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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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

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PAINKILLER LAW: WARM BLANKET, COLD TRAIL

“The Warm Blanket” is how many opioid users describe the feeling of being under the drugs’ influence.  Orally or injected, and regardless of the reason(s) the drugs may be taken, this description has been documented across the user spectrum.  PAINKILLER LAW’s position on prescription drug abuse is that even if a patient or an addicted person – or an addicted patient – needs the warm blanket, that does not necessarily mean criminal or civil liability should rest with a prescribing healthcare provider.  In other words, in all but the most extreme cases, the blanket is warm, but the trail back to the ultimate question of “why?” is appropriately cold.

And speaking of “cold,” I don’t mean to sound cold or heartless saying that.  Grieving parents of deceased addicted children need comfort, not a lecture.  None the less, it is true that healthcare providers are generally NOT to blame for prescription drug abuse.  Here’s an example:

This past Thanksgiving Day in Minneapolis, two teens broke into a man’s home to steal prescription medication.  They weren’t looking for iPads or a flatscreen TV or even cash; they wanted pills.  The homeowner shot both teens dead.  For reasons not yet fully disclosed by police, he’s being charged with murder.  But my focus is the teen burglars.

Let’s assume the teens were addicted to prescription pills, let’s say opioids.  They committed the crime to feed their habit one way or another, either by planning to ingest the drugs themselves, or by selling them to buy other drugs for personal use.  Let’s further assume that the teens were first prescribed opioids by a legitimate healthcare provider.  They became addicted over time; to not feed the habit now would bring on the days-long agony of withdrawal.

Who is liable for the burglary?  The teens; they did it.  Who, if anyone, is liable for the act of killing them?  The homeowner, if he can’t claim self-defense, which you’d expect he’d be able to do.  But if the homeowner is charged, can he defend himself by blaming the doctor who prescribed the opiates to the teens?  Is there a causative link between the prescriptions, and addiction-fueled criminal behavior, sufficient to excuse the homeowner from killing them?  Should the healthcare provider be sued by the teens’ parents for wrongful death at the hands of the homeowner?  Should the healthcare provider’s act of prescribing be criminalized, independent of the burglary or murder case?  Should the very act of having written scrips for these teens end up with a doctor, or osteopath, or physician’s assistant, or nurse practitioner, stripped of their license and doing hard time?  Would a healthcare provider still be liable if the teens had not committed a crime?

There are already some states, like Florida, which criminalize “overprescription,” if anyone can define it, and I’d challenge you to come up with a durable, scientific and constitutional definition.  Then there’s my state, California, whose law conveniently doesn’t define “overprescribing” but whose law enforcement agencies still try and charge it.  And there’s a national law enforcement drumbeat to “do something” about prescription drug abuse by targeting legitimate healthcare providers writing reasonable prescriptions for approved drugs.

What are your answers to the questions above?  My answer to all of them is an emphatic “no.”  And even if reasonable people can disagree, that only means the issues are too complicated for law enforcement agencies to handle prescription drug abuse as though this were a straightforward issue with an easy remedy.  As the old saying goes, “For every complex problem, there’s a simple solution, and it’s wrong.”

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