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Pliva v. Mensing And Developing Tardive Dyskinesia

Posted on behalf of Goldberg Finnegan, LLC on Jun 24, 2011 in Drug Litigation

WARNING: IF YOU CHOOSE TO TAKE A GENERIC DRUG OVER A BRAND NAME OF THE SAME DRUG YOU NOW MUST RELINQUISH YOUR RIGHT TO SUE THE DRUG MANUFACTURER FOR FAILING TO WARN OF KNOWN DANGERS.

Once again the United States Supreme Court has sided with the powerful pharmaceutical industry-this time manufacturers of generic drugs-- at the expense of just about everyone else--consumers who choose to take less expensive generic drugs instead of the brand name drugs. About 75% of prescription drugs sold in the USA are generic brands. So basically the rich, who may be able to afford the "brand name drugs", retain their right to sue but just about everyone else has now been stripped away of our right to sue and hold drug manufacturers accountable.

Four Supreme Court Justices dissented from this opinion explaining that "Today's decision leads to so many absurd consequences that I cannot fathom that Congress would have intended to preempt state law in these cases" ...."As a result of today's decision whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug."

The U.S. Supreme Court Decision, Pliva v. Mensing, essentially holds that Generic Drug Companies do not have to provide warnings to consumers/patients who take the Generic Drugs.

In this case, the manufacturer of Metoclopramide (brand name is Reglan), a dangerous drug used to treat acid reflux and speed the movement of food through the digestive system, did not have to warn consumers that the Reglan causes Tardive Dyskinesia even though the generic drug makers knew that long term use of Reglan carried a high risk of Tardive Dyskinesia.

The generic drug labels did not adequately warn of this risk. State Law would have required the generic drug companies to warn of this known risk. The Supreme Court Opinion written by Justice Clarence Thomas adopted a perverted analysis of the preemption doctrine and held that since the FDA had previously approved a label for the brand name drug Reglan, the generic manufacturers did not have a separate tort duty to warn of the newly discovered dangers of Reglan/Metoclopramide because the FDA had approved a warning label for Reglan in 1980. The Court found that the "impossibility preemption" doctrine applied even though it was conceded that it was not impossible for the generic manufacturers to comply with federal and state law.

The decision is significant because about 75% of all prescription drugs filled in the USA are generic brands. Generic Drug Sales in the USA is a $66 Billion Dollar Industry.

The takeaway? Before you agree to accept a generic drug instead of a brand name make sure you know that you are likely giving up your right to sue the drug manufacturer as a result of their failure to warn of known dangers.

In this case the generic drug manufacturer knew that 29% of those who took the drug would develop Tardive Dyskinesia. Yet this $29 Billion Dollar Industry was given a fee pass and the Supreme Court has chosen to put the cost of this risk on the individual generic drug consumer rather than on the drug companies.

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