Johnson & Johnson settled lawsuits with about 845 plaintiffs who claimed the drugmaker didn’t properly warn of the risks of tendon damage from its antibiotic Levaquin.
The settlements were disclosed in an Oct. 30 filing in federal court in Minneapolis, where a judge is overseeing about 1,900 Levaquin lawsuits. The initial agreements will be completed in the next two weeks, the plaintiffs said in the filing, which didn’t say how much Johnson & Johnson would pay.
According to the filing, Johnson & Johnson faces more than 3,400 state and federal lawsuits alleging tendon injuries from the drug, including about 1,500 cases in New Jersey state court.
Johnson & Johnson has won three of the four Levaquin cases that have gone to trial. It lost the first, a jury verdict for $1.8 million in 2010. Settlement discussions are under way with about 190 other plaintiffs, according to the filing.
“As part of reaching a settlement agreement, the parties are also working toward developing a standardized settlement protocol through which plaintiffs will submit cases for an evaluation of whether, and to what extent, their cases are compensable,” Johnson & Johnson and the plaintiffs said in the filing.
“There are settlement discussions under way,” William Foster, a spokesman for New Brunswick, New Jersey-based Johnson & Johnson, said in an e-mailed statement. “The current settlement discussions reflect the strength of the company’s evidence presented at several trials about a medicine that saves lives.”
Terms of the agreements are confidential, he said.
Plaintiffs’ counsel Ronald Goldser didn’t immediately return a call for comment on the settlements.
The plaintiffs claim that Johnson & Johnson and its Ortho-McNeil Pharmaceutical unit failed to sufficiently warn that Levaquin was linked to an increased risk of tendon damage in elderly patients. The plaintiffs say Johnson & Johnson downplayed the risks to boost sales.
Johnson & Johnson has denied any failure to warn. The company will continue to dispute the allegations in lawsuits brought by plaintiffs who aren’t involved in settlement talks, Foster said.
“The evidence will show the company properly warned of the risks of tendon events from use of Levaquin and acted responsibly by providing appropriate and timely information about Levaquin to the medical, scientific and regulatory communities,” he said.
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. The plaintiffs claim Johnson & Johnson should have enhanced the warning before the FDA required it.
The federal lawsuits are combined in In re Levaquin Products Liability Litigation, 08-md-01943, U.S. District Court, District of Minnesota (Minneapolis).