Volkman v. U.S. Drug Enforcement Admin.

Citation567 F.3d 215
Decision Date03 June 2009
Docket NumberNo. 08-3802.,08-3802.
CourtUnited States Courts of Appeals. United States Court of Appeals (6th Circuit)
567 F.3d 215
Paul H. VOLKMAN, Petitioner,
No. 08-3802.
United States Court of Appeals, Sixth Circuit.
Argued: March 12, 2009.
Decided and Filed: June 3, 2009.

[567 F.3d 216]

ARGUED: Kevin P. Byers, Kevin P. Byers Co., LPA, Columbus, Ohio, for Petitioner. Tritia Lindsay Yuen, United

[567 F.3d 217]

States Department of Justice, Washington, D.C., for Respondent. ON BRIEF: Kevin P. Byers, Kevin P. Byers, Co., LPA, Columbus, Ohio, for Petitioner. Anita J. Gay, United States Department of Justice, Washington, D.C., for Respondent.

Before: MARTIN and GILMAN, Circuit Judges; ZOUHARY, District Judge.*


BOYCE F. MARTIN, JR., Circuit Judge.

Paul Volkman applied for a federal registration to dispense controlled substances. The Drug Enforcement Agency denied his application, concluding that Volkman's registration was not in the public interest. The DEA reached this conclusion based on its finding that Volkman's prior prescribing practices violated state and federal law. Paul H. Volkman, Denial of Application, 73 FR 30629-03, No. 06-46 (May 28, 2008). Volkman petitions this Court for review of the DEA's denial of his application. Because the DEA's determination is in accordance with law and is supported by substantial evidence, we DENY Volkman's petition.


Volkman holds an M.D. and a Ph.D. from the University of Chicago. In 2003, after large medical malpractice settlements and judgments left him unable to purchase malpractice insurance, Volkman started working at Tri-State Healthcare, a pain clinic in Portsmouth, Ohio. Denise Huffman, who is not a physician or a healthcare professional, owned Tri-State and paid Volkman $5,000 a week to start. (Volkman says that he was never a Tri-State employee, and was, instead, an independent contractor.) As required by the Controlled Substances Act, Volkman applied for a DEA registration to prescribe controlled substances from Tri-State's office. The DEA granted his application.

Soon after he began working at Tri-State, pharmacists in the area started complaining to the Ohio State Board of Pharmacy about Volkman's prescribing practices. One pharmacist said that Volkman was "writing large quantities of narcotics and benzodiazepines" and that many of his patients were "prior problem patients" of a physician who had been convicted of drug trafficking. That pharmacist refused to fill any of Volkman's prescriptions. A second pharmacist complained that Volkman was prescribing "duplicate therapy of narcotics." Yet another told the Board that he was having "trouble" with Volkman's patients, and that they "smelled of beer and dope." These calls continued throughout the summer of 2003. Around the same time, Volkman applied to the Board for a "Terminal Distributor of Dangerous Drugs license"—a state license that allows a clinic to buy controlled substances and dispense them directly from the clinic. The Board inspected Tri-State's clinic and, despite the complaints, granted Volkman's application for the on-site distribution license.

Once Volkman had both a DEA registration and a state license, Tri-State, using Volkman's DEA registration number, started ordering dosage units of oxycodone and a combination of hydrocodone and acetaminophen. The volume of Tri-State's drug purchases was, compared to other practitioners, very large: During the last six months of 2003, Tri-State purchased

567 F.3d 218

more than twenty-eight times the amount of oxycodone purchased by the next largest Ohio-based practitioner. And in 2004, Tri-State was the largest practitioner-purchaser of oxycodone in the United States.

The DEA office in Columbus, Ohio also received complaints about Volkman. One pharmacist in Kenova, Ohio reported that Volkman was prescribing "numerous prescriptions for OxyContin and Percocet" in "very large" quantities. He reported that the customers with prescriptions from Volkman "were lining up outside" of his pharmacy to get them filled. The Columbus DEA office got a call from a fellow agent in Texas passing along a report from a drug distributor there that Volkman had ordered large quantities of combination hydrocodone and acetaminophen. In November 2003, an area physician called the DEA to report that "numerous" Volkman patients were seeking detoxification treatment because Volkman was prescribing excessive amounts of opiates such as OxyContin, Percocet, and hydrocodone. In response to these complaints, the DEA obtained pharmacy records and a list of all the scheduled drugs dispensed under Volkman's prescriptions.

Later in 2003, Tri-State moved its clinic to a new location. The move triggered another inspection by the Ohio Board of Pharmacy. This time, the state agent inspecting Tri-State found several violations, including incomplete records and dispensing logs. He also noted some remarkable differences between Tri-State and "your normal doctor's office," including a Glock handgun, two night sticks and a four-foot club with leather straps—all in the area where the clinic dispensed drugs. The agent also observed that the clinic's owner appeared "over medicated" and received reports that sometimes twenty to thirty cars were lined up outside the clinic. All this led the state agent to suspect that Volkman was running a "prescription mill." But this suspicion did not induce the Board to withhold the clinic's state license; instead, it issued the license on February 4, 2004, after Volkman sent a letter stating that Tri-State was "in compliance with all issues."

There was little activity on the part of the DEA or the Ohio State Board of Pharmacy for the following year and half until June 7, 2005 when the DEA executed a search warrant at Tri-State and seized controlled substances, patient records, invoices, DEA forms, and financial records. One DEA investigator interviewed Denise Huffman, who reported that the clinic was a "full cash business," charging $200 for an office visit. Huffman said that her daughter, Alice Huffman, and Volkman "were in complete control of the dispensing center." Alice Huffman confirmed this and provided the agent with the names of two Tri-State patients who had died from drug overdoses. She also admitted that she was supposed to "keep the records," including dispensing logs, but did not and was not sure if inventories existed at all, nor whether any records that might exist would be accurate. The DEA agents tried to take an inventory of the drugs they seized by checking Tri-State's dispensing logs against records from the drug distributors. But the agents did not find any initial or biennial inventories of the drugs, nor any dispensing logs for the year 2004. According to the DEA, the clinic could not account for over one million products or tablets of the audited controlled substances. Denise Huffman later produced logs for 2005, but admitted that there were no records for 2004.

Volkman continued working at Tri-State for a few months after the raid, but then quit and started seeing patients out of his apartment. In October 2005, the Portsmouth Police Department executed a

567 F.3d 219

search warrant there and seized Volkman's patient files. The Department never filed any charges but issued a condemnation notice for the apartment.

Volkman then moved about an hour north to Chillicothe, Ohio and applied to modify his DEA registration to reflect this new location. Some four months later, DEA investigators obtained a search warrant for the Chillicothe clinic, which they executed on February 10, 2006 by, according to Volkman's brief, sweeping in "with helicopters, guns, and masked agents" in a "shock and awe raid." Three days later, the DEA served Volkman an Order to Show Cause, informing him that his DEA registration to distribute controlled substances would be suspended immediately under 21 U.S.C. § 824(d) because his continued registration constituted "an imminent danger to the public health and safety." The next day, Volkman filed a written request for an expedited hearing and asked for full access to his records. He later applied for a renewal of his DEA registration.

Volkman's DEA hearing started on December 5, 2006 and continued until December 8. On December 8, the hearing was adjourned and resumed on January 9, 2007. Among other witnesses, two physicians, L. Douglas Kennedy and Wayne Wheeler, testified as experts on behalf of the DEA. Volkman testified in his defense, as did a former Tri-State employee and two employees who worked for Volkman after he left Tri-State. Both sides also submitted written evidence to the administrative law judge.

The administrative law judge issued her recommendation in June 2007. She found that Volkman unlawfully prescribed controlled substances, failed to adequately monitor patients, which directly contributed to the deaths of at least sixteen patients, improperly dispensed controlled substances, did not maintain adequate records or inventories, and repeatedly refused to take responsibility for his behavior. She recommended revocation of his DEA registration and denial of any pending applications.

The DEA Deputy Administrator reviewed the evidence and the administrative law judge's recommendations and concluded that granting Volkman's application for a new registration1 would be "inconsistent with the public interest," in contravention of 21 U.S.C. § 823(f), based on Volkman's "experience in dispensing controlled substances," his lack of compliance with state and federal law relating to controlled substances, and "other conduct which may threaten the public health and safety." The Deputy Administrator also considered and rejected Volkman's claims that he was denied due process and that the decision was in conflict with the Supreme Court's decision in Gonzales v. Oregon, 546 U.S. 243, 126 S.Ct. 904, 163 L.Ed.2d 748 (2006). Volkman petitions this Court for review.


The Deputy Administrator's factual findings are conclusive if they are...

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