Wyeth faces suit for injury from generic drug

SAN FRANCISCO--A name-brand prescription drug manufacturer can be held liable for injuries caused by the generic

version of the drug made by another manufacturer, a California appellate court has ruled.

The ruling, which allows a

lawsuit against Madison, N.J.-based Wyeth Inc. to go to trial, is the opposite of numerous other decisions on the issue and

could create liability concerns for brand drug manufacturers if upheld, attorneys say.

The 1st District Court of Appeal in

San Francisco said its Nov. 7 decision in Elizabeth Ann Conte v. Wyeth Inc. was based on Ms. Conte's physician's alleged

reliance on Wyeth's representations about Reglan, the brand name of metoclopramide, which is used to treat gastroesophageal

reflux disease.

Ms. Conte developed tardive dyskinesia, a debilitating and incurable neurological disorder that causes

involuntary muscle movements, after taking a generic version of the drug for nearly four years, although it is approved for

only 12 weeks of use. Ms. Conte, who never took Reglan, claimed Reglan's product warnings substantially understated the risks

of serious side effects from extended use.

She sued Wyeth for fraud, fraud by concealment and negligent misrepresentation.

She also sued three generic manufacturers of the drug, on the grounds of, among other things, negligence and strict product

liability.

A lower court dismissed the charges against all the drug manufacturers. On Wyeth, the court concluded that

neither Ms. Conte nor her doctor relied on drug information provided by Wyeth, and that Wyeth owed no "duty of

care" to users of generic versions of its drug.

It also dismissed the case against the generic drug manufacturers,

deciding that Ms. Conte's state tort claims were pre-empted by federal law.

The appellate court, however, unanimously

reversed the judgment in favor of Wyeth while upholding the dismissal of claims against the generic drug

manufacturers.

Referring to Wyeth, the three-judge panel's decision said "a name-brand manufacturer that disseminates

information about its product owes a duty of care to ensure the information's accuracy to any doctor who prescribes the drug

in reasonable reliance on that information, even if the patient ends up taking the name-brand product's generic

equivalent."

The court said it affirmed the dismissal against the generic drug manufacturers because, while there is a

dispute as to whether the woman's doctor relied on Wyeth's product information, Ms. Conte was unable to show her doctor

relied on any information provided by the generic drugmakers.

The appellate court did not deal with the federal

pre-emption issue in its opinion, stating it was unnecessary in light of its disposition of the appeal. It also acknowledged

its ruling conflicts with previous court rulings outside California on the subject.

A case now before the U.S. Supreme

Court, Wyeth Inc. vs. Diana Levine, focuses on whether the Food and Drug Administration's approval of a warning label on an

anti-nausea drug pre-empts a state product liability lawsuit (BI, June 30).

A Wyeth spokesman said the California appellate

court decision will be appealed.

"The company disagrees with the reasoning of the court, which rejects a long line of

cases in which courts have uniformly found that a drug manufacturer of a brand drug cannot be liable for injuries caused by a

generic version of the brand drug sold by another manufacturer," the Wyeth spokesman said in a statement.

The

spokesman said while he is unsure as to whether this is the first case to rule this way, 14 other jurisdictions have held

that a brand name-drug manufacturer cannot be held liable in cases involving generic drugmakers.

The decision stands

product liability law "on its head," said James M. Beck, a product liability defense attorney with Dechert L.L.P.

in Philadelphia.

"It's an extreme extension of the law. It eliminates altogether the connection between making a

product and being liable for that product," he said.

It creates a situation where the actual drugmaker is not liable

but the firm that made the pioneer drug "is liable for somebody else's product, and that's just absurd," Mr. Beck

said.

Jonathan Allan Klein, a defense attorney with Kelly, Hockel & Klein, P.C. in San Francisco, said the unprecedented

decision "has tremendous significance."

It "opens up a Pandora's box of litigation," said Mr.

Klein.

Brand name-drug manufacturers, it would seem, "now need to be worried about being sued because someone who took

a different drug, one it did not manufacture," might allege their warnings were inadequate. This will make drug

companies reluctant to invest more into research, Mr. Klein said.

To hold the manufacturer of a pioneer drug liable

"for a drug it didn't expressly manufacture is problematic," said Heather L. Hodges, a defense attorney with

Crowell & Moring L .L.P. in Washington.

She said it is difficult to tell how significant the decision is because it is a

ruling by an intermediate state court. "It's definitely something that caught a lot of observers off-guard," and a

case that pharmaceutical companies will watch closely, Ms. Hodges said.

Ms. Conte's attorney could not be

reached.

Elizabeth Ann Conte vs. Wyeth Inc., et al.; Court of Appeal of the State of California, First Appellate District,

Division Three; A116707, A117353; Nov. 7, 2008.

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