Medical Device Litigation

Medical device safety continues to be of concern to the public and a concern within health care. The Auditor General of Canada in a report delivered in March 2004, stated that Health Canada does not have a comprehensive program to protect the health and safety of Canadians from risks related to medical devices and this could translate into a growing risk – risk of both injury and liability.

Medical devices such as blood test kits, diagnostic imaging equipment, and heart valves are used to diagnose, treat, mitigate, and prevent diseases and medical conditions. Medical devices play an important role in all stages of the delivery of quality health care. The manufacture and sale of medical devices are subject to the Food and Drugs Act and the Medical Devices Regulations. According to the Food and Drugs Act, a medical device is defined as “any article, instrument, apparatus or contrivance, including any component, part of accessory thereof, manufactured, sold or represented for use in human beings and animals for:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms,
• restoring, correction or modifying a body function or the body structure,
• diagnosis of pregnancy, or
• care during pregnancy and at, and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug.
• Medical devices are largely based on technology. As advances are made in technology, the number of devices and their complexity will increase.
• The public has limited control over the risks and benefits to which they are exposed. Ultimately, they must trust others, such as health care professionals and manufacturers of therapeutic products, to provide safe and effective services and products.

Health care professionals play a significant role in helping to ensure the continued safety of medical devices for the public and they are often the first to become aware of an adverse event related to a device. This makes them the most important source of information on adverse events. When this information comes to their attention, they have a professional responsibility to pass it on to the manufacturer and/or the federal government. Their failure to warn can result in liability on their part in addition to the traditional reasons relating to negligent prescription, administration and use of medical devices.

The legal responsibilities of the medical devices industry are outlined in the Medical Devices Regulations. These Regulations place significant responsibility on the industry to do all it can to protect the health and safety of the public. Information on manufacturer liabilities is set out in our product liability section. The circumstances relating to products liability are of relevance and application to medical device liability.

In recent years, courts have held that in some circumstances public authorities could be found to owe a duty of care to certain persons. In cases where a public authority did not exercise diligence, the public authority may be found negligent and liable to those injured by that negligence.

Medical device claims are advanced when an adverse event incident occurs that has led to patient or user injury. It can be caused by failure of the device or improper use due either to human error or to inadequate labeling or directions.

If you have been seriously injured or suffer disability as a result of a defective medical device such as:

• cardiac pacemakers
• catheters
• contact lenses
• dental care products
• implanted electrical leads
• laser surgical tools
• orthopedic implants
• orthopedic surgical tools
• heart valves
• Sulzer hip and/or knee implant devices
• joint hip and knee implants from various other manufacturers
• Guidant Ancure Enograft devices
• temporomandibular implant
• TMJ implant
• glucose monitor
• laser eye surgery
• collagen
• insulin pump
• stent

then contact us if you wish to explore your legal rights and determine whether you are entitled to advance a claim.