In a devastating opinion for consumers, the Supreme Court has ruled that generic drug companies can not be held liable for failing to warn about known side effects of medications they sell, so long as their labels are identical to those of the original brand-name product. The ruling may have an impact on thousands of generic drug lawsuits filed throughout the United States, involving problems with generic versions of drugs like Reglan, Accutane, Darvocet, Zocor and others.
The 5-4 decision in Pliva Inc. v. Mensing was handed down by the Supreme Court today, split along ideological lines among the justices.
The case involves a lawsuit filed by two women against generic manufacturers of metoclopramide, known more commonly by its brand name, Reglan. The two women, Julie Demahy and Gladys Mensing, sued Actavis, Teva Pharmaceutical Industries, Mylan and other generic drug makers for failing to warn that generic Reglan carried a risk of a rare movement disorder known as tardive dyskinesia.
The generic drug makers filed the appeal to the U.S. Supreme Court, arguing that the generic drug lawsuit should be pre-empted because federal law prohibited them from deviating from the original Reglan prescribing labels. Therefore, they claimed that they should be immune from a lawsuit for failing to adequately warn about the risk of tardive dyskinesia from Reglan.
Although plaintiffs argued that the drug makers had other avenues of warning, such as “dear doctor” letters, the Supreme Court overturned a lower court ruling and found that the plaintiffs’ claims were pre-empted by federal law.
The conservative justices agreed with drug manufacturers, and ruled that generic drug makers were isolated from consumer lawsuits as long as they cloned previous drug labels. Justice Clarence Thomas, who wrote the opinion for the majority, said it was impossible for drug manufacturers to follow federal laws requiring duplicate labels while also following state laws requiring safer warnings. Thomas wrote that states laws have to give way to federal power in this case, despite any potential risks to consumers.
Plaintiffs argued against that interpretation of the laws, saying that generic drug manufacturers could have simply asked the FDA to allow them to put more stringent warnings in place in other ways. The FDA has indicated that regulations exist that require generic drug manufacturers who become aware of problems to “ask the agency to work toward strengthening the label that applies to both the generic and brand-name equivalent drug,” but Thomas wrote that the test for whether the laws are impossible to follow require that the manufacturers be able to meet both state and federal standards without outside assistance.
FDA officials argued that all generic drug manufacturers have to do is call and the FDA will determine if updated labels are needed, but Thomas rejected that argument, saying the court would not address it because it has already determined that pre-emption conditions exist.
“We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated,” Thomas wrote, but went on to state that it is not the court’s job to decide if regulations passed by Congress are unusual or bizarre.
Thomas specified that the ruling does not contradict an earlier Supreme Court judgment in Wyeth v. Levine, which found that brand-name drugs were not exempt from product liability lawsuits, because they could easily meet both state and federal laws without conflict.
Justices Sonia Sotomayor, Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan dissented with the ruling, siding with the protection of the public from potentially dangerous drugs as the higher priority for the court.
“We have traditionally held defendants claiming impossibility to a demanding standard,” Sotomayor wrote for the dissenting judges. “Until today, the mere possibility of impossibility had not been enough to establish pre-emption.”
Sotomayor pointed out that there was a mechanism in place to avoid impossibility through the FDA and accused conservative justices of straining legal interpretation to the detriment of consumers and the advantage of pharmaceutical companies.
“The Court gets one thing right,” Sotomayor wrote. “This outcome makes little sense.”
Tardive dyskinesia is a rare movement disorder associated with repetitive and involuntary movements, particularly involving the lower face and limbs. Symptoms can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. Long-term use of Reglan has been linked to an increased risk of tardive dyskinesia and there is no known effective treatment of the disorder, with the involuntary movements often persisting even after use of the drug has stopped.
A number of similar tardive dyskinesia lawsuits over Reglan are pending in courts throughout the United States against generic drug makers. Brand-name Reglan was originally formulated and marketed by Wyeth, but it is currently only available as a generic metoclopramide.
In February 2009, the FDA required that manufacturers of all variations of generic metoclopramide add a black box warning about the Reglan tardive dyskinesia risk, which is the strongest warning that can be placed on a prescription medication. The generic drug makers were also required to develop mitigation and risk evaluation strategies to help ensure patients are aware of the potential metoclopramide side effect.
Although the first Reglan tardive dyskinesia lawsuit was filed in 1998, the number of claims has increased since the black box warning was added. The ruling is likely to have an impact on thousands of generic Reglan lawsuits that are pending in cases throughout the United States.
The Supreme Court ruling may also impact lawsuits filed by consumers who were injured by undisclosed side effects of other generic medications. In recent years, a number of generic Accutane lawsuits have been filed against drug makers for failing to warn about the risk of inflammatory bowel disease from the acne medication. Generic Darvocet lawsuits have been filed on behalf of consumers who suffered severe heart problems as a result of the popular painkiller, which was recalled last year. More recently, a number of consumers have been reviewing potential generic Zocor lawsuits as a result of inadequate warnings that high doses of the cholesterol drug have been associated with an increased risk of a serious and potentially life-threatening muscle injury, known as rhabdomyolysis.