If you or a loved one has received an IVC filter implant, you may already know about the risk of serious injuries linked to these devices. IVC filters help prevent blood clots from reaching the lungs and causing severe medical complications. However, recent studies suggest that improperly placed or removed implants may have dangerous side effects.
IVC Filters: What You Need to Know
An IVC filter is a tiny device that doctors insert into the inferior vena cava, a major blood vessel that carries blood from the legs to the heart. IVC filters catch blood clots that may break off from the legs and travel to the lungs, potentially causing severe medical complications, including death. However, these filters can break apart or move from their original position, resulting in serious harm to patients. Some of the injuries associated with IVC filters are:
– Blood clots
– Device migration
– Filter fracture
– Perforation of the vein or other organs
– Infection
– Pain
– Hemorrhage
Uncovering the Hidden Dangers of IVC Filters
In the 1980s, IVC filters were first invented as permanent placement devices. Over time, advancements in technology led to the creation of four different categories of filters: permanent, temporary, convertible, and optional. Among these types, C.R. Bard developed the Recovery filter in 2003, which received much attention. The ability to remove the filter after medical treatment has improved, benefiting both patients and doctors. However, the device has been associated with serious complications such as device migrations, embolizations, and inferior vena cava perforations. Since the introduction of the retrievable IVC filter, the FDA has received approximately 950 adverse reports. In 2010, the agency published a safety alert warning the public about the risks of long-term use of these devices and the importance of monitoring by medical professionals.
FDA Safety Alert and Manufacturer Warnings
In 2015, the FDA issued a warning letter to C.R. Bard, Inc., a known manufacturer of these defective devices. The letter stated that Bard had not obtained FDA clearance for the Recovery Cone Removal System. Additionally, the manufacturer did not meet current good manufacturing practices in their methods of storing, manufacturing, and packaging. They also failed to establish and maintain proper procedures for reviewing and evaluating complaints related to the G2, G2X, and Eclipse filters. Furthermore, they neglected to report information suggesting device malfunction and the potential for death or serious injury if used.
One regulatory specialist, Kay Fuller, warned Bard in 2002 that the recovery filter did not meet safety standards, but her concerns were ignored. The company fraudulently obtained FDA clearance, even forging Fuller’s signature on the 2002 application. Although the manufacturer was aware of issues with the IVC filters in 2005, no action was taken. Instead, they made slight modifications to the filter and rebranded it as the G2. Consequently, countless patients have suffered due to the company’s inaction.
Victims of Adverse Effects and Lawsuits Against Manufacturers
Manufacturers like Cook Medical and C.R. Bard have faced numerous lawsuits due to their negligent actions, leading to physical and emotional distress for victims of these devices. These victims deserve justice, and many lawsuits have already resulted in financial compensation for injuries or wrongful death. The lawsuits against the manufacturers of these devices allege that they were aware of the associated risks but failed to warn the public or implement proper monitoring programs sufficiently. Victims have filed IVC filter lawsuits seeking accountability.
Ongoing Lawsuits Against Cook Medical and C.R. Bard
Cook Medical is currently dealing with numerous ongoing lawsuits, with the number of active IVC lawsuits reaching nearly 8,000 as of June 2023. Most of this litigation is concentrated in an MDL. Cook Medical has experienced a mix of outcomes in court, achieving victory in its first bellwether trial in November 2017 but facing a setback in a Seventh Circuit ruling in December 2022 that favored two Cook IVC filter plaintiffs. These rulings highlight the complexity and inconsistency of IVC filter lawsuits. Those involved in such litigation should seek experienced legal guidance to navigate the process and assess the likelihood of a favorable outcome.
A significant development in recent years is the settlement of several major IVC filter cases. C.R. Bard, a leading manufacturer of these devices, agreed to pay $200 million in 2018 to settle over 3,000 lawsuits. This verdict was a major win for plaintiffs who claimed serious health complications from Bard’s IVC filters, including device migration, perforation, and fractures.
Besides Bard, other manufacturers also face a barrage of lawsuits. Cook Medical, another major producer of IVC filters, currently faces over 10,000 lawsuits nationwide, with the first trials scheduled for 2023.
Importance of Filing Lawsuits and Seeking Legal Counsel
If you experienced an IVC filter injury, it’s crucial to seek legal assistance to understand your rights and options. Hold pharmaceutical companies accountable for the dangerous complications caused by their devices by filing a lawsuit. The attorneys at Gallon, Takacs & Boissoneault Co., L.P.A. are dedicated to helping those affected by IVC filter injuries. We understand the challenges of dealing with medical complications and are here to assist you in navigating the lawsuit filing process. Contact us today at 419-843-6663 or fill out our contact form for a free case evaluation and rightful compensation.
