Health Law and Policy Commons^™

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system …

Using Clinical Practice Guidelines And Knowledge Translation Theory To Cure The Negative Impact Of The National Hospital Peer Review Hearing System On Healthcare Quality, Cost, And Access, Katharine Van Tassel

Katharine Van Tassel

This Article starts with a history of the growth of hospital peer review and then examines the merits of the rationales that motivated the passage of the Health Care Quality Improvement Act of 1986 ('HCQIA'), which catapulted peer review into the national system that exists today. The Article next explains how the peer review hearing process works and how HCQIA turns private hospitals into small, individual quasi-regulatory agencies. The Article goes on to critique the 'bad apples' approach taken by hospital peer review in light of the growing body of empirical research that supports a systems improvement approach to dealing …

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory …