Also known as:information defects · informational defect · informational defects · warning defect · failure to warn
Written by attorneys · grounded in primary & secondary sources — see below
A type of product defect that exists when a commercial supplier provides inadequate warnings or instructions about dangers that may not be apparent to users. The defect renders the product unreasonably dangerous because users lack notice of hidden risks that proper labeling would reveal.
Sources & Authorities
How it applies
Common Examples
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Physician Receives Full Risk Disclosure
Innovate Pharmaceuticals supplied its new medication to Dr. Isaacs with a detailed package insert listing all known side effects including rare cardiac risks. Dr. Isaacs reviewed the insert and prescribed the drug to patient Ivan Ivanov. Ivanov later suffered a heart arrhythmia and sued the manufacturer for failure to warn. Because the manufacturer had adequately informed the prescribing physician, the learned intermediary doctrine prevented liability for any information defect.
Manufacturer Warns Medical Community
Indigo Textiles distributed a prescription pain reliever accompanied by comprehensive risk information sent directly to physicians and pharmacists. Patient Isla Ireland received the drug from her doctor and later developed an undisclosed allergic reaction. Ireland sued the manufacturer claiming an information defect. The court held that the manufacturer satisfied its duty by warning the learned intermediary and therefore escaped liability for failure to warn the patient directly.
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Cases
Course Outlines
Prescription Drug Lacks Physician Warning
Ironwood Capital manufactured a prescription antibiotic without including any warning about a known risk of tendon rupture in its materials sent to physicians. Patient Ike Ingram received the drug and suffered a ruptured tendon. Ingram sued alleging an information defect. The absence of an adequate warning to the prescribing physician allowed the claim to proceed because the learned intermediary never received the necessary risk information.
Brown v. Superior Court44 Cal.3d 1049, 751 P.2d 470, 245 Cal.Rptr. 412 (1988)
Medical Device Warning Preempted
Infinity Bank produced a pacemaker that carried FDA-approved labeling. Patient Ira Irving underwent implantation and later experienced device failure that the labeling had addressed. Irving sued claiming an information defect under state law. Federal preemption principles barred the claim because the manufacturer had complied with federal labeling requirements that conflicted with additional state warning duties.
Medtronic, Inc. v. Lohr518 U.S. 470, 485 (1996)
Asbestos Labels Omit Known Hazards
Isaac Irving worked with insulation products supplied by a manufacturer that provided no warning labels about the risk of asbestosis. After developing the disease, Irving sued alleging an information defect. The court permitted the claim because the absence of any warning about a latent danger known to the supplier constituted an information defect under strict products liability.
Beshada v. Johns-Mansville Products Corp.447 A.2d 539, 546-547 (N.J. 1982)
DES Market Share Liability
Several manufacturers produced the drug DES without adequate warnings about the risk of cancer in offspring. Plaintiff Ilana Isaacs developed cancer after in utero exposure and could not identify the specific manufacturer. She sued under market-share liability for an information defect. The court allowed recovery against manufacturers who had failed to provide sufficient warnings even though the precise supplier remained unknown.
Sindell v. Abbott Laboratories26 Cal. 3d 588 (1980)
Common questions
Frequently Asked
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What distinguishes an information defect from a design or manufacturing defect?+
An information defect arises solely from inadequate warnings or instructions about latent dangers. A manufacturing defect occurs when a product deviates from the intended design, and a design defect exists when the entire product line poses unreasonable risks that could have been reduced by a feasible alternative.
Supporting sources
Does the learned intermediary doctrine eliminate liability for an information defect in prescription drug cases?+
The doctrine relieves the manufacturer of a duty to warn the patient directly when the manufacturer has provided adequate warnings to the prescribing physician. Liability for an information defect still exists if the warnings given to the physician were inadequate or misleading.
Supporting sources
When does a product carry an information defect under strict liability?+
A product carries an information defect when it lacks warnings about dangers that are not obvious to users and that render the product unreasonably dangerous. The supplier must provide adequate notice so that users can make informed decisions about the risks.
Supporting sources
551 P.2d 334, 342 (Cal. 1976)Torts
…without leave to amend. The Supreme Court held that plaintiffs could state a cause of action against the psychotherapists for failure to warn the victim of a danger of violence posed by the patient, but could not state a cause of action for failure to confine the patient. Majority opinion Opinion of Tobriner, J. On…