CMS Evidence and Dr. Das Testimony Hearing
212 linesSAN JOSE, CALIFORNIA NOVEMBER 9, 2021 P R O C E E D I N G S
(COURT CONVENED AT 8:23 A.M.)
(JURY OUT AT 8:23 A.M.)
JUDGE DAVILA: ALL RIGHT. LET'S GO ON THE RECORD IN THE HOLMES MATTER. ALL COUNSEL ARE PRESENT. MS. HOLMES IS PRESENT. WE'RE OUTSIDE OF THE PRESENCE OF THE JURY TAKING UP A COUPLE OF MATTERS REGARDING SOME EVIDENCE. LET'S SEE. I THINK WE'RE GOING TO TALK THIS MORNING ABOUT DOCKET 1086, 1133, AND 1134, AMONGST OTHERS, WHICH WILL PROBABLY INCLUDE A DISCUSSION OF 989 AS WELL. THOSE ARE WHAT I'VE IDENTIFIED. HAVE YOU IDENTIFIED, FOLKS, WHO IS GOING TO SPEAK TO THESE? MR. LEACH AND MR. WADE?
MR. LEACH: I'LL BE SPEAKING TO THIS, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU.
MR. WADE: GOOD MORNING, YOUR HONOR. LANCE WADE ON BEHALF OF MS. HOLMES. I'LL DEAL WITH A SUBSTANTIAL PART OF THIS. THERE ARE CERTAIN ISSUED RELATING TO THE CMS REPORT THAT I HAVE MR. LOOBY'S PRESENCE TO HELP THE COURT WITH.
JUDGE DAVILA: OKAY, GREAT. WELL, WHERE DO WE START? LET'S -- I HAVE 1133, WHICH IS A SUPPLEMENTAL BRIEF REGARDING TRIAL EXHIBIT 4621. WE HAD TALKED ABOUT THIS BEFORE. THIS WAS THE -- IS THIS THE JANUARY 25TH LETTER AND THE REPORT I THINK IT IS?
MR. LEACH: THIS IS, YOUR HONOR. THIS IS THE CMS STATEMENT OF DEFICIENCIES --
JUDGE DAVILA: EXCUSE ME.
MR. LEACH: -- WHICH WAS ISSUED ON JANUARY 25TH, 2016. DR. DAS IS THE LAB DIRECTOR AT THE TIME THAT 4621 WAS ISSUED, AND ONE OF HIS RESPONSIBILITIES WAS TO INVESTIGATE THE ALLEGED DEFICIENCIES IN THE 2567, REVIEW DOCUMENTS IN CONNECTION WITH THAT TO RESPOND, AND TO PREPARE THE COMPANY'S RESPONSE. SO HE'S INTIMATELY FAMILIAR WITH THE DOCUMENT. HE TOLD THE GOVERNMENT PREVIOUSLY HE 100 PERCENT AGREES WITH THE DEFICIENCIES THAT WERE FOUND. WE INTEND TO EXAMINE HIM ABOUT A PORTION OF THE 2567, INCLUDING THE COVER LETTER. IN ADDITION TO BEING ADMISSIBLE IN THE CONTEXT OF DR. DAS'S TESTIMONY FOR, YOU KNOW, HIS CORROBORATION OF THE TRUTHFULNESS, WE THINK THE 2567 IS RELEVANT TO THE DEFENDANT'S STATE OF MIND. THE INVESTOR OR THE PATIENT CONSPIRACY COUNT GOES THROUGH 2016. THE DEFENDANT HAS INTRODUCED EVIDENCE FROM MARCH OF 2016 WHERE SHE'S RELAYING THE FINDINGS OF A SCIENTIFIC BOARD THAT SHE CONVENED THAT DOCTORS AND OTHER PEOPLE WITH CONNECTIONS TO THE COMPANY ARE GLOWING ABOUT THE TECHNOLOGY, SAYING THE VACUTAINER WORKS, SAYING THIS IS A LAB IN THE BOX AND IS A GAME CHANGER. AND THE PROFFER IN THE MOMENT WITH GENERAL MATTIS WAS THAT THIS WAS RELEVANT TO THE DEFENDANT'S STATE OF MIND. IF GLOWING REVIEWS ABOUT THE TECHNOLOGY ARE RELEVANT TO HER STATE OF MIND IN MARCH OF 2016, THE CMS REPORT, WHICH IS CRITICAL OF THERANOS'S TECHNOLOGY, IS EQUALLY RELEVANT TO HER STATE OF MIND. SO IT SHOULD COME IN FOR THAT PURPOSE. AND DR. DAS WILL ALSO REVIEW PORTIONS OF THE REPORT AND SAY, YES, I LOOKED INTO THAT AND I AGREE WITH THAT COMPLETELY. IN FACT, THE ISSUE IS EVEN WORSE THAN WHAT IS DESCRIBED HERE.
JUDGE DAVILA: THANK YOU. WILL DR. DAS INDICATE THAT HE SPOKE WITH MS. HOLMES ABOUT THE INFORMATION CONTAINED IN THIS? IN OTHER WORDS, IS THERE SOME EVIDENCE THAT WILL CONNECT MS. HOLMES TO THE DOCUMENT SUCH THAT IT COULD BE INTRODUCED FOR STATE OF MIND?
MR. LEACH: YES. HE WILL TESTIFY THAT HE WAS INSTRUCTED BY MS. HOLMES TO REVIEW THE 2567 AND RESPOND TO IT. I ANTICIPATE THAT'S WHAT HE'LL SAY. IN ADDITION, HE WILL DESCRIBE HOW, IN THE COURSE OF PREPARING THE RESPONSE TO THE 2567, HE RELAYED TO MS. HOLMES WHAT HE WAS FINDING AND WHAT HE INTENDED TO REPORT BACK TO CMS, AND THE COURT HAS FOUND IN THE MOTION IN LIMINE ORDER THAT THE DIALOGUE BACK AND FORTH BETWEEN CMS AND THERANOS IS CLEARLY RELEVANT. AND DR. DAS IS GOING TO SAY NOT ONLY DID MS. HOLMES UNDERSTAND WHAT I WAS FINDING AND WHAT OUR INVESTIGATION OF THE DEFICIENCIES ENTAILED, SHE INSISTED THAT I CHARACTERIZE THIS AS A QUALITY SYSTEMS ISSUE AND NOT AN ISSUE WITH THE DEVICE, WHICH IS WHAT I WAS ACTUALLY SEEING. SO DR. DAS, I ANTICIPATE, WILL TESTIFY MS. HOLMES ASKED HIM TO MINIMIZE THE EXTENT OF THE PROBLEM TO CMS. THAT GOES DIRECTLY TO HER STATE OF MIND, NOT JUST HER KNOWLEDGE OF PROBLEMS, BUT HER DESIRE TO MINIMIZE THEM WHEN CONFRONTED WITH ISSUES.
JUDGE DAVILA: I THINK YOUR PLEADINGS CALL THIS PUSH BACK.
MR. LEACH: YES. AND THOSE ARE HIS WORDS IN OUR PRIOR INTERVIEWS. SO HE WILL CONNECT THE 2567 DIRECTLY TO MS. HOLMES, AND I THINK HER REACTION AND HER DESIRE TO MINIMIZE WHAT IS COMMUNICATED TO CMS IS HIGHLY RELEVANT TO HER STATE OF MIND.
JUDGE DAVILA: OKAY. ALL RIGHT. THANK YOU. THERE'S ANOTHER ISSUE ABOUT THIS, AND I THINK THIS INVOLVES MR. LOOBY, AND WE SPOKE SOME TIME AGO ABOUT THIS AND REDACTIONS IN THIS. I THINK IT -- THERE'S SOME REDACTIONS. MR. LOOBY IDENTIFIED CATEGORIES A, B, AND C, AND I THINK IN YOUR PLEADING 1133 YOU SUGGEST, BASED ON THE COURT'S PRIOR COMMENTS, THAT YOU'RE GIVING NOTICE THAT YOU WANT THE ENTIRETY OF THE DOCUMENT TO COME IN. I THINK WE'LL HAVE TO TALK ABOUT POSSIBLE REDACTIONS. I DON'T KNOW IF YOU WANT TO DO THAT NOW OR BEFORE -- MAYBE WE SHOULD ALLOW MR. WADE TO STATE HIS CURRENT POSITION ON THAT?
MR. LEACH: I'M HAPPY TO HEAR MR. WADE'S CURRENT POSITION ON THAT, YOUR HONOR. I WOULD LIKE TO NOTE THAT IN PREPARING FOR DR. DAS'S DIRECT, THERE ARE ONLY CERTAIN PORTIONS OF THE CMS REPORT THAT I INTEND TO DISPLAY TODAY. I'M HAPPY TO GO THROUGH THOSE IN ADVANCE. I THINK THEY ELIMINATE A LOT OF THE REDACTIONS, BUT NOT ALL OF THEM, BECAUSE I THINK THE ONE THING WE NEED TO BE ABLE TO DISPLAY IS THE -- IT'S LAID OUT BY -- THERE'S A PARTICULAR CITE TO A CODE SECTION, THERE'S A DESCRIPTION OF THE LANGUAGE OF THE CODE SECTION, AND THEN IT SAYS THIS STANDARD OR THIS CONDITION IS EITHER MET OR NOT MET, AND THERE'S A DESCRIPTION OF THE EVIDENCE THAT CMS NOTED. ALL OF THOSE, FOR THESE PARTICULAR PORTIONS, RELATE TO THE EDISON DEVICE, THE TECHNOLOGY THAT THE DEFENDANT WAS HOLDING OUT, SO I DON'T THINK IT RAISES ISSUES WITH ASSAYS THAT AREN'T AT ISSUE OR OTHER ISSUES RAISED IN THE MOTION. SO I ONLY INTEND TO DISPLAY THOSE TODAY, AND I'M HAPPY TO GIVE THE COURT THOSE NUMBERS. I DO THINK THAT THE ENTIRE EXHIBIT IS ADMISSIBLE FOR HER STATE OF MIND, THE EXTENT OF THE ISSUES. SO I THINK WE'VE -- AS THE TRIAL HAS PROGRESSED, WE'VE MOVED A LITTLE BIT PAST, DOES IT REFER TO AN ASSAY THAT'S NOT IN THE BILL OF PARTICULARS OR A PARTICULAR MORE MINOR ISSUE. I DO THINK THE ENTIRETY IS RELEVANT TO HER STATE OF MIND, AND FOR THAT REASON WE DON'T THINK ANY REDACTIONS ARE APPROPRIATE. BUT I'M HAPPY TO PREVIEW THE PARTICULAR PAGES THAT WE WANT TO GO THROUGH TODAY WITH DR. DAS, WHICH I DON'T THINK SHOULD BE REDACTED IN ANY WAY.
JUDGE DAVILA: OKAY. MR. WADE, DO YOU WANT TO HEAR THOSE LIMITATIONS TODAY OR DO YOU WANT TO GO FORWARD WITH --
MR. WADE: YOUR HONOR, I THINK THERE ARE SEVERAL ISSUES HERE. LET ME TRY TO ADDRESS SOME OF THE POINTS THAT THE COURT HAS RAISED AND MR. LEACH HAS RAISED, AND THEN WE CAN GET TO PERHAPS THE PARTICULAR ASPECTS OF THE REPORT ITSELF. I THINK THE SHORT ANSWER TO THAT QUESTION IS WE NEED TO KNOW WHAT IS IN AND WHAT IS OUT IN ORDER TO BE IN A POSITION WHERE WE CAN CROSS-EXAMINE THE WITNESS. SO I UNDERSTAND MR. LEACH HAS SAID THAT HE ONLY INTENDS TO GO INTO CERTAIN PARTS. WE DON'T KNOW WHAT THOSE PARTS ARE. WE DON'T KNOW WHAT IS GOING TO GO IN, SO WE DON'T KNOW HOW TO PREPARE CROSS-EXAMINATION THAT WILL ADDRESS THE RELEVANT PIECES. THAT'S ONE OF THE REASONS WHY, AS THE COURT KNOWS, WE RAISED THIS ISSUE EARLY ON SO WE COULD GET NOTICE AND BE IN A POSITION TO FAIRLY CONFRONT THE WITNESS. I THINK THERE IS A MORE FUNDAMENTAL THRESHOLD ISSUE THAT RELATES TO DR. DAS AND THE CMS CORRESPONDENCE, AND THAT IS WHETHER THAT -- AND THE CMS REPORT, THE 2567.
AS THE COURT KNOWS, THAT WAS THE SUBJECT OF EXTENSIVE MOTIONS PRACTICE DURING THE MOTION IN LIMINE PHASE AND THE SUBJECT OF THE COURT'S ORDER. WE RAISED CONCERNS AT THAT TIME ABOUT HEARSAY, AND ABOUT LAYERED HEARSAY IN PARTICULAR, THAT MANY OF THE ITEMS WITHIN THE REPORT ARE BASED UPON STATEMENTS OF WITNESSES THAT WERE MADE TO THE PEOPLE WHO WROTE THE REPORT, THAT PEOPLE WHO WROTE THE REPORT THEN OBVIOUSLY MADE STATEMENTS WITHIN THE REPORT, DIFFERENT PEOPLE MADE DIFFERENT STATEMENTS. THERE ARE SOME SUBJECTIVE DETERMINATIONS WITHIN THE REPORT THAT WE WERE CONCERNED ABOUT, AND I KNOW THE COURT IN ITS ORDER NOTED THE CONCERN THAT THE -- THE REAL CONCERN THAT A CIVIL VIOLATION HERE COULD CONFUSE THE JURY AND COULD CREATE THE POSSIBILITY THAT, YOU KNOW, MS. HOLMES WOULD BE CONVICTED BECAUSE OF SOME PERCEIVED VIOLATION OF LAW THAT IS A CIVIL VIOLATION. THAT REALLY ISN'T WHAT THIS CASE IS ABOUT.
JUDGE DAVILA: WELL, THAT RELATES MORE TO THE 3217, NOT SO MUCH TO THIS DOCUMENT. BUT GO AHEAD. I JUST WANT TO LET YOU KNOW THAT.
MR. WADE: AND WE NOTE THAT IN RAISING THOSE ISSUES AND THE CONCERNS THAT WE HAD AND THE ABILITY TO CONFRONT THAT EVIDENCE FAIRLY ON BEHALF OF OUR CLIENT, THE GOVERNMENT ADDRESSED THOSE CONCERNS REPEATEDLY BY SAYING IT WAS GOING TO OFFER IT THROUGH ONE OF THE AUTHORS OF THE REPORT SO MS. HOLMES WOULD HAVE A CHANCE TO ADDRESS ALL OF THESE CONCERNS BY CROSS-EXAMINATION OF THE WITNESS ON THE STAND. IT APPEARS THAT THE GOVERNMENT NOW DOES NOT INTEND TO DO THAT, OR AT LEAST INTENDS TO OFFER THIS THROUGH DR. DAS, WHO, OF COURSE, WE CAN'T CROSS-EXAMINE ON THE PREPARATION OF THE REPORT AND ALL OF THE STATEMENTS THAT WERE MADE IN THERE, WHICH CREATES BOTH SIGNIFICANT 403 ISSUES, BUT ALSO CONSTITUTIONAL ISSUES TO THE EXTENT THAT WE'RE NOT ABLE TO CONFRONT THE AUTHOR OF THE REPORT, THE MULTIPLE LAYERS OF HEARSAY, ET CETERA. AND I JUST NOTE AT DOCKET 675 AT PAGES 4, 2 -- 2, 4, 8 -- 8 AND 9, THE GOVERNMENT REPEATEDLY REPRESENTED TO THE COURT IN THE MOTIONS IN LIMINE PRACTICE THAT THESE WITNESSES WOULD BE OFFERED, EITHER SARAH BENNETT OR GARY YAMAMOTO, THAT THEY WOULD TESTIFY AS TO THE CONTENT AND WE WOULD HAVE THE ABILITY TO CROSS-EXAMINE THEM. I DON'T KNOW WHAT THE STATUS OF THAT IS NOW, BUT THEY NOW WANT TO BRING THIS IN THROUGH DR. DAS, WHO, OF COURSE, DIDN'T PREPARE THE REPORT, DOESN'T KNOW WHAT --
JUDGE DAVILA: SO IF ONE OF THOSE WITNESSES TESTIFIED, THAT WOULD ALLEVIATE YOUR CONCERN?
MR. WADE: IT WOULD ALLEVIATE OUR CONCERN. WE DO THINK THAT THAT WITNESS SHOULD ADMIT THE DOCUMENT, SO IF THEY WANT DR. DAS TO TESTIFY AS TO THIS DOCUMENT AS A THRESHOLD MATTER, IT HAS TO COME INTO EVIDENCE WITH AN APPROPRIATE FOUNDATION.
JUDGE DAVILA: SO YOU THINK WHOEVER COULD AUTHENTICATE THE DOCUMENT SHOULD TESTIFY FIRST AND THEN DR. DAS COULD TESTIFY TO IT, AND THAT'S YOUR SUGGESTION TO THE GOVERNMENT ON HOW THEY SHOULD PUT THEIR CASE ON?
MR. WADE: WE DO. WE RAISED THIS ISSUE WITH THE GOVERNMENT. IT'S NOT A SUGGESTION OF TRIAL PRESENTATION. IT'S A 403 ISSUE AND A CONFRONTATION ISSUE, BECAUSE THEY WANT TO PUT IT IN THROUGH A WITNESS WHO DIDN'T PREPARE IT, AND THEY WANT TO GO TO THE END OF IT AND HAVE HIM AGREE WITH CERTAIN THINGS, AND WE DON'T THINK THAT THAT'S APPROPRIATE FOR IT TO COME IN BEFORE THE JURY UNDERSTANDS THE CONTEXT OF THE REPORT, WHAT IT IS, HOW IT WAS PREPARED, THE SIGNIFICANCE OF IT, SO THEY CAN UNDERSTAND HOW IT IS THAT DR. DAS RESPONDED TO IT. BUT DIRECTLY TO THE COURT'S CONCERN, YES, IF THEY PUT UP THAT WITNESS AND WERE ABLE TO CROSS-EXAMINE, WE OBVIOUSLY HAVE THE ISSUES THAT WE RAISED IN THE MOTION IN LIMINE, BUT WE UNDERSTAND THE COURT'S ORDER ON THAT. BUT WE THINK AS A MATTER OF FAIRNESS AND CONSTITUTIONAL PRINCIPLES, WE SHOULD HAVE THE ABILITY TO CONFRONT THAT WITNESS. WE DON'T THINK IT NECESSARILY ELIMINATES THE CONCERN OF PREJUDICE RELATING -- WE DON'T THINK NECESSARILY THINK THAT IT COMPLETELY ADDRESSES THE CONCERNS WITH RESPECT TO THE CONFUSION ON THE CIVIL ISSUES WITHIN THIS CRIMINAL CASE. WE HAVE AN INSTRUCTION, PROPOSED INSTRUCTION, THAT WE HAD SUBMITTED TO THE COURT AT DOCKET 809, PAGE 88, AND I'LL OFFER THAT UP TO THE COURT.
(HANDING.) WE DO THINK IN THESE UNIQUE CIRCUMSTANCES IF THE COURT IS GOING TO ADMIT THIS, THAT THIS IS A CIRCUMSTANCE WHERE THIS INSTRUCTION SHOULD BE, SHOULD BE GIVEN CONTEMPORANEOUS WITH THE EVIDENCE SO THAT THE JURY UNDERSTANDS, YOU KNOW, THE APPROPRIATE LIMITATION OF THE EVIDENCE WITH RESPECT TO THE MATTERS THAT ARE AT ISSUE IN THE CASE. WE THEN HAVE -- BEFORE WE GET TO MR. LOOBY'S ISSUES ON THE PROPOSED REDACTIONS AND WHAT IS IN THE DOCUMENT, THERE ARE A COUPLE OF OTHER ISSUES WITH RESPECT TO MR. DAS. ONE RELATES TO VOIDING AND WHETHER HE IS PERMITTED TO TESTIFY AS TO VOIDING OF THE RESULTS, AND THE OTHER RELATES TO EXPERT TESTIMONY, WHICH WAS THE SUBJECT OF A PRETRIAL MOTION. I KNOW THE COURT REMEMBERS THAT AND THE COURT ISSUED AN ORDER ON THAT. WE'RE SURE THE GOVERNMENT WILL HONOR THAT ORDER AND ONLY OFFER PERCIPIENT WITNESS TESTIMONY. THERE IS ONE REPRESENTATION THAT MR. LEACH JUST MADE THAT GIVES ME, YOU KNOW, SIGNIFICANT PAUSE AS TO THAT. THE -- A JUDGMENT THAT THIS WITNESS IS GOING TO COME IN AND SAY, I AGREE 100 PERCENT WITH EACH AND EVERY FINDING IN THE REPORT IS -- CLEARLY GOES TO, YOU KNOW, EXPERT TESTIMONY. THEY HAVEN'T NOTICED -- THEY HAVEN'T PROVIDED NOTICE THAT THAT WAS AN OPINION THAT HE WAS GOING TO OFFER. IT WASN'T NECESSARY TO HIS JOB. THERE WERE MANY TIMES WITHIN HIS JOB WHERE HE WAS ACTUALLY GOING BACK AND FORTH WITH CMS WITH RESPECT TO PARTICULAR ITEMS WITHIN THE REPORT AND ACTUALLY RAISING DISAGREEMENT WITH ITEMS IN THE REPORT OR SEEKING CLARIFICATION OR TRYING TO RESPOND ON THE COMPANY'S BEHALF.
JUDGE DAVILA: WAS HE HIRED -- AT THE TIME HE WAS HIRED -- WHEN WAS THAT? DECEMBER OF '15, WASN'T IT?
JUDGE DAVILA: AND WAS HE HIRED -- WAS HIS TASK TO ADDRESS THE CMS AND DEAL WITH THE QUESTIONS, AND ALSO DEAL WITH REALIGNMENT OF THE LABORATORY IN COMPLIANCE WITH REGULATIONS? WASN'T THAT HIS TASK?
MR. WADE: THERE WAS CERTAINLY A PART OF THAT, YOUR HONOR. HE WAS ACTUALLY HIRED IN THIS PERIOD BETWEEN -- THERE HAD BEEN AN INSPECTION IN LATE 2015.
JUDGE DAVILA: SEPTEMBER?
MR. WADE: AND THE 2567 WAS ISSUED IN LATE FEBRUARY OF '15. SO HE CAME IN ON A PART-TIME BASIS BEFORE THE NOTICE WAS RECEIVED.
JUDGE DAVILA: AND THEN HE WAS CONTINUED ON AS A FULL-TIME EMPLOYEE UNTIL WHEN WAS IT, 2018? IS THAT WHEN HE LEFT?
JUDGE DAVILA: RIGHT.
JUDGE DAVILA: SURE, RIGHT.
JUDGE DAVILA: SO MY POINT ABOUT THIS, PARDON ME --
JUDGE DAVILA: -- MY POINT WAS WHETHER OR NOT HE -- BECAUSE OF THE REASONS HE WAS HIRED, AND IF HE TESTIFIES, I WAS HIRED TO DO X, Y, Z, PART OF THAT IS, IN RESPONSE TO YOUR QUESTION, CAN HE SAY, I AGREED WITH IT OR NOT? THAT MIGHT BE PART OF HIS JOB TITLE. I DON'T KNOW. WE'LL HAVE TO SEE WHETHER OR NOT THAT EVIDENCE COMES IN. I UNDERSTAND YOUR CONCERN ABOUT MORPHING OVER INTO EXPERT, AND I THINK I WAS VERY SPECIFIC ABOUT THAT IN 798, AND OTHER ORDERS, THAT HE COULD NOT -- 989 ALSO, THAT HE COULD NOT. HE'S GOING TO TESTIFY AS A PERCIPIENT WITNESS, AND HE'S NOT TO TESTIFY UNLESS THE FOUNDATION IS LAID, WHICH I DON'T THINK THAT WOULD HAPPEN. AS YOU POINT OUT, HE HASN'T BEEN IDENTIFIED AS AN EXPERT. YOU HAVE NO NOTICE ABOUT THAT. BUT HE CAN TESTIFY ABOUT A PERCIPIENT WITNESS. WHETHER OR NOT A FOUNDATION IS LAID AS TO THAT QUESTION THAT YOU HAVE CONCERNS ABOUT REMAINS TO BE SEEN. HE MAY BE ABLE TO ANSWER THAT QUESTION BASED ON FOUNDATION. I DON'T KNOW.
JUDGE DAVILA: SURE.
MR. WADE: AND IT HAS PARTICULAR PREJUDICIAL IMPACT IF IT HAPPENS IN FRONT OF THE JURY. IN THIS PARTICULAR CASE, THE CORRESPONDENCE THROUGHOUT 2016 MAKES CLEAR THAT HE IS ENGAGING ACTIVELY WITH CMS TO ADDRESS THESE CONCERNS.
JUDGE DAVILA: RIGHT.
MR. WADE: HE'S CLEARLY COMING TO VIEWS AND RESPONDING TO THE COMPANY, AND WE DON'T HAVE ANY ISSUE WITH THAT. HE'S CLEARLY OF THE VIEW THAT THERE WERE SIGNIFICANT ISSUES WITHIN THE LAB. WE DON'T HAVE ANY ISSUE WITH THAT. THAT'S WHAT HE WAS HIRED TO DEAL WITH. THE CONCERN THAT WE HAVE IS IT'S ONE THING FOR HIM TO GO THROUGH IN REALTIME THE PARTICULAR POSITIONS THAT HE WAS TAKING ON PARTICULAR ISSUES. IT'S ANOTHER THING FOR HIM TO SAY, WHICH I HAVEN'T SEEN ANY CONTEMPORANEOUS EVIDENCE OF, I AGREED 100 PERCENT WITH THE CMS REPORT, AND I'M GOING TO OFFER THIS IN FRONT OF THIS JURY --
JUDGE DAVILA: SURE.
MR. WADE: -- WHEN THERE'S NO INDICATION THAT THAT WAS COMMUNICATED WITH MS. HOLMES THAT HE 100 PERCENT AGREED WITH THE CMS REPORT. THERE'S NO NOTICE FOR THAT OR A BASIS FOR HIS CONCLUSIONS. IN FACT, THE CONTEMPORANEOUS EVIDENCE SUGGESTS OTHERWISE.
JUDGE DAVILA: SO WE'RE TALKING ABOUT THEORETICAL THINGS HERE. HE MAY LAY A FOUNDATION -- PARDON ME, MR. LEACH. BUT THE GOVERNMENT MAY LAY A FOUNDATION FOR THIS. YOU'RE RAISING THIS AS A CONCERN, AND I APPRECIATE IT, AND I THINK IT'S A WAIT AND SEE. LET'S SEE WHAT HAPPENS. I APPRECIATE YOUR CONCERN. HE'S NOT GOING TO BE ABLE TO TESTIFY AS AN EXPERT. I THINK MR. LEACH'S TEAM KNOWS THAT. THEY'VE CONFIRMED THAT IN THEIR RESPONSIVE PLEADINGS, SO I THINK WE CAN EXPECT THAT THEY WILL CONDUCT THE EXAMINATION OF DR. DAS ACCORDING TO THE LIMITATIONS THAT THE COURT HAS IMPOSED ON THEM.
JUDGE DAVILA: YES.
MR. WADE: AND THE GOVERNMENT HAD AN OBLIGATION, I BELIEVE UNDER THE COURT'S ORDER, TO OFFER EVIDENCE OR PROFFER EVIDENCE THAT THIS WAS A LEGAL VIOLATION. AS THE COURT MAY RECALL -- AND TO BE FRANK, THE RECORD IS A LITTLE BIT MIXED ON THIS -- THERE WAS ANOTHER 302 MEMORANDUM OF INTERVIEW THAT -- RELATING TO MR. DAS, OR DR. DAS, THAT THE GOVERNMENT PROVIDED TO US AFTER IT FILED ITS SUBMISSION. THERE'S SOME AMBIGUITY AS TO INITIALLY HE SAID THERE WAS A REQUIREMENT --
JUDGE DAVILA: HE SAID, I WAS REQUIRED TO REDACT OR VOID AND I DID IT BECAUSE I THOUGHT IT WAS THE RIGHT THING. IT SEEMED LIKE A SEMANTIC TYPE ISSUE, WHICH HAS RAMIFICATIONS, I UNDERSTAND. WAS HE REQUIRED OR DID HE DO IT BECAUSE THIS FILTERS INTO HIS CONVERSATION WITH YOUR CLIENT, ET CETERA. SO I THINK I CAPTURE THAT.
MR. WADE: YEAH. AND THAT HAS ISSUES UNDER 407. AND I THINK IT'S A PRETTY IMPORTANT THRESHOLD ISSUE JUST IN TERMS OF IF IT'S A LEGAL REQUIREMENT UNDER 407, AS THE COURT KNOWS FROM PRIOR MOTIONS, THAT'S ONE THING. IF IT'S A MATTER OF DISCRETION, WE -- OF COURSE THERE'S TESTIMONY -- THE GOVERNMENT HAS NOT POINTED TO A LEGAL REGULATION THAT DOES REQUIRE VOIDING OF RESULTS. IT'S UNCLEAR EXACTLY WHAT MR. -- DR. DAS'S VIEW ON THIS IS. THERE'S TESTIMONY FROM THE PEOPLE WHO PREPARED THE REPORT, MR. YAMAMOTO OF CMS WHO SAID THAT HE DIDN'T UNDERSTAND VOIDING TO BE REQUIRED, IT WAS WITHIN THE DISCRETION AS A POSSIBLE WAY TO REMEDY ISSUES. AND SO I THINK THAT'S A PRETTY SIGNIFICANT ISSUE EMBEDDED WITHIN A LOT OF WHAT DR. DAS IS DOING AND IS GOING TO TESTIFY TO. AND SO -- AND I THINK THERE IS NOT A CLEAR PROFFER ON THAT, AND I WONDER WHETHER THAT'S AN ISSUE ON WHICH, OUTSIDE OF THE PRESENCE OF THE JURY, WE OUGHT TO VOIR DIRE THE WITNESS TO ASSESS THAT, OR MAYBE DEFER IT. MAYBE THIS IS AN ISSUE -- LIKE I SAID, IF THE REPORT IS GOING TO COME IN THROUGH A CMS WITNESS, MAYBE CMS CAN APPROPRIATELY DEAL WITH THAT SINCE THEY'RE THE ONES WHO DETERMINE WHAT IS REQUIRED AND WHAT IS NOT. AND THAT'S THE POINT AT WHICH WE THINK THE EVIDENCE OF CMS SHOULD COME IN.
JUDGE DAVILA: OKAY. MR. LEACH?
MR. LEACH: I'D LIKE TO RESPOND TO THE VOIDING POINT FIRST, YOUR HONOR.
JUDGE DAVILA: SURE.
MR. LEACH: 407 APPLIES TO MEASURES. IT DOESN'T APPLY TO AN INVESTIGATION. IT DOESN'T APPLY TO YOUR OWN ANALYSIS. IT DOESN'T APPLY TO INTERNAL THINGS THE COMPANY DOES TO UNDERSTAND ITS PRODUCT, WHICH IS EXACTLY WHAT DR. DAS WAS DOING. WHAT IS LEGALLY REQUIRED IS ONCE DR. DAS FINDS AN ERROR, THERE'S NO DISCRETION UNDER THE CLIA REGS -- I DON'T HAVE IT IN FRONT OF ME -- I THINK IT'S 493.1290 OR 80. I'M SORRY, YOUR HONOR, I DON'T HAVE THE CITE IN FRONT OF ME.
MR. LEACH: I STAND CORRECTED. ONCE THE ERROR IS IDENTIFIED, THERE'S NO DISCRETION TO VOID THE TEST. YOU MUST DO THAT. AND THAT'S THE MEASURE. THAT'S THE ACTION. AND SO DR. DAS WILL SAY, AND I THINK THERE IS SOME SEMANTICS IN IT FROM THE WITNESS'S POINT OF VIEW, BUT HE'LL SAY, AS THE CLIA DIRECTOR, I HAD A RESPONSIBILITY TO GET TO THE BOTTOM OF THIS PROBLEM. I FOUND ERRORS. ONCE I FOUND THE ERROR, I HAD NO CHOICE. I NEEDED TO VOID THE TESTS. SO THERE'S NO 407 ISSUE. AND EVEN IF THERE WERE, IT GOES TO MS. HOLMES'S OWNERSHIP AND CONTROL OF THIS COMPANY. IT GOES, YOU KNOW, TO ISSUES OUTSIDE OF THE LIMITS OF 407. SO I THINK WE HAVE PROFFERED A SUFFICIENT FOUNDATION, OR I THINK YOU'LL HEAR THIS FROM DR. DAS WHEN HE SAYS, I HAD NO CHOICE BUT TO VOID THESE TESTS ONCE I FOUND THE ERROR. WITH RESPECT TO TYING IT TO MS. HOLMES'S STATE OF MIND, YOUR HONOR, THERE'S TWO REASONS WHY IT CONNECTS. FIRST OF ALL, SHE PUSHES BACK.
SHE SAYS, DON'T CHARACTERIZE THIS AS A QUALITY SYSTEM -- OR DON'T CHARACTERIZE THIS AS AN ACCURACY ISSUE TO CMS, CHARACTERIZE THIS AS A QUALITY SYSTEMS ISSUE. AND WHEN SHE TALKS TO LISA PETERSON, SHE AGAIN MINIMIZES THE EXTENT OF WHAT DR. DAS IS FINDING. THAT'S ONE WAY THAT IT CONNECTS TO HER STATE OF MIND. THE SECOND WAY IT CONNECTS IS THAT FOR ALL OF THE REASONS THAT WE TALKED ABOUT WITH THE CMS REPORT, THAT THE DEFENDANT HAS INJECTED EVIDENCE, AND THIS IS AT 7653 AND 1052 WHERE DOCUMENTS HAVE BEEN OFFERED TO SHOW MS. HOLMES'S STATE OF MIND IN 2016 GENERALLY ABOUT THE TECHNOLOGY. AND THE FACT THAT THERANOS IS REQUIRED TO VOID THESE TESTS IN THIS EXACT SAME TIME PERIOD GOES TO HER OVERALL KNOWLEDGE AND STATE OF MIND, WHICH THE DEFENSE HAS PROFFERED AS RELEVANT. SO 407 IS A RED HERRING IN THIS CASE. THEY WERE REQUIRED TO DO THIS. DR. DAS WILL -- TO VOID THE TESTS. HE WILL SAY THAT. AND IT GOES DIRECTLY TO THE ACCURACY OF THE TESTS, AND IT GOES DIRECTLY TO MS. HOLMES'S STATE OF MIND. FOR THAT REASON IT SHOULD COME IN.
JUDGE DAVILA: OKAY. DID YOU WANT TO SPEAK TO ANY OF THE OTHER COMMENTS?
MR. LEACH: I DID, YOUR HONOR. WITH RESPECT TO THE CONFRONTATION ISSUE, I DON'T THINK THAT'S AN ISSUE. THE CMS REPORT IS NOT TESTIMONIAL, AND, YOU KNOW, IT'S NOT PREPARED IN A LAW ENFORCEMENT CONTEXT, SO I DON'T THINK THERE'S A CONFRONTATION ISSUE. THE ENTIRETY OF THE DOCUMENT IS ADMISSIBLE FOR HER STATE OF MIND FOR A NONHEARSAY PURPOSE. AND THEN I THINK IT'S PERFECTLY APPROPRIATE TO SHOW THE DOCUMENT TO DR. DAS -- HE'S INTIMATELY FAMILIAR WITH THIS, THIS WAS A CORE PART OF HIS JOB -- AND TO ASK HIM, DID YOU LOOK AT THIS? WHAT DID YOU DO? DID YOU COME TO THE SAME CONCLUSION THAT IS LISTED HERE? HE'S NO MORE OF AN EXPERT IN THAT CONTEXT THAN SARAH BENNETT OR GARY YAMAMOTO ARE WHEN THEY ARE WRITING DOWN THE WORDS. SO THE FACT THAT CMS LOOKED AT THESE DOCUMENTS IN THE FIRST INSTANCE AND REPORTED THE PERCENTAGE CV OR THE NUMBER OF STANDARD DEVIATIONS THAT ARE AWAY, THAT'S THE SAME THING THAT DR.
DAS IS LOOKING AND HE'S PERFECTLY COMPETENT TO SAY WAS THAT CONSISTENT OR INCONSISTENT WITH DOCUMENTS THAT YOU WERE LOOKING AT. SO I THINK THAT'S AN APPROPRIATE USE OF THE 2567. HE CAN AUTHENTICATE IT, HE GOT IT, AND IT'S BEING OFFERED HERE FOR A NONHEARSAY PURPOSE. CERTAINLY WE COULD AUTHENTICATE IT THROUGH SARAH BENNETT OR GARY YAMAMOTO OR ANOTHER CMS WITNESS, BUT I DON'T THINK WE HAVE TO FOR THE PURPOSES THAT WE'RE USING IT WITH FOR DR. DAS. WITH RESPECT TO THE MULTIPLE LAYERS OF HEARSAY, I THINK THIS ISSUE WAS RAISED AND REJECTED AT THE MOTION IN LIMINE STAGE. BUT I ALSO SUBMIT THAT THE PORTIONS WE'LL BE REFERRING TO WITH DR. DAS, WHICH ARE ON PAGES 45 THROUGH 58 OF THE REPORT, ARE LARGELY THE WITNESS JUST -- OR THE CMS SURVEYOR REPORTING WHAT IS IN DOCUMENTS, NOT RELAYING CONVERSATIONS. BUT I WOULD ALSO ADD, THROUGH THE COURSE OF THIS TRIAL, THE COURT HAS HEARD EVIDENCE ABOUT WHO THE GENERAL SUPERVISOR AND THE TECHNICAL SUPERVISOR AND THE OTHER PEOPLE WITHIN THE LAB ARE. THESE ARE NOT LOWER LEVEL PERSONNEL, YOU KNOW, IN SOME FACTORY MILES AWAY FROM MS. HOLMES. THESE ARE PEOPLE WHO REPORTED DIRECTLY TO THE LAB DIRECTOR UNDER MS. HOLMES'S AND MR. BALWANI'S SUPERVISION. SHE KNEW OF THE INSPECTION IN ADVANCE, AND SHE HELD THESE PEOPLE OUT AS BEING COMPETENT AND CAPABLE TO TALK TO THE ISSUES IN THE LAB. SO I DON'T THINK THAT THERE'S A LAYERED HEARSAY ISSUE.
JUDGE DAVILA: IN EXHIBIT 4 OF YOUR 1133, I THINK YOU HAVE -- EXHIBIT 4 IS -- IT SEEMS LIKE IT'S A SLIDE PRESENTATION THAT MAY HAVE BEEN USED FOR THAT INITIAL MEETING WITH CMS. IS THAT WHAT THAT IS?
MR. LEACH: YES. AND THAT WAS INTRODUCED BY THE DEFENDANT WITH ONE OF THE LAB WITNESSES.
JUDGE DAVILA: AND AT THAT INITIAL MEETING WITH CMS AT THE COMPANY, THE LAB PEOPLE THAT YOU JUST MENTIONED WERE PRESENT AND WERE THERE AS REPRESENTATIVES OF THE COMPANY?
MR. LEACH: MANY OF THEM, YES.
JUDGE DAVILA: ALL RIGHT. THANK YOU. I'M SORRY TO INTERRUPT YOU. GO AHEAD.
MR. LEACH: WITH RESPECT TO DR. DAS AND THE 701 AND 702 ISSUE, AGAIN, I THINK THIS WAS -- NOTHING HAS CHANGED SINCE THE COURT'S ORDER IN 989. DR. DAS IS TALKING ABOUT WHAT HE SAW, HEARD, AND DID IN HIS JOB, AND THE CONCLUSIONS THAT HE COMMUNICATED DIRECTLY TO THE DEFENDANT. HE'S PROVIDING TESTIMONY DIRECTLY IN LINE WITH WHAT THE COURT HAS HEARD FROM DR. ROSENDORFF. HE HAPPENS TO HAVE AN M.D., BUT HE'S -- YOU KNOW, WE'RE NOT ASKING HIM TO REVIEW SOMETHING THAT IS OUTSIDE OF THE COURSE OF HIS DUTIES. HE'S TALKING ABOUT WHAT HE SAW, HEARD, AND DID IN HIS JOB AND COMMUNICATED TO MS. HOLMES, AND THAT'S CLASSIC PERCIPIENT WITNESS TESTIMONY. UNLESS THE COURT HAS FURTHER QUESTIONS, I THINK THAT'S --
JUDGE DAVILA: NO. THANK YOU. THANK YOU.
MR. WADE: YOUR HONOR, IF I COULD MAYBE START WITH THE LAST POINT, WHAT HE SAW, HEARD, AND COMMUNICATED TO MS. HOLMES, I JUST WANT TO MAKE SURE THAT HIS CONCLUSION THAT HE 100 PERCENT AGREED WITH WHAT WAS IN THE CMS REPORT MEETS THE THRESHOLD STANDARD THAT THE GOVERNMENT JUST SAID BEFORE THEY OFFER IT AND IT SPILLS OUT IN FRONT OF THIS JURY, BECAUSE THAT'S THE PART THAT CONCERNS ME. I HAVEN'T SEEN ANY EVIDENCE TO THAT EFFECT, THAT IT MAY BE A LITTLE BIT OF RETROSPECTIVE ANALYSIS OR CONCLUSIONS AFTER, YOU KNOW, THE COURSE OF DEALING. SO ON THE EXPERT ISSUE, THAT'S WHAT CONCERNS US THE MOST. WITH RESPECT TO THE CMS REPORT, THE GOVERNMENT HAS SAID THAT THIS IS EVIDENCE OF WHETHER THE TESTS WERE ACCURATE AND RELIABLE. THEY'VE MADE THAT REPRESENTATION TO THE COURT IN NUMEROUS WRITTEN SUBMISSIONS TO THIS COURT. THEY ALSO SAID THAT WE HAVE THE ABILITY TO CONFRONT THAT EVIDENCE BY CROSS-EXAMINING THE AUTHORS OF THE REPORT. NOW THEY'RE SAYING -- NOW THEY'RE KIND OF PIVOTING AND SAYING IT'S SOMEHOW RELEVANT TO THE STATE OF MIND OF OUR CLIENT, WHICH IS A RATIONALE THAT I DON'T FULLY UNDERSTAND, BUT IT CERTAINLY --
JUDGE DAVILA: IT COULD BE BOTH.
MR. WADE: IT COULD CONCEIVABLY BE BOTH, BUT THERE'S CERTAIN LIMITATIONS ON THE USE OF THE DOCUMENT AND A FOUNDATION THAT IS REQUIRED IF THEY'RE OFFERING IT JUST FOR THE STATE OF MIND OF THE CLIENT. AND THEN THAT WILL GO INTO WHETHER IT'S ACTUALLY RELEVANT TO THE CASE, AND THOSE ARE MR. LOOBY'S ISSUES WITH RESPECT TO PARTICULAR ITEMS. BUT THE ABILITY TO CONFRONT THAT EVIDENCE AND TO AVOID THE CONFUSION THAT IS NECESSARY AS A RESULT OF THAT DOCUMENT REMAINS. THE ENTIRE LITIGATION RECORD REMAINS. THE NEED TO CONFRONT THE MULTIPLE LAYERS OF HEARSAY REMAINS, AND THE GOVERNMENT HAS CONSISTENTLY SAID TO THIS COURT, THE REMEDY TO THAT IS CROSS-EXAMINATION. LET IT IN, PLEASE LET IT IN, THE REMEDY IS CROSS-EXAMINATION. THE COURT AGREED TO LET IT IN, AND NOW THEY WANT TO SHIFT THE TABLE A LITTLE BIT AND PREVENT US FROM FAIRLY CONFRONTING THAT EVIDENCE.
JUDGE DAVILA: BUT IF A WITNESS, AS I ASKED YOU EARLIER, IF ONE OF THE WITNESSES THAT YOU IDENTIFIED, MR. YAMAMOTO OR MS. BENNETT OR ANOTHER PERSON TESTIFIES, THEN YOU'LL HAVE THE OPPORTUNITY TO CROSS-EXAMINE.
JUDGE DAVILA: OKAY.
MR. WADE: WE, WE -- AND I HAVEN'T HEARD THE GOVERNMENT REPRESENT THAT YET. BUT THE -- THOSE CONCERNS WOULD ADDRESS THAT. WE STILL THINK, AS A MATTER OF FAIRNESS, THAT SHOULD COME FIRST, FOR THE DOCUMENT TO COME IN SO THE JURY UNDERSTANDS IT.
JUDGE DAVILA: SURE. I UNDERSTAND THE LOGIC OF THAT. I THINK I CAN SEE THAT. SURE, OKAY.
MR. WADE: THE -- WITH RESPECT TO THE VOIDING ISSUE, YOUR HONOR, THE REGULATION THAT THE GOVERNMENT POINTED TO, WHICH IS 42 CFR 493.1840, WHICH IS WITHIN TRIAL EXHIBIT 7603, WHICH I BELIEVE THE COURT HAS ABOUT SEVEN COPIES UP THERE IN ITS BINDER, THAT REGULATION DOES NOT ACTUALLY ADDRESS THE -- I'M SORRY. IT MIGHT BE -- I'M REFERRING TO A DIFFERENT REGULATION. I APOLOGIZE. I'LL CORRECT THE CITE IN A SECOND. THAT RELATES TO THE NEXT POINT THAT I WANTED TO RAISE. THE REGULATION THAT THE GOVERNMENT HAS POINTED TO, WHICH CAME OUT, I BELIEVE, FOR THE FIRST TIME IN AN INTERVIEW WITH DR. DAS LAST NIGHT, IS A REGULATION THAT RELATES TO IF YOU FIND AN ERROR IN A LAB REPORT, YOU HAVE AN OBLIGATION TO CORRECT THAT ERROR. THAT'S NOT WHAT HAPPENED HERE FOR THE MOST PART. THEY CORRECTED ISSUES IN AN ABUNDANCE OF CAUTION BECAUSE OF CONCERNS THAT THEY IDENTIFIED AS A RESULT OF THIS. THAT PROVISION DOESN'T RELATE TO VOIDING OF TEST RESULTS, IT RELATES TO THE CORRECTION OF A KNOWN ERROR THAT IS IDENTIFIED. HERE, IN AN ABUNDANCE OF CAUTION, BECAUSE OF CONCERNS THAT THEY IDENTIFIED AND TO MAKE CLEAR THAT THE PATIENT SHOULD NOT RELY UPON THESE RESULTS, THEY SAID, WE'RE GOING TO VOID THE RESULTS AND GIVE NOTICE TO DOCTORS AND PATIENTS OF THAT. THAT'S NOT THE LEGAL REQUIREMENT, AND --
JUDGE DAVILA: IS THIS FODDER FOR CROSS-EXAMINATION OF DR. DAS?
JUDGE DAVILA: CAN'T YOU ASK HIM, YOU DID THE WRONG THING? YOU DIDN'T HAVE TO DO THAT? IS THAT YOUR CROSS-EXAMINATION?
MR. WADE: I THINK IT'S A THRESHOLD ISSUE AS TO WHETHER THE EXAMINATION COMES IN AT ALL, THAT'S THE POINT. BECAUSE UNDER 407 IT SHOULDN'T COME IN IF IT IS A SUBSEQUENT REMEDIAL MEASURE. AND IF THE -- DR. DAS CAME IN AND MADE VERY CLEAR THAT IN THE RESPONSE WE WANT TO BE CONSERVATIVE. THERE WAS A LOT OF DISCUSSION BACK AND FORTH ABOUT THE APPROACH THAT SHOULD BE TAKEN. THERE ARE DIFFERENT OPTIONS ON THE TABLE, AND THEY DECIDED TO TAKE WHAT DR. DAS DESCRIBED AS A CONSERVATIVE APPROACH. AND CONTRARY TO THE SUGGESTION OF THE GOVERNMENT, THAT WAS SUPPORTED BY MY CLIENT, BUT IT WASN'T REQUIRED. AND SO THAT'S HOW WE, THAT'S HOW WE END UP IN 407. IT WAS A MATTER OF DISCRETION. IT WAS A REMEDIAL MEASURE. WITH APOLOGIES FOR THE CONFUSION ON THE REGULATION, IT RELATES TO ONE OTHER ISSUE, WHICH IS SOMETHING THAT MR. LEACH TOUCHED UPON, WHICH, AGAIN, I BELIEVE CAME OUT IN INTERVIEWS LAST NIGHT. THERE'S SOME INDICATION THAT THE GOVERNMENT WANTS TO SUGGEST THAT AN OWNER OR OPERATOR WHO AIDED AND ABETTED IN THE VIOLATION OF CLIA OR A CLIA REGULATION CAN BE LIABLE. THAT'S THE PROVISION THAT I MENTIONED BY MISTAKE JUST A SECOND AGO, WHICH IS 493.1840(A)(6). THAT IS NOT THE PROVISION. THE PROVISION FOR AIDING AND ABETTING THE VIOLATION IS NOT THE PROVISION THAT WAS INVOKED IN THE IMPOSITION OF PENALTIES IN THIS CASE. THERE WAS A REVOCATION OF THE LICENSE IN THIS CASE. THERE WAS NO FINDING THAT MS. HOLMES AIDED AND ABETTED AS AN OWNER IN THIS, AND I, I -- THAT WOULD BE AN EXTREMELY PREJUDICIAL STATEMENT TO INJECT IN THIS CASE, AND I BELIEVE AN ERRONEOUS ONE BASED UPON CMS. IT JUST CAME UP FOR THE FIRST TIME LAST NIGHT SO I WANTED --
JUDGE DAVILA: THIS RELATES TO THE 3217, I THINK, DOESN'T IT?
JUDGE DAVILA: AND THAT'S THE -- THAT IS THE DOCUMENT THAT IS THE PENALTY DOCUMENT, IT'S THE JULY 7, 2016, IMPOSITION OF SANCTIONS?
JUDGE DAVILA: AND I THINK WE'RE GOING TO HAVE A SEPARATE CONVERSATION ABOUT THAT. AND YOUR ARGUMENT ON THAT, I THINK, IS 403? THAT'S WHAT YOU TOLD ME PREVIOUSLY, I THINK.
MR. WADE: YEAH, CERTAINLY WITH RESPECT TO SOME OF THE ULTIMATE CONCLUSIONS WITHIN THAT, WITHIN THAT DOCUMENT, YES.
JUDGE DAVILA: SURE. SURE.
MR. WADE: AND IT RELATES TO IT, BUT IT'S SLIGHTLY DIFFERENT. EVEN THERE THE PROPOSED REVOCATION, WHICH ULTIMATELY WAS NOT OF MY CLIENT'S ABILITY TO OPERATE A CLIA LAB, WAS NOT BASED UPON THE PROVISION OF AIDING AND ABETTING A CLIA VIOLATION. THERE'S NO EVIDENCE OF THAT IN THE RECORD. THE GOVERNMENT APPEARS TO HAVE FOUND THAT REGULATION AND PUT IT IN FRONT OF A COUPLE OF WITNESSES RECENTLY, AND I FEAR THAT THEY'RE GOING TO TRY TO OBTAIN TESTIMONY IN CONNECTION WITH THAT WHEN THAT WAS NOT -- THAT IS NOT IN THIS RECORD, AND OBVIOUSLY IT WOULD BE EXTREMELY PREJUDICIAL, AND IT WOULD CLEARLY BE AN EXPERT OPINION IF, IF -- GIVEN THAT DOCTOR -- THIS WAS NOWHERE IN DR. DAS'S SPHERE OF INFLUENCE. SO I WANTED TO RAISE -- THAT'S AN IMPORTANT ISSUE FOR THE DEFENSE AND A NEW ISSUE, AND I WANTED TO RAISE THAT AS WELL.
JUDGE DAVILA: OKAY.
MR. LEACH: IF I COULD RESPOND BRIEFLY, YOUR HONOR, BECAUSE I THINK THERE ARE TWO VERY DIFFERENT ISSUES, AND I THINK ON THAT SECOND ISSUE I MIGHT BE ABLE TO CLEAR UP SOME OF THE DEFENSE'S CONCERN. WITH RESPECT TO THE VOIDING, DR. DAS IS THE AUTHORITY ON THIS. HE WAS THE LAB DIRECTOR AT THE TIME. AND 407 APPLIES TO VOLUNTARY MEASURES WHERE A COMPANY ON ITS OWN IN A MATTER OF BEING CONSERVATIVE DECIDES TO DO SOMETHING. HERE UNDER SERIOUS THREAT OF REGULATORY PRESSURE FROM CMS, DR. DAS CONCLUDED THAT THERE WERE ERRORS IN THE TESTS. ONCE HE CONCLUDED THAT, AND I NOW HAVE THE RIGHT CITE, 493.1291, REQUIRED HIM TO CORRECT THOSE REPORTS AND NOTIFY THE PATIENTS. THE FACT THAT I CAN'T CORRECT THE REPORT TO SAY A VALUE IS Y INSTEAD OF X AND INSTEAD WHOLESALE VOIDS IT IS NEITHER HERE NOR THERE. HE WILL NOT SAY THIS WAS OUT OF AN ABUNDANCE OF CAUTION. HE WILL SAY I -- MY RESPONSIBILITIES AS THE CLIA LAB DIRECTOR CAUSED ME TO INVESTIGATE THESE, I FOUND THESE ERRORS, I WAS REQUIRED TO VOID THEM.
HE'S NOT GOING TO SAY THIS WAS OUT OF AN ABUNDANCE OF CAUTION. 407 APPLIES TO MEASURES, NOT THE INTERNAL ANALYSIS. I THINK I'VE TOUCHED ON THAT POINT. SO I REALLY THINK THERE'S NO 407 ISSUE AND THIS REALLY TIES TO HER STATE OF MIND. WITH RESPECT TO THE SECOND ISSUE, WE HAVE IN EVIDENCE 7603, A HUNDRED PAGES OF CLIA REGULATIONS, AND THE DEFENSE HAS USED THESE CLIA REGULATIONS WITH THE LAB DIRECTOR TO SUGGEST THAT THE BUCK STOPS WITH THE LAB DIRECTOR AND NOBODY ELSE. THIS IS YOUR RESPONSIBILITY AND NOBODY ELSE'S, NOTHING BAD COULD EVER HAPPEN TO THE OWNER OR OPERATOR OF A LAB. ALL WE'VE DONE WITH THE WITNESSES, INCLUDING DR. DAS'S INTERVIEWS AND MS. BENNETT IN INTERVIEWS, IS GO THROUGH THE SAME EXHIBIT THAT IS ALREADY IN EVIDENCE AND NOTE THAT THERE ARE PROVISIONS WHERE OWNERS AND OPERATORS CAN FACE CONSEQUENCES, AND NOTHING MORE. AND IT'S ESSENTIALLY TO REBUT THE SUGGESTION THAT THE ONLY PERSON WITH RESPONSIBILITY HERE, OR POTENTIAL RESPONSIBILITY, IS THE LAB DIRECTOR.
WE HAVE NEVER ASKED THESE WITNESSES, DID ELIZABETH HOLMES AID AND ABET A VIOLATION OF THE CLIA REGULATIONS? IT IS NOT OUR INTENTION TO ASK THAT. BUT THE GOVERNMENT DOES WANT TO REBUT THE FALSE SUGGESTION THAT OWNERS AND OPERATORS OF LABORATORIES HAVE, YOU KNOW, NOTHING TO FEAR FROM A CLIA INSPECTION OR HAVE NO POSSIBLE EXPOSURE AT THE END OF THE DAY BECAUSE I THINK THE DEFENSE HAS CREATED A PICTURE THAT IT'S THE LAB DIRECTOR AND NOBODY ELSE, AND UNDER THE EVIDENCE THAT THEY HAVE SUBMITTED THAT'S JUST NOT THE CASE.
JUDGE DAVILA: THERE HAS BEEN TESTIMONY. DR. ROSENDORFF WAS ON THE STAND FOR A LENGTHY PERIOD OF TIME. AND I THINK THE CROSS-EXAMINATION AT LEAST FOCUSSED A SIGNIFICANT DEAL ON, AS MR. LEACH JUST SAID, YOU WERE RESPONSIBLE, YOU WERE ULTIMATELY RESPONSIBLE. YOU WENT THROUGH THE REGULATIONS WITH HIM, MR. WADE, AND OTHERS, I THINK MAYBE DHAWAN AS WELL, PARDON ME, DR. DHAWAN. SO IT SEEMS LIKE IT'S RELEVANT FOR SOME ISSUE AS TO THAT, JUST AS A, NOT NECESSARILY REBUTTAL, BUT JUST TO PRESENT ANOTHER POSSIBILITY TO THE JURY.
MR. WADE: JUST SO WE'RE CLEAR, I DON'T ACTUALLY THINK -- I DON'T THINK THAT WE WERE MISREPRESENTING ANYTHING. ULTIMATELY --
JUDGE DAVILA: NO, NO, I DIDN'T SAY THAT.
MR. WADE: NO, I KNOW THE COURT WASN'T, BUT COUNSEL WAS. SO I JUST WANT TO MAKE SURE THAT THE RECORD IS CLEAR AND WHY THIS SPECIFIC PROVISION OF AIDING AND ABETTING A VIOLATION, WHICH IS THE SPECIFIC SUB PROVISION THAT THE GOVERNMENT POINTED THE WITNESS TO, IS NOT APPROPRIATE HERE.
JUDGE DAVILA: IS THAT PART OF THE -- IS THIS REGULATION PART OF THE EVIDENCE THAT YOU -- THAT WAS SUBMITTED THAT IS ADMITTED IN THE CASE?
MR. LEACH: YES.
JUDGE DAVILA: RIGHT. WELL, IF IT IS IN EVIDENCE, CAN'T HE CALL ATTENTION TO IT NOW AND SAY WHAT DID THIS SAY? IT SEEMS LIKE IT'S FAIR GAME NOW IF IT'S IN EVIDENCE.
MR. WADE: WELL, YOUR HONOR, HE CAN CALL ATTENTION TO IT, BUT CREATING THE IMPRESSION IN FRONT OF THIS JURY, AGAIN, WITH ALL OF THIS CONFUSION AROUND WHAT IS ALL OF THIS CMS STUFF AND WHAT DOES IT MEAN AND IT'S A CIVIL VIOLATION.
JUDGE DAVILA: RIGHT.
MR. WADE: AND THE CONCERNS ABOUT WHETHER SOMEONE CAN BE CONVICTED AS A RESULT OF THIS. THE PROVISION THAT THEY'RE POINTING TO HAS NOTHING TO DO WITH THIS CASE. THERE WAS NO FINDING, ET CETERA. ALL OF THE PROVISIONS THAT I HAVE POINTED WITNESSES TO WERE THE GUIDING REGULATIONS THAT THEY ADMITTED, EACH AND EVERY ONE OF THEM ARE WHAT FRAMED THEIR OBLIGATIONS FOR ACTING WITHIN THE LABORATORY. I'VE NEVER SUGGESTED THAT THERE'S NO POSSIBILITY OF PENALTIES TO AN OWNER OF THE LAB. WE'VE NEVER SUGGESTED THAT. THERE IS. THEY CAN HAVE THEIR STATUS. IF YOU OWN MORE THAN 5 PERCENT, THEY CAN HAVE THE STATUS REVOKED. THAT DOES NOT MEAN THAT THEY HAVE AN AFFIRMATIVE OBLIGATION TO STEP IN AND OVERRULE A LAB DIRECTOR. IN FACT, THE GOVERNMENT HAS ARGUED THE OPPOSITE. IF THE OWNER WERE TO STEP IN, AND ISN'T QUALIFIED, AND OVERRULES THE LAB DIRECTOR, THAT WOULD BE A DIFFERENT KIND OF PROBLEM. SO TO CREATE THE IMPRESSION THAT THERE IS SOME VIOLATION FOR AIDING AND ABETTING HERE WHEN THERE IS NO SUGGESTION OF THAT AT ALL IN THIS RECORD IS INCREDIBLY PREJUDICIAL.
JUDGE DAVILA: WELL, I UNDERSTAND THAT, BUT I DO THINK THAT THERE MIGHT BE SOME BALANCE HERE. THE CROSS-EXAMINATION, THE VIGOROUS CROSS-EXAMINATION THAT YOU ENGAGED IN WITH THE TWO PRIOR LAB DIRECTORS WERE VERY FOCUSSED ON INDICATING YOU, YOU, YOU, YOU, YOU'RE RESPONSIBLE, YOU'RE RESPONSIBLE, ULTIMATELY YOU'RE RESPONSIBLE. YOU HAD -- DR. ROSENDORFF SAID THAT SEVERAL TIMES IN YOUR CROSS-EXAMINATION AND AS DID DR. DHAWAN. MAYBE IT DOESN'T HAVE TO COME IN AS YOU SUGGEST AS MR. LEACH WON'T BE PERMITTED TO SAY, WELL, SHE'S POTENTIALLY LIABLE AS A COCONSPIRATOR, OR WHATEVER UNDER THAT, I CAPTURE THAT. BUT IT SEEMS LIKE THERE SHOULD BE SOME BALANCING ABOUT THAT ONE POINTING OUT THAT YOU ULTIMATELY WERE RESPONSIBLE. WELL, THE CODE ALLOWS FOR RESPONSIBILITY OF THE OWNER, OR SOMEBODY ELSE, BUT THAT'S NOT AN ISSUE IN THE CASE. BUT JUST TO SOFTEN THE BLOW, I SUPPOSE, OF WHAT YOU'VE SAID, IT SEEMS LIKE THERE'S A BALANCE THAT CAN BE REACHED IN THAT.
MR. WADE: WE'LL SEE WHAT THE GOVERNMENT SUGGESTS. TO THE EXTENT THAT THEY TRY TO CREATE SOME IMPLICATION THAT IT IS A FALSE ONE, THAT OUR CLIENT AIDED AND ABETTED A CLIA VIOLATION, THAT WOULD BE EXTRAORDINARILY PREJUDICIAL.
JUDGE DAVILA: RIGHT. WELL, I DON'T THINK MR. LEACH IS GOING TO DO THAT. I DON'T THINK HE'S GOING TO SAY THAT SHE'S ALSO AIDING AND ABETTING. THAT'S NOT PART OF THE CASE, IS IT, MR. LEACH?
MR. LEACH: IT IS NOT, YOUR HONOR, BUT THE POSSIBILITY OF THE SANCTIONS FOR AN OWNER AND OPERATOR OF THE LAB DIRECTOR ARE IN EVIDENCE HERE AND IT NEGATES, ON SOME LEVEL, THAT THE BUCK STOPS WITH THE LAB DIRECTOR. BUT I WILL NOT IN ANY WAY SUGGEST THAT MS. HOLMES AIDED AND ABETTED A VIOLATION.
JUDGE DAVILA: RIGHT.
MR. WADE: YOUR HONOR, IF I MIGHT PASS UP THE GOVERNMENT'S SUBMISSION WITH RESPECT TO DR. DAS ON THIS VOIDING ISSUE DID NOT INCLUDE AN MOI FROM LAST FRIDAY. IF I MIGHT PASS THAT UP.
JUDGE DAVILA: SURE.
MR. WADE: (HANDING.) JUST SO THAT THE COURT HAS IT, BECAUSE THERE HAVE BEEN REPRESENTATIONS IN THE PLEADINGS AND BY COUNSEL. IF THE COURT TURNS TO PAGE 3 OF THIS, AND THE SECOND PARAGRAPH ON PAGE 3 NOTES, "THE DECISION TO VOID CERTAIN TESTS WAS MADE SOME TIME IN MARCH 2016. DAS INITIALLY SAID THAT HIS DECISION TO VOID THE TEST WAS VOLUNTARY, BUT CLARIFIED THAT IT WOULD HAVE BEEN INCORRECT NOT TO DO SO. BASED ON HIS REVIEW OF DATA, IT WAS NECESSARY TO VOID THE TEST." AGAIN, THIS DOESN'T GO TO -- THIS GOES TO A MATTER OF DISCRETION. THERE'S SOME AMBIGUITY THERE, AND THIS DEMONSTRATES IT, AND THIS IS WHY WE SUGGESTED VOIR DIRING THE WITNESS OUTSIDE THE JURY JUST TO CLARIFY BECAUSE I DON'T THINK IT'S QUITE AS CLEAR AS THE GOVERNMENT IS SUGGESTING WITH RESPECT.
JUDGE DAVILA: AND YOU THINK VOIR DIRE ON THIS PARTICULAR ISSUE AS TO WHETHER OR NOT THIS WITNESS FELT IT WAS VOLUNTARY OR HE HAD AN OBLIGATION, IS THAT WHAT YOU WANT TO CLEAR UP?
MR. WADE: YEAH. WAS THERE A LEGAL OBLIGATION OR WAS IT A VOLUNTARY DISCRETIONARY ACT THAT HE TOOK TO BE CONSERVATIVE IN AN ABUNDANCE OF CAUTION?
JUDGE DAVILA: WOULD THAT BE A FOUNDATIONAL QUESTION THAT MR. LEACH COULD ASK HIM BEFORE THE TESTIMONY?
JUDGE DAVILA: MR. LEACH?
MR. LEACH: THAT'S AN APPROPRIATE APPROACH. I DON'T THINK WE'RE REQUIRED TO DO THAT, BUT WE'RE HAPPY TO DO THAT. AND I WOULD POINT THE COURT TO THE ENTIRETY OF THE PARAGRAPH FROM THE MOI --
JUDGE DAVILA: INVOKING 106, MR. WADE.
JUDGE DAVILA: YES.
MR. LEACH: I THINK A FAIR UNDERSTANDING OF WHAT DR. DAS WAS SAYING HERE IS THAT WHEN I'M -- AS THE LAB DIRECTOR, I'M COMPELLED TO LOOK AT ISSUES, AND WHEN I'M LOOKING AT ISSUES I COULD GO EITHER WAY. BUT ONCE I FIND THE ERROR, I MUST VOID. THAT'S THE TENOR OF WHAT THE COURT WILL HEAR.
JUDGE DAVILA: OKAY. I APPRECIATE ONE AVENUE TO RESOLVE THIS IS A VOIR DIRE OF THE WITNESS, BUT IT SEEMS LIKE IT'S A FOUNDATIONAL QUESTION ALSO THAT AT LEAST YOU PUT MR. LEACH ON NOTICE AND YOU PUT ME ON NOTICE ABOUT, AND THAT MIGHT BE THE MOST EFFICIENT WAY TO GO.
JUDGE DAVILA: RIGHT. I KNOW MR. LOOBY HAS BEEN SCRATCHING HIS FEET BACK THERE AND HE WANTS TO GET UP HERE.
JUDGE DAVILA: YES. WELL, THAT'S THE QUESTION THAT I HAVE ABOUT THESE REDACTIONS. MR. LOOBY, GOOD MORNING.
MR. LOOBY: GOOD MORNING. THANK YOU, YOUR HONOR. SO YOUR HONOR WILL RECALL THAT THE COURT'S ORDER AT DOCKET 989 ON THE DEFENSE'S PRETRIAL MOTIONS ORDERED THE GOVERNMENT TO PROVIDE BOTH THE DEFENSE AND THE COURT WITH ADVANCE NOTICE OF THE PORTIONS OF THE CMS REPORT THAT IT INTENDED TO OFFER.
JUDGE DAVILA: IT DID THAT IN 1133.
MR. LOOBY: YES. AND I SUPPOSE WE GOT OUR NOTICE LAST THURSDAY AT THE END OF COURT THAT THE ANSWER IS ALL OF IT, TWO MONTHS LATER, AND THAT WAS KIND OF THE SUM AND SUBSTANCE OF THE NOTICE. AND THEN -- SO WHERE DOES THAT LEAVE US? WE HAD PROPOSED REDACTIONS ON MULTIPLE GROUNDS, AND TWO OF THEM, I THINK, REMAIN PARTICULARLY IMPORTANT TODAY, AND ONE OF THEM IS RELATED TO THE TESTS NOT IN THE INDICTMENT AND BILL OF PARTICULARS, AND THEN THE SECOND CATEGORY -- AND THAT'S REDACTION CATEGORY A IN OUR PROPOSED REDACTIONS. AND THAT PROPOSED REDACTIONS ARE AT 898-6, AND THE PROPOSED REDACTIONS FOR DOUBLE HEARSAY WHICH IS CATEGORY B AT THAT SAME DOCKET ENTRY. SO THE GOVERNMENT, UNDER THE COURT'S PRETRIAL MOTION IN LIMINE ORDER, HAS TO OFFER A PURPOSE OTHER THAN ACCURACY AND RELIABILITY FOR EVIDENCE PERTAINING EXCLUSIVELY TO TESTS NOT AT ISSUE IN THE INDICTMENT AND BILL OF PARTICULARS. SEVERAL OF THE CMS REPORT CITATIONS FALL DIRECTLY INTO THAT CATEGORY.
TO DATE, I MEAN, I MINED THE PLEADINGS AND THE ARGUMENTS AND TRANSCRIPTS, AND I HAVE NOT HEARD A NONACCURACY AND RELIABILITY RELATED ISSUE UNTIL TODAY WHEN I HEARD THAT IT'S RELEVANT TO STATE OF MIND WHICH KIND OF IS NEW BECAUSE PREVIOUSLY IT WAS TO BE ADMITTED FOR THE TRUTH AND RELATED TO ACCURACY AND RELIABILITY. BUT MY QUESTION WOULD BE STATE OF MIND AS TO WHAT. IF A CITATION IN A CMS REPORT RELATES TO SAY A PROFICIENCY TESTING ISSUE ON AN ASSAY ON AN FDA APPROVED DEVICE THAT IS NOT INVOLVED IN THE CASE, WHETHER OR NOT MS. HOLMES BECAME AWARE OF THAT IN JANUARY 2016 WHEN THE REPORT WAS ISSUED, I DON'T SEE HOW THAT BEARS ON HER STATE OF MIND AS IS RELEVANT TO THE CASE. TO ME THIS IS -- THERE'S PULLED PORTIONS OF THIS REPORT THAT ARE IRRELEVANT UNDER THE COURT'S ORDER, AND WE NEED TO SQUARE THE ORDER ON THE BILL OF PARTICULARS AND THE ORDER ADMITTING THE CMS REPORT. THAT'S WHAT OUR PROPOSED REDACTIONS IN AUGUST WERE MEANT TO DO. WE HOPED IT WOULD START A DIALOGUE OVER WHICH PORTIONS THE GOVERNMENT INTENDED TO OFFER. IT SOUNDS LIKE TODAY THEY HAVE A FEW PAGES PICKED OUT, AND THIS IS THE FIRST THAT WE'RE HEARING ABOUT THAT.
JUDGE DAVILA: THESE ARE THE PAGES MR. LEACH IDENTIFIED EARLIER YOU'RE REFERRING TO? IS THAT RIGHT, MR. LOOBY?
MR. LOOBY: YEAH. AND I HEARD 45 TO 58. I HAVE NOT HAD A CHANCE TO REVIEW THOSE IN PARTICULAR.
JUDGE DAVILA: RIGHT.
MR. LOOBY: BUT, OF COURSE, THE CMS REPORT IS 128 PAGES LONG.
JUDGE DAVILA: WELL, HE'S DONE YOU A FAVOR. HE'S REALLY CUT IT DOWN SIGNIFICANTLY.
MR. LOOBY: YES. I MEAN, I WILL BE INTERESTED TO SEE WHAT THOSE ARE, AND, YOU KNOW, WHETHER OR NOT -- BUT ALSO, MR. LEACH SAID THAT THEY BELIEVED THAT THE ENTIRE REPORT SHOULD COME INTO EVIDENCE. AND WE, OF COURSE, OBJECT TO THAT FOR THE REASONS THAT WE'VE PREVIOUSLY STATED.
JUDGE DAVILA: SURE. SO LET ME SAY -- IT'S A QUARTER AFTER, AND WE'VE ASKED OUR JURY TO COME IN AT 9:30. AND LET ME JUST SAY, I'M GOING TO BE VERY MINDFUL OF TIMING BECAUSE I'D LIKE TO KEEP US ALL ON TRACK HERE, AND WE'RE DOING A GOOD JOB OF THAT. I DO -- I HOPE WE CAN START AT 9:30, AND I THINK I SHOULD GIVE YOU TIME TO REVIEW 45 THROUGH 58 TO SEE. IT'S UNLIKELY THAT WE'LL GET TO THAT THIS MORNING, MR. LEACH? IS THAT FAIR?
MR. LEACH: I'M NOT SURE HOW MUCH MR. WADE HAS WITH DR. SAWYER.
JUDGE DAVILA: I THINK HE TOLD US ABOUT AN HOUR.
MR. LEACH: I THINK AT SOME POINT AFTER OUR FIRST BREAK IT WILL EMERGE.
JUDGE DAVILA: RIGHT. SO WE MAY HAVE TO -- I DO WANT TO GIVE YOU AN OPPORTUNITY TO REVIEW WHAT MR. LEACH HAS SUGGESTED, AND MAYBE THAT WILL CULL SOME OF YOUR CONCERNS.
MR. LOOBY: WELL, YOUR HONOR, I BELIEVE IT'S THE GOVERNMENT'S INTENTION STILL TO ADMIT THE ENTIRETY OF THE REPORT. WHAT I HEARD IS THAT THEY WANTED TO ADMIT THE ENTIRETY OF THE REPORT AND ONLY PUBLISH CERTAIN PORTIONS WITH DR. DAS. SO I THINK REGARDLESS OF WHAT THESE PORTIONS ARE, AND I FOR SURE DO WANT TO REVIEW THEM, AND I APPRECIATE THE OPPORTUNITY FROM THE COURT TO DO THAT. I THINK REGARDLESS OF THAT, I THINK THE ISSUE OF THE ADMISSIBILITY OF THE REPORT WHOLESALE IS STILL GOING TO BE AN ISSUE AND SO WE CAN TAKE THAT UP, YOU KNOW, WHENEVER THE COURT BELIEVES IT'S MOST EFFICIENT. AND THEN THERE ARE OTHER -- THERE ARE TWO OTHER ISSUES THAT I WAS HOPING TO ADDRESS WITH THE COURT THIS MORNING, AND THEY RELATE TO GOVERNMENT EXHIBITS -- AND SO I'LL PREVIEW THEM QUICKLY.
JUDGE DAVILA: SURE.
MR. LOOBY: THEY RELATE TO GOVERNMENT EXHIBITS THAT RELATED TO CMS. THESE ARE IDENTIFIED IN MS. HOLMES'S NOTICE FROM YESTERDAY AT 1134. ONE OF THEM IS 5274, AND THAT IS A SEPTEMBER 26TH DRAFT CMS DOCUMENT ATTACHED IN AN EMAIL FROM A THERANOS LAB DIRECTOR, LISA HELFEND, TO DR. DAS. SO WE HAVE OBJECTIONS TO THAT COMING INTO EVIDENCE. AND THEN THE OTHER BUCKET OF EXHIBITS, AND THEY CAN BE ADDRESSED TOGETHER, ARE ALSO FLAGGED IN OUR NOTICE FROM YESTERDAY, AND THOSE ARE GOVERNMENT EXHIBITS 3144, 4943, 5257, 5260, 5471. AND THESE COLLECTIVELY ARE THE DOWNSTREAM CORRESPONDENCE BETWEEN THERANOS AND CMS RESPONDING TO THE JANUARY 2016 REPORT. THESE DOCUMENTS HAVE SEVERAL ISSUES THAT ARE KIND OF -- THEY SHARE IN COMMON WITH THE CMS REPORT BECAUSE THE CMS REPORT ADDRESSES SO MANY TESTS NOT AT ISSUE AND LAB PRACTICES RELATING TO TESTS NOT AT ISSUE, IT'S OUR POSITION THAT THE CMS REPORT SHOULD BE REDACTED FOR THOSE REASONS, BUT ALSO THOSE REDACTIONS SHOULD CARRY THROUGH TO THE PORTIONS OF THOSE LETTERS THAT SPECIFICALLY ADDRESS THOSE SAME DEFICIENCIES. SO EACH OF THE LETTERS KIND OF MARCHES THROUGH EACH DEFICIENCY AND SAYS, YOU KNOW, THIS IS WHAT CMS SAID, THIS IS THERANOS'S RESPONSE, THIS IS CMS'S RESPONSE. SO IT IS LIKE A SERIATIM BACK AND FORTH, AND SO THEY JUST KIND OF ADD ON TO EACH OTHER. AND THEN THEY ALSO POSE SOME RELEVANCE AND 403 ISSUES THAT I THINK ARE UNIQUE TO THESE LATER LETTERS THAT AREN'T SHARED WITH THE CMS REPORT AND AREN'T COVERED BY OUR PRIOR CONVERSATIONS, ALTHOUGH THEY ARE RELATED TO OUR PRIOR CONVERSATION ABOUT THE JULY 7TH LETTER THAT YOUR HONOR MENTIONED AT 3217 WITH MR. LEACH AND MR. WADE, WHICH IS ACTUALLY AN EXHIBIT THAT THE GOVERNMENT HAS NOT NOTICED AN INTENT TO INTRODUCE THROUGH DR. DAS.
JUDGE DAVILA: 3217?
MR. LOOBY: YEAH. BUT A LOT OF THE SAME ISSUES THAT WE DISCUSSED WITH THAT ARE SHARED WITH THIS OTHER CORRESPONDENCE WHICH IS, YOU KNOW, THIS ISN'T EVIDENCE OF CMS'S FINDINGS NECESSARILY, IT'S AN ONGOING DIALOGUE ABOUT THE ADEQUACY OF THERANOS'S RESPONSES. I HAVEN'T HEARD A RELEVANCE THEORY THAT WOULD SWEEP THOSE IN. I DON'T KNOW PRECISELY WHY THAT IS RELEVANT. BUT IT DOES POSE UNIQUE 403 CONCERNS BECAUSE OF SOME OF THE LANGUAGE THAT WE REVIEWED TOGETHER IN REJECTING THERANOS'S RESPONSES GOES TO WORDS LIKE CREDIBLE, YOU KNOW, WHICH IS THE LINGO OF THE REGULATIONS, BUT HERE IN THE CONTEXT OF A CRIMINAL CASE POSES SOME UNIQUE ISSUES. AND THEN THERE ARE ALSO 702 ISSUES KIND OF WRAPPED UP IN SOME OF THESE REPORTS. AND IN PARTICULAR EXHIBIT 4943 ARE A COMPILATION OF PATIENT IMPACT ASSESSMENTS THAT ARE COMPILED BY THERANOS WITH DR.
DAS'S INVOLVEMENT, AND THEY MARCH THROUGH ON AN ASSAY-BY-ASSAY BASIS, YOU KNOW, HERE ARE SOME OF THE ISSUES THAT WE SPOTTED, AND THEY GET PRETTY TECHNICAL PRETTY QUICK, YOU KNOW, GOING THROUGH TRENDS IN QC DATA ON SPECIFIC DATES, CALCULATIONS BASED OFF OF THAT, EXTRAPOLATIONS AND OPINIONS ABOUT WHAT THAT DATA MEANS. DR. DAS HAS NOT BEEN NOTICED AS AN EXPERT TO WALK THE JURY THROUGH THOSE. SEVERAL OF THOSE PATIENT IMPACT ASSESSMENTS RELATES TO TESTS THAT ARE NOT AT ISSUE IN THE INDICTMENT SO THEY HAVE THAT SAME FLAW AS, YOU KNOW, PORTIONS OF THE CMS REPORT. SO THERE'S A LOT OF THORNY ISSUES, AND I KNOW YOUR HONOR SAW WHEN YOU GOT THE PLEADINGS YESTERDAY, IT'S BIG DOCUMENTS THAT THE GOVERNMENT IS PUTTING IN AND CUMULATIVELY THE IMPRESSION THAT THESE GIVE, EVEN BEYOND THE PARTICULARS, WHICH ARE PRETTY TECHNICAL AND PREJUDICIAL IN THEIR OWN, IS EVIDENCE OF A LOT OF CIVIL KIND OF REGULATORY VIOLATIONS THAT ARE BEING KIND OF PUSHED INTO THE CASE PERHAPS WITHOUT AN ADEQUATE NARRATION OF WHAT IT ALL MEANS TO BE PUT IN FRONT OF THE JURY. AND WE HAVE SERIOUS CONCERNS ABOUT THE UNFAIR PREJUDICE FROM THEM.
JUDGE DAVILA: WELL, THANK YOU. YOUR COLLEAGUE SUGGESTS A PROPOSED JURY INSTRUCTION THAT BE READ CONTEMPORANEOUS WITH ANY OF THE CIVIL REGULATIONS THAT COME IN, OR CERTAINLY HE'S GOING TO ASK. I'M SURE YOUR TEAM IS GOING TO ASK FOR A SIMILAR FINAL INSTRUCTION THAT TALKS ABOUT THE JURY NOT BEING ABLE TO USE ANY CIVIL VIOLATIONS OR REGULATIONS AT ALL IN THEIR DELIBERATION AS TO WHETHER OR NOT YOUR CLIENT HAS VIOLATED ANY CRIMINAL STATUTE, AND I THINK IT PROBABLY WOULD BE APPROPRIATE TO INCLUDE SOME TYPE OF INSTRUCTION IN THE FINAL INSTRUCTIONS TO THAT, TO THAT EXTENT JUST FOR PROPHYLACTIC MEASURES. MR. LEACH, DID YOU WANT TO COMMENT?
MR. LEACH: I HAVEN'T HAD A CHANCE TO FULSOMELY REVIEW THE DEFENSE'S PROPOSED INSTRUCTION, BUT I CAN SAY NOW I DON'T THINK IT SHOULD BE GIVEN IN THE MOMENT, AND THE COURT SHOULD HEAR FULSOME BRIEFING FROM THE PARTIES ABOUT THE PROPRIETARY OF THAT AT THE END OF THE DAY. WITH RESPECT TO THE CMS REPORT, I DON'T MEAN TO ADD TO MR. LOOBY'S BURDEN, BUT I OVERLOOKED ONE ADDITIONAL PAGE OF THE REPORT, WHICH IS PAGE 7 THROUGH 8, AND THESE ARE THE TRIAL EXHIBIT PAGES, BUT THOSE ARE THE ONLY PAGES I INTEND TO DISPLAY WITH DR. DAS. I THINK THE DEFENSE WANTS -- YOU KNOW, THE DEFENSE PROFFERED DOCUMENTS FROM THE MARCH TIME PERIOD WITH GLOWING REVIEWS ABOUT THE TECHNOLOGY AT A HIGH LEVEL, THE NANOTAINER WORKS, WE CAN TEST SMALL SAMPLES RELIABLY. THESE ARE AT 7653 AND 10512. AND IT CAN'T BE A RESPONSE THAT YOU CAN SHOW THE DEFENDANT'S STATE OF MIND WITH THESE PITHY GLOWING REVIEWS BUT NOT THE GRANULAR DETAIL OF WHAT SHE'S GETTING FROM THE CLIA LAB.
IT GOES TO HOW SERIOUSLY SHE TOOK THESE ISSUES, IT GOES TO HER CONTROL OF THE LAB, IT GOES TO WHETHER SHE LEAPT INTO ACTION. AND, YES, SEVERAL OF THEM ARE TECHNICAL AND OF A VARIETY THAT REQUIRES SOME EXPLANATION FROM THE WITNESS, BUT THEY WANT TO PRESENT IT AT A HIGH LEVEL AND AVOID ANY GRANULARITY ON THE ARGUMENT THAT THE GRANULARITY SOMEHOW PREJUDICES THEM. SO THE WHOLE THING IS RELEVANT TO HER SPEED. IF DOCUMENTS GOING TO HER IN MARCH OF 2016 ARE RELEVANT TO HER STATE OF MIND, THIS DOCUMENT IS RELEVANT TO HER STATE OF MIND. WITH RESPECT TO -- I DO INTEND TO STICK TO ASSAYS THAT ARE IN THE BILL OF PARTICULARS. WE'VE NOTICED, YOU KNOW, FOR THE POSSIBILITY OF REFRESHING OR IF THE DEFENSE GOES THERE, CERTAIN EXHIBITS. SO I DON'T INTEND TO PUT IN ALL OF THE LETTERS BACK AND FORTH BETWEEN CMS AND THERANOS, BUT I WOULD SAY THESE AREN'T EXPERT OPINIONS. THESE ARE STATEMENTS BY THERANOS AUTHORIZED BY MS. HOLMES TO TRY TO EXPLAIN WHAT HAPPENED. THEY'RE CLEARLY RELEVANT.
THE ONE I DO INTEND TO INTRODUCE, YOUR HONOR, IS 493, PAGE 9, WHICH IS A PATIENT IMPACT ASSESSMENT RELATING TO THE EDISON DEVICE. THE EDISON DEVICE IS IN THE BILL OF PARTICULARS. THE COURT HAS HEARD LOTS OF TESTIMONY ABOUT THE EDISON DEVICE. AND THIS IS A STATEMENT THAT GOES TO CMS IN AN ATTEMPT TO EXPLAIN WHETHER THE DEVICE WAS OR WAS NOT WORKING IN THE WAY IT WAS SUPPOSED TO AND WHAT THE QUALITY SYSTEMS WERE OR WEREN'T DOING. IT'S AN ADMISSION BY MS. HOLMES AND THERANOS. IT'S NOT AN EXPERT OPINION. NONE OF -- THERE'S NO ISSUES WITH RESPECT TO OTHER ASSAYS, AND THIS IS VERY MUCH A PART OF THE GOVERNMENT'S PROOF WITH DR. DAS. BUT I THINK THE OTHER LENGTHY BACK AND FORTH, I URGE THE COURT TO WAIT AND SEE, BECAUSE I DON'T THINK AT THE END OF THE DAY THE GOVERNMENT IS GOING TO NEED THEM.
MR. LOOBY: AND JUST ONE POINT ON THE ISSUE OF THE ENTIRETY OF THE REPORT BEING RELEVANT TO STATE OF MIND. AND THE GOVERNMENT IS MUSHING TOGETHER REPRESENTATIONS AND STATEMENTS AND FACTS ABOUT THE TECHNOLOGY WITH THE FINDINGS OF THE CMS REPORT, WHICH RELATE TO LAB PRACTICES, AND WHICH COVER THE WHOLE GAMUT OF THE LAB WHICH, OF COURSE, INCLUDED TECHNOLOGY THAT WASN'T MANUFACTURED BY THERANOS. AND SO THERE ISN'T A ONE-TO-ONE CONNECTION BETWEEN KIND OF THE ISSUES IN THE CASE THAT ARE ACTUALLY IN THE CASE AND THE ENTIRETY OF THE CMS REPORT. IT DOES SOUND LIKE THE GOVERNMENT, IN PREPARING ITS WITNESSES, HAS LOCATED THE SPECIFIC D TAGS IN THE CMS REPORT THAT IT WOULD LIKE TO HIGHLIGHT, AND IT HAS LOCATED THE PARTICULAR PATIENT IMPACT ASSESSMENT, BUT IT'S PROPOSED TO PUT INTO EVIDENCE STACKS OF PAPERS WHERE THESE ARE JUST A FEW PAGES OF THEM.
AND I THINK IT PAYS TO BE PRECISE AND TO LOOK AT THE ENTIRETY OF THESE REPORTS AND WHAT THEY SAY AND DON'T SAY BEFORE THEY'RE PUT INTO EVIDENCE AND GO BACK WITH THE JURY FOR DELIBERATIONS. SO, YOU KNOW, I WOULD, I WOULD -- WE MAINTAIN OUR OBJECTION TO PORTIONS OF THE REPORT OTHER THAN THOSE, YOU KNOW, THAT ARE -- WE MAINTAIN OUR OBJECTIONS OF CATEGORIES A AND B IN OUR PROPOSED REDACTIONS AT 898-6. WE STILL MAINTAIN THAT THOSE ARE APPROPRIATE. AND JUST ONE WORD ON THE DOUBLE HEARSAY ISSUE, WHICH I DON'T BELIEVE HAS BEEN SOLVED. THE GOVERNMENT'S ARGUMENT, AS I UNDERSTAND IT, IS ESSENTIALLY BECAUSE THESE LAB STAFF WERE INTERVIEWED ARE WHAT THEY CALL HIGH LEVEL LAB STAFF. I MEAN, IF YOU GO TO THE PRESENTATION THAT WAS IN EVIDENCE THAT WAS GIVEN AT THE START OF THE CMS INSPECTION, I MEAN, I THINK IT'S MORE FAIR TO CHARACTERIZE THEM AS MID LEVEL. MS. HOLMES -- THERE HAS NOT BEEN TESTIMONY OR EVIDENCE THAT MS. HOLMES HAD DAY-TO-DAY SUPERVISION OF THE LAB.
THERE HAS NOT BEEN TESTIMONY FROM THESE PARTICULAR WITNESSES, THESE PARTICULAR LAB STAFF THAT MS. HOLMES CONTROLLED THEIR ACTIVITIES. THERE HASN'T BEEN A FOUNDATION TO CONNECT AN AGENCY RELATIONSHIP BETWEEN MS. HOLMES AND THESE PARTICULAR WITNESSES. THE COURT HAD REJECTED THE GOVERNMENT'S EFFORT TO, TO LUMP IN ALL THERANOS EMPLOYEES AS MS. HOLMES'S AGENTS. IT SEEMS HERE WE'RE JUST KIND OF TRYING TO LOWER THE BAR DOWN THE CORPORATE HIERARCHY, THAT'S THE SENSE OF THE ARGUMENT THAT I GET, BUT THAT'S NOT PARTICULAR ENOUGH TO FORM THE AGENCY LINK. SO I DON'T THINK THEY'VE CLEARED THAT HURDLE YET.
JUDGE DAVILA: AND YOU'RE REFERENCING THE COURT'S 798, THE COURT'S ORDERS AND THE MILS WHICH WAS IN MAY, I THINK MAY 22ND OF THIS YEAR?
MR. LOOBY: CORRECT, YEAH.
JUDGE DAVILA: AND NOW -- OF COURSE WE'VE HAD SOME TESTIMONY. WE'VE HAD TEN WEEKS OF TESTIMONY AND EVIDENCE. PART OF THAT TESTIMONY, IF I RECALL, HAS BEEN WITNESSES, DIFFERENT WITNESSES WHO TESTIFY ABOUT YOUR CLIENT'S CONTROL OF THE LAB, AND WHO IS ALLOWED AND WHO ISN'T, CERTAIN PERSONNEL THAT WERE PERMITTED TO GO IN THERE. AND MY SENSE FROM THE GOVERNMENT'S PLEADING IS THAT THERE IS A STRONG INFERENCE THAT ANYBODY WHO WAS THERE FOR THE CMS EVENT, WHICH WAS AN IMPORTANT EVENT IN THE LIFE OF THE COMPANY, WAS THERE WITH KNOWLEDGE AND CONSENT OF THE CEO OF THE COMPANY SUCH THAT THAT DECISION WAS MADE TO ALLOW THEM TO BE THERE FOR THAT IMPORTANT EVENT. AND I THINK WHAT MR. LEACH, I THINK WHAT I AM INFORMED FROM HIS PLEADINGS, SUGGESTS IT'S A FAIR INFERENCE, IF NOT CIRCUMSTANTIAL EVIDENCE, THAT THEY WERE THERE WITH HER IMPRIMATUR.
MR. LOOBY: WELL, THE TECHNICAL SUPERVISOR, THE GENERAL SUPERVISOR, AND THE QA/QC MANAGER OF THE THERANOS CLIA LABORATORY, SO THEY WOULD BE OBLIGATED AND EXPECTED TO BE THERE TO ANSWER CMS -- THEY WORK IN THE LAB, AND THE CMS INSPECTION IS AN INSPECTION OF THE LAB. SO I THINK IT'S NOT THE CORRECT QUESTION TO ASK WAS -- WERE THEY THERE WITH MS. HOLMES'S PERMISSION? OF COURSE THEY ARE EMPLOYEES OF THERANOS. BUT THE QUESTION IS WHETHER OR NOT MS. HOLMES -- THEY'RE AGENTS OF MS. HOLMES AS THEY WERE ACTING ON THAT DAY? AND I THINK THERE HASN'T BEEN TESTIMONY ABOUT MS. HOLMES AND A PRESENCE IN OR INVOLVEMENT IN THE LAB IN THE 2014, 2015 PERIOD. I MEAN, THE LAB DIRECTOR AT THE TIME TESTIFIED THAT HE HADN'T MET MS. HOLMES. SO I THINK THERE'S A GAP THERE.
JUDGE DAVILA: OKAY. MR. LEACH, DO YOU WANT TO COMMENT ON THAT?
MR. LEACH: THERE ARE TEXT MESSAGES, YOUR HONOR, WHERE MS. HOLMES IS PRAYING DURING THE SEPTEMBER 2015 CMS EXAMINATION. THE DEFENSE -- OR AFTER THE COURT DENIED A MOTION IN LIMINE TO EXCLUDE A DOCUMENT THAT MR. BALWANI HANDED TO CMS DURING THE INSPECTION, AFTER THE COURT DENIED THAT MOTION, THE DEFENSE INTRODUCED THAT DOCUMENT THROUGH DR. DHAWAN. THERE'S AMPLE EVIDENCE THAT MS. HOLMES WAS AWARE OF AND DIRECTING AND SENDING OUT AGENTS FOR THE PURPOSE OF THE CMS INSPECTION, WHICH WAS, AS THE COURT NOTES, AN IMPORTANT EVENT IN THE COMPANY. I DON'T SEE A DOUBLE HEARSAY PROBLEM HERE, AND I DON'T HAVE ANYTHING MORE TO ADD THAN WHAT WE HAVE IN OUR --
JUDGE DAVILA: YOU SUGGEST THAT AT LEAST FOR PURPOSES OF OVERCOMING A HEARSAY OBJECTION THIS -- THAT TESTIMONY OR THOSE OBSERVATIONS ARE ADMISSIBLE UNDER AN AGENCY THEORY?
MR. LEACH: YES, YOUR HONOR.
JUDGE DAVILA: OKAY. OKAY.
MR. LOOBY: YOUR HONOR, UNDER THE TEST FOR AGENCY OF AUTHORIZATION AND CONTROL OF THE EMPLOYEES'S ACTIONS, I DON'T THINK THERE IS A FOUNDATION THERE. I THINK WHAT MR. LEACH JUST DESCRIBED IS MS. HOLMES AWARENESS OF THE CMS INSPECTION, HER HOPES THAT IT WOULD GO WELL, HER PRAYERS THAT IT WOULD GO WELL. I MEAN, THAT DOESN'T CONNECT TO WHETHER OR NOT THESE PARTICULAR LAB EMPLOYEES RESPONDED TO MS. HOLMES, REPORTED TO MS. HOLMES, INTERACTED WITH MS. HOLMES, THAT SHE AUTHORIZED SPECIFIC REPRESENTATIONS THAT THEY WOULD HAVE MADE DURING THE INSPECTION. THEY'RE EMPLOYEES OF THE LAB, AND THEY WERE BEING INTERVIEWED AS EMPLOYEES OF THE LAB.
JUDGE DAVILA: OF THERANOS?
MR. LOOBY: YES.
JUDGE DAVILA: MR. LEACH?
MR. LEACH: I HAVE NOTHING FURTHER, YOUR HONOR.
JUDGE DAVILA: OKAY. I'M INFORMED THAT IT'S GOING TO TAKE US TEN MINUTES TO REBOOT OUR SYSTEM TO ALLEVIATE SOME OF THE PROBLEMS THAT WE'VE HAD THIS MORNING, ELECTRICAL PROBLEMS. I'LL STEP DOWN, AND WE'LL GET THAT STARTED. I THINK WE'RE GOING TO BREAK AT ABOUT 11:00 O'CLOCK AND THEN AGAIN AT 1:30. AND I THINK I TOLD YOU I HAVE SOMETHING FROM 12:30 TO 1:00. SO WE'LL TRY TO INCORPORATE ALL OF THAT IN TODAY. AND I THINK WE'RE GOING UNTIL 4:00 TODAY.
MR. LOOBY: AND, YOUR HONOR, FOR EXHIBIT 5274, I'M NOT SURE -- THIS IS THE SEPTEMBER 2016 DRAFT CMS DOCUMENT. I'M NOT SURE IF THE GOVERNMENT INTENDS TO OFFER THAT INTO EVIDENCE. BUT EITHER AT A BREAK OR AT A SIDE-BAR WE MAY WANT TO DEVOTE A FEW MINUTES TO DISCUSSING THAT.
JUDGE DAVILA: OKAY. THANK YOU. OKAY. ANYTHING FURTHER?
MR. LEACH: THANK YOU, YOUR HONOR. NOT FROM THE GOVERNMENT.
COURT CLERK: COURT IS IN RECESS.
(RECESS FROM 9:35 A.M. UNTIL 11:11 A.M.)
(JURY IN AT 11:11 A.M.)
JUDGE DAVILA: ALL RIGHT. THANK YOU. WE ARE ON THE RECORD IN THE HOLMES MATTER. ALL COUNSEL ARE PRESENT. MS. HOLMES IS PRESENT. OUR JURY IS PRESENT. GOOD AFTERNOON, LADIES AND GENTLEMEN.
(LAUGHTER.)
JUDGE DAVILA: I WANT TO TELL YOU, WE'VE HAD SOME TECHNICAL PROBLEMS, AND OUR VIDEO SYSTEM IS COMPROMISED. YOUR SCREENS WILL NOT BE WORKING. THE SCREENS IN FRONT OF ALL OF US ARE NOT WORKING. WE HAVE, DURING THE BREAK, COUNSEL HAVE TRIED TO BE EFFICIENT AND GOOD AND TRY TO WORK OUT COMPROMISES. WHAT YOU SEE ON THE SCREEN IN FRONT OF YOU IS THE DEVICE THAT IS PROJECTING ON THE WALL. AND AFTER DOING VARIOUS TESTING, I THINK THE PARTIES HAVE AGREED THAT THIS IS PROBABLY THE BEST THAT WE'LL BE ABLE TO DO TODAY. I'M INFORMED THAT TO PROPERLY CORRECT THE ISSUE, WE WILL NEED TO SHUT THE SYSTEM DOWN, AND THEY'RE GOING TO HAVE TO DO THAT AT THE END OF TODAY. SO WHAT I WOULD LIKE TO DO TODAY, AFTER I ASK YOU A QUESTION ABOUT YOUR WEEKENDS AND WHETHER OR NOT YOU'VE HAD AN OCCASION TO SEE ANYTHING OR TALK TO ANYONE OR COME ACROSS ANYTHING TO DO WITH THIS CASE, WHAT WE WILL DO IS TURN THE LIGHTS DOWN, AND WE'VE THOUGHT ABOUT TURNING SOME OF THESE LIGHTS OFF SUCH THAT THIS SCREEN CAN BE MORE VISIBLE. AND WHAT I'D LIKE TO DO IS TO ASK YOU TO LOOK AT THIS AND LOOK AT OUR SCREEN HERE, AND TELL ME IF THIS PRESENTS ANY PROBLEMS AS FAR AS VIEWING ANY OF THE EXHIBITS. SO THAT'S WHAT WE'RE GOING TO DO FIRST BEFORE WE RESUME TESTIMONY. SO AS TO MY QUESTION AND THE ADMONITION, HAS ANYONE COME ACROSS ANYTHING, DISCUSSED WITH ANYONE, HEARD, READ, OR LISTENED TO ANYTHING ABOUT THIS CASE SUCH THAT YOU THINK YOU SHOULD INFORM ME? IF SO, PLEASE RAISE YOUR HANDS. I SEE NO HANDS. THANK YOU VERY MUCH AGAIN. SO WHAT WE'LL DO NOW, COUNSEL, WE'LL TURN DOWN THE LIGHTS TO A LEVEL THAT YOU AGREED THAT WE'D LOOK AT, AND THEN I'LL ASK THE JURORS WHETHER OR NOT THEY'RE ABLE TO SEE THE EXHIBITS. MS. KRATZMANN.
COURT CLERK: YES, YOUR HONOR.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: I'LL GIVE THE JURORS A COUPLE OF MINUTES TO LOOK AT THAT. DOES THAT PRESENT ANYONE ANY ISSUE TO SEE AND UNDERSTAND, TO READ AND COMPREHEND AT LEAST THIS DOCUMENT THAT WE HAVE DISPLAYED HERE AS A SAMPLE? IF SO, IF THAT'S A PROBLEM, IF YOU COULD PLEASE RAISE YOUR HAND. AND THIS IS IMPORTANT. IF YOU'RE NOT ABLE TO SEE THIS, THEN WE'LL HAVE TO DO SOMETHING ELSE. IT'S IMPORTANT THAT THE JURY BE ABLE TO SEE AND FOLLOW THE EXHIBITS AS THE TESTIMONY IS GIVEN. YES.
JUROR: NO, I'M GOOD.
JUDGE DAVILA: THAT'S A THUMBS UP?
JUROR: YOUR HONOR, IF I COULD RETURN TO THE ROOM AND GET A PAIR OF GLASSES, I WILL BE ABLE TO SEE THAT.
JUDGE DAVILA: WHY DON'T WE DO THAT. AND THANK YOU FOR THAT.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: ALL RIGHT. THE RECORD SHOULD REFLECT THAT OUR JUROR HAS RETURNED WITH GLASSES. IS THAT WORKING OKAY?
JUROR: YES.
JUDGE DAVILA: ALL RIGHT. IS THERE ANYONE HAVING A PROBLEM WITH THIS, NOT JUST VIEWING THIS, BUT ANYTHING ABOUT THE LIGHTING IN THE COURTROOM THAT WILL CAUSE A JUROR ANY IMPEDIMENT AS TO BE ABLE TO FOLLOW THE EVIDENCE, BOTH THE SPOKEN EVIDENCE AS WELL AS THE VISUAL EVIDENCE? DOES ANYONE FEEL THAT THE CURRENT CONDITION WILL NOT SERVE THEM THE OPPORTUNITY TO ACCOMPLISH THAT? IF SO, RAISE YOUR HAND. I SEE NO HANDS. OKAY. ALL RIGHT. THANK YOU. LET ME APOLOGIZE, LADIES AND GENTLEMEN. I JUST WANT TO BE -- I'M VERY EMBARRASSED THAT OUR COURTROOM HAS HAD THESE PROBLEMS. WE HAD WATER OUTAGES TWO WEEKS AGO AND NOW OUR SYSTEM IS, FOR SOME REASON, NOT FUNCTIONING. I APOLOGIZE TO YOU AS MEMBERS OF THE PUBLIC AS PART OF THIS TRIAL, AND COUNSEL AND ALL OF THE PARTIES HERE. I'M SORRY, THIS IS NOT SUPPOSED TO HAPPEN. WE SHOULD NOT HAVE THESE DISRUPTIONS. WE'VE LOST VALUABLE TIME THIS MORNING. BUT MORE THAN THAT, IT'S REGRETTABLY A DISPLAY OF ISSUES WITH OUR COURT THAT I'M NOT PROUD OF. AND WE'LL LOOK INTO THIS. I'LL LOOK INTO THIS AND SEE WHAT WE CAN DO TO CORRECT THIS TO MAKE YOUR TIME WITH US A LITTLE MORE ENJOYABLE. SO THANK YOU FOR THAT. IF AT ANY TIME A JUROR DOES HAVE AN ISSUE WITH FOLLOWING, TRACKING, PLEASE RAISE YOUR HAND AND LET US KNOW SO I CAN TAKE APPROPRIATE ACTION. LET ME TELL YOU SCHEDULE WISE, I HOPE YOU RECALL WE'RE GOING TO TAKE A BREAK FROM 12:30 TO 1:00 O'CLOCK, I THINK. I HOPE THAT WILL WORK. AND THEN WE'RE GOING UNTIL 4:00 O'CLOCK TODAY. SO WE'LL PROBABLY HAVE ANOTHER BREAK PUT IN THERE IN THE AFTERNOON SOMETIME. ALL RIGHT. THANK YOU. ANYTHING FURTHER, MR. SCHENK?
MR. SCHENK: NO, YOUR HONOR.
MR. DOWNEY: NO, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. LET ME ASK, DO BOTH SIDES CONSENT TO PROCEEDING IN THIS FASHION?
MR. SCHENK: YES, WE DO.
MR. DOWNEY: WE DO, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU VERY MUCH. LET'S SEE. WE HAVE A WITNESS. I THINK, MR. WADE, HAVE YOU -- YOU HAVE SOME QUESTIONS STILL FOR MS. SAWYER?
JUDGE DAVILA: ALL RIGHT. WE'LL BRING MS. SAWYER IN.
COURT CLERK: DID YOU WANT ME TO TURN ON THE LIGHTS FOR NOW, YOUR HONOR?
JUDGE DAVILA: WHY DON'T WE TURN THEM ON UNTIL WE HAVE AN EXHIBIT? COUNSEL, DO YOU WANT A LIGHT FOR THE LECTERNS?
JUDGE DAVILA: OKAY. MS. SAWYER, GOOD AFTERNOON. PLEASE COME FORWARD. THANK YOU. IF YOU COULD RESUME THE STAND AGAIN, PLEASE. MAKE YOURSELF COMFORTABLE AGAIN. DR. SAWYER, WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME AGAIN FOR THE RECORD, PLEASE.
LYNETTE SAWYER: LYNETTE SAWYER.
JUDGE DAVILA: THANK YOU. I REMIND YOU THAT YOU'RE STILL UNDER OATH. AND YOU CAN REMOVE YOUR MASK AS YOU DID LAST WEEK WHEN YOU TESTIFIED IF YOU WOULD LIKE.
LYNETTE SAWYER: THANK YOU.
(GOVERNMENT'S WITNESS, LYNETTE SAWYER, WAS PREVIOUSLY SWORN.)
JUDGE DAVILA: THANK YOU.
MR. WADE: YOUR HONOR, WOULD YOU LIKE TO UPDATE THE WITNESS ON THE CONDITIONS THAT WE'RE GOING TO BE WORKING UNDER, OR WOULD YOU LIKE ME TO DO THAT?
JUDGE DAVILA: WELL, NO. LET ME TELL YOU, DOCTOR, WE'VE HAD SOME TIME TODAY AND WE'VE TRIED TO SOLVE A PROBLEM THAT IS UNSOLVABLE. OUR VIDEO FOR SOME REASON HAS CHOSEN TODAY TO GO OUT.
LYNETTE SAWYER: OKAY.
JUDGE DAVILA: I'M SURE THIS IS A CASE OF FIRST IMPRESSION TO YOU. SO WHAT WE'RE GOING TO DO IS TO GO FORWARD TODAY. WE PUT THIS LITTLE LAMP NEXT TO YOU. IF THERE ARE EXHIBITS THAT COUNSEL ARE GOING TO USE, WE'RE GOING TO DIM THE LIGHTS AND PROJECT THEM ON THE SCREEN UP HERE. YOU WON'T HAVE BENEFIT OF THE TELEVISION MONITOR THERE. YOU'LL HAVE TO LOOK AT THAT SCREEN.
LYNETTE SAWYER: OKAY.
JUDGE DAVILA: SO IF AT ANY TIME YOU'RE UNABLE TO SEE THAT SCREEN, YOU SHOULD LET US KNOW. LET ME KNOW, PLEASE --
LYNETTE SAWYER: OKAY.
JUDGE DAVILA: -- SO WE CAN TAKE ANY OTHER ACTION. OR IF ANY OF THIS IS DISRUPTIVE TO YOUR ABILITY TO PARTICIPATE, YOU NEED TO LET ME KNOW AND WE'LL TAKE CORRECTIVE ACTIONS.
LYNETTE SAWYER: OKAY.
JUDGE DAVILA: FOR THE TIME BEING, I'M JUST GOING TO LEAVE THAT CHARMING LAMP THERE AND LEAVE IT ON, AND HOPEFULLY IT WILL BE OF SOME ASSISTANCE. THANK YOU. COUNSEL.