Joshua Sharlin, Ph.D.

Expert Witness: FDA Regulations

Former FDA reviewer
Expert witness experience: Cases-37, Expert reports-16, Depositions-8, Testimony-1, Successful Daubert challenges-0
Experience: Regulatory consultant (25 years), expert witness (10 years)

Expert Witness Cases

1. Explain how a generic drug company’s failure to meet FDA’s regulatory requirements for supplying a Medication Guide with a drug prescription supports a legal case for failure to warn.

2. Analyze FDA’s drug safety database to show there was significant evidence of serious cardiovascular events among men taking hormone replacement therapy.

3. Support a medical device company’s claim for monetary damages by showing how infringement of their patent solved a regulatory compliance problem of the defendant.

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

5. Explain how a drug company’s manufacturing compliance failure negated their business loss insurance claim made after physical damage to their manufacturing facility.

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

7. Conduct an FDA compliance review of a medical device company’s actions after the installation of their implantable pulse generator (intended to relieve pain) caused harm.

8. For a low risk Class I medical device, identify the company’s regulatory failures related to safety that resulted in a death.

9. Write a report explaining why the Warning Section in the label for a generic version of sulindac was deficient.

10. Write a report confirming a drug manufacturer’s processes for establishing the stability of a drug product met FDA’s compliance requirements.

11. Review a clinical study intended to compare the effectiveness of two drugs. Show the study’s design was manipulated to mask the weakness of one drug over the other.

12. Find weaknesses in a defense expert’s report on the adverse event reporting of fentanyl.

13. Evaluate FDA compliance in reporting adverse event information about Actos.

14. Deposed about the responsibilities of an Institutional Review Board in a wrongful firing case.

15. Testify for the defendant in a fertility clinic damages case. Explain the process and predictability of FDA approval of a drug under development.

16. Analyze the content of a drug IND submission to identify trade secret content.

17. Identify FDA regulatory deficiencies in the adverse event reporting of a breast cancer drug and describe the resulting deficiencies in the drug’s label.

18. Analyze the adverse event reporting for a drug that treats Attention Deficit Hyperactivity Disorder (ADHD) to determine if the drug’s label meets FDA regulatory requirements.

19. For a schizophrenia drug, analyze the growing body of scientific literature about the drug and determine if the company’s updates to the drug label’s safety information were FDA compliant.

20. Analyze FDA’s medical device safety database to show a company failed to report incidents about their medical device resulting in death.

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

Sharlin Consulting

Joshua Sharlin, PhD

Cell: 410-231-8900

(Washington, D.C.)