Originally approved by the FDA in 2000, the Bard PowerPort was designed as an implantable port for easy, long-term access to administer chemotherapy, medication, fluids, and nutrition directly into the bloodstream. However, since its introduction, numerous patients have reported complications with the device, including fractures and migration of the catheter. These issues have been linked to serious health risks, such as infections, blood clots, punctures of the heart, fragments becoming trapped in either the heart or lungs, and other life-threatening injuries such as septic infections.

While the initial concept of the Totally Implantable Venous Access Device (TIVAD) was first approved in 1981, numerous variations of the device have since been approved since the original PMA, and all of the current devices sold today have been approved via the 510(k) fast track process by the FDA. Becton Dickinson’s (NYSE: BDX) Bard subsidiary maintains roughly 80% market share for sales of these devices in the United States with their PowerPort® being the flagship product.

Medical Research

A peer reviewed meta analysis published in 2021, which encompassed more than 93,000 patients with an insitu time of up to five years revealed an alarmingly high complication rate of 59%. The same study defined an infection rate in the population of nearly 18%, thrombovascular events (blood clots) occurred in nearly 37% of patients, and mechanical complications for the devices (including catheter fracture and migration) were reported in more than 10% of patients with the device implanted. This study was extraordinarily significant as it was the first study to look at insitu values beyond nine months. Especially considering manufacturing reps and medical professionals are recommending these devices be left in for years, and in some instances, in perpetuity. The size of the patient population of this meta analysis ensures statistically significant confidence levels in the veracity of the data and conclusions drawn. A design defect during the manufacturing of the catheter tube for these devices has been identified in numerous studies^(2)(3)(4), which researchers believe is the likely contributor to the injuries reported by patients.  

Manufacturers including those producing and selling TIVAD devices had utilized the now defunct Alternative Summary Reporting ‘self reporting’ program (ASR) from 1997 through April 2019, when it was shuttered after a scathing exposé in Kaiser Health News showed how manufacturers were hiding issues not only from the public, but also from medical professionals by only reporting Device Experience Network (DEN’s), and not reporting the same issues as Medical Device Reports (MDR’s) on the public MAUDE database. An example of this egregious practice was that from 2004-2010 there were 0 MDR’s reported to MAUDE by port-a-cath manufactures, while there were over 3,600 DEN’s filed in the ASR. From 2004-2017 there were more than 9,000 DEN’s submitted, while only 1,200 showed up in MAUDE. This lack of transparency likely led to a false sense of safety and security by medical professionals during the rapid adoption and utilization of these devices over the past two decades.

Current Status Of Litigation

On August 8, 2023, the US Judicial Panel of Multidistrict Litigation (JPML) ordered the consolidation of cases into MDL #3081, with cases transferred to the U.S. District Court of Arizona, where they will be centralized under the supervision of Judge David G. Campbell. Judge Campbell, who previously presided over the Bard IVC Filters MDL #2641, has moved the PowerPort litigation forward at a ‘rocket docket’ pace. Judge Campbell set a deadline of April 5, 2024 for all potential bellwether trial picks to be submitted. He is moving discovery forward rapidly with the Daubert hearing planned for later in 2024. Judge Campbell has been adamant that only six bellwether trials will take place, all in 2025, and that he wants this matter resolved and off of his docket in 2026.

Links:

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8077681/
2. https://www.ajronline.org/doi/full/10.2214/AJR.17.18125
3. https://www.sciencedirect.com/science/article/abs/pii/S1751616116302582
4. https://www.ajronline.org/doi/full/10.2214/AJR.17.18125
5. https://kffhealthnews.org/news/hidden-fda-database-medical-device-injuries-malfunctions/