Court Overseeing Levaquin, Cipro and Avelox Lawsuits Amends Bellwether Trial Schedule

Published on October 19, 2017 by Sandy Liebhard

Peripheral neuropathy lawsuits involving Avelox, Cipro and Levaquin continue to move forward in the multidistrict litigation currently underway in the U.S. District Court, District of Minnesota.

According to an Order dated October 12th, the Court has amended the pretrial schedule for the first bellwether trials involving Cipro and Avelox to extend the non-expert fact discovery deadline until January 26, 2018.

“The parties have agreed that this extension of the non-expert fact discovery deadline is based on agreement that no additional Bayer & Merck Defendant fact witnesses — beyond those previously agreed to by the parties, or specifically set forth in this Order — may be deposed absent agreement of the parties or for good cause shown,” the Order states.

Case-specific discovery for Avelox-only and Cipro-only discovery cases is to be completed no later than January 19, 2018.

The parties are to submit briefs to the Court identifying the individual lawsuits they believe should serve as the Avelox Only and Cipro Only Bellwether Trial cases by February 2, 2018.

“The Court will select four (4) cases to serve as the Avelox Only Bellwether Trial Cases and one (1) Cipro Only Bellwether Trial cases by the date set for the February 2018 Case Management Conference (or by February 16, 2018 if no February 2018 conference is to be held),” the Order continues.

Bellwether trials involving Avelox lawsuits are scheduled to begin on:

  • November 5, 2018
  • January 8, 2019
  • June 10, 2019
  • August 5, 2019

A Cipro-only bellwether trial will begin on March 4, 2019.

Fluoroquinolones and Peripheral Neuropathy

Levaquin, Cipro and Avelox are indicated to treat pneumonia and other serious bacterial infections. However, these drugs are also frequently prescribed for more routine illnesses, including ear infections and urinary tract infections.

Plaintiffs involved in this litigation claim that defendants failed to adequately warn doctors and patients about the potential for fluoroquinolone antibiotics to cause peripheral neuropathy, noting that the association between the drugs and the often-debilitating nerve disorder was first flagged in a study published in 2001. Plaintiffs further contend that they could have avoided their injuries had they been furnished with adequate notice of this risk.

The labels for fluoroquinolone antibiotics were initially updated to note peripheral neuropathy as a potential side effect in December 2004. The U.S. Food & Drug Administration (FDA) ordered further modifications in August 2013, after further review determined that the prescribing information did not adequately describe the “potential rapid onset and permanence” of peripheral neuropathy symptoms. Among other things, wording that characterized peripheral neuropathy as a “rare” occurrence was removed.

In May 2016, the FDA warned that systemic fluoroquinolones (those administered orally or via injection) should not be used to treat patients suffering from certain uncomplicated infections when other treatment options are available. The warning followed an agency review which linked antibiotics like Levaquin, Cipro and Avelox to permanent and potentially disabling complications affecting the tendons, muscles, joints, nerves, and central nervous system.

The FDA also ordered fluoroquinolone manufacturers to highlight this new safety information in the Black Box Warning on the drugs’ labels. A Black Box Warning is the strongest possible safety warning.

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