After a Philadelphia judge ruled that the brand-name maker of Ambien can’t be held responsible for the label on a generic version of the drug, the plaintiff’s lawyer in the case said he would advise his client it would be impossible to prosecute the claim in the wake of the U.S. Supreme Court’s ruling that federal law pre-empts failure-to-warn claims regarding generic drugs.
Plaintiff’s counsel Brian D. Witzer of the Law Offices of Brian D. Witzer in West Hollywood, Calif., said he will have to tell his client that the Pliva v. Mensing decision “is going to keep him from the gates of justice, period. That decision … so undermines a plaintiff’s right to recover and on such, in my view, a marginal legal basis, it basically says the generic manufacturer has no responsibility to keep a safe product.”
Brand-name manufacturers, once their trademarks end and they get out of the business, have “no responsibility whatsoever for the product,” Witzer argued.
The Supreme Court ruled in Mensing that a plaintiff’s claims that a generic drugmaker failed to warn adequately of the potential risks of taking a generic version of a drug are pre-empted by federal law because it would be impossible for generic drugmakers to comply both with a federal duty to keep their labels the same as brand-name labels and state-law duties to change their labels.
Dissenting Justice Sonia Sotomayor countered in dismay that the decision would affect 75 percent of the American prescription drug market involving generic versions of drugs and “a drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic.”
Plaintiff Stephen M. Madden had his prescription for Ambien, a sleep-inducing drug, filled with a generic version of the drug made by Teva Pharmaceuticals USA Inc. on October 1, 2008, in Redding, Calif., according to the opinion. Sanofi-Aventis makes the brand-name Ambien.
The Ambien prescription was written by a Washington state physician after Madden had a knee replacement in his right leg, the opinion said. While using the prescription, Madden said he sleep-drove, crashing his vehicle at a high rate of speed into an electric pole and a tree, and then was ejected from his vehicle.
Sanofi-Aventis got out on preliminary objections, while Teva Pharmaceuticals got out on a motion for judgment on the pleadings.
If California law applied, then Madden might be able to make out a claim because an intermediate California appellate court said in Conte v. Wyeth that brand-name manufacturers may be liable for generic versions of their drugs, Witzer said.
California is in the minority, according to the case law compiled in the Philadelphia judge’s opinion.
Philadelphia Court of Common Pleas Judge Allan L. Tereshko, writing in an October 1 opinion, said that more than 40 cases in approximately 20 states have held that brand-name manufacturers are not liable for injuries allegedly caused by the use of a generic drugmaker’s product.
“Plaintiff has specifically alleged that Teva, not Sanofi, manufactured the product ingested by the plaintiff,” the opinion said. “As such, plaintiff has failed to state a legally sufficient claim against Sanofi.”
Tereshko also concluded that Washington law, not California law, applied to Madden’s claims.
The drug was prescribed in Washington, and the duty to warn lies in Washington, so Madden’s claims are barred by the stance in Washington law that the actual drugmaker of the drug Madden took must be sued, Witzer said.
Washington has a greater interest in applying its law over California, forum state Pennsylvania or New Jersey, where Sanofi said it’s headquartered, Tereshko said.
“The decision to prescribe Ambien was made in Washington, the prescription was written in Washington, and any warnings to the doctor would necessarily have been received in Washington,” Tereshko reasoned.
Permitting the “significant expansion of liability” advocated by Madden’s counsel would be in direct contrast to the Washington Product Liability Act, which was “‘designed to address a liability insurance crisis which would threaten the availability of socially beneficial products and services,’” according to the opinion.
That act only allows products liability claims against manufactures or sellers of the product, Tereshko said.
While Witzer’s firm filed a notice of appeal on behalf of Madden, Witzer said he would advise his client that his claims can’t be prosecuted further.
Local plaintiff’s counsel is Joseph P. Grimes of Grimes & Grimes.
Alice Sacks Johnston, Teva Pharmaceuticals’ counsel with Obermayer Rebmann Maxwell & Hippel, and Kenneth A. Murphy, Sanofi-Aventis’ counsel with Drinker Biddle & Reath, did not respond to requests for comment.
(Copies of the 12-page opinion in Madden v. Teva Pharmaceuticals USA, PICS No. 12-1949, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •