Inferior vena cava (IVC) filters are designed to prevent blood clots in patients who cannot use blood thinners. While they have enjoyed widespread use for some years, there is a good deal of controversy that surrounds them as well.
To date, there have been thousand of reports of issues arising from the use and removal of these devices. IVC filters are susceptible to migration within the body and the procedure to remove even the most modern versions can still be very dangerous and difficult to perform.
The attorneys at Hotze Runkle PLLC take great pride in staying current on news related to the various legal services we provide so that our clients can be well-informed as well.
Recent information shows that the use of IVC filters is a medical topic that is under considerable scrutiny, and because of this, professionals in the medical field are beginning to reexamine the use of the devices and the frequency in which they are implanted in patients.
Decreases in Use
One encouraging sign regarding the potential health and safety hazards associated with IVC filters is that there continues to be a decline in their use. This drop in the number of IVC filters in use began in 2010 shortly after the FDA issued a safety alert about devices that had been implanted for an extended period of time.
This overall decrease, however, has not been uniform across the country. The Northeastern U.S. has seen the bulk of the reduction, due in part to a medical environment that sees more disputes find their way into the courts. Western states have also seen decreases, but the legal atmosphere of their medical world does not have such a contentious streak.
Southern states have not experienced the same cutbacks in IVC use, largely due to tort reforms. These changes have made it harder for plaintiffs in these cases, not only to win settlements but the size of the settlements has been capped as well.
Regardless of what part of the country you find yourself in, there is likely to be a facility specializing in the removal of IVC filters. As the use of IVC filters began to decline, the number of places a patient could go to have one taken out rose greatly.
Instances of Pulmonary Embolism (PE)
Another factor that may contribute to the decline of IVC filters is that new studies are calling into question the effectiveness the devices have had in reducing the rate of PE. One particular study, published in JAMA Surgery, documents how the sharp decline in IVC use in trauma has not resulted in a rise in PE rates.
This relationship calls into question how useful these devices are in helping prevent blood clots. The possibility that they do not have much influence over the number of PE cases is something that has become hard to ignore for many physicians across the country.
While the authors of the study do not advocate the complete discontinuation of IVC filter use, they do acknowledge that there is still research to be done into their implementation.
Finding the safest ways and situations to employ IVC filters is still something that eludes even the most inquisitive and well-intentioned medical minds, which is probably as telling as recommending they not be used.
There continue to be many positive signs regarding the removal of IVC filters from medical use.
Future patients deserve to be treated with alternatives that do not come with as many safety questions.
If you or your family are seeking help with IVC filter litigation, the attorneys at Hotze Runkle PLLC are here to find the solutions to your problems and get you the justice you’ve been searching for.
Unfortunately, there are still many in need of legal aid because of the medical and health complications they have faced due to the use of an IVC filter.
The attorneys at Hotze Runkle PLLC are committed to helping those have been harmed by IVC filters.
If you or a loved one has suffered physical, emotional, and financial complications, or even death as a result of an IVC filter, Hotze Runkle PLLC is here to help.
Contact us today at (877) 919-0830.
Please be aware that there is a statute of limitations which bars claims not brought within an allotted time period after the injury occurred. Please contact us today for a free case evaluation to review your legal options and ensure proper legal guidance in your time of need.
Inferior Vena Cava (IVC) filters are small, cage-like devices implanted in the IVC vein of patients who are at risk of bloods clots, but cannot use anticoagulants (blood thinners). The devices are designed to stop a rising blood clot before it reaches the heart or lungs of a patient.
Unfortunately, IVC filters have gained a high level of notoriety, as the FDA has received more than 1,000 adverse event reports involving the metal devices. There have been a substantial number of patient injuries and deaths from IVC filters malfunctioning within the patient’s body.
Alarmingly, reports suggest that a leading manufacturer of IVC filters was aware of the potential complications, yet still marketed and sold the devices.
Severe complications include:
- Filter fracture
- IVC perforation
- Damage to vital organs (i.e. lungs and heart)
- Heart blockage
- Death
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 deserve justice. Let our legal representatives serve your needs.
Potential Symptoms of IVC Malfunctioning
If you are the recipient of an IVC filter and have been experiencing pain in various regions of your body, the following symptoms may suggest that the filter is malfunctioning or has been clogged with a blood clot.
Abdominal or Back Pain
The potential symptoms of a malfunctioning IVC filter vary from patient to patient with some cases having asymptomatic complications and others undergoing heart rhythm problems.<
One of the most commonly occurring signs of a IVC filter migration is abdominal and back pain. This can occur as a result of the IVC traveling throughout your blood vessels and lodging itself in an organ or other vein.
If the pain correlates with specific bodily movement, then the patient should visit a doctor and get examined to ensure that the filter has not moved from its intended location.
Pain in Lower Extremities
IVC filters help to reduce the risks associated with deep vein thrombosis (DVT) and are intended to prevent clots in the legs and pelvis from traveling up to the lungs and causing pulmonary embolism.
Because of this, patients may interpret pain in the legs as an issue of their DVT, but extreme pain should not rule out filter migration or perforation.
Furthermore, painfully swollen legs may show that the filter has become clogged.
Patients should visit their primary care provider if the issues continue for some time.
Symptoms in the Heart Area
If the filter has fractured and one of its struts has traveled into the heart, symptoms patients should watch for to include:
- Chest pain
- Neck pain
- Confusion
- Lightheadedness
- Nausea
- Shortness of breath
- Abnormally rapid heart rate
If the IVC filter remains embedded in the heart, then the following severe conditions can arise:
- Cardiac tamponade
- Hole in the heart
- Heart rhythm problems
- Stroke
- Hemorrhaging
- Internal bleeding
If the IVC filter has caused severe damage to the heart, then open heart surgery may be required to remedy the issue.
Asymptomatic Concerns
In many cases, the migration of an IVC filter may not be accompanied by any symptoms. As blood vessels to have any nerve endings within them, internal injuries may be asymptomatic—meaning producing no sign or symptoms.
These scenarios can be just as dangerous as patients may not even recognize they have a problem until receiving an x-ray or CT scan.
A minor movement by a IVC filter can lead to slight tears in major veins that can continue to grow over time until major issues arise and emergency invasive surgery is required.
Dealing with pain and medical complications as a result of an IVC filter? Let Hotze Runkle PLLC fight for you.
The attorneys at Hotze Runkle PLLC are committed to helping those have been harmed by IVC filters.
If you or a loved one has suffered physical, emotional, and financial complications, or even death as a result of an IVC filter, Hotze Runkle PLLC is here to help.
Contact us today at (877) 919-0830.
There is a statute of limitations which bars claims not brought within an allotted time period after the injury occurred. Please contact us for a free consultation to review your legal options and ensure proper legal guidance in your time of need. Hotze Runkle PLLC will review your experiences and determine if your case qualifies for compensation.
The removal of inferior vena cava (IVC) Filters has been a topic of great distress for doctors who are now attempting to remove the implants and for the patients who have undergone the procedure with hopes of it being temporary. IVC Filters are spider-like medical devices that were designed as a solution for those who cannot use blood thinning medications but who are at risk of a blood clot. The inferior vena cava is the large vein that supplies deoxygenated blood from the lower half of the body to the heart. Reports involving severe and disabling complications, including incidences in which the device migrated, titled, or became fractures and traveled through the body, have shed light on the dangers of IVC filters.
Most of these problems have been linked to the retrievable IVC Filters, or the devices designed to be removed after the risk of blood clot or pulmonary embolism has passed. Some of these removable IVC Filters have made the retrieval process difficult for doctors and their patients.
Identified Risks of Retrieving IVC Filters
Attempts to removal the IVC Filter can result in life-threatening health risks, such as:
- Damage to the vena cava
- Damage to internal organs
- Migration of IVC filter pieces to the heart or lungs
- Loss of the filter in the body
- Source of a new clot
The benefits of retrievable IVC Filters over permanent filters has been touted by manufacturers, but the very design of these filters may make them difficult to remove. In 2014, the FDA released a safety communication urging doctors to remove retrievable IVC Filters within two months after the risk of pulmonary embolism cleared. Doctors were finding that IVC Filters were too dangerous to attempt a removal or the filters simply could not be found.
In cases where individuals were told they could not have their IVC Filter removed due to close proximity to vital organs or arteries, these individuals had to start a life-long blood thinner regimen. They were also made aware that the device would pose a continuing threat as it could dislodge at any time and cause severe injury or death.
When a doctor is unable to successfully retrieve a filter via routine attempts there are four options available, all of which pose significant safety risks for the patient. The curved catheter technique, loop-and-snare technique, balloon-assisted technique, and forceps technique are all options to remove the IVC Filter. However, these pose risk of massive internal bleeding, migration of broken filters to the heart, and sudden death.
In July 2015, JAMA Internal Medicine published a journal which revealed data from a single medical center about IVC Filter removal. Of 648 procedures conducted, 14.7% of the cases required advanced techniques after routine attempts to retrieve the device failed. In that same year, the Journal of Vascular Surgery, another medical journal, published a study that noted in some cases of IVC Filter retrievable, the device simply could not be removed because it was moved from its original position.
IVC Filter Retrieval Complications and Complaints
Yannis B, an implant recipient from Athens, Greece had his Option™ ELITE Retrievable IVC Filter placed in February of 2016 in Massachusetts. The surgery took place prior to his leg amputation as a prevention against blood clot complications. Just four months later, Yannis returned to his doctor to have the filter removed. His doctor found the device to be tilted with the retrieval hook embedded in the wall of his IVC. The doctor was unable to remove the filter from its delicate and dangerous position. Yannis was able to have the filter removed after consulting with another doctor in January of 2017. The patient took legal action against Rex Medical for selling a defectively-designed medical device. Not only was the company accused of selling defective products, they were found to be negligent of warning about possible side effects. Many doctors have come forth with complaints about the challenges of removing IVC filters and finding that the devices tilt or become embedded in veins or vital organs.
Susan Karnstedt received a permanent Greenfield IVC filter in 1992 due to a history of blood clots. Over the years, she began to feel intermittent pain in her abdomen. In her case, the legs of the filter eroded through the IVC and punctured her intestines. These types of complications are believed to increase the longer the implant remains in place. After years of pain and unexpected medical results, Karnstedt sought out medical experts at Stanford Hospital. It was interventional radiologist William Kuo, MD at the hospital who discovered a creative way of safely removing the permanent device. After a non-invasive laser procedure, Karnstedt was IVC Filter-free. This may not be the case for many others who lack access to these specialists or who have already suffered the detrimental effects of IVC filters.
Hotze Runkle PLLC Takes Action Against IVC Filters
We are committed to helping those have been harmed by others find the justice they deserve. Don’t hesitate to reach out. If you or a loved one has suffered physical, emotional, and financial complications due to retrieval of an IVC Filter, Hotze Runkle PLLC is here are to help. Contact us today at (877) 919-0830.
There is a statute of limitations which bars claims not brought within an allotted time period after the injury occurred. Please contact us for a free consultation to review your legal options and ensure proper legal guidance in your time of need. Hotze Runkle PLLC will review your experiences and determine if your case qualifies for compensation.
A eye-opening study conducted by the Institute on Domestic Violence and Sexual Assault (IDVSA) at the University of Texas at Austin School of Social Work, and released in late 2016, revealed a startling discovery—Texas had more than 300,000 cases of human trafficking victims, including almost 79,000 minor and youth victims, and over 230,000 adult victims of labor trafficking.
Human trafficking is generally defined as a person being deceived or physically, emotionally, or psychologically coerced into situations of prostitution, forced labor, or domestic value. The United States Department of State considers human trafficking to be a form of modern-day slavery and punishes perpetrators severely; in Texas a convicted offender can receive a sentence of five years to life, substantial fines, restitution to victims, and possible asset forfeiture.
Texas statutes prohibit a number of activities related to the trafficking of humans including: recruiting, transporting, enticing, and providing.
Understanding the Problem
One of the biggest problems of understanding the complications of human trafficking has been to adequately track data. Most databases are only able to provide information on identified victims, which only helps to offer slight insight into the greater problem.
To better address the dilemma of human trafficking, especially in the state of Texas, which is a hub for human trafficking in the nation, the initiative known as the Statewide Human Trafficking Mapping Project of Texas was developed. Various agencies including IDVSA, the Bureau of Business Research at IC2 Institute at UT, and Allies Against Slavery, joined together to better understand the pervasiveness of human traffickings and its socioeconomic impact on the state.
With funding provided by the Criminal Justice Division at the Texas Office of the Governor, researchers were able to analyze numerous databases, work with social service agencies that assist victims, and develop other methods to track human trafficking cases more effectively.
While the authors of the study did note that their estimates were conservative, they hoped that their findings would still be able to offer some support in helping law enforcement agencies better deal with such a devastating and complex crime.
An Unfortunate Reality
The IDVSA research exposed some dismal benchmarks for human trafficking in the state of Texas including:
- An estimated 313,000 victims of human trafficking reside in Texas
- Children and young adults who are homeless or in foster care have the highest risk of falling victim to human traffickers
- The largest number of victims in labor trafficking were found in construction, cleaning services, and restaurant kitchen work
- $600 million is exploited from victims of labor trafficking in Texas
- An estimated $6.5 billion is spent on the lifetime costs of care to victims and survivors of minor and youth trafficking in Texas
Bruce Kellison, Director of the Bureau of Business Research stated, “The economic and social costs of human trafficking in Texas emphasize the importance of preventative solutions and help inform how to prioritize resources to support those who have experienced exploitation.”
When Tragedy Strikes
One of the most recent landmark human trafficking cases in Texas includes a Houston motel that has been accused of knowingly accommodating human traffickers and their victims, and which now faces a civil lawsuit filed by the victim’s family including two younger daughters. The lawsuit against Plainfield Inn, located in Southwest Houston, will be the first of its kind in Texas.
KHOU 11 News reported that the lawsuit claims the owners of the hotel were aware of prostitution, human trafficking, and other criminal activities occurring on their property, yet willingly continued to rent rooms to known criminals. The lawsuit also states that Houston Police responded to over 400 calls in just a two-year period at the Plainfield Inn for numerous crimes.
The news station confirmed that the motel has been sued multiple times by the city and state in an attempt to “clean it up.”
To better develop a case against the defendants, investigators will be able to utilize hotel records, which provide evidence of which rooms were rented out to human trafficking criminals and their victims. Phone records will also help to link traffickers to their victims and to confirm the timeline of events.
If you or a loved one fallen victim to human trafficking, contact the law offices of Hotze Runkle PLLC toll-free today at 877-919-0830. Our attorneys can help you find the justice you deserve.
Concern continues to grow in the medical community as numerous studies have emerged to suggest that IVC filters are overused, ineffective, and place unnecessary risks to the health of patients who have been fitted with the devices. The FDA has received 100’s of adverse event reports dealing with complication caused by IVC filters and even sent a warning letter to IVC filter manufacturer C.R. Bard in 2015 in reference to inspections completed at two of the company’s facilities.
As of mid-January 2017, there were nearly 1,400 lawsuits consolidated for pretrial proceedings against Bard and almost another 1,400 lawsuits consolidated against Cook Medical—and the storm appears to be far from over.
The devices emerged as a seemingly safe alternative to prevent pulmonary embolism in cases where patients could not take an anticoagulant (blood thinning medication). However, IVC filters have the potential to dislodge and migrate throughout in the patient’s body, perforating veins and embedding themselves in the heart or lungs. Patients suffer severely, and in some cases, the migration of the device has caused death.
A study published in the January 2017 edition of JAMA Surgery found that the devices did not improve mortality rates in trauma patients, thus suggesting that not all who would receive the filters actually need them. In fact, the unnecessary implantation of the devices often leads to more issues rather than providing any meaningful benefits.
The study was conducted by the trauma center at Boston University School of Medicine and tracked patients who had received an IVC filter between the period of 2003 through 2013. Studying trauma patients provided researchers an opportunity to gauge the effectiveness of IVC filters in a population that was at a high risk of developing blood clots but who could not take blood thinners because of their severe situations.
Researchers compared 451 trauma patients who had received IVC filters to over 1,300 controls who did not have the devices. Astonishingly, the study found that in patients who survived longer than 24 hours, the use of an IVC filter did not improve mortality rates in comparison to those without one. Simply put, the use of IVC filter did not improve survival rates.
Researchers followed up at 6 months and 1-year post-discharge and found no difference between those with and without IVC filters.
Another troubling statistic that was identified during the study was the low retrieval rate of temporary IVC filters in trauma patients. Researchers found that only 8% of patients with IVC filters had them removed.
This is a major concern as medical professionals typically suggest that the IVC filters be removed two to three months after implantation. The FDA has an even shorter window of removal at between 29 to 54 days. Both assume the risk of a blood clot has passed.
Retrieval of the device is essential to the physical well-being of the patient. In May 2014, the FDA issued a Safety Communication that noted the increased chance of IVC filter complications when the devices were left unnecessarily longer that needed.
While the 8% retrieval rate was substantially lower than national numbers, studies show that overall retrieval rates stand at a terrible 30% for all patients (trauma and traditional).
While the devices are designed to improve survival rates from pulmonary embolism, the reality is that low retrieval rates place them at even greater risk of other serious health complications.
Adding to these issues is that trauma patients may not even realize that they have had an IVC filter implanted during surgery and follow-up appointments are hardly practiced or required by law. Furthermore, the doctors who recommend IVC filters may not even be the same who do the implantations, making it much more difficult for patients to understand who is responsible for the removal of the devices.
Dealing with pain and medical complications as a result of an IVC filter? Hotze Runkle PLLC will fight for you.
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 deserve 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, has suffered physical, emotional, and financial injury, or even death, as a result of an IVC filter, contact us today at (877) 919-0830.
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.
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.