A federal jury awarded an Edina man more than $1.7 million in damages Wednesday after finding that drug giant Johnson & Johnson failed to adequately warn patients that its popular antibiotic Levaquin may cause tendon damage.
The Minneapolis jury awarded $1.1 million in punitive damages and $630,000 in compensatory damages to 82-year-old John Schedin, who ruptured or partially ruptured both Achilles tendons after taking Levaquin and a steroid five years ago for bronchitis. At the time, neither Schedin nor his physician was aware of the risks associated with the drug combination.
The case in U.S. District Court in Minneapolis was the first to go to trial of thousands nationwide that Levaquin patients have filed with claims of tendon injuries. The blockbuster drug is commonly prescribed for various infections -- more than 430 million prescriptions have been written worldwide.
The verdict from a jury of eight men and four women came after nearly three weeks of often riveting, but sometimes highly technical testimony that explored the intricacies of epidemiology, clinical studies and complicated drug regulations.
Schedin, a retired salesman who said he was an active golfer and mall-walker until his injury, filed the suit against New Jersey-based Johnson & Johnson and its Ortho-McNeil-Janssen Pharmaceuticals unit in 2008, claiming they failed to warn doctors and patients of Levaquin's association with tendon damage.
J&J's lawyers repeatedly denied the claim, saying a warning has been on the drug's label since 1997 when Levaquin was launched in the United States.
Juror Zach Rawson of Rochester said Wednesday: "We talked a lot about the responsibility the company had to the general public as far as safety goes. We felt that they didn't warn adequately, that they didn't use enough means of warning the public, especially the doctors."
In 2008, the Food and Drug Administration required J&J and makers of similar drugs to include a serious "black box" warning on packaging regarding possible tendon damage.
The risk is higher in patients over 60, and in those taking steroids -- as was Schedin, who was 76 when he took both drugs for a lingering chest infection. Within three days, he said, he felt a stabbing pain in his ankles, an injury later confirmed to be Achilles-related.
More than 2,600 similar claims have been filed against Johnson & Johnson/Ortho-McNeil in state and federal courts nationwide, several hundred of which have been consolidated in Minneapolis federal court under Judge John Tunheim.
Ortho-McNeil spokesman Michael Heinley said the company plans to appeal. "The verdict and the amount of the compensatory and punitive damages are at odds with the evidence presented at trial," he said, noting the company "properly informed [the public] of the benefits and risks associated with the use of Levaquin, and the company acted responsibly by providing appropriate and timely information about Levaquin."
Going forward, the company said it will "defend these cases on an individual basis."
Ron Goldser, from the Minneapolis firm Zimmerman Reed, who served as co-lead counsel for Schedin, said his client "is very pleased because he feels his decision to come forward has been vindicated. He came forward so this doesn't happen to others. It was never about the money for him."
Bloomberg News contributed to this report.
Janet Moore • 612-673-7752