Breast Cancer Patient Sues Over Defective Bard PowerPort
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A Texas woman undergoing breast cancer treatment is suing the manufacturer of the Bard PowerPort after the device fractured and lodged in her heart.
Brandie Songy was implanted with the device in August 2022 for the delivery of chemotherapy drugs. She claims that less than a year later the device failed and she had to undergo emergency surgery to retrieve the broken port.
The complaint against C.R. Bard Inc., Bard Access Systems Inc. and parent company Beckton, Dickenson and Company was filed in U.S. District Court for the Eastern District of Texas in late July.
According to the complaint, Songy began feeling prolonged heart palpitations and shortness of breath on July 6. The following day she was scheduled for an outpatient chemotherapy infusion but doctors found an issue with the port.
An X-ray showed a five-centimeter piece of the Bard PowerPort catheter had broken off and lodged in Songy’s heart, according to Songy’s lawyers. She was sent to the hospital, where doctors performed emergency surgery to retrieve the catheter. More surgeries are expected later to remove the device and further evaluate her heart, the complaint states.
What Is the BardPort Implantable Port?
The BardPort Implantable Port is a device designed to provide repeated access to the patient’s vascular systems to deliver medications, intravenous fluids, nutrition solutions, blood products and to withdraw blood samples. The device is surgically implanted and has two primary parts: an injector port and a catheter.
Songy’s attorneys allege the company “had reason to know that the patients implanted with the device had an unreasonable risk of suffering life-threatening injuries.” Songy is suing for more than $75,000, but an exact amount was not disclosed.
Lawyers allege Bard knew its product was defective and had received “large numbers of adverse event reports from healthcare providers stating post-implantation the implanted port devices were (a) fracturing and migrating; (b) precipitating thromboembolism; and/or (c) precipitating infection. Defendants also received large numbers of AERs reporting that PowerPort was found to have perforated internal vasculature.”
According to the complaint, patients who experienced device failures sustained a variety of injuries, some fatal. Injuries included:
- Cardiac arrhythmia and other symptoms similar to myocardial infarction
- Cardiac/pericardial tamponade
- Hemorrhage
- Perforations of tissue, vessels and organs
- Severe and persistent pain
Despite allegations that there are thousands of recorded device failures, the “defendants continued to actively and aggressively market the Device as safe,” the complaint stated.
Bard Under Fire
C.R. Bard specializes in vascular, surgical, urology and oncology devices and became a wholly owned subsidiary of Becton, Dickinson & Company in 2017. C.R. Bard has faced various lawsuits throughout the years, including a high-profile case involving illegal human experiments in the 1990s.
In December 1993, Bard pleaded guilty in federal court to 391 criminal charges that included accusations of selling defective heart catheters, hiding problems with the catheters from the U.S. Food and Drug Administration and conducting illegal experiments on humans.
“For a company to engage in a pattern of using unsuspecting patients as guinea pigs and operating rooms as laboratories for unapproved products shows a blatant disregard for the health and safety of the patients who literally entrusted their lives to the company’s products,” FDA Commissioner David Kessler said at the time.
Bard agreed to pay $61 million in a settlement with the FDA and the U.S. Department of Justice. Three Bard executives were sentenced to 18 months in prison and three others were acquitted in separate trials.
In other litigation, Bard still faces active product liability lawsuits for its hernia mesh and IVC filter devices, although it settled the majority of its transvaginal mesh lawsuits in 2015.