Executive Summary
This analysis exposes how Psychemedics Corporation transformed unvalidated science into accepted governmental policy through decades of marketing misrepresentation and regulatory silence. In 2019, the company publicly claimed that its hair-based drug-testing methods were “FDA-cleared” and “forensically proven.” These assertions, repeated in municipal contracts and disciplinary proceedings, were false. No immunoassay device has ever been cleared by the Food and Drug Administration for use on hair matrices under 21 C.F.R. § 862.3870.
Drawing on the Palaguachi and HARMS Citizen Petitions, this piece traces how those misrepresentations infiltrated the New York City Police Department’s employment-screening system, resulting in wrongful terminations and racially disparate impacts. Scientifically, hair testing for cannabinoids cannot distinguish ingestion from environmental exposure and disproportionately affects Black and Brown individuals due to melanin binding. Legally, it fails every standard of admissibility and validity under Frye, Daubert, Rule 7.01 of the New York Rules of Evidence – Opinion of Expert Witness, and UGESP.
At the federal level, Psychemedics’ conduct constitutes off-label promotion and misbranding under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 331–333. At the employment-law level, the NYPD’s reliance on these tests violates Title VII, the Rehabilitation Act, and the ADA, transforming scientific unreliability into civil-rights injury. Under New York State and City law, the practice contravenes Executive Law § 296, Civil Rights Law § 40-c, the New York City Human Rights Law, and the City’s False Claims Act—each designed to prevent discrimination and protect the integrity of public procurement.
The City’s continued use of Psychemedics’ tests, despite explicit judicial and scientific warnings, satisfies the definition of deliberate indifference under Monell v. Department of Social Services, 436 U.S. 658 (1978), reaffirmed in Chislett v. New York City Department of Education (2d Cir. 2025). Beyond statutory breaches, Psychemedics’ behavior constitutes negligence and negligence per se, as defined in Landon v. Kroll Laboratories, Inc., 22 N.Y.3d 1 (2013), for violating duties of care owed to test subjects and municipal clients alike.
Ultimately, the Psychemedics case reveals a failure of scientific governance—where regulatory silence, corporate marketing, and bureaucratic deference allowed pseudoscience to masquerade as evidence. The Palaguachi and HARMS Petitions mark the turning point: the moment when endurance ceased to equal legitimacy, and the law was forced to reclaim its role as the guardian of empirical truth.
I. Introduction
In October 2019, Psychemedics Corporation issued a public statement through BioSpace responding to the Massachusetts Supreme Judicial Court’s decision in Boston Police Department v. Massachusetts Civil Service Commission. The company’s announcement sought to reassure shareholders and clients that its hair-based drug-testing method remained scientifically reliable and legally sound. Its tone was confident—asserting that its technique had been validated by the FBI, endorsed by courts, and cleared by the United States Food and Drug Administration (FDA).
Yet those claims were not scientific truths; they were marketing performances masquerading as regulatory fact.
The episode exemplifies a chronic weakness in the American evidentiary system: the law’s vulnerability to persuasive but unverified science. Forensic history is crowded with once-“accepted” methods—blood-spatter patterning, bite-mark identification, and microscopic hair comparison—that endured not because they were empirically valid, but because they were repeated. Each gained longevity through institutional habit, not scientific legitimacy, until independent review finally exposed them as unreliable. Psychemedics’ 2019 statement sits squarely within that lineage of error: an effort to transform contested methodology into unquestioned authority through repetition and appeal to institutional confidence.
The 2019 BioSpace statement followed decades of controversy surrounding Psychemedics’ use of hair analysis to detect drugs of abuse—a method the company marketed as a “revolutionary” alternative to urine testing. In its promotional materials, Psychemedics portrayed itself as both scientific innovator and forensic authority. But beneath the rhetoric lay a method that has never been cleared by the FDA for use on hair matrices, has never satisfied the Frye, Rule 7.01 of the New York Rules of Evidence – Opinion of Expert Witness, Daubert, or Uniform Guidelines on Employee Selection Procedures (UGESP) standards, and has been repeatedly criticized by independent scientific bodies for its inability to distinguish actual drug ingestion from environmental exposure.
Through repetition in procurement documents, courtroom testimony, and public-relations materials, Psychemedics’ marketing language migrated from commerce to governance. What began as a corporate sales claim evolved—through bureaucratic inertia—into municipal truth. When the City of New York and its police department adopted Psychemedics’ testing as a screening tool for officers and applicants, they did so without independent validation or regulatory authorization, thereby transforming a private vendor’s assertions into official policy.
That decision culminated in a record of evidence now documented in two formal filings before the FDA: the Palaguachi Citizen Petition and the Harmed Americans for Reform in Medical-Device Safety (HARMS) Citizen Petition.
The Palaguachi Citizen Petition—filed second—establishes the human and institutional harm caused by Psychemedics’ unapproved testing within the NYPD, including the termination of Officer Frankie F. Palaguachi based solely on an invalid result. The HARMS Citizen Petition, filed first, provides the scientific and regulatory framework confirming that Psychemedics marketed and sold a medical device for a use the FDA never cleared or supervised. Together, the two petitions form a unified record of misrepresentation and institutional failure—a portrait of how scientific uncertainty becomes governmental orthodoxy when left unchallenged.
This analysis examines how Psychemedics’ 2019 BioSpace statement—and the City of New York’s reliance on its underlying misrepresentations—illustrate the collapse of scientific integrity within administrative law. Drawing on the Palaguachi and HARMS Citizen Petitions, it traces how unvalidated forensic claims gain legal traction, how agencies convert marketing into policy, and how that process violates federal, state, and local standards designed to protect due process and civil rights.
II. The Testing Methods: Hair Analysis and Enzyme-Immunoassay
A. Hair Analysis Using Radioimmunoassay Techniques
The forensic use of hair as a biological matrix dates back to 1858, when Hoppe (first name unconfirmed in available sources) reported detecting arsenic in exhumed human hair to confirm poisoning. For more than a century, hair analysis remained limited to classical toxicology—applied to heavy-metal and poison detection rather than behavioral or drug monitoring. The method’s early use was purely retrospective, designed to confirm exposure long after death, not to infer active or voluntary ingestion. Its scientific context was chemistry, not forensic inference.
The modern era of drug detection did not begin until 1977, when Dr. Werner Baumgartner, working at the Wadsworth VA Laboratory in Los Angeles, developed the first radioimmunoassay of hair (RIAH) to detect opiates. By dissolving keratinized hair into a liquid phase and treating it as though it were urine, Baumgartner sought to demonstrate that hair could serve as a long-term biomarker of drug use. This technique—later expanded by European researchers in the early 1980s to detect cocaine and other controlled substances—marked the beginning of commercial hair testing for drugs of abuse.
Dr. Baumgartner would later become a co-founder of Psychemedics Corporation, the company that commercialized his experimental method and introduced it into employment and law-enforcement screening programs across the United States. From its inception, however, the technique lacked standardized extraction protocols, external-contamination controls, or statistical validation of dose–response relationships. It entered the marketplace decades before the FDA evaluated or approved any immunoassay for use on hair matrices. What began as a laboratory curiosity became a commercial enterprise, built on an evidentiary assumption that had never been scientifically or legally proven.
Unlike urine or blood testing, which measures the active presence of a drug or its metabolite in the body at a specific point in time, hair testing attempts to infer a pattern of use extending months into the past. Because hair is an external tissue constantly exposed to the environment, it is highly susceptible to contamination—from secondhand smoke, surface contact, airborne particles, and cosmetic treatments.
Hair’s keratin structure and melanin content also vary among individuals, producing racially correlated differences in absorption. Darker, coarser hair binds lipophilic compounds such as tetrahydrocannabinol (THC) and cocaine more strongly than lighter or chemically treated hair, generating systematically higher concentrations in Black and Brown populations regardless of actual use.
Independent reviews by the National Research Council (2009) and the President’s Council of Advisors on Science and Technology (2016) each concluded that hair testing lacks validated analytical protocols, reproducibility, and standardized cutoff thresholds capable of distinguishing ingestion from passive exposure. Subsequent peer-reviewed studies—including Moosmann et al. (2015) and Taylor et al. (2017)—confirmed that identical metabolite concentrations can result from mere environmental contact.
Because of these scientific deficiencies, radioimmunoassay hair testing has never achieved general acceptance in forensic toxicology and is inadmissible under Frye, Rule 7.01 of the New York Rules of Evidence – Opinion of Expert Witness, Daubert, and the Uniform Guidelines on Employee Selection Procedures (UGESP). No federal agency—including the Substance Abuse and Mental Health Services Administration—recognizes hair testing for cannabinoids as a validated or approved matrix for workplace drug detection.
B. Enzyme-Immunoassay Testing and Psychemedics’ Misuse
Enzyme-immunoassay (EIA) is a biochemical screening technique employing enzyme-linked antibodies to detect drugs or metabolites in biological specimens. When used properly on blood, saliva, or urine, it serves only as an initial screening tool; federal guidelines require confirmatory testing by gas-chromatography–mass-spectrometry (GC/MS) or liquid-chromatography–mass-spectrometry (LC/MS) to ensure specificity and eliminate false positives.
In May 2012, Psychemedics obtained FDA clearance for its Microplate Enzyme-Immunoassay for Cannabinoids (510(k) K111929), referencing its earlier RIA device (K011426) as predicate. Both clearances fall under 21 C.F.R. § 862.3870, which applies strictly to testing of serum, plasma, saliva, and urine—not hair. Despite this limitation, Psychemedics expanded the method to hair matrices without validation, asserting equivalence that does not exist.
Hair’s keratinized composition alters antibody–antigen interactions, producing cross-reactivity, inconsistent recovery, and elevated false-positive rates. Psychemedics’ cutoff levels for THC metabolites are internally generated, unpublished, and unverified by independent laboratories. By promoting enzyme-immunoassay for hair testing, the company effectively converted a federally cleared medical device to an unapproved use—circumventing FDA safeguards and misleading municipal employers, including the New York City Police Department, into believing the test was “FDA-cleared” and “forensically proven.”
In scientific terms, enzyme-immunoassay applied to hair is not a validated analytical method; in legal terms, it is inadmissible under Frye, Rule 7.01 of the New York Rules of Evidence – Opinion of Expert Witness, Daubert, and UGESP; and in regulatory terms, it constitutes off-label promotion of a medical device in violation of the Federal Food, Drug, and Cosmetic Act.
The NYPD’s reliance on this unapproved methodology in both applicant screening and disciplinary actions represents a profound failure of oversight—one that exposed employees and candidates to arbitrary results unsupported by any legitimate scientific, regulatory, or civil-service standard.
III. Institutional Misconduct: How Unvalidated Science Became Policy
The New York City Police Department’s adoption of Psychemedics Corporation’s hair-based drug testing was not the result of independent scientific review or regulatory authorization. It was an act of administrative convenience, born of a long-standing pattern in which the appearance of scientific certainty substitutes for actual validation. What began as a vendor’s promotional claim—that its method was “FDA-cleared” and “forensically proven”—was absorbed uncritically into departmental policy, transforming private marketing into governmental truth.
Beginning in the mid-1990s, the NYPD incorporated Psychemedics’ radioimmunoassay of hair (RIAH) into its pre-employment and internal screening protocols. By 2012, the department had migrated to the company’s enzyme-immunoassay (EIA) platform, believing it to be a newer, more sophisticated iteration of the same “FDA-approved” science. In reality, neither method had ever been evaluated or cleared for use on hair. The department conducted no validation studies under the Uniform Guidelines on Employee Selection Procedures (UGESP), commissioned no independent toxicological reviews, and never sought clarification from the Food and Drug Administration as to whether hair testing fell within the scope of existing clearances under 21 C.F.R. § 862.3870.
Instead, procurement officers and medical administrators adopted Psychemedics’ own promotional materials verbatim, reproducing corporate language in city contracts, policy manuals, and courtroom testimony. That repetition created the illusion of consensus. Over time, that bureaucratic inertia did more than harden false claims into ‘common knowledge’; it converted private marketing into the architecture of public policy. The pattern mirrored a broader phenomenon in administrative law: regulatory silence transforming into presumed legality.
This silence was not benign. It enabled the NYPD to rely on a testing methodology that disproportionately harmed Black and Brown candidates, violated established evidentiary standards, and failed every metric of job-related validity required under federal civil-rights law. Yet the department continued to represent the method as “scientifically reliable,” citing its longevity rather than its legitimacy. Each renewal of the Psychemedics contract reinforced the false perception that long-term use equated to validation—precisely the fallacy condemned by the National Research Council (2009) and the President’s Council of Advisors on Science and Technology (2016).
The problem was not merely negligence; it was institutionalization. Internal legal advisors, hearing officers, and even administrative law judges deferred to the department’s assumed expertise, treating the test’s persistence as proof of accuracy. In practice, this meant that officers and applicants could be—and were—terminated, disqualified, or disciplined on the basis of evidence that would have been inadmissible under Frye, Rule 7.01 of the New York Rules of Evidence – Opinion of Expert Witness, Daubert, and UGESP.
Over time, this practice evolved into a self-reinforcing policy architecture:
Procurement treated Psychemedics’ language as regulatory fact.
Legal counsel defended the program based on that procurement record.
Disciplinary tribunals relied on counsel’s representations to sustain penalties.
Judicial review then deferred to the tribunal’s “expertise.”
At each level, the same unvalidated premise was recycled and re-ratified, until the fiction became indistinguishable from law.
This is not administrative oversight; it is institutional misconduct. It represents the deliberate perpetuation of unvalidated science for the sake of bureaucratic continuity and political convenience. The NYPD’s reliance on these methods reveals a governance model in which policy is justified not through evidence but through endurance—a model that treats the absence of regulatory intervention as proof of compliance.
By turning scientific silence into administrative policy, the City of New York converted untested technology into a mechanism of exclusion and control. And by defending that practice through appeals to “experience” and “tradition,” it conflated repetition with truth. As history has shown—from discredited blood-spatter analysis to microscopic hair comparison—the law’s deference to “accepted” techniques is often the very reason pseudoscience survives.
IV. Legal Violations and Implications
The misuse of unvalidated drug-testing methods by Psychemedics Corporation and the New York City Police Department implicates multiple tiers of legal authority—federal regulatory law, employment-discrimination statutes, constitutional protections, and local civil-rights enforcement regimes. Each tier reveals a distinct, yet convergent, pattern of violation: a systemic reliance on pseudoscience to make employment determinations, sustained by administrative silence and shielded by institutional inertia.
A. Federal Regulatory Violations
At the federal level, Psychemedics’ conduct squarely violates the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301 et seq. The company marketed and distributed immunoassay devices for hair testing—an intended use never cleared under 21 C.F.R. § 862.3870 (which applies to serum, plasma, saliva, and urine). By holding out those devices as “FDA-cleared” for hair and by omitting any conspicuous limitation, Psychemedics misbranded its product within the meaning of 21 U.S.C. § 352(a)(1) (false or misleading labeling “in any particular”) and § 352(f) (failure to provide adequate directions/warnings for the actual intended use); its promotional claims likewise trigger § 352(q) for restricted-device advertising that is false or misleading. Introducing or delivering such misbranded devices into interstate commerce violates 21 U.S.C. § 331(a), with civil and criminal exposure under § 333. And because the devices were promoted for an uncleared intended use, they were also unlawfully marketed absent the required premarket authorization—rendering every shipment an independent FDCA offense.
Equally significant is the regulator’s silence. The Food and Drug Administration’s decades of non-enforcement did not and cannot confer legitimacy; it merely allowed ambiguity to harden into practice. As set out in the HARMS Citizen Petition, the agency’s failure to clarify the scope of 510(k) clearances under § 862.3870 enabled Psychemedics to imply “FDA clearance” for hair where none existed—a misrepresentation replicated in municipal procurements, disciplinary files, and courtroom testimony. The legal consequence is straightforward: endurance is not authorization, and marketing masquerading as science remains misbranding under § 352, prohibited by § 331, and punishable under § 333, regardless of administrative inaction.
B. Federal Employment-Law and Civil-Rights Violations
Under Title VII of the Civil Rights Act of 1964 and the Uniform Guidelines on Employee Selection Procedures (UGESP), 29 C.F.R. § 1607, employers bear a non-delegable statutory duty to ensure that all selection and testing procedures are valid, job-related, and non-discriminatory. The New York City Police Department’s reliance on hair-based immunoassay testing violates each of these federal requirements.
Scientifically, the method cannot differentiate drug ingestion from passive environmental exposure, and it produces racially correlated error rates due to melanin-dependent binding, a well-documented biochemical property that causes darker hair to retain drug compounds at higher concentrations. Legally, the Department has failed to conduct the validation studies required under UGESP 29 C.F.R. § 1607.14, which mandate demonstration of either criterion-related or content validity through objective evidence showing that the test meaningfully predicts job performance. The absence of such validation renders the method presumptively unlawful under Title VII, establishing a disparate-impact violation that disproportionately excludes Black and Brown applicants and employees from public employment based on unreliable and racially skewed results.
This practice further contravenes the Rehabilitation Act of 1973 and the Americans with Disabilities Act (ADA), both of which require that any medical or psychological testing used to assess “fitness for duty” be scientifically reliable, job-related, and consistent with business necessity. Where a test lacks scientific validity, any adverse employment action predicated upon it constitutes an arbitrary deprivation of property and liberty interests protected by the Due Process Clause, and an unequal application of law under the Equal Protection Clause of the Fifth and Fourteenth Amendments.
In sum, the NYPD’s continued reliance on unvalidated immunoassay hair testing transforms unproven science into a federal civil-rights violation—one that merges regulatory failure, employment discrimination, and constitutional deprivation into a single, enduring act of institutional misconduct.
C. State-Level Violations
Under New York Civil Rights Law § 40-c and the New York State Human Rights Law (Executive Law § 296), it is unlawful for any employer, including a municipal entity, to discriminate in hiring, promotion, or the conditions of employment on the basis of race, color, creed, national origin, sex, or disability. The New York State Human Rights Law further prohibits employment practices that result in either intentional discrimination or unjustified disparate impact against protected groups.
The New York City Police Department’s reliance on hair-based immunoassay drug testing constitutes a clear violation of these state protections. Empirical evidence has long established that such testing produces racially correlated false positives because darker, coarser hair types absorb and retain certain drug compounds—particularly cocaine and tetrahydrocannabinol (THC)—at higher rates due to increased melanin binding. This biochemical reality creates a systematic disparate impact on Black and Brown applicants and employees, disqualifying or disciplining individuals based on false indicators of drug use rather than verified ingestion.
As the Massachusetts Civil Service Commission and the First Circuit Court of Appeals recognized in Jones v. City of Boston (752 F.3d 38 [1st Cir. 2014]; 845 F.3d 28 [1st Cir. 2016]), hair testing using these methods fails to meet fundamental standards of scientific validity and has a demonstrable disparate impact on racial minorities. That precedent, though arising from a neighboring jurisdiction, underscores the incompatibility of such methods with the anti-discrimination framework of New York State law.
Moreover, under New York Executive Law § 296(1)(a), employers bear an affirmative obligation to ensure that all employment-related testing is both fair and scientifically defensible. The NYPD’s failure to validate its testing methods, despite decades of available evidence questioning their reliability, constitutes a reckless disregard of that statutory duty. Such negligence converts what might appear to be administrative error into actionable state-level civil-rights violations, implicating both institutional liability and individual accountability for decision-makers who authorized or perpetuated the practice.
In sum, the NYPD’s adoption and continued use of unvalidated hair-based drug testing contravenes New York’s statutory prohibitions against employment discrimination and violates the State’s commitment to equality under the law. By substituting pseudoscience for due process, the City has undermined both the integrity of its employment practices and the civil rights of those it purports to serve.
D. Local Violations: The New York City Human Rights Law and False Claims Act
At the municipal level, the New York City Human Rights Law (N.Y.C. Admin. Code § 8-101 et seq.) imposes one of the broadest anti-discrimination mandates in the nation, requiring liberal construction in favor of employees and extending liability beyond that available under federal or state law. The City’s continued reliance on Psychemedics Corporation’s unapproved and racially biased drug-testing methodology—long repudiated in the Jones v. City of Boston litigation—constitutes the knowing perpetuation of a discriminatory employment practice.
Under § 8-107, an employer’s use of any testing device that disproportionately excludes members of a protected class, and that cannot be justified by demonstrable business necessity, violates the statute. Because hair-based immunoassay testing demonstrably over-identifies drug use among Black and Brown populations, its continued use by the New York City Police Department represents institutionalized disparate impact.
Moreover, the City’s persistence in using this method—after receiving actual notice of its unreliability through the Palaguachi litigation, the HARMS Citizen Petition, and published scientific repudiation—constitutes deliberate indifference within the meaning of Monell v. Department of Social Services, 436 U.S. 658 (1978), as further clarified by the Second Circuit’s decision in Chislett v. New York City Department of Education, No. 24-972 (2d Cir. 2025).
In Chislett v. New York City Dep’t of Educ., No. 24-972-cv, 2025 WL 2725669, at __ (2d Cir. Sept. 25, 2025) (affirming in part and vacating in part; holding that a plaintiff’s hostile-work-environment claim could proceed to trial where record evidence showed repeated race-charged statements in employer-sanctioned trainings and workplace spillover, coupled with policy-level inaction after repeated complaints—sufficient for a jury to find a municipal “policy or custom” under Monell arising from tacit authorization/constructive acquiescence by policymakers). The court reaffirmed that a municipality’s policy may consist of inaction, and that the cumulative effect of persistent incidents and a pattern of non-intervention by senior officials can satisfy Monell’s causation requirement even absent an express rule.
Moreover, under the New York City False Claims Act (N.Y.C. Admin. Code § 7-801 et seq.), any contractor or municipality that knowingly submits, or causes the submission of, false or fraudulent claims for payment may be held liable for treble damages and civil penalties. Psychemedics’ representations that its devices were “FDA-cleared” and “validated” for hair matrices constitute material misstatements that induced ongoing contractual payments from the City. Once procurement officials and the Law Department were placed on notice through the Palaguachi litigation and the HARM Citizen Petition, they had an affirmative legal duty to suspend or terminate such contracts. Their failure to act sustains potential liability under the City’s False Claims Act and supports a finding of municipal culpability for willful blindness and administrative concealment.
E. Evidentiary Consequences
Across forums—administrative, civil, and criminal—the New York City Police Department’s hair-based drug testing as marketed by Psychemedics cannot satisfy the governing admissibility and reliability standards.
Under Frye, the proponent must show general acceptance in the relevant scientific community. Hair testing for drugs—especially cannabinoids—has no nationally accepted standards for distinguishing ingestion from environmental contamination, no uniformly accepted decontamination protocol, and no consensus cutoffs validated by independent bodies. It therefore fails Frye’s general-acceptance threshold.
Under Daubert and Federal Rule of Evidence 702, courts assess testability, peer review, known or potential error rates, the existence and maintenance of standards, and general acceptance. Hair testing for cannabinoids falters on each factor: (i) it cannot reliably test the core hypothesis—whether a detected compound reflects use rather than exposure; (ii) peer-reviewed literature documents contamination and melanin-binding artifacts rather than resolving them; (iii) no defensible, independently established error rate exists for distinguishing use from exposure; and (iv) there are no binding federal performance standards for hair matrices comparable to those for urine or blood. The absence of these guardrails precludes a finding that the methodology is “reliable” within the meaning of Daubert.
Under Rule 7.01 of the New York Rules of Evidence – Opinion of Expert Witness, New York courts continue to apply Frye’s general-acceptance test to novel scientific evidence and also scrutinize the reliability of the expert’s principles and methods. Because the hair-testing methodology lacks general acceptance and reliable, standardized procedures, expert opinions premised on such results are inadmissible in New York courts.
Finally, in employment and disciplinary settings, the Uniform Guidelines on Employee Selection Procedures (UGESP) require that any testing used to make employment decisions be validated as job-related and consistent with business necessity. Hair-based drug testing for cannabinoids has not been validated under UGESP’s criterion-related or content-validity frameworks. Reliance on such results in hiring, promotion, or discipline is therefore legally defective: it substitutes an unvalidated technique for admissible, reliable evidence and for a lawfully “validated” selection device.
Bottom line: because hair-based drug testing for cannabinoids lacks general acceptance, fails Daubert/Rule 702 and New York Rule 7.01 reliability requirements, and cannot meet UGESP validation standards in employment matters, it is inadmissible as scientific proof and unusable as a lawful basis for adverse employment action.
Taken together, these violations reveal a continuum of misconduct—federal regulatory evasion, state statutory breaches, and municipal discrimination—united by a single failure of scientific governance. The law’s purpose is to protect the public from precisely this kind of pseudoscientific capture: when agencies confuse the endurance of a method with its empirical legitimacy. Longevity cannot substitute for validation. The City’s continued defense of these tests transforms bureaucratic inertia into constitutional injury.
V. Common-Law Liability: Negligence and Negligence Per Se Against Psychemedics
Beyond statutory and regulatory violations, Psychemedics’ conduct constitutes actionable negligence and negligence per se under long-standing principles of common law. The essence of negligence lies in the breach of a duty of care owed to foreseeable parties—here, both the individual test subjects and the governmental employers who relied upon Psychemedics’ representations. From the moment the company marketed its radioimmunoassay for hair (RIAH) and enzyme-immunoassay (EIA) devices for forensic or employment use, it owed a duty to ensure that those methods were scientifically valid, properly cleared under the Federal Food, Drug, and Cosmetic Act, and administered in a manner consistent with accepted professional standards.
That duty was breached in several material respects. Psychemedics knowingly marketed and distributed immunoassay devices that were cleared by the FDA only for serum, plasma, saliva, and urine—not hair—under 21 C.F.R. § 862.3870. By expanding that clearance to a new biological matrix without supplemental premarket approval or supporting validation data, the company placed into commerce a device that could not reliably measure what it claimed to measure. It further breached its duty by misrepresenting to law-enforcement agencies, including the New York City Police Department, that its hair-testing methods were “FDA-cleared,” “scientifically validated,” and “forensically reliable.” Those representations were both false and material: they induced continued contractual payments, disciplinary reliance, and terminations based on invalid results.
Under New York law, such conduct also satisfies the elements of negligence per se, which arises when a defendant violates a statute designed to protect a particular class of persons from the very type of harm suffered. The Federal Food, Drug, and Cosmetic Act and its implementing regulations, 21 U.S.C. §§ 331–333 and 21 C.F.R. Part 807, are intended to protect consumers and downstream users from unapproved or misbranded medical devices. By violating those provisions, Psychemedics breached a legislatively defined standard of care, thereby establishing negligence per se. The foreseeable injury—the wrongful disqualification, termination, and reputational harm of public employees subjected to invalid tests—falls squarely within the protective scope of those statutes.
Moreover, Psychemedics owed an independent duty of reasonable care to third-party subjects whose samples it analyzed. New York courts have long recognized that laboratories and testing entities, though often engaged by employers or agencies, owe direct obligations to the individuals whose biological material they test. See Landon v. Kroll Laboratories, Inc., 22 N.Y.3d 1 (2013). In Landon, the Court of Appeals held that a toxicology laboratory may be liable in negligence to a test subject for failing to exercise reasonable care in the handling and analysis of biological samples. The same reasoning applies here with even greater force: Psychemedics’ negligent testing procedures and unvalidated methodology foreseeably caused wrongful terminations, loss of livelihood, and reputational damage to innocent individuals—harm of precisely the kind recognized in Landon.
Finally, Psychemedics’ ongoing failure to correct its marketing claims after being placed on formal notice through the Palaguachi and HARMS Citizen Petitions aggravates its culpability. Those filings supplied irrefutable evidence that its device lacked clearance for hair testing and that the method produced racially disparate and scientifically unreliable outcomes. Yet the company continued to tout “FDA clearance” in corporate disclosures and municipal procurement contracts. Such persistence in misrepresentation transforms ordinary negligence into willful disregard—an abdication of corporate responsibility whose consequences echo through every institution that relied upon its word.
VI. Summary and Conclusion
Taken as a whole, the record of Psychemedics’ conduct — and the City of New York’s reliance upon it — reveals a system that substituted endurance for evidence and policy for proof. For nearly three decades, an unapproved medical device was allowed to define careers, reputations, and livelihoods, despite never meeting the most basic thresholds of scientific or legal admissibility. The twin filings of the Palaguachi and HARMS Citizen Petitions now make that history undeniable: one documents the human and institutional harms; the other exposes the regulatory sleight of hand that allowed them to occur.
At the federal level, the violations are structural. By marketing and distributing enzyme-immunoassay devices for hair testing without clearance under the Federal Food, Drug, and Cosmetic Act, Psychemedics engaged in the off-label promotion of a medical device, rendering it both misbranded and adulterated under 21 U.S.C. § 331. The Food and Drug Administration’s decades-long silence — its failure to enforce or clarify the scope of its own clearances — transformed regulatory omission into systemic harm. That abdication enabled employers, including the NYPD, to treat invalid tests as dispositive evidence of misconduct or unfitness.
At the employment-law level, those same practices produced direct violations of Title VII and the Uniform Guidelines on Employee Selection Procedures. The City’s adoption of a racially biased and scientifically unreliable test created precisely the kind of disparate impact the Civil Rights Act was enacted to prevent. It further contravened the Rehabilitation Act and the Americans with Disabilities Act, which require reliable, job-related evaluation tools in determining fitness for duty. When the underlying science collapses, the due-process guarantees of the Fifth and Fourteenth Amendments collapse with it.
State and local law deepen that liability. Under New York Civil Rights Law § 40-c and Executive Law § 296, the use of an unvalidated, racially correlated test constitutes discrimination in employment. The City’s continued reliance on Psychemedics’ methodology — long after scientific repudiation and judicial warning — further violates the New York City Human Rights Law and the City’s own False Claims Act, which forbids knowingly false representations in municipal contracting. Each renewal of those contracts, and each disciplinary action predicated on those tests, perpetuated a falsehood traceable to both the manufacturer and the municipality.
Under Monell and reaffirmed in Chislett, municipal liability attaches when policymakers, with actual or constructive notice of unconstitutional or unlawful practices, fail to act to prevent or remedy them. The City’s continued use of Psychemedics’ tests — despite explicit judicial, scientific, and federal notice — satisfies that standard. This is not mere negligence; it is deliberate indifference in the constitutional sense.
At common law, the same facts establish negligence and negligence per se. Psychemedics breached its duty of care to both its governmental clients and the individuals tested by marketing an unapproved device and misrepresenting its reliability. The foreseeability of harm was neither abstract nor speculative; it was demonstrated in the ruined careers, wrongful terminations, and stigmatization of those falsely labeled as drug users. The law recognizes such injury as the predictable consequence of corporate misconduct masquerading as science.
The cumulative effect is a failure of scientific governance and a collapse of institutional ethics. When regulatory silence allows pseudoscience to masquerade as policy, civil rights become collateral damage. The remedy, therefore, is not merely compensatory but corrective — to reassert that in a constitutional democracy, evidence must precede enforcement, and law must not defer to longevity. The Palaguachi and HARMS Petitions mark the beginning of that reckoning. When regulatory silence allows pseudoscience to masquerade as policy, civil rights become collateral damage. The remedy is not merely compensatory but corrective: to reaffirm that in a constitutional democracy, evidence must precede enforcement and law must not defer to longevity.
Author’s Note
This analysis forms part of a continuing series examining how science, when left unregulated or misapplied, becomes an instrument of exclusion rather than enlightenment. The Psychemedics case, like the NYPD’s use of unlicensed psychologists and sealed records, reveals how institutional convenience often triumphs over statutory compliance. Together, the Palaguachi and HARMS Citizen Petitions establish a public record that law and policy can no longer ignore.
As these filings proceed through the administrative and judicial channels, their implications reach beyond one laboratory or one department: they question how power, science, and law intersect to define who is deemed “fit” to serve. The hope is not only accountability but restoration — of integrity to the science, of fairness to the process, and of trust to the institutions that claim to serve the public good.