A federal jury in Indianapolis has ruled that Cook Medical must pay $3 million to a Georgia woman who suffered medical complications when the company’s blood-clot filter deteriorated inside her.
The Bloomington-based company announced the jury’s decision Wednesday afternoon. The medical-device maker said it would appeal the decision.
The plaintiff, Tonya Brand, also had asked for additional millions in punitive damages, but the jury rejected that request, Cook said.
“While we respectfully disagree with the compensatory damages and verdict, we appreciate the time and hard work of the jury,” said Cynthia Kretz, vice president and general counsel for Cook Medical. “We never want to see a patient with a poor outcome and we’re sorry that this patient experienced a very rare complication.”
The lawsuit was one of three “bellwether cases” heard in federal courts in recent years over the company’s blood-clot filters. More than 4,000 patients have filed lawsuits, claiming the filters malfunctioned, sometimes piercing organs and blood vessels, and requiring surgeons to remove them.
Cook won the first two bellwether cases, with a jury verdict in its favor in the first case and a summary judgment ruling by a judge in the second case.
Bellwether cases are small groups of lawsuits that are tried first and serve as a litmus test for how the remaining cases might be tried and decided.
Cook’s blood-clot filters are tiny, cage-like devices inserted into blood vessels to prevent clots from reaching the lungs, which could lead to pulmonary embolism, or blockage of an artery in the lung. Nationally, 100,000 people die each year from pulmonary embolism, according to the Centers for Disease Control and Prevention.
In the latest bellwether trial, heard before Judge Richard Young in U.S. District Court in Indianapolis, the patient had a Cook Celect Cava filter inserted in 2011, before spinal-fusion surgery. Several months after the filter was inserted, the woman discovered a “painful region” on the inside of her right thigh, which grew to a 5-inch area.
One day, she pressed on the protrusion that had developed on her thigh, and a piece of metal wire about 1-1/2 inches long popped out, which was later determined to be one of the struts of the filter.
X-rays revealed that a second strut had broken off and migrated near her spine. She underwent an operation, “but after several unsuccessful attempts to remove the filter during this surgery, the procedure was halted,” the complaint said. The jury found that the filter was defective.
Cook said all medical devices “have some degree of risk,” but physicians use the IVC filters based on the benefits “outweighing the small percentage of risk for patients that need to prevent potentially life-threatening clots.”