United States ex rel. Gohil v. Sanofi U.S. Servs. Inc.
| Decision Date | 12 November 2020 |
| Docket Number | CIVIL ACTION No. 02-2964 |
| Citation | 500 F.Supp.3d 345 |
| Parties | UNITED STATES EX REL. Yoash GOHIL, Plaintiff/Relator. v. SANOFI U.S. SERVICES INC. et al., Defendants. |
| Court | U.S. District Court — Eastern District of Pennsylvania |
Carl D. Poplar, Cherry Hill, NJ, Alan M. Freeman, Blank Rome LLP, Washington, DC, Blair A. Gerold, Jaret N. Gronczewski, Jeremy Kolman, Nicholas Carl Harbist, Stephanie C. Chomentowski, Stephen M. Orlofsky, William R. Cruse, Blank Rome LLP, Joel M. Sweet, U.S. Attorney's Office, Naomi Zwillenberg, Philadelphia, PA, for Plaintiff/Relator.
Patrick L. Oot, Jr., Shook Hardy & Bacon LLP, Washington, DC, Robert J. McCully, Shook Hardy & Bacon LLP, Kansas City, MO, Carrie Sarhangi Love, Richard L. Scheff, Armstrong Teasdale LLP, Philadelphia, PA, Jennifer L. Herbst, Quinnipiac Univ Sch of Law, Hamden, CT, for Defendant Aventis, Inc.
Patrick L. Oot, Jr., Shook Hardy & Bacon LLP, Washington, DC, Richard L. Scheff, Carrie Sarhangi Love, Armstrong Teasdale, LLP, Philadelphia, PA, Robert J. McCully, Shook Hardy & Bacon LLP, Kansas City, MO, Jennifer L. Herbst, Quinnipiac Univ Sch of Law, Hamden, CT, for Defendants Sanofi US Services Inc., Aventisub LLC.
I. INTRODUCTION ... 352
II. BACKGROUND ... 353
III. STANDARD OF REVIEW ... 356
IV. THE LAW ... 357
V. THE INDIVIDUAL SCHEMES ... 362
VI. CONCLUSION ... 379
I. INTRODUCTION
This memorandum addresses Act Two of the two-act motions for summary judgment.
Plaintiff-Relator Yoash Gohil brings this lawsuit against his former employer, the pharmaceutical company Aventis.1 Gohil contends that Aventis violated the False Claims Act ("FCA"). He claims that from 1996 to 2004, Aventis engaged in a nationwide marketing scheme involving a variety of kickbacks that induced doctors to prescribe the cancer drug Taxotere —prescriptions which the doctors then asked the government to reimburse.2
In Act One of the summary judgment motions, which I addressed on March 4, 2020, I denied cross-motions for summary judgment that specifically addressed Gohil's claims that Aventis's so-called reimbursement-assistance program—the "Providing Access to Cancer Therapy Program" or "PACT Program"—violated the FCA. See Order, Mar. 4, 2020, ECF No. 373; Mem., July 21, 2020, ECF No. 415 ("PACT Summ. J. Mem."). On April 20, 2020, in Act Two of the summary judgment motions, Aventis filed a summary judgment motion on the remaining schemes.3 The remaining schemes are:
This memorandum will address Act Two of the motions for summary judgment.
I will deny the motion as to the Advisory Boards, Speaker Programs, and Education Grants schemes. I will grant the motion as to the Preceptorships scheme. As for the Ad Hoc Kickbacks Scheme, I will deny the motion for the provision of meals and gift baskets, and I will grant the motion as to the remaining alleged ad hoc kickbacks.
II. BACKGROUND 4
Aventis's cancer drug, Taxotere, was first approved by the FDA in 1996. When it entered the market that year, Taxotere faced competitive disadvantages. Compared to its main competitor—a similar cancer drug called Taxol—Taxotere was more expensive and had been approved by the FDA for fewer specific uses. According to Gohil, Aventis aimed to overcome these disadvantages by pursuing an aggressive Taxotere marketing scheme from 1996 to 2004. As part of this marketing plan, Gohil contends that Aventis engaged in a number of kickback schemes to induce doctors to prescribe Taxotere instead of Taxol. I will describe each of the alleged schemes.
On paper, Aventis implemented advisory boards to "create an intimate forum where oncology issues, clinical data, and patient care [could] be debated." Relator Ex. 53, at 19. In a presentation entitled "Maximizing Taxotere Growth," Vice President of Oncology Mark Alles described Aventis's advisory boards:
Medical oncologists will be brought together to discuss issues important to their particular local area. There will be presentations from invited speakers. Participants will have the opportunity to comment on future clinical development plans, and existing data on Taxotere. Participants will also be asked their opinion on some marketing strategies.
Id. Aventis's internal compliance policies stated that advisory board attendees were to be chosen based on their qualifications—not their volume of business or favorable opinion of Taxotere —and compensated at fair market value. Aventis Ex. 54, at 2-3 ("Aventis 1997 Policies").
In practice, however, Aventis used advisory boards as a "sales tactic[ ]" to "expand Taxotere's market presence." Relator Ex. 41 pt. 2, at 1-2; Relator Ex. 44, at 334:22-335:9 ("Corrigan Dep. I"). Aventis paid doctors to attend advisory boards in desirable locations and offered valuable entertainment. Attendees received honoraria (around $1000) and all-expenses paid trips to locations like Rome and New York City. Relator Ex. 108; Relator Ex. 109. Aventis also organized entertainment for attendees, including golf outings and Broadway shows. Relator Ex. 24, at 191:2-22 ("Corrigan Dep. II"); Relator Ex. 109. To participate, attendees at advisory boards were required to sign acknowledgements that "these payments constitute[d] fair market value and [had] not been determined in a manner that [took] into account the volume or value of any referrals generated between the parties." Aventis 1997 Policies, at 50; Relator Ex. 108, at 3. But a spot check in 2004 revealed that Aventis only had signed agreements on file for two of the nine advisory board attendees audited. Relator Ex. 42 pt. 1, at 10.
Aventis invited "targeted physicians" from "key accounts" to attend advisory boards. Relator Ex. 41 pt. 2, at 2. For example, Vice President of Oncology Mark Alles applauded the invitation of a particular doctor to an advisory board: Relator Ex. 64. Additionally, regional managers were advised to screen invitations to exclude "[p]hysicians who have strong potential to be antagonistic." Relator Ex. 58, at 4.
Furthermore, Aventis controlled the content of advisory boards. To assure doctors that they would "not be the first oncologist or lone wolf" to use Taxotere off-label, Aventis paid chosen doctors—or "thought leaders"—to deliver presentations about the benefits of off-label use. Corrigan Dep. II, at 187:5-21; Relator Ex. 58, at 3. Aventis ensured that "[e]ach speaker's slides were carefully reviewed prior to the meeting to make sure they covered all relevant topics." Relator Ex. 41 pt. 2, at 2. Senior Product Manager Gregg Bernier instructed regional directors and managers to further "maintain control" by eliminating Q & A and by "identify[ing] ‘aces’ in the audience" who could "shut-down the physicians who are being difficult." Relator Ex. 58, at 3. He explained: Id. at 3-4.
On paper, Aventis set up what it characterized as speaker programs. In his "Maximizing Taxotere Growth" presentation, Vice President of Oncology Mark Alles described Aventis's "speakers bureau":
A vendor maintains a registry of 300–500 national and regionally recognized experts in the field of Medical Oncology .... Physicians are trained on the latest Taxotere data during a 1–2 day seminar given 4 times each year. Updated information and slides are automatically forwarded to speakers under contract with [Aventis].
Relator Ex. 53, at 23. Aventis's internal compliance policies stated that speaker arrangements could not be based on the speaker's volume of business or favorable opinion of Taxotere and also required speakers to be compensated at fair market value. Aventis 1997 Policies, at 2-3.
In practice, Aventis targeted doctors from "key" accounts because "developing [doctors] as speakers and advocates had a positive impact on sales in the surrounding community territories." Relator Ex. 41 pt. 1, at 4, 11. As one regional manager explained: Id. at 11.
Aventis provided all-expenses paid trips, desirable entertainment, and honoraria to these select doctors. For 1999, Aventis budgeted $1.2 million for the speakers bureau and an additional $2 million for speaker training. Relator Ex. 53, at 23, 26. Using this budget, Aventis paid doctors to attend speaker "training" and "development" workshops in locations like Las...
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