Tag Archives: Health Care

Politics Versus Policy: Plan B’s Place in the Reproductive Rights Movement Today

By Chelsea Stevens

Reproductive rights do not begin and end with a woman’s legal right to have an abortion. The reproductive rights movement encompasses everything from the need for comprehensive sexual education to the push for more adequate and readily available reproductive health facilities. Recently, in New York, a battle over contraception sparked a reproductive rights controversy. While this may sound surprising since condoms are available at nearly every drug store and are clearly in no short supply, gaining access to hormonal or implantable forms of contraception for women is no easy feat. Birth control pills require a prescription and the recurring monthly cost has made them far more expensive than male condoms.[1] An intrauterine device (IUD) can be costly and requires insertion by a medical professional. And what happens when these methods of birth control, whether condom or contraceptive pill, fail?

In 2006, the Food and Drug Administration (“FDA”) approved non-prescription access to Plan B for women aged 18 and older.[2] Plan B and Plan B One-Step are “emergency contraceptives that can be taken to reduce the risk of pregnancy after unprotected intercourse” and are “most effective when taken immediately after intercourse,” preferably within 24 hours.[3] These contraceptives “have not been shown to cause any change in the uterus that could interfere with implantation of a fertilized egg”[4] and are not to be confused with RU-486, better known as the abortion pill. Instead, Plan B reduces the number of sperm cells in the uterine cavity, immobilizes sperm, impedes further passage of sperm cells into the uterine cavity, and “has the capacity to delay or prevent ovulation from occurring.”[5]

Until recently, women under the age of 18 needed a prescription to obtain Plan B.[6] If the monetary cost of having to go to the doctor for this prescription wasn’t enough of a deterrent for young women attempting to access this emergency contraceptive, the lengthy process of making a doctor’s appointment, getting to the doctor, and picking up a prescription undercut the very effectiveness of Plan B, which grows less effective as time passes. However, on April 4, 2013, in Tummino v. Hamburg (Tummino II), a federal judge ordered that Plan B be made available over-the-counter for women of all ages.[7]

The judge who heard Tummino II, the Honorable Edward R. Korman of the Eastern District of New York, addressed a similar issue in 2009 in Tummino v. Torti (Tummino I).[8] In that case, Judge Korman wrote that the FDA’s failure to respond to the citizen petition seeking over-the-counter access to Plan B for women of all ages was arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making.[9] Judge Korman directed the FDA to make Plan B available to 17-year-old women without a prescription, because the same evidence relied on by the agency to support over-the-counter access to the drug by 18-year-olds applied equally to 17-year-olds.[10] The FDA conceded this point, stating it was “consistent with the scientific findings [the FDA] made in 2005.”[11]

Upon reviewing the citizen petition and the scientific research, the FDA decided to allow the marketing of Plan B without a prescription “for all females of child-bearing potential.”[12] Yet Health and Human Services Secretary Kathleen Sebelius countermanded the move by the FDA, specifically citing the fact that the manufacturer had failed to study whether the drug was safe for 11-year-old girls.[13] President Obama endorsed this decision, explaining that “the reason [Secretary Sebelius] made this decision was she could not be confident that a 10-year-old or an 11-year-old . . . should be able . . . to buy a medication that potentially, if not used properly, could end up having an adverse effect.”[14]

However, in Tummino II, Judge Korman makes it clear that he does not believe this case is about the potential misuse of Plan B by 11-year-olds, only “about 10 percent of whom are physically able to bear children” according to the New York Times.[15] Among other reasons, Judge Korman points out that emergency contraceptives would be among the safest drugs sold over-the-counter, that the number of 11-year-olds using these drugs is likely to be miniscule, and that the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions.[16] Judge Korman wrote, instead, that “the secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent.”[17]

Aside from the problem of the Secretary of Health and Human Services overruling the FDA in an area which Congress entrusted primarily to the FDA and which “fell within the scope of the authority that the Secretary expressly delegated to the Commissioner,” Judge Korman said the motivation for the Secretary’s action was “obviously political.”[18] This was the first time a cabinet member had ever publicly countermanded a determination by the FDA[19] and it was a decision that “many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.”[20] Even looking past the obvious political motivation, Judge Korman said that the reasons Sebelius provided were unpersuasive and failed to offer a coherent justification for denying the over-the-counter sale of Plan B to the “overwhelming majority of women of all ages who may have need for those drugs and who are capable of understanding their correct use.”[21]

It is notable that this debate over access to Plan B takes place at a time that marks the fortieth anniversary of the historic reproductive rights case Roe v. Wade.[22] Now, four decades after the Supreme Court handed down that landmark decision, women are still fighting for reproductive freedom in America. In fact, this year in particular, state legislatures have been taking action not to preserve women’s reproductive rights, but rather to limit, restrict, and in many cases all but eliminate them.[23] For instance, the Arkansas State Senate recently approved a bill prohibiting the state from awarding grants to abortion providers, which could affect “doctors and entities like rape crisis centers if they refer women to abortion providers.”[24] Similarly, North Dakota Governor Jack Dalrymple recently signed into law the nation’s toughest abortion restrictions, forbidding abortion as soon as a fetal heartbeat is “detectable,” which can be as early as six weeks into a pregnancy, and effectively banning nearly all abortions in the state.[25] Meanwhile, Mississippi is on the brink of becoming the only state in the country without an abortion clinic.[26]

Judge Korman’s opinion in Tumino II is not only a much-needed step forward at a time when the reproductive rights movement is in crisis, but it also boldly questions the legitimacy of allowing politically-motivated officials to make decisions regarding a drug’s availability for reasons other than its safety and effectiveness.[27] And, just to be clear, Judge Korman is not simply pushing a liberal agenda: “[h]e clerked for a former Republican congressman, was appointed by Ronald Reagan and served in the Justice Department under President Richard M. Nixon.”[28] Rather, Judge Korman is taking a stand against allowing “politics [to triumph] over policy.”[29]

No matter how controversial the issue of reproductive rights is in America, citizens should have the right to access FDA-approved forms of contraception, such as Plan B. Regardless of whether they come from members of lobbying groups or agents of the Executive Office, personal and subjective opinions about the appropriate age at which one should have access to contraception should not affect what a citizen is legally allowed to do. And while some critics argue that Korman’s decision will encourage women to “be more cavalier and not use more reliable birth control” because they “may bypass birth control pills or IUDs altogether if they know this option is available to them,”[30] the fact of the matter remains that individuals have the right to decide independently what means of contraception they want to use and when. If there is a form of contraception like Plan B that is both FDA-approved and helps avoid unwanted pregnancy in an emergency situation, everyone in America who is sexually active, regardless of age, should have access to it. Judge Korman confirms that all Americans have the right to have this access in Tummino II.

Now, onto the next step: lowering the cost of emergency contraception like Plan B (and contraception geared toward the female body in general) so that all Americans can actually practice the right to reproductive self-determination, regardless of their socioeconomic standing.

Chelsea is currently a 2L at NYU School of Law. She is the Symposium Editor of the Review of Law & Social Change and Co-Chair and Treasurer of Law Students for Reproductive Justice.


[1] The Affordable Care Act is lowering the cost of contraception for women on some forms of birth control. See Patient Protection and Affordable Care Act, Pub.L. No. 111–148, 124 Stat. 119 (2010), amended by Health Care and Education Reconciliation Act of 2010 (“HCERA”), Pub.L. No. 111–152, 124 Stat. 1029 (2010); U.S. Dep’t of Health & Human Services, Affordable Care Act Rules on Expanding Access to Preventive Services for Women, HealthCare.gov (last visited Apr. 28, 2013), http://www.healthcare.gov/news/factsheets/2011/08/womensprevention08012011a.html.

[2] Tummino v. Hamburg (Tummino II), No. 12-CV-763 (ERK) (VVP), 2013 WL 1348656, at *1 (E.D.N.Y. Apr. 4, 2013).

[3] Id.

[4] Id.

[5] Id.

[6] Id.

[7] Id.at *32.

[8] Tummino v. Torti (Tummino I), 603 F. Supp. 2d 519 (E.D.N.Y. 2009), amended sub nom. Tummino v. Hamburg, No. 05-CV-366 (ERK) (VVP), 2013 WL 865851 (E.D.N.Y. Mar. 6, 2013).

[9]  Id. at 523 n.4.

[10] Id. at 549.

[11] See Food & Drug Admin., Updated FDA Action on Plan B (levonorgestrel) Tablets (Apr. 22, 2009), as cited in Tummino II at *4.

[12] Tummino II at *4.

[13] Pam Belluck, Judge Strikes Down Limits on Morning-After Pill, N.Y. Times (Apr. 5, 2013), http://www.nytimes.com/2013/04/06/health/judge-orders-fda-to-make-morning-after-pill-available-over-the-counter-for-all-ages.html.

[14 Tummino II at *6 (citing Barack H. Obama, President, Statement (Dec. 8, 2011), available at http://www.whitehouse.gov/the-press-office/2011/12/08/statement-president) (internal quotation marks omitted).

[15] Belluck, supra note 13; see Tummino II at *4 (“This case is not about the potential misuse of Plan B by 11-year-olds.”).

[16] Tummino II at *4.

[17] Id. at *26.

[18] Id. at *6–7; see also Delegations of Authority to the Commissioner of Food and Drugs, republished in FDA Staff Manual Guide § 1410.10, available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM273771.pdf.

[19] Gardiner Harris, White House and the FDA Often at Odds, N.Y. Times, Apr. 3, 2012 at A1.

[20] Id.

[21] Tummino II at *7.

[22] 410 U.S. 133 (1973).

[23] See Editorial, The Campaign to Outlaw Abortion, N.Y. Times (Mar. 29, 2013), http://www.nytimes.com/2013/03/30/opinion/the-campaign-to-outlaw-abortion.html; see generally S.B. 818, 89th Gen. Assemb., Reg. Sess. (Ark. 2013), available at http://www.arkleg.state.ar.us/assembly/2013/2013R/Bills/SB818.pdf; Arkansas: Bill Targeting Planned Parenthood Advances, N.Y. Times (Apr. 9, 2013), http://www.nytimes.com/2013/04/10/us/arkansas-bill-targeting-planned-parenthood-advances.html [hereinafter Bill Advances]; John Eligon & Erik Eckholm, New Laws Ban Most Abortions in North Dakota, N.Y. Times (Mar. 26, 2013), http://www.nytimes.com/2013/03/27/us/north-dakota-governor-signs-strict-abortion-limits.html.

[24] S.B. 818, supra note 23; Bill Advances, supra note 23.

[25]Eligon, supra note 23.

[26] Campbell Robertson, Judge Prevents Closing of Mississippi’s Sole Abortion Clinic, N.Y. Times (Apr. 15, 2013), http://www.nytimes.com/2013/04/16/us/ruling-prevents-closing-of-mississippis-only-abortion-clinic.html.

[27] Belluck, supra note 13.

[28] Rachel Weiner, Judge Criticizes Obama Administration in Plan B Decision, Wash. Post (Apr. 5, 2013), http://www.washingtonpost.com/blogs/post-politics/wp/2013/04/05/judge-attacks-obama-administration-in-fda-decision.

[29] Id.

[30] Loren Grush, Plan B Ruling: Doctors Divided Over Lifting Age Restrictions on Morning-After Pill, FOXNews.com (Apr. 5, 2013), http://www.foxnews.com/health/2013/04/05/plan-b-ruling-doctors-divided-over-lifting-age-restrictions-on-morning-after.

A Penny Saved Can Be a Penalty Earned: Nursing Homes, Medicaid Planning, the Deficit Reduction Act of 2005, and the Problem of Transferring Assets

Catherine M. Reif

Christian Nursing Home

(Photo Credit: sheilaz413 via flickr)

Abstract

The Deficit Reduction Act of 2005 (DRA) makes it difficult for a senior citizen to transfer financial assets and subsequently qualify for Medicaid’s long-term care benefit. It makes it so difficult, in fact, that it creates a class of sick, poor senior citizens who do not qualify for Medicaid because they inadvertently transferred assets long before they had reason to believe that they would need long-term care. Essentially, Medicaid law expects senior citizens who gave away money during the past five years to recover it and spend it on nursing home care before they qualify for Medicaid. However, senior citizens who simply spend their money—on cars, home improvements, or whatever they choose—are not expected to recover it and incur no penalty. The hardship waivers that are supposed to provide a safety net for ill senior citizens who are denied Medicaid coverage are useless because they are applied so restrictively. The result is the exclusion from Medicaid of the people it was designed to serve.

This article discusses how financial asset transfers are treated under Medicaid law, both before and after the DRA’s enactment, and analyzes whether Medicaid policy is served by the DRA’s changes. The article also proposes solutions to the problems caused by the DRA and presents a strategy for seniors to transfer some financial assets and still qualify for Medicaid. Finally, the article advocates for changes to Medicaid law, including changing the hardship waiver procedures, increasing the asset exemption amount, and rolling back the DRA. These changes would enable Medicaid law to perform the function for which it was designed—to provide a safety net for our nation’s poorest and sickest citizens.

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Money and Rights

Deborah Hellman

20 Dollars art3

20 Dollars art3 (Photo credit: Wikipedia)

Money is necessary to exercise some constitutional rights; for example, getting an abortion requires cash.  In this article,

Deborah Hellman asks: when do constitutionally protected rights include an accompanying right to spend or give money?

Based on a thorough analysis of Supreme Court cases, Hellman offers an underlying principle that explains when a constitutional right includes a concomitant right to give or spend money.  Constitutional rights are divided into two types: those that have a concomitant right to give or spend of money, and those that do not have such a concomitant right.  Hellman describes the former category as an “integral” approach and the latter as a “blocked” approach.

In Hellman’s view, the Supreme Court has established an integral approach when no adequate alternative means exists to exercise that right.  In contrast, most of those Supreme Court cases that have established a blocked approach have done so because there is an adequate alternative mechanism to exercise the right.

In this article, Hellman calls upon us to challenge our understanding of the relationship between money and constitutional rights.  In doing so, she determines that Citizens United may have been wrongly decided because the public campaign finance system provides an adequate alternative mechanism to private political contribution.

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Bad Medicine: Prescription Drugs, Preemption, and the Potential for a No-Fault Fix

Amalea Smirniotopoulos

Various pills

Various pills (Photo credit: Wikipedia)

Abstract

For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA’s regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries—even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs’ lawyers alike.

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