# Petition for Writ of Certiorari — Wyeth v. Levine > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0529%3A02 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 2009 - **Citation:** 555 U.S. 555 ## Text ’ a Supreme Court. J i FLED No. 06- 061249 Map 12 9007 hemp OFFICE OF THE CLERK Supreme Court of the United States WYETH, Petitioner, V: DIANA LEVINE, Respondent. On PeviTion FOR A WRIT OF CERTIOKARI TO THE SUPREME COURT OF THE STATE OF VERMONT PETITION FOR A WRIT OF CERTIORARI ALLAN R. KEYES Bert W. REIN R. Josep O'Rourke Counsel of Record RYAN, SmirxH, Carine, LTD. KARYN K. ABLIN 98 Merchants Row Wiittam S. Consovoy P.O. Box 310 Witey Rein LLP Rutland, VT 05702-0310 1776 K Street NW (802) 786-1000 Washington, D.C. 20006 (202) 719-7000 Attorneys for Petitioner A mal ce P t pet (Remap P74 TAIT © (ROOD 189-6854 i QUESTION PRESENTED Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (“FDA”) pursuant to FDA’s comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 ef seg., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. il LIST OF PARTIES Pursuant to Rule 14.1(b), the following list identifies all of the parties to the appellate proceeding in the Supreme Court of Vermont, whose judgment is sought to be reviewed: A. Petitioner Wyeth B. Respondent Diana Levine CORPORATE DISCLOSURE STATEMENT Petitioner Wyeth has no parent corporation, and no publicly held company owns 10% or more of its stock. ill TABLE OF CONTENTS Page QUESTION PRESENTED ..... cece ccscscces 1 Sg ere ore re Tree il CORPORATE DISCLOSURE STATEMENT ..... il pg ss en ee il TABLE OF CITED AUTHORITIES ............ v peo ee Xil oe ok eek eek ee SRO ee l + tcc shed du eee Fone oe os me one | PERTINENT CONSTITUTIONAL, STATUTORY, AND REGULATORY PROVISIONS ......... I EE Wes sis wh dpc uken ¥e bees 9070 l STATEMENT OF THE CARE ...... ccc eeeeeess 3 a og ee ie we axees 3 1. FDA Regulatory Regime ............ 3 2. FDA’s Regulation of Phenergan ...... 6 3. The Operative Phenergan Label when Respondent Was Treated ............ 8 iv Contents Page 4. The Administration of Phenergan to ES cat aay wh at an CoS Ke 9 I re 10 1. The Trial Court Proceedings ......... 10 2. The Appeal to the Vermont Supreme re ene a eres yee eee 10 REASONS FOR GRANTING THE PETITION ... 13 I. The Court Should Grant Review To Correct Vermont’s Rejection of Impossibility Conflict Preemption Stemming from its Mischaracterization of FDA’s Comprehensive Regulatory Regime. Pe ee eee See eo Ce Eee 15 II. The Court Should Grant Review To Clarify the Effect, If Any, of the Presumption Against Preemption and Section 202 of the 1962 FDCA Amendments on the Application of “Obstacle” Conflict Preemption to Prescription Drug ee rare re eee ae ee 2) Ill. The Court Should Grant Review To Resolve the Conflict Concerning the Degree of Deference that Courts Should Accord FDA’s Formal Position on the Extent to Which State Tort Law Labeling Judgments Interfere with PDAS Labetmeg Remene. ........ccsceees 27 SEE so0 6S Cee heehee We et eweee wae 30 TABLE OF CITED AUTHORITIES Page(s) FEDERAL CASES Auer v. Robbins, oo ree ry Teer ce 29 Bates v. Dow Agrosciences LLC, SG Us Ge BN 5 co kets seceseveaveseta 26, 30 In re Bextra & Celebrex Marketing Sales Practices & Product Liability Litigation, No. 05-1699, 2006 WL 2374742 CPOE SA FO FE vet kee tcesccecss 29 Buckman Co. v. Plaintiffs’ Legal Committee, Pe CH POPE 8:05-6:00 A cds Showa CRTs 26 Caraker v. Sandoz Pharmaceuticals Corp., 172 F. Supp. 2d 1018 (S.D. Hl. 2001) .......-. 16,18 Cartwright v. Pfizer, Inc., 369 F. Supp. 2d 876 (E.D. Tex. 2005) ......... 16 Cipollone v. Liggett Group, Inc., MS Perey ee 14, 24 City of Camden v. Beretta U.S.A. Corp., 81 F. Supp. 2d 541 {D.N.J. 2000) ............ 23 Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006) .......... 29 vi Cited Authorities Page(s) Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189 (D.N.D. 2002), aff'd, 367 F.3d 1013 (8th Cir. 2004) ............... 17 Fidelity Federal Savings & Loan Ass'n v. de la Cuesta, cca bavenenseanences 14, 28 Florida Lime & Avocado Growers, Inc. v. Paul, EE 14 Freightliner Corp. v. Myrick, cer k kets ese ee dena 17 Geier v. American Honda Motor Co., deve eke cede ese seeeees passim Heckler v. Chaney, ee Ce wea eeheeuaenea 4 20 Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707 (1985) ....... 28 Hines v. Davidowitz, ee Wed cab dude one enee 14 Horn v. Thoratec Corp., 376 F.36 163 (36 Cir. 2004) ..... 2... ccc eens: 21, 29 International Paper Co. v. Ouellette, Ee 24, 26 Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964 (D. Neb. 2006) .......... 29 vil Cited Authorities Mazur v. Merck & Co.., 742 F. Supp. 239 (E.D. Pa. 1990) ......... McDermott v. Wisconsin, ot So oe Wid va 6 b'0.00 06 be McNellis v. Pfizer, Inc., No. Civ. 05-1286, 2005 WL 3752269 (D.N.J. Dec. 29, 2005), stay granted and motion to certify appeal granted, No. Civ. 05-1286 (JBS), 2006 WL 2819046 (D.N.J. Sept. 29, 2006) See eeeseeeeeegee@eedtceeePgcete@tee@eec@e~esgeeoe@@ete@esses8 @ Medtronic Inc. v. Lohr, i ics; on cnc cck eee ewek Needleman v. Pfizer, Inc., No. 3:03-C V-3073-N, 2004 WL 1773697 Ge Hs CE GR ED nic seve cccccce: Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033 (10th Cir. 2006) .......... Perry v. Novartis Pharma. Corp., 456 F. Supp. 2d 678 (E.D. Pa. 2006) ...... Rice v. Santa Fe Elevator Corp., Ec ccccncsceeestsevns Schering Corp. v. FDA, Fe Cede SOP EPO Ge SOUOD 6 cccccccccnses Foss 22 Cans 16 wake 21 jeen 17 er 20 inne 28 dm 24 doles 20 vill Cited Authorities Schneidewind v. ANR Pipeline Co., SP EE wake Scevcdeccends Sinnot v. Davenport, 63 U.S. (22 How.) 227 (1859) ......... Smith v. United States, Fe rer rs Thomas Jefferson University v. Shalala, FE Ws SPE SOOED 0 0c chr ccccedeces Udall v. Tallman, Ps DE wawcnsceccncecesses United States v. Locke, ED bc vcccwonccceusae United States v. Rutherford, Se TED cecscbecececeseds Weinberger v. Bentex Pharmaceuticals, Inc., Ge ee UD 0 0606s dedweceeees Weiss v. Fujisawa Pharmaceutical Co., 464 F. Supp. 2d 666 (E.D. Ky. 2006) TTT Tr 23 padden 19 sep ae 30 -enee 28 reser 24 rodwus 25 paesséi 20 reer 19 ix Cited Authorities Page(s) FEDERAL STATUTES re 6 EO bo ower eas eee eeews i NS EES rrr reer re or re. 3 ie we id a ee ada ee eels 3 CE I eS ee se 18 is 4. 2s ete ile hes Ga noeee nee 18 scbs ts vee tiveadegee weakens 18 ee itis kuckistehevens Perivascular extravasation occurs when a drug administered intravenously leaks out of the vein into the surrounding tissue, where it may come into contact with arterial blood. App. 4a, 42a. Perivascular extravasation occurs through no fault of the physician or the drug manufacturer. App. 42a. 7 through a series of communications and at least one in-person meeting to refine Phenergan’s warnings with respect to [V push administration. As of at least 1974, Phenergan’s label made clear that intramuscular (““IM”’) injection was the “preferred parenteral route of administration” and advised that IV administration was “well-tolerated” but “not without some hazard” because gangrene could result from exposure of Phenergan to arterial blood. App. 53a. As of 1981, the Phenergan label included the following language: ““When administering any irritant drug intravenously, it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily” — i.e., through IV drip administration. App. 54a (emphasis added). While FDA noted its preference for the IV drip method, it never suggested that the [V push method of injection should be contraindicated or foreclosed. In 1987, after Wyeth complied with a general FDA mandate to reformat Phenergan’s labeling and submit it by a supplementa: New Drug Application (“sNDA”) for approval, FDA recommended revisions concerning the “recognition and management of unintended intra-arterial injection.” App. 150a- 157a. These changes included an enhanced instruction concerning IV drip administration: “Injection through a properly running intravenous infusion [set] may enhance the possibility of detecting arterial placement. In addition, this results in delivery of a lower concentration of any arteriolar irritant.” App. 152a. Again, however, FDA never suggested that the IV push method should be contraindicated or foreclosed. On May 3, 1988, Wyeth submitted new draft labeling for FDA approval that essentially incorporated FDA’s recommended changes relating to IV drip administration: “Injection into an intravenous infusion set that is known to be running properly should decrease the possibility of inadvertently injecting 8 promethazine intra-arterially. In addition, this results in delivery of a lower concentration of any arteriolar irritant.” App. 54a. In 1997 — explaining that it had taken extra time to review Phenergan’s proposed labeling changes to ensure that it had “dotted every ‘i’ and crossed every ‘t’” — FDA specifically ordered Wyeth to “[rJetain [the] verbiage in [the] current label” concerning inadvertent intra-arterial injection and to make other labeling changes. App. 158a-159a, 162a. Wyeth submitted a revised draft package insert on May 8, 1998 in compliance with FDA’s orders. FDA then approved that labeling and expressly commanded Wycth that “(tthe final printed labeling (FPL) for the package insert must be identical to the draft package insert submitted May 8, 1998.” App. 165a (emphasis added). FDA’s consistent decision not to foreclose IV push administration of | aenergan reflected a classic balancing of risks and benefits. The beneficial effects of IV injection generally begin within five minutes; IV drips (when equipment is available) are slower to administer, and IM injection can require twenty minutes or more to take effect. App. 165a. This is no small difference: extreme nausea can cause a patient to lose fluids quickly, which leads to dehydration, a serious medical condition. A doctor, confronted with a patient in dire need of relief from nausea, could reasonably decide that the benefits of IV push administration would warrant taking its increased nsk.’ 3. The Operative Phenergan Label when Respondent Was Treated In 2000, as a result of the foregoing FDA oversight over a 45-year period and a series of revisions, Phenergan’s two-page label included repeated, prominent notice of the risk of gangrene arising from inadvertent arterial exposure in no fewer than four ‘ Moreover, under certain circumstauces, IM injection is unreliable or ineffective, such as in the treatment of overweight patients and patients with poor blood flow to the various muscle groups due to dehydration or cardiac disease. In such a situation, a doctor could determine that TV push injection is the only way to provide the patient with the needed relief. 9 separate sections — i.e., “Contraindications,” “Warnings,” “Adverse Reactions,” and “Dosage and Administration.” Two such sections provided the following notice in upper-case type: INADVERTENT INTRA-ARTERIAL INJEC- TION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY. App. 4a, 167a. The label further warned that: Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation cr inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of Phenergan Injection, usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical imitation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. App. 4a, 167a. The label also included lengthy instructions concerning the means of minimizing this risk in both the “Dosage and Administration” and “Warnings” sections. App. 167a. 4. The Administration of Phenergan to Respondent On April 7, 2000, Respondent sought treatment from Northeast Washington County Community Health, Inc. (the “Health Center”) for a severe migraine headache and associated nausea and dehydration. App. 2a. Respondent was initially treated with Phenergan via IM injection, the preferred method of administration. App. 2a. Respondent returned to the Health Center later that day because she had not obtained effective relief. App. 2a. A second dose of Phenergan was then administered directly into Respondent's vein via IV push injection. App. 2a. Phenergan’s FDA-approved label specifically instructed practitioners to proceed with extreme caution in any administration; the administering physician assistant was aware of these instructions and of the risk of arterial exposure through misinjection. 2 es 10 Respondent thereafter developed the symptoms of arterial exposure and had to have her forearm amputated. App. 2a. Before the commencement of this case, Respondent sued the health care providers for malpractice and settled for $700,000. B. Proceedings Below 1. The Trial Court Proceedings Respondent brought state-law-based liability claims against Wyeth on the theory that Wyeth should have revised Phenergan’s FDA-approved label to bar [V push administration. App. 38a, 4a. The jury returned a verdict in favor of Respondent, who was ultimately awarded $ 6,774,000. App. 3a. Wyeth sought judgment as a matter of law on the ground that federal law preempted Respondent’s claims. The trial court denied Wyeth’s motion, issuing an opinion independently addressing preemption as a matter of law. App. 4a, 74a. In its view, FDA’s CBE regulation, 21 C.F.R. § 314.70, “permit[s]} strengthened warnings without approval on an interim basis,” App. 64a, such that Wyeth could be required to conform its labeling to common law tort duties. The court acknowledged the inevitable differences between FDA’s comprehensive balancing of public safety and efficacy interests and the tort precess, which views “the matter in hindsight through the lens of a single catastrophic case,” App. 62a, but still found that the jury’s state-law-based judgment presented no obstacle to FDA’s regulatory objectives, App. 63a. 2. The Appeal to the Vermont Supreme Court Wyeth timely appealed to the Vermont Supreme Court. Wyeth contended that the tral court erred, inter alia, by failing to hold that Respondent’s common law claims were preempted because: (1) Wyeth would have been unable to comply with both Vermont’s common law duty to foreclose IV push injection and FDA’s directive, as evidenced by the drug’s approved label, to retain it; and (2) the claims would obstruct the full accomplishment of FDA's risk-benefit objective to optimize use of Phenergan by imposition of a duty to foreclose [V push injection. App. Sa-6a. The Vermont Supreme Court rejected both arguments and affirmed the trial court’s decision. App. | 9a, 28a. The court first rejected Wyeth’s claim that it would be impossible for Wyeth to comply with both a Vermont common law duty to foreclose IV push injection and a federal duty to use an FDA-approved label that allowed the drug to be administered in this fashion. Like the trial court, the Supreme Court relied on the CBE regulation, 21 C.F.R. § 314.70(c). In the court’s view, “FDA approval of a particular label does not preempt a jury finding that the label provided insufficient warning, as defendant was free under § 314.70(c) to strengthen the warning without prior FDA approval.” App. | 7a. The court also declined to accord any significance to FDA’s directive to Wyeth to “[r]etain verbiage in current label.” App. 17a. The court next refused to consider Wyeth’s claim that Vermont's decision to impose a state tort law duty on Wyeth created an obstacle to the objectives of the FDA regulatory regime. The court held that all such “obstacle” preemption claims were foreclosed by language in the 1962 amendments to the FDCA that premised preemption on a “direct and positive conflict between such amendments and [a] provision of State law.” App. 21a (quoting Drug Amendments of 1962, § 202, 76 Stat. at 793, App. 1 12a). The court reasoned that section 202 restated the standard for “impossibility” preemption and thus “remove[d] from ... consideration the question of whether common-law tort claims present an obstacle to the purposes and objectives of Congress.” App. 21a. Last, the court refused to give any weight to FDA’s formal preemption analysis. Specifically, in a regulatory preamble to recent amendments to its labeling rule, FDA rejected the positions adopted by many federal courts and the Vermont Supreme Court that (1) section 314.70 broadly permits manufacturers to make unilateral labeling changes and (2) “[s}]tate law serves as an appropriate source of supplementary safety regulation for drugs by encouraging or requiring manufacturers to disseminate risk information beyond that required by FDA under the act.” App. 24a (quoting 71 Fed. 12 Reg. at 3934, App. 126a). To the court, FDA’s analysis was “neither an authoritative interpretation of an ambiguous statutory provision entitled to deference, nor a persuasive policy statement entitled to respect.” App. 28a (internal citation omitted). Chief Justice Reiber dissented. The Chief Justice first concluded that an “actual conflict” existed between the jury verdict and federal law because “the FDA clearly addressed the risks attending IV administration of the drug[,] .. . approved IV administration generally, and specifically warned of the dangers of direct IV administration, including inadvertent arterial injection possibly resulting in amputation.” App. 38a. “These assessments are, in fact, the very essence of the FDA’s approval and are in furtherance of the federal objective of advancing public health by balancing the risks and benefits of new drugs and facilitating their optimal use.” App. 38a. The Chief Justice also found that Wyeth was not “‘free’ to change drug labels under [section] 314.70” because the purpose of this regulatory provision “ts to allow manufacturers to address newly discovered risks.” App. 39a-40a. Here, not only was there a complete absence of new evidence concerning IV push administration of Phenergan, but “FDA had already evaluated the risk of inadvertent arterial injection .. . and had mandated warming language for the label to reflect that risk assessment” in its 1997 directive to Wyeth. App. 40a. Wyeth thus “could not both list all forms of IV administration as an approved use, as required by the FDA, and exclude all or some forms of IV administration as unsafe, as required by the jury’s verdict in this case.” App. 43a. The Chief Justice next rejected the majority’s view that the section 202 “direct and positive conflict” language forbade the court from assessing whether state tort law obstructed the federal purposes and objectives served by FDA’s regulatory regime. App. 44a-45a. On the merits of Wyeth’s argument, the Chief Justice concluded that “obstacle preemption” applied in this case under the reasoning of Geier v. American Honda Motor Co., 529 U.S. 861 (2000). App. 45a. The Chief Justice 13 analogized the federal safety standard at issue in Geier — which “allow[ed] a choice of passive restraint systems while not mandating any particular system” and “was a deliberate decision that reflected a balance of diverse policy concerns” — with FDA’s risk-benefit balancing judgment, which “considers various policy factors that are sometimes in tension with one another” to “maximize the availability of beneficial treatments.” App. 48a. According to the Chief Justice, FDA’s conclusion that “Phenergan is safe and effective when delivered through IV administration” preempts any tort duty that would require Wyeth to bar that particular use. App. 48a. REASONS FOR GRANTING THE PETITION The Vermont Supreme Court held that a manufacturer may be liable under state law for failing to bar a particular method of administration of a prescription drug. The federal agency expert in evaluating the safety and efficacy of drugs had concluded that this highly potent method of administration should remain available and directed the manufacturer to retain a label that, while urging prescribers to use extreme care in administering the drug, nonetheless retained it as a medical option. This case thus presents a direct conflict between the considered labeling decision of a federal agency exercising its ex ante responsibility to make comprehensive public health judgments and an ex post case-specific determination of one state jury that the federally approved labeling was inadequate. Unfortunately, this conflict is far from uncommon. There are tens of thousands of individual claims, and potentially millions of class action claims, currently pending in the lower federal and state courts, in which plaintiffs contend that a manufacturer’s use of FDA-approved labeling for its prescription drug is inadequate to satisfy state-law duties to warn.* Divided lines of authority already have emerged and are * See, e.g., In re Bextra & Celebrex Marketing, Sales Practices & Prods. Liab. Lit., No. 05-cv-01699-CRB (N.D. Cal.) (litigation consists of over 1,800 lawsuits); Jn re Prempro Prods. Liab. Litig., No. 4:03C V01507 (F.D. Ark.); In re Vioxx Marketing, Sales Practices & (Cont'd) 14 highly unlikely to be reconciled by further lower court decisions. By deciding key preemption issues here on a record that squarely and cleanly presents them,’ this Court can forestall erroneous decisions in numerous cases and the huge expenditure of resources required to correct those errors and reprocess the underlying cases. The Vermont Supreme Court made basic and fundamental doctrinal errors in its preemption analysis. Wyeth has consistently argued that a jury verdict premised on the alleged inadequacy under state law of an FDA-approved prescription drug label is preempted when it “actually conflicts” with the federal drug labeling regime. State law “actually conflicts” with federal law when “compliance with both federal and state regulations is a physical impossibility,” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963), or when state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” Hines v. Davidowitz, 312 U.S. 52, 67 (1941). These bedrock principles apply with equal force to federal regulations, see Fidelity Federal Savings & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982), and do not differentiate between common law rules arising from state jury verdicts and positive legislative enactments, see Cipollone v. Liggett Group, Inc., 505 U.S. 504, 522 (1992). Prescription drug labeling cases implicate both species of conflict preemption. | Determining whether state tort claims “actually conflict” (Cont'd) Prods. Liab. Litig., No. 05-MDL-1657 (E.D. La.) (approximately 27,400 lawsuits, including over 46,100 plaintiff groups, and approximately 264 putative class actions as of December 2006). Individual suits like that presented here are almost too numerous to count. * This case presents an ideal vehicle for resolving these legal issues because the facts underlying the preemption question are not in dispute. There is no allegation that Wyeth had failed to react to safety information not considered by FDA or that Wyeth breached any other state law duty that might make the Vermont Supreme Court’s mistaken preemption analysis insufficient to reverse the judgment. 15 with FDA prescription drug labeling rules requires resolution of three key legal questions. First, does FDA’s labeling regime developed under congressional mandate provide only a minimum safety standard open to unlimited state supplementation or a fully calibrated risk-benefit balance of national applicability that state law should not disrupt? Second, are principles of “obstacle” conflict preemption trumped in prescription drug cases either by a presumption against preemption or by a statutory requirement that preemption arise from a “direct and positive” conflict? Third, should weight be given in the preempti- = analysis to FDA’s recent formal assessment of the adverse impact of tort actions on the integrity of its labeling regime? The Vermont Supreme Court answered al! of these questions incorrectly. First, it concluded — contrary to the agency’s view of its own regulations — that FDA’s labeling requirements merely provided a “floor” and that a manufacturer was free unilaterally to change its labeling without prior FDA approval. Second, the court erroneously declined even to consider whether the state tort law duty would “stand as an obstacle” to the effectiveness of federal drug regulation, mistakenly reading a provision in the FDCA as precluding this entire line of traditional preemption analysis. Finally, the court dismissed FDA's carefully considered judgment that tort suits like the instant one disrupt the agency's ability to ensure that the optimal information about the risks and benefits of using prescription drugs is provided to prescribers. Each of these conclusions was erroneous, and each independently warrants reversal. I. The Court Should Grant Review To Correct Vermont’s Rejection of Impossibility Conflict Preemption Stemming from its Mischaracterization of FDA’s Comprehensive Regulatory Regime. The Vermont Supreme Court's opinions in this case exemplify an ongoing dispute in the lower courts as to whether FDA's labeling approvals establish only a minimum requirement (“floor”) for safety-related disclosures or, alternatively, a 16 calibrated approach (‘floor and ceiling”) that neither underwarns nor overdeters effective use. This base disagreement is very often outcome determinative and has been characterized by FDA as a threat to the integrity of its comprehensive regulatory regime. See 71 Fed. Reg. at 3934, App. 130a (“FDA has learned of several instances in which product liability lawsuits have directly threatened the agency’s ability to regulate manufacturer dissemination of risk information for prescription drugs in accordance with the act.”’). A majority of the Vermont Supreme Court adopted the former view in this case, following a line of cases holding that “FDA’s drug labeling decisions impose only ‘minimum’ standards that are open to supplementation by state law through a jury’s verdict enforcing a manufacturer’s common law duty to warn.” Caraker v. Sandoz Pharm. Corp, 172 F. Supp. 2d 1018, 1033 (S.D. Ill. 2001); Mazur v. Merck & Co., 742 F. Supp. 239, 247 (E.D. Pa. 1990) (“Manufacturers must meet state safety requirements, whether codified or embodied in the common law, in addition to satisfying initial FDA requirements.”); Cartwright v. Pfizer, Inc., 369 F. Supp. 2d 876, 883 (E.D. Tex. 2005) (“FDA only sets forth minimum standards for labeling and safety of drugs.”); McNellis v. Pfizer, Inc., No. Civ. 05- 1286, 2005 WL 3752269, at *7 (D.N.J. Dec. 29, 2005) (“FDA's regulations do not conflict with New Jersey’s failure to warn law because those federal regulations merely set minimum standards with which manufacturers must comply.”’), stay granted and motion to certify appeal granted, No. Civ. 05-1286 (JBS), 2006 WL 2819046 (D.N.J. Sept. 29, 2006). Under this approach, state labeling requirements — whether imposed through positive legislative enactments or judicial decree — can almost never be incompatible with FDA’s labeling regime. App. |5Sa (“When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA’s continued approval of its labels as a shield against state tort liability.”). Chief Justice Reiber’s dissent looked to different authority holding that “inadequate warning claim[s] would . . . conflict 17 with the federal requirements imposed during the regulation of” the prescription drug by, “in effect, allowing a state regulation to impose labeling requirements contrary to those required by federal law.” Needleman v. Pfizer, Inc., No. 3:03-CV-3073-N, 2004 WL 1773697, at *2 (N.D. Tex. Aug. 6, 2004); /n re Bextra & Celebrex Marketing Sales Practices & Prod. Liab. Litig., No. 05-1699, 2006 WL 2374742, at *10 (N.D. Cal. Aug. 16, 2006) (“Plaintiffs’ state law failure-to-warn-claims conflict with the FDA’s determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the FDCA.”); Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189, 1198 (D.N.D. 2002) (finding that prescription drug warning claim was preempted where “FDA dictates the contents of the label” and where “defendants were prohibited from changing it without prior approval from the FDA, except in limited circumstances for a limited period of time”’), aff ‘d, 367 F.3d 1013 (8th Cir. 2004). As Chief Justice Reiber explained, it would have been literally impossible for Wyeth to have complied with both the duty newly imposed under Vermont common law and FDA’s command that Phenergan be marketed under labeling identical to that submitted by Wyeth on May 8, 1998. Respondent’s cause of action onginated from — and inis case ultimately turned on — the premise that Phenergan’s labeling should have foreclosed IV push administration of Phenergan. App. 37a (“[W]hat plaintiff sought was an elimination of a use of Phenergan that had been approved by the FDA.”) (Reiber, C.J., dissenting). Thus, Wyeth could have complied with the legal duty it allegedly breached under Vermont law only if it had modified its FDA- approved label without prior FDA authorization before April 7, 2000, when Respondent was injected. Unless federal law permitted such modification, well-established conflict preemption principles would preclude holding Wycth liable for failing to follow a state mandate that would have forced it to violate federal law. See Freightliner Corp. v. Myrick, 514 US. 280, 287 (1995). 18 No FDCA provision authorizes manufacturers to modify FDA-approved labeling without prior FDA consent. Indeed, as the Vermont Supreme Court acknowledged, the FDCA conditions the right to ship prescription drugs in interstate commerce on the use of FDA-approved labeling. As FDA routinely advises manufacturers receiving New Drug approvals, “[mJarketing the product with [labeling] that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug.” Letter from Edward Cox, Acting Director, Center for Drug Evaluation and Research, to David Hallinan, VP Regulatory Affairs, Idenix Pharms., Inc. (Oct. 25, 2006), available at http://www.fda.gov/cder/foi/appletter/2006/ 02201 15000ltr.pdf (approving NDA 22-011 (Tyzeka)); see also App. 165a (commanding that Phenergan’s “final printed labeling . must be identical to the [FDA-approved] draft package insert”). Marketing a misbranded or unapproved prescription drug would subject the manufacturer to substantial criminal and civil penalties. 21 U.S.C. §§ 332(a), 333(a), 334. To meet the need to disseminate newly discovered safety information without delay, FDA adopted its “change being effected,” or “CBE,” regulation, 21 C.F.R. § 314.70(c)(6)(iii), in 1982. Rather than properly interpreting that regulation as a limited exception to FDCA’s pre-approval labeling regime, however, courts adopting the “minimum” standards approach have seized on it to open the door to far-reaching state safety regulation. The CBE regulation descnbes certain categories of interim labeling changes that manufacturers may make without prior FDA approval, including “[t]o add or strengthen an instruction about dosage or administration that is intended to increase the safe use of the drug product.” /d. § 314.70(c)6)(ii(C). Under the Vermont court’s construction, this regulation allows “unilateral changes to drug labels whenever the manufacturer believes it will make the product safer, and places no limit on the duration of pre-approval warnings unless the FDA disapproves of the change.” App. 13a (citation omitted); see also Caraker, 172 F. Supp. 2d at 1034 (“Even after approval, additional or more forceful warnings may, 19 in the drug manufacturer’s judgment, be added to labeling without prior FDA approval and on the drug manufacturers’ own initiative.”). Thus, “[w]hile specific federal labeling requirements and state common-law duties might otherwise leave drug manufacturers with conflicting obligations, § 314.70(c) allows manufacturers to avoid state failure-to-warn claims without violating federal law.” App. | 1a (citation omitted). This expansive and result-oriented reading of the CBE regulation is clearly incompatible with FDA’s overall regulatory labeling regime. As FDA explained in adopting the CBE provision in 1982, that regulation creates a limited exception to the general pre-approval regime to permit newly discovered information to be timely disseminated. See New Drug and Antibiotic Regulations, 47 Fed. Reg. 46,622, 46,623, 46,635 (Oct. 19, 1982) (codified at 21 C.F.R. pts. 310, 312, 314, 430, 431, 433); see also Perry v. Novartis Pharma. Corp., 456 F. Supp. 2d 678, 682 (E.D. Pa. 2006) (“This particular regulation was promulgated precisely to allow drug-makers to quickly strengthen label warnings when evidence of new side effects are discovered.” (emphasis added) (internal quotation marks and citation omitted)); Weiss v. Fujisawa Pharm. Co., 464 F. Supp. 2d. 666, 675 (E.D. Ky. 2006) (explaining that a “drug manufacturer may warm patients and healthcare providers should they discover new evidence of a particular risk following the approval of the original label” (emphasis added)). While a “new information” trigger for using the CBE provision is not express in its text, it is necessarily implicit in FDA’s larger regulatory scheme. See Labeling and Prescription Drug Advertising; Content and Format for Labeling for Human Prescription Drugs, 44 Fed. Reg. 37,434, 37,447 (June 26, 1979) (codified at 21 C.F.R. pts. 201-202); 71 Fed. Reg. at 3934, App. 128a-132a. FDA’s comprehensive, particularized regulation of label formats and wording at the time of NDA approval cannot be reconciled with according manufacturers thereafter an unlimited ability to modify critical label language without prior FDA approval. See Smith v. United States, 508 U.S. 223, 234 (1993) (“A provision . . . lS often clanfied by the remainder of the statutory scheme . . . 20 because only one of the permissible meanings produces a substantive effect that is compatible with the rest of the law.” (internal quotation marks and citation omitted)). In the words of Chief Justice Reiber, “the regulation does not allow manufacturers to simply reassess and draw different conclusions regarding the same risks and benefits already balanced by the FDA.” App. 40a. The facts of this case clearly show how the FDA regime can be disrupted by the CBE minimum standards approach. Here, the record unequivocally established that all information relating to the risks of IV injection of Phenergan put before the jury was available to FDA when it.acted on Wyeth’s supplemental NDA in 1997. The Vermont judicial process simply differed with FDA on the risk-benefit assessment appropriate to these facts, thus turning the CBE regulation into a recipe for balkanized and unbounded state second-guessing of federal regulatory actions. See App. 65a (calling FDA’s regulatory process “slow and imperfect” and suggesting that FDA did not review “intravenous administration of Phenergan with scientific ngor or any sense of urgency”). This Court and the federal courts of appeal consistently have made clear that Congress has safeguarded FDA's science-based discretionary decisions from second-guessing in the federal courts, let alone fifty state courts. See, e.g., Heckler v. Chaney, 470 U.S. 821, 835 (1985); see also Weinberger v. Bentex Pharms., Inc.,412 U.S. 645, 653-54 (1973) (“The determination whether a drug is generally recognized as safe and effective . . . necessarily implicates complex chemical and pharmacological considerations” and is “peculiarly suited to initial determination by the FDA.”): Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033, 1043 (10th Cir. 2006) (“The review of scientific literature is properly m the province of the FDA, to which this Court grants deference based on its expertise.”); Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir. 1995) (“[FDA’s] judgments as to what is required to ascertain the safety and efficacy of drugs fall squarely within the ambit of the FDA’s expertise and merit deference from us.”’). Distorting the CBE regulation to permit second-guessing by judges and junes in prescription drug injury cases, as occurred here, 21 is particularly pernicious. While FDA makes risk-benefit labeling decisions from a systemic, forward-looking perspective to optimize use of beneficial treatments, supra at 4, state judicial decisions make the same determinations “in hindsight through the lens of a single catastrophic case,” App. 62a, and with an inevitable bias toward finding fault as a basis for compensation. Were manufacturers to labei in response to, or in anticipation of, state determinations, they would be subject to myriad conflicting mandates, and numerous FDA judgments concerning optimal labeling and administrations of prescription drugs could be overridden, to the detriment of overall public health. See Horn v. Thoratec Corp., 376 F.3d 163, 178 (3d Cir. 2004) (observing that excessive risk-oriented regulation “can harm the public health ... by encouraging ‘defensive labeling’ by manufacturers to avoid state liability, resulting in scientifically unsubstantiated warnings and underutilization of beneficial treatments”). This Court should grant review to restore the integrity of FDA’s regulatory regime in a “case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers.” Medtronic Inc. v. Lohr, 518 U.S. 470, 501 (1996). At least absent newly discovered scientific information permitting action under section 314.70(a), manufacturers like Wyeth should not be held liable for adhering to an FDA- approved label. Il. The Court Should Grant Review To Clarify the Effect, If Any, of the Presumption Against Preemption and Section 202 of the 1962 FDCA Amendments on the Application of “Obstacle” Conflict Preemption to Prescription Drug Cases. Review also would allow the Court to articulate the analytical framework for applying conflict preemption principles id 22 to the prescription drug regime when FDA's labeling regime permits manufacturers to initiate some modifications. Even if states have some authority to regulate such discretion as FDA affords to manufacturers, well-establis»ed principles of preemption forbid states from exercising that authority in a manner that would obstruct the objectives of federal law. See McDermott v. Wisconsin, 228 U.S. 115, 132 (1913) (“[T]o the extent that state law interferes with or frustrates the operation of the acts of Congress, its provisions must yield to the superior Federal power. . . .”). This Court has consistently made clear that conflict preemption analysis requires consideration both of whether it would be impossible to comply with federal and state law and of whether the state law would stand as an obstacle to the objectives of federal law: The Court has not previously driven a legal wedge - only a terminological one — between “conflicts” that prevent or frustrate the accomplishment of a federal objective and “conflicts” that make it “impossible” for private parties to comply with both state and federal law. Rather, it has said that both forms of conflicting state law are “nullified” by the Supremacy Clause, and it has assumed that Congress would not want either kind of conflict. Geier, 529 U.S. at 873 (citations omitted). The Vermont Supreme Court majority, however, simply declined to analyze obstacle preemption. The court determined that this line of inquiry was foreclosed by sect‘on 202 of the 1962 amendments to the FDCA, which it read as limiting the operation of preemption to cases in which it ts impossible for a manufacturer to comply with both state and federal law. App. 22a (“[U]nder any circumstances where it is possible to comply with both state law and the FDCA the state law in question is consistent with the purposes and objectives of Congress.”). The majority attempted to bolster its conclusion by relying on a “presumption against preemption” of state regulatory powers in the area of public health. App. 23a-24a. 23 The majority’s construction of section 202’s “direct and positive” language is mistaken. This Court has made clear that the existence of such savings clauses specifically designed to protect the operation of state law does not preclude application of conflict preemption — including obstacle preemption. See Geier, 529 U.S. at 373-74 (“The Court has thus refused to read general “saving” provisions to tolerate actual conflict both in cases involving impossibility and in frustration-of-purpose cases. ...” (internal quotation marks and citations omitted)). Instead of foreclosing conflict preemption, such provisions — within an otherwise comprehensive regulatory scheme — ave best read to indicate Congress’s intent merely to preclude field preemption — on which Wyeth does not rely. See Schneidewind v. ANR Pipeline Co., 485 U.S. 293, 299-300 (1988). That is precisely the effect of section 202. Because the 1962 FDCA amendments greatly expanded FDA’s regulatory authority, there was legitimate concern that Congress might have been deemed to occupy the field of drug safety. The use of the phrase “direct and positive” was intended to preclude field preemption while fully preserving conflict preemption, nothing more. As the House sponsor of section 202 explained, this provision “would merely say that this Food and Drug Act shall not be construed as the intent of Congress to abolish a// State laws on the same subject where they are not in conflict with the Federal law.” See 108 Cong. Rec. 21,083 (1962) (statement of Rep. Smith) (emphasis added). Indeed, courts determining whether a “direct and positive” conflict exists routinely conduct both an impossibility conflict and an obstacle conflict preemption analysis and make clear that this language operates only to bar field preemption. See, e.g., Sinnot v. Davenport, 63 U.S. (22 How.) 227, 242-43 (1859) (finding “direct and positive” conflict between federal and state law coasting trade provisions despite vessel owner’s ability to comply with both and holding that “if this State law can be upheld, the full enjoyment of the right to carry on the coasting trade . . . is denied to the vessel in question”); City of Camden vy. Beretta U.S.A. Corp., 8\ F. Supp. 2d 541, 549 (D.N.J. 2000) (finding that Gun Control Act's 24 “direct and positive conflict” phrase “compels a finding that the Gun Control Act only may be raised as an ordinary preemption defense to a conflicting state Jaw, and not as a jurisdictional bar to all state claims relating to firearms” (internal quotation marks omitted)).° The general presumption against preemption does not alter this result. The presumption is designed to ensure that “the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purnose of Congress.” Rice v. Santa Fe Elevator Corp., 33\ U.S. 218, 230 (1947). Importantly, however, this presumption “is not triggered when the State regulates in an area where there has been a history of significant federal presence.” United States v. Locke, 529 U.S. 89, 108 (2000); see also Int'l Paper Co. v. Ouellette, 479 U.S. 481, 491 (1987) (“[I]t is not necessary for a federal statute to provide explicitly that particular state laws are pre-emptec.”). In this regard, FDA has observed that “[i}n determining the proper role for state law in this context, . . . it is significant that the federal government has been regulating the meaufacture and sale of drugs since 1906” — i.e., for more than a century. Br. of the United States as Amicus Curiae in Support of Defendants-Appellees (filed Dec. 4, 2006), Colacicco v. Apotex, Inc., No. 06-3107 (3d Cir.), at 17-18 n.7 (“Colacicco Br.”). Granting review would enable this Court to make clear that state courts are not free simply to ignore this Court's settled “obstacle” conflict preemption doctrine through the overzealous application either of “direct and posiiive conflict” provisions or of the presumption against preemption. The Vermont court should have examined whether the common law duty imposed on Wyeth posed an obstacle to FDA's * This Court also has made clear that a federal statute's use of the term “provision” refers to positive enactments - not tort suit judgments. See Cippollone v. Liggett Group. Inc., SOS U.S. 504, 518 (1992); see also Black's Law Dictionary 1262 (8th ed. 2004) (defining “provision” as “[a] clause im a statute, contract, or other legal instrument”). By its express terms, section 202 thus would not bar obstacle preemption even under the Vermont majority's misconstruction. 25 accomplishment of its congressionally mandated regulatory objectives. Under that analysis, the jury’s verdict is preempted. As explained supra at 3, Congress specifically charged FDA with optimizing the use of prescription drugs by balancing their risks against their benefits to the overall public health. Permitting state tribunals to impose differing risk-benefit judgments on manufacturers, and to coerce labeling changes that FDA would not accept, would defeat congressional intent and lead to conflicting safety and warning standards imposed through the backward-looking lens of individual claims instead of the forward- looking public health determination that Congress mandated. The facts of this case demonstrate why a state court’s backward-looking, case-specific focus is inconsistent with FDA’s broader regulatory perspective. FDA evaluated the risks associated with IV injection of Phenergan over a period of decades. Based on its scientific expertise, FDA determined that the efficacy benefits outweighed the nsks and that physicians should retain the option to administer Phenergan via IV push, taking account of the extensive precautions and warnings in the approved label. App. 167a. FDA’s determinations reflect its considered judgment that Phenergan’s label reflected the correct risk-benefit balance and thus would render the drug of greatest benefit to the greatest number of people. See United States v. Rutherford, 442 U.S. 544, 555 (1979) (“[FDA] generally considers a drug safe when the expected therapeutic gain justifies the risk entailed by its use.”). The Vermont Supreme Court would allow a jury to disagree with FDA’s risk-benefit assessment and to override the federal regime by imposing a different labeling regime on Wyeth. This 1s a paradigmatic case of state law frustrating the objectives and purposes of a federal regulatory regime by foreclosing a treatment option that the federal government has decided to hold open. As this Court made clear in Geier, such interference cannot survive constitutional scrutiny. In Geier. this Court held that a state common law duty to install airbags in all cars was preempted where federal regulation “deliberateiy 26 provided the manufacturer with a range of choices among different passive restraint devices.” 529 U.S. at 875. Geier held that the state duty “would have presented an obstacle to the variety and mix of devices that the federal regulation sought” and “‘stood as an obstacle to the general passive restraint phase- in that the federal regulation deliberately imposed.” /d. at 881; see also Int'l Paper Co., 479 U.S. at 494 (striking down state law under conflict preemption that “upset{] the balance of public and private interests so carefully addressed by the [federal] Act”); Buckman Co. v. Pls.’ Legal Comm., 531 U.S. 341, 348 (2001) (observing that FDA uses its authority “to achieve a somewhat delicate balance of statutory objectives” and that this balance “can be skewed by allowing” state tort law claims that second- guess FDA’s enforcement decisions). Just as the petitioner in Geier could not use tort law to foreclose choices that the Department of Transportation deemed appropriate, Vermont here cannot be permitted to disturb the hierarchy of options for Phenergan administration that FDA repeatedly chose to preserve in Phenergan’s labeling. This Court should grant certiorari and reverse the decision below so that lower courts will undertake the careful review necessary to determine whether compliance with a state-enforced duty, even if not expressly foreclosed by federal command, would, as here, obstruct rather than complement the objectives and purposcs of FDA regulation.’ ’ Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), is fully consistent with this understanding. In Bates, this Court held that federal law did not expressly preempt “parallel” state law remedies for violation of federal misbranding law. See 544 U.S. at 449-51. Here, unlike Bates, Vermont common law secks to provide litigants a cause of action scparate and distinct from federal law; indeed, the Vermont courts made clear that Wyeth would be held liable irrespective of its fidelity to the federal labeling mandate. App. 28a. Accordingly, the reasoning that saved state “parallel requirements ' from preemption is wholly inapposite here. The Vermont common law rule and FDA’s labeling regime are not parallel. we 27 I1l. The Court Should Grant Review To Resolve the Conflict Concerning the Degree of Deference that Courts Should Accord FDA’s Formal Position on the Extent to Which State Tort Law Labeling Judgments Interfere with FDA’s Labeling Regime. Finally, this Court should grant review to resolve a lower court split on whether FDA’s recently expressed judgments with respect to the adverse impact of state tort suits on its comprehensive prescription drug labeling regime are entitled to deference. In its preamble to an amended labeling regulation, FDA recently reiterated its longstanding view that suits such as this one obstruct its ability to ensure that prescribers receive accurate and helpful information about the proper uses of prescription drugs. See 71 Fed. Reg. at 3935, App. 132a-133a. The agency has explained why, in its expert judgment, additional labeling requirements imposed by state law may interfere with its ability to carry out its congressionally mandated function: State law actions ... threaten FDA's statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs. State actions are not characterized by centralized expert evaluation of drug regulatory issues. Instead, they encourage, and in fact require, lay judges and juries to second-guess the assessment of benefits versus risks of a specific drug to the general public — the central role of FDA - sometimes on behalf of a single individual or group of individuals. That individualized reevaluation of the benefits and risks of a product can result in relief -- including the threat of significant damage awards or penalties - that creates pressure on manufacturers to attempt to add warnings that FDA has neither approved nor found to be scientifically required. This could encourage manufacturers to propose ‘‘defensive labeling’’ to avoid State liability, which, if implemented, 28 could result in scientifically unsubstantiated warnings and underutilization of beneficial treatments. Id. at 3935. This observation, based on FDA’s expertise and experience, fully supports FDA’s view that “[s]tate law conflicts with and stands as an obstacle to achievement of the full objectives and purposes of Federal law if it purports to preclude a firm from including in labeling . . . a statement that is included in [FDA- approved] prescription drug labeling.” /d.; see also id. at 3934 (“FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.”). For all these reasons, FDA reiterated that it “interprets the act to establish both a ‘floor’ and a ‘ceiling,’ such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading.” /d. at 3935." FDA expressed this same view in a number of recent amicus briefs. See, e.g., Colacicco Br., supra; Letter Br. for FDA (filed Sept. 21, 2006), Perry v. Novartis Pharms., No. 05-5350 (E.D. Pa.) (“Perry Br.”). FDA explained therein that, “[i]n that context of drug labeling, Congress has authorized FDA to use scientific expertise to determine, in the first instance, what warnings are appropriate and necessary for a particular drug.” Colacicco Br., supra, at 20. Moreover, “[i]f the agency had made a determination at a relevant time that a particular warning was unsubstantiated or would otherwise render the drug misbranded, then federal preemption bars liability for the failure to provide that warning.” /d. at 23 n.10. Accordingly, “[e}ven if compliance with both state and federal law in these circumstances would not be impossible, state tort liability would pose a sufficient * See Hillsborough County v. Automated Med. Labs., Inc., 47\ U.S. 707, 718 (1985) (confirming that agencies “can speak through a variety of means, including regulations, preambles, interpretive statements, and responses to comments”); Fid. Fed Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 158 (1982) (looking to regulatory preamble “for the administrative construction of the regulation, to which ‘deference is... clearly in order’” (quoting Udall v. Tallman, 380 U.S 1, 16 (1965)). 29 threat to federal regulatory objectives to be preempted under the Supremacy Clause.” Perry Br., supra, at 10.° According to the Vermont Supreme Court, “FDA’s statement is neither an authoritative interpretation of an ambiguous statutory provision entitled to deference, nor a persuasive policy statement entitled to respect.” App. 28a (internal citations omitted); see also Jackson v. Pfizer, Inc. , 432 F. Supp. 2d 964, 968 (D. Neb. 2006) (“The recent notice issued by the FDA claiming preemption is not persuasive.”). In particular, the majority refused to credit FDA’s conclusion that the “direct and positive” language of section 202 did not foreclose an analysis of state law interference with FDA's regulatory objectives. App. 135a, 21a. Other courts have taken a different view of the importance of FDA’s views on how °tate tort suits conflict with its regulatory regime and hamper its ability to do its job. See /n re Bextra, 2006 WL 2374742, *6 (“The FDA’s interpretation of the preemptive effect of its regulations is entitled to deference.”’); Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 525 (E.D. Pa. 2006) (“The FDA’s view is critical to this Court’s analysis because Supreme Court precedent dictates that an agency’s interpretation of the statute and regulations it administers is entitled to deference.”); see also Horn, 376 F.3d at 171 (“[T]he Supreme Court has instructed us that the FDA’s preemption determinations are significant and should inform our interpretation. .. .”). This latter view is correct - FDA’s substantive interpretation of its own regulations should be entitled to considerable deference — not the dismissive treatment given by the Vermont Supreme Court. See Auer v. Robbins, 519 U.S. 452, 461 (1997) * See Geier v. Am. Honda Motor Co., 529 U.S. 861, 883 (2000) (granting deference to the views expressed in an amicus brief submitted by the Solicitor General); Auer v. Robbins, 519 U.S. 452, 453 (1997) (“The Secretary’s interpretation is not rendered unworthy of deference by the fact that it is set forth in an amicus brief; it is not a position adopted in response to litigation, and there is no reason to suspect that it does not reflect the Secretary's fair and considered judgment.”). 30 (holding that an agency’s interpretation of its regulations is “controlling unless plainly erroneous or inconsistent with the regulation” (internal quotation marks and citation omitted)). Similarly, FDA is best able to determine what interferes with its ability to fulfill its statutory mandate, and its views on that issue also merit substantial deference: Congress has delegated to [the agency] authority to implement the statute; the subject matter is technical; and the relevant history and background are complex and extensive. The agency is likely to have a thorough understanding of its own regulation and its objectives and is “uniquely qualified” to comprehend the likely impact of state requirements. Geier, 529 U.S. at 883; see also Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994) (finding that deference is especially warranted where agency decisions “require significant expertise and entail the exercise of judgment grounded in policy concerns” (internal quotation marks and citation omitted)). Prescription drug labeling is precisely the type of complex and technical regulatory regime that warrants deference to the expertise of the agency that Congress charged with administering it. See Bates v. Dow Agrosciences LLC, 544 U.S. 431, 455 (2005) (“As suggested by Medtronic, the federal agency charged with administering the statute is often better able than are courts to determine the extent to which state liability rules mirror or distort federal requirements.”) (Breyer, J., concurring). By disrecarding FDA's interpretation of its own regulations and its views on the impact of state tort suits on the agency's regulatory objectives, the Vermont court committed a crucial error that infected its entire preemption analysis. The Court should grant review to correct this error and resolve this split in authority. CONCLUSION For the foregoing reasons, this Court should grant the petition for a writ of certiorari Respectfully submitted, ALLAN R. Keyes Bert W. Rein R. JosepH O’ RourKE Counsel of Record Ryan, SmitH, Carsine, LTD. Karyn K. ABLIN 98 Merchants Row WILLIAM S. Consovoy P.O. Box 310 Wiey Rem LLP Rutland, VT 05702-0310 1776 K Street NW (802) 786-1000 Washington, D.C. 20006 (202) 719-7000 Attorneys for Petitioner la APPENDIX A — OPINION OF THE VERMONT SUPREME COURT FILED OCTOBER 27, 2006 SUPREME COURT No. 2004-384 Diana Levine v. Wyeth On Appeal from Washington Superior Court October Term, 2005 Geoffrey W. Crawford, J. Richard I. Rubin and Kerry B. DeWolfe of Rubin, Kidney, Myer & DeWolfe, Barre, for Plaintiff-Appellee. Allan R. Keyes and R. Joseph O’Rourke of Ryan, Smith & Carbine, Ltd., Rutland, and Bert W. Rein, Karyn K. Ablin and Sarzh E. Botha of Wiley Rein & Fielding LLP, and Daniel S. Pariser of Arnold & Porter LLP, Washington, D.C., for Defendant-Appellant. Present: REIBER, C.J.,. DOOLEY and JOHNSON, JJ., and MORRIS, D.J., and ALLEN, C.J. (Ret.), Specially Assigned. 2a Appendix A JOHNSON, J. Defendant Wyeth, a drug manufacturer, appeals from a jury verdict in favor of plaintiff Diana Levine, who suffered severe injury and the amputation of her arm as a result of being injected with defendant’s drug Phenergan. Plaintiff claimed at trial that defendant was negligent and failed to provide adequate warnings of the known dangers of injecting Phenergan directly into a patient’s vein. Defendant argues that the trial court should not have allowed the jury to consider plaintiff's claims because the claims conflict with defendant’s obligations under federal law regulating prescription drug labels. We hold that there is no conflict between state and federal law that requires preemption of plaintiff's claim. Defendant also raises two claims of error relating to the jury instructions on damages. We hold that the court’s rulings on these jury instructions were correct, and we affirm. In April 2000, plaintiff was injected with defendant’s drug Phenergan at Northeast Washington County Community Health, Inc. (“the Health Center”). The drug was administered to treat plaintiff's nausea resulting from a migraine headache. Plaintiff received two injections. The drug was first administered by intramuscular injection. Later the same day, when plaintiff's nausea continued, she received a second dose by a direct intravenous injection into her arm, using a procedure known as “IV push.” The second injection resulted in an inadvertent injection of Phenergan into an artery. As a result, the artery was severely damaged, causing gangrene. After several weeks of deterioration, plaintiff's hand and forearm were amputated. 3a Appendix A Plaintiff brought a superior court action for negligence and failure-to-warn product liability, alleging that defendant’s inadequate warning of the known dangers of direct intravenous injection of Phenergan caused her injuries. During a five-day jury trial, both parties presented expert testimony regarding the adequacy of the warnings defendant placed on Phenergan’s label. Plaintiff’s experts testified that the label should not have allowed IV push as a means of administration, as it was safer to use other available options, such as intramuscular injection or administration through the tubing of a hanging IV bag. Defendant’s expert testified that allowing IV push with instructions cautioning against inadvertent arterial injection was sufficient. The court instructed the jurors that they could consider the FDA’s approval of the label in use at the time of plaintiff's injury, but that the label’s compliance with FDA requirements did not establish the adequacy of the warning or prevent defendant from adding to or strengthening the warning on the label. At the conclusion of the trial, the jury found in favor of plaintiff on both the negligence and product-liability claims and awarded her $2.4 million in economic damages and $5 million in non-economic damages. Pursuant to the parties’ stipulation, this award was reduced to a total of $6,774,000 to account for pre-judgment interest and plaintiff's recovery in a settlement of a separate action she had filed against the Health Center. In a summary judgment motion prior to trial, as well as in its timely motion for judgment as a matter of law following trial, both of which the superior court denied, defendant argued that federal law preempted plaintiff's claim. These arguments rested in part on defendant’s contention that it 4a Appendix A had submitted an adequate warning to the FDA, but that the FDA rejectedthe change because it did not favor strengthening the warning.' Plaintiff contended that neither warning would have been adequate. The trial court stated, in 1. The warning on the label that was in use in 2000 read in relevant part: INADVERTENT INTRA-ARTERIAL INJECTION: Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of [Phenergan], usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was intended in all the cases reported but perivascular extravasation or arterial placement of the needle is now suspect. There is no proven successful managemert of this condition after it occurs. . . . When used inti enously [Phenergan] should be given in a concentration no greater than 25 mg per ml and at a rate not to exceed 25 mg per minute. WHEN ADMINISTERING ANY IRRITANT DRUG INTRAVENOUSLY IT IS USUALLY PREFERABLE TO INJECT IT THROUGH THE TUBING OF AN INTRAVENOUS INFUSION SET THAT IS KNOWN TO BE FUNCTIONING SATISFACTORILY. (Emphasis added.) The revised warning the FDA failed to adopt read in relevant part: INADVERTENT INTRA-ARTERIAL INJECTION: There are reports of necrosis leading to gangrene, requiring amputation, (Cont'd) Sa Appendix A its decision on defendant’s motion for judgment as a matter of law, that although the FDA had rejected a new warning, the agency’s “brief comment” failed to explain its reasoning or demonstrate that it “gave more than passing attention to the issue of whether to use an IV infusion to administer the drug. The proposed labeling change did not address the use of a free-flowing IV bag.” The court concluded that there was “no basis for federal preemption” and upheld the jury’s verdict. Defendant claims the superior court erred by: (1) failing to dismiss plaintiff's claim on the basis that the Food and Drug Administration’s approval of the Phenergan label (Cont'd) following injection of [Phenergan], usually in conjunction with other drugs; the intravenous route was intended in these cases, but arterial or partial arterial placement of the needle is now suspect. . . . There is no established treatment other than prevention: 1. Beware of the close proximity of arteries and veins at commonly used injection sites and consider the possibility of aberrant arteries. 2. When used intravenously, |[Phenergan] should be given in a concentration no greater than 25 mg/ml and a rate not to exceed 25 mg/minute. INJECTION THROUGH A PROPERLY RUNNING INTRAVENOUS INFUSION MAY ENHANCE THE POSSIBILITY OF DETECTING ARTERIAL PLACEMENT. IN ADDITION, THIS RESULTS IN DELIVERY OF A LOWER CONCENTRATION OF ANY ARTERIOLAR IRRITANT. (Emphasis added.) 6a Appendix A preempted state common law claims that the label was inadequate; (2) failing to instruct the jury to reduce plaintiff's damages by the amount of fault attributable to the Health Center; and (3) failing to instruct the jury to calculate the present value of plaintiff's damages for future non-economic losses. We reject these claims of error, and we affirm. I. Federal Preemption Defendant’s principal argument on appeal is that the court should have dismissed plaintiff's claim because it was preempted by federal law. Defendant asserts that any state common law duty to provide a stronger warning about the dangers of administering Phenergan by IV push conflicts with the FDA’s approval of the drug’s label. As preemption is a question of law, we review the trial court’s decision de novo. Office of Child Support v. Sholan, 172 Vt. 619, 620, 782 A.2d 1199, 1202 (2001) (mem.). We hold that the jury’s verdict against defendant did not conflict with the FDA’s labeling requirements for Phenergan because defendant could have warned against IV-push administration without prior FDA approval, and because federal labeling requirements create a floor, not a ceiling, for state regulation. The United States Constitution provides that federal law is the supreme law of the land. U.S. Const. art. V1, cl. 2. The Supremacy Clause is the basis for the doctrine of preemption, according to which “state law that conflicts with federal law is ‘without effect.”” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (quoting Maryland v. Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114, 68 L.Ed.2d 576 (1981)). In Cipollone, the Court 7a Appendix A described the relevant analysis for determining whether Congress intended a federal statute to preempt state law: Congress’ intent may be explicitly stated in the statute’s language or implicitly contained in its structure and purpose. In the absence of an express congressional command, state law is pre-empted if that law actually conflicts with federal law, or if federal law so thoroughly occupies a legislative field as to make reasonable the inference that Congress left no room for the States to supplement it. Id. (quotations and citations omitted). Absent clear congressional intent to supersede state law, including state common law duties, there is a presumption against preemption. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (“[B]ecause the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action.”’); Cipollone, 505 U.S. at 516 (“Consideration of issues arising under the Supremacy Clause ‘start|s] with the assumption that the historic police powers of the States [are] not to be superseded by ... Federal Act unless that [is] the clear and manifest purpose of Congress.’” (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 91 L.Ed. 1447 (1947))). This presumption has “add[{ed] force” when there has been a “long history of tort litigation” in the area of state common law at issue. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005). 8a Appendix A Defendant concedes that Congress has not expressly preempted state tort actions through the Food, Drug and Cosmetics Act (FDCA), 21 U.S.C. 4 4 301-399, and that Congress did not intend ‘he FDCA to occupy the entire field of prescription drug regulation. Rather, it asserts that plaintiff's action “actually conflicts with federal law.” Cipollone, 505 U.S. at 516. This requires defendant to show either that “it is impossible for a private party to comply with both state and federal requirements,” or that Vermont’s common law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995) (quotations and citations omitted). Defendant presents two alternative bases for its assertion of conflict preemption: (1) in the specific context of the Phenergan label, the FDA was aware of the dangers of IV- push administration and specifically ordered defendant to use the warning it used, making it impossible for defendant to comply with both its state common-law duty and the requirements of federal law; and (2) by penalizing drug companies for using FDA-approved wording on drug labels, state tort claims like plaintiffs present an obstacle to the purpose of the FDA’s labeling regulations. Before reaching these issues, we briefly examine the FDA’s role in regulating prescription drug labels and the general approach courts have taken to the preemptive effect of federal labeling requirements. 9a Appendix A A. Regulatevy Background Prior to distributing a prescription drug such as Phenergan, the manufacturer must submit a New Drug Application (NDA) for FDA approval. 21 U.S.C, 4 355(a). The FDA must approve the application unless it fails to meet certain criteria, including whether test results and other information establish that the drug is “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof,” whether there is “substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof,” and whether, “based on a fair evaluation of al] material facts, such labeling is false or misleading in any particular.” Id. 4 355(d). “FDA regulations mandate the general format and content of all sections of labels for all prescription drugs as well as the risk information each section must contain,” and “{f]inal approval of the NDA is ‘conditioned upon the applicant incorporating the specified labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed label prior to marketing.”” McNellis v. Pfizer, Inc., 2005 WL 3752269, at *4 (D.N.J.) (citing 21 C.F.R. 4 201.56, 201.57, and quoting 21 C.F.R. 314.105(b)). Once a drug and its label have been approved, any changes to the label ordinarily require submission and FDA approval of a “Supplemental NDA.” /d.; 21 C.F.R. 314.70(b)(2)(v)(A). 19a Appendix A If the NDA process and the submission of changes for FDA approval were the exclusive means of creating and altering prescription drug labels, this might be a very different case. A key FDA regulation, however, allows a drug’s manufacturer to alter the drug’s label without prior FDA approval when necessary. The regulation provides in relevant part: (6) The agency may designate a category of changes for the purpose of providing that, in the case of a change in such category, the holder of an approved application may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change. These changes include, but are not limited to: (111) Changes in the labeling ... to accomplish any of the following: (A) To add or strengthen a contraindication, warning, precaution, or adverse reaction; (B) To add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product{.] 21 C.F.R. § 314.70(c). lla Appendix A Section 314.70(c) creates a specific procedure allowing drug manufacturers to change labels that are insufficient to protect consumers, despite their approval by the FDA. “The FDA’s approved label ... can therefore be said to set the minimum labeling requirement, and not necessarily the ultimate label where a manufacturer improves the label to promote greater safety.” McNellis, 2005 WL 3752269, at *5.° While specific federal labeling requirements and state common-law duties might otherwise leave drug manufacturers with conflicting obligations, 4 314.70(c) allows manufacturers to avoid state failure-to-warn claims without violating federal law. /d. (“[I]t is apparent that prior FDA approval need not be obtained, nor will a product be deemed mislabeled, if the manufacturer voluntarily or even unilaterally strengthens the approved warnings, precautions or potential adverse reactions upon the label pursuant to 21 C.F.R. § 314.70(c)(6)(ii1)(A).”). There is thus no conflict between federal labeling requirements and state failure-to- warn claims. Section 314.70(c) allows, and arguably encourages, manufacturers to add and strengthen warnings that, despite FDA approval, are insufficient to protect consumers. State tort claims simply give these manufacturers a concrete inceritive to take this action as quickly as possible. B. Conflict Preemption in Other Jurisdictions In light of the leeway created by 4 314.70(c) for drug manufacturers to add warnings, courts have been nearly unanimous in holding that state failure-to-warn tort claims do not conflict with federal law. See, e g., McNellis, 2005 WL 3752269, at *7 (“[T]he FDCA and the FDA’s regulations do not conflict with New Jersey's failure to warn law because 12a Appendix A those federal regulations merely set minimum standards with which manufacturers must comply.”). McNellis is the latest in a series of recent cases addressing this issue as it relates to the anti-depressant Zo/oft, which allegedly increases the risk of suicide in some patients. See id., at *7-8 (denying summary judgment and rejecting conflict preemption in Zoloft case); accord Zikis v. Pfizer, Inc., 2005 WL 1126909, at *2-3 (N.D.III.); Witczak v. Pfizer, Inc., 377 F.Supp.2d 726, 729-30 (D.Minn.2005); Motus v. Pfizer, Inc., 127 F.Supp.2d 1085, 1096-1100 (C.D.Cal.2000); see also Cartwright v. Pfizer, Inc., 369 F.Supp.2d 876, 882 (E.D. Tex. 2005) (“With little exception, courts that have considered this exact issue have concluded that state failure to warn claims are not preempted by the FDCA and its attendant regulations.”). Contra Needleman vy. Pfizer, Inc., 2004 WL 1773697, at *1 (N.D. Tex.) (granting summary judgment to the defendant on basis of conflict preemption). The Zoloft cases are representative of a general rule that FDA approval of a drug’s label does not preempt state failure- to-warn claims. See, e.g., Eve v. Sandoz Pharm. Corp., 2002 WL 181972, at *1-3 (S.D.Ind.) (rejecting conflict preemption of failure-to-warn claim regarding the drug Parlodel); Caraker v. Sandoz Pharm. Corp., 172 F.Supp.2d 1018, 1032 (S.D.111.2001) (same); Bryant v. Hoffman-La Roche, Inc. , 262 Ga.App. 401, 585 S.E.2d 723, 725 (Ga.Ct.App.2003) (heart medication); Bell v. Lollar, 791 N.E.2d 849, 854-55 (Ind.Ct.App.2003) (prescription pain medication); Kurer v. Parke, Davis & Co., 2004 WI App 74, 21, 272 Wis.2d 390, 679 N.W.2d 867 (oral contraceptive). But see Eh/is v. Shire Richwood, Inc., 233 F.Supp.2d 1189, 1198 (D.N.D.2002) (granting summary judgment to defendant on basis of conflict preemption of claim regarding the drug Adderall). l3a Appendix A Defendant cites two cases, Needleman and Ehlis, that support the preemptive effect of the FDCA in failure-to-warn cases regarding prescription drug labels. Needleman, 2004 WL 1773697, at *1; Ehlis, 233 F.Supp.2d at 1198. Needleman is not perticularly helpful under the circumstances here. Its holding relied on the facts of the Zo/oft litigation, particularly an FDA statement that the warning advocated by the plaintiff would have been misleading. 2004 WL 1773697, at *1. The courts in the other Zoloft cases took a different approach to the FDA’s statement, in part because the FDA’s statement was not “an official agency position,” and in part because the FDA later retracted its position regarding the link between Zoloft and suicide. See, e.g., Witczak, 377 F.Supp.2d at 730. Here, the FDA has not indicated that a stronger warning would be misleading, so the reasoning of Needleman appears inapplicable to this case. Ehlis interpreted 4 314.70(c) as allowing unapproved changes to a label only temporarily, and only under “limited circumstances.” 233 F.Supp.2d at 1197-98. We can find no support for this interpretation in the language of the regulation, which appears to allow unilateral changes to drug labels whenever the manufacturer believes it will make the product safer, and places no limit on the duration of pre-approval warnings unless the FDA disapproves of the change. 21 C.F.R. 4 314.70(c). Defendant next attempts to draw a comparison to the regulation of medical devices under the FDCA, citing medical device cases in which state tort law has been preempted. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (holding that “fraud- on-the-FDA” claim relating to device regulated by Medical Device Amendments to FDCA was preempted); Horn v. l4a Appendix A Thoratec Corp., 376 F.3d 163, 177 (3d Cir.2004) (holding that failure-to-warn claim was preempted by Medical Device Amendments). We find this analogy unpersuasive. Neither Buckman nor Horn weakens the force of the drug-labeling cases cited above. The claim that was preempted in Buckman was for “fraud on the FDA,” not failure to warn; the Court held that the presumption against preemption applies only when a claim implicates “‘the historic primacy of state regulation of health and safety,” which is not the case when the claim arises from a federal statute. 531 U.S. at 347-48 (quoting Medtronic, 518 U.S. at 485). Plaintiff's negligence and product-liability claims fall squarely withn the scope of traditional state regulation, so it is appropriate to apply the presumption against preemption here. In Horn, the Third Circuit relied on an express preemption clause in the FDCA that relates only to medical devices. 376 F.3d at 176. Because no such clause exists for prescription drugs, Horn’s reasoning does not apply to this case. Finally, defendant cites a third group of cases relating generally to the United States Supreme Court’s recent use of conflict preemption in other fields. This argument relies primarily on Geier v. American Honda Motor Co., 529 U.S. 861, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000). In Geier, the Court held that state tort claims based on the production of automobiles without airbags conflicted with federal regulations making airbags one of several permissible safety equipment options. 529 U.S. at 881. Geier, however, rested on the conclusion that the Department of Transportation’s intent in drafting the regulation at issue was to provide a range of different safety options, thus precluding any state determination that a specific type of equipment should be 1Sa Appendix A required. /d. The history of the regulation at issue indicated that the agency intended to phase in automobiie safety requirements gradually, allowing the public to choose between mandatory seatbelt laws at the state level and a federal passive-restraint requirement. /d. at 880-81. Allowing state tort claims based on the lack of a particular safety mechanism would have conflicted with both the agency’s phase-in plan and its intent to provide consumers with a range of safety options. /d. at 881. The Court explicitly stated that in a different context, an agency could promulgate regulations that provided a floor, but not a ceiling, for state regulation. Id. at 870. The FDA’s labeling requirements are exactly that type of regulation. Section 314.70(c) does not allow us to interpret FDA approval of a drug label as anything but a first step in the process of warning consumers. When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA’s continued approval of its labels as a shield against state tort liability. While a state common- law duty may encourage departure from a label that the FDA has approved in great detail, such a duty does not create a conflict with federal requirements because the FDA and the state share the purpose of encouraging pharmaceutical companies to alter their drug labels when they are inadequate to protect consumers. We agree with the significant majority of courts that state failure-to-warn claims are generally not preempted by federal labeling requiremenis. l6a Appendix A We must now apply this reasoning to defendant’s two original contentions: (1) notwithstanding the fact that it is generally possible for manufacturers to comply with both federal and state law through the procedures created by 314.70(c), the FDA’s specific actions with respect to Phenergan made it impossible for defendant to comply with both federal and state law; and (2) even if plaintiff's claim and the cases cited above do not make it impossible for manufacturers to comply with both state and federal law, they present an obstacle to federal objectives. C. Impossibility of Compliance Defendant contends that in this case, it was impossible to comply with both state and federal law because the FDA prohibited the use of a stronger warning with respect to IV- push administration of Phenergan. This claim is not supported by the evidence defendant presented to the trial court. The record lacks any evidence that the FDA was concerned that a stronger warning was not supported by the facts, that such a stronger warning would distract doctors from other provisions in the drug’s label, or that the warning might lead to less effective administration of the drug. Instead, defendant essentially relies on two factual assertions: 1) the FDA approved the label that was in use in 2000; and 2) the FDA, in reviewing the label for use in a different version of Phenergan, expressed its opinion of the adequacy of the warning in the original label by stating, “Retain verbiage in current label.” AB 5, 5 n. 7 17a Appendix A With respect to defendant’s first assertion, our analysis above demonstrates that FDA approval of a particular label does not preempt a jury finding that the label provided insufficient warning, as defendant was free under 4 314.70(c) to strengthen the warning without prior FDA approval. Defendant’s second assertion depends on the meaning of the instruction, “[rjetain verbiage in current label.” Tort liability for defendant’s failure to strengthen its warningcould have created a direct conflict requiring federal preemption only if the FDA intended the instruction to prohibit any language strengthening the original warning. In other words, unless we interpret the FDA’s statement as evidence that it would have rejected any attempt by defendant to strengthen its label through 4 314.70(c), we cannot conclude that it was impossible for defendant to comply with its state common- law duty without violating federal law. Defendant argues that the instruction reflected the FDA’s opinion not only that a stronger warning was unnecessary, but also that it would have harmed patients by eliminating IV push as an option for administering Phenergan. The record does not support this interpretation. Defendant has provided a number of letters exchanged by the FDA and defendant regarding Phenergan’s label, but these letters do not indicate the FDA’s opinion of the value of I[V-push administration. Neither the letters nor any other evidence presented to the jury indicated that the FDA wished to preserve the use of IV push as a method of administering Phenergan. Nor can we infer such concern from the agency’s instruction to “[r]etain current verbiage” instead of adopting the proposed warning. The specific warning the agency rejected in favor of the original label did not indicate any more clearly than the 8a Appendix A original label that IV-push administration was unsafe, which is what plaintiff argued made the original label inadequate. The FDA could have rejected the new warning for any number of reasons, including clarity or technical accuracy, without implicitly prohibiting a stronger warning. Defendant’s unsupported hypothesis that the FDA saw the new warning as harmful seems among the least likely explanations, as the rejected proposal would not have eliminated IV push as an option for administering Phenergan.’ With respect to IV administration, the original label read, “When administering any irritant drug intravenously it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily,” while the proposed label stated, “[i]njection through a properly running intravenous infusion may enhance the possibility of detecting arterial placement. In addition, this results in delivery of a lower concentration of any arteriolar irritant.” See supra 4 n. | (comparing proposed and original warnings). Simply stated, the proposed warning was different, but not stronger. It was 2. The dissent appears to interpret any warning that would eliminate IV-push administration as inherently inconsistent with the FDA's approval of Phenergan for |V administration in general. We see no such inconsistency, as an approval of a drug for IV administration is not the same as a conclusion that all methods of IV administration are safe. In any case, a jury verdict in a failure-to- warn case simply establishes that the relevant warning was insufficient; it does not mandate a particular replacment warning. There may have been any number of ways for defendant to strengthen the Phenergan warning without completcly eliminating I1V-push adininistration. Our purpose in pointing out that the proposed warning the FDA rejected did not eliminate IV push is simply that rejecting this warning could not be seen as an affirmative effort by the FDA to preserve IV push as an option. 19a Appendix A also no longer or more prominent than the original warning, so it could not have raised a concern that it might overshadow other warnings on the label or drive doctors away from prescribing the drug. There is no evidence that the FDA intended to prohibit defendant from strengthening the Phenergan \abel pursuant to 4 314.70(c).’ Thus, we cannot conclude that it was impossible for defendant to comply with its obligations under both state and federal law. D. Obstacle to Congressional Purposes and Objectives Defendant next contends that state common-law liability for its use of an FDA-approved label presents an obstacle to federal objectives. We hold that plaintiff's claim does not interfere with any objective that can legitimately be ascribed to Congress. We agree with the reasoning in the cases cited above, supra 14-15, that federal labeling requirements pursuant to the FDCA create a floor, not a ceiling, for state regulation. Defendant presents a new FDA rule containing language disputing this reasoning, but this statement does not alter our conclusion that there is no conflict between federal objectives and Vermont common law. 3. We also reject defendant's argument that it would have been prosecuted for “misbranding” if it had strengthened the label without prior approval. See Witczak, 377 F.Supp.2d at 731, 729 (“[T]he validity and authority of state law ... does not depend on speculative hypotheticals” regarding “assumptions of what the FDA would have done™ in response to a stronger warning. ). 20a Appendix A 1. The Purposes and Objectives of Congress In the absence of a conflict that makes it impossible for a regulated entity to comply with both state and federal law, federal law will preempt state law only if it “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Freightliner, 514 U.S. at 287 (quotations omitted). We must therefore examine what “the full purposes and objectives of Congress” were with respect to federal labeling requirements for prescription drugs. We agree with the McNellis court that a system under which “federal regulations merely set minimum standards with which manufacturers must comply” is fully consistent with Congress’ primary goal in enacting the FDCA, which is “to protect consumers from dangerous products,” United States v. Sullivan, 332 U.S. 089, 696, 68 S.Ct. 331, 92 L.Ed. 297 (1948), as well as Congress’ stated intent that the FDCA “‘must not weaken the existing laws,’ but on the contrary ‘it must strengthen and extend that law’s protection of the consumer.’” United States v. Dotterweich, 320 U.S. 277[, 282] (1943) [quoting S.Rep. No. 152, 75th Cong., Ist Sess., p. |]. 2005 WL 3752269, at *7; see also Witczak, 377 F.Supp.2d at 731 (“Congress certainly did not intend to bar drug companies from protecting the public when enacting the FDCA; its goal was to protect the public.... Any contrary interpretation of Congress's intent is perverse.”). a4 2la Appendix A In fact, Congress has expressed its purposes clearly, not only in the general sense that the statute was intended to “protect the public,” but also more specifically, with respect to the FDCA’s preemptive effect. In the 1962 amendments to the FDCA, Congress included a clause expressly limiting the preemptive effect of the statute: “Nothing in the amendments made by this Act to the Federal Food, Drug. and Cosmetic Act shall be construed as invalidating any provision of State law ... unless there 1s a direct and positive conflict between such amendments and such provision of State law.” Drug Amendments of 1962 (Harris Kefauver Act), Pub.L. No. 87 781, 4 202, 76 Stat. 780, 793 (1962). This amendment essentially removes from our consideration the question of whether common-law tort claims present aa obstacle to the purposes and objectives of Congress. Congress intended that the FDCA would leave state law in piace except where it created a “direct and positive conflict” between state and federal law. Drug Amendments 4 202. This language “simply restates the principle that state law is superseded in cases of an actual conflict with federal law such that ‘compliance with both federal and state regulations is a physical impossibility.”” See S. Blasting Servs., Inc. v. Wilkes County, 288 F.3d 584, 591 (4th Cir.2002) (interpreting “direct and positive conflict” language in the preemption clause of a federal statute governing explosive materials to allow states to “impose more stringent requirements than those contained in the federal regulations”) (quoting Hillshorough County v. Automated Med. Labs., Inc., 471 U.S. 707, 713, 105 S.Ct. 22a Appendix A 2371, 85 L.Ed.2d 714 (1985)).* In other words, under any circumstances where it is possible to comply with both state law and the FDCA, the state law in question is consistent with the purposes and objectives of Congress. Thus, our 4. The debate surrounding the amendment helps confirm that it was intended to preserve the right of states to regulate beyond the federal requirements of the FDCA. During the floor debate in the House, the subject of preemption arose several times. First, Congressman Smith of California expressed concern that the bill, as reported, contained “no language ... which says anything to the effect that this particular measure will not preempt all State food and drug laws,” and thus, might risk interfering with the efforts of some states to make their own, stricter regulations. 108 Cong. Rec. 21046 (1962) (“[I]t seems to me that if we are going to pass this law, someone ought to offer an amendment to make certain that the passage of this bill, which gives all of this power to the Department of Health, Education, and Welfare and the Food and Drug Administration, will not preempt any State laws”). Shortly thereafter, Congressman Harris of Arkansas, the primary House sponsor of the bill, offered his opinion that “there is nothing in this bill that in any way preempts the authority and prerogatives of the States.” /d. at 21047. Congressman Schenck of Ohio agreed, stating, “[m]Jany very helpful State laws are in effect; many such laws in some instances are even stronger than Federal laws for the protection of human health in the public interest.” /d. at 21056. Congressmen Schenck and Harris, despite insisting that the bill as written would not preempt stronger state laws, eventually supported the “direct and positive conflict” amendment, and Schenck reiterated that preemption should not apply in the “many instances where State laws in the area of food and drugs and health are even stronger than some of the Federal laws.” /d. at 21083. Neither the desirability of allowing states to regulate beyond the FDCA nor the intent of the amendment to protect such regulation from preemption was called into question during the debate. 23a Appendix A discussion above regarding defendant’s impossibility argument, supra 21-23, provides a complete answer to the question of preemption. We recognize that our dissenting colleague has reached the opposite conclusion. There is little to say, beyond what we have already said, except that we respectfully disagree with his analysis of the FDCA, the FDA’s regulations, and the specific context of this lawsuit. Numerous courts have concluded, over the course of decades, that the FDCA provides a floor, not a ceiling, for state regulation. See supra, 14-15. While the dissent cites favorably the minority view, we agree with the majority view. There is much to be said for the policy arguments employed by courts adopting this minority view, including the argument that permitting too much state activity in this area will make beneficial dmgs less available to consumers. Similarly, there is merit to the majority perspective that eliminating lawsuits like the one at issue here would leave consumers without recourse in the event the FDA cannot move quickly enough to require strengthened warnings when they are appropriate. Our view is that neither policy argument is relevant here. The plain language of the statute indicates that Congress did not intend to interfere with state prerogatives except where doing so is absolutely necessary, see supra, 25-27, and the plain language of the regulation makes such interference unnece *ary here, see supra, 12-13. This analysis is consistent with the constitutionally rooted presumption against preemption. To look more broadly at arguments relying on assumptions about safety and economic efficiency is to apply the opposite presumption-the presumption that Congress could not possibly have intendec' to allow states to intrude on what 24a Appendix A seers, intuitively, to be an area of federal expertise. It is weither our responsibility, nor that of the FDA, to question the policy judgments of Congress. The litigation at issue here does not pose a direct and positive conflict with federal law, and thus, there is no basis for federal preemption. 2. The FDA’s New Statement on Preemption Defendant, after oral argument in this case, cited a new FDA regulation that contains a statement relating to the preemptive cffect of the FDCA. The substance of the regulation changes certain aspects of labeling requirements for prescription drugs, but these changes are irrelevant to this appeal because the new rule did not take effect until June 2006. Food and Drug Administation, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, Supplementary Information, 71 F d.Reg. 3922, 3922 (Jan. 24, 2006). The rule’s “Supplementary Information” section, however, contains a broad statement regarding the preemption of state common- law failure-to-warn claims. /d. at 3933-36. In this statement, the FDA asserts that recent cases rejecting preemption of these claims, including those cited above, pose an obstacle to the agency’s enforcement of the labeling requirements. Id. Among the interpretations the agency claims are incorrect are: (1) those rejecting preemption on the basis of 4 314.70(c); and (2) those stating that federal labeling requirements are minimum standards and that “[s]tate law serves as an appropriate source of supplementary safety regulation for drugs by encouraging or requiring manufacturers to disseminate risk information beyond that required by FDA under the act.” /d. at 3934. 25a Appendix A We are ordinarily required to defer to an agency’s interpretation of a statute it administers. Chevron, U.S.A., Inc. v. Natural Res. Def. Council, 467 U.S. 837, 844, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984) (“We have long recognized that considerable weight should be accorded to an executive department’s construction of a statutory scheme it is entrusted to admuinister....”). Plaintiff, however, urges us noi to defer to the FDA's statement because it “was adopted without the requisite comment period” and “lack[s] the force of law.” Presumably, if we were to credit plaintiff's argument, we would owe the statement only the limited deference due to agency statements made outside the agency's rulemaking authority. See United States v. Mead Corp., 533 U.S. 218, 226-27, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001) (stating that Chevron deference applies only “when it appears that Congress delegated authority to the agency generally to make rules carrying the force of law, and that the agency interpretation claiming deference was promulgated in the exercise of that authority”). We need not decide this difficult question of administrative law, however, because we conclude that irrespective of the level of deference we might apply, the statement woul? not affect the outcome of this appeal. Under Chevron, deference to an agency’s interpretation is appropriate only when a statute is “silent or ambiguous with respect to the specific issue” the agency has considered; otherwise, “the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress.” $67 U.S. at 842-43. Moreover, “[t}he judiciary is the final authority on issues of statutory construction and must reject administrative constructions which are contrary to clear / 26a Appendix A congressional intent.” /d. at 843 n. 9. “If a court, employing traditional tools of statutory construction, ascertains that Congress had an intention on the precise question at issue, that intention is the law and must be given effect.” Jd. When an agency's interpretation is not the type of interpretation entitled to Chevron deference, we must still grant it some respect, but only “a respect proportional to its ‘power to persuade.’” Mead, 533 U.S. at 235 (quoting Skidmore v. Swift & Co., 323 U.S. 134, 140, 65 S.Ct. 161, 89 L.Ed. 124 (1944)). Under either standard, the FDA’s statement deserves no defereuce. We have already concluded, supra 26-27, that Congress intended the FDCA to preempt only those state laws that would make it impossible for manufacturers to comply with both federal and state requirements. Nothing in the FDA’s new statement alters our conclusion that it would be possible for defendant to comply with both its federal obligations and the obligations of state common law. The regulatory framework for prescription drug labeling allows drug manzfacturers to add or strengthen a warning “to increase the safe use of the drug product” without prior FDA approval. See supra 10-13 (citing 21 C.F.R. { 314.70(c)(6)(iti)(C)). Even if the new rule eliminated or altered this provision, the change in the regulation did not take effect until June 2006.° Without such a change, it is possible for manufacturers to comply with beth FDA regulations and duties imposed by state common law, and there is no “direct and positive conflict” between state and federal law. 5. The only alteration the new rule appears to make to © 314.70 is that changes to the new “Highlights” section of a drug labe! may not be made without prior approval. 71 Fed.Reg. at 3934. 27a Appendix A The FDA does not attempt to establish such a conflict or explain the inconsistency between its position and the language of the preemption amendment. The statement cites the amendment, but then proceeds as if Congress had not spoken on the issue of preemption. The agency relies on Geter to support its disregard of Congress’s “direct and positive conflict” language, asserting that “[t]he existence of a legislative provision addressing pre-emption does not bar the operation ofordinary principles of implied preemption.” 71 Fed.Reg. at 3935 (citing Geier, 529 U.S. at 869). Geier does state that implied preemption applies even when a statute addresses preemption expressly, 521 U.S. at 869, but it does not allow courts or agencies to preempt state laws that have been expressly preserved by Congress. Instead, it simply stands for the proposition that Congress’s intent not to preempt a provision of state law cannot be inferred from either (1) an express preemption clause that does not include the state law in question in its scope, or (2) a clause that prevents regulated entities from using compliance with federal law as a defense in state common-law suits. /d. at 869-70. According to Geier, the former clause does not support a negative inference that Congress must have intended to preserve laws it did not expressly preempt; the latter indicates only that Congress intended to preserve some common-law claims, not that it intended to allow even claims that conflict with federal requirements. /d. But see id. at 870 (stating that even the latter clause would “preserve [ ] those actions that seek to establish greater safety than the minimum safety achieved by a federal regulation intended to provide a floor’). 28a Appendix A Here, we are not attempting to infer the effect of statutory language that only indirectly addresses the specific state law at issue. Instead, we are interpreting an unambiguous express preemption clause that specifically preserves the type of state law at issue. Under these circumstances, ordinary preemption principles must give way to Congress’s intent to preserve state laws that do not create a “direct and positive conflict” with federal law. Drug Amendments §| 202. There is no such conflict here. Accordingly, the FDA’s statement is neither an authoritative interpretation of an ambiguous statutory provision entitled to deference, Chevron, 467 U.S. at 842- 43, nor * persuasive policy statement entitled to respect. Mead, 533 U.S. at 235. Plaintiff's claim does not impose conflicting obligations on defendant or present an obstacle to the objectives of Congress. We therefore agree with the trial court that the claim is not preempted by federal law. Il. Apportionment of Damages Defendant next contends the court erred by ‘ailing to instruct the jury to reduce plaintiff's damages by che’amount of fault attributable to the Health Center. “Reversing a jury verdict based on allegedly faulty jury instructions is warranted where the party claiming error establishes that the instructions were erroneous and prejudicial.” Simpson v. Rood, 2005 VT 21, 5, 178 Vt. 474, 872 A.2d 306 (mem.). We hold that there was no error in the court's failure to require apportionment of damages between defendant and the Health Center. Defendant argues that pursuant to Vermont's comparative negligence statute, a defendant is liable for only the portion of the plaintiffs damages attributable directly to that _— 29a Appendix A defendant’s negligence. 12 V.S.A. | 1036. Our traditional rule is that multiple tortfeasors are jointly and severally liable. See Zaleskie v. Joyce, 133 Vt. 150, 158, 333 A.2d 110, 115 (1975) (“[T]he law of this state ... permits a plaintiff to pursue all, or any part, of his recovery from either joint tortfeasor’). According to defendant, § 1036 applies not only under circumstances where comparative negligence is alleged on the part of the plaintiff, and not only when multiple defendants are sued in the same action, but also any time the plaintiff recovers from someone besides the defendant. Thus, because plaintiff and the Health Center reached a settlement in a separate lawsuit related to the same injury, defendant claims the jury should have been required to calculate the Health Center’s proportion of causal negligence and subtract that percentage from the verdict. Section 1036 states, under the heading of “Comparative negligence,” Contributory negligence shall not bar recovery in an action by any plaintiff, or his legal representative, to recover damages for negligence resulting in death, personal injury or property damage, if the negligence was not greater than the causal total negligence of the defendant or defendants, but the damage shall be diminished by general verdict in proportion to the amount of negligence attributed to the plaintiff. Where recovery is allowed against more than one defendant, each defendant shall be liable for that proportion of the total dollar amount awarded as damages in the ratio of the amount of his causal 30a Appendix A negligence to the amount of causal negligence attributed to all defendants against whom recovery is allowed. 12 V.S.A. 4 1036. We interpreted this statute under slightly different circumstances in Plante v. Johnson, 152 Vt. 270, 565 A.2d 1346 (1989). In Plante, the defendant resisted joinder of the plaintiffs’ claims against her and a third party, resulting in a joint trial with two separate verdicts. The jury first returned a verdict against the third party for the entire amount of the plaintiff's damages, then found against the defendant for the same amount, and the court consolidated the judgments. The defendant appealed, arguing that the first verdict made the third party’s share of the fault 100%. She concluded that under 4 1036, she was entitled to a ruling apportioning 100% of the liability for the plaintiff's damages to the third party. The defendant failed to argue this point at trial, making a holding regarding 4 1036 unnecessary. We nevertheless examined the statute in depth to demonstrate that our determination that the defendant was not entitled to apportionment was “more than a technical omission.” /d. at 272, 565 A.2d at 1347. We concluded that the statute did not apply to the defendant in Plante because “the statute provides for apportionment among defendants, suggesting that only those joined in the same action should be considered in apportioning damages,” and “there is no allegation that the plaintiff was negligent in this case.” /d. at 273, 565 A.2d at 1347-48. 6. We also listed as an additional reason, not applicable here, that the third party whose liability was at issue in Plante was held liable under a different theory of liability that was not clearly within the scope of 1036. Id. at 273, 565 A.2d at 1348. 3la Appendix A In reaching this conclusion, we relied in part on the fact that “the New Hampshire Supreme Court has held that its nearly identical statute does not apply to create several liability in the absence of an allegation of negligence on the part of the plaintiff.” /d., 565 A.2d at 1348 (citing Lavoie v. Hollinracke, 127 N.H. 764, 513 A.2d 316, 319-20 (N.H.1986)). Defendant points out that Lavoie has since been overruled, but the decision overruling it, Nilsson v. Bierman, 150 N.H. 393, 839 A.2d 25 (N.H.2003), relied on a legislative revision of New Hampshire’s statute that placed the concepts of comparative negligence and apportionment under separate headings. /d. at 29. In the absence of action by the Legislature to amend Vermont's comparative negligence statute, we see no reason to depart from the interpretation of 4 1036 contained in Plante. The Health Center was not a party to plaintiff's action against defendant, and defendant does not allege that plaintiff was comparatively negligent, so 4 1036 ‘does not apply in this case. Defendant argues that whether or not 4 1036 applies, we can depart from our common law and determine that joint and several liability should no longer prevent apportionment among joint tortfeasors when one tortfeasor has settled in a previous action. We decline to do so. In Howard v. Spafford, 132 Vt. 434, 321 A.2d 74 (1974), which also involved an interpretation of 4 1036, we expressed our hesitation to depart from the rule precluding contribution among joint tortfeasors, preferring not to “substitute judicial fiat for legislative action.” /d. at 435, 321 A.2d at 75. Among the many reasons cited in Howard for adhering to the common law was the sheer number of alternative schemes adopted by other states. Id. at 436-37, 321 A.2d at 75-76. This reasoning applies here 32a Appendix A as well. Our choice is not between the traditional rule and a uniform new rule, but rather between a traditional rule and a number of potential new rules or combinations of rules. The Nilsson court pointed out the divide among states requiring jury verdicts to be reduced by the dollar amount of the plaintiff's settlement with a third party (pro tanto), those requiring verdicts to be reduced by the percentage of the settling party's fault (proportional share), and those requiring verdicts to be divided among all joint tortfeasors equally (pro rata). 839 A.2d 30-31. That court pointed out that while “[t}he American Law Instituie favors the proportional share approach ..., the overwhelming majority of States reject the proportional share approach in favor of some version of the pro tanto approach,” and New Hampshire’s legislature chose a combination of the two. Id. at 31 (citations and quotations omitted). It is important to note that if we were to adopt the majority rule, our decision would have no effect on this case, as plaintiff and defendant have stipulated to a pro tanto reduction. Like the New Hampshire court, we will allow the Legislature to determine which approach is best, if it has not done so already by leaving 4 1036 in place after our interpretation in Plante. Ill. Present Value of Damages Finally, defendant contends the court erred by failing to instruct the jury to calculate the present vale of plaintiff's damages for future non-economic losses, such as pain and suffering. Defendant claims that the jury’s verdict, which granted plaintiff $5 million in non-economic damages, exceeded the present value of plaintiff's requested amount by $856,073. In rejecting defendant's proposed instruction, 33a Appendix A the court pointed out that defendant failed to provide the jury with expert guidance as to how present value should be calculated, and that “[j]udges and lawyers are universally incapable of performing the discount calculations with or without a calculator and the tables of historic interest rates and inflationary factors.” We agree that it would have been inappropriate to instruct the jury to make such a calculation under these circumstances. Even if defendant had presented testimony allowing the jury to make an informed calculation, we would have upheld the jury’s verdict for several reasons. First, defendant’s assertion that the jury did not take account of the present value of plaintiff's non-economic damages is pure speculation, as plaintiff's calculation of her economic damages was presented in terms of its present value, and “the jury was not required to demonstrate its calculations” with respect to plaintiff's non-economic damages. Debus v. Grand Union Stores of Vt., 159 Vt. 537, 543, 621 A.2d 1288, 1292 (1993). Second, we limit pre-judgment interest to economic damages because non-economic damages are “inchoate and rarely ascertainable at the time of injury.” Turcotte v. Estate of LaRose, 153 Vt. 196, 200 n. 2, 569 A.2d 1086, 1088 n. 2 (1989). These damages become no less inchoate following a judgment, and we will not require juries to apply a precise economic calculation to a figure we have identified as inherently imprecise. Finally, most jurisdictions and the Restatement (Second) of Torts reject the concept of requiring juries to make present- value calculations with respect to non-economic damages. See, e.g., Tavior v. Denver & Rio Grande W. R.R., 438 F.2d 34a Appendix A 351, 353 (10th Cir. 1971) (holding that instruction requiring present-value reduction for pain and suffering was crror and stating that most courts that have considered the issue have decided “that the better reasoned authority supports the rule that future pain and suffering should not be reduced to current worth”); Restatement (Second) of Torts 4 913A cmt. a(1979) (stating that while future pecuniary losses should be reduced to present value, “an award for future pain and suffering or for emotional distress is not discounted in this fashion’’). But see Olivieri v. Delta S.S. Lines, Inc., 849 F.2d 742, 750- 51 (2d Cir.1988) (stating that “[i]f we were writing on a clean slate, we might be inclined to accept the view of the other circuits and reject any discounting of future non pecuniary losses,” but previous Second Circuit holdings required such discounting in some form). Defendant's reliance on our decision in Parker v. Roberts, 99 Vt. 219, 131 A.2d21 (1925), is misplaced, as Parker, while it required a jury instruction on the present value of future losses, did not address the distinction between pecuniary and non-pecuniary losses. /d. at 224-25, 131 A. 21, 131 A.2d at 23. The trial court did not err in refusing to instruct the jury to reduce plaintiffs non- economic damages to present value. Affirmed. Associate Justice 35a Appendix A Dissenting REIBER, C.J., dissenting. The overarching issue in this appeal is whether plaintiff's common-law claim for failure to warn conflicts with the FDA’s regulation of Phenergan, the drug responsible for plaintiff's injuries. I would conclude that the jury’s verdict in this case conflicts with federal law for two reasons. First, it would be impossible for defendant Wyeth to comply with the requirements of both state and federal law. Specifically, the FDA approved IV administration of Phenergan and required that IV administration be listed on the Phenergan label. By contrast, plaintiff's theory of the case required Wyeth either to remove this approved use from the Phenergan label, add a warning that would directly contradict the label’s indication that [V administration was a safe and effective use, or, at a minimum, add a warning that only certain types of IV administration should be used. Thus, compliance with state law in this case would require Wyeth to eliminate uses of Phenergan approved by the FDA and required to be included in the Phenergan labeling. Second, plaintiff's state-law claim conflicts with federal law in that it poses an obstacle to federal purposes and objectives. In short, by approving Phenergan for marketing and distribution, the FDA concluded that the drug-with its approved methods of administration and as labelea-was both safe and effective. See 21 U.S.C.;9 355(d) (listing criteria for drug approval). In finding defendant liable for failure to warn, a Vermont jury concluded that the same drig-with its approved methods of administration and as labeled-was “unreasonably dangerous.” See Town of Bridport v. Sterling 36a Appendix A Clark Lurton Corp., 166 Vt. 304, 308, 693 A.2d 701, 704 (1997) (to succeed on failure-to-warn claim, plaintiff must show that “failure to warn made the product unreasonably dangerous and therefore defective”). These two conclusions are in direct conflict. For both of these reasons I would conclude that the state- law cause of action is preempted. I respectfully dissent. 1. Impossibility of Compliance As explained by the majority, because there is no clause in the FDCA expressly preempting state law, Wyeth must demonstrate that preemption is implied by showing either that federal law thoroughly occupies the regulatory field (a claim that Wyeth does not advance) or that there is an actual conflict between state and federal law. Actual conflict, in turn, can be demonstrated in one of two ways: by showing that it 1s impossible for the regulated party to comply with both state and federal law or that state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995) (quotations omitted). The majority in essence concludes that it is not impossible for Wyeth to comply with both federal and state standards because Wyeth never sought FDA approvai of a “stronger warning” ofthe type advocated by plaintiff. According to the majority, because the FDA was not presented with, and therefore did not explicitly reject, such strengthened language, there 1s no reason to presume that 37a Appendix A the FDA would disapprove. Therefore, the majority reasons, there 1s no actual conflict between state and federal law. See ante § 21-22. It is inaccurate, however, to characterize the requirements imposed by the jury verdict in this case as merely requiring a “stronger warning.” Rather, what plaintiff sought was an elimination of a use of Phenergan that had been approved by the FDA. Furthermore, the FDA’s rejection of Wyeth’s efforts to alter the language of the warning in 2000 supports Wyeth’s claim that the FDA had an affirmative preference for the language of the original warning. A. The crux of plaintiff's claim was not based on the label warnings per se, but on the approved uses listed there. See, e.g., ante ¥ 3 (“Plaintiff's experts testified that the label should not have allowed IV push as a means of administration....”"). A review of plaintiff's complaint and the evidence presented at trial makes clear that the standard plaintiff seught to establish (i.e., the change to the label that would be required in light of the jury’s finding of liability) was to remove IV administration-or at least certain types-as an approved use. For example, plaintiit’s complaint asserted that the warnings on the label were inadequate and that: [t]he Phenergan sold by defendant is ... NOT REASONABLY SAFE FOR INTRAVENOUS ADMINISTRATION because the foreseeab!c risks of harm posed by intravenous administration of the drug are sufficiently great in relation to its foreseeable theraputic benefits that reasonable health care providers, knowing of such foreseeable 38a Appendix A risks and benefits, WOULD NOT PRESCRIBE THE DRUG INTRAVENOUSLY FOR ANY CLASS OF PATIENTS.” (Emphasis added.) !n her appellate brief, p [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0529%3A02. Public record. Not legal advice.