Kingshuk Das — Direct/Cross
1,203 linesDIRECT EXAMINATION BY MR. LEACH:
MR. LEACH: GOOD AFTERNOON, DR. DAS. IN OR ABOUT DECEMBER OF 2015, WERE YOU ENGAGED TO SERVE AS THE LABORATORY DIRECTOR OF THERANOS'S CALIFORNIA CLINICAL LABORATORY?
KINGSHUK DAS: YES, I WAS.
MR. LEACH: OKAY. HOW LONG DID YOU SERVE IN THAT ROLE?
KINGSHUK DAS: APPROXIMATELY TWO AND A HALF YEARS.
MR. LEACH: OKAY. LET'S TALK A LITTLE BIT ABOUT YOUR EDUCATIONAL AND PROFESSIONAL BACKGROUND. DO YOU HAVE A COLLEGE DEGREE?
KINGSHUK DAS: I DO.
MR. LEACH: WHERE DID YOU GET YOUR COLLEGE DEGREE FROM?
KINGSHUK DAS: AT CASE WESTERN RESERVE UNIVERSITY.
MR. LEACH: AND WHAT WAS YOUR DEGREE IN?
KINGSHUK DAS: IT WAS A BACHELOR OF ARTS IN BIOCHEMISTRY.
MR. LEACH: AND WHEN DID YOU OBTAIN YOUR BACHELOR OF ARTS IN BIOCHEMISTRY FROM CASE WESTERN?
KINGSHUK DAS: THAT WOULD HAVE BEEN 1996.
MR. LEACH: AND DO YOU HAVE A MEDICAL DEGREE?
KINGSHUK DAS: I DO.
MR. LEACH: AND IS THAT ALSO FROM CASE WESTERN RESERVE UNIVERSITY?
KINGSHUK DAS: YES.
MR. LEACH: AND WHEN DID YOU GET YOUR MEDICAL DEGREE?
KINGSHUK DAS: THAT WOULD HAVE BEEN 2002.
MR. LEACH: OKAY. AFTER OBTAINING YOUR MEDICAL DEGREE, DID YOU DO AN INTERNSHIP?
KINGSHUK DAS: I DID.
MR. LEACH: AND WHAT WAS YOUR INTERNSHIP IN?
KINGSHUK DAS: INTERNAL MEDICINE.
MR. LEACH: AND WHERE DID YOU PERFORM YOUR INTERNSHIP?
KINGSHUK DAS: THAT WAS AT THE UCLA WEST LOS ANGELES MEDICAL CENTER.
MR. LEACH: IS THAT IN WESTWOOD?
KINGSHUK DAS: YES, IT IS.
MR. LEACH: OKAY. AND DID YOU PERFORM A RESIDENCY?
KINGSHUK DAS: I DID.
MR. LEACH: AND WHAT WAS YOUR RESIDENCY IN?
KINGSHUK DAS: IN CLINICAL PATHOLOGY.
MR. LEACH: WHAT IS CLINICAL PATHOLOGY?
KINGSHUK DAS: THAT IS A DISCIPLINE OF PATHOLOGY THAT SPECIALIZES IN LABORATORY MEDICINE.
MR. LEACH: AFTER -- AND WHERE DID YOU PERFORM YOUR RESIDENCY?
KINGSHUK DAS: IT WAS BETWEEN TWO SITES. FIRST AT WASHINGTON UNIVERSITY IN ST. LOUIS, FOLLOWED BY THE UNIVERSITY OF SOUTHERN CALIFORNIA.
MR. LEACH: SO YOU WENT FROM UCLA TO U.S.C.?
KINGSHUK DAS: THAT IS CORRECT, SIR.
MR. LEACH: OKAY. AND DID YOU GO BACK TO UCLA AT SOME POINT AFTER YOUR RESIDENCY?
KINGSHUK DAS: I DID.
MR. LEACH: TELL US ABOUT THAT, PLEASE.
KINGSHUK DAS: I PURSUED A FELLOWSHIP IN MOLECULAR GENETICS AT UCLA.
MR. LEACH: AND DID YOU ALSO SERVE ON THE FACULTY AT UCLA?
KINGSHUK DAS: I DID AFTERWARD.
MR. LEACH: AND WHAT POSITIONS ON THE FACULTY DID YOU HOLD?
KINGSHUK DAS: I STARTED OFF AS AN ASSOCIATE MEDICAL DIRECTOR FOR THEIR MOLECULAR PATHOLOGY DEPARTMENT, AND THAT WAS FOLLOWED BY A ROLE AS DIRECTOR OF OPERATIONS OF GENETIC MEDICINE, AFTER WHICH I WAS ASSOCIATE MEDICAL DIRECTOR OF CLINICAL LABORATORIES.
MR. LEACH: OKAY. AND HAVE YOU SERVED IN SOMETHING CALLED UCLA CLINICAL LABORATORIES?
KINGSHUK DAS: YES.
MR. LEACH: AND WHAT IS THAT?
KINGSHUK DAS: THAT IS THE ACADEMIC MEDICAL CENTER LABORATORY AT UCLA.
MR. LEACH: AND DID YOU HOLD A POSITION EQUIVALENT TO A LABORATORY DIRECTOR IN THAT INSTITUTION?
KINGSHUK DAS: CORRECT.
MR. LEACH: ARE YOU LICENSED TO PRACTICE MEDICINE?
KINGSHUK DAS: YES, I AM.
MR. LEACH: IN WHAT STATES?
KINGSHUK DAS: IN THE STATES OF CALIFORNIA AND MINNESOTA.
MR. LEACH: AND DO YOU HOLD ANY BOARD CERTIFICATIONS?
KINGSHUK DAS: I DO.
MR. LEACH: IN WHAT?
KINGSHUK DAS: IN CLINICAL PATHOLOGY.
MR. LEACH: I WANT TO DRAW YOUR ATTENTION TO THE TIME PERIOD DECEMBER OF 2015. IN OR ABOUT THAT TIME PERIOD, DID YOU LEARN OF A COMPANY CALLED THERANOS?
KINGSHUK DAS: I DID.
MR. LEACH: OKAY. HOW DID THERANOS COME TO YOUR ATTENTION?
KINGSHUK DAS: I RESPONDED TO A JOB POSTING ON THE THERANOS WEBSITE.
MR. LEACH: AND WHAT WAS THE JOB POSTING FOR?
KINGSHUK DAS: IT WAS FOR A LABORATORY DIRECTOR OF THEIR NEWARK, CALIFORNIA LAB.
MR. LEACH: AND DID YOU INTERVIEW FOR THAT POSITION?
KINGSHUK DAS: I DID.
MR. LEACH: AND DID YOU INTERVIEW WITH MS. HOLMES?
KINGSHUK DAS: I DID.
MR. LEACH: AND DID YOU ULTIMATELY GET THE JOB?
KINGSHUK DAS: I DID.
MR. LEACH: WHEN YOU WERE HIRED, WERE YOU ABLE TO START RIGHT AWAY IN DECEMBER OF 2015?
KINGSHUK DAS: NOT RIGHT AWAY.
MR. LEACH: OKAY. WHY WAS THAT?
KINGSHUK DAS: I HAD ADDITIONAL RESPONSIBILITIES AT UCLA THAT NEEDED ATTENDING TO.
MR. LEACH: OKAY. AND WHEN WERE YOU ABLE TO START FULL TIME AS THE LABORATORY DIRECTOR AT THERANOS?
KINGSHUK DAS: FULL TIME WOULD HAVE BEEN -- I FORGET THE EXACT DATE, BUT IT WOULD HAVE BEEN A MONDAY IN MID-MARCH 2016.
MR. LEACH: OKAY. AND IN BETWEEN MID-MARCH AND DECEMBER, DID YOU SERVE IN A CONTRACTING ROLE FOR THERANOS AS YOU WRAPPED UP THINGS AT UCLA?
KINGSHUK DAS: I DID.
MR. LEACH: OKAY. I WANT TO TALK A LITTLE BIT ABOUT THE ROLE OF LABORATORY DIRECTOR. YOU HAD SERVED IN THAT CAPACITY BEFORE YOUR TIME AT THERANOS; IS THAT CORRECT?
KINGSHUK DAS: CORRECT.
MR. LEACH: OKAY. AND IN THE COURSE OF SERVING AS A LAB DIRECTOR, DID YOU BECOME FAMILIAR WITH SOMETHING CALLED CMS?
KINGSHUK DAS: YES.
MR. LEACH: AND WHAT IS CMS?
KINGSHUK DAS: IT IS THE CENTER FOR MEDICARE AND MEDICAID SERVICES.
MR. LEACH: OKAY. AND HOW IS CMS RELEVANT TO YOUR JOB AS A LABORATORY DIRECTOR?
KINGSHUK DAS: THEY ADMINISTER THE CLIA AMENDMENTS AND, THEREFORE, OVERSEE CLINICAL LABORATORIES IN THE UNITED STATES.
MR. LEACH: OKAY. CLIA IS AN ACRONYM?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND TO YOUR KNOWLEDGE, DOES CMS CONDUCT ON-SITE SURVEYS TO DETERMINE WHETHER ANY GIVEN LABORATORY IS MEETING THE CONDITIONS AND STANDARDS SET FORTH IN THE FEDERAL REGULATIONS?
KINGSHUK DAS: THAT IS MY UNDERSTANDING.
MR. LEACH: OKAY. AND HAVE YOU PARTICIPATED IN SURVEYS LIKE THAT BEFORE?
KINGSHUK DAS: I HAVE NOT.
MR. LEACH: OKAY. PRIOR TO YOUR TIME AT THERANOS, HAVE YOU PARTICIPATED IN A SURVEY SUCH AS THAT?
KINGSHUK DAS: NO.
MR. LEACH: OKAY. DO CLIA REGULATIONS PLACE CERTAIN RESPONSIBILITIES ON YOU WHEN SERVING AS A LABORATORY DIRECTOR?
KINGSHUK DAS: YES, THAT'S CORRECT.
MR. LEACH: OKAY. DO THE CLIA REGULATIONS ALSO PROVIDE POSSIBLE CONSEQUENCES FOR THE OWNERS AND OPERATORS OF LABORATORIES?
KINGSHUK DAS: THAT IS MY UNDERSTANDING.
MR. LEACH: OKAY. DR. DAS, WE ARE HAVING SOME TECHNOLOGY ISSUES IN THE COURTROOM TODAY, AND SO FOR THE DISPLAY OF DOCUMENTS, WE'RE GOING TO BE DISPLAYING THEM UP ON THE WALL AND DIMMING THE LIGHTS, AND THAT'S WHY WE HAVE A LIGHT NEAR YOU. SO FOR CERTAIN DOCUMENTS, YOU SHOULD HAVE A COPY RIGHT IN FRONT OF YOU IN YOUR BINDER, AND FOR OTHER ONES THAT ARE IN EVIDENCE, WE MAY JUST BE DISPLAYING THEM. BUT AT ANY POINT IF YOU NEED ASSISTANCE OR CAN'T SEE SOMETHING OR NEEDS GLASSES, JUST LET ME KNOW. BUT I WANTED TO DRAW YOUR ATTENTION TO WHAT IS IN EVIDENCE AS DOCUMENT 7603. PERMISSION TO DISPLAY, YOUR HONOR?
JUDGE DAVILA: YES. THAT'S NOT IN THE BINDER -- IT IS IN THE BINDER?
MR. LEACH: YES.
KINGSHUK DAS: IT IS HERE.
BY MR. LEACH:
MR. LEACH: DR. DAS, IF I COULD PLEASE DRAW YOUR ATTENTION TO PAGE 118 OF EXHIBIT 7603. AND, MS. HOLLIMAN, IF WE COULD PLEASE HIGHLIGHT THE TOP PORTION OF THE RIGHT COLUMN UNDERNEATH THE BOLD HEADING, THE FIRST TWO PARAGRAPHS BENEATH THAT HEADING. DR. DAS, I'M DRAWING YOUR ATTENTION TO PAGE 118 OF THE TRIAL EXHIBIT. DO YOU HAVE THAT IN FRONT OF YOU?
KINGSHUK DAS: I DO NOW.
MR. LEACH: OKAY. ARE YOU ABLE TO SEE IT OKAY WITH THE LIGHT THERE?
KINGSHUK DAS: YES, I CAN SEE IT JUST FINE.
MR. LEACH: OKAY. DO YOU SEE THE SECTION HEADING 493.1840, "SUSPENSION, LIMITATION, OR REVOCATION OF ANY TYPE OF CLIA CERTIFICATE"? DO YOU SEE THAT HEADING?
KINGSHUK DAS: I DO.
JUDGE DAVILA: WE DISCUSSED THIS. OVERRULED. THIS IS IN EVIDENCE. IT CAN BE EXAMINED.
BY MR. LEACH:
MR. LEACH: IS THIS ONE OF THE CLIA REGULATIONS, DR. DAS, THAT AFFECTS LABORATORY DIRECTORS?
KINGSHUK DAS: YES, I BELIEVE SO.
MR. LEACH: IN PARAGRAPH A IT SAYS, "ADVERSE ACTION BASED ON ACTIONS OF THE LABORATORY'S OWNER, OPERATOR, OR EMPLOYEES." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: I DO.
MR. LEACH: AND DO YOU SEE WHERE IT SAYS, "CMS MAY INITIATE ADVERSE ACTION TO SUSPEND, LIMIT, OR REVOKE ANY CLIA CERTIFICATE IF CMS FINDS THAT A LABORATORY'S OWNER OR OPERATOR OR ONE OF ITS EMPLOYEES HAS --" DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: I DO.
MR. LEACH: AND THEN IS THERE A LIST OF CERTAIN CONDUCT THAT -- FOLLOWING PARAGRAPH A IN THAT SUBSECTION?
KINGSHUK DAS: YES, THERE IS.
MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION DOWN TO THE BOTTOM PORTION OF THIS COLUMN. AND IF WE CAN HIGHLIGHT PARAGRAPH 4 ALL OF THE WAY DOWN, MS. HOLLIMAN. DO YOU SEE WHERE IT SAYS IN PARAGRAPH 6, "VIOLATED OR AIDED AND ABETTED IN THE VIOLATION OF ANY PROVISIONS OF CLIA AND ITS IMPLEMENTING REGULATIONS"?
KINGSHUK DAS: I DO.
MR. LEACH: AND IS THAT ONE OF THE CONDITIONS WHERE CMS MAY INITIATE ACTION TO SUSPEND, LIMIT, OR REVOKE ANY CLIA CERTIFICATE IF IT MAKES THAT FINDING?
JUDGE DAVILA: OVERRULED.
KINGSHUK DAS: YES, I BELIEVE SO.
BY MR. LEACH:
MR. LEACH: AND FURTHER DOWN BELOW IN PARAGRAPH 8, DO YOU SEE WHERE IT SAYS, "WITHIN THE PRECEDING TWO-YEAR PERIOD, OWNED OR OPERATED A LABORATORY THAT HAD ITS CLIA CERTIFICATE REVOKED." DO YOU SEE THAT?
KINGSHUK DAS: I DO SEE THAT.
MR. LEACH: IS THAT ONE OF THE PROVISIONS RELATING TO OWNERS AND OPERATORS OF LABORATORIES?
KINGSHUK DAS: YES, I BELIEVE SO.
MR. LEACH: IF I COULD DRAW YOUR ATTENTION NOW TO PAGE 8 -- EXCUSE ME, PAGE 7 OF THE EXHIBIT WHICH IS IN EVIDENCE. MS. HOLLIMAN, IF WE COULD PLEASE HIGHLIGHT THE COLUMN ON THE FAR RIGHT STARTING WITH THE ITALICIZED WORD "OPERATOR." DOWN A LITTLE MORE, PLEASE. A LITTLE MORE. THAT WILL DO. DR. DAS, WE'RE ON PAGE 7 OF EXHIBIT 4603, THE CLIA REGULATIONS. DO YOU SEE SOME DEFINITIONS LISTED OUT ON THIS PAGE?
KINGSHUK DAS: I DO.
MR. LEACH: AND DO YOU SEE A DEFINITION FOR "OPERATOR"?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND DOES THIS READ, "OPERATOR MEANS THE INDIVIDUAL OR GROUP OF INDIVIDUALS WHO OVERSEE ALL FACETS OF THE OPERATION OF A LABORATORY AND WHO BEAR PRIMARY RESPONSIBILITY FOR THE SAFETY AND RELIABILITY OF THE RESULTS OF ALL SPECIMEN TESTING PERFORMED IN THAT LABORATORY"? DID I READ THAT DEFINITION CORRECTLY?
KINGSHUK DAS: YES.
MR. LEACH: AND FURTHER DOWN BELOW, IS THERE A DEFINITION FOR THE "OWNER" OF A LABORATORY?
KINGSHUK DAS: YES.
MR. LEACH: AND WAS THIS PART OF THE REGULATIONS THAT YOU UNDERSTOOD YOU WERE SUBJECT TO IN YOUR ROLE OF THE -- AS THE LABORATORY DIRECTOR?
KINGSHUK DAS: YES, THAT'S CORRECT.
MR. LEACH: OKAY. LET ME FOCUS -- WE CAN TAKE THAT DOWN, MS. HOLLIMAN. THANK YOU. LET ME FOCUS ON WHAT YOU DID UPON YOUR ARRIVAL AT THE COMPANY. IF WE CAN BREAK IT INTO THE TIME PERIOD WHEN YOU WERE INITIALLY WORKING PART-TIME COMING UP FROM UCLA, DESCRIBE FOR US WHAT YOU DID TO ORIENT YOURSELF WITH THE LABORATORY.
KINGSHUK DAS: I WAS COMING UP FOR ABOUT ONE DAY PER WEEK UNTIL I JOINED FULL TIME, AND MOST OF THAT TIME WAS SPENT GETTING TO KNOW THE PHYSICAL SPACE, THE LABORATORY, THE EMPLOYEES, THE CONSULTANTS, AS WELL AS DEALING WITH SOME PAPERWORK FROM CMS.
MR. LEACH: WHEN YOU STARTED IN THE -- AND THIS IS LEADING UP TO YOUR TIME PERIOD IN MARCH?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: AND HOW REGULARLY WERE YOU COMING UP?
KINGSHUK DAS: ONCE PER WEEK.
MR. LEACH: OKAY.
KINGSHUK DAS: ONE DAY PER WEEK.
MR. LEACH: AS YOU WERE GETTING ORIENTED WITH THE LAB, DID YOU DEVELOP A FAMILIARITY WITH WHAT TYPE OF TESTS THERANOS WAS CURRENTLY PERFORMING AND HAD BEEN PERFORMING IN ITS LABORATORY?
KINGSHUK DAS: YES, I DID.
MR. LEACH: OKAY. AT THE TIME THAT YOU STARTED, WAS THERANOS PERFORMING ANY LAB DEVELOPED TESTS?
KINGSHUK DAS: NOT TO MY KNOWLEDGE.
MR. LEACH: OKAY. AND ARE YOU FAMILIAR WITH THE ACRONYM LDT?
KINGSHUK DAS: YES, I AM.
MR. LEACH: AND IS THAT FOR LABORATORY DEVELOPED TESTS?
KINGSHUK DAS: CORRECT.
MR. LEACH: AND WHAT DOES THAT MEAN?
KINGSHUK DAS: IT MEANS ANY TEST THAT IS EITHER DEVELOPED BY THE LABORATORY OR AN FDA APPROVED METHOD THAT IS MODIFIED GENERALLY.
MR. LEACH: SO IF YOU TAKE AN FDA APPROVED METHOD AND MAKE SOME TYPE OF TWEAK TO IT, THAT CONVERTS IT TO A LAB DEVELOPED TEST?
KINGSHUK DAS: IT'S ANALOGOUS TO A LAB DEVELOPED TEST, YES.
MR. LEACH: AND AT THE TIME THAT YOU STARTED IN THE LAB, WAS THERANOS PERFORMING ANY TESTS ON THERANOS MANUFACTURED ANALYZERS?
KINGSHUK DAS: NOT TO MY KNOWLEDGE.
MR. LEACH: TO YOUR KNOWLEDGE, WAS IT PERFORMING ANY TESTS ON SOMETHING CALLED EDISON?
KINGSHUK DAS: NOT TO MY KNOWLEDGE.
MR. LEACH: WAS IT PERFORMING ANY TESTS ON SOMETHING CALLED THE MINILAB?
KINGSHUK DAS: NOT TO MY KNOWLEDGE.
MR. LEACH: HOW ABOUT SOMETHING CALLED THE TSPU?
KINGSHUK DAS: AGAIN, NOT TO MY KNOWLEDGE.
MR. LEACH: AND TO YOUR KNOWLEDGE, WAS IT PERFORMING ANY TESTS ON FINGERSTICK SAMPLES ON NON-FDA APPROVED MACHINES?
KINGSHUK DAS: NO, NOT TO MY KNOWLEDGE.
MR. LEACH: I'D LIKE TO DISPLAY FOR YOU WHAT IS -- WITHDRAWN. WHEN YOU JOINED THE LAB IN SEPTEMBER OF 2015, IN THE INTERIM PERIOD, DID YOU DEVELOP A SENSE OF THE ANNUAL VOLUME OF TESTS THAT WERE PERFORMED IN THE CALIFORNIA LAB BEFORE YOU JOINED?
KINGSHUK DAS: I BELIEVE THERE WAS AN ESTIMATE IN SOME OF THE FEDERAL PAPERWORK.
MR. LEACH: AND WHAT WAS THAT ESTIMATE?
KINGSHUK DAS: I BELIEVE IT WAS SOMEWHERE BETWEEN 800- AND 900,000 TESTS.
MR. LEACH: AND WAS THAT ON AN ANNUAL BASIS?
KINGSHUK DAS: I BELIEVE SO.
MR. LEACH: AND AS YOU ARE BECOMING FAMILIAR WITH THERANOS AND THE LABORATORY AS THE LABORATORY DIRECTOR IN CALIFORNIA, DID YOU ALSO DEVELOP AN AWARENESS THAT THERANOS HAD A LAB IN ARIZONA?
KINGSHUK DAS: I WAS AWARE OF THAT.
MR. LEACH: AND WHAT WAS YOUR UNDERSTANDING? WHAT DID YOU UNDERSTAND ABOUT THAT LAB?
KINGSHUK DAS: MY UNDERSTANDING WAS THAT THAT LABORATORY IN SCOTTSDALE WAS A MODERATE COMPLEXITY LABORATORY.
MR. LEACH: AND WHAT DOES THAT MEAN TO BE A MODERATE COMPLEXITY LABORATORY?
KINGSHUK DAS: IN THIS CONTEXT IT MEANS THAT THAT TYPE OF LABORATORY RUNS FDA APPROVED TESTING.
MR. LEACH: SO WOULD THAT LABORATORY BE RUNNING AN EDISON?
KINGSHUK DAS: I DON'T BELIEVE SO.
MR. LEACH: WOULD THAT LABORATORY BE RUNNING A FINGERSTICK TEST ON A MODIFIED FDA APPROVED MACHINE?
KINGSHUK DAS: NO, I DON'T BELIEVE SO.
MR. LEACH: AND HOW DID THE MODERATE COMPLEXITY IN THE ARIZONA LAB COMPARE TO THE CALIFORNIA LAB THAT YOU TOOK THE REINS OF IN THE LATE 2015, EARLY 2016 TIME PERIOD?
KINGSHUK DAS: THE NEWARK, CALIFORNIA LABORATORY WAS CONSIDERED HIGH COMPLEXITY AND COULD OFFER SUCH TESTING.
MR. LEACH: SUCH AS LDT'S?
KINGSHUK DAS: SUCH AS LDT'S, YES.
MR. LEACH: AND AS YOU'RE BECOMING THE LABORATORY DIRECTOR, DID YOU DEVELOP A SENSE OF THE RELATIVE VOLUME OF TESTING BETWEEN THE MODERATE COMPLEXITY LAB IN ARIZONA AND THE HIGH COMPLEXITY LAB IN CALIFORNIA?
KINGSHUK DAS: I DID NOT HAVE A GOOD SENSE OF THE PROPORTION OF TESTING DONE IN BOTH LABS.
MR. LEACH: AT SOME POINT DID YOU DEVELOP THAT UNDERSTANDING?
KINGSHUK DAS: I DID NOT.
MR. LEACH: OKAY. DID YOU HAVE ANY INTERACTIONS WITH SUNNY BALWANI?
KINGSHUK DAS: YES, TO SOME EXTENT.
MR. LEACH: OKAY. A LOT OF INTERACTIONS? A FEW INTERACTIONS? DESCRIBE THOSE FOR US.
KINGSHUK DAS: QUITE MINIMUM NUMBER OF INTERACTIONS. I BELIEVE SUNNY LEFT THE COMPANY NOT TOO LONG AFTER I JOINED.
MR. LEACH: SO SOMETIME IN THE MARCH 2016 TIME PERIOD?
KINGSHUK DAS: YEAH. I'M NOT CLEAR ON THE EXACT DATES, BUT WE HAD VERY LIMITED CHANCES TO INTERACT.
MR. LEACH: LET'S MOVE FORWARD IN TIME TO THE TIME PERIOD OF MARCH OF 2016. THAT'S WHEN YOU BEGAN WORKING ON A FULL-TIME BASIS IN THE LAB?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: AND YOU LEFT YOUR RESPONSIBILITIES IN UCLA?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU MOVE UP TO CALIFORNIA TO WORK IN THE LAB HERE -- MOVE UP TO THE BAY AREA TO WORK IN THE LAB?
KINGSHUK DAS: I DID.
MR. LEACH: OKAY. AND YOU MENTIONED EARLIER PART OF YOUR RESPONSIBILITIES INITIALLY WAS DEALING WITH PAPERWORK FROM CMS. WHAT WERE YOU TALKING ABOUT?
KINGSHUK DAS: IT WAS RELATED TO AN AUDIT, I BELIEVE, THAT WOULD HAVE BEEN BEFORE I JOINED, AND A STATEMENT OF DEFICIENCIES FROM THAT AUDIT.
MR. LEACH: AND WAS A SIGNIFICANT PART OF YOUR JOB AS THE LAB DIRECTOR REVIEWING THAT STATEMENT, DEVELOPING AN UNDERSTANDING OF IT, AND RESPONDING TO IT?
KINGSHUK DAS: YES. THAT WAS NEARLY THE SOLE RESPONSIBILITY THAT I HAD.
MR. LEACH: OKAY. IN THIS EARLY MARCH 2016 TIME PERIOD, WHAT TYPES OF DOCUMENTS DID YOU REVIEW AND GATHER IN CONNECTION WITH, WITH RESPONDING TO THIS STATEMENT OF DEFICIENCIES?
KINGSHUK DAS: OH, THERE WERE A VARIETY OF DOCUMENTS. DO YOU NEED SPECIFIC EXAMPLES, OR ARE YOU REFERRING TO SPECIFIC EXAMPLES?
MR. LEACH: IF YOU COULD PUT THEM INTO BUCKETS FOR US, THAT WOULD BE GREAT.
KINGSHUK DAS: I WOULD SAY THE MAJORITY OF MY RESPONSIBILITY IN RESPONDING TO THAT FORM, THAT STATEMENT OF DEFICIENCIES, WAS TO PERFORM WHAT ARE CALLED PATIENT IMPACT ASSESSMENTS. I BELIEVE THE DOCUMENTATION WAS GENERALLY SPLIT INTO ABOUT THREE BUCKETS.
MR. LEACH: OKAY. WHAT ARE THOSE?
KINGSHUK DAS: THE FIRST ONE WAS VALIDATION REPORTS FOR THE TESTS PERFORMED.
MR. LEACH: WHAT WAS THE SECOND?
KINGSHUK DAS: THE SECOND ONE WAS GENERALLY QUALITY CONTROL RESULTS AND REPORTS.
MR. LEACH: AND THE THIRD?
KINGSHUK DAS: THE THIRD WAS PATIENT TEST RESULT DISTRIBUTIONS AND CALCULATIONS FROM THOSE.
MR. LEACH: AND DID YOU HAVE A TEAM WORKING WITH YOU IN RESPONDING TO THIS REPORT FROM, OR STATEMENT OF DEFICIENCIES FROM CMS?
KINGSHUK DAS: YES, INDEED.
MR. LEACH: OKAY. AND WHO WAS ON YOUR TEAM?
KINGSHUK DAS: OKAY. IT WAS QUITE A LARGE TEAM. I WON'T REMEMBER ALL OF THE NAMES. THE PEOPLE THAT I WORKED MOST CLOSELY WITH I COULD NAME IF THAT'S OF HELP.
MR. LEACH: THAT WOULD BE HELPFUL. THANK YOU.
KINGSHUK DAS: THE DIRECTORS THAT I WORKED WITH VERY CLOSELY WERE DOCTORS TSCHIRHART AND HELFEND.
MR. LEACH: COULD YOU SPELL TSCHIRHART FOR US, PLEASE.
KINGSHUK DAS: YES, I HOPE I CAN. I BELIEVE THAT'S T-S-C-H-I-R-H-A-R-T. FIRST NAME IS DONALD.
MR. LEACH: AND YOU MENTIONED DR. HELFEND.
KINGSHUK DAS: YES, LISA HELFEND.
MR. LEACH: IS THAT H-E-L-F-U-N-D?
KINGSHUK DAS: H-E-L-F-E-N-D.
MR. LEACH: OKAY. DID THEY COME ON AT AROUND THE TIME YOU CAME ON AS LAB DIRECTOR?
KINGSHUK DAS: I BELIEVE DON JOINED THE EXACT SAME DAY I JOINED, AND LISA WAS ALREADY THERE AS A CONTRACT DIRECTOR.
MR. LEACH: LET ME DRAW YOUR ATTENTION, PLEASE, TO WHAT HAS BEEN MARKED FOR IDENTIFICATION AS 4621.
KINGSHUK DAS: YES.
MR. LEACH: DO YOU RECOGNIZE THIS DOCUMENT?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND WHAT IS IT?
KINGSHUK DAS: THIS APPEARS TO BE THE COVER LETTER FOR THE STATEMENT OF DEFICIENCIES.
MR. LEACH: AND DOES THE COVER LETTER COMPRISE PAGES 1 THROUGH 4 OF EXHIBIT 4621?
KINGSHUK DAS: YES.
MR. LEACH: AND DOES THE STATEMENT OF DEFICIENCIES BEGIN ON PAGE 5?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION TO THE BOTTOM OF PAGE 5. DO YOU SEE TO THE LEFT WHERE IT SAYS FORM 6 CMS 2567?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND DO YOU SEE A DATE IN THE UPPER RIGHT-HAND CORNER, JANUARY 25TH, 2016?
KINGSHUK DAS: I DO.
MR. LEACH: AND TO THE LEFT DO YOU SEE A BOX THAT SAYS, FOR THE TITLE OF THE DOCUMENT, STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. IS THIS THE FORM THAT YOU TESTIFIED YOU SPENT A SIGNIFICANT AMOUNT OF YOUR TIME RESPONDING TO IN YOUR ROLE AS THE LAB DIRECTOR?
KINGSHUK DAS: YES, THAT'S CORRECT.
MR. LEACH: OKAY. HOW MANY PAGES IS THE STATEMENT OF DEFICIENCIES?
KINGSHUK DAS: IT LOOKS LIKE IN MY COPY 121.
MR. LEACH: IN YOUR ROLE AS LABORATORY DIRECTOR, WHO DID YOU REPORT TO?
KINGSHUK DAS: I REPORTED TO MS. HOLMES.
MR. LEACH: AND IN THE COURSE OF RESPONDING TO THE FORM 2567, THE STATEMENT OF DEFICIENCIES, DID YOU HAVE CONVERSATIONS WITH MS. HOLMES?
KINGSHUK DAS: YES.
MR. LEACH: MORE THAN ONE?
KINGSHUK DAS: MANY CONVERSATIONS.
MR. LEACH: AND DID THOSE RELATE TO WHAT YOU WERE FIND -- OR WHAT CMS HAD BROUGHT TO THE COMPANY'S ATTENTION, WHAT YOU WERE FINDING AND HOW THE COMPANY WAS GOING TO RESPOND?
KINGSHUK DAS: YES, AMONG OTHERS.
MR. LEACH: OKAY. DID YOU TRAVEL TO WASHINGTON, D.C. WITH MS. HOLMES TO MEET WITH INDIVIDUALS FROM CMS?
KINGSHUK DAS: YES, I DID.
MR. LEACH: AND WAS THAT IN CONNECTION WITH RESPONDING TO THE FORM 2567?
KINGSHUK DAS: YES, IT WAS.
MR. LEACH: WE'RE GOING TO COME BACK TO 4621, BUT I'D LIKE TO BRIEFLY DRAW YOUR ATTENTION TO EXHIBIT 5260.
KINGSHUK DAS: OKAY.
MR. LEACH: AND IF I COULD DRAW YOUR ATTENTION TO PAGE 90, IS THAT YOUR SIGNATURE?
KINGSHUK DAS: YES.
MR. LEACH: AND IF WE CAN GO TO PAGE 2 OF THE EXHIBIT, DO YOU SEE A DATE AT THE TOP OF MARCH 28TH, 2016?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND IS THIS A LETTER THAT YOU SENT TO CMS IN RESPONSE TO A LETTER FROM CMS TO DR. SUNIL DHAWAN, ELIZABETH HOLMES, AND SUNNY BALWANI?
KINGSHUK DAS: YES, I BELIEVE SO.
MR. LEACH: OKAY. AND IS THIS LETTER IN CONNECTION WITH THE COMPANY'S RESPONSE TO THE 2567?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: OKAY. AND DID YOU HAVE MANY CONVERSATIONS WITH MS. HOLMES BOTH ABOUT WHAT CMS BROUGHT TO THE COMPANY'S ATTENTION IN 2567 AND HOW THE COMPANY WAS GOING TO RESPOND?
KINGSHUK DAS: YES, THAT'S CORRECT.
MR. LEACH: PLEASE LOOK BRIEFLY AT EXHIBIT 3144. IS THAT YOUR -- AND I DRAW YOUR ATTENTION TO PAGE 93.
KINGSHUK DAS: YES.
MR. LEACH: IS THAT YOUR SIGNATURE?
KINGSHUK DAS: YES, THAT'S CORRECT.
MR. LEACH: OKAY. AND IF WE CAN GO BACK TO PAGE 1, DOES THIS APPEAR TO BE AN APRIL 1ST, 2016 LETTER FROM YOU TO THERANOS UPDATING A RESPONSE TO A LETTER FROM CMS TO DR. SUNIL DHAWAN, ELIZABETH HOLMES, AND SUNNY BALWANI?
KINGSHUK DAS: YES, THAT'S CORRECT, FROM THERANOS.
MR. LEACH: OKAY. AND WE'VE JUST LOOKED AT SOME LETTERS FROM THE MARCH AND APRIL TIME PERIOD, BUT YOU HAD -- DID YOU HAVE A NUMBER OF CONVERSATIONS WITH MS. HOLMES ABOUT THE 2567 AND WHAT WAS BEING REPORTED TO THE COMPANY?
KINGSHUK DAS: YES, PERIODICALLY.
MR. LEACH: OKAY. LET ME GO -- WAS THERE SOME URGENCY IN RESPONDING TO THE CMS 2567?
KINGSHUK DAS: YES, THERE WAS.
MR. LEACH: WHY WAS THAT?
KINGSHUK DAS: I BELIEVE THERE WAS A DEADLINE IMPOSED BY CMS FOR A RESPONSE.
MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION BACK TO 4621.
KINGSHUK DAS: YES.
MR. LEACH: AND I'D LIKE TO FOCUS ON THE COVER LETTER, PAGES 1 THROUGH 4. ON PAGE 2, DO YOU SEE REFERENCE TO, IN PARAGRAPH 3, A DEADLINE IMPOSED BY CMS?
KINGSHUK DAS: YES, I DO.
MR. LEACH: OKAY. AND ON -- ABOVE THAT DO YOU SEE SOME LANGUAGE SUGGESTING REASONING BEHIND THE DATE THAT IS BEING IMPOSED BY CMS?
MR. WADE: YOUR HONOR, THE DOCUMENT IS NOT IN EVIDENCE, BUT WE'RE REFERRING TO SUBSTANTIAL PARTS OF IT HERE.
JUDGE DAVILA: MR. LEACH?
MR. LEACH: I'M TRYING TO LAY A FOUNDATION TO ADMIT IT INTO EVIDENCE, YOUR HONOR, AND I THINK MY NEXT QUESTION IS, DID HE DISCUSS THIS WITH MS. HOLMES?
JUDGE DAVILA: ALL RIGHT. THANK YOU.
BY MR. LEACH:
MR. LEACH: DID YOU DISCUSS THE CIRCUMSTANCES DESCRIBED IN THIS LETTER WITH MS. HOLMES?
KINGSHUK DAS: YES, THE CIRCUMSTANCES WERE DESCRIBED OR DISCUSSED.
MR. LEACH: YOUR HONOR, I OFFER PAGES 1 THROUGH 4 OF EXHIBIT 4621.
MR. WADE: YOUR HONOR, WE OBJECT TO ALL OF THE REFERENCE OF THE EXHIBIT FOR REASONS WE DISCUSSED WITH COUNSEL AND THE COURT THIS MORNING AND THE REASONS SET FORTH IN THE MOTION PAPERS.
JUDGE DAVILA: ALL RIGHT. THANK YOU. SO YOU'RE ASKING FOR 1 THROUGH 4 ONLY?
MR. LEACH: YES.
JUDGE DAVILA: OF 4621?
MR. LEACH: YES.
JUDGE DAVILA: ALL RIGHT. I DO YOU THINK AN APPROPRIATE FOUNDATION HAS BEEN LAID TO ADMIT THIS, OVERRULING THE OBJECTIONS THAT WERE MADE EARLIER. SO THIS WILL BE ADMITTED OVER OBJECTION. THANK YOU.
MR. LEACH: THANK YOU.
JUDGE DAVILA: AND IT CAN BE, IT CAN BE DISPLAYED IF YOU WISH.
(GOVERNMENT'S EXHIBIT 4621, PAGES 1 THROUGH 4, WAS RECEIVED IN EVIDENCE.)
MR. LEACH: IF WE CAN PLEASE START AT THE TOP, MS. HOLLIMAN, CATCHING THE CMS HEADER IF YOU COULD, PLEASE.
MR. LEACH: DR. DHAWAN, IS THIS THE COVER LETTER THAT ACCOMPANIED CMS DEFICIENCY NOTICE?
KINGSHUK DAS: I'M SORRY.
MR. LEACH: I'M TERRIBLY SORRY, I'M READING THE DOCUMENT AND MOVING TOO QUICKLY. DR. DAS, IS THIS THE COVER LETTER THAT ACCOMPANIED THE STATEMENT OF DEFICIENCIES FROM CMS?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND DO YOU SEE THE DATE JANUARY 25TH, 2016?
KINGSHUK DAS: I DO.
MR. LEACH: OKAY. AND THIS IS ADDRESSED TO SOMEONE NAMED SUNIL DHAWAN. DID YOU HAVE AN UNDERSTANDING OF WHO SUNIL DHAWAN WAS?
KINGSHUK DAS: YES.
MR. LEACH: AND WHO WAS HE?
KINGSHUK DAS: MY UNDERSTANDING IS THAT HE WAS THE PRIOR LABORATORY DIRECTOR BEFORE I JOINED.
MR. LEACH: IN THE RE LINE, IT SAYS, CONDITION LEVEL DEFICIENCIES - IMMEDIATE JEOPARDY. DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND THEN IN THE FIRST PARAGRAPH -- WELL, I'M SORRY, IN THE SECOND PARAGRAPH IT SAYS, "THE CENTERS FOR MEDICARE AND MEDICAID SERVICES CONDUCTED A CLIA RECERTIFICATION AND COMPLAINT SURVEY OF THE LABORATORY." I'LL RESTATE, MS. RODRIGUEZ. THANK YOU. IS IT YOUR UNDERSTANDING THAT A SURVEY WAS PERFORMED BY CMS PRIOR TO JANUARY THAT GENERATED THIS STATEMENT OF DEFICIENCIES?
KINGSHUK DAS: YES, THAT IS MY UNDERSTANDING.
MR. LEACH: OKAY. IT GOES ON TO SAY, "THE ONSITE SURVEY WAS COMPLETED ON NOVEMBER 20TH, 2015. HOWEVER, THE SURVEY CONCLUDED WITH THE RECEIPT OF CRITICAL INFORMATION RECEIVED FROM THE LABORATORY ON DECEMBER 23RD, 2015." DO YOU SEE THAT?
KINGSHUK DAS: YES, I DO.
MR. LEACH: THEN IT SAYS, "AS A RESULT OF THE SURVEY, IT WAS DETERMINED THAT YOUR FACILITY WAS NOT IN COMPLIANCE WITH ALL OF THE CONDITIONS REQUIRED FOR CERTIFICATION IN THE CLIA PROGRAM." DO YOU SEE THAT?
KINGSHUK DAS: I DO.
MR. LEACH: AND IS "CONDITIONED" A TERM OF ART IN THE CLIA REGULATIONS?
KINGSHUK DAS: YES, THAT IS.
MR. LEACH: AND WHAT IS A CONDITION?
KINGSHUK DAS: THESE ARE ANALOGOUS TO REQUIREMENTS OR REGULATIONS.
MR. LEACH: OKAY. IT THEN SAYS, "IN ADDITION, BASED ON THE CONDITION-LEVEL REQUIREMENT, HEMATOLOGY, IT WAS DETERMINED THAT THE DEFICIENT PRACTICES OF THE LABORATORY POSE IMMEDIATE JEOPARDY TO PATIENT HEALTH AND SAFETY." DO YOU SEE THAT?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND IS THAT PART OF WHAT WAS TRIGGERING THE URGENCY FOR YOUR RESPONSE TO CMS?
KINGSHUK DAS: YES, THAT IS CORRECT.
MR. LEACH: AND DID YOU HAVE DISCUSSIONS WITH MS. HOLMES ABOUT THE NEED TO RESPOND URGENTLY TO CMS?
KINGSHUK DAS: YES, WE DID.
MR. LEACH: FURTHER DOWN THERE'S A LIST OF CONDITIONS THAT WERE NOT MET. IF WE CAN ZOOM OUT, MS. HOLLIMAN AND HIGHLIGHT THE BOTTOM. DR. DAS, DO YOU SEE THE REFERENCE D5024 COLON, AND THEN A REFERENCE TO 42 CFR WITH ANOTHER NUMBER?
KINGSHUK DAS: YES, I SEE THAT.
MR. LEACH: OKAY. DO YOU HAVE AN UNDERSTANDING OF WHAT THAT D NUMBER REFERENCES?
KINGSHUK DAS: D IS REFERENCING A DEFICIENCY.
MR. LEACH: AND THE 42 CFR, IS THAT A REFERENCE TO A PARTICULAR CLIA REGULATION?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: AND THIS PARTICULAR REFERENCE IS A REFERENCE TO HEMATOLOGY?
KINGSHUK DAS: THAT IS MY UNDERSTANDING.
MR. LEACH: AND WHAT IS HEMATOLOGY?
KINGSHUK DAS: IT'S A STUDY OF THE BLOOD.
MR. LEACH: THE NEXT TAG D5400. DO YOU SEE THAT?
KINGSHUK DAS: I DO.
MR. LEACH: AND TO THE RIGHT, THIS RELATES TO A CONDITION FOR ANALYTIC SYSTEMS. IS THAT A TERM THAT YOU'RE FAMILIAR WITH IN THE CLIA REGULATIONS?
KINGSHUK DAS: YES, I'M FAMILIAR WITH THAT TERM.
MR. LEACH: AND WHAT DOES THAT REFER TO?
KINGSHUK DAS: IT GENERALLY REFERS TO INSTRUMENTS AND METHODS USED FOR TESTING.
MR. LEACH: AND THEN D6076, DO YOU SEE THAT NUMBER IN THE THIRD ROW?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND THIS CONDITION IS LABORATORIES PERFORMING HIGH COMPLEXITY TESTING; LABORATORY DIRECTOR. DO YOU SEE THAT REFERENCE?
KINGSHUK DAS: I DO.
MR. LEACH: AND THERANOS'S CLIA LABORATORY IN CALIFORNIA WAS A HIGH COMPLEXITY LAB?
KINGSHUK DAS: THAT IS CORRECT.
MR. LEACH: DESCRIBE FOR US HOW YOU WENT ABOUT RESPONDING TO CMS. WHAT DID YOU DO IN TERMS OF RESPONDING TO THIS LETTER FROM CMS?
KINGSHUK DAS: HONESTLY, THE FIRST STEP WAS TO READ THE STATEMENT OF DEFICIENCIES VERY CAREFULLY TO UNDERSTAND THE SPECIFICS OF THE DEFICIENCIES.
MR. LEACH: AND I TRUST YOU DID THAT.
KINGSHUK DAS: YES, WE DID.
MR. LEACH: OKAY. AND DID YOU HAVE MULTIPLE DISCUSSIONS WITH YOUR TEAM ABOUT THE DEFICIENCIES THAT CMS IDENTIFIED?
KINGSHUK DAS: YES, WE DID.
MR. LEACH: DID YOU HAVE MULTIPLE DISCUSSIONS WITH MS. HOLMES ABOUT THE DEFICIENCIES THAT CMS IDENTIFIED?
KINGSHUK DAS: YES. SHE WAS PART OF SOME OF THOSE DISCUSSIONS.
MR. LEACH: OKAY. LET ME -- I WANT TO DRAW YOUR ATTENTION, PLEASE, TO PARTICULAR PROVISIONS WITHIN 2567, AND IF I COULD DRAW YOUR ATTENTION, PLEASE, TO -- AND LET'S NOT DISPLAY THIS, MS. HOLLIMAN. BUT IF I COULD PLEASE DRAW YOUR ATTENTION TO PAGE 51.
JUDGE DAVILA: I'M SORRY, WHAT PAGE?
MR. LEACH: 51, YOUR HONOR.
JUDGE DAVILA: THANK YOU.
KINGSHUK DAS: OKAY.
BY MR. LEACH:
MR. LEACH: BEFORE I ASK QUESTIONS ABOUT PAGE 51, AFTER REVIEWING THE CMS STATEMENT OF DEFICIENCIES IN ITS ENTIRETY, DID YOU LOOK AT THE CATEGORIES OF DOCUMENTS THAT YOU DESCRIBED EARLIER?
KINGSHUK DAS: NOT IMMEDIATELY.
MR. LEACH: AT SOME POINT DID YOU?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU LOOK AT THE DOCUMENTS THAT WERE REFERENCED IN THE CMS STATEMENT OF DEFICIENCIES TO UNDERSTAND WHAT THEY WERE REFERRING TO?
KINGSHUK DAS: YES, THAT'S CORRECT.
MR. LEACH: AND DID YOU HAVE DISCUSSION WITH YOUR TEAM ABOUT THOSE?
KINGSHUK DAS: YES, WE DID.
MR. LEACH: DID YOU, AND DID YOU HAVE DISCUSSIONS WITH MS. HOLMES ABOUT THAT?
KINGSHUK DAS: TO SOME EXTENT, YES.
MR. LEACH: LET ME DRAW YOUR ATTENTION -- WE'RE ON PAGE 51. AT THE BOTTOM, DO YOU SEE ANOTHER ONE OF THOSE D NUMBERS TO THE LEFT AT THE BOTTOM?
KINGSHUK DAS: I DO.
MR. LEACH: AND IF I COULD ASK YOU, PLEASE, TO CONTINUE READING -- OR IF I COULD ASK YOU TO CONTINUE READING TO THE NEXT PAGE, DO YOU SEE AT THE TOP LANGUAGE, A REFERENCE TO A STANDARD?
KINGSHUK DAS: MR. LEACH, IF I MAY? ARE YOU REFERRING TO D5791?
MR. LEACH: YES.
KINGSHUK DAS: AND READ UNTIL WHEN?
MR. LEACH: IF YOU COULD PLEASE READ UNTIL PAGE 52, THERE'S A REFERENCE TO STANDARD AT THE TOP. DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: I DO.
MR. LEACH: AND --
KINGSHUK DAS: PLEASE GIVE ME A MINUTE.
MR. WADE: COUNSEL, IF I MAY INQUIRE, YOU'RE REFERRING TO THE PAGE NUMBERS IN THE MIDDLE OF THE DOCUMENT OR THE DOCUMENT ITSELF?
MR. LEACH: THE TRIAL EXHIBIT NUMBER.
BY MR. LEACH:
MR. LEACH: AND DO YOU SEE A NUMBER 1 BENEATH THAT STANDARD LANGUAGE?
KINGSHUK DAS: YES, I DO.
MR. LEACH: OKAY. I WANT TO SKIP OVER THE SUBSTANCE OF WHAT IS IN NUMBER 1 AND GO TO NUMBER 2 ON THE NEXT PAGE, PAGE 53.
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND DO YOU SEE A DESCRIPTION RELATING TO SOMETHING CALLED TPS IN NUMBER 2 DOWN AT THE BOTTOM OF PAGE 53?
KINGSHUK DAS: I DO.
MR. LEACH: OKAY. AND ARE YOU FAMILIAR WITH THIS PORTION OF THE 2567?
KINGSHUK DAS: I'LL HAVE TO REVIEW IT CAREFULLY.
MR. LEACH: IF YOU COULD REVIEW CAREFULLY PAGES 53, 54, UP TO NUMBER 3 ON PAGE 55.
(PAUSE IN PROCEEDINGS.)
KINGSHUK DAS: OKAY. I'VE HAD A CHANCE TO REVIEW THIS.
BY MR. LEACH:
MR. LEACH: OKAY. ARE YOU FAMILIAR WITH THIS PORTION OF FORM 2567?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND DID YOU DISCUSS ISSUES RELATING TO QUALITY CONTROL AND THE EDISON DEVICE WITH MS. HOLMES?
KINGSHUK DAS: YES, WE HAD DISCUSSED THAT.
MR. LEACH: YOUR HONOR, I OFFER PAGES 51 FROM THE BOTTOM -- WITH THE D TAG BEGINNING D5791, THE TOP OF PAGE 52 WHERE IT SAYS "THE STANDARD IS" WITH SOME ADDITIONAL LANGUAGE THERE.
JUDGE DAVILA: LET ME -- YOU SAID 51 FROM D5791?
MR. LEACH: YES.
JUDGE DAVILA: OKAY.
MR. LEACH: ALL THE WAY DOWN TO PAGE 52 DOWN TO THE LINE INCLUDING "THIS STANDARD," AND THEN CONTINUING ON THE BOTTOM OF PAGE 53 FROM THE INFORMATION UNDER NUMBER 2 TO PAGE 55 WITH THE INFORMATION NUMBERED L.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: OKAY. MR. LEACH, MAYBE YOU SHOULD JUST WALK OVER AND SHOW MR. WADE WHERE IT IS.
MR. LEACH: SURE.
(DISCUSSION OFF THE RECORD.)
JUDGE DAVILA: THANK YOU. I'LL NOTE THOSE OBJECTIONS AND NOTE THE FOUNDATION THAT HAS BEEN LAID THIS AFTERNOON WITH TESTIMONY. SO THE OBJECTION IS OVERRULED.
(GOVERNMENT'S EXHIBIT 4621B, REDACTED PAGES 51 - 55, WAS RECEIVED IN EVIDENCE.)
MR. LEACH: THANK YOU, YOUR HONOR. AND WE'LL DO OUR BEST TO DISPLAY JUST THOSE PORTIONS. SO, MS. HOLLIMAN, IF WE COULD PLEASE DISPLAY PAGE 51, BEGINNING -- REDACTING EVERYTHING EXCEPT THE BOTTOM OF THE PAGE STARTING WITH 5791.
JUDGE DAVILA: AND, MR. LEACH, THESE ARE ADMITTED FOR -- I KNOW WE'VE DISCUSSED THIS -- FOR STATE OF MIND ISSUES?
MR. LEACH: YES, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU. SO, LADIES AND GENTLEMEN, THESE PAGES THAT YOU'RE ABOUT TO SEE ARE ADMITTED FOR THE STATE OF MIND OF THE DEFENDANT, MR. LEACH?
MR. LEACH: YES, YOUR HONOR.
JUDGE DAVILA: YES. AS TO ANY ISSUE OF INTENT AND KNOWLEDGE.
(PAUSE IN PROCEEDINGS.)
MR. LEACH: JUST ONE MOMENT, YOUR HONOR.
JUDGE DAVILA: YES, OF COURSE.
(PAUSE IN PROCEEDINGS.)
MR. WADE: YOUR HONOR, WHILE COUNSEL IS LOOKING FOR THAT, I MIGHT JUST CLARIFY. I UNDERSTAND THE COURT'S DIRECTION OF THE LIMITED PURPOSE FOR WHICH THEY'RE OFFERED FOR, BUT I JUST MIGHT ASK THAT IT BE CLARIFIED, BUT NOT FOR THE TRUTH OF THE MATTER ASSERTED.
JUDGE DAVILA: THAT WAS YOUR INTENT AS WELL, MR. LEACH?
MR. LEACH: YES.
JUDGE DAVILA: LADIES AND GENTLEMEN, AS I SAID -- THANK YOU, MR. WADE. AS I SAID EARLIER, THESE ARE RECEIVED NOT FOR THE TRUTH OF THE MATTER ASSERTED IN EACH OF THE DOCUMENTS, BUT THEY ARE ADMITTED ONLY AS TO THE ISSUE OF KNOWLEDGE AND INTENT AS TO THE DEFENDANT MS. HOLMES.
(PAUSE IN PROCEEDINGS.)
MR. LEACH: YOUR HONOR, WE'RE HAVING SOME TECHNICAL ISSUES WITH THE REDACTIONS AND DISPLAYING THEM UP THERE. I THINK WHILE WE'RE RESOLVING THAT I'D LIKE TO GO THROUGH ADDITIONAL PORTIONS OF THIS AND MAKE MY OFFER OF PROOF AND HOPEFULLY SAVE EVERYBODY SOME TIME THAT WAY.
JUDGE DAVILA: IT SEEMS TO BE THE ORDER OF THE DAY.
MR. LEACH: I APOLOGIZE TO THE COURT AND APPRECIATE EVERYONE'S PATIENCE.
MR. LEACH: BEFORE WE DISPLAY THE PORTIONS THAT WERE JUST ADMITTED, DR. DAS, LET ME DRAW YOUR ATTENTION TO PAGE 55 OF EXHIBIT 4621, THE COVER LETTER AND THE STATEMENT OF DEFICIENCIES.
KINGSHUK DAS: YES.
MR. LEACH: AND DO YOU SEE THE NUMBER 3 IN THE COLUMN FOR SUMMARY STATEMENT OF DEFICIENCIES?
KINGSHUK DAS: I DO.
MR. LEACH: OKAY. AND PLEASE TAKE A MOMENT TO READ TO YOURSELF THE INFORMATION BEGINNING AT 3 AND CONTINUING TO PAGE 57 THROUGH THE SUBSTANCE OF NUMBER K IN THE MIDDLE OF THE PAGE.
(PAUSE IN PROCEEDINGS.)
KINGSHUK DAS: THANKS FOR YOUR PATIENCE.
BY MR. LEACH:
MR. LEACH: HAVE YOU READ THOSE CAREFULLY TO YOURSELF?
KINGSHUK DAS: I HAVE.
MR. LEACH: AND IN THE MARCH AND APRIL TIME PERIOD, DID YOU HAVE CONVERSATIONS WITH MS. HOLMES ABOUT THERANOS'S QUALITY CONTROL RESULTS FOR THE TIME PERIOD JULY 2014 THROUGH JUNE OF 2015?
KINGSHUK DAS: YES, WE DID.
MR. LEACH: YOUR HONOR, I OFFER PAGE 55, BEGINNING FROM THE NUMBER 3 ALL OF THE WAY THROUGH PAGE 57, STOPPING AT THE NUMBER -- JUST ABOVE THE NUMBER 4.
JUDGE DAVILA: MR. LEACH, COULD YOU TELL ME -- YOUR LAST QUESTION WAS REGARDING CONVERSATIONS THAT THIS WITNESS HAD WITH MS. HOLMES BETWEEN, WHAT WAS THE TIME PERIOD?
MR. LEACH: BETWEEN JULY -- RELATING TO QC DATA BETWEEN JULY OF 2014 AND JUNE OF 2015.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: COUNSEL?
JUDGE DAVILA: IT'S NOT FOR THE TRUTH OF THE MATTER -- IS THIS LIKEWISE AS THE PREVIOUS ADMISSIONS?
MR. LEACH: YES, YOUR HONOR, FOR STATE OF MIND.
JUDGE DAVILA: YES.
JUDGE DAVILA: ALL RIGHT. THANK YOU. LADIES AND GENTLEMEN -- OVERRULED. LADIES AND GENTLEMEN, THESE EXHIBITS WILL BE ADMITTED, AND THEY ARE OFFERED NOT FOR THE TRUTH OF THE MATTER ASSERTED, BUT ONLY AS TO THE STATE OF MIND OF MS. HOLMES, AS THE PREVIOUS ADMISSIONS, AS TO INTENT AND KNOWLEDGE, AND THOSE ISSUES ONLY, NOT FOR THE TRUTH OF THE MATTER ASSERTED, BUT ONLY AS TO THE STATE OF MIND OF MS. HOLMES AS TO KNOWLEDGE AND INTENT.
(GOVERNMENT'S EXHIBIT 4621, PAGE 55 WAS RECEIVED IN EVIDENCE.)
MR. LEACH: MS. HOLLIMAN, IF WE'RE ABLE TO, I THINK WE CAN NOW DISPLAY THE ENTIRETY OF PAGE 55.
(PAUSE IN PROCEEDINGS.)
MR. LEACH: OKAY. MS. HOLLIMAN, IF WE CAN PLEASE ZOOM IN ON THE TOP PORTION OF PAGE 55 JUST TO ORIENT THE JURY AT THE TOP OF THE PAGE.
MR. LEACH: DR. DAS, DO YOU SEE THE TOP PORTION OF PAGE 55 ON TRIAL EXHIBIT 4621?
KINGSHUK DAS: I DO.
MR. LEACH: OKAY. AND DO YOU SEE THE DATE IN THE UPPER RIGHT CORNER, JANUARY 25TH, 2016?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND TO THE LEFT OF THE PAGE THERE'S A BOX "STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION." IS THAT PART OF THE CMS FORM?
KINGSHUK DAS: YES, IT IS.
MR. LEACH: AND TO THE RIGHT DO YOU SEE THE DATE OF NOVEMBER 20TH, 2015?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND IS THAT YOUR UNDERSTANDING OF THE DATE THAT THE CMS SURVEY WAS COMPLETED?
KINGSHUK DAS: THAT IS MY UNDERSTANDING.
MR. LEACH: OKAY. THERE'S A STREET ADDRESS LISTED FOR THE LABORATORY, 733 GATEWAY BOULEVARD. IS THAT WHERE THE CLIA LABORATORY WAS LOCATED?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: THAT'S WHERE YOU WENT TO WORK IN YOUR JOB?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. IF WE COULD PLEASE ZOOM OUT, MS. HOLLIMAN. IF WE CAN NOW CAPTURE EVERY -- THE TOP -- DOWN A LITTLE BIT MORE TO NUMBER 3. DR. DAS, DO YOU SEE THE NUMBER D5791 --
KINGSHUK DAS: I DO.
MR. LEACH: -- IN THE TOP LEFT CORNER? AND IS THAT A REFERENCE TO SOME IDENTIFICATION TAG OR PREFIX TAG?
KINGSHUK DAS: THAT'S CORRECT, D TAG.
MR. LEACH: OKAY. WHAT DO YOU MEAN, D TAG?
KINGSHUK DAS: DEFICIENCY TAG.
MR. LEACH: AND DOWN ON 3 IT SAYS, "BASED ON REVIEW OF QUALITY ASSESSMENT AND QA PROCEDURES, THE LABORATORY FAILED TO HAVE A QUALITY ASSESSMENT PROCEDURE ESTABLISHED TO IDENTIFY AND CORRECT PROBLEMS WITH THE QUALITY CONTROL PROGRAM FOR THE THERANOS PROPRIETARY SYSTEM (TPS)." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND DID YOU UNDERSTAND TPS TO BE THE EDISON 3.5 DEVICE?
KINGSHUK DAS: YES.
MR. LEACH: AND WHAT DID YOU UNDERSTAND QUALITY ASSESSMENT TO MEAN?
KINGSHUK DAS: MEANING THE TERM, MR. LEACH?
MR. LEACH: YES.
KINGSHUK DAS: THAT'S A TERM THAT ENCOMPASSES ALL QUALITY PROGRAMS, NOT INCLUDING QUALITY CONTROL.
MR. LEACH: AND WHAT DO YOU MEAN BY "QUALITY PROGRAMS"?
KINGSHUK DAS: IN GENERAL, QUALITY CONTROL HAS TO DO WITH DAY-TO-DAY RUNS, QUALITY OF DAY-TO-DAY RUNS. AND QUALITY ASSESSMENT IS -- DESCRIBES ALL OF THE OTHER QUALITY ACTIVITIES OUTSIDE OF THE DAY-TO-DAY RUNS ON ANY GIVEN INSTRUMENT.
MR. LEACH: AND WAS PART OF YOUR JOB AS THE LAB DIRECTOR TO INVESTIGATE THIS FINDING, UNDERSTAND IT, AND COME UP WITH THE COMPANY'S RESPONSE?
KINGSHUK DAS: YES.
MR. LEACH: IF WE CAN GO FURTHER DOWN, PLEASE, MS. HOLLIMAN, ON PAGE 55. IT READS HERE, "MONTHLY QC REPORTS WERE REVIEWED FOR JULY 2014, OCTOBER 2014, AND FEBRUARY THROUGH JUNE 2015." DID YOU ALSO REVIEW MONTHLY QC REPORTS IN THE COURSE OF YOUR WORK AS THE LABORATORY DIRECTOR?
KINGSHUK DAS: WE DID. WE HAD THE REPORTS CREATED FOR US.
MR. LEACH: OKAY. AND THAT WAS IN PART TO RESPOND TO THE 2567?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: AND IN NUMBER 2 IT SAYS, "THE TOTAL PERCENTAGE OF QC VALUES GREATER THAN 2 STANDARD DEVIATIONS (SDS) WAS REVIEWED BY THE SURVEYOR." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: I DO.
MR. LEACH: AND DO YOU UNDERSTAND WHAT IS MEANT BY "STANDARD DEVIATIONS"?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND WHAT IS A STANDARD DEVIATION?
KINGSHUK DAS: WOULD YOU LIKE THE MORE TECHNICAL DEFINITION?
MR. LEACH: I'D LIKE THE LESS TECHNICAL DEFINITION IF YOU COULD.
KINGSHUK DAS: IT'S, IN GENERAL, AN ESTIMATE OF THE SPREAD OF A DATA SET, HOW WIDELY THE VALUES VARY.
MR. LEACH: OKAY.
KINGSHUK DAS: IN LABORATORY PARLANCE, WE USE IT TO ESTIMATE PRECISION.
MR. LEACH: AND IF WE CAN GO TO THE NEXT PAGE, PLEASE, PAGE 56. DR. DAS, DO SOME OF THE CMS FINDINGS CONTINUE -- WITH RESPECT TO THIS D TAG CONTINUE ON TO THE NEXT PAGE?
KINGSHUK DAS: YES, I SEE THAT.
MR. LEACH: OKAY. DO YOU SEE WHERE IT SAYS, "IN JULY 2014, THE DATA REVEALED THE FOLLOWING TESTS SHOWED PERCENTAGE OF QC SAMPLES WITH MORE THAN 15 PERCENT OF VALUES GREATER THAN 2 SD." AND THEN THERE'S TESTOSTERONE, TOTAL T4, VITAMIN D. "OVERALL 16 PERCENT OF QC SAMPLES ON ALL TESTS ON ALL DEVICES HAD VALUES GREATER THAN 2 SDS." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: I DO SEE THAT.
MR. LEACH: OKAY. AND WERE TST, TOTAL T4, AND VITAMIN D ASSAYS RUN ON THE EDISON IN THE 2014 TIME PERIOD?
KINGSHUK DAS: THAT IS CORRECT. I BELIEVE THAT'S WHAT THEY'RE REFERRING TO.
MR. LEACH: AND DID YOU AND YOUR TEAM ALSO REVIEW THE DATA THAT IS LISTED HERE ON THIS FORM?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU REVIEW AN EVEN BROADER UNIVERSE OF QC DATA IN ORDER TO RESPOND TO THE CMS REPORT?
KINGSHUK DAS: WE DID.
MR. LEACH: AND IS THIS -- IS THE FINDING LISTED HERE CONSISTENT WITH WHAT YOU REVIEWED IN YOUR REVIEW OF DATA?
MR. WADE: YOUR HONOR, 702 ON THIS ISSUE, PARTICULARLY GIVEN THE PURPOSE THAT THIS EVIDENCE HAS BEEN OFFERED.
JUDGE DAVILA: MR. LEACH, I THINK YOU'RE ON THE MARGINS OF A 702 AREA, SO LET ME ASK YOU TO REPHRASE YOUR QUESTION.
BY MR. LEACH:
MR. LEACH: DID YOU ALSO -- DID YOU ALSO REVIEW THE DATA THAT IS LISTED IN THIS REPORT, IN THIS PARAGRAPH E, DR. DAS?
KINGSHUK DAS: I DON'T RECALL THESE EXACT NUMBERS, BUT THESE TIME FRAMES ARE CONSISTENT WITH MY RECOLLECTION.
MR. LEACH: OKAY. AND IN RESPONDING TO CMS, DID -- OR YOU NEEDED TO FORMULATE A RESPONSE TO CMS ON BEHALF OF THE COMPANY; IS THAT CORRECT?
KINGSHUK DAS: YES, THAT IS CORRECT.
MR. LEACH: AND DID YOU LOOK AT NOT JUST DATA FOR JULY OF 2014, BUT A BROADER UNIVERSE OF DATA IN ORDER TO UNDERSTAND AND RESPOND TO CMS?
KINGSHUK DAS: YES, WE DID.
MR. LEACH: OKAY. AT ANY POINT DID YOU TELL CMS THAT THE COMPANY DISAGREED WITH THIS PARTICULAR FINDING?
KINGSHUK DAS: NO, I DON'T BELIEVE WE DID.
MR. LEACH: OKAY. WHY NOT?
KINGSHUK DAS: THESE FINDINGS --
JUDGE DAVILA: I UNDERSTAND. I THINK YOU'RE ASKING FOR AN OPINION THAT FALLS UNDER 702 THE WAY THE QUESTION IS FORMED, SO I'LL SUSTAIN THE OBJECTION.
BY MR. LEACH:
MR. LEACH: BUT YOU NEVER SAID TO ANYBODY AT CMS, "I DISAGREE WITH THIS FINDING"?
KINGSHUK DAS: I DON'T RECALL SAYING THAT OR WRITING THAT.
MR. LEACH: LET'S GO TO NUMBER F.
KINGSHUK DAS: OKAY.
MR. LEACH: AND IF WE CAN ENLARGE THAT, MS. HOLLIMAN. I'M SORRY. I THINK WE'RE DOWN ON H. I WANTED TO FOCUS ON F IF WE COULD: THIS READS, DR. DAS, "IN OCTOBER 2014 THE DATA REVEALED THE FOLLOWING TESTS SHOWED PERCENTAGE OF QC SAMPLES WITH MORE THAN 15 PERCENT OF VALUES GREATER THAN 2 SD." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: I DO.
MR. LEACH: AND THEN THERE'S A LIST FOR ESTRADIOL, FREE T4, PROLACTIN, SHBG, TSH, TST, TOTAL T3, TT4, VITAMIN D, AND VITAMIN B12. DO YOU SEE THOSE?
KINGSHUK DAS: I DO.
MR. LEACH: AND ARE ALL OF THOSE ASSAYS THAT WERE RUN ON THE EDISON?
KINGSHUK DAS: YES.
MR. LEACH: AND AS A LAB DIRECTOR, IS IT DESIRABLE OR UNDESIRABLE TO HAVE A CV OF GREATER THAN 15 PERCENT?
KINGSHUK DAS: THAT WOULD BE UNDESIRABLE.
MR. LEACH: THIS SAYS, "OVERALL 29 PERCENT OF QC SAMPLES ON ALL TESTS ON ALL DEVICES HAD VALUES GREATER THAN 2 SD'S." DO YOU SEE THAT?
KINGSHUK DAS: YES, I SEE THAT.
MR. LEACH: AND WHAT DID YOU UNDERSTAND THAT TO MEAN?
KINGSHUK DAS: THAT -- I UNDERSTAND THAT TO MEAN THAT 15 PERCENT OF THE VALUES WERE VIOLATING THE 2 SD RULE, WHICH IS A COMMON QUALITY CONTROL RULE.
MR. LEACH: AND DID YOU HAVE DISCUSSIONS WITH MS. HOLMES ABOUT THIS QUALITY CONTROL RULE AND THE DATA THAT WAS BEING REPORTED BY CMS?
KINGSHUK DAS: IN GENERAL, YES.
MR. LEACH: LET'S GO TO LETTER G. DO YOU SEE WHERE IT SAYS, "IN FEBRUARY OF 2015, THE DATA" -- OH, BEFORE I LEAVE G, DID YOU EVER TELL CMS THAT YOU DISAGREED WITH THIS FINDING IN F?
JUDGE DAVILA: OVERRULED. YOU CAN ANSWER THE QUESTION.
KINGSHUK DAS: NO, I DO NOT RECALL THAT.
BY MR. LEACH:
MR. LEACH: IN G IT SAYS, "IN FEBRUARY 2015, THE DATA REVEALED THE FOLLOWING TESTS SHOWED THE PERCENTAGE OF QC SAMPLES WITH MORE THAN 15 PERCENT OF VALUES GREATER THAN 2 SD." AND IT LISTS FT4, SHBG, TT3, VITAMIN D, VITAMIN B12. DO YOU SEE THAT?
KINGSHUK DAS: I DO.
MR. LEACH: AND THOSE ARE TESTS THAT ARE RUN ON EDISON?
KINGSHUK DAS: THAT IS CORRECT.
MR. LEACH: AND AT ANY POINT IN TIME DID YOU TELL CMS THAT YOU DISAGREED WITH THIS FINDING?
KINGSHUK DAS: NO, I DON'T RECALL DOING SO.
MR. LEACH: LET'S LOOK AT H AND I. DO YOU SEE WHERE IT SAYS, "IN MARCH OF 2015, THE DATA REVEALED THE FOLLOWING TESTS SHOWED PERCENTAGE OF QC SAMPLES WITH MORE THAN 15 PERCENT OF VALUES GREATER THAN 2 SD." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: I DO.
MR. LEACH: OKAY. AND DID YOU UNDERSTAND THIS TO BE A SIMILAR ISSUE TO WHAT CMS WAS RAISING FOR FEBRUARY, OCTOBER, AND JULY?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND AT ANY POINT IN TIME DID YOU TELL CMS THAT YOU DISAGREED WITH THIS FINDING?
KINGSHUK DAS: NO, I DON'T RECALL DOING SO.
MR. LEACH: AND THEN I SAYS, "IN APRIL THE DATA REVEALED THE FOLLOWING TESTS, SHOWED PERCENTAGE OF QC SAMPLES WITH MORE THAN 15 PERCENT OF VALUES GREATER THAN 2 SD, SHBG," AND THEN THERE'S A LIST OF ASSAYS CONTINUING ON TO PAGE 57. IS THIS A SIMILAR ISSUE BEING RAISED IN THE FINDINGS THAT WE JUST LOOKED AT PREVIOUSLY?
KINGSHUK DAS: YES, I AGREE.
MR. LEACH: AT ANY POINT IN TIME DID YOU TELL CMS THAT YOU DISAGREED WITH THIS FINDING?
KINGSHUK DAS: NO, I DON'T RECALL DOING SO.
MR. LEACH: WAS TSA -- OR EXCUSE ME, PSA AN -- YOU CAN TAKE THIS DOWN, MS. HOLLIMAN. WAS PSA ANOTHER ASSAY THAT WAS RUN ON THE EDISON DEVICE IN THE TIME PERIOD BEFORE YOU BECAME THE LAB DIRECTOR?
KINGSHUK DAS: YES, THAT'S MY UNDERSTANDING.
MR. LEACH: OKAY. AND IN CONNECTION WITH YOUR REVIEW OF THE CMS REPORT AND RESPONDING TO CMS, DID YOU HAVE DISCUSSIONS WITH MS. HOLMES ABOUT WHAT CMS WAS FINDING WITH RESPECT TO CMS AND WHAT YOU WERE FINDING AND WHAT THAT -- HOW TO RESPOND TO THAT?
KINGSHUK DAS: I COULD USE A LITTLE MORE SPECIFICITY, MR. LEACH, IF YOU MAY.
MR. LEACH: THAT WAS A COMPOUND QUESTION. LET ME ASK IT BETTER. IN THIS 2015 OR 2016, MARCH AND APRIL TIME PERIOD, DID YOU HAVE DISCUSSIONS WITH MS. HOLMES ABOUT THE COMPANY'S PSA TEST?
KINGSHUK DAS: I DID.
MR. LEACH: AND WAS THAT IN THE CONTEXT OF SOME OF THE CMS FINDINGS AND HOW TO RESPOND TO THAT?
KINGSHUK DAS: IT WAS RELATED TO THE CMS FINDINGS.
MR. LEACH: OKAY. DESCRIBE TO US YOUR CONVERSATIONS WITH MS. HOLMES?
KINGSHUK DAS: I RECALL USING THE PSA TEST AS AN EXAMPLE OF THE EDISON'S ERROR PROPENSITY OR GENERATING ERROR -- ERRONEOUS RESULTS.
MR. LEACH: OKAY. AND DID YOU GIVE MS. HOLMES A PARTICULAR REASON WHY YOU THOUGHT THE EDISON WAS PRONE TO ERRONEOUS RESULTS?
KINGSHUK DAS: YES. IN REVIEWING THE DATA, IT ENDED UP BEING AN EASILY DIGESTIBLE EXAMPLE OF THE EDISON'S ERRORS AND THAT I RECALL QUITE A FEW FEMALE PATIENTS RETURNING PSA RESULTS, WHICH WOULD BE HIGHLY UNLIKELY.
MR. LEACH: WHY WAS THAT A RED FLAG TO YOU?
KINGSHUK DAS: BECAUSE FEMALES SHOULD GENERALLY NOT HAVE PSA DETECTABLE. IT SHOULD ONLY BE DETECTED IN MALES.
MR. LEACH: AND WHY WERE YOU BRINGING THIS TO MS. HOLMES'S ATTENTION?
KINGSHUK DAS: IT WAS JUST TO EXEMPLIFY WHAT WE WERE DISCUSSING REGARDING SOME OF THE ERRORS SEEN ON THE TSPU.
MR. LEACH: AND AFTER THIS CONVERSATION WITH MS. HOLMES, DID SHE COME BACK TO YOU ABOUT WITH ANY LITERATURE RELATING TO PSA RESULTS?
KINGSHUK DAS: YES, I BELIEVE SO. SHE OFFERED AN ALTERNATIVE EXPLANATION.
MR. LEACH: AND WHAT WAS THE ALTERNATIVE EXPLANATION?
KINGSHUK DAS: I DON'T REMEMBER THE DETAILS, BUT IT WAS ALONG THE LINES OF AN ARTICLE OR TWO DESCRIBING A FEW, I BELIEVE IT WAS A FRACTION OF A SUBSET OF A RARE BREAST CANCER AND THOUGH FEMALES FROM TIME TO TIME EXHIBITING PSA RESULTS FROM THEIR TUMORS.
MR. LEACH: AND WAS THAT EXPLANATION SATISFYING TO YOU?
KINGSHUK DAS: IT SEEMED IMPLAUSIBLE.
MR. LEACH: LET ME MOVE FORWARD IN TIME, PLEASE, TO THE END OF OR THE LATE TIME PERIOD OF MARCH OF 2016. HAVING REVIEWED THE FORM 2567, DID YOU WRITE BACK TO CMS WITH THE COMPANY'S RESPONSES?
KINGSHUK DAS: YES, I DO RECALL THAT.
MR. LEACH: OKAY. AND DID YOU -- YOU MENTIONED SOMETHING EARLIER CALLED A PATIENT IMPACT ASSESSMENT. WHAT IS THAT?
KINGSHUK DAS: YES. THOSE WERE DESCRIPTIONS OF OUR ASSESSMENTS ON OUR EVALUATION OF WHETHER THESE TESTS LED TO POTENTIAL FOR PATIENT HARM.
MR. LEACH: AND IN THE COURSE OF, IN THE COURSE OF PREPARING THESE PATIENT IMPACT ASSESSMENTS, WERE YOU -- DID YOU VIEW YOURSELF AS FULFILLING YOUR OBLIGATIONS AS THE CLIA LAB DIRECTOR?
KINGSHUK DAS: YES, I DID.
MR. LEACH: AND WHY DID YOU FEEL THAT WAS PART OF YOUR OBLIGATIONS AS THE CLIA LAB DIRECTOR?
KINGSHUK DAS: THAT'S NOT ONLY A REGULATORY OBLIGATION BUT A PROFESSIONAL ONE AND AN ETHICAL ONE AS WELL.
MR. LEACH: OKAY. LET ME DRAW YOUR ATTENTION BACK TO 7603, SPECIFICALLY PAGES 82 AND 83. DO YOU HAVE THAT IN FRONT OF YOU, DR. DAS?
KINGSHUK DAS: YES, I DO. THANK YOU.
MR. LEACH: OKAY. AND ON PAGE 82 THERE'S A CFR SECTION 493.1291, STANDARD TEST REPORT. DO YOU SEE THAT?
KINGSHUK DAS: YES, I SEE THAT.
MR. LEACH: AND IF YOU LOOK ON PAGE 83, THERE'S A SUBPARAGRAPH K. DO YOU SEE WHERE IT SAYS, "WHEN ERRORS IN THE REPORTED PATIENT TEST RESULTS ARE DETECTED, THE LABORATORY MUST DO THE FOLLOWING"?
KINGSHUK DAS: I DO SEE THAT.
MR. LEACH: OKAY. AND DOES THAT LAY OUT CERTAIN THINGS THAT YOU FELT AS THE LABORATORY DIRECTOR NEEDED TO BE DONE IF THE CONDITION IN K WAS SATISFIED?
KINGSHUK DAS: THAT'S CORRECT, THAT'S STANDARD PRACTICE.
MR. LEACH: OKAY. IN THE COURSE OF RESPONDING TO THE CMS 2567, DID YOU, AS THE LABORATORY, DETECT ERRORS IN THE PATIENT REPORTED TEST RESULTS?
KINGSHUK DAS: WE DID.
MR. LEACH: AND DID YOU FEEL THAT YOU WERE REQUIRED TO TAKE CERTAIN ACTION PURSUANT TO THIS CLIA REGULATION AND YOUR PROFESSIONAL RESPONSIBILITIES?
KINGSHUK DAS: YES, THAT'S CORRECT.
MR. LEACH: LET ME DRAW YOUR ATTENTION, PLEASE, TO EXHIBIT 4943. DO YOU HAVE THAT IN FRONT OF YOU, DR. DAS?
KINGSHUK DAS: YES, I DO.
MR. LEACH: DO YOU RECOGNIZE THE FIRST PAGE OF 4943?
KINGSHUK DAS: I DO IN GENERAL, NOT THE SPECIFIC PAGE, THOUGH.
MR. LEACH: OKAY. IN GENERAL, WHAT IS THIS?
KINGSHUK DAS: IT LOOKS LIKE IT'S A TABLE OF CONTENTS FOR THE EXHIBITS THAT WE SUBMITTED TO CMS AS EVIDENCE.
MR. LEACH: AS PART OF YOUR REVIEW AND RESPONSE TO THE 2567?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: OKAY. DO YOU SEE THAT THERE'S A ROW -- THE THIRD ROW FROM THE BOTTOM WITH TAB NUMBER 3?
KINGSHUK DAS: YES, I DO.
MR. LEACH: OKAY. AND WE CAN NOW TURN TO PAGE 9. DO YOU SEE THE HEADING PATIENT IMPACT ASSESSMENT?
KINGSHUK DAS: I DO. THE PRINT IS RATHER SMALL.
MR. LEACH: OKAY. WE'LL, WE'LL --
KINGSHUK DAS: WE'LL MANAGE.
MR. LEACH: AND IS THIS A PATIENT IMPACT ASSESSMENT THAT WAS PROVIDED TO CMS FOLLOWING YOUR REVIEW OF THE 2567?
KINGSHUK DAS: I'LL NEED JUST A MOMENT TO REVIEW IT.
MR. LEACH: YES. THANK YOU.
(PAUSE IN PROCEEDINGS.)
KINGSHUK DAS: YES, I BELIEVE SO.
MR. LEACH: YOUR HONOR, I OFFER PAGE 1 AND 9 OF 4943.
(PAUSE IN PROCEEDINGS.)
JUDGE DAVILA: ALL RIGHT. THANK YOU. THE COURT WILL OVERRULE THE OBJECTION. THE FOUNDATION HAS BEEN LAID. I THINK THERE WAS A PREVIOUS 407 OBJECTION THAT WAS MADE, AND THAT IS OVERRULED NOW BY THE TESTIMONY OF THE WITNESS. THE OBJECTION IS OVERRULED.
(GOVERNMENT'S EXHIBIT 4943, PAGES 1 AND 9, WAS RECEIVED IN EVIDENCE.)
MR. LEACH: THANK YOU, YOUR HONOR. MAY WE DISPLAY, YOUR HONOR?
JUDGE DAVILA: YES.
BY MR. LEACH:
MR. LEACH: JUST TO ORIENT THE JURY, DR. DAS, I WAS REFERENCING -- YOU BELIEVE THIS WAS A DOCUMENT THAT WAS SUBMITTED TO CMS?
KINGSHUK DAS: YES, I BELIEVE SO.
MR. LEACH: OKAY. AND WE WERE TALKING ABOUT THE THIRD ROW. TAB 3 THERE'S SOME REFERENCE TO TPS 3.5 EDISONS AND SOME CERTAIN FINDINGS IN THE 2567. AND DO YOU SEE THAT?
KINGSHUK DAS: YES, I DO.
MR. LEACH: OKAY. AND IF WE CAN PLEASE DISPLAY PAGE 9. AND LET'S HIGHLIGHT THE FIRST HALF OR BLOW UP, ENLARGE THE FIRST TOP HALF OF THE DOCUMENT RIGHT THERE ALL OF THE WAY DOWN TO PATIENT IMPACT. THAT'S FINE, MS. HOLLIMAN. THANK YOU. IS THIS SOMETHING THAT YOU HAD A HAND IN DRAFTING, DR. DAS?
KINGSHUK DAS: I DON'T REMEMBER THE SPECIFIC DOCUMENT, BUT IT DOES LOOK FAMILIAR.
MR. LEACH: OKAY. YOU RECALL WORKING ON PATIENT IMPACT ASSESSMENT IN RESPONSE TO 2567?
KINGSHUK DAS: YES, INDEED.
MR. LEACH: AND WAS THAT SOMETHING THAT YOU FELT YOU HAD TO DO AS THE LAB DIRECTOR?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: OKAY. UP AT THE TOP THERE'S A LIST OF DEFICIENCIES AND THERE'S SOME D TAGS, D5403, D5481, D5791, D6102, AND D6115. DO YOU SEE THOSE?
KINGSHUK DAS: I DO.
MR. LEACH: AND WHAT ARE THOSE?
KINGSHUK DAS: THOSE APPEAR TO BE THE SPECIFIC D TAGS REFERENCED IN THIS PATIENT IMPACT ASSESSMENT.
MR. LEACH: AND THOSE D TAGS ORIGINATE FROM THE 2567?
KINGSHUK DAS: THAT'S CORRECT.
MR. LEACH: AND EARLIER WE WERE LOOKING AT A D TAG FOR 2571, FINDING NUMBER 3?
KINGSHUK DAS: I BELIEVE WE WERE.
MR. LEACH: AND SO DO YOU BELIEVE THAT THIS PATIENT IMPACT ASSESSMENT RELATES TO THE PORTION OF THE CMS REPORT THAT WE JUST LOOKED AT?
KINGSHUK DAS: I EXPECT SO.
MR. LEACH: OKAY. THIS SAYS, "THE LABORATORY AGREES THAT ITS DESCRIPTION OF PRIOR ANALYSIS WERE LACKING SUFFICIENT DETAIL TO EXPLAIN THE CONCLUSIONS SUBMITTED IN THE RESPONSE." IS THAT A REFERENCE TO PRIOR RESPONSES THAT THERANOS HAD MADE TO CMS?
KINGSHUK DAS: I BELIEVE SO.
MR. LEACH: IT THEN READS, "UPON A REVIEW OF THAT RESPONSE, INCLUDING THE ENTIRETY OF THE PRIOR ANALYSIS OF TPS 3.5 QC DATA AND PATIENT TEST RESULT DISTRIBUTIONS FOR ALL ANALYTES DURING THE TIME PERIOD EXAMINED, THE LABORATORY MADE NOTE OF POOR QC PERFORMANCE THROUGHOUT." IS THAT AN ACCURATE STATEMENT?
KINGSHUK DAS: THAT IS AN ACCURATE STATEMENT.
MR. LEACH: AND THE PATIENT TEST RESULT DISTRIBUTIONS THAT YOU'RE TALKING ABOUT THERE, DID THAT REFER TO ALL TESTS RUN ON THE EDISON DEVICE?
KINGSHUK DAS: YES, ALL TESTS.
MR. LEACH: OKAY. AND DO YOU HAVE A MEMORY OF HOW MANY TESTS WERE RUN ON THE EDISON DEVICE?
KINGSHUK DAS: I BELIEVE IT WAS A TOTAL OF 12.
MR. LEACH: OKAY. TWELVE TESTS RUN ON THE EDISON DEVICE THROUGHOUT THE LIFE OF THE CLIA LAB?
KINGSHUK DAS: THAT IS MY UNDERSTANDING.
MR. LEACH: IT THEN SAYS, "THEREFORE, LABORATORY CONDUCTED AN EXPANDED RETROSPECTIVE ANALYSIS FOR 2014 AND 2015 QC DATA." WHAT DOES THAT MEAN?
KINGSHUK DAS: IN GENERAL THAT MEANS WE EXPAND THE RANGE OF THE QC DATA THAT WE LOOKED AT BECAUSE WE IDENTIFIED ISSUES WITH THE ORIGINAL DATA, MEANING WE WANTED TO SEE HOW FAR THE POOR PERFORMANCE EXTENDED.
MR. LEACH: YOU WANTED TO LOOK AT A BROADER UNIVERSE?
KINGSHUK DAS: YES, THAT'S ONE WAY TO DESCRIBE IT.
MR. LEACH: OKAY. AND THAT'S WHAT YOU'RE REPORTING TO CMS?
KINGSHUK DAS: YES, THAT'S CORRECT.
MR. LEACH: OKAY. AFTER EXTENSIVE DIALOGUE WITH MS. HOLMES?
KINGSHUK DAS: I DON'T KNOW HOW TO DESCRIBE.
MR. LEACH: HOW ABOUT AFTER SOME DIALOGUE WITH MS. HOLMES?
KINGSHUK DAS: YES, SOME DIALOGUE.
MR. LEACH: IT THEN SAYS, "THE LABORATORY NOTED MULTIPLE AND RECURRENT TIME PERIODS (ACROSS ALL ANALYTES TESTED) OF ABRUPT SHIFTS IN QC TARGET MEANS." WHAT DOES THAT MEAN?
KINGSHUK DAS: PLEASE GIVE A MINUTE TO REVIEW THAT.
(PAUSE IN PROCEEDINGS.)
KINGSHUK DAS: SO THAT FIRST PART MEANS THAT THE AVERAGE VALUES OF QUALITY CONTROL, THE TARGETS THAT WE WERE TRYING TO REACH, OR THAT THE LABORATORY WAS TARGETING, WERE BEING SHIFTED UNEXPLAINEDLY.
BY MR. LEACH:
MR. LEACH: "HIGH RATES OF 1-2S QC RULE FAILURES." WHAT IS MEANT BY "1-2S"?
KINGSHUK DAS: SO THIS 1-2S ACTUALLY REFERS TO THE SAME QC RULE FAILURES THAT THE CMS INSPECTORS WERE NOTING IN THAT D TAG. I BELIEVE IT WAS 5791, I BELIEVE. SO THEY CALL IT A --
MR. LEACH: AND THE 1-2S, THAT'S STANDARD DEVIATIONS?
KINGSHUK DAS: YES. SO THE 2S REFERS TO 2 SD ANALOGOUS TO WHAT IS BEING REFERRED TO IN THE D TAG.
MR. LEACH: AND "QC CV'S FAR EXCEEDING LIMITS FOR A STABLE TESTING PROCESS." WHAT DID THAT MEAN?
KINGSHUK DAS: TO SIMPLIFY THAT ONE A BIT, IT JUST MEANS THAT THERE WAS A LOT OF IMPRECISION NOTED.
MR. LEACH: AND IS IMPRECISION DESIRABLE OR UNDESIRABLE?
KINGSHUK DAS: UNDESIRABLE.
MR. LEACH: LET'S ZOOM OUT, MS. HOLLIMAN, AND LOOK AT THE NEXT TWO PARAGRAPHS IN THIS PATIENT IMPACT ASSESSMENT. DO YOU SEE WHERE IT SAYS PATIENT IMPACT, DR. DAS?
KINGSHUK DAS: YES, I DO.
MR. LEACH: AND THIS READS, "ALTHOUGH THE MAGNITUDE OF QC DEVIATIONS FROM TARGET MEANS DOES NOT NECESSARILY REFLECT THE EXACT NATURE AND MAGNITUDE OF BIAS ON PATIENT RESULTS BECAUSE OF DIFFERENCES IN MATRICES, THE QC FAILURES IDENTIFIED BY THIS COMPREHENSIVE RETROSPECTIVE ANALYSIS REFLECT A GLOBAL AND LONG-TERM FAILURE OF THE QUALITY CONTROL PROGRAM FOR THIS INSTRUMENT, AS WELL AS FAILURES OF RELATED QUALITY ASSURANCE PROCEDURES THAT SHOULD HAVE ALERTED THE LABORATORY TO CORRECT SUCH AN UNSTABLE PROCESS." WHY DID YOU INCLUDE THIS IN THE PATIENT IMPACT PORTION OF THIS?
KINGSHUK DAS: FIRST OF ALL, THAT'S QUITE A MOUTHFUL.
MR. LEACH: YES.
KINGSHUK DAS: THIS WAS JUST TO DESCRIBE OUR FINDINGS.
MR. LEACH: AND "THE LABORATORY HAS CONCLUDED THAT THERE IS A POSSIBLE PATIENT IMPACT FOR EVERY TEST REPORTED FROM THE LABORATORY'S TPS 3.5 INSTRUMENTS." IS THAT WHAT YOU COMMUNICATED TO CMS?
KINGSHUK DAS: YES, I BELIEVE SO.
MR. LEACH: AND WAS THAT YOUR VIEW AT THE TIME?
KINGSHUK DAS: YES, IT WAS.
MR. LEACH: IN CORRECTIVE ACTION IT READS, "THE FRACTION OF PATIENT RESULTS TRULY IMPACTED, AND THE NATURE AND MAGNITUDE OF ANY EFFECT ARE UNKNOWN. OUT OF AN ABUNDANCE OF CAUTION, THE LABORATORY HAS VOIDED ALL PATIENT TEST RESULTS REPORTED FROM THE TPS 3.5 INSTRUMENTS." DO YOU SEE THAT?
KINGSHUK DAS: I DO SEE THAT.
MR. LEACH: OKAY. AND DID YOU, IN FACT, VOID ALL OF THE TEST RESULTS FROM THE EDISON DEVICE FROM THE 2014, 2015 TIME PERIOD?
KINGSHUK DAS: YES, WE DID SO.
MR. LEACH: OKAY. AND THEN IT SAYS, "MANY CORRECTED REPORTS HAVE BEEN TRANSMITTED AND THE REMAINDER ARE BEING TRANSMITTED. TRANSMISSION WILL BE COMPLETE BY MARCH 31ST, 2016." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES, I DO.
MR. LEACH: DID YOU HAVE DISCUSSIONS WITH MS. HOLMES ABOUT HOW TO COMMUNICATE THE VOIDING OF THE TESTS TO CMS AND OTHER CONSTITUENCIES?
KINGSHUK DAS: COULD YOU BE MORE SPECIFIC.
MR. LEACH: DID YOU HAVE CONVERSATIONS WITH MS. HOLMES ABOUT HOW TO COMMUNICATE THERANOS'S VOIDING OF THE TESTS?
KINGSHUK DAS: YES, WE DID.
MR. LEACH: DESCRIBE THE SUBSTANCE OF WHAT WAS SAID?
KINGSHUK DAS: I DESCRIBED OUR RATIONALE FOR VOIDING THESE TESTS WHICH RELIED ON SOME OF THE THINGS THAT WE DISCUSSED EARLIER, WHICH WAS THE VALIDATION DATA AS WELL AS THE QC DATA THAT IS REFERENCED HERE, AS WELL AS THE PATIENT TEST RESULTS THAT WERE REFERENCED HERE, AND IT WAS -- I CAN'T REMEMBER ALL OF THE CONSTITUENTS AT THAT MEETING, BUT I TRIED TO PRESENT IT IN A MORE UNDERSTANDABLE FORMAT. SO I DESCRIBED THE ISSUE IN TERMS OF THE VALIDATION DATA IN DESCRIBING THAT THESE INSTRUMENTS APPARENTLY WERE NOT PERFORMING FROM THE VERY BEGINNING.
MR. LEACH: AND DID MS. HOLMES MAKE ANY STATEMENTS TO YOU ABOUT WHETHER WHAT YOU JUST SAID SHOULD BE COMMUNICATED TO CMS OR WHETHER SOMETHING ELSE SHOULD BE COMMUNICATED?
KINGSHUK DAS: YES. I RECALL HER OFFERING AN ALTERNATIVE EXPLANATION.
MR. LEACH: TELL US ABOUT THAT, PLEASE.
KINGSHUK DAS: I DON'T REMEMBER THE EXACT WORDS, BUT SHE POINTED TO ONE OF HER DEPUTIES AND PROVIDED AN ALTERNATIVE EXPLANATION, WHICH WAS ALONG THE LINES OF IT NOT BEING AN INSTRUMENT FAILURE PER SE BUT RATHER THE, QUOTE, "A FAILURE OF THE QUALITY CONTROL AND QUALITY ASSURANCE PROGRAM AROUND IT."
MR. LEACH: AND DID YOU THINK IT WAS A COMPLETE EXPLANATION TO DESCRIBE IT AS JUST A QUALITY CONTROL ISSUE?
KINGSHUK DAS: NO, SIR.
MR. LEACH: HOW COME?
KINGSHUK DAS: BECAUSE THE VALIDATION DATA HAD NO BEARING ON THE QUALITY CONTROL OR QUALITY ASSURANCE PROGRAM.
MR. LEACH: AFTER THE TESTS WERE VOIDED, DR. DAS, DID THERANOS EVER RESUME TESTING ON THE 3.5 DEVICE IN THE CLIA?
JUDGE DAVILA: I'M SORRY.
KINGSHUK DAS: COULD YOU REPEAT THE QUESTION, PLEASE.
BY MR. LEACH:
MR. LEACH: AFTER THE VOIDING OF THE TESTS AT SOME POINT IN MARCH OR APRIL OF 2016, DID THERANOS EVER RESUME TESTING ON THE 3.5 IN THE CLIA LAB?
KINGSHUK DAS: NO, NOT TO MY KNOWLEDGE.
MR. LEACH: OKAY. DID YOU EVER RECOMMEND THAT TESTING BE RESUMED IN THE CLIA LAB?
KINGSHUK DAS: NO.
MR. LEACH: AND WHY WAS THAT?
KINGSHUK DAS: I FOUND THESE INSTRUMENTS TO BE UNSUITABLE FOR CLINICAL USE.
MR. LEACH: YOUR HONOR, I NOTE THE TIME. THERE'S SOME ADDITIONAL PORTIONS OF THE CMS REPORT THAT I WANT TO GO THROUGH, BUT I THINK I MAY BENEFIT FROM A BREAK TO WORK THROUGH SOME OF THE REDACTIONS, AND THEN I THINK I'LL TENDER THE WITNESS.
JUDGE DAVILA: ALL RIGHT. LET'S TAKE A BREAK NOW. SHOULD WE TAKE 30 MINUTES? IS 30 MINUTES GOOD? LET'S DO THAT. WE'LL TAKE A 30 MINUTE BREAK, LADIES AND GENTLEMEN, AND THEN WE'LL FINISH OUR DAY. THANK YOU. YOU CAN STAND DOWN, SIR, AND COME BACK IN ABOUT 30 MINUTES.
KINGSHUK DAS: THANK YOU, YOUR HONOR.
JUDGE DAVILA: YOU'RE WELCOME.
(JURY OUT AT 2:42 P.M.)
JUDGE DAVILA: PLEASE BE SEATED. THANK YOU. DR. DAS, YOU CAN STAND DOWN IF YOU WOULD LIKE.
KINGSHUK DAS: THANK YOU.
COURT CLERK: YOU CAN GO OUTSIDE OF THE COURTROOM PROBABLY.
JUDGE DAVILA: ALL RIGHT. THE RECORD SHOULD REFLECT THAT OUR JURY HAS LEFT FOR OUR BREAK, AND THE WITNESS HAS LEFT THE COURTROOM. MR. LEACH, YOU WANT A BREAK TO DO SOME REDACTIONS I THINK YOU SAID?
MR. LEACH: YES, YOUR HONOR. I THINK THERE ARE TWO MORE PORTIONS OF THE REPORT THAT I'D LIKE TO ADMIT THROUGH THIS WITNESS ON THE BASIS THAT WE DISCUSSED EARLIER. I'D LIKE TO WORK THROUGH THE REDACTIONS AND THEN I WILL BE COMPLETE.
JUDGE DAVILA: ALL RIGHT. TO THE EXTENT THAT YOU FEEL COMFORTABLE, MAYBE YOU CAN SHARE THE REDACTIONS WITH MR. WADE --
MR. LEACH: YES.
JUDGE DAVILA: -- SO WE CAN TAKE CARE OF ANY OBJECTIONS OR ANYTHING IF WE CAN, IF THAT'S POSSIBLE. OKAY. THANK YOU.
MR. LEACH: THANK YOU.
MR. WADE: YOUR HONOR, IF I MIGHT BRIEFLY? I DID JUST WANT TO RAISE AND REITERATE, THE POINT THAT WE RAISED BEFORE ABOUT THE AIDING AND ABETTING LIABILITY AND WHICH IS NOWHERE AT ISSUE IN THIS CASE, AND WE RAISED IT AND SPECIFICALLY RAISED THE IDEA OF FOCUSSING ON THAT ISSUE. IT'S MY UNDERSTANDING FROM THE COLLOQUY THIS MORNING THAT MR. LEACH WAS NOT GOING TO SPECIFICALLY FOCUS ON THAT. INSTEAD, IN THE EXAMINATION HE DID EXACTLY THAT. HE WENT EXACTLY TO THAT PROVISION. HE FOCUSSED ON THAT PROVISION, WHICH IS NOT AT ISSUE, BUT CREATES THE IMPLICATION WITH THIS JURY THAT IT IS AT ISSUE. AND SO WE WOULD ASK THAT THE CURATIVE INSTRUCTION -- THAT THE INSTRUCTION THAT WE PROVIDE BE SUBMITTED AND AN INSTRUCTION BE GIVEN THAT THAT PROVISION IS NOT RELEVANT TO THIS MATTER. I UNDERSTAND THAT WE HAVE EXTENSIVELY QUESTIONED WITNESSES ON REGULATORY RESPONSIBILITIES. ALL OF THOSE REGULATORY RESPONSIBILITIES ARE RELEVANT TO THE ACTIONS IN THE CASE. FOCUSSING ON THAT PROVISION AND CREATING THE IMPRESSION THAT THERE IS SOME LIABILITY ON THE PART OF THE OWNER FOR AIDING AND ABETTING A CLIA VIOLATION WHEN THAT IS NOT AN ISSUE IN THIS CASE IS INCREDIBLY PREJUDICIAL. SO WE --
JUDGE DAVILA: I APPRECIATE THAT, AND WE DID DISCUSS THIS. THIS DOCUMENT WAS PUT IN EVIDENCE, I THINK BY THE DEFENSE, AND AS I INDICATED, IT'S FAIR GAME TO EXAMINE ON WHAT IT IS. I THINK WHAT WE TALKED ABOUT THIS MORNING WAS THE GOVERNMENT WOULD NOT BE PERMITTED TO ARGUE TO THE JURY IN ANY WAY THAT THIS IS AN AIDING AND ABETTING CASE BASED ON A REGULATORY SCHEME. MR. LEACH?
MR. LEACH: THAT IS CORRECT, YOUR HONOR, AND I DID NOT ARGUE THAT. I DREW ATTENTION TO THE PROVISION. BUT I IN NO WAY SUGGESTED THAT MS. HOLMES AIDED AND ABETTED A CLIA VIOLATION. I WAS BRINGING SOMETHING TO THE JURY'S ATTENTION THAT IS IN EVIDENCE THAT IS A POSSIBLE CONSEQUENCE AFFECTING OWNERS AND OPERATORS OF ALL LABORATORIES, AND I DON'T THINK THERE WAS ANYTHING INAPPROPRIATE WITH THE GOVERNMENT'S EXAMINATION ON THAT POINT.
JUDGE DAVILA: I THINK THAT -- AND I UNDERSTAND YOUR CONCERN, THE DEFENSE CONCERN ABOUT THAT. MY SENSE IS I WILL -- AND YOU'LL DRAFT IF YOU HAVEN'T ALREADY. YOU SUBMITTED SOMETHING, BUT I DON'T THINK THAT'S APPROPRIATE TO GIVE THAT NOW. I THINK IT'S APPROPRIATE TO GIVE IT WITH FINAL INSTRUCTIONS. I THINK IF I GIVE AN INSTRUCTION NOW, IT WILL ONLY HIGHLIGHT IT.
MR. WADE: I'M OKAY WITH HIGHLIGHTING THIS ISSUE, YOUR HONOR, BECAUSE I THINK IT CREATES -- THE IMPRESSION IS RIPE IN THE AIR. I UNDERSTAND THERE'S EVIDENCE IN THE CASE, BUT THERE'S QUESTIONING OVER OBJECTION ABOUT A PROVISION THAT IS NOT RELEVANT IN THE CASE AND FOCUSSING -- THERE'S NO EVIDENTIARY VALUE IN DOING THAT, AND THERE'S A HIGH DEGREE OF PREJUDICE. SO WE WOULD AGAIN REQUEST THAT THE INSTRUCTION BE GIVEN. WE THINK IT'S BEEN PUT BEFORE THE JURY IN A WAY THAT WAS INCONSISTENT WITH WHAT COUNSEL HAD REPRESENTED WOULD BE DONE, AND WE THINK IT'S INCREDIBLY PREJUDICIAL. SO WE THINK THE ONLY REMEDY FOR US AT THIS POINT IS TO GIVE THE INSTRUCTION NOW TO MAKE SURE WE AVOID THAT CONFUSION.
JUDGE DAVILA: WELL, THANK YOU FOR THAT. I DID -- PART OF OUR COLLOQUY THIS MORNING WAS THAT I RECOGNIZED THE CROSS-EXAMINATION OF THE TWO PREVIOUS LAB DIRECTORS AND THERE WAS EXTENSIVE AND MULTIPLE QUESTIONS POSED TO THOSE DIRECTORS REGARDING YOU'RE RESPONSIBLE, YOU'RE RESPONSIBLE. AND THAT'S APPROPRIATE QUESTIONS. AND I THINK IT'S LEGALLY CORRECT, THEY WERE RESPONSIBLE. AS I OBSERVED, SHOWING WHAT WAS ALREADY IN EVIDENCE AND TALKING ABOUT THAT MIGHT EQUATE TO A BALANCING OF, WELL, THERE ARE OTHER REGULATIONS ABOUT THAT. BUT I AGREE WITH YOU, AND I THINK MR. LEACH AGREES WITH YOU AND ME, THAT THIS IS NOT GOING TO BE ARGUED AT ALL AS ANY EVIDENCE FOR CONVICTION IN THIS CASE. I DON'T THINK THAT -- AS I SAY, I DON'T THINK A JURY INSTRUCTION RIGHT NOW WILL IN ANY WAY ASSUAGE THE CONCERNS THAT YOU HAVE, BUT I THINK IT WOULD CAUSE MORE DAMAGE TO DRAW ATTENTION TO THAT. THAT'S JUST MY OPINION NOW. I JUST THINK THAT DRAWING ATTENTION TO IT NOW WILL PERHAPS CAUSE THEM TO THINK ABOUT IT IN AN UNTOWARD MANNER. MR. LEACH, DO YOU WANT TO BE HEARD ON THIS?
MR. LEACH: I DO BRIEFLY, YOUR HONOR. I DON'T MEAN TO PROLONG THIS, BUT THE FACT THAT OWNERS AND OPERATORS FACE REVOCATION OF THEIR CLIA CERTIFICATION IF AN EMPLOYEE OR ANYBODY WITHIN THE LAB VIOLATES OR AIDS AND ABETS A CLIA VIOLATION IS A MOTIVE TO MAINTAIN A GOOD LAB, AND ALSO REALLY SCARY IF YOU'RE BEING TOLD THAT YOU'RE NOT MAINTAINING A GOOD LAB. SO IT'S THE EXISTENCE OF THE REGULATION THAT IS RELEVANT. AND IT'S ALSO RELEVANT TO CONFRONT THE FALSE SUGGESTION THAT -- AND I DON'T CAST ASPERSION ON MY COLLEAGUE WITH THAT, BUT THERE IS AN IMPRESSION, THROUGH THE EXAMINATION OF DR. ROSENDORFF, THAT ONLY THE LAB DIRECTOR HAS ANY RESPONSIBILITY. SO WE ARE NOT ARGUING THAT MS. HOLMES AIDED AND ABETTED A VIOLATION. BUT WE ARE SAYING THAT THIS REGULATION EXISTS AND IT'S SOMETHING THAT OWNERS AND OPERATORS IN GENERAL ARE AFFECTED AND MOTIVATED BY, AND I THINK THAT'S FAIR.
JUDGE DAVILA: I THINK THE WAY IT WAS PRESENTED, MR. WADE, WAS THAT THE LABORATORY COULD LOSE THEIR LICENSE, AND THAT'S SOMETHING THAT COULD HAPPEN. IT, IT DIDN'T TALK ABOUT CRIMINAL LIABILITY. IT'S NOT A CRIMINAL STATUTE. IT'S A CIVIL STATUTE THAT HAS OTHER RAMIFICATIONS, AND I CONTINUE TO BE COGNIZANT OF THE FACT THAT EVIDENCE OF A VIOLATION OF A CIVIL STATUTE CANNOT AND WILL NOT BE PERMITTED TO BE ARGUED FOR A CONVICTION OF A CRIMINAL STATUTE. THAT'S INAPPROPRIATE, AND WE ALL KNOW THAT. THE STATUTE THAT WAS READ TALKS ABOUT LICENSE, THE LOSS OF A LICENSE, AND THAT -- I THINK THAT'S A DIFFERENT, A DIFFERENT FACTOR.
MR. WADE: NO. TO BE SURE, IT IS, YOUR HONOR. MY ONLY POINT IS THAT THERE'S ABSOLUTELY NO EVIDENCE OR ALLEGATION IN THIS CASE THAT MY CLIENT AIDED AND ABETTED A CLIA VIOLATION. SO BY PUTTING THAT UP THERE, THEY'RE CREATING THE IMPRESSION THAT MY CLIENT DID. THAT'S WHY I SOUGHT TO PREVENT THE ADMISSION OF IT. IT'S DIFFERENT FROM QUESTIONS TO A LABORATORY DIRECTOR ABOUT DO YOU HAVE THIS RESPONSIBILITY AND DO YOU HAVE THAT RESPONSIBILITY WITHIN THE LAB? DO THE REGULATIONS SAY YOU HAVE ULTIMATE RESPONSIBILITY? BY THE WAY, THE ANSWER TO ALMOST ALL OF THOSE QUESTIONS WAS YES, AND IT WAS RELEVANT BECAUSE THOSE ARE THE ONES WHO ARE DISPATCHING THE OBLIGATIONS WITHIN THE LABORATORY. OUR -- MY CLIENT DOESN'T HAVE THE SAME RESPONSIBILITY. IF ANYTHING, SHE'S EFFECTIVELY STRICTLY LIABLE WITHIN THE REGULATORY SCHEME FOR THE ACTIONS OF OTHERS. SO THEY'RE NOT REALLY ANALOGOUS IN THE SENSE THAT SHE DOESN'T HAVE THAT -- HER RESPONSIBILITY IS TO HIRE A LAB DIRECTOR -- OR THE COMPANY'S RESPONSIBILITY IS TO HIRE A LAB DIRECTOR, AND THEN IT'S THE LAB DIRECTOR'S RESPONSIBILITY TO DISPENSE THOSE OBLIGATIONS. SO I THINK IT'S A FALSE COMPARISON. AND TO CREATE THE IMPRESSION WITH THIS JURY THAT THERE'S SOME AIDING AND ABETTING I THINK IS INCREDIBLY PREJUDICIAL.
JUDGE DAVILA: I UNDERSTAND THAT. AND I RECALL ONE OF THE LAST QUESTIONS THAT YOU ASKED DR. ROSENDORFF WAS ABOUT HIS ISSUES SUBSEQUENT TO EMPLOYMENT AT THE COMPANY AND THE FACT THAT HE WAS -- POTENTIALLY ONE OF THE RAMIFICATIONS OF THAT CONDUCT COULD BE THE LOSS OF A LICENSE. I THINK THAT'S WHAT YOU ASKED HIM AT THE LAST PART, RIGHT. AND SO --
JUDGE DAVILA: RIGHT. RIGHT. BUT THE LOSS OF A LICENSE IS A BIG THING FOR A LAB DIRECTOR. I THINK WE CAN ALL AGREE WITH THAT. THIS IS THE REGULATION, ONE OF THE REGULATIONS THAT POINTS TO THAT. BUT I TAKE YOUR POINT. I DON'T THINK IT'S NECESSARY TO GIVE THE INSTRUCTION NOW. MY SENSE IS THAT WE STILL HAVE A LOT OF EVIDENCE TO GO. I KNOW THE JURY IS TAKING NOTES. THEY'RE BEING ATTENTIVE OF THIS. BUT THIS IS NOT GOING TO BE ARGUED IN ANY WAY, BE PERMITTED TO BE ARGUED WHY THE GOVERNMENT FEELS IN THEIR CLOSING ARGUMENT THAT THE JURY SHOULD REACH A CONVICTION AT ALL. AND IF YOU WANT TO PREPARE AN INSTRUCTION FOR FINAL INSTRUCTIONS, I'LL LOOK AT IT. I INTEND TO GIVE ONE THAT IS PROPHYLACTIC TO THAT EXTENT, MR. LEACH. AND YOUR TEAM CAN PUT SOMETHING TOGETHER, TOO, IF YOU WOULD LIKE, BUT THERE WILL BE AN INSTRUCTION THAT TALKS ABOUT THIS, ASSUMING YOU WANT IT TO BE GIVEN AT THAT POINT. SO WE'LL TALK ABOUT IT THEN.
MR. LEACH: THANK YOU, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU.
(RECESS FROM 2:53 P.M. UNTIL 3:22 P.M.)
(JURY IN AT 3:22 P.M.)
JUDGE DAVILA: THANK YOU. WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. MS. HOLMES IS PRESENT. DR. DAS IS ON THE STAND. MR. LEACH?
MR. LEACH: THANK YOU, YOUR HONOR.
MR. LEACH: GOOD AFTERNOON, DR. DAS. I'D LIKE TO GO BACK TO EXHIBIT 4621, AND I THINK WE'RE NOW PREPARED TO DISPLAY THE PORTIONS OF 51, 52, 53, AND 54 THAT WERE ADMITTED BUT WE WERE UNABLE TO REDACT IN THE MOMENT.
JUDGE DAVILA: OH MY GOSH. DOES IT HAVE TO WARM UP?
MR. LEACH: IT WAS TIRED.
JUDGE DAVILA: I'LL SPARE COMMENT. IT HAS TO WARM UP, DOES IT? AH. THERE WE GO.
MR. LEACH: I BELIEVE WE'RE ONLY SHOWING THE BOTTOM PORTION, THE D TAG 5791 AT THE BOTTOM OF THE PAGE.
JUDGE DAVILA: AND COULD YOU IDENTIFY JUST FOR THE RECORD THIS PAGE, PLEASE, MR. LEACH?
MR. LEACH: I WILL, YOUR HONOR. YES, YOUR HONOR. WE'RE LOOKING AT PAGE 51 OF EXHIBIT 4621. DOWN AT THE BOTTOM OF THE PAGE TO THE LEFT THERE'S AN I.D. PREFIX TAG D5791.
MR. LEACH: DO YOU SEE THAT, DR. DAS?
KINGSHUK DAS: I DO.
MR. LEACH: AND JUST TO ORIENT US, TO THE RIGHT IS THERE A CODE SECTION WITHIN CLIA?
KINGSHUK DAS: YES.
MR. LEACH: THAT'S 493.1289. THAT'S ONE OF THE REGULATIONS RELATING TO OPERATION OF THE CLIA LAB?
KINGSHUK DAS: YES.
MR. LEACH: AND THEN BENEATH THAT IN PARAGRAPH A IT SAYS, "THE LABORATORY MUST ESTABLISH AND FOLLOW WRITTEN POLICIES AND PROCEDURES FOR AN ONGOING MECHANISM TO MONITOR, ASSESS, AND WHEN INDICATED, CORRECT PROBLEMS IDENTIFIED IN THE ANALYTIC SYSTEMS SPECIFIED." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES.
MR. LEACH: AND IS THAT ESSENTIALLY SPELLING OUT THE CLIA REQUIREMENT?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND IF WE CAN GO TO PAGE 52, MS. HOLLIMAN, I THINK ONLY THE TOP PORTION GOING -- THERE WE GO. IF WE COULD HIGHLIGHT THE TOP PORTION OF THIS PAGE. DR. DAS, DO YOU SEE THE REGULATORY REQUIREMENT CONTINUES IN COLUMN 2 BENEATH THE WORDS "CONTINUED FROM PAGE 47"?
KINGSHUK DAS: YES.
MR. LEACH: IS THAT HOW YOU READ THIS DOCUMENT?
KINGSHUK DAS: YES.
MR. LEACH: AND THEN IT SAYS, "THIS STANDARD IS NOT MET AS EVIDENCED BY." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES.
MR. LEACH: AND IS STANDARD A TERM OF ART IN THE CLIA REGULATIONS?
KINGSHUK DAS: YES.
MR. LEACH: AND HOW DOES A STANDARD COMPARE TO A CONDITION?
KINGSHUK DAS: I BELIEVE IT IS LESS SEVERE.
MR. LEACH: THEN DOES THE FORMAT OF THE 2567 LAY OUT PARTICULAR FINDINGS BY CMS AS TO HOW, IN CMS'S VIEW, THAT STANDARD WAS NOT MET?
KINGSHUK DAS: YES.
MR. LEACH: AND THAT'S WHAT YOU'RE TRYING TO RESPOND TO IN THE COURSE OF YOUR WORK?
KINGSHUK DAS: YES.
MR. LEACH: IF WE CAN GO TO PAGE 53, DO YOU SEE THE FINDING AT THE BOTTOM, "BASED ON REVIEW OF QUALITY CONTROL DATA AND MONTHLY QC REPORTS, THE LABORATORY FAILED TO HAVE A QUALITY ASSESSMENT PROCEDURE TO IDENTIFY AND CORRECT PROBLEMS WITH QC VALUES FOR THE THERANOS PROPRIETARY SYSTEM (TPS) WHEN PRECISION DID NOT MEET THE LABORATORY'S REQUIREMENT FOR PRECISION." DO YOU SEE THAT?
KINGSHUK DAS: YES.
MR. LEACH: AND IS PRECISION A TERM THAT YOU'RE FAMILIAR WITH IN YOUR WORK AS THE LAB DIRECTOR?
KINGSHUK DAS: YES.
MR. LEACH: AND WHAT IS PRECISION?
KINGSHUK DAS: IT'S A MEASURE OF THE SPREAD OF DATA.
MR. LEACH: AND IN THE COURSE OF RESPONDING TO THE 2567, DID YOU REVIEW A BROAD RANGE OF PRECISION DATA?
KINGSHUK DAS: YES.
MR. LEACH: LET'S GO TO PAGE 54, AND IF WE COULD ZOOM IN, MS. HOLLIMAN, ON THE TAGS DOWN TO D. DO YOU SEE IN B, DR. DAS, WHERE IT SAYS, "QC RESULTS WERE REVIEWED FROM JUNE 2014 THROUGH NOVEMBER 2014 AND JANUARY THROUGH FEBRUARY 2015 FOR VITAMIN B12, VITAMIN D, AND SEX HORMONE BINDING GLOBULIN WHICH WERE USED FOR PATIENT TESTING ON THE TPS DEVICES." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES.
MR. LEACH: AND IS THIS ALSO DATA THAT YOU REVIEWED IN THE COURSE OF YOUR WORK?
KINGSHUK DAS: YES.
MR. LEACH: IN C IT SAYS, "VITAMIN B12 QC LEVEL 1 AND LEVEL 3 ON DEVICE E 110 REVEALED THE FOLLOWING PERCENT CV: 34.3 PERCENT AND 48.5 PERCENT RESPECTIVELY FROM JANUARY 5TH, '15 THROUGH 1-30-15." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES.
MR. LEACH: AND THE DEVICE E 110, DID YOU UNDERSTAND THAT TO REFER TO A PARTICULAR EDISON DEVICE WITHIN THE LAB? DID YOU UNDERSTAND THAT TO REFER TO A DEVICE WITHIN THE LAB?
KINGSHUK DAS: YES.
MR. LEACH: AND THE QC LEVEL 1 AND LEVEL 3, WHAT DID YOU UNDERSTAND THOSE TO REFER TO?
KINGSHUK DAS: THOSE ARE DIFFERENT LEVELS OF THE RESPECTIVE TEST QC, IN THIS CASE VITAMIN B12.
MR. LEACH: AND CAN YOU -- AND WHAT IS THE PURPOSE OF DIFFERENT LEVELS?
KINGSHUK DAS: A LABORATORY IS REQUIRED TO RUN MULTIPLE LEVELS FOR EVERY QUANTITATIVE TEST, SO --
MR. LEACH: SO A HIGH LEVEL, A LOW LEVEL, SOMETHING IN BETWEEN?
KINGSHUK DAS: CORRECT.
MR. LEACH: OKAY. AND THIS SAYS THE QC LEVEL 1 AND 3 WERE 34.3 AND 48.5 PERCENT. WHAT WAS -- WHAT DID YOU UNDERSTAND THAT TO MEAN?
KINGSHUK DAS: IT APPEARS THEY'RE REFERENCING THOSE PARTICULAR LEVELS FOR THOSE QC.
MR. LEACH: AND ARE THESE DESIRABLE LEVELS OF QC OR UNDESIRABLE LEVELS OF QC?
KINGSHUK DAS: THOSE WOULD BE UNDESIRABLE.
MR. LEACH: AND IS THIS SOMETHING THAT YOU LOOKED INTO AS THE LABORATORY DIRECTOR?
KINGSHUK DAS: YES.
MR. LEACH: AND IF WE COULD ZOOM IN. IN D THERE'S SOME REFERENCE TO VITAMIN B12, QC1, AND QC3 ON DEVICE E 1085. IS THIS SIMILAR INFORMATION RELATING TO A DIFFERENT EDISON DEVICE THAT WAS BEING USED IN THE CLIA LAB?
KINGSHUK DAS: YES.
MR. LEACH: AND IS THAT SOMETHING THAT YOU INVESTIGATED?
KINGSHUK DAS: YES.
MR. LEACH: IF WE CAN ZOOM OUT, MS. HOLLIMAN, AND LOOK AT E THROUGH L, OR E THROUGH LITTLE I. DR. DAS, DID YOU UNDERSTAND THESE TO BE ADDITIONAL EXAMPLES OF HIGH CV IN QC TESTING ON DEVICES WITHIN THE CLIA LAB?
KINGSHUK DAS: YES.
MR. LEACH: AND SIMILAR TO WHAT WE LOOKED AT BEFORE, ARE THESE ISSUES THAT YOU INVESTIGATED AS PART OF YOUR WORK?
KINGSHUK DAS: YES.
MR. LEACH: AND AT ANY POINT IN TIME, DID YOU DISAGREE WITH WHAT CMS WAS FINDING HERE?
KINGSHUK DAS: NO.
MR. LEACH: LET ME DRAW YOUR ATTENTION TO -- YOU CAN TAKE THAT DOWN, MS. HOLLIMAN. LET ME DRAW YOUR ATTENTION, PLEASE, TO PAGE 40 OF EXHIBIT 4621. DO YOU HAVE THAT IN FRONT OF YOU, SIR?
KINGSHUK DAS: I DO.
MR. LEACH: OKAY. AND DO YOU SEE A D TAG, D5481?
KINGSHUK DAS: YES.
MR. LEACH: AND DOES THIS D TAG RELATE TO CONTROL PROCEDURES?
KINGSHUK DAS: YES.
MR. LEACH: INCLUDING CONTROL PROCEDURES FOR EDISON DEVICES AND ASSAY PT INR?
KINGSHUK DAS: YES.
MR. LEACH: YOUR HONOR, I OFFER -- AND I'VE PROVIDED THESE REDACTIONS TO MR. WADE, BUT AT THIS POINT I'M OFFERING EVERYTHING ON PAGE 40 FROM THE D TAG 5481 DOWN THROUGH PAGE 47, WITH A REDACTION ON PAGE 45 BEGINNING WITH PARAGRAPH 1 IN THE SECOND COLUMN FROM THE LEFT, AND WITH ANOTHER REDACTION ON PAGE 46 WITH THE PARAGRAPH FOR B. AND I'VE PROVIDED THESE TO THE DEFENSE.
JUDGE DAVILA: CAN YOU LAY A FOUNDATION, MR. LEACH?
MR. LEACH: YES.
JUDGE DAVILA: EXCUSE ME. IS THAT YOUR -- OTHER THAN THAT, THAT'S YOUR ONLY OBJECTION, WHICH IS TO SAY THAT YOU AGREE WITH THE REDACTIONS?
MR. WADE: I UNDERSTAND THE REDACTIONS. I MAY HAVE AN OBJECTION. BUT I'M JUST TRYING TO UNDERSTAND THE FOUNDATION AND THE PURPOSE FOR WHICH THEY'RE OFFERED.
JUDGE DAVILA: THANK YOU.
MR. LEACH: I'LL LAY MORE FOUNDATION, YOUR HONOR.
MR. LEACH: DR. DAS, IF YOU COULD JUST LOOK BRIEFLY AT PARAGRAPH 1 ON PAGE 40, IS THERE A REFERENCE TO QC FOR AN ASSAY CALLED PT INR?
KINGSHUK DAS: YES.
MR. LEACH: AND WAS PT INR ONE OF THE TESTS THAT THERANOS VOIDED?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU HAVE DISCUSSIONS WITH MS. HOLMES ABOUT THE PT INR ASSAY AND HOW IT WAS RUN AT THERANOS?
KINGSHUK DAS: YES.
MR. LEACH: IF I DRAW YOUR ATTENTION TO PAGE 41, DO YOU SEE TOWARDS THE BOTTOM IN PARAGRAPH 2 THERE BEGINS A DISCUSSION RELATING TO QC AND VARIOUS ASSAYS ON THE EDISON DEVICE?
KINGSHUK DAS: YES.
MR. LEACH: AND DOES THAT CONTINUE TO PAGE 45?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU DISCUSS WITH MS. HOLMES QC ISSUES RELATED TO THE EDISON DEVICE DURING THE TIME PERIOD BEFORE YOU BECAME THE LAB DIRECTOR?
KINGSHUK DAS: YES.
MR. LEACH: AND DID THERANOS ULTIMATELY VOID ALL OF THE TESTS ON THE EDISON DEVICE?
KINGSHUK DAS: YES.
MR. LEACH: AND IF YOU CONTINUE ON PAGE 45, THERE'S A D TAG, D575 COMPARISON OF TEST RESULTS. DO YOU SEE THAT?
KINGSHUK DAS: MR. LEACH, DO YOU MEAN D5775?
MR. LEACH: I DO. THANK YOU. AND DO YOU SEE THAT DISCUSSION CONTINUES ON TO PAGE 46 AND 47 WITH PARTICULAR REFERENCE TO THE EDISON DEVICE?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU HAVE DISCUSSIONS WITH MS. HOLMES ABOUT STUDIES THAT THERANOS HAD PREPARED RELATING TO THE EDISON DEVICE?
KINGSHUK DAS: YES.
MR. LEACH: YOUR HONOR, I OFFER THESE PAGES AS I'VE DESCRIBED AS EVIDENCE OF STATE OF MIND.
MR. WADE: SAME OBJECTIONS AS PREVIOUSLY NOTED. AND I TAKE IT STATE OF MIND AS OF THIS TIME PERIOD.
JUDGE DAVILA: YES.
JUDGE DAVILA: IS THAT RIGHT, MR. LEACH?
MR. LEACH: YES.
JUDGE DAVILA: ALL RIGHT. THANK YOU. THE OBJECTION IS OVERRULED. LADIES AND GENTLEMEN, THESE WILL BE ADMITTED NOT FOR THE TRUTH OF THE MATTER ASSERTED IN THE DOCUMENTS, BUT RATHER TO SHOW EVIDENCE OF THE STATE OF MIND AS TO INTENT, KNOWLEDGE. IS THAT CORRECT, MR. LEACH, INTENT AND KNOWLEDGE --
MR. LEACH: YES, YOUR HONOR.
JUDGE DAVILA: -- AS TO MS. HOLMES. IT'S OFFERED FOR THAT PURPOSE ONLY.
(GOVERNMENT'S EXHIBIT 4621, AS REDACTED, WAS RECEIVED IN EVIDENCE.)
BY MR. LEACH:
MR. LEACH: AND MS. HOLLIMAN, IF WE CAN NOW PLEASE DISPLAY PAGE 40 AS REDACTED. DR. DAS, DO YOU SEE IN THE LEFT THERE'S THE NUMBER D5481?
KINGSHUK DAS: YES.
MR. LEACH: IS THAT A REFERENCE TO THE D TAG FOR THIS IDENTIFIED DEFICIENCY?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND IS THERE A RESTATEMENT OF THE REGULATORY PROVISION IN THE COLUMN TO THE RIGHT BRIEFLY IN F AND G?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND THEN IT SAYS, "THIS STANDARD IS NOT MET AS EVIDENCED BY." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES.
MR. LEACH: AND THEN DOES CMS LIST THE PARTICULAR FINDINGS AND EVIDENCE THAT RELATE TO THIS PARTICULAR STANDARD?
KINGSHUK DAS: YES.
MR. LEACH: OKAY. AND THIS RELATES TO QC FOR SOMETHING CALLED PT INR. WHAT IS PT INR?
KINGSHUK DAS: IT IS A BLOOD CLOTTING TEST.
MR. LEACH: AND DID -- IN RESPONSE TO THE 2567, DID YOU ULTIMATELY DETERMINE TO -- THAT THERE WERE ERRORS IN THE PT INR TEST?
KINGSHUK DAS: YES.
MR. LEACH: AND DESCRIBE THOSE FOR US, PLEASE.
KINGSHUK DAS: YES. THERE WERE ACTUALLY A VARIETY OF FINDINGS. ONE OF THEM WAS ERRORS IN THE CALCULATION OF THE VALUES THAT HAS TO DO WITH EACH LOT THAT IS USED FOR THIS ASSAY ON THE SIEMENS INSTRUMENT. THERE WERE ALSO DEVIATIONS IN THE PATIENT TEST RESULT DISTRIBUTIONS, AS WELL AS QUALITY CONTROL ISSUES.
MR. LEACH: AND DID --
JUDGE DAVILA: I'M GOING TO SUSTAIN THE OBJECTION. AND THAT LAST PORTION IS STRICKEN, LADIES AND GENTLEMEN.
BY MR. LEACH:
MR. LEACH: DID YOU -- IN COMMUNICATING TO CMS, DID YOU DESCRIBE THE BASES -- DID YOU TELL CMS THAT THERANOS WAS VOIDING PT INR TESTS?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU EXPLAIN TO THEM WHY THERANOS WAS DOING THAT?
KINGSHUK DAS: YES.
MR. LEACH: WHAT DID YOU TELL CMS?
KINGSHUK DAS: I DO NOT RECALL THE EXACT LANGUAGE, BUT IT REFLECTED THE INACCURATE CALCULATIONS, AS WELL AS QUALITY CONTROL ISSUES AND INACCURACIES REFLECTED IN THE PATIENT TEST RESULT DISTRIBUTIONS.
MR. LEACH: LET'S GO FURTHER IN TIME IN THIS DOCUMENT TO PAGE 41. IF WE CAN HIGHLIGHT D THROUGH H -- OR ACTUALLY D THROUGH I. I'M SORRY, MS. HOLLIMAN. DO YOU SEE, DR. DAS, IN D WHERE IT SAYS, "ON SEPTEMBER 7TH, 2015, CITROL 3 WAS RUN SEVEN TIMES WITHOUT OBTAINING AN ACCEPTABLE QC VALUE"?
KINGSHUK DAS: YES.
MR. LEACH: AND FURTHER DOWN IN I, IT SAYS, "81 PATIENTS WERE REPORTED FROM APRIL 1ST, 2015 THROUGH 9/16/15." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES.
MR. LEACH: AND WHAT WAS THE THRUST OF THE DEFICIENCY AS YOU UNDERSTOOD IT THAT WAS BEING BROUGHT TO YOUR ATTENTION?
KINGSHUK DAS: WHAT IS BEING REFERENCED HERE IS THAT PATIENT RESULTS WERE RECORDED WHEN QUALITY CONTROLS WERE NOT RECORDED.
MR. LEACH: AND EXPLAIN WHY THAT'S, EXPLAIN WHY THAT'S AN ISSUE.
KINGSHUK DAS: QUALITY CONTROL MUST BE RUN DAILY WHEN PATIENT TEST RESULTS ARE BEING RUN ON ANY ASSAY.
MR. LEACH: SO IF YOU RUN QUALITY CONTROL AND YOU FAIL QUALITY CONTROL FOR WHATEVER REASON, YOU SHOULDN'T BE REPORTING A TEST?
KINGSHUK DAS: THAT'S RIGHT.
MR. LEACH: AND IS THIS LISTING EXAMPLES OF WHERE IT APPEARED THAT THERANOS WAS RUNNING TESTS AFTER NOT PASSING QUALITY CONTROL?
KINGSHUK DAS: YES.
JUDGE DAVILA: YOU CAN ASK THAT IN A DIFFERENT WAY. I'LL SUSTAIN THE OBJECTION AND STRIKE THAT ANSWER.
BY MR. LEACH:
MR. LEACH: AS PART OF YOUR WORK, DR. DAS, DID YOU INVESTIGATE WHETHER THERE WERE INSTANCES WHERE THERANOS REPORTED PATIENT RESULTS AFTER NOT PASSING QUALITY CONTROL?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU FIND EXAMPLES OF THAT RELATING TO PT INR?
KINGSHUK DAS: YES.
JUDGE DAVILA: OVERRULED.
BY MR. LEACH:
MR. LEACH: YOU FOUND EXAMPLES OF THAT?
KINGSHUK DAS: YES.
MR. LEACH: DID YOU ALSO -- LOOKING DOWN AT PARAGRAPH 2, DO YOU SEE THAT THE FINDING HERE IS BASED ON A REVIEW OF THE QUALITY CONTROL PROCEDURE, QC RECORDS, AND RAW DATA FROM PATIENT TEST RUNS AND INTERVIEW WITH THE GENERAL SUPERVISOR, THE LABORATORY FAILED TO ENSURE THAT THE QC WAS ACCEPTABLE FOR THE TPS SYSTEM, OR THERANOS PROPRIETARY SYSTEM, PRIOR TO REPORTING PATIENT TEST RESULTS. DO YOU SEE THAT?
KINGSHUK DAS: YES.
MR. LEACH: IN YOUR MIND, WAS THIS RAISING A SIMILAR ISSUE WITH THE EDISONS THAT WAS RAISED WITH RESPECT TO PT INR?
KINGSHUK DAS: YES.
JUDGE DAVILA: OVERRULED.
BY MR. LEACH:
MR. LEACH: AND DID YOU INVESTIGATE WHETHER THERE WERE INSTANCES WHERE THERANOS REPORTED PATIENT RESULTS FROM THE EDISON DEVICE AFTER FAILING QUALITY CONTROL?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU FIND INSTANCES OF THAT?
KINGSHUK DAS: YES.
MR. LEACH: MORE THAN ONE?
KINGSHUK DAS: YES.
MR. LEACH: AND WAS THAT AN ISSUE?
KINGSHUK DAS: YES.
MR. LEACH: WHY IS THAT?
KINGSHUK DAS: FOR THE REASONS I DELINEATED EARLIER. IT'S REQUIRED TO DO QUALITY CONTROL ON EVERY DAY THAT PATIENT TEST RESULTS ARE RUN.
MR. LEACH: LET ME GO, PLEASE, TO PAGE -- LET ME GO TO PAGE 42, AND I WANT TO DRAW YOUR ATTENTION TO PARAGRAPHS D THROUGH G. DO YOU SEE WHERE IT SAYS IN D, "QC RECORDS FOR SEX HORMONE BINDING GLOBULIN, SHOWED THAT ON DEVICE E 1025, QC LEVEL 2'S, 24 EXPIRATION WAS ON 8/14/14 AT 18:54 AND WAS NOT RUN AGAIN UNTIL 8/15/14. PATIENT DATA SHOWED THAT PATIENT SESSION," AND THERE'S A NUMBER, "WAS RUN ON 8/14/14 AT 19:09." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES.
MR. LEACH: AND IN YOUR MIND, DID YOU UNDERSTAND THIS -- WAS THIS CMS RAISING THE ISSUE OF THERANOS REPORTING PATIENT RESULTS FOR THIS PARTICULAR ASSAY AFTER FAILING QUALITY CONTROL?
KINGSHUK DAS: YES.
MR. LEACH: AND THAT'S AN ISSUE THAT YOU INVESTIGATED AS WELL?
KINGSHUK DAS: YES.
MR. LEACH: AND YOU FOUND INSTANCES WHERE THAT HAPPENED?
KINGSHUK DAS: YES.
MR. LEACH: LET ME DRAW YOUR ATTENTION, PLEASE, TO PAGE 43. AND I WANT TO DRAW YOUR ATTENTION TO THE FINDING L AT THE BOTTOM. DO YOU SEE WHERE IT SAYS, "QC RECORDS FOR VITAMIN B12 SHOWED THAT ON DEVICE E 37, QC1 HAD A '10X WARNING' MESSAGE"?
KINGSHUK DAS: YES.
MR. LEACH: AND WHAT IS A 10X WARNING MESSAGE?
KINGSHUK DAS: THAT IS REFERRING TO A QUALITY CONTROL FAILURE WHERE THE QUALITY CONTROL RESULTS LIE ON ONE SIDE OF THE MEAN EITHER ABOVE OR BELOW TEN TIMES CONSECUTIVELY.
MR. LEACH: AND IN THE COURSE OF YOUR WORK, DID YOU SEE INSTANCES WHERE THERANOS CONTINUED TO REPORT PATIENT RESULTS AFTER THIS 10X WARNING HAD COME UP?
KINGSHUK DAS: YES.
MR. LEACH: PLEASE LOOK AT THE NEXT PAGE, PAGE 44. AND IF I COULD FOCUS ON THE SECOND HALF BEGINNING WITH THE FINDING AT O THROUGH Q. DO YOU SEE, DR. DAS, WHERE IT SAYS, "LEVEY-JENNINGS CHARTS REVEALED THAT SHBG DEVICE E 26 QC1 HAD 13 CONSECUTIVE DAYS AND QC2 HAD 15 CONSECUTIVE DAYS THAT THE RESULTS WERE AT LEAST TWO STANDARD DEVIATIONS BELOW THE MEAN FROM SEPTEMBER 30TH, 2014, THROUGH 10/29/14." DO YOU SEE THAT LANGUAGE?
KINGSHUK DAS: YES.
MR. LEACH: DID YOU ALSO REVIEW LEVEY-JENNINGS CHARTS IN THE COURSE OF YOUR WORK IN INVESTIGATING THE 2567?
KINGSHUK DAS: YES.
MR. LEACH: AND IT'S BEEN A WHILE SINCE WE'VE HEARD THAT TERM, BUT WHAT IS A LEVEY-JENNINGS CHART?
KINGSHUK DAS: IT'S ALSO KNOWN AS A CONTROL CHART. IT'S JUST A WAY TO CHART QUALITY CONTROL VALUES OVER TIME WITH RESPECT TO THE EXPECTED MEAN AND STANDARD DEVIATIONS.
MR. LEACH: AND AT ANY POINT IN TIME DID YOU COMMUNICATE TO CMS THAT YOU DISAGREED WITH THIS FINDING?
KINGSHUK DAS: NO.
MR. LEACH: THAT WOULD BE TRUE OF THE FINDINGS IN P AND Q RELATED TO THE LEVY-JENNINGS CHARTS?
KINGSHUK DAS: YES.
MR. LEACH: WE TALKED A LITTLE BIT ABOUT -- THANK YOU, MS. HOLLIMAN. WE CAN TAKE THAT DOWN. DURING THE COURSE OF YOUR WORK, DID YOU BECOME FAMILIAR WITH THE ARIZONA LAB, THE MODERATE COMPLEXITY ARIZONA LAB?
KINGSHUK DAS: YES.
MR. LEACH: AND AS A RESULT OF YOUR WORK, THE TESTING THAT WAS DONE IN THE ARIZONA LAB WAS NOT DONE ON ANY THERANOS DEVICES; IS THAT CORRECT?
KINGSHUK DAS: YES.
MR. LEACH: AND IT WAS NOT DONE ON ANY MODIFIED THIRD PARTY DEVICES?
KINGSHUK DAS: YES.
MR. LEACH: AND DID YOU UNDERSTAND THAT THE VOLUME OF TESTING IN ARIZONA EXCEEDED THE VOLUME OF TESTING IN CALIFORNIA?
KINGSHUK DAS: YES.
MR. LEACH: BY SOME ORDER OF MAGNITUDE?
KINGSHUK DAS: COULD YOU BE MORE SPECIFIC?
MR. LEACH: BY WHAT ORDER OF MAGNITUDE APPROXIMATELY?
KINGSHUK DAS: I'M NOT AWARE OF THAT NUMBER.
MR. LEACH: OKAY. WE TALKED EARLIER ABOUT THE VOIDING OF THE TEST RESULTS FROM THE EDISON 3.5. WHAT MECHANICALLY DID YOU DO TO VOID THE RESULTS?
KINGSHUK DAS: COULD YOU SPECIFY "MECHANICALLY"?
MR. LEACH: DID THE COMPANY SEND SOMETHING TO PATIENTS? WHAT DID IT DO?
KINGSHUK DAS: AH, YES. CORRECTIVE REPORTS WERE SENT, IN THIS CASE VOIDED REPORTS.
MR. LEACH: AND DID THE CORRECTED REPORTS GIVE A PARTICULAR NUMBER OR DID IT JUST SAY VOID?
KINGSHUK DAS: EXACTLY, VOID.
MR. LEACH: APPROXIMATELY HOW MANY EDISON TESTS WERE VOIDED?
KINGSHUK DAS: I DON'T KNOW THE EXACT NUMBER, BUT IT WAS APPROXIMATELY 50- TO 60,000.
MR. LEACH: AND THAT'S THE TOTAL UNIVERSE OF TESTS THAT WERE RUN ON EDISON IN THE CLIA LAB?
KINGSHUK DAS: YES.
MR. LEACH: DID YOU EVER RESUME TESTING ON THE EDISON 3.5 IN THE CLIA LAB?
MR. LEACH: DID YOU EVER RESUME TESTING ON ANY OTHER THERANOS MANUFACTURED DEVICE IN THE CLIA LAB?
MR. LEACH: MAY I HAVE A MOMENT, YOUR HONOR?
JUDGE DAVILA: YES.
(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)
MR. LEACH: I HAVE NO FURTHER QUESTIONS, YOUR HONOR. THANK YOU. THANK YOU, DR. DAS.
JUDGE DAVILA: MR. WADE, DO YOU HAVE CROSS-EXAMINATION?
(PAUSE IN PROCEEDINGS.)
CROSS-EXAMINATION BY MR. WADE:
KINGSHUK DAS: GOOD AFTERNOON.
MR. WADE: MY NAME IS LANCE WADE. I REPRESENT ELIZABETH HOLMES, AND I'LL ASK YOU A FEW QUESTIONS ON HER BEHALF HERE THIS AFTERNOON, AND IT LOOKS LIKE PROBABLY GOING INTO TOMORROW AS WELL. OKAY?
KINGSHUK DAS: YES.
MR. WADE: OKAY. I'D LIKE TO JUST START BY ORIENTING EVERYONE TO SOME OF THE DATES HERE. MR. LEACH ASKED YOU ABOUT THE CMS INSPECTION THAT WAS REFLECTED IN THE REPORT THAT HE WAS SHOWING YOU. DO YOU RECALL THAT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND THEN THE REPORT THAT MR. LEACH SHOWED YOU WAS ISSUED TOWARDS THE END OF JANUARY; RIGHT?
KINGSHUK DAS: YES.
MR. WADE: SO THERE WAS A PERIOD OF TIME BETWEEN WHEN YOU STARTED AND WHEN YOU RECEIVED THE CMS REPORT; RIGHT?
KINGSHUK DAS: YES.
MR. WADE: AND IN THAT PERIOD OF TIME BEFORE IT EVEN GOT THE CMS REPORT, THERANOS WAS WORKING ON IMPROVING ITS LAB PRACTICES AND STRENGTHENING ITS LAB PRACTICES, WAS IT NOT?
KINGSHUK DAS: YES.
MR. WADE: AND, IN FACT, THERANOS HAD BROUGHT IN A LARGE TEAM OF PEOPLE TO WORK ON THOSE EFFORTS, HAD IT NOT?
KINGSHUK DAS: COULD YOU SPECIFY "LARGE" PLEASE.
MR. WADE: YOU RECALL -- I BELIEVE IN YOUR DIRECT TESTIMONY YOU SAID THERE WAS A BIG GROUP OF PEOPLE WHO WERE WORKING ON THESE ISSUES. DO YOU RECALL THAT?
KINGSHUK DAS: YES.
MR. WADE: AND THERE WERE ACTUALLY -- THERE ENDED UP BEING, I THINK, THREE DIFFERENT LAB DIRECTORS WHO WERE DIRECTLY INVOLVED IN IMPROVING THE LABORATORY AT THERANOS; RIGHT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND ONE OF THE THINGS THAT YOU WERE ASKED TO DO WAS TO GO TO WORK ON IMPROVING THE LAB RIGHT AWAY; RIGHT?
KINGSHUK DAS: YES.
KINGSHUK DAS: TSCHIRHART.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: OKAY. AND IN ADDITION TO THAT, THE COMPANY HAD ALSO RETAINED SOME LABORATORY CONSULTANTS TO WORK ON THOSE EFFORTS; ISN'T THAT RIGHT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND HE WAS RETAINED EVEN BEFORE YOU WERE HIRED TO WORK ON STRENGTHENING THE LAB PRACTICES; RIGHT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: PRIOR TO.
KINGSHUK DAS: YES.
MR. WADE: SHE WAS ANOTHER PERSON WHO THE COMPANY HAD HIRED TO GO TO WORK ON STRENGTHENING THE LABORATORY PRACTICES; CORRECT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND BEFORE -- ALL OF THESE PEOPLE WERE HIRED BEFORE THE CMS REPORT WAS ISSUED IN LATE JANUARY OF 2016; CORRECT?
KINGSHUK DAS: YES.
MR. WADE: AND THIS WAS ALL PART OF AN EFFORT TO TRY TO STRENGTHEN THE CLIA LAB WITHIN THERANOS; RIGHT?
KINGSHUK DAS: YES.
MR. WADE: AND JUST SO WE'RE CLEAR, THERE WERE THREE LABORATORY DIRECTORS WHO WERE WORKING ON THIS AT THE TIME THAT YOU AND DR. TSCHIRHART JOINED THE COMPANY; IS THAT RIGHT?
KINGSHUK DAS: YES.
MR. WADE: OKAY. AND THOSE THREE LABORATORY DIRECTORS CONTINUED FOR MANY MONTHS TO WORK THROUGH THIS PROBLEM; IS THAT RIGHT?
KINGSHUK DAS: COULD YOU SPECIFY THE NUMBER OF MONTHS?
KINGSHUK DAS: I DON'T REMEMBER THE EXACT NUMBER --
KINGSHUK DAS: -- OF MONTHS.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND AS THE PEOPLE WERE WORKING TO DO THIS, WAS IT YOUR OBSERVATION THAT THEY WERE -- LET ME STRIKE THAT. YOU WERE ESSENTIALLY, ONCE YOU CAME ON BOARD, YOU WERE THE CLIA DIRECTOR; RIGHT?
KINGSHUK DAS: YES.
MR. WADE: AND THERE WAS A DEGREE TO WHICH YOU WERE THE QUARTERBACK FOR THAT WHOLE EFFORT; IS THAT FAIR?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND THAT THEY WERE TRYING TO DO EVERYTHING THAT THEY COULD TO TRY TO STRENGTHEN THE LABORATORY PRACTICES AT THERANOS?
KINGSHUK DAS: YES.
MR. WADE: AND THAT AS THEY WERE WORKING TO UNDERSTAND WAYS TO IMPROVE, THEY WERE DIGGING INTO THE RELEVANT EVIDENCE AND FACTS THAT WAS NECESSARY TO THEM TO UNDERSTAND THE ISSUES. IS THAT RIGHT?
KINGSHUK DAS: YES.
MR. WADE: OKAY. AND ALL OF THE PEOPLE WHO I HAVE JUST IDENTIFIED WERE NOT PEOPLE WHO WERE PART OF THE HISTORICAL LAB OPERATIONS AT THERANOS; CORRECT?
KINGSHUK DAS: YES.
MR. WADE: AND THEY WERE ALL ESSENTIALLY OUTSIDERS WHO WERE BROUGHT IN TO WORK ON STRENGTHENING THESE LAB PRACTICES; RIGHT?
KINGSHUK DAS: YES.
MR. WADE: OKAY. AND WAS IT YOUR OBSERVATION WHEN THIS WAS HAPPENING THAT MS. HOLMES WAS SUPPORTIVE OF THOSE EFFORTS?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND INITIALLY, AGAIN, ALL OF THIS WORK STARTED BEFORE THERE WAS ANY NOTICE OF THE KIND THAT MR. LEACH WAS PUTTING UP ON THE SCREEN; RIGHT?
KINGSHUK DAS: YES.
MR. WADE: OKAY. AND IN THOSE EARLY DAYS, I TAKE IT YOU HAD TO KIND OF DIG IN A LITTLE BIT AND GET A SENSE OF WHAT -- HOW THE LAB OPERATED; IS THAT RIGHT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND YOU -- I TAKE IT YOU SAT DOWN AND YOU TALKED WITH MANY OF THE PEOPLE WHO HAD WORKED THERE HISTORICALLY ON -- IN THE LAB AND ON THE TECHNOLOGY.
KINGSHUK DAS: YES, SOME OF THOSE EMPLOYEES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: NOT AT THAT TIME.
KINGSHUK DAS: YES.
MR. WADE: OKAY. AND THIS WAS ALL IN AN EFFORT FOR YOU TO FULLY UNDERSTAND ALL OF THE RELEVANT FACTS SO THAT YOU COULD DIG IN AND WORK ON IMPROVING THE LAB PRACTICES; RIGHT?
KINGSHUK DAS: COULD YOU SPECIFY "FULLY UNDERSTAND"?
MR. WADE: WELL, YOU WANTED TO MAKE SURE THAT YOU UNDERSTOOD THE FACTS NEEDED TO STRENGTHEN THE LAB AND BE COMFORTABLE WITH HOW IT WAS OPERATING FROM A CLIA STANDPOINT; IS THAT RIGHT?
KINGSHUK DAS: YES.
MR. WADE: OKAY. AND, AND MS. HOLMES PLACED NO LIMITATIONS ON YOU WHATSOEVER IN TERMS OF WHAT YOU COULD LOOK AT; RIGHT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND THEN EVENTUALLY YOU CAME IN AND YOU WORKED FULL TIME ON TACKLING THIS PROBLEM; RIGHT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: BECAUSE YOU DISCUSSED EARLIER THAT YOU WERE UNDER A PRETTY TIGHT TIMEFRAME TO BE IN A POSITION TO RESPOND TO THESE ISSUES; RIGHT?
KINGSHUK DAS: YES.
MR. WADE: AND INITIALLY THERE WAS A DESIRE BEFORE THE CMS REPORT, THERE WAS A DESIRE THAT WAS COMMUNICATED TO STRENGTHEN THE LAB; RIGHT?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
MR. WADE: AND THEN ONCE YOU GOT TO THE POINT WHERE THERE WAS A CMS REPORT, THERE WERE ACTUALLY PRETTY FIRM DEADLINES AND A DESIRE TO DIG IN AND TACKLE THOSE ISSUES AGGRESSIVELY; RIGHT?
KINGSHUK DAS: COULD YOU SPECIFY THE DEADLINES?
MR. WADE: WELL, YOU RECALL MR. LEACH SHOWED YOU -- I THINK HE SHOWED YOU A LETTER THAT SAID THAT THERE WERE TEN DAYS TO RESPOND, OR SOMETHING TO THAT EFFECT, IN THE INITIAL -- TO THE INITIAL NOTICE. DO YOU RECALL?
KINGSHUK DAS: YES.
KINGSHUK DAS: YES.
KINGSHUK DAS: COULD YOU SPECIFY "AGGRESSIVELY"?
MR. WADE: SURE. IT WANTED TO BE RESPONSIVE TO THE ISSUES THAT WERE BEING RAISED BY CMS; IS THAT RIGHT?
KINGSHUK DAS: YES.
MR. WADE: OKAY. YOUR HONOR, THIS MIGHT BE A GOOD PLACE TO STOP. WE'RE AT 4:00 O'CLOCK. WE'LL PICK UP TOMORROW MORNING, DOCTOR. THANK YOU.
KINGSHUK DAS: THANK YOU.
JUDGE DAVILA: SO WE'LL TAKE OUR RECESS TONIGHT, LADIES AND GENTLEMEN. I HOPE WE'LL BE ABLE TO START TOMORROW MORNING AT 9:00 A.M. WE'LL SEE WHAT SURPRISES AWAIT US. I HAVE GREAT CONFIDENCE IN OUR I.T. STAFF, THAT THEY'LL BE ABLE TO RESOLVE THIS ISSUE. SO THANK YOU FOR YOUR COURTESY IN GOING THROUGH -- IT WAS A TRIP DOWN MEMORY LANE. THIS IS HOW TRIALS USED TO BE DONE YEARS AGO. BEFORE WE HAD THE COMPUTERS, WE HAD PROJECTORS AND THAT'S HOW IT WORKED, AND THOSE TRIALS WERE SUCCESSFUL. IT WORKS. SO I APOLOGIZE FOR THE DISRUPTION TODAY. I HOPE WE CAN ALLEVIATE THAT OVER THE EVENING. BUT OVER THE EVENING, PLEASE REFRAIN AND AVOID COMMUNICATING WITH ANYONE ABOUT ANYTHING ABOUT THIS CASE. DON'T DO ANY RESEARCH. DON'T MAKE ANY OPINIONS OR FORM ANY OPINIONS OR REACH ANY CONCLUSIONS YET UNTIL THE CASE HAS BEEN DELIVERED TO YOU FOR YOUR DELIBERATIONS. HAVE A GOOD EVENING. WE'LL SEE YOU TOMORROW AT 9:00 A.M. AND, DR. DAS, YOU CAN STAND DOWN. WE'LL SEE YOU TOMORROW AT 9:00 A.M.
KINGSHUK DAS: THANK YOU, YOUR HONOR.
JUDGE DAVILA: YOU'RE WELCOME.
(JURY OUT AT 4:03 P.M.)
JUDGE DAVILA: THANK YOU. PLEASE BE SEATED. THANK YOU. DOCTOR, YOU CAN STAND DOWN. THANK YOU. ALL RIGHT. THE RECORD SHOULD REFLECT THAT OUR JURY HAS LEFT FOR THE EVENING AND THE WITNESS HAS LEFT THE COURTROOM. ANYTHING FURTHER BEFORE WE BREAK, MR. LEACH AND YOUR TEAM?
MR. LEACH: NOT FROM THE GOVERNMENT, NO, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU. HAVE A GOOD EVENING. WE'LL SEE YOU TOMORROW. THANKS.
COURT CLERK: COURT IS ADJOURNED.
(COURT ADJOURNED AT 4:04 P.M.)