The National Center for Homeopathy, a non-profit organization “dedicated to promoting health through homeopathy,” describes homeopathic medicine as a “safe, gentle, and natural system of healing” that is “extremely safe to use” and “has none of the side effects of many traditional medications.” They also say that homeopathic remedies are “made from natural substances” and are “FDA regulated.” According to the website, homeopathy is based on, among other things, the “Law of Similars,” meaning that “a medicine can cure a sick person if it can cause a similar sickness in a healthy person.” In addition, the “Minimum Dose” principle involves administration of the smallest amount of medicine needed. This is achieved by dilution of active ingredients to create remedies.
The National Institutes of Health, for one, does not seem to be buying it (probably literally as well as figuratively), stating that “there is little evidence to support homeopathy as an effective treatment for any specific condition.” The NIH specifically notes that: “key concepts of homeopathy are inconsistent with fundamental concepts of chemistry and physics;” “[m]any homeopathic remedies are so diluted that no molecules of the original substance remain;” “some products labeled as homeopathic can contain substantial amounts of active ingredients and therefore could cause side effects and drug interactions;” and, the FDA “does not evaluate [homeopathic] remedies for safety or effectiveness.”
Nevertheless, the FDA recognizes that the homeopathic drug market recently became “a multimillion dollar industry in the United States.” Indeed, there are numerous over-the-counter homeopathic remedies that purport to treat countless symptoms and ailments, many of them intended for infants and children. There are U.S. and foreign manufacturers that manufacture and market homeopathic remedies.
The increasing popularity of homeopathic remedies for infants and children comes as no surprise given the FDA’s 2008 public health advisory recommending that no cough or cold products be used for infants under age 2 because of safety risks. After the advisory, drug manufacturers voluntarily removed over-the-counter infant cough and cold products from the market and re-labeled children’s cough and cold products to state: “do not use in children under 4 years of age.” While FDA advises that parents turn to cool mist humidifiers, saline nose drops, fever reducers and hydration, parents seeking symptom relief may try homeopathic remedies which are marketed as “safe” choices for infants and young children.
Is this starting to sound like an area that might breed some litigation? If your answer is “yes,” you are correct. Specifically, companies have seen putative class actions initiated by consumers. And, these plaintiffs have been making some headway recently.
Back in April, a California federal district court judge certified a nationwide class of purchasers in a lawsuit against homeopathic remedy manufacturers, Standard Homeopathic Co. and its subsidiary Hyland’s Inc. See Enzo Forcellati, et al. v. Hyland’s, Inc., et al., CV 12-1983-GHK, slip op. (C.D. Cal. April 9, 2014). The plaintiffs allege that the defendants’ homeopathic remedies are ineffective and are misrepresented as having medicinal value. The certified class includes anyone who purchased any of 5 of defendants’ homeopathic cough and cold remedies for children on or after March 8, 2008. The class was certified with respect to plaintiffs’ claims for violations of the Magnuson-Moss Warranty Act, California’s consumer protection laws, unfair competition and false advertising laws, as well as breach of express warranty.
Defendants had attempted to prevent class certification by arguing that plaintiffs failed to establish commonality and typicality, but the court disagreed. With respect to commonality, the court concluded that “[i]f Plaintiffs can prove that homeopathy is a ‘pseudoscience,’ as they claim, and that Defendants’ products therefore uniformly do not perform as advertised, then the putative class will be entitled to relief . . .” Slip op. at 10. And, the court explained that there was no issue with respect to typicality because “the extent to which Plaintiffs’ children differ from absent class members is immaterial to Plaintiffs’ ability to prove the general inefficacy of homeopathy.” Id. at 12.
More recently, before a different California federal district court judge, a nationwide class of purchasers largely won their bid for class certification in a lawsuit against the same defendants. See Kim Allen et al. v. Hyland’s Inc. et al., No. 2:12-cv-01150, slip op. (C.D. Cal. Aug. 1, 2014). The plaintiffs in Allen allege that 12 of the defendants’ products (all different from the products at issue in Forcellati), including some intended for infants and children, are mislabeled and ineffective. According to the plaintiffs, the remedies’ active ingredients are overly diluted and also include synthetic chemicals or elements despite being labeled “all natural.”
After extensive briefing and a hearing, the court certified a class of purchasers, but excluded two of the contested products and some of plaintiffs’ claims such as breach of implied warranty. The court flatly rejected defendants’ challenges to certification. Defendants had, for example, disputed that typicality had been established, but the court held that “[t]o the extent that the named plaintiffs differ from the absent class members [ ], such differences do not affect their ability to prove that Defendants’ products cannot possibly work because the active ingredients are so diluted as to be useless.” Slip op. at 22. And, with respect to defendants’ challenge to commonality, the court quoted and followed the Forcellati decision and explained that: “the question of whether ‘extremely low doses’ of a substance can ‘produce real and measurable effects’ is a common question that drives the resolution of this litigation.” Id. at 19-20. Thus, the court certified a class including all purchasers of 10 of defendants’ products from February 9, 2008 to the present with respect to the same types of claims certified in the Forcellati case.
Given that these certified classes are challenging the very premise of homeopathy, other homeopathic remedy manufacturers should monitor these cases closely. But the implications of these cases are broader than just homeopathy – all consumer product manufacturers potentially could be impacted by these class certification and labeling issues that have arisen and will continue to play out.