Lawsuit Filed Against Sanofi, Novo Nordisk & Eli Lilly
Mar 3, 2017 22:13:39 GMT -5
sportsrancho, mannontop2, and 4 more like this
Post by mango on Mar 3, 2017 22:13:39 GMT -5
I politely ask the moderators to allow this thread to remain in All About MannKind because it is important for everyone to be able to see this information that they otherwise might not.
The Federal Class Action lawsuit against Sanofi, Novo Nordisk and Eli Lilly was filed on 1/30/2017 on charges of colluding in insulin price fixing, among other things. The web of corruption that runs among these three companies is an intricate one.
This thread is dedicated to the discussion on the Class Action filed against Sanofi, Novo Nordisk and Eli Lilly.
This filing contains an incredible, insightful view into the inner-workings of the racketeering played out by Sanofi, Novo Nordisk and Eli Lilly. This is only 169 pages, but I have only read the Introduction and this particular RICO section so far. All I can say is WOW, they are F_ _ _ ed! The evidence is overwhelming just in this section alone. What a grand and complex scheme these injectable insulin cartels have orchestrated. I would without a doubt say the 2017 Type 2 Diabetes Consensus Statement was orchestrated with corruption. Sanofi, Novo Nordisk and Eli Lilly's names are all over the disclosures, frightening actually the prevalence is.
Below is the Class Action plaintiffs and defendants, along with the particular Sanofi RICO section that I read and wanted to share. The other two companies' RICO sections follow Sanofi's if you wish to click the link and read more.
If you skim read or skip through it you will most certainly not get the details. This is worth the effort and time because this is extremely important.
LINK TO THE FILING:
cdn1.nyt.com/science/01-30-17_Insulin_Class_Action_Complaint_Hagens_Berman.PDF
Case 1:17-cv-10158 Document 1 Filed 01/30/17 Page 1 of 169
UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS
DONALD CHAIRES, GEORGE DENAULT, JANE DOE, JOHN DOE, BRITTANY GILLELAND, GERALD GIRARD, SARA HASSELBACH, LINDSEY KINHAN, JOSEPH MCLAUGHLIN, MATTHEW TEACHMAN, and KARYN WOFFORD,
Plaintiffs,
v.
SANOFI U.S., NOVO NORDISK INC., and ELI LILLY AND COMPANY,
Defendants.
No. 1:17-cv-10158
DEMAND FOR JURY TRIAL
CLASS ACTION COMPLAINT
VIII. CLAIMS FOR RELIEF
COUNT ONE
VIOLATION OF THE RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS ACT (“RICO”), 18 U.S.C. § 1961, ET SEQ.
164. Plaintiffs Chaires, Jane Doe, Gilleland, Girard, Hasselbach, McLaughlin, and Wofford hereby incorporate by reference the allegations contained in the preceding paragraphs of this complaint.
165. This claim is brought on behalf of the class against Sanofi for actual damages, treble damages, and equitable relief under 18 U.S.C. § 1964 for violations of 18 U.S.C. § 1962, et seq.
166. Defendant is a “person” within the meaning of 18 U.S.C. § 1961(3) who conducted the affairs of an enterprise through a pattern of racketeering activity, in violation of 18 U.S.C. § 1962(c).
167. Plaintiffs and the members of the class are each “persons,” as that term is defined in 18 U.S.C. § 1961(3) who were injured in their business or property as a result of Sanofi’s wrongful conduct.
A. The Lantus Pricing Enterprise
168. Under 18 U.S.C. § 1961(4) a RICO “enterprise” may be an association-in-fact that, although it has no formal legal structure, has (i) a common purpose, (ii) relationships among those associated with the enterprise, and (iii) longevity sufficient to pursue the enterprise’s purpose.
169. Sanofi formed just such an
association-in-fact enterprise—sometimes referred to in this complaint as the Lantus Pricing Enterprise.
The Lantus Pricing Enterprise consists of
(a) Sanofi, including its employees and agents;
(b) the PBM CVS Caremark, including its employees and agents;
(c) the PBM Express Scripts, including its employees and agents; and
(d) the PBM OptumRx, including its employees and agents.
170. The Lantus Pricing Enterprise is an ongoing and continuing business organization consisting of “persons” within the meaning of 18 U.S.C. § 1961(3) that created and maintained systematic links for a common purpose: to secure an exclusive, or at least favorable, formulary position for Sanofi’s long-acting analog insulin product, Lantus, as a treatment for type 1 and 2 diabetes to the exclusion or detriment of competitor products and consumers.
171. To accomplish this purpose, the Lantus Pricing Enterprise periodically and systematically inflated the benchmark price of Lantus and represented—either affirmatively or through half-truths and omissions—to the general public, health care payers, and consumers, including Plaintiffs and the class, that Lantus’ benchmark price fairly and accurately reflected the actual cost of this drug. The Lantus Pricing Enterprise concealed from the public, health care payers, and consumers, like Plaintiffs and the class members, the existence and amount of steep rebates Sanofi gave to the PBMs. These rebates were worth at least 25% of the benchmark price. The Lantus Pricing Enterprise also concealed from the public the purpose of these rebates: The difference between the benchmark price and the real price of Lantus negotiated by the PBMs resulted in increased profits for the PBMs. These large rebates served to ensure that the PBMs would place, and maintain, Lantus in a preferred or favorable position on the PBMs’ formularies. By securing a favorable position on the formulary, the Lantus Pricing Enterprise ensured that a larger number of Lantus prescriptions would be written and filled. This scheme translated into higher sales (and therefore profits) for Sanofi and larger spreads for the PBMs.
172. The persons engaged in the Lantus Pricing Enterprise are systematically linked through contractual relationships, financial ties, and continuing coordination of activities, as spearheaded by Sanofi. There is regular communication between Sanofi and each of the PBMs, in which information is shared. Typically, this communication occurred, and continues to occur, through the use of the wires and the mail in which Sanofi and the PBMs share information regarding the Lantus benchmark price and discuss and agree on rebate amounts. Sanofi and the PBMs functioned as a continuing unit for the purposes of implementing the Lantus pricing scheme and, when issues arise during the scheme, each agreed to take actions to hide the scheme and continue its existence.
173. At all relevant times, CVS Caremark was aware of Sanofi’s conduct, was a knowing and willing participant in that conduct, and reaped profits from that conduct. CVS Caremark struck rebate deals with Sanofi to conceal the true price of Lantus and profit from the inflated rebates. CVS Caremark represented to the public that the rebates it negotiated saved health care payers and their plan members (including Plaintiffs and members of the class) money on their prescription needs. But it knew that the rebates did not actually decrease the cost of Lantus for consumers, because the published benchmark price was falsely inflated. CVS Caremark also knew, but did not disclose, that the other PBMs—Express Scripts and OptumRx—were engaged in the same rebating scheme, to the detriment of consumers. But for the Lantus Pricing Enterprise’s unlawful fraud, CVS Caremark would have had the incentive to disclose the deceit by Sanofi, thereby forcing competition on real price. By failing to disclose this information, CVS Caremark perpetuated the Lantus Pricing Enterprise’s scheme, and reaped substantial profits.
174. At all relevant times, Express Scripts was aware of Sanofi’s conduct, was a knowing and willing participant in that conduct, and reaped profits from that conduct. Express Scripts struck rebate deals with Sanofi to conceal the true price of Lantus and profit from the inflated rebates. Express Scripts represented to the public that the rebates it negotiated saved health care payers and their plan members (including Plaintiffs and members of the class) money on their prescription needs. But it knew that the rebates did not actually decrease the cost of Lantus for consumers, because the published benchmark price was falsely inflated. Express Scripts also knew, but did not disclose, that the other PBMs—CVS Caremark and OptumRx— were engaged in the same rebating scheme, to the detriment of consumers. But for the Lantus Pricing Enterprise’s unlawful fraud, Express Scripts would have been incentivized to disclose the deceit by its competitors, thereby obtaining a competitive advantage. By failing to disclose this information, Express Scripts perpetuated the Lantus Pricing Enterprise’s scheme, and reaped substantial profits.
175. At all relevant times, OptumRx was aware of Sanofi’s conduct, was a knowing and willing participant in that conduct, and reaped profits from that conduct. OptumRx struck rebate deals with Sanofi to conceal the true price of Lantus and profit from the inflated rebates. OptumRx represented to the public that the rebates it negotiated saved health care payers and their plan members (including Plaintiffs and members of the class) money on their prescription needs. But it knew that the rebates did not actually decrease the cost of Lantus for consumers, because the published benchmark price was falsely inflated. OptumRx also knew, but did not disclose, that the other PBMs—CVS Caremark and Express Scripts—were engaged in the same rebating scheme, to the detriment of consumers. But for the Lantus Pricing Enterprise’s unlawful fraud, OptumRx would have been incentivized to disclose the deceit by its competitors, thereby obtaining a competitive advantage. By failing to disclose this information, OptumRx perpetuated the Lantus Pricing Enterprise’s scheme, and reaped substantial profits.
176. Furthermore, as public scrutiny, media coverage, and congressional investigations have focused on the rapidly-inflating prices of lifesaving drugs—including insulin—the PBMs did not challenge Sanofi’s reported benchmark prices, terminate their role in the Lantus Pricing Enterprise, nor disclose publicly that the Lantus benchmark price did not accurately reflect the price actually paid for the drug.
177. CVS Caremark, Express Scripts, and OptumRx participated in the conduct of the Lantus Pricing Enterprise, sharing the common purpose of securing exclusive or favorable formulary position for Lantus, through a pattern of racketeering activity within the meaning of 18 U.S.C. §§ 1961(1) and (5), which includes multiple instances of mail fraud in violation of 18 U.S.C. § 1341, and multiple instances of wire fraud in violation of 18 U.S.C. § 1343. The PBMs knowingly made material misstatements to health care payers, plan members, and the general public in furtherance of the fraudulent scheme regarding:
a. The actual price of Lantus;
b. The extent to which the actual price of Lantus departed from the published, artificially-inflated benchmark price;
c. The extent to which Sanofi and the PBMs had negotiated the rebates discounting the benchmark price of Lantus in good faith and for a proper purpose;
d. Whether the rebates were intended to benefit health care payers, plan members, and/or the general public;
e. Whether the rebates saved health care payers, plan members, and the general public money;
f. Whether Lantus’ “preferred” formulary status reflected the drug’s safety, efficacy, or cost-effectiveness, as determined by the PBMs’ P&T Committees;
g. Whether Lantus would have been placed in a “preferred” formulary position absent the rebates; and
h. The extent to which the rebating scheme would force plan members to incur additional expenses for their Lantus prescriptions.
178. Sanofi alone could not have accomplished the purpose of the Lantus Pricing Enterprise, without the assistance of the PBMs. For Sanofi to profit from the scheme, the PBMs needed to convince health care payers and plan sponsors to select their formulary, on which Lantus was given favorable treatment. And the PBMs did so through misrepresentations: they told clients, potential clients, and investors that they secured significant discounts. However, these discounts were only significant because the benchmark prices were artificially inflated. The discounts were fictitious: the result of a deliberate scheme to create large rebates without lowering real prices. Without these misrepresentations, the Lantus Pricing Enterprise could not have achieved its common purpose.
179. The Lantus Pricing Enterprise engaged in and affected interstate commerce because, inter alia, it set the price of drugs that were sold to and utilized by thousands of class members throughout the United States, its territories, the District of Columbia, and the Commonwealth of Puerto Rico.
180. The impacts of the Lantus Pricing Enterprise’s scheme are still in place—i.e., the increased spread between the Lantus benchmark price and the actual price of Lantus is still being maintained, and increased. Consequently, PBMs and pharmacies make a profit on the spread between benchmark price and the actual acquisition cost—i.e., the rebates. Under this system, a higher spread results in increased profits to PBMs and pharmacies.
181. The foregoing evidenced that Sanofi, CVS Caremark, Express Scripts, and OptumRx were each willing participants in the Lantus Pricing Enterprise, had a common purpose and interest in the object of the scheme, and functioned within a structure designed to effectuate the Enterprise’s purpose, i.e., through Sanofi’s artificial inflation of the Lantus benchmark price, coupled with Sanofi’s and the PBMs’ creation of substantial rebates, and the PBMs’ misstatements to the drug-purchasing public that those rebates benefitted health care payer and consumers like Plaintiffs and the class.
B. Conduct of the Lantus Pricing Enterprise
182. During the class period, Sanofi exerted control over the Lantus Pricing Enterprise and participated in the operation or management of the affairs of the Lantus Pricing Enterprise, directly or indirectly, in the following ways:
a. Sanofi selected and published the Lantus benchmark price;
b. Sanofi periodically raised the published Lantus benchmark price;67
c. Sanofi granted to the PBMs substantial rebates representing discounts off of the Lantus benchmark price in exchange for the PBMs’ promise to give Lantus exclusive or at least favorable, formulary placement;
d. Sanofi concealed from the public the amount and purpose of the rebates;
e. Sanofi intended that the PBMs would (and did) distribute through the U.S. Mail and interstate wire facilities, promotional and other materials which claimed that rebates (such as those applied to Lantus) saved health care payers and consumers like Plaintiffs and class members money on their prescription needs; and
f. The public, through stating of Lantus’ benchmark price without stating that the benchmark price differed substantially from that negotiated by PBMs, that the Lantus benchmark price reflected or approximated Lantus’ actual cost.
183. The scheme had a hierarchical decision-making structure that was headed by Sanofi. Sanofi controlled the Lantus benchmark price, and doled out rebates to the PBMs in exchange for the PBMs’ assurances that Lantus would receive exclusive, or at least favorable, formulary placement.
184. The PBMs also participated in the conduct of the affairs of the Lantus Pricing Enterprise, directly or indirectly, in the following ways:
a. The PBMs promised to, and did, confer on Lantus exclusive or at least favorable formulary placement;
b. The PBMs distribute through the U.S. Mail and interstate wire facilities, promotional and other materials which claimed that rebates (such as those applied to Lantus) saved health care payers and consumers like Plaintiffs and class members money on their prescription needs; and
c. The PBMs concealed the existence or amount of the rebates—including those given to their competitors—to further the fraudulent pricing scheme.
185. The scheme devised and implemented by Sanofi, as well as other members of the Lantus Pricing Enterprise, amounted to a common course of conduct intended to (a) secure favorable formulary positioning for Lantus; (b) entice health care payers to select one of the PBMs’ formularies; and thereby (c) secure payment for prescriptions of Lantus written by plan members’ physicians.
C. Sanofi’s Pattern of Racketeering Activity
186. Sanofi conducted and participated in the conduct of the affairs of the Lantus Pricing Enterprise through a pattern of racketeering activity, including acts that are indictable under 18 U.S.C. § 1341, relating to mail fraud, and 18 U.S.C. § 1343, relating to wire fraud. The pattern of racketeering activity by the Lantus Pricing Enterprise likely involved thousands of separate instances of use of the U.S. Mail or interstate wire facilities in furtherance of the unlawful Lantus pricing scheme. Each of these fraudulent mailings and interstate wire transmissions constitutes “racketeering activity” within the meaning of 18 U.S.C. § 1961(1)(B). Collectively, these violations constitute a “pattern of racketeering activity,” within the meaning of 18 U.S.C. § 1961(5), through which Sanofi and the PBMs intended to defraud Plaintiffs, members of the class, and other intended victims.
187. Each instance of racketeering activity alleged herein was related, had similar purposes, involved the same or similar participants and methods of commission, and had similar results affecting similar victims, including Plaintiffs and members of the class. Sanofi and the PBMs calculated and intentionally crafted the Lantus pricing scheme to ensure their own profits remained high, without regard to the effect such pricing behavior had on Plaintiffs and members of the class who would be over-billed for Lantus. In designing and implementing the scheme, at all times Sanofi was cognizant of the fact that those in the distribution chain who are not part of the industry rely on the integrity of the pharmaceutical companies and PBMs in setting benchmark prices and establishing rebates.
188. By intentionally and artificially inflating the Lantus benchmark price, and then subsequently failing to disclose such practices to the individual patients, health plans, and insurers, Sanofi and the PBMs engaged in a fraudulent and unlawful course of conduct constituting a pattern of racketeering activity.
189. Sanofi’s and the PBMs’ racketeering activities amounted to a common course of conduct, with a similar pattern and purpose, intended to deceive Plaintiffs and members of the class. Each separate use of the U.S. Mail and/or interstate wire facilities employed by Sanofi was related, had similar intended purposes, involved similar participants and methods of execution, and had the same results affecting the same victims, including Plaintiffs and members of the class. Sanofi has engaged in the pattern of racketeering activity for the purpose of conducting the ongoing business affairs of its Lantus Pricing Enterprise.
190. The pattern of racketeering activity alleged herein and the Lantus Pricing Enterprise are separate and distinct from each other. Likewise, Sanofi is distinct from the Lantus Pricing Enterprise.
191. The pattern of racketeering activity alleged herein is continuing as of the date of this complaint, and, upon information and belief, will continue into the future unless enjoined by this Court.
D. Sanofi’s Use of the U.S. Mail and Interstate Wire Facilities
192. The Lantus Pricing Enterprise engaged in and affected interstate commerce because it engaged in the following activities across state boundaries: the transmission and publication of false and misleading information concerning the Lantus benchmark price; the payment from Sanofi to the PBMs of substantial rebates off of the benchmark price; and transmission of false or incomplete statements intended to mislead health care payers and consumers regarding the existence, amount, and purpose of the rebates.
193. During the class period, the Lantus Pricing Enterprise’s unlawful conduct and wrongful practices were carried out by an array of employees, working across state boundaries, who necessarily relied upon frequent transfers of documents, information, products, and funds by the U.S. Mail and interstate wire facilities.
194. The nature and pervasiveness of the Lantus pricing fraud scheme, which was orchestrated out of the corporate headquarters of Sanofi and each PBM, necessarily required those headquarters to communicate directly and frequently by U.S. Mail and interstate wire facilities.
195. Many of the precise dates of the Lantus Pricing Enterprise’s uses of the U.S. Mail and interstate wire facilities (and corresponding RICO predicate acts of mail and wire fraud) have been hidden and cannot be alleged without access to Sanofi’s, CVS Caremark’s, Express Scripts’s, and OptumRx’s books and records. Indeed, an essential part of the successful operation of the Lantus Pricing Enterprise alleged herein depended upon secrecy. However, Plaintiffs can generally describe the occasions on which the RICO predicate acts of mail fraud and wire fraud occurred, and how those acts were in furtherance of the scheme; Plaintiffs describe this below.
196. Sanofi’s use of the U.S. Mail and interstate wire facilities to perpetrate the Lantus pricing fraud scheme involved thousands of communications throughout the class period including, inter alia:
a. Marketing materials about Sanofi’s Lantus product and its price, which Sanofi sent to health care payers and health care providers located across the country;
b. Written communications between Sanofi and the publishers of benchmark price compendia regarding the Lantus benchmark price and its subsequent mark-ups, which occurred on a regular basis each year;
c. Written representations and telephone calls between Sanofi and CVS Caremark regarding Lantus markups and benchmark price;
d. Written representations and telephone calls between Sanofi and Express Scripts regarding Lantus markups and benchmark price;
e. Written representations and telephone calls between Sanofi and OptumRx regarding Lantus markups and benchmark price;
f. Written representations and telephone calls between Sanofi and CVS Caremark regarding Lantus rebates;
g. Written representations and telephone calls between Sanofi and Express Scripts regarding Lantus rebates;
h. Written representations and telephone calls between Sanofi and OptumRx regarding Lantus rebates;
i. Hundreds of e-mails between Sanofi and the PBMs agreeing to or effectuating the implementation of the Lantus pricing fraud scheme;
j. Written and oral communications directed to U.S. Government agencies and private insurers that fraudulently misrepresented what the Lantus benchmark price was; the existence, amount, or purpose of the Lantus rebates; and the true cost of Lantus that were designed to conceal the scheme, deter investigations into Lantus pricing, or forestall changes to healthcare payers reimbursement of Lantus prescriptions based on something other than the Lantus benchmark price; and
k. Receipts of increased profits sent through the U.S. Mail and interstate wire facilities—the wrongful proceeds of the scheme.
197. In addition to the above-referenced RICO predicate acts, it was foreseeable to Sanofi that the PBMs would distribute publications through the U.S. Mail and by interstate wire facilities, and in those publications, claim that the increased rebates would benefit third-party payors and consumers like Plaintiffs and class members.
The Federal Class Action lawsuit against Sanofi, Novo Nordisk and Eli Lilly was filed on 1/30/2017 on charges of colluding in insulin price fixing, among other things. The web of corruption that runs among these three companies is an intricate one.
This thread is dedicated to the discussion on the Class Action filed against Sanofi, Novo Nordisk and Eli Lilly.
This filing contains an incredible, insightful view into the inner-workings of the racketeering played out by Sanofi, Novo Nordisk and Eli Lilly. This is only 169 pages, but I have only read the Introduction and this particular RICO section so far. All I can say is WOW, they are F_ _ _ ed! The evidence is overwhelming just in this section alone. What a grand and complex scheme these injectable insulin cartels have orchestrated. I would without a doubt say the 2017 Type 2 Diabetes Consensus Statement was orchestrated with corruption. Sanofi, Novo Nordisk and Eli Lilly's names are all over the disclosures, frightening actually the prevalence is.
Below is the Class Action plaintiffs and defendants, along with the particular Sanofi RICO section that I read and wanted to share. The other two companies' RICO sections follow Sanofi's if you wish to click the link and read more.
If you skim read or skip through it you will most certainly not get the details. This is worth the effort and time because this is extremely important.
LINK TO THE FILING:
cdn1.nyt.com/science/01-30-17_Insulin_Class_Action_Complaint_Hagens_Berman.PDF
Case 1:17-cv-10158 Document 1 Filed 01/30/17 Page 1 of 169
UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS
DONALD CHAIRES, GEORGE DENAULT, JANE DOE, JOHN DOE, BRITTANY GILLELAND, GERALD GIRARD, SARA HASSELBACH, LINDSEY KINHAN, JOSEPH MCLAUGHLIN, MATTHEW TEACHMAN, and KARYN WOFFORD,
Plaintiffs,
v.
SANOFI U.S., NOVO NORDISK INC., and ELI LILLY AND COMPANY,
Defendants.
No. 1:17-cv-10158
DEMAND FOR JURY TRIAL
CLASS ACTION COMPLAINT
VIII. CLAIMS FOR RELIEF
COUNT ONE
VIOLATION OF THE RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS ACT (“RICO”), 18 U.S.C. § 1961, ET SEQ.
164. Plaintiffs Chaires, Jane Doe, Gilleland, Girard, Hasselbach, McLaughlin, and Wofford hereby incorporate by reference the allegations contained in the preceding paragraphs of this complaint.
165. This claim is brought on behalf of the class against Sanofi for actual damages, treble damages, and equitable relief under 18 U.S.C. § 1964 for violations of 18 U.S.C. § 1962, et seq.
166. Defendant is a “person” within the meaning of 18 U.S.C. § 1961(3) who conducted the affairs of an enterprise through a pattern of racketeering activity, in violation of 18 U.S.C. § 1962(c).
167. Plaintiffs and the members of the class are each “persons,” as that term is defined in 18 U.S.C. § 1961(3) who were injured in their business or property as a result of Sanofi’s wrongful conduct.
A. The Lantus Pricing Enterprise
168. Under 18 U.S.C. § 1961(4) a RICO “enterprise” may be an association-in-fact that, although it has no formal legal structure, has (i) a common purpose, (ii) relationships among those associated with the enterprise, and (iii) longevity sufficient to pursue the enterprise’s purpose.
169. Sanofi formed just such an
association-in-fact enterprise—sometimes referred to in this complaint as the Lantus Pricing Enterprise.
The Lantus Pricing Enterprise consists of
(a) Sanofi, including its employees and agents;
(b) the PBM CVS Caremark, including its employees and agents;
(c) the PBM Express Scripts, including its employees and agents; and
(d) the PBM OptumRx, including its employees and agents.
170. The Lantus Pricing Enterprise is an ongoing and continuing business organization consisting of “persons” within the meaning of 18 U.S.C. § 1961(3) that created and maintained systematic links for a common purpose: to secure an exclusive, or at least favorable, formulary position for Sanofi’s long-acting analog insulin product, Lantus, as a treatment for type 1 and 2 diabetes to the exclusion or detriment of competitor products and consumers.
171. To accomplish this purpose, the Lantus Pricing Enterprise periodically and systematically inflated the benchmark price of Lantus and represented—either affirmatively or through half-truths and omissions—to the general public, health care payers, and consumers, including Plaintiffs and the class, that Lantus’ benchmark price fairly and accurately reflected the actual cost of this drug. The Lantus Pricing Enterprise concealed from the public, health care payers, and consumers, like Plaintiffs and the class members, the existence and amount of steep rebates Sanofi gave to the PBMs. These rebates were worth at least 25% of the benchmark price. The Lantus Pricing Enterprise also concealed from the public the purpose of these rebates: The difference between the benchmark price and the real price of Lantus negotiated by the PBMs resulted in increased profits for the PBMs. These large rebates served to ensure that the PBMs would place, and maintain, Lantus in a preferred or favorable position on the PBMs’ formularies. By securing a favorable position on the formulary, the Lantus Pricing Enterprise ensured that a larger number of Lantus prescriptions would be written and filled. This scheme translated into higher sales (and therefore profits) for Sanofi and larger spreads for the PBMs.
172. The persons engaged in the Lantus Pricing Enterprise are systematically linked through contractual relationships, financial ties, and continuing coordination of activities, as spearheaded by Sanofi. There is regular communication between Sanofi and each of the PBMs, in which information is shared. Typically, this communication occurred, and continues to occur, through the use of the wires and the mail in which Sanofi and the PBMs share information regarding the Lantus benchmark price and discuss and agree on rebate amounts. Sanofi and the PBMs functioned as a continuing unit for the purposes of implementing the Lantus pricing scheme and, when issues arise during the scheme, each agreed to take actions to hide the scheme and continue its existence.
173. At all relevant times, CVS Caremark was aware of Sanofi’s conduct, was a knowing and willing participant in that conduct, and reaped profits from that conduct. CVS Caremark struck rebate deals with Sanofi to conceal the true price of Lantus and profit from the inflated rebates. CVS Caremark represented to the public that the rebates it negotiated saved health care payers and their plan members (including Plaintiffs and members of the class) money on their prescription needs. But it knew that the rebates did not actually decrease the cost of Lantus for consumers, because the published benchmark price was falsely inflated. CVS Caremark also knew, but did not disclose, that the other PBMs—Express Scripts and OptumRx—were engaged in the same rebating scheme, to the detriment of consumers. But for the Lantus Pricing Enterprise’s unlawful fraud, CVS Caremark would have had the incentive to disclose the deceit by Sanofi, thereby forcing competition on real price. By failing to disclose this information, CVS Caremark perpetuated the Lantus Pricing Enterprise’s scheme, and reaped substantial profits.
174. At all relevant times, Express Scripts was aware of Sanofi’s conduct, was a knowing and willing participant in that conduct, and reaped profits from that conduct. Express Scripts struck rebate deals with Sanofi to conceal the true price of Lantus and profit from the inflated rebates. Express Scripts represented to the public that the rebates it negotiated saved health care payers and their plan members (including Plaintiffs and members of the class) money on their prescription needs. But it knew that the rebates did not actually decrease the cost of Lantus for consumers, because the published benchmark price was falsely inflated. Express Scripts also knew, but did not disclose, that the other PBMs—CVS Caremark and OptumRx— were engaged in the same rebating scheme, to the detriment of consumers. But for the Lantus Pricing Enterprise’s unlawful fraud, Express Scripts would have been incentivized to disclose the deceit by its competitors, thereby obtaining a competitive advantage. By failing to disclose this information, Express Scripts perpetuated the Lantus Pricing Enterprise’s scheme, and reaped substantial profits.
175. At all relevant times, OptumRx was aware of Sanofi’s conduct, was a knowing and willing participant in that conduct, and reaped profits from that conduct. OptumRx struck rebate deals with Sanofi to conceal the true price of Lantus and profit from the inflated rebates. OptumRx represented to the public that the rebates it negotiated saved health care payers and their plan members (including Plaintiffs and members of the class) money on their prescription needs. But it knew that the rebates did not actually decrease the cost of Lantus for consumers, because the published benchmark price was falsely inflated. OptumRx also knew, but did not disclose, that the other PBMs—CVS Caremark and Express Scripts—were engaged in the same rebating scheme, to the detriment of consumers. But for the Lantus Pricing Enterprise’s unlawful fraud, OptumRx would have been incentivized to disclose the deceit by its competitors, thereby obtaining a competitive advantage. By failing to disclose this information, OptumRx perpetuated the Lantus Pricing Enterprise’s scheme, and reaped substantial profits.
176. Furthermore, as public scrutiny, media coverage, and congressional investigations have focused on the rapidly-inflating prices of lifesaving drugs—including insulin—the PBMs did not challenge Sanofi’s reported benchmark prices, terminate their role in the Lantus Pricing Enterprise, nor disclose publicly that the Lantus benchmark price did not accurately reflect the price actually paid for the drug.
177. CVS Caremark, Express Scripts, and OptumRx participated in the conduct of the Lantus Pricing Enterprise, sharing the common purpose of securing exclusive or favorable formulary position for Lantus, through a pattern of racketeering activity within the meaning of 18 U.S.C. §§ 1961(1) and (5), which includes multiple instances of mail fraud in violation of 18 U.S.C. § 1341, and multiple instances of wire fraud in violation of 18 U.S.C. § 1343. The PBMs knowingly made material misstatements to health care payers, plan members, and the general public in furtherance of the fraudulent scheme regarding:
a. The actual price of Lantus;
b. The extent to which the actual price of Lantus departed from the published, artificially-inflated benchmark price;
c. The extent to which Sanofi and the PBMs had negotiated the rebates discounting the benchmark price of Lantus in good faith and for a proper purpose;
d. Whether the rebates were intended to benefit health care payers, plan members, and/or the general public;
e. Whether the rebates saved health care payers, plan members, and the general public money;
f. Whether Lantus’ “preferred” formulary status reflected the drug’s safety, efficacy, or cost-effectiveness, as determined by the PBMs’ P&T Committees;
g. Whether Lantus would have been placed in a “preferred” formulary position absent the rebates; and
h. The extent to which the rebating scheme would force plan members to incur additional expenses for their Lantus prescriptions.
178. Sanofi alone could not have accomplished the purpose of the Lantus Pricing Enterprise, without the assistance of the PBMs. For Sanofi to profit from the scheme, the PBMs needed to convince health care payers and plan sponsors to select their formulary, on which Lantus was given favorable treatment. And the PBMs did so through misrepresentations: they told clients, potential clients, and investors that they secured significant discounts. However, these discounts were only significant because the benchmark prices were artificially inflated. The discounts were fictitious: the result of a deliberate scheme to create large rebates without lowering real prices. Without these misrepresentations, the Lantus Pricing Enterprise could not have achieved its common purpose.
179. The Lantus Pricing Enterprise engaged in and affected interstate commerce because, inter alia, it set the price of drugs that were sold to and utilized by thousands of class members throughout the United States, its territories, the District of Columbia, and the Commonwealth of Puerto Rico.
180. The impacts of the Lantus Pricing Enterprise’s scheme are still in place—i.e., the increased spread between the Lantus benchmark price and the actual price of Lantus is still being maintained, and increased. Consequently, PBMs and pharmacies make a profit on the spread between benchmark price and the actual acquisition cost—i.e., the rebates. Under this system, a higher spread results in increased profits to PBMs and pharmacies.
181. The foregoing evidenced that Sanofi, CVS Caremark, Express Scripts, and OptumRx were each willing participants in the Lantus Pricing Enterprise, had a common purpose and interest in the object of the scheme, and functioned within a structure designed to effectuate the Enterprise’s purpose, i.e., through Sanofi’s artificial inflation of the Lantus benchmark price, coupled with Sanofi’s and the PBMs’ creation of substantial rebates, and the PBMs’ misstatements to the drug-purchasing public that those rebates benefitted health care payer and consumers like Plaintiffs and the class.
B. Conduct of the Lantus Pricing Enterprise
182. During the class period, Sanofi exerted control over the Lantus Pricing Enterprise and participated in the operation or management of the affairs of the Lantus Pricing Enterprise, directly or indirectly, in the following ways:
a. Sanofi selected and published the Lantus benchmark price;
b. Sanofi periodically raised the published Lantus benchmark price;67
c. Sanofi granted to the PBMs substantial rebates representing discounts off of the Lantus benchmark price in exchange for the PBMs’ promise to give Lantus exclusive or at least favorable, formulary placement;
d. Sanofi concealed from the public the amount and purpose of the rebates;
e. Sanofi intended that the PBMs would (and did) distribute through the U.S. Mail and interstate wire facilities, promotional and other materials which claimed that rebates (such as those applied to Lantus) saved health care payers and consumers like Plaintiffs and class members money on their prescription needs; and
f. The public, through stating of Lantus’ benchmark price without stating that the benchmark price differed substantially from that negotiated by PBMs, that the Lantus benchmark price reflected or approximated Lantus’ actual cost.
183. The scheme had a hierarchical decision-making structure that was headed by Sanofi. Sanofi controlled the Lantus benchmark price, and doled out rebates to the PBMs in exchange for the PBMs’ assurances that Lantus would receive exclusive, or at least favorable, formulary placement.
184. The PBMs also participated in the conduct of the affairs of the Lantus Pricing Enterprise, directly or indirectly, in the following ways:
a. The PBMs promised to, and did, confer on Lantus exclusive or at least favorable formulary placement;
b. The PBMs distribute through the U.S. Mail and interstate wire facilities, promotional and other materials which claimed that rebates (such as those applied to Lantus) saved health care payers and consumers like Plaintiffs and class members money on their prescription needs; and
c. The PBMs concealed the existence or amount of the rebates—including those given to their competitors—to further the fraudulent pricing scheme.
185. The scheme devised and implemented by Sanofi, as well as other members of the Lantus Pricing Enterprise, amounted to a common course of conduct intended to (a) secure favorable formulary positioning for Lantus; (b) entice health care payers to select one of the PBMs’ formularies; and thereby (c) secure payment for prescriptions of Lantus written by plan members’ physicians.
C. Sanofi’s Pattern of Racketeering Activity
186. Sanofi conducted and participated in the conduct of the affairs of the Lantus Pricing Enterprise through a pattern of racketeering activity, including acts that are indictable under 18 U.S.C. § 1341, relating to mail fraud, and 18 U.S.C. § 1343, relating to wire fraud. The pattern of racketeering activity by the Lantus Pricing Enterprise likely involved thousands of separate instances of use of the U.S. Mail or interstate wire facilities in furtherance of the unlawful Lantus pricing scheme. Each of these fraudulent mailings and interstate wire transmissions constitutes “racketeering activity” within the meaning of 18 U.S.C. § 1961(1)(B). Collectively, these violations constitute a “pattern of racketeering activity,” within the meaning of 18 U.S.C. § 1961(5), through which Sanofi and the PBMs intended to defraud Plaintiffs, members of the class, and other intended victims.
187. Each instance of racketeering activity alleged herein was related, had similar purposes, involved the same or similar participants and methods of commission, and had similar results affecting similar victims, including Plaintiffs and members of the class. Sanofi and the PBMs calculated and intentionally crafted the Lantus pricing scheme to ensure their own profits remained high, without regard to the effect such pricing behavior had on Plaintiffs and members of the class who would be over-billed for Lantus. In designing and implementing the scheme, at all times Sanofi was cognizant of the fact that those in the distribution chain who are not part of the industry rely on the integrity of the pharmaceutical companies and PBMs in setting benchmark prices and establishing rebates.
188. By intentionally and artificially inflating the Lantus benchmark price, and then subsequently failing to disclose such practices to the individual patients, health plans, and insurers, Sanofi and the PBMs engaged in a fraudulent and unlawful course of conduct constituting a pattern of racketeering activity.
189. Sanofi’s and the PBMs’ racketeering activities amounted to a common course of conduct, with a similar pattern and purpose, intended to deceive Plaintiffs and members of the class. Each separate use of the U.S. Mail and/or interstate wire facilities employed by Sanofi was related, had similar intended purposes, involved similar participants and methods of execution, and had the same results affecting the same victims, including Plaintiffs and members of the class. Sanofi has engaged in the pattern of racketeering activity for the purpose of conducting the ongoing business affairs of its Lantus Pricing Enterprise.
190. The pattern of racketeering activity alleged herein and the Lantus Pricing Enterprise are separate and distinct from each other. Likewise, Sanofi is distinct from the Lantus Pricing Enterprise.
191. The pattern of racketeering activity alleged herein is continuing as of the date of this complaint, and, upon information and belief, will continue into the future unless enjoined by this Court.
D. Sanofi’s Use of the U.S. Mail and Interstate Wire Facilities
192. The Lantus Pricing Enterprise engaged in and affected interstate commerce because it engaged in the following activities across state boundaries: the transmission and publication of false and misleading information concerning the Lantus benchmark price; the payment from Sanofi to the PBMs of substantial rebates off of the benchmark price; and transmission of false or incomplete statements intended to mislead health care payers and consumers regarding the existence, amount, and purpose of the rebates.
193. During the class period, the Lantus Pricing Enterprise’s unlawful conduct and wrongful practices were carried out by an array of employees, working across state boundaries, who necessarily relied upon frequent transfers of documents, information, products, and funds by the U.S. Mail and interstate wire facilities.
194. The nature and pervasiveness of the Lantus pricing fraud scheme, which was orchestrated out of the corporate headquarters of Sanofi and each PBM, necessarily required those headquarters to communicate directly and frequently by U.S. Mail and interstate wire facilities.
195. Many of the precise dates of the Lantus Pricing Enterprise’s uses of the U.S. Mail and interstate wire facilities (and corresponding RICO predicate acts of mail and wire fraud) have been hidden and cannot be alleged without access to Sanofi’s, CVS Caremark’s, Express Scripts’s, and OptumRx’s books and records. Indeed, an essential part of the successful operation of the Lantus Pricing Enterprise alleged herein depended upon secrecy. However, Plaintiffs can generally describe the occasions on which the RICO predicate acts of mail fraud and wire fraud occurred, and how those acts were in furtherance of the scheme; Plaintiffs describe this below.
196. Sanofi’s use of the U.S. Mail and interstate wire facilities to perpetrate the Lantus pricing fraud scheme involved thousands of communications throughout the class period including, inter alia:
a. Marketing materials about Sanofi’s Lantus product and its price, which Sanofi sent to health care payers and health care providers located across the country;
b. Written communications between Sanofi and the publishers of benchmark price compendia regarding the Lantus benchmark price and its subsequent mark-ups, which occurred on a regular basis each year;
c. Written representations and telephone calls between Sanofi and CVS Caremark regarding Lantus markups and benchmark price;
d. Written representations and telephone calls between Sanofi and Express Scripts regarding Lantus markups and benchmark price;
e. Written representations and telephone calls between Sanofi and OptumRx regarding Lantus markups and benchmark price;
f. Written representations and telephone calls between Sanofi and CVS Caremark regarding Lantus rebates;
g. Written representations and telephone calls between Sanofi and Express Scripts regarding Lantus rebates;
h. Written representations and telephone calls between Sanofi and OptumRx regarding Lantus rebates;
i. Hundreds of e-mails between Sanofi and the PBMs agreeing to or effectuating the implementation of the Lantus pricing fraud scheme;
j. Written and oral communications directed to U.S. Government agencies and private insurers that fraudulently misrepresented what the Lantus benchmark price was; the existence, amount, or purpose of the Lantus rebates; and the true cost of Lantus that were designed to conceal the scheme, deter investigations into Lantus pricing, or forestall changes to healthcare payers reimbursement of Lantus prescriptions based on something other than the Lantus benchmark price; and
k. Receipts of increased profits sent through the U.S. Mail and interstate wire facilities—the wrongful proceeds of the scheme.
197. In addition to the above-referenced RICO predicate acts, it was foreseeable to Sanofi that the PBMs would distribute publications through the U.S. Mail and by interstate wire facilities, and in those publications, claim that the increased rebates would benefit third-party payors and consumers like Plaintiffs and class members.