Bloomberg News

J&J Didn’t Warn Levaquin Riskier Than Rivals, Lawyer Argues

October 12, 2011

(Updates with excerpts from closing arguments starting in third paragraph.)

Oct. 12 (Bloomberg) -- 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 today.

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.

“They should be held to account for not fully disclosing” that they knew Levaquin generated a higher number of reports of Achilles tendon injuries than competing antibiotics, Alonso told a state court jury in Atlantic City, New Jersey, today.

The case 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 today 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 today.

$1 Billion Sales

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.

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 $1.8 million 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.

Both Gaffney, 67, and Beare, 72, got Levaquin prescriptions to deal with bronchitis brought on by sinus infections, according to court filings. Both men wound up with Achilles- tendon injuries that left them unable to walk for a time and required surgery.

Adequate Warning?

Jones noted in her summation that both men had preexisting health conditions that played a role in their tendon injuries and their own doctors refused to blame Levaquin for the ruptures. She also argued that regulatory officials didn’t require the J&J unit to include information about the comparative risks of Levaquin and other antibiotics on the product’s label.

Gaffney and Beare had “significant problems before they were prescribed Levaquin,” she said.

Alonso acknowledged the two men had tendon problems before they took the drug. He argued that Levaquin exacerbated those problems and led to tendon ruptures.

“Nobody had more information about this drug than J&J and they didn’t share it,” the lawyer said. Given that omission, jurors should find the J&J unit didn’t provide an adequate warning about the drug’s risk, Alonso added.

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

--With assistance from Margaret Cronin Fisk in Southfield, Michigan, and Beth Hawkins in Minneapolis. Editors: Glenn Holdcraft, Stephen Farr

To contact the reporter on this story: Jef Feeley in Atlantic City, New Jersey, at jfeeley@bloomberg.net

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


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