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Brown v. Superior Court, 751 P.2d 470 |
California Supreme Court |
1988 |
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Chapter |
16 |
Title |
Products Liability |
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Page |
669 |
Topic |
The Definition Of Defective |
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Quick Notes |
A drug manufacture cannot be held strictly liable for defective design or failure to warn. |
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Book Name |
Torts Cases, Problems, And Exercises. Weaver, Third Edition. ISBN: 978-1-4224-7220-0. |
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Issue |
o Whether a prescription drug manufacturer may be held strictly liable for a product that is defective in design? No. |
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Procedure |
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Trial |
o The defendants could not be held strictly liable. |
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Appellant |
o Affirmed |
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Supreme |
o Affirmed |
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Facts |
Reason |
Rules |
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o Pl - Brown o Df - Superior Court What happened? o A number of plaintiffs filed actions in the San Francisco Superior Court against numerous drug manufacturers which allegedly produced DES, a substance plaintiffs claimed was used by their mothers to prevent miscarriage. o They alleged that the drug was defective and they were injured in utero when their mothers ingested it. Trial Court o It determined that defendants could not be held strictly liable for the alleged defect in DES but only for their failure to warn of known or knowable side effects of the drug. o It held further that neither breach of warranty nor fraud will lie in an action based on the market share theory of Sindell. Court Of Appeals o Affirmed Supreme Court o |
Comment k o Imposes liability on a drug manufacturer ONLY IF it failed to warn of a defect of which it either knew or should have known. o This does not focus on the deficiency of the product. o It focuses on the fault of the producer failing to warn against inherent dangers. o This idea rings of negligence.
Three Distinct Choices 1. To hold that the manufacturer of a prescription drug is strictly liable for a defect in its product because it was defectively designed, as that term is defined in Barker, OR because of a failure to warn of its dangerous propensities even though such dangers were neither known nor scientifically knowable at the time of distribution; 2. To determine that liability attaches only if a manufacturer fails to warn of dangerous propensities of which it was or should have been aware, in conformity with comment k; OR 3. To decide that strict liability for design defects should apply to prescription drugs unless the particular drug which caused the injury is found to be "unavoidably dangerous.
Design Defect Test (Consumer Expectation Test) 1. Whether the product performed as safely as the ordinary consumer would expect when used as intended and in a reasonably foreseeable manner,
(Risk Utility Test) 2. Whether, on balance, the benefits of the challenged design outweighed the risk of danger inherent in the design.
Df Arg Neither Test is applicable 1. The court agrees that the warning is meant for the physician that relates the information to his patient about the drugs propensities. a. The manufacturer CANNOT be held liable for the doctors failure to relate the warning to the patient.
2. The Df says that prescription drugs cannot be redesigned because of the scientific constant required of the formula. a. Court disagrees because you can remove a component of the drug that makes it unsafe without affecting the efficacy [effectiveness] of the drug. b. The Pl could prove there were other less harmful drugs that prevent miscarriage. The benefit of such alternative drugs could be weighed against the advantages of DES in making the risk/benefit analysis of Barker.
Reason o Just because a drug has dangerous defects, does not necessarily make it strictly liable. o The determination is if the public interest would be served by the imposition of such liability.
Purpose Of Strict Liability o The fundamental reasons underlying the imposition of strict liability are to o (1) deter manufacturers from marketing products that are unsafe, and o (2) to spread the cost of injury from the plaintiff to the consuming public, which will pay a higher price for the product to reflect the increased expense of insurance to the manufacturer resulting from its greater exposure to liability.
Distinctions between Prescription Drugs and other products o Products like machinery or perfume make life easier and more enjoyable. o Products like prescription drugs may be necessary to alleviate pain or sustain life and their side affects to some users might be unavoidable.
Public Policy o PP favors the development and marketing of beneficial new drugs, even though some risks might accompany their introduction. o If drug manufacturers were subject to strict liability, they might be reluctant to undertake research programs to develop beneficial drugs out of fear of large adverse monetary judgments.
Example Rising Costs Prohibiting New Drugs from reaching the public o Insurance almost equaling the entire income of the sale. o Mass inoculation would subject it to enormous liability. o Could not obtain adequate liability insurance.
Holding Defective Design o We decline to hold that a drug manufacturers liability for injuries cause by the defective design of prescript drugs should be measure by the standard set forth in Barker.
Holding Failure to Warn (Negligence) o Reject that a drug manufacturer should be held strictly liability for failure to warn of risks inherent in a drug.
Affirmed |
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Class Notes |
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Comment k o Imposes liability on a drug manufacturer ONLY IF it failed to warn of a defect of which it either knew or should have known. o This does not focus on the deficiency of the product. o It focuses on the fault of the producer failing to warn against inherent dangers. o This idea rings of negligence.
Learned Intermediary Doctrine o The manufacturer duty is to provide warnings and instructions to the physician who will prescribe the drug. o The physician in turn is responsible for informing the patient of relevant risks so that the patient can give an informed consent to the treatment.
Properly Prepared and Accompanied by warnings (No Strict Liability) o A manufacturer is not strictly liable for injuries caused by a prescription drug so long as the drug was properly prepared and accompanied by warnings of its dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution.
Duty To Warn (Defective if absent to warn) o A product may be defective because of the absence of a warning that was necessary to allow its safe use
Duty To Warn (Seller has knowledge OR should have knowledge because of skillset) o The duty to warn is confined to a situation in which the seller has knowledge or by the application of reasonable, developed human skill and foresight should have knowledge of the danger.
Consumer contemplation test does not work very well, b/c we dont know who the end user is.
Public Policy o PP favors the development and marketing of beneficial new drugs, even though some risks might accompany their introduction. o If drug manufacturers were subject to strict liability, they might be reluctant to undertake research programs to develop beneficial drugs out of fear of large adverse monetary judgments.
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Rules |
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Difference between Strict Liability (Product) and Negligence (Conduct) o Strict liability differs from negligence in that it eliminates the necessity for the injured party to prove that the manufacturer of the product which caused injury was negligent. It focuses not on the conduct of the manufacturer but on the product itself, and holds the manufacturer liable if the product was defective.
Properly Prepared and Accompanied by warnings (No Strict Liability) o A manufacturer is not strictly liable for injuries caused by a prescription drug so long as the drug was properly prepared and accompanied by warnings of its dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution.
No Strict Liability for Drug Manufacturers (Defectively Designed Drugs) (1) A drug manufacturer's liability for a defectively designed drug should not be measured by the standards of strict liability; (2) because of the public interest in the development, availability, and reasonable price of drugs, the appropriate test for determining responsibility is the test stated in comment k of Restatement (Second) of Torts 402A; and (3) for these same reasons of policy, the court disapproves the holding that only those prescription drugs found to be "unavoidably dangerous" should be measured by the comment k standard and that strict liability should apply to drugs that do not meet that description.
Duty To Warn (Manufacture not liable, if it has provided appropriate warnings) o The manufacturer cannot be held liable if it has provided appropriate warnings and the doctor fails in his duty to transmit these warnings to the patient or if the patient relies on inaccurate information from others regarding side effects of the drug. It is well established that a manufacturer fulfills its duty to warn if it provides adequate warning to the physician.
Duty To Warn (Defective if absent to warn) o A product may be defective because of the absence of a warning that was necessary to allow its safe use
Duty To Warn (Seller has knowledge OR should have knowledge because of skillset) o The duty to warn is confined to a situation in which the seller has knowledge or by the application of reasonable, developed human skill and foresight should have knowledge of the danger.
Cmt k: unavoidably unsafe products o A lot of times drugs are unreasonably unsafe. It is a choice of either having this dangerous product or nothing at all. Often it is necessary to have the product despite the danger. If this is the case then THERE IS NO STRICT LIABILITY.
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