Law & Legal Expert Witness’ Testimony Excluded Because it Does Not Require Complex Analysis of Certain Documents
Posted on January 6, 2025 by Expert Witness Profiler
Elevation placed two orders for, and Icon delivered two shipments of, iHealth COVID-19 Antigen Rapid Test Kits (“Test Kits”) to Elevation pursuant to those orders. Elevation paid Gypset for the first shipment but refused to pay Icon for the second. In March, Elevation’s counsel sent a letter purporting to reject both the first and second shipment—the first because the Test Kits were delivered 45 days after payment and bore “extremely short expiration dates” and the second because the Test Kits were delivered “without order or authorization” and also bore “extremely short expiration dates.”
Icon filed this instant collection action against Elevation Health. Elevation Health responded by asserting counterclaims against Icon and third-party claims against Gypset, which arranged for the first shipment.
Basically, Elevation intended to proffer expert testimony from purported FDA regulatory expert Evan Parker Phelps, an attorney. Phelps’ expert report indicates that he intends to rely primarily on two documents (1) a December 22, 2021 U.S. Food and Drug Administration Letter of Authorization to iHealth Labs, Inc. (“iHealth”) authorizing the COVID-19 Antigen Rapid Tests (the “December 21, 2021 iHealth Authorization Letter”) and (2) an Authorized Distributor Agreement between iHealth and Icon for COVID-19 Antigen Home Test, effective February 1, 2022 (the “February 1, 2022 Distributor Agreement”).
Icon argued that Phelps’ testimony should be excluded because he is not qualified to offer the opinions in his expert report, his opinions are not based on reliable methodology, and his opinions are impermissible legal conclusions.
Law & Legal Expert Witness
Evan P. Phelps is a seasoned FDA legal practitioner specializing in medical device regulation with additional experience with issues related to U.S. Food and Drug Administration (FDA) regulation of pharmaceutical products, Human Cell and Tissue Products (“HCT/P”), and electronic products, among others.
Discussion by the Court
Based on these documents and Phelps’ experience as a lawyer specializing in FDA regulations, he offers the following opinions: (i) neither Icon nor Gypset was an authorized distributor that could lawfully distribute the Test Kits to Elevation Health prior to February 1, 2022; (ii) neither Icon nor Gypset lawfully could have been in possession of Test Kits prior to February 1, 2022; (iii) communications from Icon and Gypset indicating possession and authority to distribute Test Kits to Elevation Health prior to February 1, 2022 are not consistent with the lawful distribution of Test Kits; and (iv) Elevation Health should not have distributed the Test Kits, which were potentially counterfeit, without confirming their authenticity.
According to Icon, Phelps’ experience as a lawyer specializing in FDA regulations is not sufficiently related to his opinions regarding whether Icon was an authorized distributor of iHealth test kits prior to February 2022 as his opinions are not based on FDA regulations and the documents on which he relied did not support his conclusions. Elevation disagreed and pointed to an FDA regulation that requires iHealth to identify authorized distributors to the FDA as reliable support for his opinion that Icon and Gypset could not lawfully have distributed or possessed iHealth test kits before February 2022.
Legal Conclusions
Icon also argued that Phelps’ testimony should be excluded because each of his opinions offer improper legal conclusions as to whether Icon and Gypset acted “lawfully” or were “legally prohibited from further distributing the tests.” Seemingly conceding that Phelps’ opinions are legal conclusions, Elevation argued that they are permissible because they are not the “ultimate legal conclusions” in the case since there is no cause of action for violating FDA regulations.
But Elevation pointed to no case law that states that an expert may offer legal conclusions as long as they are not the ultimate legal conclusions of the case.
The Court held that Phelps’ proposed opinions are legal conclusions on their face and improperly invaded the province of the jury to apply the law to the facts. Phelps stated that: (i) neither Icon nor Gypset could “lawfully distribute” or “lawfully” posssess iHealth test kits by a certain date; (ii) that Icon and Gypset’s statements “indicating the possession and authority to distribute” prior to that date were thus false; (iii) that the test kits that were distributed were “potentially counterfeit” and as such, Icon and Gypset were “legally prohibited from further distributing the tests without first confirming their authenticity.
Testimony only qualifies as an “expert opinion” if it “concerns matters that the average juror is not capable of understanding on his or her own.” Here Phelps’ determination that Gypset and Icon were not legally authorized to possess iHealth test kits is largely based on the dates of two documents—one authorizing iHealth test kits themselves and the other apparently permitting Icon to distribute those kits. The Court held that Elevation’s argument does not require complex analysis of these documents beyond the ken of the average juror.
Held
The Court granted Icon’s motion to exclude the testimony of Evan Phelps.
Key Takeaway:
To begin with, one of the fundamental requirements of Rule 702 is that the proposed testimony assists the trier of fact to understand the evidence or to determine a fact in issue. Testimony only qualifies as an expert opinion if it concerns matters that the average juror is not capable of understanding on his or her own. Moreover, a district court may commit manifest error by admitting expert testimony where the subject matter of the expert’s testimony is not beyond the ken of the average juror.
Case Details:
| Case Caption: | Icon International, Inc. V. Elevation Health LLC |
| Docket Number: | 1:22cv4304 |
| Court: | United States District Court, New York Southern |
| Order Date: | January 03, 2025 |
