Fifth Circuit backs shield against branded pharma's liability for generic harms

The court fight over Pfizer's ($PFE) stomach drug Reglan (metoclopramide) has yielded another ruling in Big Pharma's favor. Once again, a U.S. court has ruled that branded drugmakers can't be sued for damages allegedly caused by generic versions of their drugs.

The Fifth Circuit upheld a decision shielding Pfizer's Wyeth unit and fellow branded drugmaker Schwarz Pharma from claims that generic copies triggered injuries in some patients, Law360 reports.

The appellate panel's ruling follows a similar decision in the Ninth Circuit. That three-judge panel upheld a lower court's choice to toss out claims against Wyeth and Schwarz, in a case over neurological problems allegedly caused by generics maker Pliva's version of metoclopramide.

But the trend isn't all in brand-makers favor. Alabama's state supreme court decided generics patients could indeed sue Pfizer over injuries allegedly caused by Reglan. Pfizer asked for a rehearing in that case last February, and in June, that court granted the request. Oral arguments took place in September. Meanwhile, California and Vermont appeals courts have upheld some "innovator liability."

The litigation stands to affect all branded drugmakers, of course, because if generics patients can sue them for damages, that's a big potential cost.

The FDA is proposing a new route to clarity, though. The Alabama decision, for one, turned on the agency's rule that generics makers use the same exact label as the branded drugmakers do. The FDA proposed a new rule on generic labeling that would allow copycat drugmakers to change their labels even if the branded drug's label remains the same. Generics makers are emphatically not in favor.

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