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Brand Name Drug Makers Could be Liable for Injures Caused by Generic Versions

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A recent ruling in San Francisco’s 1st District Court of Appeals held that brand name drug makers could be liable not only for injuries occurring from their own product, but also for injuries caused by generic drug makers who sell generic versions of their products. Although California stands alone in its decision, it is possible for other districts to follow their lead, which has been done in the past. This could mean that brand-name drug makers will not only need to warn their own consumers about the risks associated with their product, but the duty to warn could spill over into consumers of generic versions of their products as well.

Elizabeth Conte filed suit for fraud and negligent misrepresentation in San Francisco against a name-brand New Jersey pharmaceutical company, Wyeth Inc, and three generic companies, Teva Pharmaceuticals, Pliva, and Purepac Pharmaceuticals. For four years Conte had been taking a generic version of Wyeth’s Reglan medication, or metoclopramide, which treats heartburn and gastroesophageal reflux disease. As a result of taking Reglan for an extended period of time, Conte developed tardive dyskinesia, a neurological disorder which is incurable and causes involuntary, repetitive, purposeless movements. Conte’s attorneys claimed the drug makers failed to warn her about the long-term risks of the medication.

Justice Peter Siggins and the 1st District Court of Appeals agreed with Conte holding, "We believe California law supports Conte’s position that Wyeth owes a duty of care to those people it should reasonably foresee are likely to ingest metoclopramide in either the name-brand or generic versions when it is prescribed the their physicians in reliance on Wyeth’s representations." Although the brand name pharmaceuticals are not liable pursuant to strict products liability because they did not manufacture or sell the drug, they may be liable under negligent misrepresentation. As to the generic manufacturers, the Court upheld summary judgment in favor of the three companies based on the fact Conte’s physician did not rely on their warnings when prescribing Reglan.

Although the jurisdiction of this ruling is limited, there is potential for it to have widespread effects across the drug market. Not only may name-brand manufacturers see an increased number of lawsuits, but they may resort to paying off generic companies to avoid competition and liability.