Following a three-week trial, a Houston-based firefighter was awarded $1.2 million after a jury found Cook Medical responsible for injuries that he suffered due to a malfunctioning vena cava (IVC) filter.
The filter in question is a small, wire device that is inserted into the inferior vena cava to catch blood clots before they can travel to the lungs. They are designed to prevent pulmonary embolisms in patients who are unable to use standard blood-thinning medications.
Jeff Pavlock, 35, received the Celect IVC filter in 2015. Subsequently, the filter tilted and migrated, and ultimately perforated his aorta and duodenum. His doctors made two attempts to remove the device. However, they were unsuccessful, as the filter was pressing against Pavlock’s spine and renal artery. He was then forced to undergo an open laparotomy to remove the filter from his body.
At the trial, Pavlock’s attorneys argued that Cook placed the Celect IVC on the market, even though the company was aware of its issues with perforations. The attorneys also pointed to independent research that linked the filter to a perforation rate greater than 79%. Additionally, the jury was shown a Cook Medical- sponsored study that the company presented to the FDA prior to the filter’s 510(k) clearance in 2008, which showed a zero percent perforation rate. The jury found that Cook failed to warn doctors and patients of the risks associated with the IVC filters.
In 2010, the U.S. Food and Drug Administration (“FDA”). reported that it had received over 900 adverse event reports involving retrievable IVC filters, including:
- 328 reports of filter migration;
- 145 reports of embolization;
- 70 reports of perforations; and
- 50 reports of filter fractures.
Four years later, the FDA issued a second alert, reminding healthcare providers to retrieve the temporary filters within 29 to 54 days after implantation in order to reduce the risk of patient harm. Further, an NBC news investigation linked IVC filters to 39 deaths. Thousands of others, including those listed above, have reported serious complications to the FDA.
This verdict makes the first such loss for the Indiana-based company, although it is currently facing over 8,000 similar IVC lawsuits throughout the country. Most of the 8,000 lawsuits are part of two federal multidistrict litigations, which combine similar lawsuits to move them more efficiently through the court systems. Pavlock’s lawsuit was not combined with any other case. Rather, he filed his lawsuit in Texas state court.
According to the Herald Times, Cook stated that it will appeal “on multiple grounds.” In a press release, Cook Medical stated: “We are disappointed in this outcome and do not believe this verdict is supported by the facts or the law. This one case does not change our position on continually defending this important, life-saving technology.”