It’s not all that common, but every now and then our opponents feel their oats and seek injunctive relief – usually against the continued marketing of an FDA-approved product.  A state-law plaintiff seeking such injunctive relief should bring about an almost Pavlovian response from the defense.  This is an opportunity to make headway on preemption and related issues.  Courts don’t like to be in the business of invoking state law to override an FDA approval decision.  We can think of five cases that fit the pattern:  Bernhardt v. Pfizer, Inc., 2000 WL 1738645 (S.D.N.Y. Nov. 22, 2000); In re Paxil Litigation, 2002 WL 31375497 (C.D. Cal. Oct. 18, 2002); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015); Herazo v. Whole Foods Market, Inc., 2015 WL 4514510 (S.D. Fla. July 24, 2015); and most recently, Stevens v. Boston Scientific Corp., ___ F. Supp.3d ___, 2016 WL 328739 (S.D.W. Va. Jan. 26, 2016).

The first two of these cases, Bernhardt and Paxil, are both notable because they bothered the FDA enough that the government intervened, filing amicus curiae briefs urging preemption and primary jurisdiction as grounds for the respective courts to reject the proposed injunctions.  In Bernhardt, the plaintiffs sought injunctive relief under state law to force a manufacturer to make changes in its FDA-approved labeling and also to issue “Dear Doctor” letters that the FDA had not required.  The court agreed that the FDA had primary jurisdiction over what a drug’s labeling (and DHCP letters) should say.  “Under the doctrine of primary jurisdiction, a district court may refer a matter within its original jurisdiction to the appropriate administrative agency if doing so will promote proper relationships between the courts and administrative agencies charged with particular regulatory duties.”  Bernhardt, 2000 WL 1738645, at *2 (citation and quotation marks omitted).  Whether the results of a new study required a labeling change or a “Dear Doctor” letter are squarely within the expertise of the FDA:

[P]laintiffs ask this Court to determine, on the basis of presumably scientific and medical principles to be developed at an adversary preliminary injunction hearing, that the [study] findings warrant a notice to all [drug] users and their physicians.  The FDA, not this Court, has the relevant expertise.


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When Jame Gumb urged his captive to put lotion on her skin, he was not concerned with improving its firmness.   While Buffalo Bill from “Silence of the Lambs” may not be who most would think about when reading Franz v. Beiersdorf, Inc., No. 14cv2241-LAB (RBB), 2015 U.S. Dist. LEXIS 102784 (S.D. Cal. Aug. 5, 2015), the serial killer with an obsession for skin did come to our mind.   Franz involves a purported class action over a lotion that allegedly violated consumer protection laws by how its labeling represented its ability to firm skin and allegedly violated California unfair competition law in being marketed without an approved NDA by FDA.   The defendant’s motion to dismiss made a few arguments, but we are most interested in the argument that primary jurisdiction requires dismissal or stay of the unfair competition claim.

If you were to peruse our primary jurisdiction posts, you might notice the cases typically involve federal claims that are not subject to preemption (as state law claims may be).   We have posted before on California courts evaluating preemption in the context of consumer protection and unfair competitions claims for sunscreens.  Other than the timing of when sunscreen and skin lotion typically get applied—and the absence of an obvious serial killer reference for the former—at first blush, the products seem similar enough that we might have expected preemption to be the argument raised against the state law claims in Franz.  It probably should not have been a surprise that FDA treats some skin lotions as cosmetics and others as drugs—whereas sunscreens are regulated as cosmetics—so the regulatory framework is different.   Without digging too deeply, however, it still seems like an allegation that the defendant should be liable under state law for selling a product in violation of the FDCA—without FDA coming to that same conclusion—walks right into the sort of preemption articulated in Buckman.


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Search for “homeopathy” on the Internet, and one quickly discovers that this particular form of “alternative medicine,” does not have the greatest
reputation.  Wikipedia, not always an unimpeachable source, but usually OK for our purposes, has a less than stellar description of the practice:

Homeopathy is a pseudoscience, which is a belief that is incorrectly presented as scientific, but is ineffective for treating any condition. . . .[H]omeopathic preparations . . . involve[] repeatedly diluting a chosen substance . . . well past the point where no molecules of the original substance remain. . . .  Homeopathy is not a plausible system of treatment, as its axioms about how drugs, illness, the human body, liquids and solutions operate are contradicted by a wide range of discoveries across biology, psychology, physics and chemistry made in the two centuries since its invention. . . .  The continued practice of homeopathy, despite a lack of evidence of efficacy, has led to it being characterized within the scientific and medical communities as nonsense, quackery, and a sham.

Wikipedia, “Homeopathy” (Numerous footnotes omitted).  Considerably more along the same lines may be found at Quackwatch.

So why talk about homeopathy here?  Because unlike many other controversial alternatives to modern medicine, homeopathic remedies are still around,
courtesy of Congress when it enacted the Food, Drug & Cosmetic Act.  In the Act, Congress defined a “drug” so as to include “articles recognized in the . . . official Homœopathic Pharmacopœia of the United States.”  21 U.S.C. §321(g)(1); see 21 U.S.C. § 351(b) (“when a drug “is labeled and offered for sale as a homeopathic drug, . . . it shall be subject to the provisions of the Homeopathic Pharmacopeia of the United States”); 21 U.S.C. §360eee(13) (defining “product” as including “homeopathic drugs marketed in accordance with applicable guidance under this Act”).  The FDA has issued standards for the labeling of homeopathic products authorized by the statute.  See generally Compliance Policy Guide §400.400 (setting forth homeopathic labeling requirements).


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Coco Chanel said that nature gives you your face at 20, but you earn your face at 50.  Perhaps that is not so different from Mark Twain’s theory that one’s wrinkles should merely be monuments to smiles.  Those platitudes do nothing to stop people from trying to escape or cover up the effects of aging on our countenances.  It is a big business.  Revlon markets cosmetics under the brand name of “Revlon Age Defying with DNA Advantage.”  It is hard to conceive of anything that is more redolent of puffery.  Nevertheless, plaintiffs brought a class action alleging, essentially, that the marketing of the product is replete with lies.  The court’s decision in Elkind v. Revlon Consumer Prods. Corp., 2015 U.S. Dist. LEXJS 63464 (EDNY May 14, 2015), is the veritable mixed bag.

The case was brought as a class action alleging false and misleading advertising in violation of N.Y. Gen Bus. Law sections 349 et seq., and Cal. Bus. &Prof Code § 17200 et seq., as well as breach of warranty, unjust enrichment, negligent misrepresentation, and fraud.  There is bicoastal ambition behind this lawsuit.  The plaintiffs claim that the product’s name and marketing fooled them and all reasonable consumers into believing that the products would “interact with the skin’s DNA, perhaps on a cellular or molecular level, to provide scientifically-enhanced therapeutic benefits that reverse, minimize, slow, or otherwise ‘defy’ the process of aging.”  The named plaintiffs, who purchased a foundation and concealer from a CVS retail store, understood the product’s name and marketing to suggest “that the products contained something very scientific and special having to do with DNA.”   The plaintiffs alleged that they relied on those misrepresentations at the time of their purchase, and as a result paid more for the products than they otherwise would have.

More specifically, the plaintiffs alleged that the phrase “Age Defying  with DNA Advantage” on the products’ labels and in other marketing duped them into believing that the product would favorably interact with their DNA on a molecular level.  The plaintiffs also asserted that because the phrase “Age Defying with DNA Advantage” manifests an intent that the products be used to manipulate the cells, the products are over-the counter drugs, as defined by the Federal Food, Drug, and Cosmetic Act (FDCA).  As such, the products would be mislabeled because they do not comply with the FDCA’s drug labeling requirement that all of a drug’s ingredients be listed, and they therefore violated New York and California laws prohibiting the unlawful sale of products.  The court helpfully breaks down the plaintiffs’ claims into two categories:  “Deceptive Advertising Claims” and “Mislabeling Claims.”


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This post comes from the Cozen O’Connor side of the blog only.

City of Chicago v. Purdue Pharma L.P., 2015 U.S. Dist. Lexis 60587 (N.D. Ill. May 8, 2015), deals with an effort by the City of Chicago to recover payments it made to drug companies on opioid prescriptions for City employees (and retirees) covered by HMO, PPO and worker’s compensation plans. Id. at *9-11.  Chicago claimed that it should get its money back because the drug companies misrepresented that the opioids were effective for more than short-term treatment of cancer pain.  The City lost—at least for the time being.

The City claimed that the drug companies had mounted a coordinated campaign to use key opinion leaders to write, speak and create guidelines on long-term opioid therapy, use professional and patient advocacy groups as marketing tools, develop and support medical journal articles on long-term opioid therapy, misuse CME programs to market such long-term therapy, and more.  In this campaign, according to the City, the drug companies overstated the effectiveness of opioids, downplayed the effectiveness of alternatives, and hid or understated risks such as addiction.  Id. at *4-9.  The City made common law fraud, conspiracy and unjust enrichment claims, and claims under certain Chicago municipal codes that, among other things, incorporated the Illinois Consumer Fraud and Deceptive Businesses Practices Act. E.g., Chicago Municipal Code § 2-25-90.  Chicago asked for its money back and, as is often the case, hired private counsel to help them get it.  Read here for our take a number of years ago on efforts by municipalities to recover these and other types of costs.


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This post is from the non-RS side of the blog only.

I didn’t know that the SPF value for sunscreens can reach higher than 100.  But they can.  As someone of Irish descent, someone who can burst into flames at the hint of sunlight like a John Carpenter vampire, I should have known that.  For instance, Coppertone markets a product called SPORT SPF 100+. I’m going to buy a case.

Now, some plaintiffs’ attorneys will tell me that I’m wasting my money.  Or, they might tell me that I have a lawsuit.

Or maybe I don’t.  Plaintiff Danika Gisvold brought a class action claiming that she paid an extra dollar for Coppertone SPORT SPF 100+ at Walmart, but it didn’t provide any more protection than Coppertone products with only an SPF value of 50 .  Gisvold v. Merck & Co., Inc., 2014 WL 6765718 (S.D.Cal.) (S.D. Cal. Nov. 25, 2014).  She thought she was getting double the protection, but she wasn’t.  She sued to get her dollar back and an order that Merck should issue a corrected label and corrective advertising.  Id. at *1.


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Yesterday the Supreme Court heard oral argument on the Pom Wonderful case.  One thing we’ve learned is that Justice Kennedy doesn’t seem to like Coke’s label for its juice:

JUSTICE KENNEDY:  Is it part of Coke’s narrow position that national uniformity consists of labels that cheat the consumers like this one did?

MS. SULLIVAN: