County of Harris, Texas v. Eli Lilly And Company

CourtDistrict Court, S.D. Texas
DecidedFebruary 16, 2022
Docket4:19-cv-04994
StatusUnknown

This text of County of Harris, Texas v. Eli Lilly And Company (County of Harris, Texas v. Eli Lilly And Company) is published on Counsel Stack Legal Research, covering District Court, S.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
County of Harris, Texas v. Eli Lilly And Company, (S.D. Tex. 2022).

Opinion

UNITED STATES DISTRICT COURT February 16, 2022 SOUTHERN DISTRICT OF TEXAS Nathan Ochsner, Clerk HOUSTON DIVISION

HARRIS COUNTY, TEXAS, § § Plaintiff, § § v. § CIVIL ACTION H-19-4994 § ELI LILLY AND COMPANY et al., § § Defendants. §

MEMORANDUM OPINION AND ORDER Pending before the court is Defendant OptumRx Inc.’s (“OptumRx”) motion to dismiss. Dkt. 148. Having considered the motion, response, reply, briefings on supplemental authority, and applicable law, the court is of the opinion that the motion should be GRANTED. I. BACKGROUND In its Fourth Amended Complaint (the “FAC”), the County alleges that a price-fixing conspiracy involving fifteen entities that either manufacture diabetes medications or manage and negotiate certain pharmacy benefits is behind the dramatic rise in drug costs. See Dkt. 127. In particular, the County sues Defendants Eli Lilly, Novo Nordisk, and Sanofi (the “Manufacturer Defendants”) and CVS Caremark, Express Scripts, OptumRx, and Aetna Rx (the “PBM Defendants”). Though only OptumRx has thus far moved to dismiss the FAC, the court will briefly review the general contours of the price-fixing conspiracy allegedly behind the rising costs of diabetes medications and discuss the relationships between the Manufacturer Defendants and the PBM Defendants. A. The Insulin Pricing Scheme According to the FAC, Eli Lilly joins Novo Nordisk and Sanofi as the three principal companies that manufacture, promote, and distribute pharmaceutical drugs, including diabetes medications and various insulins. Id. 8 ¶ 2. Together, these Manufacturer Defendants produce the

“vast majority” of diabetes medications on which approximately six million people across the country rely. See id. 7–8 ¶¶ 1–2. Though they only cost Manufacturer Defendants $5 to produce (and were marketed for $20 during the 1990s), today’s insulins are priced between $300 and $700. Id. 8 ¶ 5. Since 2003, the reported price of certain insulins has far outpaced inflation; some have increased by more than 1000%. Id. 50 ¶ 234. By 2016, the average price per month of the four most popular types of insulin rose to $450. Id. ¶ 235. For one drug, Humulin R (500U/ML), Eli Lilly has raised the price from $165 to $1,784 since 1999. Id. ¶ 236. For another, Humalog, Eli Lilly has raised the reported price for a package of the medication from less than $200 to $663 since 2008. Id. 52 ¶ 237. The County alleges that Manufacturer Defendants have “in lockstep raised the reported prices of their respective diabetes drugs.” Id. 8 ¶ 4, 56–61 ¶¶ 243–50.

The County also sues the PBM Defendants that “manage the pharmacy benefits for the vast majority of individuals in the United States” and “establish national formularies”—or lists of approved drugs for a given health plan—"that...set the baseline for which diabetes medications are covered by insurance and which are not.” Id. 8 ¶ 3, 20 ¶ 78, 95 ¶ 420. The PBM Defendants “contract with payors” like the County. Id. 85 ¶ 367. A PBM develops the payor’s drug formulary, processes claims, creates a network of retail pharmacies, sets the prices in coordination with the Manufacturers that the payor will pay for prescription drugs, and is paid by the payor to reimburse pharmacies for the drugs utilized by the payor’s beneficiaries. Id. 63 ¶ 265. Harris County “relies on PBMs as administrative agents, for the alleged purposes of limiting administrative burden and controlling pharmaceutical drugs costs.” Id. 92 ¶ 406. The County alleges that together, Manufacturer Defendants and PBM Defendants conspired “to create a secret spread”—known as the Insulin Pricing Scheme—"between the

reported price for diabetic treatments (on which Harris County’s payments are based) and the true net price of those same drugs.” Id. 10 ¶ 10. In that sense, the “Insulin Pricing Scheme was designed to, and did, encourage others, including diabetics and payors...to advocate the use of [Manufacturer Defendants’] products and pay for those diabetes medications based on a fraudulently inflated price.” Id. 121 ¶ 533. At the heart of this conspiracy are what the County terms “Manufacturer Payments”— refunds (or kickbacks) in the form of “rebates, discounts, credits, concession fees, and the like that serve as a ‘quid pro quo for formulary inclusion.’” Id. 11 ¶ 16. What payors and their health plans pay for a prescription drug is “directly tied to the reported price” that the Manufacturer Defendants and PBM Defendants have allegedly fixed. See id. ¶ 266, 62 ¶¶ 256–63. PBMs also contract with

a network of retail pharmacies, which the PBMs pay after they dispense drugs to patients. Id. 64 ¶ 267. However, the amount PBMs pay to pharmacies is “not the same as the amount paid by the payor.” Id. ¶ 268. Instead, payment is “negotiated...and not disclosed.” Id. Sometimes, though, the PBM and the pharmacy operate as part of a larger whole, such as when the PBM owns a mail- order or specialty pharmacy. See id. ¶ 269. In those scenarios, the mail order pharmacy purchases and takes possession of the prescription drugs and directly supplies the drugs to patients by mail. Id. But, as a general matter, the PBMs “negotiate the price that payors pay for a prescription drug; they separately negotiate a different price that pharmacies receive for that same drug; and they also negotiate the amount the manufacturers pay back to the PBM for each drug sold.” Id. ¶ 273. Here is how the conspiracy between the Manufacturer Defendants and the PBM Defendants allegedly works: Manufacturer Defendants “artificially and willingly raise their reported prices” to gain formulary access “and then secretly refund a significant portion of that price back to PBM Defendants.” Id. 11 ¶ 16. The PBM Defendants then grant formulary status

based upon the highest inflated price and the largest refund amount. Id. ¶ 17. The Insulin Pricing Scheme enables Manufacturer Defendants “to buy their preferred formulary position—which significantly increases their revenue—without sacrificing their profit margins.” Id. ¶ 18. At the same time, it enables PBM Defendants to profit from the inflated reported prices by retaining a significant percentage of the secret refund payments and “pocketing an additional pricing spread between what a payor pays the PBM for an insulin script based on the inflated price and a lower price that the PBM reimburses the pharmacy for the same drug.” Id. 11–12 ¶ 19. The PBM Defendants also profit by using those same artificial prices in their own mail-order pharmacies and “charging pharmacies hidden fees based on the inflated price.” Id. According to the County, certain professional associations and conferences facilitate the

conspiracy. For example, each Manufacturer Defendant is a member of the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and “has routinely communicated through PhRMA’s meetings and platforms in furtherance of the alleged Insulin Pricing Scheme.” Id. 68 ¶ 289. PBM and Manufacturer Defendants also use trade associations and industry conferences to “routinely communicate” with one another. See id. ¶ 291. One conference, the Pharmaceutical Care Management Association (“PCMA”), served as a central meeting place for the Insulin Pricing Scheme. See id. 69 ¶ 294. The current PCMA board includes executives from several PBM Defendants. Id. ¶ 293. All PBM Defendants are “members” of the PCMA, and all Manufacturer Defendants are “affiliate members” of the organization. Id. ¶ 295. But the Manufacturer Defendants are more than just mere affiliate members. According to the County, they are “Presidential Sponsors” of the PCMA conferences. Id. ¶ 297. As “Presidential Sponsors,” the Manufacturer Defendants

hosted “private meeting rooms” that offered “excellent opportunities for...one-on-one interactions between PBM and pharma executives.” Id. ¶ 298.

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County of Harris, Texas v. Eli Lilly And Company, Counsel Stack Legal Research, https://law.counselstack.com/opinion/county-of-harris-texas-v-eli-lilly-and-company-txsd-2022.