Mar 22 2012
Author’s note: This will inaugurate a series of occasional posts observing the wheels of justice grind slowly over “CAM.”
In a previous post, I posited that CAM practitioners might well subject themselves to liability for the tort of fraudulent misrepresentation. This misrepresentation could be based on both the lack of scientific evidence of effectiveness and the lack of scientific plausibility for their treatments. One example was homeopathy, which, as Dr. Steven Novella aptly stated,
we can summarize . . . by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this.
In the last couple of years five lawsuits have been filed against Boiron, a somewhat prickly company based in France and the world’s largest manufacturer of homeopathic products. In 2011, Boiron had $520,000,000 in sales, although some of this revenue comes from its other products, such as dietary supplements. The plaintiffs are consumers who purchased Boiron’s homeopathic “remedies” and who now allege that they were deceived by Boiron’s false and misleading representations, allegations Boiron denies. Four of the lawsuits are pending in California and one in Illinois.
All of the suits are filed as putative class actions, which generally proceed like this: a plaintiff claims she was injured in a certain manner by the defendant’s conduct and that there are numerous others who were injured in the same, or a similar, way. She asks the court to allow her to proceed with a class action in which she will represent all those other people. In essence, the class members become plaintiffs themselves and are bound by the results of the case. (They can’t, for example, bring their own individual lawsuits.) If the plaintiff is successful, all class members are entitled to relief, including monetary damages.
Delarosa v. Boiron class action
The first suit filed was Gina Delarosa v. Boiron, in 2010. Ms. Delarosa alleged that she purchased Boiron’s Children’s Coldcalm, relying on Boiron’s representations that it was effective in relieving sneezing, runny note, congestion, and other cold symptoms, but that it didn’t work for her family. Her claims are for fraudulent misrepresentation and violation of California consumer protection laws. She sought to represent a class of other California purchasers of Children’s Coldcalm.
In the Complaint, Delarosa first hits hard on homeopathy itself, alleging that:
- A Swiss government study conducted 110 placebo-controlled trials and found that homeopathy is no more effective than placebo.
- The American Medical Association and Great Britain’s National Health Service stated that there is no scientific evidence to support the use of homeopathic treatments.
- “Even homeopathy’s own supporters, such as the National Center for Complementary and Alternative Medicine, admit that ‘[t]here is  no condition for which homeopathy has been proven to be an effective treatment.’” [Empahsis added.]
(And here I’ve been thinking all this time that only hard-core SBM types and their fellow travelers noticed NCCAM’s pro-CAM stance.)
Ms. Delarosa then hones in on Coldcalm itself, alleging:
The homeopathic ingredients in Children’s Coldcam range from various flowers, vegetables, insects, metals, and poison. In order not to poison a user, the dilutions . . . are claimed to be up to 3C and 6C.
. . . a 6C dilution gives one part ingredient to 1 trillion parts of the solution. Dilutions to this extent leave the solution with no trace of the original ingredient.
. . . The idea that a substance could be completely physically lacking and still be effective violates fundamental principles of science. . . . and runs contrary to dose-response relationship established by pharmacology.”
Thus, Ms. Delarosa alleges Boiron’s representations, made on both the package and in other advertising, that Children’s Coldcalm relieves numerous cold symptoms are false, misleading, contrary to established medical authority, and constitute unfair and deceptive business practices. She seeks actual, punitive and other damages, as well as an injunction preventing Boiron from engaging in these deceptive practices.
As might be expected, Boiron opposed the lawsuit’s proceeding as a class action. It also argued, again as might be expected, that the suit was preempted by federal law. Boiron lost on both of these issues, which was a significant victory for Ms. Delarosa and the class of other consumers she now represents. Delarosa v. Boiron, Inc., 2011 U.S. Dist. LEXIS 80562 (C.D. Cal. 2011); 275 F.R.D. 582, 2011 LEXIS 106248 (C.D. Cal. 2011).
Especially interesting was the Court’s ruling on Boiron’s preemption claim. Briefly, under the U.S. Constitution, federal law is the “supreme Law of the Land.” Thus any state law that conflicts with federal law has no effect, and the federal law “preempts” state law on the subject. Very broadly, and without getting into the complexities of the law on preemption, Boiron argued that federal law gave the FDA the exclusive right to regulate homeopathic products and that this preempted the Plaintiff’s state consumer protection law and fraud claims. Had Boiron been effective in its argument the Court would have dismissed the Complaint.
In ruling against Boiron on the preemption issue, the Court was required, for procedural reasons, to accept as true the allegations of the Plaintiff’s complaint. This means that the facts on which the Court relied in making its decision are not findings of fact in the sense a jury would make after hearing the evidence – they are simply what the Plaintiff alleges to be true. On the other hand, it is exclusively up to the courts to determine what the law is, and this Court’s interpretation of federal law regarding homeopathic products highlights their almost complete lack of regulation.
First, by way of background, the Food, Drug and Cosmetic Act [FDCA], enacted by Congress in 1938, defines “drug” to include both prescription and over-the-counter [OTC] homeopathic products recognized in the “Homeopathic Pharmacopoeia of the United States” [HPUS]. According to the FDA, the HPUS is a “compilation of standards for source, composition, and preparation of homeopathic drugs. The HPUS contains monographs of drug ingredients used in homeopathic treatment.” As the Court noted, this means that “the FDA allows a private organization to designate which homeopathic drugs meet certain (and unknown) standards” and are thus eligible for inclusion in the HPUS. [Emphasis added.]
In addition, the Court concluded:
Unlike non-homeopathic OTC drugs, homeopathic OTC drugs, including the Coldcalm product at issue here, are not evaluated by the FDA at all. . . . Although the HPUS describes how these ingredients [in homeopathic products] are prepared for homeopathic use, it does not list the drugs as fit to treat specific symptoms, ailments, or conditions. Instead, the HPUS allows the practitioner or manufacturer to set forth the substance’s indications for use.”
[Citations omitted, emphasis added.]
The Court is unaware of what standards, if any, exists to ensure that homeopathic OTC drugs are safe and effective. The FDA does not impose additional standards for strength, purity, quality, safety, or efficacy on homeopathic OTC remedies, Indeed, the FDA has advised that unless a homeopathic remedy is ‘being offered for use (or promoted) significantly beyond recognized or customary practice,’ federal policies on health fraud do not apply. And perhaps most significant, ‘[a] product’s compliance with requirements of the HPUS . . . does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.”
[Citations omitted, emphasis added.]
As evidenced by the FDA guidance documents . . . the Court concludes that the FDA has largely abdicated any role it might have had in creating standards for homeopathic OTC drugs, and has instead attempted to delegate this authority to the non-governmental organization that determines whether homeopathic substances should be included in the HPUS. In addition, the FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs even if they meet the unknown standards for inclusion in the HPUS.”
The Court also remarked that it could find “no record of any [FDA] investigation of homeopathic remedies due to a reported lack of efficacy.”
To recap, the FDA, the federal agency charged with regulating the safety and efficacy of drugs, has abandoned its authority to do so in the case of homeopathic drugs. Instead, it allows a private organization, employing unknown standards, to decide what homeopathic substances can be used. These substances include insects and poisons. Whatever these standards are, according to the FDA, they do not mean that homeopathic products are safe, effective or not misbranded.
The other lawsuits
In addition to fraud and state consumer protection law claims, other suits against Boiron add federal law breach of warranty claims arising out of purchases of various other Boiron products in addition to Coldcalm. All cases seek to proceed as class actions, although there has been no ruling on this issue yet.
According to the Complaint in Fernandez v. Boiron, products purchased by the Plaintiffs include:
- Arnicare Arthritis, which purports to treat “trauma and muscle soreness” and various types of pain, including “joint pain worsened by heat and slow motion.” Among the ingredients in Arnicare Athritis are “a class B noxious weed, alpine rose, and poison ivy.”
- Chestal, which “loosens thick mucus” and claims to relieve many types of cough, including “barking cough worse at night” and “wet cough associated with the day becoming dry at night.” Active ingredients include “a parasitic insect, wind flower, lung moss, and sea sponge that has been roasted.”
- Quietude, a remedy for, among other things, “restless sleep associated with nervousness” and “sleeplessness associated with worries and exhaustion.” Ingredients of Quietude include “stinking nightshade, nutmeg, purple passionflower, and seeds of the jimson weed.”
As the Complaint points out, none of the ingredients are listed by their common names, but rather by “their more exotic sounding Latin names.”
In Gonzales v. Boiron, Plaintiff is suing over claims made for Oscillo which, according to the Complaint, Boiron advertises as “medicine for headache, body ache, chills & fever,” that will “slow down the spread of germs,” has “a long history of efficacy and safety” and “is the first flu medicine recommended by pharmacists.” Oscillo is advertised as “tak[ing] care of the flu within 48 hours.” But, as the Complaint alleges, the listed active ingredient in Oscillo is Anas Barbariae Hepatis et Cordis Extractum, “a fancy way to hide the truth from the general public, which that this ingredient is actually Muscocy duck liver and heart.”
According to the Complaint, the duck liver and heart “is diluted to 200CK,” which means that for every part of the purportedly active ingredient, “there is 1^399 parts of the inactive ingredient, sugar.” Cleverly, the Complaint spells out this dilution, which results in a ratio of 1:1 with 166 zeros after it. (Assuming I counted all those zeros correctly.) As the Plaintiff points out, the probability of getting one molecule of the active ingredient in a regular dose is “approximately equal to winning the Powerball every week for nearly an entire year.”
An interesting development, in the form of a proposed settlement, occurred last month in one of the lawsuits, Gallucci v. Boiron.
The Plaintiffs in this case seek to represent a nationwide class of all persons who purchased a number of different Boiron products since January 1, 2000. They allege that the active ingredients in these products, even if effective, are so greatly diluted as to be non-existent. Thus, Boiron’s claims regarding the products’ benefits are false and misleading.
The Plaintiffs and Boiron have proposed a settlement of the lawsuit, now pending before the Court for preliminary approval. The settlement would require Boiron to put up $5,000,000 to pay damages, an incentive award to the named Plaintiffs, attorneys fees and costs, plus expenses of administering the settlement. Payouts to claimants are reduced pro rata if $5 million doesn’t cover everything. It would also require Boiron to make changes to its labeling and advertising.
(If Boiron needs any help coughing up the $5 million, although I doubt it does, I suggest it try to claim the $1 million prize offered by the James Randi Educational Foundation to any homeopathic remedy manufacturer who can prove, via valid scientific testing, that its products work.)
Consumers who can produce proof of purchase will get a full refund with a limit of $100 per household. Consumers without proof of purchase will get $10 per product, up to $50 per household.
Because the Court in the Delarosa case has already approved a class of purchasers of Coldcalm in California, the settlement would exclude those persons, but would include all other purchasers of Boiron products in the U.S. as well as California purchases of products other than Coldcalm. This would, in the estimation of the Plaintiffs, include tens of thousands of claimants.
According to the Plaintiffs, between January 2007 and September 2011 (less than 4 of the 11-plus years covered by the settlement), 12 million units of Boiron products were purchased in mass retail stores (which doesn’t include sales in specialty natural food stores or to homeopaths), approximately $13 million in sales per year. It is not clear whether the Plaintiffs are speaking exclusively of the 800 homeopathic products Boiron sells, or are including non-homeopathic products in these numbers. However, because the Plaintiffs themselves included this information in support of their argument that the potential class of purchasers would be very large, it is reasonable to assume they are referring to homeopathic products.
So let’s do the math: If sales are $13 million per year, and the period covered is over 11 years, how can $5 million possibly be adequate to pay out all claims plus attorneys fees, costs and other expenses? Based on unit sales figures included in the proposed settlement (for mass retail sales only), over the 136 months covered by the settlement, 36,040,000 units were sold. If only 10% of these purchases resulted in a claim of $10 each, that would equal $36,040,000 alone. Plaintiffs have already estimated that notice of the proposed settlement to class members will cost almost $160,000. And documents filed in support of the proposed settlement reveal that one of Plaintiff’s attorneys was awarded $595 per hour for his work in another settled class action lawsuit. To me, this just doesn’t add up.
Even if the Plaintiffs were using total sales figures, including non-homeopathic products, let’s assume only one-half of the sales cited by the Plaintiffs are for Boiron’s homeopathic products, and stick with our assumption that only 10% of purchasers make a claim of $10 each. That still results in claims of over $18,000,000.
One task in any class action settlement is figuring out the best way to notify the class members of the proposed settlement so they can make a claim. In this case, something called the “Simmons National Consumer Survey Data” was used to determine how to reach a target audience of class members, described as “U.S. Adults who Trust Homeopathic Remedies (approx. 45 million U.S. adults).” (Sigh.) This led to the conclusion that one appropriate vehicle for notice is an ad in Natural Health Magazine. Well, they got that right. Sample advice on restless leg syndrome from the magazine’s website:
A naturopath says: Homeopathic medicine can ease specific symptoms with diluted doses of plant- and mineral-based remedies.
The treatment: Take Zincum metallicum first because it helps relieve RLS sufferers’ most common complaint—the inability to control their leg and, sometimes, arm movements. If your jerky limbs wake you up at night, try to tame them with Causticum. Use Arsenicum album to ease the creepy-crawly sensations, especially if you also feel restless or cold. But if you’re itchy and hot, try sulphur. Rhus toxicodendron and Kali carbonicum may help, too. With all remedies, start with a 6C potency and take three pellets before bed. You can also buy combination formulas that will treat numerous symptoms.”
6C “potency”? That means the original material is diluted to one part in one trillion. But I digress.
In addition, according to the proposed settlement, Boiron would change its packaging and advertising in two ways. First, “Indications of Use,” which describes the treatment and relief of symptoms or ailments, will bear this “FDA Disclaimer language:”
These ‘Uses’ have not been evaluated by the Food and Drug Administration.”
Sound familiar? It should. This is the infamous Quack Miranda Warning modified for homeopathic products. And, as we know, it has been remarkably effective in encouraging folks to do their own safety and efficacy research when purchasing dietary supplements, a $28 billion dollar a year industry in the U.S. alone. We all know plenty of people who’ve run their own randomized, placebo-controlled, double-blind studies before buying dietary supplements, right?
Second, Boiron will have to include a “Dilution Disclaimer” on packaging stating “C,K,CK and X are homepathic dilutions” and direct the consumer to further information on Boirin’s website. Yet, it appears from this link that this information is already available on the company’s website, although difficult to find. In any event, the proposed information fails to tell the reader the significance of homeopathic dilutions. Thus, under “What does ‘200CK’ mean?” we find:
200CK means that the substance has been homeopathically diluted 200 times at the rate of 1 to 100. Therefore, the original substance has been diluted to 10-200.”
This doesn’t give the reader the valuable information that such a thing is impossible. In fact, that would be a far greater dilution than one molecule in the entire observable universe. One has to assume the consumer would find this helpful in deciding whether to make a purchase.
Boiron will not be required to amend misleading information like this from its website:
Q: Is there any scientific research on homeopathic medicines?
A: An increasing number of scientific studies on homeopathy are being conducted and, in recent years, more than 150 of these studies have been published in medical journals. Clinical research is providing evidence of the efficacy of homeopathic medicines, and basic laboratory research is confirming the biological activity of highly diluted substances and helping the scientific community better understand their mechanism of action.
In sum, if the settlement is approved by the court, Boiron will be required to pay out less than $5,000,000 total to settle claims of everyone in the U.S. (except for some Coldcalm purchasers in California) who, in a period of over a decade, purchased its products. It will also have to add the Quack Miranda Warning to labeling and advertising. Finally, it must give consumers information that doesn’t fully inform them what the homeopathic dilution process really means.
Nor will Boiron have to stop listing ingredients in Latin. So I’ll end with this advice to potential customers of homeopathic products, because, after all, most consumers know Latin, right? And, of course, quidquid Latine dictum sit altum videtur. It is important to remember that cuiusvis hominis est errare, nullius nisi insipientis in errore perseverare. When considering your purchase, de omnibus dubitandum. Just because the package promises a remedy for your ills, et suppositio nil ponit in esse. As to the law of similars and other homeopathic nonsense, quod gratis asseritur, gratis negatur, et hoc genus omne.
Coming soon: “The CAM Docket: Boiron II” and “The CAM Docket: Bach Flower Remedies.”
20 Responses to “The CAM Docket: Boiron I”