An Illinois federal judge has decided that Janssen Pharmaceuticals may be held liable for injuries allegedly associated with a generic version of its antibiotic Levaquin, allowing a peripheral neuropathy lawsuit naming the company as a defendant to go forward.
According to court records, Plaintiff Tracy Garner was prescribed a generic brand of levofloxacin in December 2014 to treat a urinary tract infection. The medication was manufactured by Zydus Pharmaceuticals.
Garner claims that her use of the fluoroquinolone antibiotic caused her to develop a number of serious side effects, including:
Garner filed suit against Johnson & Johnson, its Janssen Pharmaceuticals subsidiary and Zydus in December 2016, accusing the Defendants of ignoring evidence of levofloxacin side effects and failing to warn doctors and patients about these risks.
All three defendants filed motions seeking to dismiss Garner’s lawsuit. Johnson & Johnson and Janssen argued that they were not liable for her injuries, as they did not manufacture the medication Garner had been prescribed.
Zydus asserted that Garner’s claims were federally preempted by the 2011 U.S. Supreme Court decision in Pliva vs Messing, which barred plaintiffs from pursuing state failure-to-warn claims against generic drug makers because those companies have no control over the contents of their products’ safety labels.
In a decision written in September but only recently publicized, Judge Sara Darrow of the U.S. District Court, Central District of Illinois, agreed that Garner’s case against Zydus was preempted and dismissed those claims.
However, Garner will be allowed to pursue her allegations against Johnson & Johnson and Janssen, with Judge Darrow pointing out that doctors and patients rely on the brand-name drug labeling even when they are prescribing or using a generic version.
“Janssen, a brand-name manufacturer, is surely not blindsided to find out that the equivalent of its Levaquin labels was imposed on generic versions of levofloxacin and that doctors and patients would rely on the labeling composed by Janssen even when using the generic drug,” the judge explained. “Further, it is a common practice, and therefore foreseeable, for a doctor to prescribe a name brand drug and the pharmacy to fill it with the generic version. The likelihood that Janssen’s alleged design or labeling negligence would cause injury is high.”
Levaquin and other fluoroquinolone antibiotics are prescribed to more than 22 million people annually to treat pneumonia and other bacterial infections. While they are widely used, the drugs have been the subject of numerous safety controversies.
In August 2013, for example, the FDA ordered the manufacturers of oral and injectable fluoroquinolones to update the labels’ “Warning and Precautions” section to note a possible link to peripheral neuropathy. While information about the often-debilitating nerve disorder had been listed on all fluoroquinolone labels since 2004, the agency determined that the prescribing information did not reflect the possible rapid onset of the condition, or the potential for permanent nerve damage.
The fluoroquinolone black box warning was updated in May 2016 to caution against their use in patients suffering from sinusitis, bronchitis and uncomplicated urinary tract infections when other options are available. The warning followed an FDA review that suggested fluoroquinolones could cause multiple and permanent side effects involving the tendons, muscles, joints, nerves and central nervous system.
The black box warning was originally added to fluoroquinolone labels in 2008, after the drugs were linked to serious tendon injuries, including ruptures of the Achilles tendons.
Hundreds of plaintiffs are currently pursuing peripheral neuropathy lawsuits against the manufacturers of Levaquin, as well as two other fluoroquinolone antibiotics, Cipro and Avelox. The majority of these claims have been centralized in a federal litigation underway in the U.S. District Court, District of Minnesota.
In November 2012, Johnson & Johnson and Janssen agreed to settle more than 800 Levaquin lawsuits over tendon injuries.
Other recent Levaquin lawsuits have involved accusations that the medication can cause serious aortic injuries, including aortic dissection and aneurysm.