Division of Administrative Hearings, Florida
Latest Update: Jun. 07, 1989
This proceeding involves two administrative complaints filed against Dr. Willner. In Case 86-2054, the complaint sought disciplinary action for Violating Section 458.331(1)(u) Florida Statutes, (1981) by performing a procedure or prescribing a therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed and written consent by treating patients for obesity with a product known as "NatureSlim" which had not been proven safe and effective for human use (Count 1); Violating Section 458.331(1)(d) Florida Statutes, (1983) by being guilty of false, deceptive or misleading advertisement with respect to claims made for a diet program known as "Forever Thin" (Count 2); Violating Section 458.331(1)(h) Florida Statutes, (1983) by failing to perform a statutory or legal obligation placed upon a licensed physician by distributing a new drug that did not have a Federal or Florida investigational drug permit on file, in violation of 21 U.S.C. Section 355 and Section 429.023 Florida Statutes (1983) (Count 3); Violating Section 458.331(1)(t) Florida Statutes, (1983) by gross or repeated malpractice or the failure to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by failing to obtain full, informed written consent from patients who were sold glucomannan, which the department contends was an unapproved new drug (Count 4); and Violating Section 458.331(1)(u) Florida Statutes, (1983) by performing any procedure or prescribing any therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed and written consent from those who used the drugs included in the "Forever Thin" diet program (Count 5). The administrative complaint in Case 87-1599 sought to discipline Dr. Willner for Violating Section 458.331(1)(d) Florida Statutes, (1985) by false, deceptive or misleading advertisement with respect to claims made for products marketed under the name of the "Ultimate Solution Diet Program" (Count 1, paragraph 22); Violating Section 458.331(1)(1) Florida Statutes, (1985) by making deceptive, untrue, or fraudulent representations in the practice of medicine, or employing a trick or scheme in the practice of medicine when that scheme or trick fails to conform to the generally prevailing standards of treatment in the medical community in connection with the promotion of the "Ultimate Solution Diet Program"; [Count 2, paragraph 24] Violating Section 458.331(1)(n) Florida Statutes, (1985) by failing to keep written medical records justifying the course of treatment of patients, including, but not limited to, patient histories, examination results, and test results for persons who were told they were part of a select group of persons offered the new drugs contained in the "Ultimate Solution Diet Program"; [Count 3, paragraph 26] Violating Section 458.331(1)(u), Florida Statutes, (1985) by performing any procedure or prescribing any therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed, and written consent from persons offered the new drugs contained in the "Ultimate Solution Diet Program [Count 4, paragraph 28] Violating Section 458.331(1)(h) Florida Statutes, (1985) by failing to perform any statutory or legal obligation placed upon a licensed physician by failing to comply with Federal and Florida law governing the use of new or investigational drugs; [Count 5, paragraph 30] and Violating Section 458.331(1)(t) Florida Statutes, (1985) by gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances by his course of conduct in the marketing of the "Ultimate Solution Diet Program." [Count 6, paragraph 32]Doctor who tested substances as diet drugs on humans without investigational drug permit guilty of numerous violations of state and federal statutes