Products Liability Law Daily Wrap Up, EXPERT EVIDENCE—MEDICAL DEVICES—D. Ariz.: Clinical experience alone supported medical expert’s safety and IFU opinions about Bard catheters, (Sep 18, 2026)

By Justin Marcus Smith, J.D.

While allowing the safety and IFU opinions, the court excluded opinions related to biomechanical materials science.

A medical expert’s substantial clinical experience supported general opinions about the safety and efficacy of implanted port catheters (IPCs) manufactured by C.R. Bard, Inc. (Bard) and other companies (collectively, Bard), held the federal district court in Phoenix, Arizona. The federal rules of evidence and applicable caselaw did not require the expert to cite a study comparing Bard IPCs to those of other manufacturers. Nor did evidence law require the expert to present objective data or analysis of his own patients’ outcomes to support his opinion that he had not seen clinical trials or cohort studies that Bard IPCs are less safe or less beneficial compared to other IPCs. The expert’s clinical experience likewise reliably supported opinions that did not implicate quantifiable comparative complication rates. The weight of the caselaw also held that clinical experience will qualify a physician to discuss instructions for use (IFU) adequacy warnings. However, the expert was not an engineer, so the court excluded opinions related to biomechanical materials science. Even so, the court found the expert was qualified to render rebuttal opinions to the extent they dealt with methodological flaws in the literature the patients’ experts cited (In Re: Bard Implanted Port Catheter Products Liability Litigation, No. 2:23-md-03081-DGC (D. Ariz. Sept. 8, 2026)).

Background. The instant multidistrict litigation (MDL) consolidated thousands of personal injury cases related to implanted port catheters (IPCs). The patients alleged that IPC manufacturers Becton Dickinson and Company, C.R. Bard, Inc., Bard Access Systems, Inc., and Bard Peripheral Vascular, Inc. (collectively, Bard) could have used safer alternative designs and manufacturing processes. The patients also alleged that Bard IPCs are more dangerous than other available treatment options.

More specifically, each patient in this MDL claimed that an implanted IPC, each of which had premarket clearance from the Food and Drug Administration (FDA), was defective and caused serious injury. They alleged the inclusion of barium sulfate, which makes IPCs visible on diagnostic imaging, caused degradation of the mechanical integrity of the catheter leading to catheter fracture, infection, and blood clots. They also alleged that the polyoxymethylene (POM) thermoplastic polymer used in the construction of the IPCs was subject to oxidative degradation with increased risk of catheter fracture, infection, and thrombosis. The patients also alleged that the palpation bumps on power-injectable Bard IPCs caused undue compression stress on the tissue surrounding the port, which then caused ulceration and tissue necrosis.

The patients 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.

Bard disputed the allegations and contended that its IPCs are safe and effective and that the medical community is aware of IPC risks. Bard further contended that various factors impact the performance and wear of IPCs, including insertion location and how well medical professionals and the patient maintain the device.

The patients moved to exclude the opinions of the patients’ expert physician, a board-certified diagnostic radiologist, under Fed. R. Evid. 702. The expert claimed to have implanted and removed thousands of ports from numerous manufacturers, and his “most extensive” experience was with Bard IPCs. The patients argued the court ought to exclude the expert’s opinions because he based them on his own personal experience or on the anecdotal experience of colleagues.

The patients faulted only the expert’s opinions that IPCs can be enormously beneficial; that patients are aware of IPC risks; that he has seen no randomized clinical trials or studies that Bard ports are relatively less useful; and that none of the potential complications in the Bard port IFUs are more common in Bard ports than other ports in his experience. The patients urged that the expert provided no scientific or analytical basis for these conclusions, nor did he cite any peer-reviewed literature or comparative data to support them.

Safety, efficacy. The court ruled that Bard showed, by a preponderance of the evidence, that the expert used his clinical experience and medical literature to support his IPC safety and effectiveness opinions. The expert’s “substantial experience” supported his general opinions on port safety and efficacy. The expert’s report described his extensive clinical experience with IPCs and Bard IPCs in particular. His practice called for familiarity with the risks and benefits of IPCs. The expert also regularly taught radiology residents and vascular surgery fellows on how to implant and remove IPCs. The court found the medical literature the expert cited further supported his safety and efficacy opinions.

Cases the patients cited were distinguishable because they ruled on expert opinions discussing complication rates or patient outcomes, quantifiable opinions the patients did not attack here. In those cases, courts excluded expert opinions because they involved inadequate sample sizes, not because the experts based them on personal experience.

The patients also cited a ruling by the instant court from a previous MDL excluding the expert opinion that Bard IVC filters had higher complication rates than other manufacturers. That, too, was a quantifiable opinion that required supporting data, and it was different from the instant expert’s opinion based on his own experience.

The court ruled the expert did not have to cite a study comparing Bard ports to those of other manufacturers or objective data or analysis of his own patient outcomes. The expert did not need such things to opine how he had not seen randomized clinical trials or prospective cohort studies that Bard ports are less safe or less beneficial compared to other IPCs. The expert did not claim that Bard ports are safer than those of other manufacturers.

The court also noted it should be expected that the expert would have expert knowledge partly based on the experiences of colleagues at several hospitals where the expert worked and taught. The expert could not opine about the specific experiences of colleagues, but that was something the patients did not contest.

Complication rates. The patients made an off-point argument that the court ought to exclude the expert’s opinion to the extent he sought to testify that Bard ports have relatively lower complication rates. The patients cited the same reasons for exclusion, but they did not cite to such opinion of this expert, and Bard confirmed their expert did not render such an opinion. Again, the expert’s clinical experience reliably supported opinions that did not implicate quantifiable comparative complication rates. The expert’s review of literature adequately supported a related opinion, which the patients did not cite, that he did not find rates of risk in medical literature suggesting that Bard ports have higher complication rates.

Port design. The court agreed with the patients that the expert was not qualified under R. 702(a) to opine about port design or defect. The expert acknowledged during his deposition that he was not an engineer. He conceded that interventional radiologists and other physicians do not go into great detail about materials engineering because they are not biomechanical engineers. In this context, the expert could not rely on medical literature alone to inform his design opinion about choice of catheter material, and the court excluded it.

However, the court found the expert was qualified to render rebuttal opinions to the extent they dealt with methodological flaws in the literature the patients’ experts cited. The court disagreed with the patients’ argument that the rebuttal opinions were beyond the scope of the expert’s qualifications. The opinions did not discuss port material or design. The expert rebutted that the opinions of the patients’ medical experts on catheter material and coatings were “beyond the scope” of international radiologists and other physicians, and the patients did not challenge the expert’s qualifications to discuss literature methodology.

However, the expert could not, via rebuttal, opine on catheter coating risks. Nor could the expert merely repeat the findings of other experts. Cases Bard cited were distinguishable because they involved clinical experience the expert in this case did not have. The instant expert did not claim to have worked with various port catheter materials in his practice as an interventional radiologist.

IFUs. The weight of the caselaw held that clinical experience would qualify a doctor to discuss IFU adequacy warnings. The instant expert’s report stated that the IFUs he reviewed warned of all complications he described in detail in his report. He opined that the IFUs were consistent with the IFUs of other port products he had used and that port risks and complications have been well reported in the medical literature for a long time. The expert’s knowledge of port risks and his experience relying on IFUs in his own clinical practice qualified him to opine about Bard IFUs. The court further held the expert did not need to have experience drafting IFUs to opine about their content.

The expert did not opine on whether Bard sufficiently warned about known complications, so his own clinical experience provided a sufficient factual basis for his opinions on whether the Bard IFUs contained information on widely-known complications. Other patient critiques were off-point because the expert did not opine in a way relevant to the criticisms.

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

Judge: Campbell, D.

Attorneys: Kimberly Lynn Boldt (Ratzan Weissman Boldt) for Lori Prentice. Adam J. Hegler (Nelson Mullins Riley & Scarborough LLP) for Becton Dickinson and Co.

Companies: Becton Dickinson and Co.

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