Products Liability Law Daily Wrap Up, EXPERT EVIDENCE—MEDICAL DEVICES—D. Ariz.: FDA expert may opine on 510(k) process but cannot imply Bard’s catheter was found ‘safe’, (Sep 18, 2026)

By Nadine E. Roddy, J.D.

The court ruled that many of the expert’s opinions were permissible but found that others did not meet the requirements of Rule 702.

An FDA-experienced expert witness for the defense in multidistrict litigation involving the safety of implanted port catheters (IPCs) manufactured by C.R. Bard, Inc. would be permitted to opine on some matters, but not others, the federal district court in Arizona has ruled. Specifically, the court ruled the expert—who holds a master’s degree in biomedical engineering—cannot opine (1) on device infection rates or comparative infection rates, (2) on patient or physician preferences, (3) that the FDA approved the defendants’ labeling, or the instructions and warnings it contained, through the 510(k) process, (4) on chemical manufacturers’ reasons for issuing cautionary statements, or (5) on what the FDA perceived or believed regarding the device (In re: Bard Implanted Port Catheter Products Liability Litigation, No. 2:23-md-03081-DGC (D. Ariz. Sept. 8, 2026)).

Implanted port catheters. This multidistrict litigation involves thousands of personal injury cases related to implanted port catheters (IPCs) designed, manufactured, and marketed by several defendant companies (collectively, Bard). The plaintiff patients/consumers (Consumers) filed a motion to exclude the expert opinions of a proposed expert witness (Foreman). An IPC is a medical device, consisting of a port and a catheter, that is surgically implanted under the skin to provide repeated access to a patient’s vascular system without the need for multiple needlesticks into peripheral veins.

At issue in this litigation were multiple versions of Bard IPCs, each of which received premarket clearance from the FDA. Each Consumer had a Bard IPC implanted in their body, which was allegedly defective and which caused serious injury. Further, safer alternative designs and manufacturing processes were allegedly available to Bard at the relevant times. The Consumers asserted “a host of state law claims,” including design and manufacturing defects, failure to warn, breach of warranty, misrepresentation, concealment, and consumer fraud and unfair trade practices.

Foreman held a master’s degree in biomedical engineering, and she had a 22-year career with the FDA as a reviewer and then director for the Office of Device Evaluation (ODE) of the Center for Devices and Radiological Health (CDRH). In this role, she reviewed medical device submissions through various regulatory processes, including the 510(k) process. She left the FDA to join a biologics consulting firm, where she advised clients on “regulatory strategies for medical devices.”

The Consumers moved to exclude several of Foreman’s opinions under Rules 702 and 403.

Rule 702. The court noted that under Rule 702, the proponent of the expert witness must show by a preponderance of the evidence that the witness’s testimony satisfies each of the Rule’s four requirements. The court’s task is not to decide whether the expert is right or wrong, but to ensure that the proposed opinions satisfy the Rule.

Port infection rates. The Consumers challenged Foreman’s opinions that IPCs have “lower infection rates than other catheters,” and “[f]or devices that are externally communicating... the risk of infection differs as compared to that of a device that is contained entirely within the body such as an IPC.” Bard countered that Foreman was qualified to render opinions on “comparative rates of infection for particular devices” because she had “vast FDA, regulatory, quality, and medical device industry experience” plus a master’s degree in biomedical engineering. The court disagreed. That Foreman held a master’s degree in biomedical engineering did not in itself qualify her to opine on port infection rates. Nor did her FDA experience, when her deposition testimony revealed that as an FDA reviewer she had never worked with port catheters.

The 510(k) process. The Consumers acknowledged Foreman could opine that in clearing a port device during the 510(k) process, the FDA determines that a device is “’as safe and effective’ as its predicate [device(s)],” but they argued she could not testify or imply that through the 510(k) process the FDA had determined Bard’s ports were “safe.” The court noted that the 510(k) process does not determine that a device is “safe and effective,” only that the device is substantially equivalent to the predicate device(s). In this case, Foreman’s opinions came close to stating that the FDA makes a safety determination in the 510(k) process, which is incorrect. Thus, if allowed to testify on FDA issues by the presiding judge, Foreman could describe the safety aspects of the 510(k) process as a comparative standard, but she could not opine or imply that it was an affirmative approval of product safety by the FDA.

FDA’s ‘state of mind.’ The Consumers cited Foreman’s opinions that the “FDA has not issued any public health notification related to implanted ports,” that “[n]o [522] study was ever ordered for Bard’s implantable port products,” and the “FDA has not proposed to change the classification of implantable port devices” as impermissible state-of-mind opinions. The court stated simply that these were not state-of-mind opinions. The Consumers also contended that Foreman should not be permitted to suggest that the FDA’s inaction meant the FDA had blessed Bard’s processes and products. The court agreed but noted that Foreman never stated such an opinion.

In similar fashion, the court reviewed challenges to Foreman’s document review and her opinions on cautionary statements, sufficiency of labeling, antimicrobial coatings, and her rebuttal of the Consumers’ experts. Granting the Consumers’ motion to exclude in part and denying it in part, the court ordered that Foreman could not opine (1) on port infection rates or comparative infection rates, (2) on patient or physician preferences, (3) that the FDA approved Bard’s labeling, or the instructions and warnings it contained, through the 510(k) process, (4) on chemical manufacturers’ reasons for issuing cautionary statements, or (5) on what the FDA perceived or believed.

The case is No. 2:23-md-03081-DGC.

Judge: Campbell, D.

Attorneys: Kimberly Lynn Boldt (Ratzan Weissman Boldt) for Lori Prentice, Jean Marie Cunningham and Patrice Terry. Adam J. Hegler (Nelson Mullins Riley & Scarborough LLP) for Becton Dickinson and Co., C R Bard Inc., Bard Access Systems Inc. and Bard Peripheral Vascular Inc.

Companies: Becton Dickinson and Co.; C R Bard Inc.; Bard Access Systems Inc.; Bard Peripheral Vascular Inc.

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