By Tim Welch
A group of families is suing the Minnesota Department of Health (MDH) for violating a 2006 genetic privacy statute that includes an informed consent provision for collecting genetic information. The plaintiffs allege that MDH has taken blood samples from their newborn babies without their consent, tested the blood for various disorders, kept the blood samples in storage instead of destroying them, and shared the samples with various private entities and hospitals. The plaintiffs allege that Minnesota state law (Minn. Stat. §13.386) prohibits MDH from "collecting, storing, using, and disseminating blood and genetic information." In collecting and testing these blood samples, MDH is complying with another Minnesota law (Minn. Stat. §144.125) that requires the mandatory testing of newborns (called "newborn screening") for certain genetic diseases.
Minnesota is not the only state to require the genetic testing of newborn babies for hereditary diseases. In fact, all states require testing for phenylketonuria (PKU) and congenital hypothyroidism. Testing for PKU is generally considered justified, since a newborn diagnosed with PKU must immediately follow a strict diet, or suffer irreparable brain damage. The number of diseases tested for ranges across the country from 4 to 32. States decide which diseases to test for based on several criteria, including benefit to the newborn, validity and reliability of the test results, and safety and effectiveness of treatment.