Alabama Supreme Court redux: Pfizer can be sued for generic Reglan harms

The Alabama Supreme Court won't back away from a controversial ruling against Pfizer, in a liability case closely watched by the rest of the pharma industry.

Last year, the court decided Pfizer ($PFE) could be sued for damages allegedly wrought by its Reglan stomach drug, even though the plaintiff only took generic versions. Pfizer asked for a rehearing, and reargued its case last fall. But to no avail: A majority of justices on the appeals panel still ruled against the drugmaker.

At issue in this and other similar cases is this: Branded drugmakers are responsible for the official labeling on their drugs. Under federal law, generics companies must use the same labeling on their copies. Even if branded drugmakers' warnings fall short, generics makers can't tweak the official labels. The U.S. Supreme Court has ruled that generics makers can't be held liable for faults in the warning labels because they have no power to change them.

Most courts, including the Fifth and Ninth Circuit Courts of Appeals, have come down on Pfizer's side of the matter, saying the branded drugmaker shouldn't be held liable for damages allegedly caused by generic versions of Reglan. So, the Alabama case has been in the spotlight as an anomaly in the litigation. Plaintiffs Danny and Vicki Weeks have argued--and the state's high court has agreed--that branded drugmakers can be held culpable for failing to warn about side effects, because they're the only conduit for labeling changes.

Associate Justice Glenn Murdock

As the Associated Press notes, the court pulled its previous ruling, but the majority's new opinion hews closely to the previous decision. Three of the justices dissented, however, including Associate Justice Glenn Murdock, who wrote, "This court creates a precedent that poses danger for the prescription-medicine industry, and, by extension, for all industry."

For its part, Pfizer called the ruling "an outlier," citing decisions in a host of other courts, including 6 federal courts of appeals, Pharmalot notes. "Those courts have recognized that subjecting brand-name manufacturers to perpetual liability for injuries resulting from generic products would stifle innovation," the company said in a statement.

The FDA could step in and obviate the court fights. The agency has proposed new rules allowing generics makers to modify their drug labels even if the branded drugmaker doesn't. Generics companies are fighting the proposal, because it would make them responsible--and liable--for the labeling.

Now, it's the facts of this case that will be up for debate, with the Weekses on one side, and Pfizer and several generics makers on the other. Other plaintiffs may follow the Weeks couple to Alabama, to file their own suits against branded drugmakers. So suggests one plaintiffs' lawyer, in any case. That prospect will keep Pfizer's case--and Alabama's high court--under watchful eyes.

- see the AP story
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