Loncar Lyon Jenkins is now filing IVC filter lawsuits in order to ensure victims of IVC filter defects receive compensation
Interior Vena Cava (IVC) filters are devices implanted in the veins of patients who suffer from the threat of pulmonary embolism, heart attack and/or stroke due to blood clots. IVC filters act to catch the blood clots as they travel through the blood stream. Certain IVC filters are permanent while others are designed to be retrievable. Because they are often used in trauma care, surgery and during child birth many patients do not know if they have a filter until there is a problem. Since their introduction in 2000, IVC filters have been plagued with problems and the FDA has received in excess of one thousand reports of adverse events due to the devices.
If you or someone you love were among those needlessly injured as a result of an IVC filter, you may be eligible for compensation. Even if your filter is functioning properly your rights may be impacted by recent court decisions and medical studies. Loncar Lyon Jenkins is investigating cases in all 50 states. Contact Loncar Lyon Jenkins immediately for a free, confidential case evaluation using the form on the side or by calling toll free at 800.285.4878. IVC filter lawsuits are being evaluated on a contingency fee basis, meaning you pay nothing unless a recovery is obtained.
Update: July 2015
FDA Issues Warning Letter to C.R. Bard
On July 13, 2015 the FDA issued a warning letter to C.R. Bard for misfiling customer complaints (including the report of a patient death), manufacturing the Recovery Cone Removal System without the required clearance or approval, and failing to inform the agency of serious device malfunctions.
The FDA stated that model RC-15 of the Recovery Cone was not included in the clearance of their IVC filters. In addition the warning letter stated that the model FBRC violates the Federal Food, Drug, and Cosmetic Act because they “introduced or delivered into interstate commerce for commercial distribution a device with major changes/modifications to the intended use without submitting a new premarket notification to the agency as required by section 510(k)”.
The letter also raises concerns about Bard’s adherence to Quality System Regulations at its Tempe facility. For instance a complaint related to the G2 IVC filter, about embolization of a detached filter arm, “was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death”. The FDA stated other complaints were also misfiled and some did not contain enough information.
The Tempe facility was also cited for violating Medical Device Reporting requirements, which means the plant failed to inform the FDA within 30 days of receiving complaints or information suggesting that one of its devices had malfunctioned and was likely to lead to death or serious injury.
Update: April 2015
Study Disputes Effectiveness of IVC Filters
On April 28, 2015 a study published in the Journal of the American Medical Association (JAMA) found that IVC filters were not as effective as blood thinners at preventing pulmonary embolism. An excerpt from the studies’ conclusion reads:
Among hospitalized patients with severe acute pulmonary embolism, the use of a retrievable inferior vena cava filter plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at 3 months. These findings do not support the use of this type of filter in patients who can be treated with anticoagulation.
Based off of this study, there is no reason for patients who can be treated with blood thinners to have used removable IVC filters.
Update: May 2014
FDA Safety Communication
On May 6, 2014 the FDA provided an update to their August 2010 safety communication. In their statement the FDA announced concern that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides. The FDA recommended that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed. Based upon their own quantitative analysis and mathematical model, 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.
Timely removal of the filter becomes problematic when a patient is not aware that an IVC filter was ever implanted. Other patients are not notified as to whether or not the filter they had implanted is a permanent or retrievable filter.
Update: August 2010
Initial FDA Safety Communication
In August 2010 the FDA released an initial safety communication stating that they had received 921 device adverse reports. In the reports, 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. These severely painful events can cause lower limb deep vein thrombosis (DVT), IVC perforation, heart and lungs perforation, and other life-threatening complications. As a result of this study the FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.
IVC Filters & Manufacturers
There are many companies that manufacture permanent and retrievable IVC filters. Loncar Lyon Jenkins is currently litigating cases involving retrievable IVC filters manufactured by C. R. Bard, Inc. and Cook Medical, Inc. including:
- The Bard Recovery
- The Bard G2
- The Bard G2 Express
- Cook Gunther Tulip
- Cook Celect
Other retrievable IVC filters and manufacturers under review by Loncar Lyon Jenkins include:
- B Braun Tempofilter
- Cordis OptEase
- ALN
- Rex Medical Options
- Rafael Medical
Boston Scientific’s Greenfield™ filter is a permanent filter and not one that Loncar Lyon Jenkins is currently litigating. However, physicians often use the term “greenfield filter” generically to refer to any IVC filter; both the permanent and retrievable filters. If your physician has told you or you recall hearing a physician refer to your filter as a “greenfield filter” that does not necessarily mean that you have a Boston Scientific Greenfield™ filter. There is no risk in allowing Loncar Lyon Jenkins obtain the hospital records to determine the manufacturer and model of your filter. If your filter is not one we are handling, we will mail you a copy of your records, close your file and we are owed nothing for our review of your case.
Mounting Evidence of IVC Filter Defects
The Bard Recovery IVC Filter and the Bard G2 IVC Filter system were both approved for sale under the FDA’s 510(k) protocol. The 510(k) approval allowed for clearance of the device without human clinical trials. The Bard Recovery IVC filter was first introduced in 2003 and only two years later was pulled from the market on the heels of damaging studies. It was then superseded by the Bard G2 IVC filter system. Unfortunately studies on the new G2 filter have also showed a proneness to fracturing and migration. One such study was published by the Journal of the American Medical Association in 2013. The study analyzed 978 patients from August 2003 to February 2011. Highlights from the study include:
- 679 retrievable IVC filters that were placed, 58 (8.5%) were successfully removed.
- Unsuccessful retrieval attempts were made in 13 patients (18.3% of attempts).
- Many IVC filters placed after trauma were inserted when the highest bleeding risk had subsided, and anticoagulant therapy may have been appropriate
- While many of these filters were placed because of a perceived contraindication to anticoagulants, 237 patients (24.9%) were discharged on a regimen of anticoagulant therapy.
The study concluded that the use of IVC filters for prophylaxis and treatment of venous thrombotic events, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in sub optimal outcomes due to high rates of venous thromboembolism.
Symptoms of IVC Filter Failure
- Severe pain in the lungs, heart, or other major areas
- Respiratory compromise (respiratory insufficiency, arrest and failure)
- Pulmonary embolus (blockage of an artery in the lungs)
- Hemorrhaging
- Perforation of vessels, tissue, and organs
- Death
IVC Filter lawsuits seek to compensate victims for expensive medical bills, lost income from time off work, and emotional distress from these complications. Lawsuits filed claim that the manufacturers knew or should have know abut the risk of severe damage before marketing their product. The manufacturers failed to properly warn patients about the risk of implanting an IVC filter, unnecessarily injuring thousands of Americans.
Do not trust your case to an inexperienced form or referral service. Loncar Lyon Jenkins is a law firm that has been at the forefront of pharmaceutical and medical device litigation nationwide since 1999, successfully resolving thousands of cases in that time. We have been investigating cases involving IVC filter injuries as early as 2011. Even if your filter is functioning properly you should contact Loncar Lyon Jenkins immediately to discuss your rights.
If you or someone you love were among those needlessly injured as a result of an IVC filter, you may be eligible for compensation. If you have suffered from filter migration, filter fracture, or organ perforation the law limits your time to act so contact Loncar Lyon Jenkins immediately for a free, confidential case evaluation using the form on the side or by calling toll free at 800.285.4878.
For more information on the IVC filter issue, click here to watch NBC’s reporting on the problem.
