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Clinical Pathologist Once Again at the Center of a National News Story as Theranos Founder Elizabeth Holmes Seeks New Trial

Federal judge must rule on her bid for a new trial, after former Theranos lab director Adam Rosendorff’s statement that he regrets his testimony during her criminal fraud trial

It is a rare event for a board-certified clinical pathologist to be named in national news headlines, but that is what is happening now to Adam Rosendorff, MD, who served as the CLIA laboratory director at Theranos for several years.

Rosendorff is once more the subject of news headlines because of his recent statements expressing “regret” about his testimony for the prosecution during the trial of Elizabeth Holmes, founder and ex-CEO of now defunct Theranos. This development caused attorneys for Holmes to file a motion for a new trial.

In August, Rosendorff showed up at the residence of Elizabeth Holmes and made statements to her attorneys that are the basis for the motion to conduct a new trial.

In a recent court filing requesting the new trial, Holmes’ attorneys described Rosendorff as a “star witness” for the prosecution and pointed out, “The government mentioned him more than any other government witness in both opening and closing statements, and Dr. Rosendorff testified longer than any other government witness.”

During four days of testimony last October, Rosendorff emerged as a central prosecution witness. On the stand, he supported prosecutors’ contention that Holmes knew about the accuracy issues with Theranos’ Edison blood-testing device and intentionally mislead investors and patients.

Dark Daily covered Rosendorff’s testimony in “Former Theranos Lab Director and Staff Testify in Ongoing Elizabeth Holmes Fraud Trial That They Voiced Concerns about Reliability and Accuracy of Edison Blood-Testing Device.”

Adam Rosendorff, MD

In court testimony, Adam Rosendorff, MD (above) said, “I had frequent conversations with Elizabeth about concerns that I had in the laboratory,” and [that] she was often copied on emails discussing issues, the Wall Street Journal reported at the time. As clinical laboratory leaders who closely followed his testimony know, Rosendorff was Theranos’ laboratory director from April 2013 to November 2014. (Photo copyright: LinkedIn.)

Rosendorff Attempts to Meet with Holmes

The “Dr. Rosendorff’s Encounter at Ms. Holmes’ Home” section of the 17-page filing states Rosendorff appeared at the home of Holmes and her partner William Evans on August 8 after leaving a voicemail earlier in the evening asking for a meeting with Holmes. Rosendorff allegedly had two short conversations with Evans, who told him Holmes could not speak to anyone and asked Rosendorff to leave. Rosendorff was described by Evans as speaking in a “trembling” voice and appearing to be “in distress.”

The filing goes on to state Rosendorff told Evans “that he wanted to speak to Ms. Holmes because it would be ‘healing for both himself and Elizabeth to talk.’ He stated that ‘when he was called as a witness, he tried to answer the questions honestly but that the prosecutors tried to make everyone look bad’ and that ‘the government made things sound worse than they were when he was up on the stand during his testimony.’”

The filing continues: “Dr. Rosendorff stated that ‘Theranos was early in his and [Ms. Holmes’] career,’ that ‘everyone was just doing the best they could,’ and ‘everyone was working so hard to do something good and meaningful.’”

The section concludes, “He stated that ‘he fe[lt] guilty’ and that he ‘felt like he had done something wrong,’ apparently in connection with his testimony in Ms. Holmes’ case. He stated that these issues were ‘weighing on him’ and that “he was having trouble sleeping.’”

Rosendorff’s Regrets Unlikely to Trigger New Trial

In the filing, Holmes’ attorneys wrote, “under any interpretation of his statements, the statements warrant a new trial under Rule 33. But, at a minimum … the Court should order an evidentiary hearing and permit Ms. Holmes to subpoena Dr. Rosendorff to testify about his concerns.”

According to the Federal Rules of Criminal Procedure, Rule 33, New Trial, newly discovered evidence is grounds for seeking a new trial. 

Bloomberg, however, quoted criminal defense attorney Michael Weinstein, JD, Chair of Cole Schotz P.C.’s White-Collar Litigations and Government Investigations Practice, as saying Rosendorff’s misgivings about his testimony are unlikely to warrant a new trial.

“A witness having second thoughts and how they were generally perceived is not new in criminal trials but often don’t lead to new trials or much of anything,” Weinstein told Bloomberg. “The burden for that is simply too high.” Weinstein was not involved in the Holmes case.

CBS News reached out to Rosendorff via LinkedIn, who responded he had no comment, adding, “Do not contact me.”

Nevertheless, Holmes’ lawyers have proposed an October 3 hearing to discuss why they believe a new trial is merited. Their request for a new trial came less than a week after U.S. District Judge Edward Davila rejected the defense team’s bid to have Holmes’ January convictions thrown out, the Mercury News reported.

“The evidence does support the jury’s findings,” Davila said at a September 1 hearing in San Jose, California, in which he issued a preliminary ruling denying her bid to have the verdict thrown out.

Theranos Saga Continues

At the hearing, Holmes’ lawyer Amy Mason Saharia, JD, told Davila the defense team would make another attempt to overturn the jury’s findings based on “new evidence,” the Mercury News stated. That new evidence appears to be Rosendorff’s admission that he has regrets about his testimony in the case.

Holmes, 38, is currently free on bail, but faces up to 20 years in prison and a fine of $250,000, plus restitution on each of four counts. She will be sentenced on October 17. The court originally set her sentencing date for September 26, but agreed to delay her sentencing without giving a reason for the delay, CBS News reported.

Will former Theranos laboratory director Adam Rosendorff, MD’s, regrets alter the court’s previous decisions? Who knows? Many clinical laboratory directors and medical laboratory scientists followed Elizabeth Holmes’ nearly four-month long fraud trial with rapt interest. They will now have to wait a few more weeks to find out if the disgraced Theranos executive will get a new trial or a prison sentence. 

Andrea Downing Peck

Related Information:

Theranos Founder Elizabeth Holmes Seeks New Trial over Alleged Regrets of Key Witness

USA vs. Elizabeth Holmes: Case No. CR-18-00258-EJD MS. Holmes’ Motion for a New Trial

Elizabeth Holmes Wants a New Trial Because a Prosecution Witness is Acting Remorseful

Elizabeth Holmes Seeks New Trial, Saying Key Witness Has Regrets

Former Theranos Lab Director Emerges as Central Prosecution Witness

Elizabeth Holmes Claims Witness Remorse in New Trial Request

Elizabeth Holmes Tries and Fails to Get Jury’s Fraud Verdict Thrown Out for Good

Court Delays Sentencing for Theranos Founder Elizabeth Holmes

Former Theranos Lab Director and Staff Testify in Ongoing Elizabeth Holmes Fraud Trial That They Voiced Concerns about Reliability and Accuracy of Edison Blood-Testing Device

Tale of Two Trials: Unlike Ex-Theranos CEO Elizabeth Holmes, COO/President Ramesh ‘Sunny’ Balwani Found Guilty of All Charges

Balwani’s lawyers opted not to have their client testify in his own defense and called only two witnesses, while Holmes’ defense team offered jurors the opportunity to hear her testimony

Elizabeth Holmes and Ramesh “Sunny” Balwani dreamed of revolutionizing the clinical laboratory blood-testing industry with their now defunct Theranos Edison device, which they claimed could perform multiple tests with a single finger prick of blood. Instead, they became the rare Silicon Valley executives to be convicted of fraud.

On July 7, ex-COO/President Balwani was convicted on all 12 counts of wire fraud and conspiracy charges in his federal fraud trial. Holmes, Theranos’ founder/CEO and former romantic partner to Balwani, avoided convictions six months ago in January on seven of the 11 counts she faced for her role in exaggerating the accuracy and reliability of the company’s Edison blood-testing device and providing false financial claims to investors.

“Once again, a jury has determined that the fraud at Theranos reached the level of criminal conspiracy,” said FBI Special Agent in Charge Sean Ragan in a press release posted on Twitter following the verdict. “The FBI has spent years investigating this investment fraud scheme with our partners at USPIS and the FDA Office of Criminal Investigations. Lies, deceit, and criminal actions cannot replace innovation and success.”

How did the trials differ? That’s the question many clinical laboratory directors and pathologists who followed Theranos’ legal saga may be asking, as well as how the Theranos trials reflect on their own duties under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Ramesh “Sunny” Balwani
 
Ramesh “Sunny” Balwani (above center), former COO/President of Theranos, is shown leaving the federal courthouse in San Jose, Calif., on July 7 after he was found guilty on all 12 counts of fraud, a verdict more severe than ex-CEO and Theranos founder Elizabeth Holmes received in January for similar charges. Clinical laboratory directors and medical laboratory scientists have been closely monitoring both trails. (Photo copyright: Jim Wilson/The New York Times.)

Balwani’s Age and Experience May Have Worked Against Him

Michael Weinstein, JD, a former Justice Department prosecutor who is the Chair of White-collar Litigation at Cole Schotz, told The New York Times that Balwani’s age and his trial date—three months after Holmes’ conviction—worked against him. Balwani, 57, could not present himself as a young and inexperienced tech executive easily manipulated by those around him, as Holmes, 38, had attempted to do.

“Holmes could come off as a bit naïve, and [her defense team] tried to sell that,” Weinstein said of the former Stanford University dropout who founded Theranos in 2003 when she was 19.

In Holmes’ case the verdict was mixed, with jurors acquitting her of the patient fraud counts but unable to reach a decision on some of the investor fraud counts, Bloomberg reported.

Mr. Balwani, however, “came off as more of an experienced technology executive,” Weinstein added.

Weinstein pointed out that because the government’s case against Balwani mirrored its case against Holmes, prosecutors had time to refine their strategy before making a second appearance inside US District Court Judge Edward Davila’s San Jose courtroom.

“The streamlined presentation, the streamlined evidence, the streamlined narrative—all was beneficial for the government in the end,” he said.

Ever since opening arguments in March, Balwani’s legal team portrayed him to the jurors as a loyal partner who believed in Theranos’ technology and “put his money where his mouth is,” the Guardian noted.

Prosecutors, however, made the case that Balwani had a hands-on role in running the lab and was the source of Theranos’ overinflated financial projections.

Balwani invested about $15 million in the startup between 2009 and 2011 and never cashed in when his stake grew to $500 million. That money evaporated when Theranos collapsed.

In all, 24 witnesses testified against Balwani. He was ultimately convicted of all 12 counts he faced:

  • Two counts of conspiring with Holmes,
  • Six counts of defrauding investors, and
  • Four counts of patient fraud.

Major Differences in Trial Testimony

The Balwani trial made headlines due to COVID-19 pandemic related delays, but otherwise did not produce the news-generating moments that punctuated Holmes’ nearly four-month-long court appearance. Thirty-two witnesses appeared at the Holmes trial, including Secretary of Defense James Mattis, according to CNN.

Another significant difference in the two trials was that Holmes testified in her own defense. Holmes spent nearly 24 hours on the stand, CNN Business noted at that time, during which she cast the blame for Theranos’ failings on those around her, including Balwani.

In one of her trial’s most dramatic moments, a tearful Holmes accused Balwani of emotional and sexual abuse, including forcing her to have sex, which Dark Daily covered in “Balwani and Holmes’ Personal Relationship Takes Center Stage in Criminal Trial, Fueling Continued Public Interest in Theranos Fraud Saga.” Balwani denied those allegations.

ABC News Rebecca Jarvis, host and creator of the podcast “The Dropout,” believes Balwani’s decision not to testify worked against him.

“[The abuse claims] did not come up at his trial, but during [Holmes’] seven days of testimony, they were a big portion of what she talked about,” Jarvis said in an ABC NewsStart Here” podcast. “The biggest difference is that he didn’t take the stand to say, ‘I didn’t do this,’ or … raise his own objections to the claims against him.

“You think about a jury who is supposed to know nothing about any of [the defendant’s] backstory, and they’re shown these things like … case pictures of [Holmes] so much younger than [Balwani], supposedly having to rely on him for his expertise,” Jarvis added.

“You can imagine where the jury may have found that presentation more sympathetic than Sunny Balwani who had experience,” she said.

Text May Have Been Balwani’s Undoing

Balwani’s defense team called only two witnesses:

  • A naturopathic physician who used Theranos’ blood-testing lab, and
  • A technical consultant who Balwani’s legal team hired to assess the accessibility of patient data in Theranos’ Laboratory Information System (LIS), which the defense argued could have provided evidence of the accuracy of Theranos’ test results.

Attorney Jennifer Kennedy Park, JD, a partner at Cleary Gottlieb, told Yahoo Finance the LIS database may have played a role in the jury’s verdict as well.

“This verdict also signals the jurors did not buy Balwani’s highly speculative argument that the database Theranos lost in 2018 would have proven his innocence,” Park said.

In a statement to CNN Business, Balwani attorney Jeffrey Coopersmith, JD, of Orrick, Herrington and Sutcliffe, LLP, said the defense is exploring avenues to possibly fight the jury’s decision.

“We are obviously disappointed with the verdicts,” he said. “We plan to study and consider all of Mr. Balwani’s options including an appeal.”

Following the verdicts, Judge Davila raised Balwani’s bail to $750,000 and set a Nov. 15 sentencing date. Holmes is scheduled to be sentenced Sept. 26.

Balwani’s own words may have been his final undoing. During closing arguments, prosecutors again showed jurors a text message Balwani sent to Holmes in 2015, The New York Times reported.

“I am responsible for everything at Theranos,” he wrote. “All have been my decisions too.” 

Clinical laboratory directors and medical laboratory scientists will no doubt continue to monitor the fallout from these two extraordinary federal fraud trials. There’s still much to learn about CLIA-laboratory director responsibility and how the government plans to prevent future lab testing fraud from taking place.

Andrea Downing Peck

Related Information:

Tweet: FBI San Francisco

Theranos Trial: Legal Saga Reaches Final Chapter as Sunny Balwani Faces Verdict

No. 2 Theranos Executive Found Guilty of 12 Counts of Fraud

The Key Moments from Elizabeth Holmes’ Trial

Theranos Ex-President Balwani Found Guilty of Fraud

ABC: Start Here Podcast

Theranos: Elizabeth Holmes Co-Defendant Sunny Balwani Found Guilty of All 12 Counts

Former Theranos COO Is Guilty of Federal Fraud

Closing Statements Made in Trial of Sunny Balwani

Theranos Trial: Legal Saga Reaches Final Chapter as Sunny Balwani Faces Verdict

Former Theranos President’s Defense Rests in Criminal-Fraud Trial

Former Theranos Executive Sunny Balwani’s Fraud Trial Heads to Jury

Federal Fraud Trial of Former Theranos President/COO Ramesh ‘Sunny’ Balwani Postponed until June 7

No explanation for the delay was provided by court after nine weeks of testimony in the prosecution of the former clinical laboratory executive

Former Theranos president/chief operating officer Ramesh “Sunny” Balwani’s often-delayed fraud trial was scheduled to resume on May 27 with a full day of defense witness testimony. It will now be delayed until June 7.

According to NBC Bay Area, a court assistant announced the delay but did not provide a reason for the postponement. A copy of the clerk’s notice posted on Twitter by Law360 also provided no further details. Pathologists and clinical laboratory managers must now wait several more months to learn what may be next revealed in testimony during this trial.

It is also yet one more delay in Balwani’s trial. His original trial date was January 2022 before being rescheduled for February. The needs for COVID-19 pandemic protocols further delayed the start multiple times until opening arguments began March 22 in a federal court room in San Jose, Calif.

One part of the trial has concluded. On May 20, the government rested its case against Balwani, who faces 12 counts of wire fraud and conspiracy to commit wire fraud while serving as second in command at Theranos, the now defunct Silicon Valley medical laboratory startup.

Ramesh “Sunny” Balwani
Former Theranos president and COO Ramesh “Sunny” Balwani (above) faces 12 charges of wire fraud and conspiracy to commit wire fraud while serving as chief operating officer of Theranos, the company that boldly declared it would disrupt the clinical laboratory testing industry. His trial, which began in March in US District Court in San Jose, Calif., is now delayed until June 7, when his defense attorneys will begin their first full day of witness testimony. (Photo copyright: Stephen Lam/Reuters/The New York Times.)

According to The Wall Street Journal (WSJ), nine weeks of testimony in US District Court in San Jose, Calif., included testimony from 24 witnesses. Prosecutors aimed to convince jurors Balwani controlled much of the day-to-day decision-making at Theranos and was a full participant in the fraud scheme.

NBC Bay Area stated prosecutors worked to link Balwani to two key decisions:

  • The rollout of the failed Edison blood testing device in Walgreens, and
  • The company’s improper use of the Pfizer logo on a report to Walgreens executives that appeared to validate Theranos’ technology.

Before this latest postponement, Balwani’s attorneys had begun their client’s defense by putting a naturopathic physician from Arizona on the stand. The witness testified to sending more than 150 patients to Theranos and to using the company’s blood tests for herself, the WSJ reported.

In addition, Jeffrey Coopersmith, JD, one of Balwani’s attorneys and Partner at Orrick Herrington and Sutcliffe, LLP, made a verbal motion for an acquittal at the conclusion of the government’s case, which the judge deferred.

Prosecution Strategy Angers Theranos Customers

Bloomberg reported that prosecutors followed the previous outline used to gain the conviction of Elizabeth Holmes, founder and former CEO of Theranos, with many of the same witnesses from her trial reappearing on the stand to testify in the Balwani trial.

Prosecutors primarily focused their case on the injury to investors, which has angered some former Theranos customers.

“I feel like I belong to a group of people who were on the receiving end of a crime,” said Erin Tompkins—a Theranos customer who testified against both Holmes and Balwani—outside the courthouse shortly after finishing her testimony in the Balwani case, Bloomberg reported.

According to CNBC, Tompkins testified she was misdiagnosed as having HIV after having her blood drawn from a Theranos device at a Walgreens in Arizona.

“Despite the dedication and support of prosecutors, patient witnesses have been treated as peripheral” compared to the investors, Tompkins told Bloomberg. “We were defrauded because we trusted them with our blood and however many dollars for the test. But we weren’t robbed of millions of dollars.”

Susanna Stefanek, editorial manager at Apple Inc. who served on the Holmes jury, told Bloomberg, “[The prosecution] didn’t really prove that these patients were persuaded to get these blood tests by something she said or did, or even the advertising. The connection between Elizabeth Holmes and the patients was not that strong to us.”

Proving Patient Fraud

Michael Weinstein, JD, a former federal prosecutor turned Chair of White-Collar Litigation and Government at Cole Schotz in New Jersey, told Bloomberg that to convict Balwani of patient fraud, prosecutors must prove Balwani knew what was going on inside Theranos and that his misrepresentations caused patients to suffer.

“The government wants to show there was an inconsistency between what he was learning internally versus what he was saying externally,” Weinstein said.

With the Balwani trial likely to conclude this month, clinical laboratory directors and pathologists who have closely followed Theranos’ rise and fall should prepare for the final chapter in the saga. 

Andrea Downing Peck

Related Information:

Sunny Balwani Trial Postponed Until June 7: Court

Did Sunny Balwani Make Decision to Use Pfizer Logo When Promoting Theranos?

Former Theranos Patient Testifies That a Blood Test at Walgreens Came Back with False Positive for HIV

Prosecution Rests in Trial of Former Theranos President Ramesh “Sunny” Balwani

Elizabeth Holmes Beat Charges of Patient Fraud. Will Ramesh “Sunny” Balwani?

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