Attorneys for Wayne Wilkerson, who is alleged by the federal government to be the ring leader of a "cream scheme," said he should be found not guilty of all charges.
A 40-page legal brief from attorney Mark Thomas of Gainesville, Fla., says there was no proof shown during the lengthy trial that Wilkerson violated any law.
Prosecutors said Wilkerson made over $14 million and Michael Chatfield $5.4 million from encouraging others to order creams that were billed to insurance companies at prices up to $15,000 a jar.
Federal Judge Sandy Mattice heard the case against Wilkerson, Chatfield, Kasey Nicholson, Billy Hindmon and Jayson Montgomery and is expected to rule next month on their guilt or innocence. The judge would set the sentence if there are any guilty findings.
The legal brief says, "Whether the compounded medications at issue were prescribed pursuant to pre-existing conditions or medical necessity is the sole responsibility and authority of the prescribers and not Wilkerson.
"Whether the medications were clinically effective or had side effects is the responsibility of the prescribers and the dispensing pharmacies, and not Wilkerson.
"Whether the patients consented to receive the medications is the responsibility of the prescribers and dispensing pharmacies, and not Wilkerson.
"Whether any patients were paid to accept medications and/or participate in a patient study is not a violation of any law.
"Whether the patients received accurate and complete information as to copayments is solely the responsibility of the dispensing pharmacies and not Wilkerson.
"Whether Wilkerson reimbursed any patients for their copayments, such alleged acts do not violate any law because the legal duty to collect copayments is solely that of the pharmacies, and there is no legal requirement that the patient pay the copayment.
"Whether Wilkerson withheld information from patients, such as the reimbursement expense to be borne by the patients’ insurance plans, such alleged failures to inform do not violate any law, as even the pharmacies do not have a legal duty to disclose drug pricing to patients.
"Whether Wilkerson was both a patient and a sales representative who received sales commissions on his own medications, such alleged acts do not violate any provision of law.
"Whether Wilkerson employed some of the prescribing physicians, such alleged acts do not violate any law.
"Whether Wilkerson targeted specific insurance plans based upon those plans’ formularies and rates of reimbursement, such alleged acts do not violate any provision of law.
"Whether Wilkerson indeed acted or failed to act as alleged by the government, there is no pharmaceutical or insurance statute, regulation, guideline, manual, or contract that identifies such acts or omissions as discrepant under civil law (let alone illegal under any criminal law).
"Whether the government has now determined, ex post facto, that Wilkerson's alleged acts or omissions constitute crimes, Wilkerson was not placed on reasonable notice of such criminality at the time (because such acts or omissions were not and are not violative of any published civil law).
"The government failed to show that any act or failure to act of Wilkerson in any manner, ever, compromised the 'gatekeeping' functions of the licensed providers at issue – the prescribers and the dispensing pharmacies: a) the government failed to show even a single prescription was fraudulent or false due to any act or failure to act of Wilkerson; b) the government failed to show even one instance where Wilkerson’s act or failure to act affected any pharmacy’s filling and dispensing of a medication; c) the government failed to show even one instance where Wilkerson made a misrepresentation or material omission to a Pharmacy Benefit Manager or insurance plan; d) the government failed to show even a single act or failure to act of Wilkerson that caused a prescriber to write a prescription for a medication the prescriber would not otherwise have written.
"While Nurse Practitioner Candace Michele Craven testified that she wrote prescriptions for patients at Karma Medical Spa, she acknowledged that only she was responsible for determinations of adequate medical necessity, not Wilkerson.
"While Nurse Practitioner Craven accepted a plea agreement regarding her prescribing at Choice MD, such plea had nothing to do with Karma Medical Spa, Top Tier Medical, or Wayne Wilkerson.
"Even if the alleged acts or omissions of Wilkerson related to Karma Medical Spa and Top Tier Medical were in any manner non-compliant, these events were random, inconsistent and isolated aberrations, which essentially disproves an affirmative scheme to defraud by Wilkerson: a) there were approximately 500 patients and 3,500 prescriptions involved in the case, and the government was able to show a de minimus error rate of approximately 1% of that total; b) the government’s evidence as to payments or other incentives to patients were entirely limited to sales sub-representatives such as Matthew Perkins, and limited to approximately 20 out of 500 patients; c) there was no testimony that Wilkerson knew of or authorized anyone to pay any patients for anything or to offer any patient benefits; d) Wilkerson was paid sales commissions on 2 of his own prescriptions, out of a total of 3,500 prescriptions; e) many of the prescriptions were written by Nurse Practitioner Craven, but 73 other physicians or nurse practitioners also wrote prescriptions for which Top Tier Medical earned sales commissions; f) Wilkerson paid Nurse Practitioner Craven a W2 salary based upon the number of hours she worked at Karma Medical Spa, but such salary (roughly $100,000 per year) is a fraction of 1% of the total loss amount alleged by the government (i.e., it strains credulity that Craven wrote prescriptions that lacked adequate medical necessity in exchange for her Karma Medical Spa salary); g) Wilkerson certainly paid Jared Schwab, the Pharmacist in Charge at Willow Pharmacy, for Schwab’s consulting services for a few months, yet all but the initial payment to Schwab occurred after Wilkerson stopped doing business with Willow Pharmacy; h) the government did not show any payments to any pharmacists at Florida Pharmacy Solutions, Central Rexall Pharmacy, Soothe Pharmacy, or Riddle Pharmacy (there is no logic to the government’s premise that payments of several thousand dollars to Schwab at Willow Pharmacy would incentivize Willow and 4 other unrelated pharmacies to fill and dispense medically unnecessary prescriptions); i) Neither Schwab nor any other pharmacist testified in the case, so the government leaves the Court to speculate as to the pharmacies’ knowledge and intent (and speculation is not authorized under federal law); j) the only insurance plan audit involved, that of Blue Cross of Tennessee, was closed with no findings of irregularities; k) no prescriber, pharmacist, or pharmacy has been charged with a crime in this case; l) Saige Medical, LLC, with a similar business model as Top Tier Medical, was investigated in Indiana without a finding of any illegality."