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Generic drug liability ruling raises concerns

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Generic drug liability ruling raises concerns

An Alabama Supreme Court ruling that says brand-name drug makers can be held liable for injuries caused by drugs produced by generic manufacturers could have a significant effect on other pharmaceutical cases, and even on product liability litigation not pharmaceutical related, legal experts say.

Others dismiss the importance of the Jan. 11 ruling in Wyeth Inc. et al. v. Danny Weeks and Vicki Weeks, stating it was issued by a noninfluential court, and is an outlier ruling that is contrary to the overwhelming majority of other decisions on the issue.

The underlying case involved a patient who developed tardive dyskinesia, a condition that causes involuntary movements, after his long-term use of the prescription heartburn drug metoclopramide, a generic form of the brand-name drug Reglan that was produced by Wyeth Inc. Wyeth has since been acquired by New York-based Pfizer Inc.

Experts say the Alabama ruling reflects two conflicting issues. On one hand, it may be unfair for brand name manufacturers to be held liable for a drug they never produced. On the other hand, innocent victims of harmful drugs should have recourse when hurt by drugs the brand name manufacturers originally developed.

Meghan A. McCaffrey, an associate with Weil, Gotshal & Manges L.L.P. in Washington, said the Alabama ruling “was a results-driven decision. I think the Alabama court wanted to give the plaintiffs an opportunity for relief of some sort and, quite frankly, I think they pushed it a little bit with this case.”

Michael A. Walsh, a partner with Dallas-based Strasburger Price L.L.P., said this is the first time a state Supreme Court has ruled on this issue. “That becomes something that other courts are going to take seriously,” he said.

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While plaintiff attorney Michael L. Murphy, with Bailey & Glasser L.L.P. in Washington, said the ruling is unlikely to become a majority view, “I think it could get enough traction to at least take hold in a number of jurisdictions.”

However, James M. Beck, counsel at Reed Smith L.L.P. in Philadelphia, said the ruling is unlikely to be influential. “I don't think it's particularly persuasive. It's not like it's the New York Court of Appeals,” which is more prestigious, or a court that “has me shaking in my boots.”

For its part, Pfizer said in a statement that 76 court decisions that apply 25 states' laws have held that brand name pharmaceutical manufacturers “may not be held liable, on any theory, for injuries caused by products they did not manufacture.” Furthermore, the four federal appellate courts that have addressed the issue “rejected the assertion brand manufacturers can be held liable for injuries caused by a plaintiff's ingestion of generic metoclopramide,” Pfizer's statement said.

Some experts say it is unjust to have brand name drug makers be liable, even as they lose market share to generic drug producers. It is not unusual for branded drug makers to retain only a 20 % to 30% market share after their patents expire, said Erin M. Bosman, a partner with Morrison & Foerster L.L.P. in San Diego.

This presents a challenge for underwriters in determining how to write the risk, said James W. Huston, a San Diego-based Morrison & Foerster partner.

While some say the ruling could affect nonpharmaceutical-related product liability, William A. Ruskin, a member of Epstein Becker & Green P.C. in New York, doubted that because it “is such an outlier decision.”