In a trial in Minnesota that started today, Johnson & Johnson, the makers of the popular antibiotic drug Levaquin, was accused of hiding information about the risks that the drug posed.
The claimant in the case, 82-year-old John Schedin, says that after he started taking Levaquin, he ruptured the Achilles tendons in both of his feet. He decided to sue Johnson & Johnson as well as the company’s Ortho-McNeil-Janssen Pharmaceutical unit two years ago. At the time, both companies tried to act as if the drug didn’t carry that much risk for the injury — even though they had already heard about this adverse effect from Europe as far back as 2001.
“The decision they made was to add a single line to the 14-page package insert somewhere on page four or five,” says Schedin’s lawyer, Mikal Watts. “They did not tell the doctors that the use of Levaquin concomitant with corticosteroids will cause an Achilles tendon to rupture.”
This case is the first Levaquin one to go to trial against Johnson & Johnson even though there are currently at least 2,600 claims in the United States that say the same thing: Johnson & Johnson knew of the risks for Achilles tendon injuries related to Levaquin and it failed to warn the public properly.
The FDA insisted on proper warnings for Levaquin and other drugs in 2008, but the plaintiff says that the warnings should have come earlier and still are not good enough. The plaintiff’s legal team also says that Levaquin is Johnson & Johnson’s “blockbuster drug” because their marketing team downplayed the risks that the drug really posed.
“The warning has been in the label since December 1996,” argues defense lawyer John Dames. “It’s not hidden. It’s right there where you would expect it to be, in the warnings section.”
With this being the first trial against Levaquin, the results certainly will be interesting to see.