A Los Angeles judge has refused to dismiss on federal pre-emption ground a product-liability case against Medtronic Inc. over the use of its Infuse bone graft device during spinal surgeries.
Medtronic and its subsidiary, Medtronic Sofamor Danek USA Inc., had moved for dismissal on summary judgment, arguing the claims that it marketed the device for uses not approved by the U.S. Food and Drug Administration were pre-empted under the U.S. Supreme Court’s 2008 decision in Riegel v. Medtronic Inc. and the U.S. Food, Drug and Cosmetic Act.
Los Angeles County, Calif., Superior Court Judge Michael Linfield disagreed and sided with the plaintiff, April Cabana, who argued that the federal pre-emption did not cover claims associated with “off label” uses.
“Here…plaintiff’s claim is not based on allegations that Medtronic’s device violated state tort law notwithstanding compliance with the relevant federal requirements,” Linfield wrote in a tentative order that he finalized on August 20. “In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements.”
Ilyas Akbari of Baum, Hedlund, Aristei & Goldman, who represents Cabana, said the ruling was the first at the summary judgment phase to address federal pre-emption with respect to the Infuse device, over which Medtronic faces “several dozen” lawsuits.
“The device itself is approved by the FDA for a limited purpose, a limited use,” he said. “And what Medtronic and other manufacturers are doing is saying, ‘You can also use it for this other, nonapproved use or procedure.’ And then, when they get sued because of this nonapproved use or procedure, they come back and say, ‘Well, too bad for you, it’s already been approved.’ “
He added: “Unfortunately for us, many courts have bought that argument.”
Medtronic attorney Michael Brown, a partner in the Los Angeles office of Reed Smith, referred calls to Medtronic spokeswoman Amy von Walter. “The recent court order narrowed plaintiff’s claims against Medtronic considerably and Medtronic intends to move for dismissal of the remaining claims once discovery is completed,” von Walter said via an emailed statement. She referred to Cabana’s decision to drop her strict-liability design-defect and breach-of-implied-warranty claims. Linfield’s order referred to the remaining claims of negligence, strict liability and fraud.
In 2002, the FDA approved Infuse, which stimulates bones to grow, for use during lower-back spinal surgeries.
On July 13, 2011, Cabana, then 34, sued the Medtronic defendants, plus Stryker Corp. and its subsidiary, Stryker Biotech LLC, claiming that her surgeon, in a 2008 procedure to alleviate back pain, used two Stryker products together in a way that had not been approved by the FDA. The surgery, she claimed, caused her to grow unwanted bone, which had to be removed during a second surgery in 2009. In the course of that procedure, her surgeon used Medtronic’s Infuse device in an off-label manner, she alleged. Specifically, she claimed, her surgeon implanted the device from behind, rather than through an incision in her abdomen.
As a result, Cabana claimed, her pain has gotten worse and she needed additional surgeries. She added her doctor and hospital to the complaint as defendants on October 11.
“Cabana underwent two surgeries both of which were expected to cure and remedy her lower back pain, however, neither surgery has been a success and, as a result of these surgeries and the untested, unapproved and off-label use of materials during her surgeries, her condition and pain has worsened necessitating additional curative surgeries and permanent, disabling injury,” the complaint said.
Trial in the case is scheduled for May 13.
Medtronic’s promotion of its Infuse device for off-label purposes has come under scrutiny during the past year. In her complaint, Cabana claimed that at the time of the FDA’s approval, the agency’s advisory committee raised concerns about off-label use of Infuse that risked patient safety. Despite those red flags, Medtronic publicized Infuse for use in ways the FDA hadn’t approved, the complaint said.
Cabana also cited The Spine Journal‘s July 2011 issue, which contained articles detailing the risks associated with Infuse, including increasing off-label use of the device by surgeons who were paid tens of millions of dollars by Medtronic. On June 21, 2011, Senate Finance Committee Chairman Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) asked Medtronic for documents related to Infuse as part of their own investigation into off-label marketing.
On March 30, Medtronic agreed to pay $85 million to settle a shareholder lawsuit claiming that it failed to reveal that up to 85 percent of Infuse sales came from off-label uses. Share values dropped after Medtronic revealed that federal prosecutors and the U.S. Senate had begun investigating those activities. On May 16, Medtronic announced that the Justice Department and the U.S. attorney in Massachusetts had closed their investigations.
Stryker’s actions also have come under fire. In 2009, a federal grand jury in Boston indicted Stryker Biotech and several key employees for illegally promoting the two products used in Cabana’s surgery. On January 18, Stryker Biotech pleaded guilty to misbranding a medical device and agreed to pay a $15 million fine.
Akbari said the recent ruling in the Cabana case would have implications beyond Medtronic’s devices.
“It shoots a warning arrow over the bow of manufacturers out there that says, ‘If you’re going to promote your product for use in an off-label manner, a manner not approved by the FDA, you’re not going to be able to hide behind pre-emption,’ ” he said. “ You can’t use that shield anymore. Judges are catching on, our briefings are getting a lot better, and it’s something they’ll not be able to run from anymore.”
Contact Amanda Bronstad at firstname.lastname@example.org.