A federal panel of judges will decide after a July 30 hearing in San Francisco whether to centralize before a single judge numerous federal cases centered on a new basis for litigation against the maker of the antibiotic Levaquin. The U.S. Judicial Panel on Multidistrict Litigation grouped together Levaquin lawsuits in this manner in 2008 at a Minnesota trial court in regard to tendon injuries. The new reason that these actions may be centralized pertains to the drug's alleged nerve damage risk.
As of July 15, only 70 Levaquin lawsuits out of more than 2,000 put before U.S. District Court for the District of Minnesota have yet to be adjudicated. Johnson & Johnson is one of the defendants.
In the Minnesota cases, according to court documents, "Plaintiffs have been prescribed Levaquin, and allege that it causes tendons to rupture. They claim that defendants' warnings about this alleged side effect were inadequate."
In the fresh round of litigation, plaintiffs in 24 cases request that their Levaquin lawsuits and those of future alleged victims be centralized before U.S. District Court for the Southern District of Illinois for expeditious coordination of discovery and other pretrial proceedings. In these new cases, plaintiffs allege that there is a connection between their long-term peripheral neuropathy diagnosis and the use of the antibiotic. The proposed multidistrict litigation court would oversee actions involving Levaquin (levofloxacin) and other drugs in its fluoroquinolone category, a class that includes:
- Ciprofloxacin (Cipro)
- Moxifloxacin (Avelox)
- Norfloxacin (Noroxin)
- Ofloxacin (Floxin)
- Gemifloxacin (Factive)
A Tennessee woman is among those whose cases may be moved from California to Illinois. A long-term peripheral neuropathy sufferer, the plaintiff filed suit in December 2014.
The U.S. Food and Drug Administration approved Levaquin in 1996. The Tennessee plaintiff was diagnosed with peripheral neuropathy after she began taking Levaquin as directed in December 2013. The plaintiff's petition points out that for years Levaquin's label made it seem as if a peripheral neuropathy diagnosis was "rare" and that the condition could have been avoided by discontinuing the use of the drug. Nevertheless, as the petition reads, "The truth, however, is that the onset of irreversible peripheral neuropathy is often rapid and discontinuation of the drug will not ensure that the peripheral neuropathy is reversible."
Moreover, according to the plaintiff, even when the label was adjusted in 2013 to reflect the risk of irreversible peripheral neuropathy, "the language was in no way highlighted for the benefit of prescribing physicians and patients," and the defendants never sent physicians a Dear Doctor letter explaining the important risk update.
The FDA in August 2013 directed a label change on fluoroquinolone drugs to include the possible permanence of peripheral neuropathy. It took time for the labels to be actually updated, and the defendant started taking Levaquin in December 2013.
The FDA wrote Aug. 15, 2013, "The U.S. Food and Drug Administration has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent."
There was scientific evidence linking the drug to enduring PN in 2001. It's not just the risk of complications that matters; it's the persistence of the condition even when someone does not take the drug anymore. For instance, a paper by Jay S. Cohen published in 2001 made the point, the plaintiff claimed.
As the petition reads, the Cohen paper "revealed that adverse events reported by forty-five patients suggested a possible association between fluoroquinolones and long-term peripheral nervous system damage. The study noted in particular the presence of severe and/or persistent nerve problems. Over one-half of the patients surveyed said their symptoms lasted for more than a year, and eighty percent characterized their symptoms as severe. The Cohen paper recommended further investigation of the association between fluoroquinolones and peripheral neuropathy."
The author ended the piece be writing that if fluoroquinolone drugs were linked to adverse events as severe and as enduring as these, then "physicians need to be informed and warnings might be considered for these drugs' product information." Again, that was 2001, a dozen years before the label, at the FDA's behest, was actually updated to reflect the lingering nature of apparent fluoroquinolone-induced peripheral neuropathy.
Levaquin users - actually the users of any fluoroquinolone antibiotic - who have suffered from peripheral neuropathy since using the drug, may want to consult an attorney to determine whether there is an entitlement to compensation for medical expenses and for other losses. This may be an appropriate move particularly if peripheral neuropathy has lingered after the discontinuance of the drug.