Johnson & Johnson Hid Antibiotic Levaquin Risk, Lawyer Says

A Johnson & Johnson unit knew its antibiotic Levaquin increased the risk of tendon damage in the elderly and failed to properly warn patients or doctors, a lawyer said today at the start of a trial in Minnesota.

Calvin Christensen, 84, 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. The companies downplayed the risks of Levaquin to boost the drug’s sales, Christensen’s lawyer, Saul Lewis, said in his opening statement.

“Johnson & Johnson hid the risk from doctors and the public,” Saul told the Minneapolis jury today. “They sold $15 billion worth of Levaquin in the U.S.”

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 84-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.

‘Tendon Ruptures’

The companies deny any failure to warn. The Levaquin label “has included warnings about tendonitis and tendon ruptures,” since it was first approved by the FDA in 1996, Bill Foster, a J&J spokesman, said in an e-mail.

“Additionally, the evidence will show that the plaintiff’s prescribing physician was aware of the risks of Levaquin, including the risk of tendon rupture in elderly patients,” he said.

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.

“It’s a blockbuster because it does just what our credo says,” James Irwin, a J&J lawyer, said today in his opening statement. “Our credo says we put patients and doctors first.”

J&J studied Levaquin’s side effects and properly informed the FDA and the public, Irwin told the jury.

“It was suggested we were trying to hide the ball,” he said. “We were ahead of everyone else.”

Black-Box Warning

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.

‘Diffused Effect’

“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. This “diffused any possible effect of warning physicians of the effect of age,” 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.

“If Johnson & Johnson had properly warned his doctor, the injury would not have occurred,” Ronald Goldser, one of his attorneys, said in court today. “His doctor would have prescribed a different drug.”

‘One in 8,000’

“No one was worried about a one in 8,000 chance of Achilles rupture,” Irwin, the J&J lawyer, said today. “Everyone was worried about getting Calvin Christensen home to his wife.”

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. Another 1,512 cases are pending in New Jersey, with the rest in other states, 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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