Is There A Way Around The Supreme Court’s Generic Drug Ruling?

A Supreme Court ruling in June 2011 ended state-law claims against generic drug manufacturers  (link to previous article) because the drug manufacturers are obligated by federal law to provide drug labeling that is identical to the drug’s brand-name counterpart.  However, there seems to be a way around this ruling, which is being used by some plaintiffs who have been harmed by taking generic brand drugs.

In a recent federal court case, Cooper v. Wyeth, plaintiffs claimed that the manufacturers of the generic drug, metoclopramide (an acid reflux medication), failed to update the warning label, in a timely manner, to match its brand-name drug, Reglan.  As such, the claims against the manufacturer were recognized as valid arguments in federal court. This “failure-to-update” claim has been used in other federal court cases (Fisher v. Pelstring and Couick v. Wyeth) with positive results for plaintiffs.

It is federal law that generic drug labels match their brand-name equivalent.  Failure to update the labels timely, and in accordance with the FDA-approved changes for the branded label, would give some legal recourse to consumers who may have had an adverse reaction to a generic-brand drug.

Whether the courts will continue to recognize “failure-to-update” claims remains to be seen, but for now, there seems to be a legal avenue for damages for those who have been harmed by taking a generic drug.

Source: http://www.pagingdrblog.com/2012/03/28/is-there-a-way-around-the-supreme-courts-generic-drug-ruling/

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