A recent lawsuit filed in a California federal court highlights many of the issues surrounding IVC filter litigation and liability. Plaintiff Michael A. has named medical device manufacturer C.R. Bard as defendant.

The plaintiff alleges serious injuries resulting from the implantation of an inferior vena cava (IVC) filter designed, manufactured and sold by Bard. He is seeking damages for negligence, failure to warn, defective design and breach of warranty.

What is an IVC Filter and Why is it Used?

The inferior vena cava filter was first used in 1968. Described as an “umbrella” filter, this device was designed to be inserted into the main artery that carries blood from the lower extremities to the heart; its purpose, then as now, was to trap potential blood clots before they could reach the heart, lungs or brain and thus avoid a stroke or embolism. Over the next few decades, additional designs were introduced.

The specific products at the center of current IVC litigation are designed and manufactured by C.R. Bard. IVC filter litigation involves several different IVC filter models, released sequentially over the past two decades. In chronological order, these are:

• Recovery (2002)
• G2 (2005)
• G2 X (2008)
• Eclipse (2010)
• Meridian (2011)
• Denali (2013)

Michael’s complaint notes that all models that followed the initial Recovery model (identified with an asterisk) had all been approved through the FDA’s questionable and controversial 510(k) Premarket Notification process. This allowed the manufacturer to bypass normal, and costly, studies and clinical trials by claiming each model was “substantially equivalent” to its predecessor.

The lawsuit claims that each model continued to have the same defects – specifically, a tendency to fracture and migrate, allowing metal shards to be carried to other organs through the bloodstream.

IVC filters produced by Cook Medical face the same complication.

Injuries Claimed in IVC Filter Litigation

Not surprisingly, the metal fragments resulting from the fracture or migration of an IVC filter causes severe, and even fatal injuries. Some of the injuries described in detail in Michael’s complaint include:

• perforation of blood vessels and organs
• hemorrhage
• pericardial tamponade (fluid build-up in sac surrounding the heart)
• arrhythmia
• heart attack (myocardial infarction)

Any of these can and have resulted in death.

Michael states that he was implanted with a Bard IVC Filter in March 2009. Since that time, he has suffered chronic physical pain as well as mental anguish. He requires ongoing medical care and monitoring for complications caused by his Bard filter.

Unfortunately, while IVC filters were intended for short-term use, they have proven to be extremely difficult to remove. Some plaintiffs in IVC filter litigation have described it as living with a “time bomb” inside their bodies.

Michael believes that C.R. Bard designed and distributed a product they knew or should have known was dangerous, and failed to take reasonable precautions in their design and manufacturing. His IVC Filter Lawsuit is Case No. 1:19-cv-00085-DAD-EPG, U.S. District Court, Eastern District of California.