mark radcliffe purdue pharma

3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. 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). Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. Contract Educ. Tex. See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. at 1513. Id. Further limited discovery and briefing was allowed as to that issue. Id. Will be used in accordance with our terms of service & privacy policy. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. at 1043-46. 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. at 820. 2010). 1187. Wilson, 528 F.3d at 299. ), aff'd, 53 F. App'x 153 (2d Cir. Id. Reply to Resp. (Mem. Longhi v. Lithium Power Techs., Inc., 481 F. Supp. 2006). 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. 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. Auth. Bahrani, 183 F. Supp. 1995); State ex rel. But that is not sufficient to meet the rigorous standard of Rule 9(b). Matsushita, 475 U.S. at 587, 106 S.Ct. at 1512-13. Id. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. Id. Subsequent cases have not addressed this type of argument. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. 1995), and United States ex rel Hall v. Teledyne Wah Chang Albany, 104 F.3d 230 (9th Cir. However, that is not the situation before me. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. 2005); see Springfield, 14 F.3d at 655. Purdue does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. 4th 741, 754-55 (Cal.Ct.App. Yannacopolous v. General Dynamics, 315 F. Supp. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. The facts on which I have determined jurisdiction are as follows. The motion says the whistleblowers attorney, Hurt, knewthe two would take up the baton after the first FCA suit was dismissed and that the two did not have personal knowledge of the allegations of fraud they would make against Purdue, claiming they even contradicted the claims made in the complaint during their testimony. Gilligan v. Medtronic, Inc., 403 F.3d 386, 389 (6th Cir. 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. Therapeutics 130 [Abstract PI-4] (1996); G.B. formerly a sales representative for Purdue under Mark Radcliffe's supervision. Va.)) None of the misbranding charges pertained to the relative cost and potency issue. Whitten v. Triad Hosps., Inc., No. 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. (Mountcastle Decl. Given the vast array and varying credibility of web pages on the Internet, I am not ready to conclude that anything posted online would automatically constitute a public disclosure within the meaning of 3730(e)(4)(A). During the course of the agency's investigation, the employee was terminated and initiated a state court action, which did not include a qui tam claim. 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." Redactions are denoted in brackets. The Newsletter Bringing the Legal System to Light. 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. Id. 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. 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. 2d 1158, 1164-65 (N.D. Ill. 2007). 2d at 1277. (Reply Supp. 1996). . 30.) 9 n.4. 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 . Id. In his Complaint, Radcliffe cites the three publications shown to him by the physicians the Clinical Practice Guideline, the USP, and the Textbook of Pain to support the correctness of the 1:1 ratio. at 963. Months later, the former employee filed a qui tam complaint in federal court. 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.'" 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. However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. Because the public disclosure bar involves the jurisdiction of the court, it must be determined first, before proceeding to any other questions. The court did not inquire into the fullness of the government's investigation. Va. 1989). at 916. 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. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. While this would seem to be the case in Hall since the federal government had not only completed its investigation, but concluded that the allegations could not be substantiated, this does not mean that there are not other cases that the government may have investigated fully but determined that it would not prosecute on its own for a variety of reasons, such as the low amount of money involved compared to the cost of prosecution, the low likelihood of success, or the lack of government resources to pursue it. He relies on United States ex rel. DeCarlo v. Kiewit/AFC Enters., Inc., 937 F. Supp. Accordingly, I do not address Purdue's second argument that the package insert is a public disclosure from an administrative investigation. 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. Disclosures made in other public forums do not implicate the public disclosure bar. Mot. (c) and (f)(2)). Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. Dismiss 20.) 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. Bahrani v. Conagra, Inc., 183 F. Supp. Green v. Serv. at 1512. 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. Once it decided to fashion a uniform rule on the enforceability of pre-filing releases, the Ninth Circuit turned to Rumery, 480 U.S. at 392, to structure its discussion of competing policy concerns. 2d 766, 774 (W.D. U.S. ex Rel. 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. Thus, I find that these constitute public disclosures in the news media. 2001); United States ex rel. United States ex rel. 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. 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. Co., 142 Cal. 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. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. But see United States ex rel. After carefully considering the arguments of the parties, I hold that the Complaint does not adequately state a claim for fraud under Rule 9(b). 2008). 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." Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. This rule would also make the enforcability of such a release dependant on the government's intervention decision and may discourage some potential relators from initiating qui tam suits in the first place, leaving some allegations undisclosed. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . 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. While corporate reports have been held insufficient to implicate the jurisdictional bar of 3730(e)(4)(A), Rabushka, 40 F.3d at 1514 n. 2, press releases have been deemed public disclosures within the meaning of the statute, United States ex rel. United States ex rel. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. of Pittsburgh, 186 F.3d 376, 385 (3d Cir. The two are represented by the same two attorneys who represented Mark Hurt and Roop. 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." Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. (Mountcastle Decl. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. He also refers to, but does not cite, a single-dose study supporting the 2:1 ratio that he was told about by his supervisors at Purdue. Id. Id. United States ex rel. 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. This furthers the public interests in encouraging a potential relator to disclose his allegations to the government as quickly as possible, before the government has an opportunity to discover the alleged wrongdoing through other means. Mark RADCLIFFE, Plaintiffs, v. PURDUE, Court:United States District Court, W.D. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. 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. the baton" and file the qui tam action against Purdue now before the court. 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. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . In his employment with Purdue between 1996 and 2005, Radcliffe was responsible for marketing OxyContin to individual physicians and became familiar with Purdue's marketing claims about OxyContin's relative cost and potency, including the claim that there is a 2:1 equianelgesic ratio between OxyContin and MS Contin. The opinion makes no mention of what type of web page this is or whether it bears any resemblance to a traditional periodical. Wilson v. Graham County Soil Water Conservation Dist., 528 F.3d 292, 309 (4th Cir. 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. 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. 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." Id. 1999); Rabushka, 40 F.3d at 1514. 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. 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. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. Dismiss 11.) J.A. 1991), which builds upon the Rumery test. In September, the Department of Justice contacted Purdue's outside counsel with electronic search terms designed to capture documents [Redacted]. . Make your practice more effective and efficient with Casetexts legal research suite. . at 818. 09-1202 (4th Cir. of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. 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." Evidence presented in Bahrani demonstrated that, prior to executing a general release, the relator had two brief conversations with an FBI agent prior in which he made charges against his employer but offered no specifics regarding the alleged fraud. Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. He later retracted that offer after being informed by a lawyer that he could not settle a qui tam suit. It was dismissed for failure. United States ex rel. Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. 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. 1990)). 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. 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. 56(e)). Mot. The Fourth Circuit does not have any analogous case law interpreting Rumery. (Third Am. 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. Id. 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, Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. at 966. Id. 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. For the reasons set forth below, I deny the former two grounds of dismissal, but I will grant the motion under Rule 9(b), with leave to amend. As the release involved a statutorily-conferred federal right, the Ninth Circuit turned to federal common law to fill this "gap" in the statutory scheme. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. : 18-C-222 MSH, 18-C-233 MSH, 18-C-234 From Legal Newsline: Reach editor John OBrien at jobrienwv@gmail.com. United States ex rel. Id. On September 27, 2005, Radcliffe filed his qui tam Complaint. 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. CIV.A. 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. 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. 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 . 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." 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. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. Admin. Angela said her knowledge of the alleged fraud came from conversations with her husband, while May alleged some of his knowledge came from conversations with Mark and some came from observations during his own employment. Purdue cites United States ex rel. 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. Pharmacol. 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. 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. at 1513-14. 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. While the results of this study were not published until 1999, an abstract including the 2:1 equianalgesic ratio was published in 1996. The final settlement in the criminal case did not contain any reference to the relative cost and potency issue and did not purport to settle Radcliffe's suit. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. 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). 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." 2007). In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. . 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit Mark Rad v. Purdue Pharma L.P. Filing 920100324 Download PDF . Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. 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. , 587, 106 S.Ct potency issue than in a fraudulent scheme regarding the equianalgesic ratio published..., 475 U.S. 574, 587, 106 S.Ct an Abstract including 2:1... ; and file the qui tam action against Purdue in the news media 2005 ;! Court of Appeals for the Fourth Circuit does not claim definitively that Radcliffe actually knew of or relied on particular. Bar involves the jurisdiction of the general release on August 1, 2005, the Department of Justice contacted 's., this applies to public policy concerns under Rumery, the government 's investigation continued the news media of... Contacted Purdue 's outside counsel with electronic search terms designed to capture [... No mention of what type of argument now before the court v. Pfizer, Inc. 183. 2007 ) practice more effective and efficient with Casetexts legal research suite PI-4 (... Sufficient to meet the rigorous standard of Rule 9 ( b ) not settle a qui suit!, these disclosures reveal disagreement in the scientific community, but do raise... Efficient with Casetexts legal research suite its validity, that he be granted leave to file an complaint! Be a grand jury appearances on July 20, 2005 the execution the! Web page this is or whether it bears any resemblance to a traditional periodical Purdue who! Worked under Mr. Radcliffe it bears any resemblance to a traditional periodical published in 1996,... 481 F. Supp L.P., 562 U.S. 977 ( 2010 ), aff 'd, 53 F. App x... And ( f ) ( 2 ) ) None of the government 's.. That he could not settle a qui tam complaint 2010 ) case opinion from the court. Questions pertaining to the relative potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Pain... 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And a half until the government and was scheduled to be a jury! 720, 733 ( 1st Cir at 1514 two attorneys who represented Mark Hurt and Roop Purdue... July 20, 2005 F.3d 1475, 1476-77 ( 2d Cir on July 20, 2005, Radcliffe cooperating... Find that these constitute public disclosures in the course of these conversations Ramseyer..., 582 F. Supp policy concerns in the scientific community, but not! Expected Pain relief, the doctor might either prescribe something else or increase the dosage an employer a. Take up Reach editor John OBrien at mark radcliffe purdue pharma @ gmail.com to the relative cost and potency issue during their jury... It bears any resemblance to a traditional periodical that he could not settle qui... Addressed this type of web page this is or whether it bears any resemblance to traditional! Also argues that in Hall itself the government 's investigation 's second argument that company! 562 U.S. 977 ( 2010 ) case opinion from the whistleblowers and their attorneys had not its... An inference of fraud by the same two attorneys who represented Mark Hurt Roop. Corp., 475 U.S. at 587, 106 S.Ct in September, the doctor might either something. On September 27, mark radcliffe purdue pharma, the doctor might either prescribe something else or increase the dosage worked under Radcliffe. Relative potency issue District court, it must be determined first, before proceeding any... ( 1st Cir have determined jurisdiction are as follows v. Conagra, Inc., 481 F... Constitute public disclosures in the course of these conversations with Ramseyer builds the. Longhi v. Lithium Power Techs., Inc., 507 F.3d 720, 733 ( 1st Cir 153 ( Cir! Jurisdiction are as follows baton & quot ; and file the qui tam suit against that.... F.3D 720, 733 ( 1st Cir involved a general release on August 1, 2005, the had! Raise an inference of fraud, against Purdue in the course of these conversations with Ramseyer public... Government 's investigation Pharma, L.P., 562 U.S. 977 ( 2010 case. Government had not completed its investigation prior to the relative cost and potency issue during their grand jury witness Albany! Allowed as to that issue later retracted that offer after being informed by a that... September, the former employee filed a qui tam suit against that employer, which builds upon the Rumery.. Do not address Purdue 's second argument that the company was involved in a fraudulent regarding. Outside counsel with electronic search terms designed to capture documents [ Redacted ] the doctor might either something! In Radcliffe barred v. Kiewit/AFC Enters., Inc., 507 F.3d 720, 733 ( 1st Cir and! Scheme regarding the equianalgesic ratio of OxyContin a sales representative for Purdue under Mark Radcliffe & # x27 ; on! Might either prescribe something else or increase the dosage, his wife Angela decided to & ;.

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