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: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS

For Medical Doctors, Doctors of Osteopathy, and Physician’s Assistants:

An Apple A Day Keeps the Doctor Away, and Compliance Can Protect You from the D.E.A.

If you are an MD, DO or PA, you worked very, very hard, for many, many years to earn your degree and license, and build your practice to success. You didn’t suffer through medical school or undertake grueling PA training in order to get indicted. So why let investigative priorities dictated by Washington politicians and bureaucrats, which translate into aggressive and sometimes reckless law enforcement activity, target you unfairly and threaten your life’s work?

It is a sad truth of healthcare practice today that providing patients with needed relief for severe, chronic or debilitating pain can be dangerous business. Dangerous because you have the D.E.A., the F.D.A., Medical Boards, state regulators and local law enforcement looking over your shoulder to see whether you are “prescribing without a legitimate medical purpose” or “practicing outside the accepted standards of medicine.” Who even knows what those vague statements mean in a given situation? Whose judgment should control – that of the healthcare professional, or of a federal agent without a day’s medical training?

As many questions as current law enforcement policy and practice beg, most healthcare practitioners are not prepared for the day when the D.E.A. shows up with a warrant, accusing them of being nothing more than highly educated drug dealers. Such heavy handed tactics – in use with alarming frequency across the country, and boasted of by law enforcement agencies – can rattle even the most ethical and seasoned practitioner.

Be ready. Be in compliance with the laws governing prescription of Schedule II painkillers and pain medication, and let the Meister Law Offices help. Do this before the door-knock, before the subpoena, before the administrative inspection, before the D.E.A. or its counterparts have made up their minds about you. You can’t necessarily stop the government from investigating you, but if you are in compliance with laws governing prescription of Schedule II painkillers and pain medication, you don’t need to stop anything. You need to prevail in the end, and the best chance you have is to be in compliance before the inquiry ever starts.

From patient intake to prescription practice, use of electronic databases to protect against doctor-shopping, from internal controls to ongoing government-sponsored training for you and your staff, we will tell you how you are in compliance, what areas might deserve additional attention, and how to maintain a compliant practice that serves your patients safely, ethically and properly within the meaning of the applicable criminal law.

Call the Meister Law Offices today at 213.293.3737 for a free consultation.

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