United States Ex Rel. Radcliffe v. Purdue Pharma L.P.

582 F. Supp. 2d 766, 2008 U.S. Dist. LEXIS 81688, 2008 WL 4587783
CourtDistrict Court, W.D. Virginia
DecidedOctober 14, 2008
Docket1:05CV00089
StatusPublished
Cited by8 cases

This text of 582 F. Supp. 2d 766 (United States Ex Rel. Radcliffe v. Purdue Pharma L.P.) is published on Counsel Stack Legal Research, covering District Court, W.D. Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States Ex Rel. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. 2d 766, 2008 U.S. Dist. LEXIS 81688, 2008 WL 4587783 (W.D. Va. 2008).

Opinion

OPINION

JAMES P. JONES, Chief District Judge.

In this qui tam action, the defendants have moved to dismiss on several grounds, including the jurisdictional bar based on prior public disclosures of the alleged false claims, the execution of a pre-filing general release by the relator, and a failure to plead fraud with particularity under Rule 9(b). For the reasons set forth below, I deny the former two grounds of dismissal, but I will grant the motion under Rule 9(b), with leave to amend. 1

I. BackgRound.

In this action brought under the qui tam provisions of the False Claims Act (“FCA”), 31 U.S.C.A. §§ 3729-3733 (West 2003 & Supp.2008), and analogous state statutes, the relator Mark Radcliffe alleges that the defendants, Purdue Pharma, L.P. and Purdue Pharma, Inc. (collectively, “Purdue”), misrepresented to physicians the relative potency of Purdue’s eontrolled-released, oxycodone-based pain medication, OxyContin, which resulted in federal and state agencies, such as Medicaid, paying more than was necessary in reimbursement. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit.

This action was stayed for some time at the request of the federal government, which eventually declined to intervene, along with all of the thirteen state governments named in the Complaint. 2 Purdue *768 then filed the present Motion to Dismiss, seeking a dismissal on the grounds that Radcliffe’s claims are based on publicly disclosed information rather than information he discovered; that Radeliffe has released Purdue from the claims; and that the Complaint fails to adequately allege fraud as required by Federal Rule of Civil Procedure 9(b). 3

As to the defense that Radeliffe had released Purdue from the claims, I decided to treat the Motion to Dismiss as one for summary judgment in accord with Federal Rule of Civil Procedure 12(d). Further limited discovery and briefing was allowed as to that issue.

All of the issues are now ripe for decision and will be discussed sertiam.

II. The Public DisclosuRE BaR.

The FCA provides that there is no subject matter jurisdiction in a case where the claim is

based upon the public disclosure of allegations or transactions in a criminal, civil, or administrative hearing, in a congressional, administrative, or Government Accounting Office report, hearing, audit, or investigation, or from the news media, unless the action is brought by the Attorney General or the person bringing the action is an original source of the information.

31 U.S.C.A. § 3730(e)(4)(A). The purpose behind this bar, of course, is to “stifl[e] parasitic lawsuits.” United States ex rel. LaCorte v. Wagner, 185 F.3d 188, 191 (4th Cir.1999).

Because the public disclosure bar involves the jurisdiction of the court, it must be determined first, before proceeding to any other questions. United States ex rel. Wilson v. Graham County Soil & Water Conservation Dist., 528 F.3d 292, 309 (4th Cir.2008). In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. Id. at 308. The plaintiff has the burden of showing that the court has subject matter jurisdiction. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir.1982).

The facts on which I have determined jurisdiction are as follows.

In his job marketing OxyContin to physicians, the relator Radeliffe became familiar with claims made by Purdue about the medication’s relative cost and potency. Specifically, in his sales representative training, he alleges that he was taught that there was a 2:1 equianalgesic ratio between OxyContin and MS Contin, a rival pain medication containing morphine, making OxyContin twice as potent and, as a result, cheaper per dose than MS Contin. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians.

Radeliffe encountered skepticism from physicians he spoke with regarding Oxy-Contin’s relative cost and potency. Several of these physicians directed Radeliffe to specific sources in the scientific literature to show that the correct equianalgesic ratio between MS Contin and OxyContin was closer to 1:1, meaning that OxyContin was less potent and more expensive than Purdue claimed. These sources supported an equianalgesic ratio of 1:1 for chronic or around-the-clock dosing, but acknowledged *769 that single dose studies supported the 2:1 ratio. See Agency for Health Care Policy & Research, Public Health Serv., U.S. Dept. of Health & Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. C2 (Feb.1992) (“Clinical Practice Guideline”); United States Pharmacopeia-Dispensing Information 2238 tbl. 2 (16th ed 1996) (“USP”); Robert G. Twycross, Opioids, in Textbook of Pain 943, 953 tbl. 49.7 (Patrick D. Wall & Ronald Mezack eds.3d ed. 1994) (“Textbook of Pain”). Because MS Contin and OxyCon-tin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one.

When Radcliffe raised this concern to supervisors, he was told that by approving the OxyContin package inserts, which contained the 2:1 equianalgesic ratio as a starting conversion that could later be adjusted by doctors, the U.S. Food and Drug Administration (“FDA”) had approved that ratio. He was also told that Purdue’s decision to rely on the 2:1 ratio, despite published articles indicating that the 1:1 ratio was more appropriate for OxyContin’s approved use, was based on safety concerns, that is, it was better for doctors to start with a lower dose and adjust upward if necessary. These responses did not address the cost implications that concerned Radcliffe.

In his qui tam Complaint, 4 Radcliffe alleges that Purdue falsely and fraudulently, through its salesmen’s oral misrepresentations and the information presented in the OxyContin package insert, asserted to physicians and other decision-makers that there was a 2:1 equianalgesic ratio between OxyContin and MS Contin, and, thus, that OxyContin was cheaper per dose than MS Contin. He alleges that this was done to induce physicians to prescribe Ox-yContin and other decision-makers to purchase or authorize the purchase of Oxy-Contin. He submits that each OxyContin prescription submitted to the government for reimbursement constitutes a false claim under the FCA and the analogous state statutes, because the product distributed had only half the potency that physicians and decision-makers had been led to believe it possessed.

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582 F. Supp. 2d 766, 2008 U.S. Dist. LEXIS 81688, 2008 WL 4587783, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-radcliffe-v-purdue-pharma-lp-vawd-2008.