In re Elysium Health-Chromadex Litig., 17 Civ. 7394 (CM)

354 F.Supp.3d 330

IN RE ELYSIUM HEALTH-CHROMADEX LITIGATION

17 Civ. 7394 (CM)

United States District Court, S.D. New York.

Signed January 3, 2019

As Amended February 7, 2019

Benjamin David Pergament, Esterina Giuliani, Kristin Lynne Keranen, Joseph N. Sacca, Baker & Hostetler LLP, Michael Mary Powell, Skadden, Arps, Slate, Meagher & Flom LLP, New York, NY, for Plaintiff.

Alan Levine, David Hillel Kupfer, Laura Grossfield Birger, Cooley LLP, New York, NY, Anthony M. Stiegler, Cooley L.L.P., San Diego, CA, Peter J. Willsey, Cooley LLP, Washington, DC, Thomas M Hadid, Santa Monica, for Defendant.

AMENDED DECISION AND ORDER GRANTING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

McMahon, C.J.:

On September 27, 2017, Plaintiff Elysium Health, Inc. ("Elysium") filed a complaint ("Complaint") against Defendant Chromadex, Inc. ("CMDX"), alleging violations of § 43(a) of the Lanham Act, as well as state law claims of trade libel, deceptive business practices under New York General Business Law § 349, and tortious interference with prospective economic relations.

Presently before the Court is CMDX's Motion for Summary Judgment based on a claim of immunity under the Noerr - Pennington doctrine.

For the reasons that follow, CMDX's Motion is GRANTED.

I. Background

The Court presumes the parties' familiarity with the details of this case, which were outlined in the Court's prior order (see Dkt. No. 44), and writes merely to provide a brief recitation of the facts that are pertinent to Defendant's present Motion.

Elysium sells a product called Basis, an anti-aging dietary supplement comprised of two ingredients, pterostilbene ("PT") and nicotinamide riboside ("NR"). (Declaration of Troy Rhonemus ("Rhonemus Decl.") ¶ 56, Dkt. No. 51.) CMDX develops, sells, and produces these ingredients in bulk, licensed as NIAGEN® and pTeroPure®, for use in consumer products. (Id. ¶ 8.) CMDX formerly supplied Elysium with these ingredients, but their business relationship soured and ultimately ended in 2016. (See id. ¶¶ 58–60.) Thereafter, CMDX began selling TruNiagen, its own anti-aging NR product. (Id. ¶ 7.)

Beginning in approximately August 2017, Elysium manufactured a new version of Basis using NR and PT from an unknown supplier. (Id. ¶ 62.) Around this time, CMDX conducted in-house testing of the new version of Basis, which revealed that the new NR and PT ingredients used by Elysium were chemically different from NIAGEN® and pTeroPure®, and that Basis now contained toluene, an industrial solvent that potentially poses "serious health concerns" when ingested. (Id. ¶¶ 48, 62.) Thereafter, CMDX filed a citizen petition ("Citizen Petition" or the "Petition") with the FDA, asking the agency to make the following two determinations on the basis of CMDX's in-house testing of Basis;

i. That Elysium's Basis product is adulterated under 21 U.S.C. § 342(a) and (f) based on the undeclared presence of toluene in the product at the level of 96–144 mg/kg; and

ii. That Elysium's Basis product contains a new dietary ingredient under 21 U.S.C. § 350b for which Elysium had not submitted a New Dietary Ingredient Notification ("NDIN"), thereby rendering the product adulterated under §§ 342(f)(1)(B) and 350(a).

(Declaration of Joseph N. Sacca ("Sacca Decl.") Ex. 1 at 2, Dkt. No. 53 (Citizen Petition) (quotation marks omitted).)

In support of its requests, the Citizen Petition noted that the FDA has not set any allowable level of exposure to toluene through oral ingestion of a dietary supplement, and cited a 2015 Center for Disease Control ("CDC") publication touting the dangers of toluene. (Id. at 6.) CMDX also asked the FDA to "take all appropriate remedial action, including [ordering] that Elysium cease distribution of its Basis product and take other appropriate enforcement action, including seizure of violating products and an injunction against the manufacturers and distributors under 21 U.S.C. §§ 332 and 334." (Id. at 2.)

In response, Elysium filed a lawsuit on September 27, 2017, alleging that the Citizen Petition was false, misleading, and filed for the sole purpose of harming Elysium. (See Compl., Dkt. No. 1.) Elysium's Complaint articulated three bases in support of this contention.

First , it alleged that the levels of toluene that CMDX had claimed were contained in Basis were consistent with pharmaceutical standards set forth by the International Conference on Harmonisation if Technical Requirements for Pharmaceuticals for Human Use ("ICH"), a non-profit association under Swiss law that, as its name suggests, makes recommendations about harmonizing competing regulatory requirements for pharmaceutical products, and that the FDA regularly relies on these standards for dietary supplements where no other applicable standards exist. (Id. ¶¶ 54–55.)

Second , Elysium averred that, based on Certificates of Analysis ("COAs") provided by CMDX to its customers, CMDX's pTeroPure® contains similar levels of toluene, so CMDX could not actually have believed that Basis was unsafe or that the Citizen Petition could be successful on the merits. (Id. ¶ 65.)

Third , it contended that CMDX had no expectation that the FDA would grant its Citizen Petition because CMDX knew (or, as a regulatory consultant, should have known) that the FDA does not grant citizen petitions that seek the commencement of enforcement actions, including actions for seizure or injunctive relief. (Id. ¶¶ 37–44 (citing 21 C.F.R. § 10.30(k).)

On October 26, 2017, CMDX moved to dismiss the Complaint under Fed. R. Civ. P. 12(b)(6). As part of that motion, CMDX argued that, even if Elysium could state a viable claim for unfair competition, CMDX's filing of the Citizen Petition qualifies for protection under the Noerr - Pennington doctrine, which safeguards the First Amendment right to petition the government for a redress of grievances by immunizing citizens from liability attending to that right. (Mem. of Law in Supp. Def.'s Mot. Dismiss ("Def.'s MTD") at 4, Dkt. No. 20.) See also U.S. Const. amend. I. Elysium countered that CMDX's activity fell under Noerr - Pennington 's narrow "sham exception," which denies immunity for one's attempts to influence governmental action where doing so is a "mere sham to cover an attempt to interfere directly with the business relationships of a competitor." See E. R.R. Presidents Conference v. Noerr Motor Freight, Inc. , 365 U.S. 127, 144, 81 S.Ct. 523, 5 L.Ed.2d 464 (1961).

Meanwhile, on January 16, 2018, nearly four months after Elysium's Complaint was filed, CMDX submitted a supplemental citizen petition ("Supplemental Petition") to the FDA, which asked the FDA to:

i. Issue agency guidance or otherwise announce publicly that ICH guidelines do not apply to dietary supplements;

ii. Issue an order that NR is not reasonably expected to be safe if it contains new impurities, such as toluene, that have not been reviewed under the NDIN process; and

iii. Finalize its NDIN guidance and clarify its enforcement policy with respect to dietary supplement manufacturers that include a New Dietary Ingredient in their products without complying with the notification requirements that are outlined in Section 413(a) of the 2016 U.S. Food and Drug Administration Act.

(Rhonemus Decl. ¶ 74, id. Ex. P (Supplemental Petition) (internal quotation marks omitted).)

On January 25, 2018, Elysium submitted a comment to the Supplemental Petition, informing the FDA that it removed toluene from its new version of Basis. (Rhonemus Decl. ¶ 77; id. Ex. Q at 1 (Elysium's comment to Supplemental Petition).) Elysium explained, "Although [it] believes that the ICH Guidelines establish the safety of toluene at the minimal levels previously found in Basis, Elysium elected to eliminate the presence of toluene from Basis as part of its continuing efforts to ensure superior product quality." (Id. )

On September 27, 2018, the Court denied in part CMDX's motion to dismiss and converted the remainder of the motion – the argument that CMDX was immune from liability under the Noerr - Pennington doctrine – to a motion for summary judgment, since that particular issue called upon the Court to consider evidence outside the pleadings. (See Order on Mot, to Dismiss, dated Sept. 27, 2018, Dkt. No. 44.)

That issue is presently before the Court.

II. Discussion

As the Court noted in its earlier Order, the sole issue to be considered is whether the filing of the Citizen Petition is "objectively baseless" and, thus, amenable to Noerr - Pennington 's "sham" exception, thereby disqualifying it from the doctrine's immunity. Elysium argues that summary judgment is not appropriate, because CMDX has not established that there is no genuine issue of material fact as to whether the Citizen Petition was objectively baseless.

The familiar summary judgment standard applies.

Summary judgment is available only in the absence of a "genuine issue of material fact" and where the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c) ; Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The moving party – here, CMDX – has the initial burden of demonstrating the absence of disputed issues of material fact. Celotex v. Catrett , 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). A dispute concerning a material fact is genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Aldrich v. Randolph Cent. Sch. Dist. , 963 F.2d 520, 523 (2d Cir. 1992) (quoting Anderson , 477 U.S. at 248, 106 S.Ct. 2505 ). A genuine issue for trial exists if, based on the record as a whole, a reasonable jury could find in favor of the non-movant. See Anderson , 477 U.S. at 248, 106 S.Ct. 2505.

Elysium, as the party against whom summary judgment is sought, is entitled to all reasonable inferences, and the Court must view the evidence in the light most favorable to it. Anderson , 477 U.S. at 255, 106 S.Ct. 2505. Elysium, however, must go beyond the pleadings and "do more than simply show that...