阿片類藥物危機中的一項新攻擊:針對兩名田納西州藥房及其藥劑師的臨時臨時限製令和投訴,指控非法的阿片類藥物分配和虛假索賠法案違反行為,

2019年2月25日 經過卡拉·帕爾默(Karla L. Palmer)-

美國司法部(“ DOJ”)於2019年2月8日宣布,在其執法武器庫中使用新武器來幫助管理阿片類藥物危機。It involved a coordinated effort including DOJ’s Prescription Interdiction & Litigation (“PIL”) Task Force, which deploys all available criminal, civil, and regulatory tools “to reverse the tide of opioid overdoses in the United States,” stated the press release announcing the civil action,這裏

政府向田納西州中區的美國地方法院提起了公告申訴,該申訴針對兩名附屬的Celina,田納西州,藥房 - Oakley Pharmacy,Inc。,D/B/A Dale Hollow Pharmacy和Xpress Pharmacy;藥房的老板托馬斯·威爾(Thomas Weir);和藥劑師約翰·波爾斯頓(John Polston),邁克爾·格裏菲斯(Michael Griffith)和拉裏·拉金(Larry Larkin)。這抱怨聲稱被告正在違反《管製物質法》和《虛假索賠法》,處方並為醫療保險計費。投訴還聲稱,被告人對阿片類藥物的分配與至少兩個人的死亡以及其他人的急診治療有關藥物過量的治療。

政府在這裏的行動到底是什麼不尋常的?

第一的,政府對藥房進行了反對可以發言,他們的所有者/雇員是秘密的,通過對民事訴訟提起封印,然後尋求單方麵的臨時限製令和初步禁令,這是一種非凡的補救措施法院訴訟。法院在審理了政府動議並針對被告的情況下宣布投訴。這政府支持TRO的備忘錄指出有必要進行密封申請,並根據21 U.S.C.§843(f)鑒於被告在投訴和TRO備忘錄中描述的三年的DEA監管曆史,需要立即停止非法活動,以及所謂的真正威脅被告將繼續違反《管製物質法》並傷害公眾。據稱,被告違反了他們的相應責任,以確保根據合法的醫療目的發布處方21 C.F.R.§1306.04,但是,替代性也違反了21 U.S.C.§841(a)(1)根據政府藥房專家的聲明,通過故意和故意分配和分配受控物質以外的藥房實踐課程以外,通過填充未簽名的處方和多個處方,並帶有多個“危險信號”。

這government also stated that the ex parte proceeding was necessary because it intended to execute search warrants to obtain dispensing records, files and other evidence of illegal conduct from the pharmacies’ premises, and was concerned that, with notice, Defendants could take steps to alter or destroy records.

第二, the government chose to first file in federal court a Complaint and a Motion for a TRO, instead of pursuing DEA’s typical (and expected) administrative remedy in a corresponding responsibility case, which is seeking a DEA administrative Immediate Suspension Order (“ISO”) under21 U.S.C.§824(d)21 C.F.R.§1301.36。ISO具有與TRO相同的影響,使得藥房注冊人立即被“暫停”處理受控物質,而無需通知注冊人,在使用ISO時。此外,ISO不需要提交或法院幹預 - 在考慮事實和情況之後,DEA代理管理員在確定存在對公共健康或安全的迫在眉睫的威脅後,可能會發出ISO。

但是,在這種情況下,政府在其備忘錄的第19頁上指出,DEA正在“單獨考慮” ISO(但我們不知道為什麼在這一點上需要這樣做)。但是,政府表示,ISO將無法“限製”投訴中指定的單個被告的行為,因為這些人不是DEA注冊人。政府還指出,ISO缺乏基礎訴訟中尋求的禁令救濟的“最終定性”。但是,我們還指出,TRO和初步禁令確實是臨時補救措施。如果被告選擇這樣做,法院將完全審理禁令事項喂養。R. Civ。第65頁

第三, the government’s Complaint ties – in great detail – the pharmacies’ allegedly illegitimate prescriptions to violations of the False Claims Act, implicating the False Claims Act when prescriptions are filled for “illegitimate medical purposes“ or are not “reasonable and necessary” for the treatment of illness or injury. Although DEA has used in a similar approach in one other enforcement matter (against long term care pharmacy PharMerica), the government to our knowledge has not alleged violations of the False Claims Act in pharmacy corresponding responsibility matters. If successful, the government will be entitled to civil monetary penalties and treble damages for falsely billing Medicare for illegally dispensed prescriptions.

政府的新聞稿總結了以下警告藥劑師:

這action supported today by the Drug Enforcement Administration should serve as a warning to those in the pharmacy industry who choose to put profit over customer safety,” said D. Christopher Evans, Special Agent in Charge of DEA’s Louisville Field Division, which covers Tennessee, Kentucky, and West Virginia. “Pharmacists serve on the front lines of America’s opioid epidemic and they share responsibility with physicians to protect those whom they serve from the dangers associated with prescription medications. We will be vigilant in holding them accountable.