A major medical technology corporation is defending itself in federal court against allegations that it failed to implement available technologies that could have prevented infections in patients with implanted port catheters used for chemotherapy treatments.
The case, being heard in a Phoenix federal courtroom, involves more than 3,000 federal lawsuits filed by patients who claim C.R. Bard, a subsidiary of Becton Dickinson and Company, neglected to adopt antimicrobial coatings and other protective technologies for its port catheter products.
Kelly Christian, a former research director at the company who worked there until 2013, testified Thursday that the medical device manufacturer extensively tested and evaluated numerous products designed to prevent port catheter infections. According to Christian, none of the tested technologies proved safe enough for human use.
The central plaintiff in the current trial is Robert Cook, who experienced sepsis in 2022 following an infection from a port catheter used for chemotherapy transfusions. Cook filed his lawsuit in 2023, alleging the company ignored specific antimicrobial and anti-blood clotting coatings that could have been applied to its port catheters as early as 2005.
Christian disputed these claims during his testimony, explaining that his team thoroughly studied and tested the technologies in question, but they failed to perform as advertised by other companies. He emphasized that the U.S. Food and Drug Administration has never approved an antimicrobial coating for port catheters in the United States.
During his testimony, Christian detailed specific examples of technologies the company evaluated. In 2014, competitor AngioDynamics introduced Endexo technology, which used a hydrophobic polymer to prevent liquid from adhering to catheters. However, Christian testified that the material was so hydrophobic it created air bubbles in the tube that would temporarily stop medicine flow. Combined with concerns about weakening the catheter’s burst strength, the company decided against pursuing this option.
Another technology called Semprus, developed by Teleflex, claimed to attract water to protect against antibodies while preventing bacteria buildup and blood clotting. Christian noted that Teleflex was never able to mass produce this technology, and it never became publicly available.
The company came closest to developing an antimicrobial port catheter with a technology called Covolar, but it never received FDA approval. According to Christian, the FDA responded to the application with additional questions three times over the course of a year, ultimately leading the company to abandon the project. Christian maintained that while the product worked, the company couldn’t prove its efficacy to the FDA without developing entirely new scientific methods.
During cross-examination, plaintiff attorney Michael Sacchet challenged Christian’s testimony, suggesting the company could have achieved FDA clearance on Covolar but failed to provide the necessary testing and data requested by regulators. Christian firmly rejected this assertion, stating that the company had submitted the requested information and that the FDA was mistaken in its assessment.
Cook’s infection occurred just days after his wife and a family friend helped him de-access his chemotherapy treatment from the device, less than 10 days after its implantation at the Mayo Clinic in Minnesota. While defense attorneys have suggested user error caused the infection, Christian’s testimony appeared to contradict this theory. He stated that infections occurring within 10 days of implant are typically caused during the surgical procedure rather than during later access or de-access.
The defense presented video deposition testimony from Dr. Tomas Frimpong, the surgeon who implanted Cook’s catheter. Frimpong testified that he didn’t hesitate to replace the infected catheter with another PowerPort catheter from the same manufacturer, which the defense argues demonstrates that physicians understand and accept the risk-benefit profile of the product.
The trial, overseen by U.S. District Judge David G. Campbell, is expected to conclude next week, though the judge has expressed concerns about the current pace of testimony proceedings.
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