Digital Commons Network^™

Eaters, Powerless By Design, Margot J. Pollans

Michigan Law Review

Food law, including traditional food safety regulation, antihunger programs, and food system worker protections, has received increased attention in recent years as a distinct field of study. Bringing together these disparate areas of law under a single lens provides an opportunity to understand the role of law in shaping what we eat (what food is produced and where it is distributed), how much we eat, and how we think about food. The food system is rife with problems— endemic hunger, worker exploitation, massive environmental externalities, and diet-related disease. Looked at in a piecemeal fashion, elements of food law appear responsive …

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 …

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

Underbanked: Cooperative Banking As A Potential Solution To The Marijuana-Banking Problem, Patrick A. Tighe

Michigan Law Review

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this “underbanking” problem is a financial cooperative approach such as a cannabis-only …

An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel

Michigan Law Review

Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …

Proving Personal Use: The Admissibility Of Evidence Negating Intent To Distribute Marijuana, Stephen Mayer

Michigan Law Review

Against the backdrop of escalating state efforts to decriminalize marijuana, U.S. Attorneys’ Offices continue to bring drug-trafficking prosecutions against defendants carrying small amounts of marijuana that are permitted under state law. Federal district courts have repeatedly barred defendants from introducing evidence that they possessed this marijuana for their own personal use. This Note argues that district courts should not exclude three increasingly common kinds of “personal use evidence” under Federal Rules of Evidence 402 and 403 when that evidence is offered to negate intent to distribute marijuana. Three types of personal use evidence are discussed in this Note: (1) a …

Regulating By Repute, David Zaring

Michigan Law Review

Is regulation a hopeless cause? Many thoughtful observers spend a lot of time enumerating all of the reasons why it is doomed to fail. The entire field of public choice, with impeccable logic, posits the likely corruption of every bureaucrat. And if corruption cannot explain the failure of regulation, the atrophy that comes from lack of competition-there is just one government, after all, and it does not have a profit motive-may be just as rich a vein to mine. It could also be that the legal system itself, with its myriad complexities, checks, and procedural requirements, may ossify to the …

Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy

Michigan Law Review

In Granholm v. Heald, the Supreme Court held that states must treat instate and out-of-state alcoholic beverages equally under the dormant Commerce Clause and established a heightened standard of review for state alcohol laws. Yet in dictum the Court acknowledged that the three-tier distribution system-a regime that imposes a physical presence requirement on alcoholic beverage wholesalers and retailers-was "unquestionably legitimate." Though the system's physical presence requirement should trigger strict scrutiny, lower courts have placed special emphasis on Granholm's dictum, refusing to subject the three-tier distribution system to Granholm's heightened standard of review. This Note argues that the dictum should be …

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …

One Stop, No Stop, Two Stop, Terry Stop: Reasonable Suspicion And Pseudoephedrine Purchases By Suspected Methamphetamine Manufacturers, Andrew C. Goetz

Michigan Law Review

This Note attempts to inject some clarity into courts' reasonable suspicion calculus for cold medicine purchases. It argues that the key factor in analyzing such purchases is whether the purchaser or purchasers appear to be circumventing pseudoephedrine purchasing restrictions in order to obtain inordinately large quantities of pseudoephedrine. Part I provides a general background on the domestic manufacture of methamphetamine in small, clandestine laboratories. Part II then examines the interplay between outward innocence and reasonable suspicion under the Supreme Court's Fourth Amendment jurisprudence. Finally, Part III establishes a framework for identifying purchasing strategies that methamphetamine manufacturers commonly use to circumvent …

Secondhand Smoke Signals From Prison, Scott C. Wilcox

Michigan Law Review

This Note argues that courts should acknowledge current societal and medical perspectives on second hand smoke (SHS) and afford real protection to prisoners against SHS through injunctive relief. Part I examines evidence that conclusively demonstrates the serious risk of harm posed by SHS to the health of inmates. It reports that inmates' long-term exposure to SHS increases their risk of contracting lung cancer, heart disease, and other potentially life threatening conditions. Part II argues that, as required by the Helling standard, contemporary society does not tolerate involuntary, long-term exposure to SHS and that prison officials exhibit deliberate indifference by allowing …

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

Michigan Law Review

Margaret Berger and Aaron Twerski are among the leading scholars in their respective fields of Evidence and Products Liability. I have benefited from their work on many occasions. Precisely because of the deserved respect and esteem in which Berger and Twerski are held-not to mention the prominence of their forum, the Michigan Law Review-their proposal to create a new "informed choice" cause of action in pharmaceutical litigation is likely to receive sympathetic attention. Because I believe that their proposal is ill-conceived and dangerous, I feel compelled (with some trepidation) to write this response. Berger and Twerski propose that courts recognize …

From The Wrong End Of The Telescope: A Response To Professor David Bernstein, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

On the pages of this law review, in an article entitled Uncertainty and Informed Choice: Unmasking Daubert, the authors argued for the recognition of a new product liability cause of action when drug companies fail to warn about uncertain risks attendant to the use of non-therapeutic drugs whose purpose is to enhance lifestyle. We noted that in the post-Daubert era, plaintiffs have faced increasing difficulty in proving that a given toxic agent was causally responsible for the injuries suffered after ingesting a drug. That plaintiffs cannot overcome the barriers to proving injury causation does not mean that defendants have met …

Uncertainty And Informed Choice: Unmasking Daubert, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

This Article will first examine why it is that plaintiffs have been unable to prove causation under the Daubert guidelines in toxic tort litigation. Second, it will look at the two existing models for informed choice litigation medical malpractice and products liability-and demonstrate why neither of these models gives toxic tort plaintiffs a fair opportunity to recover for the deprivation of patient autonomy against drug manufacturers who have breached their duty to warn of known or knowable risks. Finally, this Article will explore the elements of a causation-free informed choice cause of action. It will suggest the appropriate standard for …

Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone

Michigan Law Review

With The End of History and the Last Man, Francis Fukuyama established himself as the prophet of liberal democracy and free markets, heralding their triumph as the only form of governance capable of commanding legitimacy. Asked to reflect on his predictions a decade later, Fukuyama concluded that the greatest threat to liberalism comes from biotechnology because it alone has the potential to remake the human nature that liberal democracy was designed to serve. Fukuyama makes a compelling case that biotechnology may produce developments that should concern us; he is ironically less persuasive in articulating a liberal-democratic framework for governing the …

Democracy, Science, And Free Trade: Risk Regulation On Trial At The World Trade Organization, Robert Howse

Michigan Law Review

Among the most common critiques of globalization is that it increasingly constrains the ability of democratic communities to make unfettered choices about policies that affect the fundamental welfare of their citizens, including those of health and safety, the environment, and consumer protection. Traditionally, free trade rules were about constraining border measures such as tariffs and quantitative restrictions on imports. Increasingly, however, such rules include requirements and constraints addressed directly to domestic regulation. For example, a country's policies with respect to intellectual property rights or its regulatory approach to network industries, such as telecommunications, may now be fundamentally shaped by rules …

Food Stamp Trafficking: Why Small Groceries Need Judicial Protection From The Department Of Agriculture (And From Their Own Employees), Elliot Regenstein

Michigan Law Review

A neon sign in the window of 7-Van Drugs reads "Food Stamps," but the contradictory truth is posted inside on a handwritten sign taped to a thick pane of bulletproof plastic. 7-Van Drugs sits at the intersection of Seven Mile Road and Van Dyke in northern Detroit, where it has "serv[ ed] the community since 1948 at the same corner." Inside 7-Van is an array of staple foods and basic household cleaning items, and there is a small pharmacy in the back. Customers must use a turnstile to pass their purchases through the bulletproof plastic to the cashier. There are …

When Discretion Leads To Distortion: Recognizing Pre-Arrest Sentence-Manipulation Claims Under The Federal Sentencing Guidelines, Jeffrey L. Fisher

Michigan Law Review

This Note argues that sentence manipulation should be a legally viable partial defense - a defense that does not warrant complete exoneration, but does warrant a reduced sentence when the government's investigative techniques place a quantity of drugs before the court that overrepresents the defendant's culpability, or individual blameworthiness. Part I describes the policies and objectives that underlie the Guidelines, but then demonstrates how the rigid application of quantity-based sentencing provisions can lead to sentence manipulation that thwarts these goals, particularly the goal of sentencing according to culpability. Part II describes how courts have responded to sentence manipulation claims. It …

Voluntary Intoxication: A Defense To Intentional Injury Exclusion Clauses In Homeowner's Policies?, Tracy E. Silverman

Michigan Law Review

This Note argues that the current voluntary intoxication defense to the intentional injury exclusion clause should be modified to allow insurers subrogation rights against insureds who commit intentional acts while voluntarily intoxicated, subject to an exception for alcoholic insureds who successfully complete alcohol treatment programs. Part I discusses the public policy concerns of victim compensation and deterrence and how they influence courts deciding between the three traditional approaches to "intent." Part II analyzes the impact of these intent standards on courts' decisions to allow a voluntary intoxication defense and concludes that the defense as currently formulated promotes victim compensation at …

Beyond The War On Drugs: Overcoming A Failed Public Policy, Kenneth R. Hillier

Michigan Law Review

A Review of Beyond the War on Drugs: Overcoming a Failed Public Policy by Steven Wisotsky

Narrowing The Scope Of Civil Drug Forfeiture: Section 881, Substantial Connection And The Eighth Amendment, James B. Speta

Michigan Law Review

This Note offers two justifications for narrowing the scope of section 881 forfeiture. Part I argues that courts should apply the substantial connection test to section 881 forfeitures. This Part analyzes the statute using the traditional tools of statutory interpretation. While the text of the statute seems to support the broadest possible interpretation, the legislative history and context of adoption suggest that the substantial connection test is consistent with Congressional intent. In amending section 881, subsequent Congresses have favored application of the substantial connection test. Consistent with this narrower reading, present strategy in the "war on drugs" focuses stiff penalties …

Liquor Price Affirmation Statutes And The Dormant Commerce Clause, Ward A. Greenberg

Michigan Law Review

Part I of this Note examines the current state of the law in the liquor affirmation area. Part II argues that the twenty-first amendment may not be invoked to justify the extraterritorial impact of these statutes. The amendment does not preempt the commerce clause in the liquor area. While it gives the states free rein over liquor internally, it provides no basis for any extraterritorial projection of liquor price regulation. Part III considers the commerce clause analysis of Brown-Forman and argues that any interstate effects of these statutes will cause them to violate the commerce clause. This section argues that …

The Heroin Solution, Michigan Law Review

Michigan Law Review

A Review of The Heroin Solution by Arnold S. Trebach

The Hardest Drug: Heroin And Public Policy, Michigan Law Review

Michigan Law Review

A Review of The Hardest Drug: Heroin and Public Policy by John Kaplan

Regulating Carcinogens In Food: A Legislator's Guide To The Food Safety Provisions Of The Federal Food, Drug, And Cosmetic Act, Richard A. Merrill

Michigan Law Review

On March 9, 1977, the Food and Drug Administration (FDA) announced that a study in laboratory rats conducted by the Canadian government confirmed that saccharin is an animal carcinogen. For this reason, the agency stated, the sweetener must be banned from human food.

The studies which Congress mandated, to be accompanied by the recommendations of the Secretary of HEW, are likely to generate a fundamental reexamination of the nation's current food safety policies. This Article attempts to aid this inquiry by explaining the requirements of the present law. The Article describes the several statutory provisions that govern the regulation of …

The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review

Michigan Law Review

Two judicial decisions in the early 1950s construing the FTC's section 13 (a) power produced a conflict that has not been resolved either by later courts or by the amendments to section 13 enacted in 1973. The dispute basically concerns the depth of the courts' inquiry into whether an advertisement violates- section 12 and the applicability of traditional equitable concepts in the context of the statutory injunction procedure. This Note contends that the legislative history of pertinent provisions of the Act suggests an appropriate resolution of the conflict through a two-step approach that would relax the scrutiny ordinarily accorded petitions …

Products Liability Based Upon Violation Of Statutory Standards, Joseph H. Ballway Jr.

Michigan Law Review

Regulatory enactments controlling production and distribution can give rise in several different ways to civil liability on behalf of persons injured by non-conforming merchandise. For instance, if a statute codifies existing common-law rules of negligence, its effect is merely to place the weight of legislative authority behind ordinary negligence principles. Since an injured party's recovery under such a provision still depends largely upon his proving in the traditional manner that a defendant failed to exercise due care, this kind of statute merits no further discussion. On the other hand, if particular legislation expressly states that a violator may be subjected …

Alcoholism And The Law, Melvin L. Selzer

Michigan Law Review

The American public has recently been subjected to a deluge of articles and books on the subject of alcoholism. While these contributions have been filled with valuable information, certain omissions have been noticeable. These omitted facts are of vital significance to any one wanting to gain insight into the broad problem of alcoholism. The first omission is a failure to stress that no one-or almost no one-knows who is alcoholic. This may include the alcoholic himself. It is a point of considerable importance in determining the proper disposition of certain criminal cases.

Federal Procedure-Appeal Under Federal Food, Drug & Cosmetic Act--Scope Of Admiralty Appeal Compared With Appeal Under The New Federal Rules, De Witte Chatterton

Michigan Law Review

Appellee, the United States government, by a proceeding in rem, sought to condemn two shipments of canned oysters packed by appellant, the C. C. Company, under the Federal Food, Drug and Cosmetic Act, on the ground that the oysters were wholly or partially decomposed. The district court found for the appellee on conflicting evidence of experts, and appellant appealed to the Circuit Court of Appeals for the Fifth Circuit. On the theory that procedure on appeal should conform to appeals in admiralty, the circuit court of appeals reviewed the whole case de novo, reversed the district court on the ground …

Constitutional Law - Commerce Clause - Regulation Of Renovated Butter Manufacture, Michigan Law Review

Michigan Law Review

Plaintiff, who was engaged in the manufacture of renovated butter from packing stock butter, brought an action to enjoin Alabama officials from enforcing state laws relating to the inspection and seizure of the raw material. Plaintiff contended that since the production of renovated butter was taxed and regulated by the United States, state action was excluded. The federal act conferred upon the Secretary of Agriculture, among other things the duty of ascertaining "whether or not materials used in the manufacture of said process or renovated butter are deleterious to health or unwholesome in the finished product, and in case such …