In the drug liability arena, the questions of federal pre-emption and generic drug maker liability arose in landmark rulings of 2008 and 2009. In November, the 8th Circuit revisited both issues in Mensing v. Wyeth.

In the pre-emption case Wyeth v. Levine, the U.S. Supreme Court in March 2009 rejected Wyeth’s defense that FDA approval of drug labeling pre-empted state failure-to-warn claims. The high court wrote that the pre-emption defense was a “cramped reading” of the FDA’s regulations concerning changes to drug labels.

And the November 2008 California appellate ruling in Conte v. Wyeth got attention for its pure novelty, as the state became the first in the nation to embrace innovator liability–the idea that brand-name makers can be held liable for injury a generic version caused–in a negligent misrepresentation case involving a plaintiff injured by a generic drug.

Mensing makes the 8th Circuit the first federal appellate court to reject Conte–as well as the first to take up the question of innovator liability in 15 years and the first to apply Levine, the most important drug ruling of 2009, in the generic drugs context. For brand name makers, Mensing assures that the logic (or illogic) of Conte will not spread, and for generics it cautions not to expect special treatment with regards to Levine‘s application.

Presumption Against Pre-Emption

Gladys Mensing took metoclopramide, a generic form of Wyeth’s Reglan, for four years before she developed tardive dyskinesia, a neurological disorder that causes uncontrollable bodily movements. Mensing sued the generic manufacturers and distributors, as well as the name brand manufacturers Schwarz Pharma Inc. and Wyeth, alleging failure to warn and negligent misrepresentation. Her claim was similar to Elizabeth Conte’s, the plaintiff in the 2008 ruling on innovator liability: that, despite “mounting evidence that long term metoclopramide use carries a risk of tardive dyskinesia far greater than indicated on the label, no metoclopramide manufacturer took steps to change the label warnings,” as the 8th Circuit wrote.

At trial, the U.S. District Court for the District of Minnesota granted motions to dismiss and summary judgment to the generic defendants on grounds of federal pre-emption, ruling the failure to warn claims were in conflict with federal law because they would force the generics to deviate from the name brand drug label. The district court also granted summary judgment to Schwarz Pharma and Wyeth, holding that because Gladys Mensing never ingested their products, they owed her no duty of care.

On appeal, the 8th Circuit affirmed summary judgment for the brand name manufacturers but reversed the judgment in favor of the generics.

Addressing the pre-emption argument, the court wrote that the drug maker defendants failed to show it was impossible to comply with both the state and federal laws. The generics could have, for instance, contacted the FDA to request a label change. Since they didn’t make such a request, it was impossible to know how the FDA would have acted, but the court relied upon the “presumption against pre-emption” that Levine set forth (see “Even Playing Field”).

“I can’t say [Mensing] is unexpected after Wyeth v. Levine,” says James Beck, counsel at Dechert and co-founder of the Drug and Device Law Blog. “The [Levine] court erected a very strong standard of impossibility, and I haven’t seen a good response to those arguments.”

Casting Aside Conte

Next the court rejected Conte, the California ruling that allowed a claim against the name-brand drug maker because the plaintiff’s physician had relied upon information provided by the name-brand drug maker–despite the fact that the plaintiff only ingested the generic version.

The appeals court said the plaintiff couldn’t assert the traditional product liability claim against Wyeth because the plaintiff had not ingested Wyeth’s product, but the court allowed to proceed a separate misrepresentation claim against Wyeth.

With the generics market booming, Conte had vast implications. But few thought it would become the status quo.

“This was viewed as a terrible decision because it exposed brand name manufacturers to potentially unlimited liability,” says William Ruskin, a member at Epstein Becker & Green. The generic could gain 90 percent of the market yet the brand name manufacturer retains 100 percent of the liability, he says.

Indeed, the 8th Circuit cited Conte merely as an outlier that “stretches the concept of foreseeability too far.”

Although Mensing‘s rejection of innovator liability comes as a surprise to few pharmaceutical defense lawyers, it softens the blow of the polarizing Conte.

Mensing is extremely significant because the 8th Circuit became the first federal appellate court to reject the California decision in Conte v. Wyeth,” Ruskin says. “The court points out that there are 20 states around the country that have rejected the idea of innovator liability. The importance of Mensing is that there will not be a wildfire of innovator liability spreading east from California.”