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ABSTRACT: Decades after Roe, debate over abortion remains as contentious as ever. States continue to pass regulations burdening the abortion right, but lack clear guidance on how to evaluate such regulations using the undue burden test. This Article chronicles Supreme Court jurisprudence on abortion and examines how the current circuit split surrounding FDA-protocol legislation fits within the larger framework. Finally, this Article applies the proper version of the undue burden test to FDA-protocol legislation, which resolves the circuit split and provides lower courts with a clear means of analyzing abortion issues moving forward.
In August of 2003, Holly Patterson was a beautiful young girl living in the suburbs of San Francisco. 1 She was an over-achiever who graduated a year early from high school and "enjoyed writing..., loved music, cooking, eating and playing softball and Powder Puff football."2 Tragically, Holly's life must be described in the past tense because Holly Patterson died on September 17, 2003. She was only eighteen years old.3
In the weeks leading up to her death, Holly learned she was pregnant and sought a purely elective medicinal abortion at Planned Parenthood.4 The clinic provided a non-FDA approved dosage of Mifeprex (also known as mifepristone or RU-486) and its companion drug, misoprostol, to terminate her early pregnancy However, Holly experienced severe health complications. This forced her to twice visit an emergency room, which she only walked out of once.5 Holly's untimely death was the result of septic shock, due to endomyometritis, a uterus-related blood infection.6 For Holly, this complication occurred seven days after the termination of her pregnancy was initiated through the use of a non-FDA approved medicinal abortion regimen prescribed to her by Planned Parenthood.7 As her father, Monty, put it, "medical abortion is promoted as safe and effective," however "[t]he information [Holly] was able to obtain about medical abortion cost her life."8
Unfortunately, Holly's story is not as uncommon as one might think. The United States Food and Drug Administration ("FDA") reported in 2011 that 14 women in the United States died from using the mifepristone abortion drug and an additional 2,207 women have been injured by it since the drug's approval in 2000.9 In response to these events, five states passed laws prohibiting the off-label use of mifepristone...