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Charles Riegel underwent coronary angioplasty in 1996 shortly after suffering a myocardial infarction. His right coronary artery was diffusely diseased and heavily calcified. Riegel's doctor inserted an Evergreen Balloon Catheter manufactured by Medtronic, Inc. into the artery in an attempt to dilate it. The catheter had received premarket approval from the FDA in 1994, with changes to its label receiving supplemental approvals in 1995 and 1996. The device's labeling stated that use was contraindicated for patients with diffuse or calcified stenoses and warned that the catheter should not be inflated beyond its rated burst pressure of eight atmospheres. Riegel's doctor inflated the catheter five times to a pressure of ten atmospheres, and on its fifth inflation the catheter ruptured. Riegel developed a heart block, was placed on life support, and underwent emergency coronary bypass surgery. In April 1999 Riegel and his wife Donna brought suit in the United States District Court for the Northern District of New York. Their complaint alleged that Medtronic's catheter was designed, labeled, and manufactured in a manner that violated New York common law and that these defects caused Riegel to suffer severe and permanent injuries. The complaint raised claims of strict liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter. The District Court held that the MDA pre-empted Riegel's claims of strict liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter. It also held that the MDA pre-empted a negligent manufacturing claim insofar as it was not premised on the theory that Medtronic violated federal law. The court concluded that the MDA pre-empted Donna Riegel's claim for loss of consortium to the extent it was derivative of the pre-empted claims. The District Court later granted summary judgment to Medtronic on the remaining claims. The United States Court of Appeals for the Second Circuit affirmed these dismissals. The Riegels petitioned for certiorari. The Supreme Court granted review to resolve a conflict among the Courts of Appeals regarding the scope of the MDA's pre-emption provision. Charles Riegel having died, Donna Riegel is now petitioner on her own behalf and as administrator of her husband's estate.

Vernonia School District 47J operates one high school and three grade schools in the logging community of Vernonia, Oregon. In the mid-to-late 1980s, teachers and administrators observed a sharp increase in drug use among students. Between 1988 and 1989 the number of disciplinary referrals in Vernonia schools rose to more than twice the number reported in the early 1980's. A Vernonia high school football coach had observed suspicious steroid use by his athletes. The District's wrestling coach had witnessed students sharing steroids and had discovered steroids in a school locker. The District had a drug testing policy for student athletes since before 1989, but it had not been enforced for lack of funding. In the fall of 1989, the District received funds for a drug testing program and approved a Student Athlete Drug Policy. The Policy authorized random urinalysis drug testing of students who participated in the District's athletic programs. The Policy applied to all students participating in interscholastic athletics. It required students and their parents to sign a consent form agreeing to drug testing as a condition of participation. Athletes were tested at the beginning of the season and then randomly throughout the season. The testing procedure required students to provide a urine sample in a bathroom stall with an adult monitor of the same sex standing outside the stall. The monitor listened for normal sounds of urination. The samples were sent to a laboratory for analysis. A positive test result led to a meeting with the student and his or her parents. The student was given the option of participating in a drug assistance program or being suspended from athletics for the remainder of the season and the next season. In the fall of 1991, respondent James Acton, who was then a seventh grader, signed up to play football at the District's middle school. He was denied participation because he and his parents refused to sign the consent form for drug testing. They then filed this suit in the United States District Court for the District of Oregon, seeking declaratory and injunctive relief from enforcement of the Policy on the grounds that it violated the Fourth and Fourteenth Amendments to the United States Constitution and Article I, § 9, of the Oregon Constitution. After a bench trial, the District Court dismissed the suit on the merits. A panel of the Court of Appeals for the Ninth Circuit reversed, holding that the Policy violated both the Federal and the State Constitutions. The Supreme Court granted certiorari.

Diana Levine, a professional musician, was treated for a migraine headache at a Vermont clinic on April 7, 2000. She received an intramuscular injection of Demerol and Phenergan that provided no relief, so she returned later that day and received a second injection of both drugs administered by the IV-push method. The injection entered an artery, either because the needle penetrated an artery directly or because of perivascular extravasation, and Levine developed gangrene that required amputation of her right hand and then her entire forearm. Levine settled claims against the health center and clinician before bringing a product liability action against Wyeth in Vermont state court. She alleged that Phenergan's labeling was defective because it failed to instruct clinicians to use the IV-drip method of intravenous administration instead of the higher-risk IV-push method. After a five-day jury trial, the jury found Wyeth negligent and that Phenergan was a defective product as a result of inadequate warnings and instructions, awarding total damages of $7,400,000 that the court reduced to account for the prior settlement. Wyeth manufactures Phenergan, an antihistamine used to treat nausea that the FDA first approved in 1955. The injectable form can be administered intramuscularly or intravenously, either by the IV-push method of injecting the drug directly into a vein or by the IV-drip method of introducing it into a saline solution in a hanging intravenous bag. The drug is corrosive and causes irreversible gangrene if it enters a patient's artery. The FDA-approved labeling warned of the danger of gangrene and amputation following inadvertent intra-arterial injection but did not contain a specific warning about the risks of IV-push administration. The trial record contained correspondence between Wyeth and the FDA about Phenergan's label spanning from the 1955 approval through a 1981 supplemental application that the FDA finally approved in 1998. In 1987 the FDA suggested different warnings about the risk of arterial exposure, and Wyeth submitted revised labeling in 1988, but the FDA did not respond and in 1996 instructed Wyeth to retain the verbiage in the current label regarding intra-arterial injection. The record also showed at least twenty incidents prior to Levine's injury in which a Phenergan injection resulted in gangrene and amputation. The trial court denied Wyeth's motion for summary judgment asserting federal preemption. The Vermont Supreme Court affirmed the jury verdict. The Supreme Court of the United States granted certiorari to decide whether the FDA's approvals of Wyeth's drug label precluded Levine from bringing her claim.

In 2001 Boston police officers received a tip that a Kmart employee was engaging in suspicious activity involving repeated short trips in a blue sedan. Officers set up surveillance in the parking lot, observed the described sequence of events, detained the employee upon his return, and discovered four clear plastic bags containing a substance resembling cocaine. The officers then arrested the two men in the car, one of whom was petitioner Luis Melendez-Diaz. The officers placed all three suspects in a police cruiser. During the short drive to the police station the officers observed their passengers fidgeting and making furtive movements in the back of the car. After depositing the men at the station they searched the police cruiser and found a plastic bag containing nineteen smaller bags hidden in the partition between the front and back seats. The officers submitted the seized substances to the State Laboratory Institute of the Massachusetts Department of Public Health, which was required by law to conduct chemical analysis upon police request. Analysts at the laboratory performed the tests on November 28, 2001, and prepared three certificates of analysis that reported the weight of the bags and stated that the substance was found to contain cocaine. Each certificate was sworn before a notary public by the analysts, as required under Massachusetts law, and reprinted the statutory provision making the certificates prima facie evidence of the composition, quality, and net weight of the narcotic analyzed. Melendez-Diaz was charged with distributing cocaine and trafficking in cocaine in an amount between 14 and 28 grams. At trial the prosecution introduced the bags seized from the codefendant and from the cruiser along with the three certificates. Petitioner objected to admission of the certificates, asserting that Crawford v. Washington required the analysts to testify in person. The trial court overruled the objection and admitted the certificates pursuant to the state statute. The jury found Melendez-Diaz guilty. He appealed, contending that admission of the certificates violated his Sixth Amendment right to be confronted with the witnesses against him. The Appeals Court of Massachusetts affirmed the convictions, relying on a prior decision of the Supreme Judicial Court that had held forensic analysts are not subject to confrontation. The Supreme Judicial Court denied review, and the United States Supreme Court granted certiorari.

Robert J. Taylor operates a bait business in Maine. In 1984 he arranged to have 158,000 live golden shiners delivered to him from outside the State even though a Maine statute prohibited the importation of live baitfish. The shipment was intercepted. A federal grand jury in the District of Maine indicted Taylor for violating and conspiring to violate the Lacey Act Amendments of 1981, 16 U.S.C. § 3372(a)(2)(A), which criminalizes the importation of fish taken or possessed in violation of state law. Maine intervened in the District Court pursuant to 28 U.S.C. § 2403(b) to defend the constitutionality of its statute, asserting that the ban protected the State's fisheries from parasites and nonnative species that might accompany shipments of live baitfish. Taylor moved to dismiss the indictment, arguing that the import ban unconstitutionally burdened interstate commerce. The District Court conducted an evidentiary hearing before a Magistrate at which three scientific experts testified for the prosecution and one testified for the defense. The prosecution experts described two principal risks: three types of parasites prevalent in out-of-state baitfish but uncommon in Maine's wild fish population, and nonnative species that could be inadvertently included in shipments and could compete with, prey upon, or otherwise disrupt Maine's native fish. They further testified that no satisfactory inspection or sampling procedures existed for baitfish because of their small size, the large quantities shipped, and the absence of standardized techniques comparable to those developed for salmonids. Taylor's expert disputed the severity of the risks and stated that professional baitfish farmers using freshly drained ponds could largely avoid commingled species. The District Court found the statute constitutional and denied the motion to dismiss. Taylor entered a conditional plea of guilty under Federal Rule of Criminal Procedure 11(a)(2), reserving the right to appeal the constitutional ruling. The Court of Appeals for the First Circuit reversed. Maine appealed to the Supreme Court, which set the case for plenary review and postponed consideration of Taylor's challenges to appellate jurisdiction under 28 U.S.C. § 1254(2) and to Maine's standing as an intervenor. The District Court's findings rested on the Magistrate's weighing of the expert testimony, including the prosecution witnesses' statements that inspection for parasites would require destruction of the fish and that no scientifically accepted sampling methods had been developed for baitfish, as well as the absence of any estimate from Taylor's expert of the time or cost required to develop such methods.