FDA ISSUES WARNING TO C.R. BARD FOR VIOLATIONS OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT IN CONNECTION WITH THEIR IVC FILTERS
July 13, 2015
The FDA recently issued a warning letter to C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively referred to as "Bard") for eight violations of federal law relating to the safety of its Inferior Vena Cava (IVC) filter product line. These violations concern safety of the use the Recovery Filter, G2 Filter, G2X Filter, G2 Express Filter, Eclipse, Meridian Filter and Denali Filter were sold and implanted in individuals as retrievable filters who had a temporary need to prevent a blood clot from travelling to the heart or lung. Among the number of violations, Bard illegally sold adulterated and misbranded IVC Filters and failing to report complications and adverse events. The letter further cites Bard with violations for withholding critical information from the FDA and public.
On August 9, 2010, the FDA issued an advisory to physicians that these retrievable filters be removed after the clot burden passed and reissued its advisory on May 6, 2014 because of increased numbers of adverse events associated with the use of removable IVC filters. However, the FDA never cleared the Recovery Cone Removal System, Model RC-15 in violation of 21 U.S.C. § 321(h). Bard illegally sold this device to doctors without their knowledge that it was not cleared because Bard had no other device to remove these filters and wanted to keep their competitive edge.
The FDA further found that Bard violated 21 U.S.C. § 820.198(a) for its complaint handling procedures, investigations and reporting G2 Filter embolization of a detached filter arm with associated areas of hemorrhage and necrosis in the lung and death; G2 Express Filter broken filter and surgical intervention; G2 Filter detached Filter limb in renal vein with IVC wall perforation; Eclipse Filter with detached filter limb that migrated to heart; Denali Filter that had a detached filter arm embedded in the IVC wall and many other serious injuries. The FDA further cited Bard with violations for at least 10 other cases where Bard failed to report patients who had unsuccessful retrieval surgical procedures.
Additional FDA investigation found Bard in violation of 21 U.S.C. § 803.50(a)(2) for failure to submit a report to the FDA after Bard became aware of information, from any source, that reasonably suggests that its IVC filter devices malfunctioned and that these devices it markets would likely cause or contribute to death or serious injury if the malfunction were to recur.
Bard was further found to have inadequate testing procedures to determine whether during the manufacturing process that the chemical cleaning process for the Eclipse and Denali Filters were safe. The FDA further found that the Denali Filter failed to meet its own predefined acceptance criteria for function. Bard was also in violation of 21 U.S.C. § 820.80(b) for failing to establish and maintain procedures to inspect, test or otherwise verify incoming product as conforming to specified requirements.
John Dalimonte and Teresa Toriseva have successfully recovered compensation for people who have been victimized by these defective IVC filter devices for over five years. They represent individuals who have been planted with the Bard Recovery Filter, G2 Filter, G2X Filter, G2 Express Filter, Eclipse, Meridian Filter and Denali Filter. They also represent individuals implanted with defective Cook Medical IVC filters and are members of the executive committee prosecuting Cook Medical in the federal consolidation action.