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Attention brought to immunity issue involving generic drugs

In most states, a drug manufacturer may be sued if a drug it patents is sold with inadequate warnings and instructions to consumers.  The FDA approves drug warnings and labeling, but the manufacturer remains liable if the language proves inadequate in practice.  Well, actually the manufacturer remains liable in all states except Michigan where "tort reformers" gave manufacturers immunity for all drug claims involving FDA-approved drugs (even if the approval was later withdrawn or originally achieved by fraud or falsified data).

Last year, the U.S. Supreme Court majority granted immunity to generic drug manufacturers for "failing to warn," with the conservative majority holding that since generic manufacturers were merely copying the drug and labeling from patented drugs, they owed no duty to consumers to provide further information.  This immunity grant created an unlikely situation. Consider this example:  Diana Levine, a professional musician who lost a hand when an injection of anti-nausea drug in the ER caused gangrene, collected $5.8 million dollars in damages against Wyeth, the drug manufacturer.  Debbie Schork suffered the identical injury in similar circumstances, however, her claim was dismissed without compensation, because the ER nurse injected her with a generic version of the drug.

Since 80 percent of prescriptions filled in the U.S. are now filled with generics; since many health insurers now require the use of generics and the law allows pharmacies to substitute generics for prescribed medications, there is little or no justification for granting generic manufacturers immunity for inadequate warnings and instructions.  The ultimate goal of a legal system should be to render justice that is uniform, predictable, and consistent.  The situation existing with regard to pharmaceutical manufacturers enjoys none of these characteristics.

Thompson O’Neil, P.C.
309 East Front Street
Traverse City, Michigan 49684
Toll Free: 1-800-678-1307
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