Risk Management

Lack of Informed Consent for Use of Research Drug

By Mary Kasher, MSN, JD
OMIC Claims Manager

Digest, Fall 2000

Allegation

Lack of informed consent for use of investigational drug during cataract surgery.

Disposition

Plaintiff dismissed insured ophthalmologist from suit.

Case Summary

The plaintiff was a 57-year-old woman who had been a patient of the insured for several years during which time her refraction had changed every two or three years. At one visit, she complained of glare and a starburst effect along with a continued decrease in vision. VA OD was 20/70 and OS 20/80. After a discussion of the treatment options available (which included cataract surgery or continuing to adjust her refraction), the patient chose cataract surgery. She also agreed to participate in an ongoing research study on the effects of an experimental drug for cataract surgery after discussing the possible risks and complications of the drug with the ophthalmologist. The consent form was signed and witnessed and the patient was given a copy to take home.

The surgery was uneventful. Intraocular pressure in the surgical eye was normal at the end of the procedure in the surgical eye after the experimental solution was instilled. At the first postoperative visit the following day, intraocular pressure was again normal and vision was improved. Later, the patient recalled going to church and being amazed at how well she could see. About a week after the surgery, the patient began to notice that it took a long time for her eyes to adjust from bright outdoor light to dim indoor light and that her right eye appeared much hazier that the left one. She called the insured’s office the next morning. Upon examination, the insured found peripheral vision in the right eye to be extremely decreased. The patient was experiencing complete darkness or blindness from her outer vision to the center of her vision where she had a small “hole” of vision that appeared to be in focus. The dark area has not improved since this evaluation. The actual cause of vision loss was never determined, although there was conjecture that it was the result of an injury to the retina related to the investigational drug or transport solution.

Analysis

Every medical research project varies in purpose and design, but two areas consistently surface as primary issues under legal analysis: lack of informed consent and any breach in the research protocol. Anytime a procedure involves an experimental substance or process, the patient must be fully informed of the risks involved and sign the “approved” informed consent form for that particular program. Instructions for obtaining informed consent in a research situation must be followed without variation or the consent will be considered flawed and challenged for validity. The research protocol setting out the criteria by which patients are eligible for study and how the procedure is to be conducted also must be followed without exception.

In this case, the insured followed the consent protocol meticulously. All designated forms were signed and placed in the record, and the testimony of the office staff and the patient herself supported all signed informed consent documents. In addition, the insured made an exceptionally strong appearance at his deposition. He was well prepared and presented the facts and circumstances clearly and with appropriate concern. The plaintiff attorney was so impressed with the insured’s performance and clarity of his records that he decided it would be better for the plaintiff’s case to dismiss the insured.

Risk Management Principles

The insured’s dismissal from this legal quagmire demonstrates some sound legal principles for medical practice. When participating in a research study, it is extremely important to follow the protocols with particularity. If any patient harm develops from the study, the entire process will be scrutinized. Medical research study cases present unique documentation challenges since the record can give the plaintiff attorney many avenues for finding noncompliance. It is the completeness of the documentation that will prevail in proving that research protocols were followed as directed.