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. Lack of compliance with the pleading requirements of Rule 9(b) is treated as a failure to state a claim under Rule 12(b)(6). App. 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. DeCarlo, 937 F. Supp. By the end of July, the government had also begun drafting Grand Jury Subpoena 513 which included requests for all documents discussing the relative analgesic potency or safety of OxyContin and MS Contin. . Longhi involved a release executed eleven days after the relator filed a qui tam complaint. See id. See United States ex rel. Id. 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. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. J.A. 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. Id. 3d ed. Finally, if the action was based on the public disclosure, was the relator an original source? On June 24, 2005, a conversation took place between Department of Justice attorney Barbara Wells and attorney Michael Scheininger, who represented several Purdue employees, about topics that would be discussed when those employees testified before the grand jury investigating Purdue. The package insert is currently posted to a section of Purdue's web page devoted to package inserts. 1999). Compl. The court stated that the defendant "informed the [NRC] of Hall's concerns," but it does not necessarily follow that in doing so Hall was identified to the NRC. Kennedy v. Aventis Pharms., Inc., 512 F. Supp. 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. 458 (S.D.N.Y. Servs., 260 F.3d 909, 916 (8th Cir. Generally, this does not require that the disclosure be of the specific allegations brought by the relator, but instead the disclosure must put the government on notice of the likelihood of fraudulent activity. 40 F.3d at 1510. Ultimately, the Ninth Circuit found that the significant public interests at issue when a potential relator and potential defendant execute a release, without the government's knowledge or consent, prior to the filing of a qui tam complaint outweighed the general interest in settling litigation and determined that, as a rule, such pre-filing releases were not enforceable to bar the subsequent qui tam actions. 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. The government's investigation continued and on December 5, 2005, AUSA Mountcastle moved to stay Radcliffe's qui tam suit pending the government's ongoing investigation. Radcliffe also avers that. 1999). of Pittsburgh, 186 F.3d 376, 385 (3d Cir. For convenience, references herein to the "Complaint" shall include the most recent version. Pharmacol. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. 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. I am troubled by the fact that Radcliffe's behavior, in waiting until the Department of Justice had already begun a criminal investigation into other allegations of marketing fraud committed by Purdue, before filing his qui tam action, suggests that he is an opportunistic relator. 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. Co., 142 Cal. 434. 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]. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. Id. 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. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. 1991), which builds upon the Rumery test. Id. To determine whether the circumstances of a case fall within the general rule articulated in Green or the exception in Hall, the critical issue is the completeness of the government's knowledge or the fullness of its investigation. 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. I agree. Make your practice more effective and efficient with Casetexts legal research suite. Purdue has withdraw that argument, including its related Request for Judicial Notice. Id. It is not entirely obvious why the Ninth Circuit concluded that a full investigation negates the public interest in having a qui tam supplement federal enforcement, which includes not only disclosing information to the government, but also potentially investigating and prosecuting the case on behalf of the government. Id. at 817. 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. (Mountcastle Decl. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. United States ex rel. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. The term "news media" includes scholarly, scientific, and technical periodicals, including trade journals, because, like newspapers, these sources disseminate information to the public in a periodic manner. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. The "John Femaledeer" emails indicate that Radcliffe did try to settle his claims with Purdue, but later retracted this offer after being told by an attorney that qui tam claims could not be settled without the government's consent. Mot. But see United States ex rel. For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. Contract Educ. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. Purdue Pharma L.P., et al., Civil Action Nos. This rule would also make the enforcability of such a release dependant on the government's intervention decision and may discourage some potential relators from initiating qui tam suits in the first place, leaving some allegations undisclosed. Defs.' 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. Id. According to Assistant United States Attorney Rick A. Mountcastle, "one area of investigation concern[ed] whether Purdue falsely marketed OxyContin as being twice as potent as morphine and, accordingly, less expensive than MSContin." In finding the release unenforceable, the court reasoned that the limited knowledge of the allegations held by the government did not negate the public interest in providing incentives for the relator to fully disclose inside information concerning the allegations to the government. 2d 939, 949 (N.D. Ill. 2004), which held that newspaper articles published in Greek in the Greek press did not constitute disclosures to the American public. 1187. Casetext, Inc. and Casetext are not a law firm and do not provide legal advice. Finally, Purdue submits that Radcliffe should have known of, and did not deny knowledge of, other studies supporting the 2:1 ratio for longer-term use. Mr. Auth. Dismiss 11.) The generalized interest in settling litigation is outweighed in the present circumstances by public interests that would be impaired by enforcement of this release, and so analysis under the Rumery test does not favor enforcing Radcliffe's release. The three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. Counsel also stated that on July 28, 2005, she spoke to an attorney from the Department of Justice who expressed an interest in using electronic searches to identify documents [Redacted]. Mark Rad v. Purdue Pharma L.P., No. 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. McLean v. County of Santa Clara, No. Id. In this case, that information was the first FCA suit filed by Mark Radcliffe. Decided: January 29, 2016. at 966. Id. 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 . 3730(e)(4)(A); see United States ex rel. 425, 428 (1999). at 1512. All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." at 733-34 (remanding to allow leave to amend). The Fourth Circuit follows a three-step approach in determining whether the public disclosure bar applies. Id. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. As the release involved a statutorily-conferred federal right, the Ninth Circuit turned to federal common law to fill this "gap" in the statutory scheme. 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. Grayson v. Pac. Looking at the specific web page cited by Purdue, it appears that on July 18, 2001, the OxyContin package insert was posted to a section of Purdue's web page entitled "News What's New." Va. 2014) case opinion from the Southern District of West Virginia US Federal District Court . He alleged a fraudulent scheme whereby Purdue marketed the baton" and file the qui tam action against Purdue now before the court. 1039, 1043-47 (S.D.N.Y. Michael Scheininger, counsel to several Purdue employees, stated that Department of Justice lawyer Barbara Wells informed him on June 24, 2005, of her intent to ask several of his clients about the dispute over the relative potency of OxyContin and MS Contin, explaining that it related to the marketing and cost implications. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. to Mot. Id. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. He relies on United States ex rel. The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. 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.'" The circumstances here fall within the general rule articulated in Green that pre-filing releases are unenforceable to bar subsequent qui tam actions, rather than the Hall exception, because the government had not fully investigated the substance of Radcliffe's allegations. & Training Trust Fund. 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. 1994); United States ex rel. Purdue does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. 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 case previously reached the U.S. Court of Appeals for the Fourth Circuit, which refused to dismiss the case based on a lack of specific allegations because the whistleblowers still had the opportunity to amend their complaint. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. He also refers to, but does not cite, a single-dose study supporting the 2:1 ratio that he was told about by his supervisors at Purdue. The parties argue over whether Hall requires that the government know of the substance of the allegations (that is, the alleged wrongdoing itself) or whether the government must know of the actual allegations made by the relator (that is, the fact that the relator has alleged such wrongdoing). 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. This subsection includes disclosures made in "criminal hearings," as well as those made in "administrative investigations," but I cannot see that, nor have the parties asserted that, either of these classifications applies to the current situation. 2006). On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . 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. 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. Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. The court held the release unenforceable both because it was executed within the statutory sixty-day investigatory period and interfered with the government's ability to evaluate whether to intervene in the suit and because it was contrary to public policy under the Green/Hall framework. 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. United States ex rel. 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