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Regulation

  • One question that has been raised in pre-emption decisions is the degree of deference to be shown an agency's explicit statement that it intends certain failure-to-warn claims to be pre-empted. For example, in the pharmaceutical arena, the Food and Drug Administration ('FDA') through the Department of Justice ('DOJ') filed amicus briefs in several lawsuits to reiterate its position on pre-emption of state law tort claims. In these briefs, the United States stressed that in the context of warnings, 'more is not always better.' Amicus Brief for the United States, Kallas v. Pfizer, No. 04-00998 (D. Utah Sept. 29, 2005) at 28. The FDA's regulation of prescription drugs ensures each drug's optimal use by requiring inclusion of only scientifically substantiated warnings. Id. Plaintiffs' failure-to-warn claims therefore 'stand as an obstacle' to the FDA's accomplishment of its congressionally mandated purpose of ensuring the public health and are therefore pre-empted. See Id. The FDA has also stated its position on pre-emption in the preamble to its Rulemaking for Labeling requirement, which became effective on June 30, 2006. See 21 C.F.R. '10.85(d)(1) (2006).

    October 30, 2006Vivian M. Quinn and Elizabeth A. Brophy
  • In the legal realm, concern about the security of sensitive data during transport has never been higher. Attorneys from coast to coast have watched the headlines and read countless articles about files and tapes that have been lost or stolen while being moved from Point A to Point B ' during legal discovery activities, perhaps, or to satisfy compliance requirements.
    As a result, law firms and corporate in-house counsel are investigating more dependable methods for securing information during transit, when it is most vulnerable. Many of these experienced denizens of e-data have concluded that encryption provides the greatest protection throughout the chain of custody, and that this locked-door method of data security can be achieved at a relatively reasonable cost.

    October 30, 2006Chuck Bokath
  • Traditionally, job-termination notices took the form of a pink slip of paper that employees found in their mailbox or in the envelope carrying their paycheck.
    Recently, however, tech retailer Radio Shack used e-mails to give more than 400 employees notice of their involuntary separation from the firm. That move probably wasn't the use of technology many in the e-commerce, or the bricks-and-mortar, world envisioned for the business sector.

    October 30, 2006Jonathan Bick
  • As headlines continue to report data security breaches at an alarming rate, discussion often focuses on the need for enhanced technical controls, such as two-factor authentication and encryption, to protect sensitive, personally identifiable information. The role of the company employee, both as the cause of, and the first line of defense against, security breaches is often lost in the analysis. Yet developing law is increasingly requiring administrative or procedural controls, particularly those directed at employees, as a component of a legally compliant security program.

    October 30, 2006Ryan Sulkin
  • The issue of directors' and officers' liability for deepening insolvency has been the source of a significant number of judicial opinions over the past few years with little consensus being reached on the viability of these claims. This may have changed however. Despite the Delaware Bankruptcy Court's recent decision, In re: Scott Acquisition Corp., 2006 WL 1732277 (Bankr. D. Del. 2006), which ruled that directors and officers of insolvent subsidiary companies owe fiduciary duties to both its creditors and the subsidiary itself. The Delaware Chancery Court, Vice Chancellor Leo E. Strine presiding, subsequently and resoundingly waded into the breach of fiduciary duty and zone of insolvency arena with its decision in ,Trenwick America Litigation Trust v. Ernst &Young, L.L.P., et al.

    October 30, 2006Luis Salazar
  • The recent wave of investigations and lawsuits involving the alleged backdating of stock options promises to become one of the most widespread corporate crises in recent years. As these allegations mount, targets of the investigations will look to their insurance companies to help pay their potentially substantial defense costs and any resulting liabilities.
    At the same time, insurance companies will be looking for ways to minimize, or even evade entirely, their coverage obligations. As a result, targets of backdating investigations must move quickly to protect their insurance coverage.

    October 30, 2006Jonathan M. Cohen and John P. Sheahan
  • The composition of the modern corporate board has evolved into a complex and sophisticated governing body that places increasing demands on the lawyers. In the post Enron and Sarbanes-Oxley world, corporate boards continue to be comprised of directors with their own myriad personal and business agendas. These boards, however, have also become more mindful and responsive to watchdog agencies, and have a renewed focus on board independence, financial expertise and diversity. There is, therefore, an increased need for adaptable, experienced, and informed lawyers ' both in house as well as outside a given company ' to counsel the board and its members on these and other controversial issues. The best practices for doing so, including those addressing how to better understand the client board's structure, culture and goals, as well as the board member's personal concerns, is the subject of this piece.

    October 30, 2006Craig C. Martin and Christine A. Leahy
  • As defined by the ADA, a qualifying disability is 'a physical or mental impairment that substantially limits one or more of the major life activities of such individual.' 42 U.S.C. 12102(2)(B), (C). The ADA regulations define disabilities broadly, including a specific reference to 'neurological systems, mental or psychological disorders.' (29 C.F.R ' 1630.2 (h).) Because the ADA only provides such general guidance, litigation continues to arise as parties try to refine the concepts presented in the Act, such as whether a mental disorder is a qualifying impairment, whether an employee with a qualifying mental illness can perform essential job functions, and how the limitation of a major life activity caused by a qualifying mental illness can be reasonably accommodated in the workplace.

    October 30, 2006Jonathan O. Hafen
  • Do divorce lawyers have an obligation to disclose client confidences when it is in the best interests of the client's child to do so? The short answer of the rules of professional responsibility is 'no' because a 'yes' answer is deemed to be fundamentally inconsistent with the premises of the adversary system in which the divorce lawyer functions. The longer answer is that the rules encourage ' but do not require ' a divorce lawyer to counsel the client to authorize the disclosure because it is in the best interests of both parent and child.

    October 30, 2006Andrew Schepard
  • The Family Educational Rights and Privacy Act of 1974 (20 USC ' 1232g), more commonly referred to as FERPA, is a federal law that protects the privacy of student education records. FERPA applies to all schools that receive public funding. FERPA's terms contradict the commonly held belief that a non-custodial parent's right to a child's education record is defined only by the text of the stipulation of settlement or court order.

    October 30, 2006Robin D. Carton