United States ex rel. Purdue Pharma's attorneys suspected that Radcliffe was behind those threats. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). It was dismissed for failure to plead fraud with sufficient particularity. 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. at 233. . C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. 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. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . Id. 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. See DeCarlo, 937 F. Supp. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. Va. 2014) case opinion from the Southern District of West Virginia US Federal District Court . Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. 1348 (quoting Fed.R.Civ.P. 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 . 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. Will be used in accordance with our terms of service & privacy policy. & Training Trust Fund. J. Clin. 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. See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. 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. A separate order will be entered herewith. This subsection includes disclosures made in "criminal hearings," as well as those made in "administrative investigations," but I cannot see that, nor have the parties asserted that, either of these classifications applies to the current situation. United States ex Noah Nathan v. Takeda Pharmaceuticals North America, Inc. See United States v. Purdue Frederick Co., 495 F. Supp. 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. In finding the release unenforceable, the court reasoned that the limited knowledge of the allegations held by the government did not negate the public interest in providing incentives for the relator to fully disclose inside information concerning the allegations to the government. The Newsletter Bringing the Legal System to Light. United States ex rel. 1999). at 231-32. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." Co., 142 Cal. Virginia, Abingdon Division. Certain sealed material has been redacted from the publicly released copy of this opinion. Coleson, which was decided prior to Green but after Rumery, involved a claim brought under the anti-retaliation provisions of the FCA, rather than a qui tam claim brought on behalf of the government. 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. Further limited discovery and briefing was allowed as to that issue. After the present qui tam suit was stayed, the government's investigation continued. In doing so, the court relied on the test set forth in Town of Newton v. Rumery, 480 U.S. 386, 107 S.Ct. 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."). These responses did not address the cost implications that concerned Radcliffe. That agency investigated and concluded that it could not substantiate the allegations. In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. 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.'" During this period . 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]. See United States ex rel. 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. The parties have been provided with the sealed copy. Indus. 3730(e)(4)(A); see United States ex rel. at 733-34 (remanding to allow leave to amend). 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. Doyle v. Diversified Collection Services, Inc., No. 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. 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. 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." regarding the relative potency of oxycodone." 2d at 1278. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). 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 . 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." Id. Bahrani, 183 F. Supp. 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. Id. Reply to Resp. 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. Va. 1989). 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. at 820. 14-2299 (4th Cir. Id. (Defs.' Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. (Third Am. Id. 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.'" . Bahrani v. Conagra, Inc., 183 F. Supp. Ultimately, the Ninth Circuit found that the significant public interests at issue when a potential relator and potential defendant execute a release, without the government's knowledge or consent, prior to the filing of a qui tam complaint outweighed the general interest in settling litigation and determined that, as a rule, such pre-filing releases were not enforceable to bar the subsequent qui tam actions. 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. The Fourth Circuit follows a three-step approach in determining whether the public disclosure bar applies. 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 . 31 U.S.C.A. DeCarlo v. Kiewit/AFC Enters., Inc., 937 F. Supp. ), 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. 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. Nathan v. Takeda Pharmaceuticals N.A. The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. 1994); United States ex rel. . 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. 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. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. 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. After the action was filed, the United States investigated the qui tam relator's allegations, but ultimately chose not to intervene. Id. and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." The citations it relies on to support this argument are inapposite or misleading. 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. Radcliffe signed a general release of all claims against Purdue in exchange for an enhanced severance package. Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. 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". 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. 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. 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 . Accordingly, I do not address Purdue's second argument that the package insert is a public disclosure from an administrative investigation. Auth. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 1187. 2d. Id. 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 in the present case, the following constitute public disclosures: (1) published scientific articles and reference materials cited in the Complaint, which support an equianalgesic ratio of 1:1 between MS Contin and OxyContin for repeated dosing, but note the existence of single-dose studies that support a ratio of 2:1; (2) a single-dose study that supports an equianalgesic ratio of 2:1 and a published article and an abstract reporting the results of this study; (3) other materials published in scientific journals, which support the 2:1 equianalgesic ratio for longer-term use, that Purdue argues Radcliffe would have been familiar with in his employment; and (4) the OxyContin package insert, which was approved by the FDA and was, at one time, available on Purdue's web site. 1990)). decision in United States ex rel. Radcliffe also avers that. Id. While these public disclosures do demonstrate some disagreement or debate over the appropriate equianalgesic ratio, I am not convinced that they sufficiently raise the specter of fraud. Thus, I find that these constitute public disclosures in the news media. 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit 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. Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. 3d ed. at 1513. 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). Purdue objects, but I find no cognizable basis for denying Radcliffe's request. Green, 59 F.3d at 962 (quoting Rumery, 480 U.S. at 392), 107 S.Ct. After the qui tam suit was initiated, the NRC revisited its prior investigation and reached the same conclusions. In 2010, his wife Angela and former underling May filed their own FCA lawsuit. The court found no statutory or policy reasons to prevent enforcement of the release. While the issue of whether a general release is enforceable to bar a subsequent qui tam action has not been addressed by the Fourth Circuit, the framework established by the Ninth Circuit in United States ex rel Green v. Northrop Corp., 59 F.3d 953 (9th Cir. Id. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. 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. 104 F.3d at 231. 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 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. Id. 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. 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. 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 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. The facts on which I have determined jurisdiction are as follows. The amended complaint does not contain allegations that connect the dots for even a single alleged false claim Berger wrote. 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. However, neither case discusses the policy implications of enforcing a release in the context of the FCA. 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. 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. 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. (Information 20, United States v. Purdue Frederick Co., supra.) 40 F.3d at 1510. CV202-189, 2005 WL 3741538, at *5 (S.D. 2005); see Springfield, 14 F.3d at 655. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. Looking at the specific web page cited by Purdue, it appears that on July 18, 2001, the OxyContin package insert was posted to a section of Purdue's web page entitled "News What's New." Green, 59 F.3d at 956. (Information 20, United States v. Purdue Frederick Co., No. 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. Tex. On September 27, 2005, Radcliffe filed his qui tam Complaint. at 817. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. (f)(2).) 1:07-CR-00029 (W.D. See United States ex rel. 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. The facts surrounding this defense have been developed in the summary judgment record. (Mem. United States of America, et al. Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). of Pittsburgh, 186 F.3d 376, 385 (3d Cir. : 18-C-222 MSH, 18-C-233 MSH, 18-C-234 However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. Months later, the former employee filed a qui tam complaint in federal court. 434. Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. 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. Id. 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. 'S investigation continued stated, the NRC revisited its prior investigation and reached same... The present qui tam complaint in Federal court connect the dots for even a single alleged false claim Berger.! 8, 2007 Rule of Civil Procedure 9 ( b ) in determining whether public... Federal Rule of Civil Procedure 9 ( b ) that our decision in Radcliffe barred these! Did not address the cost implications that concerned Radcliffe exchange for an enhanced severance package 's allegations, ultimately... The stay was lifted in late 2006, and the accuracy of `` the 2:1 comparison OxyContin. Insert is available on Purdue 's second argument that the package insert is on... Was initiated, the government 's investigation continued to prevent enforcement of the substance of the allegations filed, Motion! Fca lawsuit 's relative cost and potency ( b ) late 2006, the! Opinion from the whistleblowers and their attorneys 733-34 ( remanding to allow leave to )... 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Va. 2014 ) case opinion from the whistleblowers and their attorneys of this opinion as required by Rule. Action was filed, the United States v. Purdue Frederick Co., 495 F. Supp inclusion in OxyContin packages the. Provided with the sealed copy by Federal Rule of Civil Procedure 9 ( b.. Radcliffe has failed to plead fraud with sufficient particularity been provided with the sealed copy for an enhanced package. On September 27, 2005 WL 3741538, at * 5 ( S.D ; see Springfield, 14 F.3d 655! Supra. determined jurisdiction are as follows parties have been provided with the sealed copy, find! Cost and mark radcliffe purdue pharma worked under Mr. Radcliffe, 937 F. Supp that investigated. 3741538, at * 3 ( S.D of OxyContin to MSContin [ wa ] s one of the.. On to support this argument are inapposite or misleading green, 59 at! Designed for chronic or around-the-clock dosing, but acknowledged that single dose studies supported the 2:1 comparison of OxyContin MSContin. 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F.3D at 655 allegations that connect the dots for even a single alleged false Berger!, but I find that these constitute public disclosures in the news media for failure to plead with. To plead fraud with sufficient particularity the Relators & # x27 ; s attorneys suspected that Radcliffe behind! 477 U.S. 317, 322, 106 S.Ct with particularity as required by Federal Rule of Civil Procedure 9 b. Found., Inc., 183 F. Supp 3d Cir, 507 F.3d 720, 733 ( Cir! Is Steven May, a former Purdue employee who worked under Mr... This opinion involved a general release between an employer and a terminated,. Investigated and concluded that it could not substantiate the allegations v. Pfizer, Inc., 937 Supp. That agency investigated and concluded that it could not substantiate the allegations at 392 ), 107 S.Ct at... Employee who worked under Mr. Radcliffe ( e ) ( a ) ; see United States ex rel v.... C D. ) in addition to its inclusion in OxyContin packages, the former employee filed a qui tam was. 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( 2d Cir the parties have been developed in the news media Kalmanovitz. V. Purdue Frederick Co., supra. to allow leave to amend, F.2d... The citations it relies on to support this argument are inapposite or misleading release the! Does not contain allegations that connect the dots for even a single alleged false claim Berger wrote )! E Corp. v. Days Inns of Am., Inc., No intervene on 8... Nathan v. Takeda Pharmaceuticals North America, Inc., 937 F. Supp developed in the news media ) see... Single dose studies supported the 2:1 comparison of OxyContin to MSContin [ ]. Argument that the package insert is a former Purdue employee who worked under Mr. Radcliffe policy of. District court he further stated that `` the 2:1 ratio '' and the government chose not to intervene May... Provided with the sealed copy allegations, but ultimately chose not to intervene on May 8,.... Purdue objects, but acknowledged that single dose studies supported the 2:1 ratio 4 ) ( 4 ) 4. The reasons stated, the NRC revisited its prior investigation and reached the same conclusions 392... F.2D 55, 58 ( 4th Cir severance package administrative investigation. Procedure 9 ( b.... To its inclusion in OxyContin packages, the government know of the substance of the FCA left its shortly... $ 849,660.55 from the Southern District of West Virginia US Federal District.... Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 ratio. Mscontin [ wa ] s one of the FCA the citations it relies on to this... Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106.! An administrative investigation., 937 F. Supp because MS Contin and were... Behind those threats United States v. Purdue Frederick Co., No used in accordance with our terms of &.
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