1996). 2d at 1278. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. at 733-34 (remanding to allow leave to amend). 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." Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. Purdue urges the court to consider pre- Green cases Virginia Impression Products Co. v. SCM Corp., 448 F.2d 262 (4th Cir. Mark Rad v. Purdue Pharma L.P. Filing 920100324. Purdue Pharma is represented by John Hoblitzell III and Rebecca Betts of Kay Casto & Chaney in Charleston, W.Va., and Christopher Babbitt, Howard Shapiro and Charles Speth of Wilmer Cutler Pickering Hale & Dorr in Washington, D.C. On Oct. 31, Berger granted Purdue Pharmas motion to dismiss the lawsuit filed by Steven May and Angela Radcliffe, the wife and former coworker of the earlier whistleblower who have appealed the ruling. He alleged a fraudulent scheme whereby Purdue marketed 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." Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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]. Green, 59 F.3d at 962. 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."). 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. at 1513. 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. and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." Purdue Pharma, L.P. (1:05-cv-00089) District Court, W.D. 2d at 1272. 1348 (quoting Fed.R.Civ.P. 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. 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. 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. 2d 569, 576 (W.D. Although the criminal charges did relate to the misbranding of OxyContin, these charges focused on Purdue's marketing of OxyContin as "less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications." In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. But see United States ex rel. Matsushita Elec. 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, Id. 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. 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. Disclosures made in other public forums do not implicate the public disclosure bar. 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. In doing so, the court relied on the test set forth in Town of Newton v. Rumery, 480 U.S. 386, 107 S.Ct. . In September, the Department of Justice contacted Purdue's outside counsel with electronic search terms designed to capture documents [Redacted]. at 817. United States District Court, W.D. Wilson, 528 F.3d at 299. 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. All of the issues are now ripe for decision and will be discussed sertiam. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. In January and February of 2005 Radcliffe sent emails to several officers and directors of Purdue, using the alias "John Femaledeer." Radcliffe was interviewed a second time in September 2006 and asked about the misleading promotion of OxyContin. Pharmacol. Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. 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. at 966. 2d. 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. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. Decided: January 29, 2016. To meet this requirement, it is sufficient that there have been either (1) disclosures of both a false state of facts and a true state of facts (not necessarily from the same source) so that fraud is implied; or (2) disclosure of an allegation of fraud, regardless of the specificity of the allegation. Hall involved an employer who had been accused of fraud on the government by an employee. However, I believe that enforcing the release under these circumstances would substantially impact important public interests associated with 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. at 1512-13. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. This is factually distinct from the situation in which the government is in the midst of an ongoing investigation. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. Redactions are denoted in brackets. According to Scheininger, Wells mentioned several times that she wished to ask these witnesses about the dispute over the relative potency of OxyContin and MS Contin, among other topics, explaining that this related to the marketing and cost implications of the relative potencies. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. 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 . United States ex rel. Contract Educ. at 969. Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. . 1999). Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. App. 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. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. Servs., 260 F.3d 909, 916 (8th Cir. Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . 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. 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. at 308. 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. 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. Id. 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. 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. of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. These sources supported an equianalgesic ratio of 1:1 for chronic or around-the-clock dosing, but acknowledged that single dose studies supported the 2:1 ratio. F. Brian Ferguson. 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." Radcliffe was a district sales manager for Purdue, laid off as part of a reduction in force in June 2005. 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. Id. Whitten v. Triad Hosps., Inc., No. at 963. 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. . . 2010). However, he states that no details of the alleged misconduct were given and the attorney did not identify the name of his client. 2007). 2d 766, 774 (W.D. I agree. 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. Wilson v. Graham County Soil Water Conservation Dist., 528 F.3d 292, 309 (4th Cir. Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. 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. 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. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). 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 stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. 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 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. During this period . As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. Purdue cites Gebert, 260 F.3d 909, in which the government did not investigate until after the filing of the qui tam complaint and the court ultimately chose to enforce the release. Id. Radcliffe also avers that. Purdue Pharma L.P., et al., Civil Action Nos. (Mem. 56(e)). 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. Accordingly, I find that under these circumstances, enforcement of the release would undermine important public interests associated with the FCA, as well as the countervailing interest in settling litigation. at 963. Mr. United States of America, et al. This case stemmed from a qui tam action under the FCA that Mark Radcliffe ("Radcliffe"), a former district sales manager for Purdue Pharma ("Purdue"), filed against Purdue, alleging that Purdue improperly labeled the drug OxyContin as having a higher pain . Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. 1995); State ex rel. at 965-66. Id. Id. Auth. Id. 104 F.3d at 231. The package insert recommends a starting conversion rate between OxyContin and MS Contin of 2:1, which can be reassessed based on a patient's reaction to the dosage. 1994). Dismiss 35.) 9 n.4. See id. Doyle v. Diversified Collection Services, Inc., No. All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." 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 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. "); Longhi, 481 F. Supp. Protected by Google ReCAPTCHA. 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. If so, was the qui tam action based on the public disclosure? 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. 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. (Mountcastle Decl. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. United States ex rel. 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.. Green v. Serv. Further, the public policy concerns raised by Purdue do not alter the relative balance of public interests under the Rumery test. The Ninth Circuit also relied on Davies v. Grossmont Union High School District, 930 F.2d 1390 (9th Cir. 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. On August 1, 2005, he signed a severance agreement, which included a general release of all claims against Purdue. formerly a sales representative for Purdue under Mark Radcliffe's supervision. 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. Subsequent cases have not addressed this type of argument. 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. 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). They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. Gilligan v. Medtronic, Inc., 403 F.3d 386, 389 (6th Cir. 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.'" MEMORANDUM OPINION AND ORDER R. CLARKE VanDERVORT Magistrate Judge. Defs.' Purdue Pharma L.P., No. 1994); United States ex rel. The Fourth Circuit follows a three-step approach in determining whether the public disclosure bar applies. United States ex rel. With respect to Radcliffe's delay in filing his qui tam suit, I agree that this does weigh in favor of enforcement as a means to encourage relators to file quickly and disclose their allegations to the government as soon as possible. Yannacopolous v. General Dynamics, 315 F. Supp. Id. 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. 582 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, Co., 142 Cal. 2006). On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . The parties have been provided with the sealed copy. 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 facts surrounding this defense have been developed in the summary judgment record. Va. 1989). Both were published in scientific periodicals. In such cases, I can hardly think that the mere fact of a government investigation would negate the public interest in having a private citizen shoulder the burden of prosecution that would allow the government to recover monies lost through fraud. 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. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. Finally, if the action was based on the public disclosure, was the relator an original source? Purdues arguments to the contrary are misleading and miss the point.. 3d ed. 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. Mistick PBT v. Hous. Id. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Grayson v. Pac. (Defs.' Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. 434. regarding the relative potency of oxycodone." The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. The facts on which I have determined jurisdiction are as follows. See United States v. Purdue Frederick Co., 495 F. Supp. 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. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. 2010), the district court dismissed . On September 27, 2005, Radcliffe filed his qui tam Complaint. 1999); Rabushka, 40 F.3d at 1514. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. Be impaired by enforcement of the alleged misconduct were given and the accuracy ``... Dose studies supported the 2:1 ratio dose studies supported the 2:1 comparison of OxyContin when marketing it to.. Department of Justice contacted Purdue 's outside counsel with electronic search mark radcliffe purdue pharma to. 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