Latest in Medical Devices Litigation

The landscape of medical device litigation has seen significant developments in recent years, marked by notable court rulings and regulatory changes. This article provides a factual overview of key cases and their implications for the medical device industry.

Notable Court Rulings

1. In re DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (2013)

   • Summary: This multidistrict litigation involved claims against DePuy Orthopaedics for design defects and failure to warn regarding its ASR hip implant devices. Plaintiffs alleged that the devices were prone to failure within a few years of implantation, leading to pain, mobility issues, and the need for revision surgeries.

   • Outcome: The case resulted in a $2.5 billion settlement to compensate patients who had undergone revision surgeries due to the defective implants.

   • Implications: This case highlighted the risks associated with implantable medical devices and the importance of rigorous pre-market testing and post-market surveillance.

2. Ethicon, Inc. v. Carlene Kondyne (2018)

   • Summary: This case addressed the preemption doctrine in the context of transvaginal mesh products. The plaintiff, Carlene Kondyne, claimed that the mesh product was defectively designed and that Ethicon failed to warn of the risks.

   • Outcome: The court ruled that the plaintiff's state-law claims were not preempted by federal regulations, allowing the case to proceed. This decision was significant in the context of medical device litigation, as it opened the door for similar state-law claims to be brought against manufacturers of federally approved devices.

   • Implications: The ruling underscored the potential for state-law claims to survive preemption challenges, emphasizing the need for manufacturers to ensure their products are safe and that they provide adequate warnings about potential risks.

3. Medtronic, Inc. v. Lohr (1996)

   • Summary: This Supreme Court case established that the preemption doctrine does not apply to medical devices cleared through the FDA's 510(k) process, as opposed to those that undergo the more rigorous premarket approval (PMA) process.

   • Outcome: The Court held that state-law claims were not preempted for devices cleared under the 510(k) process, allowing the plaintiffs to proceed with their claims against Medtronic for a defective pacemaker.

   • Implications: This landmark decision has had a lasting impact on medical device litigation, particularly in clarifying the scope of preemption for devices that have not undergone PMA.

Regulatory Changes for Medical Devices Impacting Litigation

The FDA has introduced several regulatory changes aimed at enhancing the safety and oversight of medical devices. These include:

Expansion of the 510(k) Clearance Pathway

Date: August 1, 2019

The FDA expanded the 510(k) clearance pathway, allowing for a faster market entry for certain low-to-moderate risk devices. This change facilitates quicker access to the market while maintaining safety and effectiveness standards. The 510(k) pathway now includes more stringent requirements for demonstrating substantial equivalence to a predicate device, focusing on up-to-date technological advancements and clinical performance.

Relevant Guidance Documents:

• "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (July 28, 2014)

• "Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)" (September 29, 2009)

Implementation of the Unique Device Identification (UDI) System

Date: September 24, 2013

The FDA implemented the Unique Device Identification (UDI) system to improve the traceability of medical devices. This system assigns a unique identifier to each device, enhancing post-market surveillance and enabling more efficient recalls and adverse event reporting. The UDI system is designed to provide a consistent and standardized way to identify devices throughout their lifecycle.

Relevant Guidance Documents:

• "Global Unique Device Identification Database (GUDID)" (June 27, 2014)

• "UDI Requirements for Medical Devices" (November 14, 2016)

Letters and Notices:

• "Letter to Device Labelers: Reminder to Comply with UDI Requirements" (August 20, 2018)

Increased Focus on Cybersecurity for Connected Medical Devices

Date: October 1, 2018

The FDA has heightened its focus on the cybersecurity of connected medical devices. This initiative includes issuing guidance on managing cybersecurity risks during the design, development, and post-market phases. The guidance outlines best practices for manufacturers to mitigate potential cybersecurity threats and ensure patient safety.

Relevant Guidance Documents:

• "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2, 2014)

• "Postmarket Management of Cybersecurity in Medical Devices" (December 28, 2016)

Letters and Notices:

• "Letter to Industry: Strengthening Cybersecurity Practices in Medical Device Development" (January 15, 2019)

Conclusion

The recent developments in medical device litigation and regulation reflect an evolving landscape where patient safety, technological innovation, and legal accountability intersect. Notable court rulings have clarified the application of the preemption doctrine and highlighted the potential liabilities for manufacturers, while regulatory changes aim to enhance the safety and oversight of medical devices. As the industry continues to evolve, stakeholders must navigate these complexities to balance innovation with the imperative of patient safety.

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Read: Medical Devices Lawsuits- A Guide for Plaintiffs