Judge Allows Release of Documents from Levaquin Lawsuit

The federal judge presiding over thousands of Levaquin lawsuits filed by individuals who have suffered tendon ruptures after using Johnson & Johnson’s popular antibiotic, has agreed to release previously confidential company documents that were introduced at the first trial, where a jury awarded $1.8 million in compensatory and punitive damages as a result of the drug maker’s failure to warn about the side effects of Levaquin

Levaquin (levofloxacin) is an antibiotic manufactured by the Johnson & Johnson’s subsidiary Ortho-McNeil-Janssen Pharmaceuticals, which is used 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.

Johnson & Johnson currently faces about 2,600 Levaquin tendon rupture lawsuits that have been filed in state and federal courts throughout the United States. All federal cases have been consolidated and centralized for pretrial proceedings as part of a multidistrict litigation, or MDL, before U.S. District Judge John R. Tunheim in the U.S. District Court for the District of Minnesota.

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Following the first trial in the MDL, which ended in December 2010, plaintiffs requested that the Court unseal approximately 115 documents that were admitted at the close of trial, but not discussed during testimony in open court. The documents were previously sealed under a protective order.

Despite Johnson & Johnson’s attempts to keep the documents from the public, Judge Tunheim ordered last week that the documents be released together with a punitive damages order that referenced some of the documents, finding that the drug maker failed to meet the burden necessary to overcome the presumption in favor of publication of evidence submitted at trial. The Court determined that the right for public access to trial documents outweighs the company’s concerns, and determined that the drug manufacturer failed to give the court sufficient reason to keep the documents secret.

The documents were introduced during the trial of a Levaquin lawsuit brought by John Schedin, who suffered bilateral Achilles tendon ruptures after using Levaquin for eight days to treat an upper respiratory infection.

At the time Schedin used the medication, Levaquin contained warnings about tendon ruptures, but the jury found that the warning was inadequate to inform him of the risk associated with using Levaquin and awarded $700,000 in compensatory damages. Based upon these documents and other evidence admitted at trial, the jury also awarded $1.1 million in punitive damages after finding that the drug maker abused its control over information about risks associated with the product in a manner that showed a disregard for public safety.

One of Johnson & Johnson’s arguments was that the documents would cause the company to face “adverse publicity” which could affect future lawsuits. However, Judge Tunheim pointed out that the company already has adverse publicity from the punitive damages award, and said that argument was not strong enough.

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.

A second Levaquin bellwether trial is scheduled to start before Judge Tunheim on May 31.


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