CA Supreme Court: Wyeth Liable Even Though Patient Never Took the Drug
The California Supreme Court has declined to hear a case in which Wyeth (and now Pfizer!) was held liable for injuries suffered by a patient who took a generic version of Reglan, even though the patient never actually took Wyeth's drug, only generics made by competitors.
According to FDA Law Blog, the decision leaves in place a previous ruling by a California appeals court that said drug companies can be sued for injuries if it was:
... eminently foreseeable that a physician might prescribe generic metoclopramide in reliance on Wyeth's representations about Reglan.The back story: 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.
In the case, it appears that the generic makers simply copied Wyeth's patient information for Reglan when they manufactured their versions. The case -- which now goes to trial -- therefore hinges on whether Wyeth gave out bad information on its drug.
Previously, plaintiffs had to prove they used a company's product in order to make claims of injury.
Note: Filing an amicus brief in this case was the Washington Legal Foundation. They'll be back on this issue. Expect, in the years to come, briefs filed with the US Supreme Court. There's no way Big Pharma will stand for this massive expansion of tort law (even though it doesn't seem too unreasonable to require companies to provide good info if they know docs are going to rely on it ...)
- See BNET's previous coverage of Conte v. Wyeth:
- Wyeth Held Liable in Case Where Patient Never Took the Company's Drug