Court Opinion

ID: 6932626
Source: CourtListenerOpinion
Date Created: 2022-07-24 00:12:05.414292+00
Date Added: 2024-06-11T16:07:16.569371
License: Public Domain

LOKEN, Circuit Judge,
concurring, with whom Judge FAGG joins.
I concur in all of Judge Heaney’s thorough and well-reasoned opinion except parts III.A.2. and III.B. My disagreement with those portions of Judge Heaney’s analysis is narrow but significant. ‘ In my view, FDA has determined that Kimberly-Clark’s tampon package labels comply with the applicable federal regulation, 21 C.F.R, § 801.430. Therefore, National Bank’s state law claims for failure to comply with this FDA regulation are preempted. See King v. Collagen Corp., 983 F.2d 1130, 1135-36 (1st Cir.), cert. denied, — U.S. —, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993).
FDA has classified menstrual tampons as Class II medical devices. See 21 C.F.R. §§ 884.5460, 884.5470. Class II devices are those which require “special controls” such as performance standards, in addition to the general controls applicable to .Class I devices, in order “to provide reasonable assurance of the safety and effectiveness of the device.” 21 U.S.C. § 360c(a)(l)(B). The only special control that FDA has adopted for menstrual tampons is its “user labeling” regulation, 21 C.F.R. § 801.430.
In October 1989, FDA significantly amended § 801.430 to adopt a standardized method of expressing product absorbency on tampon package labels, a disclosure the agency considers essential to safe use of these products. In promulgating this amendment, FDA declared, “Any menstrual tampon that is not labeled as required by the final rule and that is initially introduced or initially delivered for introduction into commerce after March 1, 1990, is misbranded under sections 201(n) and 502(a) and (f) of the act.” 54 Fed.Reg. 43766, 43770 (Oct. 26, 1989).
Kimberly-Clark promptly prepared new package labels to comply with these additional disclosure requirements and submitted the new labels to FDA in a “510(k) Premarket Notification Submission.” This is the procedure by which the manufacturer of a new medical device may receive expedited FDA permission to bring the device to market by demonstrating that it is “substantially equivalent” to an existing Class I or Class II device from the standpoint of safety and effectiveness. See 21 C.F.R. § 807.81. In addition, when a manufacturer modifies a Class I or Class II device already on the market in a way that significantly affects its safety or effectiveness, it must file a new 510(k) submission. See 21 C.F.R. § 807.81(a)(3) (iii). That was obviously the basis upon which Kimberly-Clark submitted its new tampon package labels following FDA adoption of the amendments to § 801.430. ■
In the case of most 510(k) submissions, the applicant is required to submit copies of its proposed labels so that FDA can determine the new device’s intended use, a critical part of the “substantially .equivalent” inquiry. See 21 C.F.R. §§ 807.87(e), 807.100(b)(1). For that reason, an FDA order permitting the new device to be marketed as substantially equivalent to existing devices would not normally reflect agency approval of the submitted labels. In this case, however, the “special control” adopted by FDA for this Class II device is a labeling requirement, and Kimberly Clark’s 510(k) submission was for the specific purpose of allowing the agency a premarket review of new labels intended to satisfy its newly-amended safety regulation.
In these circumstances, the specific procedure followéd by FDA in reviewing Kimberly-Clark’s 510(k) submission demonstrates that the agency approved the proposed new labels. Agency staff met with Kimberly-Clark representatives to review the proposed labels and requested modifications. Kimberly-Clark then submitted revised labels incorporating FDA’s requested changes, following which the agency sent Kimberly-Clark a form letter stating that “the device is substantially equivalent to devices marketed in interstate commerce.... You may, therefore, market the device.” Of course, the device was already being marketed; the only safety-related change was to the labeling, in response to FDA’s amended regulation. Thus, the agency’s finding of substantial equivalence necessarily reflected a determi*999nation that the labels comply with § 801.430, as amended.
If Kimberly-Clark’s tampon packaging does not conform to FDA’s labeling regulation, the product is “misbranded.” See 21 U.S.C. § 352; 21 C.F.R. § 801.430(h). Thus, when new labels were submitted to the agency under its premarket notification submission procedure after § 801.430 was amended, the FDA would have been in dereliction of its statutory duty to prevent medical device mis-branding if it had permitted Kimberly-Clark to bring those labels to market without determining that they comply with the new regulation. That FDA gave its permission in a form letter that included the standard non-approval language relied upon by Judge Hea-ney — language that reflects another of the agency’s regulations, see 21 C.F.R. § 807.97 — cannot in my view obscure the obvious fact that, as the district court found, FDA did in fact determine that Kimberly-Clark’s labels comply with § 801.430. Therefore, all of National Bank’s claims for inadequate labeling or failure to warn are preempted.