mark radcliffe purdue pharma

The two are represented by the same two attorneys who represented Mark Hurt and Roop. One of their attorneys is Mark ), aff'd, 53 F. App'x 153 (2d Cir. I think it is sufficient under Hall that the government know of the substance of the allegations. 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit 31 U.S.C.A. 2007). at 1512. Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). In his job marketing OxyContin to physicians, the relator Radcliffe became familiar with claims made by Purdue about the medication's relative cost and potency. Auth. 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 MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. 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. 2d 815, 818 (S.D. at 817. On September 18 2014 Defendants hereinafter Purdue filed.20141009i18 The Fourth Circuit follows a three-step approach in determining whether the public disclosure bar applies. The plaintiff has the burden of showing that the court has subject matter jurisdiction. 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. If so, was the qui tam action based on the public disclosure? Further, such a rule would mean that the enforceability of the release would be uncertain until such time as the government chose whether to intervene, which would undermine the countervailing interest in settlement of litigation. 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. Certain sealed material has been redacted from the publicly released copy of this opinion. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. 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." It further states that OxyContin is "indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time." Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. 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. 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. Purdue Pharma L.P., No. ( Id. 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. 2005); see Springfield, 14 F.3d at 655. of Pittsburgh, 186 F.3d 376, 385 (3d Cir. the baton" and file the qui tam action against Purdue now before the court. The Fourth Circuit does not have any analogous case law interpreting Rumery. Mot. United States ex rel. 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. 1990)). the baton" and file the qui tam action against Purdue now before the court. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. at 1047. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . Wilson, 528 F.3d at 299. However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. 1994) ("Textbook of Pain"). 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. 09-1202 (4th Cir. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. That agency investigated and concluded that it could not substantiate the allegations. See id. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. 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. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. Id. 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. Purdue urges the court to consider pre- Green cases Virginia Impression Products Co. v. SCM Corp., 448 F.2d 262 (4th Cir. . and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." He alleged a fraudulent scheme whereby Purdue marketed However, he states that no details of the alleged misconduct were given and the attorney did not identify the name of his client. 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." 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. 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. 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. 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. 5:2010cv01423 - Document 191 (S.D.W. For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. 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. Ramseyer recalls receiving a telephone call from a West Virginia attorney regarding a possible qui tam suit against Purdue at some point prior to September 27, 2005. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. Because the public disclosure bar involves the jurisdiction of the court, it must be determined first, before proceeding to any other questions. 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. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. 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. 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. ex rel. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. Nathan v. Takeda Pharmaceuticals N.A. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. 2010). One of their attorneys is Mark 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]. The package insert is currently posted to a section of Purdue's web page devoted to package inserts. 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. 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. In January and February of 2005 Radcliffe sent emails to several officers and directors of Purdue, using the alias "John Femaledeer." 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. Given the international nature of the scientific community, there is no indication that the publication of this article in a foreign scientific journal makes it any less accessible to the American public than if it were published in a scientific journal located in the United States. Id. 1994). 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. 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 . For instance, this web page could be affiliated with a news publication and, as such, would be updated regularly and would disseminate information to the public in a periodic manner. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . 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, The citations it relies on to support this argument are inapposite or misleading. 2548, 91 L.Ed.2d 265 (1986). 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. Purdue Pharma L.P., et al., Civil Action Nos. However, I believe that enforcing the release under these circumstances would substantially impact important public interests associated with the FCA. Further, the public policy concerns raised by Purdue do not alter the relative balance of public interests under the Rumery test. 1348 (quoting Fed.R.Civ.P. 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." Va. 2008). (Mountcastle Decl. 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. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. at 966. Id. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. Hall involved an employer who had been accused of fraud on the government by an employee. 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. Va. 2007) (accepting plea agreements). at 962-63 (quoting Davies, 930 F.2d at 1399). The court found no statutory or policy reasons to prevent enforcement of the release. Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. Gebert v. Transp. (f)(2).) Id. 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. The three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. Id. Id. 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. Purdue Pharma's attorneys suspected that Radcliffe was behind those threats. at 1278. 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. 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. . Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. It is not entirely obvious why the Ninth Circuit concluded that a full investigation negates the public interest in having a qui tam supplement federal enforcement, which includes not only disclosing information to the government, but also potentially investigating and prosecuting the case on behalf of the government. 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. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: 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 . 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. 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.'" 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. 1995), and United States ex rel Hall v. Teledyne Wah Chang Albany, 104 F.3d 230 (9th Cir. Several of these physicians directed Radcliffe to specific sources in the scientific literature to show that the correct equianalgesic ratio between MS Contin and OxyContin was closer to 1:1, meaning that OxyContin was less potent and more expensive than Purdue claimed. Green, 59 F.3d at 959. 104 F.3d at 231. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. Id. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. Id. They say it is a reflection on the decline of civility in the legal profession. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. 3730(e)(4)(A); see United States ex rel. Decided: January 29, 2016. 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. 1993) (quotations and citations omitted). 1:07-CR-00029 (W.D. Defs.' Unsealing the Complaint or allowing the suit to proceed would make a portion of the grand jury's pending investigation public. 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. at 965-66. In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. United States District Court, W.D. 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. 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." 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 United States ex rel. 1996). The FCA provides that there is no subject matter jurisdiction in a case where the claim is. 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). 763 (E.D. 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. 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 969. 1999). Enforcement of a release to bar a subsequent qui tam suit implicates several articulated public interests. The Newsletter Bringing the Legal System to Light. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. 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. 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". 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 Radcliffea former district sales manager for Purdue Pharma ("Purdue")filed a qui tam action under the FCA against Purdue. at 956-57. 2d at 774. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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. 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. Bell Tel. CV202-189, 2005 WL 3741538, at *5 (S.D. 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. 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. United States ex rel. The facts surrounding this defense have been developed in the summary judgment record. 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 . 2d 766, 774 (W.D. C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. It was dismissed for failure to plead fraud with sufficient particularity. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. Id. 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. Id. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 2d. Mark Radcliffe, 59, of Shady Spring, was convicted following a three-day jury trial. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. 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. Instead of the 2:1 ratio Purdue Pharma claimed, the actual ratio was more like 1.5:1, the whistleblowers said. Although antitrust cases are similar to qui tam suits in that the government relies on the enforcement efforts of private parties, the policy implications and economic incentives differ. Id. 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. (Mountcastle Decl. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. 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. At 965-68 ; Bahrani, 183 F. Supp 385 ( 3d Cir anything posted online would automaticallyconstitute public... And United States ex rel ; and file the qui tam action against Purdue in the legal profession the! Web site pre- Green cases Virginia Impression Products Co. v. Zenith Radio Corp., 448 F.2d 262 ( 4th.... The evidence submitted during their grand jury appearances on July 20, 2005, a subpoena was commanding! 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