Surgeon calls PowerPort catheter infection warnings inadequate in federal trial

PHOENIX (CN) —  An expert witness in a federal product liability trial against a global medical technology company said Wednesday the company failed to adequately warn physicians and patients of the risk of port catheter infections.

Interventional radiologist Darren Hurst, testifying on behalf of a Minnesota man who went into sepsis due to an infected port catheter, said the instructions for use of Bard’s PowerPort catheters downplay the risk of infection by including it under “possible complications” rather than under “warnings.” He said the instructions make no mention of the statistical likelihood of infection from a port catheter, which is around 14%, and do not adequately describe the type of material.

On cross-examination, however, Hurst admitted that the ports he uses in his hospital in Kentucky aren’t much better when it comes to warnings.

“No port IFU contains infection rates,” he said, referring to the instructions for use. “And they’re all insufficient.”

Robert Cook was hospitalized for six days in 2022 after his chest-implanted Bard PowerPort catheter became infected, delaying chemotherapy treatments for colorectal cancer by two weeks and requiring surgery to remove the port catheter. In a lawsuit filed in September 2023 against Becton, Dickinson and Company and its subsidiary C. R. Bard, Cook says Bard knew of the risks associated with its products for decades and took no action to improve safety or warn physicians and patients.

In opening statements Tuesday, Bard defense attorney Richard North of Nelson Mullins in South Carolina, suggested the infection was preventable, and was caused through personal error when Cook and his wife disconnected his chemotherapy treatment from the port device at home.

On Wednesday, Hurst said doctors regularly allow patients to disconnect their devices at home, calling the procedure simple and straightforward.

“If we thought there was increased risk, we would just keep them in the hospital,” he said.

Before going home, Cook’s wife, Ann Marie Potter, was trained to disconnect the device by staff at the Mayo Clinic in Rochester, Minnesota. In her deposition, she said she wasn’t actually the one to do the disconnection. Rather, it was family friend Megan McGuigan Oglesbee, who was not similarly trained. In her deposition, Oglesbee said it was Potter who disconnected the device.

“I’m not sure it matters,” Hurst said.

Hurst said there’s no evidence the infection was caused when the device was disconnected from home, but said it could have happened anytime, anywhere, including at the hospital or during the 46-hour chemotherapy infusion.

“It could have come from brushing his teeth,” he said.

Hurst added that Bard provides no special instructions to patients for safe at-home disconnection, and nothing in the patient guide mentions an increased risk of infection from home de-access. The consent form Cook signed similarly contained no mention of risk of infection.

On cross, Bard defense attorney Edward Fanning of the New England-based McCarter and English clarified the doctor who implanted Cook’s catheter goes over all risks, including infection, with the patient before every procedure. Hurst did not disagree.

Cook pointed to a 2020 study that found a 59% complication rate in the first five years after a patient is implanted with a port catheter. But the data applies to all port catheters in the Medicare system and makes no mention of Bard products specifically.

Internal documents introduced into evidence Wednesday suggest Bard employees have been aware for some time of the risk of infection from port catheters. One document shows physicians in the past have requested port catheters that are immune to blood clotting.

Another suggests one in three nurses note port infections as a major problem in their facilities, and 27% of interventional radiologists report infections as the most common reason to see a patient with an implanted port catheter.

Fanning noted infection is a real risk any time a medical device is implanted in the body, to which Hurst agreed.

After the infection was treated, Cook has a new port implanted using the same type and size of catheter, signing a consent form for the second time. Fanning said Cook can’t claim he wouldn’t have accepted the device if properly warned, given he readily accepted the new catheter.

Wednesday afternoon, the jury watched video from the deposition of David Cise, the port project leader at Bard. More internal documents revealed Cise referred to chronoflex, the patented material used to make Bard PowerPort catheters, as “dirt.” Cook claims the company knew the material is prone to microscopic cracking that allows bacteria to cling to it and silicone catheters would be smoother and less likely to become infected.

Cise wrote “No more chronoflex!!!” in one message to administrators.

Cise said in his deposition the company has known about the 14% infection rate for years.

The trial is scheduled to continue until May 8.

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