In March of 2018 jury awarded 2 million dollars to a woman who suffered serious injuries from an IVC Filter, which is a blood clot capturing device made by C. R. Bard Inc. Bard is liable for $1.6 million of the amount, and a radiologist who failed to find a splintered piece of the IVC filter in an X-ray was responsible for the remainder of the verdict.
What is an IVC Filter?
An IVC filter (pictured above) is implanted in the inferior vena cava and is intended to trap blood clots and prevent them from reaching the heart or lungs. Often doctors recommend IVC’s for patients who cannot take blood thinners. IVC Filters have risks of migrating or the legs of the filter can splinter or break, they can puncture vessels or “tilt” thus impacting the ability to prevent clots from moving. Studies have shown that between 31 and 40% of all defectively designed IVC filters eventually fracture. The drifting filter or filter “legs” can pierce or become lodged into the heart, lungs or other organs. They can also block blood flow in the blood vessels or arteries. Additionally, the fractured or migrant filter may end up releasing trapped blood clots.
Because of these risks associated with IVC filters, the FDA recommended that doctors remove the IVC filters after a clot dissipates, which is usually one to two months. In many cases the surgery to remove the filters is unsuccessful if the filters have moved or splintered or perforated arteries or organs.
The IVC trial that just concluded involved a woman who had a Bard IVC filter implanted in her inferior vena cava. This device fractured and pieces of the filter pierced her spine and heart, requiring her to undergo open-heart surgery.
Are the Manufacturers of the IVC Filters Responsible?
In 2015 an FDA letter to Bard, Inc. indicated that Bard manufactured an unapproved IVC filter and did not accurately report complications associated with certain of its IVC filters. There are indications that Bard actually knew the risks that their IVC filters posed dating back to 2003. Bard employed an independent doctor to study and evaluate certain IVC filter models. The doctor found that the Bard some models had greater risks of death, fracture and migration than competitors. This study was never presented to the medical community nor the public, yet Bard continued to market and sell this medical device until it had a new device ready for market in 2005.
Other manufacturers of IVC filters alleged to be dangerous include Cook Pharmaceutical and Cordis.
What do I do if I believe I have been injured by an IVC filter?
The recent $2 million dollar verdict against Bard (as well as many scientific studies) would seem to substantiate the claims that IVC filters can pose serious health risks. If you have had an IVC filter implanted since 2002 and have suffered complications from this device, you should consult with an attorney who is experienced in pharmaceutical device cases. Attorney Brett Oppenheimer has experience in pharmaceutical product liability, medical device litigation and medical malpractice cases and would like to consult with you to help answer your questions and determine if you have a case to pursue. Please contact Brett H. Oppenheimer, PLLC, by completing a contact form on this website or give him a call at (502) 242-8877.