PRODUCT LABELING EXPERT WITNESSES

Expert Witness: E-008723
This Nutrition industry professional has an advanced degree in nutrition, and several years of experience involving the technical aspects of regulatory affairs, scientific affairs, product labeling, and research & development. His specialties: 21 CFR 101 (Food Labeling), 21 CFR 111 (cGMPs for dietary supplements), FTC advertising guidelines, regulatory compliance review, product substantiation, ingredient research and product development. In his current role as Manager ...
Expert Witness: E-099215
This expert has experience in Medical devices since 1992. Design experience since 1986. Areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. Granted 28 patents (others pending), 7 awards, designs published by Life Magazine, was recognized as one of 100 ...
Expert Witness: E-072055
This industry veteran has been in the consumer products market for 40+ years, including 35 years spent at Amway Corporation. He has been active throughout his career as a scientist and group leader in the development of consumer products, particularly those involving chemical formulations (detergents, cosmetics, cleaners, and others). Since the 1980s, the expert has been active in formal programs that contribute to scientific public policy. He has provided input to ...
Expert Witness: E-007728
This expert has been working in regulatory affairs for nearly 25 years. As a Regulatory Affairs Associate with Bayer Healthcare Pharmaceuticals, he gained significant experience in all facets of drug life cycle, from coordinating, evaluating, and filing submissions for new and marketed products, to responding to Health Canada requests and negotiating with Health Canada scientific reviewers, to preparing and following clinical trial applications. He wrote and revised ...

PRODUCT LABELING EXPERT WITNESS CASE STUDIES

Drug Manufacturer Allegedly Fails To Meet FDA Labeling Standards PRODUCT LABELING Expert Case

This case involves an otherwise healthy 39-year-old woman with a history of trouble conceiving who was told by her physician that taking Vitamin E supplements could increase her chance of conception. The woman purchased a bottle of over-the-counter Vitamin …

Warning Label Experts Discuss Inadequate Labeling on Small Electronics PRODUCT LABELING Expert Case

This case involves a mother in Mississippi who bought a package of small, battery powered toys with multicolored LED illumination. The mother distributed the toys to her own children as well as several of their friends during a birthday party at the defen …

Drug Manufacturer Fails to Warn Patients of Medication Risks PRODUCT LABELING Expert Case

Drug Manufacturer Fails to Warn Patients of Medication Risks

…  case takes place in Florida and involves the labeling protocols for a name-brand prescription drug and its generic …  the drug had correctly warned patients by instituting the labeling change – however, generic versions of the drug did not change their …

Inadequate Warning on Water Pump Leads to Injuries PRODUCT LABELING Expert Case

Inadequate Warning on Water Pump Leads to Injuries

This case takes place in New York and involves a farmer who was injured while testing a portable irrigation pump. During pressure testing, the pipe was attached to the pumping apparatus and was filled to a few hundred pounds of pressure. At some point duri …

Robotic Surgery System Causes Thermal Burns PRODUCT LABELING Expert Case

Robotic Surgery System Causes Thermal Burns

This case takes place in Colorado and involves patient who underwent a hysterectomy using a Da Vinci Surgical System. The patient suffered thermal rectal burn/perforation that was unrecognized during the procedure. She subsequently developed a range of is …

Laundry Detergent Sold With Misleading Warnings PRODUCT LABELING Expert Case

Laundry Detergent Sold With Misleading Warnings

This case takes place in Illinois and involves single use detergent pods. The pods in question are brightly colored and packaged in a way that resembles an edible item. Additionally, The liquid in the pods is under so much pressure that when bitten it is  …

Company Forced to Recall Products by FTC PRODUCT LABELING Expert Case

Company Forced to Recall Products by FTC

…  a pharmaceutical company that was ordered to remove products from retail outlets in a nationwide recall. The plaintiff filed a …  that the defendants had made revised statements about four products that are not substantiated by competent or reliable scientific …

Human factors expert witness advises on fatal burns caused by mislabeled chemicals PRODUCT LABELING Expert Case

…  witnesses with specialties in human factors, consumer product safety and forensic chemistry advise on a case involving a worker who …  the chemical supplier committed negligence and strict product liability when it delivered chemical containers that were mislabeled or …