NBC Investigates C.R. Bard Recovery, G2 IVC Filter Lawsuits Filed. Inferior vena cava (IVC) filters are small, net-like devices used to trap blood clots before they can reach the lungs, preventing a fatal condition known as pulmonary embolism. Typically, IVC filters are used in patients who are unable to take traditional oral anticoagulants. Some IVC filter manufacturers, including C.R. Bard and Cook Medical, are facing lawsuits alleging that the devices led to serious, sometimes life-threatening complications. Plaintiffs allege that the devices can break or fracture within the blood vessel, and then migrate (embolize). Some suits also allege difficulty retrieving the IVC filter.
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.
C.R. Bard IVC filter lawsuits allege that the company knew about the risks but failed to warn patients or the medical community. An NBC News investigation released in September 2015 raised questions about the device, its approval and the way Bard addressed adverse event reports regarding the Recovery IVC filter. According to NBC, Bard knew that the Recovery filter was associated with at least 27 reports of death and 300 reports of non-fatal adverse events, but did not recall the blood clot-catching device. Instead, NBC reports, Bard merely replaced the filter with a similar model, the G2 series, in 2005.
NBC also raised questions about the approval of the Recovery IVC filter. Kay Fuller, a regulatory specialist who was recruited by Bard to help gain clearance for the Recovery IVC filter, told NBC that when she raised safety concerns, she was brushed aside. “It was basically, you know, if you continue to pursue these questions, that I was going to be asked not to be on the team,” Fuller said to NBC. “And I was shocked.” She reportedly told her boss she would not sign the paperwork until her concerns were addressed, but an application submitted to the FDA appears to have her signature on it. Commenting on this, Fuller told NBC “That’s not my signature,”
NBC reported on Bard IVC filters again in December 2015, this time focusing on the G2 filter series. The newer model appeared to trigger similar complaints, but Bard reportedly did not issue a recall. According to NBC, the G2 series was associated with dozens of deaths and hundreds of injuries. NBC cites a confidential company memo where a Bard vice president cited “problems with…migration,” “tilting” and “perforation” with the G2. Referring to IVC filters that did not have these problems, he said “Why shouldn’t doctors be using that one rather than the G2?”
NBC also released a confidential study conducted in 2004. The study found that the Recovery was linked to higher rates of relative risk for death, filter fracture and movement compared to its competitors. An outside doctor hired to conduct the study advised, “Further investigation…is urgently warranted.”
Several Bard IVC filter lawsuits have subsequently been filed alleging injuries and failure to warn. A multidistrict litigation (MDL) has been established for federal lawsuits alleging injuries from the Bard Recovery, G2, G2X, G2 Express, Eclipse, Meridian and Denali IVC filters. The goal of an MDL is to make complex litigation move along more quickly and efficiently. This type of mass tort, established by the U.S. Judicial Panel on Multidistrict Litigation (JPML), consolidates similar lawsuits to one court before one judge. Plaintiffs in the Bard IVC filter MDL commonly allege that the device caused injuries such as device fracture, embolization and difficult retrieval. Bard is accused of knowing about these risks but failing to warn patients or the medical community.
Cook Medical IVC Filter Lawsuits
Parker Waichman notes that similar lawsuits have been filed against Cook Medical, who is being sued over the Celect and Günther Tulip IVC filter models. A Cook Medical IVC filter MDL has been established in Indiana before U.S. District Court Judge Richard Young. Court records show that the MDL contains over 1,000 lawsuits.
As with Bard IVC filter lawsuits, plaintiffs in the Cook Medical IVC filter MDL allege that the device is prone to break in the blood vessel, perforating the IVC and migrating to other parts of the body. Cook Medical allegedly failed to warn patients and their physicians about the risks.
Court records show that Judge Young has outlined the schedule for bellwether trials, the first lawsuits in an MDL to be heard by jurors. Bellwether cases are selected because the plaintiffs usually represent the majority of the litigation. As such, the outcome of bellwether cases is used to predict how most cases would proceed at trial. Bellwether trials can help reach resolution more quickly; if juries award large verdicts to bellwether plaintiffs, for instance, companies may be more inclined to settle. Two bellwether cases involve plaintiffs who allege difficult IVC filter retrieval. One bellwether plaintiff underwent two years of advanced retrieval techniques to remove the filter.
IVC Filter Background
IVC filters are placed in the inferior vena cava, a major vein bringing blood from the rest of the body back to the heart and lungs. These devices are placed in patients at risk for pulmonary embolism, where a piece of a blood clot breaks off and becomes stuck in the lungs. Some IVC filters are permanent while others can be removed once the patient is no longer at risk for pulmonary embolism.
In May 2014, the FDA said IVC filter complications are more likely to occur when IVC filters are left in the body for long periods of time.
Adverse events reported with IVC filters include migration, filter fracture, embolization (where the entire filter or filter fragments move to the heart and lungs), perforation of the IVC and difficult retrieval. IVC filters were cleared through 510(k), a process that permits devices onto the market without requiring manufacturers to submit data proving the product is safe and effective. Devices approved through 510(k) only need to be similar enough, or “substantially equivalent”, to a previously approved device.