Comparative risk

J&J didn't warn Levaquin riskier than rivals, lawyer argues

A Johnson & Johnson unit never warned users of the Levaquin antibiotic that it posed a greater risk of tendon damage than rival medications, a lawyer for two men suing the company said yesterday.

Executives of J&J's Ortho-McNeil-Janssen Pharmaceutical unit sought to protect sales by omitting information about Levaquin's "comparative risk" from its warning label, Andy Alonso, a lawyer for Paul Gaffney and Robert Beare, said in closing arguments in the trial of their lawsuits against the drugmaker.

The case, in state court in Atlantic City, New Jersey, is the third over Levaquin tendon injuries to go to trial since November and the first to be tried in New Jersey state courts. J&J faces more than 2,600 claims in U.S. courts over the drug, court dockets show.

A lawyer for the J&J unit countered that for more than a decade starting in 1996, Levaquin's labels contained repeated warnings about the risk of tendon injuries associated with the drug.

Gaffney's and Beare's own doctors said "they were aware" of the tendon risk posed by the drug, Christy Jones, one of the drugmaker's lawyers, told jurors in her closing argument yesterday.

Levaquin, which generated more than $1bn 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.

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.

Lawyers for a Minnesota man relied on the FDA's push for stronger warnings on the class of antibiotics that included Levaquin to convince a federal court jury in December 2010 to award him a total of $1.8m in damages over tendon damage he blamed on the drug. A separate jury in June rejected another former Levaquin user's claim for damages over his Achilles- tendon injury.

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

(Published by Bloomberg - October 13, 2011)

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