Developing Warnings & Instructions to Reduce Products Liability Risks and Communicate Effectively
Overview:
While life sciences companies must comply with FDA requirements related to warnings and instructions, compliance does not provide them with an absolute defense in products liability cases. The FDA may find a particular warning or instruction to be adequate, but the standards for what constitutes an adequate warning or instruction under products liability law are different from the FDA’s requirements, meaning that FDA compliance does not prevent products liability exposures from arising from warnings and instructions. Life sciences have considerable flexibility when it comes to the development of warnings and instructions and should ensure that they are designed to minimize products liability risks.
How You Will Benefit:
This course provides participants with key information about products liability law as it relates to warnings and instructions. It covers the fundamentals of failure to warn claims, describes the characteristics of adequate warnings and instructions, and suggests “best practices” that manufacturers can use to reduce products liability risks and improve the information they provide to health care professionals and patients.
Course Outline:
The following will be covered in this course:
- Explains common law and state products liability law, including a manufacturer’s duty to warn and the importance of an “adequate” warning;
- Describes the relationship between regulatory requirements, industry standards, and products liability;
- Discusses case studies about warnings and instructions that have been deemed inadequate and the related products liability consequences;
- Identifies the common mistakes that manufacturers make when developing warnings and instructions;
- Describes how a label’s format and appearance can impact its products liability risk;
- Emphasizes the need to integrate the development of warnings and instructions into the product design process;
- Teaches participants to recognize the characteristics of effective and “adequate” warnings and instructions; and
- Provides “best practices” for writing effective warnings and instructions that may reduce products liability risks and enhance communication with health care professionals and patients.
Who Should Attend:
Anyone who is involved in the process of developing warnings and instructions. Additionally, this course should be attended by employees who have direct contact with healthcare professionals and patients, such as sales representatives and customer service personnel.