In re Epipen (336 F. Supp. 3d 1256, 2018)

Daniel D. Crabtree, United States District Judge

This Order addresses the pending Motions to Dismiss in one of the two separate tracks of this MDL-the consumer class cases track. The consumer class track consists of cases filed by individual consumers or third-party payors who allege they purchased EpiPens for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries. After the Judicial Panel on Multidistrict Litigation transferred five consumer class cases and one other filed by Sanofi-Aventis U.S. LLC ("Sanofi") to our court for coordinated and consolidated proceedings (Docs. 1, 5, & 9), the consumer class plaintiffs filed a Consolidated Class Action Complaint ("Class Complaint") (Doc. 60). The Class Complaint asserts federal and state antitrust claims, federal RICO Act violations, various state consumer protection law violations, and unjust enrichment claims. The Class Complaint also seeks class action certification.

The Class Complaint asserts its claims against two groups of defendants who are either sellers or manufacturers of the EpiPen. One group consists of defendants Mylan N.V., Mylan Specialty L.P., Mylan Pharmaceuticals, Inc., and Mylan's CEO Heather Bresch (collectively "the Mylan Defendants"). The other group of defendants consists of Pfizer, Inc., King Pharmaceuticals, Inc., and Meridian Medical Technologies, Inc. (collectively "the Pfizer Defendants"). When referring to both sets of defendants, this Order simply calls them, collectively, "defendants."

Defendants have filed separate motions asking the court to dismiss the Class Complaint. Doc. 92 (Pfizer Defendants' Motion to Dismiss Plaintiffs' Consolidated Class Action Complaint); Doc. 94 (Mylan Defendants' Motion to Dismiss Plaintiffs' Consolidated Class Action Complaint). The class plaintiffs have submitted an Omnibus Response to the Motions to Dismiss. Doc. 123. And both sets of defendants have filed Replies. Doc. 216 (Pfizer Defendants' Reply); Doc. 219 (Mylan Defendants' Reply). Also, on March 14, 2018, the Mylan Defendants submitted a Notice of Supplemental Authority under D. Kan. Rule 7.1(f). Doc. 394. The class plaintiffs filed a response, objecting to the supplemental submission. Doc. 403. Then, on July 6, 2018, the class plaintiffs filed a Notice of Supplemental Authority (Doc. 765), and the Mylan Defendants submitted a response to their submission (Doc. 785). On July 11, 2018, the class plaintiffs filed another Notice of Supplemental Authority (Doc. 781), and the Mylan Defendants filed a response to that submission as well (Doc. 803). Finally, on August 12, 2018, the class plaintiffs filed another Notice of Supplemental Authority (Doc. 874), and the Mylan Defendants filed a response to that submission (Doc. 889).

Thus, to say the least, the Motions to Dismiss are now thoroughly and fully briefed. After carefully considering the arguments presented by the parties' filings, the court is prepared to rule. For the reasons explained below, the court grants defendants' motions in part and denies them in part.

I. Factual Background

The following facts come from the Class Complaint. The court accepts the facts asserted in the Class Complaint as true and views them in the light most favorable to the class plaintiffs. Mayfield v. Bethards , 826 F.3d 1252, 1255 (10th Cir. 2016) (citation omitted).

The EpiPen is a disposable, prefilled automatic injection device that delivers epinephrine (also known as adrenaline) to treat severe allergic reactions known as anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that can occur rapidly after exposure to an allergen. Anaphylaxis manifests in a variety of symptoms, including swelling of the tongue and throat, vomiting, reduced blood pressure, difficulty breathing, and, if untreated, death. Most commonly, anaphylaxis is caused by food allergens, but medications, latex, insect bites, and other unknown substances also can cause anaphylaxis. About 15 million people have food allergies in the United States. One of every 13 children in the United States has serious food allergies. And, each year, allergic reactions account for some 200,000 emergency room visits. Anaphylaxis is always considered a life-threatening medical emergency.

Epinephrine is used to treat anaphylaxis and is available only by prescription. To treat anaphylaxis effectively, one must administer epinephrine immediately. As little as a thirty minute delay in applying epinephrine can cause death. As a result, patients prone to anaphylaxis are advised to carry an epinephrine auto-injector ("EAI") at all times. By doing so, a patient can use the EAI in an emergency when a risk of a severe allergic reaction presents itself.

In 2007, Mylan acquired the right to market and distribute the EpiPen. Pfizer is the exclusive supplier of EpiPens to Mylan. Pfizer provides Mylan with 100% of its EpiPen supply through two of its wholly owned subsidiaries-King Pharmaceuticals, Inc., and Meridian Medical Technologies, Inc.-who manufacture the epinephrine and hold the EpiPen patents. Since at least 2009, Mylan's market share of EAI devices in the United States EAI market has remained above 80%. Since 2009, Mylan's market share consistently has exceeded 90%, and, in 2012, its share was almost 100%. During the same time-and while the cost of the EpiPen's dose of epinephrine has remained about $1-Mylan has increased the EpiPen's price by more than 600%. In 2007, Mylan priced the EpiPen at $100. By 2016, Mylan was charging more than $600. In 2015, Mylan announced that the EpiPen had reached $1 billion in annual sales for the second consecutive year-up from $200 million in 2007.

The Class Complaint alleges that the Mylan and Pfizer Defendants have maintained a monopoly over the EpiPen market and its profitable revenues by devising an illegal scheme to monopolize the market for EAI devices. The Class Complaint asserts that defendants carried out their illegal scheme through several different avenues. The following paragraphs briefly summarize each one, as the Class Complaint describes them.

The Mylan Defendants Paid Pharmacy Benefit Managers (PBMs) to Exclude Competition

Pharmacy Benefit Managers ("PBMs") are third-party administrators of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans. More specifically, PBMs administer a health coverage provider's prescription benefit program by developing the coverage provider's formulary (the list of prescription benefits included in the coverage at various pricing "tiers"), processing claims, creating a network of retail pharmacies who provide discounts in exchange for access to a provider's plan participants, and negotiating with manufacturers. The significant majority of patients with prescription drug insurance coverage receive their benefits through a third-party payor whose drug formulary is determined by a PBM. From 2013 to 2015, commercial third-party payors accounted for about 71% of the EAI drug device market in the United States. So, for a competitor to enter and compete vigorously in the EAI drug device market, it is imperative that it access these third-party payors' drug formularies.

Between 2013 and 2015, the Mylan Defendants took advantage of their monopoly power by imposing significant increases in the EpiPen's price. Mylan then used the additional profit margins to offer PBMs significantly higher rebates and percentage discounts conditioned upon exclusive or preferred placement on the PBMs' drug formularies. For example, when Sanofi launched a rival EAI device-Auvi-Q-in 2013, Mylan began taking steps to block Auvi-Q from drug formularies. It did so by offering large rebates to the PBMs who controlled the formularies for third-party payors-30% or higher-and expressly conditioning those rebates on: (a) granting the EpiPen exclusive position on the formulary; and (b) removing (or severely restricting) access to Auvi-Q. Mylan also targeted another rival EAI device-Adrenaclick-with the exclusionary rebate program. Adrenaclick's market share has ranged from only 2% in 2013 to 8% in 2016. Mylan knew that Adrenaclick-as well as Auvi-Q-could not raise prices to inflate their margins sufficiently to offer rebates or discounts similar to those that Mylan was offering to PBMs. In 2014, CVS Caremark added Adrenaclick to its Formulary Drug Removals List, effectively removing a consumer or other end-payor's opportunity to purchase Adrenaclick as an alternative to the EpiPen.

The class plaintiffs allege that the Mylan Defendants' exclusionary rebate scheme deprives patients of a fair price for EAI devices-the price that would result from normal market forces. Instead of lowering its prices to gain market share, Mylan bargains for its market share by providing ever-larger rebates and other kickbacks to PBMs, conditioned on exclusive relationships with those PBMs. Mylan can position itself on the drug formularies by using its monopoly power to charge consumers higher prices for its product. It then can share these revenues with the PBMs (the ones who create the formularies) through substantially enhanced rebates conditioned on excluding insurance coverage for rival products. This conduct, in turn, inflates the prices that consumers pay for the EpiPens so that Mylan can preserve its net realized price and sales volumes. The class plaintiffs contend that the net effect of this scheme harms both consumers and competitors alike.

The Mylan Defendants Entered into an Exclusive School Access Scheme

The class plaintiffs next assert that the Mylan Defendants leveraged the EpiPen's dominant market position to foreclose competition in an EAI submarket-i.e. , American public schools. They did so by offering to supply a portion of each school's need for EAI devices on a free or discounted basis but conditioning those discounts on the school entering an exclusive dealing contract. The Mylan Defendants created this important submarket by increasing federal lobbying efforts to gain access to parents, educators, and medical professionals in public schools. As part of the lobbying effort, Mylan spent a reported $4 million specifically lobbying to pass the School Access to Emergency Epinephrine Act. The law was enacted in 2013. It gives federal funding priority to schools who stockpile EAIs. Mylan's lobbying efforts proved enormously successful. Now, a majority of states permit their public schools to stockpile EAIs while eleven states require EAI stockpiling. Given the EpiPen's dominant market position, the Act not only has provided EpiPen access to schools, but also it has mandated some schools to stockpile the product.

After securing the EAI stockpiling requirement, Mylan acted quickly to exclude competing EAIs from this valuable school submarket. As part of the Mylan Defendants' scheme, Mylan launched the "EpiPen4Schools" program. The program gives away free and discounted EpiPens to school districts-ones subject to the new law now requiring (or strongly encouraging) them to stockpile the devices. But Mylan conditioned the free and discounted EpiPens on the schools entering exclusive dealing agreements with Mylan. The purpose of these exclusive dealing agreements was to exclude competitors-like Auvi-Q and Adrenaclick-from the public school submarket. In the fall of 2016, the New York Attorney General and members of the United States Senate announced investigations into the anticompetitive terms of Mylan's EpiPen4Schools program. Later, Mylan eliminated the EpiPen4Schools program's exclusivity requirement.

Defendants, Working Together, Used the Judicial and Regulatory Processes to Protect their Monopoly

The Class Complaint next asserts that the Mylan and Pfizer Defendants worked "hand-in-hand," using patent litigation and the Food and Drug Administration ("FDA") regulatory process to erect barriers to market entry and delay EAI competition. Class Compl. ¶ 314. The Pfizer Defendants own the patents protecting the EpiPen and serve as the contract supplier of the product. The Mylan Defendants own the trademarked brand names and control the worldwide marketing and sale of the product. Together, defendants have a unified interest in protecting the EpiPen monopoly. So, the class plaintiffs allege, defendants collaborated to enhance the EpiPen's sales volume and profitability, fend off competitors, and protect the EpiPen patents by using the judicial and regulatory process to restrain competition.

Defendants did so by adding several more patents to the already-patented EpiPen to prevent the launch of competing generics. Defendants have four patents on the EpiPen. According to the class plaintiffs, none of them are designed to enhance the product. Instead, the patents' purposes are to stop generic competitors. Indeed, Mylan CEO Heather Bresch announced during a public earnings call in 2009 that Mylan was adding another patent to the already-patented EpiPen device that "will also put in another barrier to entry because ... now that market preferential would be the needle protected device and drug of which we have IP and stuff around. So I just think it is a very, very difficult hurdle to get through, and so feel confident that EpiPen is in good shape." Class Compl. ¶ 238. On September 14, 2010, Meridian secured U.S. Patent No. 7,794,432 -less than three weeks before Intelliject (the inventor of Auvi-Q) submitted its New Drug Application ("NDA") to the FDA.

Defendants also worked together to stop generic competition to the EpiPen by filing patent infringement lawsuits. They filed such lawsuits against three generic EpiPen rivals-Sandoz, Teva, and Intelliject-and then entered into anticompetitive settlements with impending generic manufacturers.

Teva Settlement

In December 2008, Teva filed an Abbreviated New Drug Application ("ANDA") seeking FDA approval to market a generic EpiPen. In August 2009, Pfizer's subsidiaries-King and Meridian-sued Teva for infringing U.S. Patent No. 7,449,012 ("the Teva Litigation"). In November 2010, King and Meridian filed a First Amended Complaint that included a claim for infringing the newly secured '432 patent. Later, King and Meridian dropped their claims based on infringing the '012 patent, leaving only the claims for infringing the '432 patent.

After discovery and a bench trial in March 2012, the parties settled the Teva Litigation on April 27, 2012. According to the class plaintiffs, defendants and Teva entered an unlawful settlement agreement that required Teva to delay launching its generic EAI for three years-until June 22, 2015-in exchange for defendants providing significant consideration, incentives, and benefits to Teva. The Class Complaint lists several facts about the Teva settlement that, the class plaintiffs contend, show defendants made a substantial "reverse payment" to Teva to convince it to delay bringing its competing product to market. These facts include:

• The court's Markman rulings interpreting the terms of the '432 patent were favorable to Teva.

• The parties settled the litigation after completing a full bench trial, meaning that the parties likely would incur marginal litigation expenses going forward, as compared to the expenses already incurred at settlement.

• No rational economic actor with a viable product (and who had spent millions of dollars developing it) would refrain from entering a lucrative market for 36 months unless it received monetary compensation in exchange for non-entry.

• In 2012, the Federal Trade Commission reported seeing "a record number of settlements involv[ing] potential pay-for-delay agreements," and that, in patent settlements involving a "first-filer" like Teva, the majority of the settlements involved explicit compensation in return for delayed entry (Class Compl. ¶¶ 267-68).

• On the same day of the Teva settlement, Mylan issued a joint press release announcing the settlement on its own behalf and for Pfizer.

• Four days after announcing the Teva settlement, Teva and Mylan settled another lawsuit where Teva had asserted patent infringement claims against Mylan based on Mylan's application to market a generic version of Teva's drug, Nuvigil. With the Nuvigil settlement, Mylan agreed to delay market entry until June 2016. Like the EpiPen, Nuvigil had annual sales hovering near $1 billion. So, procuring delayed entry of generics for both Nuvigil and the EpiPen was valuable to all parties involved.

• The Teva settlement has come under congressional scrutiny as a "pay-for-delay" agreement.

During the same time period, the Teva settlement also prevented competition from any other generic EAI device. Defendants knew that their agreement with Teva would delay market entry because Teva was subject to the Hatch-Waxman Act's 180-day exclusivity award. This provision grants a six-month exclusivity period to the first generic to challenge a brand firm's patent, claiming it is invalid or not infringed. The exclusivity period begins when the first-filing generic enters the market. Here, Teva was the first filer. So, with Teva delaying its market entry under the parties' settlement, Teva's exclusivity period could not begin running until at least three years in the future. As a result, defendants delayed all generics seeking ANDA applications based on the EpiPen.

In a public earnings call, Mylan's CEO Heather Bresch described how the Teva settlement had delayed market competition. Also, she appeared to concede that Mylan had participated in the Teva settlement. In July 2012, she stated publicly: "So we certainly have seen a benefit [to growing the EpiPen market] and obviously, now with the runway absolutely clear for us through 2015, through our settlement with Teva, I can assure you, we are going to continue as we see [the] response continue to invest in EpiPen as a franchise." Class Compl. ¶ 277 (emphasis added).

Intelliject Settlement

Defendants initiated another patent lawsuit against Intelliject-the inventor of Auvi-Q-when Intelliject sought FDA approval for its competing EAI. In 2009, Sanofi announced it had acquired the rights to Intelliject's EAI and that under its license, Sanofi would manufacture and commercialize the product while Intelliject would continue developing the product and work to secure regulatory approval. On January 11, 2011, defendants-through King-filed a patent infringement lawsuit against Intelliject seeking to block FDA approval of its NDA for its product-one that later became known as Auvi-Q. King's lawsuit alleged that Intelliject's EAI infringed the '432 patent -a patent that Meridian secured more than a year after Intelliject began developing its product and less than three weeks before Intelliject filed its NDA.

On August 1, 2011-less than eight months after King filed its lawsuit-the FDA announced that it was giving Intelliject's EAI tentative final approval, pending resolution of the patent litigation that King filed. Six months later, the parties announced that they had settled the Intelliject litigation. Again, Mylan announced the settlement jointly for itself and Pfizer. Although the parties did not make public the specific terms of the agreement, they announced that the agreement prevented Intelliject and Sanofi from launching their EAI product for another nine months-until November 15, 2012. Intelliject and Sanofi made the agreement not to enter the market until November 15, 2012, in exchange for valuable consideration. Through the Intelliject litigation, defendants effectively blocked competition from Intelliject's competing device for almost two years.

Sandoz Settlement

In 2010, another EAI competitor-Sandoz, Inc. ("Sandoz")-attempted to enter the EAI market by filing an ANDA for its own generic EpiPen alternative. Similar to the other lawsuits against Teva and Intelliject, defendants-through King-filed a patent infringement suit against Sandoz. According to the class plaintiffs, defendants' approach to Sandoz was to stall its ANDA by staying the action. The court administratively terminated the Sandoz litigation, giving the parties the ability to reopen the case by letter request. No party has reopened the case. So, to date, Sandoz's FDA approval and any definitive ruling on the EpiPen patents are stayed indefinitely. The class plaintiffs allege that defendants entered an agreement with Sandoz to stay the case in exchange for valuable consideration paid to Sandoz.

FDA Citizen Petition

The Class Complaint next alleges that, with Teva's generic EAI entry into the market looming, defendants took another step to block generic competition from the market by filing an FDA Citizen Petition. An FDA Citizen Petition provides the public with an avenue to present safety concerns to the FDA. But here, the class plaintiffs allege, defendants used the FDA Citizen Petition process to delay-further-Teva's entry into the market and to prevent Teva's product from competing with the EpiPen.

On January 16, 2015, Mylan filed a Citizen Petition "a mere six months before Teva was scheduled (pursuant to the settlement) to enter the market." Class Compl. ¶ 311. Antitrust scholar Michael Carrier of Rutgers Law School described Mylan's Petition in this fashion:

In its petition, Mylan contended that Teva should be required to demonstrate that its product was the "same as" Mylan's EpiPen. In other words, even though the parties had already agreed through settlement to delay Teva's generic entry for more than three years, Mylan sought to further delay the entry of Teva's generic through its citizen petition.

In addition to its January 2015 petition, the company waited almost five months after filing and only weeks before the FDA was required to respond, until May 2015, to supplement its petition with a 48-page independent study purportedly showing that patients would not use Teva's generic product correctly.

Given that Teva's generic product had been in development for at least six years before the petition's filing, this late-filing of a supplemental study implicates significant timing questions. Why would such a study be submitted only weeks before the FDA was required to respond under the FDA's 150-day clock?

Id. (quoting Michael A. Carrier & Daryl Wander, Citizen Petitions: An Empirical Study , 34 Cardozo L. Rev. 249, 279 (2012) ). According to the class plaintiffs, Mylan's submissions to the FDA rested on fundamentally flawed studies and the medical opinions of a doctor whom Mylan had paid some $95,000 in fees.

According to the class plaintiffs, without defendants' use of the FDA Citizen Petition process, Teva would have entered the market much sooner after addressing any FDA concerns and securing FDA approval. The class plaintiffs also assert that, from 2009 to present, defendants' actions deterred not only Teva, but also many more potential generics companies from developing and launching competing products.

Defendants Implement a Pricing Scheme

The Class Complaint next alleges that the Mylan Defendants implemented a pricing scheme that defrauded U.S. consumers into paying an inflated price for the EpiPen-one that climbed by more than 500%. The Mylan Defendants allegedly implemented this pricing scheme working alongside PBMs. Mylan is a generics company that typically makes low margins on drug sales. But the EpiPen-a specialty branded drug-represented a unique and highly profitable revenue stream for Mylan. Recognizing this opportunity, Mylan CEO Heather Bresch and other executives decided to exploit the EpiPen to generate billions of dollars in revenue for Mylan. According to the class plaintiffs, the Mylan Defendants and the PBMs distracted consumers and regulators from the reality that defendants were raising the price of the EpiPen from $100 to $600 by launching a campaign of false and misleading statements and actions.

One of the ways that the Mylan Defendants allegedly implemented their pricing scheme was changing the way Mylan sold the EpiPen. On August 24, 2011, Mylan announced that it no longer would sell individual EpiPens in the U.S. Instead, Mylan forced U.S. consumers to purchase EpiPens in pairs with the EpiPen 2-Pak. The class plaintiffs refer to this change as the "hard switch." And the class plaintiffs allege that the "hard switch" forced consumers and third-party payors to overpay for the EpiPen 2-Pak because the switch, in effect, doubled the EpiPen's price.

From 1987 to 2011, Mylan and others had sold the EpiPen one at a time in the U.S. without incident. Nothing changed in 2011 that required Mylan to sell the EpiPen as a 2-Pak. The EpiPen 2-Pak is just two individual EpiPens connected by a grey piece of plastic. The class plaintiffs allege that no medical reason exists to force customers to purchase a 2-Pak instead of a single EpiPen. Instead, Mylan deceptively suggested that the 2-Pak was medically required even though EpiPens are sold individually in every other country besides the United States. Also, Mylan's packaging offers no medical instructions or guidelines for patients to know whether, or when, to administer the second back-up EpiPen.

Beginning in 2011, Mylan began raising the price of the EpiPen while forcing customers to buy EpiPens in the 2-Pak. In October 2011, Mylan increased the price of an EpiPen 2-Pak to $181. And by May 2016, the price of an EpiPen 2-Pak jumped to $608.

The Mylan Defendants Have Made Various Misrepresentations and Omissions in an Effort to Conceal Their Anticompetitive Conduct

Finally, the Class Complaint alleges that the Mylan Defendants have spread false and misleading information and omitted material information as part of their scheme to monopolize the EAI market. They spread, the Class Complaint alleges, four broad categories of false and misleading information.

First , the class plaintiffs allege, Mylan created and spread misinformation about a competing EAI device-Auvi-Q. Although the FDA had determined that the epinephrine in Auvi-Q is a bioequivalent to the epinephrine in the EpiPen, Mylan funded and promoted a study entitled, "Auvi-Q versus EpiPen Auto-Injectors: Failure to Demonstrate Bioequivalence of Epinephrine Delivery Based on Partial Area Under the Curve." Class Compl. ¶ 229. Mylan intended the study to undermine the FDA's conclusion that Auvi-Q had demonstrated bioequivalence to the epinephrine in the EpiPen-in direct contradiction to the FDA's conclusion.

The class plaintiffs also allege that Mylan made false and misleading statements about Auvi-Q's formulary status. According to the class plaintiffs, Mylan's anticompetitive conduct caused major health plans either to limit their coverage of Auvi-Q or to exclude Auvi-Q from coverage altogether. Mylan did so by paying formularies to exclude Auvi-Q from coverage. But then, Mylan marketed to physicians the fact that Auvi-Q was not covered by formularies and suggested that the decision to exclude Auvi-Q from coverage was based on clinical recommendations-and not Mylan's large, conditional rebate offers.

Second , the class plaintiffs allege that Mylan made false and misleading statements about the "hard switch" to the EpiPen 2-Pak. On August 24, 2011, Mylan issued a news release entitled "Dey Pharma to Offer EpiPen 2-Pak and EpiPen Jr 2-Pak Exclusively." Class Compl. ¶ 336. The press release's subheadline provided: "Decision aligns with recent clinical guidelines for patients at risk for or who have experienced anaphylaxis to have immediate access to two doses of epinephrine." Id. The Class Complaint alleges that the press release was fraudulent and misleading for several reasons. They include:

• The press release cited a National Institute of Allergy and Infectious Diseases ("NIAID") study that did not apply to the general population. Instead, it applied only to a narrow subset: allergy sufferers who had already (1) been hospitalized for (2) a food allergy.

• Mylan purported to rely on the World Allergy Organization ("WAO") global standard in making the switch, but Mylan did not require sale of the EpiPen 2-Pak globally. Indeed, the press release states that the single EpiPen Auto-Injector package configuration will remain available outside of the U.S.

• The switch to the 2-Pak did not change patient access to two doses of epinephrine. Doctors could write, and often did write, prescriptions for two EpiPens. So, no need existed for Mylan to mandate something patients could purchase already.

• The medical guidelines recited did not state that providers must sell two doses of epinephrine. Instead, Mylan used the WAO's vague statement as a false pretext for selling only the 2-Pak.

• No mandates required Mylan to sell the EpiPen exclusively as a 2-Pak, or not at all.

• No medical studies support the decision to sell the EpiPen exclusively as a 2-Pak.

• From 1987 until 2011, the EpiPen was sold individually without incident. Nothing changed suddenly in 2011 that required Mylan to sell only the 2-Pak.

• When Mylan switched to the 2-Pak in 2011, it did not order a recall or insist that all U.S. EpiPen patients immediately go buy a second EpiPen.

• Although the press release relies on the WAO, the U.S. is the only country where Mylan required customers to purchase a 2-Pak of the EpiPen.

• According to a study conducted by the American Academy of Allergy, Asthma & Immunology, only a small number of patients require a second dose. The reason for selling the device solely in packs of two is to account for user error due to the imperfect product design, i.e. , 14% of parents accidently stick the needle in their own thumb instead of in their child's leg.

• Mylan offers no medical guidelines or instructions to EpiPen 2-Pak consumers in its packaging or on the device to explain how or when to use (or even how to store) the second EpiPen in the 2-Pak.

• Mylan states that between 1-20% of patients might need a second device. But, according to class plaintiffs, the margin of 1-20% is so wide that it is meaningless and provides a false justification for the "hard switch" to the 2-Pak.

Class Compl. ¶ 339. The class plaintiffs also allege that the NIAID panel Mylan relied on to justify the change to the 2-Pak was influenced and tainted by Mylan's financial contributions. The August 24, 2011, press release quotes Dr. Phillip Lieberman, a member of the NIAID panel, as stating that up to 20% of patients will require more than one dose of epinephrine to relieve symptoms. According to the class plaintiffs, Dr. Lieberman's statement does not explain why a 2-Pak is necessary for 100% of patients when only "up to 20%" require more than one dose. Also, his statement never explains why all patients must purchase two EpiPens instead of having a prescription that allows two doses. The class plaintiffs allege that Dr. Lieberman made his statement justifying the switch to the 2-Pak because Mylan paid him to do so.

Third , the class plaintiffs allege, Mylan made false statements about coupons, rebates, and generics. Mylan has stated publicly on its website and to the media throughout at least 2016 that 80% of consumers with insurance pay nothing for the EpiPen. According to the class plaintiffs, this statement is false because third-party payors end up paying the bulk of the cost for the EpiPen and, in turn, the third-party payors pass on the costs to patients with increased premiums. Mylan also announced recently that it will begin offering a $300 generic version of the EpiPen. The class plaintiffs assert that Mylan's admission that it can make a $300 generic using the same factories and components used to make the $600 EpiPen shows that Mylan is price gouging consumers with its current list price for the EpiPen.

Finally , the Class Complaint alleges that Mylan made false statements to Congress under oath to help cover up its fraud and to deceive the public about the EpiPen price increases. The Class Complaint asserts that CEO Heather Bresch falsely testified to Congress on September 21, 2016, when she: (1) misrepresented Mylan's profit on the EpiPen as $50 per device, but, according to a Wall Street Journal article, Mylan's profits were 60% higher than that amount; (2) misrepresented that Mylan had invested more than $1 billion in the EpiPen when, in fact, Mylan acquired the EpiPen in 2007 without incurring any research and development expenses; (3) misrepresented that Mylan had provided free EpiPens to more than 66,000 U.S. schools with "no strings attached," but Mylan, in fact, did attach strings to the free EpiPens by requiring the schools to sign a contract agreeing not to purchase any products from Mylan's competitors for a twelve-month period; (4) misrepresented that Mylan had reduced U.S. healthcare costs by about $180 billion; and (5) mispresented that 85% of EpiPen patients pay less than $100 for a 2-Pak and a majority pay less than $50.

II. Legal Standard

Fed. R. Civ. P. 8(a)(2) provides that a complaint must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Although this Rule "does not require 'detailed factual allegations,' " it demands more than "[a] pleading that offers 'labels and conclusions' or 'a formulaic recitation of the elements of a cause of action' " which, as the Supreme Court explained, "will not do." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ).

When considering a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), the court must assume that the factual allegations in the complaint are true. Id. (citing Twombly , 550 U.S. at 555, 127 S.Ct. 1955 ). But the court is " 'not bound to accept as true a legal conclusion couched as a factual allegation.' " Id. (quoting Twombly , 550 U.S. at 555, 127 S.Ct. 1955 ). " 'Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice' " to state a claim for relief. Bixler v. Foster , 596 F.3d 751, 756 (10th Cir. 2010) (quoting Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 ). Also, the complaint's "[f]actual allegations must be enough to raise a right to relief above the speculative level." Twombly , 550 U.S. at 555, 127 S.Ct. 1955 (citations omitted).

For a complaint to survive a motion to dismiss under Rule 12(b)(6), the pleading "must contain sufficient factual matter, accepted as true, to 'state a claim for relief that is plausible on its face.' " Iqbal , 556 U.S. at 679, 129 S.Ct. 1937 (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. at 678, 129 S.Ct. 1937 (citing Twombly , 550 U.S. at 556, 127 S.Ct. 1955 ). "The plausibility standard is not akin to a 'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully." Id. (quoting Twombly , 550 U.S. at 556, 127 S.Ct. 1955 ); see also Christy Sports, LLC v. Deer Valley Resort Co., Ltd. , 555 F.3d 1188, 1192 (10th Cir. 2009)

("The question is whether, if the allegations are true, it is plausible and not merely possible that the plaintiff is entitled to relief under the relevant law." (citation omitted) ).

In the antitrust context, the Supreme Court observed in Twombly that "proceeding to antitrust discovery can be expensive." Twombly , 550 U.S. at 558, 127 S.Ct. 1955 (applying the plausibility pleading standard to Sherman Act claims). So, courts must " 'insist upon some specificity in pleading before allowing a potentially massive factual controversy to proceed.' " Id. (quoting Associated Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters , 459 U.S. 519, 528 n.17, 103 S.Ct. 897, 74 L.Ed.2d 723 (1983) ). But still, antitrust cases are not subject to a standard requiring "heightened fact pleading of specifics." Id. at 570, 127 S.Ct. 1955. Instead, an antitrust Complaint must allege "only enough facts to state a claim to relief that is plausible on its face" sufficient to "nudge[ ] the[ ] claims across the line from conceivable to plausible." Id. ; see also In re Urethane Antitrust Litig. , 663 F.Supp.2d 1067, 1074 (D. Kan. 2009) (explaining on a Rule 12(b)(6) motion to dismiss antitrust claims that "the Court must ensure that plaintiffs have alleged facts to support those elements sufficient to provide the 'heft' to show an entitlement to relief and to 'nudge' plaintiffs' claims over the line from mere[ ] possibility or speculation to plausibility" (quoting Twombly , 550 U.S. at 557, 570, 127 S.Ct. 1955 ) ).

The court's analysis, below, applies this governing standard to defendants' Rule 12(b)(6) dismissal arguments.

III. Analysis

The Class Complaint asserts nine claims against the Mylan Defendants: (1) Sherman Act §§ 1 and 2 violations (Count I); (2) Clayton Act § 3 violations (Count II); (3) conspiracy violating state antitrust statutes (Count III); (4) monopolization violating state antitrust statutes (Count IV); (5) attempted monopolization violating state antitrust statutes (Count V); (6) tying violating state antitrust statutes (Count VI); (7) RICO Act violations (Count VII); (8) violation of state consumer protection laws (Count VIII); and (9) unjust enrichment (Count IX). The Class Complaint asserts just Counts I-V and VII jointly against the Mylan and Pfizer Defendants.

Both the Mylan and Pfizer Defendants move the court to dismiss each claim asserted in the Class Complaint. The court addresses each of defendants' arguments in the subsections, below. The first section addresses whether the Class Complaint states plausible claims of federal and state antitrust violations. The second section discusses whether the class plaintiffs have alleged viable RICO claims. The third section addresses whether the Class Complaint states plausible claims for relief under state consumer protection laws. Finally, the fourth section considers whether the class plaintiffs have stated a claim for unjust enrichment.

A. Antitrust Claims

Defendants assert eight different arguments why the class plaintiffs' factual allegations never state a plausible antitrust claim under either federal or state law. The court addresses each one of the eight arguments, in turn, below.

1. Have the class plaintiffs alleged a plausible tying claim based on the EpiPen 2-Pak?

The Mylan Defendants argue that the Class Complaint fails to allege a plausible tying claim because it never alleges the existence of two distinct products. Instead, the Mylan Defendants contend, the class plaintiffs premise their tying claim on the EpiPen 2-Pak, i.e. selling two EpiPen devices in one package. Defendants assert that this practice-because it involves selling two identical products-is not an unlawful tying arrangement.

Tying is an arrangement involving the sale of "two distinct products or services as a package." Jefferson Parish Hosp. Dist. No. 2 v. Hyde , 466 U.S. 2, 33, 104 S.Ct. 1551, 80 L.Ed.2d 2 (1984) (Brennan, J., concurring), abrogated on other grounds by Ill. Tool Works Inc. v. Indep. Ink, Inc. , 547 U.S. 28, 126 S.Ct. 1281, 164 L.Ed.2d 26 (2006) (further citation omitted). "[T]he essential characteristic of an invalid tying arrangement lies in the seller's exploitation of its control over the tying product to force the buyer into the purchase of a tied product that the buyer either did not want at all, or might have preferred to purchase elsewhere on different terms." Id. at 12, 104 S.Ct. 1551. But "a tying arrangement cannot exist unless two separate product markets have been linked." Id. at 21, 104 S.Ct. 1551. And "the question whether one or two products are involved turns not on the functional relation between them, but rather on the character of the demand for the two items." Id. at 19, 104 S.Ct. 1551 ; see also Eastman Kodak Co. v. Image Tech. Servs., Inc. , 504 U.S. 451, 456, 112 S.Ct. 2072, 119 L.Ed.2d 265 (1992) ("[T]o be considered two distinct products, there must be sufficient consumer demand so that it is efficient for a firm to provide [one] separately from [the other].").

The class plaintiffs respond that they have alleged a tying arrangement involving two separate product markets-one for the primary EAI device, and the other for a "spare" (or "back-up") EAI device. Class Compl. ¶¶ 575-79. The Class Complaint describes how Mylan and others sold the EpiPen individually in the U.S. from 1987 to 2011 without incident. But, in 2011, Mylan imposed the "hard switch," requiring patients to purchase EpiPens in pairs in the EpiPen 2-Pak. The class plaintiffs allege that, before the "hard switch," "[t]here was sufficient independent demand for some patients to either not purchase a second EpiPen at all or to purchase an EpiPen and a cheaper, alternative back-up." Id. ¶ 577. But, after the hard switch, Mylan forced patients to buy two separate devices-the primary EAI device and back-up EAI device-even though "each EpiPen expires annually and the vast majority of EpiPens expire before they can be used." Id. ¶ 577. As the Class Complaint describes: "Consumers no longer had the choice or ability to purchase a back-up or spare device from another manufacturer, or to decline to purchase a second EpiPen based on whether they needed it, chose to purchase it, or were prescribed it by a doctor." Id. ¶ 579.

Viewing these allegations in the class plaintiffs' favor, the Class Complaint alleges a "sufficient consumer demand" in the U.S. to purchase a primary EAI device separately from a back-up device or none at all "so that it is efficient for a firm to provide [one] separately from [the other]." Eastman Kodak Co. , 504 U.S. at 456, 112 S.Ct. 2072 ; see also Multistate Legal Studies, Inc. v. Harcourt Brace Jovanovich Legal & Prof'l Pubs., Inc. , 63 F.3d 1540, 1547-48 (10th Cir. 1995) (holding that the case's summary judgment facts presented a factual dispute whether "enough consumer demand [existed] in Colorado" for one product such that it was efficient to sell the two products separately).

The court recognizes that the class plaintiffs have alleged a tying relationship based on two products that are functionally identical. The Mylan Defendants assert that the two products thus are interchangeable. For example, a patient could use either one of the two EpiPens in a 2-Pak as the primary device and the other one as the back-up device. The Mylan Defendants thus argue that it is not plausible that the primary EAI device and backup EAI device belong to separate markets. Indeed, the Tenth Circuit has defined the "relevant product market in any given case" as one " 'composed of products that have reasonable interchangeability for the purposes for which they are produced-price, use and qualities considered.' " Buccaneer Energy (USA) Inc. v. Gunnison Energy Corp. , 846 F.3d 1297, 1313 (10th Cir. 2017) (quoting SCFC ILC, Inc. v. Visa USA, Inc. , 36 F.3d 958, 966 (10th Cir. 1994) ) (emphasis added). Although the two products here have the same qualities, the Class Complaint defines how patients use them in a functional sense as two separate products. A patient uses one EpiPen as the primary EAI device and the other as the back-up device.

The parties do not cite, and the court's research has not revealed, any tying cases involving identical products with different and distinct uses-what the class plaintiffs allege here. The Mylan Defendants cite two cases where courts refused to find two separate products to support a tying claim, but those cases involved preliminary injunction motions where the factual record failed to demonstrate the existence of two separate product markets. See Metromedia Broad. Corp. v. MGM/UA Entm't Co. , 611 F.Supp. 415, 422-24 (C.D. Cal. 1985) (recognizing that questions existed whether "the demand for first runs [of TV series] is separate from that for reruns," but refusing to "carve up" a copyright for the purposes of licensing "a single intellectual property" because both the first runs and reruns shared the "same copyright and uniqueness," which "was the product from which market power derives"); Paul v. Pulitzer Publ'g Co. , No 74-327C(A), 1974 WL 887, at *5 (E.D. Mo. May 24, 1974) (holding that "different issues of the same newspaper are not separate products" but never discussing whether consumer demand existed for selling weekday editions separately from the Saturday edition).

In contrast here, the Class Complaint asserts facts that plausibly allege two separate product markets-one for EAI primary devices and the other for back-up devices. These allegations are sufficient to state a claim at this stage of the litigation. Ultimately, to prevail on their tying claim, the class plaintiffs must adduce admissible evidence to support a reasonable finding that two separate product markets exist. But, to survive the Motions to Dismiss, plaintiffs need only make plausible factual allegations of two different product markets. They have satisfied that requirement.

2. Have the class plaintiffs alleged plausible exclusive dealing claims based on Mylan's exclusive dealing contracts with PBMs and schools?

The Mylan Defendants assert that the class plaintiffs have failed to allege plausible antitrust claims based on Mylan's exclusive dealing contracts with PBMs and schools. Defendants offer five arguments to support their assertion.

First , the Mylan Defendants argue, the Class Complaint never alleges that Mylan's rebates and discount offers resulted in EpiPen prices below the cost of their production. Six days after the Mylan Defendants filed their Motions to Dismiss the Class Complaint, the court issued a Memorandum and Order in the other of the two separate tracks in this MDL-the Sanofi track. The court's Order granted Mylan's Motion to Dismiss the Sanofi Complaint in part, and denied that motion in part ("the Sanofi Order"). Doc. 98. In the Sanofi Order, the court rejected the same argument asserted here-i.e. , that Sanofi's exclusive dealing claims fail as a matter of law because the Sanofi Complaint never alleges that Mylan's rebate offers resulted in prices that were below its costs to produce the EpiPen. See id. at 10-15. The court recognized that the price-cost test does not apply to bar exclusive dealing claims when price itself is not the clearly predominant mechanism of exclusion. Id. at 12-13 (citing ZF Meritor, LLC v. Eaton Corp. , 696 F.3d 254, 277 (3d Cir. 2012) (further citations omitted) ). And, viewing the allegations in Sanofi's favor, the court concluded that the Sanofi Complaint "does not rely 'solely on the exclusionary effect of [Mylan's] prices' to support its exclusive dealing claim based on Mylan's rebate program." Id. at 13 (quoting ZF Meritor , 696 F.3d at 277 ).

The same is true of the Class Complaint. The Class Complaint alleges that Mylan leveraged its greater-than-90% market share by offering large rebates to PBMs to exclude Auvi-Q from the formularies. Class Compl. ¶ 177. The Class Complaint asserts that no legitimate business reason existed for Mylan's deep conditional rebates except blocking Auvi-Q from the market. Id. ¶ 178. Also, it asserts that Mylan's rebates effectively prevented competitors from accessing formularies of the two largest PBMs-Express Scripts and CVS Caremark-that combine to cover more than 50% of the PBM market in the United States. Id. ¶¶ 162, 168. The Class Complaint alleges that Mylan's conditional rebates unlawfully increased Sanofi's cost to enter the market if it wanted to match Mylan's rebates. Id. ¶ 182. And, the Class Complaint alleges, after Mylan successfully excluded Auvi-Q from coverage, it sent misleading marketing materials to physicians asserting that EpiPen was the "preferred" EAI device for 99% of patients while Auvi-Q was "preferred" for only 2% of patients. According to the class plaintiffs, the marketing materials suggested that the reason for Auvi-Q's exclusion was based on clinical recommendations-and not the large, conditional rebate offers. Id. ¶¶ 232-35. These allegations assert that Mylan's rebate program involved anticompetitive conduct-beyond pricing itself-that was designed to exclude competition in the EAI drug market.

Second , the Mylan Defendants contend that the Class Complaint never alleges that Mylan's rebates harmed the class plaintiffs by excluding Auvi-Q from the market because Sanofi's decision not to compete with the EpiPen was based on other factors, all unrelated to Mylan's conduct. The Mylan Defendants cite a paragraph from the Sanofi Complaint asserting that Sanofi voluntarily recalled Auvi-Q in October 2015 following reports of manufacturing issues. Doc. 95 at 44. But, as the court concluded in the Sanofi Order, the Sanofi Complaint plausibly alleges that Mylan's conduct forced Sanofi to exit the EAI drug market. Doc. 98 at 40. The Class Complaint contains similar allegations. As the court already has held, Mylan's arguments that the voluntary recall-and not Mylan's alleged anticompetitive conduct-caused Sanofi's injuries present a factual dispute that the court cannot resolve on a motion to dismiss. Id. For the same reasons as the Sanofi Order discussed, the court declines to dismiss the class plaintiffs' exclusive dealing claims based on Mylan's argument that Sanofi's decision to exit the EAI market was based on factors other than Mylan's anticompetitive conduct.

Third , the Mylan Defendants assert that the Class Complaint never alleges that Mylan's exclusive dealing contracts harmed competition. The court rejected this same argument in the Sanofi Order. It rejects it again here for the same reasons. The Class Complaint, construed in favor of the class plaintiffs, plausibly alleges that Mylan's anticompetitive conduct harmed competition. The Class Complaint alleges that defendants implemented a pricing scheme that raised the price of the EpiPen from a little over $100 for two EpiPens in 2007 to more than $600 for the same two EpiPens in 2016. Class Compl. ¶¶ 349-60. According to the class plaintiffs, the price increases allowed Mylan to share its monopoly profits with PBMs through larger rebates for excluding competing products. Id. ¶¶ 165-66. Mylan's exclusionary contracts then prevented consumers in a substantial share of the market from accessing or choosing competing EAI devices such as the Auvi-Q and others. Id. at ¶¶ 168, 491. These allegations, if true, are capable of supporting a finding or inference of harm to competition, and thus, they state a plausible antitrust claim.

Fourth , the Mylan Defendants assert that the class plaintiffs' claims based on discounts or rebates Mylan offered to states or state agencies are barred by the Noerr -Pennington doctrine. The Noerr -Pennington doctrine " 'exempts from antitrust liability any legitimate use of the political process by private individuals, even if their intent is to eliminate competition.' " Tal v. Hogan , 453 F.3d 1244, 1257 n.13, 1259-60 (10th Cir. 2006) (quoting Zimomra v. Alamo Rent-A-Car, Inc. , 111 F.3d 1495, 1503 (10th Cir. 1997) ). The scope of the Noerr -Pennington doctrine depends "on the source, context, and nature of the anticompetitive restraint at issue." Allied Tube & Conduit Corp. v. Indian Head, Inc. , 486 U.S. 492, 499, 108 S.Ct. 1931, 100 L.Ed.2d 497 (1988).

But " Noerr -Pennington immunity does not apply if the purported effort to influence or obtain government action is in fact only an attempt to interfere with the business relationships of a competitor." Classic Commc'ns, Inc. v. Rural Tel. Serv. Co. , 956 F.Supp. 910, 917 (D. Kan. 1997) (first citing E. R.R. Presidents Conference v. Noerr Motor Freight, Inc. , 365 U.S. 127, 144, 81 S.Ct. 523, 5 L.Ed.2d 464 (1961) ; then citing Cal. Motor Transp. Co. v. Trucking Unlimited , 404 U.S. 508, 511, 92 S.Ct. 609, 30 L.Ed.2d 642 (1972) ). "This is the so-called 'sham' exception to the Noerr -Pennington doctrine." Id. The sham exception applies "when 'persons use the governmental process -as opposed to the outcome of that process-as an anticompetitive weapon.' " GF Gaming Corp. v. City of Black Hawk , 405 F.3d 876, 884 (10th Cir. 2005) (quoting City of Columbia v. Omni Outdoor Advert., Inc. , 499 U.S. 365, 380, 111 S.Ct. 1344, 113 L.Ed.2d 382 (1991) ). "The exception thus 'involves a defendant whose activities are not genuinely aimed at procuring favorable government action at all,' such as a defendant who files 'frivolous objections to the license application of a competitor, with no expectation of achieving denial of the license but simply in order to impose expense and delay.' " Id. (quoting City of Columbia , 499 U.S. at 380, 111 S.Ct. 1344 ).

In the Sanofi Order, the court held that the Noerr -Pennington doctrine barred Sanofi's exclusive dealing claims based on Mylan's discounts or rebates to state-based Medicaid agencies. Doc. 98 at 22-24. The court reasoned that Sanofi's allegations accused Mylan of using the outcome of the government process-i.e. , exclusion of Auvi-Q from the drug formularies-not the process itself , to harm a competitor. Id. at 22. Thus, the court concluded, Noerr -Pennington immunity applied to Sanofi's claims based on discounts or rebates offered to state-based Medicaid agencies. Id.

The class plaintiffs argue the court should reach a different result here because, they contend, the Class Complaint's allegations differ from Sanofi's. First, the class plaintiffs contend that their antitrust claims are premised on Mylan's misclassification of the EpiPen and that this misclassification influenced decisions by state-based Medicaid agencies to exclude Auvi-Q. The Class Complaint alleges that Mylan's misclassification of the EpiPen allowed it to "amass millions of dollars each year in unpaid rebates to cash-strapped state Medicaid agencies." Class Compl. ¶ 187. And, according to the Class Complaint, these "outstanding underpaid rebates led benefit managers to continue favoring the EpiPen over competitors in the expectation of receiving a large make-up payment if and when Mylan was forced to classify the EpiPen as a brand." Id. ¶ 188. The class plaintiffs assert that the Noerr -Pennington doctrine does not shield Mylan's misrepresentations about the EpiPen's classification from antitrust liability because "[m]isrepresentations, condoned in the political arena, are not immunized when used in the adjudicatory process." Cal. Motor Transp. , 404 U.S. at 513, 92 S.Ct. 609.

The court disagrees that the class plaintiffs' allegation about the EpiPen's misclassification-in this one paragraph of their 1,429 paragraph Class Complaint-places the claim outside of Noerr -Pennington immunity. Indeed, "[n]ot every fraudulent misrepresentation during an adjudicative or administrative proceeding can give rise to antitrust liability." Mercatus Grp., LLC v. Lake Forest Hosp. , 641 F.3d 834, 843 (7th Cir. 2011). "[A] misrepresentation renders an adjudicative proceeding a sham only if the misrepresentation (1) was intentionally made, with knowledge of its falsity; and (2) was material, in the sense that it actually altered the outcome of the proceeding." Id. at 843 ; see also Cheminor Drugs, Ltd. v. Ethyl Corp. , 168 F.3d 119, 123 (3d Cir. 1999) ("While we do not condone misrepresentations in a judicial setting, neither will we deprive litigants of immunity derived from the First Amendment's right to petition the government if the alleged misrepresentations do not affect the core of the litigant's ... case.").

Here, the class plaintiffs' allegation never asserts explicitly that the misclassification caused any state-based Medicaid agencies to exclude EpiPen rivals from the formularies. Instead, the allegation refers generally to "benefit managers." And it recites that these benefit managers continued to "favor" the EpiPen over competitors. Also, the allegation asserts that the benefit managers knew about the misclassification and thus anticipated a large make-up payment when Mylan was forced to reclassify the EpiPen. Thus, according to the allegation, the benefit managers never made their decisions based on any false representations that Mylan made to them. To the contrary, the allegation asserts that the benefit managers understood that Mylan had misclassified the EpiPen. So, nothing about the misclassification affected the decision-making abilities of benefit managers when they chose which EAI devices to include in the formularies. Construed in the class plaintiffs' favor, the exclusive dealing allegations based on Mylan's discounts or rebates to state-based Medicaid agencies assert that Mylan's conduct violated the antitrust laws by offering the rebates in exchange for exclusivity. The Noerr -Pennington doctrine precludes liability for this type of conduct, even if the intent was to exclude competition. Thus, the Class Complaint fails to allege a plausible antitrust claim based on Mylan's discounts or rebates to state-based Medicaid agencies.

Finally , the Mylan Defendants argue that the Class Complaint never alleges that Mylan's EpiPen4Schools program foreclosed competitors from a substantial share of the relevant market. To assert a plausible exclusive dealing claim, a plaintiff must plead facts capable of supporting a finding or inference that the "probable effect" of "performance of the contract will foreclose competition in a substantial share of the line of commerce affected." Tampa Elec. Co. v. Nashville Coal Co. , 365 U.S. 320, 327, 81 S.Ct. 623, 5 L.Ed.2d 580 (1961) ; see also Perington Wholesale, Inc. v. Burger King Corp. , 631 F.2d 1369, 1374 (10th Cir. 1979) ("Thus, a complaining trader must allege and prove that a particular arrangement unreasonably restricts the opportunities of the seller's competitors to market their product.").

The Supreme Court has instructed lower courts "[t]o determine substantiality in a given case" by "weigh[ing] the probable effect of the contract on the relevant area of effective competition, taking into account the relative strength of the parties, the proportionate volume of commerce involved in relation to the total volume of commerce in the relevant market area, and the probable immediate and future effects which pre-emption of that share of the market might have on effective competition therein." Tampa Elec. , 365 U.S. at 329, 81 S.Ct. 623. When considering whether the contract at issue in Tampa Electric tended to foreclose a substantial volume of competition, the Supreme Court considered several things. Id. at 334-35, 81 S.Ct. 623. They include the relative dominance of a seller's position in the market, whether the market has "myriad outlets with substantial sales volume," the prevalence in the industry of exclusive contracts, the duration of the contract, and the existence of any pro-competitive justifications for the contract. Id.

The class plaintiffs assert that the Class Complaint plausibly alleges facts capable of supporting a finding or inference of substantial market foreclosure. The Class Complaint alleges that Mylan's exclusionary contracts with PBMs prevented competitors from accessing formularies covering more than 50% of the PBM market in the U.S. Also, the Class Complaint alleges that Mylan created a substantial, additional need for EpiPens by adding school districts to the market for EAI devices. Class Compl. ¶ 208. More than 67,000 school districts now purchase EpiPens, and the districts usually are "bulk" purchasers. Id. For example, the public schools in Fairfax County, Virginia, order about 1,100 EpiPen 2-Paks annually to have them on hand for their 180,000 students. Id. The Class Complaint also alleges that Mylan gained another advantage by opening up the school market-gaining access to nursing staff and creating familiarity with the EpiPen among parents. Id. ¶ 209.

Although these allegations never assert definitively that the E