PHOENIX (CN) – A former director of research at CR Bard defended the medical technology company in federal court Wednesday against allegations that it neglected to develop viable new technologies that could have prevented infections in patients with implanted port catheters.
Although 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 it works,” Christian told nine jurors in a Phoenix courtroom Thursday morning. “There’s a lot to it.”
Robert Cook, who went into sepsis in 2022 after suffering an infection from a port catheter used for chemotherapy transfusions, said in a 2023 lawsuit that Bard ignored specific antimicrobial and anti-clotting coatings it could have applied to his port catheters as early as 2005. Christian said his team could have studied other technologies at Bard, but they had studied other technologies at Bard. advertised them.
To date, the US 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 that are said to reduce infection rates, but Christian said no clinical studies have substantiated those claims.
In 2014, AngioDynamics introduced a technology called Endexo, using a hydrophobic polymer to prevent fluid from sticking to the catheter. Christina said the material was so hydrophobic that it outgassed the fluid in the catheter, creating air bubbles in the tube that would temporarily stop the flow of the drug.
Along with concerns that Endexo would weaken the burst force of the catheter itself, Bard decided the risks outweighed the potential benefit.
“It was almost a no-brainer not to go ahead with it,” Christian said.
Another medical device company, Teleflex, claimed that its catheter coating, called Semprus, would attract water to protect it from antibodies and prevent bacterial 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 thing to an antimicrobial port catheter was a technology called Covolar, but it never received FDA approval. The FDA responded to her application with additional questions three times over the course of a year, prompting Bard to abandon 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 basically done everything we could,” added Christian.
Based on his time at Bard, Christian acknowledged that no other technology is safer than Bard’s Chronoflex, introduced in 1990, which he called “an amazing catheter material.” But Christian hasn’t worked for Bard since 2013.
“You have no opinion about Bard’s ability to sell an antimicrobial port after 2013,” plaintiff attorney Michael Sacchet said during cross-examination.
Sacchet claimed that Bard could have achieved FDA approval for Covolar, but it “failed to do its homework.” He said the FDA requested additional testing and data, and the FDA complained that Bard did not provide the information it had previously requested.
“They said that, but we did it,” Christian countered. “I know what they said and I know what we presented. And I’m sorry, but they were wrong.”
Sacchet questioned why Bard never asked the FDA for approval of other antimicrobial port catheters. Christian reiterated that different types of catheters have different requirements, and no clinical studies have shown that antimicrobial dressings 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 that the wife and a family friend helped him tear his chemotherapy treatment from the device, less than 10 days after it was implanted at the Mayo Clinic in Minnesota.
Bard’s lawyers have suggested the infection was caused by user error, but Christian’s testimony contradicted that.
He said it is a “rule of thumb” if an infection occurs within 10 days of implantation, then the infection is likely to have been caused during surgical implantation and not during access or de-accession later. Sacchet asked if anything Cook’s wife did at home could have caused the infection.
“If bacteria entered the wound during a surgical procedure, no,” Christian replied.
The defense began its case-in-chief Wednesday morning with a video deposition from the surgeon who implanted Cook’s catheter. Dr. Thomas Frimpong said it did not hesitate to replace the infected catheter with another Bard PowerPort catheter, which Bard says proves doctors are aware of the risks and know they are outweighed by the product’s benefits.
The trial is scheduled to end next week, but US District Judge David G. Campbell said he is concerned about the current pace of testimony.
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