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Today’s case, Bradley v. CVS Pharmacy, Inc., 2021 Cal. App. LEXIS 451, 2021 WL 2176797 (Cal. Ct. App. May 28, 2021), is not about drug or device product liability, but its discussion of deference to administrative agencies is interesting. There are several different but closely related doctrines that either require or permit judicial deference

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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.Continue Reading Injunctive Relief Claims Lead to Defense Opportunities

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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.Continue Reading Putting A Lotion Claim In The Primary Jurisdiction Basket

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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).Continue Reading How To Handle Homeopathy?