In the wake of several major US Food & Drug Administration Safety Communications, more plaintiffs alleging they were harmed by the use of inferior vena cava filters continue to come forward, as the multidistrict litigations for two IVC filter makers continue to grow. The health risks posed by inferior vena cava (IVC) filters are well-documented, well-known, and, in some cases, well-litigated. The plaintiffs allege they suffered serious IVC filter complications because the filters were defectively designed and not properly tested to ensure safety. Patients harmed by IVC filter breakage, migration and perforation are filing personal injury lawsuits against the manufacturers of these dangerous medical devices.
IVC filters are narrow net-like medical devices implanted into the inferior vena cava of patients who cannot tolerate anticoagulant medications or other therapies designed to prevent blood clots. The filters have legs that trap blood clots and prevent them from causing deep vein thrombosis or pulmonary embolism.. But if left in too long, they can perforate the vein or detach from the vein and migrate elsewhere, causing unintended blockages or serious damage. Some filters allegedly have a risk of fracturing, migrating or perforating the patient’s veins or internal organs.
Patients say they were not properly warned about the risks associated with the medical devices. As of May 16, 2016, there were 527 lawsuits consolidated for pretrial proceedings in MDL 2641 (In Re: Bard IVC Filters Products Liability Litigation), up from 93 in March. There were also 383 lawsuits consolidated in MDL 2570 (In Re: Cook Medical, Inc, IVC Filters 1Marketing, Sales Practices and Products Liability Litigation), up from 289 in March. In one such case, a local 54-year-old IVC filter patient suffered from an abnormally rapid heart rate and was assessed with non-q-wave myocardial infarction, which is a less serious form of heart attack. Reportedly, this adverse event stemmed from filter migration, as the man’s IVC filter had shifted into the right ventricle of his heart and caused detrimental damage. Common symptoms of IVC filter migration are chest pain, fainting, abnormal heart rhythms and palpitations.
IVC filter patients have already filed nearly 1,000 lawsuits regarding filter-related injuries. One wrongful death suit was filed by a woman against C.R. Bard after the death of her husband. Court documents state that the plaintiff’s husband was equipped with a G2 IVC filter in 2006. After the procedure was completed the filter tilted, tearing his vena cava vein and failing to block clots migrating in his bloodstream. He died in September 2012 from a fatal blood clot. In addition to this particular woman, there have been many other plaintiffs who have filed suit against C.R. Bard. Allegations primarily focus on the defective devices and the possible threat to the health and well-being of patients. Currently, C.R. Bard is facing several lawsuits involving the Bard Recovery, G2 and the G2 Express IVC filters. The claims are currently being handled on a case-to-case- basis.
The allegations from NBC News (9/3/15) making the situation worse that CR Bard had in its hands a confidential study that suggested the company’s Recovery filter had an increased risk of death, fracture and movement over filters made by other companies. Despite this, Bard reportedly continued selling the Recovery for three years. The same NBC report notes that 27 deaths and 300 non-fatal events in 10 years have been linked to the Recovery filter. Complaints about the IVC filters began to surface as early as 2004, but the company continued to sell the devices and did not notify the FDA of complaints or device failures.