Levaquin Aortic Dissection Lawsuit Filed Over Controversial Antibiotic

According to a product liability lawsuit recently filed by a man who claims he suffered an aortic dissection from Levaquin, the makers of the popular antibiotic have known that their fluoroquinolone-based medication increases the risk of serious collagen disorders, yet withheld information from consumers and the medical community.

The complaint (PDF) was filed by Benn Prybutok in the U.S. District Court for the Southern District of New York on September 30, claiming that a lack of adequate warnings provided by Johnson & Johnson and its Janssen subsidiary has placed patients’ lives at serious risk, given the importance of early detection for aortic problems.

Prybutok indicates that side effects of Levaquin taken in May 2007 caused a break down of collagen tissue inside his body, resulting in an aortic dissection that required surgical repair.

Aortic dissections pose a serious and potentially life-threatening health risk, involving a tear inside of the aorta that causes blood to low between the layers, forcing them apart. It is similar to an aortic aneurysm, which occurs when the walls of the artery weaken and an abnormal bulge develops. The conditions are associated with severe chest or back pain, which can quickly lead to death or severe, long-term injury.

The lawsuit filed by Prybutok indicates that the drug makers should have known for years that Levaquin increases the risk of aortic dissections and aortic aneurysms due to the drug’s known link to tendon ruptures and other side effects involving a breaking down of connective tissues. However, either the company failed to investigate the potential risks or failed to inform the medical community and patients about those risks, the complaint states.

“The Defendant’s failure to investigate or study the potential association between Levaquin and aortic rupture and dissection was not due to lack of awareness,” the lawsuit states. “Defendants have for years had in their possession adverse event reports denoting patients who had received levofloxacin and suffered aortic aneurysm ruptures, aortic dissections and/or aortic ruptures following therapy.”

In October 2015, an independent study published in the medical journal JAMA Internal Medicine found that current use of Levaquin, Avelox or other similar fluoroquinolone antibiotics was associated with a two-fold increased risk of suffering an aortic aneurysm or dissection injury.

Researchers suggested that they set out to examine the risk based on the known association between fluoroquinolones and collagen degradation, which has previously resulted in warnings about the risk of tendon ruptures, retinal detachments and other problems with Levaquin, Avelox and other similar drugs

Prybutok’s case comes as a growing number of individuals nationwide are investigating similar Levaquin lawsuits or Avelox lawsuits, seeking compensation for injuries they claim could have been avoided by different treatment alternatives or more closely monitoring for aortic injuries.

In May, the FDA issued a drug safety communication about the risks associated with the antibiotics, indicating that “disabling and potentially serious side effects” associated with fluoroquinolones outweigh any benefits provided in using the drugs to treat uncomplicated infections, requiring the drug makers to add new warnings for doctors to indicate that the drugs should not be used to treat such infections, unless there are no alternative treatments available.

That warning was based on an FDA evaluation into other known risks associated with the antibiotics, which included data on tendon ruptures, bone fractures, a form of permanent nerve damage known as peripheral neuropathy and other side effects, according to the agency.

Prybutok presents claims of strict liability, failure to warn, negligence, breach of warranty, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment and violation of new York Consumer Protection laws.