Why Do IVC Filters Fail?

ivc filters lawsuit lawyers

IVC (inferior vena cava) filters were initially developed as an ideal alternative for individuals who were at risk of deep vein thrombosis (blood clots) but not able to handle anticoagulant medications. Coupled with the risk of anticoagulants increasing the probability of serious internal hemorrhaging, IVC filters were seemingly set to revolutionize the manner in which patients deal with blood clots.

This didn’t happen. Instead, the small metal cage medical devices have exhibited a propensity to fail.

The attorneys at Hotze Runkle PLLC are committed to helping those who have suffered harm at the hands of others.  Your injury and pain deserves justice. Let our legal representatives serve your needs and provide you with the commitment of a team that can get the job done.

IVC Filter Failure

The inferior vena cava is the largest vein in the human body and carries de-oxygenated blood from the lower extremities up to the heart and lungs. Certain patients who have undergone hip or knee surgery may be at risk of pulmonary embolism (blood clot traveling to the lung), which can cause breathing difficulties, chest pain, and even have fatal consequences.

IVC filters are small cone-shaped devices implanted in the inferior vena cava, usually just below the kidney, designed to capture blood clots that are traveling upwards toward the heart and lungs. Ideally, IVC filters work by capturing the blood clots while still allowing blood flow to continue around the area, and over time, natural anticoagulants within the blood should help to break the clot down.

However, what has happened in many cases is that the filters fracture, or fall out of position altogether, causing severe, painful and life-threatening injuries. Failure rates vary by study, but most research done has shown incident rates to be high. For instance, one analysis of 262 patients found that IVC filter struts had pierced the inferior vena cava or other organs in 46% of cases.

Another study conducted at Ohio State found that out of 591 patients, there were 262 cases in which IVC filter perforation had occurred—a little over 44% of patients. Even more troubling, evidence suggests that failure will occur in up to 50% of patients over the course of five years.

If the IVC filter fractures, the small metal shards can perforate other organs, and can even reach the heart. If this occurs, an irregular heartbeat can develop, as fluid such as pus or blood leaking into the tissue lining surround the heart muscle can cause pressure and interfere with the heartbeat.

While the medical devices appear to work effectively within the first few months of implantation, the longer the IVC filter remains in the patient’s body, the greater the chances of failure. Furthermore, the longer it remains in the patient, the more difficult it becomes to surgically remove the device.

Why do IVC filters fail?

Research conducted by Baylor Scott & White Health’s Department of Radiology in Dallas have determined that over time the metal of the IVC filter causes a reaction in the tissue of the arterial walls. Evidently, the filter begins to grow into the arterial lining.

Another major contributing factor that causes many of the side effects found with IVC filter fractures is the flattening of the artery itself as the heart pumps blood. This motion of the artery places stress on the device and causes metal fatigue, eventually causing it to break.

There’s also the issue of the devices becoming hard to remove with the passage of time.

Because the filters can begin  growing into the arterial wall lining, it is highly recommended that the filters be removed with the first year, while there is still a high success rate of removal. This issue, in tandem with the IVC motion, can lead to a complicated retrieval or fracture.

Although the Food and Drug Administration has issued numerous warning about IVC filter failure, the device manufacturers such as C.R. Bard, Cook Medical, and Cordis, have continually failed to inform patients and doctors of the potentially deadly risks.

Let Hotze Runkle PLLC help you fight against the negligent acts of these manufacturers.

There have been thousands of lawsuits filed against the previously mentioned manufacturers. Their concern for profit above your physical well being and safety has to the FDA receiving 1000s of adverse event reports since the IVC filters were first introduced in 2005.

Hotze Runkle PLLC has an experienced team of lawyers who focus on medical device litigation. If you, or a loved one, has suffered a debilitating injury because of an IVC filter, contact us today at (877) 919-0830 for a free consultation.


New IVC Filter Removal Technique Emerges

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Blood clot filters, otherwise known as inferior vena cava (IVC) filters, are frequently implanted in the veins of individuals who are at risk of suffering a pulmonary embolism. The small, spider-shaped devices, while intended to provide protection against blood clots, have come under major scrutiny because of complications arising from their use.

A large number of reports in recent years have shown that the retrievable devices manufactured by C.R. Bard, Cook Medical, and other companies, are breaking apart within patients and traveling to the hearts and lungs, causing abdominal pain, as well as tears in the inferior vena cava. The probability of issues increases the longer the filter has been in place.

Until recently, retrieval rates of removable filters were abysmal and required invasive specialized techniques in order to remove them – and often requiring multiple surgeries. However, doctors at a Chicago hospital have reported that they have developed a new technique to retrieve hard-to-remove filters.

Radiologists at Rush University Medical Center (RUMC) have potentially found a solution

As reported in the November 2016 issue of Journal of Vascular and Interventional Radiology, a team of interventional radiologists from RUMC and Rush Oak Park Hospital claim they have achieved a 100% success rate at removing IVC filters that previously couldn’t be removed for various reasons. The technique is able to catch the filter, hold it in place, and then cover it to prevent any parts from breaking free.

Doctors noted that they had been performing this operation over the last five years with an impeccable success rate.

The minimally invasive procedure, which requires tools such as alligator forceps and a excimer laser, is performed on an outpatient basis using a mild dose of anesthesia. The operation takes place in a suite similar to an operating room, but which includes special imaging equipment. With X-ray guidance, the doctors are able to perform the removal through a small incision in the neck or groin.

This advanced retrieval method is vital to future IVC filter users, as the FDA urged doctors in 2014 to remove IVC filters within a month or two from individuals who were no longer at risk of suffering a blood clot. With thousands of IVC filter lawsuits filed in recent years because of manufacturers selling the device without adequately informing physicians or patients about the risk associated with leaving them in place, there is sure to be some relief in the medical community once the data is adequately reviewed and approved.

The FDA now recommends that all patients with an IVC filter should consult a specialist about having the filter removed as soon as possible. Even patients utilizing permanent filters should still seek an evaluation to ensure the device is working effectively and to ascertain that no complications have emerged.

IVC filter lawsuits

There are currently more than 1,000 Bard IVC filter lawsuits working their way through the federal court system under one judge who is coordinating pretrial proceedings for multidistrict litigation (MDL). There are also another 1,000 Cook IVC filter suits facing similar allegations in a separate MDL.

“Bellweather” cases are set to take place in 2017 and will help to set a precedent on how juries may respond to certain evidence and testimony. These outcomes will not be binding for other cases, but may likely influence IVC filter settlements that will be reached with the thousands of individual trials nationwide.

Have you or a loved one suffered through complications caused by an IVC filter? Let Hotze Runkle PLLC national litigation firm fight for the compensation and justice you deserve.

At Hotze Runkle PLLC, we are committed to helping those who have suffered harm at the hands of negligent and deceitful manufacturers. Your injury and pain deserves justice. Let our legal representatives serve your needs and provide you with the commitment of a team that can get the job done.

If you, or a loved one, have suffered physical, emotional, and financial injury, or even death, as a result of IVC Filters, then contact us today at (877) 919-0830.


Investigators explore potential causes for the fracturing of IVC filters

Potential Causes for the Fracturing of IVC Filters

The adverse effects of IVC filters have caused numerous patients to suffer from perforations to their vital organs, undergo life-threatening surgeries to remove the fractured pieces, and in worst case situations, some IVC filter users have perished. Medical professionals have concluded that if these medical devices are left implanted in a patient that is no longer at risk of a blood clot, the metallic components of the device can fracture and travel to vital organs in the body, causing internal lacerations and bleeding.

Numerous cases and studies have shown that the dangers associated with these medical devices outweigh their benefits, and investigations have raised the concern that two of the largest IVC filter manufacturers, C.R. Bard and Cook Medical, unlawfully misrepresented the efficacy and safety of their products.

Were you directly affected by the fracturing of an IVC filter? Do you know of anyone who has died as a result of vital organ perforations caused by these medical apparatuses?

Contact the law offices of Hotze Runkle PLLC toll free at (877) 919-0830.

A possible reason for the fracturing of these devices.

It was after a CT scan that indicated the intestinal rupture in an IVC filter user that medical professionals began to thoroughly evaluate the reasons why these apparatuses were fracturing and causing plenty of bodily harm to Americans. It appeared that the movement of the inferior vena cava vein itself was connected to reasons why IVC filters were breaking apart and internally perforating patients.

As per a study by Baylor Scott and White Health’s Department of Radiology in Dallas, it was found that the “foreshortening and flattening” of the inferior vena cava was the direct cause of the displacement of the IVC filters.

Plaintiffs argue that doctors are also at fault for IVC filter negligence.
In recent years, a vast number of cases associated with the fracture of IVC filters have come into suit, in order for patients to attain financial compensation, and justice, for their medical burdens caused by the negligence of various parties. Plaintiffs involved in IVC filter litigation have alleged that they were unaware of the life-threatening side effects of these devices and that the risks were never properly disclosed to them.

There have also been allegations against doctors and other medical practitioners involved in the implantation of IVC filters. One major concern has been the lack of removal of these devices in patients who are no longer in threat of blood clots. This inadequate concern about the long-term use of these devices has only increased IVC filter failure.

Other claims state that although IVC filters are used to decrease life threatening blood clots, specifically in patients who cannot receive conventional medical treatment, in many cases, they have been implanted regardless of the patient’s medical status.

What can we learn from these occurrences?

The most important thing to remember about the history of these faulty medical devices is that they can be unsafe, and may damage your overall health, especially when left implanted for longer than necessary. It is also crucial to understand that symptoms such as chest pain, lightheadedness, shortness of breath, and internal bleeding, should never be ignored, as they can be direct indications of an IVC filter complication.

At Hotze Runkle PLLC we care about the physical and financial status of our clients. We understand that circumstances of this nature are burdens that can completely change your lifestyle.

Let us represent your case today! Our success is built on a team of determined attorneys who are dedicated to the defense of our clients.

Contact us toll free at (877) 919-0830.


True Stories of IVC Filters Failing

Young woman sitting on the bed with pain
After 18 years, a woman learns that her IVC implant was the direct cause of an abdominal pain that could have turned fatal.

When Susan Karnstedt began to experience a swelling in her left leg and shortness of breath, she was immediately rushed to the emergency room, where she was diagnosed with a life-threatening condition – deep venous thrombosis and pulmonary embolism.

Susan understood that her condition was serious and was also aware that she needed to be placed on special treatments.

In 1992, doctors recommended the permanent implantation of an IVC filter; a seemingly safe treatment that would keep blood clots from reaching vital organs.

Nonetheless, in 2010 Susan felt the need to consult with a hematologist regarding her long term use of the Greenfield IVC filter.

To check that the filter was free of clots, and that blood was flowing properly through stents that had been placed in her iliac vein, a CT was performed.

The results were shocking and not what she expected.
Symptoms that signaled medical attention.
When Susan received her CT results, she was devastated to learn that her IVC filter had punctured her intestines.

However, prior to learning that she had been directly affected by this medical device, Susan lived with a chronic abdominal pain that she would describe as a “fork poking sensation”, but never imagined that her IVC filter would have a direct connection with the endless abdominal discomfort.

Susan began to worry that perhaps it was the foods that she consumed that were giving her such a hard time living a normal life. She even began to question whether she should continue her yoga routine and water skiing activities. She also claimed that her pain would worsen as days went by and described it as “debilitating.”

But it never crossed her mind that her IVC filter would be the cause of the agony she was experiencing.

How an IVC complication can make life difficult.

The perforation or migration of these devices have caused plenty of adverse effects through the years. In most cases, the pieces of this device have traveled to the lungs and heart, making it difficult for physicians to perform surgery on patients.

When Susan consulted with the doctors who had implanted her IVC filter, she was told that no one had ever retrieved a non-retrievable filter. They explained that if she did find a physician who would attempt the surgery, it would be unsuccessful.

Fortunately, Susan was able to have her IVC filter removed at Stanford Health Care. Her life was saved, but in many cases, IVC filters have caused death.

If you have a pre-existing medical condition, this risk can increase greatly.

Who to turn to for legal help.

The attorneys at Hotze Runkle PLLC know that a situation of this extent can be frightening and painful. We understand that a crisis can bring forth unexpected expenses that could have a direct effect on your way of life. But you do not have to carry these burdens alone. Let the team at Hotze Runkle PLLC fight for the compensation that will help you through a difficult time.

Call us today for a free consultation at (877) 919-0830


Bard G2 IVC filter produces more harm than benefit

ivcfilter-hotze-runkleDeep vein thrombosis (DVT) and pulmonary embolism (PE) are a common cause of death in America. Throughout the years, these conditions have been controlled by anticoagulation medication or by IVC filters when medication could be a contraindication. Unfortunately, numerous risks are associated with these treatments that are intended to prevent blood clots.

One of those risks involves the deterioration and migration of IVC filters with studies showing that these metal devices can produce more harm than benefit.

The Attorneys at Hotze Runkle PLLC understand that there is no financial compensation that can recover the loss of a loved one. We also know that pain associated with a traumatic event can never be mended. But we want to help diminish financial burdens placed on you because of the unscrupulous actions of manufacturers. Our attorneys are ready to fight for your case and bring you a positive resolution.

Call us today at (877) 919-0830 for a free consultation.

The Bard G2

A well-known and commonly used filter is the Bard G2. This filter was created by C. R. Bard to replace the Bard Recovery Filter, which was known to have a high number of fractures, and cause serious health issues when left implanted in patients longer than necessary. The Bard G2 was marketed as fracture and migration resistant, as well as having improved centering, but the effects of the device contradicted its promotion.

Approved by the FDA in 2005, the Bard G2 was not any less harmful, as numerous cases arose around fatalities linked to the device.

In 2010, published studies claimed that the Bard G2 had a 12% rate of filter fracture and migration. Patients who suffered these complications found that the device had traveled to the hepatic vein or the lungs.

Sufferers also experienced shortness of breath and persistent chest pains that required emergency medical treatment to determine whether the symptoms were connected to a heart attack or if they were related to filter fracture.

Bard G2 filters were sold despite their flaws.

Despite the issues and fatal cases associated with the Bard G2, manufacturers continued selling the product for five years until 2010, rather than removing them off the market. Approximately 160,000 Bard G2 filters were sold.

Doctors who have dealt with this IVC filter have frequently expressed to patients the dangers of the device and have notified them that the filter frequently fractures and migrates to vital organs.

In numerous scenarios, patients whose filter had migrated to the heart or lungs were at greater risk for an unsafe surgery. In many cases, physicians preferred not to retrieve the device so as not to subject patients to the associated risks.

Doctors and medical practitioners across the country have questioned whether the FDA will effectively regulate products that are dangerous for patient use, and have expressed their disappointment that medical companies are not considering the lives of patients.

When to seek medical attention.

There are various symptoms that can be explicit signs that a patient has been seriously affected by an IVC filter including:

  • Constant pain in the heart or chest
  • Feeling anxious
  • Respiratory insufficiency
  • Pulmonary embolus
  • Hemorrhages
  • Perforation of organs, tissues, or blood vessels

Hotze Runkle PLLC has an experienced team of lawyers who focus on medical device litigation. If you, or anyone you know, have suffered a debilitating injury because of the Bard G2, give us a call today at (877) 919-0830 for a free consultation.


IVC Filter Complications

ivcfilter
An Inferior Vena Cava (IVC) filter is a metal device that is implanted in the vena cava vein to prevent life threatening pulmonary embolism (PE), which is a condition in which blood clots make their way into a patient’s lungs. PE is often treated with anticoagulation medication like Xarelto, however in some cases, blood thinners are counterproductive and can actually bring about harmful results. Therefore, physicians use IVC filters to decrease the risks associated with PE.

IVC filter complications occur in long term use.

As per the Food & Drug Administration (FDA), it is recommended that an IVC filter be removed as soon as the risk for pulmonary embolism has decreased.

However, investigations have proven that IVC filters are not always removed when a patient’s condition has subsided. In fact, a meta-analysis of 37 studies comprised of 6,834 patients found that IVC filters were removed only a third of the time, therefore creating conditions and complications that can jeopardize a person’s health and well-being.

A report released in 2010 indicated that the FDA had received more than 900 harmful reports that involved IVC filters including device migration, embolization of device, perforation of the IVC, and filter fracture.

Fatal complications.

IVC users face many risks including the migration of these devices. The most frequent cause in IVC migration is improper surgical implantation, as well as not removing the devices when no longer necessary.

Filter migration is the term used to describe the shifting or moving of the device within the patient’s veins. In several published studies on IVC filters, there were cases where individuals experienced consequences that directly affected vital organs. Those who were most affected were those who had new retrievable filters.

As per the Journal of Invasive Cardiology, there was a case of a 54-year old man who developed ventricular tachycardia and elevated troponin because of filter migration. When medical exams were performed, medical physicians found that the IVC was in the right heart ventricle.

Physicians were forced to perform cardiopulmonary bypass surgery in order to remove the filter from its dangerous position.

In 27 other cases, it was found that newer filters made of nitinol, phynox, and elgiloy greatly increased the chances of filter migration into the right ventricle. In fact, studies have shown that filter migration into the right ventricle has noticeably increased throughout the years, and has caused life-threatening symptoms including ventricular arrhythmias, deaths, and increased rates of surgical removal.

If surgeons find that it is too difficult to remove a migrated filter, a patient may be required to have frequent monitoring or permanent follow up care.

Who should you contact?

If you or a loved one were injured by the unsafe side effects of an IVC filter, call the law offices of Hotze Runkle PLLC. Our aggressive legal team is committed to your justice. We possess the required credentials necessary for any case involving medical devices.

Hotze Runkle PLLC is here for you! Call us today at (877) 919-0830.


7 Things You Should Know About IVC Filters

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Every year, a quarter of a million inferior vena cava (IVC) filters are surgically implanted into patients who are at risk of forming blood clots, but who cannot take anticoagulant medications (blood thinners).

IVC filters are devices placed into a large vein in the abdomen area to stop blood clots, however, recent studies have indicated that IVC filters can cause serious health complications and even death.

Sadly, a vast number of patients have had to deal with these critical medical issues, and hundreds have begun seeking legal action against the device manufacturer. The claims argue that the manufacturer failed to properly warn physicians and patients about the risks, and was negligent in its representation of the device’s health benefits. There are also allegations of design flaws in the devices.

Thus far, the devices listed in the legal filings include:

  • The Bard Recovery Filter
  • The Bard G2 Filter
  • The Bard G2 Express Filter
  • The Cook Gunther Tulip Filter
  • The Cook Celect Filter

Also, please take the following into consideration:

  1. The longer an IVC filter remains implanted, the higher the risk of injury. IVC filters are not meant to stay in your body permanently and are designed to be removed. Once a patient’s blood clot risk has passed, the device should be taken out. The FDA recommends that removal take place between 1-2 months after implantation (a recent study suggest only 8.5% of IVC filters are removed).
  2. The FDA has received hundreds of reports linked to IVC filters. The FDA has been made aware of adverse effects of the IVC filters, receiving over 900 reports linked to the devices. Injuries include: device migration, filter perforations, filter fractures, and embolization.
  3. The maker of the IVC filters may have known about the potential complications. There is evidence that suggest C.R. Bard was aware of potential issues with the devices, even before the FDA approved it. However, in an effort to increase sales, the devices were still manufactured and marketed.
  4. A new study suggests that IVC filters do not provide medical benefit. It has been shown that IVC filters can actually increase the risk of deep vein thrombosis (DVT) in trauma patients. In a study that took place between 2010 and 2014, researchers found that patients were 83% more likely to develop DVT than patients without a filter.
  5. The device is linked to dozens of deaths. An NBC investigative report uncovered the fact that the IVC filters have been linked to at least 27 deaths nationally. While C.R. Bard has discontinued the Recovery series of filters, its replacement filter, the G2, has been linked to around 12 deaths.
  6. Bard may have acted illegally by misbranding and failing to report to information. In 2015, the FDA sent a warning letter to C.R. Bard for: creating a device known as the Recovery Cone Removal System which was never approved or cleared by governing body, flawed manufacturing practices, and failing to establish procedures for reviewing and evaluating complaints related to the device.
  7. The law only allows you a limited time to pursue your rights so do not hesitate to contact an attorney immediately.

The attorneys at Hotze Runkle PLLC have the experience, determination, and capability to help you deal with the manufacturers of IVC filters.

If you, or a loved one in your family, have had to deal with serious health issues as a result of having IVC filters, let the attorneys of Hotze Runkle PLLC fight for the justice you deserve.

To ensure that you receive the legal guidance your suffering necessitates, please contact us today for a free consultation on your legal options. Hotze Runkle PLLC will analyze your experiences and help you to determine if you have a qualifying case for compensation.

Contact us today at 877-919-0830