I was pointed to this horror story, “Death Points to Risks in Research,” by the Wall Street Journal Health Blog’s post, “Hope trumped Skepticism as Patient Mulled Study Risk.” The problem was that there was not much time for mulling. The result is a controversy over whether or not what happened was a form of medical malpractice.

Breaches of clinical research standards and a federal oversight system that allowed key decisions to be made behind closed doors may have helped draw Mohr into an experiment that was not, her husband says, what she thought it was.

“It was presented to her like this is going to make her knee better,” said Robb Mohr, an agronomist who lived with his wife of nine years in a modest vinyl-sided ranch home near Springfield, Ill. “It was supposed to be just a simple thing.”

Company officials vigorously defend the study, saying they were upfront about risks, adhered to all regulations and were terribly saddened by the loss. “We’re human,” said H. Stewart Parker, Targeted Genetics’ chief executive. “This is not just a patient. This is a person, and this is a horrible tragedy.”

A two-sentence paragraph halfway through a 15-page consent document that Jolee Mohr signed warns of the possibility of “unknown side effects,” including, “in rare circumstances, death.”

Further in, after long descriptions of how the product may help, a single sentence states: “We do not expect you to receive any direct medical benefits from participation in this study.”

I have no way of knowing if the company’s response is accurate or if the grieving family has a valid complaint. The truth will have to be sorted out by the authorities. But this does demonstrate that clear communication and doing all one can to create realistic expectations is quite important if doctors want to avoid being pulled into medmal litigation. Medmal insurance providers themselves are providing training for doctors in how to ensure they have informed their patients of the risks and real possible benefits as fully as possible. Communication is an essential component to good medical practice.