At times, we have given a glimpse into the sausage making that goes into our production of posts on recent interesting cases and developments.  Part of the process involves standing searches for “published” (including by the electronic services) decisions from trial courts and appellate courts.  Sometimes, the trial court decisions are unpublished but interesting, and the appellate decisions are published but not too interesting.  When we saw the Sixth Circuit decision in Agee v. Alphatec Spine, Inc., — Fed. Appx. –, 2018 WL 1020078 (6th Cir. Feb. 22, 2018), on one of our standing searches, it was not interesting enough to merit a post.  A short per curiam decision noted how awful plaintiffs’ complaint was and how they had waived their position on preemption by mixing up express preemption with the implied preemption raised by the defendant’s motion to dismiss.  We were feeling sleuthy, however, so we tracked down the district court’s decision from a year ago.  It has a nice discussion of Buckman, and will now be published, so we are going to discuss it.

Agee v. Alphatec Spine, Inc., No. 1:15-cv-750, 2017 WL 5706002 (S.D. Ohio. Mar. 27, 2017), reads like the sort of case brought when the plaintiffs are looking for someone on whom to pin liability in the absence of a claim against the most logical defendant.  The plaintiffs claimed that a surgeon used defendant’s product in connect with unnecessary spinal surgeries without proper informed consent, but the surgeon fled the country with criminal charges pending.  So, the plaintiffs asserted various product liability claims against the manufacturers of the product, PureGen.  Usually, we would state clearly what type of product is at issue, but neither decision really says, other than to say the defendants are medical device companies and the product was used to stimulate bone growth.  We did a little looking and saw that PureGen is an “osteoprogenitor cell allograft” derived from donated adult stem cells.  We also saw that there was some history with FDA over whether this was a biologic, requiring approval of a Biologics License Application, or a device that might go through the 510(k) pathway.  In any event, plaintiffs seemed to claim defendants should be liable for their injuries—it was unclear that there were any physical injuries—solely because PureGen “had never been approved by FDA for use in the spine.”  Defendants moved to dismiss.

We will skip over the TwIqbal part of this—although there are nice statements and the interesting fact that some of the plaintiffs were suing in the same court with contrary allegations about another product—and the some of the details of Ohio law to get to the Buckman part.  After reiterating the Buckman standard and the cases explaining that a court is to look at the asserted claims to see if a violation of the FDCA is a critical element, the court did just that, providing something of a roadmap on what is preempted under Buckman.  The claim for defective manufacturing alleged that the failure to obtain FDA approval made the product produce injury.  (That is not close to a manufacturing defect claim under Ohio law, which has codified the claim under ORC 2307.74.)  The design defect claim was identical (and similarly off-target from ORC 2307.75).  The warning defect claim was also predicated on lack of approval of the product, but not even that the warning misrepresented the regulatory status.  The misrepresentation claim was predicated on a representation to plaintiffs and their doctors that the product was approved or concealing from them that it was not.  A similar claim for nonconformance with representation (under ORC 2307.77) was slightly less clear, in that it referenced “representations made by defendants concerning the product and/or with applicable federal requirements.”

The court’s analysis of these claims was clear and quotable:

Each of the above-quoted claims is clearly dependent upon the FDCA to a degree that the claims would not exist but for the statute. It may or may not be the case that the promotion and distribution of PureGen for use in the surgeries references in the complaint was in violation of the FDCA and relevant FDA regulations.  However, if that is the case, it is the sole responsibility and privilege of the federal government, and not private plaintiffs, to bring a suit to enforce those violations.

Well-reasoned. And dispositive.  And now affirmed on appeal.

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 talk a lot on this blog about Buckman preemption. That isn’t just out of pride regarding Bexis’s role in the bone screw litigation that led up to the Buckman decision. The principle in Buckman is important. What happened in Buckman? Here is a nice summary: “In Buckman, the plaintiffs brought state law claims against a consultant for injuries caused by orthopedic bone screws alleging that the defendant made fraudulent representations to the Food and Drug Administration (‘FDA’) in the course of obtaining approval to market the screws. 531 U.S. at 343. The Supreme Court found that federal law preempted state-law tort claims for fraud on the FDA.” Meijer, Inc. v. Ranbaxy, Inc., 2017 U.S. Dist. LEXIS 45527 (D. Mass. March 28, 2017).


The Buckman principle is crucial for our drug and device clients because most lawsuits against them challenge products and/or communications that were approved or cleared by the FDA. If promises were made, they were made in both directions. FDA action or inaction gave rise to settled expectations. Are the plaintiffs saying that the FDA’s review and acquiescence meant nothing, or that the FDA erred? Usually not. More often, plaintiffs are prone to suggesting that the defendants somehow bamboozled the FDA. In the feverish dreams of a mass tort plaintiff lawyer, it is a two-fer: the defendant not only lied to the public, it lied to the FDA. Go ahead and read any mass tort complaint and count how many times that story is told.


Still, plaintiffs and their lawyers and their experts are also not shy about asserting that the FDA is not up to the job.  According to the plaintiffs’ parable, the FDA is overworked, lazy, and dumb.  By contrast, it is the regulated companies that hold up FDA personnel as being competent and well-intentioned.  But let’s stick to the fraud claim for a moment. How often do you really think that major drug and device companies intentionally withhold from the FDA material evidence about risks and benefits?  How often do these companies make affirmative misstatements to the FDA, hoping to pull the wool over the government’s eyes?  No individual product approval would be worth such a risk.  Companies try to do the right thing because it is the right thing, and also because it is good business.  A claim of fraud on the FDA is invariably itself fraudulent.

In Buckman, SCOTUS rightly decided that juries have no business determining whether the FDA was fooled. Rather, that is for the FDA to address. If FDA findings or conclusions could be undermined by juries, we would see inconsistent verdicts all around the country, and FDA processes would become virtually meaningless. So now, in the wake of Buckman, we are treated to plaintiff claims and arguments that tip-toe right up to the edge of asserting fraud on the FDA. The plaintiff lawyers want the benefit of nasty implications without blowing up their case with preemption dynamite. Oh, let’s not kid ourselves; edge-schmedge. Plaintiff lawyers cannot help vaulting over the edge and shouting fraud on the FDA. Buckman has given rise to kabuki theater on preemption. It calls to mind that curious phrase about something being “honored in the breach.”

The Meijer case is interesting, not in spite of the fact that it is not a tort claim, but because of it. Meijer is an action brought by a direct purchaser class. The class alleged claims under both the Sherman Antitrust Act and RICO. Surely, dear reader, you know that both statutes are federal. The Meijer opinion does not make it clear exactly why this is so, but everyone in the case agrees that “all of the plaintiffs’ claims are predicated on fraud on the FDA.” The issue, then, is whether the Buckman holding halts these claims in their tracks. It is not a matter of preemption, for all of the claims in Meijer are federal. The supremacy clause is not implicated. Rather, we are now talking about one statute precluding resort to another. The effect of preclusion would be the same as preemption – dismissal of claims.

The district court in Meijer held that the antitrust and RICO claims can proceed, but did so uneasily. The court agreed with the plaintiffs’ reading of the SCOTUS holding in POM Wonderful LLC v. Coca Cola, 134 S.Ct. 1228 (2012), which harmonized Lanham Act claims with the Food, Drug, and Cosmetic Act. But – and the district court acknowledged as much – SCOTUS did not really confront a defense of flat-out preclusion in POM Wonderful. (The phrase “primary jurisdiction” does not crop up in Meijer, but it is not hard to see its relevance here.)

Hence, even though the defendants lost their Buckman argument in Meijer, they convinced the court that the issue was a controlling question of law, that its disposition would materially advance the termination of the litigation (that is, application of Buckman would end the case completely), and there was substantial ground for a difference of opinion. The district court said that “this is the first time a party has brought antitrust claims predicated on fraud on the FDA.” Some of us here at the DDL blog are not so sure that is right.  Be that as it may, it is an open question whether Buckman preemption/preclusion affects claims based on other federal statutes. The POM case focused on statutory interpretation, and followed the maxim of finding consistency wherever possible. There was no reference to Buckman or its underlying principles. The issue was simply not on the High Court’s radar screen. Consequently, the Meijer defendant’s reliance on Buckman is “sufficiently novel,” is purely legal, and therefore warrants interlocutory review by the First Circuit. The very interesting issue of the scope of Buckman has been kicked upstairs.

It will be fascinating to see what the First Circuit does. Courts are loath to permit the mere form of an action to circumvent fundamental principles of jurisprudence. Buckman is fundamental in terms of protecting the integrity and reliability of administrative actions. Consistency and predictability for a vital part of our economy and healthcare are at stake. Dressing up a case in the garb of antitrust or RICO claims should not change things one bit.

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude come from Germany or Florida.  Callers describe News of the Weird headlines, and Carolla and guests try to guess whether the events happened in Germany or Florida.  You can listen to this segment from the old Loveline radio show.

Here are some examples of “Germany or Florida” clues:

  1. Man ate his dog.
  2. Carjacker forced to flee after realizing he could not drive a stick-shift.
  3. Trio shoots at imaginary foe, thereby attracting police to their homegrown meth lab.
  4. Naked swimmer hospitalized after angler hooks his penis.
  5. Man dies after blowing up condom machine.
  6. Sister assaults twin over sexy toy.
  7. Government creates blatant ex post facto law depriving tobacco companies of basic tort defenses.

Okay, you probably know about that last one.  The answers to the others are below.  By the way, Carolla is not alone in identifying The Sunshine State as also being The Sublimely Strange State.  30 Rock had a running gag about Florida craziness.  See examples here.  Also, Seth Meyers on the Late Show runs a “Fake or Florida” bit that can, at best, be charitably labeled as being derivative of Carolla’s gag.  On last Sunday’s Last Week Tonight, John Oliver reported a story about a Florida man who planned to bomb Target stores up and down the east coast, with  the idea of buying up Target stock on the cheap afterwards.  After pointing out how the story involved home-made explosives, a big box store, and a terrible get-rich-quick scheme, Oliver noted that if the story also had a snake on meth, we would have full-on Florida Bingo.

Even before we earned our law license, we were aware that there is something … different … about Florida’s legal system.  In our law school library, you could pull the 12 So. 2d volume off the shelf and it would automatically open up to the Lason v. State case, in which the Florida Supreme Court upheld the conviction of a 76 year old man for “abominable and detestable crimes against nature.”  Some law school libraries have needed to insert photocopies of the Lason case after the original pages were worn out completely.  Good times.

Last week there was a mini-eruption of Florida case law, and we will cover some of those opinions this week.  It is not quite Shark Week for our blog, but it is close.  Today’s case, Wolicki-Gables v. Doctors Same Day Surgery, Ltd., 2017 WL 603316 (Fla. DCA 2d Feb. 15, 2017), is unusual.  The case is ostensibly about spoliation, but it is really about preemption and the dreaded parallel claim exception.  Luckily, the case comes out the right way.  But getting there was like doing a couple of laps on Mr. Toad’s Wild Ride. (You didn’t think you were getting out of this blogpost without at least one Disney World reference, did you?)

Mrs. Wolicki-Gables claimed a physical injury from a failed pain pump system.  She and her husband initially sued the manufacturer of the pain pump, alleging causes of action for strict liability and negligence.  The case was filed in state court, but was then removed to federal court.  The pain pump system had received pre-market approval from the FDA.  Because of that fact, and because of the Supreme Court’s decision in Riegel, the federal court held that the Wolicki-Gables’ product liability claims against the manufacturer were preempted by federal law.  The Eleventh Circuit affirmed the summary judgment in favor of the manufacturer.

Continue Reading Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim