The U.S. Solicitor General is asking the Supreme Court to refuse to grant an appeal to pharmaceutical companies that want to continue to sell generic versions of Reglan.
This case, which is known as the Mensing Decision, is in response to an appellate court ruling that made the manufacturers of generic Reglan (metoclopramide) liable and accountable for not warning the public properly of the risks of patients developing tardive dyskinesia. Naturally, the makers of generic Reglan want that liability judgment reversed and have filed an appeal of the decision.
Tardive dyskinesia is a rare movement disorder that has been linked to the drug. When the Supreme Court asked the U.S. Solicitor General to give its opinion on the matter of accountability of generic Reglan manufacturers, the Solicitor General expressed its support of the appellate court ruling in an amicus brief filed about two weeks ago.
“The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted,” the Solicitor General says. “A generic manufacturer can (and indeed, must) inform the FDA of new information about the risks that may require a change in the labeling of its drug.”
While it is highly doubtful that the manufacturers will succeed in their appeals, this case brings to mind the many pharmaceutical companies that are suffering from similar judgments against them. Many of these manufacturers of drugs like Reglan are trying to downplay the risks that their drugs pose to patients’ health and safety for the sake of higher sales. While it works for a time before trials and claims start to bring it all down to ashes, the trustworthiness of drug companies is falling ever more into doubt by the public and the FDA. The problem here is that by the time any of these companies is held liable for it, the damage to people’s lives has already been done.