Written by Rick Busby
for Provost Umphrey
As of July 2015, there are now hundreds of active plaintiff
lawsuits against G.R. Bard involving allegedly defective IVC Filters, while
competitor Cook Medical is nearing 100 active suits surrounding the failures of
their own similar IVC Filter products. In August 2012, the FDA published a
Safety Communication regarding the Bard IVC Filter and since then the frequency
of lawsuits has been on the rise with Bard and Cook being the two primary
manufacturers being named as defendants.
While a few of these suits have reportedly been consolidated
into Class Action suits, the vast majority of the suits are single plaintiff
pleadings. In cases making headlines in the first half of 2015, it appears
there is a trend toward settlement, especially by Bard, but only after the
trial has commenced.
For example, in February, Bard attorneys settled a Nevada
case with plaintiff Kevin Phillips after 10 days of trial. Phillips filed his
suit in 2012 alleging that a piece of the Bard IVC Filter installed in an
earlier procedure had broken off of the filter, migrated to his heart and
perforated the inferior vena cava. Phillips’ complaint is one of the more
common allegations received by the FDA, which published their Safety
Communication in 2012 after having received nearly 1,000 filed complaints on
the defective devices.
What is an IVC
An Inferior Vena Cava (IVC) Filter is a medical implant
device designed to trap blood clots before they can travel into the lungs and
trigger a potentially life-threatening pulmonary embolism. While designed to
protect patients during the post-operative period of recovery, during which the
risk of blood clotting is higher than usual, the devices are instead proving to
be potentially lethal themselves.
IVC Filters have been in use since the 1960’s and it is
estimated that more than 100,000 of the devices have been installed over time.
Since the devices were not originally intended for permanent placement, their
design allowed for them to be recovered later in a second procedure after the
risk of blood clotting and pulmonary embolism had returned to normal. However,
the urgency of timely removal apparently relaxed over time resulting in IVC
Filters remaining installed long after the risk had subsided, which increased
the chances for the IVC Filters to fail over time.
How Do IVC Filters
To understand how IVC Filters fail, it is helpful to
visualize it as a spider-like, wire device implanted snugly against the
interior walls of the inferior vena cava. It is designed to catch a blood clot
before it can pass into the lung. Trapped inside the spider-like legs of the
device, the clot would then have an opportunity to degrade and ultimately
dissolve before it ever gets to the lung.
The challenge is that each one of the device’s extremities
can potentially fracture under the normal operational stresses and then be whisked
away into circulation in the blood stream just like the clots they are designed
to trap. Once the fractured fragment is freely circulating in the blood stream,
it could ultimately migrate into the heart or lungs and potentially trigger
In addition to the fracturing and migration issues, IVC
Filters have also been known to perforate the interior walls of the inferior
vena cava creating cardiac events. In 2012, a study published in Cardiovascular
Interventional Radiology disclosed that 100 percent of the Cook Medical IVC
Filters installed in the study’s participants had perforated the interior venal
wall of the inferior vena cava within 71 days of their original implantation.
Many of the FDA complaints received reported the “tilting” of
devices from their originally installed optimum positions, which increases the
risk of a clot getting past the device and decreasing the device’s intended
effectiveness with potentially fatal consequences. The same 2012 study also found that IVC
Filters installed in 40 percent of the study’s participants had tilted away
from their originally implanted position.
These types of failures also increase the risk that doctors
will be unable to effectively retrieve and recover the device as recommended.
Since the devices were never designed to be permanent fixtures, being unable to
retrieve and recover a failed device increases the patient’s risk of having a
potentially life-threatening event over time. The FDA’s current recommendations
regarding routine retrieval and recovery of IVC Filter devices is 29 to 54 days
after their original implantation.
Recalls, Bans and
Due to the rising controversy and potentially fatal
implications, many health advocates are calling for a wholesale recall of the
IVC Filters, while others are advocating the harsher course of an outright ban
on the devices. To date, neither of those calls has gained any significant
traction and do not appear likely to do so in the near future.
While cries for recalls and outright bans are not currently
gaining traction, the projected five-year PRESERVE Study (Predicting the Safety
and Effectiveness of Inferior Vena Cava Filters) has commenced to study the
issue. Once the clinical trial study concludes, there will then likely be additional
and indeterminate time needed for researchers to analyze, vet and publish the study’s
findings. After that, the FDA would then do its own study of the data, which
could include convening expert panels to consider next steps. Assuming the PRESERVE
study itself concludes on time, it could take nearly a full decade before the “next
steps” would be disclosed to the public. At stake are potentially billions of
dollars on one hand and the lives of innocent patients on the other.
For patients with currently installed IVC Filters, another
decade before recommendations are published may be too little too late. If you
have had an IVC Filter installed for more than 60 days and it has either not
been retrieved or cannot be retrieved due to malfunction, it is advisable to
contact a legal professional to discuss your circumstances. It now appears the IVC Filter lawsuits will
be in the news for some time to come. It is in your best interests to stay
informed and to have legal professionals in your corner in the event your IVC