Shire US, Inc. v. Allergan, Inc.
This text of 375 F. Supp. 3d 538 (Shire US, Inc. v. Allergan, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
John Michael Vazquez, U.S.D.J.
This matter concerns antitrust allegations in the Medicare Part D ("Part D") prescription drug market. D.E. 64. Plaintiff, Shire US, Inc. ("Shire"), alleges that Defendants are engaged in an "ongoing, overarching, and interconnected scheme" to systematically block Plaintiff from competing with Defendants in the Part D prescription drug market for treatment of dry eye disease in violation of Sections 1 and 2 of the Sherman Act and state law. D.E. 64 ¶¶ 1, 25. Defendants consist of Allergan, Inc.; Allergan Sales, LLC; and Allergan USA, Inc. (collectively "Defendants" or "Allergan"). The present matter comes before the Court on Defendants' motion to dismiss Plaintiff's First Amended Complaint ("FAC") for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6). D.E. 14. The Court reviewed all submissions1 and held oral argument on February 26, 2019. For the reasons that follow, Defendants' motion to dismiss is granted.
I. BACKGROUND2
Plaintiff Shire alleges that Allergan is coercing Part D prescription drug plans to effectively exclude Shire's superior dry eye disease ("DED") treatment drug from the market through a combination of anticompetitive bundling and exclusive dealing arrangements. FAC ¶ 1. DED occurs when the eye does not produce enough tears or when tears are not of the correct consistency. Id. ¶ 34. The disease is evidenced by inflammation and damage to the ocular surface, resulting in blurry or fluctuating vision and eye fatigue. Id. About one million Americans currently receive prescription drug treatment for DED. Id. ¶ 36.
The Parties and Their Products
Shire and Allergan are competitors in the pharmaceutical industry. Id. Shire is a *541New Jersey pharmaceutical company that develops, manufactures, markets, and distributes pharmaceutical products worldwide. Id. ¶ 26. Allergan is a Delaware pharmaceutical company that engages in research, development, manufacturing, sales, distribution, and marketing of specialty pharmaceutical products. Id. ¶ 30.
Both companies offer a prescription drug for the treatment of DED. Shire offers Xiidra® and Allergan offers Restasis ®. Id. ¶ 1. Xiidra and Restasis are the only FDA-approved prescription drugs on the market for treatment of DED. Id. ¶ 38. There are no reasonably available substitutes to treat DED. Id. ¶ 116. Over-the-counter treatments, such as artificial tears, are insufficient to treat the underlying inflammation that causes DED. Id.
The FDA approvals for Xiidra and Restasis are different in scope. Id. In July of 2016, the FDA approved Shire's Xiidra for treatment of both the symptoms and signs of DED. Id. ¶ 8. Clinical studies show that patients taking Xiidra experienced relief from DED symptoms of within as little as two weeks, and from underlying inflammatory conditions within six to twelve weeks. Id. ¶ 8. In contrast, the FDA has approved Restasis ® only for treatment of a specific symptom of DED - reduced tear fluid volume - which affects only ten percent of those with DED. Id. ¶ 38. Restasis has been on the market for fifteen years, during which time patients have reported ocular burning from using the drug. Id. ¶¶ 1, 40. One study indicated that 23% of patients discontinued use of Restasis within three months of first using it and 43% of patients stopped use within six months. Id. ¶ 40. Clinical studies reflect that it typically takes longer than six months for Restasis to become effective. Id. ¶ 40.
Given Xiidra's potential advantages over Restasis, it has been referred to by industry officials as a "big game changer." Id. ¶ 47. In the two years following its launch in 2016, Xiidra captured approximately 35% of the commercial DED market, and around 10% of the Part D DED market. Id. ¶ 122. Restasis maintains approximately 90% of the Part D DED market. Id. ¶ 131.
The Part D DED Market
For purposes of its antitrust claims, Plaintiff identifies the Part D DED market as the relevant product market. Id. ¶ 115. Congress passed Medicare to provide affordable medical assistance to the elderly, and enacted Part D specifically as an optional outpatient prescription drug program for senior citizens to receive discounted and subsidized prescription drugs. Id. ¶¶ 50-53. Because DED is a condition that progresses with age, it disproportionally affects the elderly. Id. ¶ 37. Prescriptions for DED treatment under Part D account for approximately 40% of all DED prescriptions.
Participants in Part D can choose from a variety of plans. Id. ¶ 53. The list of drugs covered by a particular plan is called the plan's "formulary." Id. ¶ 54. Formularies offer drugs in a number of tiers that dictate the patient's copayment. Id. ¶ 61. Drugs with the lowest copayment are listed in the "preferred" tier, followed by the "non-preferred" tier. Id. ¶ 61. If a drug is not listed on a formulary, then it is considered "not covered" and the patient must either pay for the drug in full (at a price that is typically two to five times higher than that listed on the formulary) or have his or her physician file a successful appeal with the plan seeking an exception.3 Id.
*542Hence, drugs not covered on formularies are faced with a competitive disadvantage in the Part D marketplace. Id. ¶ 64.
Plaintiff alleges that commercial prescription drug plans are not substitutes for Part D because individuals covered by Part D (individuals aged 65 and older or with permanent disabilities) receive lower premiums for a comprehensive list of prescription drugs. Thus, Part D participants have no need for traditional, commercial prescription drug plans. Id. ¶ 117. In fact, Plaintiff alleges that it, Defendants, and other industry participants recognize Part D as its own independent market, often using different staff or hiring third parties to engage with Part D administrators. Id. ¶ 118. Plaintiff adds that the Part D administrators also treat the Part D DED market differently than any separate commercial business that they may engage in. Id. ¶ 120.
The Alleged Anticompetitive Conduct
Plaintiff essentially alleges two forms of anticompetitive conduct by Defendants: anticompetitive bundling and exclusive dealing contracts. Id. ¶¶ 126-27. First, Plaintiff alleges that Defendants engaged in anticompetitive bundling by contracting with "Plan 1" and "Plan 2" to offer Restasis in a bundled portfolio of drugs at a price below its average variable cost. Id. ¶¶ 86, 91, 97. Second, Plaintiff alleges that Defendants engaged in an exclusive dealing contract with "Plan 3" whereby the plan is contractually barred from offering any other DED drug on its formulary for the foreseeable future. Id. ¶ 107.
A review of the seller-side of the Part D market is required to properly understand these claims. "Pharmaceutical companies negotiate annually with Part D plans to gain placement of their drugs on the plans' formularies for the coming year." Id. ¶ 68.
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John Michael Vazquez, U.S.D.J.
This matter concerns antitrust allegations in the Medicare Part D ("Part D") prescription drug market. D.E. 64. Plaintiff, Shire US, Inc. ("Shire"), alleges that Defendants are engaged in an "ongoing, overarching, and interconnected scheme" to systematically block Plaintiff from competing with Defendants in the Part D prescription drug market for treatment of dry eye disease in violation of Sections 1 and 2 of the Sherman Act and state law. D.E. 64 ¶¶ 1, 25. Defendants consist of Allergan, Inc.; Allergan Sales, LLC; and Allergan USA, Inc. (collectively "Defendants" or "Allergan"). The present matter comes before the Court on Defendants' motion to dismiss Plaintiff's First Amended Complaint ("FAC") for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6). D.E. 14. The Court reviewed all submissions1 and held oral argument on February 26, 2019. For the reasons that follow, Defendants' motion to dismiss is granted.
I. BACKGROUND2
Plaintiff Shire alleges that Allergan is coercing Part D prescription drug plans to effectively exclude Shire's superior dry eye disease ("DED") treatment drug from the market through a combination of anticompetitive bundling and exclusive dealing arrangements. FAC ¶ 1. DED occurs when the eye does not produce enough tears or when tears are not of the correct consistency. Id. ¶ 34. The disease is evidenced by inflammation and damage to the ocular surface, resulting in blurry or fluctuating vision and eye fatigue. Id. About one million Americans currently receive prescription drug treatment for DED. Id. ¶ 36.
The Parties and Their Products
Shire and Allergan are competitors in the pharmaceutical industry. Id. Shire is a *541New Jersey pharmaceutical company that develops, manufactures, markets, and distributes pharmaceutical products worldwide. Id. ¶ 26. Allergan is a Delaware pharmaceutical company that engages in research, development, manufacturing, sales, distribution, and marketing of specialty pharmaceutical products. Id. ¶ 30.
Both companies offer a prescription drug for the treatment of DED. Shire offers Xiidra® and Allergan offers Restasis ®. Id. ¶ 1. Xiidra and Restasis are the only FDA-approved prescription drugs on the market for treatment of DED. Id. ¶ 38. There are no reasonably available substitutes to treat DED. Id. ¶ 116. Over-the-counter treatments, such as artificial tears, are insufficient to treat the underlying inflammation that causes DED. Id.
The FDA approvals for Xiidra and Restasis are different in scope. Id. In July of 2016, the FDA approved Shire's Xiidra for treatment of both the symptoms and signs of DED. Id. ¶ 8. Clinical studies show that patients taking Xiidra experienced relief from DED symptoms of within as little as two weeks, and from underlying inflammatory conditions within six to twelve weeks. Id. ¶ 8. In contrast, the FDA has approved Restasis ® only for treatment of a specific symptom of DED - reduced tear fluid volume - which affects only ten percent of those with DED. Id. ¶ 38. Restasis has been on the market for fifteen years, during which time patients have reported ocular burning from using the drug. Id. ¶¶ 1, 40. One study indicated that 23% of patients discontinued use of Restasis within three months of first using it and 43% of patients stopped use within six months. Id. ¶ 40. Clinical studies reflect that it typically takes longer than six months for Restasis to become effective. Id. ¶ 40.
Given Xiidra's potential advantages over Restasis, it has been referred to by industry officials as a "big game changer." Id. ¶ 47. In the two years following its launch in 2016, Xiidra captured approximately 35% of the commercial DED market, and around 10% of the Part D DED market. Id. ¶ 122. Restasis maintains approximately 90% of the Part D DED market. Id. ¶ 131.
The Part D DED Market
For purposes of its antitrust claims, Plaintiff identifies the Part D DED market as the relevant product market. Id. ¶ 115. Congress passed Medicare to provide affordable medical assistance to the elderly, and enacted Part D specifically as an optional outpatient prescription drug program for senior citizens to receive discounted and subsidized prescription drugs. Id. ¶¶ 50-53. Because DED is a condition that progresses with age, it disproportionally affects the elderly. Id. ¶ 37. Prescriptions for DED treatment under Part D account for approximately 40% of all DED prescriptions.
Participants in Part D can choose from a variety of plans. Id. ¶ 53. The list of drugs covered by a particular plan is called the plan's "formulary." Id. ¶ 54. Formularies offer drugs in a number of tiers that dictate the patient's copayment. Id. ¶ 61. Drugs with the lowest copayment are listed in the "preferred" tier, followed by the "non-preferred" tier. Id. ¶ 61. If a drug is not listed on a formulary, then it is considered "not covered" and the patient must either pay for the drug in full (at a price that is typically two to five times higher than that listed on the formulary) or have his or her physician file a successful appeal with the plan seeking an exception.3 Id.
*542Hence, drugs not covered on formularies are faced with a competitive disadvantage in the Part D marketplace. Id. ¶ 64.
Plaintiff alleges that commercial prescription drug plans are not substitutes for Part D because individuals covered by Part D (individuals aged 65 and older or with permanent disabilities) receive lower premiums for a comprehensive list of prescription drugs. Thus, Part D participants have no need for traditional, commercial prescription drug plans. Id. ¶ 117. In fact, Plaintiff alleges that it, Defendants, and other industry participants recognize Part D as its own independent market, often using different staff or hiring third parties to engage with Part D administrators. Id. ¶ 118. Plaintiff adds that the Part D administrators also treat the Part D DED market differently than any separate commercial business that they may engage in. Id. ¶ 120.
The Alleged Anticompetitive Conduct
Plaintiff essentially alleges two forms of anticompetitive conduct by Defendants: anticompetitive bundling and exclusive dealing contracts. Id. ¶¶ 126-27. First, Plaintiff alleges that Defendants engaged in anticompetitive bundling by contracting with "Plan 1" and "Plan 2" to offer Restasis in a bundled portfolio of drugs at a price below its average variable cost. Id. ¶¶ 86, 91, 97. Second, Plaintiff alleges that Defendants engaged in an exclusive dealing contract with "Plan 3" whereby the plan is contractually barred from offering any other DED drug on its formulary for the foreseeable future. Id. ¶ 107.
A review of the seller-side of the Part D market is required to properly understand these claims. "Pharmaceutical companies negotiate annually with Part D plans to gain placement of their drugs on the plans' formularies for the coming year." Id. ¶ 68. The negotiations usually begin around April of "the preceding plan year and culminate in August of the same year when the plans finalize their formularies for the coming year." Id. Certain Part D plans delegate their negotiation and selection process to administrators. Id. ¶ 72. For example, "several of the top ten Part D plans and many smaller ones use another top ten plan (Plan 3) to negotiate and administer their formulary coverage." Id. As a result, Plan 3 negotiates with pharmaceutical companies on behalf of numerous Part D plans. Id. Similarly, "[p]harmaceutical companies typically contract with third party agents to oversee negotiations with plans for placement of their drugs on the plans' formularies," often to "keep[ ] [their] dealings with Part D plans separate from [their] dealings for commercial business."Id. ¶ 71.
During these annual negotiations, a pharmaceutical company seeks to secure its drugs' preferential placement on the Part D plan's formulary by minimizing the Part D plan's costs in offering the drugs. Id. ¶ 69. Although pharmaceutical companies do not sell their drugs directly to Part D plans, Part D plans reimburse pharmacies for dispensing covered drugs to participants. Id. ¶ 60. Therefore, to lower the plan's reimbursement expenses, pharmaceutical companies offer rebates and discounts to patients who acquire a prescription drug through a particular Part D plan. Id. ¶¶ 69-70. Pharmaceutical companies also offer price protection, meaning that if the price for their drug increases during the contractual term, rebates will also proportionally increase, ensuring that the plans do not incur any additional costs. Id. ¶ 70.
The top three plans in Part D are Plan *5431, Plan 2, and Plan 3.4 About 70% of the Part D prescriptions for DED treatment are derived from the three plans. Id. ¶ 109. Despite Plaintiff's view that Xiidra is superior to Restasis, Plaintiff has been unable to secure a "preferred" position for Xiidra on any of the formularies of these plans. Id. ¶¶ 87-109. Plaintiff alleges that this is because Defendants have unlawfully engaged in (1) anticompetitive bundling with Plan 1 and Plan 2, and (2) improper exclusionary contracting with Plan 3.5 Id. ¶¶ 86, 91, 97, 107.
Shire alleges that Allergan's technique of "bundling" rebates across its products, including Restasis, to secure exclusivity on top plans' formularies constitutes unlawful anticompetitive conduct. Id. ¶ 148. Allergan offers a number of products in its Part D portfolio aside from Restatsis. Id. ¶ 74. Among these other products are Lumigan ®, Combigan®, and Alphagan P ®. Id. The FDA approved Lumigan, Combigan, and Alphagan P for treatment of high eye pressure in patients with glaucoma or ocular tension. Id. ¶¶ 75-77. The FDA has not approved a generic substitute for any of these three drugs in the United States. Id. For the four quarters spanning from the third quarter of 2016 to the second quarter of 2017, the three glaucoma drugs accounted for almost $ 750,000,000 of Allergan's sales in Part D plans. Id. ¶ 78. Restasis accounted for $ 719,000,000 of Allergan's sales in Part D plans during this same period. Id. Thus, Plaintiff alleges that Allergan has "more than enough financial wherewithal" to offer Restasis to Part D plans "at an effective price that is below Allergan's average variable cost" and potentially even "for free" given the commercially advantageous positioning of Allergan's other offerings. Id.
Regarding Plan 1, which is responsible for nearly 25% of the Part D DED market, Plaintiff offered "substantial rebates and discounts" in attempts to have Xiidra placed on the plan's formulary. Id. ¶ 89. In response, Plan 1 informed Plaintiff that any placement of Xiidra on its formulary would result in the loss of rebates from Allergan, stating that "[y]ou could give [Xiidra] to us for free, and the numbers still wouldn't work." Id. ¶ 89. Further, Plan 1 told Plaintiff that it would need Allergan's "permission" for Xiidra to be listed on the formulary. Id. ¶ 90. Plan 1 eventually listed Xiidra on its formulary but only in its "non-preferred" tier, resulting in copayments that are two to five times higher than if Xiidra was listed in the "preferred tier" with Restasis. Id. Plaintiff believes that if the plan's formulary included Xiidra in any capacity other than "non-preferred," Plan 1 would "lose the price protection, rebates, and discounts on the entirety of Allergan's Part D portfolio." Id. ¶ 91. Plaintiff alleges that "[t]his makes it impossible for Shire to offer discounts on Xiidra that compete with the bundled rebates provided by Allergan and keep Xiidra's price above its cost." Id.
Regarding Plan 2, which is responsible for over 11% of the Part D DED market, Plaintiff also offered "substantial rebates and discounts" to list Xiidra on its formulary.
*544Id. ¶¶ 92-93. Plan 2 stated that listing Xiidra on its formulary would contractually cause Plan 2 to lose all of its "price protection" and "bundled rebates" from Allergan. Id. ¶ 93. Plan 2 added that it would need to first "check with Allergan and get its permission[.]" Id. ¶ 94. Nevertheless, the Centers for Medicare & Medicaid Services ("CMS"), who contract with Part D administrators, id. ¶ 53, later informed Plan 2 that it would have to offer Xiidra given its formulary classifications. Id. ¶ 94. Plan 2, however, only placed Xiidra on its formulary as "non-preferred" with prior authorization and "step through" requirements. This means that Plan 2 patients must first try Restasis and experience "failure" before Plan 2 will contribute towards their prescriptions for Xiidra. Id. ¶ 94. Additionally, the copay for Xiidra is still two to five times higher than if it was listed in the "preferred" tier. Id. ¶ 95. Plaintiff alleges that "[t]his makes it impossible for Shire to offer discounts on Xiidra that compete with the bundled rebates provided by Allergan and keep Xiidra's price above its cost." Id. ¶ 97.
Plaintiff alleges that Defendants had an exclusionary agreement with Plan 3. Id. ¶ 107. Plan 3 is responsible for 34% of the Part D DED market. Id. ¶ 98. Plaintiff alleges that it met the pricing requirements that Plan 3 had indicated would secure Xiidra's listing on Plan 3's formulary. Id. ¶ 100. Plan 3 confirmed that the offered pricing would "get it done" and that Plaintiff need not improve its offer. Id. ¶ 100. Plan 3 later retracted these statements, explaining that Xiidra could not be added to the formulary because it would create "too much disruption" as Allergan's contract with Plan 3 prohibited offering another DED treatment on the formulary. Id. ¶¶ 101-102. A "Shire executive" then asked Plan 3 how it could "get out" of this position in the future, to which Plan 3 responded, "you don't."6 Id. ¶ 102. Therefore, Xiidra is "not covered" by Plan 3's formulary, requiring Plan 3 patients to pay two to five times more for Xiidra than if Xiidra was listed as a "preferred" drug on the formulary like Restasis. Id. ¶ 104. Plaintiff alleges that Defendants' agreement with Plan 3 prohibits the plan from contracting with Defendants' competitors (such as Plaintiff) beyond the one-year term, regardless of the offer that the competitor may make. Id. ¶ 107.
Plaintiff also relies on a public statement by Allergan's CEO in mid-2017, stating that Allergan has "blocked" Plaintiff from the Part D DED market. Id. ¶ 14. Plaintiff continues that the financial terms (including discounts, rebates, and price protection) that Plaintiff offered the three Part D plans "far exceeded" the discount rates on Xiidra that Plaintiff successfully offered to commercial prescription drug plans. Id. ¶ 106. Thus, Plaintiff alleges that Allergan is engaged in an "overarching and interconnected scheme of anticompetitive tactics, which have successfully blocked Shire's access to the Part D market[.]" Id. ¶ 108.
Plaintiff alleges that Allergan's conduct will effectively deny or severely limit Part D beneficiaries' access to Xiidra, the only drug approved for the treatment of both the signs and symptoms of DED. Id. ¶ 136. Plaintiff asserts that Defendants' conduct forces Part D patients (i) to make higher copayments for Xiidra; (ii) to accept less value for their copayment because Restasis is inferior to Xiidra; and (iii) to incur higher costs for DED treatment by purchasing a topical steroid used in conjunction with Restasis treatment, which is unnecessary when using Xiidra. Id. ¶ 137. Plaintiff continues *545that it "will continue to lose millions of dollars in sales and profits from within the [Part D DED market]" as a result of Defendants' actions. Id. ¶ 151.
II. PROCEDURAL HISTORY
Plaintiff filed its Complaint on October 2, 2017, alleging seven causes of action: (I) monopolization under the Sherman Act,
On September 28, 2018, Plaintiff sought leave to amend its Complaint for the sole purpose of including money damages in the relief sought. D.E. 55. Because the proposed amendment did not alter any of the substantive allegations set forth in the original Complaint, the parties agreed that Defendants' pending motion to dismiss would apply to the FAC. See D.E. 58. On February 26, 2019, the Court held oral argument on the motion. D.E. 70.
III. STANDARD OF REVIEW
Rule 12(b)(6) of the Federal Rules of Civil Procedure permits a defendant to move to dismiss a count for "failure to state a claim upon which relief can be granted[.]" To withstand a motion to dismiss under Rule 12(b)(6), a plaintiff must allege "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly ,
In evaluating the sufficiency of a complaint, a district court must accept all factual allegations in the complaint as true and draw all reasonable inferences in favor of the plaintiff. Phillips v. Cty. of Allegheny ,
IV. ANALYSIS
Defendants argue that Plaintiff fails to plausibly plead a relevant product market and fails to sufficiently allege anticompetitive *546conduct. Def. Br. at 2-5, 13-39. Because the antitrust claims fail, Defendants continue, so must the tortious interference claim. Id. at 39-40. Plaintiff responds that it has plausibly alleged the relevant market and anticompetitive conduct. Pl. Opp'n at 14-38. It adds that tortious interference can exist separate and apart from the alleged anticompetitive conduct. Id. at 38-40.
Section 1 of the Sherman Act provides that "[e]very contract, combination in the form of trust or otherwise, or conspiracy, in restraint of trade or commerce among the several States, or with foreign nations, is declared to be illegal."
Section 2 of the Sherman Act prohibits "monopoliz[ing], or attempt[ing] to monopolize, or combin[ing] or conspir[ing] with any other person or persons, to monopolize any part of the trade or commerce among the several States, or with foreign nations."
Further, "the New Jersey Antitrust Act shall be construed in harmony with ruling judicial interpretations of comparable federal antitrust statutes." Eisai, Inc. v. Sanofi Aventis U.S., LLC ,
Relevant Product Market
In an antitrust matter, two markets must be defined: the relevant product market and the relevant geographic market. See LePage's Inc. v. 3M ,
*547Plaintiff responds that the injury is both to Shire and Part D DED patients, therefore the relevant product market should also take into account the consumer's perspective. Pl. Opp'n at 14-15. Plaintiff also notes that from the supplier's perspective, suppliers treat the Part D market independently from the commercial market, and practical indicia also demonstrate that the Part D market is distinct from the commercial market. Id. at 15-20.
The Third Circuit has not yet ruled on this issue, that is, the appropriate relevant product market when a supplier alleges that it has been improperly excluded. Although the matter is not free from doubt, the Court finds that under the circumstances alleged (that is, a supplier allegedly excluded from a market), the relevant product market consists of those to whom the supplier can sell unless special circumstances exist. As a result, Plaintiff's proposed relevant market - Medicare Part D - is not plausibly pled because it is too narrow. The proposed market fails to account for others, such as non-government payers, to whom Plaintiff can sell its product.
Before turning to the analysis of the relevant product market, the Court notes the overarching aim of antitrust law that permeates all aspects of the legal analysis: "[t]he purpose of the Sherman Act 'is not to protect businesses from the working of the market; it is to protect the public from the failure of the market.' " Brokerage Concepts, Inc. v. U.S. Healthcare, Inc. ,
Plaintiff points to Brown Shoe Co. v. United States ,
In United States v. Aetna Inc. ,
As noted, the Third Circuit has not expressly addressed the issue before the Court. Yet, in Brokerage Concepts, Inc. v. U.S. Healthcare, Inc. ,
In 1991, all of Gary's stores were approved providers in the defendant's HMO pharmacy network.
To evaluate plaintiff's Section 1 claim, Chief Judge Becker explained that the court first had to define the relevant product and geographic markets.
The plaintiff argued that the relevant product market was a "single brand market[,]" meaning only members of the defendant's HMO with prescription drug benefits.
Although the Third Circuit has not ruled on the pending issue, the Eighth Circuit has. In Little Rock Cardiology Clinic PA v. Baptist Health ,
The plaintiff defined the relevant product market as patients covered by private insurance, thereby excluding uninsured patients and patients covered by government insurance programs.
[The plaintiff] argues that the product market should be limited to patients using private insurance because private insurance and government insurance-the other primary method of payment-are not reasonably interchangeable. The trouble with this theory is that it analyzes the issue from the wrong side of the transaction. It may be true that, from the patient's perspective, private insurance and Medicare/Medicaid are not reasonably interchangeable . For a variety of reasons, including age and financial considerations, a person with private insurance may not qualify for these government programs. But this lawsuit is not about the options available to patients, it is about the options available to shut-out cardiologists .
The First Circuit has reached the same conclusion. See Stop & Shop Supermarket Co. v. Blue Cross & Blue Shield of R.I. ,
Certain courts have recognized that suppliers may nevertheless establish a special subgroup of buyers if the supplier shows that special circumstances exist. See, e.g. , Stop & Shop ,
The Methodist Health court, at the motion to dismiss stage, permitted the complaint to go forward although the plaintiff defined the relevant product market only as commercial payers, excluding government payers. Id. at *7. The district judge found that the plaintiff had adequately pled special circumstances; that is, the plaintiff alleged (and the defendant admitted) "that access to privately-insured patients is critical to a healthcare provider's long-term sustainability in light of the comparatively low prices providers are required to charge patients covered by government plans for the same services-prices that, in certain cases, may be below cost." Id. (internal citations omitted). Later, at the summary judgment stage, the Methodist Health court found for the defendant. Methodist Health Servs. Corp. v. OSF Healthcare Sys. , No. 13-1054,
Turning to the matter at hand, the Court finds that when a supplier who is allegedly shut out of a market (or a substantial portion of the market), the relevant product market consists of all persons or entities to whom that supplier can reasonably sell unless special circumstances exist. As a result, Plaintiff's product market of Medicare Part D is unduly narrow because it excludes others, notably commercial payers, to whom Plaintiff can sell Xiidra. Plaintiff also has not plausibly alleged special circumstances here. The Court therefore grants Defendants' motion to dismiss on this ground. This ruling follows the Eighth Circuit's decision in Little Rock and the First Circuit's ruling in Stop & Shop . However, the ruling also finds *552support in the Third Circuit's Brokerage Concepts decision. There, the Circuit did not limit the relevant market to potential pharmacy customers from the defendant's HMO as the plaintiff had advocated. The Third Circuit found that the defendant's HMO members who purchase prescription drugs were interchangeable with members of other prescription plans and uninsured persons because the proper perspective was that of Gary's, the pharmacy chain in question.
In other words, perspective is critical. In this case, the proper perspective is from the supplier's vantage point rather than the customer's view. For example, citing Brown Shoe and Aetna , Plaintiff places great emphasis on the fact it "separate[s]" its sales between commercial payers and government payers, e.g. , FAC ¶ 118, and it does plausibly plead this fact. In addition, the Court would be very surprised if Defendants did not do same. Putting aside price differentials, commercial and government health insurance entails different regulatory schemes. Id. ¶¶ 119-120. However, and critically, both Brown Shoe and Aetna dealt with potential mergers that were going to harm competition vis-a-vis consumers - not suppliers.12 The same has not been alleged here, and the Court finds that Plaintiff's relevant product market is not plausibly pled.
Anticompetitive Conduct
As noted, Plaintiff alleges two forms of anticompetitive conduct: Defendants' bundling agreements with Plans 1 and 2, as well as an exclusive dealing agreement with Plan 3. FAC ¶¶ 91, 97, 107. Defendants claim that their conduct is "nothing more than lawful competition on the merits," because (1) Defendants do not have monopoly power over their bundled glaucoma drugs; (2) Defendants' agreements with the plans are only for one-year; and (3) Defendants' combined pricing is not below the collective costs of the relevant drugs. Def. Br. at 25-39. Plaintiff responds that (1) Defendants have monopoly power over Restasis in the Part D market and do not need to have monopoly power over any of the non-competing glaucoma drugs; (2) Plaintiff lacks comparable glaucoma drugs to compete with Defendants' Part D bundle; and (3) Defendants' one-year contracts can still be anticompetitive. Pl. Opp'n at 24-35.
The Third Circuit has reviewed numerous cases involving bundling agreements and exclusive dealing arrangements. E.g. , Eisai Inc. v. Sanofi Aventis U.S. LLC ,
The plaintiff sued the defendant for a violation of Section 2 of the Sherman Act.
In LePage's , the defendant manufactured Scotch tape and controlled over 90% of the transparent tape market.
In evaluating the plaintiff's antitrust claims, the Third Circuit in LePage's discussed its earlier opinion in SmithKline , where it recognized that the gravamen of the defendant's Section 2 violation was that the defendant "linked a product on which it faced competition with products on which it faced no competition ."
More recently, in ZF Meritor , the relevant market was heavy duty ("HD") truck transmissions in North America.
The defendant was a monopolist in the market for HD transmissions in North America since the 1950s.
After the defendant entered into the LTAs with the OEMs, the defendant imposed additional price penalties on customers who selected the plaintiff's product and urged OEMs to "force feed" the defendant's product to customers.
The ZF Meritor court defined an exclusive dealing contract as an "an agreement in which a buyer agrees to purchase certain goods or services only from a particular seller for a certain period of time."
The ZF Meritor court ruled that "[d]ue to the potentially procompetitive benefits of exclusive dealing agreements, their legality is judged under the rule of reason [test]."
In applying the facts to this framework, the ZF Meritor court first explained that the plaintiff established exclusive dealing. Id. at 282-84. Although the LTAs did not expressly require exclusive dealing, the Circuit recognized that the LTAs' market penetration targets served, in effect, as mandatory purchase requirements. Id. at 282. The Third Circuit likened these agreements to the bundled rebates in LePage's , where no express exclusivity requirement existed, but the agreements were designed to, and did, operate as exclusive dealing agreements nonetheless. Id. (citing LePage's ,
The ZF Meritor court then turned to market conditions, recognizing that "[e]xclusive dealing will generally only be unlawful where the market is highly concentrated, the defendant possesses significant market power, and there is some element of coercion present."
The court in ZF Meritor then examined the extent of market foreclosure, the length of the LTAs, and anticompetitive provisions in the agreements. Id. at 286-87. The Circuit recognized that the defendant foreclosed a significant portion of the market, as the defendant entered into a LTA with each of the four OEMs and essentially required them to purchase 80% to 97.5% of their requirements from the defendant. Id. at 286. The impact, the court noted, was that the plaintiff's overall market share dropped, from 8-14% in 2003, to 4% in 2005. Id. The ZF Meritor court also observed that the LTAs were not short-term agreements. Id. at 287. The Circuit noted that courts have found agreements for under a year to be presumptively lawful and agreements for one to two years to be lawful under certain circumstances. Id. at 286-87. Although long-term exclusive dealing contracts are not per se unlawful, the ZF Meritor court found that the defendant's five-year exclusive dealing contracts with all four OEMs to secure over 85% of the market were "unprecedented." Id. Finally, the Circuit recognized that "the LTAs were replete with provisions that a reasonable jury could find anticompetitive," recognizing that defendant's provisions barring certain competitors' products from being listed in the OEMs' data books as a "disaster" for the competitors. Id. at 287. The ZF Meritor court concluded that "there was more than sufficient evidence for a jury to conclude that the cumulative effect of [the defendant]'s conduct was to adversely affect competition." Id. at 289.
In Eisai , the defendant sold Lovenox, an injectable anticoagulant drug, since 1993. Eisai ,
The plaintiff sued the defendant for violations of Section 1 and Section 2 of the Sherman Act, Section 3 of the Clayton Act, and sections of the New Jersey Antitrust Act.
The Third Circuit reviewed its past decisions in LePage's and ZF Meritor .
This Court makes a few observations in light of the foregoing cases. At the outset, neither bundled rebates nor exclusive dealing contracts are inherently anticompetitive. In fact, both can be procompetitive and potential anticompetitive effects are subject to a fact-sensitive analysis. One example of anticompetitive conduct, as discussed in SmithKline , occurs when a defendant offers a bundled rebate in which it links the competitive product with a product over which the defendant has a monopoly. Here, Plaintiff has not alleged that Defendants have a monopoly over the glaucoma drugs14 which it bundles with Restasis, the product competing with Plaintiff's Xiidra. As a result, SmithKline does not support Plaintiff's position.
A second scenario was discussed in Lepage's , which offered a variation on SmithKline . In both cases, the defendant tied its bundled rebate to a product over which it had a monopoly. However, in LePage's , the defendant went further and linked its bundled rebate to several product lines. The plaintiff, however, did not have competing product lines with which it could link its private label transparent tape. Here, as noted, Plaintiff has not plausibly alleged that Defendants have a monopoly over their bundled glaucoma drugs. Moreover, Plaintiff - a large pharmaceutical company - has also not asserted that it did not have other available products that it could offer Plan 1 or Plan 2 as part of a bundled rebate. LePage's , therefore, also does not support Plaintiff's position.
Additionally, Plaintiff does not find relief pursuant to ZF Meritor . ZF Meritor dealt with a highly concentrated market, HD transmissions, that had significant barriers to entry. Plaintiff has not made similar allegations concerning the pharmaceutical drug market in which it operates. Moreover, because the market in ZF Meritor was so highly-concentrated and because the defendant had been dominant in the market for decades, the OEMs had to have access to the defendant's products. No similar allegation has been made here as to Restasis ; that is, Plaintiff has not asserted that either government or commercial payers must have Restasis (or other Defendant products).
*558More importantly, ZF Meritor involved contracts that were at least five years in length. The contracts at issue here are for one year and are open to competitive bidding on an annual basis. FAC ¶ 68. As the Third Circuit observed in ZF Meritor , short-term agreements present little threat to competition. ZF Meritor ,
In sum, Plaintiff has not plausibly pled the requisite anticompetitive conduct. For this independent reason, the motion to dismiss is granted.
Tortious Interference
Defendants argue that because Plaintiff's tortious interference count is premised on the alleged anticompetitive conduct, and because the Plaintiff's anticompetitive conduct is not plausibly pled, the tortious interference count must also be dismissed. Def. Br. at 40. Plaintiff replies that tortious interference can encompass conduct broader than anticompetitive behavior; thus, its claim may stand even if the Court grants Defendants' motion to dismiss as to the antitrust allegations. Pl. Opp'n at 39-40.
Under New Jersey law, tortious interference has four elements: "(1) a reasonable expectation of economic advantage to plaintiff, (2) interference done intentionally and with 'malice,' (3) causal connection between the interference and the loss of prospective gain, and (4) actual damages." Varrallo v. Hammond Inc. ,
V. CONCLUSION
In sum, the Court grants Defendants' motion to dismiss Plaintiff's First Amended Complaint, D.E. 14. The Court dismisses all counts without prejudice. Plaintiff has thirty (30) days to file a second amended complaint, if it so chooses, consistent with this Opinion. If Plaintiff fails to file a second amended complaint, the dismissal of Plaintiff's counts will be with prejudice. An appropriate Order accompanies this Opinion.
Related
Cite This Page — Counsel Stack
375 F. Supp. 3d 538, Counsel Stack Legal Research, https://law.counselstack.com/opinion/shire-us-inc-v-allergan-inc-njd-2019.