Medical tech company not liable for infections in catheter patients

PHOENIX (CN) — A nine-person jury on Friday found the medical device company C.R. Bard not liable for negligence regarding the safety and efficacy of its port catheters, which caused a life-threatening infection in Minnesota man Robert Cook.

The jury found Bard not liable on counts of consumer fraud and failure to warn or instruct. Jurors couldn’t reach a unanimous verdict regarding accusations of design defect and unlawful trade practices.

“We’re obviously disappointed, but the goal of this process was to give me the chance to tell my story in the hopes that a change is made and that other people don’t have to suffer what I went through,” Cook said. “To that end, I think we were successful.”

Cook sued in 2023 after an infected port catheter he used to transfuse chemotherapy resulted in a six-day hospital stay and a 30-day delay of his cancer treatments. Cook says Bard, a subsidiary of Becton Dickinson and Company, knew its products caused infections at alarming rates and did nothing to improve safety or warn physicians and patients.

Cook’s is just one of more than 3,000 lawsuits consolidated into a multi-district litigation against the global technology company before U.S. District Judge David G. Campbell in Arizona federal court. This was the first of six bellwether trials chosen to help set precedent for future litigation.

“In spite of the verdict, hopefully this serves as a catalyst for not just Bard but for all medical manufacturers,” Cook said. “I am optimistic that this process, not just my case but the other bellwethers, will force change.”

In a three-week trial, Cook’s attorneys told the jury of multiple antimicrobial and anti-blood clotting technologies that the company could have used to coat its chest-implanted catheters to reduce infection rates. He says Bard ignored those technologies for one reason or another, opting to stick with what was easiest at risk of patient safety.

Bard employees testified that they worked diligently to develop safer technologies like an antimicrobial coating for port catheters, but were faced each time with safety issues that counteracted the perceived benefit of an infection-resistant catheter.

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 former research director Kelly Christian testified that no clinical studies have proven those claims.

The jurors could not decide whether Bard’s port catheter design was defective. After delivering their verdict, jurors told attorneys outside the courtroom that seven of the nine said it was not, while two said it was.

The foreperson, who did not give his name, said the jury found the verdict form questions confusing. Multiple jurors agreed that if a question asked whether the device could have been designed to be safer, they would have answered yes.

Learning after their verdict that the case represents a multi-district litigation of thousands, some jurors said they would have been more likely to find Bard liable if they were shown evidence of a pattern or practice.

Cook was implanted with a port catheter on Aug. 24, 2022 at the Mayo Clinic in Rochester, Minnesota. While there, staff trained Cook’s wife, Ann Potter, to de-access the medication tubing from the port itself at home so that Cook didn’t need to stay three nights in the hospital.

Potter and family friend Megan McGuigan Oglesbee, who was not trained by the Mayo Clinic, worked together to de-access Cook’s port. Cook’s port became infected days later.

Cook called Bard blaming his wife a cheap shot.

“I stand by now as I did then that they did absolutely nothing wrong,” he said. “Everyone we spoke to at the Mayo Clinic and United Hospital said they didn’t do anything wrong.”

Bard’s attorney Richard B. North suggested that the two performed the procedure incorrectly and likely caused the infection. But Christian told the jury that, as a general rule of thumb, an infection less than 10 days after implantation is more likely a result of the implantation itself than any de-accessing done later.

Potter testified that she was never told at-home de-accessing carried a higher risk of infection, and would not have done so if any increased risk were apparent. A radiologist called as an expert witness examined Bard’s products and agreed that Bard provided no special instructions for safe at-home de-accessing, 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.

After Cook’s catheter was surgically removed, he opted again to receive the same type and size catheter that first caused him problems. The doctor who implanted it, Tomas Frimpong, said he didn’t hesitate to replace the infected catheter with another Bard PowerPort catheter. Cook agreed to receive the same port as well.

Bard says their readiness to assume the risk even after the infection proves that both physicians and patients know the risk and understand that it’s far outweighed by the benefit of chemotherapy via port catheter.

Cook pointed to internal documents in which Bard’s own employees suggested they knew the catheters were inaccurate. In one instance, port project leader David Cise called the catheter material, chronoflex, “older than dirt,” and celebrated when he thought the company might upgrade the material. He said in another document that Bard had been aware for years of a 14% infection rate in its products.

Bard said Cise’s comments were “facetious” and not to be taken seriously. The company acknowledged the high infection rate but assured the jury it had done and is doing everything it can to reduce it.

Cook’s attorney, Thomas Pirtle, said Cook will return to court to retry the two hung counts.

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