Bloomberg News

J&J Failed to Warn About Drug’s Tendon Risks, Lawyer Says

September 06, 2011

(Updates with share price in 16th paragraph.)

Sept. 6 (Bloomberg) -- Johnson & Johnson failed to properly warn two New Jersey men that the antibiotic Levaquin could damage their tendons, a lawyer told a state jury.

Officials of New Brunswick, New Jersey-based J&J and its Ortho-McNeil-Janssen Pharmaceutical unit downplayed Levaquin’s risks in warning labels even after receiving reports from Europe about tendon ruptures, said Andy Alonso, a lawyer for Paul Gaffney and Robert Beare. The two men contend they suffered Achilles-tendon injuries after taking the antibiotic.

“J&J officials knew there was a problem and did everything they could to hide it” to protect Levaquin’s sales, Alonso told jurors today in opening statements in state court in Atlantic City, New Jersey.

A J&J lawyer countered today that the drugmaker repeatedly warned doctors and patients about reports linking tendon ruptures to Levaquin, starting when it was approved for sale in the U.S. in 1996.

“From the very first label, Johnson & Johnson included information about reports of ruptures of the shoulder, hand and Achilles tendon,” Christy Jones, the company’s lawyer, told jurors in her opening statement.

The Atlantic City 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.

Blockbuster Drug

In December, a federal-court jury in Minnesota ordered J&J to pay $1.8 million in damages to 82-year-old man who alleged Levaquin caused his Achilles tendon to rupture. In June, another jury in that same court rejected an 84-year-old man’s claim over his Achilles injury.

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.

Both Gaffney, 67, and Beare, 72, got Levaquin prescriptions to deal with sinus infections, Alonso told jurors. Both men wound up with Achilles-tendon injuries that left them unable to walk and required surgery.

‘Downplayed the Risks’

Instead of putting a prominent warning about tendon risks on Levaquin’s label, J&J officials hired ghostwriters to craft articles touting the antibiotic’s safety and effectiveness, Alonso said.

“They downplayed the risks of this product” in their marketing materials, he said.

Jones countered that Gaffney and Beare had other ailments that could have caused their Achilles tendon problems. The pair also may have contributed to the injuries through their actions, she added.

“It’s unlikely that either one of the plaintiffs would have suffered a tendon rupture if they’d followed their doctors’ advice,” Jones said.

FDA regulators were aware of reports of tendon problems associated with the drug when they repeatedly approved it as safe and effective, she said.

Lawyers for both sides estimated the trial, before Judge Carol Higbee, would last about four weeks.

J&J rose 30 cents to $64.37 in New York Stock Exchange composite trading at 3:04 p.m. The shares gained 3.6 percent this year before today.

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

--With assistance from David Voreacos in New York, 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 Wilmington, Delaware, at jfeeley@bloomberg.net

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


Ebola Rising
LIMITED-TIME OFFER SUBSCRIBE NOW
 
blog comments powered by Disqus