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Scandal Hits Dangerous Medical Device Maker Bard – Again

Posted by Rob Jenner on September 25, 2015 in Consumer Alerts

Scandal Hits Dangerous Medical Device Maker Bard – AgainBard, formerly known as C.R. Bard, has been accused – again – of knowingly selling a defective and unreasonably dangerous medical device. Bard is a familiar foe to us; we most recently fought them on behalf of women maimed by Bard’s defective vaginal mesh products.

This time the allegations involve the company’s Recovery IVC (inferior vena cava) Filter, a device meant to catch potential blood clots after surgery in people who can’t use other blood clot prevention techniques. Dozens of lawsuits across the country claim the device fragmented inside a patient’s body, resulting in death or serious injury. The FDA has confirmed that Bard’s Recovery filter has been linked to 30 deaths and some 300 injuries since it first came on the market.

Bard’s Consultant’s Signature Forged on Key Documents?

But a recent NBC Nightly News investigation has added a disturbing—even shocking—new component to the claims against Bard. In an interview, a respected regulatory consultant says her signature was forged on documents necessary for the company to gain FDA approval for the filters. If this is true, the company faces criminal fraud charges. As it should.

According to the two-part NBC story, Kay Fuller was hired by Bard in 2002 to help the company obtain FDA approval to market the filter. With 20 years of technical, medical, and regulatory experience under her belt, she had the credentials to look at the device’s clinical trial data, ask questions, and make recommendations. Fuller told Bard she had concerns about the Recovery filter’s safety and would not sign off on required documents unless the company answered more questions and provided safety testing information that she’d been denied. Bard refused. Fuller resigned her position in 2003 after reporting her concerns about the Recovery filter to the FDA. Mysteriously, her signature later appeared on documents sent to the FDA that resulted in agency approval.

In the story, NBC compared Fuller’s signature from 2002 to the signature that appears on the FDA documents. They looked substantially different.

Bard Has Paid for Injury and Fraud Allegations Before

On August 4, 2015, news surfaced that Bard had agreed to pay more than $200 million to settle at least 3,000 cases by women injured by the company’s vaginal mesh inserts. Thousands more of these lawsuits, which claim Bard and others failed to adequately safety test their implanted mesh products on women, have yet to be resolved. We currently represent many women who were maimed by these products and who deserve to be compensated.

In 2013, Bard paid $48.26 Million to resolve allegations by the Justice Department that the company had given illegal kickbacks to doctors to get them to use and promote one of their cancer products, the cost of which was covered substantially by Medicare with our tax dollars.

IVC Filter Claims Add to Stink that Surrounds Bard

The most recent allegations involving a Bard product sound and smell a lot like past allegations. If it indeed is proven that company officials knowingly forged documents to get their unsafe product approved by the FDA, they should go to jail. The company, which has a market value right now of more than $14 billion, also should be slapped with a fine so big that it finally learns that integrity is more profitable than deceit.

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