Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Home Topics

Regulation

Features

The Changing Face of FDA Consent Decrees Image

The Changing Face of FDA Consent Decrees

Joseph Savage & Adam Ziegler

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 Image

Independent Corporate Investigations

Marjorie J. Peerce & Peggy M. Cross

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 Image

Your Best Worker Can Become Your Worst Nightmare

David C. Henderson & Matthew E. Feiner

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 Image

Litigation Readiness

Prashant Dubey

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.

Features

Be Careful What You Wish For Image

Be Careful What You Wish For

Stanley S. Arkin & Barrett N. Prinz

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.

Features

Voluntary Disclosures Under the FCPA Image

Voluntary Disclosures Under the FCPA

Jacqueline C. Wolff & Pamela Sawhney

<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 Image

The McNulty Memorandum

Robert W. Tarun

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? Image

Do Web Sites Need To Be Accessible To the Blind?

Carla J. Rozycki & David K. Haase

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? Image

<b><i>Commentary: </b></i>Just Looking: Should Internet Ignorance Be a Defense to Child Porn Charges?

Howard J. Bashman

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.

Features

Is Your Web Site COPPA Compliant? Image

Is Your Web Site COPPA Compliant?

Alan L. Friel

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.

Need Help?

  1. Prefer an IP authenticated environment? Request a transition or call 800-756-8993.
  2. Need other assistance? email Customer Service or call 1-877-256-2472.

MOST POPULAR STORIES