Audra Zachman — Direct/Cross/Redirect
756 linesDIRECT EXAMINATION BY MR. BOSTIC:
MR. BOSTIC: GOOD AFTERNOON, DR. ZACHMAN.
AUDRA ZACHMAN: THANK YOU.
MR. BOSTIC: FIRST OF ALL, WE'RE BOTH WEARING MASKS RIGHT NOW. MY UNDERSTANDING FROM THE COURT IS THAT IF YOU'RE VACCINATED AND COMFORTABLE TESTIFYING WITHOUT A MASK OR WOULD PREFER TO DO SO, YOU'RE WELCOME TO REMOVE YOUR MASK.
AUDRA ZACHMAN: THANK YOU. I AM.
MR. BOSTIC: CAN YOU START BY TELLING US IF YOU'RE CURRENTLY EMPLOYED?
AUDRA ZACHMAN: I AM.
MR. BOSTIC: AND WHERE ARE YOU CURRENTLY EMPLOYED?
AUDRA ZACHMAN: SOUTHWEST CONTEMPORARY WOMEN'S CARE IN PHOENIX, ARIZONA.
MR. BOSTIC: AND WHAT KIND OF BUSINESS IS THAT?
AUDRA ZACHMAN: IT'S AN OBGYN PRACTICE.
MR. BOSTIC: AND WHAT IS YOUR POSITION THERE AT SOUTHWEST?
AUDRA ZACHMAN: I'M A NURSE PRACTITIONER.
MR. BOSTIC: AND WHAT IS A NURSE PRACTITIONER?
AUDRA ZACHMAN: IT IS A PROVIDER WHO HAS BEEN TRAINED AND LICENSED TO TAKE CARE OF PATIENTS SPECIFICALLY IN MY FIELD AND IN WOMEN'S HEALTH.
MR. BOSTIC: AND HOW DOES THE ROLE OF A NURSE PRACTITIONER COMPARE TO THE ROLE OF, SAY, A REGISTERED NURSE OR A MEDICAL DOCTOR?
AUDRA ZACHMAN: SURE. A NURSE PRACTITIONER HAS MORE EDUCATION THAN A REGISTERED NURSE, AND WE CAN WORK INDEPENDENTLY THEN, WHERE A REGISTERED NURSE WORKS UNDER THE ORDERS OF A NURSE PRACTITIONER OR A PHYSICIAN. A PHYSICIAN HAS A DIFFERENT AVENUE OF EDUCATION AS WELL, USUALLY WITH MORE YEARS SPECIALIZING IN A FIELD THAN A NURSE PRACTITIONER.
MR. BOSTIC: DO REGISTERED NURSES WORK AUTONOMOUSLY THE WAY NURSE PRACTITIONERS DO?
AUDRA ZACHMAN: NO, THEY DON'T.
MR. BOSTIC: DO NURSE PRACTITIONERS EVER SUPERVISE REGISTERED NURSES?
AUDRA ZACHMAN: YES.
MR. BOSTIC: YOU SAID THAT SOUTHWEST WAS AN OBGYN PRACTICE; IS THAT CORRECT?
AUDRA ZACHMAN: THAT'S CORRECT.
MR. BOSTIC: AND CAN YOU DESCRIBE JUST AT A HIGH LEVEL YOUR INDIVIDUAL PRACTICE AT SOUTHWEST?
AUDRA ZACHMAN: SURE. SO I SEE WOMEN FOR THEIR GYNECOLOGICAL OR OBSTETRICAL NEEDS, IF THEY ARE PREGNANT OR TRYING TO CONCEIVE OR TRYING TO PREVENT PREGNANCY OR HAVING CONCERNS RELATED TO THEIR WOMEN'S HEALTH AT AGE 13 TO 99, ANYWHERE IN THERE.
MR. BOSTIC: AND FOR HOW LONG HAVE YOU BEEN A NURSE PRACTITIONER AT SOUTHWEST?
AUDRA ZACHMAN: EIGHT YEARS.
MR. BOSTIC: IN YOUR PRACTICE DID YOU HAVE AN OPPORTUNITY TO HAVE EXPERIENCE WITH TEST RESULTS FROM A COMPANY CALLED THERANOS?
AUDRA ZACHMAN: I DID.
MR. BOSTIC: AND WAS THERE A TIME PERIOD WHEN YOU WERE USING THERANOS FOR BLOOD TESTING SERVICES FOR YOUR PATIENTS?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND I'LL ASK THIS JUST AS A YES OR NO QUESTION FOR NOW. DID THERE COME A TIME WHEN YOU DECIDED TO NO LONGER USE THERANOS FOR BLOOD TESTING SERVICES?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND HOW DID YOU FIRST HEAR ABOUT THE COMPANY THERANOS?
AUDRA ZACHMAN: IN 2014 I WAS WORKING AT SOUTHWEST, AND I WAS HEAD OF A GROUP THAT WE CREATED CALLED THE PRODUCT COMMITTEE TO BE ABLE TO WEED THROUGH THE DIFFERENT PRODUCTS THAT WOULD COME THROUGH THE OFFICE AND TRY TO GAIN OUR ATTENTION AND OUR BUSINESS, AND THERANOS WAS ONE OF THEM.
MR. BOSTIC: YOU SAID -- WAS IT CALLED THE PRODUCT COMMITTEE AT SOUTHWEST?
AUDRA ZACHMAN: THAT'S CORRECT.
MR. BOSTIC: AND DID THAT COMMITTEE ALSO EVALUATE SERVICES LIKE TESTING LABS, FOR EXAMPLE?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND HOW DID THERANOS COME TO THE ATTENTION OF THE PRODUCT COMMITTEE AT SOUTHWEST?
AUDRA ZACHMAN: A REPRESENTATIVE CAME THROUGH THE OFFICE, I'M NOT SURE WHO, AND DROPPED OFF A CARD AND WANTED TO HAVE A COUPLE OF MINUTES OF ATTENTION TO DISCUSS THAT, THERANOS AS AN OPTION. AND I WAS SEEING PATIENTS AT THE TIME SO IT WAS JUST MORE OF THE GATHERING OF THAT INFORMATION AND THAT I WOULD BE ABLE TO GET BACK TO THEM WHEN AVAILABLE.
MR. BOSTIC: AND DO YOU REMEMBER APPROXIMATELY WHEN IN TIME THAT WAS THAT FIRST CONTACT WITH SOMEONE FROM THERANOS?
AUDRA ZACHMAN: I THINK IT WAS IN THE SUMMER OF 2014.
MR. BOSTIC: AND DID THAT INITIAL CONTACT LEAD TO MORE SUBSTANTIVE DISCUSSION WITH THERANOS?
AUDRA ZACHMAN: YES. SO THEN I REACHED OUT TO THE REPRESENTATIVE VIA EMAIL TO BE ABLE TO SET UP AN APPROPRIATE TIME. WE HAD PRODUCT COMMITTEE MEETINGS WHERE WE WOULD LINE UP A PARTICULAR NUMBER OF PHARMACEUTICAL COMPANIES OR REPRESENTATIVES FROM LABORATORIES TO BE ABLE TO COME AND SHOWCASE IF YOU WILL.
MR. BOSTIC: AND DID SOMEONE FROM THERANOS END UP PRESENTING TO THE PRODUCT COMMITTEE?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WAS THAT ALSO IN THE SUMMER OF 2014?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND DID YOU AND OTHERS AT SOUTHWEST LEARN MORE ABOUT THE COMPANY AND WHAT IT WAS OFFERING AT THE TIME?
AUDRA ZACHMAN: YES. WE LEARNED THAT IT WOULD BE A GOOD OPTION FOR OUR PATIENTS. WE FELT THAT AT THE TIME THAT IT WAS SOMETHING THAT MIGHT BE MORE COST EFFECTIVE, HAVE A BETTER TURN AROUND TIME FOR LAB RESULTS, MAYBE BE LESS INVASIVE BY OFFERING A FINGERSTICK INSTEAD OF A TRADITIONAL VENOUS PUNCTURE, AND HAVE GOOD ACCESSIBILITY AS IT WAS I THINK GOING TO BE CLOSE IN PROXIMITY TO OUR OFFICE LOCATION.
MR. BOSTIC: DID YOUR ROLE ON THE PRODUCT COMMITTEE ALSO INCLUDE NOT JUST ORGANIZING THOSE PRESENTATIONS BUT ALSO EVALUATING PRESENTATIONS AND DECIDING WHETHER TO ENTER INTO PARTNERSHIPS WITH VENDORS?
AUDRA ZACHMAN: YES. SO THE PRODUCT COMMITTEE MEETINGS WHICH WERE ORCHESTRATED BY ME WERE OFFERED AS AN OPPORTUNITY FOR ALL OF THE PROVIDERS IN THE PRACTICE TO BE ABLE TO ATTEND, BUT OFTEN IT WAS DURING LUNCH HOURS AND NOT A LOT OF OUR PROVIDERS WERE. SO THEN I ALSO ACTED AS A LIAISON KIND OF CARRYING THAT INFORMATION OVER TO OUR PROVIDER MEETINGS SAYING WHAT -- KIND OF THE BULLET POINT INFORMATION THAT WAS GIVEN AT THE PRIOR MEETING AND THEN MY OPINION ABOUT IT.
MR. BOSTIC: WHEN IT CAME TO EVALUATING THERANOS FOR POTENTIAL BLOOD TESTING SERVICES, DID YOU HAVE A SENSE OF WHAT FACTORS WERE IMPORTANT TO YOUR PRACTICE IN DECIDING WHETHER TO USE THE LAB OR NOT?
AUDRA ZACHMAN: UH-HUH. I THINK IT WAS IMPORTANT TO MYSELF AND TO ALL OF THE PROVIDERS IN THE OFFICE THAT IT BE A LAB THAT WAS RELIABLE, COST EFFECTIVE, GOOD TURN AROUND TIME FOR THE RESULTS, CONVENIENT.
MR. BOSTIC: WHEN YOU SAY RELIABLE, TELL ME MORE ABOUT THAT? WHAT DOES THAT MEAN FOR A LAB TO BE RELIABLE?
AUDRA ZACHMAN: FOR THE RESULTS THAT ARE BEING RECEIVED TO BE ACCURATE IN WHAT THEY'RE REPRESENTING.
MR. BOSTIC: AND WHEN YOU'RE TALKING ABOUT DIFFERENT FACTORS THAT WERE IMPORTANT TO YOUR DECISION, WHERE DO YOU RANK KIND OF THE ACCURACY, RELIABILITY OF THE TESTS IN THAT LIST?
AUDRA ZACHMAN: I WOULD RANK IT AS MOST IMPORTANT.
MR. BOSTIC: AND WHY IS THAT?
AUDRA ZACHMAN: WELL, IF YOU RECEIVE A LAB RESULT AND YOU HAVE TO WONDER OR YOU'RE NOT SURE IF IT'S ACCURATE OR NOT, THEN ANY CLINICAL DECISIONS THAT YOU ARE GOING TO BASE OFF OF THAT RESULT ARE NULL AND VOID.
MR. BOSTIC: AND YOU'RE TALKING ABOUT DECISIONS RELATING TO PATIENT CARE?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: ULTIMATELY AROUND THAT TIME IN THE SUMMER OF 2014 DID SOUTHWEST DECIDE TO START USING THERANOS FOR BLOOD TESTING SERVICES?
AUDRA ZACHMAN: WE DID.
MR. BOSTIC: AND WAS THERE ALSO DISCUSSION AROUND THAT TIME ABOUT THERANOS SETTING UP A PRESENCE INSIDE ONE OF SOUTHWEST'S LOCATIONS?
AUDRA ZACHMAN: YES. WE HAVE THREE OFFICE LOCATIONS, SO IT'S NOT IN THE CLINIC THAT I'M BASED OUT OF, BUT IN ONE OF OUR OTHER LOCATIONS WE HAD AN OPEN LAB OFFICE RIGHT BELOW OUR PRACTICE WHERE THEY WERE ABLE TO SET UP A PRESENCE.
MR. BOSTIC: AND WHAT WAS YOUR UNDERSTANDING OF WHAT WOULD THE BENEFITS OR THE EFFECT BE OF THERANOS HAVING A PRESENCE THERE?
AUDRA ZACHMAN: UH-HUH. IT WAS MENTIONED TO BE VERY EXCITING CERTAINLY FROM A PROVIDER PERSPECTIVE TO BE ABLE TO ORDER A TEST AND JUST TELL THE PATIENT, YOU KNOW, YOU JUST WALK DOWN THESE STAIRS AND YOU CAN GET DRAWN FOR THAT. SO IT'S CONVENIENT TO THE PATIENT, BUT IT ALSO IS HELPFUL TO THE PROVIDER KNOWING THAT WHATEVER YOU'RE LOOKING FOR, WHATEVER LAB YOU WANT IS GETTING DRAWN AT THAT TIME.
MR. BOSTIC: AND DID YOU PERSONALLY SEND SOME OF YOUR PATIENTS TO GET BLOOD TESTING SERVICES AT THERANOS?
AUDRA ZACHMAN: I DID.
MR. BOSTIC: AND LET'S TALK ABOUT ONE PATIENT IN PARTICULAR. DID YOU TREAT A PATIENT NAMED BRITTANY GOULD IN YOUR PRACTICE?
AUDRA ZACHMAN: I DID.
MR. BOSTIC: AND WHEN DID MS. GOULD FIRST BECOME A PATIENT OF YOURS APPROXIMATELY?
AUDRA ZACHMAN: IN THE BEGINNING OF 2014 I SAW HER FOR ROUTINE WOMEN'S WELLNESS, AND THEN IN THE SUMMER OF 2014 I SAW HER FOR A PREGNANCY LOSS, AND AGAIN IN SEPTEMBER OF 2014.
MR. BOSTIC: YOU SAW HER AGAIN IN SEPTEMBER OF 2014?
AUDRA ZACHMAN: FOR A SUBSEQUENT PREGNANCY.
MR. BOSTIC: SO TELL US ABOUT THAT. WHAT WAS THE STATUS OF THINGS DURING THAT VISIT OF SEPTEMBER 2014?
AUDRA ZACHMAN: UH-HUH. SO I SAW BRITTANY. SHE HAD HAD A POSITIVE PREGNANCY TEST AT HOME. SHE HAD HAD PREVIOUS MISCARRIAGES, AND SO THAT VISIT WAS EARLY ON IN THE PREGNANCY AS SHE WAS WANTING TO ESTABLISH CARE EARLY, AND I WAS WANTING TO GIVE REASSURANCE TO HER AND TO US OF THE WELL BEING OF HER PREGNANCY. SO IT WAS A VISIT TO ESTABLISH, YES, SHE IS PREGNANT, AND TO LOOK AT THE HEALTH OF THE PREGNANCY.
MR. BOSTIC: AND DID THIS PATIENT'S PARTICULAR HISTORY THAT YOU MENTIONED PLAY INTO THE DECISIONS THAT YOU MADE SUBSEQUENTLY ABOUT HOW TO APPROACH THE EARLY STAGE OF THE PREGNANCY?
AUDRA ZACHMAN: ABSOLUTELY. SO SHE HAD HAD THREE MISCARRIAGES PRIOR TO OUR VISIT IN SEPTEMBER, AND IN OBSTETRICS THAT'S CONSIDERED INCURRED PREGNANCY LOSS, WHICH THAT PUTS HER INTO A HIGH RISK PREGNANCY CATEGORY, SO WE FOLLOW THOSE PREGNANCIES MORE CLOSELY, PARTICULARLY IN EARLY PREGNANCY WHERE WE WERE DRAW SERUM QUANTS TO LOOK AT THE HEALTH OF THE PREGNANCY, AN HCG QUANT.
MR. BOSTIC: AND THAT IS MY NEXT QUESTION, TOO. WHAT IS AN HCG QUANT IN THAT CONTEXT?
AUDRA ZACHMAN: SO IT'S A HORMONE THAT IS PRODUCED EARLY IN THE PREGNANCY BUT THROUGHOUT THE PREGNANCY BUT RISES IN EARLY PREGNANCY BEFORE WE'RE ABLE TO SEE VIABILITY OR FETAL WELL BEING ON AN ULTRASOUND.
MR. BOSTIC: AND DID YOU ORDER A SERIES OF HCG QUANTITATIVE TESTS FOR BRITTANY GOULD?
AUDRA ZACHMAN: I DID.
MR. BOSTIC: ONE MOMENT, YOUR HONOR. I APOLOGIZE.
(PAUSE IN PROCEEDINGS.)
MR. BOSTIC: MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
MR. BOSTIC: (HANDING.)
JUDGE DAVILA: DO YOU HAVE THIS?
MR. BOSTIC: YES, I HAVE PROVIDED A COPY TO THE DEFENSE.
JUDGE DAVILA: THANK YOU.
BY MR. BOSTIC:
MR. BOSTIC: DR. ZACHMAN, YOU HAVE A BINDER OF DOCUMENTS IN FRONT OF YOU?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND CAN I ASK YOU, PLEASE, IN THAT BINDER TO TURN TO TAB 5410. LET ME KNOW WHEN YOU'RE THERE.
AUDRA ZACHMAN: I'M THERE.
MR. BOSTIC: DO YOU RECOGNIZE THE DOCUMENT MARKED AS 5410?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND WHAT IS THAT DOCUMENT?
AUDRA ZACHMAN: IT'S AN HCG QUANT WITH A VALUE OF 1005.
MR. BOSTIC: AND IS THIS A BLOOD TEST VALUE FOR A PARTICULAR PATIENT?
AUDRA ZACHMAN: YES. SO THIS IS FOR BRITTANY GOULD.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT 5410, AND I UNDERSTAND THAT THE DEFENSE HAS STIPULATED.
MS. TREFZ: THAT'S CORRECT, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. IT'S ADMITTED.
(GOVERNMENT'S EXHIBIT 5410 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MAY WE PUBLISH?
JUDGE DAVILA: YES.
MR. BOSTIC: MS. HOLLIMAN, LET'S DISPLAY 5410, PLEASE. AND IF WE CAN ZOOM IN ON THE TOP HALF.
MR. BOSTIC: DR. ZACHMAN, CAN YOU JUST WALK US THROUGH WHAT WE'RE LOOKING AT HERE?
AUDRA ZACHMAN: SURE. SO THIS IS BRITTANY'S HCG VALUE DRAWN ON SEPTEMBER 30TH OF 2014 BY QUEST DIAGNOSTICS. IT'S SHOWING, AGAIN, THAT IT'S 1005, WHICH CONFIRMS A POSITIVE PREGNANCY STATUS.
MR. BOSTIC: SORRY. LET ME ASK FIRST, THE DATE OF THIS DRAW WAS SEPTEMBER 30TH, 2014. IS THAT WHAT IS INDICATED HERE?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WHEN WAS THAT DATE IN RELATION TO YOUR FIRST VISIT WHEN MS. GOULD CAME IN WITH THE INITIAL REPORT OF A PREGNANCY?
AUDRA ZACHMAN: I'M NOT CERTAIN. I WOULD THINK THAT I WOULD HAVE HAD IT DRAWN THE DAY OF OR AT LEAST ORDERED IT THAT DAY.
MR. BOSTIC: OKAY. LET'S MOVE NEXT TO EXHIBIT 2044. YOUR HONOR, I WOULD MOVE THIS ONE INTO EVIDENCE AS WELL. IT'S ALSO SUBJECT TO STIPULATION.
MS. TREFZ: THAT'S CORRECT, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. IT'S ADMITTED. IT MAY BE PUBLISHED. THANK YOU.
(GOVERNMENT'S EXHIBIT 2044 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ZACHMAN, DO YOU SEE EXHIBIT 2044 IN FRONT OF YOU?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: WHAT IS EXHIBIT 2044, FIRST LOOKING AT PAGE 1?
AUDRA ZACHMAN: SO THIS IS ANOTHER QUANT VALUE DRAWN TWO DAYS LATER ON OCTOBER 2ND SHOWING A VALUE OF 12,558.
MR. BOSTIC: FOR NOW WE'LL JUST GO THROUGH THE RESULTS AND THEN LATER I'LL ASK YOU FOR WHAT THEY SIGNIFIED TO YOU?
AUDRA ZACHMAN: SURE.
JUDGE DAVILA: MR. BOSTIC, BEFORE WE GO FURTHER, I'D ASK THAT THE PHONE NUMBER OF THE PATIENT BE REDACTED IF THAT'S, IF THAT'S THERE. THAT SHOULD BE REDACTED BEFORE IT'S ENTERED INTO EVIDENCE, PLEASE.
MR. BOSTIC: YOUR HONOR, I BELIEVE IT IS REDACTED ON THE VERSION THAT IS DISPLAYING ON THE SCREEN RIGHT NOW, AND WE'LL MAKE SURE THAT IT'S -- I DO SEE A PHONE NUMBER FOR THE PRACTICE ITSELF.
JUDGE DAVILA: I SEE.
MR. BOSTIC: THAT'S FOR THE PHYSICIAN.
JUDGE DAVILA: THAT'S FOR THE PHYSICIAN.
MR. BOSTIC: THAT'S MY UNDERSTANDING.
JUDGE DAVILA: THANK YOU.
MR. BOSTIC: THANK YOU, YOUR HONOR.
MR. BOSTIC: DR. ZACHMAN, THE PREVIOUS LAB THAT WE LOOKED AT WAS FROM A LAB CALLED SONORA QUEST; IS THAT CORRECT?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WHAT LAB PROVIDED THE RESULT THAT WE'RE LOOKING AT HERE?
AUDRA ZACHMAN: THERANOS.
MR. BOSTIC: AND AGAIN, THE DATE OF THIS LAB RESULT?
AUDRA ZACHMAN: THE SECOND OF OCTOBER.
MR. BOSTIC: OKAY. AND, MS. HOLLIMAN, LET'S GO TO PAGE 2 OF EXHIBIT 2044. AGAIN, LET'S ZOOM IN ON THE TOP HALF. DR. ZACHMAN, DO YOU SEE PAGE 2 OF EXHIBIT 2044?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND WHAT ARE WE LOOKING AT HERE?
AUDRA ZACHMAN: ANOTHER QUANT VALUE DRAWN TWO DAYS LATER ON THE 4TH OF OCTOBER 2014 FOR THE SAME PATIENT SHOWING THE RESULTS OF 125.58 ALSO DRAWN AT THERANOS?
MR. BOSTIC: LET'S MOVE NEXT TO EXHIBIT 3305. YOUR HONOR, I WOULD ALSO MOVE THIS INTO EVIDENCE SUBJECT TO STIPULATION?
MS. TREFZ: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 3305 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN ZOOM IN ON THE TOP HALF.
MR. BOSTIC: DR. ZACHMAN, ARE YOU LOOKING AT ANOTHER LAB TEST RESULT FOR MS. GOULD?
AUDRA ZACHMAN: I AM.
MR. BOSTIC: AND WHAT WAS THE DATE OF THIS SAMPLE?
AUDRA ZACHMAN: THE 6TH OF OCTOBER, 2014.
MR. BOSTIC: SO TWO DAYS AFTER THE LAST SAMPLE THAT WE JUST LOOKED AT?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: AND WHAT PROVIDER RAN THIS TEST?
AUDRA ZACHMAN: QUEST DIAGNOSTICS.
MR. BOSTIC: AND WHAT WAS THE HCG VALUE FOR MS. GOULD ON THIS DATE?
AUDRA ZACHMAN: 9559.
MR. BOSTIC: OKAY. THANK YOU. FINALLY, LET'S LOOK AT EXHIBIT 5411, PLEASE, WHICH I WOULD ALSO OFFER INTO EVIDENCE SUBJECT TO THE DEFENSE STIPULATION.
MS. TREFZ: THAT'S CORRECT.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5411 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ZACHMAN, FINALLY, DO YOU SEE YET ANOTHER LAB RESULT REPORT FOR YOUR PATIENT BRITTANY GOULD ON THE SCREEN?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND WHAT WAS THE DATE WHEN THIS SAMPLE WAS DRAWN?
AUDRA ZACHMAN: THE 8TH OF OCTOBER.
MR. BOSTIC: TWO DAYS AFTER THE LAST DRAW?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: AND WHAT WAS THE LAB PROVIDING THIS RESULT?
AUDRA ZACHMAN: QUEST DIAGNOSTICS.
MR. BOSTIC: IS THAT THE SAME THING AS SONORA QUEST?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WHAT WAS THE HCG VALUE ON THIS DATE?
AUDRA ZACHMAN: 17,716.
MR. BOSTIC: WE'LL CIRCLE BACK TO THOSE RESULTS IN A MOMENT. FOR NOW LET ME ASK, WHAT WAS THE ULTIMATE OUTCOME OF MS. GOULD'S PREGNANCY?
AUDRA ZACHMAN: SHE HAD A SUCCESSFUL VIABLE PREGNANCY.
MR. BOSTIC: SHE CARRIED HER BABY TO TERM AND THE BIRTH WAS SUCCESSFUL?
AUDRA ZACHMAN: YES.
MR. BOSTIC: GOOD. I'D LIKE TO ASK YOU ABOUT CONCLUSIONS THAT YOU REACHED BASED ON THE RESULTS THAT WE JUST LOOKED AT. BUT FIRST LET ME ASK YOU A FEW MORE QUESTIONS ABOUT YOUR BACKGROUND AND QUALIFICATIONS.
AUDRA ZACHMAN: SURE.
MR. BOSTIC: FIRST, CAN YOU SUMMARIZE FOR US YOUR EDUCATION BEGINNING WITH COLLEGE, PLEASE?
AUDRA ZACHMAN: SURE. I HAVE AN UNDERGRADUATE AS A BACHELOR OF NURSING AND A GRADUATE DEGREE AS A DOCTOR OF NURSING PRACTICE IN WOMEN'S HEALTH.
MR. BOSTIC: AND FROM WHERE DID YOU OBTAIN THOSE DEGREES?
AUDRA ZACHMAN: BOTH FROM ARIZONA STATE UNIVERSITY.
MR. BOSTIC: HOW ABOUT YOUR PROFESSIONAL EXPERIENCE FOLLOWING YOUR EDUCATION? CAN YOU GIVE US AN OVERVIEW OF THAT?
AUDRA ZACHMAN: SURE. SO ONCE I GRADUATED FROM MY UNDERGRADUATE I BECAME A NURSE, A REGISTERED NURSE WORKING IN LABOR AND DELIVERY AND ANTEPARTUM AND POSTPARTUM OBSTETRICAL UNITS IN THE HOSPITAL. AND THEN I WENT BACK TO SCHOOL AND GRADUATED WITH MY DOCTORATE AND HAVE BEEN WORKING AS A NURSE PRACTITIONER AT SOUTHWEST CONTEMPORARY WOMEN'S CARE SINCE THEN.
MR. BOSTIC: DO YOU HOLD ANY PROFESSIONAL LICENSES?
AUDRA ZACHMAN: I DO. YOU HAVE TO STAY UP TO DATE ON YOUR RN AND YOUR NP LICENSE, AND THAT REQUIRES CONTINUING EDUCATION AND HANDS-ON PATIENT CARE AND RENEWAL OF LICENSURE.
MR. BOSTIC: AND HAVE YOU COMPLIED WITH THOSE RENEWAL REQUIREMENTS OVER THE YEARS?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND ARE YOUR LICENSES CURRENTLY ACTIVE?
AUDRA ZACHMAN: YES.
MR. BOSTIC: IN THE COURSE OF YOUR EDUCATION THAT YOU JUST SUMMARIZED, DID YOU LEARN ABOUT HCG?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WHAT IS HCG?
AUDRA ZACHMAN: IT'S A HORMONE THAT IS PRODUCED IN EARLY PREGNANCY SHOWING A POSITIVE PREGNANCY STATUS AND CAN HELP TO DETERMINE THE OUTCOME OF A PREGNANCY.
MR. BOSTIC: SINCE GRADUATING IN YOUR MEDICAL PRACTICE, HAVE YOU HAD EXPERIENCE WITH HCG TESTS AND INTERPRETING THE RESULTS OF THOSE TESTS?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND CAN YOU DESCRIBE THAT EXPERIENCE? HOW FREQUENTLY HAVE YOU WORKED WITH HCG TESTS, FOR EXAMPLE?
AUDRA ZACHMAN: SO IT'S A VERY COMMON TEST TO ORDER IN PREGNANCY, CERTAINLY MORE COMMON TO ORDER, LIKE I WAS SAYING, IN A PATIENT WHO HAS A HISTORY OF PREGNANCY LOSS OR WHERE WE HAVE CONCERN OF HOW THE PREGNANCY IS GOING. I WOULD SAY THAT I HAVE LOOKED AT THOUSANDS OVER THE YEARS.
MR. BOSTIC: AND HOW DO YOU ARRIVE AT THAT NUMBER? HOW DO YOU ESTIMATE THE QUANTITY OF HCG RESULTS THAT YOU'VE REVIEWED?
AUDRA ZACHMAN: I HAVE SEEN, YOU KNOW, 20 PATIENTS ON AVERAGE A DAY WORKING FOR THE PAST 8 YEARS. LET'S SAY HALF OF THEM ARE PREGNANT. AND THAT IN MY PRACTICE SPECIFICALLY THAT CAN -- EARLY PREGNANCIES COME TO THE NURSE PRACTITIONERS OFTEN AND THE LEADER IN PREGNANCY, THE PHYSICIANS SEE THEM PRIOR TO DELIVERY. SO IF I'M GUESSTIMATING THE MATH ON THAT.
MR. BOSTIC: AND YOU ESTIMATED THAT THE TOTAL NUMBER OF HCG RESULTS THAT YOU'VE REVIEWED IN YOUR PRACTICE HAS BEEN IN THE THOUSANDS?
AUDRA ZACHMAN: I WOULD SAY SO.
MR. BOSTIC: YOUR HONOR, AT THIS TIME THE GOVERNMENT WOULD OFFER DR. ZACHMAN TO GIVE EXPERT TESTIMONY IN THE AREA OF INTERPRETING HUMAN HCG TEST RESULTS.
MS. TREFZ: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU. LADIES AND GENTLEMEN, SOME WITNESSES BECAUSE OF EDUCATION OR EXPERIENCE ARE PERMITTED TO STATE OPINIONS AND THE REASONS FOR THOSE OPINIONS. THIS TESTIMONY SHOULD BE JUDGED LIKE ANY OTHER TESTIMONY, YOU MAY ACCEPT IT OR REJECT IT, AND GIVE IT AS MUCH WEIGHT AS YOU THINK IT DESERVES CONSIDERING THE WITNESS'S EDUCATION AND EXPERIENCES, THE REASONS GIVEN FOR THE OPINION, AND ALL OF THE OTHER EVIDENCE IN THE CASE. YOU WILL RECEIVE A FINAL INSTRUCTION ALSO AS TO HOW YOU MAY CONSIDER THIS EVIDENCE. SO THIS WITNESS MAY BE PERMITTED TO TESTIFY AS AN EXPERT ON THESE ISSUES.
MR. BOSTIC: THANK YOU, YOUR HONOR.
MR. BOSTIC: DR. ZACHMAN, YOU TESTIFIED THAT HCG LEVELS WERE RELEVANT TO PREGNANCY STATUS; IS THAT CORRECT?
AUDRA ZACHMAN: THAT'S CORRECT.
MR. BOSTIC: AND CAN YOU EXPLAIN FOR US HOW THAT'S THE CASE AND WHAT LEVELS YOU EXPECT TO SEE IN A HEALTHY PREGNANCY?
AUDRA ZACHMAN: SURE. SO YOU ANTICIPATE TO SEE HCG VALUES DOUBLE EVERY 48 TYPICALLY BUT CAN BE UP TO EVERY 72 HOURS IN EARLY PREGNANCY.
MR. BOSTIC: AND AS PART OF YOUR PRACTICE DO YOU FREQUENTLY ORDER A SERIES OF HCG TESTS TO TRACK THAT TREND?
AUDRA ZACHMAN: YES. A SINGLE VALUE DOESN'T HOLD A LOT OF WEIGHT TO US TYPICALLY. IT'S MORE THE TREND THAT WE SEE OVER TWO, THREE, MAYBE FOUR DRAWS.
MR. BOSTIC: ONE MOMENT AGAIN, YOUR HONOR. MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
MR. BOSTIC: (HANDING.)
AUDRA ZACHMAN: THANK YOU.
BY MR. BOSTIC:
MR. BOSTIC: DR. ZACHMAN, I'VE JUST HANDED YOU A DEMONSTRATIVE EXHIBIT. I'LL ASK YOU TO TAKE A LOOK AT IT AND LET ME KNOW IF THE EXHIBIT THAT I'VE HANDED TO YOU CORRECTLY SUMMARIZES THE TEST VALUES THAT WE JUST LOOKED AT FOR BRITTANY GOULD?
AUDRA ZACHMAN: YES.
MR. BOSTIC: OKAY. YOUR HONOR, MAY WE PUBLISH THIS DEMONSTRATIVE UNDER RULE 611?
MS. TREFZ: NO OBJECTION.
JUDGE DAVILA: IT MAY BE PUBLISHED. THANK YOU.
BY MR. BOSTIC:
MR. BOSTIC: DR. ZACHMAN, DO YOU SEE THE LISTING IN FRONT OF YOU BRITTANY GOULD'S HCG VALUES?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND CAN YOU GO THROUGH THESE ONE BY ONE AND TELL ME WHAT SIGNIFICANCE THEY HELD FOR YOU AS A PRACTITIONER AT THE TIME? LET'S START WITH THE SEPTEMBER 30TH, 2014, RESULT. FIRST OF ALL, WHAT DID THAT VALUE OF 1005 TELL YOU ABOUT THE PREGNANCY STATUS ON THAT DATE?
AUDRA ZACHMAN: MERELY THAT SHE IS PREGNANT.
MR. BOSTIC: AND WHAT VALUE WOULD YOU EXPECT TO SEE HAD MS. GOULD NOT BEEN PREGNANT ON THAT DATE?
AUDRA ZACHMAN: LESS THAN 5.
MR. BOSTIC: AT THAT TIME DID YOU MAKE A DECISION TO KEEP HAVING MS. GOULD GET HCG TESTS?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WHY DID YOU MAKE THAT DECISION?
AUDRA ZACHMAN: TO FOLLOW THE TREND OF THE HCG'S TO CONFIRM THAT IT WAS MOVING IN A DIRECTION OF A VIABLE PREGNANCY.
MR. BOSTIC: DID YOU DECIDE WHERE MS. GOULD WENT FOR HER HCG TESTS, IN OTHER WORDS, WHETHER SHE WENT TO SONORA QUEST OR TO THERANOS?
AUDRA ZACHMAN: I ENCOURAGED HER TO GO TO THERANOS.
MR. BOSTIC: AND WHY WAS THAT?
AUDRA ZACHMAN: UM, IT WAS CONVENIENT AND FOR SOMEBODY WHO IS BEING DRAWN REPEATEDLY, IF IT WAS AN OPPORTUNITY TO BE LESS INVASIVE, THAT WAS ENTICING.
MR. BOSTIC: LET'S LOOK AT THAT FIRST THERANOS RESULT THEN. THIS IS OCTOBER 2ND, 2014; IS THAT CORRECT?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND SO TWO DAYS AFTER THE SEPTEMBER 30TH DRAW. AND THE RESULT ON THAT DATE WAS 12,558 FOR HCG; IS THAT RIGHT?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WHAT WAS THE SIGNIFICANCE OF THAT VALUE TO YOU AT THE TIME?
AUDRA ZACHMAN: THAT IS MUCH HIGHER THAN I WOULD ANTICIPATE IN A ROUTINE PREGNANCY.
MR. BOSTIC: AND YOU TESTIFIED BEFORE THAT YOU WOULD EXPECT IN A HEALTHY PREGNANCY HCG VALUES TO DOUBLE EVERY 48 HOURS?
AUDRA ZACHMAN: THAT'S CORRECT.
MR. BOSTIC: AND SO WHAT VALUE WOULD YOU EXPECT TO SEE?
AUDRA ZACHMAN: MAYBE 25,000 OR 2500 DEPENDING ON THE TIME OF DAY SHE WAS DRAWN.
MR. BOSTIC: LET'S MOVE TO THE SECOND THERANOS RESULT. THAT'S ON OCTOBER 4TH, 2014; CORRECT?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WHAT WAS THE VALUE FOR MS. GOULD'S HCG ON THAT DATE ACCORDING TO THERANOS?
AUDRA ZACHMAN: 125.
MR. BOSTIC: AND WHAT DID THAT RESULT MEAN TO YOU WHEN YOU FIRST RECEIVED IT?
AUDRA ZACHMAN: SO THAT IS A SIGNIFICANT DROP FROM THE PRIOR RESULT WHICH WOULD BE VERY CONCERNING TO THE PREGNANCY. IT WOULD INDICATE A THREATENED ABORTION OR POTENTIALLY A COMPLETE LOSS OF THE PREGNANCY.
MR. BOSTIC: AND IS THAT TRUE EVEN THOUGH -- I NOTE THAT THIS VALUE IS STILL ABOVE 25. SO CAN YOU TELL US MORE ABOUT THAT? WHY WOULD THIS NUMBER BE A RED FLAG FOR YOU?
AUDRA ZACHMAN: YES. SO WHEN WE, WHEN WE SEE A NUMBER -- AN HCG THAT HAS SUCH A SIGNIFICANT DROP THEN WE SEE THAT ONLY IN LOSSES, ONLY IN PREGNANCY LOSSES. BEING THAT IT IS SO LOW, IT WOULD -- AND THAT IT DIDN'T JUST GO DOWN BY A FEW VALUES, IT WOULD SUGGEST THAT THE BODY HAS ALREADY STARTED TO ELIMINATE SOME OF THE HORMONE THEN.
MR. BOSTIC: JUST TO BE CLEAR, IN YOUR EXPERIENCE OF TREATING PATIENTS AND HCG RESULTS, HAVE YOU EVER SEEN THIS KIND OF DROP IN CONNECTION WITH A HEALTHY OR VIABLE PREGNANCY?
MR. BOSTIC: ANYTHING CLOSE TO THIS KIND OF DROP IN A HEALTHY OR VIABLE PREGNANCY?
MR. BOSTIC: WHEN YOU RECEIVED THIS RESULT -- WELL, LET ME ASK, DID YOU RECEIVE THIS TEST RESULT ON APPROXIMATELY OCTOBER 4TH, 2014?
AUDRA ZACHMAN: I BELIEVE I DID, ALTHOUGH I DON'T REMEMBER.
MR. BOSTIC: AND DO YOU REMEMBER WHAT ACTION YOU TOOK, IF ANY, WHEN YOU FIRST RECEIVED THIS RESULT?
AUDRA ZACHMAN: I REMEMBER COMMUNICATING TO BRITTANY THAT IT WAS LOOKING AS THOUGH THIS WAS A NONVIABLE PREGNANCY, WHICH WOULD MAKE IT HER FOURTH LOSS, AND I WAS WANTING TO REACH OUT TO HER TO SEE IF SHE HAD ALREADY EXPERIENCED EVIDENCE OF A LOSS OF PREGNANCY.
MR. BOSTIC: AND WHAT INFORMATION DID YOU GET BACK FROM MS. GOULD IN RESPONSE TO THAT QUESTION?
AUDRA ZACHMAN: THAT, NO, SHE HADN'T EXPERIENCED ANY SYMPTOMS OF A LOSS OF PREGNANCY; THAT THERE WAS NO MEDICAL INTERVENTION THAT NEEDED TO TAKE PLACE FOR HER WELL BEING; AND SURPRISE, SADNESS.
MR. BOSTIC: DID YOU MAKE A DECISION AT THAT POINT TO CONTINUE WITH PERIODIC HCG TESTING?
AUDRA ZACHMAN: YES. IN PREGNANCY LOSSES WE NEED TO CONFIRM THAT ALL OF THE PREGNANCY TISSUE HAS BEEN ELIMINATED FROM THE BODY, SO WE FOLLOW THE HCG'S BACK DOWN TO LESS THAN 5.
MR. BOSTIC: AND IS THAT WHAT YOU WERE EXPECTING TO SEE IN THOSE CONTINUED HCG TESTS?
AUDRA ZACHMAN: YES.
MR. BOSTIC: THE NEXT TEST FOR MS. GOULD WAS ON OCTOBER 6TH, 2014; IS THAT CORRECT?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: AND THE TEST WAS PERFORMED BY WHICH LAB?
AUDRA ZACHMAN: SONORA.
MR. BOSTIC: AND WHAT WAS THE HCG VALUE ON THAT DATE?
AUDRA ZACHMAN: 9559.
MR. BOSTIC: IS THIS WHAT YOU WERE EXPECTING TO SEE BASED ON THE THERANOS RESULTS?
MR. BOSTIC: AND EXPLAIN WHY NOT?
AUDRA ZACHMAN: THERE ISN'T A MEDICAL EXPLANATION IN A PREGNANCY LOSS FOR THE VALUE TO GO FROM THE HUNDREDS WAY BACK INTO THE THOUSANDS OR TO GO UP AT ALL REALLY.
MR. BOSTIC: THE FOLLOWING RESULT WAS ANOTHER TWO DAYS LATER; IS THAT CORRECT?
AUDRA ZACHMAN: THAT'S CORRECT.
MR. BOSTIC: ON OCTOBER 8TH, 2014, DID SONORA QUEST PROVIDE ANOTHER HCG VALUE FOR MS. GOULD?
AUDRA ZACHMAN: THEY DID.
MR. BOSTIC: AND WHAT WAS THAT VALUE?
AUDRA ZACHMAN: 17,716.
MR. BOSTIC: AND LOOKING AT THOSE LAST TWO SONORA QUEST VALUES, WHAT DID THEY SIGNAL TO YOU AS A MEDICAL PROFESSIONAL?
AUDRA ZACHMAN: SO THAT'S A MERE DOUBLE WITHIN 48 HOURS SUGGESTING THAT THE PREGNANCY IS MOVING IN A VIABLE WAY.
MR. BOSTIC: AND I THINK YOU TESTIFIED EARLIER THAT WE KNOW THIS STORY HAS A HAPPY ENDING AND MS. GOULD CARRIED HER PREGNANCY TO TERM?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND BASED ON THAT INFORMATION, DID YOU REACH A CONCLUSION ABOUT THE ACCURACY OF THE THERANOS TEST RESULTS?
AUDRA ZACHMAN: I FELT VERY UNCERTAIN OF THE VALIDITY OF THE RESULTS AND FELT UNCOMFORTABLE AS A PROVIDER CONTINUING TO HAVE MY PATIENTS DRAWN THERE.
MR. BOSTIC: LET'S LOOK FIRST AT THAT SECOND RESULT, THE 125.58. DO YOU SEE THAT?
AUDRA ZACHMAN: YES.
MR. BOSTIC: TELL US ABOUT WHETHER YOUR VIEW OF WHETHER THAT VALUE COULD HAVE MATCHED THE TRUE VALUE OF HCG IN MS. GOULD AT THAT TIME?
AUDRA ZACHMAN: I DO NOT FEEL THAT THAT'S -- THAT THERE'S A CLINICAL EXPLANATION FOR WHY SHE WOULD HAVE A VALUE IN THE HUNDREDS WHEN IT IS RISING APPROPRIATELY OTHERWISE.
MR. BOSTIC: AND AGAIN, WHY IS THAT?
AUDRA ZACHMAN: WELL, RETROSPECTIVELY WE KNOW THAT SHE DID HAVE A VERY SUCCESSFUL PREGNANCY. AND SEEING THAT THE FIRST VALUE CONFIRMED THAT SHE WAS PREGNANT, AND THE FOURTH AND FIFTH VALUES ROSE APPROPRIATELY, WE WOULD ANTICIPATE TO SEE THE SECOND AND THIRD VALUES SITTING IN AS DOUBLING BETWEEN THERE.
MR. BOSTIC: AND IGNORING THAT SECOND THERANOS VALUE?
AUDRA ZACHMAN: UH-HUH.
MR. BOSTIC: SO PUTTING ASIDE THE 125?
AUDRA ZACHMAN: UH-HUH.
MR. BOSTIC: WHAT CONCLUSIONS, IF ANY, WOULD YOU DRAW FROM A DROP FROM ABOUT 12,000 DOWN TO 9,000 OVER FOUR DAYS?
AUDRA ZACHMAN: YEAH, THE SAME. THAT'S SUSPICIOUS FOR A PREGNANCY LOSS.
MR. BOSTIC: AND WOULD THAT BE A SIMILAR RED FLAG IN YOUR VIEW?
AUDRA ZACHMAN: YES. YEAH.
MR. BOSTIC: WE'LL PUT THAT ASIDE FOR NOW. ACTUALLY, I'M SORRY. ONE MORE QUESTION ON THESE RESULTS. IF YOU PUT ASIDE BOTH THERANOS RESULTS, SO THE 12,500 AND THE 125, DO THE SONORA QUEST RESULTS MAKE SENSE AS A WHOLE BASED ON YOUR UNDERSTANDING OF HOW THESE LEVELS WORK?
AUDRA ZACHMAN: THEY DO.
MR. BOSTIC: AND COULD YOU EXPLAIN THAT?
AUDRA ZACHMAN: YES. SO IF SHE HAD BEEN ON VACATION AND WASN'T DRAWN ON THE SECOND AND THE FOURTH, THEN WE ONLY HAVE THE FOURTH AND FIFTH, THE SONORA QUEST VALUES, TO LOOK AT AT THE TIME, WE WOULD BE EXPECTING HER TO GO FROM A THOUSAND TO 2,000 OR 2500 TO ABOUT 4000, 5,000, TO 9,000 TO 17,000. SO IT FITS THE PICTURE WELL FOR A VIABLE PREGNANCY.
MR. BOSTIC: THE SONORA QUEST RESULTS DO?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: AND DID THAT GIVE YOU REASON TO DOUBT BOTH OF THE THERANOS TEST RESULTS IN THIS CASE?
AUDRA ZACHMAN: YES.
MR. BOSTIC: YOU TESTIFIED EARLIER ABOUT THE NUMBER OF HCG RESULTS YOU HAVE REVIEWED DURING YOUR CAREER?
AUDRA ZACHMAN: UH-HUH.
MR. BOSTIC: IN THE COURSE OF YOUR EXPERIENCE REVIEWING THOSE THOUSANDS OF HCG RESULTS, HAVE YOU EVER ENCOUNTERED AN ISSUE LIKE THIS BEFORE REGARDING TEST ACCURACY?
AUDRA ZACHMAN: I HAVEN'T.
MS. TREFZ: OBJECTION, YOUR HONOR. MOVE TO STRIKE. FOUNDATION.
JUDGE DAVILA: I THINK THAT WAS ASKED AND ANSWERED ACTUALLY. I THINK SHE TESTIFIED ABOUT THAT. SO I'LL STRIKE THIS LAST ANSWER, LADIES AND GENTLEMEN. YOU CAN ASK ANOTHER QUESTION.
MR. BOSTIC: I'M HAPPY TO LAY SOME ADDITIONAL FOUNDATION, YOUR HONOR.
JUDGE DAVILA: SURE.
BY MR. BOSTIC:
MR. BOSTIC: DR. ZACHMAN, WHAT MAKES YOU SURE THAT IN YOUR EXPERIENCE THIS IS THE ONLY ISSUE LIKE THIS THAT YOU HAVE ENCOUNTERED? HOW CAN YOU KNOW?
AUDRA ZACHMAN: THIS CIRCUMSTANCE WAS VERY IMPACTFUL TO ME AS IT STOOD OUT AS SUCH A RED FLAG FOR THE PREGNANCY THAT I HAVE SEEN, OF COURSE MANY PREGNANCY LOSSES OR SUCCESSFUL PREGNANCIES OR ANYTHING IN BETWEEN, BUT IN THOSE CASES THE HCG HAVE ALWAYS FALLEN WHERE WE ANTICIPATE THEM TO.
MR. BOSTIC: DO YOU THINK YOU WOULD HAVE REMEMBERED HAD YOU ENCOUNTERED ANOTHER RED FLAG DISCREPANCY LIKE THE ONE WE HAVE BEEN TALKING ABOUT?
AUDRA ZACHMAN: I THINK THAT I WOULD.
MR. BOSTIC: LET'S ASK YOU, DR. ZACHMAN, DO YOU HAVE EXHIBIT 4242 IN THE BINDER IN FRONT OF YOU?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: TAKE A LOOK AT THAT, AND I'LL ASK YOU TO NOTE THE DATE IN THE BOTTOM RIGHT HAND OF THE PAGE. I'LL ASK YOU IF YOU RECOGNIZE WHAT THAT DOCUMENTS IS?
AUDRA ZACHMAN: IT'S A CORRECTED AND IN PARENTHESIS A CORRECTED HCG RESULTS FROM 12-8 -- I'M SORRY, 10-8-2014.
MR. BOSTIC: AND FROM WHICH LAB IS THIS RESULT?
AUDRA ZACHMAN: FROM THERANOS.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES TO ADMIT EXHIBIT 4242.
MS. TREFZ: NO OBJECTION.
JUDGE DAVILA: I THINK BEFORE IT'S PUBLISHED, THIS DOES -- AT LEAST THE COPY I HAVE IS NOT REDACTED. IS THE PUBLIC COPY REDACTED?
MR. BOSTIC: YES, YOUR HONOR. IT'S MY UNDERSTANDING THE COPY WE'LL PROJECT DOES HAVE THE PHONE NUMBER AND THE EMAIL ADDRESS AND DATE OF BIRTH REDACTED.
JUDGE DAVILA: THANK YOU. IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4242 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: THANK YOU, YOUR HONOR.
MR. BOSTIC: DR. ZACHMAN, ARE YOU SEEING THAT LAB REPORT IN FRONT OF YOU?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AT THE TOP RIGHT OF THE PAGE THERE'S A DATE SHOWING WHEN THIS SAMPLE WAS TAKEN; IS THAT CORRECT?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: AND WHAT DATE IS THAT?
AUDRA ZACHMAN: THE 4TH OF OCTOBER.
MR. BOSTIC: AND DO YOU RECALL THAT THAT'S THE DATE -- OR LET ME ASK, WHAT WAS THE ORIGINAL HCG VALUE REPORTED BY THERANOS ON THAT DATE, OCTOBER 4TH?
AUDRA ZACHMAN: I THINK IT WAS 12,000. I HAVE IT HERE. I'M SORRY, THAT WAS THE 125.58.
MR. BOSTIC: OKAY. THE VALUE ON THIS VERSION SAYS 12,558; IS THAT CORRECT?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: AND SO THAT'S A DIFFERENT VALUE NOW BEING REPORTED?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: MS. HOLLIMAN, LET'S ZOOM OUT AND ZOOM IN ON THE BOTTOM RIGHT CORNER OF THIS PAGE. DR. ZACHMAN, DO YOU SEE A REPORT DATE INDICATED HERE?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND WHAT IS THAT DATE INDICATED?
AUDRA ZACHMAN: THE 8TH --
MR. BOSTIC: OKAY.
AUDRA ZACHMAN: -- OF OCTOBER.
MR. BOSTIC: AND SO THIS WOULD HAVE BEEN SEVERAL DAYS AFTER THE ORIGINAL DRAW HAPPENED?
AUDRA ZACHMAN: CORRECT.
MR. BOSTIC: DO YOU RECALL GETTING A CORRECTED VALUE FROM THERANOS FOR THIS HCG RESULT?
AUDRA ZACHMAN: I REMEMBER THERE BEING CONVERSATION ABOUT CORRECTING THE REPORT WHEN I VOICED CONCERN ABOUT IT, BUT I REMEMBER NOT GAINING A LOT OF TRUST BACK AFTER THAT.
MR. BOSTIC: OKAY. I'LL ASK YOU A FEW MORE QUESTIONS ABOUT THAT IN A MOMENT. FOR NOW, LET'S LOOK BRIEFLY AT THE DEMONSTRATIVE AGAIN. I'LL ASK YOU A FINAL QUESTION ABOUT THIS, WHICH IS IF WE LOOK AT THAT OCTOBER 4TH, 2014, RESULT AND REPLACE IT WITH 12,558 AS REPORTED IN THE CORRECTED LAB REPORT --
AUDRA ZACHMAN: UH-HUH.
MR. BOSTIC: -- FIRST OF ALL, WHAT DO YOU NOTE ABOUT THAT NUMBER AS COMPARED TO THE OCTOBER 2ND, 2014 RESULT?
AUDRA ZACHMAN: IN THIS VERSION I NOTE THAT THERE'S A DECIMAL POINT, WHICH IS ODD FOR HCG QUANTS, THEY'RE NOT USUALLY REPORTED TO THAT EXTENT. AND THEN IN THE CORRECTED VERSION I NOTE THAT THEY'RE THE SAME NUMBER.
MR. BOSTIC: AND THE EXACT SAME NUMBER?
AUDRA ZACHMAN: EXACT SAME.
MR. BOSTIC: AND WOULD THAT BE UNUSUAL BASED ON YOUR EXPERIENCE AS A MEDICAL PROFESSIONAL?
AUDRA ZACHMAN: YES, PARTICULARLY IN A VIABLE PREGNANCY.
MR. BOSTIC: AND WHAT, IF ANYTHING, WOULD THAT INDICATE TO YOU IF HCG LEVELS STAYED EXACTLY THE SAME OVER THAT TWO DAY PERIOD?
AUDRA ZACHMAN: NOTHING REASSURING. SOMETIMES WE SEE THAT IN ECTOPIC PREGNANCY BUT NOT WITH VALUES THIS HIGH. IT WOULD STILL MAKE ME QUESTION WHAT IS GOING ON IN HER PREGNANCY.
MR. BOSTIC: SO EVEN REPLACING THIS VALUE, THE 125, WITH THE CORRECTED VALUE, YOU WOULD STILL VIEW THAT AS A SIGN OF TROUBLE WITH THE PREGNANCY?
AUDRA ZACHMAN: YES.
MR. BOSTIC: THANK YOU FOR THAT. I'LL NOW JUST ASK YOU SOME ADDITIONAL FACTUAL QUESTIONS ABOUT YOUR EXPERIENCE WITH THE COMPANY.
AUDRA ZACHMAN: OKAY.
MR. BOSTIC: WERE YOU IN CONTACT WITH ANYONE AT THERANOS FOLLOWING THE RECEIPTS OF THESE RESULTS?
AUDRA ZACHMAN: YES. I CALLED TO FILE A COMPLAINT OR TO BRING INTO QUESTION THE VALUES THAT I HAVE BEEN GIVEN ON BRITTANY.
MR. BOSTIC: AND DO YOU REMEMBER ANYTHING ABOUT THAT CONVERSATION?
AUDRA ZACHMAN: I REMEMBER THAT I CALLED AND MAYBE SPOKE TO SOMEONE MAYBE IN HR WAS THE FEELING THAT I GOT AND THAT THEY WOULD GET BACK TO ME, AND THEN THERE WAS SOME EMAIL CORRESPONDENCE SHORTLY THEREAFTER TO EXPLAIN WHERE THE ERROR WAS.
MR. BOSTIC: I'LL ASK YOU TO LOOK IN YOUR BINDER, PLEASE, AT EXHIBIT 8154. DO YOU HAVE EXHIBIT 8154 BEFORE YOU?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND IS THIS AN EMAIL CHAIN BETWEEN PEOPLE AT THE THERANOS COMPANY?
AUDRA ZACHMAN: IT APPEARS TO BE, YES.
MR. BOSTIC: AND YOU DIDN'T HAVE ACCESS TO THIS EMAIL DURING THE RELEVANT TIME PERIOD, DID YOU?
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES EXHIBIT 8154 INTO EVIDENCE. I BELIEVE PREVIOUS WITNESSES HAVE LAID THE FOUNDATION FOR THIS.
MS. TREFZ: OBJECTION. HEARSAY. PREVIOUS WITNESSES HAVE NOT LAID THE FOUNDATION. THIS WITNESS CANNOT LAY THE FOUNDATION, AND WE HAVE NOT HEARD ANY TESTIMONY BY BASICALLY ANY OF THE WITNESSES ON THIS EMAIL.
MR. BOSTIC: YOUR HONOR, TO CLARIFY. THE FOUNDATION IS NOT SPECIFIC AS TO THIS DOCUMENT, BUT THE GOVERNMENT IS MOVING THIS IN UNDER 803 AS A BUSINESS RECORD CONSISTENT WITH ERIKA CHEUNG'S TESTIMONY ABOUT EMAIL PRACTICES AMONG LAB PERSONNEL AT THERANOS.
JUDGE DAVILA: I THINK THERE STILL HAS TO BE SOME FOUNDATION LAID FOR THIS, THOUGH. I UNDERSTAND SHE LAID A FOUNDATION FOR -- UNDER 803(6), BUT I THINK THERE NEEDS TO BE AN AUTHENTICATING WITNESS TO TESTIFY ABOUT THIS.
MR. BOSTIC: APOLOGIES, YOUR HONOR. ACTUALLY THE PARTIES STIPULATED TO THE AUTHENTICITY OF EMAILS BEARING THIS BATES PREFIX, SO I DON'T BELIEVE THE DEFENSE'S OBJECTION IS NOT ONE OF AUTHENTICITY.
MS. TREFZ: IT'S NOT AUTHENTICITY. IT'S A HEARSAY ISSUE. I DON'T THINK THE GOVERNMENT HAS LAID A FOUNDATION UNDER 803(6) FOR THIS.
JUDGE DAVILA: WELL, THAT'S WHAT I WAS REFERRING TO. I THINK YOU NEED TO HAVE A FOUNDATIONAL WITNESS TALK ABOUT THIS CHAIN PURSUANT TO 803(6).
MR. BOSTIC: I CAN MOVE ON FOR NOW, YOUR HONOR. THANK YOU.
JUDGE DAVILA: ALL RIGHT.
BY MR. BOSTIC:
MR. BOSTIC: DR. ZACHMAN, LET'S LOOK AT EXHIBIT 2083, PLEASE.
AUDRA ZACHMAN: OKAY.
MR. BOSTIC: AND DO YOU RECOGNIZE THE DOCUMENT MARKED AS EXHIBIT 2083?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND WHAT IS THAT DOCUMENT?
AUDRA ZACHMAN: IT'S AN EMAIL FROM MYSELF TO A REPRESENTATIVE OF THERANOS TO CHECK BACK IN WITH ME TO SEE IF I WAS ABLE TO HAVE A CONVERSATION REGARDING THE HCG RESULTS.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES EXHIBIT 2083 INTO EVIDENCE.
MS. TREFZ: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 2083 WAS RECEIVED IN EVIDENCE.)
BY MR. BOSTIC:
MR. BOSTIC: DR. ZACHMAN, DO YOU SEE AN EMAIL FROM SOMEONE NAMED LESLIE NEVILLE AT THERANOS TO YOU?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND WHAT IS THE DATE OF THIS EMAIL?
AUDRA ZACHMAN: OCTOBER 14TH.
MR. BOSTIC: SO APPROXIMATELY A WEEK AFTER THE RESULTS THAT WE WERE LOOKING AT?
AUDRA ZACHMAN: THAT SOUNDS RIGHT.
MR. BOSTIC: CAN YOU WALK US THROUGH AGAIN WHAT IS HAPPENING IN YOUR STREAM OF COMMUNICATIONS WITH THERANOS?
AUDRA ZACHMAN: SURE. SO LESLIE IS CHECKING BACK IN WITH ME TO SEE IF I WAS ABLE TO SPEAK TO SOMEONE NAMED CHRISTIAN HOLMES REGARDING THE HCG QUANTS THAT I HAD CONCERNS WITH.
MR. BOSTIC: DO YOU RECALL HAVING A TELEPHONE CONVERSATION WITH SOMEONE AT THERANOS AROUND THIS TIME?
AUDRA ZACHMAN: I DO, BUT I'M NOT SURE IT WAS SOMEONE NAMED CHRISTIAN HOLMES.
MR. BOSTIC: OKAY. IF I COULD ASK YOU TO TURN IN YOUR BINDER TO EXHIBIT 5412, PLEASE. LET ME KNOW WHEN YOU HAVE THAT IN FRONT OF YOU.
AUDRA ZACHMAN: WELL, I HAVE THE TABLET BUT NOTHING BEHIND IT.
MR. BOSTIC: ARE YOU MISSING 5412?
AUDRA ZACHMAN: WELL, I HAVE JUST THE TAB FOR IT.
MR. BOSTIC: MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
MR. BOSTIC: (HANDING.)
AUDRA ZACHMAN: THANK YOU.
BY MR. BOSTIC:
MR. BOSTIC: YOU NOW HAVE EXHIBIT 5412 IN FRONT OF YOU?
AUDRA ZACHMAN: I DO. THANK YOU.
MR. BOSTIC: AND WHAT IS EXHIBIT 5412, IF YOU RECOGNIZE IT?
AUDRA ZACHMAN: SO IT'S AN EMAIL FROM SOMEONE NAMED CHRISTIAN TO MYSELF.
MR. BOSTIC: OKAY. AND DID YOU RECEIVE THIS EMAIL ON THE DATE INDICATED?
AUDRA ZACHMAN: I DID.
MR. BOSTIC: AND WHAT IS THE TOPIC OF THE EMAIL GENERALLY SPEAKING?
AUDRA ZACHMAN: ABOUT THE HCG'S THAT I HAD CONCERNS FOR AND AN EXPLANATION FOR THOSE VALUES.
MR. BOSTIC: AND THE PERSON NAMED CHRISTIAN WHO SENT THE EMAIL, WHERE DID THEY WORK AT THE TIME IF YOU CAN TELL FROM THE EMAIL?
AUDRA ZACHMAN: AT THERANOS IN CLIENT SOLUTIONS.
MR. BOSTIC: YOUR HONOR, THE GOVERNMENT MOVES INTO EVIDENCE EXHIBIT 5412.
MS. TREFZ: NO OBJECTION.
JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 5412 WAS RECEIVED IN EVIDENCE.)
MR. BOSTIC: MS. HOLLIMAN, IF WE CAN ZOOM IN ON KIND OF THE MIDDLE THIRD OF THE PAGE TO INCLUDE THAT WHOLE EMAIL MESSAGE. THANK YOU.
MR. BOSTIC: DR. ZACHMAN, ARE YOU SEEING THAT EMAIL THAT YOU RECEIVED IN FRONT OF YOU?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: THE EMAIL MENTIONS THE POSSIBILITY OF A PHONE CALL IN THE COMING DAYS. DO YOU REMEMBER WHETHER YOU HAD MULTIPLE CONVERSATIONS WITH INDIVIDUALS AT THERANOS DURING THIS TIME PERIOD?
AUDRA ZACHMAN: I DON'T, I DON'T REMEMBER HOW MANY CONVERSATIONS WERE HAD. I DO REMEMBER I'M TRYING TO SET UP A PHONE CONVERSATION AND COMPETING ONE WITH A MAN, BUT I'M NOT SURE WHO.
MR. BOSTIC: THERE'S -- IN THAT SECOND PARAGRAPH THERE IS SOME INFORMATION PROVIDED BY THERANOS ABOUT WHAT HAPPENED WITH MS. GOULD'S TEST RESULTS; IS THAT CORRECT?
AUDRA ZACHMAN: THAT'S CORRECT.
MR. BOSTIC: AND CAN YOU SUMMARIZE WHAT INFORMATION YOU RECEIVED FROM THERANOS IN THIS EMAIL?
AUDRA ZACHMAN: UH-HUH. IT'S MY UNDERSTANDING THAT THE EXPLANATION IS THAT IT WAS -- THE LAB WAS PROCESSED CORRECTLY BUT ENTERED INCORRECTLY BY HUMAN ERROR AND THAT IT WAS ENTERED AS 1/100TH OF THE TRUE VALUE.
MR. BOSTIC: AND IS THIS -- DID YOU UNDERSTAND THIS TO BE A REFERENCE TO THE REASON FOR THE CORRECTED VALUE THAT YOU LATER RECEIVED FOR THAT HCG TEST?
AUDRA ZACHMAN: YES.
MR. BOSTIC: I BELIEVE YOU SAID THAT EVEN WITH THAT CORRECTED VALUE, THOSE RESULTS WOULD STILL BE QUESTIONABLE TO YOU; IS THAT CORRECT?
AUDRA ZACHMAN: THAT'S CORRECT.
MR. BOSTIC: AND AFTER RECEIVING THIS EMAIL, DID YOUR VIEWS CHANGE? WAS THIS A MORE SATISFYING EXPLANATION TO YOU?
AUDRA ZACHMAN: IT WAS NOT.
MR. BOSTIC: WHY NOT?
AUDRA ZACHMAN: WELL, BECAUSE EVEN IF THAT'S THE CONCERN OR HOW THE VALUES CAME TO BE, THEY STILL DON'T FIT THE CLINICAL PICTURE. SO IT BROUGHT A LITTLE BIT MORE INTO QUESTION FOR ME.
MR. BOSTIC: OKAY. IN ANY OF YOUR FOLLOW-UP COMMUNICATIONS WITH THERANOS, DID YOU RECEIVE WHAT YOU VIEWED AS A SATISFACTORY EXPLANATION THAT RESTORED YOUR FAITH IN THE COMPANY?
MR. BOSTIC: DID THERE COME A TIME WHEN YOU STOPPED REFERRING YOUR PATIENTS FOR HCG TESTING AT THERANOS?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND WAS THAT PRIMARILY BECAUSE OF YOUR EXPERIENCE WITH MS. GOULD'S TEST RESULTS?
AUDRA ZACHMAN: YES.
MR. BOSTIC: ONE MOMENT, YOUR HONOR.
(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)
MR. BOSTIC: NO FURTHER QUESTIONS. THANK YOU, DR. ZACHMAN.
AUDRA ZACHMAN: THANK YOU.
JUDGE DAVILA: CROSS-EXAMINATION?
MS. TREFZ: ONE MORE SECOND.
JUDGE DAVILA: LADIES AND GENTLEMEN OF THE JURY, IT'S ABOUT FIVE MINUTES TO 2:00. WE MAY -- IS THERE ANY OBJECTION TO GOING OVER A LITTLE BIT? DOES ANYONE HAVE -- WILL THAT CREATE A PROBLEM FOR ANYONE HERE? THANK YOU SO MUCH. I APPRECIATE YOUR GENEROSITY. THANK YOU.
MS. TREFZ: MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
MS. TREFZ: (HANDING.)
AUDRA ZACHMAN: THANK YOU.
MS. TREFZ: UH-HUH.
CROSS-EXAMINATION BY MS. TREFZ:
MS. TREFZ: GOOD AFTERNOON, DR. ZACHMAN. MY NAME IS KATIE TREFZ. I REPRESENT MS. HOLMES. I JUST HAVE A FEW QUESTIONS FOR YOU TODAY.
AUDRA ZACHMAN: OKAY.
MS. TREFZ: TO START, I WANT TO TALK A LITTLE BIT MORE ABOUT HCG -- GIVE ME A SECOND. I'M A LITTLE SHORTER THAN MR. BOSTIC. I WANT TO TALK A LITTLE BIT MORE ABOUT HCG. HCG IS SOMETHING THAT YOU USE IN YOUR JOB ON A DAILY BASIS?
AUDRA ZACHMAN: IF I SEE AN OBSTETRICAL PATIENT THAT DAY, YES.
MS. TREFZ: OKAY. AND DOES YOUR KNOWLEDGE ABOUT HCG INCLUDE UNDERSTANDING GENERALLY THE STATE OF THE SCIENCE AND IN TERMS OF HOW IT'S MEASURED?
AUDRA ZACHMAN: I WOULD SAY THAT I INTERPRET VALUES MORE THAN THE SCIENCE BEHIND IT.
MS. TREFZ: OKAY. DO YOU UNDERSTAND THAT THERE ARE TWO COMMON TYPES OF HCG TESTS, QUALITATIVE AND QUANTITATIVE?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND CAN YOU DESCRIBE FOR US WHAT A QUALITATIVE HCG TEST IS?
AUDRA ZACHMAN: SURE. A QUALITATIVE IS A YES OR NO OR POSITIVE OR NEGATIVE WHERE A QUANTITATIVE GIVES A VALUE ASSOCIATED TO THAT.
MS. TREFZ: OKAY. AND AN EXAMPLE OF A QUALITATIVE HCG TEST IS LIKE A HOME PREGNANCY TEST?
AUDRA ZACHMAN: RIGHT.
MS. TREFZ: AND THE QUANTITATIVE TEST, WE HAVE SEEN SOME NUMBERS. AND CAN YOU DESCRIBE FOR US WHAT THE UNIT IS THAT WE'RE MEASURING WHEN WE ARE LOOKING AT THEM?
AUDRA ZACHMAN: I BELIEVE THAT IT IS MILLI, INTERNATIONAL UNITS PER MILLILITER.
MS. TREFZ: OKAY. AND YOU AS THE MEDICAL PROFESSIONAL, YOU USE THESE RESULTS ALONG WITH AN EXAMINATION AND OTHER FACTORS TO DETERMINE PREGNANCY?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND DO THOSE OTHER FACTORS INCLUDE THE DAY OF THE LAST MENSTRUAL PERIOD?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND THEY CAN INCLUDE WHAT YOU MIGHT SEE ON AN ULTRASOUND?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND AT WHAT, AT WHAT HCG LEVEL CAN A GESTATIONAL SAC GENERALLY BE DETECTED BY ULTRASOUND IF YOU KNOW?
AUDRA ZACHMAN: USUALLY BY ABOUT 1500.
MS. TREFZ: OKAY. AND AT WHAT HCG LEVEL CAN A PRACTITIONER TYPICALLY IDENTIFY A VISIBLE EMBRYO POTENTIALLY WITH A HEARTBEAT THROUGH A TRANSVAGINAL ULTRASOUND?
AUDRA ZACHMAN: I'M NOT SURE, BUT I WOULD GUESS AROUND 300 -- OR 3,000.
MS. TREFZ: OKAY. AND DOES SOUTHWEST CONTEMPORARY WOMEN'S CARE HAVE ULTRASOUND EQUIPMENT IN THE OFFICE?
AUDRA ZACHMAN: WE DO.
MS. TREFZ: AND AS A NURSE PRACTITIONER ARE YOU ABLE TO USE IT IF YOU NEEDED TO?
AUDRA ZACHMAN: IF I NEEDED TO IN A BIND, BUT THAT'S NOT MY TYPICAL PRACTICE, NO.
MS. TREFZ: WHO TYPICALLY PERFORMS SUCH ULTRASOUNDS?
AUDRA ZACHMAN: WE HAVE ULTRASONOGRAPHERS THAT DO.
MS. TREFZ: AND GOING BACK TO THE HCG MEASUREMENT, BOTH THE QUANTITATIVE TESTS AND THE QUALITATIVE TESTS, DO YOU UNDERSTAND THAT THEY'RE MEASURED THROUGH A METHOD CALLED AN IMMUNOASSAY?
AUDRA ZACHMAN: I BELIEVE SO, ALTHOUGH I'M NOT SURE.
MS. TREFZ: OKAY. ARE YOU AWARE THAT THERE ARE MORE THAN 100 DIFFERENT HCG IMMUNOASSAYS COMMERCIALLY AVAILABLE?
AUDRA ZACHMAN: I AM NOT AWARE OF THAT.
MS. TREFZ: OKAY. DO YOU KNOW HOW AN IMMUNOASSAY WORKS?
MS. TREFZ: ARE YOU AWARE THAT DIFFERENCES IN THE RESULT CAN -- OR DIFFERENCES IN THE IMMUNOASSAY CAN RESULT IN VARIABILITY AND REPORTED VALUES AMONG DIFFERENT PROVIDERS? FOR EXAMPLE, IF QUEST USES A PARTICULAR METHOD WITH A PARTICULAR ANTIBODY AND THERANOS USES A DIFFERENT METHOD WITH A DIFFERENT ANTIBODY, ARE YOU AWARE THAT THEY CAN PRODUCE DIFFERENT RESULTS AND THAT'S EXPECTED?
AUDRA ZACHMAN: I AM NOT AWARE OF THAT.
MS. TREFZ: OKAY. CAN WE TAKE A LOOK AT 3305 AGAIN, WHICH IS IN EVIDENCE. MR. BENNETT, IF YOU CAN HIGHLIGHT -- YEAH, EXACTLY. DR. ZACHMAN, CAN YOU TAKE A LOOK AT THE PART OF THIS RESULT THAT SAYS -- THAT IS THE PARAGRAPH BEGINNING WITH "THIS HCG ELECTRO CHEMILUMINESCENT IMMUNOASSAY."
AUDRA ZACHMAN: DO YOU WANT ME TO READ THE REST OF IT?
MS. TREFZ: IF YOU CAN, YES. THANK YOU.
AUDRA ZACHMAN: WAS PERFORMED USING MAYBE ROCHE OR ROCHE ALEXIS REAGENTS. THIS ASSAY IS A TOTAL BETA SUB UNIT ASSAY. IT MEASURES INTACT -- MAYBE IT SAYS NICKED. THE "I" IS A LITTLE HARD TO SEE THERE. FREE BETA AND NICKED -- IT IS NICKED -- FREE BETA HCG. REBASE LINING MAY BE NECESSARY WHEN USING ANOTHER ASSAY.
MS. TREFZ: IS THAT -- DO YOU HAVE AN UNDERSTANDING OF WHAT REBASE LINING MAY BE NECESSARY WHEN USING ANOTHER ASSAY MEANS?
AUDRA ZACHMAN: I DO NOT.
MS. TREFZ: IS THIS TYPICALLY APART OF THE HCG TEST RESULT THAT YOU USE, THIS PARAGRAPH?
AUDRA ZACHMAN: I DO NOT USUALLY EVALUATE THAT PARAGRAPH, NO.
MS. TREFZ: OKAY. YOU TESTIFIED ABOUT BEING CONCERNED WHEN A PATIENT'S HCG DOES NOT DOUBLE EVERY TWO TO THREE DAYS ROUGHLY.
AUDRA ZACHMAN: ROUGHLY.
MS. TREFZ: YEAH. AND IF IT DOESN'T DO THAT, WHAT IS YOUR FIRST STEP?
AUDRA ZACHMAN: IT DEPENDS ON HOW FAR ALONG IN THE PREGNANCY THEY ARE. CERTAINLY IF THEY'RE FAR ENOUGH ALONG TO BE ABLE TO SEE SOMETHING ON ULTRASOUND, THEN WE CAN GET THEM IN FOR ULTRASOUND. IF THEY'RE EARLIER IN THE PREGNANCY THEN IT'S TO HAVE COMMUNICATION ABOUT WHAT THEIR PHYSICAL EXPERIENCE IS AND FOLLOW THE TREND FROM THERE.
MS. TREFZ: AND FOLLOWING THE TREND MEANS INCLUDING RETESTING?
AUDRA ZACHMAN: RIGHT.
MS. TREFZ: AND DID THE NEED TO REPEAT A DRAW BECAUSE VALUES DIDN'T DOUBLE, THAT'S NOT SOMETHING THAT IS UNIQUE TO THERANOS; CORRECT? THAT HAPPENS?
AUDRA ZACHMAN: THAT HAPPENS.
MS. TREFZ: OKAY. WHEN YOU WERE SPEAKING WITH MR. BOSTIC ABOUT THE DROP IN NUMBERS FOR MS. GOULD'S RESULTS, WERE YOU COMPARING THE 12,558 TO THE THERANOS TEST RESULT OR THE SONORA QUEST RESULT, THE PRIOR --
AUDRA ZACHMAN: IT WAS --
MS. TREFZ: SORRY. GO AHEAD.
AUDRA ZACHMAN: IT WAS MORE THE DROP FROM THE 12,000 TO THE 125, SO BOTH THERANOS DRAWS.
MS. TREFZ: OKAY. AT A RESULT OF 12,558, WOULD YOU HAVE EXPECTED TO SEE THE PREGNANCY ON AN ULTRASOUND?
AUDRA ZACHMAN: AT THAT VALUE, YES, BUT NOT BASED OFF OF HER LAST PERIOD.
MS. TREFZ: OKAY. WHEN YOU SPOKE WITH MS. GOULD ABOUT THE RESULT, DID SHE COME INTO YOUR OFFICE FOR AN APPOINTMENT?
AUDRA ZACHMAN: WE DID HAVE AN APPOINTMENT. I ALSO REACHED OUT TO HER VIA PHONE ONE OF THE DAYS AS I REMEMBER.
MS. TREFZ: AND WAS THE FIRST -- I BELIEVE YOU TESTIFIED THAT YOU LET HER KNOW THAT HER NUMBERS WERE DROPPING. WAS THAT THE FIRST THING THAT YOU LET HER KNOW?
AUDRA ZACHMAN: I CAN'T REMEMBER.
MS. TREFZ: OKAY. IN YOUR PHONE CALL WITH HER, IF IT WAS THE FIRST -- IF THAT HAPPENED FIRST OR YOUR FIRST MEETING WITH HER, DO YOU REMEMBER ASKING WHETHER SHE WAS REPORTING VAGINAL BLEEDING?
AUDRA ZACHMAN: I REMEMBER ASKING HER, YEAH.
MS. TREFZ: AND WHAT WAS HER RESPONSE?
AUDRA ZACHMAN: NO, SHE WAS NOT BLEEDING.
MS. TREFZ: AND GIVEN THE DROP IN THE NUMBERS FROM 12,558 TO 125.58 WAS IT SURPRISING TO YOU THAT SHE WASN'T BLEEDING?
AUDRA ZACHMAN: YES.
MS. TREFZ: DID YOU -- SO AS PART OF YOUR PLAN FORWARD, DID YOU ADVISE MS. GOULD TO REPEAT THE LAB?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND DID YOU ADVISE HER TO KEEP HER FOLLOW-UP APPOINTMENT?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND DID YOU ADVISE HER TO CONTINUE WITH HER PRENATAL VITAMINS AND HER PROGESTERONE?
AUDRA ZACHMAN: YES.
MS. TREFZ: YOU TESTIFIED ABOUT REACHING OUT TO THERANOS. YOU REACHED OUT TO THERANOS TO INFORM THERANOS ABOUT YOUR CONCERNS; CORRECT? YOU'VE TESTIFIED ABOUT THAT?
AUDRA ZACHMAN: CORRECT.
MS. TREFZ: AND WHEN YOU RAISED THE CONCERNS, YOU IDENTIFIED TWO PATIENTS, MS. GOULD AND ANOTHER PATIENT. DO YOU RECALL THAT?
AUDRA ZACHMAN: I DON'T.
MS. TREFZ: IF WE CAN TAKE A LOOK BACK AT EXHIBIT 5412, WHICH IS IN EVIDENCE. I'M JUST GOING TO SEE IF I CAN REFRESH YOU. SO JUST FOCUSSING ON THE FIRST PARAGRAPH, WE HAVE INVESTIGATED THE MATTER THAT YOU BROUGHT TO OUR ATTENTION RECENTLY AND HAVE DISCOVERED THAT IN THREE OUT OF THE FOUR CASES. DOES THAT REFRESH YOUR RECOLLECTION AT ALL THAT THERE WAS ANOTHER PATIENT THAT YOU IDENTIFIED?
AUDRA ZACHMAN: I DON'T REMEMBER ANOTHER PATIENT, NO.
MS. TREFZ: OKAY. WE MAY COME BACK TO THAT. IN MR. HOLMES EMAIL -- IF WE CAN KEEP THAT UP. SORRY, MR. BENNETT. MR. HOLMES EXPRESSED THE COMPANY'S SINCERE AND DEEP APOLOGY FOR THE ERROR?
AUDRA ZACHMAN: YES, I SAW THAT THERE. YES.
MS. TREFZ: SORRY. WE NEED AN AUDIBLE ANSWER FOR THE COURT REPORTER.
AUDRA ZACHMAN: OH, I'M SORRY. YES.
MS. TREFZ: AND MR. HOLMES ALSO SAID THAT CORRECTIVE ACTION HAD BEEN TAKEN BOTH WITH RESPECT TO PROCEDURES AND WITH RESPECT TO THIS SPECIFIC ERROR?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND HE OFFERED TO DO WHATEVER IS NECESSARY TO ENSURE YOUR CONFIDENCE AND COMFORT WITH THE PLATFORM?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND HE GAVE YOU HIS PERSONAL EMAIL AND HIS CELL PHONE NUMBER?
AUDRA ZACHMAN: YES.
MS. TREFZ: DO YOU RECALL ASKING MR. HOLMES TO PROVIDE THE CORRECTED VALUES OR THE CORRECTED LAB REPORTS BY EMAIL AND FAX?
AUDRA ZACHMAN: I THINK THEY WERE OFFERED AND I AGREED.
MS. TREFZ: OKAY. DO YOU RECALL THAT -- ACTUALLY GOING BACK TO THE QUESTION THAT I ASKED YOU A MINUTE OR TWO AGO. YOU IDENTIFIED THAT YOU DIDN'T REMEMBER WHETHER THERE WAS ANOTHER PATIENT. LET ME SEE IF I CAN REFRESH YOU ON THAT. IF I CAN HAVE YOU TURN TO EXHIBIT 11430 WHICH SHOULD BE IN YOUR BINDER. IF IT IS NOT, LET ME KNOW.
AUDRA ZACHMAN: I HAVE 1143.
MS. TREFZ: DO YOU HAVE 11430?
AUDRA ZACHMAN: 430, YEP.
MS. TREFZ: AND THERE'S NO NEED TO DESCRIBE IT OR READ IT OR READ IT OUT LOUD, BUT IF YOU CAN JUST TAKE A READ OF THIS DOCUMENT AND SEE IF IT REFRESHES YOUR RECOLLECTION ABOUT THAT ADDITIONAL PATIENT.
AUDRA ZACHMAN: OKAY.
(PAUSE IN PROCEEDINGS.)
AUDRA ZACHMAN: OKAY.
BY MS. TREFZ:
MS. TREFZ: DOES THIS DOCUMENT REFRESH YOUR RECOLLECTION ABOUT AN ADDITIONAL PATIENT WHOSE TEST RESULTS YOU RAISED WITH THERANOS?
AUDRA ZACHMAN: NO, I DON'T REMEMBER THIS CIRCUMSTANCE.
MS. TREFZ: OKAY. WE WILL MOVE ON. IN ADDITION -- WE SAW, AND I THINK YOU TESTIFIED ABOUT THERANOS'S OFFER FOR A PHONE CALL. THERANOS OFFERED OTHER AVENUES TO ADDRESS SOUTHWEST CONTEMPORARY WOMEN'S CARE REMAINING CONCERNS; IS THAT CORRECT?
AUDRA ZACHMAN: THAT'S CORRECT.
MS. TREFZ: AND THEY OFFERED TO DO A STUDY?
AUDRA ZACHMAN: CORRECT.
MS. TREFZ: AND THEY ALSO OFFERED TO PUT SOUTHWEST CONTEMPORARY WOMEN'S CARE PROVIDERS IN TOUCH WITH MS. HOLMES; IS THAT CORRECT?
AUDRA ZACHMAN: I DON'T REMEMBER.
MS. TREFZ: AND DO YOU REMEMBER WHETHER THAT WAS -- LET ME SEE IF I CAN REFRESH YOUR RECOLLECTION ON THAT FIRST.
AUDRA ZACHMAN: OKAY.
MS. TREFZ: PLEASE TURN TO 7549. AGAIN, WE'RE USING THIS DOCUMENT TO SEE IF YOUR RECOLLECTION IS REFRESHED, SO THERE'S NO NEED TO READ IT TO THE GROUP.
AUDRA ZACHMAN: SURE.
MS. TREFZ: BUT IF YOU CAN JUST TAKE A READ OF IT YOURSELF.
AUDRA ZACHMAN: SURE. OKAY.
MS. TREFZ: DOES THIS DOCUMENT REFRESH YOUR RECOLLECTION THAT THERANOS OFFERED TO PUT YOUR OFFICE IN TOUCH WITH MS. HOLMES DIRECTLY?
AUDRA ZACHMAN: I SEE IT'S WRITTEN HERE, YES.
MS. TREFZ: AND DO YOU RECALL THIS BEING SOMETHING THAT YOU DECLINED?
AUDRA ZACHMAN: I KNOW THAT WE HAD A CONVERSATION. IT MENTIONS ANOTHER PHYSICIAN THERE, DR. GRAYSON, AND I SPOKE ON THE PHONE WITH A MAN, AGAIN, I DON'T REMEMBER WHO IT WAS, PERHAPS AFTER THIS, AND IT SEEMS IT'S IN REFERENCE TO THIS SITUATION.
MS. TREFZ: OKAY. YOU DON'T REMEMBER SPECIFICALLY WHETHER YOU DECLINED TO SPEAK WITH MS. HOLMES OR NOT?
AUDRA ZACHMAN: I KNOW THAT I DID NOT SPEAK TO MS. HOLMES.
MS. TREFZ: WE MENTIONED A MINUTE AGO THE STUDY THAT THERANOS VOLUNTEERED FOR AND THAT WAS SOMETHING THAT DID END UP HAPPENING; CORRECT?
AUDRA ZACHMAN: YES.
MS. TREFZ: SOUTHWEST CONTEMPORARY WOMEN'S CARE HELPED DEVELOP THE STUDY; CORRECT?
AUDRA ZACHMAN: CORRECT.
MS. TREFZ: AND IT WAS IN AUGUST OF 2015?
AUDRA ZACHMAN: CORRECT. YES, THAT'S WHAT I REMEMBER, THAT'S CORRECT.
MS. TREFZ: AND IT HAD BEEN DISCUSSED AS EARLY AS MAY OR BEFORE THEN; CORRECT?
AUDRA ZACHMAN: UH-HUH. THINGS MOVE SLOWLY.
MS. TREFZ: FAIR. DO YOU, DO YOU RECALL PARTICIPATING IN THE DESIGN OF THE STUDY?
AUDRA ZACHMAN: BRIEFLY. IT WAS PART OF THE PRODUCT COMMITTEE'S ENDEAVOR TO DO, AND I HAD HANDED OVER -- IN THE LONG WINDED KIND OF CONVERSATION TO GET THAT GOING, I HAD HANDED OVER THE TITLE FOR KIND OF LEADING THE PRODUCT COMMITTEE AND THE TRIAL.
MS. TREFZ: OKAY. DO YOU RECALL THAT THE STUDY WOULD COMPARE SERUM QUANTS THROUGH SONORA QUEST TO FINGERSTICK QUANTS RUN THROUGH THERANOS AND SERUM QUANTS SENT TO AN INDEPENDENT THIRD PARTY LAB?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND JUST TO PUT THAT IN I GUESS PLAINER ENGLISH, ESSENTIALLY DOES THAT MEAN THAT THE IDEA WAS TO COMPARE THERANOS FINGERSTICK TESTS TO SONORA QUEST VENOUS DRAWS TO A THIRD PARTY'S VENOUS DRAWS?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND YOU HAD FAMILIARITY WITH SONORA QUEST; CORRECT?
AUDRA ZACHMAN: CORRECT.
MS. TREFZ: AND WERE YOU ALSO FAMILIAR WITH THE NATIONAL INDEPENDENT LABORATORY THAT THEY USED?
AUDRA ZACHMAN: I WAS NOT, HUH-UH.
MS. TREFZ: AND DO YOU RECALL THAT THAT THIRD LABORATORY WAS ARUP, A-R-U-P?
AUDRA ZACHMAN: IN RECENTLY REFERENCING THOSE EMAILS I'M REMINDED OF THAT, BUT AT THE TIME, NO.
MS. TREFZ: OKAY. DO YOU RECALL RECEIVING THE RESULTS OF THE STUDY?
AUDRA ZACHMAN: UM, KIND OF THE SUMMARIZED RESULTS. IS THAT WHAT YOU MEAN?
MS. TREFZ: YES.
AUDRA ZACHMAN: I REMEMBER THAT THEY WERE SUMMARIZED AND KIND OF A PRESENTATION WAS GIVEN ON THEM BY THE LEAD OF THE PRODUCT COMMITTEE AT THE TIME AT ONE OF OUR PROVIDER MEETINGS.
MS. TREFZ: OKAY. AND AFTER THE STUDY SOUTHWEST CONTEMPORARY WOMEN'S STUDY STARTED USING THERANOS AGAIN; CORRECT?
AUDRA ZACHMAN: I DID NOT OR CERTAINLY I DIDN'T PUT ACKNOWLEDGEMENT OUT FOR PATIENTS ENCOURAGING THEM TO GO THERE TO THERANOS. I DON'T REMEMBER MY PEERS FEELING OR VOICING THAT THEY WANTED TO USE THERANOS MORE, BUT AS I REMEMBER IT, PATIENTS DIDN'T NEED AN ORDER TO GET THEIR LABS DRAWN. SO WE CONTINUED TO HAVE PATIENTS COME IN WITH LAB RESULTS FROM THERANOS.
MS. TREFZ: IN FACT, IT WAS A LOT OF PATIENTS; CORRECT?
AUDRA ZACHMAN: I DIDN'T EVER COUNT.
MS. TREFZ: FROM -- ARE YOU AWARE THAT FROM OCTOBER 2015 THROUGH OCTOBER 2016 THERANOS PERFORMED OVER 300 HCG TESTS FOR SOUTHWEST CONTEMPORARY WOMEN'S CARE?
AUDRA ZACHMAN: NO, I AM NOT.
MS. TREFZ: AND DID THAT INCLUDE SEVERAL PATIENTS OF YOURS WHO HAD THERANOS TESTS BETWEEN OCTOBER 2015 AND OCTOBER 2016?
AUDRA ZACHMAN: I DON'T REMEMBER THOSE CIRCUMSTANCES.
MS. TREFZ: OKAY. LET ME SEE IF I CAN JUST REFRESH YOUR RECOLLECTION ON THOSE PARTICULAR PATIENTS.
MS. TREFZ: MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
MS. TREFZ: (HANDING.) I'M NOT SURE THIS IS IN YOUR BINDER.
MS. TREFZ: DR. ZACHMAN, I'VE HANDED YOU FOR IDENTIFICATION PURPOSES 13786 THROUGH 13790.
AUDRA ZACHMAN: OKAY.
MS. TREFZ: AND CAN YOU JUST TAKE A LOOK AT THOSE DOCUMENTS AND SEE IF THEY REFRESH YOUR RECOLLECTION ABOUT PATIENTS OF YOURS WHO RECEIVED THERANOS TESTS AFTER OCTOBER OF 2015?
AUDRA ZACHMAN: I AM ALTHOUGH NOT REMEMBERING WHEN THESE VALUES WERE BROUGHT TO ME OF COURSE AT THE TIME, I DO SEE, YES, THEY ARE PATIENTS OF MINE DRAWN AT THERANOS FOR HCG QUANTS.
MS. TREFZ: ARE YOU AWARE THAT -- STRIKE THAT. LET ME BACK UP FOR A SECOND. YOU MENTIONED THAT YOU HANDED THE PRODUCT COMMITTEE OFF TO SOMEONE ELSE WITHIN SOUTHWEST CONTEMPORARY WOMEN'S CARE. WHO WAS THAT?
AUDRA ZACHMAN: COURTNEY DOMINGO. SHE'S ANOTHER NURSE PRACTITIONER.
MS. TREFZ: AND DO YOU RECALL THAT DR. DOMINGO WAS WORKING WITH THERANOS TO FINALIZE THAT STUDY AND PREPARE THE RESULTS?
AUDRA ZACHMAN: IT'S MY UNDERSTANDING THAT SHE WOULD HAVE BEEN, ALTHOUGH I DON'T KNOW THAT I WAS PART OF THAT COMMUNICATION.
MS. TREFZ: OKAY. DO YOU RECALL THAT DR. DOMINGO INFORMED THERANOS ON SEPTEMBER 13TH OF 2015 THAT THERANOS -- THAT THE TRENDS BETWEEN ALL THREE LABS LOOKED GOOD AND FOLLOWED THE SAME LINES?
AUDRA ZACHMAN: UNLESS I WAS PART OF THAT COMMUNICATION, I WOULDN'T BE AWARE OF IT.
MS. TREFZ: OKAY. ARE YOU AWARE THAT FROM SEPTEMBER 18TH, 2014, TO OCTOBER 10TH, 2016, SOUTHWEST CONTEMPORARY WOMEN'S CARE RECEIVED RESULTS FROM NEARLY 20,000 THERANOS ORDERS?
AUDRA ZACHMAN: I'M NOT AWARE OF THAT.
MS. TREFZ: AT THE GOVERNMENT'S REQUEST YOU DID A THOROUGH REVIEW TO IDENTIFY THE THERANOS RESULTS THAT MAY HAVE BEEN INCORRECT AND MAY HAVE MADE A CLINICAL DIFFERENCE; CORRECT?
AUDRA ZACHMAN: COULD YOU REPEAT THAT QUESTION?
MS. TREFZ: YES. AT THE GOVERNMENT'S REQUEST YOU DID A THOROUGH REVIEW TO IDENTIFY THERANOS RESULTS THAT YOU BELIEVED MAY HAVE BEEN INCORRECT AND MAY HAVE MADE A CLINICAL DIFFERENCE; IS THAT CORRECT?
AUDRA ZACHMAN: YES.
MS. TREFZ: AND IS IT THE CASE THAT ON JANUARY 5TH OF THIS YEAR YOU TOLD THE GOVERNMENT THAT YOU HAD REVIEWED ALL OF THE CHARTS AND YOU DID NOT COME UP WITH MUCH THAT SEEMED OUT OF PLACE?
AUDRA ZACHMAN: THAT'S CORRECT.
MS. TREFZ: AND THAT YOU LATER CIRCLED BACK AND INFORMED THEM THAT AFTER A THOROUGH REVIEW IT HAD BEEN DETERMINED THAT THERE WERE NOT ANY QUANT RESULTS THAT IF IN QUESTION NEEDED ANY CLINICAL DIFFERENCE?
AUDRA ZACHMAN: THAT'S CORRECT.
MS. TREFZ: AND IT WAS ONLY MS. GOULD?
AUDRA ZACHMAN: THAT WAS SO OUT OF PLACE. THERE WERE SOME WITHIN THOSE CHARTS THAT YOU, AGAIN, KNOWING THE OUTCOME, CAN LOOK BACK AND SAY, WELL, I WONDER IF IT DID THAT, THE QUANT ITSELF? OR I WONDER IF THAT VALUE SHOULD HAVE BEEN A LITTLE BIT HIGHER OR A LITTLE BIT LOWER? BUT THAT IT DIDN'T INDICATE AT THAT TIME JUST WHAT THE QUANTS, A LOSS OR A SUCCESSFUL PREGNANCY, AND THAT THE OUTCOME WAS DIFFERENT THAN THAT.
MS. TREFZ: OKAY. DO YOU RECALL ENDING THIS EMAIL BY SAYING SORRY THAT YOU DON'T HAVE MORE TO REPORT?
AUDRA ZACHMAN: UH-HUH. I'M SURE I DID.
MS. TREFZ: WHY WERE YOU APOLOGIZING?
AUDRA ZACHMAN: TO BE KIND. RESPECTFUL.
MS. TREFZ: OKAY. YOU UNDERSTOOD THAT THE GOVERNMENT WANTED YOU TO FIND ADDITIONAL ISSUES IN YOUR THERANOS CHARTS?
AUDRA ZACHMAN: NO. I THINK THAT THEY JUST WANTED ME TO TAKE MY TIME TO LOOK THROUGH ANYTHING THAT MIGHT HAVE BEEN OVERLOOKED AT THE TIME.
MS. TREFZ: OKAY. JUST ONE SECOND HERE. GOING BACK TO THE INTRODUCTION OF THERANOS TO YOUR OFFICE --
AUDRA ZACHMAN: UH-HUH.
MS. TREFZ: -- DO YOU RECALL WHO CAME IN TO DO THE TALKS ABOUT THERANOS?
AUDRA ZACHMAN: I DON'T.
MS. TREFZ: AND DO YOU REMEMBER HOW LONG IT LASTED?
AUDRA ZACHMAN: I BELIEVE THAT WE STRUCTURED THE MEETING TO BE KIND OF 15 TO 20 MINUTE TIME SLOTS. IT WAS BRIEF.
MS. TREFZ: OKAY. AND YOU DON'T RECALL ANY DISCUSSIONS WITH THERANOS REGARDING THE REGULATORY STATUS OF ITS TESTS --
AUDRA ZACHMAN: I'M SORRY, I DON'T REMEMBER THAT. I DON'T REMEMBER THAT, NO.
MS. TREFZ: AND YOU UNDERSTAND THAT FDA APPROVALS ARE PUBLIC; RIGHT?
AUDRA ZACHMAN: I UNDERSTAND THAT.
MS. TREFZ: AND YOU UNDERSTAND THAT CURRENT CERTIFICATION STATUS OF LABORATORIES ARE ALSO PUBLICLY AVAILABLE?
AUDRA ZACHMAN: I UNDERSTAND THAT.
MS. TREFZ: OKAY. NO FURTHER QUESTIONS, YOUR HONOR.
JUDGE DAVILA: MR. BOSTIC?
MR. BOSTIC: BRIEFLY, YOUR HONOR.
REDIRECT EXAMINATION BY MR. BOSTIC:
MR. BOSTIC: GOOD AFTERNOON AGAIN, DR. ZACHMAN.
AUDRA ZACHMAN: GOOD AFTERNOON.
MR. BOSTIC: JUST NOW YOU HAD A BRIEF DISCUSSION WITH DEFENSE COUNSEL ABOUT A STUDY THAT WAS CONDUCTED REGARDING THERANOS HCG TEST RESULTS. DO YOU RECALL THAT?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND WHEN THE RESULTS OF THAT STUDY WERE COMPLETE, DID YOU HAVE AN OPPORTUNITY TO REVIEW THOSE RESULTS?
AUDRA ZACHMAN: BRIEFLY.
MR. BOSTIC: IN SUM, DID THOSE RESULTS RESTORE YOUR CONFIDENCE IN THERANOS'S ABILITY TO DELIVER ACCURATE HCG RESULTS?
MR. BOSTIC: AND WHY NOT IF YOU RECALL?
AUDRA ZACHMAN: MY CARE OF BRITTANY, AND THE VALUES THAT I RECEIVED AT THAT TIME WERE VERY IMPACTFUL TO ME AS A PROVIDER AND PERHAPS EMPHASIZING TO HER AS A WOMAN, AND SO THERE WASN'T MUCH THAT COULD HAVE RESTORED MY FAITH AT THAT TIME.
MR. BOSTIC: DO YOU RECALL HOW MANY PEOPLE PARTICIPATED IN THAT STUDY APPROXIMATELY OR HOW MANY SAMPLES WERE INVOLVED?
AUDRA ZACHMAN: I THINK IT WAS 30.
MR. BOSTIC: THERE WAS ALSO SOME TESTIMONY DURING YOUR CONVERSATION WITH MS. TREFZ ABOUT PATIENTS OF YOURS WHO PATRONIZE THERANOS AFTER YOUR EXPERIENCE WITH MS. GOULD. DO YOU REMEMBER THAT?
AUDRA ZACHMAN: YES.
MR. BOSTIC: AND DID YOU SEND ANY OF THOSE PATIENTS TO THERANOS?
AUDRA ZACHMAN: NOT THAT I REMEMBER, NO.
MR. BOSTIC: AND DID THERE COME A POINT WHERE YOU AFFIRMATIVELY STOPPED SENDING PATIENTS TO THERANOS OR REFERRING PATIENTS TO THAT BLOOD TESTING LAB?
AUDRA ZACHMAN: YES.
MR. BOSTIC: DURING THE 2015 TIME PERIOD WHEN THAT STUDY TOOK PLACE AND WHEN SOME ADDITIONAL SOUTHWEST PATIENTS WERE BEING TESTED AT THERANOS, DO YOU HAVE ANY KNOWLEDGE OF THE METHOD THAT THERANOS WAS USING TO RUN ITS HCG PATIENT SAMPLES?
AUDRA ZACHMAN: I DON'T IN SPECIFIC OCCURRENCES, BUT I DO REMEMBER PATIENTS FEELING, VOICING THAT THEY HAD ANTICIPATED HAVING A FINGERSTICK AND LEFT WITH A VENA PUNCTURE AND FEELING AND VOICING THAT THEY FELT UPSET ABOUT THAT.
MR. BOSTIC: DO YOU RECALL THAT SPECIFICALLY DURING THAT 2015 TIME PERIOD?
AUDRA ZACHMAN: I'M NOT SURE WHAT TIME IT WAS.
MR. BOSTIC: IT MIGHT HAVE BEEN?
AUDRA ZACHMAN: IT MIGHT HAVE BEEN.
MR. BOSTIC: SO THAT'S THE DRAW METHOD. HOW ABOUT THE METHOD THAT THERANOS WAS USING INSIDE OF THE LAB TO ANALYZE THOSE SAMPLES? DO YOU HAVE ANY WAY OF KNOWING WHAT DEVICES WERE BEING USED, FOR EXAMPLE, TO UTILIZE HCG SAMPLES IN THERANOS IN 2015?
AUDRA ZACHMAN: I DON'T.
MR. BOSTIC: THERE WAS SOME BRIEF DISCUSSION ALSO WITH DEFENSE COUNSEL ABOUT POSSIBLE VARIABILITY BETWEEN LABS. DO YOU REMEMBER THAT CONVERSATION?
AUDRA ZACHMAN: YES.
MR. BOSTIC: IF WE CAN GO BACK TO THE DEMONSTRATIVE JUST BRIEFLY.
AUDRA ZACHMAN: OKAY.
MR. BOSTIC: ARE YOU SEEING ON YOUR SCREEN THOSE RESULTS FOR BRITTANY GOULD?
AUDRA ZACHMAN: I DO.
MR. BOSTIC: AND LET'S LOOK JUST AT THE THERANOS RESULTS THIS TIME. LET'S IGNORE THE SONORA QUEST RESULTS. FIRST OF ALL, LOOKING AT THOSE TWO RESULTS FROM THERANOS, ONE 12,500 AND THE NEXT 125. WHAT WOULD THOSE RESULTS HAVE SIGNIFIED TO YOU IN THE ABSENCE OF THE SONORA QUEST RESULTS?
AUDRA ZACHMAN: IF THOSE WERE THE ONLY TWO VALUES THAT I HAD ON A PATIENT, THEN I WOULD ASSUME THAT SHE HAS HAD A LOSS OF PREGNANCY.
MR. BOSTIC: AND, IN FACT, IS THAT WHAT YOU SAW WITH MS. GOULD?
MR. BOSTIC: AND WHAT ABOUT USING THE CORRECTED VALUE THAT THERANOS SENT AFTERWARDS. IF YOU SAW TWO RESULTS TWO DAYS APART EXACTLY AT THE SAME LEVEL, AGAIN, IGNORING THE SONORA QUEST RESULT, WHAT WOULD THAT FLAT LINE RESULT INDICATE TO YOU, IF IT WOULD BE ENOUGH DATA TO TELL?
AUDRA ZACHMAN: IT WOULD BE QUESTIONABLE AT BEST. IF I KNEW SHE WAS IN HER FOURTH WEEK OF PREGNANCY, WHICH SHE WAS, AND I SAW TWO FLAT LINED RESULTS, I WOULD BE SUSPICIOUS FOR AN ECTOPIC, ALTHOUGH, AGAIN, THEY WOULDN'T BE AT THAT VALUE.
MR. BOSTIC: AND DID YOU SEE AN ECTOPIC WITH MS. GOULD OR ANY OTHER ISSUE WITH THAT PREGNANCY?
MR. BOSTIC: NO FURTHER QUESTIONS. THANK YOU.
MS. TREFZ: NO QUESTIONS.
JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?
MS. TREFZ: YES.
MR. BOSTIC: YES.
JUDGE DAVILA: THANK YOU. YOU MAY STAND DOWN.
AUDRA ZACHMAN: THANK YOU SO MUCH.
JUDGE DAVILA: WE KEPT THE JURY 30 MINUTES BEHIND WHAT I PROMISED. SO DO YOU HAVE A WITNESS HERE NOW?
MR. BOSTIC: WE DO, YOUR HONOR, HAVE ANOTHER WITNESS. BUT WE ARE ALSO CONSCIOUS OF THE JURY'S TIME, SO WE WILL DEFER TO THE COURT.
JUDGE DAVILA: ALL RIGHT. WILL WE BE ABLE TO START WITH THAT WITNESS TOMORROW MORNING?
MR. BOSTIC: YES, YOUR HONOR.
JUDGE DAVILA: OKAY. SORRY. IS THERE ANY VALUE JUST BRINGING THAT WITNESS IN, INTRODUCING AND PUTTING THEM UNDER OATH AND GETTING SOME PRELIMINARY TESTIMONY?
MR. LEACH: IT'S REALLY UP TO THE COURT AND THE JURY. I THINK THE WITNESS IS BRIEF AND FROM OUT OF TOWN, SO WE CERTAINLY CAN DO IT NOW. WE CAN ALSO DO IT FIRST THING TOMORROW, YOUR HONOR. WE'RE FINE EITHER WAY.
JUDGE DAVILA: WELL, I TOLD OUR JURY AT THE START THAT THEY'RE JUDGES OF THE FACTS. THEY'RE ALSO JUDGES OF THEIR TIME I SUPPOSE. LADIES AND GENTLEMEN, LET ME ASK YOU, IF WE WENT 30 MORE MINUTES UNTIL 3:00 O'CLOCK, AND I PROMISE WE'LL STOP THERE, WILL THAT CREATE ANY DIFFICULTY FOR ANYONE? I SEE NO HANDS. LET'S BRING THE WITNESS IN AND SEE WHAT WE CAN ACCOMPLISH. THANK YOU, LADIES AND GENTLEMEN.
MR. LEACH: THANK YOU, YOUR HONOR. THANK YOU, LADIES AND GENTLEMEN. THE UNITED STATES CALLS BRITTANY GOULD.
JUDGE DAVILA: GOOD AFTERNOON. IF YOU COULD JUST COME FORWARD, PLEASE. IF YOU WOULD FACE OUR COURTROOM DEPUTY HERE AND RAISE YOUR RIGHT HAND, SHE HAS A QUESTION FOR YOU.
(GOVERNMENT'S WITNESS, BRITTANY GOULD, WAS SWORN.)
AUDRA ZACHMAN: YES.
COURT CLERK: THANK YOU.
JUDGE DAVILA: THANK YOU. PLEASE HAVE A SEAT HERE. LET ME INVITE YOU TO MAKE YOURSELF COMFORTABLE. FEEL FREE TO ADJUST THE CHAIR AND MICROPHONE AS YOU NEED.
AUDRA ZACHMAN: SURE.
JUDGE DAVILA: WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME.
AUDRA ZACHMAN: SURE.
JUDGE DAVILA: AND THEN SPELL IT, PLEASE.
AUDRA ZACHMAN: YES. MY NAME IS BRITTANY GOULD, B-R-I-T-T-A-N-Y, G-O-U-L-D.
JUDGE DAVILA: THANK YOU. MR. LEACH, ARE YOU DOING THE EXAMINATION?
MR. LEACH: I AM, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU.
MR. LEACH: MAY I APPROACH THE WITNESS, YOUR HONOR?
JUDGE DAVILA: YES. THANK YOU.
MR. LEACH: (HANDING.) MAY I INQUIRE?
JUDGE DAVILA: PLEASE. /// /// ///