Posted Mar 31, 2011 02:07 pm CDT
A lawyer for a woman who developed a neurological disorder while taking a generic drug says the highlight of oral arguments on Wednesday was questioning by Justice Sonia Sotomayor.
“Sotomayor rocks,” said Kristine Sims in an interview with the New Orleans Times-Picayune. Sims represents Julie Demahy of Slidell, La., who alleges her generic medication for stomach disorders caused tardive dyskinesia, a neurological disease that impairs motor control. Sims didn’t argue the case, but she was there to watch the arguments.
At issue in the consolidated cases before the U.S. Supreme Court is whether generic drug makers can be sued for failing to warn of side effects, according to stories by the Times-Picayune, the New York Times, Bloomberg and the Associated Press.
The Supreme Court ruled two years ago in Wyeth v. Levin that makers of brand-name drugs can be sued for failure to warn. The decision was largely based on the companies’ ability to change their drug labels without federal permission, the Times explains. Generic drug companies, on the other hand, are not permitted to change their labels; federal regulations require them to carry the same warnings as their brand-name counterparts.
Justices appeared nearly evenly divided during the arguments, according to the accounts by AP and Bloomberg. Sotomayor said she doubted Congress intended a two-track system for generic and brand-name drugs. “Do you think Congress really intended to create a market in which consumers can only sue brand-named products?” she asked. “Because if that’s the case, why would anybody ever take” a generic medicine?
The cases are Pliva v. Mensing, Actavis Elizabeth v. Mensing, and Actavis v. Demahy.