Expanding Arizona patients’ access to telehealth and allowing practitioners licensed in other states to provide virtual care to patients in Arizona.
Discussing Danger: New Consent Process for Breast Implants in Arizona
Arizona’s new breast implant law was made effective this year which requires physicians to provide very specific information and consent form to patients.
Arizona’s new breast implant law, effective January 1 of this year, requires physicians to provide very specific information and use a six-page consent form for breast surgery and implants.1 Arizona’s law went into effect after the US Food and Drug Administration’s (FDA) October 2021-order requiring breast surgeons to provide specific information and use a 16-page consent form.2 Both informed consent processes and forms must be used by Arizona breast surgeons and patients.
Consent, Battery, and Medical Negligence
Consent is a key component of a common law claim of battery and to allegations of negligence by a physician or other licensed health care professional. Battery and negligence are similar but also very different.
The Arizona Supreme Court defines battery as an intentionally harmful or offensive contact with another person,3 and distinguishes battery in medical professional liability cases as medical procedures conducted outside the patient’s consent.4 Negligence, however, occurs when 1) the physician’s or other licensed health care professional’s acts or omissions fall below the legal standard of care and 2) that deviation caused the patient’s or plaintiff’s injuries.
In other words, there are two causes of action related to consent:
- battery, where the physician or medical professional performed acts outside the patient’s consent; and
- negligence, where the patient consented to the acts but experienced an injury because the patient’s consent was incomplete or inadequate.5
For example, battery occurs where the patient consented to an injection of Demerol or morphine but instead receives an injection of fentanyl.6 Negligence may occur where the patient suffers from an undisclosed, material risk of a procedure or treatment that the physician failed to disclose.
Tailoring Informed Consent to the Patient and Procedure
Arizona physicians have long obtained patients’ informed consent for procedures or treatments and often ask MICA to provide a list of risks, benefits, and alternatives for their patient discussions. MICA hasn’t provided those lists for several reasons.
- Informed consent varies from patient by patient, procedure by procedure, and patient by procedure. By way of example, each candidate for laparoscopic cholecystectomy has different social, medical, and surgical histories. Risks related to smoking will apply to some candidates but not others.
Decisions about “material” risks and benefits and “reasonable” alternatives require professional medical judgment. The risk of delayed healing in the dermatology patient with systemic lupus, for instance, may not apply to the dermatology patient with no comorbidities.
- While there are Arizona statutes listing the elements of informed consent for abortion, human research, telemedicine, and mobile dentistry, the legislature has not provided similar statutes addressing most other medical procedures and treatments.
- Juries retrospectively determine what defendant physicians should have disclosed, did disclose and failed to disclose when the defendants obtained the patient’s informed consent. The jury listens to the plaintiff’s and the defendant’s expert witnesses testify to the standard of care for obtaining a patient’s informed consent and decides if the defendant physician disclosed and explained the necessary information.7 The process of obtaining informed consent makes the list of risks, benefits, and alternatives specific to the patient and the procedure.
Based on years of litigating informed consent issues, MICA’s defense attorneys have found that most expert witnesses testify consistently with a former ethics opinion from the American Medical Association (AMA) that the physician should provide the following information before the procedure or treatment:
- The patient’s diagnosis;
- The nature and purpose of the procedure or treatment;
- The material risks and benefits of the proposed procedure or treatment;
- Reasonable alternatives for the proposed procedure or treatment;
- The risks, benefits, and uncertainties of each alternative; and
- The risks and benefits of not having the procedure or treatment.
The AMA has updated the opinion, which now explains that, in obtaining a patient’s informed consent, the physician should include the following information:
- The patient’s diagnosis, when known;
- The nature and purpose of recommended interventions; and
- The burdens, risks, and expected benefits of all options, including forgoing treatment.8
The previous points, to which expert witnesses have testified, should still guide physicians’ informed consent discussions.
Arizona’s New Breast Implant Law
The new Arizona law requires breast surgeons to provide, in written or electronic form, the following:
- A description of the risks of breast implants and of the medical procedures used in the breast implant surgery;
- A copy of the breast implant manufacturer’s written or electronic product information including the FDA black box warning;
- The Arizona Breast Implant Patient Checklist that includes, at a minimum, information about the following:
- breast implant-associated anaplastic large cell lymphoma,
- breast implant illness, and
- the national breast implant registry;
- Information on how to report adverse events associated with breast implants through the FDA’s MedWatch program or any similar program.
Physicians now have more responsibilities before breast implant surgery and must do two things under state law:
- Provide the information recommended by the AMA (cited above) to comply with the standard of care; and
- Comply with the new Arizona law, including using the 6-page consent form called the Arizona Breast Implant Patient Checklist.
- Provide the information recommended by the AMA (cited above) to comply with the standard of care; and
New Federal Requirements
The FDA added a third item to the list of physicians’ informed consent responsibilities – comply with the FDA’s requirements for informed consent, breast implants, and surgery. In October, the FDA restricted the sale and distribution of breast implants to health care professionals and facilities utilizing the FDA’s new Patient Decision Checklist.9 In addition to complying with Arizona’s requirements, physicians must also do the following:
- Review the FDA’s 16-page checklist information with the patient,
- Give the patient the opportunity to initial and sign the checklist,
- Sign or ensure the implanting physician signs the checklist, and
- Provide the FDA sub guidance documents and information referred to in the checklist.10
The FDA’s Patient Decision Checklist alleviated many patients’, physicians’, and patient advocates’ concerns regarding previously approved patient information booklets, which were often 40 pages or more. The Checklist could prevent failure-to-warn claims against implant manufacturers, but the sufficiency of an FDA-required checklist has not been tested in product liability litigation.
Implications for Medical Professional Liability
Arizona’s courts have not rendered a decision on the use of a statutorily required checklist in a medical professional liability (MPL) lawsuit. The amount of information in the approved two checklists, and the requirements for the patient’s initials and signature, may protect physicians against allegations of failure to obtain informed consent if they also provide the standard of care information that will be the subject of expert witness testimony in a MPL suit. Physicians should continue to also document the patient’s informed consent in the medical record, disclose information about any material risks of the procedure, and answer any questions patients may have regarding breast implantation.
2 The FDA’s announcement for breast implant safety requirements also addresses the labeling requirements for saline and silicone gel-filled implants, which include a boxed warning; the checklist; materials and device descriptions, rupture screening guidelines, and patient device cards.
3 Duncan v. Scottsdale Medical Imaging, Ltd., 70 P.3d 435, 205 Ariz. 306 (Ariz. 2003), citing RESTATEMENT (SECOND) OF TORTS § 13, 18 (1965).
4 Duncan v. Scottsdale Medical Imaging, Ltd., 70 P.3d 435, 205 Ariz. 306 (Ariz. 2003)
6 Id. at 848
7 Duncan v. Scottsdale Medical Imaging, Ltd., 70 P.3d 435, 205 Ariz. 306 (Ariz. 2003), citing Hales v. Pittman, 576 P.2d. at 499-500, 118 Ariz. At 311-12 (Ariz. 1978).
8 American Medical Association. Code of Medical Ethics. Opinion 2.1.1 informed consent. AMA Code of Medical Ethics Opinions on Consent, Communication & Decision Making.
9 The Patient Decision Checklist is in Appendix B, on page 10, of FDA’s guidance document, available for downloading, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication.
10 The sub guidance forms are Considerations for a Candidate for Successful Breast Implantation, Risks of Breast Implant Surgery, Risk of Cancer-Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Systemic Symptoms, Breast Implant Specific Risks, Recommended Follow-Up, Questions for My Physician, Options Following Mastectomy, and Breast Augmentation Options. The forms are part of the FDA’s original breast implant recommendations and are incorporated into the Patient Decision Checklist.
The content of this publication or presentation is intended for educational purposes only; is not an official position statement of Mutual Insurance Company of Arizona (MICA); and should not be considered or relied upon as professional, medical, or legal advice or as a substitute for your professional judgment. Consult your attorney about your individual situation and the applicable laws. The authors, presenters, and editors made a reasonable effort to ensure the accuracy of the information at the time of publication or presentation but do not warrant or guarantee accuracy, completeness, or currency of such information. As medical and legal information is constantly changing and evolving, check for updated information and consult your attorney before making decisions.