Earlier this week, a two part news report aired on NBC Nightly News. This Inferior Vena Cava filter (IVC) investigation addresses the more than one million devices that have caused deaths and severe personal injuries.
NBC News reports the IVC Filter was designed to help save lives, but has instead become a killer as this device was implanted and thought to be safe.
The news report focused its attention on one of the best selling IVC fiters, the Bard Recovery device, manufactured by C.R. Bard a giant medical device manufacturer.
The Recovery filter, is a one-and-a-half-inch metal like trap, designed to be implanted inside a major vein, the vena cava, and block blood clots from traveling to the heart or lungs, where they could be deadly.
Now, questions are being raised about the IVC Filter device implanted in thousands of Americans at risk for blood clots — including whether the manufacturer told all it knew about potentially fatal flaws.
Are Bard Recovery Filters Responsible for Death?
According to the NBC News investigation, at least 27 deaths have been associated with the Bard Recovery filter — a spider-shaped metal device over the past 10 years.
FDA data reveals that approximately 300 other non-fatal problems have also been reported with the Recovery device.
Damning Bard Internal Public Relations Report
After the problems with the Recovery began, Bard hired public-relations giant Hill and Knowlton. The firm prepared a crisis management plan to Bard management, warning that “unfavorable press” could damage stock prices and ruin reputations. The company also retained an outside doctor expert to conduct a confidential study.
The consultant found the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all its competitors.
“Further investigation…is urgently warranted,” the doctor wrote.
As death and injury reports were escalating, the company decided not to recall the Recovery device. Bard dismissed the death and injury reports and continued to sell about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.
FDA Clearance of the Bard Recovery Device
Getting FDA clearance took more than one attempt. The agency rejected one application for the Recovery device. In 2002, the medical giant C.R. Bard recruited Kay Fuller, a veteran regulatory specialist, to help secure FDA clearance for its Recovery blood clot filter.
Company Insider Signature “Forged”
According to Fuller, the company did not give her important safety performance test results and that a small clinical trial raised red flags. “I was pretty concerned there were going to be problems with this product,” she said.
Fuller then resigned, and the company went ahead and submitted its application for the device to the FDA. The application apparently has Fuller signature on it.
“I will tell you I did not sign it,” Fuller said, adding that her name was signed on the application without her knowledge.
Fuller after she resigned from Bard, reported her safety concerns to the FDA. “I never knew what they did after that,” she said. The FDA refused an on-air interview with the investigative news team.
As of 2009, Bard’s own confidential records estimated there were more than 20,000 people still walking around with them.
Bard IVC Filter Claims Centralized and Consolidated in Arizona
The U.S. Judicial Panel on Multidistrict Litigation (JPML), ordered all filed Bard Inferior Vena Cava filter injury, perforation and migration lawsuits, to be consolidated and centralized before one federal judge in Phoenix, Arizona for coordinated pretrial proceedings.
Existing cases pending throughout the federal court system will be transferred to U.S. District Judge David G. Campbell, who will oversee the multidistrict litigation (MDL) proceedings. Bard Peripheral Vascular is the manufacturer of these Bard IVC filters and is headquartered in Phoenix, Arizona.
This consolidation and centralization of Bard IVC filter cases only applies to cases filed in the federal court system. There are less than 50 filed Bard Recovery filter and Bard G2 filter lawsuits currently pending in U.S. District Courts nationwide.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.