Michael Lin Baum, a senior managing partner at Baum Hedlund Aristei & Goldman, has handled many whistleblower and medical device cases. One such case detailed in a book involved a client who sued her neurosurgeon, Medtronic, and its subsidiaries over an allegedly defective and unsafe bone graft device called Infuse that was used in her off-label cervical fusion surgery without her full consent or knowledge of her doctor's financial ties to the manufacturer, and which led to health issues like ectopic bone overgrowth and severe pain. The case brings attention to the largely unregulated medical device industry where products are often implanted without clinical trials.

1. Lawsuit Brings Focus to an Underregulated Medical
Device Industry
Michael Lin Baum

2. Introduction
Attorney Michael Lin Baum guides Baum Hedlund Aristei & Goldman as senior managing
partner. In his work as a lawyer, he has handled a range of whistleblower cases, including
those centered on prescription pharmaceuticals. Another major focus for Michael Lin
Baum has been the medical device industry, which remains largely unregulated. In many
cases, patients are implanted with pacemakers, cardiac stents, and artificial hips that
have not undergone any clinical trials.

3. One of Baum Hedlund’s reprinted cases in this area is detailed in Jeanne Lenzer’s book
The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and
One Man’s Battle to Survive It. The case cited centers on a client who claimed, in the
lawsuit filed against her neurosurgeon, Medtronic, Inc., and subsidiaries of Medtronic,
that the bioengineered bone graft device Infuse is defective and unsafe.

4. The plaintiff alleged that her physician compelled her to use the product while
undergoing spinal surgery, due to his personal financial ties with the manufacturer.
Since she underwent off-label cervical fusion surgery, major health issues such as
ectopic bone overgrowth and severe pain have occurred, leading to the lawsuit against
Medtronic.