A man from Tennessee has filed a lawsuit against Cook medical seeking compensation for his injuries. As per the plaintiff after implanting a vena cava filter he was injured. He accuses Cook Medical of negligence for selling a defective medical device, failing to warn about side effects, and breaching implied and express warranty. The lawsuit was filed on June 20, 2016 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) by plaintiff.There are more than 500 cases have been filed against cook IVC filter. All of the lawsuits cover filters that fractured, tilted, perforated internal organs, or became embedded in the heart. The filters are often impossible to remove when these complications occur.
According to the lawsuit, Plaintiff was implanted with a Cook Gunther Tulip IVC filter at Wellmont Health System in Kingsport, Tennessee. The Gunther Tulip was approved by the U.S. Food & Drug Administration (FDA) in 2000 for permanent placement and then in 2003 for temporary placement; the device was marketed as a revolutionary solution for patients in need of close management and control over thromboembolic disease. However, IVC filters have been linked to reports of adverse health complications including device migration, organ perforation, hemorrhages, blood clots, respiratory compromise and death.
An IVC (Inferior Vena Cava) Filter is a spider-like device which is used to filter blood clots and prevent them from reaching a patient’s lungs. A pulmonary embolism can cause permanent damage to the lungs and in severe cases, may even result in death. Serious Complications Include:
- Fracture of the IVC Filter
- IVC Filter Migratio
- Perforation, Puncture or Serious Damage to the Heart, Lungs or Vena Cava
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb DVT
- Hematoma or Nerve Injury at the Puncture Site
- Constant and Severe Pain in the Heart, Chest or Elsewhere in the Body
- Pulmonary Embolism
- Respiratory Distress
- Shortness of Breath
- Other Serious Injury and Death
The FDA has warned about this device for years as the result of receiving hundreds of adverse events reported in regards to the IVC filter. On May 6, 2014 the FDA addressed physicians and clinicians with an update to their information on IVC filters by saying that if the patient’s risk for pulmonary embolism (a condition in which one or more arteries in the lungs become blocked by a blood clot) has passed, their recommendation is to remove the IVC filter between 29 and 54 days after it was originally implanted. Interventional radiology, interventional cardiology, vascular surgery, trauma care, bariatric surgery, orthopedic surgery and primary care physicians were the target of this alert. Thousands of adverse events have been reported to the FDA, including life threatening hospitalizations and deaths.