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We had occasion recently to reread Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims:

[The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.  It approved, for example, under its Humanitarian Device Exemption procedures, a ventricular assist device for children with failing hearts, even though the survival rate of children using the device was less than 50 percent.

Id. at *318 (citation omitted).

Given the example Riegel used, that discussion would seem to mean that devices categorized as “humanitarian” (also “HDE”) under FDA’s regulations should be subject to extensive “premarket” device preemption.  The FDA defines a “humanitarian device” as:

a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.

FDA, “Humanitarian Device Exemption,” available online hereSee generally R. Rabin & A. Picard, “Reassessing The Regulation Of High-Risk Medical Device Cases,” 68 DePaul L. Rev. 309, 317 (2019) (discussing humanitarian device approval).

We decided to see if that was true.

It turns out we were right, although there are not many cases.  In Brandt v. Medtronic, Inc., 179 F. Supp.3d 963 (D. Nev. 2016), which we mentioned here, plaintiff brought a number of claims against the manufacturer of a Riegel-style humanitarian device.  Id. at 966 (“FDA’s PMA review of the . . . Device proceeded through a humanitarian device exemption”).  Brandt pointed out that an FDA humanitarian device review “is similar to the PMA process, but . . . alleviates the need to demonstrate scientifically that the device is effective.”  Id.  As far as safety is concerned, however:

[T]he FDA must find that “the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use.”

Id. (quoting 21 U.S.C. §360j(m)(2)(C)).  Thus, the safety aspects of humanitarian device review are no different than other forms of PMA, and that’s what counts from a product liability perspective.  Id. at 967 (“there is no dispute that the . . . Device was subjected to a PMA process, albeit through an HDE”).  Thus, all of the plaintiffs’ claims in Brandt “fit within the broad preemptive reach of §360k(a)” and were dismissed.  Id.  Nor did plaintiff plead any unpreempted parallel violation claims  Id. at 967-68.

More recently, a similar result ensued in Sundaramurthy v. Abbott Vascular, Inc., ___ F. Supp.3d ___, 2022 WL 827235 (D. Mass. March 18, 2022), involving another device that “received premarket approval from the FDA . . . under a Humanitarian Device Exemption.”  Id. at *2.  Once again, “general allegations” involving tort claims were preempted.  Id.; accord Sundaramurthy v. Abbott Vascular, Inc., 2021 WL 7542704, at *3 (D. Mass. Dec. 6, 2021) (previously preempting same claims).  Unlike Brandt, however, Sundaramurthy attempted to plead parallel claims, with enough success to avoid complete dismissal.  “In sum, the plaintiff may proceed on a manufacturing defect theory, but not on failure to warn or design defect theories.”  Id. at *3.

In case our readers forget, we also include humanitarian device cases in our PMA preemption scorecard.

Finally, although not actually involving humanitarian devices, the following cases mention them as preempted in the context of discussing RiegelIn re Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306, 1353 n.48 (N.D. Ga. 2015); Wilhite v. Howmedica Osteonics Corp., 833 F. Supp.2d 753, 756 (N.D. Ohio 2011); Gelber v. Stryker Corp., 788 F. Supp.2d 145, 151 (S.D.N.Y. 2011).