Bard Downplayed Risks, May Have Caused Deaths

In order to get FDA approval, C.R. Bard may have downplayed the risk associated with its Recovery blood clot filter, resulting in nearly 30 deaths and hundreds of non-fatal injuries, according to a year long investigation from NBC News resulting in a shocking and scary two part story.

The Recovery filter is implanted into a patient’s inferior vena cava, the body’s largest vein, in order to keep blood clots from entering the heart or lungs. However, the Recovery filter can break, embedding pieces into major organs. According to the NBC News investigation, the signature of a C.R. Bard employee may have been forged on a document sent to the U.S. Food and Drug Administration (FDA) to help gain approval for the company’s Recovery IVC filter.

According to the report, Bard hired veteran regulatory specialist Kay Fuller in 2002 to help the company gain FDA clearance for the Recovery filter after a previous effort proved unsuccessful. However, in an interview, Fuller said she began to have significant concerns about the Recovery filter. She stated she was concerned about the results of a human clinical trial as well as the fact that the company failed to provide results of a separate safety performance test.

Fuller told NBC that Bard officials suggested she would no longer be a part of the team if she voiced those concerns. She also stated in the interview that she informed her boss she would not sign the FDA application unless her concerns were resolved. However, according to the report, Bard submitted the application with what appeared to be Fuller’s signature.

Fuller clearly stated that signature was not hers, but would not say it was forged. NBC compared the signature on the application with a sample of Fuller’s signature at the time and they were substantially different. Fuller resigned from Bard after reporting her concerns regarding the safety of the Recovery filter to the FDA. The agency declined NBC’s request for an interview, as did Bard executives. However, in a statement sent to NBC, the company said that any suggestion Bard submitted a forged application to the FDA was “flatly untrue.”

According to part one of the NBC Nightly News story, C.R. Bard continued to sell 34,000 Recovery filters for three years despite mounting reports of death and injury linked to the IVC filter.  Instead of removing the reportedly dangerous device from the market, the company instead simply modified the Recovery filter and gave it a new name; the new model was labeled the G2 filter. NBC News reported that, according to confidential Bard records obtained by the news organization, the Recovery filter is still implanted in about 20,000 people.

According to John Dalimonte and Teresa Toriseva, lawyers who have successfully recovered compensation for people who have been victimized by these defective IVC filter devices for over five years, in July 13, 2015 the FDA 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.

Lawyers are lining up to take cases related to these products, Dalimonte and Toriseva 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.

There are at least 22 Bard IVC Filter cases currently being heard in federal court, though the U.S. Judicial Panel on Multidistrict Litigation (JPML) states they are aware of 16 additional, related cases pending in 13 different U.S. District Courts.

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lindseyLindsey McCoy MPA, is an Executive Medical Recruiter and former Executive Director in the not for profit sector.

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