Supreme Court Decision Could Have Big Impact on Consumer Rights
In a recent decision which has largely gone unnoticed outside the legal and pharmaceutical industries, the U.S. Supreme Court has ruled that generic drug manufacturers can not be held liable under state law for inadequate safety labels. The case is Pliva, Inc. et al v. Mensing and the Supreme Court issued its opinion on June 23, 2011.
Ron Brown, partner at Brown & Crouppen, an injury law firm based in St. Louis, Missouri, says the decision “abandons consumer safeguards in favor of generic drug companies.” According to Brown, generic drug manufacturers can now “escape any responsibility for failing to warn the public about the dangers their drug may pose.”
In 1984, Congress passed the Hatch-Waxman Amendments, which were designed to allow generic drugs quicker access onto the market. Federal law requires name-brand drug manufacturers to prove that their proposed label is both accurate and adequate. Under Hatch-Waxman, however, generic drug manufacturers only have to show that the generic drug label is identical to the name-brand drug label.
Metoclopramide and Tardive Dyskinesia
Tardive dyskinesia is a severe neurological syndrome of repetitive, involuntary movements of the tongue, face and extremities. Patients who suffer from tardive dyskinesia are unable to prevent purposeless movements, such as grimacing, lip smacking, puckering or pursing of the lips, rapid eye blinking or rapid movement of extremities, such as flapping their hands.
According to the FDA, long-term use of Reglan or its generic equivalents is the most common cause of drug-induced movement disorders, even after the patient stops taking the medication.
The plaintiffs in the recent Supreme Court case were prescribed the name-brand drug Reglan in 2001 and 2002. Their pharmacists, however, substituted the generic drug metoclopramide. The plaintiffs took the generic drug as prescribed for several years and subsequently developed tardive dyskinesia. The plaintiffs sued the generic manufacturers in state courts, alleging that the labels violated state laws for failing to warn of the risks of tardive dyskinesia.
The manufacturers appealed the lawsuits up to the U.S. Supreme Court, arguing that state “failure to warn” laws conflicted with the Food and Drug Administration’s labeling requirements. The manufacturers raised an “impossibility” defense-that it was impossible to comply with both the federal regulations and with the various state laws. They argued that federal regulations required their labels to be identical brand-name drugs, making it impossible to comply with tougher “failure to warn” state labeling laws. On the other hand, if they complied with the tougher state labeling laws, they would no longer be in compliance with federal labeling regulations.
At no point did the manufacturers inform the FDA about newly discovered health risks. The FDA told the Supreme Court that the manufacturers were required to propose stronger warning labels to the FDA if they believed such warnings were necessary. The FDA also informed the court that they would have worked with the brand-name manufacturers to create a new label for both the brand-name and the generic drug.
In a 5-4 decision, the Court sided with the manufacturers. Justice Thomas, writing for the majority, held that, “even had [the manufacturers] fulfilled their federal duty to ask for FDA help in strengthening the…label, they would not have satisfied their state tort-law duty.” Therefore, the court held that the federal law pre-empted the state laws.
An absurd result
The Court’s decision “has the absurd result of creating two classes of plaintiffs,” says Brown, “those harmed by name-brand drugs and those harmed by generics.”
The Court explicitly acknowledged that if the plaintiffs had been given the brand-name prescribed by their doctors, instead of the generic equivalent substituted by their pharmacists, they would have a remedy available to them. Thomas, however, wrote off that result by stating that, “it is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre.”
The potential implications for the U.S. healthcare system are enormous. As pointed out in the dissent by Justice Sotomayor, many name brand manufacturers simply quit making the drug after the generics are introduced onto the market. In 2009, seventy-five percent of all filled prescriptions were generic medications. The decision, according to Sotomayor, “leads to so many absurd consequences that I cannot fathom that Congress would have intended to pre-empt state law in these cases.”
Brown wondered what effect the decision would have on patients and doctors as its implications worked their way through the medical industry. “Justice Sotomayor noted that the decision removes any real incentive for generic drug manufacturers to monitor the safety of their products. Will doctors prescribe generics as often? What happens to the patient who lives in a state where generic substitutions are required by law? Or who has an insurance policy that requires generic substitution? Is the only recourse to take shoddy medication or not take it at all?”
Brown’s biggest concern, however, is for patients who have become disabled due to a generic drug injury. “These are not minor injuries-they are life-altering, disabling injuries. Many of these patients can no longer work. They need significant state and federal aid. The Supreme Court just transferred the financial responsibility away from the manufacturers who caused the injuries and gave American taxpayers the bill.”
Brown also noted the irony that, because these patients are often on state or federal aid, “they are required by law to take generics, placing them at even further risk of injury. The Court has essentially abandoned their safety to the generic drug industry.” Until the full implications of Pliva v. Mensing are known, Brown has this advice for anybody who is given a prescription. “Demand name-brand.”