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J&J unit didn’t hide drug risks, lawyer says

Johnson & Johnson properly warned of the risks of its antibiotic Levaquin and shouldn’t be held liable for tendon injuries sustained by a 78-year-old man, a company lawyer said at the end of a trial in Minneapolis.

Clifford Straka, who blew out two Achilles tendons after taking the drug for pneumonia, sued J&J and its Ortho-McNeil Pharmaceutical unit in 2008. Straka said his doctor wasn’t aware when she prescribed the drug that Levaquin was linked to an increased risk of tendon damage in elderly patients.

Johnson & Johnson, based in New Brunswick, N.J., has denied any failure to warn and contended that Straka needed Levaquin to treat the pneumonia.

“The label from day one in 1996 was adequate,” James Irwin, J&J’s lawyer, said in closing arguments Tuesday. “The information was out there and available to the doctors and everyone else.”

The lawsuit is the third federal case to go to trial in Minnesota alleging J&J and its unit, now known as Janssen Pharmaceuticals, downplayed the risks of the antibiotic to boost sales. J&J lost the first, a jury verdict for $1.8 million in 2010, and won the second last year. The company also won the first state case in October, when a New Jersey jury rejected the claims of two plaintiffs.

Tendon ruptures

J&J is facing more than 3,700 claims involving Levaquin in state and federal courts, Bill Foster, a company spokesman, said in an email. The lone trial loss has been appealed and 43 cases have been dismissed, he said.

In 2008, the U.S. Food and Drug Administration required all makers of antibiotics in Levaquin’s class, called fluoroquinolones, to increase warnings about tendon ruptures. Straka, who was injured in 2006, claims J&J should have enhanced the drug’s warning before the FDA required it.

“In 2001, all they did was insert one additional sentence into the label mentioning the elderly and corticosteroids,” Jim Morris, Straka’s lawyer, said in his closing argument Tuesday. “That’s all.”

The company “knew that this product had a relationship” to tendon injuries, Morris said. “But they didn’t study its frequency. They don’t know whether it’s rare.”

‘Healthy’ man

Straka didn’t require Levaquin to save his life, Morris said. “This was not a situation where Clifford Straka was in the hospital about to die of pneumonia. This was a very healthy man.” Straka had a tryout with the Green Bay Packers when he was younger and was still physically active, Morris said.

Straka was allergic to other antibiotics and needed a drug in the Levaquin class, Irwin, J&J’s lawyer, told the jury Tuesday.

“Levaquin was the right choice,” he said. “When you consider those allergies, you’re really only left with the fluoroquinolones.” The chance of tendon rupture was rare, he said.

“Mr. Straka’s adverse event, his tendon rupture, we don’t like this occurring in any of our patients,” he said. “But this is a great medicine. We all know it was saving lives throughout this entire trial.”

The case is Straka v. Johnson & Johnson, 08-05742, combined for trial in In re Levaquin Products Liability Litigation, 08- md-01943, U.S. District Court, District of Minnesota (Minneapolis).