Bard catheter infection negligence trial heads to jury

PHOENIX (CN) — A nine-person jury will soon decide whether a global medical technology company is liable for a sepsis-inducing infection a cancer patient suffered from his chest-implanted port catheter.

Attorneys made closing arguments Thursday after three days of trial accusing C.R. Bard, a subsidiary of Becton Dickinson and Company, of product liability and negligence in making and marketing its port catheters. Robert Cook, a cancer patient who sued in 2023 after his infection led to a six-day hospitalization and 30-day delay in chemotherapy treatment, is just one of thousands of plaintiffs in a multidistrict litigation based in Arizona.

In his closing, Cook’s attorney Michael Sacchet said Bard knew its products posed a serious infection risk as early as 1999 and refused to make necessary safety upgrades.

“There’s no debate in this case that this material is a magnet for bacteria,” he said of Bard’s patented port catheter material. “It allows bacteria to stick, build a nest, grow and blow, causing a bloodstream infection.”

Cook’s team presented the jury with multiple technologies designed to reduce infection rates in catheters, some tested by Bard, but none implemented.

Representing the company, attorney Richard B. North said that was for good reason. Unlike most catheters, port catheters are implanted entirely inside the body, making antimicrobial and other infection resistant coatings more complicated to make safely. Many of the products used by other companies or by Bard on other types of catheters couldn’t safely work on port catheters, he said.

“When we tried to develop one for ports, the FDA refused to clear it,” North said. “You saw all the efforts we made over the years.”

The FDA has approved no antimicrobial coatings for port catheters.

“They could point to no other company that succeeded where we didn’t,” North said.

North argued the benefit of having a port catheter far outweighs the risk of infection, which was less than 1% at Cook’s hospital.

But Sacchet said even the company’s own employees know that’s not true. Sacchet reminded jurors of internal documents they’ve viewed, one in which a port team leader refers to catheter material as “older than dirt.”

“Their response at trial was that he was joking,” Sacchet denounced. “How disrespectful. These are cancer patients we’re talking about.”

Sacchet pointed jurors to studies examining infection rates in port catheters. In one, researchers found a 14.8% infection rate in Bard ports. The defense countered with stats from the Mayo Clinic but provided no studies of its own.

After first implanting his port catheter in Rochester, Minnesota, Mayo Clinic staff allowed Cook to de-access his chemotherapy treatment from his port at home to save him the two-hour trip back to the hospital, which is common practice. At trial, an expert witness for Bard said the infection was likely the fault of Cook’s wife, Ann Potter, who helped him de-access the port. She said Potter must have inadvertently contaminated the equipment.

In his closing, Sacchet pulled at jurors’ heartstrings in Potter’s defense.

“Blame that woman right there,” he said, pointing to Potter in the gallery. “Blame her. She’s at fault for caring for her husband through 10 years of cancer. Blame her.”

One juror wiped a tear from her eye while the rest looked at Potter.

“That’s not right,” Sacchet continued. “That’s why I’m here. To defend them from this.”

Sacchet argued that Potter couldn’t have contaminated the catheter because infection started on the outside of the tube, and she could only access the inside through the port.

Cook accuses Bard of design defect and failure to warn, arguing that if the company wasn’t able to make its products safer, it at least could have warned patients of the risk.

Multiple witnesses at trial testified that at-home de-accessing carries no higher risk of infection than doing so in a hospital setting.

“They came in here and blamed Miss Potter, saying it does,” Sacchet said. “If they’re right, where’s the warning?

He said the product’s instructions for use make no mention of infection or sepsis under the warning label.

North argued that Bard fulfilled its legal obligation to warn Cook of the risk because it warned a “learned intermediary,” who in this case was his surgeon. From there, surgeons can use their discretion as to how much of the warning they pass on to the patient.

Sacchet complained that no mention of infection or sepsis appears on the warning label, but those things are mentioned in a section called “possible complications.”

“It doesn’t matter what section it’s in,” North said. “The IFU is still alerting the doctor to what Dr. Frimpong already knew: that sepsis is a risk with catheters.”

Cook did not request a specific dollar amount in damages. If the jury decides in Cook’s favor, then the court may proceed with a separate hearing on punitive damages.

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