Month: June 2016

Defending physicians who prescribe opioids

Experiences of a healthcare defense attorney

I have defended physicians, pharmacists, and prescribing nurses from prescription drug charges by the Drug Enforcement Administration (DEA) long enough that I well remember the following events:

  • the short-lived FAQ’s briefly posted to the DEA’s website (the FAQs were removed from the DEA’s website because pain advocates and defense lawyers cited the favorable FAQ’s in the courtroom);
  • the “Quick Reference Card,” (the Quick Reference Card was a highly formatted legal crib sheet used by prosecuting attorneys in the courtroom, but it was discontinued due to its misstatements of the law of drug diversion);
  • the argument that opioid dosing is to be determined “titrating to full function” (finding the optimal dose to improve daily functioning – the best analgesia with the fewest side effects; but was this ever the standard?); and
  • the day in 2007 that Purdue Pharma pleaded guilty, and paid a $630 million settlement, against federal charges that it misled healthcare providers about the risks of OxyContin.

Overtime, I have accumulated the type of experience that causes me to offer cautious advice to prescribing physicians treating chronic pain with opioids. Cautious advice will sometimes disappoint a prescribing physician, and will certainly disappoint the physician’s patient seeking more aggressive treatment. I am, however, a healthcare defense attorney, and my experience includes keeping physicians out of prison, and winning their release from prison once they are there. In other words, my goal is to keep you out of trouble and cautious advice furthers that goal.

The pendulum has swung: Treat chronic pain cautiously

It is based on my experience that I can assure prescribing physicians and nurses that the treatment of chronic pain with opioids exposes you to scrutiny by the Oregon Medical Board, the Oregon State Board of Nursing, and the Drug Enforcement Administration. Based upon two recent experiences, I also detect that the pendulum has swung, and the emerging practice standards and protocols governing the treatment of chronic pain with opioids are more detailed than ever.

This OHSU publication may serve you well

I am a healthcare defense attorney, not a healthcare provider, and at this point my opinion on the subject is not fully informed. Nonetheless, if you are a prescribing physician or nurse treating chronic pain with opioids, and you come under scrutiny by the Oregon Medical Board, the Oregon State Board of Nursing, and/or the Drug Enforcement Administration, you may be will served if you have followed the practice guidelines set out in the following publication by the Oregon Health Sciences University: Guideline for Safe Chronic Opioid Therapy Prescribing For Patients with Chronic Non-cancer Pain, which may found at: http://www.ohsu.edu/gim/epiclinks/opioidresources/OHSU_Opioid%20Guideline_1%2014.pdf

Purdue Pharma misleads physicians again?

I have been defending physicians, pharmacists, and prescribing nurses from prescription drug charges by the DEA long enough that I well remember the day in 2007 that Purdue Pharma pleaded guilty, and paid a $630 million settlement, against federal charges that it misled healthcare providers about the risks of OxyContin. Several of my physician clients during that period of time pointed to the misleading material they relied upon. Less than ten years later, here we go again. As reported by the Associated Press on June 10, 2016:

“The New Hampshire Attorney General’s office is targeting the maker of Oxycontin, a top selling prescription painkiller, with an investigation into whether it downplays the risks of addiction when marketing pain pills to doctors and other prescribers.”

And:

“. . . the company [Purdue Pharma] is no stranger to lawsuits: It pleaded guilty and paid a $630 million settlement in 2007 for federal charges that it misled doctors and patients about the risks of OxyContin. The OxyContin the company now produces uses a new formula that the company claims is less addictive.

“The new court filings allege Purdue is continuing to “engage in the type of deceptive marketing” that resulted in the 2007 settlement.”

Physicians, pharmacists, nurses caught in middle

Physicians, pharmacists, and prescribing nurses treating chronic pain are caught in the middle between the demands of patients and the scrutiny of the Drug Enforcement Administration (DEA), a difficult situation that is exacerbated by the ever-changing practice standards and, at times, misleading marketing by a prominent drug manufacture. The latest litigation is still its early stages, however, with the lawyers presently battling over discovery (the exchange of documents and other information), and alleged conflicts of interests. It will be interesting to see where this latest round of litigation against Purdue Pharma leads.

Defending a licensing Board complaint during the first few days

You’re a physician, pharmacist, or nurse, and you just learned a complaint has been filed against you with the Oregon Medical Board, the Oregon Board of Pharmacy, or the Oregon State Board of Nursing. Now what?

Stop, collect your thoughts, establish the first deadline

If you just received word-of-mouth notice, or a letter from your licensing Board, time is momentarily on your side, so take advantage of it. Avoid knee jerk reactions. Whatever you do, do not call your licensing Board or the investigator that sent you a letter. You’re not ready. You’re too emotionally involved. Instead, establish the first deadline. Get time under control. Stop. Think.

Don’t assume you know the substance of the Board complaint

It is only natural to speculate about the nature of the complaint. The tendency is to speculate based upon what you know, and then rationalize why the Board complaint is unfounded. The problem with this approach is that your knowledge of the complaint is most often limited, and your conclusions may therefore be wrong. This is no way to plan your defense.

Retain a healthcare defense attorney with experience defending licenses for physicians, pharmacists, and nurses

The better approach is to have a healthcare defense attorney contact the investigator, to learn about the complaint and to further discover what most concerns the investigator. Be aware that this call to your investigator is not a call you can make well, because once the investigator explains the basis of the complaint, a reaction will expected of you. It’s only natural; this is the way conversation works. You, however, will not be prepared to answer. Yet there you are, on the phone with the investigator, your mind racing, wondering how to respond to fill the silence. This is no time to be experimenting with answers. Again, the better approach is to have an experienced healthcare defense attorney contact the investigator. Your attorney will then share this information with you in a private setting where the issues and concerns may be thoughtfully explored, without risk to you. Remember, your best answer to the complaint will take some time and work to marshal; it will not emerge extemporaneously during a first phone call with the investigator. Have your attorney make that first call instead.

Don’t blame others until you have explained your role

If others were involved in the circumstances setting up the Board complaint, do not blame them, at least not at first. For some, placing blame where it belongs is a strong personal instinct. If others were involved, they will be investigated or interviewed too. When it is your turn, the investigator wants to understand your role in the circumstances behind the complaint and, until your role is satisfactorily understood, blaming others will come off as evasive, uncooperative, and non-responsive. Don’t make this mistake. An experienced healthcare defense attorney will help you avoid this mistake. And remember, if your role in the complaint was truly small and non-contributing, it will not take long to explain, and a good explanation will reference the participation of others, from which the investigator will draw all appropriate conclusions. In the context of a medical Board investigation, blaming others requires a deft touch.

How to decide whether to file a notice of appeal

My practice includes appellate litigation in state and federal courts. Most often, I am recruited to join the litigation team soon after a ruling or finding has gone awry. As such, I am the new lawyer on the team, at the start of the appeal, the occasional second half of litigation. There are always many questions, but the key questions concern the likelihood of success on appeal and whether to file the notice appeal in the first place.

Evaluating the merits of an appeal in an “easy” case

In the “easy” cases, I can evaluate a single issue appeal in two to three hours, and then share my opinion with the trial lawyer and the client, A decision can then be made to file the notice of appeal, or not. It is nice when it happens this way, but it only happens this way in a small percentage of the cases for the simple reason that most cases (or “records”) are much more complicated than a single legal issue.

Evaluating the merits of an appeal in a hard case, with a large record, and much at stake

In the hard cases, where there is much at stake, and the merit of the potential appeal is uncertain, sometimes all you can do before the deadline to appeal is to determine that the appeal is colorable, in good faith, and has sufficient merit to move forward. Then, after the notice of appeal has been filed to protect the deadline, the decision to appeal can and should be revisited at each new phase of the work, until such time the decision to appeal is plainly justified, or not. In those cases where the decision to appeal turns out not to be justified, the appeal may be dismissed.

Moving forward one step at a time on appeal for a good result

The best example I have of such a hard case, with far more questions than answers at the beginning of the appeal, is the case of O’Donnell-Lamont & Lamont (260 KB). In this appeal, I eventually won a unanimous 7-0 decision by the Oregon Supreme Court, in which the Oregon Supreme Court applied a recent holding from the United States Supreme Court and reversed the Oregon Court of Appeals in favor of my clients. At the start of this appeal I did not know what I could accomplish. In the end, this appeal was a big victory, restoring custody of two small children to my clients, the maternal grandparents. This unanimous 7-0 decision by the Oregon Supreme Court was also an important victory for children throughout Oregon because it established the legal precedent to be applied in third-party child custody disputes, affording more protection for children.

As if that were not enough, there were several key accomplishments along the way. Until this appeal, the Oregon Court of Appeals had never granted reconsideration en banc, meaning by the full court, with all ten judges participating. Later, after the Court of Appeals denied my clients any relief, the Oregon Supreme Court chose this appeal as the vehicle to resolve a number of similar third-party custody issues in Oregon. The other similar pending cases involving the same subject matter were placed into abeyance (on hold) pending the outcome of this appeal. So, in the end, the Oregon Supreme Court reversed the Court of Appeals in my case, and the other cases too. All this from an appeal where, in the beginning, the merit of the appeal was uncertain.

Two “red flags” when interviewing a licensing lawyer to defend your medical license

Red flag #1: Blaming the licensing Board’s investigator

Earlier this year, a practitioner hired me as her second lawyer, and I took over the representation of her case. Later, after much of our work had been completed, she expressed surprise at how helpful the investigator had been. When I asked her why she was surprised, she explained that her first lawyer blamed the investigator, saying something like, “Oh, you have Jane Doe for an investigator, you’re in trouble.” That was unfortunate. I have worked with the same investigator and find her easy to work with. More importantly, I regularly represent nurses, pharmacists and physicians before the Oregon State Board of Nursing, the Oregon Board of Pharmacy, and the Oregon Medical Board, and there has never been a reason to blame the investigator. It is my opinion that if a lawyer you interview blames the investigator, keep interviewing lawyers until you find one that works well with investigators. Your interests will be better served in the short and long run.

Red flag #2: Utilizing a litigious approach with an investigator

Last year I had a chance to ask an investigator what she thought of the relatively small group of lawyers that routinely appear before her licensing Board. I was surprised to learn that some used a tough approach, keeping communications short, and often implying that a contested case hearing (litigation) would be necessary when, in fact, they seldom are. Needless to say, these lawyers, due to their uncooperative reputations, were not favored by the investigators. As my record will demonstrate, I am willing to advance tough litigation in defense of physicians, pharmacists, and nurses, but litigation must be reserved for the right circumstances.

More importantly, consider the disadvantage you may suffer because of your lawyer’s “tough talk.” For example, throughout the course of a licensing Board’s investigation, much information must be exchanged, and any alleged practice discrepancy prompting the complaint against you must be carefully evaluated. Consider also that you will most likely be interviewed by the investigator, and much of the work of the interview can be accomplished between your lawyer and the investigator, sparing you much grief. Whatever the cause of the complaint, solutions must be negotiated. Ultimately, the investigator will write the summary of your case, including recommendations, that will become the basis of the Board’s decision against your medical license. For all these reasons, it is my opinion that a cooperative and professional relationship between your lawyer and your licensing Board’s investigator will lead to the most efficient and complete exchange of information, and the best resolution of your case. Along the way, you will be better informed too.

Do not dismiss the power of your licensing Board

I have won significant federal court litigation defending health care providers, including physicians and pharmacists. Knowing this, a health care provider growing weary of defending against his or her licensing Board will occasionally ask why I can’t do more in his or her case. For example, one physician wanted me to sue the Oregon Board of Medicine in “a real court of law,” and one nurse asked whether I could obtain a Temporary Restraining Order (TRO) against the Oregon State Board of Nursing. The answer is almost always “No.” Let me explain why.

The 50 states regulate medical licensing and practice standards

In our State-Federal scheme of government, the power to regulate medical practice and licensing is reserved to the 50 states. Admittedly, there is federal “overlay,” but still, when it comes to ensuring safe medical practice through the licensing of physicians, pharmacists, nurses, that role and power belongs to the states.

The 50 states exercise their “power” through state agencies

You may recall from civics classes that state and federal power is spread across three branches of government, the Legislative, the Judicial, and the Executive branches. The Executive branch of state government is headed by the Governor, and the bulk of any state’s work is accomplished through a multitude of state agencies belonging to the executive branch.

Your licensing Board is a state agency

Whether you are a physician, pharmacist, or nurse, your licensing Board is a state agency, specifically empowered to ensure the safe practice of your profession (public safety) and the competency of each individual practitioner.

What you need to know: Respect your licensing Board

So, when the physician wanted me to sue the Oregon Board of Medicine in “a real court of law,” and the nurse asked whether I could obtain a TRO against the Oregon State Board of Nursing, you now know why the answer was “no.” Even when the complaint against you is wrong, or the licensing Board is wrong, the licensing Board is nonetheless fulfilling its role as a state agency regulating your profession. It is true that in some cases there may be an appeal to a state court (this happens occasionally) and, in the exceedingly rare case, an argument for a restraining order from a trial court (this has happened only once in my career), but this is not where you start. You start with the agency – i.e., your state licensing Board – because your state licensing Board is not only empowered to regulate your profession, it has the most power to do so, and your interests will be best served by taking that power seriously.