Off Label Use Expert Witnesses

Dermatology, Disability Evaluation - Occupational, Work Exposure, Pediatric dermatology, Misdiagnosis, Biologic agent, Immunosuppression, Adverse Reaction, Delayed diagnosis, Melanoma, Skin cancer, Mohs surgery, IMO IME, Opportunistic infection, Sepsis, Off Label Use, FDA boxed warning, DOD Military, Veteran Administration

Broad Experience: U.S. Army, Veteran Administration, Family Medicine, Occupational Medicine, Disability Evaluation, Independent Medical Opinions (IMO), Independent Medical Examinations (IME), Medical Review, Veterinary Medicine, and Hospital Medicine. Licensed in MI, FL, WV, NY, CA, GA, PA, OH, VA, IL, NC, TX, ID, MO, AL, and MN. Active Error Omission Insured. Efficient, accurate, referenced, and bulletproof IMEs and IMOs. Published author of three articles in peer-reviewed journals. Special interest in cases involving injuries, hospitalization, infection, and death due to misuse of dermatologic medications outside of labeled indications, and without regard to FDA boxed warnings. Also interested in injuries and misdiagnosis resulting from a lack of supervision and training of physician extenders in both civilian, DOD, and VA facilities. Over 30 years of experience in military medicine, family medicine, general medicine, occupational medicine, Mohs surgery, and dermatology. Availabl...

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J: Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products. Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World. Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?” Provide leadership in support of label development for new applications, supplemental appl...