We would be hard pressed to think of a recent judicial decision we have blasted as hard or often as the Third Circuit’s Fosamax opinion.  We deemed it the worst case of 2017.  It was bad enough that our hometown federal appellate court held that it was up to a jury whether the FDA would have rejected a stronger drug warning.  It was worse that the court held that a defendant had to prove by clear and convincing evidence that the FDA would have rejected the warning.  And it was still worse, and kind of weird, that the Third Circuit arrived at this holding in a case where the FDA actually had rejected a stronger warning.  The result of the Fosamax decision was that summary judgement in favor of the defense on preemption became a pipe dream, and ultimate victory at trial became a lot tougher.

Right from the start, we thought Fosamax was reversal bait.  The excellent certiorari briefing made us more sure of that.  Then, when SCOTUS invited the government to lob in an amicus brief, we became still surer.  Now that we have read the government’s brief, we are even surer. Lawyers from the Solicitor General’s office and the Department of Health and Human Services are on the brief.  These lawyers are typically brilliant and the positions they stake out typically command a lot of respect from courts.

When we clerked, our Judge always paid a lot of attention to government amicus briefs.  In the last SCOTUS case we worked on, the government’s position turned out to be pretty much dispositive.  We represented a father who had been tossed in the clink because he had failed to pay child support.  It was a civil contempt proceeding that ushered him into jail.  The state (South Carolina) did not provide him counsel because it wasn’t a criminal case.  We argued that however the case was styled, if imprisonment was a possibility, the right to counsel was implicated.  The other side was represented by then Penn Law professor, now Third Circuit Judge, Stephanos Bibas, who was an amazingly effective advocate for what we thought was a weak position.  We argued that counsel had to be provided and he argued not so.  Then the SG’s office filed a brief, and its answer split the difference: sometimes.  Guess what SCOTUS decided?  Sometimes won.

What do we have here with the government’s Fosamax brief?  The headline is that the government argues for reversal of Fosamax.  It argues that the Third Circuit erred in holding that, under Wyeth v. Levine, a jury must resolve the preemption defense “As a factual matter subject to a clear-and-convincing evidence standard.”  Yay. But is there a ‘sometimes’ aspect to the government’s position that makes us a bit uneasy?  Yes, there is.

As always, the statement of the Question Presented sets the tone.  Here is how the government frames the inquiry:  “Whether a state failure-to-warn claim alleging the insufficiency of brand-name drug labeling is preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., when the Food and Drug Administration, after the drug manufacturer provided it with the relevant scientific data, rejected the manufacturer’s application to modify its labeling to warn about the risk underlying the tort claim.”

The first thing we notice is that the government is focusing on the fact that the FDA did actually reject a proposed warning.  That rejection came in the form of a Complete Response Letter in 2009.  The central point in the government’s brief is that the meaning and effect of that Complete Response Letter presents legal questions that a judge, not jury, must resolve. It was a federal agency decision, and courts, not juries, interpret agency decisions.  Even if factual findings are necessary to interpret the federal agency decision, such factual findings are decided by the court, not the jury.

The government’s arguments on these points are compelling, and it is hard to see how reversal can be avoided.  But how useful would reversal on this ground be for the rest of us?  Whenever the FDA actually rejects an enhanced warning, there will be an agency decision, and the government’s analysis would kick in and make the issue legal, not factual.  But what if there is no rejection?  What if the defendant wants to argue that there are other circumstances, not quite reaching the level of an actual agency rejection, that demonstrate that such rejection would have been inevitable?  Are we still in fact-land, as opposed to legal-land?  The ruling in Fosamax might end up a little narrower than we’d like.

Let’s not dwell on these questions for now.  No point in being a nervous Nellie.  There are other goodies in the government’s brief.  For instance, while the Third Circuit in Fosamax speculated that possibly the FDA’s rejection was a result of dissatisfaction with the specific language proposed by the pharmaceutical company, the government smacks that position down and restores the focus to the proper place: the state of the scientific evidence. Look again at the Question Presented.  Hone in on this language:  “relevant scientific data.” The FDA looked at the data in the available literature and adverse events reports.  “No sound basis thus exists for concluding that the FDA determined in May 2009 that the data was sufficient to warrant a warning but that it rejected petitioner’s proposal because of petitioner’s proposed text.”  If SCOTUS adopts this reasoning, as it should, plaintiffs will have one less arrow in their speculative quiver to stave off summary judgment on preemption.

Even better is how the government brief eviscerates the clear-and-convincing evidence standard.  First, the brief makes the undeniable point that the Wyeth v. Levine decision simply did not address this issue.  Thus, we are thrust upon first principles.  This is a product liability case. It is a civil action for money damages, and “nothing warrants a higher standard of proof to resolve the preemption question here.”  Absent legislative specification, there is no basis to impose a higher evidentiary standard on defendants seeking to available themselves of SCOTUS preemption doctrine.  We are not entirely fond of the government’s explanation of the Wyeth “clear evidence” language, seeming to tie it into a presumption against preemption, but we are trying not to be churlish.  In any event, we are content with the government’s fundamental point that the Wyeth v. Levine  “clear evidence” formulation was not intended “as a shorthand for a formal clear-and-convincing evidentiary standard, but merely to indicate that a manufacturer asserting preemption must show that a labeling charge was not warranted under the relevant statutory and regulatory framework.”

Once the government shows that resolving the Fosamax case requires resolving a legal issue, that no factual findings are required, and that the preponderance of the evidence standard applies, the case becomes easy.  The FDA rejected the proposed warning because the data was not yet in place to justify the warning.  The Third Circuit got it wrong, the district court got it right, and the litigation should be over.

The toughest thing about defending product liability cases is the occasional immersion in human misery.  Securities and antitrust cases pose intellectual challenges but they are, in the end, pretty much about money.  By contrast, the plaintiffs in our cases are claiming injuries to their bodies, not just their wallets.  Sometimes those alleged injuries are phony or trivial.  Mostly, though, they are real.  You wouldn’t wish them on your worst enemy.  Every once in a while, the alleged injury is unspeakably sad.  That sadness hits us extra hard when the injury involves a child.  For instance, several of the plaintiffs in SJS-TEN cases were children.  Try to imagine what it would be like to be on the other side of the courtroom in such cases.  And then there are cases brought after a child or adolescent committed suicide.  No parents want to outlive their children.  And the ending of a life so prematurely must be devastating.  It must also be infuriating.  It would be natural to blame the catastrophe on a drug.  It might even be right to do so.  Or it might not.

 

In Patton v. Forest Labs, Inc., 2018 U.S. Dist. LEXIS 160368 (C.D. Cal. Sept. 19, 2018), the plaintiffs alleged that their daughter committed suicide after taking the antidepressant Lexapro.  After some dismissals and amendments, the Second Amended Complaint (SAC) was teed up for another motion to dismiss. There were claims for relief based on negligence, violation of California’s Unfair Competition Law (UCL), and wrongful death.  The claims were based on allegations that the anti-depressant was marketed in such a way as to mislead the FDA, doctors, pharmacists, and the public about suicide-related risks. In considering the motion to dismiss the SAC, the court “again extends its condolences.”  But the court still dismissed the SAC without leave to amend.

 

The central obstacle for the Patton SAC was that the suicide warning was quite clear.  The Highlights section of the Lexapro label contained a boxed warning about the “[i]ncreased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.”  The plaintiffs argue that the warning should have been stronger.  One can always conceive of ways to enhance a warning, but the possibility of such enhancements does not mean that the original warning was not adequate.  The label warned in plain and explicit terms of the specific risk that caused the alleged injury.  The plaintiffs’ pleading as to why the failure to say more in the warning constituted negligence was, to say the least, confusing and amorphous.  The plaintiffs pointed to nondisclosure or understatement of risks, and also inserted allegations of other misconduct, including purported violations of a Corporate Integrity Agreement.  None of it mattered, because the Patton court held that the warning at the relevant time was adequate as a matter of law.

 

The Patton court also held, after reciting the holdings in Levine, Mensing, and Bartlett,  that the warning claims were preempted because the plaintiffs could not point to any newly acquired evidence to support a label change. (This same issue was central to the case we discussed yesterday.)  Moreover, there was another reason why the usual resort to the Changes Being Effected provision would not work: the change to the suicide warning would need to appear in the Highlights section, and changes to the Highlights section cannot be done without prior FDA approval.  (The inability to make unilateral changes to the Highlights section might ride in to the rescue of many defendants.)  The Patton plaintiffs argued that preemption did not reach claims for breach of warranty and fraud, but there was no claim for breach of warranty, and the fraud claim (part of the UCL) did not come close to satisfying the heightened pleading requirements for fraud claims, because it involved statements allegedly made to “unspecified audiences at unspecified times.”

 

The Patton plaintiffs’ fundamental contention was that the defendants were required change the drug label based on new information (even if we do not know exactly what the new information was).  The Patton court’s rejection of this argument is worth quoting:  “While it is obvious that the FDA, in approving the relevant Lexapro initial labeling and not yet requiring Defendants to change their label, disagreed with Plaintiffs, even if the FDA were wrong, only the government (i.e., not Plaintiffs) may bring a lawsuit to enforce the FDCA and the FDA’s regulations requiring Defendants to change their label.”  The Patton court then cited Buckman, completing the quartet of essential drug and device preemption SCOTUS cases.

 

Because this was the Second Amended Complaint, and because futility had been demonstrated to a fare thee well, the Patton court dismissed the SAC with prejudice.  Thus was a sad tale brought to its conclusion.

 

 

 

Recently Rudy Giuliani was broiled for saying that the truth isn’t the truth.  Denying a tautology won’t typically earn one high marks for logic.  Add in the callback to Pontius Pilate’s “What is truth” question, and it sounds like bad epistemology in service of bad morality.  But we’re not here to talk politics.  Nor are we here to try to answer Pilate’s question.  Maybe the Drug and Device Law Daughter, who is just starting her second year at Harvard Divinity School, can field such questions.  We cannot.

As a former prosecutor of mail frauds and wire frauds and as a current defender of companies accused of consumer fraud, the question we have faced is usually more along the lines of “what is a lie.” It is not merely the opposite side of the street, though it surely is in the same neighborhood.  Liars are everywhere.  They overstate their income when applying for a loan.  They understate their income when reporting to the IRS.  They use sucker lists to lure retirees into investing in nonexistent oil wells.   They loot companies via creative accounting.  They tell us our table will be ready in “just a few minutes.”  They tell us our flight is “On Time.”  They check the box saying they have read and they accept the terms and conditions.  They pretend not to want the last slice of pizza.

What makes something a lie that leads to liability?    Even putting aside the difficult issue of discerning a defendant’s intention to prevaricate, how does the law tackle claims that someone did wrong by uttering something at odds with the truth?  The police are not the truth police, and civic dockets could not bear the strain if every lie led to a lawsuit.  So the law has introduced concepts of materiality and detrimental reliance.  A lie is actionable only if it made a difference. It had to have fooled someone who is not a fool.  It had to have caused harm.

One summer, between our junior and senior years in college, we worked in the New Jersey legislature.  It was the summer of the FBI’s Abscam investigation (see American Hustle).  A couple of politicians, including a U.S. Senator, six members of the House of Representatives, a New Jersey State Senator, and the Mayor of Camden, did perp walks on their way to corruption convictions.   But the legislators and staffers we worked with were a competent and honorable group.  One of them focused on consumer fraud matters.  He told us that anytime a state investigator wanted to ring up some citations, all that was required was a visit to a nearby supermarket.  Weigh some packaged meat, compare to the stated weight, and – voila! – there would almost certainly be a discrepancy.  Evaporation and the passage of time produced a lie.   Thankfully, a rule of reason prevailed.   Nobody was really deceived or hurt.   Let’s be grownups about this.   There are plenty of real frauds to pursue.  It wasn’t cynicism; it was realism, aided by a set of reasonable priorities.

Years later, we found ourselves in Southern California.   It’s hard to say why it’s so, but it quickly became clear to us that folks on the west coast were a lot less tolerant of puffery or even the slightest deviation from their idea of truth and purity.  Is it a state of innocence?  Does life under perpetually sunny skies foster a heightened sense of entitlement?  Look at the lawsuits alleging that a company incorrectly called its product organic or natural.  They are not all filed in California, but it seems that most of them are.  Even so, most of those lawsuits don’t get much traction in the courts, because a regulatory agency had made a determination  of what could and could not be put on a product label.  In such cases, courts don’t need to engage in science, or semantics, or epistemology.  It turns out that sometimes Pontius Pilate’s question is preempted.

Today’s case originated in Southern California: Welk v. Nutraceutical Corp., 2018 U.S. Dist. LEXIS 135595, 2018 WL 3818033 (S.D. Cal. Aug. 10, 2018).  The plaintiff had purchased liquid vitamin B12 and complained that the packaging overstated its contents.  The claim centered on test results from a “reputable supplement analysis center located in California” showing that, once opened, the liquid vitamin B12 “undergoes degradation at an unknown rate.”  After only 11 days, a sample of the product weakened from 255 ug/ml to 213 ug/ml.  The plaintiff contended that the amount of B12 eventually “becomes negligible and ineffective.” Thus, the bottle’s label was “untrue, false, and misleading.”  The complaint included various actions for misrepresentation, and did so on behalf of a purported class of consumers.

Tell the truth: this claim does not exist unless it is a class action, right?  And what does that tell you?

Stepping back for a moment, doesn’t this claim remind you of the statement on cereal boxes about how the contents may have settled? When you are a child, this statement might possibly have arrived as unpleasant news.  Open a box of Cap’n Crunch, and one is greeted by almost as much air as nuggets of cavity-inducing goodness. But as adults, we read this statement with calm resignation.  Perhaps that is because we, too, our bodies and our minds, have settled over time.

The defendant in Welk moved to dismiss the claim for various reasons.  The best of those reasons was that the claim was preempted by the Food, Drug, and Cosmetic Act, as amended by the Nutrition Labeling and Education Act.  There is an express preemption provision barring state law food labeling requirements that are “Not identical” to federal regulations.  The FDA regulates the labeling of the “quantitative amount” of nutrient supplements such as vitamin B12, and decrees application of a specific testing methodology.  The defendant’s labeling complied with the FDA’s labeling and testing methodology.

How does the plaintiff endeavor to evade preemption?  The plaintiff argued that the defendant improperly failed to disclose the fact of degradation.  But that assertion of degradation rests upon a testing methodology that is certainly not “identical” to the one mandated by the FDA.  Accordingly, the court, in a very short, very to-the-point decision, held that the plaintiff’s misrepresentation claims were preempted and must be dismissed.  Was the vitamin label a lie?  Not really.  As with many of the cases we encounter, the alleged lie was one of omission.  Tell me more, says the plaintiff.  One can always think of more.   How to decide?  There’s a scientific test.  Who decides?  The FDA.

We cannot count ourselves surprised by the result in Welk.  It is consistent with several others we have seen in food and nutraceautical cases.   But we do count ourselves as envious.  Most of our cases involve drugs and medical devices.  (No surprise there; take a look at the title of this blog.  Please don’t accuse us of false advertising because today’s case involves neither a drug or device.  We’re about to tie it together, okay?  Okay.  Here goes.). The preemption language for medical devices is there, but it’s been unduly watered down by a couple of courts.  The logic for preemption of drug labeling is there, but it, too, was overly cabined in some regrettable judicial decisions that are starting to collapse from their contradictions. (Many of those decisions indulged in a presumption against preemption – a presumption that has since been discredited.) Imagine if food preemption rules applied to all the products regulated by the FDA. Think of the logic, consistency, clarity, and efficiency.  We could use a little more of that in the DDL world.

That is no lie.

Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts.  Yikes.  And it is not as if the bad appellate decisions were spread around.  Two came from our home circuit, the Third.  Two came from the reliably problematic Ninth Circuit.  But the ‘winner’ was the Eleventh Circuit, with three terrible opinions.  For defense practitioners, Eleventh Circuit precedents can create something of an obstacle course. 

 

It turns out that good federal district judges in SEC country also can be frustrated with what their appellate brethren hath wrought.  Last week we were sent an interesting example of this: Rowe v. Mentor Worldwide, LLC, No. 8:17-cv-2438-T-30CPT (M.D. Fla. March 2, 2018).  In that case, the plaintiff sued for negligence, strict liability, and breach of warranty arising out of injuries allegedly caused by a silicone gel breast implant. The breast implants are class 3 devices requiring premarket approval from the FDA.  The plaintiff’s implants had ruptured.  The plaintiff asserted that the defendant failed to conduct proper studies and failed to warn about known risks.  The defendant filed a motion to dismiss.  The district court wrote a thorough and well-reasoned opinion, concluding that all of the claims save one must be dismissed.  All of the claims would have been dismissed had it not been for a pesky Eleventh Circuit case that is unsound and inconsistent with other Eleventh Circuit cases.  The district judge acknowledged being stuck, but was none too happy about it.  The Rowe court’s opinion is laid out logically, and we will do our best to track it.

 

Pleadings

 

The court addresses “a growing plague on the justice system, which has wreaked havoc in this case and numerous others: poorly drafted pleadings.” Slip op. at 4. We get an Iqbal name-check.  The Rowe court recognizes the liberalities of notice pleading, but also recognizes that “[t]here is a point, though, where a pleading becomes deficient not because it lacks sufficient allegations to provide notice of claims, but because it buries those allegations among pages of irrelevant and impertinent material.”  Id. at 5  The complaint in this case was 60 pages, with 151 pages of exhibits.  The negligence claim includes “six separate negligence theories that are confusingly interwoven among each other.”  Id. at 5.  In short, the plaintiff “threw every allegation into the Complaint to see what would stick.”  Id. at 6.  But instead of throwing out the complaint wholesale, the court examined the particular causes of action to see which ones, in fact, would stick.

 

Preemption Overview

 

For its preemption analysis, the Rowe court largely relied on the recent Eleventh Circuit decision in Godelia.  That ends up having its ups and downs.  But the general preemption analysis is straightforward enough.  The threshold questions is whether the claims are valid under Florida state law, which governs the case.  If not, those claims are gone.  If so, the next questions is whether those claims are preempted by federal law.

 

Negligence failure to warn 

 

The plaintiff does not allege that the defendant failed to give the warning required by FDA. Therefore, the plaintiff must be seeking to impose a warning requirement that is different from or in addition to federal law.  Such a claim is expressly preempted by statute. Slip op. at 9.

 

Failure to report adverse events 

 

As any even semi-faithful reader of this blog knows, we think this claim is hogwash.  It should fail both on simple causation grounds as well as preemption.  We wrote about this issue earlier this week.  Some of you might know that the Ninth Circuit is a devilishly bad place for defendants on this issue.  But the Rowe court is not in the Ninth Circuit.  Instead, it is Eleventh Circuit law that supplies the framework, and this is one area where the Eleventh Circuit is pretty good, as it sees failure to report claims under Florida law as essentially alleging a claim of fraud on the FDA, which is preempted by Buckman. Slip op. at 10.

 

Failure to comply with federal laws 

 

The claims under this category pertain to alleged breaches of federal requirements and regulations. One example mentioned in the complaint is failure to do required studies.  But Florida law imposes no such requirement. So this claim flunks the preliminary test.  Even if the claim somehow survived that test, it would be impliedly preempted.  Id. at 11.

 

Negligent misrepresentation  

 

The plaintiff offered only the most general allegations of failures to disclose the risks of the implants. The court deemed these allegations to fall far short of Fed. R. Civ. P. 9(b), which requires specificity of fraud allegations.  The plaintiff “never identifies what the misrepresentations were, when they were made, how they were made, where they were made, or who made them.”  Id. at 12. In any event, the misrepresentations seemed to involve what was and was not told to the FDA.  Accordingly, those claims are impliedly preempted under BuckmanId. at 13.

 

Negligence per se 

 

Violation of a federal statute does not establish negligence per se if there is no federal private cause of action.  No such federal private cause of action exists here.  The complaint does not state a parallel claim, and is therefore impliedly preempted. Id. at 14.

 

Manufacturing defect 

 

Everything had been gliding along so smoothly up to this point.  Now we hit a rough patch.  The plaintiff alleged deviations from requirements in the device’s PMA, departures from good manufacturing practices, and vague failures to exercise care in the manufacturing process.  The defendant argued that the plaintiff never pointed to any device-specific requirements. It supported its argument by citing WolickiGables (11th Cir. 2011).  The Rowe court agreed that the Wolicki-Gables standard would require dismissal of the complaint.  But recent Eleventh Circuit decisions in Mink and Godelia cut the other way.  “The holdings in Mink and Godelia are directly at odds with Wolicki-Gables and appear to announce a new standard the Eleventh Circuit is directing courts to apply.”  Slip op. at 16-17.  (We listed Mink as the eighth worst DDL case of 2017.  Here is the post where we explained why we think Mink stinks.)  The Rowe court felt stuck.  Under recent rulings, the plaintiff could conceivably state a claim under parallel requirement.  At the same time, the court recognized that the “negligence count is nearly eviscerated by the Court’s ruling on the other theories.”  Id. at 17.  This, just to ensure there really is some there there, the court directed the plaintiff to replead the one surviving claim in an amended complaint. 

 

(This kerfuffle over what to do about competing circuit precedents reminds us of our time clerking on the Ninth Circuit, which is so huge and spread out that, believe it or not, inconsistent holdings proliferate.  What to do?  Assume there was  no en banc decision, which is what it should take to alter circuit precedent.  Does a panel need to follow the earlier or later decisions.  Your instincts might prompt you to conclude that it is always the most recent precedent that controls.  But if the recent decision’s reversal of precedent was improper, maybe even illegitimate, because it did not go the en banc route, should it really command respect?  We wrote a bit on this issue last year, as part of our extended Fosamax mourning period, and argued that the earlier precedent should control and the later deviation deserves no respect.)

 

 

Strict liability – failure to warn 

 

The analysis here is the same as for negligent failure to warn, and so is the result: preempted. Slip op. at 18.

 

Strict liability – manufacturing defect 

 

Remarkably, the result here is different from the negligent manufacturing defect claim.  For some unknown reason, the plaintiff did not ladle any specific federal requirements into this claim. Instead, the plaintiff simply relied on good manufacturing practices.  Not good enough.  Such allegations do not pass muster under either old or new Eleventh Circuit precedent.  Id. at 18.

 

Breach of implied warranty 

 

Plaintiffs constantly toss in warranty claims as an apparent afterthought.  Or maybe it is a no-thought.  The Rowe case is controlled by Florida law, and Florida law requires privity.  That is all perfectly obvious.  Equally obvious is that breast implants are not available for purchase directly by consumers.  The plaintiff pretty much conceded absence of privity and absence of a legal basis for proceeding with this claim, by not responding to the argument.  The court dismissed the warranty claim. 

 

Final scorecard

 

All that is left is the negligent manufacturing defect claim.  That should be a hard one for the plaintiff to win.

 

It occurs to us that good district judges such as Rowe’s are not the only folks who must grit their teeth and do battle with the Eleventh Circuit’s doctrinal wanderings.  Defense DDL practitioners are in the same boat.  We can relate, inasmuch as the Third Circuit (think of Fosamax) has done us few favors lately.  So we commiserate with excellent defense lawyers such as the ones who fought for and won as complete a victory as reasonably possible in the Rowe case.  Congratulations to Dustin Rawlin, Monee Hanna, and Allison Burke of Tucker Ellis, and David Walz of Carlton Fields.

 

 

There are plenty of f-words in this post, but fear not, for they are all fully capable of traveling in polite company. Most are even family-friendly. The most tasty f-word here is the “F” in FDA: food. While we focus on drug and device cases in this blog, we frequently find that food cases furnish fine fodder for some of the legal issues we fiddle with, such as in this 2008 post on food as a four letter word.  Food cases can also suggest flanking maneuvers to prop up our favorite f-word defense, federal preemption. For example, feast your eyes on the recent case of Organic Consumers Ass’n v. Hain Celestial Grp., Inc., 2018 U.S. Dist. LEXIS 1053 (D.D.C. Jan. 3, 2018). The plaintiff alleged that the defendant’s infant formulas were falsely labeled as “organic” because they contained products that flunked the federal Organic Food Production Act of 1990 (“OFPA”). The defendant filed a motion to dismiss the complaint on the ground that private enforcement of organic labelling is preempted by the OFPA.

The court fastidiously began with the standing issue, and held that the Organic Consumers Association had standing to sue. Then the court forfeited some more goodwill with us by presuming that “Congress does not cavalierly preempt state causes of action.” Such reference to a presumption against preemption is foolish and makes us feel forlorn. (As we have blogged before, the presumption against preemption has fallen by the wayside when it comes to express preemption.)  At this early point in the decision, we are fidgeting and fuming. But then the court mentioned another, much more formidable principle: that “the purpose of Congress is the ultimate touchstone.” That further point should foreclose the need to indulge in any feckless presumption against preemption, because, in enacting the OFPA, Congress made forcefully clear its purpose to establish national standards for marketing organic products, to assure consumers of consistency, and to facilitate interstate commerce of organic products. These purposes were folded into a USDA final rule that created the National Organic Program, with regulations requiring that a product can be sold as “organic” only if it contains at least 95% organically produced products, with the remaining five percent consisting of synthetic ingredients included on a “National” list. The OFPA also provides for a “certifying agent” to certify a manufacturer’s fidelity to an approved organic plan.

The products in question in the Organic Consumers case were certified, but the plaintiff argued that such certification is not synonymous with OFPA compliance. The plaintiff argued that its lawsuit would not foil the federal scheme but, in fact, was faithful to it. That position seems to be, in a literal sense, fantastic. The plaintiff’s position certainly failed to convince the judge.

This is not the first case to face the issue of preemption under the OFPA. Far from it. In the only appellate case on point, In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., 621 F.3d 781 (8th Cir. 2010), the Eight Circuit held that any attempt to hold the defendant liable under state law for products mislabeled as organic would directly conflict with the OFPA and the role of the certifying agent. The Eighth Circuit rejected the defendant’s express and field preemption arguments, but concluded that the plaintiff’s lawsuit present an obstacle to the federal scheme. Permitting private suits to challenge the federal certification of a product as “organic” would result in different interpretations and different enforcement, inevitably plunging manufacturers and consumers into a fog of confusion. Based on the fundamental need for uniformity, the plaintiff’s claims were fatally preempted.

We are unabashedly fond of the Aurora case, and we are hardly alone. F. Supp. 3d is filled with cases that followed Aurora’s reasoning. (We will not make the mistake of praising the Aurora court for its “fulsome” reasoning. “Fulsome” is not a dressed-up stand-in for other, perfectly adequate words such as “complete,” “thorough,” or, perish the thought, the simple, direct “full.” Most uses in our presence of the word “fulsome” are wrong.  We become flush and fight hard to contain our fury. You see, we adhere to the primary dictionary definition of “fulsome” as “excessively flattering.” Yes, we have become fossilized. We follow Fowler’s Modern English Usage – the oldest, crankiest edition. Get off our lawn.)

But, of course, there is one pesky fluke out there: Segedie v. Hain Celestial Grp., Inc., 2015 U.S. Dist. LEXIS 60739 (S.D.N.Y. May 7, 2015). Not to put too fine a point on it, but the Segedie is not a favorable decision to those of us who are fans of preemption. The reasoning in Segedie is sheer folly, but one cannot be sure that some other courts won’t flock to its flawed logic just because of SDNY’s fame. The Segedie court found fault with Aurora‘s preemption analysis, and concluded that private enforcement of what is and is not “organic” would boost consumer confidence, and that the risk of divergent interpretations did not present a “sharp” obstacle to uniformity. That logic is hard to fathom. We were not aware that the degree of “sharp”-ness – whatever that is – is a factor in preemption analysis.  Segedie is a flop.

The Organic Producers court sided with Aurora and declined to adopt the faux reasoning of Segedie. Permitting a plaintiff to sue on the basis that a product labeled and federally certified as organic is not, in fact, organic runs afoul of all three purposes of the OFPA:

1. Local fact-finders can be fickle and there is no reason to expect uniformity from their outcomes. Forget about ever having a national standard. What is “organic” in Florida might not be on F Street in D.C.
2. Consumers would be flummoxed by the different rules governing what is and is not organic.
3. Rather than foster interstate commerce, the differing outcomes would provide the worst possible feedback to food manufacturers – they would not be able to sell their products in certain parts of the country where some jurors decided that the “organic” should be forbidden for such products.

Naturally, the plaintiff fought against the flow of this reasoning. The plaintiff made a foray into the usual anti-preemption fallback position that states can impose more restrictive standards. But the plaintiff forgot that the federal system included an enforcement system that never mentioned private enforcement but, rather, forged a system of inspections, compliance reviews, suspensions or revocation of certifications, and other civil and criminal penalties. Permitting private enforcement would be unnecessary and would flirt with disaster.

We are not merely fond of the Organic Producers because it is a fair statement of food preemption. Nope. We think that Organic Producers represents a return to first principles of preemption law, which are just as applicable to personal injury drug and device litigation as to food labeling. Flipping issues of drug or device product defect and adequate warning to various jurors scattered around the country, including jurors flailing about in that fever-dream litigation festival known as an MDL, wrecks uniformity, fans the flames of confusion, and is a fist to the gut of interstate commerce. Rather than flatter jurors, we ought to acknowledge that their foibles and the varying, frenzied, irrational outcomes they permit plaintiff lawyers to foist on the public are a rotten way to fix health and safety problems.

The pro-preemption holding in Organic Producers flat-out makes sense. It should flourish. It should be the way forward.

We’ve come to expect top-flight work product from the Product Liability Advisory Council (PLAC), even when it isn’t Bexis pushing the pen or pecking at the keyboard (as he has done so many times on so many important issues). PLAC’s amicus brief in support of the petition for certiorari regarding the Third Circuit Fosamax case is no exception. See Merck Sharp & Dohme Corp. v. Albrecht, et al., 2017 WL 4310719 (Appellate Petition, Motion and Filing) (Supreme Court of the United States Sept. 25, 2017).  Three weeks ago, in our post entitled The Third Circuit Fosamax Preemption Error Has Got To Go,  we discussed the defendant’s excellent petition for certiorari. The petition articulated the pain we felt from the Third Circuit’s misinterpretation of the “clear evidence” preemption test.  That misinterpretation is clearly wrong and clearly pernicious. The Third Circuit took the already tough “clear evidence” language from the SCOTUS Wyeth v. Levine test, tweaked and twisted it, added a few words, and transformed it to make impossibility preemption virtually impossible. The Third Circuit held that a defendant could not invoke preemption without clear and convincing evidence to prove to a jury that the FDA would have rejected the plaintiff’s proposed warning. Because the clear and convincing evidence standard is so demanding, and because the court threw a quintessentially legal question to the jury, the Third Circuit made summary judgment on preemption a vanishingly slender hope.  Perhaps that was the idea. 

 

 

Well, it’s a bad idea.  It’s bad law and bad policy.  The certiorari petition made a strong case for SCOTUS to take the Fosamax case and clean up the mess made by the Third Circuit.  Now the PLAC brief makes a strong case for reversal even stronger.  The PLAC brief truly is brief.  We recently praised brevity, and the PLAC brief shows the power of concise clarity. PLAC begins by reminding SCOTUS that conflict preemption is grounded in the Supremacy Clause of the Constitution.  PLAC also reminds SCOTUS that the Third Circuit’s erasure of conflict preemption took place in the context of an MDL involving more than a thousand cases.  That means that, even aside from precedential toxicity, the Third Circuit’s decision had a huge effect on the federal docket.  A key plaintiff claim in those 1000+ cases is that the manufacturer should have provided a stronger warning regarding the risk of bone fractures.  After a bellwether trial, with full development of a complete regulatory record, the Fosamax district court concluded that preemption was warranted because the record was clear that the FDA would have rejected the suggested label change.  How clear?  The FDA did, in fact, reject a label change.  That apparently was not clear enough for the Third Circuit.  The Third Circuit vacated and remanded the district court’s carefully considered ruling, discounting undisputed evidence.  It got to that result by changing “clear evidence” to “clear and convincing evidence” and changing a legal question into a factual question.

 

PLAC argues that it is important for SCOTUS to get involved because the Third Circuit’s decision adds to lower court confusion on the meaning of “clear evidence.”  As we have discussed before in this space, one can find cases with similar records and diametrically opposed holdings.  Compare Robinson (7th Circuit)(Posner holds that clear evidence compelled preemption)(see our post herewith Reckis (Massachusetts)(reaching opposite holding based on crazy reasoning)(see our first post on Reckis here).  The Third Circuit’s reasoning is even crazier than Reckis, and what drove that reasoning was language from cases having nothing to do with preemption.  But if one follows the “clear evidence” trail back to SCOTUS cases such as Geier and English, the evidence is clear that SCOTUS meant “clear evidence” to mean evidence of an actual, not merely potential, conflict.  SCOTUS never hinted that “clear evidence” referred to a heightened, “exacting,” “stringent” standard of proof unique to drug labeling cases.  If SCOTUS intended to impose a “clear and convincing” evidence standard (something, by the way, which would seem to be a legislative determination) it would have done so … clearly.  Moreover, in Geier, SCOTUS explicitly rejected an argument that a defendant invoking preemption must shoulder a “special burden.”     

 

PLAC also demonstrates that the Third Circuit’s Fosamax decision ignores SCOTUS preemption teachings and will cause harmful consequences.  Preemption is such a powerful and important defense because it can cut off meritless litigation before parties incur enormous expenses.  But the Third Circuit’s Fosamax decision permits a plaintiff to keep the litigation meat-grinder going merely by speculating that the FDA ‘might’ have rejected a warning if the language or circumstances occupied a counterfactual scenario only a millimeter away from reality.  That outcome is not only wasteful, it is perverse given recent SCOTUS preemption decisions in Mensing and Bartlett rejecting speculations about what FDA might or might not have done.  The outcome is also wasteful because it invites companies to shower the FDA with proposed label changes that might produce the “clear evidence” that will hit the tiny bullseye maybe-possibly left open by the Third Circuit.  Finally, PLAC contends that stomping out the preemption defense means that drug companies will more and more be at the mercy of the varying tort laws and jury attitudes in 50 states.  That sort of exposure and uncertainty could make a difference at the margins.  If even one innovative drug goes undeveloped because an innovator is scared off by the litigation lottery, that is one drug too many. 

 

Our original title, about how the Third Circuit Fosamax decision has “Got to Go,” came from The Sopranos. This time, the PLAC petition reminded us of a historical reference, one that came up in an odd way during the testimony of the previous director of the FBI:  will no one rid us of this meddlesome case?

 

Last week we were going through the regulatory record of a drug that is now the subject of mass tort litigation.  This effort is central to assembling, per the SCOTUS Wyeth v. Levine case, “clear evidence” that the FDA would not have approved whatever label change the plaintiffs are advocating.  Then we remembered something.  It was even worse than remembering that we left the stove on, or that we left the garage door open, or that we root for the Phillies. We remembered that our case would be governed by Third Circuit precedent, and that the Third Circuit had done its best in the Fosamax case to make it impossible to get summary judgment on preemption.

As we blogged back in March, the Third Circuit in Fosamax reversed summary judgment for the manufacturer and held that it is a question for the jury whether the manufacturer had proved with clear and convincing evidence that the FDA would have disapproved the exact warning suggested by the plaintiffs.  Throwing what was really a legal issue to the jury and wrapping said issue in a heightened evidentiary standard that neither the Supreme Court nor any other court of appeals has ever adopted was doubly wrong, wrecked the law on preemption, and presented the plaintiff bar with an undeserved gift that would ultimately decrease drug innovation and increase drug prices.  What was truly bizarre about the Fosamax decision was that the FDA had, in fact, rejected the warning.  That is about as “clear” a bit of evidence as one could imagine.  But that rejection was not good enough for the Third Circuit, which wondered whether the rejection might have turned on the particular wording of the warning.

The Fosamax decision is such an obvious, pernicious error that, in the words of Tony Soprano’s crew members when another gangster becomes much too troublesome, it “has got to go.”  (The Sopranos was set in North Jersey, which is, in fact, in the Third Circuit, so the analogy isn’t too overwrought.)

The petition for certiorari in the Fosamax abomination has been filed, and it is a beauty. You can read it here.  If it doesn’t catch the Supreme Court’s eye and alert it to lower court destruction of preemption precedent, it is hard to imagine what would. To begin with, the petition does a magnificent job of doing that thing we were all taught to do in law school: stating the issue in a way that seems to compel the right – and winning – answer.  Here is the question presented according to the petition:  “Is a state-law failure-to-warn claim preempted when the FDA rejected the drug manufacturer’s proposal to warn about the risk after being presented with the relevant scientific data; or must such a case go to a jury for conjecture as to why the FDA rejected the proposed warning?” Petition at i.  See what we mean? Asking a jury to conjecture about motives is plainly silly, especially in the face of an FDA rejection of a warning.

The Third Circuit’s decision turns on dithering over whether the FDA might have approved the warning if it had been phrased slightly differently. The petition places this speculative misadventure in the context of a larger trend of lower courts erecting substantive and procedural hurdles to the preemption defense because lots of judges simply don’t like preemption.  The Fosamax decision is especially crazy because it invites “a lay jury’s psychoanalysis of why the agency had blocked compliance with local law.”  Petition at 2.  There are two key aspects of the Fosamax preemption test. First, the panel took the “clear evidence” language from Levine and twisted it into a requirement that a defendant prove it is “highly probable” that the FDA would have rejected the label change.  That bit is hard enough. But the second step really builds in the impossibility of establishing impossibility preemption: because the issue of whether the FDA would have rejected a proposed change is “counterfactual,” the question must go to the jury unless there is a “smoking gun” rejection letter from the FDA that would leave the jury no choice but to find the state-law claim preempted. Petition at 12.

This sort of manifest error needs correction, and SCOTUS has demonstrated a proclivity for granting review to correct lower court decision that limited or circumvented (or, as the petition says on page 15, “defied”) preemption. See Mensing and Bartlett.  The petition also takes us on a tour of rotten preemption decisions, such as Reckis (Mass. 2015), Mason (7th Cir. 2010), In re Prempro (8th Cir. 2009), and Hutto (La. Ct. App. 2011).  We are unsurprised to see a decision from our own Commonwealth represented in this preemption Hall of Shame:  Gurley (Pa. Super. Ct. 2015). But the Fosamax error reaches a high-water mark because it makes it virtually impossible for a brand name drug manufacturer to establish preemption, as plaintiff lawyers and their paid experts “can always dream up some ‘hypothetical’ reason why the FDA might have rejected a proposed warning – and under the decision below, that suffices to reach a lay jury.  The jury would then be asked (case-by-case) to guess as to why the federal regulator blocked the manufacturer’s state-law compliance.” Petition at 14. The way in which the rule was concretely applied in Fosamax highlights its absurdity: “[E]ven though the FDA did reject Merck’s warning, the jury could conjecture about the FDA’s reasoning and thereby conclude that the agency would not have rejected the warning had Merck improved its draftsmanship.”  Petition at 25.

The Fosamax transformation of Levine’s “clear evidence” language into a heightened “clear and convincing evidence” standard abrogates the strong default rule in civil litigation that matters are to be proved by a preponderance of the evidence. Petition at 26.  Typically, courts await direction from the legislature before raising the evidentiary burden.  But the much-abused presumption against preemption, coupled with judicial hostility to preemption, apparently works doctrinal wonders  Moreover, the requirement that the clear and convincing evidence eliminate any possibility that the FDA might have arrived at a different decision from some theoretical change in circumstances or warning language is at odds with the teaching of Mensing and Bartlett that theoretical possibilities should not dislodge preemption. (Further, as we pointed out in an earlier post, the Fosamax determination that clear evidence preemption is a matter of fact for the jury is fully at odds with Third Circuit precedent that preemption is a question of law for the court.)

The petition concludes with an incisive discussion as to how the Fosamax erosion of preemption “threatens the pharmaceutical industry and the FDA’s regulatory role.” Petition at 31.  The manufacturer in the Fosamax case voluntarily disclosed risk information to the FDA, and the FDA rejected an enhanced warning.  To be found liable under such circumstances is ridiculously unjust, and places companies in a quandary. Meanwhile, the FDA’s rejection would be merrily second-guessed by juries around the country – a veritable nationwide festival of cynical counterfactualism.

The petition is so well reasoned, and the Third Circuit’s error is so egregious, that we harbor optimism that SCOTUS will take the case and, once again, clean up the law of preemption.  Two relatively minor references in the petition caught our eye.  First, we are told that it was Justice Alito who extended the time to file the petition for certiorari.  Petition at 3. Second, there is a quote from Justice Alito’s prescient dissent in Levine, where he warned against allowing “juries in all 50 states … to contradict the FDA’s expert determinations.”  Petition at 31, quoting Levine, 555 U.S. at 626. Justice Alito comes from the Third Circuit.  We are hoping he has a keen interest in ridding the law of an error created by his home Circuit.

It is also possible that the petition will induce SCOTUS to invite the FDA, now under a more pro-defense (and, we hope, pro-preemption) commissioner, for its views.

It is quite unusual for a state trial court to depart from that state’s highest court precedent.  But consider that old Hebrew National frankfurter advertising campaign: “We answer to a higher authority.”  If the United States Supreme Court comes out with a case that renders your state supreme court’s opinion null, void, or wrong, you go with SCOTUS.  That is what happened in Russell v. Johnson & Johnson, Inc., 2017 WL 2261136 (Ky. Circuit Court May 8, 2017).  To see intervening SCOTUS authority dislodge a vexing state ruling is remarkable enough.  When that SCOTUS authority compels application of preemption – well, you just know we’re going to blog about it.

The plaintiff in Russell alleged injuries from a cardiac ablation procedure in which doctors used an “SF catheter.”  The plaintiff’s claims included strict liability, design defect, negligence (including failure to test), failure to warn, breach of warranties, fraud, unjust enrichment, and violation of Kentucky’s consumer protection statute.  The defendant filed a motion for judgment on the pleadings, arguing that the SF catheter was a Class III medical device that had gone through the pre-market application (PMA) process, thereby earning the protection of conflict preemption.  That is, no state jury could, via its verdict, impose obligations on a defendant that were in any way different from the FDA’s federal scheme.

If a product went through the PMA process, product liability litigation involving that product is usually a laydown.  No matter what theories are invoked by the plaintiff, preemption applies.   Sure, there is that annoying “parallel violation” exception, which we have written about endlessly, but let’s for the moment put that aside and pretend that the Supreme Court in Riegel had never penned that unfortunate dicta, and that appellate courts around the country had not wrestled with that same dicta in ways various and often incoherent.  This doctrinal confusion really is an instance of “what the SCOTUS giveth, the SCOTUS taketh away,” for it was the Riegel decision that established medical device preemption, and it was the Riegel case that permitted the Russell court to dispense with a bothersome Kentucky precedent.

The complication in the Russell case is that the SF catheter at issue had gone through several modifications since the initial PMA approval.  The SF catheter used in the procedure was part of an FDA-approved clinical trial under the auspices of an FDA investigational device exemption (IDE).  The legal question front and center in Russell was whether the IDE regulations involve the same sort of rigorous, device-specific safety requirements as the PMA process, such that full-blown preemption should apply.  The Russell court held that they did, and that preemption therefore foreclosed all of the plaintiff’s claims.

The plaintiff resisted preemption by contending that the SF catheter at issue did not receive PMA approval until 14 months after the procedure.  On the date of the procedure, all the SF catheter had going for it was an IDE, and a Kentucky Supreme Court decision back in 1997, Niehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997), had held that certain state law claims were not preempted in a case involving an intraocular lens used during a clinical trial under an IDE.  That non-preemption ruling would seem to be squarely relevant and binding precedent — save for Riegel, which SCOTUS decided 11 years after Niehoff.

The facts in Niehoff were distinguishable from Russell in two significant ways: (1) the product in Niehoff never received PMA approval, whereas the SF Catheter in Russell had, and (2) unlike the plaintiff in Niehoff, the plaintiff in Russell had signed a lengthy, FDA approved consent form acknowledging that the medical procedure in question was investigational. Even aside from those factual distinctions, the Russell court concluded that Riegel and its progeny made clear that the IDE procedure involved the same rigorous safety review process as pertains to a PMA, and that preemption applied. We do not know of a single IDE case after Riegel that has failed to apply extensive PMA preemption. Put another way, an IDE was much more like the PMA process covered by Riegel preemption than like the 510(k) substantial equivalence process that the earlier Lohr decision held did not merit preemption.  Plus there is the additional fact that the device in Riegel had gone through the PMA supplemental process, making it very like the SF catheter in terms of FDA posture.  (It really pays to read the details of a case, not just the headnotes.)

Once the Russell court decided that Riegel preemption applied to the SF catheter, the rest was easy.  Would the causes of action impose requirements different from or additional to the federal requirements?  The answer for every claim in the complaint was Yes.  And now inevitably, we come to the issue of whether there was a parallel violation alleged.  The Russell court reasoned that such a parallel violation must include: (1) a violation of a specific federal regulation (that “specific” is important and right away makes the Russell decision better than most), (2) a violation of an identical state law duty, and (3) a showing that violation of the federal rule caused the injuries. The plaintiff’s claims failed this test.  For one, the plaintiff alleged no deviation from the IDE requirements. Beyond that, the plaintiff’s claims essentially demanded that the defendant do more (secure a more detailed informed consent) or say more (additional warnings) than required by the federal scheme.  That is the stuff of preemption, not any parallel violation, and the court dismissed all of the plaintiff’s claims with prejudice.

Not that our readers are dying for a glimpse behind the curtain into the making of the sausage (and mixed metaphors) of the blog, but we do try to first figure out what decisions may be blogworthy before we start writing up the posts each week. We cannot say how blogworthiness relates to spongeworthiness, but we do know that the former involves asking a few questions, one of which is “is this just the same old same old?” In other words, even if the decision comes from a product liability case with a drug or device and addresses something that we think matters, we will not write about it if it adds nothing more than being another decision like we have seen many times before. Maybe it will be added to some cheat sheet or other compilation post, but it will not be worthy of its own post on this illustrious blog. (So illustrious are we that have noticed other blogs trying to rip off our name in the hopes that they will confuse search engines into directing traffic their way.)

When Levine came out with its misreading of the CBE regulation and novel “clear evidence” standard for impossibility preemption, we certainly did not think it would become so commonplace for prescription drug manufacturers—branded, in particular, although the liability of generics was not much of a concern then—to win warnings claims based on preemption. We are not yet there, but we can envisage a day where wins like in Seufert v. Merck Sharp & Dohme Corp., No. 13cv2928, 2016 WL 3369512 (S.D. Cal. May 11, 2016), just end up in our handy-dandy Levine cheat sheet For now, Seufert is still blogworthy.

Here are the basic facts. Plaintiffs sued over allegedly inadequate (absent) warnings on a purported risk of pancreatic cancer with two anti-diabetes drugs—the same compound is in each, with one adding metformin—within a class of drugs called incretin mimetics or incretin-based therapies. There are a number of approved drugs in this class, including one with its active ingredient derived from Gila monster venom. The two at issue were approved in 2009 and 2010 and there has been some degree of attention by FDA to a proposed risk of pancreatic cancer since they came on the market. It is not clear if plaintiffs contended that there was pre-marketing evidence of a pancreatic cancer risk specific to these two drugs, but we assume they did not have much if anything. In 2009, FDA reviewed adverse event data for the class of drugs and concluded “a causal association . . . is indeterminate as this time.” In 2013, FDA issued a “Drug Safety Communication” stating that it was analyzing the issue of pancreatitis and pancreatic cancer with the class of drugs, but that “it had not reached a new conclusion regarding whether incretin mimetics cause pancreatic cancer, and advised health care professionals to continue following the prescribing recommendations in the drug labeling”—which did not mention pancreatic cancer. Based on the plaintiffs’ case numbers, it looks like this Communication started them suing.

Continue Reading Another Prescription Drug Warnings Preemption Decision