Hi-Tech Pharm. Inc. v. Dynamic Sports Nutrition, LLC

• Decision Date: 28 May 2021
• Docket Number: Case No. 1:16-cv-949-MLB
• Court: U.S. District Court — Northern District of Georgia
• Parties: Hi-Tech Pharmaceuticals Inc., Plaintiff, v. Dynamic Sports Nutrition, LLC, et al., Defendants.

Hi-Tech Pharmaceuticals Inc., Plaintiff, v. Dynamic Sports Nutrition, LLC, et al., Defendants.

Case No. 1:16-cv-949-MLB

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION

May 28, 2021

OPINION & ORDER

At pretrial hearings, the Court notified the parties of its decision to deny Plaintiff's motion to exclude expert testimony from Anthony Fontana (Dkt. 236), grant in small part Plaintiff's motion to exclude testimony from Craig Lindsley (Dkt. 238), and grant Defendants' motion to exclude testimony from Linda Gilbert (Dkt. 213). This order supplements the Court's prior conclusions.

I. Background

Plaintiff Hi-Tech Pharmaceuticals Inc. manufactures and sells dietary supplement products, including DIANABOL® and a number of products designed for muscle and body building, hormone boosters, and weight loss aids. (Dkt. 163-2 at 2-3.) On February 5, 2008, the United States Patent and Trademark Office ("PTO") issued a registration for DIANABOL® as a trademark (Registration No. 3,378,354) for use in the pharmaceutical class of trademarks (Class 5) in connection with certain "dietary supplements, excluding anabolic steroids." (Dkt. 64-1.)

For more than a decade Defendant Dynamic Sports Nutrition, LLC, ("DSN") has sold and marketed dietary supplement products, including D-Anabol 25. (Dkt. 160-1 ¶ 22.) In March 2011, DSN applied to the PTO to register D-Anabol 25 as a trademark for dietary supplements. (Dkt. 62 ¶ 21.) On June 28, 2011, the PTO issued an office action refusing the registration because (1) there was a likelihood of confusion with the DIANABOL® trademark; (2) D-Anabol 25 was merely descriptive of a feature of the product; and in the alternative, (3) the product was deceptively misdescriptive. (Dkt. 62-2 at 2-5.)

On February 5, 2014, Plaintiff filed an affidavit with the PTO certifying that (1) the goods associated with DIANABOL® have been in continuous use for five consecutive years and are still in use in commerce; (2) no final decision exists that is adverse to the owner's claim ofownership of DIANABOL® for such goods, or to the owner's right to register the same or to keep the same on the register; and (3) there is no proceeding involving the trademark rights pending in the PTO or in a court. (Dkt. 54-17.) The PTO found Plaintiff's affidavit met the requirements of the Trademark Act, 15 U.S.C. §§ 1058 and 1065, and the DIANABOL® mark was thus incontestable. (Dkt. 54-18.)

Plaintiff then sued Defendant DSN and its owner, Brian Clapp. (Dkt. 62.) The Complaint includes claims for trademark infringement (Counts I & II); false designation of origin and unfair competition (Counts III & IV); false advertising (Count V); violation of the Georgia Deceptive Trade Practices Act (Count VI); common law unfair competition (Count VII); and violations of the Georgia Racketeer Influenced and Corrupt Organizations Act ("RICO") (Counts VIII through X). Defendants assert several defenses, including that DIANABOL® is generic, that the DIANABOL® trademark was obtained by fraud, and that Plaintiff has unclean hands. (Dkt. 67.) As the parties prepared for trial, they filed a series of motions to preclude various experts from testifying. (Dkts. 213; 236; 238.)

II. Legal Standard

Trial courts serve a critical gate-keeping function for the admissibility of expert testimony. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589 (1993). Expert testimony can be particularly persuasive, and as such, the role of the trial court is to keep speculative and unreliable testimony from reaching the jury. Id. at 595; see McCorvey v. Baxter Healthcare Corp., 298 F.3d 1253, 1256 (11th Cir. 2002).

Federal Rule of Evidence 702 allows a qualified expert to give opinion testimony when it is necessary to help the trier of fact understand the issues, the opinion is based on sufficient facts or data, the expert produced it using reliable principles and methods, and those principles and methods were reliably applied to the facts of the case. Fed. R. Evid. 702. The Eleventh Circuit employs a "rigorous" three-part inquiry to determine whether an expert's testimony meets these admissibility criteria. City of Tuscaloosa v. Harcros Chems., Inc., 158 F.3d 548, 562 (11th Cir. 1998). Expert testimony is admissible when

(1) the expert is qualified to testify competently regarding the matters he intends to address; (2) the methodology by which the expert reaches his conclusions is sufficiently reliable as determined by the sort of inquiry mandated in Daubert; and(3) the testimony assists the trier of fact, through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue.

Id. (footnote omitted). Thus, the admissibility of an expert's opinion turns on three things: qualifications, reliability, and helpfulness. See United States v. Frazier, 387 F.3d 1244, 1260-62 (11th Cir. 2004).

While the trial court's role is critical, it "is not intended to supplant the adversary system or the role of the jury." Allison v. McGhan Med. Corp., 184 F.3d 1300, 1311 (11th Cir. 1999). When the accuracy of evidence is the issue—as opposed to its admissibility—the trial court should allow the judicial process to resolve the matter. Daubert, 509 U.S. at 596 ("Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.").

III. Discussion

A. Plaintiff's Motion to Exclude Expert Testimony From Dr. Anthony Fontana

Plaintiff retained Banned Substances Control Group ("BSCG") to test DIANABOL&reg. BSCG is a wholly owned subsidiary of Anti-Doping Sciences Institute. (Dkt. 236-6 at 1.) Anti-Doping Sciences Institute contracted with Truesdail Laboratories Inc. ("Truesdail"), which testsnutritional supplement products for banned substances, to conduct the testing. (Id.) Dr. Fontana is the Technical Director and Chief Science Officer of Truesdail. (Id.) Dr. Fontana issued an expert report opining, among other things, that DIANABOL® contains anabolic steroids, androstenedione, dihydrotestosterone ("DHT"), and dehydroepiandrosterone ("DHEA"). (Dkt. 236-6.) Defendants claim this evidence shows Plaintiff knowingly and intentionally "spiked" DIANABOL® with steroids and that this evidence is relevant to show Plaintiff's DIANABOL® mark was obtained through fraudulent filings and that Plaintiff has unclean hands. (Dkts. 160 at 15-19; 215 at 7, 9, 17.) More specifically, they say the evidence will show that "Hi-Tech and Wheat have engaged in an on-going, twenty-year scheme of USPTO-related fraud by obtaining marks similar or identical in name to common, illegal muscle-building steroids and then spiking those supposedly legal products with banned anabolic steroids[, that] include[] DIANABOL&reg." (Dkt. 215 at 8.)

Plaintiff moves to exclude his testimony. (Dkt. 236.)

1. Dr. Fontana's Background

Dr. Fontana has served as the Technical Director and Chief Science Officer of Truesdail since 2014. (Dkts. 236-6 at 10; 236-4 at 18:8-12.) In that role, he "[o]versees all day-to-day laboratory activities; research and procurement of instrumentation, oversight of senior management, specialized areas of testing, proposal and bid preparation, and develops standard operating procedures"; "[p]rovides senior program and project management, manpower planning, obtains outside certifications, and interacts with regulator agencies"; and "[r]eviews technical data packages and reports." (Dkt. 236-6 at 10.)

Dr. Fontana received his Bachelor of Science in Biochemistry from the University of California, Riverside and his Ph.D in Agricultural and Environmental Chemistry from the University of California, Davis. (Id.) After completing his Ph.D, Dr. Fontana was a senior scientist at Thermalytics, Inc., where he was a Principal Investigator for the Department of Energy, Phase I, Small Business Innovation Research Project. (Id.) He later became a Senior Research Scientist at Decagon Devices, Inc., in a food and pharmaceutical analysis lab, where he conducted research and collaborated with researchers in new technologydevelopment. (Dkts. 236-6 at 10; 236-4 at 14:16-15:3.) Before joining Truesdail, Dr. Fontana was the Technical Director of Chemistry at Silliker, Inc., a food testing, food analysis, and food safety lab specialized in nutritional labeling, allergen testing, and prohibited drug testing. (Dkts. 236-6 at 10; 236-4 at 14:5-14, 15:14-19.) In that position, he provided scientific, application, and technical support to clients, interpreted laboratory data, and provided consulting. (Dkt. 236-4 at 15:14-19.) Dr. Fontana has over 40 published papers and presentations on environmental and nutritional analysis and analytical methods development. (Dkt. 236-6 at 10.)

2. Truesdail's Testing Procedures

Truesdail is an International Standardization Organization accredited testing laboratory (ISO/IEC-170251 and 170652) and Racing Medication & Testing Consortium accredited testing laboratory. (Dkt. 236-6 at 1-2.) Included in Truesdail's ISO/IEC 17025 Scope of Accreditation is instrumental screening and confirmation of chemical identity of Nutritional Supplements. (Id. at 2.) Truesdail uses international, agreed-upon guidelines for identifying compounds by chromatography and mass spectrometry. (Id.) In his role as TechnicalDirector, Dr. Fontana develops the standard operating procedures ("SOPs") for testing, which all laboratory technicians must follow. (Id. at 10.) The SOPs contain a list of set protocols, such as the requisite temperature and gas flow for the testing instruments. (Dkt. 236-4 at 48:01-49:13.) The SOPs do not require (or permit) the lab technicians to exercise any judgment or discretion. (Id.)

Dr. Fontana's report and deposition testimony explains Truesdail's testing process from start to finish in great detail. When Truesdail receives a sample or batch, a laboratory technician inspects the sample and...