IVC Filter Lawsuit
C.R. Bard and parent company Becton Dickinson, manufacturer of the Recovery and G2 Inferior Vena Cava (IVC) filter implants are facing thousands of lawsuits filed by patients or loved ones of those who suffered serious injury due to the devices. Other companies have also been named in thousands of IVC filter lawsuits including Cook Medical, Boston Scientific, and Cordis.
IVC filter failure, including the Bard Recovery and G2 IVC devices, may result in a number of serious adverse events including:
- IVC filter fractures
- Filter migration
- Severe pain
- Perforation of blood vessels, organs and other tissues including the heart and kidneys
- New blood clot development
- Pulmonary embolism
- Deep vein thrombosis
- Heart failure
Complaints about the Bard IVC filters began to surface as early as 2004, but the company continued to sell the devices and did not notify the U.S. Food and Drug Administration (FDA) of device failures. Bard has been cited for eight violations of federal law over their IVC filters and failure to take appropriate actions. This may have caused thousands of serious injury events and has resulted in thousands of lawsuits filed against the manufacturer.
IVC Filter Concerns
IVC stands for “Inferior Vena Cava” which is the largest vein in the body. It is used for transporting blood from the body back to the heart so that it can be pumped to the lungs for reoxygenation. IVC filters were intended to be used in have an increased risk of blood clots and are unable to take anticoagulant medication.
The IVC filters are “basket” type devices which are placed inside the IVC vein to “catch” any blood clots in the bloodstream so they cannot pass to the lungs and cause a pulmonary embolism which is often fatal. IVC filters were first approved by the FDA as “permanent” devices and intended to be left in place. Approval was later expanded to be listed as “retrievable” devices, however in 2014, the FDA stated that IVC filters should be removed within 29 to 54 days.
The longer a device remains in place, the more difficult it becomes to remove. Attempted retrieval has often caused harm and removal of many devices has never been attempted, leaving the devices in place, and often resulting in device fracture or migration.
IVC filters were intended to protect patients’ health but several of these devices, including the Bard Recovery and G2 IVC filters have resulted in serious failure and caused serious harm. Hundreds of patients have filed lawsuits against Bard regarding injury caused by the devices. Bard has also faced thousands of lawsuits for other devices which resulted in serious injury including transvaginal mesh.
Bard’s Recovery IVC filter and G2 IVC filter
C.R. Bard is a New Jersey-based medical device manufacturer which has an estimated annual revenue of $3 billion. Bard manufactures a wide range of medical devices for surgical, urological, and gynecological treatments and has been involved in a number of high-profile medical device lawsuits in addition to the IVC filter lawsuits.
Bard Recovery IVC filter was approved for use in 2003 but was discontinued and replaced by the G2 IVC filter due to problems with the Recovery device which began to emerge as early as 2004. As both devices were approved using the FDA’s 510(k) pathway which allows manufacturers to avoid costly clinical trials by claiming that the new devices are similar to devices already on the market, neither Bard Recovery nor Bard G2 IVC Filter were ever tested in humans prior to marketing.
Bard has been cited for a number of violations in IVC filter manufacturing facilities, for failing to report device malfunction, for marketing an unapproved medical device and for misfiling patient complaints including at least one death.
IVC Filter Adverse Events
By 2010, over 921 serious adverse event reports had been received by the FDA showing IVC filters causing severe injury including:
- Device migration or movement from the original implant site
- Filter fracture or perforation resulting in failure of the filtering device or formation of new clots
- Device embolism involving parts of the device which break off and travel to other organs such as the heart or kidneys
In 2010, the FDA issued a warning statement to physicians regarding the potential for complications. The advisory stated that complications were more likely if IVC devices were left in place for too long and recommended that the implants be removed as soon as the danger of blood clots had passed for each patient.
Several medical journal articles published between 2010 and 2013, showed the continuing trend of high device failure rate including Bard Recovery and G2 IVC filters. One journal reported that though quick device removal was recommended, only 9 percent of all implanted devices had actually been removed.
Because of continuing problems, in May of 2014, the FDA issued an additional warning update, stating that IVC filters should be removed within 29 to 54 days after implantation.
IVC Filter Lawsuit Settlements
The very first Bard IVC filter lawsuits were filed in state courts in California and Pennsylvania in 2012 but additional lawsuits in federal courts followed. In February of 2015, the first case set for trial was settled for an undisclosed amount after only 10 days of litigation.
The plaintiff, Kevin Phillips, had suffered serious harm when his Bard Recovery IVC filter failed, breaking apart and sending a metal component through his blood vessels, puncturing his heart. He required open-heart surgery and underwent a lengthy recovery period.
Federal Bard IVC lawsuits were consolidated into multidistrict litigation in the U.S. District Court for the District of Arizona in August 2015. In March 2018, a jury awarded $3.6 million in the first bellwether trial to the victim who claimed injury by a broken IVC filter.
Other bellwether cases have resulted in wins for Bard or have been settled out of court for undisclosed amounts. Federal courts are still in the process of conducting additional bellwether trials with future settlements to be determined. Over 7,000 Bard MDL lawsuits may still be pending in the Arizona court.
Federal Cook Medical lawsuits naming Cook’s Celect and Tulip IVC Filters were consolidated into multidistrict litigation (MDL) in in the U.S. District Court for the Southern District of Indiana in 2015. After a number of bellwether cases were dismissed, the first bellwether case trial in February 2019 resulted in a jury award of $3 million to the plaintiff who suffered heart damage and migration of her Cook Celect IVC filter which had fractured.
Separately, in May 2018, a trial in state court in Texas resulted in a judgment of $1.2 mill for the plaintiff who had experienced aorta and small intestine injury by a Cook Celect IVC filter. Cook may be facing an additional 6,000 cases still pending in court systems.
Several IVC Filter lawsuits have also been filed against Boston Scientific for its Greenfield filter. Though no multidistrict litigation cases have been established, at least one case was settled out-of-court in 2017 for an undisclosed amount. The company may be facing additional lawsuits as well.