The Bard PowerPort catheter device is now the focus of several product liability lawsuits after many patients have reported severe injuries related to the product's inherent defects. The Bard PowerPort or BardPort as it is also known, is a family of catheter devices that are designed to allow the intravenous delivery of fluids and medication to patients.
Several Bard PowerPort lawsuits filed against Becton Dickinson & Company, and its C.R. Bard and Bard Access Systems, Inc. subsidiaries claim that plaintiffs suffered injuries such as infections and deep vein thrombosis because the PowerPort fractured or migrated out of position.
Dolman Law Group is now accepting new clients that have been injured because of complications related to Bard PowerPort defects. Those with injuries related to Bard PowerPort failures may be eligible to seek compensation for the damages related to their injuries by filing their own Bard PowerPort lawsuit. Contact the offices of Dolman Law Group now to schedule a free no-obligation consultation with our Bard Powerport lawyers to find out how our firm can help you seek compensation and hold Bard Access Systems, Inc. accountable.
What is Bard PowerPort?
The Bard PowerPort is a group of medical devices that are designed, manufactured, and sold by Bard Access Systems, Inc which is a subsidiary of Becton, Dickinson and Company (BD). The FDA first approved the Bard PowerPort in 2000 meaning these devices have seen use for over two whole decades. There are multiple devices in this family of products such as the Bard PowerPort ClearVue Implantable Port and several generations of the Bard PowerPort Implantable Port that have seen widespread usage.
These devices are what are known as port/ catheter systems that allow medical professionals to access a patient’s vascular system (circulatory system) via an implantable polyurethane catheter tube that is inserted into a vein or other part of the vascular system.
On the end of the catheter tube that is on the outside of the body is a round injection port surgically implanted into the skin that doctors and other medical professionals can deliver medication, blood products, intravenous fluids, and parenteral nutrition solutions through via a raised self-sealing silicone “septum” at the center. The PowerPort can also be used to withdraw blood samples as well.
The Bard PowerPort is surgically implanted into patients beneath the skin and remains in them so that repeated and convenient delivery of the aforementioned medication and such is possible.
Bard PowerPort Defects
Conceptually, the Bard PowerPort is an appealing medical device for doctors that treat patients with repeated need for vascular system access. The problem is that the Bard PowerPort Implantable Port has been reported to have severe issues with the materials used in its construction that have resulted in harmful failures.
The main issue lies with the catheter tube of the PowerPort which is made of a polyurethane material known as Chronoflex AL sourced from a biomaterials supplier named AdvanSourceBiomaterials Corporation based in Wilmington, Massachusetts. Several Bard PowerPort lawsuits allege that the Chronoflex AL polyurethane used in the construction of PowerPort catheter tubes is defective due to a flaw in its chemical design and manufacturing.
Barium Sulfate Defects in PowePort Catheter Tubing
The catheter tubing is composed of a mixture of polyurethane which is a family of polymer plastics and barium sulfate which is a compound (also known as BaSO4) that is a radiocontrast agent for x-ray imaging. Barium sulfate is what is known as radiopaque contrast media which means that it is seen clearly in an x-ray.
The barium sulfate in PowerPort catheter tubing allegedly dissociates from the surface of the tubing and causes the structure to fracture and change in a way that compromises the device. Bard PowerPort lawsuits claim that the manufacturing of the catheter tubing utilized too high a concentration of barium sulfate which resulted in numerous issues.
Since the concentration of barium sulfate was too high, the mixture of it and polyurethane would be too thick before being formed into the catheter tubing during the polymerization process. As a result, the spread of barium sulfate throughout the tubing would be uneven and create pockets of the compound and air that weaken the tubing and lead to fissures, microfractures, pitting, cracks, and other irregularities that lead to a number of failure scenarios.
Bard PowerPort Device Complications and Failures
These defects in Bard PowPowerPorts have had serious repercussions among patients the devices have been implanted in since the devices themselves are invasive in nature and the patients that typically require their use are usually in a vulnerable medical state to begin with. Despite these problems with the PowerPort, it has still not been recalled as of the writing of this page.
The following are some common examples of Bard PowerPort failures reported by patients.
PowerPort Fractures, Fissures, and Cracks
One of the most commonly reported issues with the Bard PowerPort is the development of fractures and other dangerous imperfections on the surface of the device’s tubing that is inserted into the body. Due to the brittle and weak nature of the catheter tubing allegedly due to manufacturing and design defects, the small imperfections in the tubing can compromise the integrity of the device and even lead to pieces of it breaking off and flowing into the patient’s vascular system to cause severe health complications.
The same issues with Bard PowerPort catheter tube brittleness can also lead to the device moving over time from a safe position. The migration of PowerPort tubing because of these defects can be responsible for several health problems.
PowerPort Proliferation of Microbes and Other Pathogens
The use of medical devices that are placed directly into a patient’s body always comes with a degree of risk of infection. The Bard PowerPort’s defects can increase the risk of infections due to defects creating imperfections in the tubing where pathogens like bacteria can develop and proliferate.
Bard PowerPort Injuries
The following injuries can potentially be caused by the failure or structural compromise of a Bard PowerPort device
- Deep Vein Thrombosis
- Vascular Damage (tearing or puncture of blood vessels)
- Cardiac arrhythmia
- Cardiac Punctures
- Pulmonary embolism
- Organ Damage
- Cardiac or Pericardial tamponade
- Heart attack or myocardial infarction
- Hematoma or hemorrhage
- Hemothorax (collection of blood between chest wall and lung)
- Pneumothorax (collapsed lung)
- Pulmonary pseudoaneurysm
Bard Knew About PowerPort Defects and Injury Risk
The problems with Bard PowerPort devices did not come out of left field and in fact, have been reported for some time. After the PowerPort was put on the market, Bard Access Systems, Inc. began receiving adverse event reports (“AERs”) from healthcare providers that claimed the medical devices were fracturing and causing injuries after they were implanted in patients. These AERs were submitted at higher rates than those of similar products indicating a problem.
The Concealment of Reports on Bard PowerPort Malfunctions
Bard has been accused of attempting to conceal these problems by taking advantage of the reporting exemptions the PowePort had since it was issued clearance under the special §510(k) provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act.
Normally, medical products must undergo extensive FDA vetting before being put on the market but the Bard PowerPort was issued clearance under the aforementioned §510(k) provision which allows for the marketing of medical devices if the manufacturer can show that it is substantially equivalent to other previously approved devices. Manufacturers granted this kind of approval may also be excluded from normal adverse event reporting requirements.
This meant that Bard was able to avoid having to file their AERs through the FDA’s Alternative Summary Reporting (ASR) program and keep them out of the public eye. After the FDA released over 6 million sealed AERs after significant outcry over the ASR program’s obscurity of these problems, the full scope of PowerPort’s issues became more clear.
Bard Access Systems, Inc. Failure to Address Known PowerPort Defects
The existence of a significant number of AERs going back to the 2000s indicates that Bard Access Systems, Inc. and Becton Dickinson & Company had knowledge that there were problems with their product that increased risks for patients. Instead of taking steps to address these problems, recall the product, or at least inform patients receiving these devices of the risks of injury the defendants in the new Bard PowerPort lawsuits instead continued to aggressively market their product to unknowing healthcare providers and patients.
In addition to this, Bard would attempt to shift blame for PowerPort malfunctions onto doctors by claiming that a fracture or “pinch off” of the PowerPort tubing would only be possible if the device was incorrectly implanted.
Many people could have avoided severe injuries and complications related to the PowerPort had they known of the risks caused by defects that Bard neglected to address in favor of profit. This negligence is the basis of the Bard PowerPort lawsuits now being filed.
Filing a Bard PowerPort Lawsuit
Thousands of people are potentially eligible to file a product liability lawsuit against Bard Access Systems Inc., and its parent company, Beckton Dickinson because of injuries and damages suffered due to PowerPort defects. Consumers have a right to expect that they will be informed of the health risks associated with the products they consume and that the products are as safe as their designers and manufacturers can facilitate.
Bard Access Systems Inc., C.R. Bard, and their parent company, Beckton Dickinson not only failed to address defects in Bard PowerPort devices they were aware of but they also failed to inform consumers of the risks they faced using them and therefore deprived consumers of making an informed choice. It is because of this that these companies are considered liable for the damages patients have suffered as a result of PowerPort-related injuries.
Patients injured by Bard PowerPort malfunctions can face severe damages in the form of medical bills, lost wages, and pain and suffering that can drastically reduce their quality of life. A Bard PowerPort lawsuit can not only hold Bard accountable for prioritizing profit over patient safety but also seek compensation for these damages in order to make the plaintiff whole again.
Why Choose Dolman Law Group as Your Bard PowerPort Lawyers
Dolman Law Group is an award-winning and nationally recognized law firm with over 100 years of experience shared between our team of product liability attorneys. The 2023 edition of Best Lawyers will feature Dolman Law Group Accident Injury Lawyers, PA. Only 6% of practicing attorneys in the United States can claim this honor.
Selecting Dolman Law Group as your legal representation in a Bard PowerPort lawsuit means you will have the support of a personal injury firm with a name defendants will respect. The product liability lawyers of Dolman Law endeavor to not only advise and negotiate on their client’s behalf but work with them closely to ensure that their case is handled with a real investment in the outcome. This has not only given Dolman Law an excellent history of successful case results but ensured our clients are satisfied with our assistance as indicated by their testimonials.
With Dolman Law Group representing your Bard PowerPort case you not only have the benefit of legal insight honed by years of successful litigation but also the resources to even the playing field with major medical companies like Becton Dickinson & Company. Dolman Law can assist you in
- Determining whether or not you have a case
- Calculating your damages
- Investigating your case and gathering evidence
- Negotiation of a fair settlement
- Representation in trial
- Preparing and sending demand letters
Contact Dolman Law Group For Help With Your Bard PowerPort Lawsuit
If you or a loved one have suffered any of the aforementioned injuries because of your Bard PowerPort device then do not hesitate to contact Dolman Law Group about your case. The Bard PowerPort lawyers of Dolman Law are accepting new clients that have had the Bard PowerPort device used in their treatment and suffered complications related to its defects.
Our firm offers free no-obligation consultations to those considering taking legal action after suffering Bard PowerPort injuries and is ready to meet with you and discuss what can be done to get you compensation for your damages.