United States v. Genesis II Church of Health & Healing

Decision Date09 July 2020
Docket NumberCase No. 20-21601-CIV-WILLIAMS
Citation472 F.Supp.3d 1270
Parties UNITED STATES of America, Plaintiff, v. GENESIS II CHURCH OF HEALTH AND HEALING, et al., Defendants.
CourtU.S. District Court — Southern District of Florida

David Frank, R. Goldstein, U.S. 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 Genesis II Church of Health and Healing, Jonathan Grenon, and Jordan Grenon (collectively, "Defendants"). (DE 49.) Defendants have not responded to the motion and the time to do has now passed. For the reasons below, Plaintiff's motion (DE 49) is GRANTED .

I. BACKGROUND

This action arises out of Defendants’ violation of the Food, Drug, and Cosmetic Act ("FDCA") by marketing and distributing a product called Miracle Mineral Solutions ("MMS"), a drug Defendants claim is a cure for COVID-19 and other serious diseases. MMS is comprised 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. )

Genesis II Church of Health and Healing ("Genesis") is a secular entity based in Bradenton, Florida that describes itself as a "non-religious church," that is focused on "restoring health to the world." (DE 1 ("Complaint") at ¶ 4.) While the organization is non-religious, its leaders hold clerical titles. Defendants Jonathan Grenon and Jordan Grenon are known as "Bishops," and are responsible for Genesis’ operations, including the labeling, holding, and distribution of MMS. (Id. at ¶¶ 7-8.)

Defendants operate several websites on which they market and sell MMS, including www.newg2sacraments.org ("Sales Website"), g2churchnews.org ("News Website"), g2voice.is ("Radio Website"), genesis2church.ch, mmstestimonials.co, and others. (Id. at ¶ 4.) On these websites, Defendants explain—and link to testimonials that claim—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 their 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 distribute MMS in interstate commerce to customers who have made purchases on the Sales Website.1 (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 the failure to comply may result in legal action. (Id. ) A day later, Defendants posted the letter on its News Website, stating 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 also included a call to action to the organization's members, imploring them to send emails to the FDA, FTC, and the President. (Id. ) The FDA also received a written response from Defendants that included the following statements:

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. (Complaint at ¶¶ 9-13.)

Genesis and Jonathan Grenon were served with the Complaint on April 27, 2020 and Jordan Grenon was served on April 29, 2020. (DE 19-10, 19-11, 19-14.) Pursuant to Rule 12(a)(4)(A) of the Federal Rules of Civil Procedure, the applicable time for Genesis and Jonathan Grenon to respond to the Complaint expired on May 19, 2020, and on May 20, 2020 for Jordan Grenon. None of the Defendants have responded to the Complaint. Accordingly, on May 29, 2020, the Government obtained a clerk's entry of default against them. (DE 46.) The Government now moves for the final entry of default judgment. (DE 49.)

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-pleaded 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-pleaded 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 on 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 the FDCA. The Court first considers Plaintiff's entitlement to default judgment and then its request for a permanent injunction.

A. Plaintiff's Entitlement to 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, 350, 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. Innovative Biodefense, Inc. , 2019 WL...

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