IVC Filter Lawsuit
Bard is facing several hundred lawsuits by patients who have had the Recovery and G2 IVC filters implanted, resulting in injury. Plaintiffs claim that the company marketed poorly designed devices and failed to warn the medical community and public about potential risks.
The first lawsuits regarding the Bard devices were filed in 2012 in California and Pennsylvania state courts. In October 2014, federal lawsuits were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Indiana, overseen by U.S. District Judge Richard L. Young.
The first case to go to trial was settled in February of 2015, after only 10 days of litigation. Kevin Philips suffered serious medical injury after his Bard Recovery IVC filter broke apart, causing a small metal “leg” from the device to travel to his heart. The metal fragment perforated his heart, necessitating open-heart surgery and a debilitating recovery period. The case was settled for an undisclosed amount.
Multiple lawsuits remain in federal and state courts including:
- Lessie Tillman – underwent unsuccessful attempt to recover Bard G2 IVC filter which had fractured and migrated to her renal vein, causing significant injury.
- Lisa Davis – injured after her Bard G2 filter fractured allowing a piece of it to lodge in the right ventricle of her heart. She declined open-heart surgery but continues to have heart issues and must take anticoagulant medication for life.
- Melissa Ebert – suffered injury and required surgery when her Bard G2 IVC filter detached and migrated to her pulmonary artery.
- Kelly Vlasvich – experienced cardiac tamponade (heart sac filled with blood) after metallic pieces of her G2 IVC filter broke off and traveled to the heart and lungs. The metal “spokes” were discovered after she went to the hospital complaining of chest pain, nausea, difficulty breathing and dizziness.
- Sarah Bednarek – injured when her Bard G2 IVC filter fractured and migrated, puncturing the Vena Cava and lodging in other organs resulting in long term disability.
Bard began receiving complaints regarding IVC filter device malfunctioning as early as 2004. Although the company knew about device failures, they did not disclose this information to the FDA or to the medical community but instead continued selling the devices.
Plaintiffs who have been injured by a faulty medical device may be eligible for actual damages (medical costs, lost wages, pain and suffering) and some may be eligible for punitive damages (to punish the company) if it can be proven that the manufacturer knew about defects in their products and continued to sell them anyway.
Most Bard IVC lawsuits have not been settled and many more may be expected.
What is an IVC Filter
An Inferior Vena Cava (IVC) filter is a medical device that is used to prevent blood clots from traveling to the lungs. IVC filters are implanted into the Vena Cava, the largest vein in the body, which transports “used” blood from the tissues and organs to the heart, where it is pumped to the lungs to be oxygenated and re-used. IVC filters are used in patients with certain clotting disorders like deep vein thrombosis (DVT) who cannot take anticoagulant medication. They are intended to “catch” blood clots before they reach the lungs and become a pulmonary embolism which can be fatal.
Bard, formerly known as C.R. Bard, is medical device manufacturer based in New Jersey, with an estimated annual revenue of about $3 billion. The company manufacturers a variety of medical devices for surgical, urological, and gynecological use. Bard currently manufacturers the G2 IVC filter which was intended to replace a prior device, the Recovery IVC filter after it was withdrawn from the market.
IVC filters were designed to protect patients from harm but unfortunately, several devices such as the Recovery and G2 IVC filters have not functioned as intended. The devices have been shown to cause serious complications due to defects.
In addition, though the FDA has stated that IVC filters should be removed as soon as the danger of blood clots has passed, many devices have been left in place for much longer and retrieval has proven difficult or impossible.
Hundreds of lawsuits have been filed against Bard regarding injury caused by the Recovery and G2 IVC filters. The manufacturer has also faced thousands of lawsuits for other faulty medical devices such as transvaginal mesh.
About Recovery IVC filter and G2 IVC filter
IVC filters are tiny “basket” or “cage” shaped devices constructed of metal which is designed to catch and retain blood clots until the body’s natural clot-busting system breaks it down. IVC filters were first used as permanent implants but later devices were designed to be removable.
Devices currently on the market are known as “retrievable” IVC filters but were initially approved for permanent placement. The FDA later approved them for removable use but many were never subjected to clinical trials before marketing due to a “shortcut” pathway known as the 510(k) process which allows for medical devices to be approved based on a similarity to a product already on the market.
The Bard Recovery IVC filter was introduced in 2003 but was discontinued and replaced by the Bard G2 IVC filter in 2005, apparently due to problems with the Recovery device. By 2010, the FDA had received 921 serious adverse event reports regarding IVC filters which had resulted in side effects or harm because of:
- Device migration – movement from original implant site
- Device embolism – detachment of device parts which travel to other organs
- Filter perforation and fracture
In 2010, the FDA issued an advisory warning, telling physicians that complications could be caused if retrievable devices were left in place too long and advised that implants be removed as soon as the risk of blood clots had passed.
Several studies published in multiple medical journals between 2010 and 2013, showed a high failure rate of several devices including the Bard Recovery and G2 IVC filters. Adverse events included venous wall puncture, venous thrombosis, pulmonary embolism and device removal failure. One of the studies showed that even though the devices were intended to be temporary, only 9 percent had actually been removed.
In May of 2014, the FDA issued an update to the previous advisory, stating that IVC filters should be removed within 29 to 54 days of implantation.
If an IVC device fails, it can cause a number of serious adverse events such as:
- Hemorrhage due to perforation of blood vessels, tissues and other organs
- Blood clot development
- Pulmonary embolism
- Severe pain
- Heart failure