Bard PowerPort Lawsuit: Hope Abounds Amid Major Progress 

In the past 100 years or so, medical science has made unprecedented progress. This progress is not merely limited to medication or vaccines. Novel treatments are emerging with the help of Artificial Intelligence (AI) and Machine Learning (ML). 

Mankind is turning its face towards the possibility of discovering cures for rare and incurable conditions. As published by ABC News, some of the latest medical breakthroughs to closely follow include over-the-counter birth control pills, FDA-approved medication for Alzheimer’s, and AI-based cancer detection. 

In a similar vein, the Bard PowerPort was introduced back in 2000 to access the patient’s vascular system. Fast forward two decades and the US District Court for Arizona is tackling a growing number of lawsuits against the said medical device. In this article, we will discuss the litigation in detail along with much-awaited progress made recently. 

Premise for the Litigation 

Ever since the Bard PowerPort was granted marketing approval in 2000, the device has been a significant part of the medical industry. The catheter tube of the device is implantable so that drugs can be directly administered into the patient’s bloodstream. 

Its primary advantages were reserved for those requiring frequent vascular access for chemotherapy, dialysis, or parenteral nutrition (PN). The device’s manufacturer, Bard Access Systems, claimed the following benefits –

• Reduced risk of vein damage since patients need not be punctured by needles frequently
• Better chances of survival during emergencies due to faster drug administration 
• Enhance patient satisfaction due to shorter treatment duration and reduced discomfort or pain 

Though the device did stand up to its claims as far as the effectiveness was concerned, it seemed to have failed from the safety viewpoint. TorHoerman Law states that patients and healthcare practitioners complained of injuries like blood clots, infections, and organ perforation, among other complications. 

As a result, many filed the Bard Power Port lawsuit in April 2023. Today, this litigation has been consolidated into a class-action multi-district litigation (MDL). It is ongoing with new cases being filed every week. 

A Year in Review and the Seventh Case Management Order 

The injuries are not the only problem for which the litigation against Bard Access Systems became necessary. Plaintiffs have also alleged that the device manufacturer was fully aware of the repercussions and risks but issued no warnings. 

Patients were undoubtedly unaware but so were numerous healthcare providers. Over time, the primary cause of device failure was discovered. It turns out that the polyurethane material used to produce the catheter port, called Chronoflex AL, is the problem. 

Its particles are prone to dissociating from the catheter’s surface, thereby migrating to different parts of the body. The structural alterations in the device compromise its mechanical properties. By the end of 2023, the MDL was ready and assigned to Judge David Campbell in the US District Court of Arizona. 

As far as case numbers are concerned, the progress was mild as 69 lawsuits were filed by the end of December 2023. It was likely that the lawsuit’s fame was spreading far and wide as case numbers jumped to 110+ by the time March rose above the horizon. 

Attorneys had predicted that this would be a smaller MDL and as such, would move rather quickly. Thankfully, they were not disappointed since the progress reached the seventh Case Management Order by the end of May 2024. 

This Order laid down the ground rules for successor liability, discovery agreements, medical records, and assertion of port body claims. Once that was set in motion, the lawsuit made steady growth. The month of June saw an addition of 45 new cases. 

The Litigation’s Scope Expands 

Amid the gradual yet consistent progress, plaintiffs were offered the happy news of litigation expansion. In other words, the court was willing to consider alternative theories of causation that led to power port-related injuries. Such theories, including reservoir defects, were not previously considered. Only issues with the catheter itself were taken into account. 

A proposal to include reservoir defects was made at the beginning of the litigation. However, it was turned down on the grounds of raising ‘novel’ theories that had no basis. Essentially, these lawsuits alleged that the design of the port reservoir using polyoxymethylene (POM) is condemnable. 

This is because it is a well-known fact that the POM material undergoes oxidative degradation when exposed to radiography. Naturally, it would weaken and break apart and lead to infections. 

The theory stated above may be an alternative theory of causation but it remains largely the same as the original one. The transfer order passed early this year shows great promise in serving proper and speedy justice. 

In 2020, the FDA issued a Class 2 recall for three models of this device in light of severe injuries. Since the device forms such an indispensable part of the medical industry, it’s unlikely that it will be banned altogether. We can only hope that injuries do not persist and in cases where they have, the victims receive fair compensation.