A whistleblower lawsuit has been filed against pharmaceutical companies that produce the widely-prescribed antibiotics Levaquin and Cipro by Dr. Charles Bennett, MD, PhD, MPP. Bennett is Director of the Center for Medication Safety and Efficacy at the University of South Carolina. 

The lawsuit claims fraud against the government by Johnson & Johnson, Bayer and Merck for making false statements and misbranding fluoroquinolones (FQs) for use in Medicaid, Medicare and other federal programs.  Bennett’s suit accuses the companies of misbranding, marketing, promoting and introducing these drugs through interstate commerce without warning on the labels that consuming them may result in Fluoroquinolone-Associated Disability (FQAD) and mitochondrial toxicity.

“This is significant action taken by a leading advocate of drug safety to call attention to the misdeeds of three pharmaceutical giants who have been causing unnecessary harm to patients for decades,” said Marilyn Beardsley Heise, author of Perilous Pills, Protecting Yourself from Fluoroquinolone Injury.  “Fluoroquinolones can cause disability or psychological impairment, sometimes for life.”

Since the 1990s, hundreds of millions of prescriptions have been written for fluoroquinolones to treat pneumonia, sinusitis, bronchitis, skin infections, prostatitis, urinary tract infections and kidney infections. It is estimated that at least 60% of these prescriptions were for Medicaid and Medicare patients.

The lawsuit argues that decisions by these companies are troubling because the drug makers were fully aware and on full notice of very serious adverse events based upon Dr. Bennett’s extensive research, the FDA’s MedWatch reporting system, other FQ research, FDA pharmacovigilance review reports, FDA advisory committee meeting discussions and two citizen petitions submitted to the FDA.  Bennett claims the companies ignored information in numerous reports, studies and hundreds of patient reports submitted to the FDA.

The legal action further argues that these companies ignored the science and continued to stand by Levaquin and Cipro as labeled. As a result, the suit claims that healthcare providers continued to prescribe Levaquin and Cipro without warning patients of the risks of FQAD and possible mitochondrial toxicity. In addition, they knowingly disregarded federal laws and FDA regulations about suppressing the harmful effects of Levaquin and Cipro.

The legal dispute claims that these companies fraudulently obtained billions of dollars from the federal government that unjustly enriched themselves at the expense of taxpayers and at risk of patient health. Further, by continuing this fraud, the companies exposed and continue to expose many individuals who could have been spared FQAD and mitochondrial toxicity if they had acted in accordance with the law and with FDA regulations.

Dr. Bennett is a noted advocate for drug safety and has spoken and written extensively about the risks of taking fluoroquinolones.