Merck & Co. has been granted immunity from an antitrust lawsuit accusing the pharmaceutical giant of misleading regulators about the effectiveness of its mumps vaccine in an attempt to stifle competition, a U.S. federal appeals court ruled Monday. handed down the verdict. The ruling was handed down by a 2-1 panel of the 3rd U.S. Circuit Court of Appeals, which found Merck was protected under a legal doctrine known as Noah Pennington immunity, Reuters reported. This principle shields companies from antitrust liability when they petition the government, even if their actions could restrict competition.
The lawsuit was originally filed in 2012 by a group of doctors and other health care professionals, alleging that Merck & Co. engaged in deceptive practices to maintain its dominance in the mumps vaccine market, forcing health care workers to avoid vaccines. He claims that he was forced to overpay. According to Reuters, Merck and the plaintiffs’ legal teams did not immediately respond to requests for comment after the court’s ruling.
New Jersey-based Merck was the exclusive provider of the mumps vaccine in the United States from 1967 to 2022, offering it as part of the widely used MMR-II vaccine that also protects against measles and rubella. ProQuad, another combination vaccine that includes protection against chickenpox, was also part of Merck’s portfolio.
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The controversy stems from concerns raised by the U.S. Food and Drug Administration (FDA) about the effectiveness of the mumps vaccine in the late 1990s. According to the complaint, the FDA noted that the vaccine’s efficacy diminishes as it approaches the end of its 24-month shelf life, prompting Merck to take corrective action. The plaintiffs allege that Merck responded by increasing the vaccine’s initial efficacy, but used flawed clinical trials to demonstrate continued effectiveness. This allowed the company to allegedly hide the problem from the FDA, which then approved an updated vaccine without revising its efficacy claims.
Plaintiffs further argued that the alleged deception had far-reaching effects on market competition. Specifically, it claimed that British pharmaceutical company GlaxoSmithKline (GSK) chose not to develop its own mumps vaccine because it believed it could not match the effectiveness of Merck’s product. GSK, which is not a party to the lawsuit, reconsidered its efforts to develop the vaccine only after learning of alleged flaws in Merck’s clinical trials, Reuters reported.
Noah Pennington’s legal doctrine of immunity played a vital role in the court’s decision. This principle, established in U.S. antitrust law, holds companies accountable for anticompetitive conduct when lobbying or petitioning the government for policy decisions, even if the result is to stifle competition. It is stipulated that no liability can be incurred.
With this ruling, Merck successfully avoided antitrust claims in this case.
Source: Reuters
