Patients who cannot tolerate blood thinners are faced with a deadly decision after surgery: should they risk blood clots, or be implanted with devices that could break inside their bodies? According to a recent investigation, the risks of these blood-clot filter devices were not only unnecessarily high, they were also known—and perhaps even deliberately hidden—by the manufacturer.
Investigations Suggest Bard Knew About Risks of IVC Filters
The Recovery filter devices, made by C.R. Bard, have been associated with at least 27 deaths since their initial FDA approval. In theory, the devices work to trap blood clots after they are implanted in the inferior vena cava (IVC) and prevent the clots from migrating to the heart or lungs, and are supposed to be removed a few weeks after surgery.
However, according to a recent NBC News investigative report, the manufacturer was well aware of the risks of the product, but continued to promote its use—and may have taken unethical and illegal actions to do so. Documents, statements, and lawsuits contain a number of allegations against C.R. Bard’s Recovery devices, including:
- FDA warnings. The Food & Drug Administration (FDA) soon began receiving reports about the dangers of the retrievable filters. In 2010, reported complications included device migration (filters breaking loose from their placement) and becoming stuck in other locations, puncturing organs and blood vessels, and breakup of the devices causing metal shards to travel throughout the body. The FDA warned that the devices should be removed as soon as possible, and no longer than the 54th day after implantation.
- Internal investigations. C.R. Bard responded to negative reports of the device by hiring an outside doctor to conduct an internal study of the device’s safety. The internal report on IVC Recovery filters, which has since been released to the public, found that the device had higher death rates of device failure, movement, fracture, and potential death than every one of its competitors.
- Failure to recall. Rather than recall the Recovery device, Bard continued to sell the IVC filters for another three years, implanting over 34,000 of the flawed filters before ultimately replacing them with a newer version, G2. To cope with the negative press, Bard sought the advice of public-relations firm Hill and Knowlton, who were tasked with mitigating the damage to Bard’s reputation, profits, and stock prices.
- Employee coercion. After the application for FDA approval was originally rejected, Bard hired regulatory specialist Kay Fuller for their next attempt in 2002. Fuller reported that the company refused to provide her with vital test results, and she raised concerns over the results of the device’s performance in a small clinical trial. When she went to company heads to ask questions, she was told that she would be removed from the team unless she ceased her efforts to get more information.
- Alleged forgery. Despite being told she would be asked to leave, Fuller says that she refused to sign the company’s FDA application until the issues with the device were resolved. However, Bard’s application shows Fuller's signature on it, which Fuller herself expressly denies writing.
What Should I Do If I Was Injured by an IVC Filter?
Several patients have taken action against defective IVC blood clot filters by filing lawsuits against Bard. The allegations vary from patient to patient, but have included design defects, failure to warn, manufacturing defects, negligence, misrepresentation, and breach of implied warranty. While some victims have already received a recovery for their medical costs and loss of income, many lawsuits are still pending in state courts.
If you have been severely injured by a migrating IVC Recovery device, we can help. Call Wayne Wright LLP at 800-237-3334 today to speak with an attorney about your options.