FAQ

Dr. Sharlin has worked on cases involving drugs, biologics, and medical devices spanning 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.

Dr. Sharlin strengthens litigation teams by explaining relevant FDA regulations and how they apply to the case, clarifying the FDA-related facts behind his opinions, identifying impactful discovery requests, developing probing deposition questions, and pinpointing key regulatory details in transcripts.

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. 

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.

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.

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.

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

No. Dr. Sharlin has never had an opinion excluded because of a Daubert challenge, across 50+ cases, 22+ expert reports, and 20+ depositions with 5 trial testimonies. His opinions are grounded directly in FDA regulations, guidance, and safety-database evidence, which keeps them methodologically sound and admissible.

Dr. Sharlin covers the full range of FDA-regulated products: prescription and OTC drugs, biologics, and medical devices (including 510(k), PMA, IDE, and De Novo pathways). His case experience spans product liability, failure-to-warn, off-label promotion, data integrity, and regulatory-compliance disputes involving these product categories.

Fees are discussed directly with counsel once Dr. Sharlin has confirmed the case fits his expertise call (410) 231-8900 or email josh.sharlin@fda-expert.net for current rates. There’s no cost to have that initial conversation, and he’ll tell you plainly if a case falls outside his area rather than take on work that doesn’t fit.

Dr. Sharlin holds a Ph.D. in the biological sciences and served as an FDA drug reviewer before spending 25+ years as an independent FDA regulatory consultant to 100+ companies. That combination regulator-side and industry-side experience, plus a scientific doctorate is what courts look for in an FDA regulatory expert and is the same standard cited by expert-witness referral services when vetting candidates.

Yes. Dr. Sharlin is based in Washington, D.C., but works with litigation teams nationwide. FDA regulatory issues are governed by federal law, so his opinions apply regardless of which state or federal court is hearing the case.

As early as possible ideally before discovery requests go out. Early involvement lets him shape discovery around the FDA issues that matter most, flag weaknesses in the case before deadlines lock counsel in, and pull MAUDE/FAERS safety data early enough to inform strategy rather than just support a report already in progress.

A consulting expert advises counsel behind the scenes and is not disclosed to the other side; a testifying expert is disclosed, writes a formal report, and can be deposed and called at trial. Dr. Sharlin serves in both roles depending on what the case needs some engagements start as consulting-only case assessments and expand to testifying work once the FDA issues are confirmed to be central to the case.