Medical device manufacturer Bard faces mounting litigation over serious complications associated with its PowerPort implantable catheter devices. As of February 2025, more than 1,000 cases are pending in federal court, with initial bellwether trials expected to begin later this year.
Our law firm is actively reviewing claims involving:
- Catheter fractures and migrations through blood vessels
- Life-threatening blood clots and infections
- Cardiac complications requiring intervention
- Device failures necessitating surgical removal
The federal judiciary has consolidated these cases into Multi-District Litigation to efficiently handle the growing number of claims. If you or a family member experienced complications from a Bard PowerPort device, you may be eligible to pursue compensation through this litigation.
PowerPort Device Complications
The Bard PowerPort litigation involves several documented device complications that have led to serious patient harm. Court records show that PowerPort failures often manifest as catheter fractures, where pieces of the device break off and migrate through blood vessels. These fragments can cause severe damage, requiring emergency medical intervention and device removal.
Other significant complications documented in the litigation include deep vein thrombosis, where dangerous blood clots form around the catheter, and tissue erosion, where the device damages surrounding blood vessels and tissue. Many patients have experienced chronic infections requiring removal of the device, while others report complete port failure that prevents proper medication delivery.
A particularly concerning issue is Pinch-Off Syndrome, where the catheter becomes compressed between the collarbone and first rib. This compression can lead to device malfunction and potential fracture of the catheter.
Device failures may require additional surgeries, extended hospitalization, and ongoing medical treatment. These complications often result in significant medical expenses, lost wages, and other damages that may be compensable through legal action.
If you experienced complications after receiving a PowerPort implant, maintain thorough documentation of your medical treatment and contact our legal team to discuss your options for pursuing compensation through the current litigation.
MDL Litigation Status February 2025
Arizona MDL 3081 Overview
The Bard PowerPort™ lawsuits are consolidated in a multi-district litigation in Arizona federal court (IN RE: Bard Implanted Port Catheter Products Liability Litigation, MDL No. 3081), where Judge David G. Campbell is overseeing coordinated proceedings.
As of early February 2025, the litigation includes over 1,000 active cases and continues to grow. Recent court developments have strengthened plaintiffs’ positions, with Becton Dickinson accepting shared financial responsibility for settlements and the Court establishing clear timelines for resolution by 2026.
Scheduled Court Deadlines
- April 7, 2025: Deadline for parties to submit proposed bellwether cases
- April 14, 2025: Final deadline for resolving any disputes over case selection
- Late 2025 – Early 2026: Expected start of first bellwether trials
Scope of the Litigation
The potential scale of this litigation is substantial, with approximately 300,000 Bard PowerPort devices implanted in patients nationwide. A parallel MDL involving AngioDynamics Port Catheters includes an additional 90 lawsuits. The selection of six bellwether cases, now extended to April 7, 2025, will be important in determining the strength of plaintiffs’ claims and potential settlement values.
Judge Campbell has expressed his intent to resolve the litigation by 2026, establishing an efficient timeline for case resolution. The bellwether trials, set to begin in late 2025, will test liability theories and help establish compensation frameworks for the broader group of cases. This timeline shows momentum toward resolution for affected patients.
PowerPort Device Background
Bard’s PowerPort is an injection port, port-a-catheter or “port-a-cath” which are implantable vascular access devices designed to provide repeated access to the vascular system for the delivery of medication, intravenous fluids, parenteral nutrition solutions, and blood products.
Also, some implantable ports, like Bard’s PowerPort, are “power-injectable” which lets medical providers inject contrast dyes into the port to perform contrast CT scans and MRIs.
The PowerPort is about the size of a quarter and surgically placed under the skin and has a catheter that is inserted into one of the body’s large central veins in the upper chest or neck area (usually the upper vena cava, jugular vein, or subclavian vein).
Surgically implantable ports are typically preferred over Peripherally Inserted Central Catheter (PICC) lines when the patient needs delivery of medications, fluids, or blood products over longer periods (many months or years). PICC lines, which are typically placed into one of the large veins in the arm using local anesthetic, are preferable for shorter term use and can be left in place for weeks or a few months.
Because Bard’s PowerPort devices allow high injection rates of contrast agents used in CT and MRI scans, these devices are often implanted in cancer patients to receive chemotherapy.
Bard’s first PowerPort device was cleared by the FDA in 2000 via the controversial 510(k) process. Unlike the more rigorous Pre-Market Approval (PMA) process, which requires the manufacturer to provide significant data showing the medical device is safe and efficacious before approval by the FDA, the 510(k) process does not require the medical device manufacturer to show safety or efficacy.
For a medical device to be “cleared” by the FDA for marketing under 510(k), the manufacturer need only show the device is substantially similar to a device already on the market. Additional PowerPort devices were cleared for marketing under the 510(k) process in 2006, 2007, 2008, 2009, 2012, 2014 and 2019.
There are several implantable ports and catheters sold under Bard’s PowerPort brand including:
- Bard Groshong MRI implantable injection PowerPort
- Groshong Central Venous Catheter
- Bard PowerPort MRI Implantable Port
PowerPort ID Card and Bracelet
Because any medical provider must know whether a patient has an implantable injection port in their body, patients who receive Bard PowerPort devices receive a PowerPort ID Card. The ID Card, given to the patient by the implanting doctor, has important information about the patient’s PowerPort device including the manufacturer’s name, device name, device model, serial number, lot number and date of implantation.
Some recipients may also receive a rubber PowerPort bracelet with different colors identifying the specific port device the patient received. A medical provider must know exactly what port device was implanted because different ports have different pressure rates for fluid intake.
Complications with the PowerPort devices
The PowerPort devices were designed to use catheters made of a polymeric mixture of polyurethane and barium sulfate called “Chronoflex AL.” Barium sulfate is known to adversely affect the mechanical integrity of polyurethane in vivo by dissociating from the catheter’s surface, leaving microfractures and other changes which degrade the polyurethane catheter’s integrity.
The lawsuits allege Bard’s manufacturing process involves using too high a concentration of barium sulfate leading to structural changes and degradation of the catheter’s surface. Over time, these areas of degradation and structural weakness can cause the catheter to fracture or allow for the accumulation of bacteria causing infection.
FDA Adverse Event Reporting History
The true risks associated with the Bard PowerPort were concealed from patients and doctors for years due to Bard’s use of a loophole in the FDA’s adverse event reporting requirements.
The FDA has an exemption process that lets certain medical device manufacturers report adverse events associated with their products in a non-public database instead of the publicly accessible, Manufacturer and User Facility Device Experience (MAUDE). This exemption process, which was launched in 2000, let medical device manufacturers hide millions of adverse event reports from public view.
Essentially, manufacturers who were granted this reporting exemption filed “summary reports” into the FDA’s internal, non-public database instead of individual reports for each adverse event into the public MAUDE database.
This registry exemption was created by the FDA with no public notice or regulations. Ironically, it resulted from the FDA being inundated with AER reports in the late 1990s, after the under-reporting of adverse events led to criminal charges against medical device companies.
To reduce the agency’s workload, the FDA let device manufacturers seek exemption from reporting individual adverse events to the public MAUDE database and instead, to file a summary report which included a spreadsheet of injury or malfunctions quarterly, bi-annually, or yearly.
The breadth of the secret adverse event database was exposed in an investigative report by Kaiser Health titled “Hidden FDA Reports Detail Harm Caused by Scores of Medical Devices.”
Although any deaths associated with a medical device must still be reported in MAUDE, Kaiser found many “serious injury and malfunction reports for about 100 medical devices,” which included surgical staplers, mechanical breathing machines, balloon pumps for blood vessels and Bard’s PowerPort devices.
An FDA official told Kaiser Health that the program is supposed to be for issues that are “well-known and well-documented with the FDA.” However, Kaiser’s review found this hidden, “voluntary summary reporting program was put in place for up to 5,600 [medical] devices.”
Bard could use the FDA’s hidden, summary reporting database for the PowerPort by claiming that any injuries associated with the device were due to “compression or pinch-off events” which Bard said were “known-risks” associated with the PowerPort and resulted from error by the implanting doctor and not due to any design defect. Blaming doctors let Bard continue to file safety reports into the secret, non-public database and to categorize these events as injuries due to doctor error rather than a malfunction of the device.
Due to immense public pressure after Kaiser Health’s investigative report revealed the existence and breadth of the FDA’s secret AER database, the FDA announced it was ending the Alternative Summary Reporting Program and released more than 5.7 million adverse events filed under the Program to the public.
After the FDA released the millions of adverse event reports hidden from the public, it was discovered these reports included many involving complications from the Bard PowerPort. With the public now aware of the extent of the risks of complications associated with the Bard PowerPort, several product injury lawsuits were filed.
Manufacturer Liability Issues
Lawsuits allege that Bard knew the PowerPort was defectively designed which was contributing to serious and potentially life-threatening injuries associated with the PowerPort. These injuries often resulted from catheter fragments breaking away and migrating through the vascular system, potentially causing catastrophic harm.
Rather than addressing the dangerous design defect, lawsuits claim that Bard tried to shift the blame for the problems onto implanting doctors, issuing warnings that indicated if a doctor implants the device incorrectly it could cause a “compression or pinch-off” event.
Current Legal Claims Overview
The primary claims in the PowerPort lawsuits are those often seen in other medical device-based product liability lawsuits such as strict liability failure to warn and design defect, negligent failure to warn, negligent design, breach of express and implied warranties, misrepresentations, concealment of material facts and violation of various state consumer protection laws.
Generally, the theme underlying all these claims is the defendants knew of the injuries caused by the PowerPort device but did not warn patients and doctors of these risks. Largely, the lawsuits allege the problems associated with the PowerPort were concealed from patients and doctors by the FDA’s hidden, secret adverse event report database.
The defendants in the PowerPort lawsuits are Bard Access Systems, Inc., C.R. Bard, Inc., and Becton Dickinson and Company. Bard Access Systems, a Utah corporation, is the entity responsible for developing, designing manufacturing and distribution the PowerPort. Bard Access Systems is a subsidiary of C.R. Bard, Inc. which is incorporated and has its principal place of business in New Jersey. In 2017, Becton Dickinson acquired C.R. Bard and Bard Access Systems, both of which are wholly-owned subsidiaries of Becton Dickinson. These are the primary defendants, but other defendants may be proper depending on the specific facts of the case and which state law applies.
Legal Consultation
Our medical device litigation team represents patients affected by PowerPort complications across the country through Multi-District Litigation No. 3081. If you experienced device migration, fracture, infection, blood clots, or other serious complications requiring medical intervention, we can evaluate your potential claim.
Time limits apply to these cases, so prompt action is important. Our experienced attorneys will review your medical records to determine your eligibility and explain your options clearly. We handle PowerPort cases on a contingent fee basis, which means we advance all litigation costs and only collect legal fees when we secure compensation for you.
Please complete our secure case evaluation form below to discuss your PowerPort case with our team. We’ll respond promptly to answer your questions and explain how we can help.