S RESPONSE. NO. I'M SORRY. IF WE CAN BLOW UP THE EMAIL RIGHT ABOVE MR. GEE. WE'RE GOING TO GO RIGHT UP THIS CHAIN. OKAY. DO YOU SEE MR. BALWANI RECEIVED THAT, RECEIVED THOSE RESULTS AS WELL?

511

MR. WADE: AND I JUST WANT TO MAKE SURE, THERE'S BEEN SOME TESTIMONY ABOUT WHETHER IT'S APPROPRIATE FOR MR. BALWANI TO RECEIVE INFORMATION. DO YOU HAVE ANY ISSUE WITH HIM BEING COPIED ON ANY OF THIS INFORMATION?

512

ADAM ROSENDORFF: IN GENERAL, I DON'T THINK MR. BALWANI WAS QUALIFIED TO BE DIRECTING A QC STUDY. IT WAS NOT APPROPRIATE FOR HIM TO BE DIRECTING CLIA STAFF OR MAKING ANY KIND OF DECISIONS TO THE VALIDITY OF DATA.

513

MR. WADE: OKAY. BUT SHARING INFORMATION WITH HIM, WOULD THAT HAVE BEEN OKAY?

514

ADAM ROSENDORFF: IF HE HAD REQUESTED IT THEN YES.

515

MR. WADE: OKAY. WELL, LET'S TAKE A LOOK AT THIS EMAIL. DO YOU SEE THERE HE WILL SAY -- HE SAYS, "FOR THE NEXT RUN, I WOULD LIKE TO NARROW DOWN WHY 1 SAMPLE IS OFF IN THIS 5 RUNS?" DO YOU SEE THAT?

517

MR. WADE: THAT MEANS ONLY FOUR OUT OF FIVE PASSED; CORRECT?

518

ADAM ROSENDORFF: THAT'S WHAT THE INFERENCE -- YEAH, THAT'S THE INFERENCE, YEAH.

519

MR. WADE: OKAY. AND JUST SO WE'RE CLEAR, FOUR OUT OF FIVE WOULD HAVE BEEN PASSING UNDER THE AAP POLICY; RIGHT?

521

MR. WADE: AND THAT'S 80 PERCENT?

523

MR. WADE: AND SO YOU WOULD BE ABLE TO MOVE FORWARD WITH THE VITAMIN D TEST; CORRECT?

525

MR. WADE: BUT HE'S SAY -- HE WANTS TO KNOW MORE ABOUT WHY THE ONE FAILED. DO YOU SEE THAT?

526

ADAM ROSENDORFF: SO I DON'T KNOW IF THIS STUDY WAS RUN FAITHFULLY TO THE AAP SOP BECAUSE THAT SOP SPECIFIES THAT YOU ALSO NEED PATHOLOGICAL SPECIMENS, RIGHT.

527

MR. WADE: YOU'RE AWARE THAT THIS STUDY WAS HAPPENING WITHIN THE CLIA LAB AT THE TIME; CORRECT?

528

ADAM ROSENDORFF: I DON'T RECALL THE STUDY. I'M JUST READING IT HERE WITH YOU TODAY.

529

MR. WADE: OKAY. AND YOU SEE HERE THAT HE SAYS HE WANTS TO UNDERSTAND WHY ONE OF THE FIVE RUNS DIDN'T PASS. DO YOU SEE THAT?

531

MR. WADE: AND DO YOU SEE THAT HE SAYS -- AND AGAIN, THIS IS ON VITAMIN D, WHICH IS THE ISSUE THAT MS. CHEUNG RAISED; RIGHT?

532

ADAM ROSENDORFF: MS. CHEUNG'S EMAIL THERE WERE A NUMBER OF ANALYTES THAT WERE -- I BELIEVE IN THE QC SPOT-CHECK THERE WERE A NUMBER OF ANALYTES THAT WERE LOOKED AT.

533

MR. WADE: BUT IN THIS PERIOD THE PARTICULAR FOCUS WAS VITAMIN D; RIGHT?

534

ADAM ROSENDORFF: I CAN'T ANSWER THAT YES OR NO.

535

MR. WADE: YOU DON'T REMEMBER. OKAY. HE SAYS HERE LET'S INCREASE THE NUMBER OF SAMPLES FROM 5 TO 10 OR 20 SO WE RUN MORE TESTS. DO YOU SEE THAT?

537

MR. WADE: AND THAT WOULD BE DOUBLE OR 400 PERCENT OR SOMETHING MORE THAN WHAT WAS REQUIRED UNDER AAP; RIGHT?

539

MR. WADE: AND THEN IF YOU GO UP TO THE NEXT EMAIL MR. GEE SAYS HE WILL MODIFY THE STUDY PLAN TO ACCOMMODATE YOUR SUGGESTIONS. DO YOU SEE THAT?

541

MR. WADE: AND THAT'S NOT APPROPRIATE, IS IT?

543

MR. WADE: YOU SHOULD BE THE ONE WHO IS CONSULTED ON THAT; CORRECT?

545

MR. WADE: AND/OR DR. PANDORI; CORRECT?

547

MR. WADE: ALL RIGHT. LET'S GO TO THE NEXT EMAIL. NOW HERE MR. BALWANI SAYS, ONLY IF THEY MAKE SENSE. YOU GUYS DECIDE BUT SEEMS LIKE MORE DATA WILL BE USEFUL; RIGHT?

549

MR. WADE: THAT'S EXACTLY WHAT YOU WOULD HAVE EXPECTED; CORRECT?

551

MR. WADE: HE LET YOU DECIDE?

553

MR. WADE: LET'S GO UP ONE MORE EMAIL. DR. PANDORI SAYS, "I DO LIKE THE IDEA OF RUNNING MULTIPLE DEVICES." DO YOU SEE THAT?

555

MR. WADE: AND TO GET MORE RESULTS; RIGHT?

556

ADAM ROSENDORFF: SO THE IDEA OF RUNNING MULTIPLE DEVICES WOULD BE TO MAKE SURE YOU GET THE SAME RESULT ON TWO DIFFERENT DEVICES.

557

MR. WADE: THAT THERE'S NOT VARIABILITY WITHIN THE RESULTS; CORRECT?

558

ADAM ROSENDORFF: FROM DEVICE TO DEVICE, RIGHT.

559

MR. WADE: RIGHT. AND HE SAYS THAT. BUT HE SAYS, "INCREASING THE SAMPLE SIZE TO 10 OR 20 AND RUNNING ON TWO DEVICES IS MORE DIFFICULT THAN IT SEEMS, FOR THE REASON THAT WE PLAN TO ADD TSH AND FT4 TO THIS STUDY NEXT MONDAY." DO YOU SEE THAT?

561

MR. WADE: AND SO HE'S SAYING WE'RE TESTING VITAMIN D, WE'RE GOING ON TO DO THE SAME TESTING ON TWO MORE ASSAYS; RIGHT?

563

MR. WADE: AND THAT WAS GOING TO START ON MONDAY; RIGHT?

565

MR. WADE: AND SO IF, IF YOU DO THAT, THAT WOULD MEAN THAT EITHER HE SAYS THERE ARE 60 OR 120 RUNS ON THE EDISONS. DO YOU SEE THAT?

567

MR. WADE: AND, AND DR. PANDORI SAYS THIS WOULD COMPLETELY OCCUPY THE EDISONS FOR ONE OR TWO DAYS; RIGHT?

569

MR. WADE: AND HE SAYS HE'S CONCERNED THAT THAT MIGHT INHIBIT PATIENT TURNAROUND TIMES; RIGHT?

571

MR. WADE: AND SO HE'S ACTUALLY SAYING THAT WHAT MR. BALWANI IS PROPOSING IS EXCESSIVE?

572

ADAM ROSENDORFF: YEAH. I MEAN, I THINK MR. BALWANI WAS PROPOSING FOR VITAMIN D AND SAYING WE SHOULD EXTEND THIS TO THE OTHER EDISON ANALYTES, WHICH IS APPROPRIATE. HE'S ALSO JUST SAYING ON A PRACTICAL LEVEL THAT SAMPLE SIZE FOR ALL OF THE ANALYTES RUNNING ON TWO DEVICES IS GOING TO PREVENT THE REGULAR CLINICAL SAMPLES FROM BEING, YOU KNOW, TESTED AND WILL IMPACT TURNAROUND TIMES.

573

MR. WADE: RIGHT. AND DR. PANDORI IS APPROPRIATELY WORRIED ABOUT MAKING SURE THAT THE PATIENT TURNAROUND TIMES --

575

MR. WADE: -- ARE ON SCHEDULE; RIGHT?

577

MR. WADE: AND SO HE SAYS GOOD IDEA, BUT IT'S JUST TOO MUCH; RIGHT?

578

ADAM ROSENDORFF: ESSENTIALLY.

579

MR. WADE: OKAY. LET'S LOOK UP THE CHAIN. MR. BALWANI AGREES WITH DR. PANDORI; RIGHT?

581

MR. WADE: AND HE SAYS, "LET'S JUST DO THIS FOR VITAMIN D THIS WAY AND OTHERS THE WAY ALREADY PLANNED." DO YOU SEE THAT?

583

MR. WADE: AND SO WE'RE GOING TO BE DOING THESE OTHER TESTS, BUT LET'S STILL GET SOME MORE INFORMATION ON VITAMIN D?

585

MR. WADE: AND LET'S GO UP TO THE TOP.

586

ADAM ROSENDORFF: THERE IS A REQUIREMENT FOR INSTRUMENT-TO-INSTRUMENT COMPARISON WITHIN BOTH CAP AND CLIA REGULATIONS WHERE YOU MAKE SURE THAT THE INSTRUMENTS ARE RETURNING COMPARABLE RESULTS. THAT'S A SEPARATE EXERCISE PT.

587

MR. WADE: AND THAT'S SOMETHING TOTALLY DIFFERENT FROM PT OR AAP; CORRECT?

588

ADAM ROSENDORFF: IT'S RELATED I WOULD SAY.

589

MR. WADE: BUT IT WASN'T WITHIN THAT POLICY THAT YOU PREPARED; CORRECT?

591

MR. WADE: OKAY. LET'S -- THIS IS MORE ON TRACK WITH THE POLICY THAT YOU PREPARED; RIGHT?

592

ADAM ROSENDORFF: YES. THERE WAS NOTHING IN THAT POLICY ABOUT RUNNING IT ON DIFFERENT INSTRUMENTS THOUGH.

593

MR. WADE: OKAY. AND YOU AND DR. YOUNG PREPARED THAT POLICY; CORRECT?

595

MR. WADE: AND YOU SIGNED THAT POLICY?

597

MR. WADE: AND YOU THOUGHT IT WAS A GOOD POLICY AT THE TIME; RIGHT?

599

MR. WADE: AND THIS IS BEING DONE CONSISTENT WITH THAT; RIGHT?

601

MR. WADE: OKAY. AND IF WE GO UP THE CHAIN TO THE LAST EMAIL IN THIS CHAIN DR. PANDORI AGREES. DO YOU SEE THAT? AND HE NOTES -- HE ATTACHES A PAPER ABOUT VITAMIN D VARIABILITY. DO YOU SEE THAT?

603

MR. WADE: AND VARIABILITY IS A CONCEPT THAT WE'VE TALKED ABOUT A LITTLE BIT IN YOUR TESTIMONY. DO YOU RECALL THAT?

605

MR. WADE: AND VITAMIN D IS ACTUALLY NOTORIOUSLY KIND OF A DIFFICULT ASSAY; CORRECT?

606

ADAM ROSENDORFF: IT'S DONE A NUMBER OF DIFFERENT WAYS. IT'S DONE MASS SPEC, MASS SPECTROMETRY, LIPID CHROMATOGRAPHY, MASS SPECTROMETRY, AND IT'S PROBABLY THE MOST ACCURATE WAY OF QUANTIFYING VITAMIN D AND ITS VARIOUS METABOLITES. DIASORIN IS CONSIDERED A VERY GOOD PLATFORM TO MEASURE VITAMIN D IN THE INDUSTRY AT THE TIME.

607

MR. WADE: DO YOU SEE HERE IN THE LAST SENTENCE DR. PANDORI NOTES THAT VITAMIN D SEEMS NOTORIOUS FOR VARIABILITY ON EVEN FDA APPROVED TESTS. DO YOU SEE THAT?

608

ADAM ROSENDORFF: THAT'S HIS ASSERTION, YES.

609

MR. WADE: YEAH. OKAY. DID YOU DISAGREE WITH THIS ASSERTION AT THIS TIME? I DIDN'T SEE A RESPONSE FROM YOU.

610

ADAM ROSENDORFF: I DIDN'T READ HIS PAPER. I DON'T RECALL WHAT MY THOUGHTS WERE ON THAT.

611

MR. WADE: LET'S GO TO 1593 -- I'M SORRY, 12593. AND WHILE YOU'RE LOOKING FOR THAT, LET ME ASK YOU THIS. THAT EMAIL THAT WE JUST WENT THROUGH --

613

MR. WADE: -- DID THE GOVERNMENT SHOW YOU THAT IN CONNECTION WITH THE PREPARATION OF YOUR TESTIMONY HERE?

615

MR. WADE: LET'S GO TO 12593.

617

MR. WADE: LET'S GO -- DO YOU SEE THIS IS AN EMAIL ON THE BOTTOM BETWEEN YOU, DR. PANDORI, AND DR. ROSENDORFF ABOUT THE SUBJECT PT PLAN AND COMMUNICATION?

620

MR. WADE: MOVE THE ADMISSION OF 12593.

621

MR. BOSTIC: NO OBJECTION.

622

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

623

(DEFENDANT'S EXHIBIT 12593 WAS RECEIVED IN EVIDENCE.)

624

BY MR. WADE:

625

MR. WADE: LET'S GO TO THE BOTTOM EMAIL. DO YOU SEE THAT'S AN EMAIL FROM MR. BALWANI TO DR. PANDORI AND YOU?

627

MR. WADE: AND THE SUBJECT IS PT PLAN AND COMMUNICATION?

629

MR. WADE: AND PT IS PROFICIENCY TESTING?

631

MR. WADE: AND IT SAYS, "PER OUR CONVERSATION FROM THIS WEEK, I WOULD LIKE A COMMUNICATIONS PLAN CLEARLY DOCUMENTED ON HOW WE DO AAP FOR PT." DO YOU SEE THAT?

633

MR. WADE: AND IT SAYS, "THE SOP FOR THIS HAS ALWAYS BEEN IN PLACE, BUT YOU MENTIONED YOU DIDN'T KNOW ABOUT THIS UNTIL THIS WEEK AND NOW THAT YOU HAVE READ IT, YOU WANTED TO ADD A FEW MINOR CLARIFYING DETAILS TO THIS." DO YOU SEE THAT?

635

MR. WADE: AND THAT REFERS TO DR. PANDORI; CORRECT?

637

MR. WADE: AND BECAUSE DR. PANDORI JOINED THE COMPANY AFTER YOU IMPLEMENTED THAT PLAN, THAT POLICY?

638

ADAM ROSENDORFF: I HAD WRITTEN THE POLICY.

639

MR. WADE: RIGHT. AND SO HE BECAME AWARE OF IT DURING THIS TIME PERIOD?

641

MR. WADE: AND HE SAYS PLEASE CORRECT ME IF I MISUNDERSTOOD THIS; RIGHT?

643

MR. WADE: AND NEXT PARAGRAPH HE SAYS, "MORE IMPORTANTLY THOUGH, I WANT OUR AAP SOP PROCESS IN A POWERPOINT IN WHICH THIS COULD BE EASILY EXPLAINED AND UNDERSTOOD BY OTHERS IN CLIA." DO YOU SEE THAT?

645

MR. WADE: AND THIS WAS BECAUSE THERE WAS SOME OF THAT CONFUSION RELATING TO THE AAP WITHIN CLIA; RIGHT?

647

MR. WADE: AND SO WHAT HE WAS ASKING FOR WAS A POWERPOINT THAT EXPLAINED THE POLICY TO EVERYONE WITHIN CLIA; RIGHT?

649

MR. WADE: AND SO THERE WAS NO CONFUSION?

651

MR. WADE: AND IF YOU GO TO THE BOTTOM PARAGRAPH THERE HE ACTUALLY ASKS FOR THAT. HE WANTS YOU TO DO THIS, CREATE THIS POWERPOINT, AND THEN SHOW THAT POWERPOINT TO EVERYONE IN THE GROUP; RIGHT?

653

MR. WADE: AND THAT'S WHAT YOU DID; RIGHT?

654

ADAM ROSENDORFF: I DON'T RECALL ME SHOWING IT TO THE GROUP MYSELF. I THINK MARK DID.

655

MR. WADE: OKAY. WELL, LET'S GO UP THE CHAIN. THE NEXT EMAIL. AND HERE YOU SAY -- THIS IS AN EMAIL FROM YOU TO MR. BALWANI COPYING MR. PANDORI; RIGHT?

657

MR. WADE: AND -- BUT YOU'RE ADDRESSING MR. BALWANI?

659

MR. WADE: AND YOU SAY, "I HAVE MODIFIED THE SOP TO REFLECT OUR CURRENT AAP." DO YOU SEE THAT?

661

MR. WADE: BUT MINOR CHANGES ONLY; RIGHT?

663

MR. WADE: AND YOU ADDED A SECTION ON THE ACCEPTANCE CRITERIA IN CORRECTIVE ACTIONS; RIGHT?

665

MR. WADE: AND HOW TO DEAL WITH PROBLEMS IF THEY ARISE?

667

MR. WADE: AND BECAUSE SOMETIMES THEY ARISE; RIGHT?

669

MR. WADE: AND THEN YOU SAY, "MARK AND I WILL PUT TOGETHER A POWERPOINT THAT WE CAN COMMUNICATE IN OUR CLIA GENERAL MEETING." DO YOU SEE THAT?

671

MR. WADE: AND DID HE DO THAT, SIR?

672

ADAM ROSENDORFF: MARK PUT IT TOGETHER.

673

MR. WADE: AND DID YOU COMMUNICATE IT IN THE GENERAL CLIA MEETING WITH MARK PANDORI?

674

ADAM ROSENDORFF: I DO NOT RECALL.

675

MR. WADE: AND THEN YOU SAY, DO YOU SEE THE LAST SENTENCE --

677

MR. WADE: IT SAYS, "I AGREE THAT MISCONCEPTIONS AROUND THIS NEED TO BE DISPELLED." DO YOU SEE THAT?

679

MR. WADE: AND THAT WAS YOUR VIEW AT THE TIME; CORRECT?

681

MR. WADE: DID THE GOVERNMENT SHOW YOU THIS EMAIL IN YOUR PREP SESSION?

683

MR. WADE: LET'S GO TO EXHIBIT 13921.

685

MR. WADE: AND THIS IS AN EMAIL FROM YOU TO MARK PANDORI COPYING MR. BALWANI; CORRECT?

687

MR. WADE: AND THE SUBJECT RELATES TO PROFICIENCY TESTING ON THE EDISON 3.5 DEVICES?

689

MR. WADE: MOVE THE ADMISSION OF 13921.

690

MR. BOSTIC: NO OBJECTION.

691

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

692

(DEFENDANT'S EXHIBIT 13921 WAS RECEIVED IN EVIDENCE.)

693

BY MR. WADE:

694

MR. WADE: AND THIS SAYS -- THIS IS AN EMAIL WHERE YOU'RE COMMUNICATING THAT ATTACHED UPDATED EDISON AAP PROTOCOL; CORRECT?

696

MR. WADE: AND THAT'S EXACTLY WHAT YOU SAID -- THIS REFLECTS THE CHANGES THAT YOU MENTIONED TO MR. BALWANI IN THE PRIOR EMAIL; CORRECT?

698

MR. WADE: AND THAT DOCUMENT IS ATTACHED AT -- IN THE FOLLOWING PAGES, IS IT NOT?

699

ADAM ROSENDORFF: I'M SORRY, COULD YOU REPEAT?

700

MR. WADE: SURE. THE POLICY ITSELF --

702

MR. WADE: -- THE PROCEDURE SOP FOR PROFICIENCY TESTING FOR THERANOS LAB DEVELOPED TESTS ON THE EDISON 3.5 DEVICES IS ATTACHED TO THAT EMAIL; CORRECT?

704

MR. WADE: THIS WAS -- IS NOT THE SIGNED VERSION. YOU WERE JUST SENDING AN ELECTRONIC VERSION TO THEM VIA EMAIL; CORRECT?

706

MR. WADE: OKAY. LET'S GO TO 7440.

708

MR. WADE: AND THIS IS AN EMAIL FROM DR. PANDORI TO YOU AND MR. BALWANI IN APRIL, MID-APRIL 2014; CORRECT?

710

MR. WADE: AND IT ATTACHES A POWERPOINT?

712

MR. WADE: MOVE THE ADMISSION OF 7440.

713

MR. BOSTIC: NO OBJECTION.

714

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

715

(DEFENDANT'S EXHIBIT 7440 WAS RECEIVED IN EVIDENCE.)

716

BY MR. WADE:

717

MR. WADE: THIS IS AN EMAIL WHERE DR. PANDORI IS FOLLOWING THROUGH WITH A DISCUSSION WITH MR. BALWANI AND HE'S COMMUNICATING THE POWERPOINT PRESENTATION THAT WAS PREPARED; CORRECT?

719

MR. WADE: AND THIS WAS TO TRY TO DISPEL THE CONFUSION THAT WAS EXISTING WITHIN CLIA LAB ABOUT AAP AND PT?

721

MR. WADE: LET'S TAKE A LOOK AT THAT POWERPOINT. DO YOU SEE THE SUBJECT LINE HERE AND THAT'S A PICTURE OF THE SIGN FOR THE LOCATION OF THE LAB; IS THAT RIGHT?

723

MR. WADE: OKAY. AND LET'S GO TO THE NEXT PAGE. THIS JUST PROVIDES THE GENERAL FRAMEWORK FOR WHAT IS REQUIRED FOR PROFICIENCY TESTING BY CMS; RIGHT?

725

MR. WADE: AND THEN IF YOU GO TO THE NEXT PAGE. WE TALKED A LITTLE BUILT ABOUT A TARGET THE OTHER DAY. PROFICIENCY TESTING IS DESIGNED TO ASSESS ACCURACY; RIGHT?

727

MR. WADE: AND, IN FACT, THE SECOND POINT THERE DO YOU SEE IT SAYS, "YOUR LAB IS COMPARED TO PEER GROUPS ON THE BASIS OF EQUIPMENT." RIGHT?

729

MR. WADE: AND SO THAT'S KIND OF THE APPLES TO APPLES THAT HAS BEEN REFERRED TO; RIGHT? YOU NEED A PEER GROUP?

731

MR. WADE: LET'S GO TO THE NEXT PAGE. AND HERE IT SAYS, "THERANOS TESTS HAVE NO PEER GROUPS." RIGHT?

732

ADAM ROSENDORFF: I CAN CLARIFY IF NEEDED, OR IF NOT, WE WILL CONTINUE WITH THE DISCUSSION.

733

MR. WADE: WELL, YOU WERE SENT THIS IN ADVANCE?

735

MR. WADE: AND YOU ACTUALLY PROVIDED COMMENTS ON THIS. DO YOU RECALL THAT?

736

ADAM ROSENDORFF: ON THE POWERPOINT?

737

MR. WADE: YEAH. DO YOU RECALL DOING THAT?

739

MR. WADE: BUT YOU WERE CERTAINLY SENT IT IN THIS EMAIL?

741

MR. WADE: AND DID YOU AGREE IT WAS ACCURATE AT THE TIME?

742

ADAM ROSENDORFF: THAT WHAT WAS ACCURATE?

743

MR. WADE: THE POWERPOINT. DO YOU THINK IT ACCURATELY CAPTURED PT AND AAP?

744

ADAM ROSENDORFF: THIS INTENTION WAS MORE IN THE VEIN OF WHAT I NEED TO DO. SITTING HERE AND GOING THROUGH THE DOCUMENTS, IT LOOKS LIKE THIS WAS ONLY DONE FOR VITAMIN D PER THE PREVIOUS EMAILS WE WERE REVIEWING, YEAH.

745

MR. WADE: SIR, DO YOU RECALL IN THE PREVIOUS EMAILS THERE'S AN INDICATION FROM DR. PANDORI THAT THEY WERE DOING VITAMIN D; CORRECT?

747

MR. WADE: AND THERE'S AN INDICATION FROM MR. BALWANI THAT HE WANTED TO DO EVEN MORE VITAMIN D TESTING; RIGHT?

749

MR. WADE: AND DR. PANDORI DIDN'T WANT TO DO MORE TESTING BECAUSE HE WANTED TO DO PT ON OTHER ANALYTES; CORRECT?

751

MR. WADE: AND THAT WAS IN THE WEEKS PRECEDING THIS APRIL 17TH, 2014, PRESENTATION; CORRECT?

753

MR. WADE: NOW, MY QUESTION FOR YOU, SIR, IS DID YOU HAVE ANY REASON TO QUESTION THE ACCURACY OF THIS SLIDE DECK AT THE TIME THAT YOU RECEIVED IT FROM DR. PANDORI?

754

ADAM ROSENDORFF: I THINK THE SLIDE DECK REFLECTED WHAT I HAD WRITTEN IN THE SOP.

755

MR. WADE: OKAY. NOW, LET'S GO BACK TO THIS EMAIL. IT SAYS, "THERANOS TESTS HAVE NO PEER GROUPS." DO YOU SEE THAT?

757

MR. WADE: I'M SORRY, IF WE CAN GO BACK TO THE POWERPOINT. ONE MORE PAGE. THERE YOU GO. DO YOU HAVE THAT IN FRONT OF YOU ON THE SCREEN?

759

MR. WADE: IT SAYS, "NORMAL PROCESS OF PS IS THEREFORE NOT APPROPRIATE." RIGHT?

761

MR. WADE: IT SAYS, "ADDITIONALLY, THE SYNTHETIC MATRIX OF MANY COMMERCIALLY AVAILABLE PT SAMPLES IS NOT AN APPROPRIATE ONE FOR MANY THERANOS TESTS." RIGHT? DO YOU SEE THAT?

762

ADAM ROSENDORFF: THAT'S WHAT I'M READING, YES.

763

MR. WADE: OKAY. AND I BELIEVE YOU JUST TESTIFIED THAT THIS ACCURATELY REFLECTS YOUR POLICY?

765

MR. WADE: ALL RIGHT. AND THEN IT EXPLAINS, IF WE GO TO THE NEXT SLIDE, "HOW IS PT PERFORMED THEN ON THERANOS TESTS?" DO YOU SEE THAT?

767

MR. WADE: AND IT TALKS ABOUT HOW YOU LOOK TO THE CLINICAL AND LABORATORY INSTITUTE. DO YOU SEE THAT?

769

MR. WADE: AND SOMETIMES IT'S REFERRED TO AS THE CLSI?

771

MR. WADE: AND THAT'S A VERY AUTHORITATIVE GROUP; CORRECT?

773

MR. WADE: AND SO YOU AND DR. PANDORI LOOKED TO THAT FOR GUIDANCE; CORRECT?

775

MR. WADE: LET'S GO TO THE NEXT SLIDE. AND IT EXPLAINS OUR AAP INCLUDES A COMPARISON OF A PREDICATE FDA APPROVED METHOD. THAT'S THE GOLD STANDARD; RIGHT?

777

MR. WADE: TO THE THERANOS METHODS; RIGHT?

779

MR. WADE: AND THEN IT SAYS USES ACTUAL CLINICAL SPECIMENS. DO YOU SEE THAT?

781

MR. WADE: AND THAT'S TO AVOID THAT SYNTHETIC MATRIX ISSUE THAT WAS ON THE PRIOR SLIDE; RIGHT?

782

ADAM ROSENDORFF: I CAN'T ANSWER YES OR NO TO THAT QUESTION.

783

MR. WADE: SO YOU DON'T KNOW?

784

ADAM ROSENDORFF: ARE YOU ASKING FOR MY OPINION?

785

MR. WADE: I'M, I'M ASKING IF THE REASON -- IF THAT WAS THE REASON THAT THE AAP METHOD WAS USED WAS TO AVOID CONCERNS ABOUT THE MATRIX EFFECTS, AMONG OTHER REASONS?

786

ADAM ROSENDORFF: THOSE WERE SOME OF THE REASONS THAT HAD BEEN PROPOSED.

787

MR. WADE: OKAY. AND THAT'S THE REASON THAT DR. PANDORI REFLECTED IN THIS POWERPOINT; RIGHT?

789

MR. WADE: AND LET'S GO TO THE NEXT PAGE. SIR, CAN YOU READ THAT FIRST BULLET FOR US, THE FIRST AT THE TOP OF THE PAGE?

790

ADAM ROSENDORFF: "THE THERANOS AAP IS SUPERIOR TO STANDARD PT, AND WILL PROVIDE EVEN MORE QUALITY ASSURANCE."

791

MR. WADE: THANK YOU. LET'S GO TO THE NEXT SLIDE. AND THIS TALKS ABOUT THE RESULTS; RIGHT?

793

MR. WADE: AND IT SAYS IF AAP SHOWED ANYTHING WRONG WITH A TEST, IT CAN BE CAPTURED AND REPAIRED VERY QUICKLY; RIGHT?

795

MR. WADE: THAT'S THE GOAL; RIGHT?

797

MR. WADE: TO MAKE SURE THAT THE TEST REMAINS SAFE AND ACCURATE; RIGHT?

798

ADAM ROSENDORFF: ARE YOU ASKING ME IF PROBLEMS WERE REPAIRED QUICKLY IN REALTIME?

799

MR. WADE: I'M ASKING YOU IF THAT WAS THE GOAL OF THE IMPLEMENTATION OF THIS POLICY IN THIS SLIDE DECK?

800

ADAM ROSENDORFF: WELL, THAT'S THE IDEAL -- THAT WOULD BE IDEAL, YES.

801

MR. WADE: OKAY. GREAT. THEN THERE WAS AN OPPORTUNITY TO ASK QUESTIONS. DO YOU RECALL WHETHER THERE WERE ANY QUESTIONS ASKED?

802

ADAM ROSENDORFF: I DO NOT RECALL.

803

MR. WADE: BUT THE IDEA WAS THAT MR. BALWANI AND YOU AND DR. PANDORI WANTED TO PUT THIS INFORMATION OUT THERE TO EVERYONE IN THE CLIA LAB AND GIVE THEM A CHANCE TO UNDERSTAND IT AND TO ASK QUESTIONS; RIGHT?

805

MR. WADE: OKAY. NOW, I WANT TO JUMP AHEAD A LITTLE BIT TO THE FALL OF 2014. OKAY?

807

MR. WADE: AND ON WEDNESDAY DURING YOUR TESTIMONY WE TALKED ABOUT A MEETING THAT YOU HAD HAD WITH S.E.C. ATTORNEYS AND SOME OF THE PROSECUTORS IN 2016 WHERE YOU STATED THAT THERE WERE GOOD RESULTS FROM AAP ON THE EDISON MACHINES. DO YOU RECALL THAT?

809

MR. WADE: AND WHAT I'D LIKE TO DO IS WALK YOU THROUGH SOME OF THE EVENTS IN THE FALL. IF WE CAN GO TO EXHIBIT 12846. BY THE WAY, WHILE WE'RE LOOKING FOR THAT, THE POWERPOINT WE JUST WENT THROUGH, DID THE GOVERNMENT SHOW YOU THAT IN YOUR PREPARATION?

811

MR. WADE: THEY DID?

813

MR. WADE: ALL RIGHT. 12846, DO YOU SEE THAT?

815

MR. WADE: OKAY. I'D LIKE TO GO TO THE BOTTOM EMAIL.

816

ADAM ROSENDORFF: UH-HUH, YES.

817

MR. WADE: YOU RECOGNIZE THIS TO BE AN EMAIL BETWEEN YOU AND MS. KHAN AND CHRISTIAN HOLMES RELATING TO A PHYSICIAN INQUIRY IN OCTOBER OF 2013?

818

ADAM ROSENDORFF: ARE YOU REFERRING TO THE FIRST EMAIL ON THE FIRST PAGE?

819

MR. WADE: NO. IF YOU START ON THE BACK.

821

MR. WADE: DO YOU SEE THE SUBJECT PHYSICIAN INQUIRY?

823

MR. WADE: OKAY. AND THIS EMAIL STARTS WITH THE FOLLOWUP ON A PHYSICIAN INQUIRY RELATING TO A TEST. DO YOU SEE THAT?

824

ADAM ROSENDORFF: IT'S AN EMAIL FROM ANAM TO CHRISTIAN REGARDING A PHYSICIAN INQUIRY.

825

MR. WADE: RIGHT. DO YOU SEE THAT?

827

MR. WADE: AND ULTIMATELY YOU'RE LOOPED IN. DO YOU SEE THAT ON THE NEXT PAGE?

829

MR. WADE: OKAY. I'D MOVE THE ADMISSION OF EXHIBIT 12846.

830

MR. BOSTIC: NO OBJECTION.

831

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

832

(DEFENDANT'S EXHIBIT 12846 WAS RECEIVED IN EVIDENCE.)

833

MR. WADE: LET'S START AT THE BOTTOM OF THIS ONE, LAST EMAIL.

834

MR. WADE: OKAY. DO YOU SEE HERE THERE'S -- DO YOU REMEMBER MS. KHAN? IS SHE A CUSTOMER SERVICE REPRESENTATIVE?

836

MR. WADE: AND SHE'S A PERSON WHO SOMETIMES FORWARDS INQUIRIES THAT COME FROM PRACTICES; RIGHT?

838

MR. WADE: AND WE TALKED ABOUT THE OTHER DAY THERE ARE A LOT OF DIFFERENT INQUIRIES THAT COME FROM PRACTICES; RIGHT?

840

MR. WADE: AND SOME OF THEM CAN RELATE TO MINOR THINGS THAT ARE OF NO CONCERN TO YOU?

841

ADAM ROSENDORFF: I TOOK ALL OF THE INQUIRIES SERIOUSLY, SIR.

842

MR. WADE: OKAY. I'M GLAD TO HEAR THAT. BUT YOU WERE PARTICULARLY CONCERNED IF THERE WAS A MEDICAL INQUIRY; RIGHT?

843

ADAM ROSENDORFF: IT'S ALSO A MEDICAL ISSUE WHEN YOU'RE ISSUING LAB RESULTS TO PATIENTS.

844

MR. WADE: OKAY. BUT, FOR EXAMPLE, IF THE MEDICAL PRACTICE CALLED AND SAID WE NEED MORE FORMS, THAT'S NOT SOMETHING THAT YOU NECESSARILY NEED TO BE INVOLVED IN; RIGHT?

846

MR. WADE: OKAY. AND THERE COULD BE OTHER MINOR ISSUES THAT YOU MIGHT NOT NEED TO BE INVOLVED IN, RIGHT, DR. ROSENDORFF?

847

ADAM ROSENDORFF: SURE. CORRECT.

848

MR. WADE: THIS IS AN INQUIRY THAT COMES UP WITH RESPECT TO A PATIENT'S RESULTS. DO YOU SEE THAT?

850

MR. WADE: AND I WANT TO BE CAREFUL NOT TO IDENTIFY THE PATIENT. IT'S REDACTED ON THE SCREEN. OKAY? AND ONE OF THEM WAS, IF YOU GO UP THE CHAIN, MR. HOLMES SAYS, "WE WILL REPEAT THE TESTS, AND PLEASE PASS TO ADAM REGARDING HER REQUEST TO SPEAK WITH SOMEONE IN THE LAB." DO YOU SEE THAT?

852

MR. WADE: AND THAT'S EXACTLY WHAT YOU WANTED HAPPENING; RIGHT?

854

MR. WADE: AND DO YOU RECALL SOMETIMES MR. HOLMES WAS ASKED ABOUT REQUEST FOR REDRAWS BECAUSE HE HAD THE AUTHORITY TO WAIVE ANY CHARGES FOR THAT AND COULD GRANT A TEST AT NO COST IF ONE WAS REQUESTED?

855

ADAM ROSENDORFF: I HAVEN'T SEEN EMAILS ABOUT HIM WAIVING CHARGES. I HAVEN'T SEEN EMAILS ABOUT HIM APPROVING TESTS, APPROVING REDRAWS FOR THE PURPOSE OF WAIVING CHARGES.

856

MR. WADE: OKAY. AND I DIDN'T SEE IF YOU HAD SEEN EMAILS. WERE YOU AWARE THAT HE HAD THE AUTHORITY TO WAIVE CHARGES IF A TEST WAS REDONE?

857

ADAM ROSENDORFF: NO, I WAS NOT.

858

MR. WADE: OKAY. BUT HERE HE'S LOOPING YOU IN; CORRECT? DO YOU SEE THAT?

860

MR. WADE: AND IF WE GO TO THE NEXT EMAIL, MS. KHAN DOES JUST THAT; RIGHT?

862

MR. WADE: AND SHE SAYS, "CAN YOU PLEASE REACH OUT TO THIS PHYSICIAN. SHE HAS SOME QUESTIONS REGARDING HER PATIENT'S FT4 AND TSH RESULT." DO YOU SEE THAT?

864

MR. WADE: OKAY. AND YOU RESPOND, "SURE." DO YOU SEE THAT?

866

MR. WADE: AND ANOTHER ITEM THAT IS NOT RELATED TO THAT INQUIRY; RIGHT?

868

MR. WADE: OKAY. AND LET'S GO UP TO THE NEXT -- LET ME GO BACK TO THAT ONE EMAIL FOR JUST ONE SECOND. THAT'S ON OCTOBER 10TH, 2014; CORRECT?

870

MR. WADE: AND LET'S GO ONE EMAIL UP. HERE MS. KHAN EMAILS AGAIN; CORRECT?

872

MR. WADE: AND SHE SAYS, "CAN YOU PLEASE REACH OUT TO THIS PHYSICIAN? SHE CALLED AGAIN TODAY BECAUSE SHE HASN'T HEARD FROM ANYONE YET. SHE SENT HER PATIENT BACK YESTERDAY AND THE FT4 RESULT WAS LOW AGAIN." DO YOU SEE THAT?

874

MR. WADE: AND A WEEK HAD GONE BY AND YOU HAD NOT RETURNED THAT PHONE CALL, CORRECT, SIR?

875

ADAM ROSENDORFF: YES, IT APPEARS SO.

876

MR. WADE: OKAY. SO YOU ASKED FOR THE PHONE NUMBER. IF WE GO UP THE CHAIN, AND DO YOU SEE YOU ASKED FOR THE PHONE NUMBER AGAIN?

878

MR. WADE: AND THEN YOU WERE GOING TO CALL; RIGHT?

880

MR. WADE: AND WE ALL MAKE MISTAKES; RIGHT?

882

MR. WADE: LET'S GO TO THE NEXT PAGE. HERE YOU REPORT ON THE CALL WITH DR. KRAL. DO YOU SEE THAT?

884

MR. WADE: AND YOU SAY -- YOU EXPLAIN HOW SHE'S PUZZLED ABOUT THE RESULTS AND YOU EXPLAIN WHAT -- SOMETHING ABOUT WHAT YOU COMMUNICATED THERE. DO YOU SEE THAT?

886

MR. WADE: AND THEN DO YOU SEE THAT SHE SAYS WE DISCUSSED THE POSSIBILITY OF WHAT MIGHT BE CAUSING THE RESULTS. IT'S A VERY TECHNICAL ISSUE THERE; RIGHT?

888

MR. WADE: AND I DON'T WANT TO GET BOGGED DOWN IN THAT. BUT YOU ALSO SAY WE DISCUSSED THE EQUILIBRIUM DIALYSIS IS THE GOLD STANDARD ASSAY FOR FT4. DO YOU SEE THAT?

890

MR. WADE: AND DO YOU SEE THE NEXT SENTENCE THERE, IT SAYS, "THE M.D. IS EXTREMELY POSITIVE AND EXCITED ABOUT THERANOS AND WANTS US TO 'CRUSH QUEST DIAGNOSTICS'"?

891

ADAM ROSENDORFF: I SEE THAT.

892

MR. WADE: AND THAT'S WHAT WAS COMMUNICATED TO YOU FROM THAT DOCTOR?

894

MR. WADE: AND LET'S LOOK AT THIS NEXT ISSUE. AND, NO, I'M SORRY, THE BOTTOM EMAIL IN THAT CHAIN. IT STARTS "NOTE." I WANT TO FOCUS ON THAT. DO YOU SEE THAT?

896

MR. WADE: AND IT SAYS, "AAP PERFORMED ON 4/18/2014 INDICATES THAT THE THERANOS METHOD IS, ON AVERAGE, 10 PERCENT LOWER THAN PREDICATE." DO YOU SEE THAT?

898

MR. WADE: AND WHICH IS ACCEPTABLE?

900

MR. WADE: AND THAT WAS YOUR AAP; CORRECT?

901

ADAM ROSENDORFF: YES, IT APPEARS SO.

902

MR. WADE: AND LET'S GO UP THE CHAIN. YOU THEN FORWARD THIS TO MR. HOLMES. DO YOU SEE THAT?

904

MR. WADE: IF WE CAN CAPTURE ALL OF THE EMAILS AT THE TOP THERE. HE THANKS YOU FOR THE FEEDBACK. HE WANTS YOU TO KNOW THAT THE LOOP HAD BEEN CLOSED ON THAT; RIGHT.

906

MR. WADE: BECAUSE HE HAD A ROLE IN SUPERVISING CUSTOMER SERVICE; RIGHT?

908

MR. WADE: AND CUSTOMER SERVICE WAS IMPORTANT AT THERANOS, WAS IT NOT?

909

ADAM ROSENDORFF: I CAN'T ANSWER YES OR NO.

910

MR. WADE: WAS IT IMPORTANT TO YOU, SIR?

912

MR. WADE: OKAY. AND AS A GENERAL MATTER, YOU HAD RETURNED DOCTOR CALLS MUCH MORE QUICKLY THAN THAT I ASSUME.

914

MR. WADE: YEAH. LET'S GO TO EXHIBIT 13922.

916

MR. WADE: OKAY. AND DO YOU SEE THAT THIS IS AN ISSUE, ANOTHER PHYSICIAN CALL BACK ISSUE. THIS ONE IS IN LATE SEPTEMBER 2014. DO YOU SEE THAT?

918

MR. WADE: AND THIS ONE WAS SOME -- A QUESTION THAT APPEARS TO RELATE TO TESTOSTERONE; RIGHT?

920

MR. WADE: AND HERE -- MOVE TO ADMIT 13922.

921

MR. BOSTIC: NO OBJECTION.

922

JUDGE DAVILA: IT'S ADMITTED. YOU MAY PUBLISH.

923

(DEFENDANT'S EXHIBIT 13922 WAS RECEIVED IN EVIDENCE.)

924

BY MR. WADE:

925

MR. WADE: AND DO YOU SEE ON THIS EMAIL CHAIN THERE ARE A NUMBER OF PEOPLE INVOLVED IN THIS, RIGHT, UP AT THE TOP?

927

MR. WADE: AND ONE OF THEM IS MR. HOLMES; RIGHT? DO YOU SEE THAT?

929

MR. WADE: AND THIS WAS AN INQUIRY THAT HAD APPROPRIATELY BEEN REFERRED TO YOU ABOUT A CONSULTATION WITH A DOCTOR; RIGHT?

930

ADAM ROSENDORFF: I DON'T RECALL THE BACKGROUND. IT'S ME ASKING ABOUT AAP FOR TESTOSTERONE. I JUST DON'T REMEMBER THE BACKGROUND ON IT.

931

MR. WADE: OKAY. WELL, LET'S BLOW UP THAT SENTENCE. YOU WERE TALKING ABOUT WANTING TO GET THAT INFORMATION IN CONNECTION WITH YOUR INQUIRY ON THIS DOCTOR; RIGHT?

933

MR. WADE: OKAY. LET'S GO TO EXHIBIT 12793.

934

ADAM ROSENDORFF: AND SO THEY DIDN'T ACTUALLY ANSWER MY QUESTION HERE.

935

MR. WADE: I DON'T HAVE THAT EMAIL, SIR.

936

ADAM ROSENDORFF: I'M SORRY, WHICH EMAIL?

937

MR. WADE: I DON'T HAVE THE RESPONSIVE EMAIL TO PUT IN FRONT OF YOU.

938

ADAM ROSENDORFF: OH, I SEE. I SEE.

939

MR. WADE: COULD WE GO TO 12793.

941

MR. WADE: DO YOU HAVE THAT IN FRONT OF YOU?

943

MR. WADE: AND THIS FOLLOWS UP ON -- IF YOU GO TO -- DO YOU SEE THIS IS ANOTHER EMAIL ABOUT AN INQUIRY RELATING TO THE TESTOSTERONE ISSUE?

945

MR. WADE: OKAY. MOVE THE ADMISSION OF 12793.

946

MR. BOSTIC: NO OBJECTION.

947

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

948

(DEFENDANT'S EXHIBIT 12793 WAS RECEIVED IN EVIDENCE.)

949

BY MR. WADE:

950

MR. WADE: AND IF WE CAN GO TO THE LAST EMAIL.

952

MR. WADE: THIS IS -- I JUST WANT TO NOTE THIS IS AN ISSUE FOR A PHYSICIAN WHO CALLED; CORRECT?

954

MR. WADE: AND THEY'RE ASKING THAT A FOLLOWUP BE DONE?

956

MR. WADE: DO YOU SEE THAT?

958

MR. WADE: OKAY. IF WE GO UP TO THE 3:29 P.M. EMAIL, DO YOU SEE MS. SCHEER IS HELPFULLY PROVIDING INFORMATION AND REMINDING YOU TO CALL BECAUSE THE PHYSICIAN HAD WANTED TO CALL AT 4:00; RIGHT?

960

MR. WADE: AND SHE'S REMINDING YOU AT 3:30?

962

MR. WADE: OKAY. AND IF WE GO UP ONE EMAIL INITIALLY WHICH IS THE PRIOR PAGE, YOU RESPOND -- THIS IS OCTOBER 1ST, 2014. DO YOU SEE THAT?

964

MR. WADE: AND LET'S GO TO THE NEXT PAGE. ALL RIGHT. IF YOU CAN -- AND DO YOU SEE GENERALLY ALL OF THE REDACTED INFORMATION ON THERE?

966

MR. WADE: DO YOU SEE THAT ON THE SCREEN?

968

MR. WADE: THAT IS ALL PATIENT IDENTIFYING INFORMATION?

970

MR. WADE: AND YOU UNDERSTAND THAT WE'RE REDACTING IT HERE?

972

MR. WADE: FOR THAT PURPOSE?

973

ADAM ROSENDORFF: APPROPRIATELY.

974

MR. WADE: BECAUSE THAT'S IMPORTANT; RIGHT?

975

ADAM ROSENDORFF: TO PROTECT PHI, ABSOLUTELY. YES.

976

MR. WADE: AND IF YOU GO TO THE BOTTOM THERE, DO YOU SEE -- LET'S BLOW THAT UP. DO YOU SEE IT SAYS, "FINALLY, AS LAB DIRECTOR --" NOW THIS WAS A PATIENT INQUIRY WHERE YOU WERE ASKED TO TALK ABOUT TESTOSTERONE; RIGHT?

978

MR. WADE: AND YOU SAY, "FINALLY, AS LAB DIRECTOR, I NEED TO SIGN OFF ON PROFICIENCY TESTING/AAP FOR VITAMIN D AND TESTOSTERONE, WHICH HAVE BOTH BEEN IN PRODUCTION FOR ALMOST A YEAR, WITHOUT (TO MY KNOWLEDGE), A FULLY EXECUTED AAP PLAN AND DATA." DO YOU SEE THAT?

980

MR. WADE: AND YOU SAY, "THIS DATA NEEDS TO BE SHARED ALSO WITH OUR QA/QC DIRECTOR AND BE AVAILABLE FOR CLIA INSPECTIONS." DO YOU SEE THAT?

982

MR. WADE: AND THAT JUST KIND OF -- LET'S GO BACK UP TO THE HEADING OF THAT. THAT EMAIL WAS SOMEWHAT RAISED OUT OF NOWHERE AND YOU'RE ADDRESSING IT TO ELENA AND CHRISTIAN. DO YOU SEE THAT? IT'S ON THE SCREEN.

983

ADAM ROSENDORFF: AND MAX, YEAH.

984

MR. WADE: AND NOW, ELENA AND CHRISTIAN DON'T HAVE ANYTHING TO DO WITH AAP AND PT; CORRECT?

985

ADAM ROSENDORFF: THAT'S CORRECT.

986

MR. WADE: AND THEY HAVE NO ROLE IN THAT WHATSOEVER?

988

MR. WADE: AND IF THEY CAME IN THE LAB AND TRIED TO DO AAP AND PT, YOU WOULD THROW THEM OUT OF THE LAB, WOULDN'T YOU?

990

MR. WADE: OKAY. LET'S GO UP ONE EMAIL. YOU RESPOND TO -- YOU FORWARD THIS TO MR. BALWANI ON OCTOBER 1ST. DO YOU SEE THAT?

992

MR. WADE: NOW, LET'S GO TO EXHIBIT 7482.

993

ADAM ROSENDORFF: SO NOW MR. BALWANI IS AWARE OF MY REQUEST FOR THE AAP DATA.

994

MR. WADE: YES, I SEE THAT. LET'S GO TO 7482 AND DISCUSS THAT SOME MORE. OKAY?

996

MR. WADE: DO YOU HAVE THAT IN FRONT OF YOU?

998

MR. WADE: AND DO YOU SEE THAT AS AN EMAIL BETWEEN YOU AND MR. BALWANI?

1000

MR. WADE: ON OCTOBER 9TH, 2014?

1002

MR. WADE: AND IF YOU GO DOWN THE EMAIL CHAIN, THERE ARE A FEW OTHERS ON THE EMAIL CHAIN AS WELL, CHRISTIAN HOLMES. DO YOU SEE THAT?

1004

MR. WADE: IF I COULD PAUSE HERE FOR A SECOND. AND I WANT TO GO BACK TO 12793. OKAY. IF WE GO TO THE BOTTOM THERE -- WE'LL PUT IT UP ON THE SCREEN FOR YOU. IT WILL BE A QUICK ONE. IF WE GO TO THE BOTTOM THERE, YOU HAD RAISED THIS ISSUE -- YOU HAD GIVEN THE REPORT ON DR. PALMER; RIGHT?

1006

MR. WADE: AND THIS IS OCTOBER 1ST, 2014; RIGHT?

1008

MR. WADE: AND IF YOU GO TO THE NEXT PAGE THERE ARE SOME QUESTIONS THAT ARE RAISED THERE THAT NEEDED TO BE LOOKED INTO; CORRECT?

1009

ADAM ROSENDORFF: YES. THE FIRST TESTOSTERONE VALUES OF 280 AND 309 WERE VERY, VERY DIFFERENT FROM TESTOSTERONE THAT WAS TESTED A FEW DAYS LATER, WHICH WAS 705.

1010

MR. WADE: AND SO OCTOBER 1ST, THAT NEEDED TO BE LOOKED INTO; RIGHT?

1012

MR. WADE: AND LET'S GO BACK TO 7482, WHICH I CAN'T REMEMBER IF I MOVED IT INTO EVIDENCE. I WOULD MOVE IT INTO EVIDENCE IF I HAVEN'T.

1013

MR. BOSTIC: NO OBJECTION.

1014

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

1015

(DEFENDANT'S EXHIBIT 7482 WAS RECEIVED IN EVIDENCE.)

1016

BY MR. WADE:

1017

MR. WADE: IF WE CAN GO TO THE BACK PAGE AND THE BOTTOM EMAIL. IT'S SPLIT ACROSS TWO PAGES. DO YOU SEE THIS IS ABOUT DR. PALMER AGAIN? DO YOU SEE THAT?

1019

MR. WADE: YEAH, SORRY. I'LL GIVE YOU A SECOND TO FIND IT. 7482?

1021

MR. WADE: OKAY. AND THIS IS ABOUT DR. PALMER AGAIN. DO YOU SEE THAT?

1023

MR. WADE: AND THIS IS OCTOBER 9TH?

1025

MR. WADE: DO YOU SEE THAT?

1027

MR. WADE: AND AMELIA AGUIRRE?

1029

MR. WADE: SHE'S EMAILING YOU. AND IF WE GO OVER THE TEXT OF THE EMAIL IT SAYS, "WERE YOU SPEAKING WITH A DR. A. PALMER REGARDING FREE AND TOTAL TESTOSTERONE? HE SAID HE WAS WAITING FOR A CALLBACK ABOUT A PATIENT." DO YOU SEE THAT?

1030

ADAM ROSENDORFF: DON'T MENTION THE NAME.

1031

JUDGE DAVILA: STRIKE THAT.

1032

MR. WADE: CAN WE REMOVE THAT? MY APOLOGIES.

1033

JUDGE DAVILA: THAT'S STRICKEN FROM THE RECORD.

1034

BY MR. WADE:

1035

MR. WADE: THANK YOU, DOCTOR. MY APOLOGIES. DO YOU SEE THERE'S REFERENCE TO A PARTICULAR PATIENT THERE?

1037

MR. WADE: AND THAT'S THE SAME PATIENT THAT WAS DISCUSSED IN THE PRIOR EMAIL; CORRECT?

1039

MR. WADE: OKAY. AND THERE'S INFORMATION PROVIDED ON HOW TO REACH THE DOCTOR. DO YOU SEE THAT?

1041

MR. WADE: AND IT SAYS, "HE'S HOPING TO GET A CALL BACK TODAY." DO YOU SEE THAT?

1043

MR. WADE: OKAY. AND THEN LET'S LOOK -- NOW, HERE AGAIN, THIS HAD BEEN A WEEK SINCE YOU LAST TALKED TO THE DOCTOR; RIGHT?

1044

ADAM ROSENDORFF: MY RECOLLECTION IS THAT I DID TALK TO DR. PALMER ABOUT THIS.

1045

MR. WADE: YOU TALKED TO THE DOCTOR ON OCTOBER 1ST. WE SAW THAT. DO YOU REMEMBER?

1047

MR. WADE: AND THEN THIS IS OCTOBER 9TH AND THEY'RE SAYING --

1048

ADAM ROSENDORFF: DO YOU WANT US TO TALK AGAIN?

1049

MR. WADE: HE'S WAITING FOR A CALL BACK FROM YOU. DO YOU SEE THAT?

1050

ADAM ROSENDORFF: YES, YES, I SEE THAT.

1051

MR. WADE: OKAY. AND SO THIS IS ANOTHER INSTANCE IN THIS PERIOD IN EARLY OCTOBER WHERE ABOUT A WEEK HAD PAST SINCE YOU HAD RETURNED THE DOCTOR'S CALL; RIGHT?

1052

ADAM ROSENDORFF: I HAD ALREADY SPOKEN TO HIM ON ONE OCCASION AND MY -- IT WAS NOT MY UNDERSTANDING THAT HE WANTED ANOTHER PHONE CALL FROM ME.

1053

MR. WADE: OKAY. WELL, LET'S LOOK, LET'S LOOK UP -- AND IT'S IMPORTANT FOR YOU TO HANDLE THOSE CALLS WITH THE DOCTORS; RIGHT?

1055

MR. WADE: BECAUSE THAT'S MEDICAL INFORMATION AND YOU'RE THE ONE WHO IS QUALIFIED TO DO THAT; RIGHT?

1057

MR. WADE: OKAY. LET'S LOOK UP THE CHAIN.

1058

ADAM ROSENDORFF: I SEE IT ON THE SCREEN.

1059

MR. WADE: YEAH. OKAY. HERE YOU SAY LET CHRISTIAN HANDLE THIS?

1061

MR. WADE: AND WHICH IS EXACTLY THE THING THAT YOU HAD BEEN SAYING ON YOUR DIRECT EXAMINATION SHOULDN'T HAPPEN; CORRECT?

1062

ADAM ROSENDORFF: I, I CAN EXPLAIN. I DIDN'T FEEL I HAD A GOOD EXPLANATION FOR THE DISCREPANT TESTOSTERONE VALUES, AND I REALLY DIDN'T KNOW WHAT I COULD TELL THE PHYSICIAN MORE THAN I TOLD HIM ON THE FIRST PHONE CALL.

1063

MR. WADE: WELL, DON'T YOU THINK, DON'T YOU THINK UNDER YOUR OBLIGATIONS UNDER CLIA THAT IF A DOCTOR CALLS YOU AND ASKS FOR A CALL BACK TODAY ON A PATIENT MEDICAL ISSUE, THAT YOU AT LEAST OWE THEM A RETURN PHONE CALL?

1065

MR. WADE: OKAY. AND WAS THERE SOMETHING HAPPENING IN THIS PERIOD, DR. ROSENDORFF, THAT WAS -- APART FROM YOUR THING AT THERANOS THAT WAS MAKING IT DIFFICULT FOR YOU TO GET BACK TO DOCTORS BECAUSE THERE'S A COUPLE OF THESE THAT HAVE COME UP IN THIS PERIOD?

1066

ADAM ROSENDORFF: I WAS BECOMING FRUSTRATED AT MY INABILITY TO EXPLAIN DISCREPANT RESULTS. IT CULMINATED ON ONE OR TWO OCCASIONS WITH MY REFUSAL TO JUSTIFY THE DISCREPANT RESULTS TO PHYSICIANS.

1067

MR. WADE: RIGHT, BUT YOU'RE --

1069

MR. WADE: BUT YOU'RE JUST BEING ASKED TO CALL THE DOCTOR AND HAVE A CONVERSATION HERE; RIGHT?

1070

ADAM ROSENDORFF: YES. THE DOCTOR IS WANTING ME TO EXPLAIN WHY THE RESULTS ARE DISCREPANT.

1071

MR. WADE: WELL, THE DOCTOR IS ASKING FOR A CONVERSATION ABOUT A MEDICAL ISSUE; RIGHT?

1072

ADAM ROSENDORFF: LABORATORY ISSUE, YES.

1073

MR. WADE: YEAH. RELATING TO A PATIENT?

1075

MR. WADE: AND I BELIEVE IT'S YOUR TESTIMONY THAT THAT IS SOMETHING THAT YOU NEED TO BE THE PERSON TO HANDLE; CORRECT?

1077

MR. WADE: OKAY. BUT YOU'RE NOT DOING THAT, ARE YOU, SIR?

1078

ADAM ROSENDORFF: I CAN'T ANSWER YES OR NO.

1079

MR. WADE: THIS IS FORWARDED TO MR. HOLMES. DO YOU SEE THAT IF WE GO UP THE CHAIN?

1081

MR. WADE: OKAY. AND HE'S ASKED TO CALL DR. PALMER. DO YOU SEE THAT?

1083

MR. WADE: AND BECAUSE THAT'S WHAT YOU ASKED TO HAVE HAPPEN; RIGHT?

1086

ADAM ROSENDORFF: AS I MENTIONED, I HAD ALREADY SPOKEN TO DR. PALMER ON THIS ISSUE ON A PREVIOUS OCCASION.

1087

MR. WADE: RIGHT. AND YOU UNDERSTOOD FROM THE CUSTOMER SERVICE PERSON THAT THAT DOCTOR WANTED TO TALK TO YOU AGAIN THAT AFTERNOON?

1089

MR. WADE: OKAY. AND IF WE CAN TAKE THE REST OF THAT PAGE AND JUST -- MR. HOLMES SENDS THIS TO MAX FOSQUE AND SUNNY BALWANI. DO YOU SEE THAT?

1091

MR. WADE: AND MR. BALWANI RESPONDS? IF WE GO TO THE FIRST PAGE. DO YOU SEE THAT?

1093

MR. WADE: AND THIS IS HIS RESPONSE?

1095

MR. WADE: OKAY. AND IF WE JUST ZOOM OUT FOR A SECOND, IT'S A PRETTY DETAILED RESPONSE, ISN'T IT?

1096

ADAM ROSENDORFF: IT'S A LONG RESPONSE.

1097

MR. WADE: OKAY. AND LET'S LOOK AT THAT, OKAY?

1099

MR. WADE: IN THE FIRST PARAGRAPH HE ADDRESSES ISSUES THAT ARE SPECIFIC TO THE QUESTION FROM THE DOCTOR. DO YOU SEE THAT?

1101

MR. WADE: OKAY. AND HE PROVIDES INFORMATION RELATING TO THAT PATIENT; RIGHT?

1103

MR. WADE: AND THEN IF YOU SEE -- AND WE TALKED ABOUT WHEN THERE'S A PATIENT INQUIRY, SOMETIMES INFORMATION WOULD BE GATHERED AND IT WOULD BE PROVIDED SO IT COULD BE CONSIDERED AND ANALYZED IN CONNECTION WITH RESPONDING TO THE DOCTOR; RIGHT?

1105

MR. WADE: OKAY. AND IN THE SECOND PARAGRAPH HE ADDRESSES THE ISSUE THAT YOU HAD RAISED IN THE OTHER EMAIL ABOUT AAP?

1109

MR. WADE: OKAY. AND HE NOTES, "WE ARE DOING MONTHLY (MOST CASES WEEKLY) IQP (AAP) FOR EACH ASSAY ON EDISONS AND OTHER DEVICES DOWNSTAIRS." DO YOU SEE THAT?

1112

ADAM ROSENDORFF: I DON'T AGREE WITH IT, BUT I SEE IT.

1113

MR. WADE: AND HE SAYS, "ALL OF THIS DATA IS 100 PERCENT ON THE FOLDERS ACCESSIBLE TO YOU AND HAD BEEN AGREED UPON OVER 6 MONTHS AGO." DO YOU SEE THAT?

1115

MR. WADE: AND HE SAYS, "WE SHOULD TAKE THIS DATA AND FORMALIZE IT FOR THE REVIEW AND SIGN OFF." DO YOU SEE THAT?

1117

MR. WADE: AND HE SAYS, "LANGLY IS NOT THE RIGHT PERSON FOR THIS AS HE IS BARELY KEEPING UP WITH OTHER WORK." DO YOU SEE THAT?

1119

MR. WADE: AND THEN HE SAYS, "AS YOU MAY RECALL, WE ARE DOING EQUIVALENT AAP ON A WEEKLY BASES." DO YOU SEE THAT?

1121

MR. WADE: AND THEN IF YOU GO DOWN A LITTLE BIT HE TALKS ABOUT THE POWERPOINT. DO YOU SEE THAT?

1123

MR. WADE: AND HE SAYS, "YOU AND MARK HAD CREATED A POWERPOINT FOR CLIA TEAM AND YOU GUYS ACTUALLY HAD POINTED OUT THAT DOING THIS WEEKLY JUST MAY BE TOO EXCESSIVE." DO YOU SEE THAT?

1125

MR. WADE: AND THAT'S THAT DR. PANDORI EMAIL THAT WE JUST TALKED ABOUT, DR. PANDORI SAID IT WAS A LITTLE EXCESSIVE BECAUSE IT WOULD INTERFERE WITH THE OPERATIONS. DO YOU RECALL THAT?

1127

MR. WADE: AND THAT'S WHAT HE'S REFERRING TO RIGHT HERE SIX MONTHS LATER; RIGHT?

1129

MR. WADE: OKAY. AND THEN THE LAST SENTENCE HE SAYS WE'RE ONLY REQUIRED TO DO THESE AAP'S ONCE PER FOUR MONTHS. DO YOU SEE THAT?

1131

MR. WADE: AND IT WAS ACTUALLY ONCE PER SIX MONTHS PER THE POLICY; RIGHT?

1133

MR. WADE: OKAY. LET'S GO TO THE NEXT PARAGRAPH. THIS PARAGRAPH TALKS ABOUT SOMETHING YOU KNOW WELL. IT SAYS IN ADDITION WE HAVE SEPARATE DAILY QC; RIGHT?

1135

MR. WADE: AND THAT ALL OF THE ASSAYS AND ALL DEVICES FOR CLIA AND THAT IS ALREADY IN PLACE FOR EACH DEVICE AND ASSAY. DO YOU SEE THAT?

1137

MR. WADE: AND YOU AGREED WITH THAT; RIGHT? THAT WAS BEING DONE?

1139

MR. WADE: OKAY. LET'S GO TO THE NEXT PARAGRAPH. NOW, HERE HE NOTES THAT A GROUP OF THEM LOOK AT THIS DATA ON ALMOST A DAILY BASIS. DO YOU SEE THAT?

1141

MR. WADE: AND WHILE IT'S NOT NEEDED FOR CLIA, IT'S ACTUALLY -- DOING THAT REGULAR TESTING OF ACCURACY WAS HELPFUL FOR R&D HE SAYS HERE; RIGHT?

1142

ADAM ROSENDORFF: I DON'T SEE THAT.

1143

MR. WADE: OKAY. LET ME READ THE SECOND SENTENCE. DO YOU SEE WHERE HE SAYS THEY'RE LOOKING AT IT ALMOST DAILY? DO YOU SEE THAT?

1145

MR. WADE: AND "HE" IS MR. BALWANI?

1147

MR. WADE: AND THEN YOU HAVE DR. PANGARKAR?

1149

MR. WADE: DR. YOUNG?

1151

MR. WADE: DR. DOSHI?

1153

MR. WADE: AND THEY'RE LOOKING AT THAT IQP APP DATA ON ALMOST A DAILY BASIS; IS THAT RIGHT?

1155

MR. WADE: OKAY. AND THEN IT SAYS, THIS IS NOT NEEDED FOR CLIA PURPOSES. THAT'S TRUE, RIGHT, YOU DIDN'T NEED DAILY AAP FOR CLIA?

1156

ADAM ROSENDORFF: NOT DAILY. YOU NEED A PROFICIENCY PROGRAM.

1159

MR. WADE: BUT HE SAYS FOR PRODUCT DEVELOPMENT AND PRODUCT IMPROVEMENT PURPOSES IT'S USEFUL; RIGHT?

1161

MR. WADE: AND THEN HE SAYS, "I WOULD RECOMMEND IF YOU WANT TO GET WEEKLY BRIEFINGS ON THIS, YOU SET UP TIME WITH NISHIT AND CHINMAY ON THE 13 ELISA ASSAYS, CBC, AND ADVIA ASSAYS, AND I KNOW THEY WILL BE VERY HAPPY IN WALKING YOU THRU THIS." DO YOU SEE THIS?

1162

ADAM ROSENDORFF: THOSE FOLKS WERE NOT IMPLEMENTING THE AAP AS I SET OUT IN MY SOP FOR THOSE 13 ASSAYS. I'M NOT CLEAR ON EXACTLY WHAT THEY WERE DOING AND THE DATA WAS NOT ACCESSIBLE IN THE DRIVE AS SUNNY IS ASSERTING.

1163

MR. WADE: WELL, HE'S SAYING RIGHT HERE IN THIS EMAIL, IF YOU WANT IT, YOU CAN GET A WEEKLY BRIEFING ON IT; CORRECT?

1165

MR. WADE: AND THAT'S WHAT HE'S SAYING RIGHT THERE?

1167

MR. WADE: AND HE'S SAYING WHAT IS HAPPENING; RIGHT?

1169

MR. WADE: AND DID YOU GO AND GET THAT BRIEFING?

1170

ADAM ROSENDORFF: I WENT INTO THE FILE TO TRY TO PULL UP THE AAP DATA.

1172

ADAM ROSENDORFF: IT WAS HARDLY INCOMPLETE.

1173

MR. WADE: OKAY. DID YOU TALK TO THESE FOLKS ABOUT WHAT YOU WERE DOING?

1174

ADAM ROSENDORFF: I SPOKE TO CHINMAY ABOUT AAP FOR CBC'S.

1175

MR. WADE: OKAY. LET'S CONTINUE WITH THIS EMAIL. DID YOU GO -- IN RESPONSE TO THIS SUGGESTION FROM MR. BALWANI, IS IT YOUR TESTIMONY THAT IN OCTOBER IN 2014 YOU ACTUALLY WENT AND HAD MEETINGS ABOUT THIS?

1176

ADAM ROSENDORFF: I DON'T RECALL.

1177

MR. WADE: OKAY. AND IF YOU LOOK AT THE BOTTOM, NUMBER 6, IT SAYS, "DESPITE ALL OF OUR BEST EFFORTS, THERE WILL BE RESULTS THAT ARE UNEXPECTED." NOW, YOU WOULD AGREE WITH THAT; RIGHT?

1179

MR. WADE: AND NO LAB IS PERFECT; RIGHT?

1181

MR. WADE: EVERY LAB MAKES SOME ERRORS?

1183

MR. WADE: THE -- HOWEVER, IF THERE ARE ANY DISCREPANCIES IN RESULTS, THE BEST IS TO INVESTIGATE, WHICH IS WHAT WE ALWAYS DO." DO YOU SEE THAT?

1185

MR. WADE: OKAY. AND THEN HE SAYS, "IN THAT REGARD, THE TEAM WOULD APPRECIATE YOUR INVOLVEMENT IN THAT PROCESS BUT YOU NEED TO BRING UP THE RIGHT ISSUES TO THE RIGHT PEOPLE." RIGHT?

1187

MR. WADE: HE SAYS, "THE ATTACHED EMAIL," WHICH WAS THE EMAIL, THE OCTOBER EMAIL WHERE YOU RAISED THIS ISSUE WITH THE CUSTOMER SERVICE REPRESENTATIVE AND MR. HOLMES --

1189

MR. WADE: -- HE DIDN'T THINK THAT WAS APPROPRIATE, DID HE?

1190

ADAM ROSENDORFF: I DID NOT ADDRESS THAT REQUEST TO THE RIGHT PEOPLE TO SOLVE THAT PROBLEM.

1191

MR. WADE: OKAY. SO YOU AGREE WITH HIM THAT THAT WAS NOT ADDRESSED TO THE RIGHT PEOPLE?

1194

ADAM ROSENDORFF: I THINK THE PURPOSE OF MY REQUEST WAS TO MAKE CHRISTIAN AWARE THAT MY REVIEW OF THE AAP WAS NOT BEING PROVIDED TO ME AND NOT BEING DONE. THAT -- YOU KNOW, ONE PROBLEM AND THE ROOT CAUSE OF THE INVESTIGATION WAS THAT THE AAP WAS INCOMPLETE ESSENTIALLY.

1195

MR. WADE: ALL RIGHT. BUT YOU AGREE WITH MR. BALWANI THAT THE PLACE TO RAISE ANY CONCERNS THAT YOU HAVE WITH THE AAP IS NOT WITH A CALL SERVICE REPRESENTATIVE; RIGHT?

1197

MR. WADE: BECAUSE THEY HAVE NO CONTROL OR ABILITY TO DEAL WITH THAT AT ALL; RIGHT?

1199

MR. WADE: DO YOU RECALL -- THIS EMAIL WAS SENT ON OCTOBER 9TH, 2014. DO YOU SEE THAT?

1201

MR. WADE: AND IF OUR GREENWICH MEAN TIME CALCULATOR IS RIGHT, THAT IS PROBABLY SOME POINT MIDAFTERNOON, SEVEN OR EIGHT HOURS, OR MAYBE IT'S 9:00 P.M.?

1202

ADAM ROSENDORFF: I DON'T KNOW.

1203

MR. WADE: OKAY. YOU DON'T KNOW. BUT IT'S ON OCTOBER 9TH, 2014?

1205

MR. WADE: DO YOU SEE THAT?

1207

MR. WADE: AND IN RESPONSE TO YOUR CONCERNS, A MEETING WAS SCHEDULED TO DISCUSS AAP; CORRECT?

1209

MR. WADE: AND LET'S GO TO 13 --

1210

ADAM ROSENDORFF: THAT'S BECAUSE IT WASN'T BEING IMPLEMENTED.

1211

MR. WADE: LET'S GO TO 7494.

1212

ADAM ROSENDORFF: I HAVE THAT.

1213

MR. WADE: DO YOU HAVE THAT IN FRONT OF YOU? AND DO YOU SEE THAT AS AN EMAIL AND A MEETING INVITE RELATING TO THAT MEETING AND IT ATTACHES ALSO A DRAFT POLICY? DO YOU SEE THAT?

1215

MR. WADE: MOVE THE ADMISSION OF 7494.

1216

MR. BOSTIC: NO OBJECTION.

1217

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

1218

(DEFENDANT'S EXHIBIT 7494 WAS RECEIVED IN EVIDENCE.)

1219

BY MR. WADE:

1220

MR. WADE: FOR NOW I JUST WANT TO DRAW YOUR ATTENTION TO THE BOTTOM OF THIS DOCUMENT. DO YOU SEE THAT THIS IS A, THIS IS A MEETING REQUEST FROM MR. BALWANI ON THURSDAY, OCTOBER 9TH, AT 5:25 P.M. OKAY.

1222

MR. WADE: AND SO IF IT'S GREENWICH MEAN TIME IN THAT PRIOR EMAIL, IT'S JUST A COUPLE HOURS AFTER HE SENT YOU THAT PRIOR EMAIL; RIGHT?

1224

MR. WADE: AND DO YOU SEE THAT HE INCLUDES A BIG GROUP OF PEOPLE ON IQP/AAP DECISIONS. DO YOU SEE THAT?

1226

MR. WADE: AND THE PLAN FORWARD?

1228

MR. WADE: OKAY. AND HE PROPOSES TO ME TUESDAY, OCTOBER 14TH?

1230

MR. WADE: OKAY. NOW, DO YOU RECALL INITIALLY -- AND HE'S SENDING YOU THIS INITIALLY, LET'S SCHEDULE A MEETING; RIGHT?

1232

MR. WADE: WITH THE TOP PEOPLE IN THE COMPANY?

1234

MR. WADE: OKAY. LET'S GO TO EXHIBIT 13923.

1235

ADAM ROSENDORFF: WHICH BINDER IS THAT IN?

1236

MR. WADE: I BELIEVE IT SHOULD BE IN THE BACK OF YOUR SECOND BINDER.

1239

ADAM ROSENDORFF: IT IS NOT THERE.

1240

MR. WADE: I'M SORRY?

1241

ADAM ROSENDORFF: IT IS NOT THERE. I'M SORRY.

1242

MS. TREFZ: THE VERY BACK.

1243

MR. WADE: MAY I APPROACH, YOUR HONOR?

1245

BY MR. WADE:

1246

MR. WADE: DO YOU HAVE 13923 IN FRONT OF YOU, DR. ROSENDORFF?

1248

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE TWO DIFFERENT CALENDAR ENTRIES RELATING TO THE IQP AAP DECISIONS AND PLAN FORWARD? DO YOU SEE THAT?

1250

MR. WADE: AND DO YOU SEE YOU'RE AN ADDRESSEE?

1252

MR. WADE: I MOVE THE ADMISSION OF 13923.

1253

MR. BOSTIC: NO OBJECTION.

1254

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

1255

(DEFENDANT'S EXHIBIT 13923 WAS RECEIVED IN EVIDENCE.)

1256

BY MR. WADE:

1257

MR. WADE: NOW, DO YOU SEE THIS IS INITIALLY SCHEDULED FOR FRIDAY, 10/10/2014? DO YOU SEE THAT?

1259

MR. WADE: AND THAT WAS THE VERY NEXT DAY AFTER THAT EMAIL WAS SENT FROM MR. BALWANI; CORRECT?

1261

MR. WADE: OKAY. AND LET'S GO TO THE NEXT PAGE. AND IT WAS RESCHEDULED SEVERAL DAYS LATER AFTER YOUR REQUEST; RIGHT?

1263

MR. WADE: AND THE ENTIRE LEADERSHIP OF THE COMPANY WAS WILLING TO MEET WITH YOU THE NEXT DAY; RIGHT?

1265

MR. WADE: AND -- BUT YOU WERE ASKING FOR IT TO BE DELAYED?

1267

MR. WADE: AND DO YOU KNOW WHY?

1268

ADAM ROSENDORFF: I DO NOT RECALL.

1269

MR. WADE: LET'S GO BACK TO 7494 NOW IF WE COULD. NOW, DO YOU SEE THE MEETING WHICH WAS MOVED TO OCTOBER 14TH, 2014? THERE WAS SOME WORK DONE IN ADVANCE OF THAT; CORRECT?

1270

ADAM ROSENDORFF: I'M AT 7494, AND I'M LOOKING AT AN EMAIL FROM DANIEL TO A BUNCH OF FOLKS.

1271

MR. WADE: AND DO YOU SEE THAT IN ADVANCE OF THAT OCTOBER 14TH MEETING, DR. YOUNG SENT A DRAFT POLICY THAT HAD PROPOSED UPDATES FOR AAP. DO YOU SEE THAT?

1273

MR. WADE: AND HE SENT THAT AROUND TO THE GROUP IN ADVANCE OF THE MEETING; CORRECT?

1275

MR. WADE: AND YOU RECEIVED THAT?

1277

MR. WADE: ALL RIGHT. NOW --

1278

ADAM ROSENDORFF: THIS POLICY REFERS TO THE ELISA ASSAYS.

1279

MR. WADE: RIGHT. AND THERE WERE, THERE WERE -- IN FACT, HE SAYS -- DO YOU SEE THE BOTTOM THERE? HE SAYS, "THIS PROTOCOL WAS WRITTEN FOR ELISA ASSAYS AND IS CURRENTLY BEING SIMILARLY EXTENDED TO CYTOMETRY AND THEN TO GC." DO YOU SEE THAT?

1281

MR. WADE: AND GC IS GENERAL CHEMISTRY?

1283

MR. WADE: AND IT'S ACTUALLY NOT DR. YOUNG'S RESPONSIBILITY TO DRAFT THE POLICY; RIGHT?

1285

MR. WADE: IT'S YOURS?

1287

MR. WADE: OKAY. BUT HE'S BEING HELPFUL HERE? HE'S SENDING LANGUAGE; RIGHT?

1289

MR. WADE: IN ADVANCE OF THE MEETING THAT YOU'RE GOING TO HAVE WITH THE SENIOR LEADERSHIP OF THE COMPANY ON THIS ISSUE; RIGHT?

1291

MR. WADE: AND, IN FACT, YOU DO HAVE THAT MEETING, DON'T YOU?

1293

MR. WADE: AND YOU HAVE THE OPPORTUNITY TO DISCUSS THIS POLICY; RIGHT?

1295

MR. WADE: AND DO YOU RECALL, I BELIEVE YOUR TESTIMONY IS IN ADDITION TO THOSE PEOPLE THAT WE TALKED ABOUT, BRAD ARINGTON WAS IN THE MEETING; RIGHT?

1296

ADAM ROSENDORFF: YES, HE WAS.

1297

MR. WADE: AND HE WAS ONE OF THE LAWYERS WHO SPECIALIZES IN REGULATORY ISSUES; RIGHT?

1299

MR. WADE: OKAY. AND WERE THERE ANY LIMITATIONS IN THAT MEETING ON YOUR ABILITY TO SAY ANYTHING OR TO DISCUSS ANYTHING?

1301

MR. WADE: OKAY. NOW JUST SO I'M CLEAR, DO YOU RECALL THAT THIS MEETING, THIS MEETING WAS THE MEETING THAT YOU DISCUSSED ON YOUR DIRECT TESTIMONY? DO YOU RECALL?

1303

MR. WADE: AND YOU DISCUSSED THE MEETING WITH ALL OF THE SENIOR LEADERSHIP IN THE COMPANY. DO YOU RECALL THAT?

1305

MR. WADE: AND IN YOUR TESTIMONY ON DIRECT EXAMINATION YOU THOUGHT IT WAS IN MID 2014; RIGHT?

1307

MR. WADE: AND DO YOU RECALL THAT?

1309

MR. WADE: AND DO YOU RECALL THEN THE GOVERNMENT ASKED, WELL, DID ANYTHING HAPPEN IN THOSE INTERVENING MONTHS BETWEEN MID 2014 AND WHEN YOU LEFT THE COMPANY? DO YOU RECALL THAT?

1311

MR. WADE: AND YOU SAID NO?

1313

MR. WADE: RIGHT? WELL, IN FACT, IT WAS IN MID-OCTOBER OF 2014, WAS IT NOT?

1314

ADAM ROSENDORFF: UNDERSTOOD. I READ THIS EMAIL, YES.

1315

MR. WADE: IS THAT CORRECT?

1317

MR. WADE: AND YOU LEFT ABOUT A MONTH LATER; RIGHT?

1319

JUDGE DAVILA: ARE YOU MOVING INTO ANOTHER AREA?

1320

MR. WADE: I'M ALMOST DONE WITH THIS LINE, YOUR HONOR. I'M CONSCIOUS OF THE TIME. AND THEN MAYBE WE CAN TAKE A BREAK.

1322

BY MR. WADE:

1323

MR. WADE: AND COMING OUT OF THAT MEETING YOU HAD SOME COMMUNICATIONS AND FOLLOWUP ON IT; CORRECT?

1324

ADAM ROSENDORFF: I BELIEVE SO.

1325

MR. WADE: OKAY. LET'S GO TO EXHIBIT 12839. I THINK IT SHOULD BE IN THE MIDDLE OF VOLUME 2?

1327

MR. WADE: AND THIS IS AN EMAIL FOLLOWING UP ON THAT CLIA LAB MEETING ON OCTOBER 15TH, 2014. DO YOU SEE THAT?

1329

MR. WADE: AND THIS IS SENT FROM -- THIS IS BETWEEN YOU AND MR. BALWANI?

1331

MR. WADE: MOVE THE ADMISSION OF 12839.

1332

MR. BOSTIC: NO OBJECTION.

1333

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

1334

(DEFENDANT'S EXHIBIT 12839 WAS RECEIVED IN EVIDENCE.)

1335

MR. WADE: LET'S GO TO THE BOTTOM AND BLOW THAT UP.

1336

MR. WADE: ON THE BOTTOM MR. BALWANI SAYS, "WE HAVE A MEETING ON OUR CALENDARS PER YOUR REQUEST." DO YOU SEE THAT?

1338

MR. WADE: AND THERE WAS ACTUALLY ANOTHER MEETING SCHEDULED FOLLOWING THAT OTHER BIG MEETING; RIGHT?

1339

ADAM ROSENDORFF: I DO NOT RECALL.

1340

MR. WADE: OKAY. CAN YOU REASONABLY INFER THAT FROM THIS STATEMENT?

1341

ADAM ROSENDORFF: I'M NOT SURE WHAT WAS GOING ON HERE.

1342

MR. WADE: HE SAYS HERE, "I THINK WE DISCUSSED THE POINTS YOU WANTED TO DISCUSS YESTERDAY OR ARE THERE OTHER POINTS YOU WANTED TO DISCUSS? IF NOT THEN CAN I REMOVE THIS FROM THE CALENDARS." DO YOU SEE THAT?

1344

MR. WADE: AND SO WHAT HE'S SAYING IS THAT YOU'VE HAD A CHANCE TO RAISE ALL OF YOUR ISSUES; IS THAT RIGHT?

1346

MR. WADE: "WE HAVE ANOTHER MEETING ON THE CALENDAR AND DO YOU WANT TO HAVE THAT MEETING AND RAISE SOME MORE ISSUES?" RIGHT? AND WHAT IS YOUR RESPONSE? DO YOU NEED TO HAVE THAT NEXT MEETING?

1347

ADAM ROSENDORFF: I SAID, "YES AGREED. THANK YOU."

1348

MR. WADE: MEANING YOU DON'T NEED TO HAVE IT; RIGHT?

1350

MR. WADE: LET'S GO TO 2099.

1352

MR. WADE: AND DO YOU SEE THAT? AND DO YOU SEE THIS IS AN EMAIL BETWEEN YOU, MR. ARINGTON, AND DR. YOUNG ON OCTOBER 16TH, 2014?

1354

MR. WADE: AND THIS REFERS TO PROFICIENCY TESTING AND AAP; CORRECT?

1356

MR. WADE: AND MOVE THE ADMISSION OF EXHIBIT 2099?

1357

MR. BOSTIC: NO OBJECTION.

1358

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

1359

(GOVERNMENT'S EXHIBIT 2099 WAS RECEIVED IN EVIDENCE.)

1360

BY MR. WADE:

1361

MR. WADE: NOW, THIS IS THE DAY AFTER THE MEETING WITH THE MR. ARINGTON AND THE SENIOR LEADERSHIP; CORRECT?

1363

MR. WADE: AND YOU'RE FOLLOWING UP ON THAT MEETING; CORRECT?

1365

MR. WADE: AND YOU SAY IN HERE AND YOU GIVE SOME DIRECTION ON WHAT NEEDS TO BE DONE WITH CMS AND YOU, YOU SET FORTH -- IT SAYS AT THE TOP, "I WOULD LIKE TO DE-ENROLL IN CMS REPORTING FOR THE FOLLOWING ANALYTES BASED ON THE FACT THAT THEY ARE NO LONGER RUN ON METHODS FOR WHICH THERE IS A PEER-GROUP." DO YOU SEE THAT?

1367

MR. WADE: THE LDT'S; RIGHT?

1369

MR. WADE: AND THIS IS YOUR DECISION TO MAKE AS THE LAB DIRECTOR; RIGHT?

1371

MR. WADE: AND SO THE DECISION THAT YOU'RE MAKING HERE IS TO SWITCH FROM THE OLD BIG MACHINE TEST FOR PURPOSES OF PROFICIENCY TESTING TO AAP FOR THE EDISON DEVICES; CORRECT?

1372

ADAM ROSENDORFF: I BELIEVE WHAT I SAID WAS THAT WE SHOULD STILL RUN PROFICIENCY ON THE LARGER INSTRUMENTS BUT NOT REPORT IT BECAUSE IT'S NO LONGER OUR PRIMARY METHOD.

1373

MR. WADE: RIGHT. SO YOU'RE SAYING FOR OFFICIAL CLIA COMPLIANCE PURPOSES --

1375

MR. WADE: -- YOU ARE DIRECTING HERE ON OCTOBER 16TH --

1377

MR. WADE: -- THAT YOU WANT THE EDISON AAP TO BE WHAT IS USED FOR THE ANALYTES; RIGHT?

1379

MR. WADE: THAT'S YOUR DIRECTION?

1381

MR. WADE: BECAUSE THAT'S YOUR JUDGMENT UNDER THOSE REGULATIONS, RIGHT, SIR?

1383

MR. WADE: OKAY. BUT YOU'RE STILL GOING TO DO THE PROFICIENCY TESTING ON THE OTHER METHOD EVEN THOUGH YOU'RE NOT REQUIRED TO DO IT; RIGHT?

1385

MR. WADE: BECAUSE THAT'S GOOD PRACTICE?

1387

MR. WADE: AND YOU'RE SETTING FORTH WHAT NEEDS TO BE DONE IN OCTOBER 16TH, 2014?

1389

MR. WADE: THE DAY AFTER THAT MEETING WITH, WITH THE LEADERSHIP OF THE COMPANY; CORRECT?

1391

MR. WADE: AND NOW LET ME GO BACK TO 12846. LET'S BLOW THIS UP. IT'S AT THE BOTTOM. IT'S UP ON THE SCREEN. THIS IS THE ONLY THING I'M GOING TO ASK IF YOU WANT TO READ IT THERE. DO YOU SEE IT?

1393

MR. WADE: THIS IS OCTOBER 17TH, 2014; CORRECT?

1395

MR. WADE: AND THIS IS TWO DAYS AFTER THE MEETING WITH SENIOR LEADERSHIP; CORRECT?

1397

MR. WADE: AND IT'S ONE DAY AFTER YOUR MEETING WITH MR. ARINGTON; CORRECT?

1399

MR. WADE: AND THIS IS WHERE YOU TALK ABOUT THE AAP THAT WAS PERFORMED ON APRIL 18TH, 2014; CORRECT?

1401

MR. WADE: THIS WOULD BE A GOOD PLACE TO BREAK, YOUR HONOR.

1402

JUDGE DAVILA: ALL RIGHT. LET'S TAKE OUR MORNING RECESS, LADIES AND GENTLEMEN. LET'S TAKE 20 MINUTES, PLEASE, 20 MINUTES, AND WE'LL BE BACK TO FINISH OUR SESSION. THANK YOU.

1403

(RECESS FROM 11:08 A.M. UNTIL 11:37 A.M.)

1404

JUDGE DAVILA: WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. WOULD YOU LIKE TO CONTINUE?

1405

MR. WADE: I WOULD, YOUR HONOR. THANK YOU.

1407

BY MR. WADE:

1408

MR. WADE: DR. ROSENDORFF, I'D LIKE TO SWITCH TOPICS AND ASK YOU SOME QUESTIONS ABOUT HCG.

1410

MR. WADE: OKAY. IF WE COULD START BY PULLING UP EXHIBIT 4836. AND IF WE CAN GO TO THE THIRD PAGE AND FOCUS ON THE EMAIL AT THE TOP THERE. OKAY. DO YOU RECALL YOU WERE ASKED SOME QUESTIONS ABOUT THIS IN YOUR DIRECT EXAMINATION?

1412

MR. WADE: THIS WAS AN OCTOBER 2013 EMAIL THAT RELATED TO HCG PRECISION?

1414

MR. WADE: AND THE GOVERNMENT ASKED YOU ABOUT HOW THE HCG PROCESS -- WHAT HCG IS AND ITS IMPORTANCE IN PREGNANCY. DO YOU RECALL THAT?

1416

MR. WADE: AND IN PARTICULAR THEY FOCUSSED ON THIS PIECE OF THE EVIDENCE. DO YOU SEE THAT? THIS EMAIL WHERE IT TALKS ABOUT TOTAL ALLOWABLE ERROR. DO YOU SEE THAT?

1418

MR. WADE: AND THE PRECISION EFFECTS THAT WERE RELEVANT IN THE DATA THAT WAS COMING BACK. DO YOU SEE THAT?

1420

MR. WADE: AND THEY ASKED YOU A NUMBER OF QUESTIONS ABOUT HOW IF YOU RELAXED THE PERCENTAGE OF TOTAL ALLOWABLE ERROR, THAT THAT WOULD MAKE THE TEST LESS ACCURATE; RIGHT? DO YOU RECALL THAT?

1422

MR. WADE: AND THAT THAT -- MAYBE THEY ASKED IF IT'S A GOOD THING OR A BAD THING. AND IT'S A BAD THING; RIGHT?

1424

MR. WADE: AND THEY NEXT BROUGHT YOU TO -- IF WE CAN GO TO THE EMAIL ON THE SECOND PAGE IN THE MIDDLE. THEY BROUGHT YOU TO THIS EMAIL. DO YOU UNDERSTAND THAT?

1426

MR. WADE: AND THEY TALKED ABOUT YOUR CONCERNS WITH RELAXING TOTAL ALLOWABLE ERROR; RIGHT?

1428

MR. WADE: BECAUSE IT WOULD MAKE THAT A LOT MORE ACCURATE. DO YOU RECALL? INACCURATE?

1430

MR. WADE: OKAY. AND THEY THEN ASKED YOU WHETHER YOU GENERALLY RECALL HCG ISSUES AT THE COMPANY WITH RESPECT TO ACCURACY; RIGHT?

1432

MR. WADE: OKAY. AND THEN I DON'T KNOW IF YOU RECALL, BUT THEY JUMPED FROM OCTOBER 30TH TO AN EMAIL LATER IN 2014; RIGHT?

1433

ADAM ROSENDORFF: I DON'T RECALL.

1434

MR. WADE: OKAY. I WANT TO STAY WITH THIS OCTOBER 30TH EMAIL. OKAY?

1436

MR. WADE: AND I WANT TO CLARIFY THAT. OKAY?

1438

MR. WADE: THIS IS AN EMAIL -- LET'S START WITH SOME DATES THAT ARE RELEVANT HERE. THIS IS AN EMAIL ON OCTOBER 30TH, 2013; CORRECT?

1440

MR. WADE: AND DO YOU RECALL FROM OUR EXERCISE YESTERDAY THE DATE ON WHICH HCG WAS VALIDATED FOR USE IN THE CLIA LAB?

1441

ADAM ROSENDORFF: I DON'T RECALL THE DATE.

1442

MR. WADE: OKAY. WE'LL GO TO THAT IN A SECOND. THIS IS AN EMAIL WITH DR. SIVARAMAN; RIGHT?

1444

MR. WADE: AND DO YOU SEE THAT? AND DR. SIVARAMAN WAS IN CHARGE IN THIS PERIOD OF THE RESEARCH AND DEVELOPMENT, RIGHT, FOR ELISA ASSAYS?

1446

MR. WADE: AND SHE IS COMING TO YOU, ALONG WITH DR. YOUNG, TO SEEK YOUR GUIDANCE ON THE STANDARDS THAT SHOULD BE USED FOR VALIDATION; RIGHT?

1448

MR. WADE: AND THEY'RE SAYING TO YOU, BECAUSE YOU'RE THE EXPERT ON THESE ISSUES, RIGHT, THEY'RE ASKING YOU WHAT IS PERMISSIBLE HERE; RIGHT?

1450

MR. WADE: AND THEY'RE TRYING TO GET YOUR GUIDANCE ON THIS EMAIL; CORRECT?

1452

MR. WADE: AND THAT'S WHAT YOU'RE PROVIDING; RIGHT?

1454

MR. WADE: OKAY. AND LET'S LOOK AT THE VALIDATION REPORT. WE'LL JUST BRING IT UP. WE ONLY NEED THE DATE. IT'S EXHIBIT 9196. LET'S JUST BLOW UP THE DATE. DO YOU SEE THE HCG VALIDATION REPORT THAT YOU SIGNED FOR USE OF THIS ASSAY IN THE CLIA LAB WAS MARCH 19TH, 2014; CORRECT?

1456

MR. WADE: OKAY. LET'S BRING UP THAT CALENDAR DEMONSTRATIVE IF WE CAN. SO THE CIRCLE THAT I JUST PUT ON THE SCREEN WAS THE CONCERN THAT WAS EXPRESSED; RIGHT? THAT WAS THIS ISSUE THAT THE GOVERNMENT ASKED YOU ABOUT OR 4836; RIGHT?

1457

ADAM ROSENDORFF: ARE YOU TALKING ABOUT KARTHIK ASKING ME TO RELAX THE TOTAL ALLOWABLE ERROR?

1458

MR. WADE: YEAH, WHEN THEY MADE THAT INQUIRY.

1460

MR. WADE: IT'S ON THAT DATE; RIGHT?

1462

MR. WADE: AND THE VALIDATION REPORT IS RIGHT HERE; RIGHT?

1464

MR. WADE: IT'S ON MARCH 19TH?

1466

MR. WADE: AND IN ALL OF THOSE INTERVENING MONTHS IN BETWEEN THERE, THERE WERE NO HCG EDISON ASSAYS THAT WERE USED IN CLIA LAB; CORRECT?

1468

MR. WADE: OKAY. AND IF THEY WERE WORKING IN R&D TO GET THAT ASSAY IN A PLACE WHERE IT WAS APPROPRIATE FOR USE IN THE CLIA LAB, WAS IT APPROPRIATE FOR THEM TO COME TO YOU AND SEEK GUIDANCE ON TOTAL ALLOWABLE ERROR ISSUES?

1470

MR. WADE: AND WAS IT, IN FACT, EVEN REALLY ADVISABLE FOR THEM TO GO AND DO THAT?

1472

MR. WADE: OKAY. NOW, WE CAN TAKE THAT DOWN, MR. BENNETT. THANK YOU. COULD YOU WIPE THIS SCREEN, MS. KRATZMANN.

1473

COURT CLERK: YES.

1474

MR. WADE: THANK YOU.

1475

MR. WADE: NOW, I WANT TO GO TO SOME OF THE, I WANT TO GO TO SOME OF THE ISSUES WITH HCG THAT CAME UP IN 2014. OKAY?

1477

MR. WADE: AND DO YOU RECALL THERE WAS SOME TESTIMONY THAT YOU HAD ABOUT A DISCUSSION THAT YOU HAD WITH MS. HOLMES WHERE YOU WERE FREAKING OUT; RIGHT?

1479

MR. WADE: AND I BELIEVE IT WAS YOUR TESTIMONY THAT SHE WAS KIND OF INDIFFERENT; RIGHT?

1481

MR. WADE: AND YOU STAND BY THAT TESTIMONY TODAY?

1482

ADAM ROSENDORFF: I DID NOT USE THE WORD "INDIFFERENT." SHE SEEMED PRETTY CALM ABOUT THE WHOLE THING. SHE DIDN'T SEEM TO SHARE MY LEVEL OF ALARM.

1483

MR. WADE: AND URGENCY?

1485

MR. WADE: OKAY. LET'S LOOK BRIEFLY AT EXHIBIT 4222, WHICH IS IN EVIDENCE. THIS IS A DOCUMENT THAT YOU'RE NOT ON, BUT YOU WERE SHOWED THIS DOCUMENT THE OTHER DAY. IF WE CAN LOOK AT -- DO YOU SEE IN THE EMAIL DOWN THERE IT MENTIONS AN HCG ISSUE THAT COMES UP? DO YOU SEE THAT? IT JUST IDENTIFIES THAT THERE'S AN HCG --

1487

MR. WADE: OKAY. LET'S GO UP THE CHAIN AND BLOW UP THE THREE EMAILS AT THE TOP. AND DO YOU SEE THAT THAT HCG ISSUE IS COMMUNICATED FROM MR. BALWANI TO MS. HOLMES AT 4:45 P.M. DO YOU SEE THAT?

1489

MR. WADE: DO YOU SEE THAT RIGHT HERE (INDICATING)?

1491

MR. WADE: OKAY. AND DO YOU SEE THAT SHE RESPONDS SIX MINUTES LATER?

1493

MR. WADE: ASKING "HOW DID THAT HAPPEN?"

1495

MR. WADE: OKAY. I'M DONE WITH THAT EXHIBIT. IF WE CAN BRING UP EXHIBIT 4145, WHICH IS IN EVIDENCE. AND IF WE CAN FOCUS UP AT THE TOP. DO YOU RECALL -- YOU'RE WELCOME TO LOOK AT THE WHOLE DOCUMENT, TOO. BUT DO YOU RECALL THAT THIS WAS AN EMAIL THAT WAS FORWARDED FROM MR. BALWANI TO MS. HOLMES AND SHE RESPONDED THAT, "I'VE DONE MANY MEETINGS ON THIS TODAY"? DO YOU RECALL THIS?

1497

MR. WADE: AND DO YOU RECALL THAT YOU WERE ASKED WHETHER THE GOVERNMENT -- BY THE GOVERNMENT WHETHER YOU WERE IN ANY OF THOSE MEETINGS AND YOU SAID YOU WERE NOT? DO YOU RECALL THAT?

1499

MR. WADE: OKAY. I'D LIKE TO GO THROUGH THE TIMELINE HERE AND PUT THE FACTS OUT. OKAY? AND I HAVE A DEMONSTRATIVE THAT I'M GOING TO USE TO DO THAT. OKAY? THIS IS SOMETHING THAT I WOULD NORMALLY DO ON LIKE A PIECE OF PAPER OR FLIP CHART, BUT WITH OUR CURRENT LOGISTICAL SITUATION IT'S A LITTLE DIFFICULT SO I'M GOING TO TRY TO DO IT ELECTRONICALLY. OKAY?

1501

MR. WADE: LET'S GO BACK TO 4145. LET'S BRING UP 4145 AND GO TO THE LAST EMAIL IN 4145. LET'S START THERE. DO YOU SEE THAT AT 1:56 P.M. ON MAY 29TH, 2014 THERE WAS AN ISSUE THAT WAS RAISED WITH RESPECT TO HCG?

1503

MR. WADE: AND DO YOU SEE THE INDICATION THAT THE RESULTS ARE BEING HELD UNTIL FURTHER NOTICE RIGHT THERE. DO YOU SEE THAT?

1505

MR. WADE: IF WE CAN DO A SPLIT SCREEN WHERE WE PULL UP THE GRAPHIC AND JUST PUT THAT DATE UP. ANY OBJECTION TO THE FIRST ENTRY THERE?

1506

MR. BOSTIC: NO OBJECTION.

1507

BY MR. WADE:

1508

MR. WADE: SO THIS IS THURSDAY, MAY 29TH, 2014, IN THE FIRST ENTRY. AND LET'S GO NEXT. ON THE TIMELINE LET'S PUT UP WHAT WE JUST TALKED ABOUT WITH DR. ROSENDORFF, THE CUSTOMER SERVICE EMAILS. DO YOU SEE THAT?

1510

MR. WADE: AND LET'S WORK UP THE CHAIN AND LET'S WORK UP TO 2:56 P.M. YOU'RE NOT ON THIS EMAIL, BUT THIS IS AN EMAIL FROM DR. YOUNG TO MR. BALWANI. DO YOU SEE THAT?

1512

MR. WADE: AND DO YOU SEE ON THE BOTTOM -- AND IT'S AT 2:56 P.M. DO YOU SEE THAT?

1514

MR. WADE: AND IT SAYS, "I ASKED ADAM TO CALL THE DOCTOR TO ASK ABOUT THE CLINICAL SITUATION." AND IT SAYS, "AND THEN WE WILL BE ABLE TO DECIDE IF WE WANT TO RELEASE THE RESULTS." RIGHT?

1516

MR. WADE: AND THAT WAS APPROPRIATE; CORRECT?

1518

MR. WADE: AND YOU WERE THE ONE WHO WAS SUPPOSED TO COMMUNICATE AND REACH OUT TO THE DOCTOR?

1520

MR. WADE: AND ONE OF YOUR DOTTED LINE BOSSES, DR. YOUNG, IS REPORTING TO ANOTHER BOSS ABOUT WHAT IS HAPPENING ON THAT. DO YOU SEE THAT?

1522

MR. WADE: OKAY. LET'S ADD THAT ITEM TO OUR TIMELINE. OKAY?

1524

MR. WADE: AND THEN THE NEXT ENTRY, THE NEXT EMAIL UP THE CHAIN MR. BALWANI SAYS TO KEEP HIM IN THE LOOP. OKAY?

1526

MR. WADE: "I ASSUME THIS WAS RUN ON EDISONS?"

1528

MR. WADE: AND THEN LET'S WORK OUR WAY UP THE CHAIN THERE TO OUR NEXT EMAIL. AND THIS IS A REPORT FROM DR. YOUNG WHERE IT SAYS, "WE SPOKE WITH THE ORDERING PHYSICIAN, AND MADE THE DECISION TO COLLECT ANOTHER SAMPLE. WE ARE NOT REPORTING OUT THE VERY LOW RESULT." DO YOU SEE THAT?

1530

MR. WADE: AND THAT WAS YOU WHO SPOKE TO THAT PHYSICIAN; CORRECT?

1531

ADAM ROSENDORFF: I DO NOT RECALL.

1532

MR. WADE: OKAY. BUT YOU SAW THE EMAIL BELOW WHERE YOU WERE THE ONE WHO WAS GOING TO BE CALLING THE PHYSICIAN? DO YOU RECALL THAT?

1533

ADAM ROSENDORFF: DANIEL SAYING THAT HE ASKED ME TO CALL, YES.

1534

MR. WADE: OKAY. AND THEN AT THIS TIME AT 5:37 IT'S BEING REPORTED THAT THAT COMMUNICATION HAD HAPPENED, THAT THE RESULTS ARE BEING HELD AND A NEW RESULT IS HAPPENING. DO YOU SEE THAT?

1535

ADAM ROSENDORFF: THE DECISION WAS MADE TO COLLECT ANOTHER SAMPLE, RIGHT.

1537

ADAM ROSENDORFF: NOT JUST A NEW RESULT.

1538

MR. WADE: ANOTHER SAMPLE SO YOU COULD RERUN IT; CORRECT?

1540

MR. WADE: A REDRAW. IS THAT CALLED A REDRAW?

1542

MR. WADE: OKAY. LET'S PUT THAT ITEM UP ON THE TIMELINE, THE DEMONSTRATIVE. OKAY. NOW LET'S GO UP TO THE TOP EMAILS. OKAY. AND THIS IS THE ONE WHERE MS. HOLMES SAYS SHE'S BEEN IN MANY MEETINGS ON THIS. BUT YOU WEREN'T IN ANY OF THE MEETINGS WITH HER; IS THAT RIGHT?

1543

ADAM ROSENDORFF: I DON'T RECALL BEING IN ANY MEETINGS WITH HER.

1544

MR. WADE: I BELIEVE YOU TESTIFIED THAT YOU WERE NOT IN ANY MEETINGS; IS THAT RIGHT?

1545

ADAM ROSENDORFF: I DON'T BELIEVE I WAS IN ANY MEETINGS WITH HER.

1546

MR. WADE: OKAY. WELL, LET'S TAKE A LOOK. LET'S ADD THAT ITEM TO THE CHRONOLOGY. IF I DID A TIMELINE CALCULATION, THE INTERNET HAS IT -- AND IF THAT IS GREENWICH MEAN TIME THAT WOULD PUT THAT AT 6:20 P.M. OKAY?

1548

MR. WADE: AND SO LET'S ADD THAT TO OUR TIMELINE. DO YOU SEE IT OVER THERE?

1550

MR. WADE: NOW, LET'S GO TO EXHIBIT 13862. OR ACTUALLY, IT MIGHT BE EASIER TO SEE IT EASIER, I'M GOING TO GO TO 13862, 13863, 64, AND -- 62, 63, AND 64. OKAY. THEY'RE RIGHT NEXT TO EACH OTHER. GO AHEAD AND GRAB THOSE, DOCTOR. OKAY. LET ME DRAW YOUR ATTENTION FIRST TO 13863.

1552

MR. WADE: DO YOU SEE THAT?

1554

MR. WADE: AND DO YOU SEE THAT'S AN OUTLOOK CALENDAR?

1556

MR. WADE: AND DO YOU RECOGNIZE THAT AS MS. HOLMES'S OUTLOOK CALENDAR?

1558

MR. WADE: OKAY. I MOVE THE ADMISSION OF 13863.

1559

MR. BOSTIC: OBJECTION TO FOUNDATION AND AUTHENTICITY.

1560

JUDGE DAVILA: MAYBE YOU SHOULD LAY A FOUNDATION.

1561

MR. WADE: I ASKED THAT THIS CONDITIONALLY BE SUBMITTED. I BELIEVE WE STIPULATED TO THE AUTHENTICITY OF THE UNDERLYING DATA.

1562

JUDGE DAVILA: MR. BOSTIC --

1563

MR. WADE: IF NOT, WE CERTAINLY CAN WITH OUR PWC FRIEND.

1564

MR. BOSTIC: YOUR HONOR, ESPECIALLY ON FOUNDATION, ONE NEEDS TO BE LAID.

1565

JUDGE DAVILA: CAN YOU LAY A FOUNDATION?

1566

MR. WADE: THROUGH THIS WITNESS?

1568

MR. WADE: I DON'T KNOW. WE CAN CALL HIM BACK AND THAT'S WHY I ASK THAT IT BE --

1569

JUDGE DAVILA: CAN YOU LAY A FOUNDATION WITH THIS WITNESS OR YOU THINK NOT?

1570

MR. WADE: I DON'T THINK I CAN LAY A FOUNDATION WITH THIS WITNESS. SO I WOULD ASK UNDER 104 THAT THIS BE CONDITIONALLY SUBMITTED. I WILL REPRESENT TO THE COURT THAT I CAN EASILY LAY A FOUNDATION FOR THIS DOCUMENT.

1571

JUDGE DAVILA: ALL RIGHT. THIS IS 13863?

1573

JUDGE DAVILA: ALL RIGHT. THIS WILL BE CONDITIONALLY ADMITTED SUBJECT TO MOTION TO STRIKE FOR LACK OF A FOUNDATION.

1574

MR. WADE: THANK YOU, YOUR HONOR.

1575

JUDGE DAVILA: IT WILL BE ADMITTED CONDITIONALLY.

1576

MR. WADE: CAN WE PUBLISH, YOUR HONOR?

1578

(DEFENDANT'S EXHIBIT 13863 WAS CONDITIONALLY RECEIVED IN EVIDENCE.)

1579

BY MR. WADE:

1580

MR. WADE: LET'S BLOW UP THE MIDDLE. THIS IS MAY 29TH, 2014. DO YOU SEE THAT?

1582

MR. WADE: AND DO YOU SEE THERE IT SAYS MEETING WITH ADAM ROSENDORFF AT 3:00 O'CLOCK?

1584

MR. WADE: AND DO YOU SEE THERE'S A MEETING WITH DANIEL YOUNG AS WELL?

1587

ADAM ROSENDORFF: A NUMBER OF THOSE ARE OVERLAPPING MEETINGS. I DON'T RECALL MEETING WITH MS. YOUNG ON THIS ISSUE. I'M SORRY, I DON'T RECALL MEETING WITH MS. HOLMES ON THIS ISSUE.

1588

MR. WADE: I BELIEVE YOUR TESTIMONY WAS THAT YOU DID NOT MEET WITH MS. HOLMES; IS THAT CORRECT?

1590

MR. WADE: THAT WAS YOUR TESTIMONY ON DIRECT; RIGHT?

1591

ADAM ROSENDORFF: I BELIEVE SO.

1592

MR. WADE: OKAY. DID THE GOVERNMENT SHOW YOU THE CALENDAR ENTRIES?

1594

MR. WADE: OKAY. LET'S GO TO 13862, WHICH I WOULD ASK TO BE CONDITIONALLY ADMITTED UNDER THE SAME REPRESENTATION AND THE SAME CONDITIONS, YOUR HONOR. IT'S JUST A DIFFERENT FORMAT OF THE SAME DATA.

colloquycolloquyAdmissibility Colloquy Regarding Defense Exhibit 13862
1595

JUDGE DAVILA: RIGHT. ARE YOU ASKING -- THERE'S SOME WRITING ON THIS DATA. ARE YOU ASKING THAT THAT BE ADMITTED ALSO?

1596

MR. WADE: I AM. I ONLY INTEND TO DRAW THE WITNESS'S ATTENTION TO ONE SMALL PIECE OF IT, BUT IF THE GOVERNMENT WOULD LIKE IT REDACTED, I'M HAPPY TO.

1597

MR. BOSTIC: SAME OBJECTIONS AS BEFORE, YOUR HONOR. THERE ARE ALSO HEARSAY ISSUES WITH THIS DOCUMENT.

1598

JUDGE DAVILA: WHAT -- CAN YOU REDACT THAT PORTION OR LET THE GOVERNMENT KNOW WHAT PORTION THAT YOU'RE GOING TO SPEAK TO?

1599

MR. WADE: SURE. MY SENSE IS THAT THEY HAVE AN IDEA.

1600

MR. BOSTIC: SAME OBJECTIONS, YOUR HONOR, FOUNDATION, AUTHENTICITY, AND HEARSAY.

1601

JUDGE DAVILA: ALL RIGHT. AS TO THE HEARSAY OBJECTION, THAT IS WHY I AM CURIOUS AS TO WHICH PORTION --

1602

MR. WADE: I WOULD OFFER IT JUST FOR THE STATE OF MIND OF MS. HOLMES.

1603

JUDGE DAVILA: OKAY. SO I SHOULD KNOW WHAT IT IS THAT YOU'RE SEEKING.

1604

MR. WADE: IT IS ONLY THE PORTION UNDER 4:00 O'CLOCK, THE TWO ITEMS, ONE AT 4:00 O'CLOCK TO 4:20 AND ONE FROM 4:25 TO 4:30 ON PAGE 415.

1605

JUDGE DAVILA: AND THOSE ARE -- I SEE THOSE ITEMS ON THE CALENDAR. THOSE ARE REFERENCING IN THE WRITTEN MATERIALS AS WELL?

1606

MR. WADE: THESE ARE THE OTHER ITEMS I'M GOING TO REFERENCE, YOUR HONOR, OTHER THAN THE DATE ITSELF.

1607

(PAUSE IN PROCEEDINGS.)

1608

JUDGE DAVILA: I'M SORRY. ARE YOU SEEKING TO INTRODUCE ANY OF THE WRITINGS?

1610

JUDGE DAVILA: JUST WHAT YOU HAVE HIGHLIGHTED?

1611

MR. WADE: YES, AND THE DATE.

1612

JUDGE DAVILA: CORRECT. GOTCHA. OKAY. THOSE WILL BE CONDITIONALLY ADMITTED SUBJECT TO A MOTION TO STRIKE FOR LACK OF FOUNDATION. NONE OF THE WRITTEN MATERIAL IS GOING TO BE OFFERED.

1613

MR. WADE: THANK YOU, YOUR HONOR. MAY WE PUBLISH?

1615

(DEFENDANT'S EXHIBIT 13862 WAS CONDITIONALLY RECEIVED IN EVIDENCE.)

1616

BY MR. WADE:

Cross 2Cross 2 Adam Rosendorff Lance A. Wade
1617

MR. WADE: DO YOU SEE THERE AN ENTRY ON THE CALENDAR FOR A MEETING WITH YOU FOLLOWED IMMEDIATELY BY A MEETING WITH DR. YOUNG?

1619

MR. WADE: AND DO YOU SEE THE TOPICS DISCUSSED HCG PATIENT DATA?

1620

ADAM ROSENDORFF: WITH DR. YOUNG, YES.

1621

MR. WADE: DO YOU SEE THAT?

1623

MR. WADE: OKAY. LET'S GO BACK TO THE DEMONSTRATIVE, AND LET'S ADD THOSE ITEMS. LET'S GO TO DOCUMENT 13864. DO YOU SEE THAT?

1625

MR. WADE: AND THAT'S AN EMAIL MEETING, EMAIL YOU RECEIVED FROM MS. HOLMES'S ASSISTANT ON MAY 30TH, 2014? DO YOU SEE THAT?

1627

MR. WADE: I MOVE THE ADMISSION OF 13864.

1628

MR. BOSTIC: NO OBJECTION.

1629

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

1630

(DEFENDANT'S EXHIBIT 13864 WAS RECEIVED IN EVIDENCE.)

1631

MR. WADE: LET'S GO THAT UP.

1632

MR. WADE: THIS IS THE NEXT DAY, CORRECT, SIR?

1634

MR. WADE: AND DO YOU SEE THAT MS. HOLMES'S ASSISTANT FOLLOWS UP THE NEXT DAY AND ASKED YOU TO COORDINATE ANOTHER CLIA MEETING THAT AFTERNOON AT 4:00 P.M. DO YOU SEE THAT?

1636

MR. WADE: AND ASKS YOU TO GIVE A LIST OF ATTENDEES FOR THAT SESSION?

1638

MR. WADE: DO YOU SEE THAT?

1640

MR. WADE: AND UP AT THE TOP IT SAYS 10:34 P.M. THAT IS GREENWICH MEAN TIME, 3:30 P.M. PACIFIC, WHICH GIVEN THAT THEY'RE SUGGESTING A 4:00 P.M. MEETING. WOULD THAT SEEM LIKE THAT WAS THE ONLY REASONABLE TIMING INFERENCE?

1641

ADAM ROSENDORFF: YEAH, THAT'S PRETTY SHORT NOTICE TO BE SETTING UP A MEETING.

1642

MR. WADE: IT WAS AN URGENT MEETING; RIGHT?

1643

ADAM ROSENDORFF: I DON'T KNOW WHAT MS. HOLMES INTENDED TO DISCUSS IN THAT MEETING.

1644

MR. WADE: OKAY. YOU DON'T RECALL THE SUBSTANCE OF THAT MEETING?

1646

MR. WADE: OKAY. LET'S ADD THAT TO THE TIMELINE. LET'S GO NEXT TO EXHIBIT 4147.

1648

MR. WADE: OKAY. AND DO YOU SEE THIS EMAIL?

1650

MR. WADE: AND THIS IS THE EMAIL WHERE YOU STOPPED THE HCG TESTING AND DIRECTED THAT THAT NOT OCCUR; RIGHT?

1651

ADAM ROSENDORFF: I DIRECTED FOR THE TESTING TO BE RUN ON THE IMMULITE.

1652

MR. WADE: RIGHT. AND FOR THE EDISON HCG TESTING TO BE HELD; RIGHT?

1654

MR. WADE: OKAY. AND THAT'S AT 7:52 ON THAT FRIDAY, MAY 30TH; CORRECT?

1656

MR. WADE: AND THAT'S JUST A COUPLE OF HOURS AFTER 4:00 O'CLOCK ON THAT FRIDAY, IS IT NOT?

1657

ADAM ROSENDORFF: IS THIS STILL GREENWICH MEAN TIME? I DON'T KNOW. IS THIS PACIFIC OR?

1658

MR. WADE: I DON'T KNOW. USUALLY IT'S THE TOP EMAIL THAT ADJUSTS, BUT DO YOU RECALL WHEN YOU SENT THIS EMAIL?

1659

ADAM ROSENDORFF: DO I HAVE AN INDEPENDENT RECOLLECTION IF I SENT THIS EMAIL FROM SEVEN YEARS AGO?

1661

ADAM ROSENDORFF: NO, I DO NOT.

1662

MR. WADE: I WOULD BE SURPRISED IF YOU DID. IN FACT, YOU DON'T EVEN REMEMBER HAVING A MEETING OR INTERACTING WITH MS. HOLMES ON THIS HCG DURING THIS TIME PERIOD, DO YOU?

1663

ADAM ROSENDORFF: I CAN'T ANSWER YES OR NO.

1664

MR. WADE: OKAY. LET'S GO TO THE NEXT. WELL, YOU DON'T RECALL THE MEETING; RIGHT? THAT WAS YOUR TESTIMONY ON DIRECT?

1666

MR. WADE: AND THE FACT THAT THIS HAS HAPPENED IS REPORTED UP, DO YOU SEE THAT, TO MS. HOLMES?

1668

MR. WADE: SO SHE IS AWARE THAT THAT TEST HAD BEEN HELD?

1670

MR. WADE: A FEW HOURS AFTER THAT 4:00 O'CLOCK MEETING?

1671

ADAM ROSENDORFF: IT LOOKS LIKE IT WAS THE NEXT DAY, YEAH. THIS IS SATURDAY NOW THAT MR. BALWANI IS EMAILING MS. HOLMES ABOUT THIS ISSUE.

1672

MR. WADE: RIGHT. BUT IT WAS PULLED -- THE TEST WAS PULLED, IF WE GO BACK TO THE OTHER EMAIL, JUST A FEW HOURS AFTER THAT 4:00 O'CLOCK MEETING?

1673

ADAM ROSENDORFF: IT LOOKS LIKE IT, CORRECT.

1674

MR. WADE: LET'S GO BACK TO THE DEMONSTRATIVE. LET'S ADD THAT. I HAVE TO ASK YOU, SIR, DO YOU STAND BY YOUR TESTIMONY THAT YOU DID NOT MEET WITH MS. HOLMES ON THESE HCG ISSUES DURING THIS TIME PERIOD?

1676

MR. WADE: YOU DO?

1679

ADAM ROSENDORFF: I RECALL -- I'M SORRY.

1680

MR. WADE: I'D LIKE TO TALK MORE ABOUT 4147. DO YOU SEE THAT? THIS IS THE EMAIL WHERE YOU STOPPED THE TESTING. DO YOU RECALL THAT?

1682

MR. WADE: OKAY. AND DO YOU RECALL THAT THE GOVERNMENT ASKED YOU ABOUT A COUPLE OF OTHER EXHIBITS WHERE THEY SHOWED TESTING THAT HAPPENED LATER IN TIME?

1684

MR. WADE: AND THEY ASKED YOU, THEY ASKED YOU IF YOU WERE AWARE THAT TESTING HAD, ON THE EDISON DEVICE FOR HCG, HAD BEEN RE-IMPLEMENTED?

1686

MR. WADE: AND YOU SAID YOU WERE NOT AWARE OF THAT?

1687

ADAM ROSENDORFF: I WAS NOT AWARE.

1688

MR. WADE: YOU WERE NOT AWARE OF THAT. AND YOU SAID -- THE SUGGESTION WAS THAT YOU WERE BEING COUNTERMANDED; RIGHT?

1689

ADAM ROSENDORFF: I DON'T KNOW WHAT THE SUGGESTION WAS. I'M JUST TESTIFYING THAT I WAS NOT AWARE.

1690

MR. WADE: YOU WERE NOT AWARE THAT THE HCG TEST WAS GOING -- EVER WENT BACK ON THE EDISON DEVICE?

1692

MR. WADE: OKAY. LET'S LOOK AT SOME DOCUMENTS. LET'S GO TO 12656. THIS IS AN EMAIL BETWEEN YOU AND AT DIFFERENT TIMES MR. BALWANI AND DR. YOUNG AND DR. PANGARKAR; CORRECT?

1694

MR. WADE: AND IT'S DATED JUNE 4TH, 2014; CORRECT?

1696

MR. WADE: AND JUST A FEW DAYS AFTER THESE EVENTS THAT WE'VE BEEN TALKING ABOUT?

1698

MR. WADE: OKAY. MOVE TO ADMIT 12656.

1699

MR. BOSTIC: NO OBJECTION.

1700

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

1701

(DEFENDANT'S EXHIBIT 12656 WAS RECEIVED IN EVIDENCE.)

1702

BY MR. WADE:

1703

MR. WADE: LET'S START WITH THE BOTTOM EMAIL. DO YOU SEE THIS IS AN EMAIL FROM DR. BALWANI -- OR MR. BALWANI TO DR. YOUNG AND DR. PANGARKAR?

1705

MR. WADE: AND IT SAYS THAT YOU CAME BACK EXTREMELY FRUSTRATED THAT AS LAB DIRECTOR THAT YOU'RE NOT BEING KEPT IN THE LOOP WITH RESPECT TO CERTAIN CLIA R&D EXPERIMENTS. DO YOU RECALL THAT?

1707

MR. WADE: AND THAT YOU WERE FRUSTRATED THAT YOU WEREN'T AWARE THAT THEY WERE HAPPENING?

1709

MR. WADE: AND THEN IT SAYS, YOU CITED THE EXAMPLE OF AN HCG SAMPLE THAT WAS DILUTED AND RAN AND ADAM DIDN'T KNOW WHAT IT WAS. DO YOU SEE THAT?

1711

MR. WADE: OKAY. AND THEN HE EXPLAINS DOWN BELOW THAT HIS UNDERSTANDING IS THAT THAT WAS EXPERIMENTAL; RIGHT?

1713

MR. WADE: DO YOU SEE THAT'S WHAT HE SAYS?

1714

ADAM ROSENDORFF: THAT'S WHAT HE'S SAYING.

1715

MR. WADE: BUT HE'S STILL SAYING THAT YOU SHOULD BE IN THE LOOP ON IT; RIGHT?

1716

ADAM ROSENDORFF: WHERE ARE YOU READING THAT?

1717

MR. WADE: WELL, LET'S GO TO THE SECOND PAGE.

1718

ADAM ROSENDORFF: OH, I SEE. I'VE GOT IT. YEAH.

1719

MR. WADE: OKAY. AND IT SAYS YOU HAD ALSO SENT AN EMAIL TO THE CLIA LAB ABOUT NOT RUNNING ANY HCG EXAMPLES ON EDISONS, AND HE DOESN'T KNOW IF THAT WAS CARRIED THROUGH ON OR IF WE LATER DETERMINED THAT THE DATA WAS CORRECT AND GOOD TO GO. DO YOU SEE THAT?

1721

MR. WADE: AND THAT'S BECAUSE AN EXPERIMENT WAS BEING RUN WITHIN THE CLIA LAB?

1722

ADAM ROSENDORFF: I'M NOT FOLLOWING YOU AT ALL, I'M SORRY.

1723

MR. WADE: WELL, DO YOU SEE ON THE PRIOR PAGE HE HAD TALKED ABOUT THERE WAS SOME KIND OF EXPERIMENTAL RUN THAT WAS HAPPENING?

1725

MR. WADE: OKAY. AND THE SUGGESTION WAS THAT MAYBE THAT CREATED SOME KIND OF CONFUSION BECAUSE YOU THOUGHT THAT YOU PUT A HALT TO ALL HCG TESTING?

1726

ADAM ROSENDORFF: YEAH, I DIDN'T -- I DON'T HAVE AN INDEPENDENT RECOLLECTION OF THIS, BUT IT LOOKS LIKE I'M FRUSTRATED BECAUSE I DON'T KNOW IF THAT'S AN EXPERIMENTAL RUN OR THAT'S A PATIENT RUN, AND I'VE ALREADY TOLD FOLKS TO STOP RUNNING HCG ON THE EDISONS.

1727

MR. WADE: RIGHT. AND MR. BALWANI SAYS TO THOSE GENTLEMEN, THIS INFORMATION HAS TO GO THROUGH HIM; RIGHT?

1729

MR. WADE: AND IN THE NEXT PARAGRAPH HE SAYS, "WE NEED TO HONOR SOP'S AND PROCESSES IN CLIA AND IF THERE ARE R&D EXPERIMENTS WE WANT TO RUN THEN THEY SHOULD BE CLEARLY LABELED AS SUCH." DO YOU SEE THAT?

1731

MR. WADE: OKAY. AND THEN HE ASKS, "CAN YOU GUYS PLEASE TOUCH BASE WITH ADAM SO HE IS IN THE LOOP ON ALL HCG DECISIONS ON EDISONS." DO YOU SEE THAT?

1733

MR. WADE: OKAY. LET'S GO TO THE NEXT EMAIL UP THE CHAIN. DO YOU SEE THERE DANIEL SAYS THAT HE UPDATED YOU OVER THE WEEKEND? DO YOU SEE THAT?

1735

MR. WADE: REGARDING THE REVIEW OF THE PAST HCG DATA AND WHAT THEY'RE LOOKING AT MOVING FORWARD. DO YOU SEE THAT?

1737

MR. WADE: AND THERE HAD BEEN A HALT ON FRIDAY; RIGHT?

1739

MR. WADE: AND THERE WAS WORK BEING DONE OVER THE WEEKEND TO ASSESS WHETHER IT WAS OKAY TO DO THE HCG TEST; RIGHT?

1740

ADAM ROSENDORFF: I DON'T KNOW WHAT THE WORK WAS CONDUCTED OR WHAT THE INTENTION WAS.

1741

MR. WADE: BUT IT SAYS HERE THAT THEY HAD UPDATED YOU ON THAT. DO YOU SEE THAT?

1742

ADAM ROSENDORFF: IT'S PRETTY VAGUE. I DON'T REALLY KNOW WHAT DANIEL MEANS IN THIS EMAIL TO BE HONEST.

1743

MR. WADE: OKAY. DO YOU SEE THE PART WHERE IT SAYS, "I UPDATED ADAM OVER THE WEEKEND REGARDING OUR REVIEW OF THE PAST DATA FOR HCG DATA AND WHAT WE WERE LOOKING AT MOVING FORWARDS." DO YOU SEE THAT?

1745

MR. WADE: AND DO YOU SEE THE SUBJECT LINE HCG ON EDISONS?

1747

MR. WADE: AND DO YOU SEE THAT IT SAYS, "WE'LL UPDATE HIM ON THE LATEST EFFORTS ON THIS"?

1750

ADAM ROSENDORFF: IT LOOKS LIKE THEY'RE TRYING TO DO TROUBLESHOOTING AND LOOKING AT PREVIOUS DATA AND WHATNOT?

1751

MR. WADE: BECAUSE YOU HAD HALTED TESTING, RIGHT, SIR?

1753

MR. WADE: YEAH. AND SO THEY WERE TRYING TO FIGURE OUT WHAT WAS GOING ON WITH THE ASSAYS; CORRECT?

1755

MR. WADE: OKAY. AND ISN'T THAT WHAT YOU WOULD EXPECT EVERYONE IN THE COMPANY TO DO AT THAT POINT FOR AN IMPORTANT TEST LIKE HCG?

1756

ADAM ROSENDORFF: FOR ME THE URGENCY WAS TO HAVE AN HCG TEST THAT WAS ACCURATE. THE URGENCY WAS NOT TO PUT IT STRAIGHT BACK ON THE EDISON.

1757

MR. WADE: BUT WHEN THERE'S A PROBLEM, YOU WANT TO LOOK INTO THE PROBLEM AND ADDRESS IT; RIGHT?

1759

MR. WADE: OKAY. LET'S GO UP THE CHAIN. DO YOU SEE THERE MR. BALWANI ACTUALLY FORWARDS THIS TO YOU; RIGHT?

1761

MR. WADE: AND HE TELLS YOU THAT HE'S GOING TO CONTINUE TO MONITOR THIS AND MAKE SURE THAT THIS IS PART OF THE CULTURE; RIGHT?

1763

MR. WADE: AND HE'S NOT TRYING TO UNDERMINE YOUR AUTHORITY; RIGHT?

1764

ADAM ROSENDORFF: THAT CALLS FOR SPECULATION.

1765

MR. WADE: OKAY. I DON'T WANT YOU TO SPECULATE.

1767

MR. WADE: YOU ACKNOWLEDGE IT AND SAY IT MAKES SENSE. SO WERE YOU SPECULATING AT THAT TIME? LET'S GO UP THE CHAIN. DOES THIS HELP INFORM YOUR VIEW AS TO WHETHER MR. BALWANI'S VIEW MADE SENSE?

1768

ADAM ROSENDORFF: I'M AGREEING WITH THE SENTIMENT THAT HE'S EXPRESSING AT THAT TIME, YES.

1769

MR. WADE: OKAY. LET'S GO TO 13875. DO YOU HAVE THAT IN FRONT OF YOU, SIR?

1771

MR. WADE: DO YOU SEE THIS IS ANOTHER EMAIL DURING THAT SAME TIME PERIOD ON HCG ISSUES?

1773

MR. WADE: OKAY. MOVE THE ADMISSION OF 13875.

1774

MR. BOSTIC: NO OBJECTION.

1775

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

1776

(DEFENDANT'S EXHIBIT 13875 WAS RECEIVED IN EVIDENCE.)

1777

MR. WADE: LET'S GO TO THE BOTTOM.

1778

MR. WADE: AND THIS IS AN EMAIL FROM YOU TO MR. BALWANI AND DR. YOUNG; RIGHT?

1780

MR. WADE: AND YOU KNOW FROM MR. BALWANI THAT THE THREE OF YOU HAD DISCUSSED THE PLAN FOR HCG. DO YOU SEE THAT?

1782

MR. WADE: OKAY. AND THEY TALK ABOUT THE WORK THAT IS BEING DONE TO TRY TO FIGURE OUT THAT ASSAY?

1784

MR. WADE: AND YOU'RE TALKING ABOUT THAT?

1786

MR. WADE: OKAY. BECAUSE YOU WERE IN THE LOOP THERE NOW; RIGHT?

1788

MR. WADE: AND YOU SAY DOWN ON THE BOTTOM THAT YOU'RE GOING TO CHANGE HCG TO A VACUTAINER AND RUN IT ON THE IMMULITE; RIGHT?

1790

MR. WADE: AND THAT'S THE PREDICATE DEVICE?

1792

MR. WADE: RIGHT? AND THEN YOU'RE GOING TO HOLD THE EDISON ORDERS AND CALL FOR A REDRAW AS NEEDED; RIGHT?

1794

MR. WADE: OKAY. WHILE YOU'RE LOOKING AT THIS?

1796

MR. WADE: OKAY. LET'S GO UP THE CHAIN. AND THEN DR. YOUNG NOTES WE'RE GOING TO ALSO REPEAT THE IQP STUDY TODAY?

1798

MR. WADE: AND THAT'S THE PRIOR STUDY WE HAVE SEEN IN SOME EMAILS?

1800

MR. WADE: AND TO TEST THE ACCURACY OF THE HCG ASSAY?

1802

MR. WADE: OKAY. AND THEY'RE WORKING ON THAT TODAY?

1804

MR. WADE: WHICH WAS WEDNESDAY, JUNE 4TH, 2014; RIGHT?

1806

MR. WADE: OKAY. AND YOU'RE IN THE LOOP ON THIS; CORRECT?

1808

MR. WADE: OKAY. LET'S GO TO 12660.

1810

MR. WADE: DO YOU HAVE THAT IN FRONT OF YOU?

1812

MR. WADE: AND DO YOU SEE THAT THIS IS ANOTHER EMAIL ON HCG TESTING IN THIS SAME TIME PERIOD?

1814

MR. WADE: WITH PEOPLE IN THE CLIA LAB?

1816

MR. WADE: MOVE THE ADMISSION OF 12660.

1817

MR. BOSTIC: NO OBJECTION.

1818

ADAM ROSENDORFF: I'M NOT ON THE EMAIL BY THE WAY.

1819

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

1820

(DEFENDANT'S EXHIBIT 12660 WAS RECEIVED IN EVIDENCE.)

1821

BY MR. WADE:

1822

MR. WADE: LET'S GO TO THE BOTTOM. DO YOU SEE THE LAST EMAIL ACTUALLY ON THE BOTTOM OF THE SECOND PAGE?

1824

MR. WADE: THIS IS THE EMAIL WHERE YOU'RE HOLDING THE RESULTS. DO YOU SEE THAT?

1826

MR. WADE: AND LET'S GO UP TO THE EMAIL JUST ABOVE IT THAT SAYS, "HI ADAM," FROM HODA?

1828

MR. WADE: AND IT SAYS THAT SHE SEES SOME RESULTS IN LIS FOR HCG FROM EDISON. DO YOU SEE THAT?

1830

MR. WADE: AND SHE'S WONDERING IF THEY CAN BE RELEASED OR IF THEY NEED TO BE SWITCHED. DO YOU SEE THAT?

1832

MR. WADE: OKAY. LET'S GO UP THE CHAIN. THIS IS THEN FORWARDED TO -- MR. BALWANI IS ON THE CHAIN. I THINK MAYBE HE GETS THE CLS EMAILS?

1833

ADAM ROSENDORFF: I HAVE NO IDEA.

1834

MR. WADE: OKAY. LET'S GO TO THE EMAIL ABOVE THAT FROM DR. YOUNG. OKAY. AND HE REPORTS TO MR. BALWANI AND MR. PANGARKAR THAT HE WAS JUST SPEAKING WITH YOU ABOUT THIS AND THAT YOU'RE GOING TO HOLD THE RESULT UNTIL THE STUDY WE ARE RUNNING ON THE EDISON ASSAY IS DONE. DO YOU SEE THAT?

1836

MR. WADE: AND THAT THE DATA SHOULD BE READY TONIGHT. EVERYONE WAS WORKING HARD TO GET THAT STUDY DONE; RIGHT?

1838

MR. WADE: OKAY. AND LET'S -- AND THAT'S -- IF YOU GO UP TO THE TOP, YOU CAN SEE WITH MR. PANGARKAR'S EMAIL THAT THAT'S THAT IQP AAP LIKE STUDY FOR A HCG?

1839

ADAM ROSENDORFF: I'M NOT SURE REALLY WHAT WAS ENTAILED IN THE IQP.

1840

MR. WADE: OKAY. DO YOU SEE THERE IT SAYS THAT THE LAST IQP WAS PERFORMED ON 5-6 AND DEMONSTRATED GOOD CONCORDANCE? DO YOU SEE THAT?

1841

ADAM ROSENDORFF: YES, ACCORDING TO CHINMAY.

1842

MR. WADE: AND THAT SUGGESTS THE RESULTS ARE GOOD?

1843

ADAM ROSENDORFF: NO. CHINMAY IS MAKING AN ASSERTION ABOUT THE RESULTS BEING GOOD.

1844

MR. WADE: I UNDERSTAND. DO YOU RECALL THE RESULTS FROM THE IQP THAT WAS DONE IN THIS TIME PERIOD ON HCG?

1845

ADAM ROSENDORFF: NO, I DO NOT.

1846

MR. WADE: LET'S GO NEXT TO 13876. DO YOU HAVE THAT EMAIL IN FRONT OF YOU?

1848

MR. WADE: AND THAT'S ANOTHER EMAIL ON HCG; CORRECT?

1850

MR. WADE: AND THAT'S ON MID-JUNE 2014?

1852

MR. WADE: I MOVE THE ADMISSION OF 13876.

1853

MR. BOSTIC: NO OBJECTION.

1854

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

1855

(DEFENDANT'S EXHIBIT 13876 WAS RECEIVED IN EVIDENCE.)

1856

MR. WADE: LET'S GO TO THE BOTTOM OF THE FIRST PAGE AND IT CARRIES OVER.

1857

MR. WADE: DO YOU SEE THIS IS JUNE 16TH, 2014, AT 10:30 OR SO?

1859

MR. WADE: OKAY. AND THAT CARRIES OVER TO THE SECOND PAGE. LET'S LOOK AT THE SUBSTANCE OF THE EMAIL. YOU ASK FOR A STATUS UPDATE ON THE HCG ON THE EDISON; RIGHT?

1861

MR. WADE: BECAUSE THERE WERE EFFORTS BEING MADE TO FIGURE OUT GETTING IT BACK ON LINE. DO YOU RECALL THAT, THE STUDIES?

1863

MR. WADE: AND LET'S GO UP THE CHAIN. IT THEN SAYS, "BASED ON REPORTS SINCE FRIDAY, WE HAVE BEEN CONSISTENTLY PASSING QC -- SO WE DON'T HAVE A PROBLEM WITH THE CURRENT BUILD." DO YOU SEE THAT?

1865

MR. WADE: AND THAT MEANS THAT THE CURRENT BUILD IS THE CARTRIDGE BUILD?

1866

ADAM ROSENDORFF: I DON'T RECALL.

1867

MR. WADE: OKAY. THE QC IS BEING DONE ON DEVICES THAT ARE RUNNING WITHIN THE CLIA LAB; RIGHT?

1868

ADAM ROSENDORFF: I DON'T KNOW ACTUALLY. HE'S SAYING THAT IT'S CONSISTENTLY PASSING QC. I DON'T KNOW IF HE'S RUNNING QC ON EDISONS, WHERE THOSE EDISONS ARE, IF THEY'RE IN THE CLIA LAB, IF THEY'VE BEEN QUALIFIED IN THE CLIA LAB. I HAVE NO IDEA WHAT EDISONS HE'S RUNNING THIS QC ON.

1869

MR. WADE: LET'S WORK UP THE CHAIN. YOU RESPOND AND SAY, "GREAT THANKS." DO YOU SEE THAT?

1871

MR. WADE: AND LET'S GRAB THE REST OF THE EMAILS FROM THE TOP. IT SAYS, "IN PARALLEL, A NEW BUILD HAS ALSO BEEN PLANNED AND IS ON HIGH PRIORITY." DO YOU SEE THAT?

1873

MR. WADE: AND THEY'RE WORKING ON ANOTHER ONE. AND YOU ASK "SO HCG IS BACK ON VACUTAINERS." DO YOU SEE THAT?

1875

MR. WADE: AND IF IT WAS BACK ON VACUTAINERS, THAT WOULD MEAN IT WOULD HAVE TO GO OFF OF THE EDISON AND BACK ON THE VACUTAINERS; RIGHT?

1877

MR. WADE: AND THAT SUGGESTS IT WAS ON EDISON DURING THIS TIME PERIOD; RIGHT?

1878

ADAM ROSENDORFF: I DON'T KNOW.

1879

MR. WADE: WELL, LET'S LOOK AT THE TOP EMAIL. MR. BALWANI MAKES CLEAR IT WAS ACTUALLY ON THE NANOTAINERS WHICH WERE BEING USED ON THE EDISON DEVICE DURING THIS TIME PERIOD, DOES IT NOT?

1880

ADAM ROSENDORFF: WELL, THAT'S HIS ASSERTION.

1881

MR. WADE: OKAY. DID YOU DO ANY FOLLOWUP TO SEE WHETHER THIS WAS THE CASE IN THIS PERIOD?

1882

ADAM ROSENDORFF: NO, I WASN'T POLICE -- I MADE A DECISION THAT HCG SHOULD BE ON VACUTAINERS. I ASSUMED THAT WAS BEING FOLLOWED ON. I DIDN'T DO ANY POLICING ON MY OWN OF THIS.

1883

MR. WADE: SIR, YOU WERE ACTIVELY INVOLVED IN THE RESEARCH AND DEVELOPMENT WORK THAT WAS BEING DONE ON THAT AND THE INVESTIGATION THAT WAS BEING DONE TO WORK TO GET THE EDISON ASSAY BACK ONLINE; RIGHT?

1884

ADAM ROSENDORFF: I WAS INFORMED OF THE INVESTIGATION EFFORTS, YES.

1885

MR. WADE: YEAH. AND YOU'RE ASKING QUESTIONS AND THEY'RE TELLING YOU IN THIS EMAIL THAT IT'S BACK ON THE EDISON DEVICE, ARE THEY NOT, SIR?

1886

ADAM ROSENDORFF: THAT'S WHAT SUNNY IS SAYING, YES.

1887

MR. WADE: OKAY. YOU'RE BEING TOLD AT THIS TIME IT'S BACK ON THE EDISON DEVICE?

1889

MR. WADE: LET'S GO TO 13877. DO YOU HAVE THAT IN FRONT OF YOU?

1891

MR. WADE: CORRECT.

1892

ADAM ROSENDORFF: I HAVE THAT.

1893

MR. WADE: YOU HAVE THAT IN FRONT OF YOU?

1895

MR. WADE: AND THAT'S ANOTHER EMAIL ON HCG IN JUNE OF 2014?

1897

MR. WADE: MOVE THE ADMISSION OF 13877.

1898

MR. BOSTIC: NO OBJECTION.

1899

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

1900

(DEFENDANT'S EXHIBIT 13877 WAS RECEIVED IN EVIDENCE.)

1901

MR. WADE: AND IF WE CAN JUST BLOW UP THE TOP THIRD OR SO.

1902

MR. WADE: THIS IS AN EMAIL FROM MAX FOSQUE TO A GROUP OF PEOPLE WITHIN THE CLIA LAB. DO YOU SEE THAT?

1904

MR. WADE: AND THAT INCLUDES YOU. DO YOU SEE THAT?

1906

MR. WADE: AND THIS IS DISCUSSING THE USE OF THE EDISON DEVICE IN THE CLIA LAB?

1908

MR. WADE: IN JUNE 18TH, 2014?

1910

MR. WADE: AND THAT'S AFTER YOUR HOLD; CORRECT?

1912

MR. WADE: LET'S GO TO 13878. THAT'S ANOTHER EMAIL ABOUT HCG ON THE EDISON DEVICE; CORRECT?

1914

MR. WADE: I WOULD MOVE 13878.

1915

MR. BOSTIC: NO OBJECTION.

1916

JUDGE DAVILA: IT'S ADMITTED AND MAY BE PUBLISHED.

1917

(DEFENDANT'S EXHIBIT 13878 WAS RECEIVED IN EVIDENCE.)

1918

BY MR. WADE:

1919

MR. WADE: SIR, THIS EMAIL REFLECTS DISCUSSION ABOUT THE USE OF THE EDISON DEVICE IN THE CLIA LAB IN JULY OF 2014?

1921

MR. WADE: I DON'T HAVE ANY OTHER QUESTIONS ON THIS ONE. I HAVE ANOTHER LINE OF HCG QUESTIONING THAT I'D LIKE TO ASK YOU ABOUT SOME OF YOUR TESTIMONY RELATING TO EXHIBIT 4840. IF WE CAN BRING THAT UP. IF WE CAN BLOW UP THE EMAIL IN THE MIDDLE. DO YOU RECALL BEING ASKED QUESTIONS ABOUT THESE EMAILS?

1923

MR. WADE: AND IN PARTICULAR I THINK THE GOVERNMENT FOCUSSED YOU -- IF YOU LOOK AT THAT BOTTOM EMAIL IT SAYS, "HCG RIGHT NOW IS CAUSING SOME SERIOUS ISSUES AND PATIENT COMPLAINTS." DO YOU SEE THAT?

1925

MR. WADE: AND HE SAYS HE'S BEEN SPENDING ALL OF HIS MORNING TALKING TO DOCTORS ABOUT HCG?

1927

MR. WADE: AND YOU WERE ASKED WHETHER YOU WERE PART OF THE CONVERSATIONS WITH DOCTORS IN THIS TIME PERIOD ON HCG?

1928

ADAM ROSENDORFF: I DON'T RECALL.

1929

MR. WADE: AND DO YOU RECALL BEING QUESTIONED THAT THERE WAS A SUGGESTION THAT THIS WAS A MEDICAL ISSUE AND YOU SHOULD BE, YOU SHOULD BE INVOLVED IN MEDICAL ISSUES; RIGHT? DO YOU RECALL THAT?

1930

ADAM ROSENDORFF: I DON'T KNOW IF YOU'RE REFERRING TO AN EMAIL OR TO THE GOVERNMENT'S LINE OF QUESTIONING OR WHAT YOU'RE REALLY REFERRING TO RIGHT NOW.

1931

MR. WADE: I'M REFERRING TO THE GOVERNMENT'S LINE OF QUESTIONING ABOUT THIS EMAIL.

1933

MR. WADE: AND THEY WERE TRYING TO SUGGEST THAT YOU SHOULD BE INVOLVED IN MEDICAL ISSUES; CORRECT?

1935

MR. WADE: AND YOU THOUGHT YOU SHOULD?

1937

MR. WADE: AND YOU DIDN'T THINK YOU WERE; CORRECT?

1939

MR. WADE: OKAY. LET'S -- LET ME FOCUS ON THE -- LET ME FOCUS PARTICULARLY ON THAT LAST LINE THERE. YOU SEE, "IT'S A SENSITIVE ONE OBVIOUSLY B/C OF PEOPLE FINDING OUT IF PREGNANT." DO YOU SEE THAT?

1941

MR. WADE: AND THAT'S WHAT -- LET ME START OVER. AN HCG TEST WILL HELP INFORM PEOPLE, A WOMAN IF SHE'S PREGNANT; CORRECT?

1943

MR. WADE: LET'S LOOK UP THIS CHAIN. DO YOU RECALL WHAT THE ISSUE WAS THAT MR. HOLMES WAS ADDRESSING HERE WHEN YOU LOOK AT THIS NEXT EMAIL UP HERE? LET'S HIGHLIGHT IT. THERE WERE CAPACITY ISSUES; RIGHT?

1945

MR. WADE: NOT MEDICAL ISSUES?

1947

MR. WADE: THESE WERE CAPACITY ISSUES; CORRECT?

1948

ADAM ROSENDORFF: YES. THAT'S WHAT CHRISTIAN IS SAYING, YES.

1949

MR. WADE: OKAY. AND THAT WAS THE CASE, WAS IT NOT?

1950

ADAM ROSENDORFF: I CAN EXPLAIN WHY.

1951

MR. WADE: I'M JUST ASKING RIGHT NOW.

1952

ADAM ROSENDORFF: I DON'T RECALL IF THERE WERE CAPACITY ISSUES. I DON'T RECALL IF THERE WERE CAPACITY ISSUES AT THAT TIME.

1953

MR. WADE: OKAY. AND JUST SO WE'RE CLEAR, THIS IS RAISED AT 2:35. DO YOU SEE THAT?

1955

MR. WADE: I'M SORRY, 12:35.

1957

MR. WADE: THANK YOU. AND DO YOU SEE MS. HOLMES RESPONDS THAT SHE WILL RESPOND WITHIN A HALF HOUR AND SAY SHE'LL CONNECT AS SOON AS SHE'S OUT; RIGHT?

1959

MR. WADE: AND 30 MINUTES. DO YOU CONSIDER THAT A PROMPT RESPONSE?

1961

MR. WADE: OKAY. LET'S JUST GO UP TO THE TOP AGAIN BECAUSE I THINK MAYBE YOU WERE ASKING ABOUT THIS PIECE OF AN EMAIL. SAME DOCUMENT. LET'S BLOW UP THAT TOP EMAIL. AND IT TALKS ABOUT HOW MR. HOLMES HAD JUST SPOKE WITH ONE OF THE PATIENT'S HUSBANDS AND THE DOCTOR. DO YOU SEE THAT?

1963

MR. WADE: AND THAT DOCTOR HAD APPARENTLY SENT SEVERAL PEOPLE THERE?

1965

MR. WADE: OVER FOUR DAYS; RIGHT?

1967

MR. WADE: AND ORIGINALLY HE SAID HE WON'T SEND US ANY MORE PATIENTS BECAUSE WE'VE HAD ISSUES WITH ALL THREE; RIGHT?

1969

MR. WADE: AND THE ISSUES WITH ALL THREE WERE THAT THE RESPONSES WERE NOT COMING BACK; RIGHT?

1970

ADAM ROSENDORFF: I DON'T KNOW IF THE ISSUES WERE ACCURACY OR TURNAROUND TIME.

1971

MR. WADE: OKAY. WELL, LET'S TAKE A LOOK AT THE LAST CHAIN IN THE EMAIL, THE LAST TWO EMAILS ON THE BOTTOM OF PAGE 3. AND I DON'T THINK THE GOVERNMENT SHOWED YOU THESE. OKAY. NOW, THESE ARE EMAILS FROM THE CUSTOMER SERVICE FOLKS; RIGHT?

1973

MR. WADE: AND BOTH OF THESE EMAILS TALK ABOUT DOCTORS CALLING LOOKING FOR RESULTS; RIGHT?

1975

MR. WADE: NOT COMPLAINING ABOUT INACCURATE RESULTS, BUT LOOKING FOR RESULTS?

1977

MR. WADE: BECAUSE THEY HAD NOT GOTTEN THE RESULTS BACK; RIGHT?

1978

ADAM ROSENDORFF: YES, THAT'S WHAT IT LOOKS LIKE.

1979

MR. WADE: OKAY. NOW LET'S GO BACK UP TO THE TOP EMAIL. AND DO YOU RECALL THAT THAT IS WHAT MR. HOLMES WAS TALKING ABOUT IN THIS TIME PERIOD? MAYBE IF WE LOOK AT THAT SECOND PARAGRAPH IT WILL HELP. DO YOU SEE THERE IT SAYS, "AS FOR CURRENT STATUS OF HCG, WE ARE WORKING IN PARALLEL TO RUN SAMPLE ON EDISON AS WELL AS IMMULITE. BUT WE FOUND OUT THIS MORNING THAT REAGENTS FOR IMMULITE ARE ON ORDER AND BACK ORDERED." DO YOU SEE THAT?

1980

ADAM ROSENDORFF: UH-HUH, UH-HUH.

1981

MR. WADE: AND SO THIS HCG ISSUE WAS A BACKLOG ISSUE. DO YOU RECALL THAT?

1982

ADAM ROSENDORFF: I DON'T RECALL. I DON'T RECALL FROM 2,000, NO, I DON'T RECALL THAT.

1983

MR. WADE: OKAY. DO YOU RECALL THAT THERE WERE PATIENTS THAT WERE WAITING TO GET THE RESULTS AND THAT THAT WAS THE PROBLEM?

1984

ADAM ROSENDORFF: I'M READING THAT FROM THE EMAIL THAT YOU'RE SHOWING ME, YES.

1985

MR. WADE: WELL, LET'S SEE IF WE CAN HELP YOU REFRESH. LET'S LOOK AT 13881.

1987

MR. WADE: AND THIS IS AN EMAIL WITH VARIOUS PEOPLE IN THE CHAIN, THE SUBJECT OF WHICH IS INVENTORY; CORRECT?

1989

MR. WADE: AND IT RELATES TO REAGENT INVENTORY; CORRECT?

1991

MR. WADE: WITHIN THE CLIA LAB?

1993

MR. WADE: FOR A NON-THERANOS MACHINE; RIGHT?

1995

MR. WADE: OKAY. MOVE THE ADMISSION OF 13881.

1996

MR. BOSTIC: NO OBJECTION.

1997

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

1998

(DEFENDANT'S EXHIBIT 13881 WAS RECEIVED IN EVIDENCE.)

1999

BY MR. WADE:

2000

MR. WADE: OKAY. LET'S GO TO THE END. SO THIS IS MR. BALWANI FOLLOWING UP ON THAT IMMULITE REAGENT ISSUE THAT WAS MENTIONED BY MS. HOLMES; CORRECT?

2002

MR. WADE: AND HE'S SAYING -- HE'S ASKING WHAT IS HAPPENING; RIGHT?

2004

MR. WADE: AND HE'S ASKING WHO WAS RESPONSIBLE BECAUSE HE JUST DISCOVERED THAT YOU RAN OUT OF HCG REAGENT FOR THE IMMULITE; RIGHT?

2006

MR. WADE: AND THAT'S A PROBLEM BECAUSE IT'S CREATING A BACKLOG; RIGHT?

2008

MR. WADE: OKAY. AND WHO IS RESPONSIBLE FOR ENSURING THAT THERE ARE REAGENTS WITHIN THE CLIA LAB?

2009

ADAM ROSENDORFF: A SUPERVISOR.

2011

ADAM ROSENDORFF: OR A CLS, SOMETHING LIKE THAT.

2012

MR. WADE: OKAY. SOMEONE UNDER YOUR GROUP?

2014

MR. WADE: OKAY. AND IF WE JUST GO UP THE CHAIN. AND IF WE HAVE THE CHAIN -- I'M SORRY, YOU HAD THE RIGHT EMAIL, MR. BENNETT. YOU PROVIDED CLARIFICATION FOR MR. BALWANI ON WHY THERE WAS THIS HCG BACKLOG IN THE CLIA LAB ON THE IMMULITE; RIGHT?

2016

MR. WADE: AND YOU NOTE WHOSE RESPONSIBILITY IT WAS; RIGHT?

2018

MR. WADE: OKAY. JUST SO WE'RE CLEAR, THIS HAD NOTHING TO DO WITH THE EDISON DEVICE, THIS WAS AN IMMULITE ISSUE?

2020

MR. WADE: AND A SUPPLY OR INVENTORY ISSUE; RIGHT?

2022

MR. WADE: AND LET'S GO UP JUST TO THE TOP EMAIL. THIS IS AN EMAIL WHERE YOU'RE HAVING A DISCUSSION WITH MR. BALWANI ABOUT ONE OF YOUR SUBORDINATES; RIGHT?

2024

MR. WADE: AND ABOUT SOME CHALLENGES THAT YOU WERE HAVING IN MANAGEMENT OF THAT SUBORDINATE; CORRECT?

2026

MR. WADE: AND TALKING THROUGH WITH YOUR SUPERVISOR WAYS IN WHICH YOU MIGHT WORK TO IMPROVE THAT; IS THAT FAIR?

2028

MR. WADE: OKAY. AND THAT'S A PERFECTLY APPROPRIATE CONVERSATION TO HAVE WITH TWO MORE SENIOR PEOPLE ABOUT A SUBORDINATE; IS IT NOT?

2029

ADAM ROSENDORFF: IN MY -- YES, IN MY OPINION.

2030

MR. WADE: OKAY. I DON'T HAVE ANY MORE QUESTIONS ON THAT TOPIC, SIR. I'D LIKE TO ASK YOU A FEW QUESTIONS, SIR, ABOUT WHAT I'M GOING TO REFER TO AS THE SIXTH TIP POLICY. OKAY?

2032

MR. WADE: NOW, THE EDISON DEVICES HAD SIX TIPS THAT HAD RAN IN ORDER TO PERFORM ON EACH INDIVIDUAL BLOOD SAMPLE; IS THAT CORRECT?

2033

ADAM ROSENDORFF: NOT ORIGINALLY. THE ORIGINAL EDISON DEVICES HAD THREE TIPS.

2034

MR. WADE: IT HAD THREE TIPS?

2036

MR. WADE: AND THEN IT WAS MODIFIED IN EARLY 2014 TO USE SIX TIPS; RIGHT?

2037

ADAM ROSENDORFF: I BELIEVE SO.

2038

MR. WADE: AND DO YOU RECALL THAT -- AND JUST SO THE JURY IS CLEAR, EACH OF THOSE TIPS ESSENTIALLY DELIVERS A RESULT; CORRECT? OR WHY DON'T YOU EXPLAIN TO US HOW EACH OF THOSE SIX TIPS OPERATE WITHIN THE EDISON?

2039

ADAM ROSENDORFF: YEAH. THOSE TIPS ARE -- I DON'T WANT TO GET TOO TECHNICAL, BUT THE TIPS ARE COATED WITH ANTIBODIES. EACH TIP IS EXPOSED TO THE PATIENT SAMPLE. THE ANTIBODIES BIND TO THE ANALYTE, AND THEN A SECONDARY ANTIBODY DETECTS THE PRIMARY ANTIBODY. THE SECONDARY ANTIBODY IS CONJUGATED TO A CHLOROPHYLL, WHICH IS FLUORESCENT. EACH TIP GIVES OUT A SIGNAL. THERE ARE DIFFERENT CONFIGURATIONS. I WON'T GO INTO THAT WHETHER IT'S A COMPETITIVE ELISA OR A DIRECT OR INDIRECT. AND ESSENTIALLY EACH TIP REPORTS OUT A RESULT IN A RELATIVE LIGHT UNITS AND IN CONCENTRATION.

2040

MR. WADE: AND SO YOU HAVE SIX RESULTS FOR ONE SAMPLE; CORRECT?

2042

MR. WADE: AND THAT'S FOR A SINGLE ASSAY?

2044

MR. WADE: AND ACTUALLY FOR EACH ASSAY; CORRECT?

2046

MR. WADE: AND UNDER THE POLICY THAT THE COMPANY ADOPTED AFTER IT MOVED TO THE SIXTH TIP POLICY OR THE SIXTH TIP FORMAT?

2048

MR. WADE: TWO RESULTS OF THOSE SIX TIPS COULD BE DISCARDED AND THEN THE REMAINING FOUR RESULTS FROM THE FOUR OTHER TIPS WOULD BE AVERAGE TO PRODUCE THE RESULT; CORRECT?

2050

MR. WADE: OKAY. AND I UNDERSTAND THAT THIS PRACTICE WHERE YOU MOVED TO AN AVERAGE FOUR WAS SOMETHING THAT WAS DEVELOPED BY DR. YOUNG; IS THAT CORRECT?

2052

MR. WADE: AND I UNDERSTAND THAT WAS SOMETHING THAT YOU APPROVED; CORRECT?

2053

ADAM ROSENDORFF: THERE WAS NO FORMAL PROCEDURE SOP REGARDING -- OR POLICY REQUIRING ASSAY DETECTION. I WAS TOLD BY DANIEL THAT THERE WAS AN ALGORITHM INSIDE THE 3.5 THAT WOULD DO THOSE AUTOMATICALLY.

2054

MR. WADE: RIGHT. BECAUSE INITIALLY IT WAS DONE MANUALLY BEFORE IT WAS AUTOMATED; RIGHT?

2055

ADAM ROSENDORFF: I BELIEVE SO.

2056

MR. WADE: AND THEN THAT POLICY OF AVERAGING THE FOUR AND REMOVING THE TWO WAS AUTOMATED, YOU UNDERSTAND, WITHIN THE ALGORITHM; RIGHT?

2058

MR. WADE: AND YOU KNEW THAT WAS GOING TO HAPPEN?

2060

MR. WADE: AND THAT WASN'T A SECRET; RIGHT?

2061

ADAM ROSENDORFF: DANIEL TOLD ME THAT'S WHAT WAS GOING TO HAPPEN.

2062

MR. WADE: AND YOU APPROVED OF THAT; CORRECT?

2063

ADAM ROSENDORFF: I THOUGHT IT WAS REASONABLE, YES.

2064

MR. WADE: OKAY. WELL, DO YOU RECALL --

2065

ADAM ROSENDORFF: I THOUGHT IT WAS UNUSUAL. I HADN'T REALLY HEARD OF THIS BEING DONE BEFORE.

2066

MR. WADE: RIGHT. DO YOU RECALL THAT YOU WERE ASKED IF THAT WAS SOMETHING THAT YOU APPROVED IN YOUR DEPOSITION AND YOU SAID YES?

2068

MR. WADE: OKAY. AND DOES THAT REMAIN TRUE TODAY?

2070

MR. WADE: OKAY. AND OTHER SCIENTISTS IN THE LAB APPROVED OF IT AS WELL; CORRECT?

2071

ADAM ROSENDORFF: I DON'T KNOW.

2072

MR. WADE: DO YOU RECALL IN YOUR DEPOSITION THAT YOU WERE ASKED THAT OTHER SCIENTISTS IN THE LAB APPROVED AS WELL, CORRECT, AND YOU SAID YES?

2073

ADAM ROSENDORFF: I SUPPOSE SO. I DON'T RECALL EVERY WORD OF MY DEPOSITION, NO.

2074

MR. WADE: OKAY. DR. PANDORI APPROVED OF IT; RIGHT?

2075

ADAM ROSENDORFF: I DON'T KNOW.

2076

MR. WADE: YOU RECALL IN YOUR DEPOSITION THAT YOU SAID THAT DR. PANDORI APPROVED OF IT?

2077

ADAM ROSENDORFF: I DON'T KNOW.

2078

MR. WADE: WHY DON'T WE TAKE A LOOK. THIS IS GOING TO BE DX 11000.

2079

JUDGE DAVILA: IS THIS TO REFRESH A WITNESS'S RECOLLECTION?

2080

MR. WADE: IT IS, YOUR HONOR. IT'S IN ONE OF THE YELLOW BINDERS. IT'S YOUR DEPOSITION TESTIMONY FROM ARIZONA.

2081

ADAM ROSENDORFF: OH, I THOUGHT WE WERE TALKING ABOUT MY TESTIMONY YESTERDAY WITH THE GOVERNMENT. I'M SORRY. I MISUNDERSTOOD WHAT YOU WERE REFERRING TO.

2082

BY MR. WADE:

2083

MR. WADE: OKAY. LET ME TRY AGAIN. DO YOU RECALL TESTIFYING IN YOUR DEPOSITION IN ARIZONA UNDER OATH; CORRECT?

2085

MR. WADE: AND YOU RAISED YOUR HAND AND AGREED TO TELL THE TRUTH?

2087

MR. WADE: OKAY. AND DO YOU RECALL BEING ASKED WHETHER DR. PANDORI APPROVED OF THIS AND YOU ANSWERED YES?

2088

ADAM ROSENDORFF: I HONESTLY DON'T RECALL WHAT WAS DISCUSSED IN THE DEPOSITION. I CAN READ THROUGH THE TRANSCRIPT.

2089

MR. WADE: IF YOU COULD DRAW YOUR ATTENTION TO PAGE 228, LINES 18 TO 22 AND READ THEM TO YOURSELF, AND LET ME KNOW WHEN YOU'RE DONE, DOCTOR.

2090

(PAUSE IN PROCEEDINGS.)

2091

ADAM ROSENDORFF: I'VE READ IT.

2092

BY MR. WADE:

2093

MR. WADE: OKAY. DOES THAT REFRESH YOUR RECOLLECTION THAT YOU TESTIFIED THAT DR. PANDORI APPROVED OF THIS PRACTICE AS WELL?

2094

ADAM ROSENDORFF: AS I SAID, I DON'T HAVE AN INDEPENDENT RECOLLECTION OF MY DEPOSITION. I'M JUST READING THE CONTENT, AND THAT'S WHAT IT SAYS, YES.

2095

MR. WADE: AND DOES THAT REFRESH YOUR RECOLLECTION THAT THAT'S WHAT -- THAT WAS YOUR VIEW?

2096

ADAM ROSENDORFF: NO, IT DOES NOT REFRESH MY RECOLLECTION.

2097

MR. WADE: OKAY. AND JUST SO WE'RE CLEAR, THIS WAS -- THIS WOULD NOT BE A POLICY THAT WOULD BE IMPLEMENTED BY MS. HOLMES AS THE CEO OF THE COMPANY; CORRECT?

2099

MR. WADE: AND IT WAS IN THE CLIA LAB?

2101

MR. WADE: AND IT WAS UNDER YOUR CONTROL; RIGHT?

2102

ADAM ROSENDORFF: I TRIED TO CONTROL EVERYTHING THAT I POSSIBLY COULD.

2103

MR. WADE: RIGHT. I UNDERSTAND. AND YOU, UNDER THE REGULATIONS, WERE IN CHARGE OF THE CLIA LAB?

2105

MR. WADE: AND THIS POLICY OF THE SIXTH TIP PRACTICE IN AVERAGING FOUR OF THOSE RESULTS WAS SOMETHING THAT WAS WELL-KNOWN TO YOU; RIGHT?

2107

MR. WADE: AND IT WAS BEING DONE BOTH ON RESULTS AND QUALITY CONTROL; RIGHT?

2109

MR. WADE: YES. AND YOU APPROVED OF THAT PRACTICE; RIGHT?

2110

ADAM ROSENDORFF: I DISCUSSED IT WITH DANIEL, AND I BELIEVE I AGREED AND APPROVED IT AND DISCUSSED IT WITH HIM, YEAH.

2111

MR. WADE: YES. AND JUST SO YOU'RE AWARE, I BELIEVE YOU WERE ASKED A QUESTION DURING YOUR DIRECT EXAMINATION RELATING TO WHETHER ANY COMMERCIAL DEVICES AVERAGE CALCULATIONS; RIGHT?

2113

MR. WADE: YES. LET'S TAKE A LOOK AT EXHIBIT 392, WHICH IS A BIG ONE, BUT I'M ONLY GOING TO ASK YOU ABOUT A VERY SMALL PORTION OF IT. LET ME KNOW WHEN YOU HAVE THAT.

2114

ADAM ROSENDORFF: THIS IS THE OPERATOR'S GUIDE TO THE IMMULITE.

2115

MR. WADE: THIS IS THE OPERATOR'S GUIDE TO THE IMMULITE IMMUNOASSAY SYSTEM; CORRECT?

2117

MR. WADE: AND THIS WAS ONE OF THE DEVICES THAT WAS USED IN THE CLIA LAB; RIGHT?

2119

MR. WADE: I MOVE THE ADMISSION OF 392.

2120

MR. BOSTIC: NO OBJECTION.

2121

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

2122

(GOVERNMENT'S EXHIBIT 392 WAS RECEIVED IN EVIDENCE.)

2123

MR. WADE: I THINK EVERYONE WILL BE THANKFUL WE'RE GOING TO LOOK AT ONE PAGE OF THIS.

2124

(LAUGHTER.)

2125

BY MR. WADE:

2126

MR. WADE: I'D ASK YOU TO LOOK AT PAGE 41 OF THE EXHIBIT NUMBER THAT IS. LET ME KNOW WHEN YOU'RE THERE.

2128

MR. WADE: DO YOU SEE AT THE TOP OF THAT PAGE IT TALKS ABOUT THE INSTRUMENT READINGS? DO YOU SEE THAT?

2130

MR. WADE: AND IT EXCLUDES CERTAIN OF THE DARK COUNTS FROM ITS CALCULATION; CORRECT?

2132

MR. WADE: AND THEN IT AVERAGES FIVE INDIVIDUAL READINGS; CORRECT?

2134

MR. WADE: I DON'T HAVE ANY OTHER QUESTIONS ABOUT THAT.

2136

MR. WADE: DO YOU RECALL YOU WERE ASKED SOME QUESTIONS ABOUT DEMOS; RIGHT?

2138

MR. WADE: AND I JUST WANT TO MAKE SURE THE RECORD IS CLEAR, YOU WERE NOT IN THE ROOM WITH ANY VIP'S OR INVESTORS?

2139

ADAM ROSENDORFF: NO, I WAS NOT.

2140

MR. WADE: THE ONLY QUESTION I HAVE FOR YOU RELATING TO THAT IS YOU WEREN'T CONCERNED ABOUT THE RESOURCES ASSIGNED TO DEMOS, THAT THEY WEREN'T DISRUPTIVE IN THE LAB; RIGHT?

2141

ADAM ROSENDORFF: NO, NOT AT ALL.

2142

MR. WADE: WE'VE TALKED A LOT AT DIFFERENT TIMES ABOUT THE DOCTOR INQUIRIES AND THE HANDLING OF THE DOCTOR INQUIRIES. DO YOU RECALL THAT?

2144

MR. WADE: AND DO YOU RECALL THAT THERE WERE MULTIPLE WAYS THAT THERANOS HAD FOR DOCTORS TO RAISE QUESTIONS; RIGHT? WELL, THEY HAD A CUSTOMER SERVICE LINE; RIGHT?

2146

MR. WADE: AND DID THAT GO TO YOUR DESK AND DID YOU PICK UP THE PHONE?

2148

MR. WADE: THANKFULLY.

2150

MR. WADE: THAT COULD BE A TOUGH JOB; RIGHT?

2152

MR. WADE: AND YOU COULD BE FIELDING A LOT OF QUESTIONS; RIGHT?

2153

ADAM ROSENDORFF: I STILL DO THAT AT MY CURRENT JOB.

2154

MR. WADE: WHAT IS YOUR CURRENT JOB?

2155

ADAM ROSENDORFF: I'M A LAB DIRECTOR AT THE VALENCIA BRANCH LABORATORY. IT'S A JOINT VENTURE BETWEEN PERKIN ELMER AND THE CALIFORNIA DEPARTMENT OF PUBLIC HEALTH FOR COVID TESTING.

2156

MR. WADE: AND YOU STILL FIELD --

2158

MR. WADE: -- QUESTIONS TODAY?

2160

MR. WADE: BUT FOR THE MOST PART THERE ARE A LOT OF -- THERE ARE CUSTOMER SERVICE REPRESENTATIVES WHO ARE SUPPOSED TO KIND OF SEPARATE THE WHEAT FROM THE SHAFT; RIGHT?

2161

ADAM ROSENDORFF: IDEALLY, YES.

2162

MR. WADE: AND THEY RAISED THE ISSUES THAT ARE APPROPRIATE FOR YOUR CONSIDERATION; RIGHT?

2164

MR. WADE: OKAY. AND THERE ARE ALSO SALES REPRESENTATIVES THAT ARE OFTEN OUT IN THE FIELD AND THEY'RE DEALING WITH DOCTORS; RIGHT?

2165

ADAM ROSENDORFF: YES. LUCKILY FOR COVID, IT'S NOT SOMETHING THAT YOU HAVE TO GO OUT AND SELL TO PEOPLE.

2167

ADAM ROSENDORFF: IT'S SOMETHING THAT IS REALLY NEEDED.

2168

MR. WADE: SO YOU'RE NOT DOING THAT IN YOUR CURRENT JOB?

2170

MR. WADE: BUT IN THERANOS, AT THERANOS THEY WERE OUT AS PART OF THEIR COMMERCIAL EFFORTS AND THEY HAD PEOPLE OUT TALKING TO DOCTORS; RIGHT?

2171

ADAM ROSENDORFF: I WASN'T REALLY AWARE OF THE SALES, THE THERANOS SALES FORCE AND WHAT THE ACTIVITIES WERE IN THAT REGARD. I WASN'T INVOLVED.

2172

MR. WADE: WELL, YOU TALKED ABOUT, YOU MAY RECALL, ON TUESDAY ABOUT ALL OF THE PEOPLE AT THERANOS WHO WERE CONTRIBUTING TO MAKING THE SYSTEM WORK; RIGHT? DO YOU RECALL THAT?

2174

MR. WADE: AND THAT INVOLVED A LOT OF DIFFERENT PEOPLE WHO WOULD TAKE INPUTS FROM DIFFERENT CUSTOMERS; RIGHT?

2176

MR. WADE: AND SOMETIMES THOSE ISSUES WOULD BE APPROPRIATE FOR YOU; RIGHT?

2178

MR. WADE: AND SOMETIMES THEY WOULDN'T BE APPROPRIATE FOR YOU; IS THAT RIGHT?

2180

MR. WADE: AND WHEN IT CAME TO THE INTERPRETATION OF THE TEST RESULTS, THAT IS A THING THAT YOU NEEDED TO BE INVOLVED IN; RIGHT?

2182

MR. WADE: BECAUSE THERE'S ACTUALLY A SPECIFIC REGULATION WITHIN THE FEDERAL CLIA LAB REGULATIONS THAT RELATE TO THE INTERPRETATION OF LAB RESULTS; CORRECT?

2184

MR. WADE: BUT THEY DON'T REQUIRE YOU TO DEAL WITH EACH AND EVERY THING THAT COMES UP; RIGHT?

2185

ADAM ROSENDORFF: I BELIEVE THE REGULATIONS SAY THAT THE LABORATORY MUST MAKE AVAILABLE TO CLIENTS CONSULTATION REGARDING INTERPRETATION OF TEST RESULTS. SOMETHING TO THAT EFFECT. IN OTHER WORDS, IF SOMEBODY CALLS AND WANTED TO KNOW HOW YOU INTERPRET A TEST, A LAB DIRECTOR WOULD HANDLE THAT, YEAH.

2186

MR. WADE: RIGHT. THE REGULATION REQUIRES THAT THE LAB DIRECTOR MUST ENSURE THAT CONSULTATION IS AVAILABLE TO THE LABORATORY'S CLIENTS ON MATTERS RELATING TO THE QUALITY OF THE TEST RESULTS REPORTED AND THEIR INTERPRETATION CONCERNING SPECIFIC PATIENT CONDITIONS; RIGHT?

2187

ADAM ROSENDORFF: ARE YOU READING THE STATUTE?

2188

MR. WADE: I AM. I WOULD BE HAPPY TO SHOW IT TO YOU.

2189

ADAM ROSENDORFF: THAT'S FINE. IT SOUNDS LIKE YOU ARE, YEAH.

2190

MR. WADE: AND DOES THAT SOUND ABOUT RIGHT?

2192

MR. WADE: AND SO THE REQUIREMENT IS THAT YOU NEED TO BE AVAILABLE TO DO THAT; RIGHT?

2194

MR. WADE: AND NOT THAT YOU HAVE TO BE THE ONLY AND EXCLUSIVE PERSON WHO DOES IT; RIGHT?

2195

ADAM ROSENDORFF: THAT'S RIGHT.

2196

MR. WADE: AND SOMETIMES DOCTORS WOULD RAISE ISSUES AND -- OR HAVE QUESTIONS, AND IT WOULDN'T PROMPT -- AND THEY WOULDN'T HAVE MUCH VALIDITY TO IT OR IT WOULDN'T BE OF REAL CONCERN TO YOU; CORRECT?

2197

ADAM ROSENDORFF: BY THE TIME THAT THEY WERE ESCALATED TO ME, THE VAST MAJORITY OF THEM POINTED TO SERIOUS ISSUES.

2198

MR. WADE: OKAY. OKAY. WELL, LET'S LOOK AT ONE OF THEM. TAKE A LOOK AT 7462.

2199

ADAM ROSENDORFF: I'M SORRY. AGAIN, WHAT VOLUME AND WHAT BINDER?

2200

MR. WADE: EXHIBIT 7462, WHICH SHOULD BE IN THE VOLUME 1 OF THE BLACK BINDER.

2201

ADAM ROSENDORFF: 7462. YES, I HAVE THAT.

2202

MR. WADE: DO YOU HAVE THAT IN FRONT OF YOU?

2204

MR. WADE: AND YOU SEE THAT AS AN EMAIL RELATING TO A QUESTION THAT A DOCTOR POSED TO YOU?

2206

MR. WADE: AND DO YOU SEE THAT?

2208

MR. WADE: OKAY. AND -- I MOVE THE ADMISSION OF 7462.

2209

MR. BOSTIC: NO OBJECTION.

2210

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

2211

(DEFENDANT'S EXHIBIT 7462 WAS RECEIVED IN EVIDENCE.)

2212

BY MR. WADE:

2213

MR. WADE: OKAY. AND WE'LL GO VERY QUICKLY THROUGH THIS. BUT LET'S JUST, TO MAKE SURE EVERYONE IS ON THE SAME PAGE, LET'S JUST GO TO THE LAST EMAIL. DO YOU SEE THAT?

2215

MR. WADE: AND THIS -- AGAIN, WE'VE SEEN MANY OF THESE WHERE THE CUSTOMER SERVICE REPRESENTATIVE FIELDS A CALL?

2217

MR. WADE: AND THIS ONE SAYS THAT THE PARTICULAR DOCTOR IS QUESTIONING THE RESULTS. DO YOU SEE THAT?

2218

ADAM ROSENDORFF: AND HE WOULD LIKE TO BE CALLED ABOUT THE RESULTS, YES.

2219

MR. WADE: AND THIS IS OF A LIPID PANEL?

2221

MR. WADE: AND THIS IS ESCALATED TO YOU IN THE FIRST INSTANCE; CORRECT?

2223

MR. WADE: AND CONTACT INFORMATION IS PROVIDED. DO YOU SEE THAT?

2225

MR. WADE: AND SOME INFORMATION IS GATHERED THROUGHOUT THE COURSE OF THIS EMAIL; CORRECT?

2227

MR. WADE: AND YOU'RE GETTING UP TO SPEED ON THE ISSUE. IS THAT A FAIR SUMMARY OF THE COUPLE OF EMAILS?

2229

MR. WADE: AND LET'S GO TO THE FIRST PAGE. AND AT THE BOTTOM DO YOU SEE IT SAYS NISHIT DOSHI?

2231

MR. WADE: AND LET'S GO OVER TO THE EMAIL THAT CARRIES OVER TO THE NEXT PAGE, JUST THE TOP THERE. HE HAD FORWARDED ALONG SOME OF THESE COMMUNICATIONS. HE SAID, "SUNNY, I AM NOT SURE IF YOU READ THIS ALREADY. "WE ARE CONFIDENT ABOUT OUR LIPID PANEL RESULTS BASED ON THE DAILY RUNS WHERE WE COMPARE FINGERSTICK SAMPLES TO NEAT VENOUS (PREDICATE)." DO YOU SEE THAT?

2233

MR. WADE: THERE WAS A COMPARISON TESTING; RIGHT?

2234

ADAM ROSENDORFF: IT LOOKS THAT WAY.

2235

MR. WADE: YEAH. AND TO ASSURE THE ACCURACY OF THE TEST; RIGHT?

2237

MR. WADE: OKAY. AND IF YOU GO UP TO THE NEXT EMAIL MR. BALWANI FOLLOWS UP WITH YOU?

2239

MR. WADE: AND HE DOESN'T CALL THE DOCTOR DIRECTLY HIMSELF; RIGHT?

2241

MR. WADE: AND HE SAYS, "WE NEED TO CALL THIS DOCTOR AND BE A BIT MORE FIRM ABOUT OUR PERFORMANCE. WE CAN DO A REDRAW, BUT HIS IGNORANT COMMENTS ARE NOT OK. YOU CAN EXPLAIN TO HIM WE RUN THOUSANDS OF SAMPLES AND OUR SAMPLE TRACKING IS VERY TIGHT." DO YOU SEE THAT?

2243

MR. WADE: BUT HE ALSO SAYS THAT, "WE CAN DO A REDRAW FOR NO CHARGE TO THE PATIENT, NO PROBLEMS." RIGHT?

2245

MR. WADE: ULTIMATELY THE PATIENT SUPPOSED TO --

2247

MR. WADE: OKAY. LET'S GO UP TO THE NEXT CHAIN. AND YOU CALLED THE DOCTOR IN FACT; RIGHT?

2249

MR. WADE: AND YOU REPORTED BACK THAT YOU'RE EMPHATIC WITH DR. CHEN REGARDING OUR RIGOROUS VALIDATION AND QUALITY PROCESS; RIGHT?

2251

MR. WADE: AND YOU BELIEVED THAT AT THE TIME; RIGHT?

2253

MR. WADE: AND YOU SAID THAT, "I DID NOT AGREE WITH ANY OF DR. CHEN'S INSINUATIONS." RIGHT?

2255

MR. WADE: AND THEN YOU SAID, "IN MY EXPERIENCE THERE ARE ALWAYS A HANDFUL OF M.D.'S WHO REFUSE TO ACKNOWLEDGE SCIENTIFIC DATA ABOUT THEIR PATIENTS." DO YOU SEE THAT?

2257

MR. WADE: BUT YOU REVIEWED ALL OF THE RELEVANT INFORMATION; RIGHT?

2259

MR. WADE: AND THE CTN IMAGE; RIGHT?

2261

MR. WADE: AND THERE'S A PICTURE OF BLOOD SAMPLE THAT IS TAKEN IN THE MACHINE?

2263

MR. WADE: AND YOU CAN GO AND LOOK AT THAT TO MAKE SURE THE SAMPLE HAS INTEGRITY; RIGHT?

2265

MR. WADE: AND YOU DID THAT?

2267

MR. WADE: AND THOSE WERE CERTAIN IN THE LIS; RIGHT?

2268

ADAM ROSENDORFF: I THINK SO. I DON'T RECALL.

2269

MR. WADE: OKAY. AND YOU LOOKED AT THAT AND YOU LOOKED AT THE QC DATA; RIGHT?

2271

MR. WADE: AND THAT WAS PERFORMING?

2273

MR. WADE: CORRECT? AND SO THAT WAS THE BASIS FOR YOUR COMFORT IN DEFENDING THOSE RESULTS; IS THAT CORRECT?

2275

MR. WADE: OKAY. AND LET'S JUST GO TO THE EMAIL AT THE TOP. AND HE THANKS YOU FOR DOING THIS. HE SAYS HE APPRECIATES IT. AND HE SAYS, "SOME WILL ALWAYS BE DOUBTERS -- HAPPENS WITH NEW TECHNOLOGY." DO YOU SEE THAT?

2277

MR. WADE: AND THIS MIGHT BE A GOOD PLACE TO BREAK, YOUR HONOR.

2278

JUDGE DAVILA: LET'S DO THAT. THANK YOU. LADIES AND GENTLEMEN, WE'LL TAKE OUR NOON -- EXCUSE ME, OUR RECESS FOR THE WEEKEND. WE'LL RESUME AGAIN ON TUESDAY, TUESDAY NEXT AT 9:00 A.M. LADIES AND GENTLEMEN, PLEASE RECALL THE ADMONITION, PLEASE. YOU MUST NOT COMMUNICATE WITH ANYONE IN ANY WAY ABOUT THIS CASE, AND YOU MUST IGNORE ANY INFORMATION ABOUT THE CASE THAT YOU MIGHT SEE WHILE BROWSING THE INTERNET OR ANY OF YOUR SOCIAL MEDIA FEEDS. PLEASE ALSO DO NOT -- PLEASE IGNORE RATHER, PLEASE IGNORE ANY MEDIA THAT YOU MIGHT SEE OR COME ACROSS DURING THE WEEKEND. IF YOU SEE SOMETHING IN THE NEWSPAPER OR THE TELEVISION OR NEWSPAPER OR LISTEN TO SOMETHING, PLEASE TURN AWAY AND TURN THE DEVICE OFF. I'LL ASK YOU AGAIN TUESDAY NEXT WHETHER OR NOT YOU'VE HAD OCCASION TO SUFFER ANY ADDITIONAL INFORMATION ABOUT THE CASE, OTHER THAN WHAT YOU'VE HEARD HERE. OTHER THAN THAT, PLEASE ENJOY THE WEEKEND AND HAVE A GOOD WEEKEND, AND WE'LL SEE YOU NEXT WEEK. THANK YOU. YOU MAY STAND DOWN, DOCTOR. THANK YOU.

2279

(JURY OUT AT 1:01 P.M.)

2280

JUDGE DAVILA: PLEASE BE SEATED. THANK YOU. THANK YOU. THE RECORD SHOULD REFLECT OUR JURY HAS LEFT FOR THE WEEKEND AND DR. ROSENDORFF HAS LEFT THE COURTROOM. ALL COUNSEL AND THE DEFENDANT ARE PRESENT. ANYTHING FURTHER BEFORE WE BREAK?

2281

MR. BOSTIC: VERY BRIEFLY, YOUR HONOR. JUST FOR PLANNING AND HOUSEKEEPING PURPOSES NEXT WEEK, IF WE COULD HAVE AN ESTIMATE AS TO HOW MUCH LONGER THE DEFENSE HAS WITH THIS WITNESS? WE HAVE OUT-OF-TOWN WITNESSES THAT WE'RE TRYING TO PLAN THEIR TRAVEL.

2282

JUDGE DAVILA: SURE. MR. WADE, CAN YOU HELP US WITH THAT QUESTION?

2283

MR. WADE: THE SHORT ANSWER IS YES. THE QUESTION IS WHEN. MR. BOSTIC RAISED THAT. I SUGGEST THAT WE CONFER OVER THE WEEKEND. I UNDERSTAND THAT NEED, AND WE WILL GIVE GUIDANCE. I WOULD EXPECT THAT WE'LL TAKE PROBABLY ALL OF THE DAY ON TUESDAY.

2284

JUDGE DAVILA: OKAY. IS THAT HELPFUL?

2285

MR. BOSTIC: THAT'S HELPFUL TO NOTE, YOUR HONOR. THANK YOU.

2286

JUDGE DAVILA: THANK YOU.

2287

MR. WADE: BUT AS I GO THROUGH I'LL STAY IN COMMUNICATION WITH THE GOVERNMENT ON THAT. I WANT TO MAKE SURE THAT THEY'RE ABLE TO GIVE THEIR WITNESSES AS MUCH NOTICE AS NECESSARY.

2288

JUDGE DAVILA: THANK YOU. I APPRECIATE THAT COOPERATION. PLEASE COMMUNICATE WITH THE COURT THROUGH MS. KRATZMANN IF THERE'S ANY ISSUE THAT COMES UP THAT YOU FEEL YOU WOULD LIKE TO MEET IN ADVANCE OF TUESDAY OR TUESDAY MORNING OR ANY OTHER ISSUE.

2289

MR. WADE: THE GOVERNMENT -- WE'VE BEEN IN CONTINUED COMMUNICATIONS ON THESE ISSUES AND PLEDGE TO HAVE MORE OVER THE WEEKEND. DOES THE COURT HAVE A PREFERENCE IF WE FEEL LIKE ISSUES NEED TO BE RAISED JUST IN THE IMMEDIATE SCHEDULING PERIOD ON MONDAY AND TUESDAY, WOULD THE COURT HAVE A PREFERENCE TO DO THAT ON MONDAY OR TUESDAY?

2290

JUDGE DAVILA: WELL, I THINK OUR CAL -- MS. KRATZMANN, CAN YOU REMIND US OF OUR CALENDAR ON MONDAY? I THINK WE HAVE A MATTER IN THE MORNING.

2291

COURT CLERK: WE HAVE A MATTER IN THE MORNING AT 10:00 AND THEN YOU HAVE THE AFTERNOON PROBABLY FROM 1:30 TO 3:00, 3:15. AFTER THAT YOU WOULD BE AVAILABLE.

2292

MR. WADE: WOULD IT BE THE COURT'S PREFERENCE TO DO IT LATE IN THE AFTERNOON ON MONDAY IF THE GOVERNMENT WANTS TO RAISE ISSUES OR SHOULD WE DO IT IN THE MORNING? EITHER ONE IS FINE BY THE -- FROM THE DEFENSE.

2293

MR. BOSTIC: YOUR HONOR, ON THAT POINT, WE WILL BE GUIDED BY THE COURT. UNLESS THE DEFENSE BELIEVES OTHERWISE, I DON'T THINK THESE ISSUES WILL REQUIRE MORE TIME THAN WOULD BE AVAILABLE TUESDAY MORNING. SO I WOULD SUGGEST THAT WE HANDLE IT TUESDAY MORNING UNLESS THESE ISSUES EXPAND DURING MY CONVERSATIONS WITH MR. WADE OVER THE WEEKEND.

2294

MR. WADE: THAT SOUNDS LIKE A GOOD IDEA. IF WE THINK THERE'S ANY DANGER, WHY DON'T WE ADVISE THE COURT AND COME IN MONDAY AFTERNOON.

2295

JUDGE DAVILA: I APPRECIATE THAT. SO THE DEFAULT WOULD BE WE COULD DO ANYTHING ON TUESDAY, AND IF NOT, YOU FOLKS WILL TALK, AND YOU'LL LET MS. KRATZMANN KNOW, AND WE'LL SCHEDULE ACCORDINGLY.

2296

MR. BOSTIC: YES, YOUR HONOR.

2297

JUDGE DAVILA: GREAT. ALL RIGHT.

2298

MR. WADE: THANK YOU, YOUR HONOR. HAVE A GOOD WEEKEND.

2299

JUDGE DAVILA: HAVE A GOOD WEEKEND.

2300

COURT CLERK: COURT IS ADJOURNED.

2301

(COURT ADJOURNED AT 1:04 P.M.)

← Day 13Rosendorff’s Lab Testimony, Celgene Comparisons, and a Deferred Evidence Dispute1 of 1Day 15 →Rosendorff Cross Ends; Redirect Returns to Edison and HCG Concerns