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Publications & Presentations

We encourage you to peruse this Publications & Presentations section for timely analysis and industry insights, including bylined articles, client alerts, white papers, practice and industry newsletters, audio and video broadcasts, featuring interviews with our lawyers, as well as case studies highlighting compelling legal challenges our clients have faced.

Also, please visit our Events page to learn more about upcoming seminars, CLE programs, and other presentations which may be of interest.

Recent Publications

A Lifelong Commitment: FDA Releases Postmarket Guidance on Cybersecurity Risk Management for Medical Device Manufacturers
Authors: Brian E. Finch, Gerry Hinkley, Kristi V. Kung, Caitlin Bloom Stulberg

On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as well as FDA staff on the management of cybersecurity vulnerabilities in networked medical devices (such as insulin pumps, pacemakers and defibrillators) already in the marketplace.1

India Takes the Next Step in Forming Its Nuclear Liability Framework
Authors: Sanjay J. Mullick, Elina Teplinsky, James A. Glasgow, Stephen B. Huttler, Moushami P. Joshi

On February 4, 2016, India submitted to the International Atomic Energy Agency (IAEA) its Instrument of Ratification of the Convention on Supplementary Compensation for Nuclear Damage (CSC). Under the applicable rules, the CSC will take effect for India 90 days after ratification, giving it access to the international nuclear liability damages pool. Ratification of the CSC, along with guidance on India’s nuclear liability law issued last year by the Ministry of External Affairs (MEA) and a nuclear insurance pool currently being formed by the General Insurance Corporation (GIC), constitute three pillars India has put in place to form its nuclear liability framework. The question is whether these will be enough to now open India’s nuclear market for business, particularly for U.S. suppliers.

Supreme Court Blocks Obama Administration’s Clean Power Plan
Authors: Jeffrey A. Knight, Matthew W. Morrison, Bryan M. Stockton, Brendan J. Hennessey*

On February 9, 2016, the Supreme Court of the United States issued an unprecedented grant of applications to stay the Clean Power Plan, President Obama’s signature climate change rule. The rule is being challenged in the U.S. Court of Appeals for the District of Columbia Circuit, and the stay prevents the rule from becoming effective until the DC Circuit issues a ruling on the merits and the Supreme Court takes final action on appeals from that ruling. Appeals of the DC Circuit ruling are all but assured and, if the DC Circuit decides the case on an expedited basis as is expected, the Supreme Court could consider the case in the Court’s next term starting October 2016. Because the Supreme Court is unlikely to issue a ruling on the fate of the Clean Power Plan before 2017, the stay will mean that the current administration will have no further role in shaping the rule (if remanded) or implementing it (if upheld).

Public Hospital Bankruptcy Under Chapter 9: A Success Story and a Powerful Tool
Source: LinkedIn
Author: Brian R. Hayag

To the extent authorized by a State, Chapter 9 of the Bankruptcy Code allows municipalities (defined as a “political subdivision or public agency or instrumentality”) of that State – including public hospitals – to reorganize their debts in the face of insolvency. Municipalities achieve this goal through implementation of a court-approved plan of adjustment. Although the standards for confirming (approving) a Chapter 9 plan resemble the well-established standards for confirming a Chapter 11 plan, differences exist. These differences can be particularly impactful on the ability to confirm a plan that does not pay creditors in full over their objection. Accordingly, public hospitals should be aware of Chapter 9’s different standards for ensuring continuity of the hospital’s operations and preserving funds to enable continued operations and necessary improvements.

EU and U.S. Reach Data Transfer Agreement: Perhaps a Shield, But No Silver Bullet
Authors: Rafi Azim-Khan, Mercedes K. Tunstall, Steven P. Farmer, Andrew Caplan

On February 2, 2016, the European Commission and the U.S. Department of Commerce reached an accord on a new transatlantic data transfer protocol. Nicknamed the EU-U.S. Privacy Shield, the framework would replace the 15-year-old Safe Harbor, which was invalidated by the European Court of Justice on October 6, 2015.1 Clocking in at the thirteenth hour (two days after the European Commission’s internal January 31st deadline), the announcement may elicit an initial sigh of relief from executives of the several thousand U.S. companies that had relied upon the now-defunct Safe Harbor. But is it the silver bullet some think it might be?

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