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Product Liability

Bard PowerPort Lawsuit

Bard knew of design flaws and risks of its PowerPort implantable device yet chose to conceal these facts from the medical community and patients. Numerous reports show the device is prone to fracture and migrate, causing serious and life threatening injuries to patients. Lawsuits are being filed by individuals who had the Bard PowerPort implanted and were seriously injured when the PowerPort fractured or malfunctioned post-implantation.
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The Bard PowerPort

The Bard PowerPort is one of several varieties of port/catheter systems that has been designed, manufactured, marketed, and sold by Bard Access Systems, Inc. (a wholly owned subsidiary of Becton, Dickinson and Company (BD). The PowerPort is a totally implantable vascular access device designed to provide repeated access to the vascular system for the delivery of medication, intravenous fluids, parenteral nutrition solutions, and blood products.

The Bard PowerPort Implantable Port, colloquially known as the “PowerPort,” is a medical device crafted, distributed, and sold by an unnamed corporate group. The PowerPort belongs to a category of devices referred to as port/catheter systems. Designed to facilitate repeated access to a patient’s vascular system, it delivers medication, intravenous fluids, blood products, and parenteral nutrition solutions directly into the bloodstream. Surgically inserted beneath the skin, the PowerPort stays implanted within the patient.

Its structure comprises two main elements: an injection port and a polyurethane catheter. The injection port, characterized by a raised center or “septum,” serves as the area where the needle is inserted to deliver medication. From here, the medication travels through a flexible tube, the catheter, and enters the bloodstream.

The medication is carried from the port into the bloodstream through a small, flexible tube, called a catheter, that is inserted into a blood vessel. The PowerPort is used on patients who require repeated and prolonged access to the vascular system for IV administration of fluids or medication.

Chronoflex AL

The catheter part of the PowerPort is made from a polyurethane material called Chronoflex AL.  This material is a big point of contention in the Bard PowerPort lawsuits.  A growing number of lawsuits allege a  flaw in the chemical design and manufacturing for the Chronoflex catheters resulted in the PowerPort being weaker and less durable than it should have been. As a result of these inherent flaws, the PowerPort is prone to fracturing, migrating, and otherwise malfunctioning after being implanted.

The polyurethane in the catheter, known as Chronoflex AL, sourced from a biomaterials supplier named AdvanSourceBiomaterials Corporation, has been a topic of controversy. This catheter contains a mixture of polyurethane and barium sulfate, which increases its visibility in radiologic studies. Over time, the barium sulfate particles dissociate from the catheter’s surface, resulting in microfractures and other structural alterations that compromise the mechanical properties of the catheter.

Worse still, allegations have arisen that the manufacturer used an excessively high concentration of barium sulfate particles in the production process, leading to issues such as improper mixing and the formation of barium sulfate and air pockets throughout the catheter body. These manufacturing defects, it’s claimed, led to an irregular catheter surface riddled with fissures, pits, and cracks – a prime location for the accumulation and proliferation of harmful microbes or fungi, significantly escalating the risk of infection and sepsis.

Injuries Linked to the Defective PowerPort

The manufacturing and design problems with the Bard PowerPort make the implant highly susceptible to fracturing after being implanted. Fracturing of the port implant can often cause it to migrate and cause vascular damage. The PowerPort is also prone to a number of other malfunctions.

Fracture and migration of the PowerPort has led to a variety of very serious injuries including: hemorrhage; cardiac/pericardial tamponade (pressure caused by a collection of blood in the area around the heart); thromboembolism; infection; cardiac arrhythmia; severe and persistent pain; and perforations of tissue, vessels and organs, or the need for additional surgeries to remove the defective device. Many of these complications can even be life-threatening.

So the plaintiffs tend to fall in one of these categories:

Some of the more common injuries related to failure or malfunction of the Bard PowerPort implant are:

  • Infection: Situations where individuals have developed infections or sepsis as a result of using the Bard PowerPort device, which can lead to severe health consequences and require extensive medical treatment.
  • Catheter Fracture: Instances where the catheter of the Bard PowerPort device has broken or fractured, potentially causing serious health risks and complications. The PowerPort lawsuits alleged this is because the product was made so poorly.
  • Deep Vein Thrombosis: Instances where the use of the Bard PowerPort device has led to the formation of blood clots or deep vein thrombosis (DVT), posing a significant risk to the individual’s health and potentially requiring additional medical interventions.
  • Catheter Migration: Cases where the catheter of the device has moved from its intended position, leading to potential cardiac issues and other concerns requring treatment.
  • Vascular Damage:  Perforation of veins or other tissue by the PowerPort is also a concern.The fear is the device causes perforations or damage to blood vessels or surrounding tissues, resulting in complications and the need for further medical attention.

Bard Had Reason to Know About the Problems With the PowerPort

Soon after the PowerPort was introduced on the market, Bard began receiving large numbers of adverse event reports (“AERs”) from healthcare providers reporting that the PowerPort was fracturing post-implantation. Bard also received large numbers of AERs reporting that implant was found to have perforated internal vasculature.

As a result of these reports, Bard was aware or should have been aware that the PowerPort had a substantially higher failure rate than other similar products on the market. Bard should also have been aware that the problems with the PowerPort were related to flaws in the Chronoflex material used to make the device.

In March 2020, the FDA issued a class 2 recall for three models of the Bard PowerPort. The recall cited issues such as bloodstream infections, device displacement, catheter breakage, and thrombosis. Each patient reported distinct issues related to the PowerPort. (To be clear, there is no active recall for the Bard PowerPort.)

Failure to Warn

Soon after the PowerPort’s release, Defendants received numerous adverse event reports (AERs) about infections and internal perforations. These included severe injuries like hemorrhages, cardiac issues, pain, tissue perforations, and even deaths.

Bard Doubled Down

The PowerPort also had a higher failure rate than competitors, but the Defendants didn’t warn users. Bard PowerPort lawsuits allege that they hid the severity of PowerPort-related complications. So instead of improving the PowerPort or issuing warnings, the Defendants pushed forward, aggressively marketed it as safe despite knowing about its issues. As evidence stacked against them, the Defendants’ attempts at damage control seemed insincere and opportunistic. They launched a new product line, marketing it as an “enhanced” version, but skeptics quickly pointed out the similarities to the flawed PowerPort, understandably questioning if the so-called enhancements were genuine.

As a result, the lawsuits allege the defendants not only failed to warn but intentionally misled both patients and medical professionals about the safety of the PowerPort system.  They claim that the manufacturer knowingly put a dangerous product on the market without properly warning the users about potential risks. This alleged failure to inform users about the product’s issues is a central point in the current wave of lawsuits and an opportunity for plaintiffs to received punitive damages.

Complaints Continued

With each case, the legal complaints have become increasingly alarming. One of the chief allegations centers on the manufacturer’s apparent refusal to modify the PowerPort’s design to make it safer. Despite accumulating evidence of the device’s risks, the defendants are accused of prioritizing profit over patient safety, choosing to push a flawed product onto the market.

Critics argue that this neglectful attitude towards safety is not only unethical but also illegal.

Patients who underwent procedures with the PowerPort were often left in the dark about the device’s dangers. Without this critical knowledge, they were exposed to an increased risk of infection and sepsis as barium sulfate loss from the catheter’s surface continued, allegedly without any warning from the defendants.

Worse still, plaintiffs assert that the defendants, aware of the device’s flaws, did nothing to rectify the problem. Instead, they continued to actively and aggressively market the PowerPort as a safe device, despite their knowledge of numerous reports of thromboembolism and other severe injuries related to its use.

In the wake of these accusations, a string of lawsuits has emerged, arguing for the defendants’ culpability in causing patients unnecessary suffering. These patients were reportedly prescribed and implanted with PowerPorts, not knowing that the devices were, according to allegations, defective and prone to precipitating a host of life-threatening complications.

Bard’s Internal Documents Will Be Key

Documents have reportedly surfaced showing clear communication within Bard about PowerPort’s risks long before they became public knowledge. These documents may be proof of the Defendants’ deliberate disregard for the potential harm they were causing. If the magnitude of the deception was as profound as the Bard PowerPort lawsuits suggest, again, the potential of punitive damages could drive Bard PowerPort settlement amounts higher.

Bard PowerPort Lawsuits

Over the last few years, the defects in the PowerPort have led to a growing number of Bard PowerPort lawsuits. These lawsuits are being filed by individuals who had the Bard PowerPort implanted and were seriously injured when the PowerPort fractured or malfunctioned post-implantation.

The lawsuits are being filed against the manufacturer, Bard Access Systems Inc., and its parent company, Beckton Dickinson. The product liability lawsuits, that are now a class action lawsuit in Arizona that houses all federal cases against Bard, allege that Bard was aware of the problems with the device. They also allege that rather than alter the design of the PowerPort to make it safer or adequately warn of the dangers associated with the PowerPort, Bard continued to actively and aggressively market the device as safe, despite their knowledge of numerous reports of catheter fracture, infection and other serious injuries.

Moreover, the lawsuits claim that Bard’s warnings suggested that fracture of the device could only occur if the physician incorrectly placed the device such that “compression or pinch-off” was allowed to occur. In reality, however, Bard knew internally these devices were fracturing and causing serious injuries due to defects in the design, manufacturing and lack of adequate warnings. In other words, Bard tried to blame the flaws in the device on the doctors.

Gist of the Bard PowerPort Lawsuit Allegations

So, while there are a lot of ancillary claims, there are three main thrusts behind every Bard PowerPort lawsuit:

  1. Bard’s negligent failure to provide adequate warnings;
  2. Bard’s negligent design of the PowerPort; and
  3. strict liability based on a manufacturing defect.

Who is Eligible to File a Bard PowerPort Lawsuit?

Anyone who meets the following criteria may be eligible to file a Bard PowerPort lawsuit and seek financial compensation:

  • You had a Bard PowerPort device (or another Bard port/cath device) implanted
  • Your Bard PowerPort fractured, migrated, or otherwise malfunctions post-implantation
  • You suffered serious physical injuries as a direct result of the problems experienced with your PowerPort implant

Bard PowerPort Complications & Failures

The design flaws and manufacturing issues with the Bard PowerPort have made the device prone to 3 primary complications or post-implantation failures. These three primary complications are described below.

Fracture of the PowerPort

The most common failure or complication experienced with the Bard PowerPort is fracture of the port. The flaws with the material that the PowerPort is made from make it brittle. As a result, the tubing and other parts of the device are prone to fracture or break off and become lodged in the patient’s vascular system. Fracture of the PowerPort can lead to very serious injuries and vascular damage.

Migration of the PowerPort

The same design flaws that make the Bard PowerPort likely to fracture, also make the device prone to post-implantation migration (moving out of its original position). The migration usually involves the flexible tube parts that are inserted into the blood vessel. Migration can occur by itself or in combination with a fracture of the Bard PowerPort.

PowerPort Infection

The flawed nature of the material that the Bard PowerPort is made out of allow bacteria to enter when the material fractures or becomes degraded. As a result, infections originating at the site of the port are the third major complication associated with this device.

Contact Us About a Bard PowerPort Lawsuit

Our firm is currently accepting new cases from individuals who were injured by a defective Bard PowerPort implant. Contact us today at 800-551-8649 or by completing the form on this page.