May 24, 2024

Justices Hear Arguments in Generic-Drug Lawsuit

On Wednesday, the justices heard arguments in a follow-up case that presented an interesting wrinkle: May the makers of generic drugs, whose products must use the same warning labels as the corresponding brand-name drugs and who cannot alter those labels, also be sued for failing to warn users about the risks posed by their products?

The answer to the question will have enormous financial consequences, said Jay P. Lefkowitz, a lawyer for the drug companies. “This would totally change the way generics do business,” he said of a ruling against his clients.

The three consolidated cases the court heard on Wednesday, including Pliva Inc. v. Mensing, No. 09-993, were brought by women who took the generic equivalent of Reglan for stomach ailments and developed a serious neurological disorder. Appeals courts ruled against the drug makers, saying that the federal regulatory regime did not block claims under state law.

Mr. Lefkowitz said the rulings put his clients in an impossible position.

“Generics can’t simultaneously comply with a federal duty to be the same and a state duty to be different,” he said.

He said the makers of generic drugs are in a fundamentally different business from the companies that created the original medications.

“Brand companies do safety and efficacy testing; generics do sameness testing,” Mr. Lefkowitz said. “Generics are required to make copies of the drugs and by definition make copies of the labels, because it wouldn’t make any sense to go into a drugstore to buy Advil and to see 15 different generic ibuprofen and to have 15 different sets of warnings.”

Justice Antonin Scalia echoed that point, likening the makers of generic drugs to “this guy who graduated from high school.”

“He doesn’t know anything about science,” Justice Scalia said. “He knows how to replicate this pill exactly. That’s all he really knows.”

But a lawyer for the plaintiffs, Louis M. Bograd, said that it would be odd to hold the two kinds of companies to different standards.

“The position that the generics are proposing here is one in which they would be immune from liability for selling a product with inadequate warnings,” he said, “even though the name-brand company selling the same drug with the same warnings would be liable.”

Mr. Bograd added that 70 percent of prescriptions were filled with generic drugs and that a third of generic drugs had no brand-name competitors.

“If generics are not responsible,” he said, “in many of these cases no one is responsible.”

Several justices said makers of generic drugs could take steps short of changing their labels, including urging the F.D.A to take action.

“You could propose a revision of the label, and if you did that, then you would be home free,” Justice Ruth Bader Ginsburg told Mr. Lefkowitz. “You would not be subject to the state suit.”

But Justice Samuel A. Alito Jr. seemed skeptical of lawsuits based on what he called “a duty to lobby the F.D.A.”

Justice Sonia Sotomayor said she doubted that Congress had intended a two-track system.

“Do you think Congress really intended to create a market in which consumers can only sue brand-named products?” she asked Mr. Lefkowitz. “Because if that’s the case, why would anybody ever take” a generic medicine?

Later in the arguments, Justice Alito proposed an answer to that question.

“I don’t know whether this is a good idea or not,” he said of allowing state suits, “but it does seem to me that it may significantly increase the costs for generic drug manufacturers, and therefore counteract one of the objectives of the statute, which was to provide generic drugs at a low cost.”

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