IVC Filters May Break Apart Within the Body

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

IVC Filter Pieces May Break Off, Remaining in the Body

The human body has two large veins, which are known as the vena cavas. These are the body’s largest veins and are responsible for carrying deoxygenated blood to the heart. The inferior vena cava, also known as the IVC, is the vein that carries blood from the lower body to the heart.

A patient is often implanted with an IVC filter if he/she is diagnosed with a blood clot that may travel to the heart, lungs, or brains and are diagnosed with deep vein thrombosis (DVT); if he/she suffered a serious accident such as a serious fall, a gunshot or stab wound, or a car accident; or if the patient suffered a serious injury such as damage to the spinal cord. Patients unable to tolerate blood thinners or for whom blood thinners are not effective may require implantation with the device to help ensure potential blood clots do not travel to major organs.

As many as 250,000 IVC filters are implanted into patients’ bodies annually and are also used in individuals who have undergone orthopedic or gastric surgery, but are primarily used in individuals unable to take blood thinners such as Coumadin (warfarin).

The devices are described as “spider shaped” or as looking similar to a small cage and are about one-and-a-half inches in size and constructed of metal. They are implanted in the IVC and are designed to trap blood clots until the clots dissipate and should then be removed or retrieved.

In 2012, a nurse from Georgia was flying to San Francisco to visit her son she felt severe pain in her chest. Unknown to her at the time, an IVC filter had fractured in her body. She was in extreme distress when the plane landed and was rushed to the hospital. An X-ray revealed that two small metal tines had broken away from the IVC retrievable filter that was implanted following an orthopedic surgery she underwent in 2008 to correct problems with an ankle after a fall at work.

Her physicians discovered that one of the broken tines had perforated her pericardium (the fibrous sac surrounding the heart) and pierced her heart muscle. The bleeding in her chest was copious and without immediate surgery to remove the tine and repair the puncture, the injury may have become fatal. The IVC filter with the broken tines was a C.R. Bard G2 IVC retrievable filter. Three years after the event the woman has returned to work; however, doctors were unable to locate the second tine, which remains in her body.

Protocol indicates that IVF retrievable filters may be removed or left in the vena cava for long periods of time. Meanwhile, the U.S. Food and Drug Administration (FDA) issued two warnings over IVC filter safety and efficacy, recommending the devices be removed from patients’ bodies as soon as the concern of pulmonary embolism and blood clots has passed. In a public statement, the agency indicated that IVC implants might fracture within a patient’s body, possibly traveling through the bloodstream to vital areas of the body, potentially puncturing veins and organs. IVC filter pieces may become lodged in high-risk areas, including the intestines and other locations in which surgical removal is impossible, according to NBC News. The FDA also warned about IVC failure risks in 2014 and recommended that retrievable IVC filters be removed between 29 and 54 days following implantation. Research also reveals that IVC filters’ risks outweigh their benefits if the device remains in the body for more than two months. The first warning was issued in 2010. The second warning, issued in 2014, was updated to include then-new research that was published in the Journal of Vascular Surgery that revealed that “the mathematical model suggested that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.”

IVC Filter Injuries Lead to Increased Lawsuits

The product liability lawyers and personal injury attorneys at Parker Waichman LLP are closely monitoring events in the IVC filter litigation against C.R. Bard, Cook Medical, Cordis Corporation, and Boston Scientific. The firm continues to offer free legal consultations to individuals with questions about filing an IVC filter lawsuit.

Mounting injury reports involving IVC filter fractures have led to patients filing lawsuits against IVC manufacturers, including Boston Scientific, Cook Medical, Cordis Corporation, and C.R. Bard over allegations that IVC filters were defectively designed, according to The State Journal. The first lawsuit brought against Cook Medical is scheduled for trial in early 2017. Patients allege suffering severe pain, bleeding, and additional blood clots. As the FDA warned, issues appear to be associated with the length of time that the IVC filter remained in the patient’s body.

The key products involved in the lawsuits include the Bard Recovery filter, the Bard G2 filter, the Bard G2 Express filter, the Cook Gunther Tulip filter, the Cook Celect filter, and the Boston Scientific Greenfield filter.

Currently, there are two multidistrict litigations (MDL) organized in the United States that involve hundreds of plaintiffs. One MDL has been organized in Arizona and the other in Indiana. Dozens of additional individuals have filed lawsuits nationwide and bellwether trials are expected in 2017.

Bellwether cases are the first few lawsuits in a mass tort that reach trial. Plaintiffs selected often represent most of the litigation or a cross-section of the litigation. Bellwether trials are used to help determine the direction of the overall litigation. Outcomes of bellwether trials often help to facilitate settlement talks, for example, when juries award large verdicts to the plaintiffs. In an MDL, each plaintiff retains a separate, distinct lawsuit and may either decide to continue to trial or to accept a settlement offer if one is made. To streamline pretrial matters, including discovery and testimonials, the lawsuits are organized in an MDL and transferred to a single court.

Many of the IVC filters on the market today were approved via the 510(k) route, which is a method of clearing medical devices. The clearance route has been associated with controversy and is considered by many as a lax method in which to release a device to market. The 510(k) is a regulatory route that enables device manufacturers to receive approval for their devices without having to undergo clinical testing as long as the manufacturers are able to prove that their products are “substantially equivalent” to a previously approved (sometimes described as “predicate”) product. IVC filters were cleared in 1979, at which time only 2,000 devices were implanted. The number of IVC filter implants rose to 167,000 by 2007.

Filing an IVC Filter Lawsuit

If you or someone you know suffered injuries related to the use of an IVC filter implant, you may have valuable legal rights. Our IVC filter lawyers offer free, no-obligation case evaluations. For more information, call 1-800-YOURLAWYER (1-800-968-7529).