Stephen G. Blitch and Pamela A. Schock co-authored this article. Stephen G. Blitch is a director in the Oakland office of Crosby, Heafey, Roach & May. Pamela A. Schock was an associate in the firm's Los Angeles office.

For more than 30 years, section 402A of the Restatement (2nd) of Torts has served as the primary summary of U.S. product liability law. Last May, the American Law Institute approved revisions to this section in the form of the Restatement (3rd) of Torts: Products Liability. This new restatement does not, of course, establish the law of any jurisdiction, and it remains to be seen if courts will embrace its concepts. Rather, as its name suggests, the Restatement (3rd) summarizes the current state of the law.

By adding "Products Liability" to a title within the restatement, the authors acknowledge the importance that this genre of tort law has assumed in the past three decades. While this restatement version retains the essence of decades of black-letter law, there are five areas of change that are of particular importance to the product liability practitioner.

• The Restatement (3rd) clarifies in section 2 the well-accepted doctrine that a product liability claim must be based on one of three product defects: manufacturing, design or inadequate warnings. The type of defect alleged is significant, because only a manufacturing defect gives rise to strict liability, while liability for products that are defective because of design or inadequate instructions or warnings rests on a reasonableness standard.

• The Restatement (3rd) shifts proof of design defect away from the consumer-expectation test to a risk-vs.-benefit analysis. Section 2(b) replaces comments (g) and (i) of section 402A and provides a definition of "design defect." While section 402A emphasized the duty to meet consumers' expectations of safety – and a manufacture's responsibility for creating such expectations – the new restatement says a product is defective in design when the product is "not reasonably safe" to begin with, and its "foreseeable risks" could have been reduced or avoided by a "reasonable alternative design."

This reasonableness test adopts the risk-vs.-utility balance that most jurisdictions apply, weighing such factors as the likelihood and seriousness of harm against the utility of the product, the feasibility of a safer alternative design and the availability of substitute products. See §&#nbsp2 cmt.&#nbsp(d).

The new restatement further requires that a plaintiff prove that the alternative design was reasonable and could have been adopted before the allegedly defective product was manufactured and sold. Moreover, the plaintiff is required to prove that the alternative design would have also made the product safer – not just that it would have eliminated the risk of the plaintiff's particular injury. Thus, an alternative design will not be sufficient if it has dangers equal to or greater than the original design. The plaintiff is not required to go so far as to produce a prototype of the alternative product and may instead rely on qualified expert testimony. See §&#nbsp2 cmt.&#nbsp(f).

The reasonableness standard in warnings cases similarly requires an independent assessment of the advantages and disadvantages of the warning given, as well as an assessment of alternative warnings and instructions. Comment (i) to section 2 suggests that factors such as whether the product contains warnings about trivial risks or whether the product contains too many warnings should be considered in determining whether the warning or instruction is defective.

In line with the analysis of the California Supreme Court in Carlin v. Superior Court, 13 Cal. 4th 1104 (1996), there is no duty to warn or instruct a health-care provider or a product's user of risks that should be obvious or are generally known. However, the product's manufacturer must provide warnings for nonobvious risks, and such warnings must be given to all users, consumers and "others who a reasonable seller should know will be in a position to reduce or avoid the risk of harm." In certain circumstances, this could even include "vivid and unambiguous warnings" on products intended for use by children.

• The Restatement (3rd) sets out a manufacturer's post-sale duties. While section 2 focuses on what a manufacturer could and should have done before selling a product, section 10 sets limits on when a manufacturer can be sued for conduct after the product has been sold. Similar to the requirements of section 2, a manufacturer's post-sale duty to warn is based on a reasonableness test: When the manufacturer knows the product poses a substantial risk and can identify the affected consumers in order to warn them, and when the "risk of harm is sufficiently great to justify the burden of providing a warning," the post-sale duty to warn is triggered. In such cases, the manufacturer must warn of risks whether or not the risks were known when the product was sold.

In addition to creating a "reasonableness standard" of care for post-sale warnings, section 11 of the new restatement makes clear that a manufacturer does not have to recall a product unless a statute or government regulation specifically requires it. Because recall efforts are a significant burden on manufacturers, comment (a) to section 11 suggests that governmental agencies are best equipped to determine whether a recall actually is needed. However, according to comment (c), a manufacturer or seller who voluntarily withdraws a product must act "reasonably," and may be held liable, for example, for an incomplete recall.

• The Restatement (3rd) specifies separately the criteria for liability for drug and medical device manufacturers. In 1964, when section 402A of the Restatement (2nd) of Torts was adopted, drugs and medical devices were relegated to comment status. In the oft-cited comment (k) to section 402A, the Restatement (2nd) recognized an exception to strict liability for design defect for "unavoidably unsafe products," such as drugs and medical devices. In California, comment (k) has been held to insulate all Food and Drug Administration-approved prescription drugs from strict liability for design defect. See Brown v. Superior Court, 44 Cal. 3d 1049 (1988).

While section 6 of the new restatement reflects these legal traditions and acknowledges the unique risks and benefits of drugs and medical devices, it significantly narrows the insulation of comment (k). For example, Section 6(c) requires a plaintiff to show that a product's foreseeable risks outweigh its therapeutic benefit by so much that a reasonable medical provider would not have prescribed the product for any class of patients.

It is not clear at this time whether a plaintiff will simply be able to produce a "reasonable health care provider" to testify that they would not prescribe the product for any class of patients in order to prove the liability of a manufacturer.

• The Restatement (3rd) suggests in section 6 possible exceptions to the "learned intermediary" rule, which traditionally provides that a pharmaceutical manufacturer satisfies its duty to warn by informing the patient's health care provider of a medicine's risks. While the rule was retained in section 6(d)(1), the new restatement sets out possible exceptions when no health care provider has a significant role in evaluating the hazards of using the drug or medical device. In those situations, comment (e) states that the manufacturer may have a duty to warn the patient directly.

The new restatement also leaves the door open to additional exceptions. For instance, when a manufacturer provides information directly to consumers – either because the FDA requires a direct warning or the manufacturer advertises directly to the consumer as part of its marketing campaign – comment (e) suggests that "developing case law" may create other appropriate exceptions to the learned intermediary rule.

The Restatement (3rd) also expands the people to whom warnings regarding the risks inherent in drugs and medical devices must be given. Section 6(d)(1) requires that the manufacturer warn not only the prescribing physician, but also "other health care providers who are in the position to reduce the risks of harm in accordance with the instructions or warnings." This applies to any health-care provider – feasibly even a nurse practitioner – who might advise the patient about the risks of using a certain drug or medical device.

The restatement's new treatment of product liability law already has engendered significant comment, both pro and con. The breadth and depth of this commentary reflects the status of the restatement as a source for determining existing law and for shaping future developments in the law. It is often the first stopping point for advocates, courts and commentators alike. Indeed, the reformulation of its product liability principles reflects considerable input from all three of these groups. Because of its widespread notoriety and influence, product liability practitioners would do well to become familiar with the new restatement's provisions in order to gain perspective on the current state of product liability law and the public policies that underlie that area of practice.