Also on July 28, the government issued a subpoena for Michael Cullen, [Redacted]; he was later asked during his grand jury testimony about the relative potency issue. On September 27, 2005, Radcliffe filed his qui tam Complaint. In responding to Purdue Pharmas allegations, the attorneys say the whistleblowers have always been upfront that their knowledge of the alleged scheme was second-hand. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: Mark Radcliffe v. Purdue Pharma L.P.; Purdue Pharma, Inc. 1 In a decision issued on March 24, 2010, the United States Court of Appeals for the Fourth Circuit concluded that a general release may bar a subsequent qui tam action if the allegations of fraud had been sufficiently disclosed to the government prior to the filing of the qui tam lawsuit. (c) and (f)(2)). Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . at 231-32. 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 . 2005); see Springfield, 14 F.3d at 655. With respect to the settlement attempts, it would seem counterintuitive to enforce a release to bar a subsequent qui tam suit, thus foreclosing the relator's ability to prosecute on behalf of the government, to punish that relator for trying to settle instead of filing suit in the first place. 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. But that is not sufficient to meet the rigorous standard of Rule 9(b). Id. 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. 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). Of course, it is plausible that a physician would be so induced by false representations concerning OxyContin's relative potency to write a prescription, ultimately paid for by the government. Decided: January 29, 2016. 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. After the present qui tam suit was stayed, the government's investigation continued. 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.'" Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). Dismiss 35.) United States ex rel. Auth. 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. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. He was also told that Purdue's decision to rely on the 2:1 ratio, despite published articles indicating that the 1:1 ratio was more appropriate for OxyContin's approved use, was based on safety concerns, that is, it was better for doctors to start with a lower dose and adjust upward if necessary. ex rel. J.A. See DeCarlo, 937 F. Supp. Id. See United States ex rel. ( Id. The court did not inquire into the fullness of the government's investigation. Purdue cites United States ex rel. Id. Dismiss 20.) 2001); United States ex rel. 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. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . 2006). 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. at 1512. decision in United States ex rel. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. The term "news media" includes scholarly, scientific, and technical periodicals, including trade journals, because, like newspapers, these sources disseminate information to the public in a periodic manner. The generalized interest in settling litigation is outweighed in the present circumstances by public interests that would be impaired by enforcement of this release, and so analysis under the Rumery test does not favor enforcing Radcliffe's release. 9 n.4. Supp. The Fourth Circuit does not have any analogous case law interpreting Rumery. 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. 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 . On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. United States of America, et al. 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. 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. 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, 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. (Mountcastle Decl. formerly a sales representative for Purdue under Mark Radcliffe's supervision. Purdue does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. 3730(e)(4)(A); see 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. Further limited discovery and briefing was allowed as to that issue. Va. 2008). 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."). The package insert recommends a starting conversion rate between OxyContin and MS Contin of 2:1, which can be reassessed based on a patient's reaction to the dosage. Treating all allegations as true, patients may have received less effective pain relief, but it is far from clear that the government paid more money.. Pharmacol. This is factually distinct from the situation in which the government is in the midst of an ongoing investigation. Tex. 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. DeCarlo, 937 F. Supp. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. The qui tam provisions are designed to supplement government enforcement of the FCA by using financial incentives to encourage insiders privy to fraud on the government to disclose this inside knowledge and potentially prosecute violations. 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. Relators claims had no objectively reasonable chance of success, the company argues. 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. When he raised the issue his supervisor assured him that the 2:1 ratio was correct. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . Finally, if the action was based on the public disclosure, was the relator an original source? Had the substance of the relator's allegations been disclosed to an appropriate employee at the FDA with the authority to investigate these claims, that might have constituted a disclosure in an administrative investigation. But see United States ex rel. 1996). 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. Virginia, Abingdon Division. the baton" and file the qui tam action against Purdue now before the court. 14-2299 (4th Cir. Id. C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. United States ex rel. Matsushita Elec. See United States v. Purdue Frederick Co., 495 F. Supp. Id. As to the defense that Radcliffe had released Purdue from the claims, I decided to treat the Motion to Dismiss as one for summary judgment in accord with Federal Rule of Civil Procedure 12(d). He alleged a fraudulent scheme whereby Purdue marketed at 965-66. 2007). 434. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. 2d. (Mountcastle Decl. 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. If a substantial public interest would be impaired, the court need not engage in the Rumery balancing test unless there is an articulated reason favoring enforcement aside from the "`interest in the settlement of litigation,'" as that "`cannot by itself outweigh a substantial public interest on the other side of the scales.'" It was dismissed for failure to plead fraud with sufficient particularity. Id. Hall involved an employer who had been accused of fraud on the government by an employee. If so, was the qui tam action based on the public disclosure? 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. Reply to Resp. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. Id. 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. 2d at 1278. 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. 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. 1:07-CR-00029 (W.D. 582 F. Supp. ), aff'd, 53 F. App'x 153 (2d Cir. Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. the baton" and file the qui tam action against Purdue now before the court. at 232. 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." Purdue Pharma L. P. et al, No. at 916. U.S. ex Rel. Here, it appears that the government did learn of the substance of Radcliffe's allegations independently and was interested enough in them to request documents pertaining to and question various Purdue employees about the relative cost and potency issue. The opinion makes no mention of what type of web page this is or whether it bears any resemblance to a traditional periodical. at 960. Id. Modification of these search terms occurred in December, 2005. 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.'" C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. 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 . 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. Springfield Terminal Ry. 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. Id. Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. One of their attorneys is Mark Enforcement of a release to bar a subsequent qui tam suit implicates several articulated public interests. Id. at 1513-14. The two attorneys claim in a response that Purdue Pharma has failed to meet its burden for showing that fee-shifting is appropriate and that the judge who dismissed the earlier lawsuit ruled at least part of the complaint passed muster, but it fell outside of a six-year statute of limitations period. 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. (Mem. 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 963. 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. For the purposes of addressing the public disclosure issue, the Complaint and the Third Amended Complaint contain the same claims and neither party has indicated that any relevant public disclosures were made between the date the Complaint was file and the date that the Third Amended Complaint was filed. 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. 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. 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. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. 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). 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." Will be used in accordance with our terms of service & privacy policy. (Mountcastle Decl. For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. 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 . 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 (Third Am. 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. Accordingly, I do not address Purdue's second argument that the package insert is a public disclosure from an administrative investigation. Id. One of their attorneys is Mark 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. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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 1512-13. On September 18 2014 Defendants hereinafter Purdue filed.20141009i18 Green, 59 F.3d at 962 (quoting Rumery, 480 U.S. at 392), 107 S.Ct. 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. I agree. On August 1, 2005, he signed a severance agreement, which included a general release of all claims against Purdue. Generally, this does not require that the disclosure be of the specific allegations brought by the relator, but instead the disclosure must put the government on notice of the likelihood of fraudulent activity. Government 's investigation, 14 F.3d at 655 tam suit implicates several public!, Beckley, WV, for Mark Radcliffe ) and ( f ) ( ). Claims against Purdue now before the grand jury ( f ) ( quotations and citations omitted ) relied the... And OxyContin were designed for chronic dosing, these create an implication of fraud on public! The execution of the release Radcliffe & # x27 ; Complaint on res judicata,. Not have any analogous case law interpreting Rumery because MS Contin and OxyContin designed. Appropriate one dismiss will be used in accordance with our terms of service & privacy policy at Purdue who! W. Roop, II, Beckley, WV, for Mark Radcliffe v. Kimbell Foods, Inc., U.S.! The fullness of the government is in the midst of an ongoing investigation WV for... Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 ( 2d.!, 14 F.3d at 655 addition to its inclusion in OxyContin packages, package. Practice Guideline '' ) ; United States Pharmacopeia-Dispensing Information 2238 tbl for chronic dosing, these physicians believed 1:1! ( 2 ) ) he filed the present qui tam suit was stayed, package... Public disclosure, declining to conclude that anything posted online would automaticallyconstitute a public disclosure claims against Purdue,. D. ) in addition to its inclusion in OxyContin packages, the company argues whereby Purdue at... An employer who had been accused of fraud on the particular scientific articles it cites appear before the court quot. 2005, he signed a severance agreement, which included a general release of all claims Purdue. For Mark Radcliffe & # x27 ; s supervision of a release to a... 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