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The case we discuss today, Vaughan v. Biomat USA, Inc., 2022 WL 4329094 (N.D. Ill. 2022), is neither a medical-device nor a pharmaceutical case. Nor is it a product-liability case. It is, however, a preemption case that implicates two issues relevant to our world.

The plaintiffs sold blood plasma to the defendants. When they did so, the defendants required them to scan their fingerprints for identification and tracking. Defendants required them do so to satisfy the defendants’ duty under 21 C.F.R. § 640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”

The preemption issue arises out of the arguable conflict between the federal duty to maintain such “records no less than 10 years” (21 C.F.R. § 606.160(d)) and the Illinois Biometric Information Privacy Act, which requires that an individual’s biometric data—such as fingerprints—be destroyed “within 3 years of the individual’s last interaction” with the entity that collected the data. 740 Ill. Comp. Stat. 14/15(a).

Seeking statutory damages, the plaintiffs allege that the defendants violated Illinois law when they retained the plaintiffs’ fingerprints longer than three years. Moving to dismiss, the defendants argued that federal law impliedly preempts the state-law duty both because it is impossible to simultaneously comply with the state 3-year destruction rule and the federal 10-year retention rule, and because the state rule interferes with the FDA’s goal of ensuring that prospective plasma donors are eligible to donate.

The court rejected the defendants’ argument. In the course of doing so, it made questionable statements of law and fact.

First, as a matter of procedure, the court declared that “[p]reemption … is an affirmative defense” and as such “do[es] not justify dismissal under Rule 12(b)(6).” 2022 WL 4329094, at *4 (quoting Benson v. Fannie May Confections Brands, Inc., 944 F.3d 639, 645 (7th Cir. 2019)). As the quote from the Seventh Circuit indicates, there are cases that contain this broad pronouncement. But it is misleadingly broad.

Courts, including courts within the Seventh Circuit, routinely dismiss claims under 12(b)(6) because they are preempted. See, e.g., Reddick v. Medtronic, Inc., 2022 WL 715494 (5th Cir. 2022); Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015); Otis-Wisher v. Medtronic, Inc., 616 F. App’x 433 (2d Cir. 2015); Bledsoe v. Medtronic, Inc., 2020 WL 43107 (N.D. Ind. 2020); Vincent v. Medtronic, Inc., 221 F. Supp. 3d 1005 (N.D. Ill. 2016); Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994 (S.D. Ohio 2016); Scianneaux v. St. Jude Med. S.C., Inc., 961 F. Supp. 2d 808, 812 (E.D. La. 2013); Heisner v. Genzyme Corp., 2010 WL 894054 (N.D. Ill. 2010). Heck, in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the U.S. Supreme Court affirmed the dismissal of the plaintiffs’ claims on implied preemption grounds.

Thus, as various courts have held, a “Rule 12(b)(6) motion to dismiss is a proper vehicle by which a court may consider a preemption claim.” Seagram v. David’s Towing & Recovery, Inc., 62 F. Supp. 3d 467, 477 (E.D. Va. 2014); accord, e.g., Dougherty v. Source Naturals., Inc., 148 F. Supp. 3d 831, 835 (E.D. Mo. 2015). It is, in short, “well-established that preemption may be analyzed and decided at the motion to dismiss stage.” Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644, 672 (S.D.N.Y. 2017), aff’d sub nom. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019).

Preemption is no different than any other legal basis for dismissal. Because a state-law claim preempted by federal law “fails to state a claim upon which relief can be granted,” it is subject to dismissal under Rule 12(b)(6).

It is true that when deciding motions to dismiss courts are limited to considering the complaint’s well-pleaded factual allegations, documents that are incorporated in the complaint by reference, and facts subject to judicial notice. As a result, some courts have said that a “defendant may raise the affirmative defense of federal preemption over state law claims as grounds for a motion to dismiss under Rule 12(b)(6) where the face of the complaint clearly demonstrates facts giving rise to the defense.” Brown v. Wells Fargo Bank, N.A., 869 F. Supp. 2d 51, 55 (D.D.C. 2012) (citing Smith–Haynie v. District of Columbia, 155 F.3d 575, 578 (D.C. Cir. 1998)). But—precisely because facts sufficient to establish preemption are often judicially noticeable—it is inaccurate to say that preemption may be considered on a motion to dismiss only when “the plaintiff … affirmatively plead[s] himself out of court.” Sharenow v. Drake Oak Brook Resort LLC, 2022 WL 2715854, at *4 (N.D. Ill. 2022) (quotation marks omitted).

Indeed, any rule that limited preemption-based motions to only the allegations within the four corners of the complaint would create an obvious incentive for plaintiffs to deliberately omit known facts simply to avoid dismissal on preemption grounds. Such a rule would be unfair to defendants and waste judicial resources.

In this week’s case, Vaughn, the court proceeded to consider the defendants’ preemption-based motion to dismiss notwithstanding its misguided view that such motions are improper, because the plaintiffs did not raise the purported procedural defect in their opposition to the defendants’ motion. Thus, the court’s dubious declaration regarding the propriety of raising preemption on a motion to dismiss did not affect the outcome in Vaughn.

The same cannot be said of the court’s questionable determination that the FDA “has not specifically endorsed biometric means” (2022 WL 4329094, at *5) of satisfying the data-collection requirement imposed by 21 C.F.R. § 640.65.

As noted above, the defendants argued that federal law preempts the Illinois Biometric Information Privacy Act for two reasons:  because it is impossible to simultaneously comply with the federal 10-year retention requirement and the state 3-year destruction requirement, and because requiring the destruction of biometric data collected to satisfy 21 C.F.R. §§ 630.10(g)(1) and 640.65(b)(3) would stand as an obstacle to what defendants characterized as FDA’s goal of ensuring that prospective plasma donors be eligible to donate.

The court rejected the defendants’ impossibility defense because, said the court, “[f]ederal law allows, but does not require, the use of biometric data to verify plasma donors’ identities.” 2022 WL 4329094, at *5. As the court observed, federal law requires that “blood component centers” adopt a “donor identification system” that “include[s] either a photograph of each donor which shall be used on each visit to confirm the donor’s identity, or some other method that provides equal or greater assurance of positively identifying the donor.” Id. (quoting 21 C.F.R. § 640.65). From this, the court concluded the defendants could “comply with both federal and Illinois law by obtaining proof of identity and establishing a donor identification system using photographic identification, a valid driver’s license, or any other non-biometric means.” Id.

Having rejected impossibility preemption, the court proceeded to consider obstacle preemption, which it likewise rejected.

The defendants first argued that requiring the use of photographic or other non-biometric identification was contrary to the FDA’s goal of ensuring that plasma donors are eligible to donate because “fingerprint scans best serve this purpose.” The court found that argument wanting because, according to the court, the defendants “cite[d] no authority that fingerprint scans are superior to the other forms of identification” accepted by the FDA. 2022 WL 4329094, at *5.

Citing the preamble to the final rule (Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use, 80 Fed. Reg. 29842 (May 22, 2015), the defendants further argued that, seeking to “provide flexibility to accommodate advancing technology” (id. at 29842), the FDA had “specifically endorse[d]” using “biometric means” to satisfy 21 C.F.R. § 640.65(b)(3). In support of that proposition, the defendants pointed the agency’s declaration that it “believe[d] that photographic identification, a valid driver’s license, validated biometric means, or other means can be useful in establishing the donor’s identity.” 80 Fed. Reg. at 29869.

The court read the preamble differently. Noting that “the FDA expressly refused to endorse any ‘means of establishing proof’ and stated, instead, that it ‘believe[s] that photographic identification, a valid driver’s license, valid biometric means, or other means can be useful in establishing the donor’s identity,’” the court concluded that the defendants had “not met their burden to show” that requiring use of photographic means as a matter of state law “would do major damage to clear and substantial federal interests.” 2022 WL 4329094, at *5 (quotation marks omitted).

Although the court concluded otherwise, context and Supreme Court precedent establish that the defendants ultimately have the better of the argument.

There is no question that, as the court noted, the FDA explicitly refrained from endorsing any particular method of identifying potential plasma donors. But, under Geier v. American Honda Motor Co., 529 U.S. 861 (2000), and Williamson v. Mazda Motor of Am., Inc., 562 U.S. 323 (2011), the critical question is why the agency decided to give individual entities that power to choose how they satisfy 21 C.F.R. § 640.65. If the agency allowed choice because allowing choice advanced an agency goal, then state law restricting the range of permissible choices is preempted under Geier. If, by contrast, the agency allowed choice for the convenience of regulated entities rather than to advance its own goals, then the state law escapes preemption under Williamson.

Although neither the court’s opinion nor the parties’ briefs discuss it, the preamble to the final rules leaves little doubt that the FDA sought to achieve an agency goal when it granted entities discretion when choosing how to comply with 21 C.F.R. § 640.65. The FDA’s statement that it was “not specif[ying] the means” of compliance was made in response to a public comment on the rule as proposed by the agency. The “comment stated that it is not always possible to obtain photographic identification, … that members of certain groups are reluctant to have their photographs taken,” and that the agency should therefore “allow for other means of identifying the donor.” 80 Fed. Reg. at 29869. Thus, in context, the agency’s decision to allow choice—and to allow the use of biometric information in particular—is best seen as having been made in furtherance of the agency’s goal of ensuring that all plasma donors, including those unable or unwilling to produce photographic identification, would be properly identified. Viewed in this light, a state law that effectively prohibits the use of biometric information clearly conflicts with, and thus preempted by, federal law. Flawed though it may be, Vaughn is a good reminder that our focus on medical-device and pharmaceutical cases should not blind us to decisions in other contexts that, for good or ill, speak to the issues we confront.