Adivided US Supreme Court ruled June 23 that federal law pre-empts lawsuits filed in state courts by individuals seeking damages from generic drug makers claiming they were inadequately warned of potential side effects. Under the new ruling, thousands of similar lawsuits filed in state courts must now be dismissed.
The Supreme Court case is unlikely to affect most patients or physicians, medical-legal experts told Neurology Today, but the ruling does provide clinicians with an important take-home message.
“The significance of this ruling lies at the systems level, but for the individual physician — a neurologist or otherwise, our obligation remains the same: to disclose to our patients all reported risks associated with any medication,” said Paul S. Appelbaum, MD, the Dollard Professor of Psychiatry, Medicine, & Law, and director of the Division of Law, Ethics, and Psychiatry at Columbia University College of Physicians & Surgeons in New York City.
Whether or not the information is included in the prescription packet insert warning, or has been reported in the medical literature and is not yet included, doctors are obligated to stay abreast of risks and need to discuss them with each patient, he said.
“If there is any disconnect here, we physicians must own it,” he told Neurology Today in a telephone interview.
In its 5-4 decision in Pliva Inc v. Mensing, the Justices reversed a US appeals court ruling that permitted a lawsuit filed in Minnesota against Pliva, part of Teva Pharmaceutical Industries Ltd, headquartered in Israel, which manufactures metoclopramide, the generic version of the brand name gastrointestinal drug Reglan. Damages have also been sought from generic manufacturers UDL Laboratories (Mylan), in Rockford, IL, and Iceland's Actavis Inc.
Gladys Mensing sued Pliva when she developed persistent tardive dyskinesia after taking its generic version of Reglan. Another patient with the same disorder filed a similar complaint in Louisiana. In both cases the women had taken the drug far longer than the FDA warning advised, but at the time the risk of movement disorders had not been clearly established.
As more evidence accumulated, the FDA ordered several changes in the labeling of Reglan, increasingly warning of such movement disorder risks with longer use. The generic companies argued that federal law pre-empts state lawsuits once the US FDA has approved a brand name medication's warning label because federal law requires all generics to carry the same warnings as the brand name product.
“This decision was divided between Justices who generally are pro-business and those who are generally pro-consumer, and the result was ridiculous,” Hank Greely, JD, the Deane F. and Kate Edelman Johnson Professor of Law, and director of the Stanford Center for Law and the Biosciences, told Neurology Today in a telephone interview. “It means that if you are injured after taking a brand name drug you can sue the manufacturer, but not if your doctor prescribes a generic or your pharmacist substitutes the generic version. To me, that is absurd.”
Nonetheless, he agreed that Pliva “is probably not very important” for individual doctors or patients because so few patients taking generics suffer serious side effects that are not listed as potential side effects on a product's label.
“By the time a generic version of a drug becomes available we pretty much know the potential risks,” he said.
“However, there is little legal recourse now available for those who do experience serious side effects from generics that may not have been listed as potential risks.”
Congress should better clarify the issue, Greely said, adding, however, that he doubts this will happen soon. “In the meantime, physicians are exposed to potential malpractice lawsuits by patients injured by generics,” he noted. “In a way, all of this leaves doctors high and dry.”
PAST RULINGS ON THE LABELING PRE-EMPTION ISSUE
The June 23 decision marks the third time since 2008 that the Supreme Court has issued seemingly contradictory decisions on the labeling pre-emption issue. In its 2009 decision in Wyeth v. Levine, the court ruled against drug manufacturers. [Neurology Today covered the decision: http://bit.ly/r0iOm5.]
One year earlier, in Riegel v. Medtronic, the high court held that makers of medical devices are exempt from state lawsuits. [See Neurology Today: http://bit.ly/qQywrs.]
In the initial FDA approved labeling for Reglan, the agency advised against using the medication for more than three months because treatment had not been evaluated for any period longer than that. In 2009 it ordered them to carry specific warnings about the risk of movement disorders.