Medical devices are designed with patient safety as a key priority. When doctors implant a device into a patient’s body, it is in an effort to do good, not harm. But despite approval from the Food and Drug Administration (FDA), some medical devices are found to do more harm than good after they are brought to the market and used in thousands, if not millions, of patients.
IVC filters are one example of a medical device that may do more harm than good in certain patients. Retrievable IVC filters are designed to provide protection from blood clots for a short amount of time. Surgeons are supposed to remove the filters once that time has elapsed. But studies and warnings from the FDA show that surgeons are not always removing the retrievable IVC filters from patients after their risk for blood clots has subsided, and these filters were not designed to remain in the body for long. Essentially, these tiny filters, which are meant to save lives, can actually put them at risk.
Retrievable IVC filters that are not retrieved can cause serious, life-threatening risks and complications. Essentially, IVC filters can become ticking time bombs — and it’s only a matter of time before complications from an unretrieved filter could arise.
Inferior vena cava filters, or IVC filters, are small, cage-like devices made of metal and are used in patients who are at risk for blood clots, especially those who cannot use traditional blood thinners.
IVC filters are used to catch blood clots before they reach the heart or lungs. These blood clots, called deep vein thrombosis (DVT), typically form in the inferior vena cava, the large vein that carries blood from the lower portion of the body back to the heart. These clots are dangerous and can cause heart attacks, strokes, and a condition called pulmonary embolism (PE) if they break off and travel to the heart or lungs.
IVC filters are intended to reduce the risk of these clot-related injuries, however, their use has come under scrutiny in the past several years because they may cause more harm than good in many patients.
This is especially true for retrievable IVC filters, the newest types of filters to hit the market. Retrievable IVC filters are designed to reduce a person’s risk for blood clots for a short amount of time, typically for less than a year. Once the person’s risk for blood clots has subsided, the IVC filter should be removed by a surgeon. This is not the case for the majority of IVC filter patients.
Retrievable IVC filters that are left in place for too long can cause serious problems of their own. The device may break apart in the patient’s body and travel to the heart or lungs causing heart attack or pulmonary embolism — the same medical emergencies the filter is intended to prevent. The devices may also puncture the lining of the inferior vena cava or break through the vein entirely and travel to other parts of the body.
There are other risks associated with leaving a retrievable filter in place for too long, and many patients do not realize they have one of these filters in place. In some cases, patients don’t experience symptoms from a fractured or migrated device until it’s too late.
IVC filters have been around for decades, but the original devices were designed to be permanent implants. Newer filters that came on the market in the early 2000s, on the other hand, were designed to be removed after a short period of time. Once a person’s risk for blood clots subsided, these retrievable IVC filters are supposed to be just that, retrieved.
Since the FDA approved retrievable filters less than 20 years ago, their use has grown dramatically. Doctors implanted about 167,000 filters in 2007 and it was estimated that nearly 260,000 filters would be used in 2012. Compare those numbers to just 2,000 filters implanted in 1979, when traditional filters were the only design on the market.
Doctors use IVC filters, both retrievable and traditional filters, in patients who are at-risk for blood clots. Doctors may choose to use an IVC filter in:
Patients who may be at a short-term risk for blood clots, such as those who suffered severe trauma or are undergoing surgery, may have a retrievable filter implanted to temporarily reduce their risk. Retrievable filters should be removed after a patient’s risk subsides, and were not designed to stay in the body for a long time.
Most retrievable IVC filters should be removed within a few months of implantation, but many patients live their lives for years with a retrievable filter still implanted. The longer a retrievable filter remains in place, the harder it is to remove and the riskier it is for patients.
The use of retrievable IVC filters has come under scrutiny in recent years due to the number of complications these filters can cause. Studies have shown that the use of IVC filters in trauma patients, for instance, can do more harm than good.
A JAMA Surgery study published in January 2017 showed IVC filters did not provide any additional lifesaving benefits to trauma patients and may actually be more risky for those patients because removal rates were so low. The single-center study looked at the mortality rates of trauma patients at risk for blood clots and found using IVC filters did not decrease their risk for death or other complications.
Another study, published in JAMA Surgery in August 2017, called the use of IVC filters in trauma patients “controversial” and a study published one month later said there is “growing concern for overuse of IVC filters, with a relatively low rate of retrieval.”
IVC filters are designed to save people from life-threatening injuries, but the filters can cause a number of serious complications on their own, as evidenced by numerous studies.
Side effects and complications associated with IVC filters include:
Long-term risks of IVC filters include deep vein thrombosis and blockage of the IVC, called occlusion.
As the potential risks of IVC filters became apparent, the FDA got involved, issuing safety communications to the public and conducting analyses of the adverse event reports it received from doctors and patients across the country.
The FDA first took action in August 2010 when it issued a safety communication to physicians and the public. The FDA said it had received a number of adverse event reports regarding the filters and worried retrievable filters were being left in the body too long.
From 2005 to 2010, the FDA received 921 adverse event reports relating to different IVC filter brands. The reports indicated the filters could cause serious complications in patients including:
Some of these complications led to other serious injuries in patients.
The FDA advised physicians to remove retrievable filters as soon as a person’s risk for pulmonary embolism had subsided because the longer a filter remained in place, the harder it would be to remove it.
In May 2014, the FDA issued an updated safety warning, advising doctors of the ideal window for safe filter retrieval. Based on its own analysis, the FDA said filters should be removed between 29 and 54 days after the device had been implanted, as long a patient’s risk for PE had subsided.
The FDA didn’t stop at issuing safety communications about the risks of IVC filters. The federal agency required manufacturers of retrievable IVC filters on the market at the time to participate in clinical trials to further assess the safety of the filters.
In its May 2014 communication, the FDA wrote:
Although the results of the decision analysis provide important insight for retrievable IVC filters, the FDA is requiring collection of additional clinical data for currently marketed IVC filters in the United States. The studies will address safety questions that remain unanswered for both permanent and retrievable filters. … The data gathered from the [studies] will help the FDA, manufacturers and healthcare professionals assess the use and safety profile of these devices, understand evolving patterns of clinical use of IVC filters and ultimately improve patients care.
Some of these studies are still ongoing, however, a number of manufacturers removed their retrievable filters from the market, presumably due to the safety concerns they presented. CR. Bard Inc., for example, stopped selling a number of its IVC filters in the U.S., though it did not issue a formal recall of the devices. Those devices are now the focus of hundreds of lawsuits filed by patients harmed by the problem filters.
Hundreds of thousands of people have been implanted with retrievable IVC filters over the last decade and a half, leaving them wondering, “What do I do now?”
The FDA told doctors to remove retrievable IVC filters as soon as a patient’s risk for clots subsided. The agency also recommended patients go to follow-up visits with their doctor to decide whether the filter can and should be removed. Oftentimes, a retrievable filter is left in place too long and removal becomes too difficult. This is why removing the filter as soon as blood clot risk subsides is so important.
The longer a filter is left in place, the more likely it is to cause problems. Many patients who do not show signs or symptoms of complications find out their filter has moved or fragmented when they go in for a follow-up visit with their doctor.
These follow-up visits usually include CT scans, which show where the filter is in the body and whether or not it has tilted, moved, or fractured. These tests are expensive; many patients find the medical costs too burdensome and they will put off the tests or won’t get them at all. There are programs available, however, that can help pay the costs of these medical tests.
Patients with retrievable IVC filters should get them removed once their risk for blood clots or related complications subsides. This can be an expensive process, with medical tests like CT scans ranging in the thousands of dollars depending on insurance. There are programs available for IVC filter patients who cannot afford to get these medical tests done otherwise.
Schmidt National Law Group can help set patients up with a health concierge who will work directly with patients and help them get the health screenings they need. These health concierges will work with patients to arrange a telephone interview with an Interventional Radiologist (IR) to ensure patients are a good candidate for a CT Scan with Contrast. This is the test that shows doctors where the IVC filter is located in the body. The contrast dye helps doctors see the filter better.
Once a patient is approved, a referral is made and an appointment is scheduled at a center near the patient’s home or office. If a patient has transportation issues, Schmidt National Law Group has a national Uber/Lyft account and can also pay for a cab service to make the patient’s travel as easy as possible.
As soon as the images are obtained from the CT scan, they are sent over to a group of IR’s who re-read the images and generate reports in detail.
This program can be extremely valuable to patients. Consistent with the growing body of evidence and studies, Schmidt National Law Group is finding that over 90 percent of clients have a significant injury. Keep in mind that with the concierge service, Schmidt National is currently only prosecuting Cook, Bard, and Cordis cases.
In light of safety concerns over retrievable IVC filters, patients harmed by the devices have begun filing lawsuits against their manufacturers. There are a number of filter manufacturers, but the majority of cases are being brought against three major companies: C.R. Bard Inc., Cook Medical, and Cordis Corporation.
Some of the problematic brands of IVC filters involved in the lawsuits include:
The lawyers and attorneys at Schmidt National Law Group are working with patients injured by these devices to bring cases against their manufacturers. These lawsuits accuse device makers of a number of legal claims, including:
If you developed complications after being implanted with a retrievable IVC filter you may be entitled to financial compensation. There may be significant settlements or cash payouts for those affected by the devices. Call Schmidt National Law Group today to see if you qualify for an IVC filter lawsuit. Once you qualify, you may be able to participate in Schmidt National’s concierge program to get the medical tests you need to see if your IVC filter could cause complications and for your own peace of mind.
Thousands of lawsuits have been filed against the major manufacturers of IVC filters. The large number of IVC filter lawsuits filed against C.R. Bard Inc. and Cook Medical led to the consolidation of these claims into multidistrict litigation in two U.S. district courts.
Multidistrict litigation, or MDLs, are formed when multiple lawsuits alleging similar claims against a corporation are filed in federal court. MDLs help the courts save time and money because they streamline the discovery processes and allow attorneys on both sides to exchange ideas and information about the cases.
A few cases are usually chosen out of the pool of lawsuits to be tried first in court. These bellwether trials allow attorneys to test out legal theories before a jury and can help steer future settlement talks. MDLs are different from class action lawsuits in that cases in an MDL are filed individually, whereas class action lawsuits are filed by one or more plaintiffs on behalf of many others affected in a similar way. Any settlements or verdicts awarded in an MDL are handed down individually and are not split equally among plaintiffs, like in a class action lawsuit.
IVC filter lawsuits against C.R. Bard Inc.’s Recovery, G2, and G2 Express filters were consolidated in the District of Arizona in 2015. U.S. District Judge David G. Campbell presides over the litigation, which included more than 3,000 lawsuits in November 2017.
Other IVC filters manufactured by Bard, including its Eclipse, Denali, and Meridian filters, are also involved in the lawsuits.
Bellwether trials in this MDL were scheduled to begin in Fall 2017.
Lawsuits involving Cook Medical’s Celect and Gunther Tulip filters were consolidated before U.S. District Judge Richard L. Young in the Southern District of Indiana in 2014.
Only 27 lawsuits had been filed in federal court against Cook when the MDL was established. In November 2017, more than 3,000 lawsuits were pending in the coordinated proceeding, and more are expected to be filed in the future.
The first bellwether trial in this MDL was scheduled to begin in October 2017, with the second bellwether following in April 2018.
Judicial Panel on Multidistrict Litigation. Transfer Order. “In Re: Cook Medical, Inc., Ivc Filters Marketing, Sales Practices And Products Liability Litigation. MDL No. 2570. Retrieved from: http://www.insd.uscourts.gov/sites/insd/files/MDL%202570%20Transfer%20Order.pdf
IN RE: Bard IVC Filters Products Liability Litigation (MDL 2641) in the U.S. District Court for Arizona. Retrieved from: http://www.azd.uscourts.gov/case-info/bard
In Re: Cook Medical, Inc., Ivc Filters Marketing, Sales Practices And Products Liability Litigation. “Second Amended Case Management Order # 19 (Third Amended Bellwether Trial Plan)” Filed August 23, 2017. Retrieved from: http://www.insd.uscourts.gov/sites/insd/files/SECOND%20AMND%20CMO%2019%208-23-2017.pdf
Medscape. “Inferior Vena Cava Filters.” Updated December 2015. Retrieved from:
University of Washington Medicine. “Inferior Vena Cava (IVC) Filter Replacement or Removal.” Retrieved from: http://www.uwmedicine.org/health-library/Pages/inferior-vena-cava-ivc-filter-replacement-or-removal.aspx
Medscape. “Safety and Effectiveness of Inferior Vena Cava Filters Used to Protect Against Pulmonary Embolus: A Technology Assessment.” Judith Walsh, MD, MPH. Published 2011. Retrieved from: http://www.medscape.com/viewarticle/744331_2
Vascular Disease Management. “IVC Filters: Indications and Evidence.” Neil J. Rane et al. Published Nov. 7, 2009. Retrieved from: http://www.vasculardiseasemanagement.com/content/ivc-filters-indications-and-evidence
American College of Cardiology. “Appropriate Use of Inferior Vena Cava Filters.” Published Oct. 31, 2016. Retrieved from: http://www.acc.org/latest-in-cardiology/articles/2016/10/31/09/28/appropriate-use-of-inferior-vena-cava-filters
FDA. “Removing Retrievable Inferior Vena Cava Filters: Initial Communication.” Published Aug. 9, 2010. Retrieved from: https://wayback.archive-it.org/7993/20161022180008/http:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm
FDA. “Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication.” Published May 6, 2014. Retrieved from: https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm396377.htm
Techniques in Vascular and Interventional Radiology. “The Role of Inferior Vena Cava Filters in Pulmonary Embolism.” Steinberger JD and Genshaft SJ. Published September 2017. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmed/29029715
JAMA. “Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial.” Mismetti P. et al. Published April 28, 2015. Retrieved from: http://jamanetwork.com/journals/jama/fullarticle/2279714
JAMA Surgery. “Association Between Inferior Vena Cava Filter Insertion in Trauma Patients and In-Hospital and Overall Mortality.” Shayna Sarosiek et al. Published Jan. 1, 2017. Retrieved from: http://jamanetwork.com/journals/jamasurgery/article-abstract/2556171