FAQ
Frequently Asked Questions
What makes you an outstanding expert witness?
Dr. Sharlin’s differentiating skills are the depth and breadth of his skills including:
- Experience as an FDA drug reviewer.
- Regulatory consultant to 100+ companies.
- Ph.D. in the biological sciences.
- Software development fluency. Before being hired as a statistical reviewer at FDA, Dr. Sharlin was Director of Hotel Customer Information Systems at Marriott International. As a result, he has insight into the management and analysis of clinical trial data and the preservation of data integrity.
- Served as a regulatory advisor to senior leadership in the Department of Defense regarding 18 FDA-regulated products designed for defense against chemical or biological weapons.
- Extraction, manipulation and analysis of information in drug and medical devices safety databases maintained by a company or by FDA (MAUDE for medical devices and FAERS for drugs).
- Written and critiqued, protocols, statistical analysis plans, data collection plans, standard operating procedures, and clinical study reports.
- Written and critiqued many types of FDA submissions including 510(k), IDE, PMA, IND and NDA.
- Experienced auditor. Dr. Sharlin has audited pharmaceutical and medical device companies, CROs, software vendors, and clinical sites. Dr. Sharlin knows how and where compliance problems are likely to occur and how to find them.
What types of cases have you worked on?
Dr. Sharlin has worked on a wide range of cases involving drugs, biologics, and medical devices. His experience spans matters related to death or injury, patent infringement, insurance and contract disputes, criminal allegations, failure-to-warn claims, trade secrets, mergers and acquisitions, wrongful termination, non-compete agreements, stock fraud, software development, data integrity, arbitration, and off-label use.
What specific benefits do you bring to a litigation team?
Dr. Sharlin strengthens litigation teams by informing them about relevant FDA regulations and explaining their application to the case. He also clarifies FDA-related facts that support his expert opinions. In addition, he identifies impactful discovery requests, develops probing deposition questions, and pinpoints key regulatory details in transcripts.
Are you available for early case assessment or consultation before litigation?
Yes. Before accepting a case, Dr. Sharlin ensures the case-specific FDA issues fall squarely within his expertise by reviewing the complaint, or having a call with the litigation team. In failure-to-warn cases, he can quickly analyze the FDA safety databases, MAUDE (for devices) or FAERS (for drugs) to assess the frequency of a reported injury.
Do you testify for plaintiffs or defendants?
Dr. Sharlin has worked for both plaintiff and defense attorneys. While most of his cases have supported plaintiffs, he has also worked for the defense representing surgeons, insurance companies, and pharmaceutical companies. His opinions are based solely on the facts —never on which side retains him.
Are you effective in front of a judge, jury or arbitration panel?
Over 40,000 professionals have paid to attend Dr. Sharlin’s presentations on more than forty FDA-related technical and compliance topics. Drawing on decades of experience developing and explaining FDA regulations, he delivers clear, authoritative testimony that engages and persuades judges, juries, and arbitration panels.
Do you personally do all the work?
Dr. Sharlin personally locates and reads the medical and scientific literature important to developing facts for a case. He also identifies and evaluates relevant FDA regulations and guidance, and writes the entire expert report. He uses outside SAS programmers for data analysis but defines all software requirements and reviews the SAS code, drawing on his five years of experience teaching programming for SAS Institute.
How can counsel retain Dr. Sharlin or request a case review?
The easiest method is to call his cell phone (410.231.8900). His office is on Eastern Time. Otherwise, send an email to josh.sharlin@FDA-expert.net. There is a contact form on the web site, SharlinConsulting.com
Sharlin Consulting, LLC.
Joshua Sharlin, PH.D
josh.sharlin@fda-expert.net
Cell: (410) 231-8900
Washington, D.C.