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.

According to the complaint (pdf) filed in federal court in March 2009 by the Texas Civil Rights Project, the state began to retain the samples for research use in 2002. The five plaintiffs in the lawsuit were parents of children born in Texas, including one woman who was pregnant when the suit was filed. The defendants in the suit were the DSHS and its commissioner, along with Texas A&M University and several university administrators.

In response to the suit, the Texas legislature quickly enacted a law governing the collection of newborn blood samples. The new law, which went into effect in May 2009, provides that the DSHS “may retain for use by the department or laboratory genetic material used to conduct the newborn screening tests.” Parents are given the opportunity to opt out—they can ensure that the samples taken from their child are destroyed by filling out a “Destruction Directive” form (pdf). The new law also provides for de-identification of samples provided to researchers and oversight by an institutional review board.

The defendants claimed that these changes to Texas law made the suit moot—that the case no longer presented a valid legal dispute. In its order (pdf), the court rejected this argument because the new law did not address the blood spots already collected by the DSHS, including those allegedly collected from the plaintiffs’ children.

Having rejected the argument that the changes in the law meant that the suit should be dismissed, the court turned to the interesting question of whether the parents had the right to sue. To sue in federal court, a plaintiff must show “standing”—that he or she is the right person to argue the dispute before the court. Courts analyzing this issue focus on the question of injury—has the defendant caused an injury to the plaintiff that the court has the power to remedy? The question of injury often comes up in public interest cases, and especially in civil rights and environmental litigation. Here, the state claimed that the parents did not meet the injury requirement because the injury they claimed was “only conjectural and hypothetical,” relating only to the “potential for misuse of the blood specimens or ‘medical and genetic’ information contained in them.”

If the court had accepted this argument, it could have set a precedent¹ that would limit future litigation—it would be very difficult for a plaintiff in this sort of case to conclusively show that he or she was directly injured by a misused sample. The court rejected this argument, however, stating that there is “reasonable fear of the potential for misuse because of the continued storage of the samples.” If other courts adopt this standard, a plaintiff suing a laboratory or researcher would not necessarily have to show that his own sample was misused, only that his sample was part of the group of samples subject to misuse. With newborn blood spots—where state policy often requires sample collection from all infants born in the state—this requirement will be easy to meet.

Next, the court addressed the Fourth Amendment of the U.S. Constitution, the first of two federal constitutional theories argued by the plaintiffs. In general terms, the Fourth Amendment protects against “unreasonable searches and seizures” by the government. In their response to the defendant’s motion to dismiss (pdf), the plaintiffs argued that they did not “object to the state’s mandated newborn screening program so long as safeguards are in place to destroy an infant’s samples within a reasonable period of time.” What they objected to, they said, was “the secret seizure of the initial [newborn blood spot] collection as a continuing deprivation of rights” because the state did not have “consent to draw infants’ blood for indefinite storage and undisclosed research, and did so deceptively.”² Although the court did not fully resolve this issue, it did refuse to grant the defendants’ motion to dismiss the lawsuit, a decision that likely precipitated the settlement.

Plaintiffs’ second constitutional argument was based on their right to privacy and liberty under the Fourteenth Amendment. The court found that the plaintiffs stated a claim under the Fourteenth Amendment, assuming that the facts they claimed were true. Specifically, the court noted that the plaintiffs claimed that the blood spots “contain deeply private medical and genetic information, and were expropriated without knowledge or consent,” a claim that the court viewed as involving “bodily integrity.”³ The court also referred to plaintiffs’ claims that the protocols used by the Texas researchers were not consistent with federal protections for human research subjects under the Common Rule, including its requirements for informed consent. Like the Fourth Amendment decision, the court’s recognition that samples of genetic material involves privacy and liberty interests protected by the Fourteenth Amendment could be significant in future cases, possibly providing a form of constitutional protection in situations where the Common Rule may not apply.

Finally, the case is interesting for what it reveals about the interests at stake in civil rights litigation over genetic issues. Here, the plaintiffs and their civil rights lawyer sought to vindicate privacy interests related to their genetic information. They viewed the retention of the samples as government overreaching, as indicated by references to “Big Brother” and “the specter of a DNA data bank” in the Texas Civil Rights Project’s press release announcing the suit. By contrast, the state’s primary interest was continuing its work of screening newborn infants for treatable conditions. As the DSHS stated in its press release announcing the settlement, “settling this lawsuit is in the best interest of this program’s core mission to screen all newborn babies in Texas for life-threatening disorders.” Much to the regret of many researchers, neither party in the case had the primary goal of protecting the millions of samples scheduled for destruction for use in ongoing and future research.⁴

In July 2009, the American College of Medical Genetics released its Position Statement on Importance of Residual Newborn Screening Dried Blood Spots (pdf). In the statement, the ACMG describes opponents of research using retained newborn blood spots as “a very small but very vocal minority” with “arguments based on unsubstantiated and highly exaggerated privacy concerns.” As noted above, federal courts require parties to litigation to demonstrate an “injury”—a real stake in the outcome of a case. In future cases involving newborn blood spots, it will be interesting to see whether individual researchers or groups like the ACMG become more directly involved in such litigation. The result in this case—the destruction of millions of samples pursuant to a settlement agreement between two parties, neither of which was primarily interested in research goals—could well help support such involvement.

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¹Because this case was before a federal district court, it would not bind other federal courts in the same way that a decision in the U.S. Supreme Court or the Circuit Courts can. Nevertheless, district court decisions can be highly influential on other courts, especially when they deal with relatively unexplored legal issues, as this one did.

²The state also argued that all samples were de-identified of any connection to the donor before being used for research purposes. Although this point could impact the legal analysis, including requiring a court to opine on the effectiveness of de-identification as a technique for ensuring privacy, the proceedings never got far enough for it to be relevant.

³The right to bodily integrity, grounded in the Fourteenth Amendment, was a key part of the holding in the 1942 Supreme Court decision in Skinner v. Oklahoma. In Skinner, the Supreme Court held unconstitutional an Oklahoma law that permitted the involuntary sterilization of certain “habitual criminals.” (In the process, it also overturned the result in the infamous case of Buck v. Bell, which we previously discussed on the GLR.) In rejecting the Oklahoma law, the Court held that the power to sterilize can have “subtle, far-reaching and devastating effects,” especially in “evil or reckless hands,” where it could cause “races or types which are inimical to the dominant group to wither and disappear.” Accordingly, the court noted, a person sterilized by the state is a person “forever deprived of a basic liberty.” With this language, Skinner was the first step in the line of cases that eventually led to Roe v. Wade.

⁴Press reports do indicate, however, that the 10,000 to 12,000 bloodspots already released to some 35 different research projects can continue to be used under the terms of the settlement. The court’s docket does not contain a copy of the settlement agreement.

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:

As scientific understandings of genetics advance, researchers require increasingly rich datasets that combine genomic data from large numbers of individuals with medical and other personal information. Linking individuals’ genetic data and personal information precludes anonymity and produces medically significant information—a result not contemplated by the established legal and ethical conventions governing human genomic research. To pursue the next generation of human genomic research and commerce in a responsible fashion, scientists, lawyers, and regulators must address substantial new issues, including researchers’ duties with respect to clinically significant data, the boundary between genomic research and commerce and the practice of medicine, and the challenges to privacy presented by genomic data.

This Article presents a new model for understanding and addressing these new challenges, at its core a “public genomics” premised on the idea that ethically, legally, and socially responsible genomics research requires openness, not privacy, as its organizing principle. Responsible public genomics combines the data contributed by informed and fully consenting information altruists and the research potential of rich datasets in a genomic commons that is freely and globally available. This Article examines the risks and benefits of this public genomics model in the context of an ambitious genetic research project currently under way—the Personal Genome Project—and (i) demonstrates that large-scale genomic projects are desirable, (ii) evaluates the risks and challenges presented by public genomics research, and (iii) determines that the current legal and regulatory regimes restrict beneficial and responsible scientific inquiry while failing to protect participants. The Article concludes by proposing a modified normative and legal framework that embraces and enables a future of responsible public genomics.

If you’re interested in diving deeper into some of the issues we’ve covered here at the GLR—including the challenges of achieving informed consent in an era of large-scale genomic research and of understanding the messy thicket of law and regulation into which public genomics has emerged—a complete draft of the article (submitted in August and already out of date in some respects) is available through SSRN.

We’ll be updating the article between now and publication, so if you have questions or suggestions please feel free to put them in the comments or to contact us directly.

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.

This raises two distinct issues. First, if the mistake had not occurred, the plaintiff would not exist and could not bring a tort claim in court. Second, and perhaps more troubling, the plaintiff in a wrongful life case necessarily claims that she has been injured by a parental decision not to terminate the pregnancy. Put differently, tort law provides remedies to wrongs done to individuals. In a wrongful life case, the “wrong” claimed by the plaintiff is the plaintiff’s own existence, however impaired that existence may be. Accordingly, courts have been quite reluctant to recognize the tort because, as the Illinois Supreme Court put it, they are uncomfortable with the “judgment that an individual life is so wretched that one would have been better off not to exist.”

It is tempting to try to analyze this more subtly and say, on behalf of the plaintiff, that it is not a question of existence versus nonexistence, but rather the difference between a “normal” life and the life the plaintiff will lead, and that the plaintiff should be compensated for the difference. After all, that is similar to what happens in a personal injury case where a plaintiff seeks compensation for the loss of a particular quality of life. The problem with this argument is that in the wrongful life case the plaintiff is not seeking compensation for this “difference.” It is unavoidable that the plaintiff is arguing he or she should not have been born and is seeking compensation for the difference between nonexistence and existence.

The problem with refusing to recognize the wrongful life claim, however, is that it leaves severely injured individuals with no way to recover for their injuries. While the parents can sometimes recover damages under a “wrongful birth” theory, some courts hold that the parents can only recover damages for the increased cost of caring for a disabled child for the first eighteen years of life. In individual cases, the statute of limitations may also be an issue for the parents in a wrongful birth action, as it was in Donovan.

The wrongful life issue is still being debated in state courts, with a large majority of courts refusing to recognize the tort. According to the opinion in the Connecticut case, courts in California, New Jersey, and Washington are the only ones to have recognized the tort. Other courts have ameliorated the harsh consequences of refusing to recognize wrongful life by taking steps such as allowing parents to recover for the cost of care of a disabled adult, as the Connecticut court did here. The wrongful life cases are interesting in their own right, and for what they reveal about the way state courts engage in a process of adaptation and dialogue in response to radical scientific advances, including the development of genetic science.

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.

Although the court dismissed Donovan’s personal claims as outdated, it allowed Brittany’s claims to proceed. As a minor, Brittany’s claims would not expire until two years after her eighteenth birthday. Brittany had two main claims, one based on the theory that Idant was negligent in failing to properly screen the sperm, and the second based on the theory that she was injured by a defective “product,” Donor G378’s sperm.

Brittany claimed that Idant was negligent in failing to adequately screen sperm from Donor G378. Had Idant tested Donor G378’s sperm, however, Donovan would not have been given access to this particular sperm, and Brittany would never have been born. Following New York law, the court viewed this paradoxical result as fatal to Brittany’s claim. The court noted that “no cause of action may be maintained on behalf of an infant plaintiff for ‘wrongful life,’ i.e., that he or she would never have been born but for the negligence of the defendant.”

More significantly, the court allowed Brittany to proceed on the theory that her injuries resulted from a defect in Donor G738’s sperm. Strict product liability is generally based on the idea that manufacturers are best positioned to make their products safer. Instead of having to prove that the manufacturer was negligent, a consumer bringing a strict product liability claim just has to show that he or she was injured by a defect in the product.

Does treating the claim as one for strict product liability really resolve the logical paradox underlying New York’s refusal to recognize wrongful birth claims? Sperm (or eggs) may be unique as “products” with a central role in conception, but I fail to see a clear distinction between a negligence claim for wrongful birth and a strict product liability claim for defective sperm brought by the product of that sperm. In either case, the logical flaw persists — the plaintiff would not exist but for the defect/negligence.

The ultimate resolution to the issues raised by this case may be for states to pass laws placing sperm beyond the reach of product liability claims. Many states already apply such shield laws to blood, and some have extended their shield laws to cover organs and other human tissues. Indeed, this question played a major role in the outcome of this case. As the court noted, Brittany would not have been able to bring her claim under Pennsylvania law, which shields human tissue. Because New York’s equivalent statute shields only blood and blood derivatives, however, the court allowed Brittany’s claims to proceed.

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*The full list of claims includes negligence, breach of contract, third-party beneficiary breach of contract, breach of the express warranty of merchantability, breach of implied warranty of merchantability, third-party beneficiary breach of express and implied warranties of merchantability, negligent misrepresentation, strict products liability and negligent infliction of emotional distress.

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.

State laws permitting sterilization of individuals deemed unfit to reproduce — most commonly institutionalized persons with mental illness, or even conditions such as epilepsy — were common in the first half of the twentieth century. Buck herself did not learn of her sterilization until decades later — she was told at the time that the operation was an appendectomy. According to the USA Today article, more than 65,000 people were sterilized under such laws, which were enacted in more than 30 states.

Today, thanks to the Human Genome Project and its progeny, scientists understand the genetic transmission of mental illness to a degree nearly inconceivable at the time of Buck v. Bell. While the science underlying such efforts may seem as dated today as the pre-Copernican notion that the sun revolves around the earth, the Virginia law upheld in Buck v. Bell was not repealed until 1974.

Some three generations after Justice Holmes penned his infamous statement, Buck v. Bell remain an issue in contemporary debates surrounding law and genetics.

Indeed, Paul Lombardo, a scholar of the case and the focus of the USA Today article, says that he is currently working on a book titled 100 Years of Eugenics: From the Indiana Experiment to the Human Genome Project. The case illustrates two important tensions in the relationship between law and genomics: the capacity of legislators to base social policy on incomplete scientific understandings, and the role of courts in checking or advancing these efforts. The legacy of Buck v. Bell — beyond the thousands of nonconsensual medical procedures it sanctioned—will be in shaping future debate over individual rights where science intersects with the law.

For more:

• Eugenics in California, a report from the California State University in Sacramento on forced sterilizations in the state, which performed over 20,000 such operations.
• Against Their Will, a detailed investigation of North Carolina’s sterilization program from the Winston Salem Journal.