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Johnson & Johnson Properly Warned of Drug Risk, Lawyer Says

Johnson & Johnson properly warned of the risks of its antibiotic Levaquin and isn’t responsible for a tendon injury sustained by an 84-year-old man, a lawyer for the company said in closing arguments at a Minneapolis trial.

Calvin Christensen, who said he ruptured the Achilles tendon in his right foot after taking the drug while hospitalized with pneumonia, sued the company and its Ortho-McNeil Pharmaceutical unit in 2007. There was no failure to warn and Christensen needed Levaquin to treat the pneumonia, said attorney James Irwin, J&J’s lawyer.

“All medicines have risks and benefits, we all know that,” Irwin said today in his closing argument in federal court in Minneapolis. “A huge benefit outweighs the risk of harm.”

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.

The U.S. Food and Drug Administration in 2008 required an upgraded warning on tendon damage posed by Levaquin and similar drugs. Christensen claims the warning should have been enhanced earlier and that Johnson & Johnson and Ortho-McNeil, now Ortho-McNeil-Janssen, targeted the elderly for drug sales.

‘Included Warnings’

The Christensen trial began June 1.

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.

Christensen’s physician, “being a good doctor, read that label and he knew that,” Irwin told the jury today. The doctor prescribed Levaquin to Christensen because “it was important to get him home,” Irwin said.

“There were lots of other drugs available for Calvin,” his lawyer, Ronald Goldser, said at trial today. “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 today. In the deposition, Goldser asked Clark if he would have prescribed Levaquin if he knew then what he now knows about the drug.

‘Considered Alternatives’

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

Goldser asked the jury to award unspecified compensatory and punitive damages. The jury of nine women and three men will begin deliberations today.

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.

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.

Dear Doctor Letters

J&J was aware of the increased risk before adding the black box warning, Christensen said in his complaint. He claims the companies downplayed the risk to boost the drug’s sales.

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.

“Rather than warn that the risk of tendon injury was increased (tripled) in the elderly, the warning stated that the risk was possibly increased in those using corticosteroids,” he said in his amended complaint in June 2008. This implied that an elderly patient who wasn’t on steroids had no additional risk of tendon injury, Christensen said.

‘Permanent Instability’

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.

Johnson & Johnson changed the label on its own after reviewing initial date from Europe in 2001, Irwin, the company lawyer said, today. “That’s how we like to see corporate America do things.”

“We say they did that preemptively to avoid problems with the FDA,” Goldser, Christensen’s lawyer, said. “Johnson & Johnson failed to provide Dr. Clark complete and proper information in a manner intended to attract notice.”

Almost 1,000 claims over Levaquin side effects are combined as a multidistrict litigation, or MDL, in federal court in Minneapolis before U.S. District Judge John R. Tunheim. Most of the rest, about 1,500, are pending in New Jersey, according to court filings.

In the first trial on Levaquin claims in the MDL, a Minneapolis jury in December awarded plaintiff John Schedin $700,000 in actual damages and $1.1 million in punitive damages. The jury found Schedin 10 percent liable for the injury. Ortho-McNeil filed for a new trial in April.

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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