Antibiotic Peripheral Neuropathy Litigation Initial Status Conference Set For Dec 8
An initial status conference will be held early next month before the U.S. District Judge assigned to preside over all federal Levaquin lawsuits, Avelox lawsuits, and Cipro lawsuits, which allege that users of the popular antibiotics developed a severe form of nerve damage known as peripheral neuropathy.
In August, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings in the federal court system, centralizing the antibiotic peripheral neuropathy litigation before U.S. District Judge John R. Tunheim in the District of Minnesota to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the witnesses, parties and the courts.
There are already more than 200 cases pending in the recently established multidistrict litigation (MDL), and it is ultimately expected that several thousand complaints will be centralized before Judge Tunheim as peripheral neuropathy lawyers continue to review and file lawsuits for users of the antibiotics.
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According to a notice issued by the MDL court on November 6, an initial status conference will be held before Judge Tunheim on December 8, at which time the organizational structure for the antibiotic litigation will be discussed. It is expected that a group of plaintiffs lawyers will soon be appointed to serve in leadership roles during the litigation, conducting discovery and taking other actions during the pretrial proceedings that will benefit all plaintiffs.
As the number of cases continues to grow, Judge Tunheim will also likely establish a “bellwether” program, where a small group of representative cases will be prepared for early trial dates in the MDL.
While the outcomes of these cases will not be binding on other claims, they are designed to help the parties gauge how juries may respond to evidence and testimony that is likely to be repeated throughout a number of cases and potentially promote peripheral neuropathy settlements with the antibiotic manufacturers.
Risk of Peripheral Neuropathy with Levaquin, Avelox and Cipro
Each of the lawsuits over the antibiotics involve similar allegations, indicating that the manufacturers failed to adequately warn about the risk of long-term nerve damage users may face after taking Levaquin, Avelox, Cipro or other medications that are part of a class of antibiotics known as fluoroquinolones.
The peripheral neuropathy litigation has emerged since the FDA required new warnings for all fluoroquinolone-based antibiotics in August 2013.
While prior warnings provided with drugs indicated that some users experienced nerve damage, the drug makers suggested that the problems were rare and often resolved when the antibiotic was no longer used. The FDA required the makers of all fluoroquinolones to provide information about the long-term risk of peripheral neuropathy from the antibiotics, indicating problems may last for months or years after an individual stops taking the drug.
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.
Last week, at an FDA Advisory Committee hearing, advisors to the agency recommended that even more stringent warning labels be required about the potential side effects of the antibiotics, alerting the medical community to the risk of what FDA reviewers called Fluorquinolone-Associated Disability (FQAD), which drug experts at the agency say is a “constellation” of linked adverse side effects associated with the drugs.
The fluoroquinolone disability affects healthy individuals who take Levaquin or a similar antibiotic and then suffer peripheral neuropathy, tendon ruptures, heart problems , skin problems or other debilitating side effects as a result. These adverse events can lead to permanent disability and disruption of quality of life, FDA investigators warn.
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.
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