As a U.S. Supreme Court generic Reglan lawsuit case has finally seen the inside of a courtroom, many people are expecting the ruling will change the entire way that pharmaceutical companies and generic drug manufacturers do business in the future. While the Supreme Justices aren’t expected to make a ruling in the consolidated Mensing v. Pliva case until June, some of them are speaking out already.
The 9 judges on the Supreme Court Panel each seem to have different opinions when it comes to the liability of generic drug makers in warning the public about Reglan’s side effects like Tardive Dyskinesia. While federal laws don’t require generic drug makers to list warnings on their labels, state laws do. This is the main argument in the Reglan lawsuit, and the debate continues outside of the courtroom.
Justice Antonin Scalia has said, “I don’t see how you can hold them [generic drug companies] liable. The argument here is whether it will be the FDA ultimately that determines whether there was a grave enough risk to modify the label or whether that call will be made by a state court guessing what the FDA would have done, right?”
However, Justice Stephen Breyer showed himself to be on the other side of the fence when he addressed the defendant’s lawyers and said, “So your argument is that if we run across this tremendous… really serious problem, you’re saying the state has no right to say — even if we purposely didn’t tell anybody — they can’t get involved?”
While Justice Sonia Sotomayor sides with the plaintiffs, she also brings up the issue of generic vs. brand-name medications, saying, “Do you think Congress really intended to create a market in which consumers can only sue brand-named products?”
Justice Samuel Alito mostly gave his opinion about what a ruling for the plaintiff would mean. He asked, “Has the FDA made any calculation of the economic consequences of imposing this duty on generic drug manufacturers? I don’t know whether this is a good idea or not, 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.”
The plaintiff’s lawsuit is also favored by the AMA, the Obama Administration and 42 states.
