The Superior Court for the County of Los Angeles ruled earlier this week in Cabana v. Stryker Biotech, LLC that a products liability action arising out of the off-label use of Medtronic’s INFUSE Bone Graft medical device could proceed by rejecting Medtronic’s summary judgment motion. Medtronic had argued that plaintiff’s claims were both expressly and impliedly preempted by the Medical Device Amendments to the Federal Food, Drug & Cosmetic Act (“FDCA”).
In the complaint, plaintiff alleged that she suffered severe pain after her doctor performed a surgical procedure using the Medtronic medical device, despite the fact that the device had not been approved by FDA for such use. Plaintiff also alleged that Medtronic had both directly and indirectly promoted the medical device for this off-label use.
Medtronic countered that it manufactured, designed and labeled the device in accordance with the FDCA and FDA implementing regulations. Section 521 of the FDA prohibits the imposition of “any requirement which is different from, or in addition to, any requirement” imposed by federal law. 21 U.S.C. § 360(k)(a)(1). Relying on that provision, and the Supreme Court’s interpretation of it in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Medtronic argued that plaintiff attempted to impose requirements both different from and in addition to requirements imposed by federal law because the device had already been approved by FDA.
The court rejected the express preemption argument on the grounds that “plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements,” therefore distinguishing this case from Riegel where allegations were premised on state tort law notwithstanding compliance with federal requirements. The court noted that Riegel expressly noted that “section 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.”
While Medtronic also argued that plaintiff’s state law claims did not amount to genuine “parallel” claims and therefore did not fall within the Riegel exception, the court found the argument unavailing because Medtronic “fails to cite to any submitted evidence in support” of the point.
The court similarly rejected Medtronic’s implied preemption argument, which was premised on Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001) and its holding that state law fraud-on-the-FDA claims were impliedly preempted because “the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration.” Because plaintiff here did not bring a claim for “fraud-on-the-FDA,” the court found Medtronic’s reliance on Buckman to be inapposite.
The case demonstrates the continued viability of state law medical device actions premised on “parallel” federal law violations, although the confines of the doctrine’s applicability still remain largely uncharted.