Wyeth Held Liable in Case Where Patient Never Took the Company's Drug
A California appellate court has upheld a ruling holding Wyeth liable for injuries suffered by a patient who took the generic version of Reglan, but never actually took Wyeth's branded drug.
Critics of the ruling -- including the Drug and Device Law blog -- have said that the ruling stands tort law on its head, as normally plaintiffs have to prove that they actually used the product that caused the injury.
The latest ruling leaves in place, in California, a new principle for drug manufacturers, which is that as long as it is forseeable that the actions of one manufacturer might cause injury to a third party, even if the third party did not take the manufacturer's drug, then the original manufacturer can still be liable.
In the case, Elizabeth Conte was treated for gastroesophageal reflux disease. Her doctor prescribed her Wyeth's Reglan for the disease, but every time she filled her prescription it was switched for a generic, made by Teva, Purepac and Pliva. She developed tardive dyskinesia, a debilitating and incurable neurological disorder, after taking generic metoclopramide for almost four years between August 2000 and April 2004.
The ruling is highly likely to be appealed. But for those of you who want to understand why, exactly, Wyeth should be held liable for injuries caused by a drug it never sold, here's a condensation of the court's ruling:
[Conte wants a trial on whether] Wyeth failed to use due care when disseminating its product information.Teva and others relied on -- and in fact copied -- Wyeth's product information when they got licenses for their generic versions. The court said that liability might arise if a defendant drug maker:
intends his statement to induce or should realize that it is likely to induce action by the other, or a third person, which involves an unreasonable risk of physical harm to the other, and knows that the statement is false, or that he has not the knowledge which he professes.
... It is therefore highly likely that a prescription for Reglan written in reliance on Wyeth's product information will be filled with generic metoclopramide.
And, because by law the generic and name-brand versions of drugs are biologically equivalent ... it is also eminently foreseeable that a physician might prescribe generic metoclopramide in reliance on Wyeth's representations about Reglan.
In this context, we have no difficulty concluding that Wyeth should reasonably perceive that there could be injurious reliance on its product information by a patient taking generic metoclopramide.See you in court!
Image by Flickr user bloomsberries, CC.