A partner and president at Baum Hedlund Aristei & Goldman, Michael Lin Baum is an established Southern California lawyer who provides client-centered support to people across the country. Having handled several pharmaceutical drug cases, Attorney Michael Lin Baum has navigated issues of fraudulent clinical studies and misleading advertising that led to people taking prescribed medications harmful to them.
One of Baum Hedlund Aristei & Goldman’s cases was detailed in the book “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It.” The lawsuit involved a client who sued her neurosurgeon and Medtronic, Inc. over alleged defects in the InFUSE Bone Graft Device, which led to it being dangerous and unsafe.
Approved by FDA in 2002, the genetically engineered product is for a form of spinal fusion surgery that addresses specific types of severe back pain. A decade later, a US Senate Finance Committee found that Medtronic had paid out hundreds of millions for physicians to manipulate studies and author articles favorable to the product. Beyond research, financial conflicts of interest, illegal off-label marketing, and underreporting of complications associated with InFUSE were at issue.
The woman who filed the complaint alleged many such violations, with the product promoted in a way that violated FDA regulations. This “improper off-label promotion” led to a prevalence of potentially dangerous off-label uses of InFUSE treatments. In particular, an FDA researcher found that a high percentage of adverse events associated with InFUSE were linked with off-label use.
The client further alleged that her physician recommended the off-label cervical fusion surgery she underwent due to “personal financial ties” with Medtronic. Following off-label cervical fusion surgery, she experienced ectopic bone overgrowth, accompanied by excruciating pain, which is legally actionable.
Michael Lin Baum 
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