Defective Product Versus Failure to Warn

By Jordan Assaraf, Lawyer

We live in a society where we expect our public and private institutions and fellow citizens to act in a way that keeps us reasonably safe and secure. Of course, there will always be some risk of injury as we go about our business. But it’s simply not practical to spend our days wearing bubble wrap while sitting perfectly still in sterile rooms. What happens when the negligence of others creates an unreasonable hazard that leads to injury? Defective products can put us at risk, and a failure to warn people of defects can prevent us from doing our own due diligence to protect ourselves from reasonably foreseeable harm. In this blog, I examine negligence in terms of product liability and explain the difference between negligence resulting in a defective product (in manufacture or design and a failure to warn consumers/users about a product’s foreseeable and inherent risks.

Product liability law

A manufacturer can be held liable for a defective product based on contract law, statute law or tort law. Unlike a majority of American states, Canada does not import the concept of strict liability into product liability tort law. Where strict liability laws exist, a plaintiff usually does not need to establish that the defendant acted carelessly and demonstrated fault or negligence, if the defendant produced a defective product that caused an injury. Canadian common law requires a plaintiff to establish that (s)he was owed a duty of care by the defendant, that the defendant breached that duty of care, that (s)he suffered damages, and that those damages were caused by the defendant’s breach of the duty of care when assessed against a negligence standard. In such cases, the “but for” test is used as a measure. In other words, the plaintiff is required to prove that “but for” the negligent actions or inaction of the defendant, (s)he would not have suffered damage or loss. To be considered defective, a product must be determined to have fallen below reasonable standards in its design, manufacture or labelling, and that it posed an unreasonable danger to a person or their property when used in a reasonably foreseeable manner.

Design and manufacturing

When making a product, a manufacturer must take care to ensure its design is reasonably safe. If there is evidence that a safer design was available, but the defendant failed to adopt it due to a lack of reasonable care or skill, negligence could be proven. However, there are varying thresholds at play and courts sometimes use a “risk-utility” test to balance whether a safer design was worth the cost or whether other safety issues could arise in relation to a different design. The manufacturer must also use reasonable manufacturing processes when creating the product, including quality and compliance control processes. In meeting his or her burden of proof, a plaintiff must establish that the manufacturer’s negligence during this process caused the defect and the plaintiff’s resulting loss. The standard is not perfection and some product defects may occur during the manufacturing process even if the manufacturer was shown to be taking reasonable care.

A failure to warn

Defects in design and manufacture occur prior to a product being released to an end-user. But manufacturers also have a duty to warn end-users (or “learned intermediaries”) if there are material risks inherent in using the product (or foreseeably misusing the product) that would not be obvious to a user. The duty to warn includes properly labelling a product and providing reasonable directions or instructions explaining how to use the product. For products that require highly technical knowledge – for example, prescription medications, medical devices or products requiring service technicians – the manufacturer is responsible for providing direction to a “learned intermediary”. For example, in a case called Maxrelco v Lumipro Inc., (2018 ONSC 3638), the Court explains the types of conditions wherein a service technician would have a duty to warn. In failure to warn cases, plaintiffs must prove that the manufacturers knew or ought to have known about a risk; that the manufacturer’s negligence led to a failure to warn or resulted in an inadequate warning; and that such a warning would have caused the plaintiff to act or use the product differently. For example, major lawsuits against the tobacco industry have alleged the tobacco companies knew of the substance’s cancer-causing risk but failed to warn consumers.

Clearing the bar

Without strict liability, there’s an onus on the plaintiff to prove a product is not only defective, but also that a manufacturer’s negligence caused the harm and damages. Deciding whether a manufacturer’s actions or inaction failed to keep a consumer reasonably safe is central to these cases. However, there are certain products that have a much greater capacity to cause harm. Courts have consistently found that products that are consumed or ingested (such as pharmaceuticals) or placed in the body (such as medical devices) carry a much higher risk for users if they are defective. Sometimes, when one of these defective products causes harm to many people, a class action or mass tort may be launched to sue collectively for damages. For example, thousands of patients who received the DePuy Attune Total Knee Arthroplasty implant have experienced a device failure resulting in pain, instability, swelling/abnormal warmth, stiffness or limited mobility, and many have required corrective surgeries. This shockingly high failure rate has led to serious investigations, with numerous orthopedic surgeons calling into question the quality and integrity of the device. A good number of patients who received the DePuy Attune Knee System have already filed lawsuits against DePuy.

Are you injured?

If you or a loved one has suffered serious harm from a product you believe to be defective, it is worthwhile contacting a product injury lawyer to consider whether you have a viable case. If we at Gluckstein Lawyers agree to take your case, we will conduct a preliminary investigation at no cost to you to determine your options. It’s part of our commitment to full circle care. To learn more about how we can help, contact Jordan Assaraf.


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