Presumption Against Preemption

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

Anybody who has ever had the pleasure of listening (as we have) to Dean Erwin Chemerinsky  expound upon the Supreme Court’s constitutional decisions knows that the man is drop-dead brilliant.  If you haven’t caught one of his lectures, you should – and can, here and here.  He can go on for an hour, without notes, and rattle off not just the important holdings of dozens of Supreme Court decisions, but even how each justice voted on each case.

Dean Chemerinsky has undoubtedly forgotten more constitutional law than we know – and he doesn’t forget much.  Thus it is with some trepidation that we find ourselves in the position of offering a rejoinder to his recent piece in the online ABA Journal on preemption and prescription drugs. But in this limited area, preemption and prescription medical products, we’ve done a great deal of thinking and writing about both prescription drugs and medical devices.  So we’ve decided to take the plunge.

We don’t have much quarrel with Dean Chemerinsky’s initial observation that the existing regime for preemption and prescription drug product liability litigation, fashioned by the trilogy of Wyeth v. Levine, 555 U.S. 555 (2009), PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), in his words, “makes no sense”:
Continue Reading Preemption – A Counter To Dean Chemerinsky’s Proposal

It seems that there’s a reason to blog about Pom Wonderful or a similar case almost weekly, and the cases always seem to come from California.  So now we have Brazil v. Dole Food Company, 2013 WL 1209955 (C.D. Cal. Mar. 25, 2013).  This one is a class action (Pom Wonderful was a business dispute) in which the plaintiff claims that certain Dole food products were improperly marked as “natural,” “fresh,” “sugar free,” “low calorie,” or the like.  Plaintiff’s claims are the usual suspects: violations of California’s Unfair Competition Law (“UCL”), False Advertising Law (“FAL”) and Consumer Legal Remedies Act (“CLRA”), violations of the Song-Beverly Consumer Warranty Act and Magnuson-Moss Warranty Act, and an unjust enrichment claim.

Now, the outcome was generally good.  The court dismissed all of plaintiff’s claims.  But some bad came with it.  The dismissals of plaintiff’s UCL, FAL and CLRA claims were without prejudice because those particular dismissals were based on plaintiff’s failure to satisfy FRCP 9(b)’s heightened pleading standards for fraud.  The court rejected the Defendant’s argument that those claims should be dismissed “with prejudice” as preempted by the food labeling portions of the FDCA.  So the plaintiff has the opportunity to replead them.

As background, you may recall that the 9th Circuit in Pom Wonderful, upheld the dismissal of Lanham Act claims about food labeling because they were barred by the FDCA, which can be enforced only by the United States, not private plaintiffs.  And last week on remand, the Pom Wonderful district court dismissed plaintiff’s remaining state-law claims as preempted by the FDCA.  So why wouldn’t the Brazil court dismiss plaintiff’s food claims as preempted?


Continue Reading More Food Litigation and, Yet Again, More Pom Wonderful

           We read
the decision in Tigert v. Ranbaxy Pharms.,
No. 12-00154 (RBK/JS), 2012 U.S. Dist. LEXIS 178475 (D.N.J. Dec. 18, 2012),
with interest.  It involved a recurring
question that the Supreme Court failed to address in Warner-Lambert Co. v. Kent, 552 U.S. 440 (2007)—whether state
statutory provisions that require a plaintiff to

Does Buckman v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), apply any time that a plaintiff raises a fraud on the FDA allegation in litigation, or is it limited to causes of action denominated “fraud on the FDA?  Most courts have agreed with the Sixth Circuit that Buckman applies across the board.  See , 385 F.3d 961 (6th Cir. 2004).  A persistent minority, however, has limited Buckman to complete “fraud on the FDA” causes of action.  See Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).  The Supreme Court attempted, but failed, to close the split in Desiano, but failed – splitting 4-4.  See Warner Lambert LLC v. Kent, 552 U.S. 440 (2008). Garcia v. Wyeth-Ayerst Laboratories

Both Garcia and Desiano involved the “fraud on the FDA” exception to a Michigan tort reform statute that imposes a presumption of adequacy on warnings that are FDA approved – that is, just about every warning.  The Michigan statute was essentially dispositive.

Then Texas passed a similar presumption statute that is almost as dispositive in the ordinary case as Michigan’s.  It was only a matter of time before the Fifth Circuit would be called upon to decide the same question as in Garcia/Desiano.

Also in the mix is the Supreme Court’s later, extremely anti-preemption, decision in Wyeth v. Levine, 555 U.S 555 (2008).


Continue Reading Fifth Circuit Breaks Buckman Tie

A friend of ours, we’ll call him “Anonymous,” let us know about the recent decision in Forman v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2011 WL 2559386 (E.D.N.Y. June 27, 2011).  We reviewed it, and were somewhat taken aback that – after the court in Desiano v. Warner–Lambert & Co., 467 F.3d 85 (2d Cir. 2007), presumed to know more about Michigan law than either the Michigan courts (Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003)) or the Sixth Circuit (Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004)), with jurisdiction over Michigan – yet another court out of New York now presumes to know New Jersey law better than the New Jersey courts (McDarby v. Merck & Co., 949 A.2d 223 (N.J. App. Div.2008)), and the New Jersey federal courts, which have followed McDarbySee Stanger v. APP Pharmaceuticals, LLC, 2010 WL 4941451, at *4 (D.N.J. Nov. 30, 2010); Baker v. APP Pharmaceuticals, LLC, 2010 WL 4941454, at *4 (D.N.J. Nov. 30, 2010); Haggerty v. Novartis Pharmaceuticals Corp., 2009 WL 5064779, at *4 n.4 (D.N.J. Dec. 15, 2009).

We made that point to our friend.

His response?

“Hey, its New York!  You’re looking for humility?”

We wouldn’t dream of going that far.  After all, we know more than a few Yankees fans.

We’d just like to see a little comity every now and then.

That would preferable to the current, absurd situation where, in a prescription drug case in Michigan, or in a punitive damages case involving drugs in New Jersey, the plaintiffs lose under those states’ application of the fraud-on-the-FDA preemption rule of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), to their own law.  But if plaintiffs can somehow wheedle their way into court in New York, then the same claims survive.

We made this last point in our initial discussion of Desiano way back in 2006, where we urged federal courts to “remember federalism” and not construe state causes of action differently from the courts of those states.  With New York courts continuing to boldly go where no courts have gone before (or since), and forum-shopping plaintiffs following them, we think it’s time to review this issue.

First, Buckman (with the caveat that Bexis’ role in that case gives us more than the usual defense interest in its correct application).


Continue Reading No Stand Up Comity In New York

Two recent cases, one good and the other not, have us thinking about the presumption against preemption in the context of “parallel” claims – that would be medical device preemption – and allegations of fraud on the FDA, which could be either.  We think it would be a good idea for defense counsel to review

It’s Labor Day, the unofficial end to what has been a long, hot Summer. (Shakespeare wrote that “thy eternal summer shall not fade,” but this sweltering season has us saying, ‘please, please, fade away.’) We’re getting ready for the family BBQ and suspect that, as is often the case, the appetizers (salmon pinwheels, buffalo mozzarella) will outshine the more pedestrian main course.

The same thing happened in the case of Yocham v. Novartis Pharmaceuticals Corp., 2010 U.S. Dist. LEXIS 90005 (D. N.J. August 31, 2010). We like the minor rulings. But the main ruling on preemption makes us gag.

The plaintiff was a Texas resident who alleged that she developed Stevens-Johnson Syndrome from Lamisil. Her complaint asserted claims of negligence, strict liability, express and implied warranty, misrepresentation, unjust enrichment, and violations of the New Jersey Product Liability Act and the New Jersey Consumer Fraud Act.

Let’s start with the good bits. Plaintiff sought application of the law of New Jersey, where Defendant was located. Plaintiff lived in Texas, took the Lamisil in Texas, and sustained the injury in Texas. But Texas “does not permit design defect claims for prescription drugs with otherwise adequate warnings.” Yocham, 2010 U.S. Dist. LEXIS 90005 at * 13. So it’s no surprise that the Texas plaintiff shunned Texas law. Following the “most significant relationship” test, the Court didn’t have much difficulty choosing Texas law. Plaintiff put up a struggle, contending that the location of the injury was “fortuitous.” Id. at * 13-14. That’s sort of silly. It reminds us of people who misuse certain words, “fortuitous” often one of them. It’s almost as irritating as the misplaced “hopefully,” lodging “only” next to the wrong adjective or verb, or writing “alot” as one word.

One’s choice of residence is not “fortuitous.” The late, great comedian Bob Schimmel said it would be weird to show up at somebody’s house and claim it was “fortuitous” to find them there. The Restatement’s “example of fortuitous place of injury involves the purchase of an airline ticket to fly from one state to another part, which route happens to overfly a second state, that state has no relationship to the parties, and the only relationship to the occurrence is mere chance.” Id. at * 14. Bottom line: “It was not fortuitous that Plaintiff was injured in Texas, her state of residence.” Id.

We also like the way the Court dealt with the express warranty claim. The Court pushed the eject button because Plaintiff “has not adduced evidence of reliance.” Id. at * 39. Rather, Plaintiff “relied exclusively on the advice of her physician in deciding to use Lamisil.” Id. at * 40.

Now for the main course, which gave us indigestion. Under Texas law, there is a statutory defense to failure-to-warn claims aimed at FDA-approved warnings. The only exception to the defense requires a showing that the defendant misled the FDA. Is that exception preempted by federal law? Do you really need to ask?

In Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), the Supreme Court “held that a state cause of action for injuries caused by misrepresentations made to the FDA was impliedly preempted by the [FDCA].” Yocham, 2010 U.S. Dist. LEXIS 90005 at * 22. Since Buckman was decided, the battleground has been state statutes, like that in Texas, providing a defense that is called off only if there was fraud on the FDA. That battle has largely turned out to be a debate between the pro-preemption position set forth by the Sixth Circuit in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), and the anti-preemption position set forth by the Second Circuit in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008). We’ve written at length on this debate before and before and before that, so we won’t repeat ourselves here (at least not too much). Let’s leave it at this: the Garcia line of cases (which, thankfully, seems to be winning) is a straightforward application of Buckman, while the Desiano line tortures logic and policy.


Continue Reading Barbecued Buckman

We promised you that we would be “mining the depths” of Third Circuit’s opinion in Colacicco v. Apotex Inc., 521 F.3d 253, 2008 WL 927848 (3d Cir. Apr. 8, 2008), affirming implied prescription drug preemption. That, of course, assumes that our doing so is a good thing. But we have to believe that most