Warning, This Decision Will Increase the Cost ofPrescription Drugs: How the Supreme Court’sMisapplication of Preemption Doctrine in Wyeth V. LevinePortends Devastating Consequences for Oklahoma
Critics called it a “major setback for business groups”1 and a “cure worse
than gangrene.”2 Supporters said it was a “great day for . . . our Constitution.”3The Wall Street Journal opined that it was “the mother of all preemptioncases.”4 “It” is Wyeth v. Levine, perhaps the most important and hotly debatedpreemption case ever decided by the United States Supreme Court.5 In Wyeth,the plaintiff, Diana Levine, brought an action under Vermont state law againstdrug manufacturer Wyeth Pharmaceuticals for failing to warn of dangersregarding the administration of the nausea medication Phenergan directly intoa patient’s vein.6 Wyeth defended on the grounds that Food and DrugAdministration (FDA) labeling regulations preempted Levine’s claims.7Wyeth argued that it would have proved impossible to adhere to a state lawduty to modify Phenergan’s warning label without violating federal law, andthat judicial recognition of such state law claims would impede the objectivesof Congress and the FDA in creating federal labeling regulations.8 Findingfor Levine, the Supreme Court held that FDA labeling requirements did notpreempt the state law claims against Wyeth.9 The Court found that Wyeth
1. Adam Liptak, No Legal Shield in Drug Labeling, Justices Rule, N.Y. TIMES, March 5,
2009, at A1, available at http://nytimes.com/2009/03/05/washington/05scotus.html.
2. Jim Copeland & Paul Howard, Op-Ed., Copeland/Howard: A ‘Cure’ Worse ThanGangrene, WASH. TIMES, March 9, 2009, available at http://www.washingtontimes.com/news/2009/mar/09/a-cure-worse-than-gangrene//print/.
3. Press Release, Doug Kendall, President of Constitutional Accountability Ctr., Statement
on Today’s Supreme Court Ruling in Wyeth v. Levine (March 4, 2009), available at http://www.theusconstitution.org/page_module.php?id=28&mid=15.
4. Wyeth v. Levine: The Mother of All Preemption Cases, WALL ST. J. HEALTH BLOG
(Sept. 19, 2008, 8:21 AM), http://blogs.wsj.com/health/2008/09/19/wyeth-v-levine-the-mother-of-all-preemption-cases/.
5. 129 S. Ct. 1187 (2009). 6. Id. at 1191-92. 7. Seeid. at 1193. 8. Id. 9. Id. at 1204.
could have complied with Vermont failure-to-warn law without violating itsobligations under FDA regulations,10 that Vermont’s failure-to-warn laws didnot obstruct the purposes and objectives of FDA drug labeling requirements,11and that the preamble to the 2006 FDA regulations—which asserted that statelaws contrary to the regulations were preempted—did not merit deference.12
This note contends that the decision in Wyeth v. Levine is incorrect. The
Supreme Court abandoned precedent by misapplying preemption doctrine. The Court erroneously applied the presumption against preemption, and itsreasoning deviated drastically from prior case law. What is more, the Courtignored important economic and public policy considerations—namely, howsubjecting pharmaceutical companies to liability under state failure-to-warnlaws, despite their compliance with FDA labeling regulations, has the potentialto dramatically increase prescription drug prices, which would proveespecially troublesome for Oklahoma given its population demographics.
Part II of this note discusses the law before Wyeth, focusing on the FDA’s
regulatory framework for prescription drug labeling, evolution of thepreemption doctrine, modern application of preemption doctrine by theSupreme Court, and Oklahoma’s treatment of FDA labeling requirements vis-à-vis state law failure-to-warn claims. Part III provides an in-depth overviewof the Supreme Court’s decision in Wyeth v. Levine, highlighting the facts ofthe case, Justice Stevens’ majority opinion, and Justice Alito’s dissent. PartIV analyzes the Court’s holding in Wyeth. Specifically, Part IV argues that theCourt wrongly utilized the presumption against preemption, erroneously failedto conclude that state failure-to-warn claims upset the purposes and objectivesof FDA drug regulations and thus are preempted by the doctrine of conflictpreemption, and constructed an opinion that is inconsistent with its priordecision in Geier v. American Honda Motor Co, Inc. Part V explains howWyeth is likely to cause a considerable increase in prescription drug prices andhow such an increase would be exceedingly harmful to Oklahoma. Part V alsooutlines Wyeth’s impact on Oklahoma tort practitioners, positing that the casewill boost lawsuits against pharmaceutical companies premised on failure-to-warn theories, enhancing the Oklahoma tort bar’s business. This noteconcludes in Part VI.
10. Seeid. at 1200-01. 11. Seeid. at 1199. 12. Seeid. at 1201-02. A. FDA Regulation of Prescription Drug Labeling
The modern version of the FDA’s regulatory scheme for prescription drug
labeling originated with enactment of the Food, Drug, and Cosmetic Act of1938 (FDCA), which was adopted by Congress to protect the public health andstop the sale of misbranded or adulterated drugs through enforcement ofstandards mandating purity and effectiveness.13 Congress has expanded theFDCA over the past six decades and the primary regulation governingprescription drug labeling today is the New Drug Approval Process. Thisstandard requires labels to contain the name of the drug and the manufacturer’splace of business, “adequate directions for use, adequate warnings againstdangerous use, and sufficient warnings against unsafe dosage.”14 In 2006, theFDA announced additional requirements for prescription drug labeling underthe New Drug Approval process, which apply to all drugs approved after2001.15 The 2006 requirements introduced three changes: (1) addition of a“Highlights” section, which provides ready access to a drug’s “mostcommonly referenced material;”16 (2) reorganization of the graphical contentsof labeling;17 and (3) increased accessibility of warning and adverse reactioninformation.18
The FDA has described the New Drug Approval Process as “one of give-
and-take with oversight by the FDA.”19 Under the New Drug ApprovalProcess, the FDA approves proposed labeling following review of anapplication submitted to the FDA by the drug manufacturer.20 The FDAinvestigates evidence submitted by the manufacturer, as well as other relevantinformation,21 and the drug manufacturer and the FDA typically discuss theproposed labeling in detail, particularly as it relates to the warnings to beincluded.22 Based on known scientific evidence, the FDA and the
13. Mary J. Davis, The Battle Over Implied Preemption: Products Liability and the FDA,
48 B.C. L. REV. 1089, 1100 (2007) (outlining requirements of the federal food and drug laws).
14. Seeid. at 1101-02. 15. Seeid. at 1106. 16. Id. 17. Seeid. 18. Seeid. 19. Seeid. at 1105. 20. Seeid. at 1104. 21. Id. (citing Brief for United States as Amicus Curiae Supporting Defendant-Appellant
at 5, Motus v. Pfizer Inc., 358 F.3d 659 (2004)(no. 02-55372), 2002 WL 32303084)(noting thatthe FDA does not explain what it means by “other relevant information”).
manufacturer then formulate labeling incorporating the appropriate warningswhile attempting to avoid any statement of unsubstantiated risks that coulddeter use of the drug.23 In the event that a pharmaceutical company does notcomplete the New Drug Approval process as outlined, the FDA can designatethe drug misbranded and assess severe penalties against the company forselling it, including seizure of the drug from the market.24
The FDA has also established a process whereby drug manufacturers, in
specific circumstances, can change existing labels to reflect newly acquiredinformation without having to await approval of another application under theNew Drug Approval process.25 The “changes being effected” regulationprovides that the holder of an approved application may commencedistribution of the drug that is the subject of the proposed labeling changeupon receipt by the FDA of a supplemental application if the proposed changeis to, among other things, “add or strengthen a contraindication, warning,precaution, or adverse reaction.”26
B. Evolution of Preemption Doctrine
Preemption doctrine derives from the Supremacy Clause, found in Article
IV of the United States Constitution.27 The Supremacy Clause states:
This Constitution, and the laws of the United States which shall bemade in pursuance thereof; and all treaties made, or which shall bemade, under the authority of the United States, shall be the supremelaw of the land; and the judges in every State shall be boundthereby, any Thing in the Constitution or the laws of any State tothe contrary notwithstanding.28
Despite the Supremacy Clause’s command for broad federal authority, theSupreme Court has traditionally proved reluctant to find federal preemptionof state laws due to respect for state sovereignty in our federalist system.29
23. Seeid. at 1104-05. 24. Seeid. at 1101-02. 25. Seeid. at 1105. 26. See 21 C.F.R. § 314.70(c)(6)(iii)(A) (2008). The “changes being effected” regulation
is particularly significant because it served as one basis for the Wyeth court’s conclusion thatFDA drug labeling regulations did not preempt Levine’s state law action. See Wyeth v. Levine,129 S. Ct. 1187, 1197 (2009).
27. See Donald T. Bogan, Protecting Patient Rights Despite ERISA: Will the SupremeCourt Allow States to Regulated Managed Care? 74 TUL. L. REV. 951, 960 (2000) (describingpreemption analysis).
28. U.S. CONST. art. VI, cl. 2 (second emphasis added). 29. See Bogan, supra note 27, at 961.
Therefore, there is a presumption against preemption.30 Courts will givefederal law preemptive effect only when Congress displays a clear desire forpreemption.31
The Court enumerated three categories of preemption in Savage v. Jones.32
The first category is “express preemption, where Congress explicitly definesthe extent to which its enactments preempt state law.”33 The second categoryis field preemption.34 Field preemption occurs when “state law attempts toregulate . . . a field that Congress intended the federal law exclusively tooccupy.”35 The final category of preemption is conflict preemption.36 Conflictpreemption arises when “it is impossible to comply with both state and federalrequirements, or where state law stands as an obstacle to the accomplishmentand execution of” Congress’s purposes and objectives.37
C. Modern Application of Preemption Doctrine by the Supreme Court1. Geier v. American Honda Motor Co.
In the 2000 case of Geier v. American Honda Motor Co., the Supreme
Court considered a lawsuit brought by an injured motorist against anautomobile manufacturer under District of Columbia tort law.38 The motoristargued that the manufacturer was negligent because it failed to design adriver’s side airbag in her vehicle, a 1987 Honda Accord.39 In 1984, however,the Department of Transportation (DOT), “under the authority of the NationalTraffic and Motor Vehicle Safety Act of 1966,” had announced a FederalMotor Vehicle Safety Standard (FMVSS) “requiring auto manufacturers toequip some but not all of their 1987 vehicles with passive restraints,40 whichincluded airbags and automatic seatbelts.41 The Court thus had to decidewhether the safety standard issued by the DOT, which did not require
30. See Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947) (“Congress legislated
here in field which the States have traditionally occupied. So we start with the assumption thatthe historic police powers of the States were not to be superseded by the Federal Act. . . .”).
31. See Retail Clerks Int’l Ass’n, Local 1625 v. Schermerhorn, 375 U.S. 96, 103 (1963)
(noting that “[t]he purpose of Congress is the ultimate touchstone” in every preemption case).
32. See 225 U.S. 501 (1912) (holding that state law requiring manufacturer of medicinal
feed to disclose ingredients was not preempted by federal law).
33. Indus. Truck Ass’n v. Henry, 125 F.3d 1305, 1309 (9th Cir. 1997). 34. Seeid. 35. Id. 36. Seeid. 37. Id. 38. 529 U.S. 861, 865 (2000). 39. Seeid. at 865. 40. Id. at 864-65. 41. Seeid. at 878.
automobile manufacturers to include airbags in all 1987 cars, preempted themotorist’s state common-law tort claim.42
In a 5-4 decision,43 the Court held that the 1984 FMVSS preempted the state
law claim under the category of conflict preemption.44 Writing for the Court,Justice Breyer found that the DOT had made clear its desire not to requireinclusion of airbags in every 1987 automobile.45 Rather, the DOT haddetermined that it could best promote safety by allowing manufacturers tochoose from a range of different restraint devices (e.g., automatic seatbelts andignition interlock devices, as well as airbags).46 The Court found thatdetermination to be premised on several significant considerations, such as thebelief that airbags could not make up for all of the dangers caused byunbuckled seatbelts, the intrusiveness of and public dislike for seatbelts andairbags, the danger that airbags pose to children and other out-of-positionoccupants in small cars, and the high cost of airbags compared to otherrestraint devices.47 Because the motorist’s state law action depended on afinding that the manufacturer was negligent in failing to install an airbag in themotorist’s 1987 vehicle, the action—if successful—would create a new dutyon automobile manufacturers who marketed their new vehicles in the Districtof Columbia to place airbags in all vehicles.48 Therefore, the state law action“stood ‘as an obstacle to the accomplishment’” of the DOT’s purposes andobjectives in formulating the 1984 FMVSS—to achieve safety by permittingmanufacturers to vary the types of restraint devices they placed in theirautomobiles.49
2. Buckman Co. v. Plaintiffs’ Legal Committee
A year after it decided Geier, the Supreme Court heard another high-profile
preemption case: Buckman Co. v. Plaintiffs’ Legal Committee.50 Buckmancentered on a state law fraud claim.51 The plaintiffs alleged to have sufferedinjuries from the implantation of orthopedic screws into their spines.52 Theplaintiffs contended that the consultant to the manufacturer of the screws had
42. Id. at 865. 43. Seeid. at 863. 44. Seeid. at 886. 45. Id. at 863, 875. 46. Seeid. at 875-76. 47. Seeid. at 877-78. 48. Seeid. at 881. 49. Id. at 881-82 (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). 50. 531 U.S. 341, 341 (2001). 51. Seeid. at 343. 52. Seeid.
obtained Food and Drug Administration (FDA) approval for the screwsthrough misrepresentations to the FDA.53
The Court unanimously54 concluded that “the Federal Food, Drug, and
Cosmetic Act (FDCA), as amended by the Medical Device Amendments of1976 (MDA),” preempted the plaintiffs’ state fraud claim.55 Like Geier, theCourt decided Buckman on conflict preemption grounds.56 The Court firststated that the presumption against preemption did not apply because“[p]olicing fraud against federal agencies is hardly a field which the Stateshave traditionally occupied.”57 The Court noted secondly that the federalstatutory scheme empowered “the FDA to punish and deter fraud against” itsagency and that the FDA used this authority “to achieve a somewhat delicatebalance of statutory objectives.”58 In the Court’s view, permitting “fraud-on-the-FDA claims” to proceed under state tort law would disrupt this balance.59The Court emphasized that mandatory compliance with the FDA’s regulatoryregime and the varying tort regimes of the fifty states would saddlemanufacturers of medical devices with much greater burdens than Congressintended in passing the MDA.60 The Court also stated its belief that enablingsimilar fraud claims to go forward would cause applicants to submit too muchinformation to the FDA—thereby slowing the approval process and, in turn,impeding competition among manufacturers of medical devices.61
D. Oklahoma’s Treatment of FDA Labeling Requirements and State LawTort Claims
Prior to the Supreme Court’s decision in Wyeth, a federal district court in
Oklahoma weighed in on the issue of whether FDA labeling regulationspreempt state law tort claims. In Dobbs v. Wyeth Pharmaceuticals, the UnitedStates District Court for the Western District of Oklahoma considered anaction brought by the plaintiff against the defendant, Wyeth Pharmaceuticals,alleging that the plaintiff’s husband had committed suicide as a consequenceof taking a prescription antidepressant drug manufactured by Wyeth.62 The
53. Seeid. 54. Seeid. at 342. 55. Id. at 344 (citations omitted). 56. Seeid. at 348. 57. Id. at 347 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947) (internal
58. Id. at 348. 59. Id. 60. Seeid. at 350. 61. Seeid. at 351. 62. Dobbs v. Wyeth Pharm., 530 F. Supp. 2d 1275, 1277 (W.D. Okla. 2008), vacated 606
plaintiff argued that the defendant was liable to her for damages underOklahoma common law because it had failed to adequately warn that the drugher husband took, Effexor, could lead to suicidal thoughts and feelings.63 Thedefendant filed a motion for partial summary judgment, arguing that FDAprescription-drug-labeling regulations preempted the plaintiff’s claims.64Specifically, the defendant claimed that the FDA had concluded that scientificevidence did not support attaching a warning of suicide to Effexor, andtherefore, it could not issue such a warning in order to comply with Oklahomalaw, without violating federal law.65 The plaintiff argued that the FDAregulations did not preempt Oklahoma law because the regulations permittedthe defendant to change its label to include the suicide warning without FDAapproval.66
The district court held that FDA prescription drug labeling regulations did
in fact preempt Oklahoma tort law under the category of conflict preemption.67 The court focused its attention on two issues: (1) the history of the FDA’sregulation of antidepressants, and (2) the FDA’s position on preemption, asreflected by the preamble to its 2006 regulations.68 Concerning the former, theDobbs court found that the FDA had conclusively determined that warningsabout the potential for suicide were unwarranted because scientific evidencedid not support a strong enough connection between use of antidepressants andsuicide.69 The court based this finding on the writings of the FDAPsychopharmacological Drugs Advisory Committee, which convened for theexpress purpose of studying the potential link between antidepressant use andsuicide, and had determined that no link existed.70 The court also based itsfinding on numerous amicus curiae briefs filed by the FDA in other failure-to-warn cases stating that evidence did not show consumption of antidepressantswas connected to suicide.71 Accordingly, a state law determination that sucha warning was necessary created a conflict “between federal and state law, andimpose[d] inconsistent federal and state obligations.”72
As to the FDA’s position on preemption, the Dobbs court afforded
significant weight to the FDA’s judgment in the 2006 preamble that state
63. Id at 1277. 64. Id. 65. Id. 66. Id. 67. Id. at 1279-80, 1289-91. 68. Seeid. at 1280, 1285-86. 69. Id. at 1283-84. 70. Seeid. at 1282-83. 71. Id. at 1282-84. 72. Id. at 1289-90.
failure-to-warn claims conflicted with FDA regulations.73 Citing ChevronUSA, Inc. v. Natural Resources Defense Council,74 the court rejected theplaintiff’s argument that the FDA’s change in position from 2000 (when theFDA stated on record that its regulations did not preempt state law failure-to-warn claims) meant the 2006 preamble was entitled to no deference.75Additionally, the Dobbs court was not persuaded by the conclusion of othercourts that the 2006 preamble was “contrary to the regulations’ imposition [on]drug manufacturers of a continuing duty to monitor the safety of their products. . . .”76 The court stressed that manufacturers could still change their labels toreflect previously unknown or new risks, as opposed to risks the FDA hadalready analyzed.77 Thus, the court found that the FDA’s position onpreemption, as reflected in the 2006 preamble, was reasonable, supported bylaw, and entitled to deference.78
On April 7, 2000, Diana Levine visited her local clinic to obtain treatment
for a migraine headache.79 Levine “received an intramuscular injection ofDemerol for her headache and Phenergan,” an antihistamine manufactured byWyeth Pharmaceuticals, for nausea.80 The treatment given to Levine did notprovide her relief, so she returned later the same day to receive a secondinjection of both Demerol and Phenergan.81 For Levine’s second injection, theattending physician administered the drugs via the “IV-push” method, inwhich “the drug is injected directly into a patient’s vein,” rather than first
73. Seeid. at 1289. In the 2006 preamble, the FDA stated “that state law claims concerning
drug labeling ‘conflict with and stand as an obstacle to the achievement of full objectives andpurposes of Federal law.’” Id. (quoting 71 Requirements on Content and Format of Labelingfor Human Prescription Drug and Biological Products, Fed. Reg. 3922, 3935 (Jan. 24, 2006) (tobe codified at 21 C.F.R. pts. 201, 314, 601)).
74. Dobbs, 530 F. Supp. 2d at 1288 (“The fact that an agency has from time to time
changed its interpretation . . . does not . . . lead us to conclude that no deference should beaccorded to the agency’s interpretation of the statute.”) (quoting Chevron USA Inc., v. NaturalRes. Def. Council, 467 U.S. 837, 863 (1984)).
75. Id. at 1287-88 (“Although the FDA’s position regarding preemption since 2000
conflicts with its prior view, the change in position does not require this Court to disregard theFDA’s current position.”).
76. Id. at 1289. 77. Id. 78. Seeid. At 1288-89. 79. Wyeth v. Levine, 129 S. Ct. 1187, 1191 (2009). 80. Id. 81. Id.
being introduced into a saline solution bag and delivered to the vein througha catheter, the more common “IV-drip” method.82 During the IV-pushinjection Phenergan escaped into Levine’s artery, where it encountered arterialblood.83 Consequently, Levine developed gangrene, forcing doctors toamputate her entire right forearm.84
Levine incurred substantial medical expenses, pain and suffering, and the
loss of her career as a professional musician, and she brought an action fordamages against Wyeth.85 Levine based her action on common law negligenceand strict liability theories, alleging that Phenergan’s warning label “wasdefective because it [did not] instruct clinicians to use the IV-drip method” infavor of the IV-push method.86 In response, Wyeth filed a motion forsummary judgment.87 Wyeth contended that federal law preempted Levine’sfailure-to-warn claims on conflict preemption grounds.88 The trial court foundno merit in Wyeth’s conflict preemption argument and the trial proceeded.89Evidence presented during trial showed that the use of the IV-drip method inplace of the IV-push method could virtually eliminate the risk of intra-arterialinjection.90 The record also contained “correspondence between Wyeth andthe FDA discussing Phenergan’s label.”91 “The FDA first approved injectablePhenergan in 1955. In 1973 and 1976, Wyeth submitted supplemental drugapplications, which [the FDA] approved after proposing labeling changes.”92In 1981, after the FDA promulgated new guidance regarding labeling, Wyethsubmitted a third supplemental application.93 Throughout the subsequentseventeen years, Wyeth corresponded with the FDA intermittently concerningPhenergan’s label.94 Notably, the FDA suggested different warnings relating
82. Id. 83. Id. 84. Id. 85. Id. 86. Id. at 1191-92. Phenergan’s warning label read, in pertinent part, as follows: “Due to
the close proximity of arteries and veins in the areas most commonly used for intravenousinjection, extreme care should be exercised to avoid perivascular extravasation or inadvertentintra-arterial injection. Reports compatible with inadvertent intra-arterial injection of PhenerganInjection, usually in conjunction with other drugs intended for intravenous use, suggest thatpain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiringamputation are likely under such circumstances.” Id. at 1191 n.1.
87. Id. at 1192. 88. Id. 89. Seeid. 90. Id. 91. Id. 92. Id. 93. Id. 94. Id.
to the risk of arterial exposure in 1987.95 In 1988, Wyeth submitted revisedlabeling containing the changes proposed by the FDA the previous year.96 TheFDA did not respond until 1996, when it told Wyeth to “[r]etain verbiage incurrent label.”97 In 1998, the FDA approved Wyeth’s 1981 supplementalapplication.98
At conclusion of the trial, the jury found Wyeth negligent and that
Phenergan was a defective product due to inadequate warnings.99 The juryawarded Levine damages amounting to $7,400,000.100 Wyeth filed a motionfor judgment as a matter of law.101 The trial court denied Wyeth’s motion,dismissing its conflict preemption arguments.102 The court found “no directconflict between FDA regulations and Levine’s state law claims” becauseFDA regulations permit a manufacturer to strengthen its warnings on aninterim basis without approval.103 The trial court also concluded that allowingLevine’s state law claims to go forward would not impede the FDA’s purposesand objectives, as “the agency had paid no more than passing attention to”whether Phenergan should include a warning against using the IV-pushmethod to administer the drug.104 The Vermont Supreme Court affirmed theruling of the trial court, holding “that the jury’s verdict did not conflict withthe FDA’s labeling requirements for Phenergan because Wyeth could havewarned against IV-push administration” in the absence of FDA approval.105Additionally, the Vermont Supreme Court held that “federal labelingrequirements create a floor, not a ceiling, for state regulation.”106
B. Justice Stevens’ Majority Opinion
In a 6-3 decision, the United States Supreme Court affirmed the opinion of
the Vermont Supreme Court, finding that FDA prescription drug labelingregulations did not preempt Diana Levine’s state failure-to-warn claimspertaining to Phenergan.107
95. Id. 96. Id. 97. Id. 98. Id. 99. Id. at 1193.
100. Id. 101. Id. 102. Id. 103. Id. 104. Id. 105. Id. 106. Id. 107. Wyeth v. Levine, 129 S. Ct. 1187, 1196-97 (2009). Justice Thomas filed an opinion
in which he concurred with the result reached by the majority but criticized the Court’s general
Regarding Wyeth’s contention that it was impossible to comply with both
state failure-to-warn requirements and its federal labeling duties,108 theCourt—agreeing with the trial court—found that the FDA’s “changes beingeffected” (CBE)109 regulation enabled Wyeth to change its label to complywith Vermont law without violating its obligations under the FDA labelingrequirements.110 The Court noted that, given the evidence presented showingat least twenty incidents prior to Levine’s injury in which IV-pushadministration of Phenergan resulted in gangrene and an amputation, Wyethcould have—and should have—updated Phenergan’s label to specifically warnagainst IV push administration of the drug on the basis that such evidence was“newly acquired information” under the CBE.111
Next, the Court rejected Wyeth’s contention “that requiring it to comply
with a state-law duty to provide a stronger warning about IV-pushadministration would obstruct the purposes and objectives of federal druglabeling” law and thereby trigger conflict preemption.112 The Court took noteof Congress’s decision to omit an express preemption provision from the FDAregulations, writing:
;If Congress thought state-law suits posed an obstacle to its objectives,it surely would have enacted an express preemption provision at somepoint during the FDCA’s [Food and Drug Cosmetic Act] 70-year history. But despite its 1976 enactment of an express preemption provision formedical devices, Congress has not enacted such a provision forprescription drugs.113The Court also dismissed Wyeth’s claim that the preamble to the 2006 FDA
regulations was entitled to preemptive force.114 The preamble read, in part,“The FDCA establishes both a ‘floor’ and a ‘ceiling’ . . . FDA approval oflabeling . . . preempts conflicting or contrary State law.”115 The Court listedthree reasons the preamble did not have preemptive effect.116 First, the Court
approach to preemption cases. Cf.id. at 1204-17 (Thomas, J., concurring). Justice Breyer fileda concurring opinion emphasizing what he viewed as the narrow application of the majorityopinion and cautioning against the potential economic effect of the majority opinion. Cf.id. at1204 (Breyer, J., concurring). For purposes of this note, the aforementioned opinions will notbe discussed further.
108. Id. at 1196 (majority opinion). 109. Id. 110. Seeid. at 1197. 111. Id. 1196-98. 112. Id. at 1199. 113. Id. at 1200. 114. Id. at 1203. 115. Id. at 1200. 116. Seeid. at 1201-03.
established that an agency regulation with the force of law could preemptconflicting state requirements.117 Rather than it being an agency regulationwith the force of law, the Court declared that the preamble was nothing morethan a mere assertion by the FDA.118 Second, the Court did not accord thepreamble preemptive effect because the FDA finalized it “without offeringstates or other interested parties notice or opportunity for comment.”119 TheCourt noted that the weight it accords to an agency’s explanation of a statelaw’s impact on the federal scheme depends on the explanation’sthoroughness, consistency, and persuasiveness, and that—in light of theprocedural failure committed by the FDA in failing to provide opportunity forcomment on the preamble—the agency’s views on state law were inherentlysuspect.120 Third, the Court found the preamble plainly incongruent with theFDA’s long-held position that federal labeling standards did not preempt statetort law.121 The Court highlighted the fact that, prior to Levine’s injury, theFDA had never so much as implied that state tort law was an obstacle toachievement of its goals.122 Rather, the FDA had always categorized federallabeling standards as a minimum threshold “upon which States could build.”123Wading into a policy argument, the Court outlined the Court’s belief that statelaw had traditionally complimented, not obstructed, federal law in the field ofprescription drug labeling by uncovering previously unknown drug hazardsand incentivizing prompt disclosure of safety risks by drug manufacturers.124
Finally, the Court distinguished the case at bar from Geier.125 In the
majority’s judgment, Geier was entirely distinct from the case before the Courtbecause the DOT in Geier had conducted formal rulemaking before adoptingits regulation; the FDA had not.126 Moreover, the FDA, unlike the DOT inGeier, had not engaged in a deliberative balancing of state law and federal
117. Id. at 1200. 118. Seeid. at 1200-01 (“This Court has recognized that an agency regulation with the force
of law can pre-empt conflicting state requirements. . . . We are faced with no such regulationin this case, but rather with an agency’s mere assertion that state law is an obstacle to achievingits statutory objectives.”).
119. Id. at 1201. 120. Id. 121. Id. at 1201-02. 122. Id. 123. Id. at 1202. 124. Id. 125. Seeid. at 1203 (“Wyeth and the dissent contend that the regulatory scheme in this case
is nearly identical [to Geier], but as we have described, it is quite different.”).
objectives in determining that state law was preempted.127 Therefore, therationale of Geier did not apply.128
Justice Alito disagreed sharply with the majority opinion of Justice Stevens,
filing a forceful dissent joined by Justices Roberts and Scalia.129 The dissentbegan by criticizing the majority’s emphasis on Congress’s failure to includean express preemption provision in the FDCA, stating that “the ordinaryprinciples of conflict pre-emption turn solely on whether a State has upset theregulatory balance struck by the federal agency.”130
The dissent next argued that the rationale employed in Geier applied to the
instant case.131 The dissent posited that the FDA’s oversight of Phenergan(spanning more than fifty years)132 and decision not to mandate inclusion of awarning concerning IV-push administration on Phenergan’s label wasanalogous to the regulatory balance struck by the DOT in formulating therestraint device regulation that was the subject of the Geier case.133 Bothregulations, Justice Alito wrote, were considered policy judgments.134 Thus,the majority should have found that the FDA regulations preempted Levine’sstate law claims.135
The dissent took issue with the majority’s analysis relating to the
preemptive effect of the preamble to the 2006 FDA regulations.136 The dissentpointed out that the Geier court had specifically rejected the majority’sassertion that the preamble deserved no merit because the FDA had notconducted appropriate notice and comment rulemaking.137 Further, the dissent
127. Id. 128. Id. 129. Id. at 1218 (Alito, J., dissenting). 130. Id. at 1220. 131. Seeid. (“A faithful application of the Court’s conflict preemption cases compels the
conclusion that the FDA’s 40-year-long effort to regulate the safety and efficacy of Phenerganpreempts respondent’s tort suit. Indeed, that result follows directly from our conclusion inGeier) (emphasis added); see alsoid. at 1222 (“In its attempt to evade Geier’s applicability tothis case, the Court commits both factual and legal errors.”).
132. Seeid. at 1222. 133. Seeid. at 1220-21. 134. Seeid. at 1218, 1221 (“Rather, the real issue is whether a state tort jury can
countermand the FDA’s considered judgment that Phenergan’s FDA-mandated warning labelrenders its intravenous (IV) use ‘safe’.”) (emphasis added); see alsoid. at 1222 (“First, as afactual matter, it is demonstrably untrue that the FDA failed to consider (and strike a ‘balance’between) the specific costs and benefits associated with IV push.”).
135. Seeid. at 1221-22. 136. Seeid. at 1228. 137. Id. at 1227.
found the majority’s distinction of Geier unpersuasive because the Departmentof Transportation’s regulation in that case bore the force of law while the 2006preamble did not.138 The dissent opined that such a distinction was irrelevant,as the FDA regulations themselves bore the force of law.139
The dissent concluded by professing the belief that juries were ill-equipped
to perform a cost-benefit analysis of the adequacy of prescription druglabels.140 Instead, that analysis should have been left to the expertise of theFDA.141
The Supreme Court’s holding that FDA drug labeling regulations do not
preempt state failure-to-warn lawsuits is incorrect in three important respects. First, the Wyeth majority erroneously relied on the presumption againstpreemption. Second, given the Court’s reasoning in Buckman Co. v. Plaintiff’sLegal Committee, the Wyeth majority should have found that FDA labelingrequirements preempted Levine’s state law action pursuant to the doctrine ofconflict preemption—lawsuits like Levine’s obstruct the purposes andobjectives of the FDA. Instead, the Court focused heavily on Congress’sdecision to omit an express preemption clause from the original Food, Drugand Cosmetic Act (FDCA) and subsequent amendments thereto, confusing thedistinction between express preemption and conflict preemption. Third, theCourt’s holding marks a significant departure from Geier v. American HondaMotor Co. As the dissent stated, the Court’s reasoning in Geier should havecompelled the Wyeth majority to honor the FDA’s preemption views.
A. The Presumption Against Preemption Should Not Have Applied inWyeth
The first flaw in the Wyeth decision is the Court’s misplaced reliance on the
presumption against federal preemption of state laws. The Supreme Court hasestablished that there is a general presumption against federal preemption ofstate laws when Congress legislates “in a field which the States havetraditionally occupied.”142 The states have regulated food and drugs since theUnited States’ inception.143 It is the federal government, however, and not the
138. Seeid. at 1228. 139. Id. 140. Seeid. at 1229. 141. Seeid. at 1229-30. 142. Medtronic v. Lohr, 518 U.S. 470, 485 (1996) (emphasis added) (“Because the States
are independent sovereigns in our federal system, we have long presumed that Congress doesnot cavalierly preempt state-law causes of action.”).
143. See Davis, supra note 13, at 1100 (“The states had regulated the safety of food and
states, that has historically been the primary regulator of food and drugs soldin interstate commerce.144
“Federal regulation of food and drugs occurred as early as the mid-
nineteenth century.”145 In 1848, Congress passed the Drug Importation Act,which required the U.S. Customs Service Inspection to stop entry ofadulterated drugs into the United States.146 In 1906, Congress enacted the PureFood and Drug Act.147 The Pure Food and Drug Act prohibited “interstatecommerce in misbranded and adulterated foods, drinks, and drugs.”148 Thestates did not resist Congress’s exertion of federal power in passing the PureFood and Drug Act, as one would expect if regulation of drugs sold ininterstate commerce were a field the states had traditionally occupied. Rather,the states implored the federal government to engage in such regulation out ofconcern that they [the states] would prove unable to do so sufficiently.149
The Supreme Court confirmed the federal government’s predominance in
regulating prescription drugs in interstate commerce with its ruling inMcDermott v. Wisconsin.150 In McDermott, the Court considered a Wisconsinstate law barring all labeling of food or drugs not permitted by Wisconsinlaw.151 Striking down the law, the Court held that it imposed too great aburden on interstate commerce and directly conflicted with the Pure Food andDrug Act of 1906.152
Phenergan’s manufacturer (Wyeth), like virtually all prescription drug
manufacturers, sells the drug in interstate commerce. Considering the federalgovernment’s primacy in regulating food and drugs in interstate commerce, theCourt in Wyeth should not have applied the presumption against preemptionto FDA prescription drug regulations. Had the presumption againstpreemption not applied in this case, it is likely the result would have mirroredthat reached by the Court in Buckman, where—operating under an analytical
drugs since the earliest days of the United States’ history.”).
144. Seeid. 145. Id. at 1099. 146. U.S. FOOD & DRUG ADMIN., Significant Dates in U.S. Food and Drug Law History,
http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm (last visitedon Nov. 8, 2009).
147. Id. 148. Id. 149. Davis, supra note 13, at 1100 (citing JAMES T. O’REILLY, FOOD AND DRUG
ADMINISTRATION §§ 3:1-:4 (2d ed. 2005)).
150. 228 U.S. 115 (1913). 151. See John Shaeffer, Prescription Drug Advertising—Should States Regulate What isFalse and Misleading?, 58 FOOD & DRUG L.J. 629, 634 (2003) (discussing McDermott v. Wisconsin).
framework presupposing no presumption against preemption—the Court foundthat the Medical Device Amendments to the FDCA preempted the plaintiffs’fraud claims under state law.153
B. An Obstruction of the FDA’s Purposes and Objectives: Why the CourtShould Have Found Conflict Preemption Based on Buckman
The second flaw in the Court’s decision is its failure to embrace Buckman
and find that conflict preemption doctrine preempted Levine’s state law claimsagainst Wyeth. It has long been the Supreme Court’s position that “conflictpreemption occurs when state law stands as an obstacle to the accomplishmentand execution of the full purpose and objectives of Congress in enacting afederal law.”154 Although there is no steadfast rule concerning when the Courtwill deem state law an impediment to Congress’s purposes and objectives inlegislating, the rationale underlying the 2000 Buckman decision should havepersuaded the Court in Wyeth to hold that state failure-to-warn actions impedeCongress’s purposes and objectives in granting the FDA authority topromulgate labeling standards for prescription drugs.
In a unanimous opinion, which included all six members of the Wyeth
majority, the Buckman Court held that the Medical Device Amendments(MDA) to the FDCA preempted a state law action against manufacturers oforthopedic screws which alleged that the manufacturers defrauded the FDA ingaining approval of the screws.155 Chief among the Buckman Court’s reasonsfor rendering the aforementioned determination was its belief that Congressenacted the MDA intending to free medical device manufacturers from statetort regimes.156 Allowing the state fraud claims to proceed would haveabrogated Congress’s purpose for enacting the MDA and created greaterburdens on medical device manufacturers than Congress foresaw, thuspreventing the FDA from executing its responsibility to police fraud.157Furthermore, the Court believed subjecting medical device manufacturers to
153. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). The extent of the
paradigm shift that occurs when the presumption against preemption is inapplicable is notentirely clear. It has been suggested by some, however, that–in the absence of the presumptionagainst preemption–the Court broadens its definition of what constitutes “conflict” under thedoctrine of conflict preemption. See Mary J. Davis, The New Presumption Against Preemption61 HASTINGS L.J. 1217, 1252 (2010).
154. Susan D. Hall, Preemption Analysis After Geier v. American Honda Motor Co., 90 KY.
L.J. 251, 252 (2002) (quoting Savage v. Jones, 225 U.S. 501 (1912) (holding that federal lawdid not preempt a state law requiring manufacturers of medicinal feed to disclose ingredients)).
155. Buckman, 531 U.S. at 343-44. The Wyeth majority includes Justices Stevens, Kennedy,
Souter, Ginsburg, Breyer, and Thomas. See Wyeth v. Levine, 129 S. Ct. 1187, 1190 (2009).
156. Buckman, 531 U.S. at 352. 157. Id. at 350.
state tort regimes would cause manufacturers to submit more information tothe FDA, which would slow the approval process and negatively affectcompetition in the medical device industry.158
The Court’s rationale in Buckman is directly applicable to Wyeth. As in
Buckman, there was evidence available to the Wyeth court indicating Congressdid not contemplate that drug makers would be liable under state tort law afterobtaining FDA approval of their labels.159 In fact, the majority itself cited onepiece of evidence supporting the conclusion that Congress desired to shielddrug manufacturers from state tort liability: the first version of the FDCAprovided a federal cause of action to persons injured by prescription drugs.160More persuasive is the extraordinary breadth of the FDA drug approvalprocess.161 Taking into account the FDA drug approval process’sextensiveness, one has difficulty concluding that Congress contemplated a rolefor the states in judging drug safety after FDA approval.
Moreover, the Court contended in Buckman that medical device
manufacturers would present the FDA with too much information if subjectedto liability under state tort law, an assertion equally valid in the case of drugmanufacturers. Like medical device manufacturers, drug manufacturersprobably divulge even minimally supported safety information to the FDAduring the approval process as a means of limiting future legal liability. Therefore, if concern over excessive information submission to the FDA wassufficient to find state law an impediment to federal objectives and purposesand trigger conflict preemption in Buckman, the same should have been truein Wyeth.
Rather than applying Buckman’s analysis, however, the Wyeth court
concentrated on the lack of an express preemption clause in the portion of theFDCA pertaining to drug regulation.162 Keying on the absence of an expresspreemption clause in the FDCA was erroneous given the Court’s priorstatements on the doctrine of conflict preemption, a point Justice Alitoarticulated in his dissent.163 By blurring the distinction between express andconflict preemption with unwarranted attention to the nonexistence of an
158. Id. at 351. 159. SeeWyeth, 129 S. Ct. at 1199-200 (citing H.R. 6110, 73d Cong., § 25 (1st Sess. 1933)). 160. Seeid. 161. See discussion supra Part II.A. 162. SeeWyeth, 129 S. Ct. at 1200 (“If Congress thought state-law suits posed an obstacle
to its objectives, it surely would have enacted an express pre-emption provision at some pointduring the FDCA’s 70-year history.”).
163. Seeid. at 1220 (Alito, J., dissenting) (“[T]he ordinary principles of conflict pre-emption
turn solely on whether a State has upset the regulatory balance struck by the federal agency.”(emphasis added)); see also Chicago & N. W. Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 317 (1981).
express preemption provision in the FDCA, the Wyeth court not onlyimproperly applied conflict preemption doctrine, but also essentially abrogatedconflict preemption doctrine altogether. Henceforth, the Court can applyconflict preemption only if Congress explicitly declares state law a barrier toaccomplishing its legislative objectives. Such a dismantling of conflictpreemption doctrine indicates that the Court reached the wrong result. C. Driving Away From Precedent: Geier v. American Honda Motor Co. Inc. Should Have Compelled Deference to the 2006 FDA Preamble
The final legal shortcoming of the Supreme Court’s analysis in Wyeth is that
the Court did not defer to the FDA’s view on the preemptive force of itsregulations, as reflected by the 2006 FDA preamble.164 Honoring the FDA’sviews concerning the preemptive effect of its regulations is something theCourt should have done in light of its decision in Geier v. American HondaMotor Co., Inc. In Geier, the Supreme Court declared that the Department ofTransportation’s (DOT) 1984 Federal Motor Vehicle Standard (FMVSS)preempted an injured motorist’s defective design action against an automobilemanufacturer under District of Columbia tort law.165 The Court’s rulingstemmed at least in part from its belief that the DOT’s interpretation regardingthe preemptive effect of the FVMSS was entitled to consideration given theextensive background of its investigation into the merits of automobile safetydevices and the complexity involved in the issue.166
In working with Wyeth Pharmaceuticals to formulate a warning label for
Phenergan, the FDA conducted an investigation as extensive—if not moreso—than the DOT investigation of automobile safety devices in Geier. JusticeAlito offered ample evidence supporting the aforementioned conclusion in hisdissenting opinion in Wyeth. Justice Alito noted that “Phenergan’s warninglabel has been subject to the FDA’s strict regulatory oversight since the1950's” and that the FDA paid particular attention to the safety andeffectiveness of IV-push administration as it related to Phenergan’s warninglabel.167 The FDA, moreover, convened meetings with Wyeth specificallydevoted to discussing Phenergan’s warning label and commissioned an
164. In its 2006 preamble, the FDA stated that the FDCA “establishes both a ‘floor’ and a
‘ceiling’ . . . FDA approval of labeling . . . preempts conflicting or contrary State law.” Wyeth,129 S. Ct. at 1200 (majority opinion).
165. Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000). See discussion supra Part II.C.1.
for an in-depth explanation of the 1984 Department of Transportation Motor Vehicle SafetyStandard.
166. SeeGeier, 529 U.S. at 883. 167. Wyeth, 129 S. Ct. at 1222 (Alito, J., dissenting). For explanation of the IV-push
method, seesupra Part III.A.
advisory committee to study the inherent risks of Phenergan when injected viathe IV-push method of intravenous drug administration.168 Based on thestudy’s findings and other research, the FDA instructed Wyeth to place awarning regarding IV-push on Phenergan’s label.169 The FDA did not,however, prohibit the IV-push method for administering Phenergan.170
Additionally, the complexity of prescription drug labeling is analogous to
that of automobile safety devices. Both issues require specialized knowledgeand expertise that Congress, state legislatures, the public, and juries areunlikely to possess. The DOT and FDA occupy a unique position from whichto render considered judgments in the areas of automobile safety devices andprescription drug labeling, respectively.
The processes by which the DOT established regulations for automobile
safety devices and the FDA decided the permissibility of IV-pushadministration of Phenergan are virtually indistinguishable. Thus, the Wyethmajority’s refusal to give the FDA’s statement that its guidelines preemptedstate law—as expressed in the 2006 FDA preamble—the same force it gavethe DOT’s preemption views in Geier was improper. V. The Implications of Wyeth v. Levine for Oklahoma
The Supreme Court’s decision in Wyeth v. Levine presents two major
implications for Oklahoma. First, Wyeth will lead to an increase inprescription drug prices. Oklahoma’s senior citizen population, in comparisonto the national average, is proportionately larger than most other states, andmany of those seniors are either uninsured or ineligible for governmentprograms that subsidize prescription drug purchases.171 Therefore, anyincrease in the cost of prescription drugs will affect Oklahoma more than moststates. Second, the Supreme Court’s ruling in Wyeth will prove greatlybeneficial to Oklahoma tort practitioners by making it easier to litigatesuccessfully against pharmaceutical companies. A. Wyeth v. Levine Will Increase Prescription Drug Prices1. Litigation Hinders Pharmaceutical Development
Litigation encumbers pharmaceutical development, which, in turn, causes
an asymmetry between supply and demand—triggering a rise in the cost ofprescription drugs. Litigation hinders pharmaceutical development in two
168. Wyeth, 129 S. Ct. at 1222. 169. Id. at 1225. 170. Seeid. (“While Phenergan’s label very clearly authorized the use of IV push . . . .”). 171. Seeinfra Part V.A.4.
primary ways. First, litigation forces pharmaceutical companies to expendcapital they would otherwise devote to research and development on legalservices.172 The drug industry spends sizable sums hiring in-house and outsidecounsel to offer legal advice and defend lawsuits initiated by consumers.173Further, drug companies must carry liability insurance policies or,alternatively, self-insure if they deem premiums charged by insurers to beexcessive.174 Secondly, litigation discourages pharmaceutical developmentbecause of its inherent unpredictability.175 Like all businesses, drug companiesmust balance risk and reward in determining whether to bring their product tomarket, and product liability entails present and future risks that, whilevirtually impossible to quantify, could lead to the company’s financial ruin.176
2. A Comparison of the U.S. and Canadian Liability Systems Shows ThatLitigation Results in Higher Prescription Drug Prices
Comparing the U.S. and Canadian liability systems illustrates that litigation
directly correlates with higher prescription drug costs. Though the U.S. andCanada each model their liability system on English common law, therespective systems have important differences.177 Most importantly, the U.Shas adopted strict products liability while Canada relies solely on a negligencestandard.178 Other distinctions include the advent of market share liability inthe U.S., limited rights of appeal for Canadian litigants compared to their U.S. counterparts, and fewer punitive damages awards in Canada than in the U.S.179
A 1992 study by the U.S. General Accounting Office (GAO) discovered
large price differences for the same drugs sold in both the U.S. and Canada.180A sample of 121 commonly prescribed drugs sold in both the U.S. and Canada
172. See Louis Lasagna, The Chilling Effect of Product Liability on New Drug Development,
in THE LIABILITY MAZE: THE IMPACT OF LIABILITY LAW ON SAFETY AND INNOVATION, 334,335-36 (Peter W. Hubert & Robert E. Litan eds., 1991).
173. Id. 174. Id. at 337. 175. Id. 176. Id. 177. Richard L. Manning, Products Liability and Prescription Drug Prices in Canada andthe United States, 40 J.L. & ECON. 203, 206 (1997) (discussing how the United States liabilitysystem has drifted considerably from the common law heritage it shares with the Canadiansystem).
178. Id. at 206-07. 179. Id. at 207-08. Market share liability is a theory of damages whereby each defendant
manufacturer of a drug pays a percentage of the plaintiff’s damages equal to their share of themarket, if the court cannot determine which manufacturer is responsible for making the drugcausing the injury.
found that the median price was about forty-three percent higher in the U.S. than in Canada.181 Criticism of the GAO study was widespread, as someexperts believed the study’s methodology was biased in favor of finding higherprices in the U.S.182 But a study by Professor Richard L. Manning of BrighamYoung University in the Journal of Law and Economics confirms the GAOstudy’s conclusion that prescription drug prices are lower in Canada, andproves that the disparity results from the differing liability systems.183
Professor Manning’s study calculated drug prices based on four variables:
manufacturing and marketing costs, the regulatory environment in which thecompany sells its products, the liability environment which prevails in themarket, and the structure of the market for each product.184 Manningincorporated the effects of the liability environment prevailing in the marketby measuring four risks: litigation history, vaccine liability cost, controlledsubstances designation, and risk assessment surveys of health professionals.185The results indicated that, when accounting for the effects of all four variables,the price differential between Canada and the United States amounted to “amean difference of 69.7 percent and a median difference of 43.6 percent.”186Removing the liability cost variable, however, resulted in a reduction of themean price differential to 35.5 percent and a reduction of the mediandifference to 32.6 percent.187 Manning’s study found that the proportion ofcases won by plaintiffs had a particularly substantial effect on pricedifference,188 which is notable given that Wyeth will enhance plaintiffs’chances of prevailing over drug companies in products liability cases bypreventing drug companies from proffering preemption defenses based onFDA labeling requirements. 3. The Story of Bendectin: A Practical Example
Bendectin, a drug prescribed to alleviate nausea and vomiting
accompanying pregnancy,189 is a practical example of litigation’s effect oninnovation, drug prices, and—ultimately—availability of the drug itself. Firstintroduced to the U.S. market in 1956, Bendectin achieved great success; bythe time its manufacturer withdrew Bendectin from the market, it was sold in
181. Id. 182. Id. 183. Seeid. 184. Id. at 209. 185. Id. at 217-22. 186. Id. at 206. 187. Id. 188. Id. at 223. 189. Lasagna, supra note 172, at 337.
twenty-two countries and used by around twenty-five percent of pregnantwomen in America.190 Epidemiological research into Bendectin’s effect onbirth defects produced mixed results.191 The FDA also investigated Bendectin,determining that “this drug has been the most carefully studied of all drugswhich could be used to treat the nausea and vomiting of pregnancy. There isno evidence that any other drug is safer in treating [this condition].”192 Yetmany suits came to trial, and although Merrell (Bendectin’s manufacturer) wonthe great majority of them, the company pulled Bendectin from the marketciting unsustainable legal costs.193 Consequently, pregnant women lost the onlyprescription drug then available for treating nausea and vomiting.194
4. Overdose: How an Increase in Prescription Drug Costs is EspeciallyProblematic for Oklahoma
Due to Oklahoma’s population demographics and other economic factors,
the prescription drug cost increases Wyeth v. Levine portends will proveexceedingly harmful to the state. Senior citizens, who invariably utilizeprescription drugs more than adults and children, make up a significant portionof Oklahoma’s population.195 According to the AARP, thirteen percent ofOklahoma’s population is age sixty-five or older.196 This figure placesOklahoma ahead of thirty states in terms of percentage of the population oversixty-five years old.197 Eighteen percent of Oklahoma’s population is betweenthe ages of fifty and sixty-four.198
Oklahoma also has a high number of individuals lacking health insurance
coverage, especially among the elderly.199 In 2007, 94,551 Oklahomansbetween the ages of fifty and sixty-four were uninsured.200 Moreover, thirtypercent of Oklahoma’s seniors in 2007 were not eligible for the Medicare PartD Low Income Subsidy—meaning they had to pay the full cost of their
190. Id. at 338. 191. Id. at 339. 192. Id. at 340. 193. Id. 194. Id. 195. See AARP, WHY HEALTH CARE REFORM IN OKLAHOMA 1 (2009), available at http://
196. Id. 197. U.S. CENSUS BUREAU, RANKING OF STATES BY PROJECTED PERCENT OF POPULATION
AGE 65 AND OVER: 2000, 2010, 2030 (2004), http://www.census.gov/population/www/projections/projectionsagesex.html.
198. AARP, supra note 195, at 1. 199. Seeid. 200. Id.
prescription medications for at least part of the year.201 By comparison,twenty-three percent of Florida’s seniors, nineteen percent of Arizona’sseniors, and twenty-seven of Utah’s seniors were ineligible for the MedicarePart D Low Income Subsidy in 2007.202
In sum, Oklahoma’s demographic realities mean an increase in prescription
drug costs generated by Wyeth will disproportionately affect the state. Due togreater incidences of illness and disease, senior citizens’ consumption ofprescription drugs far exceeds prescription drug consumption among otherpopulation groups.203 Not only does Oklahoma’s senior citizen populationsurpass that of most states, but also the number of seniors in Oklahoma whoare ineligible for prescription drug subsidies under Medicare is greater than intraditional retirement destinations such as Florida and Arizona.204 Therefore,the Wyeth case should be of particular concern to Oklahomans alreadystruggling to pay for prescription drugs.
B. Wyeth v. Levine Will Benefit Oklahoma Tort PractitionersWyeth v. Levine will affect Oklahoma in a second, noteworthy way: by
enabling plaintiffs to sue drug manufacturers post-FDA approval, Wyeth willencourage the proliferation of failure-to-warn claims, which will in turnencourage the proliferation of Oklahoma tort practitioners’ business.
Prior to the Supreme Court’s decision in Wyeth, injured consumers could
not bring actions against pharmaceutical companies in Oklahoma forinadequate warnings on FDA-approved drugs; an Oklahoma federal court hadheld that FDA labeling requirements preempted failure-to-warn claims broughtpursuant to Oklahoma state law.205 With the Supreme Court’s ruling in Wyethv. Levine, however, Oklahoma plaintiffs are now much more likely to achieve
201. JACK HOADLEY ET AL., THE KAISER FAMILY FOUND., THE MEDICARE PART D
COVERAGE GAP: COSTS AND CONSEQUENCES IN 2007 6 (2008), available at http://www. kff.org/medicare/upload/7811.pdf. That amounts to about 66,550 people who had to pay 100%percent of their prescription drug costs. THE KAISER FAMILY FOUND., STATE HEALTH FACTS(2007), http://www.statehealthfacts.kff.org/comparetable.jsp?ind=3.
202. HOADLEY ET AL., supra note 201, at 6. 203. A study by the Centers for Disease Control and Prevention found that eighty-seven
percent of Americans over the age of sixty-five surveyed from 2001-2004 reported usingprescription drugs in the past month. Only sixty-six percent of 45-65 year-olds and thirty-eightpercent of 18-44 year-olds said they had used prescription drugs in the past month. CTRS. FORDISEASE CONTROL & PREVENTION, PRESCRIPTION DRUG USE IN THE PAST MONTH BY AGE, SEX,RACE AND HISPANIC ORIGIN: UNITED STATES, 1988-1994 AND 2001-2004 1 (2008), availableat http://www.cdc.gov/nchs/data/hus/hus08.pdf#098.
204. See HOADLEY ET AL., supra note 201, at 6. 205. See Dobbs v. Wyeth Pharm., 530 F. Supp. 2d 1275 (W.D. Okla. 2008). Seesupra Part
II.D. for a detailed summary of the case’s holding.
positive outcomes in suits against drug companies because drug companieswill be hard-pressed to argue that federal law preempts state failure-to-warnclaims.206
Scholars and attorneys agree that the increased likelihood of success by
plaintiffs whose claims FDA regulations would have previously preempted hasshifted incentives in favor of trial lawyers. “Some trial lawyers who have beenhesitant to bring claims against pharmaceutical companies are now going tobe more willing to do so,” Benjamin C. Zipursky, professor of law at FordhamLaw School in New York City and visiting professor at Harvard Law School,states.207 Referring to Wyeth, corporate defense attorney John Beisner echoedthe sentiments of Professor Zipursky, saying, “We’re going to see a substantialuptick in the number of cases filed.”208
Indeed, the weeks immediately following the Supreme Court’s Wyeth
decision saw judges in state and federal courts around the country permitupwards of 250 previously stayed lawsuits to move forward.209 Moreover,recent data suggests that jurors are becoming more sympathetic to plaintiffs inproduct liability cases.210 Last year, the five most lucrative product liabilityverdicts rose fifty-two percent, with Pfizer—perhaps the best-knownpharmaceutical company in America—losing verdicts of $78 million and $34million.211 “It’s a reflection of the fact that Main Street is hurting,” said TobiasMillrood, attorney for the plaintiffs in the $34 million case against Pfizer.212“In this climate [alluding to the recent financial collapse and economicdownturn], there’s a strong identification with the little man,” said Millrood.213
All told, Wyeth v. Levine is a positive development for Oklahoma’s tort bar.
Bound by Wyeth, Oklahoma courts must now reject preemption defenses theypreviously allowed to block state failure-to-warn claims againstpharmaceutical companies. Accordingly, Oklahoma tort practitioners canhenceforth successfully try cases they would not have even taken before
206. Seesupra Part III.B for a thorough discussion of the Supreme Court’s holding in Wyeth
207. Amanda Gardner, Supreme Court Rejects Limits on Drug-Injury Lawsuits, U.S. NEWS
& WORLD REPORT, Mar. 4, 2009, http://www.usnews.com/health-news/managing-your-healthcare/policy/articles/2009/03/04/supreme-court-rejects-limits-on-drug-injury.html.
208. Margaret Cronin Fisk, Jurors Turned Against Companies in 2009 Product-DefectCases, BLOOMBERG, Jan. 7, 2010, http://www.bloomberg.com/apps/news?pid=newsarchive&sid=awwb48rn7sQQ.
209. Id. 210. Seeid. (stating five of the fifty largest verdicts were claims involving defective
211. Id. 212. Id. 213. Id.Wyeth. Combined with a growing sensibility favoring product liabilityplaintiffs in the wake of the worst recession since the Great Depression, theability to sue drug companies for failure to warn despite compliance with FDAregulations means Wyeth v. Levine will serve as a boon to Oklahoma’s tortpractitioners. Nonetheless, a victory for the tort bar is not a victory for theaverage Oklahoma citizen. That Wyeth will enable tort lawyers to grow theirpractices excuses neither the Supreme Court’s flawed legal reasoning nor thegrowth in prescription drug prices the decision will doubtless produce. Wyeth v. Levine is among the most consequential preemption cases of our
time, which makes the Supreme Court’s failure to reach the proper result verytroubling. The Court misconstrued preemption doctrine, deviating from well-established principles and avoiding the direct applicability of recent case law. Perhaps more worrisome was the Court’s inability to grasp the economicimplications of its decision. Without the shield of FDA approval, drugmanufacturers will face a barrage of state tort lawsuits—and the result will beclimbing prices for prescription medications. While the rise in litigation iswelcome news for Oklahoma trial lawyers, it has the potential to becatastrophic for the state’s many seniors—who already struggle to afford themedicines vital to their health. The Supreme Court should revisit Wyeth v. Levine and overturn its wrongheaded decision at the firstopportunity—restoring the FDA to its position as the rightful arbiter of drugsafety by ruling that FDA regulations preempt contrary state lawsuits. Because the fact is, Wyeth v. Levine is a dose of bad medicine Oklahomacannot afford.
INTERNATIONAL JOURNAL OF PSYCHOTHERAPHY, VOL. 5, NO. 2, 2000 An inspired resurrection of Freudian drive theory: but does Nick Totton’s Reichian `bodymind’ concept supersede Cartesian dualism? Review article on Nick Totton’s The Water in the Glass: body and mind in psychoanalysis , London: Rebus Press, 1998, 266 pp., ISBN: L 900877 L2 0 Minster Centre/Scarborough Psychotherapy Training
infection control and hospital epidemiology Use of Gaseous Ozone for Eradication mg/L), and linezolid (MIC, 0.75 mg/L), and was susceptibleto mupirocin by disk diffusion; the strain was resistant to of Methicillin-Resistant Staphylococcus oxacillin (MIC, 24 mg/L) and erythromycin (MIC, 16 mg/L) aureus From the Home Environment by E-test, and to clindamycin by disk diffusion test (di