NBC News has an update on its year-long investigation of IVC filter manufacturer CR Bard.
- CR Bard replaced the Recovery filter with G2 version that it knew had potentially fatal defects soon after it was publicly available
- Bard’s Recovery IVC Filter, also had fatal flaws Bard was aware of, yet it remained on the market until they could release the G2
- In response to NBC’s original broadcast, Sen. Charles Grassley (R-Iowa), sent a letter questioning FDA’s role
An IVC Filter is intended to sit in the vena cava and block blood clots from making their way into the heart or lungs. The original Recovery device that was marketed by Bard had a very high failure rate as parts of the filter tended to break off and/or migrate and puncture veins, the heart, lungs and other vital organs, which can be fatal.
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. NBC’s investigation determined that this filter was associated with 27 deaths and around 300 non-fatal problems.
When Bard introduced the replacement G2 device the company became aware that the modified version had similar flaws shortly after it was released to the public. NBC obtained confidential Bard reports detailing the device’s failures within four months of its release. According to one internal memo, a Bard vice president asks why a different Bard filter on the market, one that had virtually no complaints wasn’t being used instead of the G2.
Bard did not recall the G2 series despite being seemingly aware of the potentially fatal danger to patients and instead marketed them for another 5 years, selling more than 160,000.
Sen. Charles Grassley (R-Iowa), chairman of the Senate Judiciary Committee, sent a letter to the FDA after viewing the NBC News report. His initial concern was with regard to actions the agency takes when new information about a cleared medical device becomes known. Sen. Grassley said that the FDA’s response was incomplete. This is not the first letter Sen. Grassley has written in reference to Bard and their recall process.
Both Internal Bard records and hundreds of FDA reports demonstrate that the G2 series did not solve the filter’s problems, according to NBC News.
These filters have been implanted into patients all over the country. On November 30, 2015, NBC news affiliate KSHB-TV reported on a Kansas City, MO victim of a Bard IVC filter
Fortunately, first large-scale, clinical research trial to evaluate the use of IVC filters was launched this spring with participation from seven manufacturers.
If you’ve had an IVC filter implanted and are unsure of the next step, please contact us at 888-586-7041. The Dysart Law Firm, PC is an experienced law firm practicing in the area of product liability for over 25 years. If you have had a blood clot filter implanted into your body, you may have a claim for money damages. Despite recommendations that they be used only for high-risk cases, approximately 250,000 IVC filters are implanted in patients each year, and as time passes, patients tend to forget that they have had this device implanted. It is critical to realize that IVC filters are not intended to be permanently implanted. Call us today to discuss your options.
You can read more about last fall’s investigation of CR Bard’s Recovery IVC Filter by NBC News here.
