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Name-Brand Drug Makers Ruled Liable for Injuries From Other Manufacturers' Generics
The Recorder
November 10, 2008
Drug manufacturers have long had to provide safety warnings for their products. Now they might have to do the same for companies piggybacking on their success.
On Friday, San Francisco's 1st District Court of Appeal stunned drug makers by ruling that they can be held liable not only for any harm caused by their own name-brand products, but also for injuries caused by competing companies' generic versions.
"As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs," Justice Peter Siggins wrote, "so too runs the duty of care."
Justices William McGuiness and Stuart Pollak concurred.
Product liability lawyers Mark Herrmann, a partner in Jones Day's Chicago office, and James Beck, counsel with Dechert in Philadelphia -- neither of whom was involved in the case -- responded quickly, saying that the ruling "stands product liability law on its head."
On their blog, Drug and Device Law, they wrote: "Only the manufacturer made a profit from selling the product, and only the manufacturer controls the safety of the product it makes, so only the manufacturer can be liable. Black letter law (and sound public policy), right? Not in California."
In a telephone interview, Herrmann said the 1st District broke from several other states to reach its conclusion. "Virtually all the precedents went the other way," he said.
The case involved New Jersey-based Wyeth Inc., which was sued in San Francisco by a woman named Elizabeth Conte. She claimed she developed a serious and irreversible neurological condition after long-term use of generic versions of Wyeth's Reglan, also known as metoclopramide, to treat gastroesophageal reflux disease.
Conte -- who sued for fraud and negligent misrepresentation -- argued that Wyeth should have had the duty to warn doctors that Reglan and its generic versions shouldn't be used for more than 12 weeks at a time. Conte took the drug for nearly four years.
San Francisco Superior Court Judge Robert Dondero granted summary judgment for Wyeth. But the appeal court reversed, calling the issue one of first impression.
"We believe California law supports Conte's position," Siggins wrote in Conte v. Wyeth Inc., 08 C.D.O.S. 13931, "that Wyeth owes a duty of care to those people it should reasonably foresee are likely to ingest metoclopramide in either the name-brand or generic versions when it is prescribed by their physicians in reliance on Wyeth's representations."
The appeal court, however, upheld summary judgment in favor of the generic manufacturers -- Pliva Inc., Purepac Pharmaceutical Co. and Teva Pharmaceuticals Inc. The justices said there was no evidence that Conte's physician relied on the generic companies' warnings before prescribing Reglan.
Berkeley, Calif., lawyer Laurence Masson, who was listed in court records as one of Conte's attorneys, didn't return a telephone call seeking comment late Friday afternoon.
Jeffrey Pilkington, a partner with Denver's Davis Graham & Stubbs who was one of Wyeth's lawyers, referred calls to the company's press office. A late call Friday to Wyeth spokesman Douglas Petkus in Madison, N.J., wasn't returned.
Product liability lawyers Herrmann and Beck predicted that the ruling will increase tensions between name-brand and generic manufacturers.
"Look for contribution/indemnity claims brought by pioneer manufacturers against generics to proliferate," they wrote in their blog. "It's the Hatfields versus the McCoys all over again."
On Friday, San Francisco's 1st District Court of Appeal stunned drug makers by ruling that they can be held liable not only for any harm caused by their own name-brand products, but also for injuries caused by competing companies' generic versions.
"As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs," Justice Peter Siggins wrote, "so too runs the duty of care."
Justices William McGuiness and Stuart Pollak concurred.
Product liability lawyers Mark Herrmann, a partner in Jones Day's Chicago office, and James Beck, counsel with Dechert in Philadelphia -- neither of whom was involved in the case -- responded quickly, saying that the ruling "stands product liability law on its head."
On their blog, Drug and Device Law, they wrote: "Only the manufacturer made a profit from selling the product, and only the manufacturer controls the safety of the product it makes, so only the manufacturer can be liable. Black letter law (and sound public policy), right? Not in California."
In a telephone interview, Herrmann said the 1st District broke from several other states to reach its conclusion. "Virtually all the precedents went the other way," he said.
The case involved New Jersey-based Wyeth Inc., which was sued in San Francisco by a woman named Elizabeth Conte. She claimed she developed a serious and irreversible neurological condition after long-term use of generic versions of Wyeth's Reglan, also known as metoclopramide, to treat gastroesophageal reflux disease.
Conte -- who sued for fraud and negligent misrepresentation -- argued that Wyeth should have had the duty to warn doctors that Reglan and its generic versions shouldn't be used for more than 12 weeks at a time. Conte took the drug for nearly four years.
San Francisco Superior Court Judge Robert Dondero granted summary judgment for Wyeth. But the appeal court reversed, calling the issue one of first impression.
"We believe California law supports Conte's position," Siggins wrote in Conte v. Wyeth Inc., 08 C.D.O.S. 13931, "that Wyeth owes a duty of care to those people it should reasonably foresee are likely to ingest metoclopramide in either the name-brand or generic versions when it is prescribed by their physicians in reliance on Wyeth's representations."
The appeal court, however, upheld summary judgment in favor of the generic manufacturers -- Pliva Inc., Purepac Pharmaceutical Co. and Teva Pharmaceuticals Inc. The justices said there was no evidence that Conte's physician relied on the generic companies' warnings before prescribing Reglan.
Berkeley, Calif., lawyer Laurence Masson, who was listed in court records as one of Conte's attorneys, didn't return a telephone call seeking comment late Friday afternoon.
Jeffrey Pilkington, a partner with Denver's Davis Graham & Stubbs who was one of Wyeth's lawyers, referred calls to the company's press office. A late call Friday to Wyeth spokesman Douglas Petkus in Madison, N.J., wasn't returned.
Product liability lawyers Herrmann and Beck predicted that the ruling will increase tensions between name-brand and generic manufacturers.
"Look for contribution/indemnity claims brought by pioneer manufacturers against generics to proliferate," they wrote in their blog. "It's the Hatfields versus the McCoys all over again."
