Skip to content
Elizabeth Holmes- Case Archive
Federal Criminal TrialtranscripttranscriptAdam Rosendorff — Cross (Continued) - Day 13 - Federal Criminal TrialThe morning session opened with Adam Rosendorff being resworn before the defense resumed cross-examination.
John C. BosticRobert S. LeachKatherine TrefzLance A. WadeEdward J. DavilaAdam RosendorffJudge DavilaAdam RosendorffMr. WadeMs. TrefzMr. BosticCourt ClerkMr. Leachproceduralcross
Federal Criminal Trial/Day 13/September 29, 2021
2 pages·2 witnesses·3,584 lines
The morning session opened with Adam Rosendorff being resworn before the defense resumed cross-examination.
← Day 12
Day 14 →
Cross

Adam Rosendorff — Cross (Continued)

Lance A. Wade Adam Rosendorff
2,559 lines
Proceedings
ProceduralMorning Session Opening and Rosendorff ReswearingLine 1
CrossAdam Rosendorff — CrossLine 25
ProceduralProc.Morning Session Opening and Rosendorff Reswearing
1

SAN JOSE, CALIFORNIA SEPTEMBER 29, 2021 P R O C E E D I N G S

2

(COURT CONVENED AT 9:03 A.M.)

3

(JURY IN AT 9:03 A.M.)

4

JUDGE DAVILA: THANK YOU. PLEASE BE SEATED. WE'RE BACK ON THE RECORD IN UNITED STATES VERSUS HOLMES. ALL COUNSEL IS PRESENT. MS. HOLMES IS PRESENT. OUR JURY AND ALTERNATES ARE PRESENT. GOOD MORNING, LADIES AND GENTLEMEN. BEFORE WE BEGIN, LET ME ASK OUR JURORS WHETHER OR NOT, IN THE RECESS WHETHER OR NOT THEY HAD OCCASION TO EITHER SEE, WATCH, DISCUSS ANYTHING WITH ANYONE ABOUT ANYTHING TO DO WITH THIS CASE. IF SO, COULD YOU PLEASE RAISE YOUR HAND SO WE CAN TALK ABOUT THAT? I SEE NO HANDS. GREAT. THANK YOU VERY MUCH. LET'S SEE. DO WE HAVE THE WITNESS HERE? I THINK HE'S BEING SUMMONED. DR. ROSENDORFF, GOOD MORNING.

5

ADAM ROSENDORFF: GOOD MORNING.

6

JUDGE DAVILA: IF YOU COULD RESUME THE STAND AND MAKE YOURSELF COMFORTABLE AGAIN.

8

JUDGE DAVILA: WHEN YOU ARE COMFORTABLE, I WOULD JUST ASK YOU TO STATE YOUR NAME AGAIN, AND I REMIND YOU THAT YOU'RE STILL UNDER OATH.

10

(GOVERNMENT'S WITNESS, ADAM ROSENDORFF, WAS RESWORN.)

11

ADAM ROSENDORFF: MY NAME IS ADAM ROSENDORFF.

12

JUDGE DAVILA: THANK YOU. MR. WADE, DO YOU HAVE ADDITIONAL QUESTIONS?

13

MR. WADE: I DO, YOUR HONOR.

14

JUDGE DAVILA: LET'S PROCEED. LADIES AND GENTLEMEN, WE'LL TAKE A BREAK I THINK A LITTLE AFTER 11:00, BEFORE 11:30 IF THAT'S CONVENIENT, AND I THINK WE'RE GOING TO GO UNTIL 4:00 O'CLOCK TODAY. YOU HAVE AN ENGAGEMENT.

15

ADAM ROSENDORFF: YES, CHILDCARE.

16

JUDGE DAVILA: RIGHT. I'VE TALKED WITH COUNSEL AND, OF COURSE, WE'RE GOING TO ALLOW THAT TO HAPPEN SO YOU CAN TAKE CARE OF YOUR NEEDS AND THEN WE'LL ADJUST ACCORDINGLY.

17

ADAM ROSENDORFF: THANK YOU. I APPRECIATE THAT.

18

MR. WADE: AND I'LL TRY TO KEEP AN EYE ON THE TIME, I HOPE, FOR THE BREAK. IF YOU SEE ME LOOKING AT MY WATCH, IT'S NOT BECAUSE I'M BOARD BEING HERE.

19

JUDGE DAVILA: ALL RIGHT. THANK YOU. /// /// ///

CrossCross Adam Rosendorff Lance A. Wade
20

CROSS-EXAMINATION (RESUMED) BY MR. WADE:

21

MR. WADE: GOOD MORNING, DR. ROSENDORFF.

22

ADAM ROSENDORFF: GOOD MORNING.

23

MR. WADE: I'D LIKE TO COME BACK AND ASK YOU SOME QUESTIONS RELATING TO SOME MATTERS THAT YOU DISCUSSED ON DIRECT EXAMINATION. OKAY?

25

MR. WADE: I'D LIKE TO START WITH THE 2013 AUDIT BY THE CALIFORNIA DEPARTMENT OF HEALTH. DO YOU RECALL GIVING SOME GENERAL TESTIMONY WITH RESPECT TO THAT?

27

MR. WADE: AND BEING A CERTIFIED LABORATORY SUBJECTS THE LABORATORY TO AUDITS BY REGULATORS LIKE THE CDPH AND THE CMS ON A REGULAR BASIS; IS THAT RIGHT?

29

MR. WADE: AND I THINK YOU DISCUSSED THAT DECEMBER 13TH AUDIT YESTERDAY.

31

MR. WADE: THAT WAS THE FIRST AUDIT IN THE TIME PERIOD THAT YOU WERE THE LAB DIRECTOR AT THERANOS?

33

MR. WADE: AND THE GOVERNMENT --

34

ADAM ROSENDORFF: WELL, IT WAS BY NEW YORK STATE. I WASN'T THE LAB DIRECTOR AT THE TIME, BUT I WAS EMPLOYED BY THE COMPANY.

35

MR. WADE: OKAY. SO IN ADDITION TO THE AUDITS THAT ARE DONE BY CMS, WHICH IS THE FEDERAL REGULATOR, THERE ARE SOMETIMES AUDITS THAT ARE DONE BY STATES FOR THEIR OWN ACCREDITATION PURPOSES; RIGHT?

36

ADAM ROSENDORFF: NEW YORK STATE.

37

MR. WADE: AND NEW YORK STATE DOES ITS OWN AUDIT WHERE IT COMES IN AND LOOKS AT THE LAB AND MAKES SURE THAT IT'S CERTIFIED IN A MANNER THAT COMPLIES WITH ITS REQUIREMENTS UNDER NEW YORK STATE LAW; IS THAT RIGHT?

39

MR. WADE: AND IN THIS INSTANCE, THERE WAS ALSO AN AUDIT THAT WAS DONE BY THE CALIFORNIA DEPARTMENT OF HEALTH; RIGHT?

41

MR. WADE: AND THAT WAS IN DECEMBER OF 2013?

42

ADAM ROSENDORFF: I BELIEVE SO. I DON'T KNOW FOR SURE. AT THE END OF 2013.

43

MR. WADE: AND WE'LL GO THROUGH SOME DOCUMENTS ON THAT AND THAT MIGHT HELP REFRESH YOUR RECOLLECTION AS TO THE TIME. BUT YOU RECALL GENERALLY IN THAT TIME PERIOD THERE WAS AN AUDIT BY CDPH?

44

ADAM ROSENDORFF: MORE ACCURATELY, IT'S LABORATORY FIELD SERVICES, WHICH IS A DIVISION OF CDPH.

46

ADAM ROSENDORFF: THEY'RE NOT CALLED AUDITS, THEY'RE CALLED INSPECTIONS. AND LABORATORY FIELD SERVICES SUBMITS THE RESULTS OF THOSE INSPECTIONS TO THE CENTERS FOR MEDICARE AND MEDICARE SERVICES.

47

MR. WADE: OKAY. THANK YOU FOR THE CLARIFICATION, DOCTOR. SO THE STATE REGULATOR IN CALIFORNIA WORKS IN CONJUNCTION WITH THE FEDERAL REGULATOR; CORRECT?

49

MR. WADE: BUT THE STATE REGULATOR IS LOOKING AT YOUR COMPLIANCE WITH THOSE FEDERAL CLIA REGULATIONS WE TALKED ABOUT YESTERDAY; RIGHT?

51

MR. WADE: OKAY. AND YOU RECALL IN YOUR TESTIMONY YESTERDAY THE GOVERNMENT ASKED YOU QUESTIONS IN PARTICULAR ABOUT A COUPLE OF EMAILS THAT RELATED TO COMMUNICATIONS WITHIN THE COMPANY IN ADVANCE OF THOSE AUDITS. DO YOU RECALL THAT?

53

MR. WADE: OKAY. AND ONE EMAIL THAT YOU SENT WAS ABOUT THE PREPARATIONS FOR THE AUDIT. DO YOU RECALL THAT?

55

MR. WADE: AND YOU WERE TAKING A LEAD ORGANIZING ROLE IN THAT; IS THAT RIGHT?

57

MR. WADE: AND THERE WAS ANOTHER ONE ABOUT THE PATH THAT AUDITORS WERE GOING TO WALK, THEY WERE GOING TO TAKE WALKING THROUGH THE BUILDING; RIGHT?

58

ADAM ROSENDORFF: THAT EMAIL WAS FROM ELIZABETH.

59

MR. WADE: RIGHT. YOU RECALL THAT?

61

MR. WADE: BUT I BELIEVE YOU WERE ON THE EMAIL; RIGHT?

63

MR. WADE: AND IT WAS FROM MS. HOLMES?

65

MR. WADE: OKAY. AND DO YOU RECALL BEING ASKED QUESTIONS ABOUT THAT?

66

ADAM ROSENDORFF: DURING MY PRIOR TESTIMONY?

69

MR. WADE: OKAY. AND I'D LIKE TO JUST BACK UP AND ASK SOME BROADER QUESTIONS TO SET THE FRAME OF THIS AUDIT IN TOTAL, AND THEN WALK THROUGH SOME OF -- SOME MORE FACTS RELATING TO THAT AUDIT. OKAY?

71

MR. WADE: OKAY. WE DISCUSSED YESTERDAY HOW WHEN A LAB APPLIES FOR A CLIA LICENSE THEY HAVE AN INITIAL INSPECTION. DO YOU RECALL THAT?

73

MR. WADE: AND THAT HAD ALREADY BEEN DONE PRIOR TO THIS 2013 INSPECTION; RIGHT?

74

ADAM ROSENDORFF: IT WOULD HAVE HAD TO HAVE BEEN DONE, OTHERWISE THE LAB WOULD NOT BE PERMITTED TO REPORT RESULTS.

75

MR. WADE: RIGHT.

76

ADAM ROSENDORFF: IT WAS PRIOR TO WHEN I JOINED THE COMPANY.

77

MR. WADE: YOU WOULDN'T BE ABLE TO HAVE A JOB WHERE YOU'RE ON A CLIA CERTIFICATE IF THERE HADN'T BEEN THAT INSPECTION; RIGHT?

79

MR. WADE: OKAY. AND AFTER THAT YOU SAID THEY'RE ALLOWED TO START PROCESSING SAMPLES, BUT THERE ARE ALSO ONGOING INSPECTION REQUIREMENTS FROM THE REGULATORS?

81

MR. WADE: OKAY. AND SHORTLY AFTER THAT, THEY CAME IN TO CONDUCT THIS 2013 INSPECTION WHICH WAS A ROUTINE INSPECTION THAT IS DONE EVERY TWO YEARS; RIGHT?

83

MR. WADE: AND SO DO YOU RECALL THAT THE INITIAL CERTIFICATION OF THE THERANOS LAB WAS IN ABOUT SOMETIME IN 2011?

84

ADAM ROSENDORFF: I HAVE NO IDEA WHEN THE INITIAL CERTIFICATION WAS.

85

MR. WADE: BUT YOU DO KNOW THAT THESE INSPECTIONS TAKE PLACE EVERY TWO YEARS; RIGHT?

87

MR. WADE: SO IS IT REASONABLE TO ASSUME THAT THE LAST INSPECTION PROBABLE WOULD HAVE BEEN ABOUT TWO YEARS BEFORE THE ONE YOU DEALT WITH IN LATE 2013?

88

ADAM ROSENDORFF: THAT'S AN EXTRAPOLATION. THAT'S A CONCLUSION THAT YOU MIGHT WANT TO DRAW. I DON'T KNOW HOW MUCH TIME NEEDS TO ELAPSE BETWEEN THE INITIAL INSPECTION AND THE FOLLOW-UP INSPECTION. I KNOW THAT THE ROUTINE INSPECTIONS ARE EVERY TWO YEARS.

89

MR. WADE: OKAY. AND YOU KNOW THAT ONE OF THOSE INSPECTIONS OCCURRED IN LATE 2013?

91

MR. WADE: THAT WAS A ROUTINE SURVEY?

93

MR. WADE: OKAY. AND THIS WAS -- JUST TO REMIND US OF THE TIMELINE, THIS WAS SHORTLY AFTER THE COMMERCIAL LAUNCH IN NOVEMBER OF 2013 THAT WE DISCUSSED YESTERDAY; RIGHT?

94

ADAM ROSENDORFF: CAN YOU CLARIFY WHAT YOU MEAN BY "COMMERCIAL"?

95

MR. WADE: SURE. YOU RECALL THE COMMUNICATION THAT I SHOWED YOU WITH MR. BALWANI IN EARLY NOVEMBER OF 2013 WHERE HE SAID YOU WERE READY TO OPEN TO THE PUBLIC. DO YOU RECALL THAT EMAIL YESTERDAY?

97

MR. WADE: OKAY. THAT'S WHAT I'M TALKING ABOUT WHEN I SAY -- WHY DON'T WE DESCRIBE IT AS THE PUBLIC LAUNCH, OKAY? WOULD THAT BE HELPFUL?

99

MR. WADE: SO THE PUBLIC LAUNCH, YOU RECALL THAT HAPPENING IN EARLY NOVEMBER OF 2013; RIGHT?

101

MR. WADE: AND THIS INSPECTION HAPPENED A SHORT TIME AFTER THAT LAUNCH; RIGHT?

103

MR. WADE: OKAY. AND IT HAPPENED A COUPLE OF MONTHS AFTER THAT SOFT LAUNCH FOR FRIENDS AND FAMILY THAT WE TALKED ABOUT YESTERDAY; RIGHT?

105

MR. WADE: OKAY. AND THESE ARE REGULARLY SCHEDULED EVENTS; RIGHT?

107

MR. WADE: AND THERANOS KNEW IN ADVANCE THAT THE INSPECTOR WAS GOING TO ARRIVE?

109

MR. WADE: AND IT'S PRETTY ROUTINE IN ADVANCE OF SUCH A SURVEY FOR A LAB TO PREPARE AND MAKE SURE IT'S READY FOR THE SURVEY; RIGHT?

111

MR. WADE: AND THAT HAPPENS ON THE ROUTINE BASIS FOR THESE SURVEYS AS PART OF STANDARD PRACTICE?

113

MR. WADE: OKAY. AND THERANOS DID PREPARE?

114

ADAM ROSENDORFF: WE DID. WE DID. WE ALSO HAD A CONSULTANT. HIS NAME WAS JERRY HURST. WE WANTED HIM TO COME IN TO DO A PREINSPECTION TO ASSESS OUR READINESS. HE WASN'T AVAILABLE.

115

MR. WADE: BUT YOU HAD HIM AS A RESOURCE --

117

MR. WADE: -- IN THAT TIME PERIOD; CORRECT?

119

MR. WADE: AND THAT WAS MR. JERRY HURST OR DR. JERRY HURST?

120

ADAM ROSENDORFF: I DO NOT KNOW HIS EDUCATION.

121

MR. WADE: OKAY. BUT YOU UNDERSTOOD AT THE TIME THAT HE WAS A VERY EXPERIENCED LAB PERSON; RIGHT?

123

MR. WADE: AND HE WAS, HE WAS ON A RETAINER OR SOME SORT OF AN AGREEMENT --

125

MR. WADE: -- THAT AGREEMENT WAS WITH THE COMPANY FOR HIM TO PROVIDE ADVISORY SERVICES TO THE COMPANY ON AN AS-NEEDED BASIS; RIGHT?

126

ADAM ROSENDORFF: YES. HE HAD BEEN AN INSPECTOR BEFORE.

127

MR. WADE: HE HAD ACTUALLY BEEN, I BELIEVE, A CDPH INSPECTOR; RIGHT?

129

MR. WADE: AND SO HE WAS VERY FAMILIAR WITH THE TYPES OF ISSUES THAT CDPH WOULD LOOK AT; RIGHT?

131

MR. WADE: AND HE KNEW THE PROCEDURES AND POLICIES THAT WOULD NEED TO BE IN PLACE IN ORDER TO SATISFY THE REGULATORS; RIGHT?

133

MR. WADE: AND HE WAS SOMEWHAT OF AN EXPERT ON THOSE ISSUES, WAS HE NOT?

134

ADAM ROSENDORFF: THAT'S A VERY SUBJECTIVE ASSESSMENT. ARE YOU ASKING FOR MY OPINION OR --

135

MR. WADE: WELL, LET ME ASK YOU THIS: HE WAS EXPERIENCED ON THOSE MATTERS; RIGHT?

137

MR. WADE: AND HE WAS EXPERIENCED AS A CDPH INSPECTOR?

139

MR. WADE: AND HE WAS KNOWLEDGEABLE ABOUT THOSE PRACTICES AND PROCEDURES THAT WOULD BE CONSIDERED IN THOSE INSPECTIONS. RIGHT?

140

ADAM ROSENDORFF: YES, HE WAS FAMILIAR WITH THEM.

141

MR. WADE: OKAY. AND I BELIEVE YOU TESTIFIED A MINUTE AGO THAT IN CONNECTION WITH THAT INSPECTION YOU QUARTERBACKED, IF YOU WILL, THE PREPARATION WORK?

142

ADAM ROSENDORFF: I OUTLINED IN AN EMAIL MY EXPECTATIONS FOR WHAT NEEDED TO HAPPEN IN TERMS OF TRAINING AND DOCUMENTATION IN ADVANCE OF THE INSPECTION.

143

MR. WADE: OKAY. AND LET'S LOOK AT, LET'S LOOK AT THAT EMAIL THAT I THINK YOU'RE REFERRING TO, WHICH IS IN EVIDENCE. WE CAN PUT IT UP ON THE SCREEN. IT'S EXHIBIT 4044.

144

ADAM ROSENDORFF: I'M JUST -- IS IT OKAY IF I JUST LOOK AT IT ON THE SCREEN, OR DO YOU WANT ME TO TURN TO IT IN MY BINDER?

145

MR. WADE: THAT'S FINE. I JUST WANT YOU TO KNOW IF YOU EVER HAVE ANY QUESTION AND WANT TO LOOK AT THE ENTIRE DOCUMENT, WE HAVE THEM UP THERE AND WE'LL BE PREPARED TO GIVE YOU THAT OPPORTUNITY. OKAY?

147

MR. WADE: SO WE'LL PUT UP EXHIBIT 4044. I THINK YOU -- IT'S ON YOUR SCREEN. DO YOU SEE IT?

149

MR. WADE: AND I BELIEVE YOU TESTIFIED A LITTLE BIT ABOUT THIS YESTERDAY; IS THAT RIGHT?

151

MR. WADE: OKAY. AND I WANT TO JUST WALK THROUGH IT IN SLIGHTLY MORE DETAIL. YOU TALKED ABOUT ALL OF THE MATERIALS THAT NEED TO BE ORGANIZED AND PROVIDED IN ORDER TO BE READY FOR THAT INSPECTION AND TO BE COMPLIANT UNDER CLIA; RIGHT?

153

MR. WADE: AND YOU TALKED ABOUT TRAINING DOCUMENTS; RIGHT?

155

MR. WADE: AND YOU TALKED ABOUT DIPLOMAS AND EDUCATIONAL QUALIFICATION DOCUMENTS FOR THE STAFF?

157

MR. WADE: AND THAT WAS BECAUSE, I THINK WE TALKED ABOUT YESTERDAY, IT'S YOUR RESPONSIBILITY TO CERTIFY THAT PEOPLE ARE QUALIFIED TO PERFORM CERTAIN FUNCTIONS WITHIN THE LAB; RIGHT?

159

MR. WADE: AND ONE OF THE WAYS YOU DO THAT IS SOMETIMES YOU GET THE RESUMES AND THINGS AND YOU ACTUALLY DOCUMENT THEIR QUALIFICATIONS; RIGHT?

160

ADAM ROSENDORFF: CORRECT. YOU HAVE TO MAKE SURE THAT THEIR EDUCATION AND TRAINING MEETS THE CLIA REQUIREMENTS FOR EACH POSITION.

161

MR. WADE: AND YOU DID THAT; RIGHT?

163

MR. WADE: AND YOU WANTED THAT ORGANIZED SO IT COULD BE REVIEWED BY THE INSPECTOR; CORRECT?

165

MR. WADE: AND YOU ALSO WANTED THAT ORG CHART; RIGHT?

167

MR. WADE: AND THERE WERE ALSO SOME SOP'S THAT YOU WANTED THE COMPANY TO PREPARE; RIGHT?

169

MR. WADE: OKAY. DO YOU SEE THAT YOU WANTED THE SOP FOR INTERNAL PROFICIENCY TESTING OF LDT'S TO BE READY FOR THAT INSPECTION; RIGHT?

171

MR. WADE: AND YOU WANTED -- IF WE GO TO THE NEXT SET OF MATERIALS, YOU WANTED THE ONGOING QC ANALYSIS IN THE LEVEY-JENNINGS CHART FOR LDT'S AVAILABLE; RIGHT?

173

MR. WADE: AND THAT'S THIS DAILY QC PROCEDURE THAT WE'VE TALKED ABOUT A BIT; RIGHT?

174

ADAM ROSENDORFF: JUST TO EXPLAIN TO THE JURY, LEVEY-JENNINGS IS A WAY OF LOOKING AT HOW QC PERFORMANCE OVER A MONTH OR AN EXTENDED PERIOD OF TIME.

175

MR. WADE: AND I DON'T KNOW THAT WE HAVE SEEN LEVEY-JENNINGS CHARTS IN ANY OF THE CHARTS THAT HAVE BEEN SHOWN, BUT IN ANY MATTER, THAT PULLS DATA FROM A PRETTY LENGTHY PERIOD OF TIME RELATED TO QC; RIGHT?

177

MR. WADE: AND AS PART OF THE REVIEW OF THE QC, YOU LOOK AT TRENDS OVER A LONG PERIOD OF TIME AND HOW THE QC PERFORMED; IS THAT RIGHT?

179

MR. WADE: AND THOSE LEVEY-JENNINGS CHARTS ARE THE COMPILATION OF THAT QUALITY CONTROL DATA?

181

MR. WADE: AND THERE'S BEEN SOME DISCUSSION WITHIN THIS CASE ABOUT WESTGARD RULES.

182

ADAM ROSENDORFF: CORRECT, CORRECT.

183

MR. WADE: YOU'RE FAMILIAR WITH THOSE?

185

MR. WADE: AND WE'LL TALK ABOUT IT MORE IN A BIT. BUT AS A GENERAL MATTER, THOSE ARE RULES THAT YOU KIND OF APPLIED TO THOSE LEVEY-JENNINGS CHARTS; RIGHT?

187

MR. WADE: AND THAT'S TO MAKE SURE THAT THE PERFORMANCE OVER THE LONG TERM OF QUALITY CONTROL, IT MEETS CLIA STANDARDS; RIGHT?

188

ADAM ROSENDORFF: CLIA DOES NOT OUTLINE OR PRESCRIBE HOW ONE SHOULD LOOK AT LEVEY-JENNINGS PLOTS, INTERPRET THEM, OR IMPLEMENT RULES. THEY SAY THAT CALIBRATION AND CONTROL PROCEDURES NEED TO BE IN PLACE.

189

MR. WADE: RIGHT. THEY DON'T PROVIDE THE SPECIFICITY?

190

ADAM ROSENDORFF: THEY DON'T TELL YOU HOW TO DO IT.

191

MR. WADE: IT'S UP TO THE LAB DIRECTOR TO FIGURE OUT THE BEST WAY TO IMPLEMENT THAT; RIGHT?

193

MR. WADE: AND WORKING WITH THE QUALITY MANAGER?

195

MR. WADE: OKAY. AND A COMMON WAY THAT THAT'S DONE WITHIN THE INDUSTRY IS TO APPLY WESTGARD RULES TO LEVEY-JENNINGS CHARTS; CORRECT?

197

MR. WADE: AND YOU DID THAT AT THERANOS?

199

MR. WADE: AND SPECIFICALLY, YOU WANTED THEM TO GATHER THE LEVEY-JENNINGS CHARTS FOR THE LDT'S?

200

ADAM ROSENDORFF: WELL, I JUST WANT TO CLARIFY. SO I CALLED THE MEETING WITH ELIZABETH AND OTHER TO DISCUSS HOW WE WOULD ASSESS QC PERFORMANCE OVER TIME. WE DID NOT HAVE AN SOP REGARDING WHAT QC TO DISQUALIFY ON THE BASIS OF VIOLATION OF A WESTGARD RULE. IF THAT ANSWERS YOUR QUESTION. YOU SAID, YOU DID THAT, YOU LOOKED AT WESTGARD. BUT JUST TO BE CLEAR, WE DID NOT HAVE A PROCEDURE IN PLACE WHERE WE WOULD DISQUALIFY A QC DATA POINT ON THE WESTGARD RULES.

201

MR. WADE: AND WE'LL TALK ABOUT THE QC POLICIES IN MORE DETAIL IN A BIT, BUT JUST SO WE'RE CLEAR ON THIS POINT, THE ADAPTION AND IMPLEMENTATION OF THE QC POLICY WAS YOUR JOB; RIGHT, SIR?

203

MR. WADE: OKAY. LET'S KEEP GOING DOWN THIS LIST.

204

ADAM ROSENDORFF: I MEAN, YOU KEEP SAYING IT'S MY JOB, IT'S MY JOB. BUT I WAS PART OF A LARGE COMPANY WITH DELEGATED ROLES AND COMPLICATED OPERATIONS AND A LOT OF TRUST I PUT INTO OTHER INDIVIDUALS TO EXECUTE ON THESE. SO I'M NOT SURE, YOU KNOW, WHEN YOU SAY IT WAS YOUR JOB, IT WAS YOUR JOB. YES, I DID MY JOB, RIGHT, BUT I ALSO DEPENDED ON A LOT OF PEOPLE AROUND ME.

205

MR. WADE: YOU DID DEPEND ON A LOT OF QUALIFIED PEOPLE AROUND YOU; RIGHT?

207

MR. WADE: AND UNDER THE CLIA REGULATIONS, YOU'RE ACTUALLY PERMITTED TO RELY ON THOSE QUALIFIED PEOPLE, AREN'T YOU?

209

MR. WADE: IF THEY MEET THE REQUIREMENTS SET FORTH IN THE REGULATIONS FOR THEIR POSITIONS; RIGHT?

210

ADAM ROSENDORFF: BUT IT'S NOT JUST THEM. ON AN OPERATIONAL LEVEL YOU HAVE PROJECT MANAGERS, CUSTOMER SERVICE REPS, SOFTWARE PEOPLE, UPPER MANAGEMENT, ALL CONTRIBUTING TO THE QUALITY OF THE SERVICES PROVIDED BY THE LABORATORY. I ALONE FULFILLED MY DUTIES AS LAB DIRECTOR, BUT IT'S JUST NOT REASONABLE TO EXPECT THAT I COULD HAVE GUARANTEED THE QUALITY OF SERVICES COMING OUT OF THE LAB.

211

MR. WADE: WELL, SIR, I THINK YESTERDAY WE WENT THROUGH THE REGULATIONS; RIGHT? DO YOU RECALL THAT, 7603?

213

MR. WADE: OKAY. AND UNDER THOSE REGULATIONS, YOU'RE PERMITTED TO DELEGATE CERTAIN RESPONSIBILITIES WITHIN THE ORGANIZATION; RIGHT?

215

MR. WADE: OKAY. BUT UNDER THOSE REGULATIONS, ULTIMATELY YOU'RE RESPONSIBLE IF THOSE JOBS ARE NOT DONE PROPERLY; CORRECT?

216

ADAM ROSENDORFF: YES. BUT THERE ARE A NUMBER OF OTHER INDIVIDUALS --

217

MR. WADE: I DON'T HAVE A QUESTION PENDING, YOUR HONOR.

218

JUDGE DAVILA: YOU CAN ASK ONE.

219

MR. WADE: OKAY. GOOD.

220

MR. WADE: I'D LIKE TO CONTINUE DOWN THIS CHART. THE QUESTION THAT I WAS ASKING WAS, ON NOVEMBER 26TH OF 2013, YOU SPECIFICALLY ASKED THAT THE ONGOING QC ANALYSIS IN THE LEVEY-JENNINGS CHARTS FOR LDT'S, WHICH IS THE DAILY QC PROCEDURE, BE COMPILED AND READY FOR THE INSPECTORS; RIGHT?

222

MR. WADE: OKAY. AND YOU SPECIFICALLY ASKED THAT THE CALIBRATION VERIFICATION PLAN FOR THE LDT'S BE PREPARED AND QUALIFIED AND READY FOR THE INSPECTORS; RIGHT?

224

MR. WADE: OKAY. AND YOU SPECIFICALLY ASKED THAT THE PROCEDURE FOR RETESTING OF CRITICAL VALUES BE THERE. DO YOU SEE THAT?

226

MR. WADE: AND THEN IF WE GO DOWN TO WEDNESDAY --

227

ADAM ROSENDORFF: I JUST WANT TO --

228

MR. WADE: THERE'S NO QUESTION PENDING, SIR. IF WE GO DOWN TO WEDNESDAY, THE SOP FOR THERANOS LIS -- DO YOU SEE THAT THERE?

230

MR. WADE: OKAY. AND THESE DOCUMENTS ARE -- THIS DOCUMENT HERE, YOU HAVE DIFFERENT DATES ON THIS BECAUSE YOU'RE KIND OF MAPPING OUT DUE DATES SO PEOPLE CAN GET THIS DONE AND READY AND YOU CAN HAVE IT REVIEWED AND READY FOR THE INSPECTORS; RIGHT?

232

MR. WADE: OKAY. THE SOP FOR THERANOS LIS, THAT WAS THE LIS THAT WE TALKED ABOUT YESTERDAY; CORRECT?

234

MR. WADE: AND YOU SEE THERE'S AN SOP FOR SUPER MARIO. DO YOU SEE THAT REFERENCE?

236

MR. WADE: AND WE TALKED A LITTLE BIT ABOUT SUPER MARIO YESTERDAY. DO YOU RECALL?

238

MR. WADE: AND IT'S A GREAT NAME, ISN'T IT?

239

ADAM ROSENDORFF: NO COMMENT.

240

MR. WADE: OKAY. DO YOU SEE THERE'S A SEPARATION BETWEEN THE LIS AND SUPER MARIO. DO YOU SEE THEY'RE IDENTIFIED AS TWO SEPARATE THINGS? DO YOU SEE THAT?

241

ADAM ROSENDORFF: YES. SO THERE'S AMBIGUITY HERE BECAUSE THERE WAS AN LIS FOR THE FDA APPROVED COMMERCIAL INSTRUMENTS CALLED LAB DAQ, AND THERE WAS AN LIS FOR THE THERANOS METHODS CALLED SUPER MARIO.

242

MR. WADE: ACTUALLY, DOES THIS REFRESH YOUR RECOLLECTION IN ANY WAY, SIR, THAT -- ACTUALLY, LET ME STRIKE THAT. DO YOU SEE THE NAME ANAM NEXT TO THAT?

244

MR. WADE: AND DOWN WHO ANAM WAS?

245

ADAM ROSENDORFF: ANAM KHAN, A CUSTOMER SERVICE REPRESENTATIVE.

246

MR. WADE: RIGHT. SHE DEALT WITH CUSTOMER SERVICE ISSUES THAT CAME UP FROM MEDICAL PRACTICES; RIGHT?

248

MR. WADE: AND DOES LOOKING AT THIS REFRESH YOUR RECOLLECTION THAT SUPER MARIO WAS ACTUALLY THE CUSTOMER SERVICE DATABASE SYSTEM THAT DOCUMENTED CUSTOMER SERVICE CALLS WITHIN THE COMPANY?

249

ADAM ROSENDORFF: NO. I BELIEVE WE USED SALES FORCE FOR THAT FOR CUSTOMER SERVICE RELATIONS. THERE WAS, THERE WAS AN INTERFACE AVAILABLE TO THE COLLECTION SITES THAT WOULD TELL THEM WHAT KINDS OF TUBES TO PULL GIVEN THE ORDERS THAT WERE COMING IN. IN OTHER WORDS, IF YOU NEEDED A COMPLETE METABOLIC PANEL, IT WOULD BE A RED TOP; IF YOU NEEDED A CBC, IT WOULD BE A LITHIUM HEPARIN TUBE.

250

MR. WADE: OKAY. LET ME ASK THIS, AND MAYBE IT WAS SALES FORCE, BUT DO YOU RECALL THAT THERE WAS A COMPUTER SYSTEM THAT DOCUMENTED THOSE INCOMING INQUIRIES; RIGHT?

252

MR. WADE: AND ANAM WAS THE PERSON RESPONSIBLE FOR THAT?

254

MR. WADE: AND THERE WAS ACTUALLY AN SOP SET WITHIN THE CLIA LAB THAT RELATED TO THAT; RIGHT?

255

ADAM ROSENDORFF: I DO NOT RECALL.

256

MR. WADE: OKAY. DO YOU RECALL WHAT SOP YOU WERE ASKING OR WHAT PROCEDURE -- YEAH, I'M SORRY, WHAT SOP YOU WERE ASKING ANAM TO PREPARE IN ADVANCE OF THIS NOVEMBER 2013 AUDIT? DO YOU RECALL?

257

ADAM ROSENDORFF: THE INTENT WAS FOR AN SOP FOR HOW ONE ENTERS DATA INTO THE THERANOS LIS AND HOW THAT -- ESSENTIALLY MANUAL FOR HOW THAT SOFTWARE WORKS. I -- READING THE EMAIL NOW, I DO NOT BELIEVE THAT IT'S EXPLICIT OR DETAILED ENOUGH TO HAVE GIVEN, YOU KNOW, CLEAR INSTRUCTIONS TO HER.

258

MR. WADE: DO YOU REGRET THAT, SIR?

259

ADAM ROSENDORFF: NO. I, YOU KNOW, I PUT TOGETHER A LIST AS BEST AS I COULD WITHIN THE TIME CONSTRAINTS AT THE TIME.

260

MR. WADE: AND YOU WERE GOING TO REVIEW WHATEVER THEY PREPARED ANYWAY; RIGHT?

262

MR. WADE: OKAY. AND DO YOU SEE THERE'S AN SOP WITH RESPECT TO REDRAWS THERE. DO YOU SEE THAT?

264

MR. WADE: OKAY. AND FINALLY, ON THIS PAGE DO YOU SEE THERE'S A REFERENCE TO A MOCK AUDIT BY JERRY HURST?

266

MR. WADE: AND DO YOU RECALL WHETHER OR NOT THAT HAD OCCURRED?

267

ADAM ROSENDORFF: IT DID NOT.

268

MR. WADE: OKAY. AND THAT WAS DUE TO A SCHEDULING ISSUE?

269

ADAM ROSENDORFF: HE WAS UNAVAILABLE.

272

MR. WADE: AND IF WE GO TO THE NEXT PAGE, YOU SEE THERE AT THE BOTTOM IT SAYS, "MYSELF AND SUPERVISORS MINIMALLY PRESENT TO HANDLE INSPECTION STARTING AT 10:30."

274

MR. WADE: AND JUST MINIMAL PRESENCE IS WHAT YOU THOUGHT WAS MOST PERTINENT FOR THE INSPECTION?

275

ADAM ROSENDORFF: NO. I WAS DESCRIBING THE MINIMUM NUMBER OF PEOPLE THAT I WOULD EXPECT TO ATTEND THE INSPECTION. I WAS NOT SAYING THE NUMBERS OF PEOPLE SHOULD BE KEPT TO A MINIMUM.

276

MR. WADE: OH, OKAY. WELL, THANK YOU FOR YOUR CLARIFICATION ON THAT, DOCTOR. AND ONE OF THE REASONS THAT -- LET ME JUST MAKE SURE I WAS CLEAR. THE LDT'S THAT ARE REFERENCED WITHIN THAT, DO YOU SEE THAT DOCUMENT? IF WE CAN GO UP TO THE FIRST PAGE AND CAPTURE THE MIDDLE OF THE DOCUMENT. WHERE LDT'S ARE REFERENCED, THOSE ARE THE THERANOS SMALL SAMPLE ASSAYS; CORRECT?

278

MR. WADE: AND INCLUDING THE EDISON DEVICES; RIGHT?

280

MR. WADE: AND YOU WANTED TO MAKE SURE THAT EVERYTHING WAS APPROPRIATELY PREPARED FOR THE INSPECTION ON THOSE ITEMS; RIGHT?

282

MR. WADE: OKAY. AND ONE OF THE REASONS THAT YOU NEEDED TO BE PREPARED WAS BECAUSE WHEN AN INSPECTOR COMES IN, THEY MAY ASK FOR THE DOCUMENTATION?

284

MR. WADE: THEY DON'T TELL YOU IN ADVANCE EXACTLY WHAT DOCUMENTS OR INFORMATION THAT THEY'RE GOING TO LOOK FOR?

285

ADAM ROSENDORFF: CPA DOES, BUT NOT CLIA.

286

MR. WADE: AND THIS WAS A CLIA AUDIT; CORRECT?

288

MR. WADE: AND SO THE AUDITORS THAT WERE COMING IN, IN THIS CASE FROM THE CALIFORNIA DEPARTMENT OF HEALTH, COULD ASK FOR ANYTHING?

289

ADAM ROSENDORFF: CORRECT. CORRECT.

290

MR. WADE: OKAY. AND YOU NEED TO BE READY IN CASE THE INSPECTORS ASK FOR THE INFORMATION; RIGHT?

292

MR. WADE: AND THEY GET TO, THEY GET TO PREPARE WHATEVER QUESTIONS AND THEY GET TO PREPARE A LIST OF QUESTIONS AND INFORMATION THAT THEY WANT FROM THE LAB; RIGHT?

293

ADAM ROSENDORFF: THEY'RE ENTITLED TO ASK WHATEVER QUESTIONS THEY SEE FIT AT THE TIME.

294

MR. WADE: AND YOU'RE OBLIGATED TO GIVE THEM WHATEVER THEY ASK FOR; RIGHT?

296

MR. WADE: AND DID YOU DO THAT?

298

MR. WADE: AND AS A GENERAL MATTER, THEY COME IN AND YOU FEEL LIKE YOU'RE READY AND THEN YOU WAIT UNTIL THEY ASK QUESTIONS AND THEN YOU GIVE THEM WHATEVER THEY ASK FOR; RIGHT?

299

ADAM ROSENDORFF: JUST ANSWER THE QUESTION.

300

MR. WADE: JUST ANSWER THE QUESTION; RIGHT?

302

MR. WADE: THAT'S THE STANDARD APPROACH. YOU WAIT FOR THEIR INQUIRY AND THEN YOU PROVIDE THE INFORMATION AND RESPONSE?

304

MR. WADE: AND YOU DON'T GIVE THEM A GUIDED TOUR OF THE WHOLE FACILITY; RIGHT?

306

MR. WADE: AND YOU DON'T BRING THEM INTO THE R&D DEPARTMENT?

307

ADAM ROSENDORFF: WELL, IN OTHER LABORATORIES WE HAVE HAD CAP INSPECTION WHERE WE HAVE SHOWN CAP THE FACILITY.

308

MR. WADE: AND I'M JUST TALKING ABOUT HERE. YOU'VE TALKED ABOUT YOUR GENERAL PROCEDURE, WHICH IS THEY ASK A QUESTION, YOU WAIT, AND YOU GIVE THEM A RESPONSE?

310

MR. WADE: AND YOU DID THAT, SIR?

312

MR. WADE: AND YOU DIDN'T HIDE ANY INFORMATION FROM THESE INSPECTORS IN 2013 AT THERANOS, DID YOU?

314

MR. WADE: AND THAT WOULD BE A BIG PROBLEM IF YOU DID THAT; RIGHT?

316

MR. WADE: AND YOU NEVER WOULD DO THAT; RIGHT?

317

ADAM ROSENDORFF: I WOULD NEVER DO THAT, YES.

318

MR. WADE: I BELIEVE YOU TESTIFIED YESTERDAY THAT THE INSPECTOR WHO CAME IN ASKED TO SEE CERTAIN DOCUMENTS RELATING TO THERANOS'S LDT'S; RIGHT?

320

MR. WADE: THOSE ARE THE EDISON TESTS OR THE SMALL SAMPLE ASSAY TESTS; RIGHT?

321

ADAM ROSENDORFF: WHAT DO YOU MEAN BY "SMALL SAMPLE ASSAY TESTS"?

322

MR. WADE: WELL, LET ME -- LET ME STRIKE THAT. THESE ARE THE TESTS THAT THERANOS DEVELOPED THAT WERE RUNNING IN THE LAB; RIGHT?

324

MR. WADE: AND THEY WERE NOT -- THEY WERE RUN ON A SMALLER SAMPLE AS A GENERAL MATTER; RIGHT?

326

MR. WADE: AND SOME OF THEM WERE RUN ON A MODIFIED COMMERCIAL DEVICES THAT APPLIED SOME THERANOS MODIFICATIONS AND TECHNOLOGY; RIGHT?

328

MR. WADE: AND SOME OF THEM WERE RUN ON THE EDISON?

330

MR. WADE: RIGHT. AND THOSE ARE THE LDT'S?

331

ADAM ROSENDORFF: NONE OF THEM WERE RUN ON THE INSTRUMENTS THAT -- WELL, WITH THE EXCEPTION OF EDISON, THE REST WERE NOT RUN ON THERANOS DEVELOPED INSTRUMENTS.

332

MR. WADE: UNDERSTOOD. THERE WERE SOME ASSAYS THAT WERE RUNNING ON THERANOS DEVELOPED EDISONS; RIGHT?

334

MR. WADE: AND THEN THERE WERE SOME ASSAYS THAT WERE RUNNING ON COMMERCIAL DEVICES WHERE THERANOS HAD MODIFIED SOME OF THE SOFTWARE AND HARDWARE TECHNOLOGY TO RUN ITS ASSAYS; RIGHT?

336

MR. WADE: AND WHEN -- AND THOSE WERE RUN ON SMALL SAMPLES; RIGHT?

338

MR. WADE: AND SO WHEN WE'RE TALKING ABOUT LDT'S GENERALLY, IT'S ONE OF THOSE TWO CATEGORIES; RIGHT?

339

ADAM ROSENDORFF: CORRECT. THERE'S ALSO THE COMPLETE BLOOD COUNT WHERE THEY USED FLOW CYTOMETRY FOR SOME BIZARRE REASON TO DO COMPLETE BLOOD COUNTS. AND THEN THERE WAS A PT INR METHOD THAT WAS IN DEVELOPMENT THAT WAS ALSO LDT.

340

MR. WADE: AND SO THERE WERE TWO LDT'S IN ADDITION --

341

ADAM ROSENDORFF: THAT I CAN RECALL, YEAH.

342

MR. WADE: OKAY. AND WHEN YOU TESTIFIED YESTERDAY THAT THE INSPECTOR ASKED TO SEE CERTAIN DOCUMENTS RELATING TO THE THERANOS LDT'S, IT WAS ONE OF THOSE LDT'S?

343

ADAM ROSENDORFF: YES. I BELIEVE WE SHOWED THE INSPECTOR THE VALIDATION REPORTS FOR THE SMALL SAMPLES AS YOU CALL THEM THAT WERE RUN ON THE ADVIA'S AND THE EDISON LDT'S.

344

MR. WADE: ON BOTH?

346

MR. WADE: YOU SHOWED THEM BOTH VALIDATION REPORTS; RIGHT?

348

MR. WADE: ONE FOR EDISONS?

350

MR. WADE: AND ONE FOR THE MODIFIED LDT'S; RIGHT?

352

MR. WADE: AND SO THEY WERE AWARE THAT YOU WERE USING THAT HARDWARE WITHIN THE LAB; RIGHT?

354

MR. WADE: AND DO YOU HAPPEN TO RECALL WHICH PARTICULAR VALIDATION REPORTS YOU SHOWED THEM?

355

ADAM ROSENDORFF: I DO NOT RECALL WHICH ANALYTES WE SHOWED THEM.

356

MR. WADE: OKAY. BUT ONE OF EACH?

358

MR. WADE: AND SO YOU TESTIFIED YESTERDAY THAT THERE WERE SOME COMMUNICATIONS WITHIN THE COMPANY AROUND ACCESS TO THE NORMANDY LAB. DO YOU RECALL THAT?

360

MR. WADE: OKAY. AND THE PORTION OF THE -- THAT'S THE PORTION OF THE CLIA LAB THAT WAS DOWNSTAIRS?

362

MR. WADE: OKAY. AND THE QUESTION IS RELATED TO WHETHER YOU WOULD AFFIRMATIVELY LEAVE THE INSPECTORS DOWNSTAIRS THERE; RIGHT?

363

ADAM ROSENDORFF: NO. THERE WAS AN EMAIL FROM ELIZABETH SAYING HAS THE PATH BEEN CEMENTED? AND SHE REFERENCED THE NEW YORK STATE INSPECTION. AND THERE WAS VERBAL INSTRUCTION FROM SUNNY BALWANI THAT NOBODY WAS TO ENTER OR LEAVE THE NORMANDY LAB DURING THE PERIOD OF THE INSPECTION.

364

MR. WADE: AND NO ONE ENTERING AND LEAVING AND GOING IN AND OUT OF THE NORMANDY LAB RELATED TO STAFF, NOT THE INSPECTOR; CORRECT? BECAUSE IF THEY ASKED TO SEE IT, YOU WOULD SHOW IT TO THEM; RIGHT?

365

ADAM ROSENDORFF: I WOULD BE OBLIGED AND WOULD BE REQUIRED TO SHOW IT TO THEM.

366

MR. WADE: AND THEY WERE JUST ASKING THAT OTHER EMPLOYEES NOT BE RUNNING IN AND OUT OF THERE DURING THE INSPECTION; RIGHT? IS THAT YOUR RECOLLECTION?

367

ADAM ROSENDORFF: CORRECT. CORRECT.

368

MR. WADE: OKAY. WELL, I'M GOING TO ASK SOME MORE SPECIFIC QUESTIONS OF THAT. WHY DON'T WE TAKE A LOOK AT 4047, WHICH IS IN EVIDENCE. WE'LL PUT IT UP ON THE SCREEN. THIS IS THE EMAIL THAT YOU WERE REFERRING TO FROM YESTERDAY?

370

MR. WADE: AND IT SAYS BELOW -- LET'S HIGHLIGHT THAT QUESTION FROM MS. HOLMES. DO YOU SEE THAT THERE? IT SAYS, "LET ME KNOW IF THE PATH FOR WALKING THE AUDITORS IN AND DOWNSTAIRS HAS BEEN CEMENTED SO WE CAN AVOID AREAS THAT CANNOT BE ACCESSED, AND WHAT THAT PATH IS." RIGHT?

372

MR. WADE: SHE'S NOT SAYING DON'T GO THERE; RIGHT?

373

ADAM ROSENDORFF: SHE IS ASKING TO KNOW WHAT AREAS ARE GOING TO BE SHOWN TO THE INSPECTORS.

374

MR. WADE: WELL, SHE'S, SHE'S ACTUALLY ASKING WHAT THE PATH IS FOR WALKING THE AUDITORS IN AND DOWNSTAIRS; RIGHT?

375

ADAM ROSENDORFF: I THINK YOU'RE SORT OF BEING SEMANTIC. YOU'RE SORT OF SPLITTING HAIRS RIGHT NOW. BUT THAT'S THE WAY THAT I READ THE EMAIL. SHE WANTED TO KNOW WHAT AREAS WOULD BE SHOWN TO INSPECTORS AND WHAT AREAS WOULD NOT BE.

376

MR. WADE: OKAY. WELL, LET'S --

377

ADAM ROSENDORFF: THAT'S HOW I READ THE EMAIL.

378

MR. WADE: I UNDERSTAND. I UNDERSTAND. I APPRECIATE THAT EMAIL. LET'S LOOK AT THE TOP. THERE'S ANOTHER EMAIL. DO YOU SEE THAT?

380

MR. WADE: IT SAYS, "(KERRY, PLEASE DELINEATE THIS BASED ON WHAT WE DID WITH THE NEW YORK INSPECTOR RECENTLY AND SEND THAT OUT)." DO YOU RECALL THAT?

382

MR. WADE: AND THE GOVERNMENT SHOWED YOU THIS EMAIL YESTERDAY; RIGHT?

383

ADAM ROSENDORFF: YES, THEY DID.

384

MR. WADE: AND DID THE GOVERNMENT SHOW YOU MS. JOHNSON'S RESPONSE YESTERDAY?

385

ADAM ROSENDORFF: NO, I DON'T BELIEVE I'VE SEEN A RESPONSE FROM MS. JOHNSON.

386

MR. WADE: LET'S TAKE A LOOK AT IT. IF YOU LOOK AT EXHIBIT 12749, WHICH SHOULD BE IN YOUR BINDER 2 UP THERE.

388

MR. WADE: 12749.

389

ADAM ROSENDORFF: I SEE AN EMAIL HERE FROM KERRY.

390

BY MR. WADE:

391

MR. WADE: OKAY. JUST TAKE A MINUTE AND FAMILIARIZE YOURSELF WITH THAT EMAIL. AND THIS IS AN EMAIL THAT YOU'RE ON?

393

MR. WADE: AND IT RELATES TO THESE ISSUES?

395

MR. WADE: I WOULD MOVE FOR THE ADMISSION OF EXHIBIT 12749.

396

MR. BOSTIC: I APOLOGIZE, YOUR HONOR. I'M STILL LOOKING FOR A COPY OF THAT EMAIL. I DON'T THINK I HAVE IT.

397

MR. WADE: WE'LL GIVE COUNSEL A MINUTE.

398

(PAUSE IN PROCEEDINGS.)

399

MR. WADE: IT MAY BE 12479. I'M LOOKING AT AN EMAIL --

400

MR. WADE: IS THE DATE OF YOUR EMAIL AT THE TOP 12-4-2013?

401

ADAM ROSENDORFF: NO, SIR. 11-27-2013.

402

MR. WADE: I MUST HAVE TRANSPOSED MY TYPING. CAN WE LOOK AT 12479?

403

ADAM ROSENDORFF: THAT'S WHAT I'M LOOKING AT.

404

MR. WADE: OH, YOU'RE LOOKING AT 12479. DOES COUNSEL HAVE THAT?

405

MR. BOSTIC: I DO NOW.

406

JUDGE DAVILA: 12479 IS ADMITTED, AND IT MAY BE PUBLISHED.

407

(DEFENDANT'S EXHIBIT 12479 WAS RECEIVED IN EVIDENCE.)

408

BY MR. WADE:

409

MR. WADE: OKAY. AND IF WE CAN GO DOWN TO THE BOTTOM ACTUALLY AND LOOK AT THOSE BOTTOM EMAILS. NOW, THIS IS A FAMILIAR EMAIL TO YOU; RIGHT? THIS IS THE ONE THAT THE GOVERNMENT SHOWED YOU YESTERDAY?

411

MR. WADE: AND THIS IS THE EMAIL WHERE MS. HOLMES SAYS "LET ME KNOW IF THE PATH FOR WALKING THE AUDITORS IN AND DOWNSTAIRS HAS BEEN CEMENTED SO WE CAN AVOID THE AREAS THAT CANNOT BE ACCESSED, AND WHAT THE PATH IS." DO YOU SEE THAT?

413

MR. WADE: AND THEN THE RESPONSE IS -- RELATES TO THE NEW YORK -- USING THE PATH OF THE NEW YORK INSPECTOR; RIGHT?

415

MR. WADE: OKAY. LET'S LOOK AT -- LET'S GO UP THE CHAIN. AND THIS IS MS. JOHNSON'S RESPONSE. DO YOU SEE THAT?

417

MR. WADE: AND LET'S LOOK AT IT. IT SAYS "NO PROBLEM. "THE PATH FOR THE NEW YORK INSPECTION WAS FROM THE CONFERENCE ROOM NEAR THE FRONT LOBBY DIRECTLY TO THE LAB GOING PAST HR. ALL OF THE BULLETIN BOARDS FROM THE LOBBY TO HR WERE COVERED WITH PAPER SO THE INSPECTORS COULD NOT VIEW ANY OF THE DRAWINGS OR ITEMS ON THE BOARD. DAVID DO ASSISTED WITH PLACING THE PAPER ON THE WHITE BOARDS." DO YOU SEE THAT?

419

MR. WADE: PUTTING THE PAPER ON THE WHITE BOARDS WAS TO COVER POTENTIAL TRADE SECRETS; RIGHT?

420

ADAM ROSENDORFF: NO. MY OPINION -- I DON'T KNOW.

421

MR. WADE: I'M ASKING FOR YOUR RECOLLECTION AS OPPOSED TO YOUR OPINION. DO YOU HAVE A RECOLLECTION?

422

ADAM ROSENDORFF: I DO NOT RECALL THAT THE ISSUE WAS TRADE SECRETS. WE WOULD NOT HAVE PINNED UP TRADE SECRETS ON A BULLETIN BOARD. I MEAN, WHO WOULD DO THAT?

423

MR. WADE: OKAY. BUT -- I UNDERSTAND YOU'RE OFFERED YOUR OPINION ON THAT. DO YOU RECALL THE BULLETIN BOARDS IN THIS -- ON THIS PATH?

425

MR. WADE: AND DO YOU RECALL WHAT DEPARTMENT THEY WERE IN?

426

ADAM ROSENDORFF: WHAT DEPARTMENT?

427

MR. WADE: YEAH. YOU SEE THE PATH THAT'S OUTLINED IN THIS?

429

MR. WADE: AND YOU WORKED IN THAT BUILDING?

431

MR. WADE: IN WHAT DEPARTMENT WERE THOSE WHITE BOARDS?

432

ADAM ROSENDORFF: I CAN TELL YOU WHERE THEY WERE SITUATED. THEY WERE SITUATED ON A WALL AND BEHIND THE WALL WAS A CORRIDOR AND BEHIND THE CORRIDOR WAS THE JURASSIC PARK LABORATORY.

433

MR. WADE: OKAY. SO IT'S THE JURASSIC PARK LABORATORY?

435

MR. WADE: AND DO YOU RECALL WHO USED THE WHITE BOARDS?

436

ADAM ROSENDORFF: THE INTENTION OF THE WHITE BOARDS WAS TO SHOW LICENSING OR PERSONNEL. SO OUR CLIA LICENSE WE PINNED UP THERE, OUR CLS LICENSES WE PINNED UP THERE, THE NEW YORK LICENSES, OTHER STATE LICENSES.

437

MR. WADE: OKAY. YOU DON'T THINK IT WAS ANYTHING CONFIDENTIAL?

439

MR. WADE: OKAY. SO ANYONE COULD HAVE LOOKED AT THE MATERIAL IN YOUR MIND?

440

ADAM ROSENDORFF: COULD YOU CLARIFY THE QUESTION?

441

MR. WADE: WELL, YOU WOULDN'T HAVE HAD A PROBLEM SHOWING THAT TO ANYONE COMING IN?

443

MR. WADE: OKAY. LET'S FOCUS ON THE SECOND PARAGRAPH. OKAY, SIR?

445

MR. WADE: LET'S BLOW THAT UP IF WE CAN. IT SAYS, "I WOULD SUGGEST THAT THE PATH TO THE NORMANDY LAB BE THE STAIRS BY THE BACK DOOR AND WALK THROUGH THE SHIPPING AREA OR USE THE ELEVATOR IF ANYONE HAS PHYSICAL PROBLEMS PREVENTING THEM FROM USING THE STAIRS." DO YOU SEE THAT?

447

MR. WADE: SHE'S TALKING ABOUT THE ACTUAL PATH THAT YOU WOULD TAKE TO THE NORMANDY LAB?

448

ADAM ROSENDORFF: SHE'S SUGGESTING A PATH TO THE NORMANDY LAB.

449

MR. WADE: IN RESPONSE TO MS. HOLMES'S INQUIRY; RIGHT?

451

MR. WADE: AND YOU WERE SHOWN THIS DOCUMENT BY THE GOVERNMENT IN YOUR PREPARATION, WERE YOU NOT?

452

ADAM ROSENDORFF: I DO NOT RECALL.

453

MR. WADE: OKAY. IF YOU CAN LOOK IN YOUR YELLOW BINDER AT TX 11 --

454

ADAM ROSENDORFF: WHICH VOLUME, SIR?

455

MR. WADE: VOLUME 2 --

457

MR. WADE: -- EXHIBIT 11424 --

459

MR. WADE: -- PAGE 10?

461

MR. WADE: AND IF YOU COULD LOOK AT THE LARGE PARAGRAPH IN THE MIDDLE AND JUST READ IT TO YOURSELF AND TELL ME WHEN YOU'RE DONE.

462

(PAUSE IN PROCEEDINGS.)

463

ADAM ROSENDORFF: OKAY. I'VE READ IT.

464

BY MR. WADE:

465

MR. WADE: AND FOR THE RECORD, THIS IS -- I'M SHOWING YOU A MEMORANDUM OF INTERVIEW THAT RELATES TO YOUR AUGUST 30TH INTERVIEW A COUPLE WEEKS AGO; RIGHT?

467

MR. WADE: OKAY. AND HAVE YOU READ THAT?

469

MR. WADE: OKAY. DOES READING THAT REFRESH YOUR RECOLLECTION THAT THE GOVERNMENT SHOWED YOU THIS DOCUMENT IN THAT INTERVIEW?

470

ADAM ROSENDORFF: NOT THE DOCUMENT FROM KERRY. THE OTHER TWO, YES. I DON'T SEE MENTION OF THE DOCUMENT FROM KERRY, THE EMAIL FROM KERRY.

471

MR. WADE: LET'S BLOW UP THE BATES NUMBER IN THE BOTTOM CORNER, PLEASE. YOU THINK YOU WERE JUST SHOWN THE DOCUMENT FROM KERRY AND NOT THIS DOCUMENT?

472

ADAM ROSENDORFF: NO. I THINK I WAS JUST SHOWN THE DOCUMENT FROM MS. HOLMES ABOUT DELINEATION OF THE PATH, AND THEN THE OTHER EMAIL FROM MS. HOLMES THAT SAYS KERRY, PLEASE DELINEATE. I DON'T RECALL THAT I SAW KERRY'S RESPONSE DURING THAT GOVERNMENT SESSION.

473

MR. WADE: THE GOVERNMENT NEVER SHOWED YOU THAT RESPONSE?

474

ADAM ROSENDORFF: I DON'T RECALL SEEING IT.

475

MR. WADE: OKAY. WELL, DOES THIS -- DO THESE DOCUMENTS REFRESH YOUR RECOLLECTION THAT YOU BELIEVE THAT MS. HOLMES WAS OPEN TO SHOWING THE AUDITORS THE DOWNSTAIRS LAB?

476

ADAM ROSENDORFF: YES, THAT IS WHAT I TOLD THE GOVERNMENT DURING THIS INTERVIEW.

477

MR. WADE: AND PART OF THE REASON, SIR, WHY THERE NEEDED TO BE SOME DISCUSSION ABOUT THESE LABS WAS BECAUSE THE THERANOS LAB WAS SPLIT INTO TWO DIFFERENT PHYSICAL LOCATIONS; RIGHT?

479

MR. WADE: AND --

480

ADAM ROSENDORFF: SAME BUILDING.

481

MR. WADE: IN THE SAME BUILDING, BUT ONE WAS IN THE BASEMENT; CORRECT?

483

MR. WADE: OKAY. AND YOU BELIEVED, SIR, THAT THE R&D SECTION SHOULD HAVE BEEN AVOIDED DURING THAT, DURING THAT INTERVIEW; RIGHT? OR DURING THAT INSPECTION; CORRECT?

484

ADAM ROSENDORFF: THE INSPECTORS WOULD NOT HAVE ASKED TO SEE AN R&D AREA. IT'S NOT USED FOR PROCESSING PATIENT SAMPLES. THERE'S NO REASON WHY THEY WOULD NEED TO SEE IT, YEAH.

485

MR. WADE: BUT YOU BELIEVED IT SHOULD HAVE BEEN AVOIDED; RIGHT?

486

ADAM ROSENDORFF: IF THE INSPECTORS HAD SPECIFICALLY ASKED TO SEE IT, I WOULD HAVE SHOWN IT TO THEM.

487

MR. WADE: FAIR ENOUGH. BECAUSE YOU WERE ALWAYS TRANSPARENT WITH THE INSPECTORS; CORRECT?

489

MR. WADE: BUT DO YOU RECALL TELLING THE GOVERNMENT IN THAT SAME INTERVIEW THAT YOU THOUGHT IT WAS REASONABLE TO AVOID THE R&D LAB UNLESS THEY REQUESTED IT?

491

MR. WADE: AND DURING THAT INSPECTION, THOSE INSPECTORS WERE SHOWN WHATEVER THEY WANTED TO SEE?

493

MR. WADE: AND THEY DIDN'T ASK TO SEE THE LABORATORY THAT INCLUDED THE LDT'S; RIGHT?

494

ADAM ROSENDORFF: NO, NOT EXPLICITLY, NO.

495

MR. WADE: AND IF THEY HAD, YOU WOULD HAVE SHOWN IT TO THEM?

497

MR. WADE: YOU ACTUALLY -- YOU TOLD THE INSPECTORS ABOUT THE DOWNSTAIRS LAB; RIGHT?

499

MR. WADE: DO YOU RECALL GIVING TESTIMONY PREVIOUSLY THAT YOU TOLD THE INSPECTORS OF THE DOWNSTAIRS LAB?

500

ADAM ROSENDORFF: I DON'T RECALL.

501

MR. WADE: LET'S TAKE A LOOK AT EXHIBIT 11001, WHICH IS IN YOUR YELLOW BINDER, VOLUME 1.

503

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

505

MR. WADE: OKAY. IF YOU COULD LOOK AT PAGE 47, LINES -- I'M SORRY, PAGE 41, LINES 17 TO 21. PAGE 41, LINES 17 TO 21. READ IT TO YOURSELF, PLEASE.

507

MR. WADE: AND DOES THAT REFRESH YOUR RECOLLECTION, SIR, THAT YOU TOLD THE INSPECTORS ABOUT THE DOWNSTAIRS LAB?

508

ADAM ROSENDORFF: NO. I MEAN, I STATE IN THIS INTERVIEW WE TOLD HER, AND THEN I HESITATE, AND I SAY WE MUST HAVE TOLD HER. I WAS -- THIS WAS MORE IN THE VEIN OF SPECULATION. I DO RECALL SPECIFICALLY DURING THE AUDITS I SENT AN EMAIL TO DANIEL YOUNG SAYING, BASICALLY SHOULD WE TELL THE INSPECTORS ABOUT THE DOWNSTAIRS LAB? AND DANIEL YOUNG SAID NOT UNLESS SHE EXPLICITLY ASKS ABOUT IT. YOU KNOW, I'M SAYING WE MUST HAVE TOLD HER. THAT'S A, I GUESS YOU WOULD CALL IT AN INFERENCE OR A LOGICAL CONCLUSION, NOT REALLY A RECOLLECTION. YEAH.

509

MR. WADE: YOU WERE INFERRING FROM THE CIRCUMSTANCES RELATING TO YOUR INTERACTIONS WITH THE INSPECTOR THAT YOU MUST HAVE SHOWN HER OR TOLD HER ABOUT THE DOWNSTAIRS LAB?

510

ADAM ROSENDORFF: I DO -- I DON'T REMEMBER WHAT THE BASIS OF MY INFERENCE WAS DURING THIS TESTIMONY WITH COLMAN.

511

MR. WADE: BUT YOU CERTAINLY DIDN'T HIDE THE DOWNSTAIRS LAB FROM THEM; RIGHT?

512

ADAM ROSENDORFF: AGAIN, IF THEY HAD ASKED TO SEE ABOUT THE DOWNSTAIRS LAB, IF THEY HAD ASKED TO SEE WHERE THESE LDT'S WERE PERFORMED, I WOULD HAVE BEEN OBLIGED TO SHOW THE DOWNSTAIRS LAB TO THEM.

513

MR. WADE: I JUST WANT TO MAKE SURE THE RECORD IS CLEAR. IS IT YOUR TESTIMONY THAT YOU ACTIVELY CONCEALED THAT LABORATORY FROM THEM?

515

MR. WADE: OKAY. YOU DIDN'T HIDE IT FROM THEM; RIGHT?

517

MR. WADE: AND DURING THIS SURVEY THERE WERE A FEW DEFICIENCIES AND AREAS OF IMPROVEMENT THAT WERE NOTED BY THE INSPECTOR; RIGHT?

519

MR. WADE: AND THEY WERE RELATIVELY MINOR ISSUES?

521

MR. WADE: OKAY. AND IS THAT IN PART BECAUSE YOU HAD DONE ALL OF THAT PREPARATION WORK IN ADVANCE?

522

ADAM ROSENDORFF: IN PART, YES.

523

MR. WADE: OKAY. DO YOU RECALL THAT NEVERTHELESS MS. HOLMES AND MR. BALWANI WERE UPSET THAT THERE WERE ANY DEFICIENCIES?

525

MR. WADE: AND THEY WANTED TO DO BETTER; RIGHT?

526

ADAM ROSENDORFF: THEY WANTED NO DEFICIENCIES ON THE REPORT.

527

MR. WADE: AND I ASSUME YOU WOULD HAVE WANTED NO DEFICIENCIES ON THE REPORT; RIGHT?

528

ADAM ROSENDORFF: WELL, THAT'S IDEAL, YES.

529

MR. WADE: BUT IT'S NOT COMMON, IS IT?

530

ADAM ROSENDORFF: IT HAPPENS.

531

MR. WADE: USUALLY THEY FIND SOME DEFICIENCIES THAT THEY DOCUMENT IN THE REPORT; RIGHT?

533

MR. WADE: AND THESE WERE, IN YOUR MIND, RELATIVELY MINOR DEFICIENCIES?

535

MR. WADE: AND YOU ADDRESSED THEM QUICKLY?

537

MR. WADE: AND YOU MOVED ON WITH A CLEAN BILL OF HEALTH; RIGHT?

540

(PAUSE IN PROCEEDINGS.)

541

BY MR. WADE:

542

MR. WADE: I'M GOING TO SWITCH TOPICS HERE, DR. ROSENDORFF. IF WE CAN START BY PULLING UP EXHIBIT 12464, WHICH IS IN EVIDENCE, AND WE DISCUSSED YESTERDAY JUST TO KIND OF REORIENT YOU TO WHERE WE ARE. THIS IS THE NOVEMBER 8TH, 2013 EMAIL FROM YOU TO MR. BALWANI. DO YOU SEE THAT?

544

MR. WADE: AND IF WE CAN GO TO THE BOTTOM OF THAT EMAIL, DOWN ON THE BOTTOM, MR. BALWANI'S EMAIL. AND DO YOU RECALL THIS WAS THE EMAIL IN WHICH MR. BALWANI MADE INQUIRIES OF YOU IN ADVANCE OF THE PUBLIC LAUNCH OF OPERATIONS AT WALGREENS?

545

ADAM ROSENDORFF: I RECALL READING THIS EMAIL YESTERDAY.

546

MR. WADE: OKAY. AND LET ME GO TO THE SECOND PAGE AGAIN JUST SO I CAN REFRESH YOU ON THE TOPICS THAT WE WANT TO DISCUSS. OKAY. AND YOU RECALL HERE MR. BALWANI ASKING YOU IF THERE'S ANYTHING YOU NEEDED OR ANYTHING THAT NEEDED TO BE ADDRESSED IN ADVANCE OF THAT LAUNCH AT WALGREENS. DO YOU RECALL THAT?

548

MR. WADE: OKAY. DO YOU RECALL THAT YOU DID SOME WORK IN CONNECTION WITH THAT TO MAKE SURE THAT THE LAB WAS IN SHAPE IN ADVANCE OF THAT PUBLIC LAUNCH; RIGHT?

550

MR. WADE: OKAY. AND YOU HAD RAISED SOME ISSUES UP THE CHAIN OF THIS EMAIL THAT YOU WANTED TO ADDRESS. DO YOU RECALL THAT? I DON'T HAVE ANY SPECIFIC QUESTIONS. DO YOU RECALL GENERALLY THAT YOU RAISED SOME ISSUES THAT YOU WANTED TO ADDRESS BEFORE THE OPENING?

551

ADAM ROSENDORFF: THIS IS A NOVEMBER EMAIL THAT WE'RE LOOKING AT?

552

MR. WADE: YEAH. WE CAN --

553

ADAM ROSENDORFF: LET'S STEP BACK.

554

MR. WADE: LET'S PULL THE EMAIL UP, THE DATE UP. LET'S PULL THE TOP. DO YOU SEE THIS WAS NOVEMBER 8TH, 2013?

555

ADAM ROSENDORFF: OKAY. AND WHAT IS MY RESPONSE TO THIS EMAIL?

556

MR. WADE: YOUR RESPONSE IS RIGHT THERE ABOUT HOW YOU'RE EXCITED.

557

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

558

MR. WADE: AND YOU RAISE SOME ISSUES THAT YOU WANTED TO ADDRESS IN RESPONSE TO HIS INQUIRY; RIGHT?

560

MR. WADE: AND THIS IS ON FRIDAY, NOVEMBER 8TH. DO YOU SEE THAT?

562

MR. WADE: AND I'D LIKE TO GO TO EXHIBIT 1240.

563

MR. WADE: THE COURT'S INDULGENCE.

564

(PAUSE IN PROCEEDINGS.)

565

MR. WADE: MAY I APPROACH, YOUR HONOR?

567

BY MR. WADE:

568

MR. WADE: DO YOU HAVE 1240 IN FRONT OF YOU?

570

MR. WADE: AND IF YOU CALL YOUR ATTENTION TO THE BOTTOM OF THE EMAIL CHAIN, DO YOU SEE THAT THIS IS AN EMAIL BETWEEN YOU AND MR. BALWANI?

572

MR. WADE: REGARDING LAB COMPLIANCE?

574

MR. WADE: I MOVE THE ADMISSION OF 1240.

575

MR. BOSTIC: NO OBJECTION. IT'S ADMITTED, AND IT MAY BE PUBLISHED.

576

(GOVERNMENT'S EXHIBIT 1240 WAS RECEIVED IN EVIDENCE.)

577

BY MR. WADE:

578

MR. WADE: IF WE CAN START ON THE BOTTOM EMAIL AND WORK OUR WAY UP HERE?

580

MR. WADE: OKAY. DO YOU SEE -- NOW, THIS IS AN EMAIL THAT IS ON SUNDAY, NOVEMBER 10TH, 2013. DO YOU SEE THAT?

582

MR. WADE: AND THIS IS JUST SHORTLY AFTER MR. BALWANI SENT YOU THAT EMAIL SAYING, IS THERE ANYTHING THAT WE NEED? DO YOU RECALL THAT?

584

MR. WADE: AND IT LOOKS LIKE YOU WENT TO WORK TO MAKE SURE THAT EVERYTHING WAS IN SHAPE; RIGHT?

586

MR. WADE: AND IT LOOKS LIKE YOU WERE WORKING OVER THE WEEKEND; RIGHT?

588

MR. WADE: BECAUSE THIS EMAIL WAS SENT ON A SUNDAY?

589

ADAM ROSENDORFF: I WAS VERY -- I WAS THINKING VERY HARD ABOUT COMPLIANCE AND QUALITY ISSUES OVER THE WEEKEND, YEAH.

590

MR. WADE: RIGHT. BECAUSE IF YOU WERE GOING TO OPEN UP TO THE GENERAL PUBLIC, YOU WANTED TO MAKE DOUBLY SURE THAT EVERYTHING WAS IN SHAPE ON COMPLIANCE; RIGHT?

591

ADAM ROSENDORFF: CORRECT. CORRECT.

592

MR. WADE: AND IN GOING THROUGH THOSE ISSUES, YOU IDENTIFIED, YOU IDENTIFIED SOME ITEMS THAT YOU WANTED TO FLAG FOR MR. BALWANI; CORRECT?

594

MR. WADE: AND SPECIFICALLY YOU MENTIONED COMPLIANCE WITH FEDERAL LAW CFR 493.1253. DO YOU SEE THAT?

596

MR. WADE: THAT'S IN THE SUBJECT MATTER OF THE EMAIL THERE. DO YOU SEE THAT?

598

MR. WADE: AND THAT'S ONE OF THOSE REGULATIONS THAT IS WITHIN EXHIBIT 7603 THAT WE WERE TALKING ABOUT YESTERDAY; RIGHT?

600

MR. WADE: AND SO YOU WERE GOING THROUGH AND MAKING SURE THAT EVERYTHING WAS TICKED AND TIED; RIGHT?

602

MR. WADE: AND SO WHEN YOU DID THAT, YOU IDENTIFIED AN ISSUE IN CONNECTION WITH THE ESTABLISHMENT AND VERIFICATION OF PERFORMANCE SPECIFICATIONS; RIGHT?

604

MR. WADE: AS YOU WERE WORKING YOUR WAY THROUGH -- AND IF WE CAN BLOW UP THE LOWER PART OF THE EMAIL BEFORE -- BELOW THAT FROM 493.1253 DOWN TO THE BOTTOM. AND AS YOU WERE DOING YOUR WORK, YOU WERE GOING THROUGH THESE ITEMS RELATING TO ACCURACY AND PRECISION AND THE REPORTABLE RANGE AND THE LIKE; RIGHT?

606

MR. WADE: TO MAKE SURE YOU WERE IN COMPLIANCE?

608

MR. WADE: AND THERE WAS AN ITEM DOWN THERE AT THE BOTTOM, DO YOU SEE THAT, RELATING TO THE REPORTABLE RANGE OF TEST RESULTS FOR THE TEST SYSTEM?

610

MR. WADE: AND YOU HIGHLIGHTED, YOU HIGHLIGHTED FOR MR. BALWANI THAT YOU HAD A CONCERN ABOUT THAT; RIGHT?

612

MR. WADE: AND LET'S GO TO THE NEXT PAGE OF THAT EMAIL AND JUST BLOW UP THE WHOLE EMAIL. OKAY. AND YOU SAY, "MY CONCLUSIONS AND INTERPRETATIONS OF THE ABOVE," AND YOU IDENTIFY TWO ITEMS RELATING TO THE REGULATIONS THAT YOU THOUGHT NEEDED TO BE APPLIED?

614

MR. WADE: CORRECTED; CORRECT?

616

MR. WADE: OKAY. AND YOU SENT THAT TO YOUR BOSS?

618

MR. WADE: MR. BALWANI. AND, AGAIN, THIS IS TWO DAYS AFTER HE MADE THAT INQUIRY OF YOU; RIGHT?

620

MR. WADE: OKAY. AND IF WE CAN GO UP THE CHAIN TO THE NEXT EMAIL. YOU ADDED ONE ADDITIONAL COMMENT THERE. YOU SAID, "SUNNY. "SORRY I ALSO FORGOT TO MENTION, THAT SPECIFICITY STUDIES ARE MISSING FOR A NUMBER OF GC ANALYTES." DO YOU SEE THAT?

622

MR. WADE: AND LET'S GO UP THE CHAIN AND, ON THE BOTTOM PAGE THERE, LET'S LOOK AT THE NEXT COUPLE OF EMAILS. WE'LL WORK UP FROM THE BOTTOM. DO YOU SEE MR. BALWANI ASKS, "WHAT GC ASSAYS?" DO YOU SEE THAT?

624

MR. WADE: AND THEN YOU IDENTIFY THAT YOU'RE GOING THROUGH THEM NOW?

626

MR. WADE: AND, AGAIN, THIS IS SUNDAY AFTERNOON?

628

MR. WADE: AND YOU ARE WORKING HARD.

629

ADAM ROSENDORFF: I'M TRYING TO GET THE LAB TO COME INTO COMPLIANCE.

630

MR. WADE: RIGHT. AND YOU'RE RAISING THE ISSUES AND MAKING SURE THAT PEOPLE KNOW THAT THEY NEED TO BE ADDRESSED; RIGHT?

632

MR. WADE: THAT'S YOUR JOB?

634

MR. WADE: OKAY. AND YOU RAISE THE SPECIFIC ITEMS THAT ARE MENTIONED THERE; RIGHT?

636

MR. WADE: OKAY. AND LET'S LOOK AT MR. BALWANI'S RESPONSE. OKAY. SO HE RESPONDS, "MY COMMENTS BELOW." HE CONSULTED WITH THE OTHER TEAM LEADS IN THE OFFICE TODAY ON THIS, SO THIS IS AUTHORITATIVE. AND HE IDENTIFIES -- HE PROVIDES YOU INFORMATION THAT HE THINKS IS A RESPONSE TO THE INQUIRY THAT YOU MADE OF HIM; RIGHT?

638

MR. WADE: AND IF YOU LOOK AT THE TWO PARAGRAPHS AT THE BOTTOM -- ACTUALLY, IF WE CAN ZOOM OUT AND THEN JUST BLOW THOSE TWO PARAGRAPHS UP. HE TALKS ABOUT THE GC PROCEDURES AND HOW EVERYONE IS FOLLOWING THIS PROCESS RELIGIOUSLY. IF IT'S NOT IN THE SOP'S, THEN I WILL MAKE SURE THIS GETS THERE TOMORROW. DO YOU SEE THAT?

640

MR. WADE: AND REGARDING THE EDISON, THE QC PROCEDURES WERE WORKED OUT AND COMMUNICATED TO THE CLIA TEAM. HE SAYS, I'M STILL WORKING WITH THE ELISA TEAM TO ESTABLISH THE ACCEPTABLE QC FOR THE EDISONS. DO YOU SEE THAT?

642

MR. WADE: AND THEN HE TALKS ABOUT THE NEXT STEP WAS TO DOCUMENT THESE PROCEDURES IN SOP'S IN CLIA APPROVED AND RELEASED PROTOCOLS, TRAIN THE STAFF, AND HAVE THEM IMPLEMENT THESE PROCEDURES; RIGHT?

644

MR. WADE: AND HE NOTES THAT HE TALKED TO KERRY ABOUT THAT A COUPLE WEEKS AGO; RIGHT?

646

MR. WADE: OKAY. SO HE'S SUGGESTING LET'S GET TO IT; RIGHT?

648

MR. WADE: LET'S WORK UP THE CHAIN. AND THEN WE HAVE TO GO A COUPLE PAGES UP BECAUSE THERE'S A LONG LIST. OKAY. LET'S START THERE. AND YOU SAY, "HI SUNNY. THANKS FOR YOUR COMMENTS." DO YOU SEE THAT?

650

MR. WADE: AND THEN YOU SAY, "IN TERMS OF SPECIFICITY, THE FOLLOWING HAVE NOT BEEN DONE." THIS WAS IN RESPONSE TO HIS INQUIRY ON THE GENERAL CHEMISTRY ASSAYS THAT NEEDED MORE SPECIFICITY INFORMATION; RIGHT?

652

MR. WADE: AND YOU RAISED THE SPECIFICITY ISSUE; RIGHT?

654

MR. WADE: AND THEN HE ASKED YOU WHICH ASSAYS?

656

MR. WADE: AND THIS IS THE RESPONSE; RIGHT? AND YOU IDENTIFY A LIST OF THEM THAT NEED A RESPONSE; RIGHT?

657

ADAM ROSENDORFF: I CAN ELABORATE ON THAT IF NEED BE.

658

MR. WADE: AT AN APPROPRIATE POINT MAYBE. BUT I JUST WANT TO MAKE SURE THAT I GET MY QUESTIONS OUT THERE.

659

ADAM ROSENDORFF: SURE. I'M JUST READING EMAILS THAT YOU'RE SHOWING ME AND I'M SAYING YES, I'M READING THIS EMAIL AND THAT'S WHAT IS GOING ON HERE.

660

MR. WADE: AND I'M JUST TRYING TO MAKE SURE THAT I UNDERSTAND THAT I'M READING THIS EMAIL RIGHT. YOU WROTE THE EMAIL. YOU SENT THESE COMMENTS TO MR. BALWANI; RIGHT?

662

MR. WADE: AND THEN YOU IDENTIFIED A LIST OF THE ISSUES; CORRECT?

664

MR. WADE: AND IF WE GO ON -- IF WE ZOOM OUT AND GO TO THE NEXT PAGE, THE NEXT PAGE GOING BACKWARD. YOU PROVIDE THE WHOLE LIST; RIGHT?

666

MR. WADE: OKAY. AND YOU SEND THAT TO HIM ON SUNDAY AFTERNOON?

668

MR. WADE: OKAY. AND IF WE GO UP THE CHAIN TO THE NEXT EMAIL, MR. BALWANI SAYS, "ADAM. AS YOU KNOW, WE TAKE THESE ISSUES WITH SERIOUSNESS. WHY DIDN'T YOU RAISE THESE BEFORE TO ME WHEN I WAS ASKING FOR ANY ISSUES FOR MONTHS? IT WAS ONLY A MONTH PLUS AGO WHEN YOU SIGNED OFF ON THESE ASSAYS. SAME THING AROUND ULOQ. THIS IS WHY WE MEET EVERY WEEK AND I HAVE PROACTIVELY SEEKING OUT ANY CONCERNS FOR EVERY MEMBER THROUGHOUT THE COMPANY." DO YOU SEE WHAT HE WROTE THERE?

669

ADAM ROSENDORFF: YES, I SEE WHAT HE WROTE.

670

MR. WADE: AND THEN HE SAYS HE WILL CIRCLE BACK WITH OTHER TEAM MEMBERS AND GET THEIR RESPONSES. DO YOU SEE THAT?

672

MR. WADE: AND SO HE WAS FRUSTRATED IN THAT EMAIL; RIGHT?

673

ADAM ROSENDORFF: YOU'RE DRAWING THAT INFERENCE.

674

MR. WADE: WOULD YOU DRAW THAT INFERENCE FROM THAT EMAIL, OR DO YOU THINK HE WAS NOT FRUSTRATED?

675

ADAM ROSENDORFF: HE'S ASKING ME WHY I DIDN'T RAISE THESE ISSUES BEFORE.

676

MR. WADE: OKAY. AND YOU RESPONDED, DIDN'T YOU? LET'S LOOK AT YOUR RESPONSE. YOU APOLOGIZE FOR THE LATE FEEDBACK REGARDING READINESS; RIGHT?

678

MR. WADE: YOU HAD BEEN WORKING HARD; RIGHT?

680

MR. WADE: BUT IT WASN'T GOING TO STOP YOU FROM RAISING AN ISSUE EVEN IF YOU SAW IT AT THE LAST MINUTE; RIGHT?

682

MR. WADE: AND THAT'S WHAT YOU'RE DOING IN THIS EMAIL?

684

MR. WADE: AND YOU NOTE THAT IT TAKES YOU A LITTLE TIME TO SEE THE WHOLE PICTURE; RIGHT?

686

MR. WADE: THESE LABS ARE COMPLICATED?

687

ADAM ROSENDORFF: VERY COMPLICATED.

688

MR. WADE: SOMETIMES THEY'RE HARD TO UNDERSTAND THE INFORMATION AND THE -- ALL OF THE DOCUMENTS UNTIL YOU'VE HAD A LITTLE TIME TO DIGEST THEM; RIGHT?

689

ADAM ROSENDORFF: WELL, YOU HAVE TO SQUARE UP THE REGULATIONS WITH THE STUDIES THAT HAVE BEEN DONE AND MAKE SURE THEY MATCH UP WITH EACH OTHER, YEAH.

690

MR. WADE: RIGHT.

691

ADAM ROSENDORFF: THAT TAKES TIME.

692

MR. WADE: THAT TAKES TIME. YOU WOULD TAKE THIS STUDY AND COMPARE IT TO THOSE REGULATIONS IN EXHIBIT 7603, AND YOU MAKE SURE THAT EVERYTHING IS COMPLIANT; RIGHT?

694

MR. WADE: AND YOU HAD TO DO THAT; RIGHT?

696

MR. WADE: BECAUSE THAT WAS YOUR RESPONSIBILITY; RIGHT?

698

MR. WADE: YOU WERE SIGNING YOUR NAME ON THAT DOCUMENT?

700

MR. WADE: OKAY. AND SO EVEN THOUGH IT TOOK A LITTLE BIT OF TIME, YOU WANTED TO DO IT; RIGHT?

702

MR. WADE: OKAY. AND THAT'S WHAT YOU'RE DOING HERE; CORRECT?

704

MR. WADE: AND THEN YOU EXPLAIN THAT THE SPECIFICITY STUDIES WERE ADDED TO SOME OF THE VALIDATION REPORTS AFTER YOUR SIGNATURE AND SO YOU JUST WANTED TO GO THROUGH THEM AGAIN; RIGHT?

705

ADAM ROSENDORFF: THEY SHOULD HAVE BEEN RECORDED AS REVISIONS TO THE VALIDATION WITH THE DATE THAT THE REVISION WAS MADE. THEY SHOULD HAVE BEEN DONE IDEALLY BEFORE, YOU KNOW, BEFORE PROCESSING PATIENT SPECIMENS. I DON'T KNOW WHEN -- YEAH. SO WHEN WAS THE WIDER LAUNCH? NOVEMBER 11TH YOU SAID?

706

MR. WADE: WELL, IT WAS AFTER THIS DATE BECAUSE HE SENT YOU THE EMAIL ON FRIDAY; RIGHT?

708

MR. WADE: AND THIS WAS ON SUNDAY; CORRECT?

709

ADAM ROSENDORFF: I JUST WANT TO ADD THAT THE THERANOS TECHNOLOGY DID NOT ALLOW FOR THE DETECTION OF INTERFERING SUBSTANCES. SO EVEN IF WE HAD DONE THE STUDY AS REQUIRED BY LAW, THE TECHNOLOGY ITSELF WOULD NOT HAVE ALLOWED FOR THE DETECTION OF THOSE INTERFERING SUBSTANCES.

710

MR. WADE: OKAY. WHAT I'M WANTING TO FOCUS ON IS SPECIFICALLY THIS EMAIL, WHICH IS YOU'RE LOOKING AT THOSE VALIDATION STUDIES; RIGHT?

712

MR. WADE: AND YOU'RE LOOKING AT THOSE REGULATIONS; RIGHT?

714

MR. WADE: AND YOU'RE WANTING TO MAKE SURE THAT THEY ARE, THEY ARE COMPLIANT; CORRECT?

716

MR. WADE: AND IF THERE'S A CONCERN, YOU WANT TO TRY TO ADDRESS IT, AND THAT'S WHAT YOU'RE DOING RIGHT HERE; RIGHT?

718

MR. WADE: OKAY. AND YOU MENTIONED THAT YOU THOUGHT IT WAS DIFFICULT TO GET SOME ANSWERS FROM DANIEL'S TEAM ON A TIMELY BASIS?

720

MR. WADE: AND THAT WAS ONE OF THE REASONS FOR THE DELAY; RIGHT?

722

MR. WADE: BUT YOU WENT IN ON SUNDAY, AND YOU WORKED TO GET IT DONE?

724

MR. WADE: OKAY. LET'S WORK UP THE CHAIN. LET'S GO TO MR. BALWANI'S RESPONSE AT THE BOTTOM. DO YOU SEE THAT?

726

MR. WADE: OKAY. AND IT SAYS, "IF THE SPECIFICITY STUDIES ARE NOT REQUIRED (AND HENCE WERE TO BE DONE AS REVISIONS) THEN THAT'S WHEN WE SHOULD DO AND NOT HAVE THEM HOLD BACK WHAT WE ARE DOING." DO YOU SEE THAT?

727

ADAM ROSENDORFF: YES, I SEE THAT.

728

MR. WADE: I THINK THERE'S A LITTLE GRAMMATICAL ISSUE THERE, BUT HE'S ESSENTIALLY SAYING IF THEY'RE NOT REQUIRED, LET'S JUST GO AHEAD AND KIND OF CLEAN IT UP LATER?

729

ADAM ROSENDORFF: BUT THEY ARE REQUIRED.

730

MR. WADE: WELL, LET'S LOOK AT YOUR RESPONSE. YOU ACTUALLY SAY JUST THAT, DON'T YOU?

732

MR. WADE: AND YOU SAY THEY ARE REQUIRED. THEY'RE VERY IMPORTANT IN FACT YOU NOTE; RIGHT?

734

MR. WADE: BECAUSE YOU HAD READ THOSE REGULATIONS?

736

MR. WADE: OKAY. AND YOU ACTUALLY NOTE THAT THERE IN THE SECOND LINE THERE, "IT IS ESSENTIAL TO PROVE THAT IT DOESN'T INTERFERE WITH THE MODIFIED ASSAY." RIGHT?

738

MR. WADE: AND YOU DEEMED IT AS ESSENTIAL?

740

MR. WADE: AND THAT'S WHY YOU'RE RAISING IT?

742

MR. WADE: AND THAT'S WHY YOU'RE NOT LETTING HIM GO FORWARD --

744

MR. WADE: -- BECAUSE IT'S YOUR JOB; RIGHT?

745

ADAM ROSENDORFF: I HAD MANY, MANY BATTLES WITH SUNNY ABOUT WHAT WAS NEEDED VERSUS WHAT HE WAS PREPARED TO ALLOW IN TERMS OF THE R&D GROUP ACTUALLY DOING THE WORK.

746

MR. WADE: RIGHT. BUT FUNDAMENTALLY, IT'S NOT MR. BALWANI WHO IS PUTTING HIS NAME, HIS SIGNATURE ON THOSE DOCUMENTS; RIGHT?

747

ADAM ROSENDORFF: NO. THAT'S WHY I -- THAT'S WHY I -- THAT'S WHY I HAD BATTLES WITH HIM.

748

MR. WADE: AND THAT'S WHY YOU RAISED THE ISSUE HERE; RIGHT?

750

MR. WADE: OKAY. LET'S GO UP THE CHAIN. LET'S LOOK AT MR. BALWANI'S RESPONSE. OKAY. HE SAYS HE SPOKE WITH THE TEAMS TODAY, AND THEY ARE ALL GOING TO PUT LONG HOURS IN AND DO WHATEVER IT TAKES TO GET THIS DONE TOMORROW. DO YOU SEE THAT?

752

MR. WADE: AND HE SAYS, "WE ALREADY HAVE ALL OF THE DATA, THEY WILL COMPLETE THE REPORTS." DO YOU SEE THAT?

754

MR. WADE: AND HE SAYS, "PLEASE SPEND TIME ON THIS AND HIGHLIGHT IF THERE IS ANYTHING MISSING." DO YOU SEE THAT?

756

MR. WADE: "WE DON'T WANT TO GO THRU THIS AGAIN." DO YOU SEE THAT?

758

MR. WADE: AND HE IS SAYING KEEP DOING YOUR WORK AND RAISE IT AS QUICKLY AS YOU CAN; RIGHT? HE WAS COMPLAINING A LITTLE ABOUT THE TIMING MAYBE?

760

MR. WADE: AND LET'S LOOK AT YOUR RESPONSE. YOU SAY, "WILL DO." RIGHT?

762

MR. WADE: OKAY. AND IF WE JUST GO TO THE TOP EMAIL, THIS IS YOUR EFFORTS TO RAISE THIS ISSUE AND ENSURE COMPLIANCE AND THE FOLLOWUP THAT WAS NEEDED WAS COMMUNICATED TO MS. HOLMES; CORRECT?

764

MR. WADE: THE -- WE TALKED YESTERDAY ABOUT HOW THERANOS HAD A DETAILED QC PLAN; RIGHT? DO YOU RECALL THAT?

765

ADAM ROSENDORFF: WE REVIEWED THE QUALITY MANAGEMENT SYSTEMS MANUAL.

766

MR. WADE: CORRECT. AND DO YOU RECALL THAT THERE WERE ALSO SOME PROCEDURES THAT RELATED SPECIFICALLY -- WELL, LET ME STRIKE THAT. AND THAT GENERALLY SET FORTH THE WHOLE -- THE QUALITY SYSTEMS PROGRAM FOR THE WHOLE COMPANY; RIGHT?

767

ADAM ROSENDORFF: FOR THE LABORATORY SPECIFICALLY.

768

MR. WADE: FAIR POINT. IT DIDN'T COVER THE ACCOUNTING FUNCTION OF THE COMPANY?

770

MR. WADE: OR THE PARKING REGULATIONS. IT FOCUSSED ON THE LAB; RIGHT?

772

MR. WADE: AND THAT WAS AN OVERARCHING QUALITY ASSURANCE SYSTEM THAT WAS DESIGNED TO MAKE SURE THAT THE LAB WAS COMPLIANT WITH FEDERAL CLIA REGULATIONS. DO YOU RECALL THAT?

774

MR. WADE: AND WE LOOKED AT THAT POLICY YESTERDAY THAT YOU SIGNED; RIGHT?

775

ADAM ROSENDORFF: YES, WE DID.

776

MR. WADE: AND I BELIEVE IT WAS DEVELOPED BY --

777

ADAM ROSENDORFF: TINA NOYES ORIGINALLY, AND THEN I THINK SIGNED BY DR. GELB AND THEN REVISED SOME YEARS LATER.

778

MR. WADE: SOME YEARS LATER BY DR. MASINDE. DO YOU RECALL THAT?

780

MR. WADE: AND SIGNED BY MR. LANGLY GEE?

782

MR. WADE: AND BY HODA ALAMDAR?

784

MR. WADE: AND LINA CASTRO?

786

MR. WADE: AND YOU?

788

MR. WADE: ALL RIGHT. LET ME SHOW YOU EXHIBIT 1430, WHICH SHOULD BE CHRONOLOGICALLY IN YOUR BINDER. FOR THE COURT, IT WAS IN THE RED WELD THAT WAS HANDED UP.

789

ADAM ROSENDORFF: THE YELLOW BINDER?

790

MR. WADE: NO, NO. THE BLACK -- I THINK IT'S BLACK, VOLUME 1. THE EXHIBITS, VOLUME 1.

791

ADAM ROSENDORFF: IT'S PATENTS. I DO NOT HAVE 1401.

792

MR. WADE: 1430. THERE'S A LOT OF NUMBERS FLYING AROUND HERE. DO YOU HAVE A 1430?

794

MR. WADE: AND DO YOU RECOGNIZE THAT AS AN EMAIL FROM YOU TO THE CLIA LAB GROUP?

796

MR. WADE: JANUARY 16TH, 2014?

798

MR. WADE: I WOULD MOVE THE ADMISSION OF 1430, YOUR HONOR.

799

MR. BOSTIC: NO OBJECTION.

800

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

801

(GOVERNMENT'S EXHIBIT 1430 WAS RECEIVED IN EVIDENCE.)

802

BY MR. WADE:

803

MR. WADE: THIS IS AN EMAIL THAT YOU SENT ON JANUARY 16TH, 2014, TO THE CLIA LAB GROUP. DO YOU SEE THAT?

805

MR. WADE: AND YOU NOTED IT WAS A HIGH PRIORITY; RIGHT?

807

MR. WADE: YOU THOUGHT THIS WAS IMPORTANT?

809

MR. WADE: OKAY. AND THIS IS THE -- THIS INCLUDES AN ATTACHMENT OF A QUALITY CONTROL POLICY; RIGHT?

811

MR. WADE: AND I TAKE IT, GIVEN THAT YOU WERE COMMUNICATING THIS OUT AS A HIGH IMPORTANCE TO THE CLIA TEAM, YOU -- WAS THIS YOUR INSTRUCTION TO THE CLIA TEAM THAT YOU WANTED THIS FOLLOWED?

813

MR. WADE: OKAY. AND I TAKE IT THEN IT WAS YOUR EXPECTATION IT WOULD BE FOLLOWED; RIGHT?

815

MR. WADE: OKAY. LET'S GO TO THE ATTACHMENT. AND THIS ONE ISN'T SIGNED YET BECAUSE IT LOOKS LIKE MAYBE YOU HAD JUST CREATED IT; RIGHT?

817

MR. WADE: AND, IN FACT, THE EMAIL IS -- ACTUALLY, LET ME JUST BACK UP QUICKLY TO THE EMAIL. SOMETIMES THE TOP EMAILS IN THESE CHAINS WE HAVE LEARNED ARE IN GREENWICH MEANTIME OR UTC?

819

MR. WADE: I TAKE IT YOU WERE NOT WORKING AT 2:00 A.M. PROBABLY ON A QC POLICY, WERE YOU?

820

ADAM ROSENDORFF: IT'S POSSIBLE.

821

MR. WADE: OKAY. YOU WERE WORKING HARD?

822

ADAM ROSENDORFF: YES, I WAS.

823

MR. WADE: OFTENTIMES THESE ARE SIX OR SEVEN HOURS EARLIER, IF THAT SEEMS RIGHT, AND IF SO, THAT WOULD PLACE THE TRANSMITTAL OF THE EMAIL AS JANUARY 15TH, DO YOU SEE, BECAUSE IT WOULD BRING IT IN THE PRIOR DAY?

825

MR. WADE: AND IF YOU TURN TO THE, IF THE TURN TO THE SOP, I THINK YOU SEE THE EFFECTIVE DATE IS JANUARY 15TH, 2014. DO YOU SEE THAT?

827

MR. WADE: AND SO IT LOOKS LIKE THIS HAD JUST BEEN FINALIZED AND TRANSMITTED OUT TO THE GROUP; RIGHT?

829

MR. WADE: AND THESE WERE THE PROCEDURES THAT YOU WANTED THEM TO FOLLOW?

831

MR. WADE: AND THAT'S ON -- IF WE GO TO THE NEXT PAGE, THIS INCLUDES UP AT THE TOP THE DAILY QC?

833

MR. WADE: DO YOU SEE THAT?

835

MR. WADE: AND IT JUST SETS FORTH THE POLICY THAT YOU WANTED FOLLOWED?

837

MR. WADE: AND IF YOU GO DOWN TO THE BOTTOM. AND IF WE CAN BLOW THAT UP. THAT'S THE CONTINUOUS QC; RIGHT?

838

ADAM ROSENDORFF: THESE ARE THE WESTGARD RULES.

839

MR. WADE: THIS IS WHAT WE WERE TALKING ABOUT BEFORE; RIGHT?

841

MR. WADE: OKAY. SO THIS IS WHERE YOU LOOKED AT THOSE LEVEY-JENNINGS CHARTS OF QUALITY CONTROL DATA; RIGHT?

843

MR. WADE: AND YOU LOOK AT IT OVER A LONG PERIOD OF TIME?

845

MR. WADE: AND YOU ASSESS SOME RULES AS TO WHETHER OR NOT THE ASSAY IS COMPLIANT?

846

ADAM ROSENDORFF: WHETHER THE QC IS PASSING.

847

MR. WADE: RIGHT.

849

MR. WADE: BECAUSE THERE COULD BE CIRCUMSTANCES WHERE QC PASSES ON A DAILY BASIS UNDER THE DAILY RULE; RIGHT?

851

MR. WADE: BUT IF YOU LOOK AT ITS PERFORMANCE CONSISTENTLY OVER TIME, THAT THE CONSISTENT TREND OVER TIME WOULD SUGGEST AN ISSUE THAT SHOULD BE ADDRESSED; RIGHT?

852

ADAM ROSENDORFF: YES, YOU ARE RIGHT.

853

MR. WADE: AND THAT'S WHAT THE CONTINUOUS QC IS FOR; RIGHT?

855

MR. WADE: AND THAT'S WHY YOU WANTED THE FOLKS WITHIN THE COMPANY TO FOLLOW THAT CONTINUOUS QUALITY CONTROL?

857

MR. WADE: AND IF THERE WAS AN ISSUE WITH EITHER THE DAILY CONTROL OR THE CONTINUOUS CONTROL, YOU WERE TO CEASE USING THE ASSAY, CORRECT, UNTIL THAT ISSUE WAS ADDRESSED?

858

ADAM ROSENDORFF: YOU COULDN'T RUN THAT ASSAY FOR THAT INSTRUMENT UNTIL THAT ISSUE WAS ADDRESSED.

859

MR. WADE: RIGHT. UNTIL YOU WERE BACK IN COMPLIANCE WITH THE POLICY; RIGHT?

861

MR. WADE: AND IF WE GO TO THE NEXT PAGE, THIS SETS FORTH A VERY SPECIFIC POLICY WITH RESPECT TO THE EDISON QC; RIGHT?

863

MR. WADE: AND YOU IDENTIFY THAT SPECIFICALLY AND SEPARATELY WITHIN THIS DOCUMENT?

865

MR. WADE: CORRECT?

867

MR. WADE: OKAY. AND YOU EXPECTED THAT THAT WOULD BE FOLLOWED?

868

ADAM ROSENDORFF: YES, I EXPECTED IT TO BE FOLLOWED.

869

MR. WADE: AND IT WAS CLEAR PROCESS; RIGHT?

871

MR. WADE: OKAY. AND I JUST WANT TO BE VERY, VERY CLEAR, BECAUSE I KNOW THIS IS OLD HAT TO YOU, BUT FOR SOME OF US IT IS NOT, QC SAMPLES ARE NOT PATIENT SAMPLES; RIGHT?

873

MR. WADE: SO IF A QC TEST IS RUN AND IT FAILS, THAT DOESN'T MEAN SOMETHING BAD HAPPENED TO A PATIENT; RIGHT? THAT DOESN'T MEAN THAT THAT PATIENT'S BLOOD TEST WAS SCREWED UP?

874

ADAM ROSENDORFF: NO, NO. YOU RUN THE QC BEFORE YOU RUN THE PATIENT SAMPLES.

875

MR. WADE: RIGHT. AND YOU ONLY RUN A PATIENT SAMPLE IF THE INSTRUMENT PASSES QUALITY CONTROL?

877

MR. WADE: OKAY. AND ON A DAY-TO-DAY BASIS IT WAS LANGLY GEE WHO WAS RESPONSIBLE FOR THE DAY-TO-DAY QUALITY MANAGEMENT; RIGHT?

879

MR. WADE: AND MR. GEE, WAS HE SOMEONE YOU HIRED, OR DID YOU INHERIT HIM WITHIN THE LAB?

880

ADAM ROSENDORFF: WE HIRED HIM.

881

MR. WADE: LET'S LOOK AT EXHIBIT 10281, WHICH SHOULD BE IN THE BACK OF VOLUME 1 OF YOUR BLACK EXHIBITS BINDER. AND, AGAIN, IT'S 10281.

882

ADAM ROSENDORFF: I'VE GOT IT.

883

MR. WADE: AND DO YOU RECOGNIZE THAT TO BE THE RESUME OF MR. GEE?

885

MR. WADE: AND MOVE THE ADMISSION OF EXHIBIT 10281, ALTHOUGH I WOULD ASK THAT ANY IDENTIFICATION INFORMATION BE REDACTED FROM IT BEFORE WE PUBLISH.

886

MR. BOSTIC: NO OBJECTION, YOUR HONOR.

887

JUDGE DAVILA: IT'S ADMITTED, BUT THE PERSONAL INFORMATION AT THE TOP WILL BE REDACTED.

888

(DEFENDANT'S EXHIBIT 10281 WAS RECEIVED IN EVIDENCE.)

889

BY MR. WADE:

890

MR. WADE: AND YOU RECOGNIZE THIS TO BE MR. GEE'S CURRICULUM VITAE?

891

ADAM ROSENDORFF: DO I RECOGNIZE IT NOW?

892

MR. WADE: YOU RECOGNIZE THAT THIS WAS HIS RESUME; RIGHT?

893

ADAM ROSENDORFF: YEAH, IT APPEARS TO BE HIS RESUME.

894

MR. WADE: AND YOU HIRED HIM?

896

MR. WADE: AND ONE OF THE REASONS --

897

ADAM ROSENDORFF: I WANT TO CLARIFY. I INTERVIEWED HIM. I DID NOT MAKE THE HIRING DECISIONS FOR THE LABORATORY AT THERANOS.

898

MR. WADE: AND DID MR. BALWANI MAKE THOSE DECISIONS?

899

ADAM ROSENDORFF: AND MS. HOLMES, YES.

901

ADAM ROSENDORFF: NOBODY WOULD BE HIRED UNLESS THEY APPROVED IT, AND IN MOST INSTANCES THEY WOULD ACTUALLY INTERVIEW THOSE INDIVIDUALS, YEAH.

902

MR. WADE: AND, IN FACT, MS. HOLMES INTERVIEWED ALMOST EVERY INDIVIDUAL THAT WAS HIRED; ISN'T THAT RIGHT?

903

ADAM ROSENDORFF: I BELIEVE SO.

904

MR. WADE: OKAY. AND IN THAT PROCESS, IF YOU RECALL, SIR, THE PEOPLE WHO HAD SORT OF DAY-TO-DAY RESPONSIBILITY WOULD TYPICALLY INTERVIEW THE PERSON FIRST; RIGHT? DO YOU RECALL THAT?

905

ADAM ROSENDORFF: IT WAS USUALLY ME.

907

ADAM ROSENDORFF: AND THEN IF I GAVE A THUMBS UP, IT WOULD GO TO SUNNY AND ELIZABETH, YEAH.

908

MR. WADE: AND DO YOU RECALL SOMETIMES WHEN DR. PANDORI WAS AROUND HE WOULD DO THOSE INTERVIEWS WITH YOU, TOO?

910

MR. WADE: AND LIKE YOU SAID, YOU GIVE THEM A THUMBS UP OR A THUMBS DOWN AND MAKE THAT RECOMMENDATION AND PASS IT ON TO SUNNY AND ELIZABETH?

912

MR. WADE: AND THEN THEY WOULD INTERVIEW THEM WITH THE BENEFIT OF YOUR RECOMMENDATION?

914

MR. WADE: OKAY. AND SO I TAKE IT YOU RECOMMENDED TO HIRE MR. GEE?

916

MR. WADE: AND THEY AGREED WITH YOUR RECOMMENDATION IN THIS CASE?

918

MR. WADE: AND WAS PART OF THE REASON THAT YOU HIRED MR. GEE WAS BECAUSE HE WAS AN EXPERIENCED QUALITY SYSTEMS MANAGER?

920

MR. WADE: AND HE HAD ACTUALLY DONE WORK AND MAINTAINED A QUALITY SYSTEMS PROGRAM UNDER CLIA AND NEW YORK REGULATIONS PREVIOUSLY; RIGHT?

922

MR. WADE: AND HE HAD ACTUALLY HELD POSITIONS OF THAT NATURE AT A COUPLE OF DIFFERENT COMPANIES; RIGHT?

923

ADAM ROSENDORFF: IT APPEARS FROM HIS RESUME AND READING IT NOW THAT HIS EXPERIENCE IN QUALITY MANAGEMENT WAS AT TETHYS BIOSCIENCES FROM 2012. PREVIOUSLY HE WAS AT BIO-RAD WHERE HE WAS INVOLVED IN REAGENTS AND QUALITY CONTROL.

924

MR. WADE: OKAY. AND WE'VE HEARD A LOT OF TALK ABOUT REAGENTS IN THIS CASE. THAT'S SOMETHING THAT IS ROUTINELY USED WITHIN THE LABORATORY; CORRECT?

926

MR. WADE: AND HE DID SOME WORK, QUALITY WORK IN CONNECTION WITH THAT?

928

MR. WADE: AND THEN HE DID THE CLIA AND NEW YORK REGULATORY WORK IN CONNECTION WITH HIS TIME AT TETHYS BIOSCIENCE?

930

MR. WADE: AND YOU THOUGHT HE WAS WELL QUALIFIED FOR THAT POSITION?

932

MR. WADE: NOW, YOU TESTIFIED ON DIRECT EXAMINATION ABOUT SOME QUALITY -- SOME CONCERNS THAT YOU HAD ABOUT QUALITY CONTROL. DO YOU RECALL THAT?

934

MR. WADE: OKAY. AND ULTIMATELY IT'S YOUR JOB TO HAVE THOSE CONCERNS; RIGHT?

936

MR. WADE: AND THAT'S WHY YOU'RE, YOU'RE PAID THE BIG BUCKS; RIGHT?

937

ADAM ROSENDORFF: NOT AS BIG BUCKS AS YOU GET PAID.

938

(LAUGHTER.)

939

BY MR. WADE:

940

MR. WADE: WELL, LET'S FOCUS ON THE RELEVANT EVIDENCE, AND I HATE TO ASK SUCH A PERSONAL QUESTION --

942

MR. WADE: -- BUT IT IS SOMEWHAT RELEVANT TO THE CASE JUST GIVEN SOME OF THE ISSUES. DO YOU RECALL HOW MUCH YOU WERE COMPENSATED FOR YOUR WORK AT THERANOS?

943

ADAM ROSENDORFF: IT'S IN MY OFFER LETTER. I BELIEVE IT WAS $220,000 PER YEAR.

944

MR. WADE: DO YOU RECALL MAYBE IT WAS $240,000 PER YEAR?

945

ADAM ROSENDORFF: IT MAY HAVE BEEN.

946

MR. WADE: IT WAS A SUBSTANTIAL RAISE OVER WHAT YOU HAD BEEN PAID OVER AT UPMC?

948

MR. WADE: AND DID YOU CONSIDER THAT TO BE GENEROUS COMPENSATION?

949

ADAM ROSENDORFF: IT WAS IN LINE WITH, WITH SIMILAR POSITIONS AT SIMILAR COMPANIES IN THE BAY AREA.

950

MR. WADE: OKAY. AND DO YOU KNOW THAT YOU WERE ONE OF THE HIGHEST COMPENSATED PEOPLE IN THE COMPANY? WERE YOU AWARE OF THAT?

952

MR. WADE: OKAY. AND SO, AGAIN, IT'S YOUR, YOUR -- WE'VE TALKED ABOUT THE IMPORTANCE OF YOUR JOB AND ALL OF THE RESPONSIBILITIES THAT YOU HOLD, AND YOU FELT LIKE YOU WERE COMPENSATED FAIRLY FOR THAT?

954

MR. WADE: OKAY. AND --

955

ADAM ROSENDORFF: IN RETROSPECT, GIVEN THE QUALITY ISSUES AND THE RISKS, PROFESSIONAL RISKS AND PROBLEMS AT THERANOS, I THINK THAT I SHOULD HAVE BEEN PAID MUCH, MUCH MORE. AND IN VIEW OF THE LEGAL EXPENSES THAT I'VE HAD TO GO THROUGH IN THE LAST SEVEN OR EIGHT YEARS.

956

MR. WADE: I WOULD MOVE TO STRIKE, YOUR HONOR.

957

JUDGE DAVILA: THE LAST PORTION WILL BE STRICKEN AS NONRESPONSIVE.

958

BY MR. WADE:

959

MR. WADE: NOW, MANY OF THE CONCERNS THAT THE GOVERNMENT DISCUSSED WITH YOU WERE CONCERNS THAT HAD HAPPENED IN THE FIRST HALF OF 2014. DO YOU RECALL THAT? IF YOU'RE UNCERTAIN, I CAN HELP REFRESH YOUR RECOLLECTION A BIT.

961

MR. WADE: DO YOU RECALL THERE WERE SOME EMAILS IN MARCH OF 2014 ABOUT QUALITY CONTROL?

963

MR. WADE: DO YOU RECALL THAT?

965

MR. WADE: WITHIN ONE OF THE EMAILS THERE WERE SOME, THERE WERE SOME STATS THAT WERE SHOWN TO YOU ABOUT THE QUALITY CONTROL PERFORMANCE?

967

MR. WADE: OKAY. AND, AGAIN, QUALITY CONTROL WAS SOMETHING THAT YOU WERE ATTENTIVE TO IN YOUR JOB?

969

MR. WADE: OKAY. AND WHEN YOU WERE LOOKING AT THOSE ISSUES, YOU WEREN'T ALWAYS SURE WHAT THE ROOT CAUSE OF THE ISSUE WAS; RIGHT?

970

ADAM ROSENDORFF: I NARROWED -- NO, I COULDN'T NOT -- I DIDN'T HAVE DATA TO PINPOINT THE ROOT CAUSE.

971

MR. WADE: RIGHT. IT WASN'T CLEAR WHAT IT WAS?

972

ADAM ROSENDORFF: ALL THAT I KNEW WAS THAT THE INSTRUMENT WAS NOT PERFORMING ANYWHERE CLOSE TO THE PERFORMANCE THAT WE SAW IN THE VALIDATION STUDIES.

973

MR. WADE: UNDERSTOOD. AND SO WHAT YOU WERE DOING WHEN YOU WERE DOING QUALITY CONTROL WAS TESTING THE PERFORMANCE AND QUALITY CONTROL BACK TO THE VALIDATION STUDY; RIGHT?

975

MR. WADE: OKAY. I DIDN'T SEE THAT REFERENCED SPECIFICALLY IN THAT POLICY, BUT MAYBE AS A LAB DIRECTOR THAT WOULD BE SOMETHING THAT YOU WOULD LOOK AT?

977

MR. WADE: OKAY. AS PART OF YOUR OVERALL COMPLIANCE RESPONSIBILITIES?

979

MR. WADE: THAT'S A PRETTY SOPHISTICATED ANALYSIS, ISN'T IT?

980

ADAM ROSENDORFF: WELL, I, I WAS OBLIGED TO MAKE AN ASSESSMENT OF WHETHER THE INSTRUMENTS WERE PERFORMING ACCORDING TO THE PASSING CRITERIA AND SPECIFICATIONS THAT WERE DEMONSTRATED IN THE VALIDATION REPORT. IF THAT WAS NOT THE CASE, THEN THAT WOULD POINT TO A SERIOUS PROBLEM.

981

MR. WADE: RIGHT. AND IF IT POINTED TO A SERIOUS PROBLEM OF A SUFFICIENT NATURE, YOU WOULD PULL THE ASSAY, WOULDN'T YOU?

983

MR. WADE: YES. THAT WAS YOUR OBLIGATION TO PULL THAT ASSAY IF IT RAISED TO A CERTAIN LEVEL THAT YOU DIDN'T THINK IT COULD PROVIDE SAFE AND RELIABLE RESULTS TO PATIENTS; RIGHT?

985

MR. WADE: AND YOU DID THAT SOMETIMES ON A --

986

ADAM ROSENDORFF: IN CERTAIN INSTANCES, YES.

987

MR. WADE: AND THAT WAS SOMETHING THAT YOU WERE MONITORING REGULARLY?

989

MR. WADE: AND YOU HAD THE SOPHISTICATION AND EXPERIENCE TO DO THAT?

991

MR. WADE: AND YOU HAD ACCESS TO ALL OF THE DATA TO DO THAT; RIGHT?

993

MR. WADE: AND IF IT WASN'T IN FRONT OF YOU IN AN EMAIL, YOU COULD GO AND ASK MR. GEE OR ONE OF THE OTHER PEOPLE WHO WORKED FOR YOU TO PULL WHATEVER INFORMATION YOU NEEDED TO DO THAT ANALYSIS; RIGHT?

995

MR. WADE: AND AT TIMES YOU DID; RIGHT?

997

MR. WADE: YEAH. AND THERE WERE TIMES WHERE YOU THOUGHT MAYBE SOME OF THE ISSUES RELATED TO REAGENTS; RIGHT?

999

MR. WADE: AND WHETHER THERE WERE CONCERNS ABOUT EITHER THE QUALITY AGE OR SOME PERFORMANCE CHARACTERISTIC OF THE REAGENT; RIGHT?

1001

MR. WADE: AND IN THOSE CASES, SOMETIMES WOULD THE PEOPLE WITHIN THE LAB REPLACE THE REAGENTS AND SEE IF OTHER REAGENTS PERFORMED DIFFERENTLY?

1002

ADAM ROSENDORFF: YES. I BELIEVE THERE'S SOME EMAILS FROM ERIKA CHEUNG TO THE EFFECT THAT SHE REPLACED THE MANUALLY FILLED CARTRIDGES WITH CAPSYS CARTRIDGES TO SEE IF THAT IMPROVED THE QC PERFORMANCE.

1003

MR. WADE: OKAY. I JUST HEARD SOMETHING HAPPEN WITH THE MIKE. IS EVERYTHING OKAY? I WOULD JUST INQUIRE OF THE COURT. OKAY. IS IT OKAY? SHOULD WE TAKE JUST A MINUTE, YOUR HONOR?

1004

COURT CLERK: LET ME JUST RESET THE SYSTEM. HOLD ON.

1005

JUDGE DAVILA: THANK YOU.

1006

COURT CLERK: IT WILL JUST TAKE A MOMENT. LET'S TRY IT AGAIN.

1007

(PAUSE IN PROCEEDINGS.)

1008

BY MR. WADE:

1009

MR. WADE: OKAY. AND YOU CAN HEAR ME OKAY, SIR?

1011

MR. WADE: OKAY. I THINK WE SOLVED IT THERE. LET ME JUST STEP BACK BROADLY AND TALK ABOUT POTENTIAL SOURCES OF ERROR WITHIN THE LAB. OKAY?

1013

MR. WADE: AND THERE ARE -- DO YOU RECALL THAT THERE ARE SOME BUCKETS THAT ARE PREANALYTIC, ANALYTIC, AND POST-ANALYTIC ERRORS?

1015

MR. WADE: AND PREANALYTIC ERRORS ARE ESSENTIALLY MISTAKES OR PROBLEMS THAT HAPPEN BEFORE THE TEST IS ACTUALLY ENTERED INTO A MACHINE; RIGHT?

1017

MR. WADE: AND THEN AN ANALYTIC ERROR IS THE ERROR THAT HAPPENS WHEN THE TEST IS RUNNING WITHIN THE MACHINE?

1018

ADAM ROSENDORFF: ANALYTIC APPLIES TO THE STEPS THAT ARE CONDUCTED WITHIN THE LABORATORY AND IT COULD INCLUDE PREPROCESSING OR PREPARATION OF THE SAMPLES BEFORE THEY GO INTO A MACHINE.

1019

MR. WADE: OKAY. AND THEN POST-ANALYTIC IS WHAT HAPPENS AFTERWARDS; RIGHT?

1021

MR. WADE: OKAY. AND CAN YOU JUST IDENTIFY FOR THE BENEFIT OF THE JURY, GIVE US A SENSE OF, YOU KNOW, WHAT ARE THE PREANALYTIC ERRORS THAT CAN HAPPEN WITHIN A LAB?

1022

ADAM ROSENDORFF: I CAN TELL YOU ABOUT THE ERRORS THAT HAPPENED AT THERANOS.

1023

MR. WADE: I'M JUST WONDERING AND ASKING GENERALLY SO WE CAN GET A SENSE OF THE RANGE OF THE PREANALYTIC ERRORS, OKAY?

1024

ADAM ROSENDORFF: PROBLEMS WITH SPECIMEN COLLECTION AND THE INTEGRITY OF THE SAMPLE BEFORE IT ARRIVES IN THE LAB, SUCH AS HEMOLYSIS; INTERFERING SUBSTANCES THAT WAS REFERRED TO AS A SPECIFICITY IN THE LAST EMAIL; LIPEMIA IN A SAMPLE; IMPROPER TEMPERATURE EXCURSIONS DURING TRANSPORTATION; SHAKING OF THE SAMPLE; VIBRATION; DAMAGE TO THE SAMPLE; ET CETERA.

1025

MR. WADE: AND IF YOU HAVE A LONG LIST, YOU CAN PROBABLY COME UP WITH FIVE OR TEN MORE DO YOU THINK?

1027

MR. WADE: IT'S BASICALLY IN THAT EARLY PROCESS?

1028

ADAM ROSENDORFF: IT COULD BE A SPECIMEN MIXUP, SO SWITCHING -- IDENTIFIERS BEING SWITCHED.

1029

MR. WADE: AND IT COULD BE A HUMAN ERROR RELATING TO DOCUMENTING SOMETHING WITH RESPECT TO THE LAB ORDER; RIGHT?

1031

MR. WADE: IT COULD BE HOW IT'S ENTERED INTO A COMPUTER?

1033

MR. WADE: ANYTHING? THERE'S A WHOLE HOST OF ISSUES WITHIN THAT PREANALYTIC BUCKET; RIGHT?

1035

MR. WADE: AND SOMETIMES IT'S HARD TO FIGURE OUT WHAT THE ERROR MIGHT BE; RIGHT?

1037

MR. WADE: AND THAT'S WHY IF THERE'S A PROBLEM THAT COMES UP, YOU'LL TRY TO GET ALL OF THE DATA THAT YOU CAN RELATING TO A PARTICULAR PATIENT FROM THE LIS SO THAT YOU HAVE THE FULL PICTURE; RIGHT?

1039

MR. WADE: OKAY. AND THEN WHAT IS THE ANALYTIC CATEGORY OF ERRORS? CAN YOU GIVE US A SENSE OF GENERALLY WITHIN THE LAB, WHAT ARE THE AREAS IN WHICH THERE COULD BE ANALYTIC ERRORS?

1040

ADAM ROSENDORFF: A FLAW IN THE INSTRUMENTATION, IN THE DESIGN OR PERFORMANCE OF THE INSTRUMENTATION; A FAULT IN THE REAGENT, A FLAW IN THE REAGENT ITSELF; POTENTIALLY CONTAMINATION OF THE SAMPLE WITHIN THE LABORATORY, PARTICULARLY FOR MOLECULAR TESTS; CROSS-CONTAMINATION OF ONE SAMPLE TO ANOTHER; SPILLOVER; A TEST -- A LAB TECH NOT FOLLOWING THE OPERATING PROCEDURE AND ADDING THE WRONG REAGENTS; INSTRUMENT ERRORS; SOFTWARE ERRORS; PIPETTING ERRORS; SKIPPED WELLS; IMPROPER CENTRIFUGATION. THE LIST GOES ON AND ON.

1041

MR. WADE: THE TEMPERATURE OF THE LAB COULD BE BAD?

1042

ADAM ROSENDORFF: CORRECT. THE TEMPERATURE AND HUMIDITY HAS TO BE MONITORED.

1043

MR. WADE: THE POWER COULD GO OUT? THERE ARE ALL SORTS OF ISSUES WITHIN THAT PHASE WHERE SOMETHING COULD GO WRONG; RIGHT?

1045

MR. WADE: AND IN THE POST-ANALYTIC PHASE, WHAT ARE THE ERRORS THAT CAN HAPPEN IN THE POST-ANALYTIC PHASE?

1046

ADAM ROSENDORFF: AN ERROR IN THE DATA TRANSMISSION BETWEEN THE LABORATORY RESULTS AND THE ACTUAL REPORT NOT MATCHING UP. AGAIN, YOU CAN HAVE PATIENT IDENTIFIERS BEING SWAPPED OR SOME KIND OF CLERICAL ERROR WHEN THE CLS ENTERS THE DATA INTO THE SYSTEM AND IT DOESN'T COME OUT RIGHT IN THE REPORT; SOFTWARE GLITCHES THAT PREVENT THE REPORT GETTING TO THE INFORMATION; THE WRONG REFERENCE RANGE BEING APPLIED TO A TEST.

1047

MR. WADE: AND THESE ARE COMPUTERIZED; RIGHT?

1049

MR. WADE: AND SO THERE COULD BE SOME COATING ERROR OR SOME SOFTWARE MALFUNCTION?

1051

MR. WADE: AND IT COULD BE AS SIMPLE AS SOME SORT OF TRANSCRIPTION ERROR; RIGHT?

1053

MR. WADE: AND WE HAVE SEEN SOME OF MY ERRORS WITH RESPECT TO SOME OF THE NUMBERS IN THIS CASE, HAVEN'T WE?

1055

MR. WADE: AND THOSE SECOND TWO CATEGORIES, THOSE ARE CATEGORIES THAT SIMILARLY SOMETIMES YOU WOULD GO AND YOU WOULD GET WHATEVER YOU COULD OUT OF THE LAB INFORMATION SYSTEM IN ORDER TO ASSESS THE PROBLEM; CORRECT?

1057

MR. WADE: AND WHEN YOU'RE DOING -- BACK TO THE QC FUNCTION. WHEN THE QC FUNCTION IS BEING PERFORMED BY MR. GEE AND HE'S CREATING DATA THAT IS PRESENTED TO YOU, FOR THE MOST PART YOU'RE LOOKING AT THAT IN THE FIRST INSTANCE ON AN ASSAY-BY-ASSAY BASIS; RIGHT?

1059

MR. WADE: AND WE'VE TALKED ABOUT THE WIDE RANGE OF DIFFERENT INSTRUMENTS THAT WERE RUNNING WITHIN THE THERANOS LAB; RIGHT?

1061

MR. WADE: AND YOU WOULD LOOK AT QC ON EACH AND EVERY ONE OF THOSE MACHINES; RIGHT?

1063

MR. WADE: AND IT'S A BIG JOB?

1065

MR. WADE: A LOT OF RESPONSIBILITY FOR MR. GEE; CORRECT?

1066

ADAM ROSENDORFF: WELL, IT'S A RESPONSIBILITY OF THE CLS'S AND LAB TECHS TO MAKE SURE THE QC PASSES FOR EACH RUN. DR. GEE DOESN'T HAVE TO LOOK AT THAT ON A --

1067

MR. WADE: RIGHT. MR. GEE CAN'T GO TO EACH AND EVERY MACHINE AND PERFORM THOSE DAILY QC TESTS; RIGHT?

1069

MR. WADE: AND IT'S A TEAM EFFORT TO GET THAT DATA AND TO FEED IT TO MR. GEE; RIGHT?

1071

MR. WADE: AND HE THEN DOES AN ANALYSIS OF IT; RIGHT?

1073

MR. WADE: AND THEN YOU DO AN ANALYSIS OF IT?

1075

MR. WADE: AND IN LOOKING AT THOSE CONCERNS THAT YOU DISCUSSED WITH THE GOVERNMENT ON DIRECT, YOU NEVER INSTRUCTED THE CLIA TEAM AT ANY POINT TO JUST STOP USING THE EDISON DEVICE ALTOGETHER, DID YOU?

1076

ADAM ROSENDORFF: I DID NOT. I DID FOR HCG, AND THERE MAY HAVE BEEN ANOTHER TEST THAT WE WERE DISCUSSING WHERE I SAID PLEASE DISCONTINUE ON THE EDISON.

1077

MR. WADE: RIGHT. AND SPECIFICALLY I THINK I SEE THAT AS THE RESULT OF SOME OF YOUR WORK WITHIN THE LAB, YOU IDENTIFIED ISSUES WHERE YOU HALTED ANY REPORTING OF RESULTS; RIGHT?

1079

MR. WADE: AND THAT WAS CONSISTENT WITH YOUR REGULATORY RESPONSIBILITY TO MAKE SURE THAT PATIENTS GOT ACCURATE AND RELIABLE RESULTS; RIGHT?

1081

MR. WADE: BUT YOU NEVER HALTED THE USE OF THE EDISON SYSTEM ALTOGETHER; CORRECT?

1083

MR. WADE: IN FACT, THROUGHOUT YOUR TIME AT THERANOS, THE COMPANY CONTINUED TO VALIDATE TESTS THROUGHOUT THE TIME PERIOD; CORRECT?

1085

MR. WADE: OKAY. I HAVE IN FRONT OF YOU A BINDER OF ASSAY VALIDATION REPORTS. DO YOU SEE THAT BINDER? IT'S A SEPARATE BINDER OF JUST ASSAY VALIDATION REPORTS.

1086

ADAM ROSENDORFF: YES, I HAVE IT.

1087

MR. WADE: AND I WILL REPRESENT TWO THINGS TO YOU, ONE OF WHICH MAY -- HOPEFULLY BOTH OF WHICH ARE COMFORTING. THESE ARE ALL DOCUMENTS AND VALIDATION REPORTS THAT YOU SIGNED WHILE YOU WERE A LAB DIRECTOR.

1089

MR. WADE: AND I'M NOT GOING TO GO THROUGH ALL OF THEM. OKAY? BUT I DO WANT TO GO THROUGH A COUPLE. AND BY STIPULATION WITH THE GOVERNMENT, YOUR HONOR, WE HAVE MOVED THE ADMISSION OF ALL OF THESE VIA WRITTEN DOCUMENT, WHICH I'VE TENDERED TO THE COURT REPORTER JUST SO WE DON'T HAVE TO READ THROUGH ALL OF THE NUMBERS HERE ON THE RECORD IF THAT'S -- IF IT'S OKAY WITH THE COURT TO PROCEED IN THAT MANNER.

1090

COURT CLERK: DO YOU HAVE AN EXTRA COPY, COUNSEL?

1091

MR. WADE: (HANDING.)

1092

JUDGE DAVILA: ALL RIGHT. THANK YOU. AND YOU'RE GOING TO COVER THESE IN YOUR EXAMINATION?

1093

MR. WADE: I'M GOING TO COVER CERTAIN OF THEM IN THE EXAMINATION, AND I'LL IDENTIFY THE NUMBERS. THE OTHERS WE WOULD LIKE IN EVIDENCE BECAUSE WE MAY USE THEM FOR OTHER PURPOSES AND DR. ROSENDORFF SIGNED ALL OF THEM.

1094

JUDGE DAVILA: AND THE -- I'M JUST TRYING TO DISCERN WHETHER I NEED TO READ ALL OF THESE NUMBERS TO THE JURY NOW. ARE YOU GOING TO TALK ABOUT ALL OF THESE?

1095

MR. WADE: AS I GO THROUGH THEM, I CAN IDENTIFY THEM AS A DOCUMENT THAT IS IN ADMISSION BY STIPULATION IF THAT'S OKAY.

1096

JUDGE DAVILA: WHY DON'T YOU DO THAT. LADIES AND GENTLEMEN, YOU'RE GOING TO HEAR TESTIMONY ABOUT SOME EXHIBITS. I DO HAVE A DOCUMENT FROM COUNSEL INDICATING THAT THEY HAVE STIPULATED, THEY HAVE STIPULATED TO THE ADMISSION OF THESE EXHIBITS. PLEASE RECALL IN MY PRELIMINARY INSTRUCTIONS I TOLD YOU WHEN THE PARTIES STIPULATE TO SOMETHING, THAT MEANS THAT THEY HAVE REACHED AGREEMENT THAT IT MAY BE INTRODUCED INTO EVIDENCE AND THAT YOU MAY CONSIDER THAT IN YOUR DELIBERATIONS. THERE ARE PERHAPS 30, 40 NUMBERS HERE. I'M NOT GOING TO READ THEM ALL TO YOU NOW, BUT COUNSEL HAVE INDICATED THAT THIS PART OF THE EXAMINATION WILL TOUCH ON THESE. YOU'LL HAVE THE STIPULATION AND IT WILL BE PART OF THE EVIDENCE TO REFER TO SHOULD YOU WISH TO IDENTIFY A SPECIFIC DOCUMENT. AS YOU GO THROUGH, COUNSEL, JUST IDENTIFY, PLEASE, THE DOCUMENTS THAT ARE GOING TO BE ADMITTED PURSUANT TO THE STIPULATION. I THINK THAT WOULD CLEAR THE RECORD. THANK YOU.

1097

MR. WADE: GREAT. THANK YOU, YOUR HONOR. AND THANK YOU TO THE GOVERNMENT FOR THE STIPULATION.

1098

MR. WADE: I'D LIKE TO FIRST DRAW YOUR ATTENTION TO EXHIBIT 9368, WHICH IS AMONG THE STIPULATED EXHIBITS. IT'S TOWARDS THE BACK. THEY SHOULD BE NUMERICAL IN ORDER.

1100

MR. WADE: OKAY. AND THIS IS THE VALIDATION REPORT THAT WE'VE BEEN TALKING ABOUT SO MUCH HERE; RIGHT?

1101

ADAM ROSENDORFF: I'M NOT SURE WHAT YOU MEAN.

1102

MR. WADE: OKAY. YOU RECALL THAT YOU TESTIFIED ABOUT VALIDATION REPORTS FOR THE CLIA LAB PREVIOUSLY?

1104

MR. WADE: AND THIS IS AN EXAMPLE OF ONE; RIGHT?

1106

MR. WADE: AND THIS IS FOR THE TSH ELISA ASSAY. DO YOU SEE THAT?

1108

MR. WADE: AND IT'S ON THE EDISON -- IT'S ON THE EDISON THERANOS SYSTEM; RIGHT?

1110

MR. WADE: AND THAT'S -- AND THIS IS ONE OF THE EARLIER EDISON ASSAYS; CORRECT?

1112

MR. WADE: AND DO YOU SEE YOUR SIGNATURE THERE? THE DATE IS 9-30-2013?

1114

MR. WADE: AND SO THIS WOULD HAVE BEEN VALIDATED FOR THE PURPOSES OF THE CLIA LABORATORY AS OF THAT DATE?

1116

MR. WADE: AND COULD THEN BE USED CONSISTENT WITH AN APPROPRIATE SOP IN THE CLIA LAB?

1118

MR. WADE: FOR PATIENT USE?

1120

MR. WADE: AND BY -- DO YOU SEE THAT THERE ARE SEVERAL PEOPLE WHO AFFIX THEIR SIGNATURE TO THESE DOCUMENTS?

1122

MR. WADE: AND THOSE ARE OTHER PEOPLE WHO WORKED ON THE DEVELOPMENT OF THESE REPORTS?

1124

MR. WADE: OTHER SCIENTISTS AND THE LIKE?

1126

MR. WADE: BUT ULTIMATELY YOU'RE THE APPROVER OF THESE POLICIES?

1127

ADAM ROSENDORFF: I'M -- I APPROVED THE REPORT, YES.

1129

ADAM ROSENDORFF: IT'S NOT A POLICY DOCUMENT.

1130

MR. WADE: IT'S A DOCUMENT THAT VALIDATES THE TEST AS APPROPRIATE FOR PATIENT USE?

1132

MR. WADE: OKAY. AND IS IT FAIR TO DESCRIBE THIS AS THE TICKET FOR ADMISSION INTO THE CLIA LAB?

1134

MR. WADE: OKAY. WITHOUT ONE OF THESE DOCUMENTS, THERE IS NOT A --

1135

ADAM ROSENDORFF: IT'S A REQUIRED, IT'S A REQUIRED ELEMENT FOR -- TO BEGIN LAB TESTING. AS I HAVE TESTIFIED BEFORE, THERE ARE A NUMBER OF OTHER ELEMENTS, SUCH AS TRAINING, INSTRUMENT MAINTENANCE, ET CETERA. CHECKING ON THOSE WOULD BE DELEGATED TO THE SUPERVISORS.

1137

ADAM ROSENDORFF: IN OTHER WORDS, IF THEY SAW A PROBLEM IN ANY OF THOSE AREAS, THEN THERE WOULD NOT BE TESTING.

1138

MR. WADE: OKAY. UNDERSTOOD. BUT THE POINT I JUST WANT TO MAKE SURE OF, AND I THINK WE'RE IN AGREEMENT HERE, IS THAT IF YOU DON'T HAVE ONE OF THESE DOCUMENTS, YOU CANNOT OFFER THE ASSAY WITHIN THE CLIA LAB; CORRECT?

1140

MR. WADE: AND IF THEY DON'T HAVE YOUR SIGNATURE ON THE DOCUMENT WHEN YOU'RE THE LAB DIRECTOR, THAT ASSAY CANNOT GO INTO THE CLIA LAB; CORRECT?

1142

MR. WADE: AND THIS PARTICULAR ONE CAME IN SEPTEMBER, LATE SEPTEMBER OF 2013; RIGHT?

1144

MR. WADE: OKAY. LET'S WALK THROUGH JUST ONE OF THESE IN A LITTLE MORE DETAIL SO WE CAN MAKE SURE THAT WE UNDERSTAND THIS. IF YOU CAN GO TO PAGE 5 OF THE DOCUMENT, AND IF WE CAN GO UP TO THE ASSAY SPECIFICATIONS. THIS GIVES SORT OF THE OVERVIEW OF THE ASSAY AND AN OVERVIEW OF THE PROCESS OF VALIDATION. IS THAT FAIR?

1145

ADAM ROSENDORFF: IT'S CLINICAL BACKGROUND, AND THAT'S 1.1; NUMBER 1.2 IS THE ASSAY SPECIFICATIONS THAT HAVE BEEN DEMONSTRATED; AND 1.3 IS THE COMPARATOR OR REFERENCE ASSAY THAT WAS USED TO VALIDATE THIS TEST.

1146

MR. WADE: AND DO YOU UNDERSTAND -- I THINK YOU TESTIFIED YESTERDAY, A LOT OF THE UNDERLYING DATA WORK HAD BEEN PERFORMED IN A RESEARCH AND DEVELOPMENT FUNCTION?

1148

MR. WADE: AND THEN IT WAS BROUGHT INTO THE CLIA LAB AND TESTED BY YOU AND YOUR COLLEAGUES?

1150

MR. WADE: OKAY. DO YOU SEE AT THE BOTTOM WHERE IT SAYS REGULATION AND GUIDANCE?

1152

MR. WADE: OKAY. AND DO YOU SEE IT SAYS, "THE QUALIFICATION/VALIDATION OF THE ELISA ASSAYS ON THE THERANOS DEVICE WILL BE IN ACCORDANCE WITH 493.1253." DO YOU SEE THAT?

1154

MR. WADE: AND THAT'S ACTUALLY, THAT'S THE SAME PROVISION THAT YOU HAD, YOU HAD CUT AND PASTED INTO THAT EMAIL TO MR. BALWANI; RIGHT?

1156

MR. WADE: AND YOU HAD SAID THAT THERE WAS ONE ELEMENT OF THAT THAT HADN'T BEEN MET AND THAT YOU WANTED TO HAVE MET?

1158

MR. WADE: OKAY. BUT THOSE, THOSE ARE SORT OF THE REGULATORY REQUIREMENTS BEFORE YOU CAN, YOU CAN OFFER AN ASSAY WITHIN THE CLIA LAB?

1160

MR. WADE: AND YOU NEEDED TO ENSURE THAT IT MET THAT REQUIREMENT; RIGHT?

1162

MR. WADE: OKAY. AND YOU DID ENSURE THAT; RIGHT?

1164

MR. WADE: AND IF WE CAN MOVE FORWARD IN THE DOCUMENT TO PAGE 8. DO YOU SEE THE DATA ON THE BOTTOM? AND THIS IS PART OF THE CALIBRATION WORK THAT WAS DONE?

1166

MR. WADE: WELL, LET ME BACK UP TO PAGE 6 TO MAKE SURE THAT I'M GUIDING YOU CORRECTLY. DO YOU SEE SECTION 2 IS CALIBRATION?

1168

MR. WADE: AND CALIBRATION OF THE INSTRUMENT WAS SOMETHING THAT WAS NECESSARY IN ORDER FOR IT TO GET VALIDATED; CORRECT?

1170

MR. WADE: AND IT IS SOMETHING THAT NEEDED TO BE DOCUMENTED WITHIN THIS REPORT; RIGHT?

1172

MR. WADE: OKAY. AND THEN ALL OF THAT DETAILED DATA IS LAID FORTH WITHIN THAT REPORT ITSELF; CORRECT?

1174

MR. WADE: AND LET'S GO FORWARD TO PAGE 8. THERE ARE A NUMBER OF TABLES THAT SUMMARIZE THAT CALIBRATION DATA; RIGHT?

1176

MR. WADE: AND WHAT DOES THAT TABLE ON THE BOTTOM OF PAGE 8 DO?

1177

ADAM ROSENDORFF: SO IT'S TAKING THE DATA FOR EACH CALIBRATOR AND IT'S TRANSLATING INTO AN ACTUAL ANALYTE CONCENTRATION. AND THE NOMINAL CONCENTRATION IS HOW MUCH IS IN THAT, EACH CALIBRATOR, AND THE THERANOS CONCENTRATION IS HOW MUCH IS BEING REPORTED OUT BY THE INSTRUMENT.

1178

MR. WADE: OKAY. AND THAT IS SOMETHING THAT IS ASSESSED BEFORE IT CAN BE USED; RIGHT?

1180

MR. WADE: OKAY. AND IF YOU LOOK AT THE NEXT SEVERAL PAGES, THERE'S -- I BELIEVE THERE'S MORE CALIBRATION DATA; CORRECT?

1182

MR. WADE: OKAY. LET'S GO TO PAGE 15. AND DO YOU SEE PAGE 15, SECTION 4 OF EXHIBIT 9368 REFERENCES THE REFERENCE RANGE?

1184

MR. WADE: AND A REFERENCE RANGE NEEDS TO BE CREATED UNDER THE REGULATORY STANDARDS; CORRECT?

1186

MR. WADE: AND THAT REQUIRES, THAT REQUIRES DATA ANALYSIS RELATING TO SOME OF THE RESULTS THAT HAVE BEEN OBTAINED; CORRECT?

1188

MR. WADE: OKAY. AND THAT'S WHAT IS DOCUMENTED WITHIN THIS REPORT; RIGHT?

1189

ADAM ROSENDORFF: YEAH. THIS IS A VERIFICATION OF THE REFERENCE RANGE USING 20 FINGERSTICK SAMPLES FROM NORMAL DONORS.

1190

MR. WADE: OKAY. AND LET'S GO TO PAGE 17. DO YOU SEE ON THE BOTTOM THERE THERE'S A REFERENCE TO PRECISION?

1192

MR. WADE: AND PRECISION IS SOMETIMES A PROXY FOR RELIABILITY; IS THAT RIGHT?

1193

ADAM ROSENDORFF: RELIABILITY IS NOT DEFINED IN ANY REGULATORY OR GUIDANCE DOCUMENT.

1194

MR. WADE: OKAY. IT'S, IT'S A MATTER THAT IS LEFT TO THE JUDGMENT OF THE LABORATORY DIRECTOR?

1195

ADAM ROSENDORFF: SO THERE'S SOMETHING CALLED ALLOWABLE ERROR FOR AN ASSAY.

1196

MR. WADE: TOTAL ALLOWABLE ERROR?

1197

ADAM ROSENDORFF: TOTAL ALLOWABLE ERROR, YEAH.

1198

MR. WADE: AND SOMETIMES REFERRED TO AS TAE?

1200

MR. WADE: AND YOU SOMETIMES LOOK AT THAT; RIGHT?

1202

MR. WADE: AND YOU ALSO LOOK AT PRECISION DATA I THINK WE HAVE SEEN IN SOME OF THE EMAILS; RIGHT?

1203

ADAM ROSENDORFF: PRECISION IS REPRODUCIBILITY.

1204

MR. WADE: AND IT'S CONSISTENCY DATA ESSENTIALLY; RIGHT?

1206

MR. WADE: THE FREQUENCY WITH WHICH THE TESTING CAN TEST THE SAME SAMPLE AND GET THE SAME NUMBER EVERY TIME?

1208

MR. WADE: SO, LIKE, FOR EXAMPLE --

1209

ADAM ROSENDORFF: IT'S NEVER GOING TO GET THE SAME NUMBER BECAUSE THERE'S INHERENT VARIABILITY IN THE PROCESS. BUT YOU'LL GET VALUES IDEALLY THAT ARE CLOSE TO EACH OTHER.

1211

ADAM ROSENDORFF: HOW CLOSE THEY ARE IS PREDEFINED BY THE LABORATORY, HOW CLOSE THEY NEED TO BE.

1212

MR. WADE: AND YOU SAY IT'S NEVER GOING TO HIT THE SAME NUMBER BECAUSE IT'S THE SAME BLOOD; RIGHT?

1214

MR. WADE: AND IT TYPICALLY HAS THE SAME AMOUNT OF AN ANALYTE WITHIN IT; RIGHT?

1216

MR. WADE: AND BECAUSE OF INSTRUMENTATION AND OTHER FACTORS, THERE'S WHAT YOU DESCRIBED AS VARIABILITY; RIGHT?

1217

ADAM ROSENDORFF: RIGHT. BUT YOU ALSO HAVE TO BEAR IN MIND THAT IT'S NOT NECESSARILY -- IF THE ANALYTE IS AT VERY LOW ABUNDANCE, THE FIRST TIME YOU TAKE AN ALIQUOT YOU MIGHT GET TEN MOLECULES, AND THE NEXT TIME YOU TAKE AN ALIQUOT YOU MIGHT GET EIGHT MOLECULES.

1218

MR. WADE: AND ALL OF THAT CAN AFFECT THE RESULT AS QUANTIFIED BY THE TEST; RIGHT?

1220

MR. WADE: AND SO -- BUT THE IDEA OF PRECISION IS TO TEST THE FREQUENCY WITH WHICH, IF YOU PERFORM THE SAME PROCEDURE, YOU CAN GET THE SAME NUMBER; RIGHT? THAT'S THE GOAL?

1221

ADAM ROSENDORFF: IT'S NOT THE SAME NUMBER. I'VE ALREADY EXPLAINED THAT TO YOU.

1223

ADAM ROSENDORFF: THE NUMBERS ARE SUFFICIENTLY CLOSE TO EACH OTHER AS DEFINED BY A STANDARD DEVIATION.

1225

ADAM ROSENDORFF: RELATIVE TO THE MEAN OF THOSE NUMBERS. AND THAT GIVES YOU A CV PERCENTAGE, AND THAT HAS TO MEET PREDEFINED LABORATORY CRITERIA.

1226

MR. WADE: OKAY. LET ME SEE IF I CAN LIKEN THE CONCEPT TO A DAY-TO-DAY EXPERIENCE. IF THERE WAS A SCALE AND I WERE TO GET UP ON THE SCALE AT THE SAME TIME, THAT SCALE MIGHT SAY 145 POUNDS; RIGHT? THE NEXT TIME IT MIGHT SAY 145.3. THE NEXT TIME IT MIGHT SAY 144.7; RIGHT? IT WOULD DEPEND UPON THE PRECISION OF THE SCALE. RIGHT?

1228

MR. WADE: AND THAT VARIABILITY FROM RESULT TO RESULT IS JUST SORT OF THE NATURE OF THE INSTRUMENTATION?

1229

ADAM ROSENDORFF: THAT'S ONE FACTOR, YES.

1230

MR. WADE: RIGHT. AND IT'S HARD TO KNOW WITH CERTAINTY THE SORT OF TRUE MEASURE OF THE ACTUAL ANALYTE WITHIN BLOOD; RIGHT?

1231

ADAM ROSENDORFF: WELL, THIS GETS INTO A COMPLICATED DISCUSSION THAT IS PROBABLY NOT APPROPRIATE FOR RIGHT NOW, YEAH. IT GETS INTO THE DISCUSSION OF NUTROLOGY, WHAT A TRUE VALUE IS, BIOLOGICAL TRUE VALUE, THE GOLD STANDARD, ET CETERA.

1232

MR. WADE: AND THE GOLD STANDARDS ARE SORT OF AN ESTABLISHED ASSAY AGAINST WHICH ASSAYS ARE FREQUENTLY MEASURED; RIGHT?

1234

MR. WADE: AND THAT'S PART OF A VALIDATION PROCESS; RIGHT?

1236

MR. WADE: AND LET'S GO BACK TO THE DOCUMENT AND LOOK AT PAGE 20. THIS IS SECTION 5 OF THE REPORT. DOCTOR, I DON'T WANT TO WALK THROUGH ALL THESE REPORTS, BUT AS A GENERAL MATTER, THESE ARE KIND OF SIMILAR DOCUMENTS; RIGHT? THEY LOOK AT THE SAME ELEMENTS; IS THAT RIGHT?

1238

MR. WADE: AND THIS SETS FORTH ACCURACY. DO YOU SEE THAT?

1240

MR. WADE: AND WHAT IS DONE TO ASSESS THE ACCURACY OF THE ASSAY BEFORE IT'S PUT WITHIN THE CLIA LAB?

1241

ADAM ROSENDORFF: A NUMBER OF SAMPLES, PATIENT SAMPLES, ARE COLLECTED. FOR THE ACCURACY SECTION, THIS WOULD BE VENOUS BLOOD. THEY'RE UNIQUE PATIENT SAMPLES. IN THIS CASE THERE WERE 103 COLLECTED, AND SOME WERE BELOW THE REFERENCE RANGE AND SOME OF THEM WERE ABOVE THE REFERENCE RANGE SO THAT YOU MAKE SURE YOU'RE CAPTURING BOTH THE NORMAL AND PATHOLOGICAL STATES. THOSE SAMPLES WOULD BE RUN ON A THERANOS METHOD AND A PREDICATE METHOD, IN THIS CASE THE IMMULITE.

1243

ADAM ROSENDORFF: AND THEN YOU COMPARE THOSE DATA AND IDEALLY YOU PLOT THEM AGAINST EACH OTHER AND THERE SHOULD BE A LINEAR ONE-TO-ONE RELATIONSHIP BETWEEN THOSE NUMBERS.

1244

MR. WADE: OKAY. AND THERE OFTEN IS NOT A LINEAR ONE-TO-ONE RATIO, BUT IT NEEDS TO BE WITHIN A CERTAIN RANGE OF ONE-TO-ONE; RIGHT?

1246

MR. WADE: AND LET ME SEE IF I CAN UNPACK THAT A LITTLE BIT JUST FOR CLARIFICATION FOR NONSCIENTISTS LIKE ME. OKAY?

1248

MR. WADE: IS THE IMMULITE COMPARATOR IN THAT, IS THAT THE GOLD STANDARD AGAINST WHICH YOU'RE MEASURING THE PERFORMANCE?

1249

ADAM ROSENDORFF: IN THIS CASE, YES.

1250

MR. WADE: SO THE GOLD STANDARD IS AN EXISTING COMMERCIAL MACHINE; RIGHT?

1252

MR. WADE: AND THAT'S APPROVED BY THE FDA; CORRECT?

1254

MR. WADE: AND YOU LOOK AT THAT RESULT, AND THEN YOU TAKE THE SAME BLOOD AND YOU RUN IT ON THE THERANOS MACHINE?

1256

MR. WADE: OKAY. AND THEN YOU COMPARE THE RESULTS OF ONE TO THE OTHER; RIGHT?

1258

MR. WADE: AND WHAT YOU SAID IS THAT YOU DON'T WANT TO JUST HAVE NORMAL RESULTS TO COMPARE, LIKE THE AVERAGE?

1260

MR. WADE: YOU WANT TO MAKE SURE IF SOMEONE HAS, FOR EXAMPLE, AN ELEVATED VITAMIN D LEVEL, THAT IT TESTS THE SAME ON BOTH MACHINES; RIGHT?

1262

MR. WADE: OKAY. AND SIMILARLY, IF THEY HAVE A LOW VITAMIN D LEVEL --

1264

MR. WADE: -- THAT THEY TEST THE SAME ON BOTH MACHINES; IS THAT CORRECT?

1266

MR. WADE: AND WHEN YOU'RE ASSESSING THE ACCURACY OF A TEST, THAT'S WHAT YOU'RE DOING, YOU'RE COMPARING THERANOS'S PERFORMANCE AGAINST A WELL ESTABLISHED FDA APPROVED MACHINE; RIGHT?

1268

MR. WADE: OKAY. AND IT'S ONLY WHEN THAT GETS WITHIN AN ALLOWABLE RELATIONSHIP THAT IT'S DEEMED SUFFICIENTLY ACCURATE TO BE OFFERED IN A LAB; RIGHT?

1269

ADAM ROSENDORFF: YES. THERE'S A, THERE'S A BIAS -- THERE'S A TOTAL ALLOWABLE ERROR THAT IS THE SUM OF THE PRECISION IN THE BIAS THAT CANNOT BE EXCEEDED. SO YOU REALLY LOOK AT THE PERCENT DIFFERENCE IN THE PREDICATE AND THERANOS METHODS, THAT'S YOUR BIAS, AND THEN YOU LOOK AT YOUR CV'S, THAT'S YOUR PRECISION, AND YOU ADD THOSE TOGETHER, AND THEY HAVE TO BE WITHIN THE TOTAL ALLOWABLE ERROR, YEAH.

1270

MR. WADE: AND THE BIAS IS THE AMOUNT OF WHICH ONE RESULT IS OFF FROM THE GOLD STANDARD; RIGHT?

1272

MR. WADE: ON AVERAGE?

1274

MR. WADE: AND SO IF THE GOLD STANDARD IS THE BULL'S EYE IN THE TARGET, IT'S THE AMOUNT THAT THE ARROW HITS JUST OUTSIDE OF THAT TARGET; RIGHT? IT'S A MEASUREMENT AKIN TO SOMETHING LIKE THAT?

1276

MR. WADE: OKAY. AND IF THE ARROW HITS, YOU KNOW, WAY OFF THE TARGET THREE TIMES, YOU PROBABLY HAVE A PROBLEM AND IT'S NOT GOING TO BE SUFFICIENTLY ACCURATE; RIGHT?

1277

ADAM ROSENDORFF: WELL, YOU'RE LOOKING AT AVERAGE BIAS, SO --

1278

MR. WADE: SO YOU COMPUTE THOSE ITEMS WITHIN THE TOTAL RANGE? THE TOTALITY OF THE GROUP OF TESTS HAS TO BE SUFFICIENTLY CLOSE TO THAT BULL'S EYE --

1280

MR. WADE: -- TO BE CONSIDERED ACCURATE FOR PATIENT USE; RIGHT?

1281

ADAM ROSENDORFF: EACH -- SO IF YOU LOOK AT TABLE 12, YOU KNOW, EACH -- THERE'S A --

1282

MR. WADE: COULD WE PULL UP TABLE 12 FOR THE JURY, PLEASE. THAT'S ON PAGE 21. SHOULD WE BLOW UP THE TOP, DOCTOR?

1284

MR. WADE: OKAY. LET'S BLOW UP THE TOP.

1285

ADAM ROSENDORFF: YOU SEE THAT THE THERANOS RESULTS ARE FAIRLY CLOSE TO THE IMMULITE RESULTS. THE IMMULITE RESULTS ARE SHOWING AS REPORTED VALUE, AND THE RECOVERIES FOR THE MOST PART ARE CLOSE TO 100 PERCENT WITH A FEW EXCEPTIONS, RIGHT? TSH 09, THE RECOVERY IS ONLY 54 PERCENT, AND FOR TSH 17, THE RECOVERY IS 200 PERCENT. ALL OF THAT GETS AVERAGED OUT IN A BIAS CALCULATION.

1286

MR. WADE: AND THAT'S WHY YOU HAVE A UNIVERSE OF DATA AND YOU -- IN AGGREGATE, THEY HAVE TO HIT THE TARGET OR BE SUFFICIENTLY CLOSE TO THE TARGET; CORRECT?

1288

MR. WADE: AND IT'S ONLY WHEN THAT HAPPENS AND IT'S DEEMED SUFFICIENTLY ACCURATE THAT IT CAN GO INTO THE LAB; RIGHT?

1290

MR. WADE: LET'S GO TO PAGE 25 AND BLOW UP FIGURE 8. OKAY. DO YOU SEE, DO YOU SEE THIS CHART?

1292

MR. WADE: OKAY. AND IS THIS THE MEASUREMENT OF ACCURACY THAT THE -- THE QUANTIFICATION OF THE MEASUREMENT OF ACCURACY THAT YOU WERE TALKING ABOUT?

1293

ADAM ROSENDORFF: NO. THIS IS A PLOT. ON THE X AXIS YOU HAVE THE PREDICATE RESULTS, AND ON THE Y AXIS YOU HAVE THE THERANOS RESULTS. EACH DATA POINT IS -- SO THE RESULT -- THOSE TWO VALUES GENERATED THE POINT THAT YOU'RE SEEING ON THE GRAPH, AND THEN WHAT IS CALLED A LINEAR REGRESSION IS PERFORMED WHICH GENERATES A FORMULA THAT RELATES THE ONE RESULT TO THE OTHER, AND THAT'S Y EQUALS 0.9748X, AND THEN AN R SQUARED VALUE, WHICH IS STATISTICAL ESTIMATES OF THE CORRELATION, HOW WELL CORRELATED THOSE RESULTS ARE TO EACH OTHER.

1294

MR. WADE: AND THAT R SQUARED THERE --

1296

MR. WADE: -- WHICH IS .9205. DO YOU SEE THAT?

1298

MR. WADE: AND YOU SAID PERFECT IS 1.0; CORRECT?

1300

MR. WADE: AND THERE'S RARELY PERFECT; RIGHT?

1302

MR. WADE: AND IT'S A QUESTION OF WHETHER THAT NUMBER IS CLOSE ENOUGH TO 1; IS THAT RIGHT?

1303

ADAM ROSENDORFF: CORRECT, CORRECT.

1304

MR. WADE: AND IN THIS CASE IT WAS?

1305

ADAM ROSENDORFF: CORRECT. I'D LIKE TO POINT OUT SOMETHING. I'LL SHUT UP BECAUSE I'M NOT BEING ASKED A QUESTION.

1306

MR. WADE: WE'LL KEEP GOING. WE'RE GOING TO TAKE A BREAK HERE IN A SECOND. IF WE GO TO 8 -- I'M SORRY, PAGE 36, SECTION 8. THIS IS -- THERE'S A DETAILED SECTION HERE OF DATA RELATING TO ANTICOAGULANT COMPARISON; RIGHT? DO YOU SEE THAT?

1307

ADAM ROSENDORFF: JUST GIVE ME A MOMENT TO READ IT, PLEASE.

1308

(PAUSE IN PROCEEDINGS.)

1310

BY MR. WADE:

1311

MR. WADE: AND THIS IS ONE OF THE REQUIREMENTS. YOU NEED TO MAKE THE ASSESSMENT BEFORE THE ASSAY CAN BE VALIDATED?

1313

MR. WADE: OKAY. THAT'S THE ONLY QUESTION THAT I HAVE ON THAT. IF WE CAN GO TO 42 AND LOOK AT SECTION 9. I THINK WE TALKED A LITTLE BIT EARLIER ABOUT SENSITIVITY. DO YOU RECALL THAT?

1315

MR. WADE: THAT WAS AN ISSUE THAT YOU RAISED?

1317

MR. WADE: AND YOU WANTED TO MAKE SURE THAT SENSITIVITY WAS PROPERLY DOCUMENTED; RIGHT?

1318

ADAM ROSENDORFF: VALIDATED AND DOCUMENTED, YES.

1319

MR. WADE: OKAY. AND THIS IS THE SECTION OF THE REPORT THAT DOES THAT; RIGHT?

1321

MR. WADE: OKAY. AND THE PAGES THAT FOLLOW HAVE THE DETAILED DATA RELATING TO THAT?

1323

MR. WADE: OKAY. AND LET'S GO TO PAGE 46. SECTION 10 IS INTERFERENCE; IS THAT RIGHT?

1325

MR. WADE: OKAY. AND EXPLAIN TO US WHAT IS DONE TO ASSESS INTERFERENCES IN CONNECTION WITH THE VALIDATION OF AN ASSAY GENERALLY.

1326

ADAM ROSENDORFF: COMMERCIALLY AVAILABLE INTERFERING SUBSTANCES. IN THIS CASE HEMOGLOBIN, BILIRUBIN, AND TRIGLYCERIDES WERE ADDED TO BLOOD AND YOU COMPARE THE VALUES YOU GET WITH THE INTERFERING SUBSTANCES ADDED -- YOU COMPARE THE VALUES YOU GET FOR SAMPLES WITHOUT THE INTERFERING SUBSTANCES TO VALUES THAT YOU GET WITH THE INTERFERING SUBSTANCES AND YOU DETERMINE WHAT -- HOW MUCH INTERFERENCE IS THERE.

1327

MR. WADE: AND THAT'S TO ENSURE THAT THOSE INTERFERING SUBSTANCES DON'T GET IN THE WAY OF AN ACCURATE RESULT?

1329

MR. WADE: OKAY. SO YOU BASICALLY ADD IN ELEMENTS TO SEE IF IT TRICKS THE TEST TO GIVING A BAD RESULT?

1331

MR. WADE: OKAY. BECAUSE SOME OF THOSE ELEMENTS THAT YOU ADD INTO THE SAMPLE ACTUALLY DO EXIST IN OTHER PEOPLE'S BLOOD; RIGHT?

1332

ADAM ROSENDORFF: ALL OF THESE DO.

1333

MR. WADE: ALL OF THEM DO?

1335

MR. WADE: SO YOU WANT TO MAKE SURE WHEN THE TEST GOES OUT IN THE FIELD AND THERE ARE DIFFERENT INTERFERING SUBSTANCES, THAT YOU'RE STILL ABLE TO GET AN ACCURATE RESULT?

1337

MR. WADE: OKAY. AND IF I COULD, JUST FINALLY ON THIS DOCUMENT, BRING YOU TO THE LAST PAGE, WHICH IS PAGE 51. AND DO YOU SEE THIS DOCUMENT REFERENCES THE MANY DIFFERENT MATERIALS THAT HAVE GONE INTO THE WORK AND ANALYSIS RELATING TO THIS ASSAY. DO YOU SEE THAT?

1339

MR. WADE: AND MANY OF THESE ARE SPECIFICALLY CITED WITHIN THE REPORT?

1341

MR. WADE: AND DIFFERENT SCIENTISTS OVER TIME REFER TO THESE AS STANDARDS AND INFORMATION TO CONSIDER?

1343

MR. WADE: AND I TAKE IT, GENERALLY SPEAKING, IF I WERE TO PRINT OUT ALL OF THESE MATERIALS, I WOULD PROBABLY HAVE TO HAND YOU ANOTHER ONE OF THESE BINDERS; IS THAT RIGHT?

1344

ADAM ROSENDORFF: YEAH. PLEASE DON'T.

1345

MR. WADE: OKAY. WITH THAT, YOUR HONOR, MAY WE TAKE A BREAK?

1346

JUDGE DAVILA: LET'S DO THAT. WHY DON'T WE TAKE 45 MINUTES, AND WE'LL COME BACK AT NOON. WE'LL GO THEN, LADIES AND GENTLEMEN, UNTIL 2:00 AND TAKE A BREAK, AND THEN WE'LL FINISH AT 4:00. HAVE A GOOD LUNCH.

1347

(LUNCH RECESS AT 11:12 A.M.) AFTERNOON SESSION

1348

(JURY IN AT 12:02 P.M.)

1349

JUDGE DAVILA: THANK YOU. WE'RE BACK ON THE RECORD. THE JURY AND ALTERNATES ARE PRESENT. COUNSEL AND MS. HOLMES IS PRESENT. OUR WITNESS IS ON THE STAND. YOU'D LIKE TO CONTINUE WITH YOUR EXAMINATION?

1350

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

1351

MR. WADE: DR. ROSENDORFF, I BELIEVE BEFORE THE BREAK WE WERE TALKING ABOUT VALIDATION REPORTS. DO YOU RECALL THAT?

1353

MR. WADE: AND I'D LIKE TO GO TO OUR NEXT VALIDATION REPORT, AND IT'S WITHIN THAT BOOK, 9387.

1354

ADAM ROSENDORFF: OKAY. I HAVE IT.

1355

MR. WADE: IT'S IN EVIDENCE PER STIPULATION. IF WE CAN PUBLISH IT.

1356

(DEFENDANT'S EXHIBIT 9387 WAS RECEIVED IN EVIDENCE.)

1357

BY MR. WADE:

1358

MR. WADE: AND CAN YOU IDENTIFY THE ASSAY FOR WHICH THIS WAS A VALIDATION REPORT AND THE DEVICE ON WHICH IT WAS VALIDATED?

1359

ADAM ROSENDORFF: THE ASSAY IS TPSA, WHICH IS TOTAL PROSTATE SPECIFIC ANTIGEN FOR THE EDISON 3.X SYSTEM.

1360

MR. WADE: AND THIS WAS AN EDISON ASSAY; CORRECT?

1362

MR. WADE: AND YOU SIGNED THIS VALIDATION REPORT ON SEPTEMBER 30TH, 2013?

1364

MR. WADE: AND YOU BELIEVED THIS ASSAY TO APPROPRIATELY QUALIFY FOR VALIDATION UNDER THE RULES AND REGULATIONS WE'VE BEEN PREVIOUSLY REVIEWING IN CONNECTION WITH THAT?

1365

ADAM ROSENDORFF: YES, AND THE ASSAY MET THOSE REQUIREMENTS.

1367

ADAM ROSENDORFF: THE VALIDATION, I'M SORRY.

1368

MR. WADE: AND THREE OF YOUR COLLEAGUES ALSO SIGNED OFF ON THAT AS WELL?

1370

MR. WADE: IF WE COULD GO TO THE NEXT VALIDATION REPORT, WHICH IS 9412. THIS IS IN EVIDENCE PER STIPULATION, AND WE'RE PUBLISHING IT. THIS IS THE VITAMIN D ASSAY VALIDATION REPORT ON THE EDISON 3 SERIES DEVICE; IS THAT RIGHT?

1372

MR. WADE: AND THIS, TOO, IS SIGNED ON SEPTEMBER 30TH, 2013?

1374

MR. WADE: AND IT'S ALSO SIGNED BY THREE OF YOUR COLLEAGUES?

1376

MR. WADE: AND IS IT SIGNED BECAUSE YOU BELIEVED AT THE TIME THIS WAS PRESENTED TO YOU THAT IT QUALIFIED, ACCORDING TO ALL OF THE REQUIREMENTS NECESSARY TO OFFER A TEST IN THE CLIA LAB?

1377

ADAM ROSENDORFF: YES, THAT WAS MY BELIEF.

1378

MR. WADE: IF WE CAN GO TO THE NEXT VALIDATION REPORT, WHICH IS 9381, WHICH IS ALSO IN EVIDENCE PER STIPULATION. WE'RE PUBLISHING THAT. THIS IS THE TOTAL T4 ELISA ASSAY VALIDATION REPORT ON THE EDISON 3.5 THERANOS SYSTEM; IS THAT RIGHT?

1380

MR. WADE: AND IT IS EFFECTIVE JANUARY 10TH, 2014; IS THAT CORRECT?

1382

MR. WADE: AND AS WITH THE PRIOR REPORTS, YOU SIGNED --

1383

ADAM ROSENDORFF: POINT OF CLARIFICATION. I SIGNED IT ON THE 14TH. I'M NOT SURE WHY THE EFFECTIVE DATE IS PRIOR TO THAT.

1384

MR. WADE: IS IT POSSIBLE THAT IT HAD BEEN REVIEWED OR SOMETHING PREVIOUSLY?

1385

ADAM ROSENDORFF: I DON'T RECALL.

1386

MR. WADE: OKAY. WELL, YOU SIGNED IT ON THE 14TH; IS THAT CORRECT?

1388

MR. WADE: AND AS OF AT LEAST JANUARY 14TH, 2014, DID YOU BELIEVE IT TO BE -- DID YOU BELIEVE THAT THIS VALIDATION REPORT MET ALL OF THE APPROPRIATE REQUIREMENTS?

1390

MR. WADE: AND DID YOU BELIEVE THEN IT WAS APPROPRIATE TO OFFER THIS ASSAY WITHIN THE CLIA LAB?

1392

MR. WADE: OKAY. IF WE CAN GO TO THE NEXT VALIDATION REPORT, WHICH IS 9382, WHICH IS ALSO IN EVIDENCE BY STIPULATION. WE'RE LOOKING AT THE TOTAL TESTOSTERONE ELISA ASSAY VALIDATION REPORT ON THE EDISON 3.5 THERANOS SYSTEM; CORRECT?

1394

MR. WADE: AND THIS SAYS THAT YOU SIGNED THAT DOCUMENT ON JANUARY 15TH, 2014; IS THAT CORRECT?

1396

MR. WADE: AND IN SIGNING THAT DOCUMENT, YOU'RE RECOGNIZING THAT THAT ASSAY WAS APPROPRIATE TO BE OFFERED WITHIN THE CLIA LAB?

1398

MR. WADE: AND THAT IT MET ALL OF THE APPROPRIATE LEGAL REQUIREMENTS; CORRECT?

1400

MR. WADE: IF WE CAN GO NEXT TO 9384. SINCE THERE'S A BIG WORD IN THIS ONE I'M GOING TO HAVE YOU PRONOUNCE IT. CAN YOU TELL US THIS ASSAY?

1401

ADAM ROSENDORFF: SURE. TOTAL TRIIODOTHYRONINE ASSAY.

1402

MR. WADE: AND DOES THAT HAVE A SHORT -- IS THAT REFERRED TO AS SOMETHING BY AN ABBREVIATED NAME?

1404

MR. WADE: T3. THIS IS THE T3 ELISA ASSAY VALIDATION REPORT ON THE EDISON 3 SERIES THERANOS SYSTEM?

1406

MR. WADE: AND YOU SIGNED THIS DOCUMENT ON JANUARY 20 -- I'M SORRY, JANUARY 15TH, 2014?

1408

MR. WADE: AND YOUR COLLEAGUES SIGNED THIS AS WELL?

1410

MR. WADE: AND IN SIGNING THIS, YOU WERE CERTIFYING THAT THIS ASSAY WAS APPROPRIATE FOR USE ON PATIENTS WITHIN THE CLIA LAB?

1412

MR. WADE: AND THAT IT MET ALL OF THE APPROPRIATE REQUIREMENTS?

1414

MR. WADE: I'LL MOVE TO THE NEXT REPORT, WHICH IS 9196. THIS IS THE HCG ELISA ASSAY VALIDATION REPORT ON THE EDISON 3.5 THERANOS SYSTEM?

1415

ADAM ROSENDORFF: IF YOU'LL ALLOW ME A FEW MOMENTS. 9186?

1416

MR. WADE: OH, MY APOLOGIES, DOCTOR.

1418

MR. WADE: 9196, WHICH IS EVIDENCE PER STIPULATION.

1420

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

1422

MR. WADE: OKAY. THIS IS THE HCG ELISA ASSAY VALIDATION REPORT ON THE EDISON 3.5 THERANOS SYSTEM?

1424

MR. WADE: AND IT'S SIGNED BY YOU ON MARCH 19TH, 2014; CORRECT?

1426

MR. WADE: AND IT'S SIGNED BY THREE OF YOUR COLLEAGUES AS WELL?

1428

MR. WADE: AND YOU SIGNED THAT BECAUSE YOU THOUGHT IT WAS APPROPRIATE TO OFFER THIS ASSAY ON THE EDISON DEVICE IN THE CLIA LAB; CORRECT?

1429

ADAM ROSENDORFF: AT THE TIME, YES.

1430

MR. WADE: AND THAT IT MET ALL OF THE REQUIREMENTS TO BE OFFERED IN THE CLIA LAB ON MARCH 19TH, 2014; CORRECT?

1432

MR. WADE: IF I CAN GO TO EXHIBIT 9409, WHICH IS IN EVIDENCE PER STIPULATION. DO YOU HAVE THAT IN FRONT OF YOU, DOCTOR?

1434

MR. WADE: AND THIS IS THE VITAMIN B12 ELISA ASSAY VALIDATION REPORT?

1435

ADAM ROSENDORFF: CORRECT, YES.

1436

MR. WADE: ON THE EDISON 3.5 THERANOS SYSTEM?

1438

MR. WADE: AND YOU SIGNED THIS DOCUMENT ON AUGUST 5TH, 2014?

1440

MR. WADE: AND IT WAS SIGNED BY NINE OF YOUR COLLEAGUES AS WELL?

1442

MR. WADE: AND IN SIGNING THIS, YOU WERE RECOGNIZING THAT THIS ASSAY WAS -- HAD MET ALL OF THE REQUIREMENTS UNDER CLIA?

1444

MR. WADE: AND THAT IT WAS APPROPRIATE TO BE OFFERED IN USE WITH PATIENTS IN THE CLIA LAB?

1446

MR. WADE: OKAY. IF WE CAN GO TO 9323, WHICH IS IN EVIDENCE PER STIPULATION.

1448

MR. WADE: AND THIS IS THE PROLACTIN ELISA ASSAY VALIDATION REPORT ON THE EDISON 3.5 THERANOS SYSTEM; IS THAT CORRECT?

1450

MR. WADE: AND YOU SIGNED THIS DOCUMENT SEPTEMBER 9TH, 2014?

1452

MR. WADE: AND IT WAS SIGNED BY FIVE OF YOUR COLLEAGUES; CORRECT?

1454

MR. WADE: AND YOU SIGNED THIS BECAUSE YOU BELIEVED THAT IT MET ALL OF THE LEGAL REQUIREMENTS AND WAS APPROPRIATE TO BE OFFERED AND USED WITH PATIENTS IN THE CLIA LAB; IS THAT CORRECT?

1456

MR. WADE: IF WE CAN GO TO 9158, WHICH IS IN EVIDENCE PER STIPULATION.

1458

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

1460

MR. WADE: AND THIS IS THE ESTRADIOL ELISA ASSAY VALIDATION REPORT ON THE EDISON 3.5 THERANOS SYSTEM; CORRECT?

1462

MR. WADE: AND YOU SIGNED THIS DOCUMENT ON SEPTEMBER 18TH, 2014; CORRECT?

1464

MR. WADE: AND IT WAS SIGNED BY FIVE OF YOUR COLLEAGUES AS WELL; CORRECT?

1466

MR. WADE: MY APOLOGIES, FOUR OF YOUR COLLEAGUES?

1468

MR. WADE: AND YOU SIGNED THIS BECAUSE YOU THOUGHT IT WAS APPROPRIATE TO OFFER THIS WITH PATIENTS IN THE CLIA LAB?

1470

MR. WADE: AND YOU FELT THAT THIS MET ALL OF THE REQUIREMENTS SET FORTH IN FEDERAL LAW; IS THAT RIGHT?

1472

MR. WADE: OKAY. I'D LIKE TO PUT UP BEFORE YOU, DR. ROSENDORFF, A DEMONSTRATIVE THAT HAS BEEN OFFERED TO THE COURT AND I UNDERSTAND THE GOVERNMENT HAS STIPULATED TO?

1473

MR. BOSTIC: CORRECT, YOUR HONOR.

1474

JUDGE DAVILA: THAT CAN BE PUBLISHED NOW.

1475

BY MR. WADE:

1476

MR. WADE: SIR, WHAT I'VE DONE IS TAKEN A CALENDAR AND RUN THE CALENDAR FROM SEPTEMBER OF 2013 TO SEPTEMBER OF 2014. DO YOU SEE THAT?

1478

MR. WADE: AND I HAVE HIGHLIGHTED THE DATE ON WHICH YOU SIGNED ASSAY VALIDATION REPORTS FOR THE EDISON ASSAY. DO YOU SEE THAT?

1480

MR. WADE: AND IF AT ANY POINT WHEN WE TALK ABOUT THIS DEMONSTRATIVE IF YOU WANT TO LOOK BACK AT THOSE VALIDATION REPORTS, YOU JUST LET ME KNOW AND WE'LL GO BACK TO THEM. OKAY?

1482

MR. WADE: AND MY QUESTION FOR YOU AT THIS POINT, SIR, IS -- BEFORE I TURNED TO THE CALENDAR, YOU WOULD NOT HAVE KEPT SIGNING THE VALIDATION REPORTS FOR A 3.5 ASSAY IF YOU THOUGHT THE ASSAY WAS INHERENTLY UNRELIABLE, WOULD YOU?

1483

ADAM ROSENDORFF: I WOULD NOT.

1484

MR. WADE: AND I'D LIKE TO LOOK -- I BELIEVE YOU HAVE A WHITE BINDER STILL IN FRONT OF YOU THAT IS THE GOVERNMENT BINDER.

1485

ADAM ROSENDORFF: THE WITNESS BINDER?

1488

MR. WADE: YEAH. DO YOU STILL HAVE THE GOVERNMENT WITNESS BINDER STILL IN FRONT OF YOU?

1490

MR. WADE: AND I'D LIKE TO DRAW YOUR ATTENTION TO EXHIBIT 1548. IT IS IN EVIDENCE, BUT LET'S NOT PUBLISH IT QUITE YET.

1492

MR. WADE: YEAH. DO YOU SEE 1548?

1494

MR. WADE: AND DO YOU RECALL THIS IS A DOCUMENT THAT YOU WERE SHOWN THAT RELATES TO THAT EXPERIMENT THAT WAS DONE ON PROFICIENCY TESTING MATERIAL WITH -- ON THE EDISON DEVICE? DO YOU RECALL THAT?

1496

MR. WADE: AND THIS DOCUMENT IS DATED FEBRUARY 2ND, 2014; CORRECT?

1497

ADAM ROSENDORFF: FEBRUARY 20TH, 2014.

1498

MR. WADE: I'M SORRY. FEBRUARY -- ANOTHER ONE OF THOSE TRANSCRIPTION ERRORS THAT ARE BETWEEN THE PAGE AND THE HEAD THAT WE TALKED ABOUT EARLIER; RIGHT?

1500

MR. WADE: AND FEBRUARY 20TH, 2014; CORRECT?

1502

MR. WADE: I'M GOING TO PUT THE DOCUMENT UP, BUT I JUST WANT TO LOOK AT IT ON THE CALENDAR HERE. MADAM DEPUTY, CAN I MARK ON THE SCREEN ON THIS?

1503

COURT CLERK: YOU SHOULD BE ABLE TO, COUNSEL.

1504

MR. WADE: I CAN'T, BUT WITH THE COURT'S INDULGENCE.

1505

(PAUSE IN PROCEEDINGS.)

1506

BY MR. WADE:

1507

MR. WADE: SINCE I DON'T HAVE THE ABILITY TO WRITE ON THE SCREEN, LET ME JUST NOTE THAT BASED ON YOUR EDUCATION AND TRAINING, YOU RECOGNIZE THAT FEBRUARY 20TH, 2014 FALLS SOMEWHERE BETWEEN THOSE TWO VALIDATION REPORTS ON THE 14TH AND 15TH AND THE VALIDATION REPORT ON MARCH 19TH? DO YOU SEE THAT?

1509

MR. WADE: IF WE COULD PUBLISH 1548. AND IF WE CAN JUST GO QUICKLY TO THE SPREADSHEET. LET'S LOOK AT THE DATE JUST SO THAT THE JURY CAN SEE THE DATE. THAT'S FEBRUARY 20TH, 2014. DO YOU SEE THAT?

1511

MR. WADE: AND IF WE CAN GO TO THE ATTACHED SPREADSHEET FOR THIS EXHIBIT. DO YOU RECALL BEING SHOWN THIS EXHIBIT?

1513

MR. WADE: AND THIS IS DATA THAT YOU WERE MADE AWARE OF IN CONNECTION WITH THIS EXPERIMENT THAT WAS DONE WITHIN THE LAB ON PRECISION TESTING MATERIAL?

1514

ADAM ROSENDORFF: PROFICIENCY TESTING MATERIAL, YES.

1515

MR. WADE: DO YOU RECALL THAT?

1517

MR. WADE: AND IF WE CAN GO BACK TO THE DEMONSTRATIVE. THERE WAS NOTHING THAT AROSE AS A RESULT OF THE DATA IN THIS DOCUMENT THAT GAVE YOU SUFFICIENT CONCERN TO STOP YOU FROM SIGNING THAT VALIDATION REPORT ON MARCH 19TH; CORRECT?

1519

MR. WADE: WE CAN GO TO THE EXHIBIT IN THE GOVERNMENT'S BINDER 1432.

1520

ADAM ROSENDORFF: CAN YOU JUST REMIND ME WHEN THIS PROFICIENCY TESTING EXERCISE WAS PERFORMED FOR FEBRUARY 20TH? I BELIEVE SO. FEBRUARY 19TH.

1521

MR. WADE: THERE ISN'T A QUESTION PENDING, SIR.

1522

JUDGE DAVILA: WELL, WILL THAT CLARIFY YOUR PREVIOUS ANSWER?

1525

JUDGE DAVILA: WHY DON'T YOU ASK --

1526

BY MR. WADE:

1527

MR. WADE: I'VE NEVER BEEN ASKED A QUESTION ON EXAMINATION, BUT LET'S START IT NOW.

1528

JUDGE DAVILA: YOU HAVEN'T BEEN PRACTICING LONG ENOUGH.

1529

(LAUGHTER.)

1530

JUDGE DAVILA: SIR, DO YOU NEED TO GIVE SOME CLARIFICATION TO YOUR PREVIOUS ANSWER?

1532

JUDGE DAVILA: OKAY. WHAT IS IT YOU WOULD LIKE --

1533

ADAM ROSENDORFF: SO IT APPEARS ON MARCH 19TH I SIGNED A VALIDATION REPORT FOR AN EDISON INSTRUMENT. MY QUESTION IS ABOUT THE TIMING OF THAT RELATIVE TO THE PROFICIENCY TESTING EXERCISE THAT WAS PERFORMED. WAS IT THE SAME DAY OR --

1534

BY MR. WADE:

1535

MR. WADE: WOULD YOU LIKE TO LOOK BACK AT THAT EXHIBIT WE WERE JUST DISCUSSING?

1537

MR. WADE: OR ARE YOU TALKING ABOUT SOME OTHER FACT THAT IS IN YOUR HEAD? SOME OTHER EVENT?

1538

ADAM ROSENDORFF: NO. IT JUST RELATES TO A PREVIOUS QUESTION.

1539

MR. WADE: OKAY. LET'S GO BACK TO THAT DOCUMENT, WHICH WAS -- LET'S SEE IF WE CAN CLARIFY THIS. THIS WAS EXHIBIT 1548.

1541

MR. WADE: DO YOU SEE THAT?

1543

MR. WADE: AND WE'LL TALK ABOUT PROFICIENCY TESTING IN A BIT, BUT DO YOU RECALL THAT THERE WERE, AFTER THIS TIME PERIOD, THERE WERE A SERIES OF EXPERIMENTS THAT WERE DONE ON THE EDISON DEVICE TO TEST THE ACCURACY ON MARCH 14TH? DO YOU RECALL THAT?

1545

MR. WADE: THAT'S NOT WHAT YOU'RE REFERRING TO?

1547

MR. WADE: OKAY. WE'LL TALK ABOUT THAT MORE LATER. THIS PARTICULAR DOCUMENT IS FEBRUARY 20TH, 2014. DO YOU SEE THAT?

1549

MR. WADE: OKAY. DOES THAT REFRESH YOUR RECOLLECTION?

1551

MR. WADE: OKAY. AND IF WE GO BACK TO THE DEMONSTRATIVE. FEBRUARY 20TH IS BEFORE YOU SIGNED THAT NEXT VALIDATION REPORT ON MARCH 19TH; CORRECT?

1553

MR. WADE: OKAY. CAN WE GO TO EXHIBIT 1432. DO YOU SEE THIS IS A DOCUMENT DATED JANUARY 16TH, 2014? DO YOU SEE THAT?

1555

MR. WADE: AND DO YOU RECALL BEING SHOWN THIS BY THE GOVERNMENT?

1557

MR. WADE: AND IF YOU GO TO THE THIRD PAGE -- I'M SORRY, LET'S GO TO THE FIFTH PAGE. I APOLOGIZE AGAIN. LET'S GO TO THE LAST PAGE, 7, AND WE'LL WORK OUR WAY BACK QUICKLY. DO YOU RECALL WHEN YOU LOOKED AT THIS, THIS WAS QUALITY CONTROL DATA RELATING TO THE EDISON DEVICE?

1559

MR. WADE: OKAY. AND DO YOU SEE ACTUALLY ON PAGE 7 -- AND YOU WERE ASKED ABOUT THIS ON DIRECT EXAMINATION; RIGHT?

1561

MR. WADE: OKAY. DO YOU SEE ON PAGE 7 THERE'S A REFERENCE TO HEPATITIS C VIRUS?

1563

MR. WADE: THE HEPATITIS C VIRUS ASSAY WAS NEVER ACTUALLY OFFERED ON THE EDISON DEVICE; CORRECT?

1564

ADAM ROSENDORFF: NO. I BELIEVE WE DID RUN IT FOR A PATIENT. YES, WE DID.

1565

MR. WADE: YOU THINK YOU RAN IT ON ONE PATIENT?

1567

MR. WADE: AND DID YOU VALIDATE IT FOR THAT PURPOSE?

1569

MR. WADE: OKAY. I HAVEN'T SEEN A VALIDATION REPORT FOR THAT, BUT YOU THINK ON ONE OCCASION YOU VALIDATED IT FOR ONE PATIENT?

1571

MR. WADE: APART FROM THAT ONE PATIENT, DO YOU RECALL EVER RUNNING IT?

1573

MR. WADE: OKAY. WHEN YOU VALIDATED IT FOR THAT ONE PATIENT, WERE YOU COMFORTABLE THAT IT WAS SAFE, ACCURATE, AND RELIABLE FOR USE?

1574

ADAM ROSENDORFF: YES. I WAS CALLED ON THE WEEKEND TO QUICKLY GO THROUGH THE VALIDATION.

1575

MR. WADE: WAS THAT SOME SORT OF AN EMERGENCY PROTOCOL?

1577

MR. WADE: AND YOU WERE COMFORTABLE THAT THE ASSAY MET ALL OF THE REQUIREMENTS AT THAT TIME?

1579

MR. WADE: OKAY. GENERALLY THIS DOCUMENT REFERS TO QC DATA FOR VARIOUS EDISON ASSAYS; RIGHT?

1581

MR. WADE: AND, IN FACT, IF WE GO TO PAGE 6 OF THE EXHIBIT, AT THE BOTTOM YOU SEE THE EMAILS AND IT SAYS QC FOR EDISON ASSAYS; RIGHT?

1583

MR. WADE: AND THERE'S A NUMBER OF CHARTS. IF WE GO TO PAGE 5, RIGHT? DO YOU SEE THIS?

1585

MR. WADE: AND THIS WAS THE DATA THAT YOU WERE SHOWN WHICH WAS THIS SNAPSHOT IN TIME RIGHT HERE. DO YOU RECALL THAT?

1587

MR. WADE: AND AS YOU WORK YOUR WAY FORWARD, PAGE 4, THERE'S MORE DATA; RIGHT? AND YOU'RE DOING MORE ANALYSIS?

1589

MR. WADE: AND YOU OFFER -- DO YOU RECALL OFFERING TESTIMONY ABOUT THIS DOCUMENT ON DIRECT EXAMINATION?

1591

MR. WADE: AND THIS BEING A SOURCE OF CONCERN?

1593

MR. WADE: AND IF WE CAN GO BACK TO THE DEMONSTRATIVE. NOW, THE CONCERNS WEREN'T SUFFICIENTLY SIGNIFICANT THAT IT PROMPTED YOU TO STOP OFFERING THE VALIDATION REPORTS; CORRECT?

1595

MR. WADE: AND THE CONCERNS WEREN'T PARTICULARLY SIGNIFICANT THAT YOU PULLED THESE ASSAYS FROM USE WITHIN THE CLIA LAB?

1596

ADAM ROSENDORFF: SO WHEN I SIGNED THE VALIDATION REPORT, I DON'T KNOW WHAT THE QC IS GOING TO LOOK LIKE BECAUSE IT HASN'T BEEN RUN YET.

1597

MR. WADE: NO, I UNDERSTAND THAT. BUT WHAT I'M SAYING IS THAT YOU HAD SOME QC DATA WITH RESPECT TO ASSAYS THAT WERE PREVIOUSLY IN OPERATION; RIGHT?

1598

ADAM ROSENDORFF: OTHER ASSAYS, YES.

1599

MR. WADE: YEAH, ON THAT DEVICE; RIGHT?

1601

MR. WADE: AND THERE WAS NOTHING ABOUT THAT QC DATA THAT GAVE YOU CONCERN THAT PROMPTED YOU TO NOT SIGN THAT ASSAY VALIDATION REPORT ON MARCH 19TH; CORRECT?

1602

ADAM ROSENDORFF: A DIFFERENT ASSAY.

1603

MR. WADE: A DIFFERENT ASSAY; RIGHT?

1605

MR. WADE: AND THERE WAS NOTHING ABOUT THE EDISON DEVICE THAT PROMPTED YOU NOT TO SIGN THAT VALIDATION REPORT; RIGHT?

1607

MR. WADE: OKAY. LET'S GO TO 1772 AND LOOK AT THE HEADER ON THE TOP. BLOW UP THE HEADER. DO YOU SEE THIS IS AN EMAIL FROM JUNE 12TH, 2014?

1609

MR. WADE: AND DO YOU SEE THAT? AND LET'S GO TO THE SECOND PAGE. DO YOU RECALL THAT THIS IS SOME QC DATA THAT YOU WERE SHOWN ON DIRECT EXAMINATION?

1611

MR. WADE: AND DO YOU RECALL TALKING ABOUT CONCERNS RELATING TO THIS?

1613

MR. WADE: COULD WE GO TO THE DEMONSTRATIVE. THERE WAS NOTHING ABOUT THESE CONCERNS OF JUNE OF 2014 THAT PREVENTED YOU FROM SIGNING ASSAY VALIDATION REPORTS FOR THE EDISON IN AUGUST AND SEPTEMBER; CORRECT?

1615

MR. WADE: I'M DONE WITH THIS DEMONSTRATIVE. IS IT FAIR TO SAY, SIR, THAT QUALITY CONTROL FAILURES HAPPEN SOMETIMES WITHIN CLIA LABS; RIGHT?

1617

MR. WADE: AND I BELIEVE YOU MENTIONED TO THE GOVERNMENT IN ONE OF YOUR INTERVIEWS THAT AT UPMC, IN YOUR EXPERIENCE, THERE WAS A PREDICATE DEVICE THAT WAS 10 PERCENT OR LOWER; RIGHT?

1619

MR. WADE: AND I THINK WE'VE ESTABLISHED YOU HAD A WHOLE TEAM WHO WAS SET UP TO REVIEW AND TRACK THIS; RIGHT?

1620

ADAM ROSENDORFF: I'M SORRY. COULD YOU REPEAT THE QUESTION?

1621

MR. WADE: SURE. YOU HAD MR. GEE WHO WAS SIGNED UP AND RESPONSIBLE FOR THIS; RIGHT?

1623

MR. WADE: AND THEN I THINK YOU TESTIFIED THAT THE PEOPLE WHO OPERATED THE MACHINES NEEDED TO KNOW HOW TO PERFORM QC AS WELL AND GET THAT DATA TO MR. GEE; RIGHT?

1625

MR. WADE: AND THEN HE WOULD HAVE TO COMPILE THAT DATA AND PROVIDE IT TO YOU AND OTHERS; RIGHT?

1627

MR. WADE: AND YOU HAD REGULAR MEETINGS WITH MR. GEE TO MONITOR THIS; CORRECT?

1629

MR. WADE: I'D LIKE TO -- I'D LIKE YOU TO LOOK AT EXHIBIT 13809. DO YOU HAVE THAT IN FRONT OF YOU?

1631

MR. WADE: OKAY. I'LL GIVE YOU A MINUTE, DOCTOR.

1632

ADAM ROSENDORFF: 13809. WHAT ARE WE REFERRING TO? ARE WE DONE WITH THE GOVERNMENT BINDER?

1633

MR. WADE: YEAH. MY APOLOGIES. WE'RE BACK TO THE BLACK BINDER, VOLUME 2 IN YOUR LIBRARY.

1635

MR. WADE: CORRECT.

1637

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

1639

MR. WADE: AND THIS IS A QUALITY SYSTEMS PRESENTATION THAT WAS PREPARED BY LANGLY GEE. DO YOU RECALL?

1640

ADAM ROSENDORFF: I'M READING IT NOW. I DON'T RECALL THE PRESENTATION.

1641

MR. WADE: YEAH. YOU WERE CALLED -- YOU HAD REGULAR QUALITY SYSTEMS MEETINGS WITHIN THE LAB FUNCTION?

1642

ADAM ROSENDORFF: I MET WITH LANGLY ONCE A MONTH.

1643

MR. WADE: AND THAT YOU WOULD DIRECT HIM TO PREPARE SUMMARY DATA AND INFORMATION?

1645

MR. WADE: WITH RESPECT TO THAT?

1647

MR. WADE: DO YOU RECALL THAT?

1649

MR. WADE: AND THAT WAS PART OF YOUR ENSURING THAT YOU WERE DISPATCHING YOUR RESPONSIBILITIES AS LAB DIRECTOR; RIGHT?

1651

MR. WADE: AND ONE OF THE WAYS HE DISPATCHED HIS RESPONSIBILITIES WAS TO COMPILE THAT INFORMATION AND TO PROVIDE IT TO YOU AND PRESENT IT TO YOU; RIGHT?

1653

MR. WADE: TAKE A MINUTE AND LOOK AT THIS DOCUMENT. MY QUESTION FOR YOU, THIS IS ONE OF THOSE PRESENTATIONS WHERE HE DID THAT; CORRECT?

1654

ADAM ROSENDORFF: THIS IS A QUALITY SYSTEMS PRESENTATION THAT WAS PRESENTED TO THE CLS GROUP AND PERHAPS OTHERS, AND IT'S DIFFERENT FROM THE MONTHLY QC MEETINGS I HAD WITH LANGLY.

1655

MR. WADE: OKAY. SO THIS IS A BROADLY PRESENTED WITHIN THE COMPANY?

1657

MR. WADE: MOVE TO ADMIT EXHIBIT 13809.

1658

MR. BOSTIC: NO OBJECTION.

1659

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

1660

(DEFENDANT'S EXHIBIT 13809 WAS RECEIVED IN EVIDENCE.)

1661

BY MR. WADE:

1662

MR. WADE: AND GIVE US A SENSE WHO MIGHT BE IN THE ROOM FOR THIS PRESENTATION.

1663

ADAM ROSENDORFF: I DO NOT RECALL.

1664

MR. WADE: AND WERE THESE QUARTERLY MEETINGS?

1665

ADAM ROSENDORFF: WELL, THIS ONE SAYS Q1/Q2. SO IT LOOKS LIKE THERE ARE TWO QUARTERS WRAPPED UP IN THIS REVIEW. THEY'RE SUPPOSED TO BE QUARTERLY.

1666

MR. WADE: AND THAT'S WHAT YOU REQUESTED?

1668

MR. WADE: ACTUALLY, I THINK IT LOOKS KIND OF LIKE Q3 IN THERE BECAUSE YOU WERE IN Q3 BY THIS POINT; RIGHT?

1670

MR. WADE: RIGHT. JULY IS WITHIN THE THIRD QUARTER?

1671

ADAM ROSENDORFF: CORRECT, CORRECT.

1672

MR. WADE: AND IF WE CAN GO TO PAGE 2. THIS IS AN AGENDA. AND WAS THIS A MEETING WHERE MR. GEE WAS PRESENTING?

1674

MR. WADE: AND HE WOULD PRESENT A SLIDE DECK AND WALK PEOPLE THROUGH THIS DATA?

1676

MR. WADE: AND LET'S WALK THROUGH SOME OF THIS. THE THIRD PAGE IS THE MISSION AND CORE STATEMENT. AND DO YOU SEE ON THE BOTTOM THE CORE VALUES THERE?

1678

MR. WADE: AND WAS THIS SOMETHING THAT YOU DIRECTED AS THE LAB DIRECTOR? WAS THIS PART OF YOUR GOALS AND ASPIRATIONS FOR THE ORGANIZATION?

1679

ADAM ROSENDORFF: I SUPPORTED THE STATED VALUE, OR THE STATED GOAL. I DIDN'T WRITE THE STATEMENT.

1680

MR. WADE: OKAY. IF WE CAN GO TO THE NEXT PAGE. IN THIS SLIDE, THIS WALKS THROUGH THE THERANOS LABORATORY LICENSES?

1682

MR. WADE: AND DOES THIS ACCURATELY, TO THE BEST OF YOUR RECOLLECTION, REFLECT THE STATE OF THE LICENSES OF THE CLIA LAB AT THAT TIME?

1683

ADAM ROSENDORFF: I HONESTLY RELIED ON LANGLY TO KEEP TRACK OF THE LICENSES AND I DON'T RECALL THE TIMELINE AS I SIT HERE TODAY.

1684

MR. WADE: AND DO YOU HAVE ANY REASON TO QUESTION THE ACCURACY OF THE INFORMATION THAT WAS PRESENTED?

1686

MR. WADE: OKAY. LET'S GO TO THE NEXT PAGE. THIS, THIS SLIDE SETS FORTH THE SAMPLE COUNTS AND IT COMPARES IT TO WHAT THE FORECAST WAS. DO YOU SEE THAT?

1688

MR. WADE: AND SO ONE OF THE THINGS -- AND WE TALKED ABOUT HOW THERE WAS AN INCREASE IN VOLUME OVER TIME; RIGHT?

1690

MR. WADE: AND ONE OF THE THINGS YOU WERE WORKING TO DO IS SORT OF RAMP UP THE OPERATIONS; RIGHT?

1692

MR. WADE: AND THERE WAS PROJECTED GROWTH?

1694

MR. WADE: AND YOU WERE SORT OF SEEING HOW YOU WERE DOING WITH THE PROJECTED GROWTH?

1696

MR. WADE: AND SO IN Q4 OF 2013, THIS WOULD BE THE SAMPLE VOLUME WAS 254 SAMPLES?

1698

MR. WADE: AND THAT'S MAYBE NOT SURPRISING BECAUSE THE -- I THINK WE SAID THAT THE GENERAL PUBLIC LAUNCH WAS EARLY NOVEMBER. DO YOU RECALL THAT?

1700

MR. WADE: OKAY. AND YOU SEE Q1 IT ACTUALLY GOES UP A LITTLE BIT. IT GOES UP TO 663; IS THAT RIGHT?

1702

MR. WADE: AND THAT'S THE TOTAL SAMPLE VOLUME FOR ALL ASSAYS WITHIN THE CLIA LAB?

1703

ADAM ROSENDORFF: IT LOOKS LIKE THAT. I DON'T THINK THEY'RE BREAKING IT OUT WITH VACUTAINERS AND CTN'S.

1704

MR. WADE: OKAY. LET'S GO ON AND SEE WHAT OTHER DATA WE SEE. THIS IS THE WALGREENS/THERANOS SAMPLES BY STORE. DO YOU SEE THAT?

1706

MR. WADE: AND IF WE LOOK IN THE LEFT-HAND COLUMN, DO YOU SEE THAT IT SAYS THERE WERE 10 SAMPLES IN OCTOBER OF 2013?

1708

MR. WADE: AND THEN IT RAMPS UP A LITTLE BIT IN NOVEMBER; RIGHT?

1710

MR. WADE: AND AT THAT POINT THERE ARE THREE DIFFERENT LOCATIONS IN NOVEMBER. DO YOU SEE THAT?

1712

MR. WADE: AND THEN IT, IT GOES UP A LITTLE BIT MORE IN DECEMBER; RIGHT?

1714

MR. WADE: AND THERE'S A FOURTH LOCATION ADDED, IT LOOKS LIKE, BUT MAYBE ONLY ONE SAMPLE WAS DONE THERE FOR A WHILE. IT LOOKS LIKE MAYBE THAT WAS A SOFT LAUNCH OR SOMETHING.

1715

ADAM ROSENDORFF: 1601 WAS THE ACTUAL THERANOS BUILDING, YEAH.

1716

MR. WADE: AND SO YOU BEGAN TRACKING THE SAMPLES THAT WERE BEING RUN WITHIN THE BUILDING?

1717

ADAM ROSENDORFF: NO, BUT THAT'S ACTUALLY A SAMPLE THAT WAS COLLECTED IN THE BUILDING.

1718

MR. WADE: OH, OKAY. THAT WAS COLLECTED IN THE BUILDING?

1720

MR. WADE: OKAY. AND THEN WE SEE SORT OF THE BREAKOUT THERE BY STORE; RIGHT?

1722

MR. WADE: THE NEXT PAGE SHOWS AVERAGE PATIENT WAITING TIME. DO YOU SEE THAT?

1724

MR. WADE: AND THAT'S IN HOURS I THINK. AND THAT WAS DATA THAT WAS BEING TRACKED BY THE COMPANY AS WELL; RIGHT?

1726

MR. WADE: BECAUSE THAT WOULD AFFECT THE DIFFERENT PROCEDURES YOU MIGHT HAVE TO HAVE IN PLACE DEPENDING ON HOW FREQUENTLY THE CUSTOMERS WERE COMING THROUGH; RIGHT?

1727

ADAM ROSENDORFF: I DON'T UNDERSTAND YOUR COMMENT.

1728

MR. WADE: OKAY. WELL, LET'S SAY THAT IT SPIKED UP TO THAT THEY WERE WAITING FOR OVER AN HOUR OR SOMETHING. YOU MIGHT HAVE TO PUT MORE RESOURCES IN A LOCATION; RIGHT?

1730

MR. WADE: LET'S GO TO A NEXT LINE.

1731

ADAM ROSENDORFF: BUT THOSE KIND OF OPERATIONAL DECISIONS WERE NOT MINE TO MAKE.

1732

MR. WADE: I UNDERSTAND. YOU'RE JUST BEING PRESENTED WITH DATA TO GIVE YOU A PICTURE OF WHAT IS HAPPENING; RIGHT?

1734

MR. WADE: AND, AND YOU SEE THIS SLIDE, WHICH IS BATES LABEL ENDING 515. IT SAYS REDRAWS BY STORE LOCATION. DO YOU SEE THAT?

1736

MR. WADE: AND THE NUMBERS HERE -- THIS IS THE BEST COPY I HAD, SO I APOLOGIZE FOR THE QUALITY OF THE COPY, BUT YOU SEE THE -- YOU CAN SEE ON THE SIDE THAT IT SHOWS HOW MANY THERE ARE, YOU KNOW, IN THAT LEFT-HAND COLUMN?

1738

MR. WADE: AND ACCORDING TO MY COUNT WITH MY MICROSCOPE, I COUNTED ABOUT 26 TOTAL REDRAWS IN THE FIRST QUARTER. DOES THAT SEEM AT LEAST ABOUT RIGHT?

1739

ADAM ROSENDORFF: SO ARE YOU ASKING ME IF THIS DATA IS ACCURATE?

1740

MR. WADE: NO. I'M ASKING YOU IF THAT'S WHAT IT DEPICTS?

1741

ADAM ROSENDORFF: YES, THAT'S WHAT IT DEPICTS.

1742

MR. WADE: IN TERMS OF THE REDRAWS THAT MR. GEE TRACKED AS PART OF HIS QUALITY ASSURANCE PROGRAM?

1743

ADAM ROSENDORFF: YES, THAT'S WHAT THIS DEPICTS.

1744

MR. WADE: OKAY. AND I THINK WE SAW THERE WERE 663 SAMPLES IN QUARTER 1.

1746

MR. WADE: AND IF WE CAN GO TO THE NEXT SLIDE, THIS TRACKS OUT VERY SPECIFICALLY THE REASONS FOR THE REDRAWS. DO YOU SEE THIS?

1748

MR. WADE: AND THIS IS NOW IN JUNE OF 2014; RIGHT?

1750

MR. WADE: AND THE VOLUME WAS GOING UP A LITTLE BIT; CORRECT?

1752

MR. WADE: AND SO ONE OF THE THINGS THAT YOU WANT TO DO AS PART OF YOUR QUALITY ASSURANCE PROGRAM IS THAT YOU WANTED TO TRACK THE REASONS THAT THERE ARE REDRAWS SO YOU CAN MAKE IMPROVEMENTS AND TRY TO AVOID THOSE IN THE FUTURE; RIGHT?

1754

MR. WADE: OKAY. IF WE CAN GO TO THE NEXT ONE. WE'VE TALKED A LITTLE BIT ABOUT TRAINING, AND I THINK YOU'VE EMPHASIZED HOW IMPORTANT IT IS TO HAVE TRAINING; RIGHT?

1756

MR. WADE: AND THIS IS JUST -- THIS DEPICTS THE TRAINING THAT WAS PERFORMED BY VARIOUS PERSONNEL WITHIN THE CLIA LAB; IS THAT RIGHT?

1758

MR. WADE: AND THAT WAS ONE OF MR. GEE'S RESPONSIBILITIES TO TRACK THAT?

1761

ADAM ROSENDORFF: THIS DEPICTS THE TRAINING AS OF Q1 THE WAY I READ THIS.

1763

ADAM ROSENDORFF: THIS SAYS Q1 IN PARENTHESIS, YEAH.

1764

MR. WADE: FAIR POINT. IT SAYS CLIA TRAINING, AND IN PARENTHESIS IT SAYS Q1?

1766

MR. WADE: AND SO IT'S FAIR TO ASSUME IT IS Q1?

1768

MR. WADE: AND IS IT FAIR TO SAY THAT TRAINING WAS ONGOING?

1770

MR. WADE: AND PARTICULARLY AS NEW PERSONNEL CAME IN?

1771

ADAM ROSENDORFF: WELL, IF THERE IS A NEW METHOD BEING IMPLEMENTED IN THE LAB, YOU NEED TO HAVE TRAINING ON THAT METHOD. IF IT WAS NEW PERSONNEL, THEY WERE GOING TO NEED TO BE TRAINED ON ALL OF THE METHODS.

1772

MR. WADE: I UNDERSTAND. AND THAT'S PART OF THE REASON THAT YOU HAVE THE DIFFERENT PROTOCOLS; RIGHT?

1773

ADAM ROSENDORFF: YES, THAT'S TRAINING DOCUMENTS, CORRECT.

1774

MR. WADE: LET'S GO TO THE NEXT PAGE. AND THIS DOCUMENT TALKS ABOUT PROCESS IMPROVEMENTS; RIGHT?

1776

MR. WADE: BECAUSE THERE WERE GOALS TO CONTINUOUSLY IMPROVE; RIGHT?

1778

MR. WADE: AND DO YOU SEE UP TOP THERE IT SAYS THE IMPROVEMENTS TO THE LIS; RIGHT?

1780

MR. WADE: AND THAT'S THE DATABASE SYSTEM THAT TRACKS ALL OF THE IMPORTANT DATA WITHIN THE LAB?

1782

MR. WADE: AND GIVES YOU ALL OF THOSE DETAILS THAT WE WERE TALKING ABOUT BEFORE?

1784

MR. WADE: OKAY. AND IT NOTES INCREASED STAFF BY 12 EMPLOYEES. DO YOU RECALL THAT?

1785

ADAM ROSENDORFF: I DO NOT RECALL THAT WE INCREASED STAFF BY 12 EMPLOYEES IN Q1/Q2.

1786

MR. WADE: WELL, WE HAVE SOME ORG CHARTS A LITTLE LATER IN THE PRESENTATION AND WE'LL GET THROUGH THOSE AS WE WALK THROUGH AND MAYBE IT WILL REFRESH YOUR RECOLLECTION. OKAY?

1788

MR. WADE: AND DO YOU SEE WHERE IT SAYS EDISON LEVEY-JENNINGS CHARTS CREATED BY KARTHIK?

1790

MR. WADE: AND KARTHIK WAS A STATISTICIAN THAT WORKED UNDER DR. YOUNG?

1791

ADAM ROSENDORFF: UM, KARTHIK -- YOU KNOW, KARTHIK WAS A SMART GUY. I DO NOT KNOW HIS JOB DESCRIPTION WITHIN THE COMPANY.

1792

MR. WADE: WAS HE A GUY WHO CRUNCHED A LOT OF NUMBERS?

1793

ADAM ROSENDORFF: I DON'T RECALL.

1794

MR. WADE: OKAY. BUT YOU SEE THERE THERE'S AN INDICATION THAT HE'S THE ONE WHO CREATED LEVEY-JENNINGS CHARTS; RIGHT?

1796

MR. WADE: AND THOSE ARE THE QC CHARTS THAT WE TALKED ABOUT THAT YOU REVIEWED THE WESTGARD RULES UNDER; RIGHT?

1797

ADAM ROSENDORFF: I REVIEWED WITH LANGLY GEE ONCE A MONTH THE AVERAGE FAILURE RATES ON THE EDISON MACHINES THAT WERE IN OPERATION. I WROTE AN SOP INSTRUCTING THE LAB REGARDING WESTGARD RULES AND LEVEY-JENNINGS PLOTS. I DID NOT REVIEW THE -- I DON'T RECALL THAT I REVIEWED THE LEVEY-JENNINGS DATA WITH LANGLY EVERY MONTH.

1798

MR. WADE: OKAY. BUT YOU WOULD HAVE EXPECTED THAT MR. GEE WOULD DO THAT ON A REGULAR BASIS?

1800

MR. WADE: AND YOU WOULD HAVE RELIED UPON HIM FOR THAT?

1802

MR. WADE: AND IF HE HAD AN ISSUE, HE WOULD RAISE IT WITH YOU?

1804

MR. WADE: OKAY. AND DO YOU SEE THERE AT THE END IT SAYS TRANSFERRED FOUR ASSAYS TO NORMANDY. DO YOU SEE THAT?

1806

MR. WADE: AND FOR A TOTAL OF EIGHT AT THIS TIME; RIGHT?

1808

MR. WADE: LET'S GO TO THE NEXT SLIDE. OKAY. AND HERE IS A COMPILATION OF QUALITY CONTROL DATA. DO YOU SEE THAT?

1810

MR. WADE: AND IT'S BROKEN OUT BY SOME DIFFERENT METHODS; RIGHT?

1811

ADAM ROSENDORFF: YES. I SEE PREDICATE AND THERANOS METHODS.

1812

MR. WADE: OKAY. LET'S FOCUS ON THE -- IF WE CAN BLOW UP KIND OF THE LEFT COLUMN. THIS IS TOTAL; RIGHT?

1814

MR. WADE: AND SO THIS IS ALL ENCOMPASSING IF YOU LOOK AT ALL THE TESTS OFFERED AND ALL OF THE CONTROLS ANALYZED, RIGHT, INCLUDING THE PREDICATE METHODS?

1816

MR. WADE: AND THE FAILURE RATE THERE, BASED ON ALL OF THE CONTROLS, IS .14 PERCENT. DO YOU SEE THAT?

1817

ADAM ROSENDORFF: IT LOOKS LIKE THESE ARE ALL OF THE TESTS BEING BUNDLED INTO ONE.

1818

MR. WADE: ALL TESTS?

1820

MR. WADE: AND SO ALL OF THE QUALITY CONTROL TESTS?

1822

MR. WADE: OKAY. LET'S GO BACK OUT. MAYBE WE CAN SET THE TABLE. SO IN THE LEFT COLUMN IT LOOKS LIKE YOU HAVE ALL TESTS, AND THEN IN THE MIDDLE IT'S JUST PREDICATE TESTS; CORRECT?

1824

MR. WADE: AND BY PREDICATE WE MEAN THOSE BIG MACHINES AND VENOUS DRAWS; RIGHT?

1826

MR. WADE: FDA APPROVED MACHINES?

1828

MR. WADE: AND IN THE RIGHT-HAND COLUMN, THAT'S FOCUSSED ON THERANOS; RIGHT?

1830

MR. WADE: AND AT THIS TIME THERE WERE 52 ASSAYS BEING PERFORMED; RIGHT?

1832

MR. WADE: AND THAT WAS A COMBINATION, WE'VE TALKED ABOUT THIS AGAIN, BUT THAT WAS A COMBINATION OF THE EDISON ASSAYS AND THE ASSAYS THAT WERE BEING RUN ON THE, ON THE SIEMENS DEVICE WITH MODIFIED TECHNOLOGY; CORRECT?

1833

ADAM ROSENDORFF: THE QC ON THE SIEMENS DEVICE, IT WAS THE SAME QC FOR BOTH PREDICATE AND THERANOS.

1834

MR. WADE: OKAY. SO SAME QC?

1836

MR. WADE: OKAY. AND THESE NUMBERS, THEY'RE COMBINING THOSE TOGETHER; CORRECT?

1838

MR. WADE: AND THE TOTAL FAILURE THERE FOR ALL OF THOSE COMBINED IS 2.9 PERCENT; RIGHT?

1840

MR. WADE: OKAY. AND IF, IF WE LOOK UP AT THE TOP -- I'M SORRY, IN THE MIDDLE, DO YOU SEE THE Q1 PREDICATE?

1842

MR. WADE: AND THAT SAYS 132 ASSAYS PERFORMED?

1844

MR. WADE: AND 8458 CONTROLS ANALYZED?

1845

ADAM ROSENDORFF: THAT'S A LOT OF CONTROLS GIVEN THERE ARE ONLY 132 ASSAYS RUN. THAT'S A LOT OF CONTROLS. I DON'T KNOW WHY SO MANY CONTROLS WERE RUN.

1846

MR. WADE: IT WAS MR. GEE'S DATA; RIGHT?

1848

MR. WADE: AND IT HAS A FAILURE RATE OF .75 PERCENT. DO YOU SEE THAT?

1849

ADAM ROSENDORFF: I'M READING THAT.

1850

MR. WADE: AND IF YOU GO TO THE NEXT SLIDE -- AND THIS ONE IS A LITTLE HARD TO MAKE OUT WITH THE QUALITY OF THE COPY -- BUT THIS BREAKS OUT THE ELISA FAILED QUALITY CONTROL. DO YOU SEE THAT?

1852

MR. WADE: AND THESE WOULD HAVE BEEN THE EDISON ASSAYS.

1854

MR. WADE: AND WHAT HE'S DOING HERE IS HE'S COMPILING ALL OF THE FAILURES THAT HAPPEN ON AN ASSAY-BY-ASSAY BASIS OVER TIME; CORRECT?

1856

MR. WADE: IN Q1. ON THIS SLIDE IT'S FOR Q1; CORRECT?

1858

MR. WADE: AND IT'S SEVEN ASSAYS AT THIS TIME?

1860

MR. WADE: OKAY. SO IT HAS THE TOTAL IN THE BAR GRAPH AND THEN IT HAS UP AT THE TOP, IT'S HARD TO SEE IN THE COLOR, BUT IT'S -- WELL, YOU CAN ACTUALLY SEE IT A LITTLE BETTER ON THE SCREEN -- FAILED HIGH AND FAILED LOW. DO YOU SEE THAT?

1862

MR. WADE: AND THIS WOULD HAVE BEEN THE COMPILED DATA. WE TALKED ABOUT HOW WE WOULD COMPILE SOME DATA OVER TIME?

1864

MR. WADE: AND YOU WOULD LOOK AT IT. THIS WAS THE COMPILED DATA?

1865

ADAM ROSENDORFF: THIS IS NOT THE DATA THAT LANGLY WOULD BE PRESENTING TO ME DURING OUR MONTHLY MEETINGS.

1866

MR. WADE: OKAY. YOU WOULD HAVE OTHER DATA FOR THAT?

1868

MR. WADE: AND WOULD THAT MAYBE INCLUDE SOMETIMES LEVEY-JENNINGS CHARTS, TOO?

1870

MR. WADE: AND JUST MAYBE MORE SUMMARY DATA?

1871

ADAM ROSENDORFF: IT WOULD BE THE ASSAYS AND THE PERCENT FAILURE RATES FOR THE ASSAYS.

1873

ADAM ROSENDORFF: THAT WAS BASICALLY IT. THAT'S WHAT I RECALL AT LEAST.

1874

MR. WADE: AND SO THE MATH WOULD BE PERFORMED ESSENTIALLY. YOU WOULD HAVE --

1876

MR. WADE: IT WOULDN'T BE DEPICTED THIS WAY?

1877

ADAM ROSENDORFF: NO, IT WOULD NOT.

1878

MR. WADE: BUT FOR THIS PARTICULAR PRESENTATION, HE DEPICTS IT THIS WAY SO YOU CAN SEE IT?

1880

MR. WADE: AND THERE WAS NOTHING ABOUT THIS DATA PRESENTATION THAT PROMPTED YOU TO TAKE DOWN ANY OF THE EDISON ELISA ASSAYS?

1882

MR. WADE: OKAY. LET'S GO TO THE NEXT PAGE. HERE'S A -- THIS IS Q3 EDISON QUALITY CONTROL; RIGHT?

1883

ADAM ROSENDORFF: SOMETHING IS NOT SQUARING OUT BECAUSE WHEN I LOOK AT THE PERCENT CONTROL FAILURES IN THE TABLE THAT I REVIEWED WITH THE GOVERNMENT AND I LOOK AT THESE BAR GRAPHS, THEY APPEAR TO BE SHOWING -- THEY'RE VERY DIFFERENT. THE PERCENTAGE GIVES YOU FAILURE RATES THAT APPEAR TO BE MUCH LOWER IN THESE BAR CHARTS THAN IN THE TABLE THAT I REVIEWED WITH THE GOVERNMENT YESTERDAY.

1884

MR. WADE: WELL, AS WITH ANY DATA, IT MAY DEPEND UPON THE POINT AT WHICH YOU LOOK AT THE DATA; RIGHT? IS THAT FAIR WITH DATA?

1885

ADAM ROSENDORFF: YES, I JUST REVIEWED ONE MONTH.

1886

MR. WADE: AND SO WHEN YOU'RE -- DO YOU RECALL WHEN WE WERE LOOKING AT THE VALIDATION REPORT, WE WERE LOOKING AT THE RESULTS AND THERE WAS ONE THAT WAS HIGH, AND THERE WAS ONE THAT WAS LOW, AND THERE WERE ONES THAT WERE KIND OF IN BETWEEN THE AVERAGE AMOUNT, AND THAT'S WHAT IT GETS TO; RIGHT?

1888

MR. WADE: AND AT DIFFERENT POINTS IN TIME THERE COULD BE DIFFERENT FAILURE RATES; RIGHT?

1890

MR. WADE: AND THAT WOULD BE FOR A VARIETY OF REASONS. FOR EXAMPLE, THIS IS IN Q3; RIGHT?

1892

MR. WADE: AND AT THAT POINT THE LAB HAD BEEN UP AND RUNNING FOR A WHILE; RIGHT?

1894

MR. WADE: AND MAYBE PEOPLE WERE TRAINED BETTER; RIGHT?

1895

ADAM ROSENDORFF: IT'S POSSIBLE.

1896

MR. WADE: MAYBE THERE WERE SOME ISSUES WITH REAGENTS, THOSE HAVE BEEN IRONED OUT; RIGHT?

1898

MR. WADE: BECAUSE YOU WERE ALWAYS TRYING TO CONTINUOUSLY IMPROVE; RIGHT?

1900

MR. WADE: AND SO IT'S POSSIBLE THAT -- WOULDN'T YOU EXPECT, AS THE LAB MATURED, THAT THE Q3 -- THAT THE FAILURE RATE WOULD GET BETTER OR --

1901

ADAM ROSENDORFF: WELL, FROM MY MEETINGS WITH LANGLY, IT APPEARED THAT THE QC FAILURE RATES REMAINED HIGH OVER A PERIOD OF MANY MONTHS.

1903

ADAM ROSENDORFF: AND THAT'S WHY THIS DATA IS SURPRISING TO ME.

1904

MR. WADE: AND HE'S THE ONE WHO IS PRESENTING THE DATA; CORRECT?

1906

MR. WADE: AND HE'S THE ONE WHO IS RESPONSIBLE FOR THE DATA; CORRECT?

1908

MR. WADE: AND LET'S GO TO THE NEXT SLIDE. AND YOU SEE, YOU SEE THE OCCURRENCE HERE. JUST A MINUTE AGO WE WERE ACTUALLY TALKING ABOUT PREANALYTIC, ANALYTIC, AND POST-ANALYTIC; RIGHT?

1910

MR. WADE: AND HERE YOU'RE TRACKING THE DIFFERENT KINDS OF ERRORS IN THAT WAY; RIGHT?

1912

MR. WADE: AND THIS IS FOR QUARTER 1?

1914

MR. WADE: AND THERE WERE 660 TESTS, DO YOU RECALL, IN QUARTER 1? I THINK IT WAS ONE OF THE FIRST COUPLE OF SLIDES.

1916

MR. WADE: YES. AND HERE THERE ARE IT LOOKS LIKE MAYBE ABOUT 11 ISSUES?

1918

MR. WADE: AND LET'S GO TO THE NEXT PAGE. THESE OCCURRENCES ARE QUARTER 2 AND QUARTER 3. DO YOU SEE THAT?

1920

MR. WADE: AND HERE AGAIN THEY'RE TRACKING PRE-ANALYTIC, ANALYTIC, AND POST-ANALYTIC FOR EACH QUARTER; RIGHT?

1922

MR. WADE: AND IT LOOKS LIKE IT'S UNDER --

1923

ADAM ROSENDORFF: IT'S FOR Q3. WHAT I SEE IS Q2 AND Q3, AND WHAT I SEE IS PREANALYTIC, ANALYTIC, AND POST-ANALYTIC FOR THOSE THREE QUARTERS. ARE YOU WITH ME?

1924

MR. WADE: I AM WITH YOU.

1926

MR. WADE: AND WE DON'T HAVE SAMPLE VOLUME IN THIS DECK FOR THAT, BUT YOU RECALL GENERALLY THAT THE SAMPLE VOLUME IN QUARTER 2 AND QUARTER 3 WAS GOING UP?

1928

MR. WADE: OKAY. LET'S GO TO THE NEXT SLIDE. AND THEY EVEN BREAK OUT -- MR. GEE BREAKS OUT HERE SOME OF THE DIFFERENT TYPES OF OCCURRENCES; RIGHT?

1929

ADAM ROSENDORFF: FOR Q2, CORRECT.

1930

MR. WADE: AND THIS ONE IS FOR Q2?

1932

MR. WADE: AND DO YOU SEE HERE FOR Q2 ACTUALLY, DO YOU SEE THERE ARE BACK ORDERS ON HCG?

1934

MR. WADE: AND WE TALKED ABOUT THAT YESTERDAY; RIGHT? THAT WAS ONE OF THOSE OCCURRENCES; RIGHT?

1935

ADAM ROSENDORFF: WE DISCUSSED BACK ORDERS FOR HCG?

1936

MR. WADE: WELL, WE DISCUSSED -- WE CAN DISCUSS IT WHEN WE NEXT GET TOGETHER, OKAY? DO YOU RECALL DISCUSSING HCG?

1937

ADAM ROSENDORFF: WITH YOU, YEAH.

1938

MR. WADE: OKAY. AND YOU SEE THE ISSUE OF THE EDISON HCG IS IDENTIFIED THERE?

1940

MR. WADE: AS IT SHOULD BE; RIGHT? THAT WAS AN OCCURRENCE THAT HAPPENED AND IT'S TRACKED?

1942

MR. WADE: OKAY. LET'S GO -- I THINK THERE ARE LESS THAN 15 TOTAL IDENTIFIED HERE; RIGHT?

1944

MR. WADE: TWELVE. AND ONE RELATES TO THE EDISON DEVICE?

1946

MR. WADE: LET'S GO TO THE NEXT PAGE. THIS SETS FORTH THE SPECIFICITY THERE WITH RESPECT TO THE DIFFERENT THINGS. AND YOU SEE THERE ARE SOME ISSUES IDENTIFIED WITH A COUPLE OF THE ASSAYS ON THE EDISON DEVICE THAT HAVE COME ONLINE?

1948

MR. WADE: AND THAT'S TRACKED AND THAT'S ADDRESSED; RIGHT?

1949

ADAM ROSENDORFF: SO THERE'S MENTION OF ISSUES IN Q3 FOR ANALYTIC FOR EDISON SHBG, VITAMIN B12, ESTRADIOL, PROLACTIN. IDEALLY WHAT SHOULD HAPPEN IS THAT YOU HAVE A WHAT IS CALLED QUALITY EXCEPTION REPORT THAT DESCRIBES THE DATE OF THE INCIDENT, THE OPERATORS INVOLVED, WHAT EXACTLY OCCURRED, IF IT HAD AN IMPACT ON THE PATIENT RESULTS, AND THEN YOU DO A ROOT CAUSE ANALYSIS, AND THEN YOU COME UP WITH CORRECTIVE AND PREVENTATIVE ACTIONS.

1950

MR. WADE: RIGHT. THAT'S PART OF YOUR QUALITY SYSTEMS MANUAL THAT WE LOOKED AT EARLIER?

1951

ADAM ROSENDORFF: I THINK SO, YES.

1952

MR. WADE: AND THAT'S PART OF A STANDARD QUALITY PROTOCOL THAT YOU WERE INVOLVED IN OVERSEEING WITHIN THE CLIA LAB; RIGHT?

1954

MR. WADE: AND THAT WOULD HAVE BEEN MR. GEE'S RESPONSIBILITY?

1956

MR. WADE: AND DO YOU KNOW WHETHER HE DID IT? DO YOU RECALL?

1957

ADAM ROSENDORFF: I RECALL VERY POOR INCIDENT MANAGEMENT REPORTING AT THERANOS.

1958

MR. WADE: WELL, HE HAS THESE ITEMS LISTED HERE. DO YOU KNOW WHETHER HE WROTE REPORTS ON THOSE?

1959

ADAM ROSENDORFF: NO, HE DID NOT. I DO NOT RECALL.

1960

MR. WADE: YOU DON'T RECALL?

1962

MR. WADE: OKAY. OKAY. WELL, LET'S GO TO THE NEXT PAGE, AND THIS ONE MENTIONS COMPLAINTS. DO YOU SEE THAT?

1964

MR. WADE: AND THESE ARE PHYSICIAN COMPLAINTS OR PATIENT COMPLAINTS; RIGHT? BOTH?

1965

ADAM ROSENDORFF: IT'S DIFFICULT TO SEE WITH THE DIFFERENT SHADING WHAT IS WHAT.

1966

MR. WADE: YEAH. I THINK IF YOU LOOK ON THE BOTTOM YOU SEE THERE ARE TWO DIFFERENT COLORS FOR EACH OF THE COMPLAINTS. ONE IS FOR PATIENT AND ONE IS FOR PHYSICIAN. DO YOU SEE THAT?

1968

MR. WADE: AND THEY IDENTIFY TWO FOR EACH?

1970

MR. WADE: AND THAT'S FOR THE 660-SOMETHING TEST VOLUME?

1972

MR. WADE: AND LET'S GO TO THE NEXT PAGE. THIS IS QUARTER 3, AND THIS COMBINES -- THIS SHOWS 10 COMPLAINTS IN QUARTER 3?

1974

MR. WADE: DO YOU SEE THAT?

1976

MR. WADE: AND I THINK WE DON'T KNOW WHAT THE VOLUME WAS, BUT I THINK YOU TESTIFIED IT WAS GOING UP?

1978

MR. WADE: AND IF YOU GO TO THE NEXT PAGE, THOSE COMPLAINTS, RIGHT, IT SPECIFIES THE COMPLAINTS THAT WERE RECEIVED?

1980

MR. WADE: AND IT'S FAIR TO SAY THERE'S KIND OF A BASKET OF DIFFERENT ITEMS THAT COME UP WITH RESPECT TO COMPLAINTS; RIGHT?

1982

MR. WADE: LIKE, FOR EXAMPLE, THE FIRST ONE IN Q3 SAYS, NO ONE ANSWERED PHONE ON SUNDAY AND COULD NOT LEAVE A VOICEMAIL; RIGHT?

1984

MR. WADE: AND SOME OF -- ONE OF THEM DOWN THERE, THERE IS ONE THAT SAYS TESTOSTERONE RESULT WAS WRONG; RIGHT?

1986

MR. WADE: AND THAT'S TRACKED SO THAT YOU CAN IMPROVE IT; CORRECT?

1987

ADAM ROSENDORFF: YES. WELL, THERE'S NO DESCRIPTION OF THE EVENTS. I DON'T RECALL THAT EVENT HAVING BEEN WRITTEN UP AS A QUALITY EXCEPTION, SO IT'S REALLY DIFFICULT TO -- YOU KNOW, ABSENT THOSE THINGS, IT'S REALLY DIFFICULT TO CORRECT THAT ISSUE.

1988

MR. WADE: OKAY. I UNDERSTAND. LET'S GO TO -- WELL, I BELIEVE YOU SAID THAT THIS ISN'T THE DOCUMENTATION OF THOSE ITEMS; RIGHT? THAT WOULD BE -- THIS IS A PRESENTATION THAT --

1989

ADAM ROSENDORFF: RIGHT, IT'S A SUMMARY. IT'S A SUMMARY. YEAH.

1990

MR. WADE: AND THAT INFORMATION WOULD BE DOCUMENTED IN OTHER DOCUMENTS IN THE LAB BY MR. GEE; CORRECT?

1991

ADAM ROSENDORFF: IT SHOULD HAVE BEEN.

1992

MR. WADE: IT SHOULD HAVE BEEN. OKAY. LET'S GO TO -- LET'S JUMP A COUPLE SLIDES FORWARD TO BATES RANGE ENDING IN 531. DO YOU SEE THIS IS PROFICIENCY TESTING?

1994

MR. WADE: AND THIS IS FOR QUARTER 1 AND QUARTER 2?

1996

MR. WADE: AND THIS IS FOR THE PREDICATE DEVICES; CORRECT?

1997

ADAM ROSENDORFF: WELL, SINCE THERE IS NO PROFICIENCY TESTING CONDUCTED ON THE THERANOS DEVICES, YES, IT WAS ON THE PREDICATE DEVICES.

1998

MR. WADE: WHY DON'T WE COME BACK TO THE PROFICIENCY TESTING ITEM?

2000

MR. WADE: BUT YOU SEE THAT THERE IS PROFICIENCY TESTING REFERENCED HERE; CORRECT?

2002

MR. WADE: AND THAT IS IN QUARTER 1 AND QUARTER 2?

2004

MR. WADE: OKAY. LET'S, LET'S JUMP TO BATES ENDING 534. DO YOU SEE THIS IS AN ORG CHART AT THE END OF 3-31-2014?

2006

MR. WADE: AND DO YOU SEE THAT? AND THIS IDENTIFIED THE TEAM OF PEOPLE WHO ARE WORKING WITH YOU IN THE LAB; RIGHT?

2008

MR. WADE: AND I WON'T COUNT THEM HERE. WE HAVE THEM IN EVIDENCE. BUT I JUST NOTE THAT THE NEXT SLIDE IS GOING TO SHOW THAT ORG CHART AS OF 6-30-2014, AND I THINK WHEN YOU LOOK AT THE BOTTOM YOU'LL SEE SOME ADDITIONAL PEOPLE.

2010

MR. WADE: AND YOU'LL RECALL THAT THERE WAS SOME STAFFING UP THAT NEEDED TO BE DONE IF THE VOLUME WAS GOING UP?

2012

MR. WADE: AND THAT WAS DONE UNDER YOUR DIRECTION?

2013

ADAM ROSENDORFF: THAT WOULD BE SUNNY DETERMINING BASED ON THE SAMPLE VOLUMES.

2014

MR. WADE: AND HE WAS -- HE HAD THE MANAGEMENT SUPERVISION OF THE LAB AND HE WOULD AUTHORIZE YOU TO HIRE SOMEONE NEW?

2016

MR. WADE: AND THEN YOU WOULD GO THROUGH THAT PROCESS THAT YOU PREVIOUSLY TESTIFIED ABOUT?

2018

MR. WADE: OKAY. AND IF WE GO TO THE 6-30-2014 SLIDE. I'M SORRY. GO TO THE NEXT SLIDE, WHICH IS ALSO DATED 6-30-2014. THIS IDENTIFIED EVEN THE PHLEBOTOMISTS WHO ARE OUT IN THE FIELD WORKING FOR THERANOS TAKING SAMPLES; RIGHT?

2019

ADAM ROSENDORFF: CORRECT. I -- IT APPEARS THAT THIS CHART IS SPECIFIC TO THE PHLEBOTOMIST.

2022

MR. WADE: IS IT FAIR TO SAY THAT YOU DIDN'T SPEND A LOT OF TIME DIRECTLY SUPERVISING THE PHLEBOTOMISTS?

2023

ADAM ROSENDORFF: I DID NOT SUPERVISE THE PHLEBOTOMISTS, YEAH.

2024

MR. WADE: OKAY. SO THEY HAVE IT FLOWING FROM YOU, BUT THEY WERE KIND OF SEPARATE TEAMS?

2026

MR. WADE: AND I BELIEVE THE NEXT SLIDE --

2027

ADAM ROSENDORFF: I MEAN, THEY WERE ALL IN -- MOST OF THEM WERE IN ARIZONA. I WAS IN CALIFORNIA, SO --

2028

MR. WADE: UNDERSTOOD. AND IF I COULD JUST LASTLY BRING YOUR ATTENTION TO BATES RANGE ENDING IN 542. HERE HE IS TRACKING AMENDED AND CORRECTED REPORTS?

2030

MR. WADE: AND HE NOTES TWO IN Q4?

2032

MR. WADE: AND NONE IN QUARTER 1?

2034

MR. WADE: AND THAT WAS -- THAT WOULD HAVE BEEN -- THE TEST REPORTING WAS PART OF -- I THINK YESTERDAY WE LOOKED AT THE PROCEDURE FOR TEST REPORTING?

2036

MR. WADE: OKAY. I DON'T HAVE ANYTHING FURTHER ON THAT DOCUMENT. YOU MENTIONED A COUPLE OF TIMES PRECISION TESTING. DO YOU RECALL THAT?

2038

MR. WADE: AND I WANT TO COME BACK TO THAT A LITTLE BIT. PRECISION TESTING IS SOMETHING THAT WOULD HAVE FALLEN UNDER THE LDT'S RESPONSIBILITIES ULTIMATELY; CORRECT?

2040

MR. WADE: AND MR. GEE WORKED ON THAT AS WELL?

2041

ADAM ROSENDORFF: NO. MR. GEE WORKED ON QUALITY CONTROL AND QUALITY ASSURANCE. PRECISION IS PERFORMED AS PART OF THE INITIAL VALIDATION OF A TEST THAT IS REPEAT MEASUREMENTS ON A SINGLE SAMPLE WITHIN DAYS AND BETWEEN DAYS.

2042

MR. WADE: AND I MAY HAVE USED -- OR I MAY HAVE MISSPOKEN A MINUTE AGO. I WAS SHIFTING TO PROFICIENCY TESTING --

2044

MR. WADE: -- AS OPPOSED TO PRECISION TESTING.

2046

MR. WADE: OKAY. PROFICIENCY TESTING, DO YOU RECALL YOU TESTIFIED ABOUT THAT ON DIRECT EXAMINATION?

2048

MR. WADE: AND THAT'S COME UP A COUPLE OF TIMES DURING THE COURSE OF YOUR TESTIMONY UNDER MY EXAMINATION?

2050

MR. WADE: AND PROFICIENCY TESTING ULTIMATELY IS THE RESPONSIBILITY OF THE LAB DIRECTOR; CORRECT?

2051

ADAM ROSENDORFF: ULTIMATELY, YES.

2052

MR. WADE: BUT THAT IS A RESPONSIBILITY THAT MR. GEE WORKED ON; CORRECT?

2053

ADAM ROSENDORFF: NO. I BELIEVE HODA ALAMDAR, THE TECHNICAL SUPERVISOR, WAS HANDLING PROFICIENCY.

2054

MR. WADE: AND SHE -- HODA WAS -- WAS SHE KIND OF THE NUMBER 2 WITHIN THE LAB? IS THAT FAIR?

2055

ADAM ROSENDORFF: WELL, FOR A PERIOD DR. PANDORI WOULD HAVE BEEN THE CO-LAB DIRECTOR AND HE WOULD HAVE BEEN NUMBER 2 IN THE LAB.

2057

ADAM ROSENDORFF: AND THEN WE HAD GODFREY MASINDE, HE WAS A G.S., GENERAL SUPERVISOR, AND THEN HODA WAS THE TECHNICAL SUPERVISOR.

2058

MR. WADE: AND THEY, THEY -- WHO WAS IT THAT WORKED ON PROFICIENCY TESTING?

2060

MR. WADE: HODA. ON DIRECT EXAMINATION THE GOVERNMENT ASKED YOU ABOUT THAT, AND THEY ASKED IF THERE WAS EVER PROFICIENCY TESTING AT THERANOS, AND YOU TESTIFIED THAT THERE WERE NO FORMAL PROFICIENCY TESTING PROCESSES. DO YOU RECALL THAT?

2061

ADAM ROSENDORFF: THERE WAS NO FORMAL PROFICIENCY TESTING PROCESSES THAT WERE IMPLEMENTED FOR THE THERANOS TESTS.

2062

MR. WADE: BUT THAT'S NOT WHAT YOU TESTIFIED TO. DO YOU RECALL, SIR, THAT YOU WERE ASKED, "AND WAS THERE A PROFICIENCY TESTING PROCESS IN PLACE AT THERANOS WHEN YOU WERE AT THE COMPANY?" AND YOU ANSWERED, "NO, THERE WAS NO FORMAL PROFICIENCY TESTING PROCESS." DO YOU RECALL THAT?

2064

MR. WADE: AND WAS THAT TESTIMONY ACCURATE?

2065

ADAM ROSENDORFF: WELL, THE GOVERNMENT DIDN'T SPECIFY WHETHER THEY WERE TALKING ABOUT THE THERANOS TESTS OR THE PREDICATE TESTS.

2066

MR. WADE: AND YOU DIDN'T SPECIFY IN YOUR ANSWER EITHER, DID YOU?

2068

MR. WADE: SO THAT -- SO LET ME ASK THE QUESTION AGAIN. OKAY? AND JUST SO WE'RE CLEAR, AT THE VERY END OF YOUR TESTIMONY, DO YOU RECALL THAT MR. BOSTIC CAME BACK TO ASK A COUPLE OF FOLLOW-UP QUESTIONS?

2070

MR. WADE: AND WHEN HE CAME BACK, YOU WERE ASKED, PRIOR TO SEPTEMBER OF 2013 BEFORE THE COMMERCIAL LAUNCH, ARE YOU AWARE OF ANY PROFICIENCY TESTING HAPPENING AT THERANOS? AND YOU SAID NO. ARE EITHER OF THOSE --

2071

ADAM ROSENDORFF: SO THAT'S NOT CORRECT. THERE WAS PROFICIENCY TESTING FOR THE PREDICATE METHODS.

2072

MR. WADE: OKAY. BOTH OF THOSE QUESTIONS WERE INACCURATE; CORRECT? BOTH OF THOSE ANSWERS WERE INACCURATE?

2073

ADAM ROSENDORFF: ABOUT WHETHER THERE WAS PROFICIENCY TESTING IN PLACE?

2075

ADAM ROSENDORFF: THERE WAS PROFICIENCY TESTING FOR THE PREDICATE INSTRUMENTS.

2076

MR. WADE: AND SO YOUR QUESTIONS WERE INACCURATE?

2078

MR. WADE: OKAY. SO LET'S WORK TO CLARIFY THIS.

2080

MR. WADE: BECAUSE THERE WAS, SO THE RECORD IS PERFECTLY CLEAR, A PROFICIENCY TESTING PROGRAM IN PLACE FOR TESTS THAT THERANOS WAS RUNNING IN THE CLIA LAB ON COMMERCIAL DEVICES?

2081

ADAM ROSENDORFF: CORRECT. I KNOW THAT PROFICIENCY TESTING WAS BEING RUN ON THE PREDICATE INSTRUMENTS AND BEING REPORTED. I DO NOT SPECIFICALLY RECALL AN SOP RELATING TO PROFICIENCY TESTING. WE MAY HAVE REVIEWED THAT DOCUMENT OR IT MAY HAVE BEEN PART OF THE QUALITY SYSTEMS MANUAL THAT WE REVIEWED.

2082

MR. WADE: WELL, IF THERE WASN'T A PROFICIENCY TESTING PROGRAM, THAT WOULD BE A PROBLEM; RIGHT?

2083

ADAM ROSENDORFF: A POLICY, AN SOP, YES, THAT WOULD BE A PROBLEM.

2084

MR. WADE: DO YOU RECALL THAT BEING THE CASE?

2085

ADAM ROSENDORFF: I DO NOT RECALL.

2087

ADAM ROSENDORFF: THAT MAY BE PART OF THE MISUNDERSTANDING, YOU KNOW, IN THE GOVERNMENT'S QUESTION IN TERMS OF A FORMAL PROCEDURE BEING IN PLACE. I CAN TESTIFY THAT WE WERE RUNNING PROFICIENCY SAMPLES ON THE PREDICATE METHOD, YES. DOES THAT CLEAR IT UP OR --

2088

MR. WADE: WELL, LET'S KEEP GOING AND SEE IF WE CAN CLEAR IT UP SOME MORE.

2090

MR. WADE: DO YOU RECALL YESTERDAY THAT WE TALKED ABOUT SOME OF YOUR INTERVIEWS WITH THE GOVERNMENT; RIGHT?

2092

MR. WADE: AND I THINK YOUR FIRST INTERVIEW WAS IN JULY OF 2016. DO YOU RECALL THAT?

2093

ADAM ROSENDORFF: I RECALL MY FIRST INTERVIEW WITH THE GOVERNMENT WAS WITH THE S.E.C. I DO NOT RECALL THE DATE.

2094

MR. WADE: AND IN ADDITION TO THE S.E.C., MR. LEACH WAS PRESENT. DO YOU RECALL THAT?

2096

MR. WADE: AND THERE WERE A COUPLE OF FBI AGENTS PRESENT?

2098

MR. WADE: IT LOOKED LIKE THERE WAS A WHOLE ROOM FULL OF PEOPLE; RIGHT?

2099

ADAM ROSENDORFF: YES, THERE WERE MANY PEOPLE THERE.

2100

MR. WADE: AND YOU WERE ASKED ABOUT THERANOS PROFICIENCY TESTING. DO YOU RECALL?

2101

ADAM ROSENDORFF: I DO NOT RECALL THAT.

2102

MR. WADE: AND DO YOU RECALL TELLING THE GOVERNMENT IN THAT MEETING THAT EDISON MACHINES DID PRODUCE GOOD RESULTS FROM THE AAP?

2103

ADAM ROSENDORFF: I DO NOT RECALL THAT, NO.

2104

MR. WADE: AND DO YOU RECALL TELLING THEM THAT THERANOS PROPRIETARY MACHINES USED A PROCESS CALLED ALTERNATIVE EFFICIENCY -- ALTERNATIVE ASSESSMENT PROFICIENCY?

2105

ADAM ROSENDORFF: I DO NOT RECALL.

2106

MR. WADE: AND AAP MEASURES ACCURACY; RIGHT?

2108

MR. WADE: OKAY. AND THE AAP WAS THE POLICY THAT WAS SET FORTH TO BE USED ON THE THERANOS DEVICES; CORRECT?

2110

MR. WADE: WHY DON'T YOU TURN IN YOUR YELLOW BINDER TO STATEMENT 11003. DO YOU SEE THAT IN FRONT OF YOU? IT'S A DOCUMENT DATED JULY 22ND, 2016?

2112

MR. WADE: OKAY. I'D LIKE TO CALL YOUR ATTENTION TO THE LAST PARAGRAPH AT THE BOTTOM OF THE THIRD PAGE.

2114

MR. WADE: AND I'D LIKE YOU TO JUST READ THAT TO YOURSELF AND LET ME KNOW WHEN YOU'RE DONE?

2115

(PAUSE IN PROCEEDINGS.)

2116

ADAM ROSENDORFF: YES, I READ IT.

2117

BY MR. WADE:

2118

MR. WADE: AND, SIR, DOES IT REFRESH YOUR RECOLLECTION THAT YOU TOLD THE GOVERNMENT THAT THE EDISON MACHINES DID PRODUCE GOOD RESULTS FROM THE AAP?

2119

ADAM ROSENDORFF: THERE WAS A PROCESS CALLED IQP THAT WAS IMPLEMENTED IN A HAPHAZARD FASHION THAT SEEMED TO PRODUCE GOOD RESULTS. THERE WAS NO FORMAL AAP PROCEDURE THAT DESCRIBED THE STEPS TO BE DONE AND THE ACCEPTANCE CRITERIA THAT WAS SIGNED OFF BY ME IN A DOCUMENT CONTROL SYSTEM.

2120

MR. WADE: OKAY. LET ME, LET ME JUST -- THANK YOU FOR YOUR EXPLANATION. LET ME TRY THE QUESTION ONE MORE TIME. DOES READING THAT PARAGRAPH REFRESH YOUR RECOLLECTION THAT YOU TOLD THE GOVERNMENT THAT EDISON MACHINES DID PRODUCE GOOD RESULTS FROM THE AAP?

2121

ADAM ROSENDORFF: I DON'T RECALL HAVING MADE THAT STATEMENT TO THE GOVERNMENT. I AM ASSUMING THE RECORD IS CORRECT.

2122

MR. WADE: IF I CAN TURN YOU AWAY FROM THE YELLOW BINDER, WE'RE GOING TO GO BACK TO THE BLACK BINDER.

2123

JUDGE DAVILA: WHILE YOU GET THAT, FOLKS, WOULD YOU STAND UP FOR 30 SECONDS IF YOU WOULD LIKE TO STRETCH YOUR LEGS FOR JUST A MOMENT.

2124

(STRETCHING.)

2125

BY MR. WADE:

2126

MR. WADE: AND WHILE THEY'RE STRETCHING, DOCTOR, I'M GOING TO ASK YOU TO GO TO 10451 IN THE BLACK BINDER, WHICH I BELIEVE MIGHT BE ONE OF THE EARLIER EXHIBITS IN BINDER 2.

2127

ADAM ROSENDORFF: I'VE GOT IT.

2128

MR. WADE: AND THIS IS AN EMAIL CHAIN WITHIN A GROUP OF PEOPLE AT THERANOS THAT INCLUDES YOU AND RELATES TO SOME PROFICIENCY TESTING; IS THAT CORRECT?

2129

ADAM ROSENDORFF: THE EMAIL IS FROM LANGLY GEE TO A NUMBER OF RECIPIENTS. I AM ONE OF THEM.

2130

MR. WADE: OKAY. MOVE THE ADMISSION OF 10451.

2131

MR. BOSTIC: YOUR HONOR, I APOLOGIZE. I'M STILL LOOKING FOR THIS ONE.

2133

MR. WADE: 10451, YOUR HONOR. I BELIEVE IT'S THE FIRST DOCUMENT IN THE SECOND BINDER.

2134

MR. BOSTIC: NO OBJECTION, YOUR HONOR.

2135

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

2136

(DEFENDANT'S EXHIBIT 10451 WAS RECEIVED IN EVIDENCE.)

2137

BY MR. WADE:

2138

MR. WADE: OKAY. AND THIS IS AN EMAIL CHAIN, AS YOU NOTED, WITH LANGLY GEE, YOURSELF, AND A NUMBER OF OTHER PEOPLE AT THERANOS. DO YOU SEE DAN EDLIN THERE?

2140

MR. WADE: AND BRAD ARINGTON?

2142

MR. WADE: AND DR. PANDORI?

2144

MR. WADE: OKAY. I'D LIKE TO START AT THE BACK OF THE EMAIL. DO YOU SEE THAT EMAIL?

2146

MR. WADE: AND IN THIS EMAIL, MR. EDLIN IS ASKING FOR AN UPDATE ON PROFICIENCY TESTING; CORRECT?

2148

MR. WADE: AND HE NOTES THAT, "EAH HAS ASKED FOR THIS AS PART OF A PRESENTATION SHE IS COMPILING FOR TOMORROW." DO YOU SEE THAT?

2150

MR. WADE: AND YOU RESPONDED, IF WE CAN GO UP THE CHAIN. DO YOU SEE THAT THIS IS YOUR RESPONSE? YOUR RESPONSE IS ACTUALLY ON THE NEXT PAGE, BUT DO YOU SEE THAT THIS IS YOUR RESPONSE?

2152

MR. WADE: AND IT SAYS, "WE ARE CONTINUALLY DOING PROFICIENCY TESTING. LANGLY OR BRAD CAN FILL YOU IN ON THE STATE BY STATE APPLICATIONS/STATUS." CORRECT?

2153

ADAM ROSENDORFF: YES, WE DID PROFICIENCY TESTING ON THE PREDICATE INSTRUMENTS.

2154

MR. WADE: RIGHT. YOU'RE DOING PROFICIENCY TESTING ON THE PREDICATE INSTRUMENTS, AND YOU'RE DIRECTING MR. EDLIN TO EITHER LANGLY OR BRAD; CORRECT?

2156

MR. WADE: AND BRAD ARINGTON WAS A REGULATORY LAWYER WHO WORKED WITHIN THE COMPANY; RIGHT?

2157

ADAM ROSENDORFF: HE WAS GENERAL COUNSEL AT THE TIME I BELIEVE.

2158

MR. WADE: OKAY. AND HE FREQUENTLY WAS DEALING WITH DIFFERENT REGULATORY ISSUES RELATING TO CLIA; CORRECT?

2160

MR. WADE: OKAY. AND THEN IF WE GO UP THE CHAIN THERE'S SOME ADDITIONAL DISCUSSION, BUT IF I CAN DRAW YOUR ATTENTION TO THE MAY 8TH EMAIL AT 6:39. DO YOU SEE THAT?

2162

MR. WADE: THIS SAYS, THIS SAYS -- THIS SETS FORTH THE SURVEYS PERFORMED AND SCORES AND UPDATE TO THE LICENSES. DO YOU SEE THAT?

2164

MR. WADE: AND IT SETS FORTH A NUMBER OF RESULTS FROM PROFICIENCY TESTING BELOW?

2166

MR. WADE: AND THEY'RE ALL 100 PERCENT; CORRECT?

2168

MR. WADE: AND SPECIFICALLY DO YOU SEE WHERE IT SAYS CAP HIV?

2170

MR. WADE: AND THAT'S 10 PERCENT?

2172

MR. WADE: OKAY. LET'S GO --

2173

ADAM ROSENDORFF: AND WHEN WE RAN HIV ON AN ABBOTT INSTRUMENT, IT WAS AN FDA APPROVED INSTRUMENT.

2174

MR. WADE: CORRECT. AND IT WAS A TWO-PART TEST; CORRECT?

2175

ADAM ROSENDORFF: I DON'T RECALL.

2176

MR. WADE: DO YOU RECALL THE PROTOCOL THAT YOU USED FOR HIV?

2177

ADAM ROSENDORFF: IT WAS MOLECULAR TEST.

2178

MR. WADE: LET ME GO -- I DON'T HAVE ANYTHING ELSE IN THIS DOCUMENT. ACTUALLY, I WANT TO LOOK AT THE -- LET ME LOOK AT THE ATTACHMENT TO THE DOCUMENT. NOW, IF WE JUST LOOK AT THE TOP FIRST. THIS IS ADDRESSED TO YOU; RIGHT?

2180

MR. WADE: BECAUSE YOU WERE THE LAB DIRECTOR?

2182

MR. WADE: AND THIS IS DOCUMENTATION OF THE PROFICIENCY TESTING RESULTS; CORRECT?

2184

MR. WADE: AND IF WE ZOOM BACK OUT, THIS SETS FORTH THE DIFFERENT RESULTS. DO YOU SEE THAT?

2186

MR. WADE: AND IF WE CAN HIGHLIGHT THE GREY COLUMN ON THE RIGHT. DO YOU SEE IT SAYS ACCEPTABLE THERE?

2188

MR. WADE: AND IT SAYS ACCEPTABLE, IF WE GO BACK, ON ALL OF THE TESTS ON THE FIRST PAGE; CORRECT?

2189

ADAM ROSENDORFF: WE WERE NOT PERFORMING BACTERIAL IDENTIFICATION OR SUSCEPTIBILITY AT THERANOS USING THESE TECHNIQUES. THESE -- I DON'T RECALL WHY THIS PROFICIENCY WAS DONE, BUT WE WEREN'T DOING GRAM STAINS OR CULTURE BACTERIA OR ANYTHING LIKE THAT.

2190

MR. WADE: DO YOU THINK THESE TESTS WERE SENT TO THE WRONG LAB?

2192

MR. WADE: DO YOU THINK THEY WERE RUN AT THERANOS?

2193

ADAM ROSENDORFF: THEY WERE RUN AT THERANOS.

2194

MR. WADE: OKAY. AND ALL OF THEM WERE ACCEPTABLE; CORRECT?

2196

MR. WADE: AND DO YOU THINK THAT THAT'S AN INDICATION OF GOOD LAB PRACTICES THAT, WHETHER YOU'RE RUNNING THEM REGULARLY OR NOT, PEOPLE WERE EXECUTING WELL WHEN THEY WERE PERFORMING THE TESTS?

2197

ADAM ROSENDORFF: MY UNDERSTANDING -- MY RECOLLECTION IS THAT CHI NGUYEN WAS IN CHARGE OF MICROBIOLOGY AND THE COMPANY WAS CONSIDERING DOING TRADITIONAL CULTURE GRAM STAIN, AND IN PREPARATION FOR THAT THEY WERE RUNNING PROFICIENCY.

2198

MR. WADE: SO WE TALKED ABOUT BEFORE WHEN YOU VALIDATE ASSAYS, YOU NEED TO MEASURE THEM AGAINST A GOLD STANDARD; RIGHT?

2200

MR. WADE: AND SO IN ORDER TO HAVE A GOLD STANDARD THAT YOU CAN MEASURE A NEW ASSAY YOU'RE DEVELOPING AGAINST, YOU NEED TO, YOU NEED TO PUT THAT GOLD STANDARD ASSAY UP WITHIN YOUR LAB; RIGHT?

2202

MR. WADE: AND MAKE SURE THAT IT PERFORMS WELL?

2204

MR. WADE: AND SO DO YOU THINK IT'S POSSIBLE THAT THESE WERE PUT UP INTO THE LAB SO THAT THEY COULD SERVE AS THE GOLD STANDARD FOR ASSAYS THAT WERE UNDER DEVELOPMENT?

2205

ADAM ROSENDORFF: IT'S POSSIBLE.

2206

MR. WADE: OKAY. LET'S GO TO 10029, WHICH SHOULD BE IN YOUR BINDER 1 TOWARDS THE BACK.

2207

ADAM ROSENDORFF: I DON'T HAVE IT.

2208

MR. WADE: IN BINDER 1. EXHIBIT BINDER 1, TOWARDS THE BACK OF THE EXHIBIT, 10029.

2209

ADAM ROSENDORFF: I DO NOT HAVE IT. I GO FROM 9412 TO 12531.

2210

MR. WADE: WE'LL GET ANOTHER COPY IN JUST ONE SEC WITH THE COURT'S INDULGENCE.

2211

COURT CLERK: COUNSEL (HANDING.)

2213

BY MR. WADE:

2214

MR. WADE: SIR, DO YOU HAVE 10029 IN FRONT OF YOU?

2216

MR. WADE: AND DO YOU SEE THE DOCUMENT IS ADDRESSED TO YOU?

2218

MR. WADE: AND WHAT IS THIS DOCUMENT?

2219

ADAM ROSENDORFF: IT'S A PROFICIENCY TESTING EVENT THAT OCCURRED IN 2014. I'M LOOKING AT GENERAL CHEMISTRIES AND WHEN -- I'M SORRY.

2220

MR. WADE: GO AHEAD.

2221

ADAM ROSENDORFF: AND THESE WERE PERFORMED -- I'M SORRY. THESE ARE IMMUNOASSAYS, OKAY, PERFORMED AT THERANOS USING THE FDA APPROVED IMMULITE INSTRUMENT, AND THIS DOCUMENT SHOWED THE RESULT THAT THERANOS OBTAINED AND THE EXPECTED RESULTS FOR EACH PROFICIENCY SAMPLE FOR EACH ANALYTE.

2222

MR. WADE: I MOVE THE ADMISSION OF 10029.

2223

MR. BOSTIC: NO OBJECTION.

2224

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

2225

(DEFENDANT'S EXHIBIT 10029 WAS RECEIVED IN EVIDENCE.)

2226

BY MR. WADE:

2227

MR. WADE: YOU GAVE A PRETTY COMPREHENSIVE ANSWER, SO WE CAN PROBABLY MOVE THROUGH THIS QUICKLY. THIS WAS A PROFICIENCY TESTING DOCUMENT FOR THE GENERAL CHEMISTRY ASSAYS?

2228

ADAM ROSENDORFF: IMMUNOASSAY.

2229

MR. WADE: I'M SORRY, IMMUNOASSAYS. LET'S LOOK JUST IN THE UPPER LEFT-HAND CORNER. DO YOU SEE THAT?

2231

MR. WADE: AND THIS SAYS IT'S THE THIRD EVENT?

2233

MR. WADE: WHAT DOES THAT MEAN?

2234

ADAM ROSENDORFF: UM, TYPICALLY THERE'S THREE CHALLENGES SENT TO A LAB EACH YEAR. THIS WOULD BE THE THIRD OF THOSE THREE CHALLENGES.

2235

MR. WADE: OKAY. AND IF WE CAN GO BACK TO THE DOCUMENT AND HIGHLIGHT THE COLUMN ALL OF THE WAY TO THE LEFT ALL OF THE WAY DOWN. THESE ARE THE ASSAYS THAT WERE TESTED FOR PROFICIENCY TESTING; CORRECT?

2236

ADAM ROSENDORFF: YES, AND IT'S ALSO CONTINUED ON THE REVERSE PAGE.

2237

MR. WADE: AND IT'S CONTINUED ON THE REVERSE PAGE. LET'S LOOK AT THOSE. AND ALL OF THESE TESTS PASSED PROFICIENCY TESTING; CORRECT?

2238

ADAM ROSENDORFF: YES, WITH THE EXCEPTION OF BETA-2 MICROGLOBULIN, WHICH WAS NOT GRADED.

2239

MR. WADE: RIGHT. SO ALL OF THE TESTS THAT WERE GRADED PASSED; RIGHT?

2241

MR. WADE: CERTIFYING THAT THEY WERE ACCURATE; CORRECT?

2242

ADAM ROSENDORFF: AGAIN, THESE ARE ON THE IMMULITE INSTRUMENT, YES.

2243

MR. WADE: AND THEY'RE ON THE IMMULITE INSTRUMENT; CORRECT?

2245

MR. WADE: AND THEY'RE CERTIFYING THAT THESE TESTS ARE ACCURATE; RIGHT?

2248

ADAM ROSENDORFF: SO ACTUALLY, SOME OF THESE APPEAR TO HAVE BEEN RUN ON THE ADVIA. IF YOU LOOK AT PREALBUMIN, IT LOOKS LIKE THAT WAS RUN ON THE ADVIA, ON TRANSFER IT WAS RUN ON THE ADVIA.

2249

MR. WADE: OKAY. SO THE TESTS WERE RUN EITHER ON THE ADVIA OR THE IMMULITE, BUT THEY ALL PASSED CERTIFYING THEIR ACCURACY; CORRECT?

2250

ADAM ROSENDORFF: AND THEN THE MICROALBUMIN WAS RUN ON THE DCA VANTAGE.

2251

MR. WADE: AND I JUST WANT TO CONFIRM BECAUSE THERE WAS SOME QUESTIONS THAT YOU HAD ABOUT WHETHER THERE WAS A PROFICIENCY TESTING POLICY IN PLACE IN SEPTEMBER OF 2013, OKAY? SO I WANT TO CLARIFY THAT. IF WE CAN LOOK AT EXHIBIT 13905. AND I BELIEVE 13905 WILL BE TOWARDS THE BACK OF YOUR SECOND VOLUME. AND FOR THE COURT, IT'S IN THE RED WELD.

2252

ADAM ROSENDORFF: I HAVE 13905.

2253

MR. WADE: OKAY. AND THIS IS AN EMAIL BETWEEN SYLVIA CHANG AND MR. BALWANI RELATING TO PROFICIENCY TESTING DETAILS; RIGHT?

2255

MR. WADE: MOVE THE ADMISSION OF 13905.

2256

MR. BOSTIC: NO OBJECTION.

2257

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

2258

(DEFENDANT'S EXHIBIT 13905 WAS RECEIVED IN EVIDENCE.)

2259

BY MR. WADE:

2260

MR. WADE: JUST SO WE RECALL THE TESTIMONY AT THE END OF YOUR DIRECT WHETHER THERE WAS A PROFICIENCY TESTING PROGRAM IN PLACE AT THERANOS IN SEPTEMBER OF 2013, YOU BELIEVE THAT WAS MISTAKEN TESTIMONY; CORRECT?

2261

ADAM ROSENDORFF: MY RECOLLECTION IS THAT WE WERE PERFORMING PROFICIENCY TESTING USING THE API CAP AND NEW YORK STATE SAMPLES.

2264

MR. WADE: AND LET'S LOOK AT THIS EMAIL. THIS IS AN EMAIL TO MR. BALWANI; CORRECT?

2266

MR. WADE: AND IT'S FROM SYLVIA CHANG. WHO IS SYLVIA CHANG?

2267

ADAM ROSENDORFF: I DO NOT REMEMBER.

2268

MR. WADE: SHE WAS AN EMPLOYEE THAT DIDN'T WORK LONG OR SOMETHING? OKAY. AND THIS IS IN JULY OF 2013; RIGHT?

2270

MR. WADE: AND THIS IS BEFORE THE SOFT LAUNCH?

2272

MR. WADE: AND IT'S BEFORE THE PUBLIC LAUNCH?

2274

MR. WADE: AND SHE'S FOLLOWING UP ON INFORMATION THAT MR. BALWANI REQUESTED WITH RESPECT TO THE SCHEDULING AND SUBMISSION OF PROFICIENCY SAMPLES; RIGHT?

2276

MR. WADE: AND IF -- AND SHE SETS FORTH, IS IT FAIR TO SAY, IN RELATIVELY SORT OF DETAILED OUTLINE OF THE PROCESS AND WHAT WOULD BE INVOLVED IN IMPLEMENTING THAT?

2278

MR. WADE: OKAY. AND IF WE GO TO THE BOTTOM, YOU SEE THERE IT SAYS, "ADAM/KERRY/HODA - PLEASE ADD TO THE LIST IF I HAVE MISSED ANYTHING." DO YOU SEE THAT?

2280

MR. WADE: AND DO YOU RECALL WHETHER YOU ADDED ANYTHING TO THE LIST OR DO YOU THINK SHE COVERED IT SUFFICIENTLY?

2281

ADAM ROSENDORFF: I DO NOT RECALL.

2282

MR. WADE: NOW, LET'S TALK A LITTLE BIT ABOUT AAP. DO YOU RECALL THAT THERE WAS AN AAP POLICY THAT WAS PUT IN PLACE AT THERANOS?

2283

ADAM ROSENDORFF: I'M SORRY. I WROTE AN SOP AND THEN IT WAS OVERWRITTEN ESSENTIALLY BY GODFREY, SO I CAN TESTIFY THAT THE AAP WAS NEVER IMPLEMENTED FOR THE THERANOS TEST.

2284

MR. WADE: I UNDERSTAND THAT'S YOUR TESTIMONY. MY QUESTION IS, WAS THERE AN AAP POLICY THAT WAS PUT IN PLACE AT THERANOS?

2285

ADAM ROSENDORFF: I BELIEVE THERE WAS AN SOP THAT WAS WRITTEN, RIGHT, AND APPROVED BY ME.

2286

MR. WADE: AND DO YOU RECALL WHEN YOU CREATED THAT SOP?

2287

ADAM ROSENDORFF: I DO -- I THINK IT WAS SOMETIME IN 2014.

2290

MR. WADE: OKAY. I THINK YOU TESTIFIED ON DIRECT THAT YOU HAD DISCUSSED A NEED FOR AAP TESTING WITH DR. YOUNG; IS THAT CORRECT?

2292

MR. WADE: AND THERE WAS A NEED TO PUT A POLICY IN PLACE THAT WOULD ADDRESS THE EDISON DEVICES; CORRECT?

2294

MR. WADE: AND THAT WAS BECAUSE THERE WAS A BELIEF WITHIN THE COMPANY AT THAT TIME THAT THEY WOULD NEED A DIFFERENT PROCEDURE FROM TRADITIONAL PROFICIENCY TESTING?

2296

MR. WADE: AND LET ME SHOW YOU WHAT IS MARKED AS DOCUMENT 1580.

2297

ADAM ROSENDORFF: WHICH BINDER ARE WE IN?

2298

MR. WADE: IT'S IN EVIDENCE. I BELIEVE THIS IS ONE OF THE DOCUMENTS THAT THE GOVERN SHOWED YOU YESTERDAY, SO IT'S PROBABLY WITHIN THE WHITE BINDER.

2300

MR. WADE: OKAY. DO YOU RECALL BEING SHOWN THIS DOCUMENT YESTERDAY?

2302

MR. WADE: AND DO YOU RECALL THAT THIS IS THE DOCUMENT WHERE MS. HOLMES SUGGESTED THAT REGULATORY COUNSEL SHOULD BE, SHOULD BE CONSULTED ON THE PRECISION TESTING POLICY AND YOU WERE OFFENDED BY THAT; RIGHT?

2303

ADAM ROSENDORFF: PROFICIENCY TESTING NOT PRECISION TESTING.

2304

MR. WADE: OKAY. SO LET ME TRY AGAIN AND CLARIFY. I APOLOGIZE. YOU RECALL THAT THIS WAS A DOCUMENT THAT RELATED TO PROFICIENCY TESTING. MS. HOLMES SUGGESTED THAT YOU --

2305

ADAM ROSENDORFF: THIS EMAIL RELATED TO PROFICIENCY TESTING.

2306

MR. WADE: OKAY. AND YOU RECALL BEING ASKED ABOUT THIS AND MS. HOLMES'S COMMENTS IN PARTICULAR?

2308

MR. WADE: OKAY. LET'S START AT THE BACK OF THE EMAIL. OKAY. HERE -- AND JUST SO WE'RE CLEAR, YOU GAVE TESTIMONY YESTERDAY THAT THERE WAS NO -- I THINK YOU SAID THERE WAS NO PROFICIENCY TESTING POLICY AT THERANOS.

2309

ADAM ROSENDORFF: I DIDN'T, I DIDN'T -- I DON'T RECALL EXACTLY WHAT MY TESTIMONY WAS. I SAW THAT SYLVIA REFERENCED AN ATTACHED POLICY IN THE EMAIL THAT WE REVIEWED A WHILE AGO. I DO NOT RECALL SEEING A POLICY OR A PROCEDURE IN PLACE FOR PROFICIENCY TESTING.

2310

MR. WADE: OKAY. AND YOU RECALL THAT THERE WAS ACTUALLY SPECIFICALLY AN AAP POLICY THAT WAS PUT IN PLACE?

2311

ADAM ROSENDORFF: AGAIN, I WROTE ONE AND SIGNED IT. IT WAS REWRITTEN BY GODFREY, AND IT WAS NEVER IMPLEMENTED.

2312

MR. WADE: AND WHOSE RESPONSIBILITY IS IT TO IMPLEMENT THE AAP POLICY UNDER CLIA LAW?

2313

ADAM ROSENDORFF: IT'S DELEGATED TO THE TECHNICAL SUPERVISOR. IT'S ULTIMATELY THE LAB DIRECTOR'S RESPONSIBILITY. HOWEVER, IT REQUIRES A LARGE CONCERTED EFFORT BY THE ENTIRE OPERATIONS TEAM, RESOURCES, SUPPORT BY MANAGEMENT. GIVEN THE NUMBER AND COMPLEXITY OF LDT'S THAT WE WERE DOING, IT WAS NOT SOMETHING THAT I COULD HAVE ACHIEVED ON MY OWN.

2314

MR. WADE: YOUR HONOR, I WOULD MOVE TO STRIKE EVERYTHING AFTER LABORATORY DIRECTOR.

2315

(PAUSE IN PROCEEDINGS.)

2316

JUDGE DAVILA: ALL RIGHT. THANK YOU. I'LL STRIKE EVERYTHING AFTER THE WORDS "DIRECTOR'S RESPONSIBILITY." RESPONSIBILITY WILL BE STRICKEN, LADIES AND GENTLEMEN, AS NONRESPONSIVE TO THE QUESTION.

2317

BY MR. WADE:

2318

MR. WADE: LET'S TURN BACK TO THE DOCUMENT. DO YOU SEE THIS IS A NOVEMBER 26TH, 2013 EMAIL FROM DANIEL YOUNG TO YOU COPYING MS. HOLMES AND MR. BALWANI?

2320

MR. WADE: AND IT SAYS AT THE TOP, "HERE ARE MY SUGGESTIONS THAT I DISCUSSED WITH ADAM."

2322

MR. WADE: DO YOU SEE THAT?

2324

MR. WADE: AND HE TALKS IN DETAIL ABOUT -- HE SAYS THERE ARE 91 TESTS THAT CLIA REGULATED AND REQUIRES PROFICIENCY TESTING?

2326

MR. WADE: DO YOU SEE THAT? AND THEN HE -- IN THE SECOND PARAGRAPH HE TALKS ABOUT -- HE SAYS, "FOR OUR LDT'S, ALL OF WHICH ARE CLIA REGULATED AT THE MOMENT, WE NEED SOP'S FOR PT." RIGHT?

2328

MR. WADE: AND HE TALKS ABOUT THE PROCESS FOR THAT; RIGHT?

2329

ADAM ROSENDORFF: HE PROPOSES DIFFERENT METHODS OF ALTERNATIVE PT.

2330

MR. WADE: RIGHT. IF WE GO DOWN BELOW, HE MAKES A PROPOSAL TO YOU FOR WHAT HE THINKS SHOULD BE CONSIDERED TO TEST THE ACCURACY OF THE EDISON DEVICES; RIGHT?

2332

MR. WADE: AND HE'S --

2333

ADAM ROSENDORFF: SO HE'S -- JUST TO CLARIFY, HE'S NOT SPECIFICALLY TALKING ABOUT THE EDISONS HERE. THE SUBJECT OF THE EMAIL IS PROFICIENCY TESTING FOR LDT'S. THAT WOULD ENCOMPASS ALL OF THE LDT'S USED AT THERANOS.

2334

MR. WADE: HE'S TALKING ABOUT ALL OF THE LDT'S?

2336

MR. WADE: OKAY. AND DOWN IN THE BOTTOM PART OF THAT EMAIL, RIGHT, HE SAYS -- HE SETS FORTH SOME OF THE DETAILS TO INCLUDE THAT; RIGHT?

2338

MR. WADE: DO YOU SEE THAT? AND INCLUDING THAT AAP SHOULD BE DONE TWICE PER YEAR; RIGHT?

2340

MR. WADE: AND THAT'S, THAT'S THE REQUIREMENT UNDER CLIA; CORRECT?

2341

ADAM ROSENDORFF: I BELIEVE SO, YES.

2342

MR. WADE: AND YOU HAVE TO DO PROFICIENCY TESTING OR ALTERNATIVE TESTING ON YOUR PRIMARY METHOD FOR A PARTICULAR ASSAY; CORRECT?

2344

MR. WADE: YOU HAVE TO DO IT EVERY SIX MONTHS FROM THE POINT AT WHICH THAT BECOMES YOUR PRIMARY METHOD; CORRECT?

2346

MR. WADE: OKAY. THE -- AND HE PROPOSES THE CONTENTS OF THE SOP FOR THAT ALTERNATIVE ASSESSMENT PROTOCOL; RIGHT?

2348

MR. WADE: OKAY. AND IF WE GO UP ONE EMAIL, IT STARTS ON THE BOTTOM OF THE NEXT PAGE. DO YOU SEE THAT? THIS IS FROM YOU LATER THAT SAME DAY, NOVEMBER 26TH, 2013?

2350

MR. WADE: OKAY. AND JUST SO WE CAN UNDERSTAND, THIS 2013, NOVEMBER 26TH, THIS IS JUST AFTER THE PUBLIC LAUNCH OF THERANOS; RIGHT?

2352

MR. WADE: AND IF THAT WAS THE DATE OF THE PUBLIC LAUNCH, YOU WOULDN'T NEED TO DO AAP FOR PROBABLY FIVE OR SIX MONTHS; RIGHT?

2353

ADAM ROSENDORFF: YEAH. SO THE CLIA REGULATIONS SAY THAT PROFICIENCY TESTING SHOULD BE DONE AT SOME FREQUENCY. I DON'T RECALL EXACTLY WHAT THE REGS SAY. I DON'T KNOW IF IT'S FROM THE TIME THAT A METHOD BECOMES YOUR PRIMARY METHOD, BUT THEY DO SAY THAT IT SHOULD BE PERFORMED ON THE PRIMARY METHOD.

2354

MR. WADE: RIGHT, ON THE PRIMARY METHOD, AT SOME INTERVALS. BUT IT'S NOT LIKE QUALITY CONTROL WHERE YOU DO IT EVERY DAY; RIGHT?

2356

MR. WADE: AND THIS IS ONCE -- TWICE OR THREE TIMES A YEAR; RIGHT?

2358

MR. WADE: AND YOU SAY -- IF WE CAN GO TO THE SUBSTANCE OF YOUR EMAIL. YOU SAY, "I'LL WRITE UP THE SOP AND INCORPORATE WHAT WE HAVE DISCUSSED." RIGHT?

2360

MR. WADE: AND I DIDN'T HIGHLIGHT IT IN THE EMAIL BELOW, BUT IN THE EMAIL BELOW, WHAT DR. YOUNG, HE NOTED THAT THERE WERE -- YOU AND HE HAD A DISCUSSION; RIGHT? THAT'S HOW HE STARTED THE EMAIL?

2362

MR. WADE: AND SO HE'S WORKING WITH YOU TO DEVELOP THIS; CORRECT?

2364

MR. WADE: AND THEN IF WE CAN GO UP A COUPLE OF EMAILS TO MR. PANDORI'S EMAIL AT 5:20 P.M. DO YOU SEE THAT?

2366

MR. WADE: AND HE SAYS -- MR. GEE SAYS TO -- I'M SORRY. MR. PANDORI SAYS TO MR. GEE, "PLEASE SHARE WITH DANIEL THE COMPARISON OF PREDICATE AND EDISON FOR THE PT SPECIMENS WE TESTED." DO YOU SEE THAT?

2368

MR. WADE: AND DOES THAT INDICATE THAT THERE WAS SOME AT LEAST EXPERIMENTAL PRECISION TESTING THAT WAS GOING ON DURING THIS TIME PERIOD?

2369

ADAM ROSENDORFF: AGAIN, PROFICIENCY, NOT PRECISION. YOU SAID PRECISION. I THINK YOU MEANT PROFICIENCY.

2371

ADAM ROSENDORFF: YEAH. THERE WAS LEFTOVER PT SPECIMENS FROM A VARIETY OF SOURCES. THEY WERE RUN ON SOME EDISON INSTRUMENTS AND COMPARED TO THE RESULTS FROM THE IMMULITE.

2372

MR. WADE: OKAY. AND AS WE WORK UP THE CHAIN, IF WE GO TO THE 8:25 P.M., THERE'S DISCUSSION WITH MR. BALWANI ABOUT THIS; RIGHT?

2374

MR. WADE: AND HE SAYS HE WOULD LIKE TO SEE THESE RESULTS THAT WERE RUN; RIGHT?

2376

MR. WADE: ON THE EDISONS?

2378

MR. WADE: BECAUSE IT LOOKS LIKE THERE WAS SOME PROFICIENCY TESTING THAT WAS DONE ON THE EDISONS; RIGHT?

2380

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

2381

ADAM ROSENDORFF: I -- NEVER MIND.

2382

MR. WADE: DO YOU SEE IT GO UP ONE CHAIN? DO YOU SEE THAT?

2384

MR. WADE: AND IT SAYS, "WE ALSO NEED INFORMATION ABOUT THE PT SAMPLES, SUCH AS WHAT THE MATRIXES WERE." RIGHT?

2386

MR. WADE: AND HE WANTS TO GET THIS INFORMATION; RIGHT?

2388

MR. WADE: OKAY. AND THEN IF WE JUMP UP TO FEBRUARY 24TH -- AND I SHOULD MAKE CLEAR. I DON'T KNOW IF YOU CAUGHT WHAT HAPPENED. I DON'T WANT TO IN ANY WAY MISLEAD YOU. THERE WAS AN EMAIL THAT WAS FORWARDED FROM 2013 WHERE YOU AND DANIEL WERE DISCUSSING THE POLICY; RIGHT?

2390

MR. WADE: DO YOU SEE THAT?

2392

MR. WADE: AND THAT'S BEING FORWARDED IN FEBRUARY OF 2013. DO YOU SEE THAT? THERE'S A SWITCH IN YEARS THERE BECAUSE -- AND DO YOU SEE DANIEL'S EMAIL, IF WE CAN GO TO THE BOTTOM OF PAGE 4. DO YOU SEE THAT?

2394

MR. WADE: AND THAT'S 2013. AND THEN THE NEXT EMAIL ABOVE THAT DANIEL FORWARDS TO MR. PANDORI IN FEBRUARY OF 2014?

2395

ADAM ROSENDORFF: I SEE IT. I SEE IT.

2396

MR. WADE: OKAY. IS THAT HELPFUL TO YOUR UNDERSTANDING OF WHAT HAPPENED?

2397

ADAM ROSENDORFF: YES. HE WANTED TO GET MARK PANDORI IN THE LOOP ABOUT WHAT THE THOUGHTS WERE REGARDING ALTERNATIVE ASSESSMENT OF PROFICIENCY.

2398

MR. WADE: AND THAT ALL RELATES TO THE DATA IN MS. CHEUNG'S EMAIL THAT WE LOOKED AT; RIGHT?

2400

MR. WADE: AND THAT DATA THAT WAS DERIVING FROM RUNNING PROFICIENCY TESTING SAMPLES, TRADITIONAL PROFICIENCY TESTING SAMPLES ON AN EDISON; RIGHT?

2402

MR. WADE: WHICH WAS NOT CONSISTENT WITH THE POLICY THAT YOU AND DR. YOUNG HAD DEVELOPED BACK IN 2013; CORRECT?

2404

MR. WADE: OKAY. AND THE REASON THIS IS BEING REFORWARDED BY YOU IS TO REMIND EVERYBODY ABOUT THE POLICY --

2405

ADAM ROSENDORFF: THAT WAS REFORWARDED BY DANIEL.

2406

MR. WADE: LET'S GO BACK OR DOWN ONE EMAIL. RIGHT. SO THIS IS SENT FROM YOU TO DANIEL AND TO MS. HOLMES AND MR. BALWANI IN NOVEMBER OF 2013; RIGHT?

2408

MR. WADE: AND SO THE EXPECTATION BEING THAT THIS WAS -- THE POLICY THAT WE HAD JUST DISCUSSED WAS GOING TO BE THE POLICY THAT WOULD BE APPLIED; CORRECT? YOU FORWARDED THIS TO THE SENIOR MANAGEMENT OF THE COMPANY?

2409

ADAM ROSENDORFF: SO WHAT I FORWARDED TO ELIZABETH AND SUNNY IN NOVEMBER 26TH, 2013 WAS A STATEMENT, DANIEL, THANKS, I'LL WRITE UP THE SOP AND INCORPORATE WHAT WE HAVE DISCUSSED.

2410

MR. WADE: RIGHT. RIGHT. I'M SORRY FOR THE CONFUSION, DR. ROSENDORFF.

2412

MR. WADE: LET'S GO BACK TO THAT FIRST EMAIL. OKAY. THIS LAYS OUT THE AAP POLICY THAT YOU WERE GOING TO APPLY TO ASSESS THE ACCURACY OF THE EDISON DEVICES; RIGHT?

2413

ADAM ROSENDORFF: IT'S A PROPOSAL BY DANIEL, YES.

2414

MR. WADE: IT'S A PROPOSAL BY DANIEL. AND THEN YOU SAY YOU'RE GOING TO WRITE IT UP AS AN SOP; RIGHT?

2416

MR. WADE: AND THEN YOU FORWARD, IN 2013, THE FACT THAT YOU'RE GOING TO WRITE IT UP AS AN SOP TO MR. YOUNG AND TO MS. HOLMES AND MR. BALWANI; CORRECT?

2418

MR. WADE: OKAY. AND DR. YOUNG FORWARDS THAT TO MR. PANDORI, WHO WAS INVOLVED WITH MS. CHEUNG IN THAT USE OF THE PROFICIENCY TESTING MATERIAL ON THE EDISON; RIGHT?

2420

MR. WADE: AND DR. PANDORI WAS NOT AT THE COMPANY BACK WHEN YOU AND DR. YOUNG CREATED THAT POLICY?

2422

MR. WADE: SO DR. YOUNG WAS FORWARDING THAT TO HIM; CORRECT?

2424

MR. WADE: AND THEN MR. PANDORI, GOING BACK UP THE EMAIL NOW THAT WE'RE ON THE SAME PAGE, MR. PANDORI SAYS, "PLEASE SHARE WITH DANIEL YOUNG THE COMPARISON OF PREDICATE AND EDISON FOR THE PT SPECIMENS WE TESTED." RIGHT?

2426

MR. WADE: AND UNDER THE AAP POLICY FOR EDISONS, PT SPECIMENS WERE NOT SUPPOSED TO BE TESTED?

2428

MR. WADE: OKAY. AND LET'S GO UP THE CHAIN FURTHER. LET'S SKIP TO MR. BALWANI'S EMAIL ON FEBRUARY 24, 2014. THIS WAS AROUND THE TIME THAT MS. CHEUNG WAS SENDING THAT DATA AROUND; RIGHT?

2430

MR. WADE: AND THIS SAYS HERE, "WHERE AND WHO PULLED THE RESULTS?" MR. BALWANI WANTED TO SEE THE DATA; RIGHT?

2432

MR. WADE: OKAY. LET'S GO TO THE NEXT EMAIL. AND DR. YOUNG SAYS WE ALSO NEED INFORMATION ABOUT THE PT SAMPLES SUCH AS THE MATRIX AND OTHER MATERIALS. RIGHT? DO YOU SEE THAT?

2434

MR. WADE: AND HE THEN SAYS, "THESE PT SAMPLES ARE USUALLY FORMULATED WITH CERTAIN TEST SYSTEMS IN MIND." RIGHT?

2436

MR. WADE: AND HE THEN SAYS, "THIS IS ONE OF THE REASONS I AM NOT COMFORTABLE USING THEM WITHOUT A PEER GROUP." RIGHT?

2438

MR. WADE: AND THAT'S BECAUSE WE HAD TALKED ABOUT SOME OF THOSE INTERFERENCES AND THINGS; RIGHT? DO YOU RECALL THAT TESTIMONY A LITTLE BIT AGO? HOW SOMETIMES TESTS RESPOND TO OTHER ELEMENTS IN THE MATERIAL?

2440

MR. WADE: AND IT'S SOMETIMES REFERRED TO AS A MATRIXES; IS THAT RIGHT?

2441

ADAM ROSENDORFF: NO. WE DISCUSSED ICTERUS, LIPEMIA AND HEMOLYSIS AS PART OF THE SPECIFICITY DISCUSSION WITH MR. BALWANI. THOSE SUBSTANCES CAN INTERFERE WITH DETECTION OF ANALYTES. WHAT DANIEL IS TALKING ABOUT HERE IS WHAT IS THE MATRIX, IN OTHER WORDS, IS THE MATRIX MADE UP TO RESEMBLE SERUM? IS IT BEING MADE UP TO RESEMBLE CAPILLARY BLOOD? WHAT IS IN THE PT MATERIAL ITSELF?

2442

MR. WADE: BECAUSE THE PT MATERIAL THAT IS TESTED ON THE EDISON MAY NOT BE AN APPLES-TO-APPLES COMPARISON, RIGHT? IT MAY NOT BE A PEERED TEST?

2443

ADAM ROSENDORFF: I MEAN, I CAN EXPLAIN MY THINKING ABOUT THAT YOU IF WOULD LIKE.

2444

MR. WADE: WELL, LET'S GO UP THE EMAIL AND FOCUS ON WHAT HAPPENED AT THE TIME. LET'S GO UP TO THE FEBRUARY 24TH EMAIL FROM DR. YOUNG. I'M SORRY, ONE EMAIL UP. IT'S BURIED WITHIN -- IT SAYS, "ON FEBRUARY 24TH, 2014." NOW, THIS IS AN EMAIL -- ACTUALLY, I'M SORRY. THIS IS AN EMAIL FROM MR. BALWANI; CORRECT?

2445

ADAM ROSENDORFF: YES, HE'S -- IT APPEARS THAT HE'S QUOTING DANIEL HERE.

2446

MR. WADE: AND HE'S QUOTING AN EMAIL FROM DANIEL?

2448

MR. WADE: AND IT SAYS, "TO ADD MORE DETAILS ABOUT MY CONCERNS." AND JUST SO WE'RE CLEAR, YOU AND DANIEL HAD WORKED TOGETHER ON DEVELOPING THE AAP TEST; CORRECT?

2449

ADAM ROSENDORFF: ME AND DANIEL HAD DISCUSSED IT. I WROTE OUT AN SOP THAT WAS OVERWRITTEN BY THE G.S. THE AAP WAS NEVER IMPLEMENTED.

2450

MR. WADE: I UNDERSTAND YOUR ANSWER IN THAT REGARD. MY QUESTION WAS, YOU AND DANIEL WORKED TOGETHER TO DEVELOP THAT PROCEDURE; CORRECT?

2452

MR. WADE: CORRECT. AND HERE DANIEL IS QUOTED AS SAYING, "TO ADD MORE DETAILS ABOUT MY CONCERNS RELATING TO USING PT SAMPLES WITHOUT EXTENSIVE STUDY WITH OUR LDT'S AND WITHOUT A PEER GROUP, I WANTED TO HIGHLIGHT WHY THE PEER GROUP METHODS WERE ESTABLISHED FOR PT AND OTHER CHALLENGES RELATING TO MATRIX EFFECTS." DO YOU SEE THAT?

2454

MR. WADE: AND HE THEN SAYS, "THESE FACTORS ARE WHY I HAD RECOMMENDED LAST YEAR THE APPROACH THAT WE SINCE CAPTURED IN OUR CLIA SOP'S LAST YEAR." DO YOU SEE THAT?

2456

MR. WADE: "NAMELY, RUNNING PT ON FDA-CLEARED PREDICATES." THAT MEANS A BIG DEVICE IN THE LAB, ONE OF THE BIG MACHINES?

2457

ADAM ROSENDORFF: A DCA VANTAGE IS FDA APPROVED. IT'S PRETTY SMALL. IF YOU COULD BE MORE SPECIFIC, THAT WOULD BE HELPFUL TO ME.

2458

MR. WADE: IT WAS ONE OF THE GOLD STANDARD PREDICATES; RIGHT?

2459

ADAM ROSENDORFF: THE FDA APPROVED SIEMENS INSTRUMENT, YES.

2460

MR. WADE: YES. AND YOU WANTED TO COMPARE YOUR SAMPLES AGAINST THAT?

2462

MR. WADE: YEAH. AND RUNNING INTERNAL ALTERNATIVE ASSESSMENT PROGRAMS -- THAT'S AAP; RIGHT?

2464

MR. WADE: NAMELY, USING THE ACTUAL PATIENT SAMPLES; RIGHT?

2466

MR. WADE: "TO ENSURE THAT OUR LDT'S, ELISA, CYTO, AND GC, ARE ACCURATE WITH RESPECT TO THESE PREDICATES." DO YOU SEE THAT?

2468

MR. WADE: AND THAT'S HIS STATED GOAL?

2470

MR. WADE: AND THAT WAS IN THE SOP THAT YOU DRAFTED; RIGHT?

2472

MR. WADE: "NOTE THAT CAP IS DEVELOPING SOME UNMODIFIED SAMPLES FOR PT BUT THIS IS STILL IN DEVELOPMENT (SOMETHING WE SHOULD FURTHER ENGAGE CAP ON)." RIGHT?

2473

ADAM ROSENDORFF: I READ THAT.

2474

MR. WADE: AND DO YOU SEE THAT?

2476

MR. WADE: AND THEN HE QUOTES FROM SOME RESEARCH HE HAD DONE. DO YOU SEE THAT?

2478

MR. WADE: AND THEN THE LAST SENTENCE DOWN AT THE BOTTOM, HE SAYS, "THE PROPOSED INTERNAL AAP APPROACH WAS DEVISED TO OVERCOME THESE LIMITATIONS OF OUR LDT'S. LOOKING FORWARD TO DISCUSSING THESE MATTERS." RIGHT?

2480

MR. WADE: THAT'S WHAT HE SAID. BECAUSE THE POLICY THAT YOU -- THERE WERE CONCERNS RECOGNIZED ABOUT HOW MATRIX COULD AFFECT THE RESULT AND YOU TOGETHER DEVELOPED A POLICY THAT WAS DESIGNED TO ADJUST FOR THAT; RIGHT?

2481

ADAM ROSENDORFF: IN MY DISCUSSIONS WITH DANIEL, WE NEVER DISCUSSED MATRIX EFFECTS.

2483

ADAM ROSENDORFF: AND THESE ARE COMING UP IN FEBRUARY OF 2014, THESE CONCERNS, YEAH.

2484

MR. WADE: BUT YOU, YOU AGREED THAT THE AAP WAS THE APPROPRIATE METHOD?

2486

MR. WADE: OKAY. AND THAT'S WHAT SHOULD BE USED WHEN YOU'RE TESTING THOSE SAMPLES?

2488

MR. WADE: OKAY. AND THE, THE PT SPECIMENS THAT WERE USED IN THAT EXPERIMENT THAT MS. CHEUNG SENT YOU DATA ON WERE NOT SUPPOSED TO BE USED UNDER THE POLICY; RIGHT?

2489

ADAM ROSENDORFF: CORRECT. THAT WAS A -- THAT WAS A SPOT-CHECK, QC EXERCISE. THAT WAS NOT CAPTURED IN A PROCEDURE.

2490

MR. WADE: RIGHT. BUT MY QUESTION IS THAT THE AAP PROTOCOL THAT YOU SET UP UNDER THAT, YOU WERE NOT SUPPOSED TO USE THAT MATERIAL --

2491

ADAM ROSENDORFF: CORRECT, CORRECT.

2492

MR. WADE: -- TO ASSESS THE ACCURACY OF THERANOS'S EDISON DEVICES?

2494

MR. WADE: OKAY. LET'S -- NOW, WHEN YOU WERE SHOWN THIS BY THE GOVERNMENT, THEY DIDN'T SHOW YOU THAT PIECE, DID THEY?

2495

ADAM ROSENDORFF: WHICH PIECE?

2496

MR. WADE: THE PIECE FROM DR. YOUNG.

2497

ADAM ROSENDORFF: NO, THEY DIDN'T.

2498

MR. WADE: NO, THEY DIDN'T. AND THEN IF YOU LOOK ABOVE THAT, IT SAYS, "CC'ING ELIZABETH ON THIS AS WE WENT THRU THIS DISCUSSION OVER A YEAR AGO ALSO." DO YOU SEE THAT?

2500

MR. WADE: AND DO YOU REMEMBER ABOUT A YEAR AGO WAS WHEN YOU HAD FORWARDED WHAT YOU WERE GOING TO DO TO HER AS DISCUSSED WITH DR. YOUNG; RIGHT?

2501

ADAM ROSENDORFF: YES, YES. THERE WAS AN EMAIL THAT PROBABLY SAID OKAY, I WILL DO.

2502

MR. WADE: YEAH. WHERE YOU SAID YOU WERE GOING TO PREPARE THE SOP FOR AAP AS DISCUSSED; RIGHT?

2504

MR. WADE: AND THAT APPROACH HAD BEEN VETTED INTERNALLY; CORRECT?

2505

ADAM ROSENDORFF: I'M NOT SURE WHAT YOU MEAN.

2506

MR. WADE: WELL, YOU DISCUSSED IT WITH DR. YOUNG?

2508

MR. WADE: AND YOU FORWARDED IT TO YOUR DIRECT REPORT, MR. BALWANI; CORRECT?

2509

ADAM ROSENDORFF: SO JUST TO BE PERFECTLY CLEAR --

2510

MR. WADE: MY QUESTION -- THE QUESTION PENDING IS WHETHER YOU FORWARDED IT TO MR. BALWANI. THAT'S THE QUESTION.

2511

ADAM ROSENDORFF: I SAID, OKAY, WILL DO. THAT WAS THE MESSAGE FORWARDED TO MR. BALWANI. IT WAS NOT, IT WAS -- IT DID NOT INCLUDE DANIEL'S PROPOSAL. THAT WHAT I CAN SEE FROM THE DOCUMENTS. SO --

2512

MR. WADE: LET'S GO BACK TO MAKE SURE THAT WE'RE VERY CLEAR ON THIS. OKAY?

2514

MR. WADE: THIS IS AN IMPORTANT ISSUE. LET'S GO BACK TO PAGE 4. LET'S FOCUS ON THE BOTTOM EMAIL.

2516

MR. WADE: OKAY. LET'S LOOK AT THAT. THAT'S A FORWARD FROM YOU TO DR. YOUNG, MS. HOLMES, MR. BALWANI ON NOVEMBER 26TH, 2013; CORRECT?

2518

MR. WADE: IT'S THE FORWARD OF AN EMAIL THAT IS BELOW; CORRECT?

2519

ADAM ROSENDORFF: NO. THE EMAIL BELOW IS A NEW EMAIL.

2520

MR. WADE: WELL, LET'S LOOK AT -- LET'S NOW GO TO THE EMAIL BELOW. LET'S LOOK, LET'S LOOK AT THAT WHOLE PAGE. OKAY? THAT'S WHAT IS BEING FORWARDED TO THOSE PEOPLE IN 2013; CORRECT? THAT EMAIL THREAD THAT INCLUDED YOUR EMAIL TO DANIEL, YOUR RESPONSE TO DANIEL, WHICH IS SET FORTH DIRECTLY BELOW YOUR EMAIL THERE?

2521

ADAM ROSENDORFF: SO THE WAY I SEE THIS IS THAT THE ONLY THING THAT I FORWARDED TO ELIZABETH AND SUNNY WAS THE STATEMENT, "DANIEL, THANKS, I'LL WRITE UP THE SOP AND INCORPORATE WHAT WE HAVE DISCUSSED." I'M LOOKING AT THE NEXT ITEM AS A SEPARATE EMAIL.

2522

MR. WADE: AS NOT ENCAPSULATING EVERYTHING THAT'S BEFORE; RIGHT? YOU JUST SAID, THANKS, I'LL WRITE UP THE SOP WITHOUT INCLUDING THAT CONTENT? THAT'S YOUR TESTIMONY?

2523

ADAM ROSENDORFF: THAT'S HOW I READ -- THAT'S HOW I INTERPRET THIS DOCUMENT TODAY, YES.

2524

MR. WADE: OKAY. YOU'RE FAMILIAR WITH EMAIL THREADS?

2526

MR. WADE: OKAY. WELL, LET'S GO BACK UP THE CHAIN. YOU HAD CC'D MS. HOLMES. MS. HOLMES HAD BEEN CC'D. DO YOU RECALL THAT ON THE TOP OF PAGE 2?

2527

ADAM ROSENDORFF: THE TOP OF PAGE 2. THE BOTTOM OF PAGE 1 IS FROM SUNNY BALWANI TO DANIEL AND MYSELF AND LANGLY, ET CETERA, AND ELIZABETH.

2528

MR. WADE: RIGHT. AND HE SAYS, "CC'ING ELIZABETH ON THIS AS WE WENT THRU THESE DISCUSSIONS OVER A YEAR AGO."

2530

MR. WADE: DO YOU THINK THE DISCUSSIONS YOU WERE GOING THROUGH OVER A YEAR AGO WAS YOUR FORWARD ON THE SOP, OR DO YOU THINK IT WAS THE SUBSTANCE OF THE ISSUE?

2531

ADAM ROSENDORFF: I'M NOT FOLLOWING. I'M SORRY.

2532

MR. WADE: OKAY. LET'S KEEP GOING. MS. HOLMES THEN RESPONDS WITH RESPECT TO THAT ENTIRE DISCUSSION; CORRECT?

2534

MR. WADE: OKAY. AND THAT ENTIRE DISCUSSION RELATED TO THE PERFORMANCE OF PROFICIENCY TESTING ON EDISON DEVICES THAT WAS NOT CONSISTENT WITH THE AAP POLICY THAT YOU DRAFTED INTO THE SOP?

2536

MR. WADE: OKAY. AND THAT WAS THE DATA THAT WAS INCLUDED IN MS. CHEUNG'S EMAIL THAT THE GOVERNMENT SHOWED YOU ON DIRECT TESTIMONY?

2538

JUDGE DAVILA: MR. WADE, DO YOU --

2539

MR. WADE: IS IT 2:00? YEAH, NOW IS PROBABLY A GOOD TIME TO BREAK. I DON'T WANT TO HOLD THE DOCTOR UP. I KNOW HE HAS AN IMPORTANT --

2540

JUDGE DAVILA: SO LET'S TAKE OUR AFTERNOON RECESS, LADIES AND GENTLEMEN. LET'S TAKE 20 MINUTES, 20 MINUTES. WILL THAT DO? AND WE MAY HAVE A BREAK IN OUR WITNESSES. THE DOCTOR MAY NEED TO -- I THINK HE HAS AN APPOINTMENT. SO, DOCTOR, WE'LL EXCUSE YOU FOR THE REST OF THE DAY, AND WE'LL SEE YOU AGAIN FRIDAY MORNING, PLEASE, AT 9:00 O'CLOCK.

2541

ADAM ROSENDORFF: OKAY. VERY GOOD.

2542

JUDGE DAVILA: THANK YOU. COUNSEL, IF YOU COULD REMAIN FOR JUST A MOMENT.

2543

(JURY OUT AT 2:04 P.M.)

2544

JUDGE DAVILA: ALL RIGHT. THANK YOU. THE RECORD SHOULD REFLECT OUR JURY AND ALTERNATES HAVE LEFT THE COURTROOM FOR A BREAK. ALL COUNSEL AND MS. HOLMES IS PRESENT. WE'RE GOING TO COME BACK IN 20 MINUTES. WILL WE HAVE A WITNESS THEN, MR. LEACH?

2545

MR. LEACH: WE WILL, YOUR HONOR, YES.

2546

JUDGE DAVILA: GREAT. OKAY. THANK YOU. WE'LL BE IN RECESS THEN.

2547

COURT CLERK: COURT IS IN RECESS.

2548

(RECESS FROM 2:05 P.M. UNTIL 2:28 P.M.)

2549

(JURY IN AT 2:28 P.M.)

2550

JUDGE DAVILA: THANK YOU. WE'RE BACK ON THE RECORD. OUR JURY AND ALTERNATES ARE PRESENT. ALL COUNSEL ARE PRESENT AND MS. HOLMES IS PRESENT. AS I SAID, LADIES AND GENTLEMEN, WE'RE GOING TO TAKE A BREAK WITH DR. ROSENDORFF'S TESTIMONY AND WE'LL RESUME WITH HIM ON FRIDAY MORNING. BUT IN THE ALTERNATIVE, YOU HAVE A WITNESS TO CALL, MR. LEACH?

2551

MR. LEACH: WE DO, YOUR HONOR. THE UNITED STATES CALLS DR. VICTORIA SUNG.

2552

JUDGE DAVILA: ALL RIGHT. THANK YOU. GOOD AFTERNOON. IF YOU WOULD PLEASE COME FORWARD AND FACE OUR COURTROOM DEPUTY HERE. IF YOU WOULD RAISE YOUR RIGHT HAND, SHE HAS A QUESTION FOR YOU.

2553

(GOVERNMENT'S WITNESS, VICTORIA SUNG, WAS SWORN.)

2555

COURT CLERK: GO AHEAD AND TAKE THE STAND.

2556

JUDGE DAVILA: PLEASE HAVE A SEAT HERE AND MAKE YOURSELF COMFORTABLE. FEEL FREE TO ADJUST THAT CHAIR AND MICROPHONE. I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE. WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME AND THEN SPELL IT, PLEASE.

2557

ADAM ROSENDORFF: VICTORIA SUNG. V-I-C-T-O-R-I-A, S-U-N-G.

2558

JUDGE DAVILA: THANK YOU. COUNSEL.

2559

MR. LEACH: THANK YOU, YOUR HONOR.

← Day 12Rosendorff Raises Testing Concerns; Defense Tests His Account and Responsibility1 of 2Victoria Sung — Direct/Cross →