As the Supreme Court awaits word from the Obama administration regarding its position on generic drug manufacturers' claims that federal regulation of prescription drugs grants them immunity from lawsuits in state courts, a panel of judges from the Sixth Circuit Court of Appeals has submitted the question to the Food & Drug Administration (FDA), requesting a response no later than July 29th.
Corporations have long sought to limit their liability for their own misdeeds by arguing that federal regulation, whether by the Federal Trade Commission or the FDA, prevents consumers from holding them accountable in state courts. The issue, which would provide complete immunity to even the most reckless corporate actors, has come before the Supreme Court several times over the last few years, most recently in the landmark case Wyeth v. Levine.
In Wyeth, the Court ruled that federal regulation of prescription drug labels does not free manufacturers from the responsibility of ensuring that their labeling contains the most up-to-date safety information available. Now, several generic Reglan manufacturers are using similar preemption arguments in an effort to shirk responsibility for injuries caused by their products. If successful, they could achieve complete immunity for their entire industry.
On October 24, 2008, a federal district court in Kentucky dismissed Dennis Morris' claims that the generic manufacturers of Reglan, also known as metoclopramide, failed to warn him of the dangers posed by the drug, which resulted in his developing Tardive Dyskinesia (TD), a disabling movement disorder.
The district court, citing an earlier decision out of Minnesota, upheld the generic manufacturers' argument that they cannot change their label because of FDA requirements that "a generic label be 'the same as' the listed [name-brand] drug label". But last year, the Eighth Circuit overturned the Minnesota decision that had informed the Kentucky judge's opinion, writing that "far from prohibiting [generic manufacturers] from taking steps to warn their consumers of new safety hazards, federal law requires such action."
Now, the Sixth Circuit is considering an appeal of the 2008 Kentucky decision. In all this legal maneuvering, it's easy to forget that the lives of real people, and their ability to hold negligent corporations accountable is at stake. People like August Macaluso, who at only 57 can no longer work because of the severity of his TD. After taking generic Reglan (metoclopramide) for only three months, August began suffering violent shaking spells, incessant blinking, and slurred speech. Doctors fear his condition is permanent.
All drug manufacturers, whether name-brand or generic, must be responsible for the safety of their products. And when those products cause serious harm to patients, those victims must have the ability to seek legal redress. The Eighth Circuit, along with the Fifth Circuit in Demahy v. Actavis, has supported this view. Let us hope that the Sixth Circuit and the Obama administration do the same.