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United States v. Undetermined Quantities of Boxes of Articles of Device

May 30, 2007

RE: UNITED STATES
v.
UNDETERMINED QUANTITIES OF BOXES OF ARTICLES OF DEVICE, ET AL.



The opinion of the court was delivered by: William J. Martini Judge

LETTER OPINION

Dear Counsel:

Presently before the Court is Claimant Shelhigh, Inc.'s ("Shelhigh"), motion to release certain seized items intended for export to Italy and Spain. Also before the Court is Shelhigh's motion to release all seized component parts. Plaintiff United States (the "Government") opposes both motions. For the following reasons, Shelhigh's motions are DENIED.

BACKGROUND

On April 16, 2007, the Government filed a Complaint seeking forfeiture in rem of certain undetermined quantities of articles of device. The articles of device consisted of cardiovascular, neurological, and general surgery sterile implantable medical devices, including pulmonic and aortic heart valves and pericardial patches that are surgically implanted in patients. The Complaint sought seizure and condemnation of the devices under 21 U.S.C. § 334. In their Complaint, the Government claims that the articles of device are "adulterated" under 21 U.S.C. § 351(h) because the methods and facilities used for their manufacture, packaging, storage, and installation are not in conformity with current good manufacturing practice requirements ("CGMP") under the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301-99, and its "Quality System" ("QS") regulations, 21 C.F.R. part 820, et seq.

On April 17, 2007, the Court issued a warrant for arrest in rem of the articles of device. The Government then seized Shelhigh's entire inventory of implantable medical devices, including component parts. On May 4, 2007, Shelhigh filed an emergency motion for an expedited order to show cause why certain devices should not be released for export to Italy and Spain. The Court granted Shelhigh's request on May 7, 2007.

In their motion, Shelhigh argues that fourteen specific articles of device should be released by the Government for export to Italy and Spain. Shelhigh claims that these devices need not meet the CGMP requirements if they meet the requirements under 21 U.S.C. § 381(e)(1). In addition, in a separately filed motion, Shelhigh asks the Court to order the release of all components seized by the Government. Shelhigh contends that such components are exempted from the CGMP requirements. The Government opposes both requests. Shelhigh's motions are now before the Court.

DISCUSSION

I. Release of Articles of Device Intended for Export Only Congress enacted the FDCA in 1938.

It prohibits "the introduction or delivery for introduction into interstate commerce of any ... device ... that is adulterated...." 21 U.S.C. § 331. A device is "adulterated" if:

[T]he methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under [21 U.S.C. § 360j(f)(1)]....

21 U.S.C. § 351(h). Section 360j(f)(1) provides that the FDA may promulgate regulations concerning CGMP. Id. § 360j(f)(1)(A). The QS Regulations, found at 20 C.F.R. part 820, embody that effort.

A device intended for export, though, is not deemed adulterated if it meets the requirements of 21 U.S.C. § 381. Specifically, § 381(e)(1) provides that:

[A] ... device ... intended for export shall not be deemed to be adulterated ... if it: (A) accords to the specifications of the foreign purchaser; (B) is not in conflict with the laws of the country to which it is intended for export; (C) is labeled on the outside of the shipping package that it is ...


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