Also known as: adequate warnings · adequately warn · adequately warned · adequately warning · sufficient warning
Written by attorneys — see sources below.
A warning that reasonably alerts a product's average user to a potential hazard and fairly conveys the nature and extent of the danger. It must be displayed prominently and include notice of the hazard's existence, a description of its nature and possible consequences, and instructions on how to avoid it.
Arcadia Retail placed bright signs and labels on its ladders warning users not to stand on the top rung. When a customer ignored the signs and fell, the court held that the warnings satisfied the duty of care because they were reasonably calculated to reach users and convey the risk.
Azure Solutions supplied its prescription pain medication with detailed risk information sent directly to prescribing doctors. When a patient suffered side effects, the court ruled the manufacturer had no liability to the patient because the warnings to the physician were complete and the physician exercised independent judgment.
Alliance Holdings distributed updated safety data sheets about its chemotherapy drug to oncologists nationwide. A patient later claimed inadequate warning, but the court held the duty ran only to physicians as learned intermediaries, so the manufacturer satisfied its obligation by informing the medical community.
Anchor Bank faced prosecution under a state obscenity law for distributing certain materials. The court upheld the conviction because the statute's language gave adequate warning of the prohibited conduct when measured by common understanding, satisfying due process requirements.
Roth conducted a business in New York in the publication and sale of books, photographs and magazines. He used circulars and advertising matter to solicit sales and was convicted by a jury in the District Court for the Southern District of New York upon 4 counts of a 26-count indictment charging him with mailing obscene circulars and advertising, and an obscene book, in violation of the federal obscenity statute. His conviction was affirmed by the Court of Appeals for the Second Circuit. Alberts conducted a mail-order business from Los Angeles. He was convicted by the Judge of the Municipal Court of the Beverly Hills Judicial District, having waived a jury trial, under a misdemeanor complaint which charged him with lewdly keeping for sale obscene and indecent books, and with writing, composing and publishing an obscene advertisement of them, in violation of the California Penal Code. The conviction was affirmed by the Appellate Department of the Superior Court of the State of California in and for the County of Los Angeles. The Supreme Court granted certiorari in the Roth case and noted probable jurisdiction in the Alberts case.
View caseAndre Antoine was arrested and questioned without being told of his right to remain silent. The court suppressed his statements because the absence of an adequate warning about the privilege against self-incrimination violated constitutional protections.
In March 1963 Ernesto Miranda was arrested at his home in Phoenix and taken to the police station where he was identified by the complaining witness. He was then questioned by two officers in Interrogation Room No. 2 for two hours. The officers did not advise him of any right to counsel. Miranda signed a typed confession that was introduced at his trial for kidnapping and rape. On October 14 1960 Michael Vignera was arrested in connection with a Brooklyn robbery. He was taken first to the 17th Detective Squad headquarters in Manhattan and later to the 66th Detective Squad. A detective questioned him for several hours without any advice concerning counsel. Vignera made an oral admission. He was then questioned by an assistant district attorney whose transcribed statement was also introduced at his trial for first-degree robbery. On March 20 1963 Carl Calvin Westover was arrested by Kansas City police as a suspect in two local robberies. Kansas City police interrogated Westover on the night of his arrest. The next day local officers interrogated him again throughout the morning. Westover was then turned over to FBI agents who questioned him for two to two-and-a-half hours about California robberies and obtained signed confessions. At the time the FBI agents began questioning Westover he had been in custody for over fourteen hours. On January 31 1963 Roy Allen Stewart was arrested at his home in connection with a series of purse-snatch robberies. During the next five days police interrogated Stewart on nine different occasions without any advice of rights. On the ninth session Stewart confessed. Transcripts of the interrogations were introduced at his trial for kidnapping rape and murder. The Arizona Supreme Court affirmed Miranda's conviction. The New York courts affirmed Vignera's conviction. The Ninth Circuit affirmed Westover's conviction. The California Supreme Court reversed Stewart's conviction. The Supreme Court granted certiorari in the four cases and consolidated them for argument.
View caseAnita Ali received Phenergan by direct arterial injection and suffered severe injury. The court held that the manufacturer's FDA-approved label provided an adequate warning of the known risks, so federal law did not preempt the state failure-to-warn claim on these facts.
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.
View caseA warning to the prescribing physician satisfies the duty when it is adequate and not misleading. The physician's independent judgment then breaks the causal chain to the patient unless the warnings themselves were deficient.
Supporting sources
The warning must exercise reasonable care, reach the endangered area, and address risks that arise from the absence of warning. It prevents a finding of negligence when the actor's interest in the act is paramount or the risk stems solely from lack of notice.
Supporting sources
…fear, effectively, and in a way that eliminates the evils in the interrogation process. Without the protections flowing from adequate warnings and the rights of counsel, "all the careful safeguards erected around the giving of testimony, whether by an accused or any other witness, would become empty formalities in a procedure…