ELECTROMEDICAL PRODUCTS INTERN., INC. v. KESSLER

Civil No. 96-2673 (TPJ).

949 F.Supp. 30 (1997)

ELECTROMEDICAL PRODUCTS INTERNATIONAL, INC., et al., Plaintiffs, v. David KESSLER, Commissioner, U.S. Food and Drug Administration, et al., Defendants.

United States District Court, District of Columbia.

January 10, 1997.


Attorney(s) appearing for the Case

Daniel Gordon Jarcho, McKenna & Cuneo, L.L.P., Washington, DC, for Plaintiffs.

Drake Stephen Cutini, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, for Defendants.


MEMORANDUM AND ORDER

JACKSON, District Judge.

I.

Plaintiffs Electromedical Products International ("EPI") and Lawrence Paros have marketed a controversial medical device, known as a "cranial electrotherapy stimulator" (or "CES"), for many years.1 Under the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., medical devices are assigned to one...

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