Medical Research Cases/Consent and Informed Consent

Guide to Stewart v. Cleveland Clinic Foundation, 136 Ohio App.3d 244, 736 N.E.2d 491 (Ohio App. Dist.8 1999)

When was plaintiff's cancer diagnosed?

Where was the cancer and what type was it?

Was it found early or late?

What treatment was plaintiff offered if he did not participate in the clinical trial?

What treatment would be available if he participated in the trial?

What were the odds that he would receive the treatment if he joined the trial?

Was he told that there was evidence that chemotherapy could improve his chances of survival?

Was he told that there other cancer centers that were offering combined treatment as was available in the clinic trial?

Why do you think he was not given this information?

What did the plaintiff say he would have done had he know about the available alternatives?

When did they tell him he was cured?

When did they tell him he had incurable cancer?

When were the tests run that indicated this?

Do you have a question about his care in regard to this?

What was their FDA defense on the informed consent claim?

What did plaintiff's expert testify as to the causation issue on the effect of the combined treatment?

What was the plaintiff's testimony about whether the consent form met the federal standards?

What did Dr. Jay Katz say?  (Dr. Katz was one of the pioneers in analyzing consent to medical treatment.  This is a big gun witness.)

You can skip the review of the procedural issues: Paragraphs 53-98

What is the Ohio standard for informed consent?

How does this compare to the LA standard?

What did the court rule?