Bard Recovery IVC Filter: How Many Fatalities Must Occur Before a Mandatory Recall?

How many fatalities, or near fatalities, need to occur before a medical product manufacturer takes the faulty product off the market? Apparently no benchmark has been put to the test, as is the case with C.R. Bard’s Recovery inferior vena cava (IVC) filter. The device, implanted in patients who are at risk for blood clots, is now associated with at least 27 deaths over a 10-year period, leading to many lawsuits.

Apparently the device’s most fatal flaw is a faulty filter that fractures and migrates to other parts of the body. This can cause huge complications, such as punctured organs. And, this isn’t its only problem. Hundreds of other non-life threatening troubles have been reported about the ill-fated Recovery Filter.

To date, the medical device manufacturer has hired a top PR firm to minimize unfavorable press, as well as an outside physician to conduct a confidential study. Although I’m unsure as to how successful the PR firm has been with the bad press, the doctor hired to conduct a study has spoken. Apparently, the research confirms that the Recovery Filter had higher rates of relative risk for death, filter fracture, and movement than any of its 10 competitors. Needless to say, further investigation of the Filter was encouraged in the study’s conclusions.

But, the real crime here is that I still haven’t even written the word “recall.” Bard sold approximately 34,000 Recovery Filters over a three-year period before finally replacing the device with a modified version called the G2. But, this replacement filter has posed the same problems. Furthermore, it doesn’t address the fact that tens of thousands of the faulty devices are still “out there.”

Why no repercussions? Why, at least, has there been no hand slapping by the FDA? Bard says it’s because the FDA has “appropriately” cleared all of its filters. Yet, even this statement has a back-story. Apparently FDA clearance required more than one attempt. After the first application was rejected in 2002, a veteran regulatory specialist, Kay Fuller, was brought in to reapply for the clearance. In an NBC interview with Fuller, she commented that the company failed to give her important safety performance test results, information that she knew would have raised problems for Bard. However, Fuller was told she’d be removed from the process if she pursued the matter any further.

We can only hope that concern about public safety trumps concern about Bard’s negative PR. We call on the FDA to make sure the Bard Recovery IVC filter is pulled from the market, so no one else is at risk of sustaining a life-threatening injury.