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Lawmakers Urge FDA to Enact Revised Generic Drug Rules in Light of Supreme Court’s Decision Denying Liability

Written by Ankin Law Office

The United Supreme Court ended its term last week, but not without handing down several noteworthy opinions – including several pro-business decisions. One such opinion came in the case of Mutual Pharmaceuticals v. Bartlett, in which the plaintiff had lost 60% of her skin, suffered lung and esophageal damage, and became legally blind after taking a generic painkiller. In Mutual Pharmaceuticals, the Supreme Court overturned the $21 million state court award in her favor, holding that Mutual Pharmaceutical, the generic drug’s maker, wasn’t liable for the painkiller’s content or warning label because federal law requires it to mimic the brand-name drug.

Nonetheless, as a USA Today article points out, the justices were sympathetic to the plaintiff’s position, blaming doctors, Congress, and the U.S. Food and Drug Administration (FDA).

Specifically, the Supreme Court reasoned that because the FDA approved the brand-name drug for sale and because the generic drug is identical to the brand-name drug – even with respect to the warning label – federal law preempted any state law liability of the generic drug maker. Together with last year’s decision in PLIVA v. Mensing, the decision means that patients who take the generic version of a prescription drug may be without legal recourse for any drug-related injuries, even though patients taking the brand-name version of the drug may seek compensation for their injuries.

In the wake of the Supreme Court’s decision, several lawmakers – including Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.), Senate HELP Committee Chairman Tom Harkin (D-Iowa), Senator Al Franken (D-Minn.), and Representatives Chris Van Hollen (D-Md.), Bruce Braley (D-Iowa), Henry Waxman (D-Calif.), and Matthew Cartwright (D-Penn.) – have reiterated their previous call for regulatory action on the part of the FDA to revise drug regulations so that generic manufacturers can improve the warning labels on their products when they receive new information, and can be held accountable if they fail to do so.

Sen. Patrick Leahy said that the decision created “a troubling inconsistency in the law that penalizes the millions of Americans who take generic medications.”

The Chicago unsafe pharmaceutical drug attorneys at Ankin Law Offices, LLC represent clients throughout Illinois and the United States. We have significant experience handling class action lawsuits regarding unsafe pharmaceuticals and are familiar with the complex legal issues that these kinds of lawsuits generally involve. Contact us at (312) 600-0000 for more information on unsafe pharmaceuticals.

Categories: Product Liability