Port Catheter Infection Lawsuits Over Bard PowerPort Devices Claim Faulty Design Promotes Colonization of Bacteria

It has been more than one year since a federal multidistrict litigation (MDL) was established to handle all Bard PowerPort lawsuits filed over infections, fractures and migration injuries, and there are now hundreds of claims presenting similar allegations that the implantable port catheter system has dangerous design defects that were not adequately disclosed by the manufacturer.

The Bard PowerPort was approved by the FDA in 2000, and is widely used by individuals undergoing chemotherapy or other treatments. The device was designed by Bard Access Systems Inc., featuring an injection port for needle insertion and a polyurethane catheter tube that transports medications into the right internal jugular or subclavian vein.

Unlike other implanted port catheters, the Bard PowerPort devices are marketed as a high-pressure port, which are designed to withstand the increased pressure required for certain types of injections, such as contrast injections in CT scans. However, the lawsuits indicate that some patients have suffered severe injuries when the Bard PowerPort fractured or caused an infection to develop.

According to a docket entry (PDF) issued this month by the U.S. Judicial Panel on Multidistrict Litigation, there are currently at least 427 product liability lawsuits filed against Bard in the federal court system, each raising nearly identical allegations that the materials used to allow the device to withstand high pressure injections can actually cause the port catheter to degrade and develop fissures, cracks and pits.

This not only increases the risk of the Bard PowerPort fracturing or breaking, but many of the lawsuits indicate that this promotes the colonization of bacteria, resulting in:

• Catheter-Related Bloodstream Infections (CRBSI)
• Candida
• Endocarditis
• Escherichia coli
• Fungal Infections
• Klebsiella
• Staphylococcal Infections
• Sepsis/Septic Shock
• Other Infections

In this featured post, Aboutlawsuits.com will outline some of the common allegations in these Bard PowerPort infection lawsuits, which explain how the implantable port catheters caused individuals to develop dangerous and life-threatening injuries.

What Causes PowerPort Infections?

Many of the lawsuits filed to date claim the defective Bard PowerPort device can increase the risk of infection due to the catheter and port reservoir designs, which can fail and allow bacteria to accumulate and grow, leading to bloodstream infections, sepsis and other serious health issues.

Bard PowerPort Catheter Infection Risks

Bard PowerPort lawsuits claim that the deterioration of barium sulfate and entrapped air in the catheters can create fissures, cracks and pits where bacteria can accumulate and build up, leading to blood clots and bloodstream infections.

These PowerPort devices use a catheter made of a material known as Chronoflex, which is a mixture of polyurethane and barium sulfate that is visible during certain radiologic studies.

However, this same barium sulfate formulation allowing the PowerPort implantable ports to be visible during scans can cause pockets of the chemical and entrapped air to build up throughout the catheter body and surface, weakening the structural integrity of the catheter. These pockets of barium sulfate and air can break down over time causing catheter fractures, fissures and cracks.

Bard PowerPort lawsuits claim these irregular surfaces and pits allow bacteria to accumulate and grow, leading to bloodstream infections, sepsis and other serious health issues.

The fractures and cracks that develop in the catheters can also increase the risk of blood clots, which can significantly elevate the risk of developing deep vein thrombosis, along with more critical issues such as pulmonary embolism and organ damage.

Lawsuits further claim these clots not only reduce blood flow, creating stagnant zones that facilitate bacterial proliferation but also damage blood vessel walls, providing additional pathways for bacteria to enter the bloodstream.

Bard PowerPort Reservoir Design Increases Infection Risks

While the majority of Bard Powerport lawsuits filed in the multidistrict litigation have pointed to catheter defects, individuals also claim the PowerPort’s reservoir is made of a vulnerable material that can fail and promote colonization of bacteria.

In a Bard PowerPort wrongful death lawsuit filed by Rena Wood late last year on behalf of her deceased sister’s estate, Wood claims a defective Bard PowerPort reservoir caused her sisters death after developing sepsis. Wood’s complaint states that her sister, passed away on March 1, 2022, and the death certificate listed severe sepsis with septic shock and infected left subclavian port as causes of her death.

In the complaint, Wood states the Bard PowerPort reservoirs are made from polyoxymethylene (POM), an acetal thermoplastic polymer that is a lower-cost alternative to other materials such as titanium. This POM material is known to undergo oxidative degradation, a process that can occur both during the manufacturing process and when the material is exposed to radiography (X-rays).

Wood claims the roughened catheter surface leads to the collection and proliferation of fibrinous blood products, thereby drastically increasing the risk of biofilm, infection, and the development of sepsis.

Which PowerPort Models Are at Risk of Infection?

All Bard PowerPort models designed to be used with ChronoFlex catheters or ports made from POM material may increase the risk of infection, according to allegations raised in the lawsuits. Among the models of the Bard port catheter systems that may use these materials are:

• Bard PowerPort
• Bard Powerflow™
• Bard SlimPort
• Bard X‑Port™
• Bard MRI Ports
• Bard Groshong Catheter
• Bard Titanium Port
• Bard Vaccess CT

Study Links PowerPort Catheter Designs to Increased Infection Risks

In each of the Bard PowerPort lawsuits filed, individuals claim that safer port catheter designs were available that could have prevented PowerPort degradation and infection injuries.

PowerPort lawsuits have pointed to research dating back to 2010 stating the use of surface modifying additives (SMA) to coat the catheters can significantly prevent catheter fractures and accumulation of bacteria.

In a 2010, Nephrology Dialysis Transplantation study, researchers compared uncoated catheters made with barium sulfate mixtures to those coated with a surface-modifying additive (SMA) designed to prevent barium sulfate particle release and surface degradation.

Using in vivo (patient-based) and in vitro (lab-based) tests, the study evaluated the resistance of both catheter types to blood and bacterial exposure, focusing on Staphylococcus epidermidis.

Surface Integrity Problems

The study found uncoated catheters that used barium sulfate, such as the PowerPort catheters, showed a significant detachment of barium sulfate particles leading to surface irregularities.

In contrast, modified catheters did not exhibit degradation due to the protective SMA coating, according to the study findings.

Bacterial Growth Problems

The uncoated catheters showed a marked increase in bacterial growth upon exposure to Staphylococcus epidermidis, highlighting their susceptibility to infections. The SMA-coated catheters, however, demonstrated a significant reduction in bacterial adhesion and proliferation.

“Short-term exposure of conventional catheters to the bloodstream causes BaSO4 particle release, resulting in surface irregularities predisposing to bacterial proliferation,” stated researchers in this study.

These findings directly link uncoated Bard PowerPort catheters using barium sulfate to higher infection risks, reinforcing the basis for lawsuits against the manufacturer. Plaintiffs argue that the company could have avoided these risks by adopting safer designs to prevent particle release, fracturing, migration and subsequent infections.

Despite these concerns that have been highlighted in medical research since 2010, no Bard PowerPort recall over fracture, migration or infection risks has been issued to date.

PowerPort Infection Injuries Reported to the FDA

PowerPort lawsuits present allegations that Bard concealed PowerPort infection, fracture and migration risks dating back to the early 2000’s. The lawsuits suggest that the manufacturer hid hundreds, if not thousands, of PowerPort failure and injury reports from doctors and patients by taking advantage of the U.S. Food and Drug Administration’s (FDA) Alternative Summary Reporting (ASR) program.

It was not until 2019, when the FDA ended the special reporting exemption under the ASR program, which has since allowed problems with PowerPort to become public knowledge.

According to the FDA’s Manufacturer and User Facility Device Experience (MAUDE), between 2018 and June 2023, more than 500 reports of Bard PowerPort device failures and catheter failures resulting in serious injuries or deaths have been reported by physicians and patients.

In many of these incidents involving PowerPort infections, patients were required to undergo additional surgeries to replace the implantable venous access system following a catheter fracture or migration.

Types of Bard PowerPort Catheter Infections and Symptoms

While PowerPort and other TIVAD medical devices have been advertised to have lower infection rates, a fractured catheter can promote the growth of bacteria, which can enter the bloodstream or surrounding tissues.

PowerPort Infection Side Effects

As a result of these types of bloodstream infections that can causes serious injuries and disruptions to medical treatments, individuals are filing lawsuits seeking compensation for other side effects caused by the infections, including;

Thrombosis: Catheter-related infections can lead to thrombosis or blood clot formation, obstructing the flow of blood and potentially leading to pulmonary embolism if the clot travels to the lungs.

Catheter Malfunction: Infections can cause blockages or malfunction of the catheter, requiring emergency surgery to remove or replace the device.

Antibiotic Resistance: Many infections necessitate the use of antibiotics, potentially leading to antibiotic resistance. This resistance can make future infections harder to treat.

How do I know if my port catheter is infected?

Infection in a Bard PowerPort or any other central venous port can manifest in various ways. Some common signs of infection include:

• Redness, swelling or tenderness around the port site
• Warmth or heat around the port site
• Drainage or pus coming from the port site
• Increased pain or discomfort around the port site
• Fever or chills
• Fatigue or general malaise
• Unexplained weight loss
• Red streaks extending from the port site

It’s important to note that these symptoms can vary, and not all implanted port device infections present with the same signs. Additionally, some port-related infections might not display any noticeable signs at an early stage. If you experience any concerning symptoms or suspect an infection, it is important to notify your healthcare providers immediately.

How to File a Bard PowerPort Lawsuit

If you or a loved one were injured by a Bard PowerPort medical device, submit information about your potential claim for review by a Port catheter lawyer to determine whether a settlement or lawsuit payout may be available.

AboutLawsuits.com has partnered with law firms to provide free claim evaluations, by completing a short on-line questionnaire that will be reviewed by a lawyer to determine if a settlement or lawsuit payout may be available.

Claim evaluations are free and all cases are handled by lawyers on a contingency fee basis, which means that there are no fees or expenses unless a recovery is obtained.