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US Supreme Court Takes on Dangerous Drug Lawsuits Over Warnings on Generic Labels

December 31, 1969

The Supreme Court has agreed to take on two dangerous drug lawsuits that will determine whether a plaintiff can sue a generic drug manufacturer for not including a warning about a medication's potentially dangerous side effects on its label. The nation's highest court will hear an appeal from PLIVA Inc. and other drug makers.

One products liability lawsuit was originally filed by Gladys Mensing, who is suing Teva Pharmaceutical Industries Ltd., Mylan Inc., and Actavis Group. She took metoclopramide for a number of years because she was suffering from diabetic gastroparesis. Mensing claims that the medication caused her to develop tardive dyskinesia. She contends that none of the generic drug's manufacturers and distributors including a warned of this possible side effect on their labels.

A federal judge granted the defendants' requests to toss out Mensing's dangerous drug complaint. They claimed that per federal law, labels of generic drugs are required to contain the same information as their brand-name equivalents. Metoclopramide's brand equivalent is Reglan, which also did not come with a warning that a user might develop the serious neurological movement disorder. The 8th U.S. Circuit Court of Appeals overturned the judge's ruling, finding that rather than market and sell a drug with inadequate labeling, the defendants could have stopped selling the drug or proposed a change to the label. Last year, the FDA mandated that metoclopramide and Reglan must now come with a warning about tardive dyskinesia.

The issues in this appeal involve not only whether a generic drug maker can be sued for an inadequate label, but also whether the manufacturer can warn the public about the possible danger that isn't included on the label of the drug's brand equivalent or change/recommend that the drug's label be modified.

In the other products liability case, Julie Demahy is suing an Actavis unit. She claims inadequate warnings on the label failed to warn her that she could develop a severe nuerological disorder from using metoclopramide for a longer period of time.

Drug manufacturers can be held liable for a drug that causes serious injury or illness and/or fails to warn about potentially dangerous side effect. It is important to explore your legal options regarding filing an Orange County, California dangerous drug lawsuit.

Tardive Dyskinesia
This neurological disorder causes involuntary and repetitive movements to the limbs and lower face. Lip smacking, grimacing, rapid eye movements, chewing, and impaired finger movements. There is no known treatment for this disorder, which can last even after the patient has stopped taking metoclopramide.

Court To Decide Lawsuit Over Generic Drug Labels, NPR/AP, December 10, 2010

Generic-Drug Makers Get Hearing at U.S. High Court, Business Week, December 10, 2010


Related Web Resources:
US Food and Drug Administration

Reglan , Drugs.com

Metoclopramide, National Institute of Health