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The U.S. District Judge presiding over all federal product liability lawsuits involving nerve damage linked to Avelox and Cipro, indicates that a second group of bellwether cases will be selected for another round of trial dates.
There are currently more than 750 Avelox lawsuits, Cipro lawsuits and Levaquin lawsuits centralized before U.S. District Judge John R. Tunheim in the District of Minnesota, as part of a federal MDL or multidistrict litigation.
Each of the complaints raise similar allegations that the manufacturers of the fluoroquinolone-based antibiotics failed to adequately warn consumers and the medical community about the risk of developing a painful and debilitating condition, known as peripheral neuropathy, which may continue long after the medications are no longer used.
As part of the coordinated pretrial proceedings in the MDL, small groups of peripheral neuropathy lawsuits have been prepared for early trial dates, known as “bellwether” cases, since they are designed to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation. The first round of those bellwether trials is slated to begin in November.
In a pretrial order (PDF) issued on August 17, Judge Tunheim announced that a pool of 18 additional cases will comprise the second phase of bellwether trials, with eight cases to be selected by each side .
Plaintiffs and defendants will each select seven Avelox cases and two Cipro cases. From those, the court will select eight to move forward to go through the expert discovery process and serve as the phase II bellwether cases.
The selections must be from cases filed after April 21, 2016, and must not include claims where plaintiffs took more than one of the medications at issue.
No date was given on when the bellwether selections will be due.
Judge Tunheim previously indicated that the first Avelox bellwether trial will begin in November 2018, followed by a second Avelox case beginning in January 2019, a Cipro trial in March 2019, and two more Avelox trials in June and August 2019. It is expected that trial dates from the second round of bellwether selections will be set for late 2019 or early 2020, unless settlements are reached to resolve the litigation.
Fluoroquinolone Peripheral Neuropathy Litigation
The antibiotic 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 peripheral neuropathy, 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 Avelox, Cipro and Levaquin 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.
Given the risk of nerve damage and other injuries associated with the antibiotics, the FDA issued a new drug safety communication in May 2016, urging doctors not to prescribe fluoroquinolones for many common infections that are uncomplicated and have other available treatment options, indicating that the risks associated with the antibiotics outweigh the benefits.
The federal regulatory agency considered available information on the risk of peripheral neuropathy, tendon ruptures, retinal detachments and other health concerns linked to the drugs at that time.
More recently, research has also suggested that the same collagen degradation issues that cause the drugs to increase the risk of tendon ruptures and retinal detachment may impact the aorta.
As a result, a growing number of aortic aneurysm lawsuits and aortic dissection lawsuits are also being pursued against the drug makers, alleging that the painful and potentially life-threatening complication may have been avoided if proper warnings had been provided to users of the antibiotics.
If no settlement agreement is reached following any bellwether trials held in the MDL, the Court may begin remanding individual cases back to U.S. District Courts nationwide for individual trial dates in the future.