Not too long ago we saw a story in the legal press about a newly filed case in Minnesota where the plaintiff claimed that the FDA was going easy on the defendant because it approved “hundreds of premarket supplements” rather than requiring “a new PMA application.” Supposedly “[b]y utilizing the [premarket approval] supplement process instead of filing a new PMA application, [the defendant] avoided the rigorous scientific review, public comment and clinical trial requirements.”
That’s barnyard excrement. This plaintiff isn’t just wrong s/he is loud wrong – which, for plaintiffs, is unfortunately rather common.
The standards for FDA approval of a PMA supplement are “largely the same criteria as an initial application.” Riegel v. Medtronic, Inc., 552 U.S. 312, 319 (2008). The Riegel court knew what it was talking about. The device in Riegel was itself approved through a PMA supplement. See Riegel v. Medtronic, Inc., 451 F.3d 104, 120 (2d Cir. 2006) (“when [defendant] wanted to revise the [device’s] label, it submitted PMA supplements that requested approval for those revisions”), aff’d, 552 U.S. 312 (2008). The Supreme Court in Riegel cited an FDA regulation:
All procedures and actions that apply to an application under §814.20 also apply to PMA supplements except that the information required in a supplement is limited to that needed to support the change.
Just as the Supreme Court in Riegel did not distinguish between the original PMA and subsequent PMA supplements in its preemption analysis, neither have other courts. They hold that, because PMA supplements must meet the same safety and effectiveness standards applicable to their original PMAs, devices approved by PMA supplement enjoy the same degree of preemption that arises from initial PMAs. This has been settled law for over a decade. The Sixth Circuit evaluated and resoundingly rejected similar arguments in Kemp v. Medtronic, 231 F.3d 216, 227 (6th Cir. 2000) (another case that pre-Blog Bexis helped brief):
[T]he PMA Supplement . . . is composed of more than a hundred-page submission, and like the PMA, if the FDA ultimately grants approval to the modification in question, it means that the FDA has received reasonable assurances of the device’s safety and effectiveness. . . . Hence, we agree with the district court’s analysis that “preemption analysis regarding products approved through the PMA process is fully applicable to products approved through the PMA Supplement process.”
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[P]laintiffs’ expert merely avers that a PMA Supplement is not reviewed with the same rigor as a PMA. This distinction is readily understandable because a PMA requires review of a previously unapproved device that does not qualify for exemption. . . . By contrast, a PMA Supplement proposes changes to a device that has already received rigorous review and approval during the original PMA process. Hence, because the FDA has already made a determination as to the safety and effectiveness of the underlying device in the original PMA, it can evaluate only the proposed modifications presented in the PMA Supplement while relying on its earlier approval of the original device.
Id. at 227 (citations and quotation marks omitted). Accord Walker v. Medtronic, Inc., 670 F.3d 569, 573-74 (4th Cir. 2012) (“A premarket approval application supplement is ‘evaluated under largely the same criteria as an initial application.’”) (quoting Riegel); Bass v. Stryker Corp., 669 F.3d 501, 508 (5th Cir. 2012) (“Supplemental premarket approval is evaluated largely by the same procedures, criteria, and extensive scrutiny as the original PMA process.”) (quoting Purcel v. Advanced Bionics Corp., 2010 U.S. Dist. Lexis 67109, at *8-9 (N.D. Tex. June 30, 2010)); Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005) (“Any claim, under state law, . . . that Defendant failed to warn patients beyond warnings required by the FDA, or that Defendant failed to recall a product without first going through the PMA supplement process would constitute state requirements ‘different from’ or ‘in addition to’ the requirements of the federal PMA application and supplement process”) (citations omitted); Smith v. Depuy Orthopaedics, Inc., 552 F. Appx. 192, 193 n.2 (3d Cir. 2014) (“Any change to a PMA-approved device requires supplemental approval, which ‘is evaluated largely by the same procedures, criteria, and extensive scrutiny as the original PMA process’”) (quoting Bass).
State court decisions, while not as numerous, are in accord. Blunt v. Medtronic, Inc., 760 N.W.2d 396 (Wis. 2009), likewise recognized that, under FDA regulations, “In order to obtain ‘supplemental approval’” the defendant “must submit, and the FDA must approve, an application . . . to be evaluated under largely the same criteria as an initial application’ for premarket approval.” 760 N.W.2d at 400 (quoting Riegel). Equal regulatory rigor meant equal preemption. Blunt strongly rejected the plaintiffs’ argument that supplemental FDA approval somehow “superseded” the agency’s original approval:
We have found nothing in the comprehensive federal regulatory scheme that suggests a change in device-specific premarket approval of a Class III medical device occurs simply because a subsequent device has received supplemental premarket approval. . . . Accordingly, we conclude that the supplemental premarket approval that [defendant] received did not affect the federal requirement of premarket approval granted to the original [device].
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[T]he federal government’s approval of the supplemental device did not affect the approval of the original device. Accordingly, a state tort claim will be preempted by the original federal approval. . . . Therefore, we conclude that when a manufacturer obtains supplemental approval for a medical device . . ., prior approvals of the device remain valid and accordingly the federal requirement established by premarket approval of the original [device] is ongoing.”
760 N.W.2d at 407-08 (footnote omitted). The device at issue in Blunt had received “either 23 or 29” PMA supplements. Id. at 400 n.9.
Similarly, Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127 (Tex. App. 2005), rejected the plaintiffs’ argument that PMA supplements were entitled to less preemptive weight than initial PMAs. Baker first recognized that “[t]he procedures for a PMA supplement are the same as those for an original PMA, although the FDA requires only that the manufacturer provide materials supporting the proposed modification.”) (citations omitted). Id. at 131. It then held:
There is no categorical distinction between a device approved solely on a PMA application and a device that has been approved through a PMA application coupled with a subsequent PMA supplement. If we were to accept [plaintiffs’] argument that the PMA supplement must itself be as exhaustive as the initial PMA, there would be no need for PMA supplements. Rather, an entire new PMA application would be required for each product innovation. Therefore, in analyzing whether the PMA approval process is sufficient to support a finding that federal regulations were imposed, we believe that we must look at the initial PMA and the PMA Supplement together. Thus, the proper inquiry is to consider the initial PMA application and the PMA supplement, as a whole, in determining whether federal requirements have been imposed.
Likewise, Jessen v. Mentor Corp.,...
