Opinion
No. 10-729.
Dated: November 30, 2010.
BARRY L. DAVIS, Counsel of Record, KATHLEEN M. O'CONNOR, HOLLY S. HARVEY, THORNTON, DAVIS FEIN, P.A., Attorneys for Petitioner.
BARRY L. DAVIS Counsel of Record.
KATHLEEN M. O'CONNOR HOLLY S. HARVEY THORNTON, DAVIS FEIN, P.A. Brickell BayView Centre, Attorneys for Petitioner.
QUESTION PRESENTED
Over-the-counter ("OTC") drug products that comply with all mandatory conditions described in a "Final Monograph" are recognized as "safe and effective and not misbranded." 21 C.F.R § 330.1. The specific warnings for all OTC Final Monograph drugs are authored by the Food and Drug Administration ("FDA"), and codified into law. Id. Warnings "shall be in the exact language" established in an applicable OTC Final Monograph. 21 C.F.R. § 330.1(c)(2). The Federal Food, Drug, and Cosmetic Act ("FDCA") section entitled "National Uniformity for Nonprescription Drugs" provides that no state may establish any requirement that is "different from or in addition to, or that is otherwise not identical with," a requirement of the FDCA. 21 U.S.C. § 379r.
The question presented is whether federal law, which imposes a strict set of labeling requirements on manufacturers of Final Monograph OTC drugs, including mandatory product warnings authored by the FDA, pre-empts state-law product liability actions premised on theories of failure to warn.
LIST OF ALL PARTIES
Appellants in the Court Below
Armando Valdes, III, Incapacitated, by and through his legal guardians, Armando Valdes, Jr, and Violetta Valdes;
Armando Valdes, Individually
Violetta Valdes, Individually
Appellee in the Court Below
McNeil-P.P.C. Inc. CORPORATE DISCLOSURE STATEMENT
McNeil-P.P.C., Inc. is a wholly owned subsidiary of Johnson Johnson.
TABLE OF CONTENTS
Wyeth v. Levine PAGE QUESTION PRESENTED....................... i LIST OF ALL PARTIES...................... ii CORPORATE DISCLOSURE STATEMENT................................ iii TABLE OF CONTENTS........................ iv TABLE OF APPENDICES...................... vii TABLE OF CITED AUTHORITIES............... ix OPINIONS BELOW........................... 1 JURISDICTION............................. 1 PERTINENT CONSTITUTIONAL, STATUTORY, AND REGULATORY PROVISIONS............................. 1 INTRODUCTION............................. 1 STATEMENT OF THE CASE ................... 1 A. Factual Background.................... 8 1. FDA Regulatory Regime for OTC Drugs.......................... 8 2. FDA's Final Monograph Regulation of OTC Nasal Decongestants...................... 14 3. The Operative FDA Warning Label ............................. 16 B. Proceedings Below .................... 17 1. The Trial Court Proceedings ....... 17 2. The Appeal to the Third District Court of Appeal of Florida ........................... 19 3. The Appeal to the Supreme Court of Florida .................. 21 REASONS FOR GRANTING THE PETITION ........................... 22 I. The Court Should Grant Review to Correct Florida's Rejection of Impossibility Conflict Preemption in a Case Where, Unlike the NDA Regulatory Scheme, the OTC Final Monograph Regulatory Regime Does Not Contain a Provision that Would Allow a Product Manufacturer to Unilaterally Change its Product Labeling by Adding Warnings that Were Not Approved by the FDA ........ 22 II. The Court Should Grant Review to Resolve the Issue of Whether State Failure-to-Warn Claims Against OTC Final Monograph Drug Manufacturers Stand as an Obstacle to National Uniformity ..... 25 III. The Court Should Grant Review to Clarify the Confusion Stemming from Overbroad Applications of by Lower Courts .. 31 CONCLUSION ............................. 33TABLE OF APPENDICES
Valdes v. Optimist of Suniland, et al. 21 C.F.R. § 341.80 21 C.F.R. § 330.10 21 C.F.R. § 330.1 21 U.S.C. § 379r Food and Drug Administration Modernization and Accountability Act of 1997 OTC Facts and Figures Listing of Over the-Counter/Consumer Drug Manufacturers Drug Applications for Over-the-Counter Drugs Pseudoephedrine Product List PAGE Appendix A — Opinion of the Third District Court of Appeal, Filed December 30, 2009 ........................ la Appendix B — Decision of the Third District Court of Appeal Denying Rehearing, Filed February 23, 2010 ........................ 6a Appendix C — Decision of the Supreme Court of Florida Denying Review, Filed August 2, 2010 ............................. 8a Appendix D — Order of the Circuit Court of the Eleventh Judicial Circuit Granting McNeil-P.P.C., Inc.'s Motion for Final Summary Judgment, Filed May 14, 2008 ................................... 10a Appendix E — Final Summary Judgment of the Circuit Court of the Eleventh Judicial Circuit in Favor of McNeil-P.P.C., Inc., Filed June 9, 2008 ............................. 14a Appendix F — Complaint, , Case No. 0309855 CA 20, in the Circuit Court of the Eleventh Judicial Circuit in and for Miami-Dade County, Florida, Filed April 23, 2003 .................. 17a Appendix G — Constitutional Provision Involved, United States Constitution, Article VI, Clause 2 ........................... 52a Appendix H — Statutory and Regulatory Provisions .......................... 54a .......................... 69a ........................... 88a ............................ 97a Appendix I — , Senate Report No. 105-43 (1997) (excerpt) ............................... 101a Appendix J — Tylenol Cold and Tylenol Flu Labels ..................................... 128a Appendix K — Consumer Healthcare Products Association, (2001) .................... 130a Appendix L — Drug InfoNet, - ......................... 132a Appendix M — FDA, (last updated April 26, 2010) ................................ 137a Appendix N — State of Indiana, Criminal Justice Institute, .......................... 141aTABLE OF AUTHORITIES
Demahy v. Actavis 593 F.3d 428 Dowhal v. SmithKline Beecham Consumer Healthcare 88 P.3d 1 Florida Avocado Growers v. Pault 373 U.S. 132 Geier v. American Honda Motor Co. 529 U.S. 861 INS v. Nat'l Center for Immigrant's Rights, Inc. 502 U.S. 183 Mason v. SmithKline Beecham Corp. 596 F.3d 387 Medtronic v. Lohr 518 U.S. 470 Mills v. Warner-Lambert Co. 581 F. Supp. 2d 772 Robinson v. McNeil Consumer Healthcare 615 F.3d 861 Valdes v. Optimist Club of Suniland, Inc. 27 So. 3d 689 passim Weinberger v. Bentex Pharmaceuticals, Inc. 412 U.S. 645 Wyeth v. Levine 129 S. Ct. 1187 passim Cases: PAGE , (5th Cir. 2010) ....................... 31 , (Cal. 2004) ............23, 24 , (1963) ............................... 22 , (2000) ...............................22, 23 , (1991) ...................................26 , (7th Cir. 2010) ..........................31 , (1966) ....................................7 , (E.D. Tex. 2008) ............... 8, 9 , (7th Cir. 2010) ....................5, 7, 31 , (Fla. 3d DCA 2009) .................. , (1973) ................................9, 28 , (2009) ............................. Federal Statutes 21 U.S.C.§ 301 21 U.S.C. § 332 21 U.S.C. § 333 21 U.S.C. § 334 21 U.S.C.§ 353 21 U.S.C. § 355 21 U.S.C. § 379r 21 U.S.C.§ 393 28 U.S.C. § 1257 Federal Regulations 21 C.F.R. § 201.80 21 C.F.R. § 314.125 21 C.F.R. § 314.70 21 C.F.R. § 330.1 21 C.F.R. § 330.10 passim 21 C.F.R. § 330.5 21 C.F.R. § 341.74 21 C.F.R. § 341.80 passim 21 C.F.R. § 343.50 .................................3, 26 .............................4, 12, 24 .............................4, 12, 24 .............................4, 12, 24 ............................... 3 .............................3, 4, 28 ...................7, 12, 13, 23, 26 ............................... 26 ............................. 1 ........................... 29 .......................... 28 ........................... 5, 29 ...........................4, 8, 11 ............................ ..........................6, 20, 27 ........................... 17 ............................ ........................... 17 57 Fed. Reg. 27658 50 Fed. Reg. 2220 59 Fed. Reg. 43386 41 Fed. Reg. 38312 37 Fed. Reg. 16029 37 Fed. Reg. 9464 Legislative Materials State Rules Miscellaneous OTC Facts Figures Drug Applications for Over-the- Counter Drugs Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products for Over-the- Counter Human Use; Proposed Amendment of Tentative Final Monograph for Over-the-Counter Nasal Decongestant Drug Products, (1992) ..................... 16 Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products for Over-the- Counter Human Use; Tentative Final Monograph for Over-the-Counter Nasal Decongestant Drug Products, (1985) ..................... 15 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over- the-Counter Human Use; Final Monograph for OTC Nasal Decongestant Drug Products ("Final Monograph"), (1994) .................15, 16, 22 Establishment of a Monograph for OTC Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products, (1976) ................... 15 Over-The-Counter Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products, (1972) .................... 15, 27 Procedures for Classification of Over-the- Counter Drugs, (1972) ................... 14, 27 S. Rep. No. 105-43 (1997) ...................13, 14, 26 Fla. R. App. P. 9.030 ......................... 21 Consumer Healthcare Products Association, (The Nielsen Company, 2009), http://www.chpa-info.org/pressroom/ OTC_FactsFigures.aspx ....................... 6 Drug InfoNet, Pharmaceutical Manufacturer Information, Over the Counter/Consumer Drug Manufacturers (visited Oct. 22, 2010), http://www.druginfonet.com/ manufacturers.htm ........................... 6 FDA, (last updated April 26, 2010), http://www.fda.gov/Drugs/Development ApprovalProcess/HowDrugsareDeveloped andApproved/ApprovalApplications/ Over-the-CounterDrugs/default.htm ........... 5 State of Indiana, Criminal Justice Institute, Pseudoephedrine Product List (visited Oct. 21, 2010), http://www.in.gov/cji/files/Product_ List.pdf .................................... 6OPINIONS BELOW
The decision of the Third District Court of Appeal of Florida is reported at 27 So. 3d 689 (Fla. 3d DCA 2009) and reprinted in the Appendix ("App.") at la-5a. The trial court's decision granting Petitioner's Motion for Final Summary Judgment is reprinted at App. 10a-13a.
JURISDICTION
The Third District Court of Appeal issued Valdes v. Optimist Club of Suniland, Inc., 27 So. 3d 689 (Fla. 3d DCA 2009), on December 30, 2009, App. la-5a, and denied a motion for rehearing on February 23, 2010, App. 6a. The Supreme Court of Florida denied McNeil-P.P.C's Petition for Discretionary Review on August 2, 2010, App. 8a. On October 22, 2010, Justice Thomas granted an extension until December 1, 2010 for the filing of this Petition.
This Court has jurisdiction pursuant to 28 U.S.C. § 1257(a).
PERTINENT CONSTITUTIONAL, STATUTORY, AND REGULATORY PROVISIONS
The pertinent constitutional, statutory and regulatory provisions are set forth in the Appendix, 52a-100a.
INTRODUCTION
In Valdes v. Optimist Club of Suniland, 27 So. 3d 689 (Fla. 3d DCA 2009), Florida's Third
District Court of Appeal held that state law failure to warn claims against the manufacturer of an over-the-counter ("OTC") drug product were not pre-empted by federal law set forth in a federal regulation known as a Final Monograph, which requires the manufacturer to use the warnings authored by the Food and Drug Administration ("FDA"). The Florida appellate court determined that it was constrained by Wyeth v. Levine, 129 S. Ct. 1187 (2009), in which this Court rejected Wyeth's broad claim that state-law failure-to-warn claims against it were categorically pre-empted by FDA approval of the warnings for its prescription product, Phenergan. Among other things, this Court rejected a claim of implied conflict pre-emption based on Wyeth's assertion that it was impossible to strengthen its product warnings without prior approval of the FDA.
In rejecting Wyeth's implied conflict pre-emption argument, this Court relied on specific statutes and regulations applicable to manufacturers of brand-name prescription drugs, which allow the manufacturer to strengthen product warnings without prior FDA approval, pursuant to a "changes being effected" ("CBE") procedure. The appellate court in Valdes ignored the fact that prescription and OTC drugs are subject to different federal regulatory regimes. The appellate court failed to recognize that federal laws applicable to manufacturers of OTC products do not provide a mechanism similar to the CBE procedure that would permit a manufacturer to unilaterally change the warnings on product labeling crafted by the FDA. Because the Valdes court did not appreciate this crucial distinction, the court erred in concluding that state-law failure-to-warn claims were not pre-empted by specific federal regulations that apply to OTC product manufacturers.
The Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. (the "FDCA"), and its implementing regulations, provide distinct regulatory regimes for different drug products such as brand-name prescription drugs, generic prescription drugs, and over-the-counter (or nonprescription) drugs. Each regulatory scheme presents a unique set of laws, unique Congressional purposes, and a unique set of mechanisms that affect the safety, cost and efficacy of drugs in our public health system.
For purposes of the FDCA, a prescription drug includes any drug that "because of its toxicity or other potentiality for harmful effect . . . is not safe for use except under the supervision of a practitioner licensed by law to administer such a drug." 21 U.S.C. § 353 (b)(1)(A). Prescription drugs fall into two broad categories for regulatory purposes: brand-name and generic. A manufacturer seeking to market a new brand-name prescription drug must submit a new drug application ("NDA") to the FDA for approval. The NDA must include scientific information, a list of the drug's components, and samples of the proposed labeling for the drug. 21 U.S.C. § 355 (b)(1). The FDA will approve the NDA if it determines the drug is "safe for use." 21 U.S.C. § 355 (d)(1) and (5).
After approval of an NDA, any manufacturer may request approval for a generic version by submitting an abbreviated new drug application ("ANDA"). 21 U.S.C. § 355(j). Rather than submitting independent evidence of safety and efficacy, the manufacturer must show that the generic drug has the same listed ingredients as the "reference listed drug" (the brand-name drug) and that the "labeling proposed for the [generic] drug is the same as the labeling approved for" the brand-name drug. 21 U.S.C. § 355(j)(2)(A) (ii), (iv) and (v).
OTC drugs are drugs that do not meet the statutory definition of "prescription" drugs and, thus, do not require a physician's supervision for their use by a consumer. OTC drugs that have not previously been approved by the FDA pursuant to the NDA or ANDA process can be marketed without prior approval of the FDA if they comply with regulations applicable to categories of products and set forth in an FDA Final Monograph. 21 C.F.R. § 330.1. Broad categories of OTC products for which Final Monographs exist include antacids, contraceptives, and cold and cough remedies.
Under the Final Monograph system, no manufacturer may sell an OTC drug unless its label strictly complies with categorical, mandatory labeling language, which is written by the FDA after formal notice-and-comment rulemaking and codified into law as a Final Monograph. See 21 U.S.C. § 332 (injunction proceedings), 333 (penalties), 334 (seizure); 21 C.F.R. § 330.10(b) (subjecting "[a]ny product which fails to conform to an applicable monograph" to regulatory action). This process differs significantly from the NDA system, under which the manufacturer — not the FDA — is responsible for the contents of the label on its prescription drug. Further, under the NDA process, the manufacturer — not the FDA — must ensure that its warnings remain adequate throughout the marketing life of the drug, and the manufacturer has the ability — through "changes being effected" (CBE) regulations, which do not exist for OTC products — to change its drug label to "add or strengthen" warnings or instructions to increase the safe use of its drug without first obtaining FDA approval. 21 C.F.R. § 314.70(c)(6)(iii)(A), (C).
This Court's decision in Wyeth has been applied in some cases by lower courts to regulatory regimes outside the context of brand-name prescription drugs. Within a matter of months after the Florida court's decision in Valdes, the Seventh Circuit Court of Appeals cited Wyeth for the proposition that courts are free to hold "that state law requires warnings on the label of an over-the-counter drug beyond what the FDA has required." Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 869 (7th Cir. 2010). These courts have misapplied Wyeth by giving it an overly broad application. These decisions would allow state court juries to override the federal Final Monograph regulatory regime put into place by the FDA for OTC products, which has no relationship to the NDA process governing prescription drugs.
The confusion created by the overly-broad application of Wyeth outside the context of brand-name prescription drugs has placed the entire OTC drug industry at risk in the United States. This issue affects more than "300,000 marketed OTC drug products . . . and the labeling of over 80 therapeutic classes of drugs" classified into 26 Final Monograph categories and marketed by at least 26 manufacturers in an annual market that exceeds $16 billion. The OTC drugs at issue in this case, Tylenol Cold and Tylenol Flu, are only two of over 700 products on the market governed by a single FDA OTC Final Monograph for nasal decongestants containing the active ingredients pseudoephedrine and ephedrine.
See FDA, Drug Applications for Over-the-Counter Drugs (last updated April 26, 2010) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ How-DrugsareDevelopedandApproved/ApprovalApplications/ Over-the-CounterDrugs/default.htm, App. 137a-140a.
See 21 C.F.R. § 330.5.
See Drug InfoNet, Pharmaceutical Manufacturer Information, Over the Counter/Consumer Drug Manufacturers (visited Oct. 22, 2010)http://www.druginfonet.com/manufacturers.htm, App. 132a-136a.
See Consumer Healthcare Products Association, OTC Facts Figures (The Nielsen Company, 2009)http://www.chpa-info.org/pressroom/OTC_FactsFigures.aspx, App. 130a-131a.
See State of Indiana, Criminal Justice Institute, Pseudoephedrine and Ephedrine Product List (visited Oct. 21, 2010) http://www.in.gov/cji/files/Product_List.pdf, App. 141a-169a.
Granting this petition would enable the Court to resolve the overbroad and conflicting misapplication of Wyeth to a regulatory regime in which the intent of Congress and the goal of the FDA was to develop across-the-board drug labeling containing a specific set of cautions and instructions applying to categories of drugs in a process designed to permit relatively easy access to the OTC market and ensure low-cost, prescription-free consumer access to safe, time-tested, and properly-labeled medicines. This is in contrast to the NDA process, which applies only to individual prescription drugs, each of whose warnings are developed by the manufacturer and approved by the FDA.
Both Congress and the FDA have recognized that uniformity is essential to ensure safety in the OTC drug market. Congress's stated purpose in amending the Federal Food, Drug, and Cosmetic Act in 1997 was to ensure "national uniformity" in the laws governing nonprescription drug products. 21 U.S.C. § 379r. But the Florida court in Valdes and the Seventh Circuit in Robinson did not address Congressional purpose regarding OTC drugs. Recognition of the distinct Congressional purposes with regard to OTC drugs is essential in considering whether pre-emption applies. Medtronic v. Lohr, 518 U.S. 470, 485 (1966). Overbroad misapplication of Wyeth to the OTC Final Monograph regulatory regime defeats the fundamental Congressional purpose of national uniformity, renders compliance by OTC manufacturers with federal regulations impossible, and threatens to eviscerate the concept of federal pre-emption in all drug cases, regardless of statutory regime or Congressional intent.
In Wyeth, this Court commented that "we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law." 129 S. Ct. at 1203. In a concurring opinion, Justice Breyer emphasized that comment. Justice Breyer noted it is "possible that state tort law will sometimes interfere with the FDA's desire to create a drug label containing a specific set of cautions and instructions" and "it is possible that such determinations would have pre-emptive effect." 129 S. Ct. at 1204 (Breyer, J., concurring). The OTC Final Monograph at issue here is "a specific agency regulation bearing the force of law," and it contains "a specific set of cautions and instructions" authored by the FDA. See 21 C.F.R. § 341.80 ("Labeling of nasal decongestant products").
Granting McNeil's Petition would give this Court the opportunity to rule on a significant preemption issue specifically left open by Wyeth. The Court would be able to clarify the pre-emptive effect of FDA regulations bearing the force of law that require OTC products to use a specific set of warnings in order to be considered "safe" and "not misbranded." 21 C.F.R. § 330.1. At the same time, this Court could clarify the confusion stemming from overbroad application of Wyeth by lower courts.
STATEMENT OF THE CASE
A. Factual Background 1. FDA Regulatory Regime for OTC Drugs.
The Federal Food, Drug and Cosmetic Act ("FDCA") together with implementing regulations of the Food and Drug Administration ("FDA"), provide a comprehensive scheme of drug regulation. Since its enactment in 1938, the FDCA has been amended on a number of occasions. Amendments enacted in 1962 added requirements that drugs must be not just safe, but effective as well, and that the labeling of a drug cannot be false or misleading. See Mills v. Warner-Lambert Co., 581 F. Supp. 2d 772, 783 (E.D. Tex. 2008). The 1962 amendments required the FDA to examine all marketed drugs for their effectiveness, whether or not they had been approved previously.
The FDA recognized that it could not possibly evaluate each of the prescription and OTC drugs already on the market without assistance. Id.; see Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 650 (1973) (recognizing that in 1973 there were between 100,000 and 500,000 OTC drugs on the market, most of which had not been previously approved by the FDA). Accordingly, the FDA enlisted the National Academy of Sciences — National Research Council to create panels of experts to evaluate categories of OTC drugs. Mills, 581 F. Supp. 2d at 783. The Academy established seventeen advisory panels of outside experts to review twenty-six categories of OTC drugs, which were grouped by their intended effect ( i.e. antacids, cold remedies). This approach was deemed prudent because although there are hundreds of thousands of OTC products, the drugs contain a relatively small number of active ingredients. Id. at 784.
The purpose of the review of OTC products was to ensure that the products were safe and not misbranded. This is known as the "monograph process." Id. The detailed four-step procedure for classifying OTC drugs as "generally recognized among qualified experts as safe and effective for use and not misbranded" is set forth in 21 C.F.R. § 330.10. In the first step, the FDA Commissioner appoints an advisory review panel of qualified, independent experts for each designated OTC drug category to evaluate the safety and effectiveness of OTC drugs, to review OTC drug labeling, and to advise on the promulgation of monographs. 21 C.F.R. § 330.10(a)(1). The panel then reports its conclusions and recommendations to the FDA "with respect to the safety and effectiveness of the drugs" in the designated OTC category. Id.
As the Mills court noted, a "monograph" is defined by Webster's Third New International Dictionary (1986) as "a learned detailed thoroughly documented treatise covering exhaustively a small area of a field of learning." Mills, 581 F. Supp. 2d at 784, n. 9.
In the second step, the FDA reviews the expert panel's findings and then publishes a notice in the Federal Register requesting interested persons to submit for review and evaluation by the advisory panel "published and unpublished data and information pertinent to a designated category of OTC drugs." Id. at (a)(2). The advisory panel meets "as often and for as long as is appropriate" to review the data submitted to it and to prepare a report "with respect to the safety and effectiveness of the drugs in a designated category of OTC drugs." Id. at (a)(3). The panel may consult any individual or group; interested persons may request permission to present oral views to the panel. Id.
After the FDA Commissioner reviews the expert panel's conclusions and recommendations, the Commissioner is required to publish in the Federal Register a proposed order containing, among other things, a monograph establishing conditions under which a category of OTC drugs is "generally recognized as safe and effective and not misbranded." 21 C.F.R. § 330.10(a)(6)(i). The publication must contain the full report of the panel, and interested persons are allowed to file comments and documents. Id. at (a)(6)(iv). After reviewing all comments and any new data and information, the Commissioner is required to publish in the Federal Register a tentative order containing a monograph establishing conditions under which a category of OTC drugs is "generally recognized as safe and effective and not misbranded." 21 C.F.R. § 330.10(a)(7)(i). Again, interested persons are permitted to file written comments or objections. Id. The FDA then considers any comments regarding the monograph and conducts an oral hearing if there are "reasonable grounds" for doing so. 21 C.F.R. § 330.10(a)(8).
In the fourth and final phase, the FDA, "[a]fter reviewing [any] objections, the entire administrative record including all new data and information and comments, and considering the arguments at any oral hearing," publishes in the Federal Register "a final order containing a monograph establishing conditions under which a category of OTC drugs . . . is generally recognized as safe and effective and not misbranded." 21 C.F.R. § 330.10(a)(9).
The Final Monograph for a class of OTC drugs includes labeling requirements. The manufacturer of an OTC product must use the exact warning language authored by the FDA. The Code of Federal Regulations provides that " labeling under this subchapter and subchapter C et seq. of this chapter shall be stated in the exact language where exact language has been established and identified by quotation marks in an applicable OTC drug monograph or by regulation [.]" 21 C.F.R. § 330.1(c)(2) (emphasis added). The FDA's labeling requirements are designed to provide warnings reflecting known risks based on reliable scientific evidence. See generally 21 C.F.R. § 330.10(a) (procedure for establishing OTC monograph); § 341.80 (labeling of nasal decongestant drug products). Adequate warnings are those that, in the judgment of the FDA, are "clear and truthful in all respects, not misleading in any particular," and that accurately communicate the benefit to risk ratio and the proper use of the product in terms "likely to be read and understood by the ordinary individual." 21 C.F.R. § 330.10(a)(4)(v).
Compliance with the Final Monograph by the OTC drug manufacturer is mandatory. "Any product which fails to conform to an applicable monograph after its effective date is liable to regulatory action." 21 C.F.R. § 330.10(b). Therefore, once a Final Monograph goes into effect, it is illegal to sell a drug described therein unless it conforms to the monograph. See generally 21 U.S.C. §§ 332- 334. If a drug is marketed without prior FDA approval or without complying with an applicable monograph, the United States may bring an enforcement action under the FDCA. Id. Enforcement measures include seizure of the drug product, civil injunction against its sale and criminal penalties against the violator. Id.
Another significant amendment to the FDCA, as pertinent to OTC products, was the 1997 Food and Drug Modernization Act ("Modernization Act") which expressly states Congress's fundamental purpose of national uniformity in the regulation and labeling of nonprescription drugs. 21 U.S.C. § 379r. Section 379r, entitled "National Uniformity for Nonprescription Drugs," provides in relevant part:
(a) In general
Except as provided in subsection (b), (c)(1), (d), (e), or (f) of this section, no State or political subdivision of a State may establish or continue in effect any requirement
* * *
(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter . . . .
Id. (emphasis added).
As demonstrated by the legislative history of the Modernization Act, "[d]ifferent or additional requirements at the State or local level can work against our national marketplace, confuse consumers, raise prices, undermine public confidence in our regulatory system and in products important to public health, and result in divergent public health protection throughout the country." S. Rep. No. 105-43, at 64 (1997), App. 101a-127a. Accordingly, Congress specifically expressed its intent to achieve national uniformity in connection with OTC drug labeling:
Section 808 of the legislation therefore established a new section 761 of the Federal Food, Drug, and Cosmetic Act that adopts, as a general rule, the requirement of national uniformity in the regulation of nonprescription drugs and cosmetics and their constituents. No State or local government is permitted to impose different or additional requirements that relate to the subject matter covered by the three Federal laws as they apply to nonprescription drugs and cosmetics. These include requirements imposed on product manufacture or composition, labeling, advertising, or any other form of public notification or communication.
Id.
The Modernization Act also reinforces the well-recognized role of the FDA with regard to non-prescription drugs:
Nonprescription drugs are subject to careful and comprehensive regulation by the FDA. The conditions under which nonprescription drugs are considered safe and effective, for use by the lay consumer, are specified by the FDA in nonprescription drug monographs or by new drug and antibiotic drug applications. The FDA also ensures that the labeling of nonprescription drugs provides adequate directions for use, and adequate warnings against unsafe use, through these monographs and drug marketing applications, as well as through a number of general and specific labeling regulations.
Id. 2. FDA's Final Monograph Regulation of OTC Nasal Decongestants
The 1994 approval of the Final Monograph for OTC nasal decongestants (including those containing pseudoephedrine products) was the result of a 22-year-long process. The process began in 1972, when the FDA Commissioner signed the final regulations providing for OTC drug review and published in the Federal Register a specific request for data and information on all cold, cough, allergy, bronchodilator and antiasthmatic (CCABA) active ingredients. A notice of a proposed monograph was published in the Federal Register on September 9, 1976. The proposed monograph was the result of the evaluation of data by the Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products.
Procedures for Classification of Over-the-Counter Drugs, 37 Fed. Reg. 9464 (1972); Over-The-Counter Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products, 37 Fed. Reg. 16029 (1972) .
Establishment of a Monograph for OTC Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products, 41 Fed. Reg. 38312 (1976).
See Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for OTC Nasal Decongestant Drug Products ("Final Monograph"), 59 Fed. Reg. 43386 (1994).
After review and evaluation of comments submitted, the advisory panel issued a tentative Final Monograph for OTC nasal decongestant products on January 15, 1985, which was published in the Federal Register. Interested persons were invited to file written comments, objections, or requests for oral hearing before the Commissioner of the FDA regarding the proposed monograph.
Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products for Over-the-Counter Human Use; Tentative Final Monograph for Over-the-Counter Nasal Decongestant Drug Products, 50 Fed. Reg. 2220 (1985).
At all times during the process, the FDA and the expert advisory panel considered any data relevant to the tentative Final Monograph and published corrections or changes to the monograph based upon the safety and effectiveness of the products subject to the monograph. For example, in 1992, the FDA published a notice to amend the tentative Final Monograph for OTC nasal decongestant drug products to modify the drug interaction precaution statement to warn against taking such products if a consumer was also taking a prescription drug containing a monoamine oxidase inhibitor (MAOI) without first consulting a physician.
Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products for Over-the-Counter Human Use; Proposed Amendment of Tentative Final Monograph for Over-the-Counter Nasal Decongestant Drug Products, 57 Fed. Reg. 27658 (1992).
On August 23, 1994, the FDA issued its Final Monograph establishing the conditions under which OTC nasal decongestant products are generally recognized as safe and effective and not misbranded. See Final Monograph, 59 Fed. Reg. 43386 (codified at 21 C.F.R. pt. 341). This Final Monograph included precise labeling requirements (including warnings) for OTC nasal decongestants containing pseudoephedrine (and other active ingredients). 21 C.F.R. § 341.80.
3. The Operative FDA Warning Label
The FDA-authored mandatory warnings for OTC nasal decongestants containing pseudoephedrine are set forth in 21 C.F.R. § 341.80(c), App. 54a-68a. The labels on McNeil's Tylenol Cold and Tylenol Flu use the language required by the regulation, App. 128a-129a.
Tylenol Cold and Tylenol Flu are both multisymptom products containing permitted combinations of active ingredients in addition to pseudoephedrine. McNeil's product labeling sets forth warnings required for those other active ingredients, such as acetaminophen (for pain and fever) and dextromethorphan hydrobromide (a cough suppressant and antitussive). See, e.g., 21 C.F.R. § 341.74(c)(1) (the regulation containing the Final Monograph for antitussive drug products). It is undisputed that McNeil's labeling fully complied with all applicable federal regulations.
Pursuant to other FDA regulations and guidelines, one of these warnings, set forth in 21 C.F.R. § 341.80(c)(1)(i)(B) ("If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor."), is slightly modified to take into account the required warning for acetaminophen. The warning for acetaminophen containing products must state "Do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor." 21 C.F.R. § 343.50(c)(1). As required by the FDA, these warnings were consolidated in the most restrictive manner and are set forth in the subject label as "Do not take for pain for more than 7 days or for fever for more than 3 days unless directed by a doctor."
B. Proceedings Below
1. The Trial Court Proceedings
While playing roller hockey, 16-year-old Armando Valdes allegedly suffered heatstroke and cardiorespiratory arrest. Respondents brought alternative state law liability claims against Defendants Optimist Club of Suniland, Optimist International, the Sports Authority, Inc., JOFA AB, KHF Sports OY, The Hockey Company, and McNeil — P.P.C. Respondents based their claim against McNeil solely upon an alleged failure to warn. Respondents alleged that Armando Valdes took either Tylenol Cold or Tylenol Flu, and had at least one caffeinated beverage prior to playing roller hockey. According to the Respondents, Tylenol Cold and/or Tylenol Flu, which contains pseudoephedrine, "increased the risk of heat-related illness and heart-related risks when ingested with caffeinated products and coupled with strenuous or athletic events in a hot environment like that of South Florida." Valdes, 27 So. 3d at 690. Respondents alleged that McNeil's "failure to warn of these risks on the labels of the Tylenol Cold/Flu packaging breached Florida state law requirements." Id. McNeil asserted its affirmative defenses, including federal pre-emption.
Respondents alleged that the Optimist Club defendants acted negligently when they allowed Armando to play hockey in extreme heat and without safe protocols; that the Sports Authority was negligent for selling improper equipment without sufficient ventilation for roller hockey; and that JOFA, KHF and The Hockey Company, the manufacturers of the helmet and gloves used by Armando, were negligent and strictly liable for having sold products that were defective, App. 17a-51a.
The trial court granted McNeil's motion for final summary judgment on federal pre-emption grounds. Among other things, the trial court specifically found that implied conflict pre-emption applied because it would have been impossible for McNeil to comply with federal regulations that mandate the exact warnings for labels of all OTC pseudoephedrine-containing products (including those sold by McNeil) while also meeting state common law jury determinations of whether the FDA-crafted warnings were adequate. The trial court also concluded that permitting Florida to enforce a common law duty to warn would defeat the fundamental federal objective of national uniformity in the labeling of OTC Final Monograph drugs, App. 10a-13a. The trial court entered judgment in accordance with its ruling, App. 14a-16a.
2. The Appeal to the Third District Court of Appeal of Florida
Respondents appealed to the Third District Court of Appeal of Florida. After their initial brief was filed, this Court issued its decision in Wyeth v. Levine, which rejected a brand-name prescription drug manufacturer's argument that FDA approval of its product's warnings pre-empted state law failure to warn claims. This Court found that it was not impossible for Wyeth to strengthen its product warnings because Wyeth could take advantage of a "changes being effected" provision, applicable to prescription drugs approved under the NDA procedure, and change its labeling without first seeking FDA approval. This Court also concluded that imposing liability on Wyeth for the alleged inadequacy of its warning would not stand as an obstacle to the accomplishment of federal regulatory requirements and purposes. Wyeth, 129 S. Ct. at 1204.
Florida's appellate court reversed the final summary judgment for McNeil, finding that "the facts in Wyeth are similar to the ones here, and the arguments made by the prescription drug manufacturer are practically identical to those advanced by McNeil." Valdes, App. 4a. The Florida court addressed no case other than Wyeth, and the federal regulations applicable to McNeil's products were not cited in the opinion.
The appellate court did not address McNeil's argument that Wyeth involved an entirely distinguishable regulatory regime. Regulations governing an NDA allow the manufacturer to change its warning without prior approval from the FDA. Conversely, the OTC Final Monograph regulations do not contain a "changes being effected" (CBE) provision. Rather, all manufacturers of OTC nasal decongestant products containing pseudoephedrine are required to use the identical labeling language set forth in the Final Monograph codified into law. See 21 C.F.R. § 330.10(b).
The appellate court did not address McNeil's claim that principles of implied pre-emption applied because it was impossible for McNeil to comply with the applicable Final Monograph as well as state law, which, according to the Respondents, would require additional warnings that did not conform to the monograph. In addition, the appellate court failed to address McNeil's argument that permitting Florida to enforce its traditional common law duty to warn would stand as an obstacle to the accomplishment of the fundamental Congressional objective of national uniformity in the labeling of nonprescription drugs.
The appellate court failed to recognize how its decision would impact the actions of the other OTC product manufacturers using the identical FDA warnings on their pseudoephedrine products. Nor did it address how the decision would affect the conduct of manufacturers of OTC Final Monograph products in other categories of drugs. All manufacturers of OTC Final Monograph drugs are required to use the identical FDA-crafted warnings as codified in the Final Monographs governing over 26 OTC drug categories. See 21 C.F.R. § 330.5.
The appellate court never contemplated whether its ruling would require every manufacturer to acquire an equivalent knowledge base which would need to be continually updated, or whether the cost of doing so would be reflected in the prices of the OTC drugs approved by the Final Monograph process. Such a requirement would surely diminish the ability of manufacturers of Final Monograph OTC drugs to continue to sell their products pursuant to the mandatory provisions of the monograph, as Congress intended.
3. The Appeal to the Supreme Court of Florida
On March 26, 2010, McNeil sought discretionary review by the Supreme Court of Florida because the Third District's decision had the effect of construing the Supremacy Clause of the United States Constitution. See Fla. R. App. P. 9.030(a)(2)(A)(ii) (providing for discretionary jurisdiction to review decisions of district courts of appeal that construe a provision of the state or federal constitution). On August 2, 1010, the Supreme Court of Florida denied McNeil's Petition for Discretionary Review, App. 8a.
REASONS FOR GRANTING THE PETITION
I. The Court Should Grant Review to Correct Florida's Rejection of Impossibility Conflict Pre-emption in a Case Where, Unlike the NDA Regulatory Scheme, the OTC Final Monograph Regulatory Regime Does Not Contain a Provision that Would Allow a Product Manufacturer to Unilaterally Change its Product Labeling by Adding Warnings that Were Not Approved by the FDA.
The doctrine of conflict pre-emption is triggered when compliance with both state and federal law is impossible because one requires what the other prohibits. Florida Avocado Growers v. Pault, 373 U.S. 132, 142-143 (1963). In other words, "a case of impossibility" conflict pre-emption is one in which "state law penalizes what federal law requires." Geier v. American Honda Motor Co., 529 U.S. 861, 873 (2000). Here, federal law requiring McNeil's product labeling to use the exact warnings set forth in a Final Monograph irreconcilably conflicts with state law that, according to Respondents, would require McNeil to unilaterally provide additional warnings.
The FDA's Final Monograph establishing the conditions under which nasal decongestants containing pseudoephedrine are generally recognized as "safe and effective and not misbranded" is published at 59 Fed. Reg. 43386 and the warning label requirements are set forth in 21 C.F.R. § 341.80(c)(1). The federal regulation established by the FDA sets forth the mandatory labeling requirement for all manufacturers of all products encompassed by the Final Monograph, App. 54a-68a. It is undisputed that McNeil complied. The additional warnings proposed by Respondents are illegal because they are not in compliance with the mandatory labeling language codified in section 341.80(c).
Moreover, the additional warnings urged by Respondents are "different from, in addition to and are not otherwise identical to" those set forth in the applicable Final Monograph. 21 U.S.C. § 379r (providing for national uniformity for non-prescription drugs). In Wyeth, the Court noted that product liability actions against an OTC manufacturer are not expressly pre-empted by section 379r, due to the savings clause contained in section 379r(e). See Wyeth, 129 S. Ct. at 1200 n. 8. That does not, however, foreclose application of the doctrine of implied conflict pre-emption. See Geier, 529 U.S. at 896-97 (recognizing that an express pre-emption provision coupled with a savings clause does not bar the ordinary working of conflict pre-emption principles).
This point was made in Dowhal v. SmithKline Beecham Consumer Healthcare, 88 P.3d 1 (Cal. 2004). In Dowhal, a citizen filed an action against various drug companies to challenge their failure to place health warnings mandated by California's Proposition 65 on nicotine replacement therapy (NRT) products. In enacting section 379r, Congress included a specific savings clause to preserve Proposition 65 from the express pre-emptive effect of the statute. See 21 U.S.C. § 379r(d)(2) ("This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997"). The savings clause was designed to preserve Proposition 65, the only state enactment that fell within its terms. See Dowhal, 88 P.3d at 4.
The California Supreme Court held that although the section 379r savings clause precluded express pre-emption of Proposition 65, it did not preclude application of implied conflict pre-emption. Id. at 9. "The language of the Modernization Act's savings clause does not express an intention to preclude all conflict pre-emption." Id. The court recognized that principles of conflict pre-emption would apply if there was a direct conflict between state and federal law or if the state law stood as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Id. at 11.
In this case, the Florida court read Wyeth so broadly as to preclude the assertion of implied conflict pre-emption based on impossibility under any circumstances. This case presents a classic example of impossibility. Federal regulations provide for specific warnings and further provide that "any product which fails to conform to an applicable monograph after its effective date is liable to regulatory action." Once a monograph goes into effect, it is illegal to sell a drug described therein unless it conforms to the monograph. See also 21 C.F.R. § 330.10(a)(9), 21 U.S.C. §§ 332- 334 (providing remedies and penalties for failure to conform). If an OTC product does not comply with a controlling Final Monograph, the United States may bring an enforcement action under FDCA. See id. Therefore, it is impossible for McNeil to comply with federal law and also provide the additional warnings the Respondents are now asking a state court jury in Florida to impose.
In Wyeth this Court specifically held that impossibility pre-emption was not available to Wyeth because "the CBE regulation permitted Wyeth to unilaterally strengthen its warning and the mere fact that the FDA approved Phenergan's label does not establish that it would have prohibited such a change." 129 S. Ct. at 1199. Here, by contrast, neither Congress nor the FDA allowed a manufacturer of an OTC product to unilaterally change product warnings that are required to appear verbatim on labeling provided by a manufacturer of a specific category of OTC Final Monograph products.
Without pre-emption, OTC drug manufacturers would be deprived of the ability to rely on FDA's directives as to matters that Congress delegated to the Agency and that fall within the Agency's unique regulatory and scientific expertise. Without pre-emption, McNeil, and all other OTC drug manufacturers, would be deprived of the ability to comply simultaneously with their federal and state obligations or even to ascertain what those obligations are without resort to litigation.
II. The Court Should Grant Review to Resolve the Issue of Whether State Failure-to-Warn Claims Against OTC Final Monograph Drug Manufacturers Stand as an Obstacle to National Uniformity.
This Court has held that "the purpose of Congress is the ultimate touchstone in every preemption case." Wyeth, 129 S. Ct. at 1187. The historical purpose of the Federal Food, Drug Cosmetic Act ("FDCA") was to establish a comprehensive scheme of drug regulation to ensure that drugs are safe and effective for their intended use. See 21 U.S.C. § 301 et seq. The FDA was established as the sole federal agency commissioned both to "protect the public health" by ensuring that drugs are safe and effective and to "promote the public health" by ensuring prompt public access to drugs it has found to be safe and effective. 21 U.S.C. § 393(b). The mechanisms Congress put in place to accomplish the goals of safety and efficacy for nonprescription drugs further illustrate how Congress went about achieving national uniformity.
The FDA Modernization Act of 1997 is codified at 21 U.S.C. section 379r, entitled "National Uniformity for Nonprescription Drugs." The title of the section leaves no doubt that Congress sought uniformity in the regulation of nonprescription drugs. See, e.g., INS v. Nat'l Center for Immigrant's Rights, Inc., 502 U.S. 183, 189 (1991) (a section's title can aid in its interpretation).
The legislative history of the Modernization Act further demonstrates Congress's fundamental purpose of achieving national uniformity by recognizing that "[d]ifferent or additional requirements at the state or local level can work against our national marketplace, confuse consumers, raise prices, undermine confidence in our regulatory system and in products important to public health and result in different public health protection throughout the country." S. Rep. No. 105-43, at 64 (1997).
The goal of national uniformity is apparent from the various statutes and implementing regulations that govern the categories of OTC products, which must have identical labeling regardless of manufacturer. Unlike the NDA regulatory scheme, which focuses on a single drug by a single manufacturer, the Final Monograph regime provides for grouping OTC medications by class or therapeutic category. See 21 C.F.R § 330.5 (OTC drug categories). The FDA studies and approves the category or class of drug, rather than a specific brand or a single drug, as with an NDA. The FDA recognized that hundreds of thousands of OTC products were on the market and would continue to be marketed. Thus, the FDA determined that OTC products using the same active ingredient(s) should have the same labeling requirements.
The regulations that apply to OTC products stand in stark contrast to the regulations applicable to brand-name drugs. First, the NDA process begins when a single manufacturer submits its application for approval to the FDA for its unique drug. Conversely, the Final Monograph process begins with notice-and-comment rulemaking. Here, the FDA Commissioner published a request in the Federal Register seeking data and information on all cold, cough, allergy, bronchodilator and antiasthmatic active ingredients. Procedures for Classification of Over-the-Counter Drugs, 37 Fed. Reg. 9464 (1972); Oyer-the-Counter Cold, Allergy, Bronchodilator and Antiasthmatic Drug Products, 37 Fed. Reg. 16029.
Second, under the NDA regime, the manufacturer of a single unique product has the burden of proving that its drug is "safe for use under the conditions prescribed, recommended or suggested in the proposed labeling before it may distribute the drug." 21 U.S.C. § 355; 21 C.F.R. § 314.125. By contrast, the OTC Final Monograph regime does not place this burden on the manufacturers. The FDA appoints an advisory review panel of qualified experts to evaluate the safety and effectiveness of a "designated category of drugs." 21 C.F.R. § 330.10(a)(1); see also Weinberger, 412 U.S. at 650. The panel then investigates the drug category, "reviews all available data" and reports its "conclusions and recommendations to the FDA" with respect to the safety and effectiveness of the drugs in the category. 21 C.F.R. § 330.10(a)(3).
Third, under the NDA regime the manufacturer of a single unique product has the burden of providing substantial evidence that its drug will have the effect it is represented to have under the conditions of use prescribed, recommended or suggested in the manufacturer's proposed labeling. See 21 U.S.C. § 355; 21 C.F.R. § 314.125. By contrast, manufacturers of OTC Final Monograph drugs are not required to introduce evidence proving safety, effectiveness, or conditions of use. Manufacturers of OTC Final Monograph drugs are not required to test, study, investigate or participate in the regulatory process. The only requirement placed on manufacturers of an FDA OTC Final Monograph product is to follow the Final Monograph.
The OTC Final Monograph regime charges the FDA with preparing a proposed monograph "prescribing drug composition, labeling, and manufacturing controls," publishing it in the Federal Register for comments and considering any additional data that is submitted before publishing a tentative Final Monograph in the Federal Register. 21 C.F.R. § 330.10(a)(6), (7). After publication of the tentative Final Monograph, the FDA again considers comments and conducts an oral hearing if there are "reasonable grounds" for doing so. 21 C.F.R. § 330.10(a)(8). Then, "after reviewing [any] objections, the entire administrative record including all new data and information and comments, and considering the arguments made at any oral hearing," the FDA publishes in the Federal Register a Final Monograph "establishing conditions under which a category of OTC drugs is generally recognized as safe and effective and not misbranded." 21 C.F.R. § 330.10(a)(9). In this case, the FDA Final Monograph applicable to Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human use is codified at 21 C.F.R. Part 341.
Fourth, under the NDA regime the manufacturer is specifically charged with drafting an adequate label and ensuring that its warnings remain adequate as long as its drug is on the market. See 21 C.F.R. § 201.80(e). Under this regime, the FDA promulgated a "changes being effected" (CBE) regulation. 21 C.F.R. § 314.70(c)(6)(iii). The CBE regulation provides that if a manufacturer changes its label to "add or strengthen a contraindication, warning, precaution, or adverse reaction" or to "add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product," it may make the labeling change upon filing a supplemental application with the FDA; it need not wait for FDA approval. § 314.70 (c)(6)(iii)(A), (C). The Wyeth Court found that this provision made it possible for an NDA manufacturer to change the warning on its label without violating federal law. Wyeth, 129 S. Ct. at 1196-1199.
The omission of a CBE regulation in the OTC Final Monograph regulatory regime serves national uniformity. No manufacturer is permitted to change the warning because the warning is not "its" warning for "its" unique product. The FDA's codified warnings apply to entire categories of products produced by many different manufacturers. Allowing unilateral changes to the warning language required by a Final Monograph would destroy national uniformity and undermine public safety.
The Wyeth majority specifically recognized that "some state-law claims might well frustrate the achievement of congressional objectives." Id. at 1204. Justice Breyer noted in his concurring opinion that there were circumstances where a plaintiff's inadequate warnings claim under "state tort law" would "interfere with the FDA's desire to create a drug label containing a specific set of cautions and instructions." Id. at 1204 (Breyer, J., concurring). Accordingly, this Court should take the opportunity to clarify whether state-law requirements for additional warnings on OTC products subject to a Final Monograph would stand as an obstacle to accomplishing the goal of national uniformity. III. The Court Should Grant Review to Clarify the Confusion Stemming from Overbroad Applications of Wyeth v. Levine by Lower Courts.
Some lower courts have given an overly-broad application to Wyeth by applying the decision to regulatory schemes other than the NDA process for brand-name drugs. The decisions have used sweeping language stating that the Wyeth decision applies to all OTC drugs. That is what the Florida court did in this case. Another example is the Seventh Circuit's decision in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010). Robinson relied on Wyeth v. Levine for the proposition that a court is not barred "from holding that state law requires warnings on the label of an over-the-counter drug beyond what the FDA has required." Id. at 869.
The Robinson court relied upon decisions involving prescription drugs. See Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7th Cir. 2010) (involving the brand-name drug Paxil for treatment of depression); Demahy v. Actavis, 593 F.3d 428 (5th Cir. 2010) (involving a generic drug used for the treatment of heartburn). The decisions did not involve OTC drugs subject to Final Monographs.
This Court's decision in Wyeth left open the question of pre-emption with regard to drugs, such as the OTC drugs at issue here, which are subject to specific federal labeling regulations. As the Court stated in Wyeth, "we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law." 129 S. Ct. at 1203. By contrast, this case presents just such an occasion. McNeil's products and their labeling had to comply with specific FDA regulations bearing the force of law and mandating the exact language to be used on the products' labeling.
In Wyeth, Justice Breyer concurred to emphasize the Court's statement that "we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law." Id. at 1204 (Breyer, J. concurring). As Justice Breyer recognized, it is "possible that state tort law will sometimes interfere with the FDA's desire to create a drug label containing a specific set of cautions and instructions." Id. That is exactly the situation presented by the conflict between Respondent's state-law failure-to-warn . claims and the Final Monograph regime which required McNeil to place a specific set of cautions and instructions on its product.
Accepting review will allow this Court to answer the important pre-emption question left open by Wyeth by determining whether specific FDA regulations that require OTC drug manufactures to comply with the labeling requirements of Final Monographs pre-empt state law failure-to-warn claims. Accepting review would provide an opportunity for this Court to resolve the confusion created by lower courts that have given an overly-broad application to Wyeth.
CONCLUSION
For the foregoing reasons, this Court should grant the petition for a writ of certiorari.
Respectfully submitted,