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.
Hellbound and Down 