A catheter is an indispensable medical device that has been in use since the early 1900s. In reality, catheters are 3,500 years old but the ones used in modern medical science only date back a little over a century.
It is typically a thin, flexible tube that is inserted into a duct or body cavity for easy transfer of fluids. These devices may be used to administer medications into the patient’s body. Conversely, some variants are useful in draining urine and other fluids out of the body.
According to the American Cancer Society, three types of transfusion catheters are available today – central venous catheters, midline catheters, and peripheral IV catheters. Bard Access Systems Inc. is a leading manufacturer of such catheters for blood transfusions, hemodialysis, chemotherapy, and other treatments. However, the company’s devices are failing to meet its self-established standards.
In this article, we will discuss the dwindling reputation of Bard in detail, especially in the context of its power port catheter.
The Company’s History
In case someone is unaware of Bard Access Systems Inc., they will surely know C.R. Bard, founded in 1907. The former serves as a manufacturing division for the latter, a medical technology company that manufactures and distributes diagnostic and surgical care devices.
It is important to remember that the division was made only in 1990. After starting operations in Rhode Island, the company continued to grow in Salt Lake City having acquired a small enterprise there.
With its first medical patent published in 1987, the company successfully acquired 183 more to date. Since its conception and growth, Bard Access Systems Inc. has gained much market footing. Its first-ever catheter device, the Foley catheter, was introduced in 1934.
In the 1960s, Bard acquired a company that specialized in manufacturing intravenous heart catheters. The next decade was all about acquiring 10 more companies that allowed Bard to produce surgical and cardiology equipment.
In the 1980s, the company had to recall the former heart catheters due to defects. By the early 2000s, Bard had stopped dealing with these catheters altogether. In 2000, the company manufactured the Bard PowerPort, a catheter system that received Food and Drug Administration (FDA) approval.
The Bard PowerPort was an implantable medical catheter comprising two components. The first was a tiny port catheter that goes under the skin. The second was a tube that provides easy access to the patient’s vascular system. Soon enough, this device became extremely popular in the medical industry for offering long-term access to the patient’s bloodstream.
Bard Dragged into a Legal Battle
It appears that Bard’s fame was meant to be short-lived. Healthcare providers and patients complained that the catheter devices were defective, failing to meet the basic safety standards.
According to TorHoerman Law, the device had fractured and lodged into patients’ vascular systems. The most common injuries associated with this included severe infections, pulmonary embolism, cardiac punctures, and myocardial infarction, among others.
The injured patients have filed the Bard PowerPort lawsuit against the manufacturer, with the first case dating to early 2023. Besides the injuries, the plaintiffs alleged that the device manufacturer knew about the design defect during clinical trials. However, everyone was kept in the dark including healthcare providers.
It is believed that the FDA was aware of the issues with the device. In 2020, the agency even issued a Class II recall for three of the models that caused severe infections and thrombosis. This type of recall is issued for medical devices that carry a low death risk but could still lead to serious adverse events.
Litigation Progress and Settlements
As of now, no Bard Power Port lawsuit settlement amount has been given. Given the first filing date, the Bard PowerPort lawsuit is currently in its early stages. Over the course of a year, the litigation has grown rather slowly. Until now, 300,000+ power ports by the manufacturer have been installed nationwide. This gives Bard Access Systems Inc. a whopping 70% market share.
Compared to the number of devices used for patients, the litigation has witnessed only 154 filings. Does it mean that a vast majority of Bard PowerPorts have no defects? In light of the FDA warnings and recalls, the plaintiff’s counsel believes it to be a case of snail-pace progression. As awareness about the litigation grows, it is expected that more lawsuits will pour in.
If such speculations are true, the Bard PowerPort litigation will also become a mass tort. However, the only concern right now is the dilemma regarding the progress. Hopefully, things will soon gather enough momentum for pretrial discovery and Bellwether trials.