A Houston firefighter who claimed a Cook Celect IVC filter caused him serious pain and injuries has been awarded $1.2 million by a Texas state jury.
Jeffrey Pavlock suffered perforations to his blood vessels and organs as a result of the Cook Celect filter. A surgeon implanted the filter to prevent blood clots from reaching his heart and lungs.
The IVC filter was meant to be temporary and would be removed when the risk of blood clot has passed. But when doctors tried seven weeks later, they were unable to retrieve it. It has moved and embedded itself in a blood vessel.
The filter’s legs had also perforated Pavlock’s aorta and small intestine.
Doctors tried a second time but still could not remove the filter. Pavlock’s lawsuit claimed the device could move or break again, and that he would need a lifetime of health monitoring.
Inferior vena cava filters are intended to stop blood clots from reaching the lungs. But investigations show that manufacturers may have hidden IVC filter complications and the device’s potentially fatal flaws.
Cook Medical didn't warn doctors and patients alike about IVC filter risks, the jury said. Cook Medical has said it will appeal the jury’s decision.
The facts:
- IVC filters come with immediate and long-term complications, such as fracture and migration.
- Nearly 20 percent of IVC filter removal attempts were unsuccessful, like Pavlock’s.
- Permanent filters pose an even higher risk of deep vein thrombosis.
- Media organizations and the FDA are targeting manufacturers who hid the device’s complications from the public.
- Individuals implanted with IVC filters can seek help from trained advocates.
IVC filters are metallic, cone-shaped devices that protect against stroke and pulmonary embolism, which occurs when blood clots migrate to the lungs.
They act as an alternative to pharmaceutical blood thinners, recommended for patients unable to tolerate anticoagulant medications like Xarelto and Eliquis.
Medical manufacturers began developing the filters in the 1970s, and since then have introduced a host of complications. Many health professionals believe the device lacks an established safety profile.
IVC Filters were approved through the Food and Drug Administration’s fast-tracked 510(k) clearance program and skipped safety testing. Since then, the FDA has received more than 900 reports of filter fracture, device migration, organ perforation and deep vein thrombosis. And thousands of people will continue to have these potentially fatal filters implanted into their bodies.
NBC News led an investigation into IVC filters to assess the scope of the damage. Among 300 reports of IVC filter injuries, NBC also discovered that 27 people died from their complications in the last decade alone.
There are more than 8,000 IVC filter lawsuits in federal court. All claim the filters caused serious complications or death.
The Texas jury’s verdict is a step in the right direction, and hopefully, the trend will continue as these cases filter through the legal system. That way, with the right legal ramifications, no one else will be put in Pavlock’s grave situation.