Opinion ID: 2973615
Heading Depth: 5
Heading Rank: 1

Heading: Validity of the Business Relationship

Text: Appellants first argue that no valid business relationship existed because FDA rules and Tennessee Regulations rendered illegal any business relationship between Appellees and Scott. Appellants’ arguments regarding the invalidity of the business relationship fall short. As the district court discussed, some question remains as to the nature of Appellees’ relationship with Scott (e.g., whether Scott was to be a fact witness, an expert witness, or merely a consulting expert). The FDA cleared Scott to work in some capacity with Appellees; he obtained three approvals from his supervisors. Scott did not obtain approval to testify as an “expert witness,” although FDA regulations permit such approval in rare cases. Appellants argue that any business relationship must have been illegal because Scott could not legally testify as a fact witness or as an expert witness. First, Appellants point to Tennessee Supreme Court Rule 8, Ethical Consideration 7-28, for the proposition that “[a] lawyer should not pay or agree to pay a non-expert witness an amount in excess of reimbursement for expenses and financial loss incident to being a witness.” Appellants claim this renders any fact-witness contract void. But Appellees refer to Scott only as an “expert” witness and consultant. - 10 - Nos. 05-5219; 05-5220 Matthews, et al. v. Storgion, et al. Appellants then point to a federal regulation they contend prohibits Scott’s involvement as an expert witness. They cite to 21 CFR § 20.1(a), which forbids FDA employees, “except as authorized by the Commissioner,” from providing “any testimony . . . with respect to any information acquired in the discharge of [their] official duties.” As the district court pointed out, however, Scott obtained three separate authorizations for his work with Appellees—two for consulting work and one for testimony as a “witness of fact.” Although labeling his role as “witness of fact,” Scott delineated the bounds of his testimony in his request for approval: “to provide factual data about a device type (e.g. how it operates, what it is designed to do)” where the “litigants include patients, doctors and a hospital.” Scott’s departmental “Integrity Officer” approved the request after noting, “Federal Law only prohibits [this type of testimony] in matters before the federal government (18 U.S.C. 203 and 205). Since the government is not involved I see no impediment to your participation . . . .” Thus it appears that Scott obtained specific FDA authorization for his intended testimony, and it is not clear that a court’s or party’s characterization of Scott as an “expert witness” would control the FDA’s internal approval procedures.1 Even assuming, however, Scott’s inability to testify as planned, Appellants have not demonstrated—in fact, do not even argue—Scott’s consulting arrangement with the Appellees to be illegal or invalid. 1 We note that the FDA regulation cited by Appellees prohibits, absent permission, testimony “pertaining to any function of the Food and Drug Administration or with respect to any information acquired in the discharge of his official duties.” Thus the testimony that Scott could have provided under a valid business relationship would be limited to (1) the specific testimony for which he had FDA permission, or (2) other testimony pertaining neither to FDA functions nor information acquired as a result of Scott’s official duties. - 11 - Nos. 05-5219; 05-5220 Matthews, et al. v. Storgion, et al.