Bard Power Port Class Action Lawsuit

Recall Details and Affected Products

The Bard PowerPort, cleared by the FDA in 2012 as a Class II device, consists of a subcutaneous injection port connected to a polyurethane catheter made from ChronoFlex AL, a polymer blend with barium sulfate for X-ray visibility. Implanted under the skin in the chest or arm, it facilitates repeated vascular access without peripheral IVs. Affected models include:

PowerPort ClearVue: Single-lumen port for standard infusions.
PowerPort isp MRI: MRI-compatible version with enhanced imaging features.
SlimPort and Dual-Lumen Variants: Compact or multi-catheter designs for complex therapies.

Distributed nationwide through hospitals and surgical centers since 2012, the device costs $1,000–$3,000 per implantation. No formal recall has been issued, but the FDA’s MAUDE database logs thousands of adverse events, including 1,500+ fractures reported by 2025. The MDL, overseen by Judge David G. Campbell, consolidates federal claims; state filings continue separately. As of November 2025, 2,127 cases pend in the MDL, up from 1,807 in September, with new short-form complaints joining weekly. Plaintiffs must prove implantation and subsequent complications via medical records. BD maintains the device is safe but faces scrutiny for allegedly concealing failure rates exceeding 10% in internal studies.

This crisis mirrors the 2010 Bard vena cava filter MDL, which settled for $4 billion after 5,000+ suits over migrations and perforations, underscoring patterns in BD’s vascular products.

Health Risks of Bard Power Port Failures

The PowerPort’s vulnerabilities arise from barium sulfate leaching, creating micro-cracks that propagate under bodily stresses like blood flow or infusions:

Catheter Fracture: Tubing snaps internally, releasing fragments that embolize to lungs, heart, or brain, triggering pulmonary infarcts or strokes.
Device Migration: Dislodged ports erode veins or pierce organs, causing hematomas or cardiac tamponade.
Infections and Thrombosis: Breaches invite bacterial ingress, leading to sepsis; clots form around debris, risking deep vein thrombosis or emboli.

Cancer patients and those on long-term TPN are most endangered, with the FDA warning of 20–30% revision rates in high-use cases. The American Society of Clinical Oncology reports vascular access failures contribute to 15% of chemotherapy complications, amplifying morbidity in already compromised individuals [2].

Symptoms of Bard Power Port Complications

Manifestations often emerge months post-implantation, mimicking other ailments:

Early Symptoms: Localized pain or swelling at the port site, fever spikes, or infusion resistance signaling infection or partial occlusion.
Vascular Effects: Shortness of breath, leg swelling from DVT, or chest pain from emboli blocking pulmonary arteries.
Severe Signs: Sudden hypotension, hemoptysis, or neurological deficits like confusion from cerebral fragments; cardiac arrhythmias or tamponade demand immediate intervention.
Systemic Fallout: Sepsis-induced multi-organ failure, with survivors facing chronic pain, PTSD, or lifelong anticoagulation therapy.

Diagnostic imaging like CT venography confirms issues; untreated fractures can lead to fatal perforations. Treatment burdens average $50,000–$200,000 per case, encompassing explant surgeries, ICU stays, and rehab.

Potential for a Bard Power Port Class Action Lawsuit

Though structured as an MDL rather than a traditional class action, the Bard Power Port Class Action Lawsuit framework allows coordinated pursuit of justice for thousands, with bellwether outcomes likely dictating global resolutions. Central allegations posit:

1. - Design Defect: ChronoFlex AL’s incompatibility with physiological environments, violating FDA premarket expectations under 21 CFR 820.
  - Failure to Warn: Omission of degradation risks in labeling, despite internal data showing 5–15% failure rates by year three.
  - Negligent Manufacturing: Inconsistent quality control at BD facilities, leading to particulate contamination.
  - Fraudulent Marketing: Promotions as “durable for 1,000+ punctures” despite known vulnerabilities, breaching consumer protection statutes.

Compensation tiers vary: $10,000–$50,000 for minor infections; $50,000–$100,000 for DVT revisions; $100,000–$1M+ for fractures with emboli, plus punitives up to 3x damages. The MDL’s 2,000+ dockets evoke the $1.6B Bard filter settlements; first trials (e.g., Cook infection case, March 2026) could yield $2M–$10M verdicts, pressuring BD toward a $500M–$2B fund. A landmark Bard Power Port Class Action Lawsuit victory might mandate material reforms, post-market surveillance, and patient registries, revolutionizing implantable device accountability in the $50B vascular access market.

Do I Have a Bard Power Port Class Action Lawsuit?

The Class Action Litigation Group at our law firm is an experienced team of trial lawyers focusing on medical device lawsuits. We are handling individual litigation nationwide and currently accepting new PowerPort injury cases in all 50 states.

Free Bard Power Port Class Action Lawsuit Evaluation: If you or a loved one suffered complications from a Bard PowerPort implantation, you should contact our law firm immediately. You may be entitled to compensation by filing a Bard Power Port Class Action Lawsuit, and our lawyers can help.

References

1. https://www.torhoermanlaw.com/bard-powerport-lawsuit/
2. https://www.asco.org/practice-patients/guidelines
3. https://www.lawsuit-information-center.com/bard-powerport-lawsuit.html