Medical device company Bard is facing thousands of lawsuits for serious injuries caused by its Recover and G2 IVC filter implants.
Bard IVC Filter Lawsuit
C.R. Bard, the manufacturer of the Recovery and G2 IVC filter implants is facing thousands of lawsuits filed by patients or loved ones of those who suffered serious injury due to the devices.
IVC filter failure, including the Bard Recovery and G2 IVC devices, may result in 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 event and has resulted in thousands of lawsuits filed against the manufacturer.
The 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 to go to trial was settled for an undisclosed amount after only 10 days of litigation. Federal courts are in process of conducting bellwether trials with future settlements to be determined.
Medical device manufacturers, Cook and Greenfield are also facing lawsuits for their IVC filters.
Bard 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 manufacturers 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.
Bard 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 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 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.
Bard IVC Filter Claims
The first Bard IVC filter lawsuit went to trial in 2015 and was settled 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.
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. Bard and other companies have been accused of manufacturing defective devices and of failure to adequately warn the medical community and the public about the risks and potential dangers of the IVC devices.
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 advice from an attorney.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use, U.S. Food and Drug Administration (8/2010)
- Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication, U.S. Food and Drug Administration (5/2014)
- IVC Filter Trials Forging Ahead, With 3rd Bard Case Starting Next Tuesday, National Law Journal (9/2018)