IVC Filter LawsuitIn August 2010, the FDA issued a warning to doctors, alerting them about the risk of problems with retrievable IVC filters, such as those manufactured by Cook and C.R. Bard. The agency indicated that the blood clot filters should be removed in many cases once the danger of a pulmonary embolism has passed. At least 900 adverse event reports have been received by the FDA involving complications from IVC filters. One of the most common complaints is of the filter, or a piece of the filter, breaking off and migrating through the patient’s body.
Has the government received reports of dangerous complications associated with IVC filters?
Yes. In 2010, the U.S. Food and Drug Administration (FDA) issued an advisory that it had received 921 adverse event reports involving IVC filters since 2005. Of these adverse event reports, 328 involved device migrations, 146 involved detachments of device components, 70 involved perforation of the IVC, and 56 involved filter fracture. Some of the fractured pieces ended up in the heart or pulmonary artery and had to be removed by risky surgery. The number of actual adverse events is likely much greater as physician and device manufacturers are not required under the law to report complications with medical devices to the FDA. In a 2014 safety communication, the FDA recommended that physicians responsible for the care of patients with retrievable ICV filters consider removing the filter “as soon as protection from pulmonary embolism is no longer needed.” The FDA further noted that the risk/benefits of ICV filters “begin to favor removal of the IVC filter between 29 and 54 days after implantation.”s after implantation.”
What are the risks associated with IVC filters?
Several studies have found that the prolonged presence of certain retrievable IVC filters is linked to serious, even fatal, complications including:
Again, retrievable IVC filters are intended to provide temporary protection from blood clots in the lungs. Yet, most of these filters are left permanently in the patient. This is because the removal of IVCs requires invasive surgery and can pose significant risks. A report published in 2015 found that the prolonged presence of IVC filters was “associated with retrieval failure rates as high as 43%.”
Why are manufacturers legally responsible for injuries patients with IVC filters have suffered?
Manufacturers of medical devices owe a duty to patients to produce safe and effective products. This requires that manufacturers test their products for any defects prior to introducing them to the market. Further, medical device makers must inform patients and their physicians of any adverse health effects from the use of the devices. Failure to meet this duty leaves medical device manufacturers open to product liability and injury lawsuits. Lawsuits filed against C.R. Bard and other retrievable IVC filter makers allege that these companies knew or should have known that the devices were defective for several reasons:
The defendants misrepresented the risks associated with retrievable ICVs and failed to issue appropriate safety warnings to patients and physicians.
- The defendants failed to conduct appropriate testing, including human clinical testing, to determine how the devices actually functioned in the body once implanted and after remaining in the body for an extended period,
- Published medical studies have found numerous complications from prolonged presence of IVC filters including fracture, device migration, perforation of the vena cava wall, organ penetration, and increased risk for venous thrombosis,
- To reduce the risks of life-threatening complications from retrievable ICV filters, it is necessary to remove them, which requires invasive surgery and often is unsuccessful,
- The defendants misrepresented the risks associated with retrievable ICVs and failed to issue appropriate safety warnings to patients and physicians.
What types of legal claims may patients bring against IVC filter makers for their injuries?
In general, patients may file IVC Filter Lawsuit for the severe pain and significant injuries they suffered as a result of a medical device that is defective or unreasonably dangerous or fails to perform as claimed by the manufacturer. In most states the legal claims that may be brought include negligence, strict liability for design defect, strict liability for manufacturing defect, strict liability for failure to warn, and breach of warranty.
What recovery will I receive?
In most jurisdictions, if you suffered a personal injury and the defendant is found liable, the defendant is responsible for paying for your medical care, both past and expected and also past and future lost earnings and loss of earnings capacity, and an amount to compensate you for pain and suffering, mental anguish, and physical impairment. Your spouse also might be entitled to an award if he or she has a loss of consortium claim. If the conduct that caused the injury was egregious, you may also be entitled to an award of punitive damages in certain states. In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.