Bloomberg News

J&J Unit Cleared of Liability for Alleged Levaquin Injuries

October 14, 2011

(Updates with company comment in fourth paragraph, comment from plaintiffs’ lawyer in eighth paragraph.)

Oct. 14 (Bloomberg) -- A unit of Johnson & Johnson isn’t responsible for tendon damage suffered by two New Jersey men who took the drugmaker’s Levaquin antibiotic, a jury found.

The state court jury in Atlantic City, New Jersey, deliberated about eight hours over two days before clearing J&J’s Ortho-McNeil-Janssen Pharmaceutical unit of liability for Paul Gaffney’s and Robert Beare’s injuries. The two men contend their Achilles tendon snapped after they took Levaquin to treat respiratory infections.

It’s the company’s second win in a Levaquin case. In June, a Minnesota jury rejected a man’s claim that the antibiotic caused his Achilles injury. Another Minnesota jury in December 2010 awarded another former Levaquin user a total of $1.8 million in damages over his tendon injury.

“The evidence showed Ortho-McNeil-Janssen Pharmaceuticals properly informed of the benefits and risks associated with the use of Levaquin and that the company acted responsibly by providing appropriate and timely information about” the drug, William Foster, a spokesman for the J&J unit, said in an e- mailed statement.

Levaquin, which generated more than $1 billion in sales over an eight-year period starting in 2000, was J&J’s third- largest selling product at one point. In 2008, the U.S. Food and Drug Administration required all makers of antibiotics in Levaquin’s class to beef up warnings about tendon ruptures.

‘Obviously Disappointed’

Regulators required the upgraded warnings after finding that the antibiotics increased the risk of tendon ruptures to three to four times that of the general population, FDA officials said.

J&J faces more than 2,600 claims in U.S. courts blaming Levaquin for causing users’ tendon damage, court dockets show.

“We’re obviously disappointed with the verdict,” Andy Alonso, a lawyer for Gaffney and Beare, said in an interview after the panel announced its decision. “We felt the evidence was clear that the warnings were flawed. The jury felt otherwise.”

Both Gaffney, 67, and Beare, 72, got Levaquin prescriptions to deal with sinus infections that developed into bronchitis, their lawyers told jurors during the trial. Both men wound up with Achilles-tendon injuries that left them unable to walk and required surgery.

Adequate Warning

Lawyers for the plaintiffs argued that officials of the J&J unit knew Levaquin posed the highest risk of tendon damage of all the antibiotics in its class and failed to include that information on the drug’s warning label. That failure meant patients and doctors didn’t have an adequate warning of the antibiotics health risks, they alleged.

Attorneys for the J&J unit countered that federal regulators didn’t require such “comparative risk” information in drug labels. In addition, the drugmaker included warnings about Levaquin’s potential effects on tendons on labels stretching back to 1996, they added.

Jurors voted 8-1 in finding the J&J unit’s Levaquin warnings were proper. Even if they had ruled against the drugmaker, Judge Carol Higbee had barred the panel from considering punitive damages in the case under New Jersey law.

The case is Beare v. Johnson & Johnson, L-196-10-MT, Superior Court of New Jersey for Atlantic County (Atlantic City).

--Editors: Glenn Holdcraft, Andrew Dunn

To contact the reporter on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net

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


Best LBO Ever
LIMITED-TIME OFFER SUBSCRIBE NOW
 
blog comments powered by Disqus