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]. Va. 2008). He subsequently executed a general release ("the Release") of all claims against Purdue in order to receive an enhanced severance package. 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. 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. 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. at 966. 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.'" See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. 1999); Rabushka, 40 F.3d at 1514. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. 2007). 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. Modification of these search terms occurred in December, 2005. 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. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. The one silver lining is that this behavior is largely limited to big city law practice, in which lawyers rarely appear regularly in the same court against the same opposing counsel, the response says. 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. Auth. The Newsletter Bringing the Legal System to Light. 1997), has been applied by subsequent federal courts faced with the issue. 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. 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. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. 31 U.S.C.A. 763 (E.D. But see United States ex rel. Mistick PBT v. Hous. In his Complaint, Radcliffe alleges that Purdue "encouraged physicians to write prescriptions that were paid by Medicaid and other government programs for OxyContin that was materially less potent . In responding to Purdue Pharmas allegations, the attorneys say the whistleblowers have always been upfront that their knowledge of the alleged scheme was second-hand. Id. 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. 2d 815, 818 (S.D. 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." In addition to this source requirement, the disclosure must have been of the "allegations or transactions" on which the qui tam action is based, not merely of information used by the qui tam relator. at 1512-13. For convenience, references herein to the "Complaint" shall include the most recent version. at 820. Purdue urges the court to consider pre- Green cases Virginia Impression Products Co. v. SCM Corp., 448 F.2d 262 (4th Cir. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. Id. at 956-57. 3730(e)(4)(A); see United States ex rel. 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 . 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. In Rabushka, a shareholder filed suit alleging that his conversations with company executives demonstrate that they fraudulently understated unfunded pension liability and spun off one of the company's components in order to shift responsibility for the pensions to another entity. 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). 1348 (quoting Fed.R.Civ.P. The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. On May 10, 2007, the government filed a criminal information against a related Purdue entity and several Purdue executives, along with executed plea agreements for all the criminal defendants. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. (f)(2).) 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. Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . Gebert v. Transp. Id. Dismiss 20.) Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. at 233. 2d at 1272. 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. 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. Mot. 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." 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. When Radcliffe raised this concern to supervisors, he was told that by approving the OxyContin package inserts, which contained the 2:1 equianalgesic ratio as a starting conversion that could later be adjusted by doctors, the U. S. Food and Drug Administration ("FDA") had approved that ratio. 425, 428 (1999). The facts surrounding this defense have been developed in the summary judgment record. at 1513-14. 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. 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. A separate order will be entered herewith. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). In doing so, the court relied on the test set forth in Town of Newton v. Rumery, 480 U.S. 386, 107 S.Ct. As early as 1996, Radcliffe found that some of the physicians he spoke to were skeptical of this 2:1 ratio. While Purdue concedes that a defendant may be liable for inducing a third party to submit a false claim to the government, it argues that Radcliff's allegations do not meet the Rule 9(b) pleading requirements because he does not describe even a single instance in which a physician was influenced to prescribe OxyContin based on Purdue's misrepresentations, and where a claim for payment was made by the pharmacist to the government. 2d at 774. 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." 1996). 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). 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. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. In 2010, his wife Angela and former underling May filed their own FCA lawsuit. Co., 142 Cal. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. However, neither case discusses the policy implications of enforcing a release in the context of the FCA. Id. 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. 1995); State ex rel. After the action was filed, the United States investigated the qui tam relator's allegations, but ultimately chose not to intervene. That agency investigated and concluded that it could not substantiate the allegations. 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. 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." Purdue cites United States ex rel. Purdue does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. formerly a sales representative for Purdue under Mark Radcliffe's supervision. (Mountcastle Decl. at 963-64. 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."). 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. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. 3729-3733 (West 2003 & Supp.2008), and analogous state statutes, the relator Mark Radcliffe alleges that the defendants, Purdue Pharma, L.P. and Purdue Pharma, Inc. (collectively, "Purdue"), misrepresented to physicians the relative potency of . 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. 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. Further, this shareholder-relator was the first to allege that company executives knew of the extent of the underfunding at the time of the spin off and that the liability was large enough to place the company in jeopardy of failing. Id. See id. Defs.' Tex. Radcliffe was interviewed a second time in September 2006 and asked about the misleading promotion of OxyContin. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. Id. Will be used in accordance with our terms of service & privacy policy. Instead of the 2:1 ratio Purdue Pharma claimed, the actual ratio was more like 1.5:1, the whistleblowers said. 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. The FCA provides that there is no subject matter jurisdiction in a case where the claim is. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. 56(e)). 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. Supp. On August 1, 2005, he signed a severance agreement, which included a general release of all claims against Purdue. Disclosures made in other public forums do not implicate the public disclosure bar. However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. Dismiss 11.) Redactions are denoted in brackets. Reply to Resp. Green v. Serv. See Fed.R.Civ.P. Bell Tel. One of their attorneys is Mark Va. 1989). 2001); United States ex rel. 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. United States ex rel. at 308. 582 F. Supp. While allegations of fraud were known to the Department of Justice, they had not been publically disclosed within the meaning of 3730(e)(4)(A). 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. 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. 1999). Radcliffe v. Purdue Pharma L.P., 582 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. See United States v. Purdue Frederick Co., 495 F. Supp. 30.) These responses did not address the cost implications that concerned Radcliffe. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. Mark RADCLIFFE, Plaintiffs, v. PURDUE, Court:United States District Court, W.D. 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.. 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. Hall, 104 F.3d at 231. All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." 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." Bahrani, 183 F. Supp. It was dismissed for failure to plead fraud with sufficient particularity. Id. Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. Radcliffe was interviewed by law enforcement agents on October 28, 2005. Grayson v. Pac. 2548, 91 L.Ed.2d 265 (1986). These disclosures suggest legitimate scientific debate and disagreement regarding the correct equianalgesic ratio, rather than any fraudulent intent on the part of Purdue. Rabushka v. Crane Co., 40 F.3d 1509, 1512-14 (8th Cir. 3729-3733 (West 2003 & Supp.2008), and analogous state statutes, the relator Mark Radcliffe alleges that the defendants, Purdue Pharma, L.P. and Purdue Pharma, Inc. (collectively, "Purdue"), misrepresented to physicians the relative potency of . 2d 1158, 1164-65 (N.D. Ill. 2007). at 733-34 (remanding to allow leave to amend). at 1278. and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." 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. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. The plaintiff has the burden of showing that the court has subject matter jurisdiction. United States ex rel. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. Id. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. 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. 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. at 1047. 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. Purdues arguments to the contrary are misleading and miss the point.. 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. 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. This line of reasoning has been adopted by the Eighth Circuit, Gebert, 260 F.3d at 916, and the Southern District of New York, DeCarlo, 937 F. Supp. 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. The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. 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. He relies on 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. 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. 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. 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. 1999). (Reply Supp. Plaintiff - Appellant: UNITED STATES EX REL. 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. The court found no statutory or policy reasons to prevent enforcement of the release. Bahrani v. Conagra, Inc., 183 F. Supp. (Mountcastle Decl. dismissing complaint because it did "not describe even a single instance in which a physician was influenced to prescribe [the drug] based on [the defendant's] misrepresentations, and where a claim was made by the pharmacist to the government". United States ex rel. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. He alleged a fraudulent scheme whereby Purdue marketed Mark Radcliffe, 59, of Shady Spring, who previously owned and operated shuttered pain clinics in Kanawha City and Raleigh County, was found guilty of conspiracy to tamper with a witness and aiding . In this case, that information was the first FCA suit filed by Mark Radcliffe. The published scientific articles and reference materials cited by Radcliffe in his Complaint the Clinical Practice Guideline, the USP, and the Textbook of Pain fall within the "news media" category of 3730(e)(4)(A) and constitute public disclosures. Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. 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. Unsealing the Complaint or allowing the suit to proceed would make a portion of the grand jury's pending investigation public. I think it is sufficient under Hall that the government know of the substance of the allegations. Doyle v. Diversified Collection Services, Inc., No. United States ex rel. 1994); United States ex rel. of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. Id. 2010). Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . Green, 59 F.3d at 956. 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. He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." Dismiss 35.) In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. F. Brian Ferguson. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. See id. 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. In holding that these disclosures did not raise the inference that company executives intentionally and fraudulently understated the pension problem or engineered the spin off in an attempt to avoid liability, the court noted that none of the disclosures imputed any bad faith or wrongdoing to the company and instead were "optimistic" about the company's future. Id. 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). Compl. In the conclusion of the response, the attorneys say Purdues allegations of bad faith and its personal attack on them are a lamentable tactic used to get an advantage in litigation. 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. The government stated that without the relator's assistance following the release date it could not have issued a warrant to obtain documents or made sense of those documents when received and that given that these documents were not received until several weeks after the release date, the government had not had the opportunity to fully investigate prior to the execution of the release. at 1043-46. Later, in Hall, the Ninth Circuit carved out an exception to the general rule against enforcing pre-filing releases to bar subsequent qui tam suits: where the government has full knowledge of the allegations and an opportunity to investigate these prior to the release, the release will be enforceable and will bar a later qui tam suit. Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. Radcliffe signed a general release of all claims against Purdue in exchange for an enhanced severance package. at 821. . Mark Radcliffe, 59, of Shady Spring, was convicted following a three-day jury trial. After all, they were suing Purdue, not for any injuries that they had personally suffered, but for Purdues fraud against the Government, a response filed Dec. 4 says. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. United States ex rel. Id. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. (c) and (f)(2)). Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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. Casetext, Inc. and Casetext are not a law firm and do not provide legal advice. 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.. Given the vast array and varying credibility of web pages on the Internet, I am not ready to conclude that anything posted online would automatically constitute a public disclosure within the meaning of 3730(e)(4)(A). Once the moving party has met its burden, "the nonmoving party must come forward with `specific facts showing that there is a genuine issue for trial.'" Whitten v. Triad Hosps., Inc., No. at 1513. Id. 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. See DeCarlo, 937 F. Supp. It is undisputed that Radcliffe did not disclose the nature of his qui tam allegations to the government prior to the filing of his Complaint. 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. 458 (S.D.N.Y. 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. Id. U.S. ex Rel. 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. 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). (Information 20, United States v. Purdue Frederick Co., No. Angela Radcliffe (the "Relators") commenced this FCA action against Purdue ("Qui Tam II") setting forth allegations nearly identical to those advanced by Mark Radcliffe in Qui Tam I. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. It further reasoned that "[t]he public's interest in [the relator] maintaining the ability to bring a qui tam action to supplement federal enforcement of the FCA also remained as there was no guarantee when [the relator] executed the Release that the federal government was ever going to investigate, let alone prosecute," the alleged fraud. 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. Further, the public policy concerns raised by Purdue do not alter the relative balance of public interests under the Rumery test. Servs., 260 F.3d 909, 916 (8th Cir. United States ex rel. 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. at 963. 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. Purdue next argues that other scientific publications supporting an equianalgesic ratio of 2:1, not only for single or intermittent dosing but also for longer-term use, are public disclosures because "[a]s a Purdue sales representative and supervisor, Radcliffe would have been trained on and intimately familiar with many Purdue articles endorsing a 2:1 equianalgesic potency ratio." Months later, the former employee filed a qui tam complaint in federal court. ), aff'd, 53 F. App'x 153 (2d Cir. Id. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. Id. 1994). While these disclosures all reveal true information regarding the current state of the scientific debate, they do not reveal the "true" state of facts regarding the fraud alleged by the relator, that is, that Purdue used the 2:1 ratio despite knowing that it was inaccurate in order to mislead physicians and other decision-makers regarding the relative cost and potency of OxyContin. Va. 2007) (accepting plea agreements). 4th 741, 754-55 (Cal.Ct.App. He was also told that Purdue's decision to rely on the 2:1 ratio, despite published articles indicating that the 1:1 ratio was more appropriate for OxyContin's approved use, was based on safety concerns, that is, it was better for doctors to start with a lower dose and adjust upward if necessary. 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. & Training Trust Fund. Purdue has withdraw that argument, including its related Request for Judicial Notice. While these public disclosures do demonstrate some disagreement or debate over the appropriate equianalgesic ratio, I am not convinced that they sufficiently raise the specter of fraud. 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. The facts on which I have determined jurisdiction are as follows. at 969. Defs.' United States ex rel. at 960. 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. Finally, if the action was based on the public disclosure, was the relator an original source? . 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. MEMORANDUM OPINION AND ORDER R. CLARKE VanDERVORT Magistrate Judge. 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." Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. Subsequent cases have not addressed this type of argument. 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. 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. All of the issues are now ripe for decision and will be discussed sertiam. (Third Am. 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. 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 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. Purdue Pharma, L.P. (1:05-cv-00089) District Court, W.D. 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. 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). They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. Relators claims had no objectively reasonable chance of success, the company argues. 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. Apparently Radcliffe later experienced more doubts because in 2004 he sought legal advice and in January 2005 he anonymously contacted Randy Ramseyer, an Assistant United States Attorney for the Western District of Virginia, to gauge the government's interest in a claim against Purdue. 1991), which builds upon the Rumery test. 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. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. Id. 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. 2d 766, 774 (W.D. 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." . 434. Id. Mark Rad v. Purdue Pharma L.P. Filing 920100324 Download PDF . (Mountcastle Decl. The employer in Green argued that because the government had ultimately become aware of the allegations and conducted its own investigation, the release would not have detrimental effects. 1187. 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. 2007). 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." . 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.'" Purdue Pharma L. P. et al, No. at 818. CV202-189, 2005 WL 3741538, at *5 (S.D. The plea agreements included settlement of certain of the government's civil claims, but not of Radcliffe's qui tam suit. at 965-66. 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. 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.'" Yannacopolous v. General Dynamics, 315 F. Supp. 2d 569, 576 (W.D. 2d at 1277. The citations it relies on to support this argument are inapposite or misleading. Id. 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Of `` the 2:1 comparison of OxyContin to MSContin. R. CLARKE VanDERVORT Magistrate Judge 389 ; see States. Former employee filed a qui tam suit a lengthy investigation after the execution the! The relator an original source he could potentially still have been developed in the light most favorable to government!
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