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Lytle v. United States Department of Health and Human Services

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

September 30, 2014

DR. LARRY LYTLE, Plaintiff,


JEFFREY L. VIKEN, Chief District Judge.


Plaintiff Dr. Larry Lytle filed a verified petition seeking a declaratory judgment determining that the defendants, both as agencies of the United States government and agency employees, violated Dr. Lytle's and others' constitutional rights.[1] (Docket 1 at p. 6). Plaintiff also claims the individually named defendants committed acts in bad faith, with unclean hands, and committed a fraud on the court in applying for administrative inspection warrants. Id . Finally, plaintiff alleges neither the Food and Drug Administration (FDA) nor the district court have any jurisdiction or authority over private membership associations (PMAs). Id. at p. 7. Defendants filed a motion to dismiss plaintiff's petition for declaratory relief. (Docket 8). For the reasons stated below, plaintiff's petition is dismissed without prejudice.


Plaintiff Dr. Larry Lytle, DDS, is a retired dentist living in Rapid City, South Dakota. (Docket 27 at p. 1). Dr. Lytle and his business associations, Business Wizards, Inc., a/k/a QLaser Solutions Private Membership Association, and 2035, Inc., are involved in the manufacture and distribution of low-level laser devices called "QLasers." 13-MC-42 (Docket 2 at p. 2 ¶ 2). "Two QLaser models, the Q1000 and the 660 FlashProbe, received FDA clearance... on January 30, 2009, for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional." Id. at p. 3 ¶ 5. The FDA's inspections over a number of years revealed QLasers are distributed throughout the United States. Id. at p. 2 ¶ 3.

On its website, Business Wizards, Inc., markets QLasers to reduce pain associated with high blood pressure, broken bones, varicose veins, diabetes, and other diseases and conditions. Id . This website is also used to solicit membership in a private membership association, through which members can "receive valuable information about how QLaser can assist... in restoring electrons at the atomic level of the cells, control pain, reduce aging, control blood sugar, improve memory and learning and in general help... maintain... health...." Id. at pp. 2-3 ¶ 4.

The FDA attempted to inspect Dr. Lytle's facilities in December 2012. Id. at p. 4 ¶ 8. Dr. Lytle refused to provide the FDA investigators with access to the facilities or documents required to be maintained under federal law. Id . Dr. Lytle's son, Kip Lytle (Mr. Lytle), advised the FDA investigators he was a "Trustee" of the QLaser Solutions Private Membership Association, which had been in operation for about one and one-half years. Id. at pp. 4-5 ¶ 9. Mr. Lytle explained he distributes QLasers to PMA members across the country and provides those members with education and assistance in meeting their health needs. Id. at p. 5 ¶ 9. When asked by the investigators to produce detailed information about the devices, an adverse event log, and documentation of the PMA agreement, Mr. Lytle refused to do so. Id. at pp. 5-6 at ¶¶ 12 & 13. Mr. Lytle declared the FDA had no "Constitutional right" to be at his establishment. Id. at p. 6 ¶ 14.

The FDA investigator's affidavit included the following declaration: "These [activities and] statements render QLasers devices under the [Food, Drug and Comestics] Act because they demonstrate that QLasers are intended for use... in the cure, mitigation, treatment, or prevention of disease, ' and are intended to affect the structure or any function' of the human body." Id. at p. 3 ¶ 4 (referencing 21 U.S.C. § 321(h)).

On September, 10, 2013, Magistrate Judge Veronica L. Duffy signed warrants for administrative inspections of 2035, Inc., and Business Wizards, Inc., a/k/a/ QLaser Solutions Private Membership Association. See 13-MC-41 (Docket 4); 13-MC-42 (Docket 6); see also Docket 1 at p. 3. The warrants issued by the magistrate judge specifically outlined the FDA's inspection authority.

Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act"), 21 U.S.C. § 374, you are authorized to enter the above-described premises at reasonable times during ordinary business hours to access, copy, and verify the records to which FDA is entitled under the Act for all of the firm's devices. Such records include, but are not limited to: (1) Design Controls, Purchasing Controls, Corrective and Preventive Action Records, Device Labeling, Distribution Records, Device Master Records, Device History Records, Complaint Files, and Servicing Records, as described in 21 C.F.R. §§ 820.30, 820.50, 820.100, 820.120, 820.160, 820.181, 820.184, 820.198, and 820.200; and (2) Additional Listing Information, as described in 21 C.F.R. § 807.26.
The inspection authorized by this administrative warrant will begin as soon as practicable after the issuance of this warrant and will be completed with reasonable promptness. A written notice of inspection and the credentials of the FDA Investigator(s) will be presented as prescribed by 21 U.S.C. § 374(a)(1).

See 13-MC-41 (Docket 4); 13-MC-42 (Docket 6); see also Docket 1 at p. 3.

Assisted by Deputy United States Marshals, FDA investigators executed the administrative inspection warrants on September 10 through September 12, 2013. 13-MC-41 (Docket 7-1); 13-MC-42 (Docket 7-1). The FDA collected numerous records including purchase orders, invoices, receipts, a distributor list, promotional material, and labeling. Id . Dr. Lytle filed this action three months later on December 10, 2013. (Docket 1).



In his verified petition, Dr. Lytle asserts FDA personnel "violated numerous rights of [Dr. Lytle] and others[3] that are secured to [Dr. Lytle] and others by the Constitution of the State of South Dakota and The Constitution for the United States of America, ... as amended and ratified by The Bill of Rights, ...; that FDA personnel acted in bad faith, with unclean hands, and committed a fraud upon the Court in the affidavits supporting the applications for the warrants by implying that this Court... controls the activities of 2035 PMA, QLaser Solutions PMA, QLasers PMA [and] Energy for Life PMA... when, in fact, the Court does not." Id. at p. 6 (bold omitted). Plaintiff asserts "[t]he purpose of creating 2035 PMA and QLaser Solutions PMA by a contract was to specifically create a non-statutory private membership association which would not be generally subject to public laws and regulations including, but not limited to, public business entity laws of the State of South Dakota, of any other State of [t]he United States of America, or of the United States." Id. at p. 7. Plaintiff alleges the named "FDA personnel knew, or should have known, that [private membership associations] created by [Dr. Lytle]... were not generally subject to the jurisdiction of the Public Law creating the FDA, enforcement [r]egulations or internal [r]ules." Id . Dr. Lytle alleges "[n]either the FDA nor this Court has absolute or, generally, even limited jurisdiction over internal functions of private contracts or of internal activity of private membership associations created by a contract authored by people acting in their real or private character and capacity, as a man or woman." Id. at p. 7 (bold omitted).

In his prayer for relief Dr. Lytle seeks the following remedies:

1. Enter[ ] a Declaratory Judgment... declaring that 2035 PMA, QLasers Solutions PMA, QLasers PMA, Energy for Life PMA, and any other PMA created by Petitioner are hereby recognized by the United States as private membership associations created by people pursuant to a contract; and, that pursuant to the PMA contracts, the private membership associations are not generally subject to the jurisdiction of the Public Law creating the FDA; that the FDA generally has no authority to attempt to submit the above referenced PMAs to the Regulations implementing or explaining the laws the FDA enforces; or to the FDA's internal Rules unless the FDA brings to this Court, or to any other court of competent jurisdiction and proper venue, conclusive documentary evidence or competent sworn testimony proving that any PMA created by Petitioner has, by statements uttered or published, acts committed, or omissions made created a "real and identifiable substantive evil" that the Court must address; and,
2. Sanction[ ] all FDA personnel who signed the affidavits supporting the applications for the warrants the Court issued and all FDA personnel who served and executed the warrants; and,
3. Enter[ ] an Order requiring that the FDA forthwith returns all brochures, books, invoices, serial numbers of products, the personal notes of all investigators involved in the searches complained of herein, any and all other information relevant to the searches and any and all copies thereof relevant to 2035 PMA, QLaser Solutions PMA, QLasers PMA, Laser Wellness PMA, Energy for Life PMA and any other PMA that the FDA received documents concerning or information on and removed same from Petitioner's offices; and,
4. For any and all further relief that the Court finds ...

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