Imagine that you just faced a major accident or illness that requires urgent hospitalization. But what if the medical device intended to support your treatment ends up hindering your recovery?
This is the unsettling reality for numerous patients who are being administered Bard PowerPort catheters. Designed to facilitate the administration of intravenous fluids, nutrients, and medicines into a patient’s bloodstream, the Bard PowerPort has unfortunately been prone to catheter fractures, device displacement, and other malfunctions, all carrying the potential for severe injuries.
Let’s delve into the complications associated with this medical device and explore the responses of the victims affected by it.
What is the Bard PowerPort Catheter Device?
The Bard PowerPort, also referred to as the “BardPort,” is a port catheter device inserted just under the skin to facilitate easy connection to a catheter for the intravenous delivery of medication or fluids.
Introduced in 2000 after securing FDA approval, the Bard PowerPort seemed like a straightforward yet groundbreaking device that was swiftly embraced by medical facilities globally to enhance long-term patient care. Unfortunately, at the time of adoption, both patients and doctors were unaware that this seemingly life-saving device could potentially pose life-threatening consequences.
Bard PowerPort Manufacturing Defects
Since its introduction, a considerable number of individuals have reported issues with the Bard PowerPort, such as instances where the catheter port material cracked, leading to catheter fracture or migration.
The PowerPort catheter utilizes barium sulfate to enhance its visibility under X-rays. This radiographic contrast agent, however, poses a risk of damaging the catheter by causing leaks.
Despite manufacturers incorporating barium sulfate into the catheter’s silicone or polyurethane, the particles of the chemicals do not fully integrate into the catheter polymer, leaving them unattached.
As the bendable catheter accommodates a patient’s movement by stretching and bending, the catheter’s surface undergoes mechanical stress.
Leaking barium sulfate particles may result in cracks, notches, and holes in the catheter’s surface. According to TorHoerman Law, these manufacturing defects could potentially lead to various injuries, including hemorrhage, sepsis, cardiac punctures, thromboembolism, blood infection, and more.
Regrettably, Bard was aware of the escalating complications caused by this design flaw but took no corrective action, and as of now, they have not issued a recall for the PowerPort device.
Bard PowerPort Lawsuit Claims Device Caused Life-Threatening Injuries
A fractured catheter can result in significant internal damage as the catheter pieces circulate in the bloodstream. Emergency surgery is often necessary in all cases to remove any broken pieces and treat affected organs, if any.
Complications may stem from a catheter infection, potentially leading to bloodstream infection, swelling, tenderness, and soreness at the PowerPort site, as well as vascular damage.
Pinch-off syndrome poses another grave complication that occurs when the catheter is squeezed between the clavicle and the rib. This compression can cause the medicine or fluids to get blocked in the catheter, which may cause the device to fracture.
A study published by the National Library of Medicine examined device failures and fractures of totally implantable central venous access systems, sampling over 3,000 devices. In this study, Bard products constituted the largest segment of defective devices.
The Bard PowerPort lawsuit claims that the life-threatening design defects of the port and the associated risk of catheter complications were not adequately revealed to patients.
FDA’s Bard PowerPort Recall
In March 2020, the U.S. Food and Drug Administration initiated a Class 2 recall for three Bard PowerPort models, pointing to concerns like bloodstream infections, device displacement, catheter breakage, and thrombosis. Each patient presented unique problems associated with the PowerPort. However, this recall was officially concluded in May 2022.
As of today, Bard Access Systems Inc., the manufacturer of Bard PowerPort, persists in marketing the products as safe and effective without implementing a recall, making adjustments to the product, or incorporating additional warnings on the label.
Did Bard Access Systems Know of the PowerPort Design Defects?
In the majority of Bard PowerPort injury lawsuits, victims argue that Bard was aware of higher rates of PowerPort catheter fractures, migrations, and infections compared to similar products in the market but neglected to take action for an extended period.
As these legal cases unfold, the allegations have grown more troubling. A significant claim revolves around the manufacturer’s purported reluctance to enhance the PowerPort’s design for increased safety. Despite mounting evidence highlighting the device’s risks, the company is accused of prioritizing financial gains over patient safety, opting to introduce a flawed product to the market.
In Conclusion
The pursuit of justice continues for those harmed by the Bard PowerPort Device, as individuals injured are actively engaging in legal proceedings. As of August 2023, all Bard PowerPort claims have been consolidated into a multidistrict litigation (MDL).
Currently, a class action lawsuit against Bard is underway, accusing the company of promoting a faulty device without implementing essential modifications or offering sufficient warnings. Only time will tell how this medical tragedy unfolds in the days ahead.