IVC Filters Are Defective, Lawsuits Claim
Blood clots can do significant damage if they dislodge and travel through the body. They can even be fatal if they reach the heart, lungs, or brain. Clots are typically managed with blood thinners and anticoagulants. However, some patients cannot take these medications safely. Medical device manufacturers came up with a solution: IVC filters.
IVC filters are designed to catch blood clots as they travel through the blood. The clot becomes lodged in the trap and its threat is neutralized. Device manufacturers, including C.R. Bard and Cook Medical, poured millions into marketing these life-saving devices. However, the companies failed to disclose that the filters may be unreasonably dangerous. Why? Defects in the devices allow them to migrate, shift, tilt, and break inside the body.
Since the patients didn’t know the risks associated with the filter, they weren’t given the chance to make informed decisions about their medical care. As a result, thousands of IVC filter patients have suffered otherwise-avoidable injuries. Many have taken matters into their own hands and filed product liability lawsuits against the device companies.
Why Are IVC Filter Companies Being Sued?
IVC filters are small, spider-like devices that are inserted into the body. Specifically, they’re placed into the inferior vena cava (IVC), the vein responsible for bringing deoxygenated blood from the lower half of the body to the heart. Blood clots often form int he legs and lower extremities. If they were to travel through the body, they’d travel through the inferior vena cava. Placing a filter in the vein limits the possibility of the clots reaching vital organs and doing serious damage.
IVC filters look like a spider. The trap has several legs on either side. These metal legs catch the walls of the vein and hold the filter in place. Many IVC filter lawsuits involve complications involving this aspect of the device’s design. IVC filters have been known to fail when the legs fall off, shift, or move.
When legs break off, they can travel through the body and cause significant harm. Patients have suffered perforated organs, infection, and other injuries because of this defect.
When legs fail to hold the device in place, the filter can shift, tilt, or migrate. This can cause, among other things, perforation and tissue damage. When it’s out of place, the device cannot properly trap any clots that pass by. As a result, patients are not protected from dangerous clots.
Finally, failure involving the legs can also cause the device to become lodged in the vein. This can make it next to impossible to remove the device from the body. Most IVC filters are retrievable and only intended to be used for a short period of time. In fact, the FDA even recommends removal no later than 54 days after insertion. Leaving an IVC filter in the body for too long is associated with severe health issues.
What’s the Basis for IVC Filter Lawsuits?
Medical device companies are required to comply with the laws of the states in which they operate. Product liability laws are in place to protect consumer safety. If a company designs, manufactures or sells a product, it has a responsibility to make sure that it’s safe to use.
A company can find out if its product is safe by conducting research and testing. Tests should indicate whether there are any defects that must be addressed before the product is sold. Similarly, tests would reveal whether there are any hidden or hard-to-identify risks associated with using a product. Any known hazards have to be passed along to consumers so that they can make informed decisions about the products they use.
When a company sells a defective device or fails to warn consumers about risks, it can be responsible for injuries under state product liability laws. IVC filter lawsuits are product liability lawsuits.
IVC Filter Manufacturers Took Advantage of FDA Loopholes
How did defective IVC filters get on the market? Wouldn’t testing reveal defects and dangers long before the filters were used by patients? Yes, if testing was actually done. Thanks to a loophole in FDA approval requirements, many device manufacturers were able to get agency approval with little-to-no testing.
Many manufacturers took advantage of the FDA’s 510(k) pre-approval process. This allows companies to get FDA approval if they can show that their device is similar to one that’s already on the market. The new product is essentially grandfathered in because the company says it is just as safe, if not safer, than an existing product. The trouble, however, is that this allows device manufacturers to skip critical testing stages in their development. As a result, patients are the real test subjects.