Law Commons^™

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Evan R. Youngstrom

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …

Gandhi’S Prophecy: Corporate Violence And A Mindful Law For Bhopal, Nehal A. Patel

Nehal A. Patel

AbstractOver thirty years have passed since the Bhopal chemical disaster began,and in that time scholars of corporate social responsibility (CSR) havediscussed and debated several frameworks for improving corporate responseto social and environmental problems. However, CSR discourse rarelydelves into the fundamental architecture of legal thought that oftenbuttresses corporate dominance in the global economy. Moreover, CSRdiscourse does little to challenge the ontological and epistemologicalassumptions that form the foundation for modern economics and the role ofcorporations in the world.I explore methods of transforming CSR by employing the thought ofMohandas Gandhi. I pay particular attention to Gandhi’s critique ofindustrialization and principle of swadeshi (self-sufficiency) …

The Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Harvey L. Fiser

Coming to a hospital near you, the medically enhanced doctor - a doctor who thinks faster, is better with short and long term memory, is calmer during surgery, can work double shifts with little cognitive fatigue, and one day may have the memories of years of experience without actually having had them. With the expanded use of cognitive enhancing pharmaceuticals such as Adderall, Provigil, and more on the way, we are already seeing changes in education and the corporate world. From reaching a “normal” status for a person with an ADHD diagnosis to creating the “supernormal” employee with cognitive enhancers, …

The "Uberization" Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan

Fazal Khan

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined …

Everything Is Presumed In Texas, Benjamin Walther

Benjamin Walther

As this Article will reveal, the Fifth Circuit has traditionally been loath to apply the presumption against preemption in most cases. Texas courts, on the other hand, have consistently employed a particularly strong application of the presumption to all types of preemption cases. This inconsistency between these two jurisdictions creates an incentive for forum shopping. Generally, the courts rely on a defendant’s ability to remove a case to the federal courts to counteract the plaintiff’s exclusive power to decide the forum. This ability, however, is not available to a defendant within the context of preemption cases. As such, there is …

Mutual Pharmaceutical Co. V. Bartlett: A Need For “Explicit” Congressional Action And State Tort Law Reform, Kara A. Ritter

Kara A Ritter

No abstract provided.

The Continuing Battle Of Fda Regulation Of Dietary Supplements And Their Adverse Affect On Young Adults And Other Individuals, Andrew Bernard Jaffe

Andrew Bernard Jaffe

THE CONTINUING BATTLE OF FDA REGULATION OF DIETARY SUPPLEMENTS AND THEIR ADVERSE AFFECT ON YOUNG ADULTS AND OTHER INDIVIDUALS

Abstract

Ever since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) the Food and Drug Administration (FDA) has struggled to regulate dietary supplements. This is due to the definition of dietary supplements as foods in the act. This gives supplement manufacturers greater loopholes when introducing supplements on the market. The FDA’s inability to regulate dietary supplements efficiently has been present for decades. Multiple battles are still occurring today which is proven to have an adverse effect …

The Drug Shortage Crisis: What Happens When Generic Manufacturers "Just Say No", Stacey B. Lee

Stacey B. Lee

In the past five years, the number of drug shortages in the United States has nearly quintupled. The majority of shortages involve generic sterile injectables used to fight infectious diseases and treat cancer. These complex drugs are produced in a concentrated market consisting of only a few generic manufacturers. Any disruption in their supply can result in shortages that leave patients without access to life-saving drugs which in some cases are the only treatment for their condition. These chronic shortages have been linked to many possible factors including product quality concerns, discontinuation of product lines, changes in supply and demand, …

The Smokable Goods Tax: Crafting A Constitutional Marijuana Tax, Nima H. Mohebbi, Samuel T. Greenberg

Nima H. Mohebbi

Marijuana legalization and decriminalization has become a hot policy issue. Roughly twenty U.S. states have partially legalized marijuana (generally for medicinal purposes) and two states – Colorado and Washington – have legalized it for general adult recreational use. Given the likely hyper-growth of the cannabis market in view of the possible wide-scale legalization of marijuana, states might enjoy a potential budgetary windfalls from marijuana excise taxes. Marijuana, however, remains a federally controlled substance, the sale or use of which is subject to substantial penalties. For the states, this presents a potential problem in collecting excise taxes on marijuana – namely, …

"Rfra Exemptions From The Contraception Mandate: An Unconstitutional Accommodation Of Religion", Frederick Mark Gedicks, Rebecca G. Van Tassell

Frederick Mark Gedicks

Litigation surrounding use of the Religious Freedom Restoration Act to exempt employers from the Affordable Care Act’s “contraception mandate” is moving steadily towards eventual resolution in the U.S. Supreme Court. Both opponents and supporters of the mandate, however, have overlooked Establishment Clause limits on such exemptions. The fiery religious-liberty rhetoric surrounding the mandate has obscured that RFRA is a “permissive” rather than “mandatory” accommodation of religion—that is, a voluntary government concession to religious belief and practice that is not required by the Free Exercise Clause. Permissive accommodations must satisfy Establishment Clause constraints, notably the requirement that the accommodation not impose …

After Caronia: First Amendment Concerns In Off-Label Promotion, Stephanie Greene

Stephanie Greene

After Caronia: First Amendment Concerns in Off-Label Promotion by Stephanie M. Greene* Abstract The government has successfully prosecuted pharmaceutical companies for off-label promotion of drugs, maintaining that such promotion impermissibly undermines the FDA’s pre-market approval process and jeopardizes the public health. In several recent cases, however, pharmaceutical companies have alleged that regulations prohibiting such promotion are unconstitutional because off-label promotion is protected under the First Amendment. Two recent Supreme Court cases contain language that gives broad protection to advertising and marketing in the pharmaceutical field. This paper questions the reach of these cases as applied to the practice of off-label …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

Visual Gut Punch: Persuasion, Emotion, And The Constitutional Meaning Of Graphic Disclosure, Ellen P. Goodman

ellen p. goodman

The ability of government to “nudge” with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated in the relevant law and commentary. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

Conflicting Federal And State Medical Marijuana Policies: A Threat To Cooperative Federalism, Todd Grabarsky

Todd Grabarsky

The legal status of medical marijuana in the United States is something of a paradox. On one hand, federal government has placed a ban on the drug with no exceptions. On the other hand, over one-third of the states have that legalizes the cultivation, distribution, and consumption of the drug for medical purposes. As such, the usage of medical marijuana is an activity that is at the same time proscribed (by the federal government) and encouraged (by state governments through their systems of regulation and taxation). This Article seeks to shed light on this unprecedented nebulous zone of legality in …

Federal Prohibition Of Medical Marijuana In Pain Management: Undue, Unimportant, And Irrational, Michael L. Timm Jr.

Michael L. Timm Jr.

This paper provides a review of the historical right of the people of the United States to seek, and use, alternative medicinal treatment options in the realm of managing both the pain and symptoms associated with a variety of illnesses. The focus then turns to the right involved: a patient’s ability to employ medical marijuana instead of a commonly prescribed narcotic or mass-market non-steroidal anti-inflammatory analgesic (NSAIA) drug to manage pain and increase quality of life under the advice and consent of a treating physician. No one article has argued that there is a fundamental, important, or at least recognizable …

The Best Of Both Worlds: Applying Federal Commerce And State Police Powers To Reduce Prescription Drug Abuse, Stacey L. Sklaver

Stacey L. Sklaver

This article addresses the prescription drug abuse epidemic in the United States. In particular, it highlights that prescribers, as the gatekeepers of controlled substances, often lack the necessary education and training to properly prescribe such medications and to spot signs of abuse. This deficiency leads to patient overdoses and death, and resultant prescriber exposure to both civil and criminal liability.

Some states require controlled substance prescribers to obtain education on safe prescribing and abuse prevention methods, but many do not, yielding the need for a federal solution. The solution must address patient health, safety, and welfare under the purview of …

Direct And Enhanced Disclosure Of Researcher Financial Conflicts, Roy G. Spece Jr.

Roy G Spece Jr.

Abstract of DIRECT AND ENHANCED DISCLOSURE OF RESEARCHER FINANCIAL CONFLICTS OF INTEREST: THE ROLE OF TRUST In earlier writing I recommended direct disclosure of a major researcher financial conflict of interest, per capita funding—i.e., providing a fixed sum per subject recruited and enrolled in a study. This article adds a recommendation for enhanced direct disclosure. The enhancement in the disclosure is a summary of why per capita and excess payments are being discussed. The reason they are being discussed is because of their risk of introducing bias into researchers’ decisions regarding study design, implementation, and interpretation as well as concerning …

A Shot In Arm: Can Chemical Castration Statutes Cure Sex Offenders Legally And Ethically?, Robert Watters

Robert Watters

At least seven states currently have sex offender castration statutes. This article examines the legal and ethical appropriateness of those statutes against the successful and unsuccessful European models.

When Can You Teach An Old Law New Tricks?, Philip A. Wallach

Philip A Wallach

This article considers the distinctive legal and institutional dynamics involved when agencies interpret existing statutes for novel purposes. It argues that courts take into account policy-specific institutional factors, such as legislative dysfunction, when they consider the propriety of such novel interpretations, rather than employing universal ideas about institutional competencies. Where Congress has shown an inability to legislate in a policy area, courts are more likely to sympathize with changes in interpretation as partial substitutes for new legislation, but relying on old statutory language creates problems of statutory mismatch. The article contends that many arguments over statutory meaning mask disagreements about …

Mistake-Proofing Medicine: Legal Considerations And Healthcare Quality Implications, Arlen W. Langvardt

Arlen W Langvardt

MISTAKE-PROOFING MEDICINE: LEGAL CONSIDERATIONS

AND HEALTHCARE QUALITY IMPLICATIONS

Authors: John R. Grout, John W. Hill, Arlen W. Langvardt (corresponding author).

Abstract

In 1999, the Institute of Medicine estimated that approximately 98,000 deaths resulted annually from medical errors. This shocking number does not appear to have lessened during the intervening years. Although mistake-proofing techniques similar to those that have proven useful in the product liability context hold great promise for reducing the number of medical errors, the adoption of such techniques in healthcare settings has not occurred to the extent it should have.

This article examines potentially useful mistake-proofing techniques, explores …

Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich

Janet Freilich

This article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk …

The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law’S Doctrine Of Equivalents With The Fda’S Bioequivalence Requirement, Janet Freilich

Janet Freilich

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand-name counterparts have expired by making slight changes the drug to avoid the brand-name patent. These generics face a paradox: the FDA requires that the generic “not show a significant difference” from the reference product while patent law requires that the generic have “substantial differences” as compared to the reference product. The generic must be bioequivalent but not legally equivalent to the brand-name drug. This paradox occurs frequently in the courts but has never been discussed in the literature. This article analyzes every case involving …

Forging Towards Coexistence, Laurie J. Beyranevand

Laurie J Beyranevand

Abstract: For better or worse, the United States has demonstrated a long history of support for agricultural biotechnology. Justified as necessary to meet the growing demands of our nation’s food demand, federal policies addressing genetic engineering have attempted to balance of set of competing interests to ensure health and safety while also encouraging further innovation and development of technology. The unfortunate effects of these policies are suffered disproportionately by organic and non-GE farmers, as there has been little consideration of how the products of genetic engineering impact this sector. In the midst of regulating biotechnology, the federal government has lost …

Act Up, Fight Back, Fight Aids! The Legacy Of Act Up’S Policies And Actions From 1987-1994, Nathan H. Madson

Nathan H Madson

The AIDS Coalition to Unleash Power (ACT UP) was founded in 1987 after a speech by Larry Kramer implored people to address the widespread destruction and deaths caused by HIV/AIDS. Since its founding, ACT UP has worked to improve the public’s awareness of the disease and to push for legislation that not only protected People With AIDS (PWAs), but also improved their access to medications and treatments. The way in which ACT UP achieved these goals, however, has provided a framework for other marginalized groups to make a similar impact. Some of the tools ACT UP used include: zaps, political …

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq

Vincent J Roth Esq

Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq

Vincent J Roth Esq

Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …