Patients sue J&J for $800m for ‘hiding antibiotic side effects’
pharmafile | January 22, 2016 | News story | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | FDA, Janssen, Johnson and Johnson, Levaquin, Margaret Hamburg, lawsuit, levofloxacin
Six users of Johnson & Johnson’s antibiotic Levaquin are to sue the company for up to $870 million, claiming the company deliberately hid serious side effects of the product.
The five claim in a suit that J&J and its pharma division Janssen mislabelled and misbranded Levaquin (levofloxacin).
Levaquin belongs to a class of potent antibiotics called fluoroquinolones – generally used to treat skin, sinuses, kidneys, bladder and prostate infections. Late last year, an FDA committee warned the public of potentially serious adverse effects relating to fluoroquinolones, recommending label changes to reflect an increased risk of what it called a ‘constellation of symptoms’, which it termed Fluoroquinolone-Associated Disability, or FQAD. The panel said the risk of FQAD symptoms – including musculoskeletal issues, peripheral neuropathy, cardiovascular and skin problems –was greatest in patients treated for bronchitis, sinusitis and urinary tract infections.
The lawsuit is considered unusual as it asserts J&J violated the federal Racketeer Influenced Corrupt Organizations Act (RICO), which is normally used to prosecute organised crime.
A spokesperson for Janssen responded, saying that based on its scientific knowledge, the company believes its actions regarding the medicine were ‘appropriate’.
However, J&J and Janssen are not the only subjects being sued by the plaintiffs. Other defendants listed in the suit include former FDA commissioner Margaret Hamburg and her husband Peter Brown. Hamburg left the role early last year, prior to the panel warnings, and the plaintiffs say the misbranding of the drug ‘increased the combined wealth’ of her and Brown.
The suit reads the defendants “entered into and furthered a conspiracy to illegally and criminally influence the commissioner of the Food and Drug Administration, and the Food and Drug Administration to mislabel and misbrand a drug in order to make and sell an inherently dangerous drug by defrauding consumers such as Plaintiffs in order to acquire and reap financial gain.”
“These concerted efforts resulted in significant harm and/or death to consumers of Levaquin, including plaintiffs,” the suit adds.
The plaintiffs are seeking over $120 million in compensatory damages and more than $750 million in punitive damages from the defendants – figures they say will highlight “the seriousness of their egregious conduct and to deter similar conduct in the future.”
This is the latest lawsuit of thousands relating to Levaquin in recent years. One case resulted in J&J paying out $1.8 million, but in 2012, the healthcare giant settled close to 1,000 suits for an undisclosed sum.
Joel Levy
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