Recently in September, a wrong death lawsuit was filed against C.R. Bard by Catherine Rowden, over its allegedly defective Bard G2 inferior vena cava (IVC) filter.
The lawsuit was filed on September 28, in the U.S. District Court for the Eastern District of Missouri, over the death of Johnny Rowden, her deceased husband.
Critical Facts Alleged In The Lawsuit
According to the product liability and personal injury lawsuit, Johnny Rowden had the Bard G2 retrievable filter placed in his vena cava in November 2006, to trap blood clots that travel from the deep veins and prevent them from causing a pulmonary embolism or a blood clot to the lung.
Rowden alleges that the Bard G2 filter failed after it was implanted, by tilting out of position and perforating or puncturing the vein. The filter device was rendered useless at stopping a fatal clot from moving to the heart or lungs, with catastrophic results.
Potentially Thousands Of IVC Filter Injury Claims
By some estimates, over 30,000 retrievable filters have been implanted over the past 10 years, which are all susceptible to catastrophic and sudden failure. The exact number, is however unknown, since there is no national medical device registry in the United States, unlike our European counterparts and health agencies.
Several hundred IVC filter lawsuits have been filed on behalf of patients across the U.S., who developed similar deadly injuries.
The lawsuits share similar allegations, that serious design problems with the Bard G2 and other retrievable filters make them susceptible to tilt out of position, migrate, fracture/embolize or eventually fail to prevent heart or pulmonary blood clots.
What is the Bard IVC Filter?
The IVC filter device is made of metal and is designed to trap trap blood clots that travel from the deep veins and prevent them from causing a pulmonary embolism or a blood clot to the lung. The G2 filter is the second generation or newer version of the Bard Recovery filter. The original Bard Recovery filter was plagued with fracturing, perforation and migration and had a very high failure rate.
According to to Rowden, Bard knew the IVC filter design was defective, knew of filter fractures and migration reports, but ignored them and continued selling the dangerous devices.
Finally Bard made some minor cosmetic changes and repackaged the dangerous and defective device as the G2 filter.
NBC News Damning Investigation
According to a blistering investigative report by NBC news, C.R. Bard was warned about the problems by adverse event reports and their own employees, but continued to sell the devices, without warning the doctors of the defects and injuries.
Bard’s Own Expert Quits the Company
One Bard expert, Kay Fuller, a FDA regulatory specialist, said she quit when the company would not address her concerns over the device’s health issues, and the company then forged her signature on the FDA approval application.
FDA Warnings
The FDA issued a warning in August 2010, about the risk of retrievable filter injuries, noting that the agency had received thousands of adverse event reports.
In May 2014, the FDA issued strong warnings to doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has lessened.
Bard Federal Multidistrict Litigation Set in Arizona
The U.S. Judicial Panel on Multidistrict Litigation approved consolidated federal proceedings for Bard IVC filter lawsuits.
The Bard IVC injury claims are centralized before U.S. District Judge David G. Campbell in the District of Arizona as part of a MDL, or multidistrict litigation.
Cook Federal Multidistrict Litigation Set in Indiana
Cook Medical is another major manufacturer of these retrievable IVC filters and is also plagued by similar design flaws and injury patterns.
Consolidated MDL proceedings has been set for all Cook Medical IVC filter lawsuits, the Cook Celect and Gunther Tulip filters. These cases are centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) 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.
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