Cancer patient Johanna Randow was implanted with a Bard Infuse-A-Port device in 2018 as part of her chemotreatment.
The small device is used to administer treatments such as chemotherapy medication once it is attached to a vein. According to Cleveland Clinic, the port can remain in place for years.
When Randow had the Bard PowerPort device removed a year later due to not functioning, she thought nothing of it further. That is until November 2021.
Two years later, she was diagnosed with a pulmonary embolism. Medical testing revealed Randow had a fragmented piece of the catheter lodged in her heart.
Randow still lives in fear that the catheter fragment will cause more damage while she suffers from cardiac arrhythmia and intense pain.
Product Liability Lawsuit
Before Randow filed a liability lawsuit in 2023 against product manufacturer Bard Access Systems, various complaints had already been lodged against the company. The difference is that her case catapulted the lawsuit into the public eye.
The port catheter lawsuit currently has 50 cases consolidated in the Bard implanted port catheter products liability litigation.
Like other patients, Johanna Randow was assured that the implantable device was safe for use… that is, until it wasn’t.
As it now stands, 232 Bard PowerPort lawsuits are pending against Bard Access Systems owner Becton, Dickinson, and Company.
Bard PowerPort Recall
The lawsuit claims that defects within some Bard PowerPort catheters can result in serious injuries, says TorHoerman Law.
Patients who filed Bard PowerPort cases complained of complications like catheter fractures, blood clots, and deep vein thrombosis.
The DFA announced a recall in 2020 due to the device’s design flaws, which allegedly caused the complications.
Drug Watch reported that the Class A recall affected three models. Technically, a Class A recall warns of a potential risk but not a high probability of serious harm.
The recall warned Australian patients that the incorrect tips could dislodge from the catheter but that patients would sustain minor injuries. They added the defective device wasn’t meant to cause long-term health problems.
While concern for the product was mounting, the FDA terminated the recall in 2022.
The current lawsuit against Bard relates to the design flaws in the Bard PowerPort. The lawsuit states that the company knowingly marketed the defective port without making the necessary changes. Plaintiffs also claim Bard didn’t provide adequate warnings.
Revolutionary Design?
The first Bard PowerPort device was introduced in 2000 after gaining FDA approval.
The device was hailed as a revolution in the medical device field, thanks to the cutting-edge design and materials used in its manufacturing. Now, these very same features are contributing to lawsuits.
Polyurethane and barium sulfate in the catheter proved most problematic. Combined, they could deteriorate over time.
Doctors became concerned by the 6% infection rate associated with the implant. Citing a 2017 study, Binfire reported that those infections led to severe complications, including sepsis.
Some patients required surgical intervention after experiencing fibrosis around the port site. Medical professionals found themselves in a precarious situation when enacting stricter protocols.
Past Offenses
This isn’t Bard’s first brush with personal injury lawsuits. Consumer Notice reported that the company settled a lawsuit regarding its defective pelvic mesh products in 2014, reportedly paying out $21 million.
Then, in 2020, it faced more lawsuits for marketing defective pelvic mesh products and settled for $60 million. A year later, another one of its pelvic mesh products was under scrutiny.
The plaintiffs claimed the products caused infections, intestinal blockage, and organ perforation.
Bard’s Uncertain Future
The essential aim of the Bard PowerPort was to simplify medication delivery without the discomfort of needles.
Parent company Becton, Dickinson, and Company was accused of downplaying the adverse side effects of the device. If the lack of transparency can be proven, Bard Access Systems could be the focus of many future lawsuits.
The U.S. Judicial Panel on Multidistrict Litigation has centralized all Bard PowerPort lawsuits into an MDL.
This means the consolidation will allow for coordinated discovery and motion practice. Settlement negotiations could even be determined before the cases go to trial.
It’s impossible to predict how far the cases will develop, but Bard PowerPort lawyers say they’re still accepting new claims.
In the meantime, many patients affected by the device’s side effects are forced to wait in limbo. All they can do is hope for a favorable outcome in the port catheter lawsuit.