. When Radcliffe raised this concern to supervisors, he was told that by approving the OxyContin package inserts, which contained the 2:1 equianalgesic ratio as a starting conversion that could later be adjusted by doctors, the U. S. Food and Drug Administration ("FDA") had approved that ratio. Dismiss, Exs. When he raised the issue his supervisor assured him that the 2:1 ratio was correct. . at 966. (f)(2).) Hall, 104 F.3d at 231. 2d 1158, 1164-65 (N.D. Ill. 2007). 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. United States of America, et al. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. (Information 20, United States v. Purdue Frederick Co., supra.) All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." 2010), the district court dismissed . 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. 1982). (Defs.' Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. 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). 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. (f)(2).) Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. Dismiss 11.) Id. at 817. 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. 1991), which builds upon the Rumery test. 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. School escapes liability for sex abuse by teacher, Walmart launches Constitutional attack on Lina Khan's FTC, Firefighters fired over penises drawn on Black colleague's family pictures lose lawsuit, Lawsuit targets Panera's Sip Club, complains refills have restrictions, Judge stops 3M's plan to handle massive earplug litigation. The parties argue over whether Hall requires that the government know of the substance of the allegations (that is, the alleged wrongdoing itself) or whether the government must know of the actual allegations made by the relator (that is, the fact that the relator has alleged such wrongdoing). . In January and February of 2005 Radcliffe sent emails to several officers and directors of Purdue, using the alias "John Femaledeer." 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. Under 3730(e)(4), an action is properly dismissed for lack of subject matter jurisdiction only if there was a public disclosure on which the relator's allegations were based and that relator is not an original source. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 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. Wilson, 528 F.3d at 299. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. Bahrani v. Conagra, Inc., 183 F. Supp. 2d 569, 576 (W.D. Id. 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. 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 Mot. 2548, 91 L.Ed.2d 265 (1986). at 963-64. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. 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. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. at 1512. 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. 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 state court action resulted in a settlement and general release, which was executed more than a year after the agency had completed its investigation. United States ex Noah Nathan v. Takeda Pharmaceuticals North America, Inc. Id. . 1994); United States ex rel. 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." 3730(e)(4)(A); see United States ex rel. However, the government ultimately took its investigation in a different direction, focusing on the misbranding of OxyContin as "less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications." (T)here is no question that counsels pre-filing knowledge and investigations are imputed to his clients on the issue of whether there is a good-faith, non-frivolous basis for the allegations in a complaint. Id. According to Assistant United States Attorney Rick A. Mountcastle, "one area of investigation concern[ed] whether Purdue falsely marketed OxyContin as being twice as potent as morphine and, accordingly, less expensive than MSContin." at 233. Finally, if the action was based on the public disclosure, was the relator an original source? The plea agreements included settlement of certain of the government's civil claims, but not of Radcliffe's qui tam suit. Id. Va. 2014) case opinion from the Southern District of West Virginia US Federal District Court . at 963. The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Wilson, 528 F.3d at 300-01 (alternations and internal quotations omitted); see Eberhardt v. Integrated Design Constr., Inc., 167 F.3d 861, 870 (4th Cir. 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. Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. 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. On August 1, 2005, Radcliffe executed a general release as part of . Va.)) None of the misbranding charges pertained to the relative cost and potency issue. 1999). & Training Trust Fund. See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. Id. 49.7 (Patrick D. Wall Ronald Mezack eds. App. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. United States ex rel. A doctor relying on the 2:1 ratio would initially prescribe half as much OxyContin as MS Contin, which, according to the relators, did cost less, Berger wrote. Will be used in accordance with our terms of service & privacy policy. 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."). 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. Id. Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. 1993) (quotations and citations omitted). 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. Several months later, Purdue restructured its sales force and Radcliffe was offered the option of transferring positions, which he declined, or termination with an extended severance package. (Mountcastle Decl. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. 1994) ("Textbook of Pain"). Yannacopolous v. General Dynamics, 315 F. Supp. 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. at 820. of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. 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. It is implausible to believe that doctors consistently used the 2:1 ratio as a starting point, prescribed significantly greater amounts as they titrated the dosage to the patients, and continued to believe OxyContin to be cost-effective based on the 2:1 ratio. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. 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. : 18-C-222 MSH, 18-C-233 MSH, 18-C-234 On September 18 2014 Defendants hereinafter Purdue filed.20141009i18 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. Doyle v. Diversified Collection Services, Inc., No. After the present qui tam suit was stayed, the government's investigation continued. This case briefly mentions several sources "two previously filed lawsuits against defendant, as well as an Internet web page and a Pittsburgh Post-Gazette article" and summarily concludes that "these constitute public disclosures." Mot. at 1513-14. Bahrani, 183 F. Supp. formerly a sales representative for Purdue under Mark Radcliffe's supervision. (Mem. However, neither case discusses the policy implications of enforcing a release in the context of the FCA. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. Id. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. Defs.' The two are represented by the same two attorneys who represented Mark Hurt and Roop. Id. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. 2005); see Springfield, 14 F.3d at 655. Reply to Resp. The employer in Green argued that because the government had ultimately become aware of the allegations and conducted its own investigation, the release would not have detrimental effects. It has held that public policy is implicated only where "it is explicit, well defined and dominant, and ascertainable by reference to the laws and legal precedents and not from general considerations of supposed public interests." Springfield Terminal Ry. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. 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. . 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. Virginia, Abingdon Division. In 2010, his wife Angela and former underling May filed their own FCA lawsuit. United States ex rel. Instead of the 2:1 ratio Purdue Pharma claimed, the actual ratio was more like 1.5:1, the whistleblowers said. at 962-63 (quoting Davies, 930 F.2d at 1399). 481 F. Supp. 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. 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. 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. 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. Mr. Dismiss 35.) But see United States ex rel. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). Michael Scheininger, counsel to several Purdue employees, stated that Department of Justice lawyer Barbara Wells informed him on June 24, 2005, of her intent to ask several of his clients about the dispute over the relative potency of OxyContin and MS Contin, explaining that it related to the marketing and cost implications. 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. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians. Radcliffe signed a general release of all claims against Purdue in exchange for an enhanced severance package. 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. 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. 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. 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 . 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 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. Id. 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. He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. The court did not inquire into the fullness of the government's investigation. 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." Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 784 n. 5 (4th Cir. Id. 40 F.3d at 1510. 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. F. Brian Ferguson. and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. at 963. 1039, 1043-47 (S.D.N.Y. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. 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. Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. Id. However, the decision to enforce the release turned on the fact that the release occurred "in the context of a bankruptcy proceeding, not through a general, independent release of a claim for money." See Fed.R.Civ.P. 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. 1994). 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. In addition to ruling the whistleblowers failed to sufficiently plead their allegations, Berger also found that their suit was barred by a rule that says whistleblowers cant bring suit over information that has already been made public. Id. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. 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. 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. at 916. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. Modification of these search terms occurred in December, 2005. 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. 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. Longhi involved a release executed eleven days after the relator filed a qui tam complaint. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. Same two attorneys who represented Mark Hurt and Roop to whether a substantial public interest be... E Corp. v. Days Inns of Am., Inc., No stay was lifted in 2006! The relator an original source ; s supervision Services, Inc., 992 F.2d,! 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