Gulf Med Pharmacy, Inc. v. Dhillon
| Decision Date | 23 June 2020 |
| Docket Number | Case No: 2:20-cv-420-FtM-29NPM |
| Citation | 469 F.Supp.3d 1316 |
| Parties | GULF MED PHARMACY, INC., Petitioner, v. Uttam DHILLON, in his official capacity as Acting Administrator and United States Drug Enforcement Administration, Respondents. |
| Court | U.S. District Court — Middle District of Florida |
Dale R. Sisco, Dominic Anthony Isgro, Sisco-Law, Tampa, FL, for Petitioner.
Kyle Scott Cohen, US Attorney's Office, Ft. Myers, FL, for Respondents.
This matter comes before the Court on plaintiff's Petition to Dissolve Immediate Suspension Order (Doc. #1) filed on April 14, 2020. The government filed a Response in Opposition (Doc. #6) on June 15, 2020. For the reasons set forth below, the Petition is denied.
Plaintiff Gulf Med Pharmacy, Inc. (Gulf Med or the pharmacy) seeks to dissolve the ex parte suspension of its DEA Certification of Registration No. FG6290061 (COR). Plaintiff's COR was suspended by the Drug Enforcement Agency (DEA) through an Immediate Suspension Order (ISO) based on the administrative finding that plaintiff's continued registration to dispense controlled substances constituted an "imminent danger to the public health or safety" within the meaning of 21 U.S.C. §§ 824(d) and 882. Plaintiff requests that the ISO be immediately dissolved while the ongoing DEA administrative proceeding to determine whether a permanent revocation of the COR is appropriate continues.
Gulf Med is a family-owned business in Cape Coral, Florida which mostly serves patients and customers within a 10-mile radius of its pharmacy. Gulf Med employs Ricard Fertil, R. Ph., a pharmacist licensed since 2003, and one part-time pharmacy technician. The immediate suspension of the pharmacy's registration has resulted in the loss of all insurance-based business, the cancellation of plaintiff's primary wholesale supplier contract, and the loss of its compounding business. As a result, plaintiff now accepts cash-paying customers.
On February 9, 2018, an Application for Administrative Inspection Warrant (Doc. #6-2) was filed in the Fort Myers Division of the United States District Court for the Middle District of Florida "because the pharmacy has dispensed a high percentage of the two of the most highly abused Schedule 2 controlled substances and has not previously been subject to inspection by the DEA." (Doc. #6-2, p. 4.) An Affidavit for Administrative Inspection Warrant (Doc. #6-2, p. 5) (the Affidavit) was submitted by Margorie C. Milan, a Diversion Investigator of the DEA, assigned to the DEA, Miami Field Division. The Affidavit asserts that a review of the Automated Reports and Consolidated Orders System (ARCOS) records for 2017 revealed that plaintiff dispensed a high percentage of highly abused controlled substances. In 2017, 1,385 prescriptions were dispensed at the pharmacy, of which 232 were for oxycodone and 117 were for hydrocodone. This represented 29% and 14% of all prescriptions, respectively. The Affidavit submits that the 43% of prescriptions for highly abused controlled substances establishes a valid public interest in establishing a full and complete accountability. The Affidavit was sworn to before a United States Magistrate Judge on February 12, 2018, and the Warrant for Inspection (Doc. #6-2, p. 13) was issued on the same day. The Return of Warrant (Doc. #6-3) indicates service of the warrant on Mr. Fertil on February 14, 2018. On the same day, a Subpoena (Doc. #6-4) was issued for the full profiles and prescription history for 28 specific patients.
Patient profiles are the documents in which a pharmacy would ordinarily record any "red flags" for a given prescription and how the pharmacy resolved the "red flags," as required under Florida law. None of the patient profiles contained any record of notes, comments, or indication of a resolution of a "red flags". Another Subpoena (Doc. #6-5) was issued on May 1, 2019, for the full profiles of 7 of the 28 and for an additional 7 patients. No evidence of an effort to address potential "red flag" prescriptions was found. On August 9, 2019, another Subpoena (Doc. #6-6) was issued for the updated profile of 1 patient, and for 5 additional patients. No evidence of an effort to address potential "red flag" prescriptions was found in the documents produced pursuant to this third request. In or around September 2019, plaintiff's COR was renewed. (Doc. #1, p. 19.)
On November 18, 2019, an Order to Show Cause and Immediate Suspension of Registration (Doc. #6-1) was issued by the DEA. The Order sets forth several areas of concern that were identified. As to cocktail medications (i.e., combinations of controlled substances widely known to be abused or diverted), examples with unresolved "red flags" included:
(Doc. #6-1, ¶ 7.) The DEA expert opined that the cocktail of an opioid, a benzodiazepine, and carisoprodol (the "Trinity cocktail") is a serious red flag because the combination is highly dangerous. Plaintiff was found to have repeatedly dispensed Trinity cocktails without any indication that the pharmacists addressed or resolved the risk. (Id., ¶ 8.)
Additionally, from at least March 22, 2017, until at least August 8, 2019, plaintiff repeatedly filled prescriptions for patients receiving a much greater daily morphine milligram equivalent dosage of short-acting opioids than long-acting opioids. In the DEA expert's view, because these prescriptions were illogical from a pharmacological perspective, they therefore raised a red flag, yet the pharmacist failed to address it. Examples of such improper prescriptions included:
(Id., ¶ 10.)
Gulf Med also regularly filled controlled substance prescriptions for individuals who traveled an unusual distance to obtain their prescriptions, which is another indication of diversion and/or abuse that should have raised a red flag. Examples included:
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