In re Niaspan Antitrust Litig.
| Decision Date | 02 June 2020 |
| Docket Number | MASTER FILE NO. 13-MD-2460,MDL NO. 2460 |
| Citation | 464 F.Supp.3d 678 |
| Parties | IN RE: NIASPAN ANTITRUST LITIGATION This Document Relates to: All Actions |
| Court | U.S. District Court — Eastern District of Pennsylvania |
TABLE OF CONTENTS
II. BACKGROUND...688
III. MOTION TO EXCLUDE THE EXPERT TESTIMONY OF LAURA CRAFT AND ERIC MILLER...691
IV. EPPS’ MOTION FOR CLASS CERTIFICATION...697
V. EPPS’ MOTION TO EXCLUDE THE OPINIONS AND TESTIMONY OF JOHN F. FRITZ...725
I. INTRODUCTION
This multidistrict litigation involves what has come to be known as a "pay-for-delay," or "reverse payment," settlement—a practice in which a brand-name drug manufacturer brings a patent-infringement action against a generic drug manufacturer and then compensates the generic drug manufacturer for its agreement to delay entering the market with a competing generic version of the brand-name drug. In this case, two putative classes—the Direct-Purchaser Plaintiffs ("DPPs") and the End-Payor Plaintiffs ("EPPs")—aver that the brand-name manufacturer of the drug Niaspan, Kos Pharmaceuticals, Inc. ("Kos"), entered into anticompetitive settlement agreements with the generic manufacturer of that drug, Barr Pharmaceuticals, Inc. ("Barr"), in March of 2005 in order to terminate patent-infringement litigation brought by Kos against Barr in the District Court for the Southern District of New York. Kos was later acquired by defendant AbbVie Inc. ("AbbVie"), and Barr was later acquired by defendant Teva Pharmaceuticals, Inc. ("Teva").
Presently before the Court are End-Payor Plaintiffs’ Motion for Class Certification, Defendants’ Motion to Exclude the Expert Testimony of Laura Craft and Eric Miller Offered in Support of End-Payor Plaintiffs’ Motion for Class Certification, and End-Payor Plaintiffs’ Motion to Exclude the Opinions and Testimony of John F. Fritz.
For the reasons that follow, (1) Defendants’ Motion to Exclude the Expert Testimony of Laura Craft and Eric Miller is denied, (2) EPPs’ Motion for Class Certification is denied without prejudice, and (3) EPPs’ Motion to Exclude the Opinions and Testimony of John F. Fritz is denied as moot.
II. BACKGROUND
The background of this case is set forth in detail in the Court's Memorandum and Order of September 5, 2014. See In re Niaspan Antitrust Litig. , 42 F. Supp. 3d 735 (E.D. Pa. 2014). This Memorandum recites only the facts and procedural history relevant to the motions presently before the Court.
Defendant AbbVie, a drug manufacturer that was spun off from Abbott Laboratories ("Abbott") in January 2013, manufactures and sells Niaspan, a brand-name prescription drug, primarily used in the treatment of lipid disorders
. In the early 1990s, Kos, acquired by AbbVie in December 2006, developed a therapeutically-effective time-release version of niacin, which does not cause the side effects previously associated with niacin. Kos obtained a series of U.S. patents on time-release niacin and marketed the drug using the trademark Niaspan. Niaspan has been manufactured and sold by AbbVie (and AbbVie's predecessor corporations) since September of 1997.
In October 2001, Barr, acquired by Teva in January 2009, filed an Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration ("FDA") seeking authorization to manufacture and sell a generic equivalent of certain dosages of Niaspan. The ANDA process provides for streamlined FDA approval of a bioequivalent generic version of an FDA-approved brand-name drug. As part of the ANDA process, Barr filed certifications with the FDA stating that its generic drug did not infringe any of the patents covering Niaspan and/or that the patents were invalid or unenforceable.
In March 2002, Kos initiated the first of a series of patent-infringement lawsuits against Barr in the Southern District of New York, alleging infringement of its Niaspan patents. After three years of litigation, on April 12, 2005, Kos and Barr entered into several related settlement agreements terminating the litigation. These agreements constitute the alleged "pay-for-delay" or "reverse payment" settlement that is the subject of this litigation.
EPPs allege that defendants’ conduct violated the antitrust laws of 16 states, the consumer protection laws of 5 states, the unfair trade practices laws of 7 states, and the unjust enrichment laws of 25 states—a total of 53 state laws from 26 jurisdictions. See Defs.’ Opp'n to EPPs’ Mot. for Class Certification ( ) 3; Defs.’ Apps. State L. Supp. Defs.’ Opp'n to EPPs’ Mot. for Class Certification ( ) A1-1–A1-4. Specifically, EPPs claim that as a result of the alleged unlawful reverse payment settlement, putative class members "were denied the opportunity to purchase generic Niaspan before September 20, 2013, and were further denied the benefit of the price competition that would have ensued in a competitive environment where Kos launched an authorized generic Niaspan to compete with Barr during the 180-day exclusivity period."1 Mem. L. Supp. EPPs’ Mot. for Class Certification ("EPPs’ Mot. Class Cert") 12.
On December 19, 2018, EPPs filed a Motion for Class Certification. In their motion, EPPs seek certification of an overcharges class and an unjust enrichment class, each with two subclasses, a third party payor ("TPP") and a consumer subclass:
• Third Party Payor ("TPP") Overcharges Sub-class Definition:
• All entities in the United States and its territories who purchased, paid, and/or provided reimbursement for some or all of the purchase price for Niaspan and/or generic versions of Niaspan in Arizona, California, Florida, Iowa, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, North Dakota, Oregon, Rhode Island, Tennessee, Vermont, West Virginia, and Wisconsin for consumption by their members, employees, insureds, participants, or beneficiaries during the period April 3, 2007 through January 31, 2018 (the "Overcharges Class Period").
• Consumer Overcharges Sub-class Definition:
• All persons in the United States and its territories who purchased, paid, and/or provided reimbursement for some or all of the purchase price for Niaspan and/or generic versions of Niaspan in Arizona, California, Florida, Iowa, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, North Dakota, Oregon, Rhode Island, Tennessee, Vermont, West Virginia, and Wisconsin for consumption by themselves or their families during the period April 3, 2007 through January 31, 2018 (the "Overcharges Class Period").
• TPP Unjust Enrichment Sub-class Definition:
• All entities in the United States and its territories who purchased, paid, and/or provided reimbursement for some or all of the purchase price for Niaspan and/or generic versions of Niaspan in Alabama, Arizona, Florida, Iowa, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Oregon, Rhode Island, Tennessee, Utah, Vermont, West Virginia, Wisconsin, and Wyoming for consumption by their members, employees, insureds, participants, or beneficiaries during the period April 3, 2007 through September 19, 2013 (the "Unjust Enrichment Class Period").
• Consumer Unjust Enrichment Sub-class Definition:
• All persons in the United States and its territories who purchased, paid, and/or provided reimbursement for some or all of the purchase price for Niaspan and/or generic versions of Niaspan in Alabama, Arizona, Florida, Iowa, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Oregon, Rhode Island, Tennessee, Utah, Vermont, West Virginia, Wisconsin, and Wyoming for consumption by themselves or their families during the period April 3, 2007 through September 19, 2013 (the "Unjust Enrichment Class Period").
• Excluded from Overcharges and Unjust Enrichment Classes:
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