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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 as 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.  Or 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.

It’s vacation time for many of our colleagues.  Bexis shrewdly commenced a hiking holiday in Kauai, just in time to greet a hurricane.  We were less adventurous.  For us, it was enough to knock back poutine and ice wine and walk the old city walls in Quebec.  There was one excursion to watch the Drug and Device Law Heirs zip-line over a 272 foot high waterfall.   We did not participate.  Our courage is weak, our girth is large, and our parenting skills are sub-par.  Meanwhile, a leading Philly litigator shared photos from his African safari, proving he got within a paw’s swipe of a leopard.  Yikes.  And then there was our cherished friend, an esteemed in-house lawyer, whose family cruise along Alaska included close encounters with whales, wilderness, and  eerie blue ice bergs.  It all looked marvelous. 

 

We’ve been to Alaska once ourselves, but it was only a business trip.  A couple of oil companies, one of which was our client, had a slight disagreement as to who owned how much of certain tracts.  A few inches here or there meant billions of dollars.  The stakes were high but the issues were dull.  We visited  Prudhoe Bay (mile marker zero of the Trans-Alaska pipeline) and the Captain Cook Hotel in Anchorage, where an enormous stuffed Kodiak bear stands guard.  A popular t-shirt said, “Split Alaska in Two and Make Texas the Third Largest State.”  Alaska is full of wild, wonderful things, but not so much litigation.  Our fossil fuel battle was in arbitration, not the court system.  What sane Fortune 100 executive would entrust complex geological issues to twelve jurors?   

 

Maybe there are some riveting cases from Alaska, but we are hard-pressed to think of many.  In any event, when we think of Alaska, we think of its stunning beauty and the rugged individualism of its residents.  (That last sentence is a bit of ham-handed foreshadowing.) 

 

Quick: name the greatest Alaska television show.  (Answer below.)

 

Today’s case, Cole v. Gene by Gene, Ltd., 2918 WL 3980308 (9th Cir. Aug. 21, 2018), originated in Alaska.  It’s pretty interesting, as it involves the intersection of two increasingly important issues: genetic testing and disclosure of private information.  It’s also pretty good, as it resulted in rejection of class certification.  But the issues must have seemed pretty obvious to the Ninth Circuit, as the panel members felt no need for oral argument and determined that the opinion was unworthy of publication in the West Reporter.  The plaintiff, suing on behalf of a putative class of 900 Alaskans, alleged that a company had disclosed DNA results without informed consent and in violation of the Alaska Genetic Privacy Act.  From the very short opinion, we cannot tell much about the nature of the genetic testing that occurred.  We don’t know whether it was of the broadly available spit-in-a-test-tube, mail-it-in, then learn-with-surprise-that-your-family-actually-hails-from-Transylvania sort, or whether it was of a higher order of complexity and significance.  No matter, because genetic testing is going to become more and more prevalent and more and more crucial.  Selection of future drug and device therapies are likely to become more targeted with the help of genetic testing.  Genetic information is valuable information.   But, like all information, it can fall into the wrong hands and be misused. 

 

Back to the case at hand.  In Cole, because there were too many differences among the class members on important issues, the district court declined to certify the class.  Common issues did not predominate over individual issues, and individual litigation looked to be the superior mechanism for resolving the claims.  The plaintiff appealed.   The plaintiff lost.

 

The Ninth Circuit, applying an abuse of discretion standard or review, affirmed the district court.  It held that individualized determinations predominated with respect to the key issues of disclosure, consent, and damages.  For instance, whether a particular customer had private information disclosed varied depending on the terms of release signed by the customer, which of the thousands of genetic “projects” the customer may have joined, the terms of the specific project a customer joined, and what privacy settings the customer chose.  The district court was right that individual issues outnumbered the broad-brush general issue.  Moreover, the district court did not abuse its discretion by denying class certification on superiority grounds. The plaintiff had failed to carry his burden to show that “a class action is superior to other available methods for fairly and efficiently adjudicating the controversy.”  In particular, the damages available to aggrieved customers under Alaska law would be plaintiff-specific.  Couple that intractable fact with the “difficulties inherent in managing a class action featuring such distinct and individualized issues, the limited resources to be saved by certifying a class, and the absence of other pending or duplicative lawsuits in the Alaskan courts, “ and it becomes clear that “individual litigation is a superior mechanism for resolving” the case. 

 

(It is equally clear that Northern Exposure was the best tv show ever set in Alaska.  It was filled with original, sharply drawn characters.  Individuality certainly predominated.  The main character was a doctor from New York who made it through medical school on a loan funded by the state of Alaska.  To repay the loan, he had to practice medicine for a couple of years in a remote Alaska town.  Other characters included an ex-con who was the ultra-philosophical disc jockey in the town’s only radio station, a bush pilot whose former beaus all died gruesome deaths, a cantankerous ex-astronaut, and the owner of the town tavern who was at least 40 years older than his wife, but worried he would outlive her because the men in his family invariably lived past 100 and invariably spent a decade or so as lonely widowers.   The show ran on CBS from 1990 to 1995 and won many awards.  Among those were Emmy and Golden Globe awards for best drama.  The producers were grateful for the awards, but felt obligated to mention that they thought the show was actually a comedy.  In fact, Northern Exposure was one of the first “dramedies,” containing both comedic and dramatic tones.  After the first couple of seasons, a new producer-writer named David Chase joined the staff of Northern Exposure.  Perhaps you have heard of Chase.  Earlier in his career he had worked on The Rockford Files.  Later, he created another show with quirky characters.  It was called The Sopranos.)       

 

We are on vacation this week.  The aim was to stay in this hemisphere, yet get the feel of being in an old European city.  Less air travel, but still with the overcharging and the hard stares in response to our dodgy foreign language skills.  So with that hint, guess away as to our present location.  As part of vacation prep, we downloaded a bunch of movies on our Netflix account for viewing on the plane and in case of a rainy day.  A couple of days ago, with gritted teeth, we hit the play button for a documentary film called “The Bleeding Edge.”  We deal all the time with claims of failure to warn, but in this instance we have no such claim.  We had been fully warned that the film was a thoroughly one-sided screed against the medical device industry.  Pity the poor defense lawyer picking a jury tainted by this particular work of art.  The case studies in the film involve hip implants, a contraceptive, vaginal mesh, and robotic surgery.  Rotten Tomatoes gives the film a score of 100%.  This film must be a banger, right?

 

Well, it is certainly effective.  True to its title, it draws blood – emotionally, anyway. It conveys a series of stories, it makes you feel sorry for victims, and it makes you mad.  It feels very much like an extended 60 Minutes segment.  60 Minutes has been on the air for 50 years.  That’s 50 years of confronting corporate and government malefactors. 50 years of crooks scurrying away from cameras.  50 years of righteous indignation.  Many times over those 50 years, 60 Minutes worked its forensic magic on us.  We were just as swept up in the disillusionment and the urge to punish as any other viewer. 

 

And then, when we began our stint at a law firm, we worked on a case that received lots press coverage.  To our shock, the press got at least half the story wrong.  The account of who, what, where, when, why, and how was terribly tilted – more a morality play than factual reportage.  Eventually, it occurred to us that perhaps the press didn’t distort reality only for stories about our cases.  Maybe, just maybe, flaws riddle press stories fairly (or unfairly) often. 

 

We have worked on litigation involving only one of the products at issue in “The Bleeding Edge.” All of the stories are compelling, with human beings who earn sympathy.  Some suffered terrible physical injuries.  Even beyond that, some of their lives were ruined in other ways, with awful impacts on family members.  You’d have to have a heart of stone to be unmoved.  For the story dealing with the product we know a little something about, vaginal mesh, the story turns out to be a half-story.  The viewer will see nothing about the vast majority of patients who had their lives bettered by mesh – whose stress urinary continence, which had devastating, embarrassing consequences for quality of life, had been fixed. Instead, we hear from a plaintiff lawyer who delivers a mini-closing argument against mesh. He says that when the science conflicts with the marketing, “the marketing always wins out.”   That’s catchy, but that’s also a canard.  From what we have seen, medical device marketing claims must run the gauntlet of careful medical, regulatory, and legal scrutiny before any member of the public sees them.  We also hear from ubiquitous plaintiff expert David Kessler, a former head of the FDA, who rips into the 510(k) “loophole”.  You will not hear a hint of why that provision was deemed necessary and how there was at one time enormous discontent about undue delays in making beneficial medical devices available to patients.  If there is a legitimate, nuanced debate about whether the scope of the 510(k) process should be adjusted, or whether that regulatory pathway should be bolstered or adjusted when the underlying predicate devices are withdrawn, you won’t hear that nuanced debate here.  It’s all black and white, albeit in cinematic color.  Then we hear from another plaintiff expert who wields a rhetorical axe, not scalpel, against mesh.  Immediately afterward, we hear from a plaintiff. When she mouths a critique of vaginal mesh, she says she has heard it is like trying to remove rebar from concrete.  Guess where she heard that?  That is precisely the imagery used by the plaintiff medical expert in his trial testimony.  To our jaundiced eyes, these interviews were cleverly curated and assembled for maximum negative impact.  That is not documentary; it is choreography.

 

If “The Bleeding Edge” is one-sided – and it is – its defenders will say that is the fault of the companies.  At the end of the film, we get the typical screen notification that the filmmakers invited the companies to appear, but the invitation was declined.  Can you blame the companies?  First, it was clear that the filmmakers was dead set on putting scalps on the wall.  It was inevitable that the questioning and editing (more on the latter in a moment) would be deployed to make the companies look bad.  The filmmaker, not the interviewee, has final cut. Second, companies in litigation know that any public statement could be used against them.  By contrast, a plaintiff lawyer can say whatever he wants without worrying that an inaccurate statement might be used against one of his clients.  Thus, there is a structural reason why public reporting on matters in litigation usually favors plaintiffs.  There is also the same bias one sees in scientific journals in favor of finding significant results.  “Product Injures Thousands” will attract more eyeballs or clicks than “Company Responsibly Pursues Innovation.”  For good reason is the film entitled “The Bleeding Edge.”  If it bleeds, it leads.  

 

There is an appearance in the film by the CEO of AdvaMed, the medical device industry association.  We first see him making a presentation to the MedTech Conference.  In the excerpt selected by the Bleeding Edge filmmakers, the CEO says that medical device makers “have more power in this room than most governments around the world.”  End of excerpt.  As placed in the film, it sounds a wee bit sinister.  It is as if the documentary is trying to depict the CEO as a Bond villain.  Cue the terrifying henchmen, the white cat, the trap door, and the plan for world domination.  But context is all.  The speech was actually about the industry’s power to innovate.  Rather different, isn’t it?  Not that it makes a difference to the filmmakers.  After all, in more than one place in the film, the concept of innovation is belittled, even ridiculed. And yet, would anyone really prefer that the government stifle innovation?  We’ve read reviews of the film that conclude by advising viewers to question their doctors when innovative treatment is proposed.  It is good for patients to ask questions.  But it is not so good for them to be cynical.  Hello, vaccine-avoiders.  And it is not so good for patients or doctors to harbor preconceptions against innovation.  Later in the film, the AdvaMed representative submits to an interview by the filmmakers.  What he says is appropriate and above reproach.  But, again, something interesting happens with the editing.  After the AdvaMed rep answers the questions, the camera holds on him for an uncomfortable pause.  The fellow looks at the camera.  Then he looks around.  Then he lifts his paper cup of coffee.  Only after the camera plays its little trick of creating discomfort does it finally cut away. What is the purpose of that?  Whose bias is actually being exposed?  We are reminded of the scene in the Michael Moore movie where a government official is shown combing his hair before the interview.  Context can convey skepticism and derision.   

 

Needless to say, the film-makers employed no such editing maneuvers during the interviews of the plaintiff litigation team. 

 

Again, the film is effective at doing what it wants to do.  It makes a case.  But do not for a moment mistake it for what it is not – a balanced examination of the truth. 

 

[P.S.: Happy Birthday to the Drug and Device Law Son.  We will always be hopelessly biased in his favor.]