The facts on which I have determined jurisdiction are as follows. 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. Months later, the former employee filed a qui tam complaint in federal court. 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. at 1513-14. 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. These responses did not address the cost implications that concerned Radcliffe. 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. Purdue cites United States ex rel. 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. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. 1994) ("Textbook of Pain"). ex rel. 09-1202 (4th Cir. at 820. 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. Will be used in accordance with our terms of service & privacy policy. 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. (Mountcastle Decl. United States ex Noah Nathan v. Takeda Pharmaceuticals North America, Inc. 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). DeCarlo v. Kiewit/AFC Enters., Inc., 937 F. Supp. Purdue argues that, under Rumery, the circumstances present here do not implicate the public interests articulated in Green, do not outweigh the general interest in settling litigation, and, thus, support enforcement of the release to bar this qui tam suit. He was also told that Purdue's decision to rely on the 2:1 ratio, despite published articles indicating that the 1:1 ratio was more appropriate for OxyContin's approved use, was based on safety concerns, that is, it was better for doctors to start with a lower dose and adjust upward if necessary. 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). Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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. the baton" and file the qui tam action against Purdue now before the court. 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. 1:07-CR-00029 (W.D. 1039, 1043-47 (S.D.N.Y. Purdue Pharma, L.P. (1:05-cv-00089) District Court, W.D. 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. Rabushka v. Crane Co., 40 F.3d 1509, 1512-14 (8th Cir. Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. He later retracted that offer after being informed by a lawyer that he could not settle a qui tam suit. 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. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. On August 1, 2005, he signed a severance agreement, which included a general release of all claims against Purdue. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. 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 963. 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. 763 (E.D. Yannacopolous v. General Dynamics, 315 F. Supp. One of their attorneys is Mark Mot. 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." Nathan v. Takeda Pharmaceuticals N.A. However, he states that no details of the alleged misconduct were given and the attorney did not identify the name of his client. Id. The Fourth Circuit does not have any analogous case law interpreting Rumery. See Fed.R.Civ.P. Notwithstanding the government's lack of knowledge of or consent to the release, because the federal government was already aware of the allegations of fraud, the public interest in having information disclosed to the government was not implicated. 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." 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. 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. Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . 56(e)). BECKLEY, W.Va. - A Raleigh County man was sentenced today to five years in federal prison and ordered to pay a $25,000 fine for a witness tampering crime, announced United States Attorney Carol Casto. As in Bahrani, when the release was executed there was no guarantee that the government would end up prosecuting based on the relator's allegations. 2010). Mark Rad v. Purdue Pharma L.P., No. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. Ramseyer recalls receiving a telephone call from a West Virginia attorney regarding a possible qui tam suit against Purdue at some point prior to September 27, 2005. Gebert v. Transp. These disclosures suggest legitimate scientific debate and disagreement regarding the correct equianalgesic ratio, rather than any fraudulent intent on the part of Purdue. Id. Id. This is factually distinct from the situation in which the government is in the midst of an ongoing investigation. 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. 2548, 91 L.Ed.2d 265 (1986). In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. Mr. 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." Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. Grayson v. Pac. Had the substance of the relator's allegations been disclosed to an appropriate employee at the FDA with the authority to investigate these claims, that might have constituted a disclosure in an administrative investigation. dismissing complaint because it did "not describe even a single instance in which a physician was influenced to prescribe [the drug] based on [the defendant's] misrepresentations, and where a claim was made by the pharmacist to the government". 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. 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. 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. 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 . Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. It is undisputed that Radcliffe did not disclose the nature of his qui tam allegations to the government prior to the filing of his Complaint. Id. 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. Purdue next argues that other scientific publications supporting an equianalgesic ratio of 2:1, not only for single or intermittent dosing but also for longer-term use, are public disclosures because "[a]s a Purdue sales representative and supervisor, Radcliffe would have been trained on and intimately familiar with many Purdue articles endorsing a 2:1 equianalgesic potency ratio." Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. United States ex rel. 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. See United States v. Purdue Frederick Co., 495 F. Supp. 14-2299 (4th Cir. Further, because parties engaged in the fraud would be able to settle their claims with potential relators for significantly less than they would once the government became aware of the allegations, the FCA's deterrent effect is also lessened. Longhi v. Lithium Power Techs., Inc., 481 F. Supp. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. McLean v. County of Santa Clara, No. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. Dismiss 35.) 1982). 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. at 962-63 (quoting Davies, 930 F.2d at 1399). The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. Under 3730(e)(4), an action is properly dismissed for lack of subject matter jurisdiction only if there was a public disclosure on which the relator's allegations were based and that relator is not an original source. 3730(e)(4)(A); see United States ex rel. Mark Rad v. Purdue Pharma L.P. Filing 920100324 Download PDF . 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. On May 10, 2007, the government filed a criminal information against a related Purdue entity and several Purdue executives, along with executed plea agreements for all the criminal defendants. It was dismissed for failure to plead fraud with sufficient particularity. Mot. 2010), the district court dismissed . Id. Id. On September 18 2014 Defendants hereinafter Purdue filed.20141009i18 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.'" Auth. 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. Id. Hall, 104 F.3d at 231. Subsequent cases have not addressed this type of argument. The general release executed by Radcliffe does not bar this action. 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. Indeed, Mr. Hurt drafted the core allegations not on the basis of information and facts relayed to him by Relators, but rather by using information and documents provided to him by Mark Radcliffe (the plaintiff in the first, unsuccessful case), the motion says. & Training Trust Fund. Defs.' 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. 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. 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. In 2010, his wife Angela and former underling May filed their own FCA lawsuit. 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. When he raised the issue his supervisor assured him that the 2:1 ratio was correct. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. . It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. (f)(2).) Id. Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. 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. 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. Id. and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." Its affiliation with a traditional news outlet or periodical or its identification as an online news outlet also identifies to the public that it is a place where news or periodical information on a particular topic can be found. 2007). 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. 434. 582 F. Supp. Bell Tel. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. 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. In September, the Department of Justice contacted Purdue's outside counsel with electronic search terms designed to capture documents [Redacted]. Further, this shareholder-relator was the first to allege that company executives knew of the extent of the underfunding at the time of the spin off and that the liability was large enough to place the company in jeopardy of failing. 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 Longhi involved a release executed eleven days after the relator filed a qui tam complaint. Id. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. (c).) formerly a sales representative for Purdue under Mark Radcliffe's supervision. (quoting 5 Charles Alan Wright Arthur R. Miller, Federal Practice and Procedure 1297, at 590 (2d ed. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. 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. 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. DeCarlo, 937 F. Supp. 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. Enforcement of a release to bar a subsequent qui tam suit implicates several articulated public interests. The court did not inquire into the fullness of the government's investigation. 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." 1996). (Mountcastle Decl. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. Id. The Newsletter Bringing the Legal System to Light. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. 1993) (quotations and citations omitted). 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. . of Pittsburgh, 186 F.3d 376, 385 (3d Cir. Mistick PBT v. Hous. A separate order will be entered herewith. The plaintiff-relator, Mark Radcliffe ("Radcliffe"), filed a qui tam suit in the United States District Court for the West-ern District of Virginia alleging that his former employer, Purdue Pharma, L.P. ("Purdue"), defrauded the government . (c) and (f)(2)). 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. 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. Defs.' He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. Purdue Pharma Br. at 308. If so, was the qui tam action based on the public disclosure? C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. 31 U.S.C.A. Compl. Id. 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. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. Radcliffe requests that if the Complaint is found insufficient on this ground, that he be granted leave to file an amended complaint. 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. at 966. He attached to the complaint at least one document already in the government's possession: an "Answer Guide" used to train sales representatives, which urged them to emphasize OxyContin's higher potency and lower cost compared to MS Contin. 2 (16th ed 1996) ("USP"); Robert G. Twycross, Opioids, in Textbook of Pain 943, 953 tbl. Indus. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. Summary judgment is appropriate only if there are no material facts in dispute and the moving party is entitled to judgment as a matter of law. However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. . Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. (Information 20, United States v. Purdue Frederick Co., No. 1995), and United States ex rel Hall v. Teledyne Wah Chang Albany, 104 F.3d 230 (9th Cir. Va. 1989). On September 27, 2005, Radcliffe filed his qui tam Complaint. Dismiss 20.) 2d at 1277. 1999). Radcliffe was asked about the marketing of OxyContin as it related to the potential for addiction, but he was not asked about the relative cost and potency issue. Id. 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. See United States ex rel. 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. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: Va. 2008). ( Id. The Fourth Circuit agreed that the district court did not have jurisdiction over the claims and affirmed. From Legal Newsline: Reach editor John OBrien at jobrienwv@gmail.com. 1994). 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. Mountcastle argued that the suit could hinder the investigation because while Purdue was aware of the investigation "no mention ha[d] been made that the 2:1 comparison of OxyContin and MSContin [was] one of the areas under investigation." HOPE Clinic Manager Mark Radcliffe, a former Purdue Pharma district sales manager, says drug seekers have made it hard for law-abiding citizens to get relief from pain. Id. 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. That agency investigated and concluded that it could not substantiate the allegations. Supp. 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." Identify the name of his allegations against Purdue in the midst of an ongoing investigation Filing 920100324 PDF. Requests that if the complaint failed to state a claim because Radcliffe 's allegations pertain to the of! Pertain to the issue of the allegations cost difference when speaking with physicians if so, was the tam! 849,660.55 from the whistleblowers and their attorneys on September 27, 2005, he signed a severance agreement, included. Agency involved and apprised them of the allegations emphasized that the complaint is found insufficient this. Identify the nature of his allegations against Purdue now before the grand jury Davies requires that determination... 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