Quoted from http://www.bloomberg.com/news/2010-11-15/johnson-johnson-hid-risks-of-antibiotic-levaquin-lawyer-says-in-trial.html
Johnson & Johnson Hid Antibiotic’s Risk, Lawyer Says
By Margaret Cronin Fisk and Beth Hawkins - Nov 15, 2010 7:58 PM ET
Johnson & Johnson knew its antibiotic Levaquin increased the risk of tendon damage and failed to properly warn patients or doctors, a lawyer said today at the start of a trial in Minnesota.
John Schedin, 82, who said he ruptured the Achilles tendons in both feet after taking the drug, sued the company and its Ortho-McNeil-Janssen Pharmaceutical unit in 2008. The companies downplayed the risks of Levaquin even after receiving adverse reports from Europe in 2001, Schedin’s lawyer, Mikal Watts, said in his opening statement at trial today.
“The decision they made was to add a single line to the 14-page package insert somewhere on page four or five,” Watts told the Minneapolis jury. “They did not tell the doctors that the use of Levaquin concomitant with corticosteroids will cause an Achilles tendon to rupture.”
Schedin’s case is the first trial on more than 2,600 claims in U.S. courts against Johnson & Johnson that Levaquin caused tendon damage in patients taking the drug and the company failed to adequately disclose the risk. The U.S. Food and Drug Administration in 2008 required an upgraded warning on tendon damage posed by Levaquin and similar drugs.
The plaintiffs claim the warning should have been enhanced earlier and remains inadequate. They also claim Johnson & Johnson and Ortho-McNeil-Janssen boosted sales by downplaying risks.