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J&J Loses Jury Trial on Warnings of Levaquin Risk

Johnson & Johnson failed to properly warn of the risks of tendon damage linked to its antibiotic Levaquin, a Minnesota jury said in the first trial on claims over the drug.

The Minneapolis federal court jury today awarded damages of $700,000 in the case of John Schedin, 82, for failure to warn. It rejected his claim that J&J violated state consumer-fraud law by misrepresenting or concealing information about Levaquin. Jurors are considering Schedin’s claim for punitive damages.

Schedin in 2008 sued J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit, claiming he ruptured both Achilles tendons after taking the drug. The companies didn’t warn doctors and patients of Levaquin’s association with tendon damage, he said.

The trial is the first on more than 2,600 claims in U.S. courts alleging that Levaquin caused tendon damage in patients and that New Brunswick, New Jersey-based J&J failed to disclose the risk adequately.

The jury assigned 75 percent of liability to Ortho-McNeil-Janssen, 10 percent to Schedin and 15 percent to his doctor, who isn’t part of the lawsuit. This will reduce the judgment so far against Ortho to $630,000, Jake Sargent, a company spokesman, said today in an interview.

The company will issue a statement when the trial is over, Michael Heinley, a spokesman, said in an e-mail.

FDA-Ordered Warnings

In 2008, the U.S. Food and Drug Administration required J&J and makers of related drugs in the class of antibiotics called fluoroquinolones to include warnings on the risk of tendon ruptures. The risk was higher in patients older than 60, those taking steroids and recipients of kidney, heart or lung transplants, the FDA said.

The plaintiffs claim the label warning should have been improved earlier and remains inadequate. They also say J&J and Ortho-McNeil-Janssen boosted sales by downplaying risks.

“They obfuscated and manipulated the truth for profit,” Mikal Watts, Schedin’s lawyer, said Dec. 6 in his closing arguments in the trial. “It was a one-drug franchise that was crucial to the health of this company.”

The drug has been prescribed more than 430 million times worldwide, company lawyers said in a court filing last month. Its sales for the previous nine months were $957 million.

J&J and Ortho denied any concealment of information or that Schedin’s injury was linked to Levaquin use.

“There is no proof that Levaquin caused Mr. Schedin’s tendon rupture,” John Dames, J&J’s attorney, said in closing arguments Dec. 6.

Punitive Damages

Schedin is seeking punitive damages, claiming that Ortho-McNeil acted with deliberate disregard for safety.

“In fact, the company acted in a way that was not deliberate disregard,” J&J attorney Tracy Van Steenburgh told the jury today in the punitive phase of the trial. “This case is about whether this company provided enough information.”

Ortho-McNeil didn’t send doctors letters about Levaquin’s risks before the 2008 label change, Watts said today.

“If they had made that choice, it would have helped educate doctors,” driving down the rate of tendon problems, he said.

Schedin was prescribed Levaquin and a steroid for an upper respiratory infection in 2005, according to his complaint.

“Prior to his Levaquin-induced bilateral Achilles tendon rupture, he was vigorous and active for his age,” his lawyers said in a Nov. 14 filing. “He has never fully recovered and is now severely restricted in his activities.”

His doctor would have prescribed another antibiotic had he known “about the risks associated with Levaquin, especially when taken together with steroids,” Schedin said in court papers.

The case is Schedin v. Johnson & Johnson, 08-cv-05743, combined for trial in In re Levaquin Products Liability Litigation, 08-md-01943, U.S. District Court, District of Minnesota (Minneapolis).

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