Nicole Weber suffered severe damage to her eyesight and other injuries when an Allergan breast implant spewed silicone into her body. Nicole sued, asserting state-law, strict-product liability for a manufacturing defect. To prove that, she relied in part on res ipsa loquitur. But the Ninth Circuit approved the district court's grant of summary judgment against her because it concluded that:

(1) Nicole could not use the res ipsa loquitur doctrine to help prove a manufacturing defect. App. 9-10.

(2) Allergan's avowal in the breast-implant's labeling that over 99% of the gel would stay inside the implant did not constitute an FDA pre-market approval requirement. Thus, the right-breast implant's 2.8% silicone bleed supposedly violated no FDA requirement. App. 8, 10-13.

(3) The fact that Nicole's right-breast implant failed supposedly "does not show that Allergan failed to comply with the FDA's Current Good Manufacturing Practices." App. 14.

With that background, these are the questions for this Court:

(1) Can a plaintiff use the res ipsa loquitur doctrine as evidence that a Class III product had a manufacturing defect?

(2) Is a Class III product manufacturer's assertion of a percentage of reliability for its product in the product's labeling—which received FDA pre-market approval—an FDA requirement whose violation could support a product-liability claim?

(3) Can a manufacturing defect in a Class III product violate the FDA's Current Good Manufacturing Practices?

Can a plaintiff use the res ipsa loquitur doctrine as evidence that a Class III product had a manufacturing defect?