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Federal Criminal TrialtranscripttranscriptLynette Sawyer — Direct/Cross - Day 28 - Federal Criminal TrialLynette Sawyer testified about her limited laboratory oversight, faced initial cross-examination, and was followed by an unresolved evidentiary colloquy concerning a CMS report and voided Edison-device tests.
Robert S. LeachLance A. WadeEdward J. DavilaLynette SawyerMr. LeachLynette SawyerJudge DavilaMr. WadeCourt Clerkdirectcrosscolloquy
2 pages·2 witnesses·2,434 lines
Lynette Sawyer testified about her limited laboratory oversight, faced initial cross-examination, and was followed by an unresolved evidentiary colloquy concerning a CMS report and voided Edison-device tests.
Proceedings
DirectLynette Sawyer — DirectLine 17
CrossLynette Sawyer — CrossLine 12
colloquyCMS Report and Voided-Test Evidence ColloquyLine 7

DIRECT EXAMINATION BY MR. LEACH:

MR. LEACH: DR. SAWYER, IF YOU ARE FULLY VACCINATED, I UNDERSTAND YOU HAVE THE PERMISSION OF THE COURT TO REMOVE YOUR MASK DURING TESTIMONY IF YOU'RE COMFORTABLE.

LYNETTE SAWYER: THANK YOU.

MR. LEACH: AND I'LL REMOVE MINE. GOOD AFTERNOON. IN THE FOURTH QUARTER OF 2014, WERE YOU ASKED TO SERVE AS A CO-DIRECTOR OF THERANOS'S CALIFORNIA CLINICAL LABORATORY?

MR. LEACH: AND DID YOU ULTIMATELY AGREE?

MR. LEACH: AND WERE YOU A CO-DIRECTOR OF THERANOS'S CALIFORNIA CLINICAL LABORATORY FROM LATE 2014 THROUGH APPROXIMATELY THE END OF JUNE 2015?

MR. LEACH: WHY DID YOU STOP BEING THE CO-DIRECTOR OF THERANOS'S CALIFORNIA CLINICAL LABORATORY IN JUNE OF 2015?

LYNETTE SAWYER: I HAD ORIGINALLY TAKEN THE JOB, AS DESCRIBED TO ME, IT WAS A TWO TO THREE MONTH FILLER UNTIL THEY HAD ANOTHER DIRECTOR WAS THAT GOING TO BE COMING ON, AND AS THAT TIME WORE ON AND ON, I GREW INCREASINGLY UNCOMFORTABLE WITH THE WAY THINGS WERE DONE IN TERMS OF HOW I WAS DEALT WITH AS A DIRECTOR.

MR. LEACH: I HAVE SOME MORE QUESTIONS ABOUT THAT, BUT LET ME FIRST ASK YOU TO PLEASE DESCRIBE YOUR EDUCATIONAL BACKGROUND FOR US.

LYNETTE SAWYER: I HAVE A DOCTORATE IN PUBLIC HEALTH FROM U.C. BERKELEY. I ALSO AM A LICENSED CLINICAL LABORATORY SCIENTIST, LICENSED PUBLIC HEALTH MICROBIOLOGIST, AND I HAVE A BIOANALYST LICENSE, WHICH IS WHAT ALLOWS ME TO DIRECT LABORATORIES UNDER BOTH CLIA AND CALIFORNIA LAW.

MR. LEACH: LET ME BACK UP A LITTLE BIT FURTHER. DO YOU HAVE A COLLEGE DEGREE?

LYNETTE SAWYER: OH, YEAH, SORRY.

MR. LEACH: WONDERFUL. AND WHERE IS THAT FROM?

LYNETTE SAWYER: SAN DIEGO STATE.

MR. LEACH: AND WHEN DID YOU OBTAIN YOUR COLLEGE DEGREE FROM SAN DIEGO STATE?

MR. LEACH: AND I THINK I HEARD YOU HAVE A MASTER'S DEGREE ALSO.

LYNETTE SAWYER: YES, I DO.

MR. LEACH: AND WHERE IS YOUR MASTER'S DEGREE FROM?

LYNETTE SAWYER: U.C. BERKELEY.

MR. LEACH: AND WHEN DID YOU GET THAT?

MR. LEACH: AND DID YOU ALSO OBTAINED A PH.D. IN PUBLIC HEALTH FROM U.C. BERKELEY?

MR. LEACH: AND WHEN WAS THAT?

MR. LEACH: AND LET'S START WITH THE TIME PERIOD OF 1996 GOING FORWARD. AT A HIGH LEVEL, BRIEFLY DESCRIBE YOUR PROFESSIONAL EXPERIENCE.

LYNETTE SAWYER: I WAS DIRECTING SEVERAL SMALL LABORATORIES FOR A LARGE LABORATORY SYSTEM IN SAN JOSE. I WORKED AT THE VIRUS LAB OF THE CALIFORNIA DEPARTMENT OF PUBLIC HEALTH FOR YEARS DOING HIV RESEARCH. I ALSO DIRECTED A CLINICAL LAB FOR WHAT WAS CHIRON WHAT I STARTED, BAYER BY THE TIME I LEFT, A SMALL CLINICAL LAB THAT THAT BIOTECH COMPANY HAD. SORRY. AND I HAVE DIRECTED SIMILAR LABORATORIES, SMALL CLINICAL LABORATORIES FOR SEVERAL BIOTECH COMPANIES SINCE. I'VE ALSO WORKED AT A LARGE BIOTECH COMPANY DIRECTING RESEARCH AND DEVELOPMENT.

MR. LEACH: HOW DID YOU LEARN ABOUT THERANOS?

LYNETTE SAWYER: I WAS ASKED BY JERRY HURST OF LABORATORY CONSULTING SERVICES, I WAS TOLD THAT THEY NEEDED A DIRECTOR. HE ACTUALLY WAS TALKING TO TWO OF US AT THE TIME. THEY NEEDED A TEMPORARY DIRECTOR AND ASKED IF EITHER ONE OF US WAS INTERESTED IN DOING THAT.

MR. LEACH: AND AT SOME POINT DID YOU SPEAK TO SOMEBODY FROM THERANOS?

LYNETTE SAWYER: I DID BEFORE I ACTUALLY STARTED.

MR. LEACH: WHO DID YOU SPEAK WITH?

LYNETTE SAWYER: I SPOKE WITH SUNNY.

MR. LEACH: SUNNY BALWANI?

MR. LEACH: AND WHAT DID MR. BALWANI TELL YOU?

LYNETTE SAWYER: IT WAS A LONG TIME AGO AND I DO NOT REMEMBER DETAILS OF THE CONVERSATION REALLY, BUT I BELIEVE HE CONFIRMED THAT THEY JUST NEEDED SOMEBODY VERY TEMPORARILY.

MR. LEACH: DID HE TELL YOU ANYTHING ABOUT WHETHER IT WAS FULL-TIME OR PART-TIME?

LYNETTE SAWYER: NO. I KNEW IT WAS PART-TIME GOING IN.

MR. LEACH: OKAY. AND DID HE TELL YOU ANYTHING ABOUT COMPENSATION?

LYNETTE SAWYER: NO. HE AND JERRY HAD ARRANGED THAT. I ACTUALLY AM A SUBCONTRACT FOR LABORATORY CONSULTING SERVICES, SO THAT IS ARRANGED THROUGH THEM.

MR. LEACH: DID MR. BALWANI MENTION ANYONE NAMED ADAM ROSENDORFF?

MR. LEACH: DID HE EXPLAIN ANYTHING ABOUT THE CIRCUMSTANCES OF DR. ROSENDORFF'S DEPARTURE FROM THERANOS?

MR. LEACH: DID HE SUGGEST IN ANY WAY THAT DR. ROSENDORFF HAD CONCERNS ABOUT THERANOS'S LABORATORY TESTING OR PERFORMANCE OF ITS BLOOD ANALYZER?

MR. LEACH: AFTER SPEAKING WITH MR. BALWANI, DID YOU AGREE TO SERVE AS A CO-DIRECTOR OF THERANOS'S CLINICAL LABORATORY IN CALIFORNIA?

MR. LEACH: YOUR HONOR, I ASK PERMISSION TO PUBLISH EXHIBIT 10562, WHICH I BELIEVE IS IN EVIDENCE.

JUDGE DAVILA: YES. THERE IT IS.

MR. LEACH: THANK YOU, YOUR HONOR.

MR. LEACH: AND, DR. SAWYER, DO YOU SEE IN THE LETTER HERE THERE'S A DATE OF DECEMBER 17TH, 2014?

MR. LEACH: AND THIS SAYS, "PLEASE FIND ENCLOSED LFS FORM 193 AND A DIRECTOR'S ATTESTATION ADDING LYNETTE SAWYER, DR. PH, AS A CO-DIRECTOR OF THE THERANOS, INC. CLINICAL LABORATORY." DO YOU SEE THAT LANGUAGE?

MR. LEACH: AND IS THAT CONSISTENT WITH THE TIME PERIOD WHEN YOU TOOK ON THIS ASSIGNMENT?

MR. LEACH: OKAY. WERE YOU EVER ASKED TO -- WERE YOU EVER ASKED TO VISIT THERANOS'S LABORATORY?

MR. LEACH: AT ANY POINT WERE YOU INVITED INTO THERANOS'S CALIFORNIA LABORATORY?

MR. LEACH: DID YOU EVER SET FOOT IN THE LABORATORY?

MR. LEACH: DID YOU EVER SEE SOMETHING CALLED AN EDISON DEVICE?

LYNETTE SAWYER: I DID NOT.

MR. LEACH: HOW ABOUT SOMETHING CALLED THE MINILAB?

MR. LEACH: HOW ABOUT SOMETHING CALLED THE THERANOS SAMPLE PROCESSING UNIT?

MR. LEACH: AND DID YOU EVER SEE ANY OTHER THERANOS MANUFACTURED ANALYZER?

MR. LEACH: DID YOU EVER REVIEW ANY DATA THAT WAS GENERATED FROM AN EDISON DEVICE?

MR. LEACH: HOW ABOUT A MINILAB?

LYNETTE SAWYER: NOT TO MY KNOWLEDGE.

MR. LEACH: HOW ABOUT TSPU?

LYNETTE SAWYER: I'M NOT FAMILIAR WITH THAT TERM.

MR. LEACH: OKAY. DID YOU EVER REVIEW DATA GENERATED FROM WHAT YOU UNDERSTOOD TO BE A THERANOS MANUFACTURED ANALYZER?

MR. LEACH: IN YOUR CALL WITH MR. BALWANI, DID HE TELL YOU THAT THERANOS WAS USING AN EDISON 3.5 DEVICE IN THE CLIA LAB?

MR. LEACH: WHAT DID HE TELL YOU ABOUT TECHNOLOGIES THAT THERANOS WAS DEVELOPING?

MR. LEACH: DID HE TELL YOU THAT THEY WERE USING ANY OTHER THERANOS MANUFACTURED ANALYZER IN THE CLIA LAB?

MR. LEACH: I WANT TO FOCUS ON THE TIME PERIOD LATE 2014 WHEN YOU COME ON AS THE CO-DIRECTOR AND THE END OF JUNE 2015 WHEN YOU RESIGN. SUMMARIZE FOR US WHAT YOU WERE CALLED UPON TO DO.

LYNETTE SAWYER: IN LARGE PART I WAS REVIEWING AND APPROVING SOP'S AND ASSAY VALIDATIONS OR VERIFICATIONS.

MR. LEACH: DID YOU REVIEW ANY SOP'S OR VALIDATION DOCUMENTS RELATED TO SOMETHING CALLED EDISON?

MR. LEACH: SOMETHING CALLED THE MINILAB?

MR. LEACH: SOMETHING CALLED THE TSPU?

MR. LEACH: HOW ABOUT ANY OTHER THERANOS MANUFACTURED ANALYZER?

MR. LEACH: BASED ON THE SOP'S THAT YOU WERE GIVEN, IS IT YOUR IMPRESSION THAT THERANOS WAS DOING SOMETHING OTHER THAN RUNNING BLOOD TESTS ON ORDINARY FDA APPROVED MACHINES AND ORDINARY FDA APPROVED TESTS?

LYNETTE SAWYER: NO. ALL OF THE SOP'S I SAW PERTAINED TO ORDINARY FDA APPROVED ASSAYS.

MR. LEACH: HOW DID YOU RECEIVE THE SOP'S?

LYNETTE SAWYER: UM, ELECTRONICALLY. THEY WERE DOCUSIGNED DOCUMENTS.

MR. LEACH: DID YOU HAVE THE CAPABILITY TO EDIT THEM?

LYNETTE SAWYER: I DID NOT.

MR. LEACH: OKAY. IT WAS ESSENTIALLY, HERE'S THE DOCUMENT, SIGN HERE?

LYNETTE SAWYER: YES. WHEN I HAD ISSUES WITH THEM, I ATTEMPTED TO BRING THOSE UP WITH THE PERSON WHO WAS SENDING THE DOCUMENTS TO ME.

MR. LEACH: DID YOU EXERCISE ANY DECISION MAKING IN TERMS OF WHAT WAS SENT TO YOU?

MR. LEACH: IN THIS TIME PERIOD, LATE 2014 UNTIL JUNE OF 2015, WHO AT THERANOS DID YOU HAVE CONTACT WITH?

LYNETTE SAWYER: REALLY I ONLY HAD CONTACT WITH THE WOMAN WHO WAS SENDING THE SOP'S TO ME.

MR. LEACH: AND DO YOU REMEMBER HER NAME?

LYNETTE SAWYER: NOT RIGHT NOW.

MR. LEACH: IF I TOLD YOU IT WAS MICHELLE LEE, WOULD THAT HELP YOU?

LYNETTE SAWYER: YES, IT WOULD.

MR. LEACH: THAT'S YOUR MEMORY?

MR. LEACH: I DON'T WANT TO TESTIFY HERE FOR YOU, BUT DOES IT REFRESH YOUR RECOLLECTION?

LYNETTE SAWYER: NO. THAT IS WHAT I RECALL.

MR. LEACH: DID YOU HAVE -- OTHER THAN THE ONE -- THE INITIAL PHONE CALL WITH MR. BALWANI, DID YOU HAVE ANY OTHER CONTACT WITH HIM?

LYNETTE SAWYER: NOT DURING THAT TIME PERIOD. I BELIEVE I HAD ANOTHER PHONE CALL WITH HIM WHEN I QUIT.

MR. LEACH: SO THE EXTENT OF YOUR CONTACT WITH SUNNY BALWANI WAS THE INITIAL CALL WHERE YOU WERE ASKED TO TAKE ON THIS SHORT-TERM ASSIGNMENT AND YOUR RESIGNATION?

LYNETTE SAWYER: AS I RECALL, YES.

MR. LEACH: AND OTHER THAN MR. BALWANI AND MS. LEE, DID YOU HAVE CONTACT WITH ANYBODY ELSE AT THERANOS?

LYNETTE SAWYER: THERE WERE A COUPLE OF EMAIL CONTACTS WITH BRAD ARINGTON REGARDING HIS INABILITY TO FIND PAPERWORK THAT I HAD ORIGINALLY SENT, AND A LATER CONTACT ASKING FOR COPIES OF MY CV.

MR. LEACH: OTHER THAN THOSE BRIEF CONTACTS WITH MR. ARINGTON, ANY OTHER CONTACTS WITH ANYONE FROM THERANOS?

MR. LEACH: PRIOR TO RESIGNING IN JUNE OF 2015, DID YOU HAVE ANY CONTACT WITH SOMEONE NAMED SUNIL DHAWAN?

LYNETTE SAWYER: NO, I DID NOT.

MR. LEACH: DO YOU KNOW WHO SUNIL DHAWAN IS?

MR. LEACH: HOW DO YOU KNOW THAT?

LYNETTE SAWYER: FROM HEARING ABOUT THIS TRIAL.

MR. LEACH: PRIOR TO RESIGNING IN JUNE OF 2015, DID YOU HAVE ANY CONTACT WITH YOUR CO-LABORATORY DIRECTOR?

MR. LEACH: AND DID YOU HAVE ANY DISCUSSIONS ABOUT HOW TO DIVIDE RESPONSIBILITIES WITH YOUR CO-LAB DIRECTOR?

MR. LEACH: DID YOU HAVE ANY CONTACT WITH ELIZABETH HOLMES?

MR. LEACH: HAVE YOU EVER MET ELIZABETH HOLMES?

MR. LEACH: AS FAR AS YOU KNOW, IS TODAY THE FIRST TIME THAT YOU HAVE EVER BEEN IN THE SAME ROOM WITH ELIZABETH HOLMES?

MR. LEACH: DID YOU HAVE ANY CONTACT WITH THE TECHNICAL SUPERVISOR?

MR. LEACH: WHAT IS THE TECHNICAL SUPERVISOR?

LYNETTE SAWYER: IT'S THE PERSON WHO IS RESPONSIBLE FOR THE OPERATIONS WITHIN THE LABORATORY, BASICALLY THE TECHNICAL EXPERT ON WHAT GOES ON IN THE LAB.

MR. LEACH: AND YOU DIDN'T HAVE ANY CONTACT WITH THE TECHNICAL SUPERVISOR AT THERANOS?

MR. LEACH: AND DID YOU KNOW WHO THE TECHNICAL SUPERVISOR WAS?

MR. LEACH: DID YOU HAVE ANY CONTACT WITH THE GENERAL SUPERVISOR?

MR. LEACH: DID YOU KNOW WHO THE GENERAL SUPERVISOR WAS?

MR. LEACH: DID YOU DELEGATE RESPONSIBILITIES TO ANYBODY?

LYNETTE SAWYER: I BELIEVE THAT THERE WAS ONE RESPONSIBILITY DELEGATION, YES.

MR. LEACH: AND WHAT IS YOUR RECOLLECTION?

LYNETTE SAWYER: MY RECOLLECTION IS THAT IT WAS A RESPONSIBILITY DELEGATION TO THE TECHNICAL SUPERVISOR, BUT RIGHT THIS MINUTE I DON'T REMEMBER FOR WHAT.

MR. LEACH: IN YOUR TIME AS CO-DIRECTOR FROM THE END OF 2014 UNTIL THE END OF JUNE OF 2015, DID YOU SPEAK TO ANY DOCTORS?

MR. LEACH: DID YOU SPEAK TO ANY PATIENTS?

MR. LEACH: WERE YOU ALERTED TO ANY CRITICAL VALUES?

MR. LEACH: DID YOU REVIEW ANY QUALITY CONTROL DATA?

MR. LEACH: DID YOU RECEIVE ANY REPORTS ABOUT THE ACTIVITIES OF THE LAB?

MR. LEACH: AT ANY POINT DID YOU ORDER TESTING BE TAKEN DOWN ON ANY THERANOS DEVICE?

MR. LEACH: DID YOU EVER ORDER THAT THERANOS -- OR THAT TESTING BE TAKEN UP ON A THERANOS DEVICE?

MR. LEACH: YOUR HONOR, I ASK PERMISSION TO DISPLAY WHAT IS IN EVIDENCE AS EXHIBIT 4553.

MR. LEACH: I'M SORRY. CAN YOU TAKE THIS DOWN, MS. HOLLIMAN. I THINK IT'S 4533. THERE WE GO. MS. HOLLIMAN, IF WE COULD PLEASE HIGHLIGHT THE TOP HALF OF THIS DOCUMENT.

MR. LEACH: HAVE YOU SEEN THIS BEFORE, DR. SAWYER?

LYNETTE SAWYER: NOT THAT I RECALL.

MR. LEACH: OKAY. DO YOU SEE THE DATE SEPTEMBER 23RD, 2015?

MR. LEACH: AND DO YOU KNOW WHETHER THERANOS PROVIDED THIS DOCUMENT TO INSPECTORS FROM CMS ON OR ABOUT THAT DATE?

LYNETTE SAWYER: I DO NOT. I WAS NO LONGER THERE.

MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION TO THE LINE THAT SAYS, THIRD LINE THAT SAYS, "ADDITIONALLY, THE FOLLOWING IS THE LIST OF THE LABORATORY DEVELOPED TESTS THAT THERANOS TESTED ON THERANOS DEVICE, ALSO CALLED THERANOS SAMPLE PROCESSING UNITS (TSPU'S), ALONG WITH THE TIME PERIODS WHEN THOSE TESTS WERE RUN." DO YOU SEE THAT LANGUAGE?

MR. LEACH: AND NOW IF WE CAN PLEASE GO TO THE BOTTOM OF THE PAGE, MS. HOLLIMAN, AND HIGHLIGHT JUST THE BOX, PLEASE. DO YOU SEE A LIST OF 12 ASSAYS LISTED HERE --

MR. LEACH: -- DR. SAWYER?

MR. LEACH: AND AT THE TIME YOU WERE THE LAB DIRECTOR, YOU HAD NO IDEA THAT THERANOS WAS USING ITS DEVICE TO TEST FOR THESE 12 ASSAYS?

MR. LEACH: AND THE FIRST LINE SAID VIT D. DO YOU SEE THAT?

MR. LEACH: AND THE DATES ARE 11/6 -- OR AN INITIAL 11/6/2013, AND AN END OF MARCH 10TH, 2015. DO YOU KNOW WHY THERANOS STOPPED TESTING VITAMIN D ON ITS TSPU IN MARCH 2015?

MR. LEACH: DID ANYONE CONSULT WITH YOU ABOUT THAT?

MR. LEACH: THE NEXT ASSAY IS TSH. DO YOU SEE THAT?

MR. LEACH: AND DO YOU SEE THAT THE END DATE IS FEBRUARY 4TH, 2015?

MR. LEACH: AND THAT'S YOUR TIME PERIOD AS THE LAB DIRECTOR?

MR. LEACH: DID ANYONE CONSULT WITH YOU ABOUT THAT?

MR. LEACH: AND DO YOU HAVE ANY IDEA WHY THERANOS STOPPED USING THE TSPU FOR TSH IN THE CLINICAL LAB?

MR. LEACH: AND THERE ARE SOME ADDITIONAL DATES AS WE GO DOWN ON THIS EXHIBIT FROM FEBRUARY 4TH, 2015, DOWN TO MARCH 6TH, 2015, FT4 TO V B12. DO YOU SEE THAT?

MR. LEACH: AND YOU HAVE NO IDEA WHY THERANOS STOPPED TESTING THESE ASSAYS ON THE TSPU ON THESE DATES?

MR. LEACH: NO ONE CONSULTED YOU ABOUT THAT?

MR. LEACH: AT SOME POINT IN TIME, DID YOU ASK FOR A LIST OF PERSONNEL IN THE THERANOS LAB?

MR. LEACH: AND WHO DID YOU MAKE THAT REQUEST OF?

MR. LEACH: AND DID YOU EVER GET ONE?

MR. LEACH: AND WAS THAT A MATTER OF FRUSTRATION TO YOU?

MR. LEACH: LET ME FOCUS TO JUNE OF 2015. YOU RESIGNED AT THE END OF JUNE OF 2015?

MR. LEACH: AND EXPLAIN TO US WHY YOU ELECTED TO RESIGN.

LYNETTE SAWYER: I ELECTED TO RESIGN BECAUSE I WAS VERY UNCOMFORTABLE WITH THE LACK OF CLARITY THAT I WAS GETTING ABOUT THE LAB, ABOUT PERSONNEL, THE INABILITY TO GET THAT -- IT'S ACTUALLY A FORM THAT LISTS EVERYBODY AND THEIR POSITIONS, AND THE FACT THAT I COULDN'T REALLY TALK -- DIDN'T HAVE A PERSON THAT I COULD ACTUALLY TALK TO ABOUT ISSUES THAT I HAD WITH SOME OF THE SOP'S.

MR. LEACH: DID YOU EXPRESS THAT TO MR. BALWANI?

LYNETTE SAWYER: YES, I BELIEVE SO.

MR. LEACH: AND DID HE TRY TO ENCOURAGE YOU TO STAY?

MR. LEACH: AND TELL US ABOUT THAT.

LYNETTE SAWYER: JUST THAT IT WAS A LITTLE UNCOMFORTABLE BECAUSE HE WAS A BIT PUSHY ABOUT IT.

MR. LEACH: AND DID YOU FEEL LIKE YOU WERE BEING GIVEN THE INFORMATION THAT YOU NEEDED TO DO YOUR ASSIGNMENT?

MR. LEACH: MAY I HAVE A MOMENT, YOUR HONOR?

(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)

MR. LEACH: I HAVE NO FURTHER QUESTIONS, YOUR HONOR. THANK YOU. THANK YOU, DR. SAWYER.

JUDGE DAVILA: CROSS-EXAMINATION?

CROSS-EXAMINATION BY MR. WADE:

MR. WADE: GOOD AFTERNOON, DR. SAWYER.

LYNETTE SAWYER: GOOD AFTERNOON.

MR. WADE: MY NAME IS LANCE WADE, AND I REPRESENT MS. HOLMES. I'LL BE ASKING YOU A FEW QUESTIONS HERE.

MR. WADE: YOUR HONOR, MAY I APPROACH?

BY MR. WADE:

MR. WADE: (HANDING.) I HANDED YOU A BOOK OF DOCUMENTS, AND AT SOME POINT DURING THE EXAMINATION I MAY ASK YOU ABOUT SOME DOCUMENTS, AND IF I DO, YOU'LL SEE THERE ARE SOME NUMERICAL TABS AND I'LL CALL YOUR ATTENTION TO THOSE TABS AND ASK YOU SOME QUESTIONS ABOUT THE DOCUMENT. OKAY?

MR. WADE: I'D LIKE TO BACK UP AND START AND ASK YOU A COUPLE OF QUESTIONS ABOUT HOW YOU GOT TO THERANOS AND YOUR EXPERIENCE AS A LAB DIRECTOR. BUT BEFORE I DO THAT -- WELL, LET ME START THERE. YOU WORKED WITH A GENTLEMAN NAMED JERRY HURST; IS THAT CORRECT?

MR. WADE: AND MR. HURST IS -- HAS A LAB CONSULTING COMPANY; IS THAT RIGHT?

MR. WADE: AND ARE YOU FAMILIAR WITH MR. HURST'S BACKGROUND?

MR. WADE: AND YOU'RE AWARE THAT HE WAS A LONG-TIME CALIFORNIA DEPARTMENT OF HEALTH INSPECTOR?

MR. WADE: AND AFTER HE STOPPED HIS SERVICE WITH THE GOVERNMENT, HE OPENED A CONSULTING SHINGLE. DO YOU RECALL THAT?

MR. WADE: AND HE HAD BEEN DOING CONSULTING FOR, I DON'T KNOW, A COUPLE OF DECADES MAYBE?

LYNETTE SAWYER: POTENTIALLY QUITE A WHILE, YES.

MR. WADE: A LONG TIME. AND HOW LONG DID YOU WORK WITH MR. HURST?

LYNETTE SAWYER: I STILL WORK WITH HIM.

MR. WADE: YOU STILL WORK WITH HIM?

MR. WADE: OKAY. AND WHEN DID YOU START WORKING WITH MR. HURST?

LYNETTE SAWYER: IN A LAB DIRECTOR CAPACITY? I PROBABLY STARTED WORKING WITH HIM IN ABOUT 2013.

LYNETTE SAWYER: 2012 OR 2013. I'M NOT SURE.

MR. WADE: 2012 OR 2013 IN A LAB DIRECTOR CAPACITY?

MR. WADE: DID YOU WORK IN SOME OTHER CAPACITY FOR HIM PRIOR TO THAT?

LYNETTE SAWYER: NOT FOR HIM, NO.

MR. WADE: IN CONNECTION WITH HIS CLIENTS, OR DID YOU WORK --

MR. WADE: -- WITH HIM?

LYNETTE SAWYER: NO. WE WORKED TOGETHER AT THE STATE HEALTH DEPARTMENT.

MR. WADE: OH. SO YOU WERE COLLEAGUES THERE AND SO THAT'S HOW YOU GOT TO MEET HIM THERE IN THE FIRST PLACE?

MR. WADE: OKAY. AND ARE YOU AWARE THAT MR. HURST STARTED DOING CONSULTING WORK FOR THERANOS IN 2011?

MR. WADE: OKAY. YOU'RE AWARE THAT THE WAY THAT YOU ENDED UP GETTING THIS POSITION WAS BECAUSE MR. BALWANI CALLED MR. HURST; CORRECT?

MR. WADE: AND HE WAS CALLING MR. HURST BECAUSE THE COMPANY HAD WORKED WITH MR. HURST PREVIOUSLY; CORRECT?

LYNETTE SAWYER: CORRECT. I KNEW THEY WORKED TOGETHER PREVIOUSLY. I DIDN'T KNOW WHEN.

MR. WADE: OKAY. YOU DIDN'T KNOW WHEN THAT RELATIONSHIP STARTED?

MR. WADE: AND MR. HURST CONSULTS WITH A LOT OF DIFFERENT LAB COMPANIES, DOES HE NOT?

LYNETTE SAWYER: YES, HE DOES.

MR. WADE: AND HE'S SOMEWHAT OF AN EXPERT IN THE FIELD; IS THAT FAIR?

MR. WADE: OKAY. AND A LOT OF TIMES COMPANIES WILL HIRE HIM TO HELP SET UP THEIR LABORATORIES IN THE FIRST INSTANCE; IS THAT RIGHT?

LYNETTE SAWYER: I HAVE KNOWN THAT HAPPEN, YES.

MR. WADE: OKAY. AND HAVE YOU EVER WORKED WITH HIM IN CONNECTION WITH A PROJECT LIKE THAT?

MR. WADE: OKAY. AND SO SOMETIMES HE'S, MR. HURST AND THE COMPANY WILL COME IN ANEW AND THEY'LL WORK TO GET THE WHOLE LAB SET UP, RIGHT, AND ALL OF THE PROCEDURES AND EVERYTHING THAT GO WITH IT?

MR. WADE: AND IN CONNECTION WITH THAT, THERE'S A CERTIFICATION PROCESS?

LYNETTE SAWYER: THE LABORATORY LICENSING PROCESS, YES.

MR. WADE: YOU NEED TO GET IT CERTIFIED BY DIFFERENT STATE REGULATORS AND THE LIKE?

MR. WADE: AND AS YOU SIT HERE TODAY, ARE YOU AWARE WHETHER MR. HURST SERVED IN THAT CAPACITY FOR THERANOS WHEN IT FIRST STARTED OFFERING LAB SERVICES?

LYNETTE SAWYER: I DO NOT KNOW.

MR. WADE: OKAY. AND MR. HURST DOES OTHER THINGS AS WELL; CORRECT?

MR. WADE: IN ADDITION TO HELPING SET UP LABS, HE'LL ALSO COME IN AND LOOK AT LAB PROCEDURES AND HE'LL PROVIDE ADVICE TO LABS ON HOW TO IMPROVE THEIR PROCEDURES; RIGHT?

LYNETTE SAWYER: I CAN'T REALLY SPEAK TO EXACTLY WHAT HE DOES.

MR. WADE: OKAY. WELL, YOU WORK WITH HIS COMPANY? IT'S CALLED LABORATORY CONSULTING SERVICES?

MR. WADE: IS THAT RIGHT?

MR. WADE: AND YOU'RE AWARE THAT THEY HAVE A WEBSITE; RIGHT?

MR. WADE: LET ME DRAW YOUR ATTENTION TO EXHIBIT 10585.

MR. WADE: AND LABORATORY CONSULTING SERVICES WAS ACTUALLY THE ENTITY THAT WAS RETAINED BY THERANOS TO GET LAB DIRECTOR SERVICES WHEN YOU CAME IN TO WORK WITH THERANOS; RIGHT?

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE A PRINTOUT OF THE HOME PAGE OF LABORATORY CONSULTING SERVICES?

LYNETTE SAWYER: PROBABLY, YEAH. I HAVEN'T LOOKED AT IT IN A VERY LONG TIME.

MR. WADE: OKAY. I MOVE THE ADMISSION OF 10585.

MR. LEACH: RELEVANCE. HEARSAY.

JUDGE DAVILA: THE ENTIRETY OF THE DOCUMENT? ALL OF THE PAGES?

MR. WADE: THIS IS THE COMPANY THAT WAS RETAINED TO PROVIDE LABORATORY SERVICES.

JUDGE DAVILA: I'M AWARE OF THAT.

MR. WADE: YES, YES.

JUDGE DAVILA: I'M CURIOUS IF YOU WANT ALL OF THIS, AND WHAT IS THE RELEVANCE OF ALL OF THIS?

MR. WADE: WELL, WHY DON'T I COME BACK TO THIS, YOUR HONOR, AND I THINK MAYBE THE RELEVANCE WILL BECOME CLEAR.

JUDGE DAVILA: OKAY. SURE.

MR. WADE: DO YOU RECALL -- LET ME -- YOU TALKED ABOUT WHEN YOU CAME IN -- I THINK YOU TESTIFIED THAT YOU HAD TWO CONVERSATIONS WITH MR. BALWANI, ONE AT THE BEGINNING OF THE ENGAGEMENT; RIGHT?

LYNETTE SAWYER: I DEFINITELY HAD THAT CONVERSATION, YES.

MR. WADE: AND ONE AT THE END OF THE ENGAGEMENT?

MR. WADE: OKAY. AND -- BUT YOU WERE AWARE THAT MR. BALWANI HAD HAD CONVERSATIONS WITH MR. HURST TO OBTAIN YOUR SERVICES PRIOR TO WHEN YOU COMMUNICATED WITH HIM?

MR. WADE: AND YOU WEREN'T A PARTY TO ANY OF THOSE CONVERSATIONS, WERE YOU?

MR. WADE: OKAY. YOU'RE AWARE ULTIMATELY THAT THERE WAS AN AGREEMENT BY WHICH YOU PROVIDED SERVICES TO THE COMPANY; RIGHT?

MR. WADE: OKAY. LET'S TAKE A LOOK AT 10586. THE COURT'S INDULGENCE FOR ONE MOMENT?

BY MR. WADE:

MR. WADE: DO YOU HAVE THAT IN FRONT OF YOU, MA'AM? DOCTOR?

LYNETTE SAWYER: UH-HUH, YEAH.

MR. WADE: AND DO YOU SEE THAT THIS IS A CONSULTING AGREEMENT?

MR. WADE: AND IF YOU GO TO EXHIBIT A1, WHICH IS A FEW PAGES BACK, THERE'S A LITTLE NUMBER IN THE CORNER IN THE BOTTOM RIGHT THAT SAYS 808. IT ENDS IN 808. DO YOU SEE THAT?

MR. WADE: AND THIS SETS FORTH THE SERVICES AND COMPENSATION FOR LYNETTE SAWYER?

LYNETTE SAWYER: YES, IT SAYS THAT.

MR. WADE: OKAY. I MOVE THE ADMISSION OF 10586.

MR. LEACH: NO OBJECTION, YOUR HONOR.

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

(DEFENDANT'S EXHIBIT 10586 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND DO YOU SEE HERE IN THAT FIRST PARAGRAPH THAT THIS IS AN AGREEMENT DATED NOVEMBER 19TH, 2014 BETWEEN LABORATORY CONSULTING SERVICES AND THERANOS?

LYNETTE SAWYER: YES, IT SAYS THAT.

MR. WADE: OKAY. AND IF YOU LOOK, IT SETS FORTH THE SERVICES AND COMPENSATION AND REFERS TO EXHIBIT A. DO YOU SEE THAT?

MR. WADE: OKAY. LET'S TAKE A LOOK AT -- WELL, BEFORE WE JUMP RIGHT TO EXHIBIT A, LET'S JUST GO TO WHERE THIS IS SIGNED ON BATES RANGE ENDING 807, WHICH I THINK IS ABOUT FIVE PAGES BACK. DO YOU SEE THIS IS SIGNED BY MR. BALWANI AND MR. HURST? DO YOU SEE THAT?

MR. WADE: OKAY. AND IF YOU GO TO THE NEXT PAGE, YOU SEE THAT THIS SETS FORTH THE SERVICES THAT YOU WERE GOING TO PROVIDE FOR THE COMPANY; RIGHT?

MR. WADE: OKAY. AND LET'S LOOK AT A COUPLE OF THINGS HERE. THIS, THIS SAYS THAT YOUR PRINCIPAL COMPANY CONTACT IS SUNNY BALWANI, THE PRESIDENT AND CHIEF OPERATING OFFICER; RIGHT?

LYNETTE SAWYER: THAT SAYS THAT, YES.

MR. WADE: AND DID YOU EITHER LEARN FROM MR. HURST OR DURING YOUR CONVERSATION WITH MR. BALWANI THAT HE ACTUALLY, FROM A MANAGEMENT STANDPOINT, WAS IN CHARGE OF THE LAB?

MR. WADE: OKAY. YOU DIDN'T UNDERSTAND THAT AT THE TIME?

LYNETTE SAWYER: NO, NOT SPECIFICALLY.

MR. WADE: OKAY. BUT I TAKE IT BASED ON HIS TITLE, YOU UNDERSTOOD THAT HE WAS A SENIOR LEADER IN THE COMPANY?

MR. WADE: OKAY. AND THIS AGREEMENT THEN SETS FORWARD VARIOUS SERVICES THAT YOU'RE TO PROVIDE. AND IF WE GO TO THE PARAGRAPH, THE FIRST PARAGRAPH THAT SAYS, "LYNETTE," DO YOU SEE THAT? LET'S HIGHLIGHT THAT AND BLOW THAT UP. THIS SAYS THAT YOU'RE GOING TO SERVE AS THE CO-DIRECTOR OF THERANOS'S CLIA LABORATORY; CORRECT?

MR. WADE: AND THERE'S GOING TO BE ANOTHER CO-DIRECTOR AS WELL; RIGHT?

MR. WADE: AND YOU UNDERSTOOD -- I KNOW MR. LEACH ASKED YOU A LOT OF QUESTIONS, DID YOU EVER DO THIS AND DID YOU EVER DO THAT? DO YOU RECALL SOME OF THOSE QUESTIONS?

MR. WADE: YOU UNDERSTOOD THIS WAS A TEMPORARY AND LIMITED ENGAGEMENT; RIGHT?

MR. WADE: AND YOU UNDERSTOOD AT THE TIME YOU WENT INTO THE ENGAGEMENT THAT THIS WAS GOING TO BE MAYBE AS MANY AS FIVE HOURS A WEEK OR SOMETHING; RIGHT?

LYNETTE SAWYER: POTENTIALLY.

MR. WADE: AND THAT YOU WERE NOT GOING TO BE REQUIRED TO BE ON SITE? THAT WAS A SPECIFIC --

MR. WADE: RIGHT. AND YOU NEVER ASKED TO GO ON SITE; RIGHT?

LYNETTE SAWYER: I DID NOT.

MR. WADE: OKAY. BUT -- AND SOMETIMES LABS HAVE KIND OF PINCH HITTER LAB DIRECTORS; RIGHT?

LYNETTE SAWYER: I SUPPOSE YOU COULD CALL CO-DIRECTORS THAT SOMETIMES.

MR. WADE: OKAY. WELL, YOU UNDERSTAND THAT ONE OF THE SERVICES THAT MR. HURST PROVIDES IS THAT IF A LAB DIRECTOR IS NEEDED BY A LAB COMPANY ON A SHORT-TERM BASIS, THAT HE'LL HELP, HE'LL HELP FACILITATE A LAB DIRECTOR WHO CAN PROVIDE SERVICES ON A TEMPORARY BASIS; RIGHT?

LYNETTE SAWYER: YEAH, THAT WAS MY UNDERSTANDING OF THIS, THAT IT WAS TO BE VERY TEMPORARY, TWO TO THREE MONTHS.

MR. WADE: YEAH. AND YOU UNDERSTOOD THAT MR. HURST DID THAT WITH OTHER COMPANIES AS WELL; RIGHT?

LYNETTE SAWYER: I -- IT WOULD NOT SURPRISE ME, BUT I DO NOT KNOW THAT.

MR. WADE: OKAY. HAVE YOU SERVED AS A LAB DIRECTOR THROUGH MR. HURST FOR OTHER COMPANIES AS WELL?

MR. WADE: AND SOMETIMES HAVE YOU SERVED FOR LAB DIRECTORS FOR MULTIPLE COMPANIES AT ONE TIME?

MR. WADE: AND THOSE JOBS ARE PART-TIME TEMPORARY ASSIGNMENTS; RIGHT?

LYNETTE SAWYER: NOT NECESSARILY TEMPORARY, NO. PART-TIME, YES.

MR. WADE: OKAY. MAYBE THEY'RE FOR A SPECIFIED DURATION?

LYNETTE SAWYER: THEY COULD BE. MOST OF THE OTHER ONES I HAVE DONE ARE NOT. THEY'RE INDEFINITE AS LONG AS WE WANT TO RENEW THE CONTRACT, AS LONG AS BOTH PARTIES WANT TO RENEW THE ACCOUNT.

MR. WADE: OKAY. FAIR ENOUGH. AND UNDER AT LEAST CLIA REGULATIONS, YOU CAN SERVE AS A LAB DIRECTOR FOR AS MANY AS FIVE LABS?

MR. WADE: OKAY. AND YOU KNEW, YOU KNEW WHEN YOU WERE DOING THIS THAT THIS WAS GOING TO BE A TEMPORARY LIMITED ASSIGNMENT; RIGHT?

MR. WADE: AND DID YOU KNOW THAT WAS IN PART BECAUSE THERANOS HAD AN INTERNAL CANDIDATE WHO THEY THOUGHT COULD PROVIDE THE SERVICES WHO JUST NEEDED TO COMPLETE SOME CERTIFICATION PAPERWORK?

MR. LEACH: OBJECTION. FOUNDATION.

MR. WADE: IF YOU KNOW.

JUDGE DAVILA: SUSTAINED. SUSTAINED. YOU CAN ASK ANOTHER QUESTION, BUT WHY DON'T YOU DO THAT TUESDAY?

MR. WADE: THAT'S A GREAT IDEA, YOUR HONOR. THE LAST THING I WANT TO DO IS STAND BETWEEN THE END OF THIS WEEK AND THIS JURY, SO --

JUDGE DAVILA: LET'S DO THAT. SO WE'LL RESUME AGAIN TUESDAY, PLEASE RECALL, TUESDAY, TUESDAY NEXT, WHICH IS NOVEMBER 9TH, AND WE'LL DO THAT AT 9:00 A.M., LADIES AND GENTLEMEN, 9:00 A.M. I CAN'T RECALL IF I ASKED YOU IF IT WAS A 3:00 O'CLOCK DAY OR A 4:00 O'CLOCK DAY. CAN WE GO UNTIL 4:00 O'CLOCK ON TUESDAY, THE 9TH, WITHOUT ANY OBJECTION? I DON'T SEE ANY HANDS. LET'S TRY TO DO THAT. THANK YOU VERY MUCH. BEFORE WE BREAK, LADIES AND GENTLEMEN, I REMIND YOU AGAIN OF THE ADMONITION. PLEASE AVOID ANYTHING TO DO WITH THIS CASE OUTSIDE OF THIS COURTROOM. PLEASE DO NOT WATCH, LISTEN TO, READ, OR TALK ABOUT THIS CASE IN ANY WAY, AND PLEASE DO NOT FORM ANY OPINION ABOUT THIS CASE OR ANYTHING TO DO WITH IT. ON TUESDAY NEXT I'LL ASK YOU IF THOSE THINGS HAVE OCCURRED AND YOU'LL LET ME KNOW. OTHER THAN THAT, PLEASE ENJOY YOUR WEEKEND AND WE'LL SEE YOU TUESDAY. THANK YOU. AND, DR. SAWYER, WE'LL SEE YOU TUESDAY NEXT. THANK YOU.

colloquycolloquyCMS Report and Voided-Test Evidence Colloquy

(JURY OUT AT 4:03 P.M.)

JUDGE DAVILA: YOU CAN STAND DOWN. THANKS. PLEASE BE SEATED. THE RECORD SHOULD REFLECT THE JURY HAS LEFT FOR THE WEEKEND. ALL COUNSEL AND MS. HOLMES ARE PRESENT. GIVE ME JUST A SECOND. ALL RIGHT. DR. SAWYER HAS LEFT. ANYTHING FURTHER BEFORE WE BREAK FROM EITHER SIDE?

MR. LEACH: ONE MATTER, YOUR HONOR.

JUDGE DAVILA: YES, PLEASE.

MR. LEACH: YOUR HONOR, AFTER DR. SAWYER'S TESTIMONY, THE GOVERNMENT ANTICIPATES CALLING DR. KINGSHUK DAS, WHO WAS THE LAB DIRECTOR AFTER SUNIL DHAWAN WHO WAS AT THERANOS AT THE TIME THAT THERANOS RECEIVED THE CMS INSPECTION REPORT, THE 2567 THAT HAS BEEN THE SUBJECT OF A NUMBER OF MOTION PRACTICE. HE'S ALSO THE LAB DIRECTOR WHO VOIDED ALL OF THE TESTS ON THERANOS'S EDISON DEVICE, WHICH WAS ALSO THE SUBJECT OF SOME MOTION IN LIMINE PRACTICE. IN ONE OF THE ORDERS THE GOVERNMENT DIRECTED -- IF THE COURT MAY RECALL IN THE ORIGINAL MOTION IN LIMINE ORDER, I THINK IT'S 798, THE COURT ADMITTED THE CMS REPORT. AFTER THAT THE DEFENSE FILED A MOTION FOR CERTAIN REDACTIONS. THE COURT NOTED THE FACT THAT IT APPEARED TO BE A MOTION FOR RECONSIDERATION, BUT DEFERRED RULING ON IT AND ORDERED THE GOVERNMENT TO PROVIDE NOTICE OF WHEN IT INTENDED TO ADMIT THE REPORT. WE DO INTEND TO ADMIT THE REPORT AT SOME POINT NEXT WEEK.

AND OUR POSITION NOW IS THAT THE FULL REPORT IS ADMISSIBLE FOR A NUMBER OF REASONS, AND I'M HAPPY TO EXPLAIN AT THE APPROPRIATE TIME. IN ADDITION, IN THE MIL ORDER, THE COURT, WITH RESPECT TO THE VOIDING OF THE TESTS, DEFERRED RULING UNTIL THE GOVERNMENT PROFFERED A CONNECTION BETWEEN THE VOIDING AND THE CHARGED CONDUCT, AND A FACTUAL BASIS THAT IT WAS DONE INVOLUNTARY. THE GOVERNMENT IS PREPARED TO MAKE THAT PROFFER AT ANY TIME THE COURT DEEMS APPROPRIATE. WE THINK IT CLEARLY CONNECTS TO THE CHARGED CONDUCT FOR A NUMBER OF REASONS. AND DR. DAS HAS SAID ON MULTIPLE OCCASIONS, AND I ANTICIPATE HE WILL SAY AGAIN IN THE NEXT FEW DAYS, THAT HE WAS LEGALLY REQUIRED TO VOID THE TESTS AND HAD COMMUNICATIONS WITH MS. HOLMES ABOUT THE NEED TO DO THAT, AS WELL AS THE TESTING CAPABILITIES OF THE EDISON DEVICE. SO THERE'S A NUMBER OF ISSUES RELATING TO THE MOTION IN LIMINE ORDER THAT I THINK WARRANT SOME DISCUSSION. I WAS HOPEFUL WE MIGHT BE ABLE TO DO THAT ON MONDAY, BUT I NOW UNDERSTAND MEMBERS OF THE DEFENSE TEAM HAVE IMPORTANT COMMITMENTS THAT DAY THAT WE DON'T NECESSARILY WANT TO INTERFERE WITH. BUT WE WOULD LIKE TO FIND SOME TIME TO VET THESE ISSUES IN ADVANCE OF HIS TESTIMONY.

JUDGE DAVILA: THANK YOU. MR. WADE, YOU'RE HANDLING THIS, I TAKE IT?

MR. WADE: I AM, YOUR HONOR.

JUDGE DAVILA: SO I KNOW WE WON'T BE ABLE TO DISCUSS THIS MONDAY, AND THE WITNESS -- WE'LL HAVE DR. SAWYER -- IS IT LIKELY WE'LL FINISH DR. SAWYER TUESDAY?

MR. WADE: WE WILL. I, I -- AND I APOLOGIZE FOR THE CONFLICT. I DON'T KNOW IF THERE IS --

JUDGE DAVILA: OH, NO, NOT AT ALL. GOSH. NO.

MR. WADE: -- IF THERE'S ANY WAY TO SWITCH DR. DAS TO TUESDAY OR TO WEDNESDAY, AND THEN WE'LL HAVE A LITTLE MORE TIME TO DEAL WITH IT.

JUDGE DAVILA: I WANTED TO ASK ABOUT SCHEDULING. I DON'T KNOW IF DR. DAS IS LOCAL OR NOT.

MR. LEACH: HE IS IN MINNESOTA UNFORTUNATELY, YOUR HONOR, AS ARE A NUMBER OF UPCOMING WITNESSES, INCLUDING ALAN EISENMAN WHO WAS HERE EARLIER. I KNOW HE'S COMING BACK IN FROM OUT OF THE COUNTRY. SO DR. DAS WAS REALLY, HE WAS THE NEXT LOGICAL PERSON UP, AND IT'S A SHORT WEEK NEXT WEEK, SO WE HAVE A BIT OF A CHALLENGE IN COORDINATING SOME OF THE OUT-OF-TOWN WITNESSES.

MR. WADE: I DO ANTICIPATE WITH THIS -- AS YOUR HONOR MAY RECALL, THERE WERE SOME MOTIONS RELATING TO DR. DAS JUST BEFORE THE TRIAL BEGAN. I THINK SOME OF THOSE MOTIONS -- I HAVEN'T GONE BACK TO LOOK AT THE BRIEFING AND THE ORDER ON THAT, BUT I THINK THERE ARE SOME ISSUES THAT REMAIN WITH RESPECT TO DR. DAS AND WHETHER IT'S EXPERT TESTIMONY OR FACT TESTIMONY. THE TRIAL IN THAT RESPECT HAS PROCEEDED SOMEWHAT UNEXPECTEDLY. FROM THE DEFENSE PERSPECTIVE, WE WOULD HAVE THOUGHT, WE WOULD HAVE THOUGHT THAT THE GOVERNMENT WOULD HAVE OFFERED THE CMS REPORT THROUGH A CMS WITNESS, AND I WANT TO THINK ABOUT WHETHER THEIR FAILURE TO DO SO CREATES ANY ADDITIONAL CONCERNS. IT WOULD APPEAR -- I INFER THEY'RE INTENDING TO OFFER IT THROUGH DR. DAS IF THEY'RE RAISING THESE ISSUES NOW. SO I THINK THERE ARE A LOT OF THORNY LEGAL ISSUES. WE CAN OBVIOUSLY -- OUR TEAM CAN DO SOME WORK ON THEM OVER THE WEEKEND. WE CAN TRY TO TAKE THEM UP, YOU KNOW, TUESDAY MORNING. I JUST WORRY ABOUT -- I DON'T WANT TO HAVE A SITUATION WHERE WE'RE BLENDING INTO THE TRIAL TIME.

JUDGE DAVILA: RIGHT. THANK YOU FOR THAT. I JUST DON'T WANT TO INCONVENIENCE THE TRIAL PROCESS, AND PARTICULARLY WITNESSES THAT ARE FLYING IN FROM THE GREAT STATE OF MINNESOTA AND ELSEWHERE. THAT'S REALLY AN INCONVENIENCE.

JUDGE DAVILA: AND THAT'S WHY I'M CURIOUS ABOUT -- DR. SAWYER IS LOCAL?

JUDGE DAVILA: SO I HOPE WE DON'T HAVE TO INTERRUPT HER TESTIMONY IN FAVOR OF ANOTHER TESTIMONY, BUT IT SOUNDS LIKE DR. DAS IS PROBABLY GOING TO BE A LENGTHY EXAMINATION.

MR. LEACH: THE GOVERNMENT'S ESTIMATE OF ITS DIRECT AT THIS POINT, YOUR HONOR, IS ONE TO TWO HOURS. I DON'T KNOW WHAT THE DEFENSE INTENDS.

MR. WADE: IT SOUNDS LIKE IT COULD BE ONE LONG DAY. WE OBVIOUSLY DON'T KNOW THE SCOPE OF THE ISSUES THAT THEY INTEND TO GO INTO. AND PART OF THAT, TOO, WILL RAISE SOME ISSUES, YOUR HONOR. I KNOW A LOT OF ISSUES HAVE COME UP WITH RESPECT TO CONDUCT THAT HAPPENED REALLY AFTER THE RELEVANT TIME PERIOD AND IS RETROSPECTIVE IN NATURE. AND I THINK THERE HAVE BEEN SOME LIMITATIONS THAT HAVE BEEN IMPOSED ON THAT. A LOT OF DR. DAS'S KNOWLEDGE RELATES TO THAT. YOU KNOW, HE DIDN'T START WORK -- HE STARTED WORKING TEMPORARILY WITH THE COMPANY IN LATE 2015 AND THEN IN 2016, AND HE'S NOT REALLY A PERCIPIENT FACT WITNESS WITH RESPECT TO MOST OF THE PERTINENT CONDUCT. HE'S EFFECTIVELY GOING TO OPINE UPON HIS REVIEW OF THE HISTORICAL CONDUCT. SO I DO THINK IT CREATES SOME POTENTIAL RELEVANCE ISSUES AND, YOU KNOW IT MAYBE RIPENS UP SOME OF THOSE EXPERT ISSUES.

JUDGE DAVILA: WELL, AND THEN, MR. LEACH, IT SOUNDS LIKE YOU'VE SAID THAT YOU WILL AT LEAST MAKE AN OFFER OF PROOF AS TO THAT CONNECTION ISSUE WITH MS. HOLMES. YOU ARE INDICATING THAT YOU CAN ESTABLISH THAT THROUGH THIS WITNESS.

MR. LEACH: THERE IS, YOUR HONOR.

MR. LEACH: THE DEFENDANT STATED IN HER OPENING THAT IN 2016 THEY FORMED A SCIENTIFIC ADVISORY BOARD. SHE STATED THAT SHE BROUGHT ON EXPERTS. SHE'S ELICITED TESTIMONY ABOUT THE AAC CONFERENCE IN 2016 THROUGH GENERAL MATTIS, THEY OFFERED DOCUMENTS FROM MARCH OF 2016 ABOUT SCIENTIFIC OPINIONS THAT SHE'S RECEIVING, ALL OF WHICH TO SUGGEST THAT, YOU KNOW, A GUILTY -- A PERSON WHO IS CONFIDENT IN HER TECHNOLOGY WOULD NOT DO THESE THINGS AND THAT SHE, THEREFORE, DID NOT HAVE THE INTENT TO DEFRAUD. IF THEY'RE GOING TO HOLD OUT THESE 2016 EVENTS AS INDICATIVE OF HER GOOD FAITH AND INTENT, THE GOVERNMENT SHOULD BE ABLE TO COMPLETE THE PICTURE OF WHAT WAS REALLY MOTIVATING HER AT THOSE PERIODS OF TIME. IN ADDITION, I ANTICIPATE DR. DAS WILL SAY THAT WHEN HE TOLD MS. HOLMES WE NEED TO VOID THE TESTS, HE GOT PUSH BACK. SHE DID NOT WANT TO DO THAT. SHE CAME UP WITH ALTERNATIVE REASONS FOR IT. AND THAT PUSH BACK IS CONSCIOUSNESS OF GUILT. IT GOES TO HER STATE OF MIND ABOUT THERANOS'S TECHNOLOGY.

AND FOR THAT REASON IT VERY CLEARLY CONNECTS. I WOULD ALSO ADD THAT ONE OF THE POINTS THAT THE GOVERNMENT IS TRYING TO PROVE IS THAT, YOU KNOW, AT THE END OF THE DAY, THE TESTS WERE INACCURATE AND THE VOIDING OF THE TESTS SPEAKS TO WHETHER THE TESTS WERE ACCURATE OR NOT. SO WE THINK, ALTHOUGH THE VOIDING IS IN 2016, IT CLEARLY CONNECTS TO HER INTENT AT THE TIME. THE DEFENSE HAS INJECTED THINGS THAT SHE'S DOING IN 2016 TO TRY TO SUGGEST A GUILTY PERSON WOULD NOT DO THOSE THINGS, AND I THINK THE WHOLE TRUTH HERE, YOUR HONOR, IS THEY CAME UP WITH AN EXPLANATION FOR WHY THEY WERE VOIDING THE TESTS, THEY MINIMIZED THOSE ISSUES TO THEIR INVESTORS, AND WHEN SHE'S GOING TO ACC AND THESE OTHER THINGS, IT'S A PR SPIN, NOT GENUINE INDICATION OF CONFIDENCE IN HER TECHNOLOGY. IT GOES RIGHT TO HER STATE OF MIND, AND DR. DAS LAYS THAT FOUNDATION.

MR. WADE: YOUR HONOR, WE'VE HAD -- WE'VE DISCUSSED THESE ISSUES AT LENGTH BEFORE. THE ARGUMENT THAT WAS JUST MADE -- YOU KNOW, WE WANTED TO OFFER EVIDENCE RELATED TO THESE VERY ISSUES RECENTLY THROUGH MANY WITNESSES ACTUALLY AND THE GOVERNMENT HAS OBJECTED TO OUR OFFERING THE EVIDENCE. AND SO IN THIS CASE THEY WANT TO OFFER THE EVIDENCE THAT GOES, GOES DEEP INTO THIS. THERE WERE SEVERE LIMITATIONS IN TERMS OF -- AND WE WERE VERY CAUTIOUS TO TRY TO -- WE DIDN'T PLAY THE AACC PRESENTATION. DR. DAS IS ANOTHER WITNESS WHO OBSERVED THE AACC PRESENTATION, I BELIEVE, AND SO HE CAN TESTIFY TO IT. THERE ARE INCONSISTENT LINES BEING DRAWN ON THE GOVERNMENT AS TO WHAT IS FAIR GAME AND WHAT IS NOT, AND MY CONCERN IS THAT THESE WITNESSES' PATHS, THEIR APPROACH DIFFERS, AND THEN WE MISS THE OPPORTUNITY TO CROSS-EXAMINE THE WITNESSES ON THESE POINTS. A LOT OF WHAT HE'S TALKING ABOUT IS DEALING WITH HISTORICAL PROBLEMS, AND THAT'S WHY WE THINK, YOU KNOW, THERE MAY BE 701, 702 ISSUES. BUT I THINK FOR PURPOSES OF TODAY, YOUR HONOR, I THINK WHAT I'M RAISING FOR THE COURT IS THAT THIS IS A COMPLICATED -- THIS IS ABOUT AS COMPLICATED A SET OF KIND OF LEGAL ISSUES IN TERMS OF ADMISSIBILITY AS I THINK WE'VE HAD WITH A WITNESS, AND I WORRY A LITTLE BIT JUST FROM A SCHEDULING STANDPOINT HERE. SO I'M NOT SURE WHAT THE PATH FORWARD FROM THAT STANDPOINT IS.

JUDGE DAVILA: THANK YOU. I THINK WE SHOULD MEET PROBABLY TUESDAY AT 8:00 O'CLOCK TO DISCUSS AND AT LEAST TRY TO GET A PATH TO THIS, AND IT MAY BE THAT THAT MAY DEFER DR. SAWYER. I KNOW IT'S AN INCONVENIENCE, BUT I'D LIKE TO GET HER FINISHED. WHAT DID YOU TELL ME?

MR. WADE: I DON'T THINK DR. SAWYER WILL BE A LONG WITNESS. I WOULD EXPECT THE REMAINING CROSS WOULD BE AN HOUR OR LESS.

JUDGE DAVILA: OKAY. AND THEN DR. DAS WILL BE HERE TUESDAY?

MR. LEACH: HE'S CURRENTLY SCHEDULED TO BE HERE ON TUESDAY, YOUR HONOR.

JUDGE DAVILA: I SEE. WELL, IF WE'RE GOING TO HAVE DISCUSSION OF THIS ON TUESDAY MORNING -- AND THEN THE OTHER WITNESS IS COMING IN SOMETIME LATER IN THE WEEK? IS THAT THE ANTICIPATION.

MR. LEACH: I THINK WE ANTICIPATE MR. EISENMAN ON WEDNESDAY, BUT I HAVE NOT FULLY CONNECTED WITH MY TEAM.

JUDGE DAVILA: JUST IN LIGHT OF WHAT I'M HEARING, THAT SOUNDS OPTIMISTIC AT BEST.

MR. LEACH: I'M SORRY?

JUDGE DAVILA: IT SOUNDS OPTIMISTIC AT BEST. IF DR. DAS TESTIFIES, IF WE GO THROUGH THIS CONVERSATION THAT WE'LL HAVE TO HAVE ON TUESDAY SOMETIME, AND IT'S A SHORT WEEK, ISN'T IT? YEAH.

JUDGE DAVILA: WE JUST HAVE TWO DAYS. RIGHT. LET ME JUST ASK, IS IT LIKELY WE'LL GET TO THE SECOND WITNESS? I'M LOOKING AT YOU, MR. WADE.

MR. WADE: THE SECOND WITNESS BEING?

JUDGE DAVILA: OTHER THAN DR. DAS?

MR. WADE: IF DR. DAS IS THE WITNESS?

MR. WADE: A LOT IS GOING TO DEPEND ON THE SCOPE AND WHETHER THERE IS A LINK. BUT I WOULD EXPECT THAT WE COULD GET DR. DAS IN IN THE EQUIVALENT OF A TRIAL DAY.

JUDGE DAVILA: SO I'M LOOKING --

MR. WADE: IF HE TESTIFIES ON DIRECT FOR AN HOUR TO TWO HOURS.

JUDGE DAVILA: SO I'M JUST TRYING TO BE REALISTIC. WE'RE GOING TO HAVE A CONVERSATION ABOUT THE LEGAL LIMITS, IF THERE ARE ANY, AS TO DR. DAS. THAT'S GOING TO TAKE US A COUPLE OF HOURS, I THINK. I'M JUST -- JUST BASED ON THE WAY THINGS ARE GOING. AND THEN IF HE TESTIFIES, ASSUMING THAT DR. SAWYER DOESN'T FINISH ON TUESDAY.

MR. WADE: DR. SAWYER WILL CERTAINLY FINISH ON TUESDAY. SHE'LL FINISH EARLY ON TUESDAY.

JUDGE DAVILA: SO IF WE FACTOR IN ANOTHER HOUR, THAT'S THE MORNING, ISN'T IT?

JUDGE DAVILA: AND THEN DR. DAS STARTS THE AFTERNOON OF TUESDAY -- OR EXCUSE ME. CAN YOU GET DR. DAS DONE ON WEDNESDAY? I'M JUST SAYING, I DON'T THINK WE'RE GOING TO GET THAT OTHER WITNESS IN. I JUST DON'T SEE IT REALISTICALLY, BUT --

MR. LEACH: WE'LL BE PREPARED IN ANY EVENT, YOUR HONOR, AND, YOU KNOW, THE GOVERNMENT IS TRYING TO MOVE AS EFFICIENTLY AS POSSIBLE.

MR. LEACH: AND MY INTEREST IS NOT TO HAVE DR. DAS ON THERE FOR MORE THAN ONE TO TWO HOURS. COMING INTO THIS CONVERSATION, MY EXPECTATION WAS THAT WE COULD DO IT AT A NORMAL TRIAL DAY. IF WE START ON TUESDAY, I'M CONVINCED THAT WE CAN FINISH ON WEDNESDAY. AND IF WE'RE STARTING ANOTHER WITNESS, THE GOVERNMENT WILL GIVE THOUGHT TO, IS THERE A LOCAL WITNESS THAT WE CAN SUBSTITUTE IN? OR ANOTHER OUT-OF-TOWN WITNESS WITH FEWER SCHEDULING CONFLICTS? BUT I -- FROM MY PERSPECTIVE, HE COULD BE DONE IN A DAY. AND I JUST NEED TO ADD, MANY OF THESE LEGAL ISSUES HAVE BEEN FULLY VETTED THROUGH EXTENSIVE MOTION PRACTICE.

JUDGE DAVILA: SURE. YOU'RE CUTTING ME OFF AND YOU'RE SAYING, JUDGE, DON'T ASK ME -- DON'T ASK US TO PROVIDE YOU WITH UP TO FIVE PAGES OF ADDITIONAL BRIEFING ON THIS.

MR. LEACH: WE'RE HAPPY TO PROVIDE BRIEFING, YOUR HONOR. BUT I'M THINKING BACK TO OUR THREE DAY MOTION IN LIMINE HEARING, AND I WOULD LIKE TO AVOID BLEEDING INTO THE TRIAL DAY AS MUCH AS WE CAN.

JUDGE DAVILA: NO. I AGREE. I'M NOT GOING TO ASK YOU TO DO THAT. BUT I DO THINK, JUST BASED ON SOME OF THE THINGS THAT YOU'VE TALKED ABOUT HERE, WE ARE IN TRIAL NOW, AND I THINK, MR. LEACH, WHAT YOU'VE TOLD ME IS YOU BELIEVE SOME OF THE TESTIMONY AND THE EVIDENCE THAT HAS BEEN RECEIVED HERE ALLOWS A PATH FORWARD TO THE TESTIMONY THAT YOU WOULD LIKE TO INTRODUCE. DID I --

JUDGE DAVILA: AND I THINK WHAT I WOULD LIKE TO ASK YOU TO DO IS TO PUT THAT IN WRITING FOR ME, SO YOU CREATE YOUR PATH IN WRITING THAT SUGGESTS AND SO COUNSEL CAN BE AWARE OF THE PATH FORWARD WITH DR. DAS FOR THE ISSUES THAT YOU'D LIKE TO INTRODUCE, AND THAT WOULD BE HELPFUL TO ME. WE SHOULD PROBABLY GET THAT SOMETIME -- I'M NOT GOING TO ASK YOU FOR TOMORROW. TOMORROW IS FRIDAY, AND WE'RE GOING TO TALK ABOUT THIS TUESDAY. SO IF I COULD HAVE IT ON MONDAY, THAT WOULD BE HELPFUL, NO LATER THAN MIDDAY MONDAY WOULD BE HELPFUL.

MR. LEACH: WILL DO, YOUR HONOR.

MR. WADE: AND JUST SO OUR THINKING IS CLEAR ON THAT, AND FOR THE BENEFIT OF THE PARTIES TO TRY AND TEE THIS UP, I THINK WHAT I HEAR FROM MR. LEACH IS A COUPLE OF ISSUES. I HEAR THE ADMISSIBILITY OF THE CMS REPORT AND WHAT PORTIONS OF THE CMS REPORT IS ONE ISSUE. THERE'S THE VOIDING ISSUE, WHICH IS ANOTHER ISSUE WHICH IS PART OF PRIOR MOTIONS PRACTICE. AND THEN THE THIRD ISSUE IS THE 701, 702 ISSUE. I DON'T KNOW IF WE HAVE OTHER ISSUES OR NOT, BUT THOSE ARE THE THREE ISSUES THAT I THINK MR. LEACH IS REFERRING TO.

JUDGE DAVILA: ALL OF US HAVE ISSUES, MR. WADE.

(LAUGHTER.)

MR. WADE: SO WE'LL WORK TO RIPEN THOSE UP FOR DISCUSSION WITH THE COURT.

JUDGE DAVILA: SURE. AND IF YOU WANT TO -- IT WOULD BE HELPFUL TO ME TO GET THAT BEFORE NOON ON MONDAY. WELL, YOU'VE GOT ALL DAY TOMORROW, AND THEN, OF COURSE, THAT'S WHAT THE WEEKENDS ARE FOR, SO -- BUT THAT WOULD BE HELPFUL FOR ME TO DIGEST, AND THEN I'LL LOOK AT IT. AND I THINK YOU ALSO SUPPLIED SOME SUPPLEMENTAL INFORMATION EARLIER AS WELL. SO I'LL LOOK AT THAT, AS WELL AS OUR MOTIONS, OUR MOTIONS IN LIMINE. OKAY?

MR. LEACH: WILL DO, YOUR HONOR.

MR. WADE: THANK YOU, YOUR HONOR.

COURT CLERK: THANK YOU. COURT IS ADJOURNED.

(COURT ADJOURNED AT 4:20 P.M.)