Erika Cheung — Direct/Cross (Continued)
1,792 linesDIRECT EXAMINATION (RESUMED) BY MR. BOSTIC:
MR. BOSTIC: WELCOME BACK, MS. CHEUNG.
ERIKA CHEUNG: THANK YOU.
MR. BOSTIC: I'D LIKE TO CIRCLE BACK TO A TOPIC WE BRIEFLY TOUCHED ON YESTERDAY. DID THERANOS EVER RUN DEMONSTRATIONS OF ITS TECHNOLOGY FOR VIP VISITORS TO THE COMPANY?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND BASED ON YOUR UNDERSTANDING AT THE TIME, WHAT KINDS OF VISITORS WERE THOSE?
ERIKA CHEUNG: THEY WERE INVESTORS OR PATIENTS.
MR. BOSTIC: PEOPLE THAT THE COMPANY WAS TRYING TO IMPRESS?
ERIKA CHEUNG: YES.
MR. BOSTIC: IS THERE A BINDER OF DOCUMENTS IN FRONT OF YOU?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WOULD YOU TURN TO EXHIBIT 1227 IN THAT BINDER, PLEASE. ONCE YOU'RE THERE, WOULD YOU LET ME KNOW IF YOU RECOGNIZE THAT DOCUMENT?
ERIKA CHEUNG: YES, ID O.
MR. BOSTIC: WHAT IS THE DOCUMENT MARKED AS 1227?
ERIKA CHEUNG: THIS IS AN EMAIL FROM UYEN DO EFFECTIVELY EXPLAINING THAT WE'LL HAVE A DEMO PATIENT AND THAT I'LL HAVE TO RUN IT, AND THEN IT GIVES ME THE WHOLE THREAD OF EMAILS BASICALLY LETTING ME KNOW OF ALL OF THE DEMO PATIENTS THAT WE WILL LIKELY RECEIVE WITHIN THE NEXT WEEK.
MR. BOSTIC: WERE EMAILS LIKE THESE TYPICALLY USED AT THERANOS FOR THE PURPOSE OF COORDINATING THESE DEMOS?
ERIKA CHEUNG: YEAH. YES.
MR. BOSTIC: AND WERE THEY THE MAIN METHOD OF COMMUNICATION FOR COORDINATING THESE DEMOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WERE DEMOS LIKE THESE A REGULAR PART OF THERANOS'S BUSINESS AT THE TIME?
ERIKA CHEUNG: YES.
MR. BOSTIC: WAS IT IMPORTANT IN THE EMAILS CONCERNING THESE DEMOS TO BE ACCURATE ABOUT THE DETAILS ABOUT HOW THE DEMOS WOULD BE RUN AND WHAT WOULD BE INVOLVED?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHY WAS IT IMPORTANT TO BE ACCURATE IN THESE EMAILS?
ERIKA CHEUNG: IT WAS IMPORTANT TO BE ACCURATE BECAUSE WE HAD TO MAKE SURE THAT THE SAMPLES WERE RUN PROPERLY, THAT THE RIGHT TEST ASSOCIATED WITH EACH OF THE DEMO SAMPLES WERE RUN BECAUSE WE HAD TO COORDINATE AMONGST DIFFERENT TEAMS. SO FOR THE EDISON TEAM, YOU KNOW, WE WERE IN CHARGE OF, SAY, THYROID STIMULATING HORMONE OR VITAMIN D, VERSUS ANOTHER TEAM WAS IN CHARGE OF A CHEM 14 PANEL OR A METABOLIC PANEL. AND SO IT WAS VERY CRUCIAL TO MAKE SURE THAT ALL OF US WERE ON THE SAME PAGE ABOUT WHAT PATIENT WAS COMING IN AT WHAT TIME, HOW MUCH TIME DID WE HAVE TO PROCESS IT, AND WHAT WERE THE SPECIFIC TESTS THAT NEEDED TO BE RUN ON THAT PATIENT AND WHO DID WE NEED TO DIRECT THAT INFORMATION TO, BECAUSE IT WAS TYPICALLY HANDLED BY THE PRODUCT MANAGERS INSTEAD OF A DIFFERENT SYSTEM WE USED FOR PATIENT RESULTS.
MR. BOSTIC: SO IN ESSENCE, WERE EMAILS LIKE THESE FUNCTIONING AS THE ORDER FORMS, FOR EXAMPLE, FOR THE TESTS THAT WERE GOING TO BE RUN?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DID THEY ALSO HAVE THE FUNCTION OF REPORTING RESULTS AND DISCUSSING ANY ISSUES THAT CAME UP DURING THE DEMOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: WERE THE EMAILS THEN PRESERVED SO THAT THEY COULD BE REFERRED TO LATER IF NEEDED?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WERE EMAILS LIKE THIS PREPARED CONTEMPORANEOUSLY, IN OTHER WORDS, AROUND THE TIME THAT THE ACTUAL DEMOS WERE OCCURRING?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, AT THIS TIME THE GOVERNMENT WOULD MOVE TO ADMIT EXHIBIT 1227.
JUDGE DAVILA: THANK YOU. IT WILL BE ADMITTED, AND I'LL NOTE OUR CONVERSATION PREVIOUSLY, MR. WADE.
(GOVERNMENT'S EXHIBIT 1227 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MAY WE PUBLISH?
JUDGE DAVILA: YES.
MR. BOSTIC: MS. HOLLIMAN, CAN WE PROJECT EXHIBIT 1227, AND LET'S START WITH PAGE 6 OF THAT EXHIBIT. IF WE CAN ZOOM IN ON THE TOP HALF. LET'S CAPTURE ALL OF THE TEXT. THANK YOU.
MR. BOSTIC: MS. CHEUNG, IS EXHIBIT 1227 SHOWING UP ON YOUR SCREEN?
ERIKA CHEUNG: YES.
MR. BOSTIC: THE FIRST EMAIL IS FROM SOMEONE NAMED DANIEL EDLIN. WHO WAS DAN EDLIN AT THERANOS?
ERIKA CHEUNG: DANIEL EDLIN WAS ONE OF THE PROJECT MANAGERS OR COORDINATORS MANAGERS.
MR. BOSTIC: AND IS THIS EMAIL DESCRIBING AN UPCOMING DEMO AS YOU PREVIOUSLY DISCUSSED?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IN THE EMAIL THERE'S A LINE THAT BEGINS THE "DEFAULT TEST LIST FOR ALL OF THESE DEMOS IS." DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND CAN YOU PLEASE READ INTO THE RECORD WHAT DEFAULT TESTS WOULD BE RUN FOR THESE DEMOS?
ERIKA CHEUNG: SO READ THE STATEMENT?
MR. BOSTIC: YES, PLEASE.
ERIKA CHEUNG: THE DEFAULT TEST LIST FOR ALL OF THESE DEMOS IS CHEM 14, LIPIDS, CBC, AND VITAMIN D/TSH/PSA.
MR. BOSTIC: CAN YOU EXPLAIN BRIEFLY BASED ON YOUR UNDERSTANDING WHAT THOSE ASSAYS OR TESTS WERE?
ERIKA CHEUNG: YES. SO CHEM 14 IS A GENERAL CHEMISTRY PANEL; LIPIDS IS ALSO A GENERAL CHEMISTRY PANEL; CBC IS A HEMATOLOGY SAMPLE; AND THEN VITAMIN D/TSH AND PSA ARE AN EDISON TEST. SO THEY WERE IMMUNOASSAYS, AND THAT'S THE BREAKDOWN OF THESE DIFFERENT TYPES OF TESTS.
MR. BOSTIC: YOU MENTIONED THAT SOME OF THESE WERE PANELS. WHAT DOES THAT MEAN WHEN A TEST IS A PANEL?
ERIKA CHEUNG: A PANEL IS ESSENTIALLY A WHOLE SERIES OF DIFFERENT TYPES OF TESTS. SO LIPIDS, LIKE, FOR EXAMPLE, CBC, IT WOULD BE YOUR RED BLOOD CELLS, IT WOULD BE YOUR WHITE BLOOD CELLS, AND IT WOULD ENCOMPASS NUMEROUS TESTS AND NUMEROUS POINTS OF INTEREST WITHIN THAT ONE NAME OF A PANEL.
MR. BOSTIC: AND WHICH OF THESE ASSAYS ARE PANELS AND WHICH ARE NOT?
ERIKA CHEUNG: THE PANELS ARE CHEM 14, LIPIDS, CBC. AND THE TESTS THAT ARE NOT PANELS ARE VITAMIN D, TSH, AND PSA.
MR. BOSTIC: SO, IN OTHER WORDS, THOSE LAST THREE ARE JUST SINGLE TESTS, WHERE THE PREVIOUS ONES ARE MULTIPLE TESTS IN GROUPS?
ERIKA CHEUNG: YES.
MR. BOSTIC: JUST TO BE CLEAR, IS THIS EMAIL CHAIN DISCUSSING A SERIES OF UPCOMING DEMOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: LOOKING AT THIS LIST OF ASSAYS, WHICH OF THESE ASSAYS COULD BE RUN ON THE THERANOS MANUFACTURED ANALYZER?
ERIKA CHEUNG: THE THERANOS MANUFACTURED DEVICE WAS THE EDISON DEVICE, AND THE ONLY TEST THAT THE EDISONS COULD RUN ARE VITAMIN D, TSH, AND PSA.
MR. BOSTIC: AND WHAT DEVICES DID THERANOS USE FOR THE PANELS, THE CHEM 14, THE LIPIDS, THE CBC IF THOSE COULD NOT BE RUN ON THE THERANOS MANUFACTURED DEVICE?
ERIKA CHEUNG: SO THERANOS UTILIZED THE SIEMENS ADVIA, THE MODIFIED SIEMENS ADVIA WHERE WE USED THE T-CUPS INSTEAD OF THE J-CUPS, AND THAT WAS THE CHEM 14 AND THE LIPIDS. AND THEN WE UTILIZED BD FORTESSA, THAT WAS A FLOW CYTOMETER, AND THE FLOW CYTOMETER WAS USED TO RUN CBC.
MR. BOSTIC: AND THOSE TWO DEVICES, WERE THEY MANUFACTURED BY COMPANIES OTHER THAN THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: SO DOES THAT MEAN THAT IF SOMEONE CAME IN FOR A DEMO AND HAD THESE ASSAYS RUN -- WELL, LET ME ASK, WOULD THEY GET BACK A REPORT OF THE RESULTS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WOULD THAT REPORT INCLUDE THREE RESULTS THAT WERE FROM A THERANOS MANUFACTURED ANALYZER AND SEVERAL ADDITIONAL RESULTS THAT WERE FROM NON-THERANOS MANUFACTURED ANALYZERS?
ERIKA CHEUNG: YES.
MR. BOSTIC: LET'S TURN TO PAGE 4 IN THIS EXHIBIT IF WE CAN. LET'S ZOOM IN ON THE MIDDLE THIRD ONCE WE GET TO PAGE 4. LET'S CAPTURE FROM THERE AND INCLUDE THAT ENTIRE EMAIL MESSAGE IF WE CAN. THAT'S GOOD. THANK YOU. IS THAT TEXT SHOWING UP ON YOUR SCREEN, MS. CHEUNG?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WE SEE HERE AN EMAIL IN THE SAME CHAIN FROM SOMEONE NAMED MAX FOSQUE. WHO WAS THAT AT THERANOS?
ERIKA CHEUNG: MAX FOSQUE WAS ALSO A PROGRAM OR PRODUCT MANAGER AT THERANOS.
MR. BOSTIC: IS THIS MESSAGE RELATED TO THAT SAME SERIES OF DEMOS THAT WE PREVIOUSLY DISCUSSED?
ERIKA CHEUNG: YES.
MR. BOSTIC: I'D LIKE TO DRAW YOUR ATTENTION TO THE SECTION OF HIS EMAIL WHERE HE LISTS SOME BULLET POINTS, AND THE THIRD ONE DOWN SAYS "TESTS INCLUDE: CBC AND CHEM 14, WITH VITAMIN D ADDED IF EVERYTHING IS GOING SMOOTHLY." DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS YOUR UNDERSTANDING OF WHAT THAT MEANT, "IF EVERYTHING IS GOING SMOOTHLY"?
ERIKA CHEUNG: SO TYPICALLY WE HAD A CERTAIN TIMEFRAME IN WHICH WE HAD TO RUN THESE SAMPLES. SO TYPICALLY WE WOULD TRY AND GET THE DEMO SAMPLES OUT WITHIN TWO HOURS. AND IF IT WAS THE CASE THAT WE WERE RUNNING OVERTIME BECAUSE MAYBE THE CBC, THE HEMATOLOGY TEAM OR THE CHEM PANEL WAS RUNNING LATE OR DELAYED FOR SOME REASON, THEN THEY WOULD JUST -- THEY WOULD STICK TO THEIR SAMPLES BEFORE US RECEIVING THE BLOOD SAMPLES SO WE COULD START PROCESSING THE VITAMIN D SAMPLE WITH THE EDISON DEVICES. SO IT'S TYPICALLY IN REFERENCE TO THE FACT OF ARE THINGS RUNNING ON TIME, ARE WE -- DID THE QC'S PASS BEFORE WE RAN THE DEMO. THERE WERE TYPICALLY DELAYS. WERE THERE ANY TYPE OF DELAYS? AND IF THERE WERE DELAYS, THEN WE WOULDN'T RUN THE EDISON TEST. THEY WERE TYPICALLY RAN LAST.
MR. BOSTIC: SO IF SOMETHING WENT WRONG IN THE PROCESS, THE TESTS RUN ON THE EDISON ANALYZER, ON THE THERANOS ANALYZER, WOULD BE ABANDONED AND INSTEAD THE DEMO WOULD ONLY INVOLVE THE THIRD PARTY DEVICES?
ERIKA CHEUNG: YES.
MR. BOSTIC: WHEN IT TALKS ABOUT EVERYTHING GOING SMOOTHLY AND YOU MENTIONED PROBLEMS OCCURRING, DID PROBLEMS FREQUENTLY OCCUR DURING DEMOS AND GENERAL TESTING AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: CAN YOU TELL ME ABOUT HOW THE WORKFLOW OPERATED IN THERANOS WITH THESE DEMOS? WHAT WOULD HAPPEN ONCE THE SAMPLE WAS ACTUALLY OBTAINED GIVEN THAT THESE DIFFERENT DEVICES NEEDED TO BE USED TO RUN THESE PANELS AND TESTS?
ERIKA CHEUNG: SO ONCE THE PHLEBOTOMIST HAD OBTAINED THE SAMPLES IN THE NANOTAINER, THE SMALL BLOOD COLLECTION UNIT, THEY WOULD BRING IT TO THE NORMANDY LAB, SO IT WAS A BACK LABORATORY ON THE BOTTOM FLOOR OF THE BUILDING AT 1601 SOUTH CALIFORNIA. WHAT WOULD HAPPEN IS IT WOULD COME DOWN TO THE SORTING STATION WHERE ALL TYPICALLY THREE OF THE TEAMS, THE CHEMISTRY TEAM, THE CYTOMETRY OR THE HEMATOLOGY TEAM, AND THE EDISON TEAM WOULD ALL WAIT ON STANDBY TO FIGURE OUT, OKAY, WHO GETS THE SAMPLE FIRST. AND BASICALLY THEY WOULD GRAB THE SAMPLE, COLLECT WHATEVER BLOOD THEY NEEDED USING THE TECAN MACHINE, BRING IT BACK TO THIS MAIN REFRIGERATOR, AND THEN WE AGAIN WOULD SORT OUT WHO GETS IT NEXT. AND THEN IT WOULD GO TO, SAY, THE HEMATOLOGY TEAM BECAUSE THERE ARE DIFFERENT TYPES OF PREPARATION THAT YOU HAVE TO DO FOR DIFFERENT TYPES OF TESTS. AND THEN IN THE CASE OF THE EDISONS, ONCE WE GOT THE SAMPLE, WE WOULD PUT IT THROUGH THE TECAN MACHINE, IT WOULD DISPENSE THE SMALL AMOUNT OF BLOOD IN THE DILUENT INTO THE CARTRIDGES, WE WOULD GRAB THE CARTRIDGES, TAKE THEM TO THE EDISON DEVICES, AND MAKE SURE THERE WAS A BAR CODE ON THEM, SCAN THE BAR CODE, AND MAKE SURE THERE WAS THE APPROPRIATE TEST, PUT THEM IN THE MACHINE, CLICK START. WE WOULD WAIT FOR IT TO PROCESS ANYWHERE FROM, LIKE, 45 MINUTES TO AN HOUR AND A HALF DEPENDING ON THE TEST, AND THE RESULTS WOULD GET PUT INTO A DIFFERENT SYSTEM, CALLED ALCHEMIST, AND WE WOULD TAKE THE DATA FROM THERE AND INSERT IT INTO A SPREADSHEET. AND THAT WAS KIND OF THE FLOW AND THE PROCESS. EACH OF THE TEAMS HAD A DIFFERENT KIND OF FLOW AND PROCESS DEPENDING ON THE MACHINE THAT THEY WERE USING.
MR. BOSTIC: SO FOR THE ASSAY GROUP THAT WE'VE BEEN LOOKING AT FOR THESE DEMOS, HOW MANY TEAMS WOULD BE INVOLVED TO RUN THE LIST OF TESTS THAT WE'VE BEEN LOOKING AT?
ERIKA CHEUNG: FOR THE CBC, CHEM 14, AND VITAMIN D, THAT SET?
MR. BOSTIC: CORRECT.
ERIKA CHEUNG: SO THERE ARE THREE TEAMS.
MR. BOSTIC: SO THREE SEPARATE TEAMS OF LAB TECHNICIANS OR LAB STAFF WOULD BE INVOLVED IN RUNNING THIS SINGLE SAMPLE?
ERIKA CHEUNG: YES, AND SOME SCIENTISTS, YEAH.
MR. BOSTIC: AND HOW MANY DIFFERENT TYPES OF DEVICES, OR DIFFERENT TYPES OF ANALYZERS, WOULD BE USED TO PROCESS THIS SINGLE SAMPLE?
ERIKA CHEUNG: IN TERMS OF ANALYZERS, WHAT'S ACTUALLY RUNNING THE SAMPLE, IT WAS THREE.
MR. BOSTIC: AND ONE OF THOSE BEING MANUFACTURED BY THERANOS; CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: WAS THAT WORKFLOW THAT YOU JUST DESCRIBED THE SAME AS THE WORKFLOW THAT WAS USED GENERALLY FOR CLINICAL PATIENT TESTING AT THERANOS?
ERIKA CHEUNG: BY "CLINICAL PATIENT TESTING" DO YOU MEAN VENOUS SAMPLES?
MR. BOSTIC: I MEAN CLINICAL PATIENT TESTING IN THE NORMAL COURSE OF BUSINESS AS OPPOSED TO DEMOS.
ERIKA CHEUNG: YES, IN TERMS OF THE PATIENT PROCESSING AND THE -- IT WAS THE SAME PROCESS THAT WE UTILIZED FOR WALGREENS PATIENTS AT THERANOS.
MR. BOSTIC: YOU DISCUSSED PREVIOUSLY HOW YOU SPENT TIME IN BOTH THE R&D LAB AT THERANOS AND ALSO IN THE CLINICAL LAB; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS YOUR TRANSITION FROM ONE TO THE OTHER A CLEAN BREAK, OR DID YOUR RESPONSIBILITIES OVERLAP DURING THESE PERIODS OF TIME?
ERIKA CHEUNG: THERE WAS SOME OVERLAP OF RESPONSIBILITIES FOR A BIT OF TIME.
MR. BOSTIC: COULD I ASK YOU TO TURN TO EXHIBIT 1557 IN THE BINDER IN FRONT OF YOU. ONCE YOU'RE THERE, LET ME KNOW IF YOU RECOGNIZE 1557.
ERIKA CHEUNG: I DO.
MR. BOSTIC: AND WHAT IS 1557?
ERIKA CHEUNG: 1557 IS ESSENTIALLY MARK PANDORI, WHO IS THE LAB DIRECTOR AT THERANOS IN THERANOS'S CLINICAL LAB, GIVING ME A VERY DETAILED LIST OF WHAT MY KEY ROLE AND RESPONSIBILITIES ARE AND DUTIES ARE. SO IT'S JUST CREATING A MORE FORMALIZED STRUCTURE AROUND WHAT I WAS RESPONSIBLE FOR WHILE WORKING IN THE CLINICAL LAB.
MR. BOSTIC: AND IF YOU TURN TO PAGE 2 OF THAT EXHIBIT. TAKE A LOOK AT IT. MY QUESTION IS, DOES THAT ACCURATELY REFLECT YOUR RESPONSIBILITIES AS YOU UNDERSTOOD THEM WHEN YOU WERE AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT INTO EVIDENCE EXHIBIT 1557.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1557 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: LET'S LOOK AT PAGE 2 OF EXHIBIT 1557. THANK YOU, MS. HOLLIMAN. IF WE CAN ZOOM IN ON THE FIVE ITEMS. PERFECT. THANK YOU. MS. CHEUNG, ITEM 2 ON THIS LIST SAYS DAILY PERFORM LABORATORY TESTING AS DIRECTED BY THE SCHEDULE. IS THAT REFERRING TO CLINICAL PATIENT TESTING?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS PERFORMING CLINICAL PATIENT TESTING PART OF YOUR REGULAR DUTIES AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND ITEM 4 SAYS, "AS NEEDED (OR MONTHLY): VERIFY THAT SOP FOR EDISON TESTS ARE ACCURATE FOR HOW THEY ARE CURRENTLY ACTUALLY PERFORMED." DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND CAN YOU EXPLAIN WHAT THAT MEANT AS FAR AS YOUR RESPONSIBILITIES?
ERIKA CHEUNG: SO AT THERANOS THERE WERE SOP'S, WHICH ARE STANDARD OPERATING PROCEDURES, AND ESSENTIALLY THEY WILL TELL PEOPLE LIKE ME WHO ARE LAB ASSOCIATES OR THE CLINICAL LAB SCIENTISTS WHAT ARE THE STEPS AND THE PROCEDURES THAT YOU HAVE TO FOLLOW IN ORDER TO CONDUCT A TEST. AND WE HAD STANDARD OPERATING PROCEDURES FOR EACH OF THE TESTS. SO VITAMIN D HAD ITS OWN STANDARD OPERATING PROCEDURE. AND SOMETIMES THESE STANDARD OPERATING PROCEDURES WERE GENERATED BY THE RESEARCH AND DEVELOPMENT LAB, BUT THE CONVERSION OVER TO THE CLINICAL LAB, THERE WAS SOMETIMES NOT ACCURATE INFORMATION IN TERMS OF HOW WE WERE RUNNING IT ON A DAY-TO-DAY BASIS BECAUSE THERE STILL WAS NOT THAT TRANSFER OF WHAT OUR WORD OF MOUTH PRACTICES WERE VERSUS WHAT WAS DICTATED IN THAT ACTUAL STANDARD OPERATING PROCEDURE. SO THAT'S ESSENTIALLY WHAT THIS RESPONSIBILITY WAS IS WHEN I -- MARK WAS TRYING TO GET ME TO MAKE SURE THAT I RECORRECTED THE STANDARD OPERATING PROCEDURES BASED ON WHAT WE HAD DONE AND BASED ON WHAT OTHER SCIENTISTS IN THE RESEARCH AND DEVELOPMENT LAB HAD TOLD ME, YOU KNOW, HEY, WE NEED TO CORRECT THIS, OR THE MEDICAL DIRECTOR TOLD ME THAT THIS IS NOT ACTUALLY APPROPRIATE. SO THAT WAS THE KIND OF KEY DUTY THAT WAS LISTED HERE.
MR. BOSTIC: ITEM 5 ON THE LIST SAYS "CONTINUOUS: ASSIST IN ANY ONGOING VALIDATIONS, CALIBRATIONS OR REQUEST OPERATIONS, AS NECESSARY." WE TALKED ABOUT WHAT VALIDATION MEANT BEFORE; CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: AND WAS THAT AN ACTIVITY THAT OCCURRED IN THE RESEARCH AND DEVELOPMENT LAB?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND SO IN OTHER WORDS, ALTHOUGH YOU WERE GOING TO BE WORKING IN THE CLINICAL LAB, YOUR DUTIES WOULD STILL INCLUDE SOME VALIDATION OR R&D WORK?
ERIKA CHEUNG: YES.
MR. BOSTIC: WE ALSO TALKED PREVIOUSLY ABOUT QC. SO WHAT DOES QC STAND FOR?
ERIKA CHEUNG: SO QC STANDS FOR QUALITY CONTROL.
MR. BOSTIC: AT A HIGH LEVEL, CAN YOU EXPLAIN WHAT THAT MEANT AT THERANOS AND REMIND THE JURY HOW THAT WAS CONDUCTED.
ERIKA CHEUNG: YEAH. SO QUALITY CONTROL OPERATIONS ARE ESSENTIALLY A CHECK TO SEE IF YOUR DIAGNOSTIC SYSTEM IS WORKING PROPERLY. SO WHAT YOU TYPICALLY WILL DO IS THAT YOU'LL HAVE THESE SAMPLES WHERE YOU KNOW THE CONCENTRATION AT DIFFERENT LEVELS. SO THERE WILL BE A LOW LEVEL, MAYBE A MIDDLE LEVEL, AND A HIGH LEVEL. AND YOU'RE SUPPOSED TO RUN THEM BEFORE YOU RUN A PATIENT SAMPLE TO CHECK THAT EVERYTHING IS WORKING APPROPRIATELY. SO BASICALLY IF I HAVE A LOW LEVEL QC SAMPLE, I NEED TO MAKE SURE THAT IT'S 5 MICROGRAMS FOR MIL FOR SOMETHING LIKE VITAMIN D, AND I'LL RUN IT IN MY SYSTEM AND I EITHER PASS OR FAIL FOR THAT. AND SO I GET SOMETHING RELATIVELY IN THE RANGE OF 5 MICROGRAMS FOR MIL, OR I DON'T. AND THIS IS A VERY STANDARD PROCEDURE FOR ANY TYPE OF DIAGNOSTIC USUALLY JUST TO MAKE SURE THAT THE WHOLE SYSTEM, THE MEDICAL DIAGNOSTIC SYSTEM IS WORKING APPROPRIATELY SO YOU CAN EFFECTIVELY OR, LIKE, SAFELY PROCEED WITH PROCESSING A PATIENT SAMPLE.
MR. BOSTIC: AND WHAT HAPPENED WHEN A DEVICE FAILED QC, IN OTHER WORDS, WHEN IT DIDN'T RETURN THE CORRECT ANSWER FOR THE TEST SAMPLE?
ERIKA CHEUNG: IF WE FAILED QC, TYPICALLY WE WOULD HAVE TO CONDUCT SOME SORT OF INVESTIGATION OF WHY THE QC FAILED. SO WE WOULD HAVE TO SAY, YOU KNOW, WAS IT MACHINE ERROR? WAS IT MAYBE A TRAINING ERROR OR SOMETHING? AND WE WOULD EITHER HAVE TO IDENTIFY WHAT THE ISSUE WAS AND THEN PROCEED TO RUN QC'S AGAIN, OR WE WOULD HAVE TO USE DIFFERENT SETS OF MACHINES OR RECALIBRATE THE SYSTEM TO MAKE SURE THAT IT WAS CALIBRATED APPROPRIATELY FOR WHATEVER TEST WE HAPPENED TO BE RUNNING.
MR. BOSTIC: DID THERANOS ANALYZERS THAT YOU WORKED WITH FREQUENTLY FAIL QC DURING YOUR TIME AT THE COMPANY?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHEN YOU WERE LAST ON THE STAND WE DISCUSSED AN EXAMPLE OF AN INCIDENT WHERE THAT HAPPENED. DO YOU RECALL THAT?
ERIKA CHEUNG: YES. THE THANKSGIVING EXAMPLE.
MR. BOSTIC: THERE WAS ALSO SOME DISCUSSION DURING THAT TIME OF HOW THERANOS TREATED OUTLIERS IN THE DATA SET. DO YOU RECALL THAT DISCUSSION?
ERIKA CHEUNG: YES.
MR. BOSTIC: CAN YOU EXPLAIN WHERE THOSE OUTLIERS CAME FROM? HOW WAS IT THAT THERE WERE MULTIPLE RESULTS IN THE THERANOS DATA SET?
ERIKA CHEUNG: SO ESSENTIALLY IN ORDER TO GENERATE A PATIENT RESULT, THERANOS HAD SIX DIFFERENT DATA POINTS THAT WERE GENERATED FOR EACH OF TESTS THAT WERE RUN. SO, FOR EXAMPLE, YOU HAVE ONE PATIENT. IT NEEDS A VITAMIN D SAMPLE. SO WHAT WE WOULD DO IS THAT WE WOULD HAVE CARTRIDGES THAT WOULD HAVE TWO REACTION TIPS IN IT, AND YOU WOULD RUN THREE OF THESE CARTRIDGES ON THREE DIFFERENT DEVICES IN ORDER TO GENERATE A POOL OF SIX RESULTS. SO THE OUTLIER DELETION HAPPENED FOR TWO OF THESE SIX GENERATED DATA POINTS.
MR. BOSTIC: AND WHEN YOU SAY "OUTLIER DELETION," WHAT DOES THAT MEAN IN PLAIN LANGUAGE?
ERIKA CHEUNG: OUTLIER DELETION? SO TYPICALLY OR WHAT IT WAS DEFINED AT THERANOS?
MR. BOSTIC: HOW WAS IT DEFINED AT THERANOS? HOW DID IT WORK IN PRACTICE?
ERIKA CHEUNG: SO OUTLIER DELETION IS SOMETHING THAT YOU DO IN THE EVENT THAT THERE'S SOME SORT OF REALLY OUTLANDISH DATA POINT. SO, SAY, IF I'M A TECHNICIAN AND I TRIP AND FALL AND IT PRODUCES SOME SORT OF VERY BIZARRE RESULT, LIKE A ZERO, OR IT'S SO HIGH THAT THE SYSTEM CANNOT DETECT IT, YOU TYPICALLY WILL DELETE THAT. BUT AT THERANOS WHAT WAS HAPPENING IS IT WAS BASICALLY ANY TWO DATA POINTS THAT WOULD BASICALLY NOT HIT THE METRICS THAT WE NEEDED. SO FOR THE QC, FOR EXAMPLE, YOU WOULD DELETE TWO OF THE DATA POINTS THAT WOULD BASICALLY THEN ALLOW YOU TO PASS QC'S. SO IT -- THERE WAS NO STANDARD PROTOCOL AT THERANOS FOR WHAT OUTLIER DELETION WAS. IT WAS SOMETHING THAT WAS CONDUCTED QUITE FREQUENTLY, AND IN NORMAL SENSE THIS WOULD BE CONSIDERED CHERRY PICKING, WHERE YOU'RE ESSENTIALLY PICKING THE BEST DATA POINTS TO MAKE IT APPEAR THAT THE QUALITY OF THE DATA IS BETTER THAN IT IS.
MR. BOSTIC: AND WHAT HAPPENS TO THE DATA POINTS, THE RESULTS THAT ARE DEEMED OUTLIERS? ARE THEY REPORTED TO THE PATIENT, FOR EXAMPLE?
ERIKA CHEUNG: NO.
MR. BOSTIC: DID THE INFORMATION REPORTED TO THE PATIENT, IF YOU KNOW, INCLUDE ANYTHING ABOUT THIS PRACTICE OF OUTLIER DELETION?
ERIKA CHEUNG: NO.
MR. BOSTIC: AND TO BE CLEAR ABOUT WHAT WE'RE TALKING ABOUT, THESE DIFFERENT DATA POINTS, IS IT CORRECT THAT EVERY TIME AN ASSAY WAS RUN ON A THERANOS ANALYZER FOR A PATIENT TEST, IT WAS RUN SIX TIMES TO GENERATE THOSE SIX DIFFERENT RESULTS?
ERIKA CHEUNG: IT WAS RUN -- CAN YOU REPEAT THAT QUESTION?
MR. BOSTIC: SURE. THE QUESTION IS, HOW DO WE ARRIVE AT SIX RESULTS? IS IT THAT THE TEST IS ACTUALLY BEING PERFORMED SIX TIMES IN PARALLEL?
ERIKA CHEUNG: SO IT'S BEING RUN SIX TIMES IN PARALLEL, BUT EACH OF THE TESTING CARTRIDGES HAVE TWO REACTIONS IN IT. SO THE SAME SAMPLE IS BEING RUN SIX TIMES, BUT ON THREE DIFFERENT MACHINES.
MR. BOSTIC: SO EACH TEST IS YIELDING SIX RESULTS BECAUSE OF THE THREE TIMES TWO THAT YOU JUST MENTIONED?
ERIKA CHEUNG: YES. YES.
MR. BOSTIC: I'LL ASK YOU TO LOOK AT EXHIBIT 1323 IN YOUR BINDER. LET ME KNOW IF YOU RECOGNIZE THAT DOCUMENT ONCE YOU GET THERE.
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS EXHIBIT 1323?
ERIKA CHEUNG: LET ME MAKE SURE. YEAH. EXHIBIT 12 -- WHAT IS IT?
MR. BOSTIC: 1323.
ERIKA CHEUNG: 1323 IS AN EMAIL BETWEEN ME AND ONE OF THE LEAD SCIENTISTS, TWO OF THE LEAD SCIENTISTS AT THERANOS.
MR. BOSTIC: AND DOES THE EMAIL CHAIN BEGIN WITH AN EMAIL FROM YOU TO TWO OTHER EMPLOYEES AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND GENERALLY SPEAKING, WHAT IS THE SUBJECT MATTER OF THE EMAIL?
ERIKA CHEUNG: SO THE SUBJECT MATTER OF THIS EMAIL IS I'M TRYING TO CONSULT TWO PEOPLE IN THE RESEARCH AND DEVELOPMENT LAB ABOUT, YOU KNOW, BASICALLY SAYING THERE'S NO PATIENT SAMPLE TONIGHT, BUT I RAN THE QC'S AND THEY'RE NOT PASSING.
MR. BOSTIC: WAS EMAIL A PRIMARY WAY THAT YOU RECORDED AND CONVEYED INFORMATION TO OTHERS AT THERANOS ABOUT INSTANCES LIKE THESE WHERE QC'S FAILED FOR A THERANOS DEVICE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS THAT PART OF THE STANDARD PRACTICE OF OPERATION IN THE LAB?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND SPECIFICALLY WAS THE USE OF EMAIL TO CONVEY INFORMATION LIKE THIS PART OF THE STANDARD PRACTICE IN THE COURSE OF THERANOS'S BUSINESS PRACTICES?
ERIKA CHEUNG: YES.
MR. BOSTIC: WAS IT IMPORTANT TO CONVEY INFORMATION LIKE THIS ABOUT INDIVIDUAL QC FAILURES ACCURATELY TO OTHERS AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: SO WAS IT IMPORTANT THAT EMAILS LIKE THIS BE ACCURATE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS IT STANDARD PRACTICE AT THERANOS IN THE LAB TO PROVIDE THIS EMAIL NOTIFICATION CONTEMPORANEOUSLY, IN OTHER WORDS, AT THE TIME THAT THE QC FAILURE WAS OCCURRING?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1323.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED. IT MAY BE PUBLISHED. THANK YOU.
(GOVERNMENT'S EXHIBIT 1323 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S PROJECT THAT ON THE SCREEN, MS. HOLLIMAN. LET'S ZOOM IN ON THE BOTTOM MESSAGE.
MR. BOSTIC: MS. CHEUNG, IS THIS THE EMAIL THAT WE'VE BEEN DISCUSSING?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DOES THIS REFERENCE ANOTHER QUALITY CONTROL FAILURE AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND CAN YOU TELL WHETHER THIS WAS IN RESEARCH AND DEVELOPMENT OR THE CLINICAL LAB AT THERANOS?
ERIKA CHEUNG: THIS WAS IN THE RESEARCH AND DEVELOPMENT LAB AT THERANOS.
MR. BOSTIC: AND IN YOUR EMAIL YOU MENTION A BIAS CORRECTION. WHAT IS A BIAS CORRECTION?
ERIKA CHEUNG: THE BIAS CORRECTION WAS ESSENTIALLY AN ORDER TO -- WE WOULD GET A MEAN OF ALL OF THE AGGREGATIVE RESULTS AND THEN RUN IT THROUGH A BIAS CORRECTION, SORT OF A CALIBRATION CURVE IN ORDER TO GET THE FINAL RESULT, AND THERE WERE DIFFERENT WAYS THAT THAT WAS CREATED. THERE WAS -- WHAT WE DID IN RESEARCH AND DEVELOPMENT AND SARAH SIVARAMAN HAD HER OWN -- HAD HER OWN PROCEDURES OF WHAT THEY CREATED IN THE CLINICAL LAB.
MR. BOSTIC: YOUR EMAIL SAYS, "I RECEIVED THE NEW RANGE FROM SARAH WITH THE BIAS CORRECTION, BUT THE QC'S ARE STILL FAILING." DOES THAT MEAN THAT THIS QC FAILURE WAS AN ONGOING OR PREEXISTING PROBLEM AT THE THERANOS LAB?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THE BIAS CORRECTION, WAS IT DESIGNED IN SOME WAY TO HOPEFULLY FIX THE QC FAILURE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DO YOU REMEMBER WHETHER THE BIAS CORRECTION ACTUALLY SUCCEEDED IN FIXING THE QC FAILURE PROBLEM?
ERIKA CHEUNG: NO.
MR. BOSTIC: SORRY. I ASKED A BAD QUESTION. IF YOU RECALL --
ERIKA CHEUNG: YEAH.
MR. BOSTIC: -- DID THE BIAS CORRECTION FIX THE QC FAILURE PROBLEM AT THERANOS?
ERIKA CHEUNG: IT DID NOT FIX THE QC FAILURE PROBLEM.
MR. BOSTIC: YOU SAID THIS WAS IN THE RESEARCH AND DEVELOPMENT LAB. DID PROBLEMS LIKE THESE IN THE RESEARCH AND DEVELOPMENT LAB CAUSE ANY CONCERNS FOR YOU IN TERMS OF THE ACTIVITIES IN THE CLINICAL LAB WHERE PATIENT TESTING WAS HANDLED?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHY IS THAT?
ERIKA CHEUNG: IT CAUSED CONCERNS BECAUSE QC'S ARE REALLY AN INDICATION OF HOW YOUR TESTING SYSTEM WOULD OPERATE IF YOU WERE RUNNING ACTUAL PATIENT SAMPLES. SO IF YOU'RE HAVING AN IMMENSE AMOUNT OF FAILURES IN THE QC SYSTEM WHERE YOU KNOW THE CONCENTRATION, YOU KNOW WHAT THE SAMPLE IS, YOU KNOW WHAT THE RIGHT ANSWER IS, IF THEY'RE FAILING CONSTANTLY, THAT MEANS WHEN YOU'RE GOING AND TRYING TO BE THE AUTHORITY ON GIVING A PATIENT WHAT THEIR TEST RESULT IS, IT DOESN'T GIVE YOU THE CONFIDENCE THAT IT'S VERY RELIABLE. SO IT WAS VERY CONCERNING IN A RESEARCH CONTEXT BECAUSE ONCE THAT TRANSLATES TO A PATIENT SETTING, YOU KNOW, THAT'S -- IT'S GIVING YOU A GOOD INDICATION THAT THE SYSTEM ISN'T WORKING RELIABLY ENOUGH TO FEEL CONFIDENT AND COMFORTABLE IN RUNNING A PATIENT SAMPLE. SO IT WAS CONCERNING FOR ME.
MR. BOSTIC: AND WAS THIS A CONCERN THAT YOU HAD AT THE TIME OR ONLY IN RETROSPECT?
ERIKA CHEUNG: IT WAS A CONCERN THAT I HAD AT THE TIME.
MR. BOSTIC: WE SPOKE ABOUT RESTRICTION OF INFORMATION DURING YOUR TIME AT THERANOS. WHAT WAS YOUR SENSE OF HOW FREELY INFORMATION FLOWED BETWEEN RESEARCH AND DEVELOPMENT AND THE CLINICAL LAB, SINCE YOU WORKED IN BOTH?
ERIKA CHEUNG: IT -- I WAS IN A PARTICULAR POSITION WHERE I UNDERSTOOD THE INFORMATION BETWEEN BOTH, BUT THERE WAS A LOT OF RESTRICTIONS IN THE INFORMATION WHERE WE HAD TWO DIFFERENT DRIVES AND WHERE WE COULD SHARE INFORMATION THAT ONLY CERTAIN PEOPLE HAD ACCESS TO. AS I WAS WORKING FOR THE COMPANY, IT GOT MORE AND MORE RESTRICTIVE WHERE THERE WASN'T SUPPOSED TO BE MUCH CROSS-COMMUNICATION WITH THE CLINICAL LAB AND OTHER TEAMS, BUT THERE WASN'T -- YOU HAD TO MAKE A VERY CONCERTED EFFORT TO WALK UP AND TALK TO PEOPLE IN ORDER TO GET THE INFORMATION THAT YOU NEEDED AMONGST DIFFERENT DEPARTMENTS.
MR. BOSTIC: AND IF YOU HAVE AN UNDERSTANDING OF THIS, WAS THAT JUST BECAUSE OF THE WAY THE BUILDING WAS LAID OUT OR THE WAY THAT INFORMATION WAS STORED, OR DID YOU GET THE SENSE THAT THAT WAS A DELIBERATE THING? FOR EXAMPLE, DID YOU GET ANY INSTRUCTIONS ABOUT HOW INFORMATION WAS TO BE SHARED BETWEEN GROUPS?
ERIKA CHEUNG: I FELT IT WAS A DELIBERATE THING, BECAUSE EVEN IN THE WAY IN WHICH THE BUILDING WAS CONSTRUCTED, WE ONLY HAD CARD KEY ACCESS TO CERTAIN AREAS AND CERTAIN PEOPLE WERE ONLY ALLOWED IN CERTAIN PARTS OF THE BUILDING DESPITE -- YOU KNOW, I WORKED IN THE CLINICAL LAB, BUT ONLY CERTAIN PEOPLE IN THE CLINICAL LAB WOULD HAVE ACCESS TO THE RESEARCH AND DEVELOPMENT LAB WHERE PATIENT PROCESSING WAS ACTUALLY HAPPENING. SO, YEAH, THAT WAS --
MR. BOSTIC: YOU SAID LATER IN YOUR TIME AT THE COMPANY THAT YOU PERCEIVED SOME ADDITIONAL RESTRICTIONS ON INFORMATION SHARING BETWEEN EMPLOYEES. WHAT FORM DID THAT TAKE?
ERIKA CHEUNG: ESPECIALLY WHILE WORKING IN THE CLINICAL LAB, WE WERE DIRECTED THAT WE SHOULDN'T BE TALKING ABOUT THE ONGOINGS OF WHAT WAS HAPPENING IN THE CLINICAL LAB WITH EMPLOYEES IN OTHER DEPARTMENTS; THAT IT WAS MEANT TO BE HELD AND KEPT WITHIN CLIA AND THAT WE SHOULDN'T BE SHARING INFORMATION WITH OTHER EMPLOYEES WITHIN THE ORGANIZATION ABOUT WHAT THE PROCEEDINGS OF THE CLINICAL LAB WERE, DESPITE THE FACT THAT OUR WORK IN THE CLINICAL LAB WAS HEAVILY RELIANT AND DEPENDENT ON WHAT WAS OCCURRING IN THE RESEARCH AND DEVELOPMENT LAB.
MR. BOSTIC: DID THAT INFORMATION THAT YOU UNDERSTOOD YOU WEREN'T SUPPOSED TO SHARE INCLUDE INFORMATION ABOUT PROBLEMS THAT WERE BEING ENCOUNTERED IN THE CLINICAL LAB?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHO GAVE YOU THE INSTRUCTIONS NOT TO SHARE INFORMATION LIKE THAT?
ERIKA CHEUNG: SUNNY BALWANI.
MR. BOSTIC: AND WHAT FORM DID THOSE INSTRUCTIONS TAKE?
ERIKA CHEUNG: EMAIL.
MR. BOSTIC: THE INCIDENTS THAT WE'VE LOOKED AT SO FAR WHERE QC FAILED, WERE THOSE ISOLATED INCIDENTS AT THERANOS? WERE THEY UNIQUE? OR DID THINGS LIKE THAT OCCUR REGULARLY?
ERIKA CHEUNG: THEY OCCURRED REGULARLY.
MR. BOSTIC: WHEN IT CAME TO QUALITY CONTROL FOR THE THERANOS EDISON ANALYZER, WHAT WAS YOUR OVERALL SENSE OF ITS PERFORM IN QC?
ERIKA CHEUNG: IT HAD VERY POOR PERFORMANCE. WE WERE HAVING QC FAILURES AT A MAXIMUM EVERY THREE DAYS, POSSIBLY MORE.
MR. BOSTIC: WE JUST LOOKED AT AN INCIDENT IN DECEMBER OF 2013. AROUND THAT TIME, DECEMBER 2013, JANUARY 2014, DID YOU RAISE THE CONCERNS THAT YOU HAD WITH ANYONE HIGHER UP AT THERANOS?
ERIKA CHEUNG: I HAD RAISED MY CONCERNS WITH A LOT OF THE HEAD -- LEAD SCIENTISTS WITHIN THE RESEARCH AND DEVELOPMENT LAB, IN ADDITION TO THE LAB DIRECTOR AND MEDICAL DIRECTOR AT THERANOS, AND EVEN RAISED CONCERNS TO THE VICE PRESIDENT, DANIEL YOUNG.
MR. BOSTIC: LET'S BREAK THAT DOWN A LITTLE BIT. THE INDIVIDUALS YOU MENTIONED FIRST, THE SENIOR PEOPLE IN THE RESEARCH AND DEVELOPMENT LAB, THE LAB DIRECTOR, WHO ARE THE NAMES OF THOSE INDIVIDUALS?
ERIKA CHEUNG: SO IN TERMS OF WHO IS IN CHARGE OF THE IMMUNOASSAY TEAM, AT THAT TIME THAT IS SHARADA SIVARAMAN; AND THEN AT THE CLINICAL LAB, THE LAB DIRECTOR IS MARK PANDORI, AND ADAM ROSENDORFF, WHO WAS THE MEDICAL DIRECTOR; AND THEN THE VICE PRESIDENT WAS DANIEL YOUNG.
MR. BOSTIC: WHAT DO YOU REMEMBER ABOUT SPECIFICALLY YOUR CONVERSATION WITH DANIEL YOUNG ABOUT THESE ISSUES?
ERIKA CHEUNG: ONE OF THE --
MR. WADE: YOUR HONOR, IF I COULD JUST OBJECT ON HEARSAY GROUNDS DEPENDING ON THE NATURE OF THE ANSWER. THE QUESTION MAY HAVE CALLED FOR HEARSAY.
JUDGE DAVILA: THANK YOU. YOU CAN FINISH YOUR QUESTION.
BY MR. BOSTIC:
MR. BOSTIC: THE QUESTION, MS. CHEUNG, WAS, WHAT DO YOU REMEMBER ABOUT WHAT WAS DISCUSSED BETWEEN YOU AND DANIEL YOUNG DURING THAT CONVERSATION?
ERIKA CHEUNG: SO WE HAD A MEETING BETWEEN SHARADA SIVARAMAN AND DANIEL YOUNG AND MYSELF BECAUSE OF THE QC FAILURES HAPPENING SO FREQUENTLY, AND WE WERE TRYING TO SORT OF TROUBLESHOOT WHAT WAS THE NATURE OF THE PROBLEM. SO OFTEN WHAT WAS HAPPENING WAS THAT WE WOULD TRY AND COME UP WITH DIFFERENT REASONING. SO THE QC MATERIAL THAT YOU USE, THE SAMPLES TENDED TO BE PURCHASED BY THIRD PARTIES, AND THERE ARE WAYS IN WHICH YOU CAN CREATE THEM ACTUALLY IN HOUSE. SO IT WAS ALWAYS THE CASE THAT WE WERE COMING UP WITH ANY POSSIBLE EXPLANATION OF WHY THESE FAILURES WERE HAPPENING, AND SO THE DISCUSSION WITH DANIEL YOUNG WAS, OKAY, WELL, GO RUN THIS EXPERIMENT TO TRY AND FIGURE OUT, IS IT THE QC MATERIAL? AND IF WE EITHER DEVELOP SOMETHING IN HOUSE VERSUS BUYING THEM EXTERNAL, MAYBE THAT WILL MAKE THE DIFFERENCE AND MAKE THEM PASS. SO THESE WERE THE DISCUSSIONS THAT I HAD WITH DANIEL YOUNG. AND THEN ALSO JUST SHOWCASING THE DATA OF JUST THE FREQUENCY OF THE QC FAILURES.
MR. BOSTIC: WHO ASKED FOR THAT MEETING? HOW DID IT COME TO OCCUR?
ERIKA CHEUNG: THE -- I HAD WORKED WITH SURAJ, WHO WAS PART OF OUR TEAM, AND I ASKED DANIEL YOUNG TO ALL MEET TO SORT OF BRAINSTORM ABOUT WHAT TO DO ABOUT THESE ISSUES BECAUSE IT CREATED NOT ONLY THE PROBLEMS WITH THE QC FAILING, BUT IT CAUSED A WHOLE WEALTH OR OTHER OPERATIONAL ISSUES WITHIN THERANOS, TOO.
MR. BOSTIC: I UNDERSTOOD FROM YOUR TESTIMONY THAT MANY DIFFERENT POSSIBLE REASONS FOR THE QC FAILURES WERE DISCUSSED.
ERIKA CHEUNG: YES.
MR. BOSTIC: IN THOSE DISCUSSIONS, DID YOU FEEL LIKE THERE WAS A POSSIBLE EXPLANATION THAT WAS IGNORED OR NOT GIVEN ENOUGH ATTENTION?
ERIKA CHEUNG: WELL, I MEAN, I THINK THE MOST OBVIOUS ONE, THE FACT THAT THEY WERE HAPPENING SO FREQUENTLY IS JUST THE TESTING SYSTEM, THE EDISON DEVICES DIDN'T WORK. THEY WEREN'T WORKING ON THE ASSAYS AND IN COMBINATION WITH THE DEVICE, IN COMBINATION WITH THE CARTRIDGES JUST WASN'T ADEQUATE ENOUGH AND WASN'T PERFORMING RELIABLY OR EFFECTIVELY TO THE STANDARDS THAT YOU WOULD TYPICALLY SEE FOR ANY OTHER TYPE OF MEDICAL DIAGNOSTIC, AND THAT WAS KIND OF THE OBVIOUS BUT -- OBVIOUS EXPLANATION OF WHY THE QC'S WERE FAILING.
MR. BOSTIC: DID YOU FEEL LIKE, IN THAT DISCUSSION WITH DANIEL YOUNG, NOT ENOUGH ATTENTION WAS PAID TO THAT POSSIBILITY?
ERIKA CHEUNG: YES.
MR. BOSTIC: I'D DIRECT YOU TO EXHIBIT 1431 IN THE BINDER IN FRONT OF YOU. ONCE YOU'RE THERE, TAKE A LOOK AT IT AND LET ME KNOW IF YOU RECOGNIZE THAT DOCUMENT.
ERIKA CHEUNG: YES.
MR. BOSTIC: WHAT IS EXHIBIT 1431?
ERIKA CHEUNG: EXHIBIT 1431 IS ANOTHER INCIDENT OF THE QC'S FAILING AND WE -- ADAM ROSENDORFF, WHO IS THE MEDICAL DIRECTOR, AND SHARADA SIVARAMAN, WHO WAS THE LEAD FOR THE IMMUNOASSAY TEAM, ARE KIND OF DISCUSSING, WHAT DO WE DO ABOUT THE QUALITY CONTROL FAILURES AND TRYING TO COME TO AN UNDERSTANDING OF HOW SHOULD WE RESOLVE SOME ISSUES IN TERMS OF THE DATA THAT WE WERE OBTAINING FROM THE QUALITY CONTROL FAILURES.
MR. BOSTIC: I'LL DIRECT YOUR ATTENTION TO PAGE 6 OF THE EXHIBIT. DOWN AT THE BOTTOM THERE'S AN EMAIL FROM ADAM ROSENDORFF TO YOU. DO YOU SEE THAT?
ERIKA CHEUNG: PAGE?
MR. BOSTIC: PAGE 6. THEY'RE NUMBERED IN THE CENTER.
ERIKA CHEUNG: OH, OKAY. GOT IT.
MR. BOSTIC: AND DO YOU SEE THE EMAIL FROM ADAM ROSENDORFF TO YOU AT THE BOTTOM OF THE PAGE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IF YOU TURN THE PAGE, YOU'LL SEE THAT THAT EMAIL TO YOU CONTAINS SOME DATA.
ERIKA CHEUNG: TURN THE PAGE TO 5?
MR. BOSTIC: SORRY. FORWARD TO PAGE 7?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS THAT DATA THAT IS INCLUDED IN THAT EMAIL?
ERIKA CHEUNG: SO THE DATA INCLUDED IN THIS EMAIL ARE THE QC RANGES THAT WE HAVE FOR DIFFERENT TESTS. SO WE HAVE TOTAL TESTOSTERONE; WE HAVE HEPATITIS C; AND FREE T4; WE HAVE TSH, WHICH IS ALSO A THYROID TEST; AND THEN TPSA, WHICH IS A PROSTATE CANCER BIOMARKER, AND ESSENTIALLY GIVING THE QC RANGES FOR EACH OF THOSE TESTS.
MR. BOSTIC: AND WAS QC RELATED INFORMATION LIKE THIS GENERALLY TRANSMITTED BY EMAIL DURING YOUR TIME AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS EMAIL THE WAY IN WHICH YOU AND OTHER EMPLOYEES IN THE LAB SHARED AND DOCUMENTED QC DATA LIKE THIS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS IT ALSO THE STANDARD PRACTICE AT THERANOS TO DISCUSS AND CONSULT ABOUT QC DATA OVER EMAIL?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IN EMAILS LIKE THESE, WAS IT IMPORTANT TO BE ACCURATE AND REPORT THAT DATA CORRECTLY?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WERE EMAILS LIKE THESE PRESERVED SO THAT THEY CAN BE REFERENCED BACK IN THE FUTURE?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1431 AT THIS TIME.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED. IT MAY BE PUBLISHED.
MR. BOSTIC: WHAT'S -- MAY I PUBLISH, YOUR HONOR?
JUDGE DAVILA: YES.
(GOVERNMENT'S EXHIBIT 1431 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S PROJECT THIS AND GO TO PAGE 6 IF WE CAN. LET'S ZOOM IN ON THE MIDDLE MESSAGE.
MR. BOSTIC: MS. CHEUNG, DO YOU SEE IN FRONT OF YOU AN EMAIL FROM ADAM ROSENDORFF TO YOU ON JANUARY 15TH, 2014?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND HE'S ASKING YOU ABOUT THE VITAMIN D RANGES; IS THAT CORRECT?
ERIKA CHEUNG: THAT'S CORRECT.
MR. BOSTIC: AND WE CAN EXIT OUT OF THAT PAGE, AND LET'S GO TO PAGE 5 IN THIS SAME EXHIBIT. LET'S ZOOM IN ON THE BOTTOM HALF OF THE PAGE. DO YOU SEE ANOTHER MESSAGE FROM ADAM ROSENDORFF TO YOU IN THAT SAME EMAIL CHAIN?
ERIKA CHEUNG: YES.
MR. BOSTIC: HE SAYS THE CV PERCENTAGE AT 18 -- IS THAT NANOGRAMS PER MILLILITER?
ERIKA CHEUNG: YES.
MR. BOSTIC: IS WAY TOO HIGH. 33 PERCENT. WHAT IS CV?
ERIKA CHEUNG: CV IS THE COEFFICIENT OF VARIANCE.
MR. BOSTIC: AND WHAT DOES THAT MEAN?
ERIKA CHEUNG: SO THE COEFFICIENT OF VARIANCE IS TO ESSENTIALLY TELL YOU HOW MUCH VARIABILITY YOU HAVE AMONGST DATA POINTS THAT ARE THE SAME. SO BECAUSE WE WERE TAKING THESE AVERAGES OF THESE DIFFERENT DATA POINTS IN ORDER TO GET ONE RESULT, IT'S TO KIND OF CHECK AND SEE BASED ON THE AVERAGE HOW MUCH DEVIATION DO YOU HAVE AND HOW MUCH VARIABILITY DO YOU HAVE AMONGST THAT SET OF DATA POINTS.
MR. BOSTIC: AND GENERALLY SPEAKING IS VARIABILITY A GOOD THING IN LAB TESTING OR IS IT SOMETHING TO BE AVOIDED?
ERIKA CHEUNG: IT'S SOMETHING TO BE AVOIDED.
MR. BOSTIC: WHY IS THAT?
ERIKA CHEUNG: BECAUSE YOU DON'T WANT A SITUATION WHERE IF YOU ARE RUNNING PATIENT RESULTS THAT YOU ARE KIND OF MISSING THE MARK ON THE ACCURACY OR NOT GETTING A PRECISE ENOUGH RESULT AMONGST A PATIENT SAMPLE. SO YOU TEND TO WANT TO HAVE HIGH ACCURACY AND HIGH PRECISION IN YOUR PATIENT RESULT TO MAKE SURE THAT YOU'RE KIND OF HITTING THE MARK ON GETTING AN ACCURATE ANSWER OF DIAGNOSTIC THAT YOU WOULD RUN. SO YOU WANT RELATIVELY LOW CV'S BECAUSE IT'S A WAY TO KIND OF SHOWCASE, YOU KNOW, ARE YOU GETTING PRECISE ENOUGH VALUES OVER TIME.
MR. BOSTIC: SO A HIGH CV WOULD INDICATE A HIGH LEVEL OF VARIABILITY?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WOULD THAT CALL INTO QUESTION THE ACCURACY OF INDIVIDUAL TESTS?
ERIKA CHEUNG: YES, AND THE PRECISION OF IT.
MR. BOSTIC: IN OTHER WORDS, WE'RE TALKING ULTIMATELY ABOUT THE RELIABILITY OF THE RESULTS THAT ARE BEING RECORDED BY THESE TESTS; CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND A HIGH CV IS UNDESIRABLE?
ERIKA CHEUNG: YES.
MR. BOSTIC: IN THIS CASE DR. ROSENDORFF SAYS THAT THE CV IS WAY TOO HIGH AND HE SAYS ACCORDING TO OUR VALIDATIONS IT SHOULD BE AROUND 20 PERCENT. WHAT IS YOUR UNDERSTANDING OF WHAT THAT MEANT?
ERIKA CHEUNG: SO THE VALIDATION STUDIES ARE THE EXPERIMENTS THAT WE RUN TO SHOW THAT THEY'RE APPROVED AND OF A HIGH QUALITY STANDARD TO START RUNNING ON PATIENTS. AND FROM OUR EXPERIMENTS IT HAD COME OUT THAT OUR TESTS HAD A 20 PERCENT CV, BUT WHEN WE'RE RUNNING THE QUALITY CONTROL SAMPLES, THE CV IS AT 33 PERCENT. SO ITS MUCH HIGHER THAN WE ANTICIPATED OR WHAT WE HAD ARTICULATED IN OUR VALIDATION EXPERIMENTS. AND THE LLOQ JUST MEANS A LOWER LIMIT OF QUANTIFICATION, SO THAT'S WHERE LOW VALUE OF VITAMIN D.
MR. BOSTIC: AND THIS IS ALL IN CONNECTION WITH THE VITAMIN D TEST AT THERANOS?
ERIKA CHEUNG: YES. OH, LET ME DOUBLE CHECK. YES, I BELIEVE SO.
MR. BOSTIC: AND LET'S GO BACK TO PAGE 6 OF THE EXHIBIT IF WE CAN. ZOOM BACK IN ON THAT EMAIL MESSAGE. DO YOU SEE HERE THAT DR. ROSENDORFF IS MENTIONING VITAMIN D. DOES THAT REFRESH YOUR MEMORY ABOUT WHICH ASSAY WE'RE TALKING ABOUT HERE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND LET'S GO TO PAGE 3, PLEASE. LET'S ZOOM IN ON THE BOTTOM MESSAGE WHERE IT BEGINS "HI ADAM." THIS IS AN EMAIL FROM SHARADA SIVARAMAN; CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: SHE SAYS, "THE CV'S ARE HIGH BETWEEN DEVICES IF YOU SEE FOR THE DATA IN THE DAILY QC THE WITHIN CARTRIDGE CV'S ARE REALLY TIGHT." DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND CAN YOU TELL US WHAT SHE MEANS WHEN SHE SAYS "CV'S BETWEEN DEVICES"?
ERIKA CHEUNG: SO BECAUSE THERANOS USED THREE DIFFERENT DEVICES IN ORDER TO GENERATE ONE PATIENT SAMPLE, THE CARTRIDGES HAVE TWO TESTING REACTIONS IN THEM. SO THE CV'S IN TERMS OF WHAT YOU SEE IN THE CARTRIDGES IS TIGHT BUT NOT NECESSARILY BETWEEN THE DEVICES.
MR. BOSTIC: SO I WANT TO CIRCLE BACK ON SOMETHING YOU SAID. YOU SAID THERANOS USED THREE DEVICES TO GENERATE RESULTS FOR ONE PATIENT SAMPLE; IS THAT CORRECT?
ERIKA CHEUNG: THAT'S CORRECT.
MR. BOSTIC: SO IN ORDER TO RETURN RESULTS FOR A SINGLE PATIENT SAMPLE FOR A SINGLE TEST LIKE VITAMIN D, FOR EXAMPLE, HOW MANY EDISON DEVICES WOULD BE REQUIRED?
ERIKA CHEUNG: THREE EDISON DEVICES.
MR. BOSTIC: ALL RUNNING THE SAME SAMPLE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND ALL CONDUCTING THE SAME TEST FOR VITAMIN D?
ERIKA CHEUNG: YES, FOR THE SAME PATIENT.
MR. BOSTIC: AND WHAT WAS YOUR UNDERSTANDING OF WHY THREE DEVICES WERE USED FOR EACH ASSAY, FOR EACH SAMPLE INSTEAD OF JUST ONE DEVICE?
ERIKA CHEUNG: I DON'T KNOW.
MR. BOSTIC: AT THIS TIME WOULD ONE DEVICE HAVE BEEN ABLE TO GENERATE SIX DIFFERENT RESULTS?
ERIKA CHEUNG: NO.
MR. BOSTIC: WHEN WE LOOKED BEFORE AT THE LIST OF ASSAYS FOR THE DEMO, DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IT INCLUDED THREE ASSAYS THAT WOULD HAVE BEEN RUN ON THE EDISON; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND HOW MANY EDISON DEVICES WOULD HAVE BEEN REQUIRED TO RUN THOSE THREE TESTS ON THAT SINGLE PATIENT SAMPLE?
ERIKA CHEUNG: ON THAT SINGLE? IF IT WAS A VITAMIN D TSH/PSA.
MR. BOSTIC: CORRECT.
ERIKA CHEUNG: SO IT WOULD REQUIRE NINE EDISON DEVICES FOR THAT ONE SAMPLE.
MR. BOSTIC: SO JUST SO I AM CLEAR, THIS VIP COMES IN AND A FINGERSTICK SAMPLE IS DRAWN; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THE FINGERSTICK SAMPLE IS BROUGHT DOWN TO THE LAB WHERE THE TEAMS MEET TO DIVIDE UP THE SAMPLE; IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. BOSTIC: AND THE SAMPLE IS RUN ON MULTIPLE DEVICES?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THAT SAMPLE WOULD NEED TO BE RUN ON NINE INDIVIDUAL EDISON DEVICES IN ORDER TO RETURN RESULTS FOR THOSE THREE EDISON ASSAYS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND EACH OF THE EDISON DEVICES YOU SAID WAS ABOUT THE SIZE OF A COMPUTER TOWER?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THAT DOESN'T INCLUDE THE NON-THERANOS MANUFACTURED DEVICES THAT WOULD BE USED TO RUN THE PANELS; IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. BOSTIC: HOW MANY ADDITIONAL DEVICES WOULD BE REQUIRED TO COMPLETE THAT DEMO BASED ON THE ASSAY LIST THAT WE LOOKED AT?
ERIKA CHEUNG: YOU WOULD NEED -- FOR THE WHOLE TOTAL, SO YOU WOULD NEED THE SIEMENS ADVIA, YOU WOULD NEED THE CYTOMETER, YOU WOULD NEED PROBABLY AT LEAST TWO DIFFERENT TECANS, AND THEN NINE EDISON DEVICES.
MR. BOSTIC: SO TWO OF THOSE THIRD PARTY DEVICES WERE ANALYZERS; CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: IN ADDITION TO THE NINE EDISON ANALYZERS?
ERIKA CHEUNG: YES.
MR. BOSTIC: SO DOES THAT MEAN A TOTAL OF 11 BLOOD ANALYZERS WOULD BE REQUIRED TO RUN THAT SINGLE PATIENT SAMPLE?
ERIKA CHEUNG: YES.
MR. BOSTIC: GOING BACK TO SHARADA'S EMAIL THAT IS ON THE SCREEN. SHE CONTINUES, "SINCE WE ARE ALLOWED TO REMOVE 2 DATA POINTS FROM 6 (1 CARTRIDGE OUT OF 3), I HAVE ATTEMPTED TO DO THAT WITH BOTH THE LEVEL 1 AND 2 DATA AND IT IMPROVES THINGS." IS REMOVING TWO DATA POINTS FROM SIX, IS THAT THE OUTLIER REMOVAL THAT WE HAVE BEEN DISCUSSING?
ERIKA CHEUNG: YES.
MR. BOSTIC: LET'S ZOOM OUT OF THAT AND ZOOM TO THE TOP OF THE NEXT PAGE, PLEASE. DO YOU SEE AN EMAIL FROM ADAM ROSENDORFF TO SHARADA SIVARAMAN AND YOU?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DR. ROSENDORFF SAYS, "SINCE 3 DEVICES ARE BEING USED AS ONE TESTING SYSTEM, FOR THE PURPOSES OF QC WE MUST CONSIDER THEM AS ONE TESTING SYSTEM/DEVICE. THEREFORE THE WITHIN CARTRIDGE CV IS NOT RELEVANT." HE THEN ASKS AT THE BOTTOM "IN CONSIDERING QC, IF THE CV'S ARE VERY HIGH OR THE RANGES OVERLAP, WHICH 2 DATA POINTS SHOULD WE REMOVE FROM THE DATA SET FOR QC GOING FORWARD? IS THERE A PROTOCOL FOR THIS?" WHAT WAS HE ASKING THERE IF YOU UNDERSTAND?
ERIKA CHEUNG: HE WAS ASKING IF THERE WAS A PROCEDURE OR AN OPERATING PLAN IN ORDER TO GIVE SOME CLARITY ON WHEN SHOULD WE DELETE THESE OUTLIERS OR NOT AND TRYING TO FIGURE OUT IF THERE WAS SOME CLEAR CONSENSUS ABOUT WHAT THAT PROCESS LOOKED LIKE.
MR. BOSTIC: LET'S LOOK AT PAGE 1 OF THIS EXHIBIT. LET'S ZOOM IN ON THAT SECTION OF THE DOCUMENT. GREAT. THANK YOU. DO YOU SEE AN EMAIL FROM SHARADA SIVARAMAN IN RESPONSE TO DR. ROSENDORFF AND YOU?
ERIKA CHEUNG: YES.
MR. BOSTIC: CAN YOU PLEASE READ FOR THE RECORD THE SECOND PARAGRAPH OR THE FIRST SENTENCE OF THE SECOND PARAGRAPH.
ERIKA CHEUNG: "AT THIS TIME"?
MR. BOSTIC: UH-HUH.
ERIKA CHEUNG: "AT THIS TIME OUR OUTLIER REMOVAL PROCEDURE IS MANUAL (WE CAN REMOVE 2 OUT OF THE 6 DATA POINTS) AND IT ALSO DEPENDS ON THE DATA SET. SEE EXAMPLE BELOW FROM THE ORIGINAL DATA SET THAT ERIKA SENT OUT."
MR. BOSTIC: THAT'S GOOD. THANK YOU. DURING YOUR TIME AT THERANOS, DID YOU HAVE EXPERIENCE OBSERVING THIS PROCESS OF REMOVING OUTLIERS FROM DATA SETS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT DOES IT MEAN WHEN SHARADA SAYS, "AT THIS TIME OUR OUTLIER REMOVAL PROCEDURE IS MANUAL"?
ERIKA CHEUNG: THAT MEANS IT'S LEFT UP TO THE INDIVIDUAL WHO IS MANAGING THE DATA TO DETERMINE WHAT THE OUTLIERS ARE.
MR. BOSTIC: AND IF YOU HAD THE CHANCE TO OBSERVE THAT PROCESS IN ACTION, WHAT DID IT LOOK LIKE? WHAT WERE THE STEPS? WHAT WERE THE RULES?
ERIKA CHEUNG: THERE WEREN'T -- THE PROBLEM WITH THE OUTLIER PROCEDURE WERE THAT THERE WERE NO RULES, THERE WERE NO BEST PRACTICES, THERE WERE NO RULES, THERE WAS NOT PROTOCOL, IT WAS REALLY LEFT TO WHOEVER HAPPENED TO BE OBSERVING THE DATA, AND THAT COULD BE SOMEONE WHO IS A SCIENTIST, THAT COULD BE SOMEONE WHO IS AN ENTRY LAB ASSOCIATE. IT WASN'T VERY CLEAR WHAT THEY WOULD DO. AND FREQUENTLY WHAT YOU WOULD SEE HAPPEN IS THAT THE OUTLIER REMOVAL PROCESS WOULD BE IMPLEMENTED WHEN SOMETHING WAS GOING WRONG. SO, FOR EXAMPLE, IN THE VALIDATION EXPERIMENTS, IF IT WAS THE CASE THAT WE WERE NOT HITTING THE APPROPRIATE ACCURACY THAT WE WANTED, THEN IT WAS, WELL, LIKE LET'S GO AND COMB THROUGH ALL OF THE DATA TO SEE IF WE CAN START REMOVING OUTLIERS TO MAKE IT APPEAR THAT THE ACCURACY IS BETTER THAN IT IS. OR IN THE CONTEXT OF THE QUALITY CONTROL DATA, LET'S SEE IF WE CAN COMB THROUGH THE QUALITY CONTROL DATA AND MANIPULATE THE NUMBERS TO FIGURE OUT DOES THIS REMOVE THE OUTLIERS IN ORDER TO SEE IF IT HAS THE QUALITY CONTROLS PASS, BECAUSE THEY WERE FAILING SO OFTEN. SO THERE WASN'T A CLEAR PROTOCOL OR PROCEDURE OR RULES. IT WAS JUST SOMETHING THAT WAS KIND OF STATED YOU CAN REMOVE TWO OUT OF THE SIX DATA POINTS, BUT THERE WASN'T GOOD CLARITY ON WHAT THAT PROCESS ACTUALLY WAS.
MR. BOSTIC: WAS THERE -- IN YOUR EXPERIENCE, WAS THERE NOT EVEN A DEFINITION ABOUT WHAT AN OUTLIER WAS?
ERIKA CHEUNG: THERE WASN'T EVEN A DEFINITION ABOUT WHAT AN OUTLIER WAS, NO.
MR. BOSTIC: WHO WOULD DECIDE, IN YOUR EXPERIENCE, WHAT CONSTITUTED AN OUTLIER FOR A CERTAIN SET OF DATA?
ERIKA CHEUNG: TYPICALLY WHOEVER WAS WORKING WITH THE DATA SET. SO IT WOULD BE SOMEONE LIKE SHARADA SIVARAMAN, WHO WAS IN CHARGE OF R&D, BUT THERE WAS NO POINT PERSON REALLY TO DETERMINE WHAT AN OUTLIER WAS VERSUS WHAT WASN'T.
MR. BOSTIC: SO AS YOU UNDERSTOOD IT, THE PROCESS ALLOWED WHOEVER WAS MAKING THIS DECISION TO CHOOSE ANY DATA POINTS THAT THEY WANTED, ANY TWO DATA POINTS TO IGNORE?
ERIKA CHEUNG: YES.
MR. BOSTIC: I'LL ASK YOU TO -- WE CAN TAKE THAT DOWN. THANK YOU, MS. HOLLIMAN. I'LL ASK YOU TO LOOK AT EXHIBIT 1512 IN YOUR BINDER, PLEASE.
ERIKA CHEUNG: OKAY.
MR. BOSTIC: DO YOU RECOGNIZE THE DOCUMENT AT EXHIBIT 1512?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND GENERALLY SPEAKING, WHAT IS IT?
ERIKA CHEUNG: THIS DOCUMENT IS -- THIS EMAIL IS IN REGARDS TO A PATIENT SAMPLE THAT CAME IN FOR HEPATITIS C.
MR. BOSTIC: AND WHAT WAS THE PURPOSE OF THESE EMAIL COMMUNICATIONS IN CONNECTION WITH THAT SAMPLE?
ERIKA CHEUNG: SO THE PURPOSE OF THIS EMAIL COMMUNICATION WAS THAT WE RECEIVED A PATIENT SAMPLE FOR HEPATITIS C, BUT WE WERE NOT QUITE PREPARED IN THE CLINICAL LAB FOR THE EDISON DEVICES TO RUN THAT, AND WE WERE TRYING TO SORT OUT WHAT TO DO ABOUT IT BECAUSE I DIDN'T FEEL COMFORTABLE RUNNING A HEPATITIS C IN THE CURRENT INFRASTRUCTURE THAT WE HAD. SO I WAS ADVISING ADAM ROSENDORFF, WHO WAS THE MEDICAL DIRECTOR, MARK PANDORI, AND SURAJ SAKSENA EFFECTIVELY ABOUT MY CONCERNS REGARDING THIS PARTICULAR PATIENT SAMPLE REGARDING HEPATITIS C.
MR. BOSTIC: AND WERE EMAILS LIKE THESE STANDARD MECHANISMS FOR COMMUNICATING ABOUT THESE KINDS OF ISSUES IN THE THERANOS LAB?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS IT PART OF YOUR STANDARD PRACTICE TO SEND EMAILS LIKE THESE TO COORDINATE OR NAVIGATE ISSUES CONCERNING THE TESTING OF CERTAIN PATIENT SAMPLES?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS IT IMPORTANT TO BE ACCURATE IN EMAILS LIKE THESE ABOUT THE DETAILS AND WHAT WAS HAPPENING?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DID EMAILS LIKE THESE -- WAS IT YOUR PRACTICE TO SEND THEM AROUND THE TIME THAT THE EVENTS WERE ACTUALLY OCCURRING?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DOES THIS PARTICULAR EMAIL RELATE TO EVENTS THAT WERE OCCURRING WHILE YOU WERE SENDING AND RECEIVING THESE EMAILS?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT INTO EVIDENCE EXHIBIT 1512.
MR. WADE: YOUR HONOR, THE PREVIOUS OBJECTIONS, PLUS THERE'S A BILL OF PARTICULARS WITH RESPECT TO HEPATITIS C.
JUDGE DAVILA: ALL RIGHT. THANK YOU. THIS MAY BE ADMITTED. I'LL OVERRULE THE OBJECTION. THIS MAY BE ADMITTED PER THE COURT'S PREVIOUS RULING, AND IT MAY BE PUBLISHED.
MR. BOSTIC: THANK YOU.
(GOVERNMENT'S EXHIBIT 1512 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S PROJECT, MS. HOLLIMAN, PAGE 1 OF THIS EXHIBIT. LET'S MOVE IN OR LET'S ZOOM IN ON THE THIRD EMAIL DOWN, PLEASE. THE ONE JUST ABOVE THAT.
MR. BOSTIC: THIS EMAIL ON ITS FACE APPEARS TO COME FROM SOMEONE NAMED ROMINA RIENER. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DO YOU KNOW WHO SENT THIS EMAIL?
ERIKA CHEUNG: I SENT THIS EMAIL.
MR. BOSTIC: CAN YOU EXPLAIN HOW IT CAME TO BE THAT IT COMES FROM HER EMAIL ADDRESS?
ERIKA CHEUNG: WITHIN THE LAB WE HAD ALL OF OUR COMPUTERS SET UP ON THE LAB BENCHES, AND I ACCIDENTALLY SENT THIS EMAIL THROUGH ROMINA'S COMPUTER BECAUSE ALL OF THE COMPUTERS LOOK THE SAME.
MR. BOSTIC: LET ME ASK A GENERAL QUESTION, WHICH IS DURING YOUR TIME AT THERANOS, WERE THERE TIMES WHEN YOU WERE UNCOMFORTABLE RUNNING PATIENT SAMPLES BECAUSE OF THE CONCERNS THAT WE'VE DISCUSSED?
ERIKA CHEUNG: YES.
MR. BOSTIC: IN THIS CASE -- SORRY, LET'S ZOOM OUT AND ZOOM IN ON THE TOP MESSAGE ON THIS PAGE. DO YOU SEE AN EMAIL FROM YOU TO DR. ROSENDORFF; CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: CAN YOU EXPLAIN WHAT YOU'RE CONVEYING IN THIS EMAIL, PLEASE.
ERIKA CHEUNG: EFFECTIVELY, BECAUSE I HAD BROUGHT UP TO MARK AND SURAJ THAT I WAS UNCOMFORTABLE RUNNING THE HEPATITIS C SAMPLE, WE HAD BRAIN STORMED A DIFFERENT SOLUTION WHERE ESSENTIALLY WE UTILIZED AN FDA APPROVED WAIVED TEST CALLED THE ORAQUICK WHERE YOU CAN RUN A HEPATITIS C SAMPLE UTILIZING FINGERSTICK BLOOD, AND THESE ORAQUICK TESTS CAN BE PURCHASED OFF THE SHELF. AND WE HAPPENED TO HAVE SOME OF THEM, AND SO WE RAN THE HEPATITIS C SAMPLE FOR THIS PATIENT UTILIZING THE ORAQUICK HEPATITIS C TEST.
MR. BOSTIC: SO TO BE PERFECTLY CLEAR, THE ORAQUICK TEST THAT YOU'RE DISCUSSING --
ERIKA CHEUNG: YES.
MR. BOSTIC: -- WAS THAT MANUFACTURED OR DEVELOPED BY THERANOS AT ALL?
ERIKA CHEUNG: NO.
MR. BOSTIC: AND WAS IT COMMERCIALLY AVAILABLE?
ERIKA CHEUNG: YES.
MR. BOSTIC: WAS IT MODIFIED BY THERANOS IN ANY WAY?
ERIKA CHEUNG: NO.
MR. BOSTIC: BEFORE THE DECISION WAS MADE TO USE ORAQUICK, WHAT ANALYZER WAS GOING TO BE USED TO RUN THIS ASSAY?
ERIKA CHEUNG: THE EDISON DEVICES.
MR. BOSTIC: FOLLOWING THIS EVENT, DO YOU KNOW WHETHER THERANOS CONTINUED TO USE THE ORAQUICK DEVICE FOR THIS ASSAY OR WENT BACK TO THE EDISON?
ERIKA CHEUNG: WE CONTINUED TO UTILIZE THE ORAQUICK WAIVED TEST. WE HAD PURCHASED MORE.
MR. BOSTIC: SO, IN OTHER WORDS, WHEN A PATIENT CAME TO THERANOS FOR THIS PARTICULAR ASSAY, THAT TEST WOULD NOT BE RUN ON A THERANOS MANUFACTURED OR MODIFIED DEVICE AT ALL; CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: YOUR HONOR, THIS IS A GOOD STOPPING POINT IF THE COURT WOULD LIKE TO TAKE A BREAK AT 10:45.
JUDGE DAVILA: THANK YOU. LADIES AND GENTLEMEN, WE'LL TAKE A BREAK NOW FOR ABOUT 30 MINUTES. SO I'LL REMIND YOU OF THE ADMONITION THAT IS IN PLACE. PLEASE DO NOT DISCUSS THIS CASE WITH ANYONE. DO NOT DO ANY RESEARCH. MS. KRATZMANN WILL COLLECT UP IN ABOUT 30 MINUTES. AND I'LL HAVE A DIFFERENT SCHEDULE ABOUT OUR BREAKS FOR THE REST OF THE AFTERNOON. ALL RIGHT. THANK YOU. WE'LL BE IN RECESS. YOU CAN STAND DOWN, MS. CHEUNG.
COURT CLERK: COURT IS IN RECESS.
(RECESS FROM 10:44 A.M. UNTIL 11:20 A.M.)
JUDGE DAVILA: THANK YOU. PLEASE BE SEATED. WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. THE WITNESS IS ON THE STAND. OUR JURY AND ALTERNATES ARE PRESENT. THANK YOU VERY MUCH. WHAT I THOUGHT I WOULD DO -- BEFORE YOU BEGIN, PARDON ME, WHAT I THOUGHT WE WOULD DO IS -- OH, THAT. WHAT I THOUGHT WE WOULD DO, LADIES AND GENTLEMEN, IF THIS IS CONVENIENT FOR YOU, LADIES AND GENTLEMEN OF THE JURY, I THOUGHT WE WOULD BREAK ABOUT 12:45, TAKE ABOUT A 45 MINUTE BREAK FOR YOU, AND THEN COME BACK AT ABOUT 1:30, AND THEN GO UNTIL 3:00. SOMETHING LIKE THAT. THAT'S THE SCHEDULE THAT I'D LIKE TO ENGAGE. I HOPE THAT IS CONVENIENT FOR OUR JURY. I SEE NODS OF HEADS. SO WE'LL AIM TO DO THAT. THANK YOU. YOU CAN CONTINUE WITH YOUR EXAMINATION.
MR. BOSTIC: THANK YOU, YOUR HONOR.
MR. BOSTIC: WELCOME BACK, MS. CHEUNG. ARE YOU FAMILIAR WITH A TERM PT FROM YOUR TIME AT THERANOS?
ERIKA CHEUNG: YES. PT STANDS FOR PROFICIENCY TESTING.
MR. BOSTIC: AND WHAT IS PROFICIENCY TESTING GENERALLY SPEAKING?
ERIKA CHEUNG: PROFICIENCY TESTING IS A TYPE OF THIRD PARTY TEST THAT YOU HAVE TO RUN IN ORDER TO MAINTAIN YOUR CERTIFICATION TO KEEP RUNNING SAMPLES. SO TYPICALLY AS A REQUIREMENT OF YOUR CLIA CERTIFICATION YOU'LL HAVE TO RECEIVE SAMPLES FROM A THIRD PARTY ORGANIZATION OR A THIRD PARTY LAB WHO WILL SEND YOU A PATIENT SAMPLE THAT YOU'RE SUPPOSED TO RUN THROUGH YOUR NORMAL WORKFLOW, AND YOU GIVE THEM THE RESULTS AND THEY TELL YOU WHETHER YOU PASSED OR FAILED AND WHETHER YOU CAN MAINTAIN YOUR LICENSE OR THE PASSING OF THE PROFICIENCY TESTING.
MR. BOSTIC: AND IS THE PROFICIENCY TESTING THAT YOU'RE TALKING ABOUT ANOTHER MEANS LIKE QC OF CONFIRMING THAT THE TESTS ARE RETURNING ACCURATE AND CONSISTENT RESULTS?
ERIKA CHEUNG: YES.
MR. BOSTIC: I'LL ASK YOU TO TURN IN YOUR BINDER, PLEASE, TO EXHIBIT 1548. ONCE YOU GET THERE, TAKE A LOOK AND LET ME KNOW IF YOU RECOGNIZE EXHIBIT 1548?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS THAT DOCUMENT?
ERIKA CHEUNG: SO THIS DOCUMENT IS AN EMAIL THAT -- INITIALLY IT'S AN EMAIL THREAD THAT I RECEIVED FROM LANGLY GEE WHO WAS THE QUALITY CONTROL MANAGER AT THERANOS, AND I HAD SENT A DOCUMENT OF OUR PROFICIENCY TESTING RESULTS THAT WE HAD DONE BOTH ON THE EDISON DEVICES AND IN ADDITION TO THE SORT OF THIRD PARTY MACHINE DEVICES AND SENT IT TO TYLER SHULTZ, WHO WAS ANOTHER EMPLOYEE WHO WORKED FOR THE ORGANIZATION.
MR. BOSTIC: SO YOU REFERENCED PROFICIENCY TESTING AND SPECIFIC RESULTS. IN THIS CASE HOW DID THE PROFICIENCY TESTING COME TO OCCUR AT THERANOS?
ERIKA CHEUNG: SO THE PROFICIENCY TESTING CAME TO OCCUR AT THERANOS BECAUSE A LABORATORY, AND IN THIS CASE THERE WERE MANY DIFFERENT LABORATORIES, BUT LET'S JUST SAY NEW YORK WOULD ESSENTIALLY NOTIFY US THAT WE WERE GOING TO HAVE TO DO PROFICIENCY TESTING. THEY WOULD SEND US A BATCH OF SAMPLES. THEY WOULD TELL US WHAT TYPE OF TESTS WE WOULD NEED TO RUN. AND THEN WE WERE SUPPOSED TO RUN IT THROUGH OUR NORMAL WORKFLOW IN ORDER TO GIVE THEM THE RESULTS AND NOTIFY THEM WHAT THEY WERE. AND ONCE WE GENERATED THE RESULTS, THEN WE WOULD SEND THEM OFF OVER TO THEM.
MR. BOSTIC: FOR THIS PARTICULAR ROUND OF PROFICIENCY TESTING, WERE YOU INVOLVED IN ACTUALLY PERFORMING THOSE TESTS AND GENERATING THE DATA?
ERIKA CHEUNG: YES.
MR. BOSTIC: I'LL ASK YOU TO TURN THE PAGE IN EXHIBIT 1548 UNTIL YOU GET TO THE TABLE. IT SHOULD BE ON THE THIRD PAGE. IT'S A TABLE OF DATA?
ERIKA CHEUNG: YES.
MR. BOSTIC: DO YOU RECOGNIZE THIS DATA AS BEING THE PROFICIENCY TESTING DATA THAT YOU HAD A HAND IN GENERATING AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS IT STANDARD PRACTICE AT THERANOS TO SHARE INFORMATION LIKE THIS WITH OTHER LAB PERSONNEL BY EMAIL?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1548.
JUDGE DAVILA: IT'S ADMITTED, AND IT WILL BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1548 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: LET'S LOOK AT THE EMAIL FIRST, MS. HOLLIMAN. MS. CHEUNG, DO YOU SEE EXHIBIT 1548 IN FRONT OF YOU?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND AT THE BOTTOM OF THE SCREEN THERE'S AN EMAIL THAT YOU MENTIONED FROM LANGLY GEE; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND HE SAYS, "SEE ATTACHED SPREADSHEET WITH PROFICIENCY RESULTS UPSTAIRS AND DOWNSTAIRS." BY "PROFICIENCY RESULTS," DO YOU UNDERSTAND THAT TO MEAN THE RESULTS OF THE PROFICIENCY TESTS THAT WE HAVE BEEN TALKING ABOUT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS YOUR UNDERSTANDING OF WHAT HE MEANS BY "UPSTAIRS AND DOWNSTAIRS"?
ERIKA CHEUNG: SO AT THERANOS WE HAD TWO SEPARATE LABORATORIES. WE HAD AN UPSTAIRS LABORATORY WHERE ALL OF THE VENOUS SAMPLES WERE PROCESSED, AND THESE HAD MACHINES FROM THIRD PARTY VENDORS. SO IT HAD UNMODIFIED SIEMENS ADVIA, SIEMENS IMMULITE, AND A WHOLE WEALTH OF DIFFERENT MACHINES IN ORDER TO PROCESS PATIENT SAMPLES WITH VENOUS COLLECTION. AND THEN DOWNSTAIRS WE HAD A LAB CALLED NORMANDY. AND NORMANDY EFFECTIVELY HELD ALL OF THE THERANOS DEVICES, THE EDISONS, OR THE SORT OF THERANOS MODIFIED MACHINES, SO THE SIEMENS ADVIA WITH THE T-CUPS, AND THE BD FORTESSA, AND THE CYTOMETER. AND SO THERE WERE TWO SEPARATE LOCATIONS. THE DOWNSTAIRS LABORATORY ONLY PEOPLE -- THE DOWNSTAIRS LABORATORY, OR NORMANDY, YOU COULD ONLY GET ACCESS IF YOU HAD CARD KEY ACCESS TO IT.
MR. BOSTIC: WAS THAT PORTION OF THE LAB, THE DOWNSTAIRS PORTION THAT INCLUDED THE MODIFIED THIRD PARTY DEVICES, MORE RESTRICTED WHEN IT CAME TO ACCESS THAN THE UPSTAIRS?
ERIKA CHEUNG: THEY WERE MORE RESTRICTED, BUT YES.
MR. BOSTIC: YOU SAID THE DOWNSTAIRS PORTION WAS CALLED NORMANDY. WAS THERE A NAME FOR THE UPSTAIRS PORTION?
ERIKA CHEUNG: IT WAS JUST CALLED CLIA. SOMETIMES IT WOULD BE -- CLIA AND SOMETIMES THE DINOSAUR LAB.
MR. BOSTIC: AND DO YOU HAVE AN IDEA WHY IT WAS CALLED THE DINOSAUR LAB?
ERIKA CHEUNG: IT WAS CALLED THE DINOSAUR LAB BECAUSE IT HAD ALL OF THE TRADITIONAL METHODS OF BLOOD DIAGNOSTICS.
MR. BOSTIC: AND THE THIRD PARTY DEVICES THAT WE WERE TALKING ABOUT BEFORE?
ERIKA CHEUNG: YES.
MR. BOSTIC: DURING YOUR TIME WORKING IN THE CLINICAL LAB, DID YOU HAVE EXPERIENCE WORKING ON THE NORMANDY DEVICES AS WELL AS THE UNMODIFIED THIRD PARTY DEVICES?
ERIKA CHEUNG: YES.
MR. BOSTIC: EARLIER WE LOOKED AT AN EMAIL THAT WAS SENT TO AN EMAIL ADDRESS NORMANDY 911. DO YOU RECALL THAT EMAIL ADDRESS AT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT WAS THE PURPOSE OF THAT EMAIL ADDRESS?
ERIKA CHEUNG: NORMANDY 911 WAS AN EMAIL GROUP WHERE IF THERE WAS ANY PROBLEMS THAT AROSE IN NORMANDY, THIS DOWNSTAIRS LAB, THAT WE WERE SUPPOSED TO SEND AN EMAIL TO IT TO NOTIFY DIFFERENT PEOPLE IN ORDER TO RESOLVE CERTAIN ISSUES SPECIFICALLY REGARDING THE PATIENT SAMPLES. SO IT HAD SOME OF THE LEAD SCIENTISTS AND DIFFERENT UPPER LEVEL MANAGEMENT TO SORT OF RESOLVE ANY ISSUES WE MAY HAVE ENCOUNTERED IN THE EVENT THAT THERE WASN'T STAFF AT THE ACTUAL LOCATION.
MR. BOSTIC: AND DO YOU REMEMBER ONE WAY OR ANOTHER WHETHER THERE WAS A DINOSAUR LAB 911 EMAIL ADDRESS?
ERIKA CHEUNG: NO.
MR. BOSTIC: MS. HOLLIMAN, IF WE COULD LOOK AT -- SORRY. BEFORE WE LEAVE THIS, THE TOP EMAIL MESSAGE IS SENT FROM YOU TO TYLER SHULTZ. WHO WAS TYLER SHULTZ AT THERANOS?
ERIKA CHEUNG: TYLER SHULTZ WAS ANOTHER EMPLOYEE AT THERANOS. HE HAD INITIALLY WORKED WITH ME IN THE RESEARCH AND THE DEVELOPMENT LAB, OR THE IMMUNOASSAY TEAM. HE WAS PULLED IN THERE TEMPORARILY. TYLER I HAD KNOWN THROUGH WORKING THE NIGHT SHIFT RUNNING PATIENT -- RUNNING VALIDATION EXPERIMENTS AND THEN HAD ALSO KNOWN THAT TYLER'S GRANDFATHER WAS ON THE BOARD OF DIRECTORS FOR THERANOS.
MR. BOSTIC: IN THIS EMAIL YOU FORWARD PROFICIENCY TESTING DATA TO TYLER SHULTZ. WHY DID YOU DO THAT AT THIS TIME?
ERIKA CHEUNG: TYLER AND I HAD BEEN TALKING AT LUNCH, AND I HAD TOLD HIM THAT ESSENTIALLY WHAT WAS OCCURRING FOR PROFICIENCY TESTING WAS REALLY CONCERNING, THE FACT THAT WHEN WE WERE TALKING TO THESE THIRD PARTY AUDITORS, WE WERE NOT TELLING THEM THE RESULTS THAT WE WERE GENERATING FOR THE EDISON DEVICES, DESPITE THOSE BEING THE MACHINES THAT WE WERE UTILIZING TO TEST ON PATIENTS, AND WHEN WE HAD DONE A COMPARATIVE STUDY OF THE RESULTS GENERATED ON THE EDISON DEVICES VERSUS THE RESULTS GENERATED FROM THE PREDICATE TRADITIONAL DINOSAUR METHODS OF MACHINES, THERE WAS DISPARITIES BETWEEN THEM AND CONCERNING DISPARITIES. AND SO I HAD TOLD HIM THIS AND WAS BASICALLY FORWARDING THE DATA TO HIM TO ALLOW HIM TO SEE, YOU KNOW, WHAT WAS I TALKING ABOUT IN TERMS OF THESE DISPARITIES THAT WE WERE SEEING IN THE CLINICAL SETTING.
MR. BOSTIC: ARE YOU SAYING THAT THE PROFICIENCY TESTING DATA THAT WE'RE ABOUT TO LOOK AT THAT IS ATTACHED TO THIS EMAIL WAS NOT GENERATED IN THE SAME WAY THAT THERANOS PREVIOUSLY OR OTHERWISE RAN ITS PROFICIENCY TESTING?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: AND WHAT WAS THE DIFFERENCE? TELL ME MORE ABOUT THAT.
ERIKA CHEUNG: THE DIFFERENCE WAS IS FOR THIS PROFICIENCY TESTING THAT WE HAD RUN WE WERE ACTUALLY USING THERANOS'S PROPRIETARY TECHNOLOGY, SO THE EDISON DEVICES. WE WERE NO LONGER JUST GETTING THE PROFICIENCY TESTING RESULTS FROM THE SORT OF FDA APPROVED OFF-THE-SHELF MACHINES ANYMORE. SO THIS WAS DIFFERENT.
MR. BOSTIC: IN YOUR EXPERIENCE AT THE COMPANY, WAS THIS THE FIRST PROFICIENCY TESTING THAT WAS ACTUALLY RUN THE WAY THAT YOU JUST DESCRIBED ON THE THERANOS ANALYZERS?
ERIKA CHEUNG: WERE -- YES.
MR. BOSTIC: MS. HOLLIMAN, LET'S CALL UP THE NATIVE ATTACHMENT TO THIS EMAIL, PLEASE. LET'S -- IF WE CAN ENLARGE THE DATA PORTION A LITTLE BIT SO IT FILLS THE SCREEN. PERFECT. THANK YOU. MS. CHEUNG, DO YOU SEE AN EXCEL CHART IN FRONT OF YOU?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IS THIS THE PROFICIENCY TESTING DATA THAT YOU GENERATED USING THE METHODS THAT WE JUST TALKED ABOUT?
ERIKA CHEUNG: YES.
MR. BOSTIC: IN COLUMN A YOU SEE ITEMS LISTED VITAMIN D, TPSA, FT4, TSH. ARE THOSE DIFFERENT ASSAYS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WE TALKED ABOUT VITAMIN D. WHAT IS THE TPSA ASSAY?
ERIKA CHEUNG: TPSA IS TOTAL PROSTATE SPECIFIC ANTIGEN, AND IT'S USED AS AN INDICATOR OF WHETHER SOMEONE MIGHT BE AT RISK FOR PROSTATE CANCER. FREE T4 IS FREE THYROXINE 4. IT'S THYROID BIOMARKER. SO IT'S UTILIZED TO CHECK THE HEALTH STATUS OF SOMEONE'S THYROID. AND THEN TSH IS A THYROID STIMULATING HORMONE, AND THIS IS ALSO UTILIZED TO CHECK THE HEALTH OF SOMEONE'S THYROID.
MR. BOSTIC: THANK YOU. SO FOR EACH OF THOSE ASSAYS WE SEE THREE ROWS. ONE ROW SAYS PREDICATE, THE NEXT ROW SAYS THERANOS, AND THEN THE THIRD SAYS PERCENT RECOVERY. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT DO EACH OF THOSE SIGNIFY IN THIS TABLE?
ERIKA CHEUNG: SO PREDICATE STANDS FOR THE TRADITIONAL METHODS OR THE DINOSAUR METHODS OR BASICALLY THE OFF-THE-SHELF FDA APPROVED MACHINES THAT YOU CAN PURCHASE COMMERCIALLY. THE THERANOS LINE ROW IS THE RESULTS THAT YOU GET UTILIZING THE EDISON DEVICES. AND THEN THE PERCENT RECOVERY IS ESSENTIALLY THE THERANOS VALUE OVER THE PREDICATE. AND SO, YOU KNOW, THE CLOSER YOU ARE TO 100 PERCENT, THE CLOSER IT IS THAT YOU HAVE A COMPARABLE EXACT ANSWER BETWEEN BASICALLY THE PREDICATE METHOD AND THE THERANOS METHOD.
MR. BOSTIC: SO IN CONDUCTING THIS TESTING, IN YOUR VIEW WHAT WOULD HAVE BEEN -- LET ME START THAT AGAIN. IN CONDUCTING THIS TESTING, WAS THE GOAL OR THE HOPE TO SEE STRONG CORRELATION BETWEEN THE RESULTS BEING RETURNED BY THE THERANOS ANALYZERS COMPARED TO THE THIRD PARTY PREDICATE ANALYZERS?
ERIKA CHEUNG: YES.
MR. BOSTIC: WOULD THAT MEAN THAT PERCENT RECOVERY VALUES OF 100 PERCENT OR CLOSE TO 100 PERCENT WOULD BE FAVORABLE RESULTS?
ERIKA CHEUNG: YES.
MR. BOSTIC: IS THAT GENERALLY WHAT YOU SAW IN THIS DATA? WERE THE RESULTS FAVORABLE IN YOUR VIEW?
ERIKA CHEUNG: NO.
MR. BOSTIC: CAN YOU WALK US THROUGH THAT. HOW CAN WE TELL THAT FROM THIS INFORMATION?
ERIKA CHEUNG: SO IF WE LOOK AT VITAMIN D, VITAMIN D YOU SEE THAT THE THERANOS VALUE IS MUCH HIGHER THAN WHAT THE PREDICATE METHOD IS. SO SOMETIMES YOU SEE THAT THE VITAMIN D LEVEL IS THREE TIMES THE VALUE OF WHAT YOU WOULD GET FOR THE PREDICATE METHOD. THE REASON THIS IS IMPORTANT IS BECAUSE THIS COULD BE TWO VERY DIFFERENT DIAGNOSES OF A PARTICULAR PATIENT. SO, FOR EXAMPLE, FOR NY E09 ON COLUMN F YOU SEE THERE'S 373 PERCENT RECOVERY. SO THIS MEANS THAT THE VALUE IS THREE TIMES HIGHER, MORE THAN THREE TIMES HIGHER THAN YOU SAW IN THE PREDICATE METHOD. SO IF THIS IS A PATIENT, THIS COULD BE THE DIFFERENCE BETWEEN HAVING A DEFICIENCY VERSUS BEING IN THE NORMAL RANGE. I'M NOT SURE WHAT THE CLINICAL RANGES ARE FOR THIS BUT IT'S DIFFERENT DIAGNOSES.
MR. BOSTIC: SO, FOR EXAMPLE, FOR THAT TEST UNDER NY EO9. DO YOU SEE THAT?
ERIKA CHEUNG: YEAH.
MR. BOSTIC: ARE WE LOOKING AT RESULTS FROM THE SAME SAMPLE BEING RUN ON TWO DIFFERENT KINDS OF DEVICES, THE PREDICATE DEVICE AND THEN THE THERANOS DEVICE?
ERIKA CHEUNG: YES.
MR. BOSTIC: IS THAT TRUE FOR EACH OF THESE KIND OF PAIRINGS OF PREDICATE RESULT AND THERANOS RESULT? ARE THESE TESTS BEING DONE ON THE EXACT SAME SAMPLE?
ERIKA CHEUNG: YES.
MR. BOSTIC: WERE THERE ANY OTHER RESULT FOR ANY OF THE OTHER ASSAYS THAT SHOWED YOU THAT THE THERANOS ASSAY WAS NOT PERFORMING CLOSELY IN LINE WITH THE PREDICATE DEVICE?
ERIKA CHEUNG: YES. I THINK THE MOST OBVIOUS IS FOR TPSA, THE TOTAL PROSTATE SPECIFIC ANTIGEN. SO IF YOU LOOK ON COLUMN D AND COLUMN E, WE RERAN THE SAMPLE. SO IF YOU LOOK AT THE PREDICATE METHOD FOR THE FIRST TIME WE RAN IT AND THE SECOND TIME WE RAN IT, YOU GET THE SAME EXACT VALUE. BUT WHEN YOU RUN IT ON THE THERANOS DEVICE, YOU GET TWO DIFFERENT VALUES. AND IT'S ALSO UNDER RECOVERING WHAT THE PREDICATE METHOD WAS. AND IT'S THE SAME THING FOR THE SECOND SET OF RERUNS. WHERE YOU HAVE COLUMN F AND COLUMN G, YOU SEE WHEN WE RUN IT ON THE PREDICATE METHOD IT COMES OUT 7.5, AND 7.5 FOR BOTH OF THE PREDICATE VALUES. BUT THEN WHEN YOU RUN IT ON THE EDISON DEVICES YOU HAVE 4.98 AND THEN YOU HAVE 7.2. SO THAT'S A BIG DIFFERENCE BETWEEN EACH EDISON RUN. AND THEN AT LEAST FOR THAT FIRST RUN THAT WE HAD, THAT'S A PRETTY SIZEABLE DIFFERENCE BETWEEN THE PREDICATE AND THE EDISON VALUES. SO THAT'S REALLY CONCERNING, RIGHT? IT'S CONCERNING THAT YOU CAN BASICALLY RUN THE SAME SAMPLE WITH THE SAME VALUE TWICE IN IT HAS TWO VERY DIFFERENT RESULTS. AND THEN YOU RUN INTO ANOTHER ISSUE OF THE FACT THAT THIS IS WHAT WE ARE SUPPOSED TO REPORT TO REGULATORS. SO NOW WE'RE IN A KIND OF SITUATION OF, WELL, WHAT DO WE GIVE TO REGULATORS IN TELLING THEM IS THE ACCURATE VALUE OF THIS PROFICIENCY TESTING THAT WE'RE SUPPOSED TO GIVE TO THEM?
MR. BOSTIC: PREVIOUSLY YOU TESTIFIED THAT THIS KIND OF INFORMATION HAD NOT BEEN PROVIDED TO REGULATORS?
ERIKA CHEUNG: CAN YOU REPEAT THAT QUESTION.
MR. BOSTIC: DID YOU PREVIOUSLY TESTIFY THAT THIS KIND OF INFORMATION, PROFICIENCY TESTING DONE SPECIFICALLY ON THE THERANOS ANALYZER, HAD NOT BEEN PROVIDED TO THE AUDITORS?
ERIKA CHEUNG: YES.
MR. BOSTIC: I CAN REPHRASE, YOUR HONOR.
JUDGE DAVILA: YOU CAN DO THAT.
MR. BOSTIC: TO YOUR KNOWLEDGE.
JUDGE DAVILA: EXCUSE ME. THE ANSWER IS STRICKEN, AND HE'LL ASK ANOTHER QUESTION.
BY MR. BOSTIC:
MR. BOSTIC: MS. CHEUNG, ARE YOU AWARE DURING YOUR TIME AT THERANOS OF THIS KIND OF INFORMATION BEING SHARED WITH AUDITORS PREVIOUS TO THIS TESTING BEING PERFORMED?
ERIKA CHEUNG: AT MY TIME AT THERANOS WE DID NOT PROVIDE REGULATORS WITH THE RESULTS GENERATED FROM THE THERANOS EDISON DEVICES SIMPLY FROM THE PREDICATE METHOD. SO THIS INFORMATION WAS NOT PROVIDED TO REGULATORS.
MR. BOSTIC: DURING YOUR TIME AT THERANOS WERE YOU INVOLVED IN PROVIDING PROFICIENCY TESTING DATA OR GENERATING PROFICIENCY TESTING DATA TO BE PROVIDED TO REGULATORS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DID THAT INVOLVEMENT GIVE YOU A SENSE OF WHAT DATA WAS BEING GENERATED AND IN TURN WHAT WAS BEING PROVIDED TO AUDITORS OR REGULATORS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IS THAT THE BASIS FOR YOUR PREVIOUS STATEMENT?
ERIKA CHEUNG: YES.
MR. BOSTIC: I WANT TO GO BACK TO THE RERUNS IN THIS CHART. ARE THE RERUNS THE ITEMS THAT APPEAR IN RED IN THE CHART?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND ARE THESE SITUATIONS WHERE THE SAME SAMPLE WAS RUN TWICE IN A ROW, TWICE ON THE PREDICATE DEVICE AND TWICE ON THE EDISON?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND YOU SAID THE RESULTS FOR THOSE RERUNS ON THE PREDICATE DEVICE SHOWED YOU SOMETHING. WHAT WAS THAT? WHAT DO YOU NOTICE ABOUT THOSE RESULTS?
ERIKA CHEUNG: THE RESULTS ON THE PREDICATE DEVICE, WHAT THEY SHOWED ME?
MR. BOSTIC: FOR THE RERUNS.
ERIKA CHEUNG: FOR THE RERUNS? THAT THERE'S CONSISTENCY, RIGHT, THAT YOU OBTAIN THE SAME VALUE BETWEEN THE RUNS.
MR. BOSTIC: IS THAT WHAT YOU WANT TO SEE WHEN YOU'RE DOING A RERUN OF THE SAME SAMPLE, YOU WANT TO SEE THE SAME RESULT COME BACK?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IS THAT HOW THE THERANOS ANALYZER PERFORMED WHEN THOSE SAME TWO SAMPLES WERE RUN TWICE IN A ROW?
ERIKA CHEUNG: NO.
MR. BOSTIC: WERE THERE SIMILAR ISSUES WITH THE CORRELATION BETWEEN THE THERANOS RESULT AND THE PREDICATE RESULT WHEN IT CAME TO THE FT4 TESTING?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND HOW ABOUT FOR TSH, WAS THERE ALSO A SIMILAR MISMATCH BETWEEN THE THERANOS RESULT AND THE PREDICATE RESULT?
ERIKA CHEUNG: YES.
MR. BOSTIC: DO YOU RECALL WHAT THE PREDICATE DEVICE WAS THAT WAS USED FOR THESE TESTS?
ERIKA CHEUNG: YES.
MR. BOSTIC: WHAT WAS IT IF YOU RECALL?
ERIKA CHEUNG: SO FOR VITAMIN D IT WAS THE DIASORIN LIAISON. FOR TPSA, FT4, AND TSH THEY USED THE SIEMENS IMMULITE.
MR. BOSTIC: THOSE DEVICES THAT YOU JUST NAMED ARE THIRD PARTY DEVICES NOT MANUFACTURED BY THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND ARE THOSE DEVICES FDA APPROVED IF YOU KNOW?
ERIKA CHEUNG: YES.
MR. BOSTIC: AFTER THIS DATA WAS GENERATED AT THERANOS, WERE YOU INVOLVED IN DISCUSSIONS ABOUT IT AND ITS SIGNIFICANCE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHO WAS INVOLVED IN THOSE DISCUSSIONS?
ERIKA CHEUNG: MARK PANDORI, WHO WAS THE LAB DIRECTOR; ADAM ROSENDORFF, WHO WAS THE MEDICAL DIRECTOR; AND LANGLY GEE, WHO WAS THE QUALITY CONTROL MANAGER; AND THERE WAS A SMALL TEAM OF US WHO ALL WORKED ON THE EDISON DEVICES WHO WERE ALSO INVOLVED IN THOSE COMMUNICATIONS; AND THEN EVENTUALLY SUNNY BALWANI WAS ALSO INCLUDED IN THOSE DISCUSSIONS OF THE PROFICIENCY TESTING.
MR. BOSTIC: WE CAN TAKE THAT DOWN. THANK YOU, MS. HOLLIMAN. MS. CHEUNG, I'LL ASK YOU TO LOOK AT EXHIBIT 1587 IN YOUR BINDER, PLEASE. ONCE YOU'RE AT 1587, LET ME KNOW IF YOU RECOGNIZE IT, PLEASE.
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS EXHIBIT 1587?
ERIKA CHEUNG: SO EXHIBIT 1587 IS THE ENGINEERING TEAM ESSENTIALLY GIVING US A LIST OF ALL OF THE EDISON DEVICES THAT ARE FAILING QC ON THE HARDWARE ASPECT. AND SO THEY WOULD NOTIFY US OF EDISON READERS THAT WE NEEDED TO AVOID UTILIZING BECAUSE THEY HADN'T QUITE FIXED QC, AND THEY WERE TROUBLING SHOOTING WHAT MAY HAVE BEEN THE ISSUE AND WHETHER TO FIX THEM AND WHATEVER ELSE. SO THAT'S WHAT THIS EMAIL THREAD IS ABOUT.
MR. BOSTIC: THE ORIGINAL EMAIL IN THE CHAIN IS SENT FROM SOMEONE NAMED ALPHONSO NGUYEN. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHO WAS ALPHONSO NGUYEN AT THERANOS?
ERIKA CHEUNG: ALPHONSO NGUYEN WAS LIKE AN ENGINEERING ASSOCIATE, AND HE WORKED FOR SUMARTHA ANEKAL'S TEAM.
MR. BOSTIC: AND WAS HIS ROLE AT THERANOS ONE WHERE HE WOULD HAVE PERSONAL KNOWLEDGE OF WHICH EDISON READERS WERE EXPERIENCING THESE PROBLEMS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS IT STANDARD PRACTICE AT THERANOS FOR HIM AND OTHERS LIKE HIM TO DISTRIBUTE INFORMATION LIKE THIS BY EMAIL?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WAS IT IMPORTANT FOR THE INDIVIDUALS RECEIVING THIS EMAIL TO HAVE ACCESS TO THIS INFORMATION?
ERIKA CHEUNG: YES, IT WAS.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES INTO EVIDENCE EXHIBIT 1587.
MR. WADE: YOUR HONOR, WE OBJECT TO THE EMAIL GOING ONTO THE SECOND PAGE UNDER 805. THE REST IS ACCEPTABLE.
JUDGE DAVILA: BATES 5 -- EXCUSE ME, 353, IS THAT WHAT YOU'RE REFERRING TO?
JUDGE DAVILA: ALL RIGHT. THANK YOU. OVERRULED.
MR. BOSTIC: MAY WE PUBLISH, YOUR HONOR?
JUDGE DAVILA: IT MAY BE PUBLISHED. THANK YOU.
(GOVERNMENT'S EXHIBIT 1587 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, LET'S PROJECT THIS EXHIBIT, PLEASE, 1587, AND LET'S GO TO PAGE 2. LET'S ZOOM IN ON THE BOTTOM MESSAGE, PLEASE.
MR. BOSTIC: MS. CHEUNG, DO YOU SEE THE EMAIL IN FRONT OF YOU THAT WE'VE BEEN DISCUSSING?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IS THIS THE EMAIL THAT LISTS THE BAD 3.0 AND 3.5 READERS FOR THIS TIME PERIOD?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND AGAIN, WHAT DID THIS EMAIL MEAN BY BAD READERS?
ERIKA CHEUNG: ESSENTIALLY THEY DIDN'T PASS QC OR THEY WERE HAVING SOME SORT OF MECHANICAL ISSUE AND -- THERE COULD HAVE BEEN A MULTITUDE OF DIFFERENT PROBLEMS, BUT PROBABLY THEY DIDN'T PASS QC OR SOMETIMES THEY CAN'T READ THE BAR CODES OR THE TRAY GETS STUCK OR YOU'LL HAVE AN INSTANCE WHERE THE REACTION TIPS WON'T EJECT FROM THE MACHINERY INSIDE. SO THAT'S IN REFERENCE TO THE FACT THAT THERE'S PROBABLY SOME TYPE OF ERROR LIKE THAT OCCURRING WITHIN THESE READERS.
MR. BOSTIC: AND WHEN THE EMAIL SAYS 3.0 AND 3.5 READERS. ARE THOSE BOTH REFERRING TO DIFFERENT VERSIONS OF THE THERANOS EDISON?
ERIKA CHEUNG: YES.
MR. BOSTIC: WAS THIS AN UNUSUAL THING FOR THERE TO BE MULTIPLE EDISONS THAT WERE OUT OF COMMISSION DURING A GIVEN WEEK?
ERIKA CHEUNG: NO.
MR. BOSTIC: WAS IT A NORMAL OR A ROUTINE THING FOR THIS TO HAPPEN?
ERIKA CHEUNG: THIS WAS SOMETHING THAT WE ACKNOWLEDGED LIKE ON A WEEKLY BASIS I WOULD SAY.
MR. BOSTIC: LET'S LOOK AT A SIMILAR EXHIBIT, EXHIBIT 1617. MS. CHEUNG, IF YOU COULD TURN TO THAT IN YOUR BINDER. ONCE YOU GET THERE, LET ME KNOW IF YOU RECOGNIZE IT.
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS THIS DOCUMENT?
ERIKA CHEUNG: THIS IS AN EMAIL THAT I'M SENDING OUT TO THE MECHANICAL ENGINEERING TEAM, THE PRODUCTION TEAM LEAD WAS SURAJ SAKSENA AT THIS TIME, AND THEN MARK PANDORI, THE LAB DIRECTOR, ESSENTIALLY TELLING THEM THAT WE WERE HAVING A LOT OF ERRORS GOING ON WITH THE EDISON DEVICES. SO WE WERE ATTEMPTING TO GET ALL OF THE DIFFERENT PEOPLE WHO USED THE EDISON DEVICES TO LIST OUT THE DIFFERENT ERRORS THAT WE WERE ENCOUNTERING WHILE WE WERE WORKING WITH THE EDISON DEVICES AND WHAT TYPE OF ERROR AND ESSENTIALLY CREATED SORT OF AN ERROR DOCUMENTATION SPREADSHEET TO ALLOW ALL OF THESE DIFFERENT TEAMS TO COME TOGETHER AND TO REPORT THE FREQUENCY AND WHAT TYPE OF ERRORS WE WERE HAVING WITH THE EDISON DEVICES.
MR. BOSTIC: AND SIMILAR TO THE OTHER EMAILS WE'VE LOOKED AT, WAS THIS EMAIL SENT TO OTHERS IN THERANOS FOR THE PURPOSE OF SENDING THIS INFORMATION IN THE USUAL COURSE OF BUSINESS?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1617.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1617 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: LET'S DISPLAY THAT EXHIBIT, MS. HOLLIMAN, 1617.
MR. BOSTIC: THIS IS THE EMAIL WE'VE BEEN DISCUSSING, MS. CHEUNG?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND YOU SENT THIS EMAIL ON MARCH 12TH, 2014; CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: AND LET'S LOOK AT THE ATTACHMENT THAT IS LABELLED EDISON 3.5 ERROR DOCUMENTATION. CAN WE OPEN THAT IN NATIVE, MS. HOLLIMAN? IF WE CAN ZOOM IN ON THE TEXT. THANK YOU. MS. CHEUNG, DID YOU CREATE THIS DOCUMENT OR HAVE A HAND IN CREATING IT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHEN WE LOOK UNDER READER ISSUE, CAN YOU DESCRIBE WHAT KIND OF INFORMATION THAT WE'RE SEEING IN THIS TABLE?
ERIKA CHEUNG: SO THE TYPE OF INFORMATION THAT YOU'RE SEEING HERE IS, YOU KNOW, THE READER, THE EDISON DEVICE, THE READER IS SYNONYMOUS TO THE EDISON DEVICE THAT WE'RE HAVING AN ISSUE WITH. THERE WERE DIFFERENT NUMBERS ASSOCIATED WITH EACH EDISON DEVICE. SO THAT'S WHAT THE NUMBER IS FROM. THE TYPE OF ASSAY WE WERE RUNNING, SO WHAT TYPE OF TEST. AND THEN THE TYPE OF ERROR AND WHAT WAS IT ASSOCIATED WITH IT. WAS IT A PATIENT SAMPLE? WAS IT A QUALITY CONTROL? WE WERE ALSO WORKING WITH THE PRODUCTION TEAM THAT WAS TESTING OUT A NEW TYPE OF CARTRIDGE. SO SOME OF THEM WERE IN REFERENCE TO THE PRODUCTION TEAM. AND SO HERE THEY'RE TALKING ABOUT A WIDE VARIETY OF MECHANICAL SOFTWARE OR JUST KIND OF WEIRD ISSUES LIKE THERE WAS A POWER OUTAGE AT ONE POINT THAT OCCURRED WHILE WE WERE RUNNING THE SAMPLES. THIS IS THE DIGITAL COPY. WE HAD SOME OTHER HARD COPIES OF THIS. THIS JUST HAPPENS TO BE THE DIGITAL COPY.
MR. BOSTIC: ERRORS LIKE THESE I THINK YOU CALLED THEM MECHANICAL OR SOFTWARE ERRORS.
ERIKA CHEUNG: YES.
MR. BOSTIC: ARE THESE SEPARATE FROM THE QUALITY CONTROL ERRORS THAT WE'VE BEEN TALKING ABOUT TODAY?
ERIKA CHEUNG: THEY ARE SEPARATE.
MR. BOSTIC: AND WERE THESE KINDS OF ERRORS ALSO A FREQUENT OCCURRENCE WITH THE THERANOS EDISONS' MECHANICAL AND SOFTWARE FAILURES?
ERIKA CHEUNG: YES.
MR. BOSTIC: OKAY. WE CAN TAKE THAT DOWN. THANK YOU, MS. HOLLIMAN. MS. CHEUNG, IF YOU WOULD TURN TO EXHIBIT 1633. LET'S LOOK AT ONE MORE EXHIBIT ABOUT QUALITY CONTROL. WHEN YOU GET THERE LET ME KNOW IF YOU RECOGNIZE IT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS EXHIBIT 1633?
ERIKA CHEUNG: ESSENTIALLY THERE'S ANOTHER QC FAILURE, OR THIS IS TALKING ABOUT THE FAILED QC'S THAT WE WERE EXPERIENCING FOR THE MONTH OF MARCH TO SORT OF GET AN ACCURATE LOOK ABOUT HOW OFTEN WAS IT HAPPENING, WITH WHAT TEST IT WAS HAPPENING, WHAT METHODOLOGIES WAS IT HAPPENING. AND IT WAS A MESSAGE AMONGST ALL OF THE PEOPLE WITHIN THE CLINICAL LAB. SO MARK PANDORI, LAB DIRECTOR, ADAM ROSENDORFF WAS THE MEDICAL DIRECTOR, AND THE TEAM OF US THAT WORKED ON THE EDISON DEVICE SPECIFICALLY.
MR. BOSTIC: WAS IT STANDARD PRACTICE TO CIRCULATE DATA LIKE THIS TO LAB STAFF AT THERANOS IN THE USUAL COURSE OF BUSINESS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THIS EMAIL WAS SENT ON MARCH 28TH AND IT INVOLVES QC DATA FROM THAT MONTH; IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1633.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1633 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: THANK YOU, YOUR HONOR. MS. HOLLIMAN, LET'S PROJECT EXHIBIT 1633, PLEASE. LET'S ZOOM IN ON THE BOTTOM MESSAGE.
MR. BOSTIC: MS. CHEUNG, REMIND US WHO WAS LANGLY GEE AT THERANOS?
ERIKA CHEUNG: LANGLY GEE WAS THE QUALITY CONTROL MANAGER AT THERANOS FOR THE CLINICAL LAB.
MR. BOSTIC: AND IN HIS EMAIL HE SAYS, "MARK." THAT'S MARK PANDORI, I ASSUME; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND "THE OTHER DAY YOU ASKED FOR A NUMBER OF FAILED QC ELISA RUNS." WHAT WAS ELISA AT THERANOS?
ERIKA CHEUNG: SO ELISA WAS THE TYPE OF METHODOLOGY WE USED ON THE EDISON DEVICES. SO QC ELISA RUNS ARE EQUIVALENT TO SAYING THE QC EDISON RUNS.
MR. BOSTIC: SO THIS WOULD BE THE QC PERFORMANCE FOR THE THERANOS EDISON DEVICE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND HIS EMAIL GOES ON TO SAY "FOR MARCH, 26 PERCENT RUNS FAILED." IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND LET'S LOOK AT PAGE 2 OF THIS EXHIBIT, PLEASE. AND THERE'S A TABLE AT THE TOP. LET'S ZOOM IN ON THAT. MS. CHEUNG, IS THIS THE DATA REFLECTING THE QC FAILURES FOR THE EDISON RUNS IN MARCH 2014?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IN THE RIGHT-MOST COLUMN DOES IT PROVIDE THE PERCENT OF QC RUNS THAT FAILED FOR THE ASSAYS INDICATED ON THE LEFT SIDE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND I THINK WE'VE TALKED ABOUT MOST OF THESE ASSAYS IN THE PAST. WHAT WAS THE TST ASSAYS?
ERIKA CHEUNG: TST IS TOTAL TESTOSTERONE.
MR. BOSTIC: AND HOW ABOUT TSH?
ERIKA CHEUNG: TSH IS THYROID STIMULATING HORMONE.
MR. BOSTIC: AND HOW ABOUT TT3?
ERIKA CHEUNG: TT3 IS ANOTHER THYROID BIOMARKER. I'M NOT SURE WHAT THE MIDDLE INITIAL STANDS FOR.
MR. BOSTIC: AND THEN AT THE BOTTOM OF THIS TABLE THERE'S A TOTAL, THE TOTAL NUMBER OF FAILURES AND THE PERCENTAGE OF FAILURES; IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. BOSTIC: AND THE TOTAL PERCENTAGE IS 25.6. WHAT DOES THAT NUMBER MEAN?
ERIKA CHEUNG: SO THAT MEANS FOR EVERY 100 QC TESTS THAT WE PERFORM, 25.6 OF THEM FAIL.
MR. BOSTIC: APPROXIMATELY ONE-QUARTER OF THE QC RUNS FAILED?
ERIKA CHEUNG: YES.
MR. BOSTIC: DURING YOUR TIME AT THERANOS DID YOU HAVE A GENERAL SENSE OF HOW THE EDISON DEVICE PERFORMED ON QC TESTS OVER SEVERAL MONTHS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IS THIS FAILURE RATE UNUSUAL? WAS MARCH AN ESPECIALLY BAD MONTH FOR QC'S AT THERANOS?
ERIKA CHEUNG: NO. THIS WAS PRETTY STANDARD.
MR. BOSTIC: FROM YOUR WORK AT THERANOS DID YOU ALSO COME TO HAVE AN UNDERSTANDING OF HOW THE THIRD PARTY DEVICES PERFORMED, THE UNMODIFIED PREDICATE DEVICES PERFORMED WHEN IT CAME TO QC?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND GENERALLY SPEAKING, HOW DID THIS PERFORMANCE, THE THERANOS ANALYZER PERFORMANCE COMPARE TO THE THIRD PARTY DEVICE PERFORMANCE WHEN IT CAME TO QC?
ERIKA CHEUNG: QC'S RARELY FAILED WITH THE THIRD PARTY DEVICES. IT WAS A VERY UNCOMMON EXPERIENCE TO HAVE QC'S FAIL ON THE PREDICATE DEVICES OR THE FDA APPROVED THIRD PARTY DEVICES.
MR. BOSTIC: SO I THINK WE TALKED ABOUT HOW THE OVERALL FAILURE RATE HERE WAS 25.6 PERCENT. ARE THERE ANY INDIVIDUAL FAILURE RATES FOR SPECIFIC ASSAYS THAT WERE EVEN HIGHER THAN 26 PERCENT?
ERIKA CHEUNG: YES. SO FOR TT3 IT WAS A 51.3 PERCENT FAILURE, AND THEN FOR TOTAL TESTOSTERONE IT WAS 45.2 PERCENT FAILURE.
MR. BOSTIC: AND FOR TT3, WHAT DOES A QC FAILURE RATE OVER 50 PERCENT MEAN PRACTICALLY SPEAKING?
ERIKA CHEUNG: SO IF YOU LOOK AT THIS, WE ONLY DID, YOU KNOW, 39, LET'S SAY, 40 RUNS. SO THAT MEANS 20 OF THOSE FAILED. SO IF YOU FORECAST THAT, BECAUSE A QC SYSTEM IS SUPPOSED TO BE VERY SIMILAR TO HOW YOU WOULD RUN A PATIENT SAMPLE. THAT MEANS FOR EVERY 40 PATIENTS POTENTIALLY THAT WOULD WALK IN THE DOOR, 20 OF THEM WOULD GET RESULTS THAT WERE UNRELIABLE AND THAT POTENTIALLY WERE WRONG, OR THAT WERE WRONG. SO THAT'S A HIGH NUMBER, RIGHT? THAT'S AN EQUIVALENT. YOU WOULD HAVE ABOUT THE SAME LUCK FLIPPING A COIN IN TERMS OF WHETHER YOUR RESULTS WERE RIGHT OR WRONG.
MR. BOSTIC: YOU SAID BEFORE THAT WHEN A DEVICE FAILED QC, THAT IT WASN'T USED DURING THAT SHIFT FOR PATIENT TESTING; IS THAT CORRECT?
ERIKA CHEUNG: CORRECT.
MR. BOSTIC: DID THAT PRACTICE ADDRESS YOUR CONCERNS ABOUT THE QC NUMBERS AT THERANOS?
ERIKA CHEUNG: NO.
MR. BOSTIC: WHY NOT?
ERIKA CHEUNG: BECAUSE OF THE FREQUENCY OF THEM, RIGHT? IT SHOULDN'T BE THE CASE THAT A QUARTER OF THE TIME YOU'RE HAVING THESE QUALITY CONTROL SAMPLES FAILING. THAT'S EXTRAORDINARILY HIGH FOR ANY LAB TEST TO HAPPEN. AND IN ADDITION TO THAT, IT SHOWS THAT THERE'S JUST -- IT'S CONCERNING BECAUSE, AGAIN, WITH THE QUALITY CONTROLS I HAVE THE KNOWN CONCENTRATION, BUT THE MOMENT I GO TO THE PATIENTS, IF I FORECAST OUT WHAT THOSE RESULTS ARE, THAT ONE OUT OF FOUR TIMES I MIGHT GIVE A PATIENT THE WRONG RESULT. AND AT THERANOS, YOU KNOW, AT FIRST WE WERE RUNNING LIKE 10 PATIENTS, BUT IT WOULD BE THE EXPECTATION THAT WE WOULD BE 2,000 PATIENTS A DAY. LIKE, THAT'S A LOT OF PEOPLE TO BASICALLY BE EXPECTING BASED ON THIS INFORMATION THAT A QUARTER OF THEM WOULDN'T GET THE RIGHT RESULTS FOR THEIR HEALTH STATUS. SO IT WAS IMMENSELY CONCERNING TO SEE THIS DEGREE OF FAILURES BECAUSE IT'S JUST NOT TYPICAL FOR A NORMAL LAB. LIKE, IN A NORMAL LAB YOU WOULD WANT TO SEE LESS THAN 1 PERCENT, RIGHT? THESE ARE VERY SMALL -- 1 PERCENT OF FAILURES. IT'S VERY SMALL SAMPLE SIZES, AND WE'RE HAVING THAT PERCENTAGE OF FAILURES, A VERY CONCERNINGLY HIGH PERCENTAGE OF FAILURES.
MR. BOSTIC: WHEN YOU'RE DOING QC TESTING, YOU'RE ABLE TO GET THE RESULT THAT THE MACHINE PUTS OUT AND IMMEDIATELY KNOW WHETHER IT'S THE CORRECT RESULT OR NOT BECAUSE THE CORRECT ANSWER IS NO; IS THAT RIGHT?
ERIKA CHEUNG: EXACTLY.
MR. BOSTIC: IS THAT THE CASE FOR PATIENT TESTING? WHEN YOU RUN A PATIENT SAMPLE, ARE YOU ABLE TO LOOK AT THE RESULT AND EVERY TIME DETERMINE WHETHER IT'S AN ACCURATE RESULT OR NOT?
ERIKA CHEUNG: NO.
MR. BOSTIC: AND SO DOES THAT MEAN YOU NEED THE QC PROCESS TO GIVE YOU A SENSE OF HOW WELL THE DEVICE IS PERFORMING IN ACTUAL PATIENT TESTING?
ERIKA CHEUNG: EXACTLY, YES.
MR. BOSTIC: THIS RESULT IS FROM MARCH OF 2014; CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND HOW MUCH LONGER DID YOU WORK AT THERANOS AFTER THIS?
ERIKA CHEUNG: NOT MUCH LONGER.
MR. BOSTIC: AND YOU CAN TAKE THIS DOWN. THANK YOU, MS. HOLLIMAN. WE'VE DISCUSSED SOME SPECIFIC INCIDENTS THAT YOU ENCOUNTERED AT THERANOS INVOLVING PROBLEMS WITH THE TESTING?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THE INCIDENTS THAT WE'VE DISCUSSED, HAVE THEY BEEN -- HAVE WE TALKED ABOUT ALL OF THE INCIDENTS THAT YOU'VE ENCOUNTERED WHEN YOU WERE AT THERANOS WHEN THERE WERE PROBLEMS WITH THERANOS'S TESTING PERFORMANCE?
ERIKA CHEUNG: NO.
MR. BOSTIC: HAVE THESE BEEN JUST A REPRESENTATIVE SAMPLE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IN MARCH AND APRIL OF 2014, HOW WERE YOU FEELING ABOUT WORKING AT THERANOS? HOW WERE YOU FEELING ABOUT YOUR EMPLOYMENT?
ERIKA CHEUNG: I WAS --
JUDGE DAVILA: OVERRULED. SHE CAN TESTIFY ABOUT IT GENERALLY.
BY MR. BOSTIC:
MR. BOSTIC: MS. CHEUNG, I'M ASKING ABOUT KIND OF WHAT LED TO YOUR DECISION TO LEAVE. SO AROUND THIS TIME PERIOD THE QUESTION WAS HOW WERE YOU FEELING ABOUT WORKING AT THERANOS?
ERIKA CHEUNG: I WAS -- I WAS REALLY STRESSED AND UNCOMFORTABLE WITH WHAT WAS GOING ON BECAUSE I HAD AT THAT POINT AMASSED A LOT OF EVIDENCE TO SUGGEST THAT THE TECHNOLOGY, THE EDISON DEVICE SPECIFICALLY, WERE NOT ADEQUATE TO TEST ON PATIENTS, AND I DID NOT FEEL COMFORTABLE RUNNING PATIENT SAMPLES. AND I HAD TRIED TO NOTIFY PEOPLE ACROSS DIFFERENT DEPARTMENTS WHO HAD MORE DECISION MAKING CAPACITY THAN I DID THAT, LOOK, I'M NOT BEING AN ALARMIST, LIKE, THIS IS THE FREQUENCY AND THE DEGREE IN WHICH WE'RE HAVING ERRORS, AND IT NEEDS TO BE PAID ATTENTION TO BECAUSE WHILE ALL OF THESE ISSUES ARE GOING ON, WE ARE STILL TESTING PATIENT SAMPLES. AND I DON'T FEEL COMFORTABLE WITH THIS BECAUSE THEY DON'T KNOW, THEY DON'T KNOW THE FACT THAT BEHIND CLOSED DOORS WE HAVE ALL OF THESE PROBLEMS, AND THEY THINK THAT THEY'RE GETTING ACCURATE RESULTS, AND THEY'RE MAKING VERY IMPORTANT MEDICAL DECISIONS ABOUT WHAT THEIR TREATMENTS ARE, WHAT THEIR DIAGNOSES ARE, WHAT MEDICATIONS THEY TAKE, AND IT WAS STARTING TO GET VERY, VERY UNCOMFORTABLE AND VERY STRESSFUL FOR ME WORKING AT THE COMPANY. AND I WAS ATTEMPTING TO TELL AS MANY PEOPLE AS I COULD, BUT WAS JUST NOT, JUST NOT SEEMING TO GET THROUGH TO PEOPLE.
MR. BOSTIC: YOU MENTIONED RAISING YOUR CONCERNS TO PEOPLE. DID THAT INCLUDE AT SOME POINT TOWARDS THE END OF YOUR EMPLOYMENT A CONVERSATION WITH SUNNY BALWANI?
ERIKA CHEUNG: YES, IT DID.
MR. BOSTIC: AND HOW DID THAT CONVERSATION COME TO HAPPEN?
ERIKA CHEUNG: SO EFFECTIVELY WHEN I HAD SENT THE PROFICIENCY TESTING RESULTS TO TYLER SHULTZ, SUNNY BALWANI HAD ESSENTIALLY CALLED ME INTO HIS OFFICE TO DISCUSS -- HIS FIRST QUESTION WAS HOW DO I LIKE WORKING AT THERANOS AND HOW IS IT GOING FOR ME? SO WHEN I WALKED INTO HIS OFFICE AND WAS TALKING TO HIM I FIGURED THIS WAS A GOOD OPPORTUNITY TO FINALLY TELL HIM, LIKE, THIS IS THE AMOUNT OF PROBLEMS THAT WE HAVE, THESE ARE THE AREAS THAT WE HAVE PROBLEMS, AND WE NEED TO ADDRESS THESE THINGS BECAUSE THERE WAS SOME HOPE IN THE BACK OF MY MIND THAT MAYBE THERE WAS SOME SORT OF ISSUE WITH COMMUNICATION BETWEEN THE OPERATIONAL FLOOR AND THE EXECUTIVE LEVEL MANAGEMENT. SO I HAD GONE TO HIM, AND I HAD SAID THAT WE HAVE ISSUES WITH OUR QC'S FAILING, WE HAVE ISSUES WITH OUR QUALITY -- THE STABILITY OF THE CHEMICALS THAT WE'RE USING. WE'RE HAVING PROBLEMS WITH VIRTUALLY EVERY ASPECT OF RUNNING THE EDISON DEVICES, AND I'M UNCOMFORTABLE WITH THIS.
AND I LOVE THE MISSION OF THIS COMPANY, AND I UNDERSTAND WHAT WE'RE TRYING TO DO, AND I AGREE WITH THE FACT THAT THIS IS A GOOD MISSION TO BE A PART OF, BUT THIS IS UNACCEPTABLE, RIGHT? THIS IS NOT -- THIS IS NOT WHAT WE SHOULD BE DOING, ESPECIALLY IF WE'RE ALREADY ACTIVELY PROCESSING PATIENTS ALL WHILE THIS IS GOING ON. THE FEEDBACK AND THE RECEPTION THAT I GOT FROM HIM WAS ESSENTIALLY WHAT MAKES YOU THINK YOU'RE QUALIFIED TO MAKE THESE CALLS? YOU'RE A RECENT GRAD OUT OF U.C. BERKELEY. WHAT DO YOU KNOW ABOUT STATISTICS? WHAT DO YOU KNOW ABOUT LAB DIAGNOSTICS? LIKE, YOU HAVE NO VISIBILITY IN THIS COMPANY. THEN HE SAID, YOU KNOW, I NEED TO MAKE A DECISION. ESSENTIALLY, DO I WANT TO WORK HERE? AND IF I WANT TO WORK HERE, I HAVE TO BASICALLY PROCESS PATIENT SAMPLES WITHOUT QUESTION, AND THAT IS MY ONLY ROLE AND RESPONSIBILITY. AND AFTER THAT INCIDENT I LEFT HIS OFFICE.
MR. BOSTIC: WHEN YOU WERE DISCUSSING THE PROBLEMS THAT YOU WERE SEEING WITH MR. BALWANI, WAS IT YOUR SENSE FROM THE CONTENT OF THAT CONVERSATION THAT HE WAS SURPRISED TO BE HEARING ABOUT ANY OF THOSE ISSUES?
ERIKA CHEUNG: NO. IT SEEMED MORE THAT HE WAS IRRITATED THAT I WAS BRINGING UP THESE ISSUES AGAIN, AND THAT HE WAS CONCERNED THAT I WAS RAISING ALARM OR THAT I WASN'T AWARE OF THE FACT THAT THE EDISON DEVICES HAVE BEEN VETTED AND PROVED AND KIND OF DISTRIBUTED IN ALL OF THESE MEANS AND OTHER PEOPLE SAID IT WAS A GREAT DEVICE IN OTHER CONTEXTS. SO IT DIDN'T SEEM IT WAS THE FIRST TIME THAT HE HAD HEARD THIS, AND HE WAS MORE IRRITATED AND ANGRY THAT I WAS BRINGING UP THIS INFORMATION.
MR. BOSTIC: I THINK YOU TESTIFIED THAT YOU LEFT THERANOS IN APRIL OF 2014; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: WAS IT AROUND THE TIME OF THIS MEETING?
ERIKA CHEUNG: YES.
MR. BOSTIC: THE DECISION TO LEAVE THE COMPANY, WAS IT A DECISION THAT YOU TOOK LIGHTLY?
ERIKA CHEUNG: NO.
MR. BOSTIC: AND THE REASONS THAT YOU WERE EXCITED ABOUT JOINING THERANOS, THE MISSION OF THE COMPANY, THE POTENTIAL, DID THOSE FACTORS PLAY A ROLE IN YOUR DECISION WHETHER TO STAY AT THE COMPANY OR NOT?
JUDGE DAVILA: COULD YOU REPHRASE THAT QUESTION. I THINK PER OUR EARLIER CONVERSATION, I THINK YOU CAN ASK THIS IN A DIFFERENT WAY.
BY MR. BOSTIC:
MR. BOSTIC: LET ME ASK YOU SPECIFICALLY, MS. CHEUNG, WHAT WAS YOUR SALARY AT THERANOS?
ERIKA CHEUNG: MY SALARY WAS -- I DON'T --
MR. BOSTIC: IF YOU RECALL APPROXIMATELY?
ERIKA CHEUNG: I THINK I MADE LIKE $19 PER HOUR.
MR. BOSTIC: AND WHEN YOU DECIDED TO LEAVE THE COMPANY, DID YOU HAVE OTHER EMPLOYMENT LINED UP AT THE TIME?
ERIKA CHEUNG: NO.
MR. BOSTIC: THIS WAS YOUR FIRST JOB OUT OF COLLEGE; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOU MENTIONED A CONVERSATION THAT YOU HAD WITH MR. BALWANI. DID YOU THINK ABOUT TAKING YOUR CONCERNS DIRECTLY TO THE CEO OF THE COMPANY, ELIZABETH HOLMES?
ERIKA CHEUNG: I HAD --
JUDGE DAVILA: OVERRULED. YOU CAN ANSWER THE QUESTION.
MR. BOSTIC: WOULD YOU LIKE IT REPEATED?
ERIKA CHEUNG: COULD YOU, PLEASE.
BY MR. BOSTIC:
MR. BOSTIC: THE QUESTION IS YOU TALKED ABOUT A CONVERSATION WITH MR. BALWANI. DID YOU THINK ABOUT RAISING YOUR CONCERNS DIRECTLY WITH MS. HOLMES, THE CEO?
ERIKA CHEUNG: BECAUSE I HAD CLOSE RELATIONSHIPS WITH TYLER SHULTZ, I HAD KNOWN THAT HE HAD WRITTEN AN EMAIL TO ELIZABETH HOLMES ABOUT SOME OF THE CONCERNS AROUND PROFICIENCY TESTING, THE VALIDATION OF THE ASSAYS, THE ISSUES THAT WE WERE HAVING WITH THE QUALITY CONTROLS. SO I JUST FIGURED THAT CONSIDERING THAT TYLER SHULTZ HAD A CLOSER RELATIONSHIP WITH ELIZABETH HOLMES, THAT HE WAS BASICALLY COMMUNICATING WITH HER. SO I DIDN'T CONTACT HER DIRECTLY.
MR. BOSTIC: I'LL ASK YOU TO TURN TO EXHIBIT 1660 IN YOUR BINDER, PLEASE. ONCE YOU'RE THERE, WOULD YOU LET ME KNOW IF YOU RECOGNIZE THAT DOCUMENT.
ERIKA CHEUNG: YES.
MR. BOSTIC: DID TYLER SHULTZ SHOW YOU THIS DOCUMENT WHEN YOU WERE WORKING AT THERANOS OR AROUND THE TIME THAT YOU LEFT?
ERIKA CHEUNG: YES. AFTER MY MEETING WITH SUNNY BALWANI, I IMMEDIATELY CONTACTED TYLER, AND WE WERE GOING TO HAVE DINNER WITH HIS GRANDFATHER, GEORGE SHULTZ, AND BEFORE WE HAD DINNER HE HAD SHOWED ME THIS EMAIL.
MR. BOSTIC: AND EXHIBIT 1660, IS THIS A TRUE AND CORRECT COPY OF THE EMAIL THAT YOU WERE SHOWN BY TYLER SHULTZ TO ELIZABETH HOLMES?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1660.
JUDGE DAVILA: ALL RIGHT. THANK YOU. LADIES AND GENTLEMEN, I'M GOING TO OVERRULE THE OBJECTION AND ADMIT THIS FOR A LIMITED PURPOSE, THOUGH, LADIES AND GENTLEMEN. THIS IS A DOCUMENT -- IS IT JUST BATES STAMPED 7369, COUNSEL?
MR. BOSTIC: IT'S 7369 THROUGH 7374.
JUDGE DAVILA: I SEE. ALL RIGHT. THANK YOU. LADIES AND GENTLEMEN, THIS IS GOING TO BE ADMITTED FOR A LIMITED PURPOSE, AND THAT LIMITED PURPOSE IS ONLY TO SHOW NOTICE, NOTICE AS TO MS. HOLMES. IT'S NOT OFFERED FOR THE TRUTH OF THE MATTER ASSERTED IN THE DOCUMENT ITSELF. THE LIMITED PURPOSE IS TO SHOW NOTICE ONLY, AND FOR THAT LIMITED PURPOSE IT WILL BE ADMITTED.
(GOVERNMENT'S EXHIBIT 1660 WAS ADMITTED.)
MR. BOSTIC: THANK YOU, YOUR HONOR. MAY WE PUBLISH?
JUDGE DAVILA: YES.
MR. BOSTIC: MS. HOLLIMAN, LET'S PROJECT EXHIBIT 1660, PLEASE, THE FIRST PAGE. THANK YOU.
MR. BOSTIC: MS. CHEUNG, ARE YOU LOOKING AT AN IMAGE OF THE EMAIL TYLER SHULTZ SHOWED YOU IN 2014?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THIS IS AN EMAIL TO ELIZABETH HOLMES. DO YOU RECOGNIZE HER EMAIL ADDRESS THERE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IN THIS EMAIL IN THE FIRST PARAGRAPH HE MENTIONS ISSUES REGARDING OR DISCREPANCIES BETWEEN THERANOS CV'S?
ERIKA CHEUNG: UH-HUH.
MR. BOSTIC: AND THE WAY THAT CV'S WERE CALCULATED. IS CV A COEFFICIENT OF VARIATION LIKE WE DISCUSSED EARLIER?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IS THIS RELATED TO THE ISSUE THAT WE DISCUSSED EARLIER WITH THE VARIABILITY IN THERANOS'S TESTS?
ERIKA CHEUNG: YES.
MR. BOSTIC: LOOKING AT PARAGRAPH TWO, MR. SHULTZ SAYS TO MS. HOLMES THAT WHILE HE UNDERSTANDS CALCULATING CV BASED ON THE MEDIANS IS RELEVANT FOR COMPARING OUR SYSTEM TO SYSTEMS OF OUR COMPETITORS, THE FACT THAT THE CV OF OUR CUT-OFF LEVEL FOR SYPHILIS DROPS FROM 43 PERCENT TO 20 PERCENT BY MOVING FROM CV OF THE ENTIRE DATA SET TO CV OF THE MEDIANS TELLS ME THAT A SIGNIFICANT PORTION OF OUR DATA IS JUST NOISE. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: THE QUESTION IS, IS THIS A REFERENCE TO THE PRACTICE OF DELETING OUTLIERS AND TAKING AVERAGES OF MULTIPLE RESULTS THAT WE TALKED ABOUT EARLIER?
ERIKA CHEUNG: YES.
JUDGE DAVILA: OVERRULED. THE ANSWER WILL REMAIN.
BY MR. BOSTIC:
MR. BOSTIC: AND, MS. CHEUNG, YOUR ANSWER WAS?
ERIKA CHEUNG: YES.
MR. BOSTIC: MS. HOLLIMAN, LET'S ZOOM OUT AND ZOOM IN ON THE NEXT FEW PARAGRAPHS, PLEASE. LET'S CAPTURE FROM THERE DOWN TO THE BOTTOM. THAT'S GOOD. THANK YOU. IN THE TOP PARAGRAPH HERE MR. SHULTZ EXPRESSES SOME CONCERNS ABOUT QUALITATIVE ASSAYS. AND THERE'S A REFERENCE ABOUT TWO-THIRDS DOWN THE PARAGRAPH WHERE HE SAYS -- I MIGHT HAVE PUT THAT IN THE WRONG PLACE. BUT HE SAYS THE SECOND PROBLEM THAT I HAVE IS THAT OUR EQUIVOCAL ZONE IS ADJUSTED AND WIDENED UNTIL WE SEE THE SENSITIVITY AND SPECIFICITY THAT WE WANT TO REPORT. AND JUST BEFORE THAT SENTENCE THERE'S A LINE ABOVE IT THAT SAYS WE REPEAT AND DELETE RATHER THAN REPEAT AND ADD. HE'S REFERENCING REPEATING AN EXPERIMENT. DO YOU HAVE KNOWLEDGE ABOUT A PRACTICE AT THERANOS THAT WOULD CORRESPOND TO THIS COMPLAINT?
MR. WADE: YOUR HONOR, IF I COULD JUST OBJECT TO THE FORM OF THE QUESTION AND ALSO JUST HAVE A STANDING OBJECTION ON 602.
JUDGE DAVILA: ALL RIGHT. NOTED. THE COURT'S PREVIOUS ORDER AND RULING WILL REMAIN. YOU CAN ASK THE QUESTION.
BY MR. BOSTIC:
MR. BOSTIC: I'LL TAKE THAT OPPORTUNITY TO REFRAME AND ASK IT MORE DIRECTLY. THE LANGUAGE REFERENCING REPEATING AN EXPERIMENT AND SAYING WE REPEAT AND DELETE RATHER THAN REPEAT AND ADD. ARE YOU AWARE OF A PRACTICE AT THERANOS THAT FITS THAT DESCRIPTION?
ERIKA CHEUNG: YES. SO THIS IS, THIS IS ALSO TALKING ABOUT ALSO THE OUTLIER DILUTION, RIGHT? YOU JUST GET RID OF THE INFORMATION IN THE RUNS THAT AREN'T AMENABLE TO WHAT YOU'RE TRYING TO ACCOMPLISH.
MR. BOSTIC: THE NEXT PARAGRAPH TALKS ABOUT THE ACCURACY OF THERANOS'S TESTS AND IN PARTICULAR WHETHER THE SYPHILIS TEST WAS TRULY THE MOST ACCURATE AND MOST PRECISE SYPHILIS TEST ON THE MARKET. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND HE RELAYS DANIEL YOUNG'S REPORT THAT THERANOS DOES NOT CLAIM TO HAVE THE MOST ACCURATE OR PRECISE TESTS. AND THEN MR. SHULTZ REFERENCES A HANDFUL OF ARTICLES THAT EXPLICITLY MAKES THESE CLAIMS. AROUND THIS TIME WERE YOU SEEING ANY ARTICLES OR PUBLIC MATERIALS ABOUT THERANOS THAT MADE CLAIMS ABOUT THE ACCURACY OF THE TESTS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND BASED ON YOUR EXPERIENCE AT THE COMPANY, WERE THE CLAIMS THAT YOU WERE SEEING ACCURATE?
ERIKA CHEUNG: NO.
MR. BOSTIC: MS. HOLLIMAN, LET'S GO TO THE BOTTOM PARAGRAPH ON THIS PAGE. MR. SHULTZ THEN RAISES A QUESTION OF THE CV OF THE ASSAYS; IS THAT CORRECT?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND IN PARTICULAR HE SAYS OUR CLAIM OF HAVING LESS THAN 10 PERCENT CV FOR OUR ASSAYS. DO YOU REMEMBER SEEING AT THIS TIME CONTENT ON THE THERANOS ASSAY THAT BOASTED ABOUT OR TOUTED A CV OF LESS THAN 10 PERCENT?
ERIKA CHEUNG: YES, IT WAS ON OUR WEBSITE.
MR. BOSTIC: YOU SAID IT WAS ON THE THERANOS WEBSITE?
ERIKA CHEUNG: YES.
MR. BOSTIC: AT THIS TIME BASED ON YOUR EXPERIENCE TESTING THE CV'S, DID THERANOS'S ASSAYS HAVE CV'S OF LESS THAN 10 PERCENT?
ERIKA CHEUNG: NO.
MR. BOSTIC: AND IN PARTICULAR THE VITAMIN D ASSAY, DID IT HAVE AN ESPECIALLY LOW CV OR A CV OF LESS THAN 10 PERCENT?
ERIKA CHEUNG: NO.
MR. BOSTIC: REVIEWING THIS EMAIL, CAN YOU EXPLAIN HOW IT FACTORED INTO YOUR DECISION WHETHER TO ATTEMPT TO SPEAK DIRECTLY WITH MS. HOLMES?
ERIKA CHEUNG: IT -- I FIGURED BECAUSE TYLER HAD A CLOSER RELATIONSHIP WITH ELIZABETH HOLMES AND TO THE BOARD THAT IT WASN'T NECESSARY, ESPECIALLY BECAUSE I HAD MORE CONTACT WITH THE COO OF THE COMPANY, SUNNY BALWANI, AND I HAD ALSO TALKED TO THE BOARD, SO AT THAT POINT I FIGURED IT WASN'T NECESSARY.
MR. BOSTIC: YOU ALSO MENTIONED THAT YOU HAD TALKED TO THE BOARD. WHEN DID YOU HAVE A CHANCE TO SPEAK TO ANY MEMBERS OF THE BOARD?
ERIKA CHEUNG: SO AFTER MY CONVERSATION WITH SUNNY BALWANI, I HAD TALKED TYLER SHULTZ AND TOLD HIM THAT I HAD TALKED TO SUNNY ABOUT MY CONCERNS AND THAT IT WASN'T RECEIVED IN A WAY THAT I THOUGHT THE ISSUES WERE ACTUALLY GOING TO BE ADDRESSED AND RESOLVED. AND HE TOLD ME THAT HE WAS GETTING DINNER WITH HIS GRANDFATHER TO DISCUSS BOTH OF THE ISSUES THAT WE HAD SEEN. AND I SAID CAN I JOIN OR CAN I GO TO DINNER WITH YOU SO I CAN TALK TO YOUR GRANDFATHER ABOUT WHAT WE ARE SEEING IN THE CLINICAL LAB SPECIFICALLY? AND WE WENT TO HIS GRANDFATHER'S HOUSE AND WENT IN THE DOOR. HIS WIFE WAS THERE, CHARLOTTE, AND HIM. AND WE SAT DOWN AND HAD DINNER AND DISCUSSED ESSENTIALLY WHAT WAS HAPPENING IN THE CLINICAL LAB, WHERE THERE WAS THIS EXPECTATION THAT WHEN YOU GOT YOUR BLOOD TESTED AT THERANOS, THAT IT WAS JUST A FINGERSTICK, THAT FINGERSTICK GOES INTO THE CARTRIDGE, IT GOES INTO THE EDISON DEVICES, IT STARTS AND IT RUNS, THAT THAT WASN'T THE REALITY OF THE SITUATION.
WHAT WAS REALLY HAPPENING WAS THAT CARTRIDGE WOULD BE PULLED OUT OF THE EDISON DEVICES WHEN THE DEMO SAMPLES WERE BEING CONDUCTED AND THAT BLOOD SAMPLE, THAT NANOTAINER WOULD BE RUN BASICALLY IN THE BACK LABORATORY NORMANDY WHERE THERE WOULD BE THIS TEAM OF THREE, FOUR DIFFERENT PEOPLE ON STANDBY TO ESSENTIALLY RUN THAT NANOTAINER OR THE BLOOD SAMPLE ON THREE, FOUR DIFFERENT DEVICES, AND SPECIFICALLY WITH THE EDISON DEVICES THERE WERE SO MANY PROBLEMS OCCURRING WITH THE HARDWARE, WITH THE SOFTWARE, WITH THE ASSAYS, WITH THE QUALITY CONTROL, AND NOT ONLY THAT BUT THE TESTS WERE VERY, VERY COMPLICATED AND THEY WERE NOT VERY EXPERIENCED PEOPLE SORT OF RUNNING THEM. SO IT WAS JUST TRYING TO ALERT HIM TO LET HIM KNOW THAT WHAT THEY'RE TELLING YOU IS NOT WHAT IS GOING ON INTERNALLY. AND THAT WAS ESSENTIALLY THE DISCUSSION THAT I HAD WITH GEORGE SHULTZ AT HIS HOUSE AT DINNER.
MR. BOSTIC: AND WAS THAT BEFORE --
MR. WADE: OBJECTION, YOUR HONOR. IF I JUST MIGHT FOR THE RECORD NOTE MY PRIOR OBJECTION AND THE MOTION TO STRIKE THAT.
JUDGE DAVILA: THANK YOU. SO NOTED.
BY MR. BOSTIC:
MR. BOSTIC: MS. CHEUNG, WAS THAT BEFORE OR AFTER YOU LEFT THERANOS?
ERIKA CHEUNG: THIS WAS BEFORE I LEFT THERANOS.
MR. BOSTIC: AND WE CAN TAKE THIS EXHIBIT DOWN. THANK YOU, MS. HOLLIMAN. IN CONNECTION WITH MR. SHULTZ'S GRANDFATHER, WAS THAT GEORGE SHULTZ?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT WAS HIS POSITION AT THERANOS AS YOU UNDERSTAND IT?
ERIKA CHEUNG: GEORGE SHULTZ WAS ONE OF THE BOARD MEMBERS AT THERANOS.
MR. BOSTIC: AND WHEN YOU HAD THIS CONVERSATION -- WELL, LET ME ASK, DO YOU HAVE AN UNDERSTANDING OF WHAT HIS BACKGROUND HAD BEEN BEFORE HE JOINED THE BOARD AT THERANOS?
ERIKA CHEUNG: HE WAS THE EX-SECRETARY OF STATE DURING THE RONALD REAGAN PRESIDENCY.
MR. BOSTIC: AND WHAT WAS HIS APPROXIMATE AGE DURING THE TIME OF THE CONVERSATION THAT WE'VE BEEN DISCUSSING?
ERIKA CHEUNG: I'M NOT TOO SURE, BUT ABOVE 70.
MR. BOSTIC: AND HAS GEORGE SHULTZ SUBSEQUENTLY PASSED AWAY?
ERIKA CHEUNG: YES.
MR. BOSTIC: DID THERE COME A TIME AFTER YOU LEFT THERANOS WHEN YOU RECEIVED A LETTER FROM A LAW FIRM REPRESENTING THE COMPANY?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND I'LL ASK YOU TO LOOK AT EXHIBIT 2567, PLEASE, IN YOUR BINDER. ONCE YOU'RE THERE, LET ME KNOW IF YOU RECOGNIZE THAT DOCUMENT?
ERIKA CHEUNG: I DO.
MR. BOSTIC: AND WHAT IS EXHIBIT 2567?
ERIKA CHEUNG: THIS IS A LETTER THAT I HAD RECEIVED -- I HAD RECEIVED FROM DAVID BOIES SCHILLER, A LAW FIRM REPRESENTING THERANOS. AND ESSENTIALLY THERE WAS SOMEONE IN AN SUV THAT WAS WAITING OUTSIDE OF MY WORKPLACE, AND A COUPLE OF MY COLLEAGUES HAD EFFECTIVELY SAID, "ERIKA, WE DON'T WANT YOU STAYING LATE AT WORK, WE WANT TO WALK YOU TO YOUR CAR, THERE'S BEEN THIS MAN SITTING IN A CAR ALL DAY, AND WE WANT TO MAKE SURE THAT YOU GET HOME SAFELY." SO WHEN I WALKED OUT OF MY EMPLOYER AT THE TIME, THE MAN JUMPED OUT OF THE CAR AND ESSENTIALLY HANDED ME THIS LETTER. AND I OPENED IT AND SAW THAT IT WAS A KIND OF WARNING FROM THERANOS'S LAWYER DAVID BOIES.
MR. BOSTIC: IS EXHIBIT 2567 AND TRUE AND CORRECT COPY OF THE LETTER YOU RECEIVED THAT DAY?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 2567.
JUDGE DAVILA: ALL RIGHT.
JUDGE DAVILA: ALL RIGHT. THANK YOU. I'LL OVERRULE THE OBJECTION, AND THIS CAN BE ADMITTED. THE COURT FINDS THAT THE PROBATIVE VALUE OUTWEIGHS ANY PREJUDICIAL INTEREST, AND IT DOES EXPLAIN THE CONDUCT. IT WILL BE ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 2567 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: THANK YOU, YOUR HONOR. MS. HOLLIMAN, LET'S DISPLAY EXHIBIT 2567, PLEASE. LET'S ZOOM IN ON -- EXACTLY, THE TOP HALF OF THE PAGE.
MR. BOSTIC: MS. CHEUNG, THIS IS THE LETTER THAT YOU RECEIVED ON THAT DAY?
ERIKA CHEUNG: YES.
MR. BOSTIC: BY HAND DELIVERY?
ERIKA CHEUNG: YES.
MR. BOSTIC: THE FIRST PARAGRAPH SAYS IN THE THIRD SENTENCE, "WE ALSO HAVE REASON TO BELIEVE THAT YOU HAVE -- WELL, LET ME START AT THE SECOND SENTENCE. THE SECOND SENTENCE SAYS, "WE HAVE REASON TO BELIEVE THAT YOU HAVE DISCLOSED CERTAIN OF THE COMPANY'S TRADE SECRETS AND OTHER CONFIDENTIAL INFORMATION WITHOUT AUTHORIZATION. WE ALSO HAVE REASON TO BELIEVE THAT YOU HAVE DONE SO IN CONNECTION WITH MAKING FALSE AND DEFAMATORY STATEMENTS ABOUT THE COMPANY FOR THE PURPOSE OF HARMING ITS BUSINESS." DO YOU RECALL AT THIS TIME OR DO YOU HAVE AN UNDERSTANDING OF WHAT ACTIONS THIS LETTER WAS REFERRING TO?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT WAS YOUR UNDERSTANDING?
ERIKA CHEUNG: MY UNDERSTANDING WAS THAT THERE WAS AN INVESTIGATIVE REPORT BEING CONDUCTED BY "THE WALL STREET JOURNAL" AND EFFECTIVELY WHEN I SAW THIS I THOUGHT IT WAS IN REFERENCE TO THAT INVESTIGATIVE REPORT.
MR. BOSTIC: HAD YOU BEEN SPEAKING TO A JOURNALIST FOR "THE WALL STREET JOURNAL" ABOUT THERANOS?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND THE LETTER SAYS, "WE HAVE REASON TO BELIEVE THAT YOU HAVE DONE SO IN CONNECTION WITH MAKING FALSE AND DEFAMATORY STATEMENTS ABOUT THE COMPANY FOR THE PURPOSE OF HARMING ITS BUSINESS." WAS THAT YOUR PURPOSE IN HAVING THESE CONVERSATIONS WITH THE JOURNALIST?
ERIKA CHEUNG: THAT WASN'T MY PURPOSE OR MY INTENTION. I FELT AT THAT MOMENT IN TIME THAT I HAD DONE A LOT TO REPORT INTERNALLY IN THE COMPANY OF THE ISSUES IN REGARDS TO WHAT WAS HAPPENING WITH PATIENT PROCESSING AND HAD TALKED TO EVERYONE I POSSIBLY COULD HAVE. AND WHEN I WAS APPROACHED BY THE JOURNALIST, I FELT HOPEFUL THAT MAYBE PEOPLE COULD ACTUALLY SEE THE TRUTH OF WHAT WAS GOING ON WITH THESE PATIENT SAMPLES BECAUSE I WAS STILL IN DISCUSSION WITH PEOPLE WORKING IN THE COMPANY AND UNDERSTOOD THAT THE EDISONS WERE STILL BEING USED TO PROCESS PATIENT SAMPLES. AND SO FOR ME IT SEEMED KIND OF AS A FINAL RESORT TO GET THE TRUTH OUT ABOUT WHAT WAS HAPPENING WITH ALL OF THESE PATIENT SAMPLES.
MR. BOSTIC: DID YOU UNDERSTAND THAT BY TAKING THOSE STEPS YOU MIGHT FACE LEGAL CONSEQUENCES OR POSSIBLE LITIGATION?
ERIKA CHEUNG: YES.
MR. BOSTIC: DID YOU UNDERSTAND THAT THIS LETTER CONTAINED A THREAT OF LITIGATION AGAINST YOU?
ERIKA CHEUNG: YES.
MR. BOSTIC: YOU SAID I THINK SOMETHING LIKE THIS WAS AN ULTIMATE STEP. BUT AFTER THIS DID YOU, IN FACT, REPORT INFORMATION ABOUT THERANOS TO OTHER INDIVIDUALS?
ERIKA CHEUNG: YES, I DID.
MR. BOSTIC: AND WHO ELSE DID YOU CONTACT TO REPORT ON THERANOS?
ERIKA CHEUNG: I CONTACTED REGULATORS, THE HEALTH REGULATORS THAT ARE IN CHARGE OF PROVIDING THE CERTIFICATION FOR LAB PROCESSING TO ALLOW LABS TO PROCESS PATIENTS.
MR. BOSTIC: AND YOU SAID THAT THE NAME OF THAT ORGANIZATION WAS?
ERIKA CHEUNG: CMS. SO IT'S THE CENTER OF MEDICARE AND MEDICAID SERVICES.
MR. BOSTIC: IS THAT A GOVERNMENTAL REGULATORY AGENCY?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND DO YOU RECALL WHEN IT WAS THAT YOU FIRST CONTACTED CMS ABOUT THERANOS?
ERIKA CHEUNG: I CONTACTED THEM ALMOST IMMEDIATELY, AFTER RECEIVING THIS LETTER FROM DAVID BOIES, BY PHONE. AND THEN I ACTUALLY FILED AN OFFICIAL COMPLAINT PROBABLY A COUPLE MONTHS, MAYBE A LITTLE LONGER, I THINK IN SEPTEMBER.
MR. BOSTIC: AND DID THE INFORMATION THAT YOU PROVIDED CMS GENERALLY ADDRESS THE TOPICS AND CONCERNS THAT WE'VE TALKED ABOUT TODAY AND YESTERDAY?
ERIKA CHEUNG: YES.
MR. BOSTIC: MAY I HAVE A MOMENT, YOUR HONOR?
JUDGE DAVILA: YES, YOUR HONOR.
(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)
BY MR. BOSTIC:
MR. BOSTIC: MS. CHEUNG, ARE YOU CURRENTLY EMPLOYED?
ERIKA CHEUNG: YES.
MR. BOSTIC: AND WHAT IS YOUR CURRENT OCCUPATION?
ERIKA CHEUNG: RIGHT NOW I'M RUNNING MY OWN ORGANIZATION, SO I'M RUNNING A NONPROFIT.
MR. BOSTIC: AND JUST IN GENERAL TERMS, WHAT IS THE ACTIVITY OF THAT NONPROFIT?
JUDGE DAVILA: I'M NOT SURE WHAT THE RELEVANCE OF THIS IS, MR. BOSTIC.
MR. BOSTIC: YOUR HONOR, I'M HAPPY TO APPROACH. MY UNDERSTANDING IS THAT HER CURRENT ROLE IS PARTLY OR IN FULL RESPONSE TO HER EXPERIENCES AT THERANOS.
JUDGE DAVILA: ALL RIGHT. WHY DON'T I SEE THE TWO OF YOU HERE AT SIDE-BAR. LADIES AND GENTLEMEN, YOU CAN STAND AND STRETCH AND DON'T LEAVE THE COURTROOM.
(STRETCHING.)
(SIDE-BAR CONFERENCE ON THE RECORD.)
JUDGE DAVILA: OKAY. WE'RE ON THE RECORD. WE'RE OUTSIDE OF THE PRESENCE OF THE JURY.
COURT CLERK: I'M TRYING TO GIVE YOU MORE LIGHT.
JUDGE DAVILA: WE ARE HERE TO DISCUSS THIS. MR. WADE.
MR. WADE: MAYBE COUNSEL CAN PROFFER EXACTLY WHAT IT IS HE INTENDS TO ELICIT AND THE RELEVANCE OF IT. MY UNDERSTANDING IS THAT PART OF MS. CHEUNG'S STORY, IF YOU WILL, IS THAT SHE FOUNDED AN ETHICS ORGANIZATION OF SOME KIND, AND SHE SUGGESTS THAT THAT'S IN RESPONSE TO THERANOS AND IT'S PART OF HER NEW MISSION. I JUST THINK THAT, YOU KNOW, AS WE'VE NOTED IN THE RECORD SO FAR, MUCH OF THIS EVIDENCE IS FAR BEYOND -- IS TOTALLY IRRELEVANT. IT'S HIGHLY PREJUDICIAL, THINGS THAT HAVE COME IN THUS FAR. WE HAVE NOTED OUR OBJECTIONS, AND WE CONTINUE TO OBJECT ON THOSE ISSUES. BUT THERE'S NO RELEVANCE WHATSOEVER TO A MATERIAL FACT IN THE CASE WITH RESPECT TO HER WORK AT THIS ORGANIZATION. IT'S EXTREMELY PREJUDICIAL UNDER 401 AND 403.
MR. BOSTIC: I THINK TO THE EXTENT HER DECISION TO COMMIT HER CAREER TO THESE ISSUES SPEAKS TO THE IMPACT AND THE SERIOUSNESS OF THE ISSUES THAT SHE OBSERVED AT THERANOS IN HER MIND. I THINK THAT IS RELEVANT. IF THE COURT DECIDES TO KEEP IT OUT OR IT'S NOT RELEVANT, I ASSUME THAT THE DEFENSE WOULD ALSO NOT BE PERMITTED TO GO INTO THAT TOPIC ON CROSS-EXAMINATION.
MR. WADE: WE HAVE NO INTENTION OF GOING INTO THE TOPIC. IT'S HER STATE OF MIND AND HOW IT AFFECTED HER FUTURE LIFE IN THE WORLD IS JUST NOT RELEVANT TO THIS.
JUDGE DAVILA: THANK YOU. MY QUESTION IS THE RELEVANCE OF HER POST EMPLOYMENT STATE OF MIND AND HOW THAT IS RELEVANT TO THE EVENTS THAT SHE'S TESTIFIED TO ALREADY. IF IT IS THAT SHE IS -- SHE CREATED A NONPROFIT REGARDING ETHICS AND BUSINESS I ASSUME IT IS?
MR. BOSTIC: IT IS STARTUPS, I BELIEVE.
JUDGE DAVILA: RIGHT. I'M NOT SURE THAT'S RELEVANT TO THE ISSUES OF YOUR PROSECUTION, WHAT SHE'S DONE AFTERWARDS.
MR. BOSTIC: I WOULD SAY --
JUDGE DAVILA: I'M INCLINED TO SUSTAIN THE OBJECTION, BUT GO AHEAD.
MR. BOSTIC: UNDERSTOOD. I WOULD SAY THAT HER ACTIONS AFTERWARDS SPEAK TO HER STATE OF MIND DURING THE RELEVANT TIME PERIOD, BUT IF NEITHER PARTY GOES INTO THIS, THAT'S FINE. I DON'T THINK IT'S ESSENTIAL THAT THE JURY HEARS ABOUT IT.
JUDGE DAVILA: IF SHE TESTIFIES THAT SHE'S DOING OTHER WORK OR SOMETHING LIKE THAT, THAT'S FINE. I DON'T THINK THERE'S ANY OBJECTION.
MR. WADE: I JUST WANT TO BE CAREFUL BECAUSE THERE ARE SMALL QUESTIONS THAT ARE BEING ASKED HERE, AND THEY'RE ELICITING A NARRATIVE THAT IS LONG. SO I DON'T WANT TO -- I WOULD ASK THAT THE WITNESS BE CUT OFF BY THE COURT IF SHE STARTS TO GO INTO THIS. I DON'T WANT TO BE IN A POSITION TO CUT OFF THE WITNESS, BUT IF THERE'S A QUESTION ABOUT ARE YOU CONTINUING TO WORK? WELL, SHE'S BEEN CUED UP TO GIVE THIS ANSWER, AND SHE COULD VERY WELL GIVE THE WHOLE ANSWER. IF COUNSEL WANTS TO ASK A LEADING QUESTION TO KIND OF CAP IT OFF THAT IS A YES OR NO THAT DOESN'T GO INTO THIS, I HAVE NO OBJECTION.
JUDGE DAVILA: I THINK THE POINT IS THAT SHE'S NOT IN LAB WORK PER SE, SHE'S NOT WORKING IN A LAB ANYMORE, SHE'S DOING SOMETHING ELSE.
MR. BOSTIC: CORRECT.
JUDGE DAVILA: I THINK THAT'S FAIR.
MR. BOSTIC: IT IS MY INTENTION TO ASK A NARROWED QUESTION TO CAP THINGS OFF AS COUNSEL SAYS.
JUDGE DAVILA: AND YOU'RE DONE THEN?
MR. BOSTIC: CORRECT.
JUDGE DAVILA: AND THEN WE HAVE ABOUT 15 MINUTES.
JUDGE DAVILA: I DO. THANK YOU VERY MUCH.
(END OF DISCUSSION AT SIDE-BAR.)
JUDGE DAVILA: THANK YOU. WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. THE WITNESS IS ON THE STAND. I'LL SUSTAIN THE OBJECTION. THE OBJECTION IS SUSTAINED. YOU CAN ASK ANOTHER QUESTION, THOUGH, MR. BOSTIC.
BY MR. BOSTIC:
MR. BOSTIC: MS. CHEUNG, YOU NO LONGER WORK IN LAB TESTING; IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. BOSTIC: AND YOU'RE NOW SELF-EMPLOYED AT A NONPROFIT; IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. BOSTIC: NO FURTHER QUESTIONS, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU. CROSS-EXAMINATION?
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: YES.
JUDGE DAVILA: YES, PLEASE.
CROSS-EXAMINATION BY MR. WADE:
ERIKA CHEUNG: GOOD AFTERNOON.
MR. WADE: MY NAME IS LANCE WADE, AND I REPRESENT MS. HOLMES. I'M GOING TO ASK YOU A FEW QUESTIONS RELATING TO THE TOPICS THAT YOU'VE TESTIFIED TO HERE TODAY.
ERIKA CHEUNG: OKAY.
ERIKA CHEUNG: OKAY.
ERIKA CHEUNG: YES, THAT'S CORRECT.
ERIKA CHEUNG: MY POSITION THERE WAS A LAB ASSOCIATE.
ERIKA CHEUNG: WHEN I FIRST STARTED WORKING WITHIN THE RESEARCH AND DEVELOPMENT LAB.
ERIKA CHEUNG: WAS SHARADA SIVARAMAN AND EMMA.
JUDGE DAVILA: EXCUSE ME. CAN YOU PULL THE MICROPHONE A LITTLE BIT CLOSER.
ERIKA CHEUNG: YEAH. SORRY. I APOLOGIZE.
JUDGE DAVILA: THAT IS GOOD. THANK YOU.
BY MR. WADE:
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I KNOW SHE HAS A PH.D., BUT I DON'T REMEMBER IN WHAT.
ERIKA CHEUNG: I'M NOT SURE. I COULDN'T CONFIRM THAT.
ERIKA CHEUNG: MY --
ERIKA CHEUNG: I DID AS A LAB ASSOCIATE.
ERIKA CHEUNG: OH, WE HAD TEAM LEADS. SO FOR CERTAIN PROJECTS WE INTERACT WITH EMMA, WHO WAS THE TEAM LEAD SCIENTIST. AND THEN FOR OTHER PROJECTS WE WOULD INTERACT DIRECTLY WITH SHARADA.
ERIKA CHEUNG: I THINK IT'S EMMA LIU, L-I-U.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: WE WERE ALL INVOLVED IN THE ELISA TEAM.
ERIKA CHEUNG: EMMA LIU, SHARADA SIVARAMAN, AND MYSELF.
MR. WADE: AND WE'LL TRY TO SEPARATE OUR QUESTIONS AND ANSWERS HERE JUST TO MAKE OUR LIFE EASIER FOR THE COURT REPORTER. I'LL DO MY BEST, OKAY?
ERIKA CHEUNG: OKAY.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: DO YOU WANT THE -- IS THERE A PARTICULAR STRUCTURE THAT YOU WOULD PREFER?
ERIKA CHEUNG: DR. SIVARAMAN.
ERIKA CHEUNG: YEAH. SO EMMA WAS BELOW RAN, R-A-N, H-U, NAHAL. AND TO MY RECOLLECTION THOSE WERE THE THREE THAT I REMEMBER AT THIS MOMENT.
ERIKA CHEUNG: I DO.
MR. WADE: AND INSIDE OF THE BINDER WITHIN THE FRONT COVER I THINK THERE'S A DOCUMENT, EXHIBIT 1176.
ERIKA CHEUNG: UM -- OH, I SEE.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES. SO READ OUT THE TEAM MEMBERS AND THEIR PROSPECTIVE ROLES?
MR. WADE: YEAH. I'M JUST TRYING TO UNDERSTAND THE TYPE OF TEAM THAT YOU WERE WORKING ON IN R&D. AND SO IF YOU COULD IDENTIFY THE TEAM MEMBERS, THAT WOULD BE HELPFUL?
ERIKA CHEUNG: OKAY. SO THE CORE TEAM MEMBERS THAT ARE LISTED HERE, IT SAYS CORE ELISA TEAM. SO WHEN I STARTED WORKING IN THE RESEARCH AND DEVELOPMENT TEAM, WE HAD THE CORE ELISA TEAM THAT WAS PERMANENTLY POSITIONED THERE, BUT THEY NEEDED A LOT OF HELP. SO THERE WERE OTHER MEMBERS OF OTHER GROUPS AT THERANOS THAT WERE ALSO INVOLVED, AND HENCE WHY THIS EMAIL STATES THE CORE ELISA TEAM. SO AT THE TOP THERE WAS SHARADA, WHO WAS SORT OF THE HEAD OF THE ELISA TEAM. AND THEN RAN, AMY, LING. RAN WAS A TEAM LEAD. I DON'T REMEMBER AMY ALL THAT WELL. LING WAS A PH.D. AS WELL. SALINA WAS A RESEARCH ASSOCIATE. EMMA WAS A TEAM LEAD, ALSO PH.D. NAHAL WAS ANOTHER TEAM LEAD. SHE WAS ALSO A PH.D. TIFFANY I BELIEVE WAS A RESEARCH ASSOCIATE. MICHELLE WAS A RESEARCH ASSOCIATE. ALSO TIFFANY AND MICHELLE HAD PH.D.'S. NILI J WAS -- I DON'T REMEMBER HER POSITION. UYEN DO WAS A LAB ASSOCIATE AS WELL, BUT SHE HAD PROBABLY ABOUT ONE TO TWO YEARS EXPERIENCE. SO SHE HAD WORKED IN THE COMPANY FOR A WHILE. SAMANTHA AS WELL WAS A LAB ASSOCIATE. SHE WORKED WITHIN THE COMPANY FOR QUITE -- MAYBE ONE TO TWO YEARS. DARREN WAS ALSO A LAB ASSOCIATE. HE WORKED IN THE COMPANY FOR ONE TO TWO YEARS. ANDREW KIM AS WELL WAS A LAB ASSOCIATE, AND HE MAY HAVE EVEN WORKED A LITTLE BIT LONGER THAN TWO YEARS.
ERIKA CHEUNG: THAT'S THE CORE ELISA TEAM, YES.
JUDGE DAVILA: THIS IS 1176?
JUDGE DAVILA: ANY OBJECTION?
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 1176 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
ERIKA CHEUNG: OKAY.
MR. WADE: AS WE PULL THAT UP, THE TEAM THAT WE JUST IDENTIFIED IS THE CORE ELISA TEAM IDENTIFIED THERE?
ERIKA CHEUNG: YES.
MR. WADE: AND WHAT WERE THE -- DESCRIBE THE WORK OF THE CORE ELISA TEAM AT THE TIME YOU JOINED THE COMPANY?
ERIKA CHEUNG: AT THE TIME I JOINED THE COMPANY THE CORE ROLE WAS THE DEVELOPMENT OF NEW BIOCHEMICAL TESTS, AND THE SECONDARY ROLE WAS THE VALIDATION EXPERIMENTS THAT WE TALKED ABOUT EARLIER, ESSENTIALLY OF ASSAYS THAT HAD ALREADY BEEN DEVELOPED FOR THE EDISON DEVICES AND ALL OF THE SURROUNDING RESPONSIBILITIES THAT COME WITH THOSE SORT OF KEY FUNCTIONS.
MR. WADE: AND THE ASSAY WORK THAT THIS TEAM WAS DOING WAS FOCUSSED ON DEVELOPING SMALL SAMPLE ASSAYS?
ERIKA CHEUNG: ON THE FINGERSTICK ASSAYS, YES.
MR. WADE: AND DO YOU RECALL ABOUT HOW MANY FINGERSTICK ASSAYS THAT THEY HAD DEVELOPED IN R&D AT THIS TIME?
ERIKA CHEUNG: IN TERMS OF WHAT WAS IN DEVELOPMENT OR WHAT WAS BEING VALIDATED FOR THE CLINICAL LAB?
ERIKA CHEUNG: WHAT WAS IN DEVELOPMENT FOR R&D? I CAN'T BE CERTAIN ABOUT THE NUMBER, BUT WHEN I WAS THERE, THERE WAS PROBABLY ABOUT 12.
ERIKA CHEUNG: YES.
MR. WADE: AND IF YOU LOOK AT THE NEW ELISA MEMBERS THERE ARE THREE ADDITIONAL MEMBERS THERE: MELISSA, JAMIE LIU, AND YOURSELF; CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
ERIKA CHEUNG: MCCARTHY.
MR. WADE: MCCARTHY. AND THIS IS A NEW ELISA TEAM. THIS IS RIGHT AROUND THE TIME YOU JOINED THE COMPANY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND THE NEXT PART OF THE EMAIL IDENTIFIES THE BINDERS TEAM. AND YOU TALKED A LITTLE BIT ABOUT BINDERS ON YOUR DIRECT TESTIMONY. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND CAN YOU EXPLAIN TO US WHAT WORK THE BINDERS TEAM DID IN CONNECTION WITH THE ELISA WORK AND THE R&D WORK?
ERIKA CHEUNG: YES. SO IN ORDER TO RUN AN ELISA YOU HAVE TO HAVE ANTIBODIES AND VARIOUS TYPES OF REAGENTS IN ORDER TO BE ABLE TO DO THAT. SO BINDERS WORKED VERY CLOSELY WITH THE ELISA TEAM BECAUSE DEPENDING ON WHAT TYPE OF ASSAY YOU WERE RUNNING, YOU NEEDED TO HAVE THAT PRECURSOR COATING IN ORDER TO EFFECTIVELY RUN THE ELISA'S EDISON TEST. BINDERS WAS SEPARATED FROM ELISA, BUT THERE WAS A PERIOD THAT BINDERS HAD COMBINED WITH ELISA BECAUSE WE NEEDED HELP RUNNING THE VALUATION STUDIES?
MR. WADE: OKAY. AND IS THIS LIST THAT IS IDENTIFIED IN EXHIBIT 1176, IS THAT TO THE BEST OF YOUR RECOLLECTION AN ACCURATE REFLECTION OF THE BINDERS TEAM AT THE TIME YOU JOINED THE COMPANY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: NO. I THINK BECAUSE ARUNA HAD I THINK A MORE -- -- I COULD BE WRONG ABOUT THAT, BUT I WAS UNDER THE IMPRESSION THAT ARUNA WAS THE HEAD OF THE BINDERS TEAM.
MR. WADE: OKAY. FAIR ENOUGH. BUT MR. SHULTZ WAS ONE OF THE MORE JUNIOR PEOPLE ON THE TEAM? HE HAD JUST JOINED THE COMPANY?
ERIKA CHEUNG: YES.
MR. WADE: AND IN ADDITION TO THE ELISA TEAM WITHIN THE R&D, WERE THERE OTHER TEAMS WORKING ON OTHER TYPES OF ASSAYS?
ERIKA CHEUNG: YES.
JUDGE DAVILA: WHY DON'T WE GET THE ANSWER TO THAT QUESTION AFTER OUR BREAK.
JUDGE DAVILA: IT WILL HELP YOUR LUNCH. IT WILL HELP YOUR LUNCH. SO LET'S TAKE A BREAK. I TOLD YOU IT'S 12:45 OR 12:46 RIGHT NOW. LADIES AND GENTLEMEN, I THINK I TOLD YOU HOPEFULLY WE COULD COME BACK AT 1:30, 1:30, AND THEN WE'LL GO UNTIL 3:00 O'CLOCK I THINK. ALL RIGHT. HAVE A GOOD LUNCH. HAVE A GOOD BREAK, FOLKS. REMEMBER THE ADMONITION THAT IS STILL IN PLACE.
JUDGE DAVILA: MS. CHEUNG, WE'LL SEE YOU BACK THEN AS WELL. THANK YOU.
(LUNCH RECESS TAKEN AT 12:46 P.M.) AFTERNOON SESSION
(COURT CONVENED AT 1:34 P.M.)
(JURY IN AT 1:34 P.M.)
JUDGE DAVILA: WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. OUR JURY AND ALTERNATES ARE ALL PRESENT. MS. CHEUNG IS ON THE STAND. MS. CHEUNG, JUST TO REMIND YOU OF THE QUESTION, I'LL ASK MR. WADE TO REPEAT HIS QUESTION, AND THEN WE'LL END THE SUSPENSE OF THAT. MR. WADE.
MR. WADE: MS. CHEUNG, I THINK I WAS ASKING YOU THE EVER-SUSPENSEFUL QUESTION BEFORE THE BREAK ABOUT THE OTHER ASSAY DEVELOPMENT TEAMS WITHIN THE R&D GROUP. WERE THERE OTHERS?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: THERE WERE -- CAN I LIST THEM OUT? SO MICROBIOLOGY, CYTOMETRY, GENERAL CHEMISTRY, ELISA, BINDERS, AND THEN THERE WAS LIKE A REAGENT TEAM AS WELL. SO IN TERMS OF R&D, THE ADDITIONAL OTHERS WERE THREE. SO MICROBIO, GENERAL CHEMISTRY, AND CYTOMETRY.
ERIKA CHEUNG: I FORGOT HIS NAME.
ERIKA CHEUNG: NO. THAT WAS THE GENERAL CHEMISTRY TEAM.
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: PAUL PATEL?
ERIKA CHEUNG: I COULDN'T BE CERTAIN OF THAT.
ERIKA CHEUNG: NISHIT DOSHI.
ERIKA CHEUNG: OH, YES. YES, ACTUALLY CHINMAY WAS THE HEAD OF CYTOMETRY, AND THEN -- YEAH.
ERIKA CHEUNG: I BELIEVE SO.
ERIKA CHEUNG: THE MICROBIOLOGY GROUP?
ERIKA CHEUNG: I DON'T REMEMBER WHO THE LEAD FOR THE MICROBIOLOGY GROUP.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SOME OF THEM.
ERIKA CHEUNG: ELISA WAS THE LARGEST TEAM, BUT IT WOULD BE PROBABLY A SIMILAR SIZE AS THE BINDERS TEAM OF THE LIST THAT WE SAW. SO LET'S SAY GIVE OR TAKE LIKE ANYWHERE BETWEEN 5 TO 12 PEOPLE.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND I THINK BEFORE THE BREAK I SUGGESTED THAT DR. SIVARAMAN HAD A PH.D. RELATING TO IMMUNOLOGY. WAS IT ACTUALLY BIOCHEMISTRY THAT SHE HAD A PH.D. IN?
ERIKA CHEUNG: I CAN'T BE CERTAIN.
MR. WADE: OKAY. DO YOU KNOW HOW LONG THIS R&D ASSAY TEAM HAD BEEN WORKING TO DEVELOP ASSAYS PRIOR TO THE TIME THAT YOU JOINED THE COMPANY?
MR. WADE: AND AFTER A FEW MONTHS WITHIN THE R&D GROUP, I BELIEVE YOU TESTIFIED THAT YOU SHIFTED OVER TO CLIA?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I STILL MAINTAINED THE SAME TITLE, LAB ASSOCIATE.
MR. WADE: OKAY. SO YOU'RE STILL A LAB ASSOCIATE. AND WERE THERE OTHER LAB ASSOCIATES WITHIN THE LAB?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: RELATED TO THE EDISON DEVICES?
ERIKA CHEUNG: RELATING TO THE WHOLE CLIA LAB? SO RELATED TO THE EDISON DEVICES, WHILE I FIRST STARTED THAT TRANSITION THERE WERE FOUR OF US. THEN IN TERMS OF GENERAL CHEMISTRY THERE WERE AT LEAST TWO OTHERS. AND THEN FOR CYTOMETRY IT WAS PROBABLY AGAIN, LIKE, TWO TO FOUR PEOPLE.
ERIKA CHEUNG: YES.
MR. WADE: NOW, I WASN'T CLEAR IN YOUR ANSWER. WAS THAT JUST FOR THE ELISA OR JUST FOR EDISON ASSAYS OR FOR ALL OF THE ASSAYS THAT THE COMPANY OFFERED?
ERIKA CHEUNG: FOR ALL OF THE ASSAYS THAT THE COMPANY OFFERED FOR FINGERSTICK SAMPLES.
ERIKA CHEUNG: YEP.
ERIKA CHEUNG: YES, ROUGHLY.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO FOR THE EDISON DEVICES IT'S ROMINA RIENER; JAMIE LIU, SPELLED L-I-U; AURELIE SOUPPE; AND THEN MYSELF, ERIKA CHEUNG; AND THEN MELISSA MCCARTHY WAS PART OF THE GENERAL CHEMISTRY TEAM; AND BRIAN BAILEY. IN TERMS OF THE PEOPLE IN CYTOMETRY, I DON'T REMEMBER. I DON'T KNOW. AND THEN THERE WERE A HANDFUL OF OTHER ASSOCIATES, BUT THERE WAS A LOT OF OVERLAP, LIKE BRIAN BAILEY, MELISSA MCCARTHY, WHO ALSO RAN THE CLIA LAB UPSTAIRS, THE UPSTAIRS LAB.
ERIKA CHEUNG: SO THEY RAN A LOT OF THE PREDICATE METHOD DEVICES, SO THERE'S A BIT OF OVERLAP. AND THAT'S ALL I CAN REMEMBER AT THIS MOMENT.
MR. WADE: BUT IF YOU HAD TO ESTIMATE IN TOTAL, ABOUT 20 LAB ASSOCIATES DO YOU THINK THROUGH THE WHOLE CLIA LAB?
ERIKA CHEUNG: I DON'T -- THERE WAS LESS THAN 20.
ERIKA CHEUNG: SO I WOULD REPORT IMMEDIATELY TO A CLINICAL LAB SCIENTIST WHEN IT RELATED TO PATIENT PROCESSING. THAT SHIFTED DEPENDING ON WHO WAS HIRED OR WHO WAS AVAILABLE. AND I REPORTED FOR QUALITY CONTROL INFORMATION TO MARK PANDORI, ADAM ROSENDORFF, AND LANGLY GEE. JUST TO CLARIFY, WE'RE TALKING ABOUT WHO I REPORTED TO IN THE CLINICAL LAB?
ERIKA CHEUNG: SO THOSE WERE THE PEOPLE THAT I REPORTED TO IN THAT CONTEXT. SAY IF WE HAD AN ISSUE WITH REAGENTS, I WOULD SOMETIMES TALK TO SURAJ SAKSENA ABOUT THE PRODUCTION SITE.
MR. WADE: I MAY HAVE ASKED A BAD QUESTION. I'M WONDERING IF THERE WAS SOMEONE WHO WAS YOUR MANAGEMENT SUPERVISOR? SO IF YOU HAD TO GET A DAY OFF APPROVED OR GET AN EXPENSE PAID OR SOMETHING ALONG THOSE LINES, DO YOU KNOW WHO YOUR MANAGEMENT SUPERVISOR WAS WITHIN THE ORGANIZATION?
ERIKA CHEUNG: MARK PANDORI.
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: MARK JOINED THE COMPANY IN LATE DECEMBER, EARLY JANUARY OR -- I'M SORRY, THE YEAR IS 2013, 2014.
ERIKA CHEUNG: NO. HE'S A PH.D.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I BELIEVE THAT HIS BACKGROUND IS IN MICROBIOLOGY. HE HAS A SPECIAL LICENSE THAT ALLOWED HIM TO RUN CERTAIN TYPES OF MEDICAL TESTS RELATED TO INFECTIOUS DISEASE. THAT WAS HIS MAIN BACKGROUND. HE DID EARLY DIAGNOSTICS FOR HIV DETECTION AND HAD WORKED I THINK PRIOR FOR LIKE PUBLIC HEALTH DEPARTMENTS.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: DR. ROSENDORFF WAS A PATHOLOGIST AND WAS A MEDICAL DOCTOR. THAT WAS THE EXTENT. I KNEW HE WAS A PATHOLOGIST SPECIALIZING IN DIAGNOSTICS, AND THAT'S THE EXTENT TO WHICH I REMEMBER.
ERIKA CHEUNG: I CAN'T RECALL.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: DR. SAKSENA INITIALLY WAS A LEAD SCIENTIST FOR THE BINDERS TEAM, AND THEN HE ENDED UP TRANSITIONING TO A POSITION WHERE HE WAS LEADING PRODUCTION. SO THERANOS HAD THIS SORT OF PROPRIETARY METHODOLOGY THAT THEY UTILIZED IN ORDER TO PRODUCE THE CARTRIDGES THAT WE WOULD TEST ON THE EDISON DEVICES, AND THERE WAS THIS SPECIALTY ROBOTIC SYSTEM THAT WOULD FILL THE CARTRIDGES WITH THE NECESSARY REAGENTS INSTEAD OF HAND FILLING THEM, AND HE WAS THE LEAD PERSON TO KIND OF INSTIGATE THOSE EFFORTS WHEN I WAS WORKING THERE.
MR. WADE: OKAY. AND AT THE TIME THAT YOU WENT OVER TO WORK IN THE CLIA LAB, WERE YOU AWARE THAT THE LABORATORY WAS CERTIFIED UNDER CLIA?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: 7603?
MR. WADE: YES. DO YOU HAVE A COPY OF THAT? IT'S A THICK DOCUMENT IF THAT HELPS YOU FIND IT. MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
BY MR. WADE:
ERIKA CHEUNG: YES.
MR. WADE: I PROMISE I WON'T ASK YOU TOO MANY QUESTIONS. ARE YOU FAMILIAR WITH THIS DOCUMENT GENERALLY?
ERIKA CHEUNG: GENERALLY.
ERIKA CHEUNG: ESSENTIALLY THESE ARE THE CENTER FOR MEDICAID AND MEDICAL SERVICES, RULES AND RELATIONS AND POLICIES AROUND RUNNING A CLINICAL LABORATORY.
MR. WADE: THE DIFFERENT FEDERAL REGULATIONS THAT SET FORTH ALL OF THE REQUIREMENTS FOR RUNNING A CLIA LAB?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: ROUGHLY, YES. NOT ALL OF THEM BUT SOME OF THEM.
ERIKA CHEUNG: SOME OF THEM, BUT NOT ALL OF THEM.
MR. WADE: OKAY. AND JUST SO WE'RE CLEAR, I KNOW THAT SOME TIME HAS PASSED SINCE YOU WORKED AT THE COMPANY, AND THE QUESTIONS THAT I'M ASKING YOU, UNLESS I SPECIFY OTHERWISE, I AM FOCUSSED ON YOUR KNOWLEDGE AT THE TIME THAT YOU WORKED FOR THE COMPANY, OKAY?
ERIKA CHEUNG: OKAY.
MR. WADE: AND THERE'S A SET OF REGULATIONS THAT RELATE TO TESTING PERSONNEL STANDARDS. WERE YOU AWARE OF THAT?
ERIKA CHEUNG: IN -- YES.
MR. WADE: AT THE TIME YOU WERE WORKING AT THERANOS, WERE YOU AWARE OF THE REGULATIONS THAT RELATED TO TESTING PERSONNEL STANDARDS?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND JUST FOR THE RECORD, WE'RE -- 7603 IS ABOUT 125 PAGES OF REGULATIONS; IS THAT RIGHT?
ERIKA CHEUNG: I CAN'T BE CERTAIN BECAUSE I CAN'T RECALL THEM, BUT, YES, IT'S A LARGE DOCUMENT.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: WERE YOU AWARE AT THE TIME THAT YOU WERE WORKING AT THE COMPANY THAT THERE WERE CERTAIN CREDENTIALS THAT YOU NEEDED TO HOLD LEADERSHIP POSITIONS WITHIN CLIA?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO DEPENDING ON WHAT TYPE OF RESPONSIBILITIES AND WHAT TYPE OF THINGS THAT YOU WERE ACCOMPLISHING, YOU NEEDED DIFFERENT TYPES OF DEGREES. SO, FOR EXAMPLE, FOR A LAB ASSOCIATE THERE ARE ONLY A SUBSET OF RESPONSIBILITIES THAT THEY COULD HAVE. THEY TEND TO ONLY BE ABLE TO RUN A LOW COMPLEXITY TEST, AND YOU HAVE TO HAVE A BACHELOR'S DEGREE. THEN IF YOU ARE REVIEWING QUALITY CONTROLS OR GIVING PATIENTS A SAMPLE, YOU HAVE TO BE A CLINICAL LAB SCIENTIST. AND THERE ARE DIFFERENT QUALIFICATIONS THAT ALLOW DIFFERENT TYPE OF PERSONNEL TO ENGAGE WITH MORE AND MORE COMPLEX RESPONSIBILITIES.
ERIKA CHEUNG: I IMAGINE THAT'S THE MEDICAL DIRECTOR.
ERIKA CHEUNG: THE LAB DIRECTOR.
MR. WADE: OKAY. AND THERE ARE SPECIFIC QUALIFICATIONS UNDER THE REGULATIONS. WERE YOU AWARE THAT THERE WERE SPECIAL QUALIFICATIONS UNDER THE REGULATIONS FOR A LAB DIRECTOR?
ERIKA CHEUNG: YES.
MR. WADE: WHAT LEVEL -- AND I UNDERSTAND THESE QUALIFICATIONS ARE LARGELY BASED UPON EXPERIENCE AND AGE AND THINGS LIKE THAT, BUT WHAT LEVEL OF POSITION WERE YOU QUALIFIED FOR UNDER THE REGULATIONS?
ERIKA CHEUNG: A VERY LOW COMPLEXITY PROCESSING PATIENT SAMPLES, RUNNING QC'S. IT WAS THE BASIC OPERATIONS OF RUNNING LAB TESTS.
MR. WADE: WELL, DON'T SELL YOURSELF SHORT. YOU HAD TO HAVE A FOUR-YEAR DEGREE AND A SCIENCE BACKGROUND; CORRECT?
ERIKA CHEUNG: YES, A BACHELOR'S DEGREE.
ERIKA CHEUNG: YES.
MR. WADE: AND WHEN YOU MOVED OVER TO THE LAB, I THINK YOU MENTIONED THAT YOU ACTUALLY INTERACTED WITH DR. ROSENDORFF A BIT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND DID YOU UNDERSTAND, BROADLY SPEAKING, THAT HE HAD SORT OF ULTIMATE REGULATORY RESPONSIBILITY FOR THE LAB?
ERIKA CHEUNG: YES.
MR. WADE: AND HAVE YOU REFERRED TO THE TERM -- HAVE YOU EVER HEARD THE TERM HIGH COMPLEXITY LAB?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: A HIGH COMPLEXITY LAB IS WHERE YOU'RE ABLE TO RUN HIGH COMPLEXITY TESTS, AND THAT WOULD BE MY UNDERSTANDING OF WHAT THAT IS.
MR. WADE: OKAY. WOULD -- DO YOU RECALL IT BEING A HIGH COMPLEXITY LAB? DOES THAT HELP REFRESH YOUR RECOLLECTION?
ERIKA CHEUNG: I COULDN'T BE CERTAIN.
MR. WADE: OKAY. AND AT THE TIME THAT YOU WERE WORKING IN THE LAB, WERE YOU ALSO AWARE THAT THERE WERE STATE QUALIFICATIONS THAT RELATED TO SOME OF THESE ISSUES AS WELL?
ERIKA CHEUNG: I CAN'T, I CAN'T REMEMBER.
ERIKA CHEUNG: YEAH.
MR. WADE: OKAY. DID, DID -- AT THE TIME YOU WERE WORKING AT THE LAB, DID YOU HAVE A GENERAL UNDERSTANDING THAT A LAB DIRECTOR NEEDED TO BE EITHER A MEDICAL DIRECTOR OR A PH.D. WITH CERTAIN OTHER CREDENTIALS?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES, THAT WAS MY UNDERSTANDING.
ERIKA CHEUNG: YES.
MR. WADE: AND ARE YOU AWARE THAT UNDER THE REGULATIONS IT WAS -- THERE ARE PARTICULAR PEOPLE WHO HAVE RESPONSIBILITY FOR ENSURING THE ACCURACY AND RELIABILITY OF TESTS?
ERIKA CHEUNG: CAN YOU REPEAT THAT QUESTION?
MR. WADE: YES. OF COURSE. ARE YOU AWARE THAT UNDER THE CLIA REGULATIONS THERE ARE CERTAIN -- THERE'S A CERTAIN PERSON WITHIN THE LAB WHO HAS RESPONSIBILITY FOR ENSURING THE ACCURACY AND RELIABILITY OF TESTS?
ERIKA CHEUNG: NO, I DIDN'T KNOW IT WAS A CERTAIN PERSON.
MR. WADE: OKAY. AND DID YOU KNOW THAT TESTS HAD TO BE VERIFIED AND VALIDATED BEFORE THEY COULD BE OFFERED IN A LAB?
ERIKA CHEUNG: YES.
MR. WADE: OKAY. DO YOU KNOW ULTIMATELY WHOSE RESPONSIBILITY IT WAS TO ENSURE THAT A TEST WAS VERIFIED AND VALIDATED?
ERIKA CHEUNG: MY UNDERSTANDING WAS THAT IT WAS THERANOS, THE ORGANIZATION.
MR. WADE: OKAY. WELL, LET ME SEE IF I CAN REFRESH YOUR RECOLLECTION. IF YOU WOULD TURN TO THE PAGE ENDING 792.
ERIKA CHEUNG: 792?
MR. WADE: ACTUALLY 791 WILL HELP ORIENT YOU A LITTLE BIT. AND IF YOU COULD JUST TAKE A MINUTE --
ERIKA CHEUNG: I DON'T HAVE THIS DOCUMENT.
ERIKA CHEUNG: OKAY.
MR. WADE: AND I'M ON THE BATES LABELLED ON THE BOTTOM WHICH SAYS 791 OR WITHIN THE REGULATIONS ITSELF IT'S PAGE 636.
ERIKA CHEUNG: OKAY.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND JUST TAKE A MINUTE AND READ THAT SECTION UP THROUGH NUMBER 4 ON THE FOLLOWING PAGE.
JUDGE DAVILA: READ IT TO HERSELF?
BY MR. WADE:
(PAUSE IN PROCEEDINGS.)
ERIKA CHEUNG: AND YOU SAID UP TO 4?
BY MR. WADE:
ERIKA CHEUNG: I'VE FINISHED.
MR. WADE: OKAY. AND LOOKING AT THIS, DOES THIS RECOLLECTION YOUR RECOLLECTION AS TO WHICH PERSON HAS RESPONSIBILITY UNDER THE REGULATIONS FOR ENSURING THAT TESTS ARE ACCURATE AND RELIABLE?
ERIKA CHEUNG: THIS WOULD BE THE MEDICAL DIRECTOR OF --
ERIKA CHEUNG: THE LABORATORY DIRECTOR.
MR. WADE: OKAY. AND IN ADDITION TO THE LAB -- I'M SORRY. I'LL STRIKE THAT. IN DOING THAT, WERE YOU AWARE OF A PROCESS WITHIN THE THERANOS CLIA LAB, THAT THE LAB WENT TO, TO GET ITSELF COMFORTABLE AND ENSURE THAT THE TEST WAS ACCURATE AND RELIABLE AND READY TO BE OFFERED TO A PATIENT BEFORE IT WAS OFFERED TO A PATIENT?
ERIKA CHEUNG: CAN YOU REPEAT THAT QUESTION?
MR. WADE: SURE. LET ME PROVIDE A LITTLE DIRECTION. DO YOU RECALL TALKING ABOUT THE VALIDATION PROCESS WITHIN THE CLIA LAB?
ERIKA CHEUNG: YES.
MR. WADE: AND WAS THAT A PROCESS BY WHICH THE COMPANY -- THE LABORATORY PROFESSIONALS PERFORMED CERTAIN FUNCTIONS TO ENSURE THAT THE TEST WAS SUFFICIENTLY ACCURATE AND RELIABLE AND THAT IT COULD BE USED ON PATIENTS?
ERIKA CHEUNG: SO FOR CLARIFICATION, THE VALIDATION STUDIES WERE CONDUCTED PRIOR TO ESSENTIALLY ASSESS WHAT THE ACCURACY AND RELIABILITY OF THE TESTS WERE.
MR. WADE: AND THEN ONLY ONCE THEY HIT A CERTAIN STANDARD WOULD THEY BE APPROPRIATE FOR USE IN THE CLIA LAB ON PATIENTS; CORRECT?
ERIKA CHEUNG: CORRECT.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO THE DOCUMENTS THAT THEY USED, SO THERE WERE VALIDATION REPORTS, AND THEN IN ADDITION TO THAT THERE WERE STANDARD OPERATING PROCEDURES. ONCE IT WAS APPROVED THAT YOU WOULD BE ABLE TO, BE ABLE TO RUN THE THERANOS DEVELOPED TESTS.
MR. WADE: AND WERE THOSE DOCUMENTS THAT YOU WERE FAMILIAR WITH WHILE YOU WERE WORKING AT THE COMPANY?
ERIKA CHEUNG: I WAS FAMILIAR WITH THE STANDARD OPERATING PROCEDURES AND THEN HAD SEEN BUT WASN'T NECESSARILY SUPER CLOSE TO THE VALIDATION REPORTS.
MR. WADE: THE VALIDATION REPORT WAS SORT OF A GATEWAY DOCUMENT, IF YOU WILL, BEFORE THE TEST COULD BE OFFERED?
ERIKA CHEUNG: YES.
MR. WADE: AND THEN ONCE IT WAS DEEMED SAFE, THE COMPANY WOULD HAVE TO CREATE AN SOP TO EXPLAIN TO LAB ASSOCIATES HOW TO ACTUALLY OPERATE THE TEST WITHIN THE LAB; IS THAT RIGHT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. WADE: AND THERE WAS A POINT IN TIME WHERE I BELIEVE THAT DR. PANDORI ASKED FOR YOUR ASSISTANCE TO HELP GET THOSE PERFECTLY ACCURATE; IS THAT RIGHT?
ERIKA CHEUNG: THAT IS CORRECT.
MR. WADE: OKAY. I'LL SHOW YOU A COUPLE OF THOSE IN A MINUTE. THAT MIGHT HELP REFRESH YOUR RECOLLECTION. BEFORE I GET TO THAT, IN ADDITION TO THE FOLKS IN THE LAB WHO WERE FORMALLY ASSIGNED TO THE LAB, I THINK YOU MENTIONED DR. DANIEL YOUNG ON SOME OF YOUR DIRECT TESTIMONY. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: FROM M.I.T.
ERIKA CHEUNG: MASSACHUSETTS INSTITUTE OF TECHNOLOGY.
ERIKA CHEUNG: I DON'T REMEMBER, BUT YEAH.
(LAUGHTER.)
BY MR. WADE:
ERIKA CHEUNG: IT WAS IN ENGINEERING, I BELIEVE. I REMEMBER READING HIS DISSERTATION, SO I BELIEVE IT WAS IN ENGINEERING, BUT I DON'T KNOW THE SPECIFICITY OF WHAT TYPE OF ENGINEERING.
ERIKA CHEUNG: I DON'T REMEMBER.
ERIKA CHEUNG: FAIRLY COMPLICATED.
MR. WADE: AND DID DR. YOUNG LEAD UP A GROUP OF STATISTICIANS IN A BIOSTATISTICAL ANALYSIS GROUP?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I ONLY INTERFACED WITH ONE OF THEM, SO I DON'T KNOW HOW LARGE THE GROUP WAS. BUT I REMEMBER ONE STATISTICIAN.
ERIKA CHEUNG: KARTHIK.
MR. WADE: SO YOU INTERACTED, IN ADDITION TO MR. YOUNG, YOU ALSO INTERACTED WITH KARTHIK. WHAT WAS KARTHIK'S LAST NAME?
ERIKA CHEUNG: I DON'T REMEMBER WHAT HIS LAST NAME WAS.
ERIKA CHEUNG: EVERY ONCE IN A WHILE, YES.
MR. WADE: OKAY. NOW, WE TALKED A LITTLE BIT ABOUT THE CLIA VALIDATION REPORTS. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND YOU TESTIFIED ON DIRECT, I THINK, SOMEWHERE ALONG THE LINES OF THE ASSAY DEVELOPMENT WOULD START IN R&D, AND THEN IT WOULD MAKE ITS WAY OVER TO CLIA ONCE IT WAS SUFFICIENTLY RELIABLE AND ACCURATE; IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
ERIKA CHEUNG: GO THROUGH THE VALIDATION --
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND DO YOU RECALL THERE BEING DOCUMENTS THAT WERE CREATED BY THE R&D GROUP THAT RELATED TO THE WORK THAT THEY DID ON THE ASSAYS?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I DON'T REMEMBER THE SPECIFIC NAME, NO.
ERIKA CHEUNG: THIS DOCUMENT IS THE THYROID STIMULATING HORMONE, OR TSH, ASSAY DEVELOPMENT REPORT.
ERIKA CHEUNG: IT IS APRIL 4TH, 2011.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I DON'T REMEMBER.
MR. WADE: MS. NOYES PREPARED THIS DOCUMENT. AND I BELIEVE YOU MENTIONED THAT YOU WORKED ON THIS ASSAY A BIT AS WELL?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I DIDN'T READ THIS DOCUMENT IN CONNECTION TO MY WORK, THE ASSAY DEVELOPMENT REPORT FOR TSH, BECAUSE I MOSTLY WORKED ON VITAMIN D IN CONNECTION TO THE ASSAY DEVELOPMENT REPORT.
ERIKA CHEUNG: WITH VITAMIN D, HEPATITIS B, AND A COUPLE OF OTHER DIFFERENT ASSAYS. IT JUST DEPENDS. WE GOT ASSIGNED DIFFERENT ASSAYS DEPENDING ON WHAT WAS PRIORITY AT GIVEN DIFFERENT POINTS IN TIME.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: NOT TO THE POINT WHERE I WOULD HAVE SEEN THIS ASSAY DEVELOPMENT REPORT, NO.
MR. WADE: OKAY. WELL, LET ME SHOW YOU A COUPLE OF OTHERS AND SEE IF YOU'RE FAMILIAR WITH THOSE. CAN WE LOOK AT 9048. DO YOU SEE THAT DOCUMENT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: VITAMIN B12 ASSAY DEVELOPMENT REPORT.
ERIKA CHEUNG: I MAY HAVE RUN A COUPLE EXPERIMENTS BUT NOT EXTENSIVELY.
ERIKA CHEUNG: NOT THAT I CAN RECALL.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND SO THESE CHRONOLOGICALLY ARE DOCUMENTS, JUST FROM A PROCESS STANDPOINT, THAT DOCUMENT ALL OF THE WORK THAT IS DONE UP TO THE POINT WHERE IT SHIFTS OVER TO CLIA?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND CAN YOU JUST TELL US FROM A PROCESS STANDPOINT ALL THE WORK THAT WAS DONE BY THE R&D GROUP ON, SAY, VITAMIN D GROUP BEFORE IT WENT TO CLIA?
ERIKA CHEUNG: YES. SO IN TERMS OF THE PROCESS THAT THEY HAVE TO UNDERGO, THERE IS FIRST THE ASSAY DEVELOPMENT. SO YOU WOULD HAVE TO COME UP WITH THE ACTUAL ASSAYS FOR VITAMIN D. WHAT IS THE TEST? WHAT -- HAVE YOU SEEN ALREADY ON THE MARKET FOR, SAY, AN ELISA TEST? SO THERE WERE SCIENTISTS THAT ESSENTIALLY WOULD DO THE ASSAY DEVELOPMENT TO TRY AND FIGURE OUT, YOU KNOW, WHAT TYPE OF REAGENTS DO WE NEED TO USE, WHAT DOES THE PROCESS LOOK LIKE IN ORDER TO RUN AN ELISA FOR VITAMIN D. SO ONCE YOU DO AN ASSAY DEVELOPMENT, THEN IT'S THE CONVERSION OF THAT PARTICULAR ASSAY ON THE EDISON SYSTEM. AND THE SPECIFICS OF THE CARTRIDGE FORMAT, OF THE DILUTION BASED ON THE NANOTAINER, WHAT TYPE OF, YOU KNOW, COATING DO YOU NEED TO USE IN TERMS OF THE COLLECTION, IS IT JUST SERA, IS IT EDTA, IS IT HEPARIN. AND SO THERE'S A MULTITUDE OF DIFFERENT EXPERIMENTS THAT YOU RUN. THERE ARE MATRIX STUDIES TO SEE HOW THE FORMULATION AFFECTS THE CONCENTRATION OF THE SAMPLE THAT YOU'RE SPECIFICALLY TARGETING.
BECAUSE WE WERE RUNNING FINGERSTICK OVER VENOUS DREW, WHAT IS THE COMPARABLE BETWEEN THE FINGERSTICK AND THE VENOUS DRAW? SO THE ASSAY DEVELOPMENT, THE CONVERSION TO THE EDISON, RIGHT, AND THE FORMAT OF THE EDISON. THEN ONCE YOU KIND OF HAVE THAT PROCESS, THEN YOU GO TO THE ASSAY DEVELOPMENT REPORT WHERE YOU RUN A SERIES OF DIFFERENT EXPERIMENTS. SO YOU RUN THINGS LIKE PRECISION. HOW MANY TIMES ARE WE GETTING CLOSE TO THE SAME ANSWER CONSISTENTLY OVER A PERIOD OF TIME? YOU KNOW, WHAT IS THE STABILITY OF IT? WHAT IS THE SENSITIVITY? WHAT IS THE SPECIFICITY? WHAT IS THE ACCURACY? HOW DOES THE FINGERSTICK VERSUS THE VENOUS DRAW COMPARE TO ONE ANOTHER? SO THERE ARE A WHOLE MULTITUDE OF TESTS THAT YOU RUN FOR THE VALIDATION OF THAT. AND THEN THERE WERE LOTS OF NEW DEVELOPMENTS THAT WERE HAPPENING BECAUSE EVEN SAY THE BLOOD COLLECTION THAT WE WERE UTILIZING AT THERANOS, THEY HAD DIFFERENT ITERATIONS. SO YOU WOULD HAVE TO TEST AND SAY, OKAY, IF WE'RE DOING THE VERSION 1 OF THE BLOOD COLLECTION DEVICE VERSUS THE VERSION 2, HOW DO THOSE STACK UP TO ONE ANOTHER? ARE THERE DIFFERENCES VERSUS, YOU KNOW, THE THIRD OR WHATEVER ELSE? SO THERE WAS A WEALTH OF DIFFERENT EXPERIMENTS THAT WERE RUN IN CONNECTION TO THE GENERATION OF ONE PARTICULAR TEST IN THIS CASE FOR THE EDISON DEVICES.
ERIKA CHEUNG: IT IS A LOT OF WORK.
ERIKA CHEUNG: DEPENDING ON THE ASSAY, YEAH. IT CAN DEPEND ON HOW THE ASSAY IS, YES.
MR. WADE: AND MANY OF THESE ASSAYS THAT THIS R&D GROUP WAS WORKING ON WAS -- WEREN'T -- DID NOT EXIST IN SMALL SAMPLES PREVIOUSLY; CORRECT?
ERIKA CHEUNG: DIDN'T?
MR. WADE: IT WAS A BAD QUESTION. LET ME TRY AGAIN. MANY OF THE ASSAYS THAT WERE BEING OFFERED THAT WERE BEING DEVELOPED IN RESEARCH AND DEVELOPMENT HAD NEVER BEEN DEVELOPED ON A SMALL SAMPLE BEFORE; CORRECT?
ERIKA CHEUNG: SO -- CAN YOU REPHRASE THAT ONE MORE TIME.
MR. WADE: YEAH. LET ME BREAK IT INTO SOME PIECES. WE'RE TALKING ABOUT THE R&D ASSAY DEVELOPMENT WORK?
ERIKA CHEUNG: RIGHT. OKAY.
ERIKA CHEUNG: YES.
MR. WADE: AND MANY OF THE ASSAYS THAT THEY WERE WORKING ON, THERE WAS NOT A SMALL SAMPLE ASSAY THAT EXISTED IN THE MARKET PREVIOUSLY; RIGHT?
MR. BOSTIC: OBJECTION. 602, YOUR HONOR.
JUDGE DAVILA: YOU'RE ASKING IF SHE HAS PERSONAL KNOWLEDGE OF THIS IN THE INDUSTRY?
JUDGE DAVILA: DID YOU UNDERSTAND THE QUESTION?
ERIKA CHEUNG: I DID UNDERSTAND IT.
JUDGE DAVILA: OKAY. YOU CAN ANSWER IT.
ERIKA CHEUNG: SO THERE WERE. FOR EXAMPLE, FOR GENERAL CHEMISTRY THERE ARE POINT OF CARE DIAGNOSTICS THAT DO EXIST. SO THERE WAS THE ISTAT, I-S-T-A-T, THAT DID EXIST. AND GENERAL CHEMISTRY HAS THIS. AND THIS IS SOMETHING THAT YOU USE ON EMERGENCY VEHICLES, FOR EXAMPLE, IN ORDER TO QUICKLY BE ABLE TO DIAGNOSE A PATIENT. SOMETIMES YOU'LL HAVE THEM ESPECIALLY FOR ANYTHING RELATED TO DIABETES. I DON'T REMEMBER THE NAME OF THE MACHINE, BUT THERE ARE WAYS THAT YOU CAN RUN A1C OR DIFFERENT GLUCOSE TESTS BASED ON A FINGERSTICK. SO THERE ARE A COUPLE OF MANUFACTURES THAT DO OFFER POINT OF CARE DEVICES. THERE WAS ANOTHER ONE -- THERE ARE A LOT OF SMALL COMPANIES THAT DO THIS. SO THERE WAS ONE FOR TPSA OUT OF NEW YORK. THERE WERE A HANDFUL OF COMPANIES THAT WERE PROVIDING POINT OF CARE DIAGNOSTICS EVEN AT THAT TIME. BUT THERE WERE -- YEAH.
BY MR. WADE:
MR. WADE: AND MANY OF THEM, LIKE THE GLUCOSE MONITORS, FOR EXAMPLE, MANY OF THEM ARE FOCUSSED ON SINGLE DISCRETE ASSAYS. AND THERANOS WAS TRYING TO DEVELOP A WHOLE RANGE OF ASSAYS; RIGHT?
ERIKA CHEUNG: YES. THE ISTAT CAN DO A WHOLE PANEL OF VARIOUS CHEMISTRY ASSAYS SIMILAR TO WHAT THERANOS WAS ATTEMPTING TO DO WITH THEIR CHEMISTRY PANELS. BUT THE GLUCOSE MONITORING ONES ARE JUST, YES, DISCRETE ONE ASSAY.
MR. WADE: OKAY. AND THE PROCESS THAT YOU WERE JUST DESCRIBING WHERE ALL OF THAT WORK WAS DONE AND THE COMPARISONS WITH DIFFERENT METHODS WERE DONE AND YOU WERE LOOKING AT THE SAMPLE, ALL OF THAT WORK WAS DONE FOR EVERY ASSAY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND IT WAS ONLY ONCE IT SORT OF CLEARED THAT HURDLE THAT WE WOULD GET TO THE CLIA VALIDATION; RIGHT?
ERIKA CHEUNG: BEING ABLE TO INTEGRATE IT INTO THE CLINICAL LAB, YES.
MR. WADE: AND IN THAT CLINICAL VALIDATION PROCESS -- NOW, AGAIN, THIS IS A COMPLETELY SEPARATE PROCESS WHERE YOU THEN TRY TO PUT INTO THE CLIA LAB AND TO ENSURE IT'S SAFE FOR PATIENT USE; RIGHT?
ERIKA CHEUNG: CORRECT.
ERIKA CHEUNG: SO THAT SEPARATE PROCESS IS ESSENTIALLY ONCE WE GET THE OKAY FOR BEING ABLE TO START RUNNING PATIENTS UTILIZING THE EDISON DEVICES, RIGHT, LET'S JUST USE VITAMIN D AS AN EXAMPLE, THERE ARE CERTAIN REQUIREMENTS THAT YOU HAVE TO HAVE IN ORDER TO ACTUALLY RUN PATIENT SAMPLES. SO IT'S THINGS LIKE MAKING SURE THAT YOU HAVE A QUALITY CONTROL INFRASTRUCTURE SET UP. SO HOW MANY QUALITY CONTROLS DO RUN? HOW OFTEN DO YOU RUN? WHAT TYPES OF ISSUES ARE FLAGGED? IF THERE ARE FAILURES, HOW DO YOU RESOLVE THEM? HOW DO YOU TROUBLESHOOT THEM? THERE IS ALSO A LOT OF REAGENT CONTROL THAT YOU HAVE TO CONDUCT IN ORDER TO PROPERLY HAVE IT SET UP IN THE CLIA LAB BECAUSE THAT INFORMATION HAS TO BE RECORDED IN THE EVENT THAT THERE'S AN INSPECTION ON CLIA. THERE HAS TO BE PROPER TRAINING RECORDS AS WELL BECAUSE IF CLIA DOES -- OR CMS DOES AN INSPECTION, YOU HAVE TO ENSURE THAT PEOPLE ARE PROPERLY TRAINED APPROPRIATELY FOR CONDUCTING CERTAIN TYPES OF TESTS. SO ESSENTIALLY THERE'S A WHOLE ARRAY OF INFRASTRUCTURE YOU HAVE TO SET UP SPECIFICALLY FOR PROCESSING PATIENT SAMPLES IN A CLINICAL LAB.
ERIKA CHEUNG: YES.
MR. WADE: AND THEN THERE'S A WHOLE ANOTHER SET OF PROCEDURES THAT RELATE TO THE GENERAL OPERATIONAL LAB?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: ARE YOU ASKING IN THE CONTEXT OF HOW THEY WERE OPERATED AT THERANOS OR IN THE CONTEXT OF JUST GENERALLY?
MR. WADE: UNDER THE CLIA LAB, THE LAB DIRECTOR IS SUPPOSED TO SET UP ALL OF THESE PROCESSES AND PROCEDURES OF THE KIND THAT YOU'VE TALKED ABOUT; RIGHT?
ERIKA CHEUNG: YES.
MR. WADE: AND I WANT TO FOCUS -- YOUR WORK IN VALIDATING THOSE ASSAYS IN THE CLIA LAB WAS FOCUSSED ON THE IMMUNOASSAYS; RIGHT?
ERIKA CHEUNG: YES.
MR. WADE: AND THERE WAS A SEPARATE CLINICAL VALIDATION IN PROCESS FOR THE OTHER TYPES OF ASSAYS?
ERIKA CHEUNG: CORRECT.
ERIKA CHEUNG: NOT IN THE VALIDATION, NO.
MR. WADE: OKAY. LET ME LOOK -- AND THE PROCESS THAT YOU JUST DESCRIBED I THINK YOU SAID WAS DOCUMENTED IN A VALIDATION REPORT; RIGHT?
ERIKA CHEUNG: WHICH PROCESS?
ERIKA CHEUNG: SO THERE'S THE ASSAY VALIDATION IN TERMS OF THE APPROVAL OF WHETHER THIS IS AN ACCURATE, PRECISE, ADEQUATE TEST; AND THEN THE SORT OF CLIA PROCEDURES OF SETTING UP THE QC INFRASTRUCTURE, AND HOW TO TROUBLESHOOT CERTAIN ISSUES THAT ARISE, UNDERSTANDING CLINICAL RANGES AND THINGS OF THAT NATURE, THAT'S A SEPARATE DOCUMENT THAT WOULD TYPICALLY BE ARTICULATED IN THE STANDARD OPERATING PROCEDURE.
MR. WADE: OKAY. AND WE'LL TALK ABOUT SOME OF THOSE HERE A BIT. LET ME START WITH THE PARTICULAR ASSAY RELATED PROVISIONS.
ERIKA CHEUNG: OKAY.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: IT DEPENDS ON THE TEST.
ERIKA CHEUNG: I DON'T REMEMBER THE EXACT VALUES.
MR. WADE: HOW ABOUT FOR -- LET'S SEE SOME OF THE OTHER ONES YOU WORKED ON. HOW ABOUT FOR TOTAL TESTOSTERONE?
ERIKA CHEUNG: I WOULDN'T REMEMBER THE EXACT VALUES.
MR. WADE: DO YOU RECALL THE ACCURACY STANDARDS FOR ANY OF THE ASSAYS? I KNOW IT'S BEEN A LONG TIME. I'M NOT --
MR. WADE: OKAY. AND THERE'S ALSO SOME TALK ABOUT PRECISION IN YOUR TESTIMONY. DO YOU RECALL THAT?
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: NO, NOT AT THIS TIME, NO.
MR. WADE: NOW, I THINK YOU SAID -- IS IT -- STRIKE THAT. IS IT FAIR TO SAY THAT VITAMIN D WAS THE ASSAY THAT YOU PROBABLY WORKED THE MOST WITH?
ERIKA CHEUNG: IN VALIDATION OR IN CLINICAL LAB?
ERIKA CHEUNG: IN VALIDATION VITAMIN D, HEPATITIS B, SOME TPSA, MAYBE SOME TSH, BUT IT WAS -- YEAH. IT WAS MOSTLY IN REGARDS TO BEING ABLE TO RUN SOME OF THE EXPERIMENTS. IT WASN'T NECESSARILY IN THE ANALYSIS OF IT.
MR. WADE: OH, THAT'S FAIR. CAN YOU EXPLAIN -- CAN YOU GIVE US AN OVERVIEW OF THE WHOLE VALIDATION PROCESS AND WHAT ROLE YOU PLAYED WITHIN THE VALIDATION PROCESS?
ERIKA CHEUNG: SO, FOR EXAMPLE, IF WE NEEDED TO FIGURE OUT WHAT THE PRECISION OF VITAMIN D WAS, ESSENTIALLY WHAT YOU'RE SUPPOSED TO DO IS YOU'RE SUPPOSED TO RUN THE TEST OF MAYBE THREE DIFFERENT STANDARDS OVER AND OVER AGAIN OVER THE COURSE OF WHAT USUALLY WOULD TAKE THREE MONTHS. BUT AT THERANOS WE WERE RUNNING THEM IN A SHORTENED TIMEFRAME, SO WE WOULD JUST TRY AND GET THEM DONE AS SOON AS POSSIBLE. SO IT WOULD BE LIKE THREE DAYS TO A WEEK AND A HALF. SO WHAT I WOULD BE IN CHARGE OF DOING IS ESSENTIALLY WORKING IN SOMETIME SHIFTS TO BASICALLY RUN THOSE SAMPLES AND GENERATE THAT DATA OVER A COURSE OF TIME. SO IT'S PRETTY MUCH ALL THE SAME PROCESS. YOU HAVE A STANDARD, SOME SORT OF SAMPLE THAT YOU KNOW THE CONCENTRATION, YOU FILL THE CARTRIDGES, YOU PUT THE SAMPLE IN THERE, AND YOU RUN IT. IT'S JUST THE FOCUS IS DIFFERENT. SO FOR PRECISION, IT'S HOW MANY TIMES YOU RUN IT? WHAT DOES IT LOOK LIKE OVER A COURSE OF TIME? IF IT WAS FOR, YOU KNOW, THE DIFFERENT TYPES OF CONTAINERS, WHICH I DID FOR VITAMIN D, THAT'S THE SAME THING, YOU HAVE BASICALLY ONE CONTAINER, ONE TYPE OF COATING, ANOTHER TYPE OF CONTAINER WITH ANOTHER TYPE OF COATING, YOU RUN TWO CARTRIDGES AND YOU CROSS-COMPARE THEM. SO IT REALLY JUST DEPENDED ON THE ASSAY, DEPENDED ON WHAT WAS NEEDED REALLY IN THE COMPANY. SO THERE WAS A WHOLE RANGE OF DIFFERENT EXPERIMENTS.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO IT WOULD DEPEND ON THE STUDY. THE MAJORITY OF THE TIME AFTER IT WOULD BE RUN AND EVERYTHING, I WOULD PLACE IT INTO -- LIKE FOR PRECISION, FOR EXAMPLE, I WOULD PLACE IT INTO A SPREADSHEET, AND WE WOULD SAY THIS IS HOW MANY RUNS THAT WE DID OVER THIS COURSE OF TIME. AND IT WOULD BE -- AGAIN, THIS IS FOR RESEARCH AND DEVELOPMENT. WE WOULD PRESENT IN FRONT OF SHARADA IN THESE BIG GROUP MEETINGS ABOUT ALL OF THE THINGS THAT WE ACCOMPLISHED IN A PERIOD OF TIME, AND THEN REVIEW THE PRECISION DATA TO FIGURE OUT, OKAY, IS THIS SUFFICIENT ENOUGH? DO WE NEED TO RUN MORE CARTRIDGES? DO WE NEED TO -- IS IT FINE? ARE WE OKAY? CAN WE MOVE ON TO THE NEXT ASSAY? SO THAT IS ONE OF THE EXAMPLES OF WHAT I DO. IF IT WAS, SAY, A BLOOD COLLECTION CONTAINER WHERE I WAS COMPARING THEM, WHAT I WOULD DO IS INTERFACE ACTUALLY THE WHOLE SEPARATE TEAM, THAT WAS MICHAEL CHEN'S TEAM. AND SO I WOULD RUN IT -- YOU KNOW, THE BLOOD YOU GET FROM A LIHEP, L-I-H-E-P, CONTAINER OR EDTA, I'D STACK UP THE RESULTS FOR THEM, AND I WOULD CHART OUT THE GRAPHS OF, YOU KNOW, DO WE SEE THAT -- THE RESULTS FOR THE DIFFERENT TYPES OF BLOOD COLLECTION UNITS STACK UP TO WHAT OUR INTENDED OR WHAT OUR EXPECTED RESULTS WOULD BE? SO IT JUST REALLY DEPENDS ON WHAT WAS NEEDED, WHAT TYPE OF TEST WE WERE RUNNING, WHAT WE WERE LOOKING FOR.
MR. WADE: BUT THAT'S IMPORTANT WORK. YOU'RE GATHERING DATA AND THEN THAT DATA WOULD BE GIVEN TO OTHERS WHO WOULD ANALYZE IT AND INCORPORATE IT INTO A VALIDATION REPORT?
ERIKA CHEUNG: YES.
MR. WADE: OKAY. YOU TALKED ABOUT VITAMIN D. DO YOU KNOW WHEN THE VITAMIN D TEST WAS VALIDATED FOR USE IN THE CLIA LAB?
ERIKA CHEUNG: NO, I DON'T KNOW THE EXACT DATE.
MR. WADE: OKAY. IT'S BEEN A LONG TIME. WHY DON'T I JUST SHOW YOU A DOCUMENT AND SEE IF WE CAN GO THROUGH IT. COULD YOU LOOK AT 9412, PLEASE. ARE YOU FAMILIAR WITH THIS DOCUMENT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: THIS IS THE VITAMIN D VALIDATION DOCUMENT.
ERIKA CHEUNG: THE DATE ON THIS DOCUMENT -- THERE ISN'T AN EFFECTIVE DATE ON IT, BUT THE SIGNATURES HAVE DATES. IS IT THE SIGNATURE DATE YOU WANT OR THE --
ERIKA CHEUNG: SEPTEMBER 30TH OF 2013.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND DO YOU BELIEVE THAT THIS IS A TRUE AND ACCURATE COPY OF THE DOCUMENT THAT YOU WORKED WITH?
ERIKA CHEUNG: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9412 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: MS. CHEUNG, I'D LIKE YOU TO HELP US TAKE A LITTLE BIT OF A TOUR OF THIS DOCUMENT TO HELP US UNDERSTAND. THIS IS THE VALIDATION REPORT WE HAVE BEEN TALKING ABOUT; CORRECT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND LET'S START WITH THE FIRST PAGE. I SEE THAT THERE ARE -- AND JUST SO THE RECORD IS CLEAR, THIS IS THE ASSAY VALIDATION REPORT FOR THE EDISON DEVICE; RIGHT?
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND I SEE THAT THERE ARE SIGNATURES OF REVIEWERS ON THOSE PAGES. THESE ARE SOME NAMES THAT WE'VE TALKED ABOUT BEFORE?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: TO SAY WHO WROTE THEM, WHO REVIEWED THEM, WHO APPROVED THEM.
MR. WADE: AND SO THERE WAS A SERIOUS PROCESS BEFORE IT COULD BE OFFERED -- BEFORE A TEST COULD BE OFFERED TO PATIENTS; RIGHT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND THIS WAS THE CULMINATION OF THAT REVIEW, THIS SIGNATURE PAGE WHERE THEY DOCUMENTED -- EACH PERSON DOCUMENTED THEIR APPROVAL?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: TABLE 1 IS THE CALIBRATION DATA FOR THE EDISON 3.0'S.
ERIKA CHEUNG: YEAH, IT'S JUST A CALIBRATION DATA TABLE.
MR. WADE: OKAY. AND THIS DOCUMENT IS THE CALIBRATION OF THE DEVICE AT THE TIME THAT THE ASSAY WAS VALIDATED?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: "ANY TIP THAT RESULTED IN LESS THAN 150 RLU IS CONSIDERED A 'DARK' TIP. THESE AND OTHER OBVIOUS OUTLIERS, HIGHLIGHTED IN RED, WERE EXCLUDED FROM THE OVERALL MEAN AND RECOVERY CALCULATIONS. THE PERCENTAGE CV'S AND RECOVERY OF EACH LEVEL ARE WELL WITHIN ACCEPTABLE RANGES."
MR. WADE: OKAY. AND YOU TALKED A LITTLE BIT ON DIRECT ABOUT OUTLIER REMOVAL. DO YOU RECALL THAT?
ERIKA CHEUNG: YES.
MR. WADE: AND THE TEXT THAT YOU JUST IDENTIFIED IS DOCUMENTING THAT THERE WAS OUTLIER REMOVAL IN CONNECTION WITH THE DEVICE CALIBRATION; RIGHT?
ERIKA CHEUNG: FOR THIS PARTICULAR TABLE, YES.
MR. WADE: YEAH. LET'S GO TO PAGE 1312. AND IF WE CAN LOOK AT -- WELL, CAN YOU TELL US WHAT IS TABLE 2?
ERIKA CHEUNG: TABLE 2 IS ANOTHER CALIBRATION DATA SET FOR ANOTHER EDISON DEVICE.
MR. WADE: OKAY. CAN WE LOOK AT THE LANGUAGE IN THE TOP THERE. AND FOR THIS ONE IT SAYS NO POINTS WERE EXCLUDED FROM THIS DATA SET; RIGHT? IS THAT CORRECT?
ERIKA CHEUNG: THAT IS CORRECT.
ERIKA CHEUNG: FOR THE CALIBRATION, NO.
ERIKA CHEUNG: IS THAT PAGE 12?
ERIKA CHEUNG: SORRY, 1314.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND IN THIS INSTANCE AGAIN THERE WERE REMOVALS OF OUTLIERS, AND THAT'S DOCUMENTED HERE IN THE REPORT?
ERIKA CHEUNG: YES.
MR. WADE: AND JUST SO WE UNDERSTAND THIS PROCESS, THESE VALIDATION DOCUMENTS ARE MAINTAINED IN THE FILES OF THE LAB?
ERIKA CHEUNG: IN THE RESEARCH AND DEVELOPMENT LAB.
ERIKA CHEUNG: THIS IS THE ASSAY VALIDATION REPORT, YES.
MR. WADE: RIGHT. THIS IS THE DOCUMENT THAT IS PREPARED WITHIN THE CLIA LAB AND SIGNED BY DR. ROSENDORFF BEFORE A TEST CAN BE OFFERED WITHIN THE CLIA LAB; RIGHT?
ERIKA CHEUNG: YES, BUT THE MAJORITY OF THESE DOCUMENTS EXISTED IN THE RESEARCH AND DEVELOPMENT LAB IN TERMS OF THE DRIVES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: OF THE SAME SET?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: I DON'T KNOW.
ERIKA CHEUNG: THE ELISA TEAM.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: THE HEADING.
ERIKA CHEUNG: YES.
MR. WADE: AND IT SAYS THAT THEY'RE HIGHLIGHTED IN RED, ALTHOUGH WE DON'T HAVE A COLOR COPY HERE.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: THAT'S IN THE BINDER?
ERIKA CHEUNG: THIS DOCUMENT IS THE ELISA ASSAY VALIDATION REPORT FOR TSH ON THE 3.X THERANOS SYSTEM.
ERIKA CHEUNG: THESE ARE THE -- THESE WERE DONE IN THE RESEARCH AND DEVELOPMENT LAB AND THE ASSAY DEVELOPMENT -- THIS WAS THE ASSAY VALIDATION REPORT THAT WAS DONE WITHIN THE RESEARCH AND DEVELOPMENT LAB.
BY DR. ROSENDORFF THAT THE TEST WAS SAFE FOR PATIENT USE WITHIN THE CLIA LAB; CORRECT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES, IN THE --
ERIKA CHEUNG: -- IN THE CLIA LAB, YES.
MR. WADE: AND THIS IS A DOCUMENT THAT YOU WERE FAMILIAR WITH AT THE TIME THAT YOU WERE WORKING WITHIN THE CLIA LAB?
ERIKA CHEUNG: YES, ROUGHLY.
ERIKA CHEUNG: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT MAY BE ADMITTED AND PUBLISHED.
(DEFENDANT'S EXHIBIT 9368 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: AND JUST CALLING YOUR ATTENTION TO THE FIRST PAGE OF 9368. HERE AGAIN THIS IS A REPORT THAT IS SIGNED OFF ON BY FOUR PEOPLE?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO MICHELLE JOHNSON WAS A RESEARCH ASSOCIATE IN THE RESEARCH AND DEVELOPMENT LAB FOR ELISA; SHARADA SIVARAMAN, WHO WAS THE IMMUNOASSAY TEAM LEADER FOR THE ELISA; DANIEL YOUNG, WHO WAS THE VICE PRESIDENT OF THERANOS; AND THEN ADAM ROSENDORFF, WHO WAS A LABORATORY DIRECTOR OF THE CLIA LAB.
MR. WADE: OKAY. AND WE WON'T GO THROUGH THE SPECIFICS OF EACH ONE. I'LL CALL YOUR ATTENTION NEXT TO A NEW DOCUMENT, 9381.
ERIKA CHEUNG: 9381. I SEE.
ERIKA CHEUNG: SO THIS DOCUMENT IS THE TOTAL T4 ELISA ASSAY VALIDATION REPORT ON THE EDISON 3.5 THERANOS SYSTEM.
ERIKA CHEUNG: IN THE CLIA LAB, YES.
ERIKA CHEUNG: NO, I WAS NOT FAMILIAR WITH THIS VALIDATION REPORT.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SHE.
ERIKA CHEUNG: YEAH, SHE WAS A SCIENTIST ON THE ELISA TEAM.
ERIKA CHEUNG: THIS DOCUMENT IS THE ASSAY VALIDATION REPORT FOR THE 3.X THERANOS SYSTEM FOR TPSA, FOR TOTAL PROSTATE --
MR. WADE: AND THIS WAS ONE OF THE -- TPSA WAS ONE OF THE ASSAYS THAT YOU WORKED ON IN THE CLIA LAB?
ERIKA CHEUNG: YES.
MR. WADE: AND WERE YOU FAMILIAR WITH THIS DOCUMENT AT THE TIME THAT YOU WERE WORKING AT THE COMPANY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9387 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: HERE AGAIN THERE IS SIGNOFF BY MULTIPLE PEOPLE TO DOCUMENT THAT THEY HAVE APPROVED THIS ASSAY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND AGAIN, THIS IS SOMETHING THAT IS CERTIFYING THAT THE TEST IS READY FOR USE IN THE CLIA LAB?
ERIKA CHEUNG: YES.
MR. WADE: AND I THINK WE TALKED ABOUT, MS. CHEUNG, THAT AFTER YOU HAD THE VALIDATION REPORTS, THERE WAS A NEED TO CREATE SOP'S; IS THAT RIGHT?
ERIKA CHEUNG: YES, THAT IS CORRECT.
MR. WADE: OKAY. LET'S LOOK AT ONE OF THOSE. COULD YOU LOOK AT 9925. DO YOU HAVE THAT IN FRONT OF YOU?
ERIKA CHEUNG: YES, I DO.
ERIKA CHEUNG: THIS IS THE STANDARD OPERATING PROCEDURE IN THE CLIA LABORATORY FOR THE VITAMIN D TEST ON THE EDISON 3.5 THERANOS SYSTEM.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. BOSTIC: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(DEFENDANT'S EXHIBIT 9925 WAS RECEIVED IN EVIDENCE.)
BY MR. WADE:
MR. WADE: NOW, THIS IS A NEW DOCUMENT SO MAYBE WE'LL GO -- SPEND A LITTLE TIME GOING THROUGH THIS SO WE CAN UNDERSTAND WHAT THIS DOCUMENT DOES. LET'S START ON PAGE 1. IS THIS DOCUMENT REVIEWED AND APPROVED BY A SIMILAR GROUP OF PEOPLE BEFORE IT'S REVIEWED IN THE LAB?
ERIKA CHEUNG: YES.
MR. WADE: AND WHO ARE THE PEOPLE WHO REVIEWED AND APPROVED THE STANDARD OPERATING PROCEDURE ASSAY?
ERIKA CHEUNG: SO MICHELLE JOHNSON, WHO WAS ON THE ELISA TEAM, SHE WAS AN IMMUNOASSAY RESEARCH ASSOCIATE; SURAJ SAKSENA, WHO WAS A TEAM LEADER ON THE BINDERS TEAM; DANIEL YOUNG, WHO WAS THE VICE PRESIDENT OF THE COMPANY; AND ADAM ROSENDORFF, WHO WAS THE LAB DIRECTOR.
MR. WADE: AND SO THEY'RE COMING UP WITH A PROTOCOL FOR YOU TO RUN THE TEST WITHIN THE LAB; IS THAT RIGHT?
ERIKA CHEUNG: THAT IS CORRECT.
ERIKA CHEUNG: SO INITIALLY WHEN I HAD STARTED PROCESSING PATIENT SAMPLES I HADN'T SEEN THESE DOCUMENTS ACTUALLY AS A CLINICAL LAB ASSOCIATE AND WHILE WORKING IN R&D. SO IT WASN'T UNTIL LATER ON I HAD ACTUALLY EVEN VIEWED THESE. SO PROBABLY IN LIKE DECEMBER OR JANUARY, AROUND THAT TIME.
ERIKA CHEUNG: BUT ESSENTIALLY THIS WAS THE WHAT IS CALLED LIKE THE RECIPE BOOK OF HOW YOU WOULD RUN A PATIENT SAMPLE. SO TELL US FOR THE QUALITY CONTROLS, HOW DO YOU RUN THE QUALITY CONTROLS? WHEN YOU ARE RUNNING THE PATIENT SAMPLE, HOW DO YOU RUN THE PATIENT SAMPLE? AND THIS DOCUMENT WAS ITERATIVE BECAUSE WE WERE USING DIFFERENT TYPES OF TESTING METHODOLOGY OVER A COURSE OF TIME. SO WE WOULD GO AND TURN TO THIS DOCUMENT TO BASICALLY FIGURE OUT HOW DO WE CONDUCT OUR RESPONSIBILITIES AS LAB ASSOCIATES. AND THEN ALSO IF THERE WERE UPDATES NEEDED BECAUSE THERE WAS ACTUALLY DIFFERENCES BETWEEN WHAT THIS DOCUMENT SAID AND WHAT WE WERE ACTUALLY DOING, THEN WE WOULD GO BACK, AND WE WOULD NOTIFY PEOPLE THAT THERE WAS DISCREPANCIES BETWEEN THEM.
ERIKA CHEUNG: EXACTLY.
MR. WADE: AND SO IF YOU NOTICED THAT THERE WAS SOMETHING THAT NEEDED TO DEVIATE, YOU WOULD TAKE, YOU WOULD TAKE THAT TO YOUR SUPERVISORS AND MAKE SURE IT WAS OKAY TO DEVIATE?
ERIKA CHEUNG: YES. AND EVEN SIMPLE THINGS LIKE INITIALLY WE WERE RUNNING THE TEST ON THREE SEPARATE EDISON DEVICES, AND WE WERE GOING TO DO ONE PATIENT, AND THEN THAT PROTOCOL CHANGED TO WHERE IT WAS AGGREGATIVE, SO THERE WERE SIX REACTION TIPS ON ONE CARTRIDGE. SO THEN WE HAD TO CREATE A WHOLE NEW PROTOCOL WHEN THAT TRANSITION HAPPENED.
MR. WADE: OKAY. AND WAS THAT THE PROTOCOL -- I KNOW DR. PANDORI, IN AN EMAIL YOU TALKED ABOUT ON DIRECT, HE WOULD LIKE YOU TO PROVIDE FEEDBACK ON THE STANDARD OPERATING PROCEDURE. WAS THAT PART OF THAT PROCESS OR A DIFFERENT PROCESS?
ERIKA CHEUNG: IT WAS BASICALLY TO REVIEW ALL OF THESE SOP'S THAT WE HAD TO SEE, YOU KNOW, WHAT THE SOP STATUS WAS AS OF RIGHT NOW AND WHAT IT WAS WE WERE ACTUALLY DOING IN THE CLINICAL LAB. SO IT WAS IN REFERENCE TO A WHOLE ARRAY -- THERE WERE DIFFERENT TYPES OF METHODOLOGIES USED DEPENDING ON WHAT TYPE OF TEST IT WAS. IT WASN'T NECESSARILY STANDARDIZED ACROSS THE DIFFERENT ASSAYS. SO IT WAS JUST REVIEWING EACH OF THEM TO SEE.
MR. WADE: RIGHT. YOU WOULD HAVE TO GO THROUGH EACH DOCUMENT BECAUSE THERE MIGHT BE ASSAY SPECIFIC STEPS THAT NEED TO BE TAKEN?
ERIKA CHEUNG: YES, AND THERE WERE TECHNICAL DIFFERENCES, METHODOLOGY DIFFERENCES THAT WERE BEING UTILIZED FOR DIFFERENT TYPES OF TESTS.
MR. WADE: AND WITHIN THE HIGH COMPLEXITY LAB, YOU WOULD HAVE TO GET THAT APPROVED BY THE PEOPLE WHO ARE RESPONSIBLE FOR APPROVING THOSE TYPES OF CHANGES?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. LET'S WALK THROUGH IT A LITTLE BIT. IF YOU CAN LOOK AT PAGE 4 OF THE POLICY, WHICH IS BATES LABELLED ENDING 788. DO YOU HAVE THAT IN FRONT OF YOU?
ERIKA CHEUNG: YES. YES.
MR. WADE: OKAY. AND THE FIRST PAGE TALKS ABOUT -- GIVES SOME GENERAL OVERVIEWS AND RESPONSIBILITIES; IS THAT FAIR?
ERIKA CHEUNG: THAT'S FAIR.
MR. WADE: AND IF WE CAN BLOW UP THE FULL -- THE PARAGRAPH 4. THESE ARE THE RESPONSIBILITIES OF THE OPERATORS; IS THAT RIGHT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: LET'S GO TO THE NEXT PAGE. THESE ARE -- THESE JUST INCORPORATE RELATED DOCUMENTS, SAFETY ITEMS, AND MATERIALS AND EQUIPMENT THAT ARE USED?
ERIKA CHEUNG: YES.
MR. WADE: OKAY. WE'LL GO TO THE NEXT PAGE, PAGE 6 OF 21 OF THE POLICY. DO YOU SEE ON THE BOTTOM THERE IT TALKS ABOUT THE THERANOS SYSTEM?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: SO THIS IS IN REFERENCE TO THE CONNECTION BETWEEN THE ASSAY VALIDATION DOCUMENT AND THIS PARTICULAR STANDARD OPERATING PLAN.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND LET'S GO UP TO PAGE 7, AND LET'S LOOK AT THE TOP THERE AT 8.1.2. DO YOU SEE UP AT THE TOP THERE THIS TALKS ABOUT HOW QUALITY TESTING NEEDS TO HAPPEN DAILY?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. AND YOU TALKED ABOUT QC AND SOME OF THE RESULTS THAT WEREN'T SATISFACTORY ON YOUR DIRECT. DO YOU RECALL THAT? AND I JUST WANT TO TALK A LITTLE BIT ABOUT THAT AND MAKE SURE THAT I UNDERSTAND IT CORRECTLY.
ERIKA CHEUNG: OKAY.
ERIKA CHEUNG: WHAT IS THE MATERIAL THAT IS TESTED?
ERIKA CHEUNG: SO TYPICALLY IT WILL BE SOME SORT OF SOLUTION AND THE ACTUAL ANALYTE OF INTEREST. FOR EXAMPLE, SO IT WILL BE VITAMIN D THAT WILL BE PLACED IN SOME SORT OF SOLUTION. SO SOMETIMES THAT SOLUTION COULD BE SERA, LIKE SERA FROM HUMAN BLOOD. IT COULD BE ANOTHER TYPE OF MATERIAL THAT IS SHOWN TO HAVE EQUIVALENT MATRIX TO WHATEVER THE MATRIX WOULD BE SIMILAR EQUIVALENT TO THAT YOU WOULD FIND IN A FINGERSTICK SAMPLE. AND THAT'S WHAT THE QUALITY CONTROL MATERIAL IS MADE OF. IT REALLY DEPENDS ON THE TEST AS WELL, WHAT THEY DECIDE TO DEVELOP IT FROM.
ERIKA CHEUNG: UM, IT'S NOT HUMAN BLOOD, LIKE FULL BLOOD?
MR. WADE: MY QUESTION IS THE QUALITY CONTROL MATERIAL THAT YOU'RE TESTING IS NOT HUMAN BLOOD THAT IS BEING TESTED?
ERIKA CHEUNG: NO. SOMETIMES IT DOES HAVE HUMAN BLOOD IN IT, BUT IT'S NOT LIKE THE SAME AS A BLOOD SAMPLE.
MR. WADE: AND IT'S NOT A PATIENT SAMPLE. IT'S NOT WHEN THESE QC FAILURES WERE HAPPENING, IT WASN'T ON A SAMPLE THAT WAS A PATIENT SAMPLE; RIGHT?
ERIKA CHEUNG: CORRECT.
MR. WADE: OKAY. AND THE PURPOSE OF THE QC WAS SO THAT WHAT YOU WOULD -- YOU WOULD MAKE SURE THE TEST PASSED AND ONLY THEN COULD YOU DO THE PATIENT SAMPLE; RIGHT?
ERIKA CHEUNG: CORRECT.
MR. WADE: AND THIS SOP HERE ACTUALLY REQUIRED THE LABORATORY ASSOCIATES TO RUN THAT ON A DAILY BASIS?
ERIKA CHEUNG: CORRECT.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. ON THE QUALITY CONTROL POINT, WE TALKED ABOUT SOME OF THE DIFFERENT PERSONNEL WITHIN THE LAB?
ERIKA CHEUNG: UH-HUH.
MR. WADE: AND I THINK THERE WAS, THERE WAS A PERSON WHO IS IDENTIFIED IN SOME OF THE DOCUMENTS, LANGLY GEE?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: LANGLY GEE WAS THE QUALITY CONTROL MANAGER WHO CAME IN AROUND EITHER LATE DECEMBER OR EARLY JANUARY OF 2013, 2014.
ERIKA CHEUNG: OKAY. HE WAS IN CHARGE OF THE QUALITY CONTROL MANAGEMENT OF THE DIFFERENT TYPES OF MEDICAL DEVICES THAT WE UTILIZED IN THE LAB AT THERANOS.
MR. WADE: AND WHEN YOU SAY "IN CHARGE," DO YOU HAVE AN UNDERSTANDING OF WHAT HE DID ON A DAY-TO-DAY BASIS?
ERIKA CHEUNG: I DON'T KNOW WHAT HE DID ON A DAY-TO-DAY BASIS.
ERIKA CHEUNG: I WOULD INTERACT WITH HIM WHEN I WOULD RUN THE QUALITY CONTROL DATA AND HE NEEDED TO AGGREGATE IT OVER A COURSE OF TIME. SO VERY SPECIFICALLY, SAY WITH THE EDISON DEVICES, WE HAD A SPREADSHEET BECAUSE IT WASN'T AUTOMATED YET IN TERMS OF CAPTURING THAT DATA, SO ALL OF THE INFORMATION THAT WE WOULD COLLECT AS LAB ASSOCIATES, WE WOULD PUT IT INTO THIS EXCEL DOCUMENT. SO ONCE IT HAD BEEN ESTABLISHED WHETHER IT WAS FAILING, OR WHATEVER ELSE, WE WOULD SEND THAT DOCUMENT OVER TO LANGLY GEE AND THE CLINICAL LAB SCIENTISTS.
MR. WADE: OKAY. AND DO YOU KNOW WHETHER THERE WERE CERTAIN QUALIFICATIONS THAT WERE REQUIRED WITHIN A CLIA LAB FOR SOMEONE TO SERVE IN THAT POSITION?
ERIKA CHEUNG: I DON'T KNOW.
MR. WADE: OKAY. IF I COULD TURN YOU BACK -- SORRY ABOUT THAT SEGUE, MS. CHEUNG. BUT IF I COULD TURN YOU BACK TO THIS SOP 9925. WE WERE TALKING ABOUT QUALITY AND CONTROL, AND I'M GOING TO SHIFT TO CALIBRATION, WHICH IS ON PAGE 10.
ERIKA CHEUNG: PAGE 10 OF THIS PAGE?
ERIKA CHEUNG: OR OF THIS SET?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: -- WITHIN THIS DOCUMENT?
ERIKA CHEUNG: SO CALIBRATION INFORMATION -- SO YOU HAVE TO CALIBRATE THE DEVICE BEFORE YOU CAN USE IT. SO ESSENTIALLY AT THERANOS IN ORDER TO CALIBRATE THE DEVICE, YOU HAD TO RUN A SERIES OF STANDARDS. SO YOU CAN THINK OF CALIBRATION KIND OF LIKE A SCALE. SO SOMETIMES THE SCALE IS A LITTLE ASKEW AND SO YOU PUT A 5 POUND WEIGHT ON THERE AND MAKE SURE THAT IT IS SYNCED UP OR A 10 POUND WEIGHT AND YOU KIND OF ADJUST AND MAKE SURE THAT EVERYTHING IS SORT OF HITTING THE MARK. SO THIS WAS ESSENTIALLY NOTIFYING OF THAT PROCESS, LIKE HOW MANY STANDARDS DO WE HAVE? HOW MANY TIMES DO WE RUN IT? AND THEN FROM THERE YOU WOULD GET A CALIBRATION CURVE ASSOCIATED WITH RUNNING ALL OF THESE DIFFERENT STANDARDS, AND THAT WAS CALLED DEXTER. IT HAD A SPECIFIC NAME. SO THE DEXTER WOULD PROVIDE VARIOUS CALIBRATION CURVES THAT WOULD ASSOCIATE BASICALLY THESE DIFFERENT STANDARDS THAT WE RAN WITH THIS CALIBRATION CURVE IN ORDER TO HELP GENERATE THE ACTUAL VALUE OF THE LIGHT EMITTANCE TO THE ACTUAL CONCENTRATION VALUE OR THE POSITIVE OR NEGATIVE VALUE DEPENDING ON WHAT KIND OF TEST IT WAS.
MR. WADE: OKAY. AND DO YOU SEE WITHIN THAT SECTION SOME OF THE STEPS THAT SHOULD BE TAKEN FOR THAT ON A ROUTINE BASIS ARE SET FORTH ON SECTION 11 HERE?
ERIKA CHEUNG: YES.
MR. WADE: AND DO YOU SEE 11.1.2 CORRECTIONS? DO YOU SEE THE REFERENCE THERE, "THE EXCEL FILE WILL AUTOMATICALLY CALCULATE THIS RESULT IN THE BIAS CORRECTION"?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: BIAS CORRECTION WAS BASICALLY A CALCULATION THAT WAS DERIVED FROM THE DEXTER. SO IT WAS SOMETHING THAT WE APPLIED IN ORDER TO ACCOMMODATE FOR ANY DIFFERENCES THAT MAY HAVE BEEN ATTRIBUTED FROM DEVICE TO DEVICE.
ERIKA CHEUNG: BECAUSE ESSENTIALLY THERE MIGHT BE MINOR DIFFERENCES FROM EACH MANUFACTURED DEVICE THAT YOU HAVE, THAT'S WHY YOU RUN A CALIBRATION TO SORT OF ACCOUNT FOR THOSE SUBTLE DIFFERENCES BETWEEN THE HARDWARE THAT YOU MIGHT HAVE OR OTHER CONDITIONS.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: OKAY. LIKE I THINK WE TALKED ABOUT IN CONNECTION WITH VITAMIN D THERE WERE CERTAIN NUMBERS THAT WOULD COME UP. SOMETIMES YOU WOULD HAVE TO TWEAK THEM A LITTLE BIT TO BE AN APPLES TO APPLES COMPARISON?
ERIKA CHEUNG: IN REGARDS -- IN WHAT SENSE?
ERIKA CHEUNG: IN REGARD TO CALIBRATION.
MR. WADE: YEAH. AND AGAIN, ON THIS PAGE, JUST QUICKLY -- I THINK WE'VE COVERED THIS -- BUT HERE AGAIN IT SET FORTH SPECIFIC PROCEDURES ON SECTION 12 RELATING TO THE QUALITY CONTROL TESTING?
ERIKA CHEUNG: YES.
MR. WADE: OKAY. LET'S TURN TO -- THAT QUALITY CONTROL TESTING CARRIES ON FOR A COUPLE OF PAGES. DO YOU SEE THAT?
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND IF WE GO TO PAGE 12. AND THOSE EXPECTED RANGES, THOSE WERE WHAT YOU USED TO ASSESS WHETHER OR NOT SOMETHING PASSED QC; IS THAT RIGHT?
ERIKA CHEUNG: UM, WHAT WAS ACTUALLY DONE WAS THAT THERE WERE NEW QC RANGES AND STANDARDS THAT WERE ESTABLISHED EVERY TIME WE HAD TO RECALIBRATE. SO THIS -- THESE WEREN'T UTILIZED BECAUSE WE HAD TO GENERATE NEW QC VALUES EFFECTIVELY AFTER WE RECALIBRATED THE SYSTEM.
ERIKA CHEUNG: NO. WE WOULD JUST PUT THE QC RANGE VALUES IN A DIFFERENT DOCUMENT TO ASSOCIATE WHAT THE NEW QC RANGES WERE FOR WHATEVER SUBSET, BECAUSE IT WAS ACTUALLY DYNAMIC INFORMATION. IT'S NOT FIXED INFORMATION FOR QC RANGES.
MR. WADE: FAIR ENOUGH. AND THEN YOU WOULD RUN, CONTINUE TO RUN THE QC OFF OF THAT DYNAMIC INFORMATION?
ERIKA CHEUNG: YES.
MR. WADE: OKAY. LET'S GO TO PAGE 12. AND THERE'S A PROCEDURE THERE THAT SET FORTH WHAT YOU DO WHEN A QC TEST FAILS; RIGHT?
ERIKA CHEUNG: CORRECT.
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: CAN I TAKE A MOMENT TO READ THEM.
(PAUSE IN PROCEEDINGS.)
ERIKA CHEUNG: YES.
BY MR. WADE:
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES. WE PROBABLY ALSO ADDED IN HERE THAT YOU HAD TO RECALIBRATE THE WHOLE SYSTEM AND RECALIBRATE WHAT THE QC VALUES WERE AT A GIVEN POINT IN TIME BECAUSE THE SET OF READERS KEPT FAILING SO OFTEN. SO IT WAS LIKE ONCE YOU TROUBLESHOOT PAST THESE TWO SEPARATE LINE ITEMS, BECAUSE THEY WERE HAPPENING, WE WOULD CORRECT FOR THESE TWO THINGS. IT WAS LIKE, WELL, WHAT IS THE NEXT THING? WE HAVE TO RECALIBRATE THE WHOLE SYSTEM. THAT'S NOT INCLUDED HERE, BUT THAT'S SOMETHING THAT WE HAD TO DO AS A FINAL STEP.
ERIKA CHEUNG: OH, YEAH.
ERIKA CHEUNG: THAT'S ALSO JUST WHAT YOU DO WITH LAB TESTS IS YOU RECALIBRATE.
MR. WADE: OKAY. AND THAT'S A PRETTY BIG COMMITMENT OF TIME; RIGHT? IT TAKES A LONG TIME TO RECALIBRATE?
ERIKA CHEUNG: YEAH. DEPENDING ON THE ASSAY, IT CAN BE ANYWHERE FROM LIKE 23 HOURS OF WORK TO LIKE UPWARDS OF 83 HOURS OF WORK.
MR. WADE: UH-HUH. BUT THAT WAS THE PROCEDURE THAT THERANOS PUT IN PLACE AS THE NEXT STEP IN THIS PROCESS?
ERIKA CHEUNG: YEAH.
ERIKA CHEUNG: YEAH, I DO.
ERIKA CHEUNG: SO THIS IS THE PROFICIENCY TESTING STANDARD OPERATING PROCEDURE FOR THE EDISON 3.5.
ERIKA CHEUNG: NO, I DON'T REMEMBER THIS DOCUMENT.
ERIKA CHEUNG: YES.
ERIKA CHEUNG: YES.
MR. WADE: AND MANY OF THE THINGS THAT A CLIA LAB NEEDS TO DO IS THAT THEY CREATED A PROCEDURE TO DO THAT?
ERIKA CHEUNG: YES.
JUDGE DAVILA: MR. WADE, IS THIS A GOOD TIME TO BREAK FOR THE DAY?
MR. WADE: YEAH, I THINK IT PROBABLY IS A GOOD TIME. WE CAN RESTART ON FRIDAY AND TRY TO FINISH UP QUICKLY.
JUDGE DAVILA: LET'S DO THAT THEN. LADIES AND GENTLEMEN, WE'LL TAKE OUR RECESS. PLEASE REMEMBER WE'RE NOT IN SESSION TOMORROW, BUT WE WILL BE IN SESSION FRIDAY MORNING. I HOPE WE CAN START AT 9:00 O'CLOCK. SO IF YOU COULD COLLECT YOURSELVES ACCORDINGLY, I'D BE GRATEFUL. LET ME ONCE AGAIN REMIND YOU OF THE ADMONITION. YOU STILL ARE UNDER THAT ADMONITION NOT TO LISTEN TO, SEE, HEAR, READ OR IN ANY WAY DO ANY RESEARCH ABOUT THIS CASE, AND PLEASE DO NOT TALK ABOUT THE CASE, AND DO NOT LET ANYONE TALK TO YOU ABOUT ANYTHING INVOLVED WITH THIS CASE. SHOULD SOMEONE CONTACT YOU OR TRY TO COMMUNICATE WITH YOU, YOU SHOULD BRING THAT TO MY ATTENTION THROUGH MS. KRATZMANN, AND I'LL TAKE APPROPRIATE ACTION. UNTIL THEN, THANK YOU VERY MUCH. HAVE A GOOD EVENING. WE'LL SEE YOU FRIDAY MORNING. THANK YOU. MS. CHEUNG, I'LL ASK YOU TO COME BACK FRIDAY MORNING AS WELL, PLEASE. THANK YOU.
(JURY OUT AT 3:00 P.M.)
JUDGE DAVILA: PLEASE BE SEATED. THANK YOU. ALL RIGHT. THE RECORD SHOULD REFLECT THAT OUR JURY HAS LEFT FOR THE DAY. THE WITNESS HAS LEFT THE COURTROOM. BEFORE WE RECESS, COUNSEL, ANYTHING TO TAKE UP BEFORE WE RECESS TODAY?
MR. SCHENK: NO, YOUR HONOR.
MR. WADE: YOUR HONOR, JUST ONE POINT OF CLARIFICATION. I ASSUME WHILE THE WITNESS IS ON CROSS THERE WILL BE NO CONTACT WITH THE WITNESS?
JUDGE DAVILA: I THINK THAT'S WHAT WE DISCUSSED IN OUR IN LIMINE AND PRETRIAL CONFERENCE. I THINK ALL COUNSEL ARE GOING TO ADHERE TO THAT. RIGHT.
MR. BOSTIC: YES, YOUR HONOR.
JUDGE DAVILA: OKAY. THANK YOU.
COURT CLERK: COURT IS ADJOURNED.
(COURT ADJOURNED AT 3:01 P.M.)