In a setback for patients affected by the gastro esophageal reflux disease medication Reglan, a federal court rules that Wyeth and Schwarz Pharma are not responsible for injuries suffered by taking a generic formulation of the drug.
Specific details are sparse, as the primary source for the announcement is the FDA, which charges a fee for access to full information. However, the basic judgment in the Texas case is that since the plaintiff took a generic version of the drug, the brand manufacturers are not responsible for the injuries that resulted.
The decision does leave open the option to bring a case against the specific manufacturer of the generic version, but ignores the potential responsibility of the original manufacturers who promoted the product despite its dangers.
Generic medications result when the patents on a particular medicine expire, allowing competitors to manufacture their own version in an attempt to cash in on a market established by the originators of the treatment. If a potentially harmful medicine such as Reglan survives legal challenges long enough for the patent to expire, then the chances of it harming others go up drastically as it becomes much more widely available.
Reglan has been linked to a serious medical condition known as Tardive dyskinesia. The disorder is characterized by a number of symptoms which are commonly not reversible. These are movement-based symptoms, such as uncontrollable movement in the arms, facial muscles, lips, legs, torso, hips and other parts of the body. Fingers often will twitch uncontrollably, disrupting fine motor control. Sleeping is difficult enough on some nights, and can be all but impossible when your body insists on moving constantly, without any control you can provide.
While details will still be emerging over the following days, limiting the liability of the manufacturer takes a significant tool out of potential lawsuits in the future, and sets a precedent that other judges might observe.