The federal court tapped to oversee hundreds of peripheral neuropathy lawsuits involving Levaquin, Cipro, and Avelox convened a conference on August 10th to address the status of the litigation.
According to Minutes issued by the U.S. District Court, District of Minnesota, there are 265 cases pending in the litigation that name Merck (Cipro) or Bayer (Avelox) as defendants. Approximately 180 of those lawsuits are Bayer-only cases and 85 are combination cases.
The Minutes indicate that plaintiffs have completed 7 depositions of Bayer or Merck employees, and have requested 12 additional Bayer employee depositions, most of which are scheduled for September. Plaintiffs also intend to depose Bayer Pharma AG (the German entity) employees in October.
The parties are also in the process of scheduling depositions for prescribing and treating physicians with regards to bellwether trials. The Court granted Plaintiffs’ motion and set a limit of one prescribing-physician deposition and four treating-physician depositions per bellwether case. This was done with the understanding that plaintiffs, would, in a reasonable period of time, identify any additional treating physicians whom they would likely call at trial. Defendants could depose those additional treating physicians without regard to the limit.
Finally, the parties noted that they had submitted a proposed order to establish a common benefit account, and confirmed that neither side opposed the order. As such, the Court entered an Order Establishing a Common Benefit Account on August 14th.
Fluoroquinolone antibiotics, including 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, despite their potential to cause permanent nerve damage and other serious side effects.
In December 2004, fluoroquinolone labels were first modified to list peripheral neuropathy as a potential side effect. The labels underwent further changes in August 2013, after the U.S. Food & Drug Administration (FDA) determined that the labeling did not adequately describe the “potential rapid onset and permanence” of the often-debilitating nerve condition. Among other things, statements that suggested peripheral neuropathy was a “rare” occurrence were deleted from the drugs’ labeling.
In May 2015, the FDA warned that patients suffering from certain uncomplicated infections should not be prescribed systemic fluoroquinolone antibiotics (those administered orally or via injection) 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 black box warning included in the prescribing information for all fluoroquinolone labels was updated to reflect the agency’s findings.