Sample answer to Exam Question #4

Bell will most probably bring several claims based in products liability against Biohip. While negligence actions may also be available in some jurisdictions, most prefer a PL approach to injuries caused by unreasonably dangerous products.

In order to make out a PL cause of action under any particular theory of defect, plaintiff must allege and prove that i) defendant was a seller (not difficult here); ii) that he is a proper plaintiff (also not difficult here after McPherson, and most likely he or his insurance company purchased the hip directly); the product was defective (under one or more of three theories - design, manufacturing or warning); the defect existed at the time that the product left Biohipís possession (an issue most likely in the mfring c/a); cause-in-fact and proximate cause; and damages.

Manufacturing Defect

In order to make out a claim of manufacturing defect the plaintiff must allege and prove that the product was unreasonably dangerous by virtue of a manufacturing defect - that is that it was delivered to the plaintiff in a manner that did not conform to the productís design. This PL c/a looks most similar to strict liability, whereas the other two theories are more of a negligence hybrid. In this sense, if the hip was manufactured defectively, it does not matter how careful Biohip was in testing or assuring safe production. Strict liability cares not for fault.

While the ASTM tests did not reveal any manufacturing flaw in the product, plaintiff will have to allege, through the use of circumstantial evidence, that it is fair to infer that the Drís visual inspection would have revealed a defect. This can be done in several ways, including the use of experts who might explain that the type of fracture evidenced in the hip (once removed from Bell) indicated a kind of defect that could have been revealed visually prior to implantation. Here, Bellís argument will look like that in Negri and the American Museum of Natural History cases, where plaintiff need not rule out every other possible cause of the break, but merely creates the inference that it more likely than not that this type of mfring defect caused the break. (POE)

In this sense, the c/a looks somewhat like a res ipsa claim, although res ipsa is typically used as an evidentiary short cut in negligence, not SL, actions.

Might Biohip argue that their liability is cut off by virtue of the Drís negligent failure to do the visual inspection? Under a SL theory, the negligence of others is not relevant - and, as the commentators and jurists we read indicate: SL is applied in manufacturing defect cases because of the policy decision to include this type of liability into the cost of doing business. Indeed, one might want to ask whether Biohip can delegate this important quality control function to a third party.

Lastly, Biohip may argue that Bell bore some responsibility for his injury - his weight and rigorous physical activity - but the plaintiffís failure to exercise due care, if true, is not relevant in a SL c/a.

Finally, regarding mfring defect, Bell might take a McPherson approach and argue that under negligence principles, not PL, Biohip had a duty to adequately test the product prior to selling it to Bell, and it failed to do so here, in so far as the testing did not detect a mfring defect. Biohip will respond that they applied the most stringent testing, approved by the ASTM, the industry standard, and that evidenced their exercising due care in quality control. Bell will respond that compliance with industry custom is, typically, evidence of the exercise of due care, but nothing more - that is, the jury must consider compliance with custom as among the factors to weigh in making this conclusion, as was argued in Trimarco and T.J. Hooper.

In any case, plaintiff will have to show by a POE that the manufacturing defect caused the hip to fail - difficult here since at best heís got circumstantial evidence there of, and without more info from experts, the causation element will be difficult to carry.

Design Defect

Bell may also argue that the hip he received from Biohip was unreasonably dangerous by virtue of a design defect. Here, plaintiff must show all the same elements enumerated above, and will look to the nature of the hipís design to show the productís defectiveness.

How Bell will make out this c/a depends upon which jurisdiction he is in. Some jurisdictions, such as that in Soule, may allow Bell to use a consumer expectation approach to proving defective design - surely this will be Bellís preferred approach. Under this theory, Bell must show that the product failed to perform as safely as an ordinary consumer (objective) would expect. Here, Bell might reasonably have assumed that having undergone more than the recommended physical therapy, and having engaged in not terribly taxing activity (carrying paint cans isnít too strenuous), that the hip, some eight months later, would not fail in this manner.

However, where the question of design defect is one which is too technical for an ordinary consumer to form an opinion without the aid of experts, some jurisdictions, such as that in Camacho, take the view that a risk/utility analysis is more appropriate with respect to determining a defect in design. Similarly, in Potter the Connecticut Supreme Court urged a modified consumer expectation test when the evidence as to defect is quite technical or complex.

Under a risk/utility analysis - surely Biohipís preferred approach - the question will be whether the risks posed by the hipís design are reasonable in light of the utility of the hip. Camacho laid out a number of factors to be considered in making the risk/utility analysis, including the productís usefulness, its safety, availability of substitute products or designs/materials, feasibility of making the product safer without raising its cost too much or significantly diminishing its utility, obviousness of the risk to the consumer and/or ability to minimize risk with warnings, and finally the availability of spreading the costs of a more pricey design among consumers or through insurance.

In addition, in some jurisdictions, and under the 3d Restatement, plaintiff will be required to produce or persuade the fact finder that there is a reasonable alternative design - and that this design must bear a favorable safety/cost/utility ratio.

On these facts, it is difficult to say whether Bell will be able to prove design defect under a risk/utility analysis. Surely he will want to look to other hips manufactured by Biohipís competitors to see if they are stronger and price competitive.

Biohip will, no doubt, point to the fact that the FDA has already engaged in some sort of risk/utility calculus prior to granting the license for the hip - as they investigated safety and efficacy prior to approving the device. Query whether that calculus is the same as that demanded by PL law. Here Bell would argue that the FDA calculus establishes a floor of safety, whereas Biohip will argue it establishes is ceiling.

Part of Bellís argument will be that it is foreseeable that people of Bellís weight will need hip replacements, and will have the Biohip product implanted. In this sense, Biohip should incorporate the stress of a 270 pound person doing activities like carrying paint into their design of the hip.

Warning Defect

Finally, Bell will argue that the hip was rendered unreasonably dangerous by virtue of an inadequate warning from the manufacturer regarding the risks of the use of this hip. Under this theory of recovery, a product that has significant social utility, and which carries with it certain risks, can minimize, if not eliminate, those unreasonable risks by providing either instructions on use or warnings to the consumer. In this sense, the mfr transfers to the consumer the risk/utility information and s/he then decides for him or herself whether to use the product.

The default rule that the mfr must communicate these warnings to the consumer is excepted where the product is delivered to the consumer through a learned intermediary (LI)- such as a doctor prescribing medication, or here, implanting a prosthetic device. As this exception is articulated by the court in Edwards, where the learned intermediary is given complete warnings about the risks inherent in the use of the product, the intermediary can than filter, adjust, and translate those warnings to the patient in light of the particularities of the patientsí needs/vulnerabilities/conditions. The learned intermediary bar to mfr liability for warning the consumer of risks is not engaged, however, where the warnings provided to the LI are inadequate. Pittman provides a number of factors to consider when assessing the adequacy of the warnings, and Hood considers the specificity of the warnings in relation to risk.

Here, the warnings provided to Dr. Bonze indicated that for a short time after the operation, the patient should watch his or her weight and refrain from strenuous activity. These warnings did not indicate clearly a risk, about which all experts seem to agree, of fracture of the hip for heavy people. Had Bonze known this, and communicated it to Bell, he may have pursued a different course of treatment: lose weight before the operation, choose a different therapy, choose a different hip. Itís also not clear from the warnings Bonze received that strenuous activity (assuming thatís what Bell was engaging in) almost a year later might stress the hip to the point of fracture.

Finally, with respect to the FDA licensing, the govít requires that Biohip label the product for intended use. If it had been Biohipís intention that the product be used only for thin to moderately heavy people, then the product should have been so labeled - thereby accomplishing the same thing as a warning.



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