Investigation Reveals 27 Deaths Associated With Filter Over the Last Decade
IVC filters are used in patients who are at a risk of suffering a pulmonary embolism, a blood clot in the lungs. The IVC filter is typically implanted near a patient’s groin in the inferior vena cava, the body’s largest vein, in order to trap any clots that may travel up from the legs, before they reach the lungs. However, many patients have reported adverse effects after implantation. In many cases, parts of the metal device have broken off and lodged in the lungs, heart, kidneys and other vital organs. In addition, there have been reports of the device shifting within the vein, making it nearly impossible to remove.
According to the NBC News report, approximately 250,000 filters are implanted in patients who are unable to take blood thinners. The Recovery filter manufactured by pharmaceutical company C.R. Bard, has posed an especially high degree of risk for patients. About 34,000 Recovery devices were sold before Bard replaced them with an updated model named the G2.
NBC also reported that Bard hired a veteran regulatory specialist to help the company’s efforts to obtain U.S. Food and Drug Administration (FDA) approval for the Recovery in 2002, after the FDA had rejected the company’s original attempt.
According to the report, the specialist stated that Bard did not provide her with the results of crucial safety performance test and that she was already concerned with the results of a different clinical trial involving the filter. However, when she let her concerns be known, the specialist told NBC that she was given the impression she would be removed from the Bard team if she continued to pursue the matter.
“This is extremely disturbing news that shines a very negative light on C.R. Bard,” said Russell Budd, president and managing shareholder of the national law firm of Baron & Budd. “IVC manufacturers must be above-board at all times when marketing devices that can have a major impact on a patient’s life, and be forced to deal with the consequences if their devices cause harm.”
About Baron & Budd, P.C.
The law firm of Baron & Budd, P.C., with offices in Dallas, Baton Rouge, New Orleans, Austin and Los Angeles, is a nationally recognized law firm with a nearly 40-year history of "Protecting What’s Right" for people, communities and businesses harmed by negligence. Baron & Budd’s size and resources enable the firm to take on large and complex cases. The firm represents individuals and government and business entities in areas as diverse as dangerous pharmaceuticals and medical devices, environmental contamination, the Gulf oil spill, financial fraud, overtime violations, deceptive advertising, automotive defects, trucking accidents, nursing home abuse, and asbestos-related illnesses such as mesothelioma.