The Pennsylvania Supreme Court shot down generic Reglan manufacturers and the maker of Reglan’s request to flip the trial court’s decision to deny their preemption summary judgment motion.
Reglan is used to treat short-term heartburn caused by gastroesophageal reflux disease (GERD). It is also used to speed up gastric emptying in diabetes patients. Because the drug is a dopamine antagonist, it increases lower esophageal sphincter pressure.
The problem with Reglan – plaintiffs allege – is that it causes tardive dyskinesia, an often irreversible and just plain awful neurological disorder with symptoms that include involuntary grimacing, protrusion of the tongue, lip-smacking, rapid eye blinking, and movement of the extremities. There is no treatment for this disorder.
Anyway, the trial court denied the defendants’ motion for summary judgment because the defendants did not show that the law would recognize none of the causes of action asserted by the plaintiffs.
I don’t think this means all or even any Reglan cases will make it past preemption. I think it means that it is still too soon to call what effect preemption will have on these claims.
What Is the Issue With Preemption?
Preemption is a legal doctrine that says federal law can override state law, and it was used by the defendants in Reglan cases to argue that the plaintiffs’ claims were preempted by federal law.
In particular, the defendants argued that because the U.S. Food and Drug Administration (FDA) had approved Reglan as safe and effective, the plaintiffs’ claims were preempted by federal law. The defendants claimed that the FDA’s approval of the drug meant that they were protected from liability for any harm caused by the drug.
However, the plaintiffs argued that the defendants had failed to provide adequate warnings about the risks of Reglan and that this failure to warn constituted a violation of state law. They also argued that federal law did not preempt their claims.
History of Reglan Lawsuit
Reglan is a brand name for metoclopramide, a medication that is used to treat gastrointestinal disorders such as gastroesophageal reflux disease (GERD) and gastroparesis. It works by increasing muscle contractions in the digestive system.
Reglan Linked to Tardive Dyskinesia
In the 1980s, reports emerged linking metoclopramide to a condition known as tardive dyskinesia, which is a neurological disorder that causes involuntary movements, often in the face and mouth. Tardive dyskinesia can also cause uncontrollable tics and grimacing. The condition is caused by long-term use of medications that affect the levels of the neurotransmitter dopamine in the brain, including Reglan. In 1985, the US Food and Drug Administration (FDA) issued a warning about the risk of tardive dyskinesia associated with the long-term use of metoclopramide.
Despite the warning, the drug continued to be prescribed for long-term use. And, not surprisingly, patients kept developing tardive dyskinesia. Lawsuits began to be filed against the manufacturers of Reglan, including Wyeth (now a subsidiary of Pfizer), alleging that they had failed to adequately warn doctors and patients about the risks associated with the drug.
Black Box Warning
In 2011, the FDA issued a black box warning for metoclopramide, the strongest warning the agency can issue, which highlighted the risk of tardive dyskinesia and warned against long-term use of the drug. The warning also advised that the drug should be used at the lowest effective dose for the shortest possible duration.
Reglan Class Action Lawsuit
A Reglan class action lawsuit was created in 2010 in the United States District Court for the Southern District of Alabama. The purpose of the MDL class action was to consolidate the federal lawsuits that had been filed against the manufacturers of Reglan.
The lawsuits alleged that the manufacturers of Reglan failed to adequately warn doctors and patients about the risk of developing tardive dyskinesia. The lawsuits claimed that the manufacturers of Reglan knew or should have known about the risk of developing tardive dyskinesia and failed to adequately warn patients and doctors. The lawsuit did not say why but the undercurrent was clearly that there were more sales and profits without a warning.
hundreds of lawsuits had been filed against the manufacturers of Reglan, and several large settlements had been reached. In some cases, juries had awarded plaintiffs significant damages in trials against the manufacturers.
The Reglan MDL included hundreds of individual lawsuits from across the United States. The lawsuits were consolidated for pre-trial proceedings, such as discovery and motions, before being sent back to their respective courts for trial. In 2015, the MDL was closed, with most of the cases either settled or dismissed. Cases that opted out of the MDL went to trial and there were so big plaintiffs’ victories.