Our society has become much more litigious over the years. We see it on the news, we hear about it more and more, and we simply feel this to be true. Unfortunately, the data backs up these feelings, and one area where we see the proliferation of lawsuits is with malpractice in the medical space. Doctors are under more pressure than ever to perform within a system heavily laden with red tape, lest they be sued. 


In the 
2017 Medscape Malpractice Reportresearchers surveyed 4,000 physicians from over 25 specialties regarding their exposure to and experience with being named in a malpractice lawsuit. A stunning 55% of physicians said they had been named in a malpractice lawsuit, and of those who identified as having been sued for malpractice, 49% claimed to have been named in two to five malpractice suits. In the study, the top three specialties targeted by malpractice suits were 

  • Surgery – 85% 
  • OB-GYN and Women’s Health – 85% 
  • Otolaryngology – 78% 

Physicians are constantly in the line of fire of malpractice lawsuits, and the longer you practice medicine the more likely you are to experience the painful and emotionally draining process of a malpractice lawsuit. 

Informed Consent and Malpractice 

There are many reasons why a physician may be sued over malpractice claims, but we are going to take a special look at Informed Consents and what can go wrong with them that may lead to a malpractice suit. 

Can a Patient Sue for Malpractice if They Sign an Informed Consent? 

Yes, if a patient signs an Informed Consent, they can still claim malpractice. However, if an Informed Consent process is administered correctly, it’s very unlikely that the patient’s claims will hold up. According to an article published in AllLaw, a properly executed Informed Consent can bar a medical malpractice claim as long as: 

  • the consent form identifies the medical procedure and its known risks with reasonable adequacy 
  • the patient was not pressured to sign the form
  • the patient was mentally competent to sign the form 
 
Six Common Mistakes with Informed Consents that Lead to Medical Malpractice 
  1. Attention to Detail: The Devil’s Home 
  2. Using Non-Standard Forms or Non-Standard Language 
  3. Inadequate Description of Procedure and Risks 
  4. Patient Competency and Signing in an Altered Mental State 
  5. Signing Under Duress 
  6. Lost Forms – Spoliation of Evidence 

     1. Attention to Detail: The Devil’s Home 

The details matter tremendously when it comes to the proper administration of Informed Consent. There are many details that must be attended to in order to avoid the undue risk of malpractice exposure, and if doctors are too flippant about the details, this can lead to legal troubleAccording to a Medscape article from 2014 titled, “6 Ways Docs Go Wrong with Informed Consents,” common mistakes include: 

  • Failure to secure a witness signature from a healthcare professional 
  • The doctor does not always countersign the Informed Consent as the treating physician 
  • A lack of documentation on the date and time when a signature is captured from the patient and the physician

     2. Using Non-Standard Forms or Non-Standard Language 

Forms provided by the hospital, employer, or group practice have gone through robust review by both legal and compliance teams to ensure the forms properly protect the business entity, physician, and patient. All too often, physicians will take these standard forms and modify the language in some way, inadvertently creating malpractice risk. This simple mistake can also lead to a physician being fired, causing irreparable harm to their reputation. Changing a few words or sentences in a form is not worth ruining a career over. 

    3. Inadequate Description of the Procedure and Risk

A hallmark of malpractice suits when it comes to Informed Consents is a lack of specific information on the signed document regarding to the procedure being administered. Inadequate information regarding the description of the procedure and the associated risks are common culprits when it comes to malpractice claims.  

The Informed Consent process is more than a form. The Informed Consent process is a conversation between the patient and the doctor where the doctor explains the situation to the patient in plain language and encourages questions from the patient and their family. This conversation is this memorialized by signing the Informed Consent that contains the same detailed, yet approachable information discussed between the patient and their doctor. 

J. Scott Quinby, MD, Orthopedic Surgeon – Advanced Bone and Joint of Texas 

    4. Patient Competency and Signing in an Altered Mental State 

A 1914 case in New York set the groundwork for how principles of Informed Consent should be carried out. In this case, Justice Benjamin Cardozo explained that in the court’s opinion, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.” Simply put, a patient who is in an altered state is not of “sound mind” and unable to give proper informed consent. Therefore, should the patient be sedated, under the influence of other drugs, or in some state of psychosis, they are not able to provide legal informed consent. In other words, even if you have a patient’s signature on an otherwise perfectly executed Informed Consent form, the patients signature and therefore the entire document is null and void, which presents exposure of tremendous legal risk to the doctor and hospital.  

People are generally deemed to have read and understood the forms they have signed. However, if the patient was not competent to sign the form due to dementia, intoxication, or the effects of medication, legal or illegal, then the patient may indeed have a claim for lack of informed consent. - AllLaw 

    5. Signing Under Duress 

Patients may sign an Informed Consent but later claim that their signature is not valid because they signed “under duress. This means that the patient was experiencing high amounts of stress or that they were coerced in some way. A patient signing under duress could be brought about in a scenario where the paper-based Informed Consent has gone missing just before the surgery, the surgery is now delayed, and the patient is presented with a new Informed Consent to sign right before they are wheeled into the OR. The article “Signing Consent Forms Under Duress: Its Connection to Medical Malpractice” provides another good example of a situation of a patient signing under duress: “coercing a woman who is giving birth by saying to her that her baby will have birth defects  if she does not agree to a Cesarean birth. 

    6. Lost Forms – Spoliation of Evidence 

When you administer Informed Consents on paper, this paper can sometimes be misplaced and ultimately lost. Lost Informed Consents cause costly delays in the OR, according to a JAMA article titled, “Missing Consent Forms in the Preoperative Area, but lost Informed Consents pose costly legal risks, too. In the legal arena, this is referred to as the “spoliation of evidence. New York Supreme Court, Appellate Division case, Johnson v. Ayyub recently confronted this issue. Protectingpatientsrights.com provides an excellent summary of the case. 

 
Summary 

Informed Consents are essential tools in the practice of medicine, and while they may be routine, attention must be paid to the details. Otherwise, heavy legal repercussions can be brought to bear that will cost much more than money in the long run. 

For 20 years, Access eForms has helped hospitals convert paper-based forms across all hospital departments into paperless processes. In recent years, many hospitals have looked to Access eForms to help convert paper-based Informed Consents into EHR-integrated eForms that can be presented to the patient at bedside and used capture a patient’s electronic signature. Electronic Informed consents don’t get lost, time and date stamps are automatic, and language can be correct and consistent. Simply put, converting your paper Informed Consents to electronic Informed Consents by Access can save you time and money, reduce legal risk of malpractice, and improve the patient and clinician experience. 

If you’d like to learn more about paperless Informed Consents, we’d love to help, just as we’ve done with over 1,000 hospitals across the world. 

Contact Us

Additional Resources 

The Doctors CompanyInformed Consent: Substance and Signature 

PubMed: Enhancing informed consent best practices: gaining patient, family and provider perspectives using reverse simulation 

SVMIC: Informed Consent: Best Practices 

For the Record: Six Best Practices for Informed Consent 

 

Cody Strate

Written by Cody Strate

For more than 15 years, Cody has provided sales and marketing leadership with the goal of providing the smoothest, easiest, and most pleasurable customer experience imaginable. Cody is a Forbes Communication Council member and lives in Colorado with his wife, two kids, and two dogs.