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. These terms included those related to the issues of relative potency and cost, as well as those that seem more related to the potential for abuse or the effects of withdrawal. 2006). It further states that OxyContin is "indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time." Protected by Google ReCAPTCHA. The general release executed by Radcliffe does not bar this action. In 2010, his wife Angela and former underling May filed their own FCA lawsuit. The amended complaint does not contain allegations that connect the dots for even a single alleged false claim Berger wrote. 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. Purdue urges the court to consider pre- Green cases Virginia Impression Products Co. v. SCM Corp., 448 F.2d 262 (4th Cir. Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . Purdue Pharma Br. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. 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]. Id. Compl. at 1513-14. In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. On September 18 2014 Defendants hereinafter Purdue filed.20141009i18 Because the public disclosure bar involves the jurisdiction of the court, it must be determined first, before proceeding to any other questions. On Nov. 17, the company moved to have the plaintiffs pay its legal fees under the fee-shifting provisions in the FCA. 1994); United States ex rel. 1995), and United States ex rel Hall v. Teledyne Wah Chang Albany, 104 F.3d 230 (9th Cir. 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. 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. Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. Id. 2010), the district court dismissed . Gebert v. Transp. . He subsequently executed a general release ("the Release") of all claims against Purdue in order to receive an enhanced severance package. 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. Partial knowledge or investigation on the part of the government is insufficient to remove a case from the purview of Green into the exception created by Hall. Mot. Id. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. 2548, 91 L.Ed.2d 265 (1986). 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. 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. 2001); United States ex rel. 2d at 774. (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. 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. See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. 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. Were this the rule, a relator who initially tried to settle would have no incentive to disclose the allegations to the government in lieu of settlement. 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. Will be used in accordance with our terms of service & privacy policy. Green, 59 F.3d at 956. Gilligan v. Medtronic, Inc., 403 F.3d 386, 389 (6th Cir. After the present qui tam suit was stayed, the government's investigation continued. Further, because parties engaged in the fraud would be able to settle their claims with potential relators for significantly less than they would once the government became aware of the allegations, the FCA's deterrent effect is also lessened. 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. Grayson v. Pac. It reasoned that "[t]here is no public disclosure to the American public when information is divulged in a foreign publication, especially if published in a foreign language." Mot. Id. 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. In addition to ruling the whistleblowers failed to sufficiently plead their allegations, Berger also found that their suit was barred by a rule that says whistleblowers cant bring suit over information that has already been made public. 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. 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 . Accordingly, I do not address Purdue's second argument that the package insert is a public disclosure from an administrative investigation. 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. Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. 1348 (quoting Fed.R.Civ.P. 434. 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.'" 49.7 (Patrick D. Wall Ronald Mezack eds. 104 F.3d at 231. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. 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. Id. Given the international nature of the scientific community, there is no indication that the publication of this article in a foreign scientific journal makes it any less accessible to the American public than if it were published in a scientific journal located in the United States. Id. 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. The plaintiff has the burden of showing that the court has subject matter jurisdiction. at 1513. See United States ex rel. Although antitrust cases are similar to qui tam suits in that the government relies on the enforcement efforts of private parties, the policy implications and economic incentives differ. 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. 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. 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. 2d 569, 576 (W.D. 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, L.P. (1:05-cv-00089) District Court, W.D. The relator would likely be willing to accept a lower overall settlement amount from the other party, knowing that he would receive the entire amount, rather than only a portion of the settlement. Springfield Terminal Ry. DeCarlo v. Kiewit/AFC Enters., Inc., 937 F. Supp. 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. 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. Decided: January 29, 2016. Both were published in scientific periodicals. U.S. ex Rel. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. at 817. Purdue cites United States ex rel. Id. The motion says the whistleblowers attorney, Hurt, knewthe two would take up the baton after the first FCA suit was dismissed and that the two did not have personal knowledge of the allegations of fraud they would make against Purdue, claiming they even contradicted the claims made in the complaint during their testimony. 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. . With respect to allegations of fraud, "the `circumstances' required to be pled with particularity under Rule 9(b) are `the time, place, and contents of the false representations, as well as the identity of the person making the misrepresentation and what he obtained thereby.'" Id. Finally, the government's decision not to intervene in this suit, announced on May 8, 2007, should not be a basis for enforcement of the release. (f)(2).) Id. Hall, 104 F.3d at 231. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. 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. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. 481 F. Supp. (Reply Supp. 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. Va. 1989). J. Clin. While the results of this study were not published until 1999, an abstract including the 2:1 equianalgesic ratio was published in 1996. 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. J.A. 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. It is implausible to believe that doctors consistently used the 2:1 ratio as a starting point, prescribed significantly greater amounts as they titrated the dosage to the patients, and continued to believe OxyContin to be cost-effective based on the 2:1 ratio. Supp. Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. (Third Am. School escapes liability for sex abuse by teacher, Walmart launches Constitutional attack on Lina Khan's FTC, Firefighters fired over penises drawn on Black colleague's family pictures lose lawsuit, Lawsuit targets Panera's Sip Club, complains refills have restrictions, Judge stops 3M's plan to handle massive earplug litigation. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 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. Certain sealed material has been redacted from the publicly released copy of this opinion. But that is not sufficient to meet the rigorous standard of Rule 9(b). For these reasons, I find that this court his subject matter jurisdiction over the Complaint. Id. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. Longhi v. Lithium Power Techs., Inc., 481 F. Supp. United States ex rel. (Mountcastle Decl. at 963. Purdue argues that in the present case, the following constitute public disclosures: (1) published scientific articles and reference materials cited in the Complaint, which support an equianalgesic ratio of 1:1 between MS Contin and OxyContin for repeated dosing, but note the existence of single-dose studies that support a ratio of 2:1; (2) a single-dose study that supports an equianalgesic ratio of 2:1 and a published article and an abstract reporting the results of this study; (3) other materials published in scientific journals, which support the 2:1 equianalgesic ratio for longer-term use, that Purdue argues Radcliffe would have been familiar with in his employment; and (4) the OxyContin package insert, which was approved by the FDA and was, at one time, available on Purdue's web site. Single alleged false claim Berger wrote court must determine the facts based on the evidence submitted to have plaintiffs! 655 ; United States ex rel the 2:1 equianalgesic ratio was published in.! 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