New Levaquin Product Approved by FDA despite Litigation
The FDA has tentatively approved a new generic Levaquin product, as Levaquin side effects litigation enters a new phase.
The product, a generic Levaquin oral solution manufactured by Hi-Tech Pharmacal Co. Inc., was this month cleared by the FDA to receive final approval in June 2011, when the first brand-name Levaquin patent expires.
Levaquin tendon rupture poses a painful risk to consumers
Levaquin, manufactured by Johnson & Johnson’s Ortho-McNeil-Janssen Pharmaceuticals Inc., is a popular broad-spectrum antibiotic used to treat various mild to severe bacterial infections. The drug and antibiotics like it have been found to put users at risk of severe side effects, most notably Levaquin tendon rupture.
In July 2008, the FDA required Levaquin carry a “black box” warning for tendon rupture. By that time, many users had already suffered Levaquin tendon rupture.
Today, more than 2,600 Levaquin lawsuits are awaiting trial in state and federal courts. The vast majority involve claims of Levaquin tendon rupture.
On Wednesday, representatives for plaintiffs and the defense met during a Levaquin multidistrict litigation (MDL) status conference to discuss how Levaquin litigation will play out following the culmination of the first Levaquin lawsuit trial.
First Levaquin settlement reached
In December, plaintiff John Schedin, who ruptured both Achilles during Levaquin treatment, was awarded $1.8 million in punitive and compensatory damages by a Minnesota jury.
At the status conference, attorneys were scheduled to discuss post trial motions for the Schedin case, as well as details for the next federal Levaquin lawsuit, which is scheduled to begin on May 31. The plaintiff in that case is an elderly man named Calvin Christensen.
Approved by the FDA in 1996, Levaquin generated more than $1.3 billion for Johnson & Johnson in 2009, making it one of the best-selling antibiotics on earth.
To date, there have been no publicized Levaquin settlements.