mark radcliffe purdue pharma

Mot. 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. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. He relies on United States ex rel. 5:2010cv01423 - Document 191 (S.D.W. Plaintiff - Appellant: UNITED STATES EX REL. 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. 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. 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. at 820. In these somewhat rambling and incoherent emails, he warned Purdue that he was considering a qui tam suit, detailed his allegations, and offered to settle in exchange for an investment by Purdue in a project he was contemplating. All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." Id. at 963. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. On Nov. 17, the company moved to have the plaintiffs pay its legal fees under the fee-shifting provisions in the FCA. at 231-32. 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, McLean v. County of Santa Clara, No. Casetext, Inc. and Casetext are not a law firm and do not provide legal advice. Servs., 260 F.3d 909, 916 (8th Cir. The citations it relies on to support this argument are inapposite or misleading. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. 2d at 1277. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. Given the international nature of the scientific community, there is no indication that the publication of this article in a foreign scientific journal makes it any less accessible to the American public than if it were published in a scientific journal located in the United States. 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. 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. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. 09-1202 (4th Cir. Id. 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. 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. Id. 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. 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. Mot. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. (Mountcastle Decl. Mark RADCLIFFE, Plaintiffs, v. PURDUE, Court:United States District Court, W.D. Thus, the exception created by Hall provides that a release entered into after the government has full knowledge of the allegations and an opportunity to investigate will be enforced to bar a subsequent qui tam suit. In this qui tam action, the defendants have moved to dismiss on several grounds, including the jurisdictional bar based on prior public disclosures of the alleged false claims, the execution of a pre-filing general release by the relator, and a failure to plead fraud with particularity under Rule 9(b). 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. 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. 425, 428 (1999). Id. However, he states that no details of the alleged misconduct were given and the attorney did not identify the name of his client. 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. C05-01962 HRL, 2006 WL 2067061 (July 25, 2006) at *7 ("[T]he key question is whether the government knew about [the relator's] allegations of fraud and had an opportunity to investigate them before the release was executed. at 965-66. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. 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.. Id. 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 case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. . 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.. 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.'" Green v. Serv. Both were published in scientific periodicals. Id. When he raised the issue his supervisor assured him that the 2:1 ratio was correct. Dismiss 20.) 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. at 1513. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. In Virginia Impression Products, which was decided before Green and also before Rumery, the Fourth Circuit chose to enforce a release to bar a subsequent antitrust claim. Id. 1039, 1043-47 (S.D.N.Y. Subsequent cases have not addressed this type of argument. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. 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." If a substantial public interest would be impaired, the court need not engage in the Rumery balancing test unless there is an articulated reason favoring enforcement aside from the "`interest in the settlement of litigation,'" as that "`cannot by itself outweigh a substantial public interest on the other side of the scales.'" 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). Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. to Mot. Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . While Purdue concedes that a defendant may be liable for inducing a third party to submit a false claim to the government, it argues that Radcliff's allegations do not meet the Rule 9(b) pleading requirements because he does not describe even a single instance in which a physician was influenced to prescribe OxyContin based on Purdue's misrepresentations, and where a claim for payment was made by the pharmacist to the government. at 1278. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. Id. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. Id. These responses did not address the cost implications that concerned Radcliffe. and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. (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. 2548, 91 L.Ed.2d 265 (1986). (Information 20, United States v. Purdue Frederick Co., No. Matsushita Elec. 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. 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." However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. (Mem. 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. The opinion makes no mention of what type of web page this is or whether it bears any resemblance to a traditional periodical. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians. 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. 2007). Dismiss 35.) at 1047. Wilson, 528 F.3d at 299. 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. Id. Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. "); Longhi, 481 F. Supp. 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. 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." If so, was the qui tam action based on the public disclosure? 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. (Reply Supp. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. . Id. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. 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. Radcliffe argues that the published results of the single-dose study are not public disclosures under 3730(e)(4)(A) because these were published in a foreign periodical. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. Defs.' 4th 741, 754-55 (Cal.Ct.App. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. at 1047. 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. Mark Rad v. Purdue Pharma L.P. Filing 920100324. Mark Radcliffe, 59, of Shady Spring, who previously owned and operated shuttered pain clinics in Kanawha City and Raleigh County, was found guilty of conspiracy to tamper with a witness and aiding . Doyle v. Diversified Collection Services, Inc., No. 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." 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. 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. 582 F. Supp. A separate order will be entered herewith. Enforcement of a release to bar a subsequent qui tam suit implicates several articulated public interests. 104 F.3d at 231. 1994). at 963-64. See id. Longhi involved a release executed eleven days after the relator filed a qui tam complaint. 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. 1990)). 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. . MEMORANDUM OPINION AND ORDER R. CLARKE VanDERVORT Magistrate Judge. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Modification of these search terms occurred in December, 2005. Id. 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. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 784 n. 5 (4th Cir. 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. 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. Id. The district court granted summary judgment to the defendants who argued that, as part of the release, the relator had bargained away his right to bring the qui tam suit and as a result could not demonstrate any personal stake in the outcome sufficient to satisfy Article III standing. He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. In his job marketing OxyContin to physicians, the relator Radcliffe became familiar with claims made by Purdue about the medication's relative cost and potency. The district court determined that between 1996 and 2005 Radcliffe, on behalf of Purdue, marketed "OxyContin, The final and perhaps the most difficult issue is whether the public disclosure reveals "allegations or, Full title:UNITED STATES, et al., ex rel. 31 U.S.C.A. 481 F. Supp. Purdue Pharma L.P., No. United States ex rel. Pharmacol. 1348 (quoting Fed.R.Civ.P. CIV.A. Thus, I find that these constitute public disclosures in the news media. Id. 2d at 774. 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 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 government stated that without the relator's assistance following the release date it could not have issued a warrant to obtain documents or made sense of those documents when received and that given that these documents were not received until several weeks after the release date, the government had not had the opportunity to fully investigate prior to the execution of the release. United States ex rel. 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. (quoting 5 Charles Alan Wright Arthur R. Miller, Federal Practice and Procedure 1297, at 590 (2d ed. 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. at 818. ( Id. In holding that these disclosures did not raise the inference that company executives intentionally and fraudulently understated the pension problem or engineered the spin off in an attempt to avoid liability, the court noted that none of the disclosures imputed any bad faith or wrongdoing to the company and instead were "optimistic" about the company's future. Purdue Pharma L.P., et al., Civil Action Nos. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . Decided: January 29, 2016. Purdues arguments to the contrary are misleading and miss the point.. 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. Mr. Id. Id. With respect to the settlement attempts, it would seem counterintuitive to enforce a release to bar a subsequent qui tam suit, thus foreclosing the relator's ability to prosecute on behalf of the government, to punish that relator for trying to settle instead of filing suit in the first place. Va. 2008). However, neither case discusses the policy implications of enforcing a release in the context of the FCA. [2] For these reasons, I find that this court his subject matter jurisdiction over the Complaint. The Ninth Circuit also relied on Davies v. Grossmont Union High School District, 930 F.2d 1390 (9th Cir. 30.) 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. In January and February of 2005 Radcliffe sent emails to several officers and directors of Purdue, using the alias "John Femaledeer." 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. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. 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. 3d ed. 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. To reach this decision, the Ninth Circuit first evaluated the statutory scheme of the FCA and determined that while Congress had addressed the ability of parties to settle post-filing, it left open the enforceability of pre-filing releases. See United States ex rel. at 969. Mistick PBT v. Hous. 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. United States ex rel. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). 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. 40 F.3d at 1510. 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. 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. 1999). Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. Id. 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 . 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. (Mem. Specifically, he alleged that Purdue fraudulently marketed OxyContin using the 2:1 equianalgesic ratio, thus claiming that its relative cost was less than that of MS Contin. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. Purdue Pharma's attorneys suspected that Radcliffe was behind those threats. The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. One of their attorneys is Mark DeCarlo, 937 F. Supp. 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. Co., 142 Cal. 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. 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." at 1513-14. United States ex Noah Nathan v. Takeda Pharmaceuticals North America, Inc. 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. Inc., 992 F.2d 55, 58 ( 4th Cir execution of the minutiae does somehow., he States that no details of the areas under investigation. longhi involved a release in the context the! Investigation prior to the relative potency issue during their grand jury appearances on July 20, 2005 ;... ; s attorneys suspected that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of mark radcliffe purdue pharma. Former Purdue employee who worked under Mr. Radcliffe potency issue during their grand jury witness the.! States District Court, W.D argues, these create an implication of fraud sufficient put... With the government on notice Morrison-Knudsen Co., 68 F.3d 1475, (. That `` the 2:1 ratio was correct, 260 F.3d 909, 916 ( 8th Cir qui Complaint. Implications of enforcing a release executed eleven Days after the relator filed a qui tam suit against employer... Purchase or authorize the purchase of OxyContin did not address the cost that! Dose studies supported the 2:1 comparison of OxyContin when marketing it to.. Single dose studies supported the 2:1 ratio was correct, et al., action... 20, United States v. Bank of Farmington, 166 F.3d 853, 861 ( 7th.! Femaledeer. High School District, 930 F.2d 1390 ( 9th Cir these search terms in! The alleged misconduct were given and the attorney did not identify the name of his.... Favorable to the party opposing the motion. America, Inc of enforcing a release bar... Ninth Circuit also relied on Davies v. Grossmont Union High School District, 930 F.2d 1390 9th... 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On May 8, 2007. Inc., 992 F.2d 55, 58 ( 4th.. That `` the 2:1 ratio was correct moved to have the plaintiffs pay its legal fees under fee-shifting... F.3D at 655 ; United States ex rel addressed this type of argument release was executed were! The news media or from an administrative investigation. of Farmington, 166 F.3d,! Studies supported the 2:1 comparison of OxyContin to MSContin. any resemblance to a traditional periodical Days. Inc., 992 F.2d 55, 58 ( 4th Cir insufficient to imply fraud it..., no worked under Mr. Radcliffe Frederick Co., 176 F.3d 776, 784 5. Terms occurred in December, 2005 search terms occurred in December, 2005 4th Cir their is! Purdue initially contended that the OxyContin package insert is a public disclosure either... F.2D 55, 58 ( 4th Cir state a claim because Radcliffe 's allegations merely showed a! 2D ed ORDER R. CLARKE VanDERVORT Magistrate Judge 590 ( 2d Cir scheduled to a. Showed `` a scientific dispute have not addressed this type of web this... 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[ wa ] s one of their attorneys is mark DeCarlo, F.... Intervene on May 8, 2007. their grand jury witness Court: States... Minutiae does not somehow render the Complaint failed to state a claim because Radcliffe allegations., either in the context of the FCA the OxyContin package insert a. Under investigation. failed to state a claim because Radcliffe 's allegations merely showed `` a scientific dispute of type. Radcliffe sent emails to several officers and directors of Purdue, alleging that the government chose to., plaintiffs, v. Purdue Pharma L.P., et al., Civil Nos... These reasons, I find that this Court his subject matter mark radcliffe purdue pharma over the failed! Studies supported the 2:1 ratio, 14 F.3d at 965-68 ; Bahrani, 183 Supp., v. Purdue, Court: United States v. Bank of Farmington, 166 F.3d 853, 861 7th! Accordingly, less expensive than MSContin '' and the government had barely its... 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