Thursday, June 11, 2015
The Government Accountability Office (GAO) released a report dated May, 2015 on Retirement Security: Most Households Approaching Retirement Have Low Savings. The 51 page report is available here. The GAO offered this summary:
Many retirees and workers approaching retirement have limited financial resources. About half of households age 55 and older have no retirement savings (such as in a 401(k) plan or an IRA). According to GAO's analysis of the 2013 Survey of Consumer Finances, many older households without retirement savings have few other resources, such as a defined benefit (DB) plan or nonretirement savings, to draw on in retirement (see figure below). For example, among households age 55 and older, about 29 percent have neither retirement savings nor a DB plan, which typically provides a monthly payment for life. Households that have retirement savings generally have other resources to draw on, such as non-retirement savings and DB plans. Among those with some retirement savings, the median amount of those savings is about $104,000 for households age 55-64 and $148,000 for households age 65-74, equivalent to an inflation-protected annuity of $310 and $649 per month, respectively. Social Security provides most of the income for about half of households age 65 and older...
Studies and surveys GAO reviewed provide mixed evidence about the adequacy of retirement savings. Studies range widely in their conclusions about the degree to which Americans are likely to maintain their pre-retirement standard of living in retirement, largely because of different assumptions about how much income this goal requires. The studies generally found about one-third to two-thirds of workers are at risk of falling short of this target. In surveys, compared to current retirees, workers age 55 and older expect to retire later and a higher percentage plan to work during retirement. However, one survey found that about half of retirees said they retired earlier than planned due to health problems, changes at their workplace, or other factors, suggesting that many workers may be overestimating their future retirement income and savings. Surveys have also found that people age 55-64 are less confident about their finances in retirement than those who are age 65 or older
Highlights of the GAO report are available here.
Tuesday, June 9, 2015
A recent article from the Washington Post focused on an important topic, whether aging comes naturally to us. I don't mean physiologically, because as we all know, we age without any conscious effort on our parts. Instead, Aging doesn’t always come naturally. Classes are teaching boomers how. focuses on a program on how to age successfully. Is there a need for a program to tell us how to do well something that just seems to happen? "[B]oomers tend to see themselves as forever young and have sometimes been reluctant to embrace the last stage of life with the same gusto as their youthful activism, said Lylie Fisher, director of community development at Iona" (a non-profit that runs the programs). Iona offers a Take Charge/Age Well academy which according to the website, teaches students "how to navigate the opportunities and challenges of aging through presentations from Iona’s aging-in-place specialists. The specialists offer expert advice, wellness coaching, guidance on critical decision-making, and information on planning for the future. " The Post article also mentions co-housing, which is covered in one of the programs.
Check out the article, as well as the program's website. Very interesting!
On June 5, 2015, the Attorney General for Pennsylvania announced filing of a civil suit, seeking permanent injunctive relief against a lawyer and his law firm, for tactics alleged to violate state unfair trade practice and debt collection laws. The allegations include misuse of Pennsylvania's filial support law to demand payment by family members for medical service fees incurred by the original debtor. Here is the link to the AG's press release.
Boy, it's been a tough month already for Pennsylvania debt collectors! The AG's suit is not against the same law firm involved in the Second Circuit's decision reported here earlier this week.
Monday, June 8, 2015
In Eades v. Kennedy PC Law Offices, decided June 4, 2015, the Second Circuit ruled that a federal court in New York has personal jurisdiction to address alleged unfair debt collection practices of a Pennsylvania law firm in seeking to collect unpaid nursing home fees totaling $8,000. The plaintiffs, New York residents -- the husband and adult daughter of a woman in a Pennsylvania nursing home -- challenged statements in correspondence and phone communications allegedly made by the Pennsylvania law firm. The claims against the daughter were based on Pennsylvania's filial support law.
As reported on this Blog in December 2013, the United States District Court for the Western District of New York dismissed the suit, finding no personal jurisdiction and further rejecting application of the federal Fair Debt Collection Practices Act (FDCPA). The Second Circuit's ruling concludes, however, that the law firm's "three purposeful contacts with New York," of mailing a debt collection notice to the New York family members, engaging in a debt collection phone call with the daughter, and mailing a summons and complaint to both the daughter and the nursing home resident's husband, are enough to establish personal jurisdiction under New York's long-arm statute. Further, the defendant law firm had not shown that exercise of such jurisdiction was unreasonable.
On the questions raised by the FDCPA claims, the Second Circuit rejected several key arguments by the plaintiffs, concluding that Pennsylvania's filial support law is not preempted by the Nursing Home Reform Act's prohibition on nursing homes requiring third party guarantees of payment:
June 8, 2015 in Consumer Information, Ethical Issues, Federal Cases, Federal Statutes/Regulations, Health Care/Long Term Care, Legal Practice/Practice Management, State Cases, State Statutes/Regulations | Permalink | Comments (0)
Sunday, June 7, 2015
Thursday, June 4, 2015
PBS did a story that is compelling. Number of seniors threatened by hunger has doubled since 2001, and it’s going to get worse offers that "[n]early one in six senior citizens face the threat of hunger in the United States. Charity and food stamps reach some of these vulnerable Americans, but limited resources and isolation mean many are struggling without receiving help." The audio of the story as well as a transcript is available here. The story reviews the importance of social service programs, which may be hampered by long wait lists, food banks and more that provide some assistance. As I mentioned, this is a compelling story. It's also sad. Thanks to my colleague, Professor James Fox, for sending me the link to the story.
Monday, June 1, 2015
The Florida Joint Public Policy Task Force for the Aged and Disabled urges individuals, families and attorneys to bring emerging problems with Medicaid Managed Care in Florida to the attention of administrators at the Agency for Health Care Administration (AHCA). Only by staying on top of any problems can the new systems be evaluated and corrected.
In the Florida Bar News, the Task Force writes:
One issue the Task Force — a combined effort of the Academy of Florida Elder Law Attorneys and The Florida Bar’s Elder Law Section — is concerned about is that seniors on Medicaid may be signing forms allowing their Medicaid managed care plans (MCP) to take control over who receives information from the state, including notices for annual deadlines for ongoing eligibility, without understanding what they are signing. This led to an MCP missing the deadline for at least one client.
“A wife was understandably very upset when she found out her husband’s Medicaid had been cancelled,” says Emma Hemness, the president of the Academy of Florida Elder Law Attorneys, Task Force member and elder law attorney in Brandon. “The MCPs are supposed to make sure this doesn’t happen. The wife says she never received a notice and she doesn’t remember giving any authority to the MCP.
Sunday, May 31, 2015
The GAO has issued a new report on how Home & Community Based Services & Supports are delivered. Older Adults Federal Strategy Needed to Help Ensure Efficient and Effective Delivery of Home and Community-Based Services and Supports is a 60 page report that "addresses (1) federal programs that fund these services and supports for older adults, (2) how these services and supports are planned and delivered in selected localities, and (3) agencies’ efforts to promote a coordinated federal system of these services and supports." The GAO recommends in the report "that HHS facilitate development of a cross agency federal strategy to ensure efficient and effective use of federal resources for HCBS. HHS concurred and HUD, DOT, and USDA did not comment." A number of topics are covered, including transportation, aging in place, information and referral, housing, in-home services, and food assistance. The report discusses the importance of cross-agency collaboration. The GAO concludes that
As the older population continues to grow, communities will find it increasingly difficult to meet the demand for the HCBS and supports many older adults will need to age in their own homes and communities. Based on recent trends, federal funding at AoA, HUD, and DOT for HCBS and supports is not likely to keep pace with demand for these services and supports, making it important to ensure that the federal resources available for this purpose are used effectively and efficiently. Development of a cross-agency federal strategy could better position the federal agencies to assist area agencies on aging and community-based organizations with providing HCBS and supports in the most efficient and effective manner. Under the Older Americans Act, AoA is responsible for facilitating the provision of home and community-based services and supports for older adults in this country, in coordination with CMS and other federal agencies. As a result, AoA is well-positioned to lead collaboration among the five federal agencies covered in our review. However, because of increases in Medicaid spending and emphasis on the role of HCBS in supporting health care patients, CMS has become an even more important partner to AoA in meeting older adults’ expected demand for HCBS. Thus, it may be most appropriate for the HHS Secretary to take the initiative in developing such a cross-agency federal strategy.
Thursday, May 28, 2015
Transamerica Center for Retirement Studies has issued their 16th Annual Retirement Survey of Older Workers. Retirement Throughout the Ages: Expectations & Preparations of American Workers was released in May of 2015. The 81 page report offers a number of key highlights, including views by age group (in ten year increments). The report provides recommendations for workers, employers and policymakers. The report offers this conclusion
Workers of all ages have similar challenges, dreams, fears, and expectations of retirement. Depending on their age and stage in life, they also face unique opportunities to improve their long-term financial security. Although it may seem overwhelming for many, taking one step at a time can lead to significant improvements over the long-term. The following three pages of these Key Highlights outline such steps for workers, employers, and policymakers.
It’s never too soon or too late to start saving and planning for retirement.
Wednesday, May 27, 2015
In my preparation for an upcoming talk show on WPSU on "Caring for Mom & Dad," I had the incentive to get to my stack of "must read" books to focus on The Aging of Dignity: Preparing for the Elder Boom in a Changing America, by Ai-Jen Poo (New Press 2015). What I very much like about this book is the broad lens it brings to aging demographics, focusing not on "burdens" but on "opportunities" to be a more productive, healthy society by dealing realistically with the need for both professional caregivers and family caregivers. Ai-Jen Poo writes:
Aging at home necessitates home care workers. Yet the 3 million people currently in the home care workforce cannot meet even the current need, let alone the demand for care that will accompany the elder boom. We will need at least 1.8 million additional home care workers in the next decade. As a result, care giving, specifically home care, is the fastest growing of all occupations in the nation....
With some course corrections in our culture and in our institutions, we can have the care infrastructure that will enable us to live our full potential. . . . The moral of this story is that a caring America is entirely within reach.
Not surprisingly, given her inspiring call for action, Ai-Jen Poo was a MacArthur "genius" grant recipient in 2014. She is one of the commentators on Caring for Mom & Dad, and in Pennsylvania, she will be part of our panel for WPSU's Conversations Live following the airing of the documentary on Thursday, May 28. The documentary is at 8 p.m., and the audience can "call-in, e-mail or text-in"beginning at 9 p.m. More details and links available here about the documentary and schedules here.
May 27, 2015 in Consumer Information, Dementia/Alzheimer’s, Elder Abuse/Guardianship/Conservatorship, Ethical Issues, Grant Deadlines/Awards, Health Care/Long Term Care, Medicaid, Medicare, Statistics, Television | Permalink | Comments (0) | TrackBack (0)
Friday, May 22, 2015
In the May 2015 issue of Conflict Resolution Quarterly, four authors use quantitative and qualitative data collected in Australia to identify risk factors for the financial abuse of older people by a family member, analyze the potential usefulness of mediation as a strategy to prevent this form of elder abuse, and to identify knowledge and skills important to mediators facing potential financial abuse.
The authors note that mediation is in the early stages of consideration as a strategic tool for combating financial elder abuse, and thus much of their report focuses on "potential" risks or benefits of mediation, rather than instances of its use. Nonetheless their study leads to interesting conclusions, including:
(1) enhancing the rights and wishes of older people,
(2) opening and facilitating communication between family members and older persons,
(3) enhancing accountability and responsibility of family members, and
(4) reducing family conflict.
The authors also identify potential concerns, including:
Thursday, May 21, 2015
Anyone who's noticed the upsurge in M&A activity in the senior care industries will want to take special notice of today's news, with the announcement that CVS Health will spend $10.4 billion to buy Omnicare, thus giving CVS an even stronger pipeline for prescription drug distribution to the elderly. (In 2006, CVS acquired Caremark Rx Inc. for a reported $21 billion.)
The deal announced Thursday will give one of the nation's biggest pharmacy benefits managers national reach in dispensing prescription drugs to assisted living and skilled nursing homes, long-term care facilities, hospitals and other health care providers. Omnicare's long-term care business operates in 47 states and the District of Columbia. With more people entering assisted-living residences as the U.S. population ages, CVS Health says there is a "substantial growth opportunity" for companies serving those patients.
Cincinnati's Omnicare also provides pharmacy consulting and runs another segment that provides specialty pharmacy services. Specialty drugs are complex medications that treat certain forms of cancer or hepatitis C, among other conditions. They often represent treatment breakthroughs but can cost considerably more than other prescriptions. Use of these drugs is climbing, and insurers and employers are looking for help containing that cost.
This deal should keep a lot of lawyers busy! From The American Lawyer, news of four major law firms involved in the latest CVS acquisition.
UPDATE: Here's an interesting editorial observation from an industry observer, describing Omnicare as the giant "lion of the jungle" who is now being gobbled up by giant CVS as the T-Rex. Amusing, but apt, metaphors and observations about the potential implications for the public.
St. Louis Elder Law Attorney Martha Brown recently recommended a 2013 documentary, writing: "It is called 'Moving with Grace.' It is played a lot in St. Louis on the local PBS station as reporter Stone Phillips and his parents lived in St. Louis. It is a wonderful documentary about the trials and tribulations of aging parents without the drama of a dysfunctional family." That is an important message, right? The challenges associated with "growing older" can hit everyone, even the "best" of families.
American Public Television, that distributes the program, previews it and offers a link to scheduling in your area here, explaining:
Like many baby boomers, former NBC anchor Stone Phillips and his siblings found themselves caring for their aging parents. Ninety-two-year-old Vic, a World War II veteran, copes with chronic heart issues, although his mind and memory remain "as reliable as a Bob Gibson fastball." Grace, his wife of 66 years, suffers from dementia, which robs the once-gregarious former teacher of her short-term memory. MOVING WITH GRACE, an intimate documentary Phillips produced and shot, follows this charming couple as they move out of the family home in Missouri and adapt to life first in a retirement community and later in an assisted-living facility. This honest and, at times, poignant story highlights the common struggles associated with elder care and its consequences.
Thank you, Martha, for sharing this resource!
May 21, 2015 in Cognitive Impairment, Consumer Information, Current Affairs, Dementia/Alzheimer’s, Ethical Issues, Health Care/Long Term Care, Housing, Television | Permalink | Comments (0) | TrackBack (0)
Wednesday, May 20, 2015
This week I attended the 16th Annual Meeting of the Massachusetts Life Care Residents Association (MLCRA) near Boston. Having last met with the group in 2011, I was impressed with the residents' on-going commitment to staying abreast of legal and practical developments affecting life care and continuing care (CCRC) models for senior living. Their organization has some 800 individual members, representing a majority of the communities in the state.
My preparation for the meeting gave me the opportunity to read one of those troubling "unpublished" -- but still significant -- opinions that shed light on attempts to make consumer protections stick. Here the "contract" trumped the statute.
In a February 2014 decision in Krens, v. 1611 Cold Spring Road Operating Company, a son who sought refund of his deceased mother's $282,579 partially "refundable" Entrance Fee was denied relief by a Massachusetts appellate court, despite the fact that Massachusetts law expressly mandated that a continuing care contract "shall provide" for a refund to be paid "when the resident leaves the facility or dies." The reasoning? The actual contract provided merely that the refund could be paid "within 30 days of actual occupancy of the vacated unit by a new resident." More than three years had elapsed since the mother's passing, apparently without the unit being "resold" or rented, and therefore the CCRC operating company took the position that no refund obligation had been triggered.
May 20, 2015 in Consumer Information, Estates and Trusts, Ethical Issues, Health Care/Long Term Care, Housing, Property Management, Retirement, State Cases, State Statutes/Regulations | Permalink | Comments (1) | TrackBack (0)
Monday, May 18, 2015
Publically-traded Brookdale Senior Living, founded in 1978, has grown to become the largest owner and operator of "senior living" communities in the U.S., including for-profit continuing care retirement communities (CCRCs). Thus, it is good to keep an eye on the finances of Brookdale for those of us interested in the long-term financial health of CCRCs and other senior housing options.
Steve Monroe at Irving Levin Associates notes that Brookdale "was no different than the rest of the market, posting sharp drops in first quarter occupancy" for 2015:
"The legacy Emeritus [a component of Brookdale, following a 2014 merger] properties posted a 110 basis point decline from the fourth quarter of 2014, and a whopping 200 basis point decline from a year ago. The legacy Brookdale properties dropped 80 basis points sequentially and 110 basis points from a year ago. This was not good news, but not unexpected. Oddly enough, the legacy Brookdale properties had a 250 basis point increase in community operating margin to 35.2% despite the occupancy declines. The Emeritus properties had a 90 basis point sequential drop in margin, which makes more sense."
How do you achieve a significant increase in "operating margin" despite "occupancy declines?" A good question to ponder. Steve Monroe continues: "The reasons for the legacy Brookdale improvement were a combination of cost controls and more pricing flexibility. Move-ins have been increasing, which is great, but 'cost controls' always make me nervous, especially with the current acuity creep. Stay tuned."
The reference to "acuity creep" is to the increase in average age and frailty of new residents, compared with past years (especially before the financial crisis of 2008-10). This trend impacts CCRCs in several ways, both in terms of market appeal to healthier potential residents, and operating costs tied to an earlier need for higher levels of care. An additional question may be whether low interest rates have supported a bubble in certain segments of senior housing despite the softer occupancy rates, and whether an eventual return to higher capitalization rates will result in lower values and additional consequences.
Along that same line, the Philadelphia Inquirer published a recent article in their "retirement" news edition, noting "Continuing-Care Retirement Community Choice Requires Diligence," by Harold Brubaker, with tips on what to ask if you are a consumer considering a CCRC option.
Friday, May 15, 2015
On May 12, the U.S. Department of Justice announced resolution of a disabilities discrimination complaint initiated by residents of a Continuing Care Retirement Community (CCRC) in Virginia.
The resolution includes filing of a complaint and consent order that resolves allegations that Fort Norfolk Retirement Community Inc. (Fort Norfolk) violated the Fair Housing Act by instituting policies that discriminated against residents with disabilities at Harbor’s Edge, a CCRC in Norfolk, Virginia:
The consent order, which still needs to be approved by the court . . . along with a complaint, in the U.S. District Court of the Eastern District of Virginia. The complaint alleges that beginning in May 2011, Fort Norfolk instituted a series of policies that prohibited, and then limited, residents in the assisted living, nursing and memory support units at Harbor’s Edge from dining in dining rooms or attending community events with independent living residents. The complaint also alleges that when residents and family members complained about these policies, Fort Norfolk retaliated against them. In addition, the complaint alleges that Fort Norfolk had polices that discriminated against residents who used motorized wheelchairs by requiring those residents to pay a non-refundable fee, obtain liability insurance and obtain Fort Norfolk’s permission.
Under the consent order, Fort Norfolk will pay $350,000 into a settlement fund to compensate residents and family members who were harmed by these policies. Fort Norfolk will also pay a $40,000 civil penalty to the United States. In addition, Fort Norfolk will appoint a Fair Housing Act compliance officer and will implement a new dining and events policy, a new reasonable accommodation policy and a new motorized wheelchair policy.
There is a history of similar issues arising in other CCRCs. For example, in 2008, in California, CCRC resident Lillian Hyatt initiated, and eventually resolved to her satisfaction, a discrimination claim based on a ban on "walkers" in the dining rooms of her community.
As the average age of residents in CCRCs has increased in recent years, the "appearance" issues are sometimes raised as a marketing or image concern, contrasting sharply with the expectations of individual residents as they age and seek continued access to the full range of services in their community.
Our thanks to Karen Miller, Esq., of Florida, for bringing the recent Virginia case to our attention.
Thursday, May 14, 2015
PBS is premiering a powerful documentary special, Caring for Mom & Dad, during the month of May, with Meryl Streep as the narrator. A sample? Many of us might find resonance with one adult's "bad daughter" (or "bad son") feelings of guilt, candidly admitted here.
Even more important than the video itself will be the conversations that follow viewing. Check your local public t.v. schedule to see when the program will air in your area. (You can check here, to see if the documentary is scheduled yet in your viewing area -- go to the drop down menu for "Schedule.") Plus, in some markets, the documentary will be combined with a live call-in opportunity for individuals and families to explore health care, social care, financial topics and legal issues with a panel of experts.
My own university, Penn State, is hosting the special on Thursday, May 28, 2015 at 8:00 p.m. (Eastern time), followed by Conversations Live at 9:00 p.m. That is two weeks from today on WPSU-TV, a station that reaches a viewing area of 29 counties in central Pennsylvania. In addition, the Conversations Live program will be broadcast on WPSU-FM radio and can be viewed "on-line" at WPSU.org.
As a result of an invitation to be part of the WPSU studio panel, I've had the opportunity to watch the documentary -- several times (it's that interesting!) -- in preparation to help in responding to audience comments, emails and call-in questions. Additional Conversations Live guests include:
Ai-jen Poo, co-director of Caring Across Generations and director of National Domestic Workers Alliance, will be joining via satellite from D.C. Ai-jen Poo is featured in the documentary, and she also has a particular interest in enactment of a Domestic Workers' Bill of Rights, to deal realistically and fairly with the work force that will be necessary to meet the boomer generation's care needs.
Dr. Gwen McGhan, Hartford Center for Geriatric Nursing Excellence at Penn State, with a research background on informal family caregiving.
Jane McDowell, Hartford Center for Geriatric Nursing Excellence at Penn State, and a geriatric nurse practitioner.
The documentary was produced by WGBH-Boston, with funding assistance from AARP and Pfizer.
Please join us and share your stories and observations. The documentary starts with personal stories, but the public policy messages that emerge are ones that need to be heard at state and federal levels -- and heard clearly -- for there to be hope for realistic, necessary and timely solutions.
May 14, 2015 in Cognitive Impairment, Consumer Information, Current Affairs, Dementia/Alzheimer’s, Elder Abuse/Guardianship/Conservatorship, Ethical Issues, Federal Statutes/Regulations, Film, Health Care/Long Term Care, Medicaid, Medicare, Social Security, State Statutes/Regulations | Permalink | Comments (0) | TrackBack (0)
Wednesday, May 13, 2015
The recent issue of Bifocal, the bi-monthly Journal of the ABA Commission on Law and Aging has a great line-up of articles, including a piece by Social Security Administration (SSA) specialist Janet Truhe on Social Security Seeks Pro Bono Lawyers to Meet Need for Representative Payees. She notes that many disabled individuals do not have family members or other trusted persons who can serve as their agents for receipt and management of Social Security benefits. Anticipating the need for "rep payees" will continue to grow as boomers age, SSA is recruiting attorneys to serve:
Recently, the agency announced the implementation of a pro bono pilot in the State of Maryland (where SSA is headquartered), which is aimed at expanding the pool of suitable representative payee candidates statewide. SSA believes that partnership with the legal community for this purpose is a natural fit....
One particular advantage of this pro bono opportunity is that any attorney, regardless of his or her specialty, can serve as a representative payee with SSA providing any needed assistance. SSA has created a web site for attorney volunteers with training and other information about the role of a representative payee. Any licensed attorney in Maryland, or in neighboring jurisdictions, who would like to volunteer as a representative payee for a beneficiary residing in Maryland can go to http://www.socialsecurity.gov/payee/probonopilot.htm and complete an online registration form. SSA will send the volunteer attorney’s contact information to the servicing local field office. When SSA needs a representative payee for a particular beneficiary, that field office will contact one of the volunteer attorneys and make an appointment for the attorney to come in for an interview and meet the beneficiary.
Hat tip to ElderLawGuy Jeff Marshall for pointing out this SSA recruitment effort.
One option for seniors needing more income late in life is using the equity in their homes, and "reverse mortgages" may make it possible for the older homeowner to stay in the home longer. The Washington Post recently explored the option of having family members serve as the source of reverse mortgage funding. When the Kids Provide a Reverse Mortgage for Mom and Dad outlines potential pros and cons of family-based financing, starting with the mechanics of the loan:
Here’s a simplified example: Say you and two siblings want to help Mom and Dad, who are in their late 70s. You and your siblings are all doing well enough that you have at least some cash to spare. Ultimately, you want to retain your parents’ house for the estate once your parents pass away, keep costs to a minimum and sell the property only when you, not a faraway bank, choose to do so.
So you sit down with Mom and Dad and determine that, at least for the foreseeable future, they will need about $1,500 in additional income a month. You and your siblings agree to apportion the payments among yourselves in some way, maybe a commitment of $500 a month each for a period of years. You also pick an interest rate that achieves a win-win result for you and your parents — say, 3 percent annually. That’s much lower than a commercial lender would charge but higher than what you’ve been earning on your bank deposits or money market funds. There are no required fees upfront — hey, it’s Mom and Dad.
Thanks to Maryland elder law attorney Morris Klein for the pointer to this article.
Tuesday, May 12, 2015
We've written on this blog several times about successful prosecutions connected to so-called "off label" drug use, including the use of antipsychotics for agitation in dementia patients. See here and here, for example. Now, courtesy of a New York Times article, there is news of a pharmaceutical company's lawsuit to preempt such prosecutions, raising First Amendment free speech rights as grounds for off-label advocacy:
On Thursday, Amarin Pharma took the unusual step of suing the Food and Drug Administration, arguing that it has a constitutional right to share certain information about its product with doctors, even though the agency did not permit the company to do so. Lawyers for the company said that they believed their case was the first time a manufacturer had pre-emptively sued the agency over the free-speech issue, before it had been accused of any wrongdoing. Other companies have sued the agency only after they have gotten into trouble....
Lawyers for Amarin say the company is not proposing to market Vascepa to a wider population of patients, merely to share with doctors the results of a 2011 company-sponsored clinical trial that showed the drug lowered triglycerides in patients with “persistently high” levels....
More details about the suit available here.