Health Canada asks Patients to Comment on Safety of Medical Devices
Medical malpractice is perhaps the most challenging and complex area of personal injury law in Canada. Liability in these cases is difficult to establish and proof of error difficult to secure. Cases involving implanted medical devices are even more complex than usual. Who is to blame when a person suffers adverse effects from an implanted medical device? The doctors who prescribed it? The surgeons who installed it? The researchers who developed it? The manufacturers who assembled it? These are examples of the difficult questions a medical malpractice lawyer must answer.
A new initiative by Health Canada may help reduce malpractice lawsuits related to faulty medical devices. On June 14, Minister of Health Ginette Petitpas Taylor ‘launched consultations that give Canadians an opportunity to comment on proposed changes to regulations that would further ensure the safety and effectiveness of the medical devices they use,’ according to a Health Canada release.
“Canadians rely on medical devices to maintain and improve their health,” Petitpas is quoted as saying. “Last fall, I committed to Canadians that we would take action to improve the safety of these devices. This consultation is an important part of that commitment. These proposed changes would make it easier for Health Canada to monitor the safety of medical devices already on the market and to take action to protect the health and safety of Canadians.”
The changes require manufacturers of medical devices to do the following:
- Assess the safety of their products and perform further safety testing relating to identifiable issues, when requested
- Provide a safety and effectiveness analysis of the product to Health Canada for a post-market safety review, and
- Prepare summary reports of known adverse effects, reported problems, incidents, and risks and notify Health Canada of all changes to risks or benefits.
As every Canadian medical malpractice lawyer knows, implanted medical devices such as pacemakers, joint replacements, hernia and surgical mesh, and breast implants have been linked to myriad health issues. Plaintiffs suffering from chronic pain and other ailments relating to hernia mesh, for example, have launched several class-action lawsuits in the Canada and the United States. Health Canada’s public consultation initiative may help limit future implanted medical device complications and reduce the number of lawsuits addressing these problems.
If you or a member of your family is suffering adverse effects related to an implanted medical device, contact Will Davidson LLP to speak with an experienced medical malpractice lawyer today. Our team will provide guidance and advice as you consider your legal options.
Image credit: U.S. Air Force photo by Katie Hursey