Pharmaceutical

News report questions what Bard knew of its IVC filter defects

IVC filter Wikimedia by BozMo 336x210 News report questions what Bard knew of its IVC filter defectsQuestions are being raised about how much medical device company C.R. Bard knew about health risks associated with its Recovery inferior vena cava (IVC) filter, which has been linked to several deaths and non-fatal injuries.

Retrievable IVC filters are spider-like wire devices that are implanted in the vena cava, the body’s largest vein, to stop blood clots from reaching the heart and lungs. The filters are used in patients who cannot tolerate blood thinners.

Bard is one of 11 manufacturers of the device, which also include Johnson & Johnson and Cook Medical. Retrievable IFC filters were introduced in 2003 and have been promoted for use in patients undergoing bariatric surgery, trauma surgery and orthopedic surgery. The devices have been linked to serious complications including migration, fracture and perforation leading to embolism, organ damage and death.

An NBC News investigation focused in on Bard’s Recovery device, which has been linked to at least 27 deaths and 300 non-fatal injuries. In the past decade, as adverse event reports began adding up, Bard opted not to recall the Recovery device, but to hire a public relations company to offset negative press and help push sales. Another 34,000 were sold over the next three years before the company replaced the Recovery with a modified version, called the G2.

In a statement to NBC News, Bard refused blame, saying the device had been “appropriately cleared” by the FDA and has demonstrated a “significant benefit to patients.” That regulatory clearance, however, took more than one attempt. After an initial rejection from the FDA, Bard hired Kay Fuller, a regulatory specialist, in 2002 to help obtain FDA approval.

Fuller told NBC News that she raised questions about how Bard had handled its application to the FDA. She said the company never gave her important safety performance data, and that a small clinical trial testing the device raised serious red flags. “I was pretty concerned there were going to be problems with this product,” she told NBC News.

Yet, when Fuller told the company that she was concerned about the safety of the Recovery Retrievable IVC filter, she says she was informed that she would be removed from the team if she continued to raise red flags. “I was shocked,” she told NBC News. When questioned why she still signed the application for the device, which ultimately led to its approval, Fuller adamantly said it was not her signature.

Fuller would not say if the company had forged her name on the document, but simply, “I will tell you I did not sign it.”

Even more damning is a confidential study that Bard reportedly commissioned an outside doctor to conduct on the Recovery filter. That study was obtained by NBC News. It shows that Bard’s Recovery Retrievable IVC filter had higher rates of relative death risk, filter fracture and movement than all its competitors. The doctor concluded that “further investigation… is urgently warranted.”

Sources:
Medical Device & Diagnostics Industry
NBC News
NBC News