Notice & Comment

Newborn Screening Programs: Protecting People, Not Merely Property

In holding that law enforcement officers could not place listening devices on the outside of a public phone booth without a warrant, the Supreme Court famously proclaimed: “The Fourth Amendment protects people, not places.”  Katz v. United States, 389 U.S. 347, 351 (1967).  That insight provides perspective on two recent decisions regarding the collection and retention of samples taken from newborns under the newborn screening program: Kanuszewski v. Michigan Department of Health and Human Services, 141 F.4th 796 (6th Cir. 2025)(“Kanuszewski v. MDHHS” or “Kanuszewski II”), cert. denied, Kanuszewski v. Shah, Dkt No. 25-830 (March 23, 2026); Lovaglio v. Baston, Dkt. No. 23-21803, 2025 WL 2268133 (D.N.J. Sept. 8, 2025)(Castner, D.J.).  Both cases held the Fourth Amendment inapplicable to the retention of the samples, and their potential distribution to third parties, because plaintiffs could not establish a “possessory interest,” i.e., a “property right” in the sample.  These holding foreclosed judicial inquiry regarding the reasonableness of the states’ policies regarding the retention and secondary use of the samples.  The decision are flawed because, to paraphrase Katz, the Fourth Amendment protects people, not merely property.

I have recently uploaded a paper on SSRN extensively discussing the flaws in the two cases, and more generally discussing the protection of privacy interests in dried blood spots retained by newborn screening programs.  The paper is entitled Newborn Screening Programs & the Fourth Amendment and is accessible here.  Here’s the abstract of the paper:

State newborn screening programs draw blood from newborns to detect dangerous heritable diseases.  After conducting the screening, these programs typically retain residual dried blood spots for years and provide them to third parties in conjunction with medical and public health research or law enforcement activities.  Frequently this occurs without parental consent or knowledge.  Such practices have given rise to increasingly significant controversy over the past 30 years.

Despite the practices’ obvious privacy and parental autonomy implications, two courts recently rejected Fourth Amendment challenges directed at state programs’ stewardship of residual dried blood spots.  Grounded on the U.S. Supreme Court’s standard formulation of Fourth Amendment unconstitutional seizure claims’  essential elements, both courts concluded that the parents, on behalf of themselves and their children, lacked the necessary “possessory interest” in residual dried blood spots to invoke the Constitution’s constraints upon unreasonable seizures.

This article argues that no “possessory” or “property” interest should be needed to invoke the Fourth Amendment’s constraints upon seizures, a reasonable expectation of privacy should be sufficient.  The article explores the implications of such a change in perspective on the constitutional debates surrounding newborn screening program practices, including those surrounding consent, the scope of the administrative search/special needs doctrine, and state parens patriae authority. 

The article then focuses more broadly upon potential extra-judicial privacy protections.  Drawing on the scholarly literature regarding underenforced constitutional norms, the article notes that state legislatures and program policy makers can adopt greater privacy protections than those established as a baseline in constitutional litigation, and considers the potential efficacy of the “political protections” of privacy in this area. It turns out that stakeholders have incentives to advocate for robust privacy protections.  The article  considers the development of at least five sets of recommendations designed to establish robust privacy protections.  In the end, however, constitutional litigation will remain critical to overcoming policymaker inertia, making the courts’ recent refusal to engage in constitutional review of newborn screening program consent and privacy practices problematic.

Below I present a longer summary of the paper.  The citations in this post are sparse but are available in the paper.

Newborn Screening Programs 

State newborn screening programs began in the 1960s to detect phenylketonuria (“PKU”), a rare, inherited disorder that, absent treatment, could lead to mental retardation.  The screening was performed without parental consent. States widely adopted such programs, which were ultimately adopted by all states and U.S. territories.  Over time the number of screened-for diseases has increased. However, the program remains a decentralized largely state-run program. Consequently, states and territories have have widely divergent policies regarding many aspects of their programs. 

While much of the sample collected is used for the initial screening, states maintain residual dried blood spots for varying periods of time.  State policies regarding retention and use of such dried blood spots and associated data are quite varied. Similarly, the information provided to parents about the testing, the requirements for parental consent, and the legitimate bases for refusal to consent are far from uniform.

The federal government assumed more of a role in newborn screening with Congress’ enactment of title 26 of the Children’s Health Act of 2000, Pub. L. 106-310, 114 Stat. 1164, §2601.  Congress established a program to assist states in improving and expanding their newborn screening programs.  Congress thus took its first steps in (1) providing financial assistance to state and territorial programs and (2) promulgating standards that might lead to more uniformity in some aspects of the states and territories’ programs.  Among other things, the legislation directed the Secretary of Health & Human Services to establish the Advisory Committee on Heritable Disorders in Newborns and Children (“ACHDNC”).  The Children’s Health Act of 2008 expanded the ACHDNC’s responsibilities, particularly in the areas of (1) the diseases that should be screened, (2) technical standards regarding collection and prompt testing of samples, and (3) parental notification of the screening results.  Newborn Screening Programs & the Fourth Amendment, supra, at 3-4.

Congress reauthorized the Children’s Health Act in 2014.   Congress has since failed to reauthorize the Act, despite passage of reauthorization bills by the House of Representatives in both the 115th and 116th Congress.[1] In part, Senator Rand Paul has blocked Senate action, due to his concerns about the lack of adequate parental consent to newborn testing and secondary uses of the dried bloodspots.  Newborn Screening Programs & the Fourth Amendment, supra, at 3-4.   

Kanuszewski v. MDHSS II and Lovaglio v. Baston

Kanuszewski II

The Kanuszewski litigation, involving  Michigan’s newborn screening program, has lasted for over seven years, producing several District Court opinions and at least two Sixth Circuit opinions. 

In February 2023, the District Court held a five-day trial devoted to resolving the factual issues surrounding plaintiffs’ Fourth Amendment claims. In its ensuing decision, the Court analyzed all aspects of the Michigan’s program, including retention of blood spots and associated data and the provision of retained blood spots and data to third parties for secondary uses, in terms of the Fourth Amendment doctrines governing searches.  The District Court did not separately analyze any aspect of the program as a violation of the Fourth Amendment’s prohibition against unreasonable seizures

The Court concluded that the Fourth Amendment constrained the newborn screening programs retention and secondary use of dried blood spots. It noted that the blood spots contain highly personal genetic information, potentially revealing details about a person’s health, ancestry, vaccinations, and future health risks.  Thus, retention of the samples, even if justifiable, raised legitimate questions about the duration of retention and the processes in place for potential future use of these samples. (Disturbingly, as of July 2023, the MIchigan BioTrust has approved every disposition of blood spots over the prior 11 years, while lacking any “known record of the number of samples that have actually been submitted to third-party researchers” with their approval. Kanuszewski v. Michigan Dept. Health & Human Servs, 684 F.Supp.3d 637, 651 (E.D. Mich. 2023)).

The Court found that the newborn screening program did not fit withing the administrative-search exception to the Fourth Amendment’s warrant requirement, finding the program’s purpose insufficiently distinguishable from the government’s general interest in crime control. The Court observed that the liberties protected by the Fourth Amendment should buckle under the weight of communal convenience and “utilitarian calculations,” however laudable the outcomes produced by a governmental program.      

In contrast to the District Court, the Sixth Circuit panel distinguished between searches and seizures, applying the separate Fourth Amendment doctrines governing each.  It ultimately found that much of the challenged conduct constituted neither a search nor a seizure, making it unnecessary to engage in a further analysis of either the search or seizure caselaw.

State authorities’ retention of dried blood spots did not constitute a “search” because the mere act of retention did not amount to “an attempt to find something or to obtain information.”    State authorities’ transfer of dried blood spots to private third parties for medical and public health research also were not searches because the transfer of the data reveals no information to the government (even though it would enable the transferee to uncover information about the newborn and its parents).    

The panel then considered whether Michigan’s action violated the Fourth Amendment constraints on “seizures.”  Relying on Supreme Court caselaw, the panel explained that plaintiffs could prevail on such a challenge only if plaintiffs proved that (1) they had a possessory interest in the property, (2) the government meaningfully interfered with that possessory interest, and (3) that interference was unreasonable.  The panel concluded that plaintiffs’ claims foundered on the first element; they had failed to establish any “possessory interest in the blood spots and data.” 

The Court explained that “possessory interests” are created and defined by state law.  The panel noted that at “no point in the litigation had plaintiffs identified any basis for finding such a possessory interest.”  Accordingly, the panel “reverse[d] the district court’s judgment in plaintiffs’ favor as to the Fourth Amendment seizure claims.” Perhaps weary of the litigation, the panel did not suggest that plaintiffs be given an opportunity to replead to set forth any claims of the required possessory interest. (However, one cannot help but think that this is bit of a judicial “surprise switcheroo.” Env’t Integrity Project v. EPA, 425 F.3d 992, 996 (D.C. Cir. 2005)).

Plaintiffs have filed a petition for certiorari petition in the U.S. Supreme Court, Kanuszewski v. Shah, Dkt. No.  25-830 (January 9, 2026). Plaintiffs identified the Fourth Amendment rulings on the data Michigan retains associated with newborn screening as one of the issues on which it seeks certiorari.  Petition for Certiorari, Kanuszewski v. Shah, Dkt. No. 25-820 at i, 22-28. But their primary argument for certiorari is that, as to the dried blood spots that Michigan typically retains, the Sixth Circuit should not have issued an opinion at all.  Id. at 10-21. Plaintiffs argue that the District Court’s entry of a permanent injunction requiring defendants to return the samples to plaintiffs, and defendant’s compliance with the order, made the case moot. By complying with the order, rather than seeking to stay it, defendants had deprived the Sixth Circuit of jurisdiction to consider the District Court’s resolution of any issues related to Michigan’s practice of retaining dried blood spots was consistent with the Fourth Amendment.[2]  Puzzlingly, defendants waived the right to reply to the certiorari petition.  Perhaps defendants have little interest in contesting plaintiffs’ jurisdiction argument, and agree that Fourth Amendment issues the case raises are certworthy. In any event, the case was distributed to the Justices for the March 20, 2026 conference. Hours before this post was filed, the Supreme Court denied certiorari in Kanuszewski.

Lovaglio v. Baston

Lovaglio v. Baston involves New Jersey’s policies regarding retention an use of dried blood spots.  By statute, newborn screening is mandatory unless the baby’s parents or guardian objects to testing on religious grounds.  N.J. Stat.§ 26:2-111. 

Section 26:2-111 provides that “[i]nformation on newborn infants compiled under the program shall be used by the department and agencies designated by the commissioner for the purposes of carrying out this act.”  Otherwise “the information shall be confidential and not divulged or made public so as to disclose the identity of any person to which it relates, except as provided by law.”  Section 26:2-111 is silent on the retention of the dried blood spots themselves, presumably leaving that decision to the discretion of the agency charged with implementing the statute, namely New Jersey Department of Health (“NJDOH”).

NJDOH’s practice, when the litigation began, was to store the residual dried blood spots for 23 years.  It is not clear whether parents were informed that residual dried spots would be retained or would be used for any secondary purpose. The blood spots were occasionally used for law enforcement purposes.  Plaintiffs alleged that the State provides dried bloodspots to third parties, such as researchers, companies, and other government agencies.  The extent of that practice was unclear at the time plaintiffs filed suit.

The State engaged in lengthy negotiations to resolve the suit.  Though their efforts failed, NJDOH and the Attorney General altered their newborn screening policies nevertheless.    Now the State retains unused dried blood spots for two years, if the newborn’s blood tests negative, and ten years if it tests positive.  NJDOH provides parents with a card explaining that NJDOH uses newborn blood spots for “only” three purposes: (1) newborn screening, (2) routine quality assurance and quality control for DOH’s lab, and (3) developing new tests for disorders.  Any blood used for the second or third purposes will be de-identified.   The card also asserts that NJDOH will not release residual dried blood spots “in identified form to non-law enforcement third parties without [parental] consent.”

Simultaneously, the New Jersey Attorney General issued a directive to all state prosecutors that any documentary records and/or physical bloodspots maintained by the Newborn Screening Program may be obtained only by: (1) a subpoena issued by a municipal court judge, (2) a search warrant based on probable cause, or (3) an administrative subpoena (or appropriate court process) issued in a missing persons or unidentified-body case.  The Directive is not enforceable by private citizens.

The Lovagolio plaintiffs raised Fifth Amendment substantive due process arguments and Fourth Amendment arguments with respect to the retention of newborns’ blood beyond its use in the initial screening for birth defects.  Defendants asserted that plaintiffs lacked a possessory interest in the residual dried blood spots and, therefore, could not establish a seizure under the Fourth Amendment. Alternatively, defendants argued that any seizure falls within the Fourth Amendment’s “special needs” exception. 

Following the Sixth Circuit’s lead in Kanuszewski II, the District Judge held that a seizure would exist only if plaintiffs could assert such a possessory interest in the blood extracted to perform the newborn screening.  The Court looked to federal and state law to determine whether such a property interest had been recognized.[3] 

The plaintiffs have now filed a second amended complaint.  However, plaintiffs do not supply the missing component of their seizure claims, namely the source of positive law which provides them with a possessory interest in the blood cards created with the blood spots of their newborns.  (Indeed, the term “possessory” appears only once in the second amended complaint.)

Analyzing The Fourth Amendment’s Prohibition on Unreasonable Seizures

Lawyers, jurists, and scholars broadly versed in administrative law know that the in resolving Fifth and Foureeteenth Amendment procedural due process challenges, the Supreme Court has refused to give the term “property” independent content beyond positive law.  Procedural due process protections attach only to “property” interests created and defined by some form of positive law independent of the Due Process Clause itself. Such positive law can include state constitutional provisions, federal or state statutes or regulations, or contracts, inter alia.  Board of Regents v. Roth, 408 U.S. 564, 577 (1972).[4] (Notably, the Kanuszewski II and Lovaglio v. Baston‘s courts’ focus on the need to establish a “possessory” interest” appears to ignore the property law adage that property is a “bundle of sticks” that may be distributed among several people, and that the right to possession is merely one stick in the bundle. See, e.g., JOSEPH WILLIAM SINGER, INTRODUCTION TO PROPERTY §1.1.2 (2d ed. 2005); A. M. Honoré, Ownership, in OXFORD ESSAYS ON JURISPRUDENCE (A.G. Guest ed. 1961).)

Contrastingly, the concept of “privacy” for purposes of the Fourth Amendment, is not solely a creature of positive law.  Rather the privacy interests encompassed by the Fourth Amendment, at least for purposes of the Amendment’s limitation on searches, encompasses reasonable expectations of “privacy.”[5]  Thus, one need not identify some form of positive law to find a reasonable expectation of privacy, protected by the Fourth Amendment warrant and “probable cause” requirements.[6]

The privacy interest in medical records, and particularly genetic records, is clear.  Many states, like New Jersey and Michigan have statutes that protect the confidentiality of genetic information.[7]

Leaving aside the requirement of “state action,” in many cases third parties cannot engage in secondary use of dried blood spots without conducting a Fourth Amendment search.  But the requirement for “state action” presents an impediment in many cases.  Transfer of blood spots and data to law enforcement authorities for purposes of conducting a search could be constrained because the law enforcement search would constitute “state action” subject to the Fourth Amendment constraint.  But, as Kanuszewski II noted, provision of dried blood spots to a private medical and public health researchers could result in testing that may not constitute “state action.”  Thus, such a program of transfers for medical and public health research, the bulk of the transfers that take place, might escape Fourth Amendment review altogether.  (Granted, some medical and public health researchers may be affiliated with institutions that are governmental entities, such as state universities.)

Ironically, such issues have been discussed in the traditional property context, with Moore v. Regents of the University of California, 51 Cal.3d 12 (1990), being a staple of Property Law casebooks.  John Moore underwent treatment for hairy-cell leukemia at the Medical Center of the University of California at Los Angeles (UCLA Medical Center).  Doctors recommended a splenectomy to slow the disease’s progression. They performed the splenectomy, but kept part of the extracted organ to develop a cell-line from the tissue. 

Moore sued for conversion, arguing that his spleen, as well as the blood sample later taken in connection with developing the cell line, were his “property.”  In refusing to find a conversion cause of action, the California Supreme Court said: “one may earnestly wish to protect privacy and dignity without accepting the extremely problematic conclusion that interference with those interests amounts to a conversion of personal property.” “Nor is it necessary to force the round pegs of ‘privacy’ and ‘dignity’ into the square hole of ‘property’” to protect patients.  Instead, the Court found the doctrine of informed consent sufficient to protect patient’s legitimate interests in their privacy and autonomy.  Newborn Screening Programs & the Fourth Amendment, supra, at 17-18.[8]

Extra-Judicial Efforts to Address Privacy Concerns

Policymakers and legislators can and often do provide far greater privacy protections than those crafted by courts in constitutional litigation.  Such non-judicial government actors must provide the basic level of protection guaranteed by the federal constitution (and similar privacy-protective provisions of state constitutions), but can offer greater privacy protections.[9]    

The critical nature of privacy has long been recognized in the medical setting by the physician-patient privilege protecting communications between doctors and patients.   More recently, the importance of medical privacy has been recognized by the U.S. Department of Health & Human Services HIPAA regulations,  which was prompted by congressional legislation.   In the context of newborn screening in particular, physicians and researchers have long been quite sensitive to the need for public acceptance of newborn screening and the practices of protecting blood spots and data associated with the program.  Newborn Screening Programs & the Fourth Amendment, supra, at 28.  Even though there appear to be only four reported cases regarding constitutional challenges to newborn screening programs, Beleno v. Lakey, 306 F.Supp.3d 930, 944-45 (2009), Bearder v. State, 806 N.W.2d 766 (Minn. 2011), Kanuszewski, and Lovaglio v. Baston, the prospect of constitutional litigation has had an outsized impact on the newborn screening community, prompting examination of standards for informed consent as well as for retention and secondary use of dried blood spots (particularly for law enforcement purposes).

In 1995, the Newborn Screening Committee of the Council of Regional Networks for Genetic Services (CORN) issued a report on the retention and secondary use of dried blood spots.  Bradford L. Therrell, et al., Guidelines for the Retention, Storage, and Use of Residual Dried Blood Spot Samples after Newborn Screening Analysis: Statement of the Council of Regional Networks for Genetic Services, 57 BIOCHEMICAL AND MOLECULAR MEDICINE 116 (1996).  The Committee found that although most programs destroyed residual DBS samples within a year after completing the newborn screening,[10] some retained them for longer and made them available to researchers an others on an ad hoc basis.  The Committee’s report and recommendations were the newborn screening community’s first published guidance regarding the retention, storage, and use of residual dried blood spots.  Newborn Screening Programs & the Fourth Amendment, supra, at 29.

Little more than a decade later, the ACHDNC began extensive consideration of the issues surrounding retention and use of dried blood spots.  ACHDNC reviewed the issues facing state programs to lay the foundation for formulating national guidance.  Bradford L. Therrell, Jr., Considerations and Recommendations for National Guidance Regarding the Retention and Use of Residual Dried Spot Specimens After Newborn Screening, 13 GENETICS 621, 623 (2011).  It noted that “programs must protect privacy and confidentiality and ensure the public’s trust” while “recognizing the potential research value of residual [newborn blood spot] specimens for advancing science and clinical care.”   The eight recommendations focused on urging programs to adopt and maintain policies regarding access to, use, and disposition of dried blot spots.  ACHDNC also suggested that the HHS Secretary “facilitate national dialog among federal and state stakeholders” regarding policies governing retention and use of residual bloodspots, “including model consent and dissent process[es].” Newborn Screening Programs & the Fourth Amendment, supra, at 29-30. (It is not clear the the HHS Secretary ever sought to initiate such a national dialogue.)

Two years later a group of five medico-legal scholars, led by Jeffrey R. Botkin, published a set of guidelines after conducting extensive consultations with a wide range of stakeholders.   Jeffrey R. Botkin, et al., Retention and Research Use of Residual Newborn Screening Bloodspots, 131 PEDIATRICS 120 (2013).  They too recommended that states develop policies and procedures regarding retention and research use of dried blood spots, including specifying how long specimens will be retained.  The group also “strongly encouraged” states to make retained specimens available to “qualified scientific investigators.”   The group recommended that only deidentified specimens should be provided for research purposes, “unless specific approval is obtained from an institutional review board for use of identifiable specimens.” Newborn Screening Programs & the Fourth Amendment, supra, at 30-31.

Botkin and his colleagues concluded that either an opt-in or opt-out approach for obtaining parental consent was “ethically acceptable.”   But they emphasized that parents should be informed of critical information “in a meaningful way that permits an informed decision,” and that such information should be provided “in both the prenatal and postnatal periods.”  Id. 

The group discouraged permitting “ready access” to dried blood spots by the justice system.   Moreover, even though not required by federal regulation, the group recommended that all research seeking access to dried blood spots be reviewed and monitored by an institutional review board.  Id. 

In 2025, both NORD and National Academies of Sciences, Engineering, and Medicine issued recommendations regarding the retention and use of dried blood spots.  National Organization for Rare Disorders, Preserving Public Trust in the U.S. Newborn Screening Systems: Policy Principles and Recommendations on Retention and Secondary Use of Residual Dried Blood Spots (Feb. 2025); National Academies of Sciences, Engineering, and Medicine, Newborn Screening in the United States: A Vision for Sustaining and Advancing Excellence (The National Academies Press 2025).

NORD prefaced its updated recommendations by noting that “recent legal challenges and law enforcement actions have drawn attention, sparked controversy, and raised questions about residual DBS retention and secondary use.”   The group asserted that “newborn screening programs and policymakers across the country [were] work[ing] to address [such] concerns.”  It asserted that “the newborn screening system must take proactive steps to build trust through policy, transparency, and effective communication.”  Newborn Screening Programs & the Fourth Amendment, supra, at 31. 

In developing its recommendations, NORD had engaged in significant consultations with thirteen “patient advocacy organizations” that were NORD members.  It noted those organizations’ concerns that “a lack of transparency about residual DBS retention and secondary use” and law enforcement access to such samples would “erode public trust in newborn screening programs and contribute to screening hesitancy.”  Id. 

The report set forth four “policy principles,” followed by four sometimes multipart recommendations.   In terms of the policy principles, NORD states, first, that newborn screening programs must act as “good stewards of residual DBS and newborn screening data.”   Such stewardship entailed (1) maintaining “robust privacy and confidentiality protections,” (2) using material transfer agreements with recipients of dried blood spots specifying the purposes for which the dried blood spots can be used and prohibiting reidentification of the samples, and (3)“never permitting law enforcement access” to residual dried blood spots.  Id. 

Second, newborn screening programs should “preserve” the parents and the newborn’s “autonomy and choice in decision-making about residual dried blood spot retention and secondary use.”  Third, “secondary use of residual DBS should advance public health and the optimal functioning of newborn screening programs.”   In other words, the interests in secondary research should be subordinated to avoid “jeopardize[ing]” either the universality of newborn screening” or “the ability to conduct critical program activities.” Fourth, dried blood spot retention and secondary use decisions and policies “should be transparent and accessible to the public.”  Id. at 32. 

For its part, the National Academies for Science, Engineering, and Medicine asserted that building public trust required states to heed “longstanding calls for more systematic information for parents and caregivers about newborn screening during the perinatal period.” Id. at 33. 

The Academy noted that some states’ practices of permitting law enforcement access to dried blood spots for criminal or civil liability raised legal concerns and could erode public trust in newborn screening programs.  The Academy recommended that “[s]tate legislatures . . . set law and policy for the retention, sharing, and use of newborn dried blood spots and any derived data with at least four goals in mind.”   Id.

First, such laws and policies must “[p]rotect the retention of . . . dried blood spots for at least a limited period [needed to complete the program’s] primary public health screening goals.”   Second, state law must “[s]et transparent practices for the retention, sharing, and use of dried blood spots for [any other] purposes (including research).”   Third, state law should grant “parents the option to request the destruction of their child’s specimen after the limited time period of retention for primary public health screening goals,” and accord the same option to the newborn upon attaining the age of majority.   Fourth, state law must “[p]rohibit the sharing or use of dried blood spots and associated data to conduct [any] criminal, civil, or administrative investigations and/or impose criminal, civil, or administrative liability upon the blood spot contributor, i.e., the newborn or blood relatives. Id. at 33-34.

The themes of all of these efforts have been a concern about (1) using lack of dissent as a basis for parental consent to the initial screening and to the retention and secondary use of dried blood spots, (2) the quality of the information provided parents of newborns (including encouraging provision of such information in the pre-natal as well as post-natal periods), (3) concerns about secondary uses jeopardizing public support for the newborn screening program, and (4) concern about law enforcement or other forensic use of retained dried blood spots.  It is clear that potential constitutional challenges, although quite rarely filed, have served to encourage the newborn screening community to focus on these issues.


[1] Newborn Screening Saves Lives Reauthorization Act of 2019, H.R. 2507, 116th Cong.;  Newborn Screening Saves Lives Reauthorization Act of 2021, H.R. 482, 117th Cong..  A reauthorization Act has been introduced in the current Congress as well.  Newborn Screening Saves Lives Reauthorization Act of 2025, H.R. 4709, 119th Cong, 1st Sess.

[2] Plaintiffs’ view their argument as an application on the Munsingwear rule.  In United States v. Munsingwear, Inc., 340 U. S. 36, 38–39 (1950), the Court stated that when a case becomes moot and thus precluded the loosing party from obtaining appellate review, the loosing party’s request for vacatur of the lower court’s judgment should be entertained, and granted in appropriate circumstances.  The rule is premised on the fact that when a case becomes moot, the losing party is generally deprived of the right to appeal the merits of an adverse decision.  E.g. U. S. Bancorp Mortgage Co. v. Bonner Mall Partnership, 513 U. S. 18, 21–22 (1994). 

It seems odd that a party that complies with a court order while simultaneously appealing the ruling should be considered to have mooted the case, particularly when closely related aspects of the case remain live controversies (and, indeed, supposedly certworty ones).  Moreover, in these circumstances, Munsingwear might suggest that the District Court’s opinion must be vacated. Permitting a trial court opinion to stand while vacating a contrary appellate court ruling would seems to be precisely the scenario Munsingwear vacatur was designed to avoid. Indeed, perhaps the numerous prior opinions issued during the cases seven-year odyssey through the federal courts must be vacated if plaintiffs’ aruments on mootness and Munsingwear vacatur are correct.  In any event, this specific application of the “mootness” and Munsingwear doctrines hardly seems certworthy. 

It is worth noting that just three years ago Justice Jackson critiqued the Supreme Court’s practice of routinely granting Munsingwear vacatur.  Chapman v. Doe, 598 U. S. ____, 143 S.Ct. 857 (2023)(Jackson, J., dissenting). She noted, quoting Bancorp, that” our common-law system assumes that judicial decisions are valuable and should not be cast aside lightly, especially because judicial precedents ‘are not merely the property of private litigants,’ ” but also belong to the public and “ ‘legal community as a whole.’ 143 S.Ct. 858.  Accordingly, in her view, “it is crucial that [the Court] hold the line and limit the availability of Munsingwear vacatur to truly exceptional cases.” Id.

[3] In the paper, I suggest that the Court may even have erred in failing to find the existence of a “property” right supported by positive law.  Newborn Screening Programs & the Fourth Amendment, supra, at 14-15.

[4] “Property interests . . . are not created by the Constitution. Rather, they are created and their dimensions are defined by existing rules or understandings that stem from an independent source such as state law—rules or understandings that secure certain benefits and that support claims of entitlement to those benefits.”  Board of Regents v. Roth, 408 U.S.  at 577.

[5] The Fourth Amendment protections against unreasonable searches and seizures involved the court independently defining reasonable expectations of privacy.  Minnesota v. Carter, 525 U.S. 83, 88 (1998); See, 2 WAYNE R. LAFAVE, ET. AL., CRIMINAL PROCEDURE § 3.2(a) (4th ed.)(accessible on westlaw).  However, as I have noted elsewhere, thus far the Court’s view of the reasonable expectations of privacy is quite anemic and out of step with the actual expectations of privacy among Americans. Bernard W. Bell, Secrets & Lies: News Media and Law Enforcement Use of Deception as an Investigative Tool, 59 U. PITT. L. REV. 749, 793-96 (1999).

[6] In the paper I discuss the possible application of the consent search and the administrative search/special needs exceptions to the probable cause and warrant requirements to the newborn screening programs.  Newborn Screening Programs & the Fourth Amendment, supra, at 18-23.

[7] ROGER HAKIMIAN, ET AL., 50-STATE SURVEY OF LAWS REGULATING THE COLLECTION, STORAGE, AND USE OF HUMAN TISSUE SPECIMENS AND ASSOCIATED DATA FOR RESEARCH (2004)(NIH Publication No. 05-5628); Kayte Spector-Bagdady, et al., Analysis of State Laws on Informed Consent For Clinical Genetic Testing in the Era of Genomic Sequencing, AM. J. MED. GENET. C. SEMIN. MED. GENET. 178(1): 81–88 (March 2018);  see, e.g., MICH. COMP. LAWS ANN. § 333.17520.

[8] In the paper I also briefly discuss the Fifth Amendment right to informational privacy. Newborn Screening Programs & the Fourth Amendment, supra, at 24.

[9] I discuss under-enforced norms theory, a theory that the political branches are more appropriate than the courts to protect constitutional norms at the margins in some circumstances,  see generally, Lawrence Gene Sager, Fair Measure: The Legal Status of Underenforced Constitutional Norms, 91 HARV. L. REV. 1212 (1978), and assess the comparative strengths and weaknesses of the Judiciary and policymakers in addressing privacy issues raised by newborn screening programs.  Newborn Screening Programs & the Fourth Amendment, supra, at 25-28.

[10] The shortness of most states’ retention of dried blood spots was not due to solely altruistic motives; there was “[a] widely disseminated belief” that saved samples could only negatively impact a program’s legal liability by providing evidence” of any negligent failure detect a harmful heritable condition.