As the nation waits to hear the U.S. Supreme Court’s decision in Wyeth v. Levine and whether pharmaceutical companies can be liable for patient injuries, some of that focus has shifted to a California case that may open up a whole new area of product liability litigation – that pharmaceutical companies may be liable for injuries from generic versions of their drugs manufactured by other companies.

What this products liability case is all about

The California case concerns a woman named Elizabeth Conte. According to news reports, Conte had been taking the generic version of Wyeth’s heartburn medication, Reglan, over a four year period. However, she developed a condition known as tardive dyskinesia which causes involuntary and incurable muscle movements. She sued the makers of the generic drug, Teva Pharmaceuticals, Pliva and Purepac Pharmaceuticals AND Wyeth for failing to warn consumers about the drug’s dangers.

The First District Court of Appeals in San Francisco recently reinstated the case – leaving open the possibility that pharmaceutical companies may be liable for injuries relating to drugs they first put on the market and which were later copied by companies who make generic drugs. According to the court:

As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs, so too runs the duty of care and Wyeth has not persuaded us that consideration of other factors requires a different conclusion …. 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 [a drug] in either the name-brand or generic versions when it is prescribed by their physicians in reliance on Wyeth’s representations.

Negligent misrepresentation

The case focused on the legal theory of negligent misrepresentation which occurs when a defendant carelessly makes a representation while having no reasonable basis to believe it to be true. The court reasoned that it should have been forseeable to Wyeth that drug companies and physicians prescribing generic versions of its product would rely upon Wyeth’s statements concerning Reglan and apply them to generic versions.

While it’s too early to tell how this case will be decided, pharmaceutical companies will be watching this case and the U.S. Supreme Court’s case of Wyeth vs. Levine – in which pharmaceutical companies are claiming that because the FDA has the final approval on whether or not certain drugs can be sold, that they should not be held liable when complications later arise – very closely.