Patients who become seriously injured by defective medical devices have a clear legal recourse: They can bring a personal injury lawsuit against the manufacturer, or even against the surgeon who first implanted the faulty device. In the case of surgical staplers, however, many people may have been hurt without receiving the justice they deserve, due to a secret FDA exemption for surgical stapler manufacturers.
At Rheingold Giuffra Ruffo & Plotkin LLP, we help people who have been injured because of manufacturer negligence – and our experienced product liability attorneys never back down from a challenge. If you believe that a surgical stapler led to catastrophic injuries or the loss of a loved one, our New York team can take your claim all the way to court. Bringing over 30 years of experience and a strong commitment to justice, our attorneys can handle even the most complex medical device claim and increase your chance of recovery.
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Surgical staples are meant to be a healing aid, rather than a source of additional harm. Used in both internal and external procedures to seal wounds under high tension, surgical staples have the power to save lives when designed and used correctly. However, when they backfire, the results can be devastating, and range from internal bleeding and infection to death.
Why do surgical staples cause injuries? Here are the most commonly cited reasons:
If a surgeon fails to exercise due diligence on the operating table, or if the manufacturer of a life-saving medical device ignores key product defects, our legal system allows injury victims to hold them accountable. Of course, in order to do that, there must also be clear evidence that a product is prone to causing injuries.
In the case of surgical staplers, it has often been difficult for victims to receive justice, due to the fact that only 84 malfunctions had ever been reported in the public FDA database. Then, in March 2019, the FDA was forced to reveal that they had a separate, secret database just to track these stapler malfunctions, after Kaiser Health News published a full report online.
According to that KHN report, thousands of device malfunctions were intentionally hidden from the public, with up to two-thirds of all surgeons admitting that they either personally witnessed a stapler malfunction, or had heard of a colleague who experienced it. In all, more than 10,000 surgical stapler malfunctions – many of which caused the patient’s death – were tracked through this secret FDA system.
In withholding crucial information from physicians, the FDA may have helped the surgical stapler companies to avoid scrutiny – and as a result, allowed countless patients to suffer life-altering injuries. Now that the secret database has become common knowledge, many victims are choosing to pursue product liability claims against the two main stapler manufacturers: Medtronic and Ethicon.
Nothing can ever make up for the pain and loss of your injuries, but by holding these manufacturers accountable, you may be able to find some degree of peace. To that end, our compassionate New York surgical stapler attorneys are ready to fight for justice, and secure the maximum compensation for your claim.
Have you been injured by a defective surgical stapler? Call (212) 684-1880 for a free consultation at Rheingold Giuffra Ruffo & Plotkin LLP.