The Bard PowerPort is an implanted port catheter designed to facilitate the intravenous delivery of fluids or medications. However, inherent design and manufacturing flaws have led to serious injuries such as vascular damage. As a result, individuals who have experienced harm from these defects are now filing lawsuits against the manufacturer, seeking accountability and compensation for their injuries.

What is a Bard PowerPort?

The Bard PowerPort is a port catheter device designed to simplify medication administration and blood withdrawal. Commonly used for chemotherapy, antibiotic therapy, and routine blood draws, the device offers a minimally invasive alternative to repeated needle sticks. The Bard PowerPort consists of an injection port implanted subdermally, typically in the arm or chest, which is connected to a polyurethane catheter inserted into one of the large central veins leading to the heart.

What is the Bard PowerPort lawsuit?

Although the Bard PowerPort was developed to improve patient care, multiple reports of malfunctions and injuries have emerged. The Bard PowerPort lawsuits make several significant allegations against the device manufacturer, Bard Access Systems (a subsidiary of Becton, Dickinson & Company), including defective design, failure to warn, and negligence. The rapid increase in lawsuits has led to the consolidation of cases into an MDL in the U.S. District Court for the District of Arizona under Judge David G. Campbell.

Notably, Bard’s first PowerPort device was FDA-cleared in 1999 through the controversial 510(k) process, which required only proof of similarity to existing devices, not safety or efficacy. By bypassing clinical trials and the burden of proof of safety measures, device manufacturers were able to significantly shorten the approval timeline, allowing them to bring products to market more quickly and start generating profits sooner.

What injuries have been linked to Bard PowerPort?

Multiple reports of injuries have emerged, especially those related to internal vascular damage:

  • Infections: Patients have reported infections at both the implant site and in the bloodstream, requiring device removal and aggressive antibiotic treatments.
  • Blood Clots: Blood clots forming around the device have been reported, leading to complications including deep vein thrombosis (DVT). A DVT occurs when a blood clot forms in a deep vein, with the risk that the clot moves to the lungs, leading to a pulmonary embolism.
  • Pulmonary Embolism: A PE is a potentially life-threatening injury that occurs when a blood clot suddenly blocks a lung artery. This can happen when a blood clot breaks loose and travels through the bloodstream to the lungs. A pulmonary can be fatal and requires immediate treatment.
  • Vascular Damage: Injury to blood vessels can compromise blood flow and cause several complications, including clotting and tissue death.
  • Severe Pain: Intense and persistent pain can occur as a result of catheter detachment, often requiring comprehensive pain management interventions.
  • Organ Puncture: A catheter fracture can release small fragments that travel through the bloodstream, potentially puncturing vital organs such as the lungs or heart. This can lead to serious complications, including internal bleeding, organ damage, and other life-threatening conditions.
  • Cardiac Tamponade: This condition is caused by fluid accumulation around the heart, which creates pressure that prevents the heart from properly pumping blood. If not treated promptly, it can lead to organ failure, shock, or death.

Plaintiffs in the lawsuits allege that Bard engaged in failure to warn by not adequately disclosing the risks of injuries. They argue that Bard failed to fulfill its legal obligation to warn users about known or foreseeable dangers, leaving them unable to make informed decisions about using the device or considering alternatives from competitors.

What defects have been associated with Bard PowerPort?

Bard PowerPorts have been linked to significant design flaws, particularly involving the material used in the catheter tubing. The catheters are made from a polyurethane-based material called Chronoflex AL, which combines polyurethane with barium sulfate. This combination, intended to create a semi-flexible tube suitable for insertion into blood vessels, has instead raised safety concerns due to its tendency to deteriorate and fail over time.

  • Catheter Fracture or Breakage: The polyurethane tubing can become brittle, causing fractures that allow catheter fragments to detach and migrate through the bloodstream. These foreign objects pose serious risks, including life-threatening embolisms or cardiac tamponade.
  • Device Migration: The structural degradation of the catheter can cause it to shift from its original location, leading to pain and often requiring surgical intervention to reposition or remove the device.
  • Port Malfunction: As the catheter material deteriorates, pits can form along its surface, creating areas where bacteria can accumulate. This increases the risk of infection, potentially compromising treatments and leading to systemic health issues.

The presence of barium sulfate in the tubing makes the catheter visible on X-rays but also contributes to the device’s instability. Plaintiffs in the Bard PowerPort lawsuits argue that improper ratios of barium sulfate within the Chronoflex AL material weaken the catheter’s structural integrity. When the mixture is imbalanced, the tubing becomes prone to failure, increasing the likelihood of fractures, migration, and infection. These defects serve as the basis for ongoing lawsuits, with plaintiffs alleging that the use of excessive barium sulfate caused serious medical complications.

What are the latest updates on the Bard PowerPort lawsuit?

October 2024: Legal Progress and Major Case Consolidation
On October 3, the court held a hearing to review the progress of evidence collection. Both sides debated whether the defendants properly withheld or redacted certain documents, claiming legal privileges. There was also discussion about whether the discovery timeline should be extended because the defendants delayed handing over documents and repeatedly postponed witness depositions. The judge requested additional briefings on these issues. Additionally, the court addressed disputes over the materials used in the defendants’ catheters. The judge ruled that if the plaintiffs later discover the defendants intentionally withheld information, they could return to court to seek penalties.

In a similar lawsuit, on October 7, an MDL panel consolidated all AngioDynamics port catheter lawsuits in the Southern District of California. This move centralizes over 50 lawsuits, with plaintiffs alleging that AngioDynamics’ port catheters are defective and pose severe health risks, similar to the claims made in the Bard PowerPort litigation. The court’s decision to consolidate the cases aims to streamline pretrial proceedings and ensure more efficient handling of these complex product liability claims.

September 2024: Record Surge in New Cases and Growing Scrutiny
September marked a significant increase in case filings, with nearly 100 new lawsuits added to the Bard PowerPort MDL, bringing the total number of active cases to 427. This surge represented the largest to date, reflecting the growing momentum of the litigation. In mid-September, a California plaintiff joined the MDL, alleging that her PowerPort implant from 2021 caused an infection and pericardial effusion—an accumulation of fluid around the heart that can become life-threatening.

These developments underscore the increasing scrutiny of Bard’s port devices as plaintiffs across the country continue to report severe health complications. The rapid growth in filings suggests that the litigation may still be in its early stages, with thousands more potential cases under investigation.

August 2024: 9th Case Management Conference and Expanding Litigation
On August 6, the court signaled that a bellwether trial date could be set soon, likely for 2025. This trial will play a pivotal role in shaping the outcomes of the litigation. Additionally, a Tennessee plaintiff filed a new complaint, claiming his Bard M.R.I. Implantable Port caused both an infection and vein thrombosis, marking it as a potentially high-value case.

On August 20, the court held its 9th Case Management Conference, addressing non-compliant plaintiffs and successor liability claims against BD. The session highlighted the court’s intention to push discovery forward efficiently, with the next conference scheduled for October 3. Toward the end of the month, a Missouri plaintiff joined the MDL, alleging thrombosis caused by her PowerPort implant from 2012.

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