Plaintiff suspects that a chemical in her city’s water supply has caused her to develop a rare form of liver cancer. Defendant, a company in Plaintiff’s city, has been discharging the chemical into the water for a number of years. Both parties in the toxic tort litigation are at the mercy of an unevenly developed and often insufficient body of science to establish or rebut the required causation element.

This article will examine the current causation paradigm in toxic tort litigation, pointing out its specific weaknesses. The article will then introduce an emerging discipline, toxicogenomics, which will eventually make it possible to specifically describe the molecular pathways leading from exposure to injury, and in so doing will greatly improve the reliability of causation evidence in toxic tort cases to the benefit of both plaintiffs and defendants. To illustrate its potential usefulness, this article will walk through a hypothetical toxicogenomics experiment involving a suspected liver toxin. The article will conclude by suggesting that judges controlled by Daubert v. Merrell Dow Pharmaceuticals, Inc. would be wise not to admit such evidence until more research can definitively link the described molecular pathways to the specific injury.

Cite as 5 N.C. J.L. & Tech. 33 (2003) | Download PDF

The Presidential election of 2000 forever will be known as one of the most highly contested elections in United States’ history. After the final tally, a mere 537 votes decided the presidency. One of the key issues at the heart of the election was the high cost of prescription drugs, especially for senior citizens. Both candidates hoped to lower prescription drug prices and, at the same time, facilitate the entry of generic drugs into the marketplace to drive down prices. Coincidentally, nearly twenty years earlier, Congress faced a similar debate. That debate led to the creation of The Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman Act”), which dramatically affected the patent and food and drug laws as well as the manner in which the pharmaceutical industry operated.

Generic drug manufacturers perform bioequivalency testing to ensure that the generic drug contains the same amount of active ingredient as the patented drug. To this end, Congress enacted 35 U.S.C. § 271(e)(1), which created a safe harbor by exempting from infringement all conduct “reasonably related to the development and submission of information” necessary to obtain regulatory approval. As a result, it was estimated that, by the end of 2002, generic drugs would account for over two-thirds of all prescriptions written and approximately twenty billion dollars in retail.

This Recent Development examines the Federal Circuit’s recent decision in Integra Lifesciences I, Ltd. v. Merck KGaA and argues that the Federal Circuit properly narrowed the scope of the exemption provided by the § 271(e)(1) safe harbor provision. Additionally, this Recent Development proposes that the Supreme Court should grant certiorari and affirm the Integra decision because it is consistent with the legislative intent of § 271(e)(1). Moreover, this Recent Development proposes that Congress should enact a statute codifying the common law research exemption to bring the state of patent law in accord with twenty-first century principles.

Cite as 5 N.C. J.L. & Tech. 59 (2003) | Download PDF

Competing visions of a Medicare prescription drug benefit often differ dramatically in their treatment of low-income groups. The profound implications of this treatment spread far beyond access to medical care, even reaching the process of technological innovation through which new drugs are produced. Low-income subsidies3 under proposed versions of the Medicare prescription drug benefit will significantly alter the incentives pharmaceutical manufacturers face, possibly resulting in the unexpected emergence of more innovative drugs from the R&D process as research focuses on the special needs of low-income groups.

The different prescription drug benefit proposals highlight the impact of law and policy in shaping the course of science, healthcare, and the socioeconomic status of Americans. Among the many economic consequences of such a benefit, significant changes will occur in the technological innovation of new drugs as manufacturers respond and adapt to a different marketplace. Evidence suggests that two primary forces will drive research toward more innovative outcomes. First, better access to drugs for low-income Medicare beneficiaries will increase drug demand and ease financial pressure on pharmaceutical producers to boost profits via minor variations of existing product lines.6 Second, for a variety of reasons, aging low-income groups tend to be in poorer health than their higher-income peers, resulting in greater demand for technologically complex drugs.

Cite as 5 N.C. J.L. & Tech. 81 (2003) | Download PDF

Since the adoption of the Digital Millennium Copyright Act (“DMCA”) in 1998, the courts have failed to fully define the scope of which copyrighted works are protected by the anticircumvention provisions. Courts have struggled to define this scope because Congress promulgated the DMCA in the context of promoting commerce over the Internet. Congress, however, drafted the DMCA anti-circumvention provisions with such broad and arguably unambiguous language5 that courts have been hardpressed to limit the application of the provisions to Internet commerce. Yet, not until Lexmark International, Inc. v. Static Control Components had a court interpreted the scope of the anticircumvention provisions as broad enough to protect purely functional, not independently marketed, copyrighted works.

This Recent Development uses Lexmark as a case study and comes to the conclusion that although the anti-circumvention provisions seem to apply to the Lexmark facts courts should not allow plaintiffs to use the anti-circumvention provisions to protect purely functional and not independently marketed copyrighted works because doing so leads to outcomes that are contrary to public policy.

Cite as 5 N.C. J.L. & Tech. 101 (2003) | Download PDF

An employee arrives at work, logs onto Hotmail, types a quick message to his wife, sends a quick e-mail to friends about catching tonight’s game at the bar, and forwards the latest joke that is a little risqué. This type of e-mail use is common in corporate America among employers of all sizes. However, use of personal e-mail at work is no minor distraction. Consider an average size company of 1,000 employees—if the employees spend only one hour of each day on the Internet or using e-mail, the cost to the company could be greater than $35 million dollars in lost productivity in one year. Major companies such as Xerox, the New York Times, Chevron, and Microsoft have been forced either to fire employees or settle lawsuits relating to e-mail use at work. Recently, employees have shifted to using personal, web-based emails at work. Recognizing these problems, employers are now using surveillance software, known as “spyware,” that can “capture every keystroke a user types at a computer, or take screen shots at regular interval[s] of everything a computer user does. [This] include[s] logging Web-based e-mail activity.”

This Recent Development focuses on a specific type of surveillance: private employers’ monitoring of their employees’ personal webmail accounts, such as Yahoo or Hotmail. First, this Recent Development reviews two recent district court decisions that involve employee use of web-based e-mail accounts at work. The Recent Development then argues that given the unsettled state of the law of employer e-mail surveillance of webmail, the courts should expand the laws allowing employer monitoring to explicitly include personal employee webmail accounts accessed by employees on company computer networks or Internet connections. Finally, this Recent

Cite as 5 N.C. J.L. & Tech. 121 (2003) | Download PDF

Many articles have explored the explosive growth of Internet gambling. As of August 2000, over forty percent of American homes has access to the Internet, and an estimated 4.5 million Americans had already gambled online at least once. Some ambitious forecasts predict that by the year 2006, Internet gambling will become a $100 billion a year industry.

Not surprisingly, the appropriate stance on online gambling has been a frequent topic of scholarly debate. A popular trend in existing literature is to compare the two most likely policy responses to Internet gambling in the United States: should it be prohibited, or should we attempt to regulate it in some way? This article begins with the assumption that in either case an effective enforcement scheme will be vital to the policy’s success.

To that end, this Comment examines two existing regulatory systems in an attempt to extrapolate possible characteristics of a comprehensive plan to deal with Internet gambling. The first model is the regulation of online securities trading by the Securities and Exchange Commission (“SEC”). The analysis then shifts to the enforcement of consumer protection laws in cyberspace by the Federal Trade Commission’s Bureau of Consumer Protection (“BCP”). The intent of this article is not to educate the reader about the substantive law underlying either securities regulation or consumer protection. The intent is to identify techniques that regulators have employed to meet the unique challenges of regulation and law enforcement on the Internet. Finally, the article determines which, if any, of those techniques could be adapted to the context of online gambling.

Ultimately, the regulatory scheme of the SEC proves the more attractive model. A permissive regulatory environment encourages cooperation from website operators, provides incentives for operators to locate within the United States, and narrows the range of police duties shouldered by regulators.

Cite as 5 N.C. J.L. & Tech. 155 (2003) | Download PDF