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U.S. Supreme Court Rules Generic Drug Makers Can’t Be Sued for Design Defects Under State Law, Rottenstein Law Group LLP Reports
Date:6/24/2013

(PRWEB) June 24, 2013

On June 24 the U.S. Supreme Court ruled 5-4 that makers of generic drugs can’t be held liable under state laws for the design defects of the drugs they manufacture. The Rottenstein Law Group LLP, which represents clients in drug injury lawsuits, is disappointed with the ruling, but emphasizes that this ruling does not affect those who believe they were injured by their brand-name drugs.

In its ruling in Mutual Pharmaceutical Co., Inc. v Bartlett,* the Court said that federal law and regulations preempt the state-law design-defect claim of victim Karen Bartlett, who alleged that she developed disfigurements related to toxic epidermal necrolysis (TEN) after taking sulindac, the generic form of the drug Clinoril she was prescribed in 2004. Sulindac manufacturer Mutual, as with other generic drug makers, is required by law to make generic drugs the same as their brand-name counterparts and to maintain the same warning labels. In this instance, Mutual did not include a warning about TEN on the sulindac label because the original drug’s label did not have the warning. It was not until 2005 that the U.S. Food and Drug Administration recommended changing all labeling for sulindac-type drugs to reflect the TEN risk.

“This is certainly not the ruling we would have hoped for,” said Rochelle Rottenstein, principal of the Rottenstein Law Group LLP. “But anyone who believes he or she has been harmed by a medication should speak to a lawyer to determine whether there is a viable claim to be made.”

Bartlett had originally sued Mutual in New Hampshire state court, but Mutual removed the case to federal court, according to the ruling. The federal jury awarded Bartlett $21 million, which was affirmed in the appeals court. The Supreme Court was the next court to consider the case.

The Rottenstein Law Grou
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