Court Opinion

ID: 9630229
Source: CourtListenerOpinion
Date Created: 2023-08-22 10:05:53.781148+00
Date Added: 2024-06-11T18:07:34.536221
License: Public Domain

CAVANAUGH, Judge,
concurring:
I JOIN the majority decision, and would supplement it with the following two comments.
I.
Both the appellant and the appellees find support for their positions in Comment k of the Restatement (Second) of Torts, as do the Majority and the Dissenting Opinions. This is particularly true of the Dissenting Opinion, which quotes extensively from Comment k to support its analysis and suggests that the Majority Opinion misreads it.
*147Pennsylvania has “adopted” section 402A of the Restatement (Second) of Torts, of which Comment k is a part. However, by this we do not mean that we should attempt to divine the meaning of each adopted section as if it were ordained doctrine. “Even where this Court has “adopted” a section of the Restatement as the law of Pennsylvania, the language is not to be considered controlling in the manner of a statute.” Coyle v. Richardson-Merrell, Inc., 526 Pa. 208, 212, 584 A.2d 1383, 1385 (1991). Moreover, we often adopt a Restatement section on our own terms, and reflect its spirit rather than the literal language. Lorah v. Luppold Roofing Co., 424 Pa.Super. 439, 447 n. 3, 622 A.2d 1383, 1387 n. 3 (1993).1
While it may seem counter-intuitive that two or more substantively different readings of Comment k can be made, Comment k is ambiguous and can legitimately be read to support both the Majority Opinion and the Dissenting Opinion. See Brown v. Superior Court (Abbott Laboratories), 44 Cal.3d 1049, 1069 n. 11, 245 Cal.Rptr. 412, 424 n. 11, 751 P.2d 470, 482 n. 11 (1988) (language of Comment k unclear). Thus, while I do feel it advances our inquiry to a limited extent, it does not provide us with with an answer to what Comment k should mean to the practitioners in this jurisdiction. I would rely on the the explication of case law in the Majority Opinion, which accurately denotes the tenor of Pennsylvania law in regards to allegedly defective prescription drugs vis-a-vis Comment k.
II.
The Majority Opinion, as indicated supra, correctly declares the tenor of Pennsylvania law in this area. I wish to add an *148additional rationale why section 402(A) of the Restatement should not be applied to cases involving allegedly defective prescription drugs.
In Azzarello v. Black Bros. Co., Inc., 480 Pa. 547, 391 A.2d 1020 (1978), the Pennsylvania Supreme Court recognized, en route to fashioning a jury instruction in products liability cases, that the judiciary plays an important role in determining the efficacy of a product in a strict liability case. In Azzarello, the Supreme Court addressed the appropriateness of instructing the jury that it had to determine in a products liability case whether that product was “unreasonably dangerous.” Id. at 551, 391 A.2d at 1023. The Court felt that the term “unreasonably dangerous” was not appropriate for a jury instruction. Id. at 556, 391 A.2d at 1025. The Court distinguished between the role of the judiciary and the role of the jury in a products liability case. Id. at 558, 391 A.2d at 1026. While a jury is competent in resolving a dispute as to the condition of a product, it does not have the institutional capacity to decide whether the product’s condition justifies placing liability on the supplier in the first place. Id. As the Court stated:
Should an ill-conceived design which exposes the user to the risk of harm entitle one injured by the product to recover? Should adequate warnings of the dangerous propensities of an article insulate one who suffers injuries from those propensities? When does the utility of a product outweigh the unavoidable danger it may pose? These are questions of law . and their resolution depends on social policy. Restated, the phrases “defective condition” and “unreasonably dangerous” as used in the Restatement formulation are terms of art invoked when strict liability is appropriate. It is a judicial function to decide whether, under plaintiffs averment of the facts, recovery would be justified; and only after this judicial determination is made is the cause submitted to the jury to determine whether the facts of the case support the averments of the complaint.
The Court went on to state, in light of the court’s role in determining the policy considerations of a product’s efficacy, *149that the sole inquiry for the jury was whether the product left the supplier’s control lacking any element to make it safe for its intended use. Id. at 559, 391 A.2d at 1027.
In light of Azzarello, I believe that it is not only appropriate, but mandated by our Supreme Court that the judiciary, as opposed to juries, consider the policy implications of applying section 402A of the Restatement to a particular product. See, e.g., Fitzpatrick v. Madonna, 424 Pa.Super. 473, 623 A.2d 322 (1993). However, the tenor of the Dissenting Opinion is that the jury is the proper entity responsible for determining whether a product is “unavoidably unsafe.” The Dissenting Opinion states near the end of its analysis as follows:
However, even if evidence was offered at trial to show that the prescription drug at issue was “unavoidably unsafe” as described in Comment k, such a determination should be for a jury to make and use when assessing the adequacy of the warnings provided. If a jury determined that a drug is experimental or that it is known to be unsafe but of great utility, the jury would then have to determine if such facts accompanied the product. Absence the inclusion of these warnings, strict liability would apply.
Dissenting Opinion at 874. The Dissenting Opinion makes no reference to the Azzarello requirement that a court, before applying sections 402A of the Restatement, consider whether the plaintiffs averments of fact justify recovery in light of public policy. Thus, it appears that the Dissenting Opinion would abdicate to a jury the responsibility for weighing the social benefits and costs of a particular product. I believe that not only would this be an explicit rejection of Azzarello’s pronouncements, but as a matter of public policy, particularly in reference to prescription drugs, it is unsound.
Two important, interrelated, public policy considerations exist for treating a prescription drug different than other manufactured products. First, prescription drugs are (potentially) inherently dangerous products whose costs are considered by society to be more beneficial than its potential harm. Second, the Food and Drug Administration (“FDA”) has the institutional capacity and legislative mandate for weighing the *150costs and benefits for particular pharmaceuticals. These considerations underlie our special treatment of prescription drugs, see, e.g., Leibomtz v. Ortho Pharmaceutical Corp., 224 Pa.Super. 418, 307 A.2d 449 (1973), and militate strongly that we find that negligence rather than strict liability as the appropriate standard for determining whether the manufacturer has adequately warned of a prescription drug’s risk.
The first important policy consideration in this area is that prescription drugs are inherently dangerous products which are considered, ex ante, beneficial to society as a whole. Unlike most manufactured products, prescription drugs are considered dangerous. When not properly dispensed, prescription drugs can cause sickness or even death. Consequently, society has heavily regulated their use, such that they can be taken only when prescribed and monitored by a physician. Despite their inherently dangerous nature, we tolerate their use because the gain for society as a whole outweighs the risk that they may harm particular individuals. Unlike most other manufactured products, prescription drugs play a significant a role in dissipating suffering and in prolonging human life. While the downside of using prescription drugs is that, even under a physician’s care, an individual can have an adverse reaction, their use is considered beneficial to society as a whole.
The second policy consideration in this area is that the FDA has a particular institutional capacity to determine whether a pharmaceutical’s health benefits outweigh its risks. Congress has created a regulatory agency, the FDA, to “protect consumers from dangerous products.” United States v. Sullivan, 332 U.S. 689, 696, 68 S.Ct. 331, 335, 92 L.Ed. 297 (1948). In approving a new drug application, the FDA balances the “expected therapeutic gains” against the “risks entailed by its use.” United States v. Rutherford, 442 U.S. 544, 555, 99 S.Ct. 2470, 2477, 61 L.Ed.2d 68 (1979). Before a new drug is approved, federal law requires (1) preliminary evaluation of a pharmaceutical’s chemical and therapeutic properties; (2) testing in animal models; (3) detailed protocols for testing in humans; (4) double-blind, placebo-controlled testing on sever*151al hundred persons; and (5) at least two long-term clinical trials including large groups of patients to assess safety, effectiveness and optimal dosage. See 47 Fed.Reg. 46,622, et seq. (Oct. 19, 1982); 48 Fed.Reg. 26,720, et seq. (June 9, 1983); 21 U.S.C. §§ 301, et seq. (1988).
This agency not only has the responsibility, but the resources, to fulfill its mission of balancing the risks against the benefits of particular pharmaceuticals. The application is reviewed by many types of health professionals who work within the FDA’s National Center for Drugs and Biologies, including physicians, pharmacologists, chemists, and microbiologists. 47 Fed.Reg. 46626 (Oct. 19,1982). The recommendation of the health professionals is in turn reviewed by management personnel within the National Center for Drugs and Biologies before a final decision is made on the drug’s application. Id. After the application is approved, the FDA has a process for monitoring adverse reactions to an approved pharmaceutical, as federal regulations mandate that all adverse reactions to a pharmaceutical be reported to the agency. 21 C.F.R. § 314.80(b). A drug manufacturer typically spends millions of dollars in developing or testing new drugs. See Drug Price Competition and Patent Term Restoration Act: Hearing Before the Senate Comm, on Labor and Human Resources, 98th Cong.2d Sess. 106 (1984).
Based on the above, I would accordingly find that public policy is best served by not applying the doctrine of strict liability to prescription drugs. Prescription drugs are inherently dangerous products which benefit society. Moreover, a federal agency exists which is devoted to weighing the known benefits and costs of marketing a particular drug. A rule of law which held a pharmaceutical company bound for unforeseeable reactions to their products, notwithstanding the FDA’s significant oversight of a drug’s approval, would stifle the incentive to produce new products. The FDA is in a unique position to make the decision whether a drug is efficacious, and to preserve the incentive for a company to produce a beneficial pharmaceutical. Juries and the judiciary do not have the requisite knowledge, resources, or societal mandate *152to make the decision as to a prescription drug’s relative worth. Accordingly, the relevant inquiry is and should be the reasonableness of a pharmaceutical company’s conduct, as a pharmaceutical manufacturer should not be the insurer against all possible consequences in light of the policy considerations supra.
As indicated by Azzarello, whether a product is “unreasonably dangerous” is a question of social policy that is within the province of the judiciary. In the peculiar instance of prescription drugs, social policy is best served by not holding bound a drug manufacturer for a prescription drug’s unforeseen consequences absent negligence. Our holding today does not totally insulate from liability a drug manufacturer. Far from it. Rather, it only absolves a drug manufacturer of being held strictly liable for a defective product. We have found that the doctrine of negligence provides to the consumer a high degree of protection in a prescription drug products liability case. Incollingo v. Ewing, 444 Pa. 263, 287,282 A.2d 206, 219 (1971); White v. Weiner, 386 Pa.Super. 111, 562 A.2d 378, 384 (1989), aff'd. 525 Pa. 572, 583 A.2d 789 (1991). Our ruling today serves the needs of society by balancing the need to provide incentive for new prescription drug production with protecting the consuming public.
ROWLEY, President Judge, joined both Majority Opinion and CAVANAUGH’S, J., Concurring Opinion.
CAVANAUGH, J., filed a Concurring Opinion and joined Majority Opinion.
BECK, J., joined both Majority Opinion and CAVANAUGH’S, J., Concurring Opinion.

. A major problem that I find with certain Restatement sections is a lack of clarity. This problem is well-illustrated by Comment k, which allows the reader to supply his or her own interpretation due to the vaguery of its language. This in turn may be part-and-parcel to the Restatement's attempt on the one hand to summarize the law in our several states and at the same time to predict the direction it will take. Lorah, supra; see also Grundberg v. Upjohn Co., 813 P.2d 89, 95 (Utah 1991) (recognizing that Restatement both summarizes and predicts the direction of the law); Keyes, The Restatement (Second); Its Misleading Quality and a Proposal for Its Amelioration, 13 Pepperdine Law Review 23 (1985).