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IV infusion pump tube set with blur patient on bed in clinical hospital

A North Carolina man recently filed a new Bard PowerPort lawsuit against manufacturer Becton, Dickinson, and Co., in the U.S. District Court for the Middle District of North Carolina. He claims that after he was implanted with the medical device, he suffered from serious injuries. He seeks compensatory and punitive damages.

Given the increasing number of these types of lawsuits, a group of plaintiffs recently filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all of them into one court for more efficient pre-trial proceedings.

Plaintiff Claims Bard PowerPort Leaked Chemotherapy Medication

According to his complaint, the plaintiff was implanted with the PowerPort via his right internal jugular vein on February 22, 2022. Doctors implanted it to administer chemotherapy to treat his colon cancer.

A couple of months later, on April 12, 2022, the plaintiff underwent one of his chemotherapy sessions. Doctors infused the chemotherapy drug Oxaliplatin through the PowerPort into the plaintiff’s bloodstream. About halfway through the session, he claims that he began experiencing pain, burning, and swelling above the PowerPort site.

Healthcare personnel immediately checked his port. They found that it had ruptured and was leaking chemotherapy medication into his body. They were unable to remove the defective device that day, however. The plaintiff had to wait about a month to get it removed.

On May 10, 2022, he underwent a procedure to remove and replace the defective PowerPort. He claims that because of the faulty device, he suffered pain and emotional distress, and had to go through unnecessary major surgery.

Plaintiff Claims Manufacturer Was Aware of the PowerPort’s Defects

The Bard PowerPort is one of several implantable port/catheter systems meant to provide repeated access to the vascular system for the delivery of medication, intravenous fluids, parenteral nutrition solutions, and blood products.

The purpose of these products is to make it easier to deliver medications directly into the patient’s bloodstream. The device is surgically placed completely under the skin and left implanted for repeated use.

The Bard PowerPort system consists of two components: an injection port and a polyurethane catheter. The polyurethane used to make the catheter is called Chronoflex AL, which is comprised of a polymeric mix of polyurethane and barium sulfate.

Barium sulfate, however, is known to reduce the mechanical integrity of polyurethane in vivo as the particles of barium sulfate dissociate from the surface of the catheter over time. This makes the catheter more likely to crack and leak.

The manufacturer could have used a different polymer formulation to reduce the risk of leakage, but they didn’t. Soon after the company released the product onto the market, it began receiving large numbers of adverse event reports from healthcare providers noting that the PowerPort was fracturing after implantation and that fractured pieces were migrating through the human body, including to the heart and lungs. Other reports indicated the PowerPort had perforated internal vasculature.

These failures were often associated with reports of severe patient injuries like hemorrhage, cardiac arrhythmia, cardiac tamponade (when fluid puts pressure on the heart), and severe and persistent pain. Nevertheless, the company continued to market the implant as safe.

The U.S. JPML will hear arguments in later July 2023 concerning the motion to consolidate all Bard PowerPort lawsuits.

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