Bard PowerPort Failure Lawsuits
Bard PowerPort Failure lawsuits are being filed against Bard alleging that the implantable intravenous ports have serious design defects that cause the devices to break apart and migrate, leading to catastrophic life-threatening injuries, including infections, and blood clots among other injuries. The FDA approved the first Bard PowerPort device in 2000.
What is the Bard PowerPort device?
The Bard PowerPort is a specific brand and type of implantable port device, which is commonly used in medical treatments requiring frequent access to the venous system for the delivery of medications, chemotherapy, blood products, and for the withdrawal of blood samples. The Bard PowerPort is manufactured by C.R. Bard, Inc. (now part of Becton, Dickinson and Company).
These ports are small, medical devices that are implanted under the skin, typically in the upper chest area. They consist of a port body through which drugs can be injected and a catheter that connects the port to a vein. The PowerPort is designed to be easily accessible for healthcare providers, allowing for repeated access to the venous system without the need for multiple needle sticks.
The PowerPort devices are used in patients who require long-term intravenous treatments, such as those undergoing chemotherapy, long-term antibiotic therapy, or intravenous feeding.
A growing number of patients are now reporting severe injuries and are filing lawsuits claiming that Bard PowerPort complications could have been avoided if Bard had adequately disclosed the risks linked with the devices.
Complications seen with the Bard PowerPort Failure
Some patients who were implanted with an implantable PowerPort developed the following complications:
- Severe Infection: One of the most common complications of any implanted device, including the Bard PowerPort, is infection. Infections can develop for various reasons, including polyurethane catheter fractures, migrations, bacteria entering the body when the device fractures or degrades, design flaws that make the PowerPort prone to fractures. This can occur at the site of implantation or internally, along the catheter. Infections can require antibiotics or, in severe cases, removal of the port.
- Deep Vein Thrombosis DVT: The presence of a foreign body within a vein can increase the risk of blood clot formation. The arms, legs, and pelvis are at higher risk of developing DVT due to the Bard PowerPort device’s implantation location. If a clot forms in the vein used by the port, it can block blood flow, leading to swelling and pain, and may require treatment with blood thinners or removal of the port. Or the blood clot can migrate causing a brain embolism or pulmonary embolism.
- Catheter Occlusion: The catheter can become blocked or occluded, preventing medications from being administered or blood from being withdrawn. Occlusions can be caused by blood clots, drug precipitation, or a kink in the catheter.
- Catheter Migration, Fracture or Dislodgement: The catheter can move from its original position, which might affect its functionality or cause complications including fractures. In some cases, this may require surgical intervention to reposition or replace the catheter.
- Perforations of blood vessels and organs: Patients might experience hemorrhage, tearing of major blood vessels or organs including the heart leading to cardiac tamponade and death.
Bard PowerPort Federal Lawsuits
The JPML issued an order on August 8, 2023, transferring all Bard Port lawsuits to the U.S. District for the District of Arizona, where the claims will be assigned to Judge David G. Campbell for coordinated discovery and pretrial proceedings, including bellwether trials of a few selected injury cases to determine the evidence and jury response to the plaintiffs and defendants.
As of February 2024, there are 99 active lawsuits pending in Arizona multidistrict litigation (MDL) 3081.
Each of the Bard PowerPort lawsuits will be individual-based. Judge David G. Campbell, oversaw the Bard IVC filter lawsuit MDL, which was established in August 2015 and included more than 8,000 claims.
What is the cause of Bard PowerPort Failure?
According to lawsuit allegations, the Bard PowerPort catheter tubes are made of a defective material that is susceptible to fissuring, cracking and fracturing. The catheter tubing is made of a flexible polyurethane polymer called Chronoflex, which is a mixture of polyurethane and barium sulfate.
According to experts, the Bard PowerPort has high concentrations of barium sulfate, causing the polyurethane’s mechanical integrity to break, resulting in microfractures, tube breakdown, fissuring, and cracking.
It is alleged that deficiencies during the manufacturing process resulted in pockets of barium sulfate and entrapped air being distributed through the catheter body and surfaces. Surface degradation of the tubes may also increase the risk of thromboembolism or blood clots.
Barium sulfate plays a critical role in the design and functionality of Bard PowerPort devices. It is used as a radiopaque agent, meaning it is designed to be visible under X-ray imaging. When incorporated into the port’s material, barium sulfate allows healthcare providers to easily locate and confirm the position of the port within the body using X-ray imaging. This visibility is crucial for ensuring the port is correctly placed during the implantation procedure and for guiding needle insertion during the port’s use for medication administration or blood withdrawal.
Studies Highlight PowerPort Blood Clot and Fracture Risks
According to one study published in the Journal of Biomedical Materials Research found that barium sulfate particles do not mix well with polymer catheters. The authors stated this failure to integrate can lead to the development of rough spots on the catheter surface, which can lead to blood clots.
Bard PowerPort Failures Were Known for Years
As alleged in many Bard PowerPort failure lawsuits, plaintiffs claim that Bard knew PowerPort catheter fractures, migrations, and infections were being reported at higher rates than other similar products on the market, yet neglected to act for years.
Bard Access Systems Inc., C.R. Bard, Inc. and Becton Dickson & Company are now exposed to lawsuits noting that inadequate warnings were provided about the PowerPort problems for the doctors and the companies failed to perform adequate post-marketing surveillance to identify reports of injury and death.
The plaintiffs are adamant that severe and catastrophic injuries could have been avoided if a safer alternative design had been used. Medical researchers have suggested that a polyurethane coating could help prevent these problems and protect patients from injuries.
According to the plaintiffs rather than making these changes, the manufacturers hid their knowledge about issues with the Bard catheters and continued to actively advertise the PowerPort device as safe.
Injured by Bard Power Port device? Contact Dr. Shezad Malik Law Firm
If you or a loved one was implanted with a Bard PowerPort device and have suffered serious infection, blood vessel injuries, blood clots or embolism problems including organ perforation, contact the attorneys at Dr. Shezad Malik Law Firm to learn more about your legal rights. You can speak with one of our representatives by calling 214-390-3189, or by filling out the case evaluation form on this page.
Our law firm’s principal office is in Dallas and we have offices in Fort Worth, Texas. Dr Shezad Malik Law Firm represents clients in dangerous drug and dangerous medical device lawsuits nationwide.