Second Levaquin Bellwether Trial Set to Begin May 31

Trial is scheduled to begin early next week for the second Levaquin bellwether lawsuit in the federal MDL, after a jury returned a verdict of $1.8 million in the first bellwether trial over side effects of the popular antibiotic, which occurred late last year.

The case, which was filed by Calvin Christensen, involves allegations that are similar to hundreds of other Levaquin lawsuits filed against Johnson & Johnson and their Ortho McNeil Pharmaceuticals subsidiary, alleging that the drug maker failed to adequately warn about the risk of tendon ruptures from Levaquin.

All lawsuits over Levaquin filed in federal district courts throughout the United States have been centralized as part of an MDL, or multidistrict litigation, in the U.S. District Court for the District of Minnesota before U.S. District Judge John Tunheim.

A handful of cases, known as bellwether lawsuits, were selected for early trials in the MDL to help the parties gauge the relative strengths and weaknesses of their cases, by determining how juries respond to evidence that is likely to be similar throughout many cases in the litigation. The results of the bellwether trials may help facilitate a potential Levaquin settlement agreement.

According to a Pretrial Order issued by Judge Tunheim, a final pretrial conference has been scheduled for tomorrow, with trial scheduled to commence after the holiday weekend, at 9:00 a.m. on Tuesday morning.

Levaquin (levofloxacin) is an antibiotic approved by the FDA in 1996 to prevent infection by stopping the reproduction of bacteria. However, it has been linked to an increased risk of tendon damage and tendon ruptures, particularly involving the Achilles tendon.

In July 2008, the FDA required that a “black box” warning be added about the side effects of Levaquin and other similar antibiotics, which is the strongest warning that can be placed on a prescription medication. However, consumer advocates called for Levaquin tendon rupture warnings to be added 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.

The first Levaquin bellwether trial, which involved a lawsuit brought by John Schedin, resulted in a finding that the drug makers were liable for recklessly failing to warn consumers and doctors earlier about the risk of Levaquin tendon ruptures. The jury awarded $700,000 in compensatory damages and another $1.1 million in punitive damages as a penalty against pharmaceutical company.