Philly. Jury Awards $33M Over IVC Filter Injury

Philly. Jury Awards $33M Over IVC Filter Injury

Introduction

In one of its first cases over inferior vena cava or IVC filters, a Philadelphia jury awarded more than $33 million to a woman who was injured by a defectively designed blood filter.

According to the court filings, the plaintiff, a Georgia resident, got blood filter implants, manufactured by Rex Medical and distributed by Argon Medical Devices, in December 2016. The device later penetrated through the wall of her vena cava, causing severe pain and complications, which induced fear and anxiety that the device may fracture and lead to casualties. The allegations include negligence, strict liability, design defect, manufacturing defect, breach of warranty, and negligent misrepresentation claims.

The jury awarded the plaintiff $1,045,764 million in future medical expenses and $2,322,650 million in future pain and suffering. The jury also awarded an additional $30,315,726 in punitive damages.

C.R. Bard, Cook Medical, and Boston Scientific are also facing similar allegations, each claiming that plaintiffs suffered painful and potential complications when the small devices moved out of position, penetrated internal organs, or fractured, causing small pieces to travel throughout the body.

Inferior vena cava, or IVC, filter complications include device penetration, fracture, migration, and eventual blood vessel narrowing with risk of leg swelling and blood clots. Most IVC filters will not result in complications after short dwell times, but the risk of complications increases the longer a filter remains implanted.

Blood clot filters are devices that are sometimes placed in the largest vein in the abdomen (IVC) to prevent large blood clots formed in the leg veins from traveling into the lungs. To reduce the risk of potential complications, experts recommend removing the filter as soon as the device is no longer needed and preferably within 2-3 months after implantation.

In 2010, due to rising filter-related complications reported to its database of adverse events, the FDA issued a Safety Alert on IVC Filters. The complication of IVC includes migration to the heart or lung, vein perforation, blockage of blood flow causing clots, misplacement, and access site bleeding. 

Depending on the type of complication, many patients may experience no immediate symptoms while others may develop immediate pain or severe problems years later. In some instances, the side effects can be painful and dangerous.

If a filter has been implanted for several years, patients should initially consult with their local doctor to assess the status of their device. It could be evaluated with routine x-rays or a CT scan, and they should at least be followed by a local physician. If there is any uncertainty regarding possible complications, then the case should be reviewed by a knowledgeable specialist.

When a filter strut breaks loose, makes its way through the bloodstream, and enters into the heart or lungs, this is called embolization. These patients can suffer acute chest pain similar to a heart attack.
Adverse event reports submitted to the U.S Food and Drug Administration (FDA) between 2005 and 2010, included 146 reports of embolization out of 921 total reports. Embolization of IVC filters to the heart and lungs can have serious and sometimes deadly consequences. Signs and symptoms of this condition might include acute chest pain, abnormal heart rhythm, shortness of breath, feeling faint, and loss of consciousness.