Products Liability
Reglan Tardive Dyskinesia
Reglan lawsuits alleged product liability, negligence, failure to warn, fraud and misrepresentation claims against Wyeth Pharmaceuticals and manufacturers of generic Reglan, known as metoclopramide.
What Is Reglan Used For?
Reglan and other generic metoclopramide are drugs used to treat short-term heartburn caused by gastroesophageal reflux disease (GERD). They are also used to speed up gastric emptying in diabetes patients. Because the drug is a dopamine antagonist, it increases lower esophageal sphincter pressure.
What is Tardive Dyskinesia?
Tardive dyskinesia is a severe and frequently irreversible neurological disorder with symptoms including involuntary grimacing, protrusion of the tongue, lip smacking, rapid eye blinking, and movement of the extremities. There is no treatment for this disorder.
This disabling condition is caused by long-term use (typically, over 12 weeks) of neuroleptic drugs, which are used to treat gastrointestinal and neurological disorders. The FDA has recently required manufacturers of Reglan and other metoclopramide to put a black box warning on the product, which is the most severe action the FDA can require.
Some Reglan-related injuries are not mass tort cases but medical malpractice. Negligent prescription of Reglan can cause a variety of injuries including gait instability and involuntary tongue thrusts and other symptoms related to tardive dyskinesia. Sometimes Reglan will solve the acid reflux problem, and doctors will keep it going in spite of the clear indications that these neurological symptoms are more likely to appear when on the drug for more than 12 weeks.
Who Makes Reglan and Generic Metoclopramide?
Reglan was first manufactured by A.H. Robins Company, Inc., which later sold it to Wyeth Pharmaceuticals. In 2001, Wyeth sold the rights and liabilities of the drug to Schwarz Pharma, Inc.
Generic metoclopramide is manufactured and distributed by numerous companies, including Teva McKesson Packaging, Rugby, Quality Care Products and URL Pharma.
What Is The Status of Reglan Litigation?
Ultimately, for reasons explained below, this litigation largely failed in spite of some evidence that Reglan manufacturers provided the FDA and physicians misleading information about the risks of using the drug, and minimized the chances of these permanent injuries.
In May 2009, Reglan drug injury lawyers petitioned the Judicial Panel on MultiDistrict Litigation (JPML) for consolidation and coordination of Reglan injury cases. This type of coordination, called MultiDistrict Litigation (MDL), allows the cases to be combined before one federal judge for the purpose of common discovery.
In a big blow to the plaintiffs, the JPML held a hearing on the Reglan cases on May 28, 2009, and decided that the cases were best litigated on an individual basis for now. Therefore, the cases will proceed on an individual basis, and will not be grouped for common pre-trial discovery.
In 2019, most of these cases have settled and few lawyers are seeking these cases. The lack of an MDL and the troubles suing generic manufacturers was fatal to this litigation.
- Tardive dyskinesia medical malpractice cases
- Really tough opinion for plaintiffs. The opinion confirmed that federal regulations that applied to generic drug manufacturers of drugs like metoclopramide preempted state law failure to warn lawsuits.
- 2013 Win for Plaintiffs