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Learned intermediary is a defense doctrine used in the legal system of the United States. This doctrine states that a manufacturer of a product has fulfilled its duty of care when it provides all of the necessary information to a "learned intermediary" who then interacts with the consumer of a product. This doctrine is primarily used by pharmaceutical and medical device manufacturers in defense of tort suits.
In a clear majority of states, the courts have accepted this as a liability shield for pharmaceutical companies.
This doctrine was adopted by the Supreme Court of Canada in Hollis v Dow Corning Corp., 129 DLR 609 (1995).
The use of the term "learned intermediary" was first used in the Eighth Circuit decision of Sterling Drug v. Cornish (370 F.2d 82, 85), in 1966, and has now become the prevailing doctrine in the majority of jurisdictions in the United States.
Recently, this doctrine has been called into question due to the increased use of direct to consumer advertising, whereby drug manufacturers market pharmaceutical products to individuals rather than to doctors. For example, in Rimbert v. Eli Lilly & Co. , 577 F. Supp. 2d 1174, 1218-19 (D. N.M. 2008), the District Court of New Mexico reasoned that the "dramatically increased marketing directed to consumers . . . would persuade the Supreme Court of New Mexico that the justification for the learned-intermediary doctrine is quickly becoming, if not already the case, outdated." However, other recent cases have declined to adopt this so-called "direct-to-consumer advertising" exception to the learned intermediary doctrine. See DiBartolo v. Abbott Labs., 2012 WL 6681704 (S.D.N.Y. Dec.21, 2012), Centocor Inc. v. Hamilton, 372 S.W.3d 140, 161 (Tex. 2012), Calisi v. Abbott Labs., 2013 WL 5462274 (D. Mass. Feb. 25, 2013).
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The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Product liability is the area of law in which manufacturers, distributors, suppliers, retailers, and others who make products available to the public are held responsible for the injuries those products cause. Although the word "product" has broad connotations, product liability as an area of law is traditionally limited to products in the form of tangible personal property.
Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company is ranked No. 36 on the 2021 Fortune 500 list of the largest United States corporations by total revenue. Johnson & Johnson is one of the world's most valuable companies, and is one of only two U.S.-based companies that has a prime credit rating of AAA, higher than that of the United States government.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013. The CEO of Abbott said in 2015 that the company had been in India for over a century; it was named Abbott India Ltd. in 2002.
Many countries have measures in place to limit advertising by pharmaceutical companies.
In patent law, the research exemption or safe harbor exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. According to this exemption, despite the patent rights, performing research and tests for preparing regulatory approval, for instance by the FDA in the United States, does not constitute infringement for a limited term before the end of patent term. This exemption allows generic manufacturers to prepare generic drugs in advance of the patent expiration.
Virginia State Pharmacy Board v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976), was a case in which the United States Supreme Court held that a state could not limit pharmacists’ right to provide information about prescription drug prices. This was an important case in determining the application of the First Amendment to commercial speech.
Lexmark International, Inc. v. Static Control Components, Inc., is an American legal case involving the computer printer company Lexmark, which had designed an authentication system using a microcontroller so that only authorized toner cartridges could be used. The resulting litigation has resulted in significant decisions affecting United States intellectual property and trademark law.
Direct-to-consumer advertising (DTCA) refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. The term is synonymous primarily with the advertising of prescription medicines via mass media platforms—most commonly on television and in magazines, but also via online platforms.
ConsumerLab.com, LLC. is a privately held American company registered in White Plains, NY. It is a publisher of test results on health, wellness, and nutrition products. Consumer Labs is not a laboratory, but contracts studies to outside laboratories. It purchases supplement products and other consumer goods directly from public storefronts and publishes reports based on the results. It primarily derives revenue from the sale of subscriptions to its online publications. Other sources of revenue include a proprietary certification program, licensing fees, contents re-publication license fees and advertising.
Sindell v. Abbott Laboratories, 26 Cal. 3d 588 (1980), was a landmark products liability decision of the Supreme Court of California which pioneered the doctrine of market share liability.
FDA preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding products approved by the Food and Drug Administration (FDA). It has been a highly-contentious issue. In general, consumer groups are against it, but the FDA and pharmaceutical manufacturers are in favor of it and argues that the FDA should set both the floor and the ceiling for drug regulation.
Illinois Brick Co. v. Illinois, 431 U.S. 720 (1977), is a United States Supreme Court case that involved issues concerning statutory standing in antitrust law.
Market share liability is a legal doctrine that allows a plaintiff to establish a prima facie case against a group of product manufacturers for an injury caused by a product, even when the plaintiff does not know from which defendant the product originated. The doctrine is unique to the law of the United States and apportions liability among the manufacturers according to their share of the market for the product giving rise to the plaintiff's injury.
Inwood Laboratories Inc. v. Ives Laboratories, Inc., 456 U.S. 844 (1982), is a United States Supreme Court case, in which the Court confirmed the application of and set out a test for contributory trademark liability under § 32 of the Lanham Act.
Ciba-Geigy Canada Ltd. v. Apotex Inc., [1992] 3 SCR 120, is a Supreme Court of Canada judgment on trademark law and more specifically the issue of passing off. Ciba-Geigy brought an action against Apotex and Novopharm, alleging that their versions of the prescription drug metoprolol were causing confusion to the public due to their similar appearance to Ciba-Geigy's version of the drug Lopresor. On appeal to the SCC, the issue was whether a plaintiff is required to establish that the public affected by the risk of confusion includes not only health care professionals but also the patients who consume the drugs in a passing off action involving prescription drugs of a similar appearance. The Supreme Court held affirmatively on this question.
Rosetta Stone v. Google, 676 F.3d 144 was a decision of the United States Court of Appeals for the Fourth Circuit that challenged the legality of Google's AdWords program. The Court overturned a grant of summary judgment for Google that had held Google AdWords was not a violation of trademark law.
United States v. Parke, Davis & Co., 362 U.S. 29 (1960), was a 1960 decision of the United States Supreme Court limiting the so-called Colgate doctrine, which substantially insulates unilateral refusals to deal with price-cutters from the antitrust laws. The Parke, Davis & Co. case held that, when a company goes beyond "the limited dispensation" of Colgate by taking affirmative steps to induce adherence to its suggested prices, it puts together a combination among competitors to fix prices in violation of § 1 of the Sherman Act. In addition, the Court held that when a company abandons an illegal practice because it knows the US Government is investigating it and contemplating suit, it is an abuse of discretion for the trial court to hold the case that follows moot and dismiss it without granting relief sought against the illegal practice.
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.