Defendants love and plaintiffs hate Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), which together stand for the proposition that to state a claim and avoid dismissal a plaintiff must allege facts that plausibly suggest that the defendant is liable. Today’s case, Poozhikala v. Medtronic Inc., 2022 WL 1076173 (C.D. Cal. 2022), illustrates why defendants and plaintiffs have contrary views of Twombly and Iqbal.
Poozhikala involves a purportedly defective implantable cardiac defibrillator (ICD) whose battery was alleged to have suffered rapid battery depletion. The plaintiff asserted all the usual claims and then one: manufacturing defect; failure to warn; breach of warranty; and fraud.
Citing Twombly and Iqbal, the court made quick work of the plaintiffs’ (second amended) complaint. The court concluded that each of the plaintiff’s claims were expressly preempted by 21 U.S.C. § 360k(a) because the plaintiffs had failed to adequately allege facts plausibly suggesting that the defendant had violated any federal requirement. Sufficient allegations of a federal violation are necessary to avoid preemption under § 360k(a) because it bars any state-law requirement that is “different from, or in addition to,” the federal requirements imposed on a medical device (at least if it is a Class III device that has received premarket approval or was used under either the Investigational Device Exemption or the Humanitarian Device Exemption).
Although Poozhikala does not break new ground, is provides a nice compilation of points that bear repeating.
First and foremost, the court reiterated that for a complaint to survive a motion to dismiss, “the ‘[f]actual allegations must be enough to raise a right to relief above the speculative level.’” 2022 WL 1076173, at *2 (quoting Twombly, 550 U.S. at 555). Of course, most 12(b)(6) rulings recite this standard. All too frequently, however, courts ignore the standard when actually evaluating the sufficiency of the particular complaint before them. Not so in Poozhikala. The court did not pay mere lip service to Twombly and Iqbal; it actually applied them.
The court began with the plaintiff’s allegation that they were “informed and believe” that the defendant “violated applicable federal statutes and regulations relating to medical devices.” That did not suffice, said the court, because “Plaintiffs must allege facts plausibly showing Defendant violated federal standards” rather than make “mere conclusory assertions.” 2022 WL 1076173, at *4.
Nor was plaintiffs’ laundry “list of possible violations” sufficient because they “provide[d] no factual support” plausibly suggesting that the defendant had actually violated the listed provisions. 2022 WL 1076173, at *4.
Then the court turned to the plaintiffs’ assertion that their complaint “specified factually how the Defendant violated the federal regulations.” The court acknowledged that the complaint “does include more targeted allegations of regulatory violations,” but “closer examination,” said the court, “reveals that these too lack factual support.” 2022 WL 1076173, at *4. A closer look? How refreshing. If only every court took its obligations under Twombly and Iqbal as seriously as the Poozhikala court.
One allegation we frequently encounter, particularly in support of manufacturing-defect claims, is that the defendant violated one or more of the Current Good Manufacturing Practices (CGMPs) codified at 21 C.F.R. Part 820. As readers of this blog are aware, case law is divided over whether alleged CGMP violations can ever support a non-preempted claim (with the more persuasive cases holding that they cannot). The Poozhikala court made no grand pronouncements on the issue; indeed, it did not discuss the competing decisions. Rather, it disposed of the general claim as inadequately pleaded. Echoing other cases and quoting Weber v. Allergan, Inc., 940 F.3d 1106, 1114 (9th Cir. 2019), the court held that “[m]ere evidence suggesting that [the plaintiff’s device] was defective does not show that [the manufacturer] failed to comply with the FDA’s Current Good Manufacturing Practices,” and that “evidence that some other [devices] produced by [defendant] were defective” likewise “does not demonstrate noncompliance.” 2022 WL 1076173, at *6.
The court worked its way through a bevy of alleged violated regulations, but found each wanting. Most because the plaintiffs alleged the “violations in wholly conclusory fashion that regurgitate near verbatim the regulations themselves.” 2022 WL 1076173, at *5. “Such regurgitations, without factual support, are,” said the court, “insufficient.” Id.
Plaintiffs’ allegations weren’t entirely conclusory. They alleged some facts with respect to two purported violations. But those too were insufficient to sustain the plaintiffs’ claims.
The plaintiffs alleged that the defendant had violated 21 C.F.R. § 803.50 by failing to properly report and investigate an adverse event. In support of that allegation, plaintiffs pointed to a particular adverse event that was noted in a recall notice. Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required.
There were, the court found, two problems with the failure-to-report allegation.
To start, the plaintiffs did “not allege any relevant connection between the source of their injury … and the product recall notices, which do not discuss” the allegedly defective component at issue. 2022 WL 1076173, at *5. That is significant, because to avoid express preemption under § 360k(a), a plaintiff must plead not only a federal violation but a causal connection between that violation and the plaintiff’s alleged injury.
But, the court continued, even if the plaintiffs had sufficiently alleged a causal nexus between their alleged injury and the injury identified in the recall notice, they still hadn’t adequately pleaded a failure to report in violation of federal regulations. The court found that the plaintiffs had “fail[ed] to plausibly allege Defendant did not comply with the federal reporting and investigating requirements” because they only “speculate that Defendant did not report or meaningfully investigate” the adverse event. 2022 WL 1076173, at *5.
The court found the plaintiffs’ allegation that the defendant had violated 21 C.F.R. § 814.39(a) by failing to submit a PMA Supplement to be neither legally or factually supported. The court began with the plaintiffs assertion that the defendant “violated 21 C.F.R. § 814.39(a) after Defendant became aware of issues related to [the ICD] because Defendant was ‘required to submit a PMA supplement for review and approval … before making a change affecting the safety or effectiveness of the device.’” According to the court, “Plaintiffs are correct that a PMA supplement is required after Defendant makes a change affecting safety or effectiveness, but nowhere does the [complaint] allege Defendant made a change.” 2022 WL 1076173, at *4. The court misspoke as to the timing of PMA Supplements. Unless submitted under the changes-being-effected provision of 21 C.F.R. § 814.39(d), a PMA Supplement must be submitted before any changes are made. But the fundamental point stands: allegations of a regulatory violation cannot overcome preemption when the complaint fails to allege facts sufficient to plausibly suggest that the regulation in question was violated.
Furthermore, the court observed, “[n]othing within the regulation requires Defendant to submit a PMA supplement based on their awareness of potential issues with [the ICD] as Plaintiffs contend.” 2022 WL 1076173, at *4. At one level, this observation goes to the plaintiffs’ failure to adequately plead a regulatory violation. At another level, it points to an important point that we have noted before: § 360k(a)’s prohibition on state-law requirements different from or in addition to the federal requirements imposed on a medical device means that states cannot compel device manufacturers to do what federal law permits but does not require. As the Seventh Circuit has put it:
Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted. Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted.
McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005). Or as the Supreme Court held when interpreting the Federal Meat Inspection Act’s preemption clause, which is worded similarly to § 360k(a), a prohibition on different or additional state-law requirements means that state law cannot covert something that an entity “may” do under federal law into something that the entity “must” do under state law. National Meat Association v. Harris, 565 U.S. 452, 460 (2012).
As good as the foregoing is, the Poozhikala court delivered yet other pronouncements that do not change the law but certainly reinforce what it is in helpful ways.
For example, the court took judicial notice of an FDA recall notice. 2022 WL 1076173, at *1 & n.2. There is nothing earth-shattering about that, but it is a good reminder that motions to dismiss do not have to limit themselves to the four corners of the complaint but can instead rely on judicially noticeable materials beyond the complaint. It is often helpful to cite FDA materials, either to support certain assertion (such as the fact that a particular device has received premarket approval) or to rebut plaintiffs’ assertions (such as mischaracterizations of inspection findings in a Form 483 or of the reasons for an FDA recall notice).
The court also shot down, yet again, the now frivolous assertion that “there is a strong presumption against preemption.” The court rightly held that the “presumption does not apply here.” 2022 WL 1076173, at *4 n.3. Having already held as much in a previous ruling, the court did not spell out the reasons why that is so. But, as we have explained, the Supreme Court’s decision in Puerto Rico v. Franklin California Tax-Free Trust, 579 U.S. 115 (2016), clearly holds that when a “statute contains an express pre-emption clause, [courts] do not invoke any presumption against pre-emption.” Id. at 125 (internal quotation marks omitted).
A court that takes Twombly and Iqbal, and the Supreme Court’s other pronouncements, seriously. We can live with that. Quite happily.