Inferior vena cava (IVC) filters were designed to protect people at high risk of blood clots from suffering a potentially fatal embolism if that clot were to travel to the lungs or heart. The idea is the device will halt the clot, which eventually dissipates.
Sometimes referred to as “blood clot filters,” IVC filters were first approved in 2002 for use by patients who couldn’t take anticoagulants or for cases in which those medications failed. At the time, the filters were heralded as a life-saving, medical-technological breakthrough.
However, it’s now become clear that for many patients, the danger far outweighs the benefits.
At the Law Offices of Jeffrey S. Glassman, our IVC filter attorneys know far too many medical product defects have led to horrible outcomes. Although these devices were created as an alternative to anticoagulants (blood-thinners), patients are only now learning the device they were told could save their lives could result in serious or life-threatening medical emergencies.
While all medications, medical devices and medical procedures carry some potential risk, many patients and doctors weren’t informed of the hazards or the importance of having retrievable IVC filters timely removed. Defects in spider-like design of the devices are alleged to have created an unreasonable risk to patients.
The most common issue is fragments of the filter break off inside the veins. Those pieces then move to the lungs or heart. The result is a pulmonary embolism or a cardiac embolism. Both are often deadly.IVC Filter Complications
- Fracture of the IVC Filter
- Internal Bleeding
- Damage to Vena Cava or Lungs
- Puncture, Perforation or Serious Damage to Heart
- Severe, Constant Pain in Heart, Chest and Elsewhere
- Nerve Injury
- Pulmonary Embolism
- Lower Limb Deep Vein Thrombosis
The largest manufacturers of these devices, C.R. Bard and Cook Group, Inc., have defiantly defended the product, even in light of growing research underscoring the problems and numerous public warnings from the U.S. Food & Drug Administration (FDA). The products in question include:
- The Bard Recovery Filter
- The Bard G2 Filter
- The Bard G2 Express Filter
- Denali IVC Filter
- Meridian Filter
- Celect Filter
- Gunther Tulip Filter
- Eclipse Filter
Since 2005, the FDA has more than 1,000 reports of serious, adverse events related to Bard IVC filters. Those include dozens of deaths. Those reports include complications related to:
- Device migration
- Emoblizations (device component detachment)
- Perforation of the IVC
- Tilting or shifting of the device inside the artery
- Filter fracture
Similar complications have been reported with filters made by Cook Medical, B.Braun, Boston Scientific and others.
Amid a growing number of lawsuits, Bard has begun settling many out-of-court. But that’s not a guaranteed outcome. Patients adversely affected by IVC filters must seek the counsel of an experienced attorney.FDA Takes IVC Filter Manufacturers to Task
In a July 2015 warning letter issued by the FDA to C.R. Bard, Inc. and Bard Peripheral Vascular Inc., the agency cited eight violations of federal law related to production and use of the IVC filters. The FDA alleged the company illegally sold adulterated and misbranded IVC filters, and then did not report the complications and adverse events to the FDA and the public, as required by law.
Among those violations:
- When regard to the Recovery Cone Removal System, Model RC-15, the company never received clearance for its release and sale – a direct violation of 21 U.S.C. § 321(h). The company had no other device to remove the filters, and it wanted to keep its edge. But doctors were never told the device wasn’t cleared.
- When it came to the G2 Filter, G2 Express Filter and Denali filter, the FDA determined Bard violated 21 U.S.C. § 820.198(a) for the way it processed complaints, investigations and reporting. The company reportedly failed to report when pieces broke off in the body and resulted in hemorrhaging and migration to the heart and lungs and other serious injuries. There were at least 10 patients who had serious complications and failed retrieval surgeries that were never reported to the FDA.
- In violation of 21 U.S.C. § 803.50(a)(2), the FDA alleged the company failed to report information it new reasonably showing its IVC filters malfunctioned and caused or contributed to serious injury or death.
- In violation of 21 U.S.C. 820.80(b), the FDA determined the Denali Filter didn’t meet its predefined acceptance criteria for function because manufacturer failed to properly test, inspect or otherwise verify that the product conformed to specified requirements.
All of this came after a 2010 FDA safety communication – updated in 2014 – warning the filters could cause adverse health effects when implanted and then left in patients for long periods of time. The agency warned the filters were only intended for short-term use, and leaving the devices in could expose patients to an increased risk of fractured implants.
In 2005, the FDA issued a Class I recall for 18,000 Stainless Steel Greenfield Vena Cava Filter made by Boston Scientific. That recall concerned devices made prior to March 2004.
So far, no other recalls have been initiated, but there have been numerous studies outlining the potential dangers.
In 2015, research published by the Journal of the American Medical Association revealed the risk of pulmonary embolism with retrievable IVC filters wasn’t worth it when compared to anticoagulants, which worked better and had fewer risks.
Contact the Boston IVC Filter lawyers at the Law Offices of Jeffrey S. Glassman, LLC, by calling toll-free at (617) 367-2900 for more information about how we can assist in your recovery of damages.