Makers of Generic Drugs Don’t Have to Warn of New Dangers, Supreme Court Rules

Washington – The Supreme Court gave the pharmaceutical industry a pair of victories Thursday, shielding the makers of generic drugs from most lawsuits by injured patients and declaring that drug makers had a free-speech right to buy private prescription records to boost their sales pitches to doctors.

In both decisions, the court's conservative bloc formed the majority, and most of its liberals dissented.

About 75% of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs. Federal law requires the original makers of these brand-name drugs to include an approved and up-to-date warning label that tells doctors and patients of possible side effects or complications.

But in a 5-4 decision, the high court said this duty to warn patients of newly revealed dangers does not extend to the makers of generic drugs. Justice Clarence Thomas said that because the federal Food and Drug Administration must approve changes in the warning labels, the generic makers may not be sued under state liability laws for failing to warn patients of new dangers.

“We find impossibility here,” Thomas said, because the federal regulatory law and the state liability law are in conflict. The dissenters said the generic drug makers should notify the FDA and its patients as soon as it receives reports of serious new problems.

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The decision in Pliva vs. Mensing throws out lawsuits from two women who developed tardive dyskinesia, a severe neurological disorder, after taking a generic metoclopramide for acid reflux disorder. The drug had been on the market for many years before doctors realized that taking it for more than 12 weeks could trigger the neurological problem.

In the second decision, the court by a 6-3 vote struck down a law in Vermont that barred pharmacies, drug makers and others from buying or selling prescription records from patients for “marketing” purposes. Vermont's physicians had sought passage of the law, arguing their prescriptions were intended for private use of patients and should not become a marketing tool.

Drug makers buy this data to gear their sales pitches to physicians.

But Justice Anthony M. Kennedy said “information is speech” and that, under the 1st Amendment, the government cannot restrict speech because it does not approve of the message. “If pharmaceutical marketing affects treatment decisions,” he said, “it does so because doctors find it persuasive.”

Justices Stephen G. Breyer, Ruth Bader Ginsburg and Elena Kagan dissented. Breyer called Vermont's measure “a lawful government effort to regulate a commercial enterprise.” The case was Sorrell vs. IMS Health.

Sen. Patrick Leahy (D-Vt.) , chairman of the Senate Judiciary Committee, criticized the decision for having “overturned a sensible Vermont law that sought to protect the privacy of the doctor-patient relationship.”