Innovator Liability Ruling to be Reconsidered by Alabama Supreme Court

The highest court in the state of Alabama has agreed to reconsider a recent ruling that allowed a consumer to pursue a product liability lawsuit against a brand-name drug maker for injuries that were suffered following use of a generic equivalent manufactured by another company.  

The Alabama Supreme Court has granted Pfizer a rehearing on a ruling in a generic Reglan lawsuit, which alleged the manufacturer of the brand name medication should be held responsible for failure to warn about potential side effects associated with the medication under the legal theory of “innovator liability”.

Even though the plaintiff only used a generic version of metoclopramide, which Pfizer’s Wyeth subsidiary first introduced under the brand name Reglan, the Alabama Supreme Court ruled in January that the case may move forward against the original developer of the drug for failing to adequately warn about the risk of users developing a rare and debilitating disorder known as tardive dyskinsesia, which involves involuntary muscle movements.

The state court’s decision came in the wake of a U.S. Supreme Court ruling in the case of Pliva vs. Mensing, which essentially gave generic drug manufacturers immunity from “failure to warn” lawsuits on the basis that such claims are pre-empted by federal requirements that generic drug labels be exact duplicates of brand name warning labels, even if the generic drug maker fails to warn about known risks that are not disclosed on the label of the brand-name medication.

The FDA is currently considering new regulations that would address the Supreme Court ruling and specifically require generic drug manufacturers to update their labels when they discover potential side effects that may be linked to the drugs they sell.

Under the “innovator liability” theory, plaintiffs have maintained that even if failure to warn cases against generic drug makers are barred, brand name drug manufacturers still owed a duty of care to consumers that never used the product manufactured and sold by that company.

Plaintiffs allege that Pfizer’s Wyeth subsidiary, as the innovator of the brand-name medication, knew or should have about the risk of tardive dyskinesia from Reglan, and withheld information from consumers and the medical community.

Pfizer filed a request for rehearing in February, accompanied by supporting briefs from the pharmaceutical industry, the U.S. Chamber of Commerce and other business interests. The briefs claim that if the ruling is allowed to stand, it will drive business and jobs away from Alabama.

Reglan (metoclopramide) was first approved in 1979 for the short-term treatment of gastrointestinal disorders, such as diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, it has often been prescribed for longer periods of time due to the often chronic persistence of those ailments, which studies now suggest may cause users to face an increased risk of developing the movement disorder tardive dyskinesia.

Since the mid-1980s, generic Reglan has been widely available and the brand-name version medication was discontinued in 2008.

The FDA required all manufacturers of metoclopramide-based medications to update the warning label in February 2009, indicating users may face an increased risk of tardive dyskinesia when the medications are used at high doses or for a long period of time.

Symptoms of tardive dyskinesia can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the socially debilitating disorder, and the involuntary movements can be permanent, persisting even after use of the drug has stopped.