IVC Filter Lawsuits Allege Fracture, Embolization ComplicationsDec 5, 2016
IVC Filter Lawsuits Filed Against C.R. Bard
Thousands of lawsuits have been filed over inferior vena cava (IVC) filters, devices that are placed in a major vein in order to stop blood clots from reaching the heart and lungs, where they can be life-threatening. Court records show that IVC manufacturers, including C.R. Bard, are being sued. Plaintiffs in the litigation allege that the device broke or fractured within the blood vessel and led to complications such as embolization. Some lawsuits allege that IVC filter complications resulted in difficult retrieval.
The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits involving allegedly defective drugs and medical devices. The firm continues to offer free, no-obligation case evaluations.
In August 2015, the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation (MDL) for federal lawsuits alleging injuries from the Bard Recovery, G2, G2X, G2 Express, Eclipse, Meridian and Denali IVC filters. An MDL is established when there are many lawsuits with similar allegations. Consolidating them to one court before one judge helps streamline the litigation and makes proceedings more efficient. Plaintiffs in the Bard IVC filter MDL allege that the blood clot-catching device is defective and caused injuries when it broke, migrated and perforated the IVC. Lawsuits allege that Bard was aware of the risks but failed to warn patients or the medical community.
C.R. Bard came under increased scrutiny over its IVC filters following an investigative report released by NBC in September 2015. According to the two-part report, the Bard Recovery IVC filter was associated with at least 27 deaths and 300 reports of non-fatal adverse events. NBC reports that Bard did not recall the filter, which stayed on the market until 2005. Bard then replaced the Recovery with the G2 filter series, which reportedly had the same issues at the recovery.
NBC raised questions about the approval of the Recovery filter. Kay Fuller, a regulatory specialist who was recruited by Bard to help gain clearance for the Recovery IVC filter, says the company ignored her when she expressed safety concerns. She also notes that Bard submitted paperwork to regulators with her name on it, but tells NBC "That's not my signature,"
Another NBC report released in December 2015 focused on the G2 filter series. Reportedly, Bard continued to sell the series despite receiving reports of at least a dozen deaths and hundreds of injury reports. Furthermore, evidence suggests company executives were aware of the problem. In a confidential company memo, a Bard vice president cited "problems with...migration," "tilting" and "perforation" with the G2. He noted that other Bard IVC filters were not associated with these issues, and asked "Why shouldn't doctors be using that one rather than the G2?"
Another point of contention is a confidential 2004 study showing that the Recovery was associated with higher rates of relative risk for death, filter fracture and movement compared to its competitors. An outside physician hired to conduct the study advised, "Further investigation…is urgently warranted."
NBC interviewed Dr. William Kuo, an interventional radiologist who runs Stanford Health Care's IVC Filter Clinic and specializes in IVC filter removal. "All of the data that we've seen in our own studies, as well as other clinician researchers', is that this device consistently fractures, consistently causes major complications," said Dr. Kuo to NBC. "The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted."
Cook Medical IVC Filter Lawsuits
Parker Waichman comments that Bard is not the only device maker to face IVC filter lawsuits. Personal injury lawsuits are also being filed against Cook Medical IVC filters, mostly alleging complications from the Celect and Günther Tulip models. An MDL has been established for Cook IVC filters in Indiana. Court documents indicate that over 1,000 lawsuits have been centralized so far.
As with the Bard IVC filter litigation, plaintiffs in the Cook Medical MDL allege that the IVC filters are defective and susceptible to serious, sometimes life-threatening complications. Cook Medical allegedly failed to warn about the risks associated with its IVC filter devices.
U.S District Court Judge Richard Young, who is overseeing the litigation, has announced the schedule for bellwether trials. Two of the bellwether plaintiffs say the IVC filter remains in their bodies due to complications and one plaintiff had the device removed successfully, but only after one unsuccessful attempt and two years of advanced retrieval techniques.
IVC Filter Background
IVC filters are placed in the inferior vena cava, the major vein in the body transporting blood from the lower body back to the heart and lungs. The small, cage-like devices are typically used in patients who cannot take oral anticoagulants. They are designed to catch blood clots before they get stuck in the lungs, leading to pulmonary embolism. Some IVC filters are permanent and others are retrievable, meaning they are to be removed once the risk of pulmonary embolism has passed.
In May 2014, the U.S. Food and Drug Administration (FDA) warned that IVC filter complications such as migration, filter fracture, embolization (where the entire filter or filter fragments move to the heart and lungs), perforation of the IVC and difficult retrieval, may be more common when left in the body for long periods of time. In response to these concerns, the agency advised physicians to remove IVC filters as soon as the risk of pulmonary embolism passes.
IVC filter lawsuits allege that device makers failed to conduct adequate testing for its devices because they were approved through a 510(k) application. This expedited route allows devices onto the market without clinical testing for safety or efficacy so long as devices are shown to be "substantially equivalent" to a previously approved device. This process is not meant for high-risk devices. 510(k) has come under scrutiny in light of problems with other medical devices, including transvaginal mesh and metal-on-metal hip implants.
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).