A Qui Tam whistleblower lawsuit has been filed against pharmaceutical giants Johnson & Johnson, Bayer and Merck by Charles Bennett, M.D., Ph.D., M.P.P., SmartState Chair, Director of the Center for Medication Safety and Efficacy at the University of South Carolina. The lawsuit was recently unsealed in the United States District Court for the Southern District of New Jersey district court.
The Qui Tam lawsuit filed against Johnson & Johnson, Bayer and Merck claims fraud against Medicaid, Medicare, and other government programs related to a class of drugs manufactured and marketed by these drug companies, referred to as fluoroquinolone (FQ) antibiotics. FQ antibiotics manufactured and marketed by these drug companies include Johnson’s Levaquin and Bayer and Merck’s Cipro. Johnson & Johnson manufactured Levaquin from 1997 to 2018; Bayer and/or Merck have manufactured Cipro since 1988.
The Qui Tam accuses Johnson & Johnson, Bayer, and Merck of making false statements and misbranding their FQ antibiotics which resulted in fraudulent claims to be filed against the United States government for Medicaid and Medicare patients and for other government programs in violations of 31 U.S. Code § 3729-33 the False Claims Act.
Since the 1990s, hundreds of millions of prescriptions have been written for FQ antibiotics used 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, in part, accuses Johnson & Johnson, Bayer and Merck of committing fraud by misbranding, marketing, promoting, and introducing through interstate commerce, their FQ antibiotics without any warning on the drug labels that consuming these antibiotics may result in Fluoroquinolone-associated Disability (“FQAD”) and mitochondrial toxicity.
The Qui Tam argues that decisions by Johnson & Johnson, Bayer, and Merck to misbrand Levaquin and Cipro are particularly troubling because the drug makers are fully aware and are on full notice of the very serious adverse events based on Dr. Bennett’s extensive research; Levaquin’s and Cipro’s FDA Adverse Events Reporting System (FAERS) reports; other FQ research; FDA pharmacovigilance review reports; FDA advisory committee meeting discussions; and two Citizen Petitions submitted to the FDA by Dr. Bennett.
Specifically, the Qui Tam charges that Johnson & Johnson, Bayer, and Merck ignored information contained in the Citizen Petitions Dr. Bennett filed in June 2014 and September 2014; an April 17, 2013 FDA pharmacovigilance review “Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology,” with the subject line, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure;” an FDA report presented at the November 5, 2015 FDA Joint Meeting of the Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee; a January 31, 2016 study authored by Dr. Bennett and others which replicated certain adverse reactions using mice treated with Cipro; and hundreds of patient reports submitted to the FDA.
The lawsuit further argues that Johnson & Johnson, Bayer, and Merck ignored the science and continued to stand by Levaquin and Cipro as labeled. As a result, the Qui Tam claims that healthcare providers continued to prescribe Levaquin and Cipro without warning patients—the majority of whom were Medicaid, Medicare, or other Government program beneficiaries—of the risks of FQAD and of the risks of possible mitochondrial toxicity.
The Qui Tam charges that the lack of adequate warnings resulted in the government healthcare programs and other government programs providing reimbursements and making payments that should not have been provided or made.
Johnson & Johnson, Bayer, and Merck knowingly disregarded federal laws and FDA regulations relating to prohibitions on suppressing the harmful effects of the fluoroquinolone antibiotics Levaquin and Cipro, according to the lawsuit.
The Qui Tam claims that Johnson & Johnson, Bayer, and Merck fraudulently obtained billions of dollars from the federal government, thereby unjustly enriching themselves at the expense of taxpayers and at the risk of patient health.
Moreover, the lawsuit claims that by continuing with its fraudulent, misbranded labeling and by neglecting their own duty, Johnson & Johnson, Bayer, and Merck 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.