We take a look at the admissibility of FDA 510(k) application in a medical device product liability case. 
Case: McClellan v. I-Flow, Inc., 2010 WL 3954092 (Dist. Ct. 2010) (U.S. District Court of Oregon)
Plaintiff filed a Motion to Admit Newly Discovered Evidence to introduce documents received from the FDA in response to a FOIA request for the regulatory file for defendant’s pain pump device (the PainBuster). The specific memo at issue was regarding defendant I-Flow’s 510(k) application seeking FDA clearance to market the device.
Plaintiff contended that the FDA did not clear specific indications for orthopedic or intra-articular uses of the PainBuster. The defendants argued that the device was cleared for general surgeries and therefore that encompassed orthopedic or intra-articular uses. The memo at issue discussed that the “510(k) was originally submitted with expanded indications for use, i.e., for continuous infusion of a local anesthetic directly into the intra-articular site for postoperative pain management, however, there was no accompanying data to demonstrate that this device may be used safely and effectively with this use.” The memo further stated that further information was required regarding the safety for the above use. The indications were modified and “limited to general surgery.” The 510(k) application was subsequently approved.
Three important holdings:
- First the court held that the memo was admissible under the public record exception to hearsay.
- Second the court held that the 510K application was relevant because the defendants repeatedly relied on FDA’s clearance to demonstrate it’s safety.
- Finally, the court held that admitting the 510K application was not prejudicial to the defendants.
Admitted As Public Record Exception To Hearsay
The court found that the memo fit within the public record exception to the hearsay rule. Fed. R. Evid. 803(8). The defendants argued that the memo was untrustworthy however, the court determined that the memo was trustworthy as it was prepared pursuant to a lawful review by the FDA, relied on by the FDA, and provided by the FDA in response to the FOIA request. Id. at 3. Additionally, while the memo contained a recommendation or opinion, it was still admissible as a public record. “Given that the Memo constitutes the ‘Substantial Equivalence Decision-Making Documentation” supporting the FDA’s Clearance Letter, the Memo’s description of agency activities and factual findings form the factual basis of the FDA’s final decision.” Id. The defendants’ argument that the memo was irrelevant also fell on deaf ears.
Memo Was Relevant
The defendants argued that the 510(k) process was misinterpreted by the plaintiffs and that “the absence of a predicate device establishing the safety and efficacy of a medical device is separate and distinct from the presence of safety and efficacy concerns about a medical device.” Id. at 4. The Defendant argued that the memo reflected the former. The court determined that the memo was relevant because the defendants repeatedly relied on the FDA’s clearance of the device to demonstrate its safety. The court found that defendants arguments throughout trial implicated issues explicitly discussed in the memo, namely “the scope of FDA clearance for the PainBuster and the need for additional information to support an indication for orthopedic or intra-articular uses.” Id. at 6. Finally, the court held that the memo was not prejudicial to defendants.
Not Prejudicial
The court determined that the memo was not prejudicial as it most of the information in the documents originated from defendants or was communicated to them. Additionally, the memo was in line with plaintiffs’ claims as they existed and did not implicate or invite any new claims or arguments. “The fact that admission of the Memo may, depending on how it is viewed, prejudice the viability or credibility of I-Flow’s position or witnesses is not the type of prejudice that warrants exclusion of the evidence.” Id. at 6.