Features
A Regulatory Lawyer's Perspective: The FDA's Guidances on Risk Assessment, Minimization and Management
In the pharmaceutical industry, due to all types of business pressures and constraints, it is not atypical for a company to behave reactively and in triage-mode, rather than considering proactive steps that it can take in the compliance arena. In 2005, the Food and Drug Administration ("FDA") issued three final guidance documents to help focus the industry and encourage companies to consider more thoughtfully and thoroughly the issues of quality risk assessment, minimization, and management collectively.
Increasing Equipment Reliability
While we used to copy millions of pages a month and send out hundreds of overnight mail packages a day, current copying rates have dropped to a few hundred thousand pages, replaced by thousands of e-mails per day and "scan to PDF and print" jobs totaling millions of pages. With these advances in technology have come heightened client expectations to complete work in minutes or hours, rather than days. This means our equipment has to be very reliable and easy to use, allowing the attorneys to spend their available time focused on legal work, not on mechanical problems with scanners, copiers and printers.
Features
Protecting E-mail For Complete Client Privacy
Attorney-client privilege, liability for breach of confidentiality obligations and damage to a firm's reputation were all reasons originally cited for stopping the use of e-mail at law firms before it even started. Convenience and responsiveness to clients became justification enough to ignore the basic issue that e-mail was inherently insecure. The standard form disclaimer that we now see at the end of every lawyer's e-mail became the solution to protecting the confidential nature of attorney-client communications. Is it sufficient today?
Strategies Needed To Support Compliance Policy Initiatives
Proactive Compliance. Risk Management. Loss Prevention. Regardless of what you call it, all firms have the need to assure that client information is handled properly at all stages, to mitigate litigation and penalty risks, and to protect client and firm reputation.
<b>Practice Tip:</b> Processing Evidence: The Technical Challenges of Lotus Notes
Lotus Notes, the desktop client for the Lotus Domino collaboration product suite, is one of the more widely used messaging platforms in large corporations. The unique aspect of Lotus Notes is that it's an application environment, as well an e-mail exchange system. It provides a platform from which to build a wide range of business applications where messaging and collaboration are the necessary foundation.
Features
Lawyers Recruiting Mock Juries on the Net
After months of preparation, the lawyers at Sanders, Simpson & Fletcher had their case almost ready for trial. The Springfield, MO, plaintiffs' firm of 11 lawyers had worked hard to fine-tune the civil case. Their client had the potential of being awarded significant damages. But the allegation -- sexual misconduct against a church pastor -- was tricky. Would the facts of the case resonate well with jurors?
New Jersey's Highest Court Admits Expert Testimony
The New Jersey Supreme Court, in <i>Creanga v. Jardal</i>, 185 N.J. 345 (2005), recently held that a treating physician's expert testimony on proximate cause is admissible if based on a reasonably conducted differential diagnosis that rules out plausible alternative causes of a plaintiff's injuries. However, a treating physician's expert testimony will be struck as a net opinion when the physician's differential diagnosis is based on subjective beliefs instead of the patient's medical history and diagnostic testing.
Features
Special Medical Malpractice Courts
In the midst of the medical liability crisis and a nationwide movement toward tort reform, including caps on non-economic damages, a new player has appeared on the scene. The "Fair and Reliable Medical Justice Act," S. 1337, was introduced to the U.S. Senate in July 2005 in a bipartisan effort led by Sens. Michael Enzi (R-WY) and Max Baucus (D-MT). The stated purposes of the Act are: "1) to restore fairness and reliability to the medical justice system by fostering alternatives to current medical tort litigation that promote early disclosure of health care errors and provide prompt, fair, and reasonable compensation to patients who are injured by health care errors; 2) to promote patient safety through early disclosure of health care errors; and 3) to support and assist States in developing such alternatives."
Need Help?
- Prefer an IP authenticated environment? Request a transition or call 800-756-8993.
- Need other assistance? email Customer Service or call 1-877-256-2472.
MOST POPULAR STORIES
- The DOJ's New Parameters for Evaluating Corporate Compliance ProgramsThe parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.Read More ›
- Strategy vs. Tactics: Two Sides of a Difficult CoinWith each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.Read More ›
- Use of Deferred Prosecution Agreements In White Collar InvestigationsThis article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.Read More ›
- The DOJ's Corporate Enforcement Policy: One Year LaterThe DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.Read More ›
- When It Comes to Trademark Searches, AI Misses the MarkArtificial intelligence tools powered by large language models have become valuable resources in the trademark process. Despite incredible progress in natural-language reasoning, AI tools still face fundamental limitations when it comes to performing even basic trademark searches. Here are five important reasons why.Read More ›
