Diana Levine, a folk singer from Vermont, suffered from migraine headaches. She was being administered Wyeth Laboratory’s Phenergan through an IV drip. Either because the IV needle entered Levine’s artery or the drug escaped from the vein into her surrounding tissue, Ms. Levine developed gangrene. Doctors amputated her right hand and eventually her forearm. Levine could no longer work as a professional musician. Levine filed suit against both the clinic that administered the drug and Wyeth. She was awarded $7.4 million, and Wyeth appealed on the grounds that the Food and Drug Administration approval of the drug preempted state tort suits by patients. What constitutional provision is involved, and what should the court decide? [Wyeth v Levine, 555 U.S. 555 (2009)]