The 6th Circuit in Smith v. Wyeth rejected last week the three Reglan lawsuits that sought to end run the U.S. Supreme Court’s recent generic drug preemption Pliva v. Mensing, a case so depressing I never blogged about it.
These three Reglan cases were classic failure to warn claims. Plaintiffs were taking generic Reglan to treat gastroesophageal reflux disease. Because Reglan’s patent expired, it was now generically available (and cheaper). Plaintiffs all developed tardive dyskinesia, a neurological disorder with Parkinson’s disease-like symptoms. Something awful to get for any reason but particularly for this one: had there been an adequate warning on the drug, these plaintiffs, at least arguably, would not have taken them.
Plaintiffs sued, among others, including the manufacturer of Reglan itself, the generic manufacturers for the failure to warn of the risk of tardive dyskinesia. Keep in mind, this is not saying that the product should be recalled. Instead, it just says, “Hey, you know the risks of Reglan and you should have told us about it (and we wouldn’t have taken it).”
The crux of plaintiffs’ lawyers’ argument against Reglan’s manufacturer is that the drug maker is liable because they know how it works and they know that that doctors and patients will rely on the name-brand warning when prescribing generic drugs. This claim, as I’m sure even plaintiffs’ lawyers expected – failed. Only one court – a California Court of Appeals decision three years ago – has ever gone the other way. The Court’s analysis was obvious: they didn’t make the product. Of course, the generics claimed they relied on Reglan’s warning.
No one takes responsibility for communicating a meaningful message to doctors and patients by using a defense that goes back to Adam and Eve: everyone is to blame but me. The name brand points to the generic who points back to the name brand.
Incredibly, this preposterous tactic works under the court’s interpretation of where the Supreme Court is (5-4, by the way, elections sure do count) on preemption. The court found that federal law immunizes generic drug makers from failure-to-warn claims because the maker of generics cannot unilaterally change their labels. So, basically, a generic drug maker can see the risk associated with the drug as clear as day but is not required to say the word “boo” about it. It is crazy. Unfortunately, only 44% of the United States Supreme Court agrees with me.
This case is another blow for failure to warn claims against generic drug manufacturers.