Radcliffe v. Purdue Pharma L.P., 600 F.3d 319, 321-22 (4th Cir. Va.)) None of the misbranding charges pertained to the relative cost and potency issue. 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. 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. See DeCarlo, 937 F. Supp. However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. 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. 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 . 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. For convenience, references herein to the "Complaint" shall include the most recent version. Subsequent cases have not addressed this type of argument. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. 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. Wilson v. Graham County Soil Water Conservation Dist., 528 F.3d 292, 309 (4th Cir. The allegations claimed Purdue Pharma marketed OxyContin with a false claim that a patient could use half as much OxyContin as MS Contin to treat the same pain. F. Brian Ferguson. 434. In such cases, I can hardly think that the mere fact of a government investigation would negate the public interest in having a private citizen shoulder the burden of prosecution that would allow the government to recover monies lost through fraud. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. United States ex rel. Green, 59 F.3d at 959. However, neither case discusses the policy implications of enforcing a release in the context of the FCA. Purdue contends that Radcliffe released the claim made in his Complaint in the course of a settlement agreement with Purdue when he left its employment. United States ex rel. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. Despite the labeling of the 2001 page, I find that this is not analogous to a traditional news outlet or periodical or even a trade journal because it involves information disseminated by one company about its own products, rather than a news organization or industry group disseminating information of general or specialized interest. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. 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." 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. Id. 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. 434. at 965-66. Mot. Although antitrust cases are similar to qui tam suits in that the government relies on the enforcement efforts of private parties, the policy implications and economic incentives differ. 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. ex rel. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 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. 1996). 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. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. Id. 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. Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). 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. . 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). Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. 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. Va. 2007) (accepting plea agreements). 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. Mr. 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. He alleged a fraudulent scheme whereby Purdue marketed 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. 2007). . Yannacopolous v. General Dynamics, 315 F. Supp. (Mountcastle Decl. 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. Will be used in accordance with our terms of service & privacy policy. 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. Id. Id. . Id. 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. Purdue urges the court to consider pre- Green cases Virginia Impression Products Co. v. SCM Corp., 448 F.2d 262 (4th Cir. Grayson v. Pac. The Newsletter Bringing the Legal System to Light. Mark Rad v. Purdue Pharma L.P., No. They alleged these statements were made to doctors whose patients obtained prescriptions paid for by the government, creating a claim under the False Claims Act. Purdue cites United States ex rel. As in Green, the Ninth Circuit in Hall relied on the Rumery test, but concluded that the concerns that weighed against enforcement in Green were not present. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). United States ex rel. 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. In this case, that information was the first FCA suit filed by Mark Radcliffe. . Compl. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. 2001); United States ex rel. In September, the Department of Justice contacted Purdue's outside counsel with electronic search terms designed to capture documents [Redacted]. Relators claims had no objectively reasonable chance of success, the company argues. 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.'" Were this the rule, a relator who initially tried to settle would have no incentive to disclose the allegations to the government in lieu of settlement. at 963. Springfield Terminal Ry. App. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. These include the public interest in having relators disclose inside information of alleged fraud to the government, in having relators supplement federal enforcement of the FCA by assisting the government in its investigation and prosecution or prosecuting the claim itself, and in deterring future fraud against the government. Because the public disclosure bar involves the jurisdiction of the court, it must be determined first, before proceeding to any other questions. 1990)). 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. Id. 1039, 1043-47 (S.D.N.Y. Matsushita, 475 U.S. at 587, 106 S.Ct. Hall involved an employer who had been accused of fraud on the government by an employee. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. (Third Am. 458 (S.D.N.Y. It is unclear from the Complaint and subsequent filings whether Radcliffe ever read this study or merely heard about it from the supervisors and physicians. (Mountcastle Decl. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. 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. 2d at 1278. Decided: January 29, 2016. Radcliffe was a district sales manager for Purdue, laid off as part of a reduction in force in June 2005. 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. 1993) (quotations and citations omitted). Auth. 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. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. Accordingly, I do not address Purdue's second argument that the package insert is a public disclosure from an administrative investigation. Green, 59 F.3d at 956. 2d 569, 576 (W.D. Id. (Information 20, United States v. Purdue Frederick Co., supra.) On June 23, 2005, the government requested that Purdue identify the author and source of different versions of a document [Redacted] already in the government's possession, [Redacted]. Id. 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. 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. at 232. 40 F.3d at 1510. Id. Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . (Information 20, United States v. Purdue Frederick Co., No. Gebert v. Transp. Pharmacol. 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. at 308. 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. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. Hurt thus acted in bad faith by bringing an action when he knew that Relators had no personal knowledge of the allegations he drafted in their name.. Purdue has withdraw that argument, including its related Request for Judicial Notice. Likewise, the public interest in using qui tam suits to supplement federal enforcement of the FCA was not disturbed as the government had already investigated the allegations prior to the release. 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. Gilligan v. Medtronic, Inc., 403 F.3d 386, 389 (6th Cir. Radcliffe also avers that. United States ex rel. 1997), has been applied by subsequent federal courts faced with the issue. 56(e)). 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.'" 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). Mark RADCLIFFE, Plaintiffs, v. PURDUE, Court:United States District Court, W.D. It was dismissed for failure. 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]. In Hall, the Nuclear Regulatory Commission ("NRC") completed and closed an investigation after the defendant made it aware of the relator's allegations, before the filing of the qui tam complaint. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. 2007). Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. 3730(e)(4)(A); see United States ex rel. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. 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. 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 plea agreements included settlement of certain of the government's civil claims, but not of Radcliffe's qui tam suit. J. Clin. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. He relies on United States ex rel. McLean v. County of Santa Clara, No. However, that is not the situation before me. 2010). 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. On September 18 2014 Defendants hereinafter Purdue filed.20141009i18 49.7 (Patrick D. Wall Ronald Mezack eds. 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. 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. United States of America, et al. Defs.' 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. 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. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. 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. Pharmacol. Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. (Defs.' By the end of July, the government had also begun drafting Grand Jury Subpoena 513 which included requests for all documents discussing the relative analgesic potency or safety of OxyContin and MS Contin. (c).) 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."). Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. , W.D Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct Corp., F.2d. And again Purdue Pharma L.P., 562 U.S. 977 ( 2010 ), and Coleson v. Inspector mark radcliffe purdue pharma the. Federal courts faced with the issue, 562 U.S. 977 ( 2010 ), Coleson., declining to conclude that anything posted online would automaticallyconstitute a public disclosure from an administrative investigation court subject... Is found insufficient on this ground, that he be granted leave to file amended... 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