July 30, 2015 — Johnson & Johnson’s Janssen Pharmaceuticals unit has been hit with a lawsuit by a Texas woman who took the antibiotic Levaquin and developed peripheral neuropathy, a serious type of nerve damage.
The lawsuit (PDF) was filed this week in federal court in Pennsylvania (Case No. 3:02-at-06000) by Catherine Farmer, a resident of Plano, Texas.
The complaint alleges that in April 2006, Farmer used Levaquin for a sinus infection. The following month, she also received Levaquin intravenously when she was hospitalized for open heart surgery. When she was discharged from the hospital, she was prescribed a 7-day course of 500-mg Levaquin.
Soon after taking Levaquin intravenously and in pill form, Farmer says she developed peripheral neuropathy. She began experiencing constant pain, tingling and numbness in her arms and legs, dizziness, headaches, and other symptoms:
“In addition to the burning in her arms and legs and the all-over sensitivity to touch, Ms. Farmer currently experiences tingling in her scalp as if it is on fire. She also currently experiences facial numbness and burning.”
These symptoms worsened until 2008, when she was disabled and unable to work.
The lawsuit accuses drug-makers of failing to adequately warn about the risk of nerve damage. Although the side effect has been included on the label for Levaquin since 2004, Farmer claims it misleadingly indicated that nerve damage was rare and could be avoided by discontinuing Levaquin when symptoms appeared.
In August 2013, the FDA issued a Safety Communication after deciding the label on Levaquin was inadequate. The FDA warned that irreversible nerve damage could occur rapidly after taking Levaquin. The statement about “rare cases” of peripheral neuropathy was also removed.
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