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Employers go to great lengths and expense to reduce their potential exposure to employment-related claims. Most employers implement policies to address the myriad and growing federal, state, and local employment laws; regularly conduct employee EEO training; hire qualified human resources professionals and in-house attorneys with expertise in employment law; and regularly seek advice and assistance from outside counsel concerning these prophylactic measures. The purpose of this article is to apprise readers of a fast, simple, and inexpensive way to reduce their exposure to certain types of employment-related claims through the inclusion of an express waiver ('Waiver') in an employment application or other document signed by applicants or employees. The Waiver contractually reduces to six (6) months the time period within which certain types of employment-related claims must be filed and waives any statute of limitations to the contrary, thereby significantly reducing the number of timely-filed claims and, consequently, the employer's potential exposure.
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As many of you know, there are various insurance policies available to protect against employment-related claims. Although some policies, such as employment practices liability (EPL) policies, cover a variety of claims, many cover only specific claims to the exclusion of all others. A recent decision from the U.S. Court of Appeals for the Fourth Circuit highlights some of the interesting issues that can arise in resolving employment claims covered by an insurance policy.
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On Sept. 29, 2006, the Food and Drug Administration ('FDA') issued a final guidance on quality systems for pharmaceutical companies: formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product and service requirements, improve customer satisfaction, and ensure continual improvement. The 'Quality Systems Approaches to Pharmaceutical Current Good Manu-facturing Practice Regulations' (the 'Guidance Document') is intended to help companies comply with the FDA's current Good Manufacturing Practices ('cGMP') regulations. The Guidance Document is part of the FDA's Pharmaceutical cGMPs for the 21st Century Initiative, a program that seeks to integrate quality systems and risk management approaches into existing manufacturing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
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Part One of this article discussed, inter alia, what the duty to preserve documents entails, when it begins, how a document retention policy can help protect against spoliation claims, and the consequences of failure to preserve documents. This installment addresses repetitive product liability litigation and what counsel should do when notified of a lawsuit.
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In <i>MedImmune v. Genentech</i>, decided Jan. 9, 2007, the U.S. Supreme Court swept away over a decade of Federal Circuit precedent to find that a licensee need not breach a patent license in order to file a declaratory judgment action for patent invalidity or unenforceability. The decision shifted substantial power from licensors to licensees: previously, a licensee had to choose the lesser of two evils. On one hand, the licensee could comply with the terms of a license agreement and forego any challenge to a patent, even if it felt the patent was not infringed, invalid, or unenforceable. On the other hand, the licensee could breach the license and challenge infringement, validity, and enforceability; in doing so, however, it exposed itself to potentially trebled damages and attorney's fees under 35 U.S.C. '' 284 & 285 and an injunction against future sales under 35 U.S.C. ' 283 if its challenge failed.
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The Privacy Rights Clearinghouse estimates that over 100 million records containing sensitive personal information have been involved in security breaches. This non-profit consumer organization has tracked these breaches on its website (www.privacyrights.org) beginning with the significant and well-publicized ChoicePoint breach in February 2005. As a result, over two-thirds of states enacted security breach notification laws governing the notification that a company must make in the event of a security breach. This article outlines the requirements for providing notification of a security breach under state security breach notification law by any company and the factors that a public company needs to take into account regarding whether to disclose a security breach under federal securities law.
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When the dust settles from the current round of discussions on increasing the federal minimum wage, the lowest paid of the country's non-exempt employees may or may not be earning an additional dollar or two per hour. Either way, the debate will have drawn the country's ' and the plaintiffs' bars' ' attention toward the lowest paid of our country's workers, and the climate will be right for those attorneys to begin focusing not only on how much non-exempt employees are being paid per hour, but also on whether these workers are being paid in a manner that is consistent with every intricate (and often contrary-to-common-sense) twist and turn of federal and state law.
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In <i>Arthur Andersen LLP v. United States</i>, 125 S. Ct. 2129, 235 (2005), the Supreme Court acknowledged the importance of records management policies that provide for the routine destruction of unneeded records under ordinary circumstances. It is, however, common knowledge that such policies should ordinarily be suspended once an investigation or litigation is reasonably anticipated. This is normally accomplished through the imposition of a 'litigation hold,' the process of notifying employees of their obligations to preserve all potentially relevant records while continuing the routine destruction of non-relevant active and archived data. This may be a company's first line of defense against claims of spoliation or obstruction. The failure to suspend routine purges of records in the face of litigation has contributed to the imposition of sanctions as high as $1.45 billion on companies.
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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.
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An end-of-year (Nov. 29) Delaware Chancery Court decision, <i>Esopus Creek Value LP v. Hauf</i>, is receiving a great deal of attention from corporate transactional and corporate restructuring attorneys alike. In Esopus, the Delaware Chancery Court prevented a financially sound company that was prohibited by federal securities law from holding a shareholder vote, because it failed to meet its reporting requirements, from executing an agreement outside of bankruptcy to sell substantially all of its assets under Section 363 of the Bankruptcy Code without first obtaining common stockholder approval as required under Section 271(a) of the Delaware General Company Law ('DGCL').