Court Opinion

ID: 9608348
Source: CourtListenerOpinion
Date Created: 2023-08-22 03:10:57.344947+00
Date Added: 2024-06-11T11:27:45.237419
License: Public Domain

OPALA, Justice,
dissenting in part.
The court pronounces that whenever the federal Food and Drug Administration’s [FDA] safety regulations require warnings to be given directly to a user of prescription drugs, (a) an exception is to be recognized to the “learned-intermediary doctrine”1 and (b) *304a manufacturer’s failure to give the required warning may render the drug “unreasonably dangerous”. Today’s opinion teaches that (a) the FDA sets minimum standards for drug manufacturers’ design and warnings, and (b) although, in some circumstances, compliance with FDA regulations may satisfy all state-law requirements, adherence to FDA regulations does not generally discharge the manufacturer’s duty. Resting its pronouncement on the rationale that state common-law norms control the standards that govern the duty to warn [where liability is not preempted by federal law], the court concludes that (a) the manufacturer is not automatically shielded from liability by imparting a warning to the physician, and (b) a manufacturer’s common-law duty to warn directly the consumer-patient is not necessarily met by compliance with the FDA minimum warning requirements. The common-law duty to warn, the court explains, requires that the consumer be adequately informed of the dangers associated with the product’s use.
I would declare today that Oklahoma’s common law follows the proposed (but not yet adopted) text of the Restatement (Third) of Torts: Products Liability2 and its pertinent comments. Inasmuch as in cases that are not federally pre-empted the proposed Restatement leaves each jurisdiction free to shape the outer limit of liability, I would announce that because compliance with a nonpre-emptive federally required warning constitutes no more than evidence of the manufacturer’s reasonable conduct, it may not by itself be regarded as a liability-defeating defense.
I strongly disagree with the concuree who regards federal pre-emption as unrelated to the certified question before us. Some FDA rules are deemed preemptive.3 When preemption stands declared, there will be no room left for applying state law to gauge a federally prescribed warning’s adequacy.
I
FEDERAL PRE-EMPTION, PARTIAL OR TOTAL, MUST INDEED BE ADDRESSED IN DEALING WITH LAW THAT IS TO GOVERN IN THE SCENARIO DESCRIBED BY THE CERTIFYING COURT
Federal pre-emption is fairly comprised within the certified question before us. This is so because the claim’s scenario calls for a dichotomous division of its legal treatment. In one subclass there would be (a) cases affected by pre-emption (and hence totally or partially excluded from state-law impact) and in another (b) those that are unaffected by pre-emption and hence governed exclusively by state law.
In the first category, a manufacturer’s showing of compliance with the FDA requirement that warning be given directly to the patient may take the case completely out of the state-law reach.4
*305Comment e, Restatement (Third) of Torts: Products Liability § 7,5 states in pertinent part:
“... [I]n federal pre-emption the court decides as a matter of federal law that the relevant federal statute or regulation reflects, expressly or impliedly, the intent of Congress to displace state law, including state tort law, with the federal statute or regulation. The question of preemption is thus a question of federal law and a determination that there is preemption nullifies otherwise operational state law.
The complex set of rules and standards for resolving questions of federal preemption are beyond the scope of this Restatement. However, when federal preemption is found, the legal effect is clear. Federal preemption replaces the tort law of all states with a uniform body of federal law regulating the relevant area of product safety. Federal preemption takes one or more of three different forms. First, a federal statute may by its terms expressly preempt state law. Second, a federal statute which does not expressly preempt state law may otherwise reveal the intent of Congress to occupy the regulatory field. Third even in the absence of an express preemption clause or congressional intent to occupy the field completely, a federal law preempts all state laws with which it is in actual conflict. An actual conflict exists when the application of state law frustrates the accomplishment of congressional objectives, as when it is impossible to comply with both the state and federal law and when the state law interferes with the accomplishment of the full purposes of Congress. Judicial deference to federal product safety statutes or regulations occurs not because the court concludes that compliance with the statute or regulation shows the product to be nondefective; the issue of defectiveness under state law is never reached. Rather, the court defers because, when a federal statute or regulation is preemptive, the Constitution mandates federal supremacy.” (Emphasis added.)
There are some FDA rules that federal jurisprudence treats as absolutely preemptive.6 When this form of pre-emption stands declared, all state law is displaced. None may be interposed.
II
THE OUTER LIMIT OF LIABILITY IN CLAIMS THAT ARE NOT FEDERALLY PRE-EMPTED
According to § 8(b), Restatement (Third) of Torts: Products Liability, a drug or medical device is defective if at the time of sale or other distribution it (1) contains a manufacturing defect, (2) is not “reasonably safe due *306to defective design”, or (3) is not “reasonably safe due to inadequate instruction or warnings”.7 Warnings should be given directly to patients when the manufacturer is aware that no medical provider will be in a position to play the role of the learned intermediary.8 The Restatement has left to developing case law to resolve whether other exceptions to the learned intermediary rule should be recognized9 I accede to this view.
Section 7(b) of the Restatement10 addresses the question of what effect, if any, should be given to a manufacturer’s compliance with a nonpre-emptive federal product safety statute or regulation upon the contested issue of product defectiveness.11 Subsection (b) follows the traditional view that most product safety statutes or regulations generally set only minimum standards.12 The proposed Restatement takes no position upon the par *307rameters of liability in cases where state law governs and there has been compliance with the prescribed nonpre-emptive warnings directly to the patient.13 Though not yet adopted, the current draft appears to rest on sound principles. I would hence hold that today’s jurisprudence fills the gap left open by the proposed Restatement.
*306"In connection with liability for defective design or inadequate instructions or warnings:
⅜* * * 4: * *
(b) a product's compliance with an applicable product safely statute or regulation is properly considered in determining whether the product is defective with respect to the risks sought to be reduced by the statute or regulation, but such compliance does not preclude as a matter of law a finding of product defect." (Emphasis added.)
*307Since the proposed Restatement leaves each jurisdiction free to shape the outer limit of liability, I would declare that compliance with a prescribed nonpre-emptive direct warning serves as proof of a manufacturer’s reasonable conduct, but cannot ordinarily be invoked as a liability-defeating defense. To overcome the proof of compliance with the prescribed direct warning the plaintiff need not show more than that the warning (a) did not by itself make the product reasonably safe for use by the intended consumer or (b) was not adequate under the circumstances. The parties in litigation would thus stand free to contest whether (a) the product itself and/or (either or both) (b) the prescribed manner of its application under the warnings that were given may be regarded as reasonably safe.
The task of analyzing today’s answer for its application to this case must be deferred to the certifying court.14 If that court should decide that FDA regulations in suit are indeed pre-emptive, no state law is invocable. If they are not to be deemed pre-emptive, our answers will apply.
SUMMARY
I would adopt today as the common law of OHahoma the pertinent text of the proposed Restatement (Third) with the relevant comments. Because the proposed Restatement leaves OHahoma free to shape the outer limit of liability to be borne by a manufacturer who has given the patient the prescribed nonpre-emptive direct warning, I would treat its compliance with that regulatory or statutory requirement as no more than proof of the manufacturer’s reasonable conduct.
In the scenario submitted by the certifying court, the effect of federal pre-emption must be taken into account. If the pertinent regulation is to be accorded pre-emptive force — -a question beyond state law’s control — a manufacturer’s showing of compliance with the FDA requirement that warning be given directly to the patient will take the case entirely out of the reach of OHahoma’s common-law norms.

. The learned intermediary rule "holds that manufacturers of prescription drugs discharge their duty of care to patients by warning the healthcare providers who prescribe and use the drugs to treat them.” Reporters' Note, Comment d, § 8, Restatement (Third) of Torts: Products Liability (Proposed Final Draft (Preliminary Version) October 18, 1996). The American Law Institute (ALI) has undertaken the process of drafting the Restatement (Third) of Torts: Products Liability. *304James A. Henderson, Professor, Cornell Law School, and Aaron D. Twerski, Professor, Brooklyn Law School, have been selected as reporters for the project.

. Comment e, § 7, Restatement (Third) of Torts: Products Liability (Proposed Final Draft (Preliminary Version) October 18, 1996).

Several drafts of the third Restatement have been released: a preliminary draft in April 1993; Council Draft No. 1 in September 1993, Council Draft No. 2, was released September 2, 1994. The most recent version (and the one discussed here), Proposed Final Draft (Preliminary Version) was released October 18, 1996.

. See Medtronic, Inc. v. Lohr, - U.S. -, -, 116 S.Ct. 2240, 2253-2254, 135 L.Ed.2d 700 (1996).

. Comment b, § 8, Restatement (Third), supra note 1, states in part:
" * * * The rules imposing liability on a manufacturer for inadequate warning or defective design of prescription drugs and medical devices assume that compliance with a governmental regulatory standard has not preempted the imposition of tort liability. Where such preemption is found as a matter of law, liability cannot attach when the manufacturer has complied with the applicable regulatory standard. See § 7. The doctrine of pre-emption based on supremacy of federal law should be distinguished from the proposition that compliance with statutory and regulatory standards satisfies the state's requirement for product safely.” (Emphasis supplied.)
Comment e, § 8, Restatement (Third), supra note 1, states in part:
“ * * * Where the content of the warnings is mandated or approved by a governmental agency regulation and a court finds that compliance with such regulation federally preempts tort lia*305bility, then no liability under this Section can attach..." (Emphasis supplied.)

. Comment e, § 7, Restatement (Third), supra note 2.

. The U.S. Constitution, art. VI, cl. 2, makes the laws of the United States "the supreme Law of the Land; ... any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” When Congress acts within the scope of its constitutionally delegated authority, the supremacy clause empowers Congress "to pre-empt state laws to the extent it is believed that such action is necessary to achieve its purposes.” City of New York v. Federal Communications Comm’n, 486 U.S. 57, 63, 108 S.Ct. 1637, 1642, 100 L.Ed.2d 48 (1988). Likewise, Congress may delegate regulatory authority to an administrative agency, and when the agency acts within the scope of that authority, it may pre-empt and "render unenforceable state or local laws that are otherwise not inconsistent with federal law." Id., quoting from Louisiana Pub. Setv. Comm'n v. Federal Communications Comm’n, 476 U.S. 355, 369, 106 S.Ct. 1890, 1898-99, 90 L.Ed.2d 369 (1986); Fidelity Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 153-54, 102 S.Ct. 3014, 3022-23, 73 L.Ed.2d 664 (1982). Pre-emption is a matter of congressional intent and may occur in four distinct instances; (1) by express statutory language; (2) by a pervasive regulatory scheme which infers the presence of congressional intent that the federal regulation did not need supplemental state-law provisions; (3) when an actual conflict between state and federal laws makes it impossible to comply with both; or (4) where the objectives and purposes of Congress are thwarted by state law. City of New York, supra, 486 U.S. at 64, 108 S.Ct. at 1642; Fidelity Federal Sav. & Loan Ass’n, supra, 458 U.S. at 153, 102 S.Ct. at 3022. See also Lewis v. Sac and Fox Tribe of Oklahoma Housing Authority, Okl., 896 P.2d 503, 510-511 (1995); Todd v. Frank’s Tong Service, Inc., Okl., 784 P.2d 47, 49 (1989); Missouri-Kansas-Texas R. Co. v. State, Okl., 712 P.2d 40, 46-47 (1985).

. Section 8(d), Restatement (Third), supra note 1, states:
(d) A prescription drug or medical device is not reasonably safe because of inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:
(1) prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or
(2) the patient when the manufacturer knew or had reason to know that no health care provider would be in a position to reduce the risks of harm in accordance with the instructions or warnings.

. The Reporters' Note, Comment e (direct warning to patients), § 8, Restatement (Third), supra note 1, explains that many of the cases in this category deal with vaccines administered en masse at public health clinics. See, e.g., Givens v. Lederle, 556 F.2d 1341 (5th Cir.l977)(applying Florida law); Reyes v. Wyeth Laboratories., 498 F.2d 1264 (5th Cir.l974)(applying Texas law); Brazzell v. United States, 788 F.2d 1352 (8th Cir.l986)(swine flu vaccine); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir.1968). See also Allison v. Merck and Co., Inc., 110 Nev. 762, 878 P.2d 948, 959 (1994), where the court states that “although a manufacturer may decide to assign its duty to warn of the unsafeness of its product [a vaccine] to others [in the case, i.e., the Center for Disease Control], a manufacturer cannot be relieved of ultimate responsibility for assuring that its unsafe product is dispensed with a proper warning.”

. Comment e, § 8, Restatement (Third), supra note 1; Reporters' Note, Comment e, § 8, Restatement (Third), supra note 1.

. Section 7(b), Restatement (Third), supra note 2, states:

. Comment e, § 7, Restatement (Third), supra note 2, states in pertinent part:
" * * * An important distinction must be drawn between the subject addressed in Subsection (b) [supra note 10] and the matter of federal preemption of state products liability law. Subsection (b) addresses the question of whether and to what extent, as a matter of state tort law, compliance with product safety statutes or regulations affects liability for product defectiveness. When a court concludes that a defendant is not liable by reason of having complied with safety design or warnings statutes or regulation, it is deciding that the product in question is not defective as a matter of law of that state. The safety statute or regulation may be a federal provision, but the decision to give it determinative effect is a state law determination [in nonpre-emptive cases]. . . .
Accordingly, Subsection (b) addresses the effects of compliance with a federal statute or regulation found to be nonpre-emptive. It addresses the question, under state law, of the effect that compliance with product safety statutes or regulations — federal or state — should have on the issue of product defectiveness. Subsection (b) reflects the traditional view that the standards set by most product safety statutes or regulations generally are only minimum standards. Thus, most product safety statutes or regulations establish a floor of safety below which product sellers fall only at their peril, but they leave open the question of whether a higher standard of product safety should be applied. This is the general rule, applicable in most cases.* 4 * " (Emphasis supplied.)

. See Comment e, § 7, Restatement (Third), supra note 11. See also Reporters’ Note, Comment e, § 7, Restatement (Third), supra note 2, which states that "[t]he overwhelming majority of jurisdictions hold that [generally] compliance with product safety regulation is relevant and admissible ... but is not necessarily controlling.” (Emphasis supplied.) The Reporters' Note cites O'Gilvie v. International Playtex, Inc., 821 F.2d 1438 (10th Cir.1987); Sours v. General Motors Corp., 717 F.2d 1511, 1517 (6th Cir.1983); Foyle *307v. Lederle Laboratories, 674 F.Supp. 530, 533 (E.D.N.C.1987); Brooks v. Beech Aircraft Corp., 120 N.M. 372, 902 P.2d 54, 63 (1995); Washington State Physicians Ins. Exchange & Assoc, v. Fisons Corp., 122 Wash.2d 299, 858 P.2d 1054 (1993). The Reporters’ Note observes that ”[i]n holding compliance with product safety regulations is nonconclusive, courts often indicate that such safety regulations are merely ‘minimum standards.’" For this notion, the Reporters' Note cites Feldman v. Lederle Laboratories, 132 NJ. 339, 625 A.2d 1066 (1993); Plenger v. Alza Corp., 11 Cal.App.4th 349, 362, 13 Cal.Rptr.2d 811 (1992); Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107 Cal.Rptr. 45, 507 P.2d 653 (1973), and states that "[ajlthough the great majority of courts find conformance with product safety regulations nonconclusive on the issue of defectiveness, courts occasionally recognize special circumstances in which the opposite conclusion is justified." (Emphasis supplied.) Among the cases cited are Lorenz v. Celotex Corp., 896 F.2d 148 (5th Cir.1990); Ramirez v. Plough, Inc., 6 Cal.4th 539, 25 Cal.Rptr.2d 97, 863 P.2d 167, 176 (1993); Dentson v. Eddins & Lee Bus Sales, 491 So.2d 942, 944 (Ala.1986).

. See Comment e, § 7, Restatement (Third), supra note 11.

. See, e.g., Shebester v. Triple Crown Insurers, 974 F.2d 135, 137 (10th Cir.1992).