North Carolina Lawyers Weekly
Walker v. Medtronic Inc. (Lawyers Weekly No. 12-01-0117, 28 pp.) (Duncan, J.) No. 10-2219, Jan. 25, 2012; USDC at Charleston, W.Va. (Faber, J.) 4th Cir. Click here for full-text opinion.
Holding: The 4th Circuit upholds the district court decision that plaintiff has no common law tort claim against defendant Medtronic, maker of the allegedly defective SynchroMed pump for delivery of medication through a catheter, as her claim is preempted by the Medical Device Amendments of 1976 and regulations which provided for premarket approval by the federal Food and Drug Administration.
Plaintiff Sherry Walker appeals the district court decision for Medtronic that her claim is preempted by the MDA, as interpreted by Riegel v. Medtronic Inc., 552 U.S. 312 (2008). Walker argues that because the device in question – Model 8627-18 SynchroMed EL Programmable Pump implanted in Walker’s s husband to treat chronic back pain – allegedly failed to operate in accordance with the terms of its premarket approval, her claims parallel federal requirements and therefore should avoid preemption. Walker alleges the pump malfunctioned and overinfused an unaccounted for amount of hydromorphone into her husband’s body, causing his death.
In light of Walker’s concession that the device was designed, manufactured and distributed in compliance with the terms of its premarket approval, given by the FDA as required under the MDA, however, we are compelled to affirm.
The exclusive provisions of the FDA regulatory process recognize only one mechanism for the creation of an enforceable requirement governing the ongoing performance of a medical device, and that is through the establishment of a formal performance standard. Walker concedes that no such performance standard was created here. This concession makes clear that her common law claims seek to impose requirements above and beyond those of the FDA, thus bringing them within the category expressly preempted by the MDA. To hold otherwise would be to undermine the balance Congress struck when it enacted the MDA, in which it determined that the benefit to the many of bringing potentially lifesaving, but risky, medical devices to the public following the rigorous process of FDA approval outweighed the cost to the few of preempting common law claims based on different standards.
Because the SynchroMed pump was undisputedly designed, manufactured and distributed in compliance with its FDA premarket approval, and plaintiff’s common law claims exceed or differ from, rather than parallel, federal requirements, we hold that each of her specific claims for negligence, strict liability and breach of warranty is preempted.
Judgment for manufacturer affirmed.
Dissent
Wynn, J.: This case boils down to a choice of whether the FDA specification that a deadly medical device, an internally implanted pump, “maintain [ ] the delivery accuracy of a ± 15%” is a requirement, or whether it is a mere aspirational figure. Because I believe the accuracy rate specification is indeed a requirement, and because the medical device’s failure to meet that requirement underlies plaintiff’s state law claims, I would hold that her claims are not preempted under Riegel v. Medtronic Inc., 552 U.S. 312 (2008). I therefore respectfully dissent.
