Bard Hides IVC Filter Side Effects, Receives Warning from FDA
For patients who have developed pulmonary embolisms or deep vein thrombosis in the past and continue to be at risk for developing them in the future, an inferior vena cava (IVC) filter can be implanted to reduce the risk of blood clot migration. This cone-shaped device is implanted just below the kidneys, in the inferior vena cava, the body’s largest vein. Its purpose is to capture blood clots and prevent them from traveling to the heart and lungs, where they can cause chest pain, breathing difficulties and even death.
An IVC filter can be a lifesaver for many patients, but only if it is properly designed/manufactured. Unfortunately, many Bard IVC filters have caused serious injuries due to design defects. These filters are made of fragile, metal parts that can fracture or break off, puncturing nearby blood vessels and organs. In fact, one patient suffered severe injuries to the heart, due to Bard IVC filter. The patient sued the company, and a settlement was reached earlier this year. Bard has attempted to quietly settle these lawsuits, therefore, full settlement details are unknown.
Currently, there are more than 200 defective IVC lawsuits filed against Bard. The Food and Drug Administration began warning patients in 2010 about the dangers of using IVC filters. Since that time, the FDA has received hundreds of adverse event reports of the filters breaking apart and migrating in patients’ bodies.
Manufacturers are required to report adverse events resulting from a drug or medical device. Bard has failed to consistently report adverse events, instead, choosing not to report deaths and serious injuries caused by the IVC filters. In one case, the arms of the filter detached, causing the patient’s death. Bard classified the event as a “malfunction,” rather than a death. Other reports were misfiled or failed to state pertinent information.
In addition, many of these reports were filed after the 30-day deadline for manufacturers to report adverse events to the FDA. The FDA had previously warned Bard about this and other violations, such as manufacturing a product without proper approval. The FDA has now issued Bard a warning letter, asking that all violations be fixed.
The defective medical device attorneys of Nadrich & Cohen, LLP are currently investigating claims of serious injury or death resulting from Bard IVC defects. If you or a loved one has suffered a serious injury following implantation of the IVC device, call our attorneys now for a free consultation.