(Feb. 9, 2019) — An IVC filter company, Cook Medical, was hit with a $3 million verdict on Feb. 1 by an Indianapolis jury. The jury returned their verdict just before midnight Friday. They ruled that the Cook filter placed inside the plaintiff was defective.
Cook Celect Filter Trial
The case involved a 51-year-old dental hygienist whose Cook Celect inferior vena blood clot filter fractured and migrated in her body, eventually poking through her thigh and requiring open laparotomy surgery to remove.
Surgeons placed the controversial filter – which is alleged to trap blood clots – into the woman’s inferior vena cava March 2009 during lumbar spine surgery. She complained in the next few months about hip pain, severe abdominal pain, and pain and swelling.
A CT scan in June 2011 showed her IVC filter had fractured in a prevertebral location abutting the anterior aspect of the L2-3 disc space and upper L3 vertebral body. A follow up visit found a “palpable mass” in the skin under her right leg. The next day the woman pulled a 2-inch long metal object from her right thigh. That object was part of the filter which had fractured inside of her vena cava and migrated.
In July 2010, surgeons attempted to remove the broken IVC filter but were unsuccessful. Then, finally in October 2015, surgeons were able to remove what was left of the filter device.
Texas State Court Loss was Cook’s first
The troublesome filter in the Indianapolis trial concerned Cook’s “Celect,” which was also the subject of a jury trial and a subsequent verdict against Cook last Spring in Texas.
In May 2018, a state court jury awarded a Houston-area firefighter $1.2 million for a defective Cook Celect blood clot filter. The case was similar in that the person implanted with the filter required open laparotomy surgery to have it removed. And like the woman in this latest case, the plaintiff had it removed because it had migrated to where he feared it working like a “ticking time bomb” in his chest.
In the only other Cook IVC case to go to trial, an Indianapolis jury denied a woman’s claim for damages in summer 2017. But in that case – a defense pick for trial – surgeons had been able to successfully remove the filter without resorting to open laparotomy surgery.
IVC Filter Problems
IVC filters have proven troublesome because even though they are often used as medical devices in the hopes that they will prevent DVTs, much evidence suggests that they don’t pass a risk-benefit analysis which is the gold standard of any medical device treatment. Much evidence suggests that they have become accepted despite lacking evidence of being worth their risks.
IVC Filters give no benefit for Trauma Patients
Even though they are often used in trauma patients without the patients’ consent, there is no evidence that they offer trauma patients any benefit and are worth their risks.
No Long-term Benefits
Evidence has also shown that the longer removable IVC filters remain inside a patient’s vena cava, the more likely they are to cause problems.
In addition, evidence suggests that IVC filters don’t protect the patient from developing deep vein thrombosis (DVT) as well as their makers claim they do, while at the same time they can cause other problems which one who opts not to have a filter installed would not otherwise experience.
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by Matthews & Associates