New Jersey to See Levaquin Trials Go Forward

Sometime this month or early next month, the first of the New Jersey Levaquin lawsuit trials will begin with a combination of claims brought by Bob Beare and Paul Gaffney. Many plaintiffs, like Beare and Gaffney allege that they were inadequately warned about known risks associated with taking Levaquin. Levaquin tendon side effects, including increased risk of tendon damage and tendon ruptures, particularly involving the Achilles tendon. Levaquin is part of a class of antibiotics known as fluoroquinolones.  Although many of the reported cases of tendon ruptures have been associated with the use of Levaquin, the side effects have also been seen with the use of other antibiotics which are part of this class.

The FDA in 2008 required Johnson & Johnson and makers of other drugs in the class to include a so-called black box or enhanced warning on the risk of tendon ruptures. The risk was higher in patients older than 60, those taking steroids, or who have had kidney, heart or lung transplants, the FDA said. Both Beare and Gaffney are over the age of 60 and suffered from the Levaquin tendon rupture before this warning was issued. In the first trial on Levaquin claims in the MDL, a Minneapolis jury in December awarded plaintiff John Schedin $700,000 in actual damages and $1.1 million in punitive damages. 

Causes of action filed against Ortho-McNeill Pharmaceuticals and Johnson & Johnson include: negligence, strict product liability for manufacturing and/or design defect and for failure to warn, breach of express and implied warranties for the design, manufacture, production, testing, study, inspection, labeling, marketing, advertising, sales, promotion, and distribution of the drug, fraud, unjust enrichment and violation of consumer protection laws. Although the drug contained a warning regarding the risks of tendon injury and rupture, including a warning about the drug's increased risks while using corticosteroids, the lawsuits argue that the labeling did not accurately portray the risks. They are also requiring a Medication Guide to be given to users when the prescription is filled. This requires the manufacturers to describe the risk and urges users to contact their doctor if they develop signs of a tendon rupture.