Erika Cheung — Cross/Redirect (Continued)
887 linesCROSS-EXAMINATION (RESUMED) BY MR. WADE:
ERIKA CHEUNG: GOOD MORNING.
ERIKA CHEUNG: I'M HAVING A LITTLE TROUBLE HEARING YOU.
ERIKA CHEUNG: YES.
MR. WADE: THANK YOU. I WOULD LIKE TO PICK UP WITH SOME QUESTIONS TODAY ABOUT SOME OF YOUR WORK IN THE CLIA LAB AT THERANOS.
ERIKA CHEUNG: OKAY.
MR. WADE: AND DO YOU RECALL YOUR DISCUSSION ABOUT THE EDISON DEVICE, YOU TALKED ABOUT HOW THERE WAS SOFTWARE ON THE EDISON SYSTEM?
ERIKA CHEUNG: YES.
MR. WADE: AND WAS THERE A SPECIAL TEAM OF PEOPLE WHO WERE DEDICATED TO DOING THE SOFTWARE PROGRAMMING FOR THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: ONE OF THE PEOPLE IN CHARGE OF DOING THE SOFTWARE WAS MICHAEL CRAIG, C-R-A-I-G, BUT I DON'T KNOW --
ERIKA CHEUNG: HE WAS THE ONE WHO I INTERFACED WITH THE MOST.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO ALCHEMIST WAS A SOFTWARE DATABASE, AND ESSENTIALLY WHEN THE EDISON DEVICES HAD FINISHED COMPLETING A TEST OR A RUN, IT WOULD UPLOAD ALL OF THE INFORMATION TO ALCHEMIST, WHEREIN THAT INFORMATION WOULD BE DOWNLOADED AND GATHERED BY PEOPLE IN THE RESEARCH AND DEVELOPMENT TEAM OR IN THE CLINICAL LAB FOR A PERIOD OF TIME. EVENTUALLY THAT WAS AUTOMATED, BUT THERE WAS A PERIOD OF TIME WHERE THAT WAS THE CASE FOR THE CLINICAL LAB THAT IT WAS PULLED FROM ALCHEMIST.
ERIKA CHEUNG: IT WAS -- THE RAW DATA OR THE PATIENT DATA?
ERIKA CHEUNG: THE PATIENT DATA WENT INTO A LABORATORY INFORMATION SYSTEM.
ERIKA CHEUNG: BUT -- SORRY. THAT WAS MANUALLY ENTERED WHEN I WAS WORKING THERE. IT WASN'T AUTOMATED INTO THE SYSTEM.
ERIKA CHEUNG: LABORATORY INFORMATION SYSTEM IS A DATABASE THAT YOU KEEP ALL OF THE PATIENT RECORDS AND PATIENT INFORMATION, THE CLINICIAN INFORMATION, THE PATIENT RESULTS, YOU'LL STORE QUALITY CONTROL INFORMATION, THE TECHNICIANS IN CHARGE OF RUNNING THE PATIENT SAMPLE, THE CLINICAL LAB SCIENTIST WHO WOULD BE RESPONSIBLE FOR REVIEWING THE INFORMATION. IT'S SORT OF A COMPREHENSIVE DATABASE THAT YOU UTILIZE IN ORDER TO RESULT OUT CLINICAL DIAGNOSTIC RESULTS, AND THAT'S WHAT WE USED IT FOR AT THERANOS AS WELL.
ERIKA CHEUNG: ALL OF THE CLINICAL DATA, YES.
MR. WADE: AND SO WOULD THAT -- IF YOU HAD ACCESS TO THAT INFORMATION, WOULD THAT GIVE YOU A SENSE OF WHEN A PARTICULAR TEST STARTED RUNNING IN THE LAB?
ERIKA CHEUNG: SAY THAT ONE MORE TIME.
MR. WADE: IF YOU HAD ACCESS TO DATA WITHIN THE LAB INFORMATION SYSTEM, WOULD THAT TELL YOU WHEN A PARTICULAR TEST STARTED TO GO LIVE IN THE LAB AND BE USED ON PATIENT TESTING?
ERIKA CHEUNG: SO CAN I GIVE AN EXAMPLE JUST FOR CLARIFICATION?
ERIKA CHEUNG: SO ARE YOU SAYING -- SAY, FOR EXAMPLE, WE HAD A NEW EDISON TEST THAT WE WERE RUNNING, WOULD IT BE LOCATED IN THE LABORATORY INFORMATION SYSTEM WHETHER THAT TEST WENT LIVE?
MR. WADE: LET ME ASK IT A DIFFERENT WAY. WHOEVER WHO WAS THE FIRST PATIENT WHO RECEIVED THE TEST, YOU WOULD HAVE THAT INFORMATION IN THE LABORATORY INFORMATION SYSTEM; RIGHT?
ERIKA CHEUNG: CAN YOU REPEAT THAT ONE MORE TIME?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND SO AT SOME POINT THAT DEVICE STARTED RUNNING VITAMIN D IN THE LAB. AND IF WE WANTED TO FIGURE OUT WHEN THAT WAS, WE COULD LOOK AT THE LABORATORY INFORMATION SYSTEM AND FIND THE FIRST RESULT FOR AN EDISON DEVICE AND A PATIENT WHO GOT A VITAMIN D?
ERIKA CHEUNG: IN THE LABORATORY INFORMATION SYSTEM?
ERIKA CHEUNG: THERE WAS A PERIOD OF TIME WHERE, NO, THAT INFORMATION WAS NOT FOUND THERE. IT WAS FOUND IN SPREADSHEETS.
ERIKA CHEUNG: BUT THEN IT MIGRATED INTO A LABORATORY INFORMATION SYSTEM AFTERWARDS. BUT THAT WAS AT THE TAIL END, AT LEAST FROM MY EXPERIENCE WORKING AT THERANOS, THE TAIL END OF ME WORKING THERE.
MR. WADE: AND I WANT TO BACK UP AND SET A LITTLE BIT OF TIMING FRAME OF REFERENCE FOR THE RECORD HERE. THE LABORATORY, CLINICAL LABORATORY AT THE TIME THAT YOU STARTED AT THE COMPANY WAS COLLECTING AND PROCESSING SAMPLES FROM, FROM A COLLECTION CENTER IN PALO ALTO; IS THAT RIGHT?
ERIKA CHEUNG: IT WAS THE WALGREENS IN PALO ALTO, YES.
ERIKA CHEUNG: THERE WAS ONE LOCATION IN PALO ALTO, AND THEN WE HAD JUST STARTED TO OPEN UP A LOCATION IN ARIZONA.
ERIKA CHEUNG: I THINK IT WAS LATER THAN THAT, BUT IT WAS AROUND DECEMBER, JANUARY MORE SO THAN NOVEMBER.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: EITHER TWO OR THREE.
MR. WADE: AND I THINK YOU TESTIFIED ABOUT THE SEVEN TESTS THAT WERE RUN ON THE EDISON DEVICE DURING YOUR TIME AT THE COMPANY.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: TST? YES. AND THERE WERE KIND OF A RANGE OF OTHERS, BUT SOME OF THEM WEREN'T ACTIVE.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND DO YOU RECALL THE DATE ON WHICH YOU STARTED RUNNING THE VITAMIN D ON THE EDISON?
ERIKA CHEUNG: SAY THAT ONE MORE TIME.
ERIKA CHEUNG: YEAH.
MR. WADE: DO YOU RECALL APPROXIMATELY THE DATE ON WHICH YOU STARTED RUNNING THE VITAMIN D ASSAY ON THE EDISON?
ERIKA CHEUNG: WHEN WE STARTED RUNNING --
ERIKA CHEUNG: -- THE VITAMIN D ASSAY? SO WE -- I HAD STARTED RUNNING THE VITAMIN D PERSONALLY ON PATIENT SAMPLES OR IN DEVELOPMENT.
ERIKA CHEUNG: ON PATIENT SAMPLES. AS EARLY IN NOVEMBER OF 2013. IT MAY HAVE EVEN BEEN THE LATER PART OF OCTOBER AS WELL.
ERIKA CHEUNG: OF 2013, YES.
MR. WADE: AND WERE THERE, WERE THERE OTHER TESTS THAT WERE RUN IN THAT EARLY PERIOD IN OCTOBER OR NOVEMBER OF 2013 ON THE EDISON?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO THE FOUR CORE WERE TSH, THYROID STIMULATING HORMONE, TPSA, TOTAL PROSTATE SPECIFIC ANTIGEN, AND THEN FT4, WHICH IS A FREE THYROXINE 4.
MR. WADE: AND THEN THE THREE OTHER ASSAYS THAT WE TALKED ABOUT, TT3, TT4, AND TST. DO YOU RECALL ABOUT WHEN THOSE STARTED TO BE RUN IN THE CLIA LAB?
ERIKA CHEUNG: SO THOSE STARTED TO BE RUN IN THE CLIA LAB, WE STARTED TO SEE MORE ONBOARDING FROM JANUARY ROUGHLY TO FEBRUARY, AND DEFINITELY WITHIN MARCH.
ERIKA CHEUNG: YEAH. IT DEPENDS. IT DEPENDED ON A COUPLE OF FACTORS WHETHER WE WERE ABLE TO HAVE THEM WHAT WE CALL "GO LIVE." WE NEEDED TO MAKE SURE WE HAD THE RANGES, THE CALIBRATION SET UP, THE QC RANGES, AND THERE'S A LOT OF INFRASTRUCTURE YOU HAD TO SET UP. SO IT'S NOT -- IT WOULDN'T -- I WOULDN'T BE ABLE TO TELL YOU THE EXACT DATE AT THIS TIME.
MR. WADE: AND DO YOU RECALL THE TOTAL NUMBER OF EDISON TESTS THAT WERE RUN IN THE CLIA LAB IN, SAY, NOVEMBER OF 2013?
ERIKA CHEUNG: THE TOTAL NUMBER OF EDISON TESTS THAT WERE RUN?
MR. WADE: AND BY THAT LET ME BE MORE SPECIFIC. DO YOU REMEMBER ABOUT HOW MANY PATIENT RESULTS WERE, WERE ANALYZED AND COMMUNICATED IN NOVEMBER OF 2013?
ERIKA CHEUNG: FOR JUST EDISON?
ERIKA CHEUNG: THE TOTAL NUMBER OF PATIENTS WE PROCESSED THAT MONTH?
ERIKA CHEUNG: I WOULDN'T KNOW.
ERIKA CHEUNG: I WOULDN'T KNOW.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: I WOULDN'T KNOW. I WOULDN'T KNOW THAT EXACT NUMBER.
ERIKA CHEUNG: NO.
MR. WADE: I UNDERSTAND. IT'S A SPECIFIC QUESTION FROM A LONG TIME AGO. I'D LIKE TO ASK YOU A COUPLE OF QUESTIONS ABOUT THE HARDWARE QC FOR THE 3.5 DEVICES AFTER THEY WERE IN THE CLINICAL LAB.
ERIKA CHEUNG: UH-HUH.
ERIKA CHEUNG: IN THE QC OF THE ACTUAL EDISON DEVICES?
ERIKA CHEUNG: SO THAT WAS SAMARTHA ANEKAL'S TEAM, SO IT WOULD BE PEOPLE LIKE DAVID PHILIPPEDES, JARED O'LEARY, ALPHONSO NGUYEN, AND THERE ARE A COUPLE OF OTHER ENGINEERS ON THAT TEAM.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: CAN YOU SAY THAT NUMBER AGAIN?
ERIKA CHEUNG: I DON'T BELIEVE I HAVE THAT DOCUMENT. OH, OH, OH. SORRY. IT WAS IN THE BACK.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: DOCUMENT 10480 IS AN EMAIL THAT IS SENT TO THE ELISA TEAM ABOUT THE DAILY QC PROCEDURE THAT SAMARTHA ANEKAL'S TEAM IS PERFORMING ON THE EDISON DEVICES.
ERIKA CHEUNG: YES.
MR. WADE: AND YOU TALKED WITH MR. BOSTIC YESTERDAY ABOUT THE WAY IN WHICH EMAILS WERE COMMUNICATED AND THE IMPORTANCE OF EMAILS AND MAKING SURE THAT THEY WERE ACCURATE. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND YOU RECALLED SOME TESTIMONY ABOUT HOW THESE WERE MAINTAINED, YOU KNOW, IN THE REGULAR COURSE OF BUSINESS?
ERIKA CHEUNG: YES.
MR. WADE: AND THIS PARTICULAR DOCUMENT IS COMMUNICATING SORT OF A POLICY AND PRACTICE THAT WAS TO BE FOLLOWED WITHIN THE LAB?
ERIKA CHEUNG: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10480 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
JUDGE DAVILA: THAT WAS MINE.
BY MR. WADE:
MR. WADE: IF I COULD JUST CALL YOUR ATTENTION TO THE TOP OF THE EMAIL. THIS WAS AN EMAIL THAT WAS SENT NOVEMBER 27TH, 2013?
ERIKA CHEUNG: YES.
MR. WADE: AND YOU MENTION THE ELISA TEAM. I THINK WE TALKED ABOUT THE ELISA TEAM. DO YOU THINK THIS GROUP OF PEOPLE AT THE TOP, THOSE ARE THE ELISA TEAM MEMBERS?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND CAN YOU EXPLAIN TO US -- I'LL CALL YOUR ATTENTION TO THE BODY OF THE EMAIL. NOW, THE SUBJECT LINE WAS 3.5 READER QUALITY CONTROL TEST; RIGHT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO JARED O'LEARY IS AN ENGINEER ON SAMARTHA ANEKAL'S TEAM, AND I DON'T REMEMBER THE NAME OF THE TEAM, BUT IT'S THE DEVICE ENGINEERING TEAM.
ERIKA CHEUNG: I'M SORRY?
ERIKA CHEUNG: I DON'T KNOW GARY FRENZEL.
ERIKA CHEUNG: THIS EMAIL IS A QC PROCEDURE IN ORDER TO DETERMINE HOW WELL THE EDISON DEVICE AND THE HARDWARE OF THE EDISON DEVICE IS PERFORMING, AND HIS TEAM ESSENTIALLY AGGREGATED ALL OF THE INFORMATION AND PUT IT INTO A SPREADSHEET OR A DOCUMENT TO LET US KNOW.
MR. WADE: OKAY. WE TALKED YESTERDAY ABOUT -- OR ON WEDNESDAY ABOUT QUALITY CONTROL THAT YOU WERE RESPONSIBLE FOR. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND IT ASKS -- DO YOU SEE IN THE SECOND PARAGRAPH THERE WHERE IT POINTS TO A DRIVE, S DRIVE?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO THE S DRIVE IS A DATA DRIVE THAT WE HAD THAT WAS SHARED AMONGST DIFFERENT DEPARTMENTS. SO EACH DRIVE HAD DIFFERENT -- LIKE THE J DRIVE, FOR EXAMPLE, WAS FOR RESEARCH AND DEVELOPMENT; CLIA HAD ITS OWN RESTRICTED DRIVE; AND SO THE S DRIVE WAS ANOTHER ONE OF THESE SORT OF DATA DRIVES THAT WE HAD AT THERANOS IN ORDER TO SHARE INFORMATION.
MR. WADE: AND WAS THERE A REQUEST THAT THE DATA THAT WAS DERIVED AS A PART OF THIS PROCESS WAS STORED THERE SO EVERYONE COULD HAVE ACCESS TO IT?
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND LET ME FOCUS ON THE TOP PARAGRAPH IF I COULD. HERE THERE'S A MENTION TO THE SIV TEAM. WHAT IS THE SIV TEAM?
ERIKA CHEUNG: I DON'T REMEMBER WHAT THE ACRONYM STANDS FOR.
ERIKA CHEUNG: I BELIEVE SO, BUT I'M NOT CERTAIN.
MR. WADE: OKAY. AND IT TALKS HERE ABOUT HOW THEY'RE GOING TO DO THIS, THEIR ONLY DAILY QC PROCEDURE, ON THE DEVICES. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND I THINK WE SAW A SPREADSHEET YESTERDAY WHERE YOU WERE TRACKING SOME ISSUES WITH RESPECT TO SOFTWARE AND THE LIKE. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: THAT WAS A SEPARATE PROCESS.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND IF I COULD MOVE YOUR ATTENTION DOWN TO THE PORTION OF THE DOCUMENT STARTING WITH "ONCE," AND THEN GOING THROUGH THE NUMBERED PARAGRAPHS THERE. NOW, HERE THEY WERE TALKING ABOUT IF THE DEVICE'S PERFORMANCE WAS DETERIORATING OVER TIME, THEY WANTED YOU TO MAKE NOTE OF THAT; RIGHT?
ERIKA CHEUNG: CAN I READ IT REALLY QUICKLY?
ERIKA CHEUNG: NO.
COURT CLERK: IS YOURS ON, COUNSEL?
(PAUSE IN PROCEEDINGS.)
MR. WADE: IF WE MIGHT LOOK TO MAKE SURE THE JURORS ARE ABLE TO SEE THE DOCUMENT? I CAN'T, BUT I CAN WORK WITHOUT IT.
JUDGE DAVILA: IS THIS UP ON THE MONITOR? I'M SEEING AFFIRMATIVE NODS.
ERIKA CHEUNG: OKAY.
(PAUSE IN PROCEEDINGS.)
BY MR. WADE:
ERIKA CHEUNG: YES.
MR. WADE: AND DO YOU RECALL THIS WAS ASKING IF YOU SAW A DETERIORATION IN THE PERFORMANCE OF THE DEVICE OR IMPRECISION OR INACCURACY TO MAKE NOTE OF THAT AND PUT IT INTO THAT DRIVE?
ERIKA CHEUNG: SO THIS IS ACTUALLY SAYING THAT THEY TRACK THIS INFORMATION. SO THE SIV TEAM ESSENTIALLY TRACKS THE PERFORMANCE OF THE DEVICES, AND THEY ARE CREATING A GRAPH TO ALLOW US TO KNOW IF WE ARE HAVING AN ISSUE ON THE DEVICE SIDE OR ON THE CHEMISTRY SIDE. SO THEY WERE COLLECTING A WHOLE BUNCH OF QC DATA TO ALLOW US TO KNOW WHETHER THERE WAS DETERIORATION OVER TIME IN THE DEVICE PERFORMANCE. SO WE DIDN'T ACTUALLY AGGREGATE THAT INFORMATION. THE SIV TEAM IS AGGREGATING THAT AND TELLING US THAT WE CAN LOOK OVER IT IN THIS DOCUMENT THAT THEY PUT ON THE S DRIVE.
MR. WADE: AND THAT TEAM WAS DOING A COMPLETELY SEPARATE PROCESS INDEPENDENT OF YOU, BUT SHARING THOSE RESULTS WITH YOU SO THAT YOU COULD ACCESS THEM IF YOU HAD QUESTIONS?
ERIKA CHEUNG: EXACTLY.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. COULD I CALL YOUR ATTENTION TO EXHIBIT 9909 WHICH I THINK IS IN YOUR BINDER AS WELL.
ERIKA CHEUNG: YEAH, I HAVE IT, BUT THE BINDER -- I DIDN'T REALIZE IT WAS UNCLASPED, SO GIVE ME ONE SECOND. I'M GOING TO JUST SET THIS SEPARATELY HERE. OKAY.
ERIKA CHEUNG: ALL RIGHT. EXCELLENT. YES, I SEE THE DOCUMENT.
ERIKA CHEUNG: THIS IS A STANDARD QUALITY OPERATING PROCEDURE FOR THE CLIA LABORATORY.
ERIKA CHEUNG: IN THIS CASE WHAT THEY'RE DOING IS CORRECTIVE AND PREVENTATIVE ACTION. SO IF YOU'RE SEEING AN ISSUE, TO BE ABLE TO ESSENTIALLY RECORRECT FOR THE ISSUES OR THE ERRORS THAT YOU SEE.
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I HAD NEVER SEEN THIS DOCUMENT.
ERIKA CHEUNG: NO.
MR. WADE: OKAY. DO YOU RECOGNIZE THAT THE DOCUMENT WAS ONE THAT WAS KEPT AS A MATTER OF RECORD IN THE CLIA LAB BASED ON THE FORMAT AND THE LOGGING OF THE DOCUMENT?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, OBJECTION UNDER 602 AND 901.
JUDGE DAVILA: OVERRULED. IT'S ADMITTED. IT'S ADMITTED.
(DEFENDANT'S EXHIBIT 9909 WAS RECEIVED IN EVIDENCE.)
JUDGE DAVILA: YES.
BY MR. WADE:
MR. WADE: IS THAT DOCUMENT IN FRONT OF YOU, MS. CHEUNG? I'M NOT ALWAYS SEEING WHAT YOU'RE SEEING.
ERIKA CHEUNG: YEAH, IT IS.
MR. WADE: AND JUST FOCUSSING YOU ON THE TITLE PAGE OF THIS DOCUMENT, THIS WAS, LIKE SIMILAR POLICIES THAT YOU WERE LOOKING AT WEDNESDAY, ONE THAT WAS PREPARED AND RATIFIED BY THE LAB DIRECTOR AT THERANOS?
ERIKA CHEUNG: YES.
MR. WADE: AND IF WE CAN GO TO PAGE 3 OF 8 OF THE DOCUMENT, WHICH IS THE BATES RANGE ENDING 99. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND DO YOU SEE THAT THIS IS THE PURPOSE SECTION OF THE DOCUMENT THAT SETS FORTH A CORRECTIVE ACTION PROGRAM? IS THIS WHAT YOU WERE REFERRING TO IN YOUR TESTIMONY A MINUTE AGO?
ERIKA CHEUNG: OH, JUST RIGHT PRIOR?
ERIKA CHEUNG: YES.
MR. WADE: AND IF WE CAN GO TO PAGE 4 AND LOOK AT PARAGRAPH 4, DO YOU SEE THAT SETS FORTH THE RESPONSIBILITIES OF DIFFERENT PEOPLE WITH RESPECT TO THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: IT IS THE RESPONSIBILITY OF THE QUALITY MANAGER, LAB DIRECTOR IN ORDER TO UNCOVER NONCONFORMANCES DURING INTERNAL AUDITS.
MR. WADE: IF WE CAN LOOK AT PAGE 5. DO YOU SEE ON THAT PAGE IT SETS FORTH KIND OF A DETAILED PRACTICE AS TO HOW YOU'RE SUPPOSED TO GO ABOUT IMPLEMENTING THIS?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND THEN IF WE CAN TURN TO PAGE 7, THAT TALKS ABOUT THE RECORDS THAT ARE SUPPOSED TO BE MAINTAINED BY THE LAB DIRECTOR AND QUALITY MANAGER DOCUMENTING THOSE INCIDENTS?
ERIKA CHEUNG: YES.
MR. WADE: I DON'T HAVE ANYTHING FURTHER ON THIS DOCUMENT. IF WE CAN BRING UP -- WELL, MAYBE WE DON'T NEED THE DOCUMENT RIGHT NOW. DO YOU RECALL SOME TESTIMONY, IT WAS EITHER TUESDAY OR WEDNESDAY, ABOUT A VITAMIN D QC FAILURE THAT HAPPENED ON THE THANKSGIVING WEEKEND? DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND I WOULD LIKE TO TALK TO YOU A LITTLE BIT ABOUT THAT. FIRST, I'D LIKE TO SET FORTH THE POLICY ON THE NORMANDY 911. IF WE CAN LOOK AT -- DO YOU HAVE 10479 IN YOUR BOOK?
ERIKA CHEUNG: YES, I HAVE IT.
ERIKA CHEUNG: THIS IS AN EMAIL SENT BY SHARADA SIVARAMAN ESSENTIALLY TELLING US THAT IF WE HAVE ANY ISSUES IN THE NORMANDY LAB WITH ANY OF THE WALGREENS SAMPLES, THAT WE SHOULD CONTACT NORMANDY 911.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: IT WAS THE COMMUNICATION, YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: IN A POLICY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. BOSTIC: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 10479 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: NOW THAT WE CAN SEE THE DOCUMENT, DR. SIVARAMAN IS SENDING THIS. I THINK THERE MAY BE A COUPLE OF NEW NAMES ON THIS DOCUMENT. DARREN CRANDALL. WHO IS DARREN CRANDALL?
ERIKA CHEUNG: DARREN CRANDALL WAS ONE OF THE LAB ASSOCIATES AS WELL, BUT HE HAD ABOUT ONE TO TWO YEARS EXPERIENCE AND HE WAS PART OF THE ELISA TEAM.
ERIKA CHEUNG: AURELIE SOUPPE WAS ALSO A LAB ASSOCIATE WITHIN THE ELISA TEAM AND SHE ALSO ENDED UP BEING INTEGRATED INTO THE CLINICAL LAB. MYSELF. ROMINA RIENER, WHO ALSO WAS A LAB ASSOCIATE, AND SHE ALSO GOT INTEGRATED INTO THE CLINICAL LAB. ANDREW KIM, HE HAD WORKED AT THERANOS MAYBE ONE TO THREE YEARS, AND HE WAS ALSO A LAB ASSOCIATE AND STAYED AND WORKED IN ELISA IN THE RESEARCH AND DEVELOPMENT LAB. JAMIE LIU, WHO WAS ALSO A LAB ASSOCIATE AND GOT HIRED AROUND THE TIME THAT I DID, SHE WAS ON THE ELISA TEAM AND THEN GOT INTEGRATED INTO THE CLINICAL LAB AS WELL. AND THEN UYEN DO, WHO WAS A LAB ASSOCIATE AS WELL, SHE HAD MAYBE ONE TO TWO YEARS EXPERIENCE AT THERANOS AND IN THE ELISA RESEARCH AND DEVELOPMENT LAB.
MR. WADE: OKAY. AND IF WE LOOK JUST AT THE BODY OF THE EMAIL, THIS SET FORTH THAT PRACTICE OF SENDING THE EMAIL IF SOMETHING COMES UP?
ERIKA CHEUNG: YES.
MR. WADE: AND WAS PART OF THAT A CONCERN THAT ON A HOLIDAY WEEKEND OR SOMETHING OF THAT NATURE, IT MAY BE HARD TO REACH PEOPLE?
ERIKA CHEUNG: YES.
MR. WADE: AND SO YOU WANTED TO MAKE SURE THAT YOU COULD SEND IT OUT TO A BROAD GROUP SO ANYONE COULD HELP WITH THE PROBLEM?
ERIKA CHEUNG: YES.
MR. WADE: IF WE CAN BRING UP 1287, WHICH I BELIEVE IS IN EVIDENCE. IF WE CAN FOCUS IN ON THE SECOND PAGE, AND THE EMAIL IN THE MIDDLE. AND CAN YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND I APOLOGIZE TO KEEP ASKING, BUT MY SCREEN IS FLICKERING A LITTLE BIT. I JUST WANT TO MAKE SURE THAT YOU CAN SEE IT. I HAVE A COPY.
ERIKA CHEUNG: OF COURSE.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
JUDGE DAVILA: I'M SORRY, WHAT NUMBER?
ERIKA CHEUNG: THIS IS IN THE BINDER.
COURT CLERK: I WANT TO MAKE SURE THAT EVERYONE'S MONITORS ARE OFF?
JUROR: THEY'RE OFF.
ERIKA CHEUNG: 1288.
MR. WADE: COULD WE PAUSE FOR MAYBE 30 SECONDS, YOUR HONOR, AND JUST TEND TO THE SCREENS? I THINK WE'RE HAVING SCREEN DIFFICULTIES. I DON'T KNOW IF THE COURT IS.
JUDGE DAVILA: SURE. TAKE CARE OF YOUR SCREENS ON THE TABLES.
COURT CLERK: IT'S OKAY BECAUSE THE MONITORS SHOULD BE OFF NOW. JUST THE WITNESS WILL SHOW.
ERIKA CHEUNG: IT'S A LOOSE DOCUMENT, 12 --
ERIKA CHEUNG: OH, YES.
MR. WADE: AND IS THIS A DIFFERENT VERSION OF THAT SAME CHAIN. IF YOU SCROLL DOWN, WE CAN SHOW YOU THE SECOND PAGE?
ERIKA CHEUNG: NO, IT'S THE SAME VERSION.
ERIKA CHEUNG: YES.
JUDGE DAVILA: 88?
MR. BOSTIC: YOUR HONOR, THIS VERSION CONTAINS SOME NEW CONTENT. JUST FOR CLARIFICATION, IS DEFENSE COUNSEL VIEWING THAT CONTENT AS A BUSINESS RECORD?
MR. WADE: WE ADMITTED ESSENTIALLY THE SAME DOCUMENT THAT THE WITNESS WAS NOT ON YESTERDAY, I JUST WANT TO BE COMPLETE ABOUT THIS, AN EMAIL CHAIN UP ON TOP AND THERE WAS A SLIGHTLY DIFFERENT --
JUDGE DAVILA: WAS THAT 87?
JUDGE DAVILA: RIGHT.
MR. BOSTIC: YOUR HONOR, IF THE NEW CONTENT THAT IS COMING IN WITH THIS EXHIBIT IS BEING MOVED IN UNDER THE BUSINESS RECORDS EXCEPTION, THEN THE GOVERNMENT HAS NO OBJECTION.
JUDGE DAVILA: I THINK THAT'S WHAT YOU'RE --
JUDGE DAVILA: ALL RIGHT. THANK YOU. IT'S ADMITTED. IT MAY NOW BE PUBLISHED. THANK YOU.
(GOVERNMENT'S EXHIBIT 1288 WAS RECEIVED IN EVIDENCE.)
COURT CLERK: COUNSEL, YOU CAN TURN YOUR MONITORS BACK ON.
BY MR. WADE:
MR. WADE: OKAY. DO YOU SEE UP AT THE TOP THERE THERE'S AN EMAIL FROM DANIEL YOUNG -- THERE'S AN EMAIL FROM DANIEL YOUNG ON NOVEMBER 30TH, 2013, AT 11:17 A.M., THE BOTTOM EMAIL ON THE SCREEN. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND HE WAS EXPLAINING THAT ONE OF THE QC RUNS PASSED (AFTER THE SOP WAS FOLLOWED APPROPRIATELY)?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: IN TERMS OF THE OUTLIER DELETION?
ERIKA CHEUNG: NO.
ERIKA CHEUNG: I DISAGREED WITH MR. YOUNG.
ERIKA CHEUNG: THE RESEARCH AND DEVELOPMENT ASSOCIATE FOR UYEN DO?
MR. WADE: JUST WITH RESPECT TO -- YEAH, WITH RESPECT TO WHETHER IT WAS MR. DO OR WHOEVER IT WAS THAT FAILED TO FOLLOW THE QC POLICY, DO YOU KNOW WHETHER THERE WAS ANY RETRAINING THAT HAPPENED AS A RESULT OF THAT?
ERIKA CHEUNG: I WOULDN'T KNOW FOR UYEN DO. BUT IN OUR CASE NO. WE -- WELL, NO.
MR. WADE: OKAY. I DON'T HAVE ANYTHING MORE ON THIS DOCUMENT. IF WE CAN PUT UP EXHIBIT 1512, WHICH IS IN EVIDENCE.
COURT CLERK: 1512?
MR. WADE: IF I COULD DRAW YOU TO THE TOP OF THE SECOND PAGE. THIS WAS THE FEBRUARY 2014 HEPATITIS C INCIDENT?
ERIKA CHEUNG: YES.
MR. WADE: AND THIS WAS THE FIRST TIME WHERE THERANOS WAS ACTUALLY GOING TO RUN THIS PARTICULAR ASSAY IN THE LAB; RIGHT?
ERIKA CHEUNG: FOR A PATIENT, YES.
MR. WADE: AND IF I CAN DIRECT YOU TO THIS EMAIL, DO YOU SEE FROM MR. ROSENDORFF, AND HE SAYS, "SOP AND VALIDATION HAS BEEN WRITTEN, AND APPROVED." AND THEN THERE'S DISCUSSION ABOUT GETTING SOME CARTRIDGES READY. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND THEN IF WE CAN GO TO THE BOTTOM OF THE FIRST PAGE, THIS IS AT 6:29 P.M. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: IT SAYS THAT THERE WAS A CONCERN EXPRESSED TO ME. SO I HAD TALKED TO SURAJ ABOUT MY CONCERNS ABOUT THE STABILITY OF THE REAGENTS WITH THE CAPSYS, C-A-P-S-Y-S, CARTRIDGES.
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: YES.
MR. WADE: AND THERE WAS DISCUSSION ABOUT, WELL, LET'S RUN THE CONTROLS AND SEE WHAT HAPPENS; RIGHT?
ERIKA CHEUNG: YES.
MR. WADE: AND YOU EXPRESSED CONCERN ABOUT RUNNING THE TEST IN THE LAB. YOU WERE HAPPY TO RUN THE CONTROLS BECAUSE THAT'S NOT PATIENT BLOOD; RIGHT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: THEY DIDN'T RUN IT ON THE EDISON. IT WAS RUN ON THE ORAQUICK.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: WHILE I WAS AT THE COMPANY.
MR. WADE: I DON'T HAVE ANY MORE QUESTIONS ON THAT DOCUMENT. THERE WERE, THERE WERE A COUPLE OF QUESTIONS THAT YOU WERE ASKED THE OTHER DAY ABOUT A LETTER THAT YOU RECEIVED FROM A LAWYER FOR THERANOS. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: OKAY.
MR. WADE: OKAY. YOU TALKED ABOUT SOME DISCUSSIONS THAT YOU HAD WITH A "WALL STREET JOURNAL" REPORTER. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I BELIEVE IT WAS LATE MAY OR EARLY JUNE.
MR. WADE: OKAY. LATE MAY OR EARLY JUNE THAT YOU HAD THOSE CONVERSATIONS OR STARTED HAVING THOSE CONVERSATIONS?
ERIKA CHEUNG: I BELIEVE IT WAS -- GIVE ME ONE SECOND. I BELIEVE IT WAS LATE MAY.
MR. WADE: OKAY. AND DO YOU RECALL IN THE SUMMER OF 2015 THAT THE HR DIRECTOR FROM THERANOS ACTUALLY TRIED TO CALL YOU AND LEFT A MESSAGE. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: YES.
MR. WADE: YOU TESTIMONY THAT YOU HAD YESTERDAY ABOUT SOME OF THE WORK ON THE ASSAYS IN THE R&D SIDE OF THE HOUSE, DO YOU RECALL SOME OF THAT TESTIMONY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: IN THE RESEARCH AND DEVELOPMENT LAB?
ERIKA CHEUNG: YES.
MR. WADE: AND YOU THOUGHT ABOUT 12 ASSAYS TOTAL HAD BEEN COMPLETE. AND I KNOW YOU'RE NOT SURE ON THE NUMBER, BUT DO YOU RECALL WHICH ASSAYS HAD BEEN COMPLETED ON THE RESEARCH AND DEVELOPMENT SIDE?
ERIKA CHEUNG: WOULD HAVE BEEN COMPLETED?
ERIKA CHEUNG: DO YOU WANT THE NUMBER OR NAMES?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO VITAMIN D, TPSA, FT4, TSH, TT3, TT4, TOTAL TESTOSTERONE, TROPONIN, HEPATITIS C, HCG, FSH. AND I BELIEVE THAT'S IT, BUT I COULD BE MISSING ONE OR TWO.
MR. WADE: OKAY. THANK YOU. I WANT TO SHIFT TO SOME OF YOUR TESTIMONY ABOUT OUTLIERS. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND I WAS JUST WONDERING, DURING YOUR TIME AT THERANOS, YOU WERE AWARE OF ANY INDUSTRY STANDARDS WITH RESPECT TO OUTLIER REMOVAL?
ERIKA CHEUNG: INDUSTRY STANDARDS?
ERIKA CHEUNG: IN TERMS OF OUTLIER REMOVAL?
ERIKA CHEUNG: NO.
ERIKA CHEUNG: EXCEPT FOR IN THERANOS WE USED SOMETHING CALLED WESTGARD RULES.
ERIKA CHEUNG: BUT THAT WAS MORE ON THE QUALITY CONTROL SIDE OF WHAT WOULD BE CONSIDERED AN OUTLIER FOR QC'S.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. BUT WITH RESPECT TO OUTLIER REMOVAL SPECIFICALLY, YOU DON'T RECALL ANY -- LEARNING OF ANY INDUSTRY STANDARDS?
ERIKA CHEUNG: NO.
MR. WADE: OKAY. AND WITH RESPECT TO THOSE ISSUES, BASED ON OUR -- BASED ON YOUR TESTIMONY ON WEDNESDAY, IS IT FAIR TO SAY THAT THE IMPLEMENTATION OF POLICIES RELATING TO THESE ISSUES WOULD HAVE BEEN THE RESPONSIBILITY OF DR. ROSENDORFF?
ERIKA CHEUNG: THE IMPLEMENTATION OF AN OUTLIER POLICY?
ERIKA CHEUNG: I JUST ASSUMED IT WAS OF THE CLINICAL LAB, THAT IT WAS THE RESPONSIBILITY OF THERANOS'S CLINICAL LAB TO IMPLEMENT THOSE POLICIES.
MR. WADE: RIGHT. DO YOU RECALL WE LOOKED AT THE PERSON WHO WAS RESPONSIBLE FOR THE IMPLEMENTATION OF THAT, THAT WAS THE LAB DIRECTOR?
ERIKA CHEUNG: AND THE QUALITY CONTROL MANAGER, YES.
MR. WADE: YEAH. IF I CAN BRING UP 1431, WHICH I THINK IS IN EVIDENCE, AND JUST DIRECT YOU TO THE BOTTOM OF THE THIRD PAGE.
ERIKA CHEUNG: CAN YOU GIVE ME THAT NUMBER AGAIN? I'M SORRY.
ERIKA CHEUNG: OKAY.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: AT THAT TIME, YES.
MR. WADE: OKAY. AND DO YOU SEE IN THAT SECOND PARAGRAPH WHERE IT SAYS, "SINCE WE ARE ALLOWED TO REMOVE 2 DATA POINTS FROM 6 (1 CARTRIDGE OUT OF 3)." DO YOU SEE THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND IF I COULD DIRECT YOU TO THE TOP OF THE THIRD PAGE. AND DO YOU SEE IN THE SECOND PARAGRAPH MR. ROSENDORFF IS TALKING ABOUT THE CREATION OF A PROTOCOL?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I WOULDN'T KNOW THAT.
ERIKA CHEUNG: NO.
MR. WADE: OKAY. AND DO YOU RECALL YOU WERE ASKED A FEW QUESTIONS ABOUT AN EMAIL THAT YOU WEREN'T ON BETWEEN MR. SHULTZ AND MS. HOLMES?
ERIKA CHEUNG: YES.
MR. WADE: AND THAT WAS EXHIBIT 1660. IF WE CAN PULL THAT UP. AND I JUST WANT TO ASK A COUPLE OF POINTS OF CLARIFICATION ON THAT.
ERIKA CHEUNG: OKAY.
COURT CLERK: THIS IS IN EVIDENCE, COUNSEL?
JUDGE DAVILA: I THINK THIS WAS ADMITTED FOR A LIMITED PURPOSE.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YEP.
ERIKA CHEUNG: YES.
MR. WADE: AND THIS REFERENCES THE FACT THAT MR. SHULTZ AND MS. HOLMES HAD HAD A PRIOR DISCUSSION ABOUT THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND IF WE CAN GO TO THE NEXT EMAIL UP THE CHAIN, WHICH I THINK IS MAYBE WITHIN THE HOUR OR ABOUT AN HOUR LATER. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: BUT SHE SPECIFICALLY ASKED TYLER TO WRITE EVERYTHING DOWN THAT WAS OF CONCERN SO IT COULD BE ADDRESSED; RIGHT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND IF WE CAN JUST GO TO THE TOP OF THAT LENGTHY EMAIL AND JUST LOOK AT THE FIRST PARAGRAPH, THE FIRST EMAIL ON THIS PAGE OF 1660. AND DO YOU SEE THERE THAT IT SAYS, "IN MY MEETINGS WITH DANIEL"? DO YOU SEE THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: TYLER HAD A MEETING WITH DANIEL YOUNG TO DISCUSS SOME OF THESE ISSUES.
ERIKA CHEUNG: I DON'T KNOW THAT.
ERIKA CHEUNG: YES.
MR. WADE: I DON'T HAVE ANY MORE QUESTIONS ABOUT THIS. I HAVE A COUPLE OF POINTS OF CLARIFICATION ON THE QC, THE DAILY QC WITHIN THE CLIA LAB, THE PART THAT YOU WERE RESPONSIBLE FOR, NOT THE HARDWARE PART.
ERIKA CHEUNG: OKAY.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: AGAIN, I THOUGHT IT WAS THE CLINICAL LAB, THE RESPONSIBILITIES OF THE CLINICAL LAB, SO LANGLY GEE, ADAM ROSENDORFF, MARK PANDORI, AND THE CLINICAL LAB SCIENTISTS.
ERIKA CHEUNG: YES.
MR. WADE: AND ACTUALLY, DO YOU RECALL THAT THERE WAS ACTUALLY A SPECIAL KIND OF COMMITTEE THAT WAS FORMED TO TRY TO WORK ON THE ISSUES RELATING TO THAT?
ERIKA CHEUNG: IN THE CLINICAL LAB.
ERIKA CHEUNG: I BELIEVE SO, BUT I CAN'T BE CERTAIN.
MR. WADE: A SPECIAL GROUP OF PEOPLE THAT WAS FORMED TO TRY TO MAKE IMPROVEMENTS TO THE PROCESSES AND PROCEDURES AND ADDRESS ISSUES SO THAT THE COMPANY WAS IN A GOOD POSITION WHEN IT WENT FROM JUST A FEW TESTS UP TO MANY MORE?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: NISHIT DOSHI, KATHRYN ROMMEL, CURTIS -- I FORGOT HIS LAST NAME. DANIEL YOUNG. AND THOSE ARE THE ONLY PEOPLE THAT I CAN REMEMBER AT THIS TIME.
ERIKA CHEUNG: I DON'T REMEMBER.
ERIKA CHEUNG: I DON'T REMEMBER.
ERIKA CHEUNG: I DON'T REMEMBER.
ERIKA CHEUNG: YEAH, I JUST DON'T REMEMBER.
MR. WADE: OKAY. THAT'S FAIR. AND I JUST WANT TO CONFIRM THAT THE -- WHEN THERE'S A QC FAILURE ON A MACHINE, THERE ARE NOT PATIENT SAMPLES THAT WENT OUT ON THAT MACHINE WHEN YOU WERE RUNNING IT; RIGHT?
ERIKA CHEUNG: WHEN THERE'S A QC FAILURE?
ERIKA CHEUNG: IF THERE'S NO RESOLUTION FOR THE QC FAILURE, THEN, NO, IT GETS RECALIBRATED.
MR. WADE: AND IT STOPS AND, UNTIL THE MACHINE IS RIGHT, THERE ARE NO PATIENT SAMPLES GOING OUT; RIGHT?
ERIKA CHEUNG: CORRECT.
MR. WADE: OKAY. AND THERE WAS SOME TESTIMONY ON TUESDAY OR WEDNESDAY THAT YOU GAVE ABOUT HOW THREE OF THE EDISON DEVICES WERE RUNNING TWO SAMPLES EACH FOR A PATIENT. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND THERE WAS ACTUALLY AN EFFORT MADE LATER IN YOUR TIME AT THE COMPANY TO TRY AND STREAMLINE THAT; RIGHT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO ESSENTIALLY INSTEAD OF USING THREE CARTRIDGES WITH THREE SEPARATE MACHINES, BECAUSE THERE ARE TWO REACTION TIPS PER CARTRIDGE, THEY TRIED TO COMBINE THESE REACTION TIPS IN ONE CARTRIDGE FOR ONE MACHINE. SO YOU WOULD RUN ONE PATIENT WITH ONE TEST ON ONE CARTRIDGE, BUT IT WOULD BE SIX TIPS OF THE SAME, SO LIKE SIX TIPS OF VITAMIN D ON TO ONE EDISON DEVICE.
ERIKA CHEUNG: EXACTLY.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. BUT THE EDISON MACHINE WAS STILL -- LET ME STRIKE THAT. DO YOU KNOW WHAT A LOW THROUGHPUT DEVICE IS?
ERIKA CHEUNG: A LOW THROUGHPUT DEVICE?
ERIKA CHEUNG: I DON'T REMEMBER AT THIS TIME.
ERIKA CHEUNG: YES.
MR. WADE: BECAUSE I THINK YOU TALKED ABOUT THE ULTIMATE GOAL WAS TO DEPLOY THE DEVICE IN WALGREENS LOCATIONS AND OTHER PLACES AFTER FDA APPROVAL; RIGHT?
ERIKA CHEUNG: CORRECT.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: ONE PATIENT, ONE TEST AT A TIME, YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: 1800 TESTS AN HOUR?
MR. WADE: YEAH. IS IT CORRECT THAT THE 1800 COMES FROM THE NUMBER OF TESTS THAT IT CAN RUN PER HOUR?
ERIKA CHEUNG: I DON'T KNOW.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND YOU TALKED ABOUT HOW THERANOS DEVELOPED A METHOD FOR RUNNING SMALL SAMPLES ON THOSE MACHINES?
ERIKA CHEUNG: YES.
MR. WADE: DO YOU RECALL THAT? AND BEFORE IT HAD DEVELOPED THAT METHOD, THAT WASN'T POSSIBLE ON THAT MACHINE; RIGHT?
ERIKA CHEUNG: SAY THAT ONE MORE TIME. BEFORE WE DEVELOPED THAT METHOD, IT WASN'T POSSIBLE ON THAT MACHINE?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: HIGH VOLUME SMALL SAMPLES?
ERIKA CHEUNG: NO.
ERIKA CHEUNG: IN THE DILUTION. SO IN THE TECAN, THE DILUTION, AND THE T-CUP.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND, IN FACT, DID THEY HAVE A WHOLE MANUFACTURING SORT OF INFRASTRUCTURE WITH DIFFERENT MACHINES AND THE LIKE; RIGHT?
ERIKA CHEUNG: IN ORDER TO PRODUCE THE T-CUPS AND THE CARTRIDGES, THEY HAD, LIKE, A 3D PRINTING, YEAH, MANUFACTURING FLOOR ON THE FIRST FLOOR.
MR. WADE: RIGHT. WHERE THEY DID THE TOOTLING AND THE ROBOTICS RELATING TO THE PRODUCTION OF THOSE ITEMS. DO YOU RECALL THAT?
ERIKA CHEUNG: YES. YES.
MR. WADE: OKAY. AND THE -- WERE YOU AWARE THAT THERANOS RECEIVED A PATENT FOR THE IMPROVEMENTS THAT IT DEVELOPED FOR THE SYSTEM IT DEVELOPED FOR USE IN THE ADVIA MACHINE?
ERIKA CHEUNG: NO.
MR. WADE: LET ME CALL YOUR ATTENTION TO 9645. YOUR HONOR, I BELIEVE THIS IS A SELF-AUTHENTICATING PUBLIC RECORD. I WOULD MOVE FOR ITS ADMISSION.
MR. BOSTIC: YOUR HONOR, WE STIPULATED TO THE AUTHENTICITY. NO OBJECTION.
JUDGE DAVILA: THANK YOU. IT IS RECEIVED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9645 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND DO YOU SEE ON THE -- IN THE LEFT-HAND COLUMN THERE WHERE IT SAYS THE APPLICANT WAS THERANOS INC.?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO SAM GONG -- I DON'T REMEMBER WHAT HE DID AT THERANOS; DANIEL YOUNG, WHO WAS THE VICE PRESIDENT AT THERANOS; AND THEN WILLIAM WESTRICK. I DON'T --
ERIKA CHEUNG: I DON'T KNOW WHO WILLIAM WESTRICK IS.
ERIKA CHEUNG: SAM GONG AND DANIEL -- SAM GONG WAS.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: NO.
MR. WADE: OKAY. WELL, I WON'T SPEND A LOT OF TIME GOING THROUGH IT THEN. BUT LET ME JUST DRAW YOUR ATTENTION DOWN TO THE BOTTOM OF THE PAGE. DO YOU SEE THAT DRAWING THERE?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: THE T-CUP?
ERIKA CHEUNG: YES.
MR. WADE: AND IF WE GO ON TO THE SECOND PAGE, SOME OF THE ENGINEERING DRAWINGS I THINK RELATING TO THAT ARE IDENTIFIED?
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: YEP.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND THEN VERY BRIEFLY. ON THE FIFTH PAGE, DO YOU SEE IT STARTS TO TALK ABOUT THE DEVICES, METHODS, AND SYSTEMS FOR REDUCING THE SAMPLE VOLUME? DO YOU SEE THAT? IT'S IN THE HEADING AT THE TOP THERE.
ERIKA CHEUNG: YES.
MR. WADE: AND THIS WAS A PATENT THAT RELATED TO THE DEVICES, METHODS, AND SYSTEMS FOR REDUCING SAMPLE VOLUME?
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND I WON'T BORE EVERYONE BY GOING THROUGH THE NEXT 20 PAGES OR SO. BUT IF WE CAN GO TO THE LAST PAGE. DO WE HAVE UP -- AND THERE WE ARE. DO YOU SEE THE CLAIMS FOR THE PATENT THERE?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: THIS WAS AFTER MY TIME AT THE COMPANY. THIS WAS IN 2016, SO, NO, I WASN'T AWARE OF ANY OF THIS.
ERIKA CHEUNG: WHAT WAS THAT NUMBER?
ERIKA CHEUNG: OKAY.
COURT CLERK: I BELIEVE IT'S 3741A.
ERIKA CHEUNG: THAT'S IN THE BINDER?
JUDGE DAVILA: OKAY.
COURT CLERK: PAGES 1 THROUGH 7 ONLY, YOUR HONOR.
ERIKA CHEUNG: YES.
MR. WADE: AND THE FIRST FOUR PAGES OF THIS DOCUMENT ARE LISTS OF TESTS THAT WERE OFFERED AT THERANOS?
ERIKA CHEUNG: YES.
MR. WADE: AND I THINK YOU TALKED ABOUT THE MISSION OF THERANOS, AS PART OF YOUR TESTIMONY, TO OFFER LOW PRICES. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND FIND THOSE PRICES. AND WERE YOU AWARE THAT THEY CHARGED INSURED AND UNINSURED PATIENTS THE SAME PRICE?
ERIKA CHEUNG: UH, NO, I WASN'T AWARE OF THAT.
MR. WADE: OH, YOU WEREN'T. IF WE COULD GO TO -- I'M SORRY. IF WE CAN GO BACK TO THE FIRST PAGE, IT MAY BE THE EASIEST WAY TO LOOK AT IT. I'M NOT GOING TO GO THROUGH AND HAVE US COUNT THESE. BUT IS IT FAIR TO SAY IN THESE FIRST FEW PAGES THERE ARE SEVERAL HUNDRED TESTS?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND THEN IF WE CAN GO TO THE FORM 15291. DO YOU RECALL THAT YOU GAVE SOME TESTIMONY RELATING TO THIS FORM AS WELL?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND WOULD BE FILLED OUT AND WOULD BE IN THE DOCUMENTS OF THE COMPANY AND IT WOULD BE WITH DOCTORS AND --
ERIKA CHEUNG: WITH CLINICIANS, YES.
ERIKA CHEUNG: YES.
MR. WADE: AND IF YOU COULD JUST ZOOM IN ON THE TOP THERE. AND DO YOU SEE THERE'S A BOX THERE WHERE YOU CAN CHECK MICRO SAMPLE, PATIENT'S CHOICE, OR TRADITIONAL PHLEBOTOMY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: I HAVE NO FURTHER QUESTIONS ABOUT THAT DOCUMENT. I THINK WE ACTUALLY ENDED ON WEDNESDAY TALKING A LITTLE BIT ABOUT PROFICIENCY TESTING. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND I THINK YOU SAID THAT YOU WERE NOT FAMILIAR WITH THE PROFICIENCY TESTING POLICY WHEN YOU WERE WITH THE COMPANY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: ASIDE FROM RUNNING THE ACTUAL TEST, YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND I THINK YOU TESTIFIED THAT YOU'RE AWARE THAT PROFICIENCY TESTING IS DESIGNED TO COMPARE SIMILAR DEVICES; IS THAT RIGHT?
ERIKA CHEUNG: THE PURPOSE OF PROFICIENCY TESTING?
MR. WADE: NO. JUST THAT IT'S DESIGNED TO KIND OF COMPARE APPLES TO APPLES, A SIMILAR TYPE OF TEST TO ANOTHER SIMILAR TYPE OF TEST?
ERIKA CHEUNG: IN TERMS OF -- CAN YOU REPEAT YOUR QUESTION?
MR. WADE: SURE. I THINK YOU'VE TESTIFIED THAT PROFICIENCY TESTING RELATES TO PEER DEVICES OR SIMILAR DEVICES; RIGHT?
ERIKA CHEUNG: SO WHEN YOU DO PROFICIENCY TESTING, YOU'LL TEND TO NOTIFY THE TESTING AGENCY OF WHAT TYPE OF DEVICE THAT YOU'RE UTILIZING. SO SAY IF THEY HAVE A TSH SAMPLE, YOU'LL TELL THEM THAT YOU'RE RUNNING IT ON THE IMMULITE IN ORDER TO ALLOW THEM TO KNOW THAT THAT IS THE TESTING DEVICE THAT YOU'RE UTILIZING, YES.
MR. WADE: AND THEN THE PEER GROUP THAT YOU'RE COMPARING THE RESULTS AGAINST ARE OTHER IMMULITE DEVICES OR SIMILAR DEVICES THAT SHOULD PRODUCE THE SAME RESULTS?
ERIKA CHEUNG: I'M NOT TOO SURE, BUT TYPICALLY I WOULD SAY, YES, I THINK SO.
ERIKA CHEUNG: YOU WANT TO COMPARE THE TWO RESULTS, YES.
ERIKA CHEUNG: NO.
ERIKA CHEUNG: I'M TAKING A GUESS HERE. IS IT THE PATHOLOGY ASSOCIATION?
ERIKA CHEUNG: NO.
ERIKA CHEUNG: NO.
MR. WADE: WE -- YOU GAVE SOME TESTIMONY ABOUT THAT SPREADSHEET OF SOME EDISON RESULTS THAT MR. BOSTIC ASKED YOU A NUMBER OF QUESTIONS ABOUT. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND IT HAD THE PERCENTAGES AND THE LIKE. AND ARE YOU AWARE THAT THE TESTING -- THOSE RESULTS, I BELIEVE, WERE SHARED WITH YOU BY LANGLY GEE WHO WAS THE QUALITY CONTROL MANAGER?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND ARE YOU AWARE THAT THE WAY IN WHICH THOSE TESTS WERE IMPLEMENTED CREATED SOME CONFUSION WITHIN THE GROUP ABOUT THE APPLICATION OF THE PROFICIENCY TESTING POLICY?
ERIKA CHEUNG: YES.
MR. WADE: AND WERE YOU AWARE THAT DR. PANDORI AND DR. ROSENDORFF ACTUALLY DEVELOPED A POWERPOINT PRESENTATION TO EXPLAIN PROFICIENCY TESTING AND ALTERNATIVE ASSESSMENT PROTOCOL TO THE FOLKS IN THE CLIA LAB?
ERIKA CHEUNG: NO. I WAS NOT A PART OF THAT.
JUDGE DAVILA: YES. WOULD YOU LIKE THE WITNESS TO LOOK AT THIS TO SEE IF IT REFRESHES HER RECOLLECTION ON THIS TOPIC?
MR. WADE: I WAS JUST GOING TO DIRECT YOU -- TAKE A LOOK AT THE DOCUMENT IN THE POWERPOINT AND JUST SEE IF THAT REFRESHES YOUR RECOLLECTION THAT DRS. ROSENDORFF AND PANDORI PREPARED A PREPARED A POWERPOINT PRESENTATION TO EXPLAIN THE PROFICIENCY TESTING AND THE AAP POLICIES FOR THE EDISON DEVICES?
ERIKA CHEUNG: I HAD NEVER SEEN THIS DOCUMENT WHEN I WAS AT THE COMPANY.
JUDGE DAVILA: ALL RIGHT. THANK YOU. MR. BOSTIC, DO YOU HAVE SOME REDIRECT?
MR. BOSTIC: YES, YOUR HONOR.
JUDGE DAVILA: LADIES AND GENTLEMEN, FEEL FREE TO STAND UP AND STRETCH WHILE WE DO THE TRANSITION HERE. I WILL TELL YOU THAT WE WILL TAKE OUR BREAK AT 11:00 THIS MORNING. IN ABOUT 40 MINUTES OR SO WE WILL TAKE OUR MORNING BREAK.
(STRETCHING.)
JUDGE DAVILA: ALL RIGHT. THANK YOU. PLEASE BE SEATED EVERYONE. MR. BOSTIC, YOU HAVE REDIRECT?
MR. BOSTIC: YES, YOUR HONOR. THANK YOU.
REDIRECT EXAMINATION BY MR. BOSTIC:
MR. BOSTIC: GOOD MORNING, MS. CHEUNG.
ERIKA CHEUNG: GOOD MORNING.
MR. BOSTIC: I'D LIKE TO ASK A FEW FOLLOW UP TOPICS THAT YOU DISCUSSED WITH MR. WADE.
ERIKA CHEUNG: OKAY.
MR. BOSTIC: FIRST, YOU TESTIFIED YESTERDAY THAT THE VALIDATION PROCESS WOULD NORMALLY TAKE PLACE OVER MONTHS AND YEARS; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOU TESTIFIED THAT AT THERANOS IT TOOK PLACE ON A SHORTER TIMEFRAME. AM I STATING THAT CORRECTLY?
ERIKA CHEUNG: SO TO BE SPECIFIC, FOR EXAMPLE, FOR PRECISION, PRECISION IS AN EXPERIMENT THAT WE WOULD RUN OVER THE COURSE OF THREE MONTHS, OR IT'S STATED THAT YOU SHOULD RUN IT OVER THREE MONTHS. BUT WHAT WE DID AT THERANOS IS TRY AND GET IT DONE AS SOON AS POSSIBLE. SO DEPENDING ON HOW MANY SHIFTS WE HAD WITH HOW MANY PEOPLE AND HOW MANY ISSUES WE HAD, THAT WOULD BE CONDENSED DOWN TO A SHORTER TIME PERIOD.
MR. BOSTIC: WHAT WAS YOUR UNDERSTANDING AT THE TIME AS TO WHY THOSE VALIDATION PROCESSES AT THERANOS WERE TAKING PLACE OVER A SHORTER TIME PERIOD?
ERIKA CHEUNG: BECAUSE THEY WERE TRYING TO GET AS MANY TESTS AVAILABLE TO THE CLINICAL LAB AS POSSIBLE. SO, FOR EXAMPLE, WE HAD A BIG PUSH FOR ALL OF THE THYROID TESTS SO WE COULD DO THE PANEL. SO WE WERE TRYING TO FINISH UP ALL OF THE VALIDATION EXPERIMENTS AS QUICKLY AS POSSIBLE SO THAT THEY COULD GO LIVE WITHIN THE CLINICAL LAB.
MR. BOSTIC: AM I CORRECT THAT THE TIME PERIOD WE'RE TALKING ABOUT HERE IS AFTER THERANOS HAD ALREADY STARTED OFFERING PATIENT TESTING TO THE PUBLIC?
ERIKA CHEUNG: YES.
MR. BOSTIC: BUT IT WAS AN ONGOING GOAL TO GET AS MANY TESTS WORKING ON THE THERANOS DEVICE AS POSSIBLE; IS THAT WHAT YOU'RE SAYING?
ERIKA CHEUNG: YES.
MR. BOSTIC: DID THAT CONTINUE TO BE THE GOAL IN THE R&D LAB THROUGHOUT YOUR TIME AT THE COMPANY?
ERIKA CHEUNG: THE GOAL WAS TO GET AS MANY ASSAYS AS QUICKLY AS POSSIBLE OVER TO THE CLINICAL LAB, YES.
MR. BOSTIC: AND IN PARTICULAR, ARE WE TALKING ABOUT FINGERSTICK ASSAYS?
ERIKA CHEUNG: WE'RE TALKING ABOUT FINGERSTICK ASSAYS IN RELATION TO THE EDISON DEVICES SPECIFICALLY.
MR. BOSTIC: AND DESPITE THAT CONTINUING EFFORT AND THAT BEING THE GOAL, YOUR TESTIMONY IS THAT NO MORE THAN A DOZEN TESTS WERE EVER ACTUALLY PERFORMED ON THE EDISON DEVICE DURING YOUR TIME AT THE COMPANY?
ERIKA CHEUNG: CORRECT.
JUDGE DAVILA: MR. BOSTIC, YOU CAN FRAME YOUR QUESTIONS APPROPRIATELY. THANK YOU.
MR. BOSTIC: UNDERSTOOD. THANK YOU, YOUR HONOR.
MR. BOSTIC: MS. CHEUNG, A FEW MINUTES AGO YOU LOOKED AGAIN AT THE TEST MENU FOR THE TESTS THAT WERE OFFERED BY THERANOS DURING YOUR TIME AT THE COMPANY; CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: AND YOU SAW AT THE TOP OF THAT FORM THAT THERE WERE CHECK BOXES WHERE THE PERSON ORDERING THE TEST COULD SELECT BETWEEN, FOR EXAMPLE, FINGERSTICK VERSUS VEIN SAMPLE; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WERE ALL OF THE TESTS AVAILABLE ON THAT FORM OFFERED BY THERANOS ON FINGERSTICK SAMPLES?
ERIKA CHEUNG: NO.
MR. BOSTIC: LOOKING AT THAT LIST OF HUNDREDS OF TESTS THAT THERANOS OFFERED, APPROXIMATELY WHAT PROPORTION OF THEM COULD ACTUALLY BE CONDUCTED ON FINGERSTICK?
ERIKA CHEUNG: BY THE EDISON DEVICES OR BY THE MODIFIES OR --
MR. BOSTIC: LET'S START AND BREAK THAT OUT. AND SAY SO FIRST OF THAT LIST A COUPLE HUNDRED OR SEVERAL HUNDRED TESTS --
ERIKA CHEUNG: RIGHT.
MR. BOSTIC: -- HOW MANY COULD BE PERFORMED ON THE EDISON DEVICE BY FINGERSTICK?
ERIKA CHEUNG: SO WHILE I WAS WORKING THERE WHAT COULD BE PERFORMED BY FINGERSTICK WITH THE EDISON DEVICES WAS ANYWHERE BETWEEN FOUR TO NINE FOR THE EDISON DEVICES.
MR. BOSTIC: AND IF WE EXPAND THAT LIST TO INCLUDE EVERYTHING THAT THE COMPANY COULD DO ON A FINGERSTICK SAMPLE USING A MODIFIED THIRD PARTY DEVICE, FOR EXAMPLE?
ERIKA CHEUNG: RIGHT.
MR. BOSTIC: WOULD THAT THEN ENCOMPASS THE REST OF THE ENTIRE LIST OF SEVERAL HUNDRED?
ERIKA CHEUNG: NO.
MR. BOSTIC: WOULD IT COME CLOSE TO ENCOMPASSING THAT LIST OF SEVERAL HUNDRED TESTS?
ERIKA CHEUNG: NO.
MR. BOSTIC: DOES THAT MEAN THEN THAT THOSE CHECK BOXES AT THE TOP -- LET ME START AGAIN. DOES THAT MEAN THEN THAT EVEN IF A DOCTOR OR A PATIENT SELECTED A FINGERSTICK OPTION AT THE TOP OF THAT FORM, IF THEY SELECTED ONE OR MORE TESTS THAT COULD NOT BE RUN ON A FINGERSTICK SAMPLE, THEY COULD NOT PERFORM THEIR TESTS BY FINGERSTICK; IS THAT CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: GOING BACK TO THE TOPIC OF VALIDATION BRIEFLY. MR. WADE ASKED YOU ABOUT STANDARDS GOVERNING THE VALIDATION PROCESS. DO YOU RECALL THAT?
ERIKA CHEUNG: FOR THE OUTLIER PROCESS OR FOR THE --
MR. BOSTIC: GENERALLY SPEAKING.
ERIKA CHEUNG: GENERALLY.
MR. BOSTIC: STANDARDS CONCERNING VALIDATION TOLERANCES FOR DIFFERENT ASSAYS --
ERIKA CHEUNG: YES.
MR. BOSTIC: -- HE ASKED YOU WHETHER YOU KNEW OR WERE FAMILIAR WITH THE STANDARDS FOR THAT VALIDATION PROCESS; CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: AND WHEN YOU WERE AT THERANOS AND WORKING ON THESE ISSUES, WERE YOU ABLE TO REFERENCE THOSE STANDARDS?
ERIKA CHEUNG: REFERENCE THE STANDARDS OF THE VALIDATION PROCESS?
MR. BOSTIC: YES.
ERIKA CHEUNG: IN THE RESEARCH AND DEVELOPMENT LAB?
MR. BOSTIC: CORRECT.
ERIKA CHEUNG: UM, I DON'T REMEMBER.
MR. BOSTIC: AND DURING THE VALIDATION PROCESS THERE ARE -- OR LET ME ASK, DURING THE VALIDATION PROCESS, THERE ARE STANDARDS THAT GOVERN -- ACTUALLY, I'LL MOVE ON. WHEN THE VALIDATION PROCESS IS CONCLUDED AND A TEST IS MOVED INTO THE CLINICAL LAB AND CLINICAL PATIENT TESTING BEGINS --
ERIKA CHEUNG: YES.
MR. BOSTIC: -- IS THAT THE END OF THE QUESTION WHEN IT COMES TO THE ACCURACY AND PERFORMANCE OF THAT TEST?
ERIKA CHEUNG: NO.
MR. BOSTIC: WHY NOT?
ERIKA CHEUNG: BECAUSE YOU MONITOR THE ACCURACY AND THE PRECISION OF THE PERFORMANCE ONGOING. SO THE QUALITY CONTROLS ARE A GOOD INDICATION OF, YOU KNOW, ARE YOU HITTING YOUR ACCURACY TARGETS? ARE YOU GETTING PRECISE ENOUGH RESULTS? BECAUSE IT'S A WAY IN WHICH YOU COULD HAVE CONTINUITY WITH YOUR SYSTEM OUTSIDE OF WHAT WE HAD DONE FOR THE VALIDATION EXPERIMENTS, AND THE VALIDATION REPORTS THAT WERE GENERATED BY THE RESEARCH AND DEVELOPMENT LAB.
MR. BOSTIC: THE QUALITY CONTROL PROCESS THAT IS ONGOING, THAT TAKES PLACE AFTER VALIDATION IS ALREADY CONCLUDED?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: DURING YOUR TIME AT THERANOS, HOW SOON AFTER YOU BEGAN PARTICIPATING IN PATIENT TESTING DID YOU BECOME CONCERNED ABOUT THE ACCURACY OF THE THERANOS TESTS THAT YOU WERE WORKING ON?
ERIKA CHEUNG: I BECAME CONCERNED PROBABLY ABOUT A MONTH IN WITH THE VITAMIN D SAMPLES BECAUSE WE HAD SEEN A LOT OF VARIABILITY WITH THE VITAMIN D SAMPLES BOTH WITHIN VALIDATION AND WITH ACTUALLY TESTING THE PATIENT SAMPLES AND THE QUALITY CONTROLS. SO IT WAS ABOUT ROUGHLY A MONTH IN. SO I WOULD SAY NOVEMBER OF 2013.
MR. BOSTIC: AND WERE THE CONCERNS THAT YOU HAD ABOUT THE ACCURACY OF THE TESTS BASED ON SOMETHING THAT YOU SAW IN THE VALIDATION PROCESS OR THE ACTUAL PERFORMANCE OF THE TESTS WHEN APPLIED TO PATIENT SAMPLES?
ERIKA CHEUNG: BOTH.
MR. BOSTIC: YOU HAD A CONVERSATION WITH MR. WADE ABOUT THE WORK THAT YOU DID RESPONDING TO QUALITY CONTROL FAILURES AND HOW THAT WAS TIME CONSUMING. DO YOU RECALL SAYING THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND HOW TIME CONSUMING WAS IT? WAS IT SO TIME CONSUMING THAT IT ACTUALLY IMPACTED THE FLOW OF SAMPLES THROUGH THE LAB IN YOUR EXPERIENCE?
ERIKA CHEUNG: FOR BEING ABLE TO TROUBLESHOOT A QUALITY CONTROL ISSUE?
MR. BOSTIC: YES.
ERIKA CHEUNG: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN HOW THAT HAPPENED?
ERIKA CHEUNG: SO WHENEVER WE HAD A QUALITY CONTROL FAILURE, YOU HAD TO GO THROUGH A SERIES OF STEPS IN ORDER TO FIGURE OUT WHAT THE ISSUE WAS. WAS IT A REAGENT ISSUE? WAS IT SOME SORT OF DEVICE ISSUE? WAS IT SOME SORT OF RANDOM ISSUE? AND IF YOU COULD NOT RESOLVE WHAT IT WAS, YOU WOULD HAVE TO RECALIBRATE THE WHOLE DEVICE AND REESTABLISH THE QC RANGES. SO ANY TIME YOU HAD TO RECALIBRATE, KIND OF LIKE THAT DOCUMENT THAT MR. WADE WAS SHOWING WITH THE CALIBRATION WITH ALL OF THESE STANDARDS, YOU HAVE 12 OF THEM, A DIFFERENT CONCENTRATION, YOU HAVE TO RUN THEM WHICH TAKES 12 HOURS, 14 HOURS, AND THEN THAT'S IF EVERYTHING GOES RIGHT AND YOU'RE RUNNING THEM BACK TO BACK TO BACK. SOME OF US, IF WE COULD NOT TAKE SHIFTS, IT WOULD BE THE CASE THAT WE'RE WORKING 14 HOURS, 16 HOURS JUST TO GET IT RECALIBRATED.
AND THEN YOU HAVE TO REESTABLISH THE QC RANGES, WHICH IS 1 TO 3 DIFFERENT RANGES, AND YOU RUN THOSE 6 TO 8 TIMES, SO THAT CAN TAKE ANYWHERE IF YOU'RE DOING TWO SAMPLES TIMES 6, 6, 12, THAT'S AN ADDITIONAL 12, 14 HOURS. AND THEN THE DEXTER CALIBRATION -- AGAIN, THIS IS IF YOU DO EVERYTHING BACK TO BACK TO BACK TO BACK AND YOU GET THE TIMING RIGHT WHERE THE NEXT ASSOCIATE COMES IN AND SO YOU DON'T HAVE TO WORK FOR WHATEVER IT IS, THE LIKE 24 TO 83 HOURS, WHATEVER THAT IS. SO IF A PATIENT COMES IN, WE WERE SUPPOSED TO GET THAT PATIENT THE RESULT IN TWO HOURS, IF WE HAD TO RECALIBRATE THE WHOLE SYSTEM, IT WOULD BE DELAYED BY LIKE TWO OR THREE DAYS BECAUSE IT WAS SUCH A TIME CONSUMING PROCESS, AND THAT'S TYPICALLY WHAT THE WORKFLOW WOULD LOOK LIKE. THE REASON IT BECAME SUCH AN ISSUE BECAUSE IT KEPT JAMMING UP OUR WORKFLOW AS WELL WHERE WE'RE CONSTANTLY HAVING TO RECALIBRATE, BUT IT WOULD TAKE DAYS IN ORDER TO GET THAT DONE. SO ONE PATIENT SAMPLE WAS SUPPOSED TO BE OUT IN THREE HOURS, AND YOU HAVE THIS THREE DAY WINDOW THAT YOU'RE HOPING TO GET YOUR SYSTEM BACK AND RUNNING WHERE PEOPLE ARE RUNNING AROUND THE CLOCK TO GET IT BACK INTO THE PROPER STATE.
MR. BOSTIC: AND WERE THOSE PROBLEMS WITH THE MACHINE PERFORMANCE COMMON ENOUGH, IN FACT, THAT IT WAS A CONSTANT PROBLEM GOING THROUGH THIS PROCESS AND DELAYING PATIENT SAMPLES?
ERIKA CHEUNG: YEAH. I MEAN, WE HAD PEOPLE SLEEPING IN THEIR CAR BECAUSE IT WAS JUST TAKING TOO LONG. EVERY THREE DAYS YOU WERE HAVING TO JUST RUN THESE SAMPLES OVER AND OVER AND OVER. SO IT WAS HAPPENING VERY FREQUENTLY.
MR. BOSTIC: MR. WADE CONFIRMED WITH YOU THAT WHEN A DEVICE DID FAIL QC, THIS PROCESS WOULD BE TAKEN ON AND THE DEVICE WOULD NOT BE USED FOR PATIENT SAMPLE AGAIN UNTIL THE ISSUE WAS APPARENTLY RESOLVED; IS THAT CORRECT?
ERIKA CHEUNG: THAT'S CORRECT.
MR. BOSTIC: AND IN YOUR EXPERIENCE WOULD THAT PRACTICE ADDRESS CONCERNS ABOUT THE PERFORMANCE OF THE MACHINE IN BETWEEN QUALITY CONTROL CHECKS?
ERIKA CHEUNG: NO, BECAUSE WE ONLY DID QUALITY CONTROLS AT THE BEGINNING OF THE DAY. SO SOME LABS WILL DO THEM AT THE BEGINNING OF EACH SHIFT, AND AT THERANOS WE HAD TWO SHIFTS. WE HAD A DAY SHIFT, SOMETIMES AN AFTERNOON SHIFT, AND A NIGHT SHIFT. SO IT ONLY ADDRESSED BASICALLY WHAT THE QUALITY OF IT WAS AT THE BEGINNING OF THE DAY. AND SOMETIME YOU EVEN RUN QUALITY CONTROLS MORE FREQUENTLY, ESPECIALLY IF IT'S A MORE SERIOUS DIAGNOSES. SO, FOR EXAMPLE, IF YOU'RE RUNNING INFECTIOUS DISEASE, YOU'LL ATTEMPT TO RUN THEM BEFORE YOU RUN EVERY INFECTIOUS DISEASE SAMPLE JUST TO BE SURE AND GIVE YOURSELF A LEVEL OF CONFIDENCE IS THE SYSTEM WORKING RIGHT AT THIS MOMENT VERSUS AT THE BEGINNING OF THE DAY? SO AT THERANOS THE STANDARD PRACTICE WAS THAT WE WOULD RUN IT AT THE BEGINNING IN THE DAY AND UNLESS THERE WAS SOME WEIRD SHIFT OVER WHERE MAYBE THE TECHNICIAN HAD MORE TIME AND SO THEY WOULD JUST RUN THEM JUST BECAUSE. BUT IT WASN'T STANDARD PRACTICE TO RUN THEM MULTIPLE TIMES A DAY OR MULTIPLE -- AT THE BEGINNING OF EACH SHIFT.
MR. BOSTIC: I'D LIKE TO ASK YOU JUST A COUPLE MORE QUESTIONS ABOUT YOUR PRACTICES WHEN IT CAME TO EMAIL BUSINESS RECORDS AT THERANOS.
ERIKA CHEUNG: YES.
MR. BOSTIC: YOU TESTIFIED BEFORE THAT EMAILS WERE PRESERVED AT THERANOS; IS THAT CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: AND AS A MEMBER OF THE LAB STAFF SENDING AND RECEIVING THESE EMAILS, WERE YOU UNDER A DUTY OR AN OBLIGATION TO PRESERVE THESE RECORDS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND FOR WHAT PURPOSE WERE THEY PRESERVED?
ERIKA CHEUNG: TO REFERENCE BACK, TO BE ABLE TO COMMUNICATE WITH OTHER LAB MEMBERS, TO BE ABLE TO MAKE SURE THAT ANYTHING THAT WAS COMMUNICATED BY EMAIL THAT NEEDED TO BE TRANSCRIBED, THERE WAS A WAY IN WHICH WE COULD TRANSCRIBE THAT INFORMATION IN ORDER TO JUST -- AS WE SAW SOMETIMES, WE WOULD GET EMAILS TELLING US THAT NEW SOP'S WERE UPDATED AND THAT WE HAD TO BE ABLE TO CREATE NEW INFRASTRUCTURE FOR NEW TESTS TO BE ABLE TO KEEP TRACK OF THOSE THINGS BECAUSE SOMETIMES IT COULD BE VERY DYNAMIC AND VERY CHANGING, SO WE NEEDED TO HAVE A THREAD IN ORDER TO FIGURE OUT WHEN OUR CERTAIN ASSAYS ONBOARDED AT WHAT CERTAIN TIME PERIODS.
MR. BOSTIC: WAS IT YOUR PRACTICE WHEN YOU WERE AT THERANOS TO FOLLOW OR ADHERE TO THAT DUTY AND PRESERVE THE EMAILS THAT YOU WERE SENDING AND RECEIVING?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DID YOU UNDERSTAND THAT TO BE THE PRACTICE OF OTHERS AT THERANOS PURSUANT TO THAT SAME DUTY?
ERIKA CHEUNG: YES.
MR. BOSTIC: IF I COULD USE THE ELMO.
COURT CLERK: IS THIS JUST FOR THE WITNESS?
MR. BOSTIC: SORRY. I'D LIKE TO SHOW EXHIBIT 9925, WHICH IS IN EVIDENCE.
COURT CLERK: OKAY.
BY MR. BOSTIC:
MR. BOSTIC: MS. CHEUNG, DO YOU REMEMBER REVIEWING EXHIBIT 9925 ON THE SCREEN IN FRONT OF YOU?
ERIKA CHEUNG: YES.
MR. BOSTIC: DO YOU REMEMBER REVIEWING PORTIONS OF THIS DOCUMENT WITH MR. WADE?
ERIKA CHEUNG: YES.
MR. BOSTIC: I'D LIKE TO SHOW YOU PAGE 6 OF 21 OF THIS DOCUMENT. THIS IS A PAGE ENDING IN BATES 4013790. IS THAT SHOWING UP ON YOUR SCREEN?
ERIKA CHEUNG: YES.
MR. BOSTIC: I'D LIKE TO DRAW YOUR ATTENTION SPECIFICALLY TO THE LANGUAGE UNDER SECTION 8 OF THIS DOCUMENT WHERE IT SAYS THERANOS SYSTEM. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: IN THIS PARAGRAPH THERE'S LANGUAGE THAT SAYS, "THE SYSTEM CAN BE OPERATED WITH MINIMAL TRAINING AND PERFORMS MULTIPLE TESTS ON A VARIETY OF SAMPLE TYPES." DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IT ALSO SAYS, "THE SYSTEM ENABLES RESULTS IN UNDER AN HOUR WITH PRECISION AND ACCURACY EQUIVALENT TO TRADITIONAL CLINICAL LABORATORY ANALYZER." DID YOU READ THAT CORRECTLY?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND AS TO THE SECOND CLAIM THAT THE SYSTEM ENABLES RESULTS IN UNDER AN HOUR WITH PRECISION AND ACCURACY EQUIVALENT TO TRADITIONAL CLINICAL LABORATORY ANALYZER, WAS THAT CONSISTENT WITH YOUR EXPERIENCE WHILE YOU WERE AT THE THERANOS COMPANY?
ERIKA CHEUNG: NO.
MR. BOSTIC: AND HOW ABOUT THE CLAIM THAT THE SYSTEM CAN BE OPERATED WITH MINIMAL TRAINING? YOU DESCRIBED BEFORE THE STEPS INVOLVED IN OPERATING THE EDISON ANALYZER. CAN YOU JUST RUN THROUGH THOSE AGAIN AT A HIGH LEVEL?
ERIKA CHEUNG: AT A HIGH LEVEL PROCESS FOR THE EDISON DEVICES?
MR. BOSTIC: YES. NOT IN DETAIL, BUT GIVE US AN OVERVIEW.
ERIKA CHEUNG: YEAH. SO ESSENTIALLY YOU WOULD HAVE TO UNDERSTAND HOW TO SORT THE BLOOD SAMPLE TO MAKE SURE YOU GOT IT ACCURATELY AND IT WAS PROCESSED THE SAME WAY. SO SOMETIMES YOU HAVE THE WHOLE BLOOD, AND YOU HAVE TO CENTRIFUGE IT, AND YOU HAVE TO JUST COLLECT THE SERA. SO THAT'S STEP ONE IS UNDERSTANDING HOW TO USE THE SORTING ROBOT AND TO BE ABLE TO UNDERSTAND WHAT TYPE OF BLOOD THAT YOU NEED OR WHAT TYPE OF SAMPLE THAT YOU NEED. THEN YOU HAVE TO RUN IT THROUGH A TECAN, SO THIS IS THE ROBOTICS LIQUID HANDLING SYSTEM, AND MAKE SURE YOU GET THE RIGHT PROTOCOL AND THAT EVERYTHING IS SET UP THE RIGHT WAY AND THE TRAY BECAUSE THE ROBOT GOES INTO VERY SPECIFIC PLACES AND IF YOU MESS IT UP IT WILL GO INTO THE WRONG WELL. AND THEN YOU TAKE IT OVER TO THE EDISON DEVICE, AND THEN YOU SCAN IT, AND PUT IT THROUGH THE SYSTEM, AND RUN IT, AND THEN EXTRACT THE DATA, AND THEN ANALYZE THE DATA. THERANOS HAD DIFFERENT PROCEDURES AT DIFFERENT TIMES SO THERE WERE THE CAPSYS CARTRIDGES THAT WERE REFERRED TO A COUPLE OF TIMES, AND THOSE WERE PREFILLED WITH REAGENTS, BUT WHEN I FIRST GOT THERE THEY WERE ACTUALLY HAND FILLED, AND SO WE HAD TO ACTUALLY MANUALLY PIPET A WHOLE BUNCH OF REAGENTS INTO THE ACTUAL CARTRIDGES IN ORDER TO RUN THEM AT THE VERY BEGINNING OF MY WORK THERE. SO THAT'S ACTUALLY QUITE COMPLICATED. SO YOU HAVE TO HAVE A SCHEMATIC AND UNDERSTAND EXACTLY WHAT AND HOW MUCH OF A CERTAIN SOLUTION GOES INTO EACH WELL IN THE EXACT SPOT SO THE ASSAY CAN RUN PROPERLY. SO IT WAS -- THAT'S GENERALLY THE PROCESS.
MR. BOSTIC: WHEN YOU WERE AT THERANOS, DID YOU ALSO HAVE OCCASION TO PROCESS BLOOD SAMPLES ON THE UNMODIFIED THIRD PARTY DEVICES LIKE THE SIEMENS ADVIA?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHEN IT CAME TO A NUMBER OF STEPS IN THE PROCESS AND HOW COMPLICATED IT WAS, HOW DID THE PROCESS ON THE SIEMENS ADVIA COMPARE TO THE THERANOS ANALYZER?
ERIKA CHEUNG: THE SIEMENS ADVIA WAS CONSIDERABLY LESS COMPLICATED. MOST OF THE TIME YOU JUST HAD TO PUT A BAR CODE LABEL ONTO THE VENOUS TUBE AND YOU HAD TO STICK IT INTO THE MACHINE, AND MAYBE YOU WOULD HAVE TO CHECK THE QC'S, THAT THEY WERE PERFORMED ACCURATELY BEFORE YOU COULD RUN THE SAMPLE, BUT OTHER THAN THAT IT WOULD JUST SCAN THE BAR CODE AND SHUFFLE THEM AND BE ABLE TO RUN EVERYTHING AUTOMATICALLY.
MR. BOSTIC: HOW WOULD YOU COMPARE THE LEVEL OF AUTOMATION IN THE SIEMENS ADVIA COMPARED TO THE THERANOS ANALYZER?
ERIKA CHEUNG: THE SIEMENS ADVIA WAS CONSIDERABLY MORE SOPHISTICATED AND A PRODUCT OF, YOU KNOW, A LOT OF ENGINEERING AND JUST HAD A LOT OF AUTOMATION BUILT INTO THE PROCESS. THERANOS THERE WASN'T -- THERE WAS A LACK OF AUTOMATION I WOULD SAY IN COMPARISON.
MR. BOSTIC: THERE WAS ALSO SOME DISCUSSION ABOUT THE PRICES AT WHICH THERANOS OFFERED ITS TESTS. DO YOU RECALL THAT TESTIMONY?
ERIKA CHEUNG: YES.
MR. BOSTIC: DID THE LOW PRICES OFFERED BY THERANOS AMELIORATE OR REDUCE YOUR CONCERNS ABOUT THE ACCURACY OF THE TESTS IN ANY WAY?
ERIKA CHEUNG: NO.
MR. BOSTIC: WHY NOT?
ERIKA CHEUNG: JUST BECAUSE THEY'RE LESS -- YOU SHOULDN'T -- JUST BECAUSE THEY'RE LESS EXPENSIVE DOESN'T MEAN THAT YOU SHOULD GIVE SOMEONE FALSE INFORMATION ABOUT THEIR HEALTH STATUS. YEAH, SO YOU SHOULD BE ABLE -- IF YOU ARE PROVIDING LAB TESTING SERVICES FOR A PATIENT, IT STILL SHOULD BE OF A QUALITY STANDARD THAT THEY CAN HAVE SOME CONFIDENCE THAT THERE IS ACCURACY TO THE RESULT THAT THEY'RE RECEIVING. IT SHOULDN'T BE THE CASE THAT BECAUSE YOU PAY LESS THIS MEANS THAT YOU GET A LESS QUALITY RESULT.
MR. BOSTIC: THERE WAS SOME CONVERSATION OR SOME DISCUSSION DURING YOUR DIRECT AND YOUR CROSS-EXAMINATION ABOUT THERANOS'S PRACTICE OF REMOVING OUTLIERS FROM DATA SETS. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THAT PROCESS OF OUTLIER REMOVAL WHERE A CERTAIN NUMBER OF OUTLIERS WERE REMOVED FROM A DATA SET?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: DID THAT PROCESS NEED TO BE EMPLOYED WHEN YOU WERE USING THE SIEMENS ADVIA DEVICES OR OTHER THIRD PARTY DEVICES AT THERANOS?
ERIKA CHEUNG: THE OUTLIER DELETION PROCESS?
MR. BOSTIC: CORRECT.
ERIKA CHEUNG: I COULDN'T SPEAK FOR THE CYTOMETER, THAT'S NOT WHAT I SAW FOR GENERAL CHEMISTRY. IT WAS SOMETHING VERY SPECIFIC TO THE EDISON DEVICES.
MR. BOSTIC: MR. WADE ALSO ASKED YOU ABOUT THE TIME PERIOD AFTER YOU LEFT THE COMPANY AND SOME CALLS YOU GOT FROM HR AT THERANOS; IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. BOSTIC: AND WHY DID YOU NOT RETURN THOSE CALLS?
ERIKA CHEUNG: I DIDN'T, I DIDN'T RETURN THE CALLS BECAUSE, ONE, I DIDN'T WORK FOR THE COMPANY ANYMORE, AND, HONESTLY, WHEN I HEARD MONA'S VOICE AND HOW SCARED SHE SOUNDED, IT JUST REMINDED ME OF HOW SCARED I WAS WORKING FOR THAT COMPANY, AND SO I JUST FELT THAT I DIDN'T HAVE TO, IT WASN'T MY RESPONSIBILITY TO PICK UP THE PHONE AND TALK TO THESE PEOPLE, THAT I HAD THE RIGHT TO NOT SPEAK TO THEM.
MR. BOSTIC: NO FURTHER QUESTIONS. THANK YOU, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. MAY THIS WITNESS BE EXCUSED?
MR. BOSTIC: YES, YOUR HONOR. AND FROM THE GOVERNMENT'S PERSPECTIVE, NOT SUBJECT TO RECALL.
JUDGE DAVILA: ALL RIGHT. THANK YOU. THANK YOU VERY MUCH. YOU'RE EXCUSED. YOU MAY STAND DOWN.
ERIKA CHEUNG: THANK YOU.
JUDGE DAVILA: JUST LEAVE EVERYTHING. DOES THE GOVERNMENT HAVE ANOTHER WITNESS TO CALL?
MR. LEACH: YES, YOUR HONOR. THE UNITED STATES CALLED SUREKHA GANGADKHEDKAR.
JUDGE DAVILA: ALL RIGHT. THANK YOU. FOLKS, YOU CAN STAND UP AND STRETCH FOR JUST A MINUTE IF YOU WOULD LIKE. WE'RE GOING TO TAKE OUR BREAK IN ABOUT 15 OR 20 MINUTES, BUT FEEL FREE TO STAND UP AND STRETCH IF YOU WOULD LIKE.
(STRETCHING.)
MR. LEACH: YOUR HONOR, MAY I RETRIEVE THE BINDERS?
JUDGE DAVILA: YES, YES, YOU CAN GET YOUR THINGS.
(STRETCHING.)
JUDGE DAVILA: GOOD MORNING. IF YOU COULD STAND FOR JUST A MINUTE, PLEASE. IF YOU COULD FACE OUR COURTROOM DEPUTY. SHE'S RIGHT IN FRONT OF YOU. IF YOU COULD RAISE YOUR RIGHT HAND, SHE HAS A QUESTION FOR YOU.
(GOVERNMENT'S WITNESS, SUREKHA GANGAKHEDKAR, WAS SWORN.)
ERIKA CHEUNG: YES.
JUDGE DAVILA: THANK YOU. LET ME INVITE YOU TO HAVE A SEAT HERE. MAKE YOURSELF COMFORTABLE. FEEL FREE TO ADJUST THE CHAIR AND MICROPHONE AS YOU NEED. THE MICROPHONE DOES MOVE. I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE. WHEN YOU ARE COMFORTABLE, WOULD YOU STATE YOUR NAME, PLEASE.
ERIKA CHEUNG: MY NAME IS SUREKHA GANGADKHEDKAR. S-U-R-E-K-H-A, AND THE LAST NAME IS G-A-N-G-A-K-H-E-D-K-A-R.
JUDGE DAVILA: THANK YOU VERY MUCH. COUNSEL.