A Los Angeles Superior Court judge rejected attempts by Stryker and Medtronic to dismiss Plaintiff April C. Cabana’s claims that the devices used during two back surgeries caused her to suffer permanent disabling injuries. Cabana alleges the devices used during her surgeries were fraudulently promoted by the medical device companies for off-label use and that the companies failed to disclose that the products could cause serious complications and lacked effectiveness.
Cabana, whose spine surgery was conducted to repair a herniated disc, claims the off-label use of two Stryker products (OP-1 Putty and Calstrux) resulted in excessive bone growth migration in her lower back, causing permanent nerve damage and severe pain. In her second surgery, “bone of unknown origin” was removed from her lower back, and fusion was attempted with a Medtronic product (Infuse Bone Graft), which was also used in an off-label manner. This second surgery failed and caused further spine destabilization. Cabana is now permanently disabled.
This was Stryker’s first attempt and Medtronic’s second attempt to dismiss Cabana’s case based on the preemption (immunity) defense. The Honorable Michael P. Linfield rejected Medtronic’s prior attempt to dismiss Ms. Cabana’s case. Following Judge Linfield’s ruling, the case was transferred to the Honorable Terry A. Green of Los Angeles Superior Court because of major shifts in California’s court system due to budget cuts.
On September 9, 2013, Judge Green heard oral argument on motions for summary judgment filed by Stryker and Medtronic in a medical device personal injury case, Cabana v. Stryker et al. After hearing oral argument, Judge Green denied the defendants’ motions.
Stryker, which pled guilty in 2012 to illegally promoting the off-label use of OP-1 and Calstrux (the same two devices used during Cabana’s lumbar back surgery), argued that federal law preempted Ms. Cabana’s claims, and thus the company was entitled to full immunity. In rejecting Stryker’s preemption/immunity defense, the Court stated it would be a “draconian result” if Stryker were entitled to immunity given Ms. Cabana had presented evidence that Stryker had promoted OP-1 and Calstrux for unapproved combination uses.
The Court also rejected Stryker’s argument that it had provided adequate warnings, stating, “[t]he fact that the company [Stryker] was sending reps out to do exactly what the …label said not to do tends to diminish the effect of the label.” The Court went on to conclude that, “[a]s a matter of law … under these facts, I can’t say that the label was sufficient in light of everything else. Under the facts of this case, I can’t say that a company … knowing there’s a problem and sitting on the information while their people are going out there and engaging in conduct that is prohibited under their label, and telling everybody that this is a great product, better than the competition, and it’s safe when there is knowledge to the contrary, it does sort of carrying through all the causes of action.”
In sum, the Court held that Ms. Cabana presented sufficient evidence to create triable issues of fact on her strict liability failure to warn, negligence, negligence per se, breach of warranty and fraud causes of action as well as her claim for punitive damages against Stryker.
Medtronic likewise argued that it was entitled to full immunity because federal law preempted Ms. Cabana’s claims, according to Medtronic. Judge Green, relying in part upon an earlier decision issued by the Honorable Michael P. Linfield in this same case, held that federal law did not preempt Ms. Cabana’s claims against Medtronic. Specifically, Judge Green stated: “I think [Judge] Linfield’s analysis was excellent, well-reasoned, well presented, and I agree with it.”
Judge Green also rejected all of Medtronic’s other arguments and held that there was evidence that Medtronic knew its device, Infuse, “had problems when used in a certain manner, and yet not disclosing that. Indeed advertising it in the contrary.” Judge Green went on to note that “…there was a lot of misleading information being disseminated, and there’s some evidence of Medtronic’s fingerprints on those.” Accordingly, Judge Green denied Medtronic’s motion in its entirety, permitting Ms. Cabana to proceed to a jury trial on all of her causes of action, including negligence, negligence per se, breach of warranty, and fraud as well as her claims for punitive damages against Medtronic.
In rejecting Medtronic’s preemption arguments, Judge Green has lent his voice to a chorus of other federal and state judges across the country that have likewise rejected Medtronic’s claims of immunity. Judge Green’s ruling should keep the doors of justice open to other injured Infuse patients who have been harmed as a result of Medtronic’s wrongful conduct.
In reacting to the Court’s ruling, Ms. Cabana’s counsel, Bijan Esfandiari, stated, “we and our client are pleased with the Court’s ruling rejecting Stryker and Medtronic’s baseless immunity arguments. The Court’s 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 of such non-approved surgeries.” Mr. Esfandiari further added, “Through their arguments, Medtronic and Stryker sought to create a world wherein they are permitted to violate the law and harm patients, but then be immune from all liability and responsibility. The Court correctly rejected such ‘draconian’ arguments.’”
The case is scheduled for a February 10, 2014 jury trial.