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Wilson, 528 F.3d at 299. Mark Rad v. Purdue Pharma L.P. Filing 920100324 Download PDF . The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. (Defs.' Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. The Newsletter Bringing the Legal System to Light. 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 Id. 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. 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. at 963-64. 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. Id. However, the decision to enforce the release turned on the fact that the release occurred "in the context of a bankruptcy proceeding, not through a general, independent release of a claim for money." 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. 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." decision in United States ex rel. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. On August 1, 2005, he signed a severance agreement, which included a general release of all claims against Purdue. 1999). Supp. Id. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. Regardless, the 1996 abstract was published in Clinical Pharmacology Therapeutics, a scientific journal headquartered in Alexandria, Virginia. Defs.' Gilligan v. Medtronic, Inc., 403 F.3d 386, 389 (6th Cir. Wilson, 528 F.3d at 300-01 (alternations and internal quotations omitted); see Eberhardt v. Integrated Design Constr., Inc., 167 F.3d 861, 870 (4th Cir. 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. (c) and (f)(2)). 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.'" In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. Unsealing the Complaint or allowing the suit to proceed would make a portion of the grand jury's pending investigation public. Specifically, he alleged that Purdue fraudulently marketed OxyContin using the 2:1 equianalgesic ratio, thus claiming that its relative cost was less than that of MS Contin. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. (c).) (Reply Supp. The facts surrounding this defense have been developed in the summary judgment record. The court did not inquire into the fullness of the government's investigation. It is unclear from Hall whether the NRC was made aware of the identity of the specific person making the allegations when it first investigated the matter. Because I find that these scientific articles and the OxyContin package insert, taken together, do not disclose or imply fraud, and, thus, do not constitute a public disclosure of the allegations or transactions within the meaning of 3730(e)(4)(A), I need not address the extent to which Radcliffe based his allegations on these materials, nor whether he was an original source. Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. 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. As early as 1996, Radcliffe found that some of the physicians he spoke to were skeptical of this 2:1 ratio. United States ex rel. 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. Springfield Terminal Ry. (Mountcastle Decl. 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. 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. 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. 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. 9 n.4. But that is not sufficient to meet the rigorous standard of Rule 9(b). See Fed.R.Civ.P. On August 1, 2005, Radcliffe executed a general release as part of . Green v. Serv. 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. Whitten v. Triad Hosps., Inc., No. But see United States ex rel. In these somewhat rambling and incoherent emails, he warned Purdue that he was considering a qui tam suit, detailed his allegations, and offered to settle in exchange for an investment by Purdue in a project he was contemplating. Id. Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. 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." Defs.' CIV.A. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. After carefully considering the arguments of the parties, I hold that the Complaint does not adequately state a claim for fraud under Rule 9(b). 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. Wilson v. Graham County Soil Water Conservation Dist., 528 F.3d 292, 309 (4th Cir. See id. 104 F.3d at 231. 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. Id. 434. These disclosures suggest legitimate scientific debate and disagreement regarding the correct equianalgesic ratio, rather than any fraudulent intent on the part of Purdue. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. The allegations claimed Purdue Pharma marketed OxyContin with a false claim that a patient could use half as much OxyContin as MS Contin to treat the same pain. 2548, 91 L.Ed.2d 265 (1986). 763 (E.D. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. 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. 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. Id. When he raised the issue his supervisor assured him that the 2:1 ratio was correct. Id. 582 F. Supp. 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. Pharmacol. 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. the baton" and file the qui tam action against Purdue now before the court. While the results of this study were not published until 1999, an abstract including the 2:1 equianalgesic ratio was published in 1996. 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 motion says the whistleblowers attorney, Hurt, knewthe two would take up the baton after the first FCA suit was dismissed and that the two did not have personal knowledge of the allegations of fraud they would make against Purdue, claiming they even contradicted the claims made in the complaint during their testimony. Both were published in scientific periodicals. 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.. at 820. Id. By the end of July, the government had also begun drafting Grand Jury Subpoena 513 which included requests for all documents discussing the relative analgesic potency or safety of OxyContin and MS Contin. Indeed, Mr. Hurt drafted the core allegations not on the basis of information and facts relayed to him by Relators, but rather by using information and documents provided to him by Mark Radcliffe (the plaintiff in the first, unsuccessful case), the motion says. Therapeutics 130 [Abstract PI-4] (1996); G.B. The Fourth Circuit does not have any analogous case law interpreting Rumery. 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. 2d 766, 774 (W.D. The Fourth Circuit agreed that the district court did not have jurisdiction over the claims and affirmed. 2d 815, 818 (S.D. Bahrani, 183 F. Supp. Id. of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. . J.A. Id. Purdue Pharma L.P., et al., Civil Action Nos. and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. Purdue Pharma Br. Redactions are denoted in brackets. 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. ( Id. However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. 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". Mark Rad v. Purdue Pharma L.P. Filing 920100324. . Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. at 962-63 (quoting Davies, 930 F.2d at 1399). In his Complaint, Radcliffe references, but does not cite, a single-dose potency study that his supervisors told him supported an equianalgesic ratio of 2:1. 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. This is factually distinct from the situation in which the government is in the midst of an ongoing investigation. Disclosures made in other public forums do not implicate the public disclosure bar. Purdue urges the court to consider pre- Green cases Virginia Impression Products Co. v. SCM Corp., 448 F.2d 262 (4th Cir. at 916. F. Brian Ferguson. 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. Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. If anything on the record suggests fraud with respect to the relative cost and potency, it is the relator's statements regarding his experiences in being trained to market OxyContin and his questioning of his supervisors about the relative potency issue, as well as the internal training materials that explained how to address the relative cost issue with physicians. If so, was the qui tam action based on the public disclosure? 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. 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. 1994). Dismiss, Exs. 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. Virginia, Abingdon Division. Pharmacol. Va. 2014) case opinion from the Southern District of West Virginia US Federal District Court . 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. . 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. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. Id. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). 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." Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . Id. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: Kennedy v. Aventis Pharms., Inc., 512 F. Supp. 2d at 774. In September, the Department of Justice contacted Purdue's outside counsel with electronic search terms designed to capture documents [Redacted]. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. Nathan v. Takeda Pharmaceuticals N.A. 481 F. Supp. The general release executed by Radcliffe does not bar this action. DeCarlo v. Kiewit/AFC Enters., Inc., 937 F. Supp. 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. 40 F.3d at 1510. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. Purdue's response was ambiguous, first stating that Radcliffe did not have legitimate claim, but if he thought he did he should make it, then expressing an interest in investing in Radcliffe's company. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 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. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. 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. during the depositions of Mark and Angela Radcliffe and Steven May respecting commu nications between Relators and Mark Radcliffe and Relators and their attorneys with Mark . Relators, or private individuals who bring suits on behalf of the government, are entitled to a portion of the recovery from a qui tam suit, the amount of which depends on whether the government chooses to intervene after learning the allegations and prosecute the case itself and the overall importance of the relator's participation in the action. Because the public disclosure bar involves the jurisdiction of the court, it must be determined first, before proceeding to any other questions. While allegations of fraud were known to the Department of Justice, they had not been publically disclosed within the meaning of 3730(e)(4)(A). However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. The court found no statutory or policy reasons to prevent enforcement of the release. While the 1999 article was published in European Journal of Clinical Pharmacology, it was authored by scientists in the United States and written in the English language. 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. the baton" and file the qui tam action against Purdue now before the court. 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 . 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d 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.'" 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. 14-2299 (4th Cir. 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). Will be used in accordance with our terms of service & privacy policy. 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 . 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. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . 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. 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. Bahrani, 183 F. Supp. Bell Tel. After all, they were suing Purdue, not for any injuries that they had personally suffered, but for Purdues fraud against the Government, a response filed Dec. 4 says.

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