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Brand-name pharmaceutical manufacturers face the prospect of defending more suits for the alleged harmful effects of drugs they did not actually produce.
Plaintiffs who were allegedly harmed by generic drugs are suing original brand-name manufacturers because of U.S. Supreme Court decisions that have forestalled litigation against the generic pharmaceutical manufacturers.
Suing the brand-name manufacturers “is completely contrary to 50 years of product liability law, but plaintiffs are desperate,” said James M. Beck, a senior life sciences policy analyst with Reed Smith L.L.P. in Philadelphia.
The U.S. Supreme Court’s 2011 ruling in Pliva Inc. v. Messing and its 2013 ruling in Mutual Pharmaceutical Co. v. Bartlett essentially protected generic manufacturers, which constitute about 80% of the market, from state law liability for injuries caused by their products.
The vast majority of the lawsuits against the brand-name manufacturers have been dismissed, say experts. But a California appeals court ruled in 2008’s Conte v. Wyeth that a name-brand pharmaceutical firm owed a duty of care to patients taking generic versions of its drug.
Then in 2016’s ruling in T.H. v. Novartis Pharmaceuticals, a California appeals court, citing the Conte ruling, reinstated a case in which the San Carlos, California-based firm was charged with being liable for injuries allegedly caused by a generic version of its asthma drug, even though the company had sold its interests in the drug almost six years previously.
And in April, a U.S. District Court jury in Chicago awarded $3 million to the widow of an attorney who had committed suicide after taking a generic version of Paxil, a drug manufactured by the brand name manufacturer Brentford, England-based GlaxoSmithKline P.L.C.
Last year, the U.S. Food and Drug Administration proposed a generic drug labeling rule that would have held generic drug companies responsible for updating their labels whenever new safety information was detected, but that apparently has been shelved by the Trump administration, observers say.
That means brand-name manufacturers are “likely to see more attempts to pin liability” on them by patients who took generic versions of their drugs and have no other recourse in the legal system now, said Jim Murdica, a partner with the Barnes & Thornburg L.L.P. law firm in Chicago.
Pharmaceutical manufacturers have long been viewed as a major source of liability exposure, and their risk profiles are getting more complex as they battle a range of liability issues on multiple fronts.