Dow produced breast implants that were implanted in Hollis. After 17 months the implants ruptured inside of her body and caused injuries. Hollis is suing the company stating that they negligently manufactured the implants and that they failed to give the doctor (Birch) the proper information and he therefore could not give her enough information to make informed consent. The respondent was successful at trial and the Court of Appeal found that the appellant was not negligent in their manufacturing, but dismissed the appeal anyway because the defendant did not properly inform the doctor of the risks.
- Did the Court of Appeal err in finding Dow liable to the respondent for failing to adequately warn the implanting surgeon, Dr. Birch, of the risk of a post-surgical rupture?
La Forest, writing for the majority, states that manufactures generally owe a duty of care to the eventual users of their products. In the medical realm there is an even higher threshold for the duty because of the serious consequences that can result from a breach. All warnings must clearly describe any specific dangers that could result. This is related to making informed consent; if a patient does not know all of the information about a medical product/prescription that they use they cannot truly be said to give informed consent. This is true of the doctor-patient relationship as well as the patient-manufacturer relationship.
Although the general rule is that the duty of the manufacturer is only owed to the patient, in exceptional circumstances the manufacturer can satisfy its duty to the consumer by providing a warning to a learned intermediary, such as a doctor. Generally, this rule is applicable either when a product is highly technical and is only intended to be used under expert supervision, or where the nature of the product is such that the consumer will not receive a direct warning from the manufacturer before use. This rule only works to discharge the manufacturer's duty to the consumer, and not to the learned intermediary. This duty is discharged only when the intermediary has knowledge that approximates that of the manufacturer. The learned intermediary principle applies to this case; if Dow properly informed Birch of the dangers associated with the product then they would have discharged their duty owed to Hollis. However, La Forest finds that Dow did not adequately warn Birch of the risk of rupture.
On the issue of causation the majority states that the appropriate test to use to determine if this was a proximate cause is a modified objective test. They hold that you must ask if a reasonable person in Ms. Hollis' shoes, who had all of the proper information, would have decided not to have the surgery. They find that a reasonable person in this case would not have had the surgery and thus causation is established. They also hold that the fact that the doctor might not have discussed the risks with the patient, even if he had been informed, has no effect on the decision as there would be no way for Hollis to prove this.
Sopinka, in the dissent, states that the test the majority applies to determine causation is a subjective test, which fails to take into account the inherent unreliability of a patient's self-serving assertions. They state that a pure objective test should be used – the same test used in doctor-patient relationships. Following fundamental tort principles, Hollis must prove that Birch would have warned her of the risks associated with the surgery, particularly those relating to rupture. Based on Birch's testimony about warning patients of the risk of rupture, he holds this would not have happened.
- Manufacturers in the medical realm owe a particularly strict duty of care to the eventual consumers because of the serious side effects that can result from a breach of this duty, however, they can discharge this duty to the consumer if they properly inform a "learned intermediary" (the doctor) to give them the same level of knowledge of the manufacturer in order to assist the consumer.
- When establishing causation in cases involving a failure to disclose medical risks, you must use a modified objective test and ask if a reasonable person in the patient's shoes, with all of the proper information, would have decided to have the surgery. If they would have decided against surgery, then causation is established.
- In learned intermediary cases the patient does not need to prove that the intermediary would have relayed the risks on to the patient if the manufacturer had properly informed them.