Unregulated Off-Label Medical Devices - A Typical Example
A distinguished legal executive based in California, Michael Lin Baum graduated summa cum laude with a BA in law and a JD from the University of California, Los Angeles. As a managing partner at Baum Hedlund Aristei & Goldman, Michael Lin Baum concentrates his legal practices on wrongful death and personal injury cases associated with erroneous medical devices and defective drugs. Data from John Hopkins revealed that errors in medical interventions are the third leading cause of death in the United States. A significant proportion of these errors result from harmful implant devices such as pacemakers, cardiac stents, and artificial hips. Many of these implants did not undergo comprehensive clinical trials and FDA scrutiny before getting into the market. A typical example of these life-threatening situations occurred with a product by Medtronic. Baum Hedlund Aristei & Goldman's filed personal injury claims on behalf of clients against the medical device manufacturer. Medtronic was sued for allegedly producing lethal bone-graft devices. Their product, Infuse® was used by neurosurgeons in spinal surgical procedures to provide mechanical support in between vertebral bones. Following the procedure, some patients suffered bone overgrowth in the spinal area where the device is used. This comes with a debilitating pain that qualifies a serious personal injury claim. According to claims, many Medtronic devices were promoted for non-approved off-label use. Medtronic sought legal immunity but the court ruled that medical device manufacturers who violate federal law and promote their devices for non-approved surgeries should be held accountable for any injuries innocent patients suffer as a result of such non-approved surgeries.
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Unregulated Off-Label Medical Devices - A Typical Example
- 1. UNREGULATED OFF-LABEL MEDICAL DEVICES - A TYPICAL EXAMPLE Michael Lin Baum
- 2. INTRODUCTION A distinguished legal executive based in California, Michael Lin Baum graduated summa cum laude with a BA in law and a JD from the University of California, Los Angeles. As a managing partner at Baum Hedlund Aristei & Goldman, Michael Lin Baum concentrates his legal practices on wrongful death and personal injury cases associated with erroneous medical devices and defective drugs.
- 3. Data from John Hopkins revealed that errors in medical interventions are the third leading cause of death in the United States. A significant proportion of these errors result from harmful implant devices such as pacemakers, cardiac stents, and artificial hips. Many of these implants did not undergo comprehensive clinical trials and FDA scrutiny before getting into the market. A typical example of these life-threatening situations occurred with a product by Medtronic. Baum Hedlund Aristei & Goldman's filed personal injury claims on behalf of clients against the medical device manufacturer.
- 4. Medtronic was sued for allegedly producing lethal bone-graft devices. Their product, Infuse® was used by neurosurgeons in spinal surgical procedures to provide mechanical support in between vertebral bones. Following the procedure, some patients suffered bone overgrowth in the spinal area where the device is used. This comes with a debilitating pain that qualifies a serious personal injury claim.
- 5. According to claims, many Medtronic devices were promoted for non-approved off-label use. Medtronic sought legal immunity but the court ruled that medical device manufacturers who violate federal law and promote their devices for non-approved surgeries should be held accountable for any injuries innocent patients suffer as a result of such non-approved surgeries.