The spouse of a deceased man filed a lawsuit against C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. alleging that the plaintiff suffered damages including her spouse’s wrongful death due to the defendant’s implantation of a malfunctioned inferior vena cava filter, or IVC filter.

The plaintiff alleges that Ronald T. was implanted with a “defective and unreasonably dangerous” IVC filter medical device manufactured by Bard known as the Denali vena cava filter.

The plaintiff seeks damages lost including and not limited to: disability, impairment, scarring, emotional and psychological trauma, loss of consortium, diminished capacity, lost wages, and loss of earning capacity.

The defendant, C.R. Bard, headquartered in New Jersey, is a leading manufacturer and multinational developer of medical technologies in the fields of oncology, vascular, and urology specialties. Bard Peripheral Vascular Inc. is a subsidiary of C.R. Bard, Inc., with its principal state of business located in Arizona.

An IVC filter is a medical device that is used primarily to capture blood clots that travel from the body’s lower extremity upwards towards the heart and lungs. The medical device is used to inhibit the risks of developing a condition called deep vein thrombosis, or DVT, and pulmonary embolism, or PE. Blood clots developed in the body’s lower extremity are called DVT, while a blood clot developed in the lungs is called a PE.

According to the Denali vena cava filter lawsuit, this IVC filter has been on the market for years. However, the lawsuit states that although Bard was the first manufacturer of the medical device to obtain FDA clearance to market the IVC filter in 2003, this “clearance” was obtained without “adequate testimony on the safety and efficacy of the new line of devices.”

The Denali vena cava filter lawsuit further details an article published in the Annals of Surgery. According to the lawsuit and the article published, “patients inserted with IVC filters concluded that IVC filters were not effective in preventing pulmonary emboli and instead actually caused thrombi to occur.”

The study compared results of over 30,000 trauma patients. According to the study, twice the percentage of patients who had the IVC filter medical device inserted died in comparison to patients who had not had the IVC filter implanted. Moreover, five times the number of patients implanted with the IVC filter medical device developed deep vein thrombosis, and four times the relative percentage of patients who had had the IVC filter implanted developed thromboemboli.

The study, as referenced in the lawsuit, also reported that “over twice the percentage of patients developed a pulmonary embolus- the very condition Bard told the FDA, physicians, and the public that its IVC Filters were designed to prevent.”

According to the Denali vena cava filter lawsuit, the study concluded that the results show “without any question that IVC filters are not only utterly ineffective but that they are themselves a health hazard.”

The Denali Vena Cava Filter Lawsuit is Case No. 2:15-md-02641-DGC, in the U.S. District Court for the District of Arizona.