COVID vaccine makers have a disturbing track record of criminal and civil liability
(Cont’) In a recent example of just such behavior, Johnson & Johnson is likely to pay a multi-billion dollar settlement after the Supreme Court rejected an appeal earlier this month to reverse a 2018 decision by a Missouri Circuit Court which awarded a $4.7 billion payout to 22 women who developed ovarian cancer which they claimed was caused by asbestos present in the company’s talc baby powder.
In June 2020, a Missouri Appeals Court reduced the verdict to $2.12 billion, but maintained the finding of “significant reprehensibility” in J&J’s actions, saying the pharmaceutical company failed to warn consumers of the danger.
This year, Johnson & Johnson’s COVID-19 vaccine rollout was temporarily paused in April after six cases of potentially life-threatening blood clots associated with the vaccine were reported to the Vaccine Adverse Event Reporting System (VAERS).
Civil and criminal litigation for dangerous and illegal practices aren’t new for the vaccine companies.
In 2013, Johnson and Johnson was ordered to pay over $2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega, and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider,” according to the Department of Justice.
Back in 2009, in the largest pharmaceutical settlement in the history of the U.S. Department of Justice at the time, Big Pharma titan Pfizer, which manufactured an mRNA COVID-19 vaccine last year in association with German biotechnology company BioNTech, was forced to pay a $2.3 billion settlement “to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products.”
According to the DOJ, Pfizer misbranded an anti-inflammatory drug which had been pulled from the market, promoting its sale “for several uses and dosages that the FDA specifically declined to approve due to safety concerns.”
Pfizer’s subsidiaries pleaded guilty to a felony for misbranding the drug “with intent to defraud or mislead,” and the company was ordered to pay a criminal fine totaling $1.3 billion, “the largest criminal fine ever imposed in the United States for any matter.” Pfizer paid out another $1 billion “to resolve allegations” related to the illegal promotion of three other drugs.
Similar to the Pfizer and Johnson and Johnson cases, fellow vaccine manufacturer AstraZeneca agreed to pay $520 million in 2010 to resolve allegations that it “illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration.”
U.S. Attorney for the Eastern District of Pennsylvania Michael L. Levy said of the AstraZeneca settlement, “People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors’ judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues.”
Covering a wide range of criminal and civil violations, Big Pharma’s legal troubles also include patent infringement and failure to disclose information regarding government funding and clinical trials.
In October 2020, San Diego-based Allele Biotechnology and Pharmaceuticals Inc. filed a lawsuit against Pfizer and BioNTech, claiming the companies used Allele’s patented “fluorescent protein to help analyze blood drawn from clinical trial patients without Allele’s permission.”
Last month a U.S. District Judge rejected Pfizer and BioNTech’s efforts to dismiss the action, giving the lawsuit the green light to go forward.
Meanwhile, the Gates Foundation-funded pharmaceutical corporation Moderna, which last year underwent an investigation by the Defense Advanced Research Projects Agency (DARPA) for allegedly running afoul of federal law by failing to disclose government support for its patents and applications, “has been criticized for the way it releases its research,” according to the Global Justice Now report.
According to the report, “After the company announced it had seen positive results from its Phase I trial in May 2020,” scientists “raised questions about the company’s claims, suggesting that no significant data had been released to evidence them. Moderna disclosed early results from just 8 of its 45 trial participants.”
The report cited a concern expressed by Anna Durbin, a vaccine researcher at Johns Hopkins University, who said, “It’s a bit of a concern that they haven’t published the results of any of their ongoing trials that they mention in their press release. They have not published any of that.”
Moderna’s secrecy has been called “highly problematic” by former Securities and Exchange Commission (SEC) officials, and “worthy of investigation for potential market manipulation.”
In an article published by Transparency International, Professor Jillian Kohler, director of the WHO Collaborating Centre for Governance, Transparency and Accountability in the Pharmaceutical Sector, wrote, “Now more than ever, pharmaceutical companies need to uphold standards of social responsibility.” Kohler added that “shareholders are not the only ones to whom pharmaceutical companies are accountable; the general public are also key investors.”
By Ashley Sadler
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