PAINKILLER LAW BLOG: The FDA’s Original Blessing Isn’t a Pain Doc’s Original Sin

Doctors who prescribe opioid painkillers to chronic pain patients are, as we know, the subject of intense regulatory and law enforcement scrutiny today. Many of my doctor-clients are under investigation or being charged for supposed crimes arising out of their prescription writing. While every case is different, to me there is a universally applicable defense that should be raised on doctors’ behalf in court against a criminal charge.

That defense relates to lack of criminal intent, since opioids’ addictive power was not known or acknowledged until years after the drugs’ approval for mass use. Today, a criminal charge is at its essence a misguided and ill-considered way of blaming doctors for not having seen the future, for not having foreseen what would happen, even though government regulators and even the drug manufacturing companies didn’t see the abuse crisis coming, either.

The FDA originally blessed the prescribing of powerful and potentially addictive medication for chronic pain. We now know that the scientific evidence offered by Big Pharma about the safety of the medications for chronic pain was incomplete at best, wrong at worst. There are attempts being made today by counsel in various parts of the country to uncover any possible funny business or overly cozy relationships which may have existed between government regulators and private business (Pharma advocates) during the drugs’ approval process years ago. Is this the Erin Brockovich-like scandal waiting to break? Could be.

Whether or not a scandal exists or will be revealed, though, it still must be noted that doctors were the ones who were told by the FDA and the pharmaceutical companies that drugs like Oxycontin and other opioid-based painkillers were safe and effective for chronic pain. The addiction risk was significantly downplayed or underestimated by regulators and manufacturers. The drug companies unleashed a marketing and advertising juggernaut to persuade patients that the miracle pain drugs had at last arrived. That was then; this is now. And now that we know the drugs so frequently lead to addiction, we can change the advice and practice guidelines given to doctors, but we cannot hold them legally accountable for not knowing what the rest of us didn’t know, either – or what some people in the game may not have revealed – years ago.

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This past Sunday’s Los Angeles Times tells that Purdue Pharmaceuticals, manufacturer of Oxycontin, has for about a decade maintained a lengthy list of Oxy prescribers who in Purdue’s view potentially overprescribe or otherwise put patients at risk. Purdue won’t disclose the list, though, and doesn’t reveal the criteria for how it decides whether to share an occasional name with a medical board or the DEA. This is extremely troubling, and Purdue’s position raises several major legal and policy concerns:

1. Purdue’s being stingy about revealing names or the criteria for revealing names to law enforcement leaves the company’s motives suspect and prevents relevant government agencies from being alerted to possible overprescribing or patient risk.

2. The list has been maintained since 2002; Oxy has been on the market since 1996. The very existence of the list suggests that Purdue knows the addiction potential of the drug it for years has marketed as safe and generally non-addictive. Wouldn’t an overriding interest in competent medical practice, safe prescribing and patient safety compel the sharing of information between the manufacturer, doctors and regulators?

3. The company’s own partial list of “red flags” for signs of overprescribing or shady Rx practices — long patient lines, people nodding off in the waiting room (in the manner of heroin addicts’ being “on the nod”), cash transactions, and lots of young patients supposedly in excruciating and ceaseless pain — includes the same signs law enforcement looks for, too. Why not share this information?

4. If a doctor is on the list, and is prosecuted for prescribing-related criminal offenses, is the list now supposed to be relevant evidence of guilt?

5. If a doctor is not on the list, and is prosecuted for prescribing-related criminal offenses, is the absence of that doc’s name on the list now exculpatory evidence of innocence?

My guess is that the exposure of the list’s existence will prompt (a) prosecutors and investigators to start issuing subpoenas for the list; (b) defense attorneys like me to subpoena the list or otherwise make the list’s existence an issue in a medical provider’s defense; (c) legislation at the state or federal level, or the threat of legislation, to compel Purdue to share information with appropriate authorities; (d) Purdue’s worrying about civil liability for previously not disclosing the list.

I expect we’ll be hearing more about this issue in the future. In the meantime, medical providers and their insurers and malpractice defense lawyers should know what the signs of risky prescribing are, and know how to ameliorate patient risk and maximize the practice and the appearance of practice of competent, informed medicine. MEISTER LAW OFFICES 213.293.3737

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Comedian Chris Rock has a great bit about why we should all be vigilant for evidence of prejudice or bigotry. As he puts it, when illegal aliens are targeted, “I start listening, because I know blacks and Jews are next.” Then he looks at his watch and adds, “That train’s never late!” This lesson of vigilance is extra important today for all medical providers who prescribe opioids for chronic pain.

For months now, law enforcement has been leading the charge against so-called corrupt doctors and others who prescribe what are viewed as excessive amounts of opioids. In my view, as you know from previous PAINKILLER LAW blog posts, law enforcement’s leadership in this area amounts to putting the cart before the horse: Cops should not be telling doctors how to treat patients. But very recently there has been a slew of crucial developments that sends an unmistakable signal to prescribers, to the risk managers who help insure them, and to the malpractice defense attorneys who defend them. Attention must be paid, or prescribers will get in trouble, risk managers will write a lot more checks, and malpractice attorneys will not prevail using old arguments. And, of course, patients could be unsafe.

To have your ear to the train tracks on this issue is to know that now the scientific evidence is starting to match law enforcement thinking. This means a provider who does not keep up with scientific advances, and information provided by a source other than the pharmaceutical industry, risks getting run over by the oncoming locomotive of opioid reform.

Consider developments from just the past two weeks:

-The Centers for Disease Control’s director declares that too many doctors are prescribing too many opioids for too many people, with deadly impact and little patient improvement.

-The American Medical Association’s new recommendations on opioid prescribing acknowledge the CDC’s position and urge a significant shift in direction by opioid prescribers.

-A Harvard Medical School study finds it inconclusive that opioids are effective in the treatment of chronic pain.

These statements and studies have profound implications: If you as an opioid prescriber practiced in a way that even six months ago was roughly in compliance with the state of scientific knowledge, it would be harder to pin a crime on you if something went terribly wrong with a patient. But now, in the face of evidence from leading scientific and medical authorities which up-ends previous thinking about opioids for chronic pain, a practitioner who doesn’t adjust and adapt and possibly wholesale reform his or her methods of practice is putting themselves on a perilous path. It’s time for opioid prescribers nationwide to shift their practice methods to reflect and incorporate the CDC’s and AMA’s statement and recommendations. To ignore the advancing science is to invite law enforcement scrutiny, and deny yourself the chance to say, “As soon as the science changed, so did I.” Don’t get hit by an oncoming train. MEISTER LAW OFFICES 213.293.3737

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PAINKILLER LAW: When Crime’s All You Look For, You See Too Many Criminals

If you wake up every morning, strap on a badge and gun and go fight the War on Drugs, you come to view the world in a certain way. If your goal for each workday is to go in peace and not come back in pieces, your perspective on society, people, crime and your role in combating evil are invariably shaped by your experience. That’s why it’s a mistake for the DEA to bring its ordinary approach against drug crime to the issue of prescription drug abuse. But that is just what the agency is doing. It is basically treating like a criminal any healthcare professional who shows up on its radar.

At the recent joint conference sponsored by the California Medical Board and Board of Pharmacy, I heard the DEA speak about rampant drug diversion, pharmacists’ widespread complicity in prescription drug abuse, doctors wantonly prescribing outside the standard of care, drug dealers in white coats, and the DEA’s determination to crack down. The problem is, no one can quantify the degree of “complicity” by the nation’s pharmacists, or durably judge when a provider is prescribing outside the standard of care. The DEA says it’s happening, and its agents are the ones with the guns, and so, well, it must be happening.

The sense of things that I had coming into the conference was unfortunately not at all changed by what I heard there. The DEA’s talk was dominated by war stories of pharmaceutical distributors selling Oxy out the back door, of pharmacists ordering more than they need and keeping lousy records of where it all went, of doctors making megabucks writing scrips for no reason, and patients visiting websites devoted to the celebration of hallucinogens. Seriously, that’s what the speaker talked about. That’s clearly not the entire scope of the issue, and those characterizations don’t fairly define all medical providers or pharmacists or patients. None the less, the DEA is bringing its habitual mindset to a new class of cases and investigations – and a new “target” population – and that’s the wrong approach.

Clearly, the DEA is in reaction mode, just as Medical Boards nationwide are, and it’s being blamed for missing the early signs of what became a prescription drug abuse crisis. In reaction to the blame, the DEA is redirecting the pressure onto doctors, pharmacists and others who the DEA thinks are responsible for whatever the agency is supposed to be trying to stop. And what exactly is to be stopped? Who should decide whether a patient needs the drugs he or she is given: The prescriber, or the federal agent? If a doctor prescribes a lot of pills to a lot of patients, does it mean he or she is operating a pill mill? If a pharmacist fills prescriptions, is the pharmacist automatically part of the problem? And if the meaning of “outside the standard of care” can’t even be succinctly articulated in the law, how are law enforcement agents to know where the line is, BEFORE they decide a practitioner or pharmacist is dirty?

These are the questions all of us must vigilantly continue asking, persistently and if need be peskily, in this latest iteration of the War on Drugs. There is no easy answer, no matter what the DEA might think.

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PAINKILLER LAW: Fear and Self-Loathing in the Medical Academy

A recent article by Drs. Zachary Meisel and Jeanmarie Perrone, who teach at the University of Pennsylvania Medical School, asks whether “conscientious and well trained” doctors are to blame for prescription drug abuse. The authors say “yes.” That is, they say doctors are partially to blame, but the authors stay silent on why anyone else might be. That silence is damning, the good professors’ assessment is wrong, and their article is of great concern.

Not only is Rx abuse far too complex a problem to “blame” on any one constituency, but even more critically, it is always unsettling and even scary when one or two members of a profession presume to apologize on behalf of their colleagues nationwide for some perceived wrong. Today across the country we are seeing what the White House Drug Czar has called an “epidemic” of Rx abuse. We are also in response seeing a misplaced, hamfisted law enforcement approach to what is, in all but the most extreme cases, a public health problem. Federal and state law enforcement agencies will only be emboldened by an article whose glittering generalities
help legitimize the illegitimate and ill-advised belief that routinely going after doctors for alleged criminal conduct is the solution.

So are doctors to blame? In PAINKILLER LAW’s view, no, except in the most extreme cases. If a healthcare provider screens a patient carefully, does a thorough exam and makes an informed diagnosis, prescribes within the boundaries of established safety for an approved drug, counsels the patient on the possibility of addiction, monitors the patient conscientiously, verifies with any available prescription drug database, and uses his or her best judgment about how the patient is doing, what is the basis for a criminal charge against that doctor in the event of addiction or an overdose? Can the authors enlighten us, please, before asserting that good doctors are partly to blame?

Who else might be to “blame?” Patients themselves? That notion borders on blasphemy within the White House Drug Czar‘s Office; don’t be “blaming the victim,” the reasoning goes. What about Big Pharma? The drug companies marketed the pain-relieving powers of Oxy and its many opioid cousins back in the late 1980′s and early 1990′s. Were they wrong about the pain-relief qualities of the medications? Did they purposely understate the potentially addictive qualities of the drugs? What about medical schools and the philosophical and educational change that took place around the same time, so that med students would be trained to acknowledge and treat severe pain? Should we indict your school’s Academic Senate?

The point is, it’s too easy, suspiciously easy, to blame doctors, and that’s precisely what should make folks like Professors Meisel and Perrone think twice and choose their words carefully before they effectively if inadvertently bless today’s ill-conceived law enforcement priorities. Because if they’ve ever written a pain scrip themselves, they may have just made what an excitable cop or prosecutor might call a confession.


The Meister Law Offices

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An important article in today’s Los Angeles Times raises important questions and doubts about the appropriateness of prosecuting healthcare providers when a patient fatally overdoses on prescription painkillers.  In Los Angeles County now, Dr. Hsiu-Ying “Lisa” Tseng has been charged with triple murder – murder! – in the overdose deaths of three patients to whom she prescribed pain medication.  I have always thought these charges are excessive, and I think it’s a dangerous precedent to start prosecuting MD’s, DO’s and PA’s for something as grave as murder.  The theory of murder is that the patient was addicted, the doctor knew it, the doctor kept writing prescriptions, the patient overdosed fatally, and the doctor was so reckless and indifferent to human life by writing the scrips that the doctor may as well have wanted or intended to kill the patient.  The theory is ridiculous, and shame on the District Attorney’s Office for leading the grieving families of the patients to believe “justice will be done” in the form of a murder conviction.  I predict the DA will fail at trial; whether a lesser theory of homicide will succeed, I don’t know.  But murder?  That’s way over the top.

Don’t let anything close to this happen to you.  Call the Meister Law Offices at 213.293.3737 for a free consultation about Painkiller Law:  Criminal Law Compliance for Healthcare Providers, or email us at

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