Bellwether trial kicks off over Bard PowerPort catheter infection claims

PHOENIX (CN) — Opening statements began Tuesday in the first of six bellwether trials that will shape the future of more than 3,000 consolidated lawsuits accusing a global medical technology company of pushing dangerous products that cause septic infections and other life-threatening injuries.

Robert Cook of Minnesota was hospitalized for six days in 2022 after his Bard PowerPort catheter became infected, delaying chemotherapy treatments for colorectal cancer by two weeks and requiring surgery to remove the port catheter. In opening statements of a three-week federal trial in Phoenix, Cook’s attorney said Bard knew of the risks associated with its products for decades and took no action to improve safety or warn physicians and patients.

“The device that was supposed to help Mr. Cook, it hurt him,” Ciresi Conlin partner Michael Sacchet told nine jurors Tuesday afternoon in the Sandra Day O’Connor Courthouse. “Bard has done nothing to protect the ports from infection.”

Sacchet told the jury Bard’s port catheters, implanted under the skin and used to inject medical treatments like chemotherapy, antibiotics and IV fluids, have a near 15% infection rate. He said one study found a 59% overall complication rate.

David Cise, Bard’s port team leader who gave a deposition before the trial and will be called as a witness, said under oath the company has known about the associated risks of the product for years.

In a lawsuit filed in September 2023 against Becton, Dickinson and Company and its subsidiary C. R. Bard, Cook says Bard could have improved its product’s safety in three ways: with an antimicrobial coating that would kill bacteria on contact inside the body; with a non-fouling coating that would repel material from sticking to the catheter inside the body; and by increasing the smoothness of the catheter so that bacteria cannot cling to microscopic cracks and crevices.

In his opening, Sacchet displayed internal Bard communications suggesting high-ranking officials knew those improvements would increase the safety of their product.

Bard designed external catheters with antimicrobial coating as early as 2005, but the port catheters were different. Bard developed the improved product in 2009 and found it reduced bacteria by 99%. The FDA had more safety concerns, and Bard never received the green light.

“Bard didn’t do the homework that the FDA wanted it to do,” Sacchet said.

In 2012, Bard developed a non-fouling coating for port catheters, but, like before, the idea was never rolled out. In 2015, the company developed a smooth material “silk catheter,” but Sacchet said the company discontinued the product because it didn’t boost revenue.

More internal documents show Bard knew their port catheters were too rough. One internal message called the issue “the smoking gun.”

By 2020, Sacchet said more than 30 different safer technologies existed.

“Bard has still not done anything,” he said.

Representing Bard, Nelson Mullins attorney Richard B. North told a different version of the story.

“No other manufacturer of port catheters in this country sells them with antimicrobial coatings,” he told the jury. “The FDA has never cleared any antimicrobial coating for port catheters.”

Bard didn’t give up on antimicrobial coating when asked for further testing, as the plaintiff suggested, North said. Rather, the FDA raised serious concerns that the coating would come off the catheter while in the body and move through the bloodstream.

He called the catheters “a trusted, safe device,” and assured the jury that Bard gave proper warnings to all the involved parties. The doctor who implanted Cook’s port catheter, Tomas Frimpong, said in his deposition that he warned Cook about the risk of infection and that Cook signed a consent form acknowledging those risks.

North said the infection was not the fault of the device nor the doctor who implanted it.

Cook received the port catheter on Aug. 24, 2022. Because his chemotherapy treatment would take a few days to be fully injected, Cook was allowed to go home and disconnect the medication from his port himself. The Mayo Clinic in Rochester, Minnesota, trained Cook’s wife, Ann Marie Potter, how to safely disconnect the medication tubing and flush the catheter with saline in a sterile environment.

At home, Potter was assisted in disconnecting the port by a family friend, Megan McGuigan Oglesbee, who was not trained by the Mayo Clinic. In their depositions, the two give conflicting reports about who did what regarding the disconnection.

North said the at-home removal is likely where the infection took root.

After he was treated for the infection, Cook agreed to have a new Bard catheter implanted. North said Cook can’t claim he wouldn’t have accepted the device if properly warned, given that he accepted the new catheter after the infection subsided.

“Would some sort of different warning really make a difference here?” North asked.

After openings, Cook first called to the stand Dr. Darren Hurst, an interventional radiologist from Kentucky, who said his hospital moved away from Bard products in 2014. He will continue his testimony on Wednesday morning. U.S. District Judge David G. Campbell is presiding over this trial, the first six bellwether cases in the multi-district litigation.

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