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.

21 C.F.R. §814.39(c)(1).

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.”

*          *          *          *

[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].

*          *          *          *

[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.

Id. at 135-36.

Likewise, Jessen v. Mentor Corp., 71 Cal. Rptr.3d 714 (Cal. App. 2008), rejected a claim that a PMA supplement did not qualify for the broad preemption recognized in Riegel, holding just the opposite – that “[u]se of the supplement process, in fact, confirms the [device] is a class III medical device” because the manufacturer “would not have needed a PMA supplement unless it had previously received FDA authorization through the PMA process.”  Id. at 723.

Numerous – literally dozens – of federal district court decisions also confirm that FDA approval of PMA supplements applies the same safety standards, is subject to the same rigorous regulatory review, and thus has the same preemptive effect, as initial FDA PMA approval.  See Ferguson v. Bayer Essure, Inc., 2023 U.S. Dist. Lexis 177501, at *4 n.1 (D.N.M. Sept. 29, 2023) (“The PMA supplement is “evaluated under largely the same criteria as an initial application.”) (quoting Riegel); Armstrong v. ABC Corp., 2023 U.S. Dist. Lexis 168568, at *17 (Mag. W.D. La. Aug. 21, 2023) (“accept[ing]” that PMA supplements establish that the device “underwent the PMA process”), adopted, 2023 U.S. Dist. Lexis 169676 (W.D. La. Sept. 22, 2023); McNeil-Williams v. Depuy Orthopaedics, Inc., 384 F. Supp.3d 570, 574 (E.D.N.C. 2019) (“supplemental premarket approval[ is] evaluated under largely the same criteria as an initial application”) (quoting Riegel); Calloway v. Coloplast Corp., 2019 U.S. Dist. Lexis 83870, at *9 (Mag. W.D. La. Feb. 5, 2019) (multiple PMA supplements establish that the device “is a Class III medical device that went through the FDA’s premarket approval process”), adopted, 2019 U.S. Dist. Lexis 83798 (W.D. La. May 17, 2019); Vincent v. Medtronic, Inc., 221 F. Supp.3d 1005, 1010 (N.D. Ill. 2016) (“The original premarket approval process, along with any supplemental premarket approvals obtained prior to the surgery, established federal requirements in the form of FDA-approved specifications and procedures”) (citation omitted); Gates v. Medtronic, Inc., 192 F. Supp.3d 704, 710 (W.D. Tex. 2016) (“to the extent that the PMA process constitutes the imposition of federal requirements under the first prong of Riegel, so too does the process for obtaining a PMA supplement”); Weaver v. Ethicon, Inc., 2016 U.S. Dist. Lexis 169592, at *9 (S.D. Cal. Dec. 6, 2016) (“the [device] underwent a rigorous review process and obtained premarket approval . . . and underwent supplemental, re-evaluation and re-approval twenty eight times”); Grubbs v. Synthes, 2016 U.S. Dist. Lexis 12805, at *6 (M.D. Fla. Jan. 19, 2016) (“supplemental premarket approval from the FDA [is] subject to similar criteria as the initial application for premarket approval”) (citation omitted); Mink v. Smith & Nephew, Inc., 145 F. Supp.3d 1208, 1214 (S.D. Fla. 2015) (“‘All procedures and actions that apply to a PMA application . . . also apply to PMA supplements except that the information required in a supplement is limited to that needed to support the change.’”) (quoting 21 C.F.R. §814.39(c)); Millman v. Medtronic, 2015 U.S. Dist. Lexis 21750, at *8 (D.N.J. Feb. 24, 2015) (“The PMA Supplement is subject to the same rigorous standards of review as an initial PMA application”) (citation omitted); Waltenburg v. St. Jude Medical, Inc., 33 F. Supp.3d 818, 834 (W.D. Ky. 2014) (“the PMA Supplements for the [device] supplemented, rather than supplanted, the PMA requirements for its predecessor”) (emphasis original); Bertini v. Smith & Nephew, Inc., 8 F. Supp.3d 246, 253, 260 (E.D.N.Y. 2014) (“FDA approved the [device’s] design for safety and effectiveness when it allowed defendant to sell the liner after the liner went through the supplemental PMA process”); Blankenship v. Medtronic, Inc., 6 F. Supp.3d 979, 986 (E.D. Mo. 2014) (“Because the . . . device received pre-market approval from the FDA, as well as supplemental approvals, the federal government has established requirements in regards to the . . . device.”) (citations omitted); Toubian v. Boston Scientific Corp., 2014 U.S. Dist. Lexis 195963, at *8 (C.D. Cal. Aug. 19, 2014) (because the device “was approved by the FDA . . . as part of a supplemental premarket approval application . . . the federal government has established requirements applicable to [it]”) (citations omitted); Burkett v. Smith & Nephew GmbH, 2014 U.S. Dist. Lexis 43995, at *8 (E.D.N.Y. March 31, 2014) (“a manufacturer must receive supplemental PMA from the FDA for any changes, and the FDA evaluates the proposed changes “under largely the same criteria as an initial application’”) (quoting Riegel); Starks v. Coloplast Corp., 2014 U.S. Dist. Lexis 19611, at *14 (E.D. Pa. Feb. 13, 2014) (“[s]everal supplemental premarket approval applications” demonstrated that “the federal government has imposed device-specific ‘requirements’ on the . . . implant”); Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *1 (W.D. Pa. Sept. 19, 2013) (defendant “did obtain supplemental approval . . . [t]herefore, . . . the Court finds that the preemption provisions of the MDA apply”); Duggan v. Medtronic, Inc., 840 F. Supp.2d 466, 472 (D. Mass. 2012) (rejecting attack on sufficiency of PMA supplement; “The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval”); Bentzley v. Medtronic, Inc., 827 F. Supp.2d 443, 447, 451 (E.D. Pa. 2011) (supplemental PMA approval is “evidence” that the device “received the more-rigorous premarket approval from the FDA”); Godfrey v. Advanced Neuromodulation Systems, Inc., 2011 U.S. Dist. Lexis 155106, at *28-29 (W.D. La. April 1, 2011) (“any state law claim based on an allegation that a supplemental PMA device is unreasonably dangerous in construction or composition because it deviates from an earlier PMA version of the device is preempted”); Franklin v. Medtronic, Inc., 2010 U.S. Dist. Lexis 71069, at *2 n.1 (Mag. D. Colo. May 12, 2010) (“a PMA Supplement is not any less extensive than an Original PMA Application”), adopted, 2010 U.S. Dist. Lexis 61889 (D. Colo. June 22, 2010); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1150 (D. Minn. 2009) (an “application for supplemental PMA . . . is evaluated “under largely the same criteria as an initial application”) (quoting Riegel), aff’d, 623 F.3d 1200, 1203 (8th Cir. 2010); Rattay v. Medtronic, Inc., 482 F. Supp.2d 746 (N.D.W. Va. 2007) (the device “was approved through a PMA supplement instead of an original PMA submission.  That distinction, however, is irrelevant to the [preemption] questions at hand.”); Hughes v. Cook, 452 F. Supp.2d 832, 841 (W.D. Tenn. 2006) (“the [device’s] PMA Supplement approval constitutes FDA approval of the product’s design, testing, intended use, manufacturing methods, performance standards and labeling and is specific to the product, i.e., the FDA has imposed device-specific federal requirements”) (citation and quotation marks omitted); McMullen v. Medtronic, Inc., 2004 U.S. Dist. Lexis  22819, at *8 (S.D. Ind. Sep. 15, 2004) (“The procedures applicable to a PMA Supplement are the same as those applicable to an original PMA, although the FDA only requires the manufacturer to provide that information necessary to support the proposed modifications.”) (citation omitted), aff’d, 421 F.3d 482 (7th Cir. 2005); Steele v. Depuy Orthopaedics, Inc., 295 F. Supp.2d 439, 453 (D.N.J. 2003) (“the FDA’s approval of the PMA supplement for the [device] imposes specific requirements on that device sufficient to trigger preemption”); Enlow v. St. Jude Medical, Inc., 210 F. Supp.2d 853, 858 (W.D. Ky. 2001) (applicable FDA requirements “consist[] of the totality of the design, manufacturing processes, and labeling . . . as found in the entire relevant PMA and accompanying PMA Supplements”) (citation and quotation marks omitted); In re Medtronic Polyurethane Insulated Pacing Lead Product Liability Litigation, 96 F. Supp.2d 568, 570 (E.D. Tex. 1999) (“for purposes of a preemption analysis of claims related to the [device], there is no difference between the PMA process and the PMA Supplement process”); Isbell v. Medtronic, Inc., 97 F. Supp.2d 849, 851 (W.D. Tenn. 1998) (“The procedures applicable to a PMA supplement are the same as those applicable to an original PMA, although the information required is limited to that necessary to support the proposed modifications.”) (citation omitted).

Finally, a number of state trial court decisions have also held that there is no difference between PMA approval and PMA supplement approval for the purpose of PMA preemption:  Rieger v. Medtronic MiniMed, Inc., 2025 Cal. Super. Lexis 14, at *25 (Cal. Super. Jan. 28, 2025) (rejecting plaintiff’s argument that a PMA supplement “never received the rigorous scrutiny required for PMA” as unsupported by any authority and improperly seeking to “review the rigor of the FDA’s approval process”); Delfino v. Medtronic, Inc., 2018 Minn. Dist. Lexis 428, at *5 (Minn. Dist. May 18, 2018) (“A PMA Supplement is subject to the same rigorous standards of review as an initial PMA application.”) (citations omitted), aff’d, 2019 Minn. App. Unpub. Lexis 530, at *12 (Minn. App. June 10, 2019) (“the FDA evaluates” “a PMA supplement . . . under the same rigorous standards of review as an initial application”); McDonald v. Lester E. Cox Medical Centers, 2014 WL 58773, at *2 (Mo. Cir. Jan. 2, 2014) (“Supplemental PMA or PDP applications are subject to the same rigorous standards of review as initial PMA or PDP applications.”); Risavich v. Heart Rhythm Consultants, 2010 N.Y. Misc. Lexis 6835, at *8 (N.Y. Sup. Feb. 1, 2010) (an “application for supplemental premarket approval [is] evaluated under largely the same criteria as an initial applications”) (citation omitted); In re Medtronic Sprint Fidelis Lead Products Liability State Court Litigation, 2009 WL 3417867, at *33 (Minn. Dist. Oct. 20, 2009) (“the design, manufacturing, labeling, and marketing standards applicable to a device set forth in a PMA application (or PMA Supplement) that has been approved by the FDA constitute federal ‘requirements’ for purposes of preemption”); id. at *34 n.11 (rejecting argument that PMA supplements were “less than rigorous” and that their preemptive effect “should be lessened”).

Thus, the new case that Law 360 thought was sufficiently interesting to feature isn’t really new at all.  Ever since Riegel (and even before) plaintiffs have tried, and failed, to denigrate FDA approvals of PMA supplements as somehow less preemptive than original FDA PMA approvals – and failed miserably.