Brand Name Drug Makers Possibly Liable for GenericsNov 10, 2008 | Parker Waichman LLP
A California appeals court ruling that took place this past Friday is likely to generate lawsuits against many in the pharmaceutical industry. The recent ruling put brand name drug makers on notice that they can be held liable not only for injury caused by their own brand name medications, but also for injuries caused by generic drug makers that are selling generic versions of their brand name products.
The First District Court of Appeal in San Francisco, California, reinstated a lawsuit that was originally initiated by Elizabeth Conte. Conte had taken a generic version of Wyeth’s Reglan heartburn medication for nearly four years. She subsequently developed tardive dyskinesia, a condition which causes incurable and involuntary muscle movements. Although Conte only took generic versions of the medication, she accused Wyeth and three generic drugmakers of failing to warn of the risk of long-term use of the medication.
Conte’s doctor may have relied on product warnings distributed to physicians by Wyeth when he decided to prescribe the generic version, the court cited in a three-to-zero decision. Also, a Summary Judgment against the generic drugmakers—Teva Pharmaceuticals, Pliva, and Purepac Pharmaceuticals—was upheld. “As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs,” Justice Peter Siggins wrote, “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 metoclopramide in either the name-brand or generic versions when it is prescribed by their physicians in reliance on Wyeth’s representations.”
The case utilized a "negligent misrepresentation" theory which, if seen to fruition, could enable others to also work around the existing product liability precedant, thus enabling liability without attachment to time or "special relationship" or other concerns. Because there is no effective limitation on the scope of the theory, only "foreseeability," which essentially amounts to no limitation whatsoever, could take place. Some critics argue that this could enable a situation in which brand name manufacturers would be sued for a product for which they do not receive profits and from which generic sales could adversely affect their profits.
Apparently, a preemption argument was implemented that points to the ability for generic manufacturers' to utilize such an opton, thus placing more pressure on the product identification requirement. That requirement has long protected pioneer manufacturers from liability in these types of cases.
Given that misrepresentation is a false statement of fact made by one party to another party, in this case, the court agreed that the negligent misrepresentation is to be charged against the brand name manufacturer as well as the generic drug makers.