An inferior vena cava (IVC) filter is a cage-like device that doctors implant to catch blood clots that have broken away from an arterial wall and migrated. The purpose of the device is to stop the blood clot from migrating into the lungs in patients at risk of developing blood clots who are not candidates for blood thinner medications. Günther IVC is a type of retrievable short-term IVC filter manufactured by Cook Medical. If a Günther IVC is not retrieved at the appropriate time, our IVC filter lawyers know that there may be a greater risk of filter fracture or migration, embolization, organ damage, and long-term complications. Additional surgeries may be necessary, and there is even a risk of death. If you were injured by a Günther IVC or another defective medical device, contact the experienced product liability attorneys at Moll Law Group. Billions of dollars have been recovered in cases in which we were involved.
In 2010, the FDA warned of an increased risk of complications when retrievable filters are not removed in a timely fashion. Since then, lawsuits have been filed against manufacturers of various IVC filters.
One study published in Cardiovascular Interventional Radiology in 2012 found that 100% of Günther Tulip IVC filters pierced the subjects' vena cava walls within 71 days of implantation, while 40% of them moved out of position. A study published in JAMA Internal Medicine in 2013 showed that fewer than 10% of filters used in the study were successfully removed from patients.
Medical device manufacturers are required to provide products that are safe, and if there are risks associated with the use of the devices, they are required to provide adequate warnings about them. The two strongest theories of recovery in Günther Tulip IVC filter cases are defective design and marketing defects (also known as failures to warn). Both of these are problems for which a manufacturer may be held strictly liable with the assistance of an IVC filter lawyer.
Plaintiffs may rely on two alternative tests to prove design defects. The first is the "consumer expectations" test, which looks at whether a product's design meets consumers' safety expectations. The second is the more commonly used "risk-utility" test, which examines whether the safety benefits of designing away a foreseeable danger are greater than the resulting costs of the alternative design. For this test, it is usually necessary for a plaintiff to retain a credible expert to put forward a feasible alternative design. Manufacturers may defend on the grounds that another factor was the true cause of a plaintiff's injuries, or that the way that the particular injury happened was not reasonably foreseeable and could not be designed away.
A plaintiff claiming a failure to warn under a theory of strict liability will have to establish that the defendant was the manufacturer or otherwise in the chain of distribution for the Günther IVC, the Günther IVC had potential risks that could be known in light of the knowledge accepted by the scientific community at the time of manufacturing or distribution, potential risks presented a substantial danger when the product was used in an intended or reasonably foreseeable way, ordinary consumers would not have recognized the potential risks, the defendant failed to provide adequate warnings, the plaintiff was harmed, and the failure to warn caused the injuries. After numerous adverse events involving a single product, it may be difficult for a manufacturer to disclaim the knowledge that its use involved a high risk of harm. All manufacturers are required to keep up to date on the latest information about their devices.
If you suffered injuries due to the use of a Günther IVC, our product liability lawyers are available to seek compensation for your injuries. Moll Law Group represents consumers in states throughout the nation, such as California, Virginia, New York, Pennsylvania, Ohio, Texas, and Michigan. Call us at 312-462-1700 or use our online form to set up a free consultation with an IVC filter attorney.