Author: Eli Stutsman

Defending physicians who prescribe opioids

Posted on June 21, 2016 by - DEA Prosecutions, Licensure

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.

These Oregon Medical Board and OHSU publications may serve you well

I am a healthcare defense attorney, not a healthcare provider, so my opinion is informed by others, and at this point my opinion on this 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 well served if you have followed these practice guidelines made available by the Oregon Medical Board and Oregon Health & Science University:

 

Purdue Pharma misleads physicians again?

Posted on June 18, 2016 by - DEA Prosecutions

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

Posted on June 17, 2016 by - Licensure

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

Posted on June 12, 2016 by - Appellate

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 an “easy” case, I can evaluate a single issue appeal in two to three hours, and then share my opinion with the trial lawyer and 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 legal issues are not simple and most cases (or “records”) are much more complicated than a single legal issue.

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

In a “hard” case, it can take ten to 20 hours before I will have an initial opinion to share with the trial lawyer and client.  Time permitting, this work can be completed to inform the decision to file the notice of appeal. It is nice when it happens this way, but it only happens this with advance planning.

Evaluating the merits of an appeal in a hard case, with a large record, multiple issues, 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 – and this next point is key – 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 in a hard case with no answers for a good result

The best example I have of such a hard case, with far more questions than answers at the start 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, however, I did not know what I could accomplish and nothing was certain other than my client could not accept the loss in hand. By the end, however, 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 the best interests of children.

There were also 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 of Appeals, with all ten judges participating. Later, after the Court of Appeals denied my clients any relief in a split 5-5 decision, the Oregon Supreme Court accepted 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 and legal precedent was against us.

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

Posted on June 10, 2016 by - Licensure

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

Posted on June 8, 2016 by - Licensure

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.

More on how to “pass” (or fail) your licensing Board interview

Posted on May 30, 2016 by - Licensure

Whether you are being investigated by the Oregon State Board of Nursing (OSBN), the Oregon Medical Board (OMB), or the Drug Enforcement Administration (DEA), your success during your interview is key to the successful resolution of the investigation.  Today I will share with you the experience of three clients – a nurse, a physician, and a dentist – all of whom went to interview within a 14-day span this month.  Two “passed.”  One “failed.”  Let my tell you why.

The nurse and the Oregon State Board of Nursing (OSBN)

Earlier this year I undertook the representation of a well-qualified and experienced nurse under investigation by the Oregon State Board of Nursing (OSBN).  She went to interview this month.  At one hour and 45 minutes, her interview was long, and seemed even longer with four of us in a room that was too small and too hot.  The interview was led by the OSBN nurse investigator and assisted by an OSBN advanced practice nurse, with my client the focus of attention.

The first hour of the interview was necessary to get at the core issues in this unusually complex case.  The OSBN’s investigator and advanced practice nurse were well prepared (aren’t they always?).  My client was also well prepared, however.

As we passed through the first hour of the interview, I was impressed by the depth of the discussion and by my client’s answers.  I privately marveled at how few members of the public will ever appreciate how carefully the practice of nursing is regulated in Oregon.  My client was subjected to questions for an hour and 45 minutes, by two investigators, and her interview had the tone of a thoughtful discussion.  She passed the test.  The case isn’t over, but my client did a stellar job, and representing her that day was professionally rewarding.

The dentist and the Drug Enforcement Administration (DEA)

I also prepared a dentist for an interview this month before the Drug Enforcement Administration (DEA). In this case, the dentist sought reinstatement of his DEA Registration, earlier surrendered.

In a December 7, 2015 post, I explained that in the right circumstances, reinstatement of a surrendered or revoked DEA Registration is possible.  These can be tough interviews, however, because in cases where a DEA Registration has been surrendered or revoked, there are usually a few “sensitive” issues.  Also, the interviews are conducted by DEA Drug Diversion Agents and, in my experience, there are always two of them.

This interview was nonetheless a success.  By the end of the interview, my client was advised he would have his DEA Registration back in four to six weeks, with a few temporary, common sense restrictions, but nothing that will interfere with his practice.  It doesn’t get much better than that!

The physician and the Oregon Medical Board (OMB)

In the same 14-day span this month, I was hired by a physician but, unfortunately, her interview occurred the week before I was hired, and she went alone, unprepared, and unrepresented.  She “failed.”  Let’s consider what my client was up against.  By the time of her interview at the Oregon Medical Board, the Board’s investigator, the Board’s Investigative Committee’s (IC), and the Board’s expert, had all finished their work.  Counting the Board’s investigator, the Board’s expert, and the four members of the Investigative Committee, six people were prepared to interview my client that day.  If you find yourself facing a Board interview, ask yourself the following questions:

  • What have you done to prepare?
  • Who has given you legal advice?
  • Who has prepared you?

If you cannot answer these simple questions in a reassuring manner (without rationalizations or excuses), you are not ready for your interview.  As I have said many times before, an interview with your licensing Board is no place to show up and see what happens.

The moral of the story

In this case, there is little doubt in my mind that this physician should have passed her interview, had she been ready.  But she wasn’t ready.  Don’t let this happen to you.  An experienced healthcare defense attorney will help you prepare for your interview.

How to “pass” (or fail) your licensing Board interview

Posted on May 21, 2016 by - Licensure

Whether your are a physician, pharmacist, or nurse defending against an investigation by the Oregon Medical Board, the Oregon Board of Pharmacy, or the Oregon State Board of Nursing, what I am about to share with you holds true.  At a minimum, you should expect your licensing Board to request (a) your written statement answering the complaint against you, and (b) your appearance at the Board’s office to sit for a recorded interview.  To help my client’s obtain a good interview, I keep the following points in mind while helping them prepare their written statements, and while preparing them for interview.

Know your case and accept responsibility where necessary

Although many Board complaints are full defensible, many others are not, and it is important to know which type of case you have.  While it is professionally rewarding to defend a licensee 100 percent, when a mistake was made, it is often preferable, if not necessary, to acknowledge the mistake, accept responsibility, provide mitigating context, and take corrective action to prevent a recurrence of the mistake.  Your licensing Board will respect either approach, so long as we have correctly identified which type of case you have.  An experienced healthcare defense attorney will help you accurately evaluate your case and develop a plan to defend your medical license.

Be well prepared for your licensing Board interview

If you do not know what the issues are, or what the likely questions will be, you are not prepared for your interview.  It is that simple.  Please know that an interview with your licensing Board is no place to show up and see what happens.  If this is your approach, you will fail.  In sharp contrast, an experienced healthcare defense attorney will identify the controlling legal issues and the questions you can expect to be asked during your recorded interview.  Please also know that your investigator will be well prepared to interview you and, by the time of your interview, your investigator will have drawn tentative conclusions about your case.  Some of the questions you will be asked will be well thought out in advance and, in those cases where your written statement was misleading, some of the questions will be pointed, and you will likely face a series of questions intended to expose your lack of candor.  Do not let this happen to you. An experienced healthcare defense attorney will help you avoid this trap.

Do not attempt to mislead your licensing Board

You are taking a huge risk if you attempt to mislead your licensing Board, either in your written statement, or while answering questions during your recorded interview.  Your licensing Board has resources, and it will conduct a background check.  One or more investigators will investigate your background, and the investigators are very skilled at what they do.  If, for example, you had a bad experience in another state, especially one involving a similar issue giving rise to your current licensing Board investigation, you should expect the out-of-state incident to be discovered and investigated by your licensing Board.  Please know that any effort to mislead your licensing Board about the prior out-of-state incident will almost certainly be exposed and, when this happens, you will have lost your credibility with your licensing Board.  Do not let this happen to you.  The better approach is to know when to acknowledge the mistake, accept responsibility, provide mitigating context, and take corrective action to prevent a recurrence of the mistake.  This is delicate work, requiring the assistance of an experienced health care defense attorney, to ensure you are adequately defended.

Conclusion

In sum, to ensure a good interview, you need to accurately evaluate your case, you need to be well prepared, and you need to be candid when answering questions, all the while defending yourself and protecting your license.  This is difficult work, and it requires the assistance of an experienced healthcare defense attorney to do it well.

Caution: Do not represent yourself before your licensing Board

Posted on May 15, 2016 by - Licensure

I have written about this subject before, but the situation keeps reoccurring, and the “lesson” keeps repeating itself, so I will repeat myself:  Do not represent yourself when you are under investigation by your licensing Board.  Here are three recent examples of what can go wrong:

Example #1 – A pharmacist before the Oregon Board of Pharmacy

The first case involves an investigation by the Oregon Board of Pharmacy.  In this case, the pharmacist met the standard of care expected of a pharmacist when presented with a suspect prescription. Unfortunately, the pharmacist was so focused on the mistakes made by others that he (1) declined to provide the Board with a written statement and (2) appeared for his recorded interview prepared to talk about the mistakes of others, and little else.  The recorded interview went poorly, and the Board of Pharmacy issued a Notice of Proposed Disciplinary Action, threatening significant discipline, including probation and loss of pharmacist-in-charge (PIC).  The pharmacist hired me soon thereafter.  After completing my review, I find that the pharmacist had a near-perfect explanation (or defense) but, without the benefit of experienced legal advice, he failed to present that explanation when it mattered most.

Example #2 – A physician before the Oregon Medical Board

The second case involves an investigation by the Oregon Medical Board.  In response to the Board’s request, the physician submitted a written statement that was too short given the subject matter of the Board’s concerns.  The physician also appeared for her recorded interview before the Investigative Committee (IC) without adequate preparations.  The physician hired me after the Board requested that she consent to (1) an Interim Stipulated Order (ISO) significantly restricting her practice, and (2), an Order for Evaluation subjecting her to an expensive, out-of-state assessment, of her ability to practice medicine.  Although the Board’s requests may reflect poorly on the physician, with the benefit of my experience, I do not see the Board’s action as an accurate assessment of the situation, because I know the physician was unrepresented by legal counsel, and under prepared when it mattered most, i.e., when she submitted her written statement and when she attended her IC interview.

Example #3 – A nurse before the Oregon State Board of Nursing

The third case involves an investigation by the Oregon State Board of Nursing (OSBN).  In this case, the Board of Nursing made several offers to settle the case but, without the benefit of experienced legal counsel, the nurse failed to appreciate that the Board’s settlement attempts were offered in an effort to avoid discipline.  After several failed attempts to reach a compromise, the Board lost patience and voted to discipline the nurse, at which point, the nurse hired me.  Even the simplest of cases can become difficult when the parties are polarized against one another.

The lesson: Do not represent yourself before your licensing Board

The three cases summarized above, involve three different licensing Boards, and three different situations where things went poorly for the licensee.  In the first and second cases, the licensing Board sought serious discipline, and in the third case, the licensing Board sought minor discipline. The first case should have been easily defended and the third case should have been easily settled, while the second case needed to be developed and defended.  All three cases, however, have one thing in common:  The licensee mistakenly decided to proceed alone, without legal representation and, in each case, the licensee came to regret that decision.  Do not make this mistake. If you are a licensed healthcare provider facing an investigation by your licensing Board, I urge you to seek legal counsel from an experienced healthcare defense attorney at the first opportunity.

One way to evaluate an expert’s qualifications when defending against the DEA

Posted on April 3, 2016 by - DEA Prosecutions

Ask yourself: How many doctors has the expert’s testimony convicted?

I have the privilege of defending physicians, pharmacists and nurses before state licensing Boards and the Drug Enforcement Administration (DEA). In one such case defending against the DEA, there was much discussion about which expert physician had the better qualifications – our expert, or the the government’s expert? Each was capable of qualifying as an “expert witness,” but I feared my client, the defendant-physician, took too much comfort in the better qualifications of his expert. I feared this nuanced discussion of which expert witness had the better qualifications was creating a false sense well-being mere weeks before trial. For me, perhaps the more important question is how many doctors has the expert’s testimony convicted?

Do not dismiss the DEA’s expert witness

One thing is certain, if the DEA’s expert witness has led a jury to convict another physician, that’s a dangerous witness, despite any perceived lack of qualifications. In my experience, it is not the expert witness’ qualifications so much as it is what the expert is willing to say to a jury.

And do not become complacent

I can tell many stories where the physician believed the risk of conviction, or the risk of a lengthy prison sentence, was low. In my experience, physicians and their families often rationalize why they won’t be convicted, or, if they are convicted, why they will receive a lenient sentence, perhaps probation, or time served, or one year, only to be sentenced to 5 years or more, and in one case, to 15 years. While I have obtained good results, and have even obtained the release from prison of two physicians, most often, it doesn’t happen that way. If you want to see for yourself, search the internet using some of these search terms: “physician convicted,” “doctor convicted,” “physician sentenced,” “doctor sentenced,” “physician acquitted,” and “doctor acquitted.” You will soon discover that good results for defendant-physicians facing DEA prosecutions are few and far between. Prepare accordingly.