Showing posts with label Chevron. Show all posts
Showing posts with label Chevron. Show all posts

Sunday, June 30, 2024

BROOK JACKSON: What does overturning Chevron mean? Let's consider an actual case involving FDA - Bruesewitz v. Wyeth.

Chevron Deference Aspect: The court acknowledged FDA's expertise & regulatory authority in approving & monitoring vaccines. The court implicitly deferred to the FDA's judgment that vaccines are safe & effective when they meet regulatory standards, thus preempting state law claims based on design defects. What are the implications of overruling Chevron Deference:

Courts would independently interpret the NCVIA & other relevant laws without automatically deferring to the FDA's expertise. WIN!! Brook Jackson

🚨What does overturning Chevron mean? Let's consider an actual case involving FDA - Bruesewitz v. Wyeth. Background: The case involved Hannah Bruesewitz, who suffered seizures & developmental problems after receiving a DTP vaccine manufactured by Wyeth, now a part of Pfizer. The family sued Wyeth, claiming the vaccine was defectively designed. Legal Context: The National Childhood Vaccine Injury Act (NCVIA) of 1986 established a no-fault compensation program for vaccine injury claims & removed the liability of vaccine manufacturers. The FDA's role in approving vaccines & its interpretation of safety standards were central to the case. Court's Decision: In 2011, SCOTUS ruled in favor of Wyeth, holding that the NCVIA preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. Chevron Deference Aspect: The court acknowledged FDA's expertise & regulatory authority in approving & monitoring vaccines. The court implicitly deferred to the FDA's judgment that vaccines are safe & effective when they meet regulatory standards, thus preempting state law claims based on design defects. What are the implications of overruling Chevron Deference: Courts would independently interpret the NCVIA & other relevant laws without automatically deferring to the FDA's expertise. WIN!! Plaintiffs might be more likely to challenge FDA approved vaccines in court, arguing that the FDA's safety standards or approval processes are insufficient or flawed. WIN!!
Courts would scrutinize FDA decisions more closely, likely leading to different outcomes in cases involving vaccine injuries or side effects. WIN!!

Vaccine manufacturers will face more uncertainty regarding liability & regulatory standards impacting vaccine development & availability. WIN!!