Longtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims. The ruling created a legal injustice for those injured by generic drugs. While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough… Continue Reading
Category Archives: Preemption
Subscribe to Preemption RSS FeedSolicitor General Files Brief in Pliva v. Mensing, Rejects Preemption
Posted in PreemptionA little late, but better than never. Especially since the Solicitor General agrees that failure to warn lawsuits against generic manufacturers are not preempted by the FDCA: The court of appeals correctly rejected petitioners’ contention that respondent’s failure-to-warn claims are categorically preempted by the FDCA, and its decision is consistent with the decision of the… Continue Reading
Another Wyeth Preemption Case Goes to the Supreme Court
Posted in PreemptionBruesewitz v. Wyeth looks like it will be the Wyeth v. Levine of vaccine lawsuits: Erwin Chemerinsky, a liberal scholar, and Kenneth Starr, a conservative, may appear to be the Oscar and Felix of constitutional law, but they’re also friends and, perhaps surprisingly, share essentially the same view in one, increasingly hard-fought area of constitutional… Continue Reading
Black Box Warning for Amputation Finally Ordered
Posted in Preemption, Safety AlertsIt came a little late for Diana Levine, but at least it finally came. TRENTON, N.J. — Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation, the Food and Drug… Continue Reading
The Digitek Recall Shows Us Once Again That the FDA Can’t Protect Us
Posted in FDA Regulation, PreemptionA Brief History of Digitek In 1779, the English doctor William Withering discovered that the Foxglove plant could be used to treat congestive heart failure, and in 1785 he published An Account of the Foxglove and some of its Medical Uses. Foxglove is the common name for the roughly twenty plants in the Digitalis family…. Continue Reading
The Trasylol (aprotinin) Story Illustrates Why FDA Preemption is Bad Public Policy
Posted in Misc. Drugs, PreemptionThe crux of the argument that FDA approval of a drug should preempt state lawsuits over that drug is that it should be experts at the FDA who decide whether a drug is safe and what warnings that drug’s label should carry. Implicit in this argument are the assumptions that the FDA has access to… Continue Reading