Over The Counter Drugs

Did you remember that there can be express preemption for over-the-counter drugs?  We sometimes forget too, but there are really good reasons for that.  The Food Drug and Cosmetic Act includes the following provision:

[N]o State or political subdivision of a State may establish or continue in effect any requirement – (1) that relates to

We’re serious – we’re not planning to give a flip answer like “an extortion racket.”  No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?”  (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)).  The

The Reed Smith blogging team has just returned from this year’s annual ACI Drug & Medical Device Litigation conference.  In addition to excessive amounts of eating, drinking, and socializing (now called “networking”), we kept our eyes open for new and interesting topics to blog about.  We were not disappointed.  We learned a lot more regarding preemption of claims involving non-prescription, over-the-counter (“OTC”) drugs, particularly those governed by parts of the FDA’s monograph system that we haven’t considered much before.

We knew, of course, that OTC drug preemption is governed by 21 U.S.C. §379r, which contains not only an express preemption clause, but also a savings clause. Under the preemption clause, tort claims demanding warnings or other information that is “different from,” “addition[al] to,” or “otherwise not identical with” federal labeling requirements are preempted.  However – and it’s a great big however – the savings clause exempts “product liability” claims from preemption. Id. §379r(e).  That doesn’t mean that preemption covers nothing of interest to us.  We’ve discussed at some length how many courts have considered non-personal injury claims to be outside the scope of the “product liability” saving language, and therefore precluded by express preemption.  Most recently, we described a 2014 New Jersey case involving mouthwash that refused to apply a presumption against preemption to the express preemption clause, finding the presumption precedent “confused” and inapplicable.  Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371, 374 & n.17 (S.D.N.Y. 2014).

But what about implied preemption by reason of conflict – specifically the impossibility preemption rationale adopted in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2468, (2013)?  What we heard at the ACI conference sounded good enough to us that we thought we’d investigate it pass along what we found.


Continue Reading Implied Preemption and Monograph Drugs

What follows is a guest post from Reed Smith’s Andrew Stillufsen, an associate in our Princeton office.  He discusses a new FDCA preemption case involving a cosmetic, rather than a drug or device.  As always, Andrew is entitled to all the credit (and any blame) for the contents of this post.

Take it away Andrew, and beware Sir Nose D’voidoffunk.

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The ingenuity of our friends in the plaintiffs’ bar is never-ending and always fascinating, like Cyrano deBergerac’s prodigious proboscis.  For example, this post is about a case brought by some resourceful lawyers who did  not turn up their nose at the possibility of a contingent fee based on the weight of a stick of deodorant.  Perhaps they were inspired by television ads showing average-looking twenty-somethings apply a certain deodorant and instantly becoming the best-looking  (and best-smelling) people in the room.  Perhaps not.  In any case, one thing is certain:  the court did not like what it sniffed after plaintiffs’ claims were unwrapped, and so applied the sweet smell of preemption.  Another thing is also certain:  an overload of olfactory references appear in this post.

Before we nosedive into the court’s preemption analysis, let’s take a look at plaintiffs’ claims.  This putative consumer fraud class action was brought in the Southern District of New York and alleged the usual potpourri  of violations of consumer protection laws, as well as common law claims for breach of warranty, negligent misrepresentation and unjust enrichment. Plaintiffs alleged that the defendant deceived them by (a) misstating the actual weight of usable product in each stick of its deodorant, (b) misstating the total net weight of each stick, and (c) not stating the amount of non-functional slack fill in each stick.  Bimont v. Unilever United States, Inc.,  2015 US Dist. Lexis 119908, at *2 ( S.D.N.Y. Sept. 9, 2015).

Defendant’s motion to dismiss was likely inspired by the fragrance of preemption, since the deodorants at issue were both cosmetics and OTC drugs, and thus subject to the FDCA and FDA regulations.  This blog has posted before on preemption, cosmetics and OTC drugs, including sunscreen twice, and mouthwash.


Continue Reading Guest Post – The Sweet Smell of Preemption Overcomes Plaintiffs’ Stinky Consumer Fraud Claims

During a recent Surfin’ Safari we must have told the DDL Son at least five times to slather on more sunscreen.  Naturally, he engaged in the usual noncompliance-defiance and, naturally, now has a face adorned with a scarlet nose.   Years ago there was a famous commencement address built on the advice that everyone should wear sunscreen.  Sunscreen sometimes makes a cameo appearance in the news of the weird.  We learned that American Army World War II tins of sunscreen and bacon recently turned up on the Salisbury Plain (not so far from Stonehenge).  And we were brought up short when we read that some sunscreen products were recalled because they might ignite.

In this season of Summer Fun and marathon photosynthesis sessions, God Only Knows how ignorant and indifferent so many of us are about the need for sunscreen.  Do you use sunscreen?  (You should – and not just when you are reading the latest Lisa Scottoline thriller at the Jersey Shore.)  Do you know what the SPF (sun protection factor) numbers mean?  (SPF 15 means that only 1/15th of the burning radiation will reach the skin, SPF 30 means only 1/30th will, SPF 50 means only 1/50th will, etc.)  How often should you reapply sunscreen?  (At least every two hours.  Then Do it Again.)  How  much should you use? (Way more than you think.)

Who regulates sunscreen?  (The FDA.  Sunscreen is considered an over-the-counter drug.)

And therein hangs the tale of today’s case, Eckler and Engel v. Neutrogena Corp., — Cal. Rptr. 3d –, 2015 Cal. App. LEXIS 584 (Cal. App. 2d Dist. June 9, 2015).  Two plaintiffs brought slightly different claims that sunscreen labeling was misleading, and those claims were Shut Down by the California appellate court (one that really knows about sunscreen) on grounds of preemption.  Up front in the opinion, the court sums up the issue nicely:  “This case concerns congressional intent with respect to label information on sunscreen products: is it to be determined solely by the federal agency it charged with ensuring uniform labeling for those products, or, in addition, by each state through private civil suits.”  That formulation captures the need for preemption to ensure uniformity and to apply agency expertise.


Continue Reading Fun Fun Fun: Cal Court Dismisses Sunscreen Cases on Preemption

This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy.   We volunteered to photograph the event, because the usual photographer was not able to attend.   And so, we didn’t run – something we used to do, if the definition is expanded to include a shuffle befitting Tim Conway’s character on The Carol Burnett Show.  Instead, we stood at the start line, snapping pictures and gazing longingly at the runners disappearing down the path. Observing our misty countenance, a friend asked us why we didn’t start running again if we missed it so much. In wordless response, we produced our yellowed and crumbling birth certificate.  To which our friend replied, “’Too old’ is a meaningless phrase – you will have to do better than that.”

That is exactly what the Court of Appeal of Louisiana said to the plaintiff in Jean Cooper vs. CVS Caremark Corporation, et al., 2015 La. App. LEXIS 1201 (La. App. 1 Cir. June 17, 2015).  Plaintiff purchased an over-the-counter allergy remedy at a CVS store. Before she used any of the medication, she noticed that the expiration date on the package had passed.  She “did not request a refund, could not remember if she complained to the store, did not take any of the medicine, and, by her own admission, did not suffer any damages as a result of the purchase.”  Cooper, 2015 La. App. LEXIS 1201 at *1-2.

We know what you’re thinking:  “This is the heady stuff of a class action lawsuit.”  Plaintiff had the same thought.  She sued several CVS entities, alleging that they “had a long history of selling out of date medications” and that the expired allergy remedy “had exposed her to health risks.”  Id. at *2 (internal punctuation omitted). Plaintiff requested an award of damages, as well as “injunctive relief to remedy violations of law,” and an order requiring CVS, inter alia, to stop selling expired products and to notify purchasers of “the true characteristics of the products sold.”  Id.   Plaintiff sought certification of the suit as a class action and requested that she be confirmed as class representative.
Continue Reading A “Too Old” OTC Product Does Not A Class Action Make

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.


Continue Reading When More Is Neither Better Nor a Lawsuit

Bexis is pretty pleased this morning.  Almost eighteen years ago, to the day, he filed his first brief with the Pennsylvania Supreme Court challenging the negligence/strict liability dichotomy adopted in Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978) (in a case called Spino).  Over twelve years ago, he filed his first outright “overrule Azzarello” brief (in a case called Phillips).  Well, yesterday the Pennsylvania Supreme Court did precisely that – it overruled Azzarello – unanimously in an opinion written by Chief Justice Castille.  In the end, even the most pro-plaintiff members of the Court (those remaining, anyway) could not stomach the travesty that Azzarello had become.  End of self-congratulatory gloat.

We learned of this development late yesterday afternoon and published a very brief “breaking news” post alerting our readership.  At that point we had not yet read the Court’s entire 137-page opinion, Tincher v. Omega Flex, Inc., No. 17 MAP, slip op. (Pa. Nov. 19, 2014).  Now we have.  While it’s clear that the most obnoxious aspects of the Azzarello regime − the bizarre pre-trial procedure for determining “unreasonably dangerous” as a matter of law, the absolutist negligence/strict liability dichotomy, and the “plaintiff wins” guarantor/any element jury instruction (for those of you not familiar with Pennsylvania law, this is what jurors are instructed: “The supplier of a product is the guarantor of its safety.  The product must, therefore, be provided with every element necessary to make it safe for its intended use, and without any condition that makes it unsafe for its intended use,” Azzarello, 391 A.2d at 559 n.12) – have been disapproved, what’s taken their place is less clear.

On the theory that you can’t beat something with nothing, ever since Phillips Bexis had been advocating the Third Restatement of Torts as an alternative, even though there were significant aspects of the Third Restatement that could hardly be called defense friendly.  Yes, Azzarello was that bad.  The Court, however, did not adopt the Third Restatement in Tincher.  Instead, it has adopted a more mainstream (compared to Azzarello) approach to Restatement Second §402A, that in places is also informed by Third Restatement principles.  We’ll be discussing that in more detail.


Continue Reading Pennsylvania Product Liability – Azzarello Is Dead, Long Live…?

There is no express federal preemption for drugs, right?

Wrong!  Today we expound on a flavor of preemption that we don’t often get around to—express preemption for claims related to non-prescription, over-the-counter drugs.  Under section 379r of the FDCA, no state may establish any requirement that relates to a non-prescription drug and “that is different from or in addition to, or that is otherwise not identical with” a federal requirement.  28 U.S.C. § 379r(a).  The “different from or in addition to” language rings familiar from medical device express preemption that we write on multiple times each month (such as here), and as if that were not clear enough, Congress drove the point home with the “otherwise not identical with” language.

So there you have it.  Express preemption in connection with drugs, albeit not the prescription drugs that usually occupy us, and not without significant exceptions.  The FDA can grant exemptions to the preemption rule under certain circumstances, and the provision does not preempt (1) state regulation of pharmacies or (2) any state requirement that a drug be dispensed only upon by an authorized prescription.  Id. § 379r(b), (c).  The really big exception is that the provision does not preempt product liability claims, Id. § 379r(e), so if we’re faced with claims alleging personal injury attributed to use of an allegedly defective non-prescription drug, express preemption will probably not come into play.

But that does not mean that OTC express preemption does not have teeth.  In Bowling v. Johnson & Johnson, No. 14-cv-3727, 2014 U.S. Dist. LEXIS 155899 (S.D.N.Y. Nov. 4, 2014), the plaintiffs alleged that the label on a popular brand of mouthwash falsely claimed that use would “Restore Enamel.”  Id. at *2.  According to the plaintiffs, loss of tooth enamel is permanent, making it “physically impossible” to restore enamel.  Id.  Based on this allegation, the plaintiffs alleged violations of multiple state statutes (the order does not say which statutes, but we presume they were statutes of the consumer fraud type) and the federal Magnuson-Moss Warranty Act, which governs warranties on consumer products.  Id. at *1.


Continue Reading Express Preemption OTC