Supreme Court to hear case on generic drug labeling
■ Justices will decide if generic drugmakers are responsible for side-effect warning failures by brand-name companies.
By Alicia Gallegos — Posted March 21, 2011
Should generic drugmakers be liable for labeling errors made by brand-name companies?
It's a question the U.S. Supreme Court will examine March 30 when it hears arguments in the case of Mensing v. Pliva Inc. Gladys Mensing sued the generic drug company Pliva in 2005, claiming she developed the neurological disorder tardive dyskinesia after using metoproclamide to treat a gastric ailment.
Mensing also sued drug companies Schwarz Pharma and Wyeth, which manufactured the drug's brand-name equivalent, Reglan. Research showed that extended use of metoproclamide could result in tardive dyskinesia, but that warning was missing from the brand-name and generic drug labels, according to the lawsuit.
A similar case was consolidated with Mensing's for the Supreme Court's review.
Pliva officials say a federal law bars them from being held liable for labeling mistakes by brand-name companies. The law requires that generic drugs include only identical label warnings to brand-name drugs. Because Reglan did not include the warning on tardive dyskinesia, Pliva said the company cannot be blamed for any injuries that are associated with metoproclamide.
A lower court ruled in favor of Pliva, but the 8th U.S. Circuit Court of Appeals partially reversed the decision. The appellate court dismissed the brand-name companies from the lawsuit, ruling that they were not liable because Mensing never ingested their product. But the court said the generic drugmaker could have proposed a label change to the Food and Drug Administration.
"When a manufacturer has reasonable evidence of ... a serious hazard with a drug, the drug's label must be revised," the court said. "Manufacturers cannot distribute a misbranded drug. The FDA has several enforcement mechanisms to ensure that drugs with misleading labels are taken off the market."
Determining label liability
The Mensing case has generated much attention in the medical community and other industries that might be impacted by the ruling. Friend-of-the-court briefs were filed by the Litigation Center of the American Medical Association and the State Medical Societies, AARP, numerous pharmaceutical companies and 43 state governments, among others.
In its brief, supportive of Mensing, the Litigation Center said health care professionals and patients rightly expect drugs to be reasonably safe and aggressively tested by all drug manufacturers.
"Generic drugmakers should not be exempt from a duty to conduct continuous and affirmative pharmacovigilance of their products," the brief stated. "If this surveillance reveals information relevant to the safety of their drugs, they should take action to assure that this information is communicated to prescribers and their patients."
Generic drug companies argue that clinical trials and monitoring of drug research are the responsibility of brand-name companies.
"The whole case has the potential of putting an unfair burden on the generics," said Bob Billings, vice president of policy for the Generic Pharmaceutical Assn.
"We can't label for a risk that the brand name doesn't have on there."
Generic drug companies save money by not being required to conduct clinical trials, Billings said. If the Supreme Court rules against Pliva, he said, generic drugmakers will feel pressured to do their own testing, reducing the cost savings.
"They couldn't do clinical trials and not pass the cost on," he said. "It would increase generic prescription costs" for consumers.
But if the Supreme Court rules for Pliva, the decision would hurt consumers' ability to pursue legal remedies after being injured by generic drugs, said Louis Bograd, Mensing's attorney and senior litigation counsel for the Center for Constitutional Litigation, a civil rights law firm.
A lack of legal recourse against generic drug companies could put physicians at risk for more drug-related medical liability lawsuits, he said. Doctors also might feel forced to do their own research on drugs to inform patients of side effects not listed on drug labels, he said.
"If drug companies don't provide adequate warnings on their products, doctors can't make adequate prescribing decisions," Bograd said.