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FEDERAL THIRD CIRCUIT TO HOST LANDMARK ARTIFICIAL INTELLIGENCE CRIMINAL TRIAL IN THE UNITED STATES
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“give me the man, and I will find the crime [for him]”
https://en.wikipedia.org/wiki/Give_me_the_man_and_I_will_give_you_the_case_against_him
In Poland, the saying is associated with the criticism of the justice system under totalitarian (in particular, communist) regimes.[2][18][19]: 7 [7]: 179 [10] The saying has been described as “one of the most popular, depressing and representative sayings about the general powerlessness of people faced with unjust legal systems, characteristic to all countries governed by the communists”.[19]: 7
Such abuse of power, exemplified by this saying, has been explicitly discussed in the context of military justice in the Stalinist era in Poland (1948–1956), particularly concerning the court’s ability to determine the legal classifications of the defendant’s actions, based on very vague and generic legal terminology. During that time, in several cases, the courts considered multiple competing classifications and often sided with the prosecution in defaulting to the one that would invoke the harshest punishments.[20]: 269–271
The expression is widely used in Putin-era modern Russia to describe the fabrication of criminal cases by police and judges.
Newly released documents show that the US Federal Government has allowed insurance companies and unvetted AIs to target physicians who treat pain and addiction for prosecution. As crazy as this sounds, in 2017, Attorney General Jeff Sessions became convinced that the opioid crisis was not the fault of cartels smuggling fentanyl across porous American checkpoints. And it wasn’t due to pharmaceutical companies corrupting drug approval officials and DEA administrators by hiring them as consultants after making decisions in the company’s favor. No. The opioid crisis was caused by American physicians coddling pain patients and addicts. But reviewing all the actions of tens of thousands of physicians would take literally hundreds of years and thousands of agents, so the government paid for the development of a secret weapon. It hired a private company to create a new Artificial Intelligence that would be trained to look for actions taken by physicians that the DEA deemed “illegitimate.” The theory was that artificial intelligence-enforced precrime predictive models would provide a focused criminal deterrence in the practice of medicine. There is a strong incentive in this industry to err on the side of labeling activity as illegal; indeed, “bounties” can be paid to persons and companies identifying FWA. This company’s main selling point was the use of innovative data analysis, including data mining and predictive analytics, to identify patterns and improve operational efficiencies. “Dynamic Dashboards” were created to focus on what the AI programmers perceived to be criminal behavior. AI decision-making is only as good as the data and parameters it is fed. Insurance companies told the AI that many treatments were “medically unnecessary” and, therefore, indicative of fraud. The DEA then provided its interpretation of actions it thought showed criminal medical practice, including the number of patients seen and prescriptions written per month, particularly the number of Schedule II prescriptions. The distance a patient drove, whether or not the doctor’s office accepted cash payments, and the prescribing of a “trinity” of drugs, including a narcotic with a sedative, muscle relaxer, or even, amazingly, an antibiotic. These were all seen as indicative of criminal behavior. Ignoring the fact that medical textbooks, continuing medical education (CME), and evidence-based practice say otherwise. The CDC says that treatment for pain can continue even if a patient has been diagnosed with addiction. “Although identification of an opioid use disorder can alter the expected benefits and risks of opioid therapy for pain, patients with co-occurring pain and opioid use disorder require ongoing pain management that maximizes benefits relative to risks.” The AI also uses claims, encounters, pharmacy invoices, beneficiary enrollment files, state licensing board information, property records of targeted healthcare physicians, ownership/asset and financial filings of targeted healthcare physicians, and court records, as well as other custom data in its decision-making algorithm. Chief Executive Officer Ronald G. Forsythe said, “We have combined the book smarts’ of AI and our analysts with the “street smarts” of our investigators to create one beast of a program integrity tool. Unleash the beast!” And unleash it they did, becoming, in effect, a private police force. Physicians began to see their colleague’s clinic doors kicked down and watched as these doctors were pilloried in the media for prescribing “Millions” of morphine milligram dose equivalents!” which would then be conflated with millions of pills. No matter that this was a number accumulated over several years to sometimes thousands of patients and that palliative, cancer, sickle cell, and HIV/AIDs patients had not been excluded from the numbers. Once in court, “experts” cherry-picked by the prosecutors for their extreme views made conviction easy. How can we expect randomly chosen lay people without the benefit of any medical education to sort this out? Doctors were convicted by the thousands, and tens of thousands of pain and addiction patients could not find a physician anywhere who was brave enough to treat them. These patients were at extreme risk of either killing themselves, as many did, or going to the streets to try to buy their regular pain medications. Finding instead, fake hydrocodone and oxycodone tablets were laced with fentanyl, and they died by the thousands. American citizens have the right to receive compassionate and evidence-based healthcare, and physicians have the right to treat their patients in accordance with their education, training, and experience, without being prosecuted for violating the opinions of some healthcare executive or DEA agent. No matter what the AI “beast” says.
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Timothy E. King, MD “The Rat King Mother of All Fraud” Dr. King’s assertion that prescriptions of opioids should be deemed illegitimate if there is no objective evidence of functional improvement among patients. This premise, however, fails to account for the inherently subjective nature of pain – a critical factor in assessing the effectiveness of pain management.
RED FLAG OF STUPIDITY
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What a lot of Medicare folks don’t understand, is that Medicare- C (Advantage) is provided by a for-profit insurance company, which also many own a PBM and a mail-order pharmacy. I sense at some point when Congress finally decides to attempt to balance our national budget and start working on reducing our national debt, which is now ~ 34 trillion. With Medicare-C, Congress pays a fixed $$/pt/month. Unlike traditional Medicare, where Congress has to pay for services that they are provided to Medicare folks with Traditional Medicare.
It is estimated that SS & Medicare will start having negative cash flow in the first of the next decade. I don’t see Congress just cutting everyone that is on traditional Medicare off. The last baby boomer turns 65 in 2029. I expect to see that starting in 2030, Congress will mandate that only Medicare-C will be available to new Medicare folks.
There will be dramatic changes in how healthcare is provided and the only pts who will really be happy with Medicare-C for all, will be those pts who don’t need much in the way of healthcare or costly healthcare. Attrition will take care of the number of Medicare folks on Traditional Medicare.
https://www.medpagetoday.com/special-reports/exclusives/108423
Michael Chernew, PhD, chairs the influential Medicare Payment Advisory Commission (MedPAC), an independent 17-member panel appointed by the U.S. Comptroller General to advise Congress on Medicare policy.
MedPage Today recently interviewed Chernew by phone and email about growing concerns — throughout the country and among commission members — that private Medicare Advantage plans in some ways may be failing their mission to improve access to quality care and lower costs. These plans have become the dominant way beneficiaries receive health benefits.
Chernew, who is also a health policy professor and researcher at Harvard Medical School, said he was speaking from that role.
The interview has been edited for clarity and brevity.
Cheryl Clark: Medicare Advantage plans have been enrolling beneficiaries at astonishing rates, and plans now cover 52% of eligible lives, or almost 32 million people — up from 11 million in 2010 and 33% in 2016. At this pace, 70% or 80% of eligible people will be in an MA plan in a few more years. Eventually, will everyone be required to enroll in a Medicare Advantage plan to access benefits?
Michael Chernew, PhD: For the foreseeable future, I think traditional Medicare will still be an option, but just one that fewer people choose. The pace will slow as fewer people are left to convert. But there are now markets that — in Puerto Rico for example — 92% are in Medicare Advantage plans. There are already other markets outside of Puerto Rico that are 70% and 80%.
Clark: The idea behind MA plans was to control waste, fraud, and abuse, discourage low-value services, and avoid unnecessary and potentially harmful care. But there are growing concerns that Medicare Advantage plan companies have become too big and powerful, with the profit motive often being the determining factor in whether patients get care their doctors say they need. Some have called Part C a Frankenstein. Last year, we began seeing a growing number of large physician groups and whole health systems saying they won’t take some or all of the plans because of prior authorization delays and huge losses.
Chernew: Let me broaden your question. We’ve had HMOs in Medicare since 1973. And the motivation, much as you stated, is that there’s a lot of wasteful care in the American healthcare system. Health plans have the ability to both eliminate that waste, coordinate care, and engage beneficiaries to support better health. In Medicare, private plans do provide care more efficiently, avoiding fragmentation. There’s no way to think about the whole patient in a fee-for-service system.
And what I think is increasingly important is that payments to Medicare Advantage plans get funneled in part to beneficiaries so they have more generous coverage than the traditional Medicare program, which is not a particularly generous benefit package.
Clark: Do you mean like hearing and vision coverage, transportation to the doctor, and meals? Benefits that may not have a direct medical effect?
Chernew: Right, but more basic benefits, like lower outpatient cost sharing and lower deductibles for inpatient care — the gaps in traditional Medicare.
Clark: But are you saying it’s worked out the way it’s supposed to? Your staff studyopens in a new tab or window noted that MA plans have cost the Medicare program $613 billion more than beneficiaries in fee-for-service over the last 18 years, and $353 billion of that is in just the last 5 years, $88 billion more expected in 2024 alone. These private plans have been using the risk adjustment factor to score patients 20% sicker than their counterparts in fee-for-service, which means higher capitated revenue. And some people are concerned that we really don’t know if those extra benefits — that free transportation to the doctor or that lower copay for a dental visit that some of this money is paying for — have improved health status.
Chernew: I believe the Medicare Advantage program has successfully changed patterns of care in ways that have reduced overall utilization. They have enabled plans to offer better benefits to beneficiaries, financed by the plans’ efficiencies as well as the payments they’ve received. And there’s a range of technical things — changing the risk adjustment models, which we have already done — and making changes to the quality bonus program. There’s a lot of strategies one could take if one wanted to improve the balance of payments between Medicare Advantage and fee-for-service.
Clark: The Office of Inspector General’s reports have found so much upcoding, even fraud, in many of the leading plans that have deceived the trust fund into paying more than the patients’ actual diagnoses called for. How do we stop that?
Chernew: Although there has been some documented overly aggressive coding — and in some cases I’m sure it was downright fraud — the fee-for-service coding system is imperfect too. Medicare Advantage plans will have more intense coding just because they’re more accurate.
For example, a lot of fee-for-service patients who have diabetes coded in one year might not have that reported in a subsequent year. That the MA plan is more accurate in coding is not fraudulent, but it does contribute to this imbalance between payments. I wouldn’t characterize it as malicious as your question implied. I think on average, Medicare Advantage plans probably do a good job – my guess is a better job — than fee-for-service in treating beneficiaries with chronic conditions.
Clark: Let’s shift to some of the unintended or perhaps unappreciated consequences of majority MA enrollment. Physicians at large academic hospitals that specialize in certain conditions or diseases are excluded from MA networks. Patients can’t get a consult at the Mayo Clinic in Arizona and Florida, and they can’t get cancer care at Sloan Kettering. I have friends who have had symptoms that doctors in their MA networks couldn’t diagnose, but the expert was at UC San Diego. They had to fork over $900 for an out-of-network visit. What do we say to these centers when 70% or 80% of the Medicare population can’t benefit from their expertise? I don’t think many realize that when they enroll.
Chernew: This is a complicated question. Medicare Advantage involves a trade-off. Individuals choose to have a narrow network. The challenge is for CMS to make sure people have good quality care outside of academic medical centers. It’s not the case that if you don’t go to an academic medical center, you’ll get substandard care. But it is complicated when it’s a rare diagnosis.
And academic medical centers could be in network if they negotiate with the plans. But I have a hard time seeing how one accomplishes what one wants to accomplish in the Medicare Advantage space if one requires all the academic medical centers to be in a network, or some version of that.
That said, there are some areas that merit some attention; there’s a penalty if you try to switch out of a Medicare Advantage plan because you could be underwritten in the Medigap market and it may be more expensive to get a Medigap plan.
Clark: It’s not a penalty. It’s often a rejection, right? There are 46 states that allow underwriting for supplemental plans and that usually means getting rejected for common health issues like uncontrolled diabetes or a recent hospitalization.
Chernew: I think this is going to become a growing policy issue. The problem is, if you allow people to switch back to a supplemental plan as soon as they need care, you create adverse selection. If everybody chooses the cheaper MA plan when they’re healthy, and the supplement plans when they’re sick, then the whole market collapses. In the states that prohibit underwriting, supplemental plan premiums are more expensive.
Also, the premise that the fee-for-service system has better quality and is more efficient is actually not true. It’s easy to tell stories of people in the fee-for-service system who didn’t get the care they wanted, got too much care, and were harmed in some way. Also, in Medicare Advantage there’s a lot of heterogeneity. Some plans do a better job than other plans.
Clark: Another consequence of MA plans dominating the market is that there are certain metrics, like readmissions and hospital-acquired conditions, by which we score quality of care for everybody. But those scores are drawn from care provided only to fee-for-service beneficiaries. If those scores are based on care to only a few million patients, can they still be a reliable index to score care for everybody?
Chernew: We’ll need to think about how robust those systems are for a growing MA system. Some of those measures you mention — readmissions for example — are not the best quality measures. Some other programs like MIPS (the Merit-Based Payment Incentive Program) are really lacking.
Clark: Traditional Medicare beneficiaries usually subscribe to a Part D plan, but as more beneficiaries choose Medicare Advantage plans with Part D benefits, the number of companies offering Part D plans is declining. Of course, choosing a Part D plan is impossibly confusing and seniors have to do that every year, so maybe it’s a good thing that there will be fewer Part D options?
Chernew: Of the many concerns I have about Medicare Advantage growth, the impact on the Part D market is low on my list. The other issue, how people choose the right plan, is a bigger concern. The benefits are hard to figure out and systems are hard to compare. It is hard to choose a plan. And even with MA plans with drug benefits, you have to figure out the same issues. You have to figure out the networks, what the benefits mean, and then you take a particular benefit, like dental. There’s a wide range of details.
Clark: I am well aware of the confusion and frustration. I know people who were in tears last fall trying to navigate the system after Scripps Health medical groups told 32,000 MA enrollees they weren’t contracting with any MA plans in 2024 because they were losing too much money. People I’ve known for years were devastated, and some didn’t even realize they were in an MA plan.
Chernew: When that happens, beneficiaries can choose a different MA plan. But that’s asking people to do a lot. They have to find new doctors and go through a lot of paperwork.
Clark: We’ve heard a lot about MA enrollees not being able to figure out which doctors are in network and are actually accepting new patients. Sometimes they’re listed in network but they’re on leave or their practices are full.
Chernew: That’s no doubt an issue. MA plans rely on networks to accomplish what they need to do, and on balance that’s probably a good thing but it makes choice complicated. It’s also true that an MA plan can exclude providers who might not be particularly good physicians.
The concern you raised, that when you have a bunch of competing health plans, some of them may be doing things that you would rather them not be doing, and that their beneficiaries may not be aware of, is a real concern. Is there an important role for some level of government oversight? And how do you balance that oversight with allowing the market to actually work? That will be a continuing objective of policymakers as Medicare Advantage grows, and a more important objective.
Clark: Let’s talk about misleading MA plan marketing, which CMS has tried to rein in, but there are still a lot of misleading claims.
Chernew: People are getting advice from brokers and sometimes it’s great, and sometimes not so great, sometimes given by agents who are rewarded by the plans. CMS is trying to get on top of that problem. The plans are just so complicated and so varied, there may be value in some type of standardizing benefits. It’s hard to make sure everybody gets the information they need. The broader issue you raised is that people don’t know they’re in a Medicare Advantage plan. My father wasn’t even sure.
Clark: Is he in an MA plan?
Chernew: I don’t know. I asked him and he didn’t know. He has a plan through his previous employer.
Clark: Whenever I am interviewing a senior doctor who is not employed, if the opportunity presents itself I ask if he or she has Medicare Advantage or fee-for-service. I have yet to find one in an MA plan, including many Kaiser doctors.
Chernew: I haven’t done a systematic study of that issue.
Clark: Let’s talk about delays and denials of care, prior authorization and the use of algorithms that automatically reject doctors’ requests for referrals. Sen. Richard Blumenthal (D-Conn.) said during a hearing last year that MA is “fine … so long as you don’t need it for the big stuff.”
Chernew: It is a concern and will be an ongoing tension. I remain concerned about excessive prior authorization, inadequate networks, and a whole range of things that remain major issues. There are concerns about specific plans that provide really substandard access and substandard care, and that are being overly aggressive in their claim denials. Patients are not getting the care they need and their experiences are atrocious. There are pockets of real problems. But that tends to not be what you find in a broad swath of evidence.
Clark: You may not have bodies or corpses to count. But what you do have, in my experience, listening to people who have been there, is anxiety as they waited for months for an appointment or approval. And they can’t manage the appeals process. Some people say star ratings for these plans should include a measure of their denial rates.
Chernew: Certainly understanding the rate of denials, and more importantly, what is being denied, would be valuable information. A colleague years ago was upset because his son – in a managed care plan — was in a serious accident and was discharged earlier than the father thought he should be and that he got very bad care. But he later learned that the issue was that the son was at risk of infection and getting out of the hospital to home was much safer.
Clark: Last question. How’s the solvency of the Medicare trust fund in light of the much higher spending going to MA plans?
Chernew: Medicare spending in general has been growing more slowly for a bunch of reasons. There have been some inexplicable reductions in utilization of certain types of care, and a shift to cheaper settings, hospitals to outpatient. But if your question is, can we improve the fiscal solvency of the Medicare program by cutting MA, the answer is absolutely, yes. Would we lose something? Yes. Will we lose a lot? If we cut modestly, I don’t think so. But that remains to be seen.
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https://doctorsofcourage.org/osmin-morales-md/
Following only a 7 day trial, 72 y/o Osmin Morales, MD, an interventional pain management physician in South Miami, FL was convicted Jan 12, 2024 of conspiracy to unlawfully dispense and distribute controlled substances, and six counts of unlawfully dispensing controlled substances. Just shows how the government propaganda is still convicting innocent doctors and people need to help stop this.
So how is this being accomplished? In the DoJ report, they even say
“Under federal law, a physician is authorized to dispense (prescribe) controlled substances only when there is a legitimate medical basis for doing so, and the dispensing is consistent with accepted standards of professional medical practice.”
But then, to continue the government propaganda, the report says that Dr. Morales
“established a purported pain management clinic in which he issued prescriptions for controlled substances, principally oxycodone, morphine, and alprazolam… to most patients who sought them, without any appropriate medical basis.”
But when questioned, government agents always say they can’t determine legitimate medical practice because they aren’t doctors. They don’t have to, though, since they have everyone in America believing their propaganda that opioids cause addiction.
To stop these attacks on doctors, we must get the CSA repealed. Why? Because opioids need to be treated like any other non-controlled drugs that a doctors prescribes. For example, according to the government report (which we, BTW, can take with a grain of salt),
If this was standard medications and not controlled substances, none of these actions would be considered illegal by anyone, even the DOJ. They shouldn’t be considered illegal for controlled drugs either. If a doctor can’t be at the office every day, but patients need their medications to continue, and the prescriptions, by law, can only be written for a month at a time, then it shows a compassionate, caring physician to make sure the regular patient can pick the scripts up. And if the doctor wants to consider that an office visit and doesn’t bill insurance for it, then the standard office visit price should be allowed. $250 is low for a standard office visit today. The doctors not taking insurance in my area charge $350. And Florida is probably even more expensive.
These “pain medicine experts” that the government pays to say whatever they are told to say on the witness stand will someday answer for their crimes to humanity. How can they say, in this day and time when a pain patient doesn’t even know if they will get their pain medicine, that there isn’t a need for an anti-anxiety medicine like alprazolam? And the attacks on opioids and benzodiazepines is purely bogus government propaganda to attack physicians. They have been prescribed together for 50 years without any major problems.
But what about telehealth? Couldn’t the doctor have conducted a virtual visit with these patients? Telehealth is accepted today. And if a pain management physician is alone in his practice, there must be a way for patients to receive their prescriptions in a timely manner so they don’t suffer or go into withdrawal. It would appear, though, that the DOJ report on the trial doesn’t mention this possibility. The visit could even have been conducted by phone call. Since pain patients have to be evaluated monthly, and usually the prescriptions are just continued, a face-to-face is not needed. It is even in the Controlled Substance Act that a face-to-face only has to be conducted every 24 months.
There is no such thing as a “maximum dose” with opioids. If they are using the 90mme’s based on the CDC guidelines, even the CDC came out with a revision stating that is wrong.
At the age of 72, Dr. Morales has savings, a home, cars, maybe a boat, that the government will confiscate so they can divide the proceeds among all of the divisions that helped in the investigation, from federal agencies to local law enforcement.
The media plays into this–even the websites for doctors. The headline on Becker’s ASC Review, a website for medical professionals, was
Those really guilty of using prescriptions for cash are the government agents, such as U.S. Attorney Markenzy Lapointe, DEA Special Agent Deanne L. Reuter, Assistant U.S. Attorneys Frank Tamen, Theodore Joseph O’Brien, Emily Stone and Mitchell Hyman, and the US Customs and Border Protection which helped in the case creation.
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I wonder how many times someone (individual or corporation) puts out an RFP (request for proposal) with a specific $$ figure attached. For someone to create a study to prove or disprove a specific conclusion. This is not an isolated situation with Dana-Farber, I have seen, over the years, numerous studies that have had questionable data used to facilitate the study producing a predetermined conclusion. We have all seen various federal/state agencies with agendas that do not match up with the “real facts”, but they continue to align with and support the agenda of the agency that employs them. According to this article, it seems that there can be little/no consequences for those doing such shenanigans.
https://www.statnews.com/2024/01/22/dana-farber-research-retractions-corrections/
A review of alleged data manipulation in studies involving four top scientists at Dana-Farber Cancer Institute has led to plans to retract six papers and correct 31 manuscripts, the institute confirmed on Monday.
The news comes as the famed cancer research and treatment center is now reviewing scores of studies co-authored by some of its leading researchers, including CEO Laurie Glimcher, COO William Hahn, and prominent scientists Irene Ghobrial and Kenneth Anderson.
Dana-Farber confirmed the retractions and corrections in progress in an email to STAT, which reported on Friday that researchers were preparing to retract one paper and correct others. The higher numbers were first reported by the Wall Street Journal, which also reported that Dana-Farber concluded three papers needed no corrective action. But the institute did not say precisely which studies would be retracted or corrected.
“Correcting the scientific record is a common practice of institutions with strong research integrity processes at which basic research is conducted. Some of the potential errors that blogger Sholto David flagged had come up in our ongoing reviews,” Dana-Farber told STAT.
During a conversation with STAT last week, the institute’s research integrity officer, Barrett Rollins, said that all of the cases that have been assessed thus far appear “credible,” a term meaning the allegation carried enough scientific merit to warrant more investigation. STAT did not receive immediate clarification regarding whether Dana-Farber had recently decided to retract or correct additional papers.
The institute’s review of past research involving these four scientists grew after David, a molecular biologist who blogs about research integrity, wrote a Jan. 2 post flagging issues with dozens of studies and the Harvard Crimson covered it. The cancer institute, a teaching affiliate of Harvard Medical School, noted in a statement that Dana-Farber had taken “prompt and decisive action” in many of the cases flagged by David for which data now under scrutiny were generated in a Dana-Farber lab.
The corrections in progress include correction submissions that are currently being prepared for submission, awaiting acceptance from journals, and corrections that journals have already accepted. An additional manuscript with a potential error is still under examination, according to Dana-Farber.
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Court considers pharmacist liability in opioid-related caseJudicial rulings in the large volume of opioid-related lawsuits continue to clarify pharmacists’ legal responsibilities that are broadly applicable beyond opioid litigation. A recent case from New Jersey addresses a novel approach to pharmacist liability. Rather than alleging that the defendant pharmacies were liable for causing a patient to become addicted to dispensed opioids, this recent case contended that the defendants’ pharmacists knew, or should have known, that the patient was already addicted to opioids and that their negligent dispensing of opioids exacerbated the patient’s pre-existing condition.
The plaintiff was the estate of a deceased patient. The estate sued four pharmacies that had dispensed oxycodone to the patient, sometimes in combination with alprazolam. The patient allegedly died as the result of the defendants’ negligence. The prescriber of the controlled substances was also sued, but that lawsuit was separated from the pharmacy litigation.
The lawsuit against the defendant pharmacies alleged that pharmacists honored prescriptions for the patient “that they knew or should have known were negligently, carelessly, and or recklessly prescribed, given their amount and frequency.” The lawsuit alleged that the pharmacists “engaged in professional malpractice by not noticing that the amount and frequency of the prescriptions were for addictive medications outside reasonable practice, and by not refusing to fill those prescriptions.”
The pharmacies moved to dismiss the lawsuit based on the learned intermediary doctrine, contending that it is the physician, and not the pharmacist, who has a duty to warn the patient. The pharmacies also contended that the lawsuit did not properly allege proximate cause, because it was the patient’s underlying condition that caused her death, and not any action or inaction by the pharmacists.
The trial court granted the pharmacies motion to dismiss the lawsuit, and the plaintiff appealed.
On appeal, the court first considered the defendants’ defense based on the learned intermediary doctrine. The court recognized that the doctrine applies to pharmacists who accurately process prescriptions “issued in amounts and at frequencies within reasonable medical standards.” According to the doctrine, it is the prescriber, and not the pharmacist, who is the learned intermediary and who has the duty to warn the patient of medication-related risks. However, the plaintiff’s lawsuit did not allege the breach of a duty to warn the patient of risks. The lawsuit alleged the breach of a duty to refuse the improperly issued prescriptions. Therefore, the learned intermediary doctrine was ruled to be inapplicable.
The appellate court also disagreed with applicability of the defendants’ proximate causation defense. The court noted that a plaintiff need not allege that a defendant’s conduct was the only cause of the plaintiff’s injury. Rather, “a plaintiff may recover if he establishes that professional negligence increased the risk of harm posed by a preexisting condition and the increased risk was a substantial factor in producing the harm.”
The dismissal of the lawsuit was reversed on appeal and the case was remanded to the trial court for further proceedings.
This case illustrates a variation of the legal principle known as the “eggshell plaintiff” doctrine. Under that doctrine, an allegedly negligent defendant must accept the plaintiff’s condition when the plaintiff was presented to the defendant, even if that condition is as fragile or as delicate as an eggshell. The defendant cannot escape liability by arguing that the action taken by the defendant toward the plaintiff would have been harmless if the plaintiff had not been so susceptible to the harm.
The significance of this case is that pharmacists may have a legal duty to know a patient’s underlying condition, and to refuse pharmaceutical products or services that exacerbate the underlying condition. Pharmacists can know of an underlying condition based on a patient’s medication history or information contained in the medication record. Suspicions about a patient’s underlying condition that arise due to a pattern of medication use can be investigated by consulting with the patient or with the prescriber. ■
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Looks like the DEA has run out of valid reasons to go after some parts of the controlled meds distribution system. According to this article, it suggests that the DEA is going after missing “i’s” being dotted and/or “t’s” being crossed. Clerical errors that does not have a single thing to do with the diversion of controlled meds. Pt may start getting a lot of being told that “the med they need is in backorder and/or out of stock” What the Pharmacist is hoping that the pt doesn’t know about is that all pharmacies are required by state/federal law to keep a hard copy perpetual C-2 inventory. Of course, the pt can’t see those inventory sheets, as a lot of protected pt HIPAA information there, but the pt – under such circumstances – asked the pharmacist, if the inspector from the state board of pharmacy came in and wanted to check on the particular day that the pt was told there was no inventory in the store for the particular med/strength the pt’s Rx was for on a particular date/time. What would the inspector find? Some BOP’s consider lying to pts as unprofessional conduct. There is also some state pharmacy practice acts that require a pharmacy to keep in inventory Rx meds that is normally prescribed in their market area. It is anyone’s guess what a BOP will or will not enforce or take action on. Pharmacists within the state.
https://www.healthlawalliance.com/blog/dea-dangerous-new-agenda
As a former federal prosecutor for DEA cases beginning in 2008, the Agency’s shift has been gradual but remarkable. Back in the days before the Ryan Haight Act, the DEA was dealing with internet-based pharmacies that dispensed huge volumes of controlled substances from second-floor, strip mall locations. Similarly, the opioid epidemic in Florida was particularly rampant, with so-called “pill mills” that attracted patients up and down the I-95 corridor from Kentucky to West Virginia and beyond. That’s when Joe Rannazzisi, the DEA’s whistleblower from the 60-Minutes television show, launched the “Distributor Initiative” because DEA believed that downstream registrants, like pharmacies and physicians, were too numerous for DEA to effectively regulate.
Times have now changed. The Nation’s opioid epidemic has educated all of us about the pitfalls associated with miracle drugs that restore daily function and quality of life to millions of patients but overlap with difficult-to-manage scenarios involving addiction and misuse. In addition, many of the major wholesalers operate under compliance decrees and settlements that require them to police their customers closely. I helped build McKesson’s suspicious order monitoring program for independent and chain pharmacies and dispensing practices; these algorithms are incredible. As a result, we see less and less of those DEA cases involving lines around the block, hand-to-hand exchanges in parking lots, and security guards in waiting rooms.
But DEA is still attempting to recover from the scathing criticism and blame the Agency received as a result of the opioid epidemic. Was some of that blame unjustified? Yes, of course. But some of it wasn’t. Either way, the so-called pendulum has now swung dramatically towards stricter enforcement, and registrants better heed this trend because it marks a significant departure from DEA’s prior approach. For example, it has always been extremely difficult for law enforcement to pierce the doctor-patient visit and a pharmacy’s ability to rely on a physician’s order. Historically, this has limited the number of traditional “diversion” cases that can be brought.
DEA’s new approach, however, eliminates the need to prove actual “diversion” or “over-prescribing” to impose sanctions.
Specifically, DEA’s clever new agenda is to target registrants through routine DEA inspections or administrative warrants for “record-keeping” violations. In years past, such record-keeping violations would be resolved through letters of admonition (LOA) or minor civil and administrative fines. Not anymore.
Under DEA’s latest regime, alleged record-keeping violations are now the genesis of revocation and suspension proceedings brought by the DEA’s Office of Chief Counsel, and business-ending, death penalty fines imposed by U.S. Attorney’s Offices around the country. In short, a registrant need not “divert” a single pill to be stripped of his or her DEA registration, and a waterfall of board and licensing proceedings that will follow.
Finally, one reason that DEA’s new agenda is so scary is that DEA regulations are opaque, and DEA agents and diversion investigators each have their own interpretations of what those regulations require. As a result, we have been forced to defend pharmacists and physicians against DEA record-keeping allegations that were completely arbitrary and made-up. In short, if you have any concerns whatsoever about compliance with complex DEA rules and regulations, you need to get buttoned-up immediately. We are here to help with that ounce of prevention if needed.
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Some of the most dangerous people in our society are people with a law degree who get elected to a powerful position, become a judge or prosecutor, or are given a badge, gun, and laws to enforce and sometimes is allowed to make their own interpretations of those laws.
The current Texas AG, apparently decided to use his personal opinion and ability to impose his will on a pregnant female who had been told by her OB/GYN that the fetus she was carrying was unviable and would complicate her pregnancy and threaten her health and future fertility. I have read in other articles about this that the Texas abortion law has provisions to allow abortions under such circumstances. However, it was reported that the TX AG stated that this woman and her fetus either did not check all the “boxes” or “enough boxes” for her to be entitled to any abortion under TX law. Anyone who wishes to “get into the weeds/details” of this case. Here is a link https://www.theguardian.com/world/2023/dec/12/kate-cox-texas-abortion-case-explained
I just wonder what the cost was for this couple to go to court and the tax dollars that the TX AG spent to justify him exercising his ideology on this case.
https://www.medpagetoday.com/opinion/second-opinions/108291
Lately, I’ve found myself using the words “irrational” and “U.S. Court of Appeals for the Fifth Circuit” in the same sentence with increasing frequency. To that mix, I add, “dangerous.”
The latest misadventures from the Fifth Circuit include a ruling in favor of Attorney General Ken Paxton and anti-abortion groups that Texas hospitals receiving Medicare cannot be required to perform life-saving abortions to stabilize patients, despite federal guidance.
This grim beginning to 2024 in Texas comes on the heels of the Kate Cox case, one that I believe Paxton pursued without empathy or reason.
The same day that a lower court granted Cox the right to abortion for an unviable and complicated pregnancy that threatened her health and future fertility, Paxton fought the decision and intimidated physicians and hospitals with a threat that the ruling would not shield them from criminal charges for violating Texas’ abortion laws, should they be involved in Cox’s care. He was successful
In his argument, Paxton belittled the original ruling: “Judge Guerra Gamble is not medically qualified to make this determination,” ignoring his own lack of medical qualifications.
I see a couple of concerning themes here. The first is that the state of Texas has determined itself to be more qualified than trained physicians to practice medicine. Had Paxton been genuinely concerned with medical expertise, he would have respected the professional opinions of Cox’s physicians and would not need to threaten them with litigation.
The second is that Texas politicians’ “practice” of medicine is decidedly antithetical to the practice of medicine that I was taught. Our Hippocratic Oath is succinctly distilled into the phrase: “First, do no harm.” I do not see Paxton abiding by that credo either in his challenge to the federal guidelines on EMTALA and emergency abortions or in his efforts against Cox. Neither bullying patients by weaponizing the legal system against them nor prioritizing personal ideology over scientific evidence is considered good medical care. Furthermore, denying an emergency abortion to a medically unstable patient who needs one is the exact opposite of preserving life, especially when the fetus carries a deadly condition.
Ideology has governed the state of Texas’s “practice” of public health, as well as its “practice” of medicine. In November, the Supreme Court reviewed U.S. v. Rahimi the decision issued by the Fifth Circuit upending decades of federal law that had previously disarmed people subject to restraining orders for domestic violence.
The original Rahimi Fifth Circuit ruling ignores the facts: access to firearms is a highly significant predictor for intimate partner homicide, increasing the risk by 1,000% Furthermore, the children of abusive relationships are not exempt from abuse, and firearms are the leading cause of death among children in this country. The Fifth Circuit ruling disregards public health expertise and consequently endangers women and children.
The Fifth Circuit’s practice of medicine continues with further frivolous barriers to care. SCOTUS has agreed to review a decision by the court limiting access to mifepristone (Mifeprex) and imposing wholly unnecessary burdens and confusion
for patients who need this medication. These restrictions do nothing to improve patient outcomes or experience with mifepristone.
As physicians, we can follow neither our ethics nor the appropriate standard of care if politicians flagrantly disrespect our training. If they can undermine our careful decision-making so easily, what is the point of our expertise?
The medical students I train are already considering the politicization of healthcare in their future career plans. Despite ob/gyn becoming more competitive, many medical students are reluctant to consider residency in states with rigid restrictions. “I would like to train at an institution that teaches family planning. And I don’t think I’ll apply to [ob/gyn residency] programs in states where there are restrictions or bans on abortion,” said one of my third-years, who is already a valuable asset to our medical team.
If you drive away physicians with the threat of criminal charges when they don’t practice according to your personal beliefs, they will not come to your state.
Another casualty of ideological extremism? Women’s access to comprehensive reproductive healthcare.
Anti-abortion advocates will inevitably challenge me on this, but the anti-abortion “murder” argument is an egregious misrepresentation and oversimplification of healthcare decisions in which abortion is determined to be the best option for the patient. This position suggests that hordes of callous and irresponsible women will casually line up to dispose of infant children, given the opportunity. That is not happening. Nor is Texas’s misrepresentation of federal guidance on emergency abortions and EMTALA happening: that the guidelines strive to turn emergency departments into abortion clinics.
What is happening is that a group of politicians are dictating medical care without medical training, and endangering women’s lives. These decisions are tantamount to enforcing decidedly inferior medical care that disproportionately harms women, prioritizing personal belief over evidence-based medicine, and in my view, effectively codifying misogyny into standard of care. This most recent decision by the Fifth Circuit, which allows the denial of an emergency abortion to a critically ill and unstable pregnant patient, highlights the chilling truth that the life of the mother is not, in fact, a priority in the eyes of the law.
For a group that professes to value life, the politicians and courts of Texas are certainly demonstrating otherwise, with unyielding dedication to preserving a black-and-white ideology and enforcing it without nuance or compassion, without firm grounding in scientific evidence, and even at the expense of women’s lives.
I would lose my job very quickly if I practiced medicine this way.
If politicians wish to play doctor, we should hold them to the same standard. The situation has become dire for too many innocent people.
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