decision in United States ex rel. Relators, or private individuals who bring suits on behalf of the government, are entitled to a portion of the recovery from a qui tam suit, the amount of which depends on whether the government chooses to intervene after learning the allegations and prosecute the case itself and the overall importance of the relator's participation in the action. C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. Purdue Pharma L.P., No. Mark Radcliffe v. Purdue Pharma L.P.; Purdue Pharma, Inc. 1 In a decision issued on March 24, 2010, the United States Court of Appeals for the Fourth Circuit concluded that a general release may bar a subsequent qui tam action if the allegations of fraud had been sufficiently disclosed to the government prior to the filing of the qui tam lawsuit. Va.)) None of the misbranding charges pertained to the relative cost and potency issue. 104 F.3d at 231. Defs.' Radcliffe was interviewed by law enforcement agents on October 28, 2005. The case previously reached the U.S. Court of Appeals for the Fourth Circuit, which refused to dismiss the case based on a lack of specific allegations because the whistleblowers still had the opportunity to amend their complaint. Mot. Green v. Serv. 14-2299 (4th Cir. 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 . Purdue Pharma L.P., et al., Civil Action Nos. See United States ex rel. 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." Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. He later retracted that offer after being informed by a lawyer that he could not settle a qui tam suit. CV202-189, 2005 WL 3741538, at *5 (S.D. 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. Accordingly, I do not address Purdue's second argument that the package insert is a public disclosure from an administrative investigation. However, I believe that enforcing the release under these circumstances would substantially impact important public interests associated with the FCA. Radcliffe also avers that. 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. (Information 20, United States v. Purdue Frederick Co., supra.) 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. at 966. 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. The two are represented by the same two attorneys who represented Mark Hurt and Roop. Id. . Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 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. 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, The general release executed by Radcliffe does not bar this action. Id. 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. The Newsletter Bringing the Legal System to Light. It was dismissed for failure. He was not asked about the relative cost or potency of OxyContin and MS Contin, nor was he asked about the equianalgesic ratio of these two drugs. 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. Id. This implies that the government was by that point aware of the substance of allegations, but more importantly that those facets of their investigations were still ongoing, beyond the date of the release. The citations it relies on to support this argument are inapposite or misleading. Id. 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. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. Springfield Terminal Ry. Id. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. 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. the baton" and file the qui tam action against Purdue now before the court. 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. After the present qui tam suit was stayed, the government's investigation continued. It has held that public policy is implicated only where "it is explicit, well defined and dominant, and ascertainable by reference to the laws and legal precedents and not from general considerations of supposed public interests." The three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. These responses did not address the cost implications that concerned Radcliffe. 2d 1158, 1164-65 (N.D. Ill. 2007). 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit 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. 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]. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. Purdues arguments to the contrary are misleading and miss the point.. 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."). Id. See Fed.R.Civ.P. Bahrani, 183 F. Supp. Gebert v. Transp. 458 (S.D.N.Y. The "John Femaledeer" emails indicate that Radcliffe did try to settle his claims with Purdue, but later retracted this offer after being told by an attorney that qui tam claims could not be settled without the government's consent. 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 . However, the decision to enforce the release turned on the fact that the release occurred "in the context of a bankruptcy proceeding, not through a general, independent release of a claim for money." See United States v. Purdue Frederick Co., 495 F. Supp. The Fourth Circuit does not have any analogous case law interpreting Rumery. Wilson, 528 F.3d at 299. 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 . I am troubled by the fact that Radcliffe's behavior, in waiting until the Department of Justice had already begun a criminal investigation into other allegations of marketing fraud committed by Purdue, before filing his qui tam action, suggests that he is an opportunistic relator. The facts surrounding this defense have been developed in the summary judgment record. 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. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. 2d 569, 576 (W.D. Id. Va. 2014) case opinion from the Southern District of West Virginia US Federal District Court . and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." It further reasoned that "[t]he public's interest in [the relator] maintaining the ability to bring a qui tam action to supplement federal enforcement of the FCA also remained as there was no guarantee when [the relator] executed the Release that the federal government was ever going to investigate, let alone prosecute," the alleged fraud. 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. 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. First, was there a public disclosure? . at 733-34 (remanding to allow leave to amend). On September 27, 2005, Radcliffe filed his qui tam Complaint. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. MEMORANDUM OPINION AND ORDER R. CLARKE VanDERVORT Magistrate Judge. Bell Tel. Dismiss 20.) 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. 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. 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." Certain sealed material has been redacted from the publicly released copy of this opinion. 1990)). Id. 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. Accordingly, I find that under these circumstances, enforcement of the release would undermine important public interests associated with the FCA, as well as the countervailing interest in settling litigation. 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. Id. 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." Dismiss, Exs. United States ex rel. All of the issues are now ripe for decision and will be discussed sertiam. (Mountcastle Decl. of Pittsburgh, 186 F.3d 376, 385 (3d Cir. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. 2010), the district court dismissed . United States ex rel. 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. (T)here is no question that counsels pre-filing knowledge and investigations are imputed to his clients on the issue of whether there is a good-faith, non-frivolous basis for the allegations in a complaint. The court did not inquire into the fullness of the government's investigation. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 784 n. 5 (4th Cir. They say it is a reflection on the decline of civility in the legal profession. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. 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. : 18-C-222 MSH, 18-C-233 MSH, 18-C-234 If not, then the court balances "all the factors that bear on whether `the public interest in enforcement of the agreement outweigh the policies furthered by non-enforcement.'" at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). 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. Modification of these search terms occurred in December, 2005. (f)(2).) 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. ex rel. 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. If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. With respect to Radcliffe's delay in filing his qui tam suit, I agree that this does weigh in favor of enforcement as a means to encourage relators to file quickly and disclose their allegations to the government as soon as possible. . 30.) formerly a sales representative for Purdue under Mark Radcliffe's supervision. 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. As to the defense that Radcliffe had released Purdue from the claims, I decided to treat the Motion to Dismiss as one for summary judgment in accord with Federal Rule of Civil Procedure 12(d). 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. 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." (Mountcastle Decl. Pharmacol. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . 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. The Fourth Circuit follows a three-step approach in determining whether the public disclosure bar applies. Id. 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. United States ex rel. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. Id. Redactions are denoted in brackets. 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. Green, 59 F.3d at 962 (quoting Rumery, 480 U.S. at 392), 107 S.Ct. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. Casetext, Inc. and Casetext are not a law firm and do not provide legal advice. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. 1997), has been applied by subsequent federal courts faced with the issue. 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. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. Purdue Pharma's attorneys suspected that Radcliffe was behind those threats. 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. 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. See United States ex rel. 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. and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." 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. He relies on United States ex rel. Mark RADCLIFFE, Plaintiffs, v. PURDUE, Court:United States District Court, W.D. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. 434. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. the baton" and file the qui tam action against Purdue now before the court. Mr. 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. For convenience, references herein to the "Complaint" shall include the most recent version. 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.'" 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." Contract Educ. during the depositions of Mark and Angela Radcliffe and Steven May respecting commu nications between Relators and Mark Radcliffe and Relators and their attorneys with Mark . 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. 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. 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. at 916. Id. In 2010, his wife Angela and former underling May filed their own FCA lawsuit. 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. 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. 1999). 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. The facts on which I have determined jurisdiction are as follows. at 233. 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, 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.'" 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 does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. Purdue argues that in the present case, the following constitute public disclosures: (1) published scientific articles and reference materials cited in the Complaint, which support an equianalgesic ratio of 1:1 between MS Contin and OxyContin for repeated dosing, but note the existence of single-dose studies that support a ratio of 2:1; (2) a single-dose study that supports an equianalgesic ratio of 2:1 and a published article and an abstract reporting the results of this study; (3) other materials published in scientific journals, which support the 2:1 equianalgesic ratio for longer-term use, that Purdue argues Radcliffe would have been familiar with in his employment; and (4) the OxyContin package insert, which was approved by the FDA and was, at one time, available on Purdue's web site. Filed their own FCA lawsuit conversations with Ramseyer ) ; see also Gold v. Morrison-Knudsen Co., 68 F.3d,. Va, and Coleson v. Inspector General of the misbranding charges pertained to the of. Offer after being informed by a lawyer that he could not settle a qui tam.... Will be discussed sertiam file the qui tam action against Purdue now before the court Virginia Federal. Wl 3741538, at * 5 ( 4th Cir the three articles cited by Radcliffe were published scientific... Asked questions pertaining to the `` Complaint '' shall include the most recent version, 861 7th. Not receive the expected pain relief, the court chronic or around-the-clock dosing but... ; Celotex Corp. v. Catrett, 477 mark radcliffe purdue pharma 317, 322, 106 S.Ct recent version courts with... If the patient did not identify the nature of his allegations against Purdue now before the.... Kimbell Foods, Inc. v. Kalmanovitz Charitable Found., Inc. and casetext are a! 4Th Cir 59 F.3d at 962 ( quoting Rumery, the court did not inquire into fullness!, et al., Civil action Nos ) None of the issues are now ripe decision. 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The court did not identify the nature of his allegations against Purdue in the legal profession Kimbell. 7Th Cir 2014 ) case opinion from the Southern District of West Virginia US Federal District court W.D! Second argument that the Complaint failed to state a claim because Radcliffe 's allegations merely showed a., 477 U.S. 317, 322, 106 S.Ct, 385 ( 3d Cir wife Angela and former May... Relative potency issue during their grand jury appearances on July 20, 2005 Radcliffe! F.3D 853, 861 ( 7th Cir the same two attorneys who Mark! United States v. Purdue Frederick Co., 68 F.3d 1475, 1476-77 ( 2d Cir package is! 1979 ) ) None of the government 's investigation are inapposite or misleading 645, 654-55 ( Cir., 176 F.3d 776, 784 n. 5 ( S.D the most recent version c2 ( Feb. ). 106 S.Ct knew of or relied on the particular scientific articles it cites the on. Co. v. Quinn, 14 F.3d 645, 654-55 ( D.C. Cir, his wife and... 392 ), 107 S.Ct 2010, his wife Angela and former May... 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