Levaquin Trial Consolidation for Bellwether Cases Opposed by J&J

Johnson & Johnson is fighting attempts by plaintiffs in the federal litigation over their popular antibiotic, to consolidate the first three bellwether lawsuits into one Levaquin trial.

The drug company, and its subsidiary, Ortho-McNeil Pharmaceutical, Inc., face hundreds of Levaquin lawsuits in state and federal court involving allegations that users suffered a tendon rupture or other tendon problems. The federal Levaquin cases have been consolidated and centralized as part of a multidistrict litigation, or MDL, in the U.S. District Court for the District of Minnesota, where it is anticipated that the first trials could begin in August 2010.

The first cases selected for trial in the Levaquin litigation, known as Bellwether trials, are designed to evaluate how a jury will respond to issues that will also be presented throughout other cases, and possibly lay the groundwork for a potential Levaquin settlement.

On November 6, Johnson & Johnson filed an opposition to a motion by plaintiffs to combine three of the Bellwether cases into one trial. The plaintiffs proposed that the lawsuits are similar enough in claims, injury and situation that it would be expedient and efficient for the court to handle them as one trial.

Johnson & Johnson objected to the consolidated Levaquin trial, arguing that the plaintiffs have not shown that the benefits of combining the cases would outweigh the individual issues in each case. Johnson & Johnson argues that potential differences in plaintiffs’ medical histories, what each prescribing physician knew about Levaquin side effects, and the unique injuries suffered by each plaintiff are likely to cause jury confusion and prejudice the drug maker if evidence that would be inadmissible in one trial is allowed in a multi-plaintiff trial.

The plaintiffs have pointed out that in similar past cases, juries were able to split verdicts between plaintiffs if such differences arose.

Levaquin (levofloxacin), which is part of a class of medications known as fluoroquinolones, was approved by the FDA in December 1996. It is prescribed to prevent infection by stopping the reproduction of bacteria. However, it has also been found to be toxic to the tendons, leading to an increased risk of tendon damage, including debilitating ruptures of the Achilles tendon.

In July 2008, the FDA required that a “black box” tendon damage warning be added about the side effects of Levaquin and other similar antibiotics. However, consumer advocates called for stronger warnings about the Levaquin tendon rupture problems at least two years earlier, with Public Citizen filing a petition with the FDA in 2006 insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage from the class of antibiotics.

In addition to the federal Levaquin litigation Johnson & Johnson faces in the MDL, there are also a number of lawsuits over Levaquin in New Jersey, where the state has consolidated the case for mass tort treatment under Judge Carol Higbee in Atlantic County Superior Court because of the large number of complaints filed involving nearly identical allegations.