In re Epipen (Epinephrine Injection, USP) Mktg., Sales Practices & Antitrust Litig.

• Decision Date: 17 December 2020
• Docket Number: Case No. 17-md-2785-DDC-TJJ,MDL No. 2785
• Citation: 507 F.Supp.3d 1289
• Parties: IN RE: EPIPEN (EPINEPHRINE INJECTION, USP) MARKETING, SALES PRACTICES AND ANTITRUST LITIGATION (This Document Applies to the Sanofi Case)
• Court: U.S. District Court — District of Kansas

507 F.Supp.3d 1289

IN RE: EPIPEN (EPINEPHRINE INJECTION, USP) MARKETING, SALES PRACTICES AND ANTITRUST LITIGATION (This Document Applies to the Sanofi Case)

MDL No. 2785

Case No. 17-md-2785-DDC-TJJ

United States District Court, D. Kansas.

Signed December 17, 2020

MEMORANDUM AND ORDER

Daniel D. Crabtree, United States District Judge

Plaintiff Sanofi-Aventis U.S. LLC ("Sanofi") filed a lawsuit against defendants Mylan, Inc. and Mylan Specialty, L.P. (collectively "Mylan") in the District of New Jersey on April 24, 2017. Complaint, Sanofi-Aventis U.S. LLC v. Mylan Inc., et al. , Case No. 3:17-cv-02763-FLW-TJB, 2017 WL 1455371 (D.N.J. Apr. 24, 2017), ECF 1 ("the Sanofi case"). Sanofi is a pharmaceutical company who alleges that Mylan, distributor of the EpiPen, engaged in a variety of anticompetitive conduct designed to prevent Auvi-Q—a rival product once sold by Sanofi—from gaining access to the epinephrine autoinjector market, and aimed to prevent consumers from acquiring Auvi-Q. Sanofi asserts three claims against Mylan under Section 2 of the Sherman Antitrust Act: (1) monopolization through exclusive dealing; (2) deceptive conduct to further monopolization; and (3) an overall scheme to monopolize. Sanofi brings this action only for itself, and not on behalf of any other plaintiffs or putative class members.

In August 2017, the Judicial Panel on Multidistrict Litigation ("JPML") created MDL 2785, In re: EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation (the "MDL"). See Doc. 1 (JMPL Transfer Order). The JMPL assigned the MDL to our court, and it transferred several actions filed in other Judicial Districts, including the Sanofi case, to our court for "coordinated or consolidated pretrial proceedings." Id. at 4.

But for the Sanofi case, all the other cases pending in the MDL are brought by individual consumers or third-party payors who allege they purchased EpiPens for use by themselves, their families, or their members, employees, insureds, participants, or beneficiaries. These consumer plaintiffs asserted that defendants—sellers and manufacturers of the EpiPen—violated federal and state antitrust laws, the federal RICO Act, and various state consumer protection laws.¹ And, these consumer plaintiffs successfully sought certification of two classes asserting state antitrust law violations and RICO claims. See Doc. 2018-1 at 126–27 (certifying two classes and providing class definitions for those two classes).

Because the Sanofi case differs from the MDL's other cases, the court previously concluded that the consumer class cases and the Sanofi case warranted separate litigation tracks. Doc. 42 at 3. Thus, the court established two distinct tracks in this MDL—i.e. , one for the consumer class cases and one for the Sanofi case. Id. at 3, 5.

After the Sanofi case's transfer to this court, Mylan filed an "Answer, Affirmative Defenses, and Counterclaims." Doc. 112. Mylan Specialty, L.P. ("Mylan Specialty")—as counterclaim plaintiff—asserts two claims against Sanofi, as counterclaim defendant: (1) commercial disparagement and false advertising violating the Lanham Act, 15 U.S.C. § 1125(a), and (2) common law unfair competition. Id. at 49, 52.²

This matter now comes before the court on the parties’ cross motions for summary judgment in the Sanofi case. Mylan has filed a Motion for Summary Judgment (Doc. 1673 (publicly-filed redaction version), Doc. 1660-1 (version filed under seal)), with a Memorandum in Support (Doc. 1673-1 (publicly-filed redaction version), Doc. 1660-2 (version filed under seal)), seeking summary judgment against all three of Sanofi's Sherman Antitrust Act claims. Sanofi has filed a Memorandum of Law in Opposition to that motion (Doc. 1814 (publicly-filed redacted version), Doc. 1820-1 (version filed under seal)), and Mylan has submitted a Reply (Doc. 1883 (publicly-filed redacted version), Doc. 1882-1 (version filed under seal)).³

Sanofi's Motion for Summary Judgment (Doc. 1691), and Memorandum in Support (Doc. 1692 (publicly-filed redaction version), Doc. 1686-1 (version filed under seal)), seeks summary judgment in its favor on one element of its Sherman Antitrust Act claims and against Mylan Specialty's Counterclaim. Specifically, Sanofi asks the court to enter judgment as a matter of law that: (1) the relevant market consists of epinephrine auto-injector devices in the United States, and (2) Mylan possessed and exercised monopoly power in that market. Id. at 2. And, Sanofi asks the court to enter summary judgment against Mylan Specialty's Counterclaim asserting (1) violations of the Lanham Act, and (2) unfair competition. Id. Mylan has filed a Memorandum of Points and Authorities in Opposition to Sanofi's Motion for Summary Judgment (Doc. 1813 (publicly-filed redacted version), Doc. 1805-1 (version filed under seal). And Sanofi has submitted a Reply (Doc. 1871 publicly-filed redacted version), Doc. 1872-1 (version filed under seal).

The court has considered the parties’ thorough and well-presented arguments. And, the court now is prepared to decide their cross motions for summary judgment.

I. Undisputed Facts

The following facts are either uncontroverted, or, where genuinely controverted, are viewed in the light most favorable to the party opposing summary judgment. Scott v. Harris , 550 U.S. 372, 378–80, 127 S.Ct. 1769, 167 L.Ed.2d 686 (2007).

The Use of EAI Drug Devices to Treat Anaphylaxis

Anaphylaxis is a life-threatening allergic reaction caused by exposure to allergens such as foods, insect stings, pets, latex, or medications. Doc. 1821-2 at 4–5 (Michelis Expert Report ¶¶ 9–10). Between roughly 2% and 5% of the U.S. population is at risk for anaphylaxis. Id. at 6 (Michelis Expert Report ¶ 12). Epinephrine is the first-line treatment for anaphylaxis. Id. at 9 (Michelis Expert Report ¶ 19); see also Doc. 1815-6 at 19 (Blaiss Expert Report ¶ 5.4). Other products, such as antihistamines, are not proper substitutes for epinephrine when treating anaphylaxis. Id. (explaining that "treatment with antihistamines does not relieve or prevent all of the pathophysiological symptoms of anaphylaxis, including the more serious complications such as airway obstruction, hypotension, and shock").

An epinephrine auto-injector ("EAI" or "EAI device") is a medical device used to inject a fixed dose of epinephrine through a spring-activated needle. Id. at 10–11 (Blaiss Expert Report ¶ 5.1). Physicians prescribe EAI devices to patients at risk for anaphylaxis. Id. ; see also Doc. 1821-2 at 9 (Michelis Expert Report ¶ 19). Over the last 20 years, food-related allergies have increased, increasing the need for access to EAI devices. Doc. 1815-6 at 8 (Blaiss Expert Report ¶ 4.0). Patients or their caregivers should carry an EAI device at all times to provide rapid treatment should an anaphylactic episode occur. Doc. 1821-2 at 7, 9 (Michelis Expert Report ¶¶ 13, 19). But, failing to carry an EAI device during an anaphylactic episode is a documented problem. Id. at 10–11 (Michelis Expert Report ¶ 22).

It is possible to administer epinephrine without an EAI device through use of pre-filled syringes of epinephrine or vials and syringes. Id. at 11 (Michelis Expert Report ¶ 24). But, these methods are not preferred in situations of self-administration because usually the person administrating the epinephrine is a layperson who lacks medical training. Id. ; see also Doc. 1815-6 at 18 (Blaiss Expert Report ¶ 5.2.3) ("While it is not practical or recommended for a patient to self-administer epinephrine using vials and syringes during anaphylaxis, physicians and other medical professionals routinely treat patients for anaphylaxis using vials and syringes in medical offices, hospitals, or other institutional settings."). Also, using vials and syringes to administer epinephrine may cause an incorrect dosage because "syringes do not automatically dispense the medication, and there is a chance that the full dose of medication will not be injected." Doc. 1821-2 at 11 (Michelis Expert Report ¶ 24).

Mylan's Sale and Distribution of the EpiPen

Defendant Mylan, Inc. is a global healthcare company whose affiliates develop and market branded and generic prescription drugs. Defendant Mylan Specialty, L.P. is a subsidiary of Mylan, Inc. Mylan Specialty develops, manufactures, and markets branded specialty prescription drug products.

In 2007, Mylan acquired Dey Pharma L.P.—the predecessor to Mylan Specialty. Dey Pharma L.P. owned the rights to market EpiPen® and EpiPen Jr.® Auto-Injectors (collectively "EpiPen"). Meridian Medical Technologies, Inc. ("Meridian"), a subsidiary of Pfizer, manufactures the EpiPen. Under Dey Pharma L.P.’s Supply Agreement with Meridian, Mylan has the exclusive right to market, distribute, and sell EpiPen in the United States.

Introduced in the 1980s, EpiPen was the first EAI available on the market. An EpiPen is shaped like a pen. A patient administers the EpiPen by removing a cap and swinging it against the thigh, which causes the needle to come out and inject epinephrine. After three seconds, the patient removes the device and a plastic shield covers the needle. After Mylan acquired the rights to the EpiPen, it invested substantially in marketing the product to increase public awareness about the risks and treatment of anaphylaxis. Under the Supply Agreement with Meridian, Mylan's exclusive right to market and sell the EpiPen in the United States will terminate on December 31, 2020.⁴

Sanofi Launches A Rival EAI Device, Auvi-Q

Sanofi is one of the world's largest pharmaceutical companies. It is headquartered in Paris, France. The named plaintiff in this lawsuit—Sanofi-Aventis U.S. LLC—is Sanofi's U.S. subsidiary.⁵ In 2009, Sanofi secured a license to market and sell Auvi-Q® ("Auvi-Q"), an EAI device developed by Intelliject. Sanofi agreed to pay Intelliject [Redacted] before the product launched and a percentage of royalties based on annual net sales as well as certain "milestone...