The catheter manufacturer asserts a defense in a product liability, negligence lawsuit


PHOENIX (CN) – Tensions ran high on the final day of testimony in a bellwether trial representing more than 3,000 product liability claims against a global medical technology company.

An expert witness told a nine-person jury Wednesday that the infection of plaintiff Robert Cook’s port catheter occurred during the removal of home access to his chemotherapy treatment, rather than during surgical implantation — shifting the blame from catheter manufacturer CR Bard.

“I think she inadvertently didn’t follow all the steps,” said infectious disease specialist Ban Allos. Cook’s wife, Ann Potterwho discontinued Cook’s treatment two days after a Mayo Clinic surgeon implanted the port catheter in his chest. “I don’t believe she followed all the steps, or the infection wouldn’t have happened.”

Cook’s attorney, Michael Sacchet, protested. “You haven’t even seen Mayo’s instructional video to be able to tell that,” he said.

“I watched both videos,” Allos replied.

“Not before you wrote your report,” Sacchet replied.

cook unsuspecting in 2023, months after his catheter infection led to a six-day hospitalization that delayed his chemotherapy treatment by a month. Cook says Bard knew the risk of infection posed by his port catheters and failed to do both warn doctors and patients of that risk and of develop a material more resistant to infection. He is the first of six bellwether trials in multi-district litigation in the district of Arizona.

After initially placing his port catheter in Rochester, Minnesota, Mayo Clinic staff allowed Cook to open his port at home to save him the two-hour trip back to the hospital, which is common practice.

Megan Ogelsbee, a family friend and physician’s assistant, assisted Potter during the removal of access. In her deposition, she and Potter did everything correctly and did not recall any instances in which the port or equipment could have been contaminated. Nurses at the Mayo Clinic later told her they did not suspect a mistake had been made at home.

“You’re telling the jury that the lack of access was the cause of the infection, but you weren’t even there and the person who was there said there was no concern,” Sacchet said in a Phoenix federal court. “The person who was there, no worries. You not there, worries.”

Bard’s attorney, Richard North, objected several times during cross-examination, accusing Sacchet of inflating his arguments. U.S. District Judge David G. Campbell threw out the lion’s share, but reminded Sacchet that he can only ask questions; offers no comment.

Allos objected to most of his questions, she could not answer yes or no, to which he repeatedly asked and directed her to her deposition whenever she refused.

“I think you’re taking things out of context and making me say things I didn’t say and giving me opinions I don’t have,” she said.

Sacchet continued to pressure Allos.

“Do you have zero evidence that there was any wrongdoing?” he asked.

“There can be none,” Allos said, meaning nothing was reported in Cook’s medical records.

“Because you have none,” said Sacchet. “You have no evidence.”

Outside the jury’s presence, Campbell, appointed by George W. Bush, noted that the jury’s conviction that the infection occurred at home does not absolve Bard of liability unless Bard proves negligence on behalf of Potter or Oglesbee.

“So you agree that infections happen even when everyone follows the rules?” Sacchet had asked before.

“Yes that is true,” Allos replied.

Sacchet added that there is no way for Allos to know whether the doctor or nurses at the Mayo Clinic made a mistake while implanting the catheter.

“Do you agree that even nurses often make mistakes, right?” he asked.

“Everyone does,” Allos replied.

“Including the nurses who implanted Mr. Cook’s port?” he asked.

“Include the nurses,” she replied.

Because of the experience and expertise of the doctor who implanted it and a 0.05% infection rate when the Mayo Clinic implants port catheters, Allos said it was “highly unlikely” that Cook’s catheter was infected at the time of implantation.

Cook’s lawyers objected to the mention of Mayo’s infection rate as it was excluded from the testimony by the court, so Campbell ordered the jury to forget the testimony.

Chad Modra, vice president of quality management at Bard and the last witness the company called, told the jury that according to complaint reports, the infection rate in its port catheters is less than 1%. Throughout the three-week trial, the plaintiffs cited studies suggesting an infection rate of up to 14%.

Closing arguments are scheduled for Thursday morning.

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