The Law and the Merck Mumps Case, By Chris Knight (Florida)

The U.S. 3rd Circuit Court of Appeals, has ruled for Big Pharma company Merck over a case made by a group of physicians and physicians' groups, who alleged Merck violated the Sherman Antitrust Act in making false claims about the efficacy of its mumps vaccine on the product's label in order to reduce competition and maintain its monopoly in the marketplace. The court held that the representations made to the U.S. Food and Drug Administration (FDA) to gain approval for its new mumps vaccine were false and that the FDA knew that, but because the FDA did then approve the vax, there was no anti-competition issue.

Here is the formal black letter of the law at work. As I understand it, it is correct that the anti-competition case failed. But why did the doctors and doctor groups pursue that line in the first placed? Surely the more important issue is that the data given to the FDA was false and the FDA knew it, but still approved the vax? Here are two cases of fraud and administrative negligence that should have been pursued, and still could be.

The problem is getting too tangled up in the technicalities of the law. But as well, it is one more reason to be sceptical about the claims of Big Pharma, and health authorities, who do not do their job, unless that job is to serve Big Pharma.

https://childrenshealthdefense.org/defender/merck-mumps-vaccine-false-labeling-antitrust-lawsuit/

"An appeals court this week ruled that even though Merck misrepresented critical data to the U.S. 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 and physicians' groups 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 U.S. 3rd 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 physicians groups who bought the ineffective vaccine at inflated prices.

The Noerr-Pennington doctrine grants limited exemption from antitrust liability. The doctrine states that if a party petitions the government for redress and is granted it, the party isn't violating the Sherman Antitrust Act — even if the outcome protects the party's monopoly.

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.

Aaron Siri, managing partner of New York law firm Siri & Glimstad, who was not involved in the case called the verdict "UNREAL" in a comment on X.

"Two peas in a pod: a lying, fraudulent pharma company, blessed by a head-in-the-sand 'regulator,' FDA. The latter frees the former from antitrust claims for the damage done to competitors and to the marketplace," he wrote.

James Lyons-Weiler, Ph.D., director of the Institute for Pure and Applied Knowledge, said the decision "revealed a profoundly unsettling reality."

"Merck can legally misrepresent critical data in its vaccine trials and face no antitrust liability, all under the protection of the Noerr-Pennington doctrine," he wrote in a Substack commentary. "This decision is a profound failure to protect public health and a failure of our judiciary to uphold corporate accountability."

The undisputed facts in the case: Merck committed fraud

Merck was the sole licensed U.S. 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 U.S. 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.

In another lawsuit related to the same fraudulent labeling issue, whistleblowers Stephen Krahling and Joan Wlochowski, who worked as virologists on Merck's Protocol 7 study, alleged they witnessed improper testing, data falsification and violation of duties of government disclosure.

In that lawsuit, it was revealed that the FDA inspected Merck's lab and confirmed evidence of data falsification. It was also revealed that the overfilled doses had never been tested for safety or efficacy.

Yet, 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 Vaccines for Children program, and its advisory committee continues to endorse it.

'American public deserves better'

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.

U.S. District Judge Chad Kenney in July 2023 dismissed the case without ruling on whether there was any fraud. The 3rd Circuit upheld that decision in July 2024.

The 3rd 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 American public deserves better," Lyons-Weiler wrote. "We must demand more transparency and accountability from pharmaceutical companies, regulatory agencies like the FDA, and the courts."