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. 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. While these disclosures all reveal true information regarding the current state of the scientific debate, they do not reveal the "true" state of facts regarding the fraud alleged by the relator, that is, that Purdue used the 2:1 ratio despite knowing that it was inaccurate in order to mislead physicians and other decision-makers regarding the relative cost and potency of OxyContin. Bell Tel. 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. at 1043-46. 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. 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." One of their attorneys is Mark Ohio Dec. 29, 2006), for the proposition that publication on the Internet constitutes a public disclosure under 3730(e)(4)(A). Accordingly, I do not address Purdue's second argument that the package insert is a public disclosure from an administrative investigation. He alleges that this was done to induce physicians to prescribe OxyContin and other decision-makers to purchase or authorize the purchase of OxyContin. 49.7 (Patrick D. Wall Ronald Mezack eds. Enforcement of a release to bar a subsequent qui tam suit implicates several articulated public interests. 2006). He subsequently executed a general release ("the Release") of all claims against Purdue in order to receive an enhanced severance package. Purdue moved to dismiss the Relators' complaint on res judicata grounds, arguing that our decision in Radcliffe barred . One of their attorneys is Mark at 916. 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. DeCarlo, 937 F. Supp. United States of America, et al. 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]. If anything on the record suggests fraud with respect to the relative cost and potency, it is the relator's statements regarding his experiences in being trained to market OxyContin and his questioning of his supervisors about the relative potency issue, as well as the internal training materials that explained how to address the relative cost issue with physicians. 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. Id. United States ex rel. Green, 59 F.3d at 956. Id. Finally, Purdue argues that the OxyContin package insert is a public disclosure, either in the news media or from an administrative investigation. 1999). at 821. . 2010), the district court dismissed . 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. 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. 14-2299 (4th Cir. J. Clin. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. 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 . (T)here is no question that counsels pre-filing knowledge and investigations are imputed to his clients on the issue of whether there is a good-faith, non-frivolous basis for the allegations in a complaint. 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. 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 stay was lifted in late 2006, and the government chose not to intervene on May 8, 2007. That agency investigated and concluded that it could not substantiate the allegations. The Ninth Circuit also relied on Davies v. Grossmont Union High School District, 930 F.2d 1390 (9th Cir. The government began a lengthy investigation after the execution of the release and ultimately chose to intervene. Id. Id. Green, 59 F.3d at 962 (quoting Davies, 930 F.2d at 1396). 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. Tex. 09-1202 (4th Cir. . 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. If so, was the qui tam action based on the public disclosure? More than a year later, after he had executed the release, the relator was contacted by USDA investigators and at this time he provided detailed information regarding his allegations. 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. Mark Rad v. Purdue Pharma L.P., No. 2008). Together, Purdue argues, these create an implication of fraud sufficient to put the government on notice. On September 27, 2005, Radcliffe filed his qui tam Complaint. 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. 2d 1158, 1164-65 (N.D. Ill. 2007). United States ex rel. Id. Green v. Serv. 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. 2548, 91 L.Ed.2d 265 (1986). 1999); Rabushka, 40 F.3d at 1514. 1994) ("Textbook of Pain"). Mot. However, after the employee raised these concerns, the employer contacted the regulatory agency involved and apprised them of the allegations. Bahrani, 183 F. Supp. However, it is also clear from the evidence that the government continued to seek such information after the release had been executed on August 1, 2005. the baton" and file the qui tam action against Purdue now before the court. 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. After the qui tam suit was initiated, the NRC revisited its prior investigation and reached the same conclusions. 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. at 308. Finally, if the action was based on the public disclosure, was the relator an original source? 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. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. The court did not inquire into the fullness of the government's investigation. CIV.A. A separate order will be entered herewith. 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. 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. For convenience, references herein to the "Complaint" shall include the most recent version. 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. See United States v. Purdue Frederick Co., 495 F. Supp. Certain sealed material has been redacted from the publicly released copy of this opinion. 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. Purdue cites United States ex rel. With respect to the settlement attempts, it would seem counterintuitive to enforce a release to bar a subsequent qui tam suit, thus foreclosing the relator's ability to prosecute on behalf of the government, to punish that relator for trying to settle instead of filing suit in the first place. 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. (c).) 1991), which builds upon the Rumery test. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. 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." 1999). McLean v. County of Santa Clara, No. To determine whether the circumstances of a case fall within the general rule articulated in Green or the exception in Hall, the critical issue is the completeness of the government's knowledge or the fullness of its investigation. Purdue argues that Radcliffe has failed to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). 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. 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. However, Radcliffe did file while the government was still investigating and when he could potentially still have been of use to the government. Hall, 104 F.3d at 231. 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. But see United States ex rel. 3729-3733 (West 2003 & Supp.2008), and analogous state statutes, the relator Mark Radcliffe alleges that the defendants, Purdue Pharma, L.P. and Purdue Pharma, Inc. (collectively, "Purdue"), misrepresented to physicians the relative potency of . Radcliffe's allegations pertain to the issue of the relative cost and potency of OxyContin and MS Contin. 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. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. 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. 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. Id. at 1277-78. at 817. Ga. Oct. 27, 2005) (citing DeCarlo for the opposite conclusion). These disclosures suggest legitimate scientific debate and disagreement regarding the correct equianalgesic ratio, rather than any fraudulent intent on the part of Purdue. Several months later, as part of a general restructuring of its sales force, Purdue Pharma offered Radcliffe a severance package, which he accepted. 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. After the present qui tam suit was stayed, the government's investigation continued. 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. 434. Coleson, which was decided prior to Green but after Rumery, involved a claim brought under the anti-retaliation provisions of the FCA, rather than a qui tam claim brought on behalf of the government. 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. at 233. Specifically, he alleged that Purdue fraudulently marketed OxyContin using the 2:1 equianalgesic ratio, thus claiming that its relative cost was less than that of MS Contin. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. 2007). Green involved a general release between an employer and a terminated employee, who later filed a qui tam suit against that employer. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. He submits that each OxyContin prescription submitted to the government for reimbursement constitutes a false claim under the FCA and the analogous state statutes, because the product distributed had only half the potency that physicians and decision-makers had been led to believe it possessed. 1:07-CR-00029 (W.D. Mistick PBT v. Hous. Id. 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. Id. For these reasons, I find that this court his subject matter jurisdiction over the Complaint. 1996). at 969. It is unclear from the Complaint and subsequent filings whether Radcliffe ever read this study or merely heard about it from the supervisors and physicians. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. Purdue Pharma Br. 2d. Purdue's response was ambiguous, first stating that Radcliffe did not have legitimate claim, but if he thought he did he should make it, then expressing an interest in investing in Radcliffe's company. & Training Trust Fund. Thus, I find that these constitute public disclosures in the news media. 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. at 1513. to Mot. . 481 F. Supp. While this would seem to be the case in Hall since the federal government had not only completed its investigation, but concluded that the allegations could not be substantiated, this does not mean that there are not other cases that the government may have investigated fully but determined that it would not prosecute on its own for a variety of reasons, such as the low amount of money involved compared to the cost of prosecution, the low likelihood of success, or the lack of government resources to pursue it. . 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. I agree. Thus, the exception created by Hall provides that a release entered into after the government has full knowledge of the allegations and an opportunity to investigate will be enforced to bar a subsequent qui tam suit. 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. Id. However, the Ninth Circuit noted that: and rejected this argument because of the ex ante effects of enforcing the agreement. 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 Green, 59 F.3d at 965-68; Bahrani, 183 F. Supp. Prior public disclosures revealed the spin off, the company's problems with the unfunded pension liability, and eventually, the company's bankruptcy. Therapeutics 130 [Abstract PI-4] (1996); G.B. In his job marketing OxyContin to physicians, the relator Radcliffe became familiar with claims made by Purdue about the medication's relative cost and potency. Green, 59 F.3d at 962 (quoting Rumery, 480 U.S. at 392), 107 S.Ct. 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. 1995), and United States ex rel Hall v. Teledyne Wah Chang Albany, 104 F.3d 230 (9th Cir. 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. at 820. 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 . Casetext, Inc. and Casetext are not a law firm and do not provide legal advice. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. Redactions are denoted in brackets. On June 24, 2005, a conversation took place between Department of Justice attorney Barbara Wells and attorney Michael Scheininger, who represented several Purdue employees, about topics that would be discussed when those employees testified before the grand jury investigating Purdue. 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. 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. The FCA provides that there is no subject matter jurisdiction in a case where the claim is. 2d 766, 774 (W.D. 1982). 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. Purdue initially contended that the Complaint failed to state a claim because Radcliffe's allegations merely showed "a scientific dispute . Id. 2010). It was dismissed for failure to plead fraud with sufficient particularity. 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. 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. . 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. Defs.' Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. Bahrani, 183 F. Supp. Mot. 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. In doing so, the court relied on the test set forth in Town of Newton v. Rumery, 480 U.S. 386, 107 S.Ct. Specifically, they argue that, as here, where the government learned of the allegations independently and had already begun its investigation into the substance of the allegations prior to the date of the release, where the relator delayed in filing the qui tam complaint and attempted to settle with the defendants prior to doing so, and where the government ultimately chose not to intervene, enforcement of the release is appropriate. Va. 1989). He further stated that "the 2:1 comparison of OxyContin to MSContin [wa]s one of the areas under investigation." 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. (Information 20, United States v. Purdue Frederick Co., No. 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. 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. Purdue then filed the present Motion to Dismiss, seeking a dismissal on the grounds that Radcliffe's claims are based on publicly disclosed information rather than information he discovered; that Radcliffe has released Purdue from the claims; and that the Complaint fails to adequately allege fraud as required by Federal Rule of Civil Procedure 9(b). at 963. 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