Category Archives: Health Care

PLI Current: COVID-19 Special Issue

PLI Press published a special issue of PLI Current to address the developing effects of the COVID-19 outbreak on the legal community. Covering a variety of legal issues related to COVID-19, this special issue contains a mix of original reportage, program materials and transcripts from recent PLI One Hour Briefings. Below is a list of contents along with links to individual articles.

*All articles and online programs related to the global coronavirus crisis are free to access with your PLI login. For upcoming programs, visit pli.edu/coronavirus.

COVID-19: Reducing the Spread of Both Illness and Social Panic
Coronavirus: What Lawyers Need to Know: Transcript of the PLI One Hour Briefing, conducted March 10, 2020
Coronavirus: What Lawyers Need to Know (program materials)
Coronavirus: Insurance Coverage for Event Cancellation, Travel and Supply Chain Losses: Transcript of the PLI One Hour Briefing, conducted March 17, 2020
Coronavirus: Insurance Coverage for Event Cancellation, Travel and Supply Chain Losses (program materials)
Investment Adviser Regulatory Update: Considerations Regarding the Coronavirus and Getting Ready for the 2020 ADV Update Season: Transcript of the PLI One Hour Briefing, conducted March 18, 2020
Investment Adviser Regulatory Update: Considerations Regarding the Coronavirus and Getting Ready for the 2020 ADV Update Season (program materials)
COVID-19 and the Cyber-Risks of Working from Home: Meeting the Challenges: Transcript of the PLI One Hour Briefing, conducted March 25, 2020
COVID-19 and the Cyber-Risks of Working from Home: Meeting the Challenges (program materials)
COVID-19 Challenges for First Quarter 2020 Form 10-Q and Annual Meetings: Transcript of the PLI One Hour Briefing, conducted March 26, 2020
COVID-19 Challenges for First Quarter 2020 Form 10-Q and Annual Meetings (program materials)
How Employers Can Manage the Coronavirus/COVID-19 Pandemic: Your Workplace Questions Asked—and Answered!: Transcript of the PLI One Hour Briefing, conducted March 26, 2020
How Employers Can Manage the Coronavirus/COVID-19 Pandemic: Your Workplace Questions Asked—and Answered! (program materials)
Coronavirus Considerations: SEC Disclosure, Labor & Employment, Insurance, Litigation, Breach of Contract and Force Majeure Issues: Transcript of the PLI One Hour Briefing, conducted March 27, 2020
Coronavirus Considerations: SEC Disclosure, Labor & Employment, Insurance, Litigation, Breach of Contract and Force Majeure Issues (program materials)

New Edition! Health Care M&A Answer Book

M&A activity in the health care industry is at its highest level since the 1980s. Health Care Mergers and Acquisitions Answer Book (2019 Edition) provides the reader with a roadmap to this booming sector, offering practical advice on how to address the various industry-specific issues arising in health care acquisitions. Its broad coverage, presented in Q&A format, is organized into four parts — structuring transactions, due diligence, documentation, and special topics.

Health Care Mergers and Acquisitions Answer Book analyzes recent health care transactions and provides practice tips on how to avoid the various pitfalls that may be encountered while working on health care transactions. It covers dealmaking involving pharmaceutical and biotech companies, hospitals, health insurers and private equity and financial services firms investing in the health care sector.

In addition to transactions involving outright acquisitions of health care companies, Health Care Mergers and Acquisitions Answer Book reviews alternative structures used in health care M&A transactions, such as joint ventures, strategic alliances, product and portfolio acquisitions, option transactions, and licensing and collaboration agreements.

This essential answer book is available on PLI PLUS. If you would like to purchase a print copy, please email libraryrelations@pli.edu.

New Edition! Legal Guide to the Business of Marijuana

Legal Guide to the Business of Marijuana is a unique resource for lawyers who represent clients in what has been called the fastest growing industry in the United States. Many states now allow medical and/or recreational use of marijuana, but it remains illegal under the federal Controlled Substances Act. As a result, marijuana enterprises must operate in a legal and regulatory environment of uncertainty and rapid change, and lawyers representing these enterprises must tread carefully when advising clients.

Written by James T. O’Reilly, a lawyer and public health specialist, Legal Guide to the Business of Marijuana offers critical guidance to help lawyers effectively represent their clients while steering clear of seen and as yet unseen perils implicit in the continued federal-state conflict. Highlights of the 2019 Edition include:

Discussion and summary of the new laws in Michigan, Missouri, Oklahoma and Utah, the latest states to enact some form of legalization.
Coverage of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), which legalized production of hemp nationwide while also retaining the regulatory power of the FDA over CBD products derived from hemp.
Updated state-by-state Appendix of cannabis-related statutes, regulation, and court cases

This essential treatise is available on PLI PLUS. If you would like to order a print copy, please contact libraryrelations@pli.edu.

New Edition! Medical Devices Law and Regulation Answer Book (2019 Edition)

PLI recently published the 2018 edition of Medical Devices Law and Regulation Answer Book, in which more than thirty contributors from various law and consulting firms share their expertise regarding the wide range of topics encountered in this heavily regulated field.

This book provides in-depth coverage of individual FDA programs that govern everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations and more. Presented in a question-and-answer format, this guide also discusses related topics that have a marked impact on the medical devices industry, such as intellectual property, product liability, and reimbursement.

Medical Devices Law and Regulation Answer Book is designed to distill the essential elements of this complex regulatory environment and provide a practical guide to the complexities of FDA regulation of medical devices. It is a practical, in-depth reference for all lawyers, consultants, and companies operating in the medical devices sector, as well as all companies contemplating entertering it .

This updated answer book is available on PLI PLUS, our research database. If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.

New Edition! Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition)

PLI recently published the 2018 edition of Pharmaceutical Compliance and Enforcement Answer Book, which provides a comprehensive overview of the complex regulatory issues faced by the different participants in the pharmaceutical industry.

This resource gives clear, expert answers to questions on topics such as:

Filled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.

This new answer book is available on PLI PLUS, our research database. If you’d like to order a print copy, please email libraryrelations@pli.edu or call 877.900.5291.