Retrievable Inferior Vena Cava (IVC) filters are intended for use in catching blood clots before they can travel to the lungs. But reports to the FDA describe hundreds of adverse events suffered due to IVC filters resulting in serious medical complications or death.
The vena cava is the largest vein in the human body. The inferior vena cava is the lower portion of this vein and carries de-oxygenated blood from the lower half of the body back to the heart. Blood clots can form in deep veins in the body, most often those of the legs or thigh, and are known as deep vein thromboses (DVTs). Clots can travel from a DVT to the lungs, causing a pulmonary embolism, the name for a blockage in an artery in the lungs, which can cause death.
DVT is most frequently treated with anticoagulant drugs to dissolve blood clots. IVC filters may be used in cases where patients cannot tolerate anticoagulation drugs or where anticoagulants are ineffective in treating DVT in a patient.
IVC filters are cage-like devices that are inserted into the inferior vena cava with the intention of capturing blood clots and preventing them from traveling.
Some IVC filters are intended to remain in the vein permanently. Retrievable IVC filters, however, can be removed.
If you have suffered an injury from a retrievable IVC filter, you may be entitled to compensation for medical expenses or other compensation. Weitz & Luxenberg may be able to help you, beginning with a free consultation.
Complications from Retrievable IVC Filter Problems
The U.S. Food and Drug Administration (FDA) now recommends retrievable IVC filters be removed “as soon as protection from pulmonary embolism is no longer needed.”
From 2005-2010, the FDA received 921 reports of problems with IVC filters. These included:
Fracturing of the device
Migration of the device
Perforation of the IVC
Organ damage due to detachment of IVC filter components
If you or a family member experienced complications after having a retrievable IVC filter implanted, you may benefit from talking to an experienced attorney to help determine your legal options.
Weitz & Luxenberg has three decades of experience in complex device-related litigation and has been instrumental in settlements and verdicts worth billions for thousands of people harmed by medical devices.
Hundreds of lawsuits have been filed against the manufacturers of retrievable IVC filters, with many cases combined into multidistrict litigations (MDLs). MDLs combine multiple lawsuits for the purpose of discovery and pre-trial practices, potentially saving time and money, and often allowing cases to move more quickly through the legal process.
The MDLs involve two manufacturers of retrievable IVC filters: Cook Medical and Bard Peripheral Vascular, Inc. (whose parent company is C.R. Bard).
Some Cook Medical retrievable IVC filters include:
Cook Günther Tulip
Bard models include:
G2 Express (G2X)
Other manufacturers’ retrievable IVC filters include:
ALN Optional retrievable IVC filter
Argon Option ELITE retrievable IVC filter
Cordis OPTEASE retrievable IVC filter
If you or a family member suffered from complications after being implanted with a retrievable IVC filter, you may be entitled to compensation. Weitz & Luxenberg may be able to help, starting with a free consultation.
News Report Cites Retrievable IVC Filters in 39 Deaths
In late 2015, NBC News cited “confidential company records” in a series of reports alleging C.R. Bard kept some retrievable IVC filter models on the market for five years after discovering the devices had fatal design flaws.
The network, citing an analysis of FDA and Bard records, reported that the company’s Recovery model was associated with 27 patient deaths. Bard never recalled the Recovery filter, instead replacing the model with the G2 series in 2005, only three years after the Recovery had first been introduced to the market. NBC reported the G2 series was associated with another 12 deaths by 2015, and that the first reports of failures similar to those seen with the Recovery filter appeared as early as four months after the G2 filters had been introduced to the market.
For a free consultation and more information about your legal options, please contact us today.
When Bard sought to bring the G2 and G2 EXPRESS filters to the market in 2005 and 2008, respectively, Bard listed its Recovery filter as the predicate device in the applications for both device approvals. The Recovery was the first IVC filter to have retrieval indication in the U.S., though not originally approved for optional retrieval until 2003. The later G2X was given a “retrieval hook” in its design for what the company called “multiple retrieval options.”
NBC cited a confidential study Bard commissioned that examined adverse events reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The study reportedly found Bard’s Recovery filter device “had higher failure rates of relative risk for death, filter fracture and movement than all of its competitors.” The doctor who conducted the study said further investigation into the device’s fracturing and migration was “urgently warranted.”
Government Agencies Take Action on Retrievable IVC Filters
One report to the FDA in 2007 detailed how a patient implanted with a Recovery IVC filter died after the filter came loose and lodged in the patient’s heart. An autopsy “revealed the entire filter had migrated and was enmeshed in the tricuspid valve, encased in thrombus, and the pulmonary arteries were extensively distended and occluded with blood clot.”
In 2010 the FDA issued an Initial Communication regarding the removal of retrievable IVC filters and then a Safety Communication in 2014, saying it was “concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.” The agency recommended doctors remove retrievable IVC filters from patients as soon as possible when they were no longer needed.
In 2015, the FDA sent a warning letter to Bard’s Chairman and CEO Timothy M. Ring after inspectors found violations at the company’s facilities in Tempe, Arizona, and Queensbury, New York.
The FDA first and foremost noted in its letter that Bard was manufacturing a “Recovery Cone Removal System” without marketing clearance or approval from the agency, meaning the device was adulterated and in violation of federal law. The device was labeled as a tool intended for removal of the company’s Recovery, G2, and G2X retrievable IVC filters.
In 2016, Canada’s medical device regulatory agency, Health Canada, issued a notice to healthcare professionals and consumers warning of “Risk of Serious Complications” from IVC filters. The agency cited reports of serious complications, many of which occurred in people who had the devices implanted for more than 30 days – what the agency considered long-term filter implantation.
In its statement, Health Canada said that as of the date of the publication of the alert in 2016 it had received 121 reports of serious complications associated with IVC filters. It listed 12 models, both permanent and retrievable, made by six companies, affected by its announcement. These included Bard’s G2 and Denali models and the Cook Celect and Gunther Tulip models.
The Health Canada statement said “Healthcare professionals should carefully consider the indications for IVC filters” and echoed the FDA’s Safety Communication that the devices “should be removed when anticoagulation therapy can be started or if a patient’s risk of PE [pulmonary embolism] subsides.”
Studies: Risks for Bard Retrievable IVC Filters
Years before the FDA and Health Canada recommendations, some studies of retrievable IVC filters had documented complications occurring with these devices.
Complications included filter fracture, tilting, caudal migration, and leg penetration. One study published in 2010 in JAMA Internal Medicine concluded both Bard Recovery and G2 filters “had high prevalences of fracture and embolization, with potentially life-threatening sequelae.”
Study: Perforation, Fracture, Embolization from Cook Retrievable IVC Filters
Multiple studies have found problems with IVC filters breaking, puncturing veins, and other potentially serious problems related to the devices.
“Perforation of the IVC: Rule Rather Than Exception After Longer Indwelling Times for the Günther Tulip and Celect Retrievable Filters”
In one study first available online in 2011 from the journal CardioVascular and Interventional Radiology entitled “Perforation of the IVC: Rule Rather Than Exception After Longer Indwelling Times for the Günther Tulip and Celect Retrievable Filters” researchers found perforation “of at least one filter component through the IVC was observed in 43 of 50 (86%)” of these filters and recommended “filter retrieval as early as clinically indicated and increased attention to the appearance of IVC filters on all follow-up imaging studies.”
In 2015, researchers looking into the difficulty of retrieving certain IVC filters discovered a high rate of blood vessel perforations by Cook Celect retrievable IVC filters.
They examined filter retrieval procedures of 99 people implanted with the company’s Celect model compared to 86 patients implanted with Rex Medical’s Option retrievable IVC filter. The average time patients had one of the filters implanted was slightly over two months.
The researchers discovered that after removal, those patients implanted with the Celect model had a 43 percent perforation rate, compared to zero percent for those implanted with the Option filters.
Patients Recount Pain, Complications from Retrievable IVC Filters
Heidi Gribble Camp began suffering back pain shortly after a Cook Günther Tulip IVC filter was implanted in her IVC in 2006. By 2014, she began having bouts of nausea and experienced rapid weight loss. The doctors discovered that in the intervening years since implantation, the IVC filter had migrated and broken. A CT scan showed “[s]everal legs of the filter appeared to be sticking out of the vena cava; one was touching the duodenum, the upper section of the small intestine…” A bone spur that had formed on her spine “seemed to have been caused by the constant friction on her vertebrae from a broken piece of the filter.”
“I was panicking,” she told The Washington Post in 2016.
Fearful that a fragment of the filter could travel to her heart, she opted to remove the implant. “It was the best day of my life,” she said.
Dodi Froehlich received a Bard Recovery retrievable IVC filter in 2004 after a car accident put her at greater risk for blood clots. Just four months later, she had to be rushed to the hospital after she developed a severe headache and passed out.
Part of the device had broken off, piercing her heart. She required open heart surgery to remove the filter fragment and save her life.
Others have not been as lucky. Gloria Adams died just a week after receiving a Bard Recovery retrievable IVC filter in 2004. NBC reported her autopsy revealed that instead of stopping a clot, one had pushed the filter into her heart, puncturing her heart and killing her.
Dr. William Kuo, an interventional radiologist at Stanford Health Care’s IVC Filter Clinic, a facility that specializes in removing IVC filters, told NBC News in 2015, “The number of complications, the frequency of severe failures makes it obvious that it [the Bard G2 series] was never safe to be implanted.”
The doctor said he has removed roughly 1,000 failed IVC filters between 2005 and 2015 and that the Bard models accounted for more procedures than any other single filter manufacturer.
If you or a family member has been injured by a retrievable IVC filter, you may be entitled to compensation for medical expenses, pain and suffering, lost wages, and other costs. Discussing your situation with an attorney experienced in medical device litigation can help you understand what options are available to you.
Weitz & Luxenberg may be able to help, beginning with a free consultation.
For a free consultation and more information about your legal options, please contact us today.
In recent years, more than a thousand lawsuits have been filed over retrievable IVC filter failures. Lawsuits against Bard and against Cook have been combined in separate Multidistrict litigations (MDLs) against each company.
An MDL in Indiana’s Southern District federal court includes more than 100 lawsuits over Cook’s retrievable IVC filters.
The first bellwether lawsuit against Cook is scheduled for October 2017, with two more planned in 2018. More than a thousand lawsuits against Bard over its retrievable IVC filters have been consolidated into an MDL in federal court in Arizona.
Parties in the Arizona MDL were to select six bellwether cases in March 2017. The trial is unlikely until 2018 at the earliest.
“The FDA has determined that long-term use of retrievable IVC filters may pose dangerous risks,” Mr. Sedgh said. “And the negligent manufacturer should do the right thing and compensate those who were injured as a result of their wrongdoing.”
Mr. Sedgh was also a part of the 2014 MDL trial team that won a more than $9 billion verdict* against the manufacturers of the diabetes drug Actos. Mr. Sedgh was one of the attorneys who represented a diabetic man who developed bladder cancer after taking the drug.
Weitz & Luxenberg attorneys have also played crucial roles in MDL settlements for all injured plaintiffs resulting in a total of more than $4 billion for faulty hip implants.
If you have been implanted with a retrievable IVC filter that migrated or fractured within your body, punctured your blood vessels or organs, or caused organ damage, Weitz & Luxenberg would like to talk to you. The firm also wants to hear from people who have had a family member die of complications after being implanted with an IVC filter.
* Past performance is no guarantee of future results. The Actos verdict was reduced to approximately $38 million by the trial court on October 27, 2014. The settlements in which Weitz& Luxenberg played leadership roles included patients not represented by Weitz & Luxenberg.
Tam, M.D., et al. (2014, June). Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/22188776
An, T., et al. (2014, June). Prevalence and clinical consequences of fracture and fragment migration of the Bard G2 filter: imaging and clinical follow-up in 684 implantations. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/24656176
Nicholson, W., et al. (2010, August 9). Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and Tamponade. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/20696949
Durack, J.C., et al. (2012, April). Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filters. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21448771