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U.S. Supreme Court Shields Generic Drug Manufacturers From Liability for Drug Side Effects
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Yesterday, the U.S. Supreme Court dramatically restricted the rights of consumers injured by prescription drugs. A consumer injured by side effects of a generic drug no longer can sue the drug's manufacturer for failing to warn of known or knowable side effects, even though a person injured by a brand name version of the drug can. Because approximately 75% of all drug prescriptions in the United States are filled with generic drugs, the majority of people injured by drug side effects are now left without a remedy.
The Supreme Court announced this new rule yesterday in Pliva, Inc. v. Mensing in an opinion written by Justice Clarence Thomas. Gladys Mensing's physician prescribed Reglan, but she received the generic form, Metoclopramide, from her pharmacist. Metoclopramide is commonly prescribed for acid reflux and other digestive tract problems. Reglan was first approved in 1980, and its generic form Metoclopramide went on the market five years later.
After Ms. Mensing had taken Metoclopramde for several years, she developed tardive dyskinesia, a severe neurological disorder characterized by repetitive, involuntary and purposeless movements of the face and extremities. These movements most often include grimacing, tongue protrusion, lip smacking, puckering and pursing of the lips, and rapid eye blinking. It is now recognized that tardive dyskinesia is a common side effect when Metoclopramide is taken for more than 3 months, especially among older women.
Ms. Mensing sued Pliva, Inc., the manufacturer of Metoclopramide, for failure to warn that tardive dyskinesia was a possible side effect. Pliva asked for her suit to be dismissed, arguing that federal law preempted her state law claim. Although the Eight Circuit Court of Appeals rejected Pliva's argument, a 5-4 majority of the U.S. Supreme Court yesterday agreed with Pliva, ruling that consumers can no longer bring state law failure-to-warn claims against generic drug manufacturers.
The significance of this decision cannot be understated. The dissenting opinion, written by Justice Sotomayor, explained it this way:
As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.
Pliva, Inc. v. Mensing, No. 90-993, Slip Op. at 2 (Sotomayor, J., dissenting).
For consumers, the message is clear: INSIST that your prescriptions be filled with brand name drugs. If you don't, and accept a generic version then develop serious side effects, you will have no legal remedy against the drug manufacturer, no matter how horrible the side effects.
A copy of the complete Supreme Court decision (both the majority and dissenting opinion), may be obtained HERE.
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Posted By DeCarli Law on
June 24, 2011 02:12 pm |
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