Following a year-long investigation, an NBC Nightly News two-part report has raised significant questions about medical device manufacturer C.R. Bard, Inc.’s decision to continue to market and sell its inferior vena cava (IVC) filters, even after it became aware that its filters were failing and causing death and other serious injuries at higher rates than other similar devices.
The NBC report, titled “Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw?”, associated 27 deaths and 300 problems to failures associated with C.R. Bard, Inc.’s Recovery model IVC filters. The report also questioned why Bard did not recall the Recovery filters once a confidential study commissioned by Bard “urgently” urged further investigation of the device’s performance. Instead of informing the public about these problems or issuing a recall, Bard put profits over people, hiring a PR firm that circulated a crisis management plan warning about unfavorable press damaging Bard’s stock prices. A link to the NBC report is here:
http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536
The second part of the report, “Did Forged Signature Clear Way for Dangerous Blood-Clot Filter?”, raises serious questions about how Bard obtained FDA clearance for the Recovery filter. It details how the Recovery filter was originally rejected for FDA clearance, causing Bard to hire Kay Fuller, a veteran FDA specialist, to help Bard re-submit its FDA clearance application. After Bard failed to give her important performance safety test results, and following results from a small human clinical trial which raised red flags, Fuller grew concerned. Fuller told her boss she would not sign Bard’s FDA application until her concerns were addressed. Nevertheless, the report continues, her signature is on the FDA application. Fuller claims the signature on the application which was represented to be hers is not, in fact, hers, and was signed and submitted without her knowledge. A link to the second part of the report is here:
http://www.nbcnews.com/health/heart-health/did-forged-signature-clear-way-dangerous-medical-device-n417246
Cowper Law currently represents a number of individuals implanted with Bard IVC filters who have suffered injuries as a result. It is believed that over 20,000 people remain implanted with Bard Recovery filters, or the G2 model which replaced the Recovery. If you or a loved one have been injured as a result of being implanted with a Bard IVC filter, please contact Cowper Law at:
887.LAW.3707
We are here to fight for you.