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Medical devices are so closely associated with prescription drugs that they can be virtually indistinguishable to the consumer. A patient is given a pacemaker and heart medication. A diabetic is given a test kit to monitor blood sugar, along with prescribed insulin. But when it comes to product liability analysis, the distinction between medical devices and prescription drugs is crucial, given that prescription drugs are exempt from strict liability for design defect. The liability standard for medical device design defect depends, in part, on whether the device is implanted. Implanted medical devices are also exempt from strict liability for design defect. The standard of liability for design defects in non-implanted prescription medical devices, which make up a large sector of the industry, is far less clear. This article explores the genesis of the exemption from strict liability granted by case law to implanted medical devices and suggests arguments that a non-implanted prescription medical device defendant may make when faced with the question of what liability test should apply. The California Supreme Court, in Barker v. Lull Engineering Co., 20 Cal.3d 413 (1978), delineated two alternative tests to instruct a jury on design defect in a products liability action: the ordinary consumer expectation test and the risk-benefit test. The consumer expectation test permits a plaintiff to prove design defect by demonstrating that the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner. The ordinary consumer expectation test is reserved for cases in which the everyday experience of the product’s user permits a conclusion that the product’s design violated minimum safety standards. Under the risk-benefit test, the product is found to be defective, according to the Supreme Court, “if the jury finds that the risk of danger inherent in the challenged design outweighs the benefits of such design.” When the analysis calls for a “careful assessment of feasibility, practicality, risk and benefit” or where the plaintiff’s theory of defect seeks to examine the behavior of “obscure components under complex circumstances” outside the ordinary experience of the consumer, the risk-benefit test should be the only instruction given. In applying Barker, California courts have recognized that certain products are within the consuming public’s everyday experience — such as a grab bar in a passenger bus, insulation that contains asbestos and can cause a fatal disease, home pesticides that can cause injuries. There is a trend, however, acknowledging the complex nature of a product’s design and circumstances surrounding a product failure, which falls outside the consuming public’s general knowledge. Consistent with this approach, California courts have concluded that the deployment of an air bag “fortunately” is not part of the everyday experience of the consuming public. ( Pruitt v. General Motors Corp. 72 Cal. App.4th 1480 (1999)). Similarly, the risk-benefit test, rather than the consumer expectation test, has been deemed appropriate for cases involving a tractor, an emergency shut-off switch on a commercial cotton picker, a front-end loader and the frame and suspension of an automobile. The composition and allergenic proteins of natural rubber latex gloves have also been found to be “complex,” thereby precluding the use of the consumer expectation test in the context of the California coordinated proceedings pertaining to alleged allergic reactions by health care professionals having to use protective gloves pursuant to regulations from the Center for Disease Control. Citing cases involving latex gloves, California’s Third District Court of Appeal, in an unpublished opinion in Unde v. L’Oreal USA, 2004 WL 740034, upheld the preclusion of the consumer expectation test in a case involving over-the-counter face cream, finding the creation and exacerbation of allergies is beyond the purview of the consumer expectation test. Ten years after issuing the Barker decision, the California Supreme Court addressed the question of whether the strict liability tests defined therein should apply to prescription drug design defect. Drawing partly on comment K to section 402A of the Restatement of Torts (Second), and public policies, the court, in Brown v. Superior Court, 44 Cal.3d 1049 (1988), concluded that a prescription drug manufacturer’s liability for a defectively designed drug should not be measured by the standards of strict liability. The court also rejected the use of the Barker tests for prescription drugs. In its Brown ruling, the court deemed Barker‘s consumer expectation test unfeasible because the user is not the patient but rather the physician who prescribes the drug and is presumed to be fully aware of the inherent risks involved. “Reasons of policy” underscored in Brown formed the backbone of the liability exemption from the risk-benefit test of Barker. More protection for a manufacturer is justified when the product is created to alleviate pain and suffering or to sustain life rather than to make work easier or provide pleasure. While the court made reference to “other important medical products” such as wheelchairs, apparently to illustrate that harm to some users can be avoided for some medical products, it also stated that “harm to some users from prescription drugs is unavoidable,” noting that “the broad public interest in the availability of drugs at an affordable price must be considered in deciding the appropriate standard of liability for injuries resulting from their use.” The Brown court ultimately held that all prescription drugs are exempt from strict liability for design defect. In Hufft v. Horowitz, 4 Cal.App.4th 8 (1992), a case involving an implanted penile prosthesis, the Fourth District Court of Appeal specifically extended the Brown rule to implanted medical devices, holding that strict liability does not apply to manufacturers of implanted prescription medical devices that have been “properly made” and “distributed with information regarding risks and dangers” that were known or should have been known at the time of distribution. The court’s analysis is interesting, for while it took pains to emphasize and reaffirm the public policy considerations articulated in Brown — considerations that can arguably apply to non-implanted devices as well — it declined to engage in a qualitative analysis as to whether the implanted device at issue served these goals. The court acknowledged that the implant at issue in Hufft was not lifesaving, but nonetheless “restor[es] a degree of normalcy to the lives of those who suffer organic dysfunctions and an impaired quality of life.” In a footnote, the court declined to examine the reason a patient may have sought an implanted medical device, saying it “would be inappropriate for us to consider the patient’s subjective motivation for having an implant.” Yet the Hufft court also used unequivocal language to reaffirm the policy considerations behind Brown, saying “in a world of tradeoffs, society is well served by restricting available avenues of monetary recovery in exchange for increasing availability of life-saving, suffering-alleviating products. That policy applies to medical devices and prescription drugs alike.” Since Hufft, other decisions have extended the Brown immunity to breast implants, viscoelastic fluid used as intraocular surgical aids and intrauterine devices. No published opinions directly address the issue of non-implanted prescription medical devices. But a recent unpublished opinion from the Fourth District, Warner v. Breg, 2004 WL 68757, refused to extend the strict liability exemption to a prescription cold therapy device provided to a patient following knee surgery. The device at issue consisted of a cooler holding ice and water, an electric pump that circulated the cold water from the cooler to a pad wrapped around the injured body part and a thermometer that measured the temperature of the water as it passed from the pad to the cooler. The plaintiff suffered third-degree frostbite and was permanently disabled when the device failed to function properly. In its unpublished opinion, the Fourth District concluded that extensions of Brown are limited to “implanted medical devices that become parts of the person,” and not to an “externally applied mechanical device” such as the one at issue. Moreover, the court concluded that even though the device was prescribed by a doctor, it was operated outside the presence or direct supervision of medical personnel. The court, after concluding that the trial court mistakenly assumed the device was exempt from strict liability, reversed and vacated the grant of summary judgment and remanded the case to the lower court. The Warner case did not involve a lifesaving medical device. If it had, the outcome may have been different. Missing from the Warner court’s reasoning was any acknowledgement of the public policies behind Brown and its progeny. The vital nature of non-implanted prescription medical devices, such as devices used in oxygen therapy for patients suffering from lung cancer, dialysis equipment or devices used to treat diabetes, surely fall within the Hufft and Brown courts’ definitions of “life-saving, suffering-alleviating products.” Notwithstanding the unpublished Warner decision, a medical device defendant should be able to argue that the policies enunciated in Brown and its progeny support the extension of that case to non-implanted prescription medical devices — particularly if the device at issue is life-saving. If manufacturers are subject to strict liability, they may be reluctant to undertake research programs to develop new life-saving devices for fear of large adverse monetary judgments. As the Brown court reasoned, the determination of strict liability exposure depends on whether the public interest would be served. Extension of Brown to prescription medical devices would best serve the public, just as the public has been served through the protections afforded to pharmaceutical companies and implanted medical devices. If the medical device defendant loses its public policy argument and finds itself facing a strict liability analysis, it should be able to make a strong argument that Barker‘s risk-benefit test is the only appropriate jury instruction. This is a critical argument because if the consumer expectation test is given in cases involving medical devices and equipment, the manufacturer is precluded from submitting expert testimony regarding the product’s design and is thereby hindered in its ability to adequately defend itself at trial. Medical devices and equipment are complex products, requiring expert analysis of the entire design process from inception to production. The considerations involved in the design of a baby incubator or ultrasound machine (e.g. safety, expected use, portability, ease of use, cost, accessibility and/or reliability) are no less complex than those involved in the design of industrial equipment or operation of an air bag. The range of complexity between various medical devices and equipment does not weaken the argument against the use of the consumer expectation test. After all, while a latex glove or over-the-counter face cream do not appear complex at first glance, courts have concluded that the safety consideration and complex circumstances surrounding the design and failure of these products fall outside the “ordinary” user’s knowledge. These central issues related to “complex” products will be ignored if a jury is instructed solely (or even in the alternative) on the consumer expectation test. Stephanie A. Sheridan is a partner and Cassandra T. Holman is an associate at Sedgwick, Detert, Moran & Arnold in San Francisco, where their practices are focused on the defense of product liability claims. Sheridan was counsel for the air-bag manufacturer in the Pruitt case, which is mentioned in this article. Kevin Dunne, another partner at the firm, argued for the defense in the case that resulted in the Brown decision, which is also discussed in the article.

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