Chemistry Expert Witness’ Testimony Admitted Because He Conducted An Independent Analysis of FDA Regulations
Posted on January 15, 2025 by Expert Witness Profiler
Plaintiff Multiple Energy Technologies, LLC (“MET”) accused Under Armour of false advertising in relation to certain products that contain bioceramic powder. MET contended that Under Armour inaccurately claimed that the Federal Food and Drug Administration had determined that those products enhanced recovery.
Under Armour sells activewear and sleepwear products directly to consumers. This includes the sale of products containing a competing bioceramic product known as celliant, which is manufactured by Hologenix, LLC (“Hologenix”). Under Armour advertises these products separately from their other product offers and as helping to promote recovery, especially for athletes.
Plaintiff MET brought four claims against Defendant Under Armour, Inc.: violation of the Lanham Act, violation of the Sherman Act, misappropriation of trade secrets; breach of non-disclosure agreement; tortious interference with contract; tortious interference with prospective business expectancies; unjust enrichment; unfair competition; conversion; a claim for an accounting; and a claim for injunctive relief.
Alberto Gutierrez
MET’s Lanham Act claim is based principally on certain advertisements for Under Armour products that reference the FDA’s alleged treatment of celliant. The FDA language used in those advertisements originated with Hologenix, the manufacturer of celliant. Hologenix based those statements on its interpretation of the FDA’s June 8, 2017 response to Hologenix’s request for information regarding the FDA’s classification of celliant (the “FDA Letter”).
MET retained Dr. Alberto Gutierrez to “opine about the classification process by the FDA, the intent of the June 8, 2017 letter from the FDA to Hologenix and the statements made by Under Armour about celliant and the FDA.” Under Armour filed a motion to exclude Gutierrez’s opinions.
Chemistry Expert Witness
Alberto Gutierrez worked at the FDA for 25 years in various departments. At the FDA, Gutierrez was personally involved with the process by which the FDA responds to requests for information pursuant to section 513(g) and in making determinations of what is a medical device that would be regulated by the FDA. Gutierrez is now a consultant who helps device companies navigate the FDA regulatory requirements and provides strategic advice on regulatory issues and helps companies with submissions to the FDA.
Discussion by the Court
I. Qualification
First, Under Armour argued that ” Gutierrez is not qualified as an expert to opine on advertising or marketing issues, including the intent of the advertisements in question or the impact of those advertisements on consumers” because his background is in chemistry, he has no experience in advertising or consumer perception, and has never studied nor done any consulting work on the impact of advertisements on consumers. According to Under Armour, Gutierrez’s opinion is “purely speculative” with regard to whether Under Armour adopted a “campaign of deception.” Under Armour also argued that even if Gutierrez is not being offered as a consumer impact expert, his “campaign of deception” opinion is speculative and unreliable and shouldn’t be admitted.
The Court concluded that Gutierrez is qualified to offer an opinion on Under Armour’s statements about celliant and the FDA. Gutierrez is not being offered as an expert on the intent or consumer impact of advertisements—instead, Gutierrez is being offered “to opine about the classification process by the FDA, the intent of the June 8, 2017 letter from the FDA to Hologenix and the statements made by Under Armour about celliant and the FDA.”
The Court noted that Gutierrez worked at the FDA for 25 years in various positions, ultimately holding a director position. After his career in the FDA, Gutierrez joined a consulting group that helps companies navigate FDA regulatory requirements.
Independent Analysis
Second, Under Armour argued that even if Gutierrez is not qualified as an expert in the field of consumer perception, his report should be excluded because he did not perform any independent analysis. Under Armour argued that Gutierrez “took counsel’s word for it” that Under Armour engaged in a campaign of deception and did not review data related to consumers visiting websites containing the advertisements at issue, how long each website was active, or how many products with celliant Under Armour sold in a given year. Under Armour further argued that the “campaign of deception” opinion is not based on independent analysis.
However, the Court found that Guttierez did perform sufficient independent analysis. Under Armour objects to Gutuerrez’s statement that Under Armour engaged in a “campaign of deception.” Gutierrez concluded in his report that Under Armour’s statements about celliant were false in light of FDA regulations and practices.
He further opined that the statements in the documents that he reviewed were “false, deceptive and misleading” because the FDA had not determined that celliant products led to faster recovery, only that the health-related claims made by Hologenix would qualify celliant products as medical devices.
Moreover, Under Armour, by claiming that Gutierrez is not qualified as an expert on the intent of advertisements, attacked Gutierrez’s conclusions by stating that he “took counsel’s word for it” about Under Armour’s intent to deceive. But the Court held that Gutierrez did not purport to opine on Under Armour’s intent in the advertisements—instead, he concluded based on his knowledge and expertise that the statements were false, not that Under Armour intended to deceive consumers.
Documents and Conclusions
Third, Under Armour argued that the documents Gutierrez relied on do not support his conclusions. Additionally, Under Armour objects to the use of the phrase “FDA approval” in Gutierrez’s report and argues that his report should be excluded because he reviewed no documents with that specific claim.
However, the Court found that the documents Gutierrez reviewed support his opinions, and any argument that they do not goes to the weight, and not the admissibility, of his opinion.
Gutierrez’s report states that he reviewed Under Armour product pages from its website and from Amazon, and he also reviewed a letter from the FDA to Holegenix. Additionally, Gutierrez reviewed an article stating that celliant fabric had received “FDA approval” as a medical device.
Opinions about FDA Regulations
Fourth, Under Armour argued that Gutierrez’s report contains impermissible legal opinions on the applicability of FDA regulations to the case.
The Court found that Gutierrez’s opinions about the FDA’s regulations and procedures are relevant and are not legal opinions. Courts frequently admit the type of expert testimony that Gutierrez offers, and the Court sees no issues with admitting his opinions here.
The Court held that Gutierrez may testify so long as he does not give an opinion as to what is required under the law.
Held
The Court denied Under Armour’s motion to exclude Dr. Alberto Gutierrez’s expert report.
Key Takeaway:
Concerns about the documents an expert reviewed go to the weight of the evidence, not the admissibility, and are appropriately addressed in cross-examination. An expert has “good grounds” for relying on documents containing statements regarding the FDA because they are the type of documents an expert reviewing whether statements are consistent with FDA regulations would rely upon.
Please refer to the blog previously published about this case:
Marketing Expert Witness’ Testimony on Consumer Perceptions Excluded Because His Survey is Flawed
Case Details:
| Case Caption: | Multiple Energy Technologies, LLC V. Under Armour, Inc |
| Docket Number: | 2:20cv664 |
| Court: | United States District Court, Pennsylvania Western |
| Order Date: | January 13, 2025 |
