The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device never delivered the pain relief she had experienced during her pre-implantation pump trial, and she ultimately suffered complications. The device is a Class III medical device, requiring FDA premarket approval. Product liability litigation involving Class III devices does not get very far without bumping into federal preemption issues. Frere is no exception.
The problem with the plaintiff’s complaint was that it was either unclear or clearly preempted. The strict liability claims failed because they consisted of conclusory allegations that the purported defects or failure to warn caused her injuries. For example, in the manufacturing defect claim, the plaintiff alleged: (1) that “the catheters at issue were occluded, fractured, obstructed, and/or malfunctioning, which caused Plaintiff to suffer severe injuries and which required multiple surgeries and medical procedures to correct these defects”; and, (2) “as a direct result of the defects, Plaintiff suffered crippling injuries which left Plaintiff with permanent and significant disabilities compensable under the law.” There is no there there. Similarly, in connection with her failure to warn claim, the plaintiff alleged that “[a] foreseeable, direct and proximate result of [Defendants’] failure to warn Plaintiff, Plaintiff’s medical providers, and the FDA . . . about the defective condition of the [Device], Plaintiff suffered crippling injuries that left Plaintiff with permanent and significant disabilities.” The court refused to accept those mere “labels and conclusions.” The complaint was bereft of any facts as to how the alleged manufacturing defect and failure to warn caused her injuries. All we get is the conclusion of causation itself.
That’s before we even get to preemption. The claims run afoul of either implied, Buckman preemption by asking the court to second-guess the FDA, or run afoul of express Medical Device Amendment preemption by asking the court to impose a requirement different from or in addition to federal law. The plaintiff argued that “[t]he sum and substance of [her] claim is that the product in question was manufactured at a time when Defendants were in violation of federal regulations dealing with manufacturing processes.” That argument walks into Buckman and does not identify “specific federal requirements” that parallel California law. The plaintiff also alleged that the defendants “failed to inform or otherwise warn the FDA, medical providers, and consumers such as Plaintiff of the high failure rates” of “the catheters at issue.” But federal regulations required the defendants to report adverse events to the FDA, not to doctors, so the claim sought to impose additional requirements.
Other claims fared no better. The court was just as exacting with respect to the inevitable warranty claims as with the defect and warning claims. The plaintiff failed to plead facts that plausibly indicated that the defendants breached a warranty made beyond any statements approved by the FDA during the premarket approval process. The plaintiff alluded to “articles in medical journals, advertising and/or other documents and/or promotional materials,” but offered no reason to infer that such statements became “part of the basis of the bargain” sufficient to state a claim for breach of express warranty. Moreover, in basing an implied warranty claim solely on conduct allegedly violating the FDCA, the plaintiff once again walked off the Buckman cliff.
The fraud/misrepresentation claims walked off that same cliff, because the allegedly offending marketing materials had all been reviewed by the FDA as part of the PMA process. The plaintiff never suggested that the statements exceeded the scope of any statements approved by the FDA. Moreover, and predictably, the fraud claims flunked the Rule 9 particularity requirement. The complaint did not allege the when and where of the misrepresentations, to whom they were made, and how they were false.
The complaint also included an allegation that the defendants had failed to train the plaintiff’s medical providers regarding how to install the device. The court held that such a claim can survive “only to the extent the manufacturer failed to provide the training required by the premarket approval process.” Here, the plaintiff did not allege any facts regarding how the defendants’ training procedure deviated from the training procedure approved by the FDA in the premarket approval process. Nor did the plaintiff assert any causal connection between the potential training deviations and her injuries. Those failures derailed the training claim.
Finally, the court dismissed the plaintiff’s claim under California’s Unfair Competition Law. That claim sounded in fraud and was therefore subject to the same particularity pleading requirement that knocked out the fraud claims. Again, the complaint failed to state how the alleged misrepresentations “immediatel[ly]” caused the plaintiff’s injuries.
These rulings resulted in a dismissal of the entire Frere complaint. But the court saw a possibility that the plaintiff could reallege her claims “to evade preemption,” so dismissal was with leave to amend. In all likelihood, we will report again on this case in the not-too-distant future.