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Federal Criminal TrialtranscripttranscriptAdam Rosendorff — Redirect (Recall, Continued) - Day 16 - Federal Criminal TrialAdam Rosendorff resumed redirect testimony about Theranos test failures, proficiency testing, laboratory inspections, and limits on his authority as laboratory director.
John C. BosticLance A. WadeEdward J. DavilaAdam RosendorffMr. BosticAdam RosendorffMr. WadeJudge DavilaCourt Clerkredirect
5 pages·2 witnesses·2,417 lines
Adam Rosendorff resumed redirect testimony about Theranos test failures, proficiency testing, laboratory inspections, and limits on his authority as laboratory director.

REDIRECT EXAMINATION (RESUMED) BY MR. BOSTIC:

MR. BOSTIC: GOOD MORNING, DR. ROSENDORFF.

ADAM ROSENDORFF: GOOD MORNING, SIR.

MR. BOSTIC: DO YOU RECALL WHEN WE LEFT OFF YESTERDAY, WE HAD BEEN LOOKING AT SOME EMAILS REPORTING QUALITY CONTROL FAILURE FOR THE EDISON ANALYZERS?

ADAM ROSENDORFF: YES, FROM LANGLY GEE.

MR. BOSTIC: CORRECT. AND DO YOU RECALL LOOKING AT AN EMAIL WHERE ON A GIVEN DAY MORE THAN HALF OF THE EDISON ANALYZERS HAD FAILED QC?

MR. BOSTIC: WHEN IT CAME TO QUALITY CONTROLS PROBLEMS AT THERANOS, WERE THOSE PROBLEMS LIMITED TO THE HCG ASSAY?

MR. BOSTIC: I'D LIKE TO SHOW YOU EXHIBIT 13809, WHICH IS IN EVIDENCE. IF WE COULD PUBLISH THAT. DR. ROSENDORFF, DO YOU SEE IN FRONT OF YOU A THERANOS PRESENTATION ENTITLED QUALITY SYSTEMS PRESENTATION?

MR. BOSTIC: DO YOU RECALL REVIEWING THIS SLIDE DECK WITH MR. WADE DURING YOUR CROSS-EXAMINATION?

MR. BOSTIC: LET'S TURN TO WHAT I THINK IS PAGE 12 OF THIS EXHIBIT. AND, DR. ROSENDORFF, DO YOU SEE A SLIDE TITLED QUALITY CONTROL IN FRONT OF YOU?

MR. BOSTIC: WE'VE REVIEWED OTHER DOCUMENTS IN EVIDENCE DURING THIS TRIAL THAT SPEAK TO QUALITY CONTROL FAILURE RATES OF EDISON DEVICES; CORRECT?

MR. BOSTIC: AS LAB DIRECTOR AT THERANOS, DID YOU HAVE A GENERAL UNDERSTANDING OF HOW THE EDISONS PERFORMED ON QUALITY CONTROL?

MR. BOSTIC: WHEN IT COMES TO THE SPECIFIC NUMBERS DEPICTED IN THE EXHIBIT IN FRONT OF YOU, CAN YOU VOUCH FOR THOSE SPECIFIC NUMBERS?

ADAM ROSENDORFF: NO. MY RECOLLECTION IS NOT GOOD ENOUGH TO VOUCH FOR THOSE NUMBERS.

MR. BOSTIC: I'LL DRAW YOUR ATTENTION TO THE MIDDLE SECTION OF THAT GRAPH AND THE RIGHT MOST SECTION. THEY BOTH LIST QUALITY CONTROL PERFORMANCE FOR QUARTER 1 OF 2014; IS THAT RIGHT?

ADAM ROSENDORFF: THE -- YES, THE MIDDLE AND THE RIGHT, CORRECT.

MR. BOSTIC: THE MIDDLE SECTION SAYS Q1 PREDICATE. WHAT DOES PREDICATE MEAN IN THIS CONTEXT?

ADAM ROSENDORFF: THE FDA APPROVED INSTRUMENTS.

MR. BOSTIC: THE NON-THERANOS INSTRUMENTS?

MR. BOSTIC: WHAT ABOUT Q1 THERANOS? WHICH INSTRUMENTS WOULD THAT REFER TO?

ADAM ROSENDORFF: ALL OF THE THERANOS LABORATORY DEVELOPED TESTS.

MR. BOSTIC: WOULD THAT INCLUDE THE EDISONS?

MR. BOSTIC: WOULD IT ALSO INCLUDE, TO YOUR UNDERSTANDING, THE THERANOS MODIFIED THIRD PARTY DEVICES?

MR. BOSTIC: DO YOU SEE THAT UNDER EACH OF THOSE HEADINGS, THERE ARE FOUR BULLET POINTS?

MR. BOSTIC: I'LL DRAW YOUR ATTENTION TO THE THIRD BULLET POINT DOWN IN EACH OF THOSE. DO YOU SEE THAT THAT LISTS CONTROLS FAILED?

MR. BOSTIC: IS THAT REFERRING TO QUALITY CONTROL PERFORMANCE?

ADAM ROSENDORFF: I BELIEVE SO, YES.

MR. BOSTIC: UNDER PREDICATE, THIS CHART INDICATES THAT .75 PERCENT CONTROLS FAILED. DO YOU SEE THAT?

MR. BOSTIC: FOR THE THERANOS DEVICES IN CONTRAST, 2.9 PERCENT CONTROLS FAILED. DO YOU SEE THAT?

MR. BOSTIC: IN OTHER WORDS, THE THERANOS DEVICES FAILED CONTROLS MORE THAN THREE TIMES AS OFTEN AS THE NON-THERANOS DEVICES ACCORDING TO THIS?

ADAM ROSENDORFF: ACCORDING TO THIS, YES.

MR. BOSTIC: AND IS THAT GENERALLY CONSISTENT WITH YOUR RECOLLECTION OF HOW THOSE TWO GROUPS OF ANALYZERS PERFORMED?

ADAM ROSENDORFF: NO. THE MONTHLY QC FAILURE RATES I REVIEWED WITH LANGLY SHOWED A MUCH HIGHER PERCENTAGE CONTROL FAILURE.

MR. BOSTIC: FOR WHICH CATEGORY OF DEVICE?

ADAM ROSENDORFF: JUST, JUST -- I THINK IT WAS ACROSS ALL THE DEVICES, THE QC WAS SHOWING ACROSS ALL THE DEVICES.

MR. BOSTIC: HOW ABOUT WHEN IT COMES TO ANY DIFFERENCES IN PERFORMANCE BETWEEN THE THERANOS DEVICE QUALITY CONTROL PERFORMANCE AND THE UNMODIFIED DEVICE QUALITY CONTROL PERFORMANCE? DID YOU SEE A DIFFERENCE THERE AT THERANOS?

MR. BOSTIC: AND WHAT WAS THAT DIFFERENCE?

ADAM ROSENDORFF: THE QUALITY CONTROL FAILED MUCH MORE FREQUENTLY ON THE THERANOS DEVICES, OR LDT'S.

MR. BOSTIC: LET'S LOOK BRIEFLY AT PAGE 4 OF EXHIBIT 13809. DO YOU SEE, DR. ROSENDORFF, A SLIDE ENTITLED THERANOS LABORATORY LICENSURES?

MR. BOSTIC: THE THIRD BULLET DOWN MENTIONS CLIA ARIZONA. DO YOU SEE THAT?

MR. BOSTIC: DID THERANOS OPERATE A LAB IN ARIZONA DURING YOUR TIME AS LAB DIRECTOR?

MR. BOSTIC: THIS INDICATES THAT THE LICENSE WAS RECEIVED ON JUNE 24TH, 2014. DO YOU SEE THAT?

MR. BOSTIC: DID YOU HAVE AN UNDERSTANDING DURING YOUR TIME AT THE COMPANY OF WHAT KINDS OF TESTS WERE RUN IN THE ARIZONA LAB VERSUS IN THE CALIFORNIA LAB?

ADAM ROSENDORFF: MY UNDERSTANDING WAS ARIZONA WAS FDA APPROVED PREDICATE INSTRUMENTS ONLY.

MR. BOSTIC: SO IN OTHER WORDS, NO THERANOS SPECIFIC DEVICES IN THE ARIZONA LAB?

MR. BOSTIC: ON THAT SAME TOPIC OF LICENSES, YOU TESTIFIED THAT THERANOS HAD A CLIA LICENSE IN 2013 AT THE TIME OF THE LAUNCH; IS THAT CORRECT?

MR. BOSTIC: WHO ISSUED THAT CLIA LICENSE?

ADAM ROSENDORFF: LABORATORY FIELD SERVICES, STATE OF CALIFORNIA.

MR. BOSTIC: AND IS THERE AN AFFILIATION THERE WITH CMS?

ADAM ROSENDORFF: YES. LFS PERFORMANCE INSPECTIONS ISSUES LICENSURE ON BEHALF OF CMS.

MR. BOSTIC: AND DID THE GRANTING OF THAT LICENSE MEAN THAT EITHER CMS OR LFS HAD EVALUATED AND APPROVED THE EDISON DEVICE SPECIFICALLY?

MR. BOSTIC: OKAY. WE CAN TAKE THAT EXHIBIT DOWN. THANK YOU. I'D LIKE TO TALK BRIEFLY ABOUT A COUPLE OTHER ASSAYS OR ASSAY CATEGORIES THAT YOU DISCUSSED WITH MR. WADE. FIRST, DO YOU RECALL DISCUSSION YESTERDAY ABOUT A SPATE OF LOW HDL RESULTS THAT THE THERANOS TECHNOLOGY PRODUCED?

MR. BOSTIC: DO YOU RECALL A DISCUSSION OF THE STEPS THAT THERANOS TOOK TO TRY AND ADDRESS THAT ISSUE?

MR. BOSTIC: AND DO YOU RECALL THAT INCLUDING A DISCUSSION OF A STUDY COMPARING RESULTS BETWEEN TWO DIFFERENT ADVIA MACHINES?

MR. BOSTIC: OR AT LEAST MULTIPLE ADVIA MACHINES?

MR. BOSTIC: CAN YOU REMIND US, WHAT KIND OF DEVICE AT THERANOS WAS USED DURING THIS TIME TO TEST HDL?

ADAM ROSENDORFF: ADVIA 1800 MODIFIED FOR THE THERANOS LDT.

MR. BOSTIC: SO IT WAS A MODIFIED THIRD PARTY DEVICE NO LONGER IN THE FDA APPROVED CATEGORY?

ADAM ROSENDORFF: CORRECT. AS SOON AS YOU MAKE A MODIFICATION TO AN FDA APPROVED DEVICE, IT IMMEDIATELY BECOMES A LABORATORY DEVELOPED TEST.

MR. BOSTIC: YESTERDAY YOU MENTIONED THAT THAT STUDY SHOWED SOME VARIATION BETWEEN ADVIA INSTRUMENTS WHEN IT CAME TO HDL. DO YOU RECALL THAT?

MR. BOSTIC: DO YOU RECALL WHETHER THE SAMPLE TYPE, VEIN OR FINGERSTICK, HAD ANY EFFECT IN THAT STUDY ON THE LEVEL OF VARIATION BETWEEN THOSE DEVICES?

ADAM ROSENDORFF: YES, IT DID. THE VARIATION COMPARING VENOUS TO FINGERSTICK WAS MUCH MORE PRONOUNCED WHEN FINGERSTICK SAMPLES WERE ASSAYED ON EITHER INSTRUMENT. THERE'S DATA TO THAT EFFECT.

MR. BOSTIC: AND HOW DID THERANOS ACTUALLY TEST HDL IN THE LAB? WAS IT ON VEIN SAMPLES ON THE MODIFIED SIEMENS ADVIA OR DID THEY USE FINGERSTICK SAMPLES?

ADAM ROSENDORFF: FINGERSTICK.

MR. BOSTIC: DOES THAT MEAN THAT USING THE THERANOS APPROACH ON THESE DEVICES ACTUALLY MADE THE DEVICES PERFORM WORSE?

ADAM ROSENDORFF: YES. IT -- IT INCREASED THE, THE DIFFERENCES IN RESULTS BETWEEN INSTRUMENTS.

MR. BOSTIC: AND ARE THOSE KINDS OF DIFFERENCES AND RESULTS BETWEEN INSTRUMENTS SOMETHING THAT'S GOOD TO SEE IN A BLOOD TESTING LAB OR BAD?

MR. BOSTIC: MR. WADE SUGGESTED TO YOU ON CROSS-EXAMINATION THAT THE HDL PROBLEMS AT THERANOS WERE NOT THERANOS ASSAY PROBLEMS. DO YOU RECALL THAT?

ADAM ROSENDORFF: SORRY. I -- MR. WADE SUGGESTED THAT?

MR. BOSTIC: DO YOU RECALL A DISCUSSION ABOUT WHETHER THE HDL PROBLEMS AT THERANOS WERE THERANOS ASSAY PROBLEMS OR NOT?

MR. BOSTIC: WHAT WAS YOUR CONCLUSION AT THE TIME AS TO WHETHER THIS REPRESENTED A PROBLEM WITH THE ASSAY OR NOT?

ADAM ROSENDORFF: I THOUGHT THERE WAS A PROBLEM WITH THE ASSAY.

MR. BOSTIC: MR. WADE, ON CROSS-EXAMINATION, SAID, I THINK, THAT HE DIDN'T WANT TO HEAR YOUR ANALYSIS CURRENTLY. I WOULD, THOUGH. HOW DO YOU REACH THAT CONCLUSION THAT THE HDL ISSUES WERE PROBLEMS WITH THE THERANOS ASSAY?

ADAM ROSENDORFF: SO WE, WE DID A STUDY WITH MATCHED VENOUS AND FINGERSTICK WHERE THE RESULTS SHOULD BE VERY CLOSE TO EACH OTHER, COMPARING ON EACH INSTRUMENT JUST LOOKING FROM INSTRUMENT TO INSTRUMENT. THE VENOUS AND FINGERSTICK RESULT SHOULD BE PRETTY CLOSE, EVEN IF THERE ARE DIFFERENCES BETWEEN THE TWO INSTRUMENTS. IF YOU JUST LOOK AT ONE INSTRUMENT, THOSE RESULTS SHOULD MATCH PRETTY CLOSELY, AND THEY WEREN'T MATCHING. SO TO MY MIND, THAT INDICATED A PROBLEM WITH -- THAT THE ASSAY -- THE OTHER ISSUE WAS -- YEAH, I'LL JUST LEAVE IT THERE, YEAH.

MR. BOSTIC: I DON'T WANT TO CUT YOU OFF, THOUGH.

MR. BOSTIC: PLEASE COMPLETE YOUR ANSWER.

ADAM ROSENDORFF: THAT'S FINE, YEAH.

MR. BOSTIC: LET'S TALK NEXT ABOUT ISE ASSAYS. DO YOU RECALL A DISCUSSION ON CROSS-EXAMINATION ABOUT THAT CATEGORY?

MR. BOSTIC: IF WE COULD BRING UP, PLEASE, EXHIBIT 13893, WHICH IS IN EVIDENCE. DR. ROSENDORFF, DO YOU SEE AN EMAIL IN FRONT OF YOU THAT'S DATED MAY 24TH, 2014?

MR. BOSTIC: AND DO YOU RECALL DISCUSSING THIS EMAIL CHAIN ABOUT ISE'S WITH MR. WADE ON CROSS?

MR. BOSTIC: LET'S GO TO PAGE 2 OF THIS EMAIL, PLEASE. AND LET'S ZOOM IN ON THE -- SEE IF WE CAN CAPTURE ALL THAT TEXT IN DR. YOUNG'S EMAIL. AND, DR. ROSENDORFF, I WANT TO DRAW YOUR ATTENTION TO ABOUT HALFWAY DOWN THAT SELECTION WHERE IT SAYS "ADDITIONAL ISSUES THAT I PLAN TO HAVE THE TEAM ADDRESS." DO YOU SEE THAT?

MR. BOSTIC: THE BULLET POINT UNDER THAT SAYS "WE HAVE SEEN THAT DILUTED VENOUS SAMPLES HAVE MUCH BETTER PRECISION THAN DILUTED PCTN/CAPILLARY SAMPLES." DO YOU SEE THAT?

MR. BOSTIC: CAN YOU EXPLAIN IN PLAIN LANGUAGE WHAT THAT'S SAYING?

ADAM ROSENDORFF: SO JUST TO TRY TO EXPLAIN IT TO THE JURY, PRECISION MEANS WHEN YOU TAKE A SAMPLE AND YOU DO REPEATED MEASUREMENT OF IT AND YOU MAKE SURE THAT THE RESULT MATCHES EACH TIME YOU MEASURE. THAT'S WHAT PRECISION IS. SO DANIEL IS DOING PRECISION ON DILUTED VENOUS BLOOD, AND HE'S ALSO LOOKING AT PRECISION FOR THE -- FOR THIS -- WITH THESE ISE ASSAYS ON CAPILLARY SAMPLES AND HE'S SAYING THAT THE PRECISION IS MUCH BETTER WITH THE DILUTED VENOUS BLOOD THAN WITH THE CAPILLARY BLOOD SAMPLES.

MR. BOSTIC: IS CAPILLARY ANOTHER WAY TO DESCRIBE FINGERSTICK SAMPLES?

MR. BOSTIC: AND HOW DID THERANOS TEST ISE ANALYTES AT THIS TIME? WAS IT THROUGH VENOUS SAMPLES OR FINGERSTICK SAMPLES?

ADAM ROSENDORFF: FINGERSTICK.

MR. BOSTIC: THE KIND OF SAMPLE THAT WAS SHOWING HIGHER VARIABILITY; IS THAT RIGHT?

MR. BOSTIC: THE BULLET POINT DOWN TOWARDS THE BOTTOM OF THE SELECTION SAYS, "WE STARTED THIS WEEK MEASURING LITHIUM IN OUR PCTN/CAPILLARY SAMPLES" --

MR. BOSTIC: -- "TO ASSESS HEPARIN CONCENTRATIONS." DO YOU SEE THAT?

MR. BOSTIC: "INITIAL DATA SUGGEST A WIDE RANGE OF CONCENTRATIONS IN OUR CAPILLARY SAMPLES, AND POSSIBLY CONCENTRATIONS THAT ARE VERY HIGH." DO YOU SEE THAT?

MR. BOSTIC: AND HE SAYS THEY'RE CONTINUING TO WORK ON THAT; IS THAT RIGHT?

MR. BOSTIC: BASED ON THAT, WAS IT YOUR UNDERSTANDING, OR IS IT YOUR UNDERSTANDING THAT THE ISE ISSUES AT THERANOS WERE SOLVED AT THIS TIME, OR WAS THERE MORE WORK TO BE DONE?

ADAM ROSENDORFF: MORE WORK TO BE DONE.

MR. BOSTIC: WHEN IT COMES TO DIFFERENCES IN BEHAVIOR BETWEEN FINGERSTICK SAMPLES AND VEIN SAMPLES, WAS THAT A RECURRING SOURCE OF DIFFICULTY OR PROBLEMS AT THERANOS?

MR. BOSTIC: OKAY. WE CAN PUT THAT EXHIBIT ASIDE. THANK YOU. I'D LIKE TO TALK BRIEFLY ABOUT THE BICARBONATE ASSAY. DO YOU REMEMBER DISCUSSING THAT WITH MR. WADE?

MR. BOSTIC: DO YOU RECALL A DISCUSSION OF A STUDY THAT DANIEL YOUNG WAS DOING TO TRY AND ADDRESS PROBLEMS THAT THERANOS WAS HAVING WITH THE BICARBONATE TEST?

ADAM ROSENDORFF: I DON'T RECALL THAT SPECIFICALLY.

MR. BOSTIC: ARE YOU GENERALLY -- LET ME START AGAIN. DURING YOUR TIME AT THERANOS, WERE YOU GENERALLY AWARE OF STUDIES THAT DR. YOUNG WOULD CONDUCT TO TRY TO ADDRESS ACCURACY AND RELIABILITY PROBLEMS THAT POPPED UP WITH THERANOS TESTS?

ADAM ROSENDORFF: YES, CONTINUALLY.

MR. BOSTIC: THAT WAS A COMMON OCCURRENCE OR SITUATION AT THERANOS?

ADAM ROSENDORFF: VERY COMMON, YES.

MR. BOSTIC: AS A WHOLE, DID DR. YOUNG'S STUDIES GIVE YOU ANY REASON TO DOUBT YOUR ULTIMATE DECISION TO LEAVE THE COMPANY IN 2014?

MR. BOSTIC: WHY NOT?

ADAM ROSENDORFF: FREQUENTLY THE TROUBLESHOOTING WOULD BE DONE ON VENOUS BLOOD, DILUTED VENOUS BLOOD, WHEREAS ACTUAL PATIENT SAMPLES WAS CAPILLARY BLOOD COLLECTED IN CTN. SO THE TROUBLESHOOTING DIDN'T CAPTURE ISSUES WITH BLOOD COLLECTION. NOT TO BE TOO CRITICAL, BUT AT TIMES I DIDN'T FULLY TRUST THE DATA THAT WAS COMING OUT OF R&D FOR TROUBLESHOOTING. EVEN AFTER THE SO-CALLED FIXES, I WAS STILL SEEING ANOMALIES IN THE RESULTS, TOO MANY COMING OUT HIGH OR LOW, NOT MATCHING UP WITH OTHER REFERENCE LABORATORIES, ET CETERA.

MR. BOSTIC: AND ARE YOU REFERRING TO --

MR. WADE: YOUR HONOR, I MOVE TO STRIKE THAT LAST ANSWER.

MR. BOSTIC: I THINK IT'S DIRECTLY RESPONSIVE, YOUR HONOR.

JUDGE DAVILA: OVERRULED.

BY MR. BOSTIC:

MR. BOSTIC: DR. ROSENDORFF, WHEN YOU SAY THAT YOU SAW CONTINUED PROBLEMS NOT MATCHING UP TO REFERENCE LABS -- IS THAT WHAT YOU JUST SAID?

MR. BOSTIC: ARE YOU REFERRING TO RESULTS THAT YOU SAW FROM PATIENT TESTING AT THERANOS?

MR. BOSTIC: I'D LIKE TO SHIFT GEARS AND TALK ABOUT THE TIMING OF WHEN THERANOS BEGAN OFFERING ITS TESTING SERVICES. DO YOU RECALL SOME DISCUSSION ON CROSS-EXAMINATION ABOUT WHEN THERANOS ACTUALLY LAUNCHED ITS SERVICES?

MR. BOSTIC: DURING YOUR DIRECT EXAMINATION, WE TALKED ABOUT A DATE THAT WAS IN YOUR MIND IN THE FIRST PART OF SEPTEMBER. DO YOU RECALL THAT?

MR. BOSTIC: AND THERE WAS A QUESTION ABOUT, OR A SERIES OF QUESTIONS FROM MR. WADE ABOUT WHETHER THAT WAS A TRUE LAUNCH OR A SOFT LAUNCH I THINK HE SAID. DO YOU RECALL THAT DISCUSSION?

MR. BOSTIC: I'D LIKE YOU TO LOOK AT EXHIBIT 5407, WHICH IS IN EVIDENCE. IF WE COULD PUBLISH THAT, AND IF WE COULD ZOOM IN ON THE BOTTOM HALF OF THIS PAGE, PLEASE. OKAY. DR. ROSENDORFF, YOU ARE NOT ON THIS EMAIL; CORRECT?

MR. BOSTIC: DO YOU SEE AN EMAIL AT THE TOP OF THAT SELECTION FROM ELIZABETH HOLMES TO JIM, AND IT'S ADDRESSED TO GENERAL MATTIS?

MR. BOSTIC: AND THE DATE IS SEPTEMBER 7TH, 2013; CORRECT?

MR. BOSTIC: TWO DAYS BEFORE THE SEPTEMBER 9TH DATE THAT YOU IDENTIFIED?

MR. BOSTIC: AND MS. HOLMES SAYS IN HER EMAIL, "GENERAL MATTIS, FYI, THE BELOW WILL GO OUT TO OUR SHAREHOLDERS TONIGHT. WE HAVE BEGUN THE LAUNCH." DO YOU SEE THAT?

MR. BOSTIC: BELOW THAT, THERE'S A MESSAGE FROM MS. HOLMES APPARENTLY TO THERANOS SHAREHOLDERS. DO YOU SEE THAT?

MR. BOSTIC: AND THAT MESSAGE SAYS, "TO OUR SHAREHOLDERS, I AM DELIGHTED TO SHARE THAT WE HAVE NOW BEGUN THE COMMERCIAL LAUNCH OF THE NEW PRODUCTS AND SERVICES WE'VE BEEN WORKING ON FOR THE PAST YEARS." DO YOU SEE THAT?

MR. BOSTIC: DO YOU SEE ANY MENTION OF A SOFT LAUNCH IN THIS MESSAGE?

MR. BOSTIC: I'D LIKE TO SHOW YOU WHAT WE'VE MARKED AS EXHIBIT 1113, AND I'M HANDING A COPY OF THAT TO THE COURT, AS WELL AS THE NEXT FEW EXHIBITS THAT I'D LIKE TO INTRODUCE (HANDING). THESE HAVE BEEN PROVIDED TO THE DEFENSE ALREADY. MAY I APPROACH THE WITNESS, YOUR HONOR?

MR. BOSTIC: (HANDING.)

BY MR. BOSTIC:

MR. BOSTIC: DR. ROSENDORFF, DO YOU HAVE EXHIBIT 1113 IN FRONT OF YOU?

MR. BOSTIC: OKAY. AND I'LL GIVE YOU A SECOND TO LOOK IT OVER, BUT CAN YOU TELL ME GENERALLY WHAT IT IS?

ADAM ROSENDORFF: IT APPEARS TO BE A PRESS RELEASE THAT'S DATED SEPTEMBER 9TH, 2013. IT APPEARS TO BE A JOINT PRESS RELEASE BETWEEN THERANOS AND WALGREENS, AND STATING THAT THERANOS IS NOW ABLE TO --

MR. BOSTIC: AND ACTUALLY, BEFORE YOU GET INTO THE CONTENTS, APOLOGIES.

ADAM ROSENDORFF: OH, I'M SORRY.

MR. BOSTIC: IS IT GENERALLY ON THE LAUNCH OF TESTING SERVICES?

MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 1113.

MR. WADE: NO OBJECTION, YOUR HONOR.

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

(GOVERNMENT'S EXHIBIT 1113 WAS ADMITTED IN EVIDENCE.)

BY MR. BOSTIC:

MR. BOSTIC: AND, DR. ROSENDORFF, DO YOU SEE THAT AT THE TOP OF THAT PAGE, THIS IS A PRESS RELEASE DATED SEPTEMBER 9TH, 2013?

MR. BOSTIC: THAT SEPTEMBER 9TH DATE, IS THAT THE DATE THAT YOU RECALLED AS BEING THE LAUNCH DATE?

MR. BOSTIC: THAT FIRST PARAGRAPH READS, "THERANOS, INCORPORATED AND WALGREENS TODAY ANNOUNCED A LONG-TERM PARTNERSHIP TO BRING ACCESS TO THERANOS'S NEW LAB TESTING SERVICE THROUGH WALGREENS PHARMACIES NATIONWIDE." DO YOU SEE THAT?

MR. BOSTIC: IT SAYS, "AS THE SERVICE BECOMES AVAILABLE THROUGH THERANOS WELLNESS CENTERS INSIDE WALGREENS STORES, CONSUMERS WILL BE ABLE TO ACCESS LESS INVASIVE AND MORE AFFORDABLE CLINICIAN-DIRECTED LAB TESTING, FROM A BLOOD SAMPLE AS SMALL AS A FEW DROPS, OR 1/1000 THE SIZE OF A TYPICAL BLOOD DRAW." DO YOU SEE THAT?

MR. BOSTIC: THERE'S SOME MENTION OF A FINGERSTICK METHOD OR MICRO-SAMPLE. DO YOU SEE THAT IN THE REMAINDER OF THAT PARAGRAPH?

MR. BOSTIC: AND I'LL DRAW YOUR ATTENTION TO THE BOTTOM PARAGRAPH IN THIS PAGE. DO YOU SEE THAT THE SECOND SENTENCE OF THE THIRD PARAGRAPH SAYS, "THERANOS'S PROPRIETARY LABORATORY INFRASTRUCTURE MINIMIZES HUMAN ERROR THROUGH EXTENSIVE AUTOMATION TO PRODUCE HIGH QUALITY RESULTS." DO YOU SEE THAT?

MR. BOSTIC: ANYWHERE IN THIS PRESS RELEASE DO YOU SEE THE PHRASE "SOFT LAUNCH"?

MR. BOSTIC: OKAY. WE CAN PUT THAT EXHIBIT ASIDE. THE PHRASE "SOFT LAUNCH," IS THAT A MEDICAL TERM IN YOUR EXPERIENCE?

MR. BOSTIC: IS THE PHRASE "SOFT LAUNCH" A TERM FROM CLINICAL LABORATORY TESTING?

MR. BOSTIC: DO YOU RECALL THAT YOU DISCUSSED WITH MR. WADE ON A FEW OCCASIONS THE CLIA REGULATIONS AND HOW THEY GOVERN CLINICAL LAB TESTING?

MR. BOSTIC: TO YOUR KNOWLEDGE, DO THOSE CLIA REGULATIONS PROVIDE ANY SPECIAL, MORE RELAXED RULES FOR SOMETHING CALLED A SOFT LAUNCH?

MR. BOSTIC: DURING YOUR CROSS, THERE WAS SOME DISCUSSION ABOUT THE OVERALL TESTING VOLUME IN THE DAYS FOLLOWING SEPTEMBER 9TH. DO YOU RECALL THAT?

MR. BOSTIC: THERE WAS A SUGGESTION THAT THE OVERALL TESTING VOLUME MIGHT HAVE BEEN RELATIVELY LOW. DO YOU RECALL DISCUSSING THAT?

MR. BOSTIC: DO YOU HAVE PERSONAL KNOWLEDGE OF THAT? IN OTHER WORDS, ARE YOU ABLE TO TESTIFY ONE WAY OR ANOTHER ABOUT THE ACTUAL NUMBER OF TESTS THAT THERANOS WAS RUNNING DURING THAT TIME PERIOD?

MR. BOSTIC: ASSUMING THAT THE OVERALL TEST VOLUME WAS LOW DURING THE INITIAL WEEKS FOLLOWING THAT LAUNCH DATE, WOULD THAT ELIMINATE YOUR CONCERNS ABOUT ACCURACY PROBLEMS THAT THERANOS WAS SEEING AT THAT TIME?

MR. BOSTIC: WHY NOT?

ADAM ROSENDORFF: IT -- SO IF YOU -- WHILE IT'S TRUE, IF YOU HAVE ACCURACY PROBLEMS, YOU'RE GOING TO SEE MORE THE MORE TESTS THAT YOU RUN. THAT'S JUST -- IF IT'S A FIXED PERCENTAGE OF TESTS THAT ARE INACCURATE, YOU'RE GOING TO GET MORE INACCURATE TESTS THE MORE TESTS YOU RUN. BUT IN MY MIND, EVEN TESTING ONE PATIENT WITH A HIGH PROBABILITY OF INACCURACY WAS HIGHLY PROBLEMATIC FOR ME.

MR. BOSTIC: DO YOU RECALL THAT SOME OF THE INCIDENTS WE REVIEWED DURING YOUR DIRECT EXAMINATION RELATED TO INACCURATE TEST RESULTS THAT WERE RELEASED BY THERANOS?

MR. BOSTIC: ASSUMING THAT THE OVERALL TEST VOLUME WAS LOW DURING THAT TIME PERIOD --

MR. BOSTIC: -- DOES THAT HAVE ANY EFFECT ON THE SIGNIFICANCE OF INDIVIDUAL INACCURATE TEST RESULTS?

MR. BOSTIC: HOW ABOUT WHEN YOU PUT THOSE RESULTS INTO CONTEXT AND TRY TO DETERMINE HOW SERIOUS A RED FLAG THEY ARE? DOES IT MATTER HOW MANY TESTS THE LAB IS PERFORMING IN THE BACKGROUND? LET ME ASK A BETTER QUESTION. IF YOU SEE -- I'LL GIVE YOU A HYPOTHETICAL. IF YOU SEE 5 INACCURATE TEST RESULTS OUT OF A TOTAL OF 10,000 TESTS THAT A LAB DID DURING A CERTAIN TIME PERIOD --

MR. BOSTIC: -- VERSUS SEEING 5 INACCURATE TEST RESULTS OUT OF A TOTAL OF 50 --

MR. BOSTIC: -- RESULTS THAT A LAB DID DURING A CERTAIN TIME PERIOD, DO THOSE TWO SITUATIONS CAUSE YOU TO HAVE DIFFERENT VIEWS ABOUT THE LAB'S OVERALL PERFORMANCE?

MR. BOSTIC: CAN YOU EXPLAIN WHY?

ADAM ROSENDORFF: IF THERE ARE 5 INACCURATE TESTS OUT OF 50, THAT'S A 10 PERCENT FAILURE RATE, FOR WANT OF A BETTER TERM. IF IT'S 5 OUT OF 50,000, IT'S A MUCH LOWER RATE OF FAILURE. SO ANY ANALYTIC SYSTEM WILL GIVE YOU FAILURES, BUT YOU -- SO IT'S REALLY IMPORTANT TO TRACK THE SCALE AND THE PERIOD OF TIME TABLES THAT YOU'RE SEEING.

MR. BOSTIC: ASSUMING THAT THERE WAS A RELATIVELY LOW TEST VALUE IN THE DAYS FOLLOWING THE LAUNCH AT THERANOS --

MR. BOSTIC: -- WERE YOU SATISFIED WITH THE NUMBER OF INACCURATE TEST RESULTS THAT YOU WERE SEEING AT THE TIME?

MR. BOSTIC: SPEAKING OF TESTING VOLUME, DO YOU RECALL YOUR PREVIOUS TESTIMONY THAT YOU REVIEWED AT A DEPOSITION WHERE YOU COMPARED THE NUMBER OF COMPLAINTS YOU RECEIVED AT THERANOS TO WHAT YOU SAW AT UNIVERSITY OF PITTSBURGH?

MR. BOSTIC: JUST SO THE RECORD IS CLEAR, WERE YOU TROUBLED BY THE NUMBER OF DOCTOR AND PATIENT COMPLAINTS THAT YOU SAW COME IN THE DOOR AT THERANOS?

MR. BOSTIC: BY THE WAY, DID YOU KNOW ABOUT EACH AND EVERY DOCTOR OR PATIENT COMPLAINT THAT CAME IN TO THE COMPANY DURING YOUR TIME AS LAB DIRECTOR?

MR. BOSTIC: THE ONES YOU SAW STILL TROUBLED YOU?

MR. BOSTIC: WAS THE LEVEL OF COMPLAINTS THAT YOU SAW AT UNIVERSITY OF PITTSBURGH EQUALLY TROUBLING TO YOU?

MR. BOSTIC: WHY NOT? WHY WERE THOSE TWO SITUATIONS DIFFERENT?

ADAM ROSENDORFF: SO AT THE UNIVERSITY OF PITTSBURGH, THE DISCUSSIONS WITH THE PHYSICIANS WERE FREQUENTLY ABOUT WHAT TEST METHOD WE SHOULD USE. I REMEMBER FREQUENT CONVERSATIONS WITH THE ENDOCRINOLOGISTS ABOUT HORMONES THAT WERE PRESENT IN VERY LOW LEVELS THAT CAN BE TRICKY TO TEST ACCURATELY AND WHAT THE BEST METHOD SHOULD BE. THERE WERE A COUPLE OF COMPLAINTS, I REMEMBER ONE WAS ABOUT A VERY HIGH PHOSPHOROUS. IT HAD TO DO WITH A NURSE DRAWING BLOOD FROM A CENTRAL CATHETER INSTEAD OF FROM THE ARM. THE COMPLAINTS WERE NOT ABOUT TEST ACCURACY, PER SE. THEY WERE ABOUT -- THEY WERE COMPLAINTS ABOUT RESULTS, OCCASIONAL FLIERS, RESULTS THAT DIDN'T MAKE SENSE. BUT IT WAS NOT -- NONE OF THE CLINICIANS WERE QUESTIONING THE ACCURACY OF THE LABORATORY.

MR. BOSTIC: I'D LIKE TO SHIFT GEARS AND TALK ABOUT PROFICIENCY TESTING. ON DIRECT, YOU TESTIFIED ABOUT THE LACK OF PROFICIENCY TESTING AT THERANOS. DO YOU RECALL THAT?

MR. BOSTIC: THERE WAS, HOWEVER, SOME PROFICIENCY TESTING AT THE COMPANY; ISN'T THAT RIGHT?

MR. BOSTIC: ON WHAT DEVICES DID THERANOS CONDUCT REGULAR PROFICIENCY TESTING WHEN YOU WERE AT THE COMPANY?

ADAM ROSENDORFF: THE -- THE ONLY PROFICIENCY TESTING DATA THAT I CAN RECALL BEING RUN ACCORDING TO THE AAP WAS FOR VITAMIN D, I BELIEVE.

MR. BOSTIC: AND FOR NOW I'M ASKING YOU A BROADER QUESTION, NOT JUST ABOUT AAP, BUT PROFICIENCY TESTING IN GENERAL. DO YOU RECALL STANDARD PROFICIENCY TESTING OCCURRING AT THERANOS?

MR. BOSTIC: ON FDA APPROVED DEVICES?

MR. BOSTIC: WOULD THAT BE THE NON-THERANOS AND NON-THERANOS MODIFIED DEVICES?

MR. BOSTIC: WHEN YOU ANSWERED ON DIRECT THAT THERE WAS NO PROFICIENCY TESTING AT THERANOS, WAS THERE SOMETHING THAT WAS CONFUSING YOU AT THAT TIME THAT CAUSED YOU TO GIVE THAT ANSWER?

ADAM ROSENDORFF: I, I WANTED TO CLARIFY THAT EVEN THOUGH I HAD WRITTEN AN SOP OR AAP, BUT IT WASN'T BEING IMPLEMENTED ACROSS ALL OF THE ASSAYS.

MR. BOSTIC: OUR CONVERSATION DURING DIRECT, DID IT FOCUS MORE ON THE THERANOS SPECIFIC DEVICES OR THE UNMODIFIED FDA APPROVED DEVICES?

ADAM ROSENDORFF: I ASSUMED YOU WERE TALKING ABOUT THE THERANOS DEVICES, YES.

MR. BOSTIC: HOW ABOUT YOUR CONCERNS WHEN IT CAME TO TESTING ACCURACY? DID THOSE CONCERNS RELATE MOSTLY TO THE THERANOS SPECIFIC DEVICES OR THE UNMODIFIED THIRD PARTY DEVICES?

ADAM ROSENDORFF: THERANOS SPECIFIC DEVICES.

MR. BOSTIC: OKAY. I'D LIKE TO SHOW YOU BRIEFLY EXHIBIT 10029, WHICH IS IN EVIDENCE. AND IF WE COULD ZOOM IN JUST ON THE TOP PART OF THE PAGE. DR. ROSENDORFF, DO YOU SEE A COMPARATIVE EVALUATION REPORT FROM THE AMERICAN PROFICIENCY INSTITUTE?

MR. BOSTIC: DO YOU RECALL REVIEWING THIS DOCUMENT WITH MR. WADE DURING CROSS-EXAMINATION?

MR. BOSTIC: I'LL ASK YOU TO TAKE A LOOK AT THIS PAGE. FIRST OF ALL, THIS IS DATED 2014. DO YOU SEE THAT IN THE TOP LEFT?

MR. BOSTIC: THE PROFICIENCY TESTING RESULTS THAT ARE REPORTED IN THIS EXHIBIT, ARE THEY A RESULT OF PROFICIENCY TESTING ON THE THERANOS EDISON DEVICE?

MR. BOSTIC: WHAT DEVICE OR WHAT CATEGORY OF DEVICES IS REFLECTED IN THIS PROFICIENCY TESTING DATA?

ADAM ROSENDORFF: THESE ARE IMMUNOASSAYS AS INDICATED ON THE, ON THE REPORT, OR EVALUATION. THEY WERE RUN ON THE SIEMENS IMMULITE 2000 WITH IMMULITE REAGENT.

MR. BOSTIC: AND SO WOULD THAT HAVE BEEN AN UNMODIFIED, NON-THERANOS, FDA APPROVED TESTING METHOD?

MR. BOSTIC: IF WE COULD ZOOM OUT. DR. ROSENDORFF, LET ME KNOW IF THE TEXT IS TOO SMALL AND WE CAN ZOOM BACK IN, BUT LOOKING AT THE ACTUAL ASSAYS INVOLVED HERE, WERE ANY OF THESE ASSAYS RUN ON THE EDISON AT THERANOS?

ADAM ROSENDORFF: YES, ON -- YES, I BELIEVE ON PROLACTIN, PSA, TESTOSTERONE, ESTRADIOL, FSH. THOSE ARE THE ONES THAT I CAN RECALL.

MR. BOSTIC: AND ACTUALLY, I SHOULD HAVE ASKED YOU, WERE ANY OF THOSE ASSAYS RUN ON EITHER THE EDISON OR THE THERANOS MODIFIED THIRD PARTY DEVICES? WOULD THAT CHANGE YOUR ANSWER?

ADAM ROSENDORFF: THEY WERE RUN ON THE EDISON. THERE WAS ALSO -- I SHOULD SAY, THERE WAS ALSO AN ATTEMPT TO RUN DILUTED FINGERSTICK SAMPLES ON THE IMMULITE. I DON'T RECALL WHETHER THAT WAS ACTUALLY IMPLEMENTED FOR PATIENTS OR NOT.

MR. BOSTIC: OKAY. UNDERSTOOD. IN 2013 -- OR SORRY. IN 2014, WERE SOME OF THESE ASSAYS BEING RUN ON THERANOS SPECIFIC DEVICES OR THERANOS MODIFIED DEVICES?

ADAM ROSENDORFF: SOME OF THEM WERE BEING RUN ON THERANOS SPECIFIC DEVICES AND OTHERS ON -- I'M SORRY. SOME OF THEM WERE RUN ON FDA APPROVED DEVICES AND SOME OF THEM ON THE EDISONS.

MR. BOSTIC: DO YOU HAVE AN UNDERSTANDING THEN AS TO WHY, FOR PROFICIENCY TESTING, THE PROFICIENCY TESTING WOULD HAVE BEEN DONE USING THE UNMODIFIED THIRD PARTY DEVICES?

ADAM ROSENDORFF: I DID NOT THINK THAT THIS WAS APPROPRIATE GIVEN THE FACT THAT THE REGULATIONS STATE THAT YOU'RE SUPPOSED TO DO PROFICIENCY TESTING ON YOUR MOST COMMONLY USED METHOD. IN MANY CASES, WE WERE NOT USING THE IMMULITE FOR A NUMBER OF THESE ANALYTES. I SENT AN E-MAIL LISTING THE ANALYTES FOR WHICH WE SHOULD STOP THE CMS REPORTING BECAUSE CMS WAS UNDER THE IMPRESSION THAT WE WERE STILL USING THE FDA DEVICES AS THE PREDOMINANT DEVICES.

MR. BOSTIC: WE SAW THAT EMAIL DURING YOUR CROSS-EXAMINATION. IS THAT THE ONE YOU'RE REFERRING TO?

MR. BOSTIC: OKAY. WE CAN TAKE THAT EXHIBIT DOWN. THANK YOU. AS TO THE EDISON AND THE MODIFIED THIRD PARTY DEVICES, BASED ON WHAT YOU SAW AT THERANOS, WAS THERE EVER REGULAR PROFICIENCY TESTING ACTUALLY IMPLEMENTED FOR THOSE KINDS OF TESTS?

MR. BOSTIC: ON CROSS-EXAMINATION, YOU WERE SHOWN AN SOP RELATING TO THAT KIND OF PROFICIENCY TESTING ON THOSE DEVICES. DO YOU RECALL THAT?

MR. BOSTIC: IS THERE A DIFFERENCE IN A LAB BETWEEN HAVING A WRITTEN SOP AND ACTUALLY IMPLEMENTING OR CARRYING OUT THAT SOP?

ADAM ROSENDORFF: YES, HUGE DIFFERENCE.

MR. BOSTIC: ON CROSS-EXAMINATION, YOU ALSO SAW THAT PROFICIENCY TESTING AND AAP REMAINED A SUBJECT OF DISCUSSION THROUGHOUT YOUR TIME AT THE COMPANY; IS THAT CORRECT?

MR. BOSTIC: DID ANY OF THAT DISCUSSION REFRESH YOUR RECOLLECTION THAT THERE WAS PROFICIENCY TESTING ON THOSE METHODS THAT YOU HAD FORGOTTEN ABOUT, FOR EXAMPLE?

ADAM ROSENDORFF: SO R&D WAS DOING WHAT THEY WERE CALLING IQP. I NEVER SAW OR APPROVED THE PROCEDURE FOR IQP. THEY WERE DOING THEIR OWN THING.

MR. BOSTIC: I THINK WE'RE ABOUT TO LOOK AT SOME RELEVANT EXHIBITS FOR THAT. LET'S TAKE A QUICK LOOK AT EXHIBIT 2009 FIRST. AND THIS IS IN EVIDENCE. DR. ROSENDORFF, DO YOU SEE EXHIBIT 2009 IS AN EMAIL CHAIN FROM EARLY OCTOBER 2014?

MR. BOSTIC: AND DO YOU RECALL DISCUSSING THIS EMAIL CHAIN AND THESE CIRCUMSTANCES DURING YOUR TESTIMONY?

MR. BOSTIC: LET'S LOOK NEXT AT EXHIBIT 7482, WHICH IS ALSO IN EVIDENCE. AND LET'S GO TO THE NEXT PAGE. AND, DR. ROSENDORFF, DO YOU SEE THAT THIS IS A CONTINUED EMAIL DISCUSSION ABOUT, I BELIEVE, TESTOSTERONE RESULTS?

MR. BOSTIC: IF WE COULD ZOOM ON THE BOTTOM HALF OF THIS PAGE, PLEASE. DO YOU RECALL REVIEWING THIS EMAIL DURING YOUR CROSS-EXAMINATION WHERE YOU SAY, PLEASE LET CHRISTIAN HANDLE THE COMMUNICATION WITH THE DOCTOR?

MR. BOSTIC: DURING DIRECT, WE SPOKE ABOUT CHRISTIAN HOLMES'S ROLE IN DEALING WITH INQUIRIES FROM PATIENTS AND DOCTORS. DO YOU RECALL THAT?

MR. BOSTIC: GENERALLY SPEAKING, WHAT WAS YOUR POSITION ON THE WAY THAT CHRISTIAN HOLMES WAS INVOLVED IN SPEAKING WITH DOCTORS AND PATIENTS AT THERANOS?

ADAM ROSENDORFF: I KNOW THAT CHRISTIAN WAS A MIDDLEMAN, INTERMEDIARY BETWEEN CUSTOMER SERVICE OR THE REMOTE SITE IN ARIZONA AND MYSELF. SO HE WOULD BE RECEIVING THESE QUERIES AND COMPLAINTS. AND I DON'T KNOW WHAT WOULD -- WHAT -- IN HIS MIND, I DON'T KNOW WHAT DETERMINED WHAT SHOULD BE ESCALATED TO ME OR WHAT HE COULD HANDLE HIMSELF OR HE WOULD BE HANDLING THROUGH DANIEL. I ASSUMED THAT IF THERE WERE MEDICAL ISSUES AT PLAY, HE WOULD BE FORWARDING THOSE TO ME.

MR. BOSTIC: DID MR. HOLMES'S INVOLVEMENT IN THIS AREA HAVE AN EFFECT, IN YOUR MIND, ON YOUR COMMUNICATIONS WITH DOCTORS AND PATIENTS?

ADAM ROSENDORFF: I -- I GUESS I WASN'T CLEAR ON WHAT CHRISTIAN HAD ALREADY COMMUNICATED TO DOCTORS ON MANY OCCASIONS.

MR. BOSTIC: YOU TESTIFIED ON DIRECT ABOUT PRESSURE THAT YOU FELT IN CONNECTION WITH YOUR COMMUNICATIONS WITH DOCTORS AND PATIENTS. DO YOU RECALL THAT TESTIMONY?

MR. BOSTIC: WAS CHRISTIAN HOLMES PART OF THAT PRESSURE?

MR. BOSTIC: WHY IN THIS CASE, IN OCTOBER 2014, DID YOU EXPRESS A PREFERENCE FOR CHRISTIAN TO HANDLE THIS PARTICULAR COMMUNICATION WITH THAT DOCTOR?

ADAM ROSENDORFF: IN ORDER TO TALK HONESTLY AND TRANSPARENTLY WITH THE DOCTOR, I NEEDED MORE INFORMATION FROM THE ELISA GROUP ON THAT PARTICULAR ASSAY AND THAT RUN, ET CETERA. I DID NOT RECEIVE THAT, SO I DIDN'T FEEL LIKE I WAS EQUIPPED TO ADDRESS THE ISSUES WITH THE DOCTOR.

MR. BOSTIC: LET'S GO TO PAGE 1 OF THIS EXHIBIT, AND LET'S ZOOM IN ON THE TOP HALF OF THIS PAGE. DR. ROSENDORFF, DO YOU RECALL REVIEWING THIS PORTION OF THE EMAIL WITH MR. WADE?

MR. BOSTIC: FIRST OF ALL, THIS IS AN EMAIL FROM SUNNY BALWANI TO YOU CC'ING ELIZABETH HOLMES. DO YOU SEE THAT?

MR. BOSTIC: OR RATHER BCC'ING ELIZABETH HOLMES. DO YOU SEE THAT?

MR. BOSTIC: HIS EMAIL SAYS THAT WE ARE IN THE PROCESS OF RESPONDING TO THE DOCTOR, BUT HE WANTS TO SHARE WITH YOU A FEW THOUGHTS. UNDER NUMBER 1 HERE, MR. BALWANI SAYS THE SPURIOUS RESULT IN ALL LIKELIHOOD SEEMS TO BE DUE TO HEMOLYSIS. DO YOU SEE THAT?

MR. BOSTIC: CAN YOU REMIND US WHAT HEMOLYSIS IS?

ADAM ROSENDORFF: HEMOLYSIS IS BREAKING OPEN OF RED BLOOD CELLS WITHIN THE SAMPLE BEFORE IT'S TESTED.

MR. BOSTIC: AND WAS THAT A RECURRING SOURCE OF ISSUES AT THERANOS IN YOUR EXPERIENCE?

MR. BOSTIC: WAS THAT PROBLEM MORE OR LESS COMMON WITH FINGERSTICK SAMPLES AS OPPOSED TO VEIN SAMPLES?

ADAM ROSENDORFF: MUCH, MUCH MORE COMMON WITH FINGERSTICK.

MR. BOSTIC: ALL RIGHT. NUMBER 2 IN MR. BALWANI'S LIST HERE SAYS, "WE ARE DOING MONTHLY (MOST CASES WEEKLY) IQP (AAP) FOR EACH ASSAY ON EDISON AND OTHER DEVICES DOWNSTAIRS." DO YOU SEE THAT?

MR. BOSTIC: DID YOU AGREE WITH THAT STATEMENT?

MR. BOSTIC: WHY NOT?

ADAM ROSENDORFF: I NEVER -- SO AS I'VE TESTIFIED, THERE WAS NOT A FORMAL IQP POLICY OR SOP. I DID NOT VIEW IQP AND AAP AS INTERCHANGEABLE. AND I DID NOT SEE THE DATA THAT HE'S REFERRING TO.

MR. BOSTIC: DID YOU EVER HAVE A CHANCE TO LOOK AT ANY PORTION OF THE DATA THAT RESULTED FROM THIS KIND OF TESTING AT THERANOS?

ADAM ROSENDORFF: YES. I BELIEVE THAT I DID SEE DATA OVER THE COURSE OF A WEEK LOOKING AT POTASSIUM VALUES THAT DANIEL HAD GENERATED. I DON'T RECALL WHAT THE DATA INDICATED.

MR. BOSTIC: OKAY. WERE YOU ABLE TO REACH ANY CONCLUSIONS ABOUT THE COMPLETENESS OF THAT DATA OR THE APPROPRIATENESS OF THE TESTING THAT THERANOS WAS RUNNING AT THAT TIME?

ADAM ROSENDORFF: INCOMPLETE.

MR. BOSTIC: AND WHAT MADE YOU CONCLUDE THAT THAT DATA WAS INCOMPLETE?

ADAM ROSENDORFF: WELL, FOR INSTANCE, FOR THE CBC ASSAY, I KEPT -- I KEPT ASKING FOR THE AAP DATA, AND THEN EVENTUALLY SOMEBODY FROM R&D SAID IT'S IN THIS FOLDER, IT'S ALL IN THIS FOLDER. I WENT INTO THE FOLDER, IT WAS AN EXCEL SPREADSHEET THAT WASN'T ANNOTATED, AND I NOTICED THAT THE SPREADSHEET ACTUALLY HAD BEEN CHANGED A FEW MINUTES BEFORE MY INQUIRY. AND I BELIEVE THERE'S AN EMAIL TO THAT EFFECT WITH MR. BALWANI CHASTISING ME FOR MY FRUSTRATION ABOUT THAT.

MR. BOSTIC: AND DURING YOUR CROSS-EXAMINATION, YOU REVIEWED PORTIONS OF THE CLIA REGULATIONS WITH MR. WADE. DO YOU RECALL THAT?

MR. BOSTIC: WHOSE RESPONSIBILITY UNDER THE REGULATIONS IS IT TO IMPLEMENT PROFICIENCY TESTING AT A CLINICAL LABORATORY?

ADAM ROSENDORFF: THE LAB DIRECTOR.

MR. BOSTIC: WHEN YOU WERE ASKED THAT QUESTION ON CROSS-EXAMINATION, YOU STARTED TO EXPLAIN THE PRACTICAL CONCERNS AROUND ACTUALLY IMPLEMENTING --

MR. BOSTIC: -- PROFICIENCY TESTING.

MR. BOSTIC: CAN YOU EXPLAIN WHAT IT TAKES TO ACTUALLY IMPLEMENT PROFICIENCY TESTING AT A LAB LIKE THERANOS?

ADAM ROSENDORFF: SO THERE WERE -- I DON'T KNOW HOW MANY ASSAYS WERE BEING RUN, BUT IT WAS MANY, MANY ASSAYS ON DIFFERENT PLATFORMS. AND IT WOULD HAVE REQUIRED MAJOR COORDINATED EFFORTS WITHIN R&D AND CLIA. IT WOULD HAVE REQUIRED PEOPLE TO BE ASSIGNED DUTIES AND TIMELINES TO COMPLETE THIS, A PLAN FORMED TO RECORD THE RESULTS OF THE PROFICIENCY TESTING. IT ALSO WOULD HAVE TIED UP A LOT OF EDISONS AND THE OTHER LDT'S FOR THE PURPOSES OF PROFICIENCY TESTING AT VARIOUS TIMES. IT ALSO WOULD HAVE INVOLVED REALLY DISCUSSING HOW TO DO THE PROFICIENCY TESTING SPECIFICALLY FOR THE LDT'S THAT WERE BEING RUN ON THE ADVIA. DANIEL HAD MADE A FEW SUGGESTIONS, BUT THE SOP THAT I WROTE WAS SPECIFIC FOR THE EDISONS, SO --

MR. BOSTIC: AND WHEN YOU THINK ABOUT ALL OF THE THINGS THAT WOULD BE REQUIRED TO ACTUALLY IMPLEMENT AND FOLLOW THROUGH ON PROFICIENCY TESTING --

MR. BOSTIC: -- AS YOU'RE DESCRIBING, ARE THOSE THINGS THAT YOU COULD HAVE ALL DONE ON YOUR OWN AT THERANOS?

ADAM ROSENDORFF: THAT I COULD HAVE DONE ON MY OWN?

ADAM ROSENDORFF: NO, ABSOLUTELY NOT.

MR. BOSTIC: WERE THERE THINGS THAT WOULD HAVE BEEN REQUIRED THAT WOULD HAVE NEEDED THE SUPPORT OF UPPER MANAGEMENT IN ORDER TO ACTUALLY FOLLOW THROUGH ON PROFICIENCY TESTING?

MR. BOSTIC: WHEN YOU WERE AT THERANOS, DID YOU FEEL THAT YOU HAD THE SUPPORT OF UPPER MANAGEMENT -- AND I SPECIFICALLY MEAN MS. HOLMES AND MR. BALWANI -- WHEN IT CAME TO IMPLEMENTING PROFICIENCY TESTING?

MR. BOSTIC: WHAT MADE YOU FEEL THAT WAY?

ADAM ROSENDORFF: AFTER THE MEETING IN 2014 WHERE PROFICIENCY TESTING WAS DISCUSSED, THERE WAS NO FOLLOW THROUGH.

MR. BOSTIC: THERE WAS SOME DISCUSSION DURING DIRECT AND ON CROSS-EXAMINATION OF I BELIEVE A TEST THAT YOU CALLED A SPOT CHECK. DO YOU REMEMBER THAT?

MR. BOSTIC: AND, FIRST OF ALL, LET'S LOOK AT EXHIBIT 1548, WHICH IS IN EVIDENCE. AND, DR. ROSENDORFF, DO YOU SEE AN EMAIL FROM FEBRUARY 2014?

MR. BOSTIC: LET'S LOOK AT THE ATTACHMENT TO THIS EMAIL IN NATIVE. OKAY. DR. ROSENDORFF, DO YOU SEE IN FRONT OF YOU DATA FROM THAT SPOT CHECK THAT WE PREVIOUSLY DISCUSSED?

MR. BOSTIC: DURING CROSS-EXAMINATION, THERE WAS SOME DISCUSSION OF HOW AAP OR ALTERNATIVE ASSESSMENT AND PROFICIENCY WAS DIFFERENT FROM STANDARD PT. DO YOU REMEMBER THAT?

MR. BOSTIC: YOUR PREFERENCE BETWEEN THOSE TWO OPTIONS -- WELL, LET ME JUST ASK. WHAT WAS YOUR PREFERENCE BETWEEN THOSE TWO OPTIONS AT THERANOS? SHOULD THERANOS HAVE BEEN USING STANDARD PROFICIENCY TESTING OR AAP FOR ITS COMPANY SPECIFIC TESTS?

MR. BOSTIC: THE DATA THAT WE'RE LOOKING AT IN THIS CHART DOES NOT RESULT FROM AAP; IS THAT CORRECT?

MR. BOSTIC: YOU CALLED IT A SPOT CHECK BEFORE. CAN YOU EXPLAIN WHAT MADE YOU USE THAT TERM? WHY IS THIS A SPOT CHECK IN YOUR VIEW?

ADAM ROSENDORFF: IT'S A -- IT'S A SNAPSHOT IN TIME USING COMMERCIALLY AVAILABLE PT SPECIMENS TO BE RUN ON THE EDISONS. THOSE PT SPECIMENS DID WORK ON THE IMMULITE AND THE EDISONS WERE VALIDATED AGAINST THE IMMULITE. SO I -- IN DISCUSSING THIS WITH THE GROUP, I THOUGHT IT WAS A REASONABLE SPOT CHECK AND AUTHORIZED IT EVEN THOUGH IT WASN'T PART OF A FORMAL SOP.

MR. BOSTIC: SO DESPITE YOUR PREFERENCE FOR AAP AND YOUR ADVOCACY FOR AAP IN THE COMPANY, DID YOU FEEL THAT THIS TEST WAS USEFUL IN ASSESSING THE ACCURACY OF THERANOS TESTS?

MR. BOSTIC: WHO WERE THE OTHER PEOPLE IN THE LAB WHO WERE INVOLVED IN CONDUCTING THIS TESTING AND LOOKING AT THE DATA, IF YOU RECALL?

ADAM ROSENDORFF: I KNOW LANGLY GEE WAS COORDINATING IT. MARK PANDORI AND MYSELF DISCUSSED THE PLAN. ERIKA CHEUNG, I BELIEVE, RAN MANY OF THESE SAMPLES.

MR. BOSTIC: AND DID THOSE INDIVIDUALS SUPPORT THIS APPROACH OF DOING THIS TESTING TO ASSESS THE ACCURACY OF THERANOS'S ASSAYS?

MR. BOSTIC: MARK PANDORI ALSO HAD A SUPERVISORY POSITION IN THE LAB; IS THAT CORRECT?

ADAM ROSENDORFF: I DON'T RECALL.

MR. BOSTIC: DO YOU RECALL GENERALLY WHAT MARK PANDORI'S ROLE AT THERANOS WAS?

ADAM ROSENDORFF: I BELIEVE HE WAS HIRED AS A CO-LABORATORY DIRECTOR. HE HAD A LOT OF EXPERIENCE IN MICROBIOLOGY, SO THE COMPANY WAS -- I GUESS IT'S -- WELL, WHAT MARK TOLD ME WAS THAT HE WAS GOING TO HEAD UP THE MICRO EFFORT AT THERANOS.

MR. BOSTIC: AND DID -- IS IT DR. PANDORI?

MR. BOSTIC: DID DR. PANDORI KNOW WHAT AAP WAS?

MR. BOSTIC: DID DR. PANDORI SUPPORT THE USE OF OR THE IMPLEMENTATION OF AAP AT THERANOS?

ADAM ROSENDORFF: WELL, AT THE TIME THE SPOT CHECK WAS DONE, DR. PANDORI WAS NOT AWARE OF THE DISCUSSIONS -- PERHAPS WAS NOT AWARE OF THE DISCUSSIONS THAT HAD HAPPENED BETWEEN ME AND DANIEL PREVIOUSLY ON THE TOPIC OF AAP.

MR. BOSTIC: OKAY. I UNDERSTAND THAT. DURING YOUR TIME AT THERANOS, DID YOU COME TO UNDERSTAND WHETHER DR. PANDORI HAD A PREFERENCE ON THE USE OF AAP AT THERANOS? DID HE SUPPORT IT OR WAS HE AGAINST IT?

ADAM ROSENDORFF: IN MY DISCUSSIONS WITH HIM, HE -- HE DIDN'T SEEM TO RULE ONE WAY OR THE OTHER.

MR. BOSTIC: DO YOU RECALL REVIEWING A PRESENTATION ON AAP AND THE BENEFITS OF AAP --

MR. BOSTIC: -- PREPARED PARTLY BY DR. PANDORI?

MR. BOSTIC: DID DR. PANDORI SUPPORT THE GENERATION OF THE TEST DATA THAT WE'RE LOOKING AT HERE?

ADAM ROSENDORFF: YES, HE DID.

MR. BOSTIC: HOW WOULD YOU RESPOND TO THE CLAIM THAT BECAUSE THIS TEST DATA WAS NOT GENERATED THROUGH THE FORMAL AAP SOP, THE FORMER PROCEDURE -- THE FORMAL PROCEDURE AT THERANOS, THAT WE SHOULD IGNORE THIS DATA, THAT IT DOESN'T MEAN ANYTHING? WOULD YOU AGREE WITH THAT?

ADAM ROSENDORFF: NO. IT'S VERY FREQUENT IN CLINICAL LABORATORIES TO DO QC CHECKS, PILOT STUDIES, TO DO EVALUATION OF METHODS THAT WOULD NOT BE AN ONGOING PROCESS, SO IT WOULDN'T HAVE TO BE CAPTURED IN SOP BECAUSE YOU'RE NOT PLANNING ON IMPLEMENTING IT ON A REGULAR CADENCE.

ADAM ROSENDORFF: AS LONG AS EVERYBODY IS CLEAR ON WHAT NEEDED TO BE DONE AND HOW THE RESULTS WERE TO BE INTERPRETED.

MR. BOSTIC: WE WERE JUST TALKING ABOUT DR. PANDORI AT THERANOS. WAS HE STILL AT THE COMPANY WHEN YOU DEPARTED IN NOVEMBER 2014?

MR. BOSTIC: DO YOU HAVE AN UNDERSTANDING AS TO WHY HE LEFT THE COMPANY?

ADAM ROSENDORFF: YES, I CAN TELL YOU WHAT HE TOLD ME.

MR. BOSTIC: WHAT DID HE SAY?

MR. WADE: OBJECTION, YOUR HONOR. HEARSAY.

JUDGE DAVILA: SUSTAINED.

MR. BOSTIC: THIS IS UNDER 803(3), YOUR HONOR.

JUDGE DAVILA: I'M GOING TO SUSTAIN THE OBJECTION.

BY MR. BOSTIC:

MR. BOSTIC: DR. ROSENDORFF, LET'S SHIFT GEARS. WE CAN TAKE THAT EXHIBIT DOWN. DO YOU RECALL A DISCUSSION DURING CROSS-EXAMINATION ABOUT PATENTS HELD BY THERANOS?

MR. BOSTIC: YOU SAID THAT THERANOS'S PATENTS, WHEN YOU WERE DECIDING TO JOIN THE COMPANY, INCREASED YOUR EXCITEMENT ABOUT BEING PART OF IT; IS THAT CORRECT?

MR. BOSTIC: ONCE YOU DID JOIN, COULD YOU HAVE SKIPPED THE VALIDATION PROCESS, IGNORED QUALITY CONTROL, AND JUST RELIED ON THOSE PATENTS AS EVIDENCE THAT THE TESTS WERE ACCURATE?

MR. BOSTIC: DOES THE FACT THAT A BLOOD TESTING METHOD IS PATENTED MEAN THAT IT'S ACCURATE?

MR. BOSTIC: DOES ONE HAVE ANYTHING TO DO WITH THE OTHER?

MR. BOSTIC: DO YOU RECALL DISCUSSION DURING YOUR DIRECT EXAMINATION OF A PRACTICE AT THERANOS OF GENERATING MULTIPLE RESULTS FOR A GIVEN ASSAY AND THEN REMOVING TWO OF THEM AND AVERAGING THE REST?

MR. BOSTIC: DURING CROSS-EXAMINATION, YOU WERE ASKED SOME MORE QUESTIONS ABOUT THAT. DO YOU RECALL?

MR. BOSTIC: I WANT TO BE CLEAR ABOUT WHETHER THAT PRACTICE WAS USED BY THE THIRD PARTY DEVICES THAT YOU'VE WORKED WITH. CAN WE BRING UP EXHIBIT 392, PLEASE. THAT'S IN EVIDENCE. AND, DR. ROSENDORFF, DO YOU SEE THAT EXHIBIT 392 IS THE OPERATOR'S GUIDE FOR THE IMMULITE 2000?

MR. BOSTIC: WAS THIS A THIRD PARTY DEVICE THAT YOU HAD EXPERIENCE WITH AT THERANOS?

MR. BOSTIC: LET'S GO TO PAGE 40 OF THIS EXHIBIT, PLEASE. I'M SORRY, PAGE 40. AND IF WE COULD ZOOM IN ON THE BOTTOM HALF OF THAT PAGE. DR. ROSENDORFF, DO YOU SEE A SECTION HERE TITLED TECHNOLOGY, DATA REDUCTION AND THE CHEMILUMINESCENT REACTION INTERNAL CALCULATIONS?

MR. BOSTIC: JUST AT A VERY GENERAL LEVEL, WHAT DOES CHEMILUMINESCENT MEAN IN THIS CONTEXT?

ADAM ROSENDORFF: IT'S THE SIGNAL THAT IS GENERATED WHEN THE ANALYTE IS DETECTED BY THE ANTIBODY IN THE INSTRUMENT. SO IT'S -- THAT SIGNAL IS THEN TRANSLATED INTO AN ACTUAL CONCENTRATION.

MR. BOSTIC: IN OTHER WORDS, IS THE DEVICE MEASURING AN AMOUNT OF LIGHT OUTPUT AND THEN CONVERTING THAT INTO A CONCENTRATION?

MR. BOSTIC: THE LIST HERE TALKS ABOUT INTERNAL CALCULATIONS PERFORMED BY THE SYSTEM WHEN DETERMINING TEST RESULTS. DO YOU SEE THAT NEAR THE TOP OF THAT SECTION?

MR. BOSTIC: TAKE A MOMENT TO JUST FAMILIARIZE YOURSELF WITH THE STEPS 1, 2, 3 LISTED HERE.

(PAUSE IN PROCEEDINGS.)

BY MR. BOSTIC:

MR. BOSTIC: AND I'LL HAVE A QUESTION FOR YOU ABOUT SOMETHING ON THE FOLLOWING PAGE.

MR. BOSTIC: OKAY. IF WE COULD TURN TO THE NEXT PAGE, PAGE 41. AND ZOOM IN ON THE TOP PORTION ONCE WE GET THERE. DR. ROSENDORFF, DO YOU SEE THE CONTINUATION OF THAT LIST WE WERE JUST LOOKING AT?

MR. BOSTIC: ITEM 4 IN THIS LIST OF STEPS --

MR. BOSTIC: -- TALKS ABOUT TAKING FIVE ONE-SECOND READINGS. DO YOU SEE THAT?

MR. BOSTIC: IS THIS THE SAME THING THAT THE THERANOS ANALYZER WAS DOING? IN OTHER WORDS, GENERATING MULTIPLE RESULTS FOR EACH ASSAY AND THEN MANAGING THOSE MULTIPLE RESULTS?

ADAM ROSENDORFF: NO. IF YOU LOOK AT NUMBER 5, WHAT THEY'RE SAYING IS THEY TAKE DARK COUNT READINGS, WHICH I BELIEVE IS BACKGROUND, AND THEY'RE SUBTRACTING IT FROM THE ACTUAL -- THERE'S FIVE READINGS THAT ARE TAKEN. THEY SUBTRACT THE BACKGROUND AND THEN THEY AVERAGE THE FIVE. BUT THEY'RE NOT DISCARDING ANY OF THOSE FIVE.

MR. BOSTIC: SO NONE OF THE ACTUAL RESULTS ARE BEING DISCARDED IN THE THIRD PARTY DEVICE; IS THAT CORRECT?

ADAM ROSENDORFF: CORRECT, CORRECT.

MR. BOSTIC: WHEN IT TALKS ABOUT TAKING FIVE ONE-SECOND READINGS, DOES THAT MEAN THAT THE CHEMICAL REACTION IS ACTUALLY OCCURRING FIVE SEPARATE TIMES?

ADAM ROSENDORFF: NO. IT'S OCCURRING ONCE. IT'S A -- IT'S DIFFERENT SNAPSHOTS OF THE LIGHT THAT'S BEING PUT OUT DURING THOSE FIVE SECONDS.

MR. BOSTIC: IN OTHER WORDS, LIKE TAKING FIVE PICTURES --

MR. BOSTIC: -- OF THE SAME OBJECT?

ADAM ROSENDORFF: YEAH, YEAH.

MR. BOSTIC: IS THAT DIFFERENT FROM HOW THE THERANOS DEVICE WORKED?

ADAM ROSENDORFF: RIGHT. SO THE THERANOS DEVICE HAD SIX SEPARATE TIPS, AT LEAST IN THE 3.5 CONFIGURATION, AND EACH TIP WOULD BE PUTTING OUT ITS OWN CHEMILUMINESCENCE, OR LIGHT.

MR. BOSTIC: SO THIS IS NOT THE SAME AS THAT?

ADAM ROSENDORFF: NO, THEY'RE NOT. THESE ARE FIVE READINGS FROM THE SAME PIECE OF INSTRUMENTATION. IT'S NOT SIX SEPARATE TIPS.

MR. BOSTIC: BY THE WAY, AT THERANOS, DO YOU RECALL DISCUSSION OF HOW EDISON DEVICES WERE USED IN GROUPS OF THREE TO RUN A SINGLE ASSAY?

MR. BOSTIC: AT THERANOS, WAS THAT APPROACH EVER TAKEN WITH THIRD PARTY DEVICES? DID IT REQUIRE MULTIPLE THIRD PARTY DEVICES TO RETURN A SINGLE RESULT?

MR. BOSTIC: WE CAN TAKE THAT EXHIBIT DOWN. THANK YOU. CHANGING TOPICS. DO YOU RECALL TESTIMONY THAT YOU GAVE ABOUT AN INSPECTION OF THERANOS IN 2013 AND WHERE THE INSPECTOR WAS GOING TO INSPECT?

MR. BOSTIC: LET'S LOOK BRIEFLY AT EXHIBIT 4047, WHICH IS IN EVIDENCE. IF WE COULD ZOOM IN ON THE TOP HALF. LET'S CAPTURE THE TEXT BELOW ALSO. ACTUALLY, IF WE COULD CAPTURE MS. HOLMES'S EMAIL AT THE BOTTOM, PLEASE. PERFECT. THANK YOU. DR. YOUNG, DO YOU SEE THIS EMAIL THAT YOU PREVIOUSLY REVIEWED WHERE MS. HOLMES IS ASKING, IN ADVANCE OF AN INSPECTION, ABOUT WHAT THE PATH WILL BE FOR WALKING THE AUDITORS IN AND DOWNSTAIRS?

MR. BOSTIC: IN FRONT OF YOU, YOU SHOULD HAVE -- ACTUALLY, YOU DON'T HAVE IT BECAUSE I HAVEN'T GIVEN IT TO YOU YET. MAY I APPROACH, YOUR HONOR?

MR. BOSTIC: (HANDING.)

MR. BOSTIC: I'VE JUST HANDED YOU WHAT'S MARKED AS EXHIBIT 4316. DO YOU SEE THAT IN FRONT OF YOU?

MR. BOSTIC: AND IS THAT AN EMAIL WHERE THE BOTTOM CHAIN IS FROM DECEMBER 3RD, 2013?

MR. BOSTIC: AND IS IT ANOTHER EMAIL ON THE TOPIC OF THESE INSPECTORS AND WHERE THE INSPECTORS WILL BE ACTUALLY PHYSICALLY LOCATED IN THE HEADQUARTERS?

MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 4316.

MR. WADE: NO OBJECTION, YOUR HONOR.

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

(GOVERNMENT'S EXHIBIT 4316 WAS ADMITTED IN EVIDENCE.)

MR. BOSTIC: AND IF WE COULD ZOOM IN ON THE BOTTOM HALF OF PAGE 1.

MR. BOSTIC: DR. ROSENDORFF, DO YOU SEE THAT EMAIL FROM DANIEL YOUNG TO YOU ON DECEMBER 3RD, 2013?

MR. BOSTIC: THIS IS A FEW DAYS AFTER THE EMAIL FROM MS. HOLMES THAT WE JUST LOOKED AT; CORRECT?

MR. BOSTIC: THE TEXT OF THAT EMAIL SAYS, "LET'S NOT REMIND HER ABOUT THE DOWNSTAIRS LAB UNLESS SHE ASKS AGAIN. JUST SIMPLER IF WE CAN JUST SHOW HER THE LAB UPSTAIRS." DO YOU SEE THAT?

MR. BOSTIC: WAS THIS DAY THE DAY OF THE INSPECTION?

MR. BOSTIC: THE "HER" THAT DANIEL YOUNG IS REFERRING TO, IS THAT THE INSPECTOR?

MR. BOSTIC: AND CAN YOU REMIND US WHAT THE DIFFERENCE WAS BETWEEN THE DOWNSTAIRS LAB AND THE UPSTAIRS LAB?

ADAM ROSENDORFF: THE DOWNSTAIRS LAB HAD THE LDT'S, THE MODIFIED METHODS, MODIFIED -- THE THERANOS METHODS, ESSENTIALLY. THE UPSTAIRS LAB HAD THE FDA APPROVED INSTRUMENTS.

MR. BOSTIC: MS. HOLMES'S EMAIL THAT WE JUST LOOKED AT, EXHIBIT 4047, DO YOU RECALL WHETHER THAT INCLUDED DANIEL YOUNG ON THE EMAIL?

ADAM ROSENDORFF: I'M SORRY, I DON'T RECALL THE RECIPIENT LIST.

MR. BOSTIC: THAT'S OKAY. LET'S GO BACK TO IT BRIEFLY. AND LET'S -- THANK YOU. DO YOU SEE THAT MS. HOLMES'S EMAILS, BOTH OF THEM ON THIS CHAIN INCLUDED DANIEL YOUNG?

MR. BOSTIC: NOW LET'S GO BACK TO EXHIBIT 4316 AND ZOOM BACK IN ON THE BOTTOM PART. DR. ROSENDORFF, ON NOVEMBER 7TH, 2014, IT APPEARS THAT YOU FORWARDED THIS MESSAGE. DO YOU SEE THAT?

MR. BOSTIC: AND WE'VE REDACTED THE EMAIL ADDRESS THAT YOU FORWARDED IT TO, BUT DO YOU RECALL FORWARDING THIS EMAIL TO YOUR GMAIL ACCOUNT ON THAT DATE?

MR. BOSTIC: WHY DID YOU DO THAT ALMOST A YEAR LATER IN NOVEMBER 2014?

ADAM ROSENDORFF: I -- AGAIN, I WAS CONCERNED ABOUT POSSIBLE GOVERNMENT OR CMS INVESTIGATIONS IN THE LABORATORY AND I WANTED TO HAVE DOCUMENTATION OF THE DISCUSSIONS AROUND THE, THE DAY OF THE INSPECTION.

MR. BOSTIC: AND WHAT WAS IT ABOUT THIS PARTICULAR EMAIL THAT YOU THOUGHT NEEDED TO BE DOCUMENTED?

ADAM ROSENDORFF: IT TROUBLED ME THAT WE WEREN'T TALKING ABOUT THE DOWNSTAIRS LAB. IT APPEARS FROM DR. YOUNG'S EMAIL THAT SHE HAD ASKED ABOUT IT. I'M NOT REALLY -- I DON'T HAVE A VERY CLEAR RECOLLECTION OF WHAT THE DISCUSSION WAS WITH THE REGULATOR. THERE WAS SOMETHING ABOUT IT THAT BOTHERED ME, THOUGH.

MR. BOSTIC: DID YOU FEEL THAT THERANOS SHOULD HAVE BEEN MORE TRANSPARENT WITH THE REGULATOR ON THAT OCCASION?

ADAM ROSENDORFF: WELL, WE -- WE SHOWED THE REGULATOR EVERYTHING SHE WANTED TO SEE IN THE LAB, SO I THINK WE RESPONDED TO THE AUDIT APPROPRIATELY.

MR. BOSTIC: DO YOU RECALL RECEIVING ANY ADDITIONAL INSTRUCTION FROM MANAGEMENT ABOUT HOW TO HANDLE IT IF THE INSPECTOR DID ASK ABOUT THE DOWNSTAIRS LAB OR ENTERED THE DOWNSTAIRS LAB?

MR. BOSTIC: I'D LIKE TO SHOW YOU WHAT WE'VE MARKED AS EXHIBIT 1295. MAY I APPROACH, YOUR HONOR?

MR. BOSTIC: (HANDING.)

MR. BOSTIC: DR. ROSENDORFF, DO YOU HAVE EXHIBIT 1295 IN FRONT OF YOU?

MR. BOSTIC: AND IS IT AN EMAIL DATED, AGAIN, DECEMBER 3RD, 2013, THE SAME DATE AS THE INSPECTION?

MR. BOSTIC: AND IS IT FROM SUNNY BALWANI TO YOU, DANIEL YOUNG, AND OTHER EMPLOYEES AT THERANOS?

MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 1295.

MR. WADE: NO OBJECTION.

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

(GOVERNMENT'S EXHIBIT 1295 WAS ADMITTED IN EVIDENCE.)

BY MR. BOSTIC:

MR. BOSTIC: IF WE COULD ZOOM IN. OKAY. DR. ROSENDORFF, DO YOU SEE THAT THIS IS AN E-MAIL FROM SUNNY BALWANI TO YOU AND OTHER MEMBERS OF THE STAFF ON THE DATE OF THE INSPECTION?

MR. BOSTIC: THE TEXT OF THE EMAIL READS, "FOR THE AREA INSIDE THE NORMANDY LAB THAT IS CORDONED OFF BY THE DIVIDERS, IF THE INSPECTOR ASKS, WE SHOULD SAY THIS AREA IS FOR FUTURE GROWTH AND IS BEING ORGANIZED (AS IS THE CASE) BUT IS STILL RESTRICTED ONLY TO THE CLIA LAB AND AUTHORIZED TEAM (AS IS THE CASE)." DO YOU SEE THAT?

MR. BOSTIC: DO YOU RECALL A PORTION OF THE NORMANDY LAB BEING BEHIND DIVIDERS FOR THIS INSPECTION?

MR. BOSTIC: DO YOU RECALL WHAT WAS ON THE OTHER SIDE OF THAT DIVIDED PORTION?

ADAM ROSENDORFF: THE EDISONS.

MR. BOSTIC: IN YOUR EXPERIENCE AS A LABORATORY DIRECTOR, IS IT NORMAL FOR MANAGEMENT TO GIVE THIS KIND OF SCRIPTING TO A LABORATORY DIRECTOR DIRECTING THEM ON HOW TO RESPOND TO INSPECTOR QUESTIONS?

MR. BOSTIC: OKAY. WE CAN PUT THAT ASIDE. DO YOU RECALL SOME DISCUSSION DURING CROSS-EXAMINATION OF SITUATIONS WHERE A LAB DIRECTOR MIGHT COVER MULTIPLE LABS AT THE SAME TIME?

MR. BOSTIC: AND YOU TESTIFIED THAT YOU HAD SUPERVISED UP TO THREE LABS AT ONCE IN YOUR CAREER?

MR. BOSTIC: DURING YOUR TIME AT THERANOS, WERE YOU SERVING AS A LAB DIRECTOR ANYWHERE ELSE?

MR. BOSTIC: AND WHY WAS THAT?

ADAM ROSENDORFF: I WANTED TO GIVE MY FULL ENERGY AND ATTENTION TO THERANOS. IT WAS A COMPLICATED LABORATORY WITH CONSTANT ISSUES COMING UP. I DIDN'T FEEL I HAD THE BANDWIDTH TO BE RESPONSIBLE FOR ANOTHER LABORATORY AT THAT TIME.

MR. BOSTIC: ARE SOME CLINICAL LABORATORIES MORE COMPLICATED TO SUPERVISE THAN OTHERS?

MR. BOSTIC: AND HOW DOES -- OR HOW DID THERANOS STACK UP IN YOUR EXPERIENCE?

ADAM ROSENDORFF: IT'S THE MOST COMPLICATED LABORATORY I'VE EVER HAD TO SUPERVISE OR DIRECT.

MR. BOSTIC: AND DID PART OF THAT RELATE TO THE PROBLEMS THAT YOU SAW WHEN YOU WERE LABORATORY DIRECTOR?

MR. BOSTIC: DO YOU RECALL A DISCUSSION DURING CROSS-EXAMINATION REGARDING A TIME WHEN YOU CONSIDERED BRINGING SOMETHING CALLED A QUI TAM LAWSUIT AGAINST THERANOS?

MR. BOSTIC: BASED ON YOUR UNDERSTANDING, DOES THAT KIND OF LAWSUIT INVOLVE THE FEDERAL GOVERNMENT AT ALL?

MR. BOSTIC: HOW SO? WHAT'S YOUR UNDERSTANDING?

ADAM ROSENDORFF: I BELIEVE THE LAWSUIT IS BROUGHT TO THE FEDERAL GOVERNMENT EITHER THROUGH CMS OR THROUGH SOME OTHER AGENCY WITHIN THE FEDERAL GOVERNMENT, HEALTH AND HUMAN SERVICES? I'M NOT REALLY SURE. I KNOW THAT IT INVOLVES MEDICARE, WHICH IS A GOVERNMENT RUN PROGRAM. THERE IS A RELATER OR SOMEBODY WHO COMMUNICATES THE FRAUD TO THE GOVERNMENT. I KIND OF LOST TRACK OF YOUR QUESTION. I DON'T KNOW, I'M JUST -- I'M DESCRIBING MY UNDERSTANDING OF A QUI TAM.

MR. BOSTIC: THAT'S FINE. I THINK YOU'VE ANSWERED IT.

MR. BOSTIC: ON CROSS, MR. WADE SUGGESTED THAT YOU WERE SEEKING A FINANCIAL REWARD IN EXPLORING THAT OPTION. DO YOU RECALL THAT?

MR. BOSTIC: WAS THAT YOUR GOAL IN CONSIDERING TAKING THAT STEP?

MR. BOSTIC: WHAT WAS YOUR GOAL?

ADAM ROSENDORFF: TO CORRECT -- TO RIGHT THE WRONGS, BASICALLY, TO ALERT THE PUBLIC OF WHAT WAS GOING ON AT THERANOS. I FELT A RESPONSIBILITY FOR THIS TO SEE THE LIGHT OF DAY. I WAS UNSURE WHAT AVENUE TO PURSUE. I WAS EXPLORING DIFFERENT AVENUES.

MR. BOSTIC: OKAY. WHEN YOU WERE QUESTIONED ABOUT THE POSSIBILITY OF A FINANCIAL REWARD, YOU MENTIONED THE EXTENT TO WHICH THERANOS WAS INVOLVED IN MEDICARE. DO YOU REMEMBER THAT?

MR. BOSTIC: EXPLAIN WHAT THE CONNECTION WAS THERE IN YOUR MIND.

ADAM ROSENDORFF: MY UNDERSTANDING WHILE I WORKED AT THERANOS IS THAT MOST OF THE PATIENTS WERE ACTUALLY PAYING OUT OF POCKET FOR THESE TESTS BECAUSE THERANOS WAS TOUTING THE TESTS AS BEING MUCH CHEAPER THAN OTHER LABS. AND I -- I BELIEVE THERE WERE SOME PRIVATE INSURERS THAT WERE INVOLVED IN PAYING FOR THE TESTS. THERE WAS AN EFFORT TO RECOVER MONIES FROM PRIVATE INSURERS BECAUSE THERE WAS SOME PAPERWORK ISSUE WITH BILLING. I REMEMBER THAT. SO I KNOW THAT PRIVATE INSURERS WERE INVOLVED. BUT I NEVER SAW ANY INFORMATION REGARDING MEDICARE BILLING, SO I DIDN'T THINK THAT THERE ACTUALLY WOULD BE ANY MONEY RECOVERABLE ON THE BASIS OF MEDICARE FRAUD.

MR. BOSTIC: IT WAS YOUR UNDERSTANDING THAT ANY FINANCIAL RECOVERY YOU MIGHT GET FROM THE LAWSUIT WOULD BE BASED ON THE AMOUNT OF THERANOS'S WORK WITH MEDICARE?

ADAM ROSENDORFF: YES. IS THAT ACCURATE? SORRY.

MR. BOSTIC: I DON'T WANT YOU TO REVEAL THE CONTENT OF ANY PRIVILEGED CONVERSATION THAT YOU HAD WITH YOUR ATTORNEY --

MR. BOSTIC: -- BUT CAN YOU TELL US WHEN YOU FIRST STARTED EXPLORING THE POSSIBILITY OF A QUI TAM LAWSUIT AGAINST THERANOS?

ADAM ROSENDORFF: I BELIEVE MY FIRST MEETING WITH THE ATTORNEY WAS MID-2014.

MR. BOSTIC: ULTIMATELY, YOU DID NOT GET INVOLVED IN THAT KIND OF LAWSUIT; CORRECT?

MR. BOSTIC: AND JUST TO BE CLEAR, YOU'RE TESTIFYING HERE IN A CRIMINAL PROSECUTION; CORRECT?

MR. BOSTIC: DO YOU HAVE ANY HOPE OR EXPECTATION OF RECEIVING ANY BENEFIT IN CONNECTION WITH YOUR TESTIMONY IN THIS PROSECUTION?

ADAM ROSENDORFF: NO. ON THE CONTRARY.

MR. BOSTIC: DO YOU RECALL A DISCUSSION ABOUT YOUR FINANCIAL COMPENSATION AT THERANOS?

MR. BOSTIC: YOU TESTIFIED THAT WHEN YOU LEFT THE COMPANY, MR. BALWANI INVITED YOU TO SAY ON.

MR. BOSTIC: DID YOU ASK MR. BALWANI FOR A RAISE AT THAT TIME?

MR. BOSTIC: WHEN YOU LEFT THE COMPANY, WAS YOUR DECISION TO LEAVE THE COMPANY ABOUT MONEY?

MR. BOSTIC: WHAT WAS IT ABOUT?

ADAM ROSENDORFF: IT WAS ABOUT PATIENT CARE AND MY INTEGRITY AS A PHYSICIAN.

MR. BOSTIC: I WANT TO CIRCLE BACK TO THE PRACTICE THAT YOU HAD OF FORWARDING CERTAIN EMAILS TO YOUR PERSONAL EMAIL ACCOUNT. DO YOU RECALL TESTIFYING ABOUT THAT?

MR. BOSTIC: DURING YOUR CROSS-EXAMINATION, MR. WADE ACCUSED YOU OF STEALING COMPANY TRADE SECRET INFORMATION. DO YOU RECALL THAT?

MR. BOSTIC: DID YOU EVER DISCLOSE ANY OF THE INFORMATION IN THE EMAILS YOU FORWARDED TO ANY OTHER LABS OR COMPETITORS OF THERANOS?

MR. BOSTIC: DID YOU EVER CONSIDER DOING THAT?

MR. BOSTIC: BASED ON YOUR EXPERIENCE WITH THE THERANOS TESTING METHODS, WOULD YOU HAVE WANTED OTHER METHODS -- EXCUSE ME. WOULD YOU HAVE WANTED OTHER LABORATORIES TO USE THOSE METHODS?

MR. BOSTIC: MR. WADE ALSO CRITICIZED YOU FOR FORWARDING AN EMAIL TO YOURSELF THAT CONTAINED PATIENT IDENTIFYING INFORMATION. DO YOU RECALL THAT?

MR. BOSTIC: DID THE WELFARE OF THOSE PATIENTS PLAY ANY ROLE IN YOUR DECISION TO FORWARD THAT EMAIL TO YOURSELF?

ADAM ROSENDORFF: AS LABORATORY DIRECTOR, THOSE WERE PATIENTS UNDER MY CARE AND I -- I WANTED TO BE ABLE TO RESPOND TO QUERIES THAT CAME TO ME AFTER I LEFT THERANOS FROM ANY OF THOSE PATIENTS. I DID NOT SHARE ANY OF THAT INFORMATION WITH THIRD PARTIES. AND AS I TESTIFIED, I DELETED ALL OF THOSE EMAILS I BELIEVE THE EVENING THAT I LEFT THERANOS.

MR. BOSTIC: ON CROSS-EXAMINATION, MR. WADE ASKED YOU WHETHER CUSTOMER SERVICE WAS IMPORTANT AT THERANOS. DO YOU REMEMBER THAT QUESTION?

MR. BOSTIC: YOUR ANSWER AT THE TIME WAS THAT YOU COULDN'T ANSWER YES OR NO. DO YOU REMEMBER THAT?

MR. BOSTIC: WHAT'S THE COMPLETE ANSWER TO THAT QUESTION? WHY COULDN'T YOU ANSWER YES OR NO?

ADAM ROSENDORFF: I -- I THINK BECAUSE IF CUSTOMER SERVICE WAS TRULY IMPORTANT TO THE COMPANY, THERE WOULD HAVE BEEN MUCH GREATER DEGREE OF TRANSPARENCY WITH THE PUBLIC.

MR. BOSTIC: LET'S TALK SOME MORE ABOUT THE CLIA REGULATIONS GOVERNING CLINICAL LAB PRACTICE.

MR. BOSTIC: ON CROSS-EXAMINATION, MR. WADE SHOWED YOU SECTIONS OF THE REGULATIONS THAT GIVE THE LABORATORY DIRECTOR RESPONSIBILITY AND POWER OVER A NUMBER OF ISSUES IN THE LAB; IS THAT CORRECT?

MR. BOSTIC: AND IS THAT CONSISTENT WITH WHAT YOUR UNDERSTANDING WAS OF THE ROLE WHEN YOU WERE LAB DIRECTOR AT THERANOS?

ADAM ROSENDORFF: SO CLIA ALSO MAKES THE OWNER OR THE OPERATOR OF THE LABORATORY RESPONSIBLE IN THE EVENT THAT THERE ARE ANY VIOLATIONS OF ANY OF THE CLIA STATUTES UNDER C.F.R. 493. GO AHEAD. I'M SORRY.

MR. BOSTIC: AND WERE YOU GENERALLY AWARE OF THE PROVISIONS OF THOSE REGULATIONS DURING YOUR TIME AS LAB DIRECTOR AT THERANOS?

MR. BOSTIC: DO YOU AGREE THAT THE POSITION OF LABORATORY DIRECTOR COMES WITH CONSIDERABLE AUTHORITY?

ADAM ROSENDORFF: IT COMES WITH CONSIDERABLE RESPONSIBILITY AND AN ASSUMPTION OF AUTHORITY, YEAH.

MR. BOSTIC: CAN YOU EXPLAIN THE DIFFERENCE BETWEEN RESPONSIBILITY AND AUTHORITY IN THAT CONTEXT?

ADAM ROSENDORFF: SO RESPONSIBILITY IS WHAT YOU'RE LEGALLY RESPONSIBLE FOR IN THE EYES OF CMS IN TERMS OF HOW THE LAB FUNCTIONS AND PERFORMS, THE ACCURACY OF ITS TESTING, HOW THE LAB REPORTS TESTING, HOW IT HANDLES SAMPLES, ET CETERA, ET CETERA. AUTHORITY IS THE ACTUAL POWER TO MAKE THOSE THINGS HAPPEN AND IMPLEMENT THEM IN THE LABORATORY.

MR. BOSTIC: LET'S TALK ABOUT ACTUAL POWER AT THERANOS THEN. IN YOUR EXPERIENCE AT THE COMPANY, WHAT WAS THE POWER DYNAMIC LIKE BETWEEN YOU ON THE ONE HAND AND ELIZABETH HOLMES ON THE OTHER HAND, FOR EXAMPLE?

ADAM ROSENDORFF: CAN YOU BE -- CAN YOU BE MORE SPECIFIC?

MR. BOSTIC: IN YOUR ROLE AS LAB DIRECTOR AT THERANOS, DID YOU HAVE CO-EQUAL POWER WITH MS. HOLMES IN THE COMPANY? DID ONE OF YOU HAVE AUTHORITY OVER THE OTHER? TELL US HOW THAT WORKED.

ADAM ROSENDORFF: WELL, MR. BALWANI WAS HEAVILY INVOLVED IN DIRECTING THE CLIA LABORATORY. HE WOULD MAKE FIRING DECISIONS WITHOUT ME. AND ALSO, AS WE'VE SEEN THROUGH THIS TRIAL, NUMEROUS LABORATORY AND OPERATIONAL DECISIONS THAT DIDN'T INVOLVE ME. AND I ASSUMED HE WAS DISCUSSING THOSE WITH ELIZABETH.

MR. BOSTIC: GENERALLY SPEAKING IN THE COMPANY, WHO HAD MORE POWER, YOU OR THE CEO, MS. HOLMES?

ADAM ROSENDORFF: MS. HOLMES.

MR. BOSTIC: DID MS. HOLMES'S POWER AND HER AUTHORITY IN THE COMPANY COME FROM THE CLIA REGULATIONS?

ADAM ROSENDORFF: NO. IT CAME FROM BUSINESS PRIORITIES.

MR. BOSTIC: AND HER POSITION AT THE COMPANY?

MR. BOSTIC: IF YOU HAD BEEN LAB DIRECTOR AND CEO OF THERANOS, IF YOU HAD HAD THE POWER TO DO WHATEVER YOU WANTED AT THE COMPANY, CAN YOU GIVE US SOME EXAMPLES OF THINGS THAT WOULD HAVE BEEN DIFFERENT, THINGS THAT YOU WOULD HAVE DONE DIFFERENTLY?

MR. WADE: OBJECTION, YOUR HONOR.

JUDGE DAVILA: SUSTAINED. YOU CAN ASK A DIFFERENT METHOD. AS TO THE FORM OF THE QUESTION, OBJECTION SUSTAINED.

BY MR. BOSTIC:

MR. BOSTIC: DR. ROSENDORFF, DURING YOUR TIME AT THERANOS, WERE THERE THINGS THAT YOU THOUGHT SHOULD HAVE BEEN DONE TO ENSURE THE ACCURACY OF THE TESTING THAT YOU DIDN'T HAVE THE POWER TO DO?

ADAM ROSENDORFF: I MIGHT SUGGEST -- FOR INSTANCE, I MADE SUGGESTIONS ABOUT BEING TRANSPARENT WITH CUSTOMERS ABOUT WHETHER FINGERSTICK OR VENOUS BLOOD HAD BEEN DRAWN AND WHAT METHOD HAD BEEN USED. THAT DIDN'T HAPPEN. I HAD HAD A, AN ARGUMENT, PER SE, OR A DISCUSSION WITH DANIEL DURING THE VALIDATION PHASE ABOUT THE FACT THAT ACTUALLY PAIRED VENOUS AND FINGERSTICK SAMPLES WOULD BE A BETTER WAY TO ASSESS ACCURACY THAN JUST DILUTING VENOUS. BUT IN VIEW OF THE RUSH FOR THE LAUNCH, THAT WASN'T SOMETHING THAT THE COMPANY WAS GOING TO AGREE TO.

MR. BOSTIC: IN THE SITUATIONS THAT YOU JUST DESCRIBED, WERE YOU THE ULTIMATE DECIDER ON HOW THE COMPANY HANDLED THOSE SITUATIONS?

MR. BOSTIC: WHO WERE THE ULTIMATE DECIDERS IN THOSE SITUATIONS?

ADAM ROSENDORFF: THE EXECUTIVES.

MR. BOSTIC: WHO ARE WE TALKING ABOUT THERE?

ADAM ROSENDORFF: ELIZABETH, SUNNY, AND DANIEL, WHO WAS THE VICE PRESIDENT.

MR. BOSTIC: DO YOU RECALL TESTIMONY DURING CROSS-EXAMINATION ABOUT YOUR VIEW OF MS. HOLMES'S QUALIFICATIONS AND WHETHER SHE WOULD HAVE BEEN QUALIFIED, FOR EXAMPLE, TO BE A LAB DIRECTOR HERSELF?

MR. BOSTIC: AND YOU WERE ANSWERING BASED ON WHAT THE REGULATIONS REQUIRE; IS THAT RIGHT?

MR. BOSTIC: IN PRACTICE AT THERANOS -- WELL, LET ME ASK A SEPARATE QUESTION FIRST. DOES THE SAME GO FOR MR. BALWANI AND YOUR TESTIMONY ABOUT HIS QUALIFICATIONS?

MR. BOSTIC: IN PRACTICE AT THERANOS, DID MS. HOLMES AND MR. BALWANI NEED TO QUALIFY UNDER THE REGULATIONS TO INFLUENCE OPERATIONS IN THE LABORATORY?

MR. BOSTIC: AND THAT'S -- THAT WAS A REQUIREMENT BASED ON THE REGULATIONS; CORRECT?

MR. BOSTIC: IS THAT HOW IT ACTUALLY WORKED AT THE COMPANY IN PRACTICE?

MR. BOSTIC: HOW DID IT WORK AT THE COMPANY IN PRACTICE?

ADAM ROSENDORFF: SUNNY HAD A STRONG HAND IN, IN THE OPERATIONS OF THE LAB. FOR INSTANCE, HIS DECISION BEHIND MY BACK THAT VACUTAINERS SHOULD BE ALIQUOTED INTO CTN'S THAT I HAD NO AWARENESS OF. DANIEL YOUNG WAS HEAVILY INVOLVED IN CLIA LAB OPERATIONS. AND MS. HOLMES WAS AWARE OF ALL OF THAT.

MR. BOSTIC: I'D LIKE TO SHOW YOU WHAT'S BEEN MARKED AS EXHIBIT 5417. MAY I APPROACH, YOUR HONOR?

MR. BOSTIC: (HANDING.)

MR. BOSTIC: AND, DR. ROSENDORFF, DO YOU HAVE EXHIBIT 5417 IN FRONT OF YOU?

MR. BOSTIC: IS THAT AN EMAIL CHAIN WITH THE SUBJECT LINE PHYSICIAN QUESTIONING RESULTS BETWEEN INDIVIDUALS AT THERANOS, INCLUDING MR. BALWANI AND ELIZABETH HOLMES?

MR. BOSTIC: YOUR HONOR, MOVE TO ADMIT EXHIBIT 5417.

MR. WADE: COURT'S INDULGENCE FOR ONE MOMENT.

(PAUSE IN PROCEEDINGS.)

MR. WADE: NO OBJECTION.

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

(GOVERNMENT'S EXHIBIT 5417 WAS ADMITTED IN EVIDENCE.)

BY MR. BOSTIC:

MR. BOSTIC: AND THIS IS AN EMAIL CHAIN, DR. ROSENDORFF, ABOUT THE PHYSICIAN QUESTIONING RESULTS. DO YOU SEE THAT?

MR. BOSTIC: I'D LIKE TO DRAW YOUR ATTENTION TO THE BOTTOM OF THE FIRST PAGE, PLEASE.

MR. BOSTIC: AND IF WE COULD ZOOM IN JUST ON THE BOTTOM TWO MESSAGES. DR. ROSENDORFF, DO YOU SEE AT THE BOTTOM, THERE'S AN EMAIL FROM SUNNY BALWANI TO SOMEONE NAMED NICHOLAS MENCHEL?

MR. BOSTIC: DO YOU RECALL WHO NICHOLAS MENCHEL WAS AT THE COMPANY?

ADAM ROSENDORFF: SO THERE WERE THREE INDIVIDUALS WHO WENT TO, OR ATTENDED DUKE UNIVERSITY WITH EACH OTHER. IT WAS MAX, NICK, AND ANOTHER PERSON. THEY WERE FACTOTUMS OF A SORT. THEY PERFORMED MANY DIFFERENT FUNCTIONS IN THE LAB.

MR. BOSTIC: OKAY. MR. BALWANI'S E-MAIL TO MR. MENCHEL ON JULY 19TH, 2014 SAYS, "NICK, THIS WAS NOT COMMUNICATED TO ME UNTIL I SAW THIS A FEW MINUTES AGO." HE'S REFERRING TO AN EARLIER CONVERSATION HERE. HE THEN SAYS, "YOU KNOW, I AM RUNNING CLIA LAB NOW SO IF YOU WANT TO STAY INVOLVED FROM CALL CENTER PERSPECTIVE, YOU NEED TO MAKE APPOINT THAT I GET LOOKED IN." DO YOU SEE THAT?

MR. BOSTIC: JULY 2014, WERE YOU STILL PRESENT AT THE COMPANY?

ADAM ROSENDORFF: YES, I WAS.

MR. BOSTIC: WHAT WAS YOUR POSITION AT THE COMPANY IN JULY 2014?

ADAM ROSENDORFF: LABORATORY DIRECTOR.

MR. BOSTIC: WHAT'S YOUR REACTION TO MR. BALWANI'S STATEMENT, "I AM RUNNING CLIA LAB NOW"?

ADAM ROSENDORFF: AFTER MARK PANDORI'S EXIT FROM THE COMPANY, SUNNY BALWANI COMMUNICATED TO ME THAT HE HAD A UNIQUE SET OF SKILLS AND TALENTS THAT WOULD QUALIFY HIM TO DIRECT THE CLIA LAB ESSENTIALLY. I DIDN'T RESPOND TO THAT. AND SO I'M NOT SURPRISED THAT HE'S SAYING HERE, "I'M RUNNING THE CLIA LAB NOW." HE'S CLEARLY NOT QUALIFIED UNDER THE REGULATIONS.

MR. BOSTIC: I'LL DRAW YOUR ATTENTION TO THE VERY TOP OF PAGE 1, AND IF WE CAN ZOOM IN JUST ON THE TOP MESSAGE. DO YOU SEE THAT AT THE TOP OF THIS EMAIL CHAIN, THERE'S ANOTHER MESSAGE FROM MR. BALWANI ON THAT SAME DATE TO NICHOLAS MENCHEL AND BCC'ING ELIZABETH HOLMES --

MR. BOSTIC: -- FORWARDING TO HER THE REST OF THIS EMAIL CHAIN. DO YOU SEE THAT?

MR. BOSTIC: DID THE CLIA REGULATIONS GIVE YOU THE POWER AT THERANOS TO OVERRULE ELIZABETH HOLMES AND SUNNY BALWANI?

MR. BOSTIC: AND I'M ASKING IN PRACTICE BASED ON HOW IT ACTUALLY WORKED AT THE COMPANY.

ADAM ROSENDORFF: SO THERE'S A CLEAR CONFLICT BETWEEN THE ORGANIZATIONAL CHART AT THE COMPANY WHERE BOTH SUNNY AND ELIZABETH ARE ABOVE ME IN THAT ORG CHART, I REPORT TO THEM AND I'M RESPONSIBLE TO THEM. ON THE OTHER HAND, THE CLIA REGULATIONS SAY THAT I'M RESPONSIBLE FOR ESSENTIALLY EVERYTHING THAT HAPPENS IN THE LABORATORY.

MR. BOSTIC: AND IN PRACTICE AT THERANOS, DID ELIZABETH HOLMES AND SUNNY BALWANI DEFER TO YOU ON THOSE ISSUES BASED ON THE CLIA REGULATIONS?

MR. BOSTIC: ALL THE TIME?

MR. BOSTIC: DO YOU RECALL REVIEWING, DURING YOUR TESTIMONY, AN EMAIL INCLUDING MR. BALWANI AND ELIZABETH HOLMES WHERE YOU RAISED ISSUES REGARDING CLIA COMPLIANCE?

MR. BOSTIC: AND IN CONNECTION WITH THE ISSUES YOU RAISED THERE, DID MS. HOLMES AND MR. BALWANI DEFER TO YOUR JUDGMENT?

ADAM ROSENDORFF: SO I BELIEVE THAT WAS AN EMAIL I SENT ON A SUNDAY STATING THAT WE WEREN'T IN COMPLIANCE WITH A NUMBER OF CLIA STATUTES. AND SUNNY RESPONDED THAT HE WAS GOING TO GET THE TEAMS TO WORK ON IT AND SPEND LONG HOURS.

MR. BOSTIC: DO YOU REMEMBER MS. HOLMES DIRECTING THAT EMAIL THAT NO ONE SHOULD BE GUESSING ABOUT THOSE ISSUES?

ADAM ROSENDORFF: MS. HOLMES'S EMAIL ABOUT THE GUESSING WAS ABOUT -- WAS BASICALLY PUTTING A STOP TO THE BACK AND FORTH ABOUT PROFICIENCY TESTING. SO IT WAS FOLLOWING ON THE HEELS OF THAT SPOT CHECK THAT WE DISCUSSED, AND THERE WAS A DISCUSSION BETWEEN DANIEL AND MYSELF AND SUNNY ABOUT WHAT'S APPROPRIATE IN TERMS OF PROFICIENCY TESTING, AND ELIZABETH SAID, YOU KNOW, WE ENGAGED DIRECTLY WITH YOUR COUNSEL A LONG TIME ABOUT THIS AND NOBODY SHOULD BE GUESSING ON THESE MATTERS.

MR. BOSTIC: AND AT THE TIME, DID YOU FEEL THAT THAT'S WHAT YOU WERE DOING? WERE YOU GUESSING ON THOSE REGULATORY MATTERS?

MR. BOSTIC: IN THAT SITUATION, DID MS. HOLMES DEFER TO YOU AS LAB DIRECTOR?

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

(DISCUSSION OFF THE RECORD AMONGST GOVERNMENT COUNSEL.)

BY MR. BOSTIC:

MR. BOSTIC: DR. ROSENDORFF, YOU TESTIFIED A MOMENT AGO THAT UNDER THE REGULATIONS, THE OWNER OR OPERATOR OF A LAB ALSO HAS RESPONSIBILITIES.

MR. BOSTIC: CAN YOU EXPLAIN HOW THAT FITS INTO THE PICTURE BASED ON YOUR UNDERSTANDING?

ADAM ROSENDORFF: IF CMS DECIDES TO SANCTION THE LABORATORY BASED ON NONCOMPLIANCE, IT CAN IMPOSE FINES AND PENALTIES ON EITHER THE LABORATORY DIRECTOR OR THE OWNER/OPERATOR OR BOTH.

MR. BOSTIC: DO YOU RECALL TESTIMONY DURING CROSS-EXAMINATION WHERE MR. WADE ASKED YOU ABOUT WHETHER EVERY LAB MAKES OCCASIONAL MISTAKES?

MR. BOSTIC: AND DO YOU AGREE WITH THAT STATEMENT, THAT EVERY LAB SOMETIMES MAKES MISTAKES?

MR. BOSTIC: YOU'VE WORKED AT MULTIPLE LABS; IS THAT CORRECT?

ADAM ROSENDORFF: YES, MANY, MANY LABS.

MR. BOSTIC: APPROXIMATELY HOW MANY LABS HAVE YOU WORKED AT IN YOUR 13 YEARS OF EXPERIENCE?

ADAM ROSENDORFF: IT'S SIX NOW. YEAH.

MR. BOSTIC: NONE OF THOSE LABS HAS BEEN PERFECT; IS THAT RIGHT?

MR. BOSTIC: WERE THE PROBLEMS THAT YOU SAW AT THERANOS IN LINE WITH WHAT YOU WOULD EXPECT TO SEE AT ANY LABORATORY?

MR. BOSTIC: WERE THEY WORSE THAN THAT?

MR. BOSTIC: AT ANY OTHER LABORATORY, DID YOU EVER RESORT TO FORWARDING EVIDENCE TO YOUR PERSONAL EMAIL ACCOUNT BECAUSE YOU WORRIED ABOUT FUTURE INVESTIGATIONS INTO LAB PRACTICES?

MR. BOSTIC: NO FURTHER QUESTIONS. THANK YOU, YOUR HONOR.

JUDGE DAVILA: LET'S TAKE OUR MORNING BREAK NOW, LADIES AND GENTLEMEN. LET'S TAKE 45 MINUTES, 45 MINUTES. AND THEN WE'LL COME BACK. WILL YOU HAVE CROSS-EXAMINATION, OR RECROSS?

MR. WADE: I WILL, YOUR HONOR.

JUDGE DAVILA: ALL RIGHT. THANK YOU.

COURT CLERK: COURT IS IN RECESS.

JUDGE DAVILA: YOU CAN STAND DOWN, DOCTOR, AS WELL.