MINNEAPOLIS (AP) – A federal court jury on Wednesday ordered health care company Johnson & Johnson to pay damages of $1.8 million in the case of an 82-year-old Minnesota man who sued over claims the antibiotic Levaquin caused him severe tendon injuries.
John Schedin of Edina was prescribed Levaquin five years ago to treat a diagnosed case of bronchitis. After three days on the drug, Schedin ruptured both his Achilles tendons. In 2008, the Food and Drug Administration required Johnson & Johnson and makers of similar drugs to print warnings on the risks of tendon injuries.
That same year, Schedin sued Ortho-McNeil-Jansen Pharmaceuticals, the unit of New Brunswick, N.J.-based J&J that markets Levaquin. The Minneapolis jury on Wednesday decided the company must pay Schedin $700,000 in actual damages and $1.1 million in punitive damages, though actual damages will be reduced by $70,000 under the jury’s finding of 10 percent liability for Schedin in response to the allegation that he exacerbated the condition by initially responding to his tendon pain by exercising.
The trial was the first on more than 2,600 other U.S. lawsuits making similar claims. Schedin’s attorney Mikal Watts called the trial a bellwether case that he expected would hasten settlement talks in those suits.
“Johnson & Johnson failed to warn these doctors of something they knew would hurt these patients and that’s conduct that should not be tolerated,” Watts said. “The award of punitive damages in particular sends a powerful message.”
Michael Heinley, spokesman for Ortho-McNeil-Janssen Pharmaceuticals, said the company was disappointed with the jury’s decision and plans to fight the plaintiff’s claims on appeal.
“The verdict and the amount of the compensatory and punitive damages are at odds with the evidence presented at trial,” Heinley said in a prepared statement. “We believe Ortho-McNeil-Janssen Pharmaceuticals Inc. properly informed of the benefits and risks associated with the use of Levaquin, and that the company acted responsibly by providing appropriate and timely information about Levaquin.”
Watts said that Schedin has never fully recovered from his tendon injuries – that he can no longer walk long distances and must crawl to get up steps in his home. During the trial, the plaintiffs claimed that warning labels should have been improved earlier than they were, and that those on labeling now remain inadequate.
In a court filing, Schedin said his doctor would have prescribed something other than Levaquin if he had known of the risks of Levaquin, particularly in conjunction with steroids – which he also prescribed to treat Schedin’s bronchitis.
The 2008 FDA order compelled Johnson & Johnson and other makers of antibiotics in the class known as fluoroquinolones to note the risk of tendon ruptures, which was found to be higher in patients older than 60, organ transplant recipients and steroid users, according to the agency.
Plaintiffs argued that the pharmaceutical company played down those risks out of fear it would hurt sales of Levaquin. In court documents, the company stated the drug has tallied up annual sales approaching $1 billion and by 2006 had become the most-prescribed antibiotic in the world.
Date: December 8, 2010
Source: Associated Press