Over 400 injured patients, some of whom will live permanently with broken medical devices inside their own bodies, have chosen to pursue legal action, suing the manufacturers of IVC filters – small implants that act as a net for blood clots inside one of the body’s largest veins.
Lawsuits Accuse Companies Of Promoting “Defective,” “Dangerous” Device
Instead of forestalling the incredible risks of pulmonary embolism, IVC filters are prone to failure. The devices can break apart inside the vein, releasing dangerous shards of metal to threaten vital organs. Even filters that don’t fracture in this way are liable to pierce the vein in which they are implanted, increasing the risk of internal bleeding. IVC filters can even “migrate,” moving out of position along with blood flow and entering chambers of the heart.
Some models have been found to “fail,” either breaking apart or migrating entirely from the site of implantation, in up to 32% of patients.
The general public was alerted to these dangers in 2010, when the US Food & Drug Administration announced that it had received more than 900 reports of serious filter failure in the span of only five years. Patients, on the other hand, have been aware of these risks for much longer – many through tragic personal experiences. IVC filters have been linked to numerous deaths; at least 27 fatal events were associated to just one model, C.R. Bard’s Recovery IVC filter, by an NBC News investigation. Survivors have now begun to file wrongful death lawsuits, seeking compensation for the loss of their loved ones.
Broken Filters, Pierced Organs Spur Legal Action
Robert Boddorf, a 49-year-old from Hilliard, Ohio, says an IVC filter, a Günther Tulip manufactured by Cook Medical, punctured his blood vein. The device, equipped with 12 “struts” to grip the inferior vena cava and trap blood clots, was implanted in November of 2011. But Boddorf only suspected there was a problem one year later, on December 18, 2012, when he presented to a hospital run by Ohio State University with strange pain in his groin.
After a CT scan, Boddorf was told that three of the filter’s struts had perforated his vein. One of the components ultimately pierced his duodenum, a cavity of the small intestine. Now more than three years after he learned of the filter’s failure, two struts remain “embedded” in Boddorf’s psoas muscle and a bone of his vertebrae. His doctors, fearful of causing more damage, have proved unwilling to remove the device.
Boddorf filed a lawsuit (PDF) against Cook Medical on December 1, 2014, accusing the company of promoting a “defective” implant as “safe and effective,” despite meager clinical trial results “[in]adequate to support [either] long or short term efficacy.”
Lawsuits Against Cook & C.R. Bard Consolidated
His story is not unfamiliar. More than 230 other patients have chosen legal action against Cook, a response so overwhelming that their lawsuits have been consolidated in the US District Court for the Southern District of Indiana. Together, these plaintiffs, who make similar allegations as Boddorf, will progress through pre-trial proceedings simultaneously.
C.R. Bard, a company that has found itself under considerable scrutiny from the media, is in a similar position. Over 210 lawsuits have been filed against Bard, manufacturer of the wildly-popular Recovery (before its withdrawal from the market in 2005) and G2 series IVC filters.
Emily Landress, a woman from Georgia, underwent a placement procedure on February 20, 2012, receiving one of Bard’s G2 filters. Like Boddorf, Landress claims she learned of the IVC filter’s risks more than one year after her procedure. Suffering from severe chest pain, a commonly reported omen of filter failure, she rushed to the hospital. Radiologists were able to locate her filter on an X-ray – but the device was missing one of its struts. The device had “fractured,” and further tests discovered the broken component in the right ventricle of Landress’ heart.
Emergency surgery was scheduled for the very same day, August 1, 2013. Surgeons successfully removed the broken IVC filter, but decided that the strut lodged in their patient’s heart “could not be safely extracted.” It’s still there, three years later, and Landress says she may live forever at an increased risk for cardiovascular complications.
Did Bard’s “Silent Recall” Hide Filter’s Failings?
C.R. Bard, Landress and more than 200 other plaintiffs claim, was well aware of its device’s risks. The G2 filter was designed to replace an earlier implant, the company’s Recovery Filter, which had been associated to numerous adverse events, including a growing number of reports involving filter fracture.
Bard recognized that its Recovery device was flawed in both manufacturing and design, patients say, and in 2004, began redesigning the implant secretly. Soon enough, the G2 filter was born and Bard quietly introduced it onto the market. The “new” G2 implant, substantially similar to its predecessor, was a hit, and its popularity overshadowed the problems that had been identified with the Recovery model. As for the previous device, Bard “quietly stopped selling” it, Landress writes in her complaint (PDF).
But the company chose not to issue a recall, despite the fact that thousands of patients were now harboring potentially life-threatening medical devices inside their bodies. Landress claims the company “failed to make any effort” to warn patients or physicians of the Recovery filter’s significant dangers. The G2 Filter, which was removed from Landress under emergency circumstances, proved no safer than its predecessor, she claims.
Landress is still waiting for justice. Her lawsuit has been consolidated along with 200 others in the US District Court of Arizona, under the guidance of federal Judge David G. Campbell.
A Virtually “Untested” Device, Patients Say
Facing the significant risks of pulmonary embolism, thousands of American patients have been implanted with IVC filters. It’s an old concept, used primarily in patients who don’t react well to anticoagulants, the industry standard treatment for people at risk of developing blood clots. But it’s also an almost completely untested concept.
To date, only one major study has even looked into the relative benefits of IVC filters over blood thinners. That paper, titled PREPIC, tracked 200 patients with IVC filters, and another 200 who used only anticoagulants, over a course of 8 years. In the end, the filters appeared to prevent more blood clots from reaching the lungs, but ultimately failed to prevent any more deaths than blood thinners were able to prevent. The researchers found that any benefits presented by IVC filters were canceled out by an increased risk for deep vein thrombosis (a blood clot that develops in the “deep veins” of the legs).
Most manufacturers have been loath to admit that their implants, which seem like they should work, have never been proven effective by medical researchers.
What’s Wrong With IVC Filters?
Many of the device’s problems, including its apparent tendency to break, have been associated with the length of implantation. IVC filters, at least the new generation of these devices epitomized by Cook Medical’s Günther Tulip and Bard’s G2 models, are designed to be “retrievable.” Implant them fairly painlessly with a catheter, and then remove them once a patient’s risk of pulmonary embolism has subsided.
That was the idea at least – but when the retrievable filters hit the market, manufacturers provided no guidelines on when to take them out. It’s not uncommon to read about patients who have had IVC filters for five, six or even seven years at a time, far longer than the 29 to 54 days now advised by the FDA. Plaintiffs claim the companies behind these implants were perfectly aware of the dangers associated with longer “indwelling” periods, but concealed that information from the public.
Alleged Design & Manufacturing Defects
Patients have also pointed to a number of design and manufacturing “features” (which they dub “defects”) that could explain the extraordinarily high failure rates.
Most IVC filters are made of either conichrome or Nitinol. Conichrome is an alloy of cobalt, chromium, nickel, iron and molybdenum, used most notably to construct Cook Medical’s devices. Nitinol, used mainly by C.R. Bard, is an alloy of nickel and titanium that was created by the US Navy for ordinance. Both of these materials, plaintiffs claim, are insufficient to withstand even the normal ebb and flow of human circulatory and respiratory systems.
Conichrome, despite the fact that Cook advertised its use of the material as a way to “reduce[…] the risk of fracture,” is unable to withstand the standard pressures of being inside the human body, plaintiffs say. Nitinol, on the other hand, was designed in part to bend under heat and pressure, then spring back to its former shape. But during Bard’s manufacturing process, patients have discovered, the struts of its devices are machined with miniscule grooves. Rather than responding elastically to circulation, the implant’s develop tiny stress fractures – and eventually break.
Plaintiffs point to an even more recent device, Bard’s Eclipse filter, which is taken through an additional manufacturing step, known as “electro-polishing,” to suggest the company has long known the grooves present a significant problem.
Manufacturers Face Allegations Of Fraud, Illegal Promotion
At least 7 companies currently manufacture IVC filters that are sold in the US. We’ve already discussed the world’s largest filter manufacturers, Cook Medical and C.R. Bard, because most of the lawsuits involving filters have been filed against those companies. Many smaller companies make their own versions of the device, including:
- Rex Medical, a Pennsylvania-based company, designed two Nitinol IVC filters, the Option and OptionELITE models. The devices are now manufactured and marketed by Argon Medical Devices, a company in Texas.
- ALN, a French manufacturer, produces and markets the ALN Optional Vena Cava Filter. It’s the only medical device ALN makes.
- B. Braun, another Pennsylvania corporation, manufactures two IVC filters: the Vena Tech LP and the TempoFilter.
- California’s Volcano Corporation makes the Crux Vena Cava Filter, which is very different from the other filters we’ve discussed. The Crux makes use of a spiral design, rather than spider-like struts, to hold itself in place inside the vein.
Despite differences in design and manufacturing, none of these devices have been excluded from scrutiny. The FDA’s multiple warnings on the subject pertain to retrievable IVC filters in general, not specific manufacturers or models.
Is This A Class Action?
No. Our team of experienced attorneys intends to file only individual personal injury lawsuits. While several class actions have been filed, against both C.R. Bard and Cook Medical, we believe individual lawsuits are a more appropriate choice under the circumstances.
Recall that hundreds of lawsuits have already been filed, and most are now “consolidated” in two federal courts. This legal mechanism, which takes individual lawsuits filed across the country and then transfers them to a central court, is known as “Multi-District Litigation,” or MDL. MDL recognizes that multiple lawsuits make very similar allegations against one defendant, but unlike a class action, consolidation allows individual plaintiffs to retain complete control over their own lawsuits.
We think that’s the best way to handle these claims, since every plaintiff’s situation will be different, and their needs will be, too.
Breaking IVC Filter Lawsuit News
By Joseph Osborne
February 28- 2017- New York Man Files IVC Filter Lawsuit
A New York man who was implanted with a C.R. Bard 52 Vena Cava Filter on April 16, 2008, has filed a lawsuit. The man filed his lawsuit on February 23, 2017, in the U.S. District Court for the District of Arizona. The plaintiff alleges that he was injured by a vascular blood clot filter that is known to break in 38 percent of patients within 5 years. This particular lawsuit was centralized with nearly 1,470 other IVC filter lawsuits that are now pending against C.R. Bard in Multi-District Litigation.
January 27, 2017- Study Questions The Use Of IVC Filters In Patients
A study published in the scientific journal JAMA Surgical reveals that IVC filters may not help people who are at risk of dangerous blood clots to improve their chances of survival. Researchers looked at medical data from patients who have IVC filters implanted at Boston Medical Center between August 1, 2003, and December 31, 2012. Of the 451 patients with an IVC filter and the 1,343 matched controls without a filter, the average age was 47.4 years. The results showed that over a period of nearly four years, there was no significant difference in overall mortality or cause of mortality in patients with an IVC filter compared to those without.
December 21, 2016- Pennsylvania Woman Files IVC Filter Lawsuit After Option Elite Filter Was Removed
A Pennsylvania woman has filed an IVC filter lawsuit after multiple procedures were performed on her to remove the filter trapped in her body. She was implanted with the Option ELITE Retrievable Vena Cava in 2015 at Wellspan York Hospital in PA. She had to go back to the hospital 10 months later to have the filter removed, where her doctor discovered that the filter was tilted and the retrieval hook was embedded in the wall of her blood vessel. For more details about this lawsuit go here.
November 25, 2016- Woman From Alabama Files Bard Eclipse IVC Filter Lawsuit
An Alabama woman states that she was injured by a blood clot filter and has subsequently filed a lawsuit alleging that C.R. Bard sold a defective medical device and failed to warn about possible health risks. The Alabama woman was implanted with the C.R. Bard Eclipse Vena Cava Filter on January 13, 2011. Eclipse is a newer member of a long line of IVC filters that were linked to safety risks and pulled off the market without a recall. The filters were replaced by “new” filters that had nearly identical designs and defects.
October 27, 2016- Timing Of Bellwether Trials Ruled By Judge In Cook IVC Filter Litigation
On October 18, 2016, District Judge Richard Young issued a ruling for the first three Cook IVC bellwether trials. The first two bellwether cases have been ordered by the court to be ready for trial by October 2, 2017, and the third one to be ready by April 2, 2018. The Court noted in a recent ruling that the purpose of choosing bellwether cases for trials is in order to enhance the settlement prospects of the multitude of pending cases involving the Celect and Günther Filters.
September 15, 2016- IVC Filter Lawsuits Prove Devices Require Immediate Removal
The hundreds of lawsuits filed in connection with the IVC filters have shown that one of the serious problems with the filters is their design. The devices were designed to be used as a temporary measure, however, they are left in a patient’s body longer than they should be. What is more concerning is the fact that the longer they are left in a patient’s body, the harder it is to remove them. This also increases the likelihood of the device fracturing or migrating to other parts of the body and causing serious injury. Right now it is still being questioned why the IVC filters are left in a patient’s body for months and even years if they were only meant to be in for a brief period of time. There is also the problem that even within the brief period of six-weeks, IVC filters have been noted to have already migrated and lodged in tissue.
August 31, 2016- California Woman Files Lawsuit For Failed Cook Celect IVC Filter
A California woman recently filed a product liability lawsuit, stating that she experienced serious health problems after a Cook Celect IVC filter failed. The IVC broke into small pieces and lodged in her heart. The complaint was filed in the U.S. District Court for the Central District of California stating that the blood clot filter was defective and unreasonably dangerous. Due to the IVC filter complication, the complainant had to undergo extensive medical care and is now facing on-going problems.
June 28, 2016- New Jersey Woman Files Lawsuit For Injuries Caused By IVC Filter
On June 20, 2016, a woman from New Jersey filed a lawsuit in the U.S. District Court for Arizona for injuries she allegedly suffered because of the Meridian Vana Cava Filter made by C.R. Bard and Bard Peripheral Vascular, Inc. The woman is accusing the makers of the filter of negligence for creating and selling a defective medical device and then for failing to give warning about the side effects as well as breaching implied and express warranty.
May 26, 2016- IVC Filter Lawsuit Has Been Filed In PA
A man from Pennsylvania has filed a lawsuit after his IVC filter broke and ended up embedded in his heart. The man had the device implanted at Wellspan Health Hospital in York, Pennsylvania in June 2012. He ended up having surgery to remove the filter in December 2015 and his doctors discovered that the filter was tilted. An arm of the filter had broken and traveled into his heart. He has filed his lawsuit on the basis that Cook Medical concealed the risks of the filter and falsely promoted it as safe.
April 29, 2016- Bellwether Trials To Be Prepared For More IVC Blood Clot Filter Litigation
As the numbers increase of lawsuits filed in connection with IVC blood clot filters in courts all over America, U.S. groups of cases against Cook Medical and C.R. Bard are due to be chosen as “bellwether” claims. The bellwether claims will be prepared for early trial dates that will help gauge how juries might respond to some evidence and testimony that might be repeated in the course of the trial. At the moment, there are almost 700 product liability lawsuits that are pending against Cook and Bard in connection with problems associated with some versions of their blood clot filters.
March 9, 2016 – No “Clinically Meaningful Benefit” In 91% Of IVC Filter Placements, Yale Researchers Find
IVC filter use continues to puzzle medical researchers. Most of the devices, around 91% actually, are being used in pulmonary embolism patients in stable condition, a group in whom filters show no “clinically meaningful benefit,” according to new research out of the Journal of the American College of Cardiology.
Analyzing Medicare data for patients 65 years or older, researchers at Yale discovered that 94,427 patients hospitalized for a pulmonary embolism between 1999 and 2010 had received IVC filters. Over the course of the 11-year study period, the number of patients hospitalized for PE increased reliably on an annual basis, but the rate of filter placement held steady. In other words, the number of patients receiving IVC filters rose in step with the number of total patients being hospitalized for pulmonary embolism.
The same trend, however, was not observed in specific patient groups. Patients over 85 saw a large increase in IVC filter placement while African American patients saw a drop in the device’s usage. Doctors in the Atlantic South, states from Florida to Delaware, were more likely than doctors in Western states to opt for IVC filters in their treatment plans.
Whether or not IVC filters are helping anyone remains in question. The researchers noted that mortality rates fell between 1999 and 2010, in both patients with filters and those without. Patients for whom the devices may present most clinical benefit, those considered in unstable condition, only receive IVC filters 27% of the time, according to an editorial that accompanied the study’s publication.
February 16, 2016 – “Absolutely […] Should Have Been Recalled,” Says Filter Removal Expert
Dr. William Kuo, an associate professor at Stanford University’s Medical Center, has come to prominence among professional circles as an IVC filter specialist. The Stanford-educated physician even developed the surgical technique now used to remove the small, spider-like implants from patients. Since 2006, he’s “retrieved” over 1,000 of the devices, which have a notable tendency to break inside people, causing all sorts of damage.
Kuo even heads a special office at Stanford, the IVC Filter Clinic. He’s often a patient’s last hope when it comes to repairing the harm caused by a filter, or preventing further damage. It’s safe to say that Kuo has made his name, and any wealth that may go along with that name, on IVC filters – specifically ones manufactured by Indiana’s C.R. Bard, Inc. But that hasn’t stopped Dr. Kuo from coming out against the devices in a big way.
In a recent interview, Kuo said:
“all of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications. The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”
He’s now advocating for a recall. In fact, he says the FDA and manufacturers had a “moral obligation” to recall IVC filters at the first sign of trouble, according to The Ring Of Fire, a prominent watchdog media service.