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Levaquin Achilles Tendon Rupture Trial Consolidation Request Denied

U.S. District Judge John Tunheim has denied a motion filed by plaintiffs to consolidate three Levaquin lawsuits, which all involve users who suffered an Achilles tendon rupture or tear after using the antibiotic, into one “bellwether” trial in the federal MDL.

In an order issued Monday, Judge Tunheim indicated that it is premature to decide whether the three cases should be tried together, and suggested that if the plaintiffs renew their motion at the close of discovery, there will be more information about the facts of each case and issues to be presented at trial.

The first Levaquin trials are expected to begin in early August 2010, with discovery in cases selected as part of the early trial pool scheduled to close in April 2010.

There are currently more than 240 lawsuits over Levaquin pending before Judge Tunheim in federal court as part of a multidistrict litigation, or MDL, in the U.S. District Court for the District of Minnesota. All of the cases involve allegations that the drug makers failed to adequately warn about the increased risk of tendon ruptures and other tendon injuries that can occur from side effects of Levaquin.

About another 100 Levaquin suits are pending in various state courts throughout the country, and Levaquin lawyers who are continuing to investigate cases expect that the total number of claims will ultimately be in the thousands.

Fifteen Levaquin lawsuits were originally selected by the parties as part of the “bellwether” process in the MDL, which involves the selection of a handful of cases for early trials to give the parties and the court insight into how juries will digest evidence and testimony that is likely to be presented throughout the litigation. Through pretrial proceedings, the parties are currently considering seven of the cases for the first trials.

In a motion filed in October, plaintiffs asked the court to combine three of the cases for the first trial. Plaintiffs argued that consolidation would promote judicial efficiency and the interests of justice, while testing the merits of arguments likely to be repeated in other cases.

The three Levaquin cases proposed for a combined trial all involved plaintiffs who used the antibiotic for a respiratory infection together with a corticosteroid, they were all in the same age group, took the drug while the same warnings were on the label and each suffered an Achilles tendon rupture or tear before completing their course of Levaquin.

Defendants opposed the combined trial, arguing that the individual medical history and knowledge of each doctor about the risk of tendon ruptures from Levaquin should prevent the cases from being tried together.

Judge Tunheim agreed that the consolidation would be expedient, but said that discovery and other factors in the lawsuits have not progressed far enough to justify consolidation.

“The merits of the parties’ arguments have not been tested at trial, in dispositive motions, or through some out-of-court resolution,” Tunheim said in his order. “Further, the stakes are high: the initial bellwether trials in this MDL may serve as the basis for the parties’ resolution of remaining, pending cases. Thus, although plaintiffs appear to have demonstrated significant commonalities in fact and law among the three individual plaintiffs’ cases, this motion is premature.”

Levaquin (levofloxacin), is part of a class of medications known as fluoroquinolones, and 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.

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