IVC Filter Lawsuit
The medical implant lawyers with Baron & Budd are currently investigating lawsuits concerning injuries and deaths due to defective inferior vena cava, or IVC filters. These devices are designed to help prevent blood clots from entering the lungs and causing a pulmonary embolism (PE). But when they fracture or migrate to other areas of the body, devastating injuries – which are sometimes fatal – can result. Please complete our contact form or call us at 866-731-7909 to see if you may be eligible to file an IVC filter lawsuit.
What is the Inferior Vena Cava?
The inferior vena cava is the body’s largest vein, transporting blood from the lower half of the body to the heart. There are two vena cava in the body – The other vena cava, the superior vena cava, takes blood from the head, the arms and other areas of the upper portion of the body.
When a blood clot is located in your arms, legs, or pelvic region, it is referred to as a DVT, or deep venous thrombosis. While a DVT is usually not life-threatening, it can be fatal if it travels to the lungs and becomes a PE that chokes off the blood supply. Hundreds of thousands of people die from this problem each year.
What is an IVC Filter, and How Does it Work?
An IVC filter is a small device made of metal, typically implanted to provide temporary protection against a PE. Resembling a small cage, an IVC filter is designed to break up a blood clot before it can get into the lungs. There are five primary manufacturers of IVC filters: Cook Medical, C.R. Bard, Boston Scientific, Johnson & Johnson, Braun Medical and Cordis.
An IVC filter is typically inserted via a catheter into the inferior vena cava, usually through a small incision in the groin. Once the danger of blood clots has passed, the filter is usually removed through the use of a snare-like device that latches onto a hook at the end of the IVC filter. There are, however, some IVC filters that are designed to be permanently implanted in a patient.
Until 2002, Cook and Bard marketed filters as optionally retrievable. This means they could be used for either permanent or temporary implantation. If a patient faces a long-term threat from a PE, the filter will typically be permanent. If only short-term protection is needed, then a retrievable IVC filter will be used.
Doctors will usually only recommend the use of an IVC filter if a patient is not a candidate for blood-thinning medication. This could be due to an adverse reaction to blood thinners, a recent surgery or some sort of trauma.
While there is still a risk of a blood clot bypassing an IVC filter and entering the lungs, the main danger of the device is its tendency to fracture and move to other areas of the body. The main models of IVC filter that have been linked to this problem are: Cook Medical’s Cook Celect and Gunther Tulip; as well as C.R. Bard’s G2, Eclipse, Meridian, Denali, and G2X.
There have been reports of filters perforating adjacent organs and vessels after fracturing, as well as incidents where the entire device migrated upward or downward to other areas of the body. Filters have also shifted or tilted, making them nearly impossible to remove. In the case of a device fracture (also known as a device embolism), a part of the filter can affect the liver, kidneys, lungs or heart. In many instances, it may do more harm to remove the fractured part than simply leaving it embedded in the organ where it migrated.
The U.S Food and Drug Administration (FDA) has issued several safety warnings regarding the use of retrievable IVC filters. In 2010, for example, the FDA reported that it had received more than 900 reports of people suffering adverse events following the implantation of a filter. These events included device embolization, fractures, perforation of organs, and device migration. The agency recommended that doctors remove filters as soon as they were no longer needed. The FDA later updated that warning in May 2014 to recommend that doctors take out IVC filters within 29-54 days of implantation.
Then, in July 2015, the FDA issued a warning letter to C.R. Bard. In it, the agency stated that the company’s Recovery Cone Removal System had neither been approved nor cleared by the FDA. As a result, there is apparently no approved method to remove that manufacturer’s filters. The letter also informed Bard of the following:
- The company was not following good manufacturing practices in the manufacture, storage, and packaging of IVC filters.
- Bard did not properly establish and maintain procedures in regard to reviewing and evaluating complaints relating to the G2, G2X, and Eclipse models.
- Bard did not report information that reasonably suggested its devices had malfunctioned, and those malfunctions could lead to either a severe injury or death.
In 2004, Bard, according to court documents, hired Dr. John Lehmann, a litigation consultant, to report on the migration and fracture rate of the company’s new IVC filters compared to previous models of the device. It did so without notifying the FDA of potential malfunctions that could result in part of a filter breaking loose and traveling to other areas of the body. The document was supposed to be confidential, but was mistakenly disclosed during the discovery process of a lawsuit in December 2012.
Several lawsuits have been filed around the country against Cook and Bard alleging the manufacturers were aware of the risks associated with IVC filters, as well as the importance of removing the filters as quickly as possible. However, the suits allege, the manufacturers not only tried to conceal these facts, they continued to advertise and promote the filters as being safe and effective for the prevention of PEs. More than 100 lawsuits have been filed against Cook and dozens have been filed against Bard.
These are the main claims that plaintiffs in these lawsuits are making against Cook and Bard:
- Negligence – Plaintiffs allege Cook and Bard failed in their duty to exercise reasonable care in the design, development, manufacturing, and other aspects of the production of IVC filters. This includes the duty to ensure that use of the device would not lead to unreasonable side effects.
- Defective Design
- Failure to Warn
- Failure to Adequately Test
The attorneys with Baron & Budd are working on behalf of clients to obtain compensation for the harm they have suffered due to the implantation of an IVC filter. Damages we are seeking include proper compensation for injuries, costs of filing a lawsuit, interest, punitive damages and others.