Allocating Risk Through Contracts. Learn how contracts can be an effective products liability risk management tool when allocating risk between supply chain participants.
Distributor Liability. These materials are for non-manufacturer sellers (NMS) of medical products, such as distributors. Then discuss how an NMS can wind up in litigation and provide some practical tips to reduce products liability risks in everyday transactions.
Document Management. Learn about the products liability risks associated with document creation and management and how to minimize such risks effectively.
Doing Business Globally. Learn about the practices a company can implement to effectively manage the risks associated with doing business globally.
FDA Outlook for 2010. These materials identify emerging regulatory issues and trends in the FDA and discuss possible changes to the 510(k) clearance process. They also discuss new FDA staff in key roles and potential changes in inspection and enforcement activities.
Introduction to the CE Mark. When the CE mark is affixed to a medical device it signifies that the device meets the European Union’s standards for consumer safety. With the gradual elimination of economic boundaries, more and more U.S. manufacturers will need the CE mark on their devices in order to market them in Europe. These resources contain information on the CE mark, including what it is, how to get it, and how to keep it.
Legislative Outlook for 2010. Learn about the major federal legislation that will impact medical technology and life sciences companies in 2010. A 50-minute webinar focuses on the legislation and political trends that may impact your operations and bottom line.
Managing the Risks of Off-Label Promotion. Use these resources to gain valuable insights into some of the problems associated with off-label promotion. Review the applicable laws and regulations and learn how companies can create effective off-label compliance programs.
"No Injury" Class Actions and Emerging Medical Monitoring Claims. Increasingly, “no injury” class action lawsuits are getting attention from the Plaintiffs’ Bar and U.S. courts. Plaintiff classes allege harmful exposures without present physical injuries and seek money to monitor their medical conditions. This is a fundamental shift of the law, veering from compensation for actual injury to compensation for possible exposure.
Off-Label Promotion: Allergan v. USA. Learn about the two (or more) sides of the closely watched debate currently pending before the Court in the case Allergan v. United States of America. Allergan is seeking a ruling that would lift FDA restrictions against promoting drugs for off-label uses. The resources on this page contain information about this important case and how it may impact current off-label promotion practices.
Preemption - Medical Devices. Learn about how federal preemption protects medical device companies from state tort law claims that challenge the safety or effectiveness of premarket approval (PMA) devices.
Pharmacovigilance. Access information about pharmacovigilance and related trends in products liability litigation in the post-Wyeth v. Levine world.
Products Risk and Professional Liability. Many medical technology companies purchase products liability insurance; yet there are risks which may not be covered by these policies. Faced with a myriad of options from insurance carriers, insureds must choose which coverages are needed to manage risk that arise from products. These resources are intended to help the financial manager/insurance buyer understand and make informed decisions about coverage, risk and premium.
Sales Representatives in the OR: Navigating a Liability Minefield. Receive practical insights into ways in which employers can mitigate the risks associated with having sales representatives in the OR.
Social Media & FDA Regulations. Medical technology and life sciences companies are increasingly using social media channels, such as Facebook, Twitter, and LinkedIn, to advertise and educate users about their products. The FDA has repeatedly stated that the same rules that apply to conventional promotional materials also apply to the Internet. The resources on this page contain information on how companies are currently using social media in a manner that is compliant with FDA regulations. They include “best practices” for using social media appropriately and explain the consequences of using social media improperly.
Warnings and Instructions. These materials discuss the products liability risks associated with drug and device warnings and instructions and provide tips on developing warnings and instructions that can minimize those risks. Learn how to identify the type of information that needs to be supplied, to whom, and how best to make it effective.