Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. After all, PMA “is in no sense an exemption from federal safety review − it is federal safety review.” Id. at 323. Thus, by a 7-2 margin the Court held, per Justice Scalia, that all state-law liability claims before it – “strict liability; breach of implied warranty; and negligence in the [product’s] design, testing, inspection, distribution, labeling, marketing, and sale,” id. at 320 – were expressly preempted:
The language of the statute does not bear the [plaintiffs’] reading. The [Medical Device Amendment] provides that no State “may establish or continue in effect with respect to a device … any requirement” relating to safety or effectiveness that is different from, or in addition to, federal requirements. § 360k(a) (emphasis added). [Plaintiffs’] suit depends upon [the state’s] “continu[ing] in effect” general tort duties “with respect to” [defendant’s] catheter.
Id. at 328 (citation omitted). Thus, “the MDA sets forth a general rule pre-empting state duties having the force and effect of law (whether established by statute, ordinance, regulation, or court decision). Id. at 329 (citation and quotation marks omitted) (emphasis original). “Safety and effectiveness are the very subjects of the [plaintiffs’] common-law claims,” so they were all preempted as conflicting state requirements. Id. at 323. The lower court’s dismissal of all of the plaintiffs’ claims was therefore affirmed. Id. at 330.
As for “parallel claims” Riegel stated that, “[a]lthough [plaintiffs] now argue that their lawsuit raises parallel claims, they made no such contention . . . before the Second Circuit, nor did they raise this argument in their petition for certiorari,” so the Court “decline[d] to address that argument in the first instance here.” Id. at 330.
Despite that waiver, subsequent plaintiffs have successfully converted Riegel‘s dictum about parallel claims – that “a damages remedy for claims premised on a violation of FDA regulations” would be “‘parallel,’ rather than add to, federal requirements” – into a widely recognized exception to the broad express preemption recognized in Riegel. As our post-Riegel medical device preemption scorecard details (currently describing all 664 PMA preemption decisions that we believe exist), over the ensuing 15 years courts have varied in how widely they construe this questionable exception. But until Wilson v. CooperSurgical, Inc., 2023 WL 6216933 (S.D. Ill. Sept. 25, 2023), no court had slid all the way to the bottom of the “parallel claim” slippery slope. Wilson went there, however, denying the defendant’s motion to dismiss entirely and holding that, at least for purposes of Rule 12, none of Riegel’s actual rulings mattered and everything could be considered a ”parallel” claim. Thus, in Wilson, for the first time a court held, in effect, that Riegel’s parallel claim dictum completely swallowed Riegel’s actual holdings.
Nor was Wilson a peculiar situation where the plaintiff, fearing preemption, brought a couple of limited claims that had the best chance of avoiding express PMA preemption. Quite the opposite. Wilson considered a blunderbuss “10-count, 93-page Complaint,” id. at *1, that included strict liability, negligence and “gross negligence” claims attacking how the device – contraceptive clips – was designed and also alleging failure to warn.
That the device in Wilson was a contraceptive probably mattered. According Wikipedia, Wilson was decided by a Trump-appointed judge from St. Clair County (an Illinois judicial hellhole) who was “a member of the Alliance Defending Freedom,” a group that “works to . . . outlaw abortion,” among other things. That’s a toxic mix, indeed, when combined with the plaintiffs’ bar’s latest concerted attempt to drive a form of birth control off the market through product liability litigation.
So how did every claim in Wilson end up evading PMA preemption, notwithstanding Riegel? It didn’t help that Illinois is in the Seventh Circuit, and thus Wilson was controlled by the infamous decision in Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010), which is undoubtedly the worst post-Riegel appellate PMA preemption decision of all. Wilson interpreted Bausch broadly, finding it to be a “procedural tripwire.” 2023 WL 6216933, at *5. Even though neither party argued it, id. (“the parties without discussion”), Wilson held that Bausch forbade altogether the adjudication of preemption motions on motions to dismiss because preemption is an “affirmative defense.”
[A]n affirmative defense must be raised in the answer, not by motion . . ., because a plaintiff, when drafting a complaint, is not required to anticipate or refute affirmative defenses. Also, motions under Rule 12(b)(6) are limited to instances where the law does not confer a right to relief, and it is rare that “the face of the complaint [will] so clearly prove the opponent’s affirmative defense that immediate dismissal, prior to the filing of an answer, will be proper.
Id. at *5 (citing, inter alia, Bausch; other citations and quotation marks omitted).
This “tripwire” is at a minimum way overstated. Indeed, the United States Supreme Court itself has frequently affirmed preemption in cases that, procedurally, involved Rule 12 motions. Here are a few such Supreme Court preemption decisions rendered just since Bausch. E.g., Kindred Nursing Centers Ltd. Partnership v. Clark, 581 U.S. 246, 253-54 (2017); Northwest, Inc. v. Ginsberg, 572 U.S. 273, 288 (2014); PLIVA, Inc. v. Mensing, 564 U.S. 604, 624-25 (2011) (FDCA preemption case).
Wilson, however, poo-pooed precedent that found preemption on motions to dismiss as employing procedural “shortcuts.” 2023 WL 6216933, at *6. Rather, Wilson “articulated” a “stringent standard.” Id. A plaintiff would have to “plead” himself “out of court” to lose a preemption motion in this courtroom. Id.
[T]he Court declines to dismiss Plaintiff’s Complaint based on Defendants’ affirmative defense of preemption. While Plaintiff positively addressed preemption in the Complaint and did not object to the Court’s consideration of that affirmative defense under Rule 12(b)(6), the Court finds Plaintiff did not plead out of court.
Id. Exactly how much contrary precedent did Wilson have to ignore to reach this result? That’s hard to say, but it is undoubtedly quite a lot. We keep track of the procedural posture of preemption cases in our PMA preemption scorecard, and the phrase “dismiss granted” (indicating the grant of a Rule 12 motion to dismiss) occurs 397 times. And our scorecard doesn’t purport to count all of the other federal preemption contexts – such as the three post-Bausch Supreme Court cases cited above – in which courts have enforced the Supremacy Clause of the Constitution on motions to dismiss.
There’s also TwIqbal, where the Supreme Court enforced Rules 8 and 12, while expressly holding, twice, that a plaintiff had to state a claim before subjecting the defendant to discovery:
It is no answer to say that a claim just shy of a plausible entitlement to relief can, if groundless, be weeded out early in the discovery process through careful case management. . . . And it is self-evident that the problem of discovery abuse cannot be solved by careful scrutiny of evidence at the summary judgment stage. . . . [T]he threat of discovery expense will push cost-conscious defendants to settle even anemic cases before reaching those proceedings. Probably, then, it is only by taking care to require allegations that reach the level suggesting [liability] that we can hope to avoid the potentially enormous expense of discovery
Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 559 (2007).
[T]he question presented by a motion to dismiss a complaint for insufficient pleadings does not turn on the controls placed upon the discovery process.
* * * *
We decline [plaintiff’s] invitation to relax the pleading requirements on the ground that the Court of Appeals promises petitioners minimally intrusive discovery. . . . Because [plaintiff’s] complaint is deficient under Rule 8, he is not entitled to discovery, cabined or otherwise.
Ashcroft v. Iqbal, 556 U.S. 662, 684-85, 686 (2009) (citations, including to Twombly, omitted).
But once again Wilson gave short shrift to Supreme Court precedent, holding instead that a perceived need for discovery excused any failure by the plaintiff to plead a plausible parallel claim. Plaintiffs should be given the opportunity to “flesh out” their complaint after “participation in discovery.” 2023 WL 6216933, at *7.
Plaintiff indicated, once she obtained the PMA approval order and related documents through discovery, Plaintiff would amend the Complaint based on the specific requirements set forth therein as necessary. As noted above, in cases alleging the defective manufacture of a medical device, courts must keep in mind that much of the product-specific information about manufacturing needed to investigate such a claim fully is kept confidential by federal law, such that formal discovery is necessary before a plaintiff can fairly be expected to make detailed statements on the specific bases of her claims.
Id. (citing Bausch, other citations and quotation marks omitted). That rationale is about as far from the Supreme Court’s holdings in TwIqbal, quoted above, as it is possible to be.
Having disposed of preemption by completely negating Riegel through procedural gymnastics, Wilson proceeded to make a hash of Illinois tort law as well. Again citing Bausch, the decision indicates that “a violation of a statute, designed to protect human life, is prima facie evidence of negligence in Illinois.” 2023 WL 6216933, at *7. That single-sentence discussion overlooked Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352 (Ill. 1996), which directly addressed the “the doctrine that the violation of a statute, ordinance, or regulation designed for the protection of life or property is prima facie evidence of negligence,” in the context of the FDCA. Id. at 355. This doctrine could not apply to the FDCA because.
[T]he instant plaintiffs seek to premise a private cause of action in State court upon defendant’s alleged violation of Federal legislation. Therefore, to determine whether a cause of action for a violation of [an FDA regulation] exists, we examine whether such a cause of action has been recognized by the Federal courts or whether recognizing such a cause of action comports with Federal legislative intent. This inquiry forecloses plaintiff’s cause of action. Federal courts have uniformly refused to imply a private cause of action under the Food, Drug and Cosmetic Act (FDCA).
Id. at 356 (emphasis added). Moreover, Martin was decided before Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), which put an end to any doubt about this proposition. Id. at 349 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance”). So, in less than a paragraph, Wilson managed to reach a result contrary to both the United States and Illinois supreme court precedent.
In that same muddled paragraph, Wilson also appears to hold that a failure to report claim, although not described in any detail, can state a cause of action of action under Illinois law so as to overcome a motion to dismiss. 2023 WL 6216933, at *7. Wilson stated that some “associated duty,” presumably associated with the purported FDCA violation claim, “is not limited to issuing warnings directly to end users” and cited Laverty v. Smith & Nephew, Inc., 197 F. Supp.3d 1026, 1032 (N.D. Ill. 2016), an early case that improperly predicted that Illinois would allow a failure to report claim in the absence of any supportive Illinois precedent. 2023 WL 6216933, at *7.
Since Laverty, however, an Illinois appellate court has flatly rejected this theory of liability. Norabuena v. Medtronic, Inc., 86 N.E.3d 1198 (Ill. App. 2017), held that a state-law duty to warn a physician “is not synonymous with an affirmative duty to warn a federal regulatory body.” Id. at 1207. Illinois law does not recognize a duty to report adverse events to the FDA. “[A]lthough plaintiffs have identified a federal requirement that their complaint alleges [defendant] violated, there is no [state] requirement that parallels it.” Id. at 1206.
The learned intermediary doctrine states that a manufacturer has a duty to warn prescribing physicians of a drug’s known dangerous propensities under the understanding that those physicians will use their expert knowledge in adequately warning the patient. We cannot find that this duty is parallel to the federal requirement.
Id. at 1207 (citation omitted).
Norabuena is fully supported by general Illinois law, which consistently rejects warning-based tort claims based on claimed failure to make reports to any government agency. In a child abuse case, the Illinois Supreme Court held:
[W]ith regard to the appellate court’s holding that defendants had a duty to report [the] conduct to authorities, the common law does not recognize an affirmative duty to act for the protection of another in the absence of a special relationship between the parties.
Jane Doe-3 v. McLean County Unit Dist. No. 5 Board of Directors, 973 N.E.2d 880, 889 (Ill. 2012).
Numerous state and federal appellate courts applying Illinois law have likewise rejected purported common-law claims based on failure to make mandatory reports to various government agencies. Anticipating the Illinois Supreme Court, Doe-2 v. McLean County Unit Dist. No. 5 Board of Directors, 593 F.3d 507, 514 (7th Cir. 2010), also rejected any common-law duty to report child abuse to government agencies under Illinois law:
But [defendant’s] mandate to report child abuse does not create any duty to the abused child enforceable under Illinois tort law. . . . [Failure to report] does not give rise to a private tort action unless the violation also breaches a common law duty of care owed to the plaintiff. . . . [Plaintiff] cannot rely on [the defendant’s] alleged violation of [statutory] reporting requirements to support her private tort claims; she must identify a common law duty owed to her by the defendants.
Id. at 514 (citations omitted). See also Varela v. St. Elizabeth’s Hospital of Chicago, Inc., 867 N.E.2d 1, 11 (Ill. App. 2006); Doe 1 v. North Central Behavioral Health System, Inc., 816 N.E.2d 4, 7-8 (Ill. App. 2004); Sheetz v. Norwood, 608 F. Appx. 401, 406 (7th Cir. 2015); E.L.T., Inc. v. Wachovia Corp., 403 F.3d 474, 476 (7th Cir. 2005); Cuyler v. United States, 362 F.3d 949, 952-53 (7th Cir. 2004) (Posner, J.); Necheles v. Board of Education of Dwight Twp. High School Dist. #230, 2020 WL 1905967, at *4 (C.D. Ill. April 17, 2020); Doe v. White, 627 F. Supp.2d 905, 920 (C.D. Ill. 2009).
For all of these reasons, we’re pretty sure that Wilson will claim a bottom-ten spot on our annual “worst decisions” list. As should already be clear from our posts concerning the Alliance for Hippocratic Medicine litigation, we’re sick and tired of ideological judges misapplying the law concerning reproductive health in order to suit their political preferences.