Port a Cath Complications
The Bard PowerPort™ lawsuits allege that individuals were injured after their port catheter fractured or pinched-off allowing pieces of the catheter to migrate into the patient’s vena cava. This can lead to serious and potentially life-threatening injuries such as infections and sepsis, blood clots, perforation of vessels, organs and tissue, pulmonary embolisms, cardiac punctures, cardiac tamponade, and bleeding.
June 12, 2024 Update
The Bard PowerPort lawsuits are part of a multi-district litigation in Arizona federal court titled IN RE: Bard Implanted Port Catheter Products Liability Litigation, MDL No. 3081. Judge David G. Campbell of the U.S. District Court in Arizona is overseeing the litigation and has stated his intent to resolve the litigation by 2026.
On April 5, 2024, all cases eligible for the bellwether pool (test cases for trial) were submitted to the Court. Six bellwether cases will be selected for trial in 2025. Discovery is ongoing.
The Bard PowerPort Implantable Medical Device
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.
Additionally, 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
The Bard 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 that has 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 Bard’s PowerPort Devices
The Bard 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.
PowerPort Risks Exposed by New FDA Reporting Guidelines
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 were able to file “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 consisted of 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 physicians 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.
Bard Blamed Doctors for PowerPort Fractures and Migrations
Lawsuits allege that Bard knew the PowerPort was defectively designed which was contributing to serious and potentially life-threatening injuries associated with the PowerPort. Most injuries were due to pinch-off or fracturing events which lets fragments of the catheter tubing break away and migrate into the patient’s vena cava where it can cause catastrophic injuries.
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.
The devices can fracture, compress, pinch off or migrate causing injuries such as:
- Infections
- Blood Clots
- Perforations of Organs, Vessels and Tissue
- Catheter Fractures
- Pulmonary Embolisms
- Cardiac Punctures
- Cardiac/pericardial tamponade
- Cardiac Arrythmia
- Tearing of blood vessels
- Infections and sepsis
- Hemorrhage
- Wrongful Death
Legal Claims in the PowerPort Lawsuits
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 use of 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.
If you, or a loved one were injured by a Bard PowerPort medical device, contact us today for a free case and medical record review. We are evaluating cases throughout the United States and all cases are handled on a contingency fee basis. This means there are no out-of-pocket costs to you for our firm to review your case and represent you in a PowerPort lawsuit.
To find out if you or a loved one qualify for a Bard PowerPort lawsuit, click on the button below for a free case and medical record review.