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REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
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MISINTERPRETATION OF CDC GUIDELINES RESULTING IN HARM
The Case: No. 20-237 WES, Edith Fuog vs. CVS Pharmacy, INC., et al. from the record it reads MEMORANDUM AND ORDER
WILLIAM E. SMITH, District Judge:
Edith Fuog, suffers from a long list of serious medical conditions, many of which stem from her 2011 breast cancer diagnosis and subsequent MRSA1 infection. Second Amend. No one disputes that Ms. Fuog is disabled, nor that her life involves a constant struggle with chronic pain, for which her doctors have prescribed her opioids. Rather, in this case, the parties spar over the cause and legality of an additional struggle faced by Ms. Fuog: filling her opioid prescriptions at CVS pharmacies.
More specifically, Ms. Fuog alleges in this putative class action that two business segments of non-party CVS Health Corporation, Defendants CVS Pharmacy, Inc. and Caremark PHC, L.L.C. (“CVS Caremark” collectively, “CVS”), have misinterpreted guidance from the Center for Disease Control (“CDC”) by instituting formal and informal polices which discourage or prohibit its pharmacists from filling opioid prescriptions above a certain dose and duration threshold. Id. ¶ 46. She contends this constitutes unlawful discrimination against the disabled in violation of Title III of the Americans with Disabilities Act (“ADA”), 42 U.S.C. § 12182(a) (Count I); Section 504 of the Rehabilitation Act, 29 U.S.C. § 794(a) (Count II); and the anti-discrimination provisions of the Affordable Care Act (“ACA”), 42 U.S.C. § 18116(a).
BACKGROUND
Before the Court is Defendants’ Motion to Dismiss Plaintiff’s Second Amended Class Action Complaint, ECF No. 42. For the reasons that follow, that Motion is GRANTED in part, and DENIED in part.
This case arises against the backdrop of the opioid epidemic and the torrent of litigation it spawned. See id. Ms. Fuog alleges that when CVS was sued more than 2,000 times for allegedly dispensing too many opioids too freely, it overcorrected by implementing policies that unfairly and illegally prevent its pharmacists from filling opioid prescriptions for a class of disabled chronic pain sufferers who need them. Id.
She claims that these policies are based on a fundamental misinterpretation of the CDC Guideline for Prescribing Opioids for Chronic Pain, issued in 2016.
THE GUIDELINE HAVE HARMED MANY PAIN PATIENTS NEW FURTHER UNDERMINE PATIENT PAIN CARE
This Guideline is virtually identical to the 2016 version and focuses extensively on reducing and eliminating the legitimate use of opioids for pain management which has harmed many pain patients who have been abruptly forced off medication they use appropriately and rely on to function.
Yet the Guideline remains silent on what patients living with high-impact, relentless, severe pain should do for pain management beyond recommending non-opioid therapies, many of which have significant access barriers.
Of central concern is that the entire conceptual framework of this fatally flawed document is centered on restrictions of Morphine Milligram Equivalent Dose — a concept that is long known to be actively harmful junk science.
The American Medical Association (AMA) June 2019 writes:
“The nation no longer has a prescription opioid-driven epidemic. However, we are now facing an unprecedented, multi-factorial, and much more dangerous overdose and the drug epidemic is driven by heroin and illicitly manufactured fentanyl, fentanyl analogs, and stimulants. We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens. This is why the AMA continues its aggressive advocacy efforts in support of patients with pain and those with a substance use disorder as well as broad support for harm reduction policies and practices that address the wide range of factors affecting patients. “
The nation’s opioid epidemic has never been just about prescription opioids, and we encourage CDC to take a broader view of how to help ensure patients have access to evidence-based comprehensive care that includes multidisciplinary, multimodal pain care options as well as efforts to remove the stigma that patients with pain experience on a regular basis. CDC has a great opportunity to demonstrate its commitment to patients with pain through a detailed re-examination of the CDC Guideline, and the AMA urges CDC to work with physicians and patients to ensure that the revisions support patients with pain and the physicians who care for them.”
FEDERAL LAW ENFORCEMENT AGENCIES ARE UNQUALIFIED TO DETERMINE WHETHER DRUGS “HAVE A USEFUL AND LEGITIMATE MEDICAL PURPOSE
The Supreme Court has long recognized that the state’s protection of “the health of its citizens . . . is at the core of its police power,” Sporhase v. Neb. ex rel. Douglas, 458 U.S. 941, 956 (1982), and has expressly rejected the notion that the CSA grants either DOJ or DEA the broad authority to regulate the practice of medicine:
[t]he [CSA] and our case law amply support the conclusion that Congress regulates medi- cal practice insofar as it bars doctors from us- ing their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood. Beyond this, however, the statute manifests no intent to regulate the practice of medicine generally. The silence is understandable given the structure and limitations of federalism, which allow the [s]tates “[ ]great latitude un- der their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons. [ ]” Gonzales, 546 U.S. at 269-70 (emphases added).
Not only does Congress know how to explicitly delegate the authority to regulate controlled substance prescribing to a federal agency, it has done so in one— and only one—narrow category: opioid use disorder (OUD) treatment. Id. at 271 (holding that 42 U.S.C. § 290bb-2a is the only arena in which Congress has set federal medical standards and “indicates that when Congress wants to regulate medical practice in the given scheme, it does so by explicit language in the statute”); see also Anderson et al. at 98 (“Despite the longstanding norm of federal noninterference in medicine, . . . the federal government can regulate medical practice if it makes its intention to do so clear and un- ambiguous.”).
And even then, Congress expressly delegated the authority to set federal medical standards regarding OUD treatment to the Department of Health and Human Services (HHS) and not a federal law enforcement agency. 42 U.S.C. § 290bb-2a (“The Secretary of Health and Human Services, after consultation with the Attorney General . . . shall determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction. . . .”).
Federal law enforcement agencies are unqualified to determine whether drugs “have a useful and legiti- mate medical purpose and are necessary to maintain the health and general welfare of the American people.”
21 U.S.C. § 801(1). Congress, therefore, did not even leave it to DEA to perform one of its core CSA functions—the scheduling of controlled substances— without health care agency oversight and evaluation. See id. § 811(b) (“The Attorney General shall, before in- itiating proceedings . . . [to schedule or reschedule a drug] . . . request from the [HHS] Secretary a scientific and medical evaluation, . . . The recommendations of the Secretary to the Attorney General shall be binding . . . as to such scientific and medical matters.”).
Furthermore, this Court has expressly held that DOJ cannot criminally prosecute OUD prescribers under CSA Section 841(a)(1) unless they sell “drugs, not for legitimate purposes but ‘primarily for the profits to be derived therefrom’ ” and are acting outside the usual course of professional practice such that their behavior is akin to that of a “large-scale [drug] pusher, not as a physician.” Moore at 345.
Congress’s refusal to permit a federal agency to regulate the practice of medicine beyond illegal trafficking is further evidenced by the Narcotic Addict Treatment Act (1974) (NATA), which amended the CSA to permit HHS to regulate OUD treatment. NATA’s legislative history demonstrates that the Senate Judiciary Committee carefully weighed the states’ long- standing authority to regulate “the general practice of medicine” against
“the specialized circumstances within the purview of the bill [e.g., OUD treatment], which entail inordinate risks of di- version and unethical profiteering.” S. Rep. No. 93-192, at 13 (1973).
The Committee report further explains that the purpose of the NATA amendments was to “re- affirm the commitment Congress made to the nation when it passed the [CSA] by . . . facilitating the pros- ecution of those who engage in the criminal distribution of legitimate narcotic drugs for profit.” Id. at 15.
In sum, the CSA permits the federal prosecution of prescribers who operate as drug traffickers as tradi- tionally understood and, thereby, knowingly or intentionally engage in prescribing conduct that exceeds the bounds of professional practice. Congress never intended to delegate to law enforcement the authority to regulate the practice of medicine by criminalizing good faith medical mistakes. See 21 U.S.C. § 903.
The CSA also depends on state law to determine which medical professionals constitute “practitioners” acting “in the course of professional practice” and are, therefore, presumptively eligible for federal controlled substance registration. 21 U.S.C. § 823(f ) provides that “[t]he Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled sub- stances under the laws of the State in which he practices”) (emphasis added); id. § 802(21) (defining “practitioner” to include “a physician . . . licensed by the United States or the jurisdiction in which he practices . . . to . . . dispense . . . a controlled substance in the course of professional practice”) (emphasis added).
The CSA further mandates that DOJ defer to state medical licensing authorities before denying, suspending, or revoking a state-licensed prescriber’s registration. Id. § 823(f )(1) (explaining that the Attorney General may deny, suspend, or revoke a state-licensed prescriber’s registration if doing so is in “the public interest” and that the first of the five factors that the Attorney General must consider in making such a de- termination is “[t]he recommendation of the appropriate State licensing board or professional disciplinary authority”).
A RISING TIDE LIFTS ALL BOATS
The DEA and the drug war system in America have developed into rogue agencies that must be disbanded. These agencies have failed to recognize a peoples chronic disease conditions of intractable pain, while further failing to understand or comprehend human suffering, the science of clinical treatment and the value of human life. While the comparison may seem silly, in today’s anti-opioid climate a “one-size-fits-all” mindset has become the foundation of government-dictated medicine. And it’s very bad medicine. The deeply flawed policies that are being enacted as law all over the country are based on the “one-size-fits-none” concept of morphine milligram equivalents (MME) – the maximum amount of an opioid medication than is permitted per patient per day.
While MME values are touted as useful predictors of the total “opioid load” that a patient can receive, they are nothing of the sort. And MME-based policies don’t just fail because of differences in the size of patients; they fail for multiple reasons.
The CDC MME chart, in fact, the entire concept of morphine milligram equivalents may be convenient for bureaucrats but because of differences in the absorption of different drugs into the bloodstream, half-life of different drugs, the impact of one or more other drugs on opioid levels, and large differences of the rate of metabolism caused by genetic factors, is not only devoid of scientific utility, but actually causes far more harm than help by creating “guidelines” that are based upon a false premise. When a policy is based on deeply flawed science, the policy itself will automatically be fatally flawed. It cannot be any other way.
In today’s anti-opioid climate a “one-size-fits-all” mindset has become the foundation of government-dictated medicine. And it’s very bad medicine. The deeply flawed policies that are being enacted as law all over the country are based on the “one-size-fits-none” concept of morphine milligram equivalents (MME) – the maximum amount of an opioid medication than is permitted per patient per day.
While MME values are touted as useful predictors of the total “opioid load” that a patient can receive, they are nothing of the sort. And MME-based policies don’t just fail because of differences in the size of patients; they fail for multiple reasons.
CONCLUSION
EDITH FOUG PREVAILED AND IS A TIRELESS PAIN ADVOCATE WARRIOR
FOR NOW, YOU ARE WITHIN
THE NORMS
