Medical Malpractice: How Specific Is Your Informed Consent Form?

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It doesn't have to all-inclusive, but it should be somewhat specific.


informed consent SPECIFICITY IS A SAFEGUARD, NOT A TRAP A more-explicit informed consent form can reduce your malpractice risk.

You can't warn patients about every conceivable risk related to surgery, but the good news is no one expects you to. The general rule when it comes to informed consent is that practitioners need to explain to their patients all reasonably foreseeable risks and benefits.

That's an important distinction and one to consider if you're among the many who fear that a consent form that specifies any risks has to be all-inclusive — which is, of course, impossible. It's also unnecessary. The fact is, you don't have to fear specificity, and the trend toward more-explicit consent forms is reducing malpractice cases. In fact, surgeons who've had to defend informed consent cases usually learn an important lesson and respond by developing more explicit forms. Why wait for it to happen to you when you can learn from their experience?

Memories fail
Sure, it's easier to use single generic consent forms with blanks that are filled in based on whatever procedure the patient is consenting to, and many hospitals and surgical centers continue to do just that. That way, there's also no risk that the wrong form will be given to the patient. And yes, the generic form says the patient has acknowledged discussing the condition, the proposed treatment, alternative treatments, and the risks and benefits. But the reality is that patients often forget that they've signed such a form, let alone every detail that came up in preliminary conversations with the physician. Contact between the doctor and patient is often brief, and a year later, if a case is filed, neither is likely to remember much of what was said.

In the absence of an explicit consent form, a jury may be asked to choose between a patient who's experienced a complication about which he recalls no warning, and a physician who says she customarily informs patients about all foreseeable risks and complications, but who doesn't specifically recall what she told this patient. Needless to say, juries don't always come down on the physician's side in such instances. Note, too, that while the practitioner generally has the primary exposure for cases involving informed consent, the facility may also have exposure on a vicarious liability theory.

Burden of uncertainty
How explicit should consent forms be?

The essence of a useful statement on operative risk includes a statement that all invasive procedures involve risk and some can be serious enough to cause serious disability or death on rare occasions. If you include a list of major risks, including anesthesia complications, hemorrhage, infection, scarring and adjacent tissue injury requiring subsequent surgical management, you can also add a statement to the effect that there may also be other risks, perhaps not yet even identified, which occur very infrequently. If one or more features of the patient's condition make it more likely that he will encounter a specific complication or operative risk, you can even tailor the consent form to the particular case.

Incidentally, explicit consent forms do not deter patients from seeking necessary care.

There's simply no reason for practitioners to accept the burden of uncertainty inherent in a patient's situation, so why not make that clear in the consent form? If the form indicates that the patient has been given the opportunity to discuss the procedure and all questions were answered before he signed, the chances of a claim are markedly reduced. Plus, if one does get filed, the chance the provider will prevail is correspondingly greater.

Some providers experienced in outpatient elective surgery have prepared consent forms that document the patient's state of knowledge fairly extensively — some forms, in fact, consist of 8 or 10 initialed and signed pages.

Doubling down
While a surgical center or other facility might require that its own generic consent form be signed, there's no reason a practitioner or facility can't have the patient also sign a more detailed consent form that's tailored to the specific procedure.

If and when an informed consent case reaches trial, chances are good that the patient will have convinced himself that the complication he had to deal with was never disclosed to him before the surgery, regardless of whether that's true. However, if the consent form he signed specifically acknowledges that he was told of the risk of perforation at the time of a colonoscopy, for example, it will be difficult for him to find a lawyer and an expert witness who can support his claim.

Even if an explicit consent form isn't perfect, if it mentions risks far worse than the one that actually occurred, you can make the argument that the patient who accepted a risk of paralysis or death would certainly have accepted the risk of an unsightly scar on her abdomen.

Every practitioner who's been involved in litigation over informed consent would probably agree that all reasonable efforts to prevent such a claim in the future are worthwhile, including taking the time and trouble to craft explicit and specific informed consent forms.

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