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Joshua Sharlin, Ph.D.
Former FDA reviewer. FDA Expert Witness - cases with Drugs, Devices, Patents, Mergers, Business Interruption. Authority in Software, Data Integrity, Vaccine Compliance and GCP auditing.
Joshua Sharlin, Ph.D. is an FDA regulatory expert witness and compliance consultant with extensive experience in the pharmaceutical and medical device industries. Here are some key details about Dr. Sharlin:
Background and Expertise
Dr. Sharlin holds a Ph.D. in Physiology from the University of Georgia.47 He is the Principal Consultant at Sharlin Consulting, LLC, where he provides FDA regulatory expertise and expert witness services.67
Professional Experience
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Former FDA Drug Reviewer: Dr. Sharlin previously worked as a drug reviewer at the Food and Drug Administration (FDA).34
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Extensive Consulting Experience: He has over 25 years of experience as an FDA compliance consultant.3
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Expert Witness: Dr. Sharlin has served as an FDA regulatory expert witness for 10+ years, participating in over 50 cases.56
Areas of Expertise
Dr. Sharlin specializes in:
- FDA regulations and compliance
- Drug and medical device safety
- Biological sciences and statistics
- Software development and data integrity
- Technical writing and education on FDA-related topics12
Notable Achievements
- Trained over 50,000 people from FDA-regulated companies on regulatory topics.13
- Developed and presented more than 40 FDA-related technical and compliance classes.3
- Skilled at explaining complex FDA-related information to judges and juries.1
Expert Witness Work
Dr. Sharlin has provided expert testimony in cases involving:
- Death or injury caused by drugs, biologics, or medical devices
- Patent disputes
- Insurance claims
- Wrongful termination
- Trade secrets
- Product labeling
- Mergers and acquisitions15
His experience includes 50 cases, 22 expert reports, 15 depositions, and 3 testimonies. He has never been successfully Daubert challenged.6
Highlights
Implantable Medical Devices, New Info from FDA Attorneys Must Know
In a 15Mar2019 statement on their Web site, FDA summarizes new info about materials sciences related to medical devices. This content affects strategies attorneys should use in implantable or insertable medical device cases involving: • breast implants • metals in devices (e.g. Essure birth control & hip implants) • Animal materials in devices (e.g. heart valves made from pig tissue) • Drug delivery systems and biosensors using graphene.
FDA acknowledges that implantable or insertable devices can initiate a biological response in patients causing pain, chronic fatigue, cognitive issues and other symptoms adversely affecting quality of life.
FDA is expanding their knowledgebase about these devices with new information that includes:
• Guidance documents
• Advisory panel meetings
• Performance standards and testing protocols
• Medical device registries
• Post market surveillance studies.
Legal issues can be caused by incomplete knowledge about the above items creating errors in safety reporting, complaint handling, labeling, or submission content. The result can be a failure to warn, or a product that is adulterated or misbranded.
#lawsuits #medicaldevice #personalinjury #essure #hipimplant #FDA
Discovery & FDA Regulations: Advice to Attorneys
My assistance to attorneys during discovery in cases involving FDA regulations has two parts. First, for the legal and regulatory aspects, the cornerstone is the requirement that companies follow FDA mandates as defined in the Code of Federal Regulations (CFR). It is this documentation required by FDA to prove compliance, that should be sought during discovery. Attorneys should follow three steps: (1) Identify FDA-related legal issues, e.g. failure to warn patients. (2) Determine the relevant regulations, e.g. medical device safety reporting requirements (21 CFR 803). (3) For each regulation, ask for the FDA required documentation that proves compliance. This has 3 parts; a standard operating procedure (SOP), documentation that the SOP was followed, and evidence that SOP compliance is being evaluated by a quality assurance unit (QAU). Second, regarding information exchange with FDA, key facts in a case often exist in information a company sends to, or receives from FDA. Examples include; product submissions, minutes from meetings and calls, responses to FDA questions and emails. Companies often outsource work to a contract research organization (CRO). Therefore, documentation may be in their possession. #lawsuits #personalinjury
