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CA Supreme Court: Wyeth Liable Even Though Patient Never Took the Drug

By Jim Edwards | Feb 12, 2009

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 …)

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

BNET User Analysis

Web Buzz:
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    BNET Pharma - 305 days 18 hours 34 minutes ago

    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...

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    The Supreme Court struck a blow to FDA pre-emption of state laws with a 6-3 decision in Wyeth v. Levine finding the company liable for a failure-to-warn claim under Vermont state law.

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    rogert73

    02/16/09 | Report as spam

    RE: CA Supreme Court: Wyeth Liable Even Though Patient Never Took the Drug

    Completely ridiculous!!!

    If a generic firm manufactures and sellls the drug, they shoulkd own complete liability for any damage caused by the drug.

    This is like me losing points on an exam because someone copied a wrong answer from my paper.

    Maybe i am looking at the courts and Pharma from the wrong point of view. This case would make sense if the US Gov't really wanted to prevent the development of all new drugs in the future.

    Wake up America, public companies pay for R&D out of profits. If our gov't eliminates Pharma's profits, they will eliminate the flow of new drugs.

    If you have ever used perscription meds, beware of the Gov't campaign to make Pharma into the evil empire. It will eventually lead to the end of new drugs. Hopefully you and your children will not need any drug that hasn't already gotten to market, because the future supply may be cut off just before cancer is cured!!!

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