Inferior vena cava (IVC) filters were created to treat patients with a high risk of pulmonary embolism, a life-threatening condition. In 2003, the U.S. Food and Drug Administration (FDA) approved C.R. Bard’s Recovery IVC filter. Many patients use anticoagulants (blood-thinners) to treat their risk of pulmonary embolism, but some patients are unable to take these drugs. The IVC filters were designed to provide a treatment option for these patients. The filter is implanted into the inferior vena cava and prevents embolism by catching blood clots before they can pass into the lungs. Unfortunately, shortly after the Recovery filter’s release, problems started to emerge. Over time, pieces of the filter may begin breaking off, resulting in serious injury and even death. Contact a Boston Injury Lawyer Today.
Most Common IVC Filter Injuries
Bard IVC filters are linked to multiple injuries and fatalities. Injuries range in severity and cause, but the most common include:
Severe pain
Internal bleeding
Perforations in blood vessels, tissue, and organ
Respiratory problem
Pulmonary embolism
Heart attack
Deep vein thrombosis
Death
FDA’s Fast Track Approval Process
Bard Medical officials may have known of the potential for serious and fatal injuries for over ten years. However, they failed to provide adequate warning to physicians and patients.
As a low risk, Class II medical device, Bard’s IVC filter was eligible for the FDA’s fast track approval process. This process allows ‘low risk’ medical devices to be approved without any clinical and safety testing. The ‘retrievable’ filters were intended to be temporary, however retrieval is not always possible. In fact, a 2013 study published in JAMA:Internal Medicine found that retrieval was only possible in 8.5% of patients.
Bard was the first company to manufacture this type of filter, and as a result its market share grew quickly. Early on, reports of metal struts breaking free and causing internal injuries began to emerge. Some of these injuries were fatal.
More than 900 Adverse Event Reports for IVC Filters
It wasn’t until 2010 when the public finally learned of the dangers associated with IVC filters. After receiving over 900 adverse event reports, a FDA Bard IVC filter warning was issued, reporting the risk of injury and death due to filter fracture and migration. Another updated FDA warning was issued in 2014, and Bard has received multiple warnings and threats of regulatory action in the two years since.
Altman & Altman, LLP – Boston’s Premier Injury Attorneys
If you or a loved one has been injured due to complications with an IVC filter, the injury attorneys at Altman & Altman, LLP can help. Bard’s failure to adequately warn patients of the risks associated with these devices has resulted in substantial injuries and fatalities. This level of carelessness and disregard for public health is simply unacceptable. Our skilled legal team will help you understand your options and position you for the most favorable outcome. You may be entitled to compensation for medical bills, pain and suffering, and lost wages. We have been protecting the rights of accident and injury victims for nearly 50 years. Our attorneys have successfully represented clients in countless medical malpractice, drug injury, product liability, and accident cases. Contact Altman & Altman, LLP today for a free consultation about your case.