IVC Filter Lawsuit
IVC Filter Placement & The Lawsuit Against It
The inferior vena cava (IVC) is one of the largest and most important veins in the body. It’s job is to carry away de-oxygenated blood from lower parts of the body into the right atrium of the heart. From there, that blood is then pumped into the lungs where oxygen is reintroduced to the blood cells.
Problems with the IVC filter placement can become extremely debilitating and even life threatening. Blockage is one of the more common problems and is referred to as a pulmonary embolism. These embolisms usually happen when a blood clot forms in the leg and is then pulled upwards by theinferior vena cava where it becomes lodged in the vein and can cause severe health problems.
Options For Removing A Clot
An embolisms reduces blood flow to the lungs while increasing pressure on the heart. Treating a blood clot can be difficult as well. Thrombolysis is a pharmacological breakdown of a clot and usually the first option recommended by doctors, but isn’t guaranteed to get the job done.
Thrombolysis works by prescribing drugs that are designed to dissolve the blood clot over time. There are a variety of different thrombolytic drugs and most of them work by activating certain enzymes that dissolve a portion of the clot.
A second, more severe option, for dealing with a blood clot is surgery. Surgery is often reserved for emergency situations when drugs either won’t work, aren’t available, or the clot has become too severe. There are several different surgical approaches for removing a clot from the IVC and all with varying levels of risk.
Option 3: The Filter
The IVC Filter (IVCF) provided a new approach to this increasingly common problem. It is not intended as an emergency procedure for relieving an existing clot, but rather as a safety net for those who are at a high risk of developing a clot in the in the inferior vena cava. It was a promising idea, but there was always some skepticism regarding the safety of the procedure and the device.
The retrievable IVCF was approved by the FDA in 2003 and it began seeing some use in the medical world. Unfortunately, despite the name, very few of these filters were actually able to be removed after a period of 85 days had passed. Doctors made 13 unsuccessful removal attempts to the dismay of their patients.
How The IVC Is Supposed To Help.
As the name implies, the IVCF works in the IVC to filter out blood clots. It acts as a sort of net that catches any clot moving from the lower body into the IVC. Blood will continue to flow normally around the clot trapped within the filter. Anticoagulants work to break down the clot while it is trapped. In time, the clot dissipates and a potentially serious problem is avoided.
The IVCF was prescribed to people who developed multiple pulmonary embolisms over the course of their life even with the help of anticoagulants. It was also prescribed to people who were at risk for developing a clot, but could not take anticoagulants.
If the filter had worked exactly as promised, then it would have been a seriously beneficial medical breakthrough. Many patients began experiencing complications and over the years there were hundreds of complaints and reports filed.
The FDA Releases Warnings
The FDA released a warning in 2010 stating that retrievable IVCFs could pose certain health risks. This warning came after receiving countless reports, including filter migration and punctured organs. To avoid these risks, the FDA recommended that the filter should be removed as soon as the risk for experiencing a clot had declined in the patient.
The 2010 warning included details on the 900 complaints the FDA reviewed regarding the use of the filter. They were said to lead to 328 migrations in the blood stream and 70 filter perforations. Obviously not the intended function of the device and a reason to cause alarm.
The FDA released a new statement in 2014. This time they advised patients to have their filters removed between day 29 and 54 after receiving the implant. Those who had just received their implants could use this advice according, but there were hundreds of patients who were long past this time frame.
Patients Begin Filing Lawsuits
IVC lawsuits began rolling in after this statement was released because previous patients had never been advised regarding this time frame. The topic of the litigation includes failure to warn patients about the dangers, defects in the design and manufacturing, negligence, and misrepresentation. Many patients had experienced serious harm and sometimes even death because of the filters.
Cook Medical and C.R. Bard are the primary target of these lawsuits. They have manufactured five different products that are present in a majority of the claims. These products include the Bard G2 Filter, Cook Celect Filter, Bard Recovery Filter, Cook Gunther Tulip Filter, and Bard G2 Express Filter.
The first lawsuits against Bard were filed in 2012 and that number increased to more than 100 in a short period of time. Bard settled a case in 2015 in which one of their filters broke inside of the patient’s body, traveled through the blood stream, and punctured their heart.
Getting The Help You Need
If you have received an IVC filter or know someone who has, then you can take steps to ensure you get the help you need. Even those who have not been harmed because of the filter can still be part of a lawsuit requesting to be compensated for medical monitoring and additional expenses related to the Bard IVC filters.
If you have been harmed and believe it is a result of an IVC filter, then you most certainly deserve compensation from the responsible parties. Your first step should be to contact a professional attorney with experience in medical cases. Finding the right attorney can place you on the fast track to getting your case before the courts as soon as possible. You shouldn’t be forced to wait any longer.