IN THE SUPREME COURT OF THE STATE OF FLORIDA CASE NO.: SC07-1334 Court of Appeal s Case No.: 3D06-2733 YOLANDA PROHIAS, et al., Petitioner, vs. ASTRAZENECA PHARMACEUTICALS, et al., Respondents. ON PETITION FOR DISCRETIONARY REVIEW FROM THE FLORIDA THIRD DISTRICT COURT OF APPEAL PETITIONER S BRIEF ON JURISDICTION Steve W. Berman, Esq. Craig R. Spiegel, Esq. HAGENS BERMAN SOBOL SHAPIRO LLP 1301 Fifth Avenue, Suite 2900 Seattle, WA 98101 Telephone: (206) 623-7292 Facsimile: (206) 623-0594 Lance Harke, Esq. Florida Bar No. 863599. David J. Maher, Esq. Florida Bar No. 0993484 HARKE & CLASBY LLP 155 South Miami Avenue, Suite 600 Miami, Florida 33130 Telephone: (305) 536-8222 Facsimile: (305) 536-8229 Counsel for Petitioner Yolanda Prohias
TABLE OF CONTENTS PAGE I. STATEMENT OF THE CASE AND FACTS...1 A. Plaintiff s Allegations...1 B. The Lower Court Rulings...4 II. SUMMARY OF ARGUMENT...4 III. ARGUMENT...5 A. This Court Should Review the Preemption Decision...5 1. The decision of the Court of Appeal expressly construes a provision of the federal constitution...5 2. The Decision of the Court of Appeal Conflicts With Boca Burger, Inc. v. Forum, 912 So. 2d 561 (Fla. 2005)...7 B. This Court Should Review the Court of Appeal s Ruling that the Safe Harbor Provision of FDUTPA Bars Plaintiff s Claims...8 IV. CONCLUSION...10 -i-
TABLE OF AUTHORITIES CASES PAGE Boca Burger, Inc. v. Forum, 912 So. 2d 561 (Fla. 2005)... 5, 7 Ford Motor Co. v. Kikis, 401 So. 2d 1341 (Fla. 1981)...8 Geier v. American Honda Motor Co., 529 U.S. 861 (2000)...6 Ivey v. Allstate Ins. Co., 774 So. 2d 679 (Fla. 2000)...8 Jacobson v. State, 476 So. 2d 1282 (Fla. 1985)...5 Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001)...6 Metropolitan Dade County v. Miami, 396 So. 2d 144 (Fla. 1980)... 10 Office of the AG, Dep t of Legal Affairs v. Commerce Comm. Leasing, LLC, 946 So. 2d 1253 (Fla. 1st DCA 2007)...9 Sloan v. Hutchinson, 120 Fla. 747 (1935)... 10 State v. Hearns, So. 2d, 2007 Fla. Lexis 718 (Fla. Apr. 26, 2007)... 10 -ii-
STATUTES/RULES Florida Deceptive and Unfair Trade Practices Act, Fla. Stat. 501.201 et seq...1 Fla. R. App. P. 9.030(a)(2)A(ii)...5 -iii-
I. STATEMENT OF THE CASE AND FACTS A. Plaintiff s Allegations Plaintiff alleges that defendants AstraZeneca Pharmaceuticals L.P. and Zeneca, Inc. (collectively, AstraZeneca ) engaged in a multi-faceted campaign to unfairly and deceptively promote the prescription drug Nexium as superior to the prescription drug Prilosec, also known as omeprazole. Plaintiff would not have bought Nexium at all or would have paid a significantly lower price if not for that wrongful conduct, because Nexium is not superior to Prilosec. Plaintiff alleges that AstraZeneca violated the Florida Deceptive and Unfair Trade Practices Act ( FDUTPA ), Fla. Stat. 501.201 et seq. and the law of unjust enrichment. Prilosec is a proton-pump-inhibitor used in the treatment of heartburn. By 2000, sales of Prilosec had reached $6 billion, making it the top selling drug in the world. 2. 1 Prilosec s patent protection was set to expire, which would result in generic competition and a loss of billions of dollars for AstraZeneca. AstraZeneca chose Nexium to replace Prilosec, but in order to convince doctors and consumers to use Nexium, AstraZeneca had to convince them that Nexium was superior. 7. AstraZeneca conducted trials comparing Nexium to a placebo, all that is required to obtain FDA approval. 9. But it also conducted trials that compared Nexium to 1 All paragraph references are to the second amended complaint. -1-
Prilosec, which it submitted to the FDA, hoping to have a basis for claiming that Nexium was superior to Prilosec. 41-60. Based on these clinical trials, the FDA approved Nexium for the healing of erosive esophagitis, maintenance of healing of erosive esophagitis and treating gastroesophageal reflux disease ( GERD ). The FDA did not, however, approve Nexium as a superior product to Prilosec. To the contrary, the FDA reviewers found that for the healing of erosive esophagitis, a superiority claim of Nexium over omeprazole [i.e., Prilosec] is not supported. 56. For the maintenance of healing of erosive esophagitis, AstraZeneca s studied compared various doses of Nexium to placebo only, not Prilosec, so the FDA did not find that Nexium is superior to Prilosec. Nor was there support for a superiority claim for treating symptomatic GERD. 58 ( claims of superiority [of Nexium] to omeprazole are once again not supported ). Thus, in giving AstraZeneca approval to market Nexium, the FDA explained that Nexium is not better than Prilosec. 53. Over a period of several months, AstraZeneca and the FDA negotiated the contents of the label for Nexium in light of the results of the clinical trials. 61. During the course of those negotiations, the FDA made clear that it would not approve any statement by AstraZeneca that Nexium is superior to Prilosec. 62. Late in the negotiations, twelve AstraZeneca representatives met with eight FDA -2-
representatives on February 6, 2001. Id. AstraZeneca s minutes of that meeting stated that one of its attendees was Mark Mallon, MBA, Vice President, GI. Id. The minutes also state: Mr. Mallon clarified that 40 mg of Nexium gives higher healing rates than omeprazole 20 mg, and that AstraZeneca is not stating that Nexium is better than omeprazole. Id. (emphasis added). The minutes also list one of the FDA attendees as Florence Houn, M.D., Director. Id. The minutes then state: Dr. Houn stated that 40 mg is very good and 20 mg also works. She stated that they do want to show this data. The concern they had was to make physicians understand that Nexium is not superior to omeprazole. Id. (emphasis added). Consistent with the statements by Mr. Mallon and Dr. Houn, the Nexium label approved by the FDA does not permit or support AstraZeneca s assertion that Nexium is better than or superior to Prilosec (omeprazole). 63. After the FDA approved Nexium, AstraZeneca began promoting Nexium in a massive campaign aimed at doctors, managed care companies, and consumers. 79. The goal and effect of the campaign was to convince consumers to ask their doctors to prescribe Nexium rather than Prilosec, to convince doctors that Nexium is superior to Prilosec, and to convince managed care companies to add Nexium to their formularies because Nexium allegedly was clinically superior to Prilosec, even though Nexium in fact is not clinically superior to Prilosec and even though -3-
the FDA-approved label for Nexium does not allow AstraZeneca to claim that Nexium is superior to Prilosec. Sales of Prilosec plummeted in response to generic competition, as AstraZeneca expected. 106. Conversely, sales of Nexium skyrocketed. Id. After establishing Nexium s position, AstraZeneca raised the price of Nexium while the price of Prilosec dropped. 107. Nexium now generally sells for more than $5.00 per pill versus $0.67 per pill or less for Prilosec. Id. B. The Lower Court Rulings The trial court dismissed Plaintiff s claims on three grounds: (1) federal preemption; (2) the safe harbor provision of FDUTPA; and (3) failure to state a claim for relief. See Appendix hereto (decision of Court of Appeal) at 2 (hereafter, the Opinion ). After quoting the entire trial court order, the Court of Appeal adopted the trial court s reasoning as its own, stating: We entirely agree with this ruling. Id. at 3. The Court of Appeal then listed four cases without discussion. II. SUMMARY OF ARGUMENT This Court should review the Court of Appeal s preemption decision, which rests on the Supremacy Clause of the federal constitution and is contrary to the well-established law of preemption. The rulings below allow a drug manufacturer to falsely hype a drug to thousand of Floridians in direct contradiction to the -4-
FDA s approval. This Court should review the preemption decision for the additional reason that it conflicts with Boca Burger, Inc. v. Forum, 912 So. 2d 561 (Fla. 2005), in which this Court required courts to accept all well-pleaded allegations in ruling on a preemption defense at the pleading stage, because the courts below did not accept Plaintiff s allegation that the FDA explicitly told AstraZeneca that physicians should be informed that Nexium is not superior to Prilosec. This Court should also review the Court of Appeal s ruling regarding the safe harbor provision of FDUTPA, because that ruling conflicts with numerous rulings by this Court and another district court of appeal regarding the meaning of the phrase specifically permitted in that provision. 2 III. ARGUMENT A. This Court Should Review the Preemption Decision 1. The decision of the Court of Appeal expressly construes a provision of the federal constitution Pursuant to Fla. R. App. P. 9.030(a)(2)A(ii), this Court should review the Court of Appeal s ruling that the federal law of preemption bars Plaintiff s claims. The trial court held that, as a matter of law, Plaintiff s state law claims would 2 Once the Court accepts review in a case, it may review all issues. See Jacobson v. State, 476 So. 2d 1282, 1285 (Fla. 1985) ( Having jurisdiction, we have jurisdiction over all issues, Savoie v. State, 422 So. 2d 308 (Fla. 1982), and dispose of the case on a ground other than the conflict ground. ). -5-
conflict with federal law and the FDA-approved Nexium labeling and therefore are preempted. Opinion at 2 (quoting trial court). The Court of Appeal adopted the trial court s reasoning as its own after quoting the entire trial court decisions. Id. at 3. That ruling necessarily construes the Supremacy Clause of the United States Constitution, which provides the basis for the law of preemption. That ruling also conflicts with well-established preemption law. In Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 541-42 (2001), the Court stated: Because federal law is said to bar state action in [a] field of traditional state regulation, namely, advertising, see Packer Corp. v. Utah, 285 U.S. 105, 108 (1932), we work on the assumption that the historic police powers of the States are not to be superseded by the Federal Act unless that [is] the clear and manifest purpose of Congress. Moreover, too easily implying pre-emption would be inconsistent with the federal-state balance embodied in our Supremacy Clause jurisprudence. Geier v. American Honda Motor Co., 529 U.S. 861, 909 (2000) (citation omitted). This Court should review the Court of Appeal s conclusion that Plaintiff s claims are barred by the doctrine of conflict preemption. The trial court only stated that the claims would conflict with federal law and the FDA-approved Nexium labeling and therefore are preempted. Opinion at 2. The Court of Appeal adopted that conclusion as its own. Id. at 3. Neither court, however, identified any portion -6-
of the Nexium label that conflicts with Plaintiff s allegations that AstraZeneca deceptively marketed Nexium as superior to Prilosec. Moreover, neither court acknowledged Plaintiff s allegations that: (1) the FDA found that the clinical studies submitted by AstraZeneca do not support a claim that Nexium is superior to Prilosec; (2) AstraZeneca s representative admitted in the labeling negotiations for Nexium that AstraZeneca is not stating that Nexium is better than omeprazole [i.e., Prilosec] ; and (3) the FDA s Dr. Houn stated during those negotiations that the FDA wanted to make physicians understand that Nexium is not superior to omeprazole. As a result, this Court should review the preemption decision by the Court of Appeal, which misapplies well-established preemption law. 2. The Decision of the Court of Appeal Conflicts With Boca Burger, Inc. v. Forum, 912 So. 2d 561 (Fla. 2005) Within the four corners of its opinion, the Court of Appeal s preemption ruling also conflicts with Boca Burger, Inc. v. Forum, 912 So. 2d 561, 568-69 (Fla. 2005), in which this Court stated: A defendant may, at its option, raise any affirmative defense, including the defense of federal preemption, in a motion to dismiss. Of course, when a defendant asserts such a defense in a motion to dismiss, a trial court must determine the issue as a matter of law based only on the well-pleaded allegations in the complaint, assuming the truth of the facts asserted. -7-
Contrary to that directive, the Court of Appeal in this action did not acknowledge well-pleaded allegations in the complaint. The Court did not discuss Plaintiff s allegations that the FDA explicitly found that Nexium is not superior to Prilosec, that AstraZeneca s representative admitted during the labeling negotiations that AstraZeneca is not stating that Nexium is better than omeprazole, and that the FDA s Dr. Houn stated during the negotiations that the FDA wanted to make physicians understand that Nexium is not superior to omeprazole. Nonetheless, the Court of Appeal ruled as a matter of law that the Nexium label preempts a claim that AstraZeneca misrepresented to consumers, physicians and others that Nexium is superior to Prilosec. This Court should review that ruling. 3 B. This Court Should Review the Court of Appeal s Ruling that the Safe Harbor Provision of FDUTPA Bars Plaintiff s Claims The Court of Appeal s interpretation of the safe harbor provision in FDUTPA also directly conflicts with numerous decisions by this Court and other district courts of appeal on the same question of law. The trial court held that, as a 3 The Court of Appeal s opinion need not cite Boca Burger in order for this Court to accept discretionary review. See Ford Motor Co. v. Kikis, 401 So. 2d 1341, 1342 (Fla. 1981) ( It is not necessary that a district court explicitly identify conflicting district court or supreme court decisions in its opinion in order to create an express conflict under section 3(b)(3). ). See also Ivey v. Allstate Ins. Co., 774 So. 2d 679, 681 (Fla. 2000) (accepting review because the Court of Appeal s decision conflicted with three other decisions, even though the Court of Appeal did not cite any of those three cases). -8-
matter of law, the promotional and advertising activity attacked in the Complaint is supported by the FDA-approved labeling for Nexium and thus is specifically permitted by federal law. Opinion at 2 (quoting trial court). The Court of Appeal likewise expressly adopted that reasoning. Id. at 3. This ruling is in direct conflict with Office of the AG, Dep t of Legal Affairs v. Commerce Commercial Leasing, LLC, 946 So. 2d 1253, 1259 (Fla. 1st DCA 2007), in which the court explained that the purpose of the [safe harbor] is obvious: it would be unacceptably inconsistent for one statute to penalize conduct mandated elsewhere. (Emphasis added.) The Court of Appeal in this case held that it was sufficient if the advertising is supported by the label, rather than if it is mandated by the label. This Court should resolve the conflict between those two rulings. The Court of Appeal s application of the supported by standard caused it to dismiss Plaintiff s claims, even though the Nexium label plainly does not specifically permit any claim that Nexium is superior to Prilosec and even thought the FDA expressly told AstraZeneca during labeling negotiations that it wanted physicians to know that Nexium is not superior to Prilosec. -9-
The Court of Appeal s ruling also conflicts with the interpretation by this Court that the phrase specifically permitted means expressly permitted. 4 See Metropolitan Dade County v. Miami, 396 So. 2d 144, 148 (Fla. 1980) ( Although the Dade County Home Rule Amendment allows that county to enact ordinances which conflict with state law, it can do so only when such conflict is in areas specifically authorized in the home rule amendment. We can find no provision in section 11 that expressly authorizes Dade County to contravene the method of transferring power set out in section 323.052(3). (emphasis added)); Sloan v. Hutchinson, 120 Fla. 747, 751 (1935) (interpreting phrase specifically permitted in ordinance to mean except as otherwise expressly permitted by general state law ). The Court of Appeal s decision in this case conflicts with those holdings, because the Nexium label plainly does not expressly permit AstraZeneca to claim that Nexium is superior to Prilosec. IV. CONCLUSION Plaintiff respectfully request that the Court review the decision of the Court of Appeal in this action. 4 This Court has explained that where the Legislature uses the exact same words or phrases in two different statutes, we may assume it intended the same meaning to apply. State v. Hearns, So. 2d,, 2007 Fla. Lexis 718, at *16 (Fla. Apr. 26, 2007). -10-
DATED: July, 2007 Respectfully submitted, By Lance Harke, Esq. Florida Bar No. 863599 David J. Maher, Esq. Florida Bar No. 0993484 Counsel for Petitioner HARKE & CLASBY LLP 155 S. Miami Ave., Suite 600 Miami, FL 33130 Telephone: (305) 536-8220 Facsimile: (305) 536-8229 Of Counsel: Steve W. Berman Craig R. Spiegel HAGENS BERMAN SOBOL SHAPIRO LLP 1301 Fifth Avenue, Suite 2900 Seattle, WA 98101 Telephone: (206) 623-7292 Facsimile: (206) 623-0594 Ben Barnow Sharon Harris BARNOW AND ASSOCIATES, P.C. One North LaSalle Street, Suite 4600 Chicago, IL 60602 Telephone: (312) 621-2000 Facsimile: (312) 641-5504 -11-
CERTIFICATE OF SERVICE Robert L. Ciotti, Esq. Carlton Fields, P.A. Corporate Center Three at International Plaza 4221 W. Boy Scout Boulevard Tampa, Florida 33607 Peter I. Ostroff, Esq. Mark E. Haddad, Esq. Sidley Austin Brown & Wood LLP 555 West Fifth Street, 40 th Floor Los Angeles, CA 90013 CERTIFICATION OF COMPLIANCE WITH FLA. R. APP. P. 9.210 Pursuant to Fla. R. App. P. 9.210(2), the undersigned hereby certifies that the foregoing Petition is submitted in Times New Roman 14-point font. By: David J. Maher, Esq. Florida Bar No. 0993484-12-