Also known as: ethical drugs · prescription drug · legend drug
Written by attorneys — see sources below.
A pharmaceutical product that requires a physician's prescription for lawful dispensing to patients. The classification distinguishes such products from over-the-counter proprietary medicines and subjects their distribution to physician oversight.
Emerald Enterprises manufactured an ethical drug and supplied its prescribing information to Dr. Everett. Dr. Everett reviewed the risks, exercised independent judgment, and prescribed the drug to Esther Eisenberg. When Esther later suffered an adverse reaction, the court held that the manufacturer's adequate warning to the physician broke the chain of liability to the patient.
Eclipse Manufacturing sought judicial review of an FDA regulation governing labeling of its ethical drug before the agency enforced the rule. The company argued the regulation exceeded statutory authority. The Supreme Court addressed whether the challenge was ripe for review in federal court.
In 1962 Congress amended the Federal Food, Drug, and Cosmetic Act to require manufacturers of prescription drugs to print the established name of the drug prominently and in type at least half as large as that used for any proprietary name on labels and other printed material. The underlying purpose was to inform doctors and patients that many drugs sold under trade names are identical to those sold under established names at lower prices. The Commissioner of Food and Drugs published proposed regulations in the Federal Register after receiving delegated authority, invited and considered comments from interested parties, and promulgated a regulation requiring that the established name accompany each appearance of the proprietary name on labels and in advertisements for prescription drugs, with a similar rule for advertisements. Thirty-seven individual drug manufacturers and the Pharmaceutical Manufacturers Association, whose members manufacture more than ninety percent of the nation's prescription drugs, brought suit in district court challenging the regulations on the ground that the Commissioner exceeded his statutory authority by imposing an every-time requirement. The District Court granted declaratory and injunctive relief on cross-motions for summary judgment, but the Court of Appeals for the Third Circuit reversed without reaching the merits, holding that pre-enforcement review was unauthorized and that no actual case or controversy existed. The Supreme Court granted certiorari because of the general importance of the question and an apparent conflict with a decision of the Second Circuit. The regulations were promulgated after formal notice-and-comment procedures, were made effective upon publication in the Federal Register, and carried an agency expectation of immediate compliance. Petitioners alleged that compliance would require extensive and costly changes to all labels, advertisements, and promotional materials while noncompliance would expose them to serious criminal and civil penalties.
View caseEnigma Technologies sold prescriber-identifying data concerning ethical drugs to pharmaceutical marketers. Vermont enacted a statute restricting that practice. The Supreme Court considered whether the statute violated the First Amendment rights of data sellers and pharmaceutical companies.
In 2007 Vermont enacted the Prescription Confidentiality Law, also known as Act 80, whose central provision appears at Vt. Stat. Ann., Tit. 18, §4631(d). The statute prohibits pharmacies, health insurers, electronic transmission intermediaries, and similar entities from selling, licensing, or exchanging prescriber-identifying information, and from permitting its use for marketing prescription drugs, unless the prescriber consents. It likewise bars pharmaceutical manufacturers and marketers from using such information for marketing absent consent. The prohibitions are subject to enumerated exceptions that permit dissemination and use for health-care research, enforcement of insurance formularies, patient care-management communications, law enforcement, and purposes otherwise provided by law. Pharmaceutical manufacturers promote brand-name drugs through a process called detailing, in which sales representatives visit physicians' offices to present information and samples. Pharmacies receive prescriber-identifying information when filling prescriptions pursuant to federal and state requirements and routinely sell that information to data-mining firms. The data miners analyze the records, produce reports on individual physicians' prescribing patterns, and lease the reports to pharmaceutical manufacturers under nondisclosure agreements so that detailers can tailor their presentations. Respondents are three Vermont data-mining companies and the Pharmaceutical Research and Manufacturers of America, an association of brand-name drug manufacturers. They filed two consolidated actions in the United States District Court for the District of Vermont. The suits named the Vermont Attorney General and other state officials as defendants. Respondents sought declaratory and injunctive relief on the ground that §4631(d) violates their First Amendment rights. After a bench trial the district court denied relief. The Court of Appeals for the Second Circuit reversed, holding that the statute unconstitutionally burdens protected speech. The Supreme Court granted certiorari to resolve the conflict with decisions of the First Circuit upholding similar statutes in Maine and New Hampshire. The Vermont Legislature accompanied the statute with formal findings. Detailing often conflicts with state public-health goals. Use of prescriber-identifying data increases the effectiveness of brand-name marketing. The resulting increase in prescriptions of newer, more expensive drugs raises healthcare costs. The Act also funded an evidence-based prescription-drug education program intended to promote therapeutic and cost-effective prescribing.
View caseEvergreen Bank challenged a state rule that prohibited pharmacists from advertising prices of ethical drugs. Consumer groups argued the ban suppressed information needed for informed purchasing. The Supreme Court evaluated whether the prohibition violated commercial speech protections.
Virginia law made it unprofessional conduct for a licensed pharmacist to publish, advertise, or promote any price for prescription drugs under Va. Code Ann. § 54-524.35(3). The Virginia State Board of Pharmacy regulated the profession to protect public health, safety, and welfare. It licensed pharmacists only after they showed good moral character, graduated from an approved school, completed up to twelve months of experience, and passed a Board examination. Licensed pharmacists remained subject to penalties or license revocation for negligence, fraud, or unprofessional conduct. Prescription drug prices varied sharply even within the same locality. In Richmond the cost of forty Achromycin tablets ranged from $2.59 to $6.00. In the Newport News-Hampton area the price of tetracycline ranged from $1.20 to $9.00. About ninety-five percent of prescriptions were filled with dosage forms prepared by manufacturers. Some pharmacies refused to quote prices over the telephone. An individual Virginia resident who suffered from diseases requiring daily prescription drugs, together with two nonprofit organizations whose members included many users of such drugs, brought suit against the Board and its members. The plaintiffs claimed the ban prevented them from learning where their limited resources could be spent most effectively. A prior challenge to the same statute brought by a drug retailer and one of its pharmacists had been rejected on due-process and equal-protection grounds. The three-judge District Court for the Eastern District of Virginia declared the quoted portion of the statute void and enjoined its enforcement. The Supreme Court noted probable jurisdiction of the Board's appeal.
View caseElliot Edmonds received an implanted medical device classified similarly to certain ethical drug regulations. After injury, he sued the manufacturer under state tort law. The Supreme Court addressed whether federal premarket approval requirements preempted the state claims.
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.
View caseEugene Ellsworth and other patients filed a class action against multiple manufacturers of ethical drugs alleging widespread harm. The Fifth Circuit examined whether common issues predominated over individual questions of reliance and causation for certification purposes.
In 1994, a group of plaintiffs consisting of cigarette smokers and their estates, including named representatives Ernest R. Perry, Sr., T. George Solomon, Jr., Dianne A. Castaño, Gloria Scott, and Deania Jackson, filed a class action complaint in the United States District Court for the Eastern District of Louisiana against the major American tobacco companies, specifically The American Tobacco Company, Inc., R.J. Reynolds Tobacco Company, Brown & Williamson Tobacco Corporation, Phillip Morris, Inc., Liggett & Meyers, Inc., Lorillard Tobacco Company, Inc., and United States Tobacco Company, as well as the Tobacco Institute, Inc. The complaint asserted nine causes of action arising from the defendants' alleged failure to inform consumers that nicotine is addictive and their manipulation of nicotine levels in cigarettes, seeking compensatory damages, punitive damages, attorneys' fees, and equitable remedies including a medical monitoring fund. The plaintiffs defined the proposed class to encompass all nicotine-dependent persons in the United States who purchased and smoked the defendants' cigarettes since 1943, along with their estates, representatives, administrators, spouses, children, relatives, and significant others as heirs or survivors. They limited the claims to conduct occurring since 1943 and conceded that each class member would need to prove addiction individually. In response to the district court's inquiry, the plaintiffs submitted a four-phase trial plan under which a jury would first resolve common issues of core liability such as the defendants' knowledge of nicotine's addictiveness, manipulation of nicotine levels, fraud, negligence, and conspiracy, followed by determination of compensatory damages in sample cases, processing of individual claims through forms and sampling, and application of a punitive damages ratio. After extensive briefing and a hearing on class certification, the district court issued a comprehensive opinion granting certification in part. The court certified the class under Federal Rule of Civil Procedure 23(b)(3) for core liability and punitive damages issues while denying certification under Rule 23(b)(2) for the equitable relief claims. The defendants then petitioned the district court for permission to pursue an interlocutory appeal pursuant to 28 U.S.C. § 1292(b), which the district court granted, after which the United States Court of Appeals for the Fifth Circuit accepted the appeal for review.
View caseAn ethical drug requires a physician's prescription for dispensing, whereas a proprietary drug may be sold directly to consumers without such oversight.
The doctrine provides that a manufacturer fulfills its duty to warn by adequately informing the prescribing physician of risks. The physician's independent judgment then breaks the causal chain to the patient unless the warnings were inadequate.
Supporting sources
…the First Amendment of a Virginia statute declaring that a pharmacist was guilty of "unprofessional conduct" if he advertised prescription drug prices. The pharmacist would then be subject to a monetary penalty or the suspension or revocation of his license. The statute thus effectively prevented the advertising of prescription…