mark radcliffe purdue pharma

434. 40 F.3d at 1510. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. United States ex rel. CV202-189, 2005 WL 3741538, at *5 (S.D. 2001); United States ex rel. 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 . These disclosures suggest legitimate scientific debate and disagreement regarding the correct equianalgesic ratio, rather than any fraudulent intent on the part of Purdue. at 956-57. 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. Purdue contends that Radcliffe released the claim made in his Complaint in the course of a settlement agreement with Purdue when he left its employment. 2016) Annotate this Case Justia Opinion Summary Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. Dismiss, Exs. 09-1202 (4th Cir. United States of America, et al. & Training Trust Fund. After the qui tam suit was initiated, the NRC revisited its prior investigation and reached the same conclusions. Servs., 260 F.3d 909, 916 (8th Cir. 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. Make your practice more effective and efficient with Casetexts legal research suite. Id. Purdues arguments to the contrary are misleading and miss the point.. Decided: January 29, 2016. Id. Joining her as a relator is Steven May, a former Purdue employee who worked under Mr. Radcliffe. Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. Wilson v. Graham County Soil Water Conservation Dist., 528 F.3d 292, 309 (4th Cir. Id. Supp. 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. In January and February of 2005 Radcliffe sent emails to several officers and directors of Purdue, using the alias "John Femaledeer." 1994) ("Textbook of Pain"). The Ninth Circuit determined that enforcement of the release would impair the public interest by diluting incentives to file qui tam suits, thus making the government less likely to learn of the alleged fraud, and by diluting the FCA's deterrent affect. In his employment with Purdue between 1996 and 2005, Radcliffe was responsible for marketing OxyContin to individual physicians and became familiar with Purdue's marketing claims about OxyContin's relative cost and potency, including the claim that there is a 2:1 equianelgesic ratio between OxyContin and MS Contin. 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. 14-2299 (4th Cir. 2008). 9 n.4. 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. Id. Bell Tel. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. Its affiliation with a traditional news outlet or periodical or its identification as an online news outlet also identifies to the public that it is a place where news or periodical information on a particular topic can be found. Mistick PBT v. Hous. 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). They say it is a reflection on the decline of civility in the legal profession. 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. Doyle v. Diversified Collection Services, Inc., No. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. 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." (Defs.' Id. The case was stayed for over a year and a half until the government declined to intervene on May 8, 2007. . See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. 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. 1187. However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. 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. 30.) at 1047. To the extent that Radcliffe derived the allegations in his Complaint from either of these sources, these will be considered public disclosures in the news media. 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. United States ex rel. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. Compl. Purdue cites Gebert, 260 F.3d 909, in which the government did not investigate until after the filing of the qui tam complaint and the court ultimately chose to enforce the release. 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. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. During this period or time, the government was conducting its own comprehensive investigation into Purdue's manufacturing, marketing, and distribution of OxyContin. Radcliffe was a district sales manager for Purdue, laid off as part of a reduction in force in June 2005. MARK RADCLIFFE: Defendant - Appellee: PURDUE PHARMA L.P. and PURDUE PHARMA, INCORPORATED: Amicus Curiae: 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. at 233. However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. Nathan v. Takeda Pharmaceuticals N.A. Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. In this case, that information was the first FCA suit filed by Mark Radcliffe. Plaintiff - Appellant: UNITED STATES EX REL. Id. The plaintiff-relator, Mark Radcliffe ("Radcliffe"), filed a qui tam suit in the United States District Court for the West-ern District of Virginia alleging that his former employer, Purdue Pharma, L.P. ("Purdue"), defrauded the government . 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.'" Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. at 817. 434. Id. Based on the evidence in the present case, it is clear that the government was aware of the substance of Radcliffe's allegations and had begun, but not completed, its investigation of these allegations as of the date of the release. 2010). Mark Rad v. Purdue Pharma L.P. Filing 920100324 Download PDF . 56(e)). 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. When he raised the issue his supervisor assured him that the 2:1 ratio was correct. 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. 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. Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. Id. If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. decision in United States ex rel. 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." 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." Purdue has withdraw that argument, including its related Request for Judicial Notice. Va. 2008). The Ninth Circuit also relied on Davies v. Grossmont Union High School District, 930 F.2d 1390 (9th Cir. Id. at 821. See id. United States ex rel. The published scientific articles and reference materials cited by Radcliffe in his Complaint the Clinical Practice Guideline, the USP, and the Textbook of Pain fall within the "news media" category of 3730(e)(4)(A) and constitute public disclosures. Id. Mot. Id. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. 2d 815, 818 (S.D. Mot. 104 F.3d at 231. ex rel. 5:2010cv01423 - Document 191 (S.D.W. of Pittsburgh, 186 F.3d 376, 385 (3d Cir. Id. 1982). Gilligan v. Medtronic, Inc., 403 F.3d 386, 389 (6th Cir. 1999). Disclosures made in other public forums do not implicate the public disclosure bar. Yannacopolous v. General Dynamics, 315 F. Supp. Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. Instead both the 2001 posting and the current posting of the OxyContin package insert seem more akin to a corporate report or a press release. He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." Mr. 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.'" The two are represented by the same two attorneys who represented Mark Hurt and Roop. McLean v. County of Santa Clara, No. Both were published in scientific periodicals. Indus. 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. at 308. 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." 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. 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. See Fed.R.Civ.P. 4th 741, 754-55 (Cal.Ct.App. at 960. 1:07-CR-00029 (W.D. Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. 481 F. Supp. School escapes liability for sex abuse by teacher, Walmart launches Constitutional attack on Lina Khan's FTC, Firefighters fired over penises drawn on Black colleague's family pictures lose lawsuit, Lawsuit targets Panera's Sip Club, complains refills have restrictions, Judge stops 3M's plan to handle massive earplug litigation. Green, 59 F.3d at 959. 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. . Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. Admin. Here, it appears that the government did learn of the substance of Radcliffe's allegations independently and was interested enough in them to request documents pertaining to and question various Purdue employees about the relative cost and potency issue. During this period . ( Id. and, accordingly, less expensive than MSContin" and the accuracy of "the 2:1 comparison of OxyContin to MSContin." Id. 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. 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit First, was there a public disclosure? In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. Summary judgment is appropriate only if there are no material facts in dispute and the moving party is entitled to judgment as a matter of law. Id. at 231-32. at 1277-78. Gilligan, 403 F.3d at 389; see also Springfield, 14 F.3d at 655; United States ex rel. at 916. 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. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . regarding the relative potency of oxycodone." 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 signed a general release of all claims against Purdue in exchange for an enhanced severance package. The facts on which I have determined jurisdiction are as follows. After the present qui tam suit was stayed, the government's investigation continued. 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. at 1047. Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. Because I find that these scientific articles and the OxyContin package insert, taken together, do not disclose or imply fraud, and, thus, do not constitute a public disclosure of the allegations or transactions within the meaning of 3730(e)(4)(A), I need not address the extent to which Radcliffe based his allegations on these materials, nor whether he was an original source. The three articles cited by Radcliffe were published in scientific and medical reference periodicals that distribute new or updated material on a periodic basis. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. 1971), and Coleson v. Inspector General of the Department of Defense, 721 F. Supp. 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. Longhi v. Lithium Power Techs., Inc., 481 F. Supp. at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). Id. Therapeutics 130 [Abstract PI-4] (1996); G.B. Purdue cites United States ex rel. The package insert is currently posted to a section of Purdue's web page devoted to package inserts. "); Longhi, 481 F. Supp. Subsequent cases have not addressed this type of argument. U.S. ex Rel. (Mem. 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). I agree. 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