By Joe Fantini May 17, 2019

Thousands of IVC filter recipients have filed lawsuits against device manufacturers, claiming the blood clot filters are unsafe. A federal jury agrees. Cook Medical was recently ordered to pay $3 million to a Georgia woman for injuries caused by its Celect IVC filter.  Cook had won its two previous IVC filter battles in court.

Product Liability Lawsuits Target Medical Device Manufacturers

Cook Medical and other IVC filter manufacturers are subject to state product liability laws. These laws impose a duty to design, manufacture, and market safe products. If a company knows that a product is unsafe, it has to either fix the problem or warn consumers about the risk. A company can be held strictly liable for injuries caused by defects in their products.

Thousands of IVC filter recipients are relying on state product liability laws to hold medical device manufacturers accountable for their dangerous products. The patients claim that Cook Medical and other companies didn’t provide adequate warnings about the risks of getting an IVC filter. This deprived those patients of the ability and right to make informed decisions about their medical care. Now, they’re faced with painful, debilitating, and potentially life-threatening injuries. Some patients will die because they received a defective IVC filter.

Lawsuit Claims Celect Filter is Defective

Tonya Brand received the Cook Celect IVC filter in March 2009. In 2011, she began to experience unusual pain in her right thigh. Shortly after the pain began, she noticed a bump in her leg. The bump ultimately opened up, revealing an inch-and-a-half long metal wire.

Doctors determined that the wire was actually one of the legs of her IVC filter. The device had fractured in the body after implantation and migrated, putting her health at serious risk. Efforts to remove the defective device were not successful.

Brand filed a lawsuit against Cook Medical, accusing the company of (a) designing and marketing a defective device and (b) failing to warn her about potential health risks. Her lawsuit was consolidated in multidistrict litigation (MDL) with hundreds of others in the Southern District of Indiana.

Studies Reveal Celect Filters Prone to Failure

IVC filters have been at the center of controversy for quite some time. In fact, the FDA has even issued two separate advisories to warn patients about the risks of getting an IVC implant. Studies have revealed that Cook IVC filters – including the Celect device – are prone to early failure.

A 2012 study focused on 272 patients who received a Celect IVC filter or Gunter Tulip device. The findings revealed that nearly all of the patients suffered perforation because of an IVC filter malfunction. The filter had tilted in 40 percent of those cases.

A 2015 study found that the Celect devices were more likely to fail than other IVC filters. Specifically, the Celect filter demonstrated a high rate of strut perforations, similar to what Tonya Brand experienced.

These studies show that the risk of IVC filter complications increases the longer the device remains in the body. Retrievable filters may not be retrievable, after all, if they remain in a patient for too long. The FDA formally recommends that IVC filters are removed within 29 to 54 days after implantation.