Paraguard Litigation with Marcus Susen

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.

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.

Easterby's candor opens up the conversation around the burden birth control places on women and how we can change this through legal support.

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.

Key Topics:

Differences between the 3 classes of medical devices. Criteria for Paraguard client intake. The FDA’s conflicted relationship with big pharma. Essure litigation process and the impact of women taking action themselves. Allergan Biocell breast implants currently under recall and the signature injury caused by these implants.

Quotes:

“In essence, we're seeing that a lot of the Paraguard devices, which is an IUD breaking off on removal, causing significant issues” (00:59 Susen)

“Devices are usually categorized as class one, class two, or class three, depending upon essentially their risk. Class one being the low-level risk class, three being the high-level risks, such as pacemakers. The class three medical devices have what they call pre-market approval, where they go through a very high-level pre-market approval process they're meant to be for life-saving devices.” (2:03 Susen)

“They regulate it as a drug, but the problems that we're seeing today are device problems” (3:25 Susen)

“So many of these torts are woman-centric, reproductive centric issues. When you go to a nurse or doctor and you say something's not right, you're discredited.” (5:05, Easterby)

“There is no other cause for this specific type of cancer, other than this breast implant” (15:28, Susen)