mark radcliffe purdue pharma

Id. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. Mark Rad v. Purdue Pharma L.P. Filing 920100324 Download PDF . Green, 59 F.3d at 962 (quoting Rumery, 480 U.S. at 392), 107 S.Ct. 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. 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. 1990)). Bahrani, 183 F. Supp. In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. Id. 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 . at 308. 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.. 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. [2] Admin. Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. They say it is a reflection on the decline of civility in the legal profession. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. 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. 1039, 1043-47 (S.D.N.Y. 1:07-CR-00029 (W.D. 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." DeCarlo, 937 F. Supp. 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. (Information 20, United States v. Purdue Frederick Co., supra.) 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. 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. 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." Make your practice more effective and efficient with Casetexts legal research suite. The package insert is currently posted to a section of Purdue's web page devoted to package inserts. DeCarlo v. Kiewit/AFC Enters., Inc., 937 F. Supp. 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. ), aff'd, 53 F. App'x 153 (2d Cir. 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. Therapeutics 130 [Abstract PI-4] (1996); G.B. Purdue Pharma, L.P. (1:05-cv-00089) District Court, W.D. 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. 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. Further limited discovery and briefing was allowed as to that issue. 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. Under 3730(e)(4), an action is properly dismissed for lack of subject matter jurisdiction only if there was a public disclosure on which the relator's allegations were based and that relator is not an original source. 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. 1348 (quoting Fed.R.Civ.P. MEMORANDUM OPINION AND ORDER R. CLARKE VanDERVORT Magistrate Judge. Reply to Resp. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. In September and December of 2005, the Department of Justice contacted Purdue with electronic search terms, some of which pertained to the relative cost and potency issue. 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". Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. 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. Wilson v. Graham County Soil Water Conservation Dist., 528 F.3d 292, 309 (4th Cir. at 733-34 (remanding to allow leave to amend). Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . 2006). 56(e)). Nathan v. Takeda Pharmaceuticals N.A. 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. Va. 2007) (accepting plea agreements). 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). Because of my disposition of the case, I do not reach Purdue's arguments that some of the claims may be barred by the applicable statute of limitations or that some of state causes of action are procedurally barred. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. 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 434. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. Mr. Specifically, in his sales representative training, he alleges that he was taught that there was a 2:1 equianalgesic ratio between OxyContin and MS Contin, a rival pain medication containing morphine, making OxyContin twice as potent and, as a result, cheaper per dose than MS Contin. (Mem. In 2010, his wife Angela and former underling May filed their own FCA lawsuit. 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. 2d 1158, 1164-65 (N.D. Ill. 2007). 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. United States ex rel. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). Certain sealed material has been redacted from the publicly released copy of this opinion. at 1512. 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. 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, at 1047. See United States v. Purdue Frederick Co., 495 F. 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. 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. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. That agency investigated and concluded that it could not substantiate the allegations. Purdue cites United States ex rel. 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. 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, Radcliffe was asked about the marketing of OxyContin as it related to the potential for addiction, but he was not asked about the relative cost and potency issue. 40 F.3d at 1510. Beginning in 2002 and continuing for the next several years, the government sought millions of documents from Purdue and conducted hundreds of interviews, some of which pertained to the relative potency and cost of OxyContin and MS Contin. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. United States ex Noah Nathan v. Takeda Pharmaceuticals North America, Inc. 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. 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. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. Id. 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]. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. No list was kept of the documents reviewed or flagged, but according to the declaration of one of Purdue's outside counsel these included documents about the dispute over the relative potency of OxyContin and MS Contin. United States District Court, W.D. 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. Months later, the former employee filed a qui tam complaint in federal court. CV202-189, 2005 WL 3741538, at *5 (S.D. Gebert v. Transp. 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 . Will be used in accordance with our terms of service & privacy policy. 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. Defs.' However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. Id. Id. The Fourth Circuit agreed that the district court did not have jurisdiction over the claims and affirmed. 104 F.3d at 231. Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. Purdue Pharma Br. 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. Congress deemed this necessary because of reluctance on the part of insiders to come forward with relevant knowledge of fraud as well as federal enforcement agencies' relative lack of resources to investigate and prosecute allegations of fraud, leaving some potentially significant cases unaddressed. Va. 2014) case opinion from the Southern District of West Virginia US Federal District Court . 481 F. Supp. 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." at 1277-78. All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. Servs., 260 F.3d 909, 916 (8th Cir. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. The Ninth Circuit determined that enforcement of the release would impair the public interest by diluting incentives to file qui tam suits, thus making the government less likely to learn of the alleged fraud, and by diluting the FCA's deterrent affect. 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."). 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. On August 1, 2005, Radcliffe executed a general release as part of . BECKLEY, W.Va. (Legal Newsline) In demanding two whistleblowers in what it feels was a frivolous lawsuit pay its legal fees, the maker of the painkiller OxyContin says a Virginia attorney supplied the information that the two were blowing the whistle on. Id. C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. 582 F. Supp. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. Id. at 1513-14. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. 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 . Rabushka v. Crane Co., 40 F.3d 1509, 1512-14 (8th Cir. See DeCarlo, 937 F. Supp. Id. Mark Rad v. Purdue Pharma L.P., No. 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. 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.'" Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. Matsushita Elec. 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. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . 2d at 1272. Purdue Pharma's attorneys suspected that Radcliffe was behind those threats. 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. Hall involved an employer who had been accused of fraud on the government by an employee. During this period . Id. 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. 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. Id. United States ex rel. He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." 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. at 916. ( Id. at 963. 1996). But that is not sufficient to meet the rigorous standard of Rule 9(b). Likewise, the public interest in using qui tam suits to supplement federal enforcement of the FCA was not disturbed as the government had already investigated the allegations prior to the release. 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.. After the present qui tam suit was stayed, the government's investigation continued. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. at 231-32. U.S. ex Rel. 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 at 774. The plea agreements included settlement of certain of the government's civil claims, but not of Radcliffe's qui tam suit. On August 1, 2005, he signed a severance agreement, which included a general release of all claims against Purdue. Radcliffe signed a general release of all claims against Purdue in exchange for an enhanced severance package. 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. He attached to the complaint at least one document already in the government's possession: an "Answer Guide" used to train sales representatives, which urged them to emphasize OxyContin's higher potency and lower cost compared to MS Contin. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. 434. Id. 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. 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). United States of America, et al. Dismiss, Exs. (c).) F. Brian Ferguson. The general release executed by Radcliffe does not bar this action. 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). 1999); Rabushka, 40 F.3d at 1514. Purdue Pharma L. P. et al, No. ex rel. 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." Id. In mid-July 2005 the government reviewed and flagged numerous documents in the possession of four Purdue employees, [Redacted]. and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." 1994). 2d 766, 774 (W.D. For convenience, references herein to the "Complaint" shall include the most recent version. Id. Mark RADCLIFFE, Plaintiffs, v. PURDUE, Court:United States District Court, W.D. United States ex rel.