The Supreme Court heard arguments Wednesday in a case that will determine whether a Slidell woman can sue a generic drug company that failed to warn her about the debilitating potential side effects of a drug she was taking for acid reflux.
At issue is whether federal law, which requires generic drugs to bear the same warning labels as their brand-name equivalents, effectively precludes generic manufacturers from taking steps that might have provided Julie Demahy with adequate warning that her extended use of the acid reflux drug metoclopramide could lead to her developing a severe and irreversible neurological disorder known as tardive dyskinesia.
The generic drug manufacturers — Actavis and Pliva — are asking the Supreme Court to find that Demahy and a similarly situated Minnesota woman, Gladys Mensing, should not be able to bring failure-to-warn claims against them in state court when those companies had met the letter of federal law.
But, Washington, D.C., attorney Louis Brogard argued that the generic companies can and should have provided information to the Food and Drug Administration about risks associated with the drug that went beyond what was on the label, and should have asked the FDA to require that the labels be changed on both the brand name drug and their generic equivalents.
Deputy Solicitor General Edwin Kneedler, representing the position of the U.S. government, also pleaded on behalf of Demahy’s right to sue, contending that the federal laws intended to promote generic drugs “do not absolve a manufacturer of his responsibilities after entry onto the market to maintain the safety of the drug and the adequacy of the label.”
In their questioning, the justices seemed, as usual, pretty evenly divided on the case, with Justice Sonia Sotomayor asking the most pointed questions of New York attorney Jay Lefkowitz, who pleaded the case on behalf of the manufacturers.
“Do you think Congress really intended to create a market in which consumers can only sue brand-name products?” asked Sotomayor. “Because if that’s the case, why would anyone ever take a generic?
“Why would Congress or the FDA intend to treat the two differently?” she asked.
“I understand that from the consumer’s point of view it may not make a lot of sense, but what Congress specifically said is that a generic has to bear the same label and it is because they do have different purposes, different functions,” replied Lefkowitz. “Congress said that whenever there is a brand drug on the market that no longer is protected by its patent monopoly, but has been selling for $10 or $20 a pill, we want to have generics selling for pennies for the pill, and they’ve given branded and generics different obligations,” Lefkowitz said.
Lefkowitz said the FDA decided that it should tell generics when to change their labels, “because we don’t assume the generics are going to know when the label should change because they don’t have the same basis of clinical testing and results.”
Justice Antonin Scalia, who would be expected to side with the generic companies in this case, carried that line of reasoning further, suggesting that the folks at these generic companies are, in essence, “this guy who graduated from high school.”
“This is a generic manufacturer, he doesn’t know anything about science,” said Scalia. “He knows how to replicate this pill exactly, that’s all he knows.”
Brian Glorioso, part of the Slidell legal team from the firm of Tonry, Brinson & Glorioso that brought the suit on behalf of Demahy, said that Scalia’s depiction was a gross mischaracterization of a generic drug industry that is huge and sophisticated and fully capable of tracking potential problems with the medications it produces.
Glorioso said there was nothing in the federal law that precluded Pliva and Actavis from knowing the hazards associated with long-term use of the generic equivalents of the brand-name drug Reglan, and with reporting those concerns to the FDA and seeking a label change.
“They had an obligation to trigger an FDA consideration of a stronger label,” said Glorioso
Glorioso was joined by attorneys Richard Tonry II and Kristine Sims of Demahy’s legal team in watching the arguments Wednesday.
Glorioso said afterward that they had texted Demahy to let her know how the arguments went, and that she was going to listen to a recording of them online with her son. They said she wanted to be there in person Wednesday, but her physical condition, particularly after a recent fall, didn’t permit it. Her attorneys said Demahy is now on a drug that costs $6,000 a month, and she must travel to Texas for treatment.
The highlight of the arguments for Sims was Sotomayor’s questions, which she said cut to the heart of the case.
“Sotomayor rocks,” Sims said.