Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

United States v. 2035 Inc.

United States District Court, D. South Dakota, Western Division

October 13, 2015

UNITED STATES OF AMERICA, Plaintiff,
v.
2035 INC., a corporation, and ROBERT L. LYTLE, an individual, d/b/a 2035 PMA and QLASERS PMA, Defendants.

AMENDED ORDER OF PERMANENT INJUNCTION (GRAMMATICAL AND NON-SUBSTANTIVE REVISIONS ONLY)

JEFFREY L. VIKEN CHIEF JUDGE

The Court held a hearing on Plaintiff’s Motion for Preliminary Injunction on November 17, 2014, and entered a preliminary injunction on January 14, 2015 against 2035 Inc., a corporation, and Robert L. Lytle, an individual, who also goes by the name Dr. Larry Lytle and does business as 2035 PMA and QLasers PMA (collectively, “Defendants”). (Docket 48). On March 3 and 4, 2015, the court held a trial on the merits. Having considered all arguments raised at the preliminary injunction hearing, trial, and in the entire record in this case, the court finds that Defendants violated the Federal Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. § 301 et seq., and finds that Defendants, unless restrained by order of this court, will continue to violate the FDCA. The parties to this action stipulate that the court shall enter this order of permanent injunction. Pursuant to 21 U.S.C. § 332(a), Fed.R.Civ.P. 65 and the inherent equitable authority of the court, it is ORDERED as follows:

1. This Court has jurisdiction over the subject matter of this action and has personal jurisdiction over all parties to this action pursuant to 28 U.S.C. §§ 1331 and 1345 and 21 U.S.C. § 332.

2. The Complaint states a cause of action against Defendants under the FDCA, 21 U.S.C. § 301 et seq.

3. Defendants violated the FDCA, 21 U.S.C. § 331(a), by introducing or delivering for introduction into interstate commerce and/or causing the introduction or delivery for introduction into interstate commerce of articles of device, as defined by 21 U.S.C. § 321(h), that were adulterated within the meaning of 21 U.S.C. § 351(f)(1)(B).

4. Defendants violated the FDCA, 21 U.S.C. § 331(a), by introducing or delivering for introduction into interstate commerce and/or causing the introduction or delivery for introduction into interstate commerce of articles of device, as defined by 21 U.S.C. § 321(h), that were misbranded within the meaning of 21 U.S.C. § 352(o).

5. Defendants violated the FDCA, 21 U.S.C. § 331(a), by introducing or delivering for introduction into interstate commerce and/or causing the introduction or delivery for introduction into interstate commerce of articles of device, as defined by 21 U.S.C. § 321(h), that were misbranded within the meaning of 21 U.S.C.§ 352(a).

6. Defendants violated the FDCA, 21 U.S.C. § 331(a), by introducing or delivering for introduction into interstate commerce and/or causing the introduction or delivery for introduction into interstate commerce of articles of device, as defined by 21 U.S.C. § 321(h), that were misbranded within the meaning of 21 U.S.C. § 352(j).

7. Defendants violated the FDCA, 21 U.S.C. § 331(k), by causing articles of device to become adulterated within the meaning of 21 U.S.C. § 351(f)(1)(B) and misbranded within the meaning of 21 U.S.C. §§ 352(o), (a), and (j), while such devices were held for sale after shipment of one or more of their components in interstate commerce.

8. Upon entry of this Order, Defendants and each and all of their directors, officers, agents, representatives, employees, attorneys, successors, and assigns, and any and all persons in active concert or participation with any of them (including franchisees, affiliates, private membership associations, and “doing business as” entities, and all persons or entities engaged in any part of the manufacture, design, processing, packing, labeling, holding, storing, and/or distribution of Defendants’ devices, hereinafter collectively referred to as “Associated Persons”), who have received actual notice of the contents of this Order by personal service or otherwise, are hereby restrained and enjoined from directly or indirectly manufacturing, designing, processing, packing, labeling, holding, and/or distributing any article of device at or from 2035 1st Avenue, Rapid City, South Dakota, 3312 Jackson Boulevard, Rapid City, South Dakota, and/or 3939 Canyon Lake Drive, Suite A, Rapid City, South Dakota, or at or from any other locations at which Defendants, now or in the future, directly or indirectly manufacture, design, process, pack, label, hold, and/or distribute devices unless and until:

A. Each of Defendants’ devices are either: (1) the subject of an approved application for premarket approval under 21 U.S.C. § 360e(a); (2) the subject of an investigational device exemption under 21 U.S.C. § 360j(g); or (3) the subject of a cleared premarket notification under 21 U.S.C. § 360(k) for each of their intended uses;
B. Defendants select and retain at their expense an independent person or persons (the “Expert”) to conduct comprehensive inspections of Defendants’ operations and certify in writing to FDA: (1) that he or she has inspected Defendants’ facilities and identified all devices manufactured and/or distributed by Defendants; (2) that each of Defendants’ devices are either the subject of an approved application for premarket approval under 21 U.S.C. § 360e(a), the subject of an investigational device exemption under 21 U.S.C. § 360j(g), or the subject of a cleared premarket notification under 21 U.S.C. § 360(k); (3) that Defendants have corrected all violations set forth in FDA’s Inspectional Observations (“Forms FDA-483”) from all prior FDA inspections since 2001 and the March 3, 2011 Warning Letter; and (4) whether, based upon the Expert’s inspection, Defendants are operating in conformity with the FDCA, applicable regulations, and this Order. The Expert shall be qualified by education, training and experience to conduct such inspections, and shall be without personal or financial ties (other than a consulting agreement with Defendants) to Defendants’ officers or employees or their immediate families. Defendants shall notify FDA in writing of the identity of the Expert within ten (10) business days of retaining such Expert;
C. Defendants report to FDA in writing the actions that they have taken to: (1) correct all violations brought to Defendants’ attention by the Expert and/or set forth in FDA’s Forms FDA 483 from all prior FDA inspections since 2001 and the March 3, 2011 Warning Letter; and (2) ensure that each of Defendants’ devices is the subject of an approved application for premarket approval pursuant to 21 U.S.C. § 360e(a), the subject of an effective investigational device exemption pursuant to 21 U.S.C. § 360j(g), or the subject of a cleared premarket notification pursuant to 21 U.S.C. § 360(k);
D. Defendants recall and destroy, under FDA’s supervision, all devices manufactured, processed, packed, labeled, held, and/or distributed during the time period beginning June 30, 2001, through and including the date of entry of this Order. Defendants shall bear the costs of destruction and the costs of FDA’s supervision. Defendants shall not dispose of any such products in a manner contrary to the provisions of the FDCA, any other ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.