Court Opinion

ID: 9564406
Source: CourtListenerOpinion
Date Created: 2023-08-21 18:59:48.789975+00
Date Added: 2024-06-11T09:18:23.472619
License: Public Domain

Andrews, Presiding Judge,
concurring specially.
I concur with the majority’s conclusion that Bryant’s claims are not preempted by federal law. I also agree with the majority that the trial court properly granted summary judgment to Hoffmann-La Roche, Inc. (Hoffmann) on Bryant’s claims for breach of express and implied warranties, and I agree that issues of fact remain that preclude the grant of summary judgment to Hoffmann on Bryant’s claim for failure to warn. As to Bryant’s claim that the prescription drug, Posicor, was defectively designed, I concur that the grant of summary judgment in favor of Hoffmann should be reversed, but not for the reasons stated by the majority.7 As set forth below, I conclude that prescription drugs are a unique category of product, and that the risk-utility test adopted for design defect claims in Banks v. ICI Americas, Inc., 264 Ga. 732 (450 SE2d 671) (1994) (based on the general design defect test in § 2 of Restatement (Third) of Torts: Products Liability), does not apply to prescription drugs. I would adopt *412the design defect test specifically crafted for prescription drugs in § 6 (c) of the Restatement Third. Since the parties have not had an opportunity to apply the newly adopted test, I would reverse the grant of summary judgment to Hoffmann on this issue and remand the case to the trial court to allow the parties to develop their best case under the new test. This would render premature most of the dispute over whether the trial court properly excluded the testimony of Bryant’s experts. I concur with the majority that the trial court properly excluded the expert testimony to the extent it relates to whether the Food and Drug Administration (FDA) should have approved Posicor. As to whether other portions of the expert testimony are relevant to establishing Posicor was defective, I would conclude this issue should be reconsidered by the trial court on remand after the parties have had an opportunity to develop their cases under the new design defect test.
In Banks, 264 Ga. 732, the Supreme Court of Georgia adopted a new risk-utility analysis test for design defect cases based on the test set forth in § 2 of Restatement (Third) of Torts: Products Liability (the Restatement Third). Jones v. NordicTrack, Inc., 274 Ga. 115, 118 (550 SE2d 101) (2001). Bryant’s claim that a prescription drug was defectively designed is an issue of first impression in Georgia, so the Banks test has not previously been applied to prescription drugs, and there are compelling reasons to conclude that it does not apply.
Prescription drugs have historically been viewed as a category of products that present unique issues in a design defect claim. In 1965 the Restatement (Second) of Torts, § 402A recognized in comment k that some products, like prescription drugs, are unavoidably unsafe.
k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared *413and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.
(Emphasis omitted.) Restatement (Second) of Torts, § 402A, comment k. Although comment k has been widely adopted by courts which have applied § 402A to prescription drug design defect claims, most courts (as the majority opinion points out) have elected to apply the comment k protections to prescription drugs on a case-by-case basis. See Feldman v. Lederle Laboratories, 97 N.J. 429 (479 A2d 374) (1984); Conk, Is There a Design Defect in the Restatement (Third) of Torts: Products Liability?, 109 Yale L. J. 1087, 1094-1095 (2000). These courts generally hold that the protections of comment k should be limited to prescription drugs having a high degree of social need. On the other hand, a substantial minority of courts have applied comment k to hold that all prescription drugs are protected from design defect liability. Brown v. Superior Court &c. of San Francisco, 44 Cal.3d 1049 (751 P2d 470) (1988); Grundberg v. Upjohn Co., 813 P2d 89 (Utah 1991); Young v. Key Pharmaceuticals, 130 Wn.2d 160 (922 P2d 59) (Wash. 1996); In re Eli Lilly & Co., 789 FSupp. 1448 (S.D. Ind. 1992). These courts, recognizing a distinction between prescription drug products and other products, emphasize the public interest in encouraging the development and marketing of affordably priced prescription drugs despite unavoidable harm to some users, and point out that these products are obtainable only under a prescription by a physician.
When the Restatement Third was promulgated by the American Law Institute in the late 1990s it also recognized the unique nature of prescription drug products by creating a general design defect test along with a separate design defect test for prescription drugs. The general design defect test for nonprescription products is set forth in § 2 of the Restatement Third. This test, which was adopted in Banks, 264 Ga. 732, sets forth a risk-utility analysis which “balance[s] the risks inherent in a product design against the utility of the product so designed.” Jones, 274 Ga. at 115-116. The “heart” of a design defect claim under this test is “the reasonableness of selecting from among alternative product designs and adopting the safest feasible one.” Id. at 118. Under this test, a product can be found defective upon proof that, at the time the product was manufactured, a reasonable alternative design could have been used to avoid or reduce the foreseeable risks of harm presented by the product. Banks, 264 Ga. at 736-737.
The Restatement Third finds the risk-utility analysis set forth in *414§ 2 unworkable for the unique issues presented by prescription drug design defect claims and sets out a separate test for prescription drugs in § 6 (c). Section 6 (c) provides:
A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.
Under this test, a prescription drug product can be found defective upon proof that no reasonable health care providers would prescribe the drug to any class of patients. In other words, a plaintiff can prove a prescription drug was defective by showing there were safer designed prescription drugs on the market that reasonable health care providers would prescribe instead of the allegedly defective drug for all classes of patients. So like the general § 2 test, the § 6 (c) test allows a plaintiff to prove defectiveness by showing the existence of reasonable alternative designs in prescription drugs which have received FDA approval and are on the market and available to be prescribed. However, the § 6 (c) test does not allow a plaintiff to prove defectiveness by showing that the defendant manufacturer could have designed and marketed a safer prescription product that has not received FDA approval and is therefore not on the market. In this respect, § 6 (c) differs from the general § 2 design defect test, which allows proof that a manufacturer could have developed a safer alternative design that would have prevented the injury but which design was not developed or marketed. The former reporters of the American Law Institute’s Restatement Third explain why the § 6 (c) test refuses to hold a prescription drug manufacturer liable for not developing a safer alternative drug:
Such refusal rests not on deference to the FDA but on an understandable reluctance to allow courts to determine whether a proposed alternative drug would have received FDA approval. Development by a manufacturer of a safer alternative drug does not, by itself, help anyone. For physicians to prescribe such a safer drug, it must reach the market. To reach the market, a prescription drug must be approved by the FDA. Thus, the question of whether a new alternative drug should have been developed by the defendant must be recast as whether the proposed alternative drug would have won FDA approval in time to help the plaintiff. *415No court can answer that question without seeking, in some manner, to replicate the FDA approval process.
(Footnotes omitted.) Henderson and Twerski, Drug Designs Are Different, 111 Yale L. J. 151, 163-164 (2001). As the former reporters and others have noted, the FDA drug approval process is an elaborate, expensive, and time-consuming regulatory regime that includes preclinical investigation and three phases of clinical trials including small, controlled studies of healthy and diseased humans and scientific double blind studies designed to identify possible health risks or side effects associated with a new drug. Id. at 164-166; Practical Guide to Food and Drug Law and Regulation, pp. 95-102 (K. Pina & W. Pines eds. 1998). The initial process is followed by submission of a new drug application to the FDA cataloguing the history of the drug’s development and testing, which frequently consists of hundreds of thousands of pages. Henderson and Twerski, supra at 164-166. To develop and obtain FDA approval for a new drug under the entire process takes, on average, 12 to 15 years at a cost of $200 to $500 million. Id. at 165, n. 64. No court could replicate this process in a trial setting nor could any expert reliably testily that the FDA would have approved a proposed alternative drug. It follows that the different treatment accorded prescription drugs under § 6 (c) is a practical adjustment from the § 2 general risk-utility test that is appropriate to the unique nature of the products.
The prescription drug design defect test in § 6 (c) also differs from the general risk-utility test of § 2 in that it does not deem a prescription drug defective if it benefits any class of patients. Thus the test considers the welfare of the class of persons who benefit from having the prescription drug remain on the market. On the other hand, under the general § 2 risk-utility test, a product design is defective upon proof of a reasonable alternative design that could have avoided or reduced the risk of harm. Banks, 264 Ga. 732. As applied to nonprescription products, this test declares products defective and removes them from the marketplace through the tort system to protect the larger class of persons who are exposed to unreasonable risk, even though a smaller class of persons would have benefitted from continued careful use of the product. Because nonprescription products are available to everyone on the market, and it is not feasible to deny access to the product to the larger at risk class and grant access to the smaller careful class, the risk-utility test in § 2 removes the product from the market for the greater benefit of society. By contrast § 6 (c), which leaves a prescription drug on the market by refusing to deem it defective if it benefits any class of persons, recognizes that it is possible to grant access to prescription drugs to the class of persons who benefit from the product while *416denying access to the class of persons who would be harmed. This is possible because prescription drugs are not available to everyone but can be obtained only through a prescription provided by a physician, a “learned intermediary” between the purchaser and the drug manufacturer, who has the power and responsibility to prescribe the drug only to those who would benefit. Hawkins v. Richardson-Merrell, Inc., 147 Ga. App. 481, 483 (249 SE2d 286) (1978). Thus § 6 (c) recognizes that the unique nature of prescription drugs calls for a different test that attempts to maximize the benefits provided by unavoidably risky drugs and minimize the harm. Even if it is inevitable that some physicians will misprescribe a drug, this possibility remains the exception rather than the norm, and those harmed have tort remedies against negligent physicians who misprescribe despite adequate warnings provided by the drug manufacturer. If a physician misprescribes because the drug manufacturer failed to give the physician adequate warnings, then those harmed have a cause of action against the manufacturer for failure to warn. Hawkins, 147 Ga. App. at 483; Henderson and Twerski, supra at 158-174.
Although a design defect claim for prescription drug products under § 6 (c) is more difficult to prove than a design defect claim for nonprescription products under the risk-utility analysis of § 2, the Restatement Third established the more restrictive provisions of § 6 (c) for reasons that are well suited to the unique aspects of prescription products. Moreover, because a prescription drug may be found defective under § 6 (c), the Restatement Third refuses to provide the blanket protection provided to prescription drugs under comment k to § 402A of the Restatement Second. Although as the majority points out, § 6 (c) of the Restatement Third has not been widely adopted by other courts, this is not because it has been widely rejected during its brief existence — most courts have simply not had the opportunity to consider it as an alternative. The test for prescription drug design defects set forth in Restatement Third § 6 (c) establishes a better reasoned alternative to the design defect test adopted by the majority, which employs a case-by-case application of comment k as an affirmative defense in conjunction with risk-utility analysis.
Because I would adopt § 6 (c) as the test for prescription drug design defects, and the issue is one of first impression, I would remand this case to the trial court with instructions that the parties be allowed to conduct appropriate discovery and otherwise develop their respective cases under the new test. See Banks, 264 Ga. at 737.
*417Decided July 16, 2003
Bird & Associates, Wendell R. Bird, Richard L. Brittain, Jonathan T McCants, for appellants.
Nelson, Mullins, Riley & Scarborough, Richard B. North, Jr., Matthew B. Lerner, for appellee.

 Since Bryant’s negligence based design defect claim cannot be treated as a distinct theory of recovery, it need not be separately addressed. Ogletree v. Navistar Intl. Transp. Corp., 271 Ga. 644, 645 (522 SE2d 467) (1999).