See id. 56(e)). In 2010, his wife Angela and former underling May filed their own FCA lawsuit. Id. the baton" and file the qui tam action against Purdue now before the court. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. at 1277-78. 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. The parties have been provided with the sealed copy. Radcliffe has amended his Complaint three times since it was originally filed, so that Purdue's Motion to Dismiss actually relates to the Third Amended Complaint filed June 5, 2007. 1039, 1043-47 (S.D.N.Y. More than a year later, after he had executed the release, the relator was contacted by USDA investigators and at this time he provided detailed information regarding his allegations. . See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. Because I find that these scientific articles and the OxyContin package insert, taken together, do not disclose or imply fraud, and, thus, do not constitute a public disclosure of the allegations or transactions within the meaning of 3730(e)(4)(A), I need not address the extent to which Radcliffe based his allegations on these materials, nor whether he was an original source. 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. 425, 428 (1999). If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. United States ex rel. Id. ), aff'd, 53 F. App'x 153 (2d Cir. Id. Admin. Bahrani, 183 F. Supp. C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. 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. For instance, this web page could be affiliated with a news publication and, as such, would be updated regularly and would disseminate information to the public in a periodic manner. See United States v. Purdue Frederick Co., 495 F. Supp. 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 . 1996). Enforcing a release in this situation would deprive the public of a potential relator to enforce the FCA and recover monies for the government treasury. 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. 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. Virginia, Abingdon Division. Indus. The district court granted summary judgment to the defendants who argued that, as part of the release, the relator had bargained away his right to bring the qui tam suit and as a result could not demonstrate any personal stake in the outcome sufficient to satisfy Article III standing. See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. Id. Because a relator is only entitled to a portion of the proceeds from a successful qui tam suit, both the relator and the party accused of fraud could benefit financially by settling before the government learns of the allegations. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. Id. With respect to the settlement attempts, it would seem counterintuitive to enforce a release to bar a subsequent qui tam suit, thus foreclosing the relator's ability to prosecute on behalf of the government, to punish that relator for trying to settle instead of filing suit in the first place. Both were published in scientific periodicals. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. 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. at 963. Finally, if the action was based on the public disclosure, was the relator an original source? 1348 (quoting Fed.R.Civ.P. Thus, I find that these constitute public disclosures in the news media. at 821. United States ex rel. Thus, the exception created by Hall provides that a release entered into after the government has full knowledge of the allegations and an opportunity to investigate will be enforced to bar a subsequent qui tam suit. Purdue has withdraw that argument, including its related Request for Judicial Notice. As in Green, the Ninth Circuit in Hall relied on the Rumery test, but concluded that the concerns that weighed against enforcement in Green were not present. at 1513-14. 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). Id. 1982). Purdue Pharma, L.P. (1:05-cv-00089) District Court, W.D. Radcliffe was a district sales manager for Purdue, laid off as part of a reduction in force in June 2005. Instead of the 2:1 ratio Purdue Pharma claimed, the actual ratio was more like 1.5:1, the whistleblowers said. As to the defense that Radcliffe 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). (f)(2).) Id. Id. C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. During this time the government was conducting a criminal investigation of Purdue's marketing of OxyContin, eventually resulting in guilty pleas in this court by a related company and three of Purdue's top executives. 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." However, it is also clear from the evidence that the government continued to seek such information after the release had been executed on August 1, 2005. . Va.)) None of the misbranding charges pertained to the relative cost and potency issue. 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. 458 (S.D.N.Y. These disclosures suggest legitimate scientific debate and disagreement regarding the correct equianalgesic ratio, rather than any fraudulent intent on the part of Purdue. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. Mot. 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. Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. For convenience, references herein to the "Complaint" shall include the most recent version. Kennedy v. Aventis Pharms., Inc., 512 F. Supp. DeCarlo, 937 F. Supp. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319, 321-22 (4th Cir. Mark Rad v. Purdue Pharma L.P. Filing 920100324. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. 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. In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. 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. at 1512. 434. Thus, allowing enforcement of such a release to bar a subsequent qui tam suit undermines the financial incentives thought necessary by Congress to ensure that those with inside knowledge file qui tam suits alerting the government of the alleged fraud and potentially assisting the government with its investigatory and prosecutory burden. 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. Evidence presented in Bahrani demonstrated that, prior to executing a general release, the relator had two brief conversations with an FBI agent prior in which he made charges against his employer but offered no specifics regarding the alleged fraud. Longhi v. Lithium Power Techs., Inc., 481 F. Supp. Radcliffe was interviewed by law enforcement agents on October 28, 2005. The general release executed by Radcliffe does not bar this action. The qui tam provisions are designed to supplement government enforcement of the FCA by using financial incentives to encourage insiders privy to fraud on the government to disclose this inside knowledge and potentially prosecute violations. 3730(e)(4)(A); see United States ex rel. Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. 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. Id. 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. 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. Pharmacol. 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. 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. Further, such a rule would mean that the enforceability of the release would be uncertain until such time as the government chose whether to intervene, which would undermine the countervailing interest in settlement of litigation. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. 481 F. Supp. 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. 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. 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.'" F. Brian Ferguson. Some studies recommended an equianalgesic ratio of 1:1, particularly for chronic, around-the-clock dosing; they acknowledged studies that recommended a ratio of 2:1 for single or intermittent doses. 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. at 1512-13. United States ex rel. It is important to note that 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." (Mem. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. 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