Month: June 2015

An old story finally told: How one party made one argument that won a reversal in the Ninth Circuit Court of Appeals

The Oregon Death with Dignity Act was passed by Oregon voters in November of 1994. Oregon’s novel law did not, however, take effect that year, but was instead immediately enjoined from operation by a federal District Court. Lee v. State, 869 F Supp 1491 (D. Or. 1994). I represented the sponsors of Oregon’s groundbreaking new law on appeal, and we won. In 1997 the Ninth Circuit Court of Appeals reversed the federal District Court and vacated its injunction, Lee v. State of Oregon, 107 F3d 1382 (9th Cir. 1997), allowing the Oregon Death with Dignity Act to go into effect, the first law of its kind.

Three parties appealed the federal District Court’s injunction

Three separate parties appealed the federal District Court’s injunction to the Ninth Circuit Court of Appeals. The three parties were:

  • the State of Oregon (defending the state’s new law);
  • a dying patient represented by American Civil Liberties Union (the ACLU); and
  • the public sponsors of the law (my clients).

Some might wonder why three parties appealed, and weren’t they all doing the same thing?

One party made the difference

At first glance, it would appear that all three parties – the State, the ACLU, and the law’s sponsors – were all doing the same thing. They were, after all, litigating in support of Oregon’s new law. What you may be surprised to learn is that on the key legal issue that won the appeal, the three appellants took very different legal positions.

The key legal issue that persuaded the Ninth Circuit Court of Appeals was “standing.” Standing is a concept rooted in Article III of the federal Constitution. To establish standing, the legal challengers of the Oregon Death with Dignity Act must have established that they suffered sufficient harm or injury to themselves. Mere hypothetical harm would not be enough to confer standing upon the plaintiffs. If the plaintiffs did not have standing, the federal courts would not have jurisdiction (power) to decide the case, and the plaintiffs’ case must be dismissed.

In this case, the State of Oregon decided not to argue that the plaintiffs lacked standing. The State explained that for reasons of judicial economy, it would prefer that the federal courts reach (decide) the legal merits of the case, rather than simply dismiss the case on a procedural basis. The State did not want to come back another day to litigate the same issues against new plaintiffs that may have standing.

Similarly, the ACLU decided not argue that the plaintiffs lacked standing because the ACLU works steadily to expand, not restrict, the application of standing. The ACLU prefers easy access to the federal courts in order to bring their many legal challenges, and standing is a barrier to easy access.

This left only us, the sponsors of the law, to argue that the plaintiffs lacked standing to litigate. Our goal was to win. We did not have other priorities. Standing became our key argument.

As history will tell, the Ninth Circuit Court of Appeals reversed the federal District Court on this ground alone, and, in the 17 years since, no federal court has ever reached the merits of the plaintiffs’ nonexistent, hypothetical injuries.

From a Constitutional perspective, the standing doctrine served its intended purpose by screening from the federal courts purely hypothetical claims of injury. Best of all, however, the standing doctrine provided us with the key legal argument to win a reversal and free the Oregon Death with Dignity Act from the federal District Court’s injunction.

The lesson: Seemingly like-minded appellants may have different legal interests

Although I could provide you with other examples from other appeals, this example make the all important point that seemingly like-minded appellants may have different legal interests and priorities that will influence, if not interfere with, important litigation decisions and tactics. With this example in mind, if you have a stake in a high profile piece of litigation, do not assume that seemingly like-minded litigants are necessarily implementing the best litigation decisions and tactics.

Common mistakes licensees make when communicating with their licensing Boards – Part II

Last week, I explained that if you are under investigation, the record you are creating is a public record, and it will serve as the record should your case proceed to a contested case hearing. This is why the communications you receive from your investigator are formal, cogent, and professional. Similarly, your lawyer’s communications, sent on your behalf, should be coordinated, thoughtful, and legally strategic. In the most difficult of cases, this approach is absolutely necessary to succeed, and in the easiest cases, this approach is still necessary to prevent mistakes. Here are a few examples of real mistakes made by licensees when unrepresented by legal counsel.

Example #1 – Gloria

“Gloria,” a physician, was practicing under a restricted license, and she sought to have many of her restrictions lifted or modified. She sent frequent one or two sentence emails to her investigator, asking questions, often using her smart phone, which added the line, “sent from my smart phone.” Gloria would often send follow up emails without allowing the investigator adequate time to answer her first email. Other times, Gloria would fax material to the Board’s investigator, using only a facsimile cover page and the investigator’s name, without any explanation. All of Gloria’s communications would eventually make it into her file, but those communication were too frequent, too casual, and unprofessional. Gloria also appeared to have a “tin ear” for the investigators requests and concerns. She wanted relief from the Board, but she was not providing what the Board wanted from her. Not surprisingly, both Gloria and her investigator were frustrated, neither one able to understand the priorities of the other, bringing forward progress to a standstill.

Example #2 – Sam

“Sam,” a physician, did his own research, and would occasionally find literature helpful to his case. Sam would attach such articles to an email and send it off to the Board’s investigator, without much explanation, but intending to prove that he was meeting the applicable standard of care. In one unfortunate case, Sam found an article with a seemingly helpful introductory summary, and he sent it to the Board. A thorough reading of the article, however, suggested that Sam’s practice protocols did not meet the exacting standards required by the authors of the article, something Sam did not learn until he was harshly examined during his interview. Despite the time Sam put into his preparations, he never generated, much less provided, a single, cohesive, persuasive explanation of his standard of care.

Lessons to be learned

Perhaps half of Gloria’s communications were unnecessary, if not irritating, to the investigator, and the other half should have been consolidated into a few thoughtful, timely, and responsive communications, that would have placed Gloria in a professional light. More importantly, before Gloria could be in a good position to request relief from the Board, she needed to understand and comply with the Board’s requests. Once these mistakes were corrected, forward progress was immediate, and Gloria got the relief she sought.

Sam had the right idea, because he needed to establish that he was meeting the applicable standard of care. Sam’s approach, however, set Sam up for a big loss. Sam acted hastily. Sam’s defense was not persuasive, and, at times, harmful to him. Sam’s various communications should have been consolidated into one or two timely communications, complete with thoughtful analysis, including end notes, a bibliography, and enclosures of the most helpful articles. Inconsistent authority should have been distinguished. Using this approach, Sam’s mistakes would have been avoided, and the art of persuasion honored. Needless to say, the type of mistakes Sam made are not easy to correct.

Mistakes are often easier to prevent that to correct

Overall, Gloria and Sam both communicated too freely, too casually, and too often with their licensing Boards. Gloria and Sam’s mistakes would have been prevented by experienced legal counsel. Experienced legal counsel will communicate less often, but more thoroughly and persuasively on your behalf.

Common mistakes licensees make when communicating with their licensing Boards – Part I

Knowing that you are under investigation by your licensing Board will, in the best of cases, create a sense of unease, and, in the worst of cases, create a sense of panic. How you respond when you are under investigation is crucial. If you are represented by experienced licensure counsel, your lawyer will take control of the communications and the deadlines. In doing so, your licensure lawyer will create a “comfort zone,” sparing you much grief and anxiety, while serving the greater purpose of providing you with legal representation.

What you need to know

If you are under investigation, the record you are creating is a public record, and it will be the record that is litigated should your case proceed to hearing. This is why the communications you receive from your investigator are formal, cogent, and professional – your investigator knows what he or she is doing. Similarly, your licensure lawyer’s communications, sent on your behalf, will be coordinated, thoughtful, and legally strategic. In the most difficult of cases, this is absolutely necessary to succeed, and in the easiest cases, this is still necessary to help you prevent mistakes.

Where the trouble starts

All too often, however, licensees defend their cases on their own, usually until one or more common mistakes become apparent, compelling the licensee to retain licensure counsel. Such mistakes often fall into two broad categories. Licensees in the first category, not sure what to do, but feeling the need to do something, communicate too freely, too casually, and too often, with their licensing Boards. Conversely, licensees in the second category, feeling overwhelmed, if not threatened, are slow to respond, or fail to respond at all. Next week I will share a few examples of common mistakes.

For pharmacists: What you need to know about reporting a drug loss or theft

Once you discover a drug loss or theft, time is short. The applicable Oregon Administrative Rule (OAR) requires that you report a “significant” drug loss or violation related to theft to the Board of Pharmacy within “one business day.” OAR 855-041-1030(2) & (3) (Reporting Drug Loss) provides as follows:

(2) The outlet shall notify the Board in the event of a significant drug loss or violation related to drug theft within one (1) business day.

(3) At the time a Report of Theft or Loss of Controlled Substances (D.E.A. Form 106) is sent to the Drug Enforcement Administration, a copy shall be sent to the Board.

To notify the Drug Enforcement Administration (DEA), go online and complete and submit a DEA Form 106. Print a copy and send it to the Oregon Board of Pharmacy, as required by OAR 855-041-1030(3), quoted immediately above. Never forget, however, that you are creating a public record. You are also reporting to the DEA and your licensing Board, both of which have significant enforcement powers. Consequently, you will be well served to have a competent attorney advise you throughout the reporting process. It is my preference to review, if not prepare, both reports.

A significant drug loss or theft will prompt an investigation by the Oregon Board of Pharmacy, and perhaps the DEA as well, depending upon the circumstances. The pharmacist(s), and especially the pharmacist in charge responsible for the pharmacy’s annual audits, perpetual inventories, and security of the pharmacy, will be exposed to additional scrutiny by the Oregon Board of Pharmacy and by the DEA. You will want competent legal counsel from the onset. If you proceed without competent legal counsel, you do so at your own peril.

What you should expect

If the cause of the drug loss or drug theft is not clear from the beginning, an investigation will certainly follow, and that investigation will continue until the cause of the drug loss or drug theft is fully known and understood by the Oregon Board of Pharmacy and, perhaps, the DEA as well. You will be interviewed. You should expect that one, or more, Board of Pharmacy inspectors will be involved until the case is resolved.

You should further expect that your pharmacy’s relevant annual audits and perpetual inventories will be requested and reviewed by pharmacy inspectors. Any shortcomings in your pharmacy’s inventory systems will prompt further review by the pharmacy inspectors. More will be required of the pharmacist in charge, as compared to a staff pharmacist, but all will need to be proactive in the investigation and resolution of any perceived lapse in pharmacy security. If the pharmacy’s inventory systems and procedures are legally inadequate, the responsible pharmacist(s), and especially the pharmacist in charge, will face additional scrutiny, and may face disciplinary proceedings.

If you are reporting a drug theft, and the theft was accomplished due to a security lapse, the Board of Pharmacy will pursue the security lapse until the cause of the security lapse is known. If the drug theft was accomplished after hours by someone other than a pharmacist, the pharmacy inspectors and the Board of Pharmacy will further want to know how, or why, a non-pharmacist had access to pharmacy keys and/or pass codes. OAR 855-041-1020 (Security of Prescription Area) requires the following:

(1) The area in a registered pharmacy where legend and/or controlled substances are stored, possessed, prepared, manufactured, compounded, or repackaged shall be restricted in access, in such a manner as to ensure the security of those drugs.

(2) The pharmacist-in-charge and each pharmacist while on duty shall be responsible for the security of the prescription area including provisions for adequate safeguards against theft or diversion of prescription drugs, and records for such drugs.

(3) When there is no pharmacist present, the pharmacy shall be secured to prevent entry. All entrances to the pharmacy shall be securely locked and any keys to the pharmacy shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge. When there is no pharmacist present, and it is necessary for non-pharmacist employees or owners to have access to the pharmacy, the prescription area shall be secured from entry as described in OAR 855-041-2100.

(4) Prescription drugs and devices and non-prescription Schedule V controlled substances shall be stored within the prescription area or a secured storage area.

(5) Any security system deviating from the requirements of this section, except as provided in OAR 855-041- 6310, shall be approved by the Board prior to implementation. Requests for such approval shall be in writing and provide a detailed description of the proposed system. A written description of such security system, as approved by the Board, shall be maintained in the pharmacy.

Finally, you should expect that the Board of Pharmacy investigation will continue until all discrepancies in inventory and systems have been understood and corrected. To the extent you are pro-active and take charge (if you don’t lead the investigation, a pharmacy inspector will), you will improve your chances of a positive and quick resolution. I would be remiss not to add that you will need legal counsel to guide you through the process.

Medical board complaints

The medical board investigates complaints asserting violations of state law. Most often, complaints assert one or more violations of the standard of care, inappropriate prescribing, inappropriate relationships with patients, physician impairment, and/or criminal activity.

How will I learn that a complaint has been filed against me?

If you are fortunate, you will have learned about the complaint on your own, usually from a colleague, the patient, or a family member of the patient making the complaint. Other times, you will first learn about a complaint when you receive a letter from the medical board, asking you to provide a written explanation. When you learn about the complaint either way, it may be a blessing in disguise, because you have a small amount of time to collect your thoughts, consult a lawyer, and generally prepare yourself to participate in the board’s investigation, which is something you will want and need to do.

If you are unfortunate, however, you will learn about the complaint when you receive a telephone call from the board’s investigator, or worse, an in person surprise visit by the board’s investigator. These surprise calls and visits are most uncomfortable for the physician, they seldom go well, and, in my experience, it means that the medical board believes the complaint is of a more serious type, and that certain desired evidence may best be gained by surprise.

What should I do if I receive a surprise call or visit from a medical board investigator?

I advise my clients to be cooperative, but always decline a surprise interview, and never sign anything without your lawyer’s approval. Instead, request that the interview be scheduled in the next five business days, and offer a time or two. This will usually be adequate for the investigator. If the investigator persists, explain that your calendar cannot accommodate a spontaneous interview and that you are uncomfortable under the circumstances. If the investigator still persists, explain that you want to consult your lawyer and, if necessary, call your lawyer in the investigator’s presence.

Do not be seduced

Friendly questions, or a “few simple questions,” will lead to progressively more difficult questions. Although the investigator is entitled to investigate, and you will want to cooperate with the medical board’s investigation to protect your license and ability to practice, the bottom line is that no physician, and no lawyer, is so skilled and knowledgeable that he/she is prepared for a surprise interview by a skilled investigator. Only the investigator is prepared in that situation, while you are not.

For Pharmacists: Three medication errors could mean probation and loss of PIC

It is well accepted that dispensing or medication errors occur with some regularity in the practice of pharmacy. While most dispensing errors are never reported to the Board of Pharmacy, once they are, there are consequences for the dispensing pharmacist. For a first and second reported dispensing error, the dispensing pharmacist is at risk of professional discipline by the Board of Pharmacy, most likely a reprimand, and a fine ranging from $1,000 to $5,000.

During one recent case, however, it was revealed to me that the Board of Pharmacy is of the view that for a third reported dispensing error, the presumptive sanction is a fine, plus five-years of probation, and loss of pharmacist-in-charge (PIC) privileges. This is true even when pharmacy workload is a factor, and the prescription involves a look-alike or sound-alike drug.

What you need to know

You need to know that the Board of Pharmacy is imposing discipline upon pharmacists for dispensing errors even though pharmacists know, and the literature establishes, that dispensing errors cannot be fully prevented. For example, according to one study cited by the Institute of Medicine’s 2007 report, 1.7 percent of new and refill prescriptions are dispensed in error:

This more recent, large-scale study of both new prescriptions and prescription refills found an error rate of 1.7 percent (Flynn, et al., 2003). This dispensing error rate translates to approximately 4 errors per 250 prescriptions per pharmacy per day, or an estimated 51.5 million errors during the filling of 3 billion prescriptions each year. One study of medication errors at Medco Health Solutions, Inc., a large mail order pharmacy, carried out by Medco employees, found a dispensing error rate of 0.075 percent—16 dispensing errors among 21,252 prescriptions (Teagarden, et al., 2005).

Preventing Medication Errors: Quality Chasm Series (2007). Retrieved from: http://books.nap.edu/openbook.php?record_id=11623&page=113.

Applying the above error rate of 1.7% to a pharmacy filling 1,500 prescriptions per week indicates that 25 dispensing errors occur each week in that pharmacy. Dispensing errors are not, however, fully preventable, due to what has been described by Stuart R. Levine, et al., as a “latent failure” in the practice of pharmacy:

“Medication errors rarely occur from the failure of a single element or because of mistakes from a single practitioner. Rather medication errors are the result of the combined effects of ‚Äòlatent failures’ in the system and ‚Äòactive failures’ by individuals. Latent failures are weaknesses in the structure of the organization, * * * . By themselves, latent failures are often subtle and may cause no problems. Their consequences are hidden, becoming apparent only when they occur in proper sequence and are combined with active failures of individuals to penetrate or bypass the system’s safety nets. Many of the latent and active failures that were at the root of medication errors are not apparent until a root cause analysis is performed. [Footnote omitted] For this reason, providing an optimal level medication safety requires both recognition and correction of latent failures in the system. * * * . It is unrealistic to expect absolute perfection or error free performance from any person. * * * .”

Stuart R. Levine, et al., Guidelines for Preventing Mediation Errors in Pediatrics, p. 427.