Are Medical Devices a Part of Medical Malpractice?

Posted on July 14, 2014 by Shapiro Law Group

Yes, medical devices can be a part of medical malpractice. Doctors and other healthcare personnel use medical devices every day, and the link between medical devices and negligence on the part of doctors usually constitutes a tandem relationship. The Cancer Letter recently published a story that details just how medical devices can play into medical malpractice.

On October 17, 2013, a patient underwent a “minimally invasive” hysterectomy, a routine procedure, which was performed with a surgical instrument called a “power morcellator.” A hysterectomy is the surgical removal of the uterus, notably for reproductive system cancers and other benign conditions. A power morcellator is a tool that is used to divide and remove large masses of tissues during surgery.

What the power morcellator ended up doing was spreading a malignant tumor throughout the patient’s abdominal pelvic cavity. So, sue and win a medical malpractice verdict, right? No. As the unsuspecting patient battled for her life over the ensuing months, her family’s despair was compounded when they learned that there was no obvious target for legal action.

Medical malpractice claims usually involved a deviation from the standard practice. However, power morcellation is the standard of care and seems to work just find. The key word is “seems.” Minimally invasive power morcellation is performed on about 100,000 women per year in the U.S. With one in 350 women that undergo hysterectomies having unsuspected malignant cancers, the number of potential cases is unsettling.

Luckily, there might be some hope. The patient and her family’s push against how medical devices are regulated have yielded some positive results. On April 17, the U.S. Food and Drug Administration (“FDA”) issued an advisory that discouraged the use of power morcellation, and this month an FDA panel will meet to discuss power morcellation.

Medical malpractice is not simply limited to what a physician does, it can also include how physicians use instruments and if the instruments were defective or not. Power morcellators carry a risk that was not properly understood at first and about which there are still questions.

If you have undergone any procedures with a power morcellator or just have questions, then you should seek the advice of a qualified medical malpractice attorney. Contact us for more information.

Did You Know: “Wrongful death” is the most commonly alleged medical malpractice injury.

Shapiro Law Group – Medical Malpractice Attorneys Serving the Tampa Bay Area



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