Medical device manufacturers (“MDMs”) often have to defend against novel theories of liability put forward by plaintiff counsel. The most recent example is a trend in the United States of increasing claims against MDMs for an alleged failure to train.

U.S. Claims

In general, American courts have been reluctant to impose on manufacturers an affirmative duty to train. In Woodhouse v. Sanofi- Aventis, the plaintiff alleged that the MDM negligently omitted to train and educate a clinician. The Texas Court rejected this argument and ruled that the MDM did not owe the plaintiff any duty to train professionals in the proper prescription of Ambien.[1] Similarly, in Lemon v. Anonymous Physician, an Indiana judge found that the MDM “does not automatically have a duty to properly train, instruct or assist a physician on the surgical implantation and use of the device.”[2]

Courts in the United States have entertained the possibility of a claim based on duty to train in circumstances in which an MDM proactively undertakes to train. Plaintiffs have argued that when an MDM undertakes to train a clinician or attend a procedure, it has a duty to do so reasonably. The purported duty is in turn grounded in the Second Restatement of Torts, which codified voluntary undertaking theory.[3]

In Medtronic Inc. v. Malander, the court considered whether an MDM undertook a duty to facilitate proper installation of a pacemaker. During the surgery in question, the company’s representative assisted with device testing and its technical support person advised doctors as to device suitability. The court found that the voluntary undertaking allegation was a genuine issue for trial and refused the summary judgment.[4] Likewise, in Hurley v. Heart Physicians, the court declined to summarily dismiss a failure to train claim against an MDM, whose representative had advised the physician about the feasibility of lowering a patient’s heart rate.[5] A third U.S. court extended the potential duty to train even further: affirming that MDM representatives who attend surgery may have an obligation to advise physicians on the correct use of a medical device.[6]

Conversely, other American courts have rejected voluntary undertaking claims – even where the MDM representative was present in the operating room. In Kennedy v. Medtronic Inc., the plaintiff argued that a company representative who attended and advised physicians during her father’s pacemaker operation, “owed a duty to assist in a reasonable manner with the surgery once it voluntarily undertook to participate.”[7] However, the court found that it would be “unreasonable, and potentially harmful, to require a clinical specialist to delay or prevent a medical procedure simply because she believes the setting is not appropriate or the doctor is unqualified.”[8]

The two lines of authority can be difficult to reconcile. It appears that judges are more likely to entertain voluntary undertaking claims when the observed procedure was aberrant and/or the attending representative was actively engaged. On either interpretation, MDMs have a number of defences to an improper training claim. These include: identifying policy and floodgates concerns; casting the claim as educational malpractice; relying on the learned intermediary doctrine, raising causation questions, and citing the “captain of the ship” doctrine.

While failure to train claims have not yet migrated north of the border, they will doubtless arrive soon. In Canada, in order to establish a claim in negligence, a plaintiff must prove: i) the defendant owed a duty of care; ii) the defendant’s conduct did not meet the applicable standard of care; iii) the plaintiff sustained damages; and iv) the damages were caused by the defendant’s breach. This fourth requirement has two sub-criteria: i) the breach, in fact, caused or contributed to the damages and ii) the damages are not too remote to be compensable at law.[9]

The existence of a duty of care owed by a Canadian manufacturer to a consumer of its goods in a product liability claim is rarely a contentious issue.[10] However, there will necessarily be added issues of remoteness when the alleged harm is said to have arisen as a result of the training of a third party intermediary. To establish a new duty, a court would have to consider relationship proximity, foreseeability of harm and policy implications.[11]

In Karagiannis v Toronto Hospital, the interaction between a pacemaker, its adapter and the leads caused malfunction. The patient sued doctors for medical malpractice, and the manufacturer for failing to properly advise and inform the surgeons about the adaptor. The motion judge noted that duty of care is a “vibrant and dynamic instrument” and “the categories of negligence are never closed.”[12] There was no final determination of this case; however, it does suggest that Canadian courts may be opening to considering whether, notwithstanding the presence of the intermediary, the relationship between the MDM and the patient might be sufficiently proximate to establish a duty of care.

Nonetheless, it is uncertain that simply because it provides product information to experts, an MDM should foresee a reasonable risk of harm to ultimate patients. In Murphy v St. Catharines General Hospital, the Ontario High Court affirmed that the duty of a syringe manufacturer to hospital patients was mitigated by the presence of a learned intermediary.[13]

The standard of care that is imposed in Canadian tort law is one of reasonableness. Contrary to many American jurisdictions, Canadian courts do not typically adopt a strict liability standard in product liability cases. The relevant question is: Whether the nature of risk flowing from implantation of a medical device by a skilled professional required greater precaution than that taken by the defendant.[14] An MDM facing a failure to train claim would have to show that its warnings and guidance were consistent with industry practice and proportionate to the foreseeable risks of implantation.[15]

MDMs will continue to confront novel theories of liability raised against them. Duty to train claim could soon arrive in Canadian courts. The American case law demonstrates mixed results in these types of cases. Extrapolating from principles of Canadian product liability jurisprudence, it is our view that MDM’s can expect these types of cases to meet with questionable success north of the border.