A product intended to prevent blood clots for those at high risk may in fact be extremely dangerous, and questions are being raised about manufacturers’ knowledge of those risks. We’re talking about IVC filters – short for inferior vena cava blood clot filters.
A recent report by NBC News has shed light on problems with the devices, which have reportedly been connected to 27 deaths and more than 300 adverse effects, some of which were life-threatening.
That’s according to government data on just one of these devices, known as the “Recovery” model, sold by C.R. Bard, a medical products firm.
The news agency exposed previously confidential company records that may prove the company knew its IVC filters, intended for those who can’t take anticoagulants, were defective.
The records show that the firm hired a public relations company for the express purpose of coping with some type of fallout that might affect its reputation and stock prices. That suggests the company knew the ball was about to drop on some big issue.
Beyond that, however, the company hired a medical doctor to conduct research into the safety of the device. That study indicated the Recovery device put patients at a greater risk of the filter fracturing and pieces of the filter migrating to key organs (i.e., the heart or lungs) and perforating those organs, resulting in death. The conclusion of the study indicated the company should conduct more investigation, and it even went so far as to suggest it might be prudent to initiate a recall. But the company took no action.
It did make some modifications to the device, but it never recalled the old ones. It’s estimated about 30,000 of the devices were sold before modifications were made. The updated version is called the G2. It’s estimated about 20,000 people still have the old device inside them.
Later studies would show the old recovery filter fractured about a quarter of the time. Meanwhile, even the newer version failed about 12 percent of the time.
But this wasn’t even the first time the company had issues with the device. Back in 2002, the U.S. Food & Drug Administration denied clearance to the company for its filters. So it hired a regulatory specialist to help. An application for clearance with her name and signature on it is on file with the FDA, which granted approval to the drug shortly thereafter. However, that regulatory specialist was just interviewed by NBC. She says she never signed that document. In fact, she says she was so concerned about the safety of the device, she informed the company about her reticence, refused to support the request, and even notified the FDA. However, she left Bard by that point and wasn’t sure whether any action was taken.
Unfortunately, the product still ended up on the market.
If you have suffered an adverse medical consequence as a result of the implantation of an IVC filter in Florida or D.C., contact our experienced product liability lawyers to learn more about how we can help.
The Ferraro Law Firm handles claims resulting from defective products or dangerous pharmaceuticals. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami and Washington, D.C.
Did Blood-Clot Filter Used on Thousands of Americans Have Fatal Flaw? Sept. 3, 2015, By Tim Sandler, Stacey Naggiar and Stephani Gosk, NBC News
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