Archives: Focus Areas

When an organization agrees to settle civil or criminal charges with a government regulator, it is likely that the organization will be required to retain an “integrity monitor” to ensure compliance with the terms of its agreement. Such agreements frequently mandate the implementation of compliance programs, remedial measures and reforms of various kinds. In the health care industry, these integrity monitors are frequently Independent Review Organizations (IRO) that are mandated by Corporate Integrity Agreements (CIA). Integrity monitors are also frequently utilized on major public works projects to ensure probity in the performance of government contracts, either as part of a proactive effort to minimize waste and abuse, or because the contractor or its employees were previously investigated or charged with misconduct. Our attorneys are experienced and well-positioned to assist in this area, either as an integrity monitor or as a shadow advisor to an organization required to accept such a monitor. In the health care context, we can assist organizations operating under a CIA to ensure that the organization’s compliance program is operating correctly and that all obligations under the CIA are being discharged properly. We can help anticipate and address compliance risks before they come to the attention of regulators, assist the organization with its annual reporting obligations, and where appropriate or necessary, mediate disputes between the organization and regulators or the IRO assigned to perform compliance reviews.

We possess the expertise necessary to help businesses comply with federal regulations governing the food, dietary supplement/nutraceutical, cosmetics and natural products industries. With a deep knowledge and understanding of the regulatory scheme, we navigate our clients through the myriad of regulations their businesses must deal with daily. Our attorneys are intimately familiar with key players at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and the Division of Dietary Supplement Programs. Our vast experience – from the safety and efficacy of new ingredients for use in dietary supplements (New Dietary Ingredients/NDI) and conventional foods (Generally Recognized as Safe/GRAS), to basic operational considerations under current Good Manufacturing Practices (cGMP), to the creation of compliant, accurate, product labels and labeling – has proven rewarding for clients dealing with compliance issues.

For manufacturers, importers, or distributors of OTC drugs, cosmetics and natural products (foods and dietary supplements) located throughout the United States and internationally, an FDA inspection can be a difficult, sometimes traumatic experience that often triggers a series of events that could have serious consequences for their businesses. Our attorneys possess the knowledge and experience to assist in the defense of FDA inspections and respond to an FDA Form 483 (Report of Inspectional Observations), Warning Letter, Notice of Detention, Import Alert or even a threatened seizure or injunction that could force a company to shut its doors absent a well-thought-out response and defense. With our hands-on experience, preparation, and access to all of the resources needed to protect a company facing regulatory challenges, we can help ensure that you are doing everything possible to protect your business.

We can assist clients in responding to and defending against government investigations of all kinds, including inquiries by the U.S. Department of Justice, Department of Health and Human Services, Office of Inspector General, Centers for Medicare and Medicaid Services, Fiscal Intermediaries, Program Integrity Contractors, FDA, Medicaid Fraud Control Units, and state attorney general offices. These investigations may involve allegations of fraud,  improper medical and/or insurance company billing, “off-label” marketing or other drug/device misbranding or adulteration, illegal kickbacks, violations of the Stark self-referral law, HIPAA privacy violations, wrongdoing during clinical research, violations of the Prescription Drug Marketing Act, or other misconduct. Such investigations frequently involve both civil and criminal components, might span multiple years and require the review and production of hundreds of thousands of documents, and can be a financial and reputational drain on a company. Where appropriate, we can assist clients in attempting to resolve these investigations early enough in the process to mitigate these harms, with the aim of achieving a favorable settlement, or even obtaining a finding of no liability. If an early resolution cannot be reached, our experienced attorneys stand ready to litigate.

We have assisted clients in the natural and conventional food, cosmetics and dietary supplement/nutraceutical industries, as well as other industries, conduct advertising reviews for compliance with Federal Trade Commission (FTC) substantiation standards.  In recent years, the FTC has shown a new aggressiveness in challenging claims made by advertisers in all media – be it print, television, radio, or even social media such as Twitter, Facebook, or Instagram.  With our years of experience, we can work with our clients to identify potential problems and guide them through the process necessary to ensure that they are substantiated by “competent and reliable evidence accepted by experts in the field” – the standard applied by the FTC and state attorneys general across all fields of advertising.

We also have the skills to assist with responses to FTC access letters or civil investigative demands, state attorney general investigations, class action complaints, competitors’ challenges lodged with the National Advertising Division of the Better Business Bureaus (NAD), as well as unfair competition/Lanham Act challenges to advertising. These same skills are used to help our clients respond to unfair advertising practices by their competitors through the preparation and filing of challenges with the NAD or in federal and state courts.

With decades of experience, Rivkin Radler’s General Liability lawyers represent owners and operators of sports and entertainment facilities in claims involving patron accidents, assaults, and other security-related issues.  We have successfully represented some of the largest venues in the metropolitan area, including Barclays Center, Madison Square Garden, and Chelsea Piers.

We have vast experience representing clients before the Internal Revenue Service (IRS) and state taxing authorities and, when necessary, have defended clients all the way to the U.S. Tax Court or the New York State Tax Appeals Tribunal. We have a successful track record in obtaining favorable private letter rulings (PLRs) for clients who have failed to make certain regulatory elections. For example, we recently secured a ruling that entitled our client to file an amended estate tax return and deduct an additional $675,000, resulting in over $300,000 of tax savings.

Acting as a fiduciary brings significant responsibility. Our lawyers represent individual and corporate executors and trustees throughout the difficult process of administering a loved one’s estate.  We provide all of the services a fiduciary will need to take an estate through probate or for the administration of a trust. This includes preparing and filing all necessary documents, filing an accounting, and making the final distribution to the beneficiaries. Our legal team regularly assists clients on a wide range of issues such as navigating the court system, marshalling assets in multiple jurisdictions, planning for post-mortem tax situations, and managing family expectations.

The attorneys in our Trusts & Estates Practice Group have substantial experience in preparing and presenting petitions seeking to establish a guardianship and in defending individuals who do not believe a guardianship is necessary.

We also counsel families with disabled or other special needs individuals and understand the challenges involved. The day-to-day demands of caring for a child with special needs can be overwhelming. Often lost is the need to plan for when you can’t be there. Depending on your child’s particular needs, it can be quite costly to provide for his or her long-term care.

Our attorneys handle all aspects of special needs planning including the creation of Special Needs Trusts and Letters of Intent. We deal with governmental or other alternative programs to maximize the quality of care and services that are available to children and others who face special challenges.

We recommend meeting with us before your child turns 18, at which point you may no longer be able to gain access to your child’s medical, educational, legal and financial records unless you have put a plan in place to do so.

There are several planning tools available:

• Special Needs Trusts
• Supplemental Needs Trusts
• Special Needs Guardianships (Article 17-A)
• Article 81 Guardianships
• Medicaid Planning

We can also help with selecting the appropriate benefits – Social Security Disability Insurance, Medicaid, Medicare and more – and help determine which services your child will need throughout his or her lifetime.

At Rivkin Radler, we always seek to minimize litigation to the extent possible. However, when disputes arise that cannot be resolved informally, our attorneys vigorously advocate for our clients’ rights in all phases of estate and trust litigation. With decades of litigation experience, we are thoroughly familiar with the unique nuances of Surrogate’s Court practice. We represent fiduciaries, beneficiaries and heirs in contested probate proceedings, including will contests, contested accountings and proceedings to remove fiduciaries. We defend fiduciaries when a beneficiary has challenged the manner in which they have executed their duties. We also protect beneficiaries’ rights from the acts or omissions of negligent fiduciaries.

Before any planning begins, our trusts and estates lawyers help our clients evaluate their unique circumstances, both personal and financial, and the individual goals they want to achieve. We then create a balanced estate plan that is tailored to each client’s individual needs. For some, this can be as simple as a will or living trust that passes everything to a spouse or children. For others, the process is more complex as we integrate sophisticated tax planning into the personal estate plan.

We take an active approach in preserving each client’s wealth by developing innovative plans that minimize income, gift, estate and generation-skipping transfer taxes and by structuring plans based on income tax consequences.

Throughout the estate planning process, we remain mindful of the difficulties in parting with assets during life and strive to help ease this concern so that each client can achieve tax benefits while still provide for personal concerns. Some tools and techniques often used for our clients:

• Defective Grantor Trusts
• Non-Grantor Irrevocable Trusts
• Irrevocable Life Insurance Trusts (ILITs)
• Grantor Retained Annuity Trusts (GRATs)
• Charitable Remainder Trusts (CRTs)
• Charitable Lead Trusts (CLTs)
• §2503(c) Minors Trusts
• Supplemental Needs Trusts (SNTs)
• Revocable Living Trusts
• Spousal Limited Access Trusts (SLATs)
• Qualified Personal Residence Trusts (QPRTs)
• Family Limited Partnerships and LLCs
• Private Foundations
• Installment Sales

When a charitable entity is created, our focus shifts from personal planning to organizational representation. Forming and administering a charitable entity requires great detail to tax, regulatory, and other state law requirements. We also are proficient in preparing gift tax returns.