Pharmaceutical company Merck is immune from claims that it violated antitrust laws by allegedly misleading the U.S. Food and Drug Administration (FDA) on the efficacy of its mumps vaccine, a federal appeals court has ruled.
The anticompetitive behavior, however, did not violate the law because of immunity under the Noerr-Pennington doctrine, which protects companies that petition the government for redress even if the petitioning causes anti-competitive effects, the judge said.
Merck, which produced the only mumps vaccine available in the United States from 1967 until 2022, responded to FDA concerns about the vaccine’s effectiveness by running new clinical tests, but when the tests did not yield the desired results, Merck submitted falsified data to the regulator, according to plaintiffs in the case, who cited former Merck scientists.
U.S. District Judge Chad Kenney declined to dismiss antitrust allegations in the case last year, prompting an appeal to the Third Circuit.
Two of the three judges on a panel assigned to the case said that even unethical behavior can be protected by Noerr-Pennington immunity, and ruled in favor of Merck.
Even if Merck did make false or misleading claims about its vaccine as alleged, that was the result of Merck’s petitioning of the FDA, according to the majority.
“When the FDA approached Merck with concerns about the end-of-shelf-life potency of its mumps vaccine, Merck had two main options: (1) reveal that its mumps vaccine might be misbranded and then consider remedial actions, like reducing the 24-month shelf life that Merck listed on the drug label; or (2) persuade the FDA that overfilling doses fixed that problem with end-of-shelf-life potency even though Merck knew that was not true and then file [a supplemental license application] requesting the FDA’s permission to maintain the existing drug-label claims about seroconversion with a less potent, and hence longer-lasting, mumps vaccine. Merck chose the second option,” Montgomery-Reeves wrote.
“That gambit worked. And the FDA did not order Merck to change its drug label or take any action against Merck after learning the truth about the purported problems with its vaccine.”
Montgomery-Reeves said that even if Merck publicly admitted to misrepresenting claims on its mumps vaccine, “Appellees cannot show how their harm flowed from Merck’s private conduct when the FDA—government process—approved the label ... because GSK’s vaccine still would have lacked approval and licensure on account of the FDA who—with knowledge of the purported problems—allowed Merck to retain its existing drug-label claims.”
“Thus, there is no genuine dispute of material fact that GSK’s delay was caused by the FDA’s exercise of regulatory discretion in response to Merck’s successful petitioning. And Noerr-Pennington immunity bars Appellees’ § 2 claim against Merck as a matter of law because the antitrust injury that Appellees assert is the result of government action, not private conduct,” she wrote.
Lawyers for the parties involved did not return requests for comment.
U.S. Circuit Judge Patty Shwartz in a dissent said the case revolves around whether a party that makes misrepresentations and omissions when petitioning the government should be granted immunity from antitrust action.
“I think not. As a result, I depart from my colleagues and would affirm the District Court’s order denying Merck summary judgment because a jury should resolve factual disputes over whether Merck made misrepresentations that preclude it from obtaining Noerr-Pennington immunity for its petitioning activity,” Shwartz wrote.
“I would also affirm because, even without considering Merck’s petitioning activity, a reasonable jury could still conclude that Merck engaged in anticompetitive conduct by maintaining misrepresentations on its vaccine’s label to protect its monopoly in the mumps vaccine market.”
