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Elizabeth Holmes- Case Archive
Federal Criminal TrialtranscripttranscriptAdam Rosendorff — Cross/Redirect (Recall, Continued) - Day 15 - Federal Criminal TrialDefense counsel concluded Adam Rosendorff’s cross-examination before the court limited inquiry into his post-Theranos employment. Redirect then addressed his cooperation with investigators, Edison accuracy concerns, and unresolved HCG testing problems.
John C. BosticRobert S. LeachKevin M. DowneyLance A. WadeEdward J. DavilaAdam RosendorffJudge DavilaMr. WadeAdam RosendorffCourt ClerkMr. BosticMr. DowneyMr. Leachcrossproceduralredirect
Federal Criminal Trial/Day 15/October 5, 2021
2 pages·1 witness·2,631 lines
Defense counsel concluded Adam Rosendorff’s cross-examination before the court limited inquiry into his post-Theranos employment. Redirect then addressed his cooperation with investigators, Edison accuracy concerns, and unresolved HCG testing problems.
← Day 14
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CrossRedirect

Adam Rosendorff — Cross/Redirect (Recall, Continued)

John C. Bostic Lance A. Wade Adam Rosendorff
2,471 lines
Proceedings
Cross 1Adam Rosendorff — CrossLine 9
Procedural 1Evidentiary Hearing on Rosendorff's Post-Theranos EmploymentLine 24
Cross 2Adam Rosendorff — Cross ResumedLine 5
RedirectAdam Rosendorff — RedirectLine 7
Procedural 2Evening Jury Admonition and SchedulingLine 4
Cross 1Cross 1 Adam Rosendorff Lance A. Wade
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JUDGE DAVILA: ALL RIGHT. GOOD MORNING. WE'RE BACK ON THE RECORD IN THE HOLMES MATTER. ALL COUNSEL IS PRESENT. MS. HOLMES IS PRESENT. DR. ROSENDORFF IS ON THE STAND. GOOD MORNING, LADIES AND GENTLEMEN OF OUR JURY. IT'S NICE TO SEE YOU AGAIN. I APOLOGIZE FOR THE DELAY. I NEEDED SOME ASSISTANCE FROM THE LAWYERS THIS MORNING ON SOME ISSUES. BEFORE WE BEGIN THE CONTINUED EXAMINATION DR. ROSENDORFF, I DO NEED TO ASK YOU, OVER THE LONG WEEKEND, LADIES AND GENTLEMEN, HAVE ANY OF YOU HAD OCCASION TO COME ACROSS, BE EXPOSED TO OR SPEAK ABOUT THIS CASE, ANY OF THE PARTIES OR ANYTHING TO DO WITH THIS CASE IN ANY FASHION? HAS ANYONE HAD THAT EXPERIENCE? AGAIN, IF YOU WANT TO SPEAK PRIVATELY, WE CAN DO THAT. I SEE NO HANDS. THANK YOU VERY MUCH. MR. WADE, YOU HAVE QUESTIONS?

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

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JUDGE DAVILA: DOCTOR, IF YOU COULD JUST STATE YOUR NAME, PLEASE.

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ADAM ROSENDORFF: ADAM ROSENDORFF.

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JUDGE DAVILA: THANK YOU. AND I'LL REMIND YOU, SIR, YOU'RE STILL UNDER OATH.

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ADAM ROSENDORFF: THANK YOU.

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JUDGE DAVILA: YOU'RE WELCOME.

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

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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 ASK YOU SOME MORE QUESTIONS ABOUT SOME OF THE ASSAYS THAT YOU TESTIFIED ABOUT ON DIRECT EXAMINATION.

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MR. WADE: AND BEFORE I DO THAT, I WOULD JUST -- WE -- YOU GAVE SOME TESTIMONY ABOUT YOUR INTERACTIONS WITH THE GOVERNMENT; CORRECT?

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MR. WADE: AND THE MEETINGS THAT YOU HAD IN ADVANCE OF YOUR TESTIMONY?

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MR. WADE: THREE MEETINGS; CORRECT?

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MR. WADE: AND I JUST WANT TO MAKE A COUPLE OF POINTS CLEAR. IN THOSE MEETINGS, YOU DIDN'T DECIDE WHICH DOCUMENTS YOU WOULD LOOK AT; CORRECT? THEY SHOWED YOU DOCUMENTS?

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MR. WADE: AND THEY CHOSE WHICH ONES TO ASK YOU QUESTIONS ABOUT?

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MR. WADE: OKAY. AND IN YOUR DIRECT EXAMINATION, YOU DIDN'T DECIDE THE ORDER IN WHICH YOU WOULD GO THROUGH THE DOCUMENTS; CORRECT?

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MR. WADE: THE GOVERNMENT FOCUSSED YOU ON SPECIFIC PORTIONS OF DOCUMENTS AND ASKED YOU QUESTIONS ABOUT THAT?

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MR. WADE: I WANT TO LOOK AT A FEW OF THOSE DOCUMENTS. SPECIFICALLY I WANT TO TURN TO HDL. AND I'M GOING -- DO YOU RECALL THAT YOU GAVE SOME TESTIMONY ABOUT HDL?

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MR. WADE: OKAY. AND YOU TALKED ABOUT AN HDL ISSUE THAT AROSE IN FEBRUARY OF 2014. DO YOU RECALL THAT?

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ADAM ROSENDORFF: I DON'T RECALL THE EXACT DATE.

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MR. WADE: WELL, LET ME PULL UP THE DOCUMENT. IT'S EXHIBIT 1543. IT'S IN EVIDENCE AND WE'LL PUT -- WE'LL PUT THE PORTION OF THE DOCUMENT THAT YOU WERE ASKED ABOUT BY THE GOVERNMENT UP ON TO THE SCREEN. DO YOU SEE UP ON THE SCREEN TWO PORTIONS OF THE DOCUMENT 1543? AND THE ENTIRE DOCUMENT I BELIEVE IS IN THE WHITE BINDER. FEEL FREE TO LOOK AT IT ANY TIME.

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MR. WADE: SHOULD WE WAIT A SECOND, YOUR HONOR?

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COURT CLERK: MY APOLOGIES, BUT IT WAS POINTING TO THE CEILING, YOUR HONOR. MY APOLOGIES, COUNSEL.

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MR. WADE: MY BEST ANGLE.

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MR. WADE: DO YOU HAVE 1543 IN FRONT OF YOU, SIR?

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MR. WADE: OKAY. AND DO YOU RECALL BEING QUESTIONED BY THE GOVERNMENT ABOUT THESE PORTIONS OF THE DOCUMENTS?

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MR. WADE: AND IT WAS A PRETTY LENGTHY SERIES OF QUESTIONS. YOU WERE ASKED ABOUT THE CAUSE OF THIS ISSUE. DO YOU RECALL THAT?

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MR. WADE: AND YOU SAID THAT YOU SUSPECTED IT WAS A PROBLEM WITH THE ASSAY; RIGHT?

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MR. WADE: OKAY. AND THEY ASKED YOU ABOUT THE SPATE -- DO YOU SEE UP THERE, THE SPATE OF LOW HDL VALUES?

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MR. WADE: AND THEY TALKED ABOUT HOW YOU NOTED IN THERE THAT THE ASSAY HAD FAILED; RIGHT?

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ADAM ROSENDORFF: I SAID I SUSPECT THAT OUR HDL ASSAY HAD FAILED.

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MR. WADE: RIGHT. AND THAT'S THE TESTIMONY THAT THE GOVERNMENT ELICITED. DO YOU RECALL THAT? DO YOU RECALL QUESTIONS ABOUT THE FACT THAT THE ASSAY HAD FAILED?

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MR. WADE: AND THAT YOU ACTUALLY DESCRIBED SOME CIRCUMSTANCES RELATING TO THAT THAT ARE REFERENCED IN THESE PORTIONS OF THE EXHIBITS RELATING TO QC. DO YOU RECALL THAT?

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MR. WADE: THIS HAD ACTUALLY PASSED QC AND THE GOVERNMENT ASKED IF THIS WAS AN OCCASION WHERE QC COULD PASS BUT THERE WOULD STILL BE A PROBLEM. DO YOU RECALL THAT?

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MR. WADE: AND YOU SAID YES; RIGHT?

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MR. WADE: AND THEY ASKED YOU ABOUT TECAN USAGE. DO YOU RECALL THAT?

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ADAM ROSENDORFF: NOT SPECIFICALLY, NO.

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MR. WADE: AND THEY ASKED YOU ABOUT THE CTN PROBLEM THAT IS IDENTIFIED THERE. DO YOU SEE THAT?

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MR. WADE: OKAY. THEY ASKED YOU ABOUT THAT AND THEY ASKED YOU WHETHER THIS -- YOU THOUGHT THIS WAS A BASIS FOR THE PROBLEM; RIGHT?

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MR. WADE: AND YOU SAID YOU THOUGHT IT WAS; RIGHT?

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MR. WADE: AS REFLECTED IN THE EMAIL?

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MR. WADE: AND THEY NOTED, THE GOVERNMENT NOTED THAT THERE WERE NO CTN'S USED ON COMMERCIAL ASSAYS; RIGHT?

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MR. WADE: OKAY. AND THEN THEY ASKED YOU ABOUT THE FACT THAT THIS WAS SENT TO MS. HOLMES. DO YOU RECALL THAT? ACTUALLY THEY SWITCHED DOCUMENTS. AT THIS POINT I THINK THEY SWITCHED TO 1555. LET'S PULL THAT UP. AND LET'S FOCUS ON THAT PIECE THERE. DO YOU RECALL THAT THEY NOTED THAT YOU RAISED THIS WITH MS. HOLMES? DO YOU RECALL THAT?

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MR. WADE: AND THEY ASKED YOU WHY, AND YOU TESTIFIED THAT YOU THOUGHT IT WAS IMPORTANT BECAUSE THAT WOULD BE SURE TO GET THE ATTENTION; RIGHT?

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MR. WADE: AND THERE WAS A SUGGESTION THAT MAYBE MR. BALWANI AND DR. YOUNG MIGHT BE RELUCTANT WITHOUT MS. HOLMES BEING INVOLVED; RIGHT? DO YOU RECALL THAT?

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ADAM ROSENDORFF: I THOUGHT IT WAS IMPORTANT THAT ELIZABETH WAS AWARE OF THESE ISSUES AS THE CEO OF THE COMPANY.

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MR. WADE: AND I BELIEVE YOU TESTIFIED SOMETHING TO THE EFFECT OF IT WOULD ENSURE THAT THE APPROPRIATE RESOURCES WOULD BE DEVOTED TO IT; RIGHT? DO YOU RECALL THAT?

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ADAM ROSENDORFF: I DON'T RECALL THAT SPECIFICALLY, NO.

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MR. WADE: OKAY. AND SO IF I CAN TAKE THAT DOWN AND PUT THE ELMO UP IF I COULD.

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COURT CLERK: IS THIS ADMITTED?

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MR. WADE: IT'S JUST A DEMONSTRATIVE THAT I NORMALLY WOULD PUT ON A WHITE BOARD, YOUR HONOR, BUT I WANT EVERYONE TO SEE IT. IF WE CAN ZOOM --

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MR. BOSTIC: YOUR HONOR, THE GOVERNMENT COUNSEL HAS NOT SEEN THIS DEMONSTRATIVE YET.

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MR. WADE: I WOULD PUT IT ON A WHITE BOARD. I NORMALLY DON'T SHOW MY WHITE BOARD, BUT I'M HAPPY TO GIVE --

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JUDGE DAVILA: IF YOU HAVE A COPY, I'M SURE MR. BOSTIC WOULD WELCOME IT.

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BY MR. WADE:

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MR. WADE: SO THIS JUST SUMMARIZED WHAT WE TALKED ABOUT. THE QC PASSED, BUT THE GOVERNMENT ELICITED TESTIMONY THAT THAT DID NOT PROVIDE PROTECTION IN THIS CIRCUMSTANCE?

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MR. WADE: AND THIS WAS A THERANOS ASSAY PROBLEM THAT YOU THOUGHT AT THE TIME; RIGHT?

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MR. WADE: AND THAT THERE WAS A CTN PROBLEM; RIGHT?

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MR. WADE: AND THAT DIDN'T RELATE TO -- THAT WOULDN'T BE PRESENT IF THERE WAS A COMMERCIAL MACHINE?

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MR. WADE: AND MAYBE MR. BALWANI AND DR. YOUNG MAY BE RELUCTANT TO ADDRESS THAT, AND SO YOU RAISED IT TO MS. HOLMES; RIGHT?

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ADAM ROSENDORFF: I REMEMBER TESTIFYING THAT I THOUGHT IT WAS IMPORTANT THAT ELIZABETH WAS AWARE OF THESE ISSUES.

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ADAM ROSENDORFF: I DID, I DID FACE PUSHBACK FROM MR. BALWANI AND DR. YOUNG FREQUENTLY ABOUT THESE ISSUES, YEAH.

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MR. WADE: AND SOMETIMES THEY WERE RELUCTANT; RIGHT?

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MR. WADE: OKAY. NOW -- AND THEN AFTER THE GOVERNMENT WENT THROUGH THAT TESTIMONY, THEY MOVED ON TO A DIFFERENT ASSAY. DO YOU RECALL THAT?

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ADAM ROSENDORFF: I DON'T RECALL WHICH ASSAY THEY MOVED ON TO.

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MR. WADE: OKAY. NONE OF THESE ISSUES IS TRUE, RIGHT, SIR, WITH RESPECT TO HDL IN FEBRUARY OF 2014? IT WAS NOT AN ISSUE WHERE QC PASSED; RIGHT? QC FAILED. DO YOU RECALL THAT?

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ADAM ROSENDORFF: NO. I RECALL THAT QC WAS 10 PERCENT BELOW HOW IT HAD BEEN TRENDING AND THAT WAS WITHIN THE ACCEPTABILITY CRITERIA.

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MR. WADE: OKAY. WE'LL GET TO THAT. AND IT WAS NOT THE CASE THAT IT WAS A THERANOS ASSAY PROBLEM, IT WAS ACTUALLY AN ISSUE WITH VARIABILITY BETWEEN TWO COMMERCIAL MACHINES, WAS IT NOT?

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ADAM ROSENDORFF: THERE WAS A SMALL AMOUNT OF VARIABILITY BETWEEN TWO COMMERCIAL MACHINES THAT WAS GREATLY EXACERBATED WHEN THOSE MACHINES WERE MODIFIED FOR THE THERANOS METHOD.

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MR. WADE: AND IT WAS NOT --

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ADAM ROSENDORFF: AND THAT'S WHAT THE DATA WILL REFLECT.

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MR. WADE: AND IT WAS NOT A CTN PROBLEM; RIGHT?

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ADAM ROSENDORFF: IT COULD HAVE BEEN.

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MR. WADE: OKAY. WELL, WE'LL TALK ABOUT WHAT ACTUALLY HAPPENED, BECAUSE THE GOVERNMENT DIDN'T ACTUALLY GO THROUGH WHAT ACTUALLY HAPPENED AND FOLLOW UP ON THAT, DID THEY?

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MR. WADE: THEY DIDN'T SHOW YOU THOSE DOCUMENTS, DID THEY?

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ADAM ROSENDORFF: WHICH DOCUMENTS?

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MR. WADE: THE DOCUMENTS THAT FOLLOW UP ON THIS. THEY DIDN'T SHOW YOU A PIECE OF THE DOCUMENTS THAT WOULD ADDRESS THOSE ISSUES. LET'S LOOK AT THEM. LET'S GO TO 1543. AND IF WE CAN SWITCH. LET'S GO TO THE SECOND PAGE. DO YOU SEE IN THE MIDDLE THERE YOU RAISE THE ISSUE; RIGHT? DO YOU SEE THAT?

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MR. WADE: AND YOU'RE DIGGING IN ON THE ISSUE, AND YOU'RE RAISING IT WITH DR. YOUNG AND YOU'RE RAISING IT WITH MR. BALWANI; RIGHT?

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MR. WADE: AND THIS IS THE SAME EXHIBIT THAT THE GOVERNMENT WAS EXAMINING YOU ABOUT, BUT JUST DIFFERENT PORTIONS OF IT; RIGHT?

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MR. WADE: AND THEY RAISE THAT ISSUE AT 2:37; CORRECT?

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MR. WADE: AND LET'S GO TO THE NEXT PAGE SO YOU CAN SEE THE DATE AND TIME OF MR. BALWANI'S RESPONSE. IT WAS TWO MINUTES LATER; RIGHT?

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ADAM ROSENDORFF: I SEE THE ORIGINAL EMAIL AND IT WAS 2:37 P.M. THE NEXT EMAIL FROM MR. BALWANI IS 2:39 P.M.

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MR. WADE: DO YOU SEE -- SO TWO MINUTES LATER HE RESPONDED?

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MR. WADE: AND THAT DOESN'T LOOK LIKE RELUCTANCE, DOES IT?

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ADAM ROSENDORFF: I'M REFERRING TO RELUCTANCE WHEN I HAD MY DISCUSSIONS, MY PERSONAL DISCUSSIONS WITH HIM.

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MR. WADE: LET'S LOOK AT THE SUBSTANCE OF THE EMAIL. DO YOU SEE THERE IT SAYS, DANIEL, CAN YOU HAVE NISHIT AND TINA LEAD AN INVESTIGATION ON THIS? DO YOU SEE THAT?

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MR. WADE: AND TWO MINUTES LATER HE SAID THAT; RIGHT?

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MR. WADE: AND THEN HE COPIED YOU IN AND SAYS HE'S NOT SURE WHY THIS WOULD BE A CTN ISSUE, BUT HE'S HAPPY TO LOOK AT IT; RIGHT?

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MR. WADE: OKAY. AND THE GOVERNMENT DIDN'T YOU ASK ABOUT THAT PIECE OF THE DOCUMENT WHEN THEY WERE ASKING YOU ABOUT THAT, DID THEY?

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MR. WADE: AND LET'S GO TO THE PORTION OF THE DOCUMENT -- LET'S GO TO THE OTHER DOCUMENT THAT THE GOVERNMENT SHOWED YOU, 1555. OKAY? DO YOU HAVE THAT DOCUMENT IN FRONT OF YOU? IT'S IN THE WHITE BINDER, 1555.

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MR. WADE: AND LET'S GO, LET'S GO TO THE END FIRST. AND THIS BOTTOM EMAIL IS THE EMAIL IN WHICH YOU RAISE THE ISSUE; RIGHT?

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MR. WADE: AND THAT'S THE PORTION OF THE DOCUMENT THAT THE GOVERNMENT ASKED YOU ABOUT; RIGHT?

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MR. WADE: OKAY. LET'S GO UP TO THE NEXT EMAIL. DO YOU SEE THAT?

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MR. WADE: AND IT SAYS, "ADAM, CAN WE COMPLETE A MINI-STUDY TOMORROW MORNING?" DO YOU SEE THAT?

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MR. WADE: AND HE RESPONDED THE SAME DAY, AN HOUR OR SO LATER?

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MR. WADE: AND HE WANTS TO ADDRESS IT RIGHT AWAY; RIGHT?

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MR. WADE: OKAY. HE THEN SAYS HE PULLED SOME DATA, DO YOU SEE THAT, AND HE'S STARTING TO LOOK AT IT ALREADY?

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MR. WADE: AND INCLUDING THE CTN ISSUE?

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ADAM ROSENDORFF: WELL, HE COMPARED CTN'S TO STANDARD PROTOCOL USING VENOUS SAMPLES.

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MR. WADE: RIGHT. BUT YOU SAID IT MIGHT BE A CTN ISSUE --

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ADAM ROSENDORFF: IT COULD HAVE BEEN, YES.

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MR. WADE: AND HE'S LOOKING AT DATA RELATING TO WHETHER IT'S A CTN ISSUE; RIGHT?

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ADAM ROSENDORFF: HE'S LOOKING AT HISTORICAL DATA.

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MR. WADE: ON CTN'S?

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MR. WADE: RIGHT AWAY?

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ADAM ROSENDORFF: HISTORICAL DATA, PREVIOUS DATA.

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MR. WADE: TO ASSESS WHETHER IT SUGGESTED IT WAS A CTN PROBLEM; RIGHT?

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ADAM ROSENDORFF: SO IN THE CTN'S THERE'S DIFFERENT AMOUNTS OF ANTICOAGULANT THAT IS SPRAYED ON TO THE CTN'S THAT COULD IMPACT AN HDL MEASUREMENT. THAT MANUFACTURING PROCESS WAS NOT STANDARDIZED AT THERANOS. SO JUST BECAUSE IT LOOKS GOOD IN RUN TIME PERIOD, IT DOESN'T GUARANTEE IT'S GOING TO LOOK GOOD IN A SUBSEQUENT TIME PERIOD.

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MR. WADE: I UNDERSTAND, SIR. BUT MY POINT IS THAT YOU RAISED THAT IT COULD BE A CTN ISSUE AND THEY WERE LOOKING AT DATA RELATING TO CTN'S; RIGHT?

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MR. WADE: OKAY. AND LET'S GO, LET'S GO UP AND GET THE NEXT TWO EMAILS IN THE CHAIN. YOU'RE WORKING TOGETHER AND YOU'RE ATTACKING THE PROBLEM; RIGHT?

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MR. WADE: OKAY. AND THE STUDY WAS GOING TO START THE NEXT MORNING; RIGHT?

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MR. WADE: OKAY. IN FACT, DR. YOUNG -- YOU RAISED -- THE GOVERNMENT ASKED IF THIS WAS AN INDICATION OF WHERE QC CAN PASS AND THERE IS STILL A PROBLEM; RIGHT?

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MR. WADE: OKAY. AND YOU SAID YES. BUT DR. YOUNG HAD ALREADY PULLED THE QC DATA; RIGHT?

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ADAM ROSENDORFF: SO THE QC SAMPLES DO NOT GO INTO A CTN, JUST TO CLARIFY. SO IF THERE'S A PROBLEM WITH THE CTN, THAT WOULD NEVER BE REFLECTED IN THE QC.

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MR. WADE: SIR, MY POINT IS THAT THE GOVERNMENT ASKED YOU -- YOU NOTED THE QC PASSED; RIGHT?

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MR. WADE: AND THAT'S THE DAILY QC; CORRECT?

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MR. WADE: AND THEY ASKED YOU, IS THIS AN INDICATION WHERE QC CAN PASS AND THERE CAN STILL BE A PROBLEM WITH THE ASSAY, AND YOU SAID YES?

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ADAM ROSENDORFF: THAT'S CORRECT.

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MR. WADE: DO YOU RECALL THAT?

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MR. WADE: YEAH. BUT, IN FACT, DR. YOUNG PULLED THE HISTORICAL LEVEY-JENNINGS DATA AND HE FOUND THAT THE QC HAD ACTUALLY FAILED, BUT THAT YOUR STAFF HAD NOT CAUGHT THAT QC FAILURE; CORRECT?

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ADAM ROSENDORFF: WE HAD DISCUSSED IMPLEMENTING LEVEY-JENNINGS PROCEDURES. IT HAD NOT BEEN FORMALIZED IN AN SOP.

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MR. WADE: LET'S GO TO 1541. THAT'S IN THE GOVERNMENT'S BOOK. DO YOU HAVE THAT?

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JUDGE DAVILA: HAS THIS BEEN ADMITTED?

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ADAM ROSENDORFF: I DON'T HAVE IT, SIR.

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MR. WADE: YOU DON'T HAVE 1541?

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MR. WADE: THE COURT'S INDULGENCE FOR ONE SECOND.

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MR. WADE: LOOK IN BLACK EXHIBIT BINDER, VOLUME 1. IT SHOULD BE ABOUT THE FOURTH DOCUMENT.

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MR. WADE: OKAY. AND THIS IS AN EMAIL BETWEEN YOU, MR. BALWANI, DR. PANDORI, AND DR. YOUNG ON THE SAME SUBJECT?

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MR. WADE: MOVE TO ADMIT 1541.

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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 1541 WAS RECEIVED IN EVIDENCE.)

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BY MR. WADE:

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MR. WADE: AND THE GOVERNMENT DIDN'T ASK YOU QUESTIONS ABOUT THIS ON YOUR DIRECT TESTIMONY; CORRECT?

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MR. WADE: LET'S GO TO THIRD PAGE AND GRAB THE BOTTOM HALF.

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MR. WADE: DO YOU SEE THAT?

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MR. WADE: AND DO YOU SEE THAT'S AN INDICATION THAT, JUST AS YOU WERE RAISING THIS ISSUE, DR. YOUNG GRABBED THE QC RESULTS TO LOOK AT THE HDL QC RESULTS AND HE SAID THIS SHOULD HAVE RAISED AN ALARM SEVERAL WEEKS AGO; RIGHT?

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ADAM ROSENDORFF: THAT'S DANIEL YOUNG'S ASSERTION.

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MR. WADE: OKAY. WELL, DID YOU AGREE WITH THAT ASSERTION OR NOT?

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ADAM ROSENDORFF: NO. IF THE QC PASSES, THE TEST IS CLEARED FOR PATIENT USE.

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MR. WADE: IT'S CLEARED FOR PATIENT USE AT THAT POINT, BUT YOU NEED TO GO BACK AND LOOK. DO YOU RECALL THE TESTIMONY THAT YOU NEED TO GO AND LOOK AT THE LEVEY-JENNINGS DATA AND LOOK AT THE WESTGARD RULES AND LOOK AT THE TRENDS OVER TIME AND SEE WHAT THE TRENDS LOOK LIKE OVER TIME?

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ADAM ROSENDORFF: MR. WADE, THERE ARE A NUMBER OF WESTGARD RULES THAT RELY ON STANDARD DEVIATIONS AND A SERIES OF STANDARD DEVIATIONS FALLING ON ONE OR OTHER SIDE OF A MEAN. IT'S A COMPLICATED SET OF RULES. WE DISCUSSED THEM MANY TIMES AND THEY WERE NOT IMPLEMENTED IN THE LABORATORY.

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MR. WADE: LET'S LOOK AT YOUR EMAIL ON THIS, ON THE SECOND PAGE ON THE BOTTOM. LET'S BLOW THAT UP. THIS IS YOUR EMAIL, RIGHT, SIR?

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MR. WADE: AND THIS IS IN RESPONSE TO THIS QC DATA; RIGHT?

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MR. WADE: AND YOU'RE COPIED IN ON THE FACT THAT THE QC'S SHOULD HAVE CAUGHT THIS ISSUE WEEKS AGO; RIGHT?

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MR. WADE: OKAY. AND YOU WRITE THAT YOU REVIEWED THE DATA REGULARLY; RIGHT?

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MR. WADE: AND THAT YOU WERE LOOKING AT LEVEY-JENNINGS QC --

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MR. WADE: RIGHT?

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MR. WADE: AND YOU WERE LOOKING AT THOSE COMPLICATED RULES?

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MR. WADE: BUT ESSENTIALLY THIS WAS MISSED; RIGHT?

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ADAM ROSENDORFF: IT WAS NOT PART OF OUR FORMAL PROCEDURE.

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MR. WADE: OKAY. BUT IT SHOULD HAVE BEEN UNDER YOUR POLICY; RIGHT?

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ADAM ROSENDORFF: I DON'T BELIEVE SO.

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MR. WADE: OKAY. SO WHEN THE GOVERNMENT SAID THIS IS AN ISSUE WHERE THE QC PASSED, THE QC, AS DR. YOUNG NOTES, APPLYING YOUR POLICY SAID THAT IT SHOULD HAVE RAISED THE ISSUE A LONG TIME AGO, BUT YOU JUST FAILED TO CATCH IT; RIGHT?

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ADAM ROSENDORFF: I'M SORRY. COULD YOU POINT ME TO THE POLICY REGARDING THE WESTGARD RULES, REFRESH MY MEMORY ON THAT.

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MR. WADE: WELL, YOU RECALL THAT YOU FOLLOWED WESTGARD RULES; RIGHT?

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ADAM ROSENDORFF: NO. WE DISCUSSED THEM ON MANY OCCASIONS, BUT THEY WERE NOT IMPLEMENTED IN THE LABORATORY.

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MR. WADE: YOU NEVER FOLLOWED THE WESTGARD RULES?

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ADAM ROSENDORFF: WE DISCUSSED WITH A NUMBER OF PEOPLE THE APPROPRIATENESS OF APPLYING WESTGARD RULES TO QC DATA. IT WAS NOT SIGNED OFF AS PART OF A FORMAL POLICY.

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MR. WADE: WELL, YOU WERE RESPONSIBLE FOR THE POLICY. DID YOU OR DID YOU NOT IMPLEMENT WESTGARD RULES?

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ADAM ROSENDORFF: WE DID NOT.

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MR. WADE: DO YOU SEE HERE IT SAYS, "LOOKING AT LEVEY-JENNINGS QC FOR JANUARY AND FEBRUARY SO FAR, INDEED WE WOULD HAVE FAILED WESTGARD BASED ON THE 10 1S RULE FOR LEVEL 1 AT LEAST." DO YOU SEE THAT?

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MR. WADE: AND THEN DO YOU SEE DOWN BELOW IT SAYS, "I HAVE BEEN ASKING THE SUPERVISORS TO COLLECT THE ADVIA QC DATA AND PRESENT IT TO ME MONTHLY SINCE OUR CLIA INSPECTION." DO YOU SEE THAT?

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MR. WADE: BECAUSE THESE ARE ISSUES THAT COME UP IN THE CLIA INSPECTION; RIGHT?

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ADAM ROSENDORFF: I DON'T RECALL.

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MR. WADE: AND THAT WAS ONE OF THE ISSUES THAT MS. HOLMES AND MR. BALWANI WERE UNHAPPY THAT THERE WAS AN ISSUE; RIGHT?

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ADAM ROSENDORFF: THEY EXPECTED THERE TO BE NO DEFICIENCIES.

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MR. WADE: AND I ASSUME IF YOU EXPECTED THERE WAS ONE, YOU WOULD HAVE ADDRESSED IT; RIGHT?

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MR. WADE: AND IT SAYS, "IT SEEMS THIS IS NOT HAPPENING." DO YOU SEE THAT?

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MR. WADE: AND THOSE ARE YOUR WORDS; RIGHT, SIR?

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MR. WADE: AND WHEN IT SAYS THIS IS NOT HAPPENING, IT'S YOUR BELIEF AT THIS TIME THAT THAT SHOULD BE HAPPENING; RIGHT?

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MR. WADE: AND YOU SAY, "I WILL IMPRESS UPON THEM THE IMPORTANCE OF COLLECTING THIS DATA." RIGHT?

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MR. WADE: OKAY. AND SO THE QC POLICY AND THE PRACTICES THAT YOU THOUGHT SHOULD HAVE BEEN HAPPENING WOULD HAVE CAUGHT THIS; RIGHT?

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ADAM ROSENDORFF: AGAIN, I'D LIKE TO REVIEW THE QC POLICY TO SEE WHAT WAS FORMALLY IMPLEMENTED. ANOTHER THING THAT I'LL ADD IS THAT I'M NOT QUITE SURE WHAT MY MEANING HERE IS IN TERMS OF THE MONTHLY QC. I WAS REVIEWING THAT WITH LANGLY GEE ON A MONTHLY BASIS.

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MR. WADE: SIR, YOU SAY RIGHT HERE THAT WHAT YOU WERE EXPECTING TO HAPPEN WAS NOT HAPPENING; RIGHT?

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MR. WADE: AND YOU SAY THAT YOU WERE GOING TO IMPRESS UPON THEM THE IMPORTANCE OF DOING THAT AS A RESULT OF THIS ISSUE; RIGHT?

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MR. WADE: OKAY. NOW, SIR, IF YOU GO UP THE CHAIN TO THE NEXT EMAIL -- AND JUST SO WE'RE ALL CLEAR, WHEN THIS ISSUE IS BEING RAISED, THERE ARE NOT TESTS GOING OUT, RIGHT? YOU PUT A PAUSE ON THE TEST, ON THE RESULTS?

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ADAM ROSENDORFF: I BELIEVE I COMMUNICATED TO MANAGEMENT THAT THE LIPID TEST SHOULD HAVE GONE ONTO A VACUTAINER AT THIS TIME.

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MR. WADE: RIGHT. AND YOU HELD THE RESULTS UNTIL YOU FIGURED OUT WHAT WAS GOING ON?

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MR. WADE: AND THEN EVERYONE, IT LOOKS LIKE ON FRIDAY AND GOING FORWARD, IS WORKING REALLY HARD TO FIGURE OUT WHAT THE ISSUE IS; RIGHT?

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MR. WADE: OKAY. INCLUDING DR. YOUNG AND MR. BALWANI?

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ADAM ROSENDORFF: I DON'T KNOW WHAT THEY WERE DOING DURING THIS TIME PERIOD.

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MR. WADE: TAKE A LOOK AT THE EMAILS UP AND DOWN THIS CHAIN. THEY'RE ENGAGED ACTIVELY DURING THIS PERIOD, ARE THEY NOT?

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

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MR. WADE: CAN YOU LOOK AT THE DATES ON THE EMAIL AND TELL ME WHETHER YOU CAN INFER FROM THAT WHETHER THEY WERE WORKING ACTIVELY AT THIS TIME?

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ADAM ROSENDORFF: I WOULD BE SPECULATING.

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MR. WADE: OKAY. IF WE GO UP TO MR. PANDORI'S EMAIL, DO YOU SEE THAT, HE ACTUALLY DISCUSSED THAT HE HAD ASSIGNED THIS QC PROJECT FOR SOMEONE TO IMPLEMENT; RIGHT?

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MR. WADE: OKAY. AND SO THE POLICY SHOULD HAVE GOT THIS?

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ADAM ROSENDORFF: AGAIN, I'M NOT SURE OF THE DETAILS OF THE POLICY THAT YOU'RE REFERENCING SO I CAN'T REALLY COMMENT.

277

MR. WADE: OKAY. LET'S GO UP ONE MORE AND SEE IF WE CAN BRING YOU TO THAT. DR. YOUNG SAYS ON THE BOTTOM, "REGARDING WESTGARD RULES -- I THINK THERE IS SOME CONFUSION. THERE ARE ACTUALLY TWO RULES THAT I THINK OUR QC DATA FAILED." DO YOU SEE THAT?

279

MR. WADE: AND LET'S GO TO THE NEXT PAGE. HE LOOKS AT THAT DATA AND HE LAYS OUT THOSE RULES; RIGHT?

281

MR. WADE: OKAY. AND THEN AT THE BOTTOM HE SAYS, "I'M LOOKING INTO OTHER POTENTIAL CAUSES FOR THE LOW HDL VALUES."

283

MR. WADE: DO YOU SEE THAT? AND SO THEY'RE LOOKING AT ANY ISSUE; RIGHT?

285

MR. WADE: INCLUDING REAGENTS OR CALIBRATION?

287

MR. WADE: AND EVERYONE WAS TRYING TO ADDRESS THIS; RIGHT?

288

ADAM ROSENDORFF: IT APPEARS THAT DANIEL WAS TRYING TO ADDRESS THIS AT THIS TIME.

289

MR. WADE: OKAY. OKAY. LET'S GO UP TO THE FIRST PAGE. MR. BALWANI AS WELL, RIGHT, IS SAYING WE SHOULD TRY NEW REAGENTS AND SEE IF THAT IS THE ISSUE BECAUSE IF THAT'S A POSSIBLE CAUSE; CORRECT?

291

MR. WADE: AND LET'S GO TO THE NEXT EMAIL. DO YOU SEE THAT?

293

MR. WADE: THERE'S A SUGGESTION, LET'S LOOK AT EVEN MORE QC DATA TO SEE IF THAT SHEDS ANY LIGHT; RIGHT?

294

ADAM ROSENDORFF: RIGHT. SO WHAT DANIEL IS SAYING IS THAT THE -- MY EMAIL ABOUT THE 1 SD RULING -- FAILING WAS BASED ON DATA FROM OCTOBER TO DECEMBER OF 2013, AND DANIEL WAS LOOKING AT DIFFERENT DATA FROM JANUARY 2ND, 2014 TO FEBRUARY 18TH, 2014.

295

MR. WADE: AND, IN FACT, LET'S GO TO EXHIBIT 1556, WHICH SHOULD BE IN YOUR BLACK BOOK, VOLUME 1.

297

MR. WADE: OKAY. THIS IS ANOTHER EMAIL THAT INVOLVES YOU AND OTHERS RELATING TO THIS ISSUE; CORRECT?

299

MR. WADE: MOVE THE ADMISSION OF 1556.

300

MR. BOSTIC: NO OBJECTION.

301

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

302

(GOVERNMENT'S EXHIBIT 1556 WAS RECEIVED IN EVIDENCE.)

303

MR. WADE: AND IF WE CAN BLOW UP THE TOP HALF.

304

MR. WADE: THIS EMAIL WITH MR. HAASE --

306

MR. WADE: -- REFLECTS THAT THERE IS EVEN MORE ANALYSIS BEING DONE IN THIS PERIOD; RIGHT?

308

MR. WADE: AND DO YOU RECALL FROM THE EMAIL AT THE TOP THERE WERE ISSUES THAT CAME UP AS TO WHETHER THIS MIGHT BE AN ISSUE WITH RESPECT TO VARIABILITY IN THE ADVIA'S?

309

ADAM ROSENDORFF: SUNNY IS RAISING THAT ISSUE.

312

MR. WADE: AND DO YOU RECALL INVESTIGATING THAT ISSUE DURING THIS TIME PERIOD?

313

ADAM ROSENDORFF: THERE WAS A STUDY LOOKING AT VENOUS AND FINGERSTICK LIPIDS ON THE TWO DIFFERENT ADVIA'S AND COMPARING THE BIAS USING THE TWO DIFFERENT METHODS. THERE WAS A LONG DISCUSSION OF THAT. AS I TESTIFIED, THERE WAS A DIFFERENCE BETWEEN THE TWO ADVIA'S USING THE SAME REAGENTS, BUT THAT DIFFERENCE WAS MARKEDLY EXACERBATED WHEN THE LDT WAS IMPLEMENTED.

314

MR. WADE: AND WE'LL GET TO THAT. BUT THE ASSAY DIDN'T FAIL, DID IT?

315

ADAM ROSENDORFF: NOT BASED ON QC. IN MY MIND THE ASSAY WAS FAILING BECAUSE WE HAD A SPATE OF HDL VALUES THAT DIDN'T SEEM BIOLOGICALLY PLAUSIBLE AS WE'VE LOOKED AT BEFORE.

316

MR. WADE: OKAY. LET'S KEEP GOING. AND THE GOVERNMENT DIDN'T SHOW YOU THIS DOCUMENT; RIGHT?

318

MR. WADE: AND LET'S GO TO 1559.

320

MR. WADE: YOU HAVE THAT? AND THAT'S ANOTHER EMAIL ON THE SAME SUBJECT; RIGHT?

322

MR. WADE: AND IT INVOLVES YOU AND OTHERS?

324

MR. WADE: MOVE THE ADMISSION OF 1559.

325

MR. BOSTIC: NO OBJECTION.

326

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

327

(GOVERNMENT'S EXHIBIT 1559 WAS RECEIVED IN EVIDENCE.)

328

MR. WADE: LET'S START ON THE SECOND PAGE WITH DR. PANDORI'S EMAIL.

329

MR. WADE: AND DO YOU SEE DOWN ON THE BOTTOM IT NOTES, ANYHOW, WE NEED TO DECIDE WHAT TO DO BECAUSE THESE ARE PILING UP. DO YOU SEE THAT?

331

MR. WADE: AND THAT MEANT THE TESTS WERE ON HOLD; RIGHT?

333

MR. WADE: AND THAT WAS APPROPRIATE; RIGHT?

335

MR. WADE: LET'S GO TO 1562, WHICH I THINK IS IN THE GOVERNMENT'S BINDER.

337

MR. WADE: AND THIS IS ANOTHER EMAIL WITH YOU AND OTHERS ON THE SAME TOPIC, IS THAT RIGHT, ON HDL?

338

ADAM ROSENDORFF: JUST GIVE ME A SECOND. IT APPEARS, YES, YES.

339

MR. WADE: MOVE THE ADMISSION OF 1562.

340

MR. BOSTIC: NO OBJECTION.

341

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

342

(GOVERNMENT'S EXHIBIT 1562 WAS RECEIVED IN EVIDENCE.)

343

MR. WADE: THANK YOU, YOUR HONOR.

344

MR. WADE: THIS WAS IN THE GOVERNMENT'S BINDER, BUT THEY DIDN'T SHOW YOU THIS ON DIRECT TESTIMONY; RIGHT?

346

MR. WADE: AND LET'S GO TO THE LAST -- THE BOTTOM EMAIL ON PAGE 5. IF WE CAN BLOW UP THE WHOLE BOTTOM HALF, PLEASE. DO YOU SEE THIS IS THE STUDY THAT YOU SUGGESTED, THE CONCLUSIONS FROM THAT STUDY YOU SUGGESTED; RIGHT?

347

ADAM ROSENDORFF: THESE ARE DANIEL'S CONCLUSIONS.

348

MR. WADE: RIGHT. YOU HAD SUGGESTED A STUDY AND YOU WERE WORKING COLLABORATIVELY AS A TEAM TO PERFORM THAT STUDY; CORRECT?

349

ADAM ROSENDORFF: WE HAVE TO LOOK AT THE DATA, SIR, TO SORT THROUGH THESE ISSUES.

350

MR. WADE: AND WE'LL LOOK AT SOME OF THAT DATA, SIR. BUT MY QUESTION TO YOU IS, DO YOU RECALL THAT YOU ASKED FOR INQUIRIES TO BE MADE ON THIS?

352

MR. WADE: AND INQUIRIES WERE MADE ALMOST IMMEDIATELY; RIGHT?

354

MR. WADE: INCLUDING BY DR. YOUNG?

356

MR. WADE: AND OTHERS?

358

MR. WADE: AND MR. BALWANI WAS WEIGHING IN; RIGHT?

360

MR. WADE: OKAY. AND IN THIS EMAIL HE REPORTS OUT THE RESULTS OF THAT STUDY. DO YOU SEE THAT? OR AT LEAST A STUDY. DO YOU SEE HE REPORTS THAT OUT?

361

ADAM ROSENDORFF: YEAH. I DO NOT AGREE WITH P-HDL ON FINGERSTICK AND VENOUS ARE VERY COMPARABLE. THE DATA WILL SHOW THAT THAT'S NOT IN FACT TRUE.

362

MR. WADE: OKAY. SO HE'S REPORTING HERE BASICALLY THAT THE FINGERSTICK AND VENOUS ARE VERY COMPARABLE. DO YOU SEE THAT?

363

ADAM ROSENDORFF: CORRECT, CORRECT.

364

MR. WADE: AND YOU DISAGREE WITH THAT?

366

MR. WADE: AND LET'S LOOK AT WHAT HE'S REPORTING FIRST AND THEN WE'LL GET TO YOU. OKAY? THE SECOND LINE THERE, HE REPORTS THAT THE FINGERSTICK COMPARES VERY WELL TO PREDICATE ON VENOUS; RIGHT?

368

MR. WADE: AND THAT MEANS THE GOLD STANDARD; RIGHT?

370

MR. WADE: AND SO THE FINGERSTICK COMPARES WELL TO THE GOLD STANDARD?

371

ADAM ROSENDORFF: YES, THAT'S WHAT HE'S SAYING.

372

MR. WADE: OKAY. AND THEN IT SAYS, WE DO NOT SEE A PROBLEM OF ABNORMALLY LOW HDL RESULTS. DO YOU SEE THAT?

374

MR. WADE: OKAY. LET'S GO TO YOUR RESPONSE. DO YOU SEE THIS STARTS ON THE THIRD PAGE?

376

MR. WADE: AND DO YOU SEE THAT EMAIL IS YOUR RESPONSE TO DR. YOUNG'S CONCLUSIONS; RIGHT?

378

MR. WADE: OKAY. LET'S GO TO THE SECOND PAGE.

379

ADAM ROSENDORFF: SO YOU'LL SEE THAT THE BIAS ON THE HDL FOR FINGERSTICK IS MUCH GREATER THAN THE BIAS FOR HDL USING VENOUS.

380

MR. WADE: MOVE TO STRIKE.

381

ADAM ROSENDORFF: THAT'S THE ISSUE WE'RE DISCUSSING, SIR.

382

JUDGE DAVILA: YES, BUT HE'LL ASK THE QUESTION.

384

JUDGE DAVILA: SO THAT'S STRICKEN. YOU CAN ASK YOUR QUESTION.

385

MR. WADE: THANK YOU.

386

MR. WADE: LET'S START ON THE SECOND PAGE. DO YOU SEE WHERE IT SAYS METHOD BIAS? I'M SORRY, IT'S THE BOTTOM OF PAGE 4. IT'S THE SECOND ITEM THERE. DO YOU SEE THAT? THERE'S A HEADING IN YOUR EMAIL THAT SAYS METHOD BIAS?

388

MR. WADE: OKAY. AND THAT SAYS, "THE P-PROTOCOL VALUES (FINGERSTICK AND VENOUS), FOR CHOLESTEROL AND HDL MATCH VERY WELL WITH THE PREDICATE VALUES." RIGHT?

390

MR. WADE: THOSE ARE YOUR WORDS, RIGHT, SIR?

392

MR. WADE: OKAY. AND THEN LET'S LOOK AT NUMBER 1, THE INSTRUMENT BIAS. AND BY THE WAY, WHEN YOU SAY THEY MATCH VERY WELL, THAT MEANS THE FINGERSTICK MATCHES WELL AGAINST THE GOLD STANDARD ASSAY; RIGHT?

394

MR. WADE: OKAY. LET'S -- AND AGAIN, THOSE ARE YOUR WORDS, RIGHT, SIR?

396

MR. WADE: OKAY. LET'S GO TO NUMBER 1, INSTRUMENT BIAS. DO YOU SEE THAT?

398

MR. WADE: AND IT SAYS, "IN GENERAL, INSTRUMENT BIAS IS GREATER THAN METHOD BIAS." DO YOU SEE THAT?

400

MR. WADE: AND THAT BIAS IS THE BIAS BETWEEN TWO COMMERCIAL MACHINES, TWO DIFFERENT ADVIA'S; RIGHT?

402

MR. WADE: AND SO THERE'S VARIABILITY BETWEEN TWO COMMERCIAL MACHINES; RIGHT?

404

MR. WADE: AND THAT HAPPENS SOMETIMES; RIGHT?

406

MR. WADE: OKAY. AND THOSE ARE THE CONCLUSIONS THAT WERE THE RESULT OF THIS STUDY; RIGHT?

408

MR. WADE: OKAY. AND IF YOU GO TO THE END OF THAT EMAIL, SAME EMAIL, NEXT PAGE. WE CAN BLOW UP THE LAST PARAGRAPH THERE. DO YOU SEE YOU THANK EVERYONE FOR LOOKING INTO THIS; RIGHT? DO YOU SEE THAT?

410

MR. WADE: AND YOU ATTACH THE DATA AND THE ANALYSIS AND YOU WELCOME COMMENTS; RIGHT?

412

MR. WADE: OKAY. AND THAT'S A GOOD TEAM COLLABORATIVE EFFORT; RIGHT?

414

MR. WADE: AND THE GOVERNMENT DIDN'T SHOW YOU THIS, DID THEY?

416

MR. WADE: OKAY. AND BASED ON THIS STUDY, DR. PANDORI RECOMMENDS THAT YOU RELEASE RESULTS; RIGHT?

417

ADAM ROSENDORFF: I'M SORRY, WHERE ARE YOU READING THAT?

418

MR. WADE: LET'S GO TO 1559.

419

ADAM ROSENDORFF: THAT'S NOT IN THE GOVERNMENT'S BINDER.

420

MR. WADE: IT WILL BE IN YOUR BLACK BINDER, VOLUME 1.

422

MR. WADE: OKAY. AND DO YOU SEE ON THE FIRST PAGE OF THIS EMAIL THAT DR. PANDORI SUGGESTS THAT THESE BE RESULTED OUT?

424

MR. WADE: AND THIS IS AFTER THAT STUDY?

426

MR. WADE: OKAY. AND SO IF I CAN GO BACK TO THE ELMO. IN FACT, DR. YOUNG AND MR. BALWANI JUMPED ON THIS PROBLEM; RIGHT?

428

MR. WADE: AND THE QC SHOULD HAVE CAUGHT THE ISSUE IF IT WAS DONE AS YOU HAD DIRECTED; RIGHT?

429

ADAM ROSENDORFF: NO. THE WESTGARD WAS NOT PART OF OUR SOP.

430

MR. WADE: SIR, THAT WAS THE POLICY IN THE EMAIL THAT YOU SAID SHOULD HAVE HAPPENED AND DIDN'T; RIGHT?

431

ADAM ROSENDORFF: I NOTED IN THE EMAIL THAT IF WE WERE TO APPLY THAT WESTGARD RULE, IT WOULD HAVE BEEN A FAILURE.

432

MR. WADE: OKAY. AND THIS WAS NOT A THERANOS ASSAY PROBLEM; RIGHT? THIS WAS AN ASSAY VARIABILITY PROBLEM?

433

ADAM ROSENDORFF: NO, SIR, I DISAGREE.

435

ADAM ROSENDORFF: IF YOU -- I CAN CLARIFY THAT COMMENT IF NEEDED.

436

MR. WADE: SIR, I'M LOOKING AT YOUR WORDS IN YOUR EMAIL WHERE YOU SAY THAT THE THERANOS ASSAY AND THE GOLD STANDARD COMPARED WELL; CORRECT?

437

ADAM ROSENDORFF: RIGHT. I'M LOOKING AT THE DATA NOW --

438

MR. WADE: THAT'S THE QUESTION THAT I HAVE PENDING TO YOU.

439

ADAM ROSENDORFF: YES, THAT WAS MY STATEMENT THEN.

440

MR. WADE: AND DO YOU STAND BY THOSE WORDS?

441

ADAM ROSENDORFF: NO. LOOKING AT THE DATA NOW.

442

MR. WADE: I'M NOT INTERESTING IN YOUR ANALYSIS NOW. I'M INTERESTED IN WHAT YOU SAID AT THE TIME, SIR.

443

ADAM ROSENDORFF: AT THE TIME, YES.

444

MR. WADE: OKAY. I'D LIKE TO SWITCH TOPICS TO DISCUSS THE ICE'S. DO YOU RECALL TESTIMONY -- ISE'S, I'M SORRY, NOT ICE.

446

MR. WADE: DO YOU RECALL THE TESTIMONY THAT YOU GAVE RELATING TO THAT TOPIC?

448

MR. WADE: AND DO YOU RECALL INITIALLY THAT THE GOVERNMENT SHOWED YOU A DOCUMENT THAT RELATED TO SOME QUESTIONS THAT CAME UP IN LATE AUGUST OF 2013 RELATING TO ISE'S?

449

ADAM ROSENDORFF: I DON'T RECALL THE DATE, BUT THEY WERE ASKING ME ABOUT ISE'S, YES.

450

MR. WADE: YEAH. AND IT WAS LATE AUGUST THEN AND THE IDEA WAS THAT IT WAS RIGHT ON THE EVE OF THE LAUNCH. DO YOU RECALL THAT?

452

MR. WADE: WHICH WE'VE ESTABLISHED WAS THE SOFT LAUNCH; RIGHT?

453

ADAM ROSENDORFF: IT WAS PATIENT TESTING.

454

MR. WADE: IT WAS THE SOFT LAUNCH FOR FRIENDS AND FAMILY; RIGHT?

455

ADAM ROSENDORFF: THOSE ARE PATIENTS.

456

MR. WADE: I UNDERSTAND. BUT THAT'S NOT MY QUESTION. MY QUESTION WAS, THAT WAS THE SOFT LAUNCH. DO YOU RECALL THAT?

458

MR. WADE: AND DO YOU RECALL THAT SPREADSHEET OF ALL OF THE TESTS THAT WE LOOKED AT?

460

MR. WADE: AND THERE WERE SOME DAYS THAT THERE WERE NO TESTS. DO YOU RECALL THAT?

461

ADAM ROSENDORFF: I DON'T RECALL.

462

MR. WADE: OKAY. DO YOU RECALL THE TESTIMONY ABOUT THE PUBLIC LAUNCH?

464

MR. WADE: AND THAT WAS TWO MONTHS LATER; RIGHT?

466

MR. WADE: OKAY. AND IF THERE ARE QUESTIONS THAT ARE RAISED IN AUGUST AND THEN YOU SIGN A VALIDATION REPORT AT A LATER DATE, IS IT A FAIR CONCLUSION THAT WHATEVER THAT ISSUE WAS OR QUESTION WAS, YOU WOULD HAVE ADDRESSED IT BEFORE YOU SIGNED THE VALIDATION REPORT; RIGHT?

467

ADAM ROSENDORFF: I SIGNED THE VALIDATION REPORT ON THE BASIS OF THE DATA THAT IS IN THE VALIDATION.

468

MR. WADE: RIGHT. WITHOUT ANY CONCERNS AT THAT POINT AS TO WHETHER IT'S APPROPRIATE FOR PATIENT USE?

469

ADAM ROSENDORFF: NO. OF COURSE I'M CONCERNED ABOUT APPROPRIATENESS FOR PATIENT USE.

470

MR. WADE: MY POINT IS, AT THE POINT -- I BELIEVE YOU TESTIFIED ABOUT THIS MANY TIMES WITH RESPECT TO MANY DOCUMENTS. AT THE POINT THAT YOU'RE PUTTING YOUR SIGNATURE ON THAT DOCUMENT, YOU BELIEVED THAT THAT ASSAY IS APPROPRIATE FOR PATIENT USE?

472

MR. WADE: OKAY. AND LET'S JUST LOOK AT -- LET'S BRING UP, IT'S IN EVIDENCE, 9099. DO YOU SEE THAT?

474

MR. WADE: AND THIS IS A VALIDATION REPORT RELATING TO ONE OF THE ISE ASSAYS. DO YOU SEE THAT?

476

MR. WADE: AND THIS IS ACTUALLY THE FIRST REVISION. DO YOU SEE THAT?

478

MR. WADE: AND IT SAYS THE DATE, THE INITIAL DATE WAS 9-26-2013; RIGHT?

480

MR. WADE: AND THEN YOU SIGNED THIS UPDATED DOCUMENT IN MARCH OF 2014; CORRECT?

482

MR. WADE: OKAY. AND LET'S GO TO 9352, WHICH IS IN EVIDENCE. THIS IS FOR THE SODIUM ASSAY; CORRECT?

484

MR. WADE: OKAY. AND SAME THING, IT WAS INITIALLY EFFECTIVE SEPTEMBER 26TH, 2013; RIGHT?

486

MR. WADE: AND THAT'S AFTER AUGUST OF 2013; CORRECT?

487

ADAM ROSENDORFF: YES, SIR, SEPTEMBER IS AFTER AUGUST.

488

MR. WADE: THANK YOU, DOCTOR. AND YOU SIGNED IT AGAIN ON MARCH 24TH, 2014; RIGHT?

490

MR. WADE: THAT'S AN UPDATED VERSION?

492

MR. WADE: OKAY. AND LET'S GO TO ONE MORE. THIS IS ONE OF THE ISE ASSAYS; CORRECT?

494

MR. WADE: AND LET'S GO TO 9315. THIS IS FOR THE POTASSIUM ASSAY; CORRECT?

496

MR. WADE: AND THAT'S ONE OF THE ICE ASSAYS?

498

MR. WADE: SAME THING HERE, 9-26-2013?

500

MR. WADE: AND YOU SIGNED IT AGAIN IN MARCH OF 2014; CORRECT?

502

MR. WADE: AND YOU -- THERE WAS SOME ONGOING WORK THAT WAS DONE ON THE ISE ASSAYS; CORRECT?

503

ADAM ROSENDORFF: YES, THERE WERE TERRIBLE PROBLEMS WITH THE ISE'S AND CONTINUOUS WORK TO TRY TO TROUBLESHOOT.

504

MR. WADE: YOU NEVER PULLED THE ASSAYS, CORRECT, SIR?

505

ADAM ROSENDORFF: NO. WELL, I ORDERED POTASSIUM THAT WAS ABOVE THE -- THE POTASSIUM RESULTS THAT WERE OUT OF RANGE WERE NOT REPORTED, AND SO THE RESULTS THAT WERE OUT OF RANGE WERE NOT REPORTED.

506

MR. WADE: RIGHT. BUT I WANT TO MAKE SURE WE HAVE YOUR TESTIMONY CLEAR, BECAUSE IT'S YOUR JOB TO DETERMINE WHETHER AN ASSAY IS SAFE FOR PATIENT USE; RIGHT?

508

MR. WADE: AND YOU NEVER REMOVED THESE ASSAYS FROM THE LABORATORY; CORRECT?

510

MR. WADE: AND THERE WAS ONGOING -- MY INITIAL QUESTION WAS THERE WAS ONGOING RESEARCH AND DISCUSSIONS THAT WAS HAPPENING WITH RESPECT TO THESE ASSAYS; CORRECT?

512

MR. WADE: AND YOU TESTIFIED ABOUT SOME DISAGREEMENTS THAT YOU HAD ACTUALLY WITH DR. YOUNG ABOUT THESE ASSAYS; CORRECT?

513

ADAM ROSENDORFF: I DON'T RECALL.

514

MR. WADE: OKAY. LET'S LOOK AT 12607 WHICH SHOULD BE -- DO YOU SEE THAT IN YOUR SECOND BINDER?

516

MR. WADE: AND THIS IS SOME WORK THAT WAS DONE IN CONNECTION WITH --

518

MR. WADE: -- THOSE ASSAYS? LET'S TAKE A LOOK AT THAT. I'M SORRY. I MOVE TO ADMIT EXHIBIT 12607.

519

MR. BOSTIC: OBJECTION. HEARSAY.

520

(PAUSE IN PROCEEDINGS.)

521

JUDGE DAVILA: THE ENTIRETY OF THE DOCUMENT YOU'RE ASKING?

522

MR. WADE: I WAS ASKING, YOUR HONOR. I CAN ADMIT FOR PRESENT PURPOSES EVERYTHING FROM THE MIDDLE OF THE FIRST PAGE BELOW FOR A LIMITED PURPOSE IF THAT'S EASIER.

523

JUDGE DAVILA: STRIKING THE TOP?

524

MR. WADE: YEAH, AND I WOULD NOT PUBLISH THAT. I MAY REFRESH THE WITNESS'S RECOLLECTION WITH THOSE PORTIONS OF THE DOCUMENT.

525

JUDGE DAVILA: I'LL SUSTAIN THE OBJECTION FOR NOW. WHY DON'T YOU ASK YOUR QUESTIONS?

527

MR. WADE: DO YOU RECALL BEING CALLED BY MS. HOLMES FROM HER OFFICE IN APRIL OF 2014 TO ENGAGE IN A DISCUSSION WITH HER AND DR. YOUNG ABOUT THE POTASSIUM ASSAYS?

529

MR. WADE: TAKE A LOOK AT THE BOTTOM OF THE FIRST PAGE OF 12607.

531

MR. WADE: AND THEN ON TO THE SECOND PAGE.

533

MR. WADE: DOES THAT REFRESH YOUR RECOLLECTION THAT YOU WERE CALLED BY MS. HOLMES TO HAVE A DISCUSSION WITH HER AND MR. YOUNG -- DR. YOUNG WITH RESPECT TO THE POTASSIUM ASSAYS?

534

ADAM ROSENDORFF: I DON'T HAVE AN INDEPENDENT RECOLLECTION OF THAT OTHER THAN READING IT TODAY HERE IN THE DOCUMENTS.

535

MR. WADE: OKAY. DO YOU RECALL THAT -- A DISCUSSION THAT YOU ENGAGED IN WITH DR. YOUNG AND MS. HOLMES ABOUT THE POTASSIUM ASSAY AND YOU FELT AS THOUGH MS. HOLMES WAS SIDING WITH DR. YOUNG?

536

ADAM ROSENDORFF: I DO NOT RECALL.

537

MR. WADE: OKAY. DO YOU RECALL WRITING AN EMAIL TO MS. HOLMES IN APRIL OF 2014 DISCUSSING YOUR VIEWS WITH RESPECT TO THESE MATTERS?

538

ADAM ROSENDORFF: YES, I'M READING THAT NOW. I DON'T INDEPENDENTLY RECALL. THAT WAS SEVEN YEARS AGO. I'M SORRY.

539

MR. WADE: I MOVE TO ADMIT EVERYTHING BELOW THAT, YOUR HONOR, FOR LIMITED PURPOSE OF MY CLIENT'S STATE OF MIND.

540

JUDGE DAVILA: EVERYTHING BELOW? EVERYTHING BELOW WHAT?

541

MR. WADE: EVERYTHING FROM THE MARCH 18TH, 2014 EMAIL BELOW.

542

MR. BOSTIC: DO YOU MEAN APRIL, COUNSEL?

543

MR. WADE: I'M SORRY, APRIL. THANK YOU.

544

MR. BOSTIC: WHICH EMAIL?

545

MR. WADE: THE 10:39 A.M. AND THEN BELOW.

546

MR. BOSTIC: YOUR HONOR, NO OBJECTION TO THAT.

547

(PAUSE IN PROCEEDINGS.)

548

JUDGE DAVILA: ALL RIGHT. THAT PORTION WILL BE ADMITTED, AND IT MAY BE PUBLISHED. CAN YOU REDACT THE OTHER PORTIONS?

549

(DEFENDANT'S EXHIBIT 12607 WAS RECEIVED IN EVIDENCE.)

550

MR. WADE: WE'LL REDACT EVERYTHING ABOVE. LET'S GO TO THE SECOND PAGE.

551

MR. WADE: THIS IS 12607.

553

MR. WADE: AND DO YOU SEE THE EMAIL THERE WHERE YOU'RE SAYING THAT YOU'LL CALL MS. HOLMES AND TOUCH BASE TOMORROW MORNING?

555

MR. WADE: DO YOU SEE THAT?

557

MR. WADE: AND SHE ASKED YOU TO DROP IN IF YOU'RE AROUND?

559

MR. WADE: BUT IT WAS KIND OF LATE; RIGHT?

561

MR. WADE: LET'S GO UP TO THE NEXT PAGE. DO YOU SEE SHE ASKS YOU TO CALL IN, AND IT SAYS, WE'RE ON THE LINE WITH DANIEL?

563

MR. WADE: DO YOU SEE THAT?

565

MR. WADE: AND, AND DO YOU SEE UP ABOVE THERE'S AN EMAIL WHERE YOU'RE WEIGHING IN ON THE POTASSIUM ASSAY? DO YOU SEE THAT?

567

MR. WADE: AND DOES THAT REFRESH YOUR RECOLLECTION THAT YOU AND DR. YOUNG WERE WEIGHING IN WITH MS. HOLMES ABOUT THE POTASSIUM ASSAY IN THIS PERIOD?

568

ADAM ROSENDORFF: I DON'T HAVE AN INDEPENDENT RECOLLECTION OF IT.

569

MR. WADE: DO YOU RECALL HAVING DISAGREEMENTS WITH MR. YOUNG ABOUT THESE MATTERS?

570

ADAM ROSENDORFF: I RECALL ME REPEATEDLY RAISING PROBLEMS WITH POTASSIUM, DR. YOUNG BEING ASKED TO FIX THOSE PROBLEMS, HIM ASSERTING THE PROBLEMS HAD BEEN FIXED, BUT THEN THE PROBLEMS RECURRING.

571

MR. WADE: RIGHT. AND THERE WERE TIMES WHERE YOU FOUND SOLUTIONS TO THE PROBLEMS AS WELL; RIGHT?

572

ADAM ROSENDORFF: I WASN'T REALLY IN THE R&D SIDE INVOLVED IN THE PARTICULAR ASPECTS OF THE ASSAY. SO I WAS IN A POSITION TO POINT OUT PROBLEMS WITH THE ASSAY AND SUGGEST ROOT CAUSES, RIGHT, BUT I WAS FAIRLY LIMITED IN TERMS OF TROUBLESHOOTING. THAT REALLY WASN'T MY AREA OF EXPERTISE.

573

MR. WADE: THAT'S PART OF THE REASON WHY DR. YOUNG WAS ON A LOT OF THESE EMAILS; RIGHT?

575

MR. WADE: THAT'S BECAUSE HE WAS MORE INVOLVED IN SOME OF THE RESEARCH AND DEVELOPMENT ON THE ASSAYS?

576

ADAM ROSENDORFF: MORE OF THE TECHNICAL HARDWARE ASPECTS, YES.

577

MR. WADE: AND HE COULD DRAW UPON OTHER RESOURCES TO HELP PROVIDE INSIGHTS; RIGHT?

579

MR. WADE: AND WHEN YOU WOULD RAISE ISSUES OR CONCERNS, HE WAS GOING TO WORK TO TRY TO FIGURE OUT A SOLUTION; RIGHT?

581

MR. WADE: AND MANY TIMES HE CAME UP WITH WHAT APPEARED TO BE SOLUTIONS; RIGHT?

583

MR. WADE: AND THAT DIDN'T ALWAYS TAKE HOLD; CORRECT?

585

MR. WADE: OKAY. AND LET'S LOOK -- BUT I THINK THERE ARE SOMETIMES WHEN YOU CAME UP WITH SOLUTIONS. DO YOU RECALL THAT -- YOU PROPOSING THAT YOU RUN THE THERANOS ASSAYS NEAT?

586

ADAM ROSENDORFF: YES. DANIEL DIDN'T FEEL THAT WAS A GOOD SOLUTION. I BELIEVE HE SAID NOT A GOOD SOLUTION CLEARLY.

587

MR. WADE: OKAY. LET'S LOOK AT -- LET'S LOOK AT 1717, WHICH IS IN EVIDENCE, I BELIEVE. I THINK THIS IS THE DOCUMENT THAT YOU WERE TALKING ABOUT; RIGHT?

589

MR. WADE: AND ON YOUR DIRECT TESTIMONY, YOU WERE ASKED ABOUT DR. YOUNG'S RESPONSE TO YOUR SUGGESTION ON RUNNING THESE NEAT. DO YOU RECALL THAT?

591

MR. WADE: I BELIEVE YOU JUST TESTIFIED A MINUTE AGO THAT DR. YOUNG DIDN'T LIKE THAT SOLUTION?

592

ADAM ROSENDORFF: WELL, HE SAID -- IN THE EMAIL, HE SAID, NOT A VERY GOOD ONE CLEARLY. HE DIDN'T LIKE THE SOLUTION.

593

MR. WADE: HE DIDN'T LIKE THE SOLUTION?

595

MR. WADE: BUT YOU ACTUALLY ADOPTED THE SOLUTION; RIGHT?

596

ADAM ROSENDORFF: I DO NOT RECALL.

597

MR. WADE: WELL, LET'S LOOK.

598

ADAM ROSENDORFF: I MEAN THE -- ANYWAY.

599

MR. WADE: LET'S TAKE A LOOK AT EXHIBIT 13891, WHICH SHOULD BE IN YOUR BLACK BINDER. PROBABLY SECOND VOLUME, DOCTOR.

600

ADAM ROSENDORFF: I'M SORRY, I DON'T SEE IT.

601

MR. WADE: 13891.

602

ADAM ROSENDORFF: CORRECT. OH, I HAVE IT NOW.

603

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

605

MR. WADE: AND 13891 ARE MINUTES FROM YOUR LAB DIRECTOR MEETING MAY 20TH, 2014. DO YOU SEE THAT?

606

ADAM ROSENDORFF: I'M SORRY. COULD SOMEBODY COME AND HELP ME WITH THE BINDER. IT'S JUST BECOME -- IT'S JUST OPENED UP AND PAGES HAVE --

607

MR. WADE: SURE. WITH THE COURT'S INDULGENCE FOR A MOMENT?

608

ADAM ROSENDORFF: CAN WE TAKE A SMALL RECESS FOR THAT?

609

JUDGE DAVILA: WELL, WHY DON'T YOU SEE IF YOU CAN SOLVE THE PROBLEM, MR. WADE.

610

BY MR. WADE:

611

MR. WADE: IF YOU COULD TAKE OUT 13891, IF IT'S OPEN, AND THEN I'LL HAVE YOU HOLD ON TO THAT DOCUMENT AND I'LL BRING THE BINDER BACK AND WE'LL WORK ON IT WHILE WE'RE TALKING ABOUT 13891. I'LL TELL YOU WHAT? WHY DON'T YOU GIVE IT TO ME, I'LL TAKE IT OUT AND HAND IT BACK UP. MAY I APPROACH, YOUR HONOR?

613

MR. WADE: (HANDING.)

615

BY MR. WADE:

616

MR. WADE: DO YOU HAVE 13891 IN FRONT OF YOU, DOCTOR?

617

ADAM ROSENDORFF: THE -- YES.

618

MR. WADE: AND THESE ARE THE LABORATORY DIRECTOR MEETING MINUTES FOR MAY 20TH, 2014?

620

MR. WADE: MOVE THE ADMISSION OF 13891.

621

MR. BOSTIC: NO OBJECTION.

622

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

623

(DEFENDANT'S EXHIBIT 13891 WAS RECEIVED IN EVIDENCE.)

624

MR. WADE: AND IF WE CAN GO TO THE SECOND PAGE.

625

MR. WADE: DO YOU SEE ITEM 7?

627

MR. WADE: AND THAT'S THE ISE'S. DO YOU SEE THAT?

629

MR. WADE: AND IT SAYS, "WITH NEAT TESTING, SODIUM AND CHLORIDE HAS SETTLED DOWN." DO YOU SEE THAT?

631

MR. WADE: AND IT SOUNDS LIKE YOUR SUGGESTION WAS FOLLOWED, RIGHT, DOCTOR?

632

ADAM ROSENDORFF: IT LOOKS THAT WAY, YES.

633

MR. WADE: AND EVEN THOUGH IT MIGHT NOT HAVE BEEN A PERMANENT SOLUTION, IT WAS A SOLUTION THAT WAS FOLLOWED ON A TEMPORARY BASIS?

634

ADAM ROSENDORFF: YEAH, THE COMPANY DIDN'T REALLY LIKE THAT SOLUTION.

635

MR. WADE: AND THEY KEPT WORKING ON OTHER SOLUTIONS; RIGHT?

636

ADAM ROSENDORFF: I GUESS SO.

637

MR. WADE: WELL, LET'S LOOK AT -- MAY I APPROACH AGAIN, YOUR HONOR?

638

(HANDING.) DR. ROSENDORFF, TURN IN YOUR BIND TO 13893. DO YOU SEE THAT?

640

MR. WADE: AND THIS IS AN EMAIL RELATING TO A SOLUTION THAT DR. YOUNG HAD IN CONNECTION WITH THE ISE --

642

MR. WADE: -- ISSUE?

644

MR. WADE: AND THIS IS THE ITEM THAT WE'VE JUST BEEN TALKING ABOUT; RIGHT?

646

MR. WADE: MOVE THE ADMISSION OF 13893.

647

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

648

(DEFENDANT'S EXHIBIT 13893 WAS RECEIVED IN EVIDENCE.)

649

BY MR. WADE:

650

MR. WADE: LET'S GO TO THE SECOND PAGE. DO YOU SEE THERE IT SAYS -- DR. YOUNG SAYS YOU'RE NOT ON THIS EMAIL, BUT IT'S FORWARDED TO YOU LATER. DO YOU SEE THAT?

651

ADAM ROSENDORFF: I SEE THAT I'M NOT ON IT. I DON'T SEE WHERE IT WAS FORWARDED TO ME LATER.

652

MR. WADE: WELL, YOU SEE YOU'RE ON THE CHAIN LATER UP THE CHAIN. DO YOU SEE THAT?

656

MR. WADE: OKAY. LET'S -- DR. YOUNG SAYS IN THIS EMAIL TO MS. HOLMES AND MR. BALWANI, "I WANTED TO UPDATE YOU ON THE ISE STUDIES IN PREPARATION FOR SWITCHING BACK TO THE DILUTED ISE PROTOCOLS ON TUESDAY." DO YOU SEE THAT?

658

MR. WADE: AND SUGGESTING THAT BEFORE THEY WERE BEING RUN NEAT; CORRECT?

660

MR. WADE: AND THEN HE SAYS, "WITH OUR NEW APPROACH, WE HAVE NOW SHOWN THAT WE CAN PROCESS AND RUN ISE'S WITH DILUTED VENOUS SAMPLES WITH GREAT ACCURACY AND PRECISION." DO YOU SEE THAT?

662

MR. WADE: AND DO YOU SEE HE NOTES THAT OVER 10 DAYS, 48 SUBJECTS WERE RUN ON THAT PROJECT THAT HE WAS WORKING ON?

664

MR. WADE: OKAY. AND HE SAYS NEVERTHELESS -- IF WE GO DOWN TO THE NEXT PARAGRAPH --

665

ADAM ROSENDORFF: SO IN PRACTICE VENOUS BLOOD WAS NEVER DILUTED ON THE THERANOS METHODS.

666

MR. WADE: MOVE TO STRIKE, YOUR HONOR.

667

JUDGE DAVILA: OVERRULED. OVERRULED. YOU CAN ASK ANOTHER QUESTION.

668

BY MR. WADE:

669

MR. WADE: DO YOU SEE THE NEXT HEADING THERE WHERE IT SAYS ADDITIONAL ISSUES THAT HE PLANS TO ADDRESS WITH THE TEAM? HE MENTIONS THAT?

671

MR. WADE: AND SO HE'S GOING TO CONTINUE TO WORK ON IT?

673

MR. WADE: BUT HE WAS ANNOUNCING THIS UPDATE. DO YOU SEE THAT?

675

MR. WADE: OKAY. LET'S GO TO THE NEXT PAGE. DO YOU SEE AT THE BOTTOM MR. BALWANI WRITES HOW THIS IS GREAT PROGRESS AND A BIG COMPETITIVE ADVANTAGE?

677

MR. WADE: AND THEN HE NOTES, "WE NEED TO KEEP THIS PROJECT, THE CODE, CALIBRATION, AND EVERYTHING WE LEARNED HERE AS THERANOS TRADE SECRET." DO YOU SEE THAT?

679

MR. WADE: BECAUSE THIS WAS PROPRIETARY INFORMATION; RIGHT?

680

ADAM ROSENDORFF: I CAN'T COMMENT ON WHAT THE STATE OF THE ART WAS IN TERMS OF DR. YOUNG'S FIX AND WHAT OTHER FOLKS WERE DOING, WHETHER THAT WOULD QUALIFY AS PROPRIETARY, YOU KNOW -- GO AHEAD. I'M SORRY.

681

MR. WADE: WELL, YOU RECOGNIZE THAT THE COMPANY CONSIDERED IT PROPRIETARY INFORMATION HERE?

682

ADAM ROSENDORFF: MR. BALWANI DID, YES.

683

MR. WADE: OKAY. AND HE SAYS, "EVERYONE WHO IS WORKING ON THIS NEEDS TO UNDERSTAND THIS." DO YOU SEE THAT?

685

MR. WADE: AND PART OF THE REASON THAT I THINK YOU'RE COPIED IN IT SAYS, "BESIDES ADAM, NO ONE IN CLIA NEEDS TO KNOW OUR SECRET SAUCE." DO YOU SEE THAT?

687

MR. WADE: AND IF ADAM THINKS ANYONE ELSE NEEDS TO KNOW THIS, THEN WE NEED TO GET THEM UNDER SAME AGREEMENT TO KEEP THIS CONFIDENTIAL; RIGHT?

689

MR. WADE: BECAUSE HE SAYS THEY'RE TRADE SECRETS; RIGHT?

691

MR. WADE: AND THEN DR. YOUNG THEN SAYS THAT HE'LL ADDRESS THIS WITH MONA RAMAMURTHY. DO YOU SEE THAT?

693

MR. WADE: AND THEN YOU WEIGH IN AND YOU CONGRATULATE DANIEL ON THE WORK THAT HE HAD DONE; RIGHT?

695

MR. WADE: BECAUSE THAT SEEMED LIKE A SUCCESS AT THE TIME; RIGHT?

696

ADAM ROSENDORFF: IT SEEMED LIKE IT.

697

MR. WADE: AND THEN OTHERS CONGRATULATED DANIEL AS WELL; RIGHT?

699

MR. WADE: OKAY. NOW, LET ME BRING UP 1953, WHICH IS IN EVIDENCE, AND IT'S IN YOUR BINDER IF YOU WOULD LIKE TO LOOK AT IT.

701

MR. WADE: OKAY. AND 1953 WAS AN EMAIL BETWEEN -- THAT YOU'RE NOT ON; RIGHT?

703

MR. WADE: AND THAT WAS AN EMAIL BETWEEN CHRISTIAN HOLMES AND ELIZABETH HOLMES; RIGHT?

705

MR. WADE: AND HE WAS DISCUSSING ISSUES WITH RESPECT TO EXPERIENCES THAT PEOPLE WERE HAVING WITH THE ISE ASSAYS; CORRECT?

707

MR. WADE: AND YOU WERE ASKED QUESTIONS ABOUT THIS; RIGHT?

709

MR. WADE: BUT THE GOVERNMENT DIDN'T SHOW YOU ANY FOLLOWUP ON THIS; RIGHT?

710

ADAM ROSENDORFF: I DO NOT RECALL.

711

MR. WADE: AND YOU DON'T KNOW WHAT ELSE MS. HOLMES WAS DEALING WITH ON THESE ISSUES; RIGHT? BECAUSE YOU'RE NOT ON THE EMAIL; RIGHT?

712

ADAM ROSENDORFF: RIGHT, RIGHT.

713

MR. WADE: WELL, LET'S GO TO 12764. DO YOU SEE THAT'S AN EMAIL OF THE SAME DATE?

714

ADAM ROSENDORFF: I'M SORRY, CAN YOU PLEASE GIVE ME A MINUTE?

715

MR. WADE: YEAH, SURE.

716

ADAM ROSENDORFF: 12764, AND IT'S STILL IN THE WHITE BINDER?

717

MR. WADE: NO. MY APOLOGIES. WE'RE PROBABLY BACK TO THE BLACK BINDER NOW.

719

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

721

MR. WADE: AND THIS IS AN EMAIL UP AT THE TOP ON THAT SAME DATE, SEPTEMBER 23RD, 2014?

723

MR. WADE: DO YOU SEE THAT? AND IT RELATES TO THAT SAME TOPIC THAT -- MANY OF THE SAME ASSAYS THAT CHRISTIAN HOLMES WAS REFERRING TO; CORRECT?

724

ADAM ROSENDORFF: THIS ONE LOOKS LIKE IT'S ABOUT C02, AND CHRISTIAN WAS TALKING ABOUT SODIUM, POTASSIUM, AND CHLORIDE, I BELIEVE.

725

MR. WADE: AND DO YOU SEE THE REFERENCE TO POTASSIUM THERE AS WELL?

726

ADAM ROSENDORFF: I'M SORRY, WHICH EMAIL ARE YOU REFERENCING?

727

MR. WADE: THE THIRD ONE DOWN.

729

MR. WADE: OKAY. YOUR HONOR, I WOULD MOVE THE ADMISSION OF 12764.

730

MR. BOSTIC: NO OBJECTION.

731

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

732

(DEFENDANT'S EXHIBIT 12764 WAS RECEIVED IN EVIDENCE.)

733

BY MR. WADE:

734

MR. WADE: AND THIS IS AN EMAIL WHERE MS. HOLMES IS GETTING SOME UPDATES ON THESE ASSAYS ON THE SAME DATE, ON SEPTEMBER 23RD, 2014; RIGHT?

736

MR. WADE: OKAY. I DON'T HAVE ANY OTHER QUESTIONS ABOUT THIS. LET ME BRING UP 2228, WHICH SHOULD BE IN THE GOVERNMENT'S BINDER.

738

MR. WADE: YOU HAVE THAT? LET'S GO TO THE SECOND PAGE. DO YOU RECALL THIS EMAIL WHERE YOU FORWARDED ON NOVEMBER 21ST AN EMAIL ABOUT THE ISE'S AND YOU SAID -- AND THE VOIDING OF CERTAIN RESULTS. DO YOU SEE THAT?

740

MR. WADE: AND YOU'RE ASKING THEM, ARE YOU COMFORTABLE WITH THAT; RIGHT?

742

MR. WADE: AND NOW IN THE EMAIL UP THE CHAIN, MR. BALWANI SUGGESTS THAT MAYBE YOU JUMPED THE GUN; RIGHT? DO YOU SEE THAT?

744

MR. WADE: BUT MORE FUNDAMENTALLY, YOU SAID THAT YOU WEREN'T COMFORTABLE WITH TAKING THIS APPROACH; RIGHT? WITH VOIDING THE RESULT? THAT'S WHAT YOU SAID IN THE PRIOR EMAIL?

745

ADAM ROSENDORFF: IT WAS THE BEST I COULD DO TO PROTECT PATIENTS.

746

MR. WADE: RIGHT, RIGHT. BUT YOU'RE ASKING, ARE THEY BOTH COMFORTABLE WITH THIS; RIGHT?

748

MR. WADE: THE VOIDING OF THE RESULTS WAS ACTUALLY SOMETHING THAT YOU AND YOUR GROUP CAME UP WITH --

750

MR. WADE: -- A COUPLE WEEKS EARLIER; RIGHT?

751

ADAM ROSENDORFF: A LONG TIME BEFORE THIS EMAIL, YES.

752

MR. WADE: RIGHT. AND, IN FACT, MR. BALWANI AND MS. HOLMES DIDN'T KNOW ABOUT IT; RIGHT? YOU MADE THAT DECISION INDEPENDENT OF THEM?

753

ADAM ROSENDORFF: THEY KNEW ABOUT IT.

754

MR. WADE: OKAY. LET'S GO TO 7490. DO YOU HAVE THAT DOCUMENT IN FRONT OF YOU?

756

MR. WADE: AND THIS IS AN EMAIL INVOLVING YOU, MR. BALWANI AND MS. HOLMES IN LATE OCTOBER 2014?

758

MR. WADE: ON THE SAME TOPIC, THE CRITICAL ISE'S?

760

MR. WADE: MOVE THE ADMISSION OF 7490.

761

MR. BOSTIC: NO OBJECTION.

762

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

763

(DEFENDANT'S EXHIBIT 7490 WAS RECEIVED IN EVIDENCE.)

764

MR. WADE: LET'S BLOW UP THE TOP HALF OF THAT EMAIL.

765

MR. WADE: ACTUALLY, LET'S START -- DO YOU SEE THERE IT SAYS -- LET'S START DOWN THE CHAIN. I'M SORRY. LET'S GO TO THE LAST EMAIL ON THIS PAGE. YOU SAY HERE, "I WANTED TO BRING THIS IMPORTANT ISSUE TO YOUR ATTENTION. RIGHT NOW, AFTER MUCH COOPERATIVE DISCUSSION BETWEEN CLIA AND R&D AND THOUGHT, IF THE CTN --" YOU TALK ABOUT VOIDING CRITICAL RESULTS; RIGHT?

766

ADAM ROSENDORFF: THAT'S THE SODIUM THAT I'M REFERRING TO --

767

MR. WADE: RIGHT.

768

ADAM ROSENDORFF: -- IN THAT EMAIL, YES.

769

MR. WADE: AND THE RESPONSE FROM MR. BALWANI IS, LET'S TOUCH BASE, WHEN DO WE START THIS POLICY? RIGHT?

770

ADAM ROSENDORFF: SO THE VOIDING OF THE POTASSIUM RESULTS OUT OF RANGE HAD BEGUN MUCH, MUCH EARLIER THAN THAT.

771

MR. WADE: RIGHT. YOU SEE HE DIDN'T KNOW ABOUT THIS; RIGHT?

772

ADAM ROSENDORFF: THAT'S WHAT HE'S ASSERTING.

773

MR. WADE: OKAY. LET'S LOOK AT YOUR EMAIL UP THE CHAIN. YOU EXPLAIN, "WE HAD A MEETING WITH TINA, NISHIT, AND CLIA LEADERSHIP ABOUT 6 WEEKS AGO TO COME UP WITH A CONSISTENT PRACTICE." DO YOU SEE THAT?

775

MR. WADE: AND THAT WAS YOUR DECISION; RIGHT?

777

MR. WADE: AND YOU MADE IT IN CONJUNCTION WITH OTHERS?

779

MR. WADE: AND IT LOOKS LIKE -- AND MR. BALWANI SAYS HE DIDN'T EVEN KNOW ABOUT IT; RIGHT?

780

ADAM ROSENDORFF: THAT'S WHAT HE'S SAYING.

781

MR. WADE: SO WHEN YOU'RE ASKING THEM IF THEY'RE COMFORTABLE WITH THAT PRACTICE IN NOVEMBER TWO WEEKS LATER, YOU'RE TALKING ABOUT A PRACTICE THAT YOU IMPLEMENTED; CORRECT?

783

MR. WADE: AND A PRACTICE THAT THEY DIDN'T EVEN KNOW ABOUT FOR SIX WEEKS UNTIL AFTER YOU WERE DOING IT; RIGHT?

784

ADAM ROSENDORFF: WELL, THEY KNEW ABOUT IT IN NOVEMBER.

785

MR. WADE: WELL, THEY LEARNED ABOUT IT RIGHT HERE; RIGHT?

786

ADAM ROSENDORFF: THAT'S WHAT HE'S SAYING, YEAH.

787

MR. WADE: AND IT WAS YOUR PRACTICE?

789

MR. WADE: OKAY. AND YOU DID IT IN CONJUNCTION WITH A TEAM OF OTHER PEOPLE; RIGHT?

791

MR. WADE: DO YOU RECALL GIVING TESTIMONY ON DIRECT EXAMINATION ABOUT THE FREQUENCY OF DOCTOR QUESTIONS?

793

MR. WADE: OKAY. I WANT TO MAKE SURE THAT I UNDERSTAND YOUR TESTIMONY. DO YOU RECALL THAT MR. BOSTIC ASKED YOU ABOUT THE FREQUENCY OF THE PROBLEMS AND ASKED YOU TO COMPARE THEM WITH THE FREQUENCY OF PROBLEMS AT UNIVERSITY OF PITTSBURGH? DO YOU RECALL THAT?

795

MR. WADE: AND YOUR ANSWER WAS THAT THEY WERE MUCH MORE FREQUENT AT THERANOS; RIGHT?

797

MR. WADE: YOU PREVIOUSLY TESTIFIED ON EXACTLY THIS TOPIC, HAVE YOU NOT?

798

ADAM ROSENDORFF: I BELIEVE SO.

799

MR. WADE: YEAH. AND YOU GAVE EXACTLY THE OPPOSITE ANSWER ESSENTIALLY; RIGHT?

800

ADAM ROSENDORFF: I DON'T RECALL.

801

MR. WADE: OKAY. WELL, LET'S SEE IF WE CAN CLARIFY THIS. IF YOU GO IN THE YELLOW BINDER TO EXHIBIT 11000. DO YOU HAVE THAT IN FRONT OF YOU?

803

MR. WADE: AND IF YOU COULD LOOK AT PAGE 122?

805

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

807

MR. WADE: OKAY. AND THERE -- AND THAT WAS A DEPOSITION THAT YOU GAVE IN THE ARIZONA MATTER?

809

MR. WADE: AND WE'VE TALKED ABOUT THIS BEFORE. YOU WERE UNDER OATH; RIGHT?

811

MR. WADE: AND THERE WAS A COURT REPORTER THERE TAKING DOWN YOUR ANSWERS?

813

MR. WADE: UNDER THE PAINS AND PENALTIES OF PERJURY; CORRECT?

815

MR. WADE: OKAY. YOU WERE ASKED, "WERE THESE TYPE OF PHYSICIAN COMPLAINTS COMMON DURING YOUR TIME AT THERANOS?" AND YOU ANSWERED, "THEY WEREN'T MORE COMMON THAN WHAT ONE USUALLY SEES IN A -- SOME LABS WITH HIGH VOLUME." CORRECT?

816

JUDGE DAVILA: EXCUSE ME.

817

MR. BOSTIC: YOUR HONOR, THIS EXHIBIT IS NOT IN EVIDENCE. COUNSEL IS READING FROM IT.

818

MR. WADE: I'M IMPEACHING THE WITNESS, YOUR HONOR.

819

JUDGE DAVILA: YES, YOU ARE IMPEACHING THE WITNESS. DO YOU WANT TO ASK HIM WHETHER OR NOT -- I THINK YOU LAID A FOUNDATION FOR THIS, BUT YOU CAN ASK HIM WHETHER -- TO READ IT HIMSELF AND ASK IF THAT'S HIS RESPONSE. SO WHY DON'T YOU ASK YOUR QUESTION AGAIN?

820

MR. WADE: YOUR HONOR, I BELIEVE I ASKED --

821

JUDGE DAVILA: DO IT AGAIN.

822

MR. WADE: OKAY. OKAY.

823

MR. WADE: SIR, ON LINE 12 OF THIS TRANSCRIPT, YOU WERE ASKED, "WERE THESE TYPES OF PHYSICIAN COMPLAINTS COMMON DURING YOUR TIME AT THERANOS?"

825

MR. WADE: AND YOU WERE ASKED THAT; RIGHT?

827

MR. WADE: AND YOU ANSWERED, "THEY WEREN'T MORE COMMON THAN WHAT ONE USUALLY SEES IN A -- SOME LABS WITH HIGH VOLUME." CORRECT?

828

ADAM ROSENDORFF: YES. WE'VE SEEN BEFORE THAT THERANOS WAS NOT A HIGH VOLUME LAB.

829

MR. WADE: DO YOU SEE WHAT THAT SAYS THERE?

831

MR. WADE: DID I READ IT CORRECTLY?

833

MR. WADE: AND THEN YOU WERE ASKED, CAN YOU EXPLAIN THAT A LITTLE BIT MORE. DO YOU SEE THAT?

835

MR. WADE: AND YOU WERE ASKED THAT; CORRECT?

837

MR. WADE: AND YOU ANSWERED, YOU, YOU ALWAYS GET QUESTIONS AS LAB DIRECTOR?

839

MR. WADE: YOU CAN RUN A THOUSAND TESTS, AND THEN ONE OR TWO ARE SEEMINGLY PROBLEMATIC OR ANOMALOUS?

841

MR. WADE: THEY'RE FLYERS. YOU DON'T KNOW WHY THERE'S A DIFFERENCE BETWEEN THAT TEST AND A TEST DONE AT A DIFFERENT CENTER AND YOU -- I DON'T THINK THE TESTS, I DON'T THINK I HAD A GREATER NUMBER OF TESTS THAT, THAT WERE ANOMALOUS, THAT I HAD TO REVIEW AS LAB DIRECTOR AT THERANOS THAN AT OTHER PLACES THAT I'VE BEEN LIKE AT UNIVERSITY OF PITTSBURGH. CORRECT?

843

MR. WADE: OKAY. AND THAT WAS TRUTHFUL TESTIMONY ON THAT DAY; RIGHT?

845

MR. WADE: AND THAT WAS 180 DEGREES FROM WHAT YOU ANSWERED IN YOUR DIRECT TESTIMONY; RIGHT?

846

ADAM ROSENDORFF: YES, IT SEEMS TO BE DIFFERENT.

847

MR. WADE: NOW, THESE RESULTS WERE -- EVERY ONCE IN A WHILE PROBLEMS COME UP IN LABS; RIGHT?

849

MR. WADE: AND EVERY LAB IN AMERICA PROBABLY? PROBABLY EVERY LAB IN THE WORLD; RIGHT?

851

MR. WADE: IT'S NOT GOING TO BE PERFECT; CORRECT?

853

MR. WADE: OKAY. AND --

854

ADAM ROSENDORFF: SO KEEP IN MIND THAT UNIVERSITY OF PITTSBURGH HAD A MUCH, MUCH HIGHER VOLUME, SO THERANOS HAD A MUCH, MUCH LOWER VOLUME, SO ACTUALLY THE NUMBER OF COMPLAINTS AND ISSUES WERE COMPARABLE; RIGHT? SO I JUST WANTED TO POINT OUT. ACTUALLY THE HIGHER THE VOLUME, THE MORE ISSUES YOU WOULD EXPECT, BUT THERANOS WAS LOW VOLUME.

855

MR. WADE: SIR, YOU TESTIFIED ON YOUR DIRECT EXAMINATION THAT THERE WERE MUCH MORE FREQUENT ISSUES AT THERANOS; RIGHT?

857

MR. WADE: AND YOU TESTIFIED EXACTLY THE OPPOSITE IN YOUR DEPOSITION; RIGHT?

858

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

859

MR. WADE: OKAY. WHEN AN ISSUE DID COME UP, DID YOU INVESTIGATE IT?

860

ADAM ROSENDORFF: YES, OF COURSE.

861

MR. WADE: AND, IN FACT, THERE'S A REGULATION THAT REQUIRES YOU TO INVESTIGATE IT; RIGHT?

862

ADAM ROSENDORFF: I'M NOT SURE EXACTLY WHICH ONE YOU'RE REFERRING TO, BUT --

863

MR. WADE: A STANDARD FOR COMPLAINT INVESTIGATIONS?

865

MR. WADE: ARE YOU FAMILIAR WITH THAT UNDER CLIA?

867

MR. WADE: AND WOULD YOU FOLLOW THAT?

869

MR. WADE: AND YOU HAD SOP'S ON THAT; CORRECT?

870

ADAM ROSENDORFF: I BELIEVE SO.

871

MR. WADE: LET'S LOOK AT 9907.

873

MR. WADE: AND THIS IS THE COMPLAINT INVESTIGATION AND COMMUNICATION POLICY AT THERANOS?

874

ADAM ROSENDORFF: OH, OKAY, 2011.

875

MR. WADE: IS THAT RIGHT?

876

ADAM ROSENDORFF: IT'S DATED 2011.

877

MR. WADE: AND THIS IS THE STANDARD FORMAT IN WHICH THESE CONTROLLED DOCUMENTS WERE MAINTAINED?

879

MR. WADE: I MOVE THE ADMISSION OF EXHIBIT 9907.

880

MR. BOSTIC: NO OBJECTION.

881

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

882

(DEFENDANT'S EXHIBIT 9907 WAS RECEIVED IN EVIDENCE.)

883

BY MR. WADE:

884

MR. WADE: AND IF WE COULD JUST GO TO THE THIRD PAGE, THERE'S A SPECIFIC PROCESS THAT IS SET FORTH IN HERE FOR HOW THESE THINGS ARE TO BE HANDLED; CORRECT?

886

MR. WADE: AND RESPONSIBILITIES; CORRECT?

888

MR. WADE: AND THERE IT SAYS, LIKE MANY OF THESE RESPONSIBILITIES IN THE CLIA LAB, THAT YOU'RE ULTIMATELY RESPONSE; CORRECT?

890

MR. WADE: I DON'T HAVE ANY MORE QUESTIONS ON THAT DOCUMENT. DO YOU RECALL BEING ASKED SOME QUESTIONS ABOUT C02 OR BICARBONATE?

892

MR. WADE: AND LET'S GO THROUGH THAT TESTIMONY. THAT IS EXHIBIT 4116, WHICH I BELIEVE IS IN EVIDENCE.

894

MR. WADE: DO YOU RECALL THIS? YOU WERE ASKING -- THE GOVERNMENT ASKED YOU ABOUT THIS PORTION OF THE DOCUMENT IN THE MIDDLE HERE. DO YOU RECALL THIS?

896

MR. WADE: AND YOU WERE ASKED IF THIS COULD BE A PROBLEM, RIGHT, THE LEAKAGE OF C02? YOU WERE ASKED THAT?

897

ADAM ROSENDORFF: THE GOVERNMENT --

898

MR. WADE: YEAH, DO YOU REMEMBER THE GOVERNMENT ASKING YOU ABOUT THAT?

900

MR. WADE: AND ASKED YOU TO EXPLAIN THE KIND OF PROBLEMS?

902

MR. WADE: AND YOU SAID -- YOU INDICATED THAT IT COULD BE A LUNG PROBLEM; RIGHT? DO YOU RECALL THAT?

903

ADAM ROSENDORFF: THEY WERE ASKING ME ABOUT THE MEDICAL IMPORTANCE OF BICARBONATE, AND I SAID IT COULD INDICATE A LUNG PROBLEM, YEAH.

904

MR. WADE: AND YOU NOTED THAT THIS WAS A HIGH IMPORTANCE DOCUMENT; RIGHT?

906

MR. WADE: OKAY. AND YOU TALKED ABOUT SOME INFORMATION THAT HAD COME UP AS A RESULT OF CURTIS SCHNEIDER'S STUDY. DO YOU RECALL THAT?

908

MR. WADE: AND DO YOU RECALL -- YOU WERE ASKED WHETHER YOU VIEWED THIS AS A PROBLEM?

910

MR. WADE: AND YOU SAID, I THOUGHT IT WAS A PROBLEM, AND YOU DIDN'T RECALL IF MANAGEMENT THOUGHT IT WAS A PROBLEM; RIGHT?

912

MR. WADE: DO YOU RECALL THAT? OKAY. DO YOU SEE -- LET'S SEE IF MANAGEMENT THOUGHT IT WAS A PROBLEM. GO UP ONE EMAIL. DO YOU SEE MR. BALWANI FORWARDS THIS TO DR. PATEL AND MR. ANEKAL? DO YOU SEE THAT?

914

MR. WADE: AND YOU HAD ACTUALLY SUGGESTED THAT YOU WERE WONDERING IF DR. PATEL HAD ANY DATA ON THIS. DO YOU RECALL THAT FROM THE EMAIL BELOW?

915

ADAM ROSENDORFF: I'M SORRY, I DON'T RECALL.

916

MR. WADE: WELL, TAKE A LOOK.

917

ADAM ROSENDORFF: OH, I SEE. I SEE. OKAY.

918

MR. WADE: DO YOU SEE THAT?

920

MR. WADE: AND YOU WERE ASKING IF THERE WAS ANY WORK, RIGHT --

922

MR. WADE: -- DONE ON THAT? AND MR. BALWANI WAS FOLLOWING UP; RIGHT?

924

MR. WADE: OKAY. AND LET'S LOOK ACTUALLY DOWN AT YOUR EMAIL BELOW. LET'S BLOW UP THE BOTTOM THIRD OF YOUR EMAIL BELOW, SOME PIECES THE GOVERNMENT DIDN'T FOCUS ON. YOU SEE WHERE IT SAYS THAT PHYSICIANS ARE AWARE THAT IF THEY WANT AN ACCURATE BICARB READING, THEY NEED TO GET THE SAMPLE TO THE LAB STAT. DO YOU SEE THAT?

926

MR. WADE: AND THAT'S BECAUSE THERE CAN BE LEAKAGE OVER TIME AND IF A DOCTOR WANTS -- HAS A CONCERN THAT IS FOCUSSED ON BICARBONATE, THEY MIGHT GO TO A STAT LAB; RIGHT?

927

ADAM ROSENDORFF: THAT'S WHAT I SAID AT THE TIME, YES.

928

MR. WADE: THAT'S WHAT YOU SAID. AND THEN IN THE NEXT SENTENCE YOU SAID, "SO FAR WE HAVE NOT HAD ANY CALLS REGARDING BICARB VALUES." DO YOU SEE THAT?

930

MR. WADE: AND YOU SAY YOU THINK DOCTORS KNOW THAT IT'S HIGHLY CONTEXT-DEPENDENT ASSAY. DO YOU SEE THAT?

932

MR. WADE: OKAY. LET'S GO TO EXHIBIT 12587.

934

MR. WADE: AND DO YOU RECOGNIZE THAT THIS IS A DIFFERENT EMAIL CHAIN ON THE SAME ISSUE?

936

MR. WADE: AND THE GOVERNMENT DIDN'T SHOW YOU THIS CHAIN, DID THEY?

938

MR. WADE: OKAY. LET'S GO TO THE BACK.

940

MR. WADE: DO YOU SEE IT?

942

MR. WADE: OH, I'M SORRY. THIS IS NOT IN EVIDENCE. YOUR HONOR, I MOVE THE ADMISSION OF 12587.

943

MR. BOSTIC: NO OBJECTION.

944

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

945

(DEFENDANT'S EXHIBIT 12587 WAS RECEIVED IN EVIDENCE.)

946

MR. WADE: WE'LL GO TO THE LAST PAGE.

947

MR. WADE: SO WE CAN ORIENT YOU AND THE JURY, THIS IS THE EMAIL THAT WE WERE JUST TALKING ABOUT, EXHIBIT 4116; RIGHT?

949

MR. WADE: IT'S THE SAME EMAIL; RIGHT?

951

MR. WADE: OKAY. AND THEN IF YOU GO -- AND THIS IS MARCH 31ST, 2014 AT 12:38 P.M. DO YOU SEE THAT?

953

MR. WADE: OKAY. AND IF YOU GO UP, YOU SEE MR. BALWANI RESPONDS IN ABOUT 11 MINUTES. DO YOU SEE THAT?

955

MR. WADE: AND HE TALKS ABOUT ALL OF THE DATA AND SUGGESTS DIGGING INTO THE ISSUE; IS THAT FAIR?

957

MR. WADE: AND YOU DO, TOO. YOU RESPOND ALMOST IMMEDIATELY. AND YOU NOTE THAT YOU WERE GOING TO HAVE LANGLY REVIEW YOUR LEVEY-JENNINGS DATA. DO YOU SEE THAT?

959

MR. WADE: FOR BOTH ADVIA'S. DO YOU SEE THAT?

961

MR. WADE: AND THAT'S TO LOOK IF THERE'S A TREND IN THE QC; RIGHT?

963

MR. WADE: LET'S GO UP THE CHAIN. YOU THEN REPORT THAT YOU'VE DUG IN SOME MORE; RIGHT?

965

MR. WADE: AND YOU'VE ACTUALLY GONE BACK AND COMPARED SOME OF THAT DATA TO THE DATA IN THE VALIDATION REPORT; RIGHT?

967

MR. WADE: AND YOU SAY IN THAT SECOND PARAGRAPH, "BASED ON THIS INFORMATION, I SUGGEST A NEW BICARBONATE REFERENCE RANGE FOR OUR METHOD." DO YOU SEE THAT?

969

MR. WADE: AND THEN THIS IS THE SAME DAY; RIGHT?

971

MR. WADE: EIGHT HOURS LATER?

973

MR. WADE: OKAY. AND THEN YOU ACTUALLY THEN CLARIFY IN THE EMAIL RIGHT ABOVE. OKAY. IT SAYS, "PARDON ME I MEANT 'BIAS OBSERVED BETWEEN PREDICATE AND THERANOS METHODS.'" DO YOU SEE THAT?

975

MR. WADE: AND SO THIS IS ONE OF THE AREAS WHERE THERE'S A BIAS THAT YOU CAN CORRECT FOR; RIGHT?

976

ADAM ROSENDORFF: IT DEPENDS ON THE REPRODUCIBILITY OF THE ASSAY.

978

ADAM ROSENDORFF: IF THE ASSAY IS NOT REPRODUCIBLE, THEN BIAS CORRECTION IS NOT APPROPRIATE.

979

MR. WADE: BUT YOU WERE DIGGING IN ON THIS AND YOU WERE MAKING A SUGGESTION ON HOW TO DEAL WITH THIS TO THE TEAM; RIGHT?

981

MR. WADE: OKAY. AND LET'S GO UP THE CHAIN. DR. YOUNG REPORTS SOME INFORMATION, TOO, BASED ON HIS WORK; RIGHT?

983

MR. WADE: AND THEN IT SAYS, "THE DATA FROM OUR IN-HOUSE AAP DRY RUNS (NOW 7 DAYS OF TESTING) LOOKS OK OVERALL." DO YOU SEE THAT?

985

MR. WADE: AND THIS IS MARCH 31ST, 2014?

987

MR. WADE: AND WITH ABOUT A 90 PERCENT RECOVERY. DO YOU SEE THAT?

989

MR. WADE: AND THEN IT SAYS, "WITH A FEW MORE DAYS OF TESTING, I THINK WE WILL HAVE A GOOD DATA SET FROM WHICH TO MAKE A DECISION." DO YOU SEE THAT?

990

ADAM ROSENDORFF: THE ISSUE WITH C02 IS THE DELAY BETWEEN THE COLLECTION AND WHEN IT ARRIVES IN THE LAB. SO WHEN YOU DO A STUDY, THERE IS NO DELAY.

991

MR. WADE: AND I'M JUST ASKING IF YOU SEE WHAT HE WROTE THERE IN TERMS OF WHAT HE WAS REPORTING OUT. DO YOU SEE THAT?

993

MR. WADE: AND DO YOU SEE THAT HE SAYS, MOVING FORWARD, "WE WILL APPLY A BIAS CORRECTION FOR C02 FINGERSTICK SAMPLES SUCH THAT WE REPORT THE RESULTS IN THE VENOUS EQUIVALENT CONCENTRATION." DO YOU SEE THAT?

995

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

996

ADAM ROSENDORFF: I DON'T KNOW WHAT IT MEANS, BUT I SEE IT, YEAH.

997

MR. WADE: WELL, LET'S SEE HOW YOU RESPOND.

999

MR. WADE: AND YOU SAY "OK THANKS -- SO I GUESS THE 90 PERCENT RECOVERY IS AFTER BIAS CORRECTION -- IF THIS IS THE CASE THEN 20 NORMALS MOST LIKELY WOULD BE IN THE PREDICATE RANGE." DO YOU SEE THAT?

1001

MR. WADE: AND IF YOU GO UP ONE MORE TIME, YOU RESPOND AGAIN. YOU ASK DANIEL TO LET YOU KNOW WHEN THIS CORRECTION IS IMPLEMENTED; RIGHT?

1003

MR. WADE: AND SO THIS ISSUE WAS ADDRESSED IN ABOUT 24 HOURS?

1004

ADAM ROSENDORFF: I DON'T KNOW.

1005

MR. WADE: WELL, LOOK AT THE TIME OF THE EMAIL ON THE LAST PAGE. IT WAS 12:38. DO YOU SEE THAT?

1007

MR. WADE: OKAY. AND ON MARCH 31ST, DO YOU SEE THAT? AND THEN MAYBE IT WAS 32 HOURS. YOU CAN LOOK AT THE EMAIL ON THE FIRST PAGE.

1009

MR. WADE: OKAY. SO JUST SO WE'RE CLEAR, NO DOCTORS RAISE ISSUES ON THIS; RIGHT?

1011

MR. WADE: AND THE ASSAY IS VERY CONTEXT DEPENDENT ACCORDING TO YOU; RIGHT?

1013

MR. WADE: AND DOCTORS KNOW THAT IT'S IMPORTANT THAT A STAT LAB WILL PROBABLY BE USED. THAT'S WHAT YOU SAID; RIGHT?

1015

MR. WADE: AND YOU AND DR. YOUNG WORKED TOGETHER TO RESOLVE THIS IN ABOUT A DAY; RIGHT?

1016

ADAM ROSENDORFF: I CAN'T SAY THAT IT WAS RESOLVED. I CAN'T ANSWER YOU YES OR NO.

1017

MR. WADE: DO YOU SEE THAT HE'S ASKING IN THE EMAIL WHEN IS HE GOING TO PUT THAT FIX INTO THE SYSTEM?

1019

MR. WADE: AND THAT MEANS SO THAT YOU CAN REPORT RESULTS; RIGHT?

1021

MR. WADE: AND SO YOU THOUGHT AT THAT POINT, WITHIN A DAY, IT WAS SAFE AND APPROPRIATE TO REPORT RESULTS --

1022

ADAM ROSENDORFF: BASED ON THE DATA -- I'M SORRY.

1023

MR. WADE: LET ME FINISH THE QUESTION AND THEN WE'LL LET YOU ANSWER MY QUESTION. OKAY?

1025

MR. WADE: JUST SO THE COURT REPORTER DOESN'T GO CRAZY HERE. OKAY. SO ON THAT DAY, YOU WERE COMFORTABLE WITH THE APPROACH AND YOU ASKED WHEN IT WAS GOING TO BE IMPLEMENTED SO RESULTS COULD BE REPORTED; CORRECT?

1026

ADAM ROSENDORFF: I WAS REVIEWING DANIEL'S STUDY, AND BASED ON HIS STUDY, I BELIEVED THAT IT WAS NOW FIXED.

1027

MR. WADE: AND YOU WERE ASKING WHEN IT WAS GOING TO BE IMPLEMENTED BECAUSE YOU BELIEVED IT WAS SAFE TO REPORT RESULTS AS A RESULT OF THAT APPROACH; CORRECT?

1029

MR. WADE: OKAY. AND THAT WAS DONE IN PART REFERENCING THE IN-HOUSE AAP DRY RUNS; CORRECT?

1031

MR. WADE: I'D LIKE TO SHOW YOU EXHIBIT 1772. IT'S ON YOUR SCREEN, AND IT'S IN EVIDENCE. IF WE CAN BLOW UP THE TOP TWO EMAILS. THIS RELATES TO SOME BACKLOGS THAT EXISTED ON EDISONS. DO YOU RECALL THAT?

1033

MR. WADE: AND YOU WERE ASKED SOME QUESTIONS ABOUT THIS AND ABOUT SUNNY'S RESPONSE. DO YOU RECALL THAT?

1035

MR. WADE: OKAY. DID YOU BELIEVE THE RESPONSE WAS A LITTLE CURT?

1036

ADAM ROSENDORFF: I DON'T REMEMBER HOW SUNNY RESPONDED.

1037

MR. WADE: OKAY. BUT YOU -- THE GOVERNMENT ASKED YOU ABOUT THIS DOCUMENT. DO YOU RECALL THEM ASKING ABOUT THIS?

1039

MR. WADE: OKAY. LET'S -- AND THIS IS AN EMAIL -- YOU SEE YOUR EMAIL IS JUNE 11TH, 2014, 5:25 P.M.?

1041

MR. WADE: DO YOU SEE THAT? LET'S LOOK AT 13888. THAT'S NOT IN EVIDENCE, SO I'LL HAVE TO IMPOSE UPON YOU TO FIND THAT ONE IN THE BINDER.

1042

MR. DOWNEY: YOUR HONOR, MAY I JUST CONSULT WITH MR. WADE FOR JUST A MOMENT?

1043

(DISCUSSION OFF THE RECORD.)

1044

MR. DOWNEY: THANK YOU, YOUR HONOR.

1045

ADAM ROSENDORFF: OKAY, I HAVE IT.

1046

BY MR. WADE:

1047

MR. WADE: DO YOU RECOGNIZE THIS TO BE A DIFFERENT EMAIL ON THAT SAME ISSUE?

1049

MR. WADE: OKAY. I MOVE THE ADMISSION OF 13888.

1050

MR. BOSTIC: NO OBJECTION.

1051

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

1052

(DEFENDANT'S EXHIBIT 13888 WAS RECEIVED IN EVIDENCE.)

1053

BY MR. WADE:

1054

MR. WADE: AND DO YOU SEE YOUR EMAIL RAISING THIS DOWN AT THE BOTTOM?

1056

MR. WADE: OKAY. BUT THERE'S A DIFFERENT RESPONSE UP AT THE TOP; RIGHT? DIFFERENT FROM EXHIBIT 1772 THAT THE GOVERNMENT ASKED YOU ABOUT; RIGHT?

1057

ADAM ROSENDORFF: I'M SORRY. ARE YOU --

1058

MR. WADE: WELL, LET'S BLOW UP THE TOP HERE. DO YOU RECALL THAT IN THE PRIOR VERSION OF THIS DOCUMENT THERE WAS AN EMAIL WHERE THEY SAID THAT WE NEED TO RESOLVE THIS -- WE NEED THIS MESS RESOLVED ASAP. DO YOU RECALL THAT?

1060

MR. WADE: OKAY. THIS ACTUALLY IS A DIFFERENT RESPONSE TO YOUR EMAIL, ISN'T IT, A SEPARATE RESPONSE?

1062

MR. WADE: AND IT'S JUST TO YOU PERSONALLY; CORRECT?

1064

MR. WADE: AND THE GOVERNMENT DIDN'T SHOW YOU THIS ONE, DID THEY?

1066

MR. WADE: AND I JUST WANT TO DRAW YOUR ATTENTION, DO YOU SEE IN THE END THERE HE SAYS, MR. BALWANI SAYS, "IN THE MEANTIME WE WILL PUSH TO GET MORE DEVICES DONE." DO YOU SEE THAT?

1068

MR. WADE: "AND THE DRIVING FACTOR WILL BE NO BACKLOG OR DELAY IN PATIENT SAMPLES." DO YOU SEE THAT?

1070

MR. WADE: AND HE WAS GOING TO DO WHAT YOU ASKED HIM TO DO, RIGHT, TO STOP ALIQUOTING THE SAMPLES; RIGHT?

1072

MR. WADE: AND YOU THANKED HIM FOR THAT?

1074

MR. WADE: YOUR HONOR, NOW MIGHT BE A GOOD TIME FOR A BREAK.

1075

JUDGE DAVILA: LET'S DO THAT. LET'S TAKE OUR BREAK, LADIES AND GENTLEMEN. LET'S TAKE ABOUT 45 MINUTES. I THINK 45 MINUTES WILL BE GOOD NOW. WE'LL TAKE OUR BREAK. I THINK I MENTIONED WE WOULD GO UNTIL 3:00 P.M. THIS AFTERNOON. THAT'S MY RECOLLECTION. DOES THAT CAUSE A PROBLEM FOR ANYONE? IF SO, LET ME SEE A HAND. THANKS SO MUCH. ENJOY YOUR BREAK. WE'LL SEE YOU IN ABOUT 45 MINUTES.

1076

(JURY OUT AT 11:07 A.M.)

1077

JUDGE DAVILA: THANK YOU. DOCTOR, YOU CAN STAND DOWN AND TAKE A BREAK AS WELL. PLEASE BE SEATED. THANK YOU. OUR JURY HAS LEFT THE COURTROOM. ALL COUNSEL ARE PRESENT. THE WITNESS HAS LEFT THE COURTROOM. ANYTHING FURTHER BEFORE WE TAKE OUR BREAK? FROM THE PROSECUTION?

1078

MR. BOSTIC: NO, YOUR HONOR.

1079

MR. DOWNEY: NO, YOUR HONOR.

1080

JUDGE DAVILA: ALL RIGHT. THANK YOU. IT MAY BE THAT I WON'T BE ABLE TO ENGAGE THE JURY AS I SAID REGARDING THEIR QUESTIONNAIRES. AS YOU RECALL, MY PLAN WAS TO LET THEM KNOW THAT PRIOR TO THE BREAK AND GIVE THEM THEIR QUESTIONNAIRES SO THEY CAN LOOK AT THEM OVER THE COURSE OF THEIR BREAK. GIVEN OUR TIMING AND OUR DISCUSSION THIS MORNING, I DON'T THINK THAT'S GOING TO BE APPROPRIATE TODAY. I DON'T THINK WE'LL HAVE TIME TO DO THAT TODAY. I'M GOING TO HAVE TO ENGAGE THAT NEXT WEEK IN A DIFFERENT SCHEDULE, I THINK. I DON'T THINK WE CAN GET IT DONE TOMORROW AS WELL. BUT WE'LL SEE WHAT TOMORROW BRINGS. OKAY. THANK YOU.

1081

MR. DOWNEY: THANK YOU.

1082

COURT CLERK: COURT IS IN RECESS.

1083

(LUNCH RECESS TAKEN AT 11:08 A.M.) AFTERNOON SESSION

1084

(JURY IN AT 11:56 A.M.)

1085

JUDGE DAVILA: THANK YOU. WE'RE BACK ON THE RECORD. ALL OF THE PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. OUR JURY IS PRESENT. DR. ROSENDORFF IS ON THE STAND AGAIN. YOU HAVE QUESTIONS?

1086

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

1087

MR. WADE: DR. ROSENDORFF, I HAVE A COUPLE OF QUESTIONS ABOUT THE T PROTOCOLS.

1089

MR. WADE: SO WE'RE ALL ON THE SAME PAGE, THOSE WERE THE MODIFIED ADVIA ASSAYS?

1091

MR. WADE: AND THOSE WERE LAB DEVELOPED TESTS?

1093

MR. WADE: AND THE SIEMENS ADVIA HAD OPEN CHANNELS FOR LAB DEVELOPED TESTS?

1095

MR. WADE: AND AT THE TIME THESE WERE BEING PUT ON TO THE ADVIA, THERE WERE NO COMMERCIALLY AVAILABLE FINGERSTICK TESTS THAT COULD BE RUN ON THE ADVIA; CORRECT?

1097

MR. WADE: AND THERE WERE SOME QUESTIONS ASKED ON DIRECT EXAMINATION ABOUT THESE PROTOCOLS. DO YOU RECALL SOME OF THOSE QUESTIONS GENERALLY?

1099

MR. WADE: OKAY. BUT WITH THE EXCEPTION OF POTASSIUM, THOSE ADVIA PROTOCOLS WORKED REMARKABLY WELL, DIDN'T THEY?

1100

ADAM ROSENDORFF: ARE YOU REFERRING TO THE PREDICATE OR THE THERANOS ASSAYS?

1101

MR. WADE: THE T PROTOCOLS RUNNING ON THE ADVIA'S WORKED REMARKABLY WELL, WITH THE EXCEPTION OF POTASSIUMS; CORRECT?

1103

MR. WADE: DO YOU RECALL TELLING THE GOVERNMENT, THE S.E.C., ONE OF THE PROSECUTORS AND SOME OF THE AGENTS IN THIS CASE IN JUNE OF 2017 THAT WITH THE EXCEPTION OF POTASSIUM, THE T PROTOCOLS WITH THE FINGERSTICK DRAW WORKED REMARKABLY WELL?

1104

ADAM ROSENDORFF: NO, I DON'T RECALL.

1105

MR. WADE: IF YOU COULD GO TO THE YELLOW BINDER, EXHIBIT 11004. DO YOU HAVE THAT MEMORANDUM OF INTERVIEW IN FRONT OF YOU?

1107

MR. WADE: IF YOU COULD GO TO THE FIFTH PAGE AND GO TO THE LAST PARAGRAPH ON THE BOTTOM OF THAT PAGE AND READ IT TO YOURSELF AND JUST TELL ME WHEN YOU'RE DONE READING IT.

1108

ADAM ROSENDORFF: YES, I'M DONE READING IT.

1109

MR. WADE: DOES READING THAT PARAGRAPH REFRESH YOUR RECOLLECTION THAT YOU TOLD THE S.E.C. AND THESE GOVERNMENT LAWYERS THAT THE T PROTOCOL AND FINGERSTICK DRAW WORK REMARKABLY WELL FOR MOST ANALYTES?

1110

ADAM ROSENDORFF: I DON'T HAVE AN INDEPENDENT RECOLLECTION. I'M READING IT NOW.

1111

MR. WADE: DOES IT REFRESH YOUR RECOLLECTION, SIR, THAT YOU TOLD THEM THAT?

1113

MR. WADE: I'D LIKE TO ASK YOU SOME QUESTIONS ABOUT YOUR DEPARTURE FROM THE COMPANY. I BELIEVE THAT YOUR TESTIMONY WAS THAT YOU STARTED LOOKING FOR A JOB IN THE MIDDLE OF 2013; CORRECT?

1114

ADAM ROSENDORFF: I WAS LOOKING AROUND, YES.

1115

MR. WADE: YEAH. YOU WERE LOOKING AROUND FOR OTHER JOBS IN THE MIDDLE OF 2013; RIGHT?

1117

MR. WADE: AND YOU WENT ON THE CLIA LAB CERTIFICATE AS A LAB DIRECTOR STARTING IN JUNE OF 2013; RIGHT?

1119

MR. WADE: RIGHT. LET'S JUST -- SO WE HAVE IT IN EVIDENCE, LET'S LOOK AT 13887, WHICH SHOULD BE IN ONE OF YOUR BLACK EXHIBIT BINDERS.

1121

MR. WADE: AND THIS IS A COPY OF YOUR CLINICAL LABORATORY LICENSE?

1123

MR. WADE: FOR THERANOS?

1125

MR. WADE: I MOVE THE ADMISSION OF 13887.

1126

MR. BOSTIC: NO OBJECTION.

1127

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

1128

(DEFENDANT'S EXHIBIT 13887 WAS RECEIVED IN EVIDENCE.)

1129

MR. WADE: IF WE CAN PULL UP THE BOTTOM HALF.

1130

MR. WADE: THIS NOTES THAT IN JUNE OF 2013 YOU WENT ON TO THE CLIA CERTIFICATE ALONG WITH SPENCER HIRAKI; CORRECT?

1132

MR. WADE: AND A LITTLE BIT LATER THAT YEAR, YOU BECAME THE ONLY PERSON ON THE CLIA CERTIFICATE; RIGHT?

1134

MR. WADE: AND I THINK WE DISCUSSED THAT THE SOFT LAUNCH AT WALGREENS FOR FRIENDS AND FAMILY WAS IN SEPTEMBER OF 2013?

1136

MR. WADE: AND SO YOU STARTED LOOKING FOR A JOB BEFORE ANY PATIENT TESTS WERE PERFORMED AT THERANOS?

1138

MR. WADE: YOU ESSENTIALLY HAD A FOOT OUT THE DOOR THE WHOLE TIME; IS THAT RIGHT?

1139

ADAM ROSENDORFF: I CAN'T ANSWER YES OR NO. I WAS VERY COMMITTED TO MY JOB AS LAB DIRECTOR AT THERANOS.

1140

MR. WADE: BUT YOU WERE DEDICATED TO TRYING TO FIND A DIFFERENT JOB; CORRECT?

1141

ADAM ROSENDORFF: ON OCCASION I WOULD LOOK AT WHAT JOBS WERE AVAILABLE.

1142

MR. WADE: AND THAT WAS BEFORE ANY OF THESE ISSUES THAT YOU TALKED ABOUT ON DIRECT EXAMINATION; CORRECT?

1144

MR. WADE: AND I BELIEVE YOU ALSO TESTIFIED THAT STARTING IN MAY OF 2013, OR THEREABOUTS, YOU WERE CONSIDERING A QUI TAM LAWSUIT; IS THAT CORRECT?

1146

MR. WADE: AND JUST SO -- THAT'S KIND OF AN INTERESTING WORD. JUST FOR THE BENEFIT OF THE JURY, A QUI TAM LAWSUIT IS ONE WHERE YOU WOULD TRY TO RECOVER MONEY FROM THERANOS; RIGHT?

1147

ADAM ROSENDORFF: IT'S A LAWSUIT WHERE I WOULD BE ALERTING THE GOVERNMENT TO A FALSE CLAIM ON BEHALF OF -- I WOULD BE A RELATOR AND WOULD BE ALERTING THE GOVERNMENT TO WRONGDOING AT THERANOS.

1148

MR. WADE: RIGHT. AND IN EXCHANGE FOR YOUR FILING A QUI TAM LAWSUIT, IF THERE'S A RECOVERY, YOU WOULD GET BETWEEN 15 AND 25 PERCENT OF THE MONEY FROM THAT RECOVERY; RIGHT?

1149

ADAM ROSENDORFF: YES. BUT I KNEW THAT THERANOS DIDN'T HAVE A LOT OF MEDICARE WORK.

1151

ADAM ROSENDORFF: IT WAS A WAY OF ALERTING THE GOVERNMENT TO WHAT WAS GOING ON. THAT'S HOW I VIEWED IT.

1152

MR. WADE: SIR, YOU'RE AWARE THAT A QUI TAM LAWSUIT IS A LAWSUIT WHERE YOU WOULD GET 15 TO 25 PERCENT?

1153

ADAM ROSENDORFF: I DON'T KNOW THE EXACT PERCENTAGES. I DIDN'T LOOK INTO THAT.

1154

MR. WADE: BUT YOU KNOW THAT YOU GET A PERCENTAGE OF RECOVERY OF MONEY THAT WOULD COME BACK?

1155

ADAM ROSENDORFF: RIGHT, YES, THERE'S A FINANCIAL AWARD.

1156

MR. WADE: AND YOU WERE TALKING TO LAWYERS ABOUT THAT LAWSUIT; RIGHT?

1158

MR. WADE: AND THOSE LAWYERS ARE NOT PAID ON AN HOURLY BASIS; CORRECT?

1159

ADAM ROSENDORFF: I PAID THE LAWYERS, PAID THOSE LAWYERS OUT OF MY OWN POCKET.

1160

MR. WADE: OKAY. BUT THEY GENERALLY GET A PERCENTAGE OF THE RECOVERY AS WELL; RIGHT?

1161

ADAM ROSENDORFF: I DON'T KNOW HOW THAT ARRANGEMENT WORKS.

1162

MR. WADE: OKAY. AND THEY NEVER FILED A QUI TAM LAWSUIT; CORRECT?

1164

MR. WADE: AND YOU SAY THAT YOU WANTED TO ALERT THE GOVERNMENT. YOU ACTUALLY HAD A CONVERSATION IN OCTOBER OF 2014, OR IN THE FALL OF 2014, WITH GARY YAMAMOTO OF CMS; CORRECT?

1165

ADAM ROSENDORFF: YES, THAT'S CORRECT.

1166

MR. WADE: AND MR. YAMAMOTO IS ONE OF THE SENIOR PEOPLE FOR THE STATE OF CALIFORNIA AT CMS?

1167

ADAM ROSENDORFF: HE'S THE INSPECTOR, YES, AND I DON'T KNOW HIS SENIORITY LEVEL.

1168

MR. WADE: OKAY. AND YOU HAD A CONVERSATION WITH HIM WHERE YOU SOUGHT GUIDANCE FOR HOW TO REPORT RESULTS FOR THERANOS'S LDT'S; RIGHT?

1169

ADAM ROSENDORFF: I BELIEVE THE DISCUSSION WAS ABOUT PROFICIENCY TESTING. I -- YEAH.

1170

MR. WADE: AND YOU -- WAS THAT IN SEPTEMBER OF 2014?

1171

ADAM ROSENDORFF: I DON'T RECALL.

1172

MR. WADE: OKAY. AND YOU CALLED TO CONSULT WITH HIM ON THERANOS'S WORK ON THAT; RIGHT?

1174

MR. WADE: AND YOU SOUGHT GUIDANCE FROM HIM ON THAT?

1176

MR. WADE: AND CMS TOLD YOU, JUST WAIT UNTIL THE NEXT INSPECTION; RIGHT?

1178

MR. WADE: AND IN THAT MEETING WHERE YOU HAD GARY YAMAMOTO ON THE PHONE, DID YOU RAISE ANY OF THESE OTHER ISSUES WITH HIM?

1180

MR. WADE: NO. OKAY. THAT WOULD HAVE BEEN A PRETTY EASY WAY TO ALERT THE GOVERNMENT; RIGHT? YOU HAD HIM ON THE PHONE, RIGHT, SIR?

1182

MR. WADE: WE TALKED ABOUT YOUR SAYING THE REASON THAT YOU LEFT RELATED TO AAP; CORRECT?

1184

MR. WADE: DO YOU REMEMBER THAT? AND LAST WEEK WE WALKED THROUGH THAT CHRONOLOGY A BIT IN THE FALL OF 2014. DO YOU RECALL THAT?

1186

MR. WADE: AND THERE WAS A MEETING IN 2014; RIGHT?

1188

MR. WADE: AND I BELIEVE YOU TESTIFIED AT SOME POINT YOU LEFT UNSATISFIED. YOU THOUGHT IT WAS LIP SERVICE?

1190

MR. WADE: OKAY. THAT WAS, THAT WAS THE MEETING THAT YOU ASKED FOR; RIGHT?

1192

MR. WADE: OKAY. AND THAT WAS THE MEETING THAT WAS SET FOR THE DAY AFTER YOU ASKED FOR IT, RIGHT, ON OCTOBER 10TH?

1193

ADAM ROSENDORFF: I BELIEVE SO.

1194

MR. WADE: OKAY. AND YOU WERE GIVEN -- YOUR TESTIMONY, I BELIEVE, WAS A CHANCE TO RAISE ALL OF YOUR CONCERNS IN THAT MEETING; CORRECT?

1196

MR. WADE: AND THERE WERE NO LIMITATIONS PLACED ON YOU IN THAT MEETING; RIGHT?

1198

MR. WADE: AND, IN FACT, YOU WERE -- YOU ACTUALLY RESCHEDULED THAT MEETING FOR A WEEK AFTER?

1200

MR. WADE: AND THERE WAS A FOLLOW-UP MEETING THAT YOU CANCELLED BECAUSE YOU DIDN'T HAVE ANYTHING ELSE TO RAISE. DO YOU RECALL THAT?

1202

MR. WADE: AND DO YOU RECALL THAT THERE WERE ACTIONS --

1203

ADAM ROSENDORFF: I DIDN'T THINK ANYTHING FURTHER WOULD BE ACCOMPLISHED WITH ANOTHER MEETING.

1204

MR. WADE: BUT YOU RECALL THAT THERE WERE ACTIONS ALMOST IMMEDIATELY COMING OUT OF THAT MEETING WHERE YOU WERE ENGAGING WITH MR. ARINGTON ON THOSE ISSUES? DO YOU RECALL THAT?

1205

ADAM ROSENDORFF: MR. ARINGTON WAS PRESENT AT THAT MEETING. I DON'T KNOW WHAT YOU MEAN BY ACTIONS.

1206

MR. WADE: WELL, DO YOU RECALL SENDING AN EMAIL AFTER THAT SET FORTH EXACTLY WHAT NEEDED TO BE DONE WITH RESPECT TO THE ANALYTES? DO YOU RECALL THAT?

1207

ADAM ROSENDORFF: I BELIEVE SO.

1208

MR. WADE: OKAY. AND THAT WAS THE DAY AFTER THE MEETING?

1210

MR. WADE: OR TWO DAYS. WITHIN A DAY OR TWO AFTER THE MEETING; RIGHT?

1212

MR. WADE: BUT YOU MAINTAINED THE VIEW THAT THERE WEREN'T ENOUGH RESOURCES THAT WERE DEDICATED TO THAT; RIGHT?

1214

MR. WADE: AND YOU'VE SEEN A LOT OF EMAILS IN YOUR NINE OR SO APPEARANCES IN THIS CASE. HAVE YOU EVER SEEN A SINGLE EMAIL WHERE YOU ASKED FOR RESOURCES ON AAP FROM MS. HOLMES OR MR. BALWANI AND YOU WERE TOLD, NO, YOU CAN'T HAVE THEM? HAVE YOU SEEN A SINGLE EMAIL, SIR?

1215

ADAM ROSENDORFF: ON -- IT WASN'T MY PLACE TO BE DIRECTING THE COMPANY REGARDING ALLOCATION OF RESOURCES.

1216

MR. WADE: SIR, YOU WERE RESPONSIBLE TO ENSURE THAT AAP WAS DONE WITHIN THE COMPANY; CORRECT?

1218

MR. WADE: OKAY. AND YOUR COMPLAINT WAS THAT THERE WASN'T ENOUGH RESOURCES DEDICATED TO IT; RIGHT?

1220

MR. WADE: AND YOU SENT A LOT OF EMAILS WHILE AT THERANOS; CORRECT?

1222

MR. WADE: AND WAS THERE EVER A SINGLE EMAIL THAT YOU'VE SEEN WHERE YOU ASKED FOR THAT AND YOU WERE DENIED RESOURCES FOR AAP, A SINGLE EMAIL?

1223

ADAM ROSENDORFF: I DON'T RECALL.

1224

MR. WADE: YEAH. DO YOU RECALL IN THE FALL OF 2014 THERE WERE SOME ACTIONS ON YOUR PART THAT WERE SOMEWHAT ERRATIC OR UNCHARACTERISTIC. DO YOU RECALL THAT?

1225

ADAM ROSENDORFF: COULD YOU CLARIFY?

1226

MR. WADE: SURE. DO YOU RECALL THERE WAS AN OCCASION WHERE YOU FAILED TO RETURN THE CALL OF A DOCTOR FOR A WEEK? DO YOU RECALL THAT?

1227

ADAM ROSENDORFF: I SPOKE TO THE DOCTOR ONCE. I WAS RELUCTANT TO JUSTIFY DISCREPANT RESULTS TO THE DOCTOR ON A SUBSEQUENT PHONE CALL. I COMMUNICATED THAT TO THE COMPANY.

1228

MR. WADE: WE'LL TALK ABOUT THAT ISSUE WHICH I BELIEVE WAS NOVEMBER 20TH OR 21ST. BUT THERE WAS ACTUALLY AN EMAIL THAT YOU WERE SENT ON OCTOBER 10TH WHERE YOU WERE ASKED TO CALL THE DOCTOR, YOU SAID YOU WERE, YOU WOULD, AND YOU DIDN'T RETURN THE CALL FOR A WEEK AND THEY HAD TO FOLLOW UP AGAIN. DO YOU RECALL THAT?

1230

MR. WADE: AND I BELIEVE YOU SAID IT WAS A MISTAKE?

1231

ADAM ROSENDORFF: I WAS REALLY SWAMPED WITH DEALING WITH ISSUES AND PROBLEMS AT THE COMPANY. THAT MAY HAVE SKIPPED MY ATTENTION.

1232

MR. WADE: THAT'S WHAT YOU WERE SWAMPED WITH ON OCTOBER 10TH?

1233

ADAM ROSENDORFF: I BELIEVE SO.

1234

MR. WADE: OKAY. THAT WAS THE SAME DAY THAT YOU CANCELLED THE MEETING THAT YOU REQUESTED WITH SENIOR LEADERSHIP TO DISCUSS AAP? DO YOU RECALL THAT, OCTOBER 10TH?

1235

ADAM ROSENDORFF: NO. SUNNY ASKED ME IF A FOLLOW-UP MEETING WAS NEEDED AND I SAID NO.

1236

MR. WADE: NO. BUT DO YOU RECALL THERE WAS A MEETING SET FOR OCTOBER 10TH -- HERE, LET'S PULL IT UP. EXHIBIT 13923. IT'S IN EVIDENCE. LET'S GO TO THE SECOND PAGE. IT WAS INITIALLY SET FOR THE 10TH, AND THEN IT WAS MOVED PER ADAM'S REQUEST?

1237

ADAM ROSENDORFF: YES, I SEE THAT.

1238

MR. WADE: DO YOU SEE THAT?

1240

MR. WADE: AND SO THERE WAS INITIALLY -- SO YOU WERE ASKED TO CALL THE DOCTOR ON THE 10TH AND YOU DIDN'T CALL THE DOCTOR; RIGHT? AND THEN YOU ASKED TO SCHEDULE A MEETING -- IT WAS SCHEDULED WITH THE SENIOR LEADERSHIP THE NEXT DAY ON OCTOBER 10TH, AND YOU ASKED TO MOVE IT FIVE DAYS; CORRECT?

1242

MR. WADE: OKAY. AND THE REASON THAT YOU DID THAT, SIR, IS BECAUSE YOU WERE INTERVIEWING FOR ANOTHER JOB THAT DAY; RIGHT?

1243

ADAM ROSENDORFF: I DON'T RECALL.

1244

MR. WADE: WELL, LET'S LOOK AT THE DOCUMENT. LET'S GO TO 13756. IF YOU CAN REVIEW THE EMAILS DOWN AT THE BOTTOM OF THE PAGE AND LET ME KNOW WHEN YOU'VE HAD A CHANCE TO REVIEW THAT.

1245

ADAM ROSENDORFF: ARE YOU TALKING ABOUT THE SECOND PAGE OR ARE YOU --

1246

MR. WADE: YOU CAN REVIEW THE FIRST PAGE, AND I CALL YOUR ATTENTION IN PARTICULAR TO THE BOTTOM OF THE PAGE.

1248

MR. WADE: AND DO YOU RECALL THESE EMAILS BETWEEN YOU AND PEOPLE AT INVITAE?

1250

MR. WADE: AND A HEAD HUNTER?

1252

MR. WADE: OKAY. MOVE THE ADMISSION OF 13756.

1253

MR. BOSTIC: NO OBJECTION.

1254

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

1255

(DEFENDANT'S EXHIBIT 13756 WAS RECEIVED IN EVIDENCE.)

1256

MR. WADE: DO YOU SEE WHERE IT TALKS ABOUT CONFIRMING A MEETING IN SAN FRANCISCO FROM 12:00 TO 5:00 ON OCTOBER 10? DO YOU SEE THAT?

1258

MR. WADE: DO YOU SEE THAT? AND, IN FACT, YOU WENT TO SAN FRANCISCO ON OCTOBER 10TH AND YOU SPENT THE AFTERNOON INTERVIEWING WITH EXECUTIVES AT INVITAE; CORRECT?

1259

ADAM ROSENDORFF: I DO NOT RECALL THE EXACT DAY THAT I WENT THERE. I DON'T RECALL THAT INDEPENDENTLY FROM READING THIS.

1260

MR. WADE: OKAY. WE'LL COME BACK TO THAT. DO YOU RECALL THAT YOU STARTED APPLYING FOR THIS POSITION IN AUGUST?

1261

ADAM ROSENDORFF: I DON'T RECALL.

1262

MR. WADE: DO YOU RECALL THAT YOU WERE CONTACTED BY THAT HEADHUNTER VIA LINKEDIN IN LATE AUGUST 2014?

1263

ADAM ROSENDORFF: I DON'T RECALL.

1264

MR. WADE: LET'S LOOK AT EXHIBIT 13751. DO YOU HAVE THAT IN FRONT OF YOU?

1266

MR. WADE: DOES THAT REFRESH YOUR RECOLLECTION THAT YOU ACCEPTED A LINKEDIN INVITATION FROM THAT HEADHUNTER IN AUGUST OF 2014?

1269

ADAM ROSENDORFF: I'M SORRY, CORRECTION. I'M READING IT HERE. I DON'T HAVE AN INDEPENDENT RECOLLECTION.

1270

MR. WADE: OKAY. LET'S GO TO EXHIBIT 13753. DO YOU HAVE THAT DOCUMENT IN FRONT OF YOU?

1272

MR. WADE: AND THAT'S AN EMAIL FROM YOU TO THE HEADHUNTER WITH A COPY OF YOUR RESUME?

1274

MR. WADE: MOVE THE ADMISSION OF 13753.

1275

MR. BOSTIC: NO OBJECTION.

1276

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

1277

(DEFENDANT'S EXHIBIT 13753 WAS RECEIVED IN EVIDENCE.)

1278

BY MR. WADE:

1279

MR. WADE: AND HERE YOU'RE SENDING A COPY OF YOUR RESUME TO MOLLY RYAN AT DOUBLE-HELIX; CORRECT?

1281

MR. WADE: AND THAT WAS IN PURSUIT OF THAT INVITAE POSITION?

1283

MR. WADE: OKAY. AND LET'S GO TO 13754. DO YOU HAVE THAT IN FRONT OF YOU?

1285

MR. WADE: THAT'S YOUR RESUME DURING THIS TIME PERIOD; CORRECT?

1287

MR. WADE: MOVE THE ADMISSION OF 13754.

1288

MR. BOSTIC: NO OBJECTION.

1289

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

1290

(DEFENDANT'S EXHIBIT 13754 WAS RECEIVED IN EVIDENCE.)

1291

BY MR. WADE:

1292

MR. WADE: LET'S BLOW UP THE SECTION RELATING TO THERANOS. IS THIS A TRUE, ACCURATE, AND COMPLETE DESCRIPTION OF YOUR WORK AT THERANOS?

1293

ADAM ROSENDORFF: IT'S A SELECTION OF THE THINGS THAT I WAS WORKING ON AT THERANOS.

1294

MR. WADE: IS IT TRUTHFUL AND ACCURATE?

1295

ADAM ROSENDORFF: I BELIEVE SO. I'M SORRY, I WAS NOT INVOLVED IN NEW YORK STATE INSPECTIONS.

1296

MR. WADE: SO IT'S INACCURATE?

1297

ADAM ROSENDORFF: THE NEW YORK STATE IS NOT ACCURATE, CORRECT.

1298

MR. WADE: OKAY. IS IT OTHERWISE ACCURATE?

1300

MR. WADE: AND IT TALKS ABOUT MUCH OF THE GOOD WORK YOU WERE DOING THERE. DO YOU SEE THAT?

1301

ADAM ROSENDORFF: SO I DON'T KNOW IF YOU'VE EVER TRIED TO APPLY FOR A JOB, BUT IT GENERALLY DOESN'T SERVE YOU IF YOU TALK ABOUT A COMPANY THAT HAS BEEN ACCUSED OF FRAUDULENT PRACTICES OR IS UNDER INVESTIGATION.

1302

MR. WADE: OKAY. MOVE TO STRIKE THAT ANSWER, YOUR HONOR.

1303

JUDGE DAVILA: OVERRULED.

1304

BY MR. WADE:

1305

MR. WADE: DO YOU SEE WHERE IT TALKS ABOUT SOME OF THE WORK THAT YOU PERFORMED --

1307

MR. WADE: -- AS A LABORATORY DIRECTOR AT THERANOS?

1309

MR. WADE: OKAY. AND DO YOU SEE WHERE IT TALKS ABOUT HOW YOU WORKED EXTENSIVELY WITH R&D LEADS AND DIRECTED LABORATORY STAFF? DO YOU SEE THAT?

1311

MR. WADE: AND DO YOU SEE HOW IT SAYS YOU ESTABLISHED THE TECHNICAL PERFORMANCE OF OVER 70 NOVEL ASSAY METHODS?

1313

MR. WADE: AND YOU BELIEVED THAT AT THE TIME; CORRECT?

1315

MR. WADE: OKAY. AND DO YOU SEE WHERE IT SAYS THAT YOU SUCCESSFULLY LED LABORATORY THROUGH STATE AND FEDERAL INSPECTIONS? DO YOU SEE THAT?

1317

MR. WADE: AND WITH THE EXCEPTION OF NEW YORK, YOU BELIEVE THAT TO BE TRUE; CORRECT?

1319

MR. WADE: AND DO YOU SEE WHERE IT SAYS THAT YOU'VE PROVIDED REGULATORY GUIDANCE ON CLIA AND STATE LABORATORY COMPLIANCE?

1321

MR. WADE: DO YOU SEE THAT?

1323

MR. WADE: AND YOU BELIEVED THAT TO BE TRUE?

1325

MR. WADE: OKAY. AND YOU CONDUCTED AN INTERVIEW IN SEPTEMBER WITH A GENTLEMAN BY THE NAME OF SWAROOP ARADHYA?

1327

MR. WADE: ARADHYA. HE WORKED AT INVITAE?

1329

MR. WADE: AND IT WAS AFTER -- THAT WAS IN SEPTEMBER OF 2014?

1330

ADAM ROSENDORFF: I REMEMBER MEETING WITH HIM AT A CAFE IN PALO ALTO.

1331

MR. WADE: DURING THE WORK DAY; RIGHT?

1334

ADAM ROSENDORFF: I DON'T REMEMBER THE DATE.

1335

MR. WADE: OKAY. AND THEN YOU LATER SPENT OCTOBER 10TH WITH THE EXECUTIVE TEAM AS SET FORTH IN THAT EMAIL; RIGHT?

1336

ADAM ROSENDORFF: AGAIN, I DON'T REMEMBER THE DATE.

1337

MR. WADE: OKAY. BUT IT WAS UP IN SAN FRANCISCO. YOU RECALL THAT?

1339

MR. WADE: AND IT WAS IN THE AFTERNOON FROM 12:00 TO 5:00?

1341

MR. WADE: AND DO YOU HAVE ANY REASON TO QUESTION THAT IT WAS ON OCTOBER 10TH AS SET FORTH IN THAT EMAIL?

1342

ADAM ROSENDORFF: I HAVE -- I DO NOT RECALL WHEN IT WAS.

1343

MR. WADE: OKAY. DO YOU RECALL THAT YOU WERE -- WITH RESPECT TO SOME OF YOUR ACTS AT THE COMPANY, YOU ALSO ASKED THE COMPANY TO SEND A COMPANY-WIDE EMAIL IN RESPONSE TO A RUMOR ABOUT EBOLA TESTING?

1345

MR. WADE: AND THERE WAS A RUMOR GOING AROUND AND YOU WERE DEMANDING THAT A COMPANY-WIDE RUMOR -- THAT A COMPANY-WIDE EMAIL BE SENT TO QUASH THAT RUMOR?

1346

ADAM ROSENDORFF: I HAD BEEN INFORMED BY MEMBERS OF THE CLIA TEAM THAT THE LABORATORY WAS PLANNING OR IN THE PROCESS OF VALIDATING A TEST FOR EBOLA. I HAD NOT BEEN INFORMED OF THIS.

1347

MR. WADE: YOU ASKED AND SENIOR LEADERSHIP TOLD YOU THAT'S NOT TRUE; RIGHT?

1348

ADAM ROSENDORFF: ELIZABETH TOLD ME THAT WAS NOT TRUE.

1349

MR. WADE: BUT YOU STILL WANT THEM TO SEND A COMPANY-WIDE EMAIL; CORRECT?

1351

MR. WADE: AND YOU THEN RECEIVED -- AFTER THOSE EVENTS OF THE FALL THAT WE JUST DISCUSSED, YOU RECEIVED AN OFFER TO JOIN INVITAE AS LAB DIRECTOR ON NOVEMBER 12TH, 2014; RIGHT?

1352

ADAM ROSENDORFF: I DON'T RECALL THE DATE.

1353

MR. WADE: OKAY. LET'S LOOK AT EXHIBIT 12913.

1355

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

1357

MR. WADE: OKAY. AND DOES THAT REFRESH YOUR RECOLLECTION -- IS THIS YOUR OFFER LETTER FROM INVITAE?

1358

ADAM ROSENDORFF: IT APPEARS TO BE, YES.

1359

MR. WADE: OKAY. IF YOU LOOK AT THE THIRD PAGE, IS THAT YOUR SIGNATURE THERE?

1361

MR. WADE: MOVE THE ADMISSION OF 12913.

1362

MR. BOSTIC: NO OBJECTION.

1363

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

1364

(DEFENDANT'S EXHIBIT 12913 WAS RECEIVED IN EVIDENCE.)

1365

BY MR. WADE:

1366

MR. WADE: OKAY. SO YOU WERE OFFERED AT SOME POINT ON OR ABOUT NOVEMBER 12TH, 2014 A JOB AT INVITAE?

1368

MR. WADE: AND YOU ACCEPTED IT ON NOVEMBER 12TH, 2014?

1370

MR. WADE: AND THEY WANTED YOU TO START SOON; RIGHT?

1372

MR. WADE: AND YOU WERE OFFERED MORE MONEY TO GO THERE; RIGHT?

1373

ADAM ROSENDORFF: NOT A LOT MORE. I ALSO WANT TO POINT OUT THAT ELIZABETH GAVE ME STOCK OPTIONS. IN VIEW OF THE RISKS AND MY CONCERNS WITH THERANOS, I WALKED AWAY FROM THOSE STOCK OPTIONS AT THERANOS. I DIDN'T THINK IT WAS WORTH IT TO STAY AT THE COMPANY FOR THE ISSUES THAT WE HAVE BEEN DISCUSSING IN THIS TRIAL.

1374

MR. WADE: ALL RIGHT, SIR. I UNDERSTAND THAT. BUT MY QUESTION TO YOU WAS THAT YOU WERE GOING TO BE PAID MORE MONEY?

1375

ADAM ROSENDORFF: $15,000 MORE.

1376

MR. WADE: HOW MUCH?

1377

ADAM ROSENDORFF: $15,000 MORE.

1378

MR. WADE: OKAY. YOU WERE GOING TO BE PAID $260,000 A YEAR?

1380

MR. WADE: AND DO YOU KNOW HOW MUCH YOU WERE MAKING AT THIS TIME AT THERANOS?

1381

ADAM ROSENDORFF: I HAVE -- I'VE REVIEWED MY OFFER LETTER RECENTLY FROM THERANOS, AND ALSO WE HAVE DISCUSSED IT DURING THIS TRIAL, AND I BELIEVE I WAS BEING PAID 240,000 A YEAR.

1382

MR. WADE: OKAY. SO YOU WERE OFFERED MORE MONEY; CORRECT?

1383

ADAM ROSENDORFF: NOT A LOT MORE.

1384

MR. WADE: OKAY. BUT YOU WERE OFFERED --

1385

ADAM ROSENDORFF: I DON'T KNOW WHAT WE'RE DISCUSSING HERE.

1386

MR. WADE: YOU WERE OFFERED 75,000 STOCK OPTIONS; CORRECT?

1387

ADAM ROSENDORFF: CORRECT. SO THAT WAS ACTUALLY DIVIDED BY FIVE AND THOSE STOCK OPTIONS WERE FOR A LONG PERIOD. THEY WERE NEVER IN THE MONEY. I BELIEVE I MADE JUST A FEW THOUSAND DOLLARS OFF OF THOSE STOCK OPTIONS AT INVITAE.

1388

MR. WADE: MOVE TO STRIKE EVERYTHING AFTER "CORRECT."

1389

JUDGE DAVILA: THE LAST PORTION WILL BE STRICKEN AFTER "CORRECT."

1390

BY MR. WADE:

1391

MR. WADE: IF I CALL YOUR ATTENTION TO PAGE 3, YOU WERE ACTUALLY OFFERED 75,000 OPTIONS THAT WERE GOING TO VEST OVER FOUR YEARS; CORRECT?

1393

MR. WADE: OKAY. AND INVITAE WAS ABOUT TO GO PUBLIC EARLY THE NEXT YEAR; RIGHT?

1395

MR. WADE: AND YOU WANTED TO BE A PART OF THAT; CORRECT?

1396

ADAM ROSENDORFF: CAN YOU CLARIFY? CAN YOU CLARIFY THE QUESTION?

1397

MR. WADE: YEAH. YOU WANTED, YOU WANTED TO HAVE -- YOU WANTED YOUR INTEREST TO BE ALIGNED WITH THE SUCCESS OF THE COMPANY GOING IN; RIGHT?

1398

ADAM ROSENDORFF: I WANTED TO JOIN A REPUTABLE COMPANY WHOSE MISSION I BELIEVED IN.

1399

MR. WADE: RIGHT. I UNDERSTAND. AND YOU WERE BEING GIVEN 75,000 OPTIONS IN A COMPANY WHO WAS ABOUT TO GO PUBLIC AS PART OF THAT?

1400

ADAM ROSENDORFF: YEAH, BUT I HAD NO IDEA WHAT THE VALUE OF THOSE OPTIONS WERE.

1401

MR. WADE: OKAY. AND IN ADDITION TO THAT, WHEN YOU WERE AT INVITAE, YOU HAD THE ABILITY TO ALSO WORK AS A PART-TIME LAB DIRECTOR; RIGHT?

1403

MR. WADE: AND THAT WAS ADDITIONAL MONEY THAT YOU COULD GET ON THE SIDE; RIGHT?

1405

MR. WADE: AND YOU DID THAT; RIGHT?

1407

MR. WADE: AND YOU MADE A LOT OF MONEY DOING THAT?

1409

MR. WADE: HOW MUCH DID YOU MAKE AS A PART-TIME LAB DIRECTOR?

1410

ADAM ROSENDORFF: I DON'T REMEMBER FOR SURE. I THINK IT WAS AROUND $2,000 PER MONTH.

1411

MR. WADE: WAS IT AROUND $4,500 A MONTH?

1412

ADAM ROSENDORFF: IT MAY HAVE BEEN. I DON'T RECALL.

1413

MR. WADE: AND HOW MANY POSITIONS DID YOU HAVE?

1414

ADAM ROSENDORFF: I ALSO WAS WORKING FOR PRECISION TOXICOLOGY AT THE TIME AS A PART-TIME LAB DIRECTOR, SO IT WOULD HAVE BEEN THREE.

1415

MR. WADE: WHEN YOU SAY AT THE TIME, YOU STARTED THAT WHEN?

1417

MR. WADE: YES. AT THE BEGINNING OF 2015?

1418

ADAM ROSENDORFF: I THINK IT WAS AROUND THE SAME TIME I STARTED AT INVITAE, YES.

1419

MR. WADE: AND I'M SORRY, WITH PRECISION, DO YOU KNOW HOW MUCH MONEY YOU WERE GOING TO MAKE?

1420

ADAM ROSENDORFF: I DON'T REMEMBER.

1421

MR. WADE: OKAY. AND SO YOU ACCEPTED THIS OFFER THE VERY SAME DAY; CORRECT? THAT LETTER IS DATED NOVEMBER 12TH AND YOU SIGNED IT NOVEMBER 12TH?

1423

MR. WADE: YOU WROTE THERE THAT THEY -- THAT THE START DATE WAS GOING TO BE NO LATER THAN JANUARY 12TH, 2015; CORRECT?

1425

MR. WADE: THEY WANTED YOU TO START QUICKLY, BUT YOU HAD A 60-DAY NOTICE PERIOD; RIGHT?

1426

ADAM ROSENDORFF: I BELIEVE I SENT AN EMAIL TO SUNNY AND ELIZABETH THE SAME DAY, NOVEMBER 12TH, INFORMING THEM THAT I FOUND OTHER EMPLOYMENT AND GIVING THEM A GOOD AMOUNT OF TIME TO FIND A REPLACEMENT LAB DIRECTOR.

1427

MR. WADE: RIGHT. IF YOU GO TO 12916.

1428

ADAM ROSENDORFF: I'M THERE. I'M THERE.

1429

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

1431

MR. WADE: AND IS THIS THE EMAIL THAT YOU WERE JUST REFERRING TO?

1433

MR. WADE: OKAY. I MOVE 12916.

1434

MR. BOSTIC: NO OBJECTION.

1435

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

1436

(DEFENDANT'S EXHIBIT 12916 WAS RECEIVED IN EVIDENCE.)

1437

MR. WADE: IF WE BLOW UP THE BOTTOM.

1438

MR. WADE: DO YOU SEE THERE IT SAYS -- THIS IS 7:52 ON NOVEMBER 12TH; CORRECT?

1440

MR. WADE: AND THAT'S THE VERY EVENING THAT YOU SIGNED THE OFFER LETTER; CORRECT?

1442

MR. WADE: AND WHEN YOU SAID NO LATER THAN JANUARY 12TH, THAT WAS BECAUSE YOU NEEDED TO GIVE TWO MONTHS NOTICE UNDER YOUR CONTRACT?

1444

MR. WADE: OKAY. AND YOU RESIGNED. YOU SAID YOU APPRECIATED THE OPPORTUNITY AND THE ABILITY TO INTERACT WITH SO MANY TALENTED AND DEDICATED INDIVIDUALS OVER THE LAST YEAR AND A HALF; CORRECT?

1446

MR. WADE: AND YOU SAID IT'S BEEN A TREMENDOUS EXPERIENCE; CORRECT?

1448

MR. WADE: AND THEN YOU GAVE THE NOTICE -- THE 60-DAY NOTICE; CORRECT?

1450

MR. WADE: AND MR. BALWANI, WHO IS YOUR DIRECT REPORT, RESPONDED; CORRECT?

1452

MR. WADE: OKAY. AND HE SAID -- HE THANKED YOU FOR THE COMMITMENT AND SAID HE APPRECIATED IT AND THAT HE WOULD SWING BY AND DISCUSS THIS WITH YOU; CORRECT?

1454

MR. WADE: OKAY. AND THIS IS ON NOVEMBER 13TH?

1456

MR. WADE: OKAY. AND IT WAS NOVEMBER 14TH WHERE YOU SEND THE EMAIL DEMANDING THE EBOLA RETRACTION; CORRECT?

1457

ADAM ROSENDORFF: I DON'T RECALL THE DATE ON THE EBOLA EMAIL. I'M SORRY.

1458

MR. WADE: OKAY. AND IT'S EXHIBIT 4330. I BELIEVE IT'S IN EVIDENCE. WE HAVE IT ON THE SCREEN. IF WE CAN GO TO THE LAST PAGE.

1459

ADAM ROSENDORFF: YES, I HAVE IT.

1460

MR. WADE: RIGHT. DO YOU SEE THAT? THE LAST PAGE, DO YOU SEE THAT YOU HAD SENT AN EMAIL LATE THE NIGHT WEDNESDAY, NOVEMBER 12TH RESIGNING; CORRECT?

1462

MR. WADE: AND THEN THIS IS NOVEMBER 14TH, 2014?

1464

MR. WADE: AND YOU'RE DIRECTING THE EMAIL TO THE TWO SENIOR EXECUTIVES IN THE COMPANY?

1466

MR. WADE: ABOUT A RUMOR ABOUT EBOLA; RIGHT? AND THAT RUMOR WAS DENIED; CORRECT?

1467

ADAM ROSENDORFF: ELIZABETH DENIED IT.

1468

MR. WADE: RIGHT. AND YOU ASKED FOR A COMPANY-WIDE EMAIL; RIGHT?

1470

MR. WADE: AND SHE RESPONDED THAT NO ONE ELSE REALLY HAD THAT IMPRESSION. CAN YOU SEE THAT?

1472

MR. WADE: AND DIDN'T SEEM INCLINED TO SEND THE EMAIL?

1473

ADAM ROSENDORFF: SHE'S ACKNOWLEDGING THAT FOLKS AT THE SITE ARE UNDER THIS IMPRESSION.

1474

MR. WADE: BUT SHE'S NOT AGREEING TO SEND THE EMAIL TO QUASH THE RUMOR; RIGHT?

1476

MR. WADE: AND THEN YOU RESPOND THAT DAY, "I FEEL REALLY UNCOMFORTABLE WITH WHAT IS HAPPENING RIGHT NOW IN THIS COMPANY." DO YOU SEE THAT?

1478

MR. WADE: AND YOU ASKED TO BE OFF THE CLIA LICENSE; RIGHT?

1480

MR. WADE: AND YOU WANTED TO BE OFF OF THE CLIA LICENSE SO YOU COULD GO AND START YOUR OTHER JOB; RIGHT?

1482

MR. WADE: YOU WERE ESCALATING ISSUES WITHIN THIS COMPANY IN THIS TIME PERIOD BECAUSE YOU'RE TRYING TO GET THEM TO RELEASE YOU FROM YOUR 60-DAY PERIOD; CORRECT?

1484

MR. WADE: OKAY. IN THIS SAME TIME PERIOD --

1485

ADAM ROSENDORFF: THE EBOLA WAS THE FINAL -- I MEAN, IT WAS ONE OF THE FINAL STRAWS FOR ME.

1486

MR. WADE: THAT RUMOR REALLY GOT TO YOU, SIR?

1487

ADAM ROSENDORFF: NO. MULTIPLE FOLKS TOLD ME ABOUT THIS.

1489

ADAM ROSENDORFF: I DIDN'T BELIEVE IT TO BE A RUMOR.

1490

MR. WADE: WELL, THAT WAS A FINAL STRAW?

1491

ADAM ROSENDORFF: ONE OF THEM.

1492

MR. WADE: YOU'VE NEVER TESTIFIED THAT THAT WAS A FINAL STRAW IN ANY OF YOUR PRIOR TESTIMONY? YOU'VE NEVER IDENTIFIED IT AS THE FINAL STRAW, BUT NOW IT'S YOUR TESTIMONY THAT IT WAS THE FINAL STRAW?

1493

ADAM ROSENDORFF: WELL, I WASN'T ASKED ABOUT -- I'VE NEVER BEEN ASKED ABOUT THIS EBOLA ISSUE OR WHAT THE FINAL DISSATISFACTION WAS AT THERANOS. THERE WERE MANY.

1494

MR. WADE: OKAY. AT THE SAME TIME YOU RAISED THAT ISSUE, THE SAME DAY, YOU RAISED AN ISSUE -- IF WE CAN BRING UP 4314, IF WE GO TO THE SECOND PAGE -- LET'S GO TO THE THIRD PAGE JUST SO WE HAVE THE CONTEXT. THAT SAME DAY, NOVEMBER 14TH, AFTER YOU SENT THE EBOLA EMAIL, YOU THEN WERE ASKED TO CALL A DOCTOR; RIGHT?

1496

MR. WADE: AND YOU REFUSED TO CALL THE DOCTOR; RIGHT?

1497

ADAM ROSENDORFF: NO. I SAID I WILL HAPPILY SPEAK TO A CLINICIAN, BUT I WILL NOT DEFEND THE RESULTS.

1498

MR. WADE: IF I CAN FOCUS YOU ON THE EMAIL ON PAGE 3. OKAY. DO YOU SEE YOU'RE ASKED TO CALL THE DOCTOR? DO YOU SEE THAT? IN MR. HOLMES'S EMAIL AT 12:54 P.M. YOU'RE ASKED TO CALL THE DOCTOR. DO YOU SEE THAT ONE?

1500

MR. WADE: AND YOU SAY, I'M GOING TO PASS ON THIS ONE?

1501

ADAM ROSENDORFF: WELL, MR. HOLMES WAS TRYING TO COME UP WITH A SCRIPT FOR ME IN MESSAGING AND I WAS RELUCTANT TO FOLLOW THAT SCRIPT.

1502

MR. WADE: AND MR. HOLMES WASN'T GOING TO GO ON THAT CALL; RIGHT?

1504

MR. WADE: YOU WERE GOING TO CALL THE DOCTOR?

1505

ADAM ROSENDORFF: THAT WAS THE EXPECTATION.

1506

MR. WADE: RIGHT. AND YOU HAVE YOUR OWN ABILITY TO EXERCISE YOUR OWN PROFESSIONAL JUDGMENT ON WHAT YOU'RE GOING TO SAY TO THAT DOCTOR; RIGHT?

1508

MR. WADE: OKAY. BUT YOU DIDN'T PICK UP THE PHONE AND SAY WHATEVER YOU THOUGHT WAS APPROPRIATE, YOU SAID YOU'RE GOING TO PASS ON THIS ONE; RIGHT?

1510

MR. WADE: OKAY. LET'S GO UP THE CHAIN. AND YOU'RE ASKED WHAT THIS MEANS. AND IF WE GO UP AGAIN. AND HE SAYS, "IF YOU'RE ASKING ME TO DEFEND THESE VALUES THEN THE ANSWER IS NO." RIGHT?

1511

ADAM ROSENDORFF: THAT WAS MY CLARIFICATION.

1512

MR. WADE: THAT WAS YOUR CLARIFICATION. AND IF YOU GO UP THE CHAIN AGAIN, HE'S TELLING YOU THAT HE'S NOT ASKING YOU TO DO THAT. HE'S JUST ASKING YOU TO CALL THE DOCTOR BACK; RIGHT?

1513

ADAM ROSENDORFF: NO, HE'S NOT ADDRESSING THE EXPECTED MESSAGING IN HIS EMAIL.

1514

MR. WADE: OKAY. WELL, HE'S ASKING YOU TO CALL THE DOCTOR; RIGHT?

1516

MR. WADE: OKAY. AND JUST SO WE'RE ALL CLEAR, THIS IS THE FIRST INSTANCE, THIS TEST RIGHT HERE IS THE FIRST INSTANCE OF AN OBVIOUSLY INCORRECT VALUE BEING REPORTED TO A PATIENT DURING YOUR TENURE AT THERANOS; CORRECT?

1518

MR. WADE: OKAY. DO YOU RECALL GIVING TESTIMONY PREVIOUSLY WITH RESPECT TO THIS EMAIL?

1520

MR. WADE: OKAY. AND THAT WAS IN THAT DEPOSITION IN ARIZONA; CORRECT?

1521

ADAM ROSENDORFF: I BELIEVE SO.

1522

MR. WADE: AND DO YOU RECALL TESTIFYING THAT THIS WAS THE FIRST INSTANCE OF AN OBVIOUSLY INCORRECT VALUE BEING REPORTED TO THE PATIENT?

1523

ADAM ROSENDORFF: I DON'T RECALL.

1524

MR. WADE: OKAY. LET'S LOOK AT THAT TESTIMONY. GO TO 171. IT'S THAT SAME ARIZONA EXHIBIT 11000.

1526

MR. WADE: IT'S IN THE YELLOW BINDER.

1527

ADAM ROSENDORFF: WHAT VOLUME?

1528

MR. WADE: VOLUME 1.

1530

MR. WADE: OKAY. IF YOU LOOK AT PAGE 168.

1532

MR. WADE: YOU'RE WELCOME TO READ PAGE 168 WHICH INTRODUCES THAT DOCUMENT, BUT I'M FOCUSSED ON THE QUESTION AND ANSWER ON PAGE 171.

1533

ADAM ROSENDORFF: OKAY, I'VE READ PAGE 168.

1534

MR. WADE: READ THROUGH 171 AND LET ME KNOW WHEN YOU GET TO LINE 15 ON 171.

1535

(PAUSE IN PROCEEDINGS.)

1536

ADAM ROSENDORFF: YES, I READ IT.

1537

BY MR. WADE:

1538

MR. WADE: DO YOU SEE THAT? AND DRAWING YOUR ATTENTION TO LINE 3, YOU WERE ASKED, "HAD YOU BEEN ASKED TO DEFEND RESULTS IN THIS MANNER AT OTHER POINTS IN YOUR TIME AT THERANOS?"

1539

ADAM ROSENDORFF: THIS ISN'T -- I'M SORRY.

1540

MR. WADE: YOU WERE ASKED THAT QUESTION, CORRECT, SIR?

1542

MR. WADE: AND YOU GAVE THIS ANSWER, "NOT REALLY, NO. I MEAN, THIS IS THE FIRST INSTANCE OF AN OBVIOUSLY INCORRECT VALUE BEING REPORTED TO THE PATIENT." DO YOU SEE THAT?

1544

MR. WADE: AND THAT'S WHAT YOU ANSWERED IN THAT SWORN TESTIMONY; CORRECT?

1545

ADAM ROSENDORFF: THAT'S WHAT I'M READING HERE.

1546

MR. WADE: AND THEN YOU WERE ASKED, "DO YOU REMEMBER OTHER INSTANCES WHERE AN OBVIOUSLY INCORRECT VALUE WAS REPORTED TO THE PATIENT?" AND YOU SAID, "NO." CORRECT?

1548

MR. WADE: YOU WERE TRYING IN THIS EMAIL TO GET THEM TO TAKE YOU OFF THE LICENSE AND TO LET YOU GO START YOUR OTHER JOB, WERE YOU NOT?

1549

ADAM ROSENDORFF: NO. I WANTED TO BE OFF THE LICENSE BECAUSE I WAS UNCOMFORTABLE WITH THE LEGAL RESPONSIBILITY THAT I HELD AT THERANOS AT THAT TIME.

1550

MR. WADE: AND IT DIDN'T WORK IN NOVEMBER 14TH, DID IT? AND SO YOU RAISED AN ISSUE AGAIN IN NOVEMBER 21ST. LET'S GO TO THAT. THIS IS 228.

1551

ADAM ROSENDORFF: I'M SORRY, WHICH EXHIBIT IS IT?

1552

MR. WADE: IT'S EXHIBIT 228. I BELIEVE IT'S IN THE GOVERNMENT'S BINDER.

1554

MR. WADE: AND WE WERE JUST LOOKING AT THIS. WE WILL GO TO THE NEXT PAGE. SO A WEEK HAD GONE BY SINCE THAT LAST EMAIL, AND THIS IS THE EMAIL THAT YOU REPORT UP, WE'RE STILL VOIDING CRITICAL ISE RESULTS FOR THE REDRAW; CORRECT?

1556

MR. WADE: AND THAT WAS THE PLAN THAT YOU HAD PUT IN PLACE TWO WEEKS BEFORE THEN; CORRECT?

1557

ADAM ROSENDORFF: THE VOIDING OF THE CRITICAL POTASSIUMS HAD STARTED WAY BEFORE THAT.

1559

ADAM ROSENDORFF: IT WAS THE SODIUMS THAT WE WERE DISCUSSING.

1560

MR. WADE: YOU HAD DISCUSSED THE VOIDING OF THE ISE RESULTS JUST A COUPLE WEEKS AGO. DO YOU RECALL THAT?

1561

ADAM ROSENDORFF: OF THE SODIUM RESULTS.

1562

MR. WADE: RIGHT. AND DO YOU RECALL THAT MR. BALWANI AND MS. HOLMES WERE UNAWARE OF THAT AT THAT TIME? DO YOU RECALL THAT?

1563

ADAM ROSENDORFF: THEY WERE CLAIMING TO BE UNAWARE, YES. THEY WERE CLAIMING TO BE.

1564

MR. WADE: BUT IT WAS ENACTED UNDER YOUR PROTOCOL; RIGHT?

1565

JUDGE DAVILA: IS THIS IN EVIDENCE, 228?

1566

COURT CLERK: NO, AND IT'S NOT ON THE JURORS' DISPLAY.

1567

MR. WADE: I'M SORRY. IT'S NOT 228, IT'S 2228. I'M SORRY. AND IT IS IN EVIDENCE.

1568

JUDGE DAVILA: THANK YOU.

1569

BY MR. WADE:

1570

MR. WADE: DO YOU SEE THAT? AND THIS WAS THE PLAN YOU PUT IN PLACE AS THE CLIA LAB DIRECTOR; CORRECT?

1572

MR. WADE: THE HANDLING OF THESE RESULTS IN THIS MANNER WAS SOMETHING THAT YOU HAD PUT IN PLACE AS THE CLIA LAB DIRECTOR; CORRECT?

1574

MR. WADE: OKAY. AND LET'S GO TO THE NEXT EMAIL. AND MR. BALWANI RESPONDS TO YOU; RIGHT? DO YOU SEE THAT?

1576

MR. WADE: OKAY. AND HE SAYS HE HAS VERY HIGH CONFIDENCE IN ALL OF THE RESULTS. DO YOU SEE THAT?

1578

MR. WADE: AND YOU FORWARD HIS RESPONSE WHERE HE EXPLAINS HIS POSITION UP TO --

1579

ADAM ROSENDORFF: HIS RESPONSE IS NOT ACCURATE.

1580

MR. WADE: I UNDERSTAND YOUR VIEW, SIR. YOU SENT HIS RESPONSE UP TO MS. HOLMES; CORRECT?

1582

MR. WADE: AND YOU SAY YOU FIND IT DISINGENUOUS AND THAT HE SHOULD APOLOGIZE; CORRECT?

1584

MR. WADE: AND ON THE DAY YOU WERE SENDING THIS, YOU WERE NOT EVEN IN THE OFFICE, WERE YOU, SIR?

1585

ADAM ROSENDORFF: I BELIEVE I WAS IN THE NEWARK FACILITY. I DON'T RECALL EXACTLY WHERE I WAS.

1586

MR. WADE: YOU ARE AWARE THAT THEY HAVE BADGES AT THERANOS; CORRECT?

1588

MR. WADE: AND THEY'RE ABLE TO CHECK WHEN YOU GO IN AND OUT; RIGHT?

1589

ADAM ROSENDORFF: OH, THE DOOR WAS PROPPED OPEN NEXT TO MY OFFICE SO I WOULDN'T HAVE NEEDED TO BADGE IN.

1590

MR. WADE: OKAY. AND, IN FACT, AFTER THIS DAY --

1591

ADAM ROSENDORFF: I BELIEVE I WAS IN THE OFFICE ACTUALLY, YEAH.

1592

MR. WADE: AND AFTER THIS DAY, YOU DIDN'T GO INTO THE OFFICE AGAIN UNTIL DECEMBER; CORRECT?

1593

ADAM ROSENDORFF: I DON'T RECALL. I REMEMBER VISITING FAMILY FOR THANKSGIVING, AND THEN I REMEMBER ANOTHER VISIT AND IT WAS ESSENTIALLY MY LAST DAY, BUT THAT WAS AT THE PALO ALTO OFFICE.

1594

MR. WADE: RIGHT. YOU WERE CALLED IN SPECIFICALLY TO HAVE A MEETING WITH MR. BALWANI AND MONA RAMAMURTHY; CORRECT?

1596

MR. WADE: AND IN BETWEEN THIS DAY WHEN YOU SENT THIS EMAIL AND THAT DAY, YOU WEREN'T IN THE OFFICE; RIGHT?

1597

ADAM ROSENDORFF: I RECALL -- AS I SAID, I RECALL TAKING SOME TIME OFF AT THANKSGIVING, AND I INFORMED MANAGEMENT OF MY PLANS.

1599

ADAM ROSENDORFF: I DON'T REMEMBER THE EXACT DATES.

1600

MR. WADE: LET'S LOOK AT 5 -- I'D ASK TO DISPLAY 5387C, WHICH IS IN EVIDENCE.

1601

COURT CLERK: COUNSEL.

1602

MR. WADE: OH, IT ISN'T. MY APOLOGIES. I WOULD MOVE THE ADMISSION OF 5387C, WHICH IS A SUBSET OF THE TEXT MESSAGES THAT THE GOVERNMENT HAS BEEN DISPLAYING.

1603

MR. BOSTIC: HEARSAY, YOUR HONOR, ESPECIALLY WITHOUT KNOWING WHICH SUBSET WE ARE TALKING ABOUT.

1604

JUDGE DAVILA: MAYBE YOU SHOULD LAY A FOUNDATION.

1605

MR. WADE: WELL, THE FOUNDATION WAS LAID WITH THE OTHER WITNESS, YOUR HONOR. I CAN'T LAY A FOUNDATION WITH THIS WITNESS.

1606

JUDGE DAVILA: WELL, I'LL SUSTAIN AN OBJECTION. I'M NOT SURE WHAT YOU'RE GOING TO.

1608

MR. WADE: ARE YOU AWARE THAT IN THIS TIME PERIOD MR. BALWANI WAS MAKING REPEATED TRIPS OVER TO THE NEWARK FACILITY?

1609

ADAM ROSENDORFF: WHAT TIME PERIOD ARE YOU REFERENCING?

1610

MR. WADE: THE TIME PERIOD ESSENTIALLY IMMEDIATELY AFTER THIS EMAIL?

1611

ADAM ROSENDORFF: AFTER NOVEMBER 14TH?

1613

ADAM ROSENDORFF: NOVEMBER 21ST?

1615

ADAM ROSENDORFF: I SAW HIM MAYBE ONCE --

1617

ADAM ROSENDORFF: -- WHILE I WAS IN NEWARK, YEAH.

1618

MR. WADE: OKAY. DO YOU RECALL HIM HAVING TO COME OVER AND BRING NEW STAFF INTO NEW POSITIONS IN THIS EXACT TIME PERIOD AND START TO ADDRESS PROBLEMS WITHIN YOUR LAB?

1620

MR. WADE: BECAUSE YOU WEREN'T IN THE LAB, WERE YOU?

1621

ADAM ROSENDORFF: I DON'T RECALL.

1623

ADAM ROSENDORFF: ARE YOU SUGGESTING THAT MY ABSENCE SOMEWHAT SHOWS MY LACK OF COMMITMENT AS A LAB DIRECTOR?

1624

MR. WADE: I'M ASKING WHETHER YOU OBSERVED MR. BALWANI GO IN THERE TO CLEAN UP WHAT HE BELIEVED TO BE A DISASTER ZONE IN YOUR LAB. DO YOU RECALL THAT?

1625

ADAM ROSENDORFF: I DON'T RECALL.

1627

ADAM ROSENDORFF: THE NEWARK LAB HAD ONLY BEEN OPEN FOR MAYBE A FEW WEEKS AT THIS POINT.

1628

MR. WADE: OKAY. AND YOU TESTIFIED THAT IN YOUR MEETING WITH MR. BALWANI HE ASKED YOU TO STAY AT THE COMPANY; RIGHT?

1630

MR. WADE: OKAY. IN FACT, HE HAD PAPERWORK, HE HAD EXIT PAPERWORK AND CLIA TRANSITION DOCUMENTS THERE FOR YOU AT THAT MEETING; CORRECT?

1632

MR. WADE: AND HE TOOK YOU OFF THE LICENSE AT THAT MEETING; CORRECT?

1633

ADAM ROSENDORFF: HE DID NOT TAKE ME OFF THE ARIZONA LICENSE.

1635

ADAM ROSENDORFF: I HAD TO FOLLOW UP WITH LFS TO GET MYSELF OFF THE ARIZONA LICENSE.

1636

MR. WADE: AND THE POINT WAS, HE WANTED YOU OUT; RIGHT?

1637

ADAM ROSENDORFF: NO. HE WAS, HE WAS -- IT WAS CONCILIATORY. HE WANTED TO CHAT. AS I TESTIFIED, I REFUSED TO SHAKE HIS HAND. AT ONE POINT HE SAID THAT I COULD STAY ON IF I WANTED TO AND I SAID NO, IT WASN'T WORTH THE RISK TO MY REPUTATION. AND THEN THE WHOLE TONE OF THE CONVERSATION CHANGED.

1638

MR. WADE: SIR, HE HAD THE TERMINATION CERTIFICATE IN HIS HAND TO REMOVE YOU AS CLIA LAB DIRECTOR; CORRECT?

1639

ADAM ROSENDORFF: I DON'T RECALL.

1640

MR. WADE: OKAY. AND BY THE TIME YOU GOT THERE, SIR, THE COMPANY HAD DISCOVERED THAT YOU HAD STOLEN OVER 150 EMAILS THAT YOU HAD SENT TO YOURSELF; CORRECT?

1641

ADAM ROSENDORFF: I DID FORWARD MYSELF, CORRECT.

1642

MR. WADE: TO YOUR GMAIL ACCOUNT; CORRECT?

1644

MR. WADE: AND INCLUDING EXTENSIVE PATIENT HEALTH INFORMATION; CORRECT?

1645

ADAM ROSENDORFF: I DON'T RECALL.

1646

MR. WADE: YOU DON'T RECALL? IF YOU TAKE A LOOK AT 13926.

1647

ADAM ROSENDORFF: IN THE GOVERNMENT'S BINDER?

1648

MR. WADE: ACTUALLY -- I'M SORRY. LOOK AT 13927 IN THE DEFENSE BINDER.

1649

ADAM ROSENDORFF: THE VOLUME 2 ENDS AT 13923.

1650

MR. WADE: TAKE A LOOK AT THE BACK OF IT. I THINK YOU'LL FIND IT THERE. WE ADDED IT TO YOUR BINDER.

1652

MR. WADE: OKAY. DO YOU SEE, DO YOU SEE THIS IS AN EMAIL THAT YOU SENT TO YOURSELF IN OCTOBER OF 2014?

1654

MR. WADE: AND DO YOU SEE ATTACHED TO IT IS A SPREADSHEET?

1656

MR. WADE: AND DO YOU SEE THAT THAT SPREADSHEET CONTAINS EXTENSIVE PATIENT HEALTH INFORMATION?

1657

ADAM ROSENDORFF: IT CONTAINS PATIENT INFORMATION, YES.

1658

MR. WADE: IT CONTAINS TWO PAGES OF DETAILED HEALTH INFORMATION FOR MAYBE 100 PATIENTS?

1659

ADAM ROSENDORFF: I DELETED THESE EMAILS THE SAME DAY.

1660

MR. WADE: WE'LL GET TO THAT.

1661

ADAM ROSENDORFF: I SEE THAT IT HAS PATIENT INFORMATION, YES.

1662

MR. WADE: AND MANY OF THE OTHER EMAILS THAT YOU SENT HAD LAB -- HAD PATIENT LAB INFORMATION RELATING TO THEIR HEALTH; CORRECT?

1664

MR. WADE: AND YOU DIDN'T REDACT THEM WHEN YOU SENT THEM TO YOUR GMAIL ACCOUNT, DID YOU?

1666

MR. WADE: AND THAT'S A HIPAA VIOLATION, IS IT NOT?

1667

ADAM ROSENDORFF: I DON'T KNOW.

1668

MR. WADE: AND YOU WERE SENDING THIS INFORMATION TO USE IT FOR YOUR COMMERCIAL BENEFIT?

1669

ADAM ROSENDORFF: NO, NOT AT ALL.

1670

MR. WADE: YOU WERE SENDING IT SO YOU COULD TRY TO GET MONEY IN THAT LAWSUIT?

1671

ADAM ROSENDORFF: NO, NOT AT ALL.

1672

MR. WADE: OKAY. YOU ALSO STOLE SOME TRADE SECRET INFORMATION; RIGHT?

1673

ADAM ROSENDORFF: I DON'T BELIEVE, NO.

1674

MR. WADE: AND YOU STOLE INFORMATION THAT RELATED TO THE COMPANY'S VALIDATION OF CERTAIN METHODS; RIGHT?

1675

ADAM ROSENDORFF: I DON'T RECALL.

1676

MR. WADE: OKAY. YOU STOLE INFORMATION THAT DESCRIBED THEIR PRIMARY TESTING METHODS?

1677

ADAM ROSENDORFF: I DON'T RECALL.

1678

MR. WADE: OKAY. AND ARE YOU AWARE THAT THE COMPANY, WHEN THEY DISCOVERED THIS, HAD TO GO THROUGH SPECIAL PROCEDURES WITH SPECIAL COUNSEL TO MAKE -- TO DEAL WITH THE HIPAA ISSUES?

1679

ADAM ROSENDORFF: I WAS NOT AWARE.

1680

MR. WADE: THEY DIDN'T TELL YOU THAT?

1682

MR. WADE: OKAY. AND THEY WERE AWARE OF THIS ON THE DAY THAT YOU WALKED IN THE DOOR; RIGHT? YOU DISCUSSED THOSE EMAILS WITH MS. RAMAMURTHY; RIGHT?

1684

MR. WADE: BUT IT'S YOUR TESTIMONY THAT THEY OFFERED YOU TO COME BACK IN; RIGHT?

1685

ADAM ROSENDORFF: YES, WHEN I CHATTED WITH SUNNY IN THE BEGINNING, YES.

1686

MR. WADE: OKAY. AND THEY ASKED YOU IF YOU DELETED THE INFORMATION; RIGHT?

1688

MR. WADE: BECAUSE THEY WERE DEALING WITH AN IMPORTANT HIPAA VIOLATION HERE; CORRECT?

1689

ADAM ROSENDORFF: I CAN'T SPECULATE AS TO WHAT THEIR REASONS WERE FOR ME WANTING TO DELETE THE EMAILS.

1690

MR. WADE: WELL, THEY TOLD YOU THEY WERE VERY CONCERNED ABOUT THIS; RIGHT?

1691

ADAM ROSENDORFF: NO, THEY DIDN'T MENTION HIPAA AT THE TIME.

1692

MR. WADE: OKAY. THEY TOLD YOU THAT THEY WERE VERY CONCERNED THAT YOU HAD THIS INFORMATION; CORRECT?

1693

ADAM ROSENDORFF: CORRECT. THEY WERE VERY WORRIED.

1694

MR. WADE: AND THEY ASKED YOU IF YOU DELETED IT; RIGHT?

1695

ADAM ROSENDORFF: SO WHAT HAPPENED -- I CAN EXPLAIN. SO WHAT HAPPENED IS SUNNY VERY AGGRESSIVELY ORDERED ME TO SIT WITH MONA AND TO GO INTO MY GMAIL ACCOUNT AND DELETE THESE EMAILS WHILE STILL IN THE OFFICE.

1696

MR. WADE: HE WANTED YOU TO REMOVE THAT INFORMATION BECAUSE THEY WERE VERY CONCERNED ABOUT IT; RIGHT?

1697

ADAM ROSENDORFF: YES, THEY WERE.

1698

MR. WADE: AND YOU REFUSED TO DO THAT; RIGHT?

1699

ADAM ROSENDORFF: AT THAT MOMENT, YES.

1700

MR. WADE: RIGHT. AND WHEN YOU WENT BACK, THERE WAS FOLLOWUP ON THIS ISSUE, THIS IMPORTANT ISSUE; RIGHT?

1701

ADAM ROSENDORFF: WENT BACK WHERE?

1702

MR. WADE: WHEN YOU LEFT? YOU LEFT SHORTLY AFTER THIS; CORRECT?

1704

MR. WADE: AND YOU WOULDN'T SIGN A CERTIFICATE THAT YOU HAD COMPLIED WITH HIPAA AND OTHER COMPANY POLICIES AT THAT TIME; RIGHT?

1705

ADAM ROSENDORFF: I DON'T RECALL.

1706

MR. WADE: OKAY. AND YOU GOT A LAWYER; RIGHT?

1707

ADAM ROSENDORFF: I ALREADY HAD A LAWYER, RIGHT.

1708

MR. WADE: AND YOU REPRESENTED -- YOU ACTUALLY SENT AN EMAIL AFTER THAT TO MS. RAMAMURTHY IN WHICH YOU REPRESENTED THAT YOU DELETED ALL OF THE EMAILS; RIGHT?

1709

ADAM ROSENDORFF: I BELIEVE I DELETED THEM THE SAME EVENING. I WENT INTO THE APPLE STORE AND WENT INTO MY GMAIL ACCOUNT AND DELETED ALL OF THE EMAILS.

1710

MR. WADE: YOU HAD NOT DELETED ALL OF THE EMAILS AS OF THAT DATE, HAD YOU, SIR?

1711

ADAM ROSENDORFF: I DON'T RECALL.

1712

MR. WADE: YOU DON'T RECALL? YOU DON'T RECALL THAT IT CAME UP WHERE YOU LIED AGAIN AND AGAIN ABOUT HAVING DELETED THOSE EMAILS THROUGH YOUR LAWYER? YOU DON'T RECALL THAT COMING UP?

1714

MR. WADE: OKAY. YOUR HONOR, THIS MAY BE A GOOD TIME FOR COUNSEL TO APPROACH TO DISCUSS THE ISSUE THAT WE DISCUSSED THIS MORNING.

1715

JUDGE DAVILA: ARE YOU AT THE CONCLUSION OF YOUR EXAMINATION, SAVE FOR THOSE ISSUES?

1717

JUDGE DAVILA: ALL RIGHT. LADIES AND GENTLEMEN, LET ME ASK THE JURY TO -- WE'LL TAKE A BRIEF RECESS. I NEED TO TALK TO THESE LAWYERS ABOUT SOMETHING. SO WE'LL TAKE A RECESS. LADIES AND GENTLEMEN OF THE JURY, YOU CAN GO TO THE DELIBERATION ROOM AND WE'LL CALL YOU BACK. DR. ROSENDORFF, YOU MAY STEP DOWN.

Procedural 1Proc. 1Evidentiary Hearing on Rosendorff's Post-Theranos Employment
1718

(JURY OUT AT 12:55 P.M.)

1719

JUDGE DAVILA: PLEASE BE SEATED. THE RECORD SHOULD REFLECT THAT OUR JURY HAS LEFT THE COURTROOM. DR. ROSENDORFF HAS LEFT THE COURTROOM. ALL COUNSEL AND THE DEFENDANT ARE PRESENT. MR. WADE.

1720

MR. WADE: THANK YOU, YOUR HONOR. WE'RE AT THAT POINT WHERE I'VE GONE THROUGH EVERYTHING BUT THE ISSUES THAT WE DISCUSSED THIS MORNING. I THINK I MADE THE COMMITMENT TO THE COURT THAT I WOULDN'T DO IT IN THE MORNING, BUT WE'RE NOW AT THE POINT WHERE THAT'S ESSENTIALLY ALL I HAVE LEFT.

1721

JUDGE DAVILA: SO WHAT YOU HAVE LEFT IS THAT YOU WOULD LIKE TO INQUIRE, AS YOU'VE TOLD ME THIS MORNING, REGARDING THESE THREE ISSUES, INVITAE, UBIOME -- IS THAT WHAT IT'S CALLED?

1722

MR. WADE: UBIOME.

1723

JUDGE DAVILA: -- AND PERKIN ELMER; IS THAT RIGHT?

1725

JUDGE DAVILA: ANYTHING FURTHER ON THOSE TOPICS?

1726

MR. WADE: I HAVE NOTHING FURTHER APART FROM WHAT WE DISCUSSED THIS MORNING.

1727

JUDGE DAVILA: OKAY. MR. BOSTIC.

1728

MR. BOSTIC: YOUR HONOR, JUST VERY BRIEFLY. I THINK IN LIGHT OF THE BREADTH AND THE STYLE OF THE CROSS-EXAMINATION HERE, IT JUST UNDERLIES THE GOVERNMENT'S CONCERNS ABOUT WHAT IT WOULD LOOK LIKE TO GO INTO THESE TOPICS. I THINK PROBING THESE TOPICS REALLY IS ASKING FOR EXTRANEOUS ISSUES TO BE LITIGATED IN A WAY THAT THIS TRIAL JUST IS NOT SET UP TO DO. I ALSO, WHEN IT COMES TO EXTRINSIC EVIDENCE AND WHETHER DOCUMENTS THEMSELVES WILL BE ADMITTED INTO EVIDENCE, I HEARD MR. WADE SAY THAT HE DOESN'T NECESSARILY INTEND TO ADMIT MANY OR ANY OF THE DOCUMENTS THAT THE COURT HAS SEEN. BUT THAT DOESN'T ALLEVIATE THE GOVERNMENT'S CONCERNS IN LIGHT OF AN APPROACH THAT MR. WADE HAS BEEN TAKING TO REFRESHING THE WITNESS'S RECOLLECTION WHEREIN HE ASKS THE WITNESS A QUESTION AND THEN TAKES OUT A DOCUMENT AND ESSENTIALLY READS IT INTO EVIDENCE. THAT IS AS GOOD AS PUBLISHING THE CONTENTS OF THAT DOCUMENT TO THE JURY AND REPRESENTING TO THE JURY THAT THERE IS A PIECE OF EVIDENCE THAT CONTAINS THIS INFORMATION. GIVEN THAT APPROACH, THERE'S NOT MUCH DIFFERENCE BETWEEN I THINK THE ANTICIPATED STYLE OF QUESTIONING AND JUST ADMITTING THOSE DOCUMENTS. SO THAT ONLY INCREASES THE GOVERNMENT'S CONCERNS.

1729

JUDGE DAVILA: ANYTHING FURTHER?

1730

MR. WADE: I DON'T HAVE ANYTHING FURTHER TO WHAT WE RAISED THIS MORNING APART FROM THERE'S BEEN 702 TYPE OF EVIDENCE THAT HAS BEEN COMING OUT OF THIS WITNESS THROUGHOUT HIS DIRECT EXAMINATION. THAT PUTS SQUARELY AT ISSUE HIS COMPETENCE, AND I THINK IT'S NECESSARY FOR MS. HOLMES TO BE ABLE TO CONFRONT THAT.

1731

JUDGE DAVILA: I THINK SHE'S DONE THAT THROUGH YOU, SIR, FOUR AND A HALF DAYS OF IT. I THINK THAT'S WHAT YOUR EXAMINATION HAS DONE. YOU WERE GRILLING HIM AND I THINK YOUR EXAMINATION SHOWS THAT YOU WERE CHALLENGING HIS COMPETENCY IN SEVERAL REGARDS. WE'VE HAD FOUR DAYS OF THAT. I THINK YOU'VE DONE THAT. YOU'VE ACCOMPLISHED THAT. I THINK WHAT YOU'RE ASKING TO DO IS TO CONTINUE WITH THAT BECAUSE THE COMPETENCY IS AN ISSUE, AS YOU SAY. I LOOK AT THE ISSUES THAT WE DISCUSSED THIS MORNING AND IT DOES SEEM TO BE THAT IT'S REALLY CHARACTER EVIDENCE THAT YOU'RE SEEKING TO ADMIT HERE, AND THAT IS THE CHARACTER FOR COMPETENCY OR LACK THEREOF. WE TALKED ABOUT 608(B) AND SOME OF THESE OTHER AREAS OF ADMISSION FOR THIS TYPE OF EVIDENCE. FIRST OF ALL, LET ME JUST -- I'M SORRY, WAS IT UBIOME, UBIOME?

1733

JUDGE DAVILA: THANK YOU. AS TO THAT EVIDENCE, AS WE DISCUSSED THIS MORNING, THE EVIDENCE THAT DR. ROSENDORFF WAS THERE, THERE WAS -- I THINK IS THIS THE LAB WHERE THERE WAS A FEDERAL INVESTIGATION, INDICTMENTS, AND A PENDING CRIMINAL CASE.

1734

MR. BOSTIC: CORRECT, YOUR HONOR.

1735

JUDGE DAVILA: UNDER 403, I THINK THAT'S MORE PREJUDICIAL THAN PROBATIVE TO ALLOW YOU TO EXAMINE ON THAT. THE ISSUES INVOLVED IN THAT CASE, AS I UNDERSTAND FROM OUR CONVERSATION THIS MORNING, WERE CRIMINAL IN NATURE. IT SOUNDS LIKE THAT WAS A HEALTH CARE FRAUD IN REBILLING THAT DID NOT RELATE TO OR DID NOT HAVE, AT LEAST BASED ON WHAT YOU TOLD ME, DID NOT HAVE ANYTHING TO DO WITH THE OPERATION OF THE LAB PER SE. THE INDICTMENT -- UNLESS YOU TELL ME DIFFERENTLY, MR. BOSTIC AND MR. WADE, THE INDICTMENT WAS NOT AN INDICTMENT ALLEGING ANY FRAUD INVOLVING THE LABORATORY OR ANYTHING ABOUT THE LAB. SO I DO SEE THAT THAT, UNDER A 403 ANALYSIS, THAT -- TO ALLOW YOU, MR. WADE, TO PROBE ON THAT ISSUE AND HIS INVOLVEMENT THERE IS MORE PREJUDICIAL THAN PROBATIVE. IT WOULD CALL THE JURY THEN TO CONJECTURE AND TO SPECULATE THAT PERHAPS HE'S INVOLVED IN A FEDERAL CRIMINAL INVESTIGATION, WHICH FROM WHAT YOU'VE TOLD ME, HE'S NOT. HE'S NOT, OTHER THAN HIS EMPLOYMENT THERE. HE'S NOT A SUBJECT TO IT.

I THINK YOU TOLD ME HE MIGHT HAVE BEEN A WITNESS. BUT EVEN IF HE WAS, MR. WADE, THAT'S 403. THAT'S MORE PREJUDICIAL THAN PROBATIVE. AGAIN, LOOKING AT THE JOB THAT YOU'VE DONE OVER THE LAST FOUR DAYS WITH THIS WITNESS, YOU HAVE CHALLENGED HIS COMPETENCY OVER THOSE DAYS WITH THE VARIOUS DOCUMENTS THAT WE HAVE IN EVIDENCE HERE. SO AS TO THAT, I WOULD NOT ALLOW YOU TO GO INTO ANY EXAMINATION ON THAT. THE INVITAE -- I THINK I'M PRONOUNCING THAT CORRECTLY, I HOPE I AM -- IT SEEMS LIKE YOU WANT TO GO INTO THAT ALSO, AND THAT'S ANOTHER AREA WHERE YOU WISH TO PROBE HIS COMPETENCY OF THE -- OF HIS PERFORMANCE THERE AS LAB DIRECTOR, EITHER PART-TIME OR NOT, WHATEVER HIS ENGAGEMENT IS. AGAIN, THIS GOES TO THE -- I BELIEVE IT GOES TO A CHARACTER QUALITY AND IT'S, FROM THE COURT'S PERSPECTIVE, I BELIEVE IT'S INAPPROPRIATE CHARACTER EVIDENCE FOR WHAT YOU'RE SEEKING TO ACCOMPLISH. LET ME TURN, THOUGH, TO THE -- IS IT PERKIN ELMER?

1736

MR. WADE: CORRECT.

1737

JUDGE DAVILA: THAT INVOLVES THE CMS INSPECTION. AND THIS IS A CLOSER CASE. AND THIS IS SOMETHING THAT, MR. WADE, AN AREA, PARDON ME, WHERE I DO THINK THE COURT WOULD PERMIT YOU SOME LIMITED, LIMITED EXAMINATION. THE FACTORS HERE ARE THE FACT THAT AS I UNDERSTAND IT, THE CMS INSPECTORS IN THERANOS WERE THE SAME INSPECTORS WHO WERE INVOLVED IN THE PERKIN ELMER SITUATION. THIS GOES, MR. WADE, TOWARDS YOUR BIAS, YOUR BIAS ISSUE. I DO THINK THERE MIGHT BE SOME RELEVANCE AS TO POTENTIAL ISSUE OF BIAS. I DO BELIEVE THAT THE DEFENSE WOULD BE PERMITTED AND IT'S APPROPRIATE TO ALLOW THE DEFENSE TO PROBE, TO PROBE AN ISSUE OF BIAS. WE'VE TALKED AND WE ALL KNOW THAT BIAS IS ALWAYS RELEVANT, BUT -- AND I DO THINK FOR MS. HOLMES TO PRESENT HER DEFENSE, IF SHE WISHES TO DO THAT, I DO THINK IT'S APPROPRIATE TO ALLOW THE DEFENSE TO PROBE ANY ISSUES OF BIAS THAT MAY EXIST. THE BIAS THAT IS REPRESENTED BY MR.

WADE IS THAT THESE TWO INSPECTORS ARE THE SAME INSPECTORS THAT WERE INVOLVED IN THERANOS AND THEY'RE ALSO INVOLVED IN THE INSPECTION AT PERKIN ELMER. BUT, MR. WADE, THIS IS AN AREA WHERE YOU'LL, YOU'LL BE PERMITTED TO PROBE, BUT YOU HAVE TO PROBE LIGHTLY. THE ISSUE REALLY IS WHETHER OR NOT DR. ROSENDORFF, WHETHER HIS TESTIMONY HERE IS IN ANY WAY SHAPED, FOCUSSED, HIS ANSWERS TO YOUR QUESTIONS AND THE GOVERNMENT QUESTIONS ARE IN ANY WAY FOCUSSED OR SHAPED BY A PERSONAL INTEREST, BIAS, SUCH THAT AS YOU TOLD ME THIS MORNING, SUCH THAT IT MIGHT IMPAIR EITHER HIS FUTURE CAREER OR ANY LIABILITY HE MIGHT HAVE. THAT'S A BROAD, A BROAD AREA. BUT I'M NOT GOING TO PERMIT YOU TO GET INTO, GET INTO THE NATURE OF ANY INVESTIGATION, THE QUALITY OF THE INVESTIGATION, HIS SPECIFIC ROLE IN IT. I THINK THEN WE GET INTO WHAT 608(B), AND I DON'T MEAN TO CONFLATE THESE TWO, BUT WHAT 608(B) -- THE PURPOSE OF 608(B) IS TO AVOID MINI TRIALS AND TO AFFORD EFFICIENCY OF THE PRESENTATION OF THE EVIDENCE. SO I WILL PERMIT YOU TO PROBE THE BIAS ISSUE, BUT NOT TO GET INTO -- I'M GOING TO -- I'M JUST GOING TO BE CANDID WITH YOU. I'M GOING TO SHUT YOU DOWN IF YOU GO A LITTLE TOO FAR AS TO ANY SPECIFICS. I'M GOING TO GIVE YOU SOME LATITUDE, AND I THINK YOU'RE PERMITTED SOME LATITUDE ABOUT THAT TO DEVELOP THE BIAS, AND WE'LL TAKE ANOTHER TEN MINUTES AND ALLOW YOU TO COLLECT YOUR THOUGHTS ON THAT AND HOW YOU WANT TO APPROACH THAT.

1738

MR. WADE: AND IF I COULD JUST INQUIRE SO I DO NOT CROSS THE LINE THAT THE COURT HAS IN MIND.

1740

MR. WADE: THERE ARE CERTAIN CONCLUSIONS THAT WERE REACHED AND NOTICES GIVEN BY THE REGULATORS THAT SORT OF TRIGGER THOSE CONSEQUENCES AND HIS RECOGNITION OF THOSE CONSEQUENCES, AND SO MY INTENT WOULD BE TO NOT GO IN DETAIL INTO ANY OF THOSE. MY INTENT WOULD BE TO NOT INTRODUCE THE DOCUMENTS THEMSELVES, BUT JUST TO NOTE THAT -- BECAUSE THAT'S THE REASON WHY HE -- THAT'S THE REASON WHY HE IS IN JEOPARDY RIGHT NOW.

1741

JUDGE DAVILA: WELL, MAYBE, MAYBE NOT. YOUR PERSPECTIVE IS HE'S IN JEOPARDY. MAYBE HE FEELS HE'S IN JEOPARDY. THAT'S THE REASON FOR THE QUESTIONS, ISN'T IT? AND THAT IS -- PERHAPS THAT IS THE WAY TO ASK THE QUESTIONS. I'M NOT GOING TO TELL A SEASONED VETERAN LIKE YOU HOW TO PUT YOUR CASE ON.

1742

MR. WADE: UNDERSTOOD.

1743

JUDGE DAVILA: BUT THE QUESTION WAS, DO YOU HAVE CONCERNS? WAS THERE AN INVESTIGATION FROM CMS AT PERKINS? DID IT INVOLVE THE SAME INSPECTORS HERE? I DON'T KNOW, MAYBE THAT'S EVEN A LITTLE CLOSER. BUT THAT'S THE ISSUE.

1745

JUDGE DAVILA: AND THEN AS A RESULT OF THAT INSPECTION, DO YOU FEEL SOME ANXIETY ABOUT -- HAS THAT DIRECTED YOU? HAS THAT FOCUSSED YOU? AGAIN, I AM NOT TELLING YOU WHAT QUESTIONS TO ASK. I HOPE YOU SEE THE GENERAL AREA, THOUGH.

1747

JUDGE DAVILA: BECAUSE THAT'S REALLY THE ISSUE. THE FACT THAT THERE WAS AN INSPECTION AT THIS LAB AND THE FACT THAT THE SAME INSPECTORS WERE INVOLVED IN THERANOS, THERE'S SOME SYMBIOSIS, SOME SYMBIOTIC RELATIONSHIP AT LEAST BY EMPLOYMENT. MAYBE IT'S JUST PURE COINCIDENCE. BUT NONETHELESS, I THINK BECAUSE OF WHAT IT IS, I'M GOING TO ALLOW YOU TO PROBE THAT, BUT NOT TO GET INTO, ISN'T IT A FACT THAT THE LAB WAS ALSO ENGAGED IN X, Y, Z? OR THEIR LAB WAS THIS? YOU USED THE WORD "CHAOS" I THINK EARLIER TO DESCRIBE NEWARK OR SOMETHING.

1748

MR. WADE: NOT NEWARK. I THINK I WAS DESCRIBING WHAT THE TEXT MESSAGES WITH WHICH MY UNDERSTANDING WAS THAT WE HAD THE FOUNDATION.

1749

JUDGE DAVILA: I'M JUST USING THAT AS AN EXAMPLE. I'M NOT CRITICIZING YOUR WORD CHOICE.

1750

MR. WADE: NO. I UNDERSTAND.

1751

JUDGE DAVILA: BUT I AM GOING TO PERMIT YOU TO DO THAT. I THINK THAT'S RELEVANT FOR EXPLORATION OF WHETHER OR NOT THIS WITNESS HAS ANY BIAS, WHETHER OR NOT THIS WITNESS'S RESPONSES OVER THE LAST DAYS HAVE BEEN THE RESULT OF CONCERN. THAT'S -- AND HIS ANSWERS WILL BE WHAT THEY ARE, AND THE JURY CAN CERTAINLY GIVE IT WHATEVER WEIGHT THEY FEEL IS APPROPRIATE. THAT'S THE PURPOSE FOR BIAS. LET ME ALSO INDICATE THERE ON THE RECORD -- AND I MENTIONED I STARTED MY COMMENTS WITH YOUR FOUR AND A HALF DAYS OF EXAMINATION, THE ISSUE OF CUMULATIVE COMES UP ALSO. THE PURPOSE TO EXAMINE ON THESE ISSUES WAS TO DIMINISH THE CREDIBILITY OF THIS PARTICULAR WITNESS. I THINK YOU'VE ACCOMPLISHED THAT FOR THE JURY OVER THE LAST FOUR DAYS, AT LEAST SUCH THAT THEY CAN WEIGH IT AND GIVE IT WHATEVER WEIGHT THEY THINK IS APPROPRIATE. SO THERE IS SOME CUMULATIVE NATURE AS WELL IN ALL OF THIS, WHICH ALSO IMPARTS A 403 ANALYSIS AS TO THE ADDITIONAL TIME THAT WOULD BE REQUIRED TO PROBE INTO OTHER MATTERS, AND THAT'S REALLY MORE TOWARDS THE OTHER TWO EXAMPLES WE TALKED ABOUT, BUT IT ALSO TOUCHES ON THIS AS WELL, THOUGH. SO THAT IS MY POSITION ON THIS AREA. IS THAT HELPFUL TO YOU?

1752

MR. WADE: I DO UNDERSTAND, YOUR HONOR. OBVIOUSLY WITH RESPECT TO THE BREADTH OF THE EXAMINATION, YOU KNOW, WE HAVE SUBSTANTIAL CONCERNS ABOUT WHAT WAS PULLED OUT ABOUT IN DIRECT UNDER NAPUE, N-A-P-U-E, AND OTHERWISE, AND SO WE FELT WE NEEDED THE BREADTH THAT WE DID IN ORDER TO CLARIFY THE RECORD.

1753

JUDGE DAVILA: I HOPE YOU DON'T TAKE ME BEING CRITICAL OF YOU DOING WHAT YOU DID, BUT -- AND I'M NOT. I'M JUST OBSERVING THAT WE HAD FOUR DAYS AND YOU WERE, YOU KNOW, YOU WERE VERY THOROUGH WITH YOUR EXAMINATION, YOUR CROSS-EXAMINATION. SO THAT'S A FACTOR ALSO IN THIS ANALYSIS, AGAIN, GOING TO THE CUMULATIVE NATURE OF IT, THE 403 TIME ISSUE. MR. BOSTIC, ANYTHING FURTHER?

1754

MR. BOSTIC: NOTHING FURTHER, YOUR HONOR, EXCEPT TO SAY THAT I ANTICIPATE, HAVING NOT DISCUSSED THESE ISSUES WITH THIS WITNESS AT LENGTH, OR PERHAPS AT ALL, I'M NOT SURE WHAT THE WITNESS WILL ANSWER IN RESPONSE TO MR. WADE'S QUESTIONS. BUT I ANTICIPATE THAT THEY WILL NOT BE THE ANSWERS THAT ARE SATISFACTORY TO MR. WADE, TO BE FRANK. I UNDERSTAND THE COURT'S RULING TO FORECLOSE ANY EFFORT BY THE DEFENSE TO HIGHLIGHT OR EMPHASIZE THE SEVERITY OF THE CMS INSPECTION OR FINDINGS AT PERKIN ELMER IN AN EFFORT TO IMPEACH THAT ANSWER. BUT I'M GUIDED BY THE COURT, AS I'M SURE THE DEFENSE IS.

1755

MR. WADE: HE FACES THOSE CONSEQUENCES BECAUSE OF THE CIRCUMSTANCES THAT THEY'RE IN AS A MATTER OF LAW, SO -- WHICH HE CLARIFIED IN A DIFFERENT CONVERSATION WITH MR. YAMAMOTO, NOT THE ONE THAT I EXPLORED WITH HIM HERE, BUT WITH RESPECT TO PERKIN ELMER. THERE'S AN EMAIL THAT DOCUMENTS HIS AWARENESS AND CONCERN ABOUT THE FACT THAT HE COULD LOSE HIS LICENSE.

1756

JUDGE DAVILA: SURE. AND THAT'S -- BUT, MR. WADE, YOU DON'T HAVE TO GET INTO ALL OF THE NUANCES OF WHAT IT WAS. ISN'T IT A FACT THAT THE LAB HAD 47, 50 DEFICIENCIES? YOU WERE AWARE OF IT? YOU KNEW, ET CETERA, ET CETERA. THAT'S PILING ON. THAT'S NOT WHAT THIS IS ABOUT. THIS IS CMS DID AN INVESTIGATION, MR. YAMAMOTO WAS THERE, HE'S THE SAME GENTLEMAN THAT YOU TALKED WITH AT THERANOS, AND NOW HE WAS INVOLVED IN AN INSPECTION OF SOME SORT. HE WAS INVOLVED WITH YOUR CURRENT EMPLOYER, DOES THAT CAUSE YOU ANY -- AND THEN YOU'LL FILL IN THE BLANK, I'M SURE, WITH THE APPROPRIATE QUESTION. BUT NOT GOING TO GET INTO THE DETAILS OF THAT. I UNDERSTAND THAT YOU WOULD LIKE TO GET INTO THE FOUNDATION OF ALL OF THAT, BUT WHAT IS REALLY INVOLVED HERE IS THE CMS CHARACTERS ARE THE SAME AS IN THERANOS. HE HAS SOME INTIMACY WITH THEM IN HIS FORMER EMPLOYMENT, HE NOW HAS RENEWED THAT INTIMACY IN HIS CURRENT EMPLOYMENT. HE MAY HAVE CONCERNS ABOUT HIS FUTURE EMPLOYMENT, AND HAS THAT IN ANY WAY SHAPED ANY OF THE TESTIMONY THAT HE'S GIVEN TODAY SUCH THAT HE FAVORS THE GOVERNMENT, SUCH THAT HE FAVORS THERANOS? I THINK IT'S PRETTY STRAIGHTFORWARD, I HOPE. I THINK IT IS.

1757

MR. WADE: I UNDERSTAND THE DIRECTION OF THE COURT.

1758

JUDGE DAVILA: BUT WE'LL GIVE YOU TEN MINUTES TO PUT IT ALL TOGETHER.

1759

MR. WADE: GREAT. THANK YOU, YOUR HONOR.

1760

JUDGE DAVILA: GREAT. THANK YOU.

1761

COURT CLERK: COURT IS IN RECESS.

1762

JUDGE DAVILA: AND THEN -- I'M SORRY. MR. BOSTIC, DO YOU THEN BEGIN YOUR REDIRECT EXAMINATION THIS AFTERNOON?

1763

MR. BOSTIC: YES, YOUR HONOR.

1764

JUDGE DAVILA: GREAT. THANK YOU VERY MUCH.

1765

(RECESS FROM 1:12 P.M. UNTIL 1:39 P.M.)

1766

(JURY IN AT 1:39 P.M.)

1767

JUDGE DAVILA: ALL RIGHT. THANK YOU. WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. THE WITNESS IS ON THE STAND. DO YOU HAVE SOME ADDITIONAL QUESTIONS, MR. WADE?

1768

MR. WADE: YES, YOUR HONOR, JUST A FEW MORE QUESTIONS.

1770

BY MR. WADE:

Cross 2Cross 2 Adam Rosendorff Lance A. Wade
1771

MR. WADE: DR. ROSENDORFF, I BELIEVE YOU'VE BEEN A LAB DIRECTOR FOR ABOUT 13 YEARS.

1773

MR. WADE: SINCE ABOUT 2008?

1775

MR. WADE: AND DURING THAT TIME, WE'VE TALKED ABOUT HOW YOU FREQUENTLY WORKED IN THE CLIA ENVIRONMENT; RIGHT?

1777

MR. WADE: WHERE THE REGULATORS ASSESS THE PERFORMANCE OF THE LAB UNDER THE CLIA REGULATIONS?

1779

MR. WADE: AND WE'VE TALKED ABOUT THOSE REGULATIONS AT LENGTH IN THIS EXAMINATION; CORRECT?

1781

MR. WADE: AND AS PART OF THE WORK -- AS PART OF THE ENFORCEMENT OF THESE CLIA REGULATIONS, OCCASIONALLY THE CENTER FOR THE CMS WILL DO INSPECTIONS; RIGHT?

1783

MR. WADE: AND YOU'VE HAD EXPERIENCE WITH DIFFERENT INSPECTIONS OVER THE YEARS; CORRECT?

1785

MR. WADE: AND ON OTHER OCCASIONS YOU'D INTERACT WITH REGULATORS; CORRECT?

1787

MR. WADE: LIKE WE JUST TALKED ABOUT YOUR INTERACTIONS WITH MR. YAMAMOTO. DO YOU RECALL?

1788

ADAM ROSENDORFF: I RECALL PLACING A PHONE CALL TO CMS AND SPEAKING TO MR. YAMAMOTO WHILE I WAS AT THERANOS.

1789

MR. WADE: RIGHT, RIGHT. WE WERE JUST TALKING ABOUT THAT IN YOUR PRIOR TESTIMONY. DO YOU RECALL THAT?

1791

MR. WADE: OKAY. THE CURRENT LAB, I THINK YOU MENTIONED YESTERDAY, IS A LAB THAT IS ALSO IN CALIFORNIA; IS THAT RIGHT?

1793

MR. WADE: AND REMIND ME WHERE THAT LAB IS LOCATED?

1794

ADAM ROSENDORFF: IT IS LOCATED IN VALENCIA, CALIFORNIA.

1795

MR. WADE: OKAY. AND VALENCIA, IS THAT JUST NORTH OF L.A.?

1797

MR. WADE: AN HOUR, HOUR AND A HALF OR SO?

1799

MR. WADE: AND AS PART OF -- AND YOU SERVE AS THE CLIA LAB DIRECTOR?

1801

MR. WADE: AND AS PART OF YOUR SERVICE AS THE CLIA LAB DIRECTOR, CMS SUBJECTED THAT LAB TO A COMPLAINT SURVEY?

1803

MR. WADE: AND AS PART OF THAT, THEY CAME IN AND DID THE KIND OF INVESTIGATION THAT WE'VE TALKED ABOUT THE OTHER DAY, IS THAT FAIR, WHEN WE TALKED ABOUT THE 2013 INSPECTION AT THERANOS?

1804

ADAM ROSENDORFF: NO. CMS CAME IN EARLIER THIS YEAR. MOST OF THE PROCEEDINGS WERE DOCUMENT REVIEW AND REVIEW OF THE LIS. IT WAS MR. YAMAMOTO AND ANOTHER INDIVIDUAL WHO WAS ASSISTING HIM.

1805

MR. WADE: IS THAT JOSHUA COHEN?

1807

MR. WADE: OKAY. AND YOU UNDERSTAND THE HEAD OF THE REGION IS KAREN FULLER?

1809

MR. WADE: AND SHE'S SOMEONE WHO YOU AT LEAST RECEIVE CORRESPONDENCE FROM IN CONNECTION WITH THAT SURVEY?

1810

ADAM ROSENDORFF: THE CORRESPONDENCE WAS FROM -- YES, YES, YES.

1811

MR. WADE: AND SHE'S THE REGIONAL DIRECTOR FOR THE WESTERN STATES?

1813

MR. WADE: OKAY. AFTER THAT -- AFTER THAT INSPECTION, THEY PROVIDED YOU, THEY PROVIDED YOU A NOTICE IDENTIFYING SOME MATTERS; IS THAT RIGHT?

1815

MR. WADE: AND THAT WAS IN JULY -- INITIALLY THEY PROVIDED A NOTICE IN MAY OF '21?

1816

ADAM ROSENDORFF: I BELIEVE SO.

1817

MR. WADE: MAY 6TH. DOES THAT SOUND FAMILIAR? AND THERE WAS SOME RESPONSES WHERE YOU PROVIDED INFORMATION TO CMS?

1819

MR. WADE: AND THEN THEY PROVIDED ANOTHER NOTICE IN JULY OF 2021. DO YOU RECALL THAT?

1821

MR. WADE: AND YOU'RE AWARE THAT IF -- LET ME STRIKE THAT. IN CONNECTION WITH THAT NOTICE, THAT CREATED SOME IMPLICATIONS FOR YOU PERSONALLY; IS THAT RIGHT?

1822

ADAM ROSENDORFF: I DON'T HAVE THE TEXT OF THE JULY NOTICE IN FRONT OF ME SO I CAN'T COMMENT ON THAT, YEAH.

1823

JUDGE DAVILA: I DON'T THINK YOU NEED THAT.

1824

MR. WADE: I DON'T THINK WE NEED THAT.

1825

MR. WADE: DO YOU RECALL AFTER YOU GOT THE NOTICE YOU HAD A TELEPHONE CONVERSATION WITH MR. YAMAMOTO ABOUT POSSIBLE IMPLICATIONS --

1827

MR. WADE: -- FOR YOU PERSONALLY?

1828

ADAM ROSENDORFF: YES, I DID. YEAH.

1829

MR. WADE: AND IN CONNECTION WITH THAT CONVERSATION WITH MR. YAMAMOTO, DID YOU UNDERSTAND DEPENDING UPON THE FINAL OUTCOME OF THOSE MATTERS THAT YOU COULD -- YOUR LICENSE TO BE A LAB DIRECTOR COULD BE SUSPENDED?

1830

ADAM ROSENDORFF: YES, FOR AT LEAST TWO YEARS, CORRECT.

1831

MR. WADE: I HAVE NO FURTHER QUESTIONS.

1832

JUDGE DAVILA: THANK YOU. MR. BOSTIC, DO YOU HAVE REDIRECT?

1833

MR. BOSTIC: I DO, YOUR HONOR. MAY I PROCEED, YOUR HONOR?

1834

JUDGE DAVILA: YES, PLEASE.

RedirectRedirect Adam Rosendorff John C. Bostic
1835

REDIRECT EXAMINATION BY MR. BOSTIC:

1836

MR. BOSTIC: GOOD AFTERNOON, DR. ROSENDORFF.

1837

ADAM ROSENDORFF: GOOD AFTERNOON, SIR.

1838

MR. BOSTIC: I'D LIKE TO ASK YOU SOME FOLLOW-UP QUESTIONS ABOUT SOME TOPICS THAT YOU DISCUSSED WITH MR. WADE. FIRST, DO YOU RECALL QUESTIONS THAT MR. WADE ASKED YOU ABOUT PREVIOUS MEETINGS THAT YOU HAD WITH THE GOVERNMENT?

1840

MR. BOSTIC: AND WHEN YOU MET WITH THE GOVERNMENT, WERE THOSE MEETINGS VOLUNTARY OR WERE YOU FORCED TO MEET WITH THE GOVERNMENT?

1842

MR. BOSTIC: AND WHY DID YOU DECIDE TO MEET WITH THE GOVERNMENT AND SHARE INFORMATION ABOUT THERANOS?

1843

ADAM ROSENDORFF: I WANTED TO BE FULLY COOPERATIVE WITH THE GOVERNMENT AND THEIR INVESTIGATION. I WANTED THE STORY TO COME OUT. I WANTED JUSTICE TO BE SERVED, AND I BASICALLY SAW IT AS A PUBLIC SERVICE IN ESSENCE TO COOPERATE WITH THE GOVERNMENT AND IN ANY WAY THAT I COULD, YEAH.

1844

MR. BOSTIC: I WANT YOU TO THINK ABOUT ALL OF THOSE MEETINGS AS A WHOLE. DO YOU HAVE THOSE MEETINGS IN YOUR MIND?

1846

MR. BOSTIC: AT ANY POINT DURING THOSE MEETINGS DID ANY REPRESENTATIVE OF THE GOVERNMENT TELL YOU HOW TO TESTIFY AT TRIAL OR ATTEMPT TO SHAPE YOUR TESTIMONY?

1847

ADAM ROSENDORFF: NO, NOT AT ALL.

1848

MR. BOSTIC: DID ANYONE FROM THE GOVERNMENT AT ANY OF THOSE MEETINGS MAKE ANY PROMISES TO YOU ABOUT BENEFITS THAT YOU MIGHT OBTAIN IF YOU TESTIFIED IN A CERTAIN WAY DURING THIS TRIAL?

1849

ADAM ROSENDORFF: NO, NOT AT ALL. ON THE CONTRARY, I'VE MADE SACRIFICES IN THE PROCESS.

1850

MR. BOSTIC: AND WHAT SACRIFICES ARE YOU REFERRING TO?

1851

ADAM ROSENDORFF: THE STRESS OF MEETING WITH THE GOVERNMENT, TRAVELLING TO MEET WITH THE GOVERNMENT FROM SAN DIEGO TO TALK TO THE S.E.C. IN SAN FRANCISCO, ESSENTIALLY HAVING THIS ISSUE ON MY MIND, HAVING TO RELIVE VERY UNPLEASANT EXPERIENCES WHILE AT THERANOS, ET CETERA, THE MEDIA ATTENTION, ET CETERA, YEAH.

1852

MR. BOSTIC: OKAY. WE CAN MOVE ON FROM THAT TOPIC. DURING THE CROSS-EXAMINATION YOU WERE ASKED SOMETHING TO THE EFFECT OF WHETHER YOU KNOWINGLY RELEASED TEST RESULTS AT THERANOS. DO YOU REMEMBER THAT QUESTION?

1854

MR. BOSTIC: AND WHAT WAS YOUR ANSWER TO THAT QUESTION?

1856

MR. BOSTIC: IN YOUR EXPERIENCE AS A LAB DIRECTOR, IS IT ALWAYS POSSIBLE TO IDENTIFY INACCURATE TEST RESULTS BEFORE THEY WENT OUT?

1857

ADAM ROSENDORFF: NO. IN THE VAST, VAST MAJORITY OF THE CASES PROBLEMS COME TO LIGHT AFTER THE RESULTS HAVE BEEN REPORTED. AS A LAB DIRECTOR ONE IMPLEMENTS ALL OF THE SAFEGUARDS AND QUALITY CONTROL PROCEDURES TO ENSURE THE HIGHEST ACCURACY AND INTEGRITY OF THE RESULTS, BUT IN THE CASE OF THERANOS THE PROBLEMS EMERGED AFTER THOSE RESULTS WERE RELEASED.

1858

MR. BOSTIC: IN OTHER WORDS, RESULTS CAN ONLY BE IDENTIFIED AS INACCURATE AFTER THEY HAD GONE OUT THE DOOR?

1859

ADAM ROSENDORFF: FOR THE MOST PART, YES.

1860

MR. BOSTIC: HOW ABOUT EVEN AFTER THE LAB RESULTS GO OUT, IS IT POSSIBLE AT THAT POINT TO IDENTIFY EACH AND EVERY INACCURATE TEST RESULT THAT A LAB HAS PUT OUT?

1861

ADAM ROSENDORFF: NO, NOT DEFINITIVELY, NO.

1862

MR. BOSTIC: WHY NOT?

1863

ADAM ROSENDORFF: YOU -- FOR ONE THING, YOU DON'T KNOW WHAT THE ACTUAL VALUE IS. YOU DON'T KNOW WHAT THE BIOLOGICAL VALUE SHOULD BE. YOU RELY ON A ROBUST TESTING METHOD AND TECHNOLOGY -- YOU RELY ON TECHNOLOGY TO A HUGE EXTENT. IT'S REALLY -- AS I SAID, ONE PUTS SAFEGUARDS IN PLACE SUCH AS PROFICIENCY TESTING AND QC TO MITIGATE THE POTENTIAL FOR ERROR. IT DOES NOT ELIMINATE THE POTENTIAL FOR ERROR. I DON'T KNOW IF THAT ANSWERS YOUR QUESTION. YEAH.

1864

MR. BOSTIC: I THINK IT DOES. AND LET ME ASK A FOLLOWUP, WHICH IS, WHAT ARE THE WAYS IN WHICH IT'S POSSIBLE TO IDENTIFY AN INACCURATE TEST RESULT AFTER THE FACT? WHAT ARE THE DIFFERENT WAYS?

1865

ADAM ROSENDORFF: SO, FOR INSTANCE, A FREE T4 COULD BE VERY HIGH, BUT THE TSH COULD BE VERY NORMAL, AND WE KNOW FROM PHYSIOLOGY THAT TSH COULD BE LOW AND THAT SUGGESTS A PROBLEM WITH TSH.

1866

MR. BOSTIC: SO, IN OTHER WORDS, YOU MIGHT HAVE A SITUATION WHERE ONE TEST RESULT IS INCOMPATIBLE WITH ANOTHER TEST RESULT FROM THE SAME --

1867

ADAM ROSENDORFF: CORRECT, CORRECT. ANOTHER EXAMPLE WOULD BE THE CHOLESTEROL WHERE JUST THE MATH -- WHAT IS MEASURED DOESN'T COMPUTE WITH THE MATH OF WHAT THE ACTUAL RESULT SHOULD BE.

1868

MR. BOSTIC: UH-HUH. SO AGAIN, INTERNAL INCONSISTENCE BETWEEN TWO DIFFERENT RESULTS?

1869

ADAM ROSENDORFF: YES, OR A SPATE OF ABNORMALLY LOW RESULTS THAT IS STATISTICALLY VERY UNLIKELY.

1870

MR. BOSTIC: HOW ABOUT COMPARISON BETWEEN A RESULT OBTAINED FROM ONE METHOD VERSUS A RESULT OBTAINED FROM ANOTHER PROVEN METHOD? IS THAT A METHOD THAT COULD BE USED TO IDENTIFY AN INACCURATE RESULT?

1871

ADAM ROSENDORFF: WELL, AT THERANOS THOSE KINDS OF TROUBLESHOOTING FOR THE MOST PART WOULD RELY ON VENOUS BLOOD SAMPLES THAT WOULD BE RUN ON A THERANOS METHOD AND A PREDICATE METHOD. IT DID NOT TAKE INTO ACCOUNT ISSUES WITH THE ACTUAL CTN TECHNOLOGY OR INDEED DIFFERENCES BETWEEN CAPILLARY BLOOD AND VENOUS BLOOD.

1872

MR. BOSTIC: IN YOUR EXPERIENCE AT THERANOS, DID YOU EVER ENCOUNTER SITUATIONS WHERE YOU CAME TO DOUBT A THERANOS LAB RESULT BECAUSE OF A RESULT FROM ANOTHER LAB AROUND THE SAME TIME PERIOD?

1873

ADAM ROSENDORFF: YES. I BELIEVE THE TESTOSTERONE IS AN EXAMPLE OF THAT, YEAH.

1874

MR. BOSTIC: HOW ABOUT PATIENT FACTORS? IS THERE SOMETIMES -- OR IS THERE EVER INFORMATION ABOUT THE WAY A PATIENT PRESENTS OR WHAT IS GOING ON WITH A PATIENT THAT CAN CALL INTO QUESTION LABORATORY RESULTS?

1875

ADAM ROSENDORFF: UM, YES. IN THE CASE OF A PATIENT TAKING COUMADIN, FOR INSTANCE, YOU EXPECT THE PT TO BE PROLONGED. IF YOU SEE A SHORT PT, THAT'S INCONSISTENT WITH A PATIENT TAKING COUMADIN.

1876

MR. BOSTIC: HOW ABOUT WITH THE HCG TEST, FOR EXAMPLE, ARE THERE PATIENT FACTORS THERE THAT COULD CAST DOUBT ON THE ACCURACY OF AN INDIVIDUAL HCG RESULT?

1877

ADAM ROSENDORFF: YES. THERE WAS AN INSTANCE WHERE THE ORIGINAL HCG RESULTS SUGGESTED A MISCARRIAGE AS COMPARED TO A QUEST RESULT, AND THEN A REPEAT THERANOS RESULT WAS MUCH HIGHER, AND IT IS NOT PHYSIOLOGICALLY POSSIBLE TO HAVE THAT, YEAH.

1878

MR. BOSTIC: ON DIRECT DO YOU RECALL REVIEWING SOME INDIVIDUAL INCIDENTS BY REFERENCE TO EXHIBITS AT THIS TRIAL?

1880

MR. BOSTIC: AND DID SOME OF THOSE EXHIBITS INVOLVE TEST RESULTS FROM THERANOS THAT YOU CONCLUDED WERE INACCURATE?

1881

ADAM ROSENDORFF: AFTER THE FACT, YEAH.

1882

MR. BOSTIC: DO YOU RECALL DURING YOUR CROSS-EXAMINATION THERE WAS A DISCUSSION ABOUT ALL OF THE THINGS THAT COULD GO WRONG DURING THE LAB TESTING PROCESS?

1884

MR. BOSTIC: AND THE DIFFERENT WAYS FOR ERROR TO CREEP INTO THE SYSTEM? DO YOU RECALL THAT?

1885

ADAM ROSENDORFF: YOU'RE REFERRING TO THE GOVERNMENT'S DIRECT?

1886

MR. BOSTIC: I'M REFERRING TO YOUR CROSS-EXAMINATION.

1887

ADAM ROSENDORFF: OH, I'M SORRY. YES, I DO RECALL THAT, YEP.

1888

MR. BOSTIC: AND YOU DISCUSSED PREANALYTIC SOURCES OF ERROR, ANALYTIC SOURCES OF ERROR, AND POST ANALYTIC; IS THAT RIGHT?

1890

MR. BOSTIC: AND I'D LIKE TO ASK YOU SOME FOLLOW-UP QUESTIONS ABOUT THAT TOPIC. FIRST, SOME OF THOSE TYPES OF ERROR HAVE NOTHING TO DO WITH THE ACCURACY OF THE TEST METHOD ITSELF; CORRECT?

1892

MR. BOSTIC: AND WHAT ARE SOME OF THOSE SOURCES OF ERROR THAT HAVE NOTHING TO DO WITH THE ACTUAL TEST METHOD?

1893

ADAM ROSENDORFF: ANTICOAGULANT, NOT BEING STANDARDIZED IN THE CTN'S FROM ONE DEVICE TO ANOTHER, CAPILLARY BLOOD SHOOTING VERY RAPIDLY INTO A CTN AND CAUSING HEMOLYSIS DURING BLOOD COLLECTION, CLOTTING OF THE BLOOD SAMPLE IN THE CTN, TEMPERATURE EXCURSIONS DURING TRANSPORTATION FROM ARIZONA TO CALIFORNIA. THOSE ARE SOME OF THE THINGS I CAN THINK OF, YEAH.

1894

MR. BOSTIC: AND DOES LAB TECHNICIAN ERROR GO INTO THAT CATEGORY ALSO?

1895

ADAM ROSENDORFF: THAT WOULD BE ANALYTIC, YEAH.

1896

MR. BOSTIC: AS A LAB DIRECTOR, IF YOU BELIEVE THAT TEMPERATURE PROBLEMS, FOR EXAMPLE, ARE THE SOURCE OF ERRONEOUS RESULTS, HOW DO YOU ADDRESS THAT?

1897

ADAM ROSENDORFF: ONE CAN SIMULATE THE TEMPERATURE VARIATIONS THAT YOU GET DURING TRANSPORTATION EXPERIMENTALLY IN THE LAB BY SUBJECTING A SAMPLE TO, TO SIMILAR -- TO THE EXPECTED TEMPERATURE VARIATIONS.

1898

MR. BOSTIC: AND IF YOU BELIEVE THAT -- IF YOU CONCLUDE THAT THOSE TEMPERATURE FLUCTUATIONS ARE THE SOURCE OF THE PROBLEM, WHAT WOULD YOU DO IN RESPONSE?

1899

ADAM ROSENDORFF: YOU WOULD REACH OUT TO THE COLLECTION SITES TO MAKE SURE THAT AN ICE PACK WAS INCLUDED IN EACH SHIPMENT, FOR INSTANCE, IF IT NEEDS TO BE REFRIGERATED. YOU WOULD DO AN INVESTIGATION AS TO HOW THESE SAMPLES ARE BEING STORED IN ARIZONA, WHETHER THEY'RE BEING IMMEDIATELY REFRIGERATED OR SITTING OUT ON A BENCH TOP, YOU WOULD NEED TO KNOW HOW MUCH TIME HAD ELAPSED BETWEEN COLLECTION AND ARRIVAL IN THE LAB WOULD BE AN IMPORTANT THING TO KNOW.

1900

MR. BOSTIC: AND HOW ABOUT IF SAMPLING MISHANDLING WAS DETERMINED TO BE THE SOURCE OF ERROR, HOW WOULD A LAB DIRECTOR ADDRESS THAT PROBLEM?

1901

ADAM ROSENDORFF: CAN YOU BE MORE SPECIFIC ABOUT SAMPLE MISHANDLING. I'M SORRY.

1902

MR. BOSTIC: SURE. WHAT IF A SAMPLE IS NOT BEING HANDLED GENTLY ENOUGH IN THE LAB, WOULD THAT CAUSE POTENTIAL LAB ERROR IN THE RESULT?

1903

ADAM ROSENDORFF: DEFINITELY IF A SAMPLE IS DROPPED AND CONTAMINATED OR IF IT CROSS-CONTAMINATES OTHER SAMPLES OR -- THE OTHER THING ABOUT PREANALYTIC I FORGOT TO MENTION IS THAT FREQUENTLY PATIENT FINGERS WOULD BE SQUEEZED PRETTY HARD TO GET THE DROP OF BLOOD OUT AND THAT COULD CAUSE BREAKAGE OF RED BLOOD CELLS.

1904

MR. BOSTIC: ON THE TOPIC OF MISHANDLING OR CONTAMINATION?

1906

MR. BOSTIC: IF YOU BELIEVED THAT WAS THE SOURCE OF ERROR IN A LAB THAT YOU WERE SUPERVISING, WHAT STEPS WOULD YOU TAKE TO ADDRESS IT?

1907

ADAM ROSENDORFF: SO YOU DO WHAT IS CALLED A QUALITY EXCEPTION REPORT IF THIS OCCURRED DOCUMENTING EXACTLY WHAT OCCURRED AND WHAT PATIENT SAMPLE IT INVOLVED, YOU DO A ROOT CAUSE ANALYSIS, AND THEN YOU DO PREVENTATIVE AND CORRECTIVE ACTIONS TO FIGURE OUT WHAT CHANGES TO IMPLEMENT TO PREVENT THIS FROM HAPPENING IN THE FUTURE.

1908

MR. BOSTIC: NOW I WANT TO TALK SPECIFICALLY ABOUT YOUR EXPERIENCE AT THERANOS.

1910

MR. BOSTIC: WHEN YOU WERE AT THE COMPANY, DID YOU COME TO CONCLUDE THAT THE COMPANY'S TEST HAD ACCURACY AND RELIABILITY PROBLEMS?

1912

MR. BOSTIC: DID YOU COME TO AN UNDERSTANDING OF WHAT THE SOURCE OF THOSE PROBLEMS WAS, IN OTHER WORDS, AT WHAT STAGE IN THE PROCESS THE ERROR WAS POPPING UP?

1913

ADAM ROSENDORFF: SOME OF THEM WERE PREANALYTIC AND SOME WERE ANALYTIC.

1914

MR. BOSTIC: AND HOW WERE YOU ABLE TO DETERMINE THAT SOME OF THE ERRORS THAT YOU WERE SEEING WERE ANALYTIC.

1915

ADAM ROSENDORFF: UM, SO IN TERMS OF MY EXPERIENCE IN DEALING WITH PATIENTS, IT WOULD BE REPEAT VALUES, VALUES NOT REPEATING FROM ONE SAMPLE TO ANOTHER, NOT REPEATING ON THE SAME SAMPLE.

1916

MR. BOSTIC: AND DOES QUALITY PERFORMANCE HAVE ANYTHING TO DO WITH THE ASSESSMENT OF WHETHER THERE IS ANALYTIC ERROR OCCURRING?

1918

MR. BOSTIC: AND HOW DOES THAT FIT IN?

1919

ADAM ROSENDORFF: IF THERE'S A VERY HIGH RATE OF QC FAILURE, IT COULD RAISE DOUBTS ABOUT THE ACCURACY OF THE ACTUAL ASSAY BECAUSE QC MATERIAL IS STABLE, IT'S NOT SUBJECT TO THE PREANALYTIC ISSUES THAT REAL SAMPLES ARE.

1920

MR. BOSTIC: MS. HOLMES'S LAWYER ASKED YOU IF SHE HAD EVER INSISTED THAT YOU USE AN UNRELIABLE TEST METHOD. DO YOU RECALL THAT QUESTION?

1922

MR. BOSTIC: AND WHAT IS YOUR ANSWER TO THAT QUESTION?

1924

MR. BOSTIC: WHAT WAS YOUR OVERALL VIEW WHEN YOU WERE AT THE COMPANY OF THE RELIABILITY OF THE EDISON ANALYZER?

1925

ADAM ROSENDORFF: INITIALLY I WAS ENTHUSIASTIC ABOUT THE TECHNOLOGY, AND I REALLY TRIED TO MAKE IT WORK, AND I GAVE THE COMPANY A LOT OF BENEFIT OF THE DOUBT, BUT I CAME TO REALLY UNDERSTAND DURING MY TENURE AT THERANOS THAT MANY OF THOSE TESTS WERE INACCURATE.

1926

MR. BOSTIC: AND SPEAKING OF THE EDISON TESTS SPECIFICALLY?

1928

MR. BOSTIC: AND HOW DID YOU COME TO REACH THAT UNDERSTANDING?

1929

ADAM ROSENDORFF: DIFFICULTY GETTING QC TO FALL IN, FREQUENT TECHNICAL MALFUNCTIONS IN THE ACTUAL EQUIPMENT, UM, SINCE WE HAD A VERY INCOMPLETE AND POORLY IMPLEMENTED AAP PROGRAM, I WASN'T ABLE TO COMPREHENSIVELY ASSESS THE ACCURACY OF THOSE TESTS.

1930

MR. BOSTIC: DURING YOUR TIME AT THE COMPANY, DID YOU COME TO UNDERSTAND MS. HOLMES'S POSITION ON THE COMPANY'S USE OF THE EDISON ANALYZER?

1932

MR. BOSTIC: AND WHAT WAS THAT POSITION AS YOU UNDERSTOOD IT?

1933

ADAM ROSENDORFF: SHE WANTED, SHE WANTED TO RAPIDLY EXPAND THE USE OF EDISONS FROM THE TIME OF ROLLOUT THROUGH THE REST OF THE TIME THAT I WAS AT THE COMPANY. AND, IN FACT, MR. BALWANI WANTED TO ALIQUOT BLOOD FROM VACUTAINERS TO CTN'S SO THAT THEY COULD BE RUN ON THE EDISON TECHNOLOGY, SO YES.

1934

MR. BOSTIC: SO, IN OTHER WORDS, THAT WOULD BE USING THE EDISON EVEN TO RUN VEIN DRAW SAMPLES?

1936

MR. BOSTIC: AND THAT UNDERSTANDING THAT MS. HOLMES WANTED THERANOS TO USE THE EDISON, WHAT MADE YOU THINK THAT?

1937

ADAM ROSENDORFF: IT WAS MEETINGS WITH DANIEL AND OTHER PROJECT MANAGERS WHERE THAT WAS THE SENSE THAT I WAS GETTING. IT WASN'T ANYTHING IN PARTICULAR THAT MS. HOLMES HAD SAID TO ME OR ANY EMAIL THAT I COULD POINT TO, YEAH.

1938

MR. BOSTIC: DID YOU EVER HAVE CONVERSATIONS WITH MS. HOLMES ABOUT TAKING AN ASSAY OFF OF A FINGERSTICK AND CEASE USING THE EDISON FOR THAT ASSAY?

1939

ADAM ROSENDORFF: WELL, I REMEMBER SENDING THE EMAIL ABOUT HCG AND SAYING IT SHOULD BE RUN ON -- WITH THE FDA APPROVED TECHNIQUE. I BELIEVE SHE WAS AWARE OF THAT DECISION, YES.

1940

MR. BOSTIC: OKAY. WE'LL TALK ABOUT THAT SPECIFICALLY IN A LITTLE BIT. DID YOU EVER ASK MS. HOLMES WHETHER THERANOS WOULD CONSIDER CEASING USE OF THE EDISON ALTOGETHER?

1942

MR. BOSTIC: WHY NOT?

1943

ADAM ROSENDORFF: THERE WAS TREMENDOUS PRESSURE AT THE COMPANY TO SHOW THAT THIS TECHNOLOGY WAS SUCCESSFUL. IT CAME FROM THE TOP. IT PERMEATED R&D.

1944

MR. BOSTIC: AND WHY DID THAT DISSUADE YOU FROM MAKING THAT SUGGESTION IF THAT'S THE CASE?

1945

ADAM ROSENDORFF: IT WAS CREATING CONFLICT FOR ME. AT VARIOUS POINTS I THOUGHT I MIGHT BE FIRED IF I TOOK TOO STRONG A POSITION ON IT.

1946

MR. BOSTIC: AND WHO AT THERANOS HAD THE AUTHORITY TO FIRE YOU?

1948

MR. BOSTIC: ANYONE ELSE AT THERANOS WHO COULD FIRE YOU?

1949

ADAM ROSENDORFF: WELL, HE WOULD HAVE CONSULTED WITH ELIZABETH ON IT, YEAH.

1950

MR. BOSTIC: ANYONE ELSE BESIDES MR. BALWANI AND MS. HOLMES WHO COULD HAVE FIRED YOU AT THERANOS?

1952

MR. BOSTIC: BESIDES HCG SPECIFICALLY, WERE THERE OTHER INSTANCES AT THERANOS WHERE THE TOPIC OF TAKING AN ASSAY OFF A FINGERSTICK AND MOVING IT BACK TO VENOUS WAS PART OF THE DISCUSSION?

1953

ADAM ROSENDORFF: YES. AS DISCUSSED DURING CROSS FOR THE ISE'S, I SUGGESTED RUNNING THEM NEAT WHICH WOULD BE WITHOUT ESSENTIALLY RUNNING THEM BY A PREDICATE ASSAY, YEAH.

1954

MR. BOSTIC: AND WAS THAT KIND OF DISCUSSION SOMETHING THAT YOU HAD EXPERIENCED ROUTINELY AT YOUR OTHER LAB DIRECTOR POSITIONS?

1956

MR. BOSTIC: IN OTHER WORDS --

1957

ADAM ROSENDORFF: I'M SORRY, I DIDN'T GIVE YOU A CHANCE.

1960

MR. BOSTIC: AND IN OTHER WORDS, A DISCUSSION ABOUT TAKING AN ASSAY OFF OF A PARTICULAR PIECE OF EQUIPMENT BECAUSE IT WASN'T WORKING PROPERLY AND MOVING IT BACK TO SOMETHING MORE ESTABLISHED?

1962

MR. BOSTIC: BY THE TIME YOU LEFT THE COMPANY IN NOVEMBER OF 2014, WHAT WAS YOUR OVERALL IMPRESSION OF THE ACCURACY AND RELIABILITY OF THE THERANOS TESTING PLATFORM?

1963

ADAM ROSENDORFF: I HAD -- I WAS VERY SKEPTICAL.

1964

MR. BOSTIC: AND WAS THAT A FACTOR IN YOUR DECISION TO LEAVE THE COMPANY?

1965

ADAM ROSENDORFF: YES, ABSOLUTELY.

1966

MR. BOSTIC: OKAY. AND WHY IS THAT?

1967

ADAM ROSENDORFF: I FELT THAT IT WAS A QUESTION OF MY INTEGRITY AS A PHYSICIAN NOT TO REMAIN THERE AND TO CONTINUE TO ENDORSING RESULTS THAT I ESSENTIALLY DIDN'T HAVE FAITH IN. I CAME TO UNDERSTAND THAT MANAGEMENT WAS NOT SINCERE IN DIVERTING RESOURCES TO SOLVE ISSUES. OTHER THAN HAVING R&D PUT PATCHES ON THINGS, SUNNY WAS HEAVILY INVOLVED IN ACTUALLY DIRECTING THE CLIA LAB.

1968

MR. BOSTIC: ON CROSS YOU WERE ASKED A QUESTION ABOUT WHETHER OR NOT YOU HAD EVER SEEN AN EMAIL WHERE YOU HAD ASKED FOR RESOURCES AND BEEN TOLD NO?

1970

MR. BOSTIC: DO YOU RECALL THAT TESTIMONY?

1972

MR. BOSTIC: HOW DO YOU SQUARE THAT WITH WHAT YOU JUST SAID THAT YOU FELT MANAGEMENT WASN'T SINCERE ABOUT DEVOTING THOSE RESOURCES?

1973

ADAM ROSENDORFF: SO THE WAY I SAW IT A PROFICIENCY PROGRAM WOULD REQUIRE A MAJOR OPERATIONAL OVERHAUL. AS DR. PANDORI'S EMAIL INDICATED, IT WOULD TIE UP MULTIPLE EDISONS, FOR INSTANCE, AND ESSENTIALLY WOULD BECOME A BUSINESS DECISION REGARDING RESOURCES AND NOT A LAB DIRECTOR DECISION.

1974

MR. BOSTIC: AND IF THERE WEREN'T EMAILS WHERE YOU WERE TOLD NO ON THAT ISSUE, HOW DID YOU KNOW WHAT MANAGEMENT'S POSITION WAS?

1975

ADAM ROSENDORFF: BECAUSE I SAW VARIOUS EFFORTS BY R&D TO DO SOME KIND OF IQP OR AAP, ET CETERA. THEY WEREN'T FOLLOWING A PROTOCOL. THEY WERE INCONSISTENT WITH HOW THEY WERE EXECUTING. FREQUENTLY THEY WEREN'T SHOWING THE DATA TO ME SO I SUSPECTED THAT DIRECTION WAS BEING GIVEN TO THEM ON THIS MATTER.

1976

MR. BOSTIC: AND BESIDES EMAIL, DID YOU EVER DISCUSS THE NEED FOR AAP WITH MS. HOLMES IN PERSON?

1978

MR. BOSTIC: HOW ABOUT MR. BALWANI? DID YOU HAVE DISCUSSIONS WITH HIM ABOUT THE NEED FOR AAP IN PERSON?

1979

ADAM ROSENDORFF: I DON'T BELIEVE SO, NO.

1980

MR. BOSTIC: DO YOU RECALL ON CROSS-EXAMINATION YOU WERE ASKED QUESTIONS ABOUT THE LABORATORY INFORMATION SYSTEM, OR LIS?

1982

MR. BOSTIC: YOU TALKED A FEW MINUTES AGO ABOUT THE WAYS TO IDENTIFY A TEST RESULT IS INACCURATE. DO YOU REMEMBER THAT?

1984

MR. BOSTIC: YOU TALKED ABOUT, FOR EXAMPLE, HOW THERE MIGHT BE INCONSISTENT RESULTS FROM THERANOS LAB TESTS AND LAB TESTS FROM A DIFFERENT LABORATORY?

1986

MR. BOSTIC: AND WOULD THAT INFORMATION BE INCLUDED IN THE THERANOS LABORATORY INFORMATION SYSTEM?

1987

ADAM ROSENDORFF: NO, BUT REPEAT TESTING WOULD BE INCLUDED.

1988

MR. BOSTIC: REPEAT TESTING WITHIN THERANOS?

1990

MR. BOSTIC: TESTING OUTSIDE OF THE COMPANY, THOUGH, FOR EXAMPLE, IF A PATIENT WENT TO THERANOS ONE DAY AND THEN WENT TO SONORA QUEST THE FOLLOWING DAY AND GOT ANOTHER RESULT, WOULD THAT SONORA QUEST RESULT BE LOGGED INTO THE THERANOS LIS?

1991

ADAM ROSENDORFF: NO. IT'S ONLY IF THERANOS SENT OUT A SAMPLE TO A REFERENCE LAB IS THEN THOSE RESULTS FROM THE OUTSIDE REFERENCE LAB WOULD BE RECORDED IN THE LIS.

1992

MR. BOSTIC: ONLY TESTING AT THERANOS OR THROUGH THERANOS ENDS UP IN THAT DATABASE?

1994

MR. BOSTIC: YOU ALSO TALKED ABOUT BEING ABLE TO IDENTIFY INACCURATE TEST RESULTS BASED ON PATIENT FACTORS AND THE WAY A PATIENT PRESENTS?

1996

MR. BOSTIC: AND ARE THOSE PATIENT FACTORS LOGGED IN LIS?

1998

MR. BOSTIC: FOR EXAMPLE, IF A PATIENT RECEIVED AN HCG TEST RESULT THAT SHOWED THAT HER PREGNANCY WAS NONVIABLE AND THEN SHE CARRIED HER BABY TO TERM AND SUCCESSFULLY GAVE BIRTH, WOULD THAT FACT AUTOMATICALLY BE ENTERED IN THE LABORATORY INFORMATION SYSTEM?

2000

MR. BOSTIC: AND, FOR EXAMPLE, IF SOMEONE RECEIVED A POSITIVE TEST SAYING THAT THEY WERE SUFFERING FROM A CERTAIN DISEASE AND THEN THEY LATER RECEIVED A NEGATIVE TEST INDICATING THAT THEY WEREN'T SUFFERING FROM THAT DISEASE FROM ANOTHER LABORATORY, WOULD THAT INFORMATION BE LOGGED IN LABORATORY INFORMATION SYSTEM?

2002

MR. BOSTIC: THE INFORMATION THAT WE'VE BEEN TALKING ABOUT, THE OUTSIDE INFORMATION THAT CAN INDICATE OR REVEAL A TEST RESULT TO BE INACCURATE, HOW WOULD THAT INFORMATION COME TO THERANOS, IF AT ALL?

2003

ADAM ROSENDORFF: THROUGH PHYSICIAN COMPLAINTS OR PHYSICIAN ASSISTANT -- ESSENTIALLY THROUGH A HEALTH CARE PROVIDER COMPLAINT OR QUERY.

2004

MR. BOSTIC: AND AS LAB DIRECTOR, DID YOU RELY ON PHYSICIAN AND PATIENT COMPLAINTS TO ASSESS THE ACCURACY OF TEST RESULTS IN SOME CASES?

2006

MR. BOSTIC: IS THAT A STANDARD PRACTICE AMONG LAB DIRECTORS IN YOUR EXPERIENCE?

2007

MR. WADE: YOUR HONOR, 702.

2008

JUDGE DAVILA: WELL, YOU'RE ASKING ABOUT HIS BUSINESS AND PROFESSIONAL EXPERIENCE?

2009

MR. BOSTIC: I CAN REPHRASE, YOUR HONOR.

2010

JUDGE DAVILA: YES, WHY DON'T YOU.

2011

BY MR. BOSTIC:

2012

MR. BOSTIC: THAT PRACTICE OF RELYING ON DOCTOR OR PATIENT COMPLAINTS TO ASSESS THE ACCURACY OF TESTS, IS THAT SOMETHING THAT YOU'VE DONE THROUGHOUT YOUR CAREER AS A LAB DIRECTOR?

2014

MR. WADE: SAME OBJECTION. MOVE TO STRIKE.

2015

JUDGE DAVILA: OVERRULED.

2016

BY MR. BOSTIC:

2017

MR. BOSTIC: ON CROSS-EXAMINATION YOU WERE SHOWN MANY VALIDATION REPORTS FROM THERANOS. DO YOU RECALL THAT?

2019

MR. BOSTIC: AND I WANT TO MAKE SURE THAT WE'RE CLEAR ON THE RELATIONSHIP ON THE VALIDATION PROCESS AND THE ONGOING QUALITY OF EVALUATION THAT GOES ON AFTER TESTING BEGINS.

2021

MR. BOSTIC: CAN YOU BRIEFLY EXPLAIN THAT DISTINCTION FOR US?

2022

ADAM ROSENDORFF: VALIDATION OCCURS BEFORE PATIENT TESTING IS AUTHORIZED, PERFORMANCE SPECIFICATIONS OF THE ASSAY ARE DEMONSTRATED UNDER IDEAL CONDITIONS, PREANALYTIC FACTORS ARE NOT CONSIDERED FOR THE MOST PART. ONE HAS TO DEMONSTRATE ACCURACY, PRECISION, LINEARITY, ET CETERA, ACCORDING TO THE CFR REGULATIONS. SO THE VALIDATION REPORT IS APPROVED ON THE BASIS OF THE STRENGTH OF THAT DATA ALONE.

2023

MR. BOSTIC: AND ALL OF THAT DATA IS GENERATED BEFORE A SINGLE CLINICAL PATIENT SAMPLE IS RUN?

2025

MR. BOSTIC: HOW DO THINGS CHANGE THEN ONCE VALIDATION IS COMPLETED AND PATIENT TESTING ACTUAL BEGINS? HOW IS QUALITY MONITORED FROM THAT POINT ON?

2026

ADAM ROSENDORFF: WELL, NOW YOU HAVE QC DATA, YOU HAVE RATES OF TEST RESULTS THAT ARE OUTSIDE OF THE REFERENCE RANGE THAT I WOULD REVIEW FREQUENTLY AT THERANOS, YOU HAVE PHYSICIAN QUERIES AND COMPLAINTS.

2027

MR. BOSTIC: WHEN A TEST COMPLETES VALIDATION AND IT QUALIFIES FOR USE ON ACTUAL PATIENTS, DOES THAT SETTLE THE RECORD FOREVER AS TO ITS ACCURACY AND RELIABILITY?

2028

ADAM ROSENDORFF: NO, IT DOES NOT.

2029

MR. BOSTIC: AND WHY NOT?

2030

ADAM ROSENDORFF: BECAUSE OF PREANALYTIC ISSUES THAT ARE NOT CAPTURED IN THE VALIDATION, VARIATION BETWEEN INSTRUMENTS AND REAGENTS THAT ARE NOT CAPTURED IN THE VALIDATION, THERE COULD BE SERIOUS DIFFERENCES IN THE PERFORMANCE OF DIFFERENT INSTRUCTIONS, DIFFERENT REAGENTS, KITS, INTERFERING SUBSTANCES, THAT'S ANOTHER PREANALYTIC CONSIDERATION, ET CETERA.

2031

MR. BOSTIC: AND ALL OF THOSE FACTORS ARE FACTORS THAT COULD ADVERSELY AFFECT THE ACCURACY OF THE TEST?

2033

MR. BOSTIC: AND THOSE FACTORS AREN'T 100 PERCENT ACCOUNTED FOR DURING THE VALIDATION PROCESS?

2035

MR. BOSTIC: AT THERANOS --

2036

ADAM ROSENDORFF: ALSO THE ASSUMPTION DURING THE VALIDATION IS THAT VENOUS BLOOD WOULD BEHAVE IDENTICALLY TO CAPILLARY BLOOD. SO THE MAJORITY OF VALIDATION WAS DONE ON VENOUS BLOOD AND ONLY THE REFERENCE RANGE VERIFICATION WAS DONE USING CAPILLARY BLOOD.

2037

MR. BOSTIC: AND CAN YOU EXPLAIN THAT, WHAT STEPS OF THE VALIDATION PROCESS WERE DONE RELYING SOLELY ON BLOOD FROM THE VEIN INSTEAD OF THE FINGERSTICK?

2038

ADAM ROSENDORFF: REPRODUCIBILITY, ACCURACY, LINEARITY, UPPER LIMIT OF QUANTITATION, LOWER LIMIT OF QUANTITATION, INTERFERING SUBSTANCES.

2039

MR. BOSTIC: THOSE ARE DONE ON VEIN BLOOD ONLY?

2041

MR. BOSTIC: AND WHAT STEPS IN VALIDATION INCLUDED FINGERSTICK SAMPLES?

2042

ADAM ROSENDORFF: THE REFERENCE RANGE VERIFICATION.

2043

MR. BOSTIC: AND HOW DID THAT WORK?

2044

ADAM ROSENDORFF: ONE RUNS A NUMBER OF CLINICAL SAMPLES -- ONE RUNS OLD SAMPLES IN THE VALIDATION TO COME UP WITH A PROVISIONAL REFERENCE RANGE AND THEN YOU RUN I THINK IT WAS 20 FINGERSTICK SAMPLES AND YOU ENSURE THAT ALL OF THEM FALL WITHIN THAT REFERENCE RANGE FOLLOWING CLSI GUIDANCE. I'M SORRY, I HAVE TO BREAK FOR A FEW MINUTES FOR THE RESTROOM.

2045

JUDGE DAVILA: LET'S TAKE ABOUT SEVEN MINUTES. LADIES AND GENTLEMEN, LET'S TAKE ABOUT A SEVEN MINUTE BREAK.

2046

(JURY OUT AT 2:17 P.M.)

2047

JUDGE DAVILA: THE JURY AND THE WITNESS JUST LEFT THE COURTROOM. I JUST WANT TO ASK, AND I'M NOT PRESSURING ANYONE, BUT DO WE ANTICIPATE THE GOVERNMENT WILL FINISH THIS WITNESS TODAY?

2048

MR. BOSTIC: THE COURT WOULD LIKE TO STOP AT 3:00 P.M.?

2049

JUDGE DAVILA: THAT'S WHAT I THOUGHT WE WOULD DO, BUT I'M HAPPY TO RECEIVE YOUR BEST ESTIMATES. I COULD ASK THEM TO STAY UNTIL 4:00 O'CLOCK IF YOU THINK THAT'S PRODUCTIVE.

2050

MR. BOSTIC: I THINK IF WE STAY UNTIL 4:00 IT'S LIKELY WE WILL COMPLETE THE REDIRECT BUT NOT LEAVE MUCH TIME FOR RECROSS.

2051

JUDGE DAVILA: WELL, YOU WON'T HAVE ANYTHING, MR. WADE?

2052

MR. WADE: TO BE DETERMINED. IT SOUNDS LIKE WE WON'T GET THE WITNESS IN GIVEN -- WE WOULD HAVE ANOTHER HOUR AND A HALF. I WOULD ANTICIPATE AT SOME POINT HAVING SOME RECROSS.

2053

JUDGE DAVILA: SURE. WELL, WE'LL HAVE HIM BACK TOMORROW, I THINK, AND THEN FINISH HIM TOMORROW MORNING MOST LIKELY. AND YOU'LL HAVE ANOTHER WITNESS AVAILABLE I TAKE IT?

2054

MR. BOSTIC: YES, YOUR HONOR. THAT'S OUR GOAL AND EXPECTATION.

2055

JUDGE DAVILA: OKAY. LET'S DO THAT. THANK YOU.

2056

(RECESS FROM 2:18 P.M. UNTIL 2:25 P.M.)

2057

(JURY IN AT 2:25 P.M.)

2058

JUDGE DAVILA: ALL RIGHT. THANK YOU. WE'RE BACK ON THE RECORD. THANK YOU. PLEASE BE SEATED. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. THE DOCTOR IS ON THE STAND. MR. BOSTIC.

2059

MR. BOSTIC: THANK YOU, YOUR HONOR.

2060

MR. BOSTIC: DR. ROSENDORFF, BEFORE THE BREAK WE WERE TALKING ABOUT VALIDATION REPORTS. DO YOU RECALL THAT?

2062

MR. BOSTIC: ON CROSS-EXAMINATION YOU WERE SHOWN A NUMBER OF VALIDATION REPORTS THAT BORE YOUR SIGNATURE; CORRECT?

2064

MR. BOSTIC: CAN YOU EXPLAIN FOR THE JURY ONE MORE TIME WHAT SIGNIFICANCE IT HAS WHEN A LABORATORY DIRECTOR SIGNS A VALIDATION REPORT?

2065

ADAM ROSENDORFF: SO THE VALIDATION REPORT IS SIGNED ON THE BASIS OF STUDIES THAT ARE PERFORMED IN THE LABORATORY THAT SHOW EVIDENCE THAT THE TEST IS ACCURATE, REPRODUCIBLE, ET CETERA, AND FULFILL THE PERFORMANCE SPECIFICATIONS AS OUTLINED IN THE CLIA REGULATIONS.

2066

MR. BOSTIC: AND I THINK YOU STARTED TO ANSWER WHAT WAS GOING TO BE MY NEXT QUESTION ALSO WHICH IS, ARE THE STANDARDS FOR VALIDATION SOMETHING THAT EACH LABORATORY DIRECTOR KIND OF EYEBALLS OR RELIES ON THEIR GUT FOR OR ARE THERE A SET OF OBJECTIVE STANDARDS?

2067

ADAM ROSENDORFF: NO. THEY'RE OUTLINED IN THE CLIA REGULATIONS.

2069

ADAM ROSENDORFF: THAT'S A MINIMUM.

2070

MR. BOSTIC: AND IF A GIVEN ASSAY MEETS THOSE STANDARDS, IS THERE ANY REASON OR WOULD THERE BE ANY REASON NOT TO SIGN A VALIDATION REPORT FOR THAT ASSAY?

2072

MR. BOSTIC: WHEN YOU WERE AT THERANOS, FOR EACH OF THE VALIDATION REPORTS THAT YOU SIGNED, HAD THE ASSAY PERFORMED WELL ENOUGH IN YOUR VIEW TO MEET THE STANDARDS FOR VALIDATION?

2074

MR. BOSTIC: AND THE VALIDATION REQUIREMENTS, DO THEY HAVE ANYTHING TO DO WITH TESTING ACCURACY?

2076

MR. BOSTIC: AND ARE THEY THE END OF THE QUESTION WHEN IT COMES TO ASSAY ACCURACY?

2078

MR. BOSTIC: FOR THE VALIDATION REPORTS THAT YOU SIGNED AND THE ASSAYS THAT MOVED INTO THE CLINICAL LAB AT THERANOS --

2080

MR. BOSTIC: -- IN EVERY CASE DID THEY CONTINUE TO PERFORM AS WELL IN THE CLINICAL LAB AS THEY HAD IN VALIDATION?

2081

ADAM ROSENDORFF: NO, NOT AT ALL.

2082

MR. BOSTIC: EXPLAIN THAT.

2083

ADAM ROSENDORFF: PARTICULARLY WITH -- SO IN THE CASE OF THE EDISON TESTS THE -- MY ASSESSMENT WAS THAT THE ACCURACY AND REPRODUCIBILITY WERE NOT ANYWHERE CLOSE TO WHAT WAS SHOWN TO ME IN THE VALIDATION REPORTS.

2084

MR. BOSTIC: IN WHAT WAY SPECIFICALLY?

2085

ADAM ROSENDORFF: REPEAT TESTING ON SAMPLES GIVING DIFFERENT RESULTS, SAMPLES RUN ON DIFFERENT INSTRUMENTS GIVING DIFFERENT RESULTS, DISCREPANT RESULTS BETWEEN OURSELVES AND OUTSIDE LABORATORIES. SOMETIMES IT'S A REASONABLE APPROACH IN VALIDATION TO ACTUALLY SPLIT SAMPLES AND SEND OUT SOME OF THE SAMPLE TO AN OUTSIDE LAB SO THAT YOU CAN COMPARE YOUR RESULTS TO AN OUTSIDE LABORATORY. A SIMILAR THING I WAS OBSERVING AS A PHYSICIAN, AS A LABORATORY DIRECTOR, WAS THAT THE OUTSIDE RESULTS WERE NOT MATCHING OURS.

2086

MR. BOSTIC: AND ALL OF THE FACTORS THAT YOU JUST LISTED, WERE ANY OF THOSE FACTORS APPARENT DURING THE VALIDATION STAGE FOR THESE ASSAYS?

2088

MR. BOSTIC: DO YOU KNOW WHETHER MS. HOLMES WAS GENERALLY FAMILIAR WITH THE VALIDATION REPORTS?

2089

ADAM ROSENDORFF: YES, SHE WAS FAMILIAR WITH THEM.

2090

MR. BOSTIC: AND WHAT IS YOUR BASIS FOR SAYING THAT?

2091

ADAM ROSENDORFF: SHE -- AS WE SAW DURING THE TRIAL, SHE HAD EMAILED SUREKHA TO ASK HOW MANY OF THE TESTS HAD BEEN VALIDATED. IT WAS GENERALLY SOMETHING THAT SHE KEPT TABS ON, YEAH.

2092

MR. BOSTIC: DURING YOUR TIME AS LABORATORY DIRECTOR AT THERANOS, DID YOU HAVE CONVERSATIONS WITH MS. HOLMES ABOUT ACCURACY AND RELIABILITY PROBLEMS OF THE ASSAYS?

2094

MR. BOSTIC: AND DURING ANY OF THOSE CONVERSATIONS DID MS. HOLMES CITE THE VALIDATION REPORTS BACK TO YOU?

2096

MR. BOSTIC: IN ANY OF THOSE CONVERSATIONS DID SHE SAY, NO, WE CAN DISMISS THESE PROBLEMS THAT WE'RE SEEING NOW BECAUSE WE SAW GOOD PERFORMANCE AT THE VALIDATION STAGE?

2097

ADAM ROSENDORFF: NO, SHE DID NOT.

2098

MR. BOSTIC: DID MS. HOLMES EVER ASK YOU ABOUT THE INCONSISTENCY BETWEEN GOOD PERFORMANCE IN VALIDATION AND POOR PERFORMANCE IN THE LAB?

2099

ADAM ROSENDORFF: NO, BUT I JUST -- DANIEL AND I DISCUSSED IT.

2100

MR. BOSTIC: AND WHAT DID YOU TELL DANIEL YOUNG DURING THOSE CONVERSATIONS?

2101

ADAM ROSENDORFF: I TOLD HIM THAT THE ASSAY PERFORMANCE WAS NOT CONSISTENT WITH THE VALIDATION ON THE EDISONS, AND HE AGREED.

2102

MR. BOSTIC: SO THERE WAS NO DISPUTE AS TO THAT?

2104

MR. BOSTIC: AS TIME WENT BY AT THERANOS, IS IT FAIR TO SAY THAT YOU SAW MORE AND MORE PROBLEMS WITH ACCURACY AND RELIABILITY?

2106

MR. BOSTIC: ON CROSS-EXAMINATION MR. WADE ASKED YOU ABOUT VALIDATION REPORTS THAT YOU SIGNED OVER A SERIES OF MONTHS DURING YOUR TIME AT THE COMPANY. DO YOU RECALL THAT?

2108

MR. BOSTIC: AND WHY DID YOU CONTINUE TO SIGN VALIDATION REPORTS FOR THE EDISON, FOR EXAMPLE, AFTER SEEING THE ACCURACY AND RELIABILITY PROBLEMS THAT WE HAVE BEEN TALKING ABOUT?

2109

ADAM ROSENDORFF: I WAS ASSESSING THE PERFORMANCE OF THE ASSAY FOR INDIVIDUAL ANALYTES BASED ON THE DATA IN THE VALIDATION REPORT.

2110

MR. BOSTIC: WHEN A VALIDATION REPORT WAS PRESENTED TO YOU FOR SIGNATURE, WOULD THAT BE FOR AN ASSAY THAT WAS ALREADY BEING RUN IN THE CLINICAL LAB?

2112

MR. BOSTIC: AND DOES THAT MEAN THAT THERE WERE KINDS OF INFORMATION THAT YOU WOULDN'T HAVE ABOUT THAT ASSAY THAT YOU WOULD HAVE IF IT HAD BEEN RUN ON ACTUAL PATIENT SAMPLES?

2114

MR. BOSTIC: AND WHAT KINDS OF INFORMATION ARE WE TALKING ABOUT THERE?

2115

ADAM ROSENDORFF: AS I MENTIONED, INCONSISTENCIES WITH THE MEDICAL PICTURE OF THE PATIENT, OUTSIDE LAB RESULTS THAT DON'T MATCH UP, REPEAT TESTING ON, YOU KNOW, CLINICAL SAMPLES, PREANALYTIC ISSUES SUCH AS DURING COLLECTION TRANSPORTATION THAT WE'VE SPOKEN ABOUT, A HOST OF ISSUES THAT WOULD NOT BE CAPTURED IN THE VALIDATION REPORT.

2116

MR. BOSTIC: AS A LAB DIRECTOR, WOULD YOU EVER REFUSE TO SIGN A VALIDATION REPORT FOR ONE ASSAY BASED ON THE PERFORMANCE THAT YOU HAD SEEN OF ANOTHER ASSAY?

2118

MR. BOSTIC: WHY NOT?

2119

ADAM ROSENDORFF: I WAS ASSESSING EACH VALIDATION ON ITS OWN MERITS BASED ON THE DATA IN THE VALIDATION. THERE WOULD BE NO, THERE WOULD BE NO RIGOROUS SCIENTIFIC WAY OF REFUSING TO SIGN A VALIDATION OTHER THAN WHAT WAS PRESENTED IN TERMS OF DATA IN THE VALIDATION REPORT.

2120

MR. BOSTIC: ALL OF THE VALIDATION WORK THAT YOU WITNESSED AT THERANOS, THAT YOU WERE INVOLVED IN, I'M CURIOUS ABOUT HOW YOU VIEWED THAT WORK AND THOSE DOCUMENTS AT THE TIME THAT YOU DECIDED TO LEAVE THE COMPANY? HOW DID THAT FACTOR INTO YOUR DECISION?

2121

ADAM ROSENDORFF: I STARTED TO LOSE FAITH THAT THE VALIDATION DATA ACTUALLY REFLECTED WHAT HAD BEEN DONE IN R&D DURING THEIR VALIDATION WORK.

2122

MR. BOSTIC: I'D LIKE TO TALK SOME MORE ABOUT HCG.

2124

MR. BOSTIC: DO YOU RECALL SOME QUESTIONS DURING DIRECT ABOUT HCG?

2126

MR. BOSTIC: AND ON CROSS-EXAMINATION YOU WERE ASKED SOME QUESTIONS ABOUT THE HCG TEST?

2128

MR. BOSTIC: IF WE CAN PUT UP THE EXHIBIT 4147, PLEASE, WHICH HAS BEEN ADMITTED. DR. ROSENDORFF, DO YOU SEE ON THE SCREEN IN FRONT OF YOU AN EMAIL FROM YOU ON MAY 3RD, 2014?

2130

MR. BOSTIC: AND YOU RECALL DISCUSSING THIS EMAIL ON DIRECT AND CROSS; CORRECT?

2132

MR. BOSTIC: LET'S LOOK AT THE TEXT BELOW THAT BOX. DR. ROSENDORFF, THIS IS THE EMAIL WHERE YOU TESTIFIED THAT YOU DECIDED TO HALT ALL HCG TESTING ON THE EDISON. DO YOU RECALL THAT?

2134

MR. BOSTIC: AND THERE WAS SOME DISCUSSION WITH MR. WADE ABOUT THE EVENTS THAT FOLLOWED THIS AND WHAT HAPPENED NEXT. DO YOU RECALL THAT?

2136

MR. BOSTIC: I'D LIKE TO SHOW YOU WHAT WE'LL MARK AS EXHIBIT 5419. MAY I APPROACH, YOUR HONOR?

2138

BY MR. BOSTIC:

2139

MR. BOSTIC: (HANDING.)

2141

MR. BOSTIC: DR. ROSENDORFF, I DON'T HAVE BINDERS FOR YOU TODAY. I KNOW YOU'LL BE DISAPPOINTED. DO YOU HAVE EXHIBIT 5419 IN FRONT OF YOU?

2142

ADAM ROSENDORFF: THE ONE YOU JUST HANDED ME?

2145

MR. BOSTIC: IS IT AN EMAIL DATED JUNE 5TH, 2014?

2147

MR. BOSTIC: AND IF YOU TURN TO PAGE 2 OF THE EXHIBIT, IS IT A CONTINUATION OF THE EMAIL CHAIN THAT WE WERE JUST LOOKING AT?

2149

MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 5419.

2150

MR. WADE: NO OBJECTION, YOUR HONOR.

2151

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

2152

(GOVERNMENT'S EXHIBIT 5419 WAS RECEIVED IN EVIDENCE.)

2153

BY MR. BOSTIC:

2154

MR. BOSTIC: SO IF WE CAN FLIP BRIEFLY TO PAGE 2. DR. ROSENDORFF, DO YOU SEE YOUR EMAIL ON MAY 30TH HALTING ALL TESTING ON THE EDISON; CORRECT?

2156

MR. BOSTIC: AND YOU SAY IT'S TO BE RUN ON THE IMMULITE; IS THAT RIGHT?

2158

MR. BOSTIC: AND THE IMMULITE WAS A NON-THERANOS THIRD PARTY DEVICE?

2160

MR. BOSTIC: AND LET'S GO BACK TO PAGE 1 AND MOVE UP THE CHAIN. AT THE BOTTOM OF PAGE 1 -- LET'S ZOOM IN ON THE BOTTOM COUPLE OF MESSAGES THERE. DO YOU SEE AT THE VERY BOTTOM THERE'S AN EMAIL FROM HODA ALAMDAR ASKING YOU WHETHER SHE CAN RELEASE RESULTS FOR A GIVEN PATIENT WHO HAD HCG TESTING ON EDISON?

2162

MR. BOSTIC: AND DO YOU SEE ABOVE THAT THERE'S AN EMAIL FROM DANIEL YOUNG TO SUNNY BALWANI AND CHINMAY PANGARKAR WHERE DANIEL YOUNG SAYS, "I WAS JUST SPEAKING WITH ADAM ABOUT THIS. WE WILL HOLD THE RESULT UNTIL THE STUDY WE ARE RUNNING TODAY ON THE EDISON ASSAY IS DONE. DATA SHOULD BE READY TONIGHT TO REVIEW." DO YOU SEE THAT?

2164

MR. BOSTIC: AND DO YOU RECALL THERE WAS A STUDY DONE AROUND THIS TIME TO TRY AND RESOLVE THE ISSUES AROUND THE HCG AND EDISON?

2165

ADAM ROSENDORFF: I DO NOT RECALL INDEPENDENTLY, NO.

2166

MR. BOSTIC: LET'S ZOOM IN ON THE TOP HALF OF PAGE 1. DO YOU SEE AN EMAIL FROM CHINMAY PANGARKAR AT THE BOTTOM OF THE COLLECTION THERE, "WE ARE DOING A STUDY TO ESTABLISH THE CUT-OFF BETWEEN OORL AND INVALID RESULTS."

2168

MR. BOSTIC: AND THE SECOND LINE THERE SAYS, "ALSO, AS PART OF THIS, WE WILL BE RE-DOING IQP FOR HCG." DO YOU SEE THAT?

2170

MR. BOSTIC: AND WHAT WAS IQP?

2171

ADAM ROSENDORFF: I DON'T KNOW ALL OF THE -- I BELIEVE IQP IS AN INDIVIDUALIZED QUALITY CONTROL PROGRAM THAT IS -- IT'S A CAP. IT'S AN ALTERNATIVE METHOD OF ASSESSING PROFICIENCY OR QUALITY THAT CAP ALLOWS, AND THAT'S ABOUT ALL I KNOW ABOUT IT NOW.

2172

MR. BOSTIC: AND WAS THE GOAL OF THIS ACTIVITY TO TRY TO FIGURE OUT WHAT WAS GOING WRONG WITH HCG?

2174

MR. BOSTIC: AND WAS THIS ALL CONSISTENT WITH YOUR INITIAL EMAIL TO HALT EDISON TESTING ON HCG FOR THE TIME BEING?

2175

ADAM ROSENDORFF: WELL, HODA'S EMAIL SAYS I SEE SOME RESULTS IN LIS FOR HCG. WHY WOULD THERE BE RESULTS IN THE LIS FOR HCG FOR THE EDISON IF I'D INSTRUCTED THE LABORATORY TO HALT TESTING ON THE EDISON? THAT'S WHAT I DON'T UNDERSTAND.

2176

MR. BOSTIC: DO YOU SEE ITEM NUMBER 2 IN YOUR THREE POINT LIST?

2178

MR. BOSTIC: AND IT READS HOLD ALL EDISON CTN RESULTS, DO NOT RELEASE?

2180

MR. BOSTIC: AND COULD THOSE HAVE BEEN RESULTS THAT HAD BEEN RUN PREVIOUSLY BUT NOT YET RELEASED?

2181

ADAM ROSENDORFF: I DO NOT KNOW.

2182

MR. BOSTIC: I'D LIKE TO SHOW YOU NOW WHAT WE HAVE MARKED AS EXHIBIT 5418. MAY I APPROACH, YOUR HONOR?

2184

BY MR. BOSTIC:

2185

MR. BOSTIC: (HANDING.) DOCTOR, DO YOU NOW HAVE IN FRONT OF YOU EXHIBIT 5418?

2186

ADAM ROSENDORFF: YES, I HAVE THE PAPER YOU JUST HANDED TO ME.

2187

MR. BOSTIC: AND IS THIS ANOTHER EMAIL IN THE SAME CHAIN REGARDING HCG TESTING?

2189

MR. BOSTIC: BETWEEN INDIVIDUALS AT EMPLOYEES AT THERANOS INCLUDING AT THE TOP OF THE MESSAGE SUNNY BALWANI AND ELIZABETH HOLMES?

2191

MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 5418.

2192

MR. WADE: NO OBJECTION.

2193

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

2194

(GOVERNMENT'S EXHIBIT 5418 WAS RECEIVED IN EVIDENCE.)

2195

BY MR. BOSTIC:

2196

MR. BOSTIC: AND IF WE CAN ZOOM IN ON THE BOTTOM HALF OF PAGE 1. FROM THERE DOWN IS PERFECT. THANKS. DR. ROSENDORFF, DO YOU SEE THIS IS THE SAME EMAIL CHAIN THAT WE WERE JUST LOOKING AT?

2198

MR. BOSTIC: AND LET'S ZOOM IN ON THE TOP HALF OF THE PAGE NOW. DO YOU SEE AN EMAIL FROM DANIEL YOUNG TO SUNNY BALWANI AND CHINMAY PANGARKAR ON JUNE 4TH, 2014, AT 5:12 P.M.?

2200

MR. BOSTIC: AND THIS IS A FEW DAYS AFTER YOUR EMAIL ORDERING THAT HCG TESTING ON EDISON BE STOPPED; CORRECT?

2202

MR. BOSTIC: DANIEL YOUNG IN HIS EMAIL -- FIRST OF ALL, YOU WERE NOT INCLUDED ON THAT EMAIL; RIGHT?

2204

MR. BOSTIC: AND HE WRITES TO CHINMAY PANGARKAR AND SUNNY BALWANI AND SAYS, "BY THE WAY, WE NEVER SWITCHED TO IMMULITE IN LIS -- IT WAS NOT CLEAR TO ME THAT THIS DECISION WAS MADE. "WE ARE LOOKING AT THE TIMING OF SWITCHING TO IMMULITE NOW AS A FALLBACK DEPENDING ON THE STUDY RESULTS TODAY." DO YOU SEE THAT?

2206

MR. BOSTIC: AND WHAT WOULD IT MEAN TO SWITCH TO IMMULITE IN LIS?

2207

ADAM ROSENDORFF: IT WOULD MEAN THAT IT WOULD NOT BE RECORDED IN THE LIS THAT THE IMMULITE WAS ACTIVE AS A METHOD FOR DOING THE HCG TEST. THAT REFERENCE RANGES WOULD BE THE IMMULITE REFERENCE RANGES. THE LIS WOULD BE ACCURATELY RECORDING WHAT METHOD WAS USED AND WHAT THE SAMPLE TYPE WAS. LIS IS THE SYSTEM OF RECORD FOR WHAT IS OCCURRING IN THE CLINICAL LABORATORY.

2208

MR. BOSTIC: AND DOES LIS GUIDE THE WORKFLOW IN THE CLINICAL LABORATORY?

2209

ADAM ROSENDORFF: CAN YOU EXPLAIN A BIT? I'M SORRY.

2210

MR. BOSTIC: LET ME ASK A MORE SPECIFIC QUESTION. IS MAKING THIS CHANGE IN LIS A NECESSARY STEP TO IMPLEMENTING YOUR DIRECTION --

2212

MR. BOSTIC: -- TO MOVE HCG FROM EDISON ONTO THE IMMULITE?

2214

MR. BOSTIC: SITTING HERE TODAY, ARE YOU SURPRISED TO READ THAT ON JUNE 4TH, 2014, DAYS AFTER YOUR EMAIL, DANIEL YOUNG WAS EMAILING SUNNY BALWANI SAYING THAT IT WAS NOT CLEAR THAT THE DECISION TO TAKE HCG OFF OF EDISON HAD ACTUALLY HAPPENED?

2215

ADAM ROSENDORFF: YES, I AM SURPRISED.

2216

MR. BOSTIC: IN YOUR VIEW WAS IT CLEAR THAT THAT DECISION HAD BEEN MADE?

2217

ADAM ROSENDORFF: YES. IN FACT, DANIEL MAY HAVE BEEN ON THE CLS DISTRIBUTION LIST. I'D HAVE TO CHECK.

2218

MR. BOSTIC: IN ANY CASE, DANIEL YOUNG IS RESPONDING TO THIS EMAIL CHAIN THAT INCLUDES YOURS; CORRECT?

2219

ADAM ROSENDORFF: SORRY, CAN YOU SAY AGAIN.

2220

MR. BOSTIC: THE EMAIL IN FRONT OF YOU HAS DANIEL YOUNG RESPONDING IN THE EMAIL CHAIN THAT INCLUDES YOUR INITIAL INSTRUCTIONS; IS THAT RIGHT?

2222

MR. BOSTIC: THERE WAS SOME DISCUSSION DURING CROSS ABOUT THE ROLE OF THE LABORATORY DIRECTOR. DO YOU RECALL THAT?

2224

MR. BOSTIC: AND THE AUTHORITY OF THE LABORATORY DIRECTOR WITHIN THE LAB?

2226

MR. BOSTIC: THIS KIND OF DECISION, THE DECISION TO CHANGE TESTING METHODS FOR A GIVEN ASSAY BASED ON ACCURACY PROBLEMS, WHOSE DECISION SHOULD THAT HAVE BEEN TO MAKE AT A CLINICAL LAB?

2227

ADAM ROSENDORFF: THE LABORATORY DIRECTOR.

2228

MR. BOSTIC: AND DID YOU FEEL AT THE TIME THAT THERE WAS ANY LACK OF CLARITY AROUND THIS DECISION?

2230

MR. BOSTIC: YOU SEE AT THE TOP OF THE PAGE THAT THAT EMAIL WAS FORWARDED BY SUNNY BALWANI TO ELIZABETH HOLMES; CORRECT?

2232

MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 13875. I BELIEVE THAT'S IN EVIDENCE. LOOK AT THE BOTTOM OF PAGE 1. SO WE'RE STILL ON THAT SAME DAY, DR. ROSENDORFF, JUNE 4TH, 2014. DO YOU SEE THAT?

2234

MR. BOSTIC: AND STILL DISCUSSING HCG WITH OTHERS AT THERANOS?

2236

MR. BOSTIC: AND YOUR EMAIL SAYS THAT YOU HAD DISCUSSED THE PLAN FOR HCG WITH DANIEL AND CHINMAY; CORRECT?

2238

MR. BOSTIC: UNDER NUMBER 2 YOU WRITE THAT THAT STEP INCLUDES ASSUMING THAT THE INCONSISTENCIES WITH FRIDAY'S PATIENT HCG VALUES WAS DUE TO SAMPLE MISHANDLING, AND THEN YOU PUT A QUESTION MARK. DO YOU SEE THAT?

2240

MR. BOSTIC: HAD THAT BEEN ESTABLISHED AT THAT POINT THAT THE HCG VALUES WAS DUE TO SAMPLE MISHANDLING?

2242

MR. BOSTIC: AND WHY WERE YOU WRITING THIS ASSUMPTION IN THIS EMAIL IF YOU RECALL?

2243

ADAM ROSENDORFF: I DON'T RECALL.

2244

MR. BOSTIC: UNDERNEATH GOING FORWARD IN YOUR EMAIL. DO YOU SEE THAT SECTION?

2246

MR. BOSTIC: ITEM NUMBER 1 SAYS, "CHANGE HCG TO VACUTAINER (SST OR GOLD-TOP), AND RUN ON IMMULITE." DO YOU SEE THAT?

2248

MR. BOSTIC: AND AS OF JUNE 4TH, 2014, DAYS AFTER YOUR MAY 30TH EMAIL, WAS YOUR POSITION STILL THAT HCG SHOULD BE RUN ON THE THIRD PARTY DEVICE AND NOT THE THERANOS DEVICE?

2250

MR. BOSTIC: LET'S GO TO PAGE 2 AND ZOOM IN ON THE TOP MESSAGE THERE. DO YOU SEE ITEM 3 IN YOUR LIST CONTINUES, "RESUME CTN HCG WHEN WE HAVE RESOLVED THESE ISSUES."

2252

MR. BOSTIC: FAIR TO SAY THAT ON JUNE 4TH AT THE TIME YOU WROTE THIS EMAIL THAT THOSE ISSUES WERE NOT YET RESOLVED?

2254

MR. BOSTIC: AND REMIND US WHAT THE CTN IS?

2255

ADAM ROSENDORFF: CAPILLARY TUBE AND NANOTAINER. IT'S THE COLLECTION DEVICE FOR THERANOS TESTS.

2256

MR. BOSTIC: LET'S GO BACK TO PAGE 1 OF THIS EMAIL AND ZOOM IN ON THE MIDDLE MESSAGE ON THE PAGE FROM DANIEL YOUNG. OKAY. DR. ROSENDORFF, DO YOU SEE MORE REFERENCE HERE TO REPEATING THE IQP STUDY?

2258

MR. BOSTIC: AND HE SAYS, "AT THIS TIME WE WILL BE READY TO SWITCH TO IMMULITE TOMORROW NIGHT." DO YOU SEE THAT?

2260

MR. BOSTIC: AND DOES THAT MEAN THAT THE SWITCH TO IMMULITE STILL HAD NOT HAPPENED?

2261

ADAM ROSENDORFF: THAT'S HOW I UNDERSTAND THIS EMAIL, YES.

2262

MR. BOSTIC: AND THERE'S A NOTE BELOW THAT THAT SAYS, "IF WE NEED TO COLLECT VACUTAINERS TOMORROW, WE WOULD NEED TO SEND SPECIAL INSTRUCTIONS TO THE PSC'S." DO YOU SEE THAT?

2264

MR. BOSTIC: AND DO YOU HAVE AN UNDERSTANDING AS TO WHY THAT WOULD BE NECESSARY?

2265

ADAM ROSENDORFF: THE SERVICE CENTERS THAT DO THE BLOOD COLLECTION WOULD NEED TO KNOW WHAT KIND OF SAMPLE WAS REQUIRED FOR THIS TEST. HOWEVER, THERE WAS ALSO A PIECE OF SOFTWARE THAT WAS AVAILABLE TO THE PHLEBOTOMIST AT THE PSC'S THAT WOULD TELL THEM EXACTLY -- OR CTN WAS REQUIRED FOR ANY GIVEN TEST.

2266

MR. BOSTIC: AND DOES THIS MEAN THAT IN ORDER TO FOLLOW THROUGH WITH THE CHANGE TO THE THIRD PARTY DEVICE, THE PSC'S WOULD NEED TO RECEIVE THESE INSTRUCTIONS?

2268

MR. BOSTIC: DANIEL YOUNG'S EMAIL SAYS, "RIGHT NOW WE ARE NOT PLANNING ON DOING THIS." DO YOU SEE THAT?

2270

MR. BOSTIC: AND WHAT DOES THAT TELL YOU ABOUT THE LIKELIHOOD OR WHETHER EVENTS WERE IN MOTION ALREADY TO ACTUALLY CARRY OUT THIS CHANGE?

2271

ADAM ROSENDORFF: IT INDICATES THAT HE'S NOT WILLING TO PERFORM THE STEPS TO MOVE THE ASSAY ONTO THE IMMULITE. I DON'T KNOW WHO HE MEANS BY "WE."

2272

MR. BOSTIC: WHO WOULD BE RESPONSIBLE FOR SENDING THOSE INSTRUCTIONS TO THE PSC'S?

2273

ADAM ROSENDORFF: I BELIEVE MAX FOSQUE WAS IN CHARGE OF COORDINATION WITH THE PSC'S.

2274

MR. BOSTIC: I'D LIKE TO SHOW YOU ANOTHER EXHIBIT. MAY I APPROACH, YOUR HONOR?

2276

BY MR. BOSTIC:

2277

MR. BOSTIC: (HANDING.) DR. YOUNG, I'VE HANDED YOU WHAT HAS BEEN MARKED AS EXHIBIT 5420?

2278

ADAM ROSENDORFF: SORRY, YOU SAID DR. YOUNG. IT'S DR. ROSENDORFF.

2279

MR. BOSTIC: I'M SORRY. DR. ROSENDORFF, I'M SORRY.

2281

MR. BOSTIC: DO YOU HAVE EXHIBIT 5420?

2283

MR. BOSTIC: AND IS IT AN EMAIL DATED AT THE TOP JUNE 13TH, 2014, FROM CHRISTIAN HOLMES TO DANIEL YOUNG?

2285

MR. BOSTIC: AND IS THE SUBJECT LINE HCG DELAYS IN LAB?

2287

MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 5420.

2288

MR. WADE: NO OBJECTION, YOUR HONOR.

2289

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

2290

(GOVERNMENT'S EXHIBIT 5420 WAS RECEIVED IN EVIDENCE.)

2291

BY MR. BOSTIC:

2292

MR. BOSTIC: OKAY. LET'S START ON PAGE 2 OF THIS EXHIBIT, PLEASE. YOU CAN ZOOM IN ON THE TEXT. DO YOU SEE AT THE BOTTOM THERE AN EMAIL FROM CHRISTIAN HOLMES TO DANIEL YOUNG ON JUNE 12TH, 2014?

2294

MR. BOSTIC: AND THIS IS A FEW DAYS AFTER THE EMAILS THAT WE WERE JUST LOOKING AT; CORRECT?

2296

MR. BOSTIC: THIS EMAIL SAYS, "SEEMS LIKE THERE HAVE BEEN MULTIPLE INSTANCES OF HCG TAKING MORE THAN 48 HOURS TO RUN IN THE LAB." DO YOU SEE THAT?

2298

MR. BOSTIC: "THE LAB MENTIONS THAT QC CONTINUES TO FAIL PREVENTING RESULTS GENERATION." DO YOU SEE THAT?

2300

MR. BOSTIC: WHY WOULD QC FAILURE PREVENT RESULTS GENERATION?

2301

ADAM ROSENDORFF: THE REGULATIONS IN GOOD LABORATORY PRACTICE PREVENT RESULTS FROM BEING RELEASED UNLESS QC PASSES ON THEIR INSTRUMENT FOR THAT DAY AT LEAST.

2302

MR. BOSTIC: AND SO, IN OTHER WORDS, CHRISTIAN HOLMES IS SAYING HERE THAT HCG IS TAKING A LONG TIME AND IT SEEMS LIKE A CONTRIBUTING FACTOR IS CONTINUED FAILING OF QC?

2304

MR. BOSTIC: AND DO YOU RECALL THIS BEING AN ISSUE WITH HCG AT THERANOS?

2305

ADAM ROSENDORFF: I RECALL QC FAILURES BEING AN ISSUE WITH MULTIPLE ASSAYS.

2306

MR. BOSTIC: INCLUDING HCG?

2308

MR. BOSTIC: LET'S GO TO PAGE 1 OF THIS EXHIBIT. AND AT THE BOTTOM OF THE PAGE. IF WE CAN ZOOM IN ON THE BOTTOM HALF. CHRISTIAN HOLMES RESPONDS TO AN ANSWER THAT THESE ARE NEW REPORTS AND THE SAMPLES ARE CURRENTLY BEING RUN. HE SAID "HAD TWO DOCS JUST CALL ABOUT HCG DELAYS -- CS CHECKED ON STATUS AND THE LAB SAID THEY ARE FAILING QC AND DON'T HAVE AN EXPECTED TURN AROUND TIME." DO YOU SEE THAT?

2310

MR. BOSTIC: AND IF WE CAN ZOOM IN ON THE TOP HALF OF PAGE 1, PLEASE. DO YOU SEE ON THE PAGE THERE AT THE BOTTOM OF THAT COLLECTION, "WE ARE WORKING IN PARALLEL TO RUN SAMPLE ON EDISON AS WELL AS IMMULITE"?

2312

MR. BOSTIC: AND DR. YOUNG GOES ON TO SAY, "BUT FOUND OUT THIS MORNING THAT REAGENTS FOR IMMULITE ARE ON ORDER AND BACK ORDERED." DO YOU SEE THAT?

2314

MR. BOSTIC: AND SO HE SAYS, "SO WE ARE PUSHING EVEN HARDER TO GET THEM RUN ON EDISONS." DO YOU SEE THAT?

2316

MR. BOSTIC: AND LET'S CALL UP EXHIBIT 4840 IF WE CAN. I BELIEVE IT'S IN EVIDENCE. AND IF WE CAN ZOOM IN ON THE BOTTOM HALF OF PAGE 1. DR. ROSENDORFF, DO YOU RECALL REVIEWING THIS EMAIL DURING CROSS-EXAMINATION?

2318

MR. BOSTIC: DO YOU RECALL DISCUSSING WITH MR. WADE A SUPPLY PROBLEM INVOLVING THE COMMERCIAL REAGENT THAT WAS USED FOR HCG?

2320

MR. BOSTIC: MY QUESTION FOR YOU IS WAS THE PROBLEM AT THAT TIME LIMITED TO REAGENT SUPPLY OR WERE THERE ALSO ISSUES WITH EDISON TEST ACCURACY FOR HCG?

2321

ADAM ROSENDORFF: REVIEWING THE EMAILS TODAY IT SEEMS THAT HCG WAS BEING RUN BOTH ON THE IMMULITE AND ON THE EDISON. THE EDISON RESULTS COULD NOT BE RELEASED BECAUSE OF QC FAILURE, AND IT APPEARS THAT THERE WAS A SUPPLY CHAIN PROBLEM WITH THE IMMULITE REAGENTS.

2322

MR. BOSTIC: AND ARE THOSE TWO DIFFERENT THINGS OR ARE THEY ONE AND THE SAME PROBLEM?

2323

ADAM ROSENDORFF: TWO DIFFERENT THINGS.

2324

MR. BOSTIC: DO YOU SEE THAT CHRISTIAN HOLMES'S EMAIL TO ELIZABETH HOLMES IN THE MIDDLE OF THE PAGE THERE SAYS, "JUST FYI -- HCG RIGHT NOW CAUSING SOME SERIOUS ISSUES AND PATIENT COMPLAINTS." DO YOU SEE THAT?

2326

MR. BOSTIC: HE SAYS, "BEEN SPENDING ALL MORNING TALKING TO DOCS JUST ABOUT HCG AND WILL CONTINUE TO DO SO." DO YOU SEE THAT?

2328

MR. BOSTIC: AND THE EMAIL ABOVE THAT CHRISTIAN HOLMES FOLLOWS UP AND SAYS, "SEEMS LIKE WE ALSO HAVE A CAPACITY ISSUE RIGHT NOW WITH EDISONS AT FULL CAPACITY AND VENOUS SAMPLES IN A SERIOUS QUEUE NOT BEING RUN." DO YOU SEE THAT?

2330

MR. BOSTIC: AND DOES THAT CONFIRM YOUR UNDERSTANDING THAT THE ACCURACY PROBLEMS WITH HCG WERE SEPARATE FROM THE BACKLOG PROBLEM?

2331

ADAM ROSENDORFF: YES, ABSOLUTELY.

2332

MR. BOSTIC: AND JUST TO BE CLEAR, YOU MENTIONED THAT THIS TOLD YOU THAT THE HCG TEST WAS BEING RUN ON THE EDISON AS WELL AS THE IMMULITE; CORRECT?

2333

ADAM ROSENDORFF: SORRY. THESE EMAILS INDICATE THAT, YES.

2334

MR. BOSTIC: AND WHY WAS THE IMMULITE BEING USED IN THE FIRST PLACE FOR THE HCG TEST?

2335

ADAM ROSENDORFF: WELL, I -- ON MAY 30TH, I HAD ORDERED THE HCG TEST TO BE TRANSFERRED FROM THE EDISON TO THE IMMULITE.

2336

MR. BOSTIC: AND WHY WAS THAT NECESSARY?

2337

ADAM ROSENDORFF: BECAUSE OF CONCERNS ABOUT -- AROUND ACCURACY THAT STEMMED FROM PATIENT COMPLAINTS.

2338

MR. BOSTIC: LET'S MOVE FORWARD A LITTLE BIT IN TIME. LET'S LOOK AT EXHIBIT 13876, WHICH IS ALSO IN EVIDENCE. LET'S GO TO PAGE 2. ZOOM IN THERE. AND, DR. ROSENDORFF, DO YOU RECALL THAT THIS IS AN EMAIL FROM YOU TO CHINMAY PANGARKAR AND SURAJ SAKSENA AND SUNNY BALWANI?

2340

MR. BOSTIC: AND YOU ASKED FOR A STATUS UPDATE ON THE HCG AND THE EDISON; CORRECT?

2342

MR. BOSTIC: AND LET'S GO TO THE BOTTOM OF PAGE 1, PLEASE. LET'S ZOOM IN. DO YOU SEE AN EMAIL FROM CHINMAY PANGARKAR SAYING, "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?

2344

MR. BOSTIC: LET'S ZOOM OUT. LET'S LOOK AT THE TOP HALF OF PAGE 1. AND IN THE SECOND TO THE TOP EMAIL YOU ASK, "SO HCG IS BACK ON VACUTAINERS?"

2346

MR. BOSTIC: AND MR. BALWANI ANSWERS YOU, "NO. IT IS ON NANOTAINER'S PER CHINMAY'S EMAIL BELOW." DO YOU SEE THAT?

2348

MR. BOSTIC: AND IN THIS EMAIL ARE YOU ASKING WHAT WAS BEING USED TO RUN HCG AT THIS POINT?

2350

MR. BOSTIC: AND AS LAB DIRECTOR, WHOSE DECISION SHOULD IT HAVE BEEN WHAT DEVICE WAS BEING USED FOR A GIVEN ASSAY AT THERANOS?

2351

ADAM ROSENDORFF: 100 PERCENT THE LABORATORY DIRECTOR.

2352

MR. BOSTIC: IF IT WORKED THAT WAY AT THERANOS, WOULD YOU HAVE HAD TO ASK WHAT METHOD WAS BEING USED FOR A GIVEN ASSAY?

2353

ADAM ROSENDORFF: NO, THERE WOULD HAVE BEEN NO CONFUSION IN MY MIND.

2354

MR. BOSTIC: WE JUST SAW AN EMAIL IN THIS CHAIN INDICATING THAT HCG HAD BEEN EXPERIENCING SOME GOOD QC PERFORMANCE. DO YOU REMEMBER THAT?

2355

ADAM ROSENDORFF: FROM CHINMAY?

2358

MR. BOSTIC: I'D LIKE TO SHOW YOU WHAT WE HAVE MARKED AS EXHIBIT 5421. YOUR HONOR, I THINK I HAVE MORE THAN TWO MINUTES, BUT IF I COULD HAVE THE COURT'S INDULGENCE, I'LL WRAP UP SOON.

2359

JUDGE DAVILA: YES, PLEASE. PLEASE.

2360

MR. BOSTIC: MAY I APPROACH, YOUR HONOR?

2362

BY MR. BOSTIC:

2363

MR. BOSTIC: (HANDING.) DR. ROSENDORFF, DO YOU HAVE IN FRONT OF YOU EXHIBIT 5421, AN EMAIL DATED JUNE 25TH, 2014?

2365

MR. BOSTIC: AND THIS IS JUST A FEW DAYS AFTER THE EMAILS THAT WE WERE JUST LOOKING AT; CORRECT?

2367

MR. BOSTIC: AND DO YOU SEE THE SUBJECT IS INSTRUMENT BREAKUP?

2369

MR. BOSTIC: AND THIS IS AN EMAIL FROM LANGLY GEE TO SUNNY BALWANI AND YOURSELF?

2371

MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 5421.

2372

MR. WADE: NO OBJECTION.

2373

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

2374

(GOVERNMENT'S EXHIBIT 5421 WAS RECEIVED IN EVIDENCE.)

2375

MR. BOSTIC: IF WE CAN ZOOM IN ON THE TEXT.

2376

MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE THAT THIS IS AN EMAIL ABOUT QC PERFORMANCE ON THE EDISONS --

2378

MR. BOSTIC: -- ON THIS DATE IN 2014?

2380

MR. BOSTIC: THE EMAIL FROM LANGLY GEE NOTES, "33 EDISONS QC 6/24 EVENING, 20 EDISONS PASSED." DOES THIS MEAN THAT ONLY 20 OUT OF 33 EDISONS PASSED QUALITY CONTROL ON THAT OCCASION?

2382

MR. BOSTIC: LESS THAN TWO-THIRDS?

2383

ADAM ROSENDORFF: CORRECT, SLIGHTLY LESS THAN TWO-THIRDS, CORRECT.

2384

MR. BOSTIC: AND THE EMAIL THEN GOES ON TO NOTE, "9 EDISONS FOR TES, TSH, HCG, FT4, AND VITAMIN D FAILED LEVEL 1 AND/OR LEVEL 2 QC." DO YOU SEE THAT?

2386

MR. BOSTIC: AND HAVING MULTIPLE EDISONS FAIL QC FOR HCG, WOULD THAT GIVE YOU CONFIDENCE IN THE ACCURACY OF THE EDISON HCG TEST?

2388

MR. BOSTIC: BY THE WAY, THIS EMAIL, THE FIRST LINE OF LANGLY GEE'S EMAIL SAYS AT THE END THERE, "ALL QC'S PASSED UPSTAIRS." DO YOU SEE THAT?

2390

MR. BOSTIC: AND WHAT WAS THE UPSTAIRS PORTION OF THE LAB AT THERANOS?

2391

ADAM ROSENDORFF: THAT'S WHERE THE IMMULITE WAS STATIONED.

2392

MR. BOSTIC: AND WHAT OTHER EQUIPMENT WAS STORED OR USED IN THE UPSTAIRS PORTION OF THE LAB?

2393

ADAM ROSENDORFF: ADVIA 1800'S FOR GENERAL CHEMISTRIES, THE DIASORIN FOR VITAMIN D, AN INSTRUMENT FOR ORDER ANTIBODIES, AN INSTRUMENT FOR PT AND INR. ALL OF THEM WERE PREDICATE FDA APPROVED INSTRUMENTS.

2394

MR. BOSTIC: AND ALL DEVICES BOUGHT BY THIRD PARTIES NOT MANUFACTURED BY THERANOS; CORRECT?

2396

MR. BOSTIC: NOT MODIFIED BY THERANOS?

2398

MR. BOSTIC: WERE THEY FDA APPROVED?

2400

MR. BOSTIC: AND THIS INDICATES THAT FOR THOSE MACHINES ALL QC'S WERE PASSED; CORRECT?

2402

MR. BOSTIC: LET ME SHOW YOU ONE MORE EXHIBIT, WHICH WE'VE MARKED AS 5422. MAY I APPROACH, YOUR HONOR?

2404

BY MR. BOSTIC:

2405

MR. BOSTIC: (HANDING.) DR. ROSENDORFF, IN FRONT OF YOU IS AN EMAIL MARKED EXHIBIT 5422 DATED JUNE 28TH, 2014?

2407

MR. BOSTIC: AND SO JUST A FEW DAYS AFTER THE LAST EMAIL THAT WE LOOKED AT; CORRECT?

2409

MR. BOSTIC: AND NOT QUITE A MONTH AFTER YOUR EMAIL WHERE YOU ATTEMPTED TO HALT EDISON HCG TESTING; CORRECT?

2411

MR. BOSTIC: AND IS THIS ANOTHER EMAIL DISCUSSING QC PERFORMANCE ON THE EDISON?

2413

MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 5422.

2414

MR. WADE: NO OBJECTION.

2415

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

2416

(GOVERNMENT'S EXHIBIT 5422 WAS RECEIVED IN EVIDENCE.)

2417

ADAM ROSENDORFF: I'M SORRY, I HAVE TO GO TO THE BATHROOM AGAIN. I'M SORRY.

2420

JUDGE DAVILA: IF YOU NEED TO TAKE A BREAK, WE'LL TAKE A BREAK. LADIES AND GENTLEMEN, LET'S TAKE ABOUT A FIVE MINUTE BREAK, AND THEN WE'LL COME BACK.

2421

(JURY OUT AT 3:03 P.M.)

2422

JUDGE DAVILA: PLEASE BE SEATED. THANK YOU. THE JURY HAS LEFT. THE WITNESS HAS STEPPED DOWN. ALL COUNSEL AND MS. HOLMES IS PRESENT. YOU'RE JUST GOING TO FINISH WITH THIS DOCUMENT AND THEN WE'LL WRAP IT UP I TAKE IT?

2423

MR. BOSTIC: I HAVE ABOUT 30 SECONDS LEFT, YOUR HONOR.

2424

JUDGE DAVILA: ALL RIGHT. GREAT. WE'LL TAKE A FIVE MINUTE RECESS. THANK YOU.

2425

(RECESS FROM 3:04 P.M. UNTIL 3:09 P.M.)

2426

(JURY IN AT 3:09 P.M.)

2427

JUDGE DAVILA: PLEASE BE SEATED. THANK YOU. WE'RE BACK ON THE READY. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. MR. BOSTIC -- OH, WE'RE MISSING ONE. MR. BOSTIC, YOU HAD A NICE PIC THERE AND I COULDN'T SEE, WHICH IS TO SAY BASKETBALL SEASON IS UPON US, RIGHT?

2428

MR. BOSTIC: I'LL RELY ON THE OTHER MEMBERS OF MY TEAM FOR SPORTS REFERENCE EXPLANATIONS.

2429

(LAUGHTER.)

2430

JUDGE DAVILA: ALL RIGHT. THANK YOU. PLEASE BE SEATED. OUR JURY IS PRESENT. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. MR. BOSTIC.

2431

BY MR. BOSTIC:

2432

MR. BOSTIC: DR. ROSENDORFF, JUST TWO FINAL QUESTIONS ABOUT THE DOCUMENT IN FRONT OF YOU. DO YOU SEE AN EMAIL ON JUNE 29TH, 2014?

2434

MR. BOSTIC: JUNE 28TH, 2014?

2436

MR. BOSTIC: AND WE JUST LOOKED AT AN EMAIL REPORTING THAT ABOUT TWO-THIRDS, NOT QUITE TWO-THIRDS OF EDISONS HAD PASSED QC A FEW DAYS EARLIER; IS THAT CORRECT?

2437

ADAM ROSENDORFF: YES, THAT WAS THE PREVIOUS EMAIL ON JUNE 25TH.

2438

MR. BOSTIC: THIS EMAIL ON JUNE 28TH INDICATES THAT ONLY 17 OUT OF 35 EDISONS PASSED QC FOR THE PRECEDING NIGHT. DO YOU SEE THAT?

2440

MR. BOSTIC: AND IS THAT LESS THAN HALF OF THE EDISONS?

2442

MR. BOSTIC: AND THE FOLLOWING SENTENCE NOTES THAT HCG WAS NOT AVAILABLE FOR TESTING ON THAT DAY. DO YOU SEE THAT?

2444

MR. BOSTIC: MY QUESTION FOR YOU IS AT THERANOS WERE YOUR CONCERNS ABOUT HCG TESTING ACCURACY EVER ADDRESSED TO YOUR SATISFACTION?

2446

MR. BOSTIC: WE SAW A MAY 30TH EMAIL FROM YOU IN ALL CAPS DIRECTING THAT TESTING STOP ON THE EDISON?

2448

MR. BOSTIC: WHY DON'T WE SEE MORE ALL CAPS EMAILS FROM YOU ABOUT THIS ISSUE FOLLOWING THAT DATE?

2449

ADAM ROSENDORFF: AS SHOWN IN THE PREVIOUS EMAIL, THERE WAS SOME UNCERTAINTY IN MY MIND WHAT METHOD WAS BEING RUN FOR HCG. I TRUSTED MY COLLEAGUES THAT THEY WOULD FOLLOW MY INSTRUCTIONS.

2450

MR. BOSTIC: FOLLOWING THIS INCIDENT, DID YOU CONTINUE TO TRUST THAT THE COMPANY WOULD FOLLOW YOUR DIRECTION WHEN IT CAME TO THESE KINDS OF DECISIONS? LET ME ASK IT A DIFFERENT WAY. DID THIS INCIDENT HAVE ANY EFFECT ON YOUR TRUST IN THE COMPANY TO FOLLOW THROUGH ON YOUR DIRECTIONS?

Procedural 2Proc. 2Evening Jury Admonition and Scheduling
2452

MR. BOSTIC: NO FURTHER QUESTIONS FOR TODAY. THIS MIGHT BE A GOOD TIME FOR A BREAK, YOUR HONOR.

2453

JUDGE DAVILA: LET'S -- WE'LL TAKE OUR EVENING RECESS NOW, LADIES AND GENTLEMEN. THANK YOU. AND BEFORE WE DO THAT, I DO NEED TO ADVISE YOU ONCE AGAIN, REMIND YOU OF THE ADMONITION, PLEASE DO NOT DO ANY RESEARCH ON THIS CASE OR ANYONE ATTACHED TO IT. DO NOT PAY ATTENTION AND PLEASE IGNORE ANY INFORMATION THAT YOU MIGHT COME ACROSS IN ANY MEDIA, YOUR SOCIAL MEDIA, ANY CONVERSATIONS YOU MIGHT HAVE WITH OTHER INDIVIDUALS. IF YOU SHOULD INADVERTENTLY COME ACROSS ANY OF THAT MATERIAL, I WOULD ASK YOU TO PLEASE TURN AWAY, TURN OFF THE DEVICE, WHATEVER IT IS, AND YOU CAN TELL ME ABOUT IT TOMORROW MORNING WHEN I ASK THE QUESTION. BUT I APPRECIATE YOUR CONTINUED FIDELITY TO THIS ADMONITION. WE'RE ALL GRATEFUL FOR IT. SO WE'LL TAKE OUR RECESS. WE'LL SEE YOU TOMORROW MORNING AT 9:00 O'CLOCK, 9:00 O'CLOCK. MY SENSE IS THAT WE'LL BE ABLE TO FINISH WITH DR. ROSENDORFF IN THE MORNING, I THINK, AND THEN THE GOVERNMENT WILL HAVE AN ADDITIONAL WITNESS, AND WE CAN PROCEED. ALL RIGHT. THANK YOU VERY MUCH. WE'LL SEE YOU TOMORROW. THANK YOU.

2454

(JURY OUT AT 3:13 P.M.)

2455

JUDGE DAVILA: THANK YOU, DOCTOR. YOU CAN STAND DOWN. WE'LL SEE YOU IN THE MORNING.

2456

ADAM ROSENDORFF: THANK YOU, YOUR HONOR.

2457

JUDGE DAVILA: YOU'RE WELCOME. PLEASE BE SEATED. THANK YOU. ALL RIGHT. THE RECORD SHOULD REFLECT THAT THE JURY HAS LEFT FOR THE DAY. DR. ROSENDORFF HAS LEFT THE COURTROOM. ALL COUNSEL AND MS. HOLMES ARE PRESENT. ANYTHING BEFORE WE END FOR THE DAY? MR. LEACH, YES?

2458

MR. LEACH: VERY BRIEFLY, YOUR HONOR. JUST ONE HOUSEKEEPING MATTER. TOMORROW THE GOVERNMENT ANTICIPATES ABOUT ANOTHER HOUR OF REDIRECT OF DR. ROSENDORFF. WE'RE BUDGETING IN SOME TIME FOR RECROSS. WE HAVE ANOTHER LOCAL WITNESS WHO I ANTICIPATE THE DIRECT WILL BE SOMEWHERE IN THE NEIGHBORHOOD WILL BE AN HOUR AND A HALF TO TWO HOURS. I'M ADVISED BY MR. DOWNEY THE CROSS WOULD BE AN EQUIVALENT LENGTH. BASED ON THAT WE DON'T ANTICIPATE A NEED FOR A THIRD WITNESS TOMORROW, BUT IF THE COURT HAS A PREFERENCE? WE DIDN'T FLY WITNESSES OUT THIS WEEK BECAUSE OF THE SHORT WEEK. IF THE COURT HAS A PREFERENCE, WE CAN FIND SOMEONE ELSE TO FILL WHATEVER VERY SMALL AMOUNT OF TIME WE COULD HAVE. BUT I JUST WANT TO MAKE SURE THAT WE'RE MANAGING THE COURT'S TIME.

2459

JUDGE DAVILA: THANK YOU FOR ADVISING ME OF THAT. MR. DOWNEY, ANY COMMENT? OBSERVATION?

2460

MR. DOWNEY: I THINK PROJECTING LENGTHS SIMILAR TO MR. LEACH AND THEN CONTROLLING FOR THEM A LITTLE BIT. I DON'T THINK THERE'S ANY LIKELIHOOD THAT ANOTHER WITNESS WOULD BE NEEDED BY THE GOVERNMENT. SO I ADVISED MR. LEACH OF THAT, AND I THINK -- I DON'T THINK WE'LL BE PROVEN WRONG IN THAT REGARD.

2461

JUDGE DAVILA: ALL RIGHT. THANK YOU FOR LETTING ME KNOW. MY SENSE IS THAT WE'LL JUST HAVE THIS ONE WITNESS AFTER DR. ROSENDORFF, AND WE'LL SEE HOW FAR WE GET WITH THAT WITNESS, AND THAT WILL BE OUR WEEK I PRESUME.

2462

MR. LEACH: VERY WELL.

2463

MR. DOWNEY: YOUR HONOR, I THINK THERE WILL BE ONE SMALL 403 TYPE WITNESS WITH RESPECT TO THE NEW WITNESS TOMORROW. I DON'T THINK IT INVOLVES ANY DOCUMENTS. I THINK IT WOULD PROBABLY JUST BE A DISCUSSION WITH THE COURT.

2465

MR. DOWNEY: BUT JUST TO APPRISE YOU WE MIGHT NEED THE 8:30 SEGMENT TOMORROW.

2466

JUDGE DAVILA: ALL RIGHT. WE'LL PLAN ON THAT THEN. YOU CAN LET ME KNOW TOMORROW MORNING WHETHER YOU NEED TO CHAT OR NOT OR WHATEVER. OKAY. THAT SOUNDS GOOD.

2467

MR. LEACH: THANK YOU, YOUR HONOR.

2468

MR. DOWNEY: THANK YOU, YOUR HONOR.

2469

JUDGE DAVILA: HAVE A GOOD EVENING EVERYONE.

2470

COURT CLERK: COURT IS ADJOURNED.

2471

(COURT ADJOURNED AT 3:16 P.M.)

← Evidentiary Hearing on Rosendorff's Post-Theranos Employment2 of 2Day 16 →Juror Replaced, Rosendorff Concludes, and Safeway's Former CEO Testifies