Bloomberg News

Johnson & Johnson Wins Jury Verdict Over Levaquin Warning

January 26, 2012

(Updates with J&J comment in seventh paragraph.)

Jan. 26 (Bloomberg) -- Johnson & Johnson can’t be held liable for the tendon injuries to a 78-year-old man who said the company didn’t properly warn of the risks of its antibiotic Levaquin, a Minnesota jury said.

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, New Jersey, has denied any failure to warn and contended that Straka needed Levaquin to treat the pneumonia. The Minneapolis federal jury today found that J&J and its unit failed to provide reasonably adequate warnings, while also ruling that this wasn’t the cause of Straka’s injuries. The verdict is the companies’ third straight trial win.

“We are trying to understand how the jury arrived at the verdict,” Ronald Goldser, Straka’s attorney, said in an interview. “If the warning is inadequate, what is it the doctor did wrong?”

Third Minnesota Case

The lawsuit was the third federal case to go to trial in Minnesota alleging the 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.

J&J is facing more than 3,700 claims involving Levaquin in state and federal courts, Bill Foster, a company spokesman, said in an e-mail. The 2010 trial loss has been appealed and 43 cases have been dismissed, he said.

The company is “pleased with the verdict,” Foster said in an e-mail today. “When used according to the product labeling, Levaquin has been proven to be a safe and effective medication.”

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.

‘That’s All’

“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 at trial. “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.”

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,” he said. “This was a very healthy man.” Straka had a tryout with the Green Bay Packers of the National Football League when he was younger and was still physically active, Morris said.

“The label from Day One in 1996 was adequate,” James Irwin, J&J’s lawyer, said in closing arguments Jan. 24. “The information was out there and available to the doctors and everyone else.”

Straka was allergic to other antibiotics and needed a drug in the Levaquin class, Irwin told the jury.

‘Right Choice’

“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).

--With assistance from Jef Feeley in Wilmington, Delaware, and Colby Johnson in Minneapolis. Editors: Mary Romano, Andrew Dunn

To contact the reporters on this story: Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net; Beth Hawkins in Minneapolis at hawkins@visi.com.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.


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