Did Bard Forge An FDA Document Regarding IVC Filters?

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Did Bard Forge An FDA Document Regarding IVC Filters?
01.11.2016 News

There have been many questions regarding the use of inferior vena cava (IVC) filters manufactured by C.R. Bard in recent years. These filters are used to block blood clots in the lower body, to keep them from migrating to the heart and lungs. One of the key questions has to do with Bard’s actions with regard to getting the device cleared for market. Now, it seems that issues regarding a key element of that process may have been uncovered and it doesn’t look good for the company.

As part of a recent investigation by NBC News regarding the potential health risks posed by Bard IVC filters, questions were raised regarding the process Bard engaged in to clear their IVC filters for market. According to an insider who once worked for the company, back in 2002, after the Food and Drug Administration (FDA) had turned down one application for the device, Bard recruited regulation specialist Katy Fuller to help them gain the clearance they needed for their Recovery IVC filter.

Unfortunately for Bard, Fuller expressed major concerns about the Recovery IVC filter, especially after an extremely small human clinical trial raised some red flags in her mind. The company also refused to hand over the results of performance safety tests, which she also took as a serious red flag, as did the repeated admonitions by Bard officers to stop asking questions and be a team player. Finally, Fuller claims she refused to sign the FDA application until they resolved the issues she brought up to her satisfaction before resigning from the company and subsequently expressing her concerns to officials at the FDA.

Bard's IVC Filter May Have Gone To Market Fraudulently

Yet, Bard submitted their application to the FDA with what appears to be Fuller’s signature on it. During her on-screen interview, Fuller stated unequivocally that the signature that appeared on the application was not hers and a sample of her signature from roughly the same time period shows significant differences. The FDA has said that they take such accusations very seriously and they are looking into it. For their part, Bard calls any accusations of forgery "flatly untrue."

Every year, nearly 250,000 IVC filters are implanted. They are manufactured by eleven different companies, but based on statistics alone, Bard's product stands out as the most dangerous. After they received FDA clearance for the Recovery IVC filter, Bard sold Recovery filters to nearly 34,000 patients, resulting in at least 27 deaths that have been confirmed and a few hundred medical problems that were non-fatal.

Despite Safety Problems, Bard Refuses To Recall IVC Filters

Despite this record, Bard has still refused to issue a recall for its IVC filters.  Instead, the company hired a public relations firm to stem the tide of the bad press and keep their stock price healthy. They also reportedly hired a doctor from outside the company to perform a confidential study, who found that the Bard filters had a higher risk than those of competitors and suggested that the company conduct further investigation of the problems.

As lawsuits involving Bard IVC filters move forward, the question of whether or not a signature on an application C.R. Bard submitted to the FDA was forged will undoubtedly loom large. If Katy Fuller's signature was forged, then questions arise as to whether Bard officials knew their product was potentially dangerous when they put it on the market. Because the health and safety of our people is dependent upon the honesty and integrity of everyone in the medical field, including pharmaceutical companies, this is a very serious issue that should be looked into. It is unacceptable for any company to risk the health of patients to make a lot of money.