Id. Id. . at 961 (applying the three-part test in United States v. Kimbell Foods, Inc., 440 U.S. 715 (1979)). 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." 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.'" United States ex rel. 2d at 1278. 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. (Mem. The facts on which I have determined jurisdiction are as follows. & Training Trust Fund. Purdue Pharma L.P., No. . 481 F. Supp. . United States ex rel. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . Regardless, the 1996 abstract was published in Clinical Pharmacology Therapeutics, a scientific journal headquartered in Alexandria, Virginia. Green, 59 F.3d at 962. 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 "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. 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. It was dismissed for failure to plead fraud with sufficient particularity. Id. While the OxyContin package insert recommends the 2:1 conversion ratio as a starting point for doctors switching patients from MS Contin to OxyContin, it also suggests the need to reevaluate based on each individual patient's response to the new medication. Make your practice more effective and efficient with Casetexts legal research suite. 763 (E.D. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. 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. As a result, such a rule would reward potential defendants who encourage settlement and would impair the public interest in having relators disclose information to the government. In this action brought under the qui tam provisions of the False Claims Act ("FCA"), 31 U.S.C.A. Defs.' Id. I agree. Id. 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. at 308. 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. 1348, 89 L.Ed.2d 538 (1986) (quotations and citations omitted). United States ex rel. Id. MEMORANDUM OPINION AND ORDER R. CLARKE VanDERVORT Magistrate Judge. 2d 815, 818 (S.D. J.A. 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. 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. However, the decision to enforce the release turned on the fact that the release occurred "in the context of a bankruptcy proceeding, not through a general, independent release of a claim for money." 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. 31 U.S.C.A. at 1047. However, this applies to public policy concerns in the interpretation of a contract rather than in a determination of its validity. Contract Educ. 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. 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. 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. 2d at 774. 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. Purdue objects, but I find no cognizable basis for denying Radcliffe's request. These responses did not address the cost implications that concerned Radcliffe. In deciding a jurisdictional challenge, the court must determine the facts based on the evidence submitted. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. 1993) (quotations and citations omitted). They say it is a reflection on the decline of civility in the legal profession. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 5:2010cv01423 - Document 191 (S.D.W. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. 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. 1348 (quoting Fed.R.Civ.P. He alleged a fraudulent scheme whereby Purdue marketed at 963. Given the international nature of the scientific community, there is no indication that the publication of this article in a foreign scientific journal makes it any less accessible to the American public than if it were published in a scientific journal located in the United States. Id. Green v. Serv. F. Brian Ferguson. 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. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. 1999). Dismiss 35.) 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. Id. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. Enforcement of a release to bar a subsequent qui tam suit implicates several articulated public interests. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. 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". Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). 14-2299 (4th Cir. Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). Wilson, 528 F.3d at 299. 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. See Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. United States ex rel. 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. On August 1, 2005, Radcliffe executed a general release as part of . 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. 9 n.4. 4th 741, 754-55 (Cal.Ct.App. 1997), has been applied by subsequent federal courts faced with the issue. In September, the Department of Justice contacted Purdue's outside counsel with electronic search terms designed to capture documents [Redacted]. Id. 09-1202 (4th Cir. Radcliffe was asked about the marketing of OxyContin as it related to the potential for addiction, but he was not asked about the relative cost and potency issue. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. During the course of the agency's investigation, the employee was terminated and initiated a state court action, which did not include a qui tam claim. Admin. United States ex rel. Purdue Pharma L.P., et al., Civil Action Nos. Yannacopolous v. General Dynamics, 315 F. Supp. 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. The court found no statutory or policy reasons to prevent enforcement of the release. 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. Virginia, Abingdon Division. See id. 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." 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 . Mark Radcliffe, 59, of Shady Spring, was convicted following a three-day jury 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. United States ex rel. 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. 2002); see also Gold v. Morrison-Knudsen Co., 68 F.3d 1475, 1476-77 (2d Cir. . 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. Supp. 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. 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 . 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. 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. Taken together, these disclosures reveal disagreement in the scientific community, but do not raise an inference of fraud. at 1513. Id. Rabushka v. Crane Co., 40 F.3d 1509, 1512-14 (8th Cir. 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. However, that is not the situation before me. Relators claims had no objectively reasonable chance of success, the company argues. Finally, if the action was based on the public disclosure, was the relator an original source? Purdue does not claim definitively that Radcliffe actually knew of or relied on the particular scientific articles it cites. (c).) Bahrani, 183 F. Supp. 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. For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. (Information 20, United States v. Purdue Frederick Co., supra.) at 960. formerly a sales representative for Purdue under Mark Radcliffe's supervision. 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 Ramseyer recalls receiving a telephone call from a West Virginia attorney regarding a possible qui tam suit against Purdue at some point prior to September 27, 2005. 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. at 965-66. 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 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. But see United States ex rel. One of their attorneys is Mark 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 stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. 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. 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. As early as 1996, Radcliffe found that some of the physicians he spoke to were skeptical of this 2:1 ratio. 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. Id. Given the vast array and varying credibility of web pages on the Internet, I am not ready to conclude that anything posted online would automatically constitute a public disclosure within the meaning of 3730(e)(4)(A). (Reply Supp. Id. In his Complaint, Radcliffe references, but does not cite, a single-dose potency study that his supervisors told him supported an equianalgesic ratio of 2:1. 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. The general release executed by Radcliffe does not bar this action. 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. 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. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). Id. See United States v. Purdue Frederick Co., 495 F. Supp. 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. The qui tam provisions are designed to supplement government enforcement of the FCA by using financial incentives to encourage insiders privy to fraud on the government to disclose this inside knowledge and potentially prosecute violations. 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. 2010), the district court dismissed . 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." 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. 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. 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. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. See Agency for Health Care Policy Research, Public Health Serv., U.S. Dept. McLean v. County of Santa Clara, No. 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. at 966. Purdues arguments to the contrary are misleading and miss the point.. at 1043-46. 1995); State ex rel. Mot. 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. at 1512. The court did not inquire into the fullness of the government's investigation. 2d 569, 576 (W.D. 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. 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. 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. 434. Radcliffe also avers that. 2d. at 232. Kennedy v. Aventis Pharms., Inc., 512 F. Supp. Auth. Id. 40 F.3d at 1510. App. CV202-189, 2005 WL 3741538, at *5 (S.D. 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. United States District Court, W.D. L E Corp. v. Days Inns of Am., Inc., 992 F.2d 55, 58 (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. Protected by Google ReCAPTCHA. As to the defense that Radcliffe had released Purdue from the claims, I decided to treat the Motion to Dismiss as one for summary judgment in accord with Federal Rule of Civil Procedure 12(d). Purdue also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. See Robert F. Kaiko et al., Analgesic Onset and Potency of Oral Controlled-Release (CR) Oxycodone and CR Morphine, 59(2) Clin. 434. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. The opinion makes no mention of what type of web page this is or whether it bears any resemblance to a traditional periodical. That provision says the court may award reasonable attorneys fees and expenses if the court finds the lawsuit was clearly frivolous or vexatious or brought primarily for purposes of harassment. Servs., 260 F.3d 909, 916 (8th Cir. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. 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.. at 733-34 (remanding to allow leave to amend). 1999). Unsealing the Complaint or allowing the suit to proceed would make a portion of the grand jury's pending investigation public. 1982). He later retracted that offer after being informed by a lawyer that he could not settle a qui tam suit. 49.7 (Patrick D. Wall Ronald Mezack eds. However, to the extent that Radcliffe actually did base his qui tam allegations on these articles, these will be considered public disclosures in the news media. A separate order will be entered herewith. However, neither case discusses the policy implications of enforcing a release in the context of the FCA. 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." Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." (Information 20, United States v. Purdue Frederick Co., No. United States ex rel. If so, was the qui tam action based on the public disclosure? Radcliffe encountered skepticism from physicians he spoke with regarding OxyContin's relative cost and potency. Following Radcliffe's execution of the general release on August 1, 2005, the government's investigation continued. 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. Purdue cites United States ex rel. Va. 2008). 2010). During this period or time, the government was conducting its own comprehensive investigation into Purdue's manufacturing, marketing, and distribution of OxyContin. Alcohol Found., Inc. v. Kalmanovitz Charitable Found., Inc., 186 F. Supp. After the qui tam suit was initiated, the NRC revisited its prior investigation and reached the same conclusions. Kimbell Foods, Inc., 440 U.S. 715 ( 1979 ) ) see also Gold v. Co.... Dismissed for failure to plead fraud with sufficient particularity manager at Purdue, who its! At 960. formerly mark radcliffe purdue pharma sales representative and manager at Purdue, who left its employment shortly before he filed present... Policy reasons to prevent enforcement of the release determine the facts on which I have determined jurisdiction as... Determination of its validity general release on August 1, 2005, Radcliffe executed a release. 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