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A couple of years ago we penned a paean to Indiana and its cultural and legal triumphs. Now that another chunk of our family has decided to relocate to that happy state, our thoughts returned to Indiana’s many virtues. Sure, there’s the Indy 500, the fabulous covered bridges of Parke County, the Benjamin Harrison home, and a couple of our favorite in-house lawyers. And now there’s In re Cook Medical, Inc., IVC Filters Mktng., Sales Practices & Prod. Liab. Lit., 2018 U.S. Dist. LEXIS 190177 (S.D. Ind. Nov. 7, 2018).

Maybe plaintiff-files-Daubert-motion isn’t quite man-bites-dog, but it’s still pretty rare. Plaintiffs are usually all about getting to the jury, no matter how raggedy the case. In fact, the more raggedy, the better. Consequently, plaintiffs devote considerably more time fending off Daubert challenges than mounting their own. Maybe there’s a reason for that. Maybe plaintiffs tend to put up hack experts, while defendants put up good ones. Maybe we’re biased. Okay, definitely we’re biased. But take a look at what happened in In re Cook.

The defendants in Cook offered the testimony of a mechanical and materials science engineer who opined that the IVC filter design was not defective and that its benefits outweighed its risks. The expert was well qualified. It’s not as if it was a close call. The defense expert had the appropriate degrees from Cal Berkeley. He also had been a general manager at a company that made IVC filters. Federal Rule of Evidence 702 requires that an expert be qualified by knowledge, skill, experience, training, or education. Note the “or.” This expert had it all. Not only was this expert qualified, he had done the work. He looked at MAUDE adverse event data, peer-reviewed literature, the company’s testing records, the design and engineering records, the opinions of other experts in the case, and fact depositions. That is, the defense expert in Cook did far more homework than virtually any plaintiff design expert we have encountered. We’re not sure we’ve ever deposed a plaintiff design expert who has actually read the design history file. Indeed, we’re pretty sure that most plaintiff experts do not know what a design history file is.

The plaintiff’s main beef with the defense design expert in In re Cook concerns the opinions regarding the device’s benefits and risks. The main benefit of an IVC filter is prevention of pulmonary embolisms. How can a mere engineer opine on medical issues? (Dear Engineering Nerds: Please do not write angry comments; we are using the “mere” word sarcastically. We have endless respect for engineers. We utter a prayer of thanks to them every time we drive across the Benjamin Franklin Bridge. At parties, we always get next to the engineers in case a game of Jenga breaks out.) The court has no problem answering this question: “a biomedical engineer … can testify about the benefits and ability of the Celect IVC filter to catch blood clots from a biomedical design and engineering perspective.” The plaintiffs were asking the wrong question. No surprise there.

Then the plaintiffs raised other wrong questions: (1) Why doesn’t the expert quantify the number of filters that actually prevented pulmonary embolisms? (2) Why does the engineer rely on adverse event data without knowing what percent of adverse events are reported? (3) How dare the expert rely on the defendant’s own studies? The Cook court is untroubled by these wrong questions, and supplies clear, easy, right answers: (1) Quantification goes to weight, not admissibility. (2) No one knows the true adverse event reporting rate, so it’s hard to fault the expert. Also, and again, this criticism might go to weight, but not admissibility. (3) The company’s data might not be perfect, but it looks like valid evidence. The data’s short-comings constitute yet another issue of weight, not admissibility. Finally, the expert relied on lots of other data besides the company’s. In short, tell it to the jury.

We’re still in favor of federal judges acting as stout gate-keepers when it comes to expert testimony. Junk science should be excluded. But when an expert is so well qualified and so well informed as the one in Cook, and when that expert applies reliable methods, there’s no reason to exclude anything. Rather, it’s time for Hoosier hospitality.

A federal judge in one of our non-drug or device cases recently informed the parties that he was so busy with his criminal docket that it might be better to let the magistrate judge take over our case, including trial. We fretted over the prospect of losing a judge who had thus far been very attentive, careful, and rigorous, but the issue was mooted when the plaintiff swiftly said “No thanks.”

Over the years, we have had many good experiences with magistrate judges. Indeed, our last trial in Philly was in front of a magistrate judge, and it would be hard to imagine how it could have been any more fair or efficient. The case we are discussing today, Lynch v. Olympus Am., Inc., 2018 U.S. Dist. LEXIS 185595 (D. Colorado Oct. 30, 2018), was handled by a magistrate judge pursuant to the parties’ consent via 28 U.S.C. 636(c). The plaintiff might now regret such consent, in light of the magistrate judge’s decision, but the clarity and logic of that decision is undeniable.

In Lynch, the plaintiff sued three companies for making endoscopes that were allegedly too hard to clean, thereby causing the plaintiff to suffer an infection and illness. One of the companies was a Japanese parent, and the other two were affiliates that did business in the United States. The Japanese parent moved to dismiss the complaint for want of personal jurisdiction. The affiliates moved to dismiss the strict liability and negligence claims on substantive grounds, and to dismiss the misrepresentation claims for failure to plead with specificity.

The magistrate judge’s opinion is exquisitely organized, so we’ll follow its outline faithfully.

    Personal jurisdiction

The Lynch court considered whether the Japanese parent could be hailed into Colorado based on the stream of commerce theory. That theory is not one of our favorites, and the Lynch court correctly described its fuzziness. SCOTUS has not exactly been very exacting in setting forth the contours of the stream of commerce theory. The Tenth Circuit has been better in erecting this key guardrail: “specific jurisdiction must be based on actions by the defendant and not on events that are the result of actions taken by someone else.” Monge v. RG Petro-Machinery (Group) Co., 701 F.3d 598, 618 (10th Cir. 2012). The Tenth Circuit has also been unambiguous that mere corporate affiliation is insufficient to impute one company’s contacts to its parent corporation. Accordingly, the Lynch court did not feel “free to disregard corporate formalities when assessing whether it may properly exercise personal jurisdiction over a defendant.” What we end up with is another successful example of using marketing subsidiaries to insulate the foreign parent from suit.

Are we done with personal jurisdiction? Not yet. The plaintiff tried to invoke non-registration-related consent by the parent corporation, based on things that happened in other cases. Nice try. Not really. The Lynch court reasonably pointed out that other cases are other cases, and what happened in those other cases has no bearing on or similarity with this case. “A consent in one case does not affect the propriety of a court’s exercise of personal jurisdiction in another case, even if related and even if in the same forum.” The court agreed with the plaintiff that it might be entitled to some jurisdictional discovery — if it could successfully plead the substantive claims, but that, as we will see in a moment, is not so clear.

    Design Defect

Beyond bare conclusions, the plaintiff did not manage to allege that the risks of the endoscopes outweigh benefits in all patients. Potential problems with reuse do not affect all patients on whom new devices are used. “[M]erely being difficult to clean does not render the device unsafe for all all patients.” Moreover, causation requires more than the fact that the plaintiff fell ill after encountering the product. The allegations are too conclusory to state a claim for strict liability under a design defect theory.

    Failure to Warn

Lynch is the first case applying Colorado law to apply the learned intermediary rule to a medical device. No prior Colorado court had explicitly done so, though there was at least one case that generally treated prescription drugs and medical devices together. The plaintiff in Lynch contended that the endoscope was a nonprescription device. Even if that contention was “technically correct,” it did not matter. “Clearly, patients are not buying [endoscopes] over the counter” to administer the procedure to themselves at home. It is necessarily a doctor who “decides the procedure is required and performs it.” To our mind, the Lynch court analysis makes good sense. There are a variety of medical devices that might not technically require a prescription, but there is still no doubt that a doctor is a necessary (and learned) intermediary. Think of scalpels. The doctor, not the patient, selects the particular scalpels employed in a procedure. Would it make any sense to permit personal injury plaintiffs to complain that the scalpel manufacturer supplied inadequate warnings? Scalpels are, sharp, sure. But maybe the manufacturer should have warned that they are very, very sharp. Or maybe there is a materials safety data sheet for one of the scalpel’s raw materials that might give the dense or paranoid pause. The mind reels. For now, let’s content ourselves with the Lynch court’s application of the learned intermediary rule to endoscopes, and the court’s conclusion that the plaintiff did “not allege the failure to warn as applied to her physician.”

The Lynch court made another ruling that is pertinent to many drug and device cases: is the failure to warn really about warning at all? What exactly is the warning and what would be the effect of the warning? In Lynch, the warning allegedly lacking seems to be nothing more than telling doctors that the product is defective. “Plaintiff’s claim is, in essence, that the product was defectively designed and therefore the warning was inadequate; as pled, the failure to warn claim cannot be distinguished from the design defect claim.” Thus, the warning claim boils down to, or takes back to, the design defect claim. And we know how that turned out.

    Negligence and Products Liability

The complaint contained “inadequate factual allegations establishing causation. Absent plausible allegations linking the Defendants’ actions to the Plaintiff’s harms, there is no plausible claim for relief.” Well, okay then.

    Misrepresentation

The plaintiff alleged both fraud and negligent misrepresentation, but the Lynch court correctly points out that there was no real difference between those claims. The negligent misrepresentation claim was replete with all sorts of intentionality. The court concluded that both claims needed specificity and both claims lacked it. The acts of the various defendants were jumbled together, and specifics on who, what, where, and when were wholly absent.

*********************

The plaintiff will get a chance to try again. The magistrate judge was perhaps a bit charitable. But she was also smart and careful, so the plaintiff had better do a much better job on the next go around.

Happy Halloween. We are very old school when it comes to this spooky holiday. Our pumpkins are orange, our candy bowl is full of Kit Kats, and our favorite horror movies are black and white Universal monster movies from the 1930’s and 40’s. To our ears, nothing screams Halloween quite like the great Una O’Connor screaming. See and listen here for examples of her wonderful performances in The Invisible Man and Bride of Frankenstein as a proper lady properly terrorized by creepy creatures. (O’Connor’s last film role was in Witness for the Prosecution as an ear-witness who resisted impeachment.) The Invisible Man, Bride of Frankenstein, and the original Frankenstein movie were all directed by James Whale, a man of enormous talents and humor, as well as enormous tortures. The Gods and Monsters film portrays Whale in his uneasy later days.

At this point, we cannot resist a Halloween joke, this one by Dana Gould. It goes like this: In this country we celebrate a holiday where frightening strangers come to our homes and take goodies from us. We call it Halloween. A month later, the next big holiday arrives – Thanksgiving. But Native Americans have another name for that holiday; they call it … Halloween.

Recently, we found ourselves screaming like Una O’Connor after a plaintiff filed a summary judgment motion against us. That plaintiff had the temerity to argue that her failure to warn claim was a foregone conclusion. Our screams arose from surprise, indignation, and, finally, laughter. With one brain tied behind our back, we could scare up a genuine factual dispute. Take a look at the report by our expert, who is very smart and says our warning was adequate and no reasonable doctor would have been misled. While you’re at it, read our Daubert motion, wherein we demonstrate that the plaintiff experts are about as scientific as Colin Clive in Frankenstein, dancing under the lightning and proclaiming, “It’s alive, alive!” Not quite. Our expert marshals the data and literature and says this about the lawsuit: “It’s dead, dead!”

Plaintiff motions for summary judgment are menacing, but miss the mark more often than not. That was certainly true in Nielsen v. Smith & Nephew Inc. et al., 2018 WL 5282901 (E.D. Wisc. Oct. 24, 2018). If anyone is screaming in this case, it is the judge, obviously pained by bad briefing. The plaintiff alleged that a hip replacement device fractured ten years after it had been implanted. The complaint’s main target was the distributor of the implants, because the manufacturer had gone under. There were 11 causes of action, but a defense summary judgment motion prompted the plaintiff to concede that almost all were pure hooey. Not a great start for the plaintiff. The only real motion fight was on the negligence claim against the distributor. Meanwhile, the plaintiff moved for summary judgment against the distributor on two grounds: (1) that the distributor of the hip devices could be liable under Wisconsin law because the manufacturer had gone bankrupt and lacked insurance coverage, and (2) the device lacked adequate warnings.

To put it mildly, the Nielsen judge was not impressed by the plaintiff’s motion. The plaintiff supported his motion by attaching letters and emails from the manufacturer’s counsel and insurer. That’s all inadmissible hearsay. Consequently, the solvency of the manufacturer — and, therefore, whether the distributor could be a proper defendant — would need to be decided at trial, not on summary judgment. The plaintiff’s summary judgment on product warnings fared no better. The plaintiff’s expert did, predictably, say the warnings should have been more explicit and petrifying. But just as predictably, the defense expert pronounced the warnings to be just peachy. We in the business call this sort of thing a factual dispute. That’s also what the court called it. It was not a close call, as far the court was concerned. The plaintiff “inexplicably declined to dispute any of [the distributor defendant’s] statements of additional facts.” Moreover, the plaintiff offered no relevant case law under Wisconsin’s product liability act. Rather, the plaintiff “seems content to leave it to the Court to find the law that supports his arguments. It will not do so.” Ouch.

The distributor defendant’s motion for summary judgment was more successful than the plaintiff’s motion. (Frankly, it is unimaginable how it could be less successful.) The plaintiff’s motion was premised on his expert’s opinion about what the warnings should have included. But the issue was the warning obligation of a “reasonable distributor.” Amazingly, the plaintiff’s expert addressed only manufacturer duties. Those duties were plainly inapplicable to the distributor defendant, which was “simply a middle man.” The complete failure of the plaintiff to join issue mightily annoyed the judge, who wrote as follows: “Such minimal effort, devoid of any citation to law or meaningful discussion of evidence, is an insult to the Court.” Double ouch. The plaintiff basically brought motions and then made no attempt to prove what he had to prove.

The distributor defendant did not cross-move on every claim. There is still a strict liability claim against it, and that claim will go to trial in November. But based on what happened with the cross motions for summary judgment, if we were the Nielsen plaintiff we would not be sanguine. Nope. We’d be scared.

Happy birthday, Aubrey Drake Graham.  Most people know Mr. Graham strictly by his middle name.  The Canadian rapper Drake has carved out a hugely successful career for himself.  He sells lots and lots of records – or whatever it is that they sell in the music business these days.  Surprise: Drake’s music isn’t exactly our thing.  We still play the Beatles more than anything else, we sing along with Crosby, Stills, & Nash in the car, and we have difficulty naming songs post-dating Nirvana.  (Seinfeld once famously asked, “How could you not like the Drake?”  He was talking about somebody else.  Still, it’s a question we hear frequently from friends and family, chiding us for our retrograde taste in music.) Nevertheless, it’s impossible to swim in this culture without getting at least a little wet from Drake’s songs.  With “Worst Behavior,” for example, we got doused with language that you won’t hear in “Hello/Goodbye,” “Suite: Judy Blue Eyes,” or even “Come as You Are.” The main lyrics in “Worst Behavior” are about remembering how some bad, um, person, didn’t love Drake enough.  Anyway, thinking about that song made us review instances of the worst behavior by plaintiffs we have known and not loved.  There’s outright lying, cheating, and stealing.  And that’s looking only at the Plaintiff’s Fact Sheet.  Sometimes it goes beyond that.  Way beyond that.  Sometimes there’s hiding assets, including one’s pending tort claims, in bankruptcy.  It’s a swell way to stiff creditors.

This is not the first time we’ve encountered a case where a plaintiff neglected to list a mass tort claim as an asset in a bankruptcy proceeding.  See our blogposts here and here, for example.  Such neglect can have serious consequences, including staying or even dismissing the tort claim.  In today’s case, Kinderline v. Accord Healthcare, Inc., (In re Taxotere Prod. Liab. litigation), 2018 WL 5016219 (E.D. Louisiana Oct. 16, 2018), the plaintiff declared bankruptcy first, and two months later brought the mass tort action.  The plaintiff did not amend the bankruptcy papers to identify the claim.  The mass tort being an MDL, it dragged on, and the plaintiff’s bankruptcy closed with the trustee not hearing about the pending mass tort claim.  The plaintiff received a “no asset” discharge from bankruptcy. A fresh start! The plaintiff’s failure to include the tort claim in the bankruptcy proceeding was caught only after she was deposed by the defendant in the MDL.  (See – there’s a reason why that bankruptcy question shows up in your depo outlines.). The plaintiff then belatedly reopened the bankruptcy proceeding to list the tort claim.  The issue was whether the plaintiff was collaterally estopped from pursuing the tort claim in the MDL.

First things first.  Which law governed the estoppel issue? The plaintiff wanted to apply the law of her home jurisdiction, Ohio.   But the application of judicial estoppel is a matter of federal common law, and the case had been transferred to the MDL court in Louisiana, which is part of the Fifth Circuit.    There is precedent, though not by the Fifth Circuit, holding that application of federal (Constitutional, statutory, or common) law is governed by the law of the transferee court.  Judge Fallon in E.D. Louisiana went that route in the Vioxx MDL.  It certainly makes administration of the MDL easier.  (That’s not the same thing as saying it is right.) Even without Fifth Circuit precedent squarely on point, the Taxotere MDL court was convinced that the circuit law of the transferee court held sway, and therefore applied Fifth Circuit, not Sixth Circuit, law.  We’re not sure there is any difference in terms of application of judicial estoppel.  That is usually the threshold issue in a choice of law analysis.  Not so here.

This choice of law rule might be important to you when you are deciding what court you will argue for when it comes to creating an MDL.  Most lawyers tend to focus on the particular judge and district court they like better (or which particular judge and district court most terrifies them), but we should also think about the circuit court.   For instance, we recently argued for sending an MDL to the district of New Jersey.   The judge there seemed quite good.   But we were not blind to the fact that Third Circuit Law on preemption, in the form of the dreaded Fosamax decision, was bad bad bad.  We ended up concluding that Fosamax was so obviously bad that SCOTUS would reverse it.  That’s a heck of a gamble.  Right now, as we mentioned recently when we reviewed the Solicitor General’s amicus brief in Fosamax, it looks like a good gamble.  To quote a musician much more likely to be found in our playlist (and much more likely to be found in the Third Circuit), Fosamax is “going down, down, down, down.”

Back to Kinderline.  The court held that the plaintiff was, indeed, estopped.  Fifth Circuit law on estoppel, like the law in most places, looks at three elements: (1) the party against whom estoppel is sought has asserted a position plainly inconsistent with a prior position; (2) a court accepted the prior position; and (3) the party did not act inadvertently.  The first element was met here because the plaintiff failed to amend her bankruptcy petition to disclose a claim pursued after filing the petition.  The duty to disclose claims/assets in bankruptcy is an ongoing obligation. The second element is straightforward and obviously satisfied, because the court accepted the prior position – hence the no-asset discharge.  Now comes the third element, inadvertence.  To establish a defense of inadvertence, a party must prove (1) that she did not know about the inconsistency, or (2) that she lacked a motive for concealment.  There is no help for the plaintiff in Kinderline there, as there is no evidence she was oblivious to the inconsistency between the filing of the lawsuit and the failure to list it in bankruptcy, and the motive for concealment, keeping creditors away from any proceeds of the lawsuit, is undeniable and has, in fact, been recognized by the Fifth Circuit in another judicial estoppel case.  The plaintiff “would have reaped a windfall if she had been able to pursue this claim and collect a judgment from Accord without having to share the judgment with her creditors.”

The best fact the Kinderline plaintiff had going for her was that she reopened the bankruptcy proceeding before the defendant managed to move for estoppel.  She won the race to the courthouse.  Whoopee.  Not good enough.  The plaintiff did not seek to correct the record until being caught at her deposition and until almost a year after she knew of the lawsuit as asset.  Borrowing from Fifth Circuit precedent, it is clear that to bless the plaintiff’s gamesmanship by allowing the debtor to “back-up, reopen the bankruptcy case, and amend [her] bankruptcy filings, only after [her] omission has been challenged by an adversary, suggests that a debtor should consider disclosing personal assets only if [she] is caught concealing them.”   In other words, there must be consequences for the plaintiff’s bad behavior.  The plaintiff claimed that her delay was caused by her decision to wait to confirm product identification to ensure she was suing the correct party.  Hmmm. Such carefulness on the part of the plaintiff and her attorneys!  Yet it did not stop her from filing the tort lawsuit.  Nor did it account for all of the year-long delay. The plaintiff is not innocent.  For that reason, judicial estoppel means that she cannot pursue her lawsuit in the MDL.

But the Chapter 7 trustee is innocent and is the real party in interest.  The Trustee did not hide assets.  For that reason, the bankruptcy trustee could pursue the plaintiff’s claim.   But here’s an odd wrinkle:  the rejection of the plaintiff’s right to claim on her own behalf meant that her husband’s consortium claim was extinguished, as it was purely derivative of his wife’s claim.  To allude to the title of another Drake song, the husband’s claim was “Over.”

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.

Gather round brothers and sisters, and hear the word of the Texas Court of Appeals. Today’s sermon addresses the intersection of religion and regulation.  Take out your hymnal, and turn to Hawkins v. State, 2018 Tex. App. LEXIS 7863 (Texas Ct. App., 14th Dist. Sept. 27, 2018).  Consider the case of Mr. Hawkins, hereinafter referred to as “the defendant,” but who self-identified as a bishop of the Genesis II Church of Health and Healing.  A primary teaching of said church was the amazing curative power of “MMS,” which variously stands for Miracle Mineral Solution, Master Mineral Solution, or  Miracle Mineral Supplement. (We think of MMS as an abbreviation either for the more prosaic Multimedia Messaging Service or the sillier Make Me Smile.  But who are we to depart from church doctrine?).  MMS is a sodium chloride product typically used as a disinfectant.  It is an industrial bleaching agent.  The defendant held monthly seminars and taught his flock how to mix and consumer MMS.  And what bounty shall this marvelous MMS elixir deliver?  Why, nothing less than a cure for cancer, HIV, heart disease, autism, and Ebola.  So sayeth the defendant.

 

The state of Texas heard this preaching and, lo, announced that it was Bad.  The state filed an action under the Deceptive Trade Practices Act (DTPA). The main prayer for relief was to enjoin the defendant and his followers to refrain from promoting MMS.  Justice in Texas was swift.  The state’s prayer was answered.  The MMS folly was put asunder.  The injunction was issued.  Thusly were poor innocents spared the fate of dousing their innards with bleach and tumbling into the fiery pit of disease and despair.

 

But the defendant gnashed his teeth against this ruling, and filed an appeal.  Alas, his teeth must still be gnashing, because the Court of Appeals decreed that the trial court’s ruling was Right and Good.

 

As a preliminary matter, the trial court quickly disposed of a raft of frivolous arguments, such as that the court had no jurisdiction over a sovereign church, that the government lawyers were unauthorized to practice law, that a church cannot be a dba, and that there was no contract between church and state.  For anyone who clerked and had to attend to tax objector appeals, this litany of beefs will seem familiar.  Sometimes the hardest part for a court or opponent is first to figure out exactly what the argument is, then restate it cogently, then bash it with solid precedent (which is much preferable to the jawbone of an ass, though we have occasionally encountered or even employed that weapon, too, in our almost two score of legal practice).

 

The actual substantive argument by the defendant is the most interesting: that “no one has the right to prevent a church or its believers from teaching its belief and offering its sacraments if the sacraments do not consist of controlled or illegal substances.”  Ah, at last we arrive at the type of lofty issue we might have encountered in Con Law class.  But the religious freedom claim here is framed exceedingly weakly.  The state brought the DTPA action on the grounds that the defendant had engaged in false, misleading, and deceptive ads and practices by promising benefits of MMS that it in fact lacks, by failing to disclose the utter lack of scientific research supporting such claims, and, worst, by failing to disclose the health risks of MMS.  Religious freedom is not a freedom to poison fellow citizens.  That much is clear.   We’d also say that religious freedom is not a freedom to lie to one’s fellow citizens, but even with the passing of Christopher Hitchens we’d expect some debate on that proposition.  But more to the point, religious freedom does not call off neutral application of the state’s police powers.

 

Whereupon the Hawkins court consulted a Higher Authority – the federal Food and Drug Administration.  In 2010, the FDA issued a safety alert about MMS, warning that it was an industrial bleach used for stripping textiles, and that consumption of MMS could lead to nausea, vomiting, diarrhea, and severe hydration.  At least one person suffered a life-threatening reaction after drinking MMS.  That’s the FDA warning against physical harm, not taking sides in some religious schism.

 

What’s the church’s position? According to at least some MMS labels, reactions such as nausea and vomiting were “evidence that MMS is working.”  Indeed, MMS seems to work in mysterious ways.  Some of the most damning evidence resides on the defendant’s website.  Those who adhered to the ways of MMS would know how to fix 95% of mankind’s maladies.  The church claimed to be “superior to health insurance.”  (Okay, our mind might be open about that one.). Learn about MMS, and you can call yourself a Reverend.  Dispense MMS to 50 unlucky people, and you can call yourself Doctor.

 

But the defendant probably should not call himself Lawyer.  For all of his arguments fell on deaf ears.  Hawkins was not a case of religious discrimination.  The police power of the state had not been exercised arbitrarily or capriciously.  Render unto Caesar, etc.  Little wonder that the appellate court wasted little ink in affirming the trial court’s ruling and offering an easy Amen.

 

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.

 

 

 

We’ll get to today’s case in a moment, but first, a few words about SCOTUS and expiration dates.

 
One hundred and one years ago tomorrow saw the birth of Lewis Powell, who served as a United States Supreme Court Justice from 1972 to 1987.  Powell succeeded Hugo Black.  More interesting, considering current events, is that Powell was succeeded by Anthony Kennedy. Whether Judge Brett Kavanaugh succeeds Justice Kennedy is a matter of some some controversy.  One reason for that controversy is that Justice Kennedy was often a swing vote.  In a prior post, we recounted our one close encounter with Anthony Kennedy.  He impressed us a smart jurist who was determined to do the right thing.  Still, it must have seemed somewhat vexing to SCOTUS litigants that everything likely turned on the predilections of one Justice.  The other eight Justices often seemed predictable, almost a done deal.  But Justice Kennedy, at least on some issues, was the wild card.  We have no evidence that Justice Kennedy purposely positioned himself as the swing vote, or that he reveled in his inflated importance, but his importance as a swing vote was undeniable.
 
We have also seen no evidence that Justice Kennedy patterned himself after his predecessor, but it is remarkable how similar they were in locating themselves right at the center of the Court.  Justice Powell was often a swing vote.  If our affirmative action jurisprudence is a bit of a mess, some of the blame for that must go to Justice Powell, whose controlling opinion in the 4-1-4 landmark Bakke decision created a slippery standard that sprung from Powell’s idea of the perfect academic affirmative action program – the Harvard College admissions system.  Even back in 1978, it was pretty obvious that the Harvard system was not quite the holistic, individual-respecting scheme that Powell portrayed. (The legal defense of U.Cal Davis Medical School’s affirmative action program was entrusted to the great Archibald Cox.  During oral argument, Justice Blackmun asked whether the set-aside seats could be compared to athletic scholarships.  Cox replied, “Well, I’m from Harvard … “ – laughter intervened – “I don’t know whether that’s our aim, but we don’t do it very well.”)  Given the current lawsuit challenging Harvard admission policies, the Bakke compromise and its progeny seem even more fragile.  

The story of how Powell came to be appointed to the High Court was told in Bob Woodward’s book, The Brethren. (We hear Woodward has another book out.)  President Nixon was politically hobbled in 1972.  In trying to fill an earlier SCOTUS vacancy, Nixon had two of his selections rejected by the Senate.  Powell was an interesting choice.  He was from Virginia, which fit in with Nixon’s southern strategy.  But Powell would not fit into what we now consider the usual mold.  He had never been a judge. (Black had been a senator, not a judge.  Chief Justice Warren had also been a politician.  Douglas headed the SEC. It used to be acceptable for Justices not have to have a judicial track record.  Why the change?). Powell was a corporate lawyer. He represented the tobacco industry. He was a leader in the ABA.  He wrote a famous memo about how corporate America should deal with a hostile media.  There were plenty of reasons why Nixon would have liked Powell.  But there was one important reason why Powell would be acceptable to Senators who weren’t enamored with Nixon: Powell was 64 years old.  Woodward reported that a Senator waved a cigar and told Powell why he would be confirmed: “We think you’re going to die.”  (Powell himself was not all that fired up to join SCOTUS.  He had turned down an earlier offer.  He did not think he had the constitutional law chops of a Douglas, Black, or Brennan.  Plus, he was not eager for the huge pay cut.)

Recently John Oliver’s Last Week Tonight show argued for eliminating life tenure for judges.   Oliver supported a proposal for staggered 18 year terms.  (Powell served 15 years on SCOTUS.)  Every four year presidential term would include an opportunity to appoint at least two SCOTUS justices.  The system would permit reasonable turnover.  It would avoid the dangers of a gerontocracy.  It might somewhat reduce the temperature of SCOTUS confirmation hearings, since there wouldn’t be a multigenerational impact at stake.  Such a change would require a constitutional amendment.  Spoiler alert: it won’t happen.  But while we’re just dreaming, we have another reason for cuddling up to this idea.  When presidents harbor the hope of appointing a Justice who will support certain policies/rules for thirty years, that means they will select relatively young people.  That elevate-them-when-they-are-young approach also offers the advantage of proffering someone with a limited paper record and a limited target area for skeptical senators. Thus, instead of a SCOTUS appointment being the capstone of a long, distinguished career, it is more and more conferred on jurists in mid-career.  As we slouch toward dotage, we less and less like the idea of such important jobs going to juveniles.  Frankly, we hate seeing presidents and Supreme Court Justices younger than ourselves.  It is an annoyance almost as painful as being forced by some website to enter our birth year in a drop down menu, and scrolling down and down.  And down. 
[Quick quiz: Which Supreme Court Justice served the longest term?  Answer below.]

Why are we pondering these issues at this moment?  Obviously, the ongoing Kavanaugh kerfuffle is top of mind.  We also find ourselves ruing life tenure when we read a judicial decision that seems gruesomely wrong-headed.

And now we get to today’s case.  
 
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In Sumpter v. Allergan Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), the plaintiff brought suit over ruptured silicone breast implants.  The implants were premarket approval (PMA) medical devices.  As the Sumpter court acknowledges, the Medical Device Amendments Act “preempts claims challenging the safety and effectiveness of … PMA devices.”  Federal law dislodges any state laws (including via jury verdicts) that are “different from, or in addition to, any requirement applicable under [federal law].”  In the face of this rather clear preemption, the plaintiff in Sumpter ditched her design defect and failure to warn claims.  All that was left was the claim for manufacturing defect.  And here begins the Sumpter court’s descent into sheer awfulness.  As a preliminary matter, the Sumpter court tells us that, “[g]enerally, manufacturing defect claims that allege the ‘manufacturer failed to adhere to the specifications imposed by a device’s PMA’ are not preempted at the pleading stage.”  That quote is from the 2009 Hofts decision out of the Southern District of Indiana.  More than once, this blog has derided Hofts for its mangling of Riegel and Twombly and Iqbal.  Hofts made our list of the ten worst decisions of 2009.  Most courts that have considered Hofts have rejected it.  But not the Sumpter court.  If anything, Sumpter manages to multiply Hoft’s errors.  First, the plaintiff, as is all too typical, never comes close to specifying what the manufacturing defect was.  Second, the Sumpter court’s standard for assessing what constitutes a manufacturing defect is altogether wrongheaded.  A manufacturing defect happens when the product is out of spec from its design,  Something about the particular product is different from a product that is manufactured correctly.  Maybe something is in there that shouldn’t be, or something is missing.  Ot a component was flawed.  But that is not the Sumpter court’s test.  No, the Sumpter court concludes that a claim for manufacturing defect will lie when plaintiffs say that the products differed from the “intended result.”  What does that mean?  Presumably, a case was brought because someone was injured.  That is never the “intended result.”  Does “intended result” end up requiring a perfection that exists nowhere in the law, on any assembly line, in any product portfolio, or, indeed, on our planet? Moreover, the mere existence of a malfunction cannot, by itself, give rise to an inference that the manufacturer violated the FDCA.  Where is there any basis to invoke the infernal Riegel “parallel violation”?  Through the Sumpter looking-glass, every product liability case contains a manufacturing defect claim destined for a jury.  
 
The closest the plaintiff came to articulating a semi-specific manufacturing defect claim was an allegation of “material fatigue.”  Was there any hint in the case that the materials in the implants at issue were in any way out of spec, or different from the norm?  Nope.  Rather, the plaintiff “extrapolated from the injuries” that “there must have been a manufacturing defect.”  Goodbye TwIqbal.  Goodbye whatever is the relevant state law on manufacturing defect.  Hello, new-fangled res ipsa loquitur theory, even though the Sumpter court never uses those magic Latin words.  Under the Sumpter court’s reasoning, once one claims injury from a product, there’s a manufacturing defect that is immune from a motion to dismiss.  (Unless, one supposes, one is in an outlier case where the product was intended to inflict injury.  And then, surely, there is another legal claim at hand.)  The Sumpter court has defectively manufactured a tort claim that, by all rights, should be dismissed based on well-established, clear SCOTUS precedent.
 
The only consolation is that, as we have pointed out many times before, manufacturing defect claims are hard to win.  The odds are long against the likelihood that the plaintiff will ever demonstrate a true manufacturing defect.  Then again, erroneous jury instructions could wreak havoc in favor of even an empty claim, and how can we predict that won’t happen?
 
Justice Powell once said that history “teaches us tolerance for the human shortcomings and imperfections which are not uniquely of our generation, but of all time.”  Tolerance, indeed.  Plus, unlike with SCOTUS, the Sumpter court might some day get reviewed by a higher court.  And then there is the highest authority of all: the DDL blog ten-worst list at the end of this year.  
[Answer to question:  William O. Douglas sat on the High Court for 36 years and 211 days.  He was confirmed at the age of 40.  The judge we clerked for had clerked for Douglas, and could never utter WOD’s name without a growly follow-up along the lines of “…that bastard.”  Apparently Douglas, while being brilliant and charismatic, was not always very nice.]

This isn’t the first time we’ve written about the Hyde case in the Bard IVC Filters MDL.  Back in July we reported on some pretrial rulings in that bellwether case.  Get ready for more.  The decision on tap for today, Hyde v. C.R. Bard, Inc., 2018 WL 4215028 (D. Arizona Sept. 4, 2018), is sort of a man-bites-dog item, as it involves a motion in limine by the plaintiffs to exclude warnings information.  Generally, we on the defense side are the ones arguing to keep prejudicial information out, so the posture of Hyde is interesting.  Just in case you haven’t committed the facts of Hyde to memory, here’s a refresher:  Mrs. Hyde received an IVC filter implant in 2011.  Three years later, she learned that the filter had tilted, perforated the IVC wall, and fractured.  The plaintiffs brought a lawsuit sounding in various theories.

[Interlude for discovery.  Interlude for motion practice.]

Applying Wisconsin law, the Court granted summary judgment on the failure to warn claims. (As we reported back in July, the plaintiffs proffered no evidence that a different warning would have inspired the doctor to employ a different device or do anything differently.)  That ruling left claims for strict liability design defect, negligent design, negligence per se, loss of consortium, and punitive damages.  In advance of trial, the plaintiffs filed a motion to exclude the device’s instructions for use (“IFU”) and certain guidelines published by the Society of Interventional Radiologists (“SIR”).  Usually, plaintiffs love to trot out the IFU and point out offending lacunae. What’s different here?

The plaintiffs argued that because the failure to warn claims had been dismissed, the instructions and warnings set forth in the IFU were no longer relevant to any issue in the case and should therefore be excluded.  Similarly, the plaintiffs argued that the SIR guidelines, which evinced the knowledge of IVC filter complications in the medical community, were no longer relevant in the wake of dismissal of the failure to warn claims.  According to the plaintiffs, design defect must be tested against consumer expectations, and the IFU and SIR guidelines play no role with respect to such consumer expectations.   Plainly, the plaintiffs wanted the IFU and SIR guidelines out.  The defendants wanted them in.   We’re guessing the IFU warnings must be quite clear and that the SIR guidelines must be quite helpful for the defense.

Luckily for the defendants, Wisconsin law was quite clear and quite helpful for them.  In 2011, the same year as the plaintiff’s implant, the Wisconsin legislature enacted tort reform that included adoption of  section 2 of the Restatement (Third) of Torts (1998).  (We wrote about the cheesehead tort reform here.)  Section 2 employs a risk-utility balancing test and consideration of a broad range of factors, including the instructions and warnings accompanying the product.  Consumer expectations are in that broad range of factors, but no longer make up the whole ballgame. They definitely are not a basis for excluding information otherwise relevant to safety.

Under post-2011 Wisconsin law, a jury must consider not only whether there was a reasonable alternative design, but also whether a failure to adopt that design rendered the filter “not reasonably safe.”  Can the IFU and the SIR guidelines help a jury answer that question?  Almost certainly, yes.  The SIR guidelines lay out the acceptable rates of risk in IVC filters. Thus, they are relevant to the jury’s determination of whether the filter was reasonably safe.  The IFU tells physicians about risks of the filters and how to mitigate them.  That information, too, is relevant in determining whether the filter was reasonably safe.  The defendants are free to argue to a jury that the warnings provided with the filter “disclosed the risks of complications, that the medical community was aware of those risks and found them to be acceptable, and that the omission of an alternative design therefore did not render the filter ‘not reasonably safe.’”

Moreover, the IFU and SIR guidelines are relevant to the plaintiffs’ punitive damages claims.  The plaintiffs will surely try to persuade the jury that the defendants acted with “malice.”  But what the defendants, via the IFU,  told physicians about the device’s risks is relevant to whether the defendants acted with “intentional disregard for patient safety.”   The SIR guidelines are relevant to the defendants’ “awareness of filter complication rates and the extent of harm posed by filter complications, and can also inform the jury of risk levels found acceptable by interventional radiologists – a relevant fact for deciding whether Defendants ‘acted with a disregard for patient safety.”

We began this post by remarking how odd it seemed that it was the defense that wanted warnings information in, and the plaintiffs that wanted it out.  It also seems a bit odd to us that it is the plaintiffs who are insisting on a strict line of demarcation between different tort theories (failure to warn vs. design defect), and the defense who treat the line as kind of fuzzy.  But we’ve seen something like this before.  You needn’t strain your memory too much to recall how in the Bartlett case the plaintiff tried to evade preemption by arguing that the case was only about design defect and that failure to warn was out of bounds.  The defense demonstrated that there were aspects of the design defect claim that were implicated by preemption principles.  The result was a resounding defense SCOTUS victory that many of us are trading heavily on today and expect to do so for a good long while.

“Thinking out of the box” has become a hackneyed phrase, but sometimes it is perfectly accurate.

 

 

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.