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In Re: Actiq Sales and Marketing Practices Litigation v. Cephalon

March 23, 2011


The opinion of the court was delivered by: Tucker, J.


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.


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 Fund ("ICWF"). *fn1 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." (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. *fn2 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. *fn3 (Am. Compl. ¶ 62.)

On May 19, 2008, Plaintiffs filed their First Amended Consolidated Class Action Complaint in the United States District Court of the Eastern District of Pennsylvania against the Defendant. The remaining claims at issue are Counts III and IV of the Complaint, which set forth claims alleging Defendant's violations of state consumer protection fraud laws, and unjust enrichment received by Defendant as a result of such violations. *fn4

Plaintiffs seek to recover hundreds of millions of dollars through the following requested relief: (I) damages in the amount of monies paid for Actiq; (ii) actual damages, statutory damages, punitive or treble damages, and such other relief as provided by the statues serving as the basis for their claims; (iii) pre and post judgment interest on all monetary relief; (iv) equitable relief in the form of restitution, including restitutionary disgorgement into a fluid recovery fund, to restore monies received by Defendant as a result of its alleged unlawful conduct; (v) other appropriate injunctive relief; (vi) litigation costs, including attorneys' fees; and (vii) all other relief to which Plaintiffs and members of the Class represented by Plaintiffs may be entitled at law or in equity. (Am. Compl. ¶¶ 1, 126.)


Summary judgment is appropriate where the movant establishes that "there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56©; see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Levy v. Sterling Holding Co., LLC, 544 F.3d 493, 501 (3d Cir. 2008). The threshold inquiry is whether there are "any genuine factual issues that properly can be resolved only by a finder of fact because they may reasonably be resolved in favor of either party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250 (1986) (noting that no triable issue exists unless there is sufficient evidence favoring the nonmoving party for a jury to return a verdict in its favor). See also Dee v. Borough of Dunmore, 549 F.3d 225, 229 (3d Cir. 2008). The moving party must show that if the evidentiary material of record were reduced to admissible evidence in court, it would be insufficient to permit the non-moving party to carry its burden of proof. See Celotex, 477 U.S. at 327 (1986).

Once the movant has carried its burden under Rule 56, "its opponent must do more than simply show that there is some metaphysical doubt as to the material facts." Scott v. Harris, 550 U.S. 372, 380 (2007) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986)). Under Rule 56(e), the opponent must set forth specific facts showing a genuine issue for trial and may not rest upon the mere allegations or denials of its pleadings. See Martin v. Godwin, 499 F.3d 290, 295 (3d Cir. 2007). If the opposing party does not so respond, summary judgment should, if appropriate, be entered against that party." Fed. R. Civ. P. 56(e)(2). At the summary judgment stage, the court's function is not to weigh the evidence and determine the truth of the matter, but rather to determine whether there is a genuine issue for trial. See Anderson, 477 U.S. at 249; Jiminez v. All American Rathskeller, Inc., 503 F.3d 247, 253 (3d Cir. 2007). In doing so, the court must construe the facts and inferences in the light most favorable to the non-movant. See Matsushita, 475 U.S. at 587; Horsehead Indus., Inc. v. Paramount Commc'ns, Inc., 258 F.3d 132, 140 (3d Cir. 2001). The court must award summary judgment on all properly supported issues submitted by the moving party unless the non-movant shows, through affidavits or admissible evidence, that an issue of material fact remains. See, e.g., Love v. Rancocas Hosp., 270 F. Supp. 2d 576, 579 (D.N.J. 2003); Koch Materials Co. v. Shore Slurry Seal, Inc., 205 F. Supp. 2d 324, 330 (D.N.J. 2002).


A. Choice of Law

As a preliminary matter, the Court will address the applicable choice of law for the claims before it. Under Pennsylvania federal choice of law rules, the Court must apply the law of the state with the greater interest in the matter at hand. This inquiry into state interest is to be performed qualitatively, by analyzing relevant contacts. Hammersmith v. TIC Ins. Co., 480 F.3d 220, 230-31 (3d Cir. 2007). Furthermore, the Court "must apply an individualized choice of law analysis to each plaintiff's claims." Georgine v. Amchem Prods., 86 F.3d 610, 627 (3d Cir. 1996). Thus, the Court must determine the applicable law under which it will analyze Defendant's summary judgment motion with respect to both Plaintiff ICWF's and Plaintiff PTC's claims. First, the Court will determine whether Plaintiff ICWF's claims shall be analyzed under Indiana or Pennsylvania consumer protection laws.

Step one in the choice of law analysis requires the court to determine whether an actual conflict exists between two state laws. Hammersmith, 480 F.3d at 229. The Indiana Deceptive Consumer Sales Act ("IDCSA"), sets forth the following relevant provisions constituting deceptive practices:

The following acts, and the following representations as to the subject matter of a consumer transaction, made orally, in writing, or by electronic communication, by a supplier, are deceptive acts:

(1) That such subject of a consumer transaction has sponsorship, approval, performance, characteristics, accessories, uses or benefits it does not have which the supplier knows or should reasonably know it does not have. . . .

(7) That the supplier has a sponsorship, approval, or affiliation in such consumer transaction the supplier does not have, and which the supplier knows or should reasonably know that the supplier does not have. Ind. Code § 24-5-0.5-3(a)(1), (7) (emphases added). . . .

(a) A supplier commits a deceptive act if the supplier gives any of the following representations, orally or in writing, or does any of the following acts:

(1) Either:

(A) solicits to engage in a consumer transaction without a permit or other license required by law;

(B) solicits to engage in a consumer transaction if a permit or other license is required by law to engage in the consumer transaction and the supplier is not qualified to obtain the required permit or other license or ...

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