Category Archives: Treatise

6 Temporary Detention Tips for Defense Attorneys

John L. Weinberg’s Federal Bail and Detention Handbook 2016 offers insightful advice on temporary detention. Below, find Judge Weinberg’s six temporary detention tips for Defense Attorneys:

Prior to the initial appearance, gather as much information as possible as to whether the case is appropriate for entry of an order of temporary detention. Be prepared to argue these issues at the initial appearance. Determine also, if possible, whether the other court or INS intends to place a detainer or has already done so.
If the U.S. Attorney moves for temporary detention at the initial appearance, be prepared to present any available challenge to its eligibility, under either half of Sec. 3142(d).
Be prepared to propose and defend a specific duration of temporary detention. Whatever duration is set, ask the court to schedule a further hearing on release or detention for the day the temporary detention order expires.
Decide whether you will move for pretrial detention, which extends beyond any period of temporary detention. If so, make this motion as well at the initial appearance. The court should set the hearing for the last day of the period of temporary detention.
If at the initial appearance the court has ordered temporary detention, contact the other court or agency promptly thereafter. Attempt to persuade the other authority to decline to seek custody of defendant.
If a detainer is lodged or if the other authority declines to proceed before the order of temporary detention expires, contact the court and attempt to reschedule the bail status hearing for an earlier date.

TO LEARN MORE ABOUT TEMPORARY DETENTION TIPS, INCLUDING ADVICE FOR U.S. ATTORNEYS, READ:

Federal Bail and Detention Handbook 2016 John L. Weinberg (U.S. Magistrate Judge for the Western District of Washington at Seattle)

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3 Elements of an FDA Recall Strategy

James P. Ellison and Anne K. Walsh’s FDA Deskbook: A Compliance and Enforcement Guide provides an in-depth discussion on recalls.

A firm conducting a recall must develop a recall strategy taking into account the results of the Health Hazard Evaluation (HHE), ease in identifying the product, the degree to which the product’s deficiency is obvious to the consumer or user, the degree to which the product remains unused in the marketplace, and the continued availability of essential products. FDA will review and approve the recall strategy of a recalling firm. The elements of a recall strategy are:

Depth of Recall The depth of recall pertains to the level in the distribution chain to which the recall will be extended. This will depend on the product’s degree of hazard and extent of its distribution. For example, the recall could extend all the way to the consumer or user level, it could stop at the retail level, or it may not need to go beyond the wholesale level.
Public Warning A public warning is intended to alert the public that “a product being recalled presents a serious hazard to health.” It is only used in urgent situations for which other means of preventing use of the product appear inadequate. FDA will usually issue the warning in consultation with the recalling firm. If the firm issues its own warning, it should submit the warning to FDA for review and comment prior to distribution, along with a plan for distribution. The recall strategy should indicate whether a public warning is needed and how it will be issued, for example, via general or specialized news media.
Effectiveness Checks Effectiveness checks are required to confirm that all consignees at the specified recall depth received the notification. Consignees may be contacted by whatever means deemed appropriate by the recalling firm, including by letter, telephone calls, or a combination. It is recommended that a firm conduct at least the initial effectiveness check in writing, and may then follow up via telephone if no response is received. When a phone call is made, the firm should document the call and that documentation should be retained in the recall record. The recall strategy will specify the methods to be used and the level of effectiveness checks that will be conducted. Depending on the product involved and the health hazard presented by the product, a firm may be required to contact 100% of consignees, or may not be required to conduct an effectiveness check at all.

TO LEARN MORE ABOUT THE FDA, READ:

FDA Deskbook: A Compliance and Enforcement Guide Edited by James P. Ellison and Anne K. Walsh (Hyman, Phelps & McNamara, P.C.)

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What’s New on Discover PLUS for May

We add content to PLI Discover PLUS every month to ensure our subscribers have access to the most up-to-date and relevant secondary source legal documents. Renowned legal experts regularly updated our acclaimed Treatises, Course Handbooks, Answer Books, Transcripts and Forms to reflect recent changes and developments in the law.

Click here to see what we added in May.

New Treatise! FDA Deskbook: A Compliance and Enforcement Guide

FDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under The Federal Food, Drug, and Cosmetic Act (FDC Act) and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government. This new title fully explains the legal framework created by the FDC Act and subsequent statutes, regulations, guidance and policies governing the food and drug industry.

Written by attorneys at Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug law firm in the U.S., the FDA Deskbook incorporates more than a century of cumulative experience from positions at FDA, the U.S. Department of Justice, the Drug Enforcement Administration, U.S. Attorney’s Offices, and regulated industry. The result is this essential guidebook, which aims to assist industry stakeholders by providing a wide-ranging review of compliance and enforcement under the FDC Act and related laws.

The FDA Deskbook first details the ins-and-outs of FDA’s administrative actions (such as warning letters, import alerts, and recalls) and civil and criminal enforcement authorities. The FDA Deskbook then walks the reader through individual chapters highlighting specific issues affecting the cross-section of FDA regulation:

drugs, including OTC, prescription, and compounded drugs, and controlled substances
medical devices, including in vitro diagnostic devices
food and dietary supplements
tobacco
animal products
cosmetics

Importantly, the FDA Deskbook contains chapters focused on today’s hot button issues, such as advertising and promotion, fraud and abuse, and good manufacturing practices. The FDA Deskbook proposes best practice tips, including how to deal with FDA inspections, alternatives to conducting internal investigations, and potential defense strategies for use in enforcement proceedings.

The FDA Deskbook provides a thorough discussion of the current landscape necessary for FDA-regulated entities to achieve compliance and avoid enforcement action.

This essential new title is available on PLI Discover PLUS, our online research database. If you’d like to order a print copy, please email the PLI Library Help Desk or call 877-900-5291.

Law Day Sale!

Happy Law Day! To celebrate, we’re offering 40% off all PLI Answer Books and Treatises until midnight tonight:

Last Day – National Library Week Book Sale!

2016 National Library Week II

In celebration of National Library Week, Practising Law Institute is offering a 20% discount on all Treatises and Answer Books from April 10 – 16. Today is the last day of our sale!

Prefer to do your research digitally? We encourage you to access our publications online through a subscription to PLI’s research database, Discover PLUS. Discover PLUS gives you access to our Course Handbooks, Treatises and Answer Books, in addition to over 3,000 downloadable forms and close to 1,000 program transcripts.

Trial Handbook Spring 2016 Edition Now Available

The S Trial Handbook Spring 2016 pring 2016 edition of The Trial Handbook is now available in print and on PLI Discover PLUS, our online research database!

Trial Handbook is the one-stop resource you can trust in the planning, trial, and post-trial stages of litigation. Designed for quick reference in the courtroom, Trial Handbook is keyed to the Federal Rules of Evidence and focuses on the presentation of proof and the evidentiary problems faced by counsel.

Packed with practical checklists, charts, outlines, sample jury selection questions, Trial Handbook gives you the knowledge and tools to:

Develop solid trial briefs and strong case plans
Prepare lay and expert witnesses and organize your exhibits more effectively
Master voir dire to maximize your chances of getting the most sympathetic jurors
Make a clear record at trial to aid jurors’ understanding of your case
Build a rapport and your credibility with the jury throughout the trial
Use opening statements to put your cases, clients, and proof in the most favorable light
Give summations that blend evidence and issues to paint a thoroughly persuasive picture
Exploit discovery materials at trial to get an additional edge
Lay the proper foundation for various forms of evidence
Capitalize on the powerful probative impact of visual aids at trial
Apply proven direct examination and cross-examination techniques
Use pretrial, trial, and post-trial motions to gain strategic advantages
Draft clear, legally sound jury instructions that subtly sway judges

At the heart of Trial Handbook is its unique Evidence Guide, now also included as a laminated fold-out, which clearly explains the meaning, purpose, operation, and history of every rule, including how each rule applies to other cases and how leading cases construe a particular rule.

Volume 2, the Case Authority, includes thousands of case summaries of decisions under the rules, arming you with the latest evidentiary resources to help you prevail at trial.

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Federal Bail and Detention Handbook 2016 Now Available

The 2016 Federal Bail and Detention Handbook, written by the Honorable John L. Weinberg, provides judges and lawyers alike with quick, on-point answers to all aspects of federal bail and detention law. The Handbook provides legal professionals with a comprehensive guide to the Bail Reform Act of 1984, including relevant statutory language, legislative history and appellate case law. It analyzes each step of the process, including:

The Handbook’s Table of Cases lists every federal appellate decision of significant precedential value that interprets or applies the Act.

Designed as a practical tool to be used both in court and the office, 2016 Federal Bail and Detention Handbook includes “Practice Pointers,” designed by Judge Weinberg to provide defense counsel and Assistant U.S. Attorneys with strategic suggestions for dealing with the Act. In addition to the sample orders and motions included in the Handbook, the 2016 edition includes, in Appendix III, a comprehensive collection of the official, nationally recommended forms relating to release and detention.

The Treatise is available for purchase here and is also accessible online on our digital research platform, PLI Discover PLUS.

Interested in our other Litigation resources? Check out our Litigation Research Center below!

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Special Report: “The FAST Act and Other Recent Developments Affecting the IPO Market”

On December 4, 2015, President Obama signed into law the Fixing America’s Surface Transportation Act, known as the FAST Act. Although aimed primarily at authorizing spending on highway and transit projects, the FAST Act includes several amendments to the Jumpstart Our Business Startups Act (JOBS Act) and other securities law provisions. The aspects of the FAST Act applicable to IPOs are already in effect, while other provisions are subject to future SEC rulemaking. The changes made by the FAST Act, together with other recent developments, will help shape the IPO landscape in the coming year and beyond.

To help practitioners cope with these changes, PLI just published a special free report exploring the FAST Act’s impact on the IPO market. Written by David A. Westenberg (WilmerHale), author of PLI’s Initial Public Offerings: A Practical Guide to Going Public, the report provides a summary of developments stemming from the FAST Act, as well as of their implications. Download the report here or you can find it in the table of contents for Initial Public Offerings: A Practical Guide to Going Public.

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