Invokana amputation lawsuit and lawyer

Invokana Amputation Lawsuit

Increased Risk of Amputation With Invokana Diabetes Medicine

Based on new data from two large clinical trials, the US Food and Drug Administration (FDA) has confirmed that the Type II diabetes medicine canagliflozin (which has brand names like Invokana, Invokamet XR, and Invokamet) comes with an increased risk of leg, toe and foot amputations.

To describe this risk, the agency added new warnings to canagliflozin drug labels, which includes a prominent “Black Box Warning”.

Studies Confirm Invokana and Invokamet Linked to Increased Risk of Amputations

invokana amputation studyThe two clinical studies that were conducted to study the long-term effects of Invokana on the heart were the CANVAS and CANVAS-R trials. The final study results were reported in 2017, concluding that the risk of amputations in patients taking the drug increased by two times.

How Common are Diabetes Amputations?

How common are invokana amputationsThe CDC – Centers for Disease Control and Prevention estimates that 23.6 million people in the United States currently have diabetes. In the past 10 years, the number of diabetic patients in the country has increased significantly from 18.2 million in 2003.

A serious concern for people with diabetes is amputations. A lot of amputations are performed on the lower extremities, particularly the feet and toes. Although it is less common, some people who have diabetes require amputations below the knee.

Nearly 67% of amputations in the US are associated with diabetes and complications that are related to it. The CDC reports that in 2010, approximately 73,000 non-traumatic amputations of the lower limbs were performed in adults aged 20 years or older who were diagnosed with diabetes.

The rate of amputation for people with diabetes is 28 times higher when compared to those who do have the disease. Amputations are performed more commonly for men than women, with a 50% higher rate of amputation for males with diabetes. Research has also found that the disease affects the non-Hispanic black population and the elderly more frequently.

Why Do People with Diabetes have a Higher Risk of Amputation?

invokana higher risk for amputationsWhen it comes to amputation, there are multiple factors that come into play. Although a large number of the issues that cause the need for an amputation involve, there are those that are related to the management of glucose in the body and unknown risks of certain medications.

Two major issues that create cause for an amputation are poor circulation and nerve damage, worsened by blood sugar that is left uncontrolled. These complications allow infections to set in without the knowledge of the diabetic, resulting in a gangrenous wound that could require an amputation at a later stage.

Risk Factors for Diabetic Amputations

People with diabetes have sensitive feet with a higher vulnerability to injuries, especially when blood glucose is not managed. All of the factors that cause amputations actually work together, and this is why it is extremely important to be aware of each one.

Diabetic neuropathy reduces sensation and makes patients unaware that they have injuries because they are unable to feel the development of wounds. On the other hand, poor circulation prevents injuries from healing properly. Knowing the risk factors for diabetic amputation plays a key role in prevention.

Diabetic Neuropathy

Diabetic neuropathy is a common complication that comes with diabetes. It is a form of nerve damage that high blood sugar causes. It results in injury to nerve fibers all over the body and leaves patients with a decrease in sensation in the lower limbs and feet.

Neuropathy may prevent people with the disease from feeling hot or cold temperatures. They might not notice a callus or cut, making them more vulnerable to infection.

There are 4 types of diabetic neuropathy: autonomic neuropathy, mononeuropathy, radiculoplexus neuropathy, and peripheral neuropathy.

Symptoms of this complication might include numbness, burning, tingling, and pain. Some people with neuropathy experience vision complications, bladder problems, digestive issues, and erectile dysfunction.

Poor Circulation

Diabetes may cause blood vessels to narrow and harden, limiting the flow of blood to the legs and feet. When blood flow is lacking, it can have an adverse effect on the body’s ability to fight infections and the speed of wound healing. Peripheral vascular and arterial diseases are some identifiable indicators of poor circulation.

Smoking also has an effect on the body’s small blood vessels. It can reduce the flow of blood throughout the limbs make it more difficult for injuries to heal. Many diabetics who need to be amputated are smokers.

Calluses, Ulcers, and Skin Changes

Changes in the skin, related to nerve damage, has an effect on the moisture and natural oils in the feet. When diabetes affects toe and foot skin, it results in dryness, which in turn makes it more likely for the skin to crack and peel. If there are changes in the foot’s natural regulatory state, it makes the patient more vulnerable to infection, injury, and amputation.

Caused by repeated irritation pressure or friction, calluses are also more common with diabetes. Complications can arise from calluses that are not trimmed or treated. They frequently occur on the bottom of the big toe or the ball of the foot.

Calluses may develop into painful open sores called ulcers. Neglecting treatment of ulcers or walking on them can lead to infections that are deeply embedded. Many of these are non-healing wounds that may result in the loss of a limb.

Invokana Amputations

invokana amputation riskThe reason for an Invokana amputation has not yet been determined or clearly understood. However, researchers confirm that the popular diabetes medication in conjunction with other risk factors makes it more likely that patients will need an amputation.

A history of prior amputation may also predispose patients who take Invokana to the need for amputation. Patients with a history of peripheral vascular disease or amputation had the highest risk of amputation, but the relative risk was similar.

Diabetes patients, regardless of a prior risk, are encouraged to discuss the potential amputation side effects of Invokana with their doctors.  

Most diabetic foot infections need some type of surgical intervention, but diabetics can actually avoid many foot problems. Taking the time to learn about and understand the risk factors, key elements of proper care and all the risks that come with medications, like Invokana, can make it possible to prevent diabetic foot ulcers and amputations.   

The most common amputations that diabetics taking Invokana suffer are toe and middle-of-the-foot amputations. The drug can also cause patients to need amputations of the leg below or above the knee. After taking Invokana, patients may need to have one or both of their limbs amputated.

Diabetics who take Invokana should be closely monitored for signs and symptoms of conditions that might make it necessary to get an amputation performed.

Amputations may be required as a result of infections or ulcers, especially those that reach the bone. It is important to keep in mind that even minor cuts or other punctures or trauma to the skin can result in life-threatening infections. In instances like these, patients may not be able to avoid an amputation.

Patients who take Invokana should inform their healthcare provider immediately if they develop new tenderness or pain, sores or ulcers, and infections in the feet or legs.

Diabetic Amputations vs. Invokana Amputations

According to the American Diabetes Association, diabetics are more likely to have a foot or leg amputated than other people. About 15% of people with diabetes develop ulcers on their foot, and roughly a quarter of those people will require an amputation.

Amputation can be caused by diabetes or the use of Invokana. When the legs and feet do not have proper circulation of blood, it can result in the need for both types of amputation. Invokana amputations begin with the body getting dehydrated because of increased urination that the drug causes. On the other hand, diabetic amputations often begin with blood sugar levels that are poorly controlled.  

What is Invokana?

invokana linked to amputationsInvokana is one of the brand names of the popular Type II diabetes medication, canagliflozin. It works to lower the levels of blood sugar in patients by blocking the re-absorption of glucose in the kidneys so that the excess sugar is eliminated from the body through urination.

The active ingredient in Invokana, canagliflozin is also one of the active ingredients in Invokamet, which is a combination product and another medication used for treating the disease.

Invokana is one of the few medications that belong to the SGLT2 Inhibitor class of antidiabetics, which includes brand name medications Jardiance and Farxiga, along with combination products Synjardy, Glyxambi, and Xigduo. Since the approval of Invokana in 2013, it has been shown to increase the risk for serious side effects, which include the following:

  • Diabetic ketoacidosis
  • Kidney disease and renal failure
  • Severe urinary tract infection (UTI)
  • Increased risk of bone fracture

In May 2016, a safety alert was issued regarding CANVAS and CANVAS-R trials’ interim results which showed the doubling of amputation risk in patients taking Invokana. The risk was confirmed in the trials’ final results, which were reported in 2017.

Based on these final results, the most serious safety alert possible, the Black Box Warning, was issued by the FDA. This warning includes information about the risk of amputation.  

Results of the CANVAS Trial

invokana amputation CANVAS Trial

Source: Medscape

The boxed warning included on Invokana labeling was an addition to the information already printed on the labeling of the drug regarding an increased risk for lactic acidosis due to metformin, one of the ingredients used in Invokana.

As mentioned earlier, the risk of amputation was identified during the large, CANVAS and CANVAS-R studies which were originally undertaken to study the long-term effects of the drug on the heart.

Janssen Pharmaceuticals and Johnson & Johnson, the parent company, had hoped to find positive cardiac results for Invokana but found an increase in the risk for amputation instead.

Patients who participated in the two clinical trials were followed for 5 years. The studies compared patients taking Invokana with those taking a placebo and found that the risk for amputation was as follows:

  • The placebo patients experienced amputation at a rate of 3/1,000 patients annually.
  • Patients taking a daily dose of 100mg Invokana experienced at a rate of 5/1,000 patients annually.
  • Patients taking a daily dose of 300mg Invokana experienced amputation at a rate of 7/1,000 patients annually.

This shows a low dose of Invokana caused an increased risk that is two-thirds higher while a higher dose resulted in more than 2 times the risk of amputation.

Amputation Risk Warnings

invokana amputation warningThe safety alert regarding the Black Box Warning issued by the FDA states that health care practitioners should consider the general health of patients and specific factors before they prescribe Invokana to patients with Type II diabetes.

Conditions like leg or foot ulcers, neuropathy, peripheral vascular disease and prior history of amputation may add to the increase in the risk of amputation due to inability to sense injury and lack of blood flow. Warnings are issued to practitioners to make sure that they monitor the foot and leg health of patients and discontinue Invokana if there are any complications.

Patients are advised to report any symptoms that affect the health of their skin or extremities, such as tenderness, sores, infection or pain. However, they should not discontinue the medication without first seeking advice from a healthcare professional.  

Other Safety Alerts

FDA invokana amputation warningsThe Black Box Warning issued by the FDA was only the most recent safety alert in a string of notifications that involve Invokana.

In March of 2013, Invokana was the first approved SGLT2 inhibitor. By mid-2015, the agency noted that it had received a large number of adverse event reports about the medication and other SGLT2 inhibitors for events involving diabetic ketoacidosis (DKA) which had required hospitalization.

In May of 2015, a safety alert about this development was issued, which was followed by labeling changes in September about bone density loss that contributed to the increase in the risk of fracture.

Another safety warning about DKA was issued in December of 2015, which included warnings about an increase in the risk of severe UTI which may contribute to kidney failure. Updates were made to labeling to include information about DKA, UTI and kidney failure.

As mentioned earlier, the first risk warning about amputation was issued in May of 2016 based on interim results of the CANVAS study.

A month later in June, more information followed to strengthen warnings about kidney injury. The most recent warning – the Black Box Warning – was issued in May of 2017 about the potential of doubled risk of amputation that comes with Invokana and Invokamet.

The Continuing Problems of Johnson & Johnson

Janssen Pharmaceuticals is a subsidiary of Johnson & Johnson, the pharmaceutical giant that has an estimated annual revenue of nearly $72 billion. Due to problems with several of their products that range from surgical products and medical devices to consumer products such as baby powder to a number of drugs that they manufacture, like Invokana, the company has faced a number of medical injury crises.

Injuries caused by Invokana are being evaluated by regulators from across the globe, including the EU where European medical regulators at the Risk Management Committee of the European Medicines Agency have requested Johnson & Johnson to provide more information regarding the amputation risk of Invokana.

Other drugs for treating diabetes, including SGLT2 inhibitors, Jardiance and Farxiga, are also under fire. However, the same warning does not come with either drug as of yet.

Numerous lawsuits involving Invokana have already been filed by patients or family members of those who have suffered serious side effects that have been caused by the drug. Invokana lawsuits have included kidney failure, bone fracture, diabetic ketoacidosis and other serious injuries.

More of these lawsuits may be expected as a result of Invokana causing the need for amputation in some patients who take the medication.

Filing an Invokana Lawsuit

What Should I Do? Invokana LawsuitThe most recent update from the United States District Court for the District of New Jersey states that trials for Invokana lawsuits are expected to begin in September 2018.  There are more than a thousand Invokana lawsuits pending. At least and at the time of writing there were 1,100 Invokana lawsuits have been filed against Janssen Pharmaceuticals.

In the complaints included in these lawsuits, plaintiffs say that they would have avoided taking Invokana had they known about the increased amputation risk ahead of time. Since proper warnings were not provided by Janssen Pharmaceuticals, consumers were not able to make an informed choice on the matter.

There have been similar legal complaints about other serious side effects of Invokana. These are related to the various warnings issued by the FDA around renal failure, ketoacidosis, serious urinary tract infections, and bone fractures.

To find out if you are eligible to file an Invokana lawsuit, the first thing you should do is contact an accomplished Invokana amputation lawyer with experience in handling cases involving dangerous drugs.

This will help the lawyer learn more about your situation. Certain factors determine whether you are eligible to participate in an Invokana class action lawsuit or to file an individual lawsuit against the manufacturer. These factors include when you began and stopped taking Invokana, the side effects that it causes, and the severity of the harm you suffered as a result of taking the drug.

If your situation meets the initial criteria for case selection, the lawyer will order, pay for, and review your medical records. Board-certified physicians will also review those records to confirm that Invokana was the cause of your condition. If this can be proven, your legal counselor will determine the option that is best suited for your individual case and they can then immediately pursue that option.

Medical Bills and Other Costs

The reason that many people file Invokana lawsuits is to attempt to obtain compensation to recover costs that are related to medical bills. These costs can include surgery, hospitalization, post-operative care, and ongoing medical needs.

On top of this, the compensation can also cover related costs such as travel expenses incurred to see a specialist, lodging near centers where patients received treatment, and expenses that insurance may not cover.

Pain and Suffering

People who have experienced a severe side effect as a result of taking Invokana claim in their lawsuits that they suffered additional pain and suffering beyond what was expected due to the drug, based on the marketing and warning labels that the manufacturer provided.

While the specific suffering might differ from one patient to another – amputation, ketoacidosis, kidney disease, etc. – the common link between them is that those conditions were exacerbated or caused by Invokana.

In addition to physical pain and suffering that Invokana caused, many patients who took the drug have also suffered mentally. For instance, a number of psychological effects can result from amputation, including phantom limb syndrome, post-traumatic stress disorder (PTSD), and depression. All of these mental health conditions would not have been experienced by patients had they not taken Invokana.

In most cases, Invokana amputation lawsuits include claims to recover these costs that victims of injuries caused by the medication would not have needed to pay otherwise.

For those who passed away due to complications caused by Invokana, their families may ask for compensation to cover funeral and burial costs as well as lost income that their loved one might have otherwise earned.

invokana amputation lawyer

Obtain the Help of a Fantastic Invokana Lawyer

If you or a loved one has received an amputation or suffered another serious complication or side effect as a result of taking Invokana, you may be eligible to file a lawsuit against the drug manufacturer. Discussing your case with a prudent and motivated Invokana lawyer is the best way to learn about your legal rights and gain more information specific to your case.

It is important to have an Invokana lawyer to help you as you will need help in understanding the strength of your case what to expect if you file an Invokana lawsuit. Fighting back against major drug companies like Johnson & Johnson will require the knowledge, skill, and resources that only an experienced legal pro has.

When you have someone who knows how to fight back against the corporation’s highly trained and well-paid lawyers, you get the best chance of receiving the compensation you deserve for complications you experienced as a result of taking Invokana.  

Senior man suffering from chest pain in living room at home

IVC Filter Complications Lawsuit

Inferior vena cava also known as IVC filters were approved by the US Food and Drug Administration in 1979 and are now available as retrievable or permanent implants – the retrievable type being an option for short-term use.

The FDA received close to 1,000 complaints from 2005 to 2010 about adverse events associated with IVC filter removal complications and the failure of the newer retrievable filters.

There was no report from the FDA about the remaining 34.8% of adverse event reports, but a warning was issued regarding an increased risk of IVC deep venous thrombosis (DVT). In lieu of these reports, the agency set about advising health care providers to remove the retrievable IVC filters once the patient’s condition improved and there was no longer any threat of pulmonary embolism.

The unfortunate part is that a large number of the worst complications occurred when the retrievable filters were removed. Few were caused by the presence of the device in the body or the implantation procedure.

How Do IVC Filters Work?

An inferior vena cava filter is a small, metal device that is designed in such a way so as to prevent a blood clot from making its way to the lungs and resulting in a pulmonary embolism. A pulmonary embolism is a blockage in an artery that transports blood to the lungs from the heart – this blockage can sometimes be fatal.

The cage-like device is surgically implanted into the inferior vena cava, the largest vein in the body. IVC filters are made so they can trap clots, but the flip side is that these sophisticated devices can potentially move in the body and cause IVC filter complications that may have devastating consequences.

Types of IVC Filters

C.R. Bard and Cook Medical are two of the major manufacturers of IVC filters. The most popular IVC filter brands include:

  • The Bard G2 filter
  • The Bard G2 Express filter
  • The Bard Recovery filter
  • The Cook Gunther Tulip filter
  • The Cook Celect filter
  • The Boston Scientific Greenfield filter

As mentioned earlier, there are two types of IVC filters: permanent and retrievable (optional). Although they are intended for short-term use, retrievable filters provide the option for long-term use or removal when a risk for pulmonary embolism is no longer present. On the other hand, permanent IVC filters are designed only for long-term use.

It is important to note that IVC filter lawsuits are only being filed against the manufacturers of retrievable filters.

According to a study from 2014 that was published in the Journal of Vascular Surgery, retrievable IVC filters left in place were linked to significantly higher rates of complications than permanent filters. The authors of the study identified 383 patients with implanted retrievable IVC filters and compared them with patients who had permanent filters. It was found that blood clot-related or thrombotic and device-related were common among patients with retrievable filters.

Uses of IVC Filters

Blood clots that develop in the upper and lower extremities and deep inside the pelvis are referred to as deep vein thrombosis or DVTs.

While they are not typically life-threatening, DVTs can lead to death when they travel to the lungs and produce clots that block the normal flow of blood in the lungs, also known as pulmonary embolisms.

About 300,000 deaths occur each year due to these embolisms. It ranks third among the most common causes of death in hospital patients.

People who had recurrent DVTs while they were on blood-thinning (anticoagulation) medication and/or people who are unable to consume or tolerate these medications due to bleeding or an adverse reaction make good candidates for IVC filters.

Doctors may also recommend these medical devices in patients who undergo surgery because of an elevated risk of blood clots or suffer serious trauma.

Cases in which the use of IVC filters may be recommended include the following:

  • Car accidents
  • Stabbing or gunshot injuries
  • Emergency or voluntary surgeries
  • Dialysis treatment
  • Cancer diagnosis or treatment
  • Spinal cord injury
  • Serious falls
  • Immobile patients
  • Patients who just had a baby

Complications Caused by IVC Filters

IVC filters can in certain cases float away from their surgically-positioned site thus rendering them ineffective. In some cases, the device punctures a vein, resulting in bleeding and other complications.
The filters can break into pieces, which can then travel through the blood and lodge in the heart or other organs. Retrievable filters, in particular, are linked to a number of potential risks, such as failing to stop blood clots from bypassing the device and damaging veins.

Typically, complications caused by IVC filters fall into three categories: procedural, retrieval and delayed.

Procedural IVC filter complications occur when the filter is inserted. These complications include:

  • Bruising and/or bleeding in the access site
  • Blood vessel puncture
  • Malposition and/or incorrect placement of filter
  • Deployment of defective filter

Retrieval complications occur when the filter is removed and include the following:

  • Perforation of blood vessels
  • Large clots in the filter that prevent device removal
  • Scars in the vein that prevent device removal
  • Difficult retrieval resulting in long surgery times

Delayed complications occur after the IVC filter is implanted in the patient’s body and include the following:

  • Migrating to other parts of the heart, vena cava or even other organs
  • Breakage or fracture of the filter
  • Deep vein thrombosis
  • Perforated organs
  • Blockage that results in swelling in the legs
  • Device infection
  • Detachment of device components or embolization

Complications of IVC Filter Placement

To place an IVC filter, a doctor, in most cases, will use a catheter inserted through the skin into a large vein in the thigh or the neck and thread it to the inferior vena cava in the abdomen.

The doctor threads the filter through the catheter into the vein with the help of image guidance, including ultrasound, and x-ray and a contrast agent, or a substance that is introduced into the patient’s body so that the medical professionals are able to see.

This is a procedure that is referred to as percutaneous. It has been reported that the rate of complications from this procedure range from 4% to 11%.

Short-Term Complications from IVC Filter Placement

Other possible complications that can arise from the placement of IVC filters include the guide wire penetrating the vein, kidney dysfunction resulting from the contrast agent, blood clotting at the insertion site, bleeding or infection of the insertion site and a condition called an arteriovenous fistula (AVF), a rare complication that involves an abnormal connection between a vein and an artery. 0.02% of this complication is reported.

Short-term complications related to the procedure can include the following:

  • Irregular or abnormal heartbeat
  • Reaction to the contrast agent
  • Pneumothorax – a collapsed lung resulting from air leaking into the space between the chest wall and the lung
  • Air embolization – which is a condition wherein air bubbles block a blood vessel
  • Hemothorax – a condition wherein blood pools up in the space between the lung and chest wall

Pain Caused by Defective IVC Filters

When patients experience pain with an IVC filter, it is often related to complications of the filter that may be malfunctioning or defective. Some IVC filter complications that can lead to severe pain include a blocked filter, IVC perforation, or embolization.

IVC filters can also perforate or become embedded in the wall of the IVC. But because there are no nerve endings in blood vessels, it is unlikely that patients will experience any pain that is linked to complications that directly affect the vein and they will consequently not be aware that there is a problem.

However, once the vessel has been pierced all the way through by an IVC filter, or if it breaks apart as it moves through the bloodstream, it can have an effect on other parts of the body causing pain.
The pain that often is caused due to IVC complications can affect the heart, back, abdomen or even the legs.

History of Safety Concerns about IVC Filters

The FDA issued its first safety communication about IVC filters in the year 2010. As mentioned earlier, the agency recommended removing the device once protection from pulmonary embolism was not required anymore.

The safety advisement and recommendation from the agency came after it received and reviewed over 900 reports of adverse events related to the anticoagulation device over a period of 5 years.
Adverse events that were reported included embolization, device migration, filter fractures and perforation of the IVC and organs. In most cases, these events occurred long after the risk for pulmonary embolism in the patient had subsided, yet the IVC filter was not removed from the body.
Updated Safety Communication by the FDA

The FDA issued an updated safety communication in 2014 regarding IVC filter use and removal. There were no new safety concerns in the notice.

Instead, the agency chose to report that after the risk of contracting pulmonary embolism in patients has passed, the IVC filter can be removed. The filter according to the agency’s updated safety communication could be removed between 29 and 54 days after implantation.

The federal agency developed a mathematical model using data that was publicly available from medical literature. This model suggested that the risk of having an IVC filter begins to outweigh its benefits when it is no longer necessary to prevent pulmonary embolisms.

The FDA, concluded that IVC filter complications could be certainly mitigated if doctors promptly removed the anticoagulant device after the risk for pulmonary embolism had abated.

Warning Letter

The FDA issued a warning letter to the manufacturer of the Recovery Cone Removal System and several IVC filters, including CR Bard in 2015. The agency noted that the removal system was never given clearance and therefore, there was presumably no method that was approved for the removal of IVC filters manufactured by the company.

The regulatory agency also admonished Bard for failing to follow good manufacturing practices in the processes of manufacturing, packaging and storing its IVC filters, and for failing to establish and maintain appropriate procedures to receive, evaluate and review complaints regarding its anticoagulant devices.

The FDA further noted that CR Bard failed to report information that it received about defects linked with its IVC filters that could possibly lead to injury or death.

Complications Claimed in IVC Filter Lawsuits

People who filed IVC filter lawsuits against manufacturers claim that the devices implanted in their veins moved or broke. These problems can result in serious complications. People can file lawsuits for IVC filter complications such as:

  • Blood clots
  • Migration of the device
  • Fracture of the filter
  • Organ perforation
  • Organ damage
  • Impossible filter removal

It is also important to note that many IVC filter lawyers are accepting cases where no injury or complication has occurred.  In other words, if you have an implanted IVC filter, you may be entitled to compensation by filing an IVC filter lawsuit (regardless of injury).

IVC filters are cone-like devices with spindly legs that deploy inside of the inferior vena cava. In some instances, the legs can puncture the veins. Or the filter can perforate or break. If this occurs, the entire filter or parts of it can travel through the body. That can result in damage to the heart, lung or other organs.

FDA Reports and Actions

Between 2005 and 2010, the US Food and Drug Administration (FDA) received 921 reports of adverse events involving IVC filters. Roughly 328 of those reports involved device migration, 70 involved perforation of the device, 146 involved embolizations, and 56 involved fracture of the filter.

Some of the reported events caused patients to experience adverse clinical outcomes. The FDA concluded that the adverse events that were reported could have been caused by a retrievable filter that remained in the patient’s body after the risk for pulmonary embolism had come down.

The agency recommended the removal of retrievable filters within 54 days after they were implanted if the risk has diminished.

The FDA has also required additional information from studies to be collected for IVC filters that are currently marketed in the United States. According to the agency, the studies address unanswered safety questions for permanent as well as retrievable IVC filters.

Manufacturers were given two options for data collection: post-market surveillance or the PRESERVE study. PRESERVE stands for Predicting the Safety and Effectiveness of Inferior Vena Cava Filters.
It is an independent national clinical study that will examine IVC filter use in the prevention of pulmonary embolism. 522 studies will be involved in post-market surveillance.

According to a study in 2016 in Seminars in Interventional Radiology, the FDA said that the data that is collected from the 522 studies and PRESERVE study will help the agency, the manufacturers of the IVC filters and health care professionals make an assessment of the use and safety profile of the filters, understanding evolving patterns in clinical IVC filter use, with the goal of ultimately improving utilization of IVC filters and patient care.

Recalls of IVC Filters

Between 2005 and 2010, manufacturers issued 6 major recalls of IVC filters. The recalls had an effect on over 81,000 units, and the majority was for issues with packaging and labeling.

Since 2015, there have been no major recalls for IVC filters. Thousands of people have reported experiencing complications caused by these medical devices. However, manufacturers have not recalled devices that are known to be most problematic.

An NBC News investigation in 2015 connected Bard Recovery and G2 IVC filters to the death of 39 people. Neither device was recalled by the company. They were replaced with similar models instead.
Cook Medical IVC filters have also come under fire for causing injuries and deaths. Hundreds of reports have been received by the FDA on Gunther Tulip and Cook Celect problems. However, the company never issued recalls for either of these devices.

Studies on IVC Filters

Studies have confirmed that retrievable IVC filters come with problems. The failure rate of the filter was looked at in a 2013 study that was printed in JAMA – Journal of American Medical Association, a group of researchers discovered that only 58 out of 679 retrievable IVC filters were actually removed by doctors.

When the filters, remained in patients longer than medically necessary, 25 patients were reported to have suffered pulmonary embolisms, 18.3% of filter removal attempts failed, and 7.8% of patients had venous thrombotic complications.

Failure Rates of Filters

Introduced in 2003, the Recovery filter was the first-generation product manufactured by C.R. Bard. The Bard G2, a second-generation device, was introduced in 2005 to replace the Recovery. However, before Bard introduced the replacement, the FDA received 300 reports of adverse events that are associated with the device.

One study had results showing that about 25% of the Recovery IVC filters failed, causing the device to break apart or fracture. While the study did not provide a reason, one patient died at home. An NBC News investigation connected the device to at least 27 fatalities.

The Bard G2 had a failure rate of 12% and remained for a shorter period of time in the market than its predecessor.

When the G2 came into the market in 2005, Bard stopped the sale of the Recovery. In 2008, the G2 Express, the G2’s successor, entered the market. One study found that all of the devices manufactured by Bard experienced a combined fracture rate of 12%.

In another study, it was found that both of the filters manufactured by Cook Medical, the Celect and the Gunther Tulip, had histories of perforating the vena cava wall of patients. In most cases, the perforation occurred within 71 days from being implanted, and the filters migrated out of place in 40% of patients.

“Significant Decline” Shown in Use of IVC Filters

A study conducted in 2017 found that IVC filter use experienced a “significant decline” after the safety warning issued by the FDA in 2010.

Researchers at St. Louis’ Washington University School of Medicine examined more than 1 million patient records that covered a period of 10 years. They saw a rise of over 22% in the use of IVC filters between 2005 and 2010. However, there was a dramatic drop in the use of these devices after the FDA advisory, going down by over 25% by 2014.

At their peak in 2010, nearly 130,000 IVC filters were implanted in patients. The number had fallen to about 96,000 by 2014.

Accusations Against Manufacturers of IVC Filters

In IVC filter lawsuits, plaintiffs claim that CR Bard and Cook Medical manufactured devices that were defective, resulting in their injuries.

They also claim that the manufacturers knew or should have known that their products were dangerous. According to the lawsuits, the companies failed to adequately warn health care providers and patients about the dangers associated with IVC filters.

The allegations in IVC filter lawsuits include:

  • Defective design and manufacturing of the device
  • Misrepresentation in marketing
  • Failure to provide warnings about the dangers of the device

Filing an IVC Filter Lawsuit

If you want compensation for an injury caused by an IVC filter, you should file a lawsuit. However, it is important to bear in mind that cases that involve medical devices are complex.

Therefore, you should seek the help of an IVC filter lawyer as they usually have experience in handling complicated lawsuits involving medical devices. IVC filter lawsuits involve complicated medical, legal and engineering issues. With a medical device lawyer, you have a professional with acumen in these areas.

If you have suffered injury due to an IVC filter, you should consult a medical device lawyer who will review your case and determine if you are eligible to sue the manufacturer of the device. Keep in mind that your fight against major companies like CR Bard or Cook will be long and arduous.

Your legal pro will protect your rights and make sure that you are treated fairly throughout the legal process. Because the corporation will have a team of highly trained and experienced lawyers to defend them, it is crucial that you find a legal counselor who will fight just as passionately for you.

If you or a loved one has experienced a serious complication after placement of an IVC filter, you should immediately seek the help of a skilled and judicious medical device lawyer. Your attorney will determine if you should file an individual lawsuit against the manufacturer or join a class action lawsuit depending on the facts of your case.

Once you take the best legal course of action for your case, you can begin the process of suing the manufacturer of the IVC filter and receive compensation for your injury and other damages resulting from the IVC complication.

Roundup weed killer lawsuit

Roundup Cancer Lawsuit

Filing a Roundup Lawsuit – A Complete Guide

One of the worst nightmares that every homeowner has is weeds. Everyone wants a well-maintained lawn, but once weeds start taking over, it can seem like nothing you do can keep those persistent irritants from growing back.

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Depuy Synthes Elbow Lawsuit

Depuy Synthes Elbow Recall Lawsuit

What You Need to Know About Depuy Synthes Elbow Replacement – Depuy Synthes, a subsidiary of Johnson & Johnson, developed the Radial Head Prosthesis Device, which is a medically used elbow replacement prosthetic device. This is an elbow joint prosthesis made of two pieces that are used for primary as well as revision joint of the radial head of the elbow.

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Abilify Lawsuit

Thousands of patients have experienced uncontrollable gambling, sexual behavior, eating and shopping habits while prescribed to Abilify. This type of compulsive behavior often causes great emotional distress as well as alienation from family and friends. For this reason, patients across America have begun to file lawsuits against the drug’s manufacturer, claiming they were not properly warned of Abilify’s devastating side effects.

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Avastin Lawsuit

Avastin – generic name Bevacizumab – is classified as an “anti-angiogenesis” and “monoclonal antibody” drug. It is used in the treatment of:

  • Metastatic rectal or colon cancer – the drug is used as part of a combination chemotherapy regimen
  • Non- small cell, non-squamous lung cancer
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  • Metastatic breast cancer – the drug is used as part of a combination chemotherapy regimen
  • Glioblastoma (GBM)

The drug works by blocking vascular endothelial growth factor (VEGF) – a certain type of protein – which thereby decreases the blood supply to the tumor and slows the growth of the tumor.

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Zostavax Lawsuit

Zostavax is a single-shot vaccine for adults who are aged 50 or older that helps in boosting the immune system against shingles (herpes zoster). However, once you have the condition, the drug cannot be used to treat it or the nerve pain that may follow.

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Gadolinium Toxicity & Deposition Disease Lawsuit

One of the 17 rare-earth elements, gadolinium (Gd) is part of the “lanthanide” series of metals. A large percentage of rare-earth metals have a toxic effect on human beings.

Also known as Magnetic Resonance Imaging, or MRI, dye, gadolinium has paramagnetic properties, meaning that there is a slight increase in its temperature when it moves through a magnetic field, like an MRI. It is these properties that make it useful in enhancing the quality of images in MRI scans.

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