The federal trial, now set to begin in March 2021, could become a media spectacle given the marquee names on the witness list
Clinical laboratories following the federal criminal proceedings against Theranos founder and former CEO Elizabeth Holmes will have to wait until next year for the case to go to trial. When it does, it could become a media spectacle given the list of prominent witnesses who may be called as government witnesses.
The names, according to a letter that prosecutors sent April 3 to Holmes’ defense team, include former US Cabinet Secretaries Henry Kissinger and James “Mad Dog” Mattis, both of whom sat on the board of the ill-fated diagnostics company. Prosecutors may also call media mogul Rupert Murdoch to testify, the (San Jose) Mercury News reported.
To Fingerstick or Not to Fingerstick
As readers of Dark Daily will recall, Holmes claimed that Theranos had developed ground-breaking blood-testing technology that allowed for a range of blood tests using only 25 to 50 microliters of blood drawn by fingerstick rather than conventional venipuncture. Use of capillary specimens for many clinical laboratory tests was regularly touted by Holmes as one of Theranos’ technology secrets and a key to its plans to disrupt the clinical laboratory marketplace.
But then a series of articles by The Wall Street Journal (WSJ) in the fall of 2015 revealed serious problems with Theranos’ management and technology, eventually leading to the company’s downfall.
Charges of Fraud
According to documents filed with the US Department of Justice (DOJ) US Attorney’s Office Northern District of California, on June 15, 2018, a federal grand jury indicted Holmes and Theranos president Ramesh Balwani with 11 counts related to wire fraud. The government alleges one scheme to defraud investors and another to defraud doctors and patients. The defendants each face up to 20 years in prison for each count plus fines and restitution. They have pleaded not guilty.
“Holmes and Balwani used advertisements and solicitations to encourage and induce doctors and patients to use Theranos’ blood testing laboratory services, even though, according to the government, the defendants knew Theranos was not capable of consistently producing accurate and reliable results for certain blood tests,” the government stated in an announcement of the indictment. “It is further alleged that the tests performed on Theranos technology were likely to contain inaccurate and unreliable results.”
Prosecutors later added a 12th felony charge tied to a patient’s blood-test result, as Dark Daily reported in July. That charge was later withdrawn and then restored amid legal wrangling about the composition of the grand jury.
The start of the trial has been delayed twice due to the COVID-19 pandemic. Jury selection is now set to begin March 9, 2021, the East Bay Times reported.
Witnesses for the Prosecution
Dark Daily has reviewed the April 3 letter sent by prosecutors to the defense team. It lists witnesses and documents that may be used as evidence in the case. The defense attorneys included the letter in a June 30 filing indicating that they will seek to exclude or limit much of the prosecution evidence.
The April 3 letter “did not identify the particular acts Ms. Holmes supposedly committed and continued to rely on vague themes,” they wrote. “It did not disclose what evidence the government would introduce outside its case in chief. And it did not provide any explanation of which particular acts the hundreds of witness statements and the thousands of pages of discovery it identified would support.”
One section, with the heading “False and misleading representations made to Theranos’ Board of Directors,” includes the following former board members as possible witnesses:
William Perry, US Secretary of Defense in the Clinton Administration.
Robert Shapiro, an attorney best known as a member of the defense team in the O.J. Simpson murder trial.
George Shultz, US Secretary of State in the Reagan Administration and US Secretary of the Treasury in the Nixon Administration.
The letter also indicates that some of these former board members could be called to testify about alleged efforts by defendants Holmes and Balwani to conceal a romantic relationship, as well as alleged efforts by the defendants to avoid subjecting Theranos technology to “meaningful comparative tests.”
Murdoch, executive chairman of News Corp., is one of six potential witnesses who may be called to testify about “threats, influence, or vilification of journalists in response to negative coverage with Theranos.” News Corp. is the parent company of The Wall Street Journal.
Another section relates to alleged “false and misleading representations made to journalists.” It references articles published in Wired, Fortune, CNN, The Economist, Medscape, and The New Yorker.
Other sections of the letter offer a broader picture of the government’s case against Holmes and Balwani. It lists potential witnesses and documents related to the following subjects, though some names have been redacted:
False and misleading representations directed at insured patients.
False and misleading representations directed at doctors.
False and misleading representations made to Walgreens.
False and misleading representations made to Safeway.
Restricting access to laboratory areas within Theranos.
Harassing, threatening, or otherwise influencing doctors or patients who had negative experiences with Theranos.
Blaming and vilifying competing companies.
Threatening or intimidating employees and former employees.
False and misleading representations made to FDA, CMS, CDPH, and other regulatory organizations.
Violations of industry standards and government regulations or rules regarding research and development procedures, medical devices, and clinical laboratory practices.
Altering or tampering with third-party medical devices.
Obtaining personal benefit from position at Theranos.
One interesting aspect to the rise and fall of Elizabeth Holmes and Theranos is that the clinical laboratory and anatomic pathology professions were never fooled by all the publicity and news coverage of the company. Pathologists and clinical laboratory scientists knew that, over the 10-plus years of Theranos’ existence, its scientific team had never published any research findings of significance in a respected, peer-reviewed journal.
That was strong evidence that Theranos had no new break-through, disruptive, diagnostic technologies that would allow it to perform multiple tests on a single drop of blood that was collected by a fingerstick procedure.
Since the collapse of Theranos and the downfall of Elizabeth Holmes, many in the clinical laboratory profession have hoped that federal prosecutors would prosecute her under the full extent of the law.
Holmes’ lawyers maintain the former CEO of Theranos has not waived right to be charged by indictment and therefore argue the added charge is ‘unconstitutional’ and should be dismissed
Clinical laboratory leaders needing a break from nonstop coronavirus pandemic news will be interested to learn a familiar name is again making headlines. Disgraced Theranos founder Elizabeth Holmes—who went from paper billionaire to criminal defendant—is now facing a 12th felony fraud charge, with the additional count tied to a patient’s blood-test result.
Holmes founded the blood testing company in 2003 after dropping out of Stanford University. Though Theranos reached a peak valuation of $9 billion in 2015, according to Investopedia its unicorn-startup status began unraveling that same year when a Wall Street Journal (WSJ) investigation exposed the company’s massive deceptions and questionable practices related to its finger-prick blood-testing technology.
Holmes and codefendant Ramesh “Sunny” Balwani, former Theranos President and Chief Operating Officer, claimed Theranos had developed a medical technology that could run thousands of clinical laboratory tests using a finger-prick blood test that would return results in two hours and at a price that was 50% of Medicare’s fees for lab tests.
sanctions from the Centers for Medicare and Medicaid Services, investor lawsuits, consumer lawsuits, and a settlement with Walgreens over claims about Theranos’ Edison portable blood analyzer, CNBC reported. Theranos ceased operations in September 2018.
The 12th Felony Charge Against Elizabeth Holmes
Earlier in 2018, David L. Anderson, US Attorney for the Northern District of California indicted Holmes and Balwani on 11 counts of wire fraud and conspiracy to commit wire fraud.
Now, an additional wire fraud charge has been added to that list. The 12th felony charge was included in Superseding Information federal prosecutors filed with the court on May 8. Superseding Information is a charging document that does not require a grand jury proceeding.
In the filing, the latest allegation of fraud is alleged to have occurred on October 12, 2015, in the states of California and Arizona and is described as a “telephone call from Patient B.B. to Theranos regarding laboratory blood test results.”
The Superseding Information states: “Knowing that the accuracy and reliability of Theranos test results was questionable and suspect, Holmes and Balwani oversaw the electronic wiring of test results to patients, including persons known to the Attorney for the United States as Patients B.B, E.T., and M.E. These wires … travelled between one state and another.”
The amended charging document also more than doubles the length of time the pair are alleged to have conspired to defraud investors, adds additional categories of alleged victims, and revises the dates of two of the other prior wire fraud charges, changing them from 2014 to 2015.
“In particular, Holmes and Balwani knew that Theranos was not capable of consistently producing accurate and reliable results for certain blood tests, including but not limited to bicarbonate, calcium, chloride, cholesterol/HDL/LDL, gonorrhea, glucose, HbA1c, hCG, HIV, LDH, potassium, PSA, PT/INR, sodium, testosterone, TSH, vitamin D (25-OH), and all assays conducted on Theranos’ TSPU [Theranos Sample Processing Unit] version 3.5, including estradiol, prolactin, SHBG, thyroxine (T4/free T4), triiodothyronine, and vitamin B-12,” the Superseding Information states.
According to Law.com, Holmes’ lawyers at Williams and Connolly responded by filing a motion to dismiss the Superseding Information. Because grand jury proceedings have been suspended in the Northern District of California since mid-March due to COVID-19, they argue that Holmes, who hasn’t waived the right to be charged by grand jury indictment, is unable to be arraigned. They maintain the prosecutors’ actions violate her rights under the US Constitution and Federal Rules of Criminal Procedure Rule 7, which requires crimes punishable by a prison sentence of more than a year to be charged by indictment unless the defendant waives that right.
“Because Ms. Holmes does not waive prosecution by indictment, convening an arraignment on this information would be pointless and a waste of the Court’s time because no arraignment could actually occur,” her lawyers wrote in their motion. “The Court should dismiss this unconstitutional information without scheduling an arraignment.”
On May 26, prosecutors filed their opposition to the defendants’ motion to dismiss. They maintained that US District Judge Edward Davila should either deny the defense request outright or hold off ruling until a “reasonable time after the Court lifts the suspension of grand jury hearings.”
They wrote, “Defendants’ claim that an information must be ‘dismissed immediately’ because it is not the constitutionally required indictment proves too much,” adding, “Criminal charges are initiated all the time through preliminary proceedings like a complaint or an information. They are not ‘patently unconstitutional merely because a defendant has indicated she will not waive her right to be prosecuted by indictment.”
COVID-19 Delays Court Proceedings
Holmes’ trial originally was set to begin in August, but the COVID-19 pandemic has resulted in the case being postponed to October 27, reported CNBC. According to Davila, “We’re in unchartered waters and unchartered territories. We need to make sure the environment is safe for all parties, including the jury that’s called to hear the matter.”
The Theranos scandal continues to serve as a reminder to clinical laboratory leaders
and pathology groups that questionable or deceptive business practices eventually will draw the attention of federal regulators, prosecutors, and consumers, and that the penalty for fraud can be severe. The frustration for medical laboratory professionals and pathologists is that it generally takes years for federal investigators to bring charges against such frauds.
Fawning media coverage Theranos’ blood-test claims ended once experts spoke out, showing the importance of strong relationships between pathologist and journalists
Wall Street Journal (WSJ) reporter John Carreyrou’s investigation into former Silicon Valley darling Theranos is credited with turning the spotlight on the blood-testing company’s claims and questionable technology. However, Carreyrou’s investigation may never have happened without the assistance of Missouri pathologist Adam Clapper, MD, who tipped off the reporter to growing skepticism about Theranos’ finger-stick blood testing device.
Clapper’s involvement in Theranos’ fall from grace provides
a lesson on why anatomic
pathologists, clinical
pathologists, and other medical
laboratory leaders should cultivate strong working relationships with
healthcare journalists who seek out expert sources when covering lab-related
issues.
Dark Daily has written extensively about Theranos—once valued at nine billion dollars—and its founder and former CEO Elizabeth Holmes, whose criminal trial on nine counts of wire fraud and two counts of conspiracy to commit wire fraud is scheduled to begin this summer, noted the WSJ.
In 2018, Holmes and former Theranos President Ramesh “Sunny” Balwani settled a civil case with the Securities and Exchange Commission (SEC). Holmes agreed to pay a $500,000 penalty and relinquished control of Theranos. She also was barred from serving as Director of a public company for 10 years.
Theranos Investigation Would Not Have Occurred without
Clapper
Holmes founded Theranos in 2003 when she was 19 years old.
By 2013, Holmes had become a media sensation based on her claims that Theranos
had developed a medical technology that could run thousands of clinical
laboratory tests using the blood from a tiny finger-prick. And, she claimed, it
could do so quickly and cheaply.
By 2015, Carreyrou’s exposé in theWall Street Journal revealed Theranos’ massive deceptions and questionable practices. His series of stories kickstarted the company’s downfall. However, Carreyrou acknowledges his investigation would not have occurred if it were not for pathologist Clapper.
“Without Adam Clapper, I am almost 100% sure that I wouldn’t have done anything,” Carreyrou told the Missourian. “It was the combination of him calling me and telling me what he had found out and how he felt and my feelings about the New Yorker story that really got me on the call of this scandal,” he said.
According to the Missourian, Clapper turned to
Carreyrou because the reporter had impressed him as “very fact-oriented and
fact-driven” during telephone interviews for a series Carreyrou had written the
year prior on Medicare fraud.
“I could hear his wheels spinning in his head as we were
talking the first time, then he definitely sounded interested and intrigued,”
Clapper told the Missourian. “And then I could tell he was even more so
because very soon thereafter—like half an hour after that initial
conversation—he’d already started to do some research into Theranos.”
Ten months later, the WSJ published Carreyrou’s first
installment of his series on Theranos.
“The fact that this tip originated from a guy in Columbia,
Missouri, thousands of miles from Silicon Valley—who never spoke to Elizabeth
Holmes, who had no connection to the company or even to Silicon Valley other
than he read about her claims in a magazine and knew a lot about this by virtue
of being a pathologist—tells you that the people who put in all the money in [Theranos]
didn’t spend enough time talking to experts and asking them what was feasible
and what wasn’t,” said Carreyrou.
The lawyers defending Holmes against criminal fraud charges are contending Carreyrou “went beyond reporting the Theranos story” by prodding sources to contact federal regulators about the company’s alleged frauds and “possibly biased the agencies’ findings against [Theranos],” Bloomberg News reported.
Carreyrou told New York Magazine he doesn’t blame reporters for hyping Holmes and the technology she touted.
“You could make a case that maybe they should have done more
reporting beyond interviewing her and her immediate entourage,” he said. “But
how much is a writer/reporter to blame when the subject is bald-face lying to
him, too?”
Nonetheless, the Theranos scandal offers a lesson to
pathologists and clinical laboratory professionals in the importance of
building good working relationships with healthcare journalists who not only
must accurately report on healthcare breakthroughs and developments, but also
need someone they can trust for an unbiased opinion.
If direct-to-consumer testing continues to attract healthcare consumers and financial investors, medical laboratories could have a new source of revenue
Many have tried but few have found the right formula to
offer medical laboratory tests directly to consumers. Direct-to-consumer lab
testing as a robust business model has been an elusive goal. But now one
entrepreneur wants to crack this market and just attracted $50 million in
venture capital to fund her idea!
Outsiders often establish industries. This was the case when Jeff Bezos created Amazon in 1994. The online retailer transformed the way books were sold and, subsequently, established a massive new retail market.
Along the same lines, Julia Taylor Cheek, Founder and CEO of EverlyWell, a well-financed digital health company based in Austin—hopes to build a similarly disruptive business in the clinical laboratory industry.
Cheek is increasing her company’s outreach to consumers by
putting some of the company’s direct-to-consumer (DTC) medical tests on store
shelves at CVS and Target.
A former consultant and Harvard Business School graduate, Cheek raised $50 million in financing to expand EverlyWell’s digital platform. According to a news release, “Just two full years into operation, EverlyWell is reporting 300% year-over-year customer growth and a world-class consumer Net Promoter Score (NPS).”
“I think it’s a representation of sexism in our space. There are 15 other companies that have popped up in blood testing and you don’t hear anyone comparing Theranos to those male-founded startups,” she told Inc.
However, Dark Daily believes Cheek may be missing one
basis for the comparison with Elizabeth Holmes. Holmes intended for Theranos to
serve consumers with lab testing, and let consumers order and purchase their
own medical laboratory tests. Cheek is talking about the same primary business
strategy of letting consumers purchase their own lab tests.
Armed with this additional financing from investors, EverlyWell intends to expand services and develop new partnerships with retail pharmacy chain CVS Health (NYSE:CVS) and for-profit insurance company Humana (NYSE:HUM).
The news release notes, “The company has also expanded its
product line to offer 35 panels, including first-to-market tests in fertility,
vitamins, peri- and post-menopause, and high-risk HPV. In addition, EverlyWell
has launched an end-to-end care model for consumers, now offering an
independent physician consult and prescription, if appropriate, for select STDs
and Lyme Disease testing. All of this is included in an upfront price before
purchase.”
EverlyWell Intent on
Bringing Medical Laboratory Tests to Retail
Earlier this year, EverlyWell made nine lab tests available in more than 1,600 Target store locations, MedCity News reported. This may suggest that retailers are intrigued with direct-to-consumer lab testing.
Cheek reportedly established EverlyWell after becoming
disenchanted with medical laboratory tests that she felt were not well
explained and too costly under high-deductible health plans.
Just two years on, EverlyWell reports “hundreds of thousands of customers and tens of millions in sales.” The company plans to add additional staff on top of its existing 70 employees in anticipation of the new funding, Austin Business Journal reports.
“We are building a consumer brand, which means we have to be where people shop. We need to be in places like CVS and Target to really allow for broader distribution and name recognition,” Cheek told the Austin American-Statesman.
What Draws People to EverlyWell?
EverlyWell offers home health test kits, priced from $49 to
$400 that people can order without a doctor’s prescription and pay for online. Users
take their samples (saliva, urine, or a pinprick of blood) with provided
lancets and cotton swabs, MedCity News
reported.
EverlyWell’s top selling tests are:
Food sensitivity-$159;
Thyroid function-$159;
Metabolism-$89; and
Vitamin D deficiency-$99.
EverlyWell says it is “first” in direct-to-consumer tests
for:
EverlyWell Test kits come with registration information, instructions, collection tools;
Biological samples are sent by consumers to CLIA (Clinical Laboratory Improvement Amendments)-certified labs that partner with EverlyWell;
Results are generally completed within 10 days depending on type of test and business volume;
A physician reviews the test results;
Reports on test results are electronically accessible through smartphone apps and online web dashboards.
“Lab testing is arguably one of the most important steps in preventing and managing illness but has been largely ignored by digital health companies. EverlyWell is successfully navigating an entrenched industry to offer consumers an opportunity to take charge of their own health,” said Eric Kim, Managing Partner at Goodwater Capital (which led the financing), in the news release.
“We’re building the definitive technology-enabled healthcare platform that consumers deserve and have already come to expect in other areas of their lives,” Cheek told VentureBeat. “As high-deductible plans become the norm, consumers are becoming discerning buyers who look for seamless, digitally enabled experiences.”
Learning from
EverlyWell
Of course, pathologists and medical laboratory professionals
will watch to see if EverlyWell can sustain its rapid rise in popularity with
healthcare consumers. In particular, those consumers who prefer DTC testing
over traditional clinical laboratory visits and who may be on high-deductible
health plans.
The DTC test market represents an opportunity that most
clinical laboratories have yet to take seriously. There are many reasons why
medical lab managers and pathologists would be taking a “wait and see”
attitude. Meanwhile, EverlyWell has $50 million of investors’ money to use to
demonstrate the financial viability of its strategy to encourage consumers to purchase
their own clinical laboratory tests—and even collect their own specimens at
home!
Defamation, libel, harassment, and causing emotional distress are some of the charges patients who launched online negative review campaigns are defending themselves against in court
Healthcare systems, surgeons, family practitioners, clinical laboratories, anatomic pathologists—none are immune to receiving negative online reviews from patients who believe they’ve been damaged by their caregivers. And these reviews can have such an impact on practice revenues, doctors and hospitals have begun suing patients for damages caused by harmful online reviews. And they are winning.
Several notable cases involve high-profile healthcare systems. One such lawsuit involved the Cleveland Clinic. A patient who claimed a 2008 prostate surgery left him impotent and incontinent due to negligence on the part of the surgeon launched a negative campaign that spanned a decade, USA Today reported.
David Antoon, a retired Air Force Colonel, filed a malpractice lawsuit against urologist, Jihad Kaouk, MD, and the Cleveland Clinic. Antoon alleged Kaouk was not present in the operating room during his surgery, even though he insisted that only Kaouk perform the procedure. Antoon also claimed the Cleveland Clinic’s urology department did not have the proper credentials to operate the robotic device used during his surgery.
In addition to filing the lawsuit, Antoon complained to the federal Centers for Medicare and Medicaid Services (CMS) and the State Medical Board of Ohio.
However, Antoon also vented his frustrations on social media, as well as sending e-mails to Kaouk, which the doctor felt were threatening and made him concerned about the situation escalating. “What would be next—showing up at my door?” Kaouk asked during the criminal trial against Antoon. “That’s what we feared.”
Jihad Kaouk, MD (above), a urologist with the Cleveland Clinic, giving testimony atCuyahoga County Common Pleas Court during a lawsuit involving patient David Antoon, a retired Air Force Colonel. Kaouk and the Cleveland Clinic prevailed in that lawsuit and the State Medical Board of Ohio closed a five-year investigation into Kaouk without reprimanding him. (Photo copyright: USA Today.)
Antoon posted unfavorable online comments about Kaouk for a decade. The urologist eventually petitioned the court, which granted him a civil stalking protective order against Antoon. It banned Antoon from contacting the doctor. Nevertheless, the day after that order was granted, Antoon posted another bad review about Kaouk on Yelp and urged people to avoid Kaouk when seeking medical care.
Antoon was later arrested on felony charges of menacing by stalking, telecommunications harassment, and violating a protection order. He faced up to one year in prison if indicted. In addition to spending two days in jail, he paid $40,000 for a defense attorney and a $50,000 bond after being arrested. He also agreed to pay $100 as part of a plea deal.
Above is David Antoon (left), Col USAF Ret, and Don Malarcik (right), an attorney with Malarcik, Pierce, Munyer, and Will in Akron, Ohio. Malarcik argued that “the Yelp review doesn’t violate the protection order because Antoon did not make direct contact with Kaouk,” Cleveland.com reported. (Photo copyright: USA Today.)
Other Lawsuits Against Patients Involving Social Media
Joon Song, MD, PhD, a New York City area gynecologist sued patient Michelle Levine over critical reviews she left about his practice on several online sites. Though Levine removed her posts from the sites after being sued, Song wants her to pay $1 million in legal fees and damages. The doctor accused Levine of defamation, libel, and causing emotional distress. Sound familiar?
Two Scottsdale, Ariz., doctors—Albert Carlotti, MD, and Michelle Cabret-Carlotti, MD, DDS,—successfully sued patient Sherry Petta for defamation after she posted negative statements about the doctors online. After filing a complaint with the Arizona Medical Board and clashing with Carlotti over access to her medical records, Petta posted unfavorable reviews about the practice on several online sites and created a website to warn others about Carlotti. The doctors claimed the statements Petta made were untrue and portrayed them in a false light. A jury agreed and awarded the doctors $12 million, which was later vacated on appeal.
Cleveland cosmetic surgeon Bahman Guyuron, MD, sued a former patient after she posted adversarial reviews on several online review sites about her dissatisfaction with a nose job. The patient, who remains unidentified, alleges that Guyuron acted in an untrustworthy and unprofessional manner, that she received no follow-up care, and that Guyuron urges people to post erroneous positive reviews online. She also claims that there was no informed consent to the procedure and that her nose is now twice as large as before.
Guyuron is seeking monetary damages, an injunction against the patient to prevent her from posting negative reviews about him online, and an order to remove all existing statements about him from the Internet.
Clinical Laboratories Vulnerable to Negative Reviews
Healthcare is complicated and positive outcomes can never be guaranteed. When patients do not get satisfaction by complaining to the doctors and facilities, they may seek other ways to be heard. And negative comments made on social media and online review websites can harm the reputations and businesses of physicians and medical facilities.
“It would be great if the regulators of hospitals and doctors were more diligent about responding to harm to patients, but they’re not, so people have turned to other people,” Lisa McGiffert, former head of the Consumer Reports Safe Patient Project, told USA Today. “This is what happens when your system of oversight is failing patients.”
However, Ryan Lorenz, Petta’s attorney warns consumers to be aware of the consequences of posting critical online reviews, especially if they post factually inaccurate information. “Make sure what you are saying is true—it has to be truthful,” he told USA Today.
Similar situations can arise in the clinical laboratory industry as well. There were multiple postings on Yelp in 2014 and 2015 by patients criticizing blood-testing company Theranos regarding discordant test results they’d received from Theranos’ lab, which Dark Daily covered in multiple e-briefings.
Trust is the hardest thing to earn, the easiest thing to lose, and once gone, can be impossible to get back. Clinical laboratories are just as susceptible to negative reviews as hospitals and doctors.
Worse yet, labs can be drawn into lawsuits simply because they service the hospital systems and caregivers involved. Preparing in advance for this possibility should be on every clinical laboratory manager’s do list.