CourtListener is a project of Free Law Projecta federally-recognized c 3 non-profit. We rely on donations for our financial security. Bildsten and Friedrich A. Foster and Lousene M. Daffer, and Ronald Berglund collectively, "defendants" reached an agreement on a permanent injunction that had been sought by the United States to bar defendants from selling certain products in interstate commerce. The resultant consent decree allowed defendants to continue exporting products subject to conditions imposed by the Food Sybaritic inc fdating Drug Administration "FDA".
After an inspection of defendants' facilities, approximately ten months later, the FDA issued a cessation order on further exports. Defendants moved to vacate the cessation order or, alternatively, to modify or dissolve the consent decree. Because the Court finds that the government's action does not constitute arbitrary and capricious action, the Court will not vacate the order.
Further, since defendants have not met their burden to warrant relief from the requirements of the consent decree, the Court declines to either modify or vacate the consent decree.
Defendants market products Sybaritic inc fdating aesthetics and fitness including cosmetics, skin care products, and spa capsules. The FDA conducted inspections of defendants' operation beginning in May and continuing through March The investigators concluded that many of Sybaritic's products were adulterated and misbranded in violation of 21 U.
The parties stipulated that the Sybaritic inc fdating decree should be considered a final judgment of the Court. The consent decree contains three paragraphs important to the disposition of the instant motion, paragraphs 9, 10, and Paragraph 9, enjoins defendants from "directly or indirectly designing, manufacturing, processing, packing, repacking, labeling, holding, distributing, importing or exporting from the United States of America, any device There is an exemption, however, for "any device manufactured, processed, packaged, labeled, held for sale, or introduced into interstate commerce solely for export from the United States, provided that the applicable requirements of 21 U.
Paragraph 10, requires defendants to notify the FDA in writing of their intent to "commence designing, manufacturing, or distributing any device" and demonstrate that the is in compliance with certain FDA regulations. The consent decree also gives the FDA the right to inspect and to impose liquidated damages for violations. In Marchthe FDA inspected defendants' Sybaritic inc fdating and determined that defendants were in violation of the consent decree due to the export of certain products that did not meet the requirements of 21 U.
The United States issued a cessation order including an assessment of liquidated damages. The cessation order addressed the export of seven devices:. Keyes granted a motion to stay the cessation order pending the outcome of this motion. Defendants move to vacate the cessation order or, alternatively, to modify or dissolve the consent decree.
Paragraph 25 of the consent decree dictates that this Court must review the FDA's cessation order under the standard set forth in 5 U. Ass'n of the U. A court will affirm the agency's findings of fact if they are supported by "substantial evidence. The Sybaritic inc fdating evidence standard is "extremely deferential," and "the agency's findings of fact must be upheld unless the [defendant] Sybaritic inc fdating that the evidence Further, per the consent decree, the court is obliged to evaluate the FDA's decision without taking discovery.
The FDA defines a "device" as an instrument which is. Courts assess whether an instrument is a "device" based on the intended use of the product as determined from its label, accompanying labeling, promotional claims, advertising, and any other relevant source, including consumer intent. United States, F. However, the Court notes that the consent decree contemplated that "Sybaritic inc fdating" decision of the expert would be subject to an audit, indicating that his determination was not final or binding on the FDA.
Therefore, this reasoning is not persuasive. As a result, the Court finds no basis to deviate from the FDA's determination that the products are devices and therefore are covered by the terms of the consent decree. Defendants argue that the meaning of Paragraph 9 H was to allow defendants to continue exporting goods outside of the United States while only complying with the requirements of 21 U. Section e 1 permits the exportation of a Sybaritic inc fdating if it:.
Defendants contend that all of their exportation of goods met these four criteria. The United States asserts that the consent decree calls for exported products to meet the requirements of ewhich necessarily includes both e 1 and e 2. Section e 2 states that "Paragraph 1 does not apply to any [unapproved] device Defendants urge the Court to consider extrinsic evidence of their intent in the phrasing of this paragraph, arguing they would have never entered into the decree had they thought this meaning would be applied to Paragraph 9 H.
However, the parties were represented by lawyers who were certainly capable of creating a document that memorialized the parties' intent. Further, the Court declines to evaluate extrinsic evidence based on Paragraph 25 which directs the Court to review only "the written record before the FDA at the time" the cessation order was issued. The language contains no limitation on which parts of that section apply.
Defendants next argue that strict enforcement of the requirements of 21 U. Defendants concede they have not met CGMP requirements. Therefore, they argue Sybaritic inc fdating application of these requirements here constitutes a position contrary to Sybaritic inc fdating practice and as such the Court should find it to be arbitrary and capricious.
As devices that were marketed after the enactment of the Medical Device Amendments ofthe products at issue are Class III devices.