at 818. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. Matsushita Elec. The citations it relies on to support this argument are inapposite or misleading. 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. . 1997), has been applied by subsequent federal courts faced with the issue. See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. These responses did not address the cost implications that concerned Radcliffe. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: Instead of the 2:1 ratio Purdue Pharma claimed, the actual ratio was more like 1.5:1, the whistleblowers said. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319, 321-22 (4th Cir. While the prior public disclosures included information that was true, they did not reveal the "true" state of facts regarding the executives' knowledge or intentions. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. Although the 2001 posting of the OxyContin package insert could be considered either a corporate report or a press release, because it was posted on a web page entitled "News What's New" and because other items on the page resemble press releases, I will consider the OxyContin package insert a public disclosure in the news media. 5:2010cv01423 - Document 191 (S.D.W. Dismiss 11.) 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. Contract Educ. 1999); Rabushka, 40 F.3d at 1514. It is undisputed that Radcliffe did not disclose the nature of his qui tam allegations to the government prior to the filing of his Complaint. 2d at 774. Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. 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. Purdue cites United States ex rel. Subsequent cases have not addressed this type of argument. 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. Rabushka v. Crane Co., 40 F.3d 1509, 1512-14 (8th Cir. 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. For convenience, references herein to the "Complaint" shall include the most recent version. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. at 1513-14. 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. Protected by Google ReCAPTCHA. On Nov. 17, the company moved to have the plaintiffs pay its legal fees under the fee-shifting provisions in the FCA. 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. A separate order will be entered herewith. Id. Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). Radcliffe v. Purdue Pharma, L.P., 562 U.S. 977 (2010), his wife Angela decided to "take up . But that is not sufficient to meet the rigorous standard of Rule 9(b). 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." He alleged a fraudulent scheme whereby Purdue marketed 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. The package insert is currently posted to a section of Purdue's web page devoted to package inserts. 1:07-CR-00029 (W.D. Id. (Information 20, United States v. Purdue Frederick Co., No. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. "); Longhi, 481 F. Supp. One of their attorneys is Mark 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 . 2d 1158, 1164-65 (N.D. Ill. 2007). Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . at 233. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. J.A. Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. Once it decided to fashion a uniform rule on the enforceability of pre-filing releases, the Ninth Circuit turned to Rumery, 480 U.S. at 392, to structure its discussion of competing policy concerns. 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. The court found no statutory or policy reasons to prevent enforcement of the release. Hall, 104 F.3d at 231. Dismiss 20.) After the present qui tam suit was stayed, the government's investigation continued. 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. at 965-66. 104 F.3d at 231. Id. While Purdue concedes that a defendant may be liable for inducing a third party to submit a false claim to the government, it argues that Radcliff's allegations do not meet the Rule 9(b) pleading requirements because he does not describe even a single instance in which a physician was influenced to prescribe OxyContin based on Purdue's misrepresentations, and where a claim for payment was made by the pharmacist to the government. Although the criminal charges did relate to the misbranding of OxyContin, these charges focused on Purdue's marketing of OxyContin as "less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications." Redactions are denoted in brackets. 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, On August 1, 2005, he signed a severance agreement, which included a general release of all claims against Purdue. See id. Va. 1989). Thus, I find that these constitute public disclosures in the news media. Purdue does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. Ultimately, the Ninth Circuit found that the significant public interests at issue when a potential relator and potential defendant execute a release, without the government's knowledge or consent, prior to the filing of a qui tam complaint outweighed the general interest in settling litigation and determined that, as a rule, such pre-filing releases were not enforceable to bar the subsequent qui tam actions. DeCarlo, 937 F. Supp. Id. Id. 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. at 231-32. ex rel. App. It has been noted that "[c]ourts have applied Rumery to a broad spectrum of pre- and post-filing releases of qui tam claims entered into without the United States' knowledge or consent." 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). L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. Bahrani, 183 F. Supp. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians. Because the information contained in the disclosures was insufficient to imply fraud, it did not trigger the jurisdictional bar. The two are represented by the same two attorneys who represented Mark Hurt and Roop. 1991), which builds upon the Rumery test. 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. Will be used in accordance with our terms of service & privacy policy. 49.7 (Patrick D. Wall Ronald Mezack eds. Modification of these search terms occurred in December, 2005. Dismiss, Exs. If a substantial public interest would be impaired, the court need not engage in the Rumery balancing test unless there is an articulated reason favoring enforcement aside from the "`interest in the settlement of litigation,'" as that "`cannot by itself outweigh a substantial public interest on the other side of the scales.'" 14-2299 (4th Cir. 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. 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. 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit . This is factually distinct from the situation in which the government is in the midst of an ongoing investigation. The package insert recommends a starting conversion rate between OxyContin and MS Contin of 2:1, which can be reassessed based on a patient's reaction to the dosage. . Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. 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. 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