Pharmaceutical companies have been handed a double victory by the U.S. Supreme Court. In separate decisions, the high court shielded generic drug makers from most patient-injury lawsuits and also ruled that drug companies have a free speech right to buy private prescription records to help promote their products to doctors.
As the Los Angeles Times reports, both high court decisions were split along ideological lines, with its conservatives in the majority and most of its liberals in dissent.
The first case, Pliva Inc. vs. Mensing, stemmed from a suit brought by two patients who suffered neurological disorders linked to taking an acid reflux drug and who argued the manufacturer should have indicated the potential hazard.
Federal law requires the makers of brand-name drugs to label their products with warnings approved by the Food and Drug Administration and to update the labels as new problems are reported. But in a 5-4 decision, the high court said the updating requirement did not apply to manufacturers of generic versions of the same drugs.
Writing for the majority, Justice Clarence Thomas reasoned that, because warning labels are the responsibility of the brand-name makers and the FDA and given that generics are merely copies, their makers cannot not be sued for inadequate warnings not on the brand-name drugs.
Justice Sonia Sotomayor led the dissenters, saying the generic drug maker should have alerted the FDA to the danger and then updated its warning label.
Louis Bograd, a consumer rights lawyer, said the ruling means “three out of four patients just lost the right to sue” if they suffer complications from a generic drug about which they were never warned.
In the second decision, Sorrell vs. IMS Health Inc., the court by a 6-3 vote struck down a Vermont law that prohibited pharmacies, drug makers and others from buying or selling prescription records for marketing purposes. Vermont’s doctors supported passage of the law on privacy grounds, arguing that their prescriptions were for patients and should not become a marketing tool.
Drug makers buy prescription information to help them tailor their sales pitches to doctors. Several data-mining firms have made a billion-dollar enterprise out of selling the information to drug makers and researchers.
Writing for the court, Justice Anthony M. Kennedy said that “information is speech,” which under the 1st Amendment, the government usually cannot restrict.
In dissent, Justice Stephen G. Breyer called Vermont’s measure “a lawful governmental effort to regulate a commercial enterprise.”
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.”
Maine and New Hampshire have adopted similar laws, in part to deter drug companies from pressuring doctors into prescribing newer, pricier brand-name drugs.
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