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68 Stan. L. Rev. Online 1 (2015-2016)

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                        68 STAN. L. REV. ONLINE 1
                               May 4, 2015




       SAFE AND EFFECTIVE FOR HUMAN

                        EXECUTIONS?

      GLOSSIP V. GROSS AND THE EIGHTH

  AMENDMENT BAR AGAINST OFF-LABEL

              DRUG LETHAL INJECTION


                     Rose Carmen Goldberg*

                             INTRODUCTION

    In June1 the U.S. Supreme Court will decide Glossip v. Gross, a challenge
to Oklahoma's lethal-injection protocol brought by three death row inmates.2
The inmates argue that the protocol's first drug, midazolam, violates the Eighth
Amendment's prohibition against cruel and unusual punishment because it does
not reliably induce unconsciousness. Midazolam's inadequacy, they claim,
could result in severe pain during the protocol's death-inducing phase.3 Most
relevantly midazolam  is not FDA   approved as a stand-alone anesthetic,4
meaning its use in lethal injections is off-label. I argue that off-label drug use
in lethal injections raises significant Eighth Amendment questions and that the
Court should invalidate the protocol at issue in Glossip because of its lack of
FDA approval. Although courts are increasingly recognizing the constitutional



      * J.D. Candidate, Yale Law School, 2015; M.P.A., Columbia University, 2008.
Many thanks to Dr. Aaron Kesselheim of Harvard Medical School/Brigham and Women's
Hospital for his invaluable guidance and to the editors of the Stanford Law Review for their
excellent editorial support.
      1. See Description of Death Penalty Cases Heard by the Supreme Court in the 2014-
2015 Tem, DEATH PENALTY INFO. CTR., http://www.deathpenaltyinfo.org/united-states
-supreme-court-decisions-2014-2015-tem (last visited Mar. 17, 2015) (Glossip will be
argued in April and likely decided by the end of June.).
      2. Glossip v. Gross, No. 14-7955 (U.S. argued Apr. 29, 2015).
      3. Warner v. Gross, 776 F.3d 721, 727 (10th Cir. 2015) (quoting Record, Vol. 1, at
963) (internal quotation mark omitted), cert. granted, 135 S. Ct. 1173 (2015).
     4. See Roche Pharm., Package Insert for Versed (dated 1999), available at
http://www.fda.gov/ohrms/dockets/dailys/01/MarO1/032101/cpOOOO- exhibit 02.pdf (listing
midazolam's FDA-approved use as induction of general anesthesia, before administration
of other anesthetic agents). Midazolam, trade name Versed, is the only anesthetic in the
lethal injection protocol in Glossip.

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