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Carolyn Alenci

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To…more

FDA, Pharmaceutical, Prescription Drugs, Security, Supply Chain

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Samuel Apicelli

Taking On The Internet For Your Client's Reputation

My cell phone rings at 6:30 on a Friday evening. It's the CEO of a client company and she is panicked. Hysterical. It turns out she was doing some "old-fashioned" investigating by performing Google searches on herself and the…more

DMCA, Reputation Management, Terms of Use, User-Generated Content, Websites

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Jonathan Armstrong

Renewed Focus on European Cookie Laws

We have reported previously in our Duane Morris Alerts about the progress with new cookie laws across Europe. The laws were introduced following a European Union Directive [the E-Privacy Directive (2009/136/EC)] at the end of…more

Cookies, Cybersecurity, Data Protection, EU, Internet

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Joseph J. Aronica

DOJ and the SEC Issue New FCPA Guidance

On November 14, 2012, the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) published "A Resource Guide to the U.S. Foreign Corrupt Practices Act." Through the Guide, DOJ and the SEC provide the most…more

Compliance, DOJ, FCPA, FCPA Resource Guide, SEC

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David Augustin

Philadelphia Creates Land Bank for City to Sell and Purchase Vacant Property

On January 13, 2014, Philadelphia Mayor Michael Nutter signed into law Bill No. 130156-A, creating a municipal land bank for the city. With this law, Philadelphia became the largest U.S. city to adopt a land bank and joins more…more

Land Bank, Urban Planning & Development

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Frederick Ball

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To…more

FDA, Pharmaceutical, Prescription Drugs, Security, Supply Chain

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G. Matthew Barnard

Guide to Publicly Offered Private Placements Under New Rule 506(c)

Background: A company that needs capital to expand its business or fund its operations often chooses to sell stock or other securities to investors in order to meet its funding requirements. All offerings of stock or…more

Bad Actors, Dodd-Frank, Filing Requirements, Investors, JOBS Act

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Luke Bartlinski

Tax Deadlines Still in Effect, Despite Government Shutdown

The U.S. federal government shutdown does not alleviate the October 15 filing deadline or other upcoming filing and payment requirements. The current state of the government shutdown has many taxpayers questioning whether…more

Filing Deadlines, Government Shutdown, IRS, Tax Liens, Tax Refunds

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William Barwick

First ADA ATM Accessibility Class Action Lawsuit Is Filed in Atlanta

The first of what is likely to be many Americans with Disabilities Act (ADA) ATM accessibility class action lawsuits against Atlanta-area banks was filed in federal district court in Atlanta last week. The lawsuit was filed by…more

ADA, ATMs, Class Action

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Demetrios C. "Jim" Batsides

Potential Liability for Wrongful-Birth Claims

On Nov. 14, 2012, in Sernovitz v. Dershaw, 2012 Pa. Super. 248 (Pa. Super. Ct. 2012), the Pennsylvania Superior Court held that 42 Pa.S.C.A. § 8305, which prohibited the tort claims of wrongful birth and wrongful life, was…more

Article III, Wrongful Birth

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Christopher Bender

Amendments to Pennsylvania’s Uniform Condominium Act and Uniform Planned Communities Act

Recently, Pennsylvania Governor Tom Corbett signed into law House Bill 1122 (the "Amendment"), which amends the Uniform Condominium Act and the Uniform Planned Community Act (together the "Acts") by extending the time period for…more

Condominiums, New Legislation

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Neville M. Bilimoria

WellPoint Pays HHS $1.7 Million to Settle HIPAA Security Violations

Covered Entities Cautioned Regarding Use of Business Associates - On July 8, 2013, health insurer WellPoint, Inc. entered into a Resolution Agreement with the U.S. Department of Health and Human Services, Office for Civil…more

HHS, HIPAA, Policy Violations, Settlement, WellPoint

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Jess Booth

FDA Draft Guidance Details Key Cybersecurity Management Measures Expected in Medical Device Submissions

Last month, the U.S. Food and Drug Administration (FDA) issued its Draft Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Recognizing the increasing need for effective…more

Cybersecurity, FDA, Medical Devices, Mobile Devices, Risk Management

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Robert Bramnik

SEC Targets Investment Adviser Community

The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser…more

Chief Compliance Officers, Compliance, Corporate Counsel, Enforcement, Investment Adviser

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Eric Breslin

Use It or Lose It: U.S. Supreme Court Holds the SEC Must Bring Civil Enforcement Actions Within Five Years of Wrongful Conduct

On February 27, 2013, the United States Supreme Court put a stop to the Securities and Exchange Commission's (SEC) practice of bringing civil enforcement actions outside the five-year statute of limitations. In an opinion by…more

Civil Monetary Penalty, Discovery Rule, Gabelli v SEC, SCOTUS, SEC

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Gregory Brodek

State Medicaid Fraud Control Units' Data Mining Likely to Increase Through Federal Funding

On May 17, 2013, the Office of Inspector General, U.S. Department of Health and Human Services (OIG), announced a final regulation that would permit, effective June 17, 2013, state Medicaid fraud control units (MFCU) to use…more

Affordable Care Act, Data Mining, Federal Funding, Fraud, Healthcare

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Marc D. Brookman

Amendments to Pennsylvania’s Uniform Condominium Act and Uniform Planned Communities Act

Recently, Pennsylvania Governor Tom Corbett signed into law House Bill 1122 (the "Amendment"), which amends the Uniform Condominium Act and the Uniform Planned Community Act (together the "Acts") by extending the time period for…more

Condominiums, New Legislation

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Valentine Brown

Immigration Impact: Recognizing and Reducing Liability in Corporate I-9 Procedures

2012 was a record year for Immigration and Customs Enforcement-Homeland Security Investigations (HSI), the agency charged with I-9 enforcement. In 2012, HSI commenced 3,004 I-9 investigations and completed 495, charging…more

Customs and Border Protection, DHS, Employer Liability Issues, Foreign Nationals, Fraud

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Joseph Burton

EU Debate over Cybersecurity Laws

We gave a progress report earlier this week in our Alert on the European Commission's plans for wide-ranging changes to data protection laws. It is worth remembering that the European Commission is also considering additional…more

Cybersecurity, EU, EU Data Protection Laws, European Commission

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Sharon Caffrey

Supreme Court Holds FDCA Preempts Common Law Design-Defect Claim Against Generic Drugs

On June 24, 2013, the U.S. Supreme Court held in Mutual Pharmaceutical Co., Inc. v. Bartlett that the Federal Food, Drug, and Cosmetic Act (FDCA) preempted the respondent's common law claim for damages arising from the alleged…more

Design Defects, Drugs, FDA, FDCA, Generic Drugs

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Christiane Campbell

Taking On The Internet For Your Client's Reputation

My cell phone rings at 6:30 on a Friday evening. It's the CEO of a client company and she is panicked. Hysterical. It turns out she was doing some "old-fashioned" investigating by performing Google searches on herself and the…more

DMCA, Reputation Management, Terms of Use, User-Generated Content, Websites

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Vincent Capuano

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug…more

Biologics, Biosimilars, FDA, Notice Requirements, Pharmaceutical

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James Carbin

New York Appeals Court Reverses Itself in K2 Investment Group Decision; Reaffirms Earlier Ruling in Servidone

In a decision notable for several reasons, the New York State Court of Appeals—the state's highest court—reversed itself in K2 Investment Group, LLC v. American Guarantee & Liability Insurance Co. [21 NY3d 384 (2014)] and…more

Breach of Duty, Duty to Defend, K2 Investment Group, Servidone

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Piero Carbone

UK Budget Speech - Key Points

The UK's Chancellor of the Exchequer, George Osborne, delivered his annual Budget Speech on 19 March 2014. More details of measures announced will be known when a new draft of the Finance Bill 2014 is published on 27 March. A…more

Economic Development, Tax Reform, UK

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Erin Carter

"Every Breath" Theory: On Its Last Breaths?

The "every breath," or cumulative exposure opinion, has been proffered by plaintiffs' experts in asbestos cases to prove specific causation, regardless of the type of product or amount of exposure. The U.S. District Court for…more

Asbestos, Asbestos Litigation, Daubert Ruling, Every Breathe Theory, Evidence

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Gerard Catalanello

Second Circuit Ruling Appears to Limit Ability of U.S. Bankruptcy Courts to Assist Foreign Debtors

In Drawbridge Special Opportunities Fund LP v. Barnet (In re Barnet), Case No. 13-612, 2013 WL 6482499 (2d Cir. Dec. 11, 2013), the United States Court of Appeals for the Second Circuit held that in order for a foreign…more

Chapter 15, Commercial Bankruptcy, Debtors, Foreign Nationals

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David Charapp

"Who Wants to Be a Millionaire?" Profit-Sharing Verdict Upheld by Ninth Circuit

On December 3, 2012, the U.S. Court of Appeals for the Ninth Circuit in Celador International, Inc. v. American Broadcasting Companies, Inc., et al. upheld an interesting jury verdict, resulting in a $319 million judgment…more

License Agreements, Motion Picture Industry, Profit Sharing

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Rosanne Ciambrone

Bitcoin Exchange Mt. Gox Files for Bankruptcy Protection; May Have Broader Implications for Digital Currency Industry

On February 28, 2014, international Bitcoin exchange Mt. Gox filed for bankruptcy protection in Tokyo, capping what is likely the most tumultuous month yet in the history of the controversial virtual currency. Mt. Gox—the…more

Bitcoins, Mt.Gox, Virtual Currency

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Meghan Claiborne

U.S. Supreme Court Restricts Challenges to Pretrial Seizure of Defense Funds

The U.S. Supreme Court recently weakened a criminal defendant's ability to challenge the Government's pretrial seizure of assets that a defendant has allocated for mounting a defense. In Kaley v. United States, the Court…more

Frozen Assets, Kaley v. United States, Probable Cause, SCOTUS

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Lisa Clark

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary…more

FCC, FDA, FTC, Healthcare, HHS

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Marcus Colabianchi

Glaski Decision Appears to Place Lenders on Notice to Verify Accuracy and Effectiveness of Loan Assignments

The recent decision in Glaski v. Bank of America, National Association, et al., 160 Cal. Rptr. 3d 449 (2013), may, at least in certain circumstances, impact the ability of residential mortgage-backed security and commercial…more

Assignments, Bank of America, Lenders, Mortgage-Backed Securities, Mortgages

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Allison Cooper

Five Ways to Invite (and Avoid) a Malpractice Lawsuit

A recent headline in another leading legal publication asserted: "Malpractice claims are on the rise." As most lawyers know, it is not hard for even legally-aware professionals like themselves to be the defendants in a lawsuit…more

Attorney Malpractice, Career Development, Legal Ethics, Professional Liability

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Leslie Croland

SEC Eliminates Prohibition on General Solicitation in Certain Private Securities Offerings

On July 10, 2013, the U.S. Securities and Exchange Commission (the "SEC") (a) adopted final rules to implement Section 201(a) of the Jumpstart Our Business Startups Act by eliminating the prohibition on general solicitation in…more

General Solicitation, JOBS Act, Private Placements, Regulation D, Rule 144A

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Bruce Czachor

A Guide to Regulation M: Regulating Market Activity During a Public Offering

Regulation M is intended to prevent potentially manipulative practices by underwriters, issuers, selling security holders and other participants in securities offerings. Understanding the key aspects of Regulation M is essential…more

Public Offerings, Regulation M, SEC, Securities Exchange Act

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John Dellaportas

Satisfaction Clauses -- A Trap For The Unwary In Terminating M&A Transactions

Your company might undertake a merger or acquisition for any number of reasons. It might wish to expand into new markets; to acquire valuable technology or other assets; and/or, of course, simply to grow the bottom line. No…more

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Rudolph J. Di Massa Jr

Bitcoin Exchange Mt. Gox Files for Bankruptcy Protection; May Have Broader Implications for Digital Currency Industry

On February 28, 2014, international Bitcoin exchange Mt. Gox filed for bankruptcy protection in Tokyo, capping what is likely the most tumultuous month yet in the history of the controversial virtual currency. Mt. Gox—the…more

Bitcoins, Mt.Gox, Virtual Currency

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Stephen DiBonaventura

House Ways and Means Committee Releases Proposal on Tax Reform

On February 26, 2014, House Ways and Means Committee Chairman David Camp (R-Mich.) released his plan for U.S. federal tax reform by introducing draft legislation called the "Tax Reform Act of 2014." The proposal is intended to…more

Alternative Minimum Tax, Capital Gains, Corporate Taxes, Medical Devices, Tax Deductions

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Robert H. Dietrick

U.S. Supreme Court Restricts Challenges to Pretrial Seizure of Defense Funds

The U.S. Supreme Court recently weakened a criminal defendant's ability to challenge the Government's pretrial seizure of assets that a defendant has allocated for mounting a defense. In Kaley v. United States, the Court…more

Frozen Assets, Kaley v. United States, Probable Cause, SCOTUS

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Frank DiGiacomo

Third-Party Software Providers— Will the DGE Take a Hard Look at Them?

Unlock your iPhone and today you can swipe through the plethora of apps from the multitude of independent software providers available at your fingertips. As our phones have transformed into ‘smart phones,’ other forms of…more

Casinos, Gaming, Gaming Equipment, Gaming Legislation, Independent Contractors

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Michelle Donovan

Sunrise Periods for First Wave of gTLDs Are Now Open

ICANN, the International Corporation for Assigned Names and Numbers, has approved the first wave of generic top-level domains (gTLDs) for release. The introduction of new gTLDs triggers a mandatory 30-day "Sunrise Period" to…more

gTLD, ICANN, Trademark Clearinghouse, Trademarks

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Erin Duffy

Refill Reminder Exception to the Privacy Rule Created by the HITECH Act

The passing of the Health Information Technology for Economic and Clinical Health Act (HITECH) resulted in multiple changes regarding existing protection of protected health information (PHI) under the Health Insurance…more

HHS, HIPAA, HIPAA Omnibus Rule, HITECH, OCR

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Christopher Durham

Can an Employer Ask Employees to Keep HR Investigations Confidential?

Employee confidentiality during HR investigations is a "no-brainer" best practice – right? Not so fast – a recent decision by a labor board judge threatens to interfere with employers' ability to conduct investigations on a…more

Boeing, Confidential Employer Investigations, NLRA, NLRB, Section 7

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Joel Ephross

SBA Rules: Investment Funds Can Now Be Majority Owners of SBIR Companies

The Small Business Administration (SBA) recently amended the rules relating to its Small Business Innovation Research (SBIR) program and Small Business Technology Transfer (STTR) program. The new SBA rules implement the…more

Affiliates, Business Ownership, Hedge Funds, Investment Funds, Private Equity

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Charles Fastenberg

Recent Changes in New York City's Standard Construction Contract

With its new Standard Construction Contract, issued in December 2013, the City of New York (the "City") has implemented numerous significant changes as compared with its 2008 standard contract. This Alert briefly summarizes some…more

Construction Contracts, Construction Disputes, Contract Drafting, Prevailing Wages

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James J. Ferrelli

The Parol Evidence Rule: Forget Blue State/Red State, New Jersey is an Egg State

Which came first, the chicken or the egg? This age-old causality dilemma dates back to ancient philosophers, but can also be viewed as a metaphor for the debate over the breadth of the parol evidence rule. Ah, the parol evidence…more

Contract Interpretation, Parol Evidence

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Justin Fields

Five Ways to Invite (and Avoid) a Malpractice Lawsuit

A recent headline in another leading legal publication asserted: "Malpractice claims are on the rise." As most lawyers know, it is not hard for even legally-aware professionals like themselves to be the defendants in a lawsuit…more

Attorney Malpractice, Career Development, Legal Ethics, Professional Liability

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Eric D. Frank

Third-Party Software Providers— Will the DGE Take a Hard Look at Them?

Unlock your iPhone and today you can swipe through the plethora of apps from the multitude of independent software providers available at your fingertips. As our phones have transformed into ‘smart phones,’ other forms of…more

Casinos, Gaming, Gaming Equipment, Gaming Legislation, Independent Contractors

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John Friskey

Sweeping Changes to the Pennsylvania Tax Code - The Passage of Pa. House Bill 465

House Bill 465, also known as Act 52, was signed into law by Pennsylvania Governor Tom Corbett on July 9, 2013. The Bill makes substantial changes to the Pennsylvania tax code as an integral part of the 2013–2014 budget. While…more

Family Businesses, Income Taxes, Inheritance Tax, Net Investment Income, Pass-Through Entities

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Patrick Gallagher

U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill"), which proposes a structure for federal oversight of compounding pharmacies. The House Bill is the latest federal…more

Drug Compounding, Drug Safety, FDA, Outsourcing, Pharmacies

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Melissa Geller

Use It or Lose It: U.S. Supreme Court Holds the SEC Must Bring Civil Enforcement Actions Within Five Years of Wrongful Conduct

On February 27, 2013, the United States Supreme Court put a stop to the Securities and Exchange Commission's (SEC) practice of bringing civil enforcement actions outside the five-year statute of limitations. In an opinion by…more

Civil Monetary Penalty, Discovery Rule, Gabelli v SEC, SCOTUS, SEC

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Michael Gillen

Don't Miss the FBAR Filing Deadline

Despite the Department of the Treasury's Financial Crimes Enforcement Network (FinCEN) publishing final regulations for reporting bank accounts, securities accounts and other financial accounts located in a foreign country on…more

FBAR, Filing Requirements, FinCEN, Foreign Financial Accounts, Income Taxes

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Mitch Goldman

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary…more

FCC, FDA, FTC, Healthcare, HHS

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Brian Goldstein

OFAC Issues General License G Regarding Certain Academic Exchanges and Educational Services in Iran

On March 19, 2014, the Office of Foreign Assets Control (OFAC) issued General License G pertaining to certain academic exchanges and the exportation or importation of certain educational services to Iran. The General License…more

Iran, OFAC

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John Goselin

SEC Targets Investment Adviser Community

The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser…more

Chief Compliance Officers, Compliance, Corporate Counsel, Enforcement, Investment Adviser

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Steven Gray

Public Benefit Corporations Open for Business in Delaware

Delaware is the 19th state to adopt a corporate business form for enterprises that wish to combine "for profit" pursuits and "public benefits." On August 1, 2013, Delaware began permitting the organization of for-profit…more

Choice of Entity, New Legislation, Non-Profits, Public Benefit Corporation

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Walter Greenhalgh

District Court Clarifies Distinction Between Burdens of Proof on Stay Relief and Adequate Protection in American Airlines Bankruptcy

In AMR Corporation, et al., Debtors, Case No. 12-3967, 2013 WL 1339123 (S.D.N.Y. April 3, 2013), the United States District Court for the Southern District of New York acknowledged that to be granted relief from the automatic…more

Adequate Assurances, American Airlines, Burden of Proof, Chapter 11, Collateral

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Stephan Gribok

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary…more

FCC, FDA, FTC, Healthcare, HHS

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Michael Grohman

Home Is Where You Hang Your Hat: The Significance of Domicile Planning

A debtor, regardless of state residence, can seek protection from his or her creditors in the federal bankruptcy courts. However, the state in which the debtor resides or, more accurately, is "domiciled," will determine which…more

Debtors, Domicile, Estate-Tax Exemption, Exempt Assets, Financial Planning

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David I. Haas

Pa. Superior Court Extends Protection of Implied Warranty of Habitability to Subsequent Purchasers of a Newly Constructed Home

For the first time, the Superior Court of Pennsylvania has extended the protection of the implied warranty of habitability to the second or subsequent purchaser of a newly constructed home in Conway v. The Cutler Group, 2012 Pa…more

Implied Warranty of Habitability, Latent Defects

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Elinor Hart

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft…more

Drug Compounding, FDA, FDCA, Fees, Outsourcing

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Nanette Heide

SEC Enforcement Actions Against Private Equity: Get Ready for More

In a speech delivered at the Private Equity International Conference on January 23, 2013, in New York, Bruce Karpati, Chief of the U.S. Securities and Exchange Commission (SEC) Enforcement Division's Assets Management Unit,…more

Asset Management, Asset Valuations, CEOs, CFOs, Conflicts of Interest

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Robert Hendrickson

Public Works Projects and Municipal Bankruptcies

The good news is that public works construction projects for municipalities are projected to remain a major sector of construction activity for the foreseeable future. The not-so-good news is that municipal bankruptcy filings…more

Chapter 9, Construction Contracts, Creditors, Debtors, Executory Contracts

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William Heuer

Second Circuit Ruling Appears to Limit Ability of U.S. Bankruptcy Courts to Assist Foreign Debtors

In Drawbridge Special Opportunities Fund LP v. Barnet (In re Barnet), Case No. 13-612, 2013 WL 6482499 (2d Cir. Dec. 11, 2013), the United States Court of Appeals for the Second Circuit held that in order for a foreign…more

Chapter 15, Commercial Bankruptcy, Debtors, Foreign Nationals

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Linda Hollinshead

Leave-of-Absence Issues Managers Need to Know

In many organizations, the human resources function is handled by specialists who guide managers' decision-making to ensure consistency with myriad employment laws. It is not uncommon, however, for HR professionals to get…more

ADA, FMLA, Hiring & Firing, Human Resources Professionals, Investigations

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Sheila Hollis

FERC Continues Its Enforcement of Hydropower Safety Regulations with Approval of Stipulation and Consent Agreement

On January 15, 2014, the Federal Energy Regulatory Commission (FERC) approved a stipulation and consent agreement between the FERC's Office of Enforcement (Enforcement), Erie Boulevard Hydropower, L.P. (Erie) and Brookfield…more

Clean Energy, FERC, Hydropower, Renewable Energy

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James Holman

Strategies for Avoiding the Headache of Preference Liability

Although business bankruptcy filings have trended down in recent months, the lingering legacy of litigation prompted by the surge in filings at the outset of the U.S. financial crisis remains with us and continues to strike many…more

Chapter 11, Creditors, Preferential Transfers

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Stephen Honig

Crowdfunding: Not as simple as it looks

In October, the Securities and Exchange Commission promulgated draft rules to implement “crowdfunding” in securities sales. Release 33-9470’s length (almost 600 pages) suggests that the simple idea contained in the 2012…more

Crowdfunding, JOBS Act, SEC

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Robert B. Hopkins

U.S. Supreme Court Issues Significant Forum-Selection Decision

There has been confusion in the courts over the years regarding the appropriate mechanism to enforce forum-selection clauses, which are now routinely included in many commercial and personal contracts. Such clauses typically…more

Forum, Forum Selection Clause, SCOTUS

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Dennis Hough

Manufacturers Beware: DOE's Program of Compliance with Energy and Water Conservation Standards Comes to Life!

Unknown to many manufacturers of appliances, energy-consuming devices and water fixtures, there are a host of energy conservation standards that regulate the performance of these products. While the energy conservation standards…more

Compliance, Covered Products, DOE, Enforcement, Manufacturers

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Natalie F. Hrubos

3 Employer Pitfalls in Donning and Doffing Policies

Donning and doffing is a hot area of wage and hour law that often leads to class and collective actions and, as a result, creates significant potential liability and litigation costs for employers. These cases involve whether…more

Class Action, Collective Actions, Employee Rights, Employer Liability Issues, FLSA

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Amelia Huskins

First ADA ATM Accessibility Class Action Lawsuit Is Filed in Atlanta

The first of what is likely to be many Americans with Disabilities Act (ADA) ATM accessibility class action lawsuits against Atlanta-area banks was filed in federal district court in Atlanta last week. The lawsuit was filed by…more

ADA, ATMs, Class Action

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Richard Jaffe

SEC Enforcement Actions Against Private Equity: Get Ready for More

In a speech delivered at the Private Equity International Conference on January 23, 2013, in New York, Bruce Karpati, Chief of the U.S. Securities and Exchange Commission (SEC) Enforcement Division's Assets Management Unit,…more

Asset Management, Asset Valuations, CEOs, CFOs, Conflicts of Interest

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Arvind Jairam

Federal Circuit Reverses District Court on Claim Construction in Patent Suit Involving Google's Street View

On March 14, 2014, the U.S. Court of Appeals for the Federal Circuit ruled in a patent appeal case involving Google's Street View technology on a topic in patent law that has received considerable attention recently—claim…more

Claim Construction, Exclusive Jurisdiction, Federal Jurisdiction, Google, Infringement

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L. . Norwood Jameson

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug…more

Biologics, Biosimilars, FDA, Notice Requirements, Pharmaceutical

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Sandra Jeskie

New TCPA Rules Effective October 16, 2013

In 2012, the Federal Communications Commission (FCC) revised its regulations under the Telephone Consumer Protection Act ("TCPA"). On October 16, 2013, the final amendments to these regulations requiring prior express written…more

Cell Phones, Compliance, FCC, Robocalling, Spam

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Suzan Jo

U.S. Supreme Court Lowers the Bar for Class Certification in Private Securities Fraud Actions

On February 27, 2013, the U.S. Supreme Court issued its opinion in Amgen, Inc. v. Connecticut Retirement Plan and Trust Funds, 568 U.S. ___ (2013), resolving a conflict among the Courts of Appeals "over whether district courts…more

Amgen Inc. v Connecticut Retirement Plans, Class Action, Class Certification, Fraud, Fraud-on-the-Market

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Stephen Johnson

Proceed with Caution When Foreclosing in Washington State: Split Decisions Regarding Deficiency Claims

Last week, the Washington Court of Appeals, Division One, ruled that, notwithstanding the anti-deficiency provision in the state's Deeds of Trust Act, a lender can pursue a deficiency judgment against a guarantor following a…more

Anti-Deficiency Provisions, Foreclosure, Mortgages

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David Kahn

Florida Legislature Unanimously Approves New Limited Liability Company Act

The Florida Legislature unanimously passed the new Florida Revised Limited Liability Company Act (the "New Act"), and Governor Rick Scott signed the bill into law on June 14, 2013. The New Act is codified as new Chapter 605 of…more

LLC, Operating Agreements, Rick Scott

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Stanley Kaminski

Chicago DOR Expands Lease Transaction Tax

The Chicago personal property lease transaction tax (CTT) is the city's version of a lease or rental tax on personal property. It is an 8 percent tax that applies to any lease or rental of personal property in the city of…more

Department of Revenue, Financial Transaction Tax, Leases, Municipalities

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Alice T. Kane

Report to NAIC on Captives: The Controversy About Principle-Based Reserves and Captives Continues

The use by life insurance companies of captive reinsurance companies to finance XXX and AXXX reserves has been a significant and contentious issue in recent years. Some members of the National Association of Insurance…more

Captive Insurance Company, Life Insurance, NAIC, Reinsurance

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William K. (Ken) Keane

Appeals Court Strikes Down FCC's Net Neutrality Rules

On January 14, 2014, the U.S. Court of Appeals for the District of Columbia Circuit issued a long-awaited decision on the Federal Communications Commission's Open Internet Order. That Order required broadband Internet providers…more

Broadband, Cable Television Providers, Common Carriers, FCC, Internet

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Alan Klein

FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do

On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved Abbreviated…more

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J. Colin Knisely

Banks Previously Sued in Title III ADA Class Action Lawsuits Now Getting Sued Again in Second Wave of Accessibility Lawsuits

A Pittsburgh-based law firm, which has filed more than 100 class action lawsuits under Title III of the Americans with Disability Act (ADA) in federal district courts throughout the United States against banks on behalf of a…more

Accessibility Rules, ADA, ATMs, Banks, Disability

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Lawrence Kotler

U.S. Supreme Court Resolves Circuit Split in Bullock v. BankChampaign, N.A.

One of the primary purposes of bankruptcy is to provide for the discharge of certain debts in order to enable a debtor to obtain a "fresh start" post-bankruptcy. Notwithstanding this specific purpose, section 523 of Title 11 of…more

Debtors, Defalcation Exception, Dischargeable Debts, Embezzlement, Fiduciary Duty

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Hope Krebs

House Ways and Means Committee Releases Proposal on Tax Reform

On February 26, 2014, House Ways and Means Committee Chairman David Camp (R-Mich.) released his plan for U.S. federal tax reform by introducing draft legislation called the "Tax Reform Act of 2014." The proposal is intended to…more

Alternative Minimum Tax, Capital Gains, Corporate Taxes, Medical Devices, Tax Deductions

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James Krieg

Five Ways to Invite (and Avoid) a Malpractice Lawsuit

A recent headline in another leading legal publication asserted: "Malpractice claims are on the rise." As most lawyers know, it is not hard for even legally-aware professionals like themselves to be the defendants in a lawsuit…more

Attorney Malpractice, Career Development, Legal Ethics, Professional Liability

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George Kroculick

Philadelphia Creates Land Bank for City to Sell and Purchase Vacant Property

On January 13, 2014, Philadelphia Mayor Michael Nutter signed into law Bill No. 130156-A, creating a municipal land bank for the city. With this law, Philadelphia became the largest U.S. city to adopt a land bank and joins more…more

Land Bank, Urban Planning & Development

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Meagen Leary

Proceed with Caution When Foreclosing in Washington State: Split Decisions Regarding Deficiency Claims

Last week, the Washington Court of Appeals, Division One, ruled that, notwithstanding the anti-deficiency provision in the state's Deeds of Trust Act, a lender can pursue a deficiency judgment against a guarantor following a…more

Anti-Deficiency Provisions, Foreclosure, Mortgages

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Philip Lebowitz

Refill Reminder Exception to the Privacy Rule Created by the HITECH Act

The passing of the Health Information Technology for Economic and Clinical Health Act (HITECH) resulted in multiple changes regarding existing protection of protected health information (PHI) under the Health Insurance…more

HHS, HIPAA, HIPAA Omnibus Rule, HITECH, OCR

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Mary Beth Lee

IRS's Fresh Start Program: Opportunity to Resolve Unpaid Tax Obligations

Originally published in The Legal Intelligencer on March 15, 2013. Do you have clients, even friends and family, who may be facing serious financial difficulties and may be unable to pay previous or upcoming tax…more

Installment Agreements, IRS, Offers in Compromise, Penalties, Tax Returns

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Nicole Levy

Florida Legislature Unanimously Approves New Limited Liability Company Act

The Florida Legislature unanimously passed the new Florida Revised Limited Liability Company Act (the "New Act"), and Governor Rick Scott signed the bill into law on June 14, 2013. The New Act is codified as new Chapter 605 of…more

LLC, Operating Agreements, Rick Scott

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Kimberly Lippman

Disclosure of Seed Sets: Required to Cooperate or Protected as Attorney Work Product?

The reliability and accuracy of the predictive coding process depends heavily on the identity of the documents in the seed set (including documents deemed irrelevant), because the seed set is the primary source used to teach the…more

Corporate Counsel, Document Productions, Predictive Coding

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Laurie Löben Sels

Sunrise Periods for First Wave of gTLDs Are Now Open

ICANN, the International Corporation for Assigned Names and Numbers, has approved the first wave of generic top-level domains (gTLDs) for release. The introduction of new gTLDs triggers a mandatory 30-day "Sunrise Period" to…more

gTLD, ICANN, Trademark Clearinghouse, Trademarks

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David Loder

Overview of 2013 Amendments to HIPAA Privacy, Security, Breach Notification and Enforcement Rules

On January 17, 2013, the federal Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"), issued the long-anticipated final omnibus amendments (the "2013 Amendments") to the Privacy, Security, Breach…more

Business Associates, Covered Entities, Data Protection, Electronic Medical Records, Enforcement

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Alyson Lotman

"Every Breath" Theory: On Its Last Breaths?

The "every breath," or cumulative exposure opinion, has been proffered by plaintiffs' experts in asbestos cases to prove specific causation, regardless of the type of product or amount of exposure. The U.S. District Court for…more

Asbestos, Asbestos Litigation, Daubert Ruling, Every Breathe Theory, Evidence

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Richard Lowe

Disclosure of Seed Sets: Required to Cooperate or Protected as Attorney Work Product?

The reliability and accuracy of the predictive coding process depends heavily on the identity of the documents in the seed set (including documents deemed irrelevant), because the seed set is the primary source used to teach the…more

Corporate Counsel, Document Productions, Predictive Coding

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Nicholas Lynn

What Amount of Deference, If Any, Is Accorded to CMS' Interpretation of the State Operations Manual?

On May 17, 2013, the United States Court of Appeals for the Fifth Circuit (Court) ruled on a Petition for Review of a Decision of the United States Department of Health and Human Services (DHHS) in the case styled, Elgin Nursing…more

Ambiguous, CMS, Food Safety, Handbooks, HHS

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Wayne Mack

Supreme Court Rejects Stipulation by Proposed Class Representative as Defeating Federal Removal Under Class Action Fairness Act of 2005

In a decision strengthening the ability of defendants in state court class actions to remove those cases to federal court, on March 19, 2013, a unanimous U.S. Supreme Court held in Standard Fire Insurance Company v. Knowles,1…more

Amount in Controversy, CAFA, Class Action, Damages, Jurisdiction

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Michael J. McCalley

Philadelphia's Energy Benchmarking Deadline Will Be at Your Doorstep This Halloween

For owners of commercial buildings of 50,000 square feet or more in the city of Philadelphia, chances are the time has come to address the city's new energy and water use benchmarking law. Energy benchmarking refers to a process…more

Benchmarks, Building Standards, Commercial Property Owners, Energy Efficiency, ENERGY STAR Program

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Hugh T. McCormick

Report to NAIC on Captives: The Controversy About Principle-Based Reserves and Captives Continues

The use by life insurance companies of captive reinsurance companies to finance XXX and AXXX reserves has been a significant and contentious issue in recent years. Some members of the National Association of Insurance…more

Captive Insurance Company, Life Insurance, NAIC, Reinsurance

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Amy McCracken

Seven Tips to Protect Your Facility from a False Claims Act Lawsuit

The False Claims Act is a federal law that imposes liability on persons and companies who make false claims for payment to the federal government. Many states have similar laws. The Act encourages whistleblowers to file suit on…more

False Claims Act, FERA, Internal Investigations, Medicaid, Medicare

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Michael McManus

President Obama Vetoes U.S. International Trade Commission Exclusion Order of Apple Products

For the first time in 26 years, a U.S. president and his administration have exercised statutory authority to veto an exclusion order from the U.S. International Trade Commission (ITC). This development may herald the end of…more

Apple, Exclusions, ITC, Legislative Vetoes, Patents

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Patrick McPherson

Federal Circuit Reverses District Court on Claim Construction in Patent Suit Involving Google's Street View

On March 14, 2014, the U.S. Court of Appeals for the Federal Circuit ruled in a patent appeal case involving Google's Street View technology on a topic in patent law that has received considerable attention recently—claim…more

Claim Construction, Exclusive Jurisdiction, Federal Jurisdiction, Google, Infringement

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Louise Melchor

Revised Common Level Ratio for Philadelphia May Entitle Certain Taxpayers to a Refund

A recent change may affect the parties to certain real estate transactions with respect to property located in Philadelphia County, Pennsylvania, that took place on or after July 1, 2012…more

Common Level Ratio, Fair Market Value, Property Tax, Property Valuation, State Tax Equalization Boards

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Brett Messinger

Revised Common Level Ratio for Philadelphia May Entitle Certain Taxpayers to a Refund

A recent change may affect the parties to certain real estate transactions with respect to property located in Philadelphia County, Pennsylvania, that took place on or after July 1, 2012…more

Common Level Ratio, Fair Market Value, Property Tax, Property Valuation, State Tax Equalization Boards

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Andrew Mishkin

What's Next for Teaming Agreements After Cyberlock?

A recent federal District Court decision holding a teaming agreement between two contractors unenforceable under Virginia law raises questions about the usefulness of these commonly employed agreements—and not just in Virginia…more

Contract Drafting, Contract Interpretation, Contractors, Subcontractors, Teaming Agreements

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Darrick Mix

Guide to Publicly Offered Private Placements Under New Rule 506(c)

Background: A company that needs capital to expand its business or fund its operations often chooses to sell stock or other securities to investors in order to meet its funding requirements. All offerings of stock or…more

Bad Actors, Dodd-Frank, Filing Requirements, Investors, JOBS Act

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Emmy Monahan

State Medicaid Fraud Control Units' Data Mining Likely to Increase Through Federal Funding

On May 17, 2013, the Office of Inspector General, U.S. Department of Health and Human Services (OIG), announced a final regulation that would permit, effective June 17, 2013, state Medicaid fraud control units (MFCU) to use…more

Affordable Care Act, Data Mining, Federal Funding, Fraud, Healthcare

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Kevin Nelson

FDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants

On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies with…more

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George Nemphos

SEC Enforcement Actions Against Private Equity: Get Ready for More

In a speech delivered at the Private Equity International Conference on January 23, 2013, in New York, Bruce Karpati, Chief of the U.S. Securities and Exchange Commission (SEC) Enforcement Division's Assets Management Unit,…more

Asset Management, Asset Valuations, CEOs, CFOs, Conflicts of Interest

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Thomas Newman

Looking Back on Appeals That Made a Difference

Originally published in the New York Law Journal on March 6, 2013. Almost 50 years have elapsed between my first and most recent appearance before the New York Court of Appeals and a recent LEXIS search shows I appeared…more

Appeals, Doctor-Patient Privilege, Drug Treatment, Felony Murder, First Amendment

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Vicki Norton

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug…more

Biologics, Biosimilars, FDA, Notice Requirements, Pharmaceutical

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Ron Oliner

Bitcoin Exchange Mt. Gox Files for Bankruptcy Protection; May Have Broader Implications for Digital Currency Industry

On February 28, 2014, international Bitcoin exchange Mt. Gox filed for bankruptcy protection in Tokyo, capping what is likely the most tumultuous month yet in the history of the controversial virtual currency. Mt. Gox—the…more

Bitcoins, Mt.Gox, Virtual Currency

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Steven Packer

Consider These Tips in Maximizing Your Charitable Tax Deduction

As you gather your tax materials and prepare to file your 2013 tax returns, you may wish to consider whether you have incurred out-of-pocket expenses while serving as a volunteer on behalf of a charitable organization. If so,…more

Charitable Deductions, IRS, Out-of-Pocket Expenses, Tax Returns, Transportation Expenses

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Mary C. Pennisi

Recent Federal False Claims Act Decision Undermines Attorney-Client Privilege over Certain In-House Counsel Emails

A federal magistrate judge's recent decision in United States ex rel. Baklid-Kunz v. Halifax Hospital Medical Center, a Civil False Claims Act (“FCA”) case pending in the United States District Court for the Middle District of…more

Anti-Kickback Statute, Attorney-Client Privilege, Corporate Counsel, False Claims Act, Stark Law

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Jonathan Petrakis

Banks Previously Sued in Title III ADA Class Action Lawsuits Now Getting Sued Again in Second Wave of Accessibility Lawsuits

A Pittsburgh-based law firm, which has filed more than 100 class action lawsuits under Title III of the Americans with Disability Act (ADA) in federal district courts throughout the United States against banks on behalf of a…more

Accessibility Rules, ADA, ATMs, Banks, Disability

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Marvin G. Pickholz

Second Circuit Shifts Burden of Showing Assets to Defendants; Clarifies Monsanto Decision

Both civil and criminal agencies charged with enforcing U.S. laws have turned increasingly to broad based use of "asset freeze orders." Legal counsel and their clients should understand the issue, particularly as there is a…more

Attorney's Fees, Burden-Shifting, Forfeiture, Frozen Assets, Monsanto

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Rachael G. Pontikes

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft…more

Drug Compounding, FDA, FDCA, Fees, Outsourcing

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Elizabeth Powers

Group-Wide Global Insurance Capital Standards First Step - Basic Capital Mandate for G-SIIs

As the first step in the development of group-wide global insurance capital standards, the International Association of Insurance Supervisors (IAIS) released for public consultation its proposal on basic capital requirements…more

Capital Requirements, G-SII, Insurers, International Association of Insurance Supervisors

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Robert L. Pratter

HHS Issues Final Rules on Essential Health Benefits, Federal and Partnership Exchange Qualified Health Plan Accreditation Timeline and Actuarial Value

Essential Health Benefits - On February 20, 2013, the U.S. Department of Health and Human Services (HHS) issued a final rule that set the accreditation standards for qualified health plans (QHPs)—plans that will be…more

Actuarial Values, Affordable Care Act, Essential Health Benefits, Healthcare, HHS

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Robert Prentice

What's Next for Teaming Agreements After Cyberlock?

A recent federal District Court decision holding a teaming agreement between two contractors unenforceable under Virginia law raises questions about the usefulness of these commonly employed agreements—and not just in Virginia…more

Contract Drafting, Contract Interpretation, Contractors, Subcontractors, Teaming Agreements

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Eduardo Ramos-Gómez

Landmark Reform Opens Up Mexico's Energy Sector

On 23 December 2013, the Mexico energy reform bill formally became the law following approval by Mexico's Congress and ratification by a majority of Mexico's state legislatures. This amends Articles 25, 27 and 28 of the…more

Energy, Energy Reform, Mexico, Oil & Gas

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Steven Richman

Automation Systems and Product Liability: Best Practices

Originally published in Law360 on January 25, 2013. Contemporary theater depends increasingly on the "wow" factor. General audiences are no longer satisfied to see a great performance live without an associated visual…more

Automation Systems, Safety Precautions, Safety Training, Warranties

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Bronwyn Roberts

The Applicability of the Massachusetts Wage Act Swells in June 2013

In late June 2013, the Massachusetts Supreme Judicial Court ("SJC") and the Massachusetts Appeals Court (the "Appeals Court") issued two decisions broadly expanding the breadth of the Massachusetts Wage Act (the "Wage Act") by…more

LLC, Penalties, Personal Liability, Wage Act, Wages

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Lida Rodriguez-Taseff

Florida Legislature Unanimously Approves New Limited Liability Company Act

The Florida Legislature unanimously passed the new Florida Revised Limited Liability Company Act (the "New Act"), and Governor Rick Scott signed the bill into law on June 14, 2013. The New Act is codified as new Chapter 605 of…more

LLC, Operating Agreements, Rick Scott

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Paul S. Rosenlund

New Safety Test Requirements for Children's Products Become Effective in February 2013

Manufacturers and importers of children's products, including toys, apparel, sporting goods and jewelry, will soon be subject to yet another safety-testing regulation addressing several vital issues related to such testing: the…more

Consumer Product Safety Improvement Act, CPSC, Manufacturers, Penalties

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Allen Ross

Recent Changes in New York City's Standard Construction Contract

With its new Standard Construction Contract, issued in December 2013, the City of New York (the "City") has implemented numerous significant changes as compared with its 2008 standard contract. This Alert briefly summarizes some…more

Construction Contracts, Construction Disputes, Contract Drafting, Prevailing Wages

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Siegfried Ruppert

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug…more

Biologics, Biosimilars, FDA, Notice Requirements, Pharmaceutical

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K. Oliver Rust

Report to NAIC on Captives: The Controversy About Principle-Based Reserves and Captives Continues

The use by life insurance companies of captive reinsurance companies to finance XXX and AXXX reserves has been a significant and contentious issue in recent years. Some members of the National Association of Insurance…more

Captive Insurance Company, Life Insurance, NAIC, Reinsurance

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Barbara Ruth

Consider These Tips in Maximizing Your Charitable Tax Deduction

As you gather your tax materials and prepare to file your 2013 tax returns, you may wish to consider whether you have incurred out-of-pocket expenses while serving as a volunteer on behalf of a charitable organization. If so,…more

Charitable Deductions, IRS, Out-of-Pocket Expenses, Tax Returns, Transportation Expenses

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Loren Schechter

SEC Targets Investment Adviser Community

The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser…more

Chief Compliance Officers, Compliance, Corporate Counsel, Enforcement, Investment Adviser

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James Schu, Jr.

Bitcoin Exchange Mt. Gox Files for Bankruptcy Protection; May Have Broader Implications for Digital Currency Industry

On February 28, 2014, international Bitcoin exchange Mt. Gox filed for bankruptcy protection in Tokyo, capping what is likely the most tumultuous month yet in the history of the controversial virtual currency. Mt. Gox—the…more

Bitcoins, Mt.Gox, Virtual Currency

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Richard Seabolt

Supreme Court Rejects Stipulation by Proposed Class Representative as Defeating Federal Removal Under Class Action Fairness Act of 2005

In a decision strengthening the ability of defendants in state court class actions to remove those cases to federal court, on March 19, 2013, a unanimous U.S. Supreme Court held in Standard Fire Insurance Company v. Knowles,1…more

Amount in Controversy, CAFA, Class Action, Damages, Jurisdiction

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Stephanie Sgambati

Potential Liability for Wrongful-Birth Claims

On Nov. 14, 2012, in Sernovitz v. Dershaw, 2012 Pa. Super. 248 (Pa. Super. Ct. 2012), the Pennsylvania Superior Court held that 42 Pa.S.C.A. § 8305, which prohibited the tort claims of wrongful birth and wrongful life, was…more

Article III, Wrongful Birth

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Charles Shields

Treasury and IRS Recognize Same-Sex Marriage for All Federal Tax Purposes

On August 29, 2013, the U.S. Department of the Treasury and the Internal Revenue Service (IRS) issued Revenue Ruling 2013-17, declaring that same-sex couples legally married in a jurisdiction that recognizes same-sex marriage…more

DOMA, IRS, Marriage, Same-Sex Marriage, SCOTUS

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Kenneth Shropshire

When Athletes Retire, Is the Next Step Bankruptcy or Paradise?

The "paradise" stories for the post-playing careers of professional athletes are without a doubt under told. The success of Roger Staubach in building a real estate empire, the multiple businesses of NBA all-stars Magic Johnson…more

Athletes, Financial Planning, Retirement, Sports, Tax Planning

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Mark J. Silberman

Legal Briefs - False Claims Act Liability for CRNAs Related to Medical Direction

It has never been a secret to Certified Registered Nurse Anesthetists (CRNAs) that anesthesiologists are often not able to consistently comply with all of the requirements of TEFRA (Tax Equity and Fiscal Responsibility Act of…more

False Claims Act, Healthcare Professionals, Nurses, Professional Liability, Tax Liability

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Richard Silfen

Guide to Publicly Offered Private Placements Under New Rule 506(c)

Background: A company that needs capital to expand its business or fund its operations often chooses to sell stock or other securities to investors in order to meet its funding requirements. All offerings of stock or…more

Bad Actors, Dodd-Frank, Filing Requirements, Investors, JOBS Act

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Harry Silver

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary…more

FCC, FDA, FTC, Healthcare, HHS

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Eric Sinrod

EU Debate over Cybersecurity Laws

We gave a progress report earlier this week in our Alert on the European Commission's plans for wide-ranging changes to data protection laws. It is worth remembering that the European Commission is also considering additional…more

Cybersecurity, EU, EU Data Protection Laws, European Commission

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Brian Slipakoff

Supreme Court Rejects Stipulation by Proposed Class Representative as Defeating Federal Removal Under Class Action Fairness Act of 2005

In a decision strengthening the ability of defendants in state court class actions to remove those cases to federal court, on March 19, 2013, a unanimous U.S. Supreme Court held in Standard Fire Insurance Company v. Knowles,1…more

Amount in Controversy, CAFA, Class Action, Damages, Jurisdiction

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Carla C. Small

Principle-Based Reserves & SPVs: Regulatory Developments

In a Duane Morris Alert dated December 7, 2012, we addressed developments at the fall meeting of the National Association of Insurance Commissioners (NAIC) relating to principle-based reserves (PBR) and the draft White Paper on…more

Federal Insurance Office, NAIC, Principle-Based Reserves, Special Purpose Vehicles

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Christopher Soriano

The Efforts to Legalize Sports Betting in New Jersey—A History

A complex and expensive battle between the National Collegiate Athletic Association (NCAA) and the four major professional sports leagues and the state of New Jersey over whether New Jersey’s casinos and racetracks can offer…more

Amended Legislation, NCAA, PASPA, Sports, Sports Betting

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Andrew Sperl

Supreme Court Holds FDCA Preempts Common Law Design-Defect Claim Against Generic Drugs

On June 24, 2013, the U.S. Supreme Court held in Mutual Pharmaceutical Co., Inc. v. Bartlett that the Federal Food, Drug, and Cosmetic Act (FDCA) preempted the respondent's common law claim for damages arising from the alleged…more

Design Defects, Drugs, FDA, FDCA, Generic Drugs

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Carolyn Sprinchorn

Marketplace Fairness Act of 2013 Passes United States Senate

On May 6, 2013, the United States Senate passed the Marketplace Fairness Act of 2013 (the "Act") by a vote of 69 to 27. The legislation (S. 743) now moves to the House of Representatives for consideration…more

Due Process, Equal Protection, Internet Retailers, Marketplace Fairness Act, Proposed Legislation

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Jeffrey Sternklar

The Applicability of the Massachusetts Wage Act Swells in June 2013

In late June 2013, the Massachusetts Supreme Judicial Court ("SJC") and the Massachusetts Appeals Court (the "Appeals Court") issued two decisions broadly expanding the breadth of the Massachusetts Wage Act (the "Wage Act") by…more

LLC, Penalties, Personal Liability, Wage Act, Wages

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David Sussman

House Ways and Means Committee Releases Proposal on Tax Reform

On February 26, 2014, House Ways and Means Committee Chairman David Camp (R-Mich.) released his plan for U.S. federal tax reform by introducing draft legislation called the "Tax Reform Act of 2014." The proposal is intended to…more

Alternative Minimum Tax, Capital Gains, Corporate Taxes, Medical Devices, Tax Deductions

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Rodney Sweetland III

Federal Circuit Reverses District Court on Claim Construction in Patent Suit Involving Google's Street View

On March 14, 2014, the U.S. Court of Appeals for the Federal Circuit ruled in a patent appeal case involving Google's Street View technology on a topic in patent law that has received considerable attention recently—claim…more

Claim Construction, Exclusive Jurisdiction, Federal Jurisdiction, Google, Infringement

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Michael A. Swit

FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do

On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved Abbreviated…more

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Charlotte Thomas

Grimes: Another Look at Reliance and Loss Under Pa.'s UTPCPL

The Pennsylvania Supreme Court is taking another look at justifiable reliance and "ascertainable loss" under Pennsylvania's Unfair Trade Practices and Consumer Protection Law (UTPCPL). On Jan. 30, the court granted allocatur in…more

Breach of Contract, Fraud, Litigation Fees & Costs, Unfair or Deceptive Trade Practices

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Dmitry Tuchinsky

WellPoint Pays HHS $1.7 Million to Settle HIPAA Security Violations

Covered Entities Cautioned Regarding Use of Business Associates - On July 8, 2013, health insurer WellPoint, Inc. entered into a Resolution Agreement with the U.S. Department of Health and Human Services, Office for Civil…more

HHS, HIPAA, Policy Violations, Settlement, WellPoint

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Driscoll Ugarte

Florida Legislature Unanimously Approves New Limited Liability Company Act

The Florida Legislature unanimously passed the new Florida Revised Limited Liability Company Act (the "New Act"), and Governor Rick Scott signed the bill into law on June 14, 2013. The New Act is codified as new Chapter 605 of…more

LLC, Operating Agreements, Rick Scott

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James Vincequerra

Second Circuit Ruling Appears to Limit Ability of U.S. Bankruptcy Courts to Assist Foreign Debtors

In Drawbridge Special Opportunities Fund LP v. Barnet (In re Barnet), Case No. 13-612, 2013 WL 6482499 (2d Cir. Dec. 11, 2013), the United States Court of Appeals for the Second Circuit held that in order for a foreign…more

Chapter 15, Commercial Bankruptcy, Debtors, Foreign Nationals

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Mark Walsh

Fifth Circuit to Dodd-Frank Whistleblowers: Call the SEC First

The U.S. Court of Appeals for the Fifth Circuit's decision last week in Asadi v. G.E. Energy (USA) has been hailed as a win for employers because it requires whistleblowers who bring retaliation claims under the Dodd–Frank Wall…more

Adverse Employment Action, Dodd-Frank, Retaliation, SEC, Whistleblower Protection Policies

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Thomas Wechter

Rollovers as Business Startups: A Guide to Using Retirement Funds to Start a Business

Over the past 10 years, thousands of entrepreneurs have used their existing retirement savings held by a qualified retirement plan or IRA to finance the startup or acquisition of a new business. According to industry experts in…more

401k, Business Formation, Entrepreneurs, IRA, Retirement

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James Welch

Disclosure of Seed Sets: Required to Cooperate or Protected as Attorney Work Product?

The reliability and accuracy of the predictive coding process depends heavily on the identity of the documents in the seed set (including documents deemed irrelevant), because the seed set is the primary source used to teach the…more

Corporate Counsel, Document Productions, Predictive Coding

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Jenny Wheater

UK Budget Speech - Key Points

The UK's Chancellor of the Exchequer, George Osborne, delivered his annual Budget Speech on 19 March 2014. More details of measures announced will be known when a new draft of the Finance Bill 2014 is published on 27 March. A…more

Economic Development, Tax Reform, UK

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Keli Whitlock

The One Mistake Startup Entrepreneurs Always Make - A Legal Perspective...

In your experience working with startup entrepreneurs, what's the one mistake they make time and again? The answer to that question of course varies greatly, depending on whom you ask - and, for legal perspective, we put…more

Business Formation, Legal Perspectives, Shareholders' Agreements, Startups

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Jerome Wolf

Home Is Where You Hang Your Hat: The Significance of Domicile Planning

A debtor, regardless of state residence, can seek protection from his or her creditors in the federal bankruptcy courts. However, the state in which the debtor resides or, more accurately, is "domiciled," will determine which…more

Debtors, Domicile, Estate-Tax Exemption, Exempt Assets, Financial Planning

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Mauro Wolfe

SEC Targets Investment Adviser Community

The Enforcement Division of the Securities and Exchange Commission (SEC) and its Office of Compliance Inspections and Examinations (OCIE) are focusing their examination and disciplinary efforts on the investment adviser…more

Chief Compliance Officers, Compliance, Corporate Counsel, Enforcement, Investment Adviser

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