NBC Report: IVC Filter Cover-Up and Forgery
Alabama IVC filter attorneys like the ones at Farris, Riley & Pitt can assist you if you have questions about your IVC filter and the injuries being reported about this commonly used medical device. A recent news story highlighted some of the health concerns facing many recipients of IVC filters.
C.S. Bard is one of the leading manufacturers of inferior vena cava filters, more commonly known as IVC filters or IVFs. In September 2015, NBC news aired an investigative report about this medical device giant that called into question the ethics and safety practices of the company. The news story alleged that Bard had knowledge that their Recovery filter was dangerous to patients and that they tried to prevent this information from becoming public. NBC’s investigation also suggested that the manufacturer may have forged a document that was a crucial part of obtaining FDA approval for the Bard Recovery IVC filter.
What is an IVC Filter?
An IVC filter is a medical device that gets implanted in the largest vein in the body, the inferior vena cava. Its purpose is to catch potentially deadly embolisms before they reach the heart and lungs. The device is typically used to help patients who suffer from deep vein thrombosis (DVT) or are otherwise at significant risk of developing blood clots after surgery. An IVC filter is not used if a patient can be treated with traditional anti-coagulant medication such as Warfarin or Coumadin. The Bard Recovery filter is designed to be retrieved once the danger of blood clots has passed.
According to the NBC news story, each year approximately 250 thousand people are treated with IVC filters made by 11 different manufacturers in the United States. For many patients, the devices cause no adverse effects at all. The NBC report revealed, however, that the Bard Recovery filter harmed hundreds of patients and contributed to the death of at least 27.
How does a medical device designed to help stop blood clots cause so much damage? An IVC filter is built like a cage or spider and has “legs”. Many of the injuries and fatalities have resulted from the “legs” breaking off, migrating through the veins, and piercing or lodging in the heart or other body parts. In one case, blood clots became trapped in the Bard Recovery filter and the entire device broke free from the vena cava. The entire filter lodged inside the heart killing the patient. In another case, a one inch leg of the filter broke off and became embedded inside the patient’s heart requiring emergency open heart surgery.
Early Trouble Detected with the Recovery Filter
For their report, NBC news interviewed Kay Fuller, a regulatory specialist hired by Bard in 2002. When Bard’s first attempt to secure the approval needed to sell the Recovery filter failed, the company hired Ms. Fuller to help obtain the necessary FDA clearance.
According to Ms. Fuller, she became immediately worried about the safety of the Recovery device. She told NBC that Bard did not release certain safety test results to her which she needed to properly review the device. Ms. Fuller also said that she was quite concerned about the findings of a small human clinical trial study conducted with the Recovery filter.
Fuller further stated, that when she brought her concerns to the attention of the appropriate people at Bard “It was basically, you know, if you continue to pursue these questions that I was going to be asked not to be on the team.” Fuller also told Bard that she would not sign any FDA application until the issues were resolved and her concerns addressed.
Bard submitted the application to the FDA, and it was approved, with what appears to be Fuller’s signature. When NBC news asked her why she eventually signed the application, she responded: “I will tell you I did not sign it.” Fuller stated that her name was put on the application without her knowledge.
Fuller added that before the Recovery filter was approved she privately reported her concerns to the FDA and resigned from Bard. Bard has disputed Fuller’s claims and the FDA has declined to comment other than to say that it takes these matters seriously.
After Approval, Even More Trouble for the Bard Recovery IVC Filter
NBC obtained documents revealing that more than a decade ago, Bard already knew that the Recovery filter was harming patients. The documents show that Bard hired a public relations firm to address the situation. Their “crisis management report” expressed concern that bad press and publicity about the IVC filter would negatively affect Bard’s stock prices.
Bard also hired an independent doctor to conduct another study on the safety of the Recovery. NBC obtained the “confidential report” issued by the doctor and revealed the results: The Recovery IVC filter had higher risk of death, fracture and movement than other IVC filters on the market. The report urged Bard to further investigate the dangers of the Recovery filter. Despite the results of the study and increasing reports of injuries, Bard did not recall the filter. Instead, Bard continued to sell the Recovery IVC filter for three years before finally releasing an updated version.
Lawsuits are Being Filed Against C.S. Bard
Over the years, there have been hundreds of reports of patients being injured by IVC filters made by Bard and another medical device manufacturer, Cook Medical, Inc. Some victims have filed lawsuits seeking damages for their injuries. The cases allege that the manufacturers made defective devices and failed to warn patients of the dangers of IVC filters. These lawsuits have been consolidated into two multi-district litigation groups. The NBC report of Bard’s possible “cover-up” may spur even more litigation.
Contact Alabama IVC Filter Attorneys at Farris, Riley & Pitt
If you have an Alabama IVC filter, speak with your doctor about the risks. If you have an injury because of your filter, you should speak with our attorneys about bring and IVC filter lawsuits to protect your legal rights. You may be entitled to recovery monetary damages. You may be entitled to receive compensation from the manufacturer the device is defective or that the manufacturer failed to warn patients and doctors of the risks.
The defective medical device lawyers at Farris, Riley & Pitt have the experience you need to handle your IVC filter claim. For a free evaluation of your Alabama IVC filter case call us at (888) 580-5176 today.