Expanded Liability for Generic, Brand Manufacturers Ahead? - Pharmaceutical Executive

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Expanded Liability for Generic, Brand Manufacturers Ahead?


Pharmaceutical Executive


Ramifications of the Decision

If the Supreme Court upholds the lower courts' decisions, generics manufacturers will face the same types of failure to warn claims that innovator companies have long confronted. If the Court holds these claims preempted by federal law, generics manufacturers will secure a safe harbor from the massive personal injury litigation that is now commonplace in the industry.

But a ruling in favor of generics manufacturers will also impact brand-name manufacturers, in an ominous way.

It seems logical that a patient injured by a generic drug would not have a claim against the brand-name manufacturer. For many years, most courts agreed with that common-sense approach. But in 2008, a California court came to the opposite conclusion. In Conte v. Wyeth, the plaintiff claimed she developed TD as a result of her use of a generic form of Reglan. She sued both the manufacturers of the generic metoclopramide she took, as well as Wyeth, even though she never took brand-name Reglan. The trial court dismissed the claims against Wyeth.

A California appellate court reversed the judgment in favor of Wyeth, holding: "The common law duty to use due care owed by a name-brand prescription drug manufacturer ... extends not only to consumers of its own product, but also to those whose doctors foreseeably rely on the name-brand manufacturers product information ... ." Because Ms. Conte's doctor testified that he had "probably" read the Reglan PDR entry, judgment in favor of Wyeth was deemed inappropriate.

The Conte case stood alone until last year, when a federal court in Vermont adopted its reasoning in another Reglan case. In Kellogg v. Wyeth (Vermont District Court, October 2010), the court held it reasonably foreseeable that a doctor will rely on information from the brand-name manufacturer, and that there was no reason to "limit Wyeth's duty of care to physicians by the pharmacist's choice of a generic."

Do Conte and Kellogg represent a shift in the law? It's too soon to tell. But if the Supreme Court sides with the generics manufacturers, plaintiffs' lawyers will use the California and Vermont decisions to pursue brand-name manufacturers. All of which underscores the continuing disconnect among Congress, the FDA, and the courts when it comes to prescription drug labeling. Congress says that uniformity in labeling is an important public health goal, and that it wants a strong FDA to regulate every aspect of prescription drug manufacturing, marketing, and the like. (And with the 2007 passage of FDAAA, it gave FDA additional authority to accomplish those goals.) Yet it steadfastly refuses to endorse the notion that FDA oversight should be exclusive, and that its regulations should preempt state law attacks on prescription drug labeling.

The Courts, for their part, refuse to acknowledge the expertise and primary role of FDA in overseeing prescription drug labeling, and cling to the notion that it is important to let lay jurors second guess—and override—FDA's labeling decisions.

And instead of advocating forcefully for its role as the agency best positioned to protect public health by creating and implementing a coherent, uniform, and exclusive system of prescription drug labeling, FDA has too frequently yielded to political pressure, with results like that seen in the government's position in Mensing: simultaneously arguing that the regulations prevented generic manufacturers from changing their labeling, but telling the Supreme Court that they should have "taken steps" to suggest label changes pursuant to some informal, unwritten procedure created by personal injury lawyers and judges.

Instead of certainty and clarity, the three branches of government have conspired to produce confusion and uncertainty when it comes to prescription drug labeling. Whatever the outcome in Mensing, this situation is not likely to change soon. Instead, someone—generics companies, brand-name manufacturers, or both—will face new liabilities.

John F. Brenner is partner in the Health Effects Litigation Practice Group of Pepper Hamilton. He can be reached at


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