Inferior vena cava filters, commonly called IVC filters, are used by vascular surgeons to prevent blood clots in the veins from entering the heart or lungs. Patients diagnosed with deep vein thrombosis or pulmonary embolus, trauma victims, and patients unable to take blood thinner medications are among the candidates for IVC filter implantation. This medical device, marketed as temporary and retrievable, is presumably placed in the vena cava vein until the threat of an embolism has passed. However, reports of life-threatening side effects and post-surgery complications have led to lawsuits of negligence against manufacturers C.R. Bard and Cook Medical.
IVC Filter Side Effects
In 2010, the Federal Drug Administration (FDA) released an official warning of potential risks involved with IVC device. Over 300 patients had reported that the filter moved from the intended implantation site, known as device migration. A total of 56 cases of filter fractures were documented by that point, as well as 70 cases of organ perforation. A total of 146 embolisms were reported. The FDA encouraged removal of the device at the earliest possible opportunity, upon recovery from clotting threat. In 2014, the agency updated this warning, stating a more concise removal time frame of between 29 and 54 days after implantation.
Unsuccessful IVC Filter Removal Attempts
The five most controversial types of IVC filters are:
- The Bard Recovery filter
- The Bard G2 filter
- The Bard G2 Express filter
- The Cook Celect filter
- The Cook Gunther Tulip filter
Marketed as temporary devices to be removed after recovery, these five medical products became the target of a 2013 study by the Journal of American Medical Association. In examining 680 IVC filter patients, research revealed only 58 filters were able to be safely removed.
Failure by surgeons to remove the filters was due to:
- Embedding of the filter to the body’s internal tissues
- Puncturing of the blood vessel by a part of the filter
- Migration of the device to an unsafe position
- Existence of a blood clot within the filter
Manufacturer Failure to Warn
Claims against C.R. Bard and Cook Medical include various forms of negligence, ranging from negligent misrepresentation and design defects, to breach of implied warranty. The most controversial of negligence claims regards the failure to warn. In 2004, Dr. John Lehmann was hired by C.R. Bard as an independent consultant after malfunctions were reported. After conducting a study of the device’s fracture and migration rate, Dr. Lehmann recommended further investigation on the high complication rate of the company’s Recovery filter. However, his findings were never reported to the FDA or the public. This incidence has become the basis for various individual and class action lawsuits against C.R. Bard.
Altman & Altman, LLP – Massachusetts’ Defective Medical Product Lawyers
Various individual and class action lawsuits have been filed against the companies producing the IVC filters. Many of the victims have suffered life-altering conditions due to the device’s defective nature. Experiencing this type of injury, or the loss of a loved one, due to preventable causes can be extraordinarily overwhelming. Victims may face years of medical expenses and lost wages. At Altman & Altman, LLP, our experienced legal team believes in fighting for fair compensation when the legal duty to offer safe products is breached. Our products liability attorneys have nearly 50 years of experience recovering financial losses due to defective medical equipment. If you have experienced a physical setback due to the IVC filter or any other defective medical device, contact us today for a free consultation.