PRN v Kansas, Mukasey, DOJ, et al.

• (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.

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.

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.

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.

[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.

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.

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

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.

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.

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.

(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).

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:

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.

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