D.C. Court of Appeals Sidesteps Issue of FDA Classification of Dental Amalgam Devices

April 24, 2007

On April 13, 2007, the U.S. Court of Appeals for the District of Columbia ruled in Moms Against Mercury v. FDA that the court lacks subject matter jurisdiction to decide whether FDA should classify “pre-amendment” Encapsulated Amalgam Alloy and Dental Mercury (“EAADM”) devices.  The Petitioners, four organizations representing the economic, health, and environmental interests of their members and the public generally, and five individuals, contend that FDA’s decision not to classify EAADM violates the FDC Act.  They petitioned the court in April 2006 to order FDA to classify EAADM, and to remove the medical device from the market until the Agency has made a classification decision. 

The FDC Act, as amended by the 1976 Medical Device Amendments, authorizes FDA to regulate medical devices.  FDA regulates devices by placing them into one of three classes on the basis of the controls necessary to reasonably assure their safety and effectiveness. Class I or II devices require the manufacturer to submit a premarket notification (i.e., a 510(k)) requesting permission for commercial distribution. Class III devices, which are deemed by FDA to pose greater risk than Class I and II devices, require FDA approval of a Premarket Approval (“PMA”) application. Pre-amendment devices refer to devices legally marketed in the United States before the enactment of the 1976 Medical Device Amendments (i.e., May 28, 1976) that have not been significantly changed or modified since then, and for which a regulation requiring a PMA application has not been published by FDA.  Pre-amendment devices are considered to be “grandfathered” devices and do not require a 510(k).

In dismissing the Petitioners’ petition, the court stated:

As to subject matter jurisdiction, FDA’s failure to classify a device does not directly give rise to judicial review in this Court under the FDCA. Under section 360g, persons who are adversely affected by specified FDA regulations or orders may file, in the courts of appeals, a petition for judicial review within thirty days of the relevant FDA action. 21 U.S.C. § 360g(a). Specifically, petitioners invoke provisions authorizing this Court’s review of three FDA decisions: (1) subjecting a device to pre-market approval under subsection (a)(4); (2) determining that a post-amendment device is substantially equivalent to a pre-amendment device under subsection (a)(8); and (3) reclassifying a device from one class to another under subsection (a)(9). As petitioners concede, however, the FDA has engaged in none of these actions with regard to EAADM.  These provisions thus cannot support jurisdiction in this Court.

Shortly after the court issued its ruling, Petitioners’ counsel sent a letter to FDA stating that “FDA’s policy on mercury amalgam is legally unsustainable, intellectually indefensible, and morally unconscionable,” and that FDA “needs to choose between (1) compliance with the law vs. covering for errant colleagues, (2) children’s health vs. dentist economics, and (3) the integrity of an agency committed to ending mercury vs. special privileges accorded a mercury-using special interest group by the Center for Devices.” 

It has been reported that a second lawsuit against FDA is in the works, this time calling for EAADM to be permanently removed from the market.  Congress might also hold hearings on the health risks associated with EAADM, and Representatives Dan Burton (R-IN) and Diane Watson (D-CA) reportedly plan to reintroduce legislation that would phase-out dental amalgams.


Categories: Medical Devices