April 9, 2013
Homeopathic medicines are protected as legal drugs under the Food, Drug, and Cosmetic Act (FD&C)—which means homeopathic manufacturers can make disease claims. We can thank a brave legislator for insisting on this when the Act was enacted many decades ago. However, unlike conventional drugs, homeopathic medicines do not have to undergo the FDA new drug approval process. Pre-market approval for homeopathic drugs comes from the Homeopathic Pharmacopoeia of the United States (HPUS) monograph, which involves clinical verification of the efficacy of the substance.
Despite federal law, the presence of an HPUS monograph has not protected homeopathic products from a lawsuit under California’s consumer protection law. This is creating an uncertain and expensive business environment for the homeopathic industry and could threaten the marketing of these products in California and other states.
In the 2012 lawsuit of Delarosa v. Boiron, Inc., the plaintiffs alleged that Boiron, the world’s leading homeopathic manufacturer, falsely claimed that its Children’s Coldcalm product would provide relief from cold symptoms, in violation of California consumer protection laws. Boiron argued that the case should not go to trial because the plaintiff’s claims are precluded by federal preemption: the federal definition of a drug, as defined by the FD&C, includes homeopathic remedies like Coldcalm, which are recognized in the HPUS.
The judge denied the preemption. He ruled that Boiron was not protected because the FD&C also contains a preemption exemption for products that aren’t marketed pursuant to FDA approval or final FDA regulation. Trial is set for later this month.
The ruling is significant in that these two sections of the FD&C seem to be contradicting one another. As a result, it creates an opening to claim that the presence of a homeopathic drug in the HPUS is not sufficient under California consumer protection law to prove that the drug is effective.
This isn’t the only California lawsuit attacking homeopathy. Here are some others.
In Galluci v. Boiron, the plaintiffs alleged that Boiron made false claims regarding over twenty-four homeopathic products, that they could effectively treat ailments such as flu, arthritis, sore joints, joint pain, aches, fever, coughs, insomnia, or sleeplessness—again, in alleged violation of California consumer protection laws. Ignoring the principles of homeopathy, the plaintiffs also argued that Boiron’s products are so diluted that they are “effectively nonexistent” and are thus akin to placebo or sugar pills. This is akin to saying that because homeopathic preparations are not like standard drugs, they are fraudulent, exactly the kind of claim that federal protection under the FD&C Act was designed to prevent.
Boiron settled the case for $5 million. It also agreed to place a warning on all its products that “Uses have not been evaluated by the Food and Drug Administration,” and to provide additional data on homeopathic dilution to consumers on their website.
In Allen v. Hyland’s, the plaintiffs alleged that the defendants (Hyland’s and Standard Homeopathy) marketed their homeopathic products as having health benefits while knowing the products had no active ingredients in amounts sufficient enough to cause any beneficial actions, in alleged violation of consumer protection laws. The defendants were unsuccessful in getting the case dismissed, though they did manage to limit the suit to the seven products which plaintiffs actually purchased. The case is still pending.
A couple of things to note here. In none of the cases did the plaintiffs say they were physically harmed. They merely claim that the products did not treat them as they stated they would, and that they suffered minor economic loss by purchasing the product. (So apparently if your cough medicine doesn’t work well enough for you, you get to sue the company!)
Also, the plaintiff in two of these lawsuits is represented by the same attorneys, the Newport Trial Group. The law firm involved in the third case, Marron and Associates, has been accused by the Newport Trial Group of tracking their homeopathic class action suits and plagiarizing them, in an effort to attract clients to their own potential class actions against homeopathic companies.
Did these law firms recruit the plaintiffs? Are they doing this in hopes of getting multi-million dollar settlements, much of which will go to lawyers? Is this just another chapter in the predatory California lawsuits linked to Proposition 65 that we have written about before? Those lawsuits are about supplements, and these lawsuits are about homeopathic medicines, but the pattern seems similar.
The basic premise of the suits—that in the successive dilutions that homeopathic medicines go through to achieve their final potency, there may be no molecules of the original substance left at those concentrations— is not just an attack on these companies. It is an attack on homeopathy itself. Homeopathic researchers have always struggled to explain why their preparations seem to work, even though clinical evidence says it does.
New scientific research may help. Using a laboratory technique called spectroscopy,researchers have found that different homeopathic medicines and different dilutions of the same medicine can be distinguished from each other, even though all should logically contain nothing but water. One explanation for this is that the repeated dilution and succussion (the forceful agitation of the liquid) during classical remedy preparation may break the substance into immeasurably small nanoparticles, that is, “top-down” nanostructures. A novel model for how homeopathic medicines work on living systems has been proposed by researchers Iris Bell, MD, PhD, and Mary Koithan, PhD, RN, CNS. The traditional theory, that some presence remains without actual particles, is of course more controversial. We will return to the scientific questions underlying homeopathy in another article soon.
While homeopathic medicines do not go through the FDA drug approval process, they are absolutely reviewed for safety and effectiveness. The FDA recognizes the monograph published in the HPUS and administered by the Homeopathic Pharmacopia Convention of the United States, a nonprofit standard-setting organization. Currently, 1,286 official homeopathic drug products are recognized by the HPUS. Moreover, homeopathic drugs are subject to FD&C misbranding provisions, and must comply with Good Manufacturing Practice requirements. If homeopathic substance is “new” (that is, used after 1962), manufacturers most commonly gather evidence for safety and effectiveness through a method specifically designed for homeopathics called “proving.”
What is happening in California is a real threat to homeopathy. As these cases proceed, we’ll keep you informed and also work to develop strategies to protect it from predatory lawyers and a hostile court environment.