Cook Nester and Tornado Coil Lawsuits News

Cook Medical Has A History of Faulty Medical Devices

Medical device manufacturers are cutting corners on patient safety ever since the FDA implemented its failed fast-track approval system

Thursday, August 27, 2020 - Regulators may be about to take a deeper look into the manufacturing and marketing practices of medical device manufacturers like Cook Medical for producing faulty and dangerous medical devices. Recently, Cook Medical has been accused of negligence in failing to warn patients of the complications that could occur as a result of the Cook Embolism Coils breaking and migrating within the body and damaging the lungs or other vital organs. Cook Medical has been the subject of hundreds of lawsuits in the past by plaintiffs claiming that the company's IVC filter experienced similar migration problems causing organ damage. An IVC filter is a spider-like device inserted into the inferior vena cave, the largest blood vessel, to trap blood clots before they reached the heart or lungs. Patients are suing Cook Medical for misleading them to believe that the device could be retrieved. Lawsuits allege Cook Medical was obligated to know that their IVC filters could perforate the vena cava wall and potentially cause damage to other organs. Cook Medical failed to warn physicians and patients about the dangers of the medical device's migration and the resultant inability of removal. Cook Coil lawsuits are handled by top national attorneys currently accepting claims for review and offer a free consultation before filing a lawsuit claim.

Another example of the Nester and Tornado embolism coil malfunctioning is in the FDA's MAUDE database. The registry has recorded the complaints of patients whose embolism coil migrated away from the spot where it was supposed to repair an embolism and damaged the patient's lungs or other organs. When the coil breaks, it can result in severe, chronic pain, bleeding, clotting problems, hematomas, hemorrhage, ischemia, and tissue necrosis. Sometimes the victim of a failed Cook embolism coil may require surgery to remove the defective device however doctors may decide that it would be too dangerous to operate to try and remove the device and instead opt to leave it poking into the vital organ until the patient's pain becomes unbearable.

Another complaint, this time published by the National Institute of Health (NIH) titled: Migrated embolization coil causes intestinal obstruction, claims that "Embolization coils can migrate to various destinations, causing delayed complications in several case reports. A case of small bowel obstruction due to migrated embolization coils from a gastroduodenal pseudoaneurysm 6 years after initial treatment is presented." Bowel perforation or obstruction can cause the contents of the bowels to leak into the abdominal cavity and cause death.

Cook Medical's history of manufacturing faulty medical devices may be traced to the FDA's inability to screen such defective products from coming to market in the first place. Most medical devices today are not subject to strict human testing before they are offered to the public. As a result, doctors are unaware that the devices have not proven that they work, only that they are similar to other medial devices already on the market. Cook Inc's Nester and Tornado embolism coil was awarded fast-track approval in May of 2016 without human testing, nor were doctors required to show the specialty skill needed to perform the complicated installation procedures.

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