Problems Abound for Brand-Name Drug Manufacturers; They May Now Be Liable for Injuries Due to Competitors’ Generic Versions of the Same Drug

Armand Rossetti

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On November 7, 2008 San Francisco’s 1^st District Court of Appeal ruled that original brand name drug makers can now be held liable for injuries that competing generic drug companies cause when they market a generic version of the same drug.

According to an on-line story that appeared today in LAW.COM, Product liability attorneys Mark Herrmann (Jones Day in Chicago) and James Beck (Dechert in Philadelphia) responded quickly by stating that the ruling “stands product liability law on its head.”

The facts are that Elizabeth Conte developed a serious and irreversible neurological condition called tardive dyskenisia, allegedly due to her three and a half year consumption of the generic prescription drug metoclopramide The generic drug is a version of Wyeth’s Reglan, both used to combat gastroesophageal reflux. Conte’s doctor had prescribed both versions of the drug. However it was undisputed that Conte took only Teva Pharmaceutical USA, Inc.’s generic version and not Wyeth’s Reglan.

In her Complaint, Conte claimed that defendants should have known that doctors had a widespread tendency to misprescribe Reglan and the generic version for periods of 12 months or longer, even though the medication was approved for only 12 weeks of use. Conte alleged that the drugs’ labeling substantially understated the risks of serious side effects from extended use.

The lower court case in question is Conte v. Wyeth, Inc., 2006 WL 2692469 (Cal. Super. Sept. 15, 2006). You can access the 1^st Appellate District Court's decision on the lower court’s judgment here.

The trial court entered judgment in favor of Wyeth based on two grounds: (1) Plaintiff Conte could not show that she and her physician had relied upon warnings or product labeling that Wyeth had disseminated; and (2) a name brand pharmaceutical manufacturer owes no duty to individuals who take generic versions of its product.

However the Appellate court reversed the lower court’s judgment in part, holding that: (1) brand-name prescription drug manufacturers owe a duty of care to consumers of its own product and to doctors who foreseeably rely on the brand-name manufacturer’s product information when prescribing either the brand-name or generic version of the medication; and (2) Conte had shown that she had a material factual dispute, concerning whether her doctor had relied on Wyeth’s product information, and that Conte was unable to show that she had relied on generic manufacturer’s information.

It is also interesting to note that the Appellate Court refused to consider FDA-based federal preemption because Conte could not prove that her doctor relied on any of the generic manufacturers’ representations. As a result the court affirmed the lower court’s summary judgment grant in favor of the generic drug manufacturers, and held that Wyeth’s common law duty to use due care in formulating its product warnings remained. Likewise, the duty extends to patients and doctors who foreseeably rely on its product information.

The court opined that to do otherwise would depart from established principles of fault based liability, and would ignore the breadth and effects of Wyeth’s representations in modern commerce.