Paraguard Litigation with Marcus Susen

<p><span style="font-weight: 400;">In this episode, Leah Easterby talks with Marcus Susen, who has been involved in the Paraguard litigation. Paraguard IUDs have been breaking off during removal and causing significant issues for patients. The IUD is currently regulated as a drug, not a medical device, creating unique impacts within the litigation.</span></p> <p><span style="font-weight: 400;">Susen discusses the difference between medical devices and drugs, why Paragard is currently classified as a drug, and why this is vital for the current litigation. He explains the difference between premarket approval and 510(k) notification.</span></p> <p><span style="font-weight: 400;">Easterby's candor opens up the conversation around the burden birth control places on women and how we can change this through legal support.</span></p> <p><span style="font-weight: 400;">Susen reveals why he stuck with this case and women’s health advocacy, what FDA approval really means, and much more. This episode is not only a legal discussion, but also an insightful medical conversation that you don’t want to miss.</span></p> <p><strong>Key Topics:</strong></p> <ul> <li style="font-weight: 400;" aria-level="1"><span style= "font-weight: 400;">Differences between the 3 classes of medical devices.</span></li> <li style="font-weight: 400;" aria-level="1"><span style= "font-weight: 400;">Criteria for Paraguard client intake.</span></li> <li style="font-weight: 400;" aria-level="1"><span style= "font-weight: 400;">The FDA’s conflicted relationship with big pharma.</span></li> <li style="font-weight: 400;" aria-level="1"><span style= "font-weight: 400;">Essure litigation process and the impact of women taking action themselves.</span></li> <li style="font-weight: 400;" aria-level="1"><span style= "font-weight: 400;">Allergan Biocell breast implants currently under recall and the signature injury caused by these implants.</span></li> </ul> <p><strong>Quotes:</strong></p> <p><em><span style="font-weight: 400;">“In essence, we're seeing that a