Discovery in Levaquin Lawsuits Over Nerve Damage Moving Forward in MDL

An initial case management plan has been issued by the U.S. District Judge presiding over all federal Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits brought on behalf of individuals who have suffered debilitating nerve damage from the popular antibiotics, outlining the protocol and limitations for discovery during the early stages of the litigation.

There are currently about 400 product liability lawsuits pending against the manufacturers of the fluoroquinolone-based antibiotics throughout the federal court system, each involving similar allegations that consumers and the medical community were not adequately warned about the risk of peripheral neuropathy.

Given the similar questions of fact and law raised against each of the drug makers, the cases are currently consolidated for pretrial proceedings before U.S. District Judge John R. Tunheim in the District of Minnesota, as part of a federal MDL or multidistrict litigation. The centralized litigation is designed to streamline discovery, avoid conflicting pretrial rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.

On April 26, Judge Tunheim issued a pretrial order (PDF) that establishes an initial case management plan designed to ensure the efficiency of the MDL. It maps out how the discovery proceedings for the antibiotic nerve damage claims will proceed and provides some early deadlines for certain phases of the discovery proceedings.

The plan indicates non-expert fact discovery into common issues in the cases will begin as soon as practical and conclude by May 31, 2017 for cases involving Levaquin, by July 31, 2017 for Avelox cases and by September 29, 2017 for Cipro cases.

Prior to a status conference scheduled for next month, plaintiffs were directed to submit a proposal regarding the selection of a small group of lawsuits that will go through case-specific discovery in preparation for early “bellwether” trials. By September 2016, the drug makers will submit their proposals.

Given the common discovery deadlines, it appears unlikely that the first bellwether trials will go before a jury until mid-to-late 2018, at the earliest. In complex pharmaceutical litigation, where a large number of claims raise similar allegations, such test trials are used to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation. While the outcome of these trials are not binding on other cases, they may influence eventual antibiotic nerve damage settlements that would avoid the need for hundreds of individual cases to go to trial.

Fluoroquinlone Antiobiotic Risks

The litigation has emerged since the FDA required makers of all fluoroquinolones to update the warning labels in August 2013, adding information about the risk that nerve damage may be permanent.

While prior warnings provided with drugs like Levaquin, Avelox and Cipro indicated that some users experienced temporary nerve damage in rare cases, plaintiffs allege that the drug makers should have provided much stronger warnings and disclosed the risk of long-lasting nerve damage, which may last for months or even years.

Peripheral neuropathy involves damage to the nerves that may impair sensation, movement and other aspects of health. This may leave users with persistent pain, burning, tingling, numbness, weakness and sensitivity to light touches, temperature and motion in the arms and legs, as well as other problems that cause a major disruption to daily activities.

Plaintiffs allege that the makers of Levaquin, Avelox and Cipro should have provided these warnings years ago, noting that the first indication of a possible link between long-term peripheral neuropathy and fluoroquinolone antibiotics came in a study published in 2001. If adequate warnings had been provided about the risk of permanent neuropathy problems, plaintiffs indicate that they may have avoided painful and debilitating injuries.

While Levaquin, Avelox and Cipro are widely used antibiotics, they have been linked to a number of serious health risks. One of the latest concerns to emerge involve the risk of aortic dissection and aortic aneurysm from the antibiotics.

In a study published in October 2015 in JAMA Internal Medicine, researchers found that fluoroquinolones may cause the main artery in the human body to become enlarged. While most incidents of aortic aneurysm cause few to no symptoms, if the aorta ruptures, it could cause fatal internal bleeding if emergency surgery is not conducted quickly.