An IVC filter is a small metal device placed inside the inferior vena cava that is designed to filter or "catch" blood clots that travel from the lower portions of the body to the heart and lungs.
Blood clots in the legs or pelvis can occasionally travel to the lungs, where they could cause a pulmonary embolism (PE) or blockage. The IVC filters help reduce the risk of this by trapping the large clots, preventing them from reaching the heart or lungs. To place them, an interventional radiologist uses image guidance. The filter was first manufactured in 1979 and has been inserted into over 260,000 patients.
Lawsuits are being filed around the country amid reports that too many of these IVC filters cause more harm than good. These IVC filters are allegedly prone to fracture, tilt, migrate, perforate the IVC walls, and break apart.
Call Miller & Zois at 800-553-8082 or get a free, no obligation online case review if you believe you have been harmed by an IVC filter.Why an IVC Filter?
IVC filters are not the preferred or the first method of treatment. Doctors typically will not use IVC filters in patients who can take blood thinners such as Warfarin. The filters do, however, demonstrate a high rate of success in patients who do not respond well to conventional medical therapy such as anticoagulants.
The filters are used in patients who have a history of or are at high risk of developing blood clots in their legs. Patients this may include are:
- Patients diagnosed with deep vein thrombosis (DVT)
- Patients with pulmonary embolus
- Trauma victims
- Immobile victims
- Patients recovering from a recent surgery or delivery of baby
Until recently, the IVC filter was only available as a permanently implanted device. However, new filters that have the option to be removed later on or remain permanent have developed. These retrievable filters should be removed as soon as possible after the risk of a clot traveling to the lungs has passed. This helps eliminate the long-term risks of having a filter in place such as a fracture or recurrent DVT.
Many of the major concerns with the IVC devices is regarding the retrievable ones. They have been noted to cause damage to the veins and also are less effective at stopping blood clots. They are intended for short-term use, and the concern comes when they stay inside the patients for too long. The FDA recommends that they are removed between the 29th and the 54th day after they are implanted. Risks
The benefit of using an IVC filter is that there is no surgical incision, and they have a high rate of success in protecting the lungs from serious pulmonary embolisms. You cannot minimize how important this is for patients. But, and this is a big "but", there are many risks associated with their use that might not pass risk/benefit muster with some patients (if they understood all of the risks). Some common injuries may include:
- Chest pain
- Heart rhythm problems
- Neck pain
- Shortness of breath
- Hemorrhaging or internal bleeding
Published studies and reports from the FDA show that risks associated ith Bard's IVC filters include, but are not limited to, deep vein thrombosis, filter fracture, filter migration, filter embolization, and IVC perforation.
However, recently IVC filters have been linked to more severe, potentially deadly injuries. These include hemorrhage, pulmonary embolism, and stroke. The FDA & Studies
In 2010, the FDA issued a safety alert regarding the retrievable IVC filters. They looked at data from 921 reports of adverse events after using the filters from 2005 - 2010. There were four categories of concern:
- Device migration
- Filter perforation
- Filter fracture
- Detached device components (Device embolization)
Device migration accounted for the largest portion, 35%, and is when the filters move away from their intended location.
In 2013, the Journal of American Medical Association looked at the failure rate of the filter. They found that only 58 of the 679 retrievable IVC filters that were inserted were later removed. This is after the FDA suggested that retrievable filters be removed between 29 and 54 days after implantation. Further, JAMA found that when the filters stayed in patients longer than necessary, 18.3% attempts at removing them failed, 7.8% had venous thrombotic events, and 25 patients suffered pulmonary embolisms.
Another study was done that found the five retrievable IVC filters most prone to failure - Bard's Recovery, Bard's G2, Bard's G2 Express, Cook's Gunther Tulip, and Cook's Celect.
Bard's Recovery was a first-generation product that was brought onto the market in 2003. 25% of these filters failed, causing the filter to fracture or break. In 2005, Bard's G2 came out as a replacement for the Recovery filter. This new one had a 12% failure rate but was on the market for a shorter amount of time than the Recovery. In 2008, Bard's G2 Express was released. The study found that combining all of Bard's device, they had about a 12% fracture rate.
The two Cook's devices, Gunther Tulip and Celect, had a history of perforating the patient's vena cava wall within 71 days of implantation of the device. Further, they were found to migrate out of their place in 40% of the patients.
A study in 2013 from the Archives of Internal Medicine found that only half of all IVC implantation surgeries were necessary. The study also found that IVC filter patients had a much higher in-hospital mortality rate, almost double.
The Boston Medical Center looked at data from 2003-2011 and found that many of the IVC filters placed after a trauma were inserted after the highest risk of bleeding had passed, and therefore other treatment such as anticoagulant therapy, was appropriate. The FDA reiterated its safety concern in 2014 about the devices.Lawsuits
Patients suffering complications after the use of Bard and Cook's IVC filters began filing lawsuits against the manufacturers, alleging migration and breakage causing organ damage along with other complications. C.R. Bard and Cook Medical have been the target of IVC filter litigation, with claims against them including:
- The IVC filter carries an unreasonable risk of fracture of the device
- The IVC filter has an unreasonable risk of migration in the body and the manufacturer failed to warn doctors and patients of this problem
- The IVC filter has an unreasonable risk of perforation of the patient's organs and the manufacturer failed to warn doctors and patients of this problem
- The exterior surface was inadequately prepared which causes the filter to be at great risk of weakening and failure
- The IVC filter cannot tolerate the global stressors of the respiratory and cardiac cycles of the human body
- The IVC filter had insufficient strength or structural integrity to withstand normal placement within the human body
The first cases were against Bard in California and Pennsylvania in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) consolidated cases in 11 districts into MDL in Indiana. This is done to centralize and streamline the litigation process (get a full explanation of the MDL process). In August 2015, the Panel on MDL consolidated suits against Bard in Arizona. Fifty of these are still pending. There are a number of suits pending against Cook and Bard in both federal and state courts.
One woman filed a suit against Bard after her G2 filter, which was implanted in 2006, fractured and migrated to her heart two years later. This caused ongoing heart issues, and as she declined to have heart surgery to remove the fragment, she will be on blood thinners the rest of her life. She claims that Bard failed to warn physicians of G2's risks and misrepresented the device as being safe.
Another man filed a claim against Bard in 2011, as the case above, where a G2 filter fractured after being in place for two years. The pieces went to various parts of her body, damaging her heart and lungs. She claims she has suffered loss of a normal life, pain, suffering, disability, disfigurement, impairment, emotional trauma, and loss of consortium. She alleges that Bard was negligent in the design, and misrepresented the filter as being safe and effective.
In 2010, a man had a Cook IVC filter put in place after having knee surgery. In 2014, the device fractured and migrated to his heart, causing him to lose consciousness while driving and requiring three surgeries. His claim against Cook alleges recklessly designing, testing, and manufacturing the Celect filter.
In the first case to go to trial, an Arizona jury found no negligence or selling of a defective product. The plaintiff claimed her IVC Recovery filter fractured and traveled to vital organs. However, Bard was able to convince the jury that the filter was reasonably tested and that the fracture rate was no more than the accepted industry average.
In Florida, Bard won partial summary judgment in a case due to undisputed evidence that perforation is a risk inherent in the design of all IVC filters. The judge instructed the plaintiff that she could not sue the company over failure to warn or negligence misrepresentation, but that the plaintiff was still entitled to sue for alleged design flaws and punitive damages from the injury she sustained when her G2 filter perforated her inferior vena cava.
Bard has also settled several cases. In Nevada, a man had the Bard's Recovery IVC filter implanted in 2005. It migrated to his heart, forcing him to undergo emergency open heart surgery in 2010. Ten days into the start of his trial, Bard settled. In January 2015, Bard agreed to a confidential settlement eleven days after the start of the trial. This came about as a plaintiff produced evidence that Bard had known since 2004 that the Recovery filter was not reasonably safe.
This evidence was key and is controversial. Less than one year after the release of the Recovery filter, Bard received complaints of it malfunctioning due to the legs breaking off. Bard hired an independent consultant to prepare a report, comparing the fractures and migration rates of their new filter to previous 2004 models, without telling the public or the FDA. In December 2004, the consultant completed his report, finding that the Recovery filter experienced complication rates higher than competitors and that further investigation was necessary. Bard's lawyers distributed copies on a strict need-to-know basis and required the people in receipt of the reports to keep it a secret. Once lawsuits began being filed, the reports became public. Bard has argued for confidentiality of the reports under the work-product doctrine, and the courts currently differ on the status of this argument. A California State Court denied Bard's request to have the documents returned or destroyed, while a U.S. District Court of Nevada ruled that the reports could not be used in the case.Why Have IVC Lawsuits Been Unsuccessful
No IVC filter suits so far have made it all the way through trial with a successful jury verdict. Yet many plaintiffs' attorneys are still very high on these case. Why?
If the IVC filter cases lead to large settlements and judgments, it will follow the course of many mass tort cases in the United States. First, patients experience significant problems. Lawyers take notice and lawsuits are filed. But the science has not yet caught up with what appear to be pretty obvious facts on the ground. So the victims lose. But then the science catches up and the plaintiffs' lawyer get smarter (and start working together). IVC Lawsuits Status Update
Bellwether trials in Indiana set to begin in 2017 may begin to turn the tide for victims. These trials will be test runs and will set the bar for all the other hundreds of plaintiffs who claim that the devices are prone to breaking and causing major injuries.
One of these trials involves a woman from Florida. The doctors were unable to remove her IVC filter, and after three years, she was experiencing "persistent, severe gastrointestinal symptoms, fatigue, diarrhea, vomiting, and abdominal pain." The doctors found that the filter had punctured her vein, and was embedded in her intestine. She suffers narrowing at the explant site of the filter and claims that Cook concealed the known risks and failed to warn of known or scientifically knowable dangers.
There are three class-action type lawsuits filed currently, from those who received Bard's IVC filters in Florida, Pennsylvania, and California. They argue that plaintiffs with either the Bard Recovery, Bard G2, and Bard G2 Express filters that have not had a fracture or migration of the device must receive medical monitoring due to Bard's negligence, misrepresentation, and concealment of data. They claim that each person with a device in them makes up a class, and that the class should be compensated for medical monitoring expenses. The courts have not yet approved the formation of the class.
As of August 2016, 1,500 IVC blood clot filter suits are filed, with plaintiffs alleging similar blood clot filter side effects to the described claims. Most of these are centered around the retrievable models.Getting a Lawyer to Help You Fight Back
If you or a loved one has suffered serious side effects and deaths caused by IVC filters, call us today at 800-553-8082 or get a free, no obligation online case review.