What did medical device maker C.R. Bard do after it learned problems existed with its blood clot filter? The medical device in question was developed to replace a different filter implicated in the deaths of 27 people? Bard continued selling the filters — more than 160,000 of them in a five-year period.
Bard is a New Jersey-based corporation that manufacturers medical devices, including blood clot filters. The U. S. Food & Drug Administration gave the company clearance to market the Recovery blood clot filter back in 2002. Soon thereafter, reports began to surface of injuries and deaths associated with the medical device. Twenty-seven deaths and hundreds of problems ultimately were reported.
In response, Bard brought to market the G2 series filters as a replacement for the Recovery filter. But just four months after the FDA gave its approval for sales of the G2 filter, similar problems came to light. Twelve deaths and hundreds of problems with the medical device reportedly have been filed with the FDA concerning the G2 filter.
Doctor Insists Bard Filters Should Have Been Recalled Sooner
The Bard filters are inserted into the inferior vena cava (IVC), the largest vein in the body, to prevent blood clots from finding their way to the lungs and heart. But Bard’s IVC blood clot filters were never safe, according to Dr. William Kuo, an interventional radiologist. Kuo, who directs Stanford Health Care’s IVC Filter Clinic, has removed 1,000 defective blood clot filters from patients over the last 10 years. Kuo has removed more Bard filters than any other brand. The Bard blood clot filters fracture into pieces that are then free to migrate into the heart. Kuo insists that the filters should have been recalled.
Bard’s internal memoranda reveal that Bard itself was aware in 2005, the year the FDA cleared the G2 filter, that the medical device could have problems with migration and perforation. A Bard vice president questioned why doctors should not rely on a different Bard filter which essentially had no complaints. Another Bard document indicates that the G2 filters had more problems with migrations and fractures than any of the filters made by Bard’s competitors.
A new large-scale clinical trial called PRESERVE is now underway in the U.S. to evaluate the safety and effectiveness of blood clot filters.
Contact Waters Kraus & Paul to Learn More About Filing a Defective Medical Device Lawsuit
Waters Kraus & Paul is a national plaintiffs’ law firm devoted to helping families in personal injury and wrongful death cases involving defective and dangerous medical devices, including metal-on-metal hip implants, transvaginal mesh and IVC filters. If you have suffered injuries or the death of a loved one associated with defective medical devices, contact us by email or call us at 800.226.9880 to speak with one of our attorneys, like Sara Coopwood in the firm’s Texas office, and learn more about how we can assist you with a defective medical device lawsuit or claim.