Thousands of people receive medical attention each year for a condition called pulmonary embolism (PE), in which blood clots travel to the lungs and cause catastrophic problems. One of the most common procedures used to prevent blood clots from occurring is to surgically implant a cone-shaped filter into the inferior vena cava—the vein that takes blood from the lower half of the body back to the heart. The filter acts like a trap for the clots and dramatically reduces the risk of PE, which can be a life-threatening condition.
This procedure is performed in hospitals around the Houston area every day. While the technique has surely saved many lives, serious questions are being raised about the safety of one particular filter, the Bard IVC Recovery filter, sold by C.R. Bard. According to a recent report, serious side effects, such as perforation, migration, and even death, have been linked to the popular product.
An NBC News investigation revealed that at least 27 deaths were caused by the Recovery filter over a decade, and approximately 300 patients suffered from serious conditions because of the filter.
Dodi Froehlich received a filter after a serious car accident put her at risk for developing blood clots. Four months after installation of a Recovery filter, she suffered from a major headache, and then lost consciousness. Froehlich began flat-lining in the ambulance and tests revealed that a piece of the filter had broken off and pierced her heart. Froehlich underwent emergency open-heart surgery to repair the problem and fortunately, surgeons were able to find the faulty piece and remove it before Froehlich lost her life. However, other victims aren’t always so lucky.
Gloria Adams received the Recovery filter after she suffered from a brain aneurysm. A week after she was discharged from the hospital, Adams died. An autopsy revealed that instead of stopping a blood clot, a clot actually pushed the filter inside Adam’s heart and punctured it, causing her to lose her life.
After problems with the Recovery began to surface, Bard hired the public relations firm Hill and Knowlton, which devised a crisis management plan. The firm warned that “unfavorable press” could lower stock prices and ruin Bard’s reputation. After safety concerns came to light regarding the filter, Bard hired an outside doctor to help launch an independent, confidential study about its filter. The doctor found that Recovery had higher rates of relative risk, including filter fracture, death, and movement, than other similar filters. Additionally, the doctor concluded that “further investigation…is urgently warranted.”
Instead of recalling the filters after the deaths and injuries, C.R. Bard sold about 34,000 more over a three-year period, before releasing a modified version of the filter, called the G2.
Getting the Recovery Filter cleared by the FDA wasn’t an easy process for C.R. Bard. In fact, the FDA rejected Bard’s first application for the filter. Only after hiring a regulatory specialist to consult on the filter did the company actually receive approval for the medical device.
Despite the evidence of the filter’s risks, the company maintains that Recovery is effective. In a statement, Bard says all of its filters have been “appropriately cleared by the FDA based on required and accurate documentation and that when used as instructed, they demonstrate ‘significant benefits to patients’.”
You put your life in the hands of medical professionals and trusted that they only used products that were safe. Instead, you may have suffered serious consequences because of a faulty device, like the Recovery filter. Not only is your health compromised when dangerous products are used, but your quality of life is affected, as well.
You likely lost time away from work and have thousands of dollars in medical bills because of the filter. Fortunately, you may be able to hold the people responsible for your injuries accountable for their negligence. We encourage you to speak to a legal professional about your situation to learn more about rights today.