Johnson & Johnson Warned on Levaquin Risk, Lawyer Says

Johnson & Johnson didn’t hide the risk of tendon damage linked to its antibiotic Levaquin and properly warned doctors, a lawyer for the drugmaker told jurors at the end of a trial in Minnesota.

“The information was not concealed,” John Dames, a J&J attorney, said today in his closing argument in federal court in Minneapolis. “We provide warnings that give doctors the means to care adequately for their patients.”

John Schedin, 82, sued in 2008, claiming he ruptured the Achilles tendons in both feet after taking the drug. Schedin claims J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit failed to warn doctors and patients of Levaquin’s association with tendon damage.

Schedin’s case is the first trial on more than 2,600 claims in U.S. courts alleging that Levaquin caused tendon damage in patients taking the drug and J&J failed to adequately disclose the risk. The U.S. Food and Drug Administration in 2008 required an upgraded warning on tendon damage posed by Levaquin and similar drugs.

The plaintiffs claim the warning should have been enhanced earlier and remains inadequate. They also claim 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 in his closing argument today. “It was a one-drug franchise that was crucial to the health of this company.”

Schedin claims Ortho-McNeil violated Minnesota’s consumer fraud act by concealing or misrepresenting information. The jury of eight men and four women will first consider liability and his claim for unspecified actual damages. Schedin is also seeking punitive damages.

“There is no proof that Levaquin caused Mr. Schedin’s tendon rupture,” Dames said today. “There is no proof that Levaquin has more risk of tendon rupture” than similar drugs, he said.

Warning Enhanced

The FDA in 2008 required J&J and makers of other drugs in the class of antibiotics called fluoroquinolones to include a “black box,” or enhanced warning 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.

“When the black box eventually happened, they studied it and estimated it was going to cost them $700 million a year,” Watts said today. “They didn’t want to part with $700 million a year.”

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.

“Levaquin is a life-saving drug,” defense attorney Dames said today. “That opinion was shared by all of the experts who testified in this case.”

The lawsuit 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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