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J&J Wins Trial Over Claims Antibiotic Levaquin Caused Injuries

Johnson & Johnson isn’t responsible for a tendon injury sustained by an 84-year-old man and properly warned of the risks posed by its antibiotic Levaquin, a Minneapolis jury decided.

Calvin Christensen, who said he ruptured the Achilles tendon in his right foot after taking the drug while hospitalized for pneumonia, sued the company and its Ortho-McNeil Pharmaceutical unit in 2007. Christensen said the companies downplayed the risks of Levaquin to boost sales of the drug.

Johnson & Johnson denied any failure to warn and contended Christensen needed Levaquin to treat the pneumonia. The Minneapolis federal court jury rejected his claim yesterday.

“The jury took a good, hard look at all the evidence and correctly concluded that Ortho-McNeil-Janssen Pharmaceuticals, Inc. acted responsibly and properly in disclosing the risks associated with this effective and life-saving medicine,” James B. Irwin, a lawyer for the company, said in a statement after the verdict.

Christensen’s case is the second of more than 2,500 pending claims in U.S. courts to go to trial over allegations that Levaquin caused tendon damage in patients and that the company failed to adequately disclose the risk. J&J and Ortho-McNeil lost the first trial when a separate Minneapolis jury awarded $1.8 million to an 82-year-old man who ruptured both Achilles tendons.

‘Disappointed’ Plaintiff

Ron Goldser, a lawyer for the plaintiff, said in a brief interview that his side is “disappointed.”

The trial began June 1.

The U.S. Food and Drug Administration in 2008 required an upgraded warning on tendon damage by Levaquin and similar drugs.

Christensen claimed the warning should have been enhanced earlier and that Johnson & Johnson and Ortho-McNeil, now Ortho-McNeil-Janssen, targeted the elderly for drug sales.

The Levaquin label “has included warnings about tendinitis and tendon ruptures,” since it was first approved by the FDA in 1996, Bill Foster, a J&J spokesman, said in an e-mail before trial.

Levaquin had U.S. sales of $1.3 billion in 2010 and $422 million in the first quarter of 2011. Levaquin, a member of a class of antibiotics called fluoroquinolones, was developed to treat serious and life-threatening infections, Foster said.

Millions of Prescriptions

The drug has been prescribed more than 430 million times worldwide, company lawyers said in court papers last year.

The FDA in 2008 required Johnson & Johnson and makers of other drugs in the class to include a so-called black box or enhanced warning on the risk of tendon ruptures. The risk was higher in patients older than 60, those taking steroids, or who have had kidney, heart or lung transplants, the FDA said.

J&J was aware of the increased risk before adding the black box warning, Christensen said in his complaint. Regulatory officials in France, Italy and Belgium sent out so-called Dear Doctor letters of the risk of tendon injury among the elderly in 2002, Christensen said.

Ortho-McNeil upgraded its warning in the U.S. in 2002, adding the increased risk to patients taking steroids, particularly elderly patients, Christensen said. This wasn’t enough, because Ortho-McNeil didn’t send out Dear Doctor letters in the U.S. about the change and “muted” the additional warning, he said in court papers.

Label Change

Johnson & Johnson changed the label on its own after reviewing initial data from Europe in 2001, Irwin said yesterday in closing arguments.

“That’s how we like to see corporate America do things,” he said.

Christensen, who took the drug in May 2006, required surgery after rupturing his right Achilles tendon and was left with “permanent instability and loss of balance,” according to his complaint. “Even with immobilization for long periods of time and physical therapy, the Achilles tendons in the elderly rarely fully recover,” he said in court papers.

Christensen needed Levaquin to treat his pneumonia, Irwin said.

“All medicines have risks and benefits, we all know that,” said Irwin said. “A huge benefit outweighs the risk of harm.”

Christensen’s doctor was aware of the warning of tendon ruptures on the Levaquin label, Irwin said. The doctor prescribed Levaquin to Christensen because “it was important to get him home,” Irwin said.

‘Other Drugs’

“There were lots of other drugs available for Calvin,” his lawyer, Ronald Goldser, said at trial yesterday. “Did he have an alternative? Of course, he did.”

Goldser played a portion of a video deposition of Christensen’s doctor, Greg Clark, in his closing argument. In the deposition, Goldser asked Clark if he would have prescribed Levaquin if he knew then what he now knows about the drug.

“We should have considered alternatives for him,” Clark replied.

“Johnson & Johnson failed to provide Dr. Clark complete and proper information in a manner intended to attract notice,” Goldser said.

The lawsuit is Christensen v. Johnson & Johnson, 07-03960, 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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