J&J Loses First Trial on Warnings of Levaquin Risk

Johnson & Johnson must pay $1.1 million in punitive damages to an 82-year-old man who claimed it failed to properly warn of the risks of tendon damage linked to its antibiotic Levaquin, a Minnesota jury said.

The federal court jury in Minneapolis today also awarded compensatory damages of $700,000 in the case of John Schedin, who sued J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit in 2008. Schedin, who said he ruptured both Achilles tendons after taking Levaquin, claimed the companies failed to warn doctors and patients of the drug’s association with tendon damage.

The trial was 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 today, in ordering punitive damages, found the company acted with deliberate disregard for the safety of others.

“We talked a lot about the responsibility the company had to the general public, as far as safety goes,” Zach Rawson, a juror from Rochester, Minnesota, said after the trial. “ We felt that they didn’t warn adequately, that they didn’t use enough means of warning the public, especially the doctors.”

Ortho-McNeil-Janssen will appeal, said Michael Heinley, a company spokesman.

“The verdict and the amount of the compensatory and punitive damages are at odds with the evidence presented at trial,” Heinley said in an e-mailed statement.

‘Properly Informed’

“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,” he said.

The jury’s $700,000 award of actual damages will be reduced to $630,000 on its finding that Schedin was 10 percent liable for the injury, Heinley said. The jury rejected Schedin’s claim that Ortho-McNeil-Janssen violated Minnesota’s consumer fraud law by misrepresenting or concealing information about Levaquin.

“We’re thrilled with the outcome and feel the jury followed the evidence and came to the right decision,” Schedin’s attorney, Mikal Watts, said in an interview after the verdict. “They sent a clear message: Pharmaceutical companies should put their patients ahead of their profits.”

A status conference on cases in federal court in Minnesota will be held “right after” the first of the year, U.S. District Judge John R. Tunheim, who is overseeing those suits, said in court today.

Case Conference

The next case for trial should be selected at this conference, Lewis Saul, a plaintiffs’ attorney, said in an interview today.

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,” Watts 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.”

430 Million Prescriptions

The drug has been prescribed more than 430 million times worldwide, company lawyers said in a court filing last month. Sales of the drug through the first nine months of the year totaled $957 million, the company said in an Oct. 19 statement.

J&J and Ortho-McNeil-Janssen 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.

Ortho-McNeil-Janssen denied Schedin’s claim that it acted with deliberate disregard for safety.

“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-Janssen 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.

Prescribed for Infection

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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