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Our Attorneys Protect the Rights of New York Victims of Defective IVC Filters
The attorneys at
Queller, Fisher, Washor Fuchs & Kool are currently evaluating cases for New York IVC Filter injuries as well
as for injuries throughout the United States caused by defective and dangerous
IVC Filters. A consultation with us regarding your possible IVC filter
case is a completely free consult. The only fee that you will ever be
charged is a contingency fee that would come out of the proceeds of any
recovery at the end of your case.
The problems associated with defective IVC Filters have been the subject
of significant investigative reports by NBC Nightly News:
Do I Have An IVC Filter Lawsuit?
The IVC (Inferior Vena Cava) is a major vein in the human body which transports
blood from the lower body to the heart. The IVC Filter lawsuits claim
that the manufacturers of these cage-like, spider- shaped wire devices
failed to warn physicians and patients of the dangers of multiple serious
adverse events (SAEs). The purported purpose for insertion of the IVC
filter is to protect patients who are at a high risk of pulmonary embolism
(a PE is a condition whereby one or more of the arteries in the lungs
becomes blocked by a blood clot) or deep vein thrombosis (DVT), and thus
to catch blood clots in the filter to prevent such clots from going to
the heart, lungs, or brain. The IVC filter is and was supposed to work
by catching the clots while still in the bloodstream, and then allowing
the clots to break down over the course of time.
More specifically, the claims include allegations that manufacturers failed
to warn of the risks of these IVC filters:
- moving, tilting, angling, and migrating
- fracturing, splintering and/or breaking
- puncturing, perforating, or piercing internal organs, veins, arteries,
or other tissue
- lodging in and/or otherwise obstructing an artery
- actually causing pulmonary embolisms (the very problem the filter is designed
- causing injury to the heart and lungs
- causing other serious injury, including stroke and death
Why Is The IVC Filter Utilized?
The filters are commonly used for patients for which anticoagulant medication
is contraindicated, or upon failure of anticoagulant therapy in thromboembolic
diseases. The filters are also used where there is emergency treatment
following massive pulmonary embolism where the anticipated benefits of
conventional therapy have been reduced, or for chronic, recurrent PEs
where anticoagulant therapy has failed or is contraindicated. Anticoagulant
medications are drugs that are used to help prevent blood clots. Those
persons who are contraindicated for anticoagulants may include but are
not limited to persons subject to high bleeding risks, allergies, pregnant
women, and persons who have had recent surgery. Primarily the filters
are intended to be used temporarily, often to treat a transient (temporary)
risk of pulmonary embolism, and then be removed. However, this is yet
another problem with the devices, inasmuch as due to one or more of the
myriad of complications associated with the filters (listed above), the
filters have substantial retrieval complications. Sometimes retrieval
of the filters takes place only after multiple surgeries, or at times
the filter cannot be retrieved at all. The failure to warn of the complications
associated with retrieval of IVC filters is yet another claim against
the manufacturers of these devices.
What Symptoms Have Been Associated With IVC Use?
Some of the more common symptoms associated with complications caused by
IVC filters include:
- compromised respiration and/or shortness of breath
- heart rhythm irregularity
- nausea and/or lightheadedness
- neck pain
- Internal bleeding or hemorrhaging
Will My Lawsuit Be Brought Individually or as part of a Class Action?
If we accept a case on your behalf, your case will be brought individually
and not as part of a class action. You would sign your own retainer agreement
and not be subject to a class settlement. We find that many of our clients
are concerned inasmuch as class actions have a reputation whereby attorneys
garner a disproportionate amount of any monetary recovery. The IVC filter
cases brought by our firm and/or by firms we work with, where injury has
already been suffered, are customarily not class actions. Some attorneys
have filed cases as a class, but these cases allege damages for all persons
who have had the suspect IVC filters placed, and generally allege that
damages for such a class should be awarded for the increased monitoring
of health issues related to implantation of the device. These cases are
to be distinguished from cases brought individually for persons who have
already suffered serious injury or death, or who have already experienced
a substantial complication that has a likelihood of resulting in serious
injury. The precise attorney fees may be set by the court but the majority
of any net proceeds recovered by verdict or settlement of your case will
go to you, the injured party.
This does not mean that attorneys working on these cases representing injured
parties do not combine resources. In fact, IVC filter cases are widespread
and are usually referred to by attorneys as a mass tort. This means that
it is alleged that a large number of persons were injured by the same
or similar product. Generally speaking, the Federal Court System does
not like attorneys wasting the Court's resources by litigating the
same issues over and over again in cases brought in different venues all
across the country. For that reason, the cases are commonly joined in
what is known as a multi-district litigation (MDL). Currently there are
hundreds of cases, consisting of persons injured throughout the country,
whose cases have been filed as part of 2 separate MDL's. The MDLs
are against the 2 primary manufacturers of IVC Filers. C.R. Bard being
one (approximately 30% of market) and Cook Medical (approximately 40%
of market) being the other. In combination these manufacturers comprise
approximately 70% of the IVC Filter market. The Cook MDL is located in
Federal court in Indiana, and the Bard MDL is located in Federal court
in Arizona. While the Bard MDL has over 300 filed cases, and the Cook
MDL over 400 filed cases, it is estimated that several thousand IVC Filter
cases have been retained throughout the Country. There have already been
dozens of depositions and other discovery held prior to the formation
of the MDLs, with much more planned in the upcoming months.
Typically, in mass tort cases such as these, there are test or "bellwether"
cases that are decided by juries before decisions are made as to whether
the manufacturers will choose to resolve the mass of remaining individual
cases. The outcomes of these cases usually influence whether there are
large scale settlements to avoid the cost of hundreds or thousands of
separate jury trials that would otherwise take place for federal MDL cases
or for State Court cases that also exist in multiple states throughout
the Country. As Plaintiff attorneys we are confident in the defective
products claims being brought against Bard and Cook.
How Much Is My IVC Filter Case Worth?
Once again, any settled case will be resolved on its individual merits. We at
Queller, Fisher, Washor Fuchs & Kool do not currently plan to bring any case as part of a "class action."
Negotiations to resolve any particular IVC Filter case are based on what
a jury would be theoretically willing to award you if your personal case
went to trial. As such, as in any personal injury case, the value of your
case would depend upon your particular injury and damages. Some of the
factors that will likely be considered in determining the damages in particular
IVC filter cases include:
- the extent of the injury caused by the IVC filter, and whether your injuries
- the amount of past and future pain and suffering associated with the particular injury
- whether the injury caused or will cause past or future lost earnings or
other economic loss
- the amount of past and/or future medical expenses
- whether the IVC filter was ultimately retrieved
- whether the IVC filter is capable of retrieval
- regardless of whether the filter was retrieved or is retrievable, whether
a fracture or break of the device has already occurred, and if so whether
the shard or piece that has broken or splintered off can be located and/or
removed from the body
- in a death case, the losses suffered by the surviving family members as
a result of the wrongful death, including but not limited to actual economic
losses, and if the decedent had children, the economic value of the loss
of parental guidance of the children
What Proof or Authority Exists Regarding the Defective Nature of Bard and
Cook IVC Filters?
There are five IVC filter models that are most often associated with IVC
filter lawsuits. For Bard these include 1) The Bard Recovery Filter, 2)
The Bard G2 Filter, and 3) The Bard G2 Express Filter. For Cook the most
troublesome models have been the 1) The Cook Gunther Tulip Filter, and
2) The Cook Celect Filter. Other filters that have been known to cause
complications include the Bard Eclipse, Bard Meridian, and Bard Denali filters.
One of the most important aspects in determining whether the benefits of
a medical device outweigh the risk of implanting one is whether the device
works. In other words the benefits or efficacy of the device. There are
serious doubts about whether IVC filters have any proven efficacy.
The Inferior Vena Cava Filter, "How Could a Medical Device Be So Well
Accepted Without Any Evidence of Efficacy? JAMA Intern Med. V. 173 (No. 7) 493 (April 8, 2013).
-Decousis, et al,
A Clinical Trial of Vena Cava Filters In the Prevention Of Pulmonary Embolism
In Patients With Deep-Vein Thrombosis, N. Eng. J Med. V. 338 No. 7 409 (1998).
Eight-year follow-up of Patients With Permanent Vena Cava Filters In Prevention
of Pulmonary Embolism, Circulation v. 112 No. 3 416 (March 3, 2005).
-Billet, et al,
Efficacy of Inferior Vena Cava Filters In Anticoagulation Patients, J. Thrombosis and Hemostasis 5: 1848-1853 (June 18, 2007).
Indications, Complications, and Management of IVC Filters, JAMA Intern Med. (2013). (In this 952 patient review from 2003 to 2011
the authors noted that "48% of VTE [Venous Thromboembolism] events
were in patients without VTE at the time of the filter placement."
It can be extracted from this information that IVC filters cause venous
blood clots and should not be used in patients due to the fact that they
cause high rates of venous blood clots.
-Hemmila, et al,
Prophylactic Inferior Vena Cava Filter Placement Does Not Result in a Survival
Benefit for Trauma Patients, Annals of Surgery (October 2015). (The authors noted that despite the
prevalence of placement of IVC filters in trauma patients there exists
little data on the efficacy of doing so, and concluded that "High
rates of prophylactic IVC filter placement have no effect on reducing
trauma patient mortality and are associated with an increase in DVT (Deep
Vein Thrombosis) events."
IVC Filters and Gastric Bypass Surgery
IVC filters are often implanted as a prophylactic measure in Gastric Bypass
Patients. In a study of 542 patients who had prophylactic implant of IVC
filters, the authors concluded that "Prophylactic IVC filters for
gastric bypass surgery do not reduce the risk of pulmonary embolism and
may lead to serious complications." The authors also stated that
"Despite the increasing use of IVC filters inthe United States the
scientific literature demonstrating their effectiveness is lacking".
Birkmeyer, et al,
Preoperative Placement of IVC Filters and Outcomes after Gastric Bypass. Annals of Surgery, August 2010.
BARD IVC FILTERS
Bard has been the focus of NBC News Reports:
Specifically, with respect to Bard IVC Filters, certain internal documents
from Bard became public in a trial in Nevada in 2015. The documents strongly
suggest that Bard employees and/or policy makers discussed and/or knew that:
- Patients could be influenced by ease of use, low profile and aggressive
marketing despite the absence of a solid clinical history and despite
documented negative clinical experiences.
- We (Bard) knew very little about the long term clinical performance of
IVC Filters when they launched the product and after a year of commercialization
Bard itself admitted that there were still many questions that need to
- That the existing literature [was] of poor quality, with insufficient randomized
controlled trials (RCT) to definitively establish that IVC filters are
- That reports of death, filter migration, TVC perforation, and filter fracture
associated with the Bard Recovery filter were seen in a database known
as MAUDE (Manufacturer and User Facility Device Experience Database) at
reporting rates that were from 4.1 to 5.3 times higher than reporting
rates for all other filters and that this differential in rate of adverse
events was statistically significant.
It appears that the initial Bard predicate device known as the Simon Nitinol
Filter (SNF) was much safer than the subsequent devices, that Bard knew
this, and knew that complaints regarding injuries from subsequent models
increased substantially with the subsequent models but Bard nevertheless
continued to market the more dangerous products.
In addition to the internal documents, extensive medical literature dating
from the year 2002 shows data revealing that the Bard Recovery Filter
and Bard G2 Filter present an unacceptable risk of harm to the patients
receiving implants of such devices. Some examples of the relevant medical
literature re Bard IVC Filters:
Recovery Vena Cava Filter: Experience in 96 Patients, Cardiovasc. Interv. Radiol. (2006) 29:559-564 (which describes Bard Recovery
as being associated with "structural weakness and high incidence
of IVC wall penetration"-and which reports a 7% fracture rate and
27% perforation rate of said IVC Filter.
Comparison of the Recovery and G2 Filter as Retrievable Inferior Vena Cava Filters, J. Vasc. Interv. Radiol. (2009) 20:1193-1199 (9% fracture rate of the
Bard Recovery IVC Filter).
Stavropoulos, Oh, et al,
Removal of Retrievable Inferior Vena Cava Filters with Computed Tomography
Findings Indicating Tenting or Penetration of the IVC Wall. (Bard filters had the vast majority of perforations of the vessel all
with engagement of adjacent organ structures-with data showing a 30% fracture
rate for the Bard Recovery Filter).
Hull, et al,
Bard Recovery Filter: Evaluation and Management of Vena Cava Limb Perforation,
Fracture and Migration, J. Vasc. Interv. Radiol. (2009) 20:52-60 (The authors reported a 21%
rate of fracture with Bard Recovery and concluded that, over time, perforation
of the vessel is progressive and patients require greater imaging and
follow up care to monitor the filter).
Nicholson, et al,
Prevalence of Fracture and Fragment Embolization of Bard Retrievable vena
Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, Arch. Intern. Med. (2010) 170 (20):1827-1831. (whereby the author reports
a 12% rate of fracture for the Bard G2 Filter and a 25% rate of fracture
for the Bard Recovery Filter).
Angel, et al,
Systematic Review of the Use of Retrievable Inferior Vena Cava Filters, J. Vasc. Interv. Radiol. (2011) 22: 1522-1530 (reporting that the Bard
G2 filter accounted for 84% of all reports of IVC filter fracture to the
FDA, 59% of all reports of adverse events to the FDA, 68% of all reports
of perforations of tissue to the FDA, 68% of all reports of migrations
of IVC filters to the FDA, and 32% of all "other" reports of
IVC Filter adverse events reported to the FDA).
Zhu, et al,
Indications, Complications and Outcomes of G2 Retrievable Filters in 765
Patients: A single Institute Experience, J. Vasc. Interv. Radiol. (2010) 21:2. (Describing Bard filters as having
an "overall rate of complications including fracture, perforation,
migration and tilting of 35.4%").
Computed Tomography Evaluation of Inferior Vena Cava Bard G2 Filters, J. Vasc. Interv. Radiol. (2010) 21:2 (Discussing "prevalent findings"
of Bard "filter tilting and extension of the filter's legs or
arms into the IVC tributaries and caval wall perforation").
Tam, M. et al,
Fracture and Distant Migration of the Bard Recovery Filter: A Retrospective
Review of 363 Implantations for Potentially Life Threatening Complications, J. Vasc. Interv. Radiol. 21:2 (2011). (whereby the authors predicted,
using accepted statistical methodology, a 40% fracture rate at a point
5 1/2 years after implant).
Wood, et al,
Reporting the Impact of Inferior Vena Cava Perforation by Filters, J. Vasc. Surg. (2011) 55:1 (Which reported that the Bard G2 accounts
for 61% of the reported vessel wall perforations by IVC filters from June
2000 through 2011).
In addition, the
MAUDE Database showed that with respect to Bard's tracking of the complication rates
for each of the devices that succeeded the predicate SNF device, the later
devices consistently showed significantly increased risks associated with
each of the later devices (Recovery, G2, G2X, G2Express, Eclipse, Meridian,
and Denali) including risks of death, open heart surgery, other major
surgery, internal bleeding, migration of metal chards to the liver, lung,
heart and bowel, and a continued risk of said complications for persons
where the procedure to remove the IVC filter was unsuccessful or not attempted
due to the high risk of the procedure. These complications have been interpreted
to exceed the known rate of similar complications of the predicate SNF
device by 500% to 2000% based upon the 20 year history of the predicate device.
It appears that the subsequent Bard IVC Filters were all substantially
inferior to their own predicate Simon Nitinol Filter (SNF) device yet
upon recognizing the design problems and complications with each subsequent
device Bard nevertheless kept each such device on the market, without
even issuing additional warnings, until the next new IVC device was given
the go-ahead to proceed to market.
Cook IVC Filters
With respect to Cook IVC filters, the failure rates are similarly alarming.
It has been reported that much more often than not, perforation of the
Inferior Vena Cava vein did occur in patients with the Tulip and Celect
retrievable Cook IVC filters.
A study revealed that upon assessment of 50 patients with abdominal CT
scans, 86% of filters showed some perforated vena cava, and 100% of these
filters perforated the vena cava after 71 days indwelling (i.e., after
Durack,Journal of Vascular and Interventional Radiology, March 2011.
In an evaluation to retrospectively evaluate the safety and retrievability
of Celect IVC filters from 2007 to 2012, it was found that 14 filters
were not removed due to either filter embedment, caval occlusion, retained
thrombus, large floating thrombus, or due to tilt greater than 15 degrees.
With filters in place 5 patients developed new pulmonary embolisms (PE).
There was a staggering 99 patients (86.1%) who experienced limb penetration.
9 patients had limb penetration into the duodenum, aorta or kidney. The
mean indwelling time of the subject IVCs was 158.1 days. Zhou, et al,
Retrospective View of 120 Celect Vena Cava Filter Retrievals: Experience
at Single Institution., J. Vasc. Interv. Radiol. Dec. 2012.
In a study of 91 patients with Serial CT scan review at 75 days, 316 days,
and 554 days mean, 36% showed IVC perforation at 75 days, 71% at 316 days,
and 79% at 554 days. The authors concluded that "Celect IVCF primary
strut perforation is progressive over time." The authors proposed
that the decreasing caval area after primary strut perforation was the
mechanism for progressive perforation. Dowell, et al,
Celect Inferior Vena Wall Strut Perforation Begets Additional Strut Perforation. J. Vasc. Interv. Radiol. Oct. 2015.
Zhou, et al,
Penetration of Celect Inferior Cava Filters: Retrospective Review of CT
Scans in 265 Patients, J. Vasc. Interv. Radiol. March 2014. The purpose of this study was to
evaluate the prevalence and extent of Celect IVC filter penetration. It
was found that there was penetration of the primary leg (the primary leg
is one of the 4 long limbs or primary legs of the Celect filter-it also
has 8 arms or secondary legs) within 30 days after placement 39% of the
time. Within 90 days after placement there was penetration of the primary
leg 80% of the time. 13.2% of the filters penetrated into adjacent organs
and 10% penetrated into 2 adjacent structures.
Retrieval problems with the Celect filters are also a big issue in IVC
lawsuits. With respect to Cook Gunther Tulip and Cook Celect IVC retrieval
success it was found that upon 121 retrieval attempts there was a 24%
retrieval failure and that retrieval failure increased over time (over
117 days). In a separate study comparing 99 Cook Celect filters to 88
obviously safer IVC filters made by Rex Medical called the Option retrievable
IVC it was found that with retrievals attempted after 2 months 43% of
Celect filters perforated whereby zero percent (0%) of the Option filters
In an analysis of Tilt of the Cook Gunther Tulip filter it was found that
91% of Gunther Tulip Filters tilted (159 tilted filters out of 175 patients).
In a French Study published in the Journal of the American Medical Association (JAMA) in 2015 entitled
Effect of a Retrievable IVC Filter Plus Anticoagulation Alone on Risk of
Recurrent Pulmonary Embolism, all of the patients were anti coagulated but only 193 had IVC filters
in place. There was double the incidence of death in patients with filters
compared to patients without filters (6 filter patients died due to a
fatal PE). "These findings do not support the use of this type of
filter in ptients who can be anti coagulated".
In a study comparing Cook and Greenfield filters, the study showed that
the Cook select perforated 49% of the time (277 days mean), the Cook Tulip
perforated 43% of the time (437 days mean) while only a single 1 Greenfield
Filter perforated (mean 286 days).
Complications of Celect, Tulip, and Greenfield Filters on CT Follow-up.
Issues Specific to the ongoing IVC Litigation against Bard and Cook
In the underlying litigation against Cook Plaintiff's attorneys have
alleged during discovery that Cook has vastly under reported the incidence
of adverse events related to the Cook IVC filters. Instead of turning
over documents relevant to said discovery demands, Cook has asked the
Court to issue protective orders in an attempt to resist turning over
the discovery the Plaintiffs attorneys claim is necessary to prove these
claims. Litigation on these issues is proceeding at this time.
In the litigation against Bard, there is a serious question that Bard forged
the signature of Kay Fuller, who had been a veteran regulatory specialist
hired by Bard as a liaison to the FDA. Reportedly, Ms. Fuller refused
to sign certain documents and Bard allegedly forged her signature in order
to get approval for an IVC Filter product that the company knew was dangerous.
The forged signature relates to the Bard Recovery Blood Clot Filter and
according to Ms. Fuller a clinical trial raised serious issues regarding
the safety of the device, and that the company also withheld test results
which they did not show her. NBC News conducted a 1 year investigation
which among other things found evidence that Bard executives fully knew
as early as 2004 of the dangers to patients who had implantation of The
Recovery IVC Filter.
Another issue in the Bard litigation is disclosure of what is known as
the "Lehmann Report." This report indicates that less than a
year after use of the Bard Recovery IVC Filter, Bard knew of device malfunctions
indicating that legs of the filter would break loose and travel to other
parts of the body. Bard hired consultant John Lehmann to write a report
comparing the fracture and migration rate of the current filter to previous
models. Lehmann found that the Bard Recovery Filter had higher complication
rates than competing models and concluded that the matter should be further
investigated. Bard's lawyers kept the document concealed to internal
Bard employees on a need to know basis. The secret was exposed when Bards
lawyers accidentally disclosed the Lehmann report during a 2012 lawsuit.
Since that time Bard has argued that the reports are inadmissible attorney
work product and that all copies possessed by Plaintiff attorneys should
be returned or destroyed. A protective order has been sought seeking declaration
that the report is attorney work product and prohibiting use of the report
at subsequent trials. At present various Court's have issued differing
rulings on whether the report is or is not admissible based on the attorney
U.S. FDA Warnings For Retrievable Vena Cava Filters
After receiving 921 adverse event reports for IVC filters since 2005, the
a warning on August 9, 2010 that the retrievable filters posed known long term risks including but
not limited to "lower limb deep vein thrombosis (DVT), filter fracture,
filter migration, filter embolization and IVC perforation." The FDA's
recommendations at that time were that "implanting physicians and
clinicians responsible for the ongoing care of patients with retrievable
IVC filters consider removing the filter as soon as protection from PE
is no longer needed."
The FDA issued another
safety memo on May 6, 2014 again citing to a myriad of adverse events and reports, and indicating
that the adverse events may bear a relationship to how long the filter
had been implanted. The FDA encouraged all physicians following up with
patients who had IVC filters remove the filter as soon as possible after
perceived protection from pulmonary embolism was needed. The agency, relying
upon a published mathematical model published in the Journal of Vascular
Surgery, went on to state that "the mathematical model suggested
that if the patients transient risk for pulmonary embolsim hs passed,
the risk/benefit profile begins in favor of removal of the IVC filter
between 29 and 54 days after implantation."
Of course, these issues with removal of the IVC filter do not address the
serious questions regarding whether such devices ever should have been
implanted at all, given the abundance of literature and science which
now suggests that the risks of such devices often far outweigh the benefits,
and whether there is little or even any benefit to implanting the defective
type IVC Filter devices in the first instance.
The FDA also issued a comprehensive
"Warning Letter" to C.R. Bard dated July 13, 2015, which among other things pointed out, in detail, how in specific IVC
cases Bard had repeatedly misidentified or misclassified adverse events
including but not limited to filing events as "malfunctions"
when they should have been reported as serious injuries and death.
How Long Is The Statute of Limitations on IVC Filter Lawsuits?
The maximum time limitations to bring lawsuits varies on a State by State
basis. These statutes of limitations exist in every state and limit the
time in which a case can be brought against a particular defendant, including
the defendants in IVC Filter Lawsuits. Also, the event or mechanism that
determines when a statute of limitations starts to run may vary according
to state. For example one state may start the statute of limitations time
running at the time a negligent act was committed, and another may only
run the limitations time starting at the time of discovery of the negligence
or discovery of the injury. If you have been injured by an IVC filter,
we will need to review the facts of your particular case in order to determine
when your statute of limitations has or will expire.