Findings

As noted earlier, the following issues arise in this case:

• Were Vinay's parents provided with sufficient information to allow them to give informed consent to the procedure?
• Would Vinay have been taken to surgery with a potential infection if his parents had not intervened?
• Did the surgeon demonstrate the skills and experience necessary to undertake this high-risk surgery?
• What was the cause of death and was it preventable?

Were Vinay's parents provided with sufficient information to allow them to give informed consent to the procedure?

Findings

In the fall of 1993, the family was initially offered the opportunity to take their child to another heart centre. However, they were persuaded not to do so after it was determined that Odim would be arriving early in 1994. They seemed inclined to have the operation done in Winnipeg if it could be done here.

It is clear from the evidence that the Goyals were made aware of the major medical issues facing their child. However, it is also clear that neither Odim nor Giddins informed them about the level of Odim's surgical experience or the death of Gary Caribou.

It is difficult to say whether or not the Goyals might have consented to Odim performing the operation even if they had been aware of his lack of experience. But that issue is irrelevant to the question of their entitlement to receive an accurate answer to their query. Sheena Goyal had clearly asked Odim what his experience was in doing this type of operation, and he was less than forthright in telling them of his lack of experience. This evidence tends to suggest that Vinay's parents were not provided with sufficient information to allow them to give informed consent to the procedure.

Would Vinay have been taken to surgery with a potential infection if his parents had not intervened?

Finding

The operation that had been scheduled for April 6, 1994, had to be delayed because Vinay had an existing infection. The evidence suggests that the infection was discovered only after Sheena Goyal insisted that the team check for one-an alarming prospect, given the position of the VCHC on the danger that infections presented to children having heart surgery. This delay was appropriate, however, given the knowledge of such dangers, although it likely contributed to additional risks for Vinay's second operation. Swartz's ordering of tests to check for an infection was appropriate, but Odim's resistance to delaying the operation pending such tests was not. Additionally, it is noteworthy that despite the clear evidence of an infection, Odim seemed to be of the view that there was nothing to be concerned about.

Did the surgeon demonstrate the skills and experience necessary to undertake this high-risk surgery?

Findings

The failed repair from the first operation seems inexplicable. It is difficult to understand why Odim was unable to repair the heart defect properly. The procedure was not beyond the capabilities of an experienced surgeon. However, it cannot be overlooked that Odim was not an experienced surgeon, nor did the team have much experience in dealing with cases of any complexity.

The decision to re-operate on Vinay's heart 30 days after the initial operation was probably the only option remaining. It was obvious that the initial repair was unsuccessful and that without a re-operation, Vinay would likely die. It would also seem that Vinay was not in any condition to be transported any distance, although there was a possibility that another surgeon could have been brought to Winnipeg to perform the operation.

The events of the second operation include behaviour on the part of the surgeon that causes one to question his ability to perform these types of operations in an unsupervised setting. His action in dribbling adrenalin on the heart was foolish and potentially dangerous.

But the most serious action was that of removing the aortic cannula without properly preparing the team. The weight of the evidence suggests that proper notification was not given before the removal of the cannula. The removal of the aortic cannula during the critical and lengthy search for the cause of Vinay's bleeding contributed directly to this child's death. Removal of the aortic cannula compromised the team's ability to transfuse the child appropriately and caused them to fail to keep up with Vinay's blood loss. Vinay bled to death on the operating-room table. The evidence suggests that if the aortic cannula had been in place, the surgical team would have likely been able to keep up with his blood loss until the surgical bleed had been discovered.

As noted in the Caribou and Ulimaumi cases, Soder concluded that:

[T]he skill and dexterity of the surgeon performing these operations were insufficient for the challenge of successfully repairing infant hearts with complex malformations. Surgical factors were the prime determinants of fatal outcome in 9 of the 12 deaths. (Boldface in the original) (Exhibit 345, page 8)

The Goyal case was the third in which Soder identified major surgical factors leading to a patient's death. In this case he identified the incomplete repair in the first operation as a major factor, while the prolonged bypass and cross-clamp times in both operations were minor factors, as were the excessive bleeding and cannulation difficulties in the second operation. Soder indicated that the late decision to operate on the residual VSD was also a major factor.

What was the cause of death and was it preventable?

Finding

Vinay died due to bleeding during his second operation. The evidence suggests that this was a preventable death.

At this time in the program's history, three children had died, partly because the surgeon did not have sufficient skills to undertake the planned repairs. As the events recounted to this point in the narrative make clear, the program had been restarted and difficult procedures had been undertaken with insufficient planning. Three of the outcomes to this point were tragic. If there had been appropriate monitoring and review of outcomes, by this time, the program would have been subjected to a review, even if one had not been called after the case of Jessica Ulimaumi.