By David G. Savage, Los Angeles Times
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 withÂ 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.
JusticeÂ 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 â€” 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 JusticeÂ 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. JusticesÂ Ruth Bader Ginsburg,Â Stephen G. Breyer andÂ Elena Kagan agreed.
To read more, visit:Â http://www.latimes.com/health/la-na-court-drugs-20110624,0,5783097.story
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