Commonwealth v. Tap Pharmaceutical Products, Inc.

36 A.3d 1112, 2011 Pa. Commw. LEXIS 414
Commonwealth Court of Pennsylvania·Decided August 31, 2011·Published·Cited by 14 cases

Opinion

OPINION re POST-TRIAL MOTIONS of the COMMONWEALTH of PENNSYLVANIA and JOHNSON & JOHNSON DEFENDANTS

OPINION BY

Judge SIMPSON.

TABLE OF CONTENTS

I.BACKGROUND .1121

A. Opening.1121

B. Parties.1122

1. Plaintiff Agencies .1122

a. DPW/Pennsylvania Medicaid.1122

b. Department of Aging/P ACE.1123

2. Johnson & Johnson Defendants.1124

C. Procedural History.1126

II. FINDINGS AND CONCLUSIONS: INFLATED “PRICES”.1129

A WAC and AWP Generally.1129

B. AWP System and Confusion — Findings.1130
C. CPL Violation.1134
1. Tendency to Deceive.1134
2. Materiality.1134
3. ’’Government Knowledge”.1134

a. Generally.1134

b. ’’Government Knowledge” — Other Findings.1135

(1) Radke Testimony.1135

(2) Other DPW Evidence .1135

(3) PACE Evidence.1138

c. ’’Government Knowledge” — Conclusions.1139

4. Reliance/”Government Choice”.1139

a. Generally.■.1139

b. ’’Government Choice” — Findings .1140

[1120]*11205. Causation.1141

6. Restoration Amounts.1142

a. Generally.1142

b. Rebates — Findings.1142

D. Negligent Misrepresentation...1143
E. Conspiracy.1144

III. FINDINGS AND CONCLUSIONS: MARKETING THE SPREAD..1145

A. Procrit®.1145
B. Remicade® .1147
C. Conclusions.1148

IV.J & J GLOBAL CHALLENGE: JUDICIAL ESTOPPEL 3

A. Contentions.
B. Analysis.

V.J & J GLOBAL CHALLENGE: NON-JUSTICIABLE POLITICAL QUESTION . I — 1 cn to

A. Contentions H — 1 cn to
B. Analysis ... I — 1 cn Co

VI.J & J CHALLENGES TO CPL AWARDS .1157

A Plaintiff Agencies Not Consumers.1157

1. Contentions .1157
2. Analysis.1157
B. Challenge to Meaning and Application of ‘AWP’.1159
1. Contention.1159
2. Analysis.1160

a. ’’Plain Meaning” Construction of AWP .1160

b. Target Audience.1162

c. Sophisticated Parties.1162

d. Materiality.1164

e. Causation of Harm .1164

C. Injunction Improper .1164
1. Contentions .1164
2. Injunction Moot.1165
3. Injunction Unnecessary.1167

a. Contentions.1167

b. Standard for Injunction Under CPL .1167

c. Urgent Necessity.1169

4. First Amendment.1173
D. Restoration Improper.1175
1. Contentions .1175
2. Analysis — Generally.1175
3. No Basis for Injunction.1176
4. J & J Not “Acquire” Funds.1176
5. No Evidence of “Overpayment”.1176
6. Challenge to Warren-Boulton’s PBM Model.1177

a. Contentions.1177

b. Analysis Generally.1177

c. Global Challenges to “But For” Methodology.1178

d. Real-World Factors .1178

e. Improper Inclusions.1179

7. Restoration Before 1997.1179

a. Contentions.1179

b. Waiver.1179

E. Civil Penalties Improper.1179
1. Contentions .1179
2. Evidence of Willfulness .1180

[1121]*11213. Changes to NDCs.1180

VII. COMMONWEALTH DEMAND FOR JNOV.1181
A. Contentions.1181
B. Analysis.1182
1. Generally .1182
2. Negligent Misrepresentation.1183
3. Civil Conspiracy.1184
VIII. COMMONWEALTH DEMAND FOR NEW TRIAL .1185
A. Contentions.1185
B. Analysis.1186
IX. COMMONWEALTH DEMAND FOR MODIFICATION .1187
A. Contentions.1187
B. Analysis.1188
X. CONCLUSION.1190
I. BACKGROUND
A. Opening

This complex original jurisdiction action, which comes before a panel of this Court for a third time, involves the pricing of pharmaceuticals reimbursed by the Pennsylvania Department of Public Welfare (DPW), which administers Pennsylvania’s Medicaid program, and by the Department of Aging, which administers the Pharmaceutical Assistance Contract for the Elderly (PACE) program, based on Average Wholesale Price (AWP) between 1991 and 2008.

In particular, the Commonwealth, through its Attorney General, filed suit against numerous pharmaceutical companies, including defendant Johnson & Johnson and several of its current or former subsidiary operating companies1 (collectively, “Johnson & Johnson Defendants”), which, the Commonwealth claimed, engaged in improper conduct that caused DPW and PACE (collectively, “Plaintiff Agencies”) to pay inflated prices for pharmaceuticals the defendant pharmaceutical companies manufactured, marketed and sold. Among other things, the Commonwealth alleged the defendant pharmaceutical companies, including Johnson & Johnson Defendants, reported, or contributed to the reporting of, inflated AWPs for certain branded drugs which' are published in commercial publications. These inflated prices caused damages to DPW and PACE, which relied on these reported prices.

Central among the Commonwealth’s claims is that the published AWPs for Johnson & Johnson Defendants’ branded drugs are fictitious because they do not reflect an accurate average wholesale price charged by wholesalers to providers, including physicians and pharmacists.

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Commonwealth v. Tap Pharmaceutical Products, Inc., 36 A.3d 1112, 2011 Pa. Commw. LEXIS 414 (Pa. Ct. App. 2011).

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Com. v. TAP PHARMACEUTICAL PRODUCTS, INC.
36 A.3d 1112 (Commonwealth Court of Pennsylvania, 2011)