IVC Filter Lawsuit
What’s the Problem?
Retrievable inferior vena cava (IVC) filters are implanted into the veins of patients who are unable to take blood thinner medications in order to prevent blood clots from traveling to the lungs (pulmonary embolism). The devices intercept clots in the bloodstream and, over time, the clots break down. However, the U.S. Food & Drug Administration (FDA) has received thousands of adverse reports associated with retrievable IVC filters.
In August 2010, FDA issued a Safety Communication regarding adverse events associated with retrievable IVC filters. At the time of the warning, the agency had received at least:
- 921 device adverse event reports involving IVC filters
- 328 reports of device migration
- 146 embolizations (detachment of device components)
- 70 reports of perforation of the IVC
- 56 filter fractures
Some of these reports led to adverse complications in patients, and may have been related the devices being left implanted for long periods of time, beyond the time when the blood clot risk has passed, according to the FDA.
IVC Filter Studies
An April 2013 study published in JAMA Internal Medicine looked at complications associated with IVC filter placement in 952 patients. About 680 patients were implanted with retrievable vena cava filters, and only 58 were successfully removed. Doctors made 13 unsuccessful removal attempts, 11 of which occurred in patients whose filters had remained in place for over 85 days.
Of the 13 unsuccessful IVC filter removal attempts:
- 8 patients couldn’t have their filters removed because they were embedded;
- 3 patients couldn’t have their devices removed because the filters had punctured a blood vessel;
- 2 patients’ filters had migrated to a position that wouldn’t allow for removal, and
- 1 patient had a blood clot inside the filter.
In June 2015, a study published in the Journal of Vascular Interventional Radiology found that the Cook Celect IVC filter had a 43% rate of perforation compared to the Option filer made by Rex Medical, which had a 0% perforation rate. The researchers noted this was a “significantly higher rate” of perforation.
Another study published in the Annals of Surgery in October 2015 found that patients who suffer traumatic injuries face a “life-threatening” risk for blood clots, but that IVC filters don’t provide a survival benefit. For the study, researchers looked at 803 patients who received an IVC filter after a traumatic event between 2010 and 2014. They found that not only did the IVC filter recipients fail to receive a survival benefit, but they also suffered deep vein thrombosis (DVT) events at an increased rate. Trauma patients are being implanted with IVC filters at increasing rates despite a lack of proof that the devices help, the researchers concluded.
IVC Filter Complications
- 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
IVC Filter Brands
Our attorneys are reviewing potential lawsuits for people who were injured after receiving 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
How Long Should Retrievable Filters be left in Place?
On May 6, 2014, FDA announced that it had developed a quantitative decision analysis using publicly available data to determine how long retrievable vena cava filters should be left implanted before the risks outweigh the benefits. The results, which were published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2013, suggested that if the 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.
Report Finds Bard Knew of IVC Filter Risks
Less than a year after the Bard Recovery IVC filter was approved by the FDA in 2002, the company began receiving complaints of the devices shattering and migrating inside patients’ bodies. In 2004, Bard hired independent consultant Dr. John Lehmann to compile a report that compared the fracture and migration rates of the Recovery filters to earlier models.
Lehmann concluded that the Recovery had higher complication rates higher than competing models, and that additional research was needed to further investigate the risk. Bard lawyers distributed copies of Lehmann’s report to company employees on a need-to-know basis, and stated that the information should be kept secret.
The first lawsuits filed over injuries allegedly caused by Bard IVC filters were filed in California and Pennsylvania state courts in 2012. In October 2014, a panel of federal judges 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 February 2015, C.R. Bard settled a lawsuit filed on behalf of Kevin Phillips just 10 days after the trial began. According to the complaint, a Bard Recovery IVC filter shattered inside Phillips’ body and one of the metal struts perforated his heart. The perforation required open heart surgery and a lengthy recovery.
Bard IVC filter lawsuits were consolidated into an MDL in the U.S. District Court of Arizona in August 2015. More than 50 complaints are currently pending in that litigation. A number of lawsuits filed over other IVC filter brands are also now pending in various state and federal courthouses across the U.S.
Has a Class Action Been Filed?
At least 3 separate class action lawsuits have been filed over injuries allegedly caused by Bard IVC filters in Florida, California and Pennsylvania state courts. The class actions state that plaintiffs who received the company’s Recovery, G2 and G2 Express IVC filters that have not fractured or migrated will require intensive medical monitoring due to Bard’s negligence, misrepresentation and concealment of data. Plaintiffs further allege that each patient who received a Bard IVC filter make up a class which should be compensated for medical monitoring expenses. Courts have not approved the formation of a class in this complaint yet.
IVC Filter Timeline
2002 – Approved by the FDA
Bard Recovery IVC filter approved by the U.S. Food and Drug Administration (USFDA).
2004 – Independent report published
Independent consultant Dr. John Lehmann issues a report indicating that the Bard Recovery filter has higher fracture and migration rates than competing models. Bard chooses to keep this information hidden from the public.
2012 – First lawsuits filed
First lawsuits filed over injuries allegedly caused by Bard IVC filters filed in California and Pennsylvania state courts.
2013 – JAMA Internal Medicine Study Published
Study published in JAMA Internal Medicine investigates IVC filter complications in 952 patients. About 680 patients received retrievable filters, and only 58 were successfully removed.
2013 – Journal of Vascular Surgery quantitative decision analysis published
Quantitative decision analysis published in the Journal of Vascular Surgery which suggests that IVC filters should be removed 29-54 days after implantation, if pulmonary embolism risk has passed.
2014 – FDA issues Safety Communication
FDA issues Safety Communication regarding Journal of Vascular Surgery study results.
2014 – Lawsuits filed
Lawsuits filed over injuries allegedly caused by Cook IVC filters consolidated into a multidistrict litigation (MDL) in the Southern District of Louisiana.
2015 – C.R. Bard settles
C.R. Bard settles a lawsuit filed by Kevin Phillips 10 days after the trial begins. According to the complaint, a Bard Recovery IVC filter shattered inside Phillips’ body and one of the metal struts perforated his heart, requiring open heart surgery and a lengthy recovery.
2015 – Journal of Vascular Interventional Radiology study published
Study published in the Journal of Vascular Interventional Radiology finds that the Cook Celect IVC filter had a 43% rate of perforation compared to the Option filer made by Rex Medical, which had a 0% perforation rate.
2015 – Lawsuits consolidated into an MDL
Bard IVC filter lawsuits consolidated into an MDL in the U.S. District Court of Arizona.
2015 – Annals of Surgery study published
Study published in the Annals of Surgery finds that people who suffer traumatic injuries face a “life-threatening” risk for blood clots, and that IVC filters don’t give them a survival benefit.
2015 – NBC News investigation
NBC News investigation reveals that C.R. Bard may have known about the risk of complications with its Recovery IVC filter before the company received approval to market it.
- “Removing Retrievable Inferior Vena Cava Filters: Initial Communication”. U.S. Food & Drug Administration (FDA). August 9, 2010.
- “Indications, Complications, and Management of Inferior Vena Cava Filters The Experience in 952 Patients at an Academic Hospital With a Level I Trauma Center”. JAMA Internal Medicine. April 8, 2013.
- “Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism”. Journal of Vascular Surgery: Venous and Lymphatic Disorders. October 2013.
- “Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication”. U.S. Food & Drug Administration (FDA). May 6, 2014.
- “A Comparison of Retrievability: Celect versus Option Filter”. Journal of Vascular Interventional Radiology. June 2015.
- “Prophylactic Inferior Vena Cava Filter Placement Does Not Result in a Survival Benefit for Trauma Patients”. Annals of Surgery. October 2015.
- “Why Did Firm Keep Selling Problem Blood-Clot Filters?”. NBC News. December 31, 2015.