1982). dismissing complaint because it did "not describe even a single instance in which a physician was influenced to prescribe [the drug] based on [the defendant's] misrepresentations, and where a claim was made by the pharmacist to the government". The facts on which I have determined jurisdiction are as follows. 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 . Relators claims had no objectively reasonable chance of success, the company argues. 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. 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. 1994) ("Textbook of Pain"). 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. 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. The FCA provides that there is no subject matter jurisdiction in a case where the claim is. But see United States ex rel. 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 . As noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. 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. 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."). United States ex rel. at 963. Gebert v. Transp. Protected by Google ReCAPTCHA. On September 18 2014 Defendants hereinafter Purdue filed.20141009i18 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. The circumstances here fall within the general rule articulated in Green that pre-filing releases are unenforceable to bar subsequent qui tam actions, rather than the Hall exception, because the government had not fully investigated the substance of Radcliffe's allegations. Id. 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." Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. See Fed.R.Civ.P. App. The plea agreements included settlement of certain of the government's civil claims, but not of Radcliffe's qui tam suit. 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). at 1513. 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). The stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. 1039, 1043-47 (S.D.N.Y. The general release executed by Radcliffe does not bar this action. at 1043-46. Defs.' In this case, that information was the first FCA suit filed by Mark Radcliffe. Id. After carefully considering the arguments of the parties, I hold that the Complaint does not adequately state a claim for fraud under Rule 9(b). 1996). The parties have been provided with the sealed copy. United States of America, et al. United States v. Bank of Farmington, 166 F.3d 853, 861 (7th Cir. 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. Yannacopolous v. General Dynamics, 315 F. Supp. 434. 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. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . 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. Mot. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. 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. Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. Further, this shareholder-relator was the first to allege that company executives knew of the extent of the underfunding at the time of the spin off and that the liability was large enough to place the company in jeopardy of failing. These disclosures suggest legitimate scientific debate and disagreement regarding the correct equianalgesic ratio, rather than any fraudulent intent on the part of Purdue. Matsushita Elec. Likewise, the public interest in using qui tam suits to supplement federal enforcement of the FCA was not disturbed as the government had already investigated the allegations prior to the release. 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. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. Grayson v. Pac. . 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. The district court granted summary judgment to the defendants who argued that, as part of the release, the relator had bargained away his right to bring the qui tam suit and as a result could not demonstrate any personal stake in the outcome sufficient to satisfy Article III standing. F. Brian Ferguson. Therapeutics 130 [Abstract PI-4] (1996); G.B. Purdue Pharma is seeking $849,660.55 from the whistleblowers and their attorneys. Beginning in 2002 and continuing for the next several years, the government sought millions of documents from Purdue and conducted hundreds of interviews, some of which pertained to the relative potency and cost of OxyContin and MS Contin. 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. Id. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. 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. Radcliffe also avers that. Thus, I find that these constitute public disclosures in the news media. 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. 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. Purdue contends that, under Hall, enforcement of a release to bar a subsequent qui tam action is appropriate even if the government has not completed its investigation. to Mot. 2d 1158, 1164-65 (N.D. Ill. 2007). 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. . 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. One of their attorneys is Mark Id. See United States v. Purdue Frederick Co., 495 F. Supp. (Defs.' of Health Human Servs., Clinical Practice Guideline: Acute Pain Management: Operative or Medical Procedures and Trauma, app. Dismiss 35.) (quoting 5 Charles Alan Wright Arthur R. Miller, Federal Practice and Procedure 1297, at 590 (2d ed. 104 F.3d at 231. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. Co. v. Quinn, 14 F.3d 645, 654-55 (D.C. Cir. Because of the potential in this area for state law to impair federal rights, the possibility of forum-shopping, and the unlikeness that uniform federal rule would disrupt commercial relationships predicated on state law, the Ninth Circuit chose to craft a uniform federal rule, rather than apply state law. . The Newsletter Bringing the Legal System to Light. Wilson, 528 F.3d at 299. Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 784 n. 5 (4th Cir. Redactions are denoted in brackets. at 966. Id. 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. United States ex rel. 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." 9 n.4. These employees were indeed asked questions pertaining to the relative potency issue during their grand jury appearances on July 20, 2005. Id. 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. Several months later, Purdue restructured its sales force and Radcliffe was offered the option of transferring positions, which he declined, or termination with an extended severance package. 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. 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. Contract Educ. They amended their complaint, and again Purdue Pharma asked Berger to dismiss it. 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 . Modification of these search terms occurred in December, 2005. (Mem. 4th 741, 754-55 (Cal.Ct.App. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. Purdue does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. Id. 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. 40 F.3d at 1510. at 232. Id. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. The motion says the whistleblowers attorney, Hurt, knewthe two would take up the baton after the first FCA suit was dismissed and that the two did not have personal knowledge of the allegations of fraud they would make against Purdue, claiming they even contradicted the claims made in the complaint during their testimony. at 733-34 (remanding to allow leave to amend). Counsel also stated that on July 28, 2005, she spoke to an attorney from the Department of Justice who expressed an interest in using electronic searches to identify documents [Redacted]. 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. Id. See id. (c).) 3d ed. U.S. ex Rel. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. the baton" and file the qui tam action against Purdue now before the court. 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. C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. (Reply Supp. United States ex rel. 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). Mot. Pharmacol. The Fourth Circuit agreed that the district court did not have jurisdiction over the claims and affirmed. 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. J. Clin. 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. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). For instance, this web page could be affiliated with a news publication and, as such, would be updated regularly and would disseminate information to the public in a periodic manner. 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 . Id. Further limited discovery and briefing was allowed as to that issue. I think it is sufficient under Hall that the government know of the substance of the allegations. at 821. at 233. 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. 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. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (4th Cir. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. 56(e)). . ), aff'd, 53 F. App'x 153 (2d Cir. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. Supp. The amended complaint does not contain allegations that connect the dots for even a single alleged false claim Berger wrote. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. United States ex rel. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir. 582 F. Supp. He later retracted that offer after being informed by a lawyer that he could not settle a qui tam suit. . Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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 . 2d 569, 576 (W.D. and as a result, generally more expensive than the OxyContin that was described in [Purdue's] marketing pitch to the same physicians." 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.'" Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). United States ex rel. 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." Id. 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. Because the public disclosure bar involves the jurisdiction of the court, it must be determined first, before proceeding to any other questions. 1999). Green, 59 F.3d at 962 (quoting Davies, 930 F.2d at 1396). Tex. Subsequent cases have not addressed this type of argument. During this period or time, the government was conducting its own comprehensive investigation into Purdue's manufacturing, marketing, and distribution of OxyContin. 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. 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. 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. Plaintiff - Appellant: UNITED STATES EX REL. 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. 2d at 774. 2007). Because MS Contin and OxyContin were designed for chronic dosing, these physicians believed the 1:1 equianalgesic ratio was the appropriate one. Purdue Pharma L.P., et al., Civil Action Nos. at 962-63 (quoting Davies, 930 F.2d at 1399). 2010) case opinion from the U.S. Court of Appeals for the Fourth Circuit CV202-189, 2005 WL 3741538, at *5 (S.D. 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. Radcliffe was interviewed by law enforcement agents on October 28, 2005. United States ex rel. 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. 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. United States ex rel. 30.) Id. Mark Radcliffe, 60, of Shady Spring, was convicted in October 2016 of conspiracy to tamper with a witness following a three-day jury trial. This case briefly mentions several sources "two previously filed lawsuits against defendant, as well as an Internet web page and a Pittsburgh Post-Gazette article" and summarily concludes that "these constitute public disclosures." The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. McLean v. County of Santa Clara, No. 1994); United States ex rel. While corporate reports have been held insufficient to implicate the jurisdictional bar of 3730(e)(4)(A), Rabushka, 40 F.3d at 1514 n. 2, press releases have been deemed public disclosures within the meaning of the statute, United States ex rel. 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 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). Certain sealed material has been redacted from the publicly released copy of this opinion. Finally, if the action was based on the public disclosure, was the relator an original source? A doctor relying on the 2:1 ratio would initially prescribe half as much OxyContin as MS Contin, which, according to the relators, did cost less, Berger wrote. Mark Rad v. Purdue Pharma L.P. Filing 920100324. In Rabushka, a shareholder filed suit alleging that his conversations with company executives demonstrate that they fraudulently understated unfunded pension liability and spun off one of the company's components in order to shift responsibility for the pensions to another entity. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. After all, they were suing Purdue, not for any injuries that they had personally suffered, but for Purdues fraud against the Government, a response filed Dec. 4 says. Radcliffe signed a general release of all claims against Purdue in exchange for an enhanced severance package. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. During this period . 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. Id. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. Co., 142 Cal. Auth. Instead of the 2:1 ratio Purdue Pharma claimed, the actual ratio was more like 1.5:1, the whistleblowers said. C2 (Feb. 1992) ("Clinical Practice Guideline"); United States Pharmacopeia-Dispensing Information 2238 tbl. 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." Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Looking at the specific web page cited by Purdue, it appears that on July 18, 2001, the OxyContin package insert was posted to a section of Purdue's web page entitled "News What's New." First, was there a public disclosure? 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. 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. 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 . 14-2299 (4th Cir. 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.'" 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. 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