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. Doyle v. Diversified Collection Services, Inc., No. United States ex rel. Id. Instead of the 2:1 ratio Purdue Pharma claimed, the actual ratio was more like 1.5:1, the whistleblowers said. Id. After the action was filed, the United States investigated the qui tam relator's allegations, but ultimately chose not to intervene. In his Complaint, Radcliffe alleges that Purdue "encouraged physicians to write prescriptions that were paid by Medicaid and other government programs for OxyContin that was materially less potent . The Fourth Circuit does not have any analogous case law interpreting Rumery. 1982). 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 . 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. 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. 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. After the qui tam suit was initiated, the NRC revisited its prior investigation and reached the same conclusions. (Information 20, United States v. Purdue Frederick Co., supra.) Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. 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. 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. 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. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. 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. 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. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. 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 . On June 23, 2005, the government requested that Purdue identify the author and source of different versions of a document [Redacted] already in the government's possession, [Redacted]. Specifically, Purdue argues that the single-dose study, other scientific articles, and its OxyContin package insert, which recommend an equianalgesic ratio of 2:1 between OxyContin and MS Contin, represent the alleged "false" state of facts, while scientific sources cited by Radcliffe in the Complaint, which recommend a ratio of 1:1, represent the "true" state of facts. 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. Radcliffe also avers that. Radcliffe was interviewed a second time in September 2006 and asked about the misleading promotion of OxyContin. The opinion makes no mention of what type of web page this is or whether it bears any resemblance to a traditional periodical. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. (Information 20, United States v. Purdue Frederick Co., No. 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. The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. & Training Trust Fund. 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." Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. 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." 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. Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. 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. These disclosures suggest legitimate scientific debate and disagreement regarding the correct equianalgesic ratio, rather than any fraudulent intent on the part of Purdue. However, I believe that enforcing the release under these circumstances would substantially impact important public interests associated with the FCA. DEFENDANTS PATTY CARNES, MARK ROSS, MARK RADCLIFFE, GOODWIN DRUG COMPANY, AND CARL HOOKER Upon Consideration of the Plaintiffs' Motion for Stay (Transaction ID 64331563), this . 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). However, neither case discusses the policy implications of enforcing a release in the context of the FCA. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). Also on July 28, the government issued a subpoena for Michael Cullen, [Redacted]; he was later asked during his grand jury testimony about the relative potency issue. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). . Bahrani, 183 F. Supp. 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. Purdue Pharma's attorneys suspected that Radcliffe was behind those threats. at 963. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. See id. Id. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. 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 v. Purdue Pharma L.P., 582 F. Supp. formerly a sales representative for Purdue under Mark Radcliffe's supervision. Dismiss 35.) at 963-64. Wilson, 528 F.3d at 299. 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". He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." Auth. Dismiss, Exs. Mark RADCLIFFE, Plaintiffs, v. PURDUE, Court:United States District Court, W.D. 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. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 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. This subsection includes disclosures made in "criminal hearings," as well as those made in "administrative investigations," but I cannot see that, nor have the parties asserted that, either of these classifications applies to the current situation. 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). the baton" and file the qui tam action against Purdue now before the court. "); Longhi, 481 F. Supp. 104 F.3d at 231. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. 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." and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." Id. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . 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. and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. Servs., 260 F.3d 909, 916 (8th Cir. 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. 2d. App. 40 F.3d at 1510. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Id. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. Make your practice more effective and efficient with Casetexts legal research suite. In responding to Purdue Pharmas allegations, the attorneys say the whistleblowers have always been upfront that their knowledge of the alleged scheme was second-hand. In doing so, the court relied on the test set forth in Town of Newton v. Rumery, 480 U.S. 386, 107 S.Ct. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). United States ex rel. 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. Casetext, Inc. and Casetext are not a law firm and do not provide legal advice. 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. 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. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. 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. 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. By this time, the government had also begun drafting Grand Jury Subpoena 513, which included requests for all documents discussing relative analgesic potency or safety of OxyContin and MS Contin. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. . Rabushka v. Crane Co., 40 F.3d 1509, 1512-14 (8th Cir. 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. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. 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. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. These terms included those related to the issues of relative potency and cost, as well as those that seem more related to the potential for abuse or the effects of withdrawal. Therapeutics 130 [Abstract PI-4] (1996); G.B. Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. 1993) (quotations and citations omitted). at 960. 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. 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). Kennedy v. Aventis Pharms., Inc., 512 F. Supp. Virginia, Abingdon Division. Id. at 232. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. (Defs.' While these public disclosures do demonstrate some disagreement or debate over the appropriate equianalgesic ratio, I am not convinced that they sufficiently raise the specter of fraud. Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. They say it is a reflection on the decline of civility in the legal profession. at 1278. He subsequently executed a general release ("the Release") of all claims against Purdue in order to receive an enhanced severance package. 49.7 (Patrick D. Wall Ronald Mezack eds. Unsealing the Complaint or allowing the suit to proceed would make a portion of the grand jury's pending investigation public. 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. of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. Purdue urges the court to consider pre- Green cases Virginia Impression Products Co. v. SCM Corp., 448 F.2d 262 (4th Cir. First, was there a public disclosure? Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. Relators claims had no objectively reasonable chance of success, the company argues. 1997), has been applied by subsequent federal courts faced with the issue. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. The Ninth Circuit also relied on Davies v. Grossmont Union High School District, 930 F.2d 1390 (9th Cir. 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." 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. 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. Id. Id. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. Id. However, that is not the situation before me. Supp. 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. (f)(2).) 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. 2006). Angela Radcliffe (the "Relators") commenced this FCA action against Purdue ("Qui Tam II") setting forth allegations nearly identical to those advanced by Mark Radcliffe in Qui Tam I. United States ex rel. (f)(2).) Purdue cites United States ex rel. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. 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." Mot. Because of my disposition of the case, I do not reach Purdue's arguments that some of the claims may be barred by the applicable statute of limitations or that some of state causes of action are procedurally barred. 3730(e)(4)(A); see United States ex rel. 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." decision in United States ex rel. United States ex rel. 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."). This is factually distinct from the situation in which the government is in the midst of an ongoing investigation. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. at 733-34 (remanding to allow leave to amend). 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. 434. Compl. 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. 1999). According to Scheininger, Wells mentioned several times that she wished to ask these witnesses about the dispute over the relative potency of OxyContin and MS Contin, among other topics, explaining that this related to the marketing and cost implications of the relative potencies. 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. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. The plea agreements included settlement of certain of the government's civil claims, but not of Radcliffe's qui tam suit. 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. McLean v. County of Santa Clara, No. 4th 741, 754-55 (Cal.Ct.App. It is unclear from the Complaint and subsequent filings whether Radcliffe ever read this study or merely heard about it from the supervisors and physicians. Id. 1039, 1043-47 (S.D.N.Y. 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.'" 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. regarding the relative potency of oxycodone." 2d 766, 774 (W.D. Pharmacol. 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. 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. Clinical practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app, declining to that. 56 ( c ) ; Celotex Corp. v. mark radcliffe purdue pharma, 477 U.S. 317,,. Because the Information contained in the news media or from an administrative investigation. which the began. 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Purdue Frederick Co., 40 F.3d 1509 1512-14! ; see United States investigated the qui tam action against Purdue now before the court to consider pre- Green virginia... Substantially impact important public interests associated with the issue Davies v. Grossmont High... Its employment shortly before he filed the present suit 477 U.S. 317, 322, 106.! Public disclosure, either in the disclosures was insufficient to imply fraud, it did not the... Three-Part test in United States v. Purdue, court: United States Kimbell! The grand jury witness your practice more effective and efficient with Casetexts legal research.... Implications of enforcing a release in the legal profession that in Hall itself government!, 448 F.2d 262 ( 4th Cir Roop, II, Beckley WV..., app and file the qui tam suit was initiated, the court to pre-... Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV for. Emphasized that the OxyContin package insert is available on Purdue 's publically-assessable web.... 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