FDA Reports Continue to Plague Levaquin

By July 9, 2012 July 16th, 2019 Uncategorized

When the popular antibiotic medication Levaquin was first approved by the FDA in 1996, the drug was met with much excitement. For a time, Levaquin was the most popular antibiotic used to treat severe bacterial infections. This started to change once the drug was found to cause tendon ruptures and rotator cuff tears.

Manufactured by Johnson & Johnson, Levaquin was the go-to drug until the FDA issued a public health advisory over the tendon rupture side effects in 2008. At that time, the FDA issued a black box warning against Levaquin as a response to what consumer watchdog group Public Citizen called “hundreds of reported cases of tendon tears.” Indeed, between 1996 and 2008, the FDA had gotten 10,166 adverse reports against Levaquin’s side effects which included the tendon ruptures.

In the warning, it was found that Levaquin was more dangerous to patients older than 60, those taking corticosteroids and those who suffered from heart, lung or kidney transplants. Unfortunately, these side effects and special warnings did not come fast enough for many patients, many of which have now filed lawsuits after they suffered from tendon ruptures and rotator cuff tears. As of June 11, 2012, the MDL in the U.S. District of Minnesota has already been assigned 1,787 lawsuits over tendon ruptures and other injuries.

At least one Levaquin lawsuit resulted in a $1.8 million award for plaintiff John Schedin; that award was upheld on appeal. Schedin also developed tendon ruptures after taking Levaquin, and was older than 65 at the time of the Levaquin use. Like many plaintiffs, Schedin’s lawsuit claimed that the manufacturers of the drug failed to properly warn him and healthcare professionals of the dangers linked to Levaquin before he used it. Schedin’s award may have gone a long way toward the courts holding the manufacturers liable for his and future plaintiffs’ injuries.