Cosmetic Practitioners Take Huge Risks Purchasing and Administering Illegal Botulinum Toxin Drug Products

September 2017 | Volume 16 | Issue 9 | Editorials | 936 | Copyright © September 2017

Sheldon Bradshaw JD

FDA and Life Sciences Practice Group, King & Spalding,Washington, DC

Medica, if its location and principals can ever be located, is also probably on borrowed time: on November 10, 2016, Allergan (the manufacturer of Botox) filed suit against Amazon Medica, alleging that “Amazon Medica is a rogue and unlicensed foreign criminal entity that illegally advertises, imports, sells, and ships prescription medicines to unwitting doctors in the United States. These doctors, in turn, inject the unlawfully obtained, adulterated, and potentially unsafe prescription medicines into unknowing and unsuspecting patients. Amazon Medica misleads these doctors and endangers patient safety in the pursuit of unearned financial profit.” Allergan is seeking to locate Amazon Medica and identify its principals through litigation discovery. Case proceedings could ultimately reveal U.S. doctors who have purchased illegally from Amazon Medica.FDA Cracking Down on Doctors and Illegal DistributorsThe FDA, as part of its efforts to combat importation of unapproved drugs, has for several years gone after purveyors of unapproved botulinum toxin products. On August 7, 2013, the FDA’s OCI announced that eleven people had been charged in a case involving Gallant Pharma International Inc., an unlicensed company accused of distributing misbranded prescription drugs, including injectable cosmetic drug products. A physician who owned an esthetic and skin care clinic in Virginia (as well as his office manager) was convicted at trial for partnering with Gallant in exchange for a deeply discounted price on non-FDA approved cosmetic drugs and devices. The physician used these cosmetic drugs and devices at his practice without the patients’ knowledge or consent. He also provided Gallant with his medical license to enable Gallant to order non-FDA approved chemotherapy and cosmetic drugs from around the world, and allowed those drugs to be smuggled into the United States, addressed to his clinic. Many of the shipments involved “cold-chain” drugs subject to strict temperature controls (which were not followed by the conspirators), and the use of those drugs posed serious potential harm to patients throughout the U.S.More recently, DOJ announced on June 16, 2017 that (following an FDA investigation) the owner of Midwest Medical Aesthetics Center Inc., Kathleen Stegman, had been charged with obtaining Botox and Dysport from foreign sources. If convicted she faces up to three years in federal prison (under the older, more lenient, penalty provisions in the FD&C Act that, as noted above, have now been significantly enhanced). And, on June 19, 2017, six Canadian men associated with (and affiliated companies) were arrested under the Extradition Act. DOJ and FDA have accused the men of illegally importing $78 million worth of unapproved drug products into the U.S.FDA Letters to DoctorsFollowing a trend noted in Dr. Beer and Ms. Rothchild’s 2014 article, the FDA continues to issue thousands of letters – publicly identifying recipients – to doctors purchasing unapproved botulinum toxin products and other products from illegal distributors. On April 1, 2015, the FDA sent more than 300 letters to medical practices that purchased from Gallant Pharma. On March 21, 2016, the FDA issued more than 1,300 letters to medical practices that purchased unapproved prescription drugs and/or injectable devices from TC Medical (aka SB Medical – one of Bridget Goddard’s Botox sellers). And, on March 30, 2016, the FDA sent approximately 100 letters to medical practices that had purchased from TC Medical and had also purchased from a different unlicensed distributor previously (and had previously received one of the FDA letters). The FDA singled out one of the doctors for previously receiving FDA letters for purchasing from two other illegal distributorsReceiving one of these FDA letters is not a good thing for doctors. Doctors who receive the letters could become the target of a criminal investigation, especially doctors who receive FDA letters for purchasing from more than one illegal distributor (eg, doctors listed in an FDA document titled “repeat offenders”). Further, receiving such an FDA letter makes it markedly more difficult for the doctor to plead ignorance of the law with respect to future purchases of unapproved products. Being publicly identified by the FDA also puts the doctor’s professional reputation at risk – particularly if local newspapers report on the matter – and exposes practitioners to medical board disciplinary actions, including possible loss of their medical licenses (eg, for violating federal law by purchasing and administering misbranded or adulterated drugs).Malpractice LiabilityWhen doctors buy misbranded, non-FDA-approved or adulterated drugs from overseas distributors it is illegal, and threatens the health of their patients. These drugs:• May contain harmful ingredients;• May be ineffective, containing incorrect amounts of active ingredients or no active ingredient at all;• May cause adverse health events;• May be expired; or• May have been produced, stored and imported under insanitary or incorrect conditions.If the patient suffers an adverse event from one of these counterfeit or diverted drugs, the doctor should not expect his malpractice carrier to provide any assistance: malpractice policies typically exclude liability arising from criminal acts (eg, administering botulinum toxins not approved for use in the United States).