Macuhealth, LP v. Vision Elements, Inc.

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MACUHEALTH, LP, Plaintiff, v. VISION ELEMENTS, INC., Defendant.

No. 8:22-cv-199-VMC-JSS

United States District Court, M.D. Florida, Tampa Division

June 7, 2023

ORDER

VIRGINIA M. HERNANDEZ COVINGTON, UNITED STATES DISTRICT JUDGE

This matter is before the Court on consideration of Plaintiff MacuHealth, LP's Motion for Summary Judgment (Doc. # 63) filed on February 13, 2023, Defendant Vision Elements Inc.'s Motion for Summary Judgment (Doc. # 66), filed on February 13, 2023, MacuHealth's Daubert Motion to exclude the testimony of one of Vision Elements' experts (Doc. # filed on February 13, 2023, and Vision Elements' Motion to Exclude one of MacuHealth's expert's supplemental report (Doc. # 77), filed on February 16, 2023. Both parties responded to the summary judgment motions on March 13, (Doc. ## 81, 83). Vision Elements responded to MacuHealth's Daubert Motion and MacuHealth responded to Vision Elements' Motion to Exclude, also on March 13, 2023. (Doc. ## 82, Both parties replied to the summary judgment motions. (Doc ## 86, 87).

For the reasons that follow, MacuHealth's Daubert Motion is denied, Vision Elements' Motion to Exclude is denied, Vision Elements' Motion for Summary Judgment is denied, and MacuHealth's Motion for Summary Judgment is granted in part and denied in part.

I. Background

A. The Parties

MacuHealth sells a nutritional supplement called “MacuHealth” that is intended to maintain or improve eye health. (Doc. # 78-6 at 24:13-22). Below is an image of the MacuHealth bottle:

(Image omitted)

(Doc. # 63-3 at 50). Each capsule of MacuHealth's product contains three active ingredients: lutein, zeaxanthin, and mesozeaxanthin (“LMZ carotenoids”). (Doc. # 78-6 at 24:13 22).

Vision Elements also sells a nutritional supplement, called “Early Defense,” intended to maintain or improve eye health. (Doc. # 78-1 at 33:11-19). Early Defense is available throughout the United States via its website and has been sold and shipped to customers in multiple states in interstate commerce. (Id. at 46:11-21). Vision Elements' only employees are its owners, Matthew Hinton and Jennifer Hinton. (Id. at 30:14-17). Approximately 1 percent of Early Defense product sales are direct to consumers and 99 percent are to eyecare physicians. (Doc. # 66-2 at ¶ 7). Vision Elements states that its supplement has the same LMZ carotenoids, in the same amount, as MacuHealth's supplement does. (Id. At 24:16-25). According to Mr. Hinton, Early Defense competes with MacuHealth:

Q. Okay. So who are your competitors who sell product that includes the carotenoids lutein, zeaxanthin, and mesozeaxanthin?

A. I would say almost any product on the market would contain some amount of mesozeaxanthin, even if it's not disclosed. Every product marketed for eyes would contain lutein, likely zeaxanthin. And I'm aware of just a couple that would have mesozeaxanthin claimed on the label. Q. And which are those?

A. MacuHealth comes to mind first.

(Id. at 43:13-44:5).

The LMZ carotenoids used in MacuHealth and Early Defense are extracted and derived from marigold flower petals using solvents. (Doc. # 63-5 at 126:1-19). It is industry standard to use as solvents hexane or methanol to extract and derive the LMZ carotenoids. (Id. at 132:2-5; Doc. # 78-6 at 18: 22 19:3). The solvents are largely removed from the LMZ carotenoids during the production process, but residual amounts remain in the final product. (Doc. # 63-4 at 43).

B. Vision Elements' Advertisements

When this suit commenced, Vision Elements' advertisements promoting Early Defense stated that it was (1) made without the use of Class 2 solvents, such as hexane, methanol, and acetone and (2) no residual solvents are present in Early Defense. (Doc. # 66-2 at ¶ 10). Specifically, Vision Elements claimed that Early Defense contained “Clean label ingredients: Solvent-free carotenoids derived from non-GMO marigold flowers through an eco-friendly super critical CO2 extraction process - No hexane, methanol, or acetone.” (Doc. # 63-2 at 11). The Early Defense bottle states that Early Defense “contains none of the following: . . . Class 2 solvents - hexane, methanol, acetone[.]” (Id. At 15) (emphasis in original). The Food and Drug Administration states that Class 2 solvents “should be limited in pharmaceutical products because of their inherent toxicity.” (Doc. # 63-4 at 15).

Mr. Hinton also testified that Vision Elements conveyed that Early Defense did not use, and was free from, Class 2 solvents to customers at trade shows, in personal product pitches, and in emails to potential customers. (Doc. # 78-1 at 198:21-199:2; Doc. # 78-4 at 292-93). Vision Elements claims that it has ceased publishing these claims on its website or brochures in order to avoid further litigation. (Doc. # 66-2 at ¶ 16).

Vision Elements also created the following advertisement:

(Image omitted)

(Image omitted)

(Doc. # 78-3 at 299). Mr. Hinton acknowledges that he created the Competitor A bottle using a photo of the MacuHealth bottle. (Doc. # 78-2 at 139:6-21; 142:19-23). Frederic Jouhet, MacuHealth's CEO, testified that consumers would recognize the Competitor A bottle as that of MacuHealth. See (Doc. # 78-5 at 44:22-45:3) (“There is a marketing document that shows a . . . Vision Essence bottle side by side with a MacuHealth bottle that has been blurred slightly, but not enough to not convince the doctors what we're discussing.”).

Additionally, Vision Elements also distributes a promotional document titled “Competitor Solvent Extraction Method” at trade shows. (Doc. # 78-2 at 147:11-148:2; Doc. # 78-4 at 311). It includes a cover page of a patent assigned to Industrial Organica, S.A. de C.V. (“IOSA”), MacuHealth's LMZ carotenoid supplier, and compares IOSA's use of hexane as an extraction solvent to the use of supercritical CO2 extraction techniques. (Doc. # 78-4 at 311). Vision Elements used this document to distinguish its product from MacuHealth, which uses hexane in the extraction process. (Doc. # 78-3 at 148:22-149:10). MacuHealth is the only competitor of Vision Elements that used IOSA as a supplier. (Id. at 150:15-19).

Vision Elements purchases its LMZ carotenoids from a a brokerage company from India called FT. (Doc. # 78-1 at 68:47). Vision Elements does not know the identity of the entity that extracts the LMZ carotenoids used in Early Defense, and Mr. Hinton was not curious about the third-party extraction. (Doc. # 78-3 at 17:1-8; 21:19-23). However, MacuHealth determined that FT, in turn, purchases the LMZ carotenoids from a third-party manufacturer, Bio-gen. (Doc. # 78-3 at 27:5-8; 32:20-33:6; 35:1-6). Bio-gen stated that it extracts LMZ carotenoids from marigolds using hexane as a solvent.

(Doc. # 78-8 at 2; Doc. # 63-9 at 82). It also confirmed that it did not use super critical CO2 extraction. (Doc. # 63-9 at 82). Mr. Hinton stated that he was not aware until the start of this litigation that FT did not do its own extraction. (Doc. # 78-3 at 17:1-8; 21:19-23). He also acknowledged that he never asked and FT never told him whether Class 2 solvents were used to extract the LMZ carotenoids it sold. (Doc. # 781 at 83:14-22; 84:10-14; 84:1-9).

The parties dispute whether a supercritical CO2 extraction process is commercially feasible and whether any commercial supplier uses it. Vision Elements relies on the certificates of analysis (“COAs”) it received from FT to demonstrate that the supercritical CO2 extraction method was used on the batches it purchased. (Doc. # 66-2 at 8-9).

MacuHealth's experts, Carlos Torres and Dr. James Stringham, on the other hand, testified that they are not aware of any suppliers who claim to be able to extract LMZ carotenoids without the use of Class 2 solvents. (Doc. # 63-5 at 163:918; Doc. # 63-8 at 95:23-96:1). However, the parties agree that Bio-gen does not offer LMZ carotenoids obtained using the supercritical CO2 extraction process. (Doc. # 78-5 at 160-61).

Vision Elements relies on two pieces of evidence to support its solvent claims: (1) the COAs provided by FT and (2) a Canadian Analytical Laboratories (“CAL”) report on testing conducted on Early Defence, a different product sold in Canada by Mr. Hinton's company, Vision Essence. (Doc. # 78-1 at 109:6-16). Mr. Hinton admitted that all the FT COAs for mesozeaxanthin and two of the four FT COAs for lutein/zeaxanthin are silent as to the presence or absence of residual Class 2 solvents. (Id. At 157:17-158:2; 158:21-3; 159:23-160:3;161:23-162:10;162:17-163:4; 163:11-15). Mr. Hinton ultimately admitted that none of the COAs provide a basis for whether the Class 2 solvents were used. (Id. at 152:18-22). Mr. Hinton further acknowledged that the CAL report is irrelevant to the case, as the testing was not done on the American version of Early Defense at issue. (Id. at 101:13-23). Finally, Mr. Hinton admitted that the CAL report only determined whether the levels of the Class 2 solvents exceeded standard limits, and did not assess whether such solvents were present in any amount, and he acknowledged that the report “does not provide a factual foundation or basis” to claim that no Class 2 solvents were used in the extraction process. (Id. at 185:14-186:1).

C. Testing of MacuHealth and Early Defense

In December 2021 and September 2022, IOSA tested multiple batches of Early Defense for the presence of residual solvents. (Doc. # 63-5 at 47:4-19; Doc. # 63-6 at 119; Doc. # 63-8 at 214). IOSA issued certified reports for the tests both of which reported the presence of hexane, methanol and acetone in the Early Defense capsules. (Doc. # 63-4 at ¶¶ 7172 Doc. # 63-5 at 95:2-11). At MacuHealth's request, two additional independent laboratories, ACS Laboratories and UFAG Laboratorien, tested Early Defense for the presence of...