A new patient joins a multidistrict blood clot filter lawsuit claiming Bard’s IVC filter causes clots instead of preventing them, as intended and advertised. Patients claim that the company released the device into the market without sufficiently assessing the product’s risk to human health.

Plaintiff Cynthia E. claims that she was implanted with the Bard G2 Vena Cava Filter on November 21, 2008, and suffered injury as a result of the device’s allegedly defective design. In her blood clot filter lawsuit, she makes some of the claims brought forward in a growing multidistrict litigation against Bard, alleging that they sold consumers a dangerous and defective device.

Cynthia aims to hold Bard liable for her injury, as well as liable for manufacturing and information defects related to the product (failure to warn).

She claims that Bard was negligent in researching the device’s possible dangers, in designing and manufacturing the product, and in failing to warn consumers about product risks. She also holds them responsible for misrepresenting the product and concealing its dangerous defects, and failing to recall the product in light of consumer claims that it was defective. 

Blood Clot Filters

According to the blood clot filter lawsuit, Bard initially developed a range of IVC filters (inferior vena cava) filters designed to catch blood clots that travel from the lower portions of a patient’s body to their heart and lungs. Allegedly, this prevents the clots from traveling through the body, causing serious health problems like stroke and pulmonary embolism.

IVC filters have been on the market for decades, but were initially were permanent implants, and used primarily in patients who were undergoing anticoagulation therapy. The blood clot filter lawsuit states that, allegedly, Bard attempted to increase sales of IVC filters by promoting prophylactic use of the filters among “nontraditional” patient populations who were under a temporary risk of developing blood clots, like the elderly, trauma patients, cancer patients, and orthopedic patients.

The IVC blood clot filter lawsuit goes on to claim that Bard responded to physician’s desire for an IVC filter that could be removed once a patient’s risk for blood clots had reduced. Bard reportedly was the first company to release such a filter, receiving FDA approval for a retrievable filter in July 2003.

However, this device was allegedly released with insufficient testing of the device, and without the company having sufficiently established that it was safe for human use. The lawsuit claims that the company had failed to even establish that the device was effective in its purpose of preventing pulmonary embolism.

According to the IVC blood clot filter lawsuit, the device was “plagued with problems” since its release, and numerous patients reported adverse effects. In fact, the IVC multidistrict litigation (MDL) claims that an Annals of Surgery study said that Bard retrievable filters actually caused thrombi to occur in trauma patients, as opposed to preventing them.

The study also allegedly reported that patients who had had the filters implanted had twice as high a death rate as those who had not received them, and patients with IVC filters were five times as likely to develop deep vein thrombi than those without.

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