IVC Filter Cases
Ongoing civil litigation seeks compensation for patients who have suffered devastating complications from an implanted IVC filter. IVC filter cases involve hundreds of patients who had a retrievable medical device placed to prevent pulmonary embolisms. A majority of the claims are being filed against two companies, C.R. Bard and Cook Medical, the manufacturers of several retrievable products that are implicated in widespread complications, going back several years.
The specific brand names of the devices involved include:
- Bard Recovery IVC Filter (withdrawn in 2005)
- Bard G2 IVC Filter
- Bard G2 Express or G2X Filter
- Bard Eclipse
- Bard Meridian
- Cook Gunther Tulip
- Cook Celect
Who is Affected by the IVC Filter Lawsuit?
Plaintiffs involved in this litigation had an IVC filter implanted in 2003 or later, and suffered one or more adverse complications. In some cases, patients have died as a result of IVC filter failures, and their family members have filed wrongful death suits. If you or a loved one suffered complcations from an IVC filter, please contact an experienced attorney today to protect your legal rights.
IVC filter lawsuits allege that Bard and Cook failed to properly warn healthcare providers and patients about the known risk of complications, and the need to remove the devices within a specified timeframe.
IVC filters are commonly recommended as a preventive treatment method for patients who are at risk for deep vein thrombosis (DVT). The retrievable IVC filter is a cage-like device that resembles a small (1.5”) spider made of metal. It is implanted in the inferior vena cava (IVC), the primary vein that brings blood from the lower extremities to the heart. The filter is designed to trap blood clots in the vein and prevent them from migrating and blocking blood flow to the lungs, a potentially fatal event.
Candidates for a removable IVC filter may have had recurrent DVT events or may have been at a higher risk for blood clots after surgery or serious injury. Doctors will occasionally recommend an IVC filter instead of anticoagulant medication for patients who don’t respond well to blood thinners or are considered to be at risk for uncontrolled bleeding. This may include patients hospitalized after a car accident, spinal cord injury, or emergency surgery for a traumatic wound. Cancer treatment, dialysis, or hip replacement patients may also be susceptible to formation of clots, but risk suffering complications from blood thinners.
Injuries Leading to Court Cases
Common complications seen in IVC filter cases include hemorrhaging, organ damage, DVT, pulmonary embolisms, and strokes. There have been many life-threatening injuries reported, as well as more than two dozen IVC filter-related fatalities.
IVC filter lawsuits allege that Bard and Cook failed to properly warn healthcare providers and patients about the known risk of complications, and the need to remove the devices within a specified timeframe. Although the retrievable IVC filter is meant to be a temporary therapy, the device is often left inside the patient’s body for extended periods, resulting in greater difficulty to remove the filter.
An study in the October 2013 Journal of Vascular Surgery found that “50% or fewer of retrievable IVC filters are ever removed…”, and that the risk of complications “would be expected to increase with the duration of implantation.” The report also noted widespread off-label use of IVC filters beyond what the U.S. Food and Drug Administration (FDA) has indicated its use for, which accounts for more than 50% of implantation procedures.
If you have been injured by a defective medical device, Speak with an Attorney
In 2014, the FDA released an alert to physicians warning that IVC filters should be removed between 29 and 54 days after placement. The communication cited a study showing that the risk of complications outweighs the potential benefit to patients after 54 days. This FDA warning was a follow-up to a 2010 alert, which reported more than 900 adverse events related to these devices, including 146 pulmonary embolisms. They cited 70 filter perforations, 328 device migrations, and 56 product fractures. The panel recommended removal of the filter as soon as patients are out of immediate danger for blood clots.
There are allegations that Bard knew about the dangers prior to releasing their first IVC filter, and suppressed their own research to hide evidence implicating the products they were selling. Bard is also being accused of forging a signature on documents to obtain FDA approval for their device.
Illustrative Cases
Over 340 individual plaintiffs are currently participating in litigation against Bard or Cook, and many more are anticipated. The lawsuits allege several claims, including negligence, failure to warn, liability for design defects, breach of implied warranty, failure to recall, fraudulent misrepresentation, and concealing evidence.
In February 2015, C.R. Bard settled an IVC filter case, the first to reach resolution. This lawsuit, filed by Kevin Phillips in Nevada, involved the Bard Recovery filter, which was found to have broken inside the plaintiff’s body. One of the metal struts migrated to his heart and caused a perforation, requiring open heart surgery followed by a lengthy recovery period. Mr. Phillips and Bard reportedly agreed to a confidential settlement 10 days into trial.
In March, 2015, Larry and Brenda Johnson filed a pending case against Cook Medical. Mr. Johnson’s implanted Celect filter apparently fractured and migrated to his heart. He lost consciousness while driving, and seeks compensation from the incident and subsequent multiple surgeries.
Another case, filed in September, 2015, involves a wrongful death allegation by a woman in Missouri, whose husband died from complications of a blood clot. He had been treated with a Bard G2 IVC filter to prevent migration of a potentially deadly clot, but doctors discovered his filter had tilted and perforated his vena cava, rendering it ineffective.
A very recent case filed in January 2016 concerns a South Dakota woman who underwent implantation of the Bard Eclipse IVC filter in October of 2012. A year and a half later, doctors discovered her filter had migrated and was embedded in her internal organs. The plaintiff’s doctor said he was unable to remove the filter without risk of causing her additional harm, and she is alleging damages that include bodily injury, disability, impairment, disfigurement, and emotional and psychological trauma.
In February 2016, two class action lawsuits against Cook Medical were filed in Canada. In one case, a woman must take blood thinners indefinitely because her Cook filter, which was implanted in 2013, fractured.
Multidistrict Litigation
Most of the lawsuits filed against C.R. Bard and Cook Medical have been consolidated into two multidistrict litigation (MDL) cases. MDL is an alternative to class action lawsuits, and can be a better option for many plaintiffs. Class action lawsuits award damages pertaining to a small group of plaintiffs, and the outcome is legally binding for all plaintiffs involved. MDL plaintiffs remain independent, though the lawsuits are combined under one judge. MDLs, which can include individual and class-action parties, are efficient for cases with multiple plaintiffs with similar concerns, and can expedite the legal process.
As of February 15, 2016, the Bard MDL case included 84 individual cases centralized in Arizona. The Cook Medical MDL contained 255 claims overseen by the Southern District Court of Indiana. These cases originate from states all over the country, with a number of attorneys representing individual plaintiffs.
Have You Suffered from Implantation of an IVC Filter?
If you or a loved one has suffered an adverse complication while using an IVC filter, you may be entitled to compensation. Patient damages can include medical expenses, lost wages, pain and suffering, and more.
Be sure you understand your legal options so you can make an informed decision. Compensation cannot right a wrong, but it can help you heal and rebuild your life. To schedule a complimentary consultation, please contact a product liability attorney today.