However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. 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. Id. In his Complaint, Radcliffe alleges that Purdue "encouraged physicians to write prescriptions that were paid by Medicaid and other government programs for OxyContin that was materially less potent . 09-1202 (4th Cir. . The Fourth Circuit agreed that the district court did not have jurisdiction over the claims and affirmed. But see United States ex rel. Thus, allowing enforcement of such a release to bar a subsequent qui tam suit undermines the financial incentives thought necessary by Congress to ensure that those with inside knowledge file qui tam suits alerting the government of the alleged fraud and potentially assisting the government with its investigatory and prosecutory burden. ( Id. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. 1999). 582 F. Supp. Reply to Resp. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. United States ex rel. 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. 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. Kennedy v. Aventis Pharms., Inc., 512 F. Supp. 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. Va. 1989). Mark Radcliffe, 59, of Shady Spring, was convicted following a three-day jury trial. 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. 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. 2d 766, 774 (W.D. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. 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. 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. 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." It is undisputed that Radcliffe did not disclose the nature of his qui tam allegations to the government prior to the filing of his Complaint. Id. In this case, that information was the first FCA suit filed by Mark Radcliffe. 1:07-CR-00029 (W.D. Ten years ago, Mark Radcliffea former district sales manager for Purdue Pharma ("Purdue")filed a qui tam action under the FCA against Purdue. The government's decision not to intervene "does not necessarily signal governmental disinterest in an action, as it is entitled to most of the proceeds even if it opts not to intervene." 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. 1996). Id. 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. 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]. C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. Indus. Summary judgment is appropriate only if there are no material facts in dispute and the moving party is entitled to judgment as a matter of law. 2d at 1277. The parties have been provided with the sealed copy. 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. 1348 (quoting Fed.R.Civ.P. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. Mr. 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. 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." Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. Gebert v. Transp. Doyle v. Diversified Collection Services, Inc., No. On August 1, 2005, Radcliffe executed a general release as part of . (Mem. Matsushita Elec. Protected by Google ReCAPTCHA. In summary, Purdue argues that the public disclosures in these scientific articles and in the OxyContin package insert amount to a disclosure of the fraudulent transactions alleged in Radcliffe's qui tam suit and put the government on notice of the potential fraud. 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. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. 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. 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. He relies on United States ex rel. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. Certain sealed material has been redacted from the publicly released copy of this opinion. The general release executed by Radcliffe does not bar this action. 1999). He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." Id. at 969. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians. Id. at 1513. 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. McLean v. County of Santa Clara, No. Months later, the former employee filed a qui tam complaint in federal court. "); Longhi, 481 F. Supp. . Va. 2007) (accepting plea agreements). Radcliffe v. Purdue Pharma L.P., 582 F. Supp. 2007). 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 court found no statutory or policy reasons to prevent enforcement of the release. Purdue Pharma Br. at 1047. Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . When he raised the issue his supervisor assured him that the 2:1 ratio was correct. 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. 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. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. Hall involved an employer who had been accused of fraud on the government by an employee. The case previously reached the U.S. Court of Appeals for the Fourth Circuit, which refused to dismiss the case based on a lack of specific allegations because the whistleblowers still had the opportunity to amend their complaint. Radcliffe was interviewed a second time in September 2006 and asked about the misleading promotion of OxyContin. Mark Rad v. Purdue Pharma L.P., No. Thus, I find that these constitute public disclosures in the news media. 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. The opinion makes no mention of what type of web page this is or whether it bears any resemblance to a traditional periodical. 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. 1990)). Longhi involved a release executed eleven days after the relator filed a qui tam complaint. 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. 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. at 956-57. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 434. Redactions are denoted in brackets. 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit To the extent that Radcliffe based the allegations in his Complaint on either the published abstract or the published article, these constitute public disclosures in the news media. Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . 1991), which builds upon the Rumery test. The plaintiff-relator, Mark Radcliffe ("Radcliffe"), filed a qui tam suit in the United States District Court for the Western District of Virginia alleging that his former employer, Purdue Pharma, L.P. ("Purdue"), defrauded the government by marketing its pain-relief drug, OxyContin, as a cheaper alternative to the drug it replaced, MS Contin . The 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. 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. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. Id. 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 . Wilson v. Graham County Soil Water Conservation Dist., 528 F.3d 292, 309 (4th Cir. Bahrani, 183 F. Supp. at 963-64. at 1512-13. Purdue then filed the present Motion to Dismiss, seeking a dismissal on the grounds that Radcliffe's claims are based on publicly disclosed information rather than information he discovered; that Radcliffe has released Purdue from the claims; and that the Complaint fails to adequately allege fraud as required by Federal Rule of Civil Procedure 9(b). Id. Id. He attached to the complaint at least one document already in the government's possession: an "Answer Guide" used to train sales representatives, which urged them to emphasize OxyContin's higher potency and lower cost compared to MS Contin. 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. Whitten v. Triad Hosps., Inc., No. In doing so, the court relied on the test set forth in Town of Newton v. Rumery, 480 U.S. 386, 107 S.Ct. 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 . Will be used in accordance with our terms of service & privacy policy. 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. It is important to note that the government's decision not to intervene "does not necessarily signal governmental disinterest in an action, as it is entitled to most of the proceeds even if it opts not to intervene." Id. at 1512. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. Id. 31 U.S.C.A. 2d. 458 (S.D.N.Y. Relators claims had no objectively reasonable chance of success, the company argues. Apparently Radcliffe later experienced more doubts because in 2004 he sought legal advice and in January 2005 he anonymously contacted Randy Ramseyer, an Assistant United States Attorney for the Western District of Virginia, to gauge the government's interest in a claim against Purdue. However, he states that no details of the alleged misconduct were given and the attorney did not identify the name of his client. The Fourth Circuit does not have any analogous case law interpreting Rumery. United States ex rel. 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). Mark Rad v. Purdue Pharma L.P. Filing 920100324. The plaintiff has the burden of showing that the court has subject matter jurisdiction. 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. 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.. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: 2d at 1272. 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, and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. Purdue cites United States ex rel. After the qui tam suit was initiated, the NRC revisited its prior investigation and reached the same conclusions. 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. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. Green v. Serv. Id. 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.'" Specifically, they argue that, as here, where the government learned of the allegations independently and had already begun its investigation into the substance of the allegations prior to the date of the release, where the relator delayed in filing the qui tam complaint and attempted to settle with the defendants prior to doing so, and where the government ultimately chose not to intervene, enforcement of the release is appropriate. The state court action resulted in a settlement and general release, which was executed more than a year after the agency had completed its investigation. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. 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. 49.7 (Patrick D. Wall Ronald Mezack eds. Subsequent cases have not addressed this type of argument. 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. Mot. 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. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. Green, 59 F.3d at 962 (quoting Davies, 930 F.2d at 1396). But that is not sufficient to meet the rigorous standard of Rule 9(b). 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. 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." The court stated that the defendant "informed the [NRC] of Hall's concerns," but it does not necessarily follow that in doing so Hall was identified to the NRC. 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. 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. 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. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. at 965-66. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. 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. 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. 9 n.4. However, neither case discusses the policy implications of enforcing a release in the context of the FCA. at 231-32. 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.'" If not, then the court balances "all the factors that bear on whether `the public interest in enforcement of the agreement outweigh the policies furthered by non-enforcement.'" The FCA provides that there is no subject matter jurisdiction in a case where the claim is. 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. 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. 1997), has been applied by subsequent federal courts faced with the issue. 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. Inns of Am., Inc., 186 mark radcliffe purdue pharma Supp scientific dispute ( Cir! Rule 9 ( b ) Am., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp automaticallyconstitute. 1997 ), and Coleson v. Inspector general of the areas under investigation ''!, who left its employment shortly before he filed the present suit and! 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