Full opinion text
ORDER GARCIA, District Judge. Pending before the Court are the Motions for Partial Summary Judgment filed by Healthpoint, Ltd. (Dkt.# 187, 188); the Report and Recommendation of the United States Magistrate Judge (Dkt.# 204) and Ethex Corporation’s objections thereto (Dkt.# 217). Where no party has objected to the Magistrate Judge’s Memorandum and Recommendation, the Court need not conduct a de novo review. In such cases, the Court need only review the Memorandum and Recommendation and determine whether it is either clearly erroneous or contrary to law. United States v. Wilson, 864 F.2d 1219, 1221 (5th Cir.1989), cert. denied, 492 U.S. 918, 109 S.Ct. 3243, 106 L.Ed.2d 590 (1989). On the other hand, if any party objects to the Memorandum and Recommendation, the Court must review those portions of the report de novo. See 28 U.S.C. § 686(b)(1) (a judge of the court shall make a de novo determination of those portions of the report or specified proposed findings and recommendations to which objection is made); see also Kreimerman v. Casa Veerkamp, S.A. de C.V., 22 F.3d 684, 646 (5th Cir.1994), cert. denied, 513 U.S. 1016, 115 S.Ct. 577, 130 L.Ed.2d 492 (1994). Such a review means that the Court will examine the entire record and make an independent assessment of the law. The Court need not, however, conduct a de novo review when the objections are frivolous, conclusive, or general in nature. Battle v. United States Parole Comm’n, 834 F.2d 419, 421 (5th Cir.1987). In its objections, Ethex Corporation correctly notes some inconsistent statements in the Magistrate Judge’s report. She recommends, without objection, that Healthpoint’s Motion for Partial Summary Judgment on its claim of “palming off’ should be denied (Dkt. #204 @ p. 14). She further recommends, without objection, that Healthpoint’s Motion for Partial Summary Judgment on Ethex Corporation’s counterclaims of “misbrand-ing” and distribution of industry letters also be denied. (Dkt. #204 @ pp. 17-18). In conclusion, however, she states that Healthpoint’s Motion for Partial Summary Judgment on Ethex’s counterclaims should be “granted in part and denied in part.” (Dkt. #204 @ p. 18). This statement is contrary to the findings in the report, and it clearly appears that the recommendation is a denial of summary judgment on all claims. Because Healthpoint has not objected to the recommendation, and the Court agrees with the findings therein, the recommendation should be accepted, with the exception of the misstatement contained in the conclusion, which the Court has rejected and clarified accordingly. It is therefore ORDERED that the U.S. Magistrate Judge’s report and recommendation (Dkt.# 204) is ACCEPTED in part and REJECTED in part as set forth above, and the Motions for Partial Summary Judgment filed by Healthpoint, Ltd. (Dkt.# 187, 188) are hereby DENIED in their entirety. REPORT AND RECOMMENDATION MATHY, United States Magistrate Judge. Pursuant to the Orders of referral in the above-styled and numbered cause of action to the undersigned United States Magistrate Judge and consistent with the authority vested in United States Magistrate Judges under the provisions of 28 U.S.C. § 636(b)(1)(B) and rule 1(d) of the Local Rules for the Assignment of Duties to United States Magistrates, effective January 1, 1994, in the Western District of Texas, the following report addressing the referred motion for preliminary injunction is submitted for your review and consideration. I. JURISDICTION The Court has jurisdiction pursuant to 28 U.S.C. § 1331, 1332, 1338, and 1367. II. PROCEDURAL HISTORY By way of introduction, this lawsuit concerns two competing papain-urea wound debridement ointments, Accuzyme made by Healthpoint Ltd. (“Healthpoint”) and Ethezyme made by Ethex Corporation (“Ethex”). Both ointments are available by prescription only. Healthpoint introduced Accuzyme to the market in 1996 after reverse-engineering Panafil White, a papain-urea debridement ointment then marketed by Rystan. Thereafter, Health-point spent millions of dollars promoting Accuzyme, creating brand awareness and market acceptance. In 2000, Ethex introduced Ethezyme, a competing papain-urea wound debridement ointment, which Ethex created by reverse engineering Accuzyme. Ethex promoted Ethezyme as an “alternative” to Accuzyme. Advertising campaigns were launched for the allegiance of physicians, pharmacists, hospitals, long-term care facilities and formularies through technical advertisements in professional magazines designed to reach those consumers as well as marketing presentations by Healthpoint and letters sent by both Ethex and Healthpoint. On August 3, 2000, Healthpoint filed this suit alleging, among other claims, that Ethex copied Accuzyme, a known trademark, by adopting a name “highly similar in sight and connotation” and sound causing confusion, falsely advertised Ethezyme as an alternative for Accuzyme, and “palmed off’ Ethezyme as a Healthpoint product. On the other hand, among other counterclaims, Ethex alleges that Health-point falsely advertised the ingredients of its Accuzyme product and that Healthpoint engaged in a false and disparaging advertising campaign regarding Ethezyme. The procedural history relevant to the motions addressed in this report is relatively complicated. This lawsuit began on or about August 3, 2000, when Healthpoint filed its original complaint against Ethex. On October 11, 2000, Healthpoint filed a pre-answer first amended complaint. On February 2, 2001, Healthpoint filed a second amended complaint, its “live” pleading in this case, which brings claims under the Lanham Act, 15 U.S.C. §§ 1051 et seq. for trademark infringement in violation of § 1114(1); false advertising in violation of § 1125, unfair competition in violation of § 1125(a)(1)(A); and dilution in violation of § 1125(c); and claims under the laws of Texas for trademark infringement, false advertising, unfair competition, dilution, defamation, business disparagement, misappropriation, and palming off. Health-point requests damages, an accounting of profits, treble damages, punitive damages, attorney’s fees, costs, pre-judgment interest, and permanent and preliminary in-junctive relief on certain of its claims. On October 27, 2000, Ethex filed a counterclaim against Healthpoint and on February 2, 2001, filed an amended counterclaim adding DPT Laboratories, Ltd. (“DPT”) and DFB Pharmaceuticals, Inc. (“DFB”) as counterclaim defendants and pleading counterclaims for false advertising in violation of 15 U.S.C. § 1125(a) and for unfair competition, injurious falsehood, interference with prospective business relationships, and common law fraud in violation of Texas law. Ethex requests compensatory damages, punitive damages, attorney’s fees, costs, pre-judgment interest, an accounting of profits, treble damages and injunctive relief on various of its claims. On March 15, 2001, DPT and DFB filed their original answer to Ethex’s counterclaim which included counterclaims against Ethex and an added party, KV Pharmaceuticals, Inc. (“KV”), the parent of Ethex, alleging trademark infringement in violation of 15 U.S.C. § 1114, common law trademark infringement, false advertising in violation of 15 U.S.C. § 1125, common law false advertising, unfair competition in violation of 15 U.S.C. § 1125, common law unfair competition, trademark dilution in violation of 15 U.S.C. § 1125(c), trademark dilution under Texas law, defamation under Texas law, business disparagement under Texas law, common law misappropriation under Texas law, common law palming off under Texas law, tortious interference, civil conspiracy, misappropriation of trade secrets and confidential information, breach of contract (the protective order), breach of confidential relationship, conversion, fraud, and violation of the Texas Theft Liability Act. DPT and DFB seek actual damages, an accounting of profits, treble damages, attorney’s fees, costs expenses, pre-judgment interest and preliminary and permanent injunctive relief. Ethex filed a motion for preliminary in-junctive relief against Healthpoint on November 22, 2000. On November 30, Ethex filed its memorandum in support of its motion for preliminary injunction. On January 5, 2001, Healthpoint filed objections to Ethex’s evidence in support of its motion for preliminary injunction. On January 8, 2000, after several unopposed extensions of time, Healthpoint filed its response to the motion for preliminary injunction. On January 17, 2001, Ethex’s motion for preliminary injunction was set for a hearing on February 20, 2001. On February 2, 2001, at the joint request of the parties and after Healthpoint had tendered its cross-motion for preliminary injunction, the Court postponed the hearing on Ethex’s motion for preliminary injunction until March 22, 2001 and ordered that it be consolidated with the hearing on Healthpoint’s cross-motion. Briefing on Ethex’s motion for preliminary injunction was completed with the filing of the following documents: On February 2, 2001, Ethex filed objections to Healthpoint’s evidence in response to Ethex’s motion for preliminary injunction and its reply to its motion for preliminary injunction. On February 16, 2001, Healthpoint filed its response to Ethex’s objections to evidence. On March 5, 2001, without objection from Ethex, Healthpoint filed its sur-reply to Ethex’s motion for preliminary injunction. On February 20, 2001, Healthpoint’s motion for preliminary injunction was filed. On March 5, 2001, Ethex objected to certain of Healthpoint’s evidence in support of its motion for preliminary injunction and on March 6, 2001, Ethex filed its response to Healthpoint’s motion for preliminary injunction. On February 28, 2001, Health-point’s motion for preliminary injunction was set for a consolidated hearing with Ethex’s motion for preliminary injunction to occur on March 22, 2001. On March 14, 2001, the undersigned denied Ethex’s opposed motion to postpone the hearing on the two motions for preliminary injunction. On March 9, 2001, Ethex filed a motion to dismiss all of Healthpoint’s claims or to stay all of Healthpoint’s claims pending the completion of an on-going FDA investigation into the misbranding of Aceuzyme. On March 29, 2001, Healthpoint filed its response and counter motion to partially dismiss Ethels claims. Ethex filed its response on April 17, 2001. Beginning March 22, 2001 and ending March 29, 2001, the Court held a consolidated evidentiary hearing on Ethex’s motion for preliminary injunction and Healthpoint’s cross motion for preliminary injunction. This report and recommendation addresses those two, specially referred motions. In addition, this report also addresses Ethex’s related motion to dismiss or to stay and Healthpoint’s counter-motion to partially dismiss, since the determination of whether any of the causes of action are within the primary jurisdiction of the FDA is a matter closely related to an assessment of likelihood of success on the merits. III. ISSUES 1. Has Ethex satisfied its burden of proving entitlement to a preliminary injunction; 2. Has Healthpoint satisfied its burden of proving entitlement to a preliminary injunction; 3. Should Ethex’s motion to dismiss or for stay pending the outcome of an FDA investigation be granted and/or should Healthpoint’s counter-motion to partially dismiss Ethex’s claims be granted. IV. STANDARDS A. Preliminary Injunction Standards In this Circuit, the test for entitlement to a preliminary injunction has four parts. A preliminary injunction may be granted only if the moving party establishes each of the following four factors: (1) a substantial likelihood of success on the merits; (2) a substantial threat that failure to grant the injunction will result in irreparable injury; (3) that the threatened injury out-weighs any damage that the injunction may cause the opposing party; and (4) that the injunction will not disserve the public interest. A preliminary injunction is an extraordinary remedy and the decision to grant a preliminary injunction is to be treated as the exception rather than the rule. An evidentiary hearing is not always required before a court rules on a preliminary injunction. If factual matters are not in dispute, no oral hearing is required and the parties need only be given “ample opportunity to present their views of the legal issues involved.” On the other hand, “when factual disputes are presented, the parties must be given a fair opportunity and a meaningful hearing to present their differing versions of those facts before a preliminary injunction may be granted.” The basic question on the need for a hearing is whether it will add anything material to the Court’s consideration of the case. Evidence at a hearing on a preliminary injunction need not be “testimonial” and affidavits can be considered by the Court. The seven-day hearing concerning these two ointments, the six days of testimony, the parties’ submission of declarations or deposition excerpts in lieu of testimony, and the parties’ ability to object to or to counter-designate deposition excerpts provided the parties with sufficient opportunity to develop disputed facts relevant to the motions for preliminary injunction. As a procedural note, any reference in this report to a portion of a declaration to which a party may have objected should be considered as a decision to overrule any noted objection. Relatedly, and for the benefit of the District Court, it should be noted that the undersigned asked that if a deposition excerpt included a reference to any objection that was made at the time of the deposition and the objecting party was not willing to waive the objection for purposes of this preliminary injunction hearing only, that party was required to bring the specific non-waived objection to the attention of the undersigned. No advisory or in-court argument was made to identify any such objection. Finally, Healthpoint made and renewed an objection to Ethex’s expert opinion testimony and, particularly, to the testimony of Dr. Schondelmeyer and Dr. Ross. Healthpoint argued its objection but requested no additional hearing and did not request that any testimony be stricken after it was received. The Court has considered the objections, recognizes its gate-keeping function under Daubert and Kumho Tire, and has considered both the relevance of the evidence, including the fit to the issues in this ease, and the reliability of the evidence. The Court finds by a preponderance of the evidence that, for the purposes of the cross-motions for preliminary injunction, the expert opinion testimony constitutes specialized knowledge that will assist the trier of fact, that the evidence is sufficiently reliable and that the witnesses are qualified to provide the evidence. The Court has considered Healthpoint’s objections in assessing the weight to be given to the evidence. B. Federal Rule of Civil Procedure 12(b) Under Fed.R.Civ.P. 12(b)(6) plaintiffs must state a claim upon which relief can be granted or the complaint may be dismissed with prejudice as a matter of law. A motion to dismiss under Rule 12(b)(6) “is viewed with disfavor and is rarely granted.” When considering a motion to dismiss for failure to state a claim, “all factual allegations in the complaint must be taken as true and construed favorably to the plaintiff.” The United States Supreme Court has elaborated: Nothing in Rule 12(b)(6) confines its sweep to claims of law which are obviously insupportable. On the contrary, if as a matter of law “it is clear that no relief could be proved consistent with the allegations,” Hishon, supra, 467 U.S. at 73, 104 S.Ct. at 2232, a claim must be dismissed, without regard to whether it is based on an outlandish legal theory or on a close but ultimately unavailing one. V. ANALYSIS: FINDINGS OF FACT; CONCLUSIONS OF LAW A. Summary of the Allegations Ethex’s motion for preliminary injunction is based on its false advertising claim and alleges that Healthpoint and its sales representatives have provided false and misleading information that: (1) Ethezyme cannot be a “ ‘generic’ or ‘alternative’ to Aceuzyme under federal law because [Ethezyme has] not been approved by the Federal Food and Drug Administration (‘FDA’) as ‘therapeutically equivalent;’ ” (2) “Ethezyme is unsafe and ‘potentially life threatening’ because it contains sodium metabisulfite;” (3) “pharmacists may be'held liable for substituting Ethezyme for Accuz-yme;” (4) “severe reactions have occurred among several patients using Ethez-yme;” (5) “debridement of wounds with Ethez-yme is not as good as with Accuz-yme;” (6) “Ethex puts out inferior drugs;” (7) “Ethezyme is worthless;” (8) “the papain in Ethezyme is an insufficient quantity;” (9) “it is necessary to store Ethezyme at a cooler temperature than is required for Aceuzyme;” (10) “Ethezyme is not rated implying ... that there is some requirement for Ethezyme to be AB rated, while failing to state that Aceuzyme is not approved by the FDA as a new drug;” and (11) “a patient in the St. Louis area suffered anaphylactic shock.” In addition, Ethex alleges that “Accuz-yme’s label is false, misleading and deceptive because it claims that Aceuzyme has 1.1 x 106 USP units of papain activity when in fact it has substantially less.” Ethex further alleges that such labeling is misbranding in violation of the Food, Drug and Cosmetic Act (“FFDCA” or “FDCA”). With regard to the alleged false representations and misbranding, Ethex requests the Court to order Health-point to: correct the false and misleading information Healthpoint has provided about Aecuzyme, Ethezyme, and Ethex; recall all packages of Aecuzyme containing “less than 90 percent (%) of the papain activity claimed on its label;” and inform all past and future purchasers of Aecuz-yme that the product “has not been produced in accordance with current good manufacturing practices and that the level of papain activity in Aecuzyme is likely to be” less than stated on the label. Healthpoint’s cross-motion for preliminary injunction is based on its false advertising and “palming off” claims and alleges that Ethex has made false and misleading statements that: (1) Ethezyme is a “generic form of, the same as, a substitute for, and alternative to, a therapeutic equivalent to or substitute for Aecuzyme ointment;” (2) “Ethezyme ointment is ‘the new standard of potency in papain/urea debriding ointments’ ” suggesting FDA approval as well as recognition for safety and efficacy; (3) “Ethezyme ointment has ‘full potency,’ i.e. more papain activity per gram than Aecuzyme;” (4) “ ‘the labeled potency claim for Healthpoint’s Aecuzyme product is being revised downward by 25%;” ’ (5) “Aecuzyme has ‘potency problems;’ ” (6) “Ethezyme ointment is ‘AB-rated’ ” implying that “Ethex has submitted, and that the FDA has approved an abbreviated new drug application (‘ANDA’);” (7) Ethezyme is a “scientifically advanced alternative” or a “high quality ... alternative;” (8) “Ethezyme ointment works ‘better and faster;’ ” (9) “Healthpoint is obligated to change its trade name and National Drug Code (‘NDC’) number;” and (10) “Healthpoint had endorsed Ethez-yme as working faster and better than the Aecuzyme product.” Healthpoint requests the Court to order Ethex to cease inducing consumers to substitute Ethezyme for Aecuzyme and to order that future Ethezyme product packaging contain a notice that Ethezyme is not to be substituted for Accuzyme. Ethex’s motion to dismiss or for stay pending the outcome of an FDA investigation argues that “Healthpoint possesses unclean hands requiring dismissal of all claims or the claims against Ethex should be stayed pending an ongoing FDA investigation into the misbranding of Health-point’s Accuzyme product.” Ethex notes that Healthpoint seeks injunctive relief on each of its causes of action and argues that the defense of “unclean hands” is available in actions for false advertising, unfair competition, trademark infringement and dilution when equitable relief is sought. Ethex alleges that Healthpoint “misbrand-ed” Accuzyme, representing on its label that it contained papain at a given level but admitting that the actual potency of papain was at a different level, overstating the papain level to consumers and duping would-be competitors into replicating the labeled strength of papain. Ethex argues that this conduct related to the mis-branding, which requires no FDA interpretation, is inequitable conduct relating to Accuzyme which precludes Healthpoint from receiving equitable relief. Alternatively, Ethex argues that if the Court should agree with Healthpoint that a determination of the falsity of the Accuzyme labels rests in the hands of the FDA, then, under the doctrine of primary jurisdiction, tile entire case should be suspended pending action by the FDA. Finally, Ethex argues that if it is true, as Healthpoint argues, that the FDA has primary jurisdiction over alleged misrepresentations by Accuzyme’s label, then the FDA should also have primary jurisdiction over Health-point’s allegations that Ethex falsely represented that Ethezyme was a generic equivalent to, alternative for, and could be substituted for Accuzyme. If so, plaintiff cannot demonstrate a prima, facie case of federal or common law false advertising without the Court “usurp[ing] the FDA’s responsibility of interpreting the FDCA and its own regulations.” Healthpoint’s response and cross-motion to dismiss argues, in sum, that Ethex’s mislabeling claims should be dismissed because, among other reasons, Ethex’s claim and unclean hands defense requires the court to interpret FDA regulations and Ethex has failed to show a causal connection between the alleged mislabeling and its own sales position to show a Lanham Act violation. Healthpoint also argues that Ethex has failed to state a cause of action on its claim that Healthpoint’s studies do not meet the FDA’s requirement for proof of safety and efficacy since the Court should consider and apply, not FDA standards, but whether there is some support for its position to defeat a Lanham Act claim. Healthpoint also argues that its statements to consumers about the law applying to generic drugs were based on FDA regulations, advertising guidance and warning letters and may not form the basis of a Lanham Act claim. Healthpoint argues that the Court need not defer to the FDA in resolving Healthpoint’s unfair competition claims because it is the responsibility of the FDA to insure that drugs are safe, effective and not misbrand-ed but it is the Court’s responsibility to protect firms from unfair competition. Finally, Healthpoint argues that Ethex’s unclean hands defense should be dismissed with prejudice because if the Court declines to consider Healthpoint’s Lanham Act claims based on alleged mislabeling the Court will be giving Ethex a temporary license to “swindle and defame” Healthpoint by claiming and implying Eth-ezyme may be substituted for Accuzyme. Healthpoint asks that Ethex’s mislabeling and unclean hands be dismissed because they require interpretation of FDA regulations to succeed. B. Dismissal or Stay of Healthpoint’s Claims Pending FDA Investigation As a threshold matter, the Court addresses Ethex’s argument that all of Healthpoint’s claims should be dismissed or stayed and Healthpoint’s counter-argument that Ethex’s mislabeling and unclean hands claims should be dismissed because they require direct interpretation of FDA rules and regulations. Aspects of these arguments are relevant to an assessment of preliminary injunction burdens such as likelihood of success on the merits and irreparable harm, but a separate discussion of the primacy of FDA jurisdiction is undertaken here in light of the separately filed motion to dismiss. In brief, Ethex argues that the FDA is conducting an investigation both of the alleged misbranding of Accuzyme and of Ethex’s alleged misrepresentations in the marketing of Ethezyme. Ethex also argues that the doctrine of “unclean hands” prevents Healthpoint from receiving in-junctive relief and requires the dismissal of all of Healthpoint’s claims due to admitted mislabeling. Alternatively, Ethex argues that Healthpoint’s claims of false advertising under the Lanham Act and common law should be dismissed because Healthpoint’s prima facie case is dependent upon determinations that the FDA should make. Alternatively, Ethex argues that Healthpoint’s allegations that Ethex improperly markets Ethezyme as a generic to and equivalent of Accuzyme should be stayed pending completion of an FDA investigation. Finally, Ethex argues that all of Healthpoint’s claims should be dismissed because Healthpoint has not demonstrated that Accuzyme is being marketed lawfully. In response and in sum, Healthpoint argues that the motion to dismiss or stay should be denied because Healthpoint’s false advertising claims do not require the interpretation of FDA regulations. Healthpoint moves for the dismissal of Ethex’s unclean hands and mislabeling claims because they do require the interpretation of FDA regulation. This is not the first time in which a federal court has been asked to determine whether a Lanham Act or related common law claim may proceed or whether such a claim is merely an impermissible vehicle for the assertion of a violation of the FDCA. Section 337(a) of the FDCA provides that “all such proceedings for the enforcement, or to restrain violations of [the Act] shall be in the name of the United States.” Construing this language and considering related arguments, courts have held that the FDCA does not create a private right of action to enforce or restrain the provisions of the FDCA or FDA regulations. Analogously, other courts have held that a party should not be allowed to use the Lanham Act or a related common law cause of action to assert, in effect, a violation of the FDCA. Although the parties have not cited any Fifth Circuit precedent on point, other courts have held that allegations of false and misleading advertising that “stray[ ] too close to the exclusive enforcement domain of the FDA” are impermissible attempts to circumvent section 337(a)’s denial of a private right of action. A brief discussion of a few of the cases addressing this issue is instructive as to the general framework for drawing the boundary between the FDCA and FDA enforcement domain, on the one hand, and permissible Lanham Act and related common law claims, on the other. In Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., plaintiff brought a Lanham Act claim, alleging that defendant falsely listed an ingredient as “inactive” on a cough syrup label when the FDA required that the ingredient be labeled as “active”. Defendant argued that plaintiffs claim was a misbranding violation of the FDCA for which there was no private right of action. The Third Circuit affirmed the district court’s denial of a preliminary injunction, agreeing with the district court that plaintiff had not demonstrated likelihood of success on the merits; because the FDA had not found conclusively that the ingredient should be labeled as “active” under FDA regulations, plaintiff had not shown that the labeling was false. The Third Circuit stated: [plaintiffs] position would require us to usurp administrative agencies’ responsibility for interpreting and enforcing potentially ambiguous regulations. Jurisdiction for the regulation of OTC drug marketing is vested jointly and exhaustively in the FDA and the FTC, and is divided between them by agreement. Neither of these agencies’ constituent statutes creates an express or implied private right of action and what the [FDCA] and the FTC Act do not create directly, the Lanham Act does not create indirectly, at least not in cases requiring original interpretation of these Acts or their accompanying regulations. The Court held that “[b]ecause agency decisions are frequently of a discretionary nature or frequently require expertise,” the court would not preempt the exercise of that discretion by directly applying FDA regulations through the Lanham Act to address what was, in effect, a misbrand-ing claim, governed by FDA regulations, concerning a subject matter that the FDA had not yet resolved. In Mylan Laboratories, Inc. v. Matkari, the Fourth Circuit reversed the dismissal of plaintiffs Lanham Act claim under Rule 12(b)(6) that defendants had falsely represented that their product was the “bioequi-valent” of plaintiffs product and upheld the dismissal of plaintiffs claim that defendants had falsely represented that their drugs had been approved by the FDA merely by the act of offering them in the market. In regard to the false representations, the district court had dismissed Mylan’s Lanham Act claims on the ground that the complaint failed to alleged specifically that Matkari’s drugs were not bioe-quivalent. The Fourth Circuit held that the district court “correctly noted that, in order ultimately to succeed on its Lanham Act count, Mylan will have to show more evidence than mere proof that defendants’ claims were supported by unpersuasive test results.” But, the Fourth Circuit reversed this dismissal, holding that Mylan’s allegations that defendant had falsely represented that its product was “bioequiva-lent” to Mylans’s counterpart and “other approved generic equivalents,” was entitled to an “AB” rating from the FDA, and that the product was the “generic alternative” to Mylan’s product were “sufficiently particularized allegations of false or misleading representations to sustain for now” the Lanham Act claims. But, the Fourth Circuit upheld the dismissal of Mylan’s claim that the defendant had falsely represented its drug was approved by the FDA by placing the drug on the market because such a claim, without evidence of any advertising by defendant, was an impermissible attempt to enforce the FDCA and FDA regulations. The Fourth Circuit stated: We agree with defendants that permitting Mylan to proceed on the theory that the defendants violate § 43(a) [§ 1125(a) of the Lanham Act] merely by placing their drugs on the market would, in effect, permit Mylan to use the Lanham Act as a vehicle by which to enforce the [FDCA] and the regulations promulgated thereunder. An attempt, by ingenious pleading, to escape one principle of law by making it appear that another not truly appropriate rule is applicable appears to have been attempted. Mylan in short, is not empowered to enforce independently the FDCA. In order to state a proper claim for relief under .. the Lanham Act, Mylan was required to point out some claim or representation that is reasonably clear from the fact of the defendants’ advertising or package inserts. That it did not do. In Eli Lilly & Co. v. Roussel Corp., Eh Lilly brought suit against competitors selling bulk cefaclor, an antibiotic, and against other drug companies that purchased the cefaclor for resale in retail dosage units. For many years, Lilly was the only manufacturer of cefaclor but after Lilly’s patent expired, a competitor sought FDA approval to sell bulk cefaclor. The FDA approved the abbreviated drug application required in that instance (and “AADA”). Later, the FDA informed the competitor that it had found that its AADA contained false and misleading information. Eli Lilly brought suit, alleging a Lanham Act claim, among others, alleging that the manufacturer obtained FDA approval by making false statements to the FDA and that defendants misleadingly used terms such as “generic,” “cefaclor,” or “alternative to brand-name drugs” in product inserts and marketing materials implying that their retail dose of cefaclor was safe and effective. The Court dismissed Eli Lilly’s Lanham Act claim for failure to state a claim, noting that failure to disclose facts is not actionable under the Lanham Act; that if mere marketing a drug is an implied representation that the drug has been approved by the FDA, such a claim is an FDCA violation to be decided by the FDA; and that whether use of the terms “generic,” “cefaclor,” “alternatives to brand-name drugs,” and “safe and effective” implied FDA approval similarly “rely on interpretations of the FDCA” and were not alleged to be affirmative misrepresentations standing on their own. The Court emphasized that “Lilly has not alleged that defendants made false representations as to the quality, bioequivalency or safety of its products. Lilly has not alleged that defendants’ cefaclor was not generic cefaclor, or that it was not bioequi-valent to Ceclor or that it was not safe and effective.” The Court held that, as in Mylan, such “broad and conclusory allegations” do “not allege that defendants misrepresented the quality of their products, but are based on defendants’ misrepresentations that they properly obtained FDA approval.” Absent an express, false statement that the FDA had approved the drug or other false statements about the product, false implications of approval are not actionable. In Grove Fresh Distributors, Inc. v. Flavor Fresh Foods, Inc., (“Grove Fresh I”), plaintiff alleged that because defendant’s orange juice contained additives and adulterants, the representation that the product was “100 % orange juice from concentrate” was false. The district court denied defendants’ motion to dismiss plaintiffs Lanham Act claim, holding that it was not an impermissible attempt to recover damages for the misbranding of food in violation of the FDCA: Grove Fresh relies on the FDA regulation [that defines “orange juice from concentrate”] merely to establish the standard or duty which defendants allegedly failed to meet. Nothing prohibits Grove Fresh from using the FDCA or its accompanying regulations in that fashion.... Grove Fresh does not base its claim solely on the FDCA or FDA regulations. Grove Fresh alleges that defendants have violated section 43(a) of the Lanham Act. Even without the FDA regulation defining “orange juice from concentrate,” Grove Fresh could attempt to establish a violation of section 43(a). Grove Fresh would simply need to provide other evidence establishing the proper market definition of “orange juice from concentrate.” The court allowed plaintiff to bring a Lan-ham Act cause of action for affirmatively misrepresenting facts -whether the orange juice was “pure” under a commercial definition — without interpreting any FDA regulation. Two months later, the same Court (before a different judge) in Grove Fresh Distributors, Inc. v. Everfresh Juice Co., (“Grove Fresh II”), held that “[w]here Congress has precluded private causes of action under the FDCA,-we find it difficult to justify the use of the FDCA to establish a crucial element of a private cause of action under the Lanham Act.” To sustain a Lanham Act claim the court held that Grove Fresh would have to “provide other evidence establishing the proper market definition of ‘orange juice from concentrate.’ ” In Summit Technology, Inc. v. High-Line Medical Instruments Co., (“Summit I”) the district court dismissed plaintiffs Lanham Act and common law unfair competition claims that defendants had failed to disclose that their ophthalmological laser systems had not been approved by the FDA. The Court held that because the FDA had not yet determined that defendants’ systems needed approval, allowing plaintiffs Lanham Act claim to proceed would force the Court to decide the legality of defendants’ conduct before the FDA had a chance to do so. After plaintiff amended its complaint, the court, in Summit II, reiterated that “absent an affirmative representation that a drug has been officially approved by the FDA, a Lanham Act claim alleging that the defendant had failed to disclose FDA non-approval could not stand.” The Court explained that an affirmative misrepresentation that a product has “FDA approval” ... is actionable because it clearly misstates a fact and does not require an interpretation or application of FDA regulations .... [A] court can test the truth of the statement “FDA approval” without any need to interpret FDA regulations. On the other hand, the Court held that “to test the truth of defendant’s apparent claim that it can legally import the Summit lasers, the Court would be required to perform an ‘original interpretation’ of the FDA regulations governing this area,” an exercise the Court was not willing to undertake. In Braintree Laboratories, Inc. v. Nephro-Tech, Inc., a district court held that allegations the defendant falsely described and misbranded its product as a “dietary supplement” in violation of § 1125(a) and common law unfair competition should be dismissed because it is for the FDA and not the court to decide whether defendant’s product is properly classified as a “dietary supplement” under the FDCA and FDA regulations. This court was unwilling to consider evidence establishing an independent lay understanding of the term “dietary supplement” even though Braintree alleged that Nephro-Tech’s labeling of its unapproved product as a “dietary supplement” was false “in the ordinary sense because the calcium in the product is not intended to be absorbed.” In sum, courts have held not only that a plaintiff may not seek to enforce directly the FDCA through the Lanham Act but also that a plaintiff may not maintain a Lanham Act claim if the claim requires direct application or interpretation of the FDCA or FDA regulations. “[S]ueh a claim would allow a private litigant to interfere with the FDA’s own investigatory time-table and prosecutorial decision-making ... [and] .. .would force the Court to rule directly ‘on the legality of ... conduct before the FDA has had a chance to do so.’ ” The District Court should not “determine presumptively how a federal agency will interpret and enforce its own regulations.” To do so would violate Congressional intent that the FDA have discretion to enforce the FDCA and implementing regulations. But, as in Mylan, Grove Fresh I, and Summit, some courts have held that certain false statements are actionable under the Lanham Act “even if their truth may be generally within the purview of the FDA.” There is no single, bright-line test to distinguish sustainable from non-sustainable claims. In this case, as summarized above, Healthpoint’s motion for preliminary injunction, based on its claims of false advertising and “palming off,” addresses Ethex’s allegedly false representations that Ethezyme, in sum, “is superior to or an equivalent or alternative to or can be substituted or interchanged with” Accuzyme. Ethex’s motion for preliminary injunction, based on its false advertising claim, addresses Healthpoint’s allegedly false representations that, in sum, Ethezyme is not an alternative to, is not as effective as, or is inferior to Accuzyme or is unsafe; or that Ethezyme requires federal approval. The question for the District Court is whether the adjudication of these claims, or aspects of the these claims, require the direct application of the FDCA or rely on the FDCA or FDA regulations or policy to establish a critical element of a claim or defense. The FDA has primary jurisdiction to decide Ethex’s claim that Healthpoint has misbranded its product due to allegedly incorrect labeling information regarding the papain activity of Accuzyme. Ethex describes the allegedly false information on Accuzyme’s label as constituting “the offense of misbranding” and appears to concede in an alternative argument in its motion to dismiss that such matters could be considered to be within the primary jurisdiction of the FDA. Ethex also has argued that the claim that Healthpoint has falsely advertised Accuzyme because its label does not match the ingredients in the actual product can be severed from the misbranding claim and can be considered as false advertising under the Lanham Act. But, such a claim involves all the facts and arguments to be determined in a misbranding enforcement action, matters within the sole jurisdiction of the FDA. As in Grove Fresh II, a party may not use the FDCA to establish a crucial element of a Lanham Act claim. To the extent that a Lanham Act claim can be fashioned — by considering the Accuzyme label as an “advertisement” and representation of its ingredients — as reflected below, Ethex has not established a likelihood of succeeding on the merits of showing that there is a causal connection between the alleged mislabeling and any loss of sales or good will, a necessary element of a Lanham Act false advertising claim. Ethex has not produced any evidence that shows anyone prescribed or dispensed Accuzyme based on its label claim of papain or that Ethez-yme — apparently exclusively marketed as an alternative to Accuzyme — was deprived of a single substitution based on Aceuz-yme’s label claim of papain. Similarly, arguments concerning what federal law does or does not require for Ethyzyme and Accuzyme to be marketed legally require the direct application and interpretation of FDA regulations. Accuzyme has presented several arguments to show it is legally marketed. The parties do not dispute that both Ac-cuzyme and Ethezyme are “drugs” within the meaning of the FDCA. There is no evidence that either Accuzyme nor Ethez-yme has been the subject of a NDA or ANDA or that Ethex could file an ANDA based on Ethezyme’s purported equivalence to Accuzyme (because Accuzyme is not the subject of an approved NDA).The FDA has not taken action to remove Ac-cuzyme from the market, even though Ac-cuzyme has been on the market since 1996, Healthpoint has reported its marketing of Accuzyme in its annual reports to the FDA, the FDA has an open investigation of misbranding of Accuzyme the FDA recently inspected the San Antonio plant in connection with the investigation. It is clear the FDA has had and continues to have the opportunity to decide if further enforcement action is appropriate. Ethezyme’s arguments as to lawfulness advanced in connection with the preliminary injunction hearing are weaker, but, again, the FDA has had an open investigation since approximately October 2000 regarding Ethex’s terming Ethezyme an “alternative”to Accuzyme, implying that Ethezyme is a “generic” of the “brand” Accuzyme, and failing to include a sodium metabisulfite warning in its August, 2000 advertisement of Ethez-yme in the “U.S. Pharmacist” and has not taken enforcement action to remove it from the market. It is for the FDA to exercise its discretion to determine whether Accuzyme and Ethezyme are on the market lawfully, whether it be because they are grandfathered or otherwise qualify for any exception to the FDA pre-clearance process. Resolution of these questions in court would require the “direct interpretation and application of the FDCA ... [which] ... are more appropriately addressed by the FDA, especially in light of Congress’s intention to repose in that body the task of enforcing the FDCA.” As in Summit I and II, the District Court should not “ ‘determine preemptively how a federal agency will interpret and enforce its own regulations.’' ” Other underlying, significant questions — such as whether Accuzyme is a “grandfathered” substitute for Panafil or Panafil White; whether Ethezyme is a “generic” to Accuzyme; whether either Accuzyme or Ethezyme should be required to file a new drug application (“NDA”) or abbreviated new drug application (“ ANDA”); whether Ethezyme requires FDA approval or rating; whether Health-point must change Aecuzyme’s trade name and NDC number now that Accuzyme’s label has changed; whether sodium meta-bisulfite should be listed as an active ingredient in Ethezyme; whether Ethez-yme is not an alternative to Accuzyme because it contains sodium metabisulfite; whether Ethezyme or Accuzyme need to be tested; whether Healthpoint’s test of Accuzyme are sufficient under FDA requirements to show safety and efficacy —are issues which are committed to the FDA and the District Court should decline to address them. Nevertheless, the parties have made numerous other claims that, based on the current record, do not appear to require application or interpretation of FDA regulations or include the FDCA as a “crucial element” of a Lanham Act claim or be tantamount to the private enforcement of the FDCA. Based on the current record it would appear that the following possible claims may be addressed through the Lanham Act, whether: the products are the “same” based on simple comparison of labels; whether either product has falsely claimed it has been approved and/or rated by the FDA; whether Ethezyme’s claim that it is the “new standard” for urea products is a misleading claim of superiority; whether Ethex has falsely stated that Ethezyme works better or faster than Accuzyme; whether Ethex has falsely stated that Ethezyme has “full potency” but Accuzyme does not; whether Ethex has falsely stated that Ethezyme is a scientifically advanced or high quality alternative for Accuzyme; whether Ethex has falsely claimed that Accuzyme has potency problems or “the labeled potency claim for Eealthpoint’s Accuzyme product is being revised downward by 25%;” whether Healthpoint falsely claimed that Ethezyme must be stored “at a cooler temperature than is required for Accuzyme;” whether Healthpoint falsely claimed that a St. Louis area patient “suffered anaphylactic shock from Ethez-yme;” whether Healthpoint has falsely stated that Ethezyme has caused severe reactions among patients; whether Healthpoint has falsely stated that the pa-pain in Ethezyme is an insufficient quantity; and whether Healthpoint has falsely claimed that Ethex puts out inferior products. These are claims that, based on the current record, appear to be able to be resolved through a determination of facts and without interpretation of FDA regulations. Perhaps ironically, these more narrow issues did not predominate in the live testimony at the preliminary injunction hearing. Rather, the parties chose to focus on the contention that appears to be at the heart of this case — whether Ethezyme may be advertised as an “alternative” or “equivalent” to and suggested substitute for Accuzyme. Healthpoint argues, in sum, that Ethex has not demonstrated that Ethezyme is therapeutically equivalent or pharmaceutically equivalent or bioequivalent to Accuzyme and, therefore, Ethex should not be allowed to suggest that Ethezyme is freely substitutable, under most state laws, as a “ge-nerieally” equivalent product. Health-point argues that Ethex is free to market and advertise Ethezyme and to encourage physicians to write prescriptions for Ethezyme, but not to place comparative advertisements that falsely suggest that it may be substituted as an equivalent for Accuzyme. To the contrary, Ethex argues that Healthpoint should not be permitted to represent or imply that Ethezyme is not therapeutically equivalent, because Healthpoint has no studies to show that it is not. Ethex argues that to allow Healthpoint to pursue such a claim would require Ethex “to prove bioequivalence to Accuzyme, ... [and] ... in effect, Ethex would be required to submit an ANDA to the FDA for Ethez-yme when there is no procedure that would allow for such a filing.” In other words, Ethex argues that if it must provide evidence in District Court to demonstrate that it is a “generic” or “equivalent” or “alternative” to Ethyzyme in order to show it may correctly suggest substitution, the District Court, in effect, would be overruling the “new drug” exemption Ethezyme apparently enjoys and interfering with the FDA’s primary jurisdiction. Ethex argues that it should be free to market Ethezyme as an “alternative” to and substitute for Accuzyme, leaving it up to licensed pharmacists and practitioners to determine if substitution is proper under state law and based on patient needs. It seems clear that in addressing claims of “equivalent to” or “alternative to,” the Court should not change the FDA’s definitions of such related terms of art as “pharmaceutical equivalents,” “therapeutic equivalents,” “bioequivalence” and “pharmaceutical alternative.” New definitions of FDA terms would undercut national uniformity regarding federal laws regulating the drug market or would confuse the public and undermine confidence in the drug supply in general and generic drugs in specific. Although Lanham Act or related common law claims that concern whether Ethezyme is “the same as” Accuz-yme — to the extent that determination requires a simple comparison of ingredients and does not entail a decision on whether sodium metabisulfite should be listed as an active ingredient -appear to be properly before the District Court, a determination of whether Ethezyme is “equivalent” to Accuzyme appears to be inextricably linked to the determination of whether Ethezyme is being marketed lawfully, a matter within the exclusive enforcement domain and “peculiar expertise” of the FDA. Similarly, “the task of identifying in the first instance whether one drug is the generic equivalent of another” belongs to the FDA, “the government agency with extensive technical and scientific expertise in the area.” The term “alternative” is less problematic, perhaps because the parties appear to agree that Ethezyme likely is a “pharmaceutical alternative” to Accuz-yme, as defined by the FDA, and because “alternative” does not imply identity or equivalence. Nevertheless, the primary jurisdiction of the FDA would not appear to bar the District Court from deciding Health-point’s false advertising claim that Ethex falsely advertised Ethezyme by making specific false or misleading representations (e.g., same active ingredients in same amounts). There is a distinction between respecting the FDA’s primary jurisdiction to determine in the first instance whether a drug is lawful, “generic,” “bioequivalent,” “therapeutically equivalent,” or “pharmaceutically equivalent” and, on the other hand, a Lanham Act claim that a false statement has been made about a product. Even though the FDA has not required Ethex to demonstrate its equivalence to Aceuzyme, Ethex is not free to make false or misleading statements about its product. To hold to the contrary would mean that an administrative scheme could eviscerate a Lanham Act or related claim over which the agency has no jurisdiction. For example, if Ethex represents that Ethezyme has “the same active ingredients in the same quantities as Accuz-yme,” the consumer and competitors have a right to expect that the representation has factual support. Conversely, the FDA’s primary jurisdiction also should not bar the District Court from deciding Ethex’s claim that Healthpoint made false or misleading statements about Aceuzyme (e.g., Healthpoint has claimed or implied that Aceuzyme has FDA approval and that Ethezyme needs FDA approval or an “AB” rating to be substitutable). Either side’s key false advertising contentions are not merely claims that a drug falsely implied it has been approved by the FDA without any additional allegation of falsity; rather, each is a claim of false or misleading comparisons between two specific products in the context of comparative advertising and promotion relating to whether one drug can be substituted for another under state law. As in Mylan, dismissal of such claims at this stage would be inappropriate. In sum, it is recommended that issues that require direct application or interpretation of the FDCA or its implementing regulations or FDA policies should not be addressed by the District Court; neither Ethex nor Healthpoint have demonstrated likelihood of succeeding on the merits on any issue that requires the District Court to directly apply or interpret the FDCA, implementing regulations or FDA policies. On the other hand, at this stage of the pleading, it appears that other issues are able to be resolved without the direct application or interpretation of the FDCA, implementing regulations or FDA policies. Whether or not either side has demonstrated a likelihood of success on any of those issues is addressed below. It is recommended that Ethex’s motion to stay all claims indefinitely pending the conclusion of the FDA’s investigation the misbranding issue or the pending the determination of all FDA “core issues” which “permeate every aspect of this case” should be denied. There has been no showing that any of these issue would resolve this lawsuit unless, of course, the FDA were to decide that Aceuzyme and Ethezyme were on the market illegally. Further, it is recommended that the portion of Healthpoint’s cross-motion to dismiss that requests dismissal of Ethex’s claim of misbranding should be granted. Ethex’s motion to dismiss all of Healthpoint’s claims due to unclean hands and Ethex’s alternative request that Healthpoint be denied any in-junctive relief due to unclean hands as well as the remaining portion of Healthpoint’s motion to dismiss that requests the dismissal of Ethex’s unclean hands claims or defenses are discussed below. C. Unclean Hands The doctrine of unclean hands “closes the doors of a court of equity to one tainted with inequitableness or bad faith relative to the matter in which he seeks relief, however improper may have been the behavior of the defendant.” Although equity does not demand that the parties “have led blameless lives ... it does require that they shall have acted fairly and without fraud or deceit as to the controversy in issue.” For the doctrine to apply, a party’s conduct does not need to be one punishable as a crime or one that would justify legal proceedings of any sort. “Any willful act concerning the cause of action which rightfully can be said to transgress equitable standards of conduct is sufficient cause” for the court to invoke the doctrine. The wrongful acts upon which the claim of unclean hands is premised must “in some measure affect the equitable relations between the parties in respect of something brought before the court for adjudication.” Plaintiffs alleged wrongdoing will not bar relief unless the defendant establishes personal injury resulting from plaintiffs conduct. The unclean hands doctrine “does not purport to search out or deal with the general moral attributes or standing of a litigant.” • The doctrine of unclean applies to preliminary injunctions and affords the equity court broad discretion in rejecting an unclean litigant’s claims. However, the doctrine should “not be used as a loose cannon, depriving plaintiff of an equitable remedy ... merely because he is guilty of unrelated misconduct.” In applying, the unclean hands doctrine, the court must consider the situation as it existed at the time of the suit. 'Equity denies relief “where the plaintiff is misrepresenting to the public the nature of his product either by the trademark itself or by his label.” Unclean hands is a defense to a Lanham Act claims such as trademark infringement and unfair competition. As the Supreme Court said in Clinton E. Worden & Co. v. California Fig Syrup Co.: [W]hen the owner of a trade-mark applies for an injunction to restrain the defendant from injuring his property by making false representations to the public, it is essential that the plaintiff should not in his trade-mark, or in his advertisements and business, be himself guilty of any false or misleading representation; that if the plaintiff makes any material false statement in connection with the property which he seeks to protect, he loses his right to claim the assistance of a court of equity; that where any symbol or label claimed as a trade-mark is so constructed or worded as to make or contain a distinct assertion which is false, no property can.be claimed on it, or, in other words, the right to the exclusive use of it cannot be maintained. Equity affords no protection to a party who is guilty of “materially false or misleading advertisements or business relative to the trademark.” A Lanham Act defendant must show that “plaintiffs conduct is inequitable and that the conduct relates to the subject matter of [plaintiffs] claims.” In a claim for false advertising, the unclean hands of the plaintiff must relate to the same product the defendant allegedly falsely advertised. A court may reject the doctrine where the “failure to grant an injunction would only increase the damage inflicted on the buying public.” The unclean hands doctrine should not bar Lanham Act claims when the doctrine is premised on allegations of noncompliance with the FDCA because such a use of the doctrine would essentially permit a private enforcement action — a power reserved for the FDA. Courts have applied the doctrine of unclean hands to bar equitable relief in cases involving trademark infringement, false advertising, and unfair competition. In Strey v. Devine’s, the Seventh Circuit found that plaintiffs use of the designation “Dr.” on his product label, although plaintiff was not a licensed physician, could mislead the public into believing the product was prescribed by a doctor. Additionally, the court found that under the FDCA, plaintiffs product was misbranded because the label did not list all ingredients. The Seventh Circuit affirmed the dismissal of plaintiffs claims for trademark infringement and unfair competition, finding the claims barred by unclean hands. In Haagen-Dazs, Inc. v. Frusen Gladje Ltd., Haagen-Dazs claimed that the defendant had violated the Lanham Act by packaging their product in a way to benefit from Haagen-Dazs’ exclusive marketing technique. Among the complaints was the allegation that the defendant’s container was intended to deceive the public into believing the product was produced in Sweden when the product actually derived from an American recipe and was produced in Pennsylvania. In denying the preliminary injunction, the court found that Haagen-Dazs’ hands were equally unclean because its container also gave the impression the product was from Scandinavia when it was actually of domestic origin. Other courts have rejected the unclean hands defense as applied to Lanham Act cases. In Levi Strauss & Co. v. Shilon, the defendant had offered for sale to a Levi Strauss undercover investigator unbranded and untagged jeans bearing Levi trademarked stitching. He provided the investigator with the Levi tags and labels which could be sewn into the jeans at locations outside of the United States. The defendant argued that Levi Strauss’s Lanham Act claims for trademark infringement were barred by the doctrine of unclean hands because the company’s investigator had entrapped him. The Ninth Circuit affirmed the district court’s finding that unclean hands did not bar Levi Strauss’s Lanham Act claims because the defendant had not proved entrapment. In Fuddruckers, Inc. v. Doc’s B.R. Others, Inc., Fuddrucker’s sought to enjoin defendant’s trade dress infringement. The district court denied defendant’s request for a jury instruction regarding the unclean hands doctrine on the theory that Fuddrucker’s misled the public by describing its hamburger meat as “ground steak.” Affirming the district court’s refusal to instruct, the Ninth Circuit noted that unclean hands is a defense to a Lan-ham Act claim and explained that Fud-drucker’s representations the meat was “ground steak” were immaterial in a trade dress infringement claim. In Inmuno Vital, Inc. v. Golden Sun, Inc., a summary judgment ease, Golden Sun raised the affirmative defense of unclean hands based on Inmuno’s non-compliance with FDCA regulations; advertising that a percentage of product profits would be donated to medical research; misbranding; and advertising that the product would cure certain diseases. A Florida district court refused to apply the doctrine, finding that Golden Sun had failed to establish that the product did not contribute to cures and that Inmuno’s statements of contributions to medical research were essentially true. In addition, the court refused to find misbranding when the United States Patent and Tr