MARC T. TREADWELL, District Judge.
In this case, the Government contends the Defendants are violating several federal laws and regulations by marketing and selling various products as treatments or cures for cancer and other ailments. The Government seeks a permanent injunction to halt the Defendants' activities and has moved for summary judgment. (Doc. 17). For the following reasons, the motion is
Defendant BioAnue is a Georgia corporation whose facility is located in Rochelle, Georgia. BioAnue manufactures a variety of products it describes as dietary supplements, including TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, and Bovine Cartilage. (Doc. 17-4, ¶ 4; Doc. 19-3, ¶¶ 1-3). Defendant Gloria Raber is BioAnue's chief executive officer and is responsible for all of its operations, including writing and approving product claims. (Doc. 17-4, ¶ 5; Doc. 19-3, ¶ 10). Defendant Kelly Raber is Gloria Raber's husband. He is responsible for formulating BioAnue's products. (Doc. 8, ¶ 20; Doc. 17-4, ¶ 6; Doc. 17-6, ¶ 13; Doc. 19-3, ¶¶ 12-13). Gloria and Kelly Raber are the trustees of Free Speech Trust,
BioAnue receives its product components from out-of-state sources and sells its products to out-of-state customers.
(Doc. 17-11, ¶ 6; see also http://www.tumorx.org/cardio-clean.html, accessed July 14, 2014). Or in the case of Apoptosis Full Strength, which is also known as bloodroot, the website www.cancerx.org offered the following discussion:
(Doc. 17-11, ¶ 9; see also http://www.cancerx.org/full-strength.html, accessed July 14, 2014).
The websites also feature endorsements from purported consumers of BioAnue products. For instance, in promoting Stroke Mender capsules, the website www.cancerx.org offers the claims of 42-year-old Harriett from California, who said she had suffered a stroke at age 29:
(Doc. 25-2 at 2) (emphasis in original). On the website www.hopewelltechnologieslimited.com, photos and testimonials recount the success numerous people found using TumorX Paste
(Doc. 25-1 at 3-4) (emphasis in original).
Some of these sites feature "video lectures" by Kelly Raber about BioAnue products. (Doc. 25). In one such lecture on www.cancerx.org, while Kelly Raber boasts about the benefits of Cardiovascular Mender, the address for the website www.bioanue.com is displayed across the bottom of the screen. (Doc. 25). In the video, Kelly Raber frequently uses the pronouns "we" and "our" when referring to the producers of Cardiovascular Mender, which he promises will heal many serious medical conditions. He claims that BioAnue's products cure incurable diseases:
(Doc. 25, Ct. Ex. 3 at 17:05-17:54) (DVD on file with the clerk of court).
Embedded among all of this information about BioAnue products are hyperlinks that route potential buyers through www.bioanuelabs.com and then lead to an online shopping cart on www.vmhe.com, the website that processes the actual purchase.
On February 9, 2012, the United States Food and Drug Administration ("FDA") issued a warning letter to Gloria Raber and BioAnue informing them the claims made on the websites discussed above established that BioAnue's products were "drugs" under 21 U.S.C. § 321(g)(1)(B) and that they could not be legally marketed in the United States without prior FDA approval. (Doc. 17-4 at 12). In March 2012, Gloria Raber responded through a letter from her lawyer that the only websites she or BioAnue owned were www.bioanuelabs.com and www.vmhe.com, and that statements made on other sites were "quite outside our direct control." (Doc. 17-4 at 18). This became one of the Defendants' primary arguments for avoiding federal regulations: Neither BioAnue nor Gloria Raber profess to control statements about BioAnue products made on the websites Kelly Raber operated, so they say these statements cannot be connected to BioAnue products for purposes of determining the products' intended use.
Five months later, between August 14 and August 24, 2012, the FDA followed up on its warning letter by conducting a multi-day inspection of the BioAnue facility. (Doc. 17-4, ¶ 10). The inspection revealed several violations of the FDA's current good manufacturing practice regulations, which are promulgated at 21 C.F.R. Part 111. (Doc. 17-4, ¶ 13). Investigators discovered, for example, that BioAnue failed to test its raw material ingredients or finished products; failed to qualify its raw material ingredient suppliers; failed to establish specifications for its raw material ingredients or finished products; or failed to establish quality control operations to review batch records for approving or rejecting batches for release. (Doc. 17-4, ¶ 14; Doc. 17-4 at 52; Doc. 17-15, ¶¶ 7-21). Investigators met with Gloria Raber at the end of the inspection, discussing with her the significance of the violations observed and explaining that the FDA may pursue regulatory action. (Doc. 17-4, ¶ 16). Following the inspection, the Defendants contend they made corrections to the deficiencies in their manufacturing process and purchased new equipment to come into compliance with federal regulations. (Doc. 19-1, ¶¶ 3-4).
Despite whatever corrective actions the Defendants may have taken, in May 2013, the Government filed suit against the Defendants to enforce various provisions of the Federal Food, Drug, and Cosmetic Act ("the Act"), 21 U.S.C. § 301 et seq. (Doc. 1). The Government seeks a permanent injunction to stop the Defendants from selling their products in violation of the Act and has moved for summary judgment.
Summary judgment must be granted "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). "A factual dispute is genuine only if `a reasonable jury could return a verdict for the nonmoving party.'" Info. Sys. & Networks Corp. v. City of Atlanta, 281 F.3d 1220, 1224 (11th Cir. 2002) (quoting United States v. Four Parcels of Real Prop., 941 F.2d 1428, 1437 (11th Cir. 1991)). The burden rests with the moving party to prove that no genuine issue of material fact exists. Info. Sys. & Networks Corp, 281 F.3d at 1224. The party may support its assertion that a fact is undisputed by "citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials." Fed. R. Civ. P. 56(c)(1)(A).
"`If the moving party bears the burden of proof at trial, the moving party must establish all essential elements of the claim or defense in order to obtain summary judgment.'" Anthony v. Anthony, 642 F.Supp.2d 1366, 1371 (S.D. Fla. 2009) (quoting Four Parcels of Real Prop., 941 F.2d at 1438). The moving party must carry its burden by presenting "credible evidence" affirmatively showing that, "on all the essential elements of its case, on which it bears the burden of proof at trial, no reasonable jury could find for the non-moving party." Four Parcels of Real Prop., 941 F.2d at 1438. In other words, the moving party's evidence must be so credible, that if not controverted at trial, the party would be entitled to a directed verdict. Id.
"If the moving party makes such an affirmative showing, it is entitled to summary judgment unless the nonmoving party, in response, `comes[s] forward with significant, probative evidence demonstrating the existence of a triable issue of fact.'" Id. at 1438 (quoting Chanel, Inc. v. Italian Activewear of Fla., Inc., 931 F.2d 1472, 1477 (11th Cir. 1991)) (alteration in original). However, "credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge. . . . The evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). Thus, the Court "`can only grant summary judgment if everything in the record demonstrates that no genuine issue of material fact exists.'" Strickland v. Norfolk S. Ry. Co., 692 F.3d 1151, 1154 (11th Cir. 2012) (quoting Tippens v. Celotex. Corp., 805 F.2d 940, 952 (11th Cir. 1992)).
The Act gives courts the authority to enjoin conduct that violates its provisions. 21 U.S.C. § 332(a). The standard for granting an injunction under the Act is controlled by the Act itself, so the traditional multi-factor analysis associated with requests for injunctive relief does not apply. See Klay v. United Healthgroup, Inc., 376 F.3d 1092, 1098 (11th Cir. 2004); United States v. Ocala Live Stock Market, Inc., 861 F.Supp.2d 1328, 1335-36 (M.D. Fla. 2012); United States v. James, 2004 WL 838078, at *1 (M.D. Ga.). Instead, the Act grants the Court jurisdiction to issue an injunction simply "for cause shown." 21 § U.S.C. 332(a). The Government must demonstrate the Defendants violated the Act and that there is a likelihood of future violations. See United States v. W.T. Grant Co., 345 U.S. 629, 633 (1953); United States v. Mercantile Corp., 889 F.Supp.2d 1058, 1084 (W.D. Tenn. 2012). Consequently, in actions for statutory injunction such as this one, "the agency need not prove irreparable injury or the inadequacy of other remedies as required in private injunctive suits. A prima facie case of illegality is sufficient." Commodity Futures Trading Comm'n v. Muller, 570 F.2d 1296, 1300 (5th Cir. 1978).
The Government first contends the Defendants violated 21 U.S.C. § 331(d) by selling unapproved new drugs in interstate commerce. Under the Act, "drug" means, among other things, "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man." 21 U.S.C. § 321(g)(1). In determining whether an article is a "drug" under this statutory definition, "[t]he vendor's intent is the key element." United States v. Articles of Drug for Veterinary Use, 50 F.3d 497, 500 (8th Cir. 1995) (quoting United States v. Storage Spaces Designated Nos. 8 & 49, 777 F.2d 1363, 1366 (9th Cir. 1985)); see also Nat'l Nutritional Foods Ass'n v. Mathews, 557 F.2d 325, 333 (2d Cir. 1977).
"The FDA is not bound by the manufacturer's subjective claims of intent but can find actual therapeutic intent on the basis of objective evidence." Nat'l Nutritional Foods Ass'n, 557 F.2d at 334. Any relevant source, such as product labels or promotional material, may provide the vendor's intended application for a product. Articles of Drug for Veterinary Use, 50 F.3d at 500. Labeling includes "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." Id.; 21 U.S.C. § 321(m). The promotional materials need not be physically attached to the product. Id.; Kordel v. United States, 335 U.S. 345, 349 (1948); see also United States v. Sarcona, 457 F. App'x 806, 813-14 (11th Cir. 2012).
FDA regulations further discuss determination of intent:
21 C.F.R. § 201.128; see also United States v. Regenerative Sciences, LLC, 741 F.3d 1314, 1319 (D.C. Cir. 2014). Consequently, under this intent analysis, a substance promoted as a treatment or cure for cancer, AIDS, or other diseases is a "drug" under the Act, even if it could be classified as something else, such as a "homeopathic" remedy. See, e.g., United States v. Writers & Research, Inc., 113 F.3d 8, 11 (2d Cir. 1997).
In this case, there is substantial objective evidence that the BioAnue products are "drugs" based on labeling on the various websites from which the products are peddled. The websites run by Kelly Raber are replete with claims that BioAnue's products are intended to cure, mitigate, treat, or prevent disease in man. This intent is objectively apparent from statements such as Cardio Clean's claim to "transform[ ] artery clogging cholesterol into disease fighting substances needed for proper function inside the body" and Apoptosis Full Strength's assertion that it can be used for cancer, herpes, migraines, and more. (Doc. 17-11, ¶¶ 6, 9). Just as probative of the Defendants' intent, if not more so, are the testimonials from people who allegedly used BioAnue products and healed themselves of cancer or paralysis. Kelly Raber himself preaches the ability of Heart Mender and Cardiovascular Mender to cure COPD. And similar claims about BioAnue's other products permeate the Defendants' websites. (Doc. 17-11, ¶¶ 5-20; Doc. 25-1; Doc. 25-2). The overarching message of all of this clearly establishes these products are intended to cure, mitigate, treat, or prevent disease.
The Defendants do not dispute these facts or the content of these statements. Rather, they try to avoid classifying their products as drugs by disclaiming any link between what is said on Kelly Raber's websites and the products on the BioAnue and Gloria Raber websites through which purchases are actually made. During the hearing on the Government's motion for summary judgment, counsel contended Kelly Raber is merely a writer who enjoys expressing his thoughts about BioAnue products, expanding on Gloria Raber's assertion that these websites are outside of her or BioAnue's control.
This argument is frivolous. The Defendants admit that Kelly Raber is responsible for formulating BioAnue's products. (Doc. 8, ¶ 20; Doc. 19-3, ¶ 13). His name is on the address from which BioAnue products ship, he is a trustee and co-owner with Gloria Raber of the trust that owns the trademarks under which BioAnue products are sold, he communicates with customers on behalf of BioAnue, and he has recorded lengthy video lectures about the benefits of BioAnue products while BioAnue's website address is plastered across the screen. Kelly Raber is clearly acting in concert with BioAnue and Gloria Raber, and therefore the statements made on the websites he operates are clearly relevant as labeling in connection with BioAnue products.
Thus, there is undisputed evidence that the BioAnue products are "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man." 21 U.S.C. § 321(g)(1). The Defendants have not come forward with any evidence demonstrating the existence of a triable issue that BioAnue products are sold with some other intent. Nor have they presented any evidence to create a genuine dispute about the relationship between Kelly Raber and BioAnue or Gloria Raber. Their burden on these issues in response to the Government's summary judgment motion simply has not been met. BioAnue's products are "drugs."
Not only are BioAnue's products "drugs," they are "new drugs" because they are drugs that are "not generally recognized . . . as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof." 21 U.S.C. § 321(p)(1). Generally, new drugs must be approved by application to the FDA.
Under the statute, "substantial evidence" means "evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts . . . [that] satisfy a host of technical scientific requirements, including a valid comparison with a control such as an active treatment trial that includes randomization and blinding of patients or investigators." 50 Boxes More or Less, 909 F.2d at 26 (internal quotation marks omitted); 21 U.S.C. § 355(d). Additionally, studies that claim a drug is generally recognized as safe and effective must be published in scientific literature available to qualified experts, and there needs to be a consensus of opinion by those experts that the drug is safe and effective for its labeled uses.
In March 2014, the Government's witness, Corey J. Hilmas, M.D./Ph.D., performed a "comprehensive search of the available literature" and found no published studies of any kind on the Defendants' products. (Doc. 17-11, ¶¶ 25-26). Hilmas also searched FDA records and found no approved new drug applications for any of the Defendants' products. (Doc. 17-11, ¶¶ 29-30). Nor did the products conform to any over-the-counter monograph that would exempt them from premarket approval requirements. (Doc. 17-11, ¶ 31).
The Defendants have not contested these facts. Instead, they object to Dr. Hilmas's testimony on grounds that he is acting as an expert witness even though the Government disclosed no expert witnesses. However, it is clear in this context that Dr. Hilmas is not providing expert opinion. Rather, he is simply reciting the process and results of his search of the available literature and FDA records. His testimony that he found nothing pertaining to the Defendants' products merely describes his own personal knowledge of the actions he took, and this personal knowledge is all the Court relies on when reaching its conclusions. Again, in response to the Government's motion, the Defendants did not come forward with any evidence to create a triable issue as to whether BioAnue products are generally recognized as safe and effective or should be treated as something other than "new drugs." They have not met their burden at summary judgment.
Consequently, the undisputed facts are that the Defendants are selling new drugs that have not been approved by the FDA and that are not generally recognized as safe and effective. This violates the Act.
The Defendants insist, without evidence, that their products are not drugs but "dietary supplements." Dietary supplements are products intended to supplement the diet and may contain vitamins, minerals, herbs, amino acids, some other substance intended to increase dietary intake, or a combination of such ingredients. Dietary supplements are deemed to be a food within the meaning of the Act. See 21 U.S.C. § 321(ff).
But even if the Defendants were selling dietary supplements rather than drugs, they still have violated the law by not adhering to FDA regulations in their manufacturing process and causing their food products to become "adulterated." See 21 U.S.C. § 331(a), (k). Dietary supplements are "adulterated" when they have "been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations." 21 U.S.C. § 342(g)(1). "Current good manufacturing practice regulations" are outlined by the FDA in 21 C.F.R. Part 111. They "govern numerous aspects of the manufacturing process, including (1) the qualifications and responsibilities of personnel; (2) standards for the design and construction of buildings, facilities, and equipment; (3) laboratory controls; and (4) requirements for record keeping, packaging and labeling." John D. Copanos and Sons, Inc. v. Food and Drug Admin., 854 F.2d 510, 514 (D.C. Cir. 1988). The point of these regulations is to ensure sanitary conditions and limit other factors that might cause contamination or "render[ ] the . . . dietary supplement or drug potentially harmful." Nutritional Health Alliance v. Food and Drug Admin., 318 F.3d 92, 100 (2d Cir. 2003). Violation of the regulations means products can be declared "adulterated" as a matter of law; the Government does not need to prove the substance was actually adulterated. Id. at 100 & n.9; Copanos and Sons, 854 F.2d at 514.
The August 2012 inspection of Defendants' facilities found a range of violations of the FDA's current good manufacturing practice regulations. These violations included:
(Doc. 17-4 at 52-55; Doc. 17-15, ¶¶ 6-22). Because the Defendants were not in compliance with the FDA's current good manufacturing practice regulations, their products, as dietary supplements, are considered "adulterated" as a matter of law.
The Defendants do not contest the fact they were not adhering to the FDA's current good manufacturing practice regulations. Rather, they contend that since the inspection, they have made investments and modifications to conform to these regulations.
For the Defendants to avoid an injunction, they must "demonstrate that there is no reasonable expectation that the wrong will be repeated." W.T. Grant Co., 345 U.S. at 633. This is a heavy burden that may not be overcome by the Defendants simply telling the Court they are no longer violating the current good manufacturing practice regulations and do not intend to violate the regulations in the future. Id. Meanwhile, the Government can satisfy the Court that an injunction is necessary by showing "there exists some cognizable danger of recurrent violation, something more than the mere possibility which serves to keep the case alive." Id. The Eleventh Circuit has found relevant at least three factors in making these determinations: "(1) whether the challenged conduct was isolated or unintentional, as opposed to a continuing and deliberate practice; (2) whether the defendant's cessation of the offending conduct was motivated by a genuine change of heart or timed to anticipate suit; and (3) whether, in ceasing the conduct, the defendant has acknowledged liability." Sheely v. MRI Radiology Network, P.A., 505 F.3d 1173, 1184 (11th Cir. 2007).
Here, the challenged conduct was not isolated or unintentional. Prior to the inspection that revealed their violations, the Defendants were, for an ongoing period, deliberately engaged in the manufacture and production of drugs or dietary supplements without regard for the FDA's regulatory requirements. The change in process that purportedly brings BioAnue in compliance with the law came not on the Defendants' own initiation but instead was clearly motivated by a desire to avoid liability following FDA investigators' findings of wrongdoing and in advance of a lawsuit like this one. Simply telling the Court they are no longer violating the current good manufacturing practice regulations and do not intend to violate them again is insufficient to stave off injunctive relief that will prevent future violations.
Accordingly, the undisputed facts demonstrate the Defendants failed to comply with FDA manufacturing regulations, thereby introducing adulterated dietary supplements into interstate commerce in violation of 21 U.S.C. § 331(a), (k). The Defendants' professed changes to their manufacturing process are not enough to suggest there is no reasonable expectation they will repeat their violations.
The Government has provided evidence of the Defendants' prima facie violations of the Act — most notably their selling of unapproved, misbranded drugs in interstate commerce and, additionally, even if they are selling dietary supplements, their failure to follow the FDA's current good manufacturing practice regulations. The Defendants have not provided evidence sufficient to create a genuine dispute as to any material fact underlying the Government's case against them.
Consequently, the Government's motion for summary judgment is
