Over The Counter Drugs

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 question of “what is product liability” is of interest to us primarily, but not exclusively, because of 21 U.S.C. §379r(e), which creates an exception for “product liability law” to what is otherwise a rather broad preemption provision governing over-the-counter (also called “monograph”) drugs.

We wrote a post in the early days of the blog – 2008 – about that particular provision, entitled “Preemption Without a Prescription,” where we discussed cases that, up to that time, had addressed the scope of §379r(e)’s saving clause.  That boundary of that clause, as we explained it then, was that “suits for purely economic loss – primarily, but not exclusively, brought under state consumer protection statutes – are not ‘product liability’ actions.”

That’s still true.

We’re not repeating the 2008 post, but we will update it.  Here is a list of cases not discussed in that post, which likewise hold that preemption defeats OTC drug litigation that does not involve personal injury claims:  Wiltz v. Chattem, Inc., 2015 WL 3862368, at *1-2 (C.D. Cal. May 8, 2015); Bowling v. Johnson & Johnson, 65 F. Supp.3d 371, 376-77 (S.D.N.Y. 2014); Gisvold v. Merck & Co., 62 F. Supp.3d 1198, 1202-03 (S.D. Cal. 2014); Crozier v. Johnson & Johnson Consumer Cos., 901 F. Supp.2d 494, 503-05 (D.N.J. 2012) (discussing scope of §379r(e)); Delarosa v. Boiron, Inc., 818 F. Supp.2d 1177, 1188 n.7 (C.D. Cal. 2011) (discussing scope of §379r(e)); Eckler v. Neutrogena Corp., 189 Cal. Rptr.3d 339, 357-61 (Cal. App. 2015) (discussing scope of §379r(e)).

Thanks to this recent blogpost, however, we’ve become aware of another way that the definition of “product liability” is important.  Down in Texas, they have a unique indemnification statute, Tex. Civ. Prac. & Rem. C. §82.002(a) that provides:

A manufacturer shall indemnify and hold harmless a seller against loss arising out of a products liability action, except for any loss caused by the seller’s negligence, intentional misconduct, or other act or omission. . . .

We’d vaguely heard of this statute before, in connection with a case, Hadley v. Wyeth Laboratories, Inc., 287 S.W.3d 847, 849 (Tex. App. 2009), which we liked because it held that prescribing physicians weren’t “sellers” of the drugs they prescribed, which means they can’t be sued for strict liability.

But §82.002(a) also means that, in Texas, the ability of an intermediate seller to recover indemnity (including counsel fees) requires that the underlying action to be one for “products liability.”  That’s where the blogpost comes in.  It discussed a recent case, vRide, Inc. v. Ford Motor Co., 2017 WL 462348 (Tex. App. Feb. 2, 2017), that also addressed the definition of “product liability.” vRide involved an indemnity claim brought by a lessor of a motor vehicle from the defendant, which manufactured the vehicle.  The underlying claim had not been for strict liability, but rather for misrepresentation – that the vehicle did not have the attributes that the original defendant (the lessor) claimed that it did.

The court in vRide held that a misrepresentation claim did not fall within the meaning of “product liability”:

The [plaintiffs’ complaint] did not allege that the [product] was unreasonably dangerous, was defective by manufacture or design, was rendered defective because it lacked certain safety features, or was otherwise defective. Instead, the petition alleged that [defendant] represented [that the product] had certain safety features when in actuality [they] did not have those safety features. . . .  In short, the [complaint] did not contain allegations that the damages arose out of personal injury, death, or property damage allegedly caused by a defective product.

2017 WL 462348, at *7. We can imagine situations in which this definition could come in useful in litigation involving OTC preemption, since it excludes from “product liability” even some actions involving (as did vRide) personal injury.

The most significant hypothetical involves a situation where the plaintiff’s injuries were caused by a generic OTC drug. In that situation, given the broad scope of preemption available in generic drug cases, one could expect plaintiffs to attempt to assert innovator liability against the branded drug manufacturer.  But innovator liability is based (like vRide) on the (we believe phony) proposition that “misrepresentation” is not “product liability” and thus can extend to non-manufacturers.  But if misrepresentation is not “product liability,” then the savings clause in §379r(e) would not apply, and innovator liability claims would be expressly preempted whether or not they involved personal injury. vRide would thus be precedent in favor of preemption.

That would be a good thing.  And so is cross-fertilization – where a definition in a completely unrelated statute can be utilized in support of preemption.

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.

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

As large swaths of the country continue to get pounded by a variety of winter precipitation, we know that there are many over-the-counter cold and flu preparations being consumed by our readers. We assume many of our readers have minor children who are taking the pediatric versions of these preparations after suitable review of the labeling by their respective parents.  The labeling does not just tell the reader how much to take or how often to take it, but discloses actual risks.  Other than to whom the manufacturer’s duty to warn runs, the causes of action available for plaintiffs suing over OTC drugs are pretty much the same as for prescription drugs.  Some risks of OTC medications rival risks of prescription drugs, in terms of severity of the injury if not its frequency.  The risk we seem to post about most often in OTC drug cases is Stevens-Johnson Syndrome (and its related Toxic Epidermal Necrolysis), which is usually quite nasty.

The risk, however, is not new.  Without laying out a comprehensive labeling history, we can say that OTC ibuprofen-containing preparations have had warnings since before 2006, when the labels for adult and pediatric versions were revised in connection with FDA action on a Citizen’s Petition.  Yet, we still see cases where plaintiffs sue over SJS they say they got from ibuprofen in pediatric OTC cold preparation.  As we have said many times, we have a hard time seeing the basis for imposing liability on a drug manufacturer for an injury the risk of which was adequately described in the label, especially a label the FDA specifically revised in terms of how that risk was described.  We have also said, particularly since Bartlett, that claims based on the need to change one drug to a different drug, to the extent they could be cognizable under any state’s design defect law, should be preempted.  We posted last year on Newman v. McNeil Consumer Healthcare, No. 10 C 1541, 2013 U.S. Dist. LEXIS 113440 (N.D. Ill. Mar. 29, 2013), a case involving warnings and design defect (and other) claims over SJS from a pediatric OTC ibuprofen preparation.  In decrying that court’s ruling allowing design defect to proceed based on the contention that a different drug was an alternative feasible design, we wrote famously—checking to see if our readers’ collective ego-meter is working—“A cat is no more an alternative design of a dog than acetaminophen is an alternative design of ibuprofen.”

In Hunt v. McNeil Consumer Healthcare, Civ. No. 11-457, 2014 U.S. Dist. LEXIS 14263 (E.D. La. Jan. 17, 2014), we see a case with the same product and similar allegations that cites the Newman decision—but not our post.  Hunt involved alleged SJS from use of the product in February 2010—the date is not mentioned in this decision—and allegations of failure to warn and design defect under the Louisiana Product Liability Act. (We are not picking on Louisiana. We are told we have enjoyed some of our trips to the state.)  Defendants moved for partial summary judgment on the design defect claim and to exclude one of plaintiff’s experts.  We pause here to express some confusion.  The defendants did not move on the warnings claim even though the product was used with the FDA-mandated SJS warnings.  The partial motion for summary judgment was said to be “Granted in Part,” but it looks to us like it was denied except that plaintiff “clarified” that she “intends to offer evidence” only as one of three purported alternative designs identified by one of her experts.  Id. at **7-8.  (We wonder if plaintiff dropped acetaminophen as an alternative design because of the August 2013 FDA announcements about acetaminophen and SJS.)  The elephant in the room on design defect for a drug is impossibility preemption, but the court pointed out in a footnote that Defendants did not assert it and the court would not consider it sua sponteId. at *8 n.1.  And, while part of this decision considers a motion to exclude one expert who opines on causation and damages, the Defendants apparently did not move on the expert who was opining on warnings and design defect.  That expert, Randall Tackett, is a fairly well-known and well-worn shill for the other side, who we have mentioned here and here.  As discussed below, his opinions that helped create the genuine issues of material fact to defeat the motion for partial summary judgment might have been excludable under strong Fifth Circuit Daubert law.  Maybe there is more going on in this case than is apparent from the decision itself or maybe the Defendants will get another shot to raise preemption and/or knock out Tackett.

So, now that our expression of confusion has given away the result in Hunt, we can return to our analysis.  The court correctly assigned the burden on plaintiff to prove that “a safer alternative design existed at the time” the plaintiff’s product was manufactured and “that the risk avoided by using the alternative design (magnitude of damage discounted by the likelihood of its occurrence) would have exceeded the burden of switching to the alternative design (added construction costs and loss of product utility).”  Id. at *7 (quoting Roman v. W. Mfg., Inc., 691 F.3d 686, 700-01 (5th Cir. 2012)).  The alternative design that plaintiff urged, based on Tackett’s testimony, was dexibuprofen, which, as we explained before (but Hall did not), is the right-sided stereoisomer of racemic mixture ibuprofen.  The rub is that FDA rejected a New Drug Application for dexibuprofen in 1994 and it cannot be marketed in the U.S., let alone sold OTC.  Tackett’s opinion that “FDA would now grant an NDA for dexibuprofen” was unchallenged, even though—preemption aside—it is rank speculation and does not, as characterized, go to the potentially relevant issue.  Id. at *11.  The real question was whether a pediatric OTC containing dexibuprofen would have been approved in time for it to be on the shelves by February 2010.  Without a long regulatory discussion, where the active ingredient is not already legally marketed in any form, obtaining pediatric OTC approval would be harder than a “standard” NDA, which is not easy even without a prior rejection.  Presumably, Tackett’s guess was really as to this question and plaintiff had evidence from him or someone else satisfying the risk/burden part of LPLA design defect law. That meant the question for the court was a straight legal one:  Does the requirement that “[t]here existed an alternative design” mean that the alternative design had to have been legal?

The court concluded that the Louisiana legislature’s choice of “existed” was a rejection of requiring that the alternative design have been “feasible,” as is the law in many jurisdictions.  Id. at **8-9.  According to a law review article by a lawyer who helped draft the LPLA, “existed” really just means that someone somewhere had “conceived” the alternative design such “that the manufacturer had a realistic choice as to design” (between what was used and the identified alternative).  Id. at **9-10.  Based on this, the court concluded that a drug not on the market could be an alternative design if there was “evidence” like what Tackett offered.  Id. at *11.  Significantly, as far as we know, this non-FDA-approved alternative design theory has been rejected by every state court judge and every appellate decision to have considered it.  See Ackley v. Wyeth Labs., Inc., 919 F.2d 397, 401-02 (6th Cir. 1990) (applying Ohio law); White v. Wyeth Labs., Inc., 533 N.E.2d 748, 753-754 (Ohio 1988); Militrano v. Lederle Labs., 769 N.Y.S.2d 839, 847-848 (N.Y. Sup. 2003), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006); Totterdale v. Lederle Labs., 2008 WL 972657 (W.Va. Cir. Mar. 19, 2008).

The court did not address the more fundamental question of how a different drug, approved or not, can be an alternative design, on which this plaintiff should lose under the LPLA.  See Theriot v. Danek Med., Inc., 168 F.3d 253 (5th Cir. 1999). If the idea is to test the reasonableness of a manufacturer’s choice—which sounds like negligence not strict liability—then the real choice of which drug to pursue happens years before any marketing application would be filed.  There may not be a real option of pursuing a product with the other drug if rights to its development are held by someone—like a competitor—who does not want to share under any terms.  (If the rights bear a Dr. Evil-like price of $100 billion, then is the theoretical choice still a “realistic” one?)  Even ignoring preemption, drugs are not like products where the manufacturer really has sole control over the design (e.g., adding a safety guard to a power tool). So, we do not see how “a realistic choice as to design” opens the door to liability for developing and selling one drug instead of another.  This leap was done by a federal court predicting what Louisiana courts would do, but without citing a single relevant Louisiana decision.  The decision did cite Newman, applying Illinois law, and a federal case applying Texas law, but none of the many decisions saying a different drug—even a stereoisomer—is not an alternative design.  This is not a proper result under Erie v. Tompkins.

By comparison, the rest of the decision was fairly restrained and narrow.  The plaintiff offered a burn surgeon to opine on general causation, specific causation, and damages.  He could not offer general or specific causation opinions because he merely parroted what other experts said without independent investigation of the issues. Hunt, 2014 U.S. Dist. LEXIS 14263,  **16-17.  The court actually cited some pretty good law Daubert law—we told you it was there—in dispensing with the opinions. The challenge to his damages opinions was apparently limited to qualifications and easily rejected.  Id. at **19-21.  A pretty obvious result. Nothing to see here.  Go play in the snow.  With your dog or, alternatively, your cat.

Do you remember way back yesterday when we posted on Daubert rulings from an OTC pediatric ibuprofen SJS case?  The rulings were in March but just popped up on Lexis last week.  We led in with a discussion of video games as a clever segue to the games some experts play. Really, no glimmer of recognition?  Well, the same case had summary judgment rulings that have now been “published,” so we are giving you a double dose.  See Newman v. McNeil Consumer Healthcare, No. 10 C 1541, 2013 U.S. Dist. LEXIS 113440 (N.D. Ill. Mar. 29, 2013).  As with the expert rulings, there is a mix of good and bad, but the bad gets stuck in our throat.  Dispensing with the lame medication jokes, on to the rulings, the good ones first.

Plaintiffs asserted a claim under the Illinois Consumer Fraud Act premised on “standby statements” from 2003 and 2005 concerning separate reports of SJS/TEN in children using defendants’ ibuprofen products.  This claim failed both because the statements were not deceptive—an obvious element of the claim—and because the defendants established the applicability of the Act’s regulatory compliance defense.  (The Act did not require that the plaintiff rely on the deceptive statement, only that the defendants intended that there be reliance, or there would have been another obvious basis where plaintiffs and their parents surely never saw the statements before using the product.)  As anyone who has ever participated in drafting any statements on adverse events knows, the line between saying something that will later be called an admission of causation and saying something that will later be called minimizing is a fine one.  The statements at issue described the particular cases as “allegedly associated” with the defendants’ product and noted that SJS and/or TEN, in general, “are associated” or “reported to be associated” with ibuprofen and other medications.  The FDA-approved label from 2009, when the plaintiffs used the product, included the warning that “[i]buprofen may cause a severe allergic reaction . . . .”  Under these circumstances, the statements were held consistent with the label and not “so misleading or deceptive in the context that federal law itself might not regard [it] as adequate.”  Id. at *19 (quoting Bober v. Glaxo Wellcome PLC, 246 F.ed 934, 941 (7th Cir. 2001)).  It was very sensible to not read “associated with” as deceptive simply because the label later said “may cause.”

The sensible approach continued in the evaluation of the evidence offered on the regulatory compliance defense—an unnecessary analysis given the lack of an otherwise actionable deceptive statement.  Without rehashing the discussion, which overlaps with the Daubert analysis at issue in yesterday’s post, the part that interested us was the use of statements from FDA in light of the inevitable allegations that defendants had underreported adverse events and generally kept FDA in the dark about the SJS risk of ibuprofen.  Defendants here were able to rely both on a 2006 denial of a citizen’s petition call for withdrawal of all OTC ibuprofen products—for once, not made by Public Citizen, at least openly—and deposition testimony of an FDA official.  The denial included the statement that “we have no evidence that there is additional undisclosed safety information that was withheld by ibuprofen manufacturers” and the FDA official did not suggest that defendants failed to perform any required analysis of adverse events.  Id. at **23-26.  With this back drop, the plaintiffs’ “slight, at best,” evidence of noncompliance could not be assumed to have “affected . . . FDA’s decision making.”  Id. at **26-27.  Placing the burden on plaintiffs to come forward with evidence that alleged noncompliance with regulatory requirements somehow invalidated FDA’s authorization of defendants’ statements was predictably fatal to plaintiff’s claim.

Continue Reading Recurring Intermittent Headache