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The CAM Docket: Boiron III, et al.

Oh, the irony of it all! Quackery continues its increasingly successful assault on the citadel of medicine, viz: quackademic medicine, integrative medicine, credulous medical journal articles, shruggies, medical society support for CAM provider licensing. Will that nemesis of medical doctors, plaintiffs personal injury attorneys, turn out to be the last defenders of science in a world of health care fraught with so-called alternative medicine?

Maybe not. But the thought did occur to me while reading the Final Judgment and Order entered in Gallucci v. Boiron, the class action accusing the world’s largest manufacturer of homeopathic products of consumer fraud.

Update on Gallucci

As I reported in a previous post, the parties reached a settlement that covers:

  • everyone in the United States (save a few California purchasers party to another class action),
  • who purchased one of over 200 Boiron homeopathic products (basically, every homeopathic product Boiron sells in the U.S.),
  • over a period of about 12 years.

As is typical of settlement agreements, Boiron denies any wrongdoing. On October 31, the U.S. District Court for the Southern District of California entered a Final Judgment and Order approving the settlement. The case is closed and administration of the settlement terms has begun. Purchasers who file a valid claim will get between $10 and $100. The named plaintiffs will get a bonus of $1000 to $3500. All of this comes out of a $5,000,000 settlement fund, an amount which will be reduced after subtracting claims administration and other expenses and attorneys fees (which we’ll get to in a minute). Payments will be reduced pro rata if there is not enough to cover all claims. For reasons I explained in the earlier post, I consider this inadequate. Even more so now, when all of the deductions from the settlement fund are taken into account.

To address what the court described as “concerns that consumers may not be aware that homeopathic products have not been subject to the same FDA scrutiny as allopathic [sic] drugs,” Boiron will have to add the Quack Miranda Warning (homeopathy version) to packaging and some advertisements:

These ‘Uses’ have not been evaluated by the Food and Drug Administration.

Of course, saying that homeopathic products have not been subject to the same scrutiny as “allopathic” drugs is understating it a bit. Homeopathic products actually are subject to no scrutiny whatsoever by the FDA. As a matter of fact, the court in another case found that in practice homeopathic drugs weren’t being regulated by the FDA at all.

FDA regulation, or lack thereof, was not the only possibility for consumer confusion addressed by the settlement. In the court’s own words:

. . . to address Plaintiffs’ concern that homeopathic labels do not sufficiently explain the concept of a homeopathic dilution, Boiron has agreed to provide a Dilution Disclaimer in close proximity to the Drug Facts on each of its labels which shall state: ‘C, K, CK, and X are homeopathic dilutions: see [link created pursuant to para. 4.14 of the Settlement] for details.’ . . . The identified webpage shall provide consumers a more detailed explanation of the dilutions.

Boiron has two years to make the required changes to its packaging. While Boiron’s website currently does not refer to its information on dilutions as a “Dilution Disclaimer,” it does explain dilution and succussion, as well as “the law of similars,” in a series of short videos. Anyone who has no background in biology, physics, chemistry or medicine – in other words, most of the public – will probably find these convincing. (I also found this interesting tidbit under “Boiron In The News:” “Dr. Oz Show Features Self Massage with Arnica Gel to Keep Lymphatic System Healthy.” But I digress.)

Finally, the settlement awards the plaintiffs’ attorneys $1,250,000. Note that this is one of the amounts subtracted from the $5 million settlement fund, as explained above.

Interestingly, Gallucci managed to swallow up another class action, Fernandez v. Boiron, under circumstances the judge in Fernandez found disturbing. Fernandez, which was stayed pending court approval of the Gallucci settlement, will now likely be dismissed, as will Gonzales v. Boiron, another class action stayed pending settlement approval. Because of the breadth of the class and number of products eventually covered by the Gallucci settlement, class members and Boiron products in these other suits are encompassed by the settlement.

You too can be a plaintiff!

At least consumers are ahead of where they were before this litigation, although I imagine this new labeling information will do as much to discourage purchase of homeopathic remedies as the Quack Miranda Warning does to discourage buyers of dietary supplements. Which is to say, not at all. I was reading the order with some consternation, thinking Boiron got off light, when this thought popped into my head: “This is great!” Why? Because once the plaintiffs’ bar figures out they can make some real money suing homeopathic product manufacturers under state consumer protection laws, they will do just that. And they have.

At least two informational websites offer a free evaluation of whether a purchaser of a homeopathic product may have a cause of action against the manufacturer: LawyersandSettlements.com (for all homeopathic products) and Top Class Actions (some manufacturers excluded). The Senators (Ret.) Firm will do the same. And now that the word is out I’ll wager any plaintiffs’ attorney in the U.S. will either take one of these cases or find an attorney who will. Consumers, take note.

As might be expected, one of the law firms currently handling class actions against homeopathic products manufacturers is the Law Offices of Ronald A. Marron ALPC, the very firm representing the plaintiffs in Gallucci v. Boiron. That case did nothing to temper Mr. Marron’s low opinion of homeopathic products. Here’s what he says on the Top Class Actions website:

What is Homeopathy Fraud?

Homeopathy, or homeopathic medicine, is based on the idea that the body has the ability to heal itself, and therefore utilizes extremely low doses of medicine to increase its effectiveness. Many homeopathic remedies are so diluted that little to no molecules of the original substance remain; which some argue makes these medicines ineffective for their advertised use.

Consumers looking for natural remedies turn to homeopathic medicines based on advertisements that they’re ‘Clinically Proven’ to treat ailments, unaware that they’re throwing away millions of dollars each year on worthless placebos. Class action lawsuit attorneys have successfully argued that these companies are falsely advertising their homeopathic products can treat ailments, even though zero or just trace amounts of active ingredients are present.

It’s not just homeopathic medicine that’s falsely advertised, either. Natural and homeopathic diet supplements and beauty products can also scam consumers into believing they’re ‘Clinically Proven’ to work.

Well said! And yes, Mr. Marron, some do indeed argue that these medicines are ineffective for their advertised use, more specifically here, here, and here, among other places.

Here’s a list of some homeopathic products Mr. Marron and his firm have in their sights:

  • Nelsons Homeopathy (Rescue Remedy, Bach Original Flower Remedies, Pure & Clear, Arnileve, H+Care)
  • CVS Homeopathic Products (Flu Relief, Cold Relief, Cold Remedy, Ear Pain Relief)
  • Nature’s Innovation (Naturasil Skin Tags, Bed Bug Patrol, Naturasil Scabies)
  • Boericke & Tafel Cold/Flu
  • Homeolab USA (Kids Relief Cough & Cold)

I’m pleased to note the Marron firm is taking on dietary supplement companies too.

There are at least two class action lawsuits pending against homeopathic manufacturers Hyland’s and Standard Homeopathy. A suit in California involves seven Hyland’s products (Hyland’s Calm Forte, Teething Relief, Migraine Headache Relief, ClearAc, Poison Ivy/Oak Tablets, Colic Tablets and Leg Cramps with Quinine PM). Another lawsuit is pending in New Jersey. According to this April, 2012, news report, a $30 million dollar lawsuit was filed in Canada against Shoppers Drug Mart and Boiron alleging that they have, in their marketing of Oscillococcinum (made from the heart and liver of the Muscovy duck), committed at least 12 violations of consumer protection acts.

Delarosa v. Boiron, covered in two previous posts (here and here), remains pending in the U.S. District Court for the Central District of California. (The Gallucci settlement had to carve out the class represented in Delarosa, California consumers who purchased Boiron homeopathic cold-remedy products, because that class was certified before the one in Gallucci.) Summary judgment motions remain pending and trial is set for April of next year.

Conclusion

On the one hand, Boiron got off really cheap in the Gallucci class action, with a mere $5 million covering the vast majority of U.S. purchasers for 12 years, although that award is only part of the cost of the lawsuit to Boiron. The company will bear their own attorneys’ fees and costs as well as the estimated $7 million it will spend to change its packaging.

On the other hand, if the Delarosa case gets decided on summary judgment in the plaintiffs’ favor, with the judge making findings of fact that Boiron fraudulently sold Coldcalm in violation of the California consumer protection laws, it would be a major public relations debacle, any monetary award aside. Another big embarrassment would be a loss following a jury trial, which could result in a substantial monetary award. And even after a jury trial, only the judge has authority to order injunctive relief, which she could choose to support with written findings of fact underpinning her conclusion that Boiron violated state consumer protection laws. Many “ifs,” but we’ll see.

Even Gallucci won’t stop claims against Boiron over other products it may sell in the U.S. or outside of the 12 years covered by the settlement. Nor will it have any effect on action the FDA, Federal Trade Commission or individual state Attorneys General might take. And it won’t impact suits outside the U.S. or those against other homeopathic product manufacturers. I expect more of these will be filed due to media coverage and attorney advertising.

We haven’t even considered here the possibility of claims against health care practitioners who prescribe or sell homeopathic products. Sellers may be equally liable under consumer protection laws if they knew or should have known of homeopathy’s ineffectiveness. That would, of course, be easy enough to prove. And prescribers are vulnerable to malpractice claims.

Litigation is not the best way to solve problems that should be addressed by regulation. There is no reason the U.S. Congress could not ban the sale of homeopathic products altogether. It certainly could regulate them in a way that substantially affects the ability to market them. But, as in the case of tobacco products litigation, where the government fails in effectively regulating a product unsuitable for human consumption, sometimes litigation is the only avenue left for consumers.

Posted in: Health Fraud, Herbs & Supplements, Homeopathy, Legal, Politics and Regulation

Leave a Comment (15) ↓

15 thoughts on “The CAM Docket: Boiron III, et al.

  1. cervantes says:

    Why not criminal fraud? Last I heard, taking money under false pretenses is a crime.

  2. windriven says:

    “with the judge making findings of fact that Boiron fraudulently sold Coldcalm in violation of the California consumer protection laws”

    I have a crisp clean $20 that says if that happens Boiron will turn it into a “what they don’t want you to know” marketing bonanza.

    As George Carlin once mused: you know how dumb the average guy is? Well by definition, 50% are even dumber.

  3. nybgrus says:

    Funny thing is I also see this as a boon.

    My sister, who is very smart but not a scientist and certainly not a biologist by any means, has sworn up and down by arnica gel (and a few other Boiron products). She is a director at a public relations firm and her very close friends are French and their whole family loves Boiron.

    She once asked me my take on it and, long story short, she appreciated my input but still seemed unconvinced by any sort of fact based discussion on it. She kept reverting to the facts that it is legal, it is licensed, many people use it, and she has seen a few things that convince her of it. She even asked outright if it was such a crock of shit why is it sold and nobody seems to do anything about it. In other words, the imprimatur of legitimacy by the legality of sale and the lack of medical bodies acting against Boiron meant there just must be “something” to it and hey, at least it can’t hurt, right?

    For someone like my sister, pointing out losses in class action suits because of fraud is a significantly more damning piece of evidence than anything scientific I can say. And I reckon there are many people like my sister in the world.

  4. Old_skeptic says:

    @nybgrus: “Homeopathic” arnica gel isn’t extremely dilute, the way homeopathic products are often assumed to be.

    Look at this description of a Boiron arnica product: http://www.arnicare.com/arnicare-gel/ It’s a 1X dilution, and the label says that it’s 7% arnica.

    I don’t know whether arnica actually does anything, but if it does, 7% could be enough to have an actual clinical effect, either good or bad.

    Which is scarier — homeopathic products that are nothing but water or those that actually contain meaningful amounts of active ingredients?

  5. nybgrus says:

    @old_skeptic:

    In my literature review on the topic Arnica montana has no evidence that it does anything and even less that it does what it is purported to do.

    However, in general, homeopathic products with anything besides water and sugar in them are much scarier. Kind of like the Hyland’s Teething Tablets which contained measurable quantities of Belladonna leading to poisonings in babies and a recall of the product.

    Honestly, I can’t begin to understand how people can still allow the sale of and purchase a product where the FDA had to step in and recall it because children were getting hurt (and I believe dying as well) because the ingredient was actually in the pill!

  6. Jan Willem Nienhuys says:

    People might be allergic to Arnica or become allergic by repeated contact!

  7. Narad says:

    In my literature review on the topic Arnica montana has no evidence that it does anything and even less that it does what it is purported to do.

    Oh, I dunno. There’s some evidence regarding bruising, e.g., PMID 20412090, and swelling, e.g., PMID 17572575. Muscle pain didn’t work out so well (PMID 20807867). It’s not completely bonkers as a topical preparation.

  8. nybgrus says:

    @Narad:

    There is always “some evidence” for just about anything. When I look at the literature, however, I don’t just count how many positive and negative abstracts there are (I’ll give you a hint, the latter category is always near zero) and then the column with the most points wins. I found little convincing basic sciences evidence, no veritable mechanisms and few putative ones, and certainly no good studies. To me, and I would think any reasonable scientist, this means the null hypothesis stands unchallenged: arnica does not actually help the healing of bruises nor myalgias. I am certain there are bioactive molecules in there. But that does not equate to topical applications speeding bruise recovery, preventing it in the first place, or helping with myalgias. And a quick read of the link you provided does not provide basic science mechanisms which would lend a hand to the prior probability of these outcomes based on in vitro molecular data.

  9. Amalthea says:

    Unfortunately those teething tablets have been re-issued. I was alarmed when I read the label several years ago and saw what the active ingredient was.
    Admittedly I did have the advantage of having “Belladonna is deadly” quite strongly pointed out several times as a pre-teen and young teen.
    When you’re on a hike in the mountains with a number of adults and a beautiful shrub with brilliant green leaves and deep purple flowers comes into view and at least two adults promptly point to it and say “That’s Monk’s Hood. Don’t touch it! It’s deadly poison with even one touch!” the message gets stuck pretty firmly in your head.

  10. fxh says:

    I’ve always been curious. Has the Homeopathic “community” or “authorities” ever sued anyone for fraud or misrepresentation?

    If I was to advertise small bottles of tap water as homeopathic remedies and sell them and I knew them to be just tap water would the homeopathic governing bodies take me to court over misrepresentation?

    On the other hand if I believed that by spinning them around in my lettuce/salad spinner that I had imbued them with special curative properties – would that be a defence?

    Or if I believed that the bottles of tap water had a special connection to my mind and healing vibrations would that be a defence?

  11. Narad says:

    I found little convincing basic sciences evidence, no veritable mechanisms and few putative ones, and certainly no good studies.

    I didn’t go so far as to claim that the studies lying around are compelling in and of themselves. Nonetheless, given that there does seem to be a folk tradition and that transdermal absorption isn’t out, I’m willing to grant it a prior plausibility above the vanishingly small value of homeopathy proper. If nothing else, I’ve encountered the peculiar Journal of Negative Pharmaceutical Results, I suppose.

  12. qetzal says:

    fxh:

    On the other hand if I believed that by spinning them around in my lettuce/salad spinner that I had imbued them with special curative properties – would that be a defence?

    Sadly, in the US, the answer is essentially “yes.” Congress, in its infinite(ly diluted) wisdom, enshrined the Homeopathic Pharmacopoeia as an official compendium of legally recognized ingredients, methods, and products. So, yes, it really is a defense that your water has been through a magic ritual.

  13. nybgrus says:

    @narad:

    Yes, I agree. It does have actually vastly more prior probability than a standard homeopathic preparation (which seems to not matter much since just about anything, no matter how it was actually processed, can be called homeopathic).

    I was commenting specifically on Arnica since my sister had asked me about it around a year ago and I actually looked into it back then.

  14. Jann Bellamy says:

    According to the American Association of Naturopathic Physicians, naturopathic licensing bills will be introduced in 11 states in 2013, although they have named only 8 of these states: West Virginia, Arkansas, Florida, Colorado, Massachusetts, N.Y., Virginia and Maryland. A bill was recently filed in Arkansas:
    http://www.arkleg.state.ar.us/assembly/2013/2013R/Pages/BillInformation.aspx?measureno=HB1011.

    Their goal in states where naturopaths are currently licensed, but have less than primary care physician scope of practice, is to keep coming back to the legislature until they get full scope. Licensing is extremely important to them now because they can argue that, under the ACA, insurance companies must cover their services in states where they are licensed. I’ll be writing more about this during 2013.

    In the meantime, if you live in one of these states, or know someone who does, you would do well to educate your legislators about naturopaths. Otherwise, naturopaths get away with misleading statements about their education, training and treatments because there is no one to contradict them. If you are a health care professional, you can make sure your profession organization knows about the threat of naturopathy and urge organized opposition.

  15. Jann Bellamy says:

    Oops — meant to post this comment on Mark Crislip’s post about naturopaths, so I just did, but I guess you can’t say this stuff too often anyway.

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