--- title: "FDA Expert Witness’ Testimony Excluded Because He Did Not Test His Theories" meta: "og:description": "FDA expert witness had not done any work in this case to rule in or rule out any of the possible explanations" "og:title": "FDA Expert Witness’ Testimony Excluded Because He Did Not Test His Theories" author: "Expert Witness Profiler" description: "FDA expert witness had not done any work in this case to rule in or rule out any of the possible explanations" --- # FDA Expert Witness’ Testimony Excluded Because He Did Not Test His Theories Posted on August 6, 2024 by Expert Witness Profiler The Plaintiffs — Carmelo Leon and Wanda Leon — brought this action against the Defendants — United Industries Corporation (“UIC”), Spectrum Brands, Inc. (“SBI”), Cutter, and Home Depot U.S.A., Inc. (“Home Depot”) — after Carmelo Leon sustained burn injuries during an incident involving a mosquito-repelling candle manufactured and sold by the Defendants. The Defendants initially moved to exclude the testimony of the Plaintiffs’ expert, [Courtland Imel](https://expertwitnessprofiler.com/expert-witness/Robert-Imel/1559991). In this case, the Defendants challenged Imel’s testimony on the second factor under [Rule 702](https://www.law.cornell.edu/rules/fre/rule_702#:~:text=Rule%20702%20sets%20forth%20the,is%20a%20relatively%20narrow%20inquiry.): whether the proposed expert opinion is based upon reliable data and methodology. ## **FDA Expert Witness** [Courtland Imel](https://expertwitnessprofiler.com/expert-witness/Robert-Imel/1559991) is a senior consultant with experience in product development, quality, validation, training, regulatory compliance, and regulatory submissions (IND, NDA, ANDA, 510K, PMA, and DMF) for pharmaceutical, medical device, nutraceutical, cosmetic, and vet products. He has 36 years of experience in the FDA regulated industry. Imel started Ceutical Labs to provide the needed infrastructure that many companies lack, but require to manage projects and daily activities. He has a Bachelor of Science degree in Chemistry from Baylor University. [Want to know more about the challenges Courtland Imel has faced? Get the full details with our Challenge Study report.](https://app.expertwitnessprofiler.com/login?eId=1559991) ## **Discussion by the Court** Imel’s expert report contains four general “possible causes for candle fires.” However, the report did not contain an opinion as to the cause of the candle fire in this case. In fact, Imel testified that he can test his hypothesis in his lab but had not yet. In Imel’s deposition, he confirmed that he “had not done any work in this case to rule in or rule out any of those possible explanations.” Therefore, the Court held that Imel’s opinions are not based on reliable data and methodology. The Plaintiffs argued that Imel “can still test his theories before the time of trial and render an opinion.” For a Court to determine whether an expert opinion is admissible, that “opinion requires some explanation as to how the expert came to his conclusion and what methodologies or evidence substantiate that conclusion.” Therefore, it is at this stage of the litigation that the Court requires information about the tests and data underlying Imel’s testimony. The time for discovery in this case has passed, and Imel cannot now go back and conduct the testing to support his hypotheses. ## **Held** The Court granted the Defendants’ motion to exclude Courtland Imel’s expert testimony. ## **Key Takeaway:** Imel was yet to test his hypothesis in this case and he had not done any work in this case to rule in or rule out any of the possible explanations. While testing is not an absolute prerequisite for admitting an expert opinion, it is usually critical to show that an expert “adhered to the same standards of intellectual rigor that are demanded in their professional work.” The Court held that Imel’s expert report did not contain an opinion as to the cause of the candle fire in this case. ## **Case Details:** --- ## **You Might Also Like** ![Human Resources Expert Allowed to Opine on Termination](https://ewp-blog.expertwitnessprofiler.org/wp-content/uploads/2026/04/blog-pic-640X480-2026-04-22T200052.311.jpg) [**Human Resources Expert Allowed to Opine on Termination**](https://expertwitnessprofiler.com/fda-expert-witness-testimony-excluded-because-he-did-not-test-his-theories/human-resources-expert-allowed-to-opine-on-termination)![Neuropsychology Expert Not Allowed to Opine on Cognitive Decline](https://ewp-blog.expertwitnessprofiler.org/wp-content/uploads/2026/04/blog-pic-640X480-2026-04-22T144728.528.jpg) [**Neuropsychology Expert Not Allowed to Opine on Cognitive Decline **](https://expertwitnessprofiler.com/fda-expert-witness-testimony-excluded-because-he-did-not-test-his-theories/neuropsychology-expert-not-allowed-to-opine-on-cognitive-decline)![Human Factors Expert Not Allowed to Opine on the Tile](https://ewp-blog.expertwitnessprofiler.org/wp-content/uploads/2026/04/blog-pic-640X480-2026-04-21T191749.960.jpg) [**Human Factors Expert Not Allowed to Opine on the Tile**](https://expertwitnessprofiler.com/fda-expert-witness-testimony-excluded-because-he-did-not-test-his-theories/human-factors-expert-not-allowed-to-opine-on-the-tile)![Insurance Expert Not Allowed to Opine on Legal Duties](https://ewp-blog.expertwitnessprofiler.org/wp-content/uploads/2026/04/blog-pic-640X480-2026-04-21T155751.487.jpg) [**Insurance Expert Not Allowed to Opine on Legal Duties**](https://expertwitnessprofiler.com/fda-expert-witness-testimony-excluded-because-he-did-not-test-his-theories/insurance-expert-not-allowed-to-opine-on-legal-duties)![Law And Legal Expert Not Allowed to Opine on Contract Formation](https://ewp-blog.expertwitnessprofiler.org/wp-content/uploads/2026/04/blog-pic-640X480-2026-04-20T213123.718.jpg) [**Law And Legal Expert Not Allowed to Opine on Contract Formation**](https://expertwitnessprofiler.com/fda-expert-witness-testimony-excluded-because-he-did-not-test-his-theories/law-and-legal-expert-not-allowed-to-opine-on-contract-formation)