Doctors and surgeons often implant IVC filters in the lower vena cava of patients who cannot for a variety of reasons take anticoagulants and blood thinners. They are inserted in the body to prevent blood clots from getting into the lungs.
The IVC filter catches clots in the blood stream and over a few weeks or months, the clots will be broken down by the body. However, FDA has received thousands of reports of problems with IVC filters. Some of the most common problems with these advanced medical devices include punctured organs, perforated blood vessels and filter migration, sometimes into the heart or lungs.
In 2010, FDA sent out a warning to medical professionals that IVC filters can fracture, migrate, and perforate organs, and they need to be removed as soon as the chance of blood clots in the patient has lessened. FDA also updated this safety communication in 2014, and noted that most of the medical devices should be taken out by the 54th day after they were implanted. However, the warnings were too late, and patients started to file IVC lawsuits across the US as they claimed that the filters had caused injuries and death.
Medical Device Manufacturer Negligence
Major manufacturers of IVC filters with problems and lawsuits include CR Bard and Cook Medical. Five IVC filters have been the source of much of the litigation to date:
- The Bard Recovery filter
- The Bard G2 filter
- The Bard G2 Express filter
- The Cook Gunther Tulip filter
- The Cook Celect filter
Some of the lawsuits include claims of negligence, failure to advise patients of danger, defects in design and in manufacturing and breach of warranty.
Status of Litigation
Plaintiffs who had been harmed by IVC filters filed their first lawsuits against Bard in CA and PA in 2012. In 2014, a US judicial panel consolidated a number of lawsuits against Cook from more than 10 districts. The total number of IVC filter lawsuits against Cook increased to over 100.
In Feb. 2015, CR Bard settled an IVC filter lawsuit case 10 days after the trial started. The lawsuit stated that the Bard IVC filter broke up inside the man’s body and one of the tiny metal legs entered his heart. He had a perforation of the heart and it forced him to have heart surgery and this took months of recovery.
Another judicial panel consolidated lawsuits against Bard in Arizona in 2015, and there are now 50 lawsuits pending there.
Another IVC filter patient sued Bard after their GT2 filter that was implanted in 2005 broke up and migrated to the heart in 2008, which caused her serious heart problems. The woman did not want to have open heart surgery to take the pieces of the filter out, and she will have to take blood thinners for life. She claimed in her blood clot filter litigation that her doctor did not warn her of the device’s risks and told her that the device was safe when it was not. She has filed a lawsuit for physical and mental trauma, anxiety and loss of income.
Another patient and her husband also filed litigation against Bard after their G2 filter broke up in the woman’s body in 2010. The device traveled to various parts of her body and caused damage to her heart and lungs. Her lawsuit claims that she has suffered the loss of a normal life, suffering, pain, disfigurement, disability and emotional trauma. The husband claims that he has suffered loss of companionship with his wife. The lawsuit claims that Bard was negligent in the design of the device.
Another patient also has sued Cook for the alleged reckless design, test and building of the Celect filter. A doctor put the device in the patient in 2010 after he had knee surgery. The device fractured and then migrated to the heart in 2013. He lose consciousness while driving and has had to have three more surgeries to correct the problem. The lawsuit is seeking damages to compensate the patient for his emotional suffering, pain and inability to enjoy life.
Life Threatening Side Effects of Retrievable Blood Clot Filters
Blood clot filters are designed to prevent pulmonary embolisms or PE, but they also can have many serious side effects that can injure and kill people. According to an FDA report released in 2010, FDA has gotten nearly 1000 reports of adverse events due to the implantation of IVC filters.
Some of the most common adverse events include filter perforations, 328 device migrations, 56 filter fracture and 145 embolisms.
Bard Knew About IVC Filter Risks
Only a year after the Recovery filter was launched, Bard got complaints from users about medical device malfunctions that indicated that the legs of the blood clot filter could break loose and migrate to other areas of the body. The firm then hired a consultant to do a report to compare fracture and migration rates of the newer filters to models from 2004.
Even though Bard knew about the risks with the filters and the problems they were having, they did not tell FDA or the public. The consultant completed his study and found that their Recovery filter had a higher number of problems and complications than competitors. However, the lawyers for the company only told a certain number of employees and told them to keep it a secret.
When litigation for the filters hit the courts, the report from the above consultant went public. Bard still argued that the report should be confidential because of the work product doctrine. This is law that provides protection of internal documents for a company if they are made in anticipation of future lawsuits.
It also has been discovered that Bard may have forged a signature on an FDA application for the Recovery device. The company hired a regulatory expert to help them to receive FDA clearance, but the consultant was concerned about the safety of the blood clot filter and she would not support Bard’s application to FDA. Still, the signature of the person appeared on the application to FDA which led to its 510k clearance. The consultant said that she did not sign the form.
Bard continues to be sued for problems with its IVC filters as of 2016.