Great Earth Compounding Pharmacy, along with a pharmacist, integrative medicine center, and two doctors, all based in southern California, are being sued by a family for unspecified damages related to a compounded testosterone cream prescribed for plaintiff Andrew Simpson. The suit alleges that Simpson’s wife and two children have all suffered serious medical consequences due to their exposure to the compounded cream. The complaint alleges that the defendants failed to warn Simpson of the risks associated with the product should women or children come into physical contact with the cream.

The Simpson’s suit was filed last week in Los Angeles Superior Court and alleges negligence, breach of warranty, fraud, and misrepresentation. Simpson states in the complaint that he began using the testosterone cream product prescribed to him by Akasha Center for Integrative Medicine doctors in April 2014 and that Simpson’s medical records showed that he was married with two children. Simpson claims that he was never informed by any of the defendants of the risks associated with the product and did not know until April 2016 that his use of the cream was causing “severe adverse medical problems to his family.” His wife developed “gynecological conditions” and underwent a premature hysterectomy, while the couple’s son, age 10, and daughter, age 5, “developed enlarged reproductive organs, growth of pubic hair, advanced bone age, precocious puberty, virilization, abnormally increased growth and aggressive behavior,” according to the complaint.

Compounded preparations are not regulated by the FDA, which means that the FDA does not verify the safety or effectiveness of compounded drugs.  The FDA looks to state boards of pharmacy for regulation and enforcement regarding compounding issues.  Further, because compounded drugs are not approved or regulated by the FDA, they have no official FDA labeling, thus leaving consumers “in the dark” about drug contraindications and warnings absent communication from pharmacists and other medical professionals about those risks.

Across the country, a growing number of lawsuits have been filed against compounding pharmacies for a multitude of ill effects visited upon consumers of compounded drugs, ranging from serious injury to, in the case of some contaminated drugs, death. The Simpson’s allegations make it a case to watch as it works its way through the California courts and presents another instance of why regulators at both the state and federal levels continue to look closely at increased oversight and regulation of compounded drugs and the pharmacies that produce them.