Inferior Vena Cava (IVC) Filter Side Effects

Patients implanted with Inferior Vena Cava (IVC) blood clot filters have suffered severe complications when the devices broke or fractured inside their body, allegedly due to a design flaw and/or the filters being implanted for too long. The majority of IVC filter lawsuits have been filed against manufacturers C.R. Bard and Cook Medical, alleging punctured veins and organs, fractured devices, chronic health issues and life-threatening events. Most of the complaints involve the Bard Recovery and Bard 2 IVC filters, the Cook Celect IVC Filter and the Cook Gunther Tulip IVC filter..

As of December 2017, more than 6,000 IVC filter lawsuits are pending in federal court, involving 3,575 Cook IVC filters and 3,294 Bard IVC filters. Bard and Cook Medical are accused of negligence and designing defective devices.

The five devices mostly involved in the lawsuits are:

• Bard Recovery filter,
• Bard G2 filter
• Bard G2 Express filter
• Cook Celect filter, and
• Cook Günther Tulip filter

Currently there are two IVC filter multidistrict litigations (MDLS): one for lawsuits filed against Cook and another for lawsuits filed against Bard.

Lawsuits against IVC filter manufacturers accuse the companies of:

• Bringing to market unreasonably dangerous products
• Concealing knowledge of device defects and dangers
• Designing, manufacturing, and marketing defective medical devices
• Disregarding the health and safety of filter recipients to serve their own financial interests
• Failing to warn about product defects and health risks and
• Breaching their duty to act reasonably in order to prevent foreseeable patient harm

  IVC Filter lawsuits against Cook are taking place in Indiana--where Cook is headquartered. (MDL -2570 IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation). A lawsuit filed in March 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:17-cv-00762, has been centralized with the other IVC filter lawsuits now pending in the MDL. Lawyers accuse Cook Medical of downplaying side effects, selling an unreasonably dangerous device, and failing to study it for safety.

In August 2016, Judge U.S. District Judge Richard L. Young in the Southern District of Indiana picked the first bellwether cases out of hundreds of Cook IVC filter lawsuits in multidistrict litigation. The first IVC bellwether trial in October 2017 resulted in a victory for Cook in Hill v. Cook Medical, Inc., et al, 1:14-cv-6016 (Celect).
  The first Bard MDL trial is scheduled for March, 2018.
 

All federal cases against Bard have been centralized in Arizona—where Bard is headquartered. In November 2017 Bard attempted to have all charges dismissed but the judge pointed out that Bard’s IVC filters had been approved through the FDA’s 510(k) process. As of December 2017, 3,294 lawsuits remained pending in MDL-2641 IN RE: Bard IVC Filters Products Liability Litigation.

Plaintiff Ava E. Langford from Missouri (Langford et al v. C.R. Bard Inc. et al, Case No. 4:2015-cv-01749, November 24, 2015 in Missouri Eastern District Court) in her lawsuit claims that the Bard G2 IVC filter, designed to snag and hold a mobile blood clot from traveling to the lung, instead has a tendency to fracture and fail, causing damage and injury in its wake.

In December 2017 a lawsuit was filed by a man from Pennsylvania who was injured by Bard’s G2® Inferior Vena Cava Filter. Jose O. accuses Bard of manufacturing a defective device, failing to warn about side effects, designing a defective device, negligence, negligent misrepresentation, breach of implied and express warranty, and fraudulent misrepresentation. His lawsuit is centralized with the MDL in Arizona. (Case 2:17-cv-04548-DGC)

Bard IVC filter class action lawsuits, which have been filed against in Florida, Pennsylvania, and California courts, intend to establish a medical monitoring fund for all patients implanted with Bard IVC filters because they will require ongoing tests to ensure the safety of the devices. Bard’s negligence regarding IVC filters was documented in an NBC News investigation. According to NBC, dozens of deaths and hundreds of non-fatal complications are linked to the Bard Recovery and G2 filters. The investigation says that Bard knew about problems with the devices but did not pull them from the market. Instead, the company allegedly covered up the issues and continued selling the faulty G2 and Recovery filters, putting hundreds of thousands of patients at risk for potentially fatal injuries.
  In 2016 two class-action lawsuits were launched by Canadians against Cook. The plaintiffs allege the apparatuses have broken apart and become trapped inside their bodies, and left them dealing with the painful consequences, according to CTV News.

A Cook Medical inferior vena cava filter was implanted inside Wendy Kopeck, from Alberta. When she returned to hospital for the device to be removed, doctors determined it was too risky to proceed. A PET scan revealed the filter had broken, with one leg piercing her internal jugular vein and the rest of the device migrating into her small intestines. Kopeck, who must stay on blood thinners for the rest of her life, filed a $200-million class-action lawsuit against Cook Medical, alleging she was never warned of the potential risks. Arie Kuiper in Ontario filed a similar lawsuit, asking for $500,000 for each person implanted with a Cook Medical IVC filter, as well as $20 million in damages.
  Inferior vena cava (IVC) filters are used in patients who are at a risk of pulmonary embolism but cannot tolerate anticoagulant medications. These spider-like filters are tiny devices implanted in the patient's inferior vena cava (the main blood vessel that returns blood from the legs and lower part of the body to the heart), and contain struts designed to catch blood clots before reaching the patient's lung. IVC filters are intended to be retrievable, meaning a physician can remove the device after the risk of developing blood clots has subsided.

Some IVC filters have been linked to metallic failure, in which the struts break off from the filter, putting the patient at risk of perforation of major blood vessels, deadly internal bleeding, or stroke. Other life-threatening complications reportedly include device migration. If an IVC filter fractures in a patient’s body the filter, or parts of it, can migrate causing internal injuries including:

• Perforation of the heart
• Perforation of the lungs
• Cardiac tamponade (disruption of the heart caused by excess fluid)
• Hemorrhagic pericardial effusion (blood around the heart)
• Ventricular tachycardia (accelerated heart beat) and
• Puncturing of the vena cava.

  The following studies are published in the Journal of the American Medical Association (JAMA): A study in November 2017 suggests the placement of inferior vena cava filters have been on the decline since hitting a peak in 2010. That decline coincides with a warning issued by the FDA in 2010 against use of IVC filters as a long-term strategy against problematic blood clots.

In 2015 a JAMA study found that IVC filters were not as effective as blood thinners at preventing pulmonary embolism. The researchers found that filter recipients were twice as likely to have a blood clot travel to their lungs than those on blood thinners. A study published in August 2015 in a letter in JAMA warned that the long-term risks of IVC filters may negate any health benefits they provide in catching blood clots.

A study in 2013 found that, although the retrievable IVC filters are designed to offer temporary protection, many are left implanted indefinitely. Researchers concluded that use of IVC filters for certain uses resulted in "suboptimal outcomes."

CardioVascular and Interventional Radiology (April 2012) published a study that found all Cook Celect and Gunther Tulip filters showed some degree of vena caval perforation after just 71 days. The researchers found that full perforation of at least one component all the way through the IVC wall occurred in 86 percent of all cases. The researchers called for the removal of IVC filters as early as clinically indicated, and urged doctors to take a close look at IVC filters during follow-up imaging scans.

Researchers from the University of Colorado (March 2015) found that rates of IVC filter perforations were significantly higher with the Cook Celect than with competing IVC filters.

A 2014 study involving researchers from the University of Ottawa and the Ottawa Hospital Research institute found that IVC filters were "associated with a substantial rate of complications," including those relating to blood clots.

In December 2015, the Society of Interventional Radiologists, Society for Vascular Surgery and blood-clot filter manufacturers also launched a five-year study involving 2,100 patients to look at the safety and effectiveness of the devices. The massive study was also organized in conjunction with the FDA.
  In August 2010 the FDA reported 921 adverse events and product problems associated with the filters. Among the problems listed were 328 reports of device migration, 56 reports of filter fracture, 146 reports of device embolization (where the entire filter or parts of the filter move to the lungs or heart), and 56 reports of perforation of the IVC. The FDA has also noted that some reports involved difficulty removing the device.

The agency stated that the risks might be linked to retrievable filters remaining in the patient for too long. At the time, the FDA noted that physicians responsible for patients with IVC filters implanted should weigh the risks and benefits of filter removal and consider removing the filters as soon as they are no longer needed.

In 2014, the FDA said that patients may face an increased risk of problems the longer IVC filters remain in place, and advised doctors for removal between 29 days and 54 days after implantation.
  As of December 2017, Bard has settled some individual cases. Neither Bard nor Cook has announced a global settlement to resolve nearly 6,000 pending lawsuits.

A Nevada man filed a lawsuit after Bard’s Recovery Filter System implant in 2005 migrated to his heart, causing life-threatening complications requiring emergency open-heart surgery in April 2010. Ten days into the February 2015 trial, C.R. Bard settled with Kevin Philips for an undisclosed amount.

Bard settled with another plaintiff after 11 days into trial in January, 2015. Plaintiff’s attorneys showed evidence that C.R. Bard had known since 2004 that their Recovery Filter was not “reasonably safe” and exposed patients to risk of death and severe injuries. According to court documents, internal tests revealed that the filter failed to meet its own minimum safety requirements and several physician consultants expressed concern with the product’s stability: The Recovery Filter fractured at a rate 28.3 times higher than all similar devices combined. The patient’s surgeon and a Bard sales rep both testified that they would have never advocated the product had they known of these grave risks.
 

IVC Filter Legal Help

If you or someone you know has had an IVC filter implanted that resulted in any side effects mentioned above, or other serious medical complications, you may have a case for filing a claim against the manufacturer. Experienced IVC filter lawyers are currently reviewing potential claims from patients and their family members. Please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Oct-14-20