IVC Filter Lawsuit Filed Against Device Maker. A Virginia woman just filed a lawsuit, joining over 1,000 other plaintiffs in IVC filter litigation brought against device maker C.R. Bard. The woman alleges she experienced complications with the C.R. Bard Meridian IVC filter.
The woman was implanted with the Meridian IVC filter in October 2012 to help ensure she did not suffer from a pulmonary embolism, a serious, often deadly, injury that occurs when a blood clot forms in the legs and travels through the body to the heart and lungs.
Since the mid-2000s, C.R. Bard has had issues with its IVC filters. C.R. Bard’s first IVC filter-the Recovery filter-was recalled in 2005 over mounting complication reports that included a number of deaths.
Since then, C.R. Bard produced other new IVC filter models; however, patients alleged experiencing similar issues. In 2010, the U.S. Food and Drug Administration (FDA) issued a warning to patients and physicians that IVC filters should be removed from patients’ bodies once the threat of a pulmonary embolism has passed.
Thousands of other patients nationwide also allege having suffered significant serious side effects due to IVC filters that include device migration or fracture; vena cava wall perforation; or device-or device piece-embolization into the body’s vital organs.
When the agency received nearly 1,000 adverse event reports, the federal regulators advised patients that the risk of IVC failure increase the longer the device remains in the body.
Judge David G. Campbell is overseeing the Bard IVC multidistrict litigation and, in May 2016, put forth the case selection process to identify 50 cases that are suited to go to trial first; these from some 400 pending cases in federal court, according to The Legal Examiner. The judge is selecting initial cases for bellwether trials.
Bellwether trials are the preliminary cases brought to trial in a large litigation, such as this one, that enable both sides in the cases to determine how juries may react to presented evidence and legal arguments that would be seen if similar cases went to trial.
Bellwether trial outcomes are critical to the disposition of the remaining cases. For example, when a trend is seen in bellwethers cases, a settlement may be quickly negotiated or the remaining cases may be brought to trial.
What is an IVC Filter?
The human body has two large veins known as the vena cavas. These veins are the body’s largest and they are responsible for carrying deoxygenated blood to the heart. The inferior vena cava-also known as the IVC-carries blood from the lower body.
When a patient is diagnosed with a blood clot that may potentially travel to the heart, lungs, or brains in patients diagnosed with deep vein thrombosis (DVT); if a patient has 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, the patient is often implanted with an IVC filter.
Patients who are not able to tolerate blood thinners or for whom blood thinners are not effective may also need to be implanted with an IVC filter to help ensure blood clots that may form do not travel to major organs.
IVC filter devices are described as “spider shaped” or as looking similar to a small cage and are implanted in the inferior vena cava-the vein that travels to and from the legs and the heart.
The filters are typically one-and-a-half-inches in size and made of metal and are inserted into the IVC where they are meant to trap blood clots traveling to the heart, lungs, and brain until the clots dissipate.
Issues Associated with IVC Filters
Many of the IVC filters on the market today were approved via the 510(k) route, a method of clearing medical devices that has been associated with controversy and is considered by many as a lax method in which to release a device to market.
Many IVC filters were approved through the 510(k), which 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.
The FDA approved IVC filters in 1979, at which time only 2,000 devices were implanted. The number of IVC filter implantations rose to 167,000 by 2007.
The FDA has issued two warnings over IVC filter safety and efficacy and recommends that IVC filters be removed from patients’ bodies as soon as the concern of pulmonary embolism and blood clots has passed.
In one of its public statements, the agency indicated that IVC implants may fracture while within a patient’s body, potentially traveling through the bloodstream and to vital areas of the body, possibly puncturing veins and organs.
IVC filter pieces may become lodged in high-risk areas, such as 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, recommending that retrievable IVC filters be removed between 29 and 54 days following implantation.
In fact, research reveals that IVC filters’ risks outweigh their benefits if the device remains in the body for more than two months.
Due to mounting injury reports involving IVC filter fractures, numerous patients have filed 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.
In fact, the first lawsuit brought against Cook Medical is scheduled for trial in early 2017.
Some of the injuries patients allege include severe pain, bleeding, and additional blood clots. And, as the FDA warned, issues appear associated to the length of time the IVC filter remained in the patient’s body.