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In re Suboxone

United States District Court for the Eastern District of Pennsylvania

September 26, 2019, Decided; September 27, 2019, Filed

MDL NO. 2445; 13-md-2445

Opinion

 [*25]  MEMORANDUM

The Plaintiffs in this multi-district litigation case allege anticompetitive conduct by Defendant Reckitt Benckiser, Inc. ("Reckitt")1 in connection with their Suboxone product—a drug used to combat opioid addiction. Plaintiffs' claims focus on a relatively new theory of antitrust liability, referred to as a "product hop," pursuant to the unique regulatory and statutory scheme that governs the marketing and distribution of pharmaceutical drugs. Under this theory, a pharmaceutical company makes modest reformulations to a brand-name drug prior to the expiration of its market exclusivity for the purpose of stymieing generic competition and preserving monopoly profits.

 [*26]  The Plaintiffs are the Direct Purchasers of Suboxone ("Direct Purchasers" or "DPPs") and the End Payors of Suboxone ("End Payors" or "EPPs"), who claim that Reckitt switched from sublingual Suboxone tablets to a sublingual Suboxone film for the purpose of foreclosing generic competition. According to Plaintiffs, this switch (the "product [**2]  hop") was accompanied by Reckitt disparaging the tablet through fabricated safety concerns and ultimately removing Suboxone tablets from the market just as generic Suboxone tablets were able to begin competing. Reckitt is also alleged to have manipulated FDA regulations to delay the entry of generic Suboxone onto the market, thereby unlawfully maintaining a monopoly in violation of Section 2 of the Sherman Act. According to all Plaintiffs, Reckitt's conduct foreclosed competition and resulted in the overpayment for Suboxone. Reckitt acknowledges the product switch, but strenuously asserts that the switch was done to market and sell an improved and superior product.

Both the DPPs and the EPPs have now sought class certification. For the following reasons, I will certify the DPP class under Federal Rule of Civil Procedure 23(b)(3), deny certification of the EPP class under Federal Rule of Civil Procedure 23(b)(2), and grant certification of the EPP class under Federal Rule of Civil Procedure 23(c)(4).

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421 F. Supp. 3d 12 *; 2019 U.S. Dist. LEXIS 166524 **; 2019-2 Trade Cas. (CCH) P80,936; 2019 WL 4735520

IN RE: SUBOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALAXONE) ANTITRUST LITIGATION. THIS DOCUMENT APPLIES TO ALL ACTIONS

Subsequent History: Affirmed by In re Suboxone (Buprenorphine Hydrochlorine & Naloxone) Antitrust Litig., 2020 U.S. App. LEXIS 23721 (3d Cir. Pa., July 28, 2020)

Prior History: In re Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litig., 64 F. Supp. 3d 665, 2014 U.S. Dist. LEXIS 167204 (E.D. Pa., Dec. 3, 2014)

CORE TERMS

tablets, film, certification, antitrust, anticompetitive, branded, predominance, calculating, patients, switch, methodology, manufacturers, clinics, reliable, wholesalers, injunctive, bypass, class-wide, quotations, consumer, prescriptions, overcharge, but-for, deceptive, adequacy, monopoly, buprenorphine, chargebacks, brand-name, withdrawal