Facts

Nicole Vieira and Emilia Barozzi filed a lawsuit against Mentor Worldwide over complications they suffered after they were implanted with Mentor's MemoryGel Silicone Breast Implants.

PLAINTIFF'S CONTENTIONS: Plaintiffs contended that they suffered extreme illness after they were implanted by defendant's breast implants. They contended that their symptoms included joint pain, memory loss, cognitive dysfunction, itching, nausea, dizziness, shortness of breath, and muscle weakness. Plaintiffs contended defendant was strictly liable for their injuries because it manufactured the implants.

DEFENDANT'S CONTENTIONS: Defendant contended it was not liable because plaintiffs' state law tort claims were preempted by the federal Food and Drug Act. Defendant filed a Rule 12(b)(6) motion to dismiss for failure to state a claim.

Result

The court granted defendant's Rule 12(b)(6) motion on the grounds that the FDA expressly preempted the state law products liability claim. The court dismissed the case with prejudice, declining to remand or allow leave to amend because the FDA requires manufacturing defect claims to be brought by, and in the name of, the United States.