OFFICIAL NOTICE TO THE IOWA DEPARTMENT OF HEALTH AND HUMAN SERVICES, CHILD WELFARE AND THE JUVENILE COURTS REGARDING UNCONSTITUTIONAL AND SCIENTIFICALLY UNSUPPORTED INTERPRETATION OF SWEAT‑PATCH RESULTS
Re: Formal Notice Concerning Constitutional, Scientific, and Regulatory Defects in the Interpretation of Lab Results (most notably Methamphetamine) Sweat‑Patch Results
I. PURPOSE OF THIS NOTICE
This Notice formally advises HHS and the Juvenile Court that continued reliance on sweat‑patch results reporting methamphetamine above cutoff while reporting amphetamine only as “present” or below confirmatory threshold violates:
- federal scientific standards,
- FDA‑cleared PharmChek requirements,
- SAMHSA’s parent‑plus‑metabolite rule,
- the manufacturer’s own interpretive guidance,
- Iowa Rule of Evidence 5.702,
- due‑process guarantees,
- equal‑protection guarantees, and
- constitutional protections governing state interference with the parent‑child relationship.
This Notice preserves all objections and constitutional claims for further review and request supervisory order.
II. FEDERAL AND MANUFACTURER STANDARDS REQUIRE CONCURRENT PARENT DRUG AND METABOLITE
A. SAMHSA Federal Register (2004)
Mandatory Guidelines (to confirm ingestion) require:
- Methamphetamine ≥ 25 ng, AND
- Amphetamine ≥ 10 ng,
- Both present concurrently
B. FDA‑Cleared PharmChek Standards
FDA approved the following for a 96% accurracy rate:
- Methamphetamine ≥ 10 ng, AND
- Amphetamine ≥ 10 ng,
- Both confirmed quantitatively,
- Both at above LOQ (Level Of Quantitation), and
- Both present concurrently.
C. “Present” is NOT a confirmatory category
A qualitative “present” designation:
- is not a positive,
- does not meet ingestion criteria,
- cannot be used to infer new drug use.
III. PHARMCHEK’S OWN PUBLISHED GUIDANCE CONFIRMS THESE REQUIREMENTS
PharmChek’s official interpretive materials state:
- Only confirmed positives should guide legal decisions.
- “Present” means detected below the confirmation threshold.
- Methamphetamine without meeting LOQ for amphetamine may indicate environmental exposure.
- Concentration numbers alone cannot establish timing or new use.
- Cutoff levels exist to prevent sanctions based on misinterpreted trace detections.
IV. SCIENTIFIC LITERATURE CONFIRMS SWEAT IS A CUMULATIVE MATRIX
Peer‑reviewed research establishes:
- Sweat reflects cumulative excretion, not real‑time use.
- The stratum corneum can act as a drug reservoir.
- Individuals with prior exposure may show residual secretion.
- Concentration magnitude alone cannot establish timing or intent.
Barnes et al. (2008) confirms that methamphetamine can exceed cutoff without metabolite levels to which HHS and the Court is interpreting similar results as new use.
V. CONSTITUTIONAL PRECEDENTS PROHIBIT STATE ACTION BASED ON SCIENTIFICALLY INVALID EVIDENCE
A. Substantive Due Process – Fundamental Right to Family Integrity
The U.S. Supreme Court has repeatedly held that the parent‑child relationship is a fundamental liberty interest:
- Troxel v. Granville, 530 U.S. 57 (2000)
- Santosky v. Kramer, 455 U.S. 745 (1982)
- Stanley v. Illinois, 405 U.S. 645 (1972)
- Quilloin v. Walcott, 434 U.S. 246 (1978)
- Lehr v. Robertson, 463 U.S. 248 (1983)
State interference must be:
- narrowly tailored,
- supported by reliable evidence,
- and free from arbitrary or scientifically invalid reasoning.
Reliance on “presence” as “positive” violates this standard.
B. Procedural Due Process – Right to Fair Adjudication
Due process requires:
- evidence grounded in accepted scientific standards,
- the ability to confront and challenge expert interpretation,
- decisions based on the record, not assumptions.
See:
- Mathews v. Eldridge, 424 U.S. 319 (1976)
- In re A.M., 856 N.W.2d 365 (Iowa 2014)
- State v. Hulbert, 481 N.W.2d 329 (Iowa 1992)
When the State treats “present” as “positive,” it:
- applies a non‑existent scientific category,
- bypasses the manufacturer’s rules,
- ignores federal standards,
- and deprives the parent of a meaningful opportunity to contest the evidence.
C. Equal Protection – Arbitrary and Inconsistent Application
Arbitrary application of scientific standards violates equal protection:
- Village of Willowbrook v. Olech, 528 U.S. 562 (2000)
- In re C.S., 516 N.W.2d 851 (Iowa 1994)
Parents across Iowa are subjected to:
- inconsistent interpretations,
- non‑standard laboratory categories,
- reliance on extra‑record expert testimony.
D. Separation of Powers – Courts Cannot Defer to Agency Interpretations That Contradict Science
Courts may not abdicate their fact‑finding role to an agency:
- State v. Thompson, 836 N.W.2d 470 (Iowa 2013)
- In re Detention of Hennings, 744 N.W.2d 333 (Iowa 2008)
When courts adopt HHS’s scientifically invalid interpretation, they violate separation‑of‑powers principles.
VIII. Structural Bias Created by Dr. Kadahjian’s Role as Judicial College Instructor
A further due‑process concern arises from the institutional role of Dr. Leo Kadahjian, who has served for years as an instructor at the National Judicial College, training judges, magistrates, and juvenile judicial officers on drug‑testing reliability and sweat‑patch interpretation. When the State’s preferred expert is also the individual responsible for educating the judiciary on the very scientific claims later presented in contested cases, the system creates an institutional conflict of interest that undermines the appearance of neutrality required by the Fourteenth Amendment.
Due process requires not only the absence of actual bias but also the absence of circumstances that create a “serious risk of actual bias.” Caperton v. A.T. Massey Coal Co., 556 U.S. 868, 883–84 (2009). Iowa’s own judicial‑ethics rules impose the same standard: judges must avoid even the appearance of partiality. Iowa Code of Judicial Conduct R. 51:1.2; In re Cady, 490 N.W.2d 251, 258 (Iowa 1992). These protections apply with heightened force in juvenile cases, where the State seeks to intrude upon a parent’s fundamental liberty interest. Santosky v. Kramer, 455 U.S. 745, 753 (1982).
Here, the structural problem is unavoidable. Judicial officers who later preside over evidentiary disputes involving sweat‑patch testing have been previously instructed by Dr. Kadahjian on the very methodology they are asked to evaluate. This creates systemic pressure to defer to the scientific framework taught at the Judicial College, making it exceedingly difficult for judicial officers to independently scrutinize or reject his interpretations. Ruling against the methodology presented by a Judicial College instructor risks contradicting the training endorsed by the Judicial Branch itself.
This is not an allegation of personal misconduct. It is a recognition that the dual role of educator and recurring expert witness creates an inherent appearance of partiality. When the court’s primary source of scientific instruction is also the State’s recurring expert, the neutrality of the adjudicative process is compromised. Under Caperton, such structural conditions alone are sufficient to violate due process.
VI. NOTICE OF CONTINUING VIOLATION
HHS and the Juvenile Court are hereby placed on notice that:
1. Methamphetamine‑positive / amphetamine‑present results do not meet federal ingestion criteria.
2. “Present” is not a confirmatory category.
3. Reliance on such results violates due process, equal protection, and fundamental‑rights jurisprudence.
4. All constitutional objections are preserved for Supreme Court review.
VII. DEMAND FOR COMPLIANCE
The Mother demands that:
- HHS cease treating or reporting “present” as “positive.”
- Juvenile Court decisions adhere to minimally, FDA‑cleared standards and SAMHSA standards.
- No adverse action be taken without confirmed parent‑plus‑metabolite results.
- All future sweat‑patch evidence comply with Iowa Rule 702 and Daubert.
- The Court refrain from relying on extra‑record expert testimony, especially that of Dr. Leo Kadahjian.
MEMORANDUM OF LAW
MEMORANDUM OF LAW IN SUPPORT OF NOTICE OF SCIENTIFIC AND CONSTITUTIONAL DEFECTS IN SWEAT‑PATCH INTERPRETATION
Re: Scientific, Evidentiary, and Constitutional Defects in Sweat‑Patch Interpretation
I. INTRODUCTION
This memorandum explains why sweat‑patch results showing methamphetamine above cutoff with amphetamine only “present” cannot be used as evidence of ingestion under:
- federal scientific standards,
- FDA‑cleared PharmChek requirements,
- SAMHSA guidelines,
- Iowa Rule of Evidence 5.702,
- Daubert,
- constitutional due‑process protections.
II. SCIENTIFIC AND REGULATORY FRAMEWORK
A. SAMHSA and FDA Require Parent‑Plus‑Metabolite Confirmation
Federal standards require:
- methamphetamine above cutoff, and
- amphetamine above cutoff,
- both quantitatively confirmed.
A “present” analyte does not satisfy this requirement.
B. PharmChek’s Own Guidance Confirms This
PharmChek explicitly states:
- “Present” ≠ “positive.”
- Only confirmed positives should guide legal decisions.
- Methamphetamine without amphetamine may indicate environmental exposure.
- Cutoff levels prevent sanctions based on trace detections.
C. CRL’s “Stringent Levels” Are Not FDA‑Cleared
CRL’s internal categories:
- “Present” (2–9.9 ng/mL)
are not recognized by:
- FDA,
- SAMHSA,
- PharmChek,
- forensic toxicology, despite Dr. Leo Kadahjian's misleading testimonies.
III. IOWA RULE OF EVIDENCE 5.702 AND DAUBERT REQUIRE RELIABLE SCIENCE
Under Rule 5.702, expert evidence must be:
- based on sufficient facts,
- grounded in reliable principles,
- reliably applied.
No expert testified.
No methodology was explained.
No foundation was laid.
This violates:
- Daubert,
- State v. Leahy,
- State v. Brown,
- In re M.S. (Iowa Ct. App. 2016).
IV. CONSTITUTIONAL VIOLATIONS
A. Substantive Due Process
The State may not interfere with the parent‑child relationship without reliable evidence.
See:
- Troxel,
- Santosky,
- Stanley,
- Quilloin,
- Lehr.
B. Procedural Due Process
Decisions must be based on:
- scientifically valid evidence,
- the ability to challenge the evidence,
- a fair hearing.
See:
- Mathews v. Eldridge,
- In re A.M.,
- State v. Hulbert.
C. Equal Protection
Arbitrary application of scientific standards violates equal protection.
See:
- Olech,
- In re C.S..
D. Separation of Powers
Courts may not defer to agency interpretations that contradict science.
See:
- Thompson,
- Hennings..
VIII. Reliance on Dr. Leo Kadahjian’s Contradictory Testimony From Other Cases Was Legal Error
The continued reliance by the Juvenile Court and HHS on Dr. Leo Kadahjian’s testimony from unrelated proceedings constitutes reversible error for multiple independent reasons. Dr. Kadahjian did not testify in this case, and his prior testimony is:
- extra‑record,
- inadmissible,
- scientifically inconsistent, and
- contradictory to the manufacturer’s own standards.
Using his prior statements and opinions to interpret Parent’s sweat‑patch results violates Iowa evidentiary law, due process, and constitutional protections.
A. Iowa Law Prohibits Reliance on Extra‑Record Expert Testimony
Iowa courts may not rely on evidence outside the record:
- State v. Hulbert, 481 N.W.2d 329 (Iowa 1992)
- In re A.M., 856 N.W.2d 365 (Iowa 2014)
- In re M.S., 889 N.W.2d 675 (Iowa Ct. App. 2016)
In Hulbert, the Iowa Supreme Court held that a court’s reliance on facts not in evidence is a due‑process violation.
In In re A.M., the Court reaffirmed that juvenile courts must base decisions solely on evidence admitted in the case, not on assumptions or external information.
In the Immediate Case and many others:
- Dr. Kadahjian did not testify.
- His methodology was not subjected to cross‑examination.
- His assumptions were not tested.
- His contradictions with PharmChek’s own scientist were not exposed.
- His misuse of urine testing standards was not challenged
- His misuse of hair testing standards was not challenged.
Yet the court relied on his reputation/employment credentials and prior testimony to interpret CRL’s flawed “stringent level” report.
This is textbook extra‑record reliance and is prohibited.
B. Dr. Kadahjian’s Testimony Contradicts PharmChek’s Own Published Standards
PharmChek’s official guidance states:
- A result is only a confirmed positive when both methamphetamine and amphetamine exceed cutoff thresholds.
- “Present” is not a positive.
- Methamphetamine without amphetamine meeting cutoff thresholds may indicate environmental exposure.
- Only confirmed positives should guide legal decisions.
Dr. Kadahjian’s testimony in other cases has repeatedly:
- treated “present” as “positive,”
- dismissed environmental contamination as “not typical,”
- relied on SAMHSA urine standards (which do not apply to sweat),
- ignored metabolite requirements,
- and claimed that any detection equals ingestion.
These positions directly contradict the manufacturer’s own rules.
A court cannot adopt expert testimony that contradicts the scientific method’s validated limits.
See:
- Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993)
- State v. Leahy, 748 N.W.2d 870 (Iowa 2008)
- State v. Brown, 470 N.W.2d 30 (Iowa 1991)
C. Dr. Kadahjian’s Testimony Is Internally Inconsistent and Scientifically Unreliable
In other Iowa cases, Dr. Kadahjian has:
- claimed environmental contamination is nearly impossible or umlikely,
- despite PharmChek’s (then PharmChem) own scientist (James Meeker) stating it is possible;
- claimed qualitied metabolite is irrelevant to show recent use
- despite federal standards requiring quantitate metabolite confirmation;
- claimed concentration magnitude proves new use,
- despite sweat being a cumulative matrix;
- claimed “present” equals ingestion,
- despite PharmChek stating “present” is not a positive.
Under Rule 5.702, expert testimony must be:
- reliable,
- consistent,
- scientifically grounded,
- and based on accepted methodology.
Contradictory testimony is per se unreliable.
D. Reliance on Dr. Kadahjian’s Prior Testimony Violates Procedural Due Process
Procedural due process requires:
- notice of the evidence,
- the opportunity to confront and cross‑examine witnesses,
- the ability to challenge methodology,
See:
- Mathews v. Eldridge, 424 U.S. 319 (1976)
- In re A.M., 856 N.W.2d 365 (Iowa 2014)
Because Dr. Kadahjian did not testify:
- the Parent had no opportunity to cross‑examine him,
- no opportunity to challenge his methodology,
- no opportunity to present contrary scientific authority,
- no opportunity to expose contradictions with PharmChek’s own standards.
Yet the court relied on his prior statements.
This violates due process.
E. Reliance on Dr. Kadahjian’s Testimony Violates Substantive Due Process
The U.S. Supreme Court has held that the State may not interfere with the parent‑child relationship without reliable evidence:
- Santosky v. Kramer, 455 U.S. 745 (1982)
- Troxel v. Granville, 530 U.S. 57 (2000)
- Stanley v. Illinois, 405 U.S. 645 (1972)
Using scientifically invalid, extra‑record expert testimony to restrict parental rights violates substantive due process.
F. Reliance on Dr. Kadahjian’s Testimony Violates Equal Protection
Equal protection prohibits:
- arbitrary application of scientific standards,
- inconsistent treatment of similarly situated individuals.
See:
- Village of Willowbrook v. Olech, 528 U.S. 562 (2000)
- In re C.S., 516 N.W.2d 851 (Iowa 1994)
Parents across Iowa are subjected to:
- inconsistent interpretations,
- non‑standard laboratory categories,
- reliance on contradictory expert testimony.
This is arbitrary and unconstitutional.
G. Reliance on Dr. Kadahjian’s Testimony Violates Separation of Powers
Courts may not defer to agency interpretations or expert opinions that contradict science.
See:
- State v. Thompson, 836 N.W.2d 470 (Iowa 2013)
- In re Detention of Hennings, 744 N.W.2d 333 (Iowa 2008)
By adopting Dr. Kadahjian’s scientifically invalid interpretations, the court:
- abdicated its fact‑finding role,
- substituted agency preference for scientific reliability,
- and violated separation‑of‑powers principles.
V. CONCLUSION
Sweat‑patch results showing methamphetamine above cutoff with amphetamine only “present”:
- do not meet federal ingestion criteria,
- contradict PharmChek’s own rules,
- violate Rule 702 and Daubert,
- violate due process, equal protection, and separation of powers.
The Court and HHS are now on formal notice that continued reliance on such results is unconstitutional
Reliance on Dr. Kadahjian’s contradictory, extra‑record testimony was:
- legally improper,
- scientifically invalid,
- constitutionally defective,
- and independently reversible error.