Showing posts with label Health Care. Show all posts
Showing posts with label Health Care. Show all posts

Tuesday, August 1, 2023

CHILD SUPPORT: HEALTH COVERAGE AND AGE 29 LAW


The moral of this case: draft the language carefully: If the goal is to have a parent provide health insurance for a child to age 26 or as long as permitted under the Affordable Care Act, then the language in an agreement should so specify. If the goal is to have a parent provide health insurance for a child to age 29 or as long as permitted under the Age 29 Law, then the language in an agreement should so specify.

BD v. ED, 2023 NY Slip Op 3971 - NY: Appellate Div., 1st Dept. 2023:

"HIGGITT, J.

Defendant appeals from an order of the Supreme Court, New York County (Ariel D. Chesler, J.), entered May 24, 2022, which, to the extent appealed from as limited by the briefs, denied defendant mother's motion to direct plaintiff father to pay for continued medical insurance coverage under New York State's Age 29 Law for the parties' eligible children, to reimburse the daughter for payments already made, and for counsel fees.

This appeal involves the interplay of the specific language of a stipulation of settlement and agreement between parties in a matrimonial action relating to the plaintiff father's obligation to maintain and pay for health insurance for the parties' adult daughter, and a 14-year-old New York State insurance law — the Age 29 Law (L 2009, ch 240) — that expands access to health insurance for unmarried children of insureds. The stakes here: whether plaintiff's obligation to maintain and pay for the daughter's health insurance terminated when she turned 26 years old (when her coverage as a dependent under plaintiff's employer-subsidized family-health-insurance policy terminated) or whether that obligation continues through the age of 29 (when her ability to obtain coverage pursuant to the Age 29 Law ceases). Based on the clear and unambiguous language chosen by the parties to frame plaintiff's obligation to maintain and pay for health insurance for the daughter and the demands of the Age 29 Law, we conclude that plaintiff is obligated to pay for health insurance coverage that his daughter obtained pursuant to that law.

I.

The parties married on May 26, 1996, and have two children: a daughter, T.D., and a son, A.D., who is one year younger than T.D.

In June 2013, plaintiff commenced this divorce action. On December 8, 2014, the parties entered into a so-ordered stipulation resolving their disputes. By a written stipulation of settlement and agreement (the agreement), effective February 17, 2015, the parties augmented the terms of the so-ordered stipulation.[1] Article VI of the agreement addresses child support. Section 6.3 is at the center of this appeal.

That provision, which concerns the children's medical insurance and expenses, provides that

"The Children are currently covered under [plaintiff's] medical insurance (United Healthcare Choice Plus, Health Plan [xxxxx] xxx-xxxxx-xx, Member ID: xxxxxxxxx, Group Number: xxxxxx). [Plaintiff] shall keep and maintain for the benefit of the Child such health and medical insurance plans greater than or equal to the coverage presently provided by his employer until the latter of (i) each Child is emancipated pursuant to this Agreement; (ii) each Child is no longer allowed by law to be covered under a parent's insurance."

At the time the parties entered into the agreement, T.D. was 19 years old, and was covered as a dependent under the family health insurance policy (the family policy) plaintiff maintained through his employer, which the employer subsidized.

The judgment of divorce was entered in May 2015.

II.

In March 2022, when T.D. was 26 years old, defendant sought an order, among other things, directing plaintiff to maintain and pay for health insurance for T.D., and to reimburse T.D. for any health insurance premiums she had paid. Defendant, pointing to § 6.3 of the agreement, contended that plaintiff was obligated to maintain and pay for T.D.'s health insurance until she "is no longer allowed by law to be covered under a parent's insurance"; the Age 29 Law requires health insurers to provide coverage for an unmarried child of an insured through age 29; and, therefore, the daughter was allowed by law to be covered under plaintiff's insurance.[2]

Plaintiff opposed defendant's motion, maintaining that § 6.3 is ambiguous and that the parties never contemplated that he would be responsible for the children's health insurance after they turned 26. Plaintiff asserted that it was customary for a child's health insurance to end when the child reaches age 26. Twenty-six is not a random number: under the Affordable Care Act (42 USC § 18001 et seq.), health insurers are generally required to make health insurance coverage available to the children of insureds until the children reach age 26.

In opposition to the motion, plaintiff submitted an affidavit describing the significant financial consequences to him of maintaining coverage for T.D. pursuant to the Age 29 Law, because his employer would not subsidize coverage for the daughter pursuant to that law. Plaintiff also submitted the affidavit of his counsel during the divorce proceedings, who averred that there were no discussions during his representation of plaintiff that the obligation to maintain health insurance for the children would continue after they turned 26. Counsel further averred that, although the Age 29 Law went into effect in 2009, approximately six years before the parties entered into the agreement, neither he nor plaintiff was aware of that law, and that the reference to the "law" in § 6.3 was to the Affordable Care Act.[3] Plaintiff also submitted correspondence from an individual in his employer's human resources department and an individual employed by his insurer that indicated that, upon turning 26 years old, T.D. was no longer eligible for coverage under his family plan, although she was able "to purchase continued coverage" pursuant to the Age 29 Law through the employer's plan.

In a thorough decision, Supreme Court denied defendant's motion (B.D. v E.D., 75 Misc 3d 828 [Sup Ct, NY County 2022]). The court concluded that the phrase until "each Child is no longer allowed by law to be covered under a parent's insurance" in § 6.3 is ambiguous, i.e., is susceptible of more than one meaning. The court found that the pertinent language of § 6.3 could be read to require plaintiff to maintain health insurance for T.D. as long as she is allowed by law to be a dependent under plaintiff's family plan, which would be until she turns 26. Alternatively, the language could be read to require plaintiff to maintain health insurance for T.D. through age 29 pursuant to the Age 29 Law. The court determined that "a practical and reasonable interpretation of the language is that [p]laintiff would be obligated to maintain health insurance for the children so long as they could legally be dependents under his plan" (id. at 835). Had the parties intended to place on plaintiff the burden of maintaining health insurance for T.D. pursuant to the Age 29 Law, the court observed, they could have specified so. Because it found § 6.3 ambiguous, the court considered the affidavits and other extrinsic evidence, and highlighted plaintiff's matrimonial counsel's averments that the provision of coverage after a child turned 26 was not contemplated by the parties.

III.

On her appeal, defendant argues that the agreement unambiguously required plaintiff to maintain health insurance for T.D. pursuant to the Age 29 Law because T.D. was allowed by that law to be covered under plaintiff's insurance. Defendant argues, too, that if the parties intended to limit plaintiff's obligation under § 6.3 to that imposed by the Affordable Care Act, they could have referred to that specific law. Similarly, defendant asserts that plaintiff's obligation under § 6.3 is not limited to maintaining and paying for coverage for T.D. so long as she is his dependent. Because the agreement is unambiguous, contends defendant, consideration of extrinsic evidence, such as the affidavits submitted by plaintiff and his prior counsel, is not permissible.

Lastly, defendant insists that if the agreement is ambiguous, further proceedings before the trial court are necessary to ascertain the meaning of the ambiguous language.

Plaintiff counters that the agreement unambiguously supports his reading of the document: that plaintiff was not responsible for maintaining T.D.'s health insurance after she turned 26. Plaintiff argues that, upon reaching 26 years old, T.D.'s coverage under his family policy terminated consistent with the requirements of the Affordable Care Act, and the new policy afforded to T.D. pursuant to the Age 29 Law was not provided "under [plaintiff's] insurance" within the meaning of § 6.3. Plaintiff also argues that if the agreement is ambiguous, his evidence demonstrates that the parties intended to limit his obligation to maintain health insurance for T.D. until she reached 26. Plaintiff notes that the scope of coverage under T.D.'s policy pursuant to the Age 29 Law is different from that afforded under his family policy; that she carries the policy pursuant to the Age 29 Law in her own name (as opposed to being a dependent on plaintiff's family policy), and that her policy pursuant to the Age 29 Law costs $1,300 per month and plaintiff's employer pays no portion of it. Ultimately, according to plaintiff, the policy pursuant to the Age 29 Law is an independent policy, not coverage "under [plaintiff's] insurance."

IV.

A stipulation of settlement resolving a matrimonial action is a contract, and is therefore subject to basic contract interpretation principles (see Rainbow v Swisher, 72 NY2d 106, 109 [1988]).

A contract is interpreted in accordance with the intent of the parties and the best evidence of their intent is what they express in their written agreement (Schron v Troutman Sanders LLP, 20 NY3d 430, 436 [2013]; Greenfield v Philles Records, 98 NY2d 562, 569 [2002]). Clear, unambiguous contractual terms must be enforced according to their plain meaning (Greenfield v Philles Records, 98 NY2d at 569; see Ellington v EMI Music, Inc., 24 NY3d 239, 244 [2014]); when the terms are clear and unambiguous, the court cannot look beyond the four corners of the contract (Ellington v EMI Music, Inc., 24 NY3d at 244; see Kass v Kass, 91 NY2d 554, 566 [1998]).

A contract is unambiguous if, on its face, it is reasonably susceptible of only one meaning (see White v Continental Cas. Co., 9 NY3d 264, 267 [2007]; Greenfield v Philles Records, 98 NY2d at 569-570; see also Ellington v EMI Music, Inc., 24 NY3d at 244). Whether a contract is ambiguous is determined by examining the entire agreement and considering the relation of the parties and the circumstances under which the agreement was entered, with the wording to be considered in light of the obligation as a whole and the intention of the parties manifested thereby (see Kass v Kass, 91 NY2d at 566). A court should not strain to find an ambiguity in contractual terms (see Uribe v Merchants Bank of N.Y., 91 NY2d 336, 341 [1998]).

The language at the center of the parties' dispute — "each Child is no longer allowed by law to be covered under [plaintiff's] insurance" — contains two separate phrases that have engendered controversy in this litigation. The first is "allowed by law," and the second is "covered under [plaintiff's] insurance."

With regard to the first phrase, in light of the context of the agreement as a whole, the meaning of that phrase is clear and unambiguous: plaintiff must maintain and pay for health insurance for T.D. so long as any relevant law permits coverage. To limit the law or laws applicable in § 6.3 would distort the meaning of the phrase "allowed by law" (see Consedine v Portville Cent. School Dist., 12 NY3d 286, 293 [2009]). If the parties, both of whom were represented by counsel at all relevant times, wanted plaintiff's obligation under § 6.3 to be tied to or controlled by any particular law or laws, they could have specified the normative authority that defined plaintiff's duties. They chose not to do so. Relatedly, if plaintiff wanted to limit his § 6.3 obligation, he could have bargained for express limitations; he opted to assent to broad terms.

As disclosed above, two relevant laws have been identified by the parties that inform the meaning of § 6.3: the federal Affordable Care Act and New York's Age 29 Law.

As observed by Supreme Court (and the parties do not dispute), "[u]nder the Affordable Care Act, effective September 23, 2010, plans and insurers that offer coverage to children on their parents' plan were required to make the coverage available until the adult child reaches the age of 26" (75 Misc 3d at 830 [internal citation omitted]).

New York's Age 29 Law, which was effective approximately one year before the Affordable Care Act, amended various sections of the State's Insurance Law to "expand[] access to health insurance by allowing unmarried children through age 29, regardless of financial dependence, to be covered under a parent's group health insurance policy" (Assembly Mem in Support, Bill Jacket, 2009, ch 240, Purpose [emphasis added]).[4] Specifically, the Age 29 Law "expands access to health insurance through a COBRA-like benefit for young adults by requiring commercial insurers, non-profit corporations and HMOs to offer an option to continue coverage for unmarried young adults through age 29, regardless of financial dependence, under a parent's group health insurance policy" (id., Statement of Purpose [emphasis added]).[5] Pursuant to the Age 29 Law, a parent's health insurance serves as the basis for coverage for an eligible adult child who has otherwise aged off of the parent's policy.

While T.D., upon turning 26 years old, was no longer able to obtain health insurance pursuant to the Affordable Care Act, T.D. was able to (and did) obtain health insurance pursuant to the Age 29 Law.[6] That is to say, owing to the Age 29 Law, T.D., by virtue of the fact that plaintiff has health insurance through his employer, was "allowed by law" to obtain health insurance coverage under plaintiff's insurance.

Plaintiff's contention that the parties needed to specify that plaintiff's obligation was tied to the Age 29 Law because that law is "unique" is without merit. That the Age 29 Law may be "unique" is irrelevant; however one chooses to characterize that law, it is no less a "law" under § 6.3.

The second § 6.3 phrase at issue — "covered under [plaintiff's] insurance" — is similarly clear and unambiguous. That phrase, read in light of the context of the agreement as a whole, plainly refers to health insurance coverage under plaintiff's employer's medical insurance plan (or such other insurance plan under which plaintiff obtains health insurance coverage). Like the agreement's reference to the "law," the reference to "a parent's insurance" is broad, and unrestricted by any particular qualifier (such as a specific policy or type of policy).[7]

Reading the phrase "under [plaintiff's] insurance" to mean health insurance coverage under plaintiff's employer's health insurance plan is consistent with § 6.6, which provides that, "[i]n the event that [plaintiff] is no longer able to maintain health insurance coverage for the benefit of the child through his employer or subsequent employer, [plaintiff] agrees that he shall be 100% responsible for securing and paying for the continued coverage of comparable health insurance, for the benefit of the children, for as long as required hereunder [see § 6.3]." Clearly the parties contemplated that plaintiff might not be able to maintain health insurance for T.D. under the family plan, and they planned for that contingency, requiring plaintiff to maintain health insurance for T.D. "greater than or equal to the coverage presently provided by his employer [under the family plan]" (§ 6.3) and to be "100% responsible for securing and paying for the continued coverage of comparable health insurance" (§ 6.6) (see Nomura Home Equity Loan, Inc., Series 2006-FM2 v Nomura Credit & Capital, Inc., 30 NY3d 572, 581 [2017] [court should read a contract as a harmonious and integrated whole]). To read "under [plaintiff's] insurance" in § 6.3 to mean "under [plaintiff's family plan]" would leave § 6.6 with little to no force (see Two Guys from Harrison-N.Y., Inc. v S.F.R Realty Assoc., 63 NY2d 396, 403 [1984]).

Ultimately, the practical and reasonable interpretation of § 6.3 is that, to the extent plaintiff can maintain health insurance for T.D. through his employer, he is required to do so as long as any relevant law permits coverage for T.D. As he acknowledges in his brief (and as the evidence he submitted in opposition to the motion establishes), T.D. has coverage under the same health insurance plan provided by plaintiff's employer to its employees. Thus, by virtue of the fact that plaintiff has health insurance through his employer, Age 29 Law coverage is available to T.D.

Because the agreement is clear and unambiguous, reference to extrinsic evidence is not permissible (see Consedine v Portville Cent. School Dist., 12 NY3d at 293). We note that extrinsic evidence cannot be used to cast doubt on the meaning of clear and unambiguous contractual terms (see Brad H. v City of New York, 17 NY3d 180, 186 [2011]). Moreover, that one party attaches a particular, subjective meaning to a term or phrase that differs from the term's or phrase's plain meaning does not render the term or phrase ambiguous (see Moore v Kopel, 237 AD2d 124, 125 [1st Dept 1997]; see also Vesta Capital Mgt. LLC v Chatterjee Group, 78 AD3d 411, 411 [1st Dept 2010]).

While plaintiff complains of the costs associated with a policy provided pursuant to the Age 29 Law and points out that, consistent with that law, his employer does not subsidize any portion of those costs, we enforce the plain language of the agreement regardless of any economic hardship that plaintiff may encounter (see JFK Holding Co. v City of New York, 21 NY3d 722, 728 [2013]). Of course, we may not rewrite the plain contractual language in an effort to right some perceived inequity in the parties' bargain (see Greenfield v Philles Records, 98 NY2d at 570 ["a court is not free to alter the contract to reflect its personal notions of fairness and equity"]).

In light of our determination that the aspects of defendant's motion seeking to compel plaintiff to pay for T.D.'s coverage pursuant to the Age 29 Law and to reimburse T.D. for any payments she has made for such coverage should be granted, we remand the matter to Supreme Court to consider anew that aspect of defendant's motion seeking attorneys' fees.

Accordingly, the order of the Supreme Court, New York County (Ariel D. Chesler, J.), entered May 24, 2022, which, to the extent appealed from as limited by the briefs, denied defendant mother's motion to direct plaintiff father to pay for continued medical insurance coverage under New York State's Age 29 Law for the parties' eligible children, to reimburse the daughter for payments already made, and for counsel fees, should be modified, on the law, to grant defendant's motion to the extent of directing plaintiff to pay for Age 29 Law health insurance for the parties' daughter, T.D., until she is no longer eligible for coverage pursuant to that law, and to reimburse T.D. for payments she has made for such coverage, the matter remanded for further proceeding consistent with this decision and order, and otherwise affirmed, without costs.

Order, Supreme Court, New York County (Ariel D. Chesler, J.), entered May 24, 2022, which, to the extent appealed from as limited by the briefs, denied defendant mother's motion to direct plaintiff father to pay for continued medical insurance coverage under New York State's Age 29 Law for the parties' eligible children, to reimburse the daughter for payments already made, and for counsel fees, modified, on the law, to grant defendant's motion to the extent of directing plaintiff to pay for Age 29 Law health insurance for the parties' daughter, T.D., until she is no longer eligible for coverage pursuant to that law, and to reimburse T.D. for payments she has made for such coverage, the matter remanded for further proceeding consistent with this decision and order, and otherwise affirmed, without costs.

All concur.

THIS CONSTITUTES THE DECISION AND ORDER OF THE SUPREME COURT, APPELLATE DIVISION, FIRST DEPARTMENT.

[1] The agreement was incorporated in but not merged into the judgment of divorce.

[2] Additionally, defendant wanted the order to direct plaintiff to secure health insurance pursuant to the Age 29 Law for A.D., if and when he is eligible for the benefits of that law. Because A.D.'s eligibility for coverage pursuant to the Age 29 Law have neither been conceded by the parties nor established by the record adduced before the motion court, we do not pass upon whether plaintiff has any obligation to maintain and pay for health insurance for A.D. pursuant to that law.

[3] Plaintiff cross-moved for counsel fees and costs. The cross-motion was denied, and plaintiff did not appeal from that determination.

[4] The Age 29 Law amended, among other provisions, Insurance Law §§ 3216 (commercial insurers providing individual health insurance policies), 3221 (commercial insurers providing group health insurance policies), and 4304 and 4305 (not-for-profit corporations and HMOs) to require that the age 29 option be made available to the relevant individuals.

[5] With respect to commercial insurers that provide group health insurance coverage, the legislation aimed to provide "an option to continue coverage to unmarried children who have `aged off' of their parents' group health insurance policies. The `dependent children' may continue to be covered under their parents' group policy through age 29" (id., Summary of Provisions).

[6] To qualify for a policy pursuant to the Age 29 Law, the unmarried child must live, work or reside in New York State, and must not be insured or eligible for coverage under any employer-sponsored insurance offered by the child's employer (id., Summary of Provisions).

[7] Plaintiff notes that § 6.3 opens with an express reference to his family plan and, therefore, the parties expressed their intention that his obligation was limited to providing T.D. coverage under that particular policy. That reference was to the policy under which the children were then "currently" covered; the remainder of § 6.3 and §§ 6.4 and 6.6 make plain that plaintiff's obligation was not linked to any particular policy."

Saturday, July 8, 2023

SEEKING TO TREAT A PATIENT OVER THEIR OBJECTIONS


Because of some reason or issue in the parent/child relationship, the patient's daughter refused to be the decision maker in her mother's care.

KINGS COUNTY HOSP. v. MR, 2023 NY Slip Op 50647 - NY: Kings Supreme Court 2023:

STEVEN Z. MOSTOFSKY, J.

Kings County Hospital (KCH) filed an application to treat M.R. over her objection under the Family Healthcare Decisions Act, Public Health Law (PHL) § 29-cc. The statute permits the hospital to bring this special proceeding for M.R.'s treatment. (§ 2994-r).

M.R. is a 62-year-old woman who suffers from, among other things, Schizoaffective Disorder, Borderline Personality Disorder, and Stage 5 End Stage Chronic Kidney Disease. She is known to this Court from having previously been the subject of several prior hearings for treatment over objection under both the Family Health Care Decisions Act and 14 NYCRR 527.8, as an involuntary psychiatric patient under Mental Hygiene Law Article 9. On each occasion, the Court authorized treatment.

There was testimony at a prior Court hearing in 2020 that M.R. knew she had 5% kidney function. For each hospitalization since, a doctor testified that without regular dialysis, M.R. could die. She has stated she wants to live despite her refusal to undergo dialysis. She is alive today.

KCH brough this application while M.R. was still being held under Article 9 of the MHL at Kingsboro Psychiatric Center, though physically at Kings County Hospital receiving medical treatment. On May 9, 2023, KCH administered dialysis to M.R. on a "life-saving" basis. The hospital took labs that revealed M.R.'s tenuous health. They indicated that M.R. was at risk of cardiac arrest, renal toxicity, seizure, and other conditions if she did not receive dialysis. KCH then filed an Order to Show cause under 14 NYCRR 527.8 to treat M.R. over her objection on May 12, 2023.

When Kingsboro unexpectedly decided to discharge her from its psychiatric unit while M.R. was still a medical patient at KCH, KCH moved to amend its original application to now proceed under the Family Healthcare Decisions Act, Public Health Law (PHL) § 29-cc. This Court granted the motion.

In this proceeding, KCH seeks to treat M.R. with hemodialysis, to conduct a procedure known as a Permacath to facilitate future dialysis, and to administer psychiatric medication and laboratory tests, over M.R.'s objection.

Here, proceeding under the PHL, the hospital determined that M.R. lacked decision-making capacity. PHL § 2994-b. It identified M.R.'s daughter, C.C., as a suitable surrogate. PHL § 2994-d(1). C.C. testified that her mother never indicated a wish to die and has never been suicidal. C.C. testified that her mom wants to get better, but "doesn't understand that [her condition] is severe and that she will die if she does not get treatment." The Court has the unenviable responsibility to determine the fate of a patient who wants to live but refuses treatment necessary to remain alive.

M.R. did not testify. A representation was made to the Court that her physical condition precluded her from testifying.

C.C. testified on June 15, 2023, that she did not feel comfortable acting as her mother's surrogate. She refused the appointment. Unfortunately, the Court cannot appoint her.

The Court heard testimony from M.R.'s treating doctors. One of those physicians was Dr. Daniel Buchnea, a pulmonologist and critical care physician. Dr. Buchnea did not openly object to M.R. receiving dialysis and other treatments over her objection. But he raised concerns about the balance between its benefits and risks. The hospital empaneled an ethics committee to consider the impact of the treatment on M.R. The committee, probably established for cases like M.R.'s, made no ethical recommendation, and inexplicably punted the decision to M.R.'s daughter, who now refuses to be surrogate.

But on June 12, 2023, Dr. Buchnea treated M.R. and wrote a note in the medical record. The note said "[M.R.] does not wish to die and wants to do dialysis so she can breathe better today." Whether or not she has the capacity to agree to or refuse treatment, she has the innate capacity to signify she doesn't want to die. In fact, her failure to have regular dialysis, as opposed to the status quo where she is only receiving dialysis on an emergent basis once every eight to ten days, affects her brain and cognitive ability. If she continues dialysis, it is possible she could regain cognition and take medication to gain full capacity.

The statute permits the hospital to treat M.R. as requested. Section 2994-g of the PHL governs treatment over objection for patients like M.R. who do not have a surrogate. The statute delineates the steps the hospital must take to provide routine or major medical treatment to a patient without a surrogate. PHL § 2994-g. Based on the testimony and medical records, the Court authorizes the hospital to treat M.R. within the requirements listed under each subsection. PHL § 2994-g(3)(a-b); PHL § 2994-g(4)(i-iii). The Court holds on clear and convincing evidence that the hospital may treat M.R. based on her lack of capacity and ability to balance the treatment's benefits and risks. Additionally, the treatment is in M.R.'s best interests. She wants to live and will die without it.

The hospital may provide dialysis to her three times a week, if necessary, with light sedation. It may also place a new permacath and treat her with the psychotropic medications listed by Dr. Tusher in his affidavit. M.R. may not be restrained unless a cardiologist is present.

It is ORDERED that KCH may treat M.R.over her objection in accordance with the Court's findings. The treatment is in her best interest, the benefits of the treatment outweigh the risks, and is the least restrictive alternative. It is further ORDERED that the hospital shall notify M.R.'s daughter, C.C., before performing any medical procedures not listed above."

Thursday, September 30, 2021

COVID TREATMENTS AND THE COURT


Cammarano v. Staten Island University Hosp., Date filed: 2021-09-20, Court: Supreme Court, Richmond, Judge: Justice Ralph Porzio, Case Number: 85169/2021:

"HISTORY

This action was brought by Donald James Cammarano, (hereinafter “Plaintiff/advocate”) as the son and advocate for Donald Anthony Cammarano (hereinafter “Patient”) on September 7, 2021, seeking a medical declaratory judgment and emergency order compelling Staten Island University Hospital- Northwell Health (hereinafter “SIUH/Northwell”) to comply with a prescription for Ivermectin to treat the patient’s COVID-19. According to Plaintiff/advocate, his father, the patient, tested positive for COVID-19 on or about July 23, 2021 and was admitted to SIUH/Northwell on July 28, 2021. While in the ICU, the patient received the hospital’s COVID-19 treatment protocol of Remdesivir, antibiotics, and steroids. Plaintiff/advocate stated in his affidavit that on August 11, 2021 the patient, his father, stated that he wanted to be prescribed Ivermectin. The following day, August 12, 2021, Plaintiff/advocate stated that Dr. Michael Chalhoub, the Chief of the ICU at Staten Island University Hospital, agreed to prescribe Ivermectin for the patient. Despite this, the Plaintiff/advocate was subsequently informed that the hospital refused to prescribe and administer the prescription. Instead, Dr. Michael Turner, MD, a doctor from Washington State and not associated with Northwell Health, prescribed Ivermectin for the patient. However, SIUH/Northwell refuses to administer the prescription as they claim Ivermectin is not the appropriate course of treatment for the patient.

SPECIAL PROCEEDING

The Plaintiffs brought this Special Proceeding and Order to Show Cause for a medical declaratory judgment and emergency preliminary injunction on September 7, 2021 asking this Court to compel SIUH/Northwell to administer Ivermectin to the patient. This Court initially denied the interim relief which sought SIUH/Northwell to administer Ivermectin as “ordered by his treating physicians” based upon the failure to timely file an affirmation pursuant to 22 NYCRR 202.7. The Court heard the matter on September 9, 2021, and again did not order SIUH/Northwell to administer Ivermectin. The matter was adjourned for full briefing and oral arguments of the Order to Show Cause on September 14, 2021.

Though the Court is sympathetic to the Plaintiffs, there has been no admissible evidence submitted that Ivermectin is an effective or an approved treatment for COVID-19. The Plaintiffs failed to present any affidavits from Dr. Michael Turner, the prescribing physician, or any other expert, recommending Ivermectin to the patient or attesting to Ivermectin as an effective treatment for COVID-19. Plaintiffs, in support of the application, submitted inadmissible news articles and orders from similar cases, without any statutory or case law authority. This decision will address the preliminary injunction, the fundamental right to medication, the right to try and the compassionate use of medication.

The Preliminary Injunction

In order for the Court to grant a preliminary injunction, the Plaintiff must show (1) a likelihood of success on the merits; (2) irreparable harm in the absence of the preliminary injunction; and (3) the balance of the equities in favor of the Plaintiff. See W. T. Grant Co. v. Srogi, 52 NY2d 496, 517 (1981). “A mandatory injunction, which is used to compel the performance of an act, is an extraordinary and drastic remedy which is rarely granted and then only for unusual circumstances where such relief is essential to maintain the status quo pending trial of the action. Matos v. City of New York, 21 A.D.3d 936, 937 [2d Dept. 2005].

It is the Plaintiffs’ burden to show a likelihood of success on the merits of the case and it must be clear from undisputed facts. See McLaughlin, Piven, Vogel, Inc. v. W.J. Nolan & Co., 114 AD2d 165, 173 [2d Dept. 1986]; Family Affair Haircutters, Inc. v. Detling, 110 AD2d 745, 747 [2d Dept. 1985]. The Plaintiffs have failed to show a likelihood of success on the merits, as they have not shown that Ivermectin would be effective in treating the patient, nor have they shown that the Court has any legal authority to order their requested relief.

Further, Plaintiffs have failed to show that they would suffer irreparable harm in the absence of the preliminary injunction. The alleged harm must be shown by the Plaintiff to be “imminent, not remote or speculative.” See Golden v. Steam Heat, 216 AD2d 440, 442 [2d Dept. 1995]. In this case, Plaintiffs have only speculated that the Ivermectin treatment would be effective for the patient. The Court, on speculation alone, cannot find that the patient would suffer irreparable harm in the absence of the preliminary injunction.

Finally, the Plaintiffs have failed to show a balance of the equities in their favor, as they must show that the irreparable harm will outweigh the harm to the defendants. See McLaughlin, Piven, Vogel, Inc. v. W.J. Nolan & Co., 114 AD2d 165, 174 [2d Dept. 1986]. This Court agrees that “public policy should not and does not support allowing a physician to try any type of treatment on human beings. Rather, public policy supports the safe and effective development of medications and medical practices.” See Smith v. W. Chester Hosp. LLC, 2021 Ohio Misc. LEXIS 103 [Ohio Court of Common Pleas Gen. Div. Butler Cty. September 6, 2021]. The goal of providing assistance to patients during the COVID-19 pandemic should not “overcome thoughtful, evidence-based judgment…” American Medical Association, Prescribing Medications Responsibly in a Pandemic, Code of Medical Ethics Opinion 1.2.11 (August 21, 2021), available at www.ama-assn.org/delivering-care/ethics/prescribing-medications-responsibly-pandemic [last accessed Sept. 20, 2021]. This Court will not overrule the clinical judgment of the patient’s physicians, as doing so may cause severe harm to those physicians, SIUH and Northwell Health.

Fundamental Right to Medication

The news surrounding the use of Ivermectin to treat COVID-19, without any data or peer-reviewed proof, reminds this court of the use of Laetrile, a drug that gained popularity, but was not federally approved for the treatment of cancer. Laetrile, also known as amygdalin, is made from the pits of fruits and is found naturally in plants. The drug was ultimately banned by the United States Food and Drug Administration (hereinafter “FDA”) as it showed no anticancer activity, and the side effects mirror the symptoms of cyanide poisoning. (“Laetrile/Amygdalin (PDQ®)-Health Professional Version,” National Institute of Health, National Cancer Institute, www.cancer.gov/about-cancer/treatment/cam/hp/laetrile-pdq, [last accessed Sept. 20, 2021]). The use of the unapproved drug Laetrile for terminally ill patients was addressed by the United States Supreme Court in United States v. Rutherford.

In 1975, terminally ill cancer patients brought an action to “enjoin the Government from interfering with the interstate shipment and sale of Laetrile, a drug not approved for distribution under the act.” United States v. Rutherford, 442 US 544, 556 [1979]. The question addressed in the Rutherford case was “whether the Federal Food, Drug and Cosmetic Act precludes terminally ill cancer patients from obtaining Laetrile, a drug not recognized as ‘safe and effective’…” Id. at 546. The Court stated, “for the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit…” Id. at 556. The Supreme Court in Rutherford ultimately held that there was no explicit exception for terminally ill patients to use a drug that was not approved as safe or effective. Id.

The Supreme Court, in analyzing a drug’s effectiveness under the Federal Food, Drug and Cosmetic Act, noted:

“Moreover, there is a special sense in which the relationship between drug effectiveness and safety has meaning in the context of incurable illnesses. An otherwise harmless drug can be dangerous to any patient if it does not produce its purported therapeutic effect. See 107 Cong. Rec. 5640 (1961) (comments of Sen. Kefauver). But if an individual suffering from a potentially fatal disease rejects conventional therapy in favor of a drug with no demonstrable curative properties, the consequences can be irreversible. See, e. g., 42 Fed. Reg. 39768, 39787 (1977) (statement of Dr. Carl Leventhal, Deputy Director of the Bureau of Drugs, FDA, and Assistant Professor of Neurology and Pathology at Georgetown University).” United States v. Rutherford, 442 US 544, 556 [1979].

The United States Court of Appeals for the District of Columbia Circuit addressed drug regulation and the use of unapproved drugs for the terminally ill in its decision in Abigail Alliance for Better Access to Dev. Drugs v. Von Eschenbach, 378 US App DC 33, 495 F3d 695, 702 [2007]. In Abigail the Court noted that the FDA and Congress had programs available for terminally ill patients, to “provide early access to promising experimental drugs when warranted.” The use of investigational drugs by patients not participating in clinical trials may be approved for the treatment of “serious or immediately life-threatening diseases if there exists no comparable or satisfactory alternative drug or other therapy.” The Court analyzed the FDA’s procedure for access to experimental drugs, but in citing Rutherford, stated that someone in desperate need of curative treatments can have their death “hastened by the use of a potentially toxic drug with no proven therapeutic benefit.” Abigail at 713. The FDA’s policy of limiting access is rationally related to a legitimate state interest in protecting patients from “potentially unsafe drugs with unknown therapeutic effects.” Abigail at 713. In Abigail, the Court ultimately held that terminally ill patients had no fundamental due process right to access experimental drugs.

Ivermectin and Off-Label Use

Upon the Court’s research, the FDA has only approved Ivermectin to treat people with intestinal strongyloidiasis and onchocerciasis, conditions that are caused by parasitic worms. (Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, U.S. Food & Drug Administration,_www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 [last accessed Sept. 17, 2021]). In the instant matter, Ivermectin is being prescribed to treat the patient’s COVID-19 as an off-label use. Unapproved use of an FDA approved drug is often called “off-label” use, meaning that the drug is being used for a disease or condition that it is not approved to treat. (“Understanding Unapproved Use of Approved Drugs Off Label,” U.S. Food & Drug Administration, www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label [last accessed Sept. 20, 2021]). Doctors often have the ability to prescribe drugs to their patients for “off-label use” if they feel that it may benefit a patient. (“What to Know About Off-Label Drug Use,” Medical News Today, www.medicalnewstoday.com/articles/off-label-drug-use#reasons-for-use, [last accessed Sept. 20, 2021]).

Off-label prescriptions are an “integral part of contemporary medicine,” however, these prescriptions can harm patients when “an off-label use lacks a solid evidentiary basis.” (“Off-Label Prescribing: A Call for Heightened Professional and Government Oversight,” J Law Med Ethics, www.ncbi.nlm.nih.gov/pmc/articles/PMC2836889/ [last accessed Sept. 20, 2021]). Responsible off-label prescribing requires physicians to “(1) evaluate whether there is sufficient evidence to justify an off-label use; (2) press for additional information and research when adequate evidence is lacking; and (3) inform patients about the uncertainties and potential costs associated with off-label prescribing.” Id. When uncertainty exists about the benefits of off-label applications, “patients are at risk of receiving harmful or ineffective treatments.” Id. The FDA has not “authorized or approved Ivermectin for use in preventing or treating COVID-19.” (Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, U.S. Food & Drug Administration,_www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 [last accessed Sept. 17, 2021]). The alleged successes of Ivermectin are merely anecdotal at this time, however, the FDA confirms that “currently available data do not show Ivermectin is effective…” Id.

The Court finds the affidavits submitted on behalf of SIUH/Northwell by its employees, Dr. Neville Mobarakai and Dr. Dany Elsayegh, to be persuasive and notes that the patient is not suffering from an active COVID-19 infection, but rather complications from COVID-19, specifically bacterial pneumonia. Per these doctors, bacterial pneumonia is not treated by Ivermectin. In fact, both doctors claim that since Ivermectin is not clinically warranted for the patient’s current condition, “it would be unethical to provide such treatment to Donald Anthony Cammarano.” See Defendants’ Exhibits A and B. Further, this Court understands that deviation from accepted medical practices is an essential element of medical malpractice and per the FDA, there is no current evidence to justify off-label use of Ivermectin at this time. See Poter v. Adams, 104 AD3d 925, 926, 961 NYS2d 556, 558 [2d Dept. 2013] and (Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, U.S. Food & Drug Administration,_www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 [last accessed Sept. 17, 2021]). As such, this Court will not require any doctor to be placed in a potentially unethical position wherein they could be committing medical malpractice by administering a medication for an unapproved, alleged off-label purpose.

Right to Try and Expanded Access

Though not expressly argued by the parties in this matter, the Court has considered options available to the patient through the Right to Try Act and the FDA’s expanded use program. The “Right to Try Act” was signed into law on May 30, 2018. The law permits patients who have been diagnosed with life-threatening diseases or conditions who have tried approved treatment options and are not able to participate in a clinical trial to access unapproved medical treatments. The FDA allows patients to have access to “eligible investigational drugs” if they meet certain criteria, such as, being diagnosed with a life-threatening disease, they’ve exhausted approved treatment options, and they provide written informed consent. (“Right to Try,” US. Food and Drug Administration, www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try [last accessed Sept. 20, 2021]).

In addition to “Right to Try,” patients may have access to expanded use, also known as compassionate use, of experimental or unapproved medical products outside of clinical trials. This is available when there is “no comparable or satisfactory therapy options” available. Expanded use may be available to a patient when a patient has a serious, life threatening disease or condition; there is no comparable drug or therapy; a clinical trial is not possible; the benefit justifies the potential risks of treatment; and providing the product will not interfere with investigational trials. (“Expanded Access,” US. Food and Drug Administration, www.fda.gov/news-events/public-health-focus/expanded-access [last accessed Sept. 20, 2021]).

After careful consideration, this Court finds that these programs to try medications are not applicable in this case. Per the affidavits provided by SIUH/Northwell, the patient is currently diagnosed with bacterial pneumonia and does not have an active COVID-19 infection. There was no evidence submitted that the patient attempted to obtain drugs undergoing clinical trials, pursuant to the Right to Try Act or under the FDA’s expanded use program. In any event, as the Courts have previously found that there is not a fundamental right for a patient to use new or experimental drugs, this Court will not interfere with the regulations of the FDA and order the administration of Ivermectin to the patient over the objection of the Defendants.

CONCLUSION

This Court is not commenting on whether Ivermectin will ever be an effective or approved treatment for COVID-19, nor will it medicate from the bench. This Court will not order a hospital to provide a patient with an unproven, unapproved treatment that could potentially have detrimental effects on him due to his fragile health. The Plaintiffs have failed to present expert support for the off-label use of Ivermectin to treat the patient’s current condition. Based upon the foregoing, the Plaintiffs’ request for a declaratory judgment and order to compel Staten Island University Hospital- Northwell Health administer Ivermectin is denied."

Friday, April 18, 2014

NY FAMILY HEALTH CARE DECISIONS ACT

When there is a lack of advance planning and health directives, New York's Family Health Care Decisions Act (FHCDA)[1] establishes the authority of a patient's family member or close friend to make health care decisions for the patient in cases where the patient lacks decisional capacity and did not leave prior instructions or appoint a health care agent. This "surrogate" decisionmaker would also be empowered to direct the withdrawal or withholding of life-sustaining treatment when standards set forth in the statute are satisfied.

For more information, visit the Family Health Care Decisions Act Information Center

Wednesday, April 16, 2014

TODAY IS NATIONAL HEALTHCARE DECISIONS DAY

Today is the 7th Annual National Healthcare Decisions Day!

Talk about advance care planning. Free info and tools at: www.nhdd.org

Or see an attorney for estate planning, etc.

Wednesday, March 26, 2014

APRIL 16 - NATIONAL HEALTHCARE DECISIONS DAY

National Healthcare Decisions Day exists to inspire, educate & empower the public & providers about the importance of advance care planning. National Healthcare Decisions Day is an initiative to encourage patients to express their wishes regarding healthcare and for providers and facilities to respect those wishes, whatever they may be.

National Healthcare Decisions Day

Friday, February 28, 2014

HEALTH CARE FRAUD

A link to this newsletter from the CPA firm of Israeloff, Trattner & Co., PC was of interest to me as a result of the work I am beginning to do in the area of no-fault claims and the issue of necessary medical treatment:

Diagnosing health care fraud — What employers need to know