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Williams DeClark Tuschman Co., L.P.A. Leads Lawsuit Against FDA for Failure to Report Surgical Stapler Injuries

On Behalf of | Mar 13, 2019 | Firm News

Our firm, Williams DeClark Tuschman Co., L.P.A., is proud to represent Mark Levering, 62, who almost died at the hands of a malfunctioning surgical stapler. When the stapler misfired during his liver surgery, staff had to perform CPR for 22 minutes and Mark awoke from his coma unable to walk to recognize his wife and son. Despite denying allegations of wrongdoing, our legal team is working tirelessly to hold the responsible parties accountable–as Mark’s story is one of many. Tens of thousands of patients have become victim to the Food and Drug Administration’s lack of transparency at the expense of innocent people. After witnessing a surgical stapler fail and lock up in front of his eyes, Dr. Douglas Kwazneski did what any medical professional would do and referred to the FDA. He was shocked with what he found and since sought to expose the FDA’s duplicity and negligence. Following intensive research, Kwazneski was forced to admit, “I don’t want to sound overdramatic here, but it seemed like a cover-up.” Investigations have revealed various medical device companies have been privately filing reports involving injuries or other malfunctions to the FDA. The FDA has allowed these reports to quietly avoid public scrutiny–until now. Unbeknownst to medical professionals, the FDA had granted these manufacturing companies a hidden database in which to file injury or malfunction reports. When Mark’s wife, Doris Levering, learned of this life-threatening exemption on the FDA’s part, she stated: “Why would this information not be made available to doctors? The true information–I mean the actual numbers…People’s lives are at stake. Mark’s life will never be the same.” This shocking Kaiser Health News investigation revealed over 1.1 million incidents have been directed to an internal database as opposed to MAUDE. This secret repository, virtually unknown to doctors and medical professionals, contained reports most commonly for surgical staples. When functioning properly, surgical staples make minimally invasive surgeries possible. At their worst, they can result in a patient bleeding to death. Public records fail to show countless instances of malfunction or harm, despite an outpouring of thousands of lawsuits from injured patients. In the most tragic cases, these unregulated exemptions are direct causes of permanent damage or wrongful death. As of 2019, there are over a million reports only accessible to the FDA. While transparency is the administration’s new motto, receiving a response to a report may take up to 2 years. Despite the FDA’s public pledges for improvement in health safety, it has amassed a controversial reputation for its special exceptions with dangerous medical devices. To learn more about this major development, read the Kaiser Health News article here.

Contact Our Trusted Toledo Personal Injury Attorneys Today

If you or a loved one has been a victim of a malfunctioning medical device, or any medical procedure which may have been prevented with due diligence, we at Williams DeClark Tuschman Co., L.P.A. want to fight for you. Our Toledo personal injury lawyers are passionate about advocating on behalf of those who have been hurt at the hands of another’s misconduct or negligence. We don’t protect these massive systems and organizations–we protect you. If you are interested in scheduling an initial consultation with a member of our firm you may do so by calling (419) 719-5195.