What Is the Product: Bard’s implanted port systems are implanted vascular devices designed to provide repeated access to the vascular system for the delivery of medication, intravenous fluids, parenteral nutrition solutions, and blood products without the use of needles. The devices are often used for patients undergoing cancer or rheumatoid arthritis treatment.
What Is the Issue: The catheter portion of the devices are prone to fracturing and migrating to the heart. Such events can cause serious cardiac complications, including death. For many years Bard has misled physicians and the FDA into believing that fractures only occur due to physician error in placement technique resulting in “pinch off.” However, Bard has long known that these devices are actually fracturing due to a design issue not physician error. These devices are designed in such a way that once implanted in body they suffer chemical degradation and fatigue failure. Indeed, Bard uses chemicals (Barium sulfate) in its catheters that are not recommended for long term implantation in the body because they are known to degrade once exposed to bodily fluids. Bard has also used materials in its catheters regarding which the suppliers warn the material has never been tested for long term implantation in the human body. Bard’s implanted port systems also cause blood clots and pulmonary emboli which can be life threatening.
Status of the Litigation: The Judicial Panel on Multidistrict Litigation has ordered that all federal cases will be coordinated before Judge David Campbell in the United States District Court for the District of Arizona. Judge Campbell will oversee common issues relating to discovery and pre-trial rulings and trial of a number of bellwether cases. Judge Campbell is the same judge that oversaw the Bard Inferior Vena Cave Filter litigation.
Brenes Law Group’s Experience with Bard: Our firm has extensive experience litigating and resolving medical devices cases against Bard, including IVC Filter, hernia mesh, and implanted port cases. Regarding Implanted port systems specifically, we have already resolved cases for our clients and have worked for years to develop the science of why Bard’s catheters fail.