Presumption Against Preemption

Last week appears to have been a bit of a slow week in the drug and device litigation arena. It was after all a short work week. It was back to school week (at least in the North East), which while bringing delight to parents everywhere also brings the chaos of last minute school supply shopping, discovering sneakers no longer fit, and the start of chauffeur season where parents essentially become Uber drivers between school, lessons, practices, and games. And we know our friends in the South had a few other things on their mind as they prepared for Irma.

So, that leads us to look beyond our normal comfort zone to see what else might be going on. Sure, enough we found a discussion of Buckman preemption in an automobile emissions case.

The case comes out of the In re: Volkswagen “Clean Diesel” Marketing, Sales Practices, and Products Liability Litigation, MDL 3354 and specifically the case of Wyoming v. Volkswagen Group of America, Inc., 2017 U.S. Dist. LEXIS 142586 (N.D. Cal. Aug. 31, 2017). Volkswagen’s “clean diesel” issues have been widely publicized and were the subject of significant criminal penalties and civil settlements having to do with Volkswagen’s installation in its diesel cars of software to defeat emissions testing which allowed the vehicles to acquire the necessary new-vehicle certifications from the EPA. Id. at *805-806. Under EPA regulations, the installation of such a “defeat device” is prohibited and the EPA has authority to bring a civil action for violation of that regulation. 42 U.S.C. §§7522(a)(3)(B); 7524(b). Wyoming, among other states, sued Volkswagen alleging the defendant violated Wyoming’s State Implementation Plan (“SIP”). Trying not to delve too deeply into the law, essentially the Clean Air Act requires each state to develop a SIP to enforce the EPA’s national air quality standards. The individual states are supposed to focus on stationary sources (factories, plants) and are limited in how they can regulate motor vehicles. Id. at *810. Considering how freely and frequently (daily) motor vehicles cross state lines, we understand why individual state plans regulating car emissions would be almost impossible to enforce.

So, the Clean Air Act allows states to regulate the use of “registered or licensed motor vehicles” as opposed to new vehicles Id. at *823, citing 42 U.S.C §7543(d). For instance, states can require testing after sale to ensure cars continue to meet emissions standards. Along those lines, Wyoming’s SIP includes provisions that say you cannot remove or render ineffective any air pollution control device and you cannot use a device that conceals an emission. Id. at *810-811. It is these two provisions which Wyoming argues Volkswagen is liable for violating.

The Clean Air Act, however, also contains an express preemption clause:

No State or any political subdivision thereof shall adopt or attempt to enforce any standard relating to the control of emissions from new motor vehicles or new motor vehicle engines subject to this part. . . .

42 U.S.C. § 7543(a). “States accordingly may not adopt their own rules prohibiting defeat devices in new vehicles, nor may they attempt to enforce EPA’s rule barring defeat devices in new vehicles.” Id. at *829. If you interpret Wyoming’s SIPs the way Wyoming is asking, they would run afoul of the express preemption clause. The SIPs are fine if you are talking about a mechanic tampering with a device so a car passes emissions inspection. That’s something for the state to regulate.

The court found additional support for its preemption analysis in Buckman. Wyoming is essentially bringing a fraud-on-the-EPA claim. Like the authority vested to the FDA for drugs and medical devices, Congress has given the EPA the same authority to both regulate and enforce new-vehicle emissions standards. Id. at *832-834.

If, despite this authority, States could bring actions against vehicle manufacturers based on deceit of EPA during new-vehicle certification, manufacturers would be forced to comply with EPA regulations “in the shadow of 50 State” regimes, which would “dramatically increase the burdens” manufactures would face in bringing new vehicles to market.

Id. at *833-34 (quoting Buckman).

Therefore, the court dismissed Wyoming’s claims as preempted and perhaps foreshadowed a similar demise for claims brought by other states. And while that is a great result, there is one glitch in the decision. This court apparently missed our post on the demise of the presumption against preemption in express preemption cases. As it begins its preemption analysis, the court states that part of its “interpretative framework” would include the presumption against preemption. Id. at *819. Fortunately, the presumption plays no further role in the court’s analysis and ultimate conclusion – because it shouldn’t it. The court even quotes Medtronic v. Lohr, that the presumption applies “unless [preemption] was the clear and manifest purpose of Congress.” Id. at *818 (quoting Lohr 518 U.S. 481, 485 (2006)). An express preemption clause like the one quoted above is fairly clear and manifest. And, if that wasn’t enough, the Supreme Court has been even more explicit:

[B]ecause the statute “contains an express pre-emption clause,” we do not invoke any presumption against pre-emption but instead “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016). Done and done. So, while we laud the conclusion, we also use the decision to remind our readers that the presumption against preemption has been definitely knocked out of express preemption cases.

 

We’ve always been bothered by the presumption against preemption – so much that this blog’s first major substantive post was on that subject.  Even before that, back in the Bone Screw days, we remember the presumption against preemption accompanying the death of express preemption for 510(k) medical devices in Lohr.  In Lohr, the presumption was used as a narrowing principle of statutory construction: “[W]e use[] a presumption against the pre-emption of state police power regulations to support a narrow interpretation of such an express command.”  Id. at 485.  Then along came Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), which (as we pointed out at the time) upheld preemption of pre-market approved medical devices under the same statutory provision with nary a peep about any preemption-busting presumption.  Nonetheless, even after Riegel, some lousy circuit court decisions still invoked the presumption as a way of poking holes in PMA preemption, most notoriously the en banc Ninth Circuit in Stengel v. Medtronic Inc., 704 F.3d 1224, 1227-28 (9th Cir. 2013), which fawned over the presumption at some length before deciding that a duty to provide information to a governmental agency wasn’t any different than a bog standard product liability duty to warn.

The presumption also came up in the context of the Vaccine Act, where one court (discussed here) sought to nullify statutory preemption by latching onto a statement in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (a non-FDCA case), about there being “a duty to accept the reading [of a statute] that disfavors pre-emption,” even where there are other equally “plausible” interpretations. Id. at 449.  That view was shot down by the Supreme Court in Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), which interpreted the Vaccine Act’s preemption clause in a pro-preemption direction with nary a mention of the erstwhile adverse presumption – something else we mentioned at the time.

Then along came PLIVA v. Mensing, 564 U.S. 604 (2011), where four justices found, if anything, a presumption in favor of presumption, id. at 621-23 (viewing the Supremacy Clause as a constitutional “non obstante” provision), four justices disagreed, and one didn’t take a position.  Mensing, of course, was an implied preemption case.

For these reasons, we speculated a little over a year ago whether the presumption against preemption might be dead.  Then a little later, we thought we might be wrong.

Turns out we’re half right.

Continue Reading The Demise of the Presumption Against Preemption in Express Preemption Cases

Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) – which is to expose them to still more garbage class actions over labeling that complies with federal government standards.  As we discussed here, in the Salmon cases the court had to work reasonably hard to come up with an (uncodified) food-related exception to the general ban on private enforcement of the Food, Drug & Cosmetic Act (“FDCA”).

The court had an easier job of it in Quesada because the federal statute that conferred on the Department of Agriculture the power to certify food as “organic” didn’t have a private enforcement provision similar to the FDCA’s 21 U.S.C. §337(a).  Rather, “With respect to enforcement, . . . [t]he act contemplates a cooperative state-federal enforcement regime.”  361 P.3d at 871 (citations omitted).  See also Id. at 875 (with respect to act’s section on “sanctions for misuse of the organic label,” “nothing in [it] suggests these federal remedies are intended to displace whatever state law remedies might exist”).

So why are we telling you this?  We’re not the food blog, after all.  Unlike the Salmon decision, this latest addition to food class action mania in California doesn’t even involve the FDCA.

Continue Reading California Supreme Court – Presumption Against Preemption Still Around

Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined.  Much like the origins of the Jedi or the major end-of-year holidays as we know them, one would expect a clearer published record of how this came to be.  There can be a tendency to read back from recent experience and imbue our past selves with more knowledge or foresight that we actually had.  For preemption of design defect claims against branded prescription drug manufacturers, we know we have been arguing for it for years and we are not quite sure why it took so long for a Circuit Court to adopt it.  As we noted a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did find preemption, and did it pretty definitively.  So definitively that it took our spot as top decision of 2015.  Along the way, the court declined to follow a prior decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), which itself reversed decisions of the trial court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting summary judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying motion to alter judgment), each of which included the holding that pre-approval design defect and negligence claims were preempted.  It is with the Longs/Wimbush decisions where our story starts, subject to some back story and with a healthy dose of links to past posts.

We first note, however, that it has long been our view, expressed in many posts and elsewhere, that design defect does not make much sense as a theory of liability for a prescription drug.  In most cases, what the plaintiff alleges made the drug excessively risky and thus defectively designed cannot possibly be changed without making it a different drug.  One of the principles of pharmacology is that changes to the chemical compound will typically affect both the desired and undesired effects in the body–or as the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.”  133 S. Ct. 2466, 2475.  Rarely, a true change to the “design” of the active compound can be identified—maybe chop off this ethyl group or change it from a racemic mixture to a stereoisomer—that will plausibly reduce the pertinent risk, while maintaining benefits and avoiding new risks.  Even where that kind of proposed design change exists, the change would make the drug a different product, not a better version of the same product, which is what design defect is supposed to be about.  There may be some cases where a plaintiff claims that a different balance of a combined drug’s ingredients, or an
inactive ingredient, or the delivery system should be changed to reduce the risk without making it a different drug. Even those cases, though, seem better suited to warnings-based claims.

Continue Reading The Saga of Preempting Prescription Drug Design Defect Claims

Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida.  True, Justified was set in Kentucky.  But Marshall Givens was forced to leave the Sunshine State after shooting a suspect (“Let’s just keep it simple: he pulled first,  I shot him”), and the big criminal organization he often contended with hailed from Detroit.  Leonard, also known as the Dickens of Detroit, was a native of Michigan and later spent much time in Florida.  Those two locations furnish a nice contrast between city and swamp, both settings being utterly sweaty and corrupt.

There is nothing especially sweaty about what we do, and we’d like to think that corruption is far, far away, but if you delve into our litigation docket, you are likely to encounter a tug of war between Michigan and Pennsylvania.  We live in Pennsylvania.  Our courts and laws seem inordinately fond of drug and device law plaintiffs.  By contrast, Michigan has just about the best, most pro-defense laws on the books, and, consequently, Michigan plaintiffs look to hightail it out of there and file their cases in a more hospitable jurisdiction – like, say, ours.

Recently in the Philly mass tort Risperdal litigation, a local judge did the right thing and told Michigan plaintiffs that they were stuck with Michigan law.  In Re Risperdal Litigation, 2015 Phila. Ct. Com. Pl. LEXIS 254 (Phila. CCP October 1, 2015).  The 13 plaintiffs were Michigan residents who claimed that they developed gynecomastia after taking Risperdal during adolescence.  The defendants filed summary judgment motions arguing that Michigan’s Products Liability Act applies and affords the defendants immunity on the plaintiffs’ claim for 1) negligence, 2) negligent design defect, 3) fraud, 4) strict liability – failure to warn, 5) strict liability – design defect, 6) breach of express warranty, 7) breach of implied warranty, 8) conspiracy, and 9) medical expense incurred by parents.  The plaintiffs disagreed.  They needed Pennsylvania law to apply, otherwise they would lose.

They lost.

Continue Reading Philly Court Applies Michigan Law to Dismiss Risperdal Cases

Anybody who watched the Mayweather-Pacquiao fight knows that a long fight does not necessarily make for an exciting fight. Thirty-six minutes of “action” can actually contain very little action. The exceedingly long decision of the court in Grocery Manufacturers Assoc. v. Sorrell, No. 5:14-cv-117, 2015 U.S. Dist. LEXIS 56147 (D. Vt. Apr. 27, 2015), has little to keep our DDL-centric attention—its discussion of preemption based on various federal statutes, including the FDCA.  As the court forcefully rejected most preemption arguments raised by trade groups whose members were likely to be affected by Vermont’s labeling rules for foods derived in whole or in part from genetic engineering, we are reminded of another dynamic from the “Fight of the Century.”  Watching live, with the volume up, a viewer might have been swayed by the cheering of the decidedly pro-Pacquiao crowd into thinking Pacquiao was doing damage during many of the too-infrequent exchanges of punches.  However, almost invariably, the slow-motion replay between rounds showed Pacquiao’s blows had been deflected and followed by a Mayweather punch to the face, the latter almost too quick to see in real time.  Similarly—or at least as similarly as pugilistic analogy allows—the court’s analysis of preemption relied on borrowing concepts from one type of preemption and applying them to another without saying what it was doing.

As our resident state historian cum travel brochure maker (and boxing aficionado) has noted here and here, Vermont has been known to do its own thing. That has included enacting peculiar statutes that unconstitutionally impinge on national commerce.  Based upon its judgment that the various federal statutes and regulations—and the pendency of federal legislation—did not do enough to inform consumers of the existence of ingredients created through some degree of genetic engineering in products they might purchase, the Vermont legislature enacted Act 120.  It contained two provisions challenged in the GMA case, one requiring packaging or site-of-sale displays disclosing the presence of ingredients derived from genetic engineering in products for sale and one prohibiting labeling or advertising describing the product as “natural” in one way or another.  (We will skip the discussion of how much genetic engineering counts, given that humans have been eating “genetically engineered” food ever since our ancestors started selectively mating captured aurochs or zebu and have known that this was a manipulation of genetics at least since Gregor Mendel started playing with peas in his abbey.)  The legislature could not say that foods with one or more genetically engineered ingredients were less safe than those without, but cared that polls showed Vermonters wanted to know about the presence of such ingredients so they can make “informed decisions” and not be “confus[ed] and dece[ived]” by claims of “natural” products.  Before Act 120 even took effect, a multi-faceted constitutional challenge was brought.  The decision we are discussing results from the Vermont AG’s motion to dismiss and the plaintiff’s motion for preliminary injunction.  If you want to read about the Commerce Clause or First Amendment issues with Act 120, knock yourself out, but we will not discuss them here.

Continue Reading Going The Distance To Limit Preemption

We’ve got the expression “the dog that didn’t bark” stuck in our heads today, and it’s not just from that phrase being used in the recent Caplinger decision. See Caplinger v. Medtronic, Inc., ___ F.3d ___, 2015 WL 1786742, at *9 (10th Cir. April 21, 2015) (blogged about here). No, it’s also our reaction to another preemption decision handed down almost simultaneously with Caplinger – by the Supreme Court – in Oneok, Inc. v. Learjet, Inc., 2015 WL 1780926 (U.S. April 21, 2015).  Both Oneok and the majority’s opinion in Caplinger share something in common beyond being decided on the same day and being about preemption.  Neither so much as breathes a word about the embattled “presumption against preemption.”

That the Caplinger majority doesn’t mention any presumption (or assumption, or whatever) against preemption isn’t really surprising, since it affirmed preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in which the Supreme Court majority did likewise.  It is surprising that Oneok didn’t rely, or even reference, such a presumption.  FirstOneok found no preemption, and we’ve noted elsewhere, the presumption against preemption is one of those result-oriented things that tends to pop up when consistent with a no-preemption result and vanish where preemption is found.  SecondOneok is a field preemption case (one reason why nothing else in it is terribly pertinent), and field preemption is where the presumption against preemption originated.  As we said in one of our very first posts:

The presumption asserted by the Lohr plurality originated in preemption discussions involving neither express nor conflict preemption – but rather “field” preemption.  Thus, in Rice v. Santa Fe Elevator Corp., 331 U.S. 230 (1947), the Court noted, “the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id. at 230 (citations omitted). . . .  Rice involved the most sweeping form of preemption – field, not conflict preemption.

The Rice assumption became a presumption in Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715-18 (1985), and Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977) (cases also cited in Lohr).  Both of these cases rejected field preemption before turning to additional preemption arguments raising actual conflicts with federal regulation.  Both courts invoked a “presumption” against preemption solely in their discussions of field preemption.

Continue Reading Is The Presumption Against Preemption Dead?

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