1201. Strict Liability—Manufacturing Defect—Essential Factual Elements
[Name of plaintiff] claims that the [product] contained a manufacturing defect. To establish this claim, [name of plaintiff] must prove all of the following:
1. That [name of defendant] [manufactured/distributed/sold] the [product];
2. That the [product] contained a manufacturing defect when it left [name of defendant]’s possession;
3. That [name of plaintiff] was harmed; and
4. That the [product]’s defect was a substantial factor in causing [name of plaintiff]’s harm.
New September 2003; Revised April 2009, December 2009, June 2011
Directions for Use
To make a prima facie case, the plaintiff has the initial burden of producing evidence that he or she was injured while the product was being used in an intended or reasonably foreseeable manner. If this prima facie burden is met, the burden of proof shifts to the defendant to prove that the plaintiff’s injury resulted from a misuse of the product. . . . Product misuse is a complete defense to strict products liability if the defendant proves that an unforeseeable abuse or alteration of the product after it left the manufacturer’s hands was the sole cause of the plaintiff’s injury. . . Misuse or modification that was a substantial factor in, but not the sole cause of, plaintiff’s harm may also be considered in determining the comparative fault of the plaintiff or of third persons. . . .
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1202. Strict Liability—“Manufacturing Defect” Explained
A product contains a manufacturing defect if the product differs from the manufacturer’s design or specifications or from other typical units of the same product line.
New September 2003
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1203. Strict Liability—Design Defect—Consumer Expectation Test—Essential Factual Elements
[Name of plaintiff] claims the [product]’s design was defective because the [product] did not perform as safely as an ordinary consumer would have expected it to perform. To establish this claim, [name of plaintiff] must prove all of the following:
1. That [name of defendant] [manufactured/distributed/sold] the [product];
2. That the [product] did not perform as safely as an ordinary consumer would have expected it to perform when used or misused in an intended or reasonably foreseeable way;
3. That [name of plaintiff] was harmed; and
4. That the [product]’s failure to perform safely was a substantial factor in causing [name of plaintiff]’s harm.
New September 2003; Revised December 2005, April 2009, December 2009, June
2011
Directions for Use
If both tests (the consumer expectation test and the risk-benefit test) for design defect are asserted by the plaintiff, the burden-of-proof instructions must make it clear that the two tests are alternatives. . . . The court must make an initial determination as to whether the consumer expectation test applies to the product. In some cases, the court may determine that the product is one to which the test may, but not necessarily does, apply, leaving the determination to the jury . . . . In such a case, modify the instruction to advise the jury that it must first determine whether the product is one about which an ordinary consumer can form reasonable minimum safety expectations.
To make a prima facie case, the plaintiff has the initial burden of producing evidence that he or she was injured while the product was being used in an intended or reasonably foreseeable manner. If this prima facie burden is met, the burden of proof shifts to the defendant to prove that the plaintiff’s injury resulted from a misuse of the product. . . . Product misuse is a complete defense to strict products liability if the defendant proves that an unforeseeable abuse or alteration of the product after it left the manufacturer’s hands was the sole cause of the plaintiff’s injury. . . . Misuse or modification that was a substantial factor in, but not the sole cause of, plaintiff’s harm may also be considered in determining the comparative fault of the plaintiff or of third persons. . . .
1204. Strict Liability—Design Defect—Risk-Benefit Test—Essential Factual Elements—Shifting Burden of Proof
[Name of plaintiff] claims that the [product]’s design caused harm to [name of plaintiff]. To establish this claim, [name of plaintiff] must prove all of the following:
1. That [name of defendant] [manufactured/distributed/sold] the [product];
2. That [name of plaintiff] was harmed; and
3. That the [product]’s design was a substantial factor in causing harm to [name of plaintiff].
If [name of plaintiff] has proved these three facts, then your decision on this claim must be for [name of plaintiff] unless [name of defendant] proves that the benefits of the [product]’s design outweigh the risks of the design. In deciding whether the benefits outweigh the risks, you should consider the following:
(a) The gravity of the potential harm resulting from the use of the [product];
(b) The likelihood that this harm would occur;
(c) The feasibility of an alternative safer design at the time of manufacture;
(d) The cost of an alternative design; [and]
(e) The disadvantages of an alternative design; [and]
[(f) [Other relevant factor(s)].]
New September 2003; Revised February 2007, April 2009, December 2009, December 2010, June 2011
Directions for Use
If the plaintiff asserts both tests for design defect (the consumer expectation test and the risk-benefit test), the instructions must make it clear that the two tests are alternatives. . . . Risk-benefit weighing is not a formal part of, nor may it serve as a defense to, the consumer expectations test. . . .
To make a prima facie case, the plaintiff has the initial burden of producing evidence that he or she was injured while the product was being used in an intended or reasonably foreseeable manner. If this prima facie burden is met, the burden of proof shifts to the defendant to prove that the plaintiff’s injury resulted from a misuse of the product. . . . Product misuse is a complete defense to strict products liability if the defendant proves that an unforeseeable abuse or alteration of the product after it left the manufacturer’s hands was the sole cause of the plaintiff’s injury. . . . Misuse or modification that was a substantial factor in, but not the sole cause of, plaintiff’s harm may also be considered in determining the comparative fault of the plaintiff or of third persons. . . .
Aesthetics might be an additional factor to be considered in an appropriate case in which there is evidence that appearance is important in the marketability of the product. . . . .
1205. Strict Liability—Failure to Warn—Essential Factual Elements
[Name of plaintiff] claims that the [product] lacked sufficient [instructions] [or] [warning of potential [risks/side effects/allergic reactions]]. To establish this claim, [name of plaintiff] must prove all of the following:
1. That [name of defendant] [manufactured/distributed/sold] the [product];
2. That the [product] had potential [risks/side effects/allergic reactions] that were [known/ [or] knowable in light of the [scientific/ [and] medical] knowledge that was generally accepted in the scientific community] at the time of [manufacture/distribution/sale];
3. That the potential [risks/side effects/allergic reactions] presented a substantial danger when the [product] is used or misused in an intended or reasonably foreseeable way;
4. That ordinary consumers would not have recognized the potential [risks/side effects/allergic reactions];
5. That [name of defendant] failed to adequately warn [or instruct] of the potential [risks/side effects/allergic reactions];
6. That [name of plaintiff] was harmed; and
7. That the lack of sufficient [instructions] [or] [warnings] was a substantial factor in causing [name of plaintiff]’s harm.
[The warning must be given to the prescribing physician and must include the potential risks, side effects, or allergic reactions that may follow the foreseeable use of the product. [Name of defendant] had a continuing duty to warn physicians as long as the product was in use.]
New September 2003; Revised April 2009, December 2009, June 2011, December
2011
Directions for Use
With regard to element 2, it has been often stated in the case law that a manufacturer is liable for failure to warn of a risk that is “knowable in light of generally recognized and prevailing best scientific and medical knowledge available” . . . . The advisory committee believes that this standard is captured by the phrase “generally accepted in the scientific community.” A risk may be “generally recognized” as a view (knowledge) advanced by one body of scientific thought and experiment, but it may not be the “prevailing” or “best” scientific view; that is, it may be a minority view. The committee believes that when a risk is (1) generally recognized (2) as prevailing in the relevant scientific community, and (3) represents the best scholarship available, it is sufficient to say that the risk is knowable in light of “the generally accepted” scientific knowledge.
The last bracketed paragraph should be read only in prescription product cases: “In the case of prescription drugs and implants, the physician stands in the shoes of the ‘ordinary user’ because it is through the physician that a patient learns of the properties and proper use of the drug or implant. Thus, the duty to warn in these cases runs to the physician, not the patient.” . . . .
To make a prima facie case, the plaintiff has the initial burden of producing evidence that he or she was injured while the product was being used in an intended or reasonably foreseeable manner. If this prima facie burden is met, the burden of proof shifts to the defendant to prove that the plaintiff’s injury resulted from a misuse of the product. . . . Product misuse is a complete defense to strict products liability if the defendant proves that an unforeseeable abuse or alteration of the product after it left the manufacturer’s hands was the sole cause of the plaintiff’s injury. . . . Misuse or modification that was a substantial factor in, but not the sole cause of, plaintiff’s harm may also be considered in determining the comparative fault of the plaintiff or of third persons. . . .