Medical Jurisprudence Commons^™

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

12 Angry Men V. The Agency: Why Preemption Should Resolve This Conflict In Drug Labeling Litigation, Michelle L. Richards

Marquette Law Review

The Supreme Court has found in favor of preemption in tort liability cases involving matters of heavy federal regulation in which Congress has delegated implementation of a statute involving technical subject matter to the agency. It has not been the case, however, in matters concerning the labeling of prescription drugs, despite the fact that the FDA has exclusively regulated drug labeling for more than a century. In fact, the current state of affairs now allows a jury to substitute the judgment of the FDA in approving a label on a name-brand drug for their own in state law failure to …

Is It Time To Pay Attention? Critiquing The Cognitive Enhancement Drug Policies And Appeals Process In United States Collegiate Sports, David Swiedler

Cardozo Journal of Conflict Resolution

This Note examines PED use in college sports, focusing primarily on cognitive enhancing drugs as an example of a common lethal PED, and the current NCAA drug-testing regulations and disciplinary process to explore its efficiency and fairness. Then, the Note proposes changes to the NCAA protocol, specifically changes to the appeals process for student-athletes who fail drug tests for PED use and request a review of the disciplinary actions taken against them by the NCAA.

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Mending Invisible Wounds: The Efficacy And Legality Of Mdma-Assisted Psychotherapy In United States' Veterans Suffering With Post-Traumatic Stress Disorder, Jonathan Perry

Journal of Law and Health

Though Veteran Affairs has provided crucial life sustaining—and often lifesaving—treatments to returning soldiers, the substantial and ever-increasing rates of veteran suicides, drug addictions, and criminal behavior indicate a need for broader options in treatment. One of the most profound discoveries uncovered through MDMA-assisted psychotherapy research is MDMA’s facilitation of the alleviation of addictive behavior in subjects, and, as a result, an alleviation of addictions in general. Addiction is one of the key symptoms of post-traumatic stress disorder (PTSD) and drug abuse plays a large role in the other afflictions suffered by veterans, namely criminal activity and a high rate of …

The Death Penalty Experiment: State-Sanctioned Laboratories Of Death, Steffi Yellin

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

Decline Of Dosage Regimen Patents In Light Of Emerging Next-Generation Dna Sequencing Technology And Possible Strategic Responses, Na An

Minnesota Journal of Law, Science & Technology

No abstract provided.

The Negative Effects Of Cumulative Abortion Regulations: Why The 5th Circuit Was Wrong In Upholding Regulations On Medication Abortions (Planned Parenthood Of Greater Texas Surgical Health Services V. Abbott), Benjamin A. Hooper

University of Cincinnati Law Review

No abstract provided.

The Pharmaceutical Access And Prudent Purchasing Act Of 1990: Federal Law Shifts The Duty To Warn From The Physician To The Pharmacist, Michael J. Holleran R.Ph.

Akron Law Review

This article will first discuss the legislation recently enacted as part of the budget reduction package passed by Congress in late 1990 and how that legislation will affect pharmacists' liability. Second, the article will address the applicable statutes of limitation regarding pharmacists in particular and within the general area of malpractice. Third, the applicable standard of care will be explored as it pertains to pharmacists as well as physicians. Coupled with the standard of care discussion is an overview of the various theories of liability which physicians and pharmacists currently face and how these may change under the Act. Finally, …

The Little “Black” Pill: Dressing Unlikely Murderers For Defense Success, 48 J. Marshall L. Rev. 933 (2015), Cassandra Wich

UIC Law Review

No abstract provided.

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …

Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar

Vanderbilt Journal of Entertainment & Technology Law

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …

Who's Swallowing The "Bitter Pill"?: Reforming Write-Offs In The State Of Washington, Lauren M. Martin

Seattle University Law Review

Washington’s application of the collateral source rule permits recovery for medical expenses that were never incurred and have no relationship to their market value. This application is set forth in Hayes v. Wieber Enterprises, Inc., where the plaintiff sued a restaurant for injuries she sustained from falling down the restaurant’s basement stairs. Why should the collateral source rule compel the defendant in Hayes to pay the original amount billed, $5,800, when the physician accepted $3,300 as payment in full? Is not $3,300 the reasonable or market value of the medical services provided to the plaintiff? This Comment discusses whether Washington …

Gene Patents In The Wake Of Association For Molecular Pathology V. Myriad Genetics, Inc.: An International Perspective On Pharmacogenomics, Stephanie S. Lim

Cardozo Journal of International and Comparative Law

Now that the Supreme Court of the United States has held that isolated DNA fragments are not patentable subject matter under 35 U.S.C. §101 in Association for Molecular Pathology v. Myriad Genetics, Inc., thousands of existing isolated gene patents can be invalidated. In the European Union, by contrast, patent protection for human genetic sequences has always been strong and the BRCA gene patents at issue in Myriad are still valid in the European Union. It remains to be seen how the differential gene patent protection regimes in these developed nations will affect the biotechnology industry.

This Note poses that question …

High Time For Medical Marijuana Or Buzz-Kill?: The Controlled Substances Act And The Sherman Antitrust Act May Cause Florida's Compassionate Medical Cannabis Act To Go Up In Smoke, Thu Pham

Florida A & M University Law Review

Florida is the latest state to jump into the arena of medical marijuana with the passage of SBI030 on June 16, 2014. The law, named The Compassionate Medical Cannabis Act of 2014,' allows low-THC cannabis to be prescribed to patients suffering from cancer or physical medical conditions that chronically produce symptoms of seizures or severe and persistent muscle spasms.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Failing To Warn In The Context Of Rare Side Effects, Morris Dweck

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler

Pepperdine Dispute Resolution Law Journal

The article presents information on the Vaccine Injury Compensation Program. It discusses the U.S. Federal circuit case Hazlehurst v. Sec'y of Health & Human Servs., in which lawsuit against the defendant was filed by the plaintiff who sought claims against the liability of product to recover damages for alleged injuries which his son had received from vaccines. It also provides information on the structural moral hazard of the program which devolves it into a litigious adjudicatory process.

No Duty To Warn Of Drug Interactions: A Dangerous Prescription, 46 J. Marshall L. Rev. 533 (2013), Ryanne Bush Dent

UIC Law Review

No abstract provided.

When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder

Articles, Book Chapters, & Popular Press

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …

Preemption Under The Controlled Substances Act, Robert A. Mikos

Vanderbilt Law School Faculty Publications

States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …

Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff

Pepperdine Law Review

No abstract provided.

Vaccines And The Law, Michael Sanzo Ph.D.

Pepperdine Law Review

The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required …

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Medicines That Kill, Lina Ahmed Abushouk

Annual Undergraduate Conference on Health and Society

The prevalence of counterfeit drugs on the African continent has been increasing at an alarming rate. “Medicines that Kill” is a research paper that attempts to analyze the factors that make African countries particularly susceptible to this global threat. Nigeria, a country that has had some of the highest rates of counterfeit drugs in the world, is the main case study for this paper. Its efforts to combat the issue are compared and contrasted with those of Tanzania and Kenya in an attempt to understand what aspects of the issue are unique to Africa and the methods that have been …

Doctors, Patients, And Pills - A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Cardozo Law Review

This Article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century; and regulatory necessity due to the limits of science and the innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based on genetic expression). Although both factors have changed immensely, the standard for drug approval …

Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson

University of Michigan Journal of Law Reform Caveat

Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused …

Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer

UIC Law Review

No abstract provided.

The Physician Payment Sunshine Act: An Important First Step In Mitigating Financial Conflicts Of Interest In Medical And Clinical Practice, 45 J. Marshall L. Rev. 963 (2012), Alexandros Stamatoglou

UIC Law Review

No abstract provided.