Click here to view the PRN Forum response to this filing.
UNITED STATES DISTRICT COURT - DISTRICT OF KANSAS
PAIN RELIEF NETWORK, on behalf of patients of Stephen J. Schneider, D.O.,
Plaintiff, [Uzo L. Ohaebosim, Attorney for Plaintiff; 510 N. Main; Wichita, KS 67214; 316-261-5400]
vs.
THE STATE OF KANSAS, THE KANSAS STATE BOARD OF HEALING ARTS, MICHAEL MUKASEY, in his official capacity as United States Attorney General; ERIC F. MELGREN, in his official capacity as the United States Attorney for the District of Kansas, and THE UNITED STATES DEPARTMENT OF JUSTICE,
Defendants.
VERIFIED COMPLAINT FOR DECLARATION OF RIGHTS AND FOR TEMPORARY RESTRAINING ORDER PURSUANT TO FED.R. CIV.P. 65(b) — (DECLARATORY AND INJUNCTIVE RELIEF: MOTION FOR TEMPORARY RESTRAINING ORDER OR PRELIMINARY INJUNCTION AND PERMANENT INJUNCTION)
[This document, with Footnotes included, in PDF format]
INTRODUCTION
1. This is an action brought by the Pain Relief Network, on behalf of patients of Dr. Stephen J. Schneider, seeking declaratory and injunctive relief on an emergency basis and accordingly petitioning this Court as follows:
(A) to declare palliative care (in the form of FDA-approved pharmaceuticals) a fundamental right of patients in severe pain; and, in order to make that declaration effective,
(B) to order the State of Kansas, through its agency, the Kansas State Board of Healing Arts (KASBHA), to reinstate Dr. Stephen J. Schneider's medical license, suspended as a result of a summary hearing before an administrative law judge (ALJ) without due process, until such time as Dr. Schneider’s federal case (no. 07-10234-WEB, in the U.S. District Court for the District of Kansas, Wichita Docket) is adjudicated – such an order allowing the Schneider clinic to remain open under Kansas law;
(C) to order the State of Kansas, through its agency, the KASBHA, to affirm that it has no objection to Dr. Joseph M. Sack’s taking over the operation and management of the Schneider Clinic until such time as said federal case has been adjudicated;
(D) to appoint a special master to oversee the reopened clinic’s financial operations so as to protect it from charges of “money laundering”;
(E) to enjoin the U.S. Department of Justice (USDoJ) from taking further harassing actions against said clinic in its operation under the direction of Dr. Joseph M. Sack (who holds a valid license from the KASBHA), said actions including, but not limited to, confiscation of patient files and any other actions that impede the clinic’s operations and its treatment of patients in severe pain; and
(F) to order the USDoJ to return to the reopened clinic the entirety of the originals of all patient files in the Schneider clinic that were confiscated, in whole or in part, in violation of federal law.
Thus, this action seeks declaratory relief in the form of an affirmation of a fundamental right; injunctive relief in the form of temporary restraining orders, preliminary injunctions, and permanent injunction against the State of Kansas; injunctive relief in the form of appointment of a Special Master to oversee operations of the reopened clinic; and injunctive relief in the form of temporary restraining orders, preliminary injunctions, and permanent injunctions against the USDoJ.
2. The grounds for Plaintiff’s allegations are as follows:
(A) the Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C.A. § 801 et seq., as regards medical pain management physicians, is fatally arbitrary and does not meet the standard of what constitutes law.1 Medical pain management practitioners are grossly unequal before the law and subject to selective prosecution based on arbitrary and unjustifiable standards.
(B) the CSA violates Plaintiff’s members’ right of due process guaranteed by the Fifth and Fourteenth Amendments to the U.S Constitution;
(C) the CSA violates Plaintiff’s members’ right of equal protection under the law as guaranteed by the Fourteenth Amendment to the U.S. Constitution;
(D) the CSA violates Plaintiff’s right to be governed under the laws of the State of Kansas, free from unlawful intrusion by the U.S. Government, as guaranteed by the Tenth Amendment to the U.S. Constitution;
(E) the CSA violates Plaintiff’s members’ right to be free from cruel and unusual punishment as guaranteed by the Eighth and Fourteenth Amendments to the U.S. Constitution;
(F) the CSA violates Title II of the Americans with Disabilities Act (ADA §§ 201 et seq. [42 U.S.C. §§ 12131 et seq.]); and
(G) 18 USC § 1347 is unconstitutional because, inter alia, it impermissibly allows federal government intrusion into the physician-patient relationship and matters of medical practice.
3. Plaintiff brings this action at this time not only because the ultra vires conduct of employees of the KASBHA and of the USDoJ has placed their very lives in immediate jeopardy, but also because a Kansas district court has refused – on two occasions – to hear patients’ emergency request for injunctive relief outside of the presence of the KASBHA. Since this repeated refusal to hear this request, several medically vulnerable people have been hospitalized, their prognoses unknown. All Wichita hospitals, the local medical society, and the KASBHA itself have acknowledged the emergency situation that now exists as a result of the State’s actions.
4. Plaintiff is seeking emergency relief in this Court because Schneider clinic patients are now, as a direct result of the State’s actions against them, unable to secure appropriate treatment for their pain anywhere in Kansas. Under Kansas law, the Schneider clinic cannot remain open so long as Dr. Schneider’s license is suspended. Thus, the essence of Plaintiff’s request here is to restore the status quo obtaining prior to the ALJ’s decision to suspend Dr. Schneider’s license at the behest of the KASBHA. As Dr. Schneider is incarcerated (on unproved federal allegations), he is unable to practice medicine. The suspension of his license by the State of Kansas served no legitimate governmental interest and answered to no law enforcement necessity, but rather manifested wanton disregard for pain patients, harmed them irreparably, and continues to do so. This much should be clear: Plaintiff’s request is eminently reasonable, for there is no danger whatever that Dr. Schneider can practice medicine even with a restored license, but, so long as his license is suspended, patients of the Schneider clinic cannot secure the care they need. On the other hand, the position of the KASBHA and the USDoJ is absurd: the suspension of Dr. Schneider’s license is nothing more than a knee-jerk reaction to political pressure and does nothing more than cause harm to those least able to bear it.
PARTIES
5. Plaintiff Pain Relief Network (PRN) is a privately funded nonprofit, 501(c)(3) corporation, incorporated in the State of New York. PRN is concerned with civil liberties, as well as legal and ethical issues raised by the application of the CSA to the practice of pain medicine. PRN was founded by Siobhan Reynolds, a pioneer in the fight for the civil rights of Americans in pain. Ms. Reynolds is also the mother of a teenaged son who suffers from chronic pain, and the widow of his father who died, at the age of 50, as a result of untreated pain. PRN is concerned with the destruction of lives, liberty, and property of Americans in pain and the physicians who treat them with “controlled substances”.
6. Defendant Kansas State Board of Healing Arts was created to protect the public by authorizing only those persons who meet and maintain certain qualifications to engage in the health care professions regulated by this Board. Also, to utilize the least restrictive yet effective means to protect the public from incompetence, unprofessional conduct or other proscribed practice by persons who have been granted authority to practice in this State and from unauthorized practice by persons and entities who have not been granted authority to practice in this State.
7. Defendant United States Department of Justice is an executive agency headed by the U.S. Attorney General. Defendant Michael Mukasey is the Attorney General of the United States. He is charged with supervising the activities of the United States Department of Justice (USDoJ) and its various subdivisions, including the Drug Enforcement Administration (DEA). Attorney General Mukasey is being sued in his official capacity. Defendant Eric Melgren is United States Attorney for the District of Kansas. He is being sued in his official capacity.
8. Defendant State of Kansas, whose sovereignty is limited only by the U.S. Constitution, is one of the federated States of the United States of America.
JURISDICTION AND VENUE
9. This Court has jurisdiction over this action under 28.U.S.C. § 1331 [federal question]. Plaintiff’s right to judicial review is secured by the Fifth and Fourteenth Amendments to the U.S Constitution.
10. Venue for this action properly lies in this Court under 28 U.S.C. § 1391(e). On information and belief, all members of the KASBHA reside within this judicial district, as do patients of Dr. Stephen J. Schneider, on whose behalf the Pain Relief Network brings this action. The declaratory and injunctive relief sought is relevant to the situation of persons and property in this district.
PROCEDURAL BACKGROUND OF THIS CASE
11. PRN initially filed, on January 14, 2008, a verified petition in the Eighteenth Judicial District, District Court, Sedgwick County, Kansas (case no. O8CV0183), seeking a TRO to prevent KASBHA from suspending or revoking Dr. Stephen Schneider’s medical license on an “emergency basis” in a summary process before an ALJ. PRN’s motion for a TRO was denied because the Court refused to hear the TRO without the KASBHA being present, a hearing date was set on the resulting motion for preliminary injunction, and KASBHA filed a Motion to Dismiss. PRN subsequently filed a motion for appointment of a special master, and two third parties filed to intervene. In consultation with KASBHA’s counsel, an agreement was reached that all motions would be heard on February 15, 2008. Thus, PRN understood that KASBHA had acceded to a legitimate judicial process and that KASBHA would, accordingly, withdraw its motion before the ALJ to suspend Dr. Schneider’s license, thus maintaining the status quo (i.e., with the Schneider licensure in place) until the Kansas State court would hear all the motions. [See Declaration of Uzo Ohaebosim, filed herewith.] Instead, KASBHA failed to withdraw its motion before the ALJ, and the ALJ suspended his license on the theory that, though incarcerated, he presented a danger to the public health. Thus, KASBHA accomplished its ends by subverting the legitimate judicial process that was proceeding in Kansas State court. In response, on February 1, 2008, Plaintiff’s counsel, accompanied by one of Dr. Schneider’s patients, presented a motion for a second TRO, requesting the Kansas State court to order the suspension of Dr. Schneider’s license stayed. Even under these circumstances – when the danger to patients was no longer merely threatened but was clear and present – the Kansas court refused even to hear the motion without the KASBHA being present.
THE MEANING OF A TRO AND THE EFFECT OF ITS ABSENCE
12. In their analysis of Section 60-903 (2007) of the Kansas Code Of Civil Procedure, an analysis found in 5 Kan. Law & Prac., Code Of Civ. Proc. Anno. § 60-903 (2007), the Late Hon. Spencer A. Gard2 and Robert C. Casad3 explicate the meaning and effect of a temporary restraining order as follows (with emphasis added):
The issuance of a temporary restraining order is a matter for the sound discretion of the court. It is ordinarily done ex parte, without notice to the party affected, and for this reason will be conservatively and reluctantly granted. The justification for it is that the lapse of time required for notice and hearing, or the very fact that it is being sought, may result in the impending wrong being accomplished, after which an injunction is an idle gesture.
13. Presumably, all judges in Kansas State courts are fully apprised of the purpose and effect of TROs. Despite the Courts knowledge of the grievous harm done to Schneider Clinic patients and of plaintiff’s contention that fundamental rights, protected by the U.S. Constitution, were being violated (see Exhibit A, Verified Petition), the Kansas court refused to hear the matter ex parte putting at least a temporary end to that harm. The Court’s refusal to hear the motion ex parte typifies the systemic and shocking failure of Kansas officials to recognize the humanity and citizenship of these patients.
KANSAS HAD BEEN PUT ON NOTICE
14. Both the Kansas district court and, especially, the KASBHA had notice that Dr. Schneider’s medically vulnerable patients were in immediate mortal danger. KASBHA, supposedly replete with medical expertise, and the Kansas district court by failing to hear the ex parte TRO motions, ignored the danger to some 1000 patients, thus bringing on a public health disaster. Significant damage has already been done: patients lives have been and are being put at risk by the unconscionable behavior of KASBHA.
THE ROLE OF THE KASBHA UNDER DRUG PROHIBITION
15. To prevent diversion of controlled substances with medical uses, the CSA regulates the activity of physicians. To issue lawful prescriptions of Schedule II drugs, physicians must “obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him.” 21 U.S.C. § 822(a)(2). The Attorney General may deny, suspend, or revoke this registration if the physician's registration would be “inconsistent with the public interest.” § 824(a)(4); § 822(a)(2). When deciding whether a practitioner's registration is in the public interest, the Attorney General “shall” consider (inter alia): “(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.” §823(f). However, in Gonzales v. Oregon, 546 U.S. 243, 245, 126 S.Ct. 904, 909, 163 L.Ed.2d 748 (2006), the U.S. Supreme Court declared that
[It] would be anomalous for Congress to have painstakingly described the Attorney General's limited authority to deregister a single physician or schedule a single drug, but to have given him, just by implication, authority to declare an entire class of activity outside the course of professional practice and therefore a criminal violation of the CSA.
16. Prior to the time the USDoJ indicted Dr. Schneider on violations of the CSA and related offenses, the KASBHA had refrained from taking action against the doctor’s license at the request of assistant U.S. attorney Treadway until after her office had brought federal criminal charges. It was only after the fact, and in what appears to be an attempt to rewrite history, that the KASBHA moved to suspend Dr. Schneider’s license. As a direct result of the revocation of Dr. Schneider’s license, the Schneider clinic has been closed and over 1000 patients have been forcibly abandoned and now must fend for themselves. In short, KASBHA’s actions violated and continue to do irreparable harm to these patients’ rights guaranteed under the fifth, fourteenth, and eighth amendments to the U.S. Constitution, and KASBHA’s actions also run afoul of the Americans with Disabilities Act.
CHRONIC, SEVERE PAIN IS A SERIOUS MEDICAL CONDITION
17. Because of the inflammatory and systematic disinformation campaign undertaken by the U.S. Department of Justice and the Drug Enforcement Administration on the subject of the medically responsible use of opioids in the treatment of severe and/or chronic pain, Plaintiff believes it necessary to offer a brief review of genuine, relevant, scientific findings to the Court’s attention – findings which entirely contradict the widespread public perception that chronic pain patients treated with opioids are drug addicts and give the lie to claimed necessity to hound physicians who treat such patients. Tragically, even the general medical culture identifies pain patients as “drug addicts”, although specialists in pain care distinguish addiction from dependency. The situation of patients in pain is akin to that of diabetics: the former need pain medication, and opioids in particular; the latter need insulin; both are dependent on appropriate medicines to maintain their health and to lead normal lives.
18. “Pain is a more terrible lord of mankind than even death itself.”4 Pain can be debilitating.5 Persistent pain can destroy the quality of life and the will to live.6 The source of any given pain determines neither its magnitude, nor the degree to which the sufferer is debilitated.
19. During the past two decades, there has been a revolution in the scientific and medical understanding of pain and its proper treatment. Physicians have come to appreciate that more than merely an unpleasant side effect of injury or disease, which can or should be endured, pain is a significant cause of other morbidity, including progressive brain damage.7 Indeed, pain per se is a malignancy in the sense that when it goes untreated it tends to increase in intensity, and to spread to areas of the body that were not previously affected. In doing so, it inflicts progressive damage upon the sufferer’s health and functioning. This spread occurs through physiological processes recognized as central sensitization and neuroplasticity. These processes adversely alter the chemical and anatomical makeup of the areas of the spinal cord and brain that modulate the transmission of pain signals.8 Ongoing pain is the single condition prerequisite to the development of the disease state of chronic pain. As a result, the term “pain” is used to identify both the disease vector, and the illness.
20. Modern medicine has the ability to relieve or reduce suffering caused by nearly all types of pain.9 Nevertheless, the under-treatment of pain is a serious and widespread health issue.10 A lack of public understanding about the nature of pain therapy and overbearing actions of regulatory authorities have combined to impede access to pain treatment, deter physicians from practicing pain medicine,11 chill the legitimate prescription practices of physicians who do treat pain,12 and thereby deny patients in this country their constitutionally protected right to relief from unnecessary suffering.13
21. The attitudes that deter the use of opioid analgesics to treat pain stem from the mistaken beliefs of the addictive potential of opioids and our nation’s commitment to eradicate drug addiction at all costs. While addiction is a hazard in the field of pain medication, it is important to differentiate between opioid addiction, dependence, and tolerance in order better to understand how trained physicians can provide effective treatment for pain, while minimizing the risks that attend opioid therapy. The following definitions are based on consensus guidelines agreed upon by major pain and addiction organizations.
ADDICTION, DEPENDENCE, and TOLERANCE
22. Addiction. The American Society of Addiction Medicine defines addiction as a psychological syndrome characterized by continued use of a drug in spite of harm. The pain management physician employs functional criteria to monitor the course of chronic opioid therapy, regularly assessing pharmacological efficacy (analgesia), side effects, as well as physical, cognitive, emotional, and behavioral/social functioning, and well being. The patient who meets expectations in these areas is presumed to be a chronic pain patient rather than an addict. If opioid analgesics appear to make life worse for a patient, the possibility of addiction should be included in the differential diagnosis of possible causes for the observed deterioration. Pain sufferers titrated with opioids to good analgesic effect, generally enjoy improved quality of life, and stable or improved ability to perform daily activities.14 In lay usage, the term addiction, carries many value-laden connotations. Addiction, as the term is used in society in general, and in courtrooms specifically, describes a form of demonic possession: the drug’s “victims” are portrayed as having been taken over by inanimate substances carrying the power to render individuals unable to access their own will power.15
23. Dependence. Dependence is a physical phenomenon, not a sign of addiction. If opioids are abruptly discontinued, a physical withdrawal reaction will occur. This reaction resembles a moderate to severe case of the flu. If opioid analgesics need to be discontinued, this withdrawal reaction can be prevented by gradually tapering, slowly lowering the dose over time. The following is the position of major pain and addiction organizations with regard to the phenomenon of dependence.
Physical dependence on and tolerance to prescribed drugs do not constitute sufficient evidence of psychoactive substance use disorder or addiction. They are normal responses that often occur with the persistent use of certain medications. Physical dependence may develop with chronic use of many classes of medications. These include beta-blockers, alpha-2 adrenergic agents, corticosteroids, antidepressants, and other medications that are not associated with addictive disorders.16
24. Tolerance. When opioids are used on a regular schedule, tolerance to nausea, respiratory depression, and intoxication develops quickly, while tolerance to analgesia develops slowly if at all. A patient on a chronic, stable daily dosage of opioids experiences no intoxication, no euphoria, and no sensory or motor impairment. Patients look, feel, and behave normally. This is confirmed by the observation that the ability to drive an automobile is not impaired in patients following stable medication regimens.17
MISPERCEPTIONS REGARDING WITHDRAWAL
25. The perception common to the general public as well as to the vast majority of the medical community is that withdrawal never killed anyone. Pain specialists know that that perception is false. Patients in pain, whose lives have already been impacted by some serious physical problem, are especially medically vulnerable.18
26. Leaders in the medical community may profess an understanding of the effects of withdrawal on pain patients, but, in practice, physicians’ behavior toward pain patients is dangerous and prejudicial to their rights and health. When these patients are out of pain medication, they need to find help immediately in order to prevent both their entry into the dangerous situation of withdrawal and the return of their intolerable pain. Failing to obtain needed medication may lead to suicide. However, ER physicians take it upon themselves to make a determination – which cannot but be subjective – as to whether a presenting pain patient is either “deceptive” or “dependent” – and then to refuse to provide medically vital treatment to the former.
27. Worse: pain patients in withdrawal are faced with physicians who follow the standard decision-making paradigm of “differential diagnosis”, a procedure which supposedly concentrates on the three or four most likely causes of symptoms presented by such patients, but who, when faced with patients in pain, refuse to recognize withdrawal and to stabilize those patients by prescribing opioids. That is, those physicians claim to take appropriate action, but will diagnose anything but withdrawal; they employ “drug control” rather then stabilizing the patients, so that the “good” of removing patients from their “addiction” to opioids is accomplished at all costs to the patients’ health.
28. Most of Dr. Schneider’s patients are refusing to go to ERs because of their prior experience of being “treated” with contempt and rudeness, as if they were subhuman creatures.
29. For all these reasons, PRN is asking this Court to intervene to mitigate damage already done and to protect the clinic facility now being opened under the auspices of another licensed physician so that patients in pain have somewhere to turn for appropriate care.
KANSAS’ OFFICIAL ACKNOWLEDGMENT OF THE NECESSITY OF TREATMENT OF CHRONIC PAIN - AND OF THE ABSENCE OF SUCH TREATMENT
30. In a recent article about Kansas’ adoption of State Medical Board Guidelines, two leading Kansas academics addressed the need for treatment of chronic pain as follows:
Similar to states across the nation, pain management is a serious problem in Kansas. In 2000, data was collected by the Kansas Department of Health and Environment through the Behavior Risk Factor Surveillance Survey, revealing that 86 percent of Kansans experience moderate to excruciating pain during the last few months of life. Forty-five percent of Kansans in long-term facilities experience persistent pain. Chronic pain patients are not always able to find physicians or access health care systems. Costs of medications prevent some Kansans from taking medications as prescribed. Myths, fears and misconceptions about pain medications prevent excellence in pain management.19 (Emphasis added)
31. When these Guidelines were adopted back in 2002, it was not widely known that Federal criminal prosecutions of licensed physicians were responsible for depriving Kansans, and all Americans, of care. So when the Board of Healing Arts, along with the Nursing and Pharmacy boards did not perceive its conflict of interest with the United States Department of Justice, Kansas became the first state in the nation to adopt the following
Joint policy statement:
Joint Policy Statement of the Kansas Boards of Healing Arts, Nursing and Pharmacy on the Use of Controlled Substances for the Treatment of Pain
Source: Living Initiatives For End-Of-Life Care, The Kansas LIFE Project
Statements adopted by:
Kansas Board of Healing Arts, June 1, 2002
Kansas Board of Nursing, July 17, 2002
Kansas Board of Pharmacy, June 10, 2002
Section I: Preamble
The Kansas Legislature created the Board of Healing Arts, the Board of Nursing, and the Board of Pharmacy to protect the public health, safety and welfare. Protection of the public necessitates reasonable regulation of health care providers who order, administer, or dispense drugs. The boards adopt this statement to help assure health care providers and patients and their families that it is the policy of this state to encourage competent comprehensive care for the treatment of pain. Guidelines by individual boards are appropriate to address issues related to particular professions.
The appropriate application of current knowledge and treatment modalities improves the quality of life for those patients who suffer from pain, and reduces the morbidity and costs associated with pain that is inappropriately treated. All health care providers who treat patients in pain, whether acute or chronic, and whether as a result of terminal illness or non-life-threatening injury or disease, should become knowledgeable about effective methods of pain treatment. The management of pain should include the use of both pharmacologic and non-pharmacologic modalities.
Inappropriate treatment of pain is a serious problem in the United States. Inappropriate treatment of pain includes non-treatment, undertreatment, overtreatment, and ineffective treatment. All persons who are experiencing pain should expect the appropriate assessment and management of pain while retaining the right to refuse treatment. A person's report of pain is the optimal standard upon which all pain management interventions are based. The goal of pain management is to reduce the individual's pain to the lowest level possible, while simultaneously increasing the individual's level of functioning to the greatest extent possible. The exact nature of these goals is determined jointly by the patient and the health care provider."
The entirety of the Joint Policy Statement is attached as Exhibit B.
POLITICAL PRESSURES BROUGHT TO BEAR ON PATIENTS IN CHRONIC, SEVERE PAIN
32. In brazen contravention of the principles enunciated in the Guidelines, the Drug Enforcement Administration and the United States Department of Justice have embarked on a deadly and unlawful campaign against pain-treating physicians, a campaign denounced by a majority of states' attorneys general in a letter signed on to by the former Kansas Attorney General himself, Phill Kline. See Exhibit C, Letter from the National Association of Attorneys General to Karen P. Tandy, DEA Administrator, of January 19, 2005.
33. Exhibit D, “Treating Doctors as Drug Dealers: The DEA’s War on Prescription Painkillers”, by Ronald. T. Libby, provides a in-depth analysis of the reasons why millions of Americans are unable to obtain treatment of chronic, often life-threatening pain.
34. Exhibit E, Testimony of PRN President Siobhan Reynolds before the House Subcommittee on the Judiciary in the July 12, 2007, hearing aptly named “The DEA’s Regulation of Medicine” provides a general, up-to-date overview of what has actually occurred as a result of the divergence between state and Federal policies as concerns pain treating physicians.
35. The USDoJ has terrorized physicians and pain patients throughout the country, securing huge sentences (up to 30 years in federal prison). Through the in terrorem effect of its extralegal actions, the USDoJ has come close to succeeding in its unconstitutional practice of shutting down effective pain treatment throughout the United States.
36. The CSA ostensibly provided a safe harbor for the treatment of pain, and the DEA was charged not only with drug control but also with securing an adequate supply of opioids for pain patients. Neither provision has proven to be operative.
THERE IS A FUNDAMENTAL RIGHT TO RELIEF FROM SEVERE PAIN THROUGH EFFECTIVE MEDICAL TREATMENT
IN THE FORM OF FDA-APPROVED PHARMACEUTICALS
37. It has long been assumed in all civilized societies that no human being should suffer pain unnecessarily, but it is only recently courts in the United States have addressed issues attendant to that assumption. Thus, in Washington v. Glucksberg, 521 U.S. 702, 117 S.Ct. 2258, 138 L.Ed.2d 772 (1997) and Vacco v. Quill, 117 S.Ct. 2293 (1997), the U.S. Supreme Court unanimously ruled that there is no constitutional right to physician-assisted suicide. However, a Court majority effectively required all states to ensure that their laws do not obstruct the provision of adequate palliative care for the alleviation of pain. It was never contemplated by the Court that the federal government would so grossly interfere with the practice of medicine in the States. In Vacco, three Justices (O’Connor, Ginsburg, and Breyer) specifically concluded that judicial intervention would become necessary, as Justice Breyer put it, “were state law to prevent the provision of palliative care…” Vacco, 117 S.Ct. at 2312. Justice O’Connor, in her brief concurring opinion, went so far as to say that “[t]here is no dispute that dying patients … can obtain palliative care, even when doing so would hasten their deaths.” Vacco, 117 S.Ct. at 2303. An additional two Justices (Souter and Stevens) mentioned this issue as one among other problems afflicting terminally ill people that, if not adequately addressed by state legislatures, would require future judicial intervention. Glucksberg, 117 S.Ct. at 2290 (Souter); Vacco, 117 S.Ct. at 2308 (Stevens). Putting these opinions together demonstrates conclusively that there is a fundamental right to palliative care, provided that such care does not use pharmaceuticals not approved by the FDA. See Abigail Alliance v. Eschenbach, 495 F.3d 695 (D.C.Cir. 2007). Thus, the Supreme Court has given legal recognition to a previously unarticulated fundamental right.
LEGAL REQUIREMENTS FOR A TEMPORARY RESTRAINING ORDER
38. Federal Rule of Civil Procedure 65 provides that a court may issue a temporary restraining order provided that
(1) it clearly appears from specific facts shown by affidavit or by the verified complaint that immediate and irreparable injury, loss, or damage will result to the applicant before the adverse party or that party’s attorney can be heard in opposition, and (2) the applicant’s attorney certifies to the court in writing the efforts, if any, which have been made to give the notice and the reasons supporting the claim that notice should not be required.
As this is a certified complaint, and as the certification appended states that notice has been given to attorneys for the USDoJ and for KASBHA, this Court may issue a TRO as requested.
The status quo
39. The purpose of a preliminary injunction is to preserve the status quo, or to prevent irreparable injury, pending a final determination on the merits. University of Tex. V. Camenisch, 451 U.S. 390, 395, 101 S.Ct. 1830, 68 L.Ed.2d 175 (1981); Chalk v. U.S. Dist. Court Cent. Dist. of California, 840 F.2d 701, 704 (9th Cir. 1988). The status quo is the last uncontested status that preceded the pending controversy. Tanner Motor Livery, Ltd. v. Avis, Inc. 316 F.2d 804, 809 (9th Cir. 1963). Here, the uncontested status is the existence of Dr. Schneider’s license to practice medicine and to prescribe controlled substances, particularly for chronic pain patients.
The balancing test
40. To obtain a preliminary injunction, plaintiffs must show either (1) a combination of probable success on the merits and the possibility of irreparable injury, or (2) that serious questions are raised and the balance of hardships tips sharply in their favor. Id. These are not separate tests, but the outer reaches of “a single continuum”. Dominion Video Satellite, Inc. v. Echostar Satelite Corp., 356 F.3d 1256, 1260 (10th Cir. 2004); Los Angeles Memorial Coliseum Com’n v. National Football League, 634 F.2d 1197, 1201 (9th Cir. 1980); Harper v. Farm Credit Admin. 628 F.Supp. 1030 (D.Or. 1985) (Panner, C.J.).
In the typical case, as this case, where the injunction sought is merely prohibitory – i.e., requiring the non-movant to stop acting in a manner that disturbs the status quo – a movant may be entitled to a lesser standard of proof on the likelihood-of-success-on-the-merits factor if it satisfies the first three of the Lundgrin requirements. See Walmer v. United States Dep’t of Defense, 52 F.3d 851, 854 (10th Cir. 1995). Under those circumstances, the movant may establish the final factor simply by raising questions “so serious, substantial, difficult and doubtful as to make the issues ripe for litigation and deserving of more deliberative investigation.” Id.
41. Serious questions are those sufficient to warrant further consideration by the court and to present fair grounds for litigation. See Gilder v. PGA Tour, Inc., 936 F.2d 417, 422 (9th Cir. 1991). If the balance of hardships tips decidedly toward the plaintiffs, less likelihood of success on the merits is required. Wilson v. Watt, 703 F.3d 395, 399 (9th Cir. 1983). Certainty, or even the probability, of success is not required, but the plaintiffs must still demonstrate at least “some chance of success on the merits.” Id. Cf. Gilder, 936 F.2d at 422 (a “fair chance” of success). The district court must also consider the public interest, in applicable. American Motorcyclist Association v. Watt, 714 F.2d 962, 965 (9th Cir. 1983).
PLAINTIFF MEETS THE LEGAL REQUIREMENTS
42. Dr. Schneider has successfully treated chronic patients for many years. Even if, as the USDoJ alleges, some vanishingly small percentage of the controlled substances he has prescribed to chronic pain patients has found its way into illicit use, there is no evidence whatever that he should be held responsible for any actions resulting in such use. Furthermore, the affidavits attached hereto show conclusively that the revocation of his license by KASBHA would be almost certain to visit irreparable injury on his chronic pain patients. Serious questions are raised simply by the fact that Dr. Schneider is unavailable to present his side of the story to KASBHA. The balance of hardships tilts substantially in favor of the patients, as there is no public interest in depriving chronic pain patients of the possibility of obtaining appropriate medication and great public interest in seeing that they may do so.
CONCLUSION
43. In sum, PRN is asking the Court to restore the status quo that obtained before the ALJ’s decision – by issuing orders to the KASBHA to restore Dr. Schneider’s license, to the USDoJ to refrain from harassing the new clinic to be opened in the Schneider facility (under the auspices of Dr. Sack, who holds a valid license from the KASBHA), and to appoint a special master to oversee the clinic’s financial operations so as to protect it from charges of “money laundering”. PRN will soon be filing a constitutional challenge to the CSA. At the moment, however, PRN is seeking only a TRO to remedy the emergency outlined herein.
WHEREFORE, Plaintiff Pain Relief Network respectfully requests the following relief:
(1) that, in accordance with the U.S. Supreme Court’s holdings in Glucksberg and Vacco, the Court declare that there is a fundamental right to relieve severe pain through effective medical treatment in the form of FDA-approved pharmaceuticals;
(2) that the Court order the State of Kansas, through its agency, the Kansas State Board of Healing Arts (KASBHA), to reinstate Dr. Stephen J. Schneider's medical license, suspended in an ex parte hearing before an administrative law judge (ALJ) without due process, until such time as Dr. Schneider’s federal case (no. 07-10234-WEB, in the U.S. District Court for the District of Kansas, Wichita Docket) is adjudicated – such an order allowing the Schneider clinic to remain open under Kansas law;
(3) that the Court order the State of Kansas, through its agency, the KASBHA, to affirm that it has no objection to Dr. Joseph M. Sack’s taking over the operation and management of the Schneider Clinic until such time as said federal case is adjudicated;
(4) that the Court appoint a special master to oversee the reopened clinic’s financial operations so as to protect it from charges of “money laundering”;
(5) that the Court enjoin the U.S. Department of Justice (USDoJ) from taking further harassing actions against said clinic in its operation under the direction of Dr. Joseph M. Sack (who holds a valid license from the KASBHA), said actions to include, but not be limited to, confiscation of patient files and any other actions that impede the clinic’s operations and its treatment of patients in severe pain;
(6) that the Court enjoin the USDoJ to return to the reopened clinic the entirety of the originals of all patient files in the Schneider clinic that were confiscated, in whole or in part, in violation of federal law;
(7) that the Court award Plaintiff the costs of this action and attorney fees; and
(8) that the Court award such other relief as it finds just and equitable.
DATED this _____ day of February, 2008.
Respectfully Submitted,
The Law Offices of Uzo L. Ohaebosim
_s/Uzo L. Ohaebosim__________________
Uzo L. Ohaebosim
510 N. Main
Wichita, KS. 67214
Phone: (316) 261-5400
Fax: (316) 261-5404
//
//
CERTIFICATE OF SERVICE
I hereby certify that on February 13, 2008, copies of this document have been delivered by facsimile transmission to Mark Stafford, General Counsel, Kansas State Board of Healing Arts, to Michael Mukasey, Attorney General, U.S. Department of Justice, and to Eric F. Melgren, U.S. Attorney, U.S. Department of Justice.
s/Uzo L. Ohaebosim____________
Uzo L. Ohaebosim
APPENDIX I:
BACKGROUND OF THE CONTROLLED SUBSTANCES ACT
A.1. Shortly after taking office in 1969, President Nixon declared a national “war on drugs.”20 As the first campaign of that war, Congress set out to enact legislation that would consolidate various drug laws on the books into a comprehensive statute, provide meaningful regulation over legitimate sources of drugs to prevent diversion into illegal channels, and strengthen law enforcement tools against the traffic in illicit drugs.21 That effort culminated in the passage of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 84 Stat. 1236.
A.2. This was not, however, Congress' first attempt to regulate the national market in drugs. Rather, as early as 1906 Congress enacted federal legislation imposing labeling regulations on medications and prohibiting the manufacture or shipment of any adulterated or misbranded drug traveling in interstate commerce.22 Aside from these labeling restrictions, most domestic drug regulations prior to 1970 generally came in the guise of revenue laws, with the Department of the Treasury serving as the Federal Government's primary enforcer.23 For example, the primary drug control law, before being repealed by the passage of the CSA, was the Harrison Narcotics Act of 1914, 38 Stat. 785 (repealed 1970). The Harrison Act sought to exert control over the possession and sale of narcotics, specifically cocaine and opiates, by requiring producers, distributors, and purchasers to register with the Federal Government, by assessing taxes against parties so registered, and by regulating the issuance of prescriptions.24
A.3. Then in 1970, after declaration of the national “war on drugs,” federal drug policy underwent a significant transformation. A number of noteworthy events precipitated this policy shift. First, in Leary v. United States, 395 U.S. 6, 89 S.Ct. 1532, 23 L.Ed.2d 57 (1969), the U.S. Supreme Court held certain provisions of the Marihuana Tax Act and other narcotics legislation unconstitutional. Second, at the end of his term, President Johnson fundamentally reorganized the federal drug control agencies. The Bureau of Narcotics, then housed in the Department of Treasury, merged with the Bureau of Drug Abuse Control, then housed in the Department of Health, Education, and Welfare (HEW), to create the Bureau of Narcotics and Dangerous Drugs, currently housed in the Department of Justice.25 Finally, prompted by a perceived need to consolidate the growing number of piecemeal drug laws and to enhance federal drug enforcement powers, Congress enacted the Comprehensive Drug Abuse Prevention and Control Act.26
A.4. Title II of that Act, the CSA, repealed most of the earlier antidrug laws in favor of a comprehensive regime to combat the international and interstate traffic in illicit drugs. The main objectives of the CSA were to conquer drug abuse and to control the legitimate and illegitimate
traffic in controlled substances.27 Congress was particularly concerned with the need to prevent the diversion of drugs from legitimate to illicit channels.28
A.5. To effectuate these goals, Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA. 21 U.S.C. §§ 841(a)(1), 844(a). The CSA categorizes all controlled substances into five schåedules. § 812. The drugs are grouped together based on their accepted medical uses, the potential for abuse, and their psychological and physical effects on the body. §§ 811, 812. Each schedule is associated with a distinct set of controls regarding the manufacture, distribution, and use of the substances listed therein. §§ 821-830.
A.6. Schedule I drugs are categorized as such because of their high potential for abuse, lack of any accepted medical use, and absence of any accepted safety for use in medically supervised treatment. § 812(b)(1). These three factors, in varying gradations, are also used to categorize drugs in the other four schedules. For example, Schedule II substances also have a high potential for abuse which may lead to severe psychological or physical dependence, but unlike Schedule I drugs, they have a currently accepted medical use. § 812(b)(2).
Congress classified a host of substances when it enacted the CSA, but the statute permits the Attorney General to add, remove, or reschedule substances. He may do so, however, only after making particular findings, and on scientific and medical matters he is required to accept the findings of the Secretary of Health and Human Services (Secretary). These proceedings must be on the record after an opportunity for comment. See 21 U.S.C.A. § 811 (main ed. and Supp.2005).
Gonzales v. Oregon, 546 U.S. 243, 250, 126 S.Ct. 904, 911-122, 163 L.Ed.2d 748 (2006) (emphasis added).
A.7. The CSA and its implementing regulations set forth strict requirements regarding registration, labeling and packaging, production quotas, drug security, and recordkeeping. Ibid. 21 CFR § 1301 et seq. (2004). The Attorney General or his designee, the DEA, administers the registration scheme. Under certain limited circumstances, the DEA may deny or revoke a physician’s or pharmacist’s DEA registration and, with it, the right to prescribe or dispense controlled substances. 21 U.S.C. §§ 823-24. Any person distributing a controlled substance, except as authorized by the CSA, is subject to severe criminal penalties. 21 U.S.C. §§ 841-846.
A.8. Giving effect to the CSA is 21 CFR § 1306.04(a); in pertinent part, it provides:
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. …. An order purporting to be a prescription issued not in the usual course of professional treatment … is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. [Emphasis added.]
A.9. Traditionally, the determination of what constitutes a legitimate medical purpose has been left to the States. Indeed, in the words of the U.S. Supreme Court, “[t]he CSA explicitly contemplates a role for the States in regulating controlled substances, as evidenced by its pre-emption provision.
No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates … to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision … and that State law so that the two cannot consistently stand together.” § 903.
Gonzales v. Oregon, 546 U.S. at 251, 126 S.Ct. at 912.
