government

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

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

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.

Back to top


External links

Gladys Mensing v Wyeth Inc. and Pliva Inc., et al., U.S. Court of Appeals for the 8th Circuit, filed Nov. 27, 2009 (link)

Back to top


ADVERTISEMENT

ADVERTISE HERE


Featured
Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story


Read story

Goodbye

American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story


Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story


Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story


Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story


Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story


Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story


Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story