We’ve just been informed of Phillips v. Medtronic, Inc., SUCV2009-05286-A, slip op. (Mass. Super. July 10, 2012), granting a preemption motion under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in a case involving a pain pump (it’s over a week old, so it’s only “new” by non-blogging standards). Unlike many pain pump cases, the device in Phillips was a Class III FDA pre-market approved (PMA) device.
The device in Phillips was labeled for intrathecal (spinal) use (also unlike most pain pump cases, which involve the shoulder joint). It was the subject of a recall in 2008, four years after the plaintiff’s surgery. Slip op. at 2.
The plaintiff in Phillips alleged “parallel” violation claims that parroted statements in two FDA warning letters. Slip op. at 3-6 (quoting large chunks of the letters − this is one thorough judge). The amended complaint, filed after the court warned plaintiff about preemption, alleged violations of no fewer than fourteen provisions of the FDCA or FDA regulations. Id. at 6-7.
None of regulatory mud that plaintiff threw against the wall stuck. The amended Phillips complaint was dismissed under the Massachusetts equivalent of Rule 12 and the Massachusetts equivalent of TwIqbal.
The claimed regulatory violations were simply not causal. Although the court let the plaintiffs slide on both the vagueness of the GMPs and the vagueness of her pleadings (slip op. at 11-16), she could not escape the FDA’s warning letters. They did not involve what plaintiff claimed had happened.
It is clear from the [warning letters] that all of these [GMP] violations relate to tip bonding manufacturing procedures. . . . Insofar as catheter tip detachment is not the manufacturing defect alleged to have caused [plaintiff’s] injuries, the plaintiffs fail to state a plausible claim on the cited [GMP] violations, even under an indulgent reading of the complaint.
Slip op. at 17.
Plaintiff also alleged violations of medical device reporting obligations owed to the FDA. Slip op. at 17-18. Forget express preemption; claims based on failure to provide information to the FDA are barred under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), since the Supreme Court there held that only the FDA can enforce reporting obligations owed to it:
[A] parallel claim based on failure to report adverse events, corrections, removals, and failure to submit supplemental reports to the FDA is impliedly preempted because it is premised solely on a duty created by the MDA [Medical Device Amendments] which did not exist in the common law: the duty to provide information to a regulatory agency to enable it to determine whether to take enforcement action.
Slip op. at 21. The judge was admittedly “reluctant” to reach this result, but the plaintiff’s allegations left no doubt that these were Buckman-preempted claims. Id.
Thus we add another favorable outcome to our medical device preemption scorecard.