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Supreme Court

Supreme Court: Generic drug makers cannot be sued in state court for permanent damage caused by bad labeling

Thursday, July 21, 2011 by: Jonathan Benson, staff writer
Tags: Supreme Court, generic drugs, health news


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(NaturalNews) Federal officials appear to have once again sided with Big Pharma rather than the people they are supposed to represent. In a 5 - 4 ruling, the US Supreme Court has decreed that patients injured by improperly or inadequately labeled generic drugs cannot sue their makers in state court for damages. The decision marks yet another nail in the coffin of compromised consumer protection laws, which have morphed into drug company protection laws.

The ruling came after three separate lawsuits accused generic drug manufacturers of selling drugs that did not bear proper warning labels about severe side effects. Teva Pharmaceutical Industries Ltd., Mylan Inc., and Actavis Inc., are all subjects of the lawsuits, and all allegedly sold generic versions of the anti-heartburn drug metoclopramide (Reglan, Metozolv) that plaintiffs say caused them to suffer tardive dyskinesia, an often permanent neurological disorder.

The US Food and Drug Administration (FDA) decided in 2009 to require that its most severe black box warning be placed on metoclopramide, but this decision came many years after evidence first began to surface in the 1980s that long-term use of the drug could lead to devastating side effects. And because of discrepancies between labeling laws for the brand-name version of the drug and its generic counterpart, many generics ended up not receiving the upgraded label.

In trying to justify the ruling, Supreme Court Justice Clarence Thomas said that if generic drug manufacturers had changed their labels to comply with state law, they would have been in violation of federal law, thus making compliance impossible. But the ruling also appears to exempt generic drug manufacturers from responsibility for proper labeling. In this case, though, the plaintiffs can still redirect their efforts towards fighting the brand-name manufacturer, Wyeth / Pfizer.

"This ruling puts the responsibility back in the lap of brand name manufacturers. They've dragged their corporate heels for years on doing the right thing by taking what they knew about the illegal activities of the AH Robins Company to the FDA," said Michelle Schwartz, spokesman for the Reglan Metoclopramide Victims Organization, referring to Wyeth's predecessor that allegedly lied about the safety of the drug in order to get it approved in the first place.

Sources for this story include:

http://news.yahoo.com/s/afp/20110623/hl_afp/...

http://www.prnewswire.com/news-releases/cont...

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