Hundreds of antibiotic peripheral neuropathy lawsuits filed against the manufacturers of Cipro, Avelox and Levaquin continue to move forward in the U.S. District Court, District of Minnesota. According to an Order dated July 29th, the Court has approved a Defendant Fact Sheet, which is to be utilized by all defendants involved in the multidistrict litigation.
A Defendant Fact Sheet is used in large, centralized litigations to standardize discovery, and generally takes the place of written interrogatories. The Court overseeing the federal fluoroquinolone litigation approved a similar Plaintiff’s’ Fact Sheet in April.
According to the July 29th Order, every Defendant in each individual lawsuit filed in or transferred to the federal litigation is required to compete and execute a Defendants Fact Sheet within 60 days of receipt of a substantially completed and verified Plaintiff’s Fact Sheet. The completed and executed Defendants’ Fact Sheet is to be served on Plaintiffs’ counsel named in the lawsuit. The Defendant must also produce to Plaintiffs’ Counsel all responsive, non-privileged documents in their custody that are requested by the Defendant’s Fact Sheet.
Alternatively, the Defendant must provide written certification that it has no relevant information or responsive materials required by the Defendants’ Fact Sheet.
At least 396 Levaquin lawsuits and other peripheral neuropathy cases involving Cipro and Avelox have been filed in the centralized fluoroquinolone litigation now underway in the District of Minnesota. Plaintiffs claim that the drugs’ manufacturers failed to provide doctors and patients with adequate warnings regarding the potential for the antibiotics to cause serious nerve damage. They further claim that the companies were aware of this possible side effect as early as the 1990s, yet concealed this information from the public and medical community.
Levaquin, Cipro and Avelox are all approved to treat serious bacterial infections, such as pneumonia. In 2004, mention of peripheral neuropathy was added to the prescribing information of all fluoroquinolone antibiotics. However, plaintiffs assert that the wording suggested the complication was rare and would likely resolve once a patient ceased antibiotic treatment. In 2013, the U.S. Food & Drug Administration (FDA) ordered that label information pertaining to peripheral neuropathy be revised to better reflect the possible rapid onset of symptoms and the potential for permanent nerve damage.
This past May, the FDA ordered all fluoroquinolone manufacturers to update the antibiotics’ boxed warning to state that the risks posed by the drugs outweigh their benefits for patients with certain uncomplicated infections when other treatment options are available. The agency acted after a review confirmed that fluoroquinolone antibiotics are associated with a number of serious and potentially permanent side effects, including those involving the tendons, muscles, joints, nerves and central nervous system.