Searching over 5,500,000 cases.

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

January 14, 2015

2035 INC., a corporation, and ROBERT L. LYTLE, an individual, d/b/a 2035 PMA and QLASERS PMA, Defendants.


JEFFREY L. VIKEN, Chief District Judge.


On October 21, 2014, plaintiff United States of America filed a complaint seeking a permanent injunction against the defendants 2035 Inc., a corporation, and Robert L. Lytle, an individual, d/b/a 2035 PMA and QLASERS PMA, for alleged violations of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 332 et seq . ("FDCA"). (Docket 1). Plaintiff filed a motion for a preliminary injunction to enjoin defendants from violation of the FDCA during the pendency of these proceedings. (Docket 4). On October 23, 2014, the court entered an order setting a hearing on plaintiff's motion for a preliminary injunction and requiring plaintiff to serve a copy of the order and all documents filed in this case on defendants. (Docket 15). On October 29, 2014, the court entered an order requiring the defendants to file a response to plaintiff's motion for preliminary injunction by November 6, 2014. (Docket 23). The order set a hearing on plaintiff's motion for preliminary injunction on November 17, 2014. Id. at p. 3. Defendant Robert L. Lytle filed his response in resistance to plaintiff's motion.[1] (Docket 28). Mr. Lytle also filed motions for a more definite statement as to plaintiff's claims and for an administrative hearing. (Dockets 31 & 32). Defendant 2035 Inc., did not file a response to the plaintiff's motion for a preliminary injunction.[2]

At the November 17, 2014, preliminary injunction hearing, the plaintiff appeared through its attorney, Ross S. Goldstein. Mr. Lytle appeared pro se.[3] The court considered the filings and arguments of the parties. Based on the analysis and findings set out in this order, the court grants the government's motion for a preliminary injunction.



"The district courts of the United States... shall have jurisdiction, for cause shown to restrain violations of section 331 of this title...." 21 U.S.C. § 332(a). Where Congress provided for statutory injunctions to protect the public interest, an equity court has powers broader and more flexible than in a case between private litigants. Mitchell v. Robert D. Mario Jewelry, Inc., 361 U.S. 288, 291 (1960). "Where the plaintiff is a sovereign and where the activity may endanger the public health, injunctive relief is proper, without resort to balancing.'" Illinois v. Milwaukee, 599 F.2d 151, 166 (7th Cir. 1979), rev'd on other grounds, 451 U.S. 304 (1981). In public health legislation, such as the Food, Drug and Cosmetic Act, 21 U.S.C. § 332 et seq . ("FDCA"), the emphasis shifts from irreparable injury to concern for the general public interest. "The United States... is not bound to conform with the requirements of private litigation when it seeks the aid of the courts to give effect to the policy of Congress as manifested in a statute. It is a familiar doctrine that an injunction is an appropriate means for the enforcement of an act of Congress when it is in the public interest." Shafer v. United States, 229 F.2d 124, 128 (4th Cir. 1956). Thus the criteria of Dataphase Systems, Inc. v. C L Systems, Inc., 640 F.2d 109 (8th Cir. 1981) ( en banc ), are not considered.

Rather, when a federal statute, 21 U.S.C. § 332(a), authorizes the district court to enjoin violations of § 331, the government need only show: (1) the statute applies to defendants; and (2) there exists some cognizable danger of recurrent violations. See United States v. W.T. Grant Co., 345 U.S. 629, 633 (1953) (district courts are statutorily vested with the jurisdiction to restrain violations of the legislative acts of Congress).

Mr. Lytle moves for dismissal with prejudice pursuant to Fed.R.Civ.P. 12(b)(2) "for want of personal jurisdiction over" him and Rule 12(b)(6) "for Plaintiff's failure to state a claim upon which relief can be granted." (Docket 28 at p. 2). Mr. Lytle also bases his motion for dismissal on "the Court's Oath of Office; requirement of good Behavior; and Good Faith...." Id . (bold omitted). Mr. Lytle argues "[t]he FDCA regulates the commercial distribution of a device that is intended for human use." Id. at p. 4 (bold omitted). He claims private membership associations and he, individually, are beyond the jurisdiction of the FDCA, the Food and Drug Administration ("FDA"), and the court because "[t]he low-power laser devices manufactured and marketed by Defendants are primarily for peoples' (1) private education, (2) private experimentation and research, (3) for veterinary use on their pets, domestic animals and beasts (see [Docket 28-1]); and (4) for whatever other private use a man or woman who elects to obtain one decides to apply it...." Id . (bold omitted). Mr. Lytle argues "[t]here are no facts or section(s) of the FDCA cited in Plaintiffs pleadings proving that this Court can exert any lawful personal jurisdiction over the private noncommercial distribution activity of Defendants LYTLE, 2035 PMA and QLasers PMA." Id. at p. 5 (bold omitted).

The First Amendment provides protection to Mr. Lytle for embracing and advocating alternative medical treatment. "The First Amendment protects expression, be it of the popular variety or not.... And the fact that an idea may be embraced and advocated by increasing numbers of people is all the more reason to protect the First Amendment rights of those who wish to voice a different view." Boy Scouts of America v. Dale, 530 U.S. 640, 660 (2000). By placing devices and their operational manuals into the stream of commerce, Mr. Lytle goes beyond protection ensured by the First Amendment. Hiding behind a curtain of private membership associations, 2035 PMA and QLaser PMA, does not shield Mr. Lytle from the authority of the FDCA or the jurisdiction of the court.

The court has jurisdiction over the subject matter of this action and has personal jurisdiction over the parties pursuant to 28 U.S.C. §§ 1331 and 1345 and 21 U.S.C. § 332. Mr. Lytle's motion to dismiss for lack of personal jurisdiction is denied.

Conduct of the Defendants

The record discloses Mr. Lytle, [4] both individually and through his private membership associations 2035 PMA and QLasers PMA, and 2035 Inc., have a long history of interaction with the FDA.

Mr. Philips is a FDA Compliance Officer stationed in Minneapolis, Minnesota. (Docket 6 ¶ 1). Mr. Philips provided the following information, under oath, regarding the matters before the court. Id. at p. 11.

Mr. Lytle has been manufacturing and distributing QLaser devices since approximately 1997, and has operated under more than ten different company names. (Docket 6 ¶ 6). He markets the QLaser devices as low level laser therapy devices intended for home use. Id . The QLaser System includes the following devices: the Q10, QI000, Q1000NG, Q1000NG, 660 FlashProbe, 660 Enhancer Probe, 660NG Enhancer Probe, 660NG Enhancer Probe, 808 FlashProbe, 808 Enhancer Probe, 808NG Enhancer Probe, and 808NG Enhancer Probe. Id . ¶ 7. Distributed with QLaser devices is a document captioned "Low Level Laser Application Guide, " which Mr. Lytle authored.[5] Id . ¶ 6.

QLasers PMA distributes QLaser devices nationwide. Id . ¶ 8. In addition, QLasers PMA holds QLaser seminars nationwide, solicits individuals to join defendants' "private membership associations, " and distributes ...

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.