Fabrizio Bonanni — Direct/Cross/Redirect
709 linesDIRECT EXAMINATION BY MS. TREFZ:
MS. TREFZ: GOOD MORNING -- GOOD AFTERNOON, DR. BONANNI.
FABRIZIO BONANNI: GOOD AFTERNOON.
MS. TREFZ: IF YOU ARE FULLY VACCINATED AND YOU'RE COMFORTABLE DOING SO, YOU CAN TESTIFY WITHOUT YOUR MASK.
FABRIZIO BONANNI: THANK YOU.
MS. TREFZ: AND I WILL AS WELL. YOUR HONOR, I'M GOING TO APPROACH AND HAND THE WITNESS THE BINDER.
JUDGE DAVILA: YES.
BY MS. TREFZ:
MS. TREFZ: (HANDING.)
FABRIZIO BONANNI: THANK YOU.
MS. TREFZ: WE MAY OR MAY NOT REFER TO EXHIBITS IN THAT BINDER DURING YOUR EXAMINATION HERE TODAY. DR. BONANNI, IN MAY 2016, DID YOU AGREE TO JOIN THE BOARD OF DIRECTORS OF THERANOS?
FABRIZIO BONANNI: I DID.
MS. TREFZ: AND HOW LONG DID YOU SERVE IN THAT ROLE?
FABRIZIO BONANNI: UNTIL SEPTEMBER 2018. ABOUT TWO AND A HALF YEARS.
MS. TREFZ: AND WE'LL COME BACK TO THAT. BUT JUST FOR THE PURPOSES OF INTRODUCTION, CAN YOU DESCRIBE YOUR EDUCATIONAL BACKGROUND FOR US?
FABRIZIO BONANNI: I HAVE A DOCTORATE IN CHEMISTRY FROM THE UNIVERSITY OF FLORENCE, MY HOME TOWN; AND I SPENT TWO YEARS AT M.I.T. ON A POST DOC ASSIGNMENT; AND I'VE HAD EXECUTIVE COURSES AT HARVARD BUSINESS SCHOOL AND NORTHWESTERN KELLOGG SCHOOL.
MS. TREFZ: AND WHAT DID YOU DO AFTER YOUR POST DOC?
FABRIZIO BONANNI: I SERVED MY TIME IN THE ITALIAN ARMY, AND THEN I JOINED BAXTER INTERNATIONAL IN A SMALL PLANT THAT THEY HAVE OUTSIDE OF FLORENCE.
MS. TREFZ: AND WHAT IS BAXTER INTERNATIONAL?
FABRIZIO BONANNI: BAXTER INTERNATIONAL AT THE TIME WAS A VERY DIVERSIFIED MANUFACTURER, DEVELOPER, SUPPLIER OF HEALTH CARE PRODUCTS. IT HAD DIVISIONS THAT COVERED BLOOD PLASMA PROTEINS, BLOOD TRANSFUSION, RENAL THERAPY PRODUCTS, GENERAL PHARMACEUTICALS, CARDIO VASCULAR DEVICES, AND THEN A LARGE DIAGNOSTICS GROUP.
MS. TREFZ: AND HOW LONG DID YOU WORK AT BAXTER?
FABRIZIO BONANNI: TWENTY-FIVE YEARS.
MS. TREFZ: WHAT --
FABRIZIO BONANNI: AND THREE MONTHS.
MS. TREFZ: AND WHAT ROLES DID YOU SERVE THERE?
FABRIZIO BONANNI: IN MANUFACTURING, QUALITY, OPERATIONS IN GENERAL, AND REGULATORY AFFAIRS AS WELL.
MS. TREFZ: AND DID YOU LEAVE BAXTER IN 1999?
FABRIZIO BONANNI: I DID LEAVE BAXTER IN 1999 TO JOIN AMGEN, WHICH IS THE LARGEST INDEPENDENT BIOTECHNOLOGY COMPANY BASED IN THOUSAND OAKS, CALIFORNIA.
MS. TREFZ: AND HOW LONG DID YOU WORK AT AMGEN?
FABRIZIO BONANNI: ABOUT 14 YEARS.
MS. TREFZ: AND WHAT ROLES DID YOU HOLD THERE?
FABRIZIO BONANNI: I JOINED THE COMPANY AS HEAD OF QUALITY AND COMPLIANCE AND SERVED AS THE FIRST CORPORATE COMPLIANCE OFFICER; AND THEN HEAD OF MANUFACTURING; AND THEN FINALLY HEAD OF OPERATIONS, WHICH INCLUDES MANUFACTURING, QUALITY, ENGINEERING, PROCESS DEVELOPMENT, DRUG DELIVERY DEVICES, ENVIRONMENT HEALTH AND SAFETY, THINGS LIKE THAT.
MS. TREFZ: AND WHAT DID YOU DO BETWEEN THE TIME THAT YOU RETIRED FROM AMGEN AND THE TIME THAT YOU JOINED THE THERANOS BOARD?
FABRIZIO BONANNI: I JOINED TWO BOARDS OF TWO COMPANIES. ONE, STEVANATO GROUP, IS BASED, A COMPANY THAT IS JUST LISTED ON THE NEW YORK STOCK EXCHANGE; AND I ALSO JOINED THE BOARD OF A SMALL BIOTECH COMPANY, XBIOTECH BASED IN TEXAS; AND MENARINI BIOTECH, ANOTHER ITALIAN COMPANY.
MS. TREFZ: SO DID YOU SERVE ON THE BOARD OF VARIOUS BIOTECH COMPANIES BETWEEN THE TIME THAT YOU --
FABRIZIO BONANNI: YEAH, TWO, TWO.
MS. TREFZ: -- RETIRED? AND CAN YOU TURN IN YOUR BINDER TO 10312.
FABRIZIO BONANNI: I'M WITH YOU.
MS. TREFZ: AND LET ME ASK A QUESTION. ARE YOU AT 10312?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WHAT IS 10312?
FABRIZIO BONANNI: IT'S MY CURRICULUM.
MS. TREFZ: AND IS THIS A DOCUMENT THAT YOU PROVIDED TO MS. HOLMES?
FABRIZIO BONANNI: I DID.
MS. TREFZ: AND WHAT IS THE DATE OF -- THIS IS YOUR CURRICULUM VITAE, IS THAT WHAT YOU'RE --
FABRIZIO BONANNI: YES.
MS. TREFZ: AND AS OF AROUND WHAT DATE?
FABRIZIO BONANNI: APRIL 2016.
MS. TREFZ: YOUR HONOR, I WOULD MOVE THE ADMISSION OF 10312.
MR. SCHENK: NO OBJECTION.
JUDGE DAVILA: IS THIS GOING TO BE REDACTED WITH PERSONAL IDENTIFIERS?
MS. TREFZ: IT SHOULD BE. IS IT? YES.
JUDGE DAVILA: IT'S ADMITTED WITH THOSE REDACTIONS.
(DEFENDANT'S EXHIBIT 10312 WAS RECEIVED IN EVIDENCE.)
BY MS. TREFZ:
MS. TREFZ: IF WE CAN PUBLISH IT, PLEASE. AND, DR. BONANNI, DOES THIS CURRICULUM VITAE ACCURATELY SUMMARIZE YOUR EXPERIENCE AS OF APRIL 2016?
FABRIZIO BONANNI: YES, IT DOES.
MS. TREFZ: WE CAN MOVE ON FROM THERE. YOU CAN TAKE THAT DOWN. DR. BONANNI, WERE YOU FIRST INTRODUCED TO THE COMPANY THERANOS IN LATE APRIL 2016?
FABRIZIO BONANNI: I WAS.
MS. TREFZ: AND DESCRIBE HOW YOU WERE INTRODUCED TO THE COMPANY.
FABRIZIO BONANNI: MY FORMER BOSS AT AMGEN, KEVIN SHARER, THE CEO OF AMGEN, WHO AT THE TIME WAS A PROFESSOR AT THE HARVARD BUSINESS SCHOOL, CALLED ME UP AND ASKED ME TO TAKE A CALL FROM SOMEONE IN THIS COMPANY THERANOS BECAUSE HE HAD MET ELIZABETH HOLMES THAT HAD COME TO HARVARD TO SPEAK WITH HIM AND ASK FOR HIS ADVICE, AND HE HAD RECOMMENDED ME AS ONE OF THE PERSONS THAT THEY COULD TALK TO. AND SO THAT WAS THE CONNECTION.
MS. TREFZ: DID YOU HAVE AN UNDERSTANDING OF WHY MR. SHARER RECOMMEND THAT THERANOS TALK TO YOU?
FABRIZIO BONANNI: IN VERY BROAD TERMS. AT THE TIME THAT THERE WERE SOME REGULATORY COMPLIANCE DIFFICULTIES AND SOME OTHER DIFFICULTIES ORIGINATING FROM ARTICLES IN NEWSPAPERS, AND THAT HE THOUGHT THAT I COULD HELP OUT.
MS. TREFZ: AND DID YOU, SOON AFTER THAT INTRODUCTION, DID YOU VISIT THERANOS FOR A MEETING?
FABRIZIO BONANNI: I DID. I THINK IT WAS THE 2ND OF MAY, THE MONDAY. I REMEMBER A MONDAY.
MS. TREFZ: OF 2016?
FABRIZIO BONANNI: 2016, YES.
MS. TREFZ: AND AT THAT MEETING, DID YOU MEET MS. HOLMES?
FABRIZIO BONANNI: I DID.
MS. TREFZ: AND DESCRIBE -- HOW LONG DID YOU SPEND -- WAS THAT MEETING AT THERANOS?
FABRIZIO BONANNI: THE MEETING WAS AT THERANOS IN PALO ALTO.
MS. TREFZ: AND HOW LONG DID YOU SPEND AT THERANOS?
FABRIZIO BONANNI: I SPENT THE WHOLE DAY THERE FROM, I DON'T KNOW, 9:30, 9:00 IN THE MORNING UNTIL 4:30 IN THE AFTERNOON, YEAH.
MS. TREFZ: AND CAN YOU DESCRIBE WHAT -- DESCRIBE AT A HIGH LEVEL WHAT HAPPENED AT THAT MEETING, AND THEN WE MAY BREAK IT DOWN.
FABRIZIO BONANNI: YOU KNOW, I WAS INTRODUCED TO WHAT THE COMPANY WAS ABOUT, WHAT THE TECHNOLOGY LOOKED LIKE. I VISITED THE FACILITY AND TOURED THE DIFFERENT AREAS, AND WE HAD DISCUSSIONS ABOUT WHAT THE VISION WAS ABOUT THE DEPLOYMENT OF THE TECHNOLOGY INTO THE HEALTH CARE SYSTEM. AND THEN, YOU KNOW, WE HAD GENERAL DISCUSSIONS ABOUT THE COMPANY.
MS. TREFZ: DID YOU LEARN ABOUT THE CHALLENGES THAT THE COMPANY WAS FACING?
FABRIZIO BONANNI: I DID, YES.
MS. TREFZ: AND AT THE MEETING, DID YOU HAVE A CHANCE TO SEE THE THERANOS DEVICE?
FABRIZIO BONANNI: I DID.
MS. TREFZ: AND WERE YOU ABLE TO SEE OTHER ASPECTS OF THE TECHNOLOGY THAT THEY HAD DEVELOPED?
FABRIZIO BONANNI: NOT REALLY, NO. NO. JUST THE DEVICE AND THE ANCILLARY COMPONENTS OF THE TECHNOLOGY, YES.
MS. TREFZ: AND BY "ANCILLARY COMPONENTS," WHAT DO YOU MEAN?
FABRIZIO BONANNI: WELL, I MEAN THE TECHNOLOGY CONSISTED AT A VERY HIGH LEVEL OF FOUR COMPONENTS IN MY, IN MY ESTIMATE. ONE IS THE COLLECTION DEVICE FOR THE SAMPLES OF BLOOD FROM A PATIENT, THE CARTRIDGE THAT CONTAINED THE REAGENTS INTO WHICH THE SAMPLE WOULD FIT. AND THEN THE CARTRIDGE ITSELF WOULD GO INSIDE THE MINILAB, MINIATURIZED, YOU KNOW, MACHINE. AND THE MACHINE WOULD BE RUN BY A REMOTE COMPUTER THAT WOULD GIVE IT INSTRUCTIONS ON THE TESTS TO BE PERFORMED AND INTERPRET THE OUTPUT OF THE DATA. SO I DID NOT GET TO SEE THE COMPUTER, FOR INSTANCE, BUT I SAW THE COLLECTION DEVICE AND THE CARTRIDGE AND THE MINILAB.
MS. TREFZ: AND THE MINILAB THAT YOU SAW, DID YOU UNDERSTAND THAT IT WAS THE 4 SERIES MINILAB?
FABRIZIO BONANNI: YES.
MS. TREFZ: OKAY. OVER THE YEARS -- WELL, HOW ABOUT LET ME LIMIT IT TO 2016. DURING 2016, DID YOU LEARN MORE -- DID YOU CONTINUE TO LEARN MORE ABOUT THE CAPABILITIES OF THE DEVICE THAT YOU SAW?
FABRIZIO BONANNI: YES, INDEED, YES.
MS. TREFZ: AND DID YOU FORM AN INITIAL IMPRESSION AT THAT MEETING ABOUT THE, ABOUT THE CAPABILITIES OF THE DEVICE?
FABRIZIO BONANNI: I DID. AND I, I WAS VERY IMPRESSED BY THOSE CAPABILITIES, YES.
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: I'LL ALLOW THAT TO REMAIN. YOU CAN MOVE ON.
MS. TREFZ: I WILL.
MS. TREFZ: I BELIEVE YOU TESTIFIED THAT YOU MET MS. HOLMES AT THAT FIRST MEETING.
FABRIZIO BONANNI: I DID.
MS. TREFZ: AND WHAT, WHAT WAS YOUR IMPRESSION OF MS. HOLMES AT THAT MEETING?
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: SUSTAINED.
BY MS. TREFZ:
MS. TREFZ: DID MS. HOLMES ASK YOU QUESTIONS DURING THAT MEETING?
FABRIZIO BONANNI: VERY MUCH SO.
MS. TREFZ: AND DID YOU PROVIDE ANSWERS -- DID YOU -- HOW LONG WERE YOUR INTERACTIONS WITH MS. HOLMES?
FABRIZIO BONANNI: OH, SEVERAL HOURS.
MS. TREFZ: AT THAT MEETING, DID MS. HOLMES ASK YOU TO TAKE ON A ROLE AT THE COMPANY?
FABRIZIO BONANNI: SHE DID.
MS. TREFZ: AND WHAT, WHAT DID YOU UNDERSTAND HER TO BE ASKING YOU TO TAKE ON?
FABRIZIO BONANNI: THE QUESTION WAS, WOULD I BE WILLING TO JOIN THE COMPANY AND HAVE A SENIOR EXECUTIVE ROLE IN THE COMPANY?
MS. TREFZ: DID SHE -- DID -- WAS A PARTICULAR ROLE COMMUNICATED TO YOU?
FABRIZIO BONANNI: COO.
MS. TREFZ: AND WHAT DID YOU SAY?
FABRIZIO BONANNI: I SAID I WAS TOO OLD FOR THAT.
(LAUGHTER.)
BY MS. TREFZ:
MS. TREFZ: DID YOU, DID YOU NEVERTHELESS OFFER TO TAKE ON A ROLE IN THE COMPANY OTHER THAN COO?
FABRIZIO BONANNI: I DID.
MS. TREFZ: AND DESCRIBE WHAT ROLE YOU OFFERED TO TAKE ON.
FABRIZIO BONANNI: I PROPOSED THAT I JOIN THE BOARD AS A MECHANISM FOR ME TO STAY DIRECTLY INVOLVED WITH THE COMPANY AND OFFER ADVICE ON THE PROPER, YOU KNOW, CONDUCT OF THE COMPANY.
MS. TREFZ: AND DID YOU BELIEVE THAT YOU HAD PARTICULAR EXPERTISE THAT THERANOS WAS IN NEED OF?
FABRIZIO BONANNI: I DID.
MS. TREFZ: WHAT TYPES OF EXPERTISE WAS THAT?
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: SUSTAINED WITHOUT A FOUNDATION.
BY MS. TREFZ:
MS. TREFZ: I BELIEVE YOU TESTIFIED BEFORE THAT YOU, THAT YOU LEARNED ABOUT CERTAIN CHALLENGES THAT THE COMPANY WAS FACING IN THAT MEETING THAT YOU HAD ON MAY 2ND; CORRECT?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WERE THE CHALLENGES -- DID THOSE CHALLENGES INCLUDE REGULATORY CHALLENGES?
FABRIZIO BONANNI: THEY DID.
MS. TREFZ: AND DID THEY INCLUDE OPERATIONAL CHALLENGES?
FABRIZIO BONANNI: THEY DID.
MS. TREFZ: AND WERE BOTH REGULATORY AND OPERATIONAL MATTERS, MATTERS THAT YOU HAD EXPERIENCE IN?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND DID YOU BELIEVE THAT THERANOS WAS IN NEED, OR THAT YOU COULD PROVIDE ADVICE TO THERANOS ON THE -- BASED ON YOUR EXPERIENCE?
FABRIZIO BONANNI: I DID, YES.
MS. TREFZ: WERE YOU PAID FOR YOUR SERVICE ON THE BOARD?
MS. TREFZ: AND I'M SORRY, JUST TO BACK UP. I THINK WE ESTABLISHED YOU SUGGESTED THAT YOU MIGHT BE ABLE TO SERVE AS A BOARD MEMBER. AND WAS THAT -- DID YOU ULTIMATELY AGREE TO JOIN THE BOARD OF DIRECTORS?
FABRIZIO BONANNI: I DID, YES.
MS. TREFZ: AND WAS YOUR APPOINTMENT TO THE BOARD OF DIRECTORS ANNOUNCED SHORTLY AFTER THIS MEETING?
FABRIZIO BONANNI: IT WAS ANNOUNCED SHORTLY AFTER I THINK THE CONSENT. THE DECISION BY THE BOARD WAS ON JUNE 3RD, SO A FEW WEEKS LATER.
MS. TREFZ: DO YOU RECALL WHEN YOUR APPOINTMENT TO THE BOARD OF DIRECTORS WAS ANNOUNCED?
FABRIZIO BONANNI: ON THE 11TH. I THINK THERE WAS A PRESS RELEASE ON THE 11TH OF MAY.
MS. TREFZ: OKAY. AND IF YOU CAN LOOK AT -- IF I COULD JUST DRAW YOUR ATTENTION TO EXHIBIT 7664. ACTUALLY, WE DON'T NEED TO DO THAT. IN ADDITION TO YOU, WAS ANYBODY ELSE ANNOUNCED AS BEING APPOINTED TO THE BOARD OF DIRECTORS AT THE SAME TIME?
FABRIZIO BONANNI: YES. DR. BILL FOEGE AND MR. KOVACEVICH.
MS. TREFZ: AND WHAT WAS DR. FOEGE'S BACKGROUND, IF YOU KNOW?
FABRIZIO BONANNI: HE'S A WELL-KNOWN EPIDEMIOLOGIST WHO WAS A DIRECTOR OF THE CDC FOR A TIME.
MS. TREFZ: AND WHAT WAS MR. KOVACEVICH'S BACKGROUND, IF YOU KNOW?
FABRIZIO BONANNI: HE HAD BEEN THE CEO OF WELLS FARGO BANK.
MS. TREFZ: OKAY. AND DID YOU UNDERSTAND -- DID YOU HAVE AN UNDERSTANDING OF WHETHER EITHER OR BOTH OF THEM HAD A PRIOR RELATIONSHIP WITH THERANOS BEFORE THE ANNOUNCEMENT OF THEIR APPOINTMENT TO THE BOARD OF DIRECTORS?
FABRIZIO BONANNI: YES. DR. FOEGE HAD SERVED ON THE ADVISORY BOARD OF THE COMPANY BEFORE.
MS. TREFZ: AND DO YOU KNOW WHETHER MR. KOVACEVICH HAD?
FABRIZIO BONANNI: I DON'T.
MS. TREFZ: OKAY. DID YOU EVER MEET SUNNY BALWANI?
MS. TREFZ: DID YOU HAVE AN UNDERSTANDING OF THE ROLE THAT SUNNY BALWANI HAD PLAYED AT THE COMPANY PRIOR TO YOUR ARRIVAL?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WHAT WAS THAT ROLE?
FABRIZIO BONANNI: HE WAS COO OF THE COMPANY.
MS. TREFZ: AND WHAT WAS THE STATUS OF MR. BALWANI'S RELATIONSHIP WITH THERANOS AS YOU UNDERSTOOD IT WHEN YOU WERE APPOINTED TO THE BOARD OF DIRECTORS?
FABRIZIO BONANNI: THAT HE WAS LEAVING THE COMPANY OR HAD LEFT THE COMPANY.
MS. TREFZ: OKAY. I THINK WE TALKED BEFORE ABOUT HOW YOU BECAME FAMILIAR WITH THERANOS'S TECHNOLOGY OVER THE COURSE OF 20 -- IN THAT INITIAL MEETING AND THEN OVER THE COURSE OF 2016; IS THAT RIGHT?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND I WANT TO -- AND I THINK YOU DESCRIBED CERTAIN COMPONENTS OF THAT. I WANT TO DRAW YOUR ATTENTION TO EXHIBIT -- WHAT HAS BEEN MARKED AS 7673B, WHICH IS IN YOUR BINDER.
FABRIZIO BONANNI: OKAY.
MS. TREFZ: AND IS 7673B REPRESENTATIVE OF THE DIFFERENT TYPES OF TECHNOLOGY THAT YOU UNDERSTOOD THERANOS HAD DEVELOPED BY THE TIME YOU GOT TO THERANOS?
FABRIZIO BONANNI: YES.
MS. TREFZ: YOUR HONOR, I WOULD OFFER 7673B AS A DEMONSTRATIVE SIMPLY FOR THE PURPOSES OF HELPING EXPLAIN THE DIFFERENT PIECES.
JUDGE DAVILA: NOT INTO EVIDENCE?
MS. TREFZ: CORRECT, JUST AS A DEMONSTRATIVE.
JUDGE DAVILA: ALL RIGHT. THIS CAN BE DISPLAYED AS A DEMONSTRATIVE.
MS. TREFZ: CORRECT.
MS. TREFZ: AND, DR. BONANNI, CAN YOU EXPLAIN YOUR UNDERSTANDING OF THE ROLE OF THE TECHNOLOGIES IDENTIFIED ON 73 -- 7673B IN THE SUITE OF THE THERANOS TECHNOLOGIES, MAYBE PERHAPS FROM THE PERSPECTIVE OF PATIENT EXPERIENCE?
FABRIZIO BONANNI: YES. SO ASSUMING I WOULD GO TO MY PHYSICIAN AND AS I, AS I ENTERED THE OFFICE A NURSE WOULD TAKE A SAMPLE OF A FEW DROPS OF BLOOD THROUGH A FINGERTIP PRICK, AND THEY WOULD BE COLLECTED IN THE SAMPLE COLLECTION DEVICE, THE APPROPRIATE AMOUNT OF ANTICOAGULANT WOULD BE DELIVERED, AND THE BLOOD WOULD COLLECT INTO THOSE SMALL TUBES CALLED NANOTAINER TUBES. THEN THEY WOULD BE PLACED IN A CARTRIDGE, THE SPECIFIC CARTRIDGE FOR THE SET OF TESTS THAT THE DOCTOR WOULD ORDER FOR ME. AND THE CARTRIDGE WOULD BE PUT INTO THE MINILAB WHERE THE TESTS WOULD BE PERFORMED RECEIVING INSTRUCTIONS FROM THE VIRTUAL ANALYZER. THAT'S THE CENTRAL COMPUTER. AND THEN AFTER THE PROTOCOLS ARE RUN, THE COMPUTER WOULD ANALYZE THE OUTPUT AND CONVERT THAT INTO CLINICAL INFORMATION THAT WOULD REACH THE DOCTOR, AND THEN 45 MINUTES LATER WHEN I WOULD SEE THE PHYSICIAN, SHE WOULD HAVE THE APPROPRIATE DIAGNOSTIC INFORMATION AND WE WOULD HAVE A VERY MEANINGFUL CLINICAL DISCUSSION AT THAT POINT. IN ADDITION, THERE WERE ADAPTIONS MADE TO COMMERCIAL ANALYZERS, LIKE THOSE BY SIEMENS AND OTHERS, TO PROCESS THE, THE MINI SAMPLES IN THE NANOTAINER TUBES. SO THAT WAS MY UNDERSTANDING OF THE SITUATION.
MS. TREFZ: OKAY. AND DID -- YOU MENTIONED THE MINILAB. DO YOU SEE THE MINILAB ON THIS DEMONSTRATIVE?
FABRIZIO BONANNI: YES, IT'S THE BOX ON THE BOTTOM RIGHT.
MS. TREFZ: AND WERE YOU FAMILIAR WITH THE COMPONENTS INSIDE OF THE MINILAB, ITS ARCHITECTURE?
FABRIZIO BONANNI: I BECAME FAMILIAR WITH THEM AS IT WAS DEMONSTRATED HOW THEY WORKED OUT, YEAH.
MS. TREFZ: AND WAS THAT DURING 2016 THAT YOU BECAME FAMILIAR?
FABRIZIO BONANNI: YES, YES.
MS. TREFZ: AND IF I COULD DRAW YOUR ATTENTION TO 7673C. DO YOU HAVE THAT IN FRONT OF YOU?
FABRIZIO BONANNI: YES, I DO.
MS. TREFZ: AND IS EXHIBIT 7673C AN ACCURATE REPRESENTATION OF THE 4 SERIES MINILAB AS YOU UNDERSTOOD IT IN 2016?
FABRIZIO BONANNI: YES.
MS. TREFZ: YOUR HONOR, I WOULD ASK AGAIN TO DISPLAY FOR DEMONSTRATIVE PURPOSES EXHIBIT 7673C.
JUDGE DAVILA: NOT INTO EVIDENCE, JUST FOR DEMONSTRATIVE PURPOSES?
MS. TREFZ: AGAIN, YES, YOUR HONOR.
JUDGE DAVILA: IT MAY BE DISPLAYED FOR THAT PURPOSE.
BY MS. TREFZ:
MS. TREFZ: ALL RIGHT. DR. BONANNI, WHAT I WOULD LIKE TO DO HERE IS THAT I WOULD LIKE TO WALK THROUGH THE DIFFERENT COMPONENTS THAT WE SEE ON THE SCREEN. IN PARTICULAR, LET'S START WITH THE BOTTOM LEFT WITH THE CARTRIDGE. WHAT DID YOU UNDERSTAND THAT TO BE?
FABRIZIO BONANNI: SO THE CARTRIDGE IS CUSTOMIZED FOR A SPECIFIC SET OF TESTS TO BE PERFORMED ON THE SAMPLE. SO IT WOULD CONTAIN THE REAGENTS TO PERFORM THOSE TESTS, THE PIPET TIPS, AND OTHER COMPONENTRY THAT MAY BE NEEDED TO RUN THOSE ASSAYS INSIDE OF THE MACHINE.
MS. TREFZ: OKAY. AND WERE THERE COMPONENTS INSIDE OF THE MINILAB THAT WERE -- WOULD ALLOW THE MINILAB TO PERFORM HEMATOLOGY ASSAYS?
FABRIZIO BONANNI: YES, INDEED. YOU KNOW, THERE IS A MINIATURIZED CENTRIFUGE TO THE FAR RIGHT, THERE'S A CYTOMETER, WHICH IS A SPECIALIZED INSTRUMENT TO IMAGE THE CELLS COMPONENT OF THE BLOOD.
MS. TREFZ: AND WERE THERE COMPONENTS THAT WOULD ALLOW THE MINILAB TO PERFORM IMMUNOASSAYS?
FABRIZIO BONANNI: THERE ARE, INDEED.
MS. TREFZ: AND WHICH ARE THOSE?
FABRIZIO BONANNI: THEY WOULD INCLUDE THE -- WELL, THERE IS A ROBOT INSIDE THAT WOULD MAKE IT PERFORM A NUMBER OF MIXINGS AND REACTIONS. THERE'S AN LUMINOMETER HERE. THAT IS SOMETHING THAT WOULD MEASURE THE LIGHT EMITTED THROUGH CHEMILUMINESCENCE DURING CERTAIN REACTIONS, AND IT'S A HIGH SENSITIVITY INSTRUMENT.
MS. TREFZ: AND WERE THERE COMPONENTS THAT WOULD ALLOW THE MINILAB TO PERFORM CLINICAL CHEMISTRY ASSAYS?
FABRIZIO BONANNI: YES, INDEED. AGAIN, THE ROBOT AND THE VARIOUS PROCESSING AND THE MIXING OF REAGENTS, AND THEN THEY WOULD BE TAKEN TO THE SPECTROPHOTOMETER, WHICH IS A VISUAL -- A VISIBLE AND ULTRAVIOLENT LIGHT SPECTROPHOTOMETER THAT WOULD MEASURE THE INTENSITY OF COLORS GENERATED DURING THE REACTIONS DURING THOSE ASSAYS AND CORRELATE THAT TO THE AMOUNT OF THE ANALYTES IN THE SAMPLE.
MS. TREFZ: AND WERE THERE COMPONENTS THAT WOULD ALLOW THE MINILAB TO PERFORM MICROBIOLOGY ASSAYS? WERE THERE COMPONENTS IN THAT --
FABRIZIO BONANNI: THEY'RE NOT MICROBIOLOGY. MOLECULAR BIOLOGY.
MS. TREFZ: I'M SORRY. MOLECULAR BIOLOGY.
FABRIZIO BONANNI: MOLECULAR BIOLOGY, YES. THERE WOULD BE THINGS LIKE THE THERMOCYCLER THAT WOULD ALLOW THE NUCLEIC ACIDS TO EXPAND, AND THE DETECTOR, THE FLUORESCENCE-BASED DETECTOR OVER THERE, YES.
MS. TREFZ: AND I THINK YOU MENTIONED A ROBOT. WE CAN'T SEE IT ON THE SCREEN, BUT WAS THERE ALSO A ROBOT INSIDE OF THE MINILAB?
FABRIZIO BONANNI: RIGHT, THERE'S A ROBOT THAT HANDLES, THAT PERFORMS THE DIFFERENT OPERATIONS THAT ARE NEEDED FOR THE ASSAYS. THERE IS ALSO A CAMERA THERE THAT WE HAVE NOT MENTIONED THAT WAS SOMETHING THAT WAS USED TO VERIFY THE INTEGRITY OF THE SAMPLES, MAKE SURE THERE WAS NOTHING THAT WAS WRONG. YOU KNOW, IF YOU DO HEMATOLOGY, THERE WOULD BE NO HEMOLYSIS IN THE THINGS. SO THERE WAS AN INSIDE, YOU KNOW, CONTROL CHECK FOR THE VARIOUS OPERATIONS OF THE MACHINE.
MS. TREFZ: AND WHILE YOU WERE A BOARD MEMBER AT THERANOS, IN PARTICULAR IN 2016, DID YOU HAVE THE OPPORTUNITY TO SEE THE MINILAB IN ACTION, TO SEE IT RUNNING ASSAYS?
FABRIZIO BONANNI: YES, YES, I DID.
MS. TREFZ: AND HAVE YOU HAD THE CHANCE, PRIOR TO YOUR TESTIMONY TODAY, TO REVIEW CERTAIN CLIPS THAT I'M MARKING FOR IDENTIFICATION PURPOSES AS 9819A THROUGH 9819D?
FABRIZIO BONANNI: I DID. THEY'RE ON YOUTUBE, SO I SAW THEM, YES.
MS. TREFZ: AND DID YOU REVIEW THESE SPECIFIC CLIPS THAT, THAT I'M GOING TO INTRODUCE TODAY?
FABRIZIO BONANNI: YES, I DID.
MS. TREFZ: ATTEMPT TO INTRODUCE?
FABRIZIO BONANNI: YES, I DID.
MS. TREFZ: AND DID 9819A THROUGH 9819D ACCURATELY REFLECT YOUR MEMORY OF HOW THE TSPU PERFORMED CERTAIN FUNCTIONS?
FABRIZIO BONANNI: I DON'T HAVE THAT.
MS. TREFZ: IT'S THE CLIPS.
FABRIZIO BONANNI: OH, THE CLIPS. YES.
MS. TREFZ: AND AGAIN, FOR DEMONSTRATIVE PURPOSES, YOUR HONOR, WE WOULD PURPORT TO -- OR WE WOULD REQUEST TO BE ABLE TO DISPLAY FOR THE JURY, NOT ADMITTED INTO EVIDENCE, BUT DISPLAY FOR THE JURY CERTAIN CLIPS, AND I'LL ASK QUESTIONS ABOUT EACH ONE. BUT I JUST WANTED TO LET THE COURT KNOW WHAT I'M INTENDING TO DO.
JUDGE DAVILA: ARE THESE -- HOW MANY ARE THERE?
MS. TREFZ: THERE ARE FOUR. THEY ARE A TOTAL OF 1 MINUTE AND 51 SECONDS. THEY'RE CLIPS OF 11 SECONDS, 12 SECONDS, 49 SECONDS, AND 38 SECONDS.
JUDGE DAVILA: AND YOU INTEND TO PLAY EACH ONE AND TALK THE WITNESS THROUGH THE CLIP; RIGHT?
MS. TREFZ: THE WITNESS WILL EXPLAIN IT TO US, BUT YES.
JUDGE DAVILA: ALL RIGHT. ALL RIGHT. THAT'S FINE. THEY'RE DEMONSTRATIVE ONLY, AND YOU'LL IDENTIFY WHICH ONE IS PLAYING.
MS. TREFZ: CORRECT. AND LET'S FIRST START WITH 9819A IF WE CAN. THIS IS AN 11 SECOND VIDEO, AND THERE'S NO SOUND. AND IF WE CAN PLAY THAT?
MR. DOWNEY: YOUR HONOR, MAY I JUST ASK MS. TREFZ SOMETHING?
JUDGE DAVILA: YES.
MS. TREFZ: I GUESS THE QUESTION IS, SHOULD WE DO THIS OR SHOULD WE TAKE A BREAK NOW, YOUR HONOR?
JUDGE DAVILA: DO WE NEED A BREAK NOW? IS NOW A TIME FOR A BREAK?
MS. TREFZ: IT APPEARS WE DO.
JUDGE DAVILA: SO LET'S DO THAT AND WE'LL HOLD OFF THE MOVIES UNTIL AFTER OUR BREAK. WE'LL TAKE 30 MINUTES, A 30 MINUTE BREAK. OKAY.
(RECESS FROM 1:37 P.M. UNTIL 2:10 P.M.)
JUDGE DAVILA: PLEASE BE SEATED. THANK YOU. WE'RE BACK ON THE RECORD. ALL COUNSEL ARE PRESENT. MS. HOLMES IS PRESENT. THE JURY IS PRESENT. THE WITNESS IS ON THE STAND. MS. TREFZ, YOU WOULD LIKE TO CONTINUE?
MS. TREFZ: I WOULD. THANK YOU, YOUR HONOR.
MS. TREFZ: DR. BONANNI, I BELIEVE WHEN WE TOOK OUR BREAK WE WERE ABOUT TO WATCH THE FIRST CLIP THAT I'M PLAYING FOR DEMONSTRATIVE PURPOSES, WHICH IS 9819A. MR. BENNETT. AND WE'RE GOING TO WATCH THE CLIP, AND THEN, DR. BONANNI, I'D LIKE TO ASK YOU WHAT WE HAVE SEEN IN THE CLIP AFTER IT'S DONE.
(VIDEO PLAYING OFF THE RECORD.)
FABRIZIO BONANNI: SO WE SEE A TECHNICIAN TOUCHING THE SCREEN AND INDICATING TO THE MACHINE THAT A CASSETTE IS READY TO BE LOADED. THE CASSETTE IS DRAWN IN, THE CARTRIDGE IS DRAWN IN AUTOMATICALLY BY THE MINILAB. AND AS SOON AS IT'S IN, THE BAR CODE IS READ SO THAT THE MACHINE CAN RECEIVE THE INSTRUCTIONS FROM THE CENTRAL COMPUTER, THE VIRTUAL ANALYZER, AND THE LID IS OPENED.
BY MS. TREFZ:
MS. TREFZ: OKAY. AND --
JUDGE DAVILA: I'M SORRY TO INTERRUPT YOU. PARDON ME. I'M SORRY, MS. TREFZ.
MS. TREFZ: THAT'S OKAY, YOUR HONOR. THANK YOU.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: ALL RIGHT. MS. TREFZ, WOULD YOU LIKE TO CONTINUE? THANK YOU.
MS. TREFZ: YES, PLEASE.
MS. TREFZ: IF YOU DON'T MIND, I'D LIKE TO PLAY THE CLIP ONE MORE TIME NOW THAT WE UNDERSTAND WHAT WAS HAPPENING IN THE CLIP. AND, MR. BENNETT, IF YOU COULD JUST PAUSE IT WHEN IT'S -- I'LL TELL YOU WHEN TO PAUSE IT ACTUALLY. GO AHEAD.
(VIDEO PLAYING OFF THE RECORD.)
MS. TREFZ: GO AHEAD. AND CAN YOU PAUSE IT HERE.
MS. TREFZ: SO, DR. BONANNI, WHAT DO WE SEE DEPICTED IN THIS DEMONSTRATIVE?
FABRIZIO BONANNI: THE TECHNICIAN TOUCHING THE SCREEN INDICATING THAT A CARTRIDGE IS ABOUT TO ARRIVE.
MS. TREFZ: AND DID YOU HAVE AN UNDERSTANDING OF WHETHER THE, OF WHETHER THE TECHNICIAN WOULD TYPE ANY INSTRUCTIONS ON THE SCREEN?
FABRIZIO BONANNI: NO. THERE WERE NO INSTRUCTIONS TO BE TYPED.
MS. TREFZ: THE INSTRUCTIONS -- WELL, WHERE WOULD THE INSTRUCTIONS COME FROM?
FABRIZIO BONANNI: THE INSTRUCTIONS COME FROM THE CENTRAL COMPUTER ONCE THE BAR CODE IS READ ON THE CARTRIDGE.
MS. TREFZ: AND THE CARTRIDGE, JUST SO WE UNDERSTAND IT, IS THAT WHAT THE INDIVIDUAL HAS AND IS HOLDING IN THEIR RIGHT HAND?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND IF YOU COULD FINISH THE CLIP.
(VIDEO PLAYING OFF THE RECORD.)
MS. TREFZ: THANK YOU. THE -- WE'RE GOING TO -- THE NEXT CLIP THAT I'D LIKE TO PLAY, YOUR HONOR, IS 9819B. AGAIN, WE'RE PLAYING THIS FOR DEMONSTRATIVE PURPOSES.
JUDGE DAVILA: ALL RIGHT.
MS. TREFZ: AND IT'S 12 SECONDS.
MS. TREFZ: AND, DR. BONANNI, I WOULD -- LET'S WATCH THE CLIP, AND THEN I WANT -- THEN I'M GOING TO ASK YOU SOME QUESTIONS ABOUT WHAT WE'VE SEEN IN THE CLIP. GO AHEAD.
(VIDEO PLAYING OFF THE RECORD.)
MS. TREFZ: ALL RIGHT. IF YOU COULD PAUSE THERE, MR. BENNETT.
MS. TREFZ: SO, DR. BONANNI, CAN YOU DESCRIBE WHAT WE JUST SAW IN 9819B?
FABRIZIO BONANNI: THE COVER IS REMOVED TO SHOW THE INTERNAL PARTS OF THE DEVICE, AND YOU CAN SEE THE CARTRIDGE WITH THE LID OPENED UP AS I SAID BEFORE.
MS. TREFZ: AND SO JUST SO WE UNDERSTAND IT, IS THIS THE INSIDE OF THE MINILAB?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND ARE -- I THINK A FEW MINUTES AGO, OR EARLIER IN YOUR EXAMINATION WE WERE LOOKING AT DIFFERENT -- AT A DEMONSTRATIVE THAT SHOWED DIFFERENT COMPONENTS OF THE MINILAB THAT YOU DESCRIBED FOR US. DO YOU RECALL THAT?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND DO YOU SEE ANY OF THE COMPONENTS THAT WERE DESCRIBED IN THE EXHIBIT HERE, OR IN THIS DEMONSTRATIVE?
FABRIZIO BONANNI: I CAN SEE THE TOP OF THE MATERIAL HANDLING ROBOT TOWARD THE CENTER OF THIS IMAGE.
MS. TREFZ: OKAY. AND THE ITEM THAT'S OPENED, WHAT IS THAT?
FABRIZIO BONANNI: THAT IS THE CARTRIDGE, THE WHITE THING.
MS. TREFZ: OKAY. AND IS YOUR UNDERSTANDING THAT THE OTHER INSTRUMENTS THAT WE IDENTIFIED BEFORE WOULD BECOME PART OF -- EXCUSE ME, WOULD RESIDE IN THE ARCHITECTURE OF THE MINILAB?
FABRIZIO BONANNI: YES.
MS. TREFZ: LET'S MOVE ON TO THE -- WELL, LET'S FINISH THAT CLIP FIRST OF ALL JUST TO MAKE SURE THAT WE'VE SEEN THE WHOLE THING.
(VIDEO PLAYING OFF THE RECORD.)
BY MS. TREFZ:
MS. TREFZ: NOW LET'S MOVE ON TO 9819C. AND, DR. BONANNI, BEFORE WE PLAY 9819C, WE MENTIONED EARLIER -- YOU MENTIONED EARLIER HEMATOLOGY ASSAYS. DO YOU RECALL THAT?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WHAT -- CAN YOU GIVE AN EXAMPLE OF THE TYPES OF ASSAYS THAT, OR THE TYPES OF TESTS THAT ARE INCLUDED IN HEMATOLOGY?
FABRIZIO BONANNI: IT WOULD BE MEASURING THE CELLS, THE NATURE AND THE NUMBER OF CELLS THAT ARE IN THE BLOOD SAMPLE THROUGHOUT THE PATIENT.
MS. TREFZ: SUCH AS?
FABRIZIO BONANNI: RED BLOOD CELLS, HEMATOCRIT, WHITE CELLS, PLATELETS, AND SO FORTH.
MS. TREFZ: MR. BENNET, IF WE COULD PLAY 9819C. AND, YOUR HONOR, WITH THE COURT'S PERMISSION, AGAIN, FOR DEMONSTRATIVE PURPOSES.
JUDGE DAVILA: YES.
MS. TREFZ: THIS IS A TOTAL OF 49 SECONDS, AND WHAT I'D LIKE TO DO IS FIRST WATCH THE CLIP AND I WOULD LIKE TO HAVE DR. BONANNI EXPLAIN WHAT WE'RE SEEING IN THE CLIP.
(VIDEO PLAYING OFF THE RECORD.)
MS. TREFZ: ACTUALLY, CAN WE GO BACK, MR. BENNETT, TO THE BEGINNING OF THE CLIP. PAUSE THERE. ONE MORE SECOND. PAUSE THERE. THANK YOU.
MS. TREFZ: DR. BONANNI, CAN YOU IDENTIFY -- CAN YOU WALK US THROUGH WHAT WE'RE SEEING IN THE DIFFERENT PIECES OF -- ON THE SCREEN HERE?
FABRIZIO BONANNI: SO WHAT WE SEE, THE BIG WHITE THING IS THE CARTRIDGE OPENED UP WITH THE DIFFERENT REAGENTS IN IT, THE PIPET TIPS, THE SLIDES THAT WILL GO INTO THE CYTOMETER. AND REALIZE THAT THE PERSPECTIVE IS ODD, BECAUSE THIS WHOLE THING IS ABOUT 12 INCHES WIDE. SO THIS IS, YOU KNOW, THIS IS DISTORTED, ENLARGED. BEHIND THE CARTRIDGE WE SEE THE MINIATURIZED CENTRIFUGE WITH FIVE BUCKETS. OVER IT IS THE MATERIAL HANDLING ROBOT THAT WE WILL SEE IN ACTION. AND TO THE LEFT WE HAVE AT THE BOTTOM THE SPECTROPHOTOMETER, AND IN THE CENTER THE CAMERA, THE LUMINOMETER, AND SOME OTHER THINGS.
MS. TREFZ: OKAY. LET'S GO AHEAD AND PLAY THE CLIP, AND AS WE PLAY IT, DR. BONANNI, IF YOU CAN EXPLAIN TO THE JURY WHAT IS -- HOW THE MINILAB IS WORKING ON THESE HEMATOLOGY ASSAY.
(VIDEO PLAYING OFF THE RECORD.)
FABRIZIO BONANNI: SO THE ROBOT IS PICKING UP THE SLIDE THAT IT WILL BRING TO THE CYTOMETER, WHICH IS A FLUORESCENCE MICROSCOPY INSTRUMENT, AND NOW IT IS CENTERED AND ADJUSTED AND WILL DO ITS MEASUREMENT TO IMAGE THE CELLS. THEN IT PICKS UP THE SAMPLE OF THE BLOOD FROM THE NANOTAINER, TAKES IT TO THE CAMERA FOR A QUICK CHECK THAT THERE IS NO HEMOLYSIS, PUTS THE SAMPLE INTO A CENTRIFUGE VESSEL, MOVES IT CAREFULLY INTO THE CENTRIFUGE BUCKET WHERE IT IS GOING TO BE SPUN DOWN FOR, I DON'T KNOW, A FEW MINUTES AT 1300G. THAT'S TO MEASURE THE HEMATOCRIT, THE AMOUNT OF RED CELLS.
BY MS. TREFZ:
MS. TREFZ: AND THAT'S ONE OF THE ASSAYS IN THE --
FABRIZIO BONANNI: THAT'S ONE OF THE ASSAYS IN THE HEMATOLOGY, YES.
MS. TREFZ: THANK YOU. I'M GOING TO SHOW YOU ONE MORE CLIP, WHICH IS 9819D, AND THAT'S GOING TO BE 38 SECONDS. WITH THE COURT'S PERMISSION?
JUDGE DAVILA: YES.
MS. TREFZ: BEFORE I DO, YOUR HONOR, MAY --
MS. TREFZ: OR BEFORE I DO, DR. BONANNI, LET ME ASK YOU, CAN YOU REMIND US WHAT CLINICAL CHEMISTRY MEANS?
FABRIZIO BONANNI: THESE ARE THE, THE BASIC METABOLIC PANEL ASSAYS THAT ARE DONE, YOU KNOW, GLUCOSE AND POTASSIUM AND CALCIUM AND OTHER THINGS THAT YOU DO IN A REGULAR TEST, YOU KNOW, CLINICAL TEST.
MS. TREFZ: AND IS THAT SOMETIMES REFERRED TO AS COLOR CHEMISTRY?
FABRIZIO BONANNI: COLOR CHEMISTRY IS A GOOD ELEMENT OF IT, YES.
MS. TREFZ: OKAY. AND MR. BENNETT, IF WE CAN START ON 9819D. AND, DR. BONANNI, WHAT I'D LIKE TO HAVE YOU DO IS TO EXPLAIN WHAT WE'RE SEEING AS WE SEE IT.
(VIDEO PLAYING OFF THE RECORD.)
FABRIZIO BONANNI: SO THE ROBOT IS DISPENSING REAGENTS, MIXING THEM UP. I THINK THE VIDEO IS ACCELERATED HERE. AND EVENTUALLY PUTS THE SAMPLES INTO A CUVETTE, A REACTION CUVETTE, THAT IS THEN TAKEN TO THE SPECTROPHOTOMETER AND THE INTENSITY OF THOSE COLORS IN EACH ONE OF THE WELLS IS MEASURED BY THE SPECTROPHOTOMETER, AND THEN THE CUVETTE IS BROUGHT BACK INTO THE CARTRIDGE, WHICH IS ONE ELEMENT OF THIS TECHNOLOGY IS THAT ALL OF THE WASTE IS COLLECTED BACK INTO THE CARTRIDGE. NOTHING IS LEFT INTO THE MINILAB, WHICH CAN THEN BE USED FOR THE NEXT SAMPLE, AND THE NEXT PATIENT.
MS. TREFZ: CAN YOU REMIND US WHAT THE SPECTROPHOTOMETER DOES?
FABRIZIO BONANNI: IT'S AN INSTRUMENT THAT MEASURES THE INTENSITY OF LIGHT THAT GOES THROUGH THE SAMPLE AT DIFFERENT COLORS AND CORRELATES THAT TO THE AMOUNT OF ANALYTE THAT IS PRESENT IN THE SAMPLE.
MS. TREFZ: AS A PERSON WHO HAD WORKED IN THE MEDICAL DEVICE AND BIO PHARMA INDUSTRY FOR QUITE A WHILE, DID YOU HAVE A VIEW IN 2016 AS TO WHETHER THE THERANOS DEVICE AND TECHNOLOGY HAD POTENTIAL COMMERCIAL USES?
MR. SCHENK: OBJECTION. IMPROPER OPINION TESTIMONY.
JUDGE DAVILA: SUSTAINED.
BY MS. TREFZ:
MS. TREFZ: DID YOU HAVE -- DID YOU HAVE ANY, NOT BASED ON -- STRIKE THAT, YOUR HONOR. DID YOU PERSONALLY ENVISION ANY POTENTIAL USES FOR THE COMMERCIAL -- FOR THE TECHNOLOGY?
MR. SCHENK: OBJECTION. SAME OBJECTION AND RELEVANCE.
JUDGE DAVILA: SUSTAINED.
(PAUSE IN PROCEEDINGS.)
BY MS. TREFZ:
MS. TREFZ: DO YOU RECALL WHETHER THE COMPANY HAD ANY PERSPECTIVE ON THE POTENTIAL COMMERCIAL USES FOR THE TECHNOLOGY?
MR. SCHENK: OBJECTION. RELEVANCE, AND IT CALLS FOR HEARSAY.
JUDGE DAVILA: SUSTAINED WITHOUT A FURTHER FOUNDATION.
BY MS. TREFZ:
MS. TREFZ: DURING YOUR TIME ON THE BOARD OF DIRECTORS, DID YOU COME TO UNDERSTAND, DID YOU COME TO UNDERSTAND -- DID YOU EVER COME TO UNDERSTAND THE POTENTIAL COMMERCIAL USES THAT THE COMPANY WAS DEVELOPING FOR THE TECHNOLOGY?
MR. SCHENK: OBJECTION.
JUDGE DAVILA: SUSTAINED.
MS. TREFZ: OKAY.
MS. TREFZ: DR. BONANNI, WHEN YOU FIRST JOINED THE BOARD IN JUNE 2016, WHAT WAS THE MAKEUP OF THE BOARD?
FABRIZIO BONANNI: AT THAT TIME, SO THERE WAS DR. FOEGE, MR. BOIES, GENERAL MATTIS, RILEY BECHTEL, MR. KOVACEVICH, ELIZABETH HOLMES, AND I. YEAH, I THINK THAT'S IT.
MS. TREFZ: AND DESCRIBE WHAT BOARD MEETINGS WERE LIKE BETWEEN JUNE AND DECEMBER OF 2016 AT A HIGH LEVEL.
FABRIZIO BONANNI: THEY WERE LIVELY DISCUSSIONS. TYPICALLY THE CHAIRMAN, ELIZABETH HOLMES, WOULD INTRODUCE -- YOU KNOW, CALLED THE MEETING TO ORDER AND INTRODUCED THE SUBJECTS AND THE AGENDA, AND THEN DIFFERENT PEOPLE FROM THE COMPANY, AND SOMETIMES OUTSIDE OF THE COMPANY, WOULD COME IN AND MAKE PRESENTATIONS, AND THE BOARD MEMBERS WOULD ASK QUESTIONS, AND HAVE GOOD DISCUSSIONS ABOUT THE SUBJECTS.
MS. TREFZ: WERE -- WAS MS. HOLMES THE ONLY SPEAKER IN THE MEETINGS?
MS. TREFZ: WAS THERE SPIRITED DISCUSSION IN YOUR EXPERIENCE?
FABRIZIO BONANNI: YES, LIVELY DISCUSSIONS.
MS. TREFZ: WERE THERE SOMETIMES DEBATES OVER STRATEGY?
FABRIZIO BONANNI: THERE WERE.
MS. TREFZ: WERE THERE AREAS OF THE COMPANY BETWEEN JUNE AND DECEMBER OF 2016 THAT YOU WERE PARTICULARLY ACTIVE IN?
FABRIZIO BONANNI: YES, THE STRENGTHENING OF THE QUALITY MANAGEMENT SYSTEM AND THE CREATION OF A CORPORATE COMPLIANCE PROGRAM IN PARTICULAR.
MS. TREFZ: DID YOU UNDERSTAND MS. HOLMES TO SEEK YOUR ADVICE ON THOSE AREAS?
FABRIZIO BONANNI: SHE DID.
MS. TREFZ: IN YOUR OPINION, DID MS. HOLMES LISTEN TO AND IMPLEMENT YOUR ADVICE?
FABRIZIO BONANNI: SHE DID.
MS. TREFZ: DID YOU ALSO UNDERSTAND THAT OTHERS ON THE BOARD OF DIRECTORS ADVISED MS. HOLMES ON VARIOUS ASPECTS OF THE COMPANY?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WHAT ROLE DID YOU UNDERSTAND THAT MR. BOIES HAD?
FABRIZIO BONANNI: OH, MR. BOIES, SPECIFICALLY, HIS FIRM WAS REPRESENTING THERANOS ON A NUMBER OF SUBJECTS, YES.
MS. TREFZ: DID -- WAS MR. BECHTEL A MENTOR TO MS. HOLMES AS FAR AS YOU UNDERSTOOD?
FABRIZIO BONANNI: FROM MY STANDPOINT HE WAS, YES.
MS. TREFZ: AND WHAT ABOUT GENERAL MATTIS, DID HE -- WAS HE A MENTOR TO MS. HOLMES DURING THIS TIME PERIOD AS WELL?
FABRIZIO BONANNI: I THINK SO, YES.
MS. TREFZ: WHEN YOU JOINED THE BOARD, DID YOU UNDERSTAND THAT THERANOS WAS FACING PUBLIC CRITICISM AND QUESTIONS ABOUT THE STATE OF ITS TECHNOLOGY?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WAS THERE DEBATE ABOUT HOW TO -- HOW BEST TO RESPOND TO THOSE CRITICISMS IN THE BOARD OF DIRECTORS?
FABRIZIO BONANNI: YES.
MS. TREFZ: DESCRIBE THE NATURE OF THE DEBATE AS YOU UNDERSTOOD IT.
FABRIZIO BONANNI: THE NATURE -- A NUMBER OF DIRECTORS WERE CONVINCED THAT THE COMPANY SHOULD COUNTER THE ALLEGATIONS MADE IN THE PRESS WITH DISCLOSURES, PRESS RELEASES, AND WITH A GENERATION OF DATA SUPPORTING THE EFFECTIVENESS OF THE TECHNOLOGY BY REPUTABLE INSTITUTIONS LIKE THE CLEVELAND CLINIC AND UCSF AND SO FORTH.
MS. TREFZ: IS THAT A VIEW THAT YOU SHARED?
FABRIZIO BONANNI: NO. MY VIEW WAS THAT THE VALIDATION THAT MATTERED IN THIS WHOLE DISCUSSION WAS THAT OBTAINED BY FDA AND OTHER REGULATORY AGENCIES, AND THAT THE COMPANY SHOULD PURSUE -- WITH A VERY HIGH FOCUS ON THE PURSUIT OF CLEARANCE BY FDA AND BY THE EUROPEANS IN PARTICULAR.
MS. TREFZ: IS THAT THE APPROACH THAT THERANOS DECIDED TO FOLLOW?
FABRIZIO BONANNI: YES.
MS. TREFZ: DID THERANOS END UP PUBLISHING ANY PEER REVIEWED ARTICLES?
FABRIZIO BONANNI: YES, THEY DID.
MS. TREFZ: TOWARD THE END OF 2016, WERE THERE SOME CHANGES TO THE MAKEUP OF THE BOARD OF DIRECTORS?
FABRIZIO BONANNI: YES.
MS. TREFZ: DID YOU UNDERSTAND THAT MR. BECHTEL STEPPED DOWN?
FABRIZIO BONANNI: HE DID, YES.
MS. TREFZ: AND DID YOU HAVE AN UNDERSTANDING AS TO WHY, AT A HIGH LEVEL, HE STEPPED DOWN?
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: SUSTAINED.
BY MS. TREFZ:
MS. TREFZ: DID YOU HAVE AN UNDERSTANDING OF WHETHER MR. BECHTEL REMAINED SUPPORTIVE OF THE COMPANY AND MS. HOLMES AFTER HIS DEPARTURE?
MR. SCHENK: OBJECTION. RELEVANCE AND HEARSAY.
JUDGE DAVILA: SUSTAINED.
BY MS. TREFZ:
MS. TREFZ: DID YOU HAVE AN UNDERSTANDING AS TO WHY GENERAL MATTIS STEPPED DOWN AT THE END OF 2016?
MR. SCHENK: OBJECTION. SAME.
MS. TREFZ: YOUR HONOR, I WOULD SAY IN THIS PARTICULAR CIRCUMSTANCE WE HAVE HAD TESTIMONY ABOUT THIS.
JUDGE DAVILA: AND IF HE'S AWARE OF THE REASONS FOR GENERAL MATTIS LEAVING? IS THAT WHAT YOU'RE ASKING?
MS. TREFZ: YEAH, DID HE HAVE AN UNDERSTANDING.
JUDGE DAVILA: OKAY. DO YOU UNDERSTAND THAT QUESTION, SIR?
FABRIZIO BONANNI: I DO.
JUDGE DAVILA: YOU CAN ANSWER THAT.
FABRIZIO BONANNI: MY UNDERSTANDING WAS THAT IT WAS PART OF HIS GETTING PREPARED FOR THE CONFIRMATION HEARINGS IN THE SENATE, AND THAT PART OF THAT PREPARATION WAS TO DISENGAGE HIMSELF FROM ACTIVITIES SUCH AS THE PRESENCE AS A DIRECTOR OF THERANOS.
BY MS. TREFZ:
MS. TREFZ: DID GENERAL MATTIS, OR LATER SECRETARY MATTIS, EVER TELL YOU THAT HE LEFT OVER CONCERNS ABOUT INTEGRITY?
MS. TREFZ: DID HE EVER TELL YOU THAT HE WAS CONCERNED MS. HOLMES HAD MISREPRESENTED TO HIM THE CAPABILITY OF THE TECHNOLOGY?
MS. TREFZ: DID HE EVER TELL YOU THAT HE WAS CONCERNED THAT MS. HOLMES HAD MISREPRESENTED TO HIM WHAT TECHNOLOGY WAS IN THE CLINICAL LABORATORY?
MS. TREFZ: DID ANY OF THE BOARD MEMBERS THAT PREDATED YOUR ARRIVAL TELL YOU THAT THEY WERE CONCERNED THAT MS. HOLMES HAD MISREPRESENTED TO THEM THE CAPABILITIES OF THERANOS'S TECHNOLOGY?
MS. TREFZ: COMING INTO AND EARLY IN YOUR SERVICE ON THE BOARD, WHAT DID YOU UNDER -- STRIKE THAT. BEGINNING IN JUNE OF 2016 WHEN YOU JOINED THE BOARD OF DIRECTORS AND THROUGHOUT AT LEAST THE FOLLOWING SIX MONTHS, WERE EFFORTS MADE TO STRENGTHEN THE POLICIES, SYSTEMS, AND PERSONNEL AT THERANOS?
FABRIZIO BONANNI: MAJOR EFFORTS, YES.
MS. TREFZ: WAS MS. HOLMES SUPPORTIVE OF THOSE EFFORTS?
FABRIZIO BONANNI: YES, VERY MUCH.
MS. TREFZ: DID SHE ENSURE THAT THESE EFFORTS COULD PROCEED WITHOUT DELAY?
FABRIZIO BONANNI: DEFINITELY.
MS. TREFZ: DID SHE COMMIT RESOURCES TO THOSE EFFORTS?
FABRIZIO BONANNI: YES.
MS. TREFZ: I'D LIKE TO TALK ABOUT A FEW PARTICULAR CHANGES THAT WERE MADE BETWEEN JUNE AND DECEMBER OF 2016. ACTUALLY, BEGINNING A LITTLE BEFORE THAT, WERE YOU AWARE WHEN YOU JOINED THE BOARD THAT JUST BEFORE YOU JOINED, THERANOS, THE COMPANY, HAD CREATED A SCIENTIFIC AND MEDICAL ADVISORY BOARD?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND DID YOU HAVE AN UNDERSTANDING OF WHO WAS ON THAT BOARD?
FABRIZIO BONANNI: I DID. PARTICULARLY I KNEW ONE PERSON, DR. SUE EVANS, SHE HAD BEEN A COLLEAGUE OF MINE AT BAXTER WHERE SHE WAS IN CHARGE OF R&D FOR DIAGNOSTICS AND HAD PLAYED A LEADERSHIP ROLE IN THE PROFESSIONAL ASSOCIATION FOR CLINICAL CHEMISTRY. AND OTHER MEMBERS WERE SIMILAR, YOU KNOW, EXPERTS EITHER FROM ACADEMIA OR INDUSTRY, IN THE BROAD AREAS OF CLINICAL CHEMISTRY.
MS. TREFZ: AND DID YOU HAVE AN UNDERSTANDING OF THE -- AS A BOARD MEMBER OF THE PURPOSE OF THE SCIENTIFIC AND MEDICAL ADVISORY BOARD?
FABRIZIO BONANNI: TO SERVE AS A SOUNDING BOARD FOR THE INTERNAL DEVELOPMENT OF THE TECHNOLOGIES INSIDE OF THERANOS, TO HELP IN THE PREPARATION OF PEER REVIEWED ARTICLES, AND BE GENERAL, YOU KNOW, SCIENTIFIC ADVISORS TO THE COMPANY.
MS. TREFZ: AND DID YOU UNDERSTAND THAT THE MEMBERS OF THE SCIENTIFIC AND MEDICAL ADVISORY BOARD WERE OUTSIDERS TO THERANOS?
FABRIZIO BONANNI: YES.
MS. TREFZ: WAS DR. FOEGE ALSO INVOLVED IN THE SCIENTIFIC AND MEDICAL ADVISORY BOARD?
FABRIZIO BONANNI: HE WAS, YES.
MS. TREFZ: AND SO HE WAS --
FABRIZIO BONANNI: AND SO HE WAS AN INTERNAL PERSON I GUESS, YES.
MS. TREFZ: OTHERWISE WERE THE PEOPLE ON THE BOARD OUTSIDERS FROM THE COMPANY?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WERE YOU AWARE THAT LATER IN 2016 THERANOS DEVELOPED A TECHNICAL ADVISORY BOARD?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WHAT IS YOUR UNDERSTANDING OF THE FOCUS OF THAT BOARD?
FABRIZIO BONANNI: THEY WERE MORE -- IT WAS MORE COMPOSED FROM EXPERTS IN ENGINEERING AND BIOENGINEERING AND PEOPLE THAT WOULD BE ADVISORS IN THE DEVELOPMENT OF THE ENGINEERING ELEMENTS OF THE TECHNOLOGY ITSELF, NOT THE MEDICAL PART.
MS. TREFZ: AND FOR THE MOST PART, WERE THE MEMBERS OF THE TECHNICAL ADVISORY BOARD ALSO OUTSIDERS TO THERANOS?
FABRIZIO BONANNI: YES.
MS. TREFZ: WAS DR. CHANNING ROBERTSON ALSO A MEMBER?
FABRIZIO BONANNI: HE WAS.
MS. TREFZ: AND DID YOU UNDERSTAND WHETHER DR. ROBERTSON HAD A PRIOR ASSOCIATION WITH THERANOS?
FABRIZIO BONANNI: I UNDERSTOOD HE HAD, YES, FROM THE VERY BEGINNING, YES.
MS. TREFZ: WAS ONE MAJOR TASK YOU ADVISED ON INCREASING QUALITY AND COMPLIANCE FUNCTIONS AT THERANOS?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND I WANT TO, I WANT TO EXPLORE EACH OF THOSE DIFFERENT PIECES. FIRST, CAN YOU DESCRIBE WHAT YOU MEAN BY COMPLIANCE FUNCTION?
FABRIZIO BONANNI: SO IN GENERAL TERMS?
MS. TREFZ: CORRECT.
FABRIZIO BONANNI: THAT WOULD LEAD ME TO THE CORPORATE COMPLIANCE PROGRAM. THAT IS A COLLECTION OF PROCESSES AND PROCEDURES TO MAKE SURE THAT EVERYBODY IN A COMPANY UNDERSTANDS THE EXPECTATIONS AND THE REQUIREMENTS ON HOW TO COMPLY WITH LAWS AND REGULATIONS THAT APPLY TO THAT COMPANY, TO THAT BUSINESS. AND PEOPLE ARE TRAINED IN THOSE REQUIREMENTS; THAT THEY ARE AUDITED; THAT THEY PERFORM AS INTENDED; AND THAT THERE ARE CHANNELS OF COMMUNICATION BETWEEN STAFF AND MANAGEMENT ABOUT OBSERVATIONS OF NONCONFORMANCE, NONCOMPLIANCE BEHAVIORS THAT ARE AGAINST LAWS AND REGULATIONS, AND THAT THOSE REPORTS ARE ACTED UPON BY AN APPROPRIATE MECHANISM OF INVESTIGATIONS AND SO FORTH. SO THAT'S THE BROADER ELEMENT OF COMPLIANCE THAT WE DID START IN THE COMPANY DURING THAT SUMMER.
MS. TREFZ: AND WHAT SUMMER WAS THAT?
FABRIZIO BONANNI: 2016.
MS. TREFZ: THANK YOU. AND WITH RESPECT TO QUALITY FUNCTIONS OF THE COMPANY, WHAT ARE THOSE AS FAR AS YOU UNDERSTAND?
FABRIZIO BONANNI: I REFER TO THE QUALITY MANAGEMENT SYSTEM, WHICH IS A COLLECTION OF, AGAIN, PROCESSES AND PROCEDURES THAT ARE DESIGNED TO MAKE SURE THAT THE OUTPUT OF THE COMPANY IS RELIABLE, THAT THE DATA GENERATED HAVE INTEGRITY AND CAN BE RELIED UPON. I'LL GIVE YOU EXAMPLES. THE SIMPLEST THING TO THINK ABOUT IS EVERY INSTRUMENT THAT IS USED TO TAKE ANY MEASUREMENT SHOULD BE CALIBRATED AGAINST RECOGNIZED STANDARDS, AND THAT THEN THOSE DATA GENERATED SHOULD BE DOCUMENTED IN A CERTAIN FASHION; THAT PEOPLE SHOULD BE TRAINED IN WHAT THEY DO, AND IF THEY'RE NOT TRAINED, THEY SHOULD NOT BE ALLOWED TO PERFORM THOSE TASKS. FOR DEVICES, THE REGULATION -- SO THIS AREA IS COVERED BY SOMETHING CALLED QUALITY SYSTEM REGULATION IN THE U.S. THAT COVERS ALSO ASPECTS OF DEVELOPMENT, NOT JUST MANUFACTURING. SO THERE ARE DESIGN CONTROLS ON HOW THE DEVICE SHOULD BE DESIGNED, DEVELOPED, AND THE OUTPUT DOCUMENTED AND VERIFIED AND VALIDATED AND SO FORTH. SO THAT BODY -- THERE WERE ELEMENTS OF THAT SYSTEM IN PLACE AT THERANOS AS I FIRST VISITED. THEY NEEDED TO BE STRENGTHENED AND MADE MORE COMPLETE.
MS. TREFZ: AND DID YOU HAVE EXPERIENCE WITH THOSE TYPES OF FUNCTIONS FROM YOUR PRIOR WORK AT AMGEN AND BAXTER?
FABRIZIO BONANNI: I DID.
MS. TREFZ: AS PART OF YOUR EFFORTS TO STRENGTHEN THESE ASPECTS OF THE COMPANY, DID THERANOS HIRE ADDITIONAL PERSONNEL?
FABRIZIO BONANNI: YES. IMMEDIATELY THERANOS HIRED A HEAD OF QUALITY AND REGULATORY AFFAIRS, AND ALSO A HEAD OF CORPORATE COMPLIANCE. AND IN RECORD TIME I SHOULD ADD, BECAUSE BY MID-JULY, MID, END JULY 2016 THEY WERE RECRUITED AND ON BOARD.
MS. TREFZ: AND DID THERANOS ALSO HIRE OUTSIDE CONSULTANTS TO ASSIST IN THOSE EFFORTS AS WELL?
FABRIZIO BONANNI: YES, IN TWO WAYS. CONSULTANTS TO SERVE AS CONSULTANTS TO THE COMPANY, BUT WE ADDED TWO PROFESSIONALS IN THOSE FIELDS TO PUT INTO A COMMITTEE OF THE BOARD THAT WE CREATED TO COVER QUALITY AND COMPLIANCE.
MS. TREFZ: AND WAS -- DO YOU RECALL WHEN THAT QUALITY AND COMPLIANCE, OR COMPLIANCE AND QUALITY COMMITTEE OF THE BOARD OF DIRECTORS WAS ANNOUNCED?
FABRIZIO BONANNI: I DO NOT.
MS. TREFZ: LET ME SEE IF I CAN JUST REFRESH YOUR RECOLLECTION. CAN YOU TURN TO 7671 IN YOUR BINDER. AND DON'T READ IT OUTSIDE -- OR OUT LOUD. I'M JUST TRYING TO REFRESH YOUR RECOLLECTION.
FABRIZIO BONANNI: YES. SO IT IS ON THE 20TH OF JULY. IT'S THE SAME ANNOUNCEMENT THAT ANNOUNCED THE JOINING OF MR. WURTZ AND MR. GUGGENHEIM INTO THE COMPANY. IT ALSO ANNOUNCED THE CREATION OF THE COMMITTEE, OF THE BOARD, AND THAT WAS COMPOSED OF DR. FOEGE AND ME, WITH TWO EXTERNAL EXPERTS TO HELP US.
MS. TREFZ: AND YOU MENTIONED MR. WURTZ. WHAT ROLE DID HE SERVE?
FABRIZIO BONANNI: HE JOINED IN AS SENIOR VICE PRESIDENT, QUALITY AND REGULATORY.
MS. TREFZ: AND WHAT ABOUT MR. GUGGENHEIM?
FABRIZIO BONANNI: AS CHIEF COMPLIANCE OFFICER.
MS. TREFZ: WAS ONE OF THE STEPS -- I BELIEVE YOU ALLUDED TO THIS EARLIER, BUT JUST TO IDENTIFY IT IN A LITTLE BIT MORE DETAIL, WAS ONE OF THE STEPS YOU WERE INVOLVED IN HELPING TO CREATE A ROBUST QUALITY MANAGEMENT PROGRAM AT THERANOS?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND DID THIS EFFORT TAKE AWHILE TO COMPLETE?
FABRIZIO BONANNI: IT DID. IT IS A COMPLICATED THING TO PUT TOGETHER. SO THE HIGH LEVEL DOCUMENTATION CORPORATE QUALITY MANUAL WAS CREATED RATHER RAPIDLY, WITHIN TWO OR THREE MONTHS, AND THEN IT TOOK, YOU KNOW, THE REST OF A YEAR TO PUT TOGETHER ALL OF THE POLICIES AND PROCEDURES, TRAIN PEOPLE INTO THEM, AND MAKE SURE THAT THEY WERE USED IN PRACTICE IN DAILY OPERATIONS, YES.
MS. TREFZ: AND WAS MS. HOLMES SUPPORTIVE OF THAT EFFORT?
FABRIZIO BONANNI: YES.
MS. TREFZ: DID -- WERE YOU ALSO AWARE THAT UPON YOUR ARRIVAL AT THERANOS, UPON THE TIME YOU JOINED THE BOARD AT THERANOS, WERE YOU AWARE THAT NEW LAB DIRECTORS HAD BEEN HIRED WITHIN THE PAST SIX MONTHS?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WERE THERE OTHER EFFORTS TO HIRE MEMBERS OF THE MANAGEMENT TEAM OUTSIDE OF THE COMPANY, IN PARTICULAR I WANT TO FOCUS ON LATE -- FROM THE TIME THAT YOU JOINED THE BOARD TO THE END OF 2016.
FABRIZIO BONANNI: YES, THERE WERE. THE COMPANY ENDED UP HIRING A HEAD OF OPERATIONS, MCCHESNEY; CHANGED THE GENERAL COUNSEL; AND WAS SEARCHING FOR A CHIEF FINANCIAL OFFICER. THAT DID NOT SUCCEED, BUT INTERVIEWED A NUMBER OF CANDIDATES FOR THAT.
MS. TREFZ: IN WORKING ON THESE EFFORTS, WERE YOU EVER DENIED ACCESS TO INFORMATION THAT WAS IN THERANOS'S FILES?
MS. TREFZ: WERE YOU EVER DENIED THE OPPORTUNITY TO TALK TO SOMEONE THAT YOU WANTED TO SPEAK WITH?
MS. TREFZ: AND WAS -- TO YOUR IMPRESSION, WAS MAKING THESE IMPROVEMENT A FOCUS OF MS. HOLMES?
FABRIZIO BONANNI: IT WAS.
MS. TREFZ: IN AUGUST OF 2016, DID MS. HOLMES PRESENT AT THE ACC CONFERENCE?
FABRIZIO BONANNI: SHE DID.
MR. SCHENK: OBJECTION. RELEVANCE.
MS. TREFZ: THE RELEVANCE IS INTENT AND STATE OF BELIEF OF THE TECHNOLOGY. IF I COULD ASK A COUPLE MORE QUESTIONS, IT MAY BECOME CLEARER.
JUDGE DAVILA: ALL RIGHT. OKAY.
BY MS. TREFZ:
MS. TREFZ: DID YOU UNDERSTAND -- DID YOU HAVE AN UNDERSTANDING AS TO THE PURPOSE OF PRESENTING AT THIS CONFERENCE?
FABRIZIO BONANNI: I DO.
MS. TREFZ: WHAT IS YOUR UNDERSTANDING?
FABRIZIO BONANNI: IT WAS TO OVERCOME THE CRITICISM OF LACK OF TRANSPARENCY THAT THERANOS HAD RECEIVED AT THAT TIME AND TO SHOW WHAT THE TECHNOLOGY WAS ALL ABOUT IN A SCIENTIFIC CONTEXT, AS THAT SCIENTIFIC MEETING WAS.
MS. TREFZ: AND IS YOUR UNDERSTANDING THAT PART OF THIS EFFORT WAS RELATED TO THAT DEBATE THAT YOU WERE DISCUSSING ON THE BOARD OF DIRECTORS -- THAT WAS OCCURRING ON THE BOARD OF DIRECTORS?
FABRIZIO BONANNI: IN A WAY. IN A WAY IT WAS, YES, YES.
MS. TREFZ: DID YOU ASSIST IN THE PREPARATION FOR THE AACC PRESENTATION?
FABRIZIO BONANNI: I DID.
MS. TREFZ: AND DID YOU, DID YOU WATCH IT?
FABRIZIO BONANNI: YES.
MS. TREFZ: DID YOU HAVE A VIEW ON HOW IT WAS RECEIVED?
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: SUSTAINED.
BY MS. TREFZ:
MS. TREFZ: OVER YOUR TIME AS A BOARD MEMBER, DID YOU FORM AN IMPRESSION OF MS. HOLMES'S STRENGTHS AND WEAKNESSES AS A CEO?
FABRIZIO BONANNI: I DID.
MS. TREFZ: AND WHAT WERE HER STRENGTHS?
FABRIZIO BONANNI: HER VISION FOR THE COMPANY; HER TECHNOLOGY SAVVY AND MASTERING OF ALL ASPECTS THAT RELATED TO THE SYSTEM OF TECHNOLOGIES THAT HAD BEEN DEVELOPED; AMOUNT OF ENERGY, ENTHUSIASM, DRIVE THAT SHE HAD TO, TO, YOU KNOW, BRING THIS COMPLICATED THING FORWARD. I ADMIRED HER LACK OF DEFENSIVENESS AND HER WILLINGNESS TO LISTEN TO OTHER PEOPLE'S OPINIONS THAT I THOUGHT WAS REMARKABLE.
MS. TREFZ: CAN YOU EXPLAIN WHAT YOU MEAN BY THAT?
FABRIZIO BONANNI: WHEN PEOPLE HAVE A STRONG SENSE OF OWNERSHIP OVER WHAT THEY'VE DONE AND YOU VENTURE OTHER OPINIONS AND CRITIQUES AND OTHER VIEWS, THEY TEND TO LISTEN AND THEN TO SAY, "YES, BUT" AND DEFEND THEIR PAST DOINGS. AND I NEVER HAD A "BUT" FROM ELIZABETH HOLMES. SHE WAS DILIGENT IN LISTENING AND INTERNALIZING WHAT SHE RECEIVED AS ADVICE FROM A NUMBER OF PEOPLE, INCLUDING ME.
MS. TREFZ: SO WE TALKED ABOUT HER STRENGTHS. WHAT WERE HER WEAKNESSES, IN YOUR VIEW, AS A CEO?
FABRIZIO BONANNI: PERHAPS THE AREA OF FOCUSSING; PERHAPS THE AREA OF BEING INCREDIBLY PERSEVERING IN ACHIEVING -- IN BRINGING ONE ELEMENT OF THE HUNDREDS OF ONES THAT WERE IN DEVELOPMENT, BRINGING ONE THROUGH THE GOAL AND THE TARGET OF REGULATORY APPROVAL, AND THE FACT THAT THERE WERE SO MANY DIFFERENT COMPLEX THINGS BEING WORKED ON THAT I THOUGHT COULD HAVE BEEN IMPROVED.
MS. TREFZ: DID YOU HAVE A VIEW ABOUT MS. HOLMES'S SKILLS IN TERMS OF OPERATIONAL MANAGEMENT?
FABRIZIO BONANNI: WELL, THAT'S WHAT I'M REFERRING TO. AND WE BROUGHT IN PEOPLE THAT WOULD HELP IN CREATING THE STRUCTURES THAT ALLOW YOU TO MANAGE DIFFERENT PROGRAMS REQUIRING MULTIDISCIPLINARY EXPERTS TO BE INVOLVED, AND WE BROUGHT IN PEOPLE FROM AMGEN THAT HAD LIVED THROUGH THAT KIND OF PROBLEMATIC, SO --
MS. TREFZ: AND BETWEEN JUNE AND DECEMBER OF 2016, WAS IT YOUR VIEW THAT THERANOS -- DID YOU HAVE A VIEW AS TO WHETHER THERANOS FACED HURDLES IN ITS FUTURE SUCCESS?
MR. SCHENK: OBJECTION. OPINION AND RELEVANCE.
JUDGE DAVILA: IF YOU WANT TO REPHRASE THIS AS TO HIS TIME ON THE BOARD AND HIS SERVICE? IS THAT WHAT YOU'RE --
MS. TREFZ: THAT WAS THE TIME PERIOD THAT I WAS REFERRING TO, YOUR HONOR.
JUDGE DAVILA: WHY DON'T YOU REPEAT THE QUESTION?
BY MS. TREFZ:
MS. TREFZ: BASED ON YOUR EXPERIENCE ON THE BOARD BETWEEN JUNE AND DECEMBER OF 2016, DID YOU HAVE A VIEW AT THAT TIME ABOUT THE HURDLES THAT THERANOS FACED IN MOVING FORWARD AS A COMPANY?
FABRIZIO BONANNI: YES.
MS. TREFZ: WHAT WAS YOUR VIEW?
FABRIZIO BONANNI: WELL, THERE WERE, THERE WERE TWO CATEGORIES FOR ME. ONE WAS THEY -- ENSURING THE FINANCING AND THE FINANCIAL WELL BEING OF THE COMPANY GOING FORWARD; AND THE OTHER ONE WAS, AGAIN, THE ACHIEVEMENT OF REGULATORY EXPERIENCE FOR THE TECHNOLOGY.
MS. TREFZ: AND DID YOU HAVE THE -- DID YOU VIEW -- HAVE A VIEW AS TO WHETHER THE COMPANY HAD A FOUNDATION TO OVERCOME THOSE HURDLES?
FABRIZIO BONANNI: IT DID. YES, I DID.
MS. TREFZ: AND WHAT WAS THE FOUNDATION IN YOUR VIEW?
FABRIZIO BONANNI: WELL, THE FOUNDATION WAS THAT THERE WERE, YOU KNOW, SPECIFIC ASSAYS BEING DEVELOPED AND THE COMPANY FOCUSSED IN ON ONE SPECIFICALLY, THE ONE FOR ZIKA; AND THAT THE COMPANY HAD THE LARGE PORTFOLIO OF PATENTS THAT HAD BEEN CREATED THAT WERE VALUABLE; AND THAT, WITH THE DEMONSTRATION OF COMMERCIAL ABILITY OF THE DEVICE, THE COMPANY WAS IN A GOOD POSITION TO ATTRACT EITHER ADDITIONAL FUNDING OR PARTNERSHIPS WITH INDUSTRIAL PARTNERS.
MS. TREFZ: AND YOU JUST -- YOU WORKED AT THE COMPANY UNTIL ITS END; IS THAT RIGHT?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND WOULD YOU HAVE WORKED AT THERANOS IF YOU DID NOT BELIEVE THAT THE TECHNOLOGY WAS SOUND?
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: SUSTAINED.
MS. TREFZ: ONE MOMENT, YOUR HONOR.
(DISCUSSION AMONGST DEFENSE COUNSEL OFF THE RECORD.)
MS. TREFZ: NO FURTHER QUESTIONS AT THIS TIME.
JUDGE DAVILA: CROSS-EXAMINATION?
CROSS-EXAMINATION BY MR. SCHENK:
MR. SCHENK: GOOD AFTERNOON, DOCTOR. MY NAME IS JEFF SCHENK. IT'S NICE TO MEET YOU.
FABRIZIO BONANNI: GOOD AFTERNOON. IT'S NICE TO MEET YOU.
MR. SCHENK: THERE'S A COUPLE OF TOPICS I'D LIKE TO COVER WITH YOU, BUT THE FIRST IS I'D LIKE TO PICK UP ON A CONVERSATION THAT YOU WERE HAVING WITH MS. TREFZ A MOMENT AGO. SHE WAS ASKING YOU ABOUT THE OPINIONS OF CERTAIN BOARD MEMBERS REGARDING INTEGRITY AND WHETHER THEY HAD DEPARTED THE COMPANY OR THE BOARD BECAUSE OF INTEGRITY CONCERNS. DO YOU RECALL THAT LINE OF QUESTIONING?
FABRIZIO BONANNI: I DO, I DO.
MR. SCHENK: AND I JUST WANT TO BE VERY CLEAR. WHAT YOU WERE TESTIFYING WAS THAT GENERAL MATTIS NEVER TOLD YOU THAT HE HAD THOSE CONCERNS; IS THAT RIGHT?
FABRIZIO BONANNI: YES.
MR. SCHENK: YOU WERE NOT SAYING THAT GENERAL MATTIS DID NOT HAVE THOSE CONCERNS? YOU DON'T KNOW WHETHER HE HAD THOSE CONCERNS, HE JUST DIDN'T EXPRESS THEM TO YOU; CORRECT?
FABRIZIO BONANNI: CORRECT.
MR. SCHENK: OKAY. I WANT TO BE VERY CLEAR ABOUT THAT. YOU SPENT TIME ON THE BOARD BEGINNING IN 2016; IS THAT RIGHT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND THAT STAYED THROUGH YOUR, YOUR SERVICE -- YOUR SERVICE REMAINED THROUGH 2018?
FABRIZIO BONANNI: YES.
MR. SCHENK: SO YOU DID NOT COME HERE TO TESTIFY ABOUT EVENTS THAT OCCURRED AT THERANOS FROM ITS FOUNDING IN 2003 UNTIL MAY OF 2016; IS THAT CORRECT?
FABRIZIO BONANNI: CORRECT.
MR. SCHENK: YOU DON'T HAVE PERSONAL KNOWLEDGE OF THOSE EVENTS; IS THAT CORRECT?
MR. SCHENK: YOU TESTIFIED ABOUT A DEVICE, THE MINILAB, TODAY; IS THAT CORRECT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND ALL OF YOUR TESTIMONY TODAY WAS ABOUT A DEVICE CALLED A MINILAB; IS THAT RIGHT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND WHICH VERSION OF THE MINILAB WAS THAT AGAIN?
FABRIZIO BONANNI: IT WAS, I THINK, 4.2.
MR. SCHENK: OKAY. THAT WAS NEVER USED TO TEST PATIENTS; IS THAT CORRECT?
FABRIZIO BONANNI: COMMERCIALLY? NO.
MR. SCHENK: CORRECT. IT WAS NOT FDA CLEARED; IS THAT RIGHT?
FABRIZIO BONANNI: NO, IT WAS NOT.
MR. SCHENK: SO WHEN THERANOS -- YOU'RE AWARE THAT THERANOS WAS TESTING PATIENTS' BLOOD IN ITS PARTNERSHIP WITH WALGREENS; RIGHT?
FABRIZIO BONANNI: YES.
MR. SCHENK: YOU'RE AWARE THAT THAT HAPPENED EVEN BEFORE YOU ARRIVED; RIGHT?
FABRIZIO BONANNI: YES.
MR. SCHENK: THERANOS DIDN'T USE THE DEVICE THAT YOU TALKED ABOUT TODAY; CORRECT?
FABRIZIO BONANNI: NOT TO MY KNOWLEDGE.
MR. SCHENK: CORRECT. THE DEVICE THAT YOU TALKED ABOUT TODAY WAS NEVER USED COMMERCIALLY TO TEST PATIENTS' BLOOD; CORRECT?
FABRIZIO BONANNI: CORRECT.
MR. SCHENK: AND NO MEDICAL DECISIONS WERE BASED UPON RESULTS GENERATED FROM THE DEVICE THAT YOU TESTIFIED ABOUT TODAY, THE 4.2?
FABRIZIO BONANNI: TO MY KNOWLEDGE, NO.
MR. SCHENK: BECAUSE THAT WOULD HAVE BEEN INAPPROPRIATE. IT WASN'T FDA APPROVED?
FABRIZIO BONANNI: RIGHT.
MR. SCHENK: CORRECT. THERANOS DIDN'T HAVE A CLIA LAB WHEN YOU WERE THERE; CORRECT?
FABRIZIO BONANNI: CAN YOU REPEAT THAT?
MR. SCHENK: DO YOU KNOW WHAT A CLIA LAB IS?
FABRIZIO BONANNI: YES.
MR. SCHENK: DID THERANOS OPERATE A CLIA LAB WHILE YOU WERE THERE?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND DID YOU TALK TO AN INDIVIDUAL NAMED DR. DAS ABOUT THAT?
FABRIZIO BONANNI: I DID.
MR. SCHENK: AND HIS ROLE WAS LAB DIRECTOR; CORRECT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND DR. DAS MADE A DECISION TO VOID PATIENT TESTS, THE RESULTS THAT THERANOS HAD PROVIDED TO PATIENTS IN THE PERIOD OF TIME WHEN IT WAS OPERATING THAT CLIA LAB; CORRECT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND YOU THOUGHT THAT WAS THE CORRECT DECISION. YOU DIDN'T DISAGREE WITH DR. DAS ABOUT THAT?
MS. TREFZ: OBJECTION. FOUNDATION.
JUDGE DAVILA: WELL, HE TESTIFIED HE KNEW ABOUT THAT. OVERRULED. YOU CAN ANSWER, SIR.
FABRIZIO BONANNI: I DID NOT DISAGREE.
BY MR. SCHENK:
MR. SCHENK: YOU THOUGHT IT WAS AN APPROPRIATE DECISION?
FABRIZIO BONANNI: THE DECISION WAS HIS TO MAKE.
MR. SCHENK: DID YOU THINK IT WAS WRONG?
MR. SCHENK: AND THAT WAS BECAUSE THE TECHNOLOGY THAT THERANOS WAS USING, NOT THE 4.2, BUT THE TECHNOLOGY THAT THERANOS WAS USING WAS NOT CAPABLE OF ACCURATELY TESTING PATIENTS; CORRECT?
MS. TREFZ: OBJECTION. FOUNDATION.
JUDGE DAVILA: DO YOU WANT TO JUST LAY SOME FOUNDATION AS TO --
MR. SCHENK: SURE.
JUDGE DAVILA: -- THAT MACHINE THAT YOU'RE TALKING ABOUT?
BY MR. SCHENK:
MR. SCHENK: YOU TOLD ME THAT YOU DIDN'T DISAGREE WITH DR. DAS'S DECISION TO VOID TESTS; CORRECT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND YOU TOLD ME THAT TESTS WERE CONDUCTED ON A DIFFERENT DEVICE, NOT THE 4.2; CORRECT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND YOU ALSO KNOW THAT THE REASON THAT THE TESTS WERE VOIDED HAD TO DO WITH CONCERNS ABOUT WHETHER THOSE TESTS WERE ACCURATE, WHETHER THEY WERE APPROPRIATE FOR PATIENTS AND DOCTORS TO BE MAKING MEDICAL DECISIONS BASED UPON. DO YOU ALSO KNOW THAT?
FABRIZIO BONANNI: YES.
MR. SCHENK: SO THEN MY QUESTION IS, YOU AGREE WITH THE FACT THAT THE OTHER DEVICE, NOT THE 4.2, BUT THE THERANOS DEVICE THAT WAS USED TO TEST PATIENTS BEFORE YOU ARRIVED ON THE BOARD WAS NOT SUITABLE FOR PATIENT TESTING, COULD NOT GENERATE ACCURATE RESULTS. WE BOTH AGREE ON THAT; CORRECT?
FABRIZIO BONANNI: NO. THIS IS A GENERAL STATEMENT THAT YOU'RE MAKING THAT I AM NOT COMFORTABLE AGREEING OR DISAGREEING WITH.
MR. SCHENK: WHICH --
FABRIZIO BONANNI: RESULTS ARE VOIDED FOR SPECIFIC REASONS. IT DOESN'T MEAN THAT THE WHOLE THING IS WRONG.
MR. SCHENK: DID THERANOS VOID EVERY SINGLE EDISON TEST, NOT SPECIFIC REASONS ON IT, BUT IT VOIDED EVERY SINGLE ONE; RIGHT?
FABRIZIO BONANNI: I DON'T KNOW THAT.
MR. SCHENK: HOW LONG WERE YOU ON THE BOARD?
FABRIZIO BONANNI: HOW LONG?
MR. SCHENK: HOW LONG WAS YOUR BOARD SERVICE?
FABRIZIO BONANNI: TWO AND A HALF YEARS.
MR. SCHENK: AND WHEN YOU JOINED THE BOARD, YOU TESTIFIED THAT YOU WERE AWARE OF SOME REGULATORY, AND I THINK YOU ALSO SAID OPERATIONAL CHALLENGES?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND WAS ONE OF THOSE CHALLENGES THAT THERANOS VOIDED ALL OF ITS TESTS? WERE YOU AWARE OF THAT FACT?
FABRIZIO BONANNI: I WAS NOT AWARE THAT THERANOS VOIDED ALL OF ITS TESTS.
MR. SCHENK: EDISON TESTS. YOU WERE NOT AWARE THAT THERANOS VOIDED ALL OF ITS EDISON TESTS?
FABRIZIO BONANNI: NO, I WAS NOT.
MR. SCHENK: DOES NOW KNOWING THAT FACT CHANGE SOME OF THE TESTIMONY THAT YOU GAVE ON DIRECT?
MR. SCHENK: HELP ME UNDERSTAND THAT. WHAT DO YOU STILL FEEL --
FABRIZIO BONANNI: I JOINED THE COMPANY TO INFLUENCE THE FUTURE OF THE COMPANY. I DID NOT -- WHAT YOU CALL THE EDISON DEVICE, I REALLY HAVE NO KNOWLEDGE OF AN EDISON DEVICE. ALL I WAS -- ALL I SAW WAS THE MINILAB AND THE EFFORTS WERE TO COMMERCIALIZE THE MINILAB. AND I HAVE SEEN IN THE NEWSPAPERS, ET CETERA, THE TERM EDISON. THAT IS NOT SOMETHING THAT I'M FAMILIAR WITH, AND I AM NOT COMFORTABLE TESTIFYING ABOUT IT ONE WAY OR THE OTHER.
MR. SCHENK: AND YOU SPENT YOUR TIME FOCUSSING ON THE FUTURE WHEN YOU WERE ON THE BOARD?
FABRIZIO BONANNI: YES.
MR. SCHENK: YOU KNEW THERANOS HAD A LOT OF CHALLENGES, AND YOU WERE TRYING TO GET THEM THROUGH THAT; IS THAT RIGHT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND YOU SAID YOU WERE NEVER DENIED INFORMATION. IF YOU HAD A QUESTION OR WANTED TO SEE DOCUMENTS, MS. HOLMES, OR SOMEONE ELSE AT THERANOS, NEVER SAID, YOU CAN'T SEE THIS DOCTOR; CORRECT?
FABRIZIO BONANNI: CORRECT.
MR. SCHENK: AND I GUESS WHAT I'M WONDERING IS, ISN'T IT A BIG FACT THAT WAS HIDDEN FROM YOU THAT THEY VOIDED ALL OF THOSE EDISON TESTS? HOW DOESN'T THAT CHANGE YOUR VIEW NOW?
(PAUSE IN PROCEEDINGS.)
FABRIZIO BONANNI: I, I, I DON'T KNOW WHAT TO SAY.
BY MR. SCHENK:
MR. SCHENK: LET'S MOVE ON THEN. YOU ALSO -- HELP ME UNDERSTAND HOW MANY HOURS YOU WORKED. YOUR ROLE ON THE BOARD WAS AS AN ADVISOR; IS THAT RIGHT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND WAS THAT A FULL-TIME JOB?
FABRIZIO BONANNI: NO, NO.
MR. SCHENK: HOW -- DO YOU HAVE AN ESTIMATE? CAN YOU HELP ME SORT OF FIGURE OUT HOW MUCH TIME YOU SPENT AT THERANOS OR WORKING ON THERANOS PROJECTS?
FABRIZIO BONANNI: MAYBE A DAY A WEEK AT ONE POINT.
MR. SCHENK: EIGHT HOURS PER WEEK, SO ROUGHLY -- I DON'T KNOW, CAN YOU HELP ME FIGURE OUT WHAT YOU WOULD HAVE DONE A MONTH? WHAT IS THAT, FOUR DAYS A MONTH?
FABRIZIO BONANNI: MAYBE THREE OR FOUR DAYS A MONTH, YES.
MR. SCHENK: AND AS A RESULT, IT ONLY TOOK YOU, WHAT, ABOUT FOUR MONTHS TO FIGURE OUT THAT EVEN CURRENT DATA AT THERANOS, NOT 2013, 2010 TIME, BUT THE TIME YOU WERE THERE, 2016 DATA, YOU DISCOVERED THAT THERE WERE PROBLEMS WITH THAT DATA ALSO, CORRECT, JUST WORKING ONE DAY A WEEK? DO YOU REMEMBER THAT?
FABRIZIO BONANNI: YES.
MR. SCHENK: AND YOU WARNED MS. HOLMES ABOUT THAT; RIGHT?
FABRIZIO BONANNI: NO, NO. YOU'RE REFERRING TO THE DATA THAT WAS GENERATED BY THE CLINICAL LABS.
MR. SCHENK: I'M REFERRING TO DATA WITH REGARD TO ZIKA.
FABRIZIO BONANNI: I DID NOT HAVE TO DISCOVER ANYTHING ABOUT THE DATA ON THE ZIKA. THE COMPANY ITSELF WAS TRYING TO DEVELOP A ZIKA ASSAY, AND OF THE FOUR ELEMENTS OF THE TECHNOLOGY, THREE WERE DEVELOPED FULLY AND IN A FALLIBLE VERSION. THE CASSETTE, THE CARTRIDGE, AND THE REAGENTS HAD DIFFICULTIES ACHIEVING THE RIGHT STATISTICS FOR THE THING AND THEY KEPT BEING DEVELOPED. I DIDN'T HAVE TO POINT THAT OUT. THAT WAS COMING OUT THROUGH THE COMPANY.
MR. SCHENK: YOU RAISED SOME CONCERNS ABOUT THERANOS'S ABILITY TO GENERATE DATA THAT THE FDA WOULD ACCEPT; RIGHT? DO YOU REMEMBER DOING THAT?
FABRIZIO BONANNI: YES, IN THE CONTEXT OF STRENGTHENING THE QUALITY MANAGEMENT SYSTEM THAT WAS NECESSARY, YES.
MR. SCHENK: AND YOU ADVISED MS. HOLMES OF THAT FACT?
FABRIZIO BONANNI: YES.
MR. SCHENK: SO WHEN YOU TESTIFIED THAT YOU WERE FORWARD LOOKING, THE CONCERNS THAT SORT OF PREDATED YOUR ARRIVAL WERE NOT SOMETHING THAT YOU CONCERNED YOURSELF AS MUCH WITH, YOU DIDN'T HAVE TO, THERE WERE ALREADY NEW CONCERNS THAT YOU HAD TO CONCERN YOURSELF WITH; CORRECT? THAT EVEN NEW PROJECTS WITH THIS NEW SCIENTIFIC ADVISORY BOARD, WITH NEW EMPLOYEES, THERE WERE STILL CHALLENGES WITH THE ZIKA DATA?
FABRIZIO BONANNI: YES.
MR. SCHENK: FROM WHAT YOU LEARNED BEGINNING IN 2016 WHEN YOU JOINED THE THERANOS BOARD, WOULD YOU HAVE TOLD ANY INVESTORS, ANY PEOPLE INTERESTED IN GIVING MONEY TO THERANOS, THAT THERANOS WAS PRESENTLY CAPABLE OF TESTING ABOUT 200 ASSAYS ON A THERANOS DEVICE? WOULD YOU HAVE MADE THAT STATEMENT?
FABRIZIO BONANNI: I WOULD NOT HAVE MADE THAT STATEMENT.
MR. SCHENK: BECAUSE IT WOULD NOT HAVE BEEN ACCURATE EVEN IN 2016; CORRECT?
FABRIZIO BONANNI: CORRECT.
MR. SCHENK: AND IN 2016, YOU WOULD NOT HAVE MADE A STATEMENT ABOUT A DEVICE BEING DEPLOYED TO THE BATTLEFIELD IN AFGHANISTAN? YOU NEVER WOULD HAVE MADE THAT STATEMENT?
MR. SCHENK: MS. HOLMES HAD -- WERE YOU AWARE MS. HOLMES HAD MEETINGS WITH VARIOUS INVESTORS BEFORE YOU ARRIVED? I'M TALKING ABOUT IN THE 2010 THROUGH 2013 OR '14 TIMEFRAME.
FABRIZIO BONANNI: YES.
MR. SCHENK: YOU'RE AWARE THAT THAT HAPPENED; CORRECT?
FABRIZIO BONANNI: YES.
MR. SCHENK: BUT YOU DON'T KNOW WHAT WAS SAID DURING THOSE MEETINGS?
MR. SCHENK: YOU DON'T KNOW WHAT SHE SAID TO GET ALAN EISENMAN TO INVEST $100,000; CORRECT?
FABRIZIO BONANNI: I DON'T.
MR. SCHENK: AND YOU DON'T KNOW WHAT SHE SAID TO GET CHRIS LUCAS TO INVEST ABOUT $5.3 MILLION?
MR. SCHENK: YOU DON'T KNOW WHAT SHE SAID TO GET CRAIG HALL OR BRYAN TOLBERT TO INVEST ABOUT $4.8 MILLION?
FABRIZIO BONANNI: I DON'T.
MR. SCHENK: YOU DON'T KNOW WHAT MS. HOLMES SAID TO GET AN INVESTMENT FIRM NAMED PFM TO INVEST ABOUT $38 MILLION; CORRECT?
MR. SCHENK: YOU DON'T KNOW WHAT SHE SAID TO GET RDV TO INVEST ABOUT A HUNDRED MILLION DOLLARS?
MR. SCHENK: YOU DON'T KNOW WHAT SHE SAID TO GET DAN MOSLEY TO INVEST ABOUT $6 MILLION; CORRECT?
MR. SCHENK: THANK YOU. NO FURTHER QUESTIONS.
MS. TREFZ: JUST VERY BRIEFLY, YOUR HONOR.
REDIRECT EXAMINATION BY MS. TREFZ:
MS. TREFZ: DR. BONANNI, JUST ON THE TOPIC OF VOIDED TESTS, I WANT TO MAKE SURE THE RECORD IS CLEAR. THE DECISION TO VOID THERANOS TESTS WAS MADE BEFORE YOU ARRIVED AT THERANOS; CORRECT?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND DID YOU UNDERSTAND THAT WAS A DECISION MADE BY DR. DAS?
FABRIZIO BONANNI: YES.
MS. TREFZ: AND DID YOU -- WHY DID YOU DEFER TO DR. DAS ON THE REASONS FOR THAT DECISION?
FABRIZIO BONANNI: IT'S THE RESPONSIBILITY OF THE MEDICAL DIRECTOR OF A CLINICAL LAB TO VOID ASSAYS. HE HAS THE AUTHORITY TO DO THAT. IT WOULD CERTAINLY BE INAPPROPRIATE FOR A BOARD MEMBER OF ALL THINGS TO HAVE SOMETHING TO SAY ABOUT THAT.
MS. TREFZ: DID MS. HOLMES EVER TELL YOU THAT RESULTS WERE NOT VOIDED AT THERANOS?
MR. SCHENK: OBJECTION. CALLS FOR HEARSAY.
JUDGE DAVILA: SUSTAINED.
BY MS. TREFZ:
MS. TREFZ: DID YOU EVER INVESTIGATE THE REASONS FOR THE TESTS BEING VOIDED BEFORE YOU GOT THERE?
FABRIZIO BONANNI: I DID NOT.
MS. TREFZ: JUST ONE MOMENT, YOUR HONOR.
JUDGE DAVILA: YES.
(DISCUSSION AMONGST DEFENSE COUNSEL OFF THE RECORD.)
BY MS. TREFZ:
MS. TREFZ: DID YOU SPEAK WITH DAS REGARDING THE VOIDING OF THE TESTS?
MS. TREFZ: DID YOU EVER DO AN EXAMINATION OF THE EDISON DEVICE?
MS. TREFZ: DID YOU EVER RE-REVIEW THE RESULTS THAT -- AND DATA THAT DR. DAS HAD LOOKED AT?
MS. TREFZ: DID ANYONE EVER ASK YOU TO DO THAT?
MS. TREFZ: NO FURTHER QUESTIONS, YOUR HONOR.
JUDGE DAVILA: MR. SCHENK?
MR. SCHENK: NOTHING FURTHER.
JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?
MR. SCHENK: YES, YOUR HONOR.
MS. TREFZ: YES, YOUR HONOR.
JUDGE DAVILA: YOU'RE EXCUSED, SIR.
FABRIZIO BONANNI: THANK YOU.
JUDGE DAVILA: MR. DOWNEY?
MR. DOWNEY: YES, SIR. THE DEFENSE CALLS ELIZABETH HOLMES.
JUDGE DAVILA: MS. HOLMES, IF YOU WOULD WALK OVER HERE AND GIVE MS. KRATZMANN JUST A MOMENT. IF YOU WOULD RAISE YOUR RIGHT HAND WHILE YOU FACE HER, SHE HAS A QUESTION.
(DEFENDANT'S WITNESS, ELIZABETH HOLMES, WAS SWORN.)
FABRIZIO BONANNI: YES.
COURT CLERK: THANK YOU.
JUDGE DAVILA: I'LL INVITE YOU TO HAVE A SEAT HERE. MAKE YOURSELF COMFORTABLE.
FABRIZIO BONANNI: YES, THANK YOU.
JUDGE DAVILA: YOU'RE WELCOME. FEEL FREE TO ADJUST THE CHAIR AND THE MICROPHONE AS YOU NEED. THERE'S REFRESHMENTS THERE AS I THINK YOU'RE AWARE. FEEL FREE TO HELP YOURSELF.
FABRIZIO BONANNI: OKAY. THANK YOU.
JUDGE DAVILA: WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME AND THEN SPELL IT, PLEASE.
FABRIZIO BONANNI: YES. MY NAME IS ELIZABETH HOLMES. E-L-I-Z-A-B-E-T-H, H-O-L-M-E-S.
JUDGE DAVILA: THANK YOU.
MR. DOWNEY: YOUR HONOR, MAY I APPROACH?
JUDGE DAVILA: YES.