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In re Flonase Antitrust Litigation

United States District Court, Third Circuit

June 19, 2013

SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE plc, Defendant. THIS DOCUMENT RELATES TO Indirect Purchaser Actions MEDICAL MUTUAL OF OHIO, on behalf of itself and all others similarly situated, Plaintiff,



Following nearly five years of antitrust class action litigation between the makers of branded Flonase nasal spray, the makers of a generic brand version, indirect purchasers of the drug, and direct purchasers, the parties reached a global settlement in January 2013. Before me now is the Indirect Purchaser Plaintiffs’ (“IPPs”) Motion for Final Approval of Settlement (Doc. No. 574). After holding a fairness hearing on June 3, 203 and reviewing post-hearing submissions, I will now approve the final settlement agreement and allocation plan. I will also grant counsel’s request for attorneys’ fees, reimbursement of expenses, and incentive awards for class representative.

I. Background

Named plaintiffs A.F. of L.-A.G.C. Building Trades Welfare Plan (“AFL”), IBEW-NECA Local 505 Health & Welfare Plan (“IBEW”), Painters District Council No. 30 Health & Welfare Fund (“Painters”), and Andrea Kehoe (“Kehoe”), collectively “Indirect Purchasers, ” are indirect purchasers of the prescription drug Flonase and its generic equivalent. Flonase is the brand-name version of fluticasone propionate (“FP”), a nasal corticosteroid used to treat nasal inflammation caused by allergies and manufactured by Defendant SmithKline Beecham Corp., d/b/a GlaxoSmithKline PLC (“GSK”). Indirect Purchasers allege that GSK filed sham citizen petitions with the Food and Drug Administration to delay the entry of a cheaper, generic version of Flonase into the market, resulting in overcharges to the indirect purchasers.

This case has an extensive litigation history. The first Indirect Purchaser complaint was filed against GSK in July 2008.[1] Extensive discovery began in late 2008 and continued through mid-2010, including 30 depositions of current and former employees of GSK and Roxane Laboratories (“Roxane”), the maker of generic FP. Over a dozen expert reports and rebuttals were submitted. After extensive oral argument, I certified a class of indirect purchasers defined as follows:

A. With respect to the monopolization and UDTP claims

(1) For the Class Period from August 2004 through March 2006
All persons or entities throughout the United States and its territories who from August 2004 through March 2006 purchased, paid for, and/or reimbursed for branded Flonase in any of the following four states— Arizona, Florida, Massachusetts, or Wisconsin. These persons or entities must have also purchased, paid for, and/or reimbursed for an AB-rated generic fluticasone propionate nasal spray equivalent of branded Flonase (“generic FP”) from March 2006 to March 2009 in the same designated state in which the Flonase purchase was made.
(2) For the Class Period from March 2006 through March 2009
All persons or entities throughout the United States and its territories who from March 2006 to March 2009 purchased, paid for, and/or reimbursed for generic FP in the following states—Arizona, Florida, Massachusetts, or Wisconsin.

B. With respect to the unjust enrichment claims

(1) All persons or entities throughout the United States and its territories who from August 2004 through March 2006 purchased, paid for, and/or reimbursed for branded Flonase in any of the following three states— Arizona, Massachusetts, or Wisconsin. These persons or entities must have also purchased, paid for, and/or reimbursed for generic FP from March 2006 to March 2009 in the same designated state in which the Flonase purchase was made.

C. For purposes of the class definition, the Flonase and/or generic FP drugs must have been intended for consumption by the class members, their families or their members, employees, plan participants, beneficiaries, or insureds.

D. The following are excluded from the class:

(1) GSK and its respective subsidiaries and affiliates;
(2) all governmental entities (except for government funded employee benefit plans);
(3) all persons or entities that purchased FP nasal spray, including Flonase, for purposes of resale or directly from GSK to the extent and solely to the extent of such purpose for resale or as a direct purchase;
(4) insured individuals covered by plans imposing a flat dollar co-pay that was the same dollar amount for generic as for brand name drug purchases;
(5) fully insured health plans, i.e. plans that purchased insurance from another third-party payor covering 100% of the plan's reimbursement obligations to its members; and
(6) insured individuals who purchased only generic FP (never branded Flonase) and whose health plans imposed a flat dollar co-pay applicable to generic drugs.

In re Flonase Antitrust Litig., 284 F.R.D. 207, 216 (E.D. Pa. 2012).

In 2011, I denied two separate GSK motions for summary judgment, one on causation, and one on Noerr-Pennington immunity. See 798 F.Supp.2d 619 (E.D. Pa. 2011) and 795 F.Supp.2d 300 (E.D. Pa. 2011), respectively. The case was set for trial in early 2013, and both sides submitted over a dozen motions in limine. After extensive and vigorous settlement negotiations conducted by me in my chambers, over the course of multiple days, the parties reached a settlement agreement in November 2012, whereby GSK agreed to pay $46 million in exchange for the settlement of all indirect purchaser claims. That total includes an $11 million initial payment to a group of large health insurers (described below as the “SHPs”) and a $35 million payment for the remainder of the Indirect Purchaser Class. I preliminarily approved the settlement on January 14, 2013.

II. Final Approval of Settlement

According to Federal Rule of Civil Procedure 23(e), “The claims, issues, or defenses of a certified class may be settled, voluntarily dismissed, or compromised only with the court’s approval.” In other words, “a class action cannot be settled without the approval of the court and a determination that the proposed settlement is ‘fair, reasonable and adequate.’ ” In re Prudential Ins. Co. of Am. Sales Practice Litig., 148 F.3d 283, 316 (3d Cir.1998) (quoting In re G.M. Corp. Pick–Up Truck Fuel Tank Prods. Liab. Litig., 55 F.3d 768, 785 (3d Cir.1995)).

The Third Circuit applies a nine prong test, known as the Girsh factors, when determining the fairness, adequacy, and reasonableness of a proposed class action settlement:

(1) the complexity, expense and likely duration of the litigation; (2) the reaction of the class to the settlement; (3) the stage of the proceedings and the amount of discovery completed; (4) the risks of establishing liability; (5) the risks of establishing damages; (6) the risks of maintaining the class action through the trial; (7) the ability of the defendants to withstand a greater judgment; (8) the range of reasonableness of the settlement fund in light of the best possible recovery; (9) the range of reasonableness of the settlement fund to a possible recovery in light of all the attendant risks of litigation.

Girsh v. Jepson, 521 F.2d 153, 157 (3d Cir.1975) (internal quotation marks and ellipses omitted). In more recent decisions, the Third Circuit has suggested an expansion of the nine-prong test when appropriate to include what are now referred to as Prudential considerations, such as:

the maturity of the underlying substantive issues, as measured by experience in adjudicating individual actions, the development of scientific knowledge, the extent of discovery on the merits, and other facts that bear on the ability to assess the probable outcome of a trial on the merits of liability and individual damages; the existence and probable outcome of claims by other classes and subclasses; the comparison between the results achieved by the settlement for *335 individual class or subclass members and the results achieved-or likely to be achieved-for other claimants; whether class or subclass members are accorded the right to opt out of the settlement; whether any provisions for attorneys’ fees are reasonable; and whether the procedure for processing individual claims under the settlement is fair and reasonable.

In re Prudential, 148 F.3d at 323; see also In re Pet Food Prods. Liab. Litig., 629 F.3d 333, 350 (3d Cir.2010). District courts “must make findings as to each of the Girsh factors, and the Prudential factors where appropriate, ” and “cannot substitute the parties’ assurances or conclusory statements for [their] independent analysis of the settlement terms.” In re Pet Food. 629 F.3d at 350–51.

Here, the Girsh factors and relevant Prudential considerations weigh in favor of settlement approval.

A. The Complexity, Expense, and Likely Duration of the Litigation

This suit involves highly complex antitrust issues, FDA bioequivalence standards for suspension nasal spray products, pharmaceutical manufacturing and supply issues, and pharmaceutical regulatory issues, all of which were investigated and litigated for more than four years. Antitrust class actions are particularly complex to litigate and therefore quite expensive. See In re Auto. Refinishing Paint Antitrust Litig., 2008 U.S. Dist. LEXIS 569, at *14 (E.D. Pa. Jan. 3, 2009) (“This litigation, like most antitrust cases, has been exceedingly complex, expensive, and lengthy.”) (emphasis added). “ ‘An antitrust class action is arguably the most complex action to prosecute. . . .’ ” In re Linerboard Antitrust Litig., 296 F.Supp.2d 568, 577 (E.D.Pa.2003) (quoting In re Motorsports Merchandise Antitrust Litig., 112 F.Supp.2d 1329, 1337 (N.D.Ga.2000)). The DPs and GSK reached this settlement after they had completed significant preparation for trial, including litigating Daubert challenges, identifying hundreds of trial exhibits, and briefing over a dozen motions in limine between them. The settlement avoided the need for a difficult and expensive multi-week trial involving complex scientific and regulatory testimony, and the time and expense associated with the appeal that would likely have followed a verdict. This factor strongly supports settlement.

B. The Reaction of the Class to the Settlement

Class counsel developed the notice plan in close consultation with the Settlement Administrator, Rust Consulting, Inc. and its legal notice affiliate, Kinsella Media LLC. After I preliminarily approved the settlement, a Postcard Notice was sent via USPS First Class mail to the Third Party Payor (“TPPs”) members of the class, using Rust Consulting’s proprietary list of roughly 40, 000 addresses for TPPs and their agents. In addition, a notice was published in a variety of national publications that were specifically selected to reach the age and gender targets most representative of Flonase users. Notice also appeared in an insert in newspapers and periodicals in the U.S. Territories, and a TPP notice appeared in an industry trade journal. Finally, targeted internet banner ads were published for 30 days. Through this notice plan, it was estimated that 80 percent of medication users were able to see the notice.

The reaction of the class has been overwhelmingly positive. As of March 22, 2013, 8, 065 consumer claim forms had been downloaded from the website. By May 28, 2013, 251 TPP Proofs of Claim with a value of nearly $750 million and 1, 908 Consumer Proofs of Claim with a value of nearly $900, 000 have been filed. Only one consumer requested exclusion from the class, though his exclusion does not appear related to the merits of the settlement. See Decl. of Marvin Miller in Further Support of Plaintiffs’ Motion for Final Approval at 2, Doc. No. 591. Two consumer objections were filed on the deadline for objections.[2] Both raise nearly identical objections: (1) that the notice is unclear and difficult to understand; (2) that the class representative awards are excessive; and (3) that the attorneys’ fees are excessive. However, I will strike both objections because neither objection contained any proof whatsoever that the objector was actually a member of the class.

The notice that was approved in my preliminary approval order informs class members that they must file with their objection proof of membership in the class. See Doc. No. 570, Attachment 1 at 8-9. Jill Jan, who does not appear to be a licensed attorney, purported to file an objection on behalf of her son Hondo Jan, who was a minor during the class period but who now appears to be of majority age.[3] Jan declares that she had prescriptions of Flonase filled for Hondo in 2004-2005, and stated that she “made purchases” of Flonase at Rite Aid, Walgreens, and Longs. However, she provides no proof except for a doctor’s note dated October 3, 2003— before the class period—referring to Flonase as a “current medication” of Hondo’s. Jan Objection Ex. A. The Payton objection includes even less: a simple declaration from Payton that he was “prescribed and was taking the medication, Flonase” and that he was “insured through Kaiser during 2004 and 2009 and co-pays were required.” He does not state that he purchased Flonase, or that the purchasers were made during the relevant class period, let alone provide receipts that would establish class membership. Because neither objection demonstrates that the objector is actually a member of the class, I will strike those objections.[4]

Even if I were to consider Jan’s and Payton’s objections to the class notice on the merits, I still find that notice was reasonable and that the reaction of the class weighs in favor of approval of the settlement. Both Jan and Payton objects that the notice is unclear because it does not explain what specific benefit each individual can expect to receive. Here, the notice adequately explained that class members will receive a pro rata share of the net settlement fund. More specific figures cannot be provided, because it depends on how many individuals file claims, and what share of the total relevant purchases each individual’s relevant purchases represent. In this settlement, every dollar of the net settlement fund will be distributed to the class; the exact figure, however, cannot be determined until all the claims have been submitted and processed.

In sum, even if the objections are considered, the reaction of the class to the settlement agreement has been overwhelmingly positive, with only one exclusion and two objections. These objections are procedurally deficient; moreover, their substantive complaints about the notice are meritless. Therefore, this factor counsels in favor of approval of the settlement.

C. The Stage of the Proceedings and the Amount of Discovery Completed

These proceedings advanced to a sufficiently late stage prior to settlement that the related Girsh and Prudential factors also weigh in favor of approval. Explaining the rationale behind the third Girsh factor, the Third Circuit wrote in Prudential:

The parties must have an “adequate appreciation of the merits of the case before negotiating.” To ensure that a proposed settlement is the product of informed negotiations, there should be an inquiry into the type and amount of discovery the parties have undertaken.

In re Prudential, 148 F.3d at 319 (quoting In re G.M., 55 F.3d at 813). Further, “courts generally recognize that a proposed class action settlement is presumptively valid where . . . the parties engaged in arm’s length negotiations after meaningful discovery.” Cullen v. Whitman Med Corp., 197 F.R.D. 136, 144-45 (E.D. Pa. 2000).

This factor also weighs strongly in favor of approval of the settlement agreement. This case was very advanced by the time the agreement was reached. Fact discovery concluded in February 2010 and included 45 depositions and millions of pages of documents. Expert discovery concluded in September 20110 and included the exchange of numerous expert reports. The parties briefed two separate motions for summary judgment. The Court heard Daubert motions concerning experts on both sides on two separate occasions. By the time the agreement was reached, the parties had exchanged trial witness lists, conferred on trial exhibits and deposition testimony to be used at trial, and submitted pretrial memoranda. Trial was just two months away when the parties reached their agreement.

D. The Risks of Establishing Liability and Damages.

These two Girsh factors are closely related, so I will address them together. This case involved complex scientific, regulatory, and legal issues, and plaintiffs faced many obstacles to success at trial. Among other things the Plaintiff would have to prove were two particularly difficult propositions: First, they would have had to prove that GSK’s petitions to the FDA regarding generic FP were objectively baseless and that GSK could not have reasonably expected success on the merits of any of its requests to the FDA. Second, and most crucially, Plaintiffs would have had to prove that GKS’s petitions to the FDA were a substantial cause of any delay in the approval of Roxane’s generic FP, and that, but for GSK’s actions, Roxane would have had the manufacturing capability to get its product to market sooner. These difficulties go both to Plaintiffs’ case for liability and their case for damages, as they would have had to show that GSK’s actions resulted in improper overcharges to the DPs. After facilitating these extensive settlement negotiations, I can attest to the challenges Plaintiffs would have faced in ...

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