Ewing v. Mytinger Casselberry

4 Analyses of this case by attorneys

  1. The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not Warranted

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstSeptember 18, 2012

    FDA moved to dismiss the case on several grounds, including lack of standing, lack of ripeness, and failure to exhaust administrative remedies. The D.C. District Court granted FDA’s Motion to Dismiss on various grounds, including that the Warning Letters are not final agency action subject to judicial review under the Administrative Procedure Act (“APA”), and that the holistic candlers’ efforts to obtain injunctive and declaratory relief “is nothing more than a pre-enforcement challenge foreclosed by” the U.S. Supreme Court’s decision in Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950), and is therefore not ripe. The D.C. Circuit affirmed the district court decision, explaining that the Warning Letters are not final agency action because “they neither mark the consummation of the agency’s decisionmaking process nor determine the [Petitioners’] legal rights or obligations.”

  2. Judge Snuffs Out Holistic Candlers Lawsuit; Constitutional Challenge Falls on Deaf Ears

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstMarch 20, 2011

    That’s right, you light it up, and lay on your side, potentially allowing hot wax to drip into your ear, apparently to create negative pressure that supposedly draws wax and debris out of the ear canal.In this case, which we previously posted on, the holistic candlers alleged violations of their First, Ninth, Tenth, and Fourteenth Amendment rights, and sought injunctive relief staying FDA’s determination that their ear candles are unapproved medical devices, as well as declaratory relief voiding FDA’s determination. FDA moved to dismiss the case on several grounds, including lack of standing, lack of ripeness, and failure to exhaust administrative remedies.In addition to ruling that the holistic candlers lacked subject matter jurisdiction (standing, ripeness), Judge Leon ruled that the holistic candlers’ efforts to obtain injunctive and declaratory relief “is nothing more than a pre-enforcement challenge foreclosed by” the U.S. Supreme Court’s 61-year old decision in Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950). Ewing and its progeny established that courts lack jurisdiction to enjoin FDA from initiating enforcement proceedings under the FDC Act.

  3. Cody/Lannett Unapproved Morphine Sulfate Litigation Gets New Legs; But FDA Motion to Dismiss Tries to Pull the Rug Out From Under Them

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstSeptember 6, 2010

    Moreover, the Supreme Court long ago established that courts lack jurisdiction to enjoin FDA’s enforcement proceedings under FDCA, the very relief plaintiffs seek here. See Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950).This Court has no jurisdiction to review unripe, nonfinal agency action or to enjoin a hypothetical enforcement proceeding.

  4. District Court Denies Motion for Temporary Restraining Order and Preliminary Injunction in Marketed Unapproved Morphine Sulfate Oral Solution Case

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstJuly 26, 2010

    That NDA is still under review by FDA.Cody/Lannett argued in their lawsuit that FDA should be enjoined from taking enforcement action after July 24, 2010 if such enforcement action is based on FDA’s contention that Morphine Sulfate Solution Immediate-Release 20mg/mL is an unapproved “new drug,” and that the court should issue a declaratory judgment that FDA violated the Administrative Procedure Act (“APA”) in determining that the product is a “new drug.” Cody/Lannett also alleged that FDA violated the APA by not treating Cody/Lannett fairly in the NDA process.In denying the injunctive and declaratory relief requested by Cody/Lannett, the court relied on the U.S. Supreme Court’s decision in Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950). Ewing and its progeny “established that courts lack jurisdiction to enjoin FDA from initiating enforcement proceedings under the FDCA.”