By Allison Torres Burtka
The Supreme Court heard oral argument last week in a case that will decide whether a generic drug manufacturer has the same responsibility to warn of serious side effects that a brand-name manufacturer has. Plaintiff attorneys note that if the generic companies prevail, people who take generic drugs will be left without a remedy that is available to people who take brand-name drugs. (Pliva, Inc. v. Mensing, No. 09-993 (U.S. Mar. 30, 2011).)
Gladys Mensing and Julie Demahy allege that they developed the neurological disorder tardive dyskinesia from taking metoclopramide, the generic form of Reglan, to treat their stomach conditions (diabetic gastroparesis and gastroesophageal reflux) for years. They filed separate lawsuits against the manufacturers, alleging they were liable under state law for failing to warn that the drug could cause the disorder.
The generic drugmakers argued that those claims were preempted by the Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act, which require a generic label to match that of its associated brand-name drug. Because their labels had to match, the generic companies could not have strengthened them, they argued.
The Fifth and Eighth circuits held that the plaintiffs’ claims were not preempted, in line with the Supreme Court’s 2009 decision in Wyeth v. Levine regarding brand-name drugs. (129 S. Ct. 1187 (2009).) Every court since Levine, as well as the U.S. solicitor general, agreed. When the Court decided to take up the issue, it consolidated the women's lawsuits. (Demahy’s case is Actavis, Inc. v. Demahy.)
Louis Bograd, senior litigation counsel with the Center for Constitutional Litigation in Washington, D.C., argued the case for the plaintiffs. “The central issue in this case is that petitioners, in the face of considerable information that the warnings on their products were inadequate, did nothing,” he told the justices.
Jay Lefkowitz of New York City argued the case for the generic drugmakers. In reporting adverse events to the FDA, he said, “we have done everything we are required to do.” The companies were not obligated to ask for a label change, he said.
Justice Sonia Sotomayor asked Lefkowitz, “Counsel, do you think Congress really intended to create a market in which consumers can only sue brand-name products? Because if that’s the case, why would anybody ever take a [generic drug]?”
Lefkowitz said that “generics can’t simultaneously comply with a federal duty to be the same and a state duty to be different.” He added that “there is no state cause of action because this is a uniquely federal area, and states can’t supplant the FDA in its enforcement discretion.”
Bograd responded that even though “the ultimate decision about whether the labeling is changed rests with the FDA,” the manufacturer has a responsibility to initiate a labeling change when it has reasonable evidence that the current label is inadequate. The manufacturer would not be asking for its label to be different from that of the branded drug, he explained, but rather for the agency to approve a stronger warning for both.
The plaintiffs pointed out in their brief that 70 percent of all prescriptions in the United States are filled with generic drugs and that, of the drugs that have both a generic and a brand-name available, more than 90 percent of the prescriptions are filled with generics.
“If generic [drugmakers] are not responsible, in many of these cases no one is responsible,” Bograd said, noting that every state has a law to encourage generic prescriptions.
“Compiling the available medical literature on the adverse effects of metoclopramide, which would have alerted the generic manufacturers to the inadequacy of their label in this case, would have cost them a nominal amount,” said Michael Johnson, a Minneapolis lawyer who represents Mensing. “We think that’s a reasonable thing to ask of them,” he said.
The parties, the lower courts, and the solicitor general had disagreed about what procedures the companies could have used to strengthen their labels. But the particular process doesn’t really matter, Bograd said after the argument. “Even the generic drug companies concede that they could have picked up the phone and asked” the FDA for a label change, he said.
A long list of organizations submitted amicus briefs in support of the plaintiffs—leading Bograd to characterize the case as “the generic companies against the world.”
The American Medical Association and a group of seven other medical associations sided with the plaintiffs, arguing that “it should be the manifest public policy of this nation that all drug manufacturers—brand and generic—have a continuing duty to conduct themselves as vigilant, active, and responsible members of the health care community in furtherance of the safety and well-being of the American public.”
AAJ noted in its brief that the tug-of-war over preemption is “a concerted, targeted, and protracted effort on behalf of the pharmaceutical industry to promote their business interests, namely financial gain, while escaping liability and accountability for their tortious conduct.”
Rep. Henry Waxman (D-Cal.), who authored the Hatch-Waxman amendments, and the attorneys general of 42 states and the District of Columbia also submitted briefs on the plaintiffs’ behalf.
“If the Court sides with the plaintiffs, physicians and patients will receive adequate warnings about the prescriptions they take, and hundreds of thousands—if not millions—of injuries will be prevented,” Johnson said. The people who benefit “won’t know that they have Gladys Mensing and Julie Demahy to thank, but they will.”