What Went Wrong And When? A Framework For Assessing Medical Device Product Liability and Patient Safety.

Establishing liability is always critically important in personal injury law. In many cases, determining who is responsible for a person’s injuries is straightforward. But when a medical device is involved, some additional sleuthing may be required.

If a person is injured by a medical device, the list of potentially negligent parties can be lengthy. The medical device manufacturer, regulatory body, distributor, purchaser, healthcare practitioners, healthcare facilities and staff, or patient could all have a role to play in what went wrong.

Was the product not only safe to use, but safe for the individual patient to use? Was there a design flaw? An error in the manufacturing process? Damage during distribution? Improper use? Lack of training? Poor maintenance and storage? Were there factors unique to the patient that made this device unsafe for them specifically? Did more than one thing go wrong between a medical device’s design and its end use? These are questions a plaintiff and their lawyer will want to answer as they prepare to launch a civil action.

In this blog post, I’d like to outline a simple, easily adaptable three-step process for assessing liability in medical device cases. Using Endean et al. v St. Joseph’s General Hospital, 2017 ONSC 2632 (CanLII) as a case study, I’ll demonstrate how this framework can be used retroactively to find fault when there is a negative patient outcome involving a medical device. I conclude by explaining how this three-step process reduces litigation expenses that could otherwise eat into a patient’s settlement or court award for damages.

Product Safety Versus Patient Safety.

Distinguishing between product safety and patient safety is an important part of the three-step medical device liability framework.

If a medical device is linked with an adverse outcome in a patient, does that mean it is fundamentally unsafe? No. A safe product is necessary for safe patient outcomes, but product safety does not always guarantee these results.

Step One concerns product safety, while Steps Two and Three focus on patient safety. In short, product safety is established through regulatory approvals, while patient safety is determined by proper use and proper management/maintenance of the medical product. 

Problems can arise at any step and, as Endean et al. shows, at every step.

Step One: Did the Product Meet Regulatory Criteria?

When a medical product has been examined by the proper regulatory body and approved (based on specific criteria), it is deemed safe and effective for use. The end user of the device could be a doctor, nurse, technician, other hospital staff, or even the patient (for example, someone who uses a syringe for insulin injections is operating a medical device).

Anyone involved in the research, purchase, acquisition, and operation of a medical device must ensure it complies with the applicable regulatory requirements.

In the Endean et al. case, medical implants were acquired by a hospital after Canada’s Medical Device Regulations were amended in 1983. These amendments required a Notice of Compliance from the regulator, assuring that the device had demonstrated evidence of safety and efficacy - criteria not met in this case.

The plaintiffs in the case, who sustained serious and catastrophic injuries, made claims against the hospital and oral surgeons (as the device manufacturer and distributor were both bankrupt and not parties to the action). The trial judge found the hospital liable for failing to ensure the product had regulatory approval prior to use.

Step Two: Is the Medical Device Safe for Use in the Specific Context?

Beyond ensuring there is regulatory approval for product safety, liability can arise if the device is unsafe to use in a given context. A person must consider unique conditions, environmental factors, and human factors when assessing if a medical device is safe for a patient to use.

Some content-specific questions to pose include:

  • Does the medical device operate safely given the specific temperature, humidity, lighting, and other environmental factors of a particular context?
  • Is knowledge and/or training required to use the device safely? Do experience and technical ability have a bearing on the safe use of a given medical device?
  • If there are unique contextual factors that may affect the safe use of a medical device, was the patient advised of these risks and did the patient provide informed consent?

The oral surgeons in Endean et al. were found to be negligent in their duty to take care when assessing its viability for use in the patients in a given context. Warning signs available in 1983 indicated that a proplast Teflon implant would fail in a patient’s temporomandibular joints. Pressure on the device generated wear debris that caused catastrophic injuries to the plaintiffs.

Step Three: What is Required for the Safe Use and Management of a Medical Device?

To be safe for patient use, medical devices must be properly managed, maintained, disposed of, and replaced. The following factors should be considered:

  • What conditions required for the continued safe use of a particular medical device have been identified by the manufacturer and disclosed to any learned intermediaries and the patient?
  • What is required for physical device maintenance and records management?
  • Is storage sufficient to ensure the safe continued use of the medical device?
  • Is there appropriate monitoring, investigating and reporting of any adverse events?
  • If problems have been discovered with a medical device, how are patients warned?
  • What safeguards are in place for ensuring the medical device is replaced before its expiry and disposed of once it reaches the end of its lifespan?

In Endean et al., a worldwide recall of the device in 1990 was not communicated to the patients until 1994 at the earliest. In the intervening period, the damage caused by deteriorating implants worsened and led to catastrophic outcomes, increasing the injuries and, correspondingly, the damages awarded.

Save Time, Money, and Patient Health.

When a patient is injured by a medical device, trying to determine who is wrong and for what can be challenging. It often leads to a “shotgun” approach where an action identifies all stakeholders as defendants. Such an approach is not desirable. It raises litigation expenses and can needlessly complicate an action.

Using this simplified three-step framework for assessing what went wrong with a particular medical device and where the corresponding liability may lie can save time and money. If hospitals and medical staff adopt this framework to better ensure product and patient safety, they can eliminate or reduce their own liability for personal injuries, and potentially save their patients from experiencing preventable adverse outcomes.

If you or a loved one has suffered a serious injury due to a medical device, please contact me today.


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