Claimants who received Bard IVC filters filed three class-action lawsuits against Bard in Florida, Pennsylvania and California courts. The lawsuits argue plaintiffs with Bard Recovery, G2 and G2 Express filters that had not fractured or migrated must receive medical monitoring because of Bard’s negligence, misrepresentation and concealment of data. The plaintiffs claim everyone who had one of the devices implanted in them make up a class which should be compensated for medical monitoring expenses. Courts have not approved the formation of a class yet. Plaintiffs filed the first lawsuits against Bard in California and Pennsylvania state courts in 2012. The majority of cases are mass tort claims – individual lawsuits filed in federal MDL courts. In October 2014, the US Judicial Panel on MDL consolidated lawsuits against Cook from 11 districts into an MDL in the Southern District of Indiana. In August 2015, the US Judicial Panel on MDL consolidated lawsuits against C.R. Bard to the US District Court – District of Arizona.
Patients may bring product liability (defective device) claims, negligence claims, as well as wrongful death claims, if applicable.
There were numerous studies that came out after the release of these implants that demonstrated failures and did not prove the efficacy of the products. In 2010, the U.S. FDA announced a safety alert regarding retrievable IVC filters. The FDA received 921 reports of adverse events from 2005-2010.
Plaintiffs filed the first lawsuits against Bard in California and Pennsylvania state courts in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) consolidated lawsuits against Cook from 11 districts to an MDL in the Southern District of Indiana. The number of lawsuits against Cook has dramatically increased. The U.S. Judicial Panel on MDL consolidated lawsuits against Bard to the U.S. District Court District of Arizona in August 2015. Thousands of lawsuits are pending in the MDL.
Lisa Davis sued Bard after a G2 filter implanted in 2006 fractured and migrated to her heart in 2008, causing ongoing heart issues. Davis declined to have open heart surgery to remove the fragment and must take blood thinners for the rest of her life. She claims Bard failed to warn her physician of the G2’s risks and misrepresented the device as safe. She sued for physical trauma, anxiety and impaired ability to earn wages.
Although the filters were designed to prevent life-threatening pulmonary embolisms (PEs) – blood clots in the lungs –, they can have life-threatening side effects, including but not limited to organ perforations, embolisms and death. In a report released in 2010, the FDA received more than 900 reports of adverse events associated with IVC filters.
In 2010, the FDA warned the retrievable filters posed risks of filter fracture, device migration and organ perforation and should be removed as soon as the patient’s risk for blood clots subsided. The FDA updated safety communication in 2014, stating most devices should be removed between the 29th and 54th day after implantation. But the warning signs came too late for some.
IVC filters are associated with potential risks, like damaging veins and failing to stop blood clots from bypassing the device. Any procedure involving the placement of a catheter inside a blood vessel carries certain risks. Those risks include damage to the blood vessel, bruising or bleeding at the puncture site, infection and allergic reaction. The IVC filter could migrate, penetrate through the vein, break loose or become scarred to the vein and cannot be removed.
The device is tailored towards patients with certain medical conditions, so there is not an age or gender that more commonly uses the implant.
The device was introduced in 1979 and its use has increased continuously through the years. The devices that are part of the litigation that our firm is working on were implanted in 2002 and later.
