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Commonwealth v. Tap Pharm. Prods., Inc.

Document Cited authorities 114 Cited in 27 Precedent Map Related
Vincent
Citation36 A.3d 1197
CourtPennsylvania Commonwealth Court
Decision Date31 August 2011
PartiesCOMMONWEALTH of Pennsylvania, Plaintiff v. TAP PHARMACEUTICAL PRODUCTS, INC.; Abbott Laboratories; AstraZeneca PLC; AstraZeneca, Holdings, Inc.; AstraZeneca Pharmaceuticals LP; AstraZeneca LP; Bayer AG; Bayer Corporation; SmithKline Beecham Corporation d/b/a GlaxoSmithKline; Pfizer, Inc.; Pharmacia Corporation; Johnson & Johnson; Alza Corporation; Centocor, Inc.; Ethicon, Inc.; Janssen Pharmaceutical Products, L.P.; McNeil–PPC, Inc.; Ortho Biotech, Inc.; Ortho Biotech Products; L.P.; Ortho–McNeil Pharmaceutical, Inc; Amgen, Inc.; Immunex Corporation; Bristol–Myers Squibb Company; Baxter International Inc.; Baxter Healthcare Corporation; Immuno–U.S., Inc.; Aventis Pharmaceuticals, Inc.; Aventis Behring, L.L.C.; Hoechst Marion Roussel, Inc., Boehringer Ingelheim Corporation; Boehringer Ingelheim Pharmaceuticals, Inc.; Ben Venue Laboratories; Bedford Laboratories; Roxane Laboratories; Schering–Plough Corporation; Warrick Pharmaceuticals Corporation; Schering Sales Corporation; Dey, Inc., Defendants.

36 A.3d 1197

COMMONWEALTH of Pennsylvania, Plaintiff

v.TAP PHARMACEUTICAL PRODUCTS, INC.; Abbott Laboratories; AstraZeneca PLC; AstraZeneca, Holdings, Inc.; AstraZeneca Pharmaceuticals LP; AstraZeneca LP; Bayer AG; Bayer Corporation; SmithKline Beecham Corporation d/b/a GlaxoSmithKline; Pfizer, Inc.; Pharmacia Corporation; Johnson & Johnson; Alza Corporation; Centocor, Inc.; Ethicon, Inc.; Janssen Pharmaceutical Products, L.P.; McNeil–PPC, Inc.; Ortho Biotech, Inc.; Ortho Biotech Products; L.P.; Ortho–McNeil Pharmaceutical, Inc; Amgen, Inc.; Immunex Corporation; Bristol–Myers Squibb Company; Baxter International Inc.; Baxter Healthcare Corporation; Immuno–U.S., Inc.; Aventis Pharmaceuticals, Inc.; Aventis Behring, L.L.C.; Hoechst Marion Roussel, Inc., Boehringer Ingelheim Corporation; Boehringer Ingelheim Pharmaceuticals, Inc.; Ben Venue Laboratories; Bedford Laboratories; Roxane Laboratories; Schering–Plough Corporation; Warrick Pharmaceuticals Corporation; Schering Sales Corporation; Dey, Inc., Defendants.

Commonwealth Court of Pennsylvania.

Argued May 9, 2011.Decided Aug. 31, 2011.

OPINION TEXT STARTS HERE

Donald E. Haviland, Jr., Philadelphia, and William O. Crutchlow, Edison, NJ, for plaintiff.

Allen S. Loney, Jr., Philadelphia, Steven M. Edwards, New York, NY, and Michael C. Moore, Dallas, TX, for defendant Bristol–Myers Squibb.

Jack Mentzer Stover, Harrisburg, for defendants Bristol–Myers Squibb and Johnson & Johnson.BEFORE: LEADBETTER, President Judge, and SIMPSON, Judge (P), and FEUDALE, Senior Judge.

OPINION re POST–TRIAL MOTIONS of the COMMONWEALTH of PENNSYLVANIA and BRISTOL–MYERS SQUIBB COMPANY

OPINION BY Judge SIMPSON.

+-----------------+
                ¦TABLE OF CONTENTS¦
                +-----------------+
                
                I.     BACKGROUND                                                    1210
                
      A.    Opening                                                  1210
                      B.    History                                                  1211
                
            1.    Average Wholesale Price—Origin & Evolution         1211
                            2.    Plaintiff Agencies                                 1214
                
                a.    DPW/Pennsylvania Medicaid                     1214
                                b.    Department of Aging/PACE                      1215
                
            3.    BMS                                                1216
                
      C.    Procedural History                                       1216
                
                II.    BMS' CHALLENGE TO STATUTORY                                   1219
                       INJUNCTION
                
      A.    Summary of BMS' Argument                                 1219
                      B.    Sufficiency of Evidence                                  1220
                
            1.    Contentions                                        1220
                            2.    Analysis                                           1220
                
      C.    Alleged Irreparable Harm to Others                       1223
                
            1.    Alleged Irreparable Harm to Innocent Third Parties 1223
                
                a.    Contentions                                   1223
                                b.    Analysis                                      1224
                
                       i.   Waiver                                   1224
                                       ii.  Failure of Proof                         1225
                                       iii. Modification of Injunction               1225
                                       iv.  Failure of Legal Support                 1226
                
            2.    Alleged Procedural Defect                          1228
                
                a.    Contentions                                   1228
                                b.    Analysis                                      1228
                
            3.    Alleged Interference with Statutory/ Regulatory    1229
                                  Schemes
                
                a.    Contentions                                   1229
                                b.    Analysis                                      1230
                
            4.    Alleged Irreparable Harm to BMS                    1231
                
                a.    Contentions                                   1231
                                b.    Analysis                                      1231
                
            5.    Alleged Commerce Clause Violation                  1233
                
                a.    Contentions                                   1233
                                b.    Analysis                                      1233
                
            6.    Balancing the Harm                                 1235
                
                a.    Contentions                                   1235
                                b.    Analysis                                      1235
                
      D.    Alleged Lack of Urgent Necessity                         1236
                
            1.    Alleged Inconsistency in the Decision              1236
                
                a.    Contentions                                   1236
                                b.    Waiver                                        1236
                                c.    Standard for Injunction under CPL             1236
                                d.    Urgent Necessity                              1238
                
            2.    Alleged Lack of Ongoing Injury                     1243
                
                a.    Contentions                                   1243
                                b.    Analysis                                      1244
                
            3.    Alleged Failure to Provide Meaningful Relief       1244
                
                a.    Contentions                                   1244
                                b.    Analysis                                      1245
                
                       i.   Waiver                                   1245
                                       ii.  AWP Confusion                            1245
                                       iii. OIG Reports, Surveys and Price Audits    1249
                                       iv.  AMPs and ASPs                            1249
                                       v.   Conclusion                               1249
                
            4.    Alleged Harm Compensable by Monetary Damages       1250
                
                a.    Contentions                                   1250
                                b.    Analysis                                      1250
                
      E.    Alleged Lack of Clear Right to Relief                    1251
                
            1.    Alleged Inconsistency with Jury Verdict            1251
                
                a.    Contentions                                   1251
                                b.    Analysis                                      1252
                
            2.    Alleged Lack of Fraudulent or Deceptive Conduct    1255
                
                a.    Contentions                                   1255
                                b.    Analysis                                      1255
                
            3.    Alleged Inconsistency of Decision with MDL 2007    1256
                                  Opinion
                
                a.    Contentions                                   1256
                                b.    Analysis                                      1257
                
            4.    Alleged Lack of Proof of Overpayment               1259
                
                a.    Contentions                                   1259
                                b.    Analysis                                      1260
                
            5.    Alleged Lack of Proof of Spread Marketing          1261
                
                a.    Contentions                                   1261
                                b.    Analysis                                      1261
                
                III.   BMS' CHALLENGE TO STATUTORY                                   1262
                       RESTORATION
                
      A.    Alleged Lack of Statutory Basis for Restoration          1262
                
            1.    Contentions                                        1262
                            2.    Analysis                                           1263
                
      B.    Alleged Inconsistency with Dismissal of Unjust           1264
                            Enrichment Claim
                
            1.    Contentions                                        1264
                            2.    Analysis                                           1264
                
      C.    Alleged Absence of Overpayment                           1265
                
            1.    Contentions                                        1265
                            2.    Analysis                                           1265
                
      D.    Alleged Flawed Damage Estimate                           1266
                
            1.    BMS Contentions                                    1266
                
                a.    Drugs Not in the Case                         1266
                                b.    Challenge to “But For” Methodology            1266
                                c.    Rebates                                       1266
                
            2.    Analysis                                           1267
                
                a.    Generally                                     1267
                                b.    Drugs Not in the Case                         1267
                                c.    Challenge to “But For” Methodology            1268
                                d.    Rebates                                       1269
                
      E.    Alleged Inconsistency with Jury Verdict                  1269
                
            1.    Contentions                                        1269
                            2.    Analysis                                           1269
                
      F.    Alleged Impropriety of Award in Suit on behalf of DPW    1270
                            and PACE
                
            1.    Contentions                                        1270
                            2.    Analysis                                           1271
                
                IV.    OTHER EVIDENTIARY ISSUES                                      1273
                V.     BMS' REQUEST FOR STAY                                         1273
                
      A.    Generally                                                1273
                      B.    Likely to Prevail on Merits                              1273
                      C.    Irreparable Injury without Stay                          1274
                      D.    Stay Not Harm Other Parties                              1275
                      E.    Stay Not Adversely Affect Public                         1275
                      F.    Conclusion                                               1275
                
                VI.    COMMONWEALTH'S CHALLENGE TO                                   1275
                       VERDICT ON COMMON LAW CLAIMS
                
      A.    Standards for Analyzing Motions for JNOV and New Trial   1275
                            Elements of Negligent Misrepresentation Claim/Section
                      B.
...

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22 cases
  • Commonwealth v. Tap Pharm. Prods., Inc.
    • United States
    • Pennsylvania Commonwealth Court
    • August 31, 2011
    ...how, if at all, a “whatever the pharmaceutical company was reporting consistent with industry standards and expectations when the AWP [36 A.3d 1197] statute was enacted [1994]” analysis will take into account new generations or classes of drugs developed thereafter. These circumstances were......
  • Pennsylvania v. Navient Corp.
    • United States
    • U.S. District Court — Middle District of Pennsylvania
    • December 17, 2018
    ...may consider whether the offending conduct is likely to reoccur absent the grant of an injunction. Commonwealth v. TAP Pharm. Products, Inc. , 36 A.3d 1197, 1238-43 (Pa. Commw. Ct. 2011) (also noting that the CPL is modeled on the FTC Act), vacated on other grounds , 626 Pa. 1, 94 A.3d 350 ......
  • Wash. Cnty. Bd. of Educ. v. Mallinckrodt Ard, Inc.
    • United States
    • U.S. District Court — District of Maryland
    • January 3, 2020
    ...2007), aff'd , 582 F.3d 156 (1st Cir. 2009) ; Watson Labs., Inc. v. State , 241 So. 3d 573, 578 (Miss. 2018) ; Com. v. TAP Pharm. Prod., Inc. , 36 A.3d 1197 (Pa. Commw. Ct. 2011), vacated on other grounds , 626 Pa. 1, 94 A.3d 350 (2014) ; State v. Abbott Labs. , 341 Wis.2d 510, 816 N.W.2d 1......
  • Gregg v. Ameriprise Fin., Inc.
    • United States
    • Pennsylvania Supreme Court
    • February 17, 2021
    ...in order to succeed on their CPL claim. Gregg v. Ameriprise Fin., 195 A.3d 930, 936 (Pa. Super. 2018). Applying Commonwealth v. TAP Pharm. Products, Inc. , 36 A.3d 1197 (Pa. Cmwlth. 2011), rev'd on other grounds , 626 Pa. 1, 94 A.3d 350 (2014), the Superior Court held that the test for dece......
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