Levaquin Lawsuit Over Nerve Damage Alleges J&J Violated RICO Act

In failing to warn consumers about the risk of severe and permanent nerve damage from Levaquin side effects, a recently filed lawsuit alleges that Johnson & Johnson and a former commissioner of the FDA may have broken laws designed to fight organized crime.

In a complaint (PDF) filed earlier this week in the U.S. District Court for the District of Columbia, a group of six plaintiffs allege that the manufacturer of the popular antibiotic and Dr. Margaret Hamburg, former head of the FDA, violated federal Racketeer Influenced and Corrupt Organizations (RICO) act laws in the marketing of Levaquin.

Designed to combat organized crime, plaintiffs Terry Aston, John Fratti, Linda Martin, David Melvin, Ester Schulkin and Jennifer Wilcox claim that Johnson & Johnson and it’s Ortho-McNeil-Janssen Pharmaceuticals subsidiary intentionally failed to warn that Levaquin could cause a form of permanent nerve damage known as peripheral neuropathy, and orchestrated to defraud consumers, and that Hamburg and other regulators played a role in the activities.

In recent years, warnings for Levaquin were been updated to indicate that users may face a risk of long-term peripheral neuropathy from the antibiotics, even though prior information provided to consumers suggested that reports of nerve damage were rare and resolved once the medications were no longer used.

Plaintiffs seek $120 million in compensatory damages, as well as up to $750 million in punitive damages to punish the drug maker and deter similar conduct in the future. Such a massive amount is designed to actually affect the giant multinational pharmaceutical company, which had $74.3 billion in sales in 2014.

According to the Levaquin lawsuit, former FDA Commissioner Hamburg was married during her tenure to Peter Brown, who was an executive and co-CEO of Renaissance Technologies, a hedge fund with $342 million invested in Johnson & Johnson in 2011. It was the company’s third highest stock holding. Both Brown and Renaissance Technologies, as well as some of its other officers were also named as defendants in the lawsuit.

The plaintiffs claim that a number of the FDA’s actions while Hamburg was commissioner went against advice of advisors and reviewers, favoring companies that Renaissance Tecnologies was invested in, helping to raise the income of Hamburg’s husband from $10 million in 2008, to $125 million at its peak in 2011, since all Renaissance employees are paid based on performance of the company’s investments.

“Each and every Defendant acted in concert with one another in the District of Columbia and throughout the United States to violate RICO through a pattern of racketeering activity because of personal, financial gain, to fraudulently convey false and misleading information concerning the safety of Levaquin, and to conceal from the Plaintiffs, the public, physicians, and healthcare providers, the risks of serious adverse events, including mitochondrial toxicity, certain neuropsychiatric adverse events… and other chronic, degenerative illnesses directly associated with Levaquin,” according to the lawsuit.

Levaquin Peripheral Neuropathy Cases

The lawsuit over RICO violations will join other Levaquin injury lawsuits filed on behalf of former users diagnosed with peripheral neuropathy, which also allege that insufficient and misleading warnings were provided for consumers and the medical community.

Similar claims have also been raised in Avelox lawsuits and Cipro lawsuits, brought against makers of these other fluoroquinolone-based antibiotics, which are part of the same class of medications.

In the federal court system, nearly 350 cases involving peripheral neuropathy from any fluoroquinolone antibiotic are currently centralized for pretrial proceedings before U.S. District Judge John R. Tunheim in the District of Minnesota, as part of an MDL, or Multi-District Litigation.

As antibiotic nerve damage lawyers continue to review and file cases in the coming months and years, it is ultimately expected that several thousand cases will be involved in the litigation, each alleging that plaintiffs have been left with permanent peripheral neuropathy following use of the drugs.

The cases are being coordinated during discovery and for a series of early “bellwether” trials, which are designed to gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the cases.

Plaintiffs allege that the makers of Levaquin, Avelox and Cipro knew or should have known about the risk of permanent nerve damage for years, noting that the first indication of a possible link between long-term peripheral neuropathy and fluoroquinolone antibiotics came in a study published in 2001. If adequate warnings had been provided about the risk of permanent neuropathy problems, plaintiffs claim that they may have avoided painful and debilitating injuries.