Earlier this week, a Missouri appeals court issued an opinion that will hopefully have a significant impact on ongoing litigation against the manufacturers of metoclopramide, the generic version of Reglan. In this latest case, the appeals court found that plaintiffs Franzman and Niceley, both of whom suffered tardive dyskinesia after ingesting metoclopramide on a long-term basis, could proceed with their individual lawsuits against the generic drug manufacturer for negligence claims based on a failure to timely update the warning label for their drugs. This finding is based upon the generic drug manufacturer’s failure to comply with its legal duty to promptly update the generic drug’s warning label when the warnings for the brand name version are updated. This is one of several cases where state courts have rejected the defendants’ claims that generic drug manufacturer preemption under federal law immunizes them from all liability, even when the drug companies have failed to comply with their own legal obligations under state and federal law. The highest appellate courts in Iowa and Alabama have also recently issued opinions in favor of injured plaintiffs in Reglan cases, finding that the patients should be permitted to litigate some negligence claims against the generic drug manufacturers and those claims are not preempted by federal law. Dozens of federal courts have refused to hold the generic drug manufacturers liable under essentially identical facts involving patients with metoclopramide-induced tardive dyskinesia.
Reglan, also known as metoclopramide, was first marketed as a brand name drug in the early 1970s by Wyeth. The drug was approved for use short-term in patients with gastroparesis and other serious swallowing disorders. Reglan increases muscle contractions in the digestive tract, which helps to improve the speed at which the stomach empties into the intestines. Over the years, generic formulations came to market, and the brand name version of Reglan was rarely prescribed. As more generic drug companies sought sales for their formulations of Reglan, there was an aggressive marketing effort to expand using the drug. The generic manufacturers encouraged doctors and patients to use metoclopramide to treat Gastroesophageal Reflux Disease (GERD) or heartburn, chronic conditions that required treatment for a time far over the four-month time limit considered safe for Reglan.
This surge in sales, sadly, led to an epidemic of patients with tardive dyskinesia. Reglan is one of several drugs that cause tardive dyskinesia. Tardive dyskinesia (TD) is a movement disorder characterized by involuntary movements. The disease often affects the facial muscles with patients having uncontrollable grimacing, twitching, and chewing. The patient’s ability to walk, move, and take care of themselves can also be affected. Tardive dyskinesia is often initially misdiagnosed as Parkinson’s Disease. On February 26, 2009, the FDA issued a press release noting a further enhancement in the warning label for Reglan and warned physicians not to prescribe the drug for more than a few months, as the risks of serious neurological impairment outweighed the benefits of the drug to patients.
Under current federal law, Wyeth, as the brand name manufacturer, had an obligation to update the warning label for Reglan to reflect changing information regarding the risks associated with the medication and monitoring adverse event data reported by healthcare providers and injured patients. Generic drug manufacturers, under our current flawed drug safety laws, are required to merely copy the brand name label. Since Wyeth has not been actively selling Reglan for years, the drug label has not been updated as frequently as it should have been and the brand name manufacturer is not actively engaged in adverse event monitoring. Wyeth updated the warning label for Reglan in 2004 to reflect that the drug should not be prescribed for over 12 months, as studies have shown that the risk of developing tardive dyskinesia increases substantially when the drug is used long-term. Some generic drug manufacturers failed to follow federal and state laws and did not update their warning labels to reflect this vital safety information after the 2004 change to the warning label and package insert for brand name Reglan. Current state and federal laws will not generally hold the brand name manufacturer responsible for injuries caused by a generic formulation, although the brand name manufacturer has some control over minimizing potential harm to these patients through proper labeling of their products.
In the past, the manufacturers of generic Reglan and other drugs have enjoyed almost-complete immunity in light of the Bartlett and Mensing decisions from the United States Supreme Court and other federal court case law. Over the past few years, dozens of seriously injured plaintiffs have had their lawsuits for serious personal injuries caused by generic drugs kicked out of court. Several thousand adults and children who developed catastrophic neurological injuries caused by Reglan have been waiting for more than a year for decisions on pending appeals in the Pennsylvania state appellate courts where Pliva, Teva, Morton Grove, UDL Laboratories, and other generic manufacturers of Reglan have sought case dismissals. This unfortunate (and avoidable) development in our legal system has left a gaping hole, where significantly injured plaintiffs are being denied justice and have no legal recourse against the giant drug companies who are responsible for (and were in a position to prevent) their injuries.
While there have been some efforts to fix this injustice in Congress, many victims, especially those who were harmed by Reglan, have been largely left without recourse. Ultimately, the costs associated with this defective drug will be borne by we, as the patients require expensive medical care and long-term nursing care often covered by Medicare and Medicaid. The costs to our economy of defective drugs such as this could easily exceed hundreds of millions of dollars, and those companies who are profiting from the sale of these dangerous products are not shouldering the burden of these costs. If generic drug manufacturers will not be held liable for the harm they inflict on patients, then we should not be forced by our government and health insurers to ingest their generic pharmaceuticals.
Want to learn more about generic drug preemption? You can do so at the Take Justice Back web site, which includes the stories patients who have died or been severely harmed by generic drugs, such as Reglan and Darvocet, and have been left with no recourse in our court system. You can also help to fix this problem by signing the petitions available on the Take Justice Back web site (over 20,000 consumers have already done so). Also, please ask your members of
Congress to address this problem before more Americans are harmed. The Patient Safety and Drug Labeling Improvement Act (S. 2295 and H.R. 4384), introduced in 2012 but not enacted, would help to address this critical safety issue. The FDA is also considering changes to its guidelines which will help, but not completely eliminate, the injustices created by generic drug preemption. As indicated by the United States Supreme Court in the past, only Congress can fix this mess.