To survive express and implied preemption, a state law claim against a medical device manufacturer must allege a claim that is based on conduct that violates the Federal Food, Drug and Cosmetic Act but is wholly based on state law which would give rise to recovery even if the federal act did not exist. Here, plaintiff’s claims of negligence and strict liability for manufacturing defects in breast implants and failure to warn thd FDA of adverse reactions to the breast implants met those standards, as did a claim for negligence per se in failing to follow FDA manufacturing and reporting requirements.  The plaintiff’s complaint also adequately alleged that the auto-immune type symptoms she suffered from (and which stopped once the implants were removed) were caused by the manufacturing defects and that but for defendant’s failure to warn the FDA she would have had the implants removed sooner and thus suffered for a shorter time.