Johnson & Johnson’s Levaquin has been a courtroom headache for the drugmaker for years, and now, a new surge of lawsuits might have execs reaching for their Tylenol.
Plaintiffs in Pennsylvania and New Jersey are suing J&J, claiming that the company marketed Levaquin “aggressively” even though it knew the powerful antibiotic could cause peripheral neuropathy, a painful nerve condition.
The lawsuits come on the heels of stepped-up FDA warnings about serious risks, for Levaquin and the rest of the fluoroquinolone class.
Among the most recent lawsuits, filed in Pennsylvania federal court last week, plaintiff Michelin Rowell claims that taking Levaquin caused peripheral neuropathy that proved permanent. The suit alleges that Levaquin is a defective product, and that J&J committed fraud by failing to adequately warn doctors and consumers about the neuropathy risks earlier.
As of last week, more than a dozen lawsuits had been filed in New Jersey setting forth similar claims, with 10 more to come, the New Jersey Law Journal reported.
J&J had evidence of the risk as early as 1996, the Rowell lawsuit claims, and scientific data piled up in ensuing years. But J&J continued to market Levaquin as a first-line remedy for relatively minor infections, including sinus infections and urinary tract infections, the lawsuit claims.
Levaquin’s new labeling advises against using the drug in “uncomplicated” infections such as sinus infections and bronchitis. The same warnings apply to its fellow fluoroquinolones, including Bayer’s Cipro and Avelox. Lawyers in the New Jersey cases hope their suits will join a multi-district litigation effort in Minnesota, in which the neuropathy allegations also involve the Bayer drugs.
Levaquin made its market debut with a warning of “rare” instances of peripheral neuropathy in clinical trials, and said that the problem would clear up after the drug was discontinued. In 2013, Levaquin’s labeling was revised to remove “rare” from the cautionary language and updated to note that the neuropathy could begin very quickly after Levaquin therapy began--and that they might be irreversible.
The neuropathy lawsuits follow a previous wave devoted to Levaquin’s links to tendon injury. J&J faced 3,400 lawsuits over Levaquin’s links to tendon problems and settled many of those cases. In January, another group of patients sued, claiming that J&J deliberately mislabeled and misbranded Levaquin, playing down harmful side effects for its own financial gain.
J&J maintains that it has handled Levaquin and its risks correctly. "We … believe our actions regarding the medicine have been appropriate, responsible and in the best interests of patients," the company told FiercePharma earlier this year. "[W]e continually monitor the safety and efficacy of all our medicines and, in cooperation with the U.S. FDA and other health authorities, we update our product labels with new information so doctors and patients can make informed decisions.”
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