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The Unregulated Medical Device Industry

Michael Lin Baum

· Medical Device
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Attorney Michael Lin Baum leads an award-winning legal team as the president of Baum, Hedlund, Aristei & Goldman. His work as a lawyer litigating thousands of personal injury claims brings Michael Lin Baum in touch with the best and worst the medical industry has to offer.

Some firm’s lawyers' experiences were published in books, such as “The Danger Within Us.” It exposes the lack of regulations in medical devices across the United States. Like grafts, pacemakers, artificial hips, and stents, a majority of life-saving devices never go through a formal peer-reviewed clinical trial to determine their safety and effectiveness.

For example, a bone graft device called Infuse from Medtronic has led to severe complications in one of Baum Hedlund’s clients, who has since suffered extreme pain and ectopic bone growth. FDA research published by Emily Woo, M.P.H., concluded that 99.5% of the device’s adverse effects were reported from off-label use, which makes up for over 85% of Infuse’s sales. The industry is fraught with similar cases of unregulated and poorly tested devices that can harm people’s bodies. Unfortunately, this demonstrates that political and economic ties often outweigh patient safety and concerns.