Supreme Court sides with pharmaceutical industry in two decisions
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 have 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% of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs. Federal law requires the makers of brand-name drugs to label their products with FDA-approved warning information and to update the warnings 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 did not extend to the makers of copy-cat generic drugs.
Justice Clarence Thomas reasoned that the warning labels were the responsibility of the brand-name makers and the Food and Drug Administration. He said that because generics were just copies, their makers could not be sued for inadequate warnings if those warnings didn’t exist on the original.
Thomas said the federal regulatory law trumped the state liability law in this instance and therefore shielded the generic makers. “We acknowledge the unfortunate hand” that was dealt to the patients whose suits were dismissed Thursday, he wrote in his majority opinion.
The patients, Gladys Mensing and Julie Demahy, developed tardive dyskinesia, a severe neurological disorder, after taking metoclopramide, a generic form of the drug Reglan for digestive problems, including acid reflux. They sued, alleging that the drug maker failed to warn them of the danger of taking this drug for more than 12 weeks. Studies had suggested a potentially increased risk of the condition — and Reglan was eventually required to carry a “black box” warning about it. That wasn’t the case at the time.
In tossing out their claims in Pliva Inc. vs. 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 as they develop.
But the dissenters, led by Justice Sonia Sotomayor, said the generic drug maker should have alerted the FDA to the danger and then updated its warning label. “This outcome makes little sense,” she wrote. Justices Ruth Bader Ginsburg, Stephen G. Breyer and Elena Kagan agreed.
A consumer rights lawyer said the ruling stripped 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, 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 that 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 that “information is speech,” and that under the 1st 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.
Maine and New Hampshire have adopted similar laws, in part to deter drug makers from pressing doctors to prescribe newer and more expensive brand-name drugs.
Dissenting were Breyer, Ginsburg and Kagan. Breyer called Vermont’s measure “a lawful governmental effort to regulate a commercial enterprise.” The case was Sorrell vs. IMS Health Inc.
Sen. Patrick J. 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.”