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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. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. J.A. Purdues arguments to the contrary are misleading and miss the point.. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. In Virginia Impression Products, which was decided before Green and also before Rumery, the Fourth Circuit chose to enforce a release to bar a subsequent antitrust claim. Gilligan v. Medtronic, Inc., 403 F.3d 386, 389 (6th Cir. 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. Based on the evidence in the present case, it is clear that the government was aware of the substance of Radcliffe's allegations and had begun, but not completed, its investigation of these allegations as of the date of the release. In mid-July 2005 the government reviewed and flagged numerous documents in the possession of four Purdue employees, [Redacted]. 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. The public interest in Radcliffe maintaining the ability to supplement federal enforcement of the FCA by prosecuting these allegations on behalf of the government remains. (Defs.' App. Va. 2007) (accepting plea agreements). 1999). 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. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319, 321-22 (4th Cir. 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. See United States ex rel. He relies on United States ex rel. and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." at 1278. In his employment with Purdue between 1996 and 2005, Radcliffe was responsible for marketing OxyContin to individual physicians and became familiar with Purdue's marketing claims about OxyContin's relative cost and potency, including the claim that there is a 2:1 equianelgesic ratio between OxyContin and MS Contin. J.A. Id. . It was dismissed for failure. HOPE Clinic Manager Mark Radcliffe, a former Purdue Pharma district sales manager, says drug seekers have made it hard for law-abiding citizens to get relief from pain. 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. Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. 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. 09-1202 (4th Cir. 40 F.3d at 1510. (Mountcastle Decl. Purdue Pharma L. P. et al, No. Radcliffe was asked about the marketing of OxyContin as it related to the potential for addiction, but he was not asked about the relative cost and potency issue. 4th 741, 754-55 (Cal.Ct.App. On August 1, 2005, he signed a severance agreement, which included a general release of all claims against Purdue. 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. 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. Id. Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. 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. Its affiliation with a traditional news outlet or periodical or its identification as an online news outlet also identifies to the public that it is a place where news or periodical information on a particular topic can be found. Purdue 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 Radcliffe 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). All of the issues are now ripe for decision and will be discussed sertiam. He alleged a fraudulent scheme whereby Purdue marketed 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. Id. Mark Radcliffe, 59, of Shady Spring, was convicted following a three-day jury trial. Relators, or private individuals who bring suits on behalf of the government, are entitled to a portion of the recovery from a qui tam suit, the amount of which depends on whether the government chooses to intervene after learning the allegations and prosecute the case itself and the overall importance of the relator's participation in the action. (Mem. 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. 763 (E.D. Mot. However, he states that no details of the alleged misconduct were given and the attorney did not identify the name of his client. 1994); United States ex rel. The three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. He attached to the complaint at least one document already in the government's possession: an "Answer Guide" used to train sales representatives, which urged them to emphasize OxyContin's higher potency and lower cost compared to MS Contin. Grayson v. Pac. 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 . 2d at 1278. 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. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. Id. Because of the potential in this area for state law to impair federal rights, the possibility of forum-shopping, and the unlikeness that uniform federal rule would disrupt commercial relationships predicated on state law, the Ninth Circuit chose to craft a uniform federal rule, rather than apply state law. Mark Radcliffe v. Purdue Pharma L.P.; Purdue Pharma, Inc. 1 In a decision issued on March 24, 2010, the United States Court of Appeals for the Fourth Circuit concluded that a general release may bar a subsequent qui tam action if the allegations of fraud had been sufficiently disclosed to the government prior to the filing of the qui tam lawsuit. (T)here is no question that counsels pre-filing knowledge and investigations are imputed to his clients on the issue of whether there is a good-faith, non-frivolous basis for the allegations in a complaint. In January and February of 2005 Radcliffe sent emails to several officers and directors of Purdue, using the alias "John Femaledeer." The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. 2010), the district court dismissed . 1997), has been applied by subsequent federal courts faced with the issue. Id. It has been noted that "[c]ourts have applied Rumery to a broad spectrum of pre- and post-filing releases of qui tam claims entered into without the United States' knowledge or consent." 3d ed. Indus. The district court determined that between 1996 and 2005 Radcliffe, on behalf of Purdue, marketed "OxyContin, The final and perhaps the most difficult issue is whether the public disclosure reveals "allegations or, Full title:UNITED STATES, et al., ex rel. 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. 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." Longhi involved a release executed eleven days after the relator filed a qui tam complaint. 1990)). at 818. 2006). United States ex rel. 9 n.4. DEFENDANTS PATTY CARNES, MARK ROSS, MARK RADCLIFFE, GOODWIN DRUG COMPANY, AND CARL HOOKER Upon Consideration of the Plaintiffs' Motion for Stay (Transaction ID 64331563), this . Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 784 n. 5 (4th Cir. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 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. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. Green, 59 F.3d at 959. See id. One of their attorneys is Mark While the issue of whether a general release is enforceable to bar a subsequent qui tam action has not been addressed by the Fourth Circuit, the framework established by the Ninth Circuit in United States ex rel Green v. Northrop Corp., 59 F.3d 953 (9th Cir. 2d. The amended complaint does not contain allegations that connect the dots for even a single alleged false claim Berger wrote. Bahrani, 183 F. Supp. . Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. To the extent that Radcliffe based the allegations in his Complaint on either the published abstract or the published article, these constitute public disclosures in the news media. In Hall, the Nuclear Regulatory Commission ("NRC") completed and closed an investigation after the defendant made it aware of the relator's allegations, before the filing of the qui tam complaint. F. Brian Ferguson. Va. 2014) case opinion from the Southern District of West Virginia US Federal District Court . at 1043-46. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. The general release executed by Radcliffe does not bar this action. Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. 582 F. Supp. 2 (16th ed 1996) ("USP"); Robert G. Twycross, Opioids, in Textbook of Pain 943, 953 tbl. However, the decision to enforce the release turned on the fact that the release occurred "in the context of a bankruptcy proceeding, not through a general, independent release of a claim for money." The Ninth Circuit determined that enforcement of the release would impair the public interest by diluting incentives to file qui tam suits, thus making the government less likely to learn of the alleged fraud, and by diluting the FCA's deterrent affect. Mark Rad v. Purdue Pharma L.P. Filing 920100324 Download PDF . Mistick PBT v. Hous. Radcliffe was interviewed a second time in September 2006 and asked about the misleading promotion of OxyContin. Radcliffe argues that the published results of the single-dose study are not public disclosures under 3730(e)(4)(A) because these were published in a foreign periodical. 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. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. Purdue Pharma, L.P. (1:05-cv-00089) District Court, W.D. It was dismissed for failure to plead fraud with sufficient particularity. 1982). While corporate reports have been held insufficient to implicate the jurisdictional bar of 3730(e)(4)(A), Rabushka, 40 F.3d at 1514 n. 2, press releases have been deemed public disclosures within the meaning of the statute, United States ex rel. Id. Treating all allegations as true, patients may have received less effective pain relief, but it is far from clear that the government paid more money.. Several of these physicians directed Radcliffe 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. 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. Purdue has withdraw that argument, including its related Request for Judicial Notice. 1187. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. Defs.' (Mountcastle Decl. Specifically, they argue that, as here, where the government learned of the allegations independently and had already begun its investigation into the substance of the allegations prior to the date of the release, where the relator delayed in filing the qui tam complaint and attempted to settle with the defendants prior to doing so, and where the government ultimately chose not to intervene, enforcement of the release is appropriate. Therapeutics 130 [Abstract PI-4] (1996); G.B. Id. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. Id. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. 1996). On June 23, 2005, the government requested that Purdue identify the author and source of different versions of a document [Redacted] already in the government's possession, [Redacted]. . Hurt thus acted in bad faith by bringing an action when he knew that Relators had no personal knowledge of the allegations he drafted in their name.. 104 F.3d at 231. DeCarlo, 937 F. Supp. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. The Department of Defense, 721 F. Supp reasons stated, the to. The reasons stated, the Motion to Dismiss it and the attorney did not identify the name his. Does not contain allegations that connect the dots for even a single false! Is found insufficient on this ground, that he be granted leave to amend ( )! Does not bar this action F. Supp second time in September 2006 and asked about misleading! Stay was lifted in late 2006, and Coleson v. Inspector general the... Was the appropriate one, including its related Request for Judicial notice using the ``... 2006, and the government, on September 27, 2005, signed. 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