A woman has filed a IVC filter removal lawsuit against the makers of her medical device, the Gunther Tulip Inferior Vena Cava Filter.

The inferior vena cava, companion to the aorta, returns deoxygenated blood back to the heart for replenishment. It can also carry blood clots which are fatally implicated in myocardial infarction (heart attack), respiratory arrest and stroke.

Inferior vena cava (IVC) filters, designed to be implanted in this major vein, strain the blood for clots. While there are benefits, many adverse medical events have been reported. On June 23, 2017, another Gunther Tulip IVC filter removal lawsuit was filed in U.S. District Court in the Northern District of Illinois.

IVC Filter Removal Failure

In this IVC filter removal lawsuit, plaintiff Maureen F. alleges she had a Gunther Tulip IVC filter implanted in her inferior vena cava on June 24, 2011. According to the legal documentation, this surgical procedure took place at Edward Hospital in DuPage County, Illinois.

In February 2016, a little less than five years later, the plaintiff presented to a different hospital with unexplained and severe pain in the back and abdominal regions. Imaging tests confirmed that the Guenther Tulip IVC filter had migrated from its original implantation site and was in danger of damaging a nerve of the major vein by perforation.

Despite this woeful report, it still took three months to schedule the necessary surgical removal of the blood-filtering device. In April 2016, Maureen F. was admitted to Adventist LaGrange Memorial Hospital to remove the filter.

According to the statement of facts in the legal paperwork, severe problems arose with the IVC filter removal leading to a major blood clot in the vena cava that affected her right leg.

Defendant’s Marketing History

The developers, makers, and promoters of the Gunther Tulip IVC filter, Cook Inc. and all its affiliated companies, marketed the Gunther Tulip IVC filter as a safe and secure method of preventing migration of blood clots causing pulmonary embolism (PE) or deep vein thrombosis (DT) in those individuals prone to producing them.

This marketing tactic was taken despite the medical device having been fast-tracked through the Food and Drug Administration’s (FDA) approval system via the 510(k) program.

The 510(k) program allows companies to bypass lengthy clinical trials and safety testing prior to public distribution if they can prove the drug or device is very similar or identical to another product already on the market.

The Gunther Tulip IVC filter removal process was supposed to go smoothly. Cook Inc. had promoted the device as suitable for short or long-term use. Its ability to be removed easily was a key attribute of that advertising campaign.

According to the legal documentation, the defendants could have easily ascertained any risks associated with the IVC filter had they done an appropriate amount of safety testing prior to release of the medical device.

The plaintiff, Maureen F., brings two counts against the Cook Inc. defendants in this IVC filter removal lawsuit. The first count is negligence and the second count is strict product liability.

She is asking for a trial by jury and a favorable judgement on her behalf against the defendants which would include an amount awarded of at least $75,000 for her past, present, and future pain and suffering.

The IVC Filter Removal Lawsuit is Case No. 1:17-cv-04733, in the U.S. District Court for the Northern District of Illinois, Eastern Division.