mark radcliffe purdue pharma

Id. 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. Hall involved an employer who had been accused of fraud on the government by an employee. at 1513-14. However, it is also clear from the evidence that the government continued to seek such information after the release had been executed on August 1, 2005. Id. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. 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. 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. 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. Disclosures made in other public forums do not implicate the public disclosure bar. 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. 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. C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. Va. 2008). 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. Yannacopolous v. General Dynamics, 315 F. Supp. decision in United States ex rel. Id. Radcliffe also avers that. Id. 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. See id. . The two are represented by the same two attorneys who represented Mark Hurt and Roop. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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. All of the issues are now ripe for decision and will be discussed sertiam. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 1:07-CR-00029 (W.D. 1993) (quotations and citations omitted). Grayson v. Pac. (f)(2).) 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. 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. The Ninth Circuit determined that enforcement of the release would impair the public interest by diluting incentives to file qui tam suits, thus making the government less likely to learn of the alleged fraud, and by diluting the FCA's deterrent affect. 2008). Dismiss 35.) Id. 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. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. & Training Trust Fund. Va. 2007) (accepting plea agreements). at 308. Purdue does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. 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. at 1278. Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . That agency investigated and concluded that it could not substantiate the allegations. U.S. ex Rel. 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 Id. The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. United States ex rel. It was dismissed for failure to plead fraud with sufficient particularity. 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." Id. Purdue cites Gebert, 260 F.3d 909, in which the government did not investigate until after the filing of the qui tam complaint and the court ultimately chose to enforce the release. Compl. 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. 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. 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). of Pittsburgh, 186 F.3d 376, 385 (3d Cir. Mark Rad v. Purdue Pharma L.P., No. Id. Id. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. 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."). See DeCarlo, 937 F. Supp. 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. 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. 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. Casetext, Inc. and Casetext are not a law firm and do not provide legal advice. 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. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. 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. 2007). 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." J. Clin. 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. 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. The plaintiff has the burden of showing that the court has subject matter jurisdiction. The FCA provides that there is no subject matter jurisdiction in a case where the claim is. 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. 2d 815, 818 (S.D. 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. With respect to Radcliffe's delay in filing his qui tam suit, I agree that this does weigh in favor of enforcement as a means to encourage relators to file quickly and disclose their allegations to the government as soon as possible. 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. 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. Green, 59 F.3d at 962. Dismiss 20.) However, that is not the situation before me. United States ex rel. The Ninth Circuit also relied on Davies v. Grossmont Union High School District, 930 F.2d 1390 (9th Cir. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. Mot. 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." In his Complaint, Radcliffe references, but does not cite, a single-dose potency study that his supervisors told him supported an equianalgesic ratio of 2:1. (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. 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. 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. 5:2010cv01423 - Document 191 (S.D.W. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. Matsushita Elec. 1999). On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). Contract Educ. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. 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. A separate order will be entered herewith. at 233. 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. 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. Mr. Springfield Terminal Ry. In doing so, the court relied on the test set forth in Town of Newton v. Rumery, 480 U.S. 386, 107 S.Ct. Id. 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. 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. (Information 20, United States v. Purdue Frederick Co., No. 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. 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. Protected by Google ReCAPTCHA. at 817. That provision says the court may award reasonable attorneys fees and expenses if the court finds the lawsuit was clearly frivolous or vexatious or brought primarily for purposes of harassment. Id. 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. 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. of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. During this period or time, the government was conducting its own comprehensive investigation into Purdue's manufacturing, marketing, and distribution of OxyContin. at 818. Document production requests made by the government and conversations between lawyers representing the government and Purdue or its employees in June and July of 2005 suggest that the government was trying to learn more about the relative cost and potency issue. formerly a sales representative for Purdue under Mark Radcliffe's supervision. 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.. Regardless, the 1996 abstract was published in Clinical Pharmacology Therapeutics, a scientific journal headquartered in Alexandria, Virginia. The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. 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. 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. 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. First, was there a public disclosure? 2d. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. (Defs.' 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. Partial knowledge or investigation on the part of the government is insufficient to remove a case from the purview of Green into the exception created by Hall. 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. and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." 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. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. (Mountcastle Decl. the baton" and file the qui tam action against Purdue now before the court. 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. He later retracted that offer after being informed by a lawyer that he could not settle a qui tam suit. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). (Mountcastle Decl. 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. 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. 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. Longhi involved a release executed eleven days after the relator filed a qui tam complaint. 434. 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. And potency the present suit I find that this court his subject matter jurisdiction over the Complaint, the., accordingly, less expensive than MSContin '' and the accuracy of `` the 2:1 comparison of OxyContin release eleven., 930 F.2d 1390 ( 9th Cir reasons, I find that this court his matter... 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