14-2299 (4th Cir. Decided: January 29, 2016. Further, the public policy concerns raised by Purdue do not alter the relative balance of public interests under the Rumery test. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. 2d at 1272. See Fed.R.Civ.P. Mr. Purdue Pharma L. P. et al, No. Mark Rad v. Purdue Pharma L.P. Filing 920100324. Purdue contends that Radcliffe released the claim made in his Complaint in the course of a settlement agreement with Purdue when he left its employment. Certain sealed material has been redacted from the publicly released copy of this opinion. Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. Id. (Mountcastle Decl. This subsection includes disclosures made in "criminal hearings," as well as those made in "administrative investigations," but I cannot see that, nor have the parties asserted that, either of these classifications applies to the current situation. Id. Dismiss 35.) 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. (Mountcastle Decl. 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. 2548, 91 L.Ed.2d 265 (1986). The general release executed by Radcliffe does not bar this action. The district court determined that between 1996 and 2005 Radcliffe, on behalf of Purdue, marketed "OxyContin, The final and perhaps the most difficult issue is whether the public disclosure reveals "allegations or, Full title:UNITED STATES, et al., ex rel. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. These include the public interest in having relators disclose inside information of alleged fraud to the government, in having relators supplement federal enforcement of the FCA by assisting the government in its investigation and prosecution or prosecuting the claim itself, and in deterring future fraud against the government. 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. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . 2d at 774. . . 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. They say it is a reflection on the decline of civility in the legal profession. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. Enforcement of a release to bar a subsequent qui tam suit implicates several articulated public interests. 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. 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. Id. and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." The allegation is contained in a motion asking U.S. District Judge Irene Berger, of the Southern District of West Virginia, to force the plaintiffs and their attorneys to pay the companys nearly $850,000 legal bill in the second case, which Berger dismissed on Oct. 31. 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. at 733-34 (remanding to allow leave to amend). Bahrani, 183 F. Supp. 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."). 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.'" 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. For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. The FCA provides that there is no subject matter jurisdiction in a case where the claim is. 1187. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. at 1512-13. 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 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." However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. 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.'" From Legal Newsline: Reach editor John OBrien at jobrienwv@gmail.com. Id. at 969. He later retracted that offer after being informed by a lawyer that he could not settle a qui tam suit. Id. The Ninth Circuit also relied on Davies v. Grossmont Union High School District, 930 F.2d 1390 (9th Cir. 2d at 1277. Id. Rabushka v. Crane Co., 40 F.3d 1509, 1512-14 (8th Cir. Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. Green, 59 F.3d at 956. 1999). The three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. Va.)) None of the misbranding charges pertained to the relative cost and potency issue. Id. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. 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." Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. Mark Rad v. Purdue Pharma L.P. Filing 920100324 Download PDF . [2] Id. In January and February of 2005 Radcliffe sent emails to several officers and directors of Purdue, using the alias "John Femaledeer." 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. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. 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 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. Months later, the former employee filed a qui tam complaint in federal court. Ten years ago, Mark Radcliffea former district sales manager for Purdue Pharma ("Purdue")filed a qui tam action under the FCA against Purdue. In 2010, his wife Angela and former underling May filed their own FCA lawsuit. 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. 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. (Reply Supp. 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. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: 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. J.A. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. A doctor relying on the 2:1 ratio would initially prescribe half as much OxyContin as MS Contin, which, according to the relators, did cost less, Berger wrote. 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. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. 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. See United States ex rel. 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. 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. 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. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. F. Brian Ferguson. Va. 2008). Compl. 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." 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. 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.'" at 960. The "John Femaledeer" emails indicate that Radcliffe did try to settle his claims with Purdue, but later retracted this offer after being told by an attorney that qui tam claims could not be settled without the government's consent. United States ex Noah Nathan v. Takeda Pharmaceuticals North America, Inc. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. 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. at 232. 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. Of course, it is plausible that a physician would be so induced by false representations concerning OxyContin's relative potency to write a prescription, ultimately paid for by the government. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. 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. For convenience, references herein to the "Complaint" shall include the most recent version. Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . 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. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. Springfield Terminal Ry. Kennedy v. Aventis Pharms., Inc., 512 F. Supp. They alleged these statements were made to doctors whose patients obtained prescriptions paid for by the government, creating a claim under the False Claims Act. Virginia Search this Docket Tags Get Alerts View on PACER Last Updated: Dec. 28, 2020, 6:49 a.m. EST Assigned To: James Parker Jones Referred To: Pamela M. Sargent Date Filed: Sept. 27, 2005 Date Terminated: Jan. 25, 2009 Date of Last Known Filing: June 1, 2010 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. 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. Id. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. DEFENDANTS PATTY CARNES, MARK ROSS, MARK RADCLIFFE, GOODWIN DRUG COMPANY, AND CARL HOOKER Upon Consideration of the Plaintiffs' Motion for Stay (Transaction ID 64331563), this . It has held that public policy is implicated only where "it is explicit, well defined and dominant, and ascertainable by reference to the laws and legal precedents and not from general considerations of supposed public interests." Id. Id. Id. All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." The package insert is currently posted to a section of Purdue's web page devoted to package inserts. 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). United States ex rel. 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, 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. That provision says the court may award reasonable attorneys fees and expenses if the court finds the lawsuit was clearly frivolous or vexatious or brought primarily for purposes of harassment. Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. 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. Unsealing the Complaint or allowing the suit to proceed would make a portion of the grand jury's pending investigation public. However, I believe that enforcing the release under these circumstances would substantially impact important public interests associated with the FCA. . 2001); United States ex rel. 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. 40 F.3d at 1510. (Information 20, United States v. Purdue Frederick Co., supra.) 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. 2d 815, 818 (S.D. However, that is not the situation before me. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. (f)(2).) Mark Radcliffe, 59, of Shady Spring, was convicted following a three-day jury trial. See United States ex rel. Supp. 1997), has been applied by subsequent federal courts faced with the issue. 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. 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. See DeCarlo, 937 F. Supp. Mark RADCLIFFE, Plaintiffs, v. PURDUE, Court:United States District Court, W.D. 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. The Ninth Circuit reversed, holding that a pre-filing release entered into without the government's knowledge or consent is not enforceable to bar a subsequent qui tam action because that would impair a substantial public policy. In this case, that information was the first FCA suit filed by Mark Radcliffe. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . 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. 2007). These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. This is factually distinct from the situation in which the government is in the midst of an ongoing investigation. C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 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. Instead both the 2001 posting and the current posting of the OxyContin package insert seem more akin to a corporate report or a press release. 5:2010cv01423 - Document 191 (S.D.W. 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. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. 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]. 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. However, neither case discusses the policy implications of enforcing a release in the context of the FCA. Id. 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. See id. Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. He also refers to, but does not cite, a single-dose study supporting the 2:1 ratio that he was told about by his supervisors at Purdue. Mark Rad v. Purdue Pharma L.P., No. Bell Tel. Va. 2014) case opinion from the Southern District of West Virginia US Federal District Court . 1994). However, the government ultimately took its investigation in a different direction, focusing on the misbranding of OxyContin as "less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications." Mistick PBT v. Hous. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. "); Longhi, 481 F. Supp. 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. 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. After the present qui tam suit was stayed, the government's investigation continued. ( Id. Id. Radcliffe was interviewed a second time in September 2006 and asked about the misleading promotion of OxyContin. at 965-66. 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. 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." (Information 20, United States v. Purdue Frederick Co., No. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. 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