mark radcliffe purdue pharma

2006). 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. United States ex rel. Bahrani, 183 F. Supp. During this period . 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. Bahrani, 183 F. Supp. The generalized interest in settling litigation is outweighed in the present circumstances by public interests that would be impaired by enforcement of this release, and so analysis under the Rumery test does not favor enforcing Radcliffe's release. 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." formerly a sales representative for Purdue under Mark Radcliffe's supervision. Enforcing a release in this situation would deprive the public of a potential relator to enforce the FCA and recover monies for the government treasury. Regardless, the 1996 abstract was published in Clinical Pharmacology Therapeutics, a scientific journal headquartered in Alexandria, Virginia. 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 noted, Angela Radcliffe is Mark Radcliffe's wife; Steven May was formerly a sales representative for Purdue under Mark Radcliffe's supervision. Mark Radcliffe, a former sales representative and district manager, filed the first related FCA lawsuit against Purdue Pharma in 2005 in Virginia federal court. C D.) In addition to its inclusion in OxyContin packages, the package insert is available on Purdue's publically-assessable web site. United States District Court, W.D. Id. On August 2, 2005, a subpoena was issued commanding Radcliffe to appear before the grand jury. Id. Bahrani v. Conagra, Inc., 183 F. Supp. (Mem. Dismiss 11.) Contract Educ. The case previously reached the U.S. Court of Appeals for the Fourth Circuit, which refused to dismiss the case based on a lack of specific allegations because the whistleblowers still had the opportunity to amend their complaint. Hurts co-counsel in the case is Beckley, W.Va., attorney Paul Roop. 763 (E.D. First, was there a public disclosure? 2d 815, 818 (S.D. 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.. The FCA provides that there is no subject matter jurisdiction in a case where the claim is. They allege Purdue Pharma misrepresented the potency of OxyContin when marketing it to doctors. 1039, 1043-47 (S.D.N.Y. 14-2299 (4th Cir. 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 . Relators claims had no objectively reasonable chance of success, the company argues. 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. 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. 2010), the district court dismissed . (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. Id. 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. ), aff'd, 53 F. App'x 153 (2d Cir. It further states that OxyContin is "indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time." Va. 2008). On August 1, 2005, Radcliffe executed a general release as part of . For these reasons, I find that this court his subject matter jurisdiction over the Complaint. Training materials included this claim and Purdue encouraged sales representatives to emphasize this cost difference when speaking with physicians. 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. Curtis et al., Relative Potency of Controlled-Release Oxycodone and Controlled-Release Morphine in Postoperative Pain Model, 55 Eur. 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. 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". at 1043-46. A separate order will be entered herewith. DeCarlo v. Kiewit/AFC Enters., Inc., 937 F. Supp. 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. The court found no statutory or policy reasons to prevent enforcement of the release. Id. 49.7 (Patrick D. Wall Ronald Mezack eds. ex rel. Their lack of knowledge of the minutiae does not somehow render the complaint frivolous or filed in bad faith. 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. 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. ( Id. 1187. 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." Finally, if the action was based on the public disclosure, was the relator an original source? 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 . 2d 569, 576 (W.D. Matsushita Elec. 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. Id. 1991), which builds upon the Rumery test. 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. (Mountcastle Decl. 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. 1994) ("Textbook of Pain"). 1994); United States ex rel. The parties have been provided with the sealed copy. For convenience, references herein to the "Complaint" shall include the most recent version. 458 (S.D.N.Y. One of their attorneys is Mark 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. Radcliffe v. Purdue Pharma L.P., 582 F. Supp. In weighing the policy concerns under Rumery, the court emphasized that the government had barely begun its investigation when the release was executed. Id. (quoting 5 Charles Alan Wright Arthur R. Miller, Federal Practice and Procedure 1297, at 590 (2d ed. The Newsletter Bringing the Legal System to Light. 2:04 CV 053, 2006 WL 3834407, at *3 (S.D. Purdue Pharma L.P., et al., Civil Action Nos. 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. Radcliff is a former sales representative and manager at Purdue, who left its employment shortly before he filed the present suit. Further, Radcliffe was cooperating with the government and was scheduled to be a grand jury witness. These responses did not address the cost implications that concerned Radcliffe. 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. Mot. 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. It was dismissed for failure. He subsequently executed a general release ("the Release") of all claims against Purdue in order to receive an enhanced severance package. The Agreement and General Release that Radcliffe signed contained the following language: Radcliffe then filed his qui tam Complaint on September 27, 2005. Notwithstanding the government's lack of knowledge of or consent to the release, because the federal government was already aware of the allegations of fraud, the public interest in having information disclosed to the government was not implicated. 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 . 40 F.3d at 1510. On Nov. 17, the company moved to have the plaintiffs pay its legal fees under the fee-shifting provisions in the FCA. 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 also argues that in Hall itself the government had not completed its investigation prior to the execution of the release. 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. 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. 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. 9 n.4. 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. United States ex rel. 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. Mark T. Hurt, Abingdon, VA, and Paul W. Roop, II, Beckley, WV, for Mark Radcliffe. 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. Kennedy v. Aventis Pharms., Inc., 512 F. Supp. Servs., 260 F.3d 909, 916 (8th Cir. 2008). . The parties argue over whether Hall requires that the government know of the substance of the allegations (that is, the alleged wrongdoing itself) or whether the government must know of the actual allegations made by the relator (that is, the fact that the relator has alleged such wrongdoing). 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." 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. 2d at 1278. 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. Id. 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 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. Dismiss, Exs. On September 27, 2005, Radcliffe filed his qui tam Complaint. Id. 2d 1272, 1275-78 (D. Colo. 2002); United States ex rel. to Mot. at 1277-78. Ten years ago, Mark Radcliffe, a former district sales manager for Purdue Pharma, filed a qui tam action under the FCA against Purdue. Radcliffe v. Purdue Pharma L.P., 600 F.3d 319 (4th Cir. Id. United States ex rel. 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. It is undisputed that Radcliffe did not identify the nature of his allegations against Purdue in the course of these conversations with Ramseyer. 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 . Therapeutics 130 [Abstract PI-4] (1996); G.B. If the patient did not receive the expected pain relief, the doctor might either prescribe something else or increase the dosage. Make your practice more effective and efficient with Casetexts legal research suite. Virginia, Abingdon Division, declining to conclude that anything posted online would automaticallyconstitute a public disclosure. 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. 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."). 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. at 231-32. For the reasons stated, the Motion to Dismiss will be denied in part and granted in part, with leave to amend. Grayson v. Pac. 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. It was dismissed for failure to plead fraud with sufficient particularity. 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