Fri, 17 May 2013 13:15:00 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all The latest newsletters from Crowell & Moring. 0b0482c9-fec7-43fe-a437-e14cb60ea2fc Fri, 17 May 2013 12:51:25 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Recent-Happenings-in-Advertising-Product-Risk-Management-May-2013 THE MONTH'S TOP SIX ADVERTISING & PRODUCT RISK MANAGEMENT DEVELOPMENTS 1) CPSC Proposed Significant Changes and New Obligations for Importers Relating to Certificates of Compliance The Consumer Product Safety Commission (CPSC) recently voted to approve a proposed rule amending 16 C.F.R. Part 1110 et. al., more commonly known as the '1110 rule.' Released in the Federal Register at 78 FR 28,080, the proposed amendment proffers numerous changes to the rule, including who is required to certify, what information is listed on the certificate, and when and how long the certificates must be issued and maintained. Importantly, if finalized, the rule would require electronic filing of certificates with each shipment as a requirement for imported products to make entry into the United States. In one of the most significant changes discussed below, the CPSC proposes to impose a certification requirement on common carriers, freight forwarders, and third party logistics ... 933e634f-4714-4d8f-bc0b-da15f25823e3 Thu, 16 May 2013 17:09:30 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Teaming-Agreements-Date-or-Marriage In Cyberlock Consulting, Inc. v. Information Experts, Inc. (E.D.Va. Apr. 3, 2013), the district court, based on "plain meaning," dismissed the sub's claim for breach of a teaming agreement by the prime for failure to subcontract with it after the award of a prime contract, holding that the subcontract provisions in the teaming agreement were "unenforceable agreements to agree" because the teaming agreement merely described the sub's scope of work as 49 percent of the functions and work in the prime contract, did not include  subcontract terms, and provided for termination of the teaming agreement if the parties could not agree on a subcontract after good faith negotiations. This decision confirms that precise drafting of teaming agreements can make the difference between an unenforceable date and an enforceable marriage. 4cad3d52-3af1-411c-bc2e-b565902e6be7 Fri, 17 May 2013 13:15:00 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/ALJ-Grants-CPSCs-Request-to-Name-Individual-CEO-as-Respondent-in-Aggressive-Prosecution-of-Buckyballs-Matter In a groundbreaking opinion issued on May 3, an Administrative Law Judge granted the Consumer Product Safety Commission's (CPSC) motion to name an individual as a respondent in its ongoing administrative action seeking a mandatory recall of high-powered magnet products. In the action, which the CPSC brought pursuant to Section 15 of the Consumer Product Safety Act (CPSA),2 the agency seeks an order that the magnet products contain a defect that creates a substantial product hazard. The CPSC also seeks to compel the three corporate respondents, including Maxfield and Oberton Holdings, LLC, marketer of Buckyballs and BuckyCubes, to recall those products and, among other things, pay for all of the costs associated with the recall. After Maxfield dissolved, the CPSC sought to add Craig Zucker as a respondent, both in his individual capacity and as CEO of Maxfield. In granting the Commission's motion, the ALJ relied heavily on his ... d22dc281-565b-4716-820c-782ba065accf Thu, 16 May 2013 14:40:15 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Patent-Law-Alert-A-Deeply-Divided-Federal-Circuit-Fails-to-Bring-Clarity-to-Patent-Eligibility-of-Software-Related-Inventions-in-Closely-Watched-Case In CLS Bank International v. Alice Corp. Pty. Ltd., Appeal No. 2011-1301 (Fed. Cir. May 10, 2013) (en banc), a closely watched appeal with over twenty amicus filings, a divided court reversed its previous panel decision and held that the claims at issue were not directed to eligible subject matter under 35 U.S.C. § 101. The court's one-paragraph per curiam opinion was followed by five separate non-precedential opinions and an "Additional Reflections" section by Chief Judge Randall Rader presenting diverging views on the proper analytical framework for assessing patent eligibility under 35 U.S.C. § 101. The failure of a majority of the court to agree on a particular analytical framework means that absent a decision by the Supreme Court, there will be much uncertainty as to whether any particular software patent claim is patent-eligible under 35 U.S.C. § 101. CLS Bank International (CLS) brought an action against Alice Corporation (Alice) ... ce048609-0f14-4d6d-9c62-d703850c8bc3 Wed, 15 May 2013 17:07:51 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/CPSC-Proposed-Significant-Changes-and-New-Obligations-for-Importers-Relating-to-Certificates-of-Compliance The Consumer Product Safety Commission (CPSC) recently voted to approve a proposed rule amending 16 C.F.R. Part 1110 et. al., more commonly known as the '1110 rule.' Released in the Federal Register at 78 FR 28,080, the proposed amendment proffers numerous changes to the rule, including who is required to certify, what information is listed on the certificate, and when and how long the certificates must be issued and maintained. Importantly, if finalized, the rule would require electronic filing of certificates with each shipment as a requirement for imported products to make entry into the United States. In one of the most significant changes discussed below, the CPSC proposes to impose a certification requirement on common carriers, freight forwarders, and third party logistics providers that assume the role of "importer of record" for direct to consumer shipments from foreign manufacturers.  Parties must comment on the proposed rules by July 29, ... 4302d102-4e7d-4ea8-b937-cd8f67c91880 Wed, 15 May 2013 15:23:40 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/California-Court-Dismisses-Complaint-Alleging-Airline-Privacy-Violations Can states regulate an airline's online and/or mobile application privacy policies? A California court has said the answer is no. In a victory for airlines, the Superior Court of California dismissed with prejudice a complaint against Delta Air Lines filed by the California Attorney General that alleged violations of the California Online Privacy Protection Act (CalOPPA). The order cites "the reasons set forth in Delta's papers" as grounds for the decision, endorsing, among other things, Delta's position that the Airline Deregulation Act preempts CalOPPA and that the federal government alone has the authority to regulate airline privacy policies. Judge Marla Miller explained the court's ruling in California v. Delta Air Lines, Cal. Super. Ct., No. CGC 12-526741, noting that "this case is, in effect, an attempt to apply a state law designed to prevent unfair competition, which regulates an airline's communication with consumers, and I think it's pre-empted." In ... fafdf644-0ed6-4e0d-ba52-59952985af8b Tue, 14 May 2013 13:58:27 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Sustainability-Disclosure-Proxy-Exclusion-the-Impact-of-the-SECs-Decision-in-PNC-Financial On February 13, 2013, the SEC rejected the determination by PNC Financial Services Group, Inc. that, like many companies before it, PNC could exclude a shareholder proposal relating to climate change from its annual proxy materials. Surprisingly to many observers, the Staff found that the proposal did not "deal with matters related to the ordinary business of PNC." The PNC decision comes after a rapid rise in the number of shareholders proposals that have sought greater disclosure from companies relating to climate change specifically and sustainability more generally. The PNC decision is noteworthy because it is a product of the pressures that have given rise to the push for greater disclosure and, at the same time, will likely accelerate them. By rejecting the so-called "ordinary course of business" exception, the SEC opened the door to other shareholder proposals that focus on climate change as well as to any other issue ... aea9a3b3-c73f-4533-9eba-4475d08fd652 Tue, 14 May 2013 17:38:23 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/NIST-Now-King-of-the-Hill-on-Cyber-Standards Following its key cyber role in President Obama's Executive Order No. 13636 issued this February, the National Institute of Standards and Technology (NIST) again seized the reins on federal cybersecurity standards on April 30, issuing the 457-page tome, Security and Privacy Controls for Federal information Systems and Organizations, that not only provides the "most comprehensive update" of the core information security controls, but also cuts new ground for cybersecurity standards governing mobile and cloud computing technology, applications security, supply chain protection, advanced persistent threats, and privacy controls for federal agencies and contractors. While some critics have sought to brush back prior NIST standards as too voluminous and technically dense, this latest publication underscores NIST's increasing dominance over cyber standards, as shown by both DoD and the Office of the Director of National Intelligence embracing this NIST update, thus paving the way for federal agencies to flow down new and expanded ... df2e5262-dc23-4837-b2ab-eb55a44677fd Mon, 13 May 2013 17:33:29 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Government-Receives-Proposals-When-They-Hit-the-Server In Insight Sys. Corp. v. U.S. (May 6, 2013), Judge Allegra of the CFC concluded that the FAR's "Government Control" exception to the "Late Is Late" doctrine can apply to electronic mail as well as paper submissions, even though the FAR does not specifically address electronic submissions. When an e-mail is received by an initial government server before the submission deadline, that e-mail is considered timely "received," even when a malfunction of the internal e-mail delivery system causes the e-mail not to be delivered to the Contracting Officer until after the deadline. 1865d1c8-fa1b-4706-99b2-53cfd9f67720 Wed, 08 May 2013 17:08:51 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/CFC-Denies-Fraud-Counterclaims-for-Lack-of-Scienter In response to a contractor's CDA claim for the cancelation of two purchase orders for printed circuit cards when the contractor manufactured the parts itself rather than providing the parts from specified approved sources, the government in Ulysses, Inc. v. U.S. (Apr. 30, 2013), brought counterclaims for fraud under the False Claims Act, the fraud provision of the Contract Disputes Act, and the Forfeiture of Fraudulent Claims Act. The CFC denied them all, holding that the contractor did not act in reckless disregard of the truth or falsity of its claims because neither the RFQ nor the contractor's quotation leading to the purchase order specified a particular source and, therefore, its erroneous interpretation of the purchase orders "was not so implausible as to be frivolous" and because it had advised the government that it believed it was an approved source, "making this a classic case for application of the Government ... b880e75a-857e-408b-bbbf-7dcc4e906c55 Tue, 07 May 2013 09:40:36 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/IRS-Details-College-and-University-Audit-Issues The IRS recently released its final report on its Colleges and Universities Compliance Project. The report details the types of audit adjustments that were made on examination of several colleges and universities that were subjects of the project. Unrelated businesses and executive compensation were among the major focuses. The stated rationales for the adjustments will be of interest to colleges and universities generally. The IRS began the project in 2008 by distributing questionnaires to 400 randomly selected institutions. In 2010, the IRS chose 34 of the institutions for audit because the questionnaire responses indicated a potential for noncompliance. Because these audited schools were not selected at random but instead represented high audit potential, the adjustments made are not representative of educational institutions generally. The IRS proposed unrelated business income tax (UBIT) adjustments for 90 percent of the audited schools. The IRS found that several schools claimed that some ... 14017eb4-53b1-47a7-b0a5-4f1f107f3cb0 Tue, 07 May 2013 12:14:59 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Proposed-Amendment-to-Delaware-Law-May-Lead-to-Increased-Use-of-Tender-Offer-Structure-in-M-A-Transactions The Delaware State Bar Association has proposed an amendment to the Delaware General Corporation Law (DGCL) that is intended to streamline the process for completing tender offers and could lead to an increase in the use of the tender offer structure over long-form mergers. If adopted as proposed, the amendment will apply to merger agreements entered into on or after August 1, 2013. The two main acquisition structures in M&A deals involving public Delaware target companies are the long-form merger and the two-step tender offer, which consists of a tender offer followed by a back-end merger. Assuming no other timing issues, tender offers can typically be completed more quickly than long-form mergers, but require the second step in order to obtain 100 percent ownership of the target. If at least 90 percent of the outstanding shares of each class of voting stock are purchased in the tender offer, a short-form ... 9a628d5b-c2c4-4898-9bec-ec9f1503b291 Wed, 08 May 2013 14:43:18 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Marketplace-Fairness-Act-of-2013-Where-Is-The-Income-Tax-Safe-Harbor Legislation passed by the U.S. Senate on May 6, 2013 would impose sales tax collection obligations on retailers with no physical presence in a state but would not provide a needed income tax safe harbor.  In what may prove to be one of its most bi-partisan moments in recent years, the U.S. Senate passed S. 743 (The Marketplace Fairness Act of 2013) by a large margin: 69 – 27. The Bill would require remote sellers with more than $1 million in total sales to collect sales taxes in states that adopt sales tax simplification measures. These simplification measures require one-stop tax compliance, one-stop auditing, standardization of what is subject to tax, and 90-day notice of rate changes.  Logic tells us that virtually every state will adopt these sales tax simplification measures, at least for remote sellers. This is a development that over time may lead to sales tax simplification ... e21bda42-b3da-4653-8642-1b4d362f5503 Mon, 06 May 2013 13:23:14 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/New-Form-I-9-Employment-Eligibility-Verification-Form-Required-as-of-May-7-2013 Effective May 7, 2013, a revised Employment Eligibility Verification Form (Form I-9) becomes mandatory and all employers must begin using the new Form as of that date. Among the changes implemented on the new Form I-9 are new data fields for the employee to complete, such as e-mail address, telephone number and foreign passport number. Although the new Form I-9 has not changed significantly from its prior iteration, employers should review their practices to ensure compliance with the requirements. Timing The Form I-9 must be completed for every new hire, even if the employment is only for a short period of time. Newly hired employees must complete and sign Section 1 of the Form I-9 no later than the first day of employment. It is important to note that Section 1 should never be completed before the employee has accepted a job offer. Employers must make sure that ... 5bac898c-dd9e-4d87-a981-736cfe85f3cd Mon, 06 May 2013 12:42:31 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Managed-Care-Lawsuit-Watch-May-2013 This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring LLP. If you have questions or need assistance on managed care law matters, please contact Art Lerner or any member of the health law group. Please click to view the full Crowell & Moring Managed Care Lawsuit Watch archive. Cases in this issue: United States v. Blue Cross Blue Shield of Michigan U.S. Airways, Inc. v. McCutchen U.S., ex rel. Upton v. Family Health Network, Inc. Garcia v. Pacificare of California, Inc. Morris v. Humana Health Plan, Inc. In re Neurontin Marketing and Sales Practices Litigation ... dabf8bb1-2c3d-4336-8f8a-bcf1eb69b865 Fri, 03 May 2013 14:41:05 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/OOPS-Preview-on-TV Tune in this Sunday to Government Contracting Weekly (7 am, WUSA Channel 9) to hear Crowell & Moring's own Angela Styles and Amy O'Sullivan discuss several key topics of interest, including sequestration (and its impacts on bid protests and the M&A market) and reactions to the new small business legislation, that will be given greater attention at our 29th Annual Ounce of Prevention Seminar, May 15th and 16th at the Renaissance Hotel in D.C. Further information on the conference, including a detailed agenda that covers the waterfront of the "hot" issues in the government contracts marketplace today, is provided here. c8f58442-e691-4d55-b4cf-e8ae97168b7b Fri, 03 May 2013 14:22:58 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/This-Month-in-International-Trade-April-2013 THIS MONTH'S TOP FIVE DEVELOPMENTS 1) BIS and DDTC Issue First Final Rules to Implement the Administration's Export Control Reform Initiative To implement the President's Export Control Reform Initiative, the Department of State's Directorate of Defense Trade Controls (DDTC) and the Department of Commerce's Bureau of Industry and Security (BIS) concurrently issued the first in a series of long-awaited final rules amending the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR) by transferring certain less sensitive items from the United States Munitions List (USML) to the Commerce Control List (CCL), and creating a more positive control list that eliminates, where possible, "catch all" controls. The first final rules revised USML Category VIII (Aircraft and Related Articles) and the addition of USML Category XIX (Gas Turbine Engines and Associated Equipment), as well as the unchanged Categories XVII (Classified Articles, Technical Data, ... db1dea15-3784-41e8-8eee-a9f8593afa7b Thu, 02 May 2013 10:32:14 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/DoD-Tightens-Counterfeit-Prevention-Policy On April 26, 2013, DoD issued an Instruction to establish policies to prevent the introduction of counterfeit material at any level of the DoD supply chain and to seek restitution for critical failures and damages caused by such material. DoD component heads are tasked with integrating the policy into contract requirements and procedures, procuring critical material only from suppliers that meet appropriate counterfeit avoidance criteria or applying additional risk management measures when such suppliers are not available, using sampling techniques and material testing for detection, and reporting all suspected or confirmed occurrences. 8ae0632b-d54f-48a3-9fa8-bf340081ae05 Wed, 01 May 2013 15:03:18 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Supreme-Court-Endorses-Significant-Changes-To-Rule-45-Third-Party-Subpoena-Process The Supreme Court recently transmitted to Congress amendments to Rule 45 of the Federal Rules of Civil Procedure that will have a significant impact on third party discovery in federal court. Absent congressional action, the amendments will take effect December 1. Among other changes, the amended rule will require all third party subpoenas to issue from the court where the litigation is pending. The rule will allow a subpoena to be served anywhere in the United States. This change will greatly simplify the rule, which currently requires a subpoena for trial testimony to issue from the court for the district where the trial is to be held, a subpoena for deposition testimony to issue from the court for the district where the deposition is to be taken, and a subpoena for the production or inspection of documents to issue from the court for the district where production or inspection is to be ... 634ea639-c336-4a56-a692-e095148cc302 Tue, 30 Apr 2013 12:10:53 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Much-Anticipated-Decision-On-Rates-To-License-Standard-Essential-Patents-Issues The first federal court decision setting a reasonable and non discriminatory (RAND) licensing rate for standard-essential patents (SEPs) issued last week in the closely watched Microsoft v. Motorola case in the Western District of Washington. Judge James L. Robart's 200-plus page ruling sets a framework to determine RAND rates, relying heavily on pool rates, and is expected to be argued in future disputes regarding RAND commitments and SEPs. The case involves Motorola patents essential to wireless networking and video coding standards1, which are encumbered by RAND obligations as a result of Motorola's participation in the standard-setting activities related to those technologies. Microsoft, manufacturer of the Xbox, which reads on the standards, sued Motorola for allegedly breaching its RAND obligations by demanding as a license fee 2.25 percent of every Xbox sale. To decide whether Motorola had breached its RAND obligation, the court determined that it must first establish a RAND rate. To ... 2aa2068a-98d4-4b1c-b1f7-7f9eb6eefce1 Mon, 29 Apr 2013 14:45:19 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/European-Antitrust-Developments-Dec-2012-to-Mar-2013 Welcome to Crowell & Moring's first quarterly update on  European antitrust developments. Below we have provided concise and easily-digestible summaries of the top 5-10 European antitrust developments arising out of the EU and the following key jurisdictions: Germany, UK, France, Belgium and the Netherlands. Where available, we will provide links to the matters for further information. If you would like more detail on any of these developments – or you have any other comments on the service – do get in touch and let us know. Mergers 1) European Commission, Hutchison 3G Austria/Orange Austria (M.6497, 12 December 2012)  – the Commission approved Hutchison 3G's acquisition of Orange's mobile telephony business in Austria after a Phase II investigation and subject to commitments. This despite the parties having a combined market share of only around 22% and the new entity being only the No.3 in the market. Commitments included the ... 08db37c5-1eb1-4d40-a580-0597bcee9139 Fri, 26 Apr 2013 10:20:10 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Citizen-Suit-Watch-Stormwater-Report-Supreme-Court-Holds-That-Stormwater-Discharges-From-Logging-Roads-Do-Not-Require-Clean-Water-Act-Permits-Federal-District-Court-Rejects-a-Similar-Stormwater-Citizen-Suit-Against-A-Utility On March 20, 2013, the Supreme Court held, in Decker v. Northwest Environmental Defense Center,1 that the Clean Water Act and the industrial stormwater regulations from the U.S. Environmental Protection Agency (EPA) did not subject stormwater discharges from logging roads to a mandatory permit requirement. In reaching this conclusion, the Court deferred to EPA's interpretation that the regulations did not treat timber harvesting as an "industrial activity." Justice Scalia, dissenting, argued that such deference was not warranted and would have reached the opposite conclusion.  Earlier that month, a federal district court in California granted summary judgment for a defendant in a similar citizen suit, Ecological Rights Foundation v. Pacific Gas & Electric Company, No. C 10-0121 (N.D. Cal. Mar. 1, 2013). In that case, the plaintiff argued that EPA's industrial stormwater regulations require permits for stormwater discharges from facilities used to store vehicles, equipment, materials and supplies, and to ... 7a05e5a7-7a48-4644-86d4-d628ae86945a Fri, 26 Apr 2013 13:55:03 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Supreme-Court-Reinforces-Importance-of-Uniform-Application-of-Clear-ERISA-Plan-Language-in-US-Airways-v-McCutchen Last week, the U.S. Supreme Court issued its opinion in U.S. Airways v. McCutchen, No. 11-1285, 569 U.S. __ (Apr. 16, 2013), and resolved a Circuit split on a question left unanswered by two previous rulings – Great-West Life & Annuity Ins. Co. v. Knudson, 534 U.S. 204 (2002) and Sereboff v. Mid Atlantic Med. Services, Inc., 547 U.S. 356 (2006) – involving the equitable enforcement provision of ERISA § 502(a)(3) (29 U.S.C. § 1132(a)(3)) ("§ 502(a)(3)"). The open question was this:  if § 502(a)(3) entitles plan administrators to seek reimbursement from a beneficiary on theories of equitable relief in certain scenarios, can beneficiaries likewise claim traditional equitable defenses to limit or prevent reimbursement? A majority of Circuits had favored the explicit terms of the plan and not permitted equitable defenses to prevent reimbursement under the terms of the plan, but a minority (including the Third Circuit in U.S. Airways) ... f3627eaa-a0ec-41c1-a0a0-796fbace2672 Fri, 26 Apr 2013 16:23:20 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Supreme-Court-Holds-that-FLSA-Collective-Action-Must-be-Dismissed-Because-Named-Plaintiffs-Claims-Became-Moot-After-Her-Rejection-of-Offer-of-Judgment For those hoping the Supreme Court would bless the "pick off" strategy used by some employers in response to Fair Labor Standards Act (FLSA) collective actions, last week's decision in Genesis Healthcare Corp. et al. v. Symczyk offers cold comfort. The ultimate question – whether an employer's unaccepted Rule 68 offer of judgment to a named plaintiff moots a collective action – was left for another day. The majority opinion relied on Symczyk's concession that her individual claim was moot in holding that this admission required dismissal of the putative FLSA collective action in this particular case. In so doing, the Court failed to address the split among the lower courts regarding the viability of the "pick off" strategy in the context of unaccepted offers of judgment. The Court's 5-4 opinion did offer a glimmer of hope for employers, in holding that if the named plaintiff's claim is in fact ... 14adb5c8-477d-4373-9d25-684523ab02dc Tue, 23 Apr 2013 12:25:55 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Review-of-Competition-Law-Fines-by-German-Courts-Differences-to-the-Review-by-European-Courts - German court increases fines against members of liquefied gas cartel - German Federal Supreme Court clarifies 10% fine limit In a decision of 15 April 2013, the Higher Regional Court of Düsseldorf increased the cartel fines on liquefied gas suppliers to a total of EUR 244 million or to up to 85% more than what has been previously imposed by the German competition authority in its administrative decision. In addition, in a decision of 26 February 2013, the German Federal Supreme Court held that the 10% limit for fines imposed on undertakings constitutes the upper limit of the applicable scale of fines, not just a capping threshold as the 10% limit is interpreted to be under EU competition law. These two decisions highlight differences that still prevail in Europe between the enforcement of competition laws at European and at national level. Increased risk of reformatio in peius? ... 6288acca-bb61-45c3-9bf5-bfa7ea127b1a Mon, 22 Apr 2013 15:39:42 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/ICANN-Appoints-a-Second-URS-Provider Background The Uniform Rapid Suspension system (URS) is a (yet to be implemented) rights protection mechanism established by ICANN that facilitates the rapid suspension of domain names in clear-cut cases of trademark infringement within the Internet's new gTLDs. It is intended to complement the existing Uniform Domain-Name Dispute Resolution Policy (UDRP) by offering a lower-cost, faster path to resolution. Until now, the National Arbitration Forum (NAF) was the only URS service provider appointed by ICANN. ICANN's latest communication on the subject ICANN signed a Memorandum of Understanding with the Asian Domain Name Dispute Resolution Centre (ADNDRC), establishing the ADNDRC as a URS provider. ADNDRC is an established Uniform Domain Name Dispute Resolution Policy (UDRP) provider, with offices in Beijing, Hong Kong, Seoul, and Kuala Lumpur. It has a proven track record of administering UDRP cases since its appointment as a UDRP provider in 2001. ICANN ... 04c1182d-809d-4df1-8b49-60965aa29cf7 Thu, 25 Apr 2013 13:28:07 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Best-Value-Determination-Doesnt-Comply-with-High-Value-Sole-Source-IDIQ-Requirements In the first published decision to interpret the selection criteria applicable to high value, sole-source, IDIQ contract awards, in CW Gov't Travel, Inc. v. U.S. the Court of Federal Claims made clear that the government is required to determine, per FAR 16.504(c)(1)(ii)(D), that the awardee is the only source that is qualified and capable of performing the work at a reasonable price before awarding a sole-source, IDIQ contract over $103 million. Because the government had based its award decision on best value criteria instead, the CFC ruled for the protester (see blog for further discussion). 983e216b-9eb4-4f6e-b48f-56acd5ba7eb6 Thu, 25 Apr 2013 15:51:32 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Recent-Happenings-in-Advertising-Product-Risk-Management-April-2013 IMPORTANT HEADLINES YOU MAY HAVE MISSED 1) Supreme Court Hears Latest Preemption Arguments from Drug Manufacturers On March 19, 2013, the Supreme Court of the United States heard oral argument in Mutual Pharmaceutical Co. v. Bartlett, Docket Number 12-142, to decide whether federal law preempts state law design defect claims against manufacturers of generic drugs. The Bartlett case is the latest battleground in the fight over whether and how both brand-name and generic pharmaceutical manufacturers may be held liable for injuries allegedly caused by their products. In 2009, the Supreme Court ruled in Wyeth v. Levine, 555 U.S. 555 (2009), that federal law did not preempt state-based failure to warn claims brought against brand-name pharmaceutical manufacturers. Just two years later, however, in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Court cabined its prior holding, ruling that federal law preempted the same failure to ... 27ce3d1f-ff20-44ea-a394-8fd504c9b5c2 Wed, 17 Apr 2013 14:52:58 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/California-District-Court-Finds-Lawful-Health-Plans-Categorical-Exclusion-of-Certain-Types-of-Prosthetic-Devices The United States District Court for the Central District of California denied Plaintiff's motion for summary judgment and granted summary judgment in favor of PacifiCare, on an ERISA claim for benefits for myoelectric prosthetic devices. Plaintiff sought coverage for replacement of myoelectric prosthetic devices, which PacifiCare denied based on a specific exclusion in the plan for myoelectric devices. Plaintiff argued that California Health & Safety Code § 1367.18 requires that when health plans offer prosthetic coverage, that coverage must include all medically necessary original and replacement devices when prescribed by a qualified medical professional. Plaintiff argued that PacifiCare's categorical exclusion for myoelectric devices violates the statute because it excludes coverage for a medically necessary replacement device prescribed by Plaintiff's physician. PacifiCare argued that it is permitted to exclude specific types of prosthetics devices or services under the plain language of the statute. The statute authorizes the plan and ... f0bd6119-17e5-4baa-b3ce-d79d38e32003 Thu, 18 Apr 2013 10:07:45 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Supreme-Court-Denies-Review-of-Third-Circuit-Decision-That-MA-Organizations-Have-a-Direct-Right-of-Recovery-Under-the-Medicare-Secondary-Payor-MSP-Act On April 15, 2013, the U.S. Supreme Court denied certiorari to review a Third Circuit decision that Medicare Advantage Organizations (MAOs) have a direct right of recovery against primary payors under the Medicare Secondary Payer (MSP) Act, 42 U.S.C. § 1395y(b).  The case is GlaxoSmithKline LLC v. Humana Medical Plans, Inc., case number 12-690 in the U.S. Supreme Court.  The petition arose from a suit filed by Humana Medical Plan, Inc. and Humana Insurance Company (Humana), as an MAO, against GlaxoSmithKline, L.L.C. and GlaxoSmithKline plc (GSK).  Humana's suit alleged that GSK was obligated to reimburse Humana for expenses it incurred covering insureds that were injured by GSK's diabetes drug, Avandia.  Section 1395y(b)(3)(A) establishes "a private cause of action for damages (which shall be in an amount double the amount otherwise provided) in the case of a primary plan which failed to provide for primary payment (or appropriate reimbursement) ... 87e79abb-f69d-4b3b-816f-46ad0a1e67eb Tue, 16 Apr 2013 14:09:26 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Reform-Initiative-Becomes-Reality Today, the U.S. Departments of State and Commerce simultaneously published final rules to take effect in 180 days representing the initial step in completing the first phase of the Export Control Initiative: the creation of a brighter line between the U.S. Munitions List (USML) and the Commerce Control List (CCL). These rules include a uniform, but controversial, definition of "specially designed," a revised version of Category VIII (Aircraft & Related Articles) and the associated new Category XIX (Gas Turbine Engines & Associated Equipment), the unchanged Categories XVII (Classified Articles Not Otherwise Enumerated) and XXI (Defense Articles Not Otherwise Enumerated), and a licensing transition plan for those items moving from the USML to the CCL. 65fbd2ac-d5ee-45e2-923e-d4ff43a3bc3a Mon, 15 Apr 2013 10:40:25 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/DOJ-Antitrust-Division-Announces-Changes-to-Corporate-Plea-Agreement-Policy Late last week, the Department of Justice Antitrust Division (the "Division") announced two changes to long-standing practices regarding individual "carve-outs" in corporate plea agreements for criminal antitrust violations. The changes are significant because they will impact corporate employees and executives who remain under investigation by the Division following a corporate plea, and could shift the dynamics of corporate plea negotiations in some cases.  Bill Baer, the Assistant Attorney General of the Antitrust Division, announced that the Division will abandon its practice of naming the individuals who are "carved out" of corporate plea agreements, recognizing that publicly identifying uncharged individuals was not "appropriate." Baer also commented that the Division will only carve out those individuals who it believes to be culpable and are thus potential targets of the investigation.  The Antitrust Division's plea agreements for criminal antitrust violations customarily include language that includes current and former corporate employees and ... 19952add-663b-4ca7-9141-833d0b729608 Fri, 19 Apr 2013 11:40:32 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Study-Finds-Lead-Contamination-in-Rice-Imports-Could-Litigation-Be-Close-Behind A recently-published Monmouth (NJ) University study claims to have detected high levels of lead in imported rice. These preliminary findings, which follow media reports last fall about arsenic contamination in rice, pose new regulatory and litigation risks for manufacturers, importers, distributors and, perhaps, even retailers of foods and other consumer and commercial products made with imported rice. Although imports account for only seven percent of rice consumed in the U.S., imports of rice and rice flour have increased by more than 200 percent since 1999, a trend that is likely to continue as more consumers seek to limit or eliminate gluten from their diets. In addition to whole grain rice and rice flour, rice is a common ingredient in a wide array of food products, ranging from infant formula and baby food to ethnic foods. Rice and its byproducts are also often contained in non-food items such as building ... 8aa58d15-fa86-4bc5-8124-d305daa1f5cc Thu, 11 Apr 2013 16:26:13 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Conflicting-Court-Decisions-Highlight-Difficulty-of-Prosecuting-Foreign-Corporations-for-Economic-Espionage-and-Trade-Secrets-Theft The Obama administration has made the protection of U.S. intellectual property a priority, as we have reported in prior alerts. But achieving that goal is rife with challenges, including the practical barriers to criminal prosecution of foreign corporations for economic espionage and trade secrets theft. Among those barriers is Rule 4 of the Federal Rules of Criminal Procedure, which specifies how jurisdiction over a foreign corporate defendant may be achieved through service of process. Courts are only now beginning to struggle with the intersection of trans-national corporate crime in the internet age and Rule 4, which is woefully out-dated. Two recent conflicting court decisions highlight this disconnect. In February, a judge in the U.S. District Court for the Eastern District of Virginia issued a lengthy memorandum opinion analyzing the application of Rule 4 to the government's attempts to serve an indictment and summons on the corporate defendant in United States v. Kolon Industries, ... efafa362-07db-4657-ade5-feb1fd5c68a7 Thu, 11 Apr 2013 11:42:07 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/CMS-and-OIG-Propose-Amendments-to-the-Electronic-Health-Records-Exception-and-Safe-Harbor The Centers for Medicare & Medicaid Services (CMS) and Office of Inspector General-HHS (OIG) proposed amendments this week to the electronic health records Stark Law exception and Anti-Kickback Statute safe harbor. As is the case for the current exception and safe harbor requirements, CMS's and OIG's proposed changes closely parallel one another. The CMS rule may be found here; the OIG rule may be found here. The deadline for comments is June 10, 2013. Sunset to Be Extended, But How Long? The current exception and safe harbor each have a sunset at the end of 2013, after which EHR technology cannot be donated under those particular protections. The proposed rules each would  extend the sunset to December 31, 2016. The agencies selected this date because 2016 is the last year to receive a payment under, or initiate participation in, the Medicare EHR Incentive Program. But, in the alternative, ... 7341e58f-f79a-4b18-92e6-0dafd1d0db2a Wed, 10 Apr 2013 13:53:44 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Delaware-Chancery-Court-Rejects-Claim-That-Article-9-Sale-Was-Not-Conducted-in-a-Commercially-Reasonable-Manner The process of disposing of collateral in a public or private sale under Article 9 of the Uniform Commercial Code was designed to be quick and cost-effective. Under the right circumstances, an Article 9 disposition may be a good alternative to a potentially more costly and time-consuming asset sale under Section 363 of the Bankruptcy Code. But the drafters of Article 9 left room for interested parties to challenge an Article 9 sale. A frequently litigated challenge is based upon allegations that a sale had not been conducted in a "commercially reasonable" manner. In Edgewater Growth Capital Partners LP v. H.I.G. Capital, Inc., et al.1, Edgewater, an equity sponsor and guarantor of the borrower's debt obligation, challenged, among other things, the commercial reasonableness of an Article 9 asset sale. The court ultimately rejected the challenge, but only after costly and protracted litigation. Pendum, a company which had been ... f30fe684-a74c-4de1-8c6d-225027ee6aee Wed, 10 Apr 2013 11:44:52 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Initial-Loading-of-Critical-Software-May-Not-Always-Define-Country-of-Origin On April 3, 2013, the Bureau of Customs and Border Protection (CBP) issued two final determinations on the country of origin for complex electronic equipment which demonstrate the role that loading of U.S.-origin system software or firmware can play in identifying the country of origin under the substantial transformation test applicable to the Trade Agreements Act. In Country of Origin of Ultrasound Systems (a matter handled by Crowell & Moring), CBP concluded that the country of origin was the U.S. despite an initial system software load to the electronics module in China, when complex components from multiple countries subsequently were combined in the U.S. along with the download of the final system software, whereas in Country of Origin of HP LaserJet Enterprise 500 Color M551 Printer and Fax Machine, CBP concluded that loading U.S.-origin firmware along with a simple (7-minute) final assembly operation in Mexico did not substantially transform the ... f52ed114-0399-4f97-a363-4fd72edad2e5 Tue, 09 Apr 2013 17:00:11 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Animus-Unnecessary-for-Improper-Termination In a decision that catalogued and continued the confusion in the Federal Circuit's case law concerning when a termination for convenience may be challenged as improper and, thus, give rise to breach damages, the CFC in Tigerswan, Inc. v. U.S. (Apr. 2, 2013) rebuffed the government's position that, to prevail, the contractor must always show a specific intent to harm the contractor. It then ruled that the contractor could not show a breach of good faith duties because the contract contained a termination clause, but then also ruled that actionable bad faith is shown if the government has engaged in improper self-dealing (which tracks the Restatement's definition of breach of good faith duties). fd0e891a-6504-41a2-939f-85d7f72bc0ae Mon, 08 Apr 2013 15:13:18 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Regulation-FD-in-the-Social-Media-World-The-Old-Rules-Still-Apply-to-the-New-Technology On April 2, 2013, the SEC clarified in a Report of Investigation1 that posts by a company on its Facebook page, Tweets via its Twitter account, or disclosures through other forms of social media may satisfy the public disclosure requirement of Regulation FD (Fair Disclosure), affirming that companies should approach such communications as they would any other electronic dissemination of material non-public information: carefully. Prior to using social media for corporate disclosures of information potentially material to an investment decision, companies should advise the investing public about the methods of communication that it might use to make these disclosures, including corporate web sites, social media, blogs, or otherwise. Further, the corporate web site should clearly indicate how those methods of communication can be accessed. Background of the Report Investigating the application of Regulation FD to a Facebook post by Netflix CEO Reed Hastings, the SEC issued the Report ... 30b15575-82fc-44a0-b940-dab0f3e994a4 Wed, 10 Apr 2013 13:42:54 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Federal-Court-Rules-Hospitals-Contracting-with-FEHBP-HMO-are-Subcontractors-Subject-to-Federal-Affirmative-Action-Requirements Judge Paul Friedman of the United States District Court for the District of Columbia recently affirmed a determination by the U.S. Department of Labor (DOL) Administrative Review Board (ARB) that three hospitals that contracted with a health maintenance organization (HMO) were federal subcontractors under the HMO's contract with the United States Office of Personnel Management (OPM) to provide medical services and supplies to federal employees. UPMC Braddock v. Harris, No. 1:09-cv-01210-PLF (D.D.C. Mar. 30, 2013). As a result, the court found the hospitals were required to comply with affirmative action requirements for government contractors and subcontractors and subject to audit by DOL's Office of Federal Contract Compliance Programs (OFCCP). Judge Friedman's long-awaited decision has broad implications for health care providers, including those that hold contracts with HMOs who, in turn, hold contracts with certain federal health care programs, even when the provider-HMO contract makes no reference to any government contracting obligations. ... 8b2bc3ab-36b8-4888-b44d-e4146d72a7fb Fri, 05 Apr 2013 17:22:26 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Christian-Doctrine-Applied-to-Subcontract As discussed in more detail in a Crowell Alert issued today, the U.S. District Court for D.C. in UPMC Braddock v. Harris (Mar. 30, 2013) relied on the Christrian doctrine, a rule derived from case law that allows for the inclusion in a contract by operation of law of omitted government contract clauses expressing a significant public procurement policy, to incorporate affirmative action clauses into a subcontract between certain hospitals and a managed care organization with a Federal Employees Health Benefits Program prime contract. This is the first instance of which we are aware that a court has used the Christian doctrine to incorporate federal procurement obligations into a subcontract. b440836a-cb69-4537-a494-0515c98376d3 Thu, 04 Apr 2013 10:43:36 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Coal-Loading-Facility-and-Railroad-Win-Federal-Court-Endorsement-of-Clean-Water-Acts-Permit-Shield-Defense-and-Refusal-to-Expand-Clean-Water-Act-to-Wind-Borne-Dust In a decision addressing fundamental Clean Water Act (CWA) issues, the federal district court in Alaska dismissed the principal claims in a citizen-suit brought against Aurora Energy Services LLC (AES) and the Alaska Railroad Corporation (Alaska Railroad) Alaska Community Action on Toxics v. Aurora Energy Services, LLC, No. 3:09-cv-00255-TMB (D. Alaska Mar. 28, 2013). The plaintiffs, two environmental groups, claimed that AES and Alaska Railroad had violated the CWA by discharging coal in various forms (including coal "carry back" and airborne dust), without a permit. Relying on the statute's "permit shield" provision and "point source" requirement, the court dismissed all but one of plaintiffs' claims and largely granted defendants' motion for summary judgment. Background Two organizations, Alaska Community Action on Toxics and the Alaska Chapter of the Sierra Club, initiated this suit in 2009 against Alaska Railroad and AES, as the owner and operator respectively of the Seward Coal ... a8d1ff44-0663-476d-a288-92ea54fd9d35 Wed, 03 Apr 2013 16:24:11 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Regulatory-Reform-of-the-UK-Financial-Services-Industry For many years the principal regulator for the UK financial services industry has been the Financial Services Authority (FSA). As a result of the FSA's perceived failings during the financial crisis and subsequent recession, the FSA was this week abolished in its current form and replaced by: the Prudential Regulation Authority (PRA), which sits as an independent subsidiary of the Bank of England and is responsible for the regulation of financial institutions of systemic importance such as banks and building societies; the Financial Conduct Authority (FCA), which has inherited most of the regulatory roles previously carried out by the FSA including responsibility for the conduct of all businesses which were regulated by the FSA; and the Financial Policy Committee (FPC), which sits in the Bank of England and will oversee ... 2a35c8ff-86ca-4a8d-8371-b279f99e5307 Tue, 02 Apr 2013 10:52:12 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/New-York-City-Employers-Beware-New-Law-Prohibiting-Unemployment-Discrimination-to-Take-Effect-in-June The New York City Council has enacted sweeping legislation that amends New York City's Human Rights Law (NYCHRL) by adding unemployment status as a new protected category. Introductory Bill No. 0814-2012-A. Pursuant to this new unemployment discrimination law ("Law"), which applies to employers with four or more employees and takes effect on June 11, 2013, "an employer, employment agency, or agent thereof shall not base an employment decision with regard to hiring, compensation or the terms, conditions or privileges of employment on an applicant's unemployment." The Law further prohibits employers and employment agencies covered by the NYCHRL from including in an advertisement for any job vacancy provisions indicating that "being currently employed is a requirement or qualification for the job" or that individuals will not be considered for employment "based on their unemployment." Under this Law, the terms "unemployed" and "unemployment" are defined as "not having a job, being available for work, ... a7543a6e-b04d-48fc-8999-20e19c76b4d2 Tue, 02 Apr 2013 17:28:54 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Arbitrability-Is-for-the-Arbitrator-to-Decide In U.S. ex rel. Beauchamp v. Academi Training Center, Inc. (E.D. Va. Mar. 29, 2013), in which C&M represented the defendant, the court, after dismissing both FCA claims a week earlier, stayed the relators' retaliation claims, despite their allegations that the arbitration provision in their independent contractor agreements were unconscionable and that arbitrability was for the court to decide. The court held that the parties had delegated the question of arbitrability to the arbitrator with "clear and unmistakable intent" by incorporating the AAA Commercial Rules into the agreements, a delegation which relators failed to challenge, thus leaving it to the arbitrator to decide whether other terms of the agreements made the arbitration provision unconscionable and unenforceable. 5888c855-24d9-4da5-8a01-619309548715 Mon, 01 Apr 2013 14:14:54 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Whistleblowers-FCA-Claims-Fail-Public-Disclosure-and-First-to-File-Bars In U.S. ex rel. Beauchamp v. Academi Training Center, Inc. (E.D. Va. Mar. 21, 2013), in which C&M represented the defendant, the court dismissed all claims that Academi had violated the False Claims Act by allegedly falsifying its labor invoices and failing to qualify Afghanistan-based security personnel on certain weapons properly. The court held that public disclosure barred both claims because they either had been publicly disclosed in the media or in an earlier qui tam action brought against Academi (resulting in a judgment in favor of Academi with C&M defending), but also that the labor claim was precluded by the first-to-file bar because it was based on the underlying facts in a related and earlier-filed qui tam suit that was pending when the Beauchamp complaint was filed. 16070a18-0de9-4062-abe4-bbd15f9238dc Fri, 29 Mar 2013 11:35:46 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/This-Month-in-International-Trade-March-2013 THIS MONTH'S TOP FIVE DEVELOPMENTS 1) EU Initiates Anti-dumping Investigation of Solar Glass Imports from China On February 28, the European Commission initiated an anti-dumping investigation into imports of solar glass from China, following the submission of a complaint by EU ProSun Glass, an association of EU solar glass producers, on January 15, 2013. The complaint provides prima facie evidence that a high volume of dumped Chinese imports of solar glass has caused material injury to the EU. Chinese products account for over 70% of all solar glass imports into the EU and import volumes have significantly increased over the last years.  The EU investigation will take 15 months. The latest date for imposition of provisional measures is November 28, 2013, i.e. nine months after initiation; definitive measures must be imposed by May 27, 2014 at the latest. The investigation into imports of solar glass ... b48eacfe-2aab-4bb5-a9c9-a5fa9d1330c1 Fri, 29 Mar 2013 15:09:32 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/401k-Plan-Investment-Selection-Triggers-ERISA-Violation On March 21, the Ninth Circuit issued its long-awaited opinion in Tibble v. Edison International et al. Tibble affirmed the district court's conclusion that the fiduciaries of Edison International's 401(k) plan breached ERISA's duty of prudence in the process used to select certain mutual funds as investment options. The court's 50 page opinion addresses several important substantive and procedural issues frequently encountered in 401(k) plan "excessive fee" litigation. Like many of the "excessive fee" cases filed against employers across the country, Tibble has a long and complicated procedural history. The biggest news from last week's opinion is the Ninth Circuit's affirmation of a judgment, following a three day bench trial, that Edison breached ERISA's duty of prudence by offering three specific retail-class mutual funds. The trial court determined that the California electric utility's investment selection process did not properly investigate the alternative of offering lower-fee institutional-class funds available from ... b6a887ea-5b90-4147-a14f-c2582a911216 Fri, 29 Mar 2013 17:31:32 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/NHTSA-Successfully-Defends-Its-Roof-Crush-Resistance-Strength-Requirements On March 28, 2013, the Sixth Circuit reinforced the high bar a petitioner faces in contesting rules issued by the National Highway Traffic Safety Administration (NHTSA), rejecting a trucking trade organization's challenge to 2009 roofing safety standards promulgated by the agency.   In National Truck Equipment Association v. National Highway Traffic Safety Administration, No. NHTSA-2009-0093 (6th Cir. Mar. 28, 2013), the National Truck Equipment Association (NTEA) challenged the legality of an increase in the weight limit of vehicles subject to roof crush resistance strength requirements under Federal Motor Vehicle Safety Standard (FMVSS) No. 216a, as applied to certain classes of vehicle manufacturers. NTEA's petition claimed that FMVSS No. 216a should not apply to "final-stage manufacturers" and "alterers" because, by expanding roof crush resistance requirements to these manufacturers, NHTSA acted in an arbitrary and capricious manner, contrary to the National Traffic and Motor Vehicle Safety Act of 1966, and improperly delegated ... 23e26da5-5925-4249-b3cb-58e25d9b9d8d Thu, 28 Mar 2013 16:23:59 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/EPA-Announces-New-List-of-Chemicals-Targeted-for-Risk-Assessment-Under-TSCA-Including-20-Flame-Retardants On March 27, 2013, EPA announced its new "hit list" of chemicals that will undergo full risk assessment and analysis in the coming year as part of the Toxic Substances Control Act (TSCA) Work Plan. Prominent on the list are 20 flame retardants that are widely used in furniture, textiles, electronic equipment, and other household products.  This list represents EPA's second round of risk assessments, and is viewed as one of the agency's primary tools for regulating chemicals under its current TSCA authority while statutory reform efforts languish in Congress. EPA will subject four of the flame retardants to a full risk assessment: 2-Ethylhexyl ester 2,3,4,5- tetrabromobenzoate (TBB) 1,2- Ethylhexyl 3,4,5,6-tetrabromo-benzenedicarboxylate, or (2-ethylhexyl)-3,4,5,6 tetrabromophthalate (TBPH) Tris(2-chloroethyl) phosphate (TCEP) Hexabromocyclododecane (HBCD) ... 3468dc7d-b7a8-495b-9544-7c20cbf07797 Thu, 28 Mar 2013 17:52:22 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Supreme-Court-Raises-the-Bar-for-Class-Action-Suits-by-Requiring-Plaintiffs-to-Show-a-Specific-Calculation-of-Damages-for-the-Specific-Theory-of-Harm-for-which-a-Class-is-Certified On March 27, 2013, in Comcast Corp. v. Behrend, the Supreme Court ruled in a 5-4 decision that a class cannot be certified under Rule 23(b)(3) unless plaintiffs prove that they can calculate damages on a classwide basis, and that the proposed damages methodology isolates damages to the specific theory of harm for which the class is certified. Building on its decision in Wal-Mart v. Dukes, the Court confirmed that the analytical principles it articulated for determining whether the Rule 23(a) factors are satisfied apply equally—if not more so—to Rule 23(b), particularly because Rule 23(b)(3)'s predominance prong is more demanding. In finding that the district court had improperly certified the class, the Court reaffirmed that a court cannot sidestep the mandated rigorous analysis required for class certification under Rule 23 simply because the inquiry would also be relevant to the merits determination.   In Comcast—a case that involved antitrust allegations ... b4d1768e-0a12-4ee2-b13d-5da4fa2a9f83 Thu, 28 Mar 2013 13:06:38 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/European-TMT-Privacy-Bulletin-March-2013 Sections of this issue: ISP Liability and Media Law "New public" and "New Technical Means" – Cumulative Criteria? Electronic Communications & IT ICANN Publishes Target Date For the Delegation of the First New gTLD New Tool to Combat Cybersquatting Ready For Implementation Companies May Begin to Protect Their Online Presence Anew: Trademark Clearinghouse for New gTLDs Launched on 26 March 2013 Privacy & Data Protection Apps on Smart Devices and Data Protection: February 27, 2013 Opinion of the Article 29 Working Party Provides Valuable Guidance Contracts & E-Commerce Belgian Regulator Fines Telecom Operators For Breach ... 20da664b-c8d6-4c16-8538-7d018e70ef12 Thu, 28 Mar 2013 14:42:17 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Virginia-Becomes-First-State-to-Limit-Substitution-of-Biosimilar-Drugs This week Virginia became the first state in the nation to enact a law that limits the substitution of biosimilar drugs. On March 26, 2013, Virginia's Governor signed into law (SB 1285/HB 1422), codified as §54.1-3408.04, entitled Dispensing of interchangeable biosimilars permitted. By its terms, the law forbids pharmacists from dispensing a biosimilar substitution to a brand-name biologic drug if the prescribing physician specifies the prescription must be dispensed as written or if a patient wants the branded drug. Other extra administrative requirements for dispensing a biosimilar require pharmacists to inform patients before dispensing a biosimilar and require them to note the product name and manufacturer on the prescription label and dispensing record. Pharmacists also must give patients cost information on the branded and biosimilar products under the law, which as enacted will automatically expire in July, 2015.  Unlike traditional 'small molecule' pharmaceuticals, biologic drugs are made from living materials ... 8173eb08-bbc7-495e-8bea-782324ebba4f Tue, 26 Mar 2013 12:20:07 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Third-Circuit-Upholds-Reduced-Pleading-Requirements-for-SOX-Whistleblowers It just got easier for alleged whistleblowers under the Sarbanes-Oxley Act (SOX) to avoid dismissal of their claims. At least in the Third Circuit, putative whistleblowers only need to allege that they informed management of their reasonable belief that the employer's practices constitute fraud in violation of at least one of SOX Section 806's enumerated statutes or regulations to sufficiently plead they engaged in protected activity. In Weist v. Lynch, No. 11-cv-4257, 2013 WL 1111784 (3d Cir. Mar. 19, 2013), the Third Circuit became the first appellate court to address and adopt the recent decision by the U.S. Department of Labor's Administrative Review Board (ARB) in Sylvester v. Parexel Int'l, ARB 07-123, 2011 WL 2165854 (Dep't of Labor May 25, 2011) (en banc),that specifically relaxed the pleading requirements for alleged SOX whistleblowers. This appellate adoption of the more lenient Sylvester standard likely means that more SOX whistleblower claims are on ... a7386903-ca94-40c7-96ee-faf0c8bfcbf6 Tue, 09 Apr 2013 13:17:17 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Egypts-Shura-Council-Approves-Law-Providing-for-Regulation-of-Sukuk-Islamic-Bonds The new law, riding on the back of Arab Spring-fueled anticipation of a resurgence of Islamic finance in the MENA region, opens the door for all forms of sukuk issuances, including sukuk to finance debt, assets, projects, businesses, and investments. The wide-reaching law allows for both corporate and sovereign sukuk and asset-backed as well as asset-based sukuk structures- issuances may be in foreign currency or Egyptian pounds. A provision is included for setting up a central government Shariah entity to monitor compliance, the members of which will be appointed by the Prime Minister. The new law allows for arbitration to regulate its application, and includes restrictions regarding the use of publicly held state-owned assets, if classified as public domain.  The law is expected to decrease the financial burden on the government by helping it finance the reform and infrastructure projects that Egypt badly needs. Funding derived ... a73b108f-562c-42ed-a73f-e7742332708d Tue, 26 Mar 2013 16:23:01 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/State-Government-Coalition-Issues-Draft-Guidance-For-Assessing-Alternatives-to-Chemicals-Of-Concern On March 18, 2013, an association of state, local, and tribal governments released draft guidance for companies and regulators to use in analyzing potential alternatives for "chemicals of concern" found in products. With agency involvement from eleven states, this guidance document may become the framework for significant state action regarding the regulation and mandating of alternatives assessments at the state level. It may also be used as a tool by advocacy groups and others to bolster marketplace "de-selection" efforts. Public comments on this draft guidance are due April 19, 2013. This guidance document, Guidance for Alternatives Assessment and Risk Reduction ("AA Guidance") was released by an eleven state consortium known as the Interstate Chemical Clearinghouse (IC2). The consortium, which includes member agencies from California, Connecticut, Maine, Massachusetts, Michigan, Minnesota, New York, Oregon, Vermont, and Washington, received substantial financial and technical support from the U.S. Environmental Protection Agency and EPA's ... bf48fb90-35b4-4ed2-bec0-641bcbb393dc Tue, 26 Mar 2013 20:15:54 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Companies-May-Begin-to-Protect-Their-Online-Presence-Anew-Trademark-Clearinghouse-Now-Available-For-New-gTLDs As of March 26, 2013, trademark owners may submit their trademarks for inclusion in the "Trademark Clearinghouse," which may be a valuable tool for minimizing the potential for abuse resulting from the imminent expansion in the number of generic Top Level Domains (gTLDs). Inclusion in the Clearinghouse will give the mark owner the opportunity to register the mark in each new gTLD before the general public and will provide other notice benefits as well. The Internet Corporation for Assigned Names and Numbers (ICANN) is involved in a process that will greatly expand the number of gTLDs. Currently there are around twenty active gTLDs, of which ".com" is the best known. Soon new gTLDs will be implemented and hundreds more may follow. To address some of the concerns regarding the correspondingly expanded potential for trademark abuse, ICANN has authorized the establishment of a Trademark Clearinghouse to allow trademark owners to submit their trademarks ... b552473a-c233-47ed-821e-d7611653190b Mon, 25 Mar 2013 14:49:57 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/UCC-Termination-Statements-Require-Authorization-To-Be-Effective On March 1, 2013, the U.S. Bankruptcy Court for the Southern District of New York held that the termination of a Uniform Commercial Code ("UCC") Article 9 initial financing statement where such termination is filed by a third party "agent" of the borrower is ineffective to terminate a secured party's perfected status absent specific authorization by the secured party1. While this decision does not represent groundbreaking new Article 9 law, it does underscore yet again the importance of attention to detail and due diligence when addressing Article 9 financing statement matters. Background A secured party (the "Secured Party") acted as administrative agent for two wholly-unrelated financing facilities with the same borrower (the "Borrower"). In 2001, the Borrower entered into a $300 million synthetic lease transaction (the "Synthetic Lease") with the Secured Party serving as one of the backup facility banks and the administrative agent. In connection with the Synthetic ... 7fa05946-7d1f-4efe-a136-89f41dd59a1e Mon, 25 Mar 2013 17:13:11 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/SEC-Issues-Much-Needed-Guidance-on-Rule-15a-6-Regarding-Foreign-Broker-Dealers The Securities and Exchange Commission ("SEC") issued guidance in the form of FAQs on March 21, 2013 that clarify certain issues that have arisen under Rule 15a-6 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") ("Rule 15a-6"). Rule 15a-6 provides guidance to foreign broker-dealers ("FBDs") regarding U.S. broker-dealer registration requirements related to FBDs' conduct of business in the United States or with U.S. citizens and residents. Adopted in 1989 and later amplified by two SEC No Action Letters known as the Seven Firms Letter (which expanded the definition of major institutional investor to include unregistered investment advisors with over $100 million under management) and the Nine Firms Letter (which allows expanded contacts and certain unchaperoned activities) (collectively, the "Rule"), the Rule permits FBDs to conduct business in the U.S. without registering as U.S. broker-dealers provided certain conditions are met. The general circumstances under which U.S. registration ... 8f76093b-0e19-4a57-9ddc-0a3596f68a5f Fri, 22 Mar 2013 15:08:14 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Seventh-Circuit-Applies-Offsets-to-FCA-Damages-Before-Trebling In U.S. v. Anchor Mortgage Corp. (7th Cir. Mar. 21, 2013), Chief Judge Easterbrook held that, in calculating the damages to be trebled under the FCA, courts must use a "contract measure of loss" approach that would take into account any offsets for value or payments received by the government prior to trebling. The court read the Supreme Court's decision in U.S. v. Bornstein to require third-party payments to be subtracted after multiplying the damages only when such payments are not part of a "contract measure of loss" calculation, a limitation that could significantly reduce FCA damages in many contexts. 6fc8c70a-10db-4273-924a-cc3931fc1b70 Fri, 22 Mar 2013 16:29:50 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Supreme-Court-Rejects-Attempt-by-Class-Action-Plaintiff-to-Plead-Around-Federal-Court-Jurisdiction On March 19, 2013, the Supreme Court held unanimously that federal jurisdiction under the Class Action Fairness Act (CAFA) cannot be defeated by a named plaintiff's stipulation, prior to class certification, that he will not seek damages above $5 million on behalf of the class. The decision resolves a conflict among the federal courts of appeal, and reinforces CAFA's goal of ensuring that large interstate class actions are heard in federal court. In Standard Fire Insurance Company v. Knowles, plaintiff Greg Knowles filed a putative class action in Arkansas state court against Standard Fire Insurance Co. on behalf of "hundreds, possibly thousands" of insureds. Standard Fire removed the action to federal court under CAFA, which provides federal district courts with "original jurisdiction" to hear class actions if the class has more than 100 members, the parties are minimally diverse, and the amount in controversy exceeds $5 million in the ... 5bf17a9e-478b-49bc-aa60-8cfa6577b5ac Fri, 22 Mar 2013 11:24:48 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Good-News-for-Goldman-Second-Circuit-Requires-Individual-Arbitration-of-Title-VII-Claim The Second Circuit ruled yesterday in Parisi v. Goldman Sachs & Co. (Second Cir. No. 11-5229-cv, March 21, 2013) that the employer can compel a female former managing director to go to individual arbitration on her claim of systemic gender discrimination. Parisi is one of several closely-watched cases pending in the Second Circuit that address the issue of whether employers can enforce mandatory arbitration agreements.  Yesterday's opinion reversed a trial court decision concluding that the plaintiff could proceed with her claim as a class action in federal court, reasoning that individual arbitration would effectively deny her substantive right under Title VII to bring a pattern-or-practice claim against Goldman.        Parisi and two other female former employees brought a class action complaint against Goldman Sachs, alleging that the firm engaged in a "continuing pattern and practice" of gender discrimination against managing directors and other executives in violation of Title VII, ... 3c6d7c19-80a8-4117-b4bf-819e49f653ed Thu, 21 Mar 2013 17:38:05 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Massachusetts-Court-Broadly-Interprets-Personal-Identification-Information-to-Include-Zip-Codes-Holds-Identity-Theft-Unnecessary-to-Sustain-Private-Cause-of-Action A Massachusetts federal court ("federal court") certified several privacy related questions of first impression to the Massachusetts State Supreme Judicial Court ("State court") to clarify the scope of state law. In response, the State court broadly construed "personal identification information" ("PII") and held that collecting customer zip codes during credit card transactions violates Massachusetts privacy laws (G.L. c. 93 § 105(a)). The State court also held that plaintiffs can maintain a private action for such a violation even absent any claim of resulting identity theft.  This decision has significant implications for any national or local retailer that conducts business in Massachusetts. The case is Tyler v. Michaels Stores, Inc., --- N.E. 2d ---, 2013 WL 854097 (Mass. Mar. 11, 2013). In the underlying federal case, a putative class alleged that Michaels Stores ("Michaels") records customers' zip codes when processing credit card transactions—even though credit card issuers do not require this information. ... a54179fa-1269-4ab0-a37b-da2991524266 Wed, 20 Mar 2013 12:14:31 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Wartime-Suspension-of-Limitations-Act-Available-to-Qui-Tam-Relators-Even-When-the-US-Does-Not-Intervene In U.S. ex rel. Carter v. Halliburton Co. (Mar. 18, 2013), the Fourth Circuit held that (1) dismissals of a qui tam plaintiff's FCA complaint under the first-to-file bar should be without prejudice, thereby allowing a relator to refile her complaint after the original action has been dismissed and is no longer "pending"; and (2) the Wartime Suspension of Limitations Act (WSLA), which tolls "any statute of limitations applicable to any offense[ ] involving fraud or attempted fraud against the United States" "[w]hen the United States is at war," applies (i) to both civil and criminal fraud against the United States, (ii) even without a formal declaration of war, and (iii) regardless of whether the U.S. intervenes. In a partial dissent, Judge Agee argued that allowing relators to benefit from the WSLA when the government has not intervened provides a "strong financial incentive for relators to allow false claims to ... ef2a3363-b8d6-48ad-b91e-db8064751108 Mon, 18 Mar 2013 12:03:13 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/SEC-Investment-Management-Division-Issues-Guidance-Concerning-Social-Media-and-Filing-Requirements-for-Mutual-Funds Last week, the SEC's Investment Management Division released its first guidance update of the year. The topic addressed by staff: whether certain interactive content posted on social media should be filed publicly by a mutual fund. The "rule" issued by the staff is as follows: "Whether a communication need be filed depends on the content, context, and presentation of the particular communication or set of communications and requires an examination of the underlying substantive information transmitted to the social media user and communication of any other facts and circumstances, such as whether the interactive communication is merely a response to a request or inquiry from the social media user or is forwarding previously-filed content." The staff provided examples of communications that should be filed (fund performance and investment merits of a fund) and those that need not be filed (incidental mentions of funds and discrete factual information, for ... b9ab5d1c-b125-43b2-beb2-927474bf6731 Fri, 15 Mar 2013 14:48:57 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Allegation-of-Data-Breach-Alone-Insufficient-to-Sustain-Claims-Based-on-Inadequate-Cybersecurity On March 6, 2013, the United States District Court for the Northern District of California held that a putative class of LinkedIn premium users lacked standing to pursue state law unfair competition, breach of contract, and negligence claims resulting from a hacking incident. The court dismissed the complaint, concluding that the plaintiffs failed to establish any legally cognizable injury and any causation between the alleged incident and any alleged economic harm. LinkedIn, the online community for professional networking, offers both free and premium paid accounts to consumers. The Privacy Policy applicable to both types of accounts provides that user information will be protected with "industry standard protocols and technology," but notes that it provides no guarantee that LinkedIn's security will be able to prevent all security breaches. On June 6, 2012, hackers infiltrated LinkedIn's computer systems and posted 6.5 million user passwords and email addresses. LinkedIn subsequently updated its password encryption method to ... 369d6638-a6fd-4d5f-9bea-957942485aa5 Thu, 21 Mar 2013 12:41:32 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/DOL-Issues-Guidance-on-Additional-Annual-Funding-Notice-Disclosures-for-Single-Employer-Defined-Benefit-Plans On March 8, the Department of Labor ("DOL") issued a field assistance bulletin ("FAB 2013-01") to assist administrators of single-employer defined benefit plans in preparing plans' annual funding notices ("AFNs"). Specifically, many plans using the stabilized interest rates under the Moving Ahead for Progress in the 21st Century Act ("MAP-21") will have to disclose the effect of MAP-21 on the funding of the plan. FAB 2013-01 provides guidance regarding this new disclosure requirement. Background Single-employer defined benefit pension plans are subject to certain minimum funding requirements under Section 430 of the Internal Revenue Code ("Code") and Section 303 of the Employee Retirement Income Security Act of 1974, as amended ("ERISA"). Code Section 430 and ERISA Section 303 also specify the interest rates generally used to determine the present value of a plan's liabilities. Currently, those interest rates are the segment rates described in Section 303(h)(2)(C) of ERISA. MAP-21 amended ERISA to allow plans ... 3bde527a-b496-4615-bc7d-87b19ff45346 Tue, 26 Mar 2013 20:11:57 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Objection-Period-for-New-gTLD-Applications-Closes-Today-Affected-Applicants-Will-Have-Approximately-60-Days-to-Respond The period for filing an objection to a new gTLD application, which opened in June 2013, closes today. During the objection period, objections could be filed on the basis of string confusion, limited public interest, community opposition, and legal rights. With the objection period now closing, the Dispute Resolution Service Providers (DSRPs) will now proceed with the resolution of the objections. The first step is the DRSPs' administrative reviews of each objection, during which objectors will be given an opportunity to correct any administrative deficiencies that would otherwise disqualify their objections. Properly filed objections will then be registered for processing, at which time information about the objections must be posted to the DRSPs websites. Information about the objections will therefore become publicly available in a piecemeal fashion over the next few weeks, and ICANN's formal Dispute Announcement identifying all registered objections will be posted within 30 days. Following this ... bac30073-dd53-44ff-93c6-44cb70d0d310 Wed, 13 Mar 2013 12:26:38 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/EU-Regulatory-Update-Deadlines-Loom-Under-the-EU-REACH-Legislation The EU REACH legislation establishes an integrated system for the registration, evaluation, authorization and restriction of chemical substances. It requires all companies (including US-based companies) which manufacture in, or import chemical substances into, the EU in quantities of one ton or more per year to register them with the European Chemicals Agency in Helsinki, Finland. Companies which have pre-registered "phase-in" substances (which include those listed in the European Inventory of Existing Commercial Chemical Substances) benefit from extended registration deadlines. A May 31, 2013 deadline for registration applies to substances produced or imported into the EU in volumes of between 100 and 1000 tons per year per manufacturer or importer. The REACH legislation requires that the EU member states introduce penalties for non-compliance with its provisions. For example, in the UK, national enforcement provisions provide maximum penalties of an unlimited fine and/or up to two years' imprisonment following ... 1a965f6e-dd15-47c9-bdea-507fa949d1c6 Tue, 12 Mar 2013 11:07:18 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/All-Businesses-in-Saudi-Arabia-Now-Obliged-to-Employ-Saudi-Nationals The Saudi Arabian Ministry of Labor's Nitaqat program obliges businesses in Saudi Arabia to ensure that a certain percentage of their workforce is comprised of Saudi nationals (the Saudization Obligation) and ranks businesses on the basis of the businesses' compliance with the Saudization Obligation. Under the Nitaqat program, the specific percentage (or range of percentages) of a business’s workforce that must be comprised of Saudi nationals is determined by reference to (a) the business activity that the business undertakes and (b) the total size of the business’s workforce. Since the implementation of the Nitaqat program in 2011, businesses with fewer than 10 employees have been exempt from the application of the Nitaqat program, so that businesses with fewer than 10 employees could in principle have no Saudi employees at all. However, this exemption will expire as of 30 March 2013, at which time every business in Saudi Arabia ... acd9e1e8-5c92-4f04-9ae1-aaf1733cd12e Fri, 15 Mar 2013 15:24:38 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/SEC-Sends-Message-to-Stop-Fundraising-by-Unregistered-Finders-comes-Down-Hard-on-Fund-Sponsor-and-Managing-Partner An SEC settlement announced yesterday sounds a loud message to "finders" and those who use their services. Ranieri Partners LLC, a manager of a number of real estate investment funds, used the services of William Stephens, a person barred from association with any investment advisor, to locate investors for its funds. Stephens and his agent solicited $569 million in capital contributions for various Ranieri funds. Although Stephens was not permitted to send out offering materials, Ranieri Partners did not limit his access to such materials. The then Senior Managing Partner of Ranieri, Donald Phillips, provided Stephens with private placement memoranda, subscription documents and due diligence materials, which Stephens transmitted to potential investors and spoke with those persons about the funds. Ranieri Partners and Phillips thus aided and abetted Stephens' illegal conduct.  Although the Securities Exchange Act of 1934 (the "Exchange Act") requires persons engaged in the business of effecting transactions in ... f3a4cb7e-5eba-4601-9e43-ac5f7c67149e Mon, 11 Mar 2013 12:08:38 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Fierce-in-February-FTC-Mobile-Privacy-Making-the-Most-of-the-Shortest-Month Although it is March that traditionally "comes in like a lion," the Federal Trade Commission has roared through February—especially when it comes to the issue of consumer privacy in the mobile arena. The month started off with a one-two punch: First, on February 1, the FTC released its staff report on mobile privacy titled, "Mobile Privacy Disclosures: Building Trust Through Transparency," which focuses on the need for "just-in-time" disclosures and the benefits of "Do Not Track" software, consumer education, short-form disclosures, and standardized privacy policies on mobile devices. Second, on that same day, the Commission also announced a settlement with Path Social Networking App, a mobile app which, the FTC charged, deceived users by collecting personal information from mobile devices without users' knowledge and consent. The settlement included a requirement that Path establish a comprehensive privacy program, obtain independent privacy assessments every other year until 2033, and pay ... a4976f1c-f154-4e1b-9489-efe04cc4a9b5 Mon, 11 Mar 2013 12:35:36 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/New-OFCCP-Compensation-Guidance-Offers-Little-to-Guide-Contractors As expected, the U.S. Department of Labor, Office of Federal Contract Compliance Programs ("OFCCP" or "Agency") has rescinded two compensation discrimination enforcement devices promulgated in 2006 – the only previously-existing guidance regarding the Agency's approach to compensation discrimination. In their place, the OFCCP has issued Directive 307 – Procedures for Reviewing Contractor Compensation Systems and Practices, which adopts a "case-by-case" approach and gives the Agency maximum flexibility to simply do as it sees fit when analyzing compensation data submitted by covered federal contractors and subcontractors ("Contractors").  The Rescission Notice criticizes the prior Bush-era guidance as a "rarely used, ineffective and burdensome compliance procedure." The Notice expressly rejects certain provisions of the 2006 guidance, including the prior regulatory requirement that the Agency would not pursue statistical disparities without accompanying anecdotal evidence of pay discrimination. To justify this change, the OFCCP stated that it will not ignore possible indications of discrimination ... 46cbd059-0c53-4c3b-aafa-79a1ce5d6dee Mon, 11 Mar 2013 13:23:12 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/ICANN-Publishes-the-URS-Rules-and-an-Updated-Version-of-the-URS-Procedure Background The Uniform Rapid Suspension system (URS) is a rights protection mechanism developed by ICANN to be implemented within new gTLDs that facilitates "rapid" suspension of domain names in clear-cut cases of trademark infringement. As ICANN has described the URS, It is intended to complement the existing Uniform Domain Name Dispute Resolution Policy (UDRP) by offering a faster path to resolution for mark holders at a lower-cost. For the time being, the National Arbitration Forum (NAF) is the only URS service provider appointed by ICANN. In time, ICANN may establish additional providers. ICANN's latest communication on the subject On March 5, 2013, ICANN published a new version of the URS Procedure, a policy document updating the draft version of the policy that was posted in ICANN's June 2012 Applicant Guidebook. ICANN also published a set of Rules for the URS Procedure, similar to the UDRP rules. ... 16aac521-8bfe-457d-a0da-ebcf9ac51ddc Fri, 08 Mar 2013 11:41:41 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/CMS-Publishes-Physician-Payment-Sunshine-Rule The Centers for Medicare & Medicaid (CMS) recently published a long-awaited final regulation concerning payments to physicians from drug, device and supply manufacturers, as contemplated by section 6002 of the Affordable Care Act (ACA). Known as the physician payment "sunshine" rule, the new regulations require certain drug, device and supply manufacturers to report payments—direct and indirect—and other transfers of value provided either to physicians or teaching hospitals. 42 C.F.R. § 403.904.  Though the sunshine rule gets its nickname from payments to physicians, the rule also requires manufacturers and group purchasing organizations (GPOs) to report ownership and investment interests in the manufacturers or the GPOs which are held by physicians or immediate family members of physicians. 42 C.F.R. § 403.906.  On a general level, the obligations set forth by the final rule mirror the obligations set forth by section 6002 of the ACA, but the final rule provides many more ... b6f5a4ac-d577-488b-a75a-bb5ac53699f4 Fri, 08 Mar 2013 12:02:34 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/GSA-CO-Must-Decide-GSA-Schedule-Contract-Disputes In Sharp Electronics Corp. v. McHugh (Feb. 22, 2013), the Federal Circuit affirmed the dismissal of a GSA Schedule contractor's appeal for lack of jurisdiction because it had presented its claim to the ordering agency CO rather than the GSA Schedule CO. Because the dispute involved certain premature discontinuance fees provided for in the underlying Schedule contract and did not involve a performance-related dispute, the court held that the GSA CO was the one authorized by FAR 8.406-6 to decide the claim. eaa532a9-fe62-4dab-8d4d-a7f822000ab8 Fri, 08 Mar 2013 12:36:08 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/OPM-Issues-Notice-of-Written-Suspension-and-Debarment-Policy On February 21, 2013, the Office of Personnel Management (OPM) issued a notice in the Federal Register of its intent to adopt the policies and procedures set forth in the Federal Acquisition Regulation (FAR) at Subpart 9.4 concerning debarment, suspension, and ineligibility of government contractors. Because OPM's procurement rules are not contained in the Code of Federal Regulations, OPM proposes a new internal policy, to be titled "Contracting Policy 9.4: OPM Suspension and Debarment Program." OPM states that it has long-maintained procedures consistent with FAR Subpart 9.4, but it is adopting this proposed policy to make clear that FAR Subpart 9.4 applies to its contracting decisions.  Consistent with FAR Subpart 9.4, the proposed policy will provide as follows: OPM will not solicit offers from, award contracts to, or consent to subcontracts with contractors who are listed on the Excluded Parties List ... 9d44b203-41aa-4095-a857-0bd9638a2662 Fri, 08 Mar 2013 11:05:43 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/SEC-Issues-Risk-Alert-Regarding-Adviser-Examinations The SEC's Office of Compliance Inspections and Examinations issued a Risk Alert (the "Risk Alert") on March 4, 2013 highlighting the SEC's ongoing concern with "significant deficiencies" in registered investment advisers' compliance with the so-called Custody Rule, Rule 206(4)-2 of the Investment Advisers Act of 1940. In particular, the SEC noted that it had found custody-related issues in approximately one-third of recent investment adviser examinations in which significant deficiencies had been found.  The SEC's heightened concern with custody-related issues is a continuation of its post-Bernand Madoff focus on registered investment advisers. The Ponzi scheme perpetrated by Madoff was in part possible because Madoff had custody of client assets and there were no safeguards in place to prevent his misappropriation. Following the revelation of the Madoff debacle, the SEC adopted amendments to the Custody Rule that were designed to better protect investor assets. Those rule modifications require advisers to submit to ... 42858cf0-5e93-436d-a002-0b6fd3ca1160 Fri, 08 Mar 2013 09:25:32 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/New-gTLD-Applicants-Submit-Public-Interest-Commitments-for-499-Applications-in-Response-to-ICANNs-Invitation Background On February 5, 2012, ICANN invited new gTLD applicants to submit "Public Interest Commitments" (PICs) that would later be incorporated in their Registry Agreement as binding obligations, to be enforced through a new PIC Dispute Resolution Process. Applicants were invited to submit both PICs that incorporated either specific commitments from their application and PICs that identified additional commitments the applicant intends to fulfill. The PICs mechanism is ICANN's response to the Governmental Advisory Committee's (GAC) direction in the Toronto Communiqué that the ICANN board find a mechanism to ensure that commitments made in applications were transformed into "binding contractual arrangements, subject to compliance and oversight." Additionally, ICANN invited applicants to use PICs to address specific concerns that the GAC or individual countries have raised about their applications. Additionally, all applicants will be required to agree to a PIC requiring the use of only registrars that agree ... f38f3ed2-011a-4e7f-b3fb-f8569e785c22 Wed, 06 Mar 2013 10:38:00 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Sequestration-New-Agency-Letters-Warn-Industry Federal agencies, including DoD and DHS, began issuing letters to industry this week warning that the effects of sequestration, imposed on March 1, may be felt on existing and planned procurements, may affect agencies' ability to administer contracts efficiently, and in the words of DHS, may result in "existing contracts being reduced in scope, terminated or partially terminated." While asking for industry's cooperation in this time of "enormous budgetary uncertainty" and stating that decisions with respect to specific contracts will be communicated directly by the responsible contracting officials, DoD advised that "damage to the Department and to industry is unfortunately unavoidable at this point." 6830f4d3-515c-4a1d-98a2-b38fd09e22a5 Tue, 05 Mar 2013 10:25:42 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Big-Brown-Citizen-Suit-Survives-Motion-to-Dismiss A federal district court in Texas has allowed the Sierra Club's Clean Air Act citizen suit against the Big Brown Plant in Freestone County, Texas to proceed past a multifaceted motion to dismiss. As part of its Beyond Coal Texas campaign, the Sierra Club seeks to force the largest power providers in Texas to phase out operations at the Big Brown Plant by alleging that the plant routinely exceeds the opacity limit established in Texas's State Implementation Plan (SIP) and the plant's Title V operating permit (even assuming that the plant has utilized its hourly six-minute exemption) as well as the particulate matter (PM) limit set forth in the Texas SIP.  In Sierra Club v. Energy Future Holdings Corporation, No. 6:12-CV-108, -- F. Supp. 2d --, 2013 WL 485363 (W.D. Tex. Feb. 6, 2013), the court denied the owner and operator's motion to dismiss, rejecting all of the commonly ... 9c230bf1-e843-4828-affd-2045dfd781f0 Tue, 05 Mar 2013 15:45:27 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/California-Employees-Entitlement-to-Leave-for-Pregnancy-Disability-not-Limited-to-Four-Months Under California's Pregnancy Disability Leave Law (PDLL), employers must provide up to four months of paid or unpaid leave because of an employee's actual disability based on pregnancy. Some employers have been of the view that their obligation to provide leave for pregnancy disability ends at the end of those four months. Not so, said the California Court of Appeal recently in a case of first impression. In Sanchez v. Swissport, Inc., B237761 (Cal. Ct. App. 2d App. Dist., February 21, 2013), the Court of Appeal held that California's Fair Employment and Housing Act (FEHA) obligates employers to consider requests for accommodation, including extended leaves of absence, after the four months of pregnancy disability leave (PDL) is exhausted. After she was diagnosed with a high-risk pregnancy requiring bed rest, Ana Sanchez requested a temporary leave of absence, which request her employer granted. She expected to be disabled and unable to work ... 6a6d63ca-da7c-4d2b-b807-207b94afb72f Tue, 05 Mar 2013 15:19:26 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Highlights-from-ICPHSO-2013 The International Consumer Product Health and Safety Organization (ICPHSO) hosted its 20th annual meeting and training symposium on February 26-March 1, 2013, just outside of Washington, D.C. Crowell & Moring attorneys Bridget Calhoun and Lynn Levitan were speakers and attended this year's meeting along with attorneys Cheryl Falvey, Natalia Medley, Laura Walther, and Monica Welt. Conference Overview. Once again, a highlight of this year's meeting was "CPSC Day," where representatives from the U.S. Consumer Product Safety Commission (CPSC) spoke about the Commission's positions on key issues and priorities for the coming year. Speakers included CPSC Chairman Inez Tenenbaum, Commissioner Robert Adler, new General Counsel Stephanie Tsacoumis, Executive Director Kenneth Hinson, Office of Import Surveillance Director Carol Cave, Acting Director of Compliance and Field Operations Marc Schoem, among many others. Other attendees and speakers at the four-day meeting included representatives from other federal agencies, including the Food and Drug Administration (FDA), Consumer and ... 1758339c-4fa2-42ba-aec4-2fc980ca1167 Mon, 04 Mar 2013 15:44:38 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/New-Legislation-Seeks-to-Shift-Legal-Fees-to-Unsuccessful-Nonpracticing-Entities Last month, President Obama advocated for stricter legislation to limit frivolous lawsuits filed by nonpracticing entities (derisively called "patent trolls"). Last week, Rep. Peter DeFazio, D-Ore., and Rep. Jason Chaffetz, R-Utah, introduced the Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013 (the "SHIELD Act") in committee. The bill provides that a party adverse to a patent holder may move the judge for a finding that the patent holder is a "nonpracticing entity." If the judge finds that the patent holder is a nonpracticing entity, the patent holder must post a bond sufficient to cover a reasonable measure of the attorney fees and costs of the adverse party to defend the case. If the court later enters final judgment against the patent holder, the bill requires that the court award recovery of actual attorneys fees and costs to the adverse party. Only in "exceptional circumstances" may a court decline ... 47f15b48-4d62-43cc-9285-f56967c86ef6 Mon, 04 Mar 2013 14:50:10 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Relators-Detailed-Allegations-Cannot-Overcome-Public-Disclosure-Bar In U.S. ex rel. Mateski v. Raytheon Co. (C.D. Cal. Feb. 26, 2013), the district court dismissed the qui tam relator's action under the pre-2010 "public disclosure" provision, holding that, although the relator's allegations were much more specific than the information which had been publicly disclosed in the media, congressional hearings, and administrative reports, the broadly worded public disclosures on the same topics were sufficient to supply the government with enough information to initiate an investigation and, therefore, barred the action. The court rejected the relator's novel suggestion that it apply a Rule 9(b) particularity requirement to the publicly disclosed information, and it rejected his contention that he was an original source because (a) he had no hand in the public disclosure (a requirement which not all circuits apply), (b) he failed to provide his information to the government before filing suit, and (c) he could not demonstrate that he ... f94687a9-4295-4618-9aee-41b738d13073 Thu, 07 Mar 2013 14:55:18 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/ICANNs-Selected-Providers-Publish-Guidelines-for-Using-the-Trademark-Clearinghouse Background ICANN has foreseen mandatory rights protection mechanisms (RPMs) for New gTLDs aimed at limiting abusive domain name registrations. These include the use of the Trademark Clearinghouse (TMCH), aimed at providing trademark holders with more extensive and cost-effective opportunities to protect and safeguard their trademarks in New gTLDs. The TMCH is expected to be active as from 26 March 2013. It will be a central repository of trademark related data which is used in order to technically support and streamline some of the mandatory RPMs for New gTLDs. Trademarks will need to be validated by the TMCH for trademark holders to participate in Sunrise Phases of New gTLDs or to benefit from the so-called Trademark Claims service. A Sunrise Phase is a period before domain names become available to all eligible registrants during which trademark holders (who meet the eligibility requirements) must be given the opportunity to ... 498ebc8d-a0a3-4a40-b926-caa760616fa9 Mon, 04 Mar 2013 17:42:48 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Chief-Counsel-Memo-Reveals-IRS-Seeks-to-Build-on-its-Recent-Victories-in-Partnership-Cases The IRS Chief Counsel's Office released a Field Counsel memorandum rejecting the use of a partnership to allow new investors to access historic rehabilitation tax credits that otherwise would have gone unused. The memorandum argued that the partnership lacked economic substance and was a sham partnership because the new partner had no meaningful stake in the partnership when it came to either risk or reward. This memorandum, which follows the Third Circuit's decision rejecting a rehabilitation tax credit structure in Historic Boardwalk Hall, LLC v. Commissioner, 694 F.3d 425 (3rd Cir. 2012), demonstrates that the IRS continues to scrutinize partnership structures designed to allocate tax credits to partners that the IRS views as taking on little of the risk associated with the activities generating the credits. Moreover the IRS's technical arguments build on the IRS's victories in TIFD III-E, Inc. v. United States, 459 F.3d 200 (2nd Cir. 2006) ("Castle Harbour"), VA Historic ... 288395d2-4946-4366-a1fa-69bd8e6b3251 Fri, 01 Mar 2013 10:45:26 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Supreme-Court-Rejects-SECs-Ability-to-Seek-Civil-Penalties-More-than-Five-Years-after-an-Alleged-Fraud Earlier this week, the U.S. Supreme Court unanimously rejected the Securities and Exchange Commission's argument that the five-year statute of limitations period in 28 U.S.C. § 2462—the default limitations provision that governs civil penalties—begins to run when the fraud is discovered, not when the underlying violation occurred. Gabelli v. Securities and Exchange Commission (Feb. 27, 2013). The Court held that the discovery rule, which tolls the statute of limitations when a defendant's fraud prevents the plaintiff from realizing the injury, does not apply to government enforcement actions for civil penalties. In Gabelli, the SEC filed fraud charges against individual defendants based on allegations of market timing. Although the SEC alleged violations from 1999 through August 2002, it did not file its complaint until April 2008, well after the five-year statute of limitations had lapsed. In an opinion by Chief Justice Roberts, the Court soundly rejected the SEC's request to apply the discovery ... 40a9abfb-3cec-49cc-928a-6b4a0e0b45da Thu, 28 Feb 2013 15:38:23 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/This-Month-in-International-Trade-February-2013 THIS MONTH'S TOP FIVE DEVELOPMENTS 1) EU and U.S. Launch Transatlantic Trade and Investment Partnership Negotiations President Obama confirmed in his February 14 State of the Union address that the EU and the U.S. are set to launch negotiations for a comprehensive trade and investment partnership agreement within the coming months. The negotiations aim to remove tariff barriers, open markets for investment and services, and seek cooperation and convergence on regulatory measures and product standards. Furthermore, the agenda also foresees talks on a variety of rules-based issues, such as the protection of intellectual property rights and aspects of trade related to labor, the environment, and competition policy. Concerning tariff barriers, the declared aim of the EU and U.S. is to remove all customs duties on transatlantic trade in industrial and agricultural products. There are open questions, however, regarding the degree to which "highly sensitive" products will ... 374c0aad-89fa-4091-ba8d-9a4673953ad0 Thu, 28 Feb 2013 10:27:13 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Should-Have-Known-Standard-Applied-to-CDA-Statute-of-Limitations In what seems likely to be a major landmark in the evolving interpretation of the CDA statute of limitations, the ASBCA has held that the statute began to run in 1999, when a DCMA price analyst had all the information the government needed to recognize that it had a claim for an alleged CAS violation, even though the responsible CO may not have been aware of the claim until an audit report was issued in 2006. The ASBCA held that, in the absence of any evidence of trickery or concealment, the government "should have known" that it had a claim based on the contractor's 1999 cost proposal that appeared to be inconsistent with its disclosed accounting practice and that the government could not unilaterally extend the statute of limitations by failing to perform an audit that put the CO on actual notice that there might be a claim. 8c7efdb0-18c8-49d7-a415-a2d619766f08 Fri, 08 Mar 2013 13:26:06 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/ICANN-Publishes-New-gTLD-Contention-Sets-as-Identified-by-Its-String-Similarity-Experts Background ICANN defines a "contention set" as a group of two or more applications proposing identical or confusingly similar gTLD strings. All applications for identical strings were automatically assigned to exact-match contention sets. During the initial evaluation phase, ICANN's String Similarity Review Panel reviewed the remaining applications to identify those that it believed to be visually similar to other applied-for strings or to existing TLDs. Those applications that the panel deemed to be similar to a degree that was likely to result in consumer confusion were grouped together into non-exact-match contention sets. This decision is of extreme importance to the implicated applications because of the nature of ICANN's contention set process: only one application from each contention set can ultimately be delegated. ICANN's latest communication Although the publication of the list of contention sets was originally scheduled for March 1st, ICANN made the list available on ... 1b7ee0e0-26a5-4559-97ac-726f8ffca88e Fri, 01 Mar 2013 14:11:48 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/SEC-Releases-2013-Examination-Priorities On February 21, 2013, the Securities & Exchange Commission released its examination priorities for 2013. The 13-page release can be found here. The highlights for investment advisers are as follows: Custody Counts. The first (of 12) risk and policy areas identified by the Commission for advisers concerns compliance with custody requirements. Recent OCIE exams have identified failures to comply with the letter and spirit of the custody rule. Staff will check to ensure that managers recognize when they have custody, whether managers are complying with the "surprise exam" requirement, whether the "qualified custodian" requirement is being satisfied, and other related matters. Advisers may want to double-check their ADV disclosures in advance. Conflicts of Interest Related to Compensation Arrangements. Many funds pay finders and brokers for their help in raising capital. SEC staff will review financial and other records (presumably including PPMs, slide decks, other offering materials, ADVs Parts ... d8adf735-3f51-4091-9bd7-2ac631a3f939 Tue, 19 Mar 2013 18:42:12 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Managed-Care-Lawsuit-Watch-February-2013 This summary of key lawsuits affecting managed care is provided by the Health Care Group of Crowell & Moring LLP. If you have questions or need assistance on managed care law matters, please contact Art Lerner or any member of the health law group. Please click to view the full Crowell & Moring Managed Care Lawsuit Watch archive. Cases in this issue: FTC v. Phoebe Putney Health System, Inc. MHA, LLC v. Aetna Health, Inc. et al. Jacks v. Meridian Resource Co., LLC & Blue Cross Blue Shield of Kansas City Mondry v. American Family Mutual Insurance Company United States v. Sharma Saint Alphonsus Medical Center ... 575c3cfc-94fd-4c4e-b9c4-55f4d892a772 Fri, 01 Mar 2013 14:38:36 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/What-You-Need-to-Know-About-the-FTCs-COPPA-Revisions On December 19, 2012, the Federal Trade Commission ("FTC") issued final amendments to the Children's Online Privacy Protection Rule ("COPPA Rule"). These amendments implement the Children's Online Privacy Protection Act ("COPPA")1 and will go into effect on July 1, 2013. Advertisers should be aware of the changes to the COPPA Rule, especially because the changes provide for increased FTC enforcement in the area of children's privacy protection. Most notably, the revised COPPA Rule expands the scope of who may be subject to the rule, and the kind of information that is covered by the rule. Some online operators and marketing practices that were not covered before may now be considered within the bounds of FTC's COPPA enforcement powers, and potentially subject to fines if they fail to comply. Who is subject to the amended COPPA Rule?  If you or your organization operates a website or online service that ... 7804c8ca-0009-4c5f-82d3-cd51aed9cada Tue, 26 Feb 2013 15:27:58 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Clean-Energy-Award-Polluted In Nexant, Inc (Jan. 30, 2013), GAO sustained the protest of Nexant, Inc., represented by Crowell & Moring, to the award of a clean energy consulting contract by USAID, finding that USAID engaged in misleading discussions, based its evaluation on a flawed methodology that led to numerous unreasonable evaluation conclusions, and did not reasonably explain its basis for choosing the awardee's higher cost proposal. While GAO ultimately declined to rule on the issue of what weight it should afford to a source selection decision document (SSDD) drafted after both contract award and the filing of a protest, it did note that there is "a reasonable concern" whether such an after-the-fact SSDD can accurately represent the fair and considered judgment of the agency. c2adeb1c-7852-4ca9-8635-c50ab2099a2b Wed, 20 Mar 2013 11:57:55 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/CMS-Proposed-2014-Payment-and-Policy-Updates-for-Medicare-Health-Drug-Plans-Draft-Call-Letter On February 22, 2013, the Centers for Medicare & Medicaid Services (CMS) released its 2014 Advance Notice and draft Call Letter updating its payment policies for Medicare Advantage plans (Part C) and Medicare prescription drug plans (Part D). Comments on the proposed Advance Notice and draft Call Letter must be submitted by March 1, 2013. The final 2014 Rate Announcement and Call Letter will be published April 1, 2013. Click here to review the 2014 Advance Notice and draft Call Letter. The Advance Notice discusses changing CMS's actuarial calculation and risk score models for Medicare Advantage plans to comply with the requirements of the Affordable Care Act. CMS also proposes data collection and analysis for Health Risk Assessments (HRAs), which are enrollee risk assessments done by Medicare Advantage plans. MA plans must flag any diagnoses collected in MA enrollee risk assessments, which CMS believes will encourage adequate follow-up by plans for these ... 38c99b56-7cc5-4930-b003-8b9f2922b389 Fri, 15 Mar 2013 15:38:35 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/HIPAA-Final-Rule-Expands-Liability-for-Violations-Clarifies-Penalty-Assessment-Methodology The Health Insurance Portability and Accountability Act (HIPAA) final rule expands liability for HIPAA violations and clarifies how the U.S. Department of Health and Human Services (HHS) will calculate the penalties for such violations. The final rule subjects an expanded population of entities (e.g., covered entities, business associates, and subcontractors) to larger monetary fines for violating an increased number of regulations. Fortunately, this increased liability is accompanied by more detailed guidance on the methodology HHS will use to assess monetary penalties. Together, these changes have significant implications for covered entities and business associates and highlight the importance of implementing sufficient security and privacy protocols. One of the most anticipated changes to the final rule is the scope of HHS's enforcement authority. In the final rule, HHS significantly expanded liability by: (1) subjecting the HITECH Act and implementing regulation violations to a Civil Monetary Penalty (CMP); (2) subjecting business ... a70a7581-0b83-4e54-a628-98d25ed8266d Fri, 22 Feb 2013 15:09:36 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/First-Ever-RICO-Claim-Against-NPEs-Dismissed-But-Other-Claims-Including-RAND-Commitments-Remain-Viable Operating companies continue to search for ways to repel ever increasing infringement litigation attacks by non-practicing entities (NPEs). Their newest salvo, the much-watched claim by several wireless local area network (WLAN) product manufacturers against an NPE under the Racketeer Influenced and Corrupt Organizations Act (RICO), however, was dismissed last week by an Illinois federal court. But the decision offers hope for the theory, and allowed other claims to stand.  On February 4, 2013, the U.S. District Court for the Northern District of Illinois dismissed the RICO claim brought by WLAN product manufacturers against Innovatio IP Ventures, a well known NPE.1 The manufacturers claimed that Innovatio engaged in "a pattern of unlawful racketeering activity" through a scheme to "deceive and defraud" end-users of Wi-Fi internet in an effort to obtain licensing fees.2  Specifically, the complaint alleged that Innovatio violated RICO by sending thousands of licensing demand letters to businesses around ... 6d3e5413-8af7-41d8-adfc-b7cb32a47985 Fri, 22 Feb 2013 15:44:33 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/Coming-to-a-Site-Near-You-Unmanned-Aircraft-Systems-Testing On February 14, the FAA released its information request for unmanned aircraft system (UAS) research and test sites, under which the FAA is seekings proposals for the development and operation of six test sites to be used to conduct research regarding the integration of UAS's into the national airspace system, which Congress has mandated by 2015. Despite lingering privacy concerns, the FAA's proposal to move ahead with test sites is likely to grab the attention of both traditional aircraft and avionics manufacturers seeking new markets and also other industries that may be affected by the emergence of civilian UAS's, including agriculture, oil and gas exploration, law enforcement, and security. 61bda5f3-d682-4766-a5c9-444d6d599f56 Mon, 25 Feb 2013 10:02:05 GMT http://www.crowell.com/NewsEvents/AlertsNewsletters/all/CMS-Announces-Medicare-Advantage-and-Prescription-Drug-Program-MLR-Proposed-Rule-Largely-Follows-Commercial-MLR-Rules CMS Announces Medicare Advantage and Prescription Drug Program MLR Proposed Rule—Largely Follows Commercial MLR Rules On February 15, 2013, CMS issued a proposed rule implementing the Affordable Care Act's (ACA) medical loss ratio requirement for Medicare Advantage and the Prescription Drug Program (PDP) as set forth in section 1103 of Title I, Subpart B of the Health Care and Education Reconciliation Act.  The ACA requires Medicare Advantage Organizations (MAOs) and Part D sponsors (referring to stand-alone Part D, as opposed to MA-PD, contracts) to spend 85% of contract revenue (including any member premiums) on the provision of clinical services, prescription drugs, quality improving activities (as defined in the proposed rule) and direct benefits to beneficiaries via reduced Part B premiums. The MLR rule will be effective January 1, 2014. The proposed rule is scheduled for publication in the Federal Register on February 22, 2013, with comments due by April ...