Plaintiff had breast implant surgery. Implants ruptured, and plaintiff needed corrective surgery to remove implants. Literature warned of rupturing during surgery, but not during normal use (post-surgery). Plaintiff sued surgeon and manufacturer (Dow Corning)
** Action against surgeon dismissed: risk of injury that materialized was not well-known.
** Action against Dow successful: liability based on implant being negligently manufactured.
BC Court of Appeal:
** Allowed appeal and ordered new trial on surgeon’s liability
** Dow liable: not due to negligent manufacturing, but due to failing to warn of risks of post-surgery rupture even though had knowledge.
If a manufacturer does not adequately warn users of its products of the risks, is it liable for injuries caused by the materialization of those risks?
A manufacturer is held a higher standard of care, and can only be said to have discharged its duty to the consumer if it informs a "learned intermediary" who in turn informs the consumer, and the knowledge of the intermediary approximates that of the manufacturer.
1. Duty of care and standard of care:
** There is a duty to warn: requirement to warn of dangers that could arise from the ordinary use of the product.
** Manufacturers have more knowledge of defects and risks of using the product. The imbalance is rectified by imposing a duty of care on manufactures to warn users of risks, even after the initial sale of the good -- the standard of care for medical products is high.
** When there is a learned intermediary, duty of care to consumer can transfer from manufacturer to intermediary. However manufacture still has duty of care to the intermediary.
** Dow’s warning to surgeon was inadequate. Dow had knowledge of risk of post-surgery rupture (Dow had received a number of unexplained rupture reports).
2. Did breach cause injury:
** Would she have consented to operation if she knew risks?
*** Objective test? Subjective test? It is dependent on adequate information being given. Policy reasons: manufactures have to be held to high standard due to imbalance of knowledge. Here, a modified objective test necessary -- it asks whether a reasonable person in the patient's position, with the proper information, would have decided to have the surgery.
** Application of facts to case:
*** Plaintiff testified that she would not have had the operation if property warned of risks
*** Dow warned doctor only of dangers of extreme use, even though had evidence of dangers of regular use
Policy 1: Manufacturer would benefit (profit) from under-emphasizing the risks
** So they have a higher duty
** Duty to warn can be discharged by passing info to intermediary
Policy 2: If intermediary doesn’t pass info on, that is about the duty of the intermediary
** Because it is desirable for the plaintiff to be able to recover
** If Dow had properly warned surgeon, would surgeon have property warned plaintiff?
*** Obiter: Cannot ask plaintiff to prove a hypothetical (no onus on the plaintiff in this case, to prove that surgeon would have warned her if Dow had properly warned surgeon)
Appeal dismissed. Court of Appeal’s decision stands.
This case is also an exception to the But For test for causation: the court stated that Dow could not used the learned intermediary rule to shield itself from claims arising from its own negligence.