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Online Edition Articles - Biotechnology
Recent Development: Sherley v. Sebelius: A Call to Congress to Explicitly Support Medical Research on Human Embryonic Stem Cells
NC JOLT Online Edition, Volume 12, Page 77 (December 2010)
Abstract
Progressive biomedical research is the key to developing new and effective treatments for many of the diseases and conditions that afflict our society. The scientific community is in agreement that human embryonic stem cell research is a field that holds great promise. The recent federal district court opinion in Sherley v. Sebelius threatens to derail the progress of science and the hope of millions by denying federal funding of this research based on an appropriations rider known as the Dickey-Wicker Amendment. While the rider’s plain language bans federal funding of any research that creates or destroys embryos, it has been accepted for over a decade that the government may fund research on stem cell lines that are obtained through private funding. With an uncertain outcome pending in the Court of Appeals, it will be argued that the Dickey-Wicker Amendment should be amended or repealed to give effect to the longstanding practice by the National Institutes of Health of funding human embryonic stem cell research within ethical guidelines. Furthermore, Congress should make it a priority to pass the Stem Cell Research Advancement Act in order to explicitly support the efforts of scientists working with human embryonic stem cells to develop groundbreaking medical advances.
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Recent Development: Baby Mama Drama: Parentage in the Era of Gestational Surrogacy
NC JOLT Online Edition, Volume 11, Page 233 (June 2010)
Abstract
Although recent decades have seen a boom in the development of technologies that manipulate the human reproductive cycle, many states have been slow to adopt laws regulating third-party reproduction. While a handful of states recognize the validity of gestational surrogacy contracts, others find such contracts to be against public policy. Most states’ statutes, however, are silent on third-party reproduction. Improving technologies will continue to open the door to more reproductive breakthroughs and the surrogacy industry will invariably grow. Infertile individuals will increasingly turn to what they consider a valuable and necessary service to fulfill their dream of having a family. States must take steps to legalize third-party reproduction, regulating it so that both the rights of intending parents and the best interests of the children produced through contractual arrangements receive adequate protection. States should model such statutes on Article 7, Alternative B of the American Bar Association’s Model Act Governing Assisted Reproductive Technologies, which respects the intentionality of intending parents and includes common-sense safeguards to reduce litigation and protect the best interests of children created through third-party reproduction.
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Recent Development: New Rules, Different Risk: the Changing Freedom to Operate Analysis for Biotechnology
NC JOLT Online Edition, Volume 11, Page 139 (June 2010)
Abstract
Patent protection has evolved since the inception of the Federal Circuit in 1982. Mandated to unify the fractured application of the patent laws, the Federal Circuit initially set out to reinforce the protections guaranteed to patented inventions. For the first couple of decades the Federal Circuit succeeded in strengthening the patent system. Recently however there has been a definite shift in this trend with efforts by the Supreme Court, Federal Circuit, and Congress to both raise the bars to patentability and limit some of the earlier protections granted, particularly to biotechnology patents. Patents are now more likely to be invalidated under the new stricter patenting standards, and the narrower patents that will survive these new standards will have less enforcement capabilities owing to the weakening of many of the patent remedies available to patentees. Overall, these efforts will change the freedom-to-operate calculus of both patentees and putative infringers. This Article reviews these recent changes.
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Recent Development: Riegel v. Medtronic in Light of the Recent Trend in Preemption Cases: A Case for Amending the Medical Device Act
NC JOLT Online Edition, Volume 11, Page 27 (December 2009)
Abstract
The Medical Device Act of 1976 governs the Food and Drug Administration’s premarket approval process for medical devices. In Riegel v. Medtronic, Inc., the United States Supreme Court held that the Act preempts state tort claims against medical device manufacturers. This Recent Development contends that the Court appropriately decided Riegel in light of its recent trend towards amore textual approach to statutory interpretation in federalism cases in the administrative context. Post-Riegel decisions ,however, are improper in view of legislative intent and unfavorably deprive plaintiffs of state tort remedies. Congress should now amend the Medical Device Act in order to clarify its purpose and to produce the effect originally intended.
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Recent Development: Markovich v. Secretary of Health and Human Services: An Ounce of Cure for a Pound of Prevention
NC JOLT Online Edition, Volume 10, Page 59 (January 2009)
Abstract
There’s an old saying that “an ounce of prevention is worth a pound of cure.” Vaccinations seem to exemplify this, allowing people to avoid diseases entirely by submitting to a simple injection, rather than forcing them to worry about the more difficult alternative of treating the disease once it is contracted. Markovich v. Secretary of Health and Human Services is a case in which an infant suffered severe injuries resulting from a vaccination. To address such rare situations, the National Childhood Vaccine Injury Act establishes a system through which injured parties may recover medical costs from the government. This Recent Development examines a failure of that system to serve its intended purpose. It looks at ways in which the court’s decision in Markovich runs counter to the policies underlying the creation of the system. It also considers the court’s erroneous interpretation of statutory language and the injustice of denying compensation to infants injured by vaccines that results from this misapplication. Markovich illustrates how the few children injured by vaccines may be offered precious little financial restitution for the unintended consequence of a technology that keeps the rest of us healthy.
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Recent Development: Running Down a Dream: Oscar Pistorius, Prosthetic Devices, and the Unknown Future of Athletes with Disabilities in the Olympic Games
NC JOLT Online Edition, Volume 10, Page 16 (November 2008)
Abstract
Oscar Pistorius, a double-amputee sprinter set on competing in the Olympic Games, was banned from competition by the International Association of Athletics Federation (“IAAF”) after it found his prosthetic legs gave him an unfair advantage over other runners. On appeal, the Court of Arbitration for Sport held that Pistorius had no such advantage, but the court’s ruling was limited only to Pistorius and his specific prosthesis. This Recent Development describes how the court’s ruling imposes substantial burdens on both athletes with disabilities and the IAAF. This Recent Development also discusses why the IAAF is not in the best position to enforce the ruling, and it enumerates remedies the IAAF can implement to resolve eligibility questions when evaluating athletes with disabilities.
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