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Class Actions in Homeopathic Products Segment
May 14, 2012
4 Min Read
The U.S. District Court, Southern District of California, has given preliminary approval for a settlement agreement in the class action lawsuit against Boiron Inc. The agreement could provide $5 million in refunds to consumers who purchased certain Boiron homeopathic products, including Oscillo, Arnicare, Chestal and Coldcalm. Boiron also agreed to change its labeling and add a disclaimer, as well as provide additional information on homeopathic dilution to its customers.
The suit, Gallucci v. Boiron, Inc., alleged Boiron made false claims its homeopathic products could effectively treat ailments such as the flu, arthritis, sore joints, join pain, aches, fever, coughs, insomnia or sleeplessness. However, the suit also attacks homeopathy in general, arguing the active ingredients in Boirons products are so diluted that they are effectively non-existent" and are akin to placebo or sugar pills.
One legal review of the settlement called homeopathy "snake oil," yet criticized the settlement for essentially lining the pockets of the class attorneys.
Two other class actions in California were filed against Hyland's and Standard Homeopathy, alleging the companies marketed their homeopathic products as having health benefits while knowing the products had no active ingredients in amount sufficient enough to cause any beneficial actions. The suits also accuse the defendants of violating the Consumer Legal Remedies Act, the Unfair Competition Law and the Unfair Advertising Law, as well as breach of express warranty, implied warranty of merchantability, and money had and received, money paid and unjust enrichment. The companies successfully won dismissal of the unjust enrichment charge, but the others stand.
The American Association of Homeopathic Pharmacists (AAHP) told me cases like these do not damage the reputation and viability of the homeopathic industry, and settling such lawsuits does not give allegations such as "no active ingredients to deliver benefits" any weight or credence:
"Although the organization does not speak on behalf of individual companies, AAHP officials assert they are unequivocal regarding the efficacy of homeopathic medicines. Homeopathic medicines have been in wide use for more than 200 years. The clinical effectiveness of homeopathic medicines has been demonstrated over that time via physicians experience and traditional clinical trials. Prescribed by hundreds of thousands of physicians throughout the world, homeopathy is one of the most widely practiced medical therapies worldwide and is used in over 80 countries by millions of people. Another major advantage to this system of medicine is its safety, which consumers and physicians will continue to seek out."
A few months ago, FDA sent a warning letter to Schwabe North America over claims and formulations in the company's line of homeopathy products. The agency said the products were marketed illegally because they combine approved homeopathy ingredients listed in the Homeopathic Pharmacopeia of the United States (HPUS) with non-approved, non-HPUS-listed ingredients; in addition, the company was warned of drug claims made for the products, including the mitigation/treatment of the common cold.
An important note in FDA's warning letter to Schwabe that might connect to the Boiron case: FDA does not consider a disclaimer that a product is not intended to treat, cure, prevent or mitigate a disease enough to neutralize disease claims that appear elsewhere. The disclaimer proposed in the Boiron settlement might not be enough to keep them out of future legal or regulatory situations.
Despite these cases involving claims issues, AAHP said it believes homeopathic products have a fair and clear opportunity to convey health benefits within the current regulatory framework and enforcement trends:
"Homeopathic medicines have a fair opportunity to convey health benefits; the FDA Compliance Policy Guide provides clear direction regarding how to lawfully market homeopathic products. Manufacturing, labeling, expiration dating, finished product testing, marketing, and sales of homeopathic drugs are all subject to FDA regulation which are functionally identical to the rules for their allopathic counterparts. Good Manufacturing Practice (GMPs) standards for homeopathic and allopathic drugs are also identical."
"All manufacturers and marketers should be aware of the FDAs increasing focus on claims and review their labeling to be certain that claims are consistent with OTC guidelines. The AAHP provides on-going training regarding regulatory compliance topics to homeopathy manufacturers and expects member companies to follow these best practices."
To learn more about homeopathy and AAHP, visit their website.
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