A significant federal trial commenced Tuesday in Phoenix, marking the first of six bellwether cases that will influence the outcome of over 3,000 consolidated lawsuits against medical device manufacturer Becton, Dickinson and Company and its subsidiary C. R. Bard. The cases center on allegations that the company’s PowerPort catheters cause severe infections and other serious medical complications.
The plaintiff, Robert Cook of Minnesota, underwent hospitalization for six days in 2022 after his Bard PowerPort catheter became infected. The infection forced doctors to delay his colorectal cancer chemotherapy treatments by two weeks and necessitated surgical removal of the device. Port catheters are medical devices implanted beneath the chest skin to administer medications such as chemotherapy, antibiotics, and intravenous fluids.
During opening statements at the Sandra Day O’Connor Courthouse, Cook’s attorney Michael Sacchet from Ciresi Conlin argued that Bard had knowledge of the risks associated with their products for decades but failed to implement safety improvements or provide adequate warnings to medical professionals and patients. Sacchet presented evidence suggesting the devices have an infection rate approaching 15 percent, with one study indicating a 59 percent overall complication rate.
According to the plaintiff’s legal team, internal company communications reveal that Bard executives were aware of three potential safety improvements that could have been implemented. These included applying an antimicrobial coating to eliminate bacteria on contact, developing a non-fouling coating to prevent material adhesion to the catheter, and creating a smoother catheter surface to prevent bacterial attachment to microscopic irregularities.
Sacchet detailed Bard’s development timeline, noting the company created external catheters with antimicrobial coating in 2005 and developed an improved product in 2009 that reduced bacteria by 99 percent. However, the product never received regulatory approval. The company also developed a non-fouling coating in 2012 and a smooth “silk catheter” in 2015, but neither advancement was implemented in their port catheter products.
Defense attorney Richard B. North from Nelson Mullins presented a contrasting narrative, emphasizing that no port catheter manufacturers in the United States currently sell products with antimicrobial coatings and that regulatory authorities have never approved such coatings for these devices. North explained that when Bard attempted to develop antimicrobial coatings, regulators raised serious safety concerns about the coating potentially detaching inside the body and entering the bloodstream.
The defense argued that Cook’s infection resulted from improper handling during home care rather than device defects. Cook received his port catheter on August 24, 2022, and was permitted to disconnect his chemotherapy medication at home. While medical staff at the Mayo Clinic in Rochester, Minnesota, trained Cook’s wife, Anne Marie Potter, in proper sterile disconnection procedures, a family friend who lacked this training assisted with the process. The defense suggests this home disconnection likely introduced the infection.
North also highlighted that Cook accepted a replacement Bard catheter after recovering from the infection, questioning whether different warnings would have influenced his decision given his willingness to use the same manufacturer’s product following his negative experience.
The trial’s first witness, Dr. Darren Hurst, an interventional radiologist from Kentucky, testified that his hospital discontinued using Bard products in 2014. His testimony will continue Wednesday.
U.S. District Judge David G. Campbell is overseeing this three-week trial, which represents the first in a series of six bellwether cases within the multi-district litigation. These initial trials will establish precedents that could significantly impact the resolution of the thousands of pending cases against the medical device manufacturer.
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