Mark Burnes — Direct/Cross/Redirect
629 linesDIRECT EXAMINATION BY MR. SCHENK:
MR. SCHENK: GOOD MORNING, DR. BURNES. I UNDERSTAND THAT YOU'RE GOING TO TESTIFY TODAY WITH A MASK ON. NOTICE NEXT TO THE WIPES ON THE WITNESS STAND, THERE IS A BOX WITH CLEAR MASKS. YOUR HONOR, MAY I APPROACH?
JUDGE DAVILA: YES, THANK YOU. MR. SCHENK IS GOING TO GET THAT FOR YOU. SO WE'LL ASK YOU, SIR, TO CHANGE YOUR MASK TO THIS CLEAR MASK, IF YOU WOULD, PLEASE. AND FOR THE RECORD, WE HAVE CLEAR MASKS AVAILABLE IN THE COURT HERE, AND DR. BURNES HAS AFFIXED HIS CLEAR MASK WITH THAT. MR. DOWNEY, ANY OBJECTION TO THIS?
MR. DOWNEY: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU.
MR. SCHENK: MAY I, YOUR HONOR?
JUDGE DAVILA: YES.
BY MR. SCHENK:
MR. SCHENK: DR. BURNES, WHAT TYPE OF MEDICINE DO YOU PRACTICE?
MARK BURNES: INTERNAL MEDICINE.
MR. SCHENK: AND DO YOU HAVE A PRACTICE OF YOUR OWN?
MARK BURNES: YES.
MR. SCHENK: AND WHERE IS THAT PRACTICE LOCATED?
MARK BURNES: GOODYEAR, ARIZONA.
MR. SCHENK: AND WOULD YOU BRIEFLY DESCRIBE YOUR EDUCATIONAL BACKGROUND TO THE JURY?
MARK BURNES: UNDERGRADUATE WAS ACTUALLY HERE IN SANTA CLARA. I GRADUATED IN 1978. THEN I WENT TO POST GRADUATE SCHOOL AT THE UNIVERSITY OF ARIZONA IN ABOUT THE 1984 TIMEFRAME. THEN I WENT TO ST. LOUIS UNIVERSITY IN ST. LOUIS, MISSOURI MEDICAL SCHOOL FROM 1985/'86 UNTIL I GRADUATED IN 1989. THEN RESIDENCY HERE -- NOT HERE -- IN PHOENIX, ARIZONA IN INTERNAL MEDICINE, AND COMPLETED THAT IN 1992.
MR. SCHENK: AND AFTER YOUR RESIDENCY, DID YOU OPEN YOUR PRACTICE?
MARK BURNES: YES.
MR. SCHENK: AND YOU'VE BEEN WORKING AT THAT PRACTICE EVER SINCE?
MARK BURNES: YES.
MR. SCHENK: AS PART OF YOUR PRACTICE, HAVE YOU BECOME FAMILIAR WITH A BLOOD TEST THAT IS KNOWN AS A PSA TEST?
MARK BURNES: YES.
MR. SCHENK: AND WHAT DOES PSA STAND FOR?
MARK BURNES: PROSTATE SPECIFIC ANTIGEN.
MR. SCHENK: AND WHAT DOES THE PSA TEST TEST FOR?
MARK BURNES: IT'S AN INDICATOR TO SUGGEST SUSPICION FOR POSSIBLE PROSTATE CANCER.
MR. SCHENK: IN THE COURSE OF YOUR PRACTICE, HAVE YOU HAD EXPERIENCE INTERPRETING PSA TEST RESULTS?
MARK BURNES: YES.
MR. SCHENK: AND DO YOU HAVE AN ESTIMATE OF THE NUMBER OF TIMES OR THE NUMBER OF TESTS THAT YOU'VE INTERPRETED?
MARK BURNES: OVER 10,000.
MR. SCHENK: AND YOU SAID THAT IT'S AN INDICATOR FOR THE POSSIBLE PRESENCE OF PROSTATE CANCER; IS THAT RIGHT?
MARK BURNES: YES.
MR. SCHENK: AND DO YOU HAVE AN ESTIMATE OF THE NUMBER OF PATIENTS YOU'VE TREATED FOLLOWING A POSITIVE OR A POSSIBLE INDICATION OF PROSTATE CANCER?
MARK BURNES: ROUGHLY, OVER THE LAST 30 YEARS, ABOUT 200 PATIENTS WITH PROSTATE CANCER.
MR. SCHENK: DID YOU RECEIVE TRAINING IN MEDICAL SCHOOL ON THE PSA TEST?
MARK BURNES: YES.
MR. SCHENK: AND WOULD YOU JUST BRIEFLY DESCRIBE FOR US WHAT THAT INVOLVED?
MARK BURNES: IT'S PART OF THE STANDARD COURSES TO EDUCATE YOU ON THE INTERPRETATION OF TESTS, AS WELL AS THEIR LIMITATIONS.
MR. SCHENK: YOUR HONOR, THE GOVERNMENT OFFERS DR. BURNES AS AN EXPERT IN THE AREA OF DIAGNOSING PROSTATE CANCER, THE BLOOD TEST FOR PSA, AND INTERPRETING PSA TEST RESULTS.
MS. TREFZ: NO OBJECTION, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU. THIS WITNESS MAY TESTIFY, LADIES AND GENTLEMEN, BECAUSE OF HIS BACKGROUND, EXPERIENCE, AND EDUCATION AS AN EXPERT ON THESE AREAS. YOU'LL BE INFORMED IN THE FINAL INSTRUCTIONS AS TO HOW YOU MAY TREAT THIS TESTIMONY. THANK YOU.
MR. SCHENK: THANK YOU, YOUR HONOR.
MR. SCHENK: DR. BURNES, THROUGHOUT YOUR TIME RUNNING THIS PRACTICE IN ARIZONA, DID YOU BECOME FAMILIAR WITH A BLOOD TESTING COMPANY KNOWN AS THERANOS?
MARK BURNES: YES.
MR. SCHENK: DID YOU HAVE A PATIENT BY THE NAME OF MEHRL ELLSWORTH?
MARK BURNES: YES.
MR. SCHENK: AND IS THAT M-E-R-H-L, AND THE LAST NAME E-L-L-S-W-O-R-T-H?
MARK BURNES: YES, I BELIEVE THAT'S PRETTY CLOSE. THAT'S HIS NAME.
MR. SCHENK: THANK YOU. WAS THERE A TIME WHEN YOU SUGGESTED TO -- IS IT DR. ELLSWORTH?
MARK BURNES: YES. HE'S A RETIRED DENTIST.
MR. SCHENK: WAS THERE A TIME WHEN YOU SUGGESTED TO DR. ELLSWORTH THAT HE HAVE A PSA BLOOD TEST?
MARK BURNES: IT WAS NOT MY SUGGESTION AT THAT PARTICULAR TIME. WE ROUTINELY PERFORM EXAMS SUCH AS THAT ON PHYSICALS ABOUT ONCE EVERY YEAR OR TWO. I DON'T KNOW IF YOU WANT ME TO GO INTO THE SPECIFICS OF THE LAB TESTING QUESTION, BUT IT WAS NOT -- IT WAS ORIGINATED BY HIS CHURCH ACTUALLY, THEIR REQUEST.
MR. SCHENK: I SEE. DR. ELLSWORTH'S CHURCH ASKED HIM TO GET A PSA TEST AND YOU ADVISED HIM WHERE TO GO?
MARK BURNES: YES.
MR. SCHENK: AND WHERE DID YOU ADVISE DR. ELLSWORTH TO GO FOR THE TEST?
MARK BURNES: HE WAS GOING TO BE OUT OF THE COUNTRY FOR TWO YEARS AND THEY REQUIRE IT AS PART OF THE SERVICE FOR MISSIONARY WORK TO OBTAIN THE TEST JUST BEFORE HE DEPARTED, AND IT WAS OUT OF THE NORMAL SEQUENCE, SO I SENT HIM TO THERANOS BECAUSE IT WOULD BE LESS EXPENSIVE FOR HIM TO GET THE TEST DONE.
MR. SCHENK: YOU SAID IT WAS OUT OF SEQUENCE. WHAT DO YOU MEAN BY THAT?
MARK BURNES: NORMALLY WE DO THOSE EVERY YEAR OR TWO WITH PHYSICALS. IT WAS -- BUT WE WERE DOING A SPECIFIC TEST FOR HIM AS PART OF HIS -- THAT WAS REQUIRED BY HIS MISSIONARY WORK AS I RECALL.
MR. SCHENK: YOU SAID YOU USUALLY DO "THOSE." WERE YOU REFERRING TO PSA TESTS?
MARK BURNES: YES, ALONG WITH THE OTHER TESTS WE DO ANNUALLY, OR TWICE A YEAR, OR ABOUT ONCE EVERY TWO YEARS.
MR. SCHENK: THANK YOU. YOUR HONOR, MAY I APPROACH?
JUDGE DAVILA: YES.
BY MR. SCHENK:
MR. SCHENK: (HANDING.) DR. BURNES, I'VE HANDED YOU A BINDER, AND IF YOU'LL OPEN UP THE BINDER TO THE SECOND TAB IN THE BINDER. IT'S EXHIBIT 4938. YOUR HONOR, THE GOVERNMENT OFFERS 4938 PURSUANT TO STIPULATION.
MS. TREFZ: THAT'S CORRECT, YOUR HONOR.
JUDGE DAVILA: IT'S RECEIVED, ADMITTED, AND IT MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4938 WAS RECEIVED IN EVIDENCE.)
MARK BURNES: OKAY. I'M AT THAT SECTION NOW.
JUDGE DAVILA: IT MAY BE PUBLISHED. THIS IS A MULTIPAGE DOCUMENT?
MR. SCHENK: YES, YOUR HONOR. THANK YOU. IF WE CAN START ON PAGE 7 OF THIS EXHIBIT.
MR. SCHENK: DR. BURNES, THE EXHIBIT WILL ALSO DISPLAY ON THE SCREEN IN FRONT OF YOU. IF THAT'S EASIER TO --
MARK BURNES: NO. THE LIGHTING IN HERE IS PRETTY GOOD.
MR. SCHENK: OKAY. JUST LET ME KNOW IF YOU'RE HAVING DIFFICULTY SEEING ONE OF THE TWO AND WE'LL DO WHAT WE CAN.
MARK BURNES: OKAY. I'M ON PAGE 7.
MR. SCHENK: ON PAGE 7 -- FIRST OF ALL, DO YOU RECOGNIZE THIS DOCUMENT?
MARK BURNES: YES.
MR. SCHENK: AND WHAT IS THIS?
MARK BURNES: THIS IS A LAB RESULT FROM THERANOS.
MR. SCHENK: FOR WHICH PATIENT?
MARK BURNES: ELLSWORTH, MEHRL.
MR. SCHENK: OKAY. AND ON THE VERY TOP THERE'S A FAX HEADER. DO YOU SEE THAT?
MARK BURNES: YES.
MR. SCHENK: IT SAYS MAY 16, 2015. DO YOU SEE THAT?
MARK BURNES: YES.
MR. SCHENK: IS IT YOUR ROUTINE PRACTICE AT YOUR MEDICAL PRACTICE TO RECEIVE LAB RESULTS FROM THE LAB VIA FAX?
MARK BURNES: YES.
MR. SCHENK: AND DO YOU KNOW WHETHER THIS LAB RESULT WAS FAXED TO YOUR OFFICE?
MARK BURNES: YES.
MR. SCHENK: AND YOUR LAB OFFICE WAS LOCATED IN ARIZONA; IS THAT RIGHT?
MARK BURNES: YES.
MR. SCHENK: IF WE COULD NOW GO DOWN. DO YOU SEE VISIT DATE?
MARK BURNES: I APOLOGIZE. YES, UH-HUH.
MR. SCHENK: AND WHAT IS THE VISIT DATE?
MARK BURNES: I'M SORRY, I NEED MY PHONE TO GET MY LIGHT OUT HERE.
MR. SCHENK: YOUR HONOR, I BROUGHT A FLASHLIGHT. MAY I APPROACH?
JUDGE DAVILA: YES.
BY MR. SCHENK:
MR. SCHENK: (HANDING.)
MARK BURNES: THE VISIT DATE WAS MAY 14TH, 2015.
MR. SCHENK: OKAY. AND A LITTLE BIT BELOW THAT WE SEE A TEST SCORE. IT SAYS FOR THE PROSTATE SPECIFIC ANTIGEN TOTAL, AND THEN THE RESULT. DO YOU SEE THE RESULT?
MARK BURNES: YES.
MR. SCHENK: AND WHAT IS THE RESULT?
MARK BURNES: 26.1.
MR. SCHENK: AND IN YOUR EXPERIENCE, WHAT DOES THAT MEAN? WHAT DOES THE SCORE INFORM THE PHYSICIAN WHEN THE PHYSICIAN LOOKS AT A PSA SCORE?
MARK BURNES: PART OF IT IS THE TOTAL VALUE OF IT, HOW IMPORTANT IT MIGHT BE. BUT MOSTLY WE TRACK DATA POINTS OVER TIME WITH PATIENTS, AND WHAT WE'RE LOOKING FOR IS A SIGNIFICANT RISE FROM ONE YEAR TO THE NEXT.
MR. SCHENK: EXPLAIN --
MARK BURNES: THAT WOULD INVOKE US TO LOOK AT THIS MORE CLOSELY IN THE UPCOMING YEAR.
MR. SCHENK: HELP ME TO UNDERSTAND THAT. YOU SAID SOME OF IT IS THE TOTAL SCORE AND SOME OF IT IS THE RISE?
MARK BURNES: IT HAS OCCURRED A COUPLE TIMES WHERE A BRAND NEW PATIENT HASN'T SEEN A DOCTOR FOR A NUMBER OF YEARS WOULD COME IN AND WE DRAW A TEST AND IT WOULD BE QUITE HIGH, SO I HAVE NO REFERENCE VALUE FOR THE RATE OF RISE. SO IF IT WAS IN THE NORMAL RANGE, AS ON THE SLIDE OF LESSON 4, THEN I WOULDN'T BE TOO SUSPICIOUS. IF IT WAS QUITE HIGH AND HAD NO PREVIOUS TRACKING, THEN I'M NOT SURE -- IT WOULD BE A LITTLE MORE DIFFICULT TO DECIDE WHERE TO GO FROM THERE.
MR. SCHENK: I SEE. SO YOU MIGHT NOT WANT TO LOOK AT ONE INDIVIDUAL PSA RESULT, YOU WANT TO LOOK AT A COLLECTION OF THEM OR A TREND?
MARK BURNES: THAT IS OUR PREFERENCE.
MR. SCHENK: YOU ALSO SAID SOMETHING ABOUT THE NUMBER 4. WHAT DID YOU MEAN BY THAT?
MARK BURNES: YOU'LL SEE ON THE LAB DOCUMENTS MOST LAB TESTS, STANDARD RANGE THAT IS IDENTIFIED AS NORMAL FOR A PSA IS LESS 4 AND -- OH, THEY'LL HAVE A STANDARD RANGE OF ABOUT 4-NANOGRAMS PER DECILITER. IF THE TEST IS ABOVE THAT, IF THE RESULT IS ABOVE THAT 4, IT WILL BE FLAGGED AS HIGH, BUT WE DON'T USUALLY PAY ATTENTION TO THAT. WHAT WE USUALLY PAY ATTENTION TO IS THE RATE OF RISE OVER TIME. SO A PSA WOULD NORMALLY RISE SLOWLY FOR MOST MALE PATIENTS OVER THE YEARS, AND IF WE SEE A DOUBLING AND TRIPLING, THEN THAT MAKES US LOOK INTO IT FURTHER. THAT'S HOW WE USUALLY USE IT. WE DON'T USUALLY USE AN ISOLATED NUMBER BY ITSELF.
MR. SCHENK: WHEN YOU SAW THAT DR. ELLSWORTH'S SCORE WAS A 26, DO YOU KNOW HOW THAT COMPARED TO PRIOR PSA SCORES FOR DR. ELLSWORTH?
MARK BURNES: IT WAS MARKEDLY HIGHER.
MR. SCHENK: I'M SORRY, IT WAS WHAT?
MARK BURNES: IT WAS MARKEDLY HIGHER.
MR. SCHENK: OKAY. SO USING THAT SORT OF TREND ANALYSIS THAT YOU'VE DESCRIBED TO US, WHAT INFORMATION DOES THIS SCORE THEN PROVIDE?
MARK BURNES: IT REQUIRED US TO VALIDATE IF THAT WAS A CORRECT VALUE.
MR. SCHENK: AND HOW DO YOU DO THAT?
MARK BURNES: FIRST IS SIMPLY TO REPEAT THE TEST.
MR. SCHENK: OKAY. COULD WE GO DOWN? TOWARDS THE BOTTOM OF THIS DOCUMENT THERE'S SOME HANDWRITING ON IT. DO YOU SEE THAT?
MARK BURNES: YES.
MR. SCHENK: COULD YOU READ -- FIRST, IS THAT YOUR HANDWRITING?
MARK BURNES: THE PART I WILL BE READING, YES.
MR. SCHENK: COULD YOU READ THAT?
MARK BURNES: "VERY SIGNIFICANT RISE, RECHECK, MAYBE LAB ERROR."
MR. SCHENK: AND THEN TO THE RIGHT OF THAT THERE'S A STAMP. DO YOU SEE THAT?
MARK BURNES: YES.
MR. SCHENK: AND COULD YOU EXPLAIN THE STAMP TO THE JURY?
MARK BURNES: IT'S A STANDARD STAMP THAT WE USE WHEN WE RECEIVE OUTSIDE LAB RESULTS. THE FIRST PART IS INITIALLED BY THE MEDICAL ASSISTANT USUALLY WHO INITIALS IT AND THE DATE THAT WE RECEIVED IT. AND THEN THE NEXT IS MY INITIAL WHEN I SAW IT AND REVIEWED IT, AND THEN IF IT'S A NORMAL VALUE, I MIGHT JUST WRITE NORMAL OR WHATEVER. AND THE LAST PART IS NOTIFICATION. SO EITHER -- AND WHOEVER INITIALS THAT, EITHER MY MEDICAL ASSISTANT FOR THE NORMAL VALUES, OR MYSELF IF IT'S ABNORMAL, THEN I'LL DIRECTLY CONTACT THE PATIENT AND DISCUSS IT WITH THEM. AND THAT LAST ONE IS THE SIGNIFICANT OR INITIAL SHOWING THE DATE THAT I NOTIFIED THE PATIENT.
MR. SCHENK: ALL RIGHT. IF YOU'LL NOW TURN TO PAGE 6 IN THIS EXHIBIT, EXHIBIT 4938, PAGE 6. DO YOU RECOGNIZE THIS DOCUMENT?
MARK BURNES: YES.
MR. SCHENK: AND WHAT IS THIS?
MARK BURNES: THIS IS ANOTHER LAB TEST FROM THERANOS.
MR. SCHENK: OKAY. LET'S LOOK AT THE -- AGAIN, IS THERE A FAX HEADER AT THE TOP?
MARK BURNES: YES.
MR. SCHENK: WAS THIS DOCUMENT FAXED TO YOUR OFFICE JUST LIKE THE LAST ONE?
MARK BURNES: YES.
MR. SCHENK: WHAT IS THE VISIT DATE? DO YOU SEE THAT?
MARK BURNES: VISIT DATE IS MAY 18TH, 2015.
MR. SCHENK: SO IS THAT FOUR DAYS AFTER THE 26, THE SCORE OF 26 THAT WE JUST SAW?
MARK BURNES: YES.
MR. SCHENK: AND NOW, WHAT IS THE SCORE ON THIS ONE? DO YOU SEE IN THE SECOND BOX THERE'S SOMETHING CALLED PSA TOTAL?
MARK BURNES: THE SCORE IS 1.71.
MR. SCHENK: IF WE COULD ZOOM OUT AND ZOOM IN ON PSA TOTAL. THANK YOU. SO THE FIRST TEST THAT WE SAW WAS A 26. IS THAT RIGHT?
MARK BURNES: YES.
MR. SCHENK: AND NOW WE HAVE A SCORE OF 1.71. HELP ME UNDERSTAND WHAT THAT INFORMATION IS PROVIDING YOU. WHAT ARE YOU LEARNING?
MARK BURNES: THAT VALUE IS MORE CONSISTENT AS THE TRACKING WE EXPECTED FOR DR. ELLSWORTH BASED ON PREVIOUS TESTS.
MR. SCHENK: OKAY. BELOW THAT BOX THERE IS SOME HANDWRITING. DO YOU SEE THAT?
MARK BURNES: YES.
MR. SCHENK: IS THIS ALSO YOUR HANDWRITING?
MARK BURNES: YES.
MR. SCHENK: COULD YOU READ THAT TO THE JURY?
MARK BURNES: IT SAYS, "MAY 19, 2015, D/W," WHICH MEANS DISCUSSED WITH, "THERANOS, CLEARLY SOME FORM OF LAB ERROR OCCURRED AND WILL WORK WITH THEM TO MAKE THIS RIGHT FOR PATIENT. MOST LIKELY TESTING IS IN ERROR FROM MAY 14TH."
MR. SCHENK: AND JUST TO COMPLETE IT, IT LOOKS LIKE ABOUT THE THIRD LINE OF YOUR NOTES WHERE YOU READ, "MAKE THIS RIGHT FOR PATIENT," DOES IT THEN CONTINUE "AND CONFIRM ACCURACY"?
MARK BURNES: YES. I'M SORRY I DIDN'T SEE THAT. "RIGHT FOR PATIENT AND CONFIRM ACCURACY."
MR. SCHENK: OKAY. SO IN HERE YOU WROTE "DISCUSS WITH THERANOS." WHAT DOES THAT MEAN?
MARK BURNES: WE CALLED -- I CONTACTED THEIR ORGANIZATION AND I ENDED UP TALKING TO I BELIEVE IT WAS A REGIONAL LAB DIRECTOR ABOUT THE ISSUE.
MR. SCHENK: AND WHAT DO YOU RECALL FROM THAT CONVERSATION? FIRST, DO YOU RECALL THE NAME OF THE PERSON YOU SPOKE WITH?
MARK BURNES: NO.
MR. SCHENK: AND WHAT DO YOU RECALL FROM THE CONVERSATION?
MARK BURNES: WE HAD A DISCUSSION ABOUT THE FACT THAT WE HAD TWO WIDELY VARIANT VALUES AND WE WANTED TO GET THIS SQUARED AWAY FOR THE PATIENT BEFORE HE LEFT FOR TWO YEARS. SO I ASKED THAT THEY WOULD REPEAT THE TEST A THIRD TIME, AND I'D FEEL A LITTLE BIT MORE COMFORTABLE IF THE THIRD TEST WAS IN AN EXPECTED RANGE. AND THEN I ASKED -- SINCE IT SEEMED TO BE A LAB ERROR OR A DISCREPANCY WITH THEIR LAB, I ASKED IF THEY WOULD ASSUME THE COST FOR REPEAT TESTING AS OPPOSED TO THE PATIENT PAYING FOR IT AGAIN. AND THEY AGREED TO THAT.
MR. SCHENK: OKAY. IF WE PAUSE FOR A MOMENT ON THIS EXHIBIT, 4938, AND I'M GOING TO ASK YOU TO TURN TO THE FIRST EXHIBIT IN YOUR BINDER, THAT'S 4415?
MARK BURNES: SAME SECTION OR THE FIRST SECTION?
MR. SCHENK: THE FIRST TAB AT THE VERY BEGINNING OF THE BINDER.
MARK BURNES: OKAY.
MR. SCHENK: AND YOU'RE NOT ON THIS EMAIL. YOUR HONOR, THE GOVERNMENT OFFERS 4415 AS -- UNDER 803. THE COURT HEARD PRIOR 803(6) TESTIMONY FROM DR. ROSENDORFF ON SEPTEMBER 24TH, FROM MS. CHEUNG ON SEPTEMBER 14TH AND 15TH, DR. DAS LAST WEEK ON NOVEMBER 10TH, AND FROM MR. EDLIN ON OCTOBER 19TH, AIL PROVIDING THE FOUNDATION FOR THIS.
MS. TREFZ: OBJECTION. 802. I BELIEVE, DATE-WISE, THIS IS -- I BELIEVE DATE-WISE THIS IS NOT COVERED BY ANY OF THOSE PRIOR DISCUSSIONS.
JUDGE DAVILA: MR. SCHENK, YOU'RE SUGGESTING THAT THE PREVIOUS TESTIMONY THAT YOU INDICATED PROVIDES AMPLE FOUNDATION FOR THIS DOCUMENT?
MR. SCHENK: YES, YOUR HONOR.
JUDGE DAVILA: THANK YOU. I'LL OVERRULE THE OBJECTION AND ADMIT THE DOCUMENT. THE TOTALITY OF THE PAGES OF THE DOCUMENT ARE ADMITTED.
MR. SCHENK: THANK YOU, YOUR HONOR.
JUDGE DAVILA: THEY MAY BE PUBLISHED.
(GOVERNMENT'S EXHIBIT 4415 WAS RECEIVED IN EVIDENCE.)
MR. SCHENK: IF NOW WE CAN BRING UP EXHIBIT 4415, STARTING ON PAGE 8.
MARK BURNES: IS THAT THE SECOND SECTION?
BY MR. SCHENK:
MR. SCHENK: IT'S STILL THE VERY FIRST TAB IN THE BINDER, 4415, AND I'LL BE READING FROM PAGE 8, THE BOTTOM EMAIL FROM MS. AGUIRRE. IF WE CAN BLOW THAT UP. ON MAY 19TH, 2015, MS. AGUIRRE WRITES TO AN EMAIL GROUP CALLED LAB RERUNS AND A COUPLE OTHER EMPLOYEES. "GOOD MORNING, "DR. MARK BURNES CALLED TO SAY THAT THE RESULTS FOR THE PSA, TOTAL WERE VERY HIGH ON 5/14 SO HE HAD HIS PATIENT COME BACK TO TEST AGAIN AND THE RESULTS FOR THE PSA, TOTAL WERE NORMAL ON 5/18." IF WE CAN TURN THE PAGE. LET ME FIRST ASK, DR. BURNES, IS THAT WHAT WE JUST REVIEWED? YOU SAID THAT YOU CALLED, YOUR PATIENT, DR. ELLSWORTH, HAD VERY HIGH RESULTS ON MAY 14TH AND NORMAL FOUR DAYS LATER ON MAY 18TH?
MARK BURNES: YES.
MR. SCHENK: IF WE COULD NOW TURN TO THE NEXT PAGE, PAGE 9, 4415, PAGE 9. AT THE VERY TOP THIS CONTINUES. "BECAUSE OF THIS, HE IS NOT CONVINCED THAT THE RESULTS FOR 5/14 BELONG TO HIS PATIENT," AND ON THE VERSION ON THE SCREEN THE NAME IS REDACTED BUT THE JURY NOW KNOWS IT'S DR. ELLSWORTH, "AND COULD POSSIBLY BELONG TO ANOTHER PATIENT. "HE WANTS TO BE ASSURED THAT THE RESULTS FROM 5/18 ARE CORRECT FOR HIS PATIENT SO HE IS REQUESTING A RERUN OF THE PSA, TOTAL FOR 5/14 IF POSSIBLE BUT DEFINITELY A RERUN FOR THE PSA, TOTAL FROM 5/18." I'LL PAUSE. DR. BURNES, IS THAT YOUR RECOLLECTION THAT YOU HAD A CONCERN ABOUT THE ACCURACY AND WANTED TO HAVE THE TEST RUN AGAIN?
MARK BURNES: YES.
MR. SCHENK: THE EMAIL CONTINUES, "HE," THAT'S YOU, DR. BURNES, "ALSO WOULD LIKE THE PATIENT TO BE REIMBURSED FOR THE TEST ON 5/14/15 SINCE HE THINKS IT'S INCORRECT. "HE REQUESTED A CALL FROM LAB SUPERVISOR AFTER THE RERUN RESULTS ARE BACK." AND THERE'S A CALL BACK NUMBER PROVIDED. AND IF WE NOW GO FURTHER UP IN THE EMAIL ON PAGE 7.
MARK BURNES: SO TWO PAGES FORWARD?
MR. SCHENK: YES, SIR. THERE'S AN EMAIL FROM DANIEL YOUNG TO A GROUP OF INDIVIDUALS AND THE LAB RERUN GROUP. AND IT READS, "IT LOOKS LIKE ON 5/15, THE ORIGINAL SAMPLE WAS RERUN CONFIRMING THE HIGH RESULT (29 AND 26)," IS THAT NANOGRAMS PER MILLILITER?
MARK BURNES: YES.
MR. SCHENK: "RESPECTIVELY." "TINA -- I SEE THREE RESULTS FOR 5/19. TWO LOW, AND 1 HIGH. DO YOU KNOW WHAT IS GOING ON HERE?" DID I READ THIS CORRECTLY?
MARK BURNES: I DON'T UNDERSTAND THIS EMAIL. I'M UNFAMILIAR WITH IT.
MR. SCHENK: I APPRECIATE THAT. I'M JUST WONDERING IF I READ IT ACCURATELY.
MARK BURNES: YES, YOU DID.
MR. SCHENK: THANK YOU. IF YOU'LL NOW TURN TO PAGE 4 OF THIS EMAIL, A FEW PAGES AHEAD. THERE'S ANOTHER EMAIL FROM DANIEL YOUNG, ALSO ON MAY 19TH, 2015, AND IT READS, "PLEASE SEND REPORT WITH UPDATED RESULT. "CHRISTIAN DOES NOT DO THOSE CALLS ANYMORE. DAN FLOREY HELPS WITH THESE NOW. "DAN - WE DON'T KNOW WHY THE FIRST SAMPLE CAME BACK SO HIGH. IT WAS ACTUALLY RERUN, AND CONFIRMED HIGH ORIGINALLY. A SAMPLE MIXUP IS POSSIBLE AS THE DOCTOR SUGGESTED, BUT HARD TO CONFIRM AT THIS POINT." DR. BURNES, DID YOU SUGGEST TO THERANOS THAT YOU THOUGHT ONE EXPLANATION FOR THE VERY HIGH RESULT FOR DR. ELLSWORTH WAS THAT THERE WAS A SAMPLE MIXUP, THAT YOU RECEIVED RESULTS THAT BELONGED TO A DIFFERENT PATIENT?
MARK BURNES: I DON'T RECALL THAT WAS THE REASON. I SIMPLY THOUGHT IT WAS AN INACCURATE TEST.
MR. SCHENK: YOUR MEMORY IS THAT -- YOUR CONCERN WAS THAT IT WAS AN INACCURATE TEST AND NOT A SAMPLE MIXUP? IS THAT WHAT YOU'RE SAYING?
MARK BURNES: I WAS LEANING TOWARDS THAT.
MR. SCHENK: OKAY. IF WE COULD NOW GO AHEAD ONE PAGE TO PAGE 3 AND START AT THE BOTTOM. THERE'S AN EMAIL FROM DAN FLOREY AND HE WRITES, "DANIEL AND TEAM. "THIS PATIENT VISITED FOR A THIRD TIME LAST WEEK, AND AGAIN THE PSA CAME BACK ELEVATED. CAN YOU PLEAD REVIEW THE CASE? THE DOCTOR WOULD LIKE A CALL ASAP PER THE SALES REP." DR. BURNES, YOU -- WE REVIEWED TWO LAB REPORTS, BOTH FROM MID-MAY 2015. DO YOU RECALL THAT?
MARK BURNES: YES.
MR. SCHENK: AND DID YOU ASK DR. ELLSWORTH TO GO GET A THIRD TEST AFTER THE SECOND?
MARK BURNES: YES.
MR. SCHENK: THE EMAIL CONTINUES BELOW THE PART THAT IS UP FOR THE JURY, THERE ARE TWO LINES HERE AND THEN WE'LL CONTINUE TO THE TOP OF THE NEXT PAGE. THESE TWO LINES READ 5/14, AND THEN THERE'S AN I.D. NUMBER, 26.1; 5/18, PSA 1.71. DR. BURNES, WERE THOSE THE TWO PSA, TOTAL SCORES THAT WE JUST REVIEWED?
MARK BURNES: YES.
MR. SCHENK: AND NOW IF WE'LL GO TO THE TOP OF PAGE 4 AND CAPTURE THE END OF THIS EMAIL. THE TOP OF PAGE 4. THE VERY TOP OF THIS EMAIL SHOWS THE THIRD TEST RESULT, JUNE 11, A PSA SCORE OF 22.8. DR. BURNES, DO YOU RECALL A THIRD THERANOS PSA TEST FOR DR. ELLSWORTH THAT RETURNED A VALUE OF 22.8?
MARK BURNES: YES.
MR. SCHENK: NOW, IF WE GO BACK IN THE EMAIL, LET'S START AT THE VERY BOTTOM OF PAGE 2 AND JUST CAPTURE WHO SENT THE EMAIL, BUT WE'LL READ AT THE TOP OF PAGE 3, THE VERY BOTTOM OF PAGE 2. MR. BALWANI, SUNNY BALWANI, WRITES AN EMAIL JUNE 15, 2015. NOW TURN THE PAGE TO PAGE 3 TO CAPTURE THE TEXT. MR. BALWANI WRITES, "TINA. CAN YOU INVESTIGATE THIS. "DANIEL. I DO NOT BELIEVE SAMPLE MIXUP IS POSSIBLE BY A REMOTE SHOT IN OUR SYSTEM BUT SINCE THE MOST RECENT VISIT IS ON 6/11 AND SHOULD HAVE THE SAMPLE IN OUR LABS, WE SHOULD BE ABLE TO CHECK THE LABEL ON SAMPLE ACROSS THE ENTIRE SYSTEMS. WE SHOULD START BY RERUNNING THE SAMPLE TO START AND THE WORK BACKWARDS FROM THERE. "TINA. CAN YOU PLEASE OWN THIS AND UPDATE ME IN REALTIME. MAX. CAN U FREE UP YOUR TIME AND START TRACKING THIS SAMPLE AND MAKE SURE EVERYTHING CHECKS OUT THERE. HAVE SOMEONE PHYSICALLY LOOK AT LABELS TO MAKE SURE LABELS MATCH WITH WHAT WAS DRAWN AT PSC AND THE ONE PRINTED IN LAB, IF PRINTED IN LAB. PLEASE UPDATE IN REAL TIME." NOW, DR. BURNES, IF YOU WILL TURN TO PAGE 2, THERE'S AN EMAIL FROM DANIEL YOUNG. MR. YOUNG WRITES, "THE MOST RECENT SAMPLE WAS FLAGGED FOR HEMOLYSIS AND CLOTTING. THIS SAMPLE WAS USED FOR THE PSA RESULT. "PSA FROM VISITS 1 AND 3 WERE RUN ON EDISON. VISIT 2 WAS RUN IN PHOENIX. "THIS IS LOOKING LIKE EITHER A SAMPLE INTEGRITY ISSUE, OR SOME OTHER INTERFERANT IN THE PATIENT SAMPLE AFFECTED THE PSA TEST ON EDISON." DR. BURNES, WHEN YOU WERE RECEIVING TEST RESULTS FROM THERANOS, DID YOU KNOW ON WHAT DEVICE THERANOS WAS RUNNING THE TESTS?
MARK BURNES: I WAS TOLD IT WAS A DEVICE IN SCOTTSDALE USUALLY.
MR. SCHENK: YOU WERE TOLD BY WHOM?
MARK BURNES: THE REPRESENTATIVE FROM THERANOS.
MR. SCHENK: AND YOU USED THE WORD "USUALLY." WHAT DO YOU MEAN BY THAT?
MARK BURNES: AS FAR AS I KNOW, THEY HAD TESTING SITES IN SCOTTSDALE WHERE THEY SENT THE LABS FROM THE WALGREENS.
MR. SCHENK: SO IT WAS YOUR UNDERSTANDING THAT THE RESULTS THAT YOU WERE REVIEWING FOR DR. ELLSWORTH'S TESTS WERE RUN IN ARIZONA?
MARK BURNES: I ASSUMED THAT.
MR. SCHENK: AND NOW IF WE CAN TURN TO THE FIRST PAGE OF THIS EXHIBIT 4415, PAGE 1. WE'LL START AT THE BOTTOM. MR. BALWANI WRITES, "IF IT IS THEN WE SHOULD EXPLAIN THIS TO THE DOC." IF WE MOVE UP ONE EMAIL, MR. FLOREY WRITES, "SUNNY. "DANIEL AND I WERE ABLE TO CONNECT WITH DR. BURNES. THE CALL WAS POSITIVE AND THE DOCTOR CALLED OUR PLAN TO REDRAW THE GUEST AFTER HE RETURNS FROM VACATION IN TWO WEEKS 'SOLID.' DANIEL DISCUSSED THE SPECIMEN INTEGRITY ISSUES WITH HIM, WHICH SATISFIED HIM. HE WAS TALKATIVE, SHARED THAT HE LIKES OUR COST AND REALLY APPRECIATES THAT WE SET OUT TO TAKE A SMALLER AMOUNT OF BLOOD THAN LABCORP, WHO HE HAS USED FOR 20 PLUS YEARS. BASED ON THE GOOD THINGS HE SAID ABOUT OUR SALES REP (JESSICA) I EXPECT THAT WHEN WE WRAP THIS CASE UP IN A COUPLE OF WEEKS IT WILL REALLY STRENGTHEN THE RELATIONSHIP." DR. BURNES, DOES THIS PARAGRAPH SUMMARIZE A CONVERSATION THAT YOU RECALL HAVING WITH SOMEONE FROM THERANOS?
MARK BURNES: I DON'T RECALL EXACTLY, BUT THE TONE OF IT WAS LIKE THIS. IT WAS VERY POSITIVE AND THEY WERE PLEASANT.
MR. SCHENK: GREAT. AND IF WE CAN GO TO THE VERY TOP OF THE EMAIL. DR. BURNES, DO YOU SEE AT THE VERY TOP WHERE SOMEONE NAMED SUNNY BALWANI FORWARDS THIS EMAIL CHAIN TO ELIZABETH HOLMES ON JUNE 15TH, 2015?
MARK BURNES: YES.
MR. SCHENK: IF WE CAN NOW GO BACK TO THE PREVIOUS EXHIBIT, WHICH IS 4938, AND WE'LL START ON PAGE 5. DR. BURNES, DO YOU RECOGNIZE THIS DOCUMENT?
MARK BURNES: YES.
MR. SCHENK: AND WHAT IS THIS?
MARK BURNES: IT'S ANOTHER LAB RESULT FROM THERANOS.
MR. SCHENK: AND DO YOU SEE THE VISIT DATE?
MARK BURNES: THE VISIT DATE IS JUNE 11TH, 2015.
MR. SCHENK: DR. BURNES, IS THIS THE THIRD THERANOS TEST RESULT, THE THIRD IN TIME?
MARK BURNES: YES.
MR. SCHENK: AND WHAT WAS THE PSA TOTAL STORE THIS TIME?
MARK BURNES: 22.8.
MR. SCHENK: SO AM I RIGHT THE FIRST WAS 26, AND THEN 1.7, AND NOW WE'RE SEEING A SCORE OF 22?
MARK BURNES: YES.
MR. SCHENK: WHEN YOU RECEIVED THIS RESULT, DID YOU REACH OUT TO THERANOS AS WE SAW IN THAT EMAIL CHAIN AND HAVE A CONVERSATION?
MARK BURNES: YES.
MR. SCHENK: AFTER YOU RECEIVED THIS RESULT, WHAT WAS THE NEXT STEP THAT YOU THOUGHT WAS APPROPRIATE TO TAKE?
MARK BURNES: WELL, I WAS BECOMING MORE CONCERNED ABOUT THE TEST, SO I ACTUALLY ASKED TO TALK TO THEIR NATIONAL LAB DIRECTOR, WHICH THEY DIRECTLY AND KINDLY DID.
MR. SCHENK: AND WHAT DO YOU RECALL ABOUT THAT CONVERSATION?
MARK BURNES: BASICALLY I WAS EXPRESSING SOME LACK OF CONFIDENCE ON THE RESULTS WITH THIS -- THE NEW TESTING, THE WAY IT WAS BEING DONE, AND I ASKED, TO RESOLVE, FOR THE PATIENT TO DO A FOURTH PSA THE TRADITIONAL WAY, AND IF THEY WOULD PAY FOR THE LAB, AND THEY AGREED TO THAT.
MR. SCHENK: AND WHAT DO YOU MEAN "THE TRADITIONAL WAY"?
MARK BURNES: YOU KNOW, SENDING IT OUT TO A -- IF THEY CAN DO IT IN HOUSE OR SEND IT TO LABCORP, THE TRADITIONAL WAYS PSA'S WERE DONE, NOT THE FINGER POKE.
MR. SCHENK: NOT THE?
MARK BURNES: NOT THE FINGERSTICK. I WANTED IT TO BE DONE BY WHATEVER TRADITIONAL WAY IT WAS NORMALLY DONE.
MR. SCHENK: I SEE. AND IF WE CAN GO TO THE BOTTOM OF THIS DOCUMENT. THIS VERSION OF THE LAB TEST HAS A SECTION CALLED PERFORMING SITE. DO YOU SEE THAT? SORT OF IN THE BOTTOM, THE BOTTOM LEFT.
MARK BURNES: OH, YEP, I SEE IT NOW. SO IT SAYS, "NEWARK - 7373 GATEWAY BOULEVARD, NEWARK CALIFORNIA."
MR. SCHENK: NOW, IF WE CAN TURN TO PAGE 4 -- I'M SORRY, PAGE 4, ONE PAGE PRIOR. DO YOU RECOGNIZE THIS DOCUMENT?
MARK BURNES: YES.
MR. SCHENK: WHAT IS THIS?
MARK BURNES: IT'S A LAB RESULT FROM THERANOS.
MR. SCHENK: DO YOU SEE THE VISIT DATE?
MARK BURNES: THE VISIT DATE IS JUNE 30TH, 2015.
MR. SCHENK: DR. BURNES, IS THIS NOW THE FOURTH THERANOS PSA TEST FOR MR. -- FOR DR. ELLSWORTH?
MARK BURNES: YES.
MR. SCHENK: AND WHAT IS THE PSA TOTAL SCORE THIS TIME?
MARK BURNES: OH, OKAY. BEAR WITH ME. I'M STRUGGLING. I HAVE A VERY NARROW FOCUS OF VISION. I SEE THE PSA TOTAL INTERPRETIVE DATA, PSA ANTIGEN TOTAL.
MR. SCHENK: DR. BURNES, IT'S ON THE SCREEN IN FRONT OF YOU IF IT'S EASIER. IT'S HIGHLIGHTED.
MARK BURNES: OH. 0.9 I BELIEVE.
MR. SCHENK: DID YOU SAY 0.9?
MARK BURNES: I SHOULD BE ABLE TO SEE IT ON HERE. LET ME GET THE RIGHT -- I APOLOGIZE FOR STRUGGLING WITH THIS.
MR. SCHENK: NO APOLOGY NEEDED. YOUR HONOR, MAY I APPROACH?
JUDGE DAVILA: YES.
MARK BURNES: YES, I SEE THE PSA TOTAL THERE. OH, I'M LOOKING DOWN HERE. OKAY.
BY MR. SCHENK:
MR. SCHENK: (INDICATING.)
MARK BURNES: 0.95.
MR. SCHENK: THANK YOU. AND THEN AT THE BOTTOM AGAIN WE SEE A KEY WITH A TEST PROCESSED LOCATION. DO YOU SEE THAT? WAS THE TEST PROCESSED AT THERANOS LABORATORIES IN SCOTTSDALE, ARIZONA?
MARK BURNES: YES.
MR. SCHENK: SO THE FOURTH DRAW IS ONE THAT YOU DESCRIBED AS WANTING TO BE PERFORMED THROUGH TRADITIONAL METHODS; IS THAT RIGHT?
MARK BURNES: YES.
MR. SCHENK: NOW THAT YOU RECEIVED THIS FOURTH RESULT, HOW DID YOU FEEL ABOUT THE STATE OF DR. ELLSWORTH'S HEALTH?
MARK BURNES: I FELT MORE REASSURED THAT THAT WAS THE CORRECT VALUE.
MR. SCHENK: OKAY. I WANT TO SHOW YOU JUST A COUPLE OTHER DOCUMENTS. IF YOU'LL NOW TURN TO PAGE 3. PAGE 3 APPEARS TO BE ANOTHER -- ARE YOU THERE?
MARK BURNES: YES.
MR. SCHENK: -- ANOTHER THERANOS LAB TEST THAT WAS FAXED TO YOUR OFFICE NOW IN MARCH OF 2016. DO YOU SEE THAT?
MARK BURNES: I SEE MARCH 29TH, 2016.
MR. SCHENK: AND IT SAYS IN THE CAPTION THAT "THIS REPORT CONTAINS CORRECTED RESULTS." DO YOU SEE THAT?
MARK BURNES: WHERE WOULD I BE LOOKING AT?
MR. SCHENK: JUST TO THE RIGHT OF THE WORD "THEY."
MARK BURNES: YES, OKAY, I SEE THAT.
MR. SCHENK: AND THEN IF WE GO INTO THE BOX THAT IS LABELLED PROSTATE SPECIFIC ANTIGEN TOTAL, THE SCORE NOW READS "VOID 26.2." DO YOU SEE THAT?
MARK BURNES: YES.
MR. SCHENK: AND BELOW THAT "PROSTATE SPECIFIC ANTIGEN TOTAL AS PREVIOUSLY REPORTED IS VOIDED AND THIS RESULT SHOULD NOT BE USED OUT OF AN ABUNDANCE OF CAUTION. REDRAW IS RECOMMENDED AS CLINICALLY INDICATED." WHAT INFORMATION DID YOU UNDERSTAND WAS BEING COMMUNICATED TO YOU THROUGH THIS DOCUMENT?
MARK BURNES: FORMAL DOCUMENTATION THAT THAT LAB TEST ON MAY 14TH, 2015, ABOUT NINE MONTHS BEFORE, WAS INVALID.
MR. SCHENK: AT THE BOTTOM OF THIS DOCUMENT THERE'S A KEY, AND THE FIRST ENTRY INFORMS THAT THE TEST WAS PROCESSED AT THERANOS LABORATORIES IN NEWARK, CALIFORNIA. DO YOU SEE THAT?
MARK BURNES: I SEE INTERPRETIVE -- OH, I SEE IT. SO TEST PROCESSED AT THERANOS LABORATORY, 7373 GATEWAY BOULEVARD, NEWARK, CALIFORNIA.
MR. SCHENK: AND IF YOU'LL TURN TO PAGE 2 IN THE EXHIBIT. DR. BURNES, IS THIS A REPORT VOIDING THE THIRD TEST, THE TEST THAT PRODUCED A 22.8 PSA SCORE?
MARK BURNES: YES.
MR. SCHENK: AND WAS THIS ALSO SENT TO YOU IN MARCH OF 2016?
MARK BURNES: YES, MARCH 29TH, 2016.
MR. SCHENK: THANK YOU. AND THEN ONE FINAL PAGE. IF YOU'LL TURN TO PAGE 8 OF THIS EXHIBIT. DR. BURNES, DID DR. ELLSWORTH GO TO LABCORP IN 2017 AND GET A PSA TEST?
MARK BURNES: YES.
MR. SCHENK: AND WAS THE PSA SCORE THAT TIME A 2.0?
MARK BURNES: YES.
MR. SCHENK: IF I CAN ASK YOU TO TURN FINALLY TO PAGE 7, THAT WAS THE FIRST THERANOS TEST RESULT, THE 26.1. ARE YOU THERE?
MARK BURNES: YES.
MR. SCHENK: DR. BURNES, DO YOU HAVE AN OPINION ON THE ACCURACY OF THIS TEST?
MARK BURNES: WHICH TEST?
MR. SCHENK: THE ONE THAT WAS SENT TO YOUR OFFICE ON MARCH 16TH, THE VISIT DATE WAS -- I'M SORRY, WAS SENT TO YOUR OFFICE ON MAY 16TH, 2015, THE VISIT DATE WAS MAY 14TH, 2015, AND THE SCORE WAS A 26.1. IT'S ON PAGE 7.
MARK BURNES: I UNDERSTAND NOW.
MR. SCHENK: DO YOU HAVE AN OPINION ON THE ACCURACY OF THIS TEST?
MARK BURNES: YES. I BELIEVE THAT TEST WAS INVALID.
MR. SCHENK: AND WHY DO YOU SAY THAT?
MARK BURNES: IT WAS NOT CONSISTENT WITH THE PATTERN THAT WE HAVE BEEN SEEING OR THE EXPECTED RESULT, AND THE FACT THAT THE REPEAT TEST, THE FOURTH TEST IN 2015 WAS CLOSE TO THE EXPECTED RESULT, AND THIS FOLLOW-UP TEST WHEN THE PATIENT RETURNED FROM THE MISSIONARY WORK WAS WHERE IT SHOULD BE.
MR. SCHENK: THANK YOU. YOUR HONOR, MAY I HAVE A MOMENT?
JUDGE DAVILA: YES.
(DISCUSSION AMONGST GOVERNMENT COUNSEL OFF THE RECORD.)
MR. SCHENK: THANK YOU, YOUR HONOR. NO FURTHER QUESTIONS.
JUDGE DAVILA: CROSS-EXAMINATION?
MS. TREFZ: YES, YOUR HONOR.
CROSS-EXAMINATION BY MS. TREFZ:
MS. TREFZ: GOOD MORNING, DR. BURNES.
MARK BURNES: GOOD MORNING.
MS. TREFZ: MY NAME IS KATIE TREFZ AND I REPRESENT MS. HOLMES, AND I HAVE SOME QUESTIONS FOR YOU. I WANT TO START WITH UNDERSTANDING HOW YOU WERE INTRODUCED TO THERANOS. IN PARTICULAR, WHEN THERANOS FIRST STARTED OFFERING BLOOD TESTING, IS IT FAIR TO SAY THAT YOU WERE EXCITED?
MARK BURNES: I WAS VERY MUCH INTERESTED IN THIS WAY OF TESTING.
MS. TREFZ: AND IS ONE OF THE REASONS WHY YOU WERE INTERESTED IN THE THERANOS SERVICE THAT THERANOS CHARGED APPROXIMATELY EIGHT TIMES LESS THAN OTHER LABORATORIES?
MARK BURNES: YES.
MS. TREFZ: AND DO YOU RECALL THAT THERANOS PUBLISHED THEIR PRICES ON THE INTERNET?
MARK BURNES: I DON'T RECALL SEEING IT ON THE INTERNET, BUT I DO RECALL SEEING THE PRICES ON THE -- SOMEWHERE ON DOCUMENTATION THAT WAS PROVIDED TO THE OFFICE.
MS. TREFZ: OKAY. AND DID YOU UNDERSTAND THAT THERANOS CHARGED THE SAME FOR INSURED AND UNINSURED PATIENTS?
MARK BURNES: NO, I DIDN'T KNOW THAT ASPECT.
MS. TREFZ: OKAY. THERE WAS A THERANOS WALGREENS PATIENT SERVICE CENTER DOWN THE STREET FROM YOUR PRACTICE; RIGHT?
MARK BURNES: YES.
MS. TREFZ: AND DID THIS LOCATION ADD TO THE CONVENIENCE OF THERANOS TESTING FOR YOU?
MARK BURNES: YES.
MS. TREFZ: AND DID YOU ALSO LIKE THE GOAL OF TAKING LESS BLOOD?
MARK BURNES: YES.
MS. TREFZ: AND IS IT FAIR TO SAY THAT YOU HOPED THAT THERANOS WOULD SUCCEED?
MARK BURNES: VERY MUCH SO.
MS. TREFZ: I THINK WE ESTABLISHED ALREADY ON DIRECT THAT YOU'RE IN PRIVATE PRACTICE; CORRECT?
MARK BURNES: YES.
MS. TREFZ: AND YOUR PRACTICE IS INTERNAL MEDICINE?
MARK BURNES: YES.
MS. TREFZ: IS IT FAIR TO SAY THAT AROUND TWO-THIRDS OF THE TIME THAT YOU'RE EXAMINING PATIENTS, YOU'RE DOING WELLNESS EXAMS?
MARK BURNES: YES.
MS. TREFZ: AND DO THOSE OFTEN COME WITH BLOOD TESTS?
MARK BURNES: YES.
MS. TREFZ: AND YOU CURRENTLY HAVE WHAT IS CALLED A CONCIERGE PRACTICE; RIGHT?
MARK BURNES: YES.
MS. TREFZ: AND CAN YOU EXPLAIN WHAT THAT IS?
MARK BURNES: IT'S A --
MR. SCHENK: OBJECTION. RELEVANCE.
MARK BURNES: OH.
JUDGE DAVILA: COUNSEL, WHAT IS THE RELEVANCE OF THIS?
MS. TREFZ: I WOULD LIKE TO ESTABLISH THE SCOPE OF THE BLOOD TESTS THAT HE ORDERS. SO IT'S JUST FOUNDATIONAL TO UNDERSTANDING THE CONTEXT OF HIS PRACTICE.
JUDGE DAVILA: AT THE TIME OF THE TEST?
MS. TREFZ: THAT WAS GOING TO BE MY NEXT QUESTION, BUT I, I --
JUDGE DAVILA: MAYBE -- IS IT -- ARE YOU TRYING TO DETERMINE WHETHER OR NOT HIS PRACTICE WAS CONCIERGE AT THE TIME OF THE TEST?
MS. TREFZ: I WAS GOING TO ASK THAT AFTER HE DEFINED IT, BUT YES.
JUDGE DAVILA: WHY DON'T WE.
MS. TREFZ: I'M HAPPY TO DO IT IN THAT WAY, YOUR HONOR.
MS. TREFZ: WAS YOUR PRACTICE A CONCIERGE PRACTICE IN 2015?
MARK BURNES: THAT WAS A TERM THAT COULD BE APPLIED, YES.
MS. TREFZ: AND COULD YOU EXPLAIN WHAT THAT TERM MEANS?
MARK BURNES: ABOUT 5 PERCENT OF INTERNS PRACTICE THIS WAY CURRENTLY WHERE WE OFFER A FORM OF PRACTICE, WE'RE DOING CARE FOR THE PATIENT ABOVE AND BEYOND WHAT IS NORMALLY COVERED BY THE INSURANCE. AND THE PRIMARY PIECE OF THIS IS A FEE WE CHARGE FOR AN ANNUAL WELLNESS EXAM.
MS. TREFZ: AND ABOUT HOW MANY PATIENTS WERE IN YOUR CONCIERGE PRACTICE AS OF 2015?
MARK BURNES: ABOUT 180.
MS. TREFZ: OKAY. DID YOU SEND MANY OF THOSE PATIENTS TO THERANOS FOR TESTING?
MARK BURNES: COULD YOU DEFINE "MANY" THERE?
MS. TREFZ: DID YOU SEND ABOUT A QUARTER TO A THIRD OF THOSE PATIENTS TO THERANOS FOR TESTING?
MARK BURNES: A BETTER WAY OF ANSWERING IT, I MIGHT TRY, WOULD BE THAT THE MAJORITY OF MY LABS WERE SENT TO THE CLEVELAND CLINIC AT THAT TIME -- MOST OF MY LAB WORK WAS DONE AT THE CLEVELAND CLINIC AT THAT TIME, SO MOST OF THE LAB WORK I PERFORMED ON MY PATIENCE ON AN ANNUAL BASIS WAS FOR THE WELLNESS EXAM, AND THAT WAS SENT TO THE CLEVELAND CLINIC IN OHIO. I WOULD ESTIMATE ABOUT 10 PERCENT OF THE LABS AT THAT TIME I WOULD SEND OUT TO THERANOS.
MS. TREFZ: AND JUST SO --
MARK BURNES: AND SO THE TOTAL NUMBER OF LABS I WOULD DO PER YEAR.
MS. TREFZ: OKAY. SO JUST IN TERMS OF WHAT WE'RE DISTINGUISHING THE DIFFERENCE BETWEEN MY QUESTION AND YOUR ANSWER IS THAT I WAS ASKING ABOUT PATIENTS AND YOU WERE TALKING ABOUT NUMBER OF TESTS, RIGHT, THE NUMBER OF LAB TESTS?
MARK BURNES: OKAY.
MS. TREFZ: WHICH IS FINE. I JUST WANTED TO MAKE SURE THAT I WAS UNDERSTANDING THE DIFFERENCE. IS IT FAIR THAT --
MARK BURNES: COULD YOU RESTATE THAT? I'M NOT SURE WHAT THE POINT IS.
MS. TREFZ: SURE. MY QUESTION WAS, DID YOU SEND ABOUT A QUARTER TO A THIRD OF YOUR PATIENTS TO THERANOS FOR TESTING? AND I UNDERSTOOD YOUR RESPONSE, BUT YOU'LL CORRECT ME IF I MISUNDERSTOOD, I UNDERSTOOD YOUR RESPONSE TO MEAN THAT, THAT REGARDLESS OF THE NUMBER OF PATIENTS, THE MAJORITY OF YOUR LAB TESTING WAS DONE AT CLEVELAND CLINIC.
MARK BURNES: YES. A BETTER WAY TO PROBABLY STATE IT IS BECAUSE WE AUTOMATICALLY DID THESE TESTS ONCE A YEAR FOR ALL OF THE PATIENTS OVER AGE 50. IF LABS OCCURRED OUTSIDE OF THAT ANNUAL WINDOW, SO THE TOTAL LABS THROUGHOUT THE YEAR WOULD PROBABLY BE 10 PERCENT TO THERANOS, BUT IF ISSUES CAME UP OUTSIDE OF THE ANNUAL PHYSICAL LABS, PROBABLY IT WOULD BE FAIR TO SAY ABOUT A QUARTER TO A THIRD WOULD HAVE BEEN THERANOS.
MS. TREFZ: OKAY. THANK YOU. ARE YOU ABLE TO QUANTIFY THE NUMBER OF TESTS THAT WOULD BE?
MARK BURNES: I'M SORRY, I DON'T RECALL.
MS. TREFZ: THAT'S OKAY. IS IT TRUE THAT PATIENTS OF YOURS HAD TESTS AT THERANOS FOR APPROXIMATELY A YEAR BEFORE MR. ELLSWORTH'S TEST THAT WAS THE SUBJECT OF YOUR DIRECT EXAMINATION?
MARK BURNES: YES, I BELIEVE THAT IS TRUE.
MS. TREFZ: AND WITH THE EXCEPTION OF DR. ELLSWORTH'S PSA TEST, DID, DID YOU HAVE ANY ISSUE WITH THERANOS'S TESTS UP TO 2015?
MARK BURNES: NO.
MS. TREFZ: YOU TESTIFIED ON DIRECT THAT YOU BROUGHT THE ISSUE THAT YOU IDENTIFIED TO THERANOS'S ATTENTION; CORRECT?
MARK BURNES: YES.
MS. TREFZ: AND BASED ON YOUR INTERACTIONS WITH THERANOS, DID YOU UNDERSTAND THAT THERANOS HAD OR WAS IN THE PROCESS OF INVESTIGATING THE ISSUE?
MARK BURNES: YES.
MS. TREFZ: DID, DID THE THERANOS PERSONNEL THAT YOU SPOKE WITH INDICATE AN INTEREST IN MAKING THE SITUATION RIGHT?
MARK BURNES: YES.
MS. TREFZ: AND DID THEY EXPRESS AN INTEREST IN UNDERSTANDING WHAT HAD HAPPENED WITH THE TESTS?
MARK BURNES: YES.
MS. TREFZ: I'D LIKE TO BRING UP, IF WE CAN, EXHIBIT 4415, WHICH YOU DISCUSSED WITH THE GOVERNMENT. SO IF YOU CAN -- 4415 I THINK IS THE FIRST TAB IN THE BINDER THAT YOU HAD FROM THE GOVERNMENT.
MARK BURNES: OKAY.
MS. TREFZ: OKAY. I WANTED TO JUST FOCUS ON THE TOP EMAIL HERE FROM MR. BALWANI TO MS. HOLMES. IS THE DATE OF THE EMAIL JUNE 15TH, 2015?
MARK BURNES: EXCUSE ME, WHICH PAGE ARE WE LOOKING AT?
MS. TREFZ: I'M SORRY. WE'RE LOOKING AT PAGE 1.
MARK BURNES: OKAY.
MS. TREFZ: AND THE VERY TOP -- THE EMAIL AT THE VERY TOP.
MARK BURNES: OKAY.
MS. TREFZ: IS THE DATE ON THE EMAIL JUNE 15TH, 2015?
MARK BURNES: YES.
MS. TREFZ: AND DO YOU RECALL WHETHER THAT WAS AFTER THE JUNE 11TH, 2015 TEST THAT YOU RECEIVED FROM THERANOS?
MARK BURNES: THE SPECIFIC ORDER I DON'T -- I'M NOT SURE HOW TO ANSWER THAT QUESTION TO BE HONEST.
MS. TREFZ: OKAY. THAT'S FINE. WHY DON'T WE BRING UP, IF WE CAN, 4438, PAGE 5. AND MY QUESTION FIRST, MR. BENNETT, IS DO WE HAVE THE SAME REDACTIONS THAT THE GOVERNMENT HAD?
MR. BENNETT: A LITTLE MORE REDACTION.
MS. TREFZ: A LITTLE MORE. OKAY. THAT'S FINE. IF WE CAN GO TO 4938.
JUDGE DAVILA: 4938?
MS. TREFZ: YES. THANK YOU.
MARK BURNES: PAGE 5?
MS. TREFZ: PAGE 5, YES. IF WE CAN JUST HIGHLIGHT THE VISIT DATE ON THAT RESULT.
MS. TREFZ: JUST FOR THE SAKE OF CLARITY, IS IT FAIR TO SAY THAT THE EMAIL FROM MR. BALWANI TO MS. HOLMES ON JUNE 15TH, 2015 IS AFTER THE JUNE 11TH VISIT DATE REFLECTED ON 4438?
MARK BURNES: YES.
MS. TREFZ: 4938?
MARK BURNES: YES. SORRY.
MS. TREFZ: AND YOU DON'T HAVE ANY UNDERSTANDING ABOUT WHAT MS. HOLMES KNEW ABOUT DR. ELLSWORTH'S TESTS PRIOR TO THIS DATE; CORRECT?
MARK BURNES: COULD YOU RESTATE THE QUESTION?
MS. TREFZ: YOU DON'T HAVE ANY PERSONAL KNOWLEDGE OF WHAT MS. -- OF WHAT MS. HOLMES MAY OR MAY NOT HAVE KNOWN ABOUT DR. BURNES'S TEST RESULTS?
MARK BURNES: NO.
MS. TREFZ: OKAY. THANK YOU. IF WE CAN STAY ON 4938 FOR A MOMENT. I WANT TO GO TO -- LET'S START WITH THE PAGE 7 PLEASE, MR. BENNETT. AND I WANT TO JUST HIGHLIGHT AT THE TOP HERE, DO YOU RECALL MR. SCHENK POINTED YOU -- EVEN FURTHER UP, PLEASE. THANK YOU. DO YOU RECALL THAT MR. SCHENK POINTED YOU TO THE FAX HEADER ON THIS PAGE?
MARK BURNES: YES.
MS. TREFZ: AND OVER ON THE RIGHT-HAND SIDE IS THERE A FAX NUMBER LISTED FOR THERANOS?
MARK BURNES: ON PAGE 3? WHERE IS IT IN RELATIONSHIP TO THAT?
MS. TREFZ: DOWN BELOW.
MARK BURNES: AND IS THAT THE NUMBER 866?
MS. TREFZ: YES. AND WHAT IS THE AREA CODE?
MARK BURNES: I'M SORRY. LET ME READ THAT.
MS. TREFZ: IN PARTICULAR I'M LOOKING AT THE FAX NUMBER TO THE RIGHT OF THE LAB.
MARK BURNES: LOOKING AT THE NUMBER THAT SAYS LAB, AND IS IT ABOVE OR BELOW IT? OH, HERE IT IS. I FOUND IT. SO IT SAYS FAX. IT SAYS (650) 852-9594.
MS. TREFZ: AND DO YOU KNOW WHETHER THE 650 AREA CODE, IS THAT AN AREA CODE IN ARIZONA?
MARK BURNES: I DO NOT KNOW.
MS. TREFZ: OKAY. AND DO YOU SEE LISTED ABOVE 13 -- DO YOU SEE THE ADDRESS OF THE THERANOS LAB LISTED ABOVE?
MARK BURNES: WHERE IT SAYS 1365 NORTH SCOTTSDALE?
MS. TREFZ: YES. DO YOU SEE THE ADDRESS LISTED THERE? AND IS THAT THE ADDRESS LISTED AS SCOTTSDALE, ARIZONA?
MARK BURNES: YES.
MS. TREFZ: AND IS THERE A FAX SERVER NUMBER ON THE TOP OF THE -- LISTED ON THE TOP OF THE FAX HERE, KIND OF AN ORIGINATING NUMBER?
MARK BURNES: I SEE FAX SERVER AND NUMBER -- I SEE PAGE 2 OF 3. I'M NOT SURE WHERE THE NUMBER IS AT.
MS. TREFZ: AND DO YOU KNOW WHETHER THE 650 NUMBER IS A NORTHERN CALIFORNIA NUMBER?
MARK BURNES: I DO NOT KNOW.
MS. TREFZ: OKAY. I'D JUST LIKE TO GO FORWARD TO PAGE 6. IF YOU CAN GO TO THE TOP AGAIN. I'D JUST LIKE TO NOTE THERE'S NO -- DO YOU SEE WHETHER THERE'S ANY ORIGINATION NUMBER FROM THE FAX SERVER AT THERANOS?
MARK BURNES: I'M AT THE TOP, AND I SEE A THING THAT SAYS THERANOS FAX SERVER, A DASH AND A GREATER SIGN, AND THEN I SEE A THING THAT SAYS IT LOOKS LIKE GE 2/3 -- OR, NO, IT'S PAGE.
MS. TREFZ: DO YOU SEE -- I'M SORRY.
MARK BURNES: MY COPY IS MISSING THE FIRST PART OF THE PAGE, I THINK.
MS. TREFZ: DO YOU SEE AN ORIGINATION NUMBER ON THE TOP OF THIS FAX?
MARK BURNES: WHERE WOULD THAT BE LOCATED IN RELATIONSHIP TO THE WORD FAX SERVER?
MS. TREFZ: I DON'T SEE ONE. THAT'S WHY I'M ASKING.
MARK BURNES: OKAY. I DON'T SEE ONE EITHER.
MS. TREFZ: BUT THERE'S A FAX NUMBER ON THE RIGHT-HAND SIDE IN THE SAME PLACE THAT THERE WAS BEFORE; CORRECT?
MARK BURNES: YES.
MS. TREFZ: OKAY. HAVE YOU -- OVER THE COURSE OF YOUR CAREER, HAVE YOU PRIMARILY USED OTHER LAB COMPANIES OTHER THAN THERANOS?
MARK BURNES: BESIDES CLEVELAND CLINIC, I HAVE USED LABCORP AND OCCASIONALLY SONORA QUEST.
MS. TREFZ: AND HAVE YOU HAD ANY OTHER TESTING ISSUES WITH THOSE OTHER LABS?
MARK BURNES: YES.
MR. SCHENK: YOUR HONOR, OBJECTION. RELEVANCE.
JUDGE DAVILA: SUSTAINED.
MS. TREFZ: MAY I EXPLAIN, OR NO?
JUDGE DAVILA: CAN YOU ASK ANOTHER QUESTION?
MS. TREFZ: OKAY.
MS. TREFZ: HAVE YOU EVER HAD AN ISSUE WITH ANOTHER LAB WHERE YOUR PATIENT'S LABS WERE SWITCHED WITH ANOTHER PATIENT'S LABS?
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: I'LL ALLOW THAT. YOU CAN ANSWER THAT QUESTION, SIR.
MARK BURNES: YES.
BY MS. TREFZ:
MS. TREFZ: AND OVER THE COURSE OF YOUR CAREER -- I THINK YOU TESTIFIED OVER THE COURSE OF YOUR CAREER IN PRIVATE PRACTICE YOU'VE, YOU'VE REVIEWED OVER 10,000 PSA RESULTS; IS THAT CORRECT?
MARK BURNES: YES.
MS. TREFZ: AND DO YOU, DO YOU HAVE A SENSE OF -- OR ARE YOU AWARE OF RESEARCH THAT HAS SHOWN THAT THERE ARE LAB ERRORS THAT OCCASIONALLY OCCUR AT LABORATORIES?
MARK BURNES: I HAVEN'T SEEN THE RESEARCH, BUT COMMON SENSE WOULD DICTATE THAT OCCASIONALLY ERRORS CAN OCCUR.
MS. TREFZ: AND WHAT IS YOUR UNDERSTANDING OF THE LIKELIHOOD OF OR THE -- WHAT IS YOUR UNDERSTANDING OF THE FREQUENCY OF LAB ORDERS WITH RESPECT TO -- OF LAB ERRORS WITH RESPECT TO PSA TESTS OVERALL IN THE -- IN YOUR EXPERIENCE?
MARK BURNES: THE RESULT ITSELF, RARE.
MS. TREFZ: AND ARE YOU AWARE OF RESEARCH THAT'S SHOWN THAT THE RATE OF LAB ERRORS CAN VARY FROM .1 TO 3 PERCENT?
MARK BURNES: I HAVE NOT SEEN THAT.
MS. TREFZ: OKAY.
MARK BURNES: MY PERSONAL --
MS. TREFZ: GO AHEAD.
MARK BURNES: IF I COULD SPEAK TO THAT? I'M ALWAYS LOOKING FOR POSSIBLE LAB ERRORS FOR UNEXPECTED RESULTS, AND THEY HAVE OCCURRED, BUT THEY'RE VERY RARE.
MS. TREFZ: OKAY. ARE YOU AWARE OF THE VARIOUS REASONS THAT AN INACCURATE RESULT CAN BE PRODUCED?
MARK BURNES: YES.
MS. TREFZ: AND CAN YOU -- IS IT FAIR TO SAY THAT PREANALYTICAL PROCESSES, SUCH AS SAMPLE INTEGRITY ISSUES, COULD BE A SOURCE OF LAB ERROR?
MARK BURNES: YES.
MS. TREFZ: AND IS IT FAIR TO SAY THAT ANALYTICAL ISSUES, SUCH AS ERRORS IN THE REAGENT, COULD BE A SOURCE OF LAB ERROR?
MARK BURNES: YES.
MS. TREFZ: AND ARE YOU AWARE THAT SOMETIMES MANUFACTURERS OF COMMERCIALLY AVAILABLE REAGENTS AND EQUIPMENT ISSUE NOTICES INDICATING POTENTIAL ERRORS IN THEIR TESTS?
MARK BURNES: YES.
MS. TREFZ: AND ARE YOU AWARE THAT SOMETIMES THERE ARE ERRORS IN REPORTING?
MARK BURNES: YES.
MS. TREFZ: THE PSA TEST IS -- DO YOU UNDERSTAND THE METHOD BY WHICH IT'S TRADITIONALLY RUN IN TERMS OF THE TYPE OF CHEMISTRY THAT IS APPLIED?
MARK BURNES: NO. IF I DID ONCE, NO, I DON'T REMEMBER IT.
MS. TREFZ: IF I -- LET ME SEE IF I CAN JUST REFRESH YOU, AND IF NOT, THEN WE'LL MOVE ON. DO YOU RECALL WHETHER PSA IS OFTEN MEASURED BY IMMUNOASSAY?
MARK BURNES: NO, I DON'T RECALL.
MS. TREFZ: OKAY. AND ARE YOU AWARE -- DO YOU KNOW WHAT IMMUNOASSAY IS?
MARK BURNES: YES.
MS. TREFZ: AND ARE YOU AWARE OF -- THAT THERE CAN BE INHERENT EXPECTED IMPRECISION IN ASSAYS?
MARK BURNES: YES.
MS. TREFZ: AND DOES THAT INCLUDE IN IMMUNOASSAYS?
MARK BURNES: YES.
MS. TREFZ: AND BASED ON YOUR EXPERIENCE REVIEWING TEST RESULTS, INCLUDING PSA TEST RESULTS, DO YOU HAVE AN UNDERSTANDING THAT DIFFERENT APPROACHES TO MEASUREMENT CAN LEAD TO DIFFERENT RESULTS SOMETIMES?
MARK BURNES: YES.
MS. TREFZ: AND, IN FACT, HARMONIZATION OF RESULTS FROM DIFFERENT CLINICAL LABORATORY MEASUREMENT IS AN IMPORTANT CHALLENGE IN THE FIELD OF LAB SCIENCES, ISN'T IT?
MARK BURNES: COULD YOU RESTATE THE QUESTION?
MS. TREFZ: SURE. HARMONIZATION OF RESULTS FROM DIFFERENT CLINICAL LABORATORY MEASUREMENT PROCEDURES IS AN IMPORTANT CHALLENGE IN THE FIELD OF LAB TESTING; IS THAT CORRECT?
MARK BURNES: COULD YOU -- I'M HAVING TROUBLE UNDERSTANDING WHAT YOU MEAN BY "HARMONIZATION." CAN YOU USE A DIFFERENT WORD?
MS. TREFZ: SURE. WE MENTIONED A MINUTE AGO THAT DIFFERENT METHODS CAN SOMETIMES LEAD TO DIFFERENT RESULTS; RIGHT?
MARK BURNES: YES.
MS. TREFZ: AND ARE YOU AWARE OF EFFORTS TO TRY TO MAKE DIFFERENT METHODS -- OR UNDERSTAND THE RELATIONSHIP OF DIFFERENT METHODS SO THAT THEY CAN BE COMPARED?
MARK BURNES: YES.
MS. TREFZ: AND IS THAT AN IMPORTANT, IN YOUR UNDERSTANDING, SUBJECT OF RESEARCH IN THE FIELD OF LAB TESTING?
MARK BURNES: COULD YOU RESTATE THAT QUESTION?
MS. TREFZ: SURE. IS THIS EFFORT TO UNDERSTAND THE RELATIONSHIP BETWEEN DIFFERENT METHODS, IS THAT AN IMPORTANT AREA OF RESEARCH IN THE FIELD OF LAB TESTING?
MR. SCHENK: OBJECTION. BEYOND THE AREA IN WHICH HE WAS DESIGNATED AN EXPERT FOR OPINION PURPOSES.
JUDGE DAVILA: I THINK WE'RE A LITTLE BEYOND THAT. IT'S INTERPRETING THE RESULTS, AND THIS MIGHT GO TO THE SCIENTIFIC ANALYSIS. CAN YOU REPHRASE THAT QUESTION A LITTLE MORE?
MS. TREFZ: OKAY.
MS. TREFZ: YOU ALREADY STATED THAT YOU WERE AWARE THAT DIFFERENT METHODS CAN LEAD TO DIFFERENT RESULTS ON THE SAME ASSAY, OR THE SAME -- EXCUSE ME. LET ME TRY AGAIN. YOU ALREADY STATED THAT YOU'RE AWARE THAT DIFFERENT METHODS CAN LEAD TO A DIFFERENT RESULT ON THE SAME SAMPLE; CORRECT?
MARK BURNES: YES, BUT THEY SHOULD BE VERY SMALL VARIATIONS. THEY SHOULD HAVE STANDARDS OF THE NORMAL RANGE ATTACHED TO EACH RESULT.
MS. TREFZ: A REFERENCE RANGE ATTACHED?
MARK BURNES: A REFERENCE RANGE, YES.
MS. TREFZ: AND HAVE YOU TRIED TO COMPARE DIFFERENT -- WE CAN USE THE EXAMPLE OF PSA TESTS. HAVE YOU TRIED TO COMPARE DIFFERENT PSA TESTS TO EACH OTHER TO UNDERSTAND WHETHER THE RESULTS FROM DIFFERENT LABORATORIES ARE COMPARABLE OR NOT?
MARK BURNES: I HAVE NEVER APPROACHED IT FROM THAT POINT OF VIEW. I TRUSTED THAT THE LABS ARE VALID AND THE RESULTS, BASED ON THE REFERENCE RANGES STATED BY THE LAB.
MS. TREFZ: OKAY.
MARK BURNES: IF IT WAS WITHIN NORMAL RANGE OR OUTSIDE OF THE NORMAL RANGE. I JUST DON'T UNDERSTAND THE POINT WE'RE TRYING TO MAKE HERE.
MS. TREFZ: WELL, I BELIEVE YOU ANSWERED THE QUESTION, WHICH IS YOU BELIEVE THAT THERE SHOULD BE A SMALL DIFFERENCE AND THAT THERE SHOULD BE A REFERENCE RANGE?
MARK BURNES: A SLIGHT DIFFERENCE, YES.
MS. TREFZ: LET ME -- JUST FOR THE PURPOSES OF POTENTIALLY CLARIFYING FOR ALL OF US WHERE I'M GOING WITH THIS, LET ME HAND UP, IF I CAN, A COUPLE OF EXHIBITS. THEY'RE JUST GOING TO BE USED TO REFRESH YOUR RECOLLECTION, IF THEY DO. MAY I APPROACH, YOUR HONOR?
JUDGE DAVILA: YES.
BY MS. TREFZ:
MS. TREFZ: (HANDING.) DR. BURNES, I'VE HANDED YOU WHAT I'VE MARKED FOR IDENTIFICATION PURPOSES AS EXHIBITS 13689, 13690, AND 13691. AND WHAT I WOULD LIKE TO ASK IS WHETHER YOU CAN TAKE A LOOK IN PARTICULAR AT 13691. THE OTHER TWO EXHIBITS ARE PROVIDED FOR CONTEXT.
MARK BURNES: WHAT PAGE IS THAT?
MS. TREFZ: IT'S THE LAST ONE.
MARK BURNES: OH, I SEE.
MS. TREFZ: THE OTHER TWO EXHIBITS ARE PROVIDED FOR CONTEXT JUST SO THAT YOU UNDERSTAND.
MARK BURNES: WHERE IS THE REFERENCE NUMBER I'M LOOKING FOR ON THE PAGE?
MS. TREFZ: 13691. IT'S AT THE TOP RIGHT. AND IT'S A GREY -- THIS PARTICULAR EXHIBIT IS A ONE PAGE EXHIBIT, IT'S PRIMARILY GREY, AND IT HAS A WHITE BOX.
MARK BURNES: OH, YOU'RE TALKING ABOUT THIS ONE (INDICATING)?
MS. TREFZ: YES, THAT IS THE ONE THAT I'M PARTICULARLY INTERESTED IN. HOWEVER, I'VE PROVIDED THE OTHER TWO, WHICH ARE -- THESE ARE ALL FROM THE SAME WEBSITE BASICALLY. AND IF YOU CAN TAKE A READ OF THE 13691, AND I'M GOING TO ASK YOU A QUESTION ABOUT -- RELATED TO WHETHER IT REFRESHES YOUR RECOLLECTION ON A PARTICULAR ISSUE IN JUST A MOMENT.
MARK BURNES: OKAY. THIS PAGE STATES PROSTHETIC --
MS. TREFZ: I'M SORRY, DON'T -- BECAUSE WE'RE JUST USING IT FOR THIS PURPOSE OF REFRESHING YOUR RECOLLECTION, DON'T READ IT OUT LOUD. JUST READ IT TO YOURSELF.
(PAUSE IN PROCEEDINGS.)
MARK BURNES: I'VE FINISHED.
BY MS. TREFZ:
MS. TREFZ: AND MY QUESTION HERE IS, DOES THIS DOCUMENT REFRESH YOUR RECOLLECTION THAT PSA RESULTS ARE DIFFERENT -- FREQUENTLY DIFFERENT AMONG DIFFERENT MEASUREMENT PROCEDURES?
MARK BURNES: THEY CAN BE SLIGHTLY DIFFERENT.
MS. TREFZ: AND DO YOU UNDERSTAND THAT HARMONIZATION OF RESULTS IS CHALLENGING BECAUSE OF HOW THOSE PROCEDURES -- BECAUSE OF HOW PSA IS FREQUENTLY MEASURED?
MARK BURNES: I WOULD APPRECIATE IT IF YOU WOULD USE A DIFFERENT WORD THAN "HARMONIZATION." I'M NOT SURE WHAT YOU MEAN BY THAT. IS THAT CONSISTENT?
MS. TREFZ: WHAT I MEAN BY IT IS BRINGING THOSE TWO METHODS IN, YOU KNOW, UNDERSTANDING THE RELATIONSHIP BETWEEN THEM. I WAS USING THE LANGUAGE OF THE EXHIBIT FOR THAT PURPOSE, BUT --
MARK BURNES: OKAY. PLEASE RESTATE THE QUESTION.
MS. TREFZ: SURE. DO YOU UNDERSTAND THAT HARMONIZATION OF PSA RESULTS IS PARTICULARLY CHALLENGING BECAUSE THE WAY THAT IT'S MEASURED IS DIFFERENT IN DIFFERENT METHODS?
MARK BURNES: NO, NOT APPRECIABLY.
MS. TREFZ: OKAY. I, I --
MARK BURNES: MIGHT I EXPLAIN A LITTLE BIT? I DON'T WANT TO GO INTO TOO MUCH.
MS. TREFZ: SURE, GO AHEAD.
MARK BURNES: BUT FROM DIFFERENT LABS, THEY EXPECT SLIGHTLY DIFFERENT VALUES FOR THE SAME TESTS, BUT THEY SHOULD BE PRETTY CLOSE TO EACH OTHER. AND WHEN I'M TALKING ABOUT CLOSE, WITHIN ABOUT 5 TO 10 PERCENT OF THE VALUES. SO I WOULD NOT BE SURPRISED TO SEE SLIGHT VARIATION. FOR EXAMPLE, IF I DID A TEST SEPARATE FROM, COMPLETELY SEPARATE FROM THE PSA, SAY LIKE A SODIUM TEST, LIKE IT'S FROM THE SAME SAMPLE, FROM THE SAME PATIENT, TO TWO DIFFERENT LABS, ONE LAB MAY COME BACK AT 135 AND ONE MAY COME BACK AT 137, AND THAT WOULD BE AN EXPECTED VARIATION. BUT I WOULD NOT EXPECT IT TO BE 135 FOR ONE AND 120 WAY OUT OF RANGE ON THE SAME PATIENT. I WOULD EXPECT SOME VARIATION, BUT WITHIN REASON.
MS. TREFZ: OKAY. AND IS IT FAIR TO SAY THAT THE RANGE OF VARIATION YOU WOULD EXPECT IS DIFFERENT FOR DIFFERENT ANALYTES THAT ARE BEING MEASURED?
MARK BURNES: YES.
MS. TREFZ: AND YOU MENTIONED -- AND DO YOU HAVE AN UNDERSTANDING AS TO WHETHER -- STRIKE THAT. JUST TO UNDERSTAND PSA TESTS GENERALLY FOR ANOTHER MINUTE, ARE -- I THINK YOU TESTIFIED THAT IN THIS PARTICULAR CIRCUMSTANCE THE PATIENT WAS REQUESTED TO, REQUESTED TO HAVE THIS TEST BECAUSE -- BY HIS CHURCH; CORRECT?
MARK BURNES: YES.
MS. TREFZ: IN FACT, WITH PSA TESTS, ISN'T, ISN'T IT THE CASE THAT THERE'S ACTUALLY GUIDANCE THAT SUGGESTS THAT SOMETIMES THE BENEFITS OF DOING A PSA TEST CAN BE -- CAN OUTWEIGH -- OR SORRY. THE RISKS OF DOING THE PSA TESTS CAN OUTWEIGH THE BENEFITS?
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: SUSTAINED.
MS. TREFZ: MAY I --
JUDGE DAVILA: WELL, THE RISK OF THE TEST AND WHY, THE PURPOSE OF THE TEST BEING IS NOT REALLY AT ISSUE.
MS. TREFZ: WELL, HE'S BEEN OFFERED AS AN EXPERT ON PSA TESTS, AND THERE'S BEEN OTHER TESTIMONY IN THE CASE ABOUT PSA TESTS, SO I THOUGHT THIS WOULD BE AN OPPORTUNITY TO EXPLORE.
JUDGE DAVILA: HE'S AN EXPERT IN INTERPRETING PSA TEST RESULTS AND BLOOD TESTS FOR PSA AND DIAGNOSING PROSTATE CANCER. DOES YOUR QUESTION RELATE TO EITHER OF THOSE THREE?
MS. TREFZ: IT RELATES TO WHEN YOU RECOMMEND A PSA TEST AND HOW --
JUDGE DAVILA: WHY DON'T YOU ASK HIM THAT?
MS. TREFZ: OKAY.
MS. TREFZ: DR. BURNES, IS IT FAIR TO SAY THAT YOU DON'T ALWAYS RECOMMEND A PSA TEST FOR EVERY -- FOR EVERYONE ABOVE -- FOR EVERY MALE ABOVE 50?
MARK BURNES: NO. I DO RECOMMEND IT.
MS. TREFZ: YOU DO?
MARK BURNES: UNLESS THERE'S SPECIAL CIRCUMSTANCES. THE DEFAULT WOULD BE FOR MALES OVER 50 I WOULD DO IT ABOUT EVERY YEAR, YEAR AND A HALF.
MS. TREFZ: AND ARE YOU AWARE OF THE -- ARE YOU FAMILIAR WITH THE AMERICAN COLLEGE OF PHYSICIANS?
MARK BURNES: YES.
MS. TREFZ: AND YOU WERE PREVIOUSLY ACP CERTIFIED; IS THAT RIGHT?
MARK BURNES: I USED TO BE.
MS. TREFZ: AND IN APRIL 2013, ACP RELEASED A NEW PROSTATE CANCER SCREENING GUIDANCE. ARE YOU AWARE OF THAT?
MARK BURNES: YES.
MS. TREFZ: AND ISN'T IT THE CASE THAT THE GUIDANCE WAS THAT MEN BETWEEN THE AGES OF 50 AND 69 SHOULD DISCUSS THE LIMITED BENEFITS AND SUBSTANTIAL HARMS OF THE PROSTATE SPECIFIC ANTIGEN TEST WITH THEIR DOCTOR BEFORE UNDERGOING SCREENING FOR PROSTATE CANCER?
MR. SCHENK: OBJECTION. RELEVANCE.
JUDGE DAVILA: IT HAS SOME RELEVANCE, SO I'LL ALLOW HIM TO ANSWER THE QUESTION. DID YOU UNDERSTAND THE QUESTION, DOCTOR?
MARK BURNES: NO. I WAS GOING TO ASK HER TO REPEAT IT.
JUDGE DAVILA: SURE. LET'S DO THAT.
MS. TREFZ: SURE.
MS. TREFZ: YOU MENTIONED THAT YOU RECALLED THAT ACP RELEASED PROSTATE CANCER SCREENING GUIDANCE IN APRIL OF 2013.
MARK BURNES: YES.
MS. TREFZ: AND ISN'T IT THE CASE THAT THE FIRST LINE OF THAT GUIDANCE IS THAT MEN BETWEEN THE AGES OF 50 AND 69 SHOULD DISCUSS THE LIMITED BENEFITS AND SUBSTANTIAL HARMS OF THE PROSTATE SPECIFIC ANTIGEN TEST WITH THEIR DOCTOR BEFORE UNDERGOING SCREENING FOR PROSTATE CANCER?
MARK BURNES: I AGREE WITH THE DISCUSSION WITH THE PATIENTS, BUT I DISAGREE WITH THE RECOMMENDATION.
MS. TREFZ: OKAY. YOU DISAGREE WITH THE RECOMMENDATION, BUT YOU DON'T DISAGREE THAT THAT WAS THE RECOMMENDATION; IS THAT CORRECT?
MARK BURNES: THAT'S CORRECT.
MS. TREFZ: OKAY. DID YOU -- DID PATIENTS OF YOURS GO TO THERANOS AFTER THE INCIDENT WITH DR. ELLSWORTH?
MARK BURNES: POSSIBLY. I DON'T RECALL.
MS. TREFZ: OKAY. YOU DON'T RECALL ONE WAY OR THE OTHER?
MARK BURNES: NO, I DON'T RECALL.
MS. TREFZ: OKAY. AND DID THE GOVERNMENT ASK YOU AT ANY POINT FOR THE FULL LIST OF PATIENTS OF YOURS THAT, THAT WERE TESTED AT THERANOS?
MARK BURNES: NO.
MS. TREFZ: NO FURTHER QUESTIONS, YOUR HONOR.
JUDGE DAVILA: MR. SCHENK?
MR. SCHENK: I DO, YOUR HONOR.
REDIRECT EXAMINATION BY MR. SCHENK:
MR. SCHENK: DR. BURNES, I JUST WANTED TO FOLLOW UP ON A COUPLE OF QUESTIONS THAT YOU WERE JUST ASKED. THE FIRST AREA IS YOU READ SOME GUIDANCE ABOUT THE RISKS OF THE PSA TEST. DO YOU RECALL THAT?
MARK BURNES: YES.
MR. SCHENK: IS ONE OF THE RISKS THAT SOMEONE GETS A PSA TEST, IT IS HIGH, HIGH IS INACCURATE, AND THEN THEY TAKE SOME MEDICAL STEP, THEY INTERVENE SURGICALLY OR SOME OTHER WAY?
MARK BURNES: THAT IS CORRECT.
MR. SCHENK: SO THE TEST THAT I -- AND IF WE CAN BRING IT UP, ON PAGE -- IT'S EXHIBIT 4938, PAGE 7. IT'S ALSO ON THE SCREEN IF THAT'S EASIER FOR YOU. THIS IS THE MAY 14TH, 2015 TEST THAT DR. ELLSWORTH GOT. DO YOU RECALL THIS?
MARK BURNES: YES.
MR. SCHENK: SO THERANOS INFORMED YOU THAT DR. ELLSWORTH HAD A PSA SCORE OF OVER 26; IS THAT RIGHT?
MARK BURNES: YES.
MR. SCHENK: AND IS THE GUIDANCE THAT YOU WERE JUST PROVIDED WARNING DOCTORS FROM DOING PSA TESTS BECAUSE SOMETIMES YOU MIGHT GET AN ERRONEOUS TEST RESULT LIKE THIS, AND A DOCTOR MIGHT TAKE SOME UNNECESSARY MEDICAL INTERVENTION AS A RESULT OF THAT?
MARK BURNES: YES, IF THEY'RE NOT PAYING ATTENTION.
MR. SCHENK: PAYING ATTENTION TO WHAT?
MARK BURNES: REALLY IT'S THE TREND. I WANT TO KEEP MY EXPLANATION SHORT, BUT IT'S NOT THE TOTAL RESULT THAT IS SO IMPORTANT USUALLY. IT'S THE RATE OF CHANGE. SO YOU REALLY IDEALLY WANT TO HAVE TRACKING WITH PATIENTS ABOUT EVERY YEAR, YEAR AND A HALF OVER AGE 50, UNLESS THEY HAVE A HIGHER RISK DUE TO A FAMILY HISTORY, THEN WE START CHECKING IT EARLIER. AND THE PSA SHOULD GENERALLY SLOWLY RISE AS THE PROSTATE SLOWLY ENLARGES OVER THE YEARS, BECAUSE BASICALLY DEBRIS THAT IS EMITTED FROM THE PROSTATE INTO THE BLOOD, WHICH WE MEASURE, AND IT WILL SLOWLY RISE BECAUSE OF THE GROWTH OF THE GLAND. BUT IF YOU HAVE A METABOLICALLY ACTIVE PROCESS, SUCH AS CANCER, IT WILL GENERATE MORE DEBRIS, AND THAT'S THE THEORY ABOUT WHEN IT'S DEPOSITED IN THE BLOOD. AND THAT RISES HOW WE USE THE USEFUL MEASURE THAT ALLOWS US TO PICK UP PROSTATE CANCER YEARS BEFORE WE CAN FEEL IT ON EXAM OR BY DIAGNOSTIC IMAGING.
SO THERE'S A VALID RISK THAT IF YOU'RE NOT PAYING CLOSE ATTENTION TO YOUR PATIENTS, THAT IF YOU GET A TEST RESULT AND IT'S HIGH, YOU MIGHT UNNECESSARILY SEND A PATIENT FOR A BIOPSY, A PROCEDURE THAT HAS MORE RISK TO IT THAN SIMPLY DRAWING BLOOD, AND THIS IS TRUE. BUT THAT'S WHY -- BUT PSA'S ARE GENERALLY NEVER URGENT. IF I THINK THE RESULT IS CONCERNING BECAUSE OF A CHANGE, I'LL REPEAT IT IN TWO OR THREE MONTHS. IF IT'S A VERY SIGNIFICANT CONCERN, THEN I'LL SEND PEOPLE OFF TO A UROLOGIST FIRST. OR IT CAN ALSO BE AN ERROR -- WELL, MAYBE NOT ERROR, BUT INTERPRETED IMPROPERLY BECAUSE IT CAN BE ELEVATED DUE TO INFLAMMATION OF THE PROSTATE GLAND, WHICH IS CALLED PROSTATITIS, AND THAT WILL INCREASE THE VALUE AS WELL. SO, AGAIN, COMING BACK TO THE FACT THAT IT IS NOT URGENT, WE JUST LIKE TO PICK IT UP YEARS BEFORE IT'S TOO LATE TO DO SOMETHING ABOUT IT. WE HAVE TIME, OVER THE COURSE OF THE YEAR OR TWO MONITORING PSA'S, TO DECIDE AT WHAT POINT IN TIME YOU'RE GOING TO SEND PEOPLE FOR MORE INTERVENTION. DR. ELLSWORTH'S SITUATION WAS DIFFERENT BECAUSE HE WAS -- IT WAS VERY UNUSUAL BECAUSE HE WAS GOING TO BE LEAVING THE COUNTRY FOR TWO YEARS, SO WE WOULD LIKE -- IF THERE WAS AN ISSUE, WE WOULD LIKE TO HAVE CLARIFIED IT. THAT'S THE ONLY REASON FOR THE -- I WOULD HAVE REPEATED THE TEST ANYWAY, BUT I WOULD HAVE HAD A LITTLE MORE TIME. I WOULDN'T TAKE ANY ACTION UNTIL I FELT MORE ASSURED THAT WAS A VALID RESULT THAT WOULD WARRANT MORE INTERVENTION.
MR. SCHENK: I SEE.
MARK BURNES: THERE WAS NEVER ANY URGENCY FOR PSA.
MR. SCHENK: FORGIVE ME. I ALSO WANT TO ASK YOU A QUESTION ABOUT THE REFERENCE RANGE. YOU WERE ASKED SOME QUESTIONS ABOUT HARMONIZATION, ABOUT TESTS AT ONE LAB BEING COMPARED TO TESTS AT ANOTHER LAB. DO YOU REMEMBER THOSE QUESTIONS?
MARK BURNES: YES.
MR. SCHENK: ON THIS DOCUMENT, THERANOS PROVIDES A REFERENCE RANGE. DO YOU SEE THAT?
MARK BURNES: LESS THAN 4.0.
MR. SCHENK: SO WHAT DOES A SCORE OF 26 MEAN IN LIGHT OF THAT REFERENCE RANGE?
MARK BURNES: IT WAS, IT WAS ABNORMAL. BUT TO BE A LITTLE BIT MORE PRECISE, IN MY PRACTICE HOW I INTERPRET IT, IT'S THE RATE OF RISE. I'VE HAD PATIENTS WHO HAVE HAD PSA'S OF 18 THAT HAVE SLOWLY RISEN OVER THE YEARS THAT YOU MIGHT -- THAT I BIOPSIED THAT WERE MARKEDLY ELEVATED AND IT TURNED OUT IT WAS NEGATIVE. I'VE HAD PATIENTS THAT I HAVE DIAGNOSED WITH PSA OF 2.5 AS CANCER, BUT HIS VALUE HAD BEEN PRETTY STABLE AT LIKE 0.5, 0.6, 0.5, AND THEN THE FOLLOWING YEAR IT HAD A FIVE-FOLD RISE FROM .5 TO 2.5. BUT EVEN THOUGH THAT IS LESS THAN THE -- OR WITHIN THE NORMAL RANGE BY THE LAB STANDARDS, IT'S THE RATE OF RISE IS MORE IMPORTANT, AND THAT'S NEVER BEEN CHANGED ON THE LAB. THE RATE OF RISE IS WHERE YOU GET SUSPICIOUS.
MR. SCHENK: THANK YOU. NO FURTHER QUESTIONS.
MS. TREFZ: NO FURTHER QUESTIONS.
JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?
MS. TREFZ: HE MAY.
JUDGE DAVILA: THANK YOU. YOU CAN LEAVE THE DOCUMENTS THERE. THANK YOU. AND FEEL FREE TO TAKE THE MASK WITH YOU.
MARK BURNES: OH, THANK YOU.
JUDGE DAVILA: DOES THE GOVERNMENT HAVE ANOTHER WITNESS?
MR. SCHENK: WE DO, YOUR HONOR.
JUDGE DAVILA: IS THIS WITNESS -- WILL THIS BE A BRIEF WITNESS AS WELL?
MR. SCHENK: YES, YOUR HONOR.
JUDGE DAVILA: ALL RIGHT. THANK YOU. I SEE THIS IS THE TOP OF THE HOUR. SHOULD WE TAKE OUR BREAK NOW? IS THIS A GOOD TIME FOR OUR BREAK? LET'S DO THAT.
MR. SCHENK: YES.
JUDGE DAVILA: LET'S TAKE A 30 MINUTE BREAK NOW, LADIES AND GENTLEMEN, AND THEN WE'LL TAKE OUR NEXT WITNESS.
(RECESS FROM 11:01 A.M. UNTIL 11:38 A.M.)
JUDGE DAVILA: THANK YOU. WE'RE BACK ON THE RECORD. ALL PARTIES PREVIOUSLY PRESENT ARE PRESENT ONCE AGAIN. DOES THE GOVERNMENT HAVE A WITNESS?
MR. SCHENK: YES, YOUR HONOR. THE UNITED STATES CALLS MEHRL ELLSWORTH.
JUDGE DAVILA: GOOD MORNING, SIR. IF YOU WOULD COME FORWARD AND FACE OUR COURTROOM DEPUTY. IF YOU WOULD RAISE YOUR RIGHT HAND, SHE HAS A QUESTION FOR YOU.
MARK BURNES: GOOD MORNING.
COURT CLERK: GOOD MORNING.
(GOVERNMENT'S WITNESS, MEHRL ELLSWORTH, WAS SWORN.)
MARK BURNES: YES.
JUDGE DAVILA: I'LL INVITE YOU TO HAVE A SEAT UP HERE, SIR. MAKE YOURSELF COMFORTABLE. FEEL FREE TO ADJUST THAT CHAIR AND MICROPHONE AS YOU NEED. I'LL ENCOURAGE YOU TO SPEAK DIRECTLY INTO THE MICROPHONE. WHEN YOU ARE COMFORTABLE, I'D LIKE YOU TO STATE YOUR NAME AND SPELL IT, PLEASE. LET ME ASK YOU, HAVE YOU BEEN VACCINATED, SIR?
MARK BURNES: YES, AND INCLUDING THE BOOSTER.
(LAUGHTER.)
MARK BURNES: THREE OF THEM.
JUDGE DAVILA: THREE OF THEM. WELL, IF YOU WOULD LIKE TO TAKE YOUR MASK OFF WHILE YOU TESTIFY, YOU MAY DO SO.
MARK BURNES: I WOULD PREFER THAT.
JUDGE DAVILA: GREAT. AND MR. SCHENK WILL DO THAT AS WELL. WHEN YOU ARE COMFORTABLE, WOULD YOU PLEASE STATE YOUR NAME AND THEN SPELL IT, PLEAS.
MARK BURNES: MEHRL K. ELLSWORTH. M-E-H-R-L, K, ELLSWORTH, E-L-L-S-W-O-R-T-H.
JUDGE DAVILA: THANK YOU. COUNSEL.