What Problems Can A Defective Bard Power Port Cause?

What Problems Can A Defective Bard Power Port Cause?

Every year, thousands of medical devices are implanted to improve lives—but not all devices perform as promised. The Bard PowerPort, a commonly used implantable port for delivering medications like chemotherapy, has come under scrutiny for allegedly causing severe complications. Reports of infections, device fractures, and even life-threatening injuries linked to the PowerPort have raised concerns for patients relying on its safety.

If you’ve experienced unexpected complications following a Bard PowerPort implantation, you’re not alone—and you may have legal options. At Lawsuits.com, our network of attorneys is ready to help you understand your rights. 

Call (888) 984-6195 today and we will connect you with a local lawyer who will guide you through your next steps.

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What is the Bard PowerPort?

The Bard PowerPort is a medical device designed to make long-term treatments more manageable. Implanted just under the skin, it acts as a gateway for administering medications, drawing blood, or delivering other therapies directly into a vein.

This device is particularly common among patients undergoing chemotherapy, those with chronic illnesses, or individuals requiring frequent intravenous access. The promise of convenience and reduced pain has made it a popular choice in hospitals and clinics across the United States.

How the Bard PowerPort Works

The device consists of two main components:

• Port Reservoir: A small, round chamber made of metal or plastic implanted under the skin, typically in the chest area. This chamber is covered with a silicone membrane that allows healthcare providers to insert a needle multiple times without damaging the device.
• Catheter: A flexible tube attached to the port, which connects to a vein, often the superior vena cava, ensuring direct and reliable access to the bloodstream.

Once in place, the device eliminates the need for repeated needle sticks and vein searches, providing a streamlined way to deliver treatments and monitor a patient’s health. For patients undergoing long-term therapy, the benefits are undeniable—when the device functions as intended.

Potential Defects in Bard PowerPort Devices

Despite its intended purpose, the Bard PowerPort has faced allegations of serious safety risks. Reports from patients and healthcare providers suggest that some devices may have serious defects. 

These defects fall into two primary categories: design flaws and manufacturing defects.

Design Flaws: When the Blueprint Goes Wrong

Allegations against the Bard PowerPort suggest that certain design elements may predispose it to failure. For example:

• Material Selection Issues: The catheter is made from Chronoflex AL, a specialized polyurethane mixed with barium sulfate. This material choice has led to unintended consequences:
  • The barium sulfate particles can detach from the catheter over time, weakening its structural integrity.

When a design flaw exists, the problem isn’t isolated to a single device—it may impact every unit produced, placing countless patients at risk.

Manufacturing Defects: Errors in Execution

Even with a solid design, poor manufacturing practices can introduce dangerous flaws. Manufacturing defects occur when deviations from the approved production process compromise the device’s safety or effectiveness. In the case of the Bard PowerPort, these defects may include:

• Improper Mixing: Lawsuits have alleged that the polymer components are not mixed proportionately, leading to:
  • Pockets of barium sulfate and entrapped air distributed throughout the device.
  • Increased vulnerability to cracks, fissures, and fractures.
• Quality Control Issues: There are suggestions of inadequate quality control during the manufacturing process, leading to inconsistent product quality.

Medical Complications Arising from Defective Bard PowerPorts

A defective Bard PowerPort can lead to a range of serious medical complications. These can be life-altering, requiring extensive medical intervention and causing prolonged suffering.

Common Complications Linked to Defective PowerPorts

1. Catheter Fractures
   • What Happens: The catheter connected to the port may crack or break, releasing fragments into the bloodstream. These fragments can travel to areas such as the lungs or heart, leading to embolisms or other internal damage.
   • Impact: Patients often require emergency surgery to remove the fragments, and the risk of permanent injury is high.
2. Infections
   • What Happens: Defective materials or improper manufacturing practices can make the device susceptible to bacterial colonization. Infections may occur at the implantation site or spread throughout the body, leading to sepsis.
   • Impact: Systemic infections can be life-threatening, requiring hospitalization and aggressive treatment.
3. Thrombosis (Blood Clots)
   • What Happens: The defective design of the device may encourage blood clot formation around the port or catheter, blocking veins or arteries.
   • Impact: Thrombosis can cause severe swelling, pain, and restricted blood flow. In some cases, clots can dislodge and travel to the lungs, resulting in a potentially fatal pulmonary embolism.
4. Device Migration
   • What Happens: The PowerPort may shift from its intended position, potentially damaging surrounding tissues or organs.
   • Impact: Migration can cause intense pain and may necessitate surgical repositioning or removal of the device.

Legal Implications of Defective Bard PowerPorts

Patients harmed by these devices may pursue claims under product liability laws, aiming to hold manufacturers accountable for defects and inadequate warnings.

Product Liability Claims

Product liability law allows individuals injured by defective products to seek compensation. In the context of defective Bard PowerPorts, potential claims include:

Strict Liability: Accountability Without Exception

Strict liability laws place the responsibility for product defects squarely on the shoulders of the manufacturer, regardless of whether they acted negligently. Under this legal standard, a plaintiff does not need to prove that Bard acted carelessly; instead, they must show:

• The PowerPort had a defect (design, manufacturing, or inadequate warnings).
• The defect existed when the device left the manufacturer’s control.
• The defect directly caused the patient’s injuries.

Strict liability laws vary by state, but most follow principles rooted in the Restatement (Second) of Torts § 402A, which outlines liability for unreasonably dangerous products.

Negligence: Proving a Breach of Duty

Unlike strict liability, negligence claims require plaintiffs to prove that the manufacturer failed to meet a reasonable standard of care in designing, manufacturing, or warning about the product. This could involve:

• Design Negligence: Demonstrating that Bard used a flawed design that posed unnecessary risks to patients, such as selecting materials prone to fractures or degradation.
• Manufacturing Negligence: Highlighting errors in the production process, such as insufficient quality control measures, that resulted in defective units.
• Failure to Warn: Showing that Bard did not adequately disclose known risks or provide clear instructions for the safe use of the PowerPort.

Many states, including Texas, require proof that the manufacturer’s actions directly caused the injury and that the harm was foreseeable—a critical element in negligence claims.

Breach of Warranty: Broken Promises

Warranties, whether explicit or implied, create expectations about a product’s safety and functionality. When a device like the Bard PowerPort fails to meet these standards, patients may file claims for:

• Breach of Express Warranty: Arguing that Bard made specific promises about the device’s safety or performance that were proven false.
• Breach of Implied Warranty of Merchantability: Asserting that the device was not fit for its ordinary use, violating the expectations established under the Uniform Commercial Code (UCC § 2-314) adopted by most states.

Notable Lawsuits and Settlements

Several lawsuits have been filed against Bard concerning the PowerPort device. For instance, in August 2023, a breast cancer patient sued over a defective Bard PowerPort, alleging that the device's faulty design led to severe complications.

As of this article’s publication date, no major settlements have been publicly disclosed. However, our network of law firms are actively accepting Bard PowerPort cases, and lawyers expect many more people to file.

Regulatory Response

No Comprehensive Recall

Despite the reported issues, there has not been a comprehensive recall of Bard PowerPort devices related to the potential catheter risks that are the subject of the lawsuits.

Class 2 Recall in 2020

The FDA did post a Class 2 recall notice for several models of the Bard PowerPort in March 2020. However, this recall was for a separate issue unrelated to the main concerns raised in the lawsuits.

Urgent Medical Device Recall Notification

In September 2019, the Health Sciences Authority issued an urgent medical device recall notification. This recall was related to an incorrect barb tip for the included catheter in the PowerPort, which could potentially cause the catheter to become dislodged from the tunneler

Regulatory Oversight Concerns

Alternative Summary Reporting Program

Lawsuits allege that Becton Dickinson (BD), the parent company of Bard, may have used the FDA's Alternative Summary Reporting (ASR) program to conceal thousands of adverse event reports:

• This program, permitted under 21 CFR 803.19, allowed manufacturers to submit certain device malfunction reports in summary form to the FDA. The use of this program potentially allowed Bard to hide the true extent of device failures from doctors and patients.

Lax Oversight Claims

Some allegations in the lawsuits suggest that regulators enabled the problems with lax oversight. While there have been some limited recalls for specific issues, there does not appear to have been substantial regulatory action taken against Bard PowerPort devices in response to the broader safety concerns raised in the ongoing lawsuits, with most of the action occurring in the legal arena rather than through regulatory channels.

Patient Rights and Legal Recourse

Medical device manufacturers have a legal obligation to ensure their products are safe for use and to provide adequate warnings about potential risks. When they fail to meet these standards, patients may pursue compensation for their injuries and related losses.

Identifying Symptoms of Device Failure

If you suspect your Bard PowerPort is defective, it’s important to recognize potential signs of failure. Symptoms to watch for include:

• Infection: Redness, swelling, warmth, or discharge at the implantation site, fever, or general malaise may indicate an infection.
• Thrombosis: Pain, swelling, or discoloration near the port could point to a blood clot.
• Device Migration or Fracture: Unexplained pain, difficulty using the port, or imaging results showing displaced or broken components.

Steps to Take if You Are Affected

1. Seek Immediate Medical Attention: If you experience symptoms of a defective device, consult your healthcare provider promptly. Your safety and well-being should always come first. This will also create an official medical record, which will serve as evidence if you choose to proceed with a lawsuit.
2. Request Medical Records: Obtain detailed records of your PowerPort implantation, any complications, and subsequent treatments.
3. Consult a Lawyer: Reach out to our team at Lawsuits.com, and we will connect you to a local attorney in our network experienced in medical device litigation. They will evaluate your case and explain your legal options.

Filing a Lawsuit Against Bard

Patients harmed by defective PowerPorts may file lawsuits under product liability laws. These claims typically aim to recover compensation for:

• Medical Expenses: Including additional surgeries, hospital stays, and treatments.
• Lost Wages: For time missed from work due to health complications.
• Pain and Suffering: Accounting for the physical and emotional toll of the injury.

Under laws like the California Product Liability Act or equivalent statutes in other states, plaintiffs must demonstrate that a defect in the PowerPort directly caused their injuries. This can involve showing evidence of design flaws, manufacturing errors, or inadequate warnings.

Timely Action Matters

Every state imposes a statute of limitations for product liability claims, which dictates how long you have to file a lawsuit after experiencing harm. For instance, in California, this period is generally two years from the date of injury (Cal. Code Civ. Proc. § 335.1). Acting quickly ensures your claim remains valid and strengthens your case.

Secure Justice for Your Bard PowerPort Injuries

Medical devices like the Bard PowerPort are meant to make life easier, not harder. When these products fail, you deserve justice.

If you or a loved one has been harmed by a defective Bard PowerPort, don’t wait to act. Call (888) 984-6195 today. 

At Lawsuits.com, our network of lawyers is ready to connect you with a local attorney who will fight for your rights and work to ensure you receive the justice and compensation you deserve.