AngioDynamics Vaxcel Port Lawsuit Filed After Catheter Fractured in Patient’s Body

A piece of the fractured AngioDynamics Vaxcel port migrated into a woman’s heart and was unable to be removed.

A New Jersey woman claims in a recently filed lawsuit that a defective AngioDynamics Vaxcel port catheter fractured inside her mother’s body during an attempted removal procedure, resulting in severe adverse health problems.

The complaint (PDF) was brought by Sheila Goodson, the daughter of Krystal Johnson, in New Jersey federal court on December 23, naming AngioDynamics, Inc. and Navilyst Medical Inc. as defendants. While the lawsuit notes that Johnson is deceased, it does not attribute her death to issues with the Vaxcel port.

AngioDynamics port catheters are implantable venous access devices, consisting of a port component that provides easy access for doctors to administer medications and other fluids, as well as a catheter that carries those fluids into the patient’s bloodstream. They are commonly implanted for patients undergoing chemotherapy or other treatments, and have been in use for more than two decades.

Despite claims made by the manufacturer that the devices are safe and can be left under the skin for long periods of time, a growing number of port catheter lawsuits allege that the AngioDynamics products were defectively designed and are prone to developing microfractures due to the materials used in their construction.

More than 70 product liability lawsuits have been filed against AngioDynamics throughout the federal court system, each raising similar allegations that patients experienced devastating injuries, due to the high risk of fracturing, migrating out of place, or causing the development of severe infections. However, AngioDynamics port catheter lawyers expect that number to increase significantly in the coming months and years.

Goodson’s lawsuit states that her mother had a Vaxcel port implanted in January 2011 for chemotherapy treatment, which was removed by July 2014.

However, during the removal procedure, doctors discovered that the Vaxcel port catheter had fractured, with the pieces migrating to the right ventricle of her heart. While Johnson underwent emergency surgery to have the fragment removed, surgeons were unsuccessful, and had to leave the fragment in place until her death, the lawsuit indicates.

Goodson’s lawsuit claims the manufacturers knew this was a problem for years, but refused to change the nature of the product’s construction or remove it from the market.

“Soon after the Vaxcel was introduced to market, which was years before Decedent was implanted with her device, Defendants began receiving large numbers of adverse event reports (‘AERs’) from health care providers reporting that the Vaxcel was fracturing post-implantation and that fractured pieces were migrating throughout the human body, including to the heart and lungs,” the lawsuit states. “Defendants also received large numbers of AERs reporting that the Vaxcel was found to have perforated internal vasculature.”

The incidents included reports of hemorrhaging, heart rhythm problems, severe and persistent pain, perforation of tissue and organs, and even death.

Goodson presents claims of negligence, design defect, failure to warn, breach of warranty, fraudulent concealment and violations of the New Jersey Consumer Fraud Act, seeking both compensatory and punitive damages.

AngioDynamics Port Catheter Lawsuits

Goodson’s complaint will likely be consolidated with a growing number of similar AngioDynamics port catheter lawsuits, which have been centralized for pretrial proceedings under U.S. District Judge Jinsook Ohta in the Southern District of California.

In November, Judge Ohta held an initial status conference for the litigation. As the litigation progresses, it is anticipated that he will establish a bellwether trial process, which will result in the selection of a handful of representative cases for early trial dates. These trials will allow both parties to evaluate how juries may react to evidence and testimony that will be presented repeatedly throughout the courts during the litigation.

Following coordinated discovery and any bellwether trials in the MDL, if the parties are unable to reach any settlement agreements or another resolution on the AngioDymanics port catheter lawsuits, Judge Ohta may remand each case back to the U.S. District Court where it was originally filed for a future trial date. However, pretrial proceedings in the AngioDyamics port catheter MDL will likely take several years.