Bard’s IVC Filters: Troubling, possibly fraudulent activities may have put lives at risk

This fall, NBC News completed a year-long investigation of medical device manufacturer CR Bard’s Recovery IVC filter.  

• IVC Filters intended to be temporary, not permanent
• Bard is the subject of many IVC lawsuits
• 250,000 IVC filters are implanted in patients each year
• The number of fatalities and complications are growing

This device is designed to sit in the vena cava and block blood clots from making their way into the heart or lungs.  The Recovery device has a very high failure rate; parts of the filter tend to break off and puncture the patients’ veins, or migrate to the heart, lungs and other vital organs, which can be fatal.   NBC’s investigation determined that this filter was associated with 27 deaths and several hundred non-fatal problems.

The NBC report also suggests that Bard allegedly forged the signature of a regulatory specialist on an application for FDA approval after their initial application was rejected.

After the problems with the Recovery began, Bard hired a public relations firm and sent a plan to  upper level executives warning of damaged stock prices and ruined reputations.  The NBC News report found evidence that Bard executives were fully aware of the dangers to patients  as far back as 2004.   Bard’s own internal research results linked the Recovery device to higher fatality rates than all of their competitors. The author of the internal Bard study wrote that “further investigation…was urgently warranted.” Instead of issuing a recall or advisory, Bard sold over 34,000 more units.

Bard is currently the subject of many lawsuits involving their IVC filters. In fact,  Bard recently received yet another warning letter this summer.

While Bard was the subject of NBC’s investigation, there is much controversy regarding IVC filters.   A smaller, local NBC news affiliate in Florida released this report just a month ago.

There are likely financial incentives to bring these devices to market, as the United States remains the largest medical device market in the world with a market size of around $110 billion, and it is expected to reach $133 billion by 2016.  The IVC filter market alone is worth $190 million and is is projected to reach $435 million globally by 2016.

Unless there is an absolutely critical necessity to implant an IVC filter, for now, it might not be likely that the risks outweigh the rewards.  “There is little medical evidence that this device does what it is assumed to do, which is prevent PE and save lives,” said Richard White, chief of general medicine at UC Davis, in 2013.  “If we cannot administer a blood-thinning anticoagulant, it may seem logical to use one of these filter devices,” said White. “The problem is that there isn’t any solid proof that this option actually benefits patients. There is also distressing evidence that the majority of the devices are left inside patients and never removed. Over months and years, the device can break apart and become harmful.”