Nearly 400 peripheral lawsuits filed against the manufacturers of Levaquin, Cipro and Avelox continue to move forward in the federal multidistrict litigation in U.S. District Court in Minnesota. The proceeding convened its most recently monthly Status Conference on May 18th, when it was reported that 383 cases were pending in the federal litigation.
An additional 39 claims make similar allegations about the potential for fluoroquinolone antibiotics to cause peripheral neuropathy (disease or dysfunction of one or more peripheral nerves, typically causing numbness or weakness) and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.
Minutes from the federal conference indicate that U.S. District Judge John R. Tunheim overseeing those cases would be interested in coordinating with the multidistrict litigation. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)
The Plaintiffs have submitted a proposed bellwether case protocol to the Court. The next status conference is set for July 13 or July 28, 2016.
Fluoroquinolone Side Effects
Fluoroquinolone antibiotics, including Levaquin, Cipro and Avelox, are indicated to treat pneumonia, sexually transmitted diseases, E. coli, staph and other serious bacterial infections. Plaintiffs allege that the manufacturers failed to provide doctors and patients with adequate warnings about their potential to cause serious nerve damage, including permanent neuropathy.
A mention of these complications was added to the drugs’ labeling in 2004. However, the U.S. Food & Drug Administration (FDA) ordered their manufacturers to strengthen the labels in 2013 to better reflect the rapid onset of symptoms, as well as the potential for permanence. (In Re: Fluoroquinolone Products Liability Litigation – MDL No. 2642)
On May 12, 2016, the FDA required labeling changes for fluoroquinolones, including an updated boxed warning, stating that the serious side effects associated with the antibiotics generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones are associated with disabling and potentially permanent, serious side effects that can occur together. These side effect can involve the tendons, muscles, joints, nerves and central nervous system. As a result, the FDA is also requiring label changes for all systemic fluoroquinolone antibacterial drugs to reflect this new safety information.