Our attorneys are recognized as leaders in New York product liablity trial law. Six of our attorneys have achieved AV Preeminent status with Martindale-Hubbell representing the highest ranking for ethical standards and legal ability. Five of our attorneys have been featured as Super Lawyers in the New York Metropolitan Area as published in the Magazine Section of the New York Times. Our firm is ranked among the Best Lawyers in the State of New York and is ranked among the Best Law Firms in the New York Metro area by US News & World Report in the field of medical malpractice law.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 to prevent)
- causing injury to the heart and lungs
- causing other serious injury, including stroke and death
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
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 are permanent
- 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
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.
Editorial, 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).
PREPIC, 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).
Sarosiek, 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 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 be answered.
- That the existing literature [was] of poor quality, with insufficient randomized controlled trials (RCT) to definitively establish that IVC filters are effective.
- 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:
- Kalva, S., 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.
- Cantwell, C., 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%").
- Cura, M., 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 implant). See 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 perforated.
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 work-product doctrine.U.S. FDA Warnings for Retrievable Vena Cava Filters
After receiving 921 adverse event reports for IVC filters since 2005, the FDA issued 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.