Gladys Mensing has diabetes. When her doctor prescribed the drug Reglan to treat some of her symptoms, she began taking its generic equivalent. Four years later, Mensing developed a severe neurological disorder caused by the long-term use, which went unwarned on the generic drug’s label.
Mensing developed tardive dyskinesia (TD) after taking the generic equivalent of Reglan. Much like Parkinson’s Disease, TD is a severe neurological disorder characterized by involuntary movements of the mouth, tongue, lips and extremities; involuntary chewing movements; and a general sense of agitation.
In accordance with Minnesota law, where Mensing lives, her pharmacy filled her prescription with Reglan’s generic equivalent, metaclopramide, which she proceeded to take for the next four years.
While the FDA described metaclopramide as “short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy,” it wasn’t until 2004, three years after Ms. Mensing started taking metoclopramide, that a warning -- “Therapy should not exceed 12 weeks in duration” -- was added to the drug’s label.
Mensing sued the manufacturers of both the brand name and the generic form of the drug for failure to adequately warn of the risks of long-term use. She argued that despite mounting evidence of the risk of developing TD, no metoclopramide manufacturer took steps to change the label warnings. She alleged that some manufacturers even promoted long-term use.
But a Minnesota district court ruled in 2008 that Mensing’s claims against the drug manufacturers were preempted by the federal regulations regarding generic drugs. The court also ruled that Mensing could not sue the manufacturers of Reglan, because under Minnesota law drug companies owe no duty to persons who do not take their product specifically. Public Justice’s initial appeal in the Eighth Circuit challenged both rulings.
The case brought into question two important legal issues for the Eighth Circuit Court of Appeals to decide: the preemptive effect of federal regulations of generic drugs on state tort liability and the liability of name-brand drug companies for misrepresentations that foreseeably result in physical injury to third parties.
The Eighth Circuit’s resulting opinion held that the plaintiff’s claims against the generic manufacturers of metaclopramide are not preempted by federal law but affirmed the dismissal of Mensing’s claims against the manufacturer of name-brand Reglan.
The Supreme Court subsequently granted review and reversed the Eighth Circuit Court of Appeals, ruling in June 2011, by a 5-4 vote, that generic drug manufacturers cannot be sued for failing to warn patients or doctors of their drugs' dangers -- even though the Court ruled previously, in Wyeth v. Levine, that name-brand drug manufacturers can be sued for failing to warn patients or doctors of their drugs' dangers.
In the Supreme Court's decision, the five majority voters said that state failure-to-warn claims against generic drug manufacturers are preempted by federal law.
As a result, when pharmacies fills prescriptions by substituting generic drugs for name-brand (as most states require them to do), consumers will be losing their rights in the process.
Public Justice Staff Attorney Claire Prestel joined Louis Bograd of the Center for Constitutional Litigation as lead appellate counsel in Gladys Mensing's case against the metaclopramide manufacturer.