Features
Case Briefing
Recent rulings of importance to your practice.
Features
Risk Assessment and Post-Market Programs
How do the medical device industry and the FDA prevent risks to the end user once the product is marketed? There is no simple answer to this question. Post-market vigilance in terms of risk assessment involves complex issues. These issues involve a cost/benefit analysis in terms of a "best approach" to post-market co-vigilence.
Features
FDA Cannot Force an Over-the-Counter Drug Switch
Does the Food and Drug Administration have authority to force manufacturers of prescription drug products to switch those products to over-the-counter (OTC) distribution against their will? The FDA is currently grappling with this issue, a dispute that has generated substantial controversy, including statements by FDA officials and coverage in leading newspapers.
Pennsylvania Remains a <i>Frye</i> State
Chief Justice Ralph J. Cappy of Pennsylvania's Supreme Court issued an opinion on Dec. 31, 2003, declaring that the State of Pennsylvania would remain a "<i>Frye</i> state" and would not follow suit with much of the rest of the nation in using the <i>Daubert</i> test to qualify expert witnesses.
The Bankruptcy Hotline
Recent rulings of importance to you and your practice.
Features
What Should You Know About the Rules of Evidence?
Bankruptcy lawyers who rarely visit a courtroom may think they do not need to worry about the rules of evidence. Yet evidentiary rules can provide critical protections. In a typical case or negotiation, lawyers create and circulate tremendous amounts of information -- much of which would be potentially damaging if obtained by other parties. To protect this information, bankruptcy lawyers need to be familiar with the rules of evidence and how courts have interpreted these rules.
Features
Official Committee Members: Fiduciary Duty Liability
Members of official creditors' committees in Chapter 11 cases owe a fiduciary duty to the entire body of unsecured creditors. <i>See Woods v. City National Bank</i>, 312 U.S. 262, 268-69 (1941). As fiduciaries, committee members should have undivided loyalty to those they serve, free of any conflict of interest. <i>Id</i>. The imposition of such a broad duty to unsecured creditors generally might be otherwise unremarkable, except that committee members themselves obviously have significant selfish interests in the outcome of the bankruptcy case.
Professional Fees: How to Get a Bankruptcy Judge's Attention
How does a bankruptcy professional get the court's attention on fees? Chief Bankruptcy Judge Mary F. Walrath of the District of Delaware answered the question with a detailed 33-page opinion on Dec. 23, 2003. <i>In re Fleming Companies, Inc., et al</i>, 2003 Bankr. LEXIS 1727 (Bankr. D. Del. 2003). Disposing of an objection by the United States Trustee to interim professional fee applications, Judge Walrath said she would "reduce the fees requested by the Debtors' professionals." <i>Id.</i> at 5. Not exactly the kind of attention any lawyer wants.
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
- 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 ›
- Legislative Protections Against AI Voice ScamsA wide range of tools have been developed to perform vocal cloning, leading to vocal deepfakes becoming a common source of scams and misinformation. And these issues have only been exacerbated by a lack of appropriate laws and regulations to rein in the use of AI and protect an individual's right to their voice.Read More ›
- 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 ›
- Join Us For a Twitter Chat: Do We Need Offices Anymore?When we think about how the COVID-19 pandemic has changed the legal industry, one (frankly huge) question comes to mind: Do we really need offices anymore? As many are still working from home, meeting with clients over Zoom and some even conducting jury trials online, life of commuting to and from work seems farther away than February.Read More ›
