June 24, 2013

Court rules generic-drug makers can’t be sued over defects

The ruling creates a legal oddity in which people who are hurt by a brand-name drug can sue the drug maker for damages, but the same is not true for those who take a generic drug.

By David G. Savage / Tribune Washington Bureau

WASHINGTON — Americans who are badly hurt by a generic drug may not sue the drug maker for compensation, the Supreme Court ruled Monday, giving manufacturers a shield from liability for the medications taken most commonly in this country.

The 5-4 decision tossed out a $21 million jury verdict in favor of a New Hampshire woman who suffered horrible skin burning over most of her body and was nearly blinded after taking a pill to relieve shoulder pain.

The court majority said the federal Food and Drug Administration had approved this drug for sale and that federal approval trumps a state’s consumer-protection laws.

In the case decided Monday, Karen Bartlett, the woman who suffered the severe reaction to sulindac, sued Mutual Pharmaceuticals, and a jury decided the pain pill was unreasonably dangerous.

The company appealed, arguing that the verdict conflicted with federal law.

Bartlett’s “situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment (in her favor) be reversed,” Justice Samuel A. Alito Jr. wrote for the court majority. Chief Justice John G. Roberts Jr. and Justices Antonin Scalia, Anthony M. Kennedy and Clarence Thomas agreed.

Dissenting, Justice Sonia Sotomayor said that “the court has left a seriously injured consumer without any remedy despite Congress’ explicit efforts to preserve state common-law liability.”

The ruling creates an oddity in the law. People who are hurt by a brand-name drug can sue the drug maker for damages, the Supreme Court said in 2009.

But the same is not true for those who take a generic drug. The court has now handed down two rulings that have closed the door to lawsuits from people injured by a generic drug.

About 80 percent of prescriptions written in this country are for generic drugs.

Bartlett took sulindac, a non-steroidal anti-inflammatory drug, at the direction of her doctor, and she had a rare, but severe reaction. The skin on nearly two-thirds of her body burned away. She spent more than two months in the burn unit of a Boston hospital, and she was left with permanent injuries.

Bartlett’s lawyers argued that sulindac was more likely than other similar pain relievers to cause the severe reaction that Bartlett suffered, known as toxic epidermal necrolysis.

The company responded that the FDA had approved Clinoril, the brand-name drug, as safe and effective, and that the generic maker was selling a version of the same drug.
 

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