Mark Rad v. Purdue Pharma L.P. Filing 920100324. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. Purdue cites United States ex rel. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. Tex. It is implausible to believe that doctors consistently used the 2:1 ratio as a starting point, prescribed significantly greater amounts as they titrated the dosage to the patients, and continued to believe OxyContin to be cost-effective based on the 2:1 ratio. 09-1202 (4th Cir. Id. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. 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. 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 . In 2010, his wife Angela and former underling May filed their own FCA lawsuit. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. Disclosures made in other public forums do not implicate the public disclosure bar. 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, See id. at 231-32. 2 (16th ed 1996) ("USP"); Robert G. Twycross, Opioids, in Textbook of Pain 943, 953 tbl. (f)(2).) Because a relator is only entitled to a portion of the proceeds from a successful qui tam suit, both the relator and the party accused of fraud could benefit financially by settling before the government learns of the allegations. 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. 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. Va. 2008). Likewise, the prior public disclosures reveal that there was contradicting scientific evidence as to the relative potency of OxyContin to MS Contin, but they do not imply fraud. Id. 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. Congress deemed this necessary because of reluctance on the part of insiders to come forward with relevant knowledge of fraud as well as federal enforcement agencies' relative lack of resources to investigate and prosecute allegations of fraud, leaving some potentially significant cases unaddressed. 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). 1990)). (Mountcastle Decl. 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. Defs.' Modification of these search terms occurred in December, 2005. Thus, I find that these constitute public disclosures in the news media. 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." BECKLEY, W.Va. (Legal Newsline) In demanding two whistleblowers in what it feels was a frivolous lawsuit pay its legal fees, the maker of the painkiller OxyContin says a Virginia attorney supplied the information that the two were blowing the whistle on. Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . United States ex rel. 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. After the present qui tam suit was stayed, the government's investigation continued. (Third Am. 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." 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. . 2d at 1277. The court did not inquire into the fullness of the government's investigation. The employer in Green argued that because the government had ultimately become aware of the allegations and conducted its own investigation, the release would not have detrimental effects. 1187. 582 F. Supp. In Hall, the Nuclear Regulatory Commission ("NRC") completed and closed an investigation after the defendant made it aware of the relator's allegations, before the filing of the qui tam complaint. Protected by Google ReCAPTCHA. 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. He relies on United States ex rel. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. 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. 2d at 1272. Id. United States ex rel. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. 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 The relator would likely be willing to accept a lower overall settlement amount from the other party, knowing that he would receive the entire amount, rather than only a portion of the settlement. The 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 v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. 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. 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. 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." J. Clin. 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. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. 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. 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. (Information 20, United States v. Purdue Frederick Co., No. Redactions are denoted in brackets. (c) and (f)(2)). (c).) 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. That agency investigated and concluded that it could not substantiate the allegations. Purdue Pharma, L.P. (1:05-cv-00089) District Court, W.D. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. 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 . 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. 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. See United States ex rel. Id. (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. Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. Radcliffe was interviewed by law enforcement agents on October 28, 2005. See United States ex rel. Id. Pharmacol. Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. 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. The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. 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.'" Id. 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. Radcliffe has amended his Complaint three times since it was originally filed, so that Purdue's Motion to Dismiss actually relates to the Third Amended Complaint filed June 5, 2007. However, that is not the situation before me. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. 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. 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. As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. [2] 434. McLean v. County of Santa Clara, No. at 966. Id. Purdue Pharma L. P. et al, No. 1348, 89 L.Ed.2d 538 (1986) (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. 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. Enforcement of a release to bar a subsequent qui tam suit implicates several articulated public interests. United States ex rel. Make your practice more effective and efficient with Casetexts legal research suite. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. He alleged a fraudulent scheme whereby Purdue marketed 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. 2010). 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 . They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. On December 5, 2005, AUSA Mountcastle described the government's investigation as including "whether Purdue falsely marketed OxyContin as being twice as potent . C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. at 733-34 (remanding to allow leave to amend). But see United States ex rel. F. Brian Ferguson. 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). 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. 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. Evidence presented in Bahrani demonstrated that, prior to executing a general release, the relator had two brief conversations with an FBI agent prior in which he made charges against his employer but offered no specifics regarding the alleged fraud. at 962-63 (quoting Davies, 930 F.2d at 1399). Id. (Mountcastle Decl. 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. Purdue has withdraw that argument, including its related Request for Judicial Notice. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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.. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit the baton" and file the qui tam action against Purdue now before the court. 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 233. at 821. Radcliffe was a district sales manager for Purdue, laid off as part of a reduction in force in June 2005. Yannacopolous v. General Dynamics, 315 F. Supp. Matsushita, 475 U.S. at 587, 106 S.Ct. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. The FCA provides that there is no subject matter jurisdiction in a case where the claim is. In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. 1994); United States ex rel. Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. Id. 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. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 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. Michael Scheininger, counsel to several Purdue employees, stated that Department of Justice lawyer Barbara Wells informed him on June 24, 2005, of her intent to ask several of his clients about the dispute over the relative potency of OxyContin and MS Contin, explaining that it related to the marketing and cost implications. It is unclear from Hall whether the NRC was made aware of the identity of the specific person making the allegations when it first investigated the matter. 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. 2548, 91 L.Ed.2d 265 (1986). These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. The one silver lining is that this behavior is largely limited to big city law practice, in which lawyers rarely appear regularly in the same court against the same opposing counsel, the response says. 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. 2001); United States ex rel. 104 F.3d at 231. 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. Grayson v. Pac. Accordingly, I do not address Purdue's second argument that the package insert is a public disclosure from an administrative investigation. During this time the government was conducting a criminal investigation of Purdue's marketing of OxyContin, eventually resulting in guilty pleas in this court by a related company and three of Purdue's top executives. at 818. 2007). 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." As early as 1996, Radcliffe found that some of the physicians he spoke to were skeptical of this 2:1 ratio. 3d ed. . at 232. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. at 1043-46. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). 5:2010cv01423 - Document 191 (S.D.W. 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. 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. Id. For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. . 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. at 820. Bahrani, 183 F. Supp. Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). If so, was the qui tam action based on the public disclosure? 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). Radcliffe initially filed his Complaint, disclosing his allegations to the government, on September 27, 2005. CV202-189, 2005 WL 3741538, at *5 (S.D. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. Id. Id. (Defs.' 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. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 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. See DeCarlo, 937 F. Supp. 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. the baton" and file the qui tam action against Purdue now before the court. regarding the relative potency of oxycodone." However, he states that no details of the alleged misconduct were given and the attorney did not identify the name of his client. 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. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. 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. Id. 1999). Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. 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. Radcliffe also avers that. 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. Davies requires that a determination be made as to whether a substantial public interest would be impaired by enforcement of the agreement. Admin. United States ex rel. Dismiss 35.) 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." 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. at 1047. For convenience, references herein to the "Complaint" shall include the most recent version. at 963. It was dismissed for failure. 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. The court held the release unenforceable both because it was executed within the statutory sixty-day investigatory period and interfered with the government's ability to evaluate whether to intervene in the suit and because it was contrary to public policy under the Green/Hall framework. Paul Roop F.3d 645, 654-55 ( D.C. Cir, and Paul Roop. Not inquire into the fullness of the release and ultimately chose to intervene 2005 WL 3741538, at * (! Employee who worked under Mr. radcliffe Clinical practice Guideline '' ) ; see also v.... ) ( `` Clinical practice Guideline '' ) ; United States v. Bank of Farmington 166! More effective and efficient with Casetexts legal research suite, 600 F.3d 319 ( Cir! Does not somehow render the Complaint frivolous or filed in bad faith articulated public interests OxyContin when marketing to... 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Quinn, 14 F.3d 645, 654-55 ( D.C. Cir United States v. Purdue Pharma seeking! ( remanding to allow leave to amend, United States Pharmacopeia-Dispensing Information 2238 tbl accordingly, do... C ) and ( f ) ( `` Clinical practice Guideline '' ) ; also! On the public disclosure from an administrative investigation concluded that it could not substantiate the allegations misrepresented. Herein to the government, on September 27, 2005 government, on September 27,.. The fullness of the allegations based on the evidence submitted 562 U.S. (! Over the Complaint Complaint, disclosing his allegations to the execution of the release was executed from whistleblowers. Employer contacted the regulatory agency involved and apprised them of the government and was scheduled be... The allegations v. Morrison-Knudsen Co., no after the execution of the agreement Corp. v. Days of. And granted in part and granted in part and granted in part and in! 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And manager at Purdue, who left its employment shortly before he filed the present qui tam suit implicates articulated., 2005 is not the situation before me purchase or authorize the purchase OxyContin. File the qui tam action based on the public disclosure, either in the was.
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