Int'l Acad. of Oral Med. & Toxicology v. U.S. Food & Drug Admin., Civil Action No. 14-356 (JEB)

CourtUnited States District Courts. United States District Court (Columbia)
Writing for the CourtJAMES E. BOASBERG United States District Judge
PartiesINTERNATIONAL ACADEMY OF ORAL MEDICINE & TOXICOLOGY, et al., Plaintiffs, v. THE U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants.
Docket NumberCivil Action No. 14-356 (JEB)
Decision Date01 July 2016

INTERNATIONAL ACADEMY OF ORAL MEDICINE & TOXICOLOGY, et al., Plaintiffs,
v.
THE U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants.

Civil Action No. 14-356 (JEB)

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

July 1, 2016


MEMORANDUM OPINION

Dental amalgam is a metallic compound that dentists use to fill cavities and repair structural deformities in teeth. One of its constituent parts is mercury. The Plaintiffs in this suit, which include a number of individuals and several not-for-profit organizations, fear that mercury renders the compound physically harmful, both for the individuals obtaining fillings and for the dentists responsible for installing and removing them. They are also concerned that the removal of such fillings (also known as silver fillings) may cause environmental harm, as they assert that dental-amalgam particulate travels from patients' mouths to sinks and then to sewers, ultimately contaminating the nation's water supply.

Hoping to take a large bite out of the prevalence of dental amalgam, some of the Plaintiffs asked the Food and Drug Administration to either ban it outright or classify it as high risk, thereby triggering a greater degree of regulatory scrutiny. The FDA rejected these various entreaties. Plaintiffs then brought suit here, asking this Court to compel the FDA to take a considerably stronger regulatory position, including conducting an evaluation of amalgam's

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environmental impact. Before getting to the root of Plaintiffs' claim, however, the Court must determine whether they have standing to sue. Concluding that they do not, the Court will grant Defendants' Motion to Dismiss.

I. Background

As the FDA's duties play an important role in this suit, the Court will first summarize the agency's responsibility for regulating dental devices and set out the regulatory history of dental amalgam. It will then recount the various efforts taken by some of the Plaintiffs to seek recourse directly from the FDA and end with a summary of the case's procedural history, including events that transpired subsequent to the filing of the Complaint.

A. Statutory Framework

Ever since passage of the 1976 Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA), see Pub.L. No. 94-295, 90 Stat. 539 (1976), the FDA has had authority to regulate devices that, among other things, are "intended to affect the structure or any function of the body of man." 21 U.S.C. § 321(h)(3). Under the statute, any device may be categorized into one of three classes: I, II, or III. "A device's classification is determined based on 'the degree of regulation thought necessary to provide reasonable assurance of each device's "safety and effectiveness."'" Ivy Sports Med., LLC v. Burwell, 767 F.3d 81, 83 (D.C. Cir. 2014) (quoting Contact Lens Manufacturers Association v. FDA, 766 F.2d 592, 594 (D.C. Cir. 1985), itself quoting 21 U.S.C. § 360c). Pursuant to the MDA, the FDA has classified a variety of tools and materials used in dentistry as "devices." See generally 21 C.F.R. Part 872 (1988).

The minutiae of the classification regime are immaterial for present purposes, and it is sufficient to explain that "Class I and II devices are considered to pose fewer risks," Ivy Sports Med., 767 F.3d at 83, meaning they demand fewer and less taxing regulatory controls. "The

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devices receiving the most federal oversight," in contrast, "are those in Class III," which consist of "devices that present great risks [but] nonetheless offer great benefits in light of available alternatives." Riegel v. Medtronic, Inc., 552 U.S. 312, 317, 318 (2008).

Class I devices are regulated by the imposition of "'general controls,' such as labeling requirements." Id. at 316. Class II devices are, in addition to "general controls," subject to "'special controls' such as performance standards and postmarket surveillance measures." Id. at 316-17. Finally, Class III devices require rigorous pre-market evaluations and assessments to determine the product's safety, see id. at 317, and to ensure that the device "be made with almost no deviations from the specifications [furnished in the device's] approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness." Id. at 323.

B. Dental Amalgam

"Dental amalgam" is a single device, but it is made up of two component parts, both of which are FDA-regulated devices in their own right: (a) elemental or "dental" mercury, and (b) amalgam alloy, which is mostly composed of silver, tin, and copper. See Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy, 74 Fed. Reg. 38686, 38696 (Aug. 4, 2009). Manufacturers of dental amalgam prepare and sell pre-dosed capsules containing those two components, which allows a dentist to mix them together in her office when installing a filling. See id. at 38696. The FDA formerly referred to this composite device as "encapsulated amalgam alloy and dental mercury," 67 Fed Reg. 7620, 7621 (Feb. 20, 2002), but it is now known more pithily as "dental amalgam." 74 Fed. Reg. at 38686.

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Shortly after Congress enacted the MDA in the late 1970s, the FDA began the process of classifying the two sub-components of dental amalgam separately. See Classification of Dental Devices; Development of General Provisions, 45 Fed Reg. 85962 (Dec. 30, 1980) (Proposed Rule). In 1987, the agency promulgated a final rule classifying elemental mercury - then known as "dental mercury" - as a Class I device, and amalgam alloy as a Class II device. See Dental Devices; General Provisions and Classifications of 110 Devices, 52 Fed. Reg. 30082, 30084-85 (Aug. 12, 1987).

Unfortunately, "[d]ue to an inadvertent error," the FDA neglected to propose classification of the combined form, dental amalgam, in the 1980s rulemaking process. See 67 Fed. Reg. at 7621. It nevertheless decided at that time to treat dental amalgam as a Class II device, since one of its components, amalgam alloy, was regulated as Class II, even though the remaining components were regulated as Class I. See id.; 52 Fed. Reg. at 3099, 30102; see also Moms Against Mercury v. FDA, 483 F.3d 824, 825 (D.C. Cir. 2007) (recounting history of dental amalgam); Comm. of Dental Amalgam Mfrs. & Distributors v. Stratton, 92 F.3d 807, 811 (9th Cir. 1996) (recognizing and approving FDA's treatment of dental amalgam as a regulated device even though it had not been classified separately from its "component parts" dental mercury and amalgam alloy).

C. Plaintiffs' Citizen Petitions

Plaintiffs comprise a hodgepodge of individuals and organizations, all of whom in some way oppose the use of mercury in dental fillings. The Court will not provide extensive details on these various entities and individuals until later in this Opinion, as the briefing has clarified that only a subset of the full list of Plaintiffs possesses a colorable argument that they have standing to sue. Suffice it to say that at various points in the recent past, certain members of the present

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group of Plaintiffs - which includes both natural persons and organizations - have attempted to steer the FDA away from using mercury in fillings.

The prologue to the present suit began in the 1990s, when various individuals and organizations (including some named Plaintiffs here) filed what are known as "Citizen Petitions" with the FDA asking it to reconsider its treatment of dental amalgam. See Mot. at 4-5; 21 C.F.R. § 10.25(a) ("An interested person may petition the Commissioner [of the FDA] to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action . . . (2) in the form for a citizen petition in § 10.30."). The Petitions prompted the agency to consult with the Dental Products Panel of the Medical Devices Advisory Committee, after which it issued a notice of proposed rulemaking in 2002, suggesting that it would formally classify dental amalgam as Class II. See 67 Fed. Reg. at 7624.

Although the 2002 proposed rule marked the beginning of the FDA's notice-and-comment process, some of the Plaintiffs named here believed the agency was moving too slowly. They filed two separate lawsuits to force the FDA to take final action. The first was an unsuccessful direct petition to the D.C. Circuit in 2006. See Moms Against Mercury, 483 F.3d at 824. The second was a district-court case initiated in 2007. See Moms Against Mercury v. Eschenbach, No. 07-2332 (D.D.C.). In settling the latter, the FDA agreed to issue a Final Rule classifying dental amalgam by July 28, 2009, see Mot. at 6, which set the stage for the instant dispute.

The first action relevant here came just days before the FDA was scheduled to publish its Final Rule. On July 25, 2009, a subset of the named Plaintiffs submitted a Citizen Petition asking the FDA to, inter alia, ban dental amalgam or, alternatively, regulate it as a Class III device. See Mot., Exh. 1 (July 25, 2009, Citizen Petition) at 1. The Petition also included less-

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desirable alternatives in the event the device remained as Class II, such as restricting its use in various subpopulations (like young children and pregnant women). It also asked the FDA to require manufacturers to prepare environmental assessments. Id.

The stipulated deadline came and went with no news from the FDA. But in early August 2009, the agency finally published its Final Rule in which it formally classified dental amalgam as a Class II device. See 74 Fed. Reg. 38686 (Aug. 4, 2009) (Final Rule). In doing so, it addressed safety concerns raised in the voluminous submissions received during the seven-year notice-and-comment process, concluding that Class II special controls would properly balance any potential health risks against the device's benefits. See 74 Fed. Reg. at 38686-87. It also addressed...

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