Leading catheter company fights negligence claims in federal trial 

PHOENIX (CN) —  A former research director at C.R. Bard defended the medical technology company in federal court Wednesday from accusations it neglected viable new technologies that could have prevented infections in patients with implanted port catheters.

Though patients in more than 3,000 federal lawsuits claim otherwise, medical engineer Kelly Christian said Bard, a subsidiary of Becton Dickinson and Company, tested and evaluated numerous products designed to prevent port catheter infections, but none proved safe enough for human use.

“You can’t just make a technology and then throw it on a product and put it out there and say that it works,” Christian told nine jurors in a Phoenix courtroom Thursday morning. “There’s a lot that goes into it.”

Robert Cook, who went into sepsis in 2022 after suffering an infection from a port catheter used to transfuse chemotherapy, said in a 2023 lawsuit Bard ignored specific antimicrobial and anti-blood-clotting coatings it could have applied to its port catheters as early as 2005. Christian said his team at Bard studied and tested those technologies, but they didn’t perform as other companies may have advertised them.

To date, the U.S. Food and Drug Administration has never approved an antimicrobial coating for a port catheter for use in the United States. Bard’s competitors have developed other technologies over the years said to reduce infection rates, but Christian said no clinical studies have proven those claims.

In 2014, AngioDynamics introduced a technology called Endexo, using a hydrophobic polymer to prevent liquid from sticking to the catheter. Christian said the material was so hydrophobic, it pulled gas out of the fluid in the catheter, creating air bubbles in the tube that would temporarily stop the medicine flow.

Coupled with concerns the Endexo would weaken the burst strength of the catheter itself, Bard decided the risks outweighed the potential benefit.

“It was almost a no-brainer not to proceed with it,” Christian said.

Another medical device company, Teleflex, claimed its catheter coating called Semprus would attract water to protect it from antibodies and prevent bacteria build-up and blood clotting. But the company was never able to mass produce the technology and it never went public. Christian said Bard had other safety concerns regardless.

The closest Bard got to an antimicrobial port catheter was a technology called Covolar, but it never received FDA approval. The FDA responded to its application with additional questions three times over the course of a year, prompting Bard to shelve the idea. Kelly said the product worked, but Bard couldn’t prove it to the FDA “without inventing a new kind of science.”

“We had essentially done everything we could,” Christian added.

Based on his time at Bard, Christian avowed no other technology is safer than Bard’s Chronoflex, introduced in 1990, which he called “a wonderful catheter material.” But Christian hasn’t worked for Bard since 2013.

“You have no opinion as to Bard’s ability to sell an antimicrobial port after 2013,” plaintiff attorney Michael Sacchet said on cross examination.

Sacchet claimed Bard could have achieved FDA clearance on Covolar, but it “failed to do its homework.” He said the FDA asked for additional testing and data, and the FDA complained Bard didn’t provide the information it had previously asked for.

“They said that, but we did,” Christian countered. “I know what they said and I know what we submitted. And I’m sorry, but they were wrong.”

Sacchet asked why Bard never asked the FDA for approval of other antimicrobial port catheters. Christian repeated that different types of catheters have different requirements, and no clinical studies have shown antimicrobial coatings reduce infection rates.

“My job was not just to find a coating but to find something that actually prevents infection,” he said.

Cook’s port catheter became infected just days after his wife and a family friend helped him de-access his chemotherapy treatment from the device, less than 10 days after it was implanted at the Mayo Clinic in Minnesota.

Bard’s attorneys have suggested the infection was caused by user error, but Christian’s testimony contradicted.

He said it’s a “rule of thumb” if an infection occurs within 10 days of implant, then the infection was likely caused during the surgical implant rather than during access or de-access later. Sacchet asked whether anything Cook’s wife did at home could have caused the infection.

“If the bacteria got into the wound during a surgical procedure, no,” Christian answered.

The defense began its case-in-chief Wednesday morning with video deposition from the surgeon who implanted Cook’s catheter. Dr. Tomas Frimpong said he didn’t hesitate to replace the infected catheter with another Bard PowerPort catheter, which Bard says proves physicians are aware of the risks and know they are outweighed by the product’s benefits.

The trial is scheduled to wrap up next week, but U.S. District Judge David G. Campbell said he’s concerned about the current pace of testimony.

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