Court confirms Merck lied on vaccine but lets drugmaker off the hook in lawsuit!

KENILWORTH, New Jersey (PNN) - October 11, 2024 - An appeals court this week ruled that even though Merck misrepresented critical data to the Fascist Police States of Amerika (FPSA) Food and Drug Administration (FDA) to gain approval for its updated mumps vaccine - and even though the FDA knew about the false claims - because the agency approved the vaccine anyway, Merck can’t be held responsible for unfairly hurting competitors.

The ruling stems from a class action lawsuit brought by a group of physicians who alleged Merck violated the Sherman Antitrust Act by making false claims about the efficacy of its mumps vaccine on the product’s label in order to stifle competition and maintain a monopoly in the marketplace.

The Sherman Antitrust Act prohibits companies from conspiring to create a monopoly. The FPSA Third Circuit Court of Appeals didn’t dispute the plaintiffs’ allegations that Merck lied to the FDA about the vaccine’s efficacy.

However, citing the Noerr-Pennington doctrine, the court ruled that because the FDA took no action against Merck after discovering the false claims, it was the FDA’s decision - not Merck’s fraud - that injured competitor GSK and the physicians and physician groups who bought the ineffective vaccine at inflated prices.

In a dissenting opinion, Circuit Judge Phipps Shwartz wrote, “This case presents an important question: should a party who makes misrepresentations and material omissions when petitioning the government be granted antitrust immunity? I think not.”

Shwartz argued that Noerr-Pennington, rooted in the First Amendment right to free speech, has an exception that strips immunity from litigants whose activity is disingenuous, and that other courts have also stripped immunity based on misrepresentation or fraud.

However, as a result of Monday’s ruling, the appeals court sent the case back to the lower court with instructions to enter a summary judgment in favor of Merck - meaning the case won’t go to trial.

The undisputed facts in the case: Merck committed fraud. Merck was the sole licensed FPSA producer of the mumps vaccine from 1967-2022.

In the late 1990s, a regulatory labeling review revealed that the mumps vaccine, a component of Merck’s measles, mumps, and rubella vaccine (MMRII), did not maintain the stated potency - and therefore effectiveness - over its shelf life, in violation of FDA regulations.

Merck, with the FDA’s knowledge, boosted the initial potency of the vaccine by overfilling doses with extra quantities of live virus, hoping to create a better buffer to maintain potency throughout its shelf life while the company addressed the potency issues.

The temporary fix didn’t work. But Merck didn’t inform the FDA for fear the agency would compel the drugmaker to reduce the efficacy claims on the label, opening the door for GSK’s rival mumps vaccine.

GSK sold its mumps vaccine in Europe, but could gain approval to access the FPSA market only if it could show the vaccine’s efficacy was non-inferior to Merck’s 95% efficacy claims.

To block that possible competition, Monday’s ruling stated, “Merck sought to extend its apparent monopoly,” by misrepresenting the end of shelf-life vaccine potency and by filing a Supplemental License Application seeking the FDA’s approval to maintain its efficacy claims with a less potent vaccine.

To support the application, Merck attempted to develop more sensitive tests that would allow it to make higher efficacy claims with its less effective drug. Its trial, called Protocol 7, “was a flawed study that did not reliably capture immunogenicity,” the ruling said.

The company used that trial data to persuade the FDA to approve its application. As a result, “Merck continued to make unsupported or misleading claims about the shelf life and seroconversion of its mumps vaccine on the drug label,” the court found.

GSK was locked out of the market, giving Merck an effective monopoly, until 2022. To date, and despite the acknowledged fraud, the FDA has still not required Merck “to change the relevant drug-label claims, issued a recall, ordered revaccinations, or taken any other action against Merck for the purported issues with its mumps vaccine.”

The Centers for Disease Control and Prevention still purchased the drugs for the Vaccine for Children program, and its advisory committee continues to endorse it. Monday’s decision comes only three months after the same federal appeals court dismissed Krahling and Wlochowski’s lawsuit against Merck.

Krahling and Wlochowski blew the whistle on Merck’s fraud in Protocol 007 in the early 2000s, alleging upper management tried to get them to falsify data in the tests the company was conducting to show its mumps vaccine maintained high efficacy.

In 2010, Krahling and Wlochowski sued Merck alleging the company falsified data and fraudulently marketed its MMRII vaccine, which was “mislabeled, misbranded, adulterated and falsely certified as having an efficacy rate that is significantly higher than it actually is.”

They said the company misled the CDC - which purchases the drugs - by “omitting, concealing and misrepresenting” information about the potency of its mumps vaccine, in violation of the False Claims Act.

The case was largely under seal and dragged through the courts for over a decade.

FPSA District Judge Chad Kenney in July 2023 dismissed the case without ruling on whether there was any fraud. The Third Circuit upheld that decision in July 2024.

The Third Circuit stated in its ruling that although Merck may have made false claims to the CDC, those claims didn’t play a role in the agency’s decision to purchase the vaccine, especially given that the FDA was aware of the behavior.

In other words, in both cases, the court acknowledged that Merck committed fraud, but because the FDA was aware of the misrepresentation and took no action, the company is allowed to manipulate the regulatory process without facing any legal penalty.

The (Amerikan) public deserves better. We must demand more transparency and accountability from pharmaceutical companies, regulatory agencies like the FDA, and the courts.