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

On this date in 1896 the Dutch completed the harbor at IJmuiden.  (That capital J is not a mistake.  The I and J go together as a digraph, and they form a ligature that effectively makes up a single letter in the Dutch language.)  The IJmuiden harbor has an interesting history.  It connects Amsterdam to the North Sea via canals.  After the Germans invaded the Netherlands in 1940, the Dutch Royal family left the country from IJmuiden.  The Germans then used the IJmuiden harbor to house their torpedo boats and midget submarines.  After D-Day, the Allies bombed IJmuiden.  The American Air Force employed various weapons to penetrate the German concrete bunkers, including rocket-powered Disney bombs.  The bombs were named after war propaganda efforts by the Disney Studio.  Today IJmuiden harbor welcomes cruise ships.  It is a safe harbor.

(Yes, that is a rather long and pointless windup to get to our safe harbor case, but we are busily planning our Benelux Summer vacation, so you’ll have to excuse the travelogue/history.)

In the past we have had several opportunities to discuss state consumer protection laws containing “safe harbor” provisions that bar suits over conduct that was authorized, approved, or permitted by governmental agencies. Applying these safe harbor provisions, courts have dismissed consumer protection claims that attacked FDA-approved actions (usually labeling) after finding that the challenged conduct had the imprimatur of an agency.  One example was the DePriest case in the Arkansas Supreme Court.  The plaintiff in that case claimed that the defendant fraudulently marketed Nexium as better than older drugs that – allegedly – did essentially the same thing. The case was styled as an economic-loss-only class action.  The Arkansas Supreme Court threw the case out and we blogged about it here in 2009.


Continue Reading Consumer Food Fraud Claim Sinks in Arkansas Safe Harbor

While some of us are naturally jacked up—have you seen Bexis in short sleeves?—others turn to supplements to build up their beach bodies.  We are not talking about the injectables favored by 1970s East German Olympians or 1980s NFL draft flops.  And certainly not the supplements advertised on late night television as more targeted enhancers. 

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich.  It doesn’t fit, and the combination isn’t very appetizing.  FDA regulated manufacturers of prescription medical products aren’t snake-oil salesmen, payday lenders, reverse mortgage peddlers, or participants in some other “relatively common cash and credit transactions in which [consumers] engage on a regular basis.”  West Virginia ex rel. McGraw v. Bear, Stearns & Co., 618 S.E.2d 582, 587 (W. Va. 2005).  These statutes almost universally exempt government regulated activity, and instead of personal injuries consumer protection statutes typically allow recovery of non-tort damages such as monetary loss, attorney fees and multiple damages.

That’s one reason we were particularly pleased with the non-preemption part of the recent decision in Otis-Wisher v. Medtronic, Inc., ___ F. Appx. ___, 2015 WL 3557011 (2d Cir. June 9, 2015) (blogged about here), that dismissed the Vermont consumer protection act claims:

[T]he Vermont Consumer Protection Act . . . defines a “consumer” as a “person who purchases, leases, contracts for, or otherwise agrees to pay consideration for goods or services . . . for his or her use or benefit or the use or benefit of a member of his or her household.”  Plaintiff did not constitute a “consumer” under the statute because she did not, for her personal use, purchase [the product], which in any event is not available for consumer purchase, but rather was prescribed the medical device by her doctor. Though Vermont has apparently not addressed this issue in the specific context of medical devices, the District Court’s ruling here is consistent with that of courts in other jurisdictions interpreting similar consumer protection laws.

Id. at *2 (emphasis added).


Continue Reading No Prescription For Consumer Protection

On May 26, 2015, the Solicitor General’s office responded to the United States Supreme Court’s Oct. 14, 2014 invitation for the government’s views on the certiorari petition filed in Athena Cosmetics, Inc. v. Allergan, Inc., No. 13-1379.  The brief is on Westlaw at 2015 WL 2457643, and is also referenced (although not yet with

As anyone can tell from our class action scorecards (federal and state), plaintiffs have not done very well lately – lately being the last couple of decades – with class actions involving alleged injuries caused by prescription medical products.  Between the general predominance of individualized issues in personal injury cases and the specific focus on the actions of prescribing physicians in prescription-only product cases (thanks to the learned intermediary rule), plaintiffs have suffered defeat after defeat.  While things aren’t perfect, all in all successful class actions for purported prescription medical product injuries are pretty rare.

Each defeat drives the class action purveyors further towards the margins, and recently, in In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2015 WL 1736976 (E.D. Pa. April 16, 2015), one of the more marginal class action damages theories we’ve seen was swept away.

In Avandia, the would-be class representative did not claim to be injured in the slightest – either by the drug’s risks or by deprivation of the drug’s benefits.  As stated in the opinion, “Plaintiff received the drug she was prescribed, took the drug, and alleges neither that the drug failed to do its job (controlling Plaintiff’s blood sugar levels) nor that she was injured by taking the drug.”  Id. at *3.  The only damages that the plaintiff (and supposed class) sought were of the existential variety – some difference in subjective “worth” beyond what was reflected in the purchase price of the drug, purchase price being how value is necessarily determined in a free-market economy.  The complaint itself, doubtless to suppress the numerous individualized issues bubbling below the surface, was appallingly generalized and superficial.  The court observed:

Plaintiff does not allege when or for how long she took Avandia or how much she paid for it; nor does she identify the prescribing physician or allege any facts regarding her medical treatment.  Plaintiff also does not allege that Avandia was ineffective in treating her Type II diabetes, whether she took or would have taken another drug instead of Avandia, or the cost of such other drugs.  Plaintiff seeks damages “equal to the difference between the actual value of Avandia and the value of Avandia had it been as represented by Defendant.”

Id. at *1 (quoting complaint).


Continue Reading Illusory Economic Loss Theory Held “Absurd” – Class Action Dismissed

Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we  usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.

The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs.  We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not  the government, had the drugs in question.  The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway.  Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions).  We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.


Continue Reading Still No Duty To Supply Drugs – In 22 States

We have had some time now to ruminate over the South Carolina Supreme Court’s opinion in State of South Carolina ex rel. Wilson v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 2012-206987, 2015 WL 775094 (S.C. Feb. 25, 2014).  In Wilson, the state attorney general brought an enforcement action against the manufacturer of the atypical antipsychotic Risperdal under the state’s Unfair Trade Practices Act (having the dysphonius acronym “SCUTPA” in the opinion) and recovered $327 million in civil penalties. Although the Supreme Court reduced the award to $136 million, it mainly affirmed a verdict that, in our view, has multiple problems.  What problems?  Well, how about a nine-figure civil penalty for “deceptive” conduct when the state neither alleged nor proved that a single person was deceived or that the conduct had any adverse impact on anyone?  We call that a problem, but we’ll get back to that particular point in a moment.

Those who read our 2014 Ten Best column and those who dialed into our teleseminar in January on those cases know a little about Risperdal and the various states’ lawsuits against the drug’s manufacturer.  What happened was that the FDA asked all manufacturers of atypical antipsychotics to review data on diabetes, which resulted in a new warning on diabetes being added to the labels.  The FDA also required a Dear Healthcare Provider Letter, which the manufacturer of Risperdal sent, but the letter included information that was technically off label.

That resulted in an FDA warning letter in April 2004 stating that the DHCP Letter was “false or misleading” in violation of the FDCA, which in turn resulted in the manufacturer sending a corrective DHCP Letter.  Wilson, 2015 WL 775094, at **5-6.  That seems to be when various state attorneys general and their contingent-fee lawyers took interest.  Two of our Ten Best cases of 2014 were state false claims act cases arising out of these events where the states of Louisiana and Arkansas recovered very large judgments against this manufacturer.  Both verdicts were reversed on appeal, which was good news.


Continue Reading An Atypical View of Causation and Harm from South Carolina

Our occasional claims of dyspepsia may be attributed to various things.  Professional witnesses offering personal opinions from the stand, juries deciding based on emotion and bias, plaintiff lawyers being sleazy, and judges writing decisions driven by a predetermined result or just bad reasoning come to mind. Sometimes, we recognize that our discomfort stems, at least in part, from the subject matter of a case extending past the reasonable, yet wide and knowingly self-inflated, bounds of our expertise.  Among our hundreds of posts, more than a handful touch on Drug & Device Law in that they (1) involve cases with our clients’ products far from product liability or (2) involve issues we see in our cases being presented in very different types of cases.  While we may throw in some caveats about how we are treading beyond our usual bailiwick, we still offer our views and perhaps even a somewhat blind rant.  Here we are again—personally, this blogger has skipped the last three weeks for trial preparation and denouement—with a decision in a case that is far afield in some respects, but just does not feel right in about every respect.

The decision of the First Circuit in In re Nexium Antitrust Litig., Nos. 14-1521, 14-1522, 2015 U.S. App. LEXIS 968 (1st Cir. Jan. 21, 2015), affirming a class certification order from the District of Massachusetts is not too surprising if you just consider the courts involved and the name of a drug in the case caption. If you add that, broadly categorized, this is a third party payor case, then our view that the decision does not make much sense is even less surprising.  The allegation in the case, though, is something we find fairly novel and decidedly weird.  Plaintiffs are “union health and welfare funds that reimburse plan members for prescription drugs”—that is, a type of third party payor—and they claimed that the defendant branded manufacturer of a particular heartburn drug and three putative manufacturers of a generic form of the drug conspired to overcharge for the branded drug when they entered into settlements over patent infringement suits that paid the putative generic manufacturers to not try to get their ANDA approvals and sell their own versions for about six more years.  Are you with us so far?  Not being able to sue under federal antitrust laws because the Supreme Court says indirect purchasers are too remote to have a cognizable injury, the plaintiffs sued under state antitrust laws—adopted by half the union specifically to provide a claim not available under federal law—and state consumer protection laws.  They sued in one federal court (the E.D. Pa.) and the case was moved to another by the JPML. They sought a class on behalf of everybody in the U.S. or its territories who paid (or will have paid) any money for the drug, including generic versions not yet on the market, for their own use or use by anybody else.  With our caveat about the limits of our expertise, this lead in makes us start wondering about subject matter jurisdiction, personal jurisdiction post-Bauman (especially with the foreign defendants), how third party payors could be class reps for patients who bought their own drugs or for people who bought drugs for their relative, how a court-approved consent judgment could be considered anti-competitive behavior without running afoul of Noerr-Pennington doctrine,  and how there was not some preemption issue in basing state law liability on an assumption that FDA would have approved one to three ANDAs even if there were no patent issues.  Then we took a deep breath and realized that the Nexium decision did
not address any of that stuff.  It did note, however, that the defendants had already won a jury verdict at trial this past December, but “[t]his, of course, does not moot the case here given the possibility of further proceedings.”  Then we went back to bellyaching about what else was wrong with the basic premise of this case.  Then we had a drink.  And we don’t mean an antacid.


Continue Reading Indigestion Inducing Treatment of Class Certification Requirements

It is the time of year for reflection and resolutions. We look back on the ups and downs of the year that is about to end and look forward to the New Year with hope, promises and predictions.  As for 2015 here at the DDL Blog – we hope we will continue to be helpful and informative to our readers, we promise that Bexis will find at least one decision a quarter worthy of a full-blown tirade, and we predict that McConnell will keep us up-to-date on both legal trends and what’s hot on TV and at the movies.

As for 2014, Bexis is posting his annual Best Of and Worst Of lists.  Keeping with that theme, we decided to post about a case that has some of both, the good and the bad.  The case is Brown v. Johnson & Johnson, 2014 U.S. Dist. LEXIS 173800 (E.D. Pa. Dec. 9, 2014) and it involves the over-the-counter drug Children’s Motrin.  Wanting to end on a high note, we’ll dispense with the low points of the decision first.

First up, the preemption rulings.  The court held that plaintiff’s failure to warn claim was not preempted because the defendant had not shown that it could not have used the CBE process to change the warning label.  Establishing warning preemption in a drug case is an “exacting burden” for defendants requiring clear and convincing evidence that the FDA would have rejected the warning proposed by plaintiff.  Id. at *2-3.  The court applied the same “exacting burden” to defendant’s design-related preemption defense, finding a lack of evidence that the FDA would have rejected a proposed design change as well.  Id. at *6.


Continue Reading Celebrating the Highs and Lows