NBC Investigation Reveals Life-Threatening Issues with Bard IVC FilterSep 9, 2015
A year-long investigation by NBC's "Nightly News" raises questions about use of C.R. Bard's Inferior Vena Cava (IVC) filter, which is used to prevent blood clots from reaching the heart. Industry statistics indicate that the device is implanted in about 250,000 Americans each year. According to NBC, C.R. Bard was aware that the device was associated with serious and sometimes fatal complications, but continued to sell the Bard IVC filter nonetheless.
NBC reports that Bard's IVC Recovery filter has been associated with 27 deaths and over 300 injuries as of September 2015. The device is reportedly subject to migrating, fracturing, perforating, and causing blood clots, rather than preventing them. Additionally, there may be issues associated with the Bard IVC cleaning processes, as the methods were allegedly never validated. C.R. Bard has been issued a warning from the U.S. Food and Drug Administration (FDA). Allegedly, Bard failed to report customer complaints involving injuries and deaths.
According to the FDA warning letter, violations were cited at two facilities: One facility located in Tempe, Arizona and the other in Queensbury, New York. So-called Inspectional Observations took place from November 18, 2014 through January 5, 2015 in Arizona and from October 6, 2014 through November 25, 2015 in New York. The FDA cited the Arizona facility for manufacturing the Recovery Cone Removal System without marketing clearance or approval. This means that the system is an adulterated product. Bard is also accused of failing to report a device malfunction that could likely result in serious injury or death. Additionally, the FDA letter indicated Bard misfiled several customer complaints, including the report of one patient's death. At the Queensbury, New York facility, Bard was cited for failing to validate a procedure used to clean the IVC filters.
In its two-part investigative series entitled "Serious questions are being raised about a medical device implanted in thousands of Americans at risk for blood clots—including whether the manufacturer told all it knew about potentially fatal flaws," NBC revealed that one patient, who was implanted with the Recovery filter after a car accident, nearly died when a piece of the filter broke off and pierced the patient’s heart. "The filter was supposed to stop them from reaching her heart or lungs; instead, it nearly killed her," the investigation found. The probe also revealed the case of a 55-year old woman who died after being implanted with an IVC after following a brain aneurysm. An autopsy indicated found that a fragment of the Bard IVC Filter entered the woman’s heart via a blood clot. The clot, which surrounded a piece of the filter, entered her heart; the foreign piece, in turn, punctured her heart.
C.R. Bard knew of the risks, and took "defensive measures" in response, NBC reports. The company hired a public relations firm and commissioned a secret study, which revealed a higher rate of death, device fraction, and migration compared to other IVC filters.
Bard is also accused of forging a specialist's signature in order to gain approval for the Recovery IVC filter. Initially, the FDA rejected the application for the device. After this, Bard recruited veteran regulatory specialist, Kay Fuller, in 2002. Fuller told NBC that she found issues with the device early on and would not sign an FDA application. Despite this, she says her signature "appears to have been forged on the paperwork."
Bard IVC Filter Lawsuits Centralized to MDL
As of November 2015, more than 50 lawsuits have been centralized to a newly created multidistrict litigation (MDL) in Arizona. According to a United States Judicial Panel on Multidistrict Litigation Transfer Order dated August 17, 2015, the Honorable David G. Campbell is presiding over In Re: Bard IVC Filters Products Liability Litigation (MDL No. 2641).
Lawsuits filed over Bard's retrievable IVC filters contain similar allegations that the IVC filter devices were defectively designed and prone to fracture, migration, tilt, or perforation of the inferior vena cava. The human body has two vena cavas. A vena cava is a large vein that carries deoxygenated blood into the heart. The inferior vena cava is responsible for carrying blood from the lower body into the heart.
Centralizing lawsuits that have similar allegations to one court before one judge makes complex litigation more efficient because it eliminates duplicate discovery and avoids inconsistent pretrial rulings.
| Legal Help for Victims of Bard IVC Filter System Injuries
Our Bard IVC Filter System injury lawyers know how awful complications from a fractured Recovery IVC Filter or G2 IVC Filter System can be. We will do everything legally possible to make sure the victims of these defective devices are fully compensated for their injuries.
If you or someone you know was injured as a result of a defective Recovery IVC Filter, you have valuable legal rights. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with a qualified Bard IVC Filter System injury lawyer.