FDA Expert Opinion Irrelevant To Breach of Warranty Discussion In Medical Device Class Action

    Medical Device Expert

    Court: United States District Court for the Eastern District of Pennsylvania
    Jurisdiction: Federal
    Case Name: Ctr. City Periodontists, P.C. v. Dentsply Int’l, Inc.
    Citation: 321 F.R.D. 193


    The plaintiffs brought this action against the defendants for breach of express warranty claims for a dental and periodontal tool they manufactured, marketed, and sold throughout the United States. The plaintiffs alleged that the device was unfit for its intended use because it deposited biofilm on the water lines of the device even when used as directed. This defect exposed patients to potentially hazardous levels of bacteria in excess of safe water standards.

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    The plaintiffs brought this action for class certification and appointment of class counsel pursuant to Rule 23 of the Federal Code of Civil Procedure. The defendants moved to preclude the testimony of the plaintiff’s medical device expert witness, a former administrator at the Food and Drug Administration (FDA) who had opined on the federal regulations pertaining to the defendant’s device.

    The Medical Device Expert Witness

    The plaintiff’s medical device expert witness was a former FDA administrator. He held a bachelor’s degree in microbiology and a master’s in physiology with an emphasis on biomedical engineering. He also had more than 36 years of experience with FDA regulatory compliance practices and issues related to biomedical devices.


    The court noted that there are three requirements for admissibility of expert testimony under Daubert: qualification, reliability and fit. Citing Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 321 (3d Cir. 2003)(quoting Schneider v. Fried, 320 F.3d 396, 405 (3d Cir. 2003)). The witness should possess specific expertise and his opinion, and the opinion should be based on scientific reasoning and methodology. The opinion must also be relevant to the case and helpful for the trier of fact.

    The court then discussed the relevance of the expert’s testimony to the issues at hand. The parties agreed that the relevant factual questions were whether the directions for use (DFUs) contained an express warranty of safety and suitability and whether the defendant breached that warranty.

    In light of this, the court noted that the medical device expert’s opinion on the device’s regulatory issues, implications, and consequences was irrelevant to the factual matter of the case because the question of express warranty would depend on the language of the DFUs and whether the defendant’s actions constituted a breach of it. The expert’s testimony on regulatory implications of the device was considered irrelevant to determine the same. He also did not have any knowledge of provisions relating to class certification and thus his opinion could not be used to ascertain the same.

    The court rejected the plaintiff’s representation that the medical device expert’s testimony “helps to show they can satisfy the commonality, typicality, and predominance requirements under Rule 23, because those factors focus on defendant’s conduct, and the expert’s testimony will establish that Dentsply’s representations . . . were both uniform throughout the class period and incorrect”. The court noted that the plaintiffs could not cite any case in which a court had admitted the testimony of a regulatory expert in an express warranty issue.


    The court held that the expert’s testimony was not relevant to the case and did not help classify the plaintiffs as a class. Thus, the plaintiffs’ claim for class certification was denied.