IVC Filter Litigation Grows Against C.R. Bard, Cook Medical

0
57
Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

C.R. Bard and Cook Medical Face IVC Filter Lawsuits

Inferior vena cava (IVC) filter lawsuits have been filed against C.R. Bard and Cook Medical alleging that the devices caused injuries. Among other things, plaintiffs allege that the device fractured within the blood vessel, and the broken pieces migrated to other areas, such as the heart. IVC filters are small, cage-like devices implanted in the inferior vena cava to catch blood clots before they reach the heart and lungs.

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.

Lawsuits are being filed over IVC filters, alleging that certain devices are defective and caused injuries related to device fracture. Plaintiffs in the litigation allege that device makers were aware of the risks but failed to warn patients or the medical community.

Court records show that IVC filter product liability lawsuits continue to mount; four lawsuits were filed recently. One lawsuit was filed on Mar. 7, 2017 in the U.S. District Court for the District of Arizona. The plaintiff is an Alabama man who was implanted with the C.R. Bard Recovery IVC Filter in 2007. The lawsuit notes that the Recovery was quietly withdrawn from the market two years earlier in 2005. The plaintiff alleges that, since the action was a withdrawal and not a recall, patients and physicians were not aware of the risks.

C.R. Bard is also being sued by a Nebraska woman who was implanted with a different IVC filter, the Bard G2 IVC filter, in December 2009. The plaintiff states that this device did not undergo clinical testing because it was approved through 510(k), an expedited review process that circumvents clinical testing if the new product is deemed “substantially equivalent” to a previously approved device. In this case, the G2 IVC filter was “substantially equivalent” to the Bard Recovery IVC filter mentioned previously. The complaint was filed in the U.S. District Court for the District of Arizona on Mar. 7, 2017.

Parker Waichman notes that there is some criticism over 510(k), because this process was used to approve certain products that are now controversial. Metal-on-metal hip implants and transvaginal mesh, for examples, were cleared through 510(k) without clinical testing.

On Mar. 7, 2017, an IVC filter lawsuit was filed against C.R. Bard in the U.S. District Court for the District of Arizona. According to the complaint, the plaintiff was implanted with the C.R. Bard Denali IVC filter in March 2016. The plaintiff suffered injuries and complications, allegedly due to the defective nature of the IVC filter. The Denali was approved in 2013; it is a sixth-generation filter, and the only Bard IVC filter remaining on the market.
Cook Medical was named as a defendant in a recent IVC filter lawsuit, filed on Mar. 11, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division). The plaintiff suffered adverse events after being implanted with the Cook Celect Vena Cava Filter in August 2015.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established multidistrict litigations (MDLs) for Cook Medical and C.R. Bard IVC filter lawsuits. Cook Medical IVC filter cases have been consolidated in Indiana before U.S. District Court Judge Richard Young.

IVC Filter Lawsuit Background

The inferior vena cava is a major vein transporting blood from the lower body back to the heart and lungs. IVC filters are typically used in patients who are at risk of blood clot complications, such as those with deep vein thrombosis, but cannot tolerate oral anticoagulants. IVC filters are usually placed to prevent pulmonary embolism, a life-threatening condition where a blood clot gets trapped in the lungs. Some IVC filters can be removed (retrieved).

In May 2014, the U.S. Food and Drug Administration (FDA) issued a Safety Communication on IVC filters. The agency said it received reports of adverse events in patients with IVC filters, including device migration, filter fracture, embolization (where the entire filter or parts of the filter move into the heart or lungs), perforation of the IVC, and difficult retrieval.
The agency said IVC filter injuries may be more likely to occur when the device is left for long periods of time. “These types of events may be related to how long the filter has been implanted,” regulators said. “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,”
Other injuries and complications reported among 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.

In 2015, NBC released two investigative reports focusing on the safety of C.R. Bard IVC Filters. In particular, the reports raised questions about the Recovery and G2 series filters.

In 2010, a study published in the journal Archives of Internal Medicine found that the Bard Recovery and Bard G2 filters had high rates of fracture and embolization, which could lead to life-threatening consequences. Out of 80 patients, 13 (16 percent) experienced at least 1 strut fracture.

A recent study, published in the January 2017 edition of JAMA Surgery, found that placing IVC filters in trauma patients does not increase the chance of survival. The authors noted that IVC filters are increasingly placed in trauma patients “despite a lack of high-quality evidence to demonstrate their efficacy”.

“The research herein demonstrates no significant difference in survival in trauma patients with vs without placement of an IVC filter, whether in the presence or absence of venous thrombosis,” authors concluded. “The use of IVC filters in this population should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place.”

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).