Category Archives: IVC Filter

(March 8, 2019) A shocking report from Kaiser Health News has found that the FDA hides thousands of medical device problems from patients and their doctors.  The FDA has, for nearly two decades, allowed medical device companies to file reports of injuries and malfunctions outside the well-known public database known as MAUDE, Manufacturer And User Device Experience Database.  The FDA, in effect, has been shown to keep separate sets of books: one, a heavily-censored and incomplete public set accessible to patients and providers; the other, a private and more complete (and therefore more relevant) set accessible only to some medical device manufacturers.

 “No matter how cynical you get, you just can’t keep up.”  – Lilly Tomlin

“Alternative Summary Reporting” Subterfuge

The FDA’s bookkeeping subterfuge – which the agency euphemistically calls “alternative summary reporting” – seriously compromises any legitimacy the FDA and MAUDE may have offered, which is an alarming development, to say the least.  Many medical experts have trusted the FDA and MAUDE to identify problems that could put patients in peril.

FDA records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017. That means no doctors or patients saw those reports, or that they saw only a tiny fraction of them if they were similar to other reports made on the same type of device.

Dangerous Devices Lead to Secret Program

According to officials with FDA at the time, “alternative summary reporting” began two decades ago to cut down on redundant paperwork.  Former FDA official David Kessler said the program took shape after scandals over under-reporting of device problems spurred changes that allowed criminal penalties against medical device companies.

Thousands of injury and malfunction reports began coming to the agency each month. Kessler said some 15 staff members reviewed them. He said many reports were so similar that reviewing them individually was “mind-numbing.”  Kessler went to the FDA’s legal department and to device makers for a solution.  Medical device makers then wrote their own ticket; they would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year, or year. Nobody but the FDA would be able to put the actual injury numbers together after that, or the total number of adverse events.  The agency would no longer share those real numbers with the public, with patients and medical providers.

Kessler said reviewers could then quickly look for new problems or spikes in known issues. (They would no longer be bogged down by actual reports, real numbers, total adverse events and injuries that were “redundant.” ) When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, according to Kessler.

Few people even within the FDA knew about the program then or now, and that list Kessler mentions as being public then is no longer public. We do know, however, that transvaginal mesh makers are now part of it, able to hide the actual number of women injured by the controversial plastic mesh used for pelvic organ prolapse and stress urinary incontinence.

Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.

The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.

FDA Unplugged

The Kaiser Health News story suggests the FDA’s reporting deception was not uncovered until a surgeon performed his due diligence after a device he had used failed.

“Special Exemption” 

Dr. Douglas Kwazneski experienced a stapler malfunction during a liver surgery.  He then researched other possible adverse events involving the stapler.  He checked the FDA’s MAUDE database.  He found “there was nothing.”   But then he surveyed leading surgeons.  Two-thirds of them told him they had also experienced stapler malfunctions, or they knew a peer who had.

Dr. Kwazneski then discovered that the FDA had granted the makers of surgical staplers a special “exemption.”  This arcane arrangement allowed the device maker to file reports of malfunctions in a database hidden from both doctors and the public.

FDA Covers up 1.1 Million Events 

“[I]t seemed like a coverup,”  said Dr. Kwazneski, who practiced at the time in Pasco County, Florida.

Worse, the KHN investigation shows FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions.  At least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository since 2016.  They all but disappear there, instead of being described individually in the publically accessible MAUDE database.

The hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA. Many of those were implanted in patients or used in thousands of surgeries. The adverse event reports for surgical devices have included surgical staplers, balloon pumps for blood circulation, and mechanical breathing machines.

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.  “Voluntary?”

Secret Program

KHN notes that the FDA’s secret reporting program has been so obscure that many of the doctors and engineers dedicated to improving device safety don’t even know about it. Even a former FDA commissioner said he knew nothing about it.

Give the Kaiser Health News team all the credit.  They dug through abstruse piles of public records to find “oblique references to reporting exemptions.”  They had to ask the FDA questions for months before the erstwhile “public” agency finally confirmed that it supervised “reporting-exemption” programs and helped hide thousands of never-before-acknowledged instances of malfunctions or harm.

FDA Information Blackout Harms People

FDA records show that amid the agency’s blackout on information regarding device risks, patients have been injured, in some cases hundreds of times.

A former FDA official. Dr. Lori S. Brown, who accessed the data for her research, said doctors who relied solely on the FDA’s incomplete public reports could easily reach the wrong conclusion about a device’s safety record.

KHN wrote, “The FDA has also opened additional – and equally obscure – pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.”

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations.  “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

That’s hardly the stuff to build consumer confidence about medical device safety.

480,000 Hidden Reports in 2017

FDA records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

FDA spokeswoman Alison Hunt said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a “placeholder” report to be filed publicly.

1 Million+ Reports Hidden by FDA

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA.  But with the agency’s alleged new “transparency” push,” anyone unlucky enough to need a medical device (there are always alternatives)  might be able to find a public report and submit a Freedom of Information Act request to get information about incidents.  A response can take up to two years.

Ms. Hunt said in an email to KHN that the exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive.”

The “quality” of the FDA’s review of any medical device is so obviously compromised with the unveiling of the agency’s secret reporting program that such explanations would be laughable if the situation it has created weren’t so dangerous and irresponsible.

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(Feb. 9, 2019) — An IVC filter company, Cook Medical, was hit with a $3 million verdict on Feb. 1 by an Indianapolis jury.  The jury returned their verdict just before midnight Friday.  They ruled that the Cook filter placed inside the plaintiff was defective.

Cook Celect Filter Trial

The case involved a 51-year-old dental hygienist whose Cook Celect inferior vena blood clot filter fractured and migrated in her body, eventually poking through her thigh and requiring open laparotomy surgery to remove.

Surgeons placed the controversial filter – which is alleged to trap blood clots – into the woman’s inferior vena cava March 2009 during lumbar spine surgery.  She complained in the next few months about hip pain, severe abdominal pain, and pain and swelling.

A CT scan in June 2011 showed her IVC filter had fractured in a prevertebral location abutting the anterior aspect of the L2-3 disc space and upper L3 vertebral body.  A follow up visit found  a “palpable mass” in the skin under her right leg.  The next day the woman pulled a 2-inch long metal object from her right thigh.  That object was part of the filter which had fractured inside of her vena cava and migrated.

In July 2010, surgeons attempted to remove the broken IVC filter but were unsuccessful.  Then, finally in October 2015, surgeons were able to remove what was left of the filter device.

Texas State Court Loss was Cook’s first

The troublesome filter in the Indianapolis trial concerned Cook’s “Celect,” which was also the subject of a jury trial and a subsequent verdict against Cook last Spring in Texas.

In May 2018, a state court jury awarded a Houston-area firefighter $1.2 million for a defective Cook Celect blood clot filter.  The case was similar in that the person implanted with the filter required open laparotomy surgery to have it removed.  And like the woman in this latest case, the plaintiff had it removed because it had migrated to where he feared it working like a “ticking time bomb” in his chest.

In the only other Cook IVC case to go to trial, an Indianapolis jury denied a woman’s claim for damages in summer 2017.  But in that case – a defense pick for trial – surgeons had been able to successfully remove the filter without resorting to open laparotomy surgery.

IVC Filter Problems

IVC filters have proven troublesome because even though they are often used as medical devices in the hopes that they will prevent DVTs, much evidence suggests that they don’t pass a risk-benefit analysis which is the gold standard of any medical device treatment.  Much evidence suggests that they have become accepted despite lacking evidence of being worth their risks.

IVC Filters give no benefit for Trauma Patients

Even though they are often used in trauma patients without the patients’ consent, there is no evidence that they offer trauma patients any benefit and are worth their risks.

No Long-term Benefits

Evidence has also shown that the longer removable IVC filters remain inside a patient’s vena cava, the more likely they are to cause problems.

In addition, evidence suggests that IVC filters don’t protect the patient from developing deep vein thrombosis (DVT) as well as their makers claim they do, while at the same time they can cause other problems which one who opts not to have a filter installed would not otherwise experience.

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Medscape commentary published August 7, 2018 declares that IVC filters need randomized controlled trials (RCTs).  Authored by Vinay K. Prasad, MD MPH – a hematologist-oncologist – the opinion piece explains exactly what RCTs are and why we need them for IVC filters and other medical devices.

Dr. Prasad penned the piece after reading a Twitter debate over whether we should run an RCT of the inferior vena cava (IVC) filter for patients with a venous thromboembolism (VTE) and a contraindication to anticoagulation.  Like so many runaway Twitter debates and diatribes, it was apparently fraught with ill-informed people flinging knee-jerk opinions before even clarifying the terms which made them butt heads.

The associate professor of medicine at Oregon Health and Science University explained that there are two basic prerequisites for a product requiring a randomized control trial.

First, he explained, randomized controlled trials are for interventions that are thought, or hoped, to offer benefits.  He contrasted them with devices or inventions which we know need no control group for comparison.  He offered examples such as smoking, drinking battery acid, falling off a bicycle, or getting kicked by a horse.  We don’t need a control group of people who don’t smoke, drink acid, fall off a bike, or get kicked in the head to know those things are bad. By contrast, we run randomized trials when we don’t know whether or not an invention, like an IVC filter, leaves us better off by using it than if we had avoided using it.

Second, Dr. Prasad points out, randomized trials are run for interventions that, at best, offer modest to medium benefits.  Again by contrast, if we know a light switch is beneficial, then we don’t ask or run RCTs.  Or if jumping from a plane with a parachute saves us vs. not using a chute, then we don’t need an RCT to test parachute vs. non-parachute jumpings.

RCTs in Medicine

To run or not to run an RCT gets most controversial when we consider medicine and medical devices.  RCTs are mentioned so often in medicine, explains Dr. Prasad, because “medicine lives in the ‘RCT zone.’”  Dr. Prasad explains, “Most of what we do involves offering interventions thought to benefit our patients, and most of what we offer confers a modest benefit, at best.”

Here’s where it gets interesting, and troubling.  The evidence shows that most medical practices are not beneficial for mortality.

1 in 80,000 Medical Practices Benefit Mortality

Dr. Prasad wrote:  “Data support the idea that medical treatments rarely have large benefits. Researchers studied every medical practice in the Cochrane database and found that only 1 in 80,000 practices had a very large, consistent benefit on all-cause mortality.”  Extracorporeal membrane oxygenation (ECMO) for neonates was the only one in 80,000 practices that showed a benefit for mortality!

Meanwhile, doctors have for years touted a list of practices with overwhelming benefit but lacking RCTs; that list includes just a few hundred items. That woeful number starkly contrasts with the hundreds of thousands of interventions and practices performed in biomedicine.

However, says Dr. Prasad, that doesn’t stop experts from pretending their “pet intervention” is an indispensable parachute and touting it as such.  The IVC filter is one such medical invention touted as a parachute, though no studies have proven that it is, or has ever been anything of the sort.

Dr. Prasad points to a recent paper in JAMA Network Open, in which Turner and colleagues found the IVC filter associated with an increased risk for death when used in patients with venous thromboembolism and a contraindication to anticoagulation.  That is especially troubling because that is the one group for which guidelines consistently recommend IVC filter use.

After adjusting for a common problem in observational data called immortal time, the authors found IVC filters associated with increased mortality (hazard ratio, 1.18; 95% CI, 1.13-1.22; P < .001). Dr. Prasad acknowledges that this study has limitations like all observational studies, but says we don’t have RCTs to guide us on this question.

Three randomized trials of IVC filter placement to date have included at least 100 participants, and none show a mortality benefit, even with extended follow-up. Curiously, all trials excluded patients with a contraindication to anticoagulation, which is again the only group which guidelines consistently recommend use IVC filters.   Additionally, said Dr.Prasad, “[O]ne of the three trials used an odd methodology that screened patients for symptoms of pulmonary embolism (not letting clots present on their own). 

Studies Show No Benefit for IVC Filters in Any Setting

“[T]he available evidence base for IVC filters is lousy,” declares Dr. Prasad.  “All observational studies have limitations—in this case, the patients who got filters may be different from those who did not; and these differences, and not the filter itself, may be responsible for any findings—and we may not be able to adjust for all of these factors. Moreover, all of the relevant RCTs are small and limited, and none show a clear benefit for filters in any setting. And there are no studies in the setting of contraindication to anticoagulation—a common reason why filters are placed.”

IVC Filters Need Randomized Controlled Trials

RCTs are needed for IVC filters because we only hope, but do not know, whether they benefit people.  IVC filters are costly, invasive, and harmful; and they’ve now been shown to offer no mortality benefit to the only group of people for which they are consistently recommended by common medical practice.

Something is terribly wrong with a system that allows a product to be implanted by the hundreds of thousands into people with no evidence of benefit.  Consequently, problems with IVC filters have led to IVC filter lawsuits being filed all across the country.

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(July 16, 2018)  A new study questions the use of IVC filters in DVT patients undergoing CDT, catheter-directed thrombosis. The study led by Temple University showed no in-hospital mortality benefit, and worse.  It  showed IVC filters associated with increased procedure-related hematomas, and it also showed that using IVC filters led to lengthier hospital stays and higher bills.

Related:  Cook Medical loses $1.2 Million Verdict

IVC filters are alleged by their makers to help treat DVT, deep-vein thrombosis.  They are advertised – by Cook Medical, C.R. Bard, and other IVCF makers – to be indispensable, life-saving devices.  But their effectiveness in every regard has been questioned by thousand of IVC filter lawsuits.

DVT occurs when blood clots develop in the deep veins of the legs, thigh, or pelvis.  These clots can break loose, travel to the lungs, and cause life-threatening pulmonary embolism (PE).  Proximal DVT – a clot in the thigh or pelvis – has been linked with a higher risk for post-thrombotic syndrome.

Post Thrombotic Syndrome (PTS) and Catheter-Directed Thrombosis (CDT)

PTS is a painful condition characterized by swelling, redness, and leg sores.  In hopes of reducing the high incidence of PTS in patients treated solely with a blood thinner, many doctors today use catheter-directed thrombolysis.  CDT is a minimally invasive procedure in which an infusion catheter delivers clot-busting drugs directly into the clot.  Fluoroscopically guided, CDT can potentially reestablish blood flow through a newly-blocked vein.

In hopes of preventing clots from breaking loose and migrating to the lungs during a CDT procedure, some doctors choose to simultaneously implant an inferior vena cava filter (IVCF).  IVCFs are wire-basket-like devices inserted into the inferior vena cava, a large vein that returns blood from the lower body to the heart and lungs.  IVCFs are used on the theory that they capture blood clots which would otherwise reach the lungs. There is some evidence, which has been produced by IVC filter makers, to support the IVCF theory; but it is scant, at best, and far from convincing, which has led to IVC filter lawsuits.

Any IVC Filter Benefit is Unclear

A research team led by Riyaz Bashir, MD, FACC, RVT, Professor of Medicine at the Lewis Katz School of Medicine at Temple University (LKSOM), and Director of Vascular and Endovascular Medicine at Temple University Hospital (TUH), sought to address the question of whether there is any benefit of IVCF placement at the time of CDT.  The team began by examining nationwide utilization rates of IVCFs in patients undergoing CDT.  They wanted to assess contemporary trends and compare outcomes with patients who do not undergo IVCF placement. The team’s findings were published online July 16, 2018 and also in the July 23rd issue of the journal JACC: Cardiovascular Interventions.

Limited Data for IVCF Patients – 7 Years

“Limited data exists on the effectiveness of IVCF use in patients undergoing CDT for the treatment of proximal DVT,” said Dr. Bashir. “This study is noteworthy because it is the first to evaluate national trends and comparative outcomes related to this practice.”

The research team used the National Inpatient Sample database to identify every person in the U.S. with DVT who underwent CDT (with and without IVCF placement) from January 2005 to December 2013.

The team’s findings include these conclusions:

• IVCF used in patients undergoing CDT for DVT was not associated with any significant in-hospital mortality decrease compared to patients who did not receive an IVCF.
• IVCF used in patients undergoing CDT for DVT was associated with an increase in procedure-related hematoma formation (3.4% vs. 2.1%), in-hospital costs ($104,049 vs. $92,881) and length of stay (7.3 days vs. 6.9 days) compared to patients who did not receive an IVCF.

Dr. Bashir said that based on these results, his team believes, “IVCFs should not be routinely placed in patients undergoing CDT.”  Dr. Bashir also called for more well-designed, randomized control trials “to elucidate the implications of IVCF placement in patients undergoing CDT.”

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(May 25, 2018)  .2 Million IVC Filter Verdict">Cook Medical must pay $1.2 million to compensate a man who was implanted with a Cook Celect IVC filter, said a Texas jury Thursday.  Following a three-week trial, the jury of 12 ruled Cook must pay for injuries following a Celect filter’s implantation in Jeffrey Pavlock on March 3, 2015.   A 35-year-old Houston-area firefighter,  Mr. Pavlock sued Cook after its Celect inferior vena cava filter became stuck inside him and required open laparotomy surgery to remove.

Cook promoted its Celect IVC filter as retrievable, but the filter put into Mr. Pavlock’s inferior vena cava tilted, perforated his IVC, duodenum and aorta, and was pressing against his spine and renal artery.  That situation made it impossible to remove without major surgery. Two previous removal procedures had failed.

Much conjecture from both sides argued about how much the results of the removal surgery affected Mr. Pavlock now and could affect him in the future. For the present, despite the scar hidden beneath the button-down shirts he favored during the trial, the appearance of the burly firefighter and EMT appeared unremarkable.  He moved freely throughout the proceedings, without any apparent pain or visible injury, in full view of the jury just a few feet away.

One plaintiff’s expert in the case testified that Mr. Pavlock had a 90% chance of suffering future spinal stenosis from the surgery which involved cutting the metal filter into several pieces and digging them out.

”Spinal stenosis,” according to the Mayo Clinic, “is a narrowing of the spaces within your spine, which can put pressure on the nerves that travel through the spine.  Spinal stenosis occurs most often in the lower back and the neck. Some people with spinal stenosis may not have symptoms.”

Defense pounced on the Plaintiff side’s analysis that any spinal stenosis Mr. Pavlock may have is asymptomatic for now but could become symptomatic in the future. Nobody could say for certain whether or not Mr. Pavlock would suffer symptomatic stenosis in the future.

Attorney David Matthews argued for the plaintiff in closing that Cook knew its Celect had perforation problems before it was cleared by the FDA, yet pushed it to the market anyway.  He showed the jury several independent studies which found Celect had a perforation rate of greater than 79 percent, while the Cook-sponsored study the company presented to the FDA prior to Celect’s 510(k) clearance in 2008 showed a zero percent perforation rate.  Mr. Matthews also reminded the jury that he had showed evidence that as few as one percent of adverse events are reported by doctors to a medical device company.

Concerning the large gap between independent- and Cook-sponsored study findings, defense attorney John Mandler said, “They have their favorite studies and we have ours.”  Cook’s lawyers had also refuted trial evidence of doctors reporting only 1-5% of actual adverse events related to medical devices.  In closing, Mr. Mandler called the low-reporting evidentiary studies a “conspiracy theory.”

Cook issued a press release the next day vowing to appeal the jury verdict.

Cook Medical loses $1.2 Million IVC Filter Verdict

Freese & Goss and Matthews & Associates Law Firm represented the plaintiff. Cook Medical was represented by Faegre Baker Daniels of Minneapolis.  The actual jury award was $1,240,500.

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Dubious medical devices like IVC filters, heart stents, and metal-on-metal hip implants are allowed on the US market through some very questionable means. Most people assume the U.S. Food and Drug Administration extensively tests all medical devices before blessing them with the agency’s magic wand of approval. The fact of the matter is far different. The FDA performs no studies of its own. The FDA merely evaluates research that is usually submitted by medical device and drug makers with a vested interest in that research. The FDA hasn’t the time, the funding, or the personnel needed to do the job entrusted to it, the job that most Americans assume it is doing.

The FDA has – through budget cuts and restructuring of its funding, political pressures from Big Pharma lobbyists, and a revolving door which shuffles drug and medical device company employees in and out of FDA employment – now become little more than a pawn for medical device and drug makers. Medical device companies making billions of dollars on dubious devices – like overused IVC filters, over-prescribed heart stents, and dangerous metal-on-metal hip implants – use the FDA primarily as a cover. They use the agency to imply that it has verified the safety and efficacy of their medical devices, and to help them sidestep liability lawsuits.

Full FDA approval can and does help medical device makers sidestep many liability lawsuits; however, FDA approval does not verify the safety and efficacy of medical devices.

The Danger Within Us: America’s Untested, Unregulated Medical Device Industry
This is not Conspiracy Theory 101. This is the fact of the matter, and it is well documented in at least a dozen extensively-researched books. One of the latest, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, by Jeanne Lenzer, makes the case all over again.  Ms. Lenzer shows just how broken our medical regulatory system is.  The book should be required reading for the U.S. Supreme Court, which has ruled in some landmark cases that FDA approval grants medical device makers a free pass to harm people at will with poorly tested or even arguably worthless medical devices.

Despite the woeful state the FDA has been left in after billions of Big Pharma lobbying dollars have worked to undercut and weaken it, the U.S. Supreme Court has ludicrously ruled that FDA approval of a medical device gives its maker license to avoid legal responsibility for injuring people.

Riegel v. Medtronic:  Justice Denied by Preemption

In Riegel v. Medtronic and other miscarriages of justice, the highest court has ruled that medical device makers get a free pass when they make a device that injures or kills someone, if that device was approved by the FDA.  The ruse is called “preemption.” It adds an additional injury to people whose lives were taken entirely or perhaps only badly damaged by some dubious medical device. The preemption argument, in a nutshell, claims states can’t comply with both federal and state laws; therefore, federal laws “preempt” state’s rights.  Preemption is a Sophist argument easily refuted on both legal and ethical grounds by anyone (such as Justice Ginsburg) who believes in civil liberty, corporate responsibility, and the U.S. Constitution. But all is not lost, yet.

Medical devices which have not gone through the FDA’s full PMA approval process are still fair game for liability lawsuits. That is at least the case for now, though several bills written by medical device and drug company lobbyists are currently being pushed by Big Pharma’s lackeys in congress. The obvious goal for the Western medical “industry” is to remove all vestiges of remaining protections for people injured by dangerous drugs and medical devices. Unfettered profits with zero accountability has always been the goal of every corporation, of course, but in the case of the healthcare “industry,” that goal strikes one as especially unmoored from any basic semblance of human decency.

Related: 21st Century Cures Act a Disguised Handout to Drug Companies

The FDA 510(k) Clearance Process
But even in today’s wild west of a healthcare system broken both legally and morally, medical device makers can sometimes still be made to face some legal liability. Medical device makers can still sometimes be held accountable if, rather than gaining full FDA approval for the device in question, it was allowed on the market via the FDA’s 510(k) clearance process. The 510(k) clearance process has so lowered the bar to the open market that even the corporate-friendly judges of the high court have been forced to see that it does not even imply that the FDA has researched the product sufficiently to ensure its safety or effectiveness.

IVC Filter Lawsuits

Because IVC filters were allowed on the market via the FDA’s 510(k) clearance process, IVC filter makers like Cook Medical , C.R. Bard, Cordis, and Rex Medical can still be held accountable when their filters fail to perform as advertised.

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(April 18, 2018)  The first Cook IVC filter lawsuit to be tried in state court in the U.S. will begin on May 7, 2017 in Houston, Texas.   The plaintiff is a Texas firefighter who has brought suit against Cook Medical Inc., based in Bloomington, Indiana.  He is represented by David Matthews of Matthews & Associates Law Firm, in Houston, as well as Tim Goss of Freese and Goss in Dallas, Texas.  The trial is expected to last two weeks.

The lawsuit petition states that the plaintiff was surgically implanted with a Cook Celect inferior vena cava filter at Methodist Hospital.  On or about April 23, 2015, surgeons attempted to remove the Celect IVC filter but were “unsuccessful because the filter had tilted and become embedded in the wall of Plaintiff’s inferior vena cava.”

The vena cava is the blood vessel located beneath the heart which returns blood to the heart from the lower body.

Relevant facts regarding IVC filter removal as stated in the petition show the difficulty of removing the filter from the plaintiff.

Attempts to remove Plaintiff’s Celect IVC Filter
Approximately two months after the Celect filter was implanted, an interventional radiologist  attempted to remove it.  He was unable to remove the filter because it had tilted and the tip was embedded into the wall of Plaintiff’s vena cava.  After multiple unsuccessful attempts to retrieve the filter via access through Plaintiff’s jugular vein, he aborted the procedure.

In June 2015, another jugular removal procedure was attempted by an interventional radiologist. In connection with this attempted removal, imaging revealed that at least two of the filter legs had perforated through the wall of Plaintiff’s vena cava. This retrieval attempt was also unsuccessful.

Finally, on July 20, 2017, Plaintiff had a life-threatening, invasive open surgery to remove the perforated Cook IVC filter. During the open removal surgery, it was determined that Plaintiff had at least three IVC filter legs poking outside of his vena cava: one in his duodenum (bowel); one beginning to perforate his aorta; and one inside his lumbar vein, which had to be resected for the filter leg to be removed. The degree to which Plaintiff will recover from surgery, and the lingering effects of the perforated filter struts, has yet to be determined.

The petition further alleges that the plaintiff is now at risk for future migrations, perforations, and/or fractures from the retained filter.  He also faces numerous other health risks, including increased risk of clots and risk of death.  He will “require ongoing medical care and monitoring for the rest of his life and may ultimately require additional surgery in an attempt to remove the filter.”

The lawsuit petition alleges that the implanting doctor knew or should have known, inter alia, several things, including that:

• only certain patients were appropriate candidates for an IVC filter.
• the longer a Celect IVC filter remains in the body, the higher the risk of device fracture or failure.
• the Celect filter is not effective to prevent clots and/or increases the risks of clots.
• safer alternatives to the Celect IVC filter existed.
• IVC filters, such as the Celect filter, should not be used in certain patients, such as the plaintiff.

Cook Celect IVC Filter Problems
The petition alleges that Cook Celect filters frequently tilt, migrate, perforate or fracture and thus, involve a high and increasing degree of risk to a patient who has been implanted with a Celect filter.

The petition further claims that Cook knew or should have known that the Celect device was defective and unreasonably dangerous for several reasons, inter alia, including:

•   Cook failed to conduct any clinical testing, such as animal studies, to see how the device would function once permanently implanted in the human body;

•  The Celect filter had a high rate of fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted. Such failures exposed patients to serious injuries, including: death, hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia and other symptoms similar to myocardial infarction; severe and persistent pain; perforations of tissue, vessels, and organs; inability to remove the device;

•  Cook knew or should have known that certain conditions or post-implant procedures such as morbid obesity or open abdominal procedures could affect the safety and integrity of the device;

•  Cook knew or should have known these risks for the Celect filter were and are substantially higher than other similar devices;

•  Cook knew or should have known the Celect filter contained conditions which resulted in the device not performing as safely as the ordinary customer would expect;

•  Despite being aware of these risks, Cook misrepresented, omitted, and/or failed to provide adequate warnings of these risks or instructions for safe use;

•  Cook failed to issue a recall of the Celect filter or otherwise notify consumers that a safer device was available.

IVC Filters
IVC filters first hit the medical market in the late 1960s. Several different medical device makers, including C.R. Bard, have introduced several different designs.

IVC filters are allegedly designed to filter or “catch” blood clots (called “Thrombi”) that travel from the lower portions of the body to the heart and lungs. The filters are designed to be implanted either permanently or temporarily within the vena cava.

The inferior vena cava is a vein that returns blood to the heart from the lower portions of the body. In certain people, for various reasons, thrombi travel from the vessels in the legs and pelvis, through the vena cava and into the lungs. These thrombi often develop in the deep leg veins. They are called “deep vein thrombosis” or “DVT.” Once they reach the lungs they are called “pulmonary emboli.” Pulmonary emboli present grave risks to human health, including the risk of death.

Someone who undergoes knee or hip joint replacement is at risk for developing DVT/PE. Obese patients are also at risk. So too are those who have vascular diseases, or those who have experienced previous strokes. Several other conditions also predispose some people to DVT/PE.

At-risk people may be prescribed medications like Heparin, Warfarin, or Lovenox to regulate the blood clotting factors. Some at high risk who cannot manage with medications may receive an IVC filter in an effort to prevent thromboembolic events.

Wide Use with no Evidence of Efficacy
IVC filters have been implanted by the hundreds of thousands despite there being no reliable evidence which proves their safety and effectiveness. No evidence proves that IVC filters are worth their risks.

Evidence of harm without evidence of benefit
A 2013 paper published in the Journal of the American Medical Association by Vinay Prasad, MD and others offers a stern critique of IVC filters. The authors declare, “While the benefits of the IVC filter are hard to assess, the complications are evident.”  They conclude their paper with a warning: “Follow current standard of care and place filters where guidelines advise, or do not place filters, after informed consent informs patients that there is evidence of harm without evidence of benefit.”

First Cook IVC Filter State Trial
The Houston trial is expected to last two weeks.

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•  Cook IVC Filter Attorney
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IVC filter lawsuits are being filed because the preponderance of evidence fails to show that IVC filters are worth their risks.  We are consequently filing IVC filter lawsuits across the country.  Matthews & Associates Law Firm will try the first Cook IVC lawsuit in state court in the country in a trial beginning May 15, 2018 in Houston, Texas.

IVC filter makers such as Cook Medical and C.R. Bard sell fear, first, in order to promote their products.  They always point to the dangers of pulmonary embolism, and claim IVC filters are the only answer to PE when someone is contraindicated for blood-thinning medication.

Pulmonary embolism is undoubtedly a problem, for a reported 422 of 100,000 people in the United States. Left untreated, PE will occur in as many as 40% of all people who develop proximal deep vein thrombosis (DVT).

But identifying a problem doesn’t mean you’ve solved it, or even offered the best solution. Significant controversy surrounds the “appropriate indications” for IVC filter placement. Scientific literature regarding the safety and efficacy of IVC filters is woefully lacking.

Related: IVC Filters risk serious complications

All published guidelines agree IVC filters are indicated in patients who have an acute VTE and cannot receive anticoagulation medications.  Or they are indicated for those whom adequate anticoagulation has clearly failed despite evidence of appropriate use and effect.  Nevertheless, some indications are much more controversial.

Dr. Ido Weinberg and others pointed out in a 2012 IVC filter paper, Cardiovascular Interventions by the American College of Cardiology Foundation, that IVC filters are inserted perioperatively in patients undergoing surgical pulmonary embolectomy. The intent is to reduce the effect of post-surgical PE in this unstable population. In a retrospective analysis of mortality in 520 such patients who were unstable secondary to PE, and who underwent embolectomy – all of whom received an IVC filter – mortality was lower than in 430 patients who received no filter (25% to 58%). The authors wrote that other safety data are conflicting, yet the Society for Interventional Radiology guidelines and ACR appropriateness criteria inexplicably offer that data as a relative indication for placing an IVC filter.

IVC filters are also advocated for high-risk populations without VTE as a prophylactic measure, such as in trauma patients. But several points of controversy apply. First, placing a filter can add complications that include increased morbidity.  Second, patients are at risk for long-term complications if filters are not removed.  Third, studies have shown IVC filters are a poor choice for trauma patients.

IVC filters have also been advocated for people undergoing elective open gastric bypass surgery. Those who received the filters have not been shown to fare any better than those who did not. In fact, studies have shown IVC filter risks outweigh benefits for bariatric patients.

IVC filters are sometimes used in high-risk patients in conjunction with anticoagulation therapy. In a comparison of 251 patients who received both an IVC filter and anticoagulation meds, and 1,377 who received only anticoagulation, there was no difference in PE incidence at 90 days and 5 years, though a trend toward more DVTs in the IVC filter group.

Cochrane Review: compression and anticoagulation effective and safe
Dr. Weinberg and the authors write that, “It is noteworthy that a Cochrane review of combined intermittent compression and anticoagulation for VTE prevention in high-risk patients showed the combination to be effective and safe.”  Which would seem to seriously challenge the notion of IVC filter makers that their filters are the only option in town for high-risk patients.

Do IVC Filters prevent PE?
A population-based study analyzed hospital records from 1991-1995.  It found that the rate of rehospitalization for PE did not decrease with the use of IVC filters. Rehospitalizations for DVT, however, did increase with the increased filter use. Further, Cochrane database investigators could not draw firm conclusion as to whether the filters decreased PE at all.

IVC filter lawsuits filed against Cook and Bard argue that these companies did no relevant long-term studies which randomized patients to find the true effectiveness of their filters. They diligently avoided performing those tests because they knew their IVC filters had no true effectiveness, and that IVC filter benefits are often not worth their risks.

IVC Filter Risks
IVC filters can become embedded in the vena cava. They can also break apart, and their various pieces can travel to the heart, lungs, nearly anywhere the blood can take them in the human body. They have not been proven efficacious. They are decidedly dangerous, and that is why you see so many IVC filter lawsuits filed in state courts and in federal multi district litigation courts across the country.

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