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.
“Their marketing people were so successful, it became a blockbuster drug,” Watts said. Schedin is seeking unspecified compensatory and punitive damages.
The companies deny any failure to warn or that Levaquin caused Schedin’s tendon ruptures.
“The warning has been in the label since December 1996,” when the drug first came on the market, defense attorney John Dames said in his opening statement. “It’s not hidden. It’s right there where you would expect it to be, in the warnings section.”
The drug has been prescribed more than 430 million times worldwide, company lawyers said in a filing today. Levaquin’s sales for the last nine months were $957 million.
“Levaquin is probably one of the best antibiotics ever made or distributed in this country or in the world,” Dames said. “You get better, faster.”
The FDA in 2008 required Johnson & Johnson and makers of other drugs in the class of antibiotics called fluoriquinolones to include a “black box” or enhanced warning on the risk of tendon ruptures. The risk was higher in patients older than 60, those taking steroids, or who have had kidney, heart or lung transplants, the FDA said.
Schedin, then 76, was prescribed Levaquin and a steroid for an upper respiratory infection in 2005, according to his complaint.
‘Vigorous and Active’
“Prior to his Levaquin-induced bilateral Achilles tendon rupture, he was vigorous and active for his age,” his lawyers said in a Nov. 14 filing. “He has never fully recovered and is now severely restricted in his activities.”
His doctor would have prescribed another antibiotic if he knew “about the risks associated with Levaquin, especially when taken together with steroids.” Schedin said in court papers.
Schedin’s doctor “testified that he was aware of this risk of tendon rupture when he prescribed Levaquin,” defense lawyers said in court papers today.
Johnson & Johnson added a warning about the steroid effect to the Levaquin label in 2001, Dames, the defense lawyer, said today. The company changed the label on “its own initiative, not at the prodding of the FDA or other regulatory agencies,” he said.
Schedin’s lawyers claim the 2001 label was inadequate and remains so, despite the 2008 warning change. “Even today, defendants still have not warned doctors about the increased risk of Levaquin concerning tendon disorders,” compared with other drugs in its class, the lawyers said in the Nov. 14 filing.
Ortho-McNeil “properly warned of the risks of tendon injury” and “acted responsibly by providing appropriate and timely information about Levaquin,” company spokesman Michael Heinley said in an e-mail today.
The lawsuit is Schedin v. Johnson & Johnson, 08-cv-05743, combined for trial in In Re: Levaquin Products Liability Litigation, 08-md-01943, U.S. District Court, District of Minnesota (Minneapolis).