Drug labels: Generics don't need warning updates
Drug labels and prescription records decisions by the Supreme Court Thursday favor the pharmaceutical industry. The court ruled that drug labels for generics don't need the same updated warnings that the brand-name makers do.
WASHINGTON — The Supreme Court gave the pharmaceutical industry a pair of victories, 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 Thursday, the court's conservative bloc formed the majority, and most of its liberals dissented.
About 75 percent of the prescriptions written in this country are for lower-cost generic versions of brand-namedrugs. Federal law requires the original makers of these brand-name drugs to post an approved warning label and to update these warnings on drug labels when reports of new problems arise.
But in a 5-4 decision, the high court said this same legal duty to warn patients of newly revealed dangers does not extend to the makers of copy-cat generic drugs.
Justice Clarence Thomas reasoned that the warning labels are the responsibility of the brand name maker and the U.S. Food and Drug Administration. He said that because generics are just copycats, their makers cannot be sued for inadequate warnings.
Thomas said that the federal regulatory law trumps the state liability law in this instance and therefore shields the generic makers. "We acknowledge the unfortunate hand" that was dealt to the patients whose suits were dismissed Thursday.
Gladys Mensing and Julie Demahy developed tardive dyskinesia, a severe neurological disorder, after taking metoclopramide, a generic drug for digestive problems, including acid reflux. They sued, alleging the drugmaker failed to warn them of the danger of taking this drug for more than 12 weeks. In tossing out their claims in Pliva v. Mensing, Thomas put the blame on "the special, and different regulation of generic drugs."
They are supposed to be copy-cat versions of the original, he said, so the makers cannot be sued for failing to give patients new and different warnings.
But the dissenters, led by Justice Sonia Sotomayor, said the blame lies with the court's majority. She said the generic drug maker should have alerted the FDA of the danger and then updated their warning label. "This outcome makes little sense," she said. Justices Ruth Bader Ginsburg, Stephen G. Breyer and Elena Kagan agreed with her.
A consumer-rights lawyer said the ruling strips many Americans of an important legal right. "Three out of four patients just lost the right to sue" if they use a generic drug and suffer complications for which they were not warned, said Louis Bograd, counsel for the Center for Constitutional Litigation. These patients "appear to be left without any legal remedy."
In the second decision, the court by a 6-3 vote struck down a Vermont law that barred pharmacies, drugmakers 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. Several data-mining firms have made a billion-dollar business out of buying and selling the prescription data to drug makers and researchers.
Writing for the court, Justice Anthony M. Kennedy said "information is speech" and that, under the First Amendment, the government usually 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."
Dissenting again were Breyer, Ginsburg and Kagan. Breyer called Vermont's measure "a lawful government effort to regulate a commercial enterprise." The case was Sorrell v. 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."