What Makes an Effective FDA Expert Witness?
When it comes to litigation involving pharmaceuticals, biotechnology, or FDA-regulated products, an expert witness must do more than recite regulations. An FDA expert witness must translate complex science and regulatory language into compelling courtroom testimony.
Here’s what separates the best from the rest:
Deep Regulatory Knowledge Is Non-Negotiable
The FDA’s framework is complex, nuanced, and always evolving. Whether a case involves failure to warn, misbranding, or product recall, a qualified expert must stay current with evolving FDA statutes, guidance documents, and case law precedents.
Dr. Joshua Sharlin has decades of experience with FDA protocols, investigational new drugs (INDs), new drug applications (NDAs), biologics, and combination products—making him an invaluable resource when accuracy matters.
Experience with Litigation Across Industries
A strong FDA expert witness isn’t just a regulatory advisor—they’re a legal asset. The ideal expert has testified in a range of disputes including patent infringement, wrongful termination, and non-compete clause litigation, especially within pharmaceutical and medical device sectors.
Dr. Sharlin has supported law firms, in-house counsel, and government clients through high-stakes disputes across the country.
Clear, Concise, and Persuasive Testimony
It’s not enough to understand the science—the best experts explain it simply and authoritatively. Dr. Sharlin is known for his ability to connect with judges and juries, offering not just expertise but clarity.
Meet Dr. Joshua Sharlin: Your FDA Expert Witness
If you’re looking for an FDA expert who blends academic knowledge with real-world authority, Dr. Joshua Sharlin stands at the top of his field.
Credentials You Can Trust
Dr. Sharlin holds a Ph.D. in Biochemistry from the University of Chicago and has worked with major players in the life sciences, including biotech startups, global pharmaceutical firms, and regulatory agencies. His resume includes work on over 100 legal cases, with successful outcomes ranging from dismissed claims to favorable settlements.
Former FDA Official Turned Trusted Consultant
Having previously worked inside the FDA, Dr. Sharlin brings insider knowledge to every case. He understands the internal workings of drug review divisions and compliance protocols. This gives his testimony unique credibility and strategic advantage in courtroom cross-examination.
Decades of Real-World Experience in Pharma and Biotech
His clients appreciate that he’s not an ivory-tower academic. Dr. Sharlin has led regulatory teams, conducted due diligence for acquisitions, and designed compliance strategies. His perspective spans science, business, and regulation, making him uniquely equipped to support attorneys in complex litigation.
Case Applications: How Dr. Sharlin Supports Key Legal Challenges
Expert Witness for Failure to Warn Lawsuits
In failure to warn cases, plaintiffs often claim that a pharmaceutical or biotech company didn’t adequately disclose known risks. These cases hinge on FDA submission records, labeling compliance, and internal safety protocols.
Dr. Sharlin provides forensic-level analysis of submission timelines, adverse event reporting, and FDA labeling decisions. His insight helps determine whether a warning was sufficient, legally defensible, or in violation of FDA expectations.
Strategic Testimony in Patent Infringement Cases
Patent litigation in the pharmaceutical sector often involves technical disputes over molecular structure, mechanisms of action, or biosimilarity standards.
Dr. Sharlin has consulted on numerous Hatch-Waxman litigation and ANDA (Abbreviated New Drug Application) disputes, serving both brand-name and generic manufacturers. His ability to explain how FDA approval pathways intersect with patent law can sway judges and juries in high-stakes IP litigation.
Consulting for Non-Compete and Wrongful Termination Disputes
Pharma professionals often move between competitors. When they do, companies may pursue non-compete or wrongful termination litigation.
Dr. Sharlin helps courts understand the proprietary nature of regulatory filings, investigational trial data, and strategic regulatory plans—context that’s vital for assessing intellectual property risk or trade secret misappropriation claims.
A Crucial Asset for Mergers and Acquisitions
Whether you’re acquiring a small biotech firm or selling a contract manufacturing organization, regulatory risk is front and center.
Pre-Deal FDA Compliance Reviews
Dr. Sharlin can evaluate the regulatory health of an acquisition target before closing. He performs gap analyses on past FDA inspections, reviews clinical trial protocols, and flags submission issues that may create future legal or compliance risks.
Risk Assessment and Liability Mitigation
Through expert analysis, Dr. Sharlin helps clients quantify potential liabilities related to past FDA violations or compliance deficiencies. This insight is essential for negotiating indemnification or purchase agreement language.
Navigating Regulatory Red Flags Before Closing
Companies trust Dr. Sharlin to flag red flags before they become costly litigation. From 483 observations to warning letters, he helps buyers and sellers approach M&A with eyes wide open.
FAQs About Working with an FDA Expert Witness
When Do You Need an FDA Expert Witness?
You should consider hiring an FDA expert witness when litigation involves:
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Drug or device approval processes
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Labeling and warning disputes
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Regulatory compliance investigations
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Patent challenges involving FDA-reviewed products
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Employment law cases with regulatory implications
What Is the Typical Process and Timeline?
Most cases follow this timeline:
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Initial case review and conflict check
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Case-specific document analysis
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Deposition preparation and support
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Expert report drafting
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Testimony (deposition and trial)
Dr. Sharlin is known for fast turnarounds and clear communication, even under tight court deadlines.
What Sets Joshua Sharlin Apart from Other Consultants?
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Unique blend of FDA insider experience and legal consulting
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Proven success in high-stakes litigation
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Respected for clarity in depositions and trials
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Trusted by top law firms nationwide
Why Choose Joshua Sharlin for Your FDA Expert Witness Needs?
Here’s the deal: not all expert witnesses are created equal. When your case involves regulatory nuance, scientific complexity, and legal risk, you need an expert who’s done it all—from inside the FDA to federal courtrooms.
Dr. Joshua Sharlin provides:
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Expert testimony grounded in real-world regulatory experience
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Tailored insights for cases involving failure to warn, wrongful termination, patent disputes, and more
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End-to-end litigation support from early discovery to trial
Ready to Work with a Trusted FDA Expert Witness?
If you’re facing a complex litigation case or high-stakes M&A deal, don’t leave your expert witness choice to chance.
Book a consultation with Dr. Joshua Sharlin today to explore how he can help you build a winning legal strategy.
👉 Visit Sharlin Consulting or call directly to discuss your needs with confidence.
