Medical Device Malfunction

Using a product that malfunctions or breaks can be frustrating, costly and time-consuming as you look for a replacement. Fortunately, usually these malfunctions result in only minor irritation or inconvenience. But if the defective product is a medical device, the consequences could be dire. Malfunctioning medical devices can cause or worsen a person’s existing medical condition, result in a delayed diagnosis or misdiagnosis, and lead to serious personal injuries or even death. From 2008 to 2018, federal data indicates at least 1,400 Canadians died and 14,000 more were injured by medical devices that were supposed to help them. Underreporting of incidents means there were quite possibly many more serious injuries and deaths.

Although recent changes have strengthened the regulatory approval process, some medical devices have entered the market without the same rigorous evaluation required for pharmaceuticals - particularly when modifications to existing devices or novel uses for existing devices are given initial approval. Moreover, mandatory reporting of medical device problems by hospitals was only instituted by Health Canada in 2019.

One recent study found that five per cent of medical device recalls over a 10-year period were due to an identified risk of serious adverse health consequences or death. Unlike recalls involving other types of products, the steps involved in removing medical devices from the market can be much more complicated. If a defective medical device has been surgically implanted into a person, replacing the device may take time, and complete remediation of surrounding bones, nerves and body tissue may not be possible.

If you or a loved one has been affected by a medical device malfunction or recall, it is important to understand your legal rights. Gluckstein Personal Injury Lawyers’ knowledgeable, skilled and experienced medical device malfunction team is here to help in any way we can.

What are medical devices and how are they regulated?

Medical devices are any instrument or component used to mitigate, treat, diagnose or prevent a disease or abnormal physical condition.

Medical devices vary greatly in design and use. From simple devices (adhesive bandages, toothbrushes, contact lenses) to complex devices (x-ray units, insulin pumps, pacemakers), each device is given one of four classifications by Health Canada based on the anticipated risk to a person’s health and safety. Class I medical devices (a wheelchair) are low risk, while Class IV medical devices (a defibrillator) pose the highest risks.

Class II and higher devices must obtain a medical devices licence before they can be sold in Canada. A second type of licensing (medical device establishment licence) is required for companies to import (Class I to IV), distribute (Class I to IV) or manufacture (Class I) medical devices.

The approval process varies by medical device class. Licensing applications for higher risk devices (Class III and IV) must provide evidence of their clinical effectiveness, including clinical trials and reviews, meta-analyses and real-world evidence reviews. To be licensed, a medical device’s risks must be mitigated as much as possible and the regulatory agency must determine the benefits of its use outweigh any remaining risks.

Post-licensing monitoring includes: inspections, reports noting information that may change the device’s expected risks and benefits, and compiling information on recalls, complaints and problem reports from a variety of consumer and medical sector sources.

Examples of medical devices malfunctions and failures.

Gluckstein Personal Injury Lawyers has launched claims on behalf of many clients who have experienced medical device malfunctions or failures, including numerous class action and mass tort proceedings. Some recent examples of medical device malfunctions we have investigated include:

• the DePuy Attune Knee System - designed to improve stability and range of motion in knee replacements, patients have reported an array of complications following the surgery to implant the device. One of the most frequent complaints is the loosening of the implant caused by the failure of the adhesive bonding to secure it to the patient’s existing bone.
  
• the ExploR Modular Radial Head System - this implant reproduces the natural articulation of radio-capitellar and radio-ulnar joints in the elbow. However, a lawsuit alleges it was improperly designed, manufactured and tested. Operating surgeons were not given warnings about tightness and/or torque limiters. As a result, the screw backs out into the elbow and ultimately the device fails.
  
• the Advanced Bionics Cochlear Implant - this device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. On February 17, 2020, Advanced Bionics distributed an “Urgent Field Action Notification” to healthcare providers noting the company had detected an increase in the number of devices being explanted or having the potential of being explanted due to hearing performance degradation issues and other problems.

If you’ve been hurt.

If you or a loved one have experienced an unexpected adverse medical outcome that results in a serious personal injury, it is generally worth your time to investigate what happened. In some cases, it is obvious that a medical device malfunction or failure is likely the cause of the problem. However, in other cases it may not become evident until experts have reviewed your medical records or until you learn that other patients have experienced similar outcomes after using a medical device.

In other cases, problems related to a medical device malfunction may not yet be apparent. If the device manufacturer or Health Canada issues a recall notice or if you receive information that a specific medical device used to test or treat you has been discovered to be faulty, you may be advised to seek medical attention to determine if there is cause for concern.

For a medical device malfunction lawsuit to be successful, generally a plaintiff must prove several elements:

• they were owed a duty of care by the defendant related to the device.
  
• the specific medical device used on them was defective by design, manufacture, marketing or through negligent maintenance.
  
• the device caused or contributed to tangible harm/damage that they experienced.
  
• the harm/damage was reasonably foreseeable.

The duty of care of a device manufacturer and/or the person or entity responsible for the device’s maintenance is usually fairly straightforward. Establishing the device itself was defective or malfunctioned may be more complicated depending on the specific facts of the case. Recalls of devices often help a plaintiff to prove it was likely faulty or prone to malfunction. Determining that a medical device’s malfunction was related to improper maintenance may be more difficult.

Linking the medical device directly to a person’s injury or damages may be relatively straightforward or more challenging. For example, if a defective medical implant requires surgery for removal and/or replacement, a plaintiff can clearly demonstrate damages. However, if a medical device used for diagnostic purposes malfunctioned, the plaintiff would need to prove it caused or contributed to misdiagnosis or delayed diagnosis that resulted in harm or damages they would have not otherwise experienced. Often medical experts are called upon to offer their assessment of what factor(s) likely led to a person’s injury.

Contact an experienced medical device malfunction lawyer.

The complexity that is a part of many medical device malfunction cases can seem daunting. Choosing a knowledgeable, skilled and experienced personal injury lawyer to represent you can provide reassurance that your case is in good hands.

As one of the country’s top-ranked personal injury firms, Gluckstein Personal Injury Lawyers has earned a reputation for our ability to handle these types of matters. Keenly aware of our extensive network of experts and our extensive experience with medical device malfunction cases, we often receive referrals from other lawyers. With a strong reputation for achieving results for our clients, Gluckstein Personal Injury Lawyers is ready to help you in any way we can.

When you call for a no cost, no obligation initial consultation, we will listen to your story, explain your legal rights and outline your various options. If we believe in the prospects for your being compensated through a negotiated settlement or a favourable judgment at court, we will offer to become your trusted legal representative and advocate.

Committed to providing full-circle care, at Gluckstein Lawyers we treat our clients as we would treat our own family. Our compassionate client liaisons - some of whom had experienced their own personal injury cases - are available to help guide you through the legal process, to answer any questions you may have, and to simply check in to see how you are doing as you take steps to rebuild your life after a terrible loss.

Gluckstein Personal Injury Lawyers believe a person’s financial resources should never be a barrier to justice. As we work on contingency, we’ll cover all court costs and will only ever accept payment for our services if we are able to negotiate a fair settlement or win an award in court.

With so much to gain and so little to lose, choose a path forward where you can be confident you will have a fierce advocate on your side and by your side. Contact Gluckstein Personal Injury Lawyers today to learn more about what we can do for you.