* The late Honorable Oliver Seth, United States Senio r Circuit Judge, passed

away before final disposition of this appeal. “The practice of this court permits the remaining two panel judges if in agreement to a ct as a quorum in resolving the appeal.” United States v. Wiles , 106 F.3d 1516, 1516 n.* (10th Cir. 1997), petition for cert. filed , 65 U.S.L.W. 3632, (U.S. Mar. 10, 1997) (No. 96-14 30). 

## F I L E D United States Court of Appeals Tenth Circuit 

### JUN 20 1997 

### PATRICK FISHER Clerk PUBLISH UNITED STATES COURT OF APPEALS
FOR THE TENTH CIRCUIT

ALPHA EDWARDS, Personal Representative of the Estate of John T. Edwards, deceased,

Plaintiff-Appellant,

v. BASEL PHARMACEUTICALS, a division of Ciba-Geigy Corporation,

Defendant-Appellee.

---------------------------------------------- PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA, Amicus Curiae. No. 95-6176

ORDER

Before ANDERSON and BARRETT, Circuit Judges. *-2-

This matter is before the court on a petition for r ehearing with suggestion for rehearing en banc filed by defendant-appellee B asel Pharmaceuticals. For the reasons stated below, the hearing panel has conclud ed its original disposition was correct, and the remaining judges of the court in a ctive service have rejected the en banc suggestion. Some background is necessary f or a full understanding of the procedural and substantive deficiencies of the peti tion.
I Plaintiff Alpha Edwards brought this wrongful deathaction after her husband suffered a fatal heart attack while smoking cigarettes and wearing two of Basel’s “Habitrol” nicotine patches. Her theory of liability was Basel’s failure to warn of the risks of nicotine overdose resulting fr om smoking and (over)use of the patch. While a relatively thorough warning, sp ecifically noting the fatal risk realized here, was included in materials intended f or the prescribing physician, a package insert addressed to the patient failed to m ention the possibility of any fatal reaction to nicotine overdose, cautioning onl y that “[a]n overdose might cause you to faint.” Appellant’s Appendix (App.) at 45. Basel moved for summary judgment on the ground that , pursuant to the “learned intermediary rule” (LIR) recognized in Okl ahoma, see, e.g. , Tansy v. Dacomed Corp. , 890 P.2d 881, 886 (Okla. 1994), its duty to warn ran solely to the prescribing physician, who was apprised of the dang er involved. Plaintiff1 We noted that “[a]lthough the operative administrat ive regulation,

directive, or stipulation was never produced,” the FDA mandate for direct patient warnings and Basel’s compliance therewith were admi tted and uncontroverted. Edwards v. Basel Pharmaceuticals , No. 95-6176, Certification of State Law Question (Certification Order), at 2-3 (10th Cir. F eb. 28, 1996). -3- countered that the case fell within a recognized ex ception to the LIR, applicable when “the FDA has mandated that warnings be given t o the patient as well as to the physician.” McKee v. Moore , 648 P.2d 21, 25 (Okla. 1982). Basel, which represented that “the patient insert as well as the Information to Physician were both mandated and approved by the FDA,” App. at 54 n.7, contended that its compliance with the FDA mandate precluded any liabi lity premised on inadequate patient warnings. The district court granted summa ry judgment for Basel. On appeal, the parties reasserted the positions the y had urged in the district court. We recognized that the case, as framed by t he foregoing proceedings, raised an unsettled question regarding the relation ship between a satisfied FDA mandate 1 and the LIR:

Although Oklahoma courts have acknowledged the FDA-mandate exception, they have never had the occa sion to consider the effect of the manufacturer’s complianc e with the very agency mandate on which the exception rests. The c ourts that have considered the issue have followed two very differe nt lines of analysis which, though mutually exclusive, appear i nternally consistent and sound. Some courts have held that the LIR, itself an excep tion to the manufacturer’s traditional duty to warn consumers d irectly of the risks associated with any product, simply drops outof the calculus,-4-

leaving the duty of the manufacturer to be determin ed in accordance with general principles of tort law. See, e.g. , Odgers v. Ortho Pharmaceutical Corp. , 609 F. Supp. 867, 877-79 (E.D. Mich. 1985); Martin ex rel. Martin v. Ortho Pharmaceuticals , 645 N.E.2d 431, 436-37 (Ill. Ct. App. 1994); MacDonald v. Ortho Pharmaceutical Corp. , 475 N.E.2d 65, 69-71 (Mass.), cert. denied , 474 U.S. 920 (1985). Pursuant to such principles, traditional s tandards involving reasonableness govern the adequacy of warnings and, hence, compliance with a nonpreemptive and “minimal” FDA m andate (in particular, the one negating the LIR) is at most in conclusive evidence of adequacy. Odgers , 609 F. Supp. at 879; Martin , 645 N.E.2d at 437; MacDonald , 475 N.E.2d at 70. Other courts have held that the LIR remains operati ve, thus barring reversion to general duty principles, and y ields only to the extentof the FDA mandate, which carves out--and thereby delimits--an exceptional, exclusive duty owed direc tly to the consumer. Once this overriding mandate is met, the LIR “applies and acts to bar any consideration of any alleged de ficiency of the warning to the user.” Lacy v. G.D. Searle & Co. , 567 A.2d 398, 401 (Del. 1989); accordSpychala v. G.D. Searle & Co. , 705 F. Supp. 1024, 1032-33 (D.N.J. 1988). Under this view, the minimal, nonpreemptive character of FDA-mandated requirement s is simply not a consideration, because it is the LIR, not compliance with the FDA mandate, that, strictly speaking, precludes the common law consumer-warning claim. Certification Order at 3-4. We summarized the pert inent facts of record and certified the following question to the Oklahoma Supreme Court:

Under Oklahoma law, what determines the scope or extent of the prescription drug manufacturer’s duty to warn the consumer when FDA recognition of the need for direct warnings has undercut application of the learned intermediary rule? More specifically, what is the effect of the manufacturer’s compliance with the very FDA requirements invoking this exception to the rule? Id. at 1.-5-

In due course, the supreme court supplied its answe r, supporting the viability of plaintiff’s claim for inadequate consu mer warnings:

We hold that when the FDA requires warnings be give n directly to the patient with a prescribed drug, an exception to the “learned intermediary doctrine” has occurred, and t he manufacturer is not automatically shielded from liability by pro perly warning the prescribing physician. When this happens the manuf acturer’s duty to warn the consumer is not necessarily satisfied by c ompliance with FDA minimum warning requirements. The required warnings must not be misleading, and must be adequate to explain to the user the possible dangers associated with the product. Whether that duty has been satisfied is governed by the common law of the state . . . . Edwards v. Basel Pharmaceuticals , 933 P.2d 298, 303 (Okla. 1997). Implementing this definitive pronouncement of contr olling state law, we issued an order and judgment reversing the districtcourt insofar as it had granted summary judgment for Basel on plaintiff’s consumer warning claim: “The district court has never considered the adequacy of Basel’s consumer warnings under the common law of Oklahoma. Accordingly, summary judgm ent must be reversed and the case remanded for further proceedings on th at issue, consistent with the principles expressed by the state supreme court.” Edwards v. Basel Pharmaceuticals , No. 95-6176, 1997 WL 158134, at **1 (10th Cir. Ap r. 2, 1997). With respect to “plaintiff’s analytically separate claim that Basel (also) did not adequately warn the decedent’s prescribing physicia n,” however, we affirmed, agreeing with the district court that plaintiff had offered no affirmative evidence-6-

to dispute Basel’s showing that the information pro vided to the prescribing physician was accurate, appropriate, and complete. Id. One month later, Basel filed the instant petition o bjecting to the content of our certified question and to our implementation of the supreme court’s answer. Basels’ primary argument on rehearing runs as follo ws: the record failed to establish the particular source and content of the FDA mandate involved; because of this evidentiary gap, our question improperly assumed a mandate for direct patient warnings sufficient to undercut the LIR; an d, finally, this deficiency in the question left the supreme court’s answer inapplicab le to our facts. As a secondary matter, Basel argues that our question wa s inconsistent with a factual determination made by the district court.
II Before addressing the merits of Basel’s petition, i t is important to note its procedural inappropriateness. Basel (1) unequivoca lly and unqualifiedly represented to the district court that its monitory patient insert was mandated by the FDA; (2) responded to plaintiff’s resultant FDA -mandate argument notby retracting or qualifying that admission, but by rel ying on the accompanying representation, also uncontroverted, that it had satisfied the admitted mandate; and (3) did not object in any way to our certificat ion order, which posed the sole question raised by its own broad representations an d argument on the-7-

FDA-mandate question. Only now, after the supreme court has provided an unfavorable answer and we have remanded for furtherproceedings in accordance therewith, does Basel raise any objection regarding the nature of the mandate referred to in the certified question. Further, Ba sel’s challenge to our subsequent order and judgment implementing the supreme court’s answer is, in essence, really an indirect objection to the premises underl ying our certified question, premises which, as noted, Basel supplied at the out set and never called into doubt until now. To say the least, then, Basel’s present protests ar e mistimed. Indeed, even putting aside the connection to the year-old certif ication order and considering the petition solely in connection with our subsequent o rder and judgment, it is still plainly late, see Fed. R. App. P. 40(a) (specifying fourteen days fo r filing petition for rehearing), and Basel has not offered any excus e for its untimeliness. Our following discussion and rejection of the petition on the merits is intended to facilitate the proceedings on remand, which otherwi se might be complicated needlessly by some of the same contentions; we do n ot thereby condone the procedural course followed here.-8- III Basel objects that our certified question did not i dentify the particular source of the FDA mandate involved (an omission its own broad representations and subsequent silence necessitated) and therefore improperly assumed a mandate sufficient to trigger Oklahoma’s exception to the L IR. However, we did not mislead the Oklahoma Supreme Court on this point; o n the contrary, we carefully explained that our certified question was based sol ely on Basel’s general representation that its patient insert had been man dated and approved by the FDA because “the operative administrative regulation, directiv e, or stipulation was never produced.” Certification Order at 2. Hence, all that can be said is the supreme court provided a broader answer than it mig ht have had we been able to offer restrictive details of the FDA mandate involv ed--an answer indicating that the distinctions Basel now wishes to draw, making the availability of the FDA-mandate exception turn on the administrative co ntext or format of the particular mandate involved, played no part in the court’s analysis of the drug manufacturer’s duty to warn. Indeed, the court stated its holding with reference to generic FDA “requirements.” Edwards , 933 P.2d at 303. In short, the supreme court focused on the existence of a mandate for direct patient warnings, without qualification as to regul atory source, content, or form, and evinced no compunction about applying the FDA-m andate exception to the2 We grant PRMA’s motion to file the amicus curiae br ief submitted in

conjunction with Basel’s petition for rehearing. -9- circumstances of this case, in which, as we had ful ly explained, such details were lacking. Accordingly, we find no support for Basel ’s present contentions that our certified question was improper or that this case m ay involve some inferior sort of mandate outside the scope of the duty analysis set out in the supreme court’s

answer. The thrust of that duty analysis may be further cla rified in response to two objections advanced by amicus Pharmaceutical Resear ch and Manufacturers of America (PRMA). 2 PRMA argues that, contrary to our certified quest ion and the supreme court’s answer, “the FDA has expressly stat ed that patient package inserts are not intended to affect adversely the standard of civil tort liability which is imposed on drug manufacturers and dispense rs, or to define the duty or set the standard of care manufacturers owe to the patient who uses the prod uct.” Amicus Curiae Brief at 8 (citations omitted and emp hasis altered). As the emphasized terms betray, PRMA is actually complaini ng about a decision no one has made yet, regarding the requisite contentof the manufacturer’s consumer warnings. Specifically, PRMA is concerned about pr eserving the independence between state tort warning standards and particularpatient labels or inserts the FDA has mandated/approved. This has nothing to do with the analytically prior3 Moreover, whether the FDA disclaims any intent to a ffect state tort duties

(as to content or existence) is irrelevant to the c ontrolling question whether a particular state has chosen to rely on FDA mandates for such purposes. -10- question of duty vel non posed in our certification order. Indeed, the Okl ahoma Supreme Court’s answer--that the duty recognized he re is not necessarily satisfied by compliance with the FDA mandate triggering it--e ffectuates precisely the content-independence referred to in the quoted pass age. 3 PRMA displays a similar confusion in arguing that w e have mistaken the Habitrol patient insert for a “comprehensive warnin g” when it is just a “lay” admonition meant merely to complement the more exha ustive information provided to the prescribing physician. The Oklahom a Supreme Court was well aware of the difference between the prescribing phy sician’s materials and the patient insert, see Edwards , 933 P.2d at 299, but this difference did not affe ct its determination that an agency mandate requiring that some cautionary information be given directly to the patient precluded reliance on the LIR. Again, PRMA confuses the conditions creating Basel’s duty to warn with considerations relating to the content/satisfaction of that duty, a matter that simply has not been reached yet. See id. at 303 (recognizing Basel’s duty to warn consumer, but explaining “[w]hether that duty has been satisfied [under] the common law of the state . . . [is] beyond our assignment in response to this cert ified question”); Edwards , 1997 WL 158134, at **1 (this court’s order and judgment remanding to the district-11-

court, which “has never considered the adequacy of Basel’s consumer warnings under the common law of Oklahoma”). Thus, some of what PRMA has to say may be relevant to assessing the adequacy of Basel’ s consumer warnings, but it is not pertinent to the analytically prior decision, d ispositive of this appeal, that Basel had a common law duty to provide such warning s. Finally, Basel contends our disposition is inconsis tent with the district court’s statement that it “agrees with defendant th at plaintiff has not shown that the [FDA] mandated that warnings with respect to th e Habitrol System be given to the patient directly.” App. at 71 n.1. On its fac e, this statement merely acknowledges that plaintiff did not present her own evidence of FDA-mandated warnings--a fact of no analytical significance give n that the necessary mandate was admitted by Basel. Moreover, if the district c ourt intended to hold, as a matter of law, that no FDA mandate existed, that ho lding would be plainly in error, as the only evidence on the question is Base l’s unqualified admission of such a mandate. Actually, in light of the districtcourt’s initial expression of “agree[ment] with defendant,” it evidently was not making either of these points, but simply accepting Basel’s argument that, given B asel’s uncontroverted compliance with the (admitted) FDA mandate, plainti ff had presented no evidence of any FDA-mandated patient warning that Basel had not given , and, consequently, there could be no liability based the reon. While a reasonable-12-

enough approach given the blank slate the district court was writing on at the time, that is precisely the legal position now reje cted by the Oklahoma Supreme Court in response to our certified question. Obvio usly, the district court’s contrary assessment of the governing state law cann ot preempt or undermine the supreme court’s definitive pronouncement thereof. The petition is DENIED.