About the Bard PowerPort™ Lawsuit

Lawsuits against the manufacturers of Bard PowerPort™ allege that the companies jeopardized consumers’ safety by marketing, producing, and selling defective devices. Countless patients have experienced serious injuries and infections from the implantable Bard PowerPorts™, and now these individuals are filing lawsuits to hold the manufacturers accountable.

Bard and its subsidiaries produce nearly 90% of implantable catheter devices on the market, and an alarming number of these fail. In 2022, the National Institutes of Health reported that nearly five million port-a-cath systems are implanted in U.S. adults annually. An FDA report suggests that the five-year complication rate of Bard PowerPorts™ is nearing 60%. If 25 million devices—the majority produced by Bard—are implanted over 5 years, 15 million are potentially defective. Bard has not issued warnings or a recall to protect consumers, despite the growing number of injuries resulting from these defective devices.

The volume of possible claims against this company is one reason the Bard PowerPort™ lawsuit will be handled as a multidistrict litigation (MDL). These legal proceedings streamline discovery and pretrial phases without sacrificing the merit of each individual case. Though this lawsuit is centralized in the U.S. District Court of Arizona, claimants may also choose to file their claim in other jurisdictions.

If you’ve experienced a serious injury or infection due to a defective Bard PowerPort™, Bell Legal Group is here to help you understand the details about this defective product lawsuit to protect yourself and loved ones from negligent manufacturers.

How a Bard PowerPort™ Works

A Bard PowerPort™ is an implantable catheter placed in a small chamber under a person’s skin. This provides a central line for healthcare providers to administer chemotherapy, therapeutic drugs, and fluids via injection or infusion. A Bard PowerPort™ is a convenient, discreet implantable solution for frequent intravenous therapy, but when these medical devices fail, they cause severe injuries and infections, and in some cases, death.

What Happens When a Bard PowerPort™ Fails

Injuries from defective Bard PowerPorts™ can be devastating because the implantable ports are proximate to a person’s bloodstream. When these catheters fissure or crack, they can cause serious blood infections, and when parts of the devices fail, pieces can break off and cause thrombosis or lacerate arteries or tissues.

Why Is Bard Being Sued for Its PowerPort™ Devices?

The complaints in the Bard PowerPort™ lawsuit allege the manufacturer knew the devices were defective and likely to cause significant injuries and infections, but the company continued to market and sell these implantable ports as safe medical devices.

Bard’s Safety Shortcuts and Fast-Tracked Port Approvals

Bard PowerPort™ manufacturers submitted their 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) which is a process that allows ‘substantially equivalent’ products to be brought to market, essentially piggy-backing off a similar device. This does not mean medical device manufacturers like Bard are exempt from testing or monitoring their goods. It simply expedites the approval.

In its PowerPort™ approval response letters, the FDA stated that, “You may, therefore, market the device, subject to the General Controls of the Act.” General Controls are the basic authorities of the Medical Device Amendments that provide the FDA with the means of regulating devices to ensure their safety and effectiveness. “The General Controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.”

However, Bard used the FDA’s approval to market their ‘substantially equivalent’ devices to bypass rigorous safety testing. This first of such approvals was granted over 15 years ago and these types of implantable port catheters not only remain on the market, but Bard also continues to dominate the market with devices that cause harm to countless individuals.

How Bard’s Failures Caused Consumers Harm

Medical device companies are responsible for manufacturing products according to industry regulations. When used as directed, these devices should not cause people harm. When adverse events occur, the manufacturer should alert consumers. Bard had responsibility in doing so, yet ignored the General Controls outlined in its approval and allowed its devices to remain on the market—unimproved—and failed to notify consumers and healthcare professionals about the failures associated with the device.

Improper Manufacturing Practices

The FDA’s approval mandated that Bard follow ‘good manufacturing practices’ in accordance with its federal regulations. These requirements include design controls and checks and balances to make sure a device’s design is safe, free of defects during the manufacturing process, and appropriate for the intended use. Bard’s PowerPort™ construction includes the use of Chronoflex AL—a polyurethane material that contains an additive called barium sulfate—that should have been deemed unsuitable because it compromises the structural integrity of the implants.

Barium sulfate is a low-cost radiopacifier that allows Bard’s medical devices to be viewable via X-rays and imaging. Adding a high concentration of barium sulfate to plastic degrades the integrity of the material and can lead to mechanical issues. The catheter tubes developed by Bard are alleged to contain too much barium sulfate, making them susceptible to cracking, fissures, and fracturing that pose serious health risks.

Inadequate Labeling

The FDA considers most ‘labeling’ as advertising, which includes informational materials accompanying a medical device. Bard has historically promoted the features and benefits of its PowerPorts™ and ignored the potential risks and complications. Healthcare providers and consumers did not have adequate information to assess the safety of the implantable Bard PowerPorts™ versus the convenience Bard promised.

The lawsuit involves the Bard PowerPort™ and ClearVUE™ Port. Bard marketed these ports as the first metal-free ports available, citing them as ‘MRI Safe’ and ‘CT compatible.’ The ClearVUE™ device was described as a “durable plastic port and ChronoFlex™ Polyurethane Catheter.” Using ChronoFlex (Bard’s iteration of a polyurethane and barium sulfate material) to achieve the metal-free design compromised the integrity of the devices and should not have been branded as ‘durable’ or ‘safe.’

Concealed Dangers

Once Bard’s devices passed the 510(K) approval, the company requested to join the FDA’s Alternative Summary Reporting (ASR) program. Bard manipulated this system to effectively ‘hide’ device failures, knowing the FDA did not carefully monitor the database or make reports public. Despite receiving adverse event reports (AER), Bard did not make these AERs public, thereby failing to inform consumers and healthcare professionals about PowerPort™ risks. It was only when the ASR program was dismantled and replaced with a more transparent reporting system that a high volume of PowerPort™ adverse events became publicly known.

Bard breached its duty to provide consumers with a safe product and to protect them from unnecessary harm. Not only did Bard create defective products, but it also continues to profit from these implantable ports. Bard has not changed the design, nor has it recalled any devices to protect future port users. Hundreds of people have already filed lawsuits against Bard. If you have experienced an injury related to a defective Bard PowerPort™, our lawyers want to help—tell us your story and let’s get started.