Posted On: April 25, 2012 by Patrick A. Malone

Legislation Aims to Bring Fairness to Patients Hurt by Generic Drugs

Last year, a U.S. Supreme Court ruling prohibited injured patients from suing generic drug companies. Because such companies lacked control over the content of their labels, the court said, if they’re unable to print warnings about drug side effects, patients shouldn’t be able to sue them.

A previous Supreme Court decision allowed patients who took brand-name drugs to sue their manufacturers. Since the decision last year, cases have been thrown out in which patients claimed harm from taking generic drugs. But in many of those cases, the plaintiffs suffered the same injuries as people who took the brand-name versions.

Last week, companion bills were introduced in both houses of Congress to address the inconsistency.

“If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings,” said Sen. Patrick Leahy, D-VT, in a statement. “If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries,” he said.

The legislation, as reported by The New York Times, would permit generic drug companies to update warning information about the drugs they manufacture. That would enable patients to sue them if they failed to warn about the risks associated with their drugs.

If it seems like a no-brainer that what’s good for the goose is good for the gander, the outlook for passage isn’t exactly rosy: The Republican-controlled House is likely to vote thumbs-down.

Consumer groups have requested that the FDA take similar action, but the agency has demurred.

As The Times reported, generic drug companies have opposed the label content measure on the grounds that it could create chaos. What if several different drug companies publish conflicting warning information about the same drugs? Now, only brand-name drug companies may update the labels, including everything about a drug’s uses, dosages and risks. Then, generic manufacturers must follow suit.

You’d expect Big Pharma to wiggle away from accountability. Let’s hope Congress does the right thing.

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