NBC Accuses CR Bard of Knowingly Selling Unsafe Device

CR Bard's G2 blood clot filter was meant to replace the troubled Recovery filter. NBC News now claims the device company continued to sell the G2 even after its officials were aware it could also fail.

Qmed Staff

CR Bard officials knew early on that their successor to the troubled Recovery blood clot filter was faulty, too, but they nevertheless continued selling it for years even as patients died and many more were injured, according yet another damning NBC News investigation related to the company and its blood filter products.

CR Bard received FDA clearance in 2005 for its G2 filter. The G2 replaced CR Bard's Recovery filter, which NBC says was involved in 27 deaths and 300 injuries over a 10-year period. Although the Recovery device was not officially recalled, the company stopped selling it amidst complaints that it had a high failure rate.

The successor product, the G2, had similar problems, NBC alleges. But four months after the G2's clearance, CR Bard officials were concerned that the G2 filter series could also fail, the network says, citing internal CR Bard documents it obtained.

After discovering the failure risk of the redesigned G2 device and the related G2 Express product, the company continued selling the product for five years, ultimately selling 160,000 of the devices. Twelve patients treated with the G2 and the G2 Express died, and hundreds of others were injured, according to NBC, which pegs the statistic on CR Bard and FDA documents.

A 2010 study in the Archives of Internal Medicine by William Nicholson, MD involving 80 patients found that 13 of 80 patients receiving the G2 had problems with the struts of their devices fracturing. The rate was higher with the Recovery device -- 7 of 28 patients had problems with their filters fracturing or embolizing. One of the patients died.

Bard in a statement told NBC that it stood by the "safety and efficacy of these devices when used as instructed."

The report comes about four months after an NBC report in which a former C.R. Bard regulatory affairs specialist said she did not know how her signature ended up on an FDA application for the Recovery filter, which she thought was problematic.  "That's not my signature," Kay Fuller told NBC News after being shown a copy of the paperwork.

An FDA spokesperson declined to comment regarding the forgery allegation.

Now it has come to light that internal CR Bard documents indicate that the company was concerned that the Recovery's successor was unsafe. An email from David Ciavarella, staff vice president, corporate clinical affairs, states: "[W]e also have [the SNF vena cava filter) that has virtually no complaints associated with it. Why shouldn't doctors be using that one rather than the G2?

In 2004, CR Bard had enlisted public relations firm Hill & Knowlton to assist with a crisis communications plan related to the Recovery device.

FDA has issued safety communications, one in 2010 and an update in 2014, advising the public of problems observed with IVC filters, including device migration, filter fracture, embolization, perforation of the IVC, and difficulty removing the device. FDA has recommended that physicians consider removing implanted filters in some patients, and has required filter manufacturers to engage in additional post-market surveillance.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

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