The professional standard for medical malpractice, traditionally set by custom, has come under scrutiny. The most common concern is that custom may not reflect actual best practices,1 and health care providers may be reluctant to adopt those newer, better methods because the custom standard will not protect them.2 That criticism assumes the custom standard was originally set in good faith, based on patient outcomes and not health care industry profits.
In their compelling piece, Customary Corruption, Professors Ani Satz (Emory) and Liza Vertinsky (Maryland) raise a further complicating factor. What if the customary standard of care has been influenced by profit-driven entities outside of the health care provider-patient relationship? Professors Satz & Vertinsky accomplish three things in Customary Corruption. They provide updated survey data on the jurisdictions’ use of custom in medical malpractice cases,3 case examples of pharmaceutical companies affecting the standard of care, and sharpened arguments against deferring to custom as the sole standard of care. Satz & Vertinsky advocate for “the abandonment of the professional custom standard for prescribing practices in tort.” (P. 763.) But it is clear they are laying the groundwork for further attacks on customary standards in medical malpractice and even other learned professions. (P. 764.)
Although custom still dominates medical malpractice standards, it is no longer universal. According to Satz & Vertinsky’s survey, twelve states adhere to the professional custom standard, fourteen have abandoned it, one state has a hybrid approach, and twenty-three states have unclear or conflicting law. (P. 717.) In seven of the states that have abandoned the custom standard, custom evidence continues to influence judicial outcomes. (P. 717.) Six of the states with the customary standard have expanded the scope of evidence to include more than customary practice. (P. 717.) In essence, Satz & Vertinsky “conclude that professional custom continues to play a critical, and in many cases determinative, role in physician liability in up to three-quarters of the states.” (P. 716.)
The dominance of custom leaves the medical malpractice standard vulnerable to manipulation, and Satz & Vertinsky turn to three examples from the pharmaceutical industry, in which companies expand the scope and volume of drug prescriptions. The manipulation includes both on-label, using a drug in the way described on an FDA-approved drug label, and off-label, using a drug in a way not approved by the FDA (often for different conditions).
The first case study, of Thalomid, demonstrates influence over the standard by pressing off-label uses of a drug with known safety concerns. In the 1950s and 1960s, thalidomide was widely used in Europe as a sedative. (P. 724.) Evidence of significant birth defects caused by thalidomide forced the manufacturer to withdraw its FDA application in 1962. (P. 725.) Though pulled from global markets, and despite its toxicity, thalidomide proved beneficial for ENL, a skin disease linked to leprosy. (P. 726.) Celgene, a subsidiary of a larger chemical company, acquired thalidomide in the hopes of finding new uses for it. (P. 726.) In 1998, Celgene obtained conditioned approval to use thalidomide, under the name Thalomid, to treat ENL. (P. 727.) With this approval, Celgene introduced the drug, rebranded as Thalidomid, to U.S. markets. Celgene focused on breaking into the lucrative cancer-treatment market, and by 1999, 90% of Thalidomid prescriptions were for oncology, a purpose not approved by the FDA. (P. 728.)
Celgene grew its sales team from twenty in 1998 to one hundred by 2002, and trained its sales force in the uses of Thalidomid for cancer treatment. (P. 730.) Celgene is also alleged to have “paid kickbacks—in the form of speaker fees, paid clinical trials, advisory board positions, and authorship of ghost-written articles—to physicians in exchange for prescriptions of its drugs.”(P. 731.) Significantly, those physicians who received more promotional contacts prescribed at a higher rate than those with fewer contacts. As Satz & Vertinsky note, this demonstrates “the ability of Celgene to influence professional custom and, ultimately, the legal standard of care.” (P. 732.) In 2005, the FDA approved a new version of thalidomide, Revlimid, for use in treating cancer. (P. 728.) Despite a lack of evidence of efficacy and concerns about safety, Celgene encouraged physician use of thalidomide to such a degree that, for some types of blood cancer, it became customary use. (P. 731.)
The second case study, of Zyprexa, also focuses on off-label use. Zyprexa is an antipsychotic drug that, as a side effect, makes patients easier to manage. (P. 722.) According to Satz & Vertinsky, Zyprexa’s manufacturer, Eli Lilly, marketed Zyprexa to institutions with vulnerable populations, such as nursing homes and assisted living facilities. (P. 741.) Moreover, Eli Lilly downplayed serious side effects of Zyprexa, including significant weight gain and elevated blood sugar levels. (P. 738.) In 2021, a New York Times investigation found at least twenty-one percent of nursing home residents were being administered antipsychotics, many to their detriment. (P. 734.) The residents receiving antipsychotics far exceeded the number who had conditions for which antipsychotics were useful. (Pp. 734-35.) Eventually, Eli Lilly faced thousands of lawsuits over health issues. (P. 739.) Unfortunately, negative information coming to light does not necessarily reset the standard: “Even after the lawsuits against Eli Lilly for off-label marketing were settled, and federal government programs were established to reduce use of antipsychotics in nursing homes, Zyprexa and other atypical antipsychotics continued to be used in nursing homes, though at lower rates.” (P. 742.)
The third case study, of Abduhelm, illustrates an attempt to influence the FDA and create custom via on-label use. Abduhelm was developed as a treatment for Alzheimer’s disease, which has no existing cure and no treatment capable of more than slowing its advance. Biogen, the drug’s manufacturer, was able to obtain accelerated FDA approval in 2021, despite the fact that its phase three clinical trials “did not appear to provide any measurable benefits.” (Pp. 746-47.) The FDA made some unusual moves during the process, including radically departing from its advisory committee’s recommendations and shifting from a traditional approval to an accelerated approval pathway. (P. 747.) Once approved, Biogen began a campaign to increase demand for Abduhelm. Specifically, it sought help from the Alzheimer’s Association to pressure physicians to prescribe Abduhelm. (P. 750.) Because there was a dearth of treatments and families were desperate, the efforts paid off. (P. 750.) Biogen also hired four physicians to work for them, speaking and writing positively about Abduhelm, despite limited evidence of its efficacy. (P. 752.)
Because drugs are often expensive, manufacturers need to ensure that they are covered by insurance, including Medicare. In this case, despite political pressure, the Centers for Medicare & Medicaid Services (CMS) refused to extend Medicare coverage to Abduhelm unless patients were enrolled in clinical trials. (P. 753.) Although the decision was detrimental for Abduhelm, Biogen was developing a similar drug, Leqembi, as it was marketing Abduhelm. Apparently safer than Abduhelm, Leqembi nevertheless “seems to offer small to uncertain benefits and brings with it safety risks and high costs.” (P. 755.) Once Leqembi received full FDA approval in July 2023, CMS removed reimbursement restrictions on Leqembi. (P. 755.) Biogen is now focused on increasing sales of Leqembi, including a thirty percent increase in its sales force. (P. 755.) Given the lack of alternatives, Satz & Vertinsky predict that the use of Leqembi will become the standard of care for treating Alzheimer’s disease, at least in some jurisdictions. (P. 756.)
In all three case studies, Satz & Vertinsky note that manufacturers stand to gain from expanding the “range of uses for and users of its drug.” (P. 723.) Expansion helps set the customary standard of care. Of course, if the drug is safe and effective, no patient harm will result. But “in other contexts, the distortion of prescribing decisions is detrimental to patients and wastes resources on ineffective care.” (P. 723.)
Satz & Vertinsky conclude by making the case for abandoning the customary standard and moving to a reasonable person standard for negligent prescribing. (P. 756.) Such a move would clarify the muddled use of custom identified in their jurisdictional survey. (Pp. 757-58.) Moreover, moving to a reasonableness standard would create more accurate outcomes because non-custom evidence would become admissible, including evidence of corporate influence on the profession. (P. 760.)
Satz & Vertinsky identify the strongest counterargument as a concern about judicial or juror incompetence. (P. 761.) They respond by stating that even though medicine involves complicated scientific evidence, prescribing cases also involve informed consent to drug protocols and harm from drug use, issues within the competence of a judge or jury. (P. 761.) Satz & Vertinsky also point out that incompetence is a two-way street; without admissibility of non-custom evidence, jurors and even judges may be ignorant of “corporate influence on professional custom and the legal standard of care.” (P. 761.)
Satz & Vertinsky have opened an additional front against the professional custom standard, and I look forward to their future pieces. But before moving on, it makes sense to evaluate their preferred solution of the reasonable person standard. Satz & Vertinsky state there is no indication that litigation became more burdensome in those jurisdictions that moved to a reasonable person standard. (Pp. 762-63.) And that makes sense. Moving to the reasonable person standard should not change medical malpractice litigation dramatically. But the changes would be mostly positive.
Custom evidence is highly influential to juries. With the vagueness of the reasonable person standard, jurors are hungry for objective evidence. Being told that a large number of people in an industry do something in a particular way is like a lifeline. And the more complex the industry is, the more likely the reliance on custom. Medical practices are among the most complex that jurors encounter. Therefore, juror reliance on custom will almost certainly persist even if custom is not the sole benchmark. Jurors are likely to move away from custom only if presented with compelling evidence against it. Satz & Vertinsky have pinpointed one type of compelling evidence: corporations have influenced custom in ways that are sometimes inconsistent with patient care. But jurors will never receive that relevant information, and will not make decisions informed by it, if the professional custom standard is retained.
Customary Corruption is important scholarship, and Satz & Vertinsky are to be commended for it.
- Restatement (Third) of Torts: Medical Malpractice § 5, cmt. c (“[P]revailing professional practice may fall short of what medical professionals themselves regard as competent; in these circumstances, it should be no defense that many other providers render similarly deficient care.”).
- See, e.g., Philip G. Peters, Jr., Modernizing the Medical Malpractice Standard of Care, 52 Sw. U. L. Rev. 465, 471 (2024) (“Researchers have found remarkable delays—as much as a decade—in the adoption of new best practices, even where their superiority is not in dispute.”).
- See Phil G. Peters, Jr., The Quiet Demise of Deference to Custom: Malpractice Law at the Millennium, 57 Wash. & Lee L. Rev. 163 (2000).
