Johanna Randow, a Maryland resident undergoing treatment for breast cancer, recently took legal action against C.R. Bard and Bard Access Systems, alleging severe complications arising from the Bard Infuse-A-Port device used in her treatment. Randow’s lawsuit, filed in the U.S. District Court for the Eastern District of Texas on September 19, is part of a growing number of legal actions against the manufacturers.
The Bard Infuse-A-Port, an implantable port catheter system, is designed to facilitate the delivery of medications, including chemotherapy, by providing easy access to a patient’s vascular system. However, Randow’s case, along with others, highlights significant issues with the device’s safety and effectiveness.
Randow’s ordeal began in late April 2018 when she underwent the surgical implantation of the Bard Infuse-A-Port as part of her cancer treatment. Within a year, complications arose, leading to the removal of the device in July 2019 due to its malfunction.
However, the most severe consequences came to light in November 2021 when Randow experienced a pulmonary embolism, a potentially life-threatening condition caused by a blood clot in the lungs. Subsequent medical examinations revealed that a fragment of the Bard Infuse-A-Port catheter had fractured and lodged in her heart, putting her at ongoing risk of further complications and necessitating additional surgeries and treatments.
The Bard Infuse-A-Port has been subject to previous recalls, including a March 2020 recall due to incorrect tunneler tips, raising concerns about the device’s overall safety and reliability. Reports indicate that the device’s tubing, which delivers medication, can develop cracks over time, leading to bacterial contamination and the release of plastic fragments into the bloodstream.
As a result, patients like Randow face serious health risks, including abnormal heart rhythms, blood clots, vessel perforations, and other severe complications. Despite these known risks, allegations suggest that Bard failed to adequately warn patients and healthcare providers of these dangers, leading to preventable harm.
The lawsuit seeks compensation for Randow’s damages, including medical expenses, pain and suffering, and ongoing health monitoring. It also aims to hold Bard accountable for its alleged negligence and failure to prioritize patient safety.
Randow’s case underscores the importance of rigorous oversight and accountability in the medical device industry. Patients must be able to trust that the devices implanted in their bodies are safe and effective, and companies like Bard must be held accountable when they fail to meet these standards.
