In a much-anticipated ruling, the U.S. Supreme Court held on June 23, 2011 that consumers injured or killed by defective drugs have no failure to warn claim against generic drug manufacturers. The case, Pliva v. Mensing, was argued before the Supreme Court on March 30, 2011.
In Mensing, the plaintiff, Gladys Mensing, used the drug Metoclopramide, a generic version of the Wyeth drug Reglan. After prolonged use of the drug for treatment of her stomach disorder, Mensing, like many others, developed Tardive Dyskinesia, a devastating and permanent neurological disorder that causes involuntary muscle movement, particularly in the face. As a result, she lost control of the muscles in her face, tongue, arms and legs, rendering her helpless and unable to speak.
Mrs. Mensing sued Wyeth and the generic manufacturer in 2007, alleging that they failed to adequately warn users of the drug of the risks of contracting Tardive Dyskinesia. Later, in February 2009, the FDA forced the manufacturers of this drug to issue a “black box” warning, the strongest warning possible, warning users of their drug of the risk of contracting this terrible disease. For Gladys Mensing, it was too little, too late.
Unfortunately, after Mensing filed suit, the federal court dismissed her case, holding that Wyeth was not liable because Mensing did not take its drug, Reglan, but instead took a generic version of the drug manufactured by other companies. As to the generic manufacturers who actually made the drug she took, the court held that they could not be held liable for failing to change their drug label to warn of the risks of Tardive Dyskinesia because they were legally required to use the exact same warnings and labels used by the non-generic manufacturer, Wyeth, whose label similarly carried no warnings regarding Tardive Dyskinesia.
In an opinion released in November 2009, the Eight Circuit Court of Appeals partially reversed the holding of the lower court, ruling that the generic manufacturers could be held liable for a failure to warn. In rendering its decision, the court held that the law “does not permit generic manufacturers passively to accept the inadequacy of their drug’s label as they market and profit from it.” Mensing v. Wyeth, 588 F.3d 603, 608 (8th Cir. 2009). Following this opinion, the drug manufacturers appealed to the U.S. Supreme Court.
On June 30, 2011, the U.S. Supreme Court, in a 5 to 4 opinion, ruled in favor of the drug companies, finding that federal law bars failure to warn claims against generic drug companies because they are unable to change their warnings in light of the requirement that their labels be identical to the labeling used by the name brand drug companies. The court rejected the notion that generic drug companies could comply with state law requiring them to warn of all known dangers of their product while still complying with federal law requiring their label to match those of the name brand manufacturers by:
- Asking the FDA for permission to strengthen the warnings;
- Providing information to the name-brand drug manufacturer and ask them to take the necessary steps to strengthen the warnings;
- Sending “Dear Doctor” letters to health care professionals and pharmacies warning them directly of the risk at issue; or
- Unilaterally strengthening their warnings without prior FDA approval, knowing that the FDA would be extremely unlikely to penalize them for adding additional warnings to their product.
The court also rejected a strict application of the doctrine known as “impossibility pre-emption,” which holds that a state law is pre-empted when it is impossible for a defendant to comply with both the state law and a conflicting federal law. Historically, to invoke this defense, a defendant was required to show that it was literally “impossible” to comply with both state and federal law. The plaintiff in Mensing argued that the Defendants could not meet this high burden because they had never asked the FDA for permission to strengthen their warnings and could therefore not show that it was truly impossible to do so. The majority sidestepped this issue by claiming that the Defendants had not been sued for failing to seek permission to change their label, but for failing to actually change their label. In her dissent, Justice Sotomayor took issue with this approach:
Impossibility pre-emption, we have emphasized, “is a demanding defense.” Because pre-emption is an affirmative defense, a defendant seeking to set aside state law bears the burden to prove impossibility. To prevail on this defense, a defendant must demonstrate that “compliance with both federal and state [law] is a physical impossibility.” In other words, there must be an “inevitable collision” between federal and state law. “The existence of a hypothetical or potential conflict is insufficient to warrant” pre-emption of state law. In other words, the mere possibility of impossibility is not enough.
The Manufacturers contend that it was impossible for them to provide additional warnings to respondents Mensing and Demahy because federal law prohibited them from changing their labels unilaterally. They concede, however, that they could have asked the FDA to initiate a label change. If the FDA agreed that a label change was required, it could have asked, and indeed pressured, the brand-name manufacturer to change its label, triggering a corresponding change to the Manufacturers’ generic labels. Thus, had the Manufacturers invoked the available mechanism for initiating label changes, they may well have been able to change their labels in sufficient time to warn respondents. Having failed to do so, the Manufacturers cannot sustain their burden (at least not without further factual development) to demonstrate that it was impossible for them to comply with both federal and state law. At most, they have demonstrated only “a hypothetical or potential conflict.”
Id. at *51-52.
The majority also sidestepped another important issue: if a generic drug company cannot change their warnings, they can always simply make the decision not to sell a dangerous drug that carries undisclosed risks of injury or death. As the Eight Circuit stated in the underlying case:
The generic defendants were not compelled to market metoclopramide. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product. Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sales. If Mensing’s injuries resulted from their failure to take steps to warn their customers sufficiently of the risks from taking their drugs, they may be held liable.
Mensing v. Wyeth, 588 F.3d 603, 611 (8th Cir. 2009). Simply put, no company is forced to sell a product it knows is unsafe. If they choose to do so, they should be held accountable, whether they are a name-brand manufacturer or a generic manufacturer. The U.S. Supreme Court’s decision ignored this important fact.
As a result of the high court’s misguided ruling, consumers whose prescriptions are filled with generic drugs lack the ability to sue the drug company for a failure to warn of known risks of their drugs while those whose prescriptions are filled with name brand drugs may pursue such a claim. As the majority opinion concedes:
We recognize that from the perspective of Mensing and Demahy, finding pre-emption here but not in Wyeth makes little sense. Had Mensing and Demahy taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits. We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated.
Pliva, Inc. v. Mensing, No. 09-993, 09-1039, 09-1501, 2011 U.S. LEXIS 4793 at *35 (2011). In her dissent, Justice Sotomayor, commented:
As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: This outcome “makes little sense.”
Id. at *39. She also noted that the court’s decision affected 75 percent of all prescription drugs dispensed in the U.S. given the dominant position of generic drugs.
The decision in Mensing is just one more example of a disturbing trend of U.S. Supreme Court decisions favoring big business and diluting the rights of consumers. According to the opinion, generic drug manufacturers sold approximately $66 billion worth of drugs in 2009. With such sales, and the enormous profits they generate, comes a responsibility to ensure that the prescription drugs used by millions of Americans every day are safe and are accompanied by warnings clearly identifying all known risks of the drug’s use. The Defendants in Mensing failed to live up to this important responsibility. As a result, Debra Mensing lost control of the muscles in her face, tongue, arms and legs, rendering her helpless and unable to speak. Because of the U.S. Supreme Court’s decision, the generic drug company that caused these horrific injuries can continue to sell dangerous and defective drugs without any fear of legal recourse.