Sharlin Consulting, LLC

Joshua Sharlin, Ph.D.

Expert Witness: FDA Regulations
FDA Regulatory Consultant (25 Years)
Expert Witness (10 Years)

Expert Witness Cases

Medical Device Death & Injury
For a low risk Class I medical device, I identified the company’s regulatory failures related to safety that resulted in a death.

I used custom software to analyze FDA’s medical device safety database to show a company failed to report incidents about their medical device resulting in death.

Drug Death & Injury
I used custom software analyze FDA’s drug safety database to show there was significant evidence of serious cardiovascular events among men taking hormone replacement therapy.

I testified in the New York State Supreme Court for the defendant in a monetary damages case. I explained to the judge and jury the process and predictability of FDA approval of a drug under development.

I Identified FDA regulatory deficiencies in the adverse event reporting of a breast cancer drug by a drug company and described the resulting deficiencies in the drug’s. label.

I analyzed the adverse event reporting for a drug that treats Attention Deficit Hyperactivity Disorder (ADHD) and determined the drug’s label did not meet FDA regulatory requirements.

Hip Implant
For a hip implant, I Identified pre- and post-approval actions and inactions by the medical device manufacturer that were noncompliant with FDA’s regulatory requirements.

For a hip implant, I described the medical device manufacturer’s lack of FDA compliance in their efforts to obtain a 510(k) approval

Medication Guide
I explained how a generic drug company’s failure to meet FDA’s regulatory requirements for supplying a Medication Guide with a drug prescription supporting a legal case for failure to warn.

I supported a small medical device company’s claim for monetary damages by showing how infringement of their patent solved a regulatory compliance problem of the defendant, large medical device company.

Insurance Claim
I explained how a drug company’s manufacturing compliance failures negated their business loss insurance claim made after physical damage to their manufacturing facility

Trade Secret
I analyzed the content of a drug IND submission to identify trade secret content.

I explained how achieving drug development milestones triggered a disputed $100 million dollar payment in a merger agreement between two companies.