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.