Administrative "health courts" for medical injury claims: the federal constitutional issues

Our article analyzes whether the federal government may constitutionally supplant a traditional system of common-law trials before state judges and juries with new federal institutions designed by statute for compensating victims of medical injuries. Specifically, this article examines the federal constitutional issues raised by various proposals to replace traditional medical malpractice litigation in state courts with a federal system of administrative "health courts." In doing so, we address the following constitutional issues: 1. Is there federal authority to preempt state law (the commerce clause and spending clause issues)? 2. May jurisdiction be created in non-article 3 tribunals, and may claims be decided without trial by jury (the separation of powers and Seventh Amendment issues)? 3. Would pilot programs that require some claims to be pursued in a federal administrative forum while other claimants are left to pursue traditional state tort law remedies be constitutional (the equal protection issue)? The article concludes that a federal compensation system through administrative health courts should be constitutional provided the statute is appropriately drafted and that appropriate factual findings are made concerning the benefits to patients and the public as well as to doctors and their insurers.     

Casting Aside Clanking Medieval Chains: Prerogative,Statute and Article 50 after the EU Referendum

This article confronts the controversies surrounding Article 50 by analysing the relationship between statute and prerogative in the UK. The piece focuses on domestic constitutional issues and suggests a new way of classifying the relationship between statute and prerogative into two types falling under ‘the abeyance principle’ or ‘the frustration principle’. The abeyance principle means that where statute and prerogative overlap, the prerogative goes into abeyance. The frustration principle means that where statute and prerogative give rise to potential inconsistencies, but do not overlap, the prerogative cannot be used inconsistently with the intention of parliament as expressed in the relevant legislation. It then argues that Article 50 has the status of primary or ‘primary‐equivalent’ legislation which could justify applying the abeyance principle. This would mean that the trigger power would be exercised on statutory authority rather than through prerogative powers. If the courts are unable thus to construe the relevant legislation it argues EU law requires the courts to bridge the gap. Alternatively, if the abeyance principle is not applicable, it argues the frustration principle could apply but the circumstances in this litigation fall outside it. In the further alternative, EU law could require the frustration principle itself to be set aside in this case.     

Federal antitrust jurisdiction in peer review cases: the Pinhas decision

In Summit Health Ltd. v. Pinhas, the United States Supreme Court by a narrow majority found that the exclusion of an ophthalmologist from a hospital in Los Angeles had a sufficient effect on interstate commerce to establish federal jurisdiction under the Sherman Act. In resolving a split among the federal circuit courts of appeal, the Court applied the broad jurisdictional test from McLain v. Real Estate Board of New Orleans, Inc. to peer review proceedings. Despite many ambiguities in the majority opinion by Justice Stevens and a scathing dissent by Justice Scalia, the effect of Pinhas will be to increase the suits in federal court on antitrust grounds brought by aggrieved medical staff members and applicants denied appointments or privileges, and to decrease, if not eliminate, the likelihood of preliminary dismissal on jurisdictional grounds. This, in turn, should serve to emphasize the importance of complying with the Health Care Quality Improvement Act in order to obtain immunity from damages under federal antitrust and state laws.     

FDA preemption of drug and device labeling: who should decide what goes on a drug label?

The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label should say. This is in direct contrast to medical devices, where the federal statute regulating medical devices expressly provides that state regulations are preempted. This Article discusses basic preemption principles and drugs, and explores the policy ramifications of pro- and anti-preemption policy in the healthcare industry.     

Jesting at scars that never felt a wound: The US Supreme Court's new doctrine of licensee standing without breach

Until recently, it was assumed that patent licensees in compliancewith terms of their licence agreements would lack ‘standing’to sue their licensors, but in MedImmune v Genentech, the SupremeCourt of the United States held that federal courts in the UShave jurisdiction over declaratory judgment actions by patentlicensees asserting the invalidity, unenforceability, or non-infringementof a licensed patent, even where the licensee is in full compliancewith the licence agreement.     

Neither aider nor abettor be: attorneys become prosecutorial targets for federal healthcare crimes

Attorneys representing healthcare entities are not immune to federal criminal prosecution for the assistance that they give their clients. This Article focuses on potential attorney liability for aiding and abetting a client's violation of law. The author examines the securities, tax, and white-collar crime fields for guidance regarding the interpretation and application of the federal aiding and abetting statute to attorneys practicing in the health law field. Based on these analogous areas, and upon the federal criminal statutes applicable in the healthcare field, he recommends steps that can be taken to minimize the possibility of aiding and abetting liability. In addition, he recommends that the courts require a prosecutorial showing of both actual knowledge of wrong-doing and wrongful intent before imposing aider and abettor liability upon health law practitioners.     

State Courts, the U.S. Supreme Court, and the Protection of Civil Liberties

Advocates of federalism, both in the United States and elsewhere, often cite the potential for enhanced protection of individual civil liberties as an emerging rationale for a federal system dividing governmental responsibilities between central and regional governments and central and regional judiciaries. Echoing this, some judicial officials and scholars, confronting an increasingly conservative U.S. Supreme Court, have called for state supreme courts to use the state constitutional grounds to preserve and increase the protections of the Bill of Rights. Using event count analysis, we examine state search-and-seizure cases for 1981 to 1993 to ascertain under what circumstances state courts would use this opportunity to eliminate Supreme Court review. We find that the relative ideological position of the state supreme courts and the U.S. Supreme Court often prevents, or does away with the need for, liberal courts to use the adequate and independent state grounds doctrine to expand the rights of criminal defendants and that state supreme court justices react more predictably in the assertion of constitutional protection law than the general consensus suggests.     

Is tobacco a drug? Administrative agencies as common law courts

Professor Cass Sunstein argues that the FDA has the authority to regulate tobacco products. He considers the text of the Federal Food, Drug, and Cosmetic Act, which supports the FDA assertion, and the context of its enactment, which argues against the FDA. He resolves the tension between text and context in favor of FDA jurisdiction by turning to the emerging role of administrative agencies. In modern government, he contends, administrative agencies have become America's common law courts, with the power to adapt statutory regimes to new facts and new values when the underlying statute is ambiguous. Professor Sunstein's Article, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising. The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety. The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit.     

TENNESSEE'S ADOPTION LAW

Tennessee has recently enacted legislation increasing access to adoption records, allowing adult adoptees to obtain their birth certificates and other information contained only in their adoption records. After that controversial statute became law, it was challenged in Doe v. Sundquist . After 3 years of litigation, the Tennessee Supreme Court held that the statute was constitutional. The authors discuss the history of Tennessee's adoption law, demonstrating how certain events led to the passing of the controversial statute. They also discuss the adoption triad, including the birth parents, adoptive parents, and adoptees, noting the interests of each party. Following that is a discussion of the Tennessee statute and how it operates. The commentary continues with a detailed look at Doe v. Sundquist , including the procedural and substantive issues in both federal and state court. The authors conclude that the Tennessee law is a practical and reasonable solution to the controversy over sealed adoption records.     

PUNITIVE DAMAGES,CHINESE TORT LAW,AND THE AMERICAN EXPERIENCE

In a country such as China, with abundant consumer products and the inevitability of product defects, claims for punitive damages are sure to arise under Article 47 of the new Chinese Tort Law. Article 47 provides that “(w)hereany producer or seller knowingly produces or sells defective products, causing death or serious damage to the health of others, the injured party may request appropriate punitive damages.” As Chinese jurists and scholars interpret Article 47, they may wish to consider whether lessons can be drawn from the American experience. During the past two decades, few areas of American law have changed more radically than the law on punitive damages. While there were once few restraints on the ability of a judge or jury to impose punitive damages in a case involving egregious conduct, today there are a host of limitations embodied in American state and federal law. In many American states, statutes or judicial decisions restrict the ability of a court to award punitive damages by narrowly defining the types of conduct that will justify a punitive award, raising the standard of proof, capping the amount of punitive damages, requiring a portion of a punitive award to be forfeited to the state, or limiting vicarious liability for punitive damages. In addition, under federal constitutional law, the principle of due process limits the imposition of punitive damages by scrutinizing the ratio between compensatory and punitive damages and prohibiting an award to be based on harm to persons other than the plaintiff. An examination of these developments from a comparative law perspective may prove useful to the implementation of Article 47.     

A moment in human development: legal protection, ethical standards and social policy on the selective non-treatment of handicapped neonates

Selective non-treatment decisions involving severely handicapped neonates have recently come under renewed judicial and legislative scrutiny. In this Article, the Author examines the legal, ethical and social considerations attendant to the non-treatment decision. In Part II of this Article the Author discusses the predominant ethical viewpoints relating to this issue and proposes a new moral standard based on personal interests. Part III presents a survey of the jurisprudence relating to selective non-treatment decisions. Parts IV and V of this Article provide a critical examination of the recently enacted Child Abuse Amendments of 1984, a federal legislative initiative designed to regulate treatment decisions relating to handicapped infants. The Author suggests that the ethical standards and treatment criteria proposed in this Article may prove useful to courts seeking to balance the handicapped neonate's constitutional right to privacy with the requirements of the new federal law.     

From Rogers to Rivers: the rights of the mentally ill to refuse medication

Many individuals with mental illness wish to avoid psychotropic drugs, a type of treatment that may relieve their symptoms only at the risk of unpleasant, even permanent, side effects. In marked contrast to the widely-held view that most patients may refuse any treatment and that even patients with mental illness may reject other psychoactive interventions such as electroconvulsive therapy and psychosurgery, the courts and legislatures have been slow to recognize any right to refuse psychotropic drugs. This Article demonstrates that many of the justifications offered for forcing patients to take unwanted medications are inadequate and that unless treatment refusals are reviewed outside mental institutions, patients' rights will rarely receive appropriate deference. The author analyzes the federal and state litigation to determine whether the courts have fashioned meaningful relief for the mentally ill. The Article concludes that two recent United States Supreme Court decisions have made it impossible for the federal courts to provide adequate protection. By contrast, several state courts have responded to the needs and rights of patients with mental illness.     

Modernizing Medicaid eligibility criteria for children with significant disabilities: moving from a disabling to an enabling paradigm

Children with significant disabilities may qualify for Medicaid benefits, regardless of household income, if their state elects to offer the Tax Equity Fiscal Responsibility Act (TEFRA) option. However, a significant number of children with serious medical problems presently are being denied eligibility for, or terminated from, this Medicaid program. This Article describes the ways in which the existing health insurance system inadequately meets the needs of children with significant disabilities, recounts the history and development of the TEFRA Medicaid coverage option, and analyzes the eligibility criteria used by the various states. It proceeds to consider how disability should be legally defined in the health care context and proposes reforms to modernize the eligibility standards so that these benefits can be more effectively, efficiently, and fairly allocated. To accomplish this goal, the federal statute and regulation that define disability, as well as corresponding state laws, must be reformed so that the law can keep pace with advances in modern medical science, and people with disabilities are not, in effect, penalized for receiving currently accepted preventative care that maintains health but will never cure the underlying disease.     

The Jurisprudence of Constitutional Conflict: Constitutional Supremacy in Europe before and after the Constitutional Treaty

Abstract:  One of the core constitutional questions for national constitutional courts in the EU in the past decades has been whether to accept the claim made by the Court of Justice that EU law is the supreme law of the land, taking primacy even over conflicting national constitutional provisions. With the inclusion in the recently adopted Constitutional Treaty of a clause explicitly confirming the 'primacy of EU Law' appearances suggest that the EU is about to establish a characteristic of mature, vertically integrated, federal states such as the USA. This article argues that this view is mistaken. It develops a comprehensive jurisprudential framework for addressing constitutional conflicts, 'Constitutionalism Beyond the State' (CBC). CBS detaches the discussion of supremacy and constitutional conflict from a statist framework; provides a jurisprudential account that explains and justifies the highly differentiated, context-sensitive and dynamic set of conflict rules that national courts have in the past adopted; and provides the lacking theoretical basis for the more attractive, but undertheorised sui generis accounts of European constitutional practice that have recently gained ground in the literature. CBS provides a jurisprudentially grounded reconstructive account of why the issue of constitutional conflict is as rich and complicated in Europe as it is and why it is likely to remain so even if the Constitutional Treaty is ratified. The article then goes on to make concrete proposals addressed to national constitutional courts and the Court of Juctise respectively about how, in application of the developed approach, constitutional conflicts ought to be addressed doctrinally. It includes a proposal to read the new 'constitutional identity' clause as authorising Member States as a matter of EU Law to set aside EU Law on constitutional grounds under certain circumstances.     

In the Best Interests of an Indian Child: The Indian Child Welfare Act

Before passage of the Indian Child Welfare Act in 1978, state, private, and federal agencies systematically removed Indian children from their families and tribal communities, placing them with non‐Indian families with little appreciation for the detrimental impact that cultural deprivation would have on these children. State courts often ignored the sovereign authority of tribal courts with regard to their children, and were, more often than not, unwilling to acknowledge the importance of the perspective of the child's tribe and/or extended family members. With passage of the Indian Child Welfare Act in 1978, Congress imposed upon state child welfare practices substantive and procedural requirements to which state courts must adhere, most notably the mandate that state courts must now give primary consideration to the placement of Indian children within their extended families and tribal communities. In addition, federal law requires state courts to recognize tribal court authority and jurisdiction over tribal children. This article reviews the history of federal, state, and private practices that propelled Congress to pass the ICWA, the changes that have resulted from this vital legislation, and the challenges that face courts in ensuring that state courts meet these requirements.     

The Purchase of Insurance Across State Lines in the Individual Market

Proposals to allow the purchase of insurance across state lines (PASL) have gained some support in recent years. Health insurers have traditionally been allowed to sell a policy only within the state that approved and regulates that particular policy. PASL would allow insurers to sell a policy approved in one state to people residing in any state. Any federal legislation to enact PASL in an individual insurance market would have to address two main legal considerations: (1) the McCarran-Ferguson Act, which allows the states to retain their regulatory authority over insurance; and (2) a constitutional prohibition against the commandeering of state officials by the federal government. This paper outlines these obstacles and potential solutions, and concludes that as long as the legislation is thoughtfully drafted, there is no significant legal or constitutional barrier to enacting PASL. Additionally, the concepts discussed here may be relevant to any federal health reform legislation involving regulation of health insurance or the use of state officials.     

‘That wicked rule,that evil doctrine … ’: Reforming the Law on Disclosure in Insurance Contracts

The Consumer Insurance (Disclosure and Representations) Act 2012, which abolishes the consumer assured's duty to volunteer information, heralds the first successful outcome of the English and Scottish Law Commissions current insurance contract law reform project. This paper outlines the defects of the common law duty of disclosure which the Law Commissions sought to address. It goes on to consider why previous legislative attempts failed, the self‐regulatory measures introduced by the insurance industry as a means of resisting earlier pressure for statutory intervention, and how that resistance broke down. Finally, it examines the scope of the 2012 reforms and the current consultation being undertaken in respect of the duty of disclosure in relation to business insurance. It concludes by assessing the significance of the statute in providing a necessary impetus for future insurance law reforms.     

Ethics, Law, and Commercial Surrogacy: A Call for Uniformity

In the United States at this time, no uniform federal law exists regarding commercial surrogacy, and state statutory schemes vary vastly, ranging from criminalization to legal recognition with contract enforcement. The authors examine how commercial surrogacy agencies utilize the Internet as a means for attracting parents and surrogates by employing emotional cultural rhetoric. By inducing both parents and surrogates to their jurisdiction, agencies circumvent vast discrepancies in state statutory regulative schemes and create a distinct interstate business, absent an efficient regulatory framework or legal recourse in some circumstances. The authors propose a uniform federal regulatory scheme premised upon regulating interstate business transactions to create accountability and legal remedies for both the parents and the surrogate.     

Fleeting fame under the Trademark Dilution Revision Act of 2006

Legal context: When Congress enacted the Federal Trademark Dilution Act in1996, it intended to create a uniform federal cause of actionfor trade mark dilution. Unfortunately, the statutory languageselected by Congress created certain ambiguities, includinghow famous a trade mark had to be to merit dilution protectionunder the statute. Confusion developed as to whether a markmerely needed renown in a limited geographic area or industry—aconcept that became known as ‘niche fame’—orwhether it needed national renown to qualify as a ‘famousmark’. Key points: In 2006, Congress enacted the Trademark Dilution Revision Actand therein provided a concrete definition for a famous markthat ostensibly removed the ability to qualify for dilutionrelief where the mark was famous only within a particular niche.It was uncertain how courts that had previously favoured theniche fame theory would apply Congress's new definition. However,a district court in the Ninth Circuit, one of the strongestproponents of niche fame, recently held that niche fame is nolonger a viable theory under the Lanham Act or California statelaw as a result of the 2006 amendment. Practical significance: This decision portends that courts will fall in line with Congress'samendment and will deny dilution relief under federal law toparties whose marks are famous only in a particular geographicarea or industry. Additionally, the decision provides some guidanceand predictability as to how states may interpret the viabilityof niche fame under their respective dilution statutes in lightof Congress's 2006 amendment.