Foley Hoag LLP

SUMMARY

Excerpt:

Q: Has the current economic crisis altered the regulatory environment? If so, how?

A: The current economic crisis has altered the regulatory environment in two important and related respects.

First, the law has changed. Congress enacted the Emergency Economic Stabilization Act of 2008 (“EESA”), which requires all federal financial regulatory agencies to cooperate with the Federal Bureau of Investigation (“FBI”) and all “other law enforcement agencies,” including state regulatory agencies, that are “investigating fraud, misrepresentation, and malfeasance with respect to development, advertising, and sale of financial products.” As a practical matter, this requires financial regulatory agencies, such as the Securities and Exchange Commission (“SEC”) and Financial Industry Regulatory Authority (“FINRA,” formerly the NYSE), to provide support to the FBI’s and state law enforcement’s criminal investigations of financial fraud. As a result of this broad mandate, more criminal investigations concerning the current economic crisis should be expected. The EESA also creates new civil liabilities (e.g., for misrepresenting or falsely advertising the insured status of bank deposits) and new disclosure obligations (e.g., for those financial institutions participating in the Troubled Asset Relief Program (“TARP”)).

Second, the climate has also changed. The public desire to assign blame for the financial crisis and the attendant political pressure to prosecute entities or individuals who may be responsible will likely lead to more vigorous enforcement of familiar criminal laws and financial regulations, such as prohibitions on securities fraud and insider trading as well as wire, mail, bank and bankruptcy fraud. In addition, pending investigations may lead to high-profile prosecutions that press novel theories under more general laws, such as New York’s Martin Act. For example, New York Attorney General Andrew Cuomo is currently investigating executive compensation and corporate spending at major financial institutions that have received federal bailout funds, and he has threatened to “seek appropriate sanctions and remedies” against any company that “wastes” taxpayer funds—for example, by deeming employee bonuses to be fraudulent conveyances in violation of New York law. Massachusetts Secretary of State William Galvin has already charged investment banks with violating state securities laws by defrauding investors who purchased collateralized debt obligations and auction rate securities.

Other questions include: 

• Which government agencies are investigating activities relevant to the current economic crisis? And who is under investigation?
• What types of activities will investigators be looking at? Can you give some examples?
• What steps should we take if our company receives the proverbial “knock on the door”?
• Our best client/joint venture partner is under investigation. What steps should our company take?

SUMMARY

We know that the recent financial crisis and related economic downturn unfortunately are causing many employers to consider ways to reduce operational expenses, including through workforce restructuring and layoffs. We offer a few preliminary considerations: any such reduction-in-force (RIF) must be carefully planned and executed both to minimize exposure to liability under various employment laws and to mitigate negative effects on employee morale and operations. The following are some issues for employers to consider as they grapple with whether and how to implement a layoff.

Questions Include:

• Is a Layoff Necessary?
• Voluntary or Involuntary Program?
• Develop Uniform Selection Criteria
• Conduct a Layoff Analysis
• Is Advance Notice Required
• Severance and ERISA
• Asking for a Release
• Don't Forget Immigration Implications
• Don't Lose Sight of Termination Basics

SUMMARY

On Wednesday, October 22, 2008, the Federal Trade Commission issued an Enforcement Policy Statement that it will delay some elements of enforcement of recent “Red Flags” regulations until May 1, 2009, instead of the original November 1, 2008 date.

SUMMARY

Foley Hoag LLP’s interdisciplinary team counsels and protects the interests of its clients facing new realities, challenges and risks framed by today’s tumultuous economic and market conditions. By maintaining an active and engaged dialogue with our clients during this period of economic distress, our lawyers are better able to adapt to the changing legal needs of clients affected in the short term. More importantly, our immersion in their businesses and industries enables our lawyers to provide sound, strategic counsel to protect our clients’ interests in the longer term. The Economic Crisis Team delivers forward-thinking advice, focusing on long-standing core, integrated strengths of the firm.

Topics include:

• Financial investigations, enforcement proceedings and litigation
• Federal and state securities regulation
• Deal-making, corporate finance and investment restructuring
• Bankruptcy, corporate reorganization and financial disputes

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In a decision that will have far reaching implications for drug and medical device development, the Court of Appeals for the Federal Circuit held yesterday that the Hatch-Waxman safe harbor of 35 U.S.C. § 271(e)(1) is inapplicable to patented research tools that are not themselves subject to the FDA review process. While the decision is good news for the providers of research tools such as drug screening assays, it will make drug and medical device development in the United States costlier and more risky.

SUMMARY

Global Bio-Chem Technology Group Company Limited (GBT), a Chinese biotechnology company, has prevailed in a patent litigation brought by Ajinomoto Co., Inc in the International Trade Commission.

A Foley Hoag patent litigation team, including Claire Laporte, DeAnn Smith, and Jeremy Younkin, invalidated the asserted claims of two US patents. The Administrative Law Judge of the International Trade Commission also found both patents unenforceable because Ajinomoto committed inequitable conduct.

The decision represents an important victory for the Chinese biotechnology industry. Li Weigang, Assistant General Manager of GBT, said, "We are pleased that the Administrative Law Judge has determined there was no violation of Section 337. This ruling maintains continued competition in the marketplace, which will benefit American consumers during this time of rising food prices."

The Washington, DC firm Adduci, Mastriani & Schaumberg LLP are co-counsel with Foley Hoag LLP. 

The full Press Release is available here.

SUMMARY

Contents

1. Exposure to Liability in the Hiring Process

2. Failure to Adequately Document Terms and Conditions of Employment

3. Misclassification Issues
    - Employee or Independent Contractor
    - Exempt or Non-exempt

4. Failure to Comply with Wage Payment Laws

5. Inadequate Protection of Intellectual Property

SUMMARY

According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which includes biotechnology and medical devices, accounted for 28% of VC money invested, the largest investment sector in 2006.

As Life Sciences venture capital investing has risen, the biotechnology industry has become increasingly dependent on such funding. This is particularly true for start-up companies that cannot rely on revenue from marketed biologics to fund their research and development pipeline. To cover the nearly $1 billion capital investment required to bring a biologic drug to market (from discovery through clinical trials and FDA approval), early-stage companies rely on VC investing. Investing in emerging companies, however, is risky for a venture capitalist: only 1 in 10 drugs discovered actually makes it to market, and despite the more than $50 billion spent on biotech drugs in 2006, the great majority of early-stage companies never reach the point of net profitability.

SUMMARY

On June 16, 2008, Massachusetts Governor Deval Patrick signed into law legislation (.pdf) that provides a total of $1 billion over the next ten years to support the development of the life sciences industry in Massachusetts. The legislation, commonly known as the Life Sciences Initiative (LSI), is designed to stimulate research, development, manufacturing, and commercialization in the life sciences sector and, ultimately, to increase employment and associated tax revenues. To achieve these goals, the LSI significantly expands the activities of the recently created Massachusetts Life Sciences Center (LSC) by dramatically increasing the funding available for capital expenditures, grant programs and other incentives. The LSI also establishes an aggressive set of tax incentives that include a broad array of refundable and other types of tax credits. 

SUMMARY

Established in December 1980 by the partners of law firm Foley Hoag, The Foley Hoag Foundation is a private foundation that seeks to combat racism, especially among youth, in the City of Boston. The Foundation awards grants to organizations working to improve the racial climate in Boston by addressing issues of diversity and racism. Grantee organizations achieve their goals through a variety of means, including arts and cultural activities, youth leadership and recreational programs. Other grantees provide advocacy assistance, enabling individuals to confront racism through legal or political action. Some grantee organizations work to prepare young children to live in the reality of a multicultural society, others engage teens, and a few target a primarily adult constituency.

The Foley Hoag Foundation was the first—and remains the only— foundation to focus exclusively on the improvement of race relations in Boston. The trustees are fortunate to have the unqualified endorsement of Foley Hoag, which has provided an enormous amount of financial, administrative and moral support.

SUMMARY

Despite the fact that securities fraud lawsuits involving auditors are said to be relatively few in number as a percentage of total new filings and new filings are below the historical average, auditors often come to be added as defendants, particularly in high-profile cases.1 In the past few years, for example, auditors have been named as parties in the five proceedings with the largest total dollar value settlements to date -- Enron, WorldCom, Cendant, Tyco and AOL Time Warner -- and in several other well-known actions including Global Crossing, Parmalat and Delphi. With the majority of all cases historically alleging accounting irregularities and over 90% of last year’s filings reportedly containing alleged misrepresentations in financial documents, suits against auditors are never far off.

This article reviews first the role of the auditor and reminds counsel of the benefits of understanding and educating the court regarding the role of the auditor, namely that the auditor does not prepare a company’s financial statements; rather, the auditor opines on the fair presentation of management’s financial representations based on the auditor’s testing those representations. This article then surveys three areas of law germane in suits against auditors: (1) scienter requirements with respect to auditors; (2) the scope of primary liability and “scheme” liability with respect to auditors; and (3) “one firm” theories asserted against international audit firms.

SUMMARY

Yesterday, the U.S. Environmental Protection Agency published its long-anticipated formal determination on California's request to waive federal preemption of its automobile emissions standards for greenhouse gas emissions ("GHGs"). Although the ultimate fate of the EPA's determination will almost certainly be decided by the courts, the dispute between California and the EPA highlights the tension between state and federal efforts to regulate GHGs.

SUMMARY

On February 20, in an 8-1 decision, the United States Supreme Court held that state common law tort claims against medical device manufacturers are preempted by FDA’s approval under the Premarket Approval (PMA) process. The decision dramatically enhances the regulatory compliance defense for Class III medical devices that receive Premarket Approval (PMA) from the Food and Drug Administration (FDA).

SUMMARY

• In Stoneridge, the Supreme Court ruled that businesses may not be sued in private securities fraud lawsuits unless they themselves make deceptive statements or acts directly relied on by investors.

• The Court sought to shield parties in "the realm of ordinary business operations" who do not attempt to "affect securities markets" from the risks and costs associated with private shareholder litigation.

• The SEC and Justice Department may still proceed against businesses that participate in fraudulent schemes or otherwise "aid and abet" fraud.

SUMMARY

Succeeding in today’s highly-complex marketplace requires paying particular attention to labor and employment issues. Our long-standing strength in representing employers in labor relations and employment litigation defense issues is complemented by our experience in dealing with the emerging issues confronting employers in the 21st century.

Our goal is to provide pragmatic business advice and a cost-effective approach aimed at helping you achieve results.

We handle a wide variety of issues facing our clients each day. Some of these matters include:

• Attempts to seek class-wide relief in wage-and-hour and other actions
• Efforts by unions to obtain neutrality and card-check agreements
• Increased efforts to control employment litigation costs through alternative dispute resolution, particularly arbitration
• Enforcement of non-competition agreements and protection of trade secrets
• Sarbanes-Oxley investigations
• Claims for stock options and other employment benefits
• Providing advice on numerous issues arising from the National Labor Relations Act and various state labor law
• Assisting clients in collective bargaining matters
• Representing employers before the National Labor Relations Board
• Handling grievance and interest arbitrations arising under collective bargaining agreements
• Helping employers preserve their non-union status in the face of organizing campaigns
• Assisting employers in obtaining the appropriate bargaining units during a union election

SUMMARY

Successful dispute resolution requires perspective, from all vantage points. At Foley Hoag, we offer you clear insight into when to go to the mat and when to settle. If litigation becomes necessary, we focus on helping you make prudent upfront decisions that best represent your interests and aim to reach a prompt, cost-effective and viable solution.

SUMMARY

Engagements Include:

• Litigation and Arbitration between Sovereign States
• Arbitration between Sovereign States and Investors
• International Commercial Arbitration
• Litigation before the United States Courts

SUMMARY

• Litigios y Arbitrajes entre Estados Soberanos
• Arbitrajes entre Estados
• Soberanos e Inversionistas
• Arbitrajes Internacionales Comerciales
• Litigios ante las Cortes de los Estados Unidos

SUMMARY

Drug company scientists discover that a rare debilitating disease may be treated with a drug licensed to treat an unrelated ailment. The Food and Drug Administration (“FDA”) has not approved the drug for the rare disease. While the company begins time consuming and expensive clinical trials to test this discovery, patients with the rare disease ask their doctor for the drug. Doctors seek as much information as possible on this “off-label” use. The drug company wants to get the word out quickly about the new use.

• Should a drug company be permitted to promote the drug for the new use before FDA approval, and if so, what can the company say?
• Should doctors be permitted to prescribe a drug for an unapproved use, and if so, under what conditions?
• If doctors can prescribe the drug, how do they obtain information on the correct dosage and adverse side effects?
• Under what circumstances can a company provide “off-label” information to doctors?

Download A Low Dose Prescription: Criminal Prosecution of Off-Label Drug Promotion (.pdf)

SUMMARY

This chapter includes the following topics:

• Strategy, objectives and preliminary considerations
• Formal reactions to incivility
• General incivility
• Incivility throughout discovery
• Incivility during depositions
• Incivility in court
• Checklist: considering whether to seek attention of court
• Checklist: addressing general incivility
• Checklist: addressing incivility throughout discovery
• Checklist: addressing incivility in depositions
• Checklist: addressing incivility in court

Reprinted with permission from:
Business and Commercial Litigation in Federal Courts
Section of Litigation I American Bar Association
Second edition