Lawsuits Filed over IVC Filter Fracture, Embolization
Lawsuits are alleging serious, sometimes life-threatening adverse events associated with inferior vena cava (IVC) filters. These small, cage-like devices are intended to trap blood clots before they reach the heart and lungs. However, there have been some reports of the devices breaking or fracturing within the blood vessel, leading to serious injury when parts of the filter perforate the heart or other critical areas.
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 and Cook Medical. The firm continues to offer free legal consultations to individuals with questions about filing an IVC filter lawsuit.
According to court records, one IVC filter lawsuit was filed on behalf of a nurse from Atlanta, who had the C.R. Bard G2 IVC filter placed. The complaint states that in 2012, she felt sudden and excruciating pain in her chest. She was in a plane at the time, and the pain began while her flight arrived at its destination. The nurse immediately went to the hospital, where an x-ray showed that two small metal tines on the IVC filter had broken off. One of them perforated her pericardium, the fibrous sac surrounding the heart.
The plaintiff had the IVC filter placed in 2008. The inferior vena cava is a major vein transporting blood from the lower body back to the heart and lungs. IVC filters placed in this blood vessel to trap blood clots before they can get stuck in the lungs, leading to a life-threatening condition known as pulmonary embolism. Typically, patients receive IVC filters because they cannot take oral anticoagulants.
According to the complaint, one of the tines pierced the plaintiff’s heart muscle when it perforated the pericardium, causing excessive bleeding in the chest. The IVC filter injury could have caused death without immediate surgery, the lawsuit states. Doctors were never able to locate the other broken tine, the plaintiff states.
IVC filter lawsuits have been filed against C.R. Bard, as well as Cook Medical.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated federal Bard IVC lawsuits into a federal multidistrict litigation (MDL). An MDL is a type of mass tort that transfers lawsuits with common questions of fact to one court before one judge. This type of consolidation makes the legal process faster and more efficient because it eliminates duplicate discovery and streamlines proceedings. The Bard IVC filter MDL contains lawsuits involving the Bard Recovery, G2, G2X, G2 Express, Eclipse, Meridian and Denali IVC filters.
In 2015, NBC News released two investigative reports calling attention to Bard IVC filters, specifically the Recovery and the G2 series. The report called attention to adverse events and deaths related to the products, and raised questions about why Bard did not issue a recall. NBC reported that the G2 series was released to replace the Recovery, but patients reported the same issues.
In 2014, the U.S. Food and Drug Administration (FDA) warned that IVC filter adverse events may include device migration, filter fracture, embolization (where the filter or parts of the filter move into the heart and lungs), perforation of the IVC and difficult retrieval. Regulators warned that these injuries may occur more frequently in cases where IVC filters are left for long periods of time. “These types of events may be related to how long the filter has been implanted,” the agency said.
Other adverse events that may occur in IVC filter patients include lower limb deep vein thrombosis, where a blood clot forms in one of the deep veins of the leg, and occlusion. “The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides,” the notification states.
Cook Medical IVC Filter Lawsuits
Parker Waichman notes that Cook Medical is also being sued over its IVC filters. An MDL has been established for Celect and Günther Tulip IVC filters in Indiana before U.S. District Court Judge Richard Young. At least 1,000 lawsuits have been filed, according to court records.
As with the C.R. Bard litigation, plaintiffs in the Cook Medical MDL allege that the IVC filter is defective and caused injuries stemming from filter fracture and embolization. Lawsuits allege that the device maker was aware of these risks but failed to warn plaintiffs or the medical community.
Court documents show that bellwether trials have been scheduled in the Cook Medical IVC filter MDL. Bellwether cases are used to predict how most of the litigation would proceed; they are the first few lawsuits in a mass tort to go to trial. The outcome of bellwether trials is used to gauge how jurors would weigh most cases. For example, defendants may be more inclined to settle lawsuits quickly if jurors award large verdicts to the plaintiff.
For Cook Medical IVC filter bellwether cases, plaintiffs allege difficult retrieval due to adverse events. One lawsuit is filed on behalf of a plaintiff who underwent two years of advanced retrieval techniques to remove the device.
Plaintiffs in the litigation point out that IVC filters were approved through 510(k), meaning manufacturers did not have to submit clinical data proving that devices were safe and effective prior to obtaining approval. This contrasts to the FDA’s stricter premarket approval process, which does mandate clinical testing. 510(k) is a fast-track route that only requires products to be “substantially equivalent” to a previously approved device, even if that device had safety issues of its own.
Substantial equivalence means that a product is at least as safe as its predicate. However, safety advocates have argued that 510(k) is not appropriate for certain medical products. The route was never intended for high-risk devices. Due to a regulatory loophole, however, some high-risk devices were cleared through 510(k).
Filing an IVC Filter Lawsuit
If you or someone you know has questions about filing an IVC filter lawsuit, contact the personal injury attorneys at Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).