In Re Actiq Sales and Marketing Practices Litig.

790 F. Supp. 2d 313
CourtDistrict Court, E.D. Pennsylvania
DecidedMarch 23, 2011
DocketCivil Action Nos. 07-4492, 09-431
StatusPublished
Cited by14 cases

This text of 790 F. Supp. 2d 313 (In Re Actiq Sales and Marketing Practices Litig.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Actiq Sales and Marketing Practices Litig., 790 F. Supp. 2d 313 (E.D. Pa. 2011).

Opinion

790 F.Supp.2d 313 (2011)

In re ACTIQ SALES AND MARKETING PRACTICES LITIGATION.
American Federation of State, County and Municipal Employees, District Council 47 Health and Welfare Fund, et al., Plaintiffs,
v.
Cephalon, Inc., Defendant.

Civil Action Nos. 07-4492, 09-431.

United States District Court, E.D. Pennsylvania.

March 23, 2011.

*316 Joseph N. Williams, Brad A. Catlin, James A. Piatt, Price Waicukauski & Riley, Indianapolis, IN, Casandra A. Murphy, Barroway Topaz Kessler Meltzer & Check LLP, Radnor, PA, Andrew F. Kirkendall, Elizabeth Williams, Fletcher V. Trammell, Robert W. Cowan, Bailey Perrin Bailey, Houston, TX, Douglas A. Millen, Michael J. Freed, William H. London, Freed Kanner London & Millen LLC, Bannockburn, IL, Michael Coren, William D. Marvin, Cohen Placitella & Roth, Philadelphia, PA, Gerald Lawrence, Jr., Lowey Dannenberg Cohen PC, West Conshohocken, PA, Karen Iannace, Lowey Dannenberg Cohen Hart PC, White Plains, NY, for Plaintiffs.

Brian E. Hirsch, Cephalon, Inc., Frazer, PA, Erica Smith-Klocek, J. Gordon Cooney, Jr., Brian M. Ercole, Randall T. Undercofler, Susannah R. Henderson, Morgan Lewis & Bockius LLP, Philadelphia, PA, for Defendant.

MEMORANDUM

TUCKER, District Judge.

Presently before this Court is Defendant Cephalon, Inc.'s Motions for Summary Judgment pursuant to Fed.R.Civ.P. 56 (Docs. 230, 231), Plaintiffs' Response in Opposition to Defendant's Motions for Summary Judgment (Doc. 245), and Defendant's Replies thereto (Docs. 255, 256). Upon consideration of the parties' motions with exhibits and declarations, this Court will: (1) deny Defendant's Motions for Summary Judgment against Plaintiff Indiana Carpenters Welfare Fund, and (2) deny Defendant's Motions for Summary Judgment against Plaintiff Pennsylvania Turnpike Commission.

I. BACKGROUND

This class action suit, filed pursuant to 28 U.S.C. § 1332, arises from the alleged losses sustained by Plaintiffs at issue, Pennsylvania Turnpike Commission ("PTC") and the Indiana Carpenters Welfare *317 Fund ("ICWF").[1] The PTC and the ICWF (collectively, "Plaintiffs") allege that Defendant Cephalon, Inc. engaged in unlawful marketing of Actiq, a drug approved by the U.S. Food and Drug Administration ("FDA") for use by oncologists trained to prescribe Schedule II opioids to treat persistent pain in cancer patients. (Am. Compl. ¶¶ 1, 2, 3, 28.) Specifically, Plaintiffs allege that as third party payors for prescriptions of Actiq, they suffered monetary losses through the payment of "excessive prescription costs for treatment of conditions not approved by the FDA and for whom a wide array of less expensive pain management drugs were appropriate." (Am. Compl. ¶¶ 5, 61.) The excessive Actiq prescription costs shouldered by Plaintiffs were allegedly caused by Defendant's marketing and sale of the drug for purposes other than those approved by the FDA. (Am. Compl. ¶¶ 3, 5, 33.)

Defendant, a Delaware corporation with its principal place of business in Frazer, Pennsylvania, manufactures, sells, and markets pharmaceutical drugs. (Am. Compl. ¶ 13.) Actiq, manufactured by Defendant, is a Schedule II drug containing the highly addictive substance fentanyl, which makes it a drug with an associated risk of fatal overdose. (Am. Compl. ¶¶ 13, 25, 27.) In November 1998, the FDA granted restricted marketing approval for Actiq, limiting Defendant's marketing to cancer patients experiencing pain, "with malignancies who had developed a tolerance to less dangerous therapies." Furthermore, the FDA specified that Actiq should not be marketed for off-label uses, stating that the drug "must not be used in opioid non-tolerant patients" and must be prescribed solely to cancer patients by oncologists and pain specialists specifically trained in the use of Schedule II opioids to treat pain in cancer patients. (Am. Compl. ¶ 27.)

In 2000, Defendant generated $15 million in revenue from the sale of Actiq. The revenue realized by the Defendant increased sharply, so that by 2005, sales reached $412 million, making Actiq the second largest selling drug manufactured by Defendant. (Am. Compl. ¶ 34.) On September 6, 2006, the FDA further narrowed the scope of Actiq by placing an additional warning on its label indicating the dangerousness of the drug, and its potential for abuse, misuse or diversion. (Am. Compl. ¶ 32.) Plaintiffs contend that the explosion in Actiq sales were due to Defendant's illegal marketing scheme of targeting physicians "lacking experience in the use of Schedule II opioids and the treatment of cancer patients, and to patients without malignant cancer or a history of resistance to safer pain medication." (Am. Compl. ¶ 35.)

According to the Complaint, Defendant blatantly ignored its agreement with the FDA to limit its marketing and sales efforts to appropriately qualified oncologists and treatment of cancer patients, and instead marketed Actiq to "a wide range of doctors, including general practitioners, neurologists, and sports medicine specialists." *318 (Am. Compl. ¶ 41.) Evidence of Defendant's alleged wrongdoings include, but are not limited to, the following: (I) Defendant ignored the normal regulatory process mandated by the FDA to allow the promotion of a drug for purposes other than its FDA-approved use; (ii) in the first six months of 2006, a mere 1% of the 187,076 prescriptions filled for Actiq at retail pharmacies were prescribed by oncologists; (iii) Defendant's SEC Form 10-Q for the period ending June 30, 2002 attributed its 92% increase in Actiq sales to a "dedicated sales force" and "ongoing changes to our marketing approach"; (iv) Defendant failed to market Actiq solely to doctors who treated cancer patients, as evidenced in a Wall Street Journal article that reported one general practitioner's statement that Defendant's sales representative visited the physician once a month, and delivered upwards of 60 coupons for free Actiq at each visit. (Am. Compl. ¶¶ 40, 42, 44, 46.)

As further evidence of Defendant's illegal marketing practices, Plaintiffs reference government investigations against the Defendant.[2] The results of the investigation conducted by the Connecticut Attorney General's Office revealed that the Defendant used several wrongful tactics to illegally market Actiq for off-label purposes, with such tactics including, but not limited to the following: (I) the use of internal documents which instructed Defendant's sales representatives to provide physicians with coupons for free Actiq, despite the fact that such physicians indicated that they have no potential to treat cancer patients; (ii) instructing sales representatives to market Actiq to neurologists as a solution for migraine headaches; (iii) promoting the use of Actiq in physicians treating non-cancer patients by funding and controlling Continuing Medical Education seminars for physicians, and paying speakers to present topics concerning off-label uses of the drug; and (iv) using materially misleading, self-funded studies to promote off-label uses of the drug. (Am. Compl. ¶ 65.) In addition, in 2007 Defendant pled guilty and paid $425 million in settlement as a result of an investigation conducted by the U.S. Attorney's Office in Philadelphia, Pennsylvania concerning Defendant's sales and promotional practices for Actiq and two other drugs.[3] (Am. Compl. ¶ 62.)

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