IVC Filter FAQ
What is an IVC Filter?
Inferior vena cava (IVC) filters are small, cone-shaped medical devices that are inserted into the inferior vena cava just below the kidneys. The filters are designed to capture blood clots that have broken loose from one of the deep veins in the legs before they reach the heart and lungs.
What’s the Problem?
IVC filters have been reported to break away from the implant site and travel to the heart, lungs, and other vital organs. When this happens, potentially life-threatening injuries can result. The medical literature has reported a significant statistical rate of IVC filter failure, fracture, migration and other complications.
What Complications Have Been Linked to IVC Filters?
- IVC Filter Fracture
- Perforation, Puncture or Serious Damage to the Heart, Lungs or Vena Cava
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb Deep Vein Thrombosis
- Hematoma or Nerve Injury at the Puncture Site
- Constant and Severe Pain in the Heart, Chest or Elsewhere in the Body
- Pulmonary Embolism
- And more
Has the FDA Issued a Warning on Blood Clot Filters?
In August 2010, the U.S. Food and Drug Administration (FDA) issued a warning which stated that it had received at least 921 adverse event reports associated with IVC filters since 2005. Of these reports:
- 328 involved device migration
- 146 involved detachment of device components
- 70 involved perforation of the inferior vena cava
- 56 involved filter fracture
The actual number of complications associated with IVC filters is likely much higher, as physicians and device manufacturers are not required by law to report adverse events to the FDA.
Are IVC Filters the 1st Line of Defense for Patients at Risk for Pulmonary Embolism?
The usual therapy for patients at risk for pulmonary embolism are blood thinner (anticoagulant) drugs such as heparin or Coumadin (warfarin). IVC filters are used in patients who are unable to take these types of medications, such as following gastric bypass or bariatric surgery when a person is temporarily at risk for deep vein thrombosis (DVT) and traditional blood thinners may cause serious bleeding.
How Common are IVC Filters?
Vena cava filter use has increased dramatically over the past 30 years. Tens of thousands of patients in the U.S. receive IVC filters each year. In 1979, about 2,000 IVC filters were implanted; that number jumped to 167,000 by 2007; over 250,000 were implanted in 2012. Leading IVC filter manufacturers include C.R. Bard, Cook Medical and the Cordis Corporation.
How Long Should Retrievable Blood Clot Filters Remain in Place?
According to a quantitative decision analysis issued by the FDA in May 2014, if a patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.
How Many Brands of IVC Filters are there?
Our lawyers are accepting potential lawsuits for people who were injured by the following types of IVC filters:
Bard IVC Filter
- G2 X
- G2 Express
B. Braun IVC Filter
- Tempofilter II
- VenaTech LGM
- VenaTech LP
Cook IVC Filter
- Gunther Tulip
- (Rex Medical) Argon Medical OptionELITE IVC Filter
- ALN IVC Filter
- Cordis OptEase IVC Filter
- Crux Vena Cava Filter
Why Did Bard Continue Marketing its IVC Filters After Reports of Death, Complications?
Confidential records obtained by NBC News indicate that Bard was concerned about failure reports associated with the G2 series blood clot filter, which was designed to replace its Recovery filter, within 4 months of the device receiving approval from the FDA. However, instead of issuing a recall for the G2 and virtually identical G2 Express, Bard kept marketing them for 5 years, until 2010, selling over 160,000 of the devices. At least 12 deaths and hundreds of complications have been linked to the G2 series filters, according to the FDA.
Did a Forged Signature Help get Bard Recovery Filter Approved?
In 2002, Bard recruited veteran regulatory specialist Kay Fuller to help secure FDA clearance for the Recovery IVC filter after the agency rejected an earlier application. In an interview with NBC News, Fuller said that she had serious concerns about the Recovery, and that Bard didn’t give her the safety performance results of a clinical trial. When she voiced her concerns, Bard officials didn’t seem to want to hear them.
“It was basically, you know, if you continue to pursue these questions, that I was going to be asked not to be on the team,” Fuller said. “And I was shocked.”
Is There a Multidistrict Litigation?
The U.S. Judicial Panel on Multidistrict Litigation (JPML) in October 2014 consolidated IVC lawsuits filed against Cook Medical in 11 districts into a multidistrict litigation (MDL) in the Southern District of Indiana. The number of complaints filed against Cook has since grown to over 100.
In August 2015, all federal lawsuits alleging injuries from Bard IVC filters were consolidated into another MDL in the U.S. District Court of Arizona before Judge David Campbell. JPML noted that the complaints “involve common factual questions arising from allegations that defects in the design of Bard’s retrievable inferior vena cava filters make them more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing injury.” More than 50 complaints are currently pending in that litigation.
Has a Class Action Been Filed?
At least 3 separate IVC filter class action lawsuits have been filed against C.R. Bard in Florida, California and Pennsylvania state courts. The complaints state that patients who were implanted with Bard Recovery, G2 and G2 Express IVC filters that have not yet fractured or migrated will require intensive medical monitoring due to the company’s negligence, misrepresentation and concealment of data. The suits further contend that said patients make up a class which should be compensated for medical monitoring expenses. Formation of a class in this complaint has not yet been approved.
What are IVC Filter Lawsuits Alleging?
Most patients file IVC filter lawsuits for severe pain or significant injuries they suffered after receiving the device, which they claim was defective or unreasonably dangerous or failed to perform as marketed. In most states, the legal claims that may be brought include negligence, strict liability for design defect, strict liability for manufacturing defect, strict liability for failure to warn and breach of warranty.
What Damages am I Eligible to Recover?
If you were injured by an IVC filter and decide to file a lawsuit, you may be eligible to receive compensation to assist with medical expenses, lost wages, pain and suffering, and more. Your spouse may also be entitled to an award if he or she has a loss of consortium claim.
If the manufacturer’s conduct is determined to be egregious, you may also be entitled to punitive damages in certain states. In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.
How Long Do I Have to File a Claim?
Each state has a specific statute of limitations regarding the amount of time plaintiffs have to file a lawsuit over injuries allegedly caused by medical devices. If the complaint is not filed within this designated time frame, injured parties will be unable to file a lawsuit seeking compensation for their injuries. If you’ve been injured by an IVC filter, you should act now and contact our lawyers to protect your legal rights.