Law Commons^™

The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski

Faculty Scholarship

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all …

"The Birth Of Death": Stillborn Birth Certificates And The Problem For Law, Carol Sanger

Faculty Scholarship

Stillbirth is a confounding event, a reproductive moment that at once combines birth and death. This Essay discusses the complications of this simultaneity as a social experience and as a matter of law. While traditionally, stillbirth didn't count for much on either score, this is no longer the case. Familiarity with fetal life through obstetric ultrasound has transformed stillborn children into participating members of their families long before birth, and this in turn has led to a novel demand on law.

Dissatisfied with the issuance of a stillborn death certificate, bereaved parents of stillborn babies have successfully lobbied state legislatures …