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U.S. Supreme Court Considers Generic Rx Makers' Duty

The Court considers generic drug makers' duty to warn about potentially serious side effects as they become known. AARP argues they have the same responsibility as brand name drug manufacturers.


Generic drugs are crucial in providing lower cost drugs to consumers. They are particularly important to people on low or fixed incomes, and to older consumers because the incidence of health conditions that require pharmaceutical use increases with age.

Congress enacted the Hatch-Waxman Act in 1984 in order to help speed generic drugs to market and thereby open up the market to competition that would benefit consumers and health insurers who purchase pharmaceuticals as part of their policies, including state/federal public health programs such as Medicaid and Medicare.

The law is a carefully crafted measure that balances opening up the marketplace with health and safety regulation. It permits brand name drug manufacturers to have exclusive rights to a drug for specified number of years, after which generic makers may petition the federal Food and Drug Administration (FDA) for approval to produce the drugs in a carefully structured series of processes that regulate production, safety and market entry.

The question has arisen whether that extensive oversight protects pharmaceutical manufacturers from state tort laws governing defective drugs for failure to warn. In 2009, the U.S. Supreme Court ruled in Wyeth v. Levine that brand name pharmaceutical manufacturers are not exempt from state tort laws for faulty drugs or drug use instructions merely because the drugs in question have undergone the lengthy approval required by the FDA. That is, the Court explicitly rejected the manufacturers' claims that FDA approval preempted state law.

The question now turns to whether the same principle allowing state tort laws applies to generic drug manufacturers.

AARP Foundation Litigation attorneys filed AARP's "friend of the court" brief, along with Public Citizen Litigation Group, urging the Court to apply the Wyeth v. Levine reasoning in this case. The brief notes the extensive measures in Hatch-Waxman to hold manufacturers liable for defective drugs or drug instructions, the fact that many side effects are not known until after the drugs have been on the market for many years (in other words, until the drugs are in circulation), and the Court's own precedent holding brand name manufacturers liable under state law. The brief points out that holding generic makers to a lower standard would "effectively punish consumers for choosing generic drugs" and would send the message that generics are less trustworthy than name brand drugs — directly counter to the intent of Congress in enacting Hatch-Waxman. Although it has been argued that post marketing surveillance of generic drugs would be so expensive as to negate the cost savings gained by their availability, the brief argues that generic makers themselves have accepted responsibility for monitoring drug after they have been introduced into the marketplace and minimized the costs of post marketing surveillance.

Status of the Case

The consolidated cases, now known as Pliva v. Mensing, are before the U.S. Supreme Court.

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