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.

Read More

PURDUE PHARMA’S SUPER SECRET LIST OF RISKY PRESCRIBERS: YOU CAN’T SEE IT.

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.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

Read More

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.

Read More

PAINKILLER LAW: HEALER BEWARE — MEDICAL BOARDS’ 2013 WISH LIST

2012 has seen the nation’s Medical Boards come under relentless scrutiny for allegedly dropping the ball on regulating healthcare providers who write prescriptions for opioids and other potentially addictive drugs.  2013 will see the Boards react in full.  We all know that when a Medical Board gets hit with criticism by Legislator A or Media Outlet B, the Board reflexively lashes out at Doctor C.   For you as a healthcare provider to know how to protect yourself from biased and careless official investigation, you need to know what your regulatory overseer is thinking, and how you could be at risk no matter how ethically and safely you do your job.  Here’s what is on Medical Boards’ “wish lists” nationwide for 2013:

1)  Criminal investigations, in addition to administrative inquiries, for any patient overdose death.  An excellent recent LA Times article roundly criticized the California Medical Board for what the paper viewed as lax oversight of doctors who lose patients to prescription drug overdoses.  The Medical Board’s first reaction will be to raise the stakes by initiating a more clearly criminal inquiry against a healthcare provider when any patient fatality is even partly attributable to prescription drugs.  The Board is out to vindicate itself.  Providers who underestimate the Board’s desire for vindication are operating at their own peril.

2)  Tightening up communication between coroners’ offices and Medical Boards.  It’s good policy for coroners to immediately notify Medical Boards whenever a death is attributed even partly to prescription drugs.  The danger, though, is what Medical Boards will do with the information as new reporting requirements become operative.  In the hands of Medical Boards desperate to rebuild their tarnished reputations, this could easily become a 1-800-WHO TO TARGET NEXT hotline.  That’s not what these new reporting laws intend, but I’m confident it will be their effect.

 

3)  Finding criminal and administrative liability when a provider gives prescription drugs to an addict.   Wait a minute:  Isn’t it permissible under federal and state law to prescribe controlled substances to an addicted person?  Yes.  In fact, doesn’t the law of many states expressly prohibit discipline against healthcare providers who do this?  Yes again.  But in the recent LA Times article cited above, a Medical Board investigator said that a patient’s death was “the inevitable result” of giving narcotics to an addict.  That sounds like a new theory of liability to me.  Take it from a defense lawyer:  An incorrect interpretation of the law does not always stop police from acting.  Healer beware.

I will have more to say on these particular topics, as well as what I think 2013 will bring for the broader issue of prescription drug abuse.  For now, take heed and make sure you’re in compliance with all the federal and state laws governing prescription painkillers and other drugs.  Remember that PAINKILLER LAW is here to help you.

info@painkillerlaw.com              213.293.3737               Meister Law Offices

Read More

PAINKILLER LAW: SEIZING OPPORTUNITY, CALIFORNIA LAWMAKER BOLDLY JUMPS ON BANDWAGON

This past Sunday, the LA Times ran a searing and exhaustively researched article on prescription drug abuse, called “Dying for Relief.” This past Monday, as is the fashion among legislators nationwide, a California lawmaker loudly reacted to the article and grabbed a headline of his own.

Ordinarily, a legislator’s jumping on the bandwagon after a big article runs in the paper isn’t news. But here it is, because in response to the national public health problem of prescription drug abuse, California State Senator Curren Price, Jr. is introducing legislation that targets healthcare providers for law enforcement action. A law enforcement approach to a public health problem typically scores political points and funds new multiagency task forces, while doing nothing to actually address the problem. And innocent people – here, legitimate healthcare providers writing legal prescriptions for approved drugs – get steamrolled in the name of public safety.

Price’s idea isn’t so outrageous: He wants coroner’s offices in California to automatically report patient deaths to the California Medical Board whenever a coroner concludes that prescription drugs caused or contributed to someone’s death.

But the devil will be in the details, because the Medical Board is under tremendous pressure to “crack down” or “do something” about Rx abuse and suspected corrupt healthcare providers. All this while California law doesn’t even define “overprescribing,” for example.

PAINKILLER LAW will be watching very closely for the language and implications of the Price bill. I’m concerned that whereas a coroner’s findings may be circumspect and sober, the Medical Board will eagerly grab the autopsy report and form a posse to go after the “bad guy.” Senator Price needs to be alert to the pressure the Board will put on him and his committee to give the Board too much latitude in investigating, accusing or proceeding against healthcare providers who’ve written prescriptions for potentially addictive drugs. The offense itself is not clearly defined, yet law enforcement will want broad discretion to target it. That’s putting the cart before the horse.

Contact PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS, for a free consultation. We want to help you verify, achieve and maintain compliance with the criminal laws of prescribing for Schedule II through V drugs.

213.293.3737 info@painkillerlaw.com Meister Law Offices

Read More