Minneapolis Jury Awards First Damages For J&J Blockbuster Drug Levaquin

MINNEAPOLIS, MN – Today a Minneapolis jury awarded $1,815,000 for compensatory and punitive damages to John Schedin, an 82-year-old Edina man who ruptured both of his Achilles tendons while on the popular Johnson & Johnson (NYSE: JNJ ) antibiotic, Levaquin. The drug, first approved by the FDA in December 1996, is prescribed to prevent infection by stopping the reproduction of bacteria. Reports suggest an increased risk of tendon damage and possible tendon ruptures when used in combination with steroid medications, especially in the elderly. In 2005, Schedin was prescribed Levaquin, along with a steroid, for a respiratory infection. At the time only one line buried in the 14-page medication guide mentioned a risk of tendon rupture when used together with steroids. In 2008, the FDA determined that warning was inadequate. After only 3 days on the antibiotic, Schedin experienced debilitating bilateral ruptures in his Achilles sidelining him from his once active life. In July 2008, the FDA required that a “black box” warning be added about the side effects of Levaquin and other similar antibiotics. This type of warning is the strongest warning that can be placed on a prescription medication before it is withdrawn from the market.

The Minneapolis trial began on November 15, 2010, in front of Judge John Tunheim. Attorneys for the plaintiff told the jury that Johnson & Johnson was aware of the risk of Levaquin causing tendon ruptures through adverse event reports from its distribution in Europe. However, the company allegedly suppressed data showing Levaquin caused more ruptures than other antibiotics in its class and then helped to engineer a study that concluded Levaquin caused no more tendon ruptures than other similar antibiotics.

The jury of 8 men and 4 women determined that the drug did in fact contain an inadequate warning and, in turn, caused the plaintiff to suffer a serious injury. According to Zimmerman Reed attorney for the plaintiff, Ron Goldser, “It took a jury of ordinary citizens to hold the drug maker accountable. Sometimes corporations will stand up and take responsibility for the injuries they cause – but if they won’t, the jury system is there to hold accountable both individuals and corporate citizens alike.” There are more than 2,600 similar lawsuits pending nationwide against Johnson & Johnson over tendon damage caused by Levaquin.