The 10 Biggest Legal Mistakes Physicians Make That Could Lead to Liability for Failure to Provide Informed Consent

Excerpted from The Biggest Legal Mistakes Physicians Make: And How to Avoid Them
Edited by Steven Babitsky, Esq. and James J. Mangraviti, Esq. (©2005 SEAK, Inc.)

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Executive Summary

Failure to obtain informed consent for medical procedures is one of the leading types of claimed negligence in medical malpractice litigation. These claims are often made when common risks or complications result, and plaintiffs claim in their lawsuit that had they been aware of this risk, they would not have gone ahead with the procedure. In some limited instances, plaintiffs may not even need an expert witness to prove their case. Consistent, well-documented procedures and protocols tailored to the physician’s area of expertise can provide solid defenses to these types of claims.

 

Mistake 1        Failing to Develop Standardized Written Consent Forms for Risks, Benefits, and Alternatives Attendant to Common Procedures

Physicians should always obtain consent, in writing, from a patient. The best written form is tailored to the procedure, listing the common risks and complications, the more serious risks and complications, and the benefits. The form should also indicate that alternatives to the procedure were discussed, including the alternative of not having the procedure, and that the patient decided to proceed. Many medical associations provide sample forms for common procedures that incorporate the common risks, benefits, and alternatives, and websites for these associations can be great resources. If a full, written form is not obtained, a detailed note in the chart (signed by the patient if possible) indicating that all of the patient’s options were discussed is the next best thing.

 

Action Step     Physicians should identify the common risks, the serious risks, and alternatives to common procedures in the practice. They should use this format in every informed consent discussion and document it.

 

Mistake 2        Failing to Have Procedures and Protocols to Ensure That Patients Have Been Advised of Risks, Understand the Procedure, and Have No Questions

Many physicians perform certain procedures on a regular basis. For these procedures, the office should develop a specific, detailed protocol (including a specific written consent form), since these procedures will be those most likely to result in a claim. This protocol may include when the informed consent discussion is to be held and which staff will confirm that the patient has consented, that the form was signed (with a copy), and that any other written materials were given. The more standardized the procedures, the better the defense is in a lawsuit, because a written or pattern policy, known and followed by everyone in the office, provides solid, consistent testimony, in addition to written documentation, to show that the patient was informed in all relevant aspects.

 

Action Step     Physicians should identify commonly performed procedures and develop a protocol on the informed consent (including documentation) process in the office.

 

Mistake 3        Failing to Obtain a Written, Witnessed Consent from the Patient

One of the best defenses to an informed consent claim is to have a document signed by the patient acknowledging that a discussion was held about the procedure and that the patient understands the risks and benefits of, and the alternatives to, the procedure. This form should be witnessed by another person, dated, and if the patient does not speak English, should be in the patient’s language or be signed by the translator. The terminology should be worded so that the average patient (or juror) can understand it. A form document for common and serious risks, benefits, and alternatives (including the alternative of not having the procedure) should be included, and should also indicate all questions were answered. The form should allow space for a physician to tailor the form for any issues particular to this patient. The form should be signed at least a day in advance of the procedure and should acknowledge receipt of any brochures, videotapes, or other audio-visual materials used in connection with the consent discussion. Initialing of paragraphs and pages is ideal. Many associations or organizations provide sample forms of common procedures.


Action Step     Physicians should develop standardized consent forms and use them for all procedures.

 

Mistake 4        Failing to Have an Informed Consent Discussion with the Patient in a Neutral Setting before the Procedure

The informed consent discussion should never happen immediately before the patient is to have the procedure. If it does, an argument is always made that the patient was nervous about the procedure and thus was not sure of the nature of the consent. Simply having this discussion and the documentation well before the procedure deflates such an argument by the plaintiff. Using a consistent time and place for this discussion supports written documentation. For example, every consent discussion should be in an office setting as opposed to taking place while a patient is on an examination table.

 

Action Step     Physicians should always have an informed consent discussion on a day (or days) prior to the procedure, and not have the discussion in an examination room, during an exam.

 

Mistake 5        Failing to Use Audiovisual Tools and Other Materials in the Informed Consent Process

Using audiovisual tools, videotapes, brochures, and pamphlets is an excellent way to ensure that patients understand a procedure. Documentation of the use of these materials can provide an excellent defense. A patient may testify, for example, that he or she was not aware or did not understand the risk of nerve damage, but if the patient recalls being given some brochures, and the chart indicates specific brochures were given, those brochures will be introduced into evidence and can provide an excellent defense to refute the plaintiff’s testimony. Often these materials provide simple, easy-to-understand discussions of the risks involved, which are easy for jurors to understand. A room dedicated to these tools can be used for the informed consent discussion. Documentation on the actual form, signed by the patient, of the tools used or given is even stronger evidence of plaintiff acknowledgment.

 

Action Step     Physicians should obtain audio-visual tools, brochures, and pamphlets; use them in the informed consent process; and document that the tools were used.

 

Mistake 6        Failing to Advise Staff of the Importance of Recognizing a Patient’s Lack of Informed Consent

Often in a lawsuit, staff from the physician’s office will be identified and called to testify. The better educated the staff on the issues, protocol, and documentation, the more helpful to the defense they can be. Having staff assist with protocols, ensuring that standard documentation is complete, and being alert to patient questions help to quell problems before the procedure and, if a claim arises, help to ensure solid testimony by a witness for the defense. Staff can be invaluable in spotting issues or problem patients and alerting the physicians to them before a serious problem or claim arises.

 

Action Step     Physicians should educate and train their staff to assist in the process and to recognize problems with patients early enough to resolve them.

 

Mistake 7        Failing to Use Laymen’s Terms

Physicians should ensure that all discussions with a patient and the forms a patient signs explain matters in simple terms. Doing so ensures that the patient truly understands the issues and gives consent, as well as assists in explaining to the jurors that the patient was able to understand the risks, benefits, and alternatives. For example, the risk of nerve injury to the mouth should describe the potential injury as not only motor and sensory nerve damage, but also should identify symptoms, such as numbness, tingling, drooling, and difficulty chewing and speaking, temporary or permanent, which are terms that are easily understandable.

 

Action Step     Physicians should use terminology that is easily understandable to the average patient (or juror).

 

Mistake 8        Failing to Document Informed Refusal of Treatment

Just as important as documenting the informed consent process is documenting the refusal of treatment. Although not as usual a situation, all of the same principles apply, and often the risk of refusal carries a much more serious risk of injury or harm. Exceptional care should be taken with the process of discussing the risks, benefits, and alternatives; the reasons for the refusal; and the relevant documentation. A patient’s signature and acknowledgment are often critical. Follow-up documentation of further discussion with the patient may often be necessitated by the standard of care. Patient refusal of treatment may also include requests to call in family members or others to ensure that the patient is making an informed refusal, all of which should be documented.

 

Action Step     Physicians should be aware that informed refusal requires even more action and documentation than informed consent.

 

Mistake 9        Delegating Informed Consent Duties to Other Providers and Relying on Institutional Forms

Physicians cannot rely on institutional or hospital forms. In litigation, the issue is whether the physician complied with the standard of care, and plaintiff’s experts will testify that the standard requires the treating physician to obtain the informed consent. Hospital forms are typically general, and not specific to that patient. There is no in-depth discussion of the procedure, and often the hospital consent is obtained by a practitioner, such as a resident or a house physician, who has no information on the patient’s history.


Action Step     Physicians should use hospital consent forms only as an extra step in or a double-check on the physician consent process.

 

Mistake 10      Failing to Document the Informed Consent Process

Documentation is key in defending a lawsuit. A well-documented chart on informed consent, with identification of many of the items listed in this section, and acknowledgment by the patient of the risks and alternatives may persuade a potential plaintiff’s attorney not to file a suit. If a suit is filed, documentation made contemporaneously will be evidence admitted for the jury to review. This documentation will solidly refute the plaintiff’s claim of a lack of informed consent and present powerful evidence. The more documentation on this process, the better.

 

Action Step     Physicians should fully document the informed consent process.

 

Conclusion

Physicians must take the time to assess their practice and their common procedures and develop standardized consistent protocols to achieve good informed consent. Documentation of all of these steps provides a solid defense to a claim.

 

Written by:

Linda J. Hay, Esq.

Peer reviewed by:

Anne M. Oldenburg, Esq.

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