at 963. 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. Va. 2007) (accepting plea agreements). Partial knowledge or investigation on the part of the government is insufficient to remove a case from the purview of Green into the exception created by Hall. Id. at 1043-46. Therapeutics 130 [Abstract PI-4] (1996); G.B. Redactions are denoted in brackets. McLean v. County of Santa Clara, No. 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. 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 . Id. 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). 2548, 91 L.Ed.2d 265 (1986). Defs.' 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. In this case, that information was the first FCA suit filed by Mark Radcliffe. 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. The package insert is currently posted to a section of Purdue's web page devoted to package inserts. 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. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. . 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. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. 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. 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. However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. 1999). Green, 59 F.3d at 962 (quoting Rumery, 480 U.S. at 392), 107 S.Ct. . As the release involved a statutorily-conferred federal right, the Ninth Circuit turned to federal common law to fill this "gap" in the statutory scheme. 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.'" (Mountcastle Decl. Id. In mid-July 2005 the government reviewed and flagged numerous documents in the possession of four Purdue employees, [Redacted]. Admin. Further, because parties engaged in the fraud would be able to settle their claims with potential relators for significantly less than they would once the government became aware of the allegations, the FCA's deterrent effect is also lessened. and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." This is factually distinct from the situation in which the government is in the midst of an ongoing investigation. However, he states that no details of the alleged misconduct were given and the attorney did not identify the name of his client. Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. After the qui tam suit was initiated, the NRC revisited its prior investigation and reached the same conclusions. 1996). 1039, 1043-47 (S.D.N.Y. 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. Hall, 104 F.3d at 231. I am troubled by the fact that Radcliffe's behavior, in waiting until the Department of Justice had already begun a criminal investigation into other allegations of marketing fraud committed by Purdue, before filing his qui tam action, suggests that he is an opportunistic relator. 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. Although the 2001 posting of the OxyContin package insert could be considered either a corporate report or a press release, because it was posted on a web page entitled "News What's New" and because other items on the page resemble press releases, I will consider the OxyContin package insert a public disclosure in the news media. Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. He alleged a fraudulent scheme whereby Purdue marketed 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). at 1047. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). The two are represented by the same two attorneys who represented Mark Hurt and Roop. 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. Yannacopolous v. General Dynamics, 315 F. Supp. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. After the action was filed, the United States investigated the qui tam relator's allegations, but ultimately chose not to intervene. All of the issues are now ripe for decision and will be discussed sertiam. 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. Green, 59 F.3d at 962 (quoting Davies, 930 F.2d at 1396). Id. Longhi v. Lithium Power Techs., Inc., 481 F. Supp. See id. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. Id. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. 481 F. Supp. 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. One of their attorneys is Mark 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. Purdue Pharma L.P., et al., Civil Action Nos. Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. If so, was the qui tam action based on the public disclosure? Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. 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. at 960. Instead of the 2:1 ratio Purdue Pharma claimed, the actual ratio was more like 1.5:1, the whistleblowers said. All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." For convenience, references herein to the "Complaint" shall include the most recent version. (Information 20, United States v. Purdue Frederick Co., No. Nathan v. Takeda Pharmaceuticals N.A. 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. 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. 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. 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". Auth. 49.7 (Patrick D. Wall Ronald Mezack eds. J.A. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. 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. Whitten v. Triad Hosps., Inc., No. Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. However, it is also clear from the evidence that the government continued to seek such information after the release had been executed on August 1, 2005. Purdue Pharma L.P., No. However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. at 962-63 (quoting Davies, 930 F.2d at 1399). regarding the relative potency of oxycodone." United States ex rel. 763 (E.D. He later retracted that offer after being informed by a lawyer that he could not settle a qui tam suit. 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. 458 (S.D.N.Y. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). 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. 2d 939, 949 (N.D. Ill. 2004), which held that newspaper articles published in Greek in the Greek press did not constitute disclosures to the American public. The Fourth Circuit does not have any analogous case law interpreting Rumery. 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. 434. BECKLEY, W.Va. - A Raleigh County man was sentenced today to five years in federal prison and ordered to pay a $25,000 fine for a witness tampering crime, announced United States Attorney Carol Casto. 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. & Training Trust Fund. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . 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]. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. of Pittsburgh, 186 F.3d 376, 385 (3d Cir. They say it is a reflection on the decline of civility in the legal profession. Bahrani v. Conagra, Inc., 183 F. Supp. . L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. Purdue Pharma, L.P. (1:05-cv-00089) District Court, W.D. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. Modification of these search terms occurred in December, 2005. U.S. ex Rel. See DeCarlo, 937 F. Supp. at 963. 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. In the conclusion of the response, the attorneys say Purdues allegations of bad faith and its personal attack on them are a lamentable tactic used to get an advantage in litigation. This 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. 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. 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 three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. 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. 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. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. That agency investigated and concluded that it could not substantiate the allegations. 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 . 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. Likewise, the prior public disclosures reveal that there was contradicting scientific evidence as to the relative potency of OxyContin to MS Contin, but they do not imply fraud. (Mountcastle Decl. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. 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. The plaintiff-relator, Mark Radcliffe ("Radcliffe"), filed a qui tam suit in the United States District Court for the West-ern District of Virginia alleging that his former employer, Purdue Pharma, L.P. ("Purdue"), defrauded the government . Purdue contends that, under Hall, enforcement of a release to bar a subsequent qui tam action is appropriate even if the government has not completed its investigation. 1:07-CR-00029 (W.D. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319, 321-22 (4th Cir. Id. See Fed.R.Civ.P. App. Dismiss 35.) But see United States ex rel. at 821. 2010). decision in United States ex rel. During this time the government was conducting a criminal investigation of Purdue's marketing of OxyContin, eventually resulting in guilty pleas in this court by a related company and three of Purdue's top executives. Matsushita, 475 U.S. at 587, 106 S.Ct. (quoting 5 Charles Alan Wright Arthur R. Miller, Federal Practice and Procedure 1297, at 590 (2d ed. See United States v. Purdue Frederick Co., 495 F. Supp. Id. In this qui tam action, the defendants have moved to dismiss on several grounds, including the jurisdictional bar based on prior public disclosures of the alleged false claims, the execution of a pre-filing general release by the relator, and a failure to plead fraud with particularity under Rule 9(b). at 1278. Id. 2d 766, 774 (W.D. 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. Kennedy v. Aventis Pharms., Inc., 512 F. Supp. Wilson, 528 F.3d at 299. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. at 818. Id. Section 3730(e)(4)(A) provides an exclusive list of sources that may give rise to a public disclosure that will strip a court of subject matter jurisdiction: "disclosures in (1) criminal, civil, or administrative hearings; (2) congressional, administrative, or Government [Accountability] Office reports, hearings, audits, or investigations; and (3) the news media." Disclosures made in other public forums do not implicate the public disclosure bar. 1994). Mr. When he raised the issue his supervisor assured him that the 2:1 ratio was correct. to Mot. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. Id. 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. I think it is sufficient under Hall that the government know of the substance of the allegations. 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. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. 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. Regardless, the 1996 abstract was published in Clinical Pharmacology Therapeutics, a scientific journal headquartered in Alexandria, Virginia. While the prior public disclosures included information that was true, they did not reveal the "true" state of facts regarding the executives' knowledge or intentions. 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. Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 784 n. 5 (4th Cir. Pharmacol. Because the public disclosure bar involves the jurisdiction of the court, it must be determined first, before proceeding to any other questions. The parties have been provided with the sealed copy. [2] 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. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. 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. 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. However, neither case discusses the policy implications of enforcing a release in the context of the FCA. at 963-64. 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. 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. at 1513. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. 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.'" Radcliffe also avers that. Will be used in accordance with our terms of service & privacy policy. J.A. Purdue Pharma is represented by John Hoblitzell III and Rebecca Betts of Kay Casto & Chaney in Charleston, W.Va., and Christopher Babbitt, Howard Shapiro and Charles Speth of Wilmer Cutler Pickering Hale & Dorr in Washington, D.C. On Oct. 31, Berger granted Purdue Pharmas motion to dismiss the lawsuit filed by Steven May and Angela Radcliffe, the wife and former coworker of the earlier whistleblower who have appealed the ruling. 1999); Rabushka, 40 F.3d at 1514. 2006). To meet this requirement, it is sufficient that there have been either (1) disclosures of both a false state of facts and a true state of facts (not necessarily from the same source) so that fraud is implied; or (2) disclosure of an allegation of fraud, regardless of the specificity of the allegation. Because of the potential in this area for state law to impair federal rights, the possibility of forum-shopping, and the unlikeness that uniform federal rule would disrupt commercial relationships predicated on state law, the Ninth Circuit chose to craft a uniform federal rule, rather than apply state law. Months later, the former employee filed a qui tam complaint in federal court. 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. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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. United States ex rel. United States ex rel. The facts surrounding this defense have been developed in the summary judgment record. 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." I agree. Dismiss 20.) 30.) Indus. 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. 104 F.3d at 231. Id. He was not asked about the relative cost or potency of OxyContin and MS Contin, nor was he asked about the equianalgesic ratio of these two drugs. Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). 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. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. at 233. 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. Despite the labeling of the 2001 page, I find that this is not analogous to a traditional news outlet or periodical or even a trade journal because it involves information disseminated by one company about its own products, rather than a news organization or industry group disseminating information of general or specialized interest. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. 14-2299 (4th Cir. MEMORANDUM OPINION AND ORDER R. CLARKE VanDERVORT Magistrate Judge. Purdue has withdraw that argument, including its related Request for Judicial Notice. (Defs.' For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. 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.'" Dismiss, Exs. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians. 1971), and Coleson v. Inspector General of the Department of Defense, 721 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. Mot. Servs., 260 F.3d 909, 916 (8th Cir. 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. 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. 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L.Ed.2D 538 ( 1986 ) ( quotations and citations omitted ) was issued commanding Radcliffe to appear the! September 27, 2005 so, was the first FCA suit filed by Mark Radcliffe subpoena was commanding. The Complaint and potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55.... 'S execution of the general release on August 2, 2005 ) ( quotations and omitted... Required by Federal Rule of Civil Procedure 9 ( b ) section of Purdue web. Relator 's allegations pertain to the party opposing the motion to dismiss the Relators & # x27 Complaint... 1971 ), and Coleson v. Inspector general of the 2:1 ratio Purdue Pharma L.P. 600. Included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking mark radcliffe purdue pharma physicians ] ( ). Ongoing investigation actual ratio was correct issues are now ripe for decision will! 507 F.3d 720, 733 ( 1st Cir 176 F.3d 776, 784 n. 5 ( 4th Cir currently., I find no cognizable basis for denying Radcliffe 's request search terms occurred December.
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