The Attorney General of New Jersey and the Director of the New Jersey Division on Civil Rights jointly commenced a lawsuit against the Virtua Health System and its constituent hospitals alleging that its policy and practices concerning universal drug testing of all pregnant patients constituted unlawful discrimination based on pregnancy and sex in violation of the New Jersey Law Against Discrimination (LAD). The complaint, filed on September 26, 2024, also alleged that these drug tests have been “regularly administered” without obtaining informed consent from the patient. In addition to four counts asserting LAD violations based on pregnancy and sex, the complaint included a separate count alleging a violation of a state constitutional right of privacy enforceable under the New Jersey Civil Rights Act (NJCRA), grounded in the failure to obtain informed consent to the drug testing. It seeks relief in the form of a declaration that the defendants committed the acts and omissions alleged and that they constitute violations of the LAD and the NJCRA, an injunction against the continuation of the policy and requiring informed consent before testing were done, compensatory damages and civil penalties.
Since the Virtua hospitals are not the only hospitals in New Jersey having policies for routine drug testing on urine samples from perinatal patients, this lawsuit provides an incentive to review and evaluate those hospital policies and others in general through the lens of possible discrimination concerns. In addition, some aspects of the State’s pleading merit close attention.
Substance use during pregnancy has been recognized as a public health concern for many years. The New Jersey Supreme Court has ruled that not every instance of drug use during pregnancy, standing alone, will substantiate a finding of abuse and neglect in light of the specific language of the New Jersey statute. Unlike some states, New Jersey has not made prenatal drug use child abuse per se.
New Jersey hospitals have a statutory obligation to report suspected child abuse, which can include situations involving opioid usage in pregnant women if it poses a risk to the child. In response to requirements in the federal Child Abuse and Prevention and Treatment Act that healthcare providers involved in the delivery or care of infants affected by substance abuse from prenatal drug exposure notify the child protective services system of the occurrence such infants, the Department of Children and Families and the Department of Health adopted regulations mandating that a hospital report a “substance-affected infant” to the Division of Child Protection & Permanency (DCP&P) for possible child abuse or neglect.
“Substance-affected infant” as defined by rulemaking includes the circumstance where the mother had “a positive toxicology screen for a controlled substance or metabolite thereof during pregnancy or at the time of delivery.” The Virtua hospital policy of obtaining urine drug tests takes place in the context of a regulatory requirement to report possible substance-abused infants. That report, however, triggers the involvement of DCP&P representatives in an investigation that can be intrusive and offensive. This is a consequence of the occurrence of “false positive” results on the urine drug tests even with confirmatory retesting. The complaint describes the experience of two separate patients who became embroiled in DCP&P investigations even though their urine tests were only positive as a result of their having eaten a poppy seed bagel.
The complaint criticizes the Virtua policy providing for universal urine drug testing for all pregnant patients. It notes that this policy was at odds with recommendations made by the American College of Obstetricians and Gynecologists (ACOG) and the American Society of Addiction Medicine (ASAM) that all pregnant women should be screened for substance use disorders but using a series of verbal questions rather than urine drug testing. The 2017 Committee Opinion stated “[r]outine urine drug screening is controversial for several reasons.” These include that a positive test is not diagnostic of an opioid disorder or its severity as well as only identifying recent use. It might detect the presence of an authorized prescribed medication for pain. In addition, urine testing may not detect other substances that are often abused. Moreover, it notes that “[f]alse positive tests can occur with immune-assay testing and legal consequences can be devastating to the patient and her family.” The complaint relates similar positions by other organizations of national and international stature such as the CDC and the WHO.
Making allegations on information and belief, the complaint asserts that until 2018 Virtua had a policy in which it “did not conduct universal drug testing of all pregnant patients seeking inpatient hospital admission. Instead, it would verbally screen patients and would then decide to administer a urine drug test based on a patient’s risk of drug use.” That policy appears to have conformed to the ACOG/ASAM recommendations. Virtua revised that policy in 2018 because of the rapid increase in opioid usage in the country that has commonly been referred to as the “opioid epidemic” and to deal with the increasing number of infants being seen by Virtua clinicians exhibiting symptoms of neonatal absence syndrome (NAS) as a result of opioid usage. The complaint characterized the justifications offered by Virtua for its universal drug testing policy as “pretextual.” The complaint does not address the provisions in the Department of Health regulations that the hospital’s policies regarding cases of suspected child abuse or neglect are “reviewed by the Department and revised as required by the Department.”
Since the 2017 ACOG/ASAM endorsement of screening for substance abuse through questions and questionnaire, there have been studies published in 2023 and in 2024 identifying racial disparities and implicit bias in the implementation of question-based screening for prenatal substance abuse. The development of this perspective is a manifestation of the axiom articulated by the New Jersey courts over several decades in cases such as Schueler v. Strelinger and Morlino v. Medical Center of Ocean County that medicine is not an exact science.
The complaint states that “Virtua’s drug testing policy mandates that hospital staff obtain informed consent from all pregnant patients prior to mandatory drug testing.” That policy is consistent with New Jersey law. In Mathies v. Mastromonaco, the Supreme Court rejected the contention that “informed consent applies only to invasive procedures.” And as recognized in Estate of Behringer v. Medical Center at Princeton, issues of pre-test counseling and informed consent are involved in a patient allowing the hospital to test. The United States Supreme Court in Ferguson v. City of Charleston held that urine drug testing of pregnant women for drug use without their informed consent violates the Fourth Amendment. That ruling did not involve a private hospital but rather was in the setting of a public hospital conducting a program in conjunction with law enforcement for the detection of possible child abuse where state law provided for the prosecution of drug-using pregnant women.
While Virtua had a policy requiring informed consent to the drug testing of pregnant patients, according to the complaint, “Virtua’s staff regularly deviates from that policy.” This underscores the importance of adequate education recognizing the difference between consent and informed consent, the difference between a consent form and the consent process. A general consent form signed on admission to the hospital authorizing the practitioner to render care, including but not limited to performing labs, ordering diagnostic tests, and the like, may be sufficient to avoid a battery charge. Such forms may not be effective as evidence of an “informed consent” without a communication of material information regarding the proposed medical treatment. The form is no replacement for the process of informing a patient as to the purpose, risks, benefits, and alternatives to a proposed course of medical action. The existence of a meaningful policy to obtain patient informed consent can provide an affirmative defense to the claim of discrimination if it is generally enforced. Seemingly there will be questions of fact concerning what Virtua knew about no informed consent being obtained by staff and when it knew it and what it did about that.
The informed consent claim may be fatally flawed. The complaint accurately recites that New Jersey law requires medical providers to obtain informed consent before providing medical treatment including administering a drug test. As understood in the case law, the doctrine of informed consent requires that the hospital or medical provider make the patient aware of any information a reasonably prudent patient would find significant to make an informed decision regarding a course of treatment, procedure, or test and not what a physician might find pertinent or relevant to a given medical decision. The complaint sets forth that this information should include the medical indication for the test, information regarding the right to refuse the test and the possible outcome of positive test results “including any state-mandated reporting requirements.” However, the New Jersey Supreme Court has stated that in a negligence action predicated on lack of informed consent, a plaintiff must demonstrate that a physician “withheld medical information that a reasonably prudent pregnant woman in like circumstances would have considered material before consenting.” (Emphasis in original.) A few years earlier, the Appellate Division had held that “the doctrine of informed consent did not require defendant in this case to advise plaintiff of the FDA regulatory status” of the medical device that was going to be used in an off-label fashion. These precedents may defuse the scope of the lack of information provided to these patients.
The allegations in the third and fourth counts of the complaint seem to be an overreach. These claim a violation of the LAD because of discrimination “on the basis of sex.” More specifically, the complaint asserts that “the vast majority of Virtua’s patients seeking admission to its Labor and Delivery or High-Risk Obstetrics Units are women.” It continues that Virtua does not subject any group of patients comprised entirely or mostly of men to the “Maternal Care Manual” policies and require universal drug testing upon inpatient hospital admission. That undoubtedly is true. The universal urine drug testing of pregnant female patients is directed at determining the presence of opioid substances that could present a substantial risk to the unborn baby. While not completely impossible in an era of transgender males and uterus implantations, it seems self-evident that pregnant patients seeking admission to Labor and Delivery will necessarily be female patients. This does not resemble discrimination “on the basis of sex.”
The fifth count presents a novel claim for deprivation of civil rights with the contention that the failure to obtain an informed consent to the urine testing constitutes a violation of an individual’s right to privacy guaranteed by Article I, Paragraph 1 of the New Jersey Constitution of 1947. In 1976 in Matter of Quinlan, the Supreme Court had identified this state constitutional provision as including a right of privacy broad enough to encompass a patient’s decision to decline medical treatment under certain circumstances consistent with personal autonomy. Although subsequent cases continued to recognize a right of privacy under the state constitution in different settings, nine years later in Matter of Conroy the court reformulated the basis for the refusal of life-sustaining medical treatment as embraced within “the common-law right to self-determination” and “the doctrine of informed consent.” It is quite a stretch to transform the right to refuse medical care into an actionable affirmative claim under the Constitution to receive information. The complaint lays out another new path for a civil rights action with the contention that the failure to comply with the Virtua policy to obtain an informed consent was a violation of rights protected under state law found in the New Jersey Hospital Patients Bill of Rights, to “receive from the physician information necessary to give informed consent.” In light of the statutory interpretation of the Hospital Patients Bill of Rights in the Appellate Division’s ruling in Castro v. NYT Television “that the Legislature did not intend to create a new private right of action for a violation of the rights recognized thereunder,” this is a questionable contention.
The action filed on September 26 is not the first litigation by or on behalf of women claiming they received false positive results from eating poppy seed bagels or salad dressing and then being investigated by child protection agencies. Complaints with allegations of discrimination in violation of federal rights based on urine drug testing have been filed over the past decade in New York, Pennsylvania, California, Illinois, Alabama, Maryland and elsewhere. A case filed in upstate New York was recently dismissed and is on appeal. The New Jersey action is premised entirely on New Jersey law.
