Since last year, a number of courts have interpreted and applied the express preemption holdings of Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008). Miller v. DePuy Spine, Inc., 07-cv-01639, 2009 US Dist LEXIS 49602 (D. Nev. May 1, 2009), is another example and, although it was decided on May 1, has just recently been picked up by LEXIS.
In Miller, the Nevada District Court granted summary judgment for the manufacturer of a PMA approved spinal implant disc called the Charite Artificial Disc. While many courts, including this one, correctly follow Riegel and hold that the state law claims challenging the design, manufacture and labeling claims are expressly preempted, this court also entered judgment for the defendant on warranty and misrepresentation claims that have a received a more mixed reception in some courts.
As to express warranty, Miller concluded that the plaintiff failed to establish the receipt of any express warranties, and that such warranty claims directly challenged the safety and effectiveness established through PMA approval of the device. The Court further held that even when couched as a warranty claim , claims are preempted when they would “impose liability for the defendant’s use of labeling approved and required by the FDA.”
The plaintiff also claimed to assert “parallel claims” contending that the implanted device was “out of conformity with the materials or manufacturing specifications approved by the FDA,” but the court dismissed these as well because plaintiff failed to meet his burden in demonstrating that there was a genuine issue of fact. As the Court succinctly noted: “Only a departure from such FDA-approved specifications could conceivably escape preemption, and absence of any evidence of such departure justifies summary judgment.”
Plaintiff’s claims that the manufacturer allegedly made misrepresentations or omissions of material information to the FDA in order to “secure or maintain the PMA” were also dismissed. Not only had the plaintiff offered only “argument about this hypothesis” rather than admissible evidence, under 21 U.S.C. Section 337(a), any attempt to enforce the FDCA and its regulations were preempted; and any contention that the manufacturer provided inaccurate or incomplete information to the FDA was impliedly preempted under Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).