Inferior vena cava (IVC) filters are lifesaving medical devices that can stop blood clots from traveling into patients' lungs, but they can also cause life-threating complications. Thousands of patients injured by IVC devices have filed IVC filter lawsuits nationwide. But what about patients with IVC filters who have not (yet) been injured? Can non-injured patients with IVC filters sue the manufacturers to cover the cost of medical monitoring, which might (through early intervention) lessen the severity of filter-related injuries?
The primary treatment for blood clots in the legs (deep vein thrombosis) is blood thinners. For patients who can't take blood thinners, the next best treatment is often an IVC filter. IVC filters are small metal cages that sit in a patient's vein. They allow blood to flow through the vein, while trapping blood clots (gel-like clumps of blood), much like a kitchen sink filter catches food debris. Doctors implant IVC filters to stop blood clots from traveling to patients' lungs, where they can cause life-threatening blockages (pulmonary embolisms).
IVC filters can be placed for permanent or temporary use. Doctors can retrieve temporary IVC filters when a patient's risk of pulmonary embolism passes.
Like all medical devices, IVC filters come with risks. Complications can occur when doctors place and retrieve filters (procedural complications), or problems with the filter itself can crop up later (delayed complications).
Procedural complications can be routine or they can stem from a health care provider's unreasonable mistake (medical malpractice). Delayed complications might be caused by a defect in the design or manufacturing of the IVC filter (product liability). This article focuses on delayed complications, which often have no symptoms and might take years to develop.
Delayed complications can include:
Fractures. IVC filters can fracture, breaking into multiple pieces that can travel through the vein toward the heart and lungs, causing pain and potentially life-threatening injuries.
Perforation. Sometimes a metal piece of an IVC filter will penetrate the wall of the vein and cause pain, bleeding, and bruising.
Migration. Intact IVC filters can migrate (move) from their original location toward the heart or lungs, causing injury or even death.
In 2010 and 2014, the Food and Drug Administration (FDA) issued safety communications to doctors and patients about problems associated with IVC Filters. The FDA described hundreds of reports of delayed complications and recommended that physicians remove IVC filters as soon as a patient's risk for pulmonary embolisms subsides.
The FDA has never ordered a mandatory recall of IVC filters, but some IVC filter manufacturers have voluntarily recalled certain models.
In recent years, plaintiffs have filed a large number of mass tort lawsuits against IVC manufacturers. Most plaintiffs claim that IVC filter manufacturers (primarily Cook Medical and Bard) designed, produced, and promoted defective medical devices that caused serious organ damage.
Injured plaintiffs typically seek damages (compensation for losses) for the harm caused by IVC filters, including:
Personal injury lawsuits typically require plaintiffs to prove that defendants caused them actual injuries, which is why having a medical diagnosis is a key step in most mass tort cases. Nevertheless, some non-injured plaintiffs implanted with allegedly defective IVC filters are suing manufacturers for the anticipated long-term costs of monitoring the devices.
A minority of states allow non-injured plaintiffs exposed to hazards, like asbestos, to pursue claims for "medical monitoring." Typically, plaintiffs join together to file class action lawsuits seeking medical monitoring costs from manufacturers. To prevail in a medical monitoring claim, non-injured plaintiffs with IVC filters would usually have to prove:
They've been exposed to a hazardous filter. Exposure in most medical device cases just means proving that the device was actually placed in the patient's body. Proof that the filter is hazardous is more complex and requires evidence of failure rates, FDA warnings, and expert testimony.
They have an increased risk of serious illness or injury caused by defendant's negligence or wrongful ("tortious") conduct. Here, plaintiffs have to prove that they face an increased risk of injury because of a hazardous IVC filter, and that they require monitoring because of defendants' design or manufacture of defective filters, failure to warn of their risks, or both.
A medical test for early detection exists and is reasonably necessary. Plaintiffs must prove that a monitoring program exists (such as medical imaging of an IVC filter) and is reasonably necessary for early detection of filter-related medical problems.
Medical monitoring is beyond a plaintiff's ordinary course of treatment. Patients generally pay for the costs of normal follow-up care associated with IVC filters. Patients who sue over IVC filters must prove that, because of their exposure to a hazardous filter, they require a monitoring program that is different from the follow-up care that doctors would ordinarily prescribe. Plaintiffs can recover only for the cost of increased care.
As of 2021, no court has certified a class of non-injured plaintiffs with IVC filters to pursue medical monitoring claims against manufacturers. But medical monitoring is a still-developing tort, and the frequency of individual and class action claims will likely increase.
To preserve their ability to file a lawsuit, non-injured plaintiffs with IVC filters must be aware of lawsuit filing deadlines (set by laws called statutes of limitations). In cases involving IVC filters, the statute of limitations typically doesn't start running on the date the device was implanted, or even the date the device fails. Under the "discovery rule," the window for filing a lawsuit typically opens when the patient discovers (or should have reasonably discovered) a problem with the IVC filter.
Product liability and medical malpractice lawsuits typically have their own dedicated statutes of limitations, but these deadlines vary from state to state. Talk to an attorney to understand how the applicable deadline might apply to your potential lawsuit.
Patients who sue or intend to sue IVC filter manufacturers must take reasonable steps to minimize their harm. Failing to mitigate damages can have a big impact on how much a plaintiff can ultimately collect, even when the manufacturer is clearly liable. So, what steps might patients with IVC filters take in order to make sure they're mitigating any damages that might be part of a future lawsuit?
If you've suffered an injury as a result of an IVC filter, get tips on finding the right lawyer for you and your case. If you have an IVC filter and aren't currently experiencing complications, you might want to talk to a lawyer about the possibility of a medical monitoring claim, and any other steps you can take to protect yourself and your prospects in any future lawsuit.