The Government’s Response to Medical Devices

The future of medical devices and the current uses of hybrid medical devices effects the way lawyers defend clients in product liability cases. As the future of medical devices continues to develop, lawyers must devise strategies to avoid preemption when dealing with lawsuits involving Class III medical devices.

The use of medical devices to solve problems within the body sometimes goes awry. With the advent of medical technologies, ample room for error exists – especially as devices are used in preliminary stages. For this reason, the federal government classifies and regulates devices in terms of the potential harm they may cause patients.

Statutory and regulatory compliance frameworks uphold medical device safety with a three-tiered classification system. The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act define this system, and medical devices are categorized as such:

• Class III – These devices pose the greatest risk to the public and, therefore, receive the most federal oversight, undergoing a more rigorous approval process.
• Class II – These are more complicated than Class I devices and undergo more regulatory controls than their safer counterparts but less than Class III devices.
• Class I – These devices are considered the safest of all categories and aren’t tied to stringent controls.

Class III medical devices are more likely to see preemption as a result of their proposed danger. Because they see more regulatory oversight, litigators should proceed with caution when offering counsel to patients who’ve undergone surgery with Class III devices.

But lawsuits involving hybrid medical devices, devices with a combination of classified components, require more strategic preparation to gain ‘wins’ and avoid preemption.

The Case of Shuker v. Smith & Nephew PLC

In the case of Shuker v. Smith & Nephew PLC, the U.S. Court of Appeals for the Third Circuit considered how to proceed with a hybrid hip case in which the plaintiff argued the device should be understood in its entirety of parts. Class II and III components composed the hip replacement device, details, the court argued, that should be considered apart from each other when classifying the device.

The plaintiff continued to argue the device was defective because of its Class III components. Relying on statutory and regulatory frameworks surrounding Class III medical devices, the court decided the plaintiff’s claims were preemptive in nature. More significantly, the court focused on the nature of the injury and the corresponding component that was primarily responsible – a Class III component.

Key Hybrid Medical Device Case Takeaways

This case highlighted several important factors regarding hybrid devices. Firstly, the court made a decision based on the mechanism of injury. The court focused on what component was specifically responsible for injury – a Class III component that ultimately dictated preemption.

Secondly, the device was used in a way not originally intended by the device manufacturer. Preemption made more intuitive sense than blaming a manufacturer who would have advised doctors to use the device in the way it was intended to be used.

The major takeaways, then, are as follows:

• Plaintiffs should be more specific with claims and diligent about doing the right research before proceeding with litigation. This way injury may be appropriately linked to Class I or II devices (instead of only Class III devices), shielding counsel and clients from preemption.
• The FDA does not regulate the practice of medicine, and it should be clearly understood how physicians use devices when determining fault. It may be more difficult to indict manufacturers if a physician is largely to blame.

Lawsuits involving hybrid medical devices become complex when multiple device components are responsible for injuries. Room for human error also clouds the process, making it potentially more difficult to place blame on manufacturers.

In order to best avoid preemption and support plaintiffs’ claims, litigators should have a more thorough understanding of all device components, showing how each part contributed to the patient’s injury. As medical devices continue to develop, more strategies will need to be put in place to avoid automatic preemption. This will require a better understanding of the roles Class I and II devices play in the mechanism of injury.