Gregory Hong is an IPilogue Writer and a 1L JD candidate at Osgoode Hall Law School.

This past summer, I had the privilege, as my final act as a graduate student, to attend a major magnetic resonance imaging (MRI) conference in London, UK (ISMRM). At this conference, GE Healthcare used its plenary session to . The other major MRI manufacturers, and , also have AI suites. Computed tomography (CT) had joined the AI party even earlier than MRI, with , , and products. The widespread adoption of AI in medical imaging products is significant because it is one of the first commercial applications of AI in healthcare.

What are MRI and CT?

MRI and CT are the workhorses of most hospitals’ radiology departments. CT and MRI both allow for a 3D image to be taken of internal anatomy, making them invaluable for diagnosing many diseases. Unfortunately, they both have at least one critical downside. CT is an extension of x-ray and thus exposes patients to ionizing radiation, with a CT image often depositing more than 10x the effective radiation dose of an x-ray image. MRI is lauded for, among other benefits, avoiding this radiation; however, MRI is both expensive to run and comparatively very time-consuming.

How does AI come into play?

The primary goal of AI in MRI and CT applications is mitigating the downsides – radiation dose in CT, and scan time in MRI. In both cases, this goal is achieved by “training” an AI through machine learning – or, more specifically, deep learning algorithms – by feeding it an enormous amount of data consisting of previously acquired images. Trained AI allows MRI and CT to acquire less data as the AI is used to fill in the data shortfall – almost analogous to the Hollywood idea of zooming in on a pixelated picture and seeing a clear image. Acquiring less data means less views in CT, leading to less radiation dose and shorter MRI scan times. The resulting AI-enhanced images are used for diagnostic purposes in the same way that conventionally acquired images are.

Why does it matter?

Directly related to healthcare, Canadian , and any improvements to MRI and CT will aid in alleviating that pileup to some extent. It is also significant that radiologists and medical physicists approve of AI in diagnostic imaging. There may not be any group in the medical field more qualified to have at least some grasp of the (disclaimer: I do not fully understand the title of this thesis). It also represents one of the first applications of AI that directly affects medical decisions, which may open the door for other AI applications in healthcare. Lastly, using AI in a commercially available product is interesting on its own – the pathway toward deploying AI in such a high-stakes application may be a useful example for future AI-based products.

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Gregory Hong is an IPilogue Writer and a 1L JD candidate at Osgoode Hall Law School,

Many of you are likely familiar with 3D printing. The process is as follows:

1. Add a digital model of a 3D model to a slicer;
2. The slicer “slices” the model and generates toolpaths layer by layer;
3. Upload the toolpaths to the 3D printer; and
4. Start the machine and wait!

Within hours, you will have a physical rendition of the object you modelled. During the early days of the pandemic, supply issues forced society to adopt any available means to source medical supplies. 3D-printing was able to fill some of the supply gaps faced in medicine, in an important but limited capacity.  It began with simpler things like  face shield holders, but over time, the 3D-printing community expanded its applications to things like , , and even a whole .

A mounting concern, however, was that the ability for anyone to download a physical 3D object may pose problems for IP rights. While the pandemic made it , it was important to consider possible avenues to ensure that IP does not hinder emergency response.

I will summarize here two published views on existing solutions to this IP problem: in a May 2022 article in The Journal of World Intellectual Property, explored exceptions that potentially allow IP to be freely used in emergencies: the right to repair exception, the private and noncommercial use exception, and the experimental use exception, while in a in International Review of Intellectual Property and Competition Law (IIC), Ballardini et al. examined two existing ways to tackle the problem: compulsory licensing and voluntary licensing.

Compulsory licensing is the straightforward authorization of licensing by force outlined in the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights . It is regarded, as it should be, as a last resort — administrative burdens make this route largely unviable as a fast way to enable and deploy an emergency response. Voluntary licensing, then, should be  the best existing means of promoting patented ideas in an emergency. Ballardini et al. looks specifically at IP pools and IP pledges as successful means in the response to the pandemic. Two very important examples of IP pools include the and the , which includes 3D-printing repositories. An IP pledge is effectively a patent holder announcing a limited-time public license of their patent. A prominent example of this is the , where many large technology companies have pledged “to make our intellectual property available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.” While IP pledges are powerful tools, it is still limited by patent holder goodwill. This is a problem because pledges are conditional and limited in scope, leading to confusion and uncertainty.

The right to repair exception is the right of an owner of a patented article to make repairs to preserve its useful life. Abbas argues that “A more robust and explicit right to repair exemption needs to be incorporated in patent law in response to the COVID-19 health emergency… This clear exemption is important so that consumers of medical devices and 3D maker communities can confidently engage in humanitarian efforts to repair critical life-saving medical equipment without risking patent infringement.”

The private and noncommercial use exception varies and is generally intended to prevent a patentee’s rights from restricting non-commercial activities that don’t conflict with the legitimate interests of the rights holder. Abbas also asked WTO Member-States to “adopt a reasonably broad noncommercial use exception to make it practically significant,” so as to allow medical device users to repair their devices without undue concern for IP problems.

The experimental use exception exists to support the advance of science and technology. Unfortunately, in Madey v. Duke, the Court  limited this exception’s scope significantly. Furthermore, as a common-law rule, experimental use is not defined by international agreement. Abbas calls for WTO members to clarify the experimental use defense and extend coverage to repairs, arguing that “facilitating increased experimental and repair activity by creating a safe harbor for experimentation with medical devices will better prepare countries to deal with a future pandemic.”

The pandemic has shown possible benefits to relaxing patent enforcement in emergency situations. It is thus imperative to explore how the IP system can avoid standing in the way of saving lives. The ideas outlined by Ballardini et al. and Abbas are a start – hopefully more ideas will be expressed and adopted going forward.

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A defective medical device is any object used for medical purposes that has an existing flaw or errs in a manner that can harm patients. Essential medical devices that are defective injure or impair thousands of patients and medical operators every year, so it's important that you know the risks.

What Common Medical Devices Can Be Defective?

Types of defective medical devices can include:

• Surgical instruments
• Surgical robots
• Laser eye surgery devices
• Pacemakers
• Implants
• Hernia, pelvic, or any other internal mesh
• Metal hips or other prosthetic devices
• Hearing aids
• Contraceptives

A common defect in many medical devices is electrical outages, which can impact pacemakers, for example. Electrical failures may be responsible for a range of problems with other internal devices as well, but primarily are a problem during operations that utilize precision machinery.

Medical defects can also include ruptures or other breaks that cause the device to stop working or harm the user. Silicone implants, if not replaced after a certain number of years, may leak or even pop. Metal hips or contraceptive inserts can also fracture, causing complications.

What Kind of Harm Can Come from a Defective Medical Device?

At the most severe, a , as pacemakers are essential for maintaining a fully functioning beating heart. Even more common is a defect that interrupts a lifesaving or otherwise critical surgical procedure. In the case of brain or heart surgery, surgical robot failure can lead to a misplaced incision, possibly causing complications or death. A defective laser during eye surgery may prove equally catastrophic.

Breast implants that rupture can cause serious consequences if they are made of silicone and leak beyond the scar tissue to other parts of the body. While saline implant fluid is largely harmless, silicone gel cannot be absorbed by the body. A small or silent leak that doesn’t change external shape or appearance can cause significant complications, the least of which requires corrective surgery to replace the implant.

In the past decade, the US Food and Drug Administration (FDA) reportedly received near 5.5 million adverse impact reports regarding medical devices. Over 10 percent of the reports involved an “explant”, referring to the operation to remove an implanted device.

Technology continues to advance, and implants are becoming more common all the time for a variety of different functions. Unfortunately, this has predictably corresponded with a rise in the number of medical defects.

Surgical failures involving defective instruments are the greatest risk to human health. This is because surgical instruments often don’t undergo as much testing in the field as other medical devices, given the relative limitations of their use.

Recalls and Regulations

The FDA issues a nationwide recall whenever a medical device is proving consistently defective, ranging in severity across three recall classes and issued as either corrections or removals. The FDA also issues routine communications, which one can check if they have uncertainty about the safety of a potential class or brand of medical devices.

Who is Liable When a Medical Device Is Defective and Causes Harm?

The safety of certain medical devices has been seriously questioned in recent years, particularly specific forms of implants that can lead to complications or rupture far too easily.

Lawyers are stepping in to a chance of financial relief for victims. When a medical device is defective and causes harm to a patient, that patient may qualify for a product liability claim, which involves a suit against the manufacturer or distributor of the product.

In cases where an individual has been harmed as the result of a product defect, a product liability claim is generally the only path available to financial compensation. A defective product is not a case for medical malpractice. However, if the malfunction is due to improper maintenance, there could be a case of negligence against the hospital.

Class action lawsuits are common in defects that are widespread and lead to a recall, as dozens, hundreds, or even thousands of victims may be eligible to claim damages.

If you have been injured by a faulty medical device, it is wise to seek legal counsel to help with your case. When looking for an attorney, cross-search between lawyers and the defective product in question. There may be qualified attorneys who have had experience with the same medical device, which means they will have a head start on your case from the beginning.

For innovators, legal protection may also prove critical for the continued fostering of your own progress in medical research and the furtherance of lifesaving medical device research and development.

Written by Kyle Hambright, guest editor who enjoys writing on the vast and complex field of personal injuries. 

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