Features
The Changing Face of FDA Consent Decrees
Historically, when a health care company had a compliance failure, counsel could help it remain in business by negotiating with the relevant agency. If the problem involved sales, marketing or pricing, the company could seek a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) at Health and Human Services (HHS). If the problems related to manufacturing, counsel could obtain a consent decree of permanent injunction ('consent decree') with the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act (FDCA). Consent decrees and CIAs each had their particular burdens and benefits, which health care practitioners had learned to navigate. Now this tidy distinction has become blurred as the FDA has borrowed features from HHS's CIAs.
Features
Independent Corporate Investigations
In this age of regulatory and prosecutorial focus on corporate compliance, companies increasingly are relying on special outside counsel to conduct internal investigations into potential wrongdoing. Sometimes, these investigations are prophylactic: A company may want to understand the consequences of its current hiring practices so it can develop standard operating procedures to better ensure compliance with anti-discrimination laws. Because this sort of proactive, self-reflective investigation generally proceeds without outside scrutiny, counsel has the time and space to conduct a deliberate investigation.
Features
Your Best Worker Can Become Your Worst Nightmare
Although difficult to imagine, your best worker may hold the key to your company's worst security nightmare. Technologically armed employees who routinely use BlackBerry devices, personal digital assistants, laptops, and tiny flash drives to transport critical information to and from the office can wreak havoc on a corporation '' with no intention to do so.
Features
Litigation Readiness
With the amendments to the Federal Rules of Civil Procedure (FRCP), precedent-setting adverse sanctions against some of the largest corporations and growing regulatory requirements, the need to become 'litigation ready' has been like a large snowball, gaining mass and momentum. The indisputable need to become litigation ready has arrived, and the snowball continues to get bigger and faster as it heads down the mountain. With the FRCP amendments, Dec. 1 has come and gone and guess what? Nothing has exploded.
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Be Careful What You Wish For
In the wake of the demise of Arthur Andersen following the partnerships' indictment by the federal government, prosecutors are increasingly pressuring corporations to enter into deferred-prosecution agreements (DPAs) to avoid ' at least temporarily ' full-blown criminal prosecutions. While these agreements may seem to offer an attractive option to embattled companies faced with the prospect of a lengthy and potentially devastating criminal prosecution, the freedom with which the individual prosecutors operate when crafting the agreements should cause concern.
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Voluntary Disclosures Under the FCPA
<i>' ' [A]lthough nothing is off the table when you voluntarily disclose, I can tell you in unequivocal terms that you will get a real benefit ' '</i> Despite these heartening words by Assistant U.S. Attorney General Alice S. Fisher at a recent conference on the Foreign Corrupt Practices Act (FCPA), an attorney representing a corporation cannot recommend voluntary disclosure of potentially criminal FCPA activities without weighing the promise of a 'real benefit' against the very real risks.
Features
The McNulty Memorandum
The Department of Justice (DOJ), in the wake of increasing criticism of its policies on waiver of privileges by corporations and their advancement of legal fees to employees under investigation, issued a 21-page memorandum on Dec. 12, 2006, revising the 'Principles of Federal Prosecution of Business Corporations,' alias the Thompson Memorandum. The revised policy, embodied in a memorandum by Deputy Attorney General Paul D. McNulty, comes close on the heels of two influential attacks on the Thompson Memorandum: a bill sponsored by Sen. Arlen Specter (R-PA) that would prohibit prosecutors from pressing companies to waive privileges or cut off legal fees, and an opinion by Manhattan U. S. District Judge Lewis A. Kaplan, holding that prosecutors had violated the constitutional rights of former KPMG partners when they pressured KPMG to stop paying the ex-partners' lawyers.
Features
Do Web Sites Need To Be Accessible To the Blind?
An advocacy group has sued Target Corp., claiming that Target's Web site is incompatible with software used by the blind and that such incompatibility is a violation of the Americans with Disabilities Act (ADA).
Features
<b><i>Commentary: </b></i>Just Looking: Should Internet Ignorance Be a Defense to Child Porn Charges?
Two appellate courts recently ruled that an individual who intentionally visited Web sites to view child pornography, but who did not intentionally save those images to his computer's hard drive, could not be convicted or punished for possessing images that were automatically saved due to the Web browser's cache functions. These rulings strike me as badly mistaken, for reasons that I shall explain further below.
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Is Your Web Site COPPA Compliant?
In 1998, Congress passed the Children's Online Privacy Protection Act (COPPA), broadly expanding the Federal Trade Commission's (FTC) enforcement powers in the Internet arena. Since then, states and the FTC have become more active in regulating the collection, use and security of consumer's personal information generally. However, the protection of children's personal information remains a top FTC enforcement goal, and the commission has become more aggressive in enforcement of COPPA each year. Companies that fail to proactively act to ensure COPPA compliance do so at the risk of seven-figure penalties. <br>This article provides Web site operators with suggestions on how to comply with the spirit of COPPA when legal obligations are not crystal clear, as in the case when the operator of the Web site in question believes that it can make a good faith effort to be a 'general audience' Web site, but has reason to believe that the site may attract visitors under the age of 13 and is unsure how the FTC will view and treat the site.
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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 ›
- Bankruptcy Sales: Finding a Diamond In the RoughThere is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.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 ›
- Supreme Court Asked to Assess Per Se Rule Tension in Criminal AntitrustIn recent years, practitioners have observed a tension between criminal enforcement of the broadly written terms of the Sherman Antitrust Act of 1890 and the modern Supreme Court's notions of statutory interpretation and due process in the criminal law context. A certiorari petition filed in late August in Sanchez et al. v. United States, asks the Supreme Court to address this tension, as embodied in the judge-made per se rule.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 ›
