Raritan, NJJohnson & Johnson (J&J) reportedly faces an $800 million Levaquin lawsuit, alleging the company hid vital information about side effects linked to the drug. Plaintiffs in the Levaquin antibiotic lawsuit allege Johnson & Johnson, and its subsidiary Janssen Pharmaceuticals, deliberately mislabeled Levaquin. In addition to J&J being named in the lawsuit, former FDA commissioner Margaret Hamberg is also listed and faces allegations of violations of the Racketeer Influenced and Corrupt Organizations (RICO) Act.
The lawsuit was filed by five plaintiffs, and seeks punitive damages of $750 million, plus $120 million for general damages. Specifically, the lawsuit alleges the defendants fraudulently conveyed false information concerning Levaquin’s safety, making it seem the drug was safer than it actually was for the purposes of financial gain. According to court documents, plaintiffs say they would not have taken Levaquin had they known about the risks and they would have been able to seek appropriate medical treatment once they suffered side effects if they had been made aware of the possible side effects.
“Defendants, each and every one of them, acting in concert jointly and severally, through the use of the interstate mail and wires, entered into and furthered a conspiracy to illegally and criminally influence the Commissioner of the Food & Drug Administration and the Food & Drug Administration to mislabel and misbrand a drug in order to make and sell an inherently dangerous drug by defrauding consumers…” the lawsuit alleges.
Among the side effects the lawsuit links to Levaquin are mitochondrial toxicity, certain neuropsychiatric adverse events, Carbapenem-Resistant Enterobacteriaceae, Fluoroquinolone-Associated Disability, and other chronic illnesses. The lawsuit contends that an FDA review of pediatric prescriptions for Levaquin were 100 percent off-label. Further, the lawsuit argues that in 2015 an FDA employee stated at an Advisory Committee Meeting that the agency has been aware of a potential link between Levaquin and “multi-system disability” but has not updated the label. That multi-system disability, according to court documents, is called “Fluoroquinolone-Associated Disability” (FQAD) and is linked to fluoroquinolone drugs, a class of drug that includes Levaquin and Cipro.
Plaintiffs allege that between 2009 and 2015, approximately 500 deaths occurred that were associated with the consumption of Levaquin, while there were approximately 8,000 reports of adverse events as reported to the FDA’s Adverse Event Reporting System.
The lawsuit is Aston, et al v. Johnson & Johnson et al, case number 1:16-cv-00086, in US District Court for the District of Columbia.
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