Defs.' 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. In this qui tam action, the defendants have moved to dismiss on several grounds, including the jurisdictional bar based on prior public disclosures of the alleged false claims, the execution of a pre-filing general release by the relator, and a failure to plead fraud with particularity under Rule 9(b). Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . Purdue objects, but I find no cognizable basis for denying Radcliffe's request. 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]. 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."). C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. 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. They say it is a reflection on the decline of civility in the legal profession. Id. Whitten v. Triad Hosps., Inc., No. at 969. Id. But that is not sufficient to meet the rigorous standard of Rule 9(b). Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. For the purposes of addressing the public disclosure issue, the Complaint and the Third Amended Complaint contain the same claims and neither party has indicated that any relevant public disclosures were made between the date the Complaint was file and the date that the Third Amended Complaint was filed. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). The court stated that the defendant "informed the [NRC] of Hall's concerns," but it does not necessarily follow that in doing so Hall was identified to the NRC. A separate order will be entered herewith. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. The Fourth Circuit follows a three-step approach in determining whether the public disclosure bar applies. 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. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. He alleged a fraudulent scheme whereby Purdue marketed Modification of these search terms occurred in December, 2005. U.S. ex Rel. Va. 2008). McLean v. County of Santa Clara, No. Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. Disclosures made in other public forums do not implicate the public disclosure bar. (Mountcastle Decl. One of their attorneys is Mark 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." To the extent that Radcliffe based the allegations in his Complaint on either the published abstract or the published article, these constitute public disclosures in the news media. 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. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. 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 . 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. Rabushka v. Crane Co., 40 F.3d 1509, 1512-14 (8th Cir. Co., 142 Cal. Specifically, in his sales representative training, he alleges that he was taught that there was a 2:1 equianalgesic ratio between OxyContin and MS Contin, a rival pain medication containing morphine, making OxyContin twice as potent and, as a result, cheaper per dose than MS Contin. 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.'" 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. Mr. (Mountcastle Decl. Id. 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 . at 820. See United States ex rel. ( Id. Of course, it is plausible that a physician would be so induced by false representations concerning OxyContin's relative potency to write a prescription, ultimately paid for by the government. 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. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 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. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians. 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. It has been held that disclosures made directly to relevant government officials, rather than to the public, can constitute public disclosures in administrative investigations when the disclosure is made "to a competent public official" "who has managerial responsibility for the very claims being made." The facts surrounding this defense have been developed in the summary judgment record. 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. He relies on United States ex rel. Hall involved an employer who had been accused of fraud on the government by an employee. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. (Defs.' In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. The three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. of Pittsburgh, 186 F.3d 376, 385 (3d Cir. The amended complaint does not contain allegations that connect the dots for even a single alleged false claim Berger wrote. Both were published in scientific periodicals. Pharmacol. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. 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. 1999); Rabushka, 40 F.3d at 1514. Dismiss 11.) The government's investigation continued and on December 5, 2005, AUSA Mountcastle moved to stay Radcliffe's qui tam suit pending the government's ongoing investigation. at 963. These include the public interest in having relators disclose inside information of alleged fraud to the government, in having relators supplement federal enforcement of the FCA by assisting the government in its investigation and prosecution or prosecuting the claim itself, and in deterring future fraud against the government. Springfield Terminal Ry. Green, 59 F.3d at 956. Id. 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. 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 . 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. Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. 425, 428 (1999). Purdue cites United States ex rel. of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. Id. at 1043-46. The state court action resulted in a settlement and general release, which was executed more than a year after the agency had completed its investigation. 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. 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. Supp. ), aff'd, 53 F. App'x 153 (2d Cir. 3d ed. In addition to ruling the whistleblowers failed to sufficiently plead their allegations, Berger also found that their suit was barred by a rule that says whistleblowers cant bring suit over information that has already been made public. The court did not inquire into the fullness of the government's investigation. Longhi involved a release executed eleven days after the relator filed a qui tam complaint. Mark Radcliffe, 59, of Shady Spring, was convicted following a three-day jury trial. 763 (E.D. Id. Dismiss, Exs. at 818. 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. Doyle v. Diversified Collection Services, Inc., No. Defs.' Further limited discovery and briefing was allowed as to that issue. The FCA provides that there is no subject matter jurisdiction in a case where the claim is. 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. 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. 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. 1990)). (Mem. All reasonable inferences are "viewed in the light most favorable to the party opposing the motion." 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. Purdue argues that Radcliffe was a bad actor who waited to file his qui tam complaint and, prior to doing so, attempted to settle with Purdue in exchange for an investment in a company he was starting. When he raised the issue his supervisor assured him that the 2:1 ratio was correct. 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, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. Treating all allegations as true, patients may have received less effective pain relief, but it is far from clear that the government paid more money.. the baton" and file the qui tam action against Purdue now before the court. Id. 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. 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. The package insert is currently posted to a section of Purdue's web page devoted to package inserts. 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 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. 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.. 2d 939, 949 (N.D. Ill. 2004), which held that newspaper articles published in Greek in the Greek press did not constitute disclosures to the American public. Green, 59 F.3d at 962 (quoting Davies, 930 F.2d at 1396). However, that is not the situation before me. 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. 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. Longhi v. Lithium Power Techs., Inc., 481 F. Supp. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. 49.7 (Patrick D. Wall Ronald Mezack eds. It is not entirely obvious why the Ninth Circuit concluded that a full investigation negates the public interest in having a qui tam supplement federal enforcement, which includes not only disclosing information to the government, but also potentially investigating and prosecuting the case on behalf of the government. (Information 20, United States v. Purdue Frederick Co., No. 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. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). United States ex rel. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. 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." at 1512. In the conclusion of the response, the attorneys say Purdues allegations of bad faith and its personal attack on them are a lamentable tactic used to get an advantage in litigation. 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. 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. 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. 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, 1994). While the court reasoned that the enforceability of the release should be governed by federal law because it arose under federal law, the court did not address any of the public policy concerns associated with qui tam suits or the FCA. 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. In Virginia Impression Products, which was decided before Green and also before Rumery, the Fourth Circuit chose to enforce a release to bar a subsequent antitrust claim. 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. 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. 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. . Dismiss 20.) Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. . For convenience, references herein to the "Complaint" shall include the most recent version. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. Purdue Pharma is represented by John Hoblitzell III and Rebecca Betts of Kay Casto & Chaney in Charleston, W.Va., and Christopher Babbitt, Howard Shapiro and Charles Speth of Wilmer Cutler Pickering Hale & Dorr in Washington, D.C. On Oct. 31, Berger granted Purdue Pharmas motion to dismiss the lawsuit filed by Steven May and Angela Radcliffe, the wife and former coworker of the earlier whistleblower who have appealed the ruling. Purdue argues that the 2:1 ratio was correct ), aff 'd, 53 F. app x... Updated material on a periodic basis Operative or medical Procedures and Trauma, app him the. At 1514 a case where the claim is on the government on notice,,! ; Celotex Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 ( 4th Cir of! Of Am., Inc., 992 F.2d 55, 58 ( 4th Cir is no subject matter jurisdiction in case. 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