In re Nexium (Esomeprazole) Antitrust Litigation
MEMORANDUM AND ORDER
I. INTRODUCTION
This case presents a multidistrict, putative class action against AstraZeneca AB, Aktiebolaget Hassle, and AstraZeneca LP (collectively, “AstraZeneca”), Ranbaxy Pharmaceuticals, Inc., Ranbaxy Inc. and Ranbaxy Laboratories, Ltd. (collectively, “Ranbaxy”); Teva Pharmaceutical Industries, Ltd. and Teva Pharmaceuticals USA, Inc. (collectively, “Teva”); and Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “Dr. Reddy’s”) (collectively, with Ranbaxy and Teva, the “Generic Defendants”) (collectively, with AstraZeneca, the “Defendants”) for alleged violations of federal antitrust laws involving
II. ANALYSIS
The Defendants raise many of the same challenges to the Direct Purchasers’ motion for class certification as they did against the End-Payors. Compare Defs.’ Opp’n Direct Purchasers Class Pis.’ Mot. Class Certification (“Defs.’ Opp’n”), ECF No. 377, with Defs.’ Mem. Law Opp’n End-Payor Pis.’ Mot. Class Certification (“Defs.’ End-Payor Mem.”), ECF No. 376. On November 14, 2013, the Court granted the End-Payors class certification. Mem. & Order, ECF No. 519. Noting that the same analysis applies with full force and effect to the Direct Purchaser class, the Court here focuses on those matters germane to the Direct Purchasers.
A. Rule 23(a)(1): Numerosity of the Class
In a motion for class certification, the moving party must establish the four threshold requirements under Rule 23(a). Wal-Mart Stores, Inc. v. Dukes, — U.S. -,
1. Class Below Forty Members
The expert for the named Direct Purchasers, Dr. Raymond Hartman, measures the putative class according to two “but-for” generic entry dates, April 14, 2008 and January 1, 2012, resulting in either thirty-one or twenty-six class members, respectively. Notice Filing Unredacted Copy Deck Raymond S. Hartman Supp. Certification Class Direct Purchasers Nexium, Ex. 1, Deck Raymond S. Hartman Supp. Certification Class Direct Purchasers Nexium (“Hartman Decl.”), ¶¶ 37, 65, ECF No. 401-1. The Court however, adopts the Defendants’ figures of twenty-nine or twenty-four members, which account for the consolidation of two entities with their parent corporations. Deck Thomas A. Isaacson Supp. Defs.’ Opp’n Direct Purchaser Class Pis.’ Mot. Class Certification (Dkt. No. 266), Ex. 1, Expert Report Dr. John H. Johnson, IV Direct Purchaser Class Certification, (“Johnson Rpt.”) ¶ 11 n. 11, ECF No. 356-1.
While the Defendants point out that this range falls well below the suggested threshold of forty members, Defs.’ Opp’n 8, (citing García-Rubiera v. Calderón,
The test for numerosity requires the Court to address the question of whether “joinder of all members is impracticable.”
2. Subjective Factors in Numerosity Analysis
Subjective factors such as the geographic location of proposed class members, the nature of the action, and matters of judicial economy must be taken into account in this inquiry. See 5 James Wm. Moore et al., Moore’s Federal Practice § 23.22[1][a]-[f] (3d ed. 1999) (listing subjective factors to consider when determining whether a class is sufficiently numerous); see also Meijer, Inc. v. Warner Chilcott Holdings Co. III,
The Court thus determines the numerosity requirement to have been sufficiently met under
As the Direct Purchaser plaintiffs have properly met the requirements under
B.
The Defendants do not challenge the competency of class counsel, and the record contains no evidence impugning their qualifications. See Linda S. Mullenix, Taking Adequacy Seriously: The Inadequate Assessment of Adequacy in Litigation and Settlement Classes, 57 Vand. L.Rev. 1687 (2004). Rather, the Defendants dispute whether assignees of direct purchaser claims can be included in the proposed class and serve as class representatives. Defs.’ Opp’n 20. Class representatives, of course, “must be part of the class.” Wal-Mart,
Ample precedent exists for the proposition that assignees can be adequate class representatives. This Court in In re Relafen Antitrust Litigation, involving a generic delay antitrust case, allowed drugstore plaintiffs, who were assignees of the claims of several wholesalers, to sue for overcharge damages.
Here, there is no reason to believe the actual assignments are invalid, nor does the Court find any evidence that ASC and Meijer do not share the same interests as the rest of the class (in fact, ASC also sues on behalf of itself as a direct purchaser). Direct Purchasers Compl. ¶ 19. Consistent with the case law of this Court and that of several other jurisdictions, the Direct Purchasers have fulfilled the requirements of
C.
The named Direct Purchasers seek class certification under
The key inquiry is “whether proposed classes are sufficiently cohesive to warrant adjudication by representation.” Amchem Prods., Inc. v. Windsor,
This Court must subject the proffered arguments and expert reports to rigorous scrutiny to determine whether the named Direct Purchasers present a “reasonable, judicially recognized methodology for calculating damages and [show] that the data needed to make these calculations is available and common to the class.” In re Neurontin Antitrust Litig., Nos. 02-1830(FSH),
As discussed in its End-Payors’ class certification analysis, this Court follows the legal standards outlined in Wal-Mart,
1. Common Proof of Antitrust Impact
Like the End-Payor plaintiffs, the named Direct Purchasers allege the Defendants “engineered an overarching scheme” of utilizing reverse payment agreements to delay generic entry, resulting in antitrust impact and injury to Nexium purchasers. Direct Purchasers Compl. If 5; Corrected Consol. Am. Class Action Compl. & Demand Jury Trial (“End-Payors’ Compl.”) ¶ 5, ECF No. 114. This Court agrees that each member of the putative Direct Purchaser class alleges the same claims arising from a “unified course of anticompetitive conduct;” namely, AstraZeneca’s lawsuits against its generic rivals and the resulting reverse payment agreements. Pis.’ Mem. 15-16. Here, the theory of liability for antitrust violations is straightforward, but establishing proof of common impact and damages requires a closer look to determine that all class members suffered common impact as a result of the Defendants’ actions.
The Court’s standard of review, as outlined in the End-Payors’ class certification analysis, see Mem. & Order 26-27, requires that the moving party demonstrate that “all class members were victims,” Wal-Mart,
must include some means of determining that each member of the class was in fact injured, even if the amount of each individual injury could be determined in a separate proceeding. Predominance is not defeated by individual damages questions as long as liability is still subject to common proof. This is because the class action can be limited to the question of liability, leaving damages for later individualized determinations.
In re New Motor Vehicles Canadian Export Antitrust Litig.,
The Direct Purchasers present common proof of antitrust impact in the form of overcharges. The Supreme Court has “long recognized [overcharges] as the principal measure of damages for plaintiffs injured as customers.” In re Relafen Antitrust Litig.,
a. Market Effect: Brand Erosion
“Generics are priced substantially below their branded counterparts and quickly capture sales from the brand,” id. at 17, and AstraZeneca, in its own internal forecasts, expected generic Nexium to have the same market effect. Hartman Decl. ¶ 32. AstraZ-eneca and the Generic Defendants are well-versed in this market phenomenon, as demonstrated by the Generic Defendants’ own “brand erosion” predictions and by AstraZ-eneca’s internal analyses and emails, estimating brand erosion of 90 percent within three
b. Generic Bypass Effect
Dr. Hartman calculates two sets of overcharge damages: $25,600,000,000 for a generic entry date in April 2008 and $8,200,000,000 for a generic entry date in January 2012. Id. at ¶¶ 62-66. These damages were calculated based on “yardstick” percentages, derived from sales data for Pre-vacid and its generic, lansoprazole, a similar proton pump inhibitor in the same category as Nexium. Id. at ¶ 61 (incorporating National Sales Perspective data from IMS Health, a vendor of pharmaceutical industry data). Overcharges were measured based on the number of units of Nexium purchased by direct purchasers during the class period, “regardless of whether some of those units would not have been purchased by those wholesalers during a period of earlier generic entry” due to “generic bypass.” Id. at ¶ 55.
Generic bypass — where generic manufacturers sell directly to end-purchasers and retailers, bypassing the wholesale level— was addressed by this Court in In re Relafen Antitrust Litig.,
Dr. Hartman states he was advised by the representative plaintiffs to assume the Court will rule that overcharge calculations need not account for generic bypass, although he is able to incorporate generic bypass into his model. Hartman Deck ¶ 57. The Defendants respond by pointing out that Dr. Hartman “offered no methodology to account for the varying extent of generic bypass ---- that would not require analysis for each individual direct purchaser.” Johnson Rpt. ¶ 43.
The Court draws the following conclusions. First, the issue of generic bypass primarily affects the measure of damages, a matter exclusively reserved to jury determination at trial. Second, this Court adheres to its ruling in In re Relafen that generic bypass cannot preclude recovery and that plaintiffs only need a “viable method” for demonstrating damages common to the class. In re Neurontin,
c. Variations in Sales Price and Use of Averages
The Defendants challenge both the assertion of common antitrust impact and Dr. Hartman’s methodologies by arguing that “fact of injury” requires individual inquiry into each class member’s “purchase strategies, volumes, and net prices.” Defs.’ Opp’n 14 (stating that plaintiffs’ common proof “must include some means of determining that each member of the class was in fact injured.”) (quoting In re New Motor Vehicles,
The average net price paid for each brand Nexium pill, during the proffered class period of August 27, 2008 to May 30, 2013, is calculated to be $4.42, with the highest average net price peaking at $5.41 per pill and the lowest average prices at $0.43 and $1.94 per pill, paid by DMS Pharmaceutical Group Inc. and Good Samaritan Hospital & Health, respectively. Johnson Rpt. ¶ 7, Ex. 6, Average Net Prices Nexium Direct Purchasers During Class Period. The Defendants use this range to argue that the two class members paying $0.43 and $1.94 per pill paid “far below the but-for generic price[s]” of “roughly $1.00 — 3.00/pill” and were thereby uninjured, defeating the predominance requirement. Defs.’ Opp’n 14. The Defendants’ expert, Dr. Johnson, further criticizes Dr. Hartman’s damages model for failing to account for the widely varying deductions and discounts received by direct purchasers from AstraZeneca. Johnson Rpt. ¶ 20. Thus, failing to account for chargebacks, rebates, and discounts “will directly cause actual net prices paid by direct purchasers to diverge from the average price used by Dr. Hartman.” Johnson Rpt. ¶23 (listing discounts ranging from 29 percent to 90 percent).
Moreover, the Defendants argue that averages are “inadequate” when “there is evidence that individual class members do not conform to the average.” Defs.’ Opp’n 16 (citing In re New Motor Vehicles,
Upon consideration of the parties’ expert reports and theories on brand erosion and generic bypass, this Court concludes that the Direct Purchasers are able to present a common impact theory at trial, and that at this stage of litigation, a showing of common impact has been satisfied. See supra section II.C.1.a. The Defendants’ focus on the variations in purchase price among the putative class members directly challenges the Direct Purchasers’ damages model, but it does not
As to the use of averages, Wal-Mart may have struck down the use of a “sample set” measurement,
The Court recognizes that uninjured direct purchasers may be included within the sweep of the proposed class, but emphasizes that the presence of uninjured class members is not fatal to class certification. See Mem. & Order 27 (“Several courts, however, have held that at this class certification stage of litigation, the inclusion of uninjured class members is not fatal to class certification.”). Class certification does not turn on whether a moving party has addressed all possible variations and nuances in its damages calculations. The Defendants, in their attempt to undercut Dr. Hartman’s damages model, rely too heavily on pointing out missing factors in the damages model, arguing that Dr. Hartman failed to account for differences among types of customers, buying power of individual wholesalers, regional preferences for Nexium, and individual purchase price. Johnson Rpt. ¶ 20-24. At this stage of litigation, the Court recognizes that while it must address “considerations that are enmeshed in the factual and legal issues comprising the plaintiffs cause of action,” Wal-Mart,
2. Common Proof of Damages
Finally, the Direct Purchasers address common proof of damages under the rubric of Comcast,
The Direct Purchasers present two preliminary damages calculations based on the April 2008 and January 2012 but-for generic entry dates, with damages continuing to accrue to class members. Pis.’ Mem. 19. First, they argue that Dr. Hartman’s “yardstick” methodology has been endorsed by the First Circuit, and district courts within this circuit, in numerous delayed-generie cases. Id. at 19 n. 67; Pls.’ Reply Brief 15 n. 56 (citing In re Pharm.,
The Defendants challenge this assertion by arguing that “common issues ... do not predominate when individualized inquiries are necessary” to measure varying damages among the class. Defs.’ Opp’n 17. Similar to their criticisms of the End-Payors’ expert methodology, see Defs.’ End-Payor Mem. 13-14, the Defendants point out that Dr. Hartman fails to account for actual brand prices, but-for generic prices, purchases by brand loyalists, and generic and other-drug conversion rates. Defs.’ Opp’n 17-18. For example, individual discounts to direct purchasers “ranged from less than 5% to more than 90%,” and the generic conversion rates of Dr. Hartman’s benchmark drug Prevacid ranged from “roughly 0% to 90%, depending upon the category of trade.” Defs.’ Opp’n 17-18. Less persuasive here are the Defendants’ arguments pointing to the potential inaccuracies in the but-for pricing of Nexium due to factors like brand-loyal purchases and conversion to other drugs. Id. These variations, the Defendants argue, are ignored by the use of averages calculations, see id. at 18, and without individualized inquiries, will result in the unlawful recovery of damages by uninjured direct purchasers.
The Court acknowledges that variation in actual price paid among the direct purchasers may preclude some class members from recovery if it is shown that various rebates, discounts, or buying practices did not result in net positive damages. At this stage, however, the Court looks to see whether the Direct Purchasers are able to show common damages with their proffered methodology. As with the End-Payors, the Direct Purchasers here advance a single, class-wide theory of harm: Defendants’ unlawful conduct delayed the entry of lower-priced generic Nexi-um, see Direct Purchasers Compl. ¶¶ 10-12, clearly differentiating this case from the facts in Comcast, which rejected a damages model because it failed solely to incorporate the court’s accepted theory of liability.
Here, two sets of common damages are calculated and presented under a reasonable and judicially acceptable methodology, based upon existing sales data by the identifiable direct purchasers and benchmarked against a similar drug, Prevacid, and its generic. The Direct Purchasers have thus met the requirement of proving common damages under
3. Superiority
Lastly, the Direct Purchasers address the second prong of
The Defendants’ counterarguments are powerful: they first point out that class members are economically well-suited for individual suits because of the “nearly $1 billion” in damages claimed per plaintiff. Defs.’
This is a close call. Even so, considering the complex nature of this litigation, the fact that complete joinder of the Direct Purchaser class is impracticable, and the “desirability” of concentrating litigation in this single forum,
III. CONCLUSION
Accordingly, this Court GRANTS the Direct Purchasers’ Motion for Class Certification under
SO ORDERED.
Notes
. The Defendants concede that the median purchase of Nexium by each of the members of the putative Direct Purchaser class exceeded $22,000,000. Defs.’ Opp’n 12.
. Pursuant to the Court’s order denying AstraZ-eneca and Ranbaxy’s motion for partial summary judgment, the Direct Purchasers’ claims, relating to Ranbaxy’s alleged exclusion from the market as a result of the AstraZeneca-Ranbaxy settlement agreement, are not yet time-barred under the four-year federal statute of limitations. Order, ECF No. 546.