The U.S. Supreme Court has ruled that state court claims against generic drug manufacturers for inadequate warnings are in conflict with federal law. As a result, such state court actions are pre-empted and hundreds of such pending case may now need to be dismissed. Such a ruling means there is really no responsibility that a generic drug manufacturer has to warn users of dangers not already listed on the FDA approved label.
Question remain however. What happens to generics made by a brand-name manufacturer? Sotomayor says this doesn’t apply to them. When a name-brand leaves the market, the FDA selects a generic to be the new reference listed drug. If that happens, is the generic liable from that point forward? We have never had to deal with that. The generics have always argued, "We’re just dumb generics, we don’t have labs, we don’t do studies, so we can’t be held to the standards of knowledge of a ‘real’ drug maker." But nothing in the majority opinion addresses this argument. I assume the manufacturer’s duty to be an expert in its field continues. What happens to Conte v. Wyeth (Cal. Ct. App.) and Kellogg (D. Vt.), the two outlier decisions that say brand-names can be sued on a fraud theory when people are injured by generic products? Does this type of jurisprudence expand now? There will be strong pressure by the name-brands on Congress to take Justice Thomas’ invitation to change the law. Otherwise, the name-brands will continue to be sued and held to account by these outlier states. Also, there will be pressure from Medicaid plans, health insurers, and others. Nearly all the state AGs joined the plaintiffs in Mensing/Demahy.
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