Is pharma liable for knockoff meds, too?

While we were watching Wyeth v. Levine [1] have its day in the U.S. Supreme Court, another Wyeth case hit the California appeals courts--and what happened there stunned drug-law types. That's because three justices ruled Wyeth could be held liable for harm caused not by one of its own drugs, but by a generic version of a medication that went off patent more than 25 years ago.

In the case of Conte v. Wyeth, a woman alleged that she developed a neurological disorder because of her long-term use of metoclopramide, the copycat form of Wyeth's acid-reflux med Reglan. Conte argued that Wyeth should have warned doctors that Reglan and its generic forms shouldn't be used for more than 12 weeks at a time. The trial judge ruled for Wyeth.

But in a unanimous ruling, the appeals court reversed that decision. "As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs," Justice Peter Siggins wrote in the court's opinion on the case, "so too runs the duty of care."

Will that verdict stand when it inevitably reaches the California Supreme Court? Liability lawyers want to say "No." Two attorneys who blog about drug and device law wrote that the ruling "stands product liability law on its head." And one of them, Mark Herrmann, a Jones Day partner, told Law.com, "Virtually all the precedents went the other way." And over at In the Pipeline, Derek Lowe pronounces himself incredulous. "How Wyeth can be held liable for the use of a product that it did not manufacture, did not label and did not sell is a mystery to me." Stay tuned.

- read the article [2] at Law.com
- check out the In the Pipeline post [3]
- see the story [4] at AmLawDaily