Reglan Lawsuit Turns Into Supreme Court Case

In a situation almost unheard of in personal injury cases, a recent Reglan lawsuit is being heard by the United States Supreme Court and could make drastic changes to laws surrounding the pharmaceutical industry. Pliva Inc. v. Mensing is being heard by the court after a woman began experiencing serious side effects associated with a generic version of the gastrointestinal drug Reglan.
The plaintiff, Gladys Mensing, began taking Reglan in 2001 to treat heartburn and acid reflux, but after four years of using the drug developed Reglan-related tardive dyskinesia, which has been linked to Reglan (generic name metoclopramide). The risk for the condition was well established, and both the makers of brand name Reglan and generic forms of metoclopramide had a responsibility to patients to warn them of potential risks.

A black box warning was placed on Reglan and its generic forms in 2009 by the Food and Drug Administration. This warning detailed the relatively high risk of tardive dyskinesia and other neurological movement disorders associated with metoclopramide. However, for many patients, this warning came too late. There is no cure for tardive dyskinesia, and once symptoms manifest those symptoms will likely stick with the patient for the rest of his or her life.

The case has reached the Supreme Court because the generic drugmakers who manufactured Reglan-like drugs had a responsibility to warn consumers of the potential risks, but federal law mandates that generic drugmakers must use labels that state the same warnings as on the brand name of the drug and are approved by the Food and Drug Administration. Therefore, if brand name Reglan did not have appropriate warnings, the defense argues, generic Reglan was unable to place proper warnings on their packaging because it was prevented by federal law.

Since generic products make up about 70 percent of all prescriptions filled in the United States, this is an important court decision that will decide whether or not generic medications are responsible in these situations.