Bard, the manufacturer of the Recovery and G2 IVC filter implants is facing hundreds of lawsuits by patients who suffered serious injury caused by the devices. Cook, another medical device company is also facing lawsuits regarding its Celect IVC Filter and Gunther Tulip IVC Filter. The companies have been accused of manufacturing and marketing defective devices and of failure to adequately warn the medical community and the public about the risks and potential dangers of the IVC devices.
Complaints about the IVC filters began to surface as early as 2004, but the company continued to sell the devices and did not notify the FDA of complaints or device failures. The first lawsuits regarding medical injury caused by Bard IVC devices 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 to go to trial was settled for an undisclosed amount after only 10 days of litigation.
The plaintiff, Kevin Phillips 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.
Other IVC filter injury lawsuits have yet to be settled, in both state and federal courts, including:
- Lisa Davis – a portion of her Bard G2 filter lodged in the right heart ventricle.
- Lessie Tillman – a piece of her Bard G2 IVC filter migrated to the renal vein.
- Melissa Ebert – a part of her Bard G2 IVC filter detached and migrated to her pulmonary artery.
- Sarah Bedneck – her Bard G2 IVC filter fractured, lodging in the Vena Cava and other organs
- Kelly Vlasvich – metallic pieces of her Bard G2 IVC filter traveled to heart and lungs causing the outer sac of her heart to fill with blood (cardiac tamponade)
Hundreds of Bard IVC filters remain unsettled in federal and state courts and many more may be expected. Many Cook IVC Filter lawsuits also remain unsettled.
Past victims of medical injury caused by medical devices have sued for medical costs, lost wages and pain and suffering. Some victims have also received punitive damages when it could be proven that the company knowingly sold a defective device.
A lawsuit is no guarantee of a settlement as each case of medical injury is unique and must be evaluated separately. If you or a loved one has been injured by a Bard IVC filter, you may be eligible for compensation and should seek legal assistance.
About IVC Filters
IVC stands for “Inferior Vena Cava” which is the largest vein in the body, used for transporting deoxygenated blood from the body back to the heart so that it can be pumped to the lungs for reoxygenation. IVC filters placed inside the IVC vein to prevent blood clots that may form in the body from traveling to the lungs. Patients who receive IVC filters most commonly have an increased risk of blood clots and are unable to take anticoagulant medication. The IVC filters are “basket” type devices which “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 as “permanent” devices and intended to be left in place. Approval was later expanded to be listed as “retrievable” devices and 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 and Cook IVC filters have resulted in failure which 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.
About Bard Recovery IVC filter and G2 IVC filter
Bard, also known as C.R. Bard, is a New Jersey-based medical device manufacturer which has an estimated annual revenue of $3 billion. Bard manufacturers a wide range of medical devices for surgical, urological and gynecological treatments.
The Bard Recover IVC filter was approved for use in 2003 but was replaced by the G2 IVC filter due to problems with the Recover device. Both devices were approved using the FDA’s 510(k) pathway which is a “shortcut” that allows manufacturers to avoid costly clinical trials by claiming that the new devices are similar to devices already on the market. Neither the Bard Recovery IVC Filter nor the Bard G2 IVC Filter were ever tested in humans prior to marketing.
By 2010, over 921 serious adverse event reports had been received by the FDA regarding IVC filters causing severe injury due to:
- 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
Due to the number of reports, in 2010, the FDA issued a warning statement to physicians regarding the possibility of complications. The advisory stated that complications were more likely if IVC devices were left in place to 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 the 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 failure, including the Bard Recovery and G2 IVC devices, may result in serious adverse events including:
- Severe pain
- Perforation of blood vessels, organs and other tissues including the heart and kidneys
- New blood clot development
- Pulmonary embolism
- Heart failure