Is There A Doctor in the House? Using Failure-to-Warn Liability to Enhance the Safety of Online Prescribing

This Note argues that manufacturers can satisfy the duty to warn that is owed to consumers who purchase prescription medications from Internet prescribing sites by contractually obligating the websites to implement comprehensive patient information systems. Analyzing these systems under a traditional failure-to-warn liability framework will allow reputable sites to mature into reliable sources of prescription medications for consumers, while cutting off the supply of drugs to fraudulent sites without resorting to increased government regulation. Ideally, this framework wiIl force manufacturers to weigh patients\u27 health and safety with the commercial and practical advantages of Internet prescribing. Part I of this Note chronicles the rise of Internet prescribing and the increased access to prescription medications it offers the everyday consumer. Part II outlines the learned intermediary doctrine and discusses why it is inapplicable to current online prescribing practices. This Part also describes the unique difficulties pharmaceutical manufacturers face when trying to implement a direct warning system, but concludes by arguing that these difficulties should not dissuade manufacturers from exploring online prescribing. Part III presents a solution for conveying adequate patient warnings directly to the patient, taking into account the unique challenges that Internet prescribing presents. This Part proposes that the application of a traditional failure-to-warn analysis will enable manufacturers to use the Internet to create comprehensive patient information systems that satisfy manufacturers\u27 duty to warn in an online prescribing situation. There are two ways this might be accomplished: first, by enhancing the online physician-patient relationship so that it falls within the confines of the learned intermediary doctrine, or second, by implementing Individualized Patient Reports (IPRs) without increasing the physician\u27s role in the transaction, thus spurning the protection of the learned intermediary doctrine completely. Finally, this Part proposes that manufacturers, and not the government, must require web sites to implement either of these systems in order to ensure the success of these patient safety measures

Assigning the Burden of Proof in Contractual Jury Waiver Challenges: How Valuable Is Your Right to a Jury Trial?

Employers have long used arbitration agreements to manage the risk associated with the resolution of employment disputes. But as dissatisfaction with arbitration increases, employers are fundamentally changing their approach to dispute resolution by incorporating jury waivers into their employment agreements as an alternative. These jury waivers are an attractive compromise between arbitration and jury trials because they offer the full procedural protections of the public judicial system at a considerably lower cost than a comparable jury trial. Some courts have invalidated such jury waivers, however, making the enforcement of such waivers uncertain. In order for pre-dispute jury waivers to be used effectively, this uncertainty must be addressed and resolved. In this Article, Chester Chuang surveys the law surrounding the use of pre-dispute jury waivers in employment agreements and traces the inconsistent judicial treatment of such waivers to a disagreement over which party bears the burden of proof when such waivers are challenged in court. Chuang argues that strong public policy considerations support placing the burden of proof on the party seeking to enforce the waiver. Chuang concludes that resolving the burden of proof question in this way will allow such waivers to be used to mitigate risk when appropriate

Patenting Human Genes: The Myriad Controversy

The controversy over human gene patents was reignited in March 2010 when a US Federal District Court decided that isolated human gene sequences are not patentable. An appeal is pending, although the US Department of justice filed a friend-of-the-court brief in the case in late October, arguing that such gene sequences should not be patentable. Because this case may eventually find its way to the US Supreme Court, the ruling could have significant implications for gene-based medical therapies and for the biotechnology industry overall. It is therefore important to assess both the past and present context of this controversy, taking into account scientific research, health care access, and ethical concerns

The Pros and Cons of Gene Patents

The debate over human gene patents was recently reignited by New York federal Judge Robert Sweet, when he found isolated human gene sequences unpatentable in Association for Molecular Pathology v. U.S. Patent and Trademark Office , 702 F.Supp.2d 181 (S.D.N.Y. 2010). An appeal of the decision is pending, and in October, the U.S. Department of Justice filed an amicus curiae brief in the case arguing that such gene sequences should not be patentable, contradicting long-standing practices of the United States Patent and Trademark Office. Given the potent impact of a possible gene patent ban on gene-based medical therapies and the biotechnology industry at large, the arguments for and against patenting human genes must be carefully considered. Unfortunately, much of the current legal debate has centered on technical aspects of patent law doctrine and not the significant policy arguments that also need to be resolved. It is therefore important to evaluate the issue in a fuller context, taking into account health care access, scientific research and ethical concerns

Patenting Human Genes: The Myriad Controversy

The controversy over human gene patents was reignited in March 2010 when a US Federal District Court decided that isolated human gene sequences are not patentable. An appeal is pending, although the US Department of justice filed a friend-of-the-court brief in the case in late October, arguing that such gene sequences should not be patentable. Because this case may eventually find its way to the US Supreme Court, the ruling could have significant implications for gene-based medical therapies and for the biotechnology industry overall. It is therefore important to assess both the past and present context of this controversy, taking into account scientific research, health care access, and ethical concerns

The Pros and Cons of Gene Patents

The debate over human gene patents was recently reignited by New York federal Judge Robert Sweet, when he found isolated human gene sequences unpatentable in Association for Molecular Pathology v. U.S. Patent and Trademark Office , 702 F.Supp.2d 181 (S.D.N.Y. 2010). An appeal of the decision is pending, and in October, the U.S. Department of Justice filed an amicus curiae brief in the case arguing that such gene sequences should not be patentable, contradicting long-standing practices of the United States Patent and Trademark Office. Given the potent impact of a possible gene patent ban on gene-based medical therapies and the biotechnology industry at large, the arguments for and against patenting human genes must be carefully considered. Unfortunately, much of the current legal debate has centered on technical aspects of patent law doctrine and not the significant policy arguments that also need to be resolved. It is therefore important to evaluate the issue in a fuller context, taking into account health care access, scientific research and ethical concerns

9th Annual Conference on Recent Developments in Intellectual Property Law & Policy

Conference agenda and booklet

9th Annual Conference on Recent Developments in Intellectual Property Law & Policy

Conference agenda and booklet