United States v. Genesis II Church of Health & Healing

• Citation: 476 F.Supp.3d 1283
• Decision Date: 03 August 2020
• Docket Number: Case No. 20-21601-CIV-WILLIAMS
• Court: U.S. District Court — Southern District of Florida
• Parties: UNITED STATES of America, Plaintiff, v. GENESIS II CHURCH OF HEALTH AND HEALING, et al., Defendants.

476 F.Supp.3d 1283

UNITED STATES of America, Plaintiff,

v.GENESIS II CHURCH OF HEALTH AND HEALING, et al., Defendants.

Case No. 20-21601-CIV-WILLIAMS

United States District Court, S.D. Florida.

Signed August 3, 2020

David Frank, R. Goldstein, US Department of Justice, Washington, DC, Matthew James Feeley, Department of Justice; U.S. Attorneys Office, Miami, FL, for Plaintiff.

Genesis II Church of Health and Healing, Bradenton, FL, pro se.

Jordan Grenon, Bradenton, FL, pro se.

Jonathan Grenon, Bradenton, FL, pro se.

ORDER

KATHLEEN M. WILLIAMS, UNITED STATES DISTRICT JUDGE

THIS MATTER is before the Court on Plaintiff's, United States of America ("Government"), motion for final default judgment against Mark Grenon and Joseph Grenon (collectively, "Defendants"). (DE 72.) Defendants have not responded to the motion and the time to do has now passed.

For the reasons below, the motion (DE 72) is GRANTED .

I. BACKGROUND

This action arises out of Defendants’ marketing and distribution of a product called Miracle Mineral Solutions ("MMS"), a drug Defendants claim is a cure for COVID-19 and other serious diseases. MMS consists of 22.4% sodium chlorite (NaClO2), 5% sodium chloride

(NaCl), 1% "trace minerals," and 71.6% purified water. (DE 3 at 5.) It is sold with an "activator" that contains 4% hydrochloric acid (HCI). (Id. ) When the MMS and the activator are combined, as directed by the product labeling, a chemical reaction occurs yielding chlorine dioxide (ClO2), a chemical commonly used as an industrial bleach. (Id. )

Mark Grenon is the founder of Genesis II Church of Health and Healing ("Genesis"), an entity based in Bradenton, Florida that describes itself as a "non-religious church," focused on "restoring health to the world." (DE 1 ("Complaint") at ¶¶ 4, 5.) While the organization is non-religious, its leaders hold clerical titles. Mark Grenon holds the title "Archbishop" and Joseph Grenon is known as a "Bishop." (Id. at ¶¶ 5-6.) Defendants, along with its other leaders, are involved in Genesis’ operations, including the labeling, holding, and distribution of MMS. (Id. at ¶¶ 5-6.)

Defendants operated several websites on which they marketed and sold MMS, including www.newg2sacraments.org ("Sales Website"), g2churchnews.org ("News Website"), g2voice.is ("Radio Website"), genesis2church.ch, and others.¹ (Id. at ¶ 4.) On these websites, Defendants explained that MMS is a treatment and cure for COVID-19, Alzheimer's, autism

, brain cancer, HIV/AIDS, multiple sclerosis, and other illnesses. (Id. ) For instance, on March 3, 2020, Defendants posted the following claims on the News Website:

G2Church Sacramental Dosing for Coronavirus!

For Adults : 6 drops activated MMS in 4 ounces of water every two hours 5 times first day, Repeat 2nd day. If all symptoms are gone then continue with 3 drops and [sic] hour for 8 hours for another 3 days!

For Small Children : same a [sic] above but with only 3 drops. 1 drop instead of 3 drops of the 3 days after the first two days of strong dosing!

NOTE: This should wipe it out this flu-like virus that many are being scared with its presence in this world!

For Sacramental Guidance and products please contact us at: support@genesis2church.is

The Coronavirus is curable!

(Complaint at ¶ 14.) Defendants also distributed MMS in interstate commerce to customers who made purchases on the Sales Website. (DE 3 at 8.) On March 27, 2020, an undercover Food Drug Administration ("FDA") employee visited the Sales Website and ordered various MMS products. (DE 3-1 at ¶ 16.) On March 30, 2020, the FDA received Defendants’ package containing the purchased products in Ashburg, Virginia, with a return address in Bradenton, Florida. (DE 3-2 at ¶ 11.)

On April 8, 2020, the FDA issued a warning letter to Defendants informing them that their marketing and distribution of MMS violated the FDCA. (DE 3-2 at ex. 8.) The letter requested Defendants to respond within 48 hours by describing the steps they have taken to correct the violations and warned them that their failure to comply may result in legal action. (Id. ) A day later, Defendants posted the letter on the News Website, and in a response attributed to Mark Grenon, they stated that the FDA did not have jurisdiction over their activities or products, and that they would not be taking any corrective action. (Id. at ex. 9.) The post included a call to action to the organization's members, imploring them to send emails to the FDA, FTC, and the President. (Id. ) Shortly after this response was posted, the FDA also received a written response signed by Mark Grenon, that stated the following:

We are NOT under your authority in regard to your agencies

We DO NOT need your approval for [MMS] or for anything we do in our Church.

You have NO authority over us so why would we even consider your Act?

We can say cure, heal, and treat as a Free Church. Don't need you [sic] approval or authorization ....

There will be NO corrective actions on our part ... You have no authority over us!

We will NOT stop our Church Sacraments! ... we will NOT comply!"

We don't have to cease anything in regard to our Church Sacraments [MMS]! You cease and desist and harassing us!

(Id. at ex. 10.) Because Defendants did not comply with the warning letter, on April 16, 2020, the Government filed a Complaint against them seeking a permanent injunction under 21 U.S.C. § 332(a) to enjoin them from violating the following sections of the FDCA: 21 U.S.C. § 331(d) for introducing into interstate commerce unapproved new drugs; 21 U.S.C. § 331(a) for introducing into interstate commerce drugs that are misbranded within the meaning of 21 U.S.C. §§ 352(f)(1) and (a) ; and 21 U.S.C. § 331(k) for causing drugs to become misbranded while they are held for sale after shipment of one or more of their components in interstate commerce.² (Complaint at ¶¶ 9-13.)

On June 15, 2020, the summons and Complaint were properly served on Mark Grenon and Joseph Grenon pursuant to the Court's Order granting the United States’ motion for alternative service. (DE 48; DE 50-1.) Pursuant to Rule 12(a)(4)(A) of the Federal Rules of Civil Procedure, the applicable time for Mark Grenon and Joseph Grenon to respond to the Complaint expired on July 6, 2020. Because Defendants did not respond to the Complaint, on May 29, 2020, the Government obtained a clerk's entry of default against them. (DE 61.) The Government now moves for the final entry of default judgment.³ (DE 72.)

II. LEGAL STANDARD

Under Rule 55 of the Federal Rules of Civil Procedure, if a defendant fails to plead or otherwise defend against a complaint, the Clerk of the Court may enter a default against that defendant. Fed. R. Civ. P. 55(a). Where a default occurs, the plaintiff's well-pled allegations are deemed admitted. Buchanan v. Bowman , 820 F.2d 359, 361 (11th Cir. 1987). Once a default is entered, a plaintiff may seek entry of a default judgment against the defaulting defendant. Fed. R. Civ. P. 55(b). A default judgment, however, is a matter of discretion for the court, not a matter of right to the moving party. See Pitts ex rel. Pitts v. Seneca Sports, Inc. , 321 F.Supp.2d 1353, 1356 (S.D. Ga. 2004). Before entering a default judgment, the court must ensure that the well-pled allegations in the complaint, taken as true by virtue of the default, actually state a substantive cause of action, and that there is a substantive, sufficient basis in the pleadings for the particular relief sought. Tyco Fire & Sec., LLC v. Alcocer , 218 F. App'x 860, 863 (11th Cir. 2007). While a defaulted defendant cannot challenge the sufficiency of the evidence, "[it] is entitled to contest the sufficiency of the complaint and its allegations to support the judgment." Cotton v. Mass. Mut. Life Ins. Co. , 402 F.3d 1267, 1278 (11th Cir. 2005).

"Entry of default judgment is only warranted when there is ‘a sufficient basis in the pleadings for the judgment entered.’ " Surtain v. Hamlin Terrace Found. , 789 F.3d 1239, 1245 (11th Cir. 2015) (citation omitted). The Eleventh Circuit has explained that the standard for assessing entitlement to default judgment is "akin to that necessary to survive a motion to dismiss for failure to state a claim." Id. (citing Chudasama v. Mazda Corp. , 123 F.3d 1353, 1370 n.41 (11th Cir. 1997) ).

III. DISCUSSION

In its motion, the Government seeks final default judgment against Defendants as to the three FDCA claims asserted in its Complaint: 21 U.S.C. § 331(d), distribution of unapproved new drugs into interstate commerce; 21 U.S.C. § 331(a), introduction of a misbranded drug into interstate commerce; and 21 U.S.C. § 331(k), causing the misbranding of drug while held for sale after shipment of its components in interstate commerce. The Government also urges the Court to enter a permanent injunction under 21 U.S.C. § 332 (a) to restrain Defendants from continued violations of these provisions. The Court first considers Plaintiff's entitlement to default judgment and then its request for a permanent injunction.

A. The Government's Entitlement to Final Default Judgment

1. 21 U.S.C. § 331(d)

The FDCA defines a "drug" as a substance that is "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man." 21 U.S.C. § 321(g)(1)(B). "The intended use of a product may be determined from any relevant source, including labeling." 21 C.F.R. § 201.128. "Labeling" is defined as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." 21 U.S.C. § 321(m). The labeling need not be physically attached to the product and includes anything that explains the uses of the drug, such as marketing materials and websites. See Kordel v. United States , 335 U.S. 345, 69 S.Ct. 106, 93 L.Ed. 52 (1948) ; United States v. Flu Fighter Corp , 2009 WL 10668958, at *4 n.2 (S.D. Fla. Feb. 11, 2009) (finding the products’ websites to constitute "labeling" under the FDCA); United States v....