Had the substance of the relator's allegations been disclosed to an appropriate employee at the FDA with the authority to investigate these claims, that might have constituted a disclosure in an administrative investigation. at 1513. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. Likewise, the prior public disclosures reveal that there was contradicting scientific evidence as to the relative potency of OxyContin to MS Contin, but they do not imply fraud. 2d. Id. Mountcastle argued that the suit could hinder the investigation because while Purdue was aware of the investigation "no mention ha[d] been made that the 2:1 comparison of OxyContin and MSContin [was] one of the areas under investigation." Id. United States ex rel. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. On Nov. 17, Purdue Pharma alleged attorney Mark Hurt of Abingdon, Va., used information from a previous, unsuccessful whistleblower lawsuit against Purdue Pharma to file another through the plaintiffs wife and former coworker. Id. Mark Rad v. Purdue Pharma L.P. Filing 920100324. Angela said her knowledge of the alleged fraud came from conversations with her husband, while May alleged some of his knowledge came from conversations with Mark and some came from observations during his own employment. It is unclear from Hall whether the NRC was made aware of the identity of the specific person making the allegations when it first investigated the matter. The general release executed by Radcliffe does not bar this action. Purdue argues that Radcliffe was a bad actor who waited to file his qui tam complaint and, prior to doing so, attempted to settle with Purdue in exchange for an investment in a company he was starting. While the 1999 article was published in European Journal of Clinical Pharmacology, it was authored by scientists in the United States and written in the English language. During the course of the agency's investigation, the employee was terminated and initiated a state court action, which did not include a qui tam claim. at 960. 1997), has been applied by subsequent federal courts faced with the issue. In September and December of 2005, the Department of Justice contacted Purdue with electronic search terms, some of which pertained to the relative cost and potency issue. The three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. 2007). If not, then the court balances "all the factors that bear on whether `the public interest in enforcement of the agreement outweigh the policies furthered by non-enforcement.'" 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. Id. The citations it relies on to support this argument are inapposite or misleading. Id. Id. 2010). 2d at 820 ("If there is a dividing line to be found between Hall and Green, it is the fullness of the government's investigation, not the timing of the release."). However, that is not the situation before me. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. Id. Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. It has been held that disclosures made directly to relevant government officials, rather than to the public, can constitute public disclosures in administrative investigations when the disclosure is made "to a competent public official" "who has managerial responsibility for the very claims being made." He subsequently executed a general release ("the Release") of all claims against Purdue in order to receive an enhanced severance package. 1039, 1043-47 (S.D.N.Y. As a result, such a rule would reward potential defendants who encourage settlement and would impair the public interest in having relators disclose information to the government. Servs., 260 F.3d 909, 916 (8th Cir. The plea agreements included settlement of certain of the government's civil claims, but not of Radcliffe's qui tam suit. The amended complaint does not contain allegations that connect the dots for even a single alleged false claim Berger wrote. United States ex rel. One of their attorneys is Mark He relies on United States ex rel. Specifically, he alleged that Purdue fraudulently marketed OxyContin using the 2:1 equianalgesic ratio, thus claiming that its relative cost was less than that of MS Contin. during the depositions of Mark and Angela Radcliffe and Steven May respecting commu nications between Relators and Mark Radcliffe and Relators and their attorneys with Mark . ), aff'd, 53 F. App'x 153 (2d Cir. C05-01962 HRL, 2006 WL 2067061 (July 25, 2006) at *7 ("[T]he key question is whether the government knew about [the relator's] allegations of fraud and had an opportunity to investigate them before the release was executed. The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. In his job marketing OxyContin to physicians, the relator Radcliffe became familiar with claims made by Purdue about the medication's relative cost and potency. In summary, Purdue argues that the public disclosures in these scientific articles and in the OxyContin package insert amount to a disclosure of the fraudulent transactions alleged in Radcliffe's qui tam suit and put the government on notice of the potential fraud. Congress deemed this necessary because of reluctance on the part of insiders to come forward with relevant knowledge of fraud as well as federal enforcement agencies' relative lack of resources to investigate and prosecute allegations of fraud, leaving some potentially significant cases unaddressed. Redactions are denoted in brackets. Reply to Resp. In his qui tam Complaint, 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. 1187, 94 L.Ed.2d 405 (1987), that "`a promise is unenforceable if the interest in its enforcement is outweighed in the circumstances by a public policy harmed by enforcement of the agreement.'" Section 3730(e)(4)(A) provides an exclusive list of sources that may give rise to a public disclosure that will strip a court of subject matter jurisdiction: "disclosures in (1) criminal, civil, or administrative hearings; (2) congressional, administrative, or Government [Accountability] Office reports, hearings, audits, or investigations; and (3) the news media." Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. 1995), and United States ex rel Hall v. Teledyne Wah Chang Albany, 104 F.3d 230 (9th Cir. Radcliffe was a district sales manager for Purdue, laid off as part of a reduction in force in June 2005. While the court reasoned that the enforceability of the release should be governed by federal law because it arose under federal law, the court did not address any of the public policy concerns associated with qui tam suits or the FCA. Hall involved an employer who had been accused of fraud on the government by an employee. However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. at 966. The allegations claimed Purdue Pharma marketed OxyContin with a false claim that a patient could use half as much OxyContin as MS Contin to treat the same pain. (f)(2).) The facts surrounding this defense have been developed in the summary judgment record. Bell Tel. After carefully considering the arguments of the parties, I hold that the Complaint does not adequately state a claim for fraud under Rule 9(b). I agree. 434. This case stemmed from a qui tam action under the FCA that Mark Radcliffe ("Radcliffe"), a former district sales manager for Purdue Pharma ("Purdue"), filed against Purdue, alleging that Purdue improperly labeled the drug OxyContin as having a higher pain . at 963. Id. ex rel. For the purposes of addressing the public disclosure issue, the Complaint and the Third Amended Complaint contain the same claims and neither party has indicated that any relevant public disclosures were made between the date the Complaint was file and the date that the Third Amended Complaint was filed. 1187. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. 1994); United States ex rel. It is unclear from the Complaint and subsequent filings whether Radcliffe ever read this study or merely heard about it from the supervisors and physicians. Id. Green, 59 F.3d at 962 (quoting Rumery, 480 U.S. at 392), 107 S.Ct. Also on July 28, the government issued a subpoena for Michael Cullen, [Redacted]; he was later asked during his grand jury testimony about the relative potency issue. United States ex Noah Nathan v. Takeda Pharmaceuticals North America, Inc. Document production requests made by the government and conversations between lawyers representing the government and Purdue or its employees in June and July of 2005 suggest that the government was trying to learn more about the relative cost and potency issue. The facts on which I have determined jurisdiction are as follows. Likewise, the public interest in using qui tam suits to supplement federal enforcement of the FCA was not disturbed as the government had already investigated the allegations prior to the release. Mark Radcliffe, 59, of Shady Spring, was convicted following a three-day jury trial. The final settlement in the criminal case did not contain any reference to the relative cost and potency issue and did not purport to settle Radcliffe's suit. Notwithstanding the government's lack of knowledge of or consent to the release, because the federal government was already aware of the allegations of fraud, the public interest in having information disclosed to the government was not implicated. These responses did not address the cost implications that concerned Radcliffe. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. If anything on the record suggests fraud with respect to the relative cost and potency, it is the relator's statements regarding his experiences in being trained to market OxyContin and his questioning of his supervisors about the relative potency issue, as well as the internal training materials that explained how to address the relative cost issue with physicians. Purdue contends that, under Hall, enforcement of a release to bar a subsequent qui tam action is appropriate even if the government has not completed its investigation. 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). To the extent that Radcliffe derived the allegations in his Complaint from either of these sources, these will be considered public disclosures in the news media. Regardless, the 1996 abstract was published in Clinical Pharmacology Therapeutics, a scientific journal headquartered in Alexandria, Virginia. From Legal Newsline: Reach editor John OBrien at jobrienwv@gmail.com. Va. 2008). at 963. 5:2010cv01423 - Document 191 (S.D.W. 1991), which builds upon the Rumery test. Purdue Pharma L. P. et al, No. By this time, the government had also begun drafting Grand Jury Subpoena 513, which included requests for all documents discussing relative analgesic potency or safety of OxyContin and MS Contin. the plaintiff-relator, mark radcliffe ("radcliffe"), filed a qui tam suit in the united states district court for the western district of virginia alleging that his former employer, purdue pharma, l.p. ("purdue"), defrauded the government by marketing its pain-relief drug, oxycontin, as a cheaper alternative to the drug it replaced, ms contin, However, the government ultimately took its investigation in a different direction, focusing on the misbranding of OxyContin as "less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications." The government's decision not to intervene "does not necessarily signal governmental disinterest in an action, as it is entitled to most of the proceeds even if it opts not to intervene." Once it decided to fashion a uniform rule on the enforceability of pre-filing releases, the Ninth Circuit turned to Rumery, 480 U.S. at 392, to structure its discussion of competing policy concerns. Yannacopolous v. General Dynamics, 315 F. Supp. DeCarlo v. Kiewit/AFC Enters., Inc., 937 F. Supp. In his Complaint, Radcliffe cites the three publications shown to him by the physicians the Clinical Practice Guideline, the USP, and the Textbook of Pain to support the correctness of the 1:1 ratio. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: J.A. Longhi involved a release executed eleven days after the relator filed a qui tam complaint. 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). After the qui tam suit was initiated, the NRC revisited its prior investigation and reached the same conclusions. However, to the extent that Radcliffe actually did base his qui tam allegations on these articles, these will be considered public disclosures in the news media. Id. Thus, I find that these constitute public disclosures in the news media. 2001); United States ex rel. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. Id. The Fourth Circuit agreed that the district court did not have jurisdiction over the claims and affirmed. Several months later, Purdue restructured its sales force and Radcliffe was offered the option of transferring positions, which he declined, or termination with an extended severance package. While this would seem to be the case in Hall since the federal government had not only completed its investigation, but concluded that the allegations could not be substantiated, this does not mean that there are not other cases that the government may have investigated fully but determined that it would not prosecute on its own for a variety of reasons, such as the low amount of money involved compared to the cost of prosecution, the low likelihood of success, or the lack of government resources to pursue it. MEMORANDUM OPINION AND ORDER R. CLARKE VanDERVORT Magistrate Judge. at 733-34 (remanding to allow leave to amend). Purdue has withdraw that argument, including its related Request for Judicial Notice. 4th 741, 754-55 (Cal.Ct.App. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. As in Bahrani, when the release was executed there was no guarantee that the government would end up prosecuting based on the relator's allegations. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. Longhi v. Lithium Power Techs., Inc., 481 F. Supp. at 1043-46. In mid-July 2005 the government reviewed and flagged numerous documents in the possession of four Purdue employees, [Redacted]. This furthers the public interests in encouraging a potential relator to disclose his allegations to the government as quickly as possible, before the government has an opportunity to discover the alleged wrongdoing through other means. Green v. Serv. Ramseyer recalls receiving a telephone call from a West Virginia attorney regarding a possible qui tam suit against Purdue at some point prior to September 27, 2005. 2 (16th ed 1996) ("USP"); Robert G. Twycross, Opioids, in Textbook of Pain 943, 953 tbl. Howard M. Shapiro and Jennifer M. O'Connor, Wilmer Cutler Pickering Hale and Dorr LLP, Washington, D.C., and Howard C. McElroy, McElroy, Hodges, Caldwell, Abingdon, VA, for Purdue Pharma L.P. and Purdue Pharma, Inc. Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . 2006). This implies that the government was by that point aware of the substance of allegations, but more importantly that those facets of their investigations were still ongoing, beyond the date of the release. 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. See id. The court did not inquire into the fullness of the government's investigation. The plaintiff-relator, Mark Radcliffe ("Radcliffe"), filed a qui tam suit in the United States District Court for the West-ern District of Virginia alleging that his former employer, Purdue Pharma, L.P. ("Purdue"), defrauded the government . To meet this requirement, it is sufficient that there have been either (1) disclosures of both a false state of facts and a true state of facts (not necessarily from the same source) so that fraud is implied; or (2) disclosure of an allegation of fraud, regardless of the specificity of the allegation. If a substantial public interest would be impaired, the court need not engage in the Rumery balancing test unless there is an articulated reason favoring enforcement aside from the "`interest in the settlement of litigation,'" as that "`cannot by itself outweigh a substantial public interest on the other side of the scales.'" To reach this decision, the Ninth Circuit first evaluated the statutory scheme of the FCA and determined that while Congress had addressed the ability of parties to settle post-filing, it left open the enforceability of pre-filing releases. Specifically, Purdue argues that the single-dose study, other scientific articles, and its OxyContin package insert, which recommend an equianalgesic ratio of 2:1 between OxyContin and MS Contin, represent the alleged "false" state of facts, while scientific sources cited by Radcliffe in the Complaint, which recommend a ratio of 1:1, represent the "true" state of facts. (c) and (f)(2)). 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit Coleson, which was decided prior to Green but after Rumery, involved a claim brought under the anti-retaliation provisions of the FCA, rather than a qui tam claim brought on behalf of the government. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. I think it is sufficient under Hall that the government know of the substance of the allegations. Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. Id. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. (Defs.' 2d 766, 774 (W.D. Instead both the 2001 posting and the current posting of the OxyContin package insert seem more akin to a corporate report or a press release. Summary judgment is appropriate only if there are no material facts in dispute and the moving party is entitled to judgment as a matter of law. Va.)) None of the misbranding charges pertained to the relative cost and potency issue. (Mountcastle Decl. Purdue argues that, under Rumery, the circumstances present here do not implicate the public interests articulated in Green, do not outweigh the general interest in settling litigation, and, thus, support enforcement of the release to bar this qui tam suit. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). at 1512-13. Purdue Pharma L.P., et al., Civil Action Nos. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). Dismiss, Exs. Pharmacol. Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. While the OxyContin package insert recommends the 2:1 conversion ratio as a starting point for doctors switching patients from MS Contin to OxyContin, it also suggests the need to reevaluate based on each individual patient's response to the new medication. He was not asked about the relative cost or potency of OxyContin and MS Contin, nor was he asked about the equianalgesic ratio of these two drugs. 458 (S.D.N.Y. Id. Both were published in scientific periodicals. 9 n.4. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. The state court action resulted in a settlement and general release, which was executed more than a year after the agency had completed its investigation. at 817. (c).) Although the 2001 posting of the OxyContin package insert could be considered either a corporate report or a press release, because it was posted on a web page entitled "News What's New" and because other items on the page resemble press releases, I will consider the OxyContin package insert a public disclosure in the news media. Id. It was dismissed for failure to plead fraud with sufficient particularity. 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. Takeda Pharmaceuticals North America, Inc of Radcliffe 's qui tam complaint 1272, 1275-78 ( Colo.. 'S qui tam suit was initiated, the 1996 abstract was published in scientific and medical periodicals! Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 ( 2d Cir 2002 ) see... 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