By Joe Fantini June 18, 2019

A pulmonary embolism occurs when a blood clot travels through the veins and reaches the lungs. IVC filters were designed to prevent this from happening. The filter sits in the inferior vena cava and catches blood clots before they have a chance to cause any significant damage.

Unfortunately, a new study reveals that IVC filters may actually increase the risk of pulmonary embolism and death in elderly patients. A device that’s supposed to help save lives is contributing to avoidable deaths.

Higher Mortality Rate in Elderly Patients With IVC Filter

The study focused on two groups of elderly patients who were hospitalized in California, Florida, and New York for acute pulmonary embolism. The first group included more than 214,000 Medicare patients, 13.4 percent of whom had an IVC filter. The second group included more than 76,000 patients, 18.2 percent of whom had an IVC filter.

Researchers compared the mortality rates of patients who’d received an IVC filter with those who hadn’t. They discovered that the 30-day mortality rate for Medicare IVC filter patients was 11.6 percent. The 30-day mortality rate for non-IVC filter Medicare patients was 9.3 percent. The same trend was discovered in the non-Medicare group.

At the conclusion of the study, the researchers expressed their concern about “the widespread use of these IVC filters.” Their analysis showed that elderly patients with an IVC filter were actually more likely to die than those patients who received a different type of treatment.

IVC Filters are FDA Cleared

You might think that a medical device has to be subjected to rigorous testing and studies before it can be implanted or used in patients. However, you’d be wrong. Class II medical devices, including IVC filters, are largely untested. Defects and dangers are only discovered after they’ve been widely used in medical procedures across the country.

How is this possible? IVC filters aren’t FDA approved. They’re FDA cleared. There’s a big difference between approval and clearance. To get FDA 510(k) clearance, IVC filter companies simply have to say that their device is substantially similar to a device that’s already on the market. It doesn’t even matter if that other device works or is safe. It’s possible for a company to rely on an existing device that’s been pulled from the market to proven to be dangerous.

State Product Liability Laws Protect Consumers

IVC filter manufacturers, including C.R. Bard and Cook Medical, are largely responsible for making sure that the medical devices they sell are safe. There’s very little oversight from the FDA, especially through the clearance process. Product liability laws exist to encourage companies to make safe products. Consumers can sue under these laws if they’re injured because of a dangerous or defective product.

In California, there are three primary ways to go about filing a product liability lawsuit. Injured consumers can recover compensation if they were injured by a product that was dangerous because of a:

Many IVC filter patients have invoked their state’s product liability protections. Thousands of IVC filter lawsuits claim that:

Medical device manufacturers can be held strictly liable for harm caused by their defective products. Consumers don’t have to prove that a company was negligent in designing, making, or selling a device. The company is held accountable simply because its product was dangerous. Strict liability is intended to force companies to test their products thoroughly before selling them to the public.