Gottesman and Hollis, P.A., 39 East Pearl Street, Nashua, NH 03060 I have been practicing law for almost 28 years now, and in that time, I had never handled a case that involved the negligent actions of a pharmacy. I have just completed two separate trials which involved two national chain pharmacies that resulted in verdicts for my clients. Unfortunately, the clients had to endure some very sig
In the Supreme Court of the United States On Petition for a Writ of Certiorari to the
Vermont Supreme Court
BRIEF OF AMICI CURIAE
PRODUCT LIABILITY ADVISORY COUNCIL, INC.
AND U.S. CHAMBER OF COMMERCE
IN SUPPORT OF PETITIONER
Washington, DC 20006(202) 263-3000 1615 H Street, N.W.
Washington, D.C. 20062 TABLE OF CONTENTS
The Decision Below Thwarts Important FederalPolicy By Erroneously Denying Preemptive Ef-fect To The FDA’s Approval Of Petitioner’s DrugLabel .3 A. State-law failure-to-warn liability conflicts with the FDA’s goals of preventing overwarn-ing and patchwork regulation .4 B. The decision below misconstrues the FDCA and the relevant regulation promulgatedthereunder.10 II. The Decision Below Conflicts With This Court’s A. The decision below conflicts with this Court’s decisions concerning the deference due execu-tive agencies .13 B. The decision below conflicts with this Court’s decisions concerning the effect of savingsclauses on implied preemption .16 III. This Case Is An Appropriate Vehicle For Resolv- ing A Recurring Conflict In The Lower Courts OnAn Important Issue Of Federal Statutory Interpre-tation.18 A. Certiorari should be granted in this case .18 TABLE OF CONTENTS—continued
B. At minimum, this Court should call for the TABLE OF AUTHORITIES
Auer v. Robbins, 519 U.S. 452 (1997) . 15 In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., 2006 WL 2374742 (N.D. Cal.
Aug. 16, 2006). 18 Brochu v. Ortho Pharm. Corp., 642 F.2d 652 Brooks v. Howmedica, Inc., 273 F.3d 785 Caraker v. Sandoz Pharm. Corp., 172 F. Supp. 2d Cartwright v. Pfizer, Inc., 369 F. Supp. 2d 876 Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) . 14, 16 Chicago & N.W. Transp. Co. v. Kalo Brick & Tile Christensen v. Harris County, 529 U.S. 576 (2000). 14, 15 Cipollone v. Liggett Group, Inc., Colacicco v. Apotex, Inc., 432 F. Supp. 2d Dusek v. Pfizer Inc., 2004 WL 2191804 Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189 Fidelity Fed. Sav. & Loan Ass’n v. de la Cuesta, Geier v. American Honda Motor Co., TABLE OF AUTHORITIES—continued
Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707 (1985) . 14, 15 Horn v. Thoratec Corp., 376 F.3d 163 Laisure-Radke v. Par Pharm., Inc., 2006 WL 901657 (W.D. Wash. Mar. 29, 2006). 18 Martin v. Occupational Safety & Health Review Comm’n, 499 U.S. 144 (1991) . 15 Mazur v. Merck & Co., 742 F. Supp. 239 McNellis v. Pfizer, Inc., 2006 WL 2819046 Needleman v. Pfizer, Inc., 2004 WL 1773697 Peters v. Astrazeneca, LP, 417 F. Supp. 2d 1051 Salmon v. Parke-Davis & Co., 520 F.2d 1359 Sinnot v. Davenport, 63 U.S. (22 How.) 227 (1859) . 17 Sykes v. Glaxo-SmithKline, 2007 WL 957337 In re Tetracycline Cases, 747 F. Supp. 543 United States v. Locke, 529 U.S. 89 (2000) . 2, 14 Witczak v. Pfizer, Inc., 377 F. Supp. 2d 726 Zikis v. Pfizer, Inc., 2005 WL 1126909 (N.D. Ill.
TABLE OF AUTHORITIES—continued
STATUTES, RULES AND REGULATIONS
Drug Amendments of 1962 § 202, Pub. L. 87-781, 76 New Drug and Antibiotic Regulations, 47 Fed. Reg.
New Drug and Antibiotic Regulations, 50 Fed. Reg.
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Prod-ucts, 71 Fed. Reg. 3922 (Jan. 24, 2006) . passim MISCELLANEOUS
150 Cong. Rec. H5598-5599 (July 13, 2004). 6 150 Cong. Rec. S8657 (daily ed. July 22, 2004). 6, 7 Amicus Curiae Brief of the United States of America, Dowhal v. SmithKline Beecham ConsumerHealthcare, LP, 56 P.3d 1027 (Cal. 2003) (No.
A094460), 2003 WL 23527781. 6 Amicus Curiae Brief of the United States, In re Paxil Litig., 2002 WL 31375497 (C.D. Cal. Sept. 5,2002) (No. CV 01-07937 MRP). 6, 9, 10 TABLE OF AUTHORITIES—continued
Brief for Amicus Curiae the United States of Amer- ica, Colacicco v. Apotex, Inc., 432 F. Supp. 2d514 (E.D. Pa. 2006) (No. 05-CV-05500-MMB),2006 WL 1724170. 4, 5 Brief for Amicus Curiae the United States of America, Motus v. Pfizer, Inc., 358 F.3d 659 (9thCir. 2004) (Nos. 02-55372 & 02-55498), 2002WL 32303084. 5, 6 Corrected Amicus Brief for the United States, Kallas v. Pfizer, Inc., No. 2:04CV0998 PGC (N.J. Sup.
Ct. 2005), 2005 WL 4030146. 6 James A. Henderson, Jr. & Aaron D. Twerski, Doc- trinal Collapse in Products Liability: The EmptyShell of Failure to Warn, 65 N.Y.U. L. REV. 265(1990) . 8 Lars Noah, The Imperative to Warn: Disentangling the "Right to Know" From the "Need to Know"About Consumer Product Hazards, 11 YALE J. ONREG. 293 (1994) . 12 Richard B. Stewart, Regulatory Compliance Preclu- sion of Tort Liability: Limiting the Dual-TrackSystem, 88 GEO. L.J. 2167 (2000) . 8 Statement of Interest of the United States, Bernhardt v. Pfizer, Inc., 2000 WL 1738645 (S.D.N.Y. Nov.
22, 2000) (No. 00 Civ. 4042 LLM) . 6 PRODUCT LIABILITY ADVISORY COUNCIL, INC.
AND U.S. CHAMBER OF COMMERCE
AS AMICI CURIAE IN SUPPORT OF PETITIONER
INTEREST OF THE AMICI CURIAE
Product Liability Advisory Council, Inc. (“PLAC”) is a non-profit association with 125 corporate members represent-ing a broad cross-section of American and internationalproduct manufacturers. These companies seek to contributeto the improvement and reform of the law in the UnitedStates and elsewhere, with emphasis on the law governingthe liability of manufacturers of products. PLAC’s perspec-tive is derived from the experiences of a corporate member-ship that spans a diverse group of industries in various facetsof the manufacturing sector. Since 1983, PLAC has filedover 725 briefs as amicus curiae in both state and federalcourts, including this Court, presenting the broad perspectiveof product manufacturers seeking fairness and balance in theapplication and development of the law as it affects productliability. Appendix A lists PLAC’s corporate members.
The Chamber of Commerce of the United States of America (“Chamber”) is the world’s largest business federa-tion. The Chamber represents an underlying membership ofmore than three million companies and professional organi-zations of every size, in every industry sector, and from everyregion of the country. An important function of the Chamberis to represent the interests of its members in matters beforeCongress, the Executive Branch, and the courts. To that end,the Chamber regularly files amicus briefs in cases that raiseissues of vital concern to the nation’s business community Pursuant to Rule 37.6, amici affirm that no counsel for a party authored this brief in whole or in part and that no person other thanamici and their counsel made a monetary contribution to its prepa-ration or submission. The parties’ letters consenting to the filing ofthis brief have been filed with the Clerk’s office.
PLAC and the Chamber—which have filed amicus briefs in prior preemption cases, including Geier v. AmericanHonda Motor Co., 529 U.S. 861 (2000), and United States v.
Locke, 529 U.S. 89 (2000)—are well situated to address theissue of preemption raised in this case. Their members areengaged in commerce in each of the 50 states and are subjectin varying degrees to a wide range of federal regulations. Asa result, their members often confront the interplay betweenthe duties imposed by federal law and the state common-lawstandards applied in product liability cases. Therefore, theynot only are uniquely suited to offer a broader perspective onpreemption than the parties may provide, but also are keenlyinterested in ensuring that the regulatory environment inwhich their members operate is a rational and consistent one.
INTRODUCTION AND SUMMARY OF ARGUMENT
Although this case arises in the context of federal drug regulation, its significance extends far beyond the pharma-ceutical industry. If the decision below is allowed to stand,all manufacturers of federally regulated products, regardlessof industry, will be at risk of having to choose between com-plying with federal law or complying with state law. If theydecide to comply with federal law, they will—like the peti-tioner in this case—be exposed to multimillion dollar state-law tort liability. No company should be forced to make thatchoice or to suffer those consequences.
In addition to being fundamentally unfair, the decision below impedes interstate commerce and threatens the properfunctioning of the federal regulatory system. In allowing pri-vate litigants to hold manufacturers liable under state law forfailing to include risk warnings that are contrary to thosemandated by the relevant federal agency, the Vermont Su-preme Court—expressly disregarding the agency’s views—misconstrued federal statutes and misapplied this Court’sprecedent. The results are potentially devastating. Permittingjuries in individual cases to substitute their ad hoc conclu-sions for those reached by an expert federal agency can easily upset the delicate regulatory balance struck by that agencyafter comprehensive review and careful consideration of allavailable scientific information.
Unfortunately, the Vermont Supreme Court is not alone in its error. Although some courts have correctly concludedthat approval of a drug label by the Food and Drug Admini-stration preempts state-law failure-to-warn claims, many oth-ers have reached the opposite, erroneous conclusion. Like thecourt below, they have failed to give due deference to theFDA’s authoritative interpretation of the Food, Drug andCosmetic Act (“FDCA”). As a result, the public health hasbeen endangered and the goal of national uniformity in drugregulation has been undermined.
It is vitally important that this Court grant certiorari to vindicate the Supremacy Clause and to resolve the dangeroussplit in lower court authority.
The Decision Below Thwarts Important Federal Pol-
icy By Erroneously Denying Preemptive Effect To
The FDA’s Approval Of Petitioner’s Drug Label.
The FDA is the expert federal agency charged by Con- gress with ensuring that drugs are safe and effective. To thatend, the FDCA mandates that drug manufacturers obtainFDA approval to market prescription drugs. The agency de-cides whether to approve a drug based “on a comprehensivescientific evaluation of the product’s risks and benefits underthe conditions of use prescribed, recommended, or suggestedin the labeling.” Requirements on Content and Format of La-beling for Human Prescription Drug and Biological Products,71 Fed. Reg. 3922, 3934 (Jan. 24, 2006) (“Preemption Pre-amble”) (citing 21 U.S.C. § 355(d)) (emphasis added). In-deed, [t]he centerpiece of risk management for prescrip-tion drugs generally is the labeling which reflectsthorough FDA review of the pertinent scientific evi- dence and communicates to health care practitionersthe agency’s formal, authoritative conclusions re-garding the conditions under which the product canbe used safely and effectively. FDA carefully con-trols the content of labeling for a prescription drug,because such labeling is FDA’s principal tool foreducating health care professionals about the risksand benefits of the approved product to help ensuresafe and effective use.
Ibid. (emphasis added); see also id. at 3967–3969; New Drugand Antibiotic Regulations, 50 Fed. Reg. 7452, 7470 (Feb.
22, 1985) (“Drug labeling serves as the standard under whichFDA determines whether a product is safe and effective.”).
By imposing state-law tort liability on a drug manufacturerdespite the manufacturer’s compliance with FDA labeling di-rectives, the decision below “threaten[s] FDA’s statutorilyprescribed role as the expert Federal agency responsible forevaluating and regulating drugs.” 71 Fed. Reg. at 3935.
A. State-law failure-to-warn liability conflicts with
the FDA’s goals of preventing overwarning and
The FDA’s overarching goal in regulating the warning labels of pharmaceuticals is to strike the right balance be-tween providing sufficient information to drug users and pro-viding too many, or the wrong kind of, warnings. “FDAseeks to encourage the optimal level of use in light of reason-able safety concerns, by requiring scientific evidence of anassociation between a drug and a particular hazard beforewarning of that association on a drug’s labeling.” Brief forAmicus Curiae the United States of America at 14, Colaciccov. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006) (No. 05-CV-05500-MMB), 2006 WL 1724170 (citing 21 C.F.R.
§ 201.57(e)) (“FDA Colacicco Br.”). To achieve that goal,“FDA considers not only complex clinical issues related tothe use of the product in study populations, but also impor-tant and practical public health issues pertaining to use of the product in day-to-day clinical practice.” 71 Fed. Reg. at3968. Through careful consideration of these factors, “appro-priate warnings are drafted that identify established riskswhile avoiding inadequately substantiated risks, mention ofwhich could improperly deter use of the drug to the detrimentof the very patients it is designed to benefit.” FDA ColaciccoBr. 5.
In the Preemption Preamble, the FDA emphasized how delicate and important this balance is, and how overwarningcan harm patients and interfere with regulatory goals: Given the comprehensiveness of FDA regulation ofdrug safety, effectiveness, and labeling under theact, additional requirements for the disclosure ofrisk information are not necessarily more protectiveof patients. Instead, they can erode and disrupt thecareful and truthful representation of benefits andrisks that prescribers need to make appropriatejudgments about drug use.
71 Fed. Reg. at 3935; accord FDA Colacicco Br. at 13 (“Inconsidering the agency’s views on drug labeling, it is criticalto understand that, where warnings are concerned, more isnot always better.”). Among other dangers, “[e]xaggerationof risk could discourage appropriate use of a beneficialdrug.” 71 Fed. Reg. at 3935. Moreover, “labeling that in-cludes theoretical hazards not well-grounded in scientificevidence can cause meaningful risk information to ‘lose itssignificance.’” Ibid. (quoting 44 Fed. Reg. 37,434, 37,447(June 26, 1979)). Thus, “State-law attempts to impose addi-tional warnings can lead to labeling that does not accuratelyportray a product’s risks, thereby potentially discouragingsafe and effective use of approved products or encouraginginappropriate use and undermining the objectives of the act.”Ibid.; see also, e.g., Brief for Amicus Curiae the UnitedStates of America at 23–24, Motus v. Pfizer, Inc., 358 F.3d659 (9th Cir. 2004) (Nos. 02-55372 & 02-55498), 2002 WL32303084 (explaining that “[u]nder-utilization of a drug based on dissemination of scientifically unsubstantiatedwarnings, so as to deprive patients of beneficial, possiblylifesaving treatment, could well frustrate the purposes of fed-eral regulation as much as over-utilization resulting from afailure to disclose a drug’s scientifically demonstrable ad-verse effects”) These concerns were echoed not long ago in a letter en- tered in the Congressional Record from five former ChiefCounsel of the FDA, whose tenures date back to 1972. Thatletter debunked allegations that the FDA had gone “‘in aradical new direction’” by arguing in its amicus brief in Mo-tus that failure-to-warn claims are preempted by the FDCA.
150 Cong. Rec. S8657 (daily ed. July 22, 2004) (quoting 150Cong. Rec. H5598-5599 (July 13, 2004)); accord 150 Cong.
Rec. E1505 (July 22, 2004). These former FDA Chief Coun-sel, who served in both Republican and Democratic admini-strations, explained that, in arguing for preemption, the The briefs filed by the FDA in Colacicco and Motus are just two of the numerous amicus briefs supporting implied preemption filedby the FDA since 2000. In each case in which it has filed anamicus brief, the FDA was concerned about some aspect of civillitigation that posed a specific threat to its authority. See, e.g., Cor-rected Amicus Brief for the United States, Kallas v. Pfizer, Inc.,No. 2:04CV0998 PGC (N.J. Sup. Ct. 2005), 2005 WL 4030146(arguing that failure-to-warn claim was preempted by FDA rejec-tion of scientific basis for warning); Amicus Curiae Brief of theUnited States of America, Dowhal v. SmithKline Beecham Con-sumer Healthcare, LP, 56 P.3d 1027 (Cal. 2003) (No. A094460),2003 WL 23527781 (state-mandated statement on smoking cessa-tion product preempted where FDA had concluded that statementshould not appear); Amicus Curiae Brief of the United States, In rePaxil Litig., No. CV 01-07937 MRP (C.D. Cal. Sept. 5, 2002)(state-law injunction against FDA-approved advertising pre-empted); Statement of Interest of the United States, Bernhardt v.
Pfizer, Inc., 2000 WL 1738645 (S.D.N.Y. Nov. 22, 2000) (No. 00Civ. 4042 LLM) (state-law injunctive relief to force changes indrug labeling and issuance of “Dear Doctor” letters preempted).
“amicus curiae briefs filed by [the United States] * * * pro-tect FDA’s jurisdiction and the integrity of the federal regula-tory process” because, “[i]f every state judge and jury couldfashion their own labeling requirements for drugs and medi-cal devices, there would be regulatory chaos for these twoindustries that are so vital to the public health, and FDA’sability to advance the public health by allocating scarce spacein product labeling to the most important information wouldbe seriously eroded.” 150 Cong. Rec. S8657.
Courts and commentators alike have acknowledged the wisdom of preserving FDA primacy in reviewing and ap-proving labeling for products over which it has regulatory au-thority. When the Third Circuit held in Horn v. ThoratecCorp., 376 F.3d 163 (3d Cir. 2004), that the FDA’s pre-market approval process for medical devices preempts statecommon-law claims alleging defective design and manufac-ture, the court relied upon the agency’s conclusion that“‘State common law tort actions threaten the statutoryframework for the regulation of medical devices, particularlywith regard to FDA’s review and approval of product label-ing.’” Id. at 178 (quoting the Letter Brief of Amicus Curiaethe United States of America at 25) (emphasis added). Simi-larly, in Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir.
2001) (en banc), cert. denied, 535 U.S. 1056 (2002)—a fail-ure-to-warn case involving the labeling of a medical deviceapproved by the FDA—the Eighth Circuit identified a number of sound reasons why the FDA may preferto limit warnings on product labels. Warnings aboutdangers with less basis in science or fewer hazardscould take attention away from those that presentconfirmed, higher risks. A label with many variedwarnings may not deliver the desired information tousers. Space on product labeling material is also afactor, and the most effective labels are those withlarge, bold warnings and a simple design.
None of these concerns is likely, however, to motivate— or even be considered by—a jury that is asked to decide astate failure-to-warn claim. All that such a jury would becalled upon to determine is whether the content of the defen-dant’s label satisfied the defendant’s state-law duty to warnof the particular risk encountered by the particular plaintiff.
If the jury answers that question in the negative, liability isalmost certain to attach, regardless of the potential impactthat the addition of that warning might have on other warn-ings with respect to other risks or on other patients’ ability orwillingness to use the product.
This problem is exacerbated by the case-by-case process of common-law adjudication. Later judges or juries cannotreconsider outcomes reached in earlier cases. Thus, a trier offact cannot deem unnecessary or inappropriate a warningadded in response to an earlier verdict. Nor do judges and ju-ries know how many warnings will be vying for limitedreader attention.
That is precisely the role of the FDA. As the Eighth Cir- cuit has emphasized, “[i]t would be difficult for a jury fo-cused on a single case to take into account ‘the cumulative,systemic effects’ of a series of verdicts. In contrast, the FDApossesses a broader perspective.” Brooks, 273 F.3d at 797(quoting Richard B. Stewart, Regulatory Compliance Preclu-sion of Tort Liability: Limiting the Dual-Track System, 88GEO. L.J. 2167, 2175 (2000)). Even where a judge or jury isaware of potential overwarning, it can do little to prevent theproblem. See James A. Henderson, Jr. & Aaron D. Twerski,Doctrinal Collapse in Products Liability: The Empty Shell ofFailure to Warn, 65 N.Y.U. L. REV. 265, 302 (1990).
In light of these widely recognized dangers, the FDA has reasonably determined that state-law “product liability law-suits have directly threatened the agency’s ability to regulatemanufacturer dissemination of risk information for prescrip-tion drugs in accordance with the act.” 71 Fed. Reg. at 3934.
As the agency summarized in the Preemption Preamble: State actions are not characterized by centralizedexpert evaluation of drug regulatory issues. Instead,they encourage, and in fact require, lay judges andjuries to second-guess the assessment of benefitsversus risks of a specific drug to the general pub-lic— the central role of FDA—sometimes on behalfof a single individual or group of individuals. Thatindividualized reevaluation of the benefits and risksof a product can result in relief—including the threatof significant damage awards or penalties—that cre-ates pressure on manufacturers to attempt to addwarnings that FDA has neither approved nor foundto be scientifically required. This could encouragemanufacturers to propose “defensive labeling” toavoid State liability, which, if implemented, couldresult in scientifically unsubstantiated warnings andunderutilization of beneficial treatments.
Id. at 3935. Only comprehensive, exclusive regulation by anexpert agency, such as the FDA, can solve the problem ofoverwarning by permitting an overall evaluation of risk and arational decision about what risks are sufficiently serious towarrant inclusion on a label, how those warnings should bephrased, and where they should be placed. This is especiallytrue where, as here, the intended readership consists not ofordinary consumers, but, under the learned-intermediary doc-trine, highly trained physicians who make judgments basedon scientific data and information.
In addition to the danger of overwarning created when states require warnings not approved by the FDA, state regu-lation via failure-to-warn claims clashes with “the need fornational uniformity in product regulation.” Brooks, 273 F.3dat 797. As the FDA has noted, if judgments under state lawwere allowed to trump the FDA’s assessment of what mayappear in drug advertisements, “the public undoubtedlywould receive inconsistent information from region to re-gion.” Amicus Curiae Brief of the United States at 5, In re Paxil Litig., 2002 WL 31375497 (C.D. Cal. Sept. 5, 2002)(No. CV 01-07937 MRP).
This Court has likewise recognized in the context of an- other federal labeling regime—the Federal Cigarette Label-ing and Advertising Act of 1965—that the national economycan be greatly burdened if manufacturers of a product soldaround the country are subjected to “diverse, nonuniform,and confusing * * * labeling and advertising regulations.”Cipollone v. Liggett Group, Inc., 505 U.S. 504, 514 (1992).
Congress, in the legislative history of the Medical DeviceAmendments to the FDCA (“MDA”), observed that, “if asubstantial number of differing requirements applicable to amedical device are imposed by jurisdictions other than theFederal government, interstate commerce would be undulyburdened.” H.R. REP. NO. 853, 45 (1976) (quoted in Brooks,273 F.3d at 797). For these reasons, it was reasonable for theFDA to conclude that, [i]f State authorities, including judges and juries ap-plying State law, were permitted to reach conclu-sions about the safety and effectiveness informationdisseminated with respect to drugs for which FDAhas already made a series of regulatory determina-tions based on its considerable institutional expertiseand comprehensive statutory authority, the federalsystem for regulation of drugs would be disrupted.
71 Fed. Reg. at 3969. Not only would allowing plaintiff’sclaims to proceed in this case open the door to the burdeningof interstate commerce in prescription drugs, but it alsowould set a precedent that could affect other federally-regulated industries.
B. The decision below misconstrues the FDCA and
the relevant regulation promulgated thereunder.
The decision below—which expressly disregards the considered views of the FDA (see Pet. App. 26a)—rests on afundamental misunderstanding of the FDCA and the relevant regulation promulgated thereunder. According to the Ver-mont Supreme Court, plaintiff’s failure-to-warn claim doesnot conflict “with the FDA’s labeling requirements for Phen-ergan because defendant could have warned against IV-pushadministration without prior FDA approval, and because fed-eral labeling requirements create a floor, not a ceiling, forstate regulation.” Pet. App. 6a. The Vermont Supreme Courtis mistaken. Its decision rests on a false premise.
Contrary to what the court found, Wyeth was not at lib- erty to change the Phenergan label after its approval by theFDA. As the dissenting opinion explains, the applicable“regulation does not allow manufacturers to simply reassessand draw different conclusions regarding the same risks andbenefits already balanced by the FDA.” Pet. App. 40a. Seealso Pet. 19. Rather, that regulation, 21 C.F.R. § 314.70(c),permits a manufacturer to make a provisional label changeonly if there is newly discovered evidence of a previouslyunknown or underappreciated risk. As the FDA articulatedwhen proposing § 314.70(c), the rule is designed to “makeavailable important new information about the safe use of adrug product.” New Drug and Antibiotic Regulations, 47Fed. Reg. 46622, 46635 (proposed Oct. 19, 1982) (emphasisadded). In this case, however, there was no new information.
The risks associated with arterial blood exposure to Phener-gan were fully known by the FDA when it approved thePhenergan label. See Pet. 6–8. Indeed, in 1997, at the conclu-sion of a multiyear administrative review of the Phenerganlabel, the FDA—with specific reference to the risk of “Inad-vertent Intra-arterial Injection”—expressly directed Wyeth to“[r]etain [the] verbiage in [the] current label.” Pet. App.
162a. Accordingly, Wyeth was not permitted to change thelabel without prior FDA approval.
As the FDA explained in the Preemption Preamble, the view (adopted by the court below) that “FDA labeling re-quirements represent a minimum safety standard” that maybe augmented by more stringent state-law requirements is a “misunderstanding” of the FDCA and the regulations prom-ulgated “[o]verwarning, just like underwarning, can similarly have anegative effect on patient safety and public health,” require-ments imposed by the FDA pursuant to the FDCA “establishboth a ‘floor’ and a ‘ceiling.’” Id. at 3935. Thus, contrary tothe decision below, allowing state law to require an addi-tional warning beyond those required by the FDA would“frustrate the agency’s implementation of its statutory man-date.” Id. at 3934.
It would, moreover, place manufacturers in an impossi- ble position. If subject to state-law failure-to-warn claims,drug manufacturers will be forced to add every conceivablewarning to their labels or else risk—as in this case—multimillion dollar tort liability. At the same time, however,because “the determination whether labeling revisions arenecessary is, in the end, squarely and solely FDA’s under theact” (71 Fed. Reg. at 3934), adding warnings to drug labelswithout FDA approval would expose manufacturers to ad-ministrative enforcement actions (and even criminal prosecu-tion under 21 U.S.C. §§ 331, 333, 352).In some cases,manufacturers might respond to this dilemma by withdraw-ing certain products from the market, thereby diminishing in- Furthermore, in what can fairly be called a Catch-22, adding warnings in response to potential tort liability might even increasea manufacturer’s vulnerability to tort claims. As one commentatorhas suggested, “[i]t seems to be only a matter of time before aplaintiff succeeds in bringing an inadequate warning claim prem-ised on the argument that, although a completely accurate state-ment of the risk had been provided, the pertinent warning lackedsufficient prominence because it was lost among the clutter of toomany other cautionary statements on the label.” Lars Noah, TheImperative to Warn: Disentangling the “Right to Know” From the“Need to Know” About Consumer Product Hazards, 11 YALE J.
ON REG. 293, 379–380 (1994); see also id. at 380 n.435 (describ-ing similar cases in various contexts).
terstate commerce and depriving the public of drugs that theFDA had determined to be safe and effective.
II. The Decision Below Conflicts With This Court’s
The FDA’s interpretation of the FDCA is clear: Because state-law failure-to-warn tort claims interfere with theagency’s expert determinations as to the proper balance to bestruck in drug labels, “FDA approval of labeling under theact * * * preempts conflicting or contrary State law.” 71 Fed.
Reg. at 3934. In reaching the opposite conclusion, the Ver-mont Supreme Court acknowledged the FDA’s position, butdeclined to give it any weight, holding that “the FDA’sstatement deserves no deference.” Pet. App. 26a. The Ver-mont Supreme Court’s failure to defer to the FDA’s interpre-tation of the FDCA is contrary to this Court’s precedent.
A. The decision below conflicts with this Court’s de-
cisions concerning the deference due executive
Under the Supremacy Clause of the United States Con- stitution, Congress may preempt state statutory or commonlaw through federal legislation. See U.S. CONST. art. VI, cl.
2; Chi. & N.W. Transp. Co. v. Kalo Brick & Tile Co., 450U.S. 311, 326–327 (1981). It is well settled that federal regu-lations implementing such statutes “have no less pre-emptiveeffect than federal statutes” themselves. Fid. Fed. Sav. &Loan Ass’n v. de la Cuesta, 458 U.S. 141, 153 (1982).
In the course of delineating the circumstances in which preemption exists, this Court has held that a federal statute orregulation impliedly preempts any state law (including anystate common law) that would “prevent or frustrate the ac-complishment of a federal objective.” Geier, 529 U.S. at873–874; see also Locke, 529 U.S. at 109 (preemption is im-plied “when the state law stands as an obstacle to the accom-plishment and execution of the full purposes and objective ofCongress”) (internal quotation marks and citation omitted).
When, as in the case of the FDA, Congress has delegated au-thority to an expert federal agency to implement and enforcea federal regulatory scheme, the agency’s determination thatstate law threatens to upset federal objectives “is dispositive* * * unless either the agency’s position is inconsistent withclearly expressed congressional intent, * * * or subsequentdevelopments reveal a change in that position.” HillsboroughCounty v. Automated Med. Labs., Inc., 471 U.S. 707, 714–715 (1985) (citation omitted).
This deference to an agency’s interpretation of the pre- emptive scope of a federal statute or regulation that theagency administers derives from the seminal decision inChevron U.S.A., Inc. v. Natural Resources Defense Council,Inc., 467 U.S. 837 (1984). As the Court explained in Chev-ron, administrative deference inheres in the congressionaldecision to delegate powers to the agency: The power of an administrative agency to adminis-ter a congressionally created * * * program neces-sarily requires the formulation of policy and themaking of rules to fill any gap left, implicitly or ex-plicitly, by Congress. If Congress has explicitly lefta gap for the agency to fill, there is an express dele-gation of authority to the agency to elucidate a spe-cific provision of the statute by regulation. Such leg-islative regulations are given controlling weightunless they are arbitrary, capricious, or manifestlycontrary to the statute. Sometimes the legislativedelegation to an agency on a particular question isimplicit rather than explicit. In such a case, a courtmay not substitute its own construction of a statu-tory provision for a reasonable interpretation madeby the administrator of an agency. Id. at 843–844 (citations and internal quotation marks omit-ted; emphasis added). Thus, under Chevron, “a court mustgive effect to an agency’s regulation containing a reasonableinterpretation of an ambiguous statute.” Christensen v. Har- ris County, 529 U.S. 576, 586–587 (2000). That same abso-lute deference is accorded to “an agency’s [reasonable] con-struction of its own regulations.” Martin v. OccupationalSafety & Health Review Comm’n, 499 U.S. 144, 150 (1991)(citation omitted).
In this instance, the FDA is, pursuant to the FDCA, “the expert Federal agency responsible for evaluating and regulat-ing drugs.” 71 Fed. Reg. at 3935. See also 21 U.S.C.
§ 393(b)(2)(B) (the FDA is to ensure that “human * * * drugsare safe and effective”). As such, it has adopted—in the Pre-emption Preamble and numerous amicus briefs (see supra atn.—an authoritative interpretation of the FDCA and theagency’s own regulations according to which “FDA approvalof labeling under the act * * * preempts conflicting or con-trary State law.” 71 Fed. Reg. at 3934. That determination—based on the agency’s recognition that state-law failure-to-warn claims interfere with its ability to implement finely cali-brated labeling decisions under the FDCA—is reasonable,and entitled to full deference.
The fact that the FDA has articulated its preemption de- termination in a regulatory preamble and a series of amicusbriefs does not diminish the deference owed that determina-tion. As this Court recognizes, an agency’s conclusion thatfederal law preempts state law may properly be communi-cated in “regulations, preambles, interpretive statements andresponses to comments.” Hillsborough County, 471 U.S. at718 (emphasis added). Similarly, the fact that the “agency’sfair and considered judgment on the matter in question” isconveyed “in the form of a legal brief” does not make theagency’s view “unworthy of deference.” Auer v. Robbins,519 U.S. 452, 462 (1997). See also Geier, 529 U.S. at 883(deferring to agency interpretation of ambiguous regulationcontained in amicus brief submitted in dispute between pri-vate parties).
It was, therefore, contrary to this Court’s precedent for the Vermont Supreme Court to disregard the FDA’s authori- tative determination that FDA approval of a drug label pre-empts state-law tort claims premised on the manufacturer’sfailure to provide a warning not required by the FDA.
B. The decision below conflicts with this Court’s de-
cisions concerning the effect of savings clauses on
The Vermont Supreme Court’s erroneous failure to defer to the FDA’s interpretation of the FDCA rests, in part, onthat court’s misunderstanding of this Court’s preemption ju-risprudence.
Recognizing that “deference to an agency’s interpreta- tion is appropriate only when a statute is ‘silent or ambiguouswith respect to the specific issue’ the agency has considered,”Pet. App. 25a (quoting Chevron, 467 U.S. at 842–843), theVermont Supreme Court disregarded the FDA’s interpreta-tion of the FDCA because, in that court’s opinion, (a) drugmanufacturers can add warnings required by state common-law standards on their own initiative without violating federalregulations, and (b) Congress, in a savings clause, expresslylimited implied preemption in the drug context to situationsin which compliance with federal and state law is a physicalimpossibility. See Pet. App. 21a, 26a–28a. But neither prem-ise is correct. The first rests on the court’s misunderstandingof 21 C.F.R. § 314.70(c), which—contrary to the decisionbelow—does not give drug manufacturers the power to addwarnings unilaterally absent new, scientifically valid infor-mation. See supra at . The second rests on the court’s mis-interpretation of this Court’s implied preemption doctrine.
Section 202 of the 1962 amendments to the FDCA pro- vides that “[n]othing in the amendments made by this Act tothe Federal Food, Drug, and Cosmetic Act shall be construedas invalidating any provision of State law * * * unless thereis a direct and positive conflict between such amendmentsand such provision of State law.” Drug Amendments of 1962§ 202, Pub. L. 87-781, 76 Stat. 780, 793 (1962). In the eyes of the Vermont Supreme Court, this provision “remove[d]from [its] consideration the question of whether common-lawtort claims present an obstacle to the purposes and objectivesof Congress.” Pet. App. 21a. That conclusion, however, iscontrary to this Court’s precedent.
As this Court made clear in Geier, “‘conflicts’ that pre- vent or frustrate the accomplishment of a federal objectiveand ‘conflicts’ that make it ‘impossible’ for private parties tocomply with both state and federal law” are equally repug-nant to the Supremacy Clause. 529 U.S. at 873. Accordingly,this Court has steadfastly “refused to read general ‘saving’provisions”—such as Section 202—“to tolerate actual con-flict both in cases involving impossibility and in ‘frustration-of-purpose’ cases.” Id. at 874 (citations omitted). Becauseany form of conflict between federal and state law is intoler-able to the Supremacy Clause, this Court rejects “attemptingto distinguish among types of federal-state conflict for pur-poses of analyzing whether such a conflict warrants pre-emption in a particular case.” Ibid.
That, however, is precisely what the Vermont Supreme Court did below. It interpreted Section 202 as abrogatingstate law only when simultaneous compliance with federallaw is impossible, but as preserving state law even if it “pre-sent[s] an obstacle to the purposes and objectives of Con-gress.” Pet. App. 21a. Neither the Supremacy Clause nor thisCourt’s precedent permits such a result Notably, the language used by Congress in Section 202 to de- scribe which state laws are preempted—namely state laws that arein “direct and positive conflict” with federal law—is identical tothat used by this Court in Sinnot v. Davenport, 63 U.S. (22 How.)227, 243 (1859). In that case, this Court held that a state law,which imposed a registration requirement on steamboats beyondthat imposed by a federal law meant to facilitate interstate trans-port, was preempted even though simultaneous compliance withboth state and federal law was not impossible. Thus, Sinnot makesclear that the phrase “direct and positive conflict” encompasses III. This Case Is An Appropriate Vehicle For Resolving
A Recurring Conflict In The Lower Courts On An
Important Issue Of Federal Statutory Interpretation.
A. Certiorari should be granted in this case.
As acknowledged by both the majority and dissenting opinions below (see Pet. App. 11a–13a; Pet. App. 23a; Pet.
App. 39a n.7; see also Pet. 16–17), the lower courts aredeeply divided on whether the FDCA preempts state-law tortclaims alleging that an FDA-approved drug label failed toprovide adequate warning. Compare, e.g., Sykes v. Glaxo-SmithKline, 2007 WL 957337 (E.D. Pa. Mar. 28, 2007) (no-tice of appeal filed Mar. 29, 2007) (holding state-law failure-to-warn claims preempted); In re Bextra & Celebrex Mktg.
Sales Practices & Prod. Liab. Litig., 2006 WL 2374742(N.D. Cal. Aug. 16, 2006) (same); Needleman v. Pfizer, Inc.,2004 WL 1773697 (N.D. Tex. Aug. 6, 2004) (same); Dusekv. Pfizer Inc., 2004 WL 2191804 (S.D. Tex. Feb. 20, 2004)(same); Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189(D.N.D. 2002) (same), aff’d on other grounds, 367 F.3d 1013(8th Cir. 2004); with, e.g., Laisure-Radke v. Par Pharm.,Inc., 2006 WL 901657 (W.D. Wash. Mar. 29, 2006) (holdingstate-law failure-to-warn claims not preempted); Peters v.
Astrazeneca, LP, 417 F. Supp. 2d 1051 (W.D. Wis. 2006)(same); Cartwright v. Pfizer, Inc., 369 F. Supp. 2d 876 (E.D.
Tex. 2005) (same); Zikis v. Pfizer, Inc., 2005 WL 1126909(N.D. Ill. May 9, 2005) (same); Witczak v. Pfizer, Inc., 377F. Supp. 2d 726 (D. Minn. 2005) (same); Caraker v. SandozPharm. Corp., 172 F. Supp. 2d 1018 (S.D. Ill. 2001) (same);Mazur v. Merck & Co., 742 F. Supp. 239 (E.D. Pa. 1990)(same).Indeed, one recent decision—holding, contrary to situations in which state law, although not physically incompatiblewith federal law, nonetheless impedes attainment of the federalstatutory objective.
5 As noted by the FDA in the Preemption Preamble, the Vermont Supreme Court is not the only lower court to have mistakenly con- the decision below, that state-law tort claims such as thosebrought by plaintiff are impliedly preempted under theFDCA—expressly recognizes the “many conflicting courtdecisions on this topic.” Colacicco v. Apotex, Inc., 432 F.
Supp. 2d 514, 518 (E.D. Pa. 2006), appeal docketed, No. 06-3107 (3d Cir. June 21, 2006). See also McNellis v. Pfizer,Inc., 2006 WL 2819046, at *12 (D.N.J. Sept. 29, 2006) (reaf-firming decision holding that state-law failure-to-warn claimsare not preempted but certifying issue for interlocutory ap-peal given acknowledged “split in authority”), appeal dock-eted, No. 06-5148 (3d Cir. Dec. 27, 2006).
The question of FDCA preemption is an extremely im- portant one. It directly affects tens of thousands of cases thatare currently pending. See Pet. 13 n.4. Moreover, it impli-cates substantial policy issues affecting both public healthand interstate commerce (in the pharmaceutical industry andbeyond). See supra at Although there is, as of yet, no circuit split on the issue, this Court should not delay its resolution of the deep divisionbelow. Given, on the one hand, the clearly erroneous decisionof the Vermont Supreme Court, and, on the other hand, thecompelling arguments in favor of preemption, a conflict be-tween a state court of last resort and a United States court ofappeals on this important federal question seems highlylikely, if not inevitable, as the many pending cases percolateupwards. Awaiting the probable circuit split before decidingthe issue would have deleterious consequences: Courts willbe burdened with large numbers of cases that should neverhave been filed, let alone allowed to go to trial; pharmaceuti- strued FDA drug labeling requirements as setting only a floor, butnot a ceiling, for state regulation of pharmaceuticals. See 71 Fed.
Reg. at 3934–3935 (citing, inter alia, Brochu v. Ortho Pharm.
Corp., 642 F.2d 652 (1st Cir. 1981); Salmon v. Parke-Davis &Co., 520 F.2d 1359 (4th Cir. 1975); In re Tetracycline Cases, 747F. Supp. 543 (W.D. Mo. 1989)).
cal manufacturers will be caught in an inescapable dilemma,forced to choose between complying with federal law andcomplying with conflicting state law; and the public healthwill be endangered as juries impose unsubstantiated warningsthat obscure valid warnings and possibly deter patients fromaccepting effective treatments.
This case presents the Court with an ideal vehicle for re- solving the persistent conflict over FDCA preemption ofstate-law tort claims. The judgment below depends entirelyon the resolution of the federal statutory question. There is noindependent state ground to sustain the judgment below ifthis Court holds that plaintiff’s tort claims are preempted un-der the FDCA. Furthermore, this case presents a factual re-cord devoid of the confounding issues that often afflict simi-lar cases. There is, for example, no evidence or allegationthat Wyeth concealed information from the FDA or failed tocomply with FDA regulations when obtaining FDA approvalof the Phenergan label. Moreover, after a multiyear reviewthat addressed the danger of inadvertent intra-arterial injec-tion in particular, the FDA specifically directed Wyeth to re-tain the Phenergan label.
B. At minimum, this Court should call for the views
of the Solicitor General.
In an effort to avoid and correct erroneous decisions such as that below, the FDA has filed numerous amicusbriefs in courts around the country. See supra at . Ifasked, the federal government would likely be eager to offerthis Court its expert opinion on the scope of implied preemp-tion under the FDCA as well as whether review of the issueis warranted. Accordingly, given the deep division in thelower courts and the tremendous importance of the issue pre-sented, it would be appropriate for this Court, at minimum, tocall for the views of the Solicitor General in this case.
The petition for a writ of certiorari should be granted.
Washington, DC 20006(202) 263-3000 1615 H Street, N.W.
Washington, D.C. 20062(202) 463-5337 APPENDIX
Corporate Members of the
Product Liability Advisory Council
(as of April 2, 2007)
Andersen Corporation Anheuser-Busch Companies Continental Tire North America, Inc.
Engineered Controls International, Inc.
Harley-Davidson Motor Company The Heil Company International Truck and Engine Corporation Mercedes-Benz of North America, Inc.
Mitsubishi Motors North America, Inc.
Hessische Fachvereinigung für Diabetes e.V. (HFD) Sitz: Giessen Gründungsdatum: 14.08.1996 Vorsitzender: Prof. Dr. med. Hermann-Joachim Glaser Abteilung für Allgemeine Innere Medizin und Gastroenterologie Herz-Jesu-Krankenhaus Buttlarstr. 74 36039 Fulda Stv. Vorsitzende: Dr. med. Cornelia Marck Giessener Str. 12 35415 Pohlheim Schatzmeister : Michael Simonsohn Mainzer Landstr. 2