Critical Medical Device Series: Part V Mitigating Litigation Risks for AI-Enabled or Assisted Medical Devices

The number of artificial intelligence- and machine learning-enabled medical devices being used in the healthcare industry is increasing by the month, with the U.S. Food and Drug Administration having already authorized over 1,000 such devices for use. These innovative devices undoubtedly present potential product liability issues that device companies will face from the plaintiffs’ bar who are increasingly looking to device manufacturers over other parties to recover for alleged injuries sustained by their clients.

Arnold & Porter partner Julie du Pont and counsel Rachel Forman and Jocelyn Wiesner will focus on discussing the product liability litigation risks of these emerging technologies, company best practices for risk mitigation, and how the regulatory guidance and landscape give insight into potential theories of liability. Whether your medical device company has a large or limited product liability litigation portfolio or is using or plans to use artificial intelligence/machine learning for its medical devices, this presentation will enable the company’s legal team to spot issues and mitigate risks before litigation begins and defend against filed claims.