A Pennsylvania federal judge agreed to hear a majority of the claims against Merck & Co. in a qui tam lawsuit and related antitrust putative class action case. U.S. District Judge C. Darnell Jones II of the Eastern District of Pennsylvania issued an opinion Friday in the two related lawsuits: United States v. Merck & Co. and Chatom Primary Care v. Merck & Co.
Two of Merck’s former virologists, Stephen Krahling and Joan Wlochowski, acting as relators, brought up claims against under the False Claims Act against Merck, the manufacturer of the MMR vaccine, according to the Legal Intelligencer. The two alleged that Merck became the only FDA approved company to manufacture a version of the MMR vaccine by falsifying efficacy results. Merck claimed the MMR vaccine had a 95 percent efficacy rate.
The putative class action lawsuit alleges “manipulation and misrepresentation” of the MMR vaccine’s efficacy and claimed the fraud allowed for Merck to maintain a monopoly on the market. Merck asked the judge to dismiss both actions, but he found that relators can plead a fraud-on-the-FDA theory through a False Claims Act lawsuit. The motions to dismiss were mostly denied.
The judge dismissed some of the state law claims in the class action suit.
The judge sustained the Sherman Act claim. The judge said that it was a “slightly novel theory of liability,” but that there was a basis for an antitrust claim there and he would hear the arguments against the vaccine manufacturer.
“Plaintiffs have argued sufficient facts to sustain a claim for proximate causation, detailing the significant barriers that other companies would face to enter the mumps vaccine market,” Judge Jones said.
Merck argued that the “95 percent efficacy” claim is a labeling issue that is between Merck and the FDA. Merck suggested that the label’s claim can not be disputed through a False Claims Act suit. The judge disagreed with Merck and agreed to hear the claims against Merck in the qui tam suit.
“Relators allege that [Merck] consistently and deliberately withheld pertinent information as to the safety and efficacy of a medication from the government,” Jones said. “It is this alleged omission that is the grounds for FCA liability.”
The judge said that the relators showed that there was enough information about the MMR vaccine that was not reported to the government, and that if the information had been made available, the government might not have purchased the vaccines from Merck, according to Law360.
Between the lawsuits and the CDC Whistleblower, it’s been a rough summer for Merck and the MMR vaccine.
[Photo by Danny Ayers]