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Just months after the discovery that Florida doctors were treating patients with a dangerous, unapproved botulinum toxin to remove wrinkles, the Legislature has quietly passed a measure that would make it harder to discipline doctors for using unregulated pharmaceutical products. The bill, spearheaded by state Sen. Durell Peaden, R-Crestview, a retired physician, gives doctors facing disciplinary action by the state Department of Health a powerful new defense against any allegation of misusing drugs. Under the bill, doctors can argue to the state that they relied in good faith on the representations of the drug manufacturer or its representatives, and that the doctors had no intent to violate the law. While the language was crafted as a result of the widely publicized use of unregulated stabilized botulinum toxin, which was distributed by Tucson, Ariz.-based Toxin Research International, the measure is broadly written and could apply to doctors’ use of any pharmaceutical product. Under the bill, doctors would be allowed to use this new defense only in Health Department disciplinary cases, not in criminal or civil malpractice cases. If signed into law by Gov. Jeb Bush, the bill could thwart attempts by the Health Department to sanction a number of doctors it has accused of using unapproved knockoffs of Botox. Julie Gallagher, a partner at Greenberg Traurig in Tallahassee who is representing three of the doctors facing disciplinary action, said, “Our position is that these doctors relied in good faith on the representations made to them by [Toxin Research International]. That company lied to them and misled them just like Enron lied to the world. To suggest that doctors can’t rely on the representations of drug companies is ridiculous because they do it every day in their practice.” But the Academy of Florida Trial Lawyers criticized the legislative measure, warning that it puts patients at increased risk from drugs that are adulterated or not prepared in line with good medical standards. “[Doctors] shouldn’t be able to get a drug from a shady character, not know their credential, not know their reputation, and be able to rely on that if they end up injuring somebody,” said Debra Henley, a lobbyist for the academy. In February, Dr. Daniel Campbell Daube Jr., one of the doctors who initially had his medical license suspended due to his alleged use of the unregulated botulinum toxin, contributed $500 to Peaden shortly after his suspension. Daube’s wife, Kellie, gave Peaden another $500. Dr. Daube also gave $500 each to Rep. Rene Garcia, R-Hialeah, and Rep. Joe Negron, R-Stuart. Peaden denied that the campaign contributions affected his decision to offer the language, saying he doesn’t know who gives him campaign money. Garcia and Negron could not be reached for comment by deadline. The botulinum toxin issue arose in December when the Health Department, by emergency action, suspended the licenses of chiropractor Thomas Toia and osteopaths Alfred Boyce, Bach McComb and Shelly Wolland. McComb, who practiced in Oakland Park, already was under an emergency suspension order at the time of the December suspension. In December, four people linked with the Oakland Park, Fla., medical facility were hospitalized in serious condition with botulism toxin poisoning. Botulinum toxin is produced by C botulinum and causes muscle paralysis. In approved drugs such as Botox, tiny amounts of the toxin are injected under the skin to smooth facial wrinkles and treat certain muscle disorders. The suspensions came after McComb accidentally paralyzed himself with the injections of botulism toxin. That prompted an investigation by the U.S. Food and Drug Administration into the sale and use of unapproved stabilized botulinum toxin sales around the country by Toxin Research International. Later, the Health Department, also through emergency order, suspended the licenses of other physicians, including Daube, who’s from Panama City; Albert Cioffi of Pompano Beach and Boca Raton; Helen Donatelli of Sunny Isles Beach; Stephen Chiarello of Port Charlotte; and Norman Cohen of Jacksonville, Fla. In its recent emergency orders against the doctors, the Health Department charged them with violating the Florida Drug and Cosmetic Act, which prohibits a person from selling, manufacturing, repackaging or distributing any new drug unless an approved application has become effective under federal law That violation, the Health Department said in its emergency order, led to other violations of the laws and rules that regulate Florida doctors. These included purchasing and administering unapproved botulinum toxin A, failing to maintain proper records, and not obtaining permission to use an unapproved toxin. ‘GOOD FAITH’ S.B. 1180 started out as a measure to add more members of the public to the state Board of Medicine, the 15-member body appointed by the governor to oversee medical licensure. It currently has 12 physician members and three public members. The bill that passed did add two more public members. Sen. Peaden said he added the language that gives doctors the new defense against misuse of drugs because it’s a violation of physicians’ due process rights when the Health Department suspends their license under an emergency order.This emergency procedure, he said, does not allow physicians a full opportunity to contest the allegations, such as arguing that they relied in good faith on a drug manufacturer’s representations about a product. “You can’t come into somebody’s office and arrest them and suspend their license if they have good faith,” Peaden said. The Florida Medical Association was neutral on the disciplinary provision, said Francine Plendl, the group’s director of governmental affairs. But the Academy of Florida Trial Lawyers said the bill would frustrate the intent of Florida voters when they approved a constitutional amendment in November to revoke the licenses of doctors with three or more malpractice findings against them. PRACTICE ‘MAY NOT SURVIVE’ In a Jan. 14 emergency order, the Health Department said Dr. Daube allegedly purchased $18,400 of the unregulated botulinum toxin between December 2003 and November 2004. Between August 2003 and January 2005, the department said, Daube treated 14 patients for wrinkles. The Health Department’s emergency order alleges that Daube used the unapproved product on patients as if it were the regulated Botox product, and that patient records did not reflect which patient received which drug. Moreover, the order alleges, Daube did not get prior authorization to treat the patients with the unapproved drug. Earlier this year, Daube and other doctors who had their licenses suspended on an emergency basis appealed the actions to the 1st District Court of Appeal in Tallahassee, and all were granted emergency stays. In January, Daube was elected chief of staff at the Gulf Coast Medical Center in Panama City. He serves on the board of directors of the Bay County Medical Society and has on-call duties at two hospitals in Panama City. In a Jan, 18 affidavit, Daube said he was concerned that his private practice “may not survive” his license suspension and that he would be “forced to close the doors on my office clinic.” NO HARM, NO FOUL On Feb. 22, a three-member panel of the 1st DCA ruled in the Daube case, and that opinion subsequently was applied to the other cases on appeal. The 1st DCA held that the Health Department’s emergency order was broader than necessary to protect public safety because the department did not allege that any of Daube’s patients had been harmed or suffered adverse outcome or injury. In addition, the court said, the Health Department did not challenge Daube’s assertion that he had stopped using the unregulated botulism toxin product. Therefore, the court ruled that there was no showing of imminent harm or that the events were likely to re-occur. “By granting the stay, we are not questioning the seriousness of the allegation that petitioner used an unapproved product on patients without their consent,” the 1st DCA panel ruled. “Punishment for past behavior is properly the subject of an administrative complaint … wherein the licensee is afforded the opportunity to challenge the factual basis of the complaint.” After the 1st DCA ruling, the Health Department issued emergency license restriction orders for Daube and the other doctors, which allowed them to continue practicing while their disciplinary cases proceeded, according to Lindsay Hodges, a Health Department spokeswoman. But the emergency suspensions of McComb, Toia, Boyce and Wolland were not affected by the 1st DCA ruling. They remain in effect, Hodges said. Vidian Mallard, a partner at the Miami plaintiff firm Ford, Dean, Sharp & Mallard, said that if the Legislature thought the Health Department was violating doctors’ rights with its emergency suspension procedures, it could have fixed that problem without extending such broad new protection to doctors. “You don’t solve the problem by saying [doctors] can rely on whatever the pharmaceutical company is going to tell them,” Mallard said. “The pharmaceutical companies are going to tell them whatever they want to hear to get them to get the drug out. In that case, why don’t you have the pharmaceutical salesman hand it directly to the patient?”

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