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The Perils of Prescribing Medication and the Goldilocks Principle: Defending Related Claims of Malpractice
Volume 86, No. 4

Peter M. Durney

Peter M. Durney
Peter M. Durney is an AV® Preeminent Rated™ attorney and Managing Partner at Cornell & Gollub in Boston, and has been involved in high stakes litigation for years. Peter has represented more than one hundred domestic and foreign corporations – including multiple Fortune 500 companies and Austrian, British, Chinese, French, German, Italian, Irish, Japanese, Korean, and Swiss corporations – in the state and federal courts in New England and elsewhere in the U.S. His broad litigation experience and reported decisions encompass malpractice, products liability, medical device, pharmaceutical, automotive, marine and commercial litigation, as well as appeals. He has directed complex litigation running the gamut from heart tissue transplants and computer software to biotech financing and sophisticated electronic motor vehicle systems. Peter was named Lawyer of the Year by the MA Defense Lawyers Association in 2018 and is a long-standing member of the IADC.

Harrison L. Lebov

Harrison L. Lebov
Harrison L. Lebov is an associate at the law firm Cornell & Gollub in Boston, Massachusetts, and is licensed to practice in Massachusetts and Connecticut. He is the former Lead Blog Editor on the Journal of High Technology Law at Suffolk University Law School, where he graduated cum laude with distinction in the Legal Technology and Innovation concentration. Mr. Lebov now focuses his litigation defense practice in the areas of product liability, professional liability, and general negligence.

ADVANCES in medical science and pharmaceutical engineering in the United States have given rise to an increasing number of claims of abuse related to the prescription of medication. Regulatory and public scrutiny of prescribing practices have increased,11 See Ctrs. for Disease Control and Prevention, U.S. Opioid Prescribing Rate Maps, available at https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html (last updated Oct. 3, 2018) (noting “a steady increase in the overall national opioid prescribing rate starting in 2006, . . . peak[ing] in 2012 at more than 255 million [prescriptions dispensed] and a prescribing rate of 81.3 prescriptions per 100 persons”). Although “[t]he overall national opioid prescribing rate declined from 2012 to 2017,” as of 2017, “prescribing rates continue to remain very high in certain areas across the country.” Id. However, prescriptiondrug abuse is not limited only to opioids; in fact,“[t]he most common types of prescriptiondrugs abused in 2017 were pain relievers, tranquilizers, stimulants, and sedatives.” See Am. Addiction Ctrs., Alcohol and Drug Abuse Statistics, available at https://americanaddictioncenters.org/rehab-guide/addiction-statistics (last updated June 13, 2019). “In 2017, an estimated 6.0 million Americans aged 12 or older misused psychotherapeutic drugs [including, but not limited to, pain relievers, tranquilizers, stimulants, and sedatives] at least once in the past month, which represents 2.2 percent of the population aged 12 or older.” See Substance Abuse and Mental Health Servs. Admin., Key substance use and mental health indicators in the United States: Results from the 2017 National Survey on Drug Use and Health, HHS Publication No. SMA 18-5068, NSDUH Series H-53, available at https://www.samhsa.gov/data/report/2017-nsduh-annual-national-report (last visited Sept. 15, 2019). as has patient awareness. As a result, medical practitioners authorized to write prescriptions have come to be exposed to liability for claims not only for their having over-prescribed medication, but also for their having under-prescribed medication; that is, having prescribed less than an adequate dose of an otherwise effective medication.22 See Brookes v. Shank, 660 Fed. Appx. 465, 466-467 (6th Cir. 2016) (presenting an instance where a physician working in a correctional institution faced a wrongful death claim from a deceased inmate’s estate after the inmate committed suicide following a cancellation of his gabapentin prescription upon the physician’s good faith belief that the inmate was drug-seeking); Garcia v. Sleeley, Case No. 3:14-CV-01525-JLS-PCL, 2018 WL 3303013, at *10-11 (S.D. Cal. July 5, 2018) (finding that the defendant doctors “were not deliberately indifferent toward Plaintiff’s pain; but instead responded to Plaintiff’s medical needs in a way they saw fit” when faced with allegations that “they ‘under prescribed’ Plaintiff a combination of ‘weak’ pain relieving medications”); Goins v. Pacheco, No. 4:14-4639-RMG, 2016 WL 411011, at *1 (D. S.C. Feb. 2, 2016) (a case where the defendant doctor allegedly “failed to provide [the plaintiff] with the proper medication to treat his mental health condition, either prescribing too much medication or too little medication”). Simultaneously, a rising percentage of such malpractice claims involve troubled individuals exhibiting drug-seeking behavior,33 See Ballard v. NC Dept. of Public Safety, No. 5:13–CV–175–FDW, 2015 WL 5062214, at *3 (W.D.N.C. Aug. 27, 2015) (Inmate brought suit against a correctional facility claiming doctor wrongfully reduced the inmate’s oxycodone dosages before cancelling the prescription altogether. The doctor believed that the inmate was exhibiting “drug-seeking” behavior). or instances of so-called “doctor-shopping” by drug dependent patients.44 See Scoggins v. Floyd Healthcare Management Inc., No. 4:14-CV-00274-HLM-WEJ, 2016 WL 11544774, at *22 n.62 (N.D. Ga. June 10, 2016) (defining “[d]octor shopping [as] traditionally referr[ing] to a patient obtaining controlled substances from multiple healthcare practitioners without the prescribers’ knowledge of the other prescriptions”) (internal quotations omitted) (citations omitted). This patient profile presents a real conundrum for treating physicians. A doctor observing that his or her patient is exhibiting drug-seeking behavior, or has been doctor-shopping, may feel conflicted about how best to effectively treat that patient, or be distracted by the need to remain hyper-alert to steering clear of allegations of over-prescription or under-prescription of medication,55 See Lance P. Longo, et al., Addiction: Part II. Identification and Management of the Drug-Seeking Patient, 61 Am. Fam. Physician 2401-2408 (2000) (recognizing the paradox that is “the desire to relieve pain, anxiety and other discomfort [] weighed against the fear of creating addiction, of being investigated by law enforcement or licensing authorities, and of being ‘scammed’ by the occasional [drug-seeking] patient”). “These competing concerns often leave physicians feeling ambivalent and uncomfortable about prescribing controlled substances, to the detriment of the majority of patients who suffer legitimate illnesses and are often left undertreated or feeling stigmatized.” Id. “Physicians’ concerns about possible legal, regulatory, licensing or other third-party sanctions related to the prescription of controlled substances may contribute significantly to the undertreatment of pain syndromes and anxiety disorders.” Id. both of which theories are currently being used as bases for allegations of medical malpractice.66 See supra note 2 (examples of cases where medical malpractice claims were lodged on the basis of over-prescription and under-prescription of medication).

Where pharmaceuticals are concerned, trial and error may ultimately dictate the best course of treatment. But with different prescription regimens comes risk. How much prescription medication is too much? How much prescription medication is too little? This conundrum fits squarely within what has been colloquially referred to as the “Goldilocks Principle,” taken from the popular children’s story. In essence, the Goldilocks Principle describes the internal tug of war between competing concerns, in an effort to arrive at the best solution for whatever problem one is facing. That sounds innocuous enough. However, where the end of the children’s story finds Goldilocks asleep in Baby Bear’s bed, having evaluated her options before ultimately choosing which bowl of porridge to eat and where to sleep, the issues addressed in this article are anything but lighthearted. The potential consequences for the prescribing physician or nurse accused of malpractice are much more serious than those faced by the Goldilocks story’s young protagonist. In medicine, which all would agree is not a “perfect science,” the best choice is rarely immediately apparent, consequently deciding the proper course is not easy. Therein lie the challenges addressed by this article. In the context of prescription medications, finding the optimal dosage of a medication for each individual  patient77 See Jeffrey K. Aronson, Balanced prescribing – principles and challenges, 74 Br. J. Clin. Pharmacol. 566-572 (2012) (addressing the herculean undertaking of properly prescribing medication, i.e. balanced prescribing – “a process that recommends a medicine appropriate to the patient’s condition and,within the limits created by the uncertainty that attends therapeutic decisions, a dosage regimen that optimizes the balance of benefit to harm”).

The essential steps in achieving [balanced prescribing] are (a) careful attention to the history, examination, and investigation of the patient's condition and drug therapy, (b) accurate diagnosis, (c) detailed attention to prescribing the dosage regimen in the light of the therapeutic goal, (d) careful writing of the prescription and (e) regular monitoring of therapy, including attention to beneficial outcomes, adverse reactions, and patient adherence. The two major requirements in determining the dosage regimen are (1) understanding the pathophysiology of a health problem and matching it to the mechanisms of action of the relevant medicines and (2) assessing the benefit to harm balance of the therapy, although the difficulties in doing this in the individual are great. Id. (emphasis added). See also Parker v. Fidelity Security Life Ins. Co., No. CIV F 06-654 AWI DLB, 2007 WL 2688811, at *3 (E.D. Cal. Sept. 12, 2007) (highlighting the difficulty in properly prescribing medication to a person with mental health problems who “regularly took either too much or too little of his medication, and [] was difficult to keep [] on his prescribed level of medication,” thus compounding the already present difficulties).   mandates an awareness of the balance between over-prescription and under-prescription, along with an appreciation for potential addiction and habituation.88 See Pub. Health Serv., Off. of the Surgeon Gen., U.S. Dep’t of Health, Educ. and Welfare, Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service, 351 (1964), available at https://profiles.nlm.nih.gov/ps/access/nnbbnk.pdf (explaining the difference between drug addiction and drug habituation).

Drug addiction is a state of periodic or chronic intoxication produced by the repeated consumption of a drug []. Its characteristics include: (1) an overpowering desire or need (compulsion) to continue taking the drug and to obtain it by any means; (2) a tendency to increase the dose; [and] (3) a psychic (psychological) and generally a physical dependence on the effects of the drug . . .

Drug habituation (habit) is a condition resulting from repeated consumption of a drug. Its characteristics include: (1) a desire (but not a compulsion) to continue taking the drug from the sense of improved well-being which it engenders; (2) little or no tendency to increase the dose; [and](3) some degree ofphysic dependence on the effect of the drug, but absence of physical dependence and hence of an abstinence syndrome . . . Id. 

The Drug Enforcement Administration (“DEA”) recognizes the need to guard the general public against the perils of prescription drug abuse, but also is not so naive as to ignore the fact that drug-seeking patients often try to scam their way into excess amounts of medication.99 See U.S. Dep’t of Just., Drug Enf’t Admin., Diversion Control Div., Don’t Be Scammed by a Drug Abuser,1:1 (Dec. 1999), available at https://www.deadiversion.usdoj.gov/pubs/brochures/drugabuser.htm (last visited Sept. 14, 2019) (discussing how to recognize drug-seeking patients, common characteristics of drug-seeking patients, modus operandi often used by drug-seeking patients, and how to deal with drug-seeking patients). The DEA has alerted medical providers to their “professional responsibility to prescribe controlled substances appropriately, guarding against abuse while ensuring that … patients have medication available when they need it.”1010 See id. (advising prescribers to be diligent in their prescription writing practices). With that said, the vast differences in people’s physiologies and psychologies1111 See Jeffrey O’Connell and Andrew S. Boutros, Treating Medical Malpractice Claims under a Variant of the Business Judgment Rule, 77 Notre Dame L. Rev. 373, 376 (2002) (noting “the incredibly intricate nature of the human body”). “The human body is composed of almost infinitely elaborate interlocking parts that baffle nearly all who study them.” Id. “[T]he many mysteries of disease and illness and the human body’s response to them, are still in many regards unclear.” Id. at 402. make finding an appropriate chemical equilibrium alarmingly difficult. Within that framework, this article addresses a much more serious challenge than sensing whether porridge is too hot or too cold, or which bed suits one best. Potential adverse outcomes resulting from claims against prescribing physicians run the gamut from significant jury verdicts to a career-ending loss of license.

I. Background

In order to more fully understand the issues practitioners face in this area, and to appreciate the potential legal exposure to the medical community, it is worth revisiting the underpinnings of any medical malpractice claim. “[M]odern tort law related to medical negligence claims has evolved from the principles of English common law, modified and changed by numerous court decisions and legislative statutes that vary from one state to another.”1212 See B. Sonny Bal, An Introduction to Medical Malpractice in the United States, 467 Clin. Orthop. Relat. Res. 339, 339-347 (2008).  Medical malpractice is generally understood as a legal cause of action occurring when the care and treatment administered by a doctor or medical care provider falls below an applicable standard of care; meaning that the care rendered was not in conformity with the knowledge and skill of other similarly-situated doctors under like circumstances.1313 See Alef v. Alta Bates Hospital, 5 Cal.App.4th 208, 215 (1992) (defining the standard of care in medical malpractice cases as requiring doctors to “exercise that reasonable degree of skill, knowledge and care ordinarily possessed and exercised by members of their profession under similar circumstances”). See also infra note 14. Although this definition varies from jurisdiction to jurisdiction, and the applicable standard of care may as well, the concept giving rise to potential liability remains essentially the same.1414 See, for example, Pa.R.C.P. No. 1042.3 (requiring under Pennsylvania law that for an “action based upon an allegation that a licensed professional deviated from an acceptable professional standard,” that “the care, skill or knowledge exercised or exhibited in the treatment, practice or work that is the subject of the complaint, fell outside acceptable professional standards”); Sitts v. United States, 811 F.2d 736, 739 (2nd Cir. 1987) (requiring under New York law that a physician “possess at least the degree of knowledge and skill possessed by the average member of the medical profession in the community in which he practices, to exercise ordinary and reasonable care in the application of that professional knowledge and skill, and to use his best judgment in the application of his knowledge and skill”); Klisch v. Meritcare Medical Group, Inc., 134 F.3d 1356, 1360 (8th Cir. 1998) (requiring under Minnesota law that a physician be “compared to those with the skill and knowledge ordinarily possessed by those within the same specialty who are similarly situated,” meaning those physicians working in a similar area and “having the same technology available to them”).

With respect to the standard of care against which a physician or nurse’s care will be measured, most states have forgone the antiquated “strict locality” standard for the “similar locality” standard,1515 1 Am. Law Med. Malp. § 3:5 (2019) (recognizing the trend towards abandoning the “strict locality” standard in favor of a “national” standard). The strict locality rule is generally understood to mean “the standard of care exercised by physicians in a defendant’s own community or locality,” which is “presumed to be less adequately informed and equipped” than more populous, less rural areas. Id. The “similar locality” standard, although a “slight improvement” over the “strict locality” standard, is still faced with problems similar to its predecessor; namely, “a low standard of care in some of the smaller communities,” and “the difficulty … in defining a ‘similar’ locality.” Id. or have joined in the modern trend of adopting a standard of care more closely resembling the medical community as a whole, rather than the medical community where the plaintiff received treatment.1616 See generally Shilkret v. Annapolis Emergency Hospital Ass’n, 349 A.2d 245 (Md. 1975) (a leading case that endorses the national standard of care overstandards of care guided by locality). The court in Shilkret opined that “[s]ince the medical profession itself recognizes national standards for specialists that are not determined by geography, the law should follow suit.” Id. at 251. Within this construct, medication errors are a common factual basis upon which plaintiffs often base their medical malpractice claims.1717 Emma Wallace, et al., The epidemiology of malpractice claims in primary care: a systematic review, 3 BMJ Open e002929 (2013) (quantifying the frequency with which medical malpractice claims are based on medication error). “[T]he second commonest medical misadventure cited in malpractice claims was medication error ranging from 5.6% to 20% across included studies. A recent UK review reported that prescribing error, inappropriate medication, drug administration errors, dispensing errors and adverse drug reactions are the commonest processes which result in a medication error.” Id. (internal citations omitted). A plaintiff alleges, in substance, that a provider’s decision to prescribe a certain medication or combined medications in specific quantities and dosages violated the applicable standard of care (i.e. the prescriber’s decision fell below a jurisdictionally-determined acceptable standard of care).1818 See In re Miller, 186 Vt. 505, 511 (Vt. 2009) (finding medication error in that the defendant doctor’s “treatment of the patients in his private practice . . . did not meet the standards of care required by the [Medical Practice] Board’s policy for the use of controlled substances”) (internal quotations omitted). Among the many improprieties with which the defendant doctor in Miller operated his private medical practice, the defendant doctor “routinely wrote narcotics prescriptions for patients whom he did not regularly examine; wrote multiple narcotics prescriptions for patients weeks in advance, [and] in quantities that exceeded the amount to be taken.” Id. See also Aquino v. United States, No. C04-2008L, 2005 WL 1288002, at * 5 (W.D. Wash. May 27, 2005) (providing one example of an alleged violation of the standard of care based in part on the over-prescription of medication). In Aquino, the plaintiff patient argued that the defendant doctor “violated the standard of care of a reasonably prudent psychiatrist in his care and treatment of [the plaintiff patient] . . . not only for prescribing Vicodin and Valium without informed consent, but also in over-prescribing.” Id.

Regarding the burden of proof required in order to succeed in a claim for medical malpractice, whether based upon medication error or some other alleged malfeasance, “the plaintiff is required to prove by a preponderance of evidence, as in any negligence action, that the defendant owed the plaintiff a duty to protect against the risk involved (or the applicable standard of care), and the injury was caused by the breach.”1919 See Benefield v. Sibley, 988 So. 2d 279, 286 (2nd Cir. 2008) (presenting generally the elements of a professional negligence claim).  Just as the professional standard of care may vary slightly from jurisdiction to jurisdiction, so too do the requirements for maintaining a medical malpractice claim.2020 See Bal, supra note 12 (recognizing the subtle differences in medical malpractice law from state to state).

In the United States, medical malpractice law is under the authority of the individual states; theframework and rules that govern it have been established through decisions of lawsuits filed in state courts. Thus, state law governing medical malpractice can vary across different jurisdictions in the United States, although the principles are similar. In addition, during the last 30 years, statutes passed by states’ legislatures have further influenced the governing principles of medical malpractice law. Thus medical malpractice law in the United States is based on common law, modified by state legislative actions that vary from state to state. Id. Uniformly, however, medical malpractice claims generally still retain the essential elements of duty, breach, causation, and damages.2121 See Smith v. Providence Health & Services-Oregon, 361 Or. 456, 460 (Or. 2017) (holding that “[i]n a professional negligence claim, a plaintiff must allege and prove the following: (1) a duty that runs from the defendant to the plaintiff; (2) a breach of that duty; (3) a resulting harm to the plaintiff measurable in damages; and (4) causation”) (internal quotations omitted); Delta Regional Medical Center v. Taylor, 112 So. 3d 11, 24 (Miss. App. Ct. 2012) (noting the “essential elements” of a medical malpractice claim: “(1) the existence of a duty on the part of a physician to conform to the specific standard of conduct, (2) the applicable standard of care, (3) the physician’s failure to perform to that standard, (4) that the breach of the duty by the physician was the proximate cause of the plaintiff’s injury, and (5) that damages to the plaintiff resulted”); Lively v. Kilgore, 51 So. 3d 1045, 1047-1048 (Ala. Civ. App. 2010) (citing the Alabama Supreme Court that “[i]n a legal malpractice case a plaintiff must prove, basically, the same [elements] that must be proven in an ordinary negligence suit. Thus, the elements [a plaintiff] must prove in order to support his legal malpractice claim are a duty, a breach of that duty, an injury, that the breach was the proximate cause of the injury, and damages”) (internal citations omitted). If the plaintiff is not able to prove each element by a preponderance of the evidence, the plaintiff may not recover damages from the defendant.2222 See Satterwhite v. Reilly, 817 So. 2d 407, 410 (La. Ct. App. 2002) (providing a concise recitation of the rule denying plaintiff recovery in a medical negligence case if he or she is not able to prove every essential element by a preponderance of evidence). “If the plaintiff fails to prove any one element by preponderance of the evidence, the defendant is not liable.” Id.

II. Important Trends in Malpractice Litigation

Medical malpractice lawsuits have long played a significant role in American society: in holding caregivers accountable for their culpable acts or omissions,2323 See Bal, supra note 12 (proffering that “[t]he concept of holding a physician accountable for medical malpractice is grounded in ancient law”).  as a deterrent against poor medical practices, and in compensating individuals for damages caused by caregiver negligence.2424 See Frank A. Sloan and Stephen S. van Wert, Cost and Compensation of Injuries in Medical Malpractice, 54 Law and Contemp. Probs. 131, 168 (1991)(recognizing that“[t]he primary functions of the tort system in resolving medical malpractice claims are to deter injuries and to compensate victims”). This source also finds that, at the time of its publishing, “compensation tends to fall short of the costs of injuries . . .” and “[f]rom the perspective of deterrence, therefore, compensation is inadequate on average.” Id. This source nonetheless acknowledges that the aim of a medical malpractice suit is to compensate tort victims, even if they ultimately determined that tort victims are, in the aggregate, “undercompensated.” Id. See also O’Connell and Boutros, supra note 11, at 375-376 (noting that “the two goals of the current tort system as applied to medical malpractice [are] compensation and deterrence”). This source also finds that “the tort system is incapable of achieving either of these goals,” but nonetheless acknowledges that these are in fact the goals of medical malpractice cases. Id. at 376.  Because “the outcome in a given medical malpractice case may be unpredictable,” and because plaintiffs may be “overly optimistic about their chances for obtaining a high verdict award,” the courts have seen a proliferation of nuisance suits.2525 See Sloan and van Wert, supra note 24 (explaining how the unpredictability of verdicts in medical malpractice suits leave open the potential for nuisance claims). Even plaintiffs operating in good faith may make unreasonably high demands given that “[t]here are no guidelines for quantifying pain and suffering and other kinds of noneconomic loss.” Id. In response, legislatures across the country have attempted to reign in this problem by mandating that parties engage in various forms of alternative dispute resolution (“ADR”).2626 See Am. Med. Ass’n, State Law Chart II: Liability Reforms (2017), available at https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/premium/arc/state-laws-chart-2_0.pdf (last visited Sept. 15, 2019) (detailing the various forms of ADR available throughout all fifty states). Many legislatures also have implemented some type of a pre-trial screening panel for medical malpractice cases,2727 See id.(identifying which states require a medical malpractice plaintiff to first pass through a pre-trial screening panel before continuing to litigate his or her claim). requiring plaintiffs first to meet a threshold level of credible proof of wrongdoing before being permitted to litigate their claims without posting a bond.2828 See Heather Morton, Medical Liability/Malpractice ADR and Screening Panels Statutes, Nat’l Conf. of St. Legislatures (May 20, 2014), available at http://www.ncsl.org/research/financial-services-and-commerce/medical-liability-malpractice-adr-and-screening-panels-statutes.aspx (last visited Sept. 15, 2019) (defining a pre-trial screening process).

Unfortunately, some of these tort-reform measures are more appealing in theory than in practice. For example, while worth fighting in many circumstances, success at the tribunal level is often a pyrrhic victory. Even if a defendant in a jurisdiction which mandates pre-trial screening is able to keep a plaintiff from clearing that first hurdle, in all probability the defendant medical care provider will still face an uphill battle in an arena where medical decisions are inevitably viewed through the lens of hindsight.2929 See Hal Richard Arkes, The Consequences of the Hindsight bias in Medical Decision Making, 22 Association for Psychological Science 356-360 (2013) (defining hindsight bias in the context of medical malpractice cases). Finders of fact will be told about the outcome of the prescription regimen (i.e. that the prescription regimen was unsuccessful or even harmful).3030 See K. Henriksen and H. Kaplan, Hindsight bias, outcome knowledge and adaptive learning, 12(ii) BMJ Quality & Safety 46-50 (2003) (explaining outcome knowledge and how it can bias an analysis of a doctor’s practice of medicine).

The prescribing physician or nurse, on the other hand, could not have predicted the ultimate outcome at the time he or she prescribed the medication. Consequently, a fact finder, deliberating with the benefit of hindsight, may pass judgment on a medical provider’s prescription-writing decisions without due “consideration [for] the level of difficulty required to make the initial evaluation decision,”3131 See Amanda Beltrani, Hindsight Bias in Clinical Decision Marking, CUNY Academic Works, at 24 (2017), available at https://academicworks.cuny.edu/jj_etds/3/ (recognizing how hindsight bias and outcome knowledge can cause a finder of fact to wane his or her consideration for the difficulty of the doctor’s job in making prescribing decisions). or with an undeveloped appreciation for the fact that the doctor was diligent in his or her assessments and was operating in good faith.3232 See O’Connell and Boutros, supra note 11, at 389-393; Beltrani, supra note 31, at90 (offering the opinion that courts should adopt a medical-equivalent of the business judgment rule, whereby courts would inquire into the “good faith, independence and thoroughness” of a doctor’s decisions). For context, the business judgment rule provides that:

if in the course of management, officers and directors arrive at a decision that is within their  corporation’s authority, and for which there is a rational basis, and they act in good faith, as the result of their independent discretion and judgment, and uninfluenced by any consideration other than what they honestly believe to be in the best interests of the corporation, then a court will not second guess the judgment of the officers and/or directors; nor will a court enjoin or set aside [a] transaction or . . . surcharge the directors [and officers] for any resulting loss. See id. at 385 (internal quotations omitted). In making the argument that the medical profession should have its own version of the business judgment rule, this source discusses in detail the seminal case of Currie v. United States, 836 F.2d 209 (4th Cir. 1087). In Currie, the court was tasked with reviewing a psychotherapist’s decision whether or not to involuntarily commit a patient. In doing so, the court adopted a “psychotherapist judgement rule,” and enumerated several factors toconsider when reviewing a doctor’s conduct:

competence and training of the reviewing psychotherapists, whether the relevant documents and evidence were adequately, promptly and independently reviewed, whether the advice or opinion of another therapist was obtained, whether the evaluation was made in light of the proper legal standards for commitment, and whether other evidence of good faith exists. See 644 F. Supp. 1074, 1083 (M.D.N.C. 1986), aff’d, 836 F.2d 209 (4th Cir. 1987).

III. The Fundamental Problem vs. The Standard of Care

As a matter of sound public policy, the continued development of logical, reasonable standards within which physicians may be expected to conduct themselves has significant merit. While the predictability of outcomes in the medical profession is almost always uncertain, practice guidelines help define what should be considered standard practice, as well as what may be considered deviations from that standard of care. In regard to prescription medicines, however, the standard of care has not been refined to the point where it takes fully into consideration the realities of potential gaming of the system by patients with substance abuse problems.3333 See Don’t Be Scammed by a Drug Abuser, supra note 9 (recognizing the potential for abuse of the system by drug-seeking individuals).  Such patients put prescribers in the unenviable position of having to make a Hobson’s choice between opening themselves up to criticism for “over-prescribing” medications to patients who are feeding addictions rather than treating maladies, or “under-prescribing” medications to patients who objectively appear to be drug-seeking, but subjectively claim deprivation of life-altering medication.

A. Two Case Studies

Because either over-prescription or under-prescription of medication can serve as a basis for a claim of medical malpractice, legal practitioners should urge fact finders to understand and appreciate the difficulty inherent in finding a prescription regimen that best fits the patient’s medical needs. Judges and jurors should be asked to give heightened deference to medical professionals’ thoughtful, prescription-writing decisions, if made in good faith.3434 See generally O’Connell and Boutros, supra note 11 (emphasizing the premise of this article that the breach of the duty of care in medical malpractice claimsshould be evaluated using what would be the medical-equivalent of the business judgment rule). In the inverse, conduct determined to have been in bad faith clearly would run counter to the Hippocratic Oath, with associated concomitant exposure to the most serious of consequences. 

Consider these two cases:

In Weaver v. Lentz, a physician was found liable for the wrongful death of a plaintiff.3535 See Weaver v. Lentz, 348 S.C. 672, 676 (S.C. 2002). The  court recited the following facts:

Weaver initially visited Dr. Lentz, complaining primarily of neck pain and headaches resulting from an auto accident. Dr. Lentz saw Weaver on a regular basis during the ensuing years and tried several drug combinations to manage the pain with overlapping prescriptions and multiple substitutions. Weaver frequently complained of neck muscle pain, muscle spasms, headaches, insomnia, depression, and anxiety. He was hospitalized multiple times for physical problems where overdose or addiction concerns were noted. In December 1993, Weaver was hospitalized for psychiatric evaluation and treatment for addiction to prescription pain medications and was diagnosed with severe major depression and borderline personality disorder. On February 17, 1994, Weaver died from an overdose of Darvocet,3636 See Food and Drug Admin., Medication Guide: Darvocet-N 50 and Darvocet-N 100 (Sept. 2009), available at https://www.fda.gov/media/78044/download (last visited July 3, 2019) (providing a description of the prescription drug, Darvocet). Darvocet-N is a prescription medicine that contains two medicines: propoxyphene and acetaminophen. Id. Darvocet-N is used to relieve mild to moderate pain. Id. Darvocet-N is a federally controlled substance (C-IV) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs. Id. a drug which had been prescribed by Dr. Lentz. The parties dispute whether the death was an accident or suicide.3737 See Weaver, 348 S.C. at 676.
. . .
Weaver's treating psychiatrist noted in his discharge summary from the 1993 hospitalization that Weaver was ‘severely impaired with psychotic depression and severe borderline personality disorder,’ and opined that Weaver was ‘completely and entirely disabled’ and would not be able to return to active work. When asked what effect these conclusions may have upon his opinion of Weaver's future employability, [a vocational rehabilitation expert, Dr. William] Stewart testified that if the findings were accepted as correct, Weaver would not be employable.3838 See id. at 679.

The basic facts of this case are not entirely uncommon. Many people who begin taking opioids or painkillers to treat acute pain, such as post-surgical pain, remain on pain relief medication for an extended duration.3939 See National Academies of Sciences, Engineering, and Medicine, Pain management and the opioid epidemic: Balancing societal and individual benefits and risks of prescription opioid use, The Nat’l Academies Press (2017), available at https://www.ncbi.nlm.nih.gov/pubmed/29023083 (discussing in detail the “FDA’s development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring”).

While the FDA-approved indications for use and labeling of opioids specify for whom and under what conditions the medications are intended to be used, prescribing and patient use patterns may differ from those envisioned at the time of approval. For instance, many opioid medications, such as IR [immediate-release] products, are intended to be used to treat acute pain, such aspostsurgical pain, over a short duration. However, a large proportion of patients continue to be treated with IR opioids farbeyond the expected duration of healing, aphenomenon that could indicate failure to heal from an injury or surgery, progression or persistence of pain to a chronic state, opioid dependence, onset of OUD [Opioid Use Disorder], poor product labeling, or something else entirely. Id. at 194 (internal citations omitted). Unfortunately, there is no simple answer for this problem,4040 Personalized Med. Coal., The Case for Personalized Medicine 11 (4th ed. 2014) (noting that there is not a one-size-fits-all solution to prescription medication, as “[p]atients can respond differently to the same medicine”). See also O’Connell and Boutros, supra note 11, at 402 (noting that “the many mysteries of disease and illness and the human body’s response to them, are still in many regards unclear”).  no  panacea for this often-seen paradigm. As sad and disturbing an outcome as the Weaver case presents, the facts do not necessarily lead one to conclude that there must have been a deviation from the standard of care resulting in the eventual loss of life. Indeed, dedicated researchers are still investigating the “causal pathways from the onset of pain to opioid exposure and to potential negative consequences.”4141 See Pain management and the opioid epidemic, supra note 39 (highlighting the difficulty in treating patients with opioids given the entanglement between “misuse, drug seeking related to undertreatment of pain, OUD [Opioid Use Disorder], and overdose,” id. at 189 (citations omitted)). 

We contrast the facts in Weaver with the facts in Padilla v. Minnesota State Board of Medical Examiners.4242 See generally Padilla v. Minnesota State Board of Medical Examiners, 382 N.W.2d 876 (Minn. Ct. App. 1986).  Padilla presents one of the more egregious examples of “unethical, deleterious, [and] unprofessional conduct” in a medical malpractice case.4343 See id.(noting the court’s revocation of a doctor’s license to practice medicine for engaging in sexual conduct with patients in exchange for providing prescriptions for medication). See also Michael R. Flaherty, Improper or immoral sexually related conduct toward patient as ground for disciplinary action against physician, dentist, or other licensed healer, 59 A.L.R. 4th 1104 (1988) (using the Padilla case as the premiere example of how a doctor should be subject to discipline for having sexual intercourse with patients in exchange for drugs). In Padilla, credible evidence was found to exist that the treating physician would regularly engage in quid pro quos of a sexual nature with patients and had made multiple sexual advances on patients.4444 See Padilla, 382 N.W.2d at 878-882. Among the various indefensible infractions noted by the court, any one of which standing alone might have been enough to support revocation of a medical license, the physician was found to have traded prescriptions for benzodiazepines and opioids for sexual favors, for having administered unnecessary pelvic examinations to female patients, and for having kissed, hugged, groped and propositioned various other female patients.4545 See id

The takeaway from these two cases is that to a jury, the line not to be crossed may not always be a bright one. Clearly, the cases present strikingly different fact patterns, yet both resulted in a verdict against the defendant doctor, an outcome which may not have seemed fair in the first case. The patient in Weaver had been diagnosed with psychotic depression and severe borderline personality disorder. He was suicidal; said to be unemployable; and required psychiatric hospitalization on more than one occasion. He was reportedly dealing with opioid addiction or habituation stemming from injuries caused by an automobile accident that left residual neck muscle pain, muscle spasms, headaches, insomnia, depression, and anxiety.4646 See Weaver, 348 S.C. at 676-679 (recounting the extent of plaintiff’s injuries and disabilities). Given those complexities, considerable deference could have been, and perhaps should have been, accorded to the treating physician for his medical judgment.4747 Arguing that the “benefit of the doubt” should be extended to Dr. Lentz and his similarly-situated contemporaries acting with diligence and in good faith is really just a colloquial way of arguing that the breach of the duty of care should be measured against a standard more closely resembling a variation of the business judgment rule. See generally O’Connell and Boutros, supra note 11. After all, in evaluating the case, the parties, their lawyers, the judge, the jury, and the medical experts all had the benefit of hindsight.

B. Hindsight and Outcome Biases

Jurors often place themselves in the role of the “Monday morning quarterback” despite jury instructions defining the standard of care, and the reality that medical professionals cannot gaze into a crystal ball or, to stick with the analogy, watch a replay, for help in predicting possible outcomes with any given patient. While jurors may decide that a different play should have been called, their view often has been impacted by knowledge of the outcome, and by their desire to retrospectively evaluate the practitioners’ decision-making. They should not be permitted to ignore the reality that the ultimate prognosis may have been unclear to the caregiver deciding medication issues in real time.

“Hindsight bias is the tendency for people with outcome knowledge to exaggerate the extent to which they would have predicted the event beforehand, while outcome bias refers to the influence of outcome knowledge upon evaluations of decision quality.”4848 See Henriksen and Kaplan, supra note 30 (defining and distinguishing hindsight bias from outcome bias). In medical malpractice cases, “[a]n adverse event has already taken place, and jurors are asked to consider whether a physician has met the standard of care in his or her treatment of the patient.”4949 See Arkes, supra note 29, at 358 (relating hindsight bias to the context of medical malpractice). This unavoidably retrospective analysis could be implicitly prejudicial since “[m]alpractice verdicts are always rendered from the perspective of hindsight.”5050 See id. (explaining generally the mechanics of a medical malpractice lawsuit).

Studies have shown that “outcome information consistently influenced evaluations of decision quality [and] the competence of the decision maker.”5151 See Henriksen and Kaplan, supra note 30 (showing that outcome information unduly guides decision makers in the decision-making process). In the context of medical malpractice and medication error, this means that medical professionals are not necessarily being evaluated on their prescribing decisions, but rather on whether a prescription regimen “worked” for a particular patient at a particular time. This outcome bias is not necessarily intentional, or even conscious. In fact, some studies have shown that subjects responsible for the evaluation, including jurors, understand that “they should not consider outcomes in making the evaluations, [but they] did in fact do so.”5252 See id. (presenting the unavoidable bias that knowledge of the outcome of a process has on the decision maker’s evaluation of the process itself). “[M]any decision makers have difficulty improving their decision- making processes because they irrationally judge everything based on outcomes.” Id. It logically follows that “the strong impact of an outcome can … bias our thinking about the processes that led to that outcome.”5353 See id. (describing the impact of outcome bias on individuals’ assessments of processes as “unfortunate,” but nonetheless acknowledging the reality of the existence of the bias).  

To avoid such bias, jurors need to be brought back to the Goldilocks Principle. They need to understand the difficulty in predicting how a certain medication or a combination of medications in specific dosages may affect people with differing physiologies and psychologies.5454 See Personalized Med. Coal., supra note 40, at 9 (providing scientific reasoning as to why some medicines work for some people but not for others).

Many patients do not benefit from the first drug they are offered in treatment. For example, 38 percent ofdepression patients, 50 percent of arthritis patients, 40 percent of asthma patients, and 43 percent of diabeticpatients willnot respond to initial treatment. Studies have linked these differences in response to the differences in genes that code for drug-metabolizing enzymes, drug transporters, or drug targets. The majority of patients, for example, have at least one DNA-based variation in the enzymes that metabolize half of the most commonly prescribed medicines. Id.(internal citations omitted). See also O’Connell and Boutros, supra note 11, at 402 (noting that “the many mysteries of disease and illness and the human body’s response to them, are still in many regards unclear”). They need to be reminded that, as finders of fact in a lawsuit, they have the benefit of hindsight -- knowledge of the outcome -- in evaluating the prescriber’s processes and medical decisions. They need to be asked to commit at the outset of a trial to evaluating the case based on the doctor’s or nurse’s processes, and good faith, rather than on the patient’s outcome. To do otherwise would be to sidestep a proper negligence-causation analysis and to unduly focus on the patient’s damages. “[W]hen provided with information regarding the outcome of an event, individuals may simplify, trivialize, and retrospectively criticize the judgments that others have made without acknowledging the difficulty involved in the decision-making process.”5555 See Beltrani, supra note 31 at 6 (emphasis added) (minimizing prescriber’s difficulties when afforded the benefit of hindsight).

Ironically, hindsight often may be the only definitive way of knowing what prescription regimen was “just right,” considering that much of prescribing unavoidably involves some trial – and – error.5656 See Personalized Med. Coal., supra note 40, at 9-15 (noting that “[m]any patients do not benefit from the first drug they are offered in treatment,” which is reflective of how common trial-and-error dosing has come to be).

Unfortunately, experimenting with different medicines and dosages creates expectations and risk. Any particular patient may conclude that he or she has been overprescribed or under-prescribed medication. He or she may find that the prescription regimens were ineffective, worsened their symptoms, or caused new, unanticipated side effects.

C. Pre-Trial Screening Panels

Fortunately for practitioners in some states, legislators have become attuned to hindsight bias, outcome bias, and other problems inherent in medical malpractice litigation, and have responded by establishing some form of a pre-trial screening panel to allow for, among other issues, the early discussion of such realities in the context of alleged deviations from the standard of care.5757 See State Law Chart II: Liability Reforms, supra note 26 (detailing the pre-trial screening process, if any, in all fifty states, before being able to litigate a medical malpractice claim). 

“Pre-trial screening panels, like most alternative dispute resolution mechanisms, operate to encourage parties to settle meritorious claims and to deter or eliminate ‘nuisance’ suits.”5858 See Jerome Harleston, Medical Malpractice Pretrial Screening Panels, Conn. Off. of Legis. Res. (2003-R-0401), available at https://www.cga.ct.gov/2003/orldata/ins/rpt/2003-R-0401.htm (last visited Sept. 15, 2019) (summarizing the purpose for conducting a pre-trial screening process). The format for the pre-trial screening process varies from state to state, as does the composition of the pre-trial screening panel.5959 See State Law Chart II: Liability Reforms, supra note 26 (recognizing a great variance from state to state in the procedures and construction of pre-trial screening panels). Generally speaking, a pre-trial screening panel is comprised of some combination of medical professionals, attorneys, judges, hospital administrators and lay people, typically grouped into panels of three to five persons, and sometimes with a non-voting chairperson to “referee.”6060 See id. (elaborating on the varied composition of pre-trial screening panels across different jurisdictions).

Typically, the panel will conduct some form of a modified trial, sometimes with the introduction of evidence, witnesses and expert witnesses, which usually concludes with the panel voting and rendering some sort of finding about the merits of the claims, the potential liability of the defendant, and whether in the opinion of the panel, the defendant met or deviated from the standard of care.6161 See id. (explaining the procedures by which different panels render opinions at the conclusion of the process). Depending on the jurisdiction, the report from the panel’s majority (and sometimes a report from the dissenting minority, if any) may or may not be introduced as evidence in the later formal proceeding. Panel members may or may not be permitted to be called to testify as expert witnesses.6262 See id. (examining the application of the panel’s report(s) and discussing whether panel members may be called as expert witnesses at any later trial, if the matter proceeds to trial). States that employ some form of a pre-trial screening typically “require an affidavit or certificate of merit from a medical expert for a medical liability or malpractice case to move forward and proceed through the judicial system.”6363 See Morton, supra note 28 (creating a barrier for a medical malpractice claimantto first surpass before being permitted to continue with his or her litigation).

As of 2014, twenty-seven (27) states had adopted “specific provisions providing for alternative dispute resolution [“ADR”] (arbitration, mediation or settlement conferences) in medical liability or malpractice cases,” but only seventeen (17) states had enshrined into law “requirements that medical liability or malpractice cases be heard by a screening panel before trial.”6464 See id. (quantifying how many states have adopted provisions for mandatory or permissive, binding or non-binding forms of alternative dispute resolution, or alternatively, have required medical malpractice litigations to first pass through a legislatively mandated screening process before being permitted to proceed through the judicial system). Although the general trend is to require some form of ADR or pre-trial screening, one state in particular, Nevada, eliminated its “medical-legal screening panel” and replaced it with “a less expensive process,” providing for the submission of expert affidavits.6565 See Szydel v. Markman, 121 Nev. 453, 459 (Nev. 2005) (phasing out N.R.S. 41A.016, which “required that medical malpractice claims be submitted to a medical-legal screening panel before proceeding in district court”). In June 2002, “the [Nevada] Legislature enacted various measures intended to reform the way medical malpractice claims are handled, including completely eliminating the requirement for prescreening of medical malpractice cases by the medical-legal screening panel and requiring medical malpractice actions to be accompanied by an expert’s affidavit.” See id. at 201-202.

Costs aside, pre-trial screening panels serve an important role in weeding out unfounded medical malpractice cases from those cases with actual merit— “the legislative purpose [is] discouraging frivolous claims . . .”6666 See Salem Orthopedic Surgeons, Inc. v. Quinn, 377 Mass. 514, 520 (Mass. 1979) (internal quotation marks omitted) (citing Austin v. Boston University Hospital, 372 Mass. 654, 655 n.4 (1977)). Although the impediment of a pre-trial screening panel on frivolous malpractice claims is undoubtedly a boon to medical practitioners, Massachusetts also passed such legislation to discourage frivolous claims “whose defense would tend to increase premium charges for medical malpractice insurance.” See id. Without the screening process, “insurance premiums would necessarily increase in proportion to the costs of defending against frivolous claims.” See Little v. Rosenthal, 376 Mass. 573, 577 (Mass. 1978). In Massachusetts, a medical malpractice tribunal, comprised of a Superior Court judge, a physician, and an attorney, is tasked with “determin[ing whether] the evidence presented if properly substantiated is sufficient to raise a legitimate question of liability appropriate for judicial inquiry or whether the plaintiff's case is merely an unfortunate medical result.”6767 See Mass. Gen. Laws ch. 231, § 60B (emphasis added) (codifyingMassachusetts’ version of a pre-trial screening panel). At the tribunal, “[i]f a finding is made for the defendant or defendants in the case the plaintiff may pursue the claim through the usualjudicialprocess only upon filing bond in the amount of six thousand dollars . . . payable to the defendant or defendants in the case for costs assessed . . . if the plaintiff does not prevail in the final judgment.” See id. The  conjunction “or” in the preceding sentence is instructive in that when and if the tribunal determines that there was merely an unfortunate medical result, the evidence has been determined to be insufficient to raise a legitimate question of liability.

Brace v. Massachusetts provides an example of a prescription medication claim in the context of a properly functioning pre-trial screening process.6868 See generally Brace v. Massachusetts, 673 F. Supp.2d 36 (D. Mass. 2009). In Brace, after having been arrested after a parole violation, the plaintiff’s decedent complained to a correctional officer and members of the jail’s medical staff that “she was suffering from headaches and frequent vomiting that she attributed to her abuse of alcohol and to the fact that she did not have access to the prescription pain medication that she took for knee pain and ulcers.”6969 See id. at 37-38. She threatened to harm herself if she were not administered pain medication.7070 See id. at 38. The woman was removed from the general jail population, transferred to the medical unit, and security checks were ordered to be performed every fifteen minutes.7171 See id. Unfortunately, after a twenty-minute lapse medical personnel returned to find the woman not breathing and without a pulse.7272 See id. She was pronounced dead shortly thereafter.7373 See id.  

On the same day that the Massachusetts medical malpractice tribunal conducted its hearing in the Brace litigation, the tribunal issued a report finding that “there was not sufficient evidence to raise a legitimate question as to liability that would be appropriate for judicial inquiry.”7474 See id. After the plaintiff failed to post a bond within thirty days of the tribunal’s decision,7575 See Mass. Gen. Laws ch. 231, § 60B (stating the requirement of posting six thousand dollars ($6,000) bond within thirty (30) days if the tribunal finds that there was not sufficient evidence to raise a legitimate question as to liability that would be appropriate for judicial inquiry).  the medical malpractice claim was dismissed with prejudice.7676 See Brace, 673 F. Supp.2d at 39. This is one example of a functioning pre-trial screening process in the context of a prescription medication claim, where “an unfortunate medical result” was not permitted to proceed absent financial assurances in the event of an adverse verdict.

IV. Conclusion and Recommendations

Drug-seeking or doctor-shopping patients, struggling with addiction or habituation issues, put prescribers in the unenviable position of being exposed to claims of malpractice related to their medical decisions in connection with pharmaceuticals. Under these circumstances, prescribers’ decisions, if made in good faith, should be given increased deference, akin to a corporate officer’s decisions under the business judgment rule.

Most importantly, rather than to allow hindsight bias to cloud the fact finder’s judgment, defense lawyers must focus judges and jurors not on the outcome of a given prescription regimen, but on the process undertaken by the doctor or nurse. Given the myriad complexities involved in finding a prescription regimen that is “just right” for each individual patient, prescribers’ decisions should not be subjected to what is essentially a “de novo” review, without context. The authors here advocate that in fairness to the prescribing physicians and nurses, their medical decisions should be evaluated in a manner more closely resembling the “clearly erroneous” or “abuse of discretion” standards.

The tension between the heightened level of scrutiny given to prescriptions and the increasing public awareness of the opioid crisis has lead legislatures around the country to more fully appreciate the potential for frivolous medical malpractice claims. Not for these cases alone, but in a positive trend, many jurisdictions have mandated varying forms of alternative dispute resolution, or have implemented pre-trial screening panels, in an attempt to weed out unfounded malpractice claims from those with arguable merit. Even so, the perils of prescribing medication abound, and second guessing of physician and nurse decisions is rampant. A defense based upon good faith, trust in the profession, and appreciation for the Goldilocks Principle, along with supportive expert testimony, offers the best chance of a defense verdict in this type of malpractice claim.

 

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