And while the lawsuits continue to grow, some critics question whether the IVC filters are effective at all. If they are effective, then for some patients the side effects might be worth the risks, but if they are not effective, they may be putting patients at an unnecessary risk of serious side effects.
Those side effects reportedly include a risk of the filters fracturing and/or migrating from the site of their implantation. Of concern are temporary filters that are implanted to help a patient overcome a short-term risk of blood clots - from a car accident or surgery, for example - but that are not removed in a timely manner. Failure to remove a temporary filter puts the patient at risk of IVC thrombosis, a rare but deadly condition. According to the US Food and Drug Administration (FDA), temporary filters should be removed between 29 and 54 days of implantation, if the risk/benefit profile deems removal of the device favorable.
IVC filters are implanted into the inferior vena cava of patients who cannot tolerate anticoagulant medications or other therapies designed to prevent blood clots. The filters have legs that trap blood clots and prevent them from causing pulmonary embolisms. But some filters allegedly have a risk of fracturing, migrating or perforating the patient’s veins or internal organs.
Patients say they were not properly warned about the risks associated with the medical devices. As of May 16, 2016, there were 527 lawsuits consolidated for pretrial proceedings in MDL 2641 (In Re: Bard IVC Filters Products Liability Litigation), up from 93 in March. There were also 383 lawsuits consolidated in MDL 2570 (In Re: Cook Medical, Inc, IVC Filters Marketing, Sales Practices and Products Liability Litigation), up from 289 in March.