Law Commons^™

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Unduly Burdening Women’S Health: How Lower Courts Are Undermining Whole Woman’S Health V. Hellerstedt, Leah M. Litman

Michigan Law Review Online

At the end of the Supreme Court’s 2016 Term, the Court issued its decision in Whole Woman’s Health v. Hellerstedt. One of the more closely watched cases of that Term, Hellerstedt asked whether the Supreme Court would adhere to its prior decision in Planned Parenthood v. Casey, which reaffirmed that women have a constitutionally protected right to decide to end a pregnancy.

The state of Texas had not formally requested that the Court revisit Casey or the earlier decision Casey had affirmed, Roe v. Wade, in Hellerstedt. But that was what Texas was, in effect, asking …

No Good Options: Picking Up The Pieces After King V. Burwell, Nicholas Bagley, David K. Jones

Articles

If the Supreme Court rules against the government in King v. Burwell, insurance subsidies available under the Affordable Care Act (ACA) will evaporate in the thirty-four states that have refused to establish their own health-care exchanges. The pain could be felt within weeks. Without subsidies, an estimated eight or nine million people stand to lose their health coverage. Because sicker people will retain coverage at a much higher rate than healthier people, insurance premiums in the individual market will surge by as much as fifty percent. Policymakers will come under intense pressure to mitigate the fallout from a government loss …

Predicting The Fallout From King V. Burwell - Exchanges And The Aca, Nicholas Bagley, David K. Jones, Timothy Stoltzfus Jost

Articles

The U.S. Supreme Court's surprise announcement on November 7 that it would hear King v. Burwell struck fear in the hearts of supporters of the Affordable Cara Act (ACA). At stake is the legality of an Internal Revenue Service (IRS) rule extending tax credits to the 4.5 million people who bought their health plans in the 34 states that declined to establish their own health insurance exchanges under the ACA. The case hinges on enigmatic statutory language that seems to link the amount of tax credits to a health plan purchased "through an Exchange established by the State." According to …

Abortion And Informed Consent: How Biased Counseling Laws Mandate Violations Of Medical Ethics, Ian Vandewalker

Michigan Journal of Gender & Law

If we slightly change the facts of the story about the discouraging doctor, it becomes a story that happens every day. Abortion patients face attempts to discourage them from terminating their pregnancies like those the imaginary doctor used, as well as others-and state laws mandate these attempts. While the law of every state requires health care professionals to secure the informed consent of the patient before any medical intervention, over half of the states place additional requirements on legally effective informed consent for abortion. These laws sometimes include features that have ethical problems, such as giving patients deceptive information. Unique …

Drugged, Carl E. Schneider

Articles

The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …

Border Patrol, Carl E. Schneider

Articles

Recently, the Supreme Court has encountered cases that concern perhaps our weightiest bioethical issue-how medical care is to be rationed. But this does not mean that the Court must therefore assess the justice of rationing, as many people incited by many journalists now fondly and firmly believe. In explaining why, we begin with a story about how Learned Hand remembered saying one day to Justice Holmes, "Well, sir, goodbye. Do justice!" Holmes turned quite sharply and said: "That is not my job. My job is to play the game according to the rules." If the Court doesn't do justice, what …

Going To Pot, Carl E. Schneider

Articles

In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.

Making Sausage: The Ninth Circuit's Opinion, Carl E. Schneider

Articles

As I write, the Supreme Court has just agreed to hear Compassion in Dying v. Washington and Quill v. Vacco, the two cases in which United States circuit courts of appeals held that a state may not constitutionally prohibit physicians from helping a terminally ill person who wishes to commit suicide to do so. These cases have already received lavish comment and criticism, and no doubt the Supreme Court's opinion will garner even more. Reasonably enough, most of this analysis addresses the merits of physician-assisted suicide as social policy. I, here, want to talk about how setting bioethical policy …

Paradox And Pandora's Box: The Tragedy Of Current Right-To-Die Jurisprudence, Cathaleen A. Roach

University of Michigan Journal of Law Reform

Part I of this Article examines the trilogy of recent right-to-die cases and contrasts the results of those cases with recent national opinion polls and statistical surveys of the issue. Part II examines federal and state legislative responses to the debate. It suggests that both the courts and legislatures are out of sync with an emerging national consensus on the death-with- dignity debate. In fact, the federal legislative response may only exacerbate the problem. Instead of creating new rights, it feeds individuals into the existing state network, which is a quagmire of confusing and inequitable statutory provisions. Part III examines …