Allowing easy access to a vein, implanted ports are commonly used for dialysis, transfusions, and IV treatments. They are suitable options even for chemotherapy as fewer needles are required for the procedure.
Bard PowerPort is also an implantable catheter device manufactured by Bard Access Systems, Inc. The product has been in the medical market since 2000 after receiving its Food and Drug Administration (FDA) approval.
At the time of its emergence, healthcare providers had high hopes for Bard PowerPort. It was considered to be revolutionary in some sense, efficiently transferring medications to the patient’s bloodstream. However, today there is an active lawsuit across Federal courts against the manufacturer.
Though close to trial, the litigation is moving at a snail’s pace. In this article, we will discuss the Bard PowerPort litigation in detail to understand why.
Allegations against the Manufacturer
When Bard introduced its catheter device, the manufacturer claimed that it was perfectly safe to use. In other words, the lofty product claims made Bard PowerPort an effective and safe product with no design defects (in the eyes of healthcare providers and patients).
However, the last few years have testified to the increasingly alarming complications associated with device failure. According to TorHoerman Law, some of the serious injuries victims have sustained include catheter fracture and migration, arterial puncture, deep vein thrombosis (DVT), blood clots, stroke, and collapsed lung, among others.
What’s even worse is that internal documents have surfaced showing that the company’s team had prior knowledge of the risks. The prime allegation in the Bard Power Port lawsuit is that the defendant showed deliberate disregard for public safety with no warning of associated dangers. The magnitude of the deception (once clear) will determine fair settlements for plaintiffs.
Lawsuit Consolidation into Class-Action MDL
Just a few months following Bard PowerPort’s market launch, adverse reports had started piling up. However, the litigation is fairly nascent, with attorneys still assessing the extent of punitive damages plaintiffs could receive.
One promising aspect was that the litigation has been strengthening for the plaintiff’s counsel with each case. The complications are worsening, and it is believed that a surprisingly large number of people may have been affected.
Sometime after the litigation began, Bard was asked to modify the power port’s design to make it safer. The complications seemed to originate from the product’s material – high concentrations of barium sulfate.
This chemical compound damages the mechanical integrity of polyurethane, thereby leading to degradation, breaking, cracking, and microfractures. Bard refused to change the catheter’s design, further weakening the chances of a verdict in its favor.
The manufacturer is still marketing Bard PowerPort aggressively, calling it safe to use. In March 2020, the FDA even announced a product recall, later terminating it in May 2022. In August 2023, all lawsuits were consolidated into a class-action multi-district litigation (MDL) despite much resistance from the defendant.
This was done because case numbers are expected to rise by next year. During case consolidation, there were only 10 pending cases, but the numbers quickly rose to 50 within the following two months.
After the class-action MDL was formed, stronger cases were filed. A Chicago woman had a Bard PowerPort implanted in her neck for chemotherapy. Within just nine months, the catheter fissured, and its pieces migrated to different parts of the body.
The woman had to undergo several surgeries for fragment removal, some found around her heart. By October 2023, 62 cases were pending across Federal district courts. Lawyers were expecting at least 100 cases each month.
However, the progress has been slow, with no new cases filed in November yet. Given the 300,000 catheter devices installed countrywide, at least 8,000 cases are expected to become a part of the MDL. As of now, a meager figure of 62 indicates the early stage of the litigation.
Also, healthcare providers may be unable to identify that the catheter is the root issue behind a patient’s complications. As awareness grows, the case numbers should increase as expected.
Judge Campbell has pushed the Bard PowerPort litigation forward, even as far as proposing a Bellwether trial plan. As per the plan, both sides must select 24 cases each (a total of 48 cases) by July 1st, 2024.
These cases would form the initial plaintiff pool. During the discovery process, 15 cases will be chosen for the Bellwether trial by December 17th, 2024. Out of these, the defendant and plaintiff’s sides will select five each, whereas the remaining five will be chosen jointly.
If the trial outcome is in favor of the plaintiff’s counsel, a global settlement will be made. Then, possible settlement amounts for individual cases (even those not included in the trials) can be determined.