Reglan Maker Asks Ala. Supreme Ct. To Reconsider Innovator Liability

Pfizer is asking the Alabama Supreme Court to reconsider a recent ruling, which allowed a plaintiff to file a lawsuit against the manufacturer of name-brand Reglan as a result of side effects associated with use of a generic equivalent, under a theory of innovator liability. 

A request for a rehearing was filed on February 19. and is 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.

In January, the Alabama Supreme Court ruled that manufacturers of brand name medications can be held responsible for failing to warn about the risk of side effects associated with a drug, even if the plaintiff only took a generic version of the medication and not the actual brand name product.

The ruling came in a lawsuit filed against Pfizer by a man who took generic metoclopramide, which was sold by a Pfizer subsidiary as Reglan, and developed a movement disorder known as tardive dyskinesia.

Reglan is approved for the short-term treatment of gastrointestinal disorders, such as diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, it is often prescribed for longer periods of time due to the often chronic persistence of those ailments, which has left many users with the movement disorder tardive dyskinesia.

In February 2009, the FDA required the manufacturers of all medications containing metoclopramide to update the warning label to indicate that 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.

In its ruling, the Alabama Supreme Court determined that it was not unfair to hold brand name manufacturers accountable for the labels of generic drugs, since generic drugmakers are required by law to duplicate the brand-name warning label.

A prior ruling by the U.S. Supreme Court provided generic drug manufacturers with essential immunity from “failure to warn” lawsuits, under the theory that such claims are pre-empted by federal requirements that generic medications carry the exact same warning label that is provided with the name brand drug. Following the ruling, in a case known as Pliva v. Mensing, lawsuits pending against the manufacturers of generic Reglan and other medications have been dismissed throughout the country.

If the Alabama high court’s ruling stands, it could allow users who suffered injuries associated with generic medications to successfully pursue compensation against name-brand manufacturers in Alabama under the theory of innovator liability.

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 new side effects are linked to the drugs after they have gone generic. These changes may also allow consumers to file failure to warn lawsuits against generic drug makers throughout the country.