A state court judge in California has ruled that a lawsuit against Medtronic can proceed, because preemption – as defined in a closely watched US Supreme Court ruling four years ago – does not apply in this instance. The lawsuit was filed over Infuse, a genetically engineered protein that has been widely used in spinal surgeries, but has also been the subject of a congressional investigation and several studies that were later repudiated (seehere and here).
In the lawsuit, April Cabana claims she suffered debilitating and permanent injuries to her spine after two different devices were implanted during surgeries. The other device was made by Stryker and Cabana claimed a surgeon used a mixture of both products in a way that was never approved by the FDA, although both device makers allegedly engaged in off-label promotion and knew harm could occur (here is the lawsuit). Her case against Stryker is proceeding and a jury trial is scheduled.
However, Medtronic argued that the lawsuit should have been summarily tossed due to preemption, which is the legal notion that FDA approval of a device supercedes state law claims challenging safety, efficacy, or labeling. But Los Angeles Superior Court Judge Michael Linfield disagreed, handing the big device maker what appears to be the first such defeat in a growing number of lawsuits over the controversial Infuse product.
Here is some background on preemption: In 2008, the US Supreme Court voted 8-to-1 that patients cannot file lawsuits against device makers when their products were approved by the FDA. At the time, Medtronic convinced the court that the Food, Drug, and Cosmetic Act expressly preempts, or supercedes, state law claims brought by patients who were hurt by devices that received premarket FDA approval (back story).
Specifically, the court decided the 1976 Medical Devices Amendment preempted the right of patients to sue for damages in state courts over devices that receive premarket FDA approval. The ruling gave device makers a welcome defense in product-liability litigation. Unlike medical devices, there is no statute providing for preemption for drugs and drugmakers lost a similar bid before the US Supreme Court in 2009 in a case over a Wyeth drug.
Cabana'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 his ruling. "In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements. Accordingly, Riegel is not authority that plaintiff’s claims against Medtronic are preempted here.” Riegel v. Medtronic was the 2008 case the device maker won.
He noted that Cabana submitted evidence supporting her allegations that, in violation of federal law and FDA regulations, Medtronic used paid consultants to train physicians, including her own physician, in using Infuse for allegedly off-label uses. Her lawsuit charged that Infuse had only been approved for a limited surgical procedure, but Medtronic illegally promoted the bone graft for various of off-label procedures.
The ruling "confirms that medical device manufacturers who violate federal law and promote their devices for non-approved surgeries should be held accountable for any injuries innocent patients suffer as a result such non-approved surgeries,” her attorney, Bijan Esfandiari of the Baum Hedland law firm, says in a statement. “Medtronic sought to create a world wherein it is permitted to violate the law and harm patients, but then be immune from all liability and responsibility.”
We have asked Medtronic for a comment and will update you accordingly. [UPDATE: On Aug. 23, a Medtronic spokeswoman sent us this: "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. Preemption remains an important defense for all products approved through the FDA's rigorous Premarket Approval (PMA) process and other courts have found claims involving Infuse barred in their entirety by federal preemption."]