AstraZeneca LP v. TAP Pharmaceutical Products, Inc.

444 F. Supp. 2d 278, 2006 U.S. Dist. LEXIS 57410, 2006 WL 2338144
CourtDistrict Court, D. Delaware
DecidedJune 23, 2006
DocketCIV.A.04-1332 IW
StatusPublished
Cited by17 cases

This text of 444 F. Supp. 2d 278 (AstraZeneca LP v. TAP Pharmaceutical Products, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
AstraZeneca LP v. TAP Pharmaceutical Products, Inc., 444 F. Supp. 2d 278, 2006 U.S. Dist. LEXIS 57410, 2006 WL 2338144 (D. Del. 2006).

Opinion

MEMORANDUM OPINION

JORDAN, District Judge.

I. INTRODUCTION

In this false advertising case, AstraZ-eneca LP (“AstraZeneca”) filed a complaint requesting a declaratory judgment that its “Better is Better” advertising campaign was not false or misleading under § 43(a) of the Lanham Act, 15 U.S.C. § 1125(a)(1)(B). (Docket Item [“D.I.”] 1 at ¶ 15.) TAP Pharmaceutical Products, Inc. (“TAP”) counterclaimed for a judgment that AstraZeneca’s campaign was false, and likely to deceive consumers. (D.I. 7 at ¶¶ 34-35.) TAP demanded a jury trial for all issues so triable, and injunctive relief and damages. {Id. at 13-14.)

Presently before me are five motions filed by AstraZeneca and TAP. TAP has filed a Motion to Exclude Certain Testimony by Michael Rappeport, one of AstraZ-eneca’s expert witnesses. (D.I.87.) As-traZeneca has filed four motions, including a Motion for Summary Judgment (D.I.88), a Motion to Exclude Expert Testimony of Thomas Dupont and Susan S. McDonald (D.I.91), a Motion to Exclude Expert Testimony of Bert Spilker (D.I.94), and a Motion to Strike TAP’s jury demand (D.I.97). For the reasons that follow, the Motion to Strike TAP’s jury demand (D.I.97) will be granted, the Motion for Summary Judgment will be granted-in-part and denied-in-part, and the Motion to Exclude Expert Testimony of Thomas Dupont and Susan S. McDonald (D.I.91) will be granted-in-part and denied-in-part, such that Dr. Du-pont’s report and all testimony regarding his internet survey and Dr. McDonald’s testimony regarding her supplemental expert report will be excluded. All of the other motions will be denied.

II. BACKGROUND

A. Acid Reflux Disease

AstraZeneca and TAP both produce pharmaceuticals that work as proton pump inhibitors (“PPIs”) that treat Gastroeso-phageal Reflux Disease, commonly known as “acid reflux disease.” (D.I. 101 at 3.) AstraZeneca’s NEXIUM® (esomeprazole magnesium) and TAP’s PREVACID® (lansoprazole) compete with each other and other PPIs, as well as other pharmaceuticals and antacids. {Id.)

The main symptom of acid reflux disease is heartburn, a condition that causes a burning sensation in the chest when digestive acid backs up into the esophagus. (Declaration of Malcolm Robinson, 1 D.I. 110, Ex. D at ¶ 3.) Patients who suffer from acid reflux disease also may suffer from erosive esophagitis (“EE”), a condition that develops from excessive exposure of the esophagus to acid. (Declaration of David A. Johnson, 2 D.I. 90, Ex. K at ¶¶ 14- *282 15.) The only way to determine whether a patient has EE is to perform an upper gastrointestinal endoscopy, but such a procedure is usually only performed when a patient has symptoms such as bleeding, weight loss, chest pain, or difficulty in swallowing. (Robinson Decl., D.I. 110, Ex. D at ¶¶ 4-5.) Thus, a physician is often unaware of whether a patient has EE, and the general focus is on treating the symptoms of acid reflux disease. (Id.)

There are four grades of EE, generally measured according to two available scales. The Los Angeles scale divides EE sufferers on a scale of grades A-D, while the Hetzel-Dent scale uses grades 1-4. (Id. at ¶ 6.) Although comparisons are not precise, Grade 2 of the Hetzel-Dent scale is generally comparable to Grades A and B on the Los Angeles scale, Grade 3 compares with Grade C, and Grade 4 with Grade D. (Id. at ¶ 6.) EE which measures as Grades C or D on the Los Angeles scale, or as 3 or 4 on the Hetzel-Dent scale, is considered to be moderate to severe EE. (Id. at ¶ 7.)

B. The “Better Is Better” Advertising Campaign

AstraZeneca began a new direct-to-eon-sumer (“DTC”) marketing campaign for Nexium in September 2004. (See D.I. 1 at ¶ 7; D.I. 7 at ¶ 12.) That campaign, known as the “Better Is Better” campaign, ran until May 2005 and included two television commercials, print advertisements, website materials, and an informational pamphlet. The campaign claimed, among other things, that “recent medical studies ... prove Nexium heals moderate to severe acid related damage in the esophagus better than the other leading prescription medicine.” (D.I.l, Ex. B.) Those recent medical studies, known as the Castell and Fennerty studies (see infra section II.C.), show that Nexium healed patients with moderate to severe acid related damage in the esophagus better than Prevacid. (D.I.l, Ex. C.)

TAP, however, claims that the Better is Better advertising campaign is false. (D.I. 7 at ¶¶ 18-29.) TAP first asserts that the campaign is misleading because it claims that Nexium has been proven superior for the relief of symptoms such as heartburn and acid indigestion, when the Castell and Fennerty studies only show that Nexium was better at healing EE in patients with moderate to severe damage. (Id. at ¶¶ 22-23.) Next, TAP claims that the advertising campaign is literally false because Nexium is only marginally better at healing EE, and that difference is clinically meaningless. (Id. at ¶ 24.) TAP finally claims that, because only a small minority of patients who suffer from EE have moderate to severe EE, AstraZeneca’s claim that Nexium is better at healing EE is misleading to the majority of people who suffer from EE. (Id. at ¶ 25.)

C. Studies on Nexium and Prevacid

1. The Castell Study

The Castell Study, conducted by Dr. Donald O. Castell, 3 compared Prevacid 30 mg with Nexium 40 mg for healing of EE and resolution of heartburn. (Declaration of Donald O. Castell, D.I. 90, Ex. M at ¶ 6.) Prior to testing the study subjects, the investigators identified healing of EE at eight weeks as the primary endpoint for the study. (Id. at ¶ 10.) The study found that Nexium, with an overall healing rate *283 of 92.6%, was more effective than Preva-cid, with an overall healing rate of 88.8%, for healing EE after eight weeks of treatment, and that the difference was statistically significant. (Id. at ¶ 13.) Additional analysis of the results of the study showed that Prevacid was less effective as the severity of EE increased. (Id. at ¶ 15.) For Grades A and B, or mild, EE Nexium had a healing rate of 94.6%, while Prevacid had a healing rate of 93.8%. (Id.) However, for Grades C and D EE, Nexium had a healing rate of 86.6%, while Prevacid’s healing rate was 73.9%. (Id.) In fact, the differences in healing were 11.0% for Grade C EE, and 17.0% for Grade D. (Castell Paper, D.I. 90, Ex. V at 581.) Thus, the authors of the study concluded that Nexium was more effective than Pre-vacid at healing EE, and that “the difference in healing ... was most striking in patients with severe disease.” (Id.)

2. The Fennerty Study

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444 F. Supp. 2d 278, 2006 U.S. Dist. LEXIS 57410, 2006 WL 2338144, Counsel Stack Legal Research, https://law.counselstack.com/opinion/astrazeneca-lp-v-tap-pharmaceutical-products-inc-ded-2006.