Newborn Blood Spot Litigation: 70 Days to Destroy 5+ Million Samples
Sometime in the next few months, Texas will destroy more than 5 million blood samples collected from newborn babies across the state over the past seven years. The lawsuit that led to this result—agreed to as part of a settlement reached between the state and a civil rights group representing a group of parents—illustrates a number of interesting points about the law and litigation of genetics issues.
As we discussed in A Closer Look at Biobanking of Newborn Blood Spots, states collect blood samples from most infants born in the United States each year, with the goal of detecting and treating a variety of potentially serious conditions. The Texas Department of State Health Services (DSHS) has been collecting newborn blood samples from babies born within the state since the 1960s. Texas currently tests for conditions including cystic fibrosis, endocrine disorders, fatty acid disorders, and others—28 disorders in all (pdf). At least some of the samples are apparently subjected to genetic testing for hemoglobinopathy, phenylketonuria, and galactosemia.
Enabling Responsible Public Genomics
In the few short months since its launch, we’ve found the Genomics Law Report to be a flexible forum for discussing the legal implications of current developments in the fields of genomics and personalized medicine. Often what reaches the pages of the GLR, however, represents only the highlights from more detailed research and analysis that we undertake in order to thoroughly understand these issues and accurately advise our clients.
We have collected some of that more detailed research and analysis in a law review article, “Enabling Responsible Public Genomics,” to be published next spring in the journal Health Matrix: Journal of Law-Medicine. Here’s the abstract for the article:
The “Wrongful Life” Debate
As briefly mentioned in a prior post and discussed in a Connecticut opinion released last Friday, courts continue struggling to apply standard negligence principles in the context of genetic science, especially in the area of “wrongful life.” In a typical wrongful life case, a physician or geneticist fails to diagnose a severe genetic problem in a fetus. The problem is typically so severe that the parents allege that they would have terminated the pregnancy if they had known of the problem. When the child—or a parent acting on the child’s behalf—brings a claim in court alleging that the physician or geneticist was negligent in failing to diagnose the problem, it is referred to as a “wrongful life” claim.
In tort law, damages are generally compensatory in nature—they are awarded with the goal of returning the injured party to the position he or she held before the injury occurred. In a slip and fall case, for example, a successful plaintiff would recover damages calculated to compensate for medical expenses and income lost as a result of the injury. In the context of a wrongful life claim, however, compensatory damages raise logical problems. The basic claim is that the physician or geneticist made a mistake. Had the mistake not been made, the plaintiff asserts, his or her parents would have terminated a pregnancy.
Strict Liability for Sperm?
The ABA Journal notes an interesting case from a federal district court Pennsylvania, Donovan v. Idant Laboratories (pdf). In 1995, Donna Donovan, the plaintiff, was artificially inseminated with sperm provided by Idant Laboratories, the defendant. Ms. Donovan signed a consent form in which Idant represented that “(1) semen stored at Idant is exceptionally safe; (2) Idant has a screening program that far exceeds mandated standards and (3) Idant’s donors go through a rigorous screening process to ensure that they have a good genetic background and history.”
Donovan gave birth to a daughter, Brittany, in January 1996 using sperm from Idant Donor G738. Brittany was diagnosed with developmental difficulties related to her status as a carrier of the Fragile X gene (FMR1). Testing revealed that Donor G378, not Donna Donovan, carried the Fragile X gene. Donna Donovan sued Idant under a multitude of theories,* both as Brittany’s guardian and on her own.
“Three Generations of Imbeciles Are Enough”
So wrote Justice Oliver Wendell Holmes, Jr. in Buck v. Bell, a 1927 Supreme court case upholding a Virginia law that authorized the state to surgically sterilize certain “mental defectives” without their consent. The fascinating and disturbing history of the case is covered in a recent USA Today article.
Carrie Buck was a patient in the Virginia State Colony for Epileptics and Feeble-minded. Upon a finding that she was “the probable potential parent of socially inadequate offspring, likewise afflicted, that she may be sexually sterilized without detriment to her general health, and that her welfare and that of society will be promoted by her sterilization,” the Court upheld her involuntary tubal ligation. The Court infamously justified its decision as follows:
We have seen more than once that the public welfare may call upon the best citizens for their lives. It would be strange if it could not call upon those who already sap the strength of the State for these lesser sacrifices, often not felt to be such by those concerned, in order to prevent our being swamped with incompetence. It is better for all the world if, instead of waiting to execute degenerate offspring for crime or to let them starve for their imbecility, society can prevent those who are manifestly unfit from continuing their kind. . . . Three generations of imbeciles are enough.
