by Brenda Baletti, Ph.D., Childrens Health Defense:
Citing the Noerr-Pennington doctrine, a U.S. appeals court on Monday ruled that because the FDA took no action against Merck after discovering the false labeling 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.
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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 mump 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.
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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.”
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