Reglan, or its generic equivalent, metoclopramide (MCP), is a drug used for patients with gastroesophageal reflux (GERD), heartburn, diabetic gastroparesis, the prevention of nausea and vomiting associated with chemotherapy or post-operatively, as well as aiding in various medical procedures.
It is important to follow the indication of “short-term use” (4 to 12 weeks), however, the medical conditions are all long-term problems. The reason why this is so critical is the risks of serious side effects increase significantly after 12 weeks of use. The Food and Drug Administration (FDA) has only approved Reglan for short-term use, but approximately 30 percent of Reglan patients are being prescribed the medication for 12 months or longer; long-term Reglan has been linked to Tardive Dyskinesia (TD). Tardive Dyskinesia is a horrible, debilitating condition, for which there is no cure. It affects its’ victims physically, mentally, emotionally, socially and permanently.
The risks associated with Reglan side effects increase the longer the medication is used. In February 2009, the FDA issued a warning regarding Reglan tardive dyskinesia, indicating that the use of the drug for longer than three months increased the risk for this condition. Unfortunately, the warning came too late for so many patients who had already filed Reglan lawsuits for their injuries.
While many Reglan side effects are temporary, some patients have experienced serious side effects including TD. This is characterized by repetitive, involuntary movements of the limbs accompanied by facial grimacing, rhythmic protrusion of the tongue, lip smacking, bulbar speech, rapid blinking of the eyes and tremors. Rapid movement of the arms, legs and trunk may occur. Movements of the fingers may appear as though the patient is playing “air guitar” or piano. In many cases, these symptoms are irreversible and there is no widely effective treatment at this time. Some metoclopramide side effects, such as Neuroleptic Malignant Syndrome, can be fatal, while others are permanent.
Another major issue is the prescribing of Reglan for off-label uses, meaning for conditions not approved by the FDA. These include treatment of pregnancy-related nausea and morning sickness, as well as treatment of migraine headaches with nausea. Some forms of Reglan, such as the injectable version, are approved to treat nausea caused by chemotherapy. However, there are other uses of oral Reglan, such as for radiation nausea. Also, Reglan is sometimes used to treat post-operative nausea, none of which are FDA approved. Off-label use of a drug is not illegal, but it is not recommended, as it has not been proven to be safe and/or effective.
Both the brand name drug, Reglan, and the generic form of Reglan, metoclopramide, may be involved in Reglan litigation.
Due to the inadequate labeling and warnings, the FDA issued an advisory requiring the addition of a Boxed Warning for Reglan/MCP in February 2009. The new warning tells doctors and patients, “Prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases.” Finally, the FDA is now requiring that all manufacturers implement a Risk Evaluation and Mitigation Strategy because they have determined that the use of Reglan/MCP “poses a serious and significant public health concern requiring the distribution of a Medication Guide.”
Many more cases have been filed across the country since the Boxed Warning was issued by the FDA. In anticipation of this increase in litigation, a motion was filed with the Judicial Panel on Multidistrict Litigation (MDL) for the formation of a federal MDL. Ultimately, the Federal Judicial Panel ruled against the formation of an MDL. Since then, coordinating courts have been established in state courts for Reglan litigation in: Philadelphia, Pennsylvania, Newark, New Jersey, and San Francisco, California. Numerous lawsuits against brand name and generic manufacturers are set to begin trial in the coming year in state and federal courts across the country and in the state court consolidation in Philadelphia.
Last year, a Supreme Court ruling prohibited injured patients from filing Reglan lawsuits against manufacturers of the generic form of the drug.
Patients taking the generic form of Reglan, metoclopramide, currently have few options when it comes to litigation. Those who filed Reglan lawsuits against generic manufacturers last year ended up with nothing, as the courts ruled that generics cannot be held liable as long as their product labels match exactly to those of the brand-name drug. In fact, even if a generic manufacturer wanted to update their labels to list new information or warnings regarding side effects, they would be unable to under the current laws.
On April 18, 2012, the “Patient Safety and Generic Labeling Improvement Act” was introduced, which allows generic drug manufacturers to change their drug labels and provide up-to-date warnings to doctors and to the public. It is not fair that if a consumer takes a brand-name version of the drug they can sue the manufacturer for inadequate warnings, but if the pharmacy inadvertently gives them the generic version, they would not be able to seek compensation for their injuries. The generic companies oppose the act, claiming confusion on the patient’s part regarding different warnings from different drug companies. The consumer advocacy group Public Citizen has asked the FDA to take similar action to allow generics to make label changes, but, so far, the agency has said that it needs more time to decide on the issue.
For more information regarding the status of Reglan litigation, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).