Risk Management



Proper Office Techniques Can Offer a Strong Defense in Malpractice Cases

By Michael F. Henrick, JD

Digest, Fall, 1991

(Recently OMIC settled a claim during trial for an injury resulting from a known complication of cataract extraction and lens implantation. Although the clinical issues did not raise significant questions concerning the standard of care provided per se, defense of the claim was hampered by some very fundamental risk management issues concerning documentation and communication of the known risks of surgery to the patient. In his article, Mr. Henrick, an OMIC defense attorney with more than 17 years experience in medical malpractice, reviews some of the legal problems he has encountered in defending ophthalmologists and other surgeons, and provides useful suggestions on how to avoid these common pitfalls.)

In surgery cases, medical malpractice litigation seldom arises from improper technique or a failed procedure. This is particularly true in ophthalmic cases which most often result from a known complication inherent in the type of surgery involved. When this happens the patient’s attorney will usually pursue two theories of liability: either the surgery was unwarranted or the patient was completely uninformed.

Unwarranted Surgery

When a patient claims through an attorney that a surgery was not warranted, the patient is maintaining that the complication or risk that occurred would not have occurred if the ophthalmologist had exercised the appropriate standard of care and refrained from surgery in the first place. This issue is obviously easy to deal with if without surgery the person would have died or suffered a great injury such as blindness. The legal problem arises for the ophthalmologist who recommends surgery to improve the patient’s quality of life. Procedures such as cataract extraction and IOL implantation fall into this category.

In most cases, without cataract surgery the patient would be able to continue with life, albeit with diminished visual acuity. The promise to not only correct a deteriorating process, but also to restore visual acuity to a level not experienced by the patient in many years can create unrealistic expectations in some patients. If a complication arises in these cases and the patient feels that his or her vision is worse than before surgery, this patient will be more likely to take an adversarial position against the surgeon.

Lapse in Documentation

With cataract extractions and IOL’s becoming commonplace, the ophthalmologist may be less likely to document his reasoning in recommending surgery. Traditional patient complaints of sensitivity to bright lights and difficulty reading are less often noted in the office chart and their absence is called into question when litigation arises. The patient who experiences a complication is quite likely to minimize the vision problems he had before surgery. Instead of recounting conversations with the physician where the risks and complications of surgery were discussed, the patient will primarily recall assurances from the physician and the emphasized need for surgery.

In trial, the plaintiff’s expert witness, because of a lack of notation in the records, will testify that the signs and symptoms prompting the ophthalmologist to recommend surgery either did not exist or were not as severe as the ophthalmologist actually found. Without documentation it comes down to the word of a layman against the word of a professional. In my experience, the jury may be more likely to suspect the professional who having lapsed in the simple task of charting may have lapsed elsewhere.

In a case my firm defended a number of years ago the jury was called upon to determine whether certain symptomatology existed warranting surgery. The plaintiff brought in family members and friends to testify that no such symptoms existed and the patient had never complained of any problems. The physician testified that the patient related continuous and increasing symptoms. Unfortunately, his records did not contain any documentation of what the patient told him. In talking to the jury after the verdict was returned in favor of the plaintiff, I learned that this lack of documentation not only made them believe that the symptoms did not exist, but also tended to destroy the doctor’s credibility with regard to the other issues of the case.

This whole scenario can essentially be avoided. Medical students, in learning to document a patient’s condition, are taught the acronym S.O.A.P. Subjective, Objective, Assessment and Plan. By taking the time to create the routine of documenting these elements of patient care, the physician establishes for all future purposes, including litigation, what the patient said, what the physician observed, the physician’s mental process and treatment strategy. Physicians go through this mental assessment of a patient’s condition anyway and by documenting a line or two under each heading they can often avoid hours later in depositions and trial. (Figure I.)

Clinical test results are also important in documenting the necessity of surgery. If you are relying upon an A-scan result or an intraocular pressure, write down the exact finding. If it is important enough to consider in assessing the need for surgery, it is important enough to document.

Informed Consent

When a known complication arises from surgery, the patient, or more likely the patient’s attorney, will claim that in consenting to surgery the patient had no idea that such a thing could happen. Many physicians confuse the presence of a signature on the consent form with a true informed consent.

Basically, an informed consent is an understanding between the physician and the patient where the patient is told of the possible major risks and complications inherent in the procedure and the alternative treatments available. The consent form is merely a memorialization or some evidence of this understanding. A signature on a consent form is only the final culmination of a much more significant process. That is the dialogue between the physician and the patient where the latter is given an opportunity to fully understand the important step they are both about to undertake.

This process, if properly followed, allows the physician and the patient to develop a relationship or partnership whose objective is the ultimate benefit to the patient of improving his vision. By developing such a relationship the patient is much more likely to understand the physician’s position when the infrequent complication arises.

Such a relationship can only form by an interpersonal dialogue between these partners. The introduction of other office personnel as third and fourth parties to this process has the effect of distancing the original participants and creating the impersonal attitude that is necessary for litigation to develop. Signature on a consent form does not automatically result in dismissal of a lawsuit based on informed consent. Its significance will be severely compromised if the patient testifies that “The physician was in a hurry” or “I could not read the form and was told to sign it” or “It was a form that I was told I needed to sign if I wanted surgery.”

Establish a Routine

Ophthalmologists who do four or five cataract extractions and IOL implants in a day may be unable to recall the specifics of each case, and thus the routine for obtaining an informed consent becomes more important. Although the physician may not so much remember the specific conversation with patient Jones about the risks or complications involved, he should be able to establish that “this is the routine I always follow and these things tell me that I followed the routine in this case.”

What Do I Mean By Routine?

Time, place and person. The ophthalmologist should have a built-in routine for personally reviewing the entire consent form with the patient and should encourage the patient to ask questions.

Timing is important in dealing with the informed consent. The form should not be presented for signature until the physician meets with the patient and discusses the contemplated surgery. To ensure that the patient is familiar with the entire document in cases such as the multi-page form recommended by the Food and Drug Administration, the patient should not only sign the signature blank on the last page, but also initial all preceding pages.

Presentation of the form should not be made when the patient might have more difficulty reading such as after dilation of the pupils. Plaintiffs’ attorneys when confronted with an executed consent form oftentimes attempt to establish that the signature was obtained at a time when the patient was either under the influence of a pre-anesthetic agent or some analgesic. Many hospitals require that the consent form be executed prior to the day of surgery in cases of inpatient hospitalization or upon arrival at the hospital for same-day surgery. By establishing such a routine it can be later determined by comparison with the medication records and the testimony of the witnesses that the patient was competent when executing the form.

Presurgical Checklists

For ophthalmologists who find their practice does not lend itself to routine, another possibility in encouraging good documentation practices could be the use of a presurgical checklist. In defending hospitals as well as physicians, I have found that these lists insure that all the appropriate steps, including discussing surgery and obtaining informed consent, are completed before surgery. The list used can be tailored to a particular type or practice.

Unfortunately, litigation is retrospective in its evaluation of a physician’s performance and one cannot anticipate all things that will occur in the care of a patient. Following my suggestions is no guarantee that you will avoid litigation, but following a routine similar to that suggested here will make the job of the plaintiff’s attorney all the more difficult and increase the likelihood of a successful defense.

 

Figure IIncorporating the S.O.A.P.formula, Subjective information, Objective data, Assessment and Plan, into the patient record helps document the rationale for surgery.

S. Patient complains of increased difficulty with bright lights, glare and night driving.
O. Diminished visual acuity with glare testing.

Low Medium High
OD 20/30 20/30 20/40
OS 20/30 20/50 20/100

Visualization of cataract OS near center of visual field.

deskrefg1 picture
A. PCS of OS.
P. Discuss cataract surgery and alternatives with patient and schedule surgery if acceptable to patient.

 

 

 

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