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Last week we bashed a Ninth Circuit Daubert decision.  We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the chorus of defense hacks who bemoan the Ninth Circuit’s supposedly liberal, pro-plaintiff bias. You see, we began our legal career out West and would still be there but for a simple twist of fate.

When we clerked for the great and good Circuit Judge William A. Norris in Los Angeles, we were in the Ninth Circuit. Norris possessed both high principles and brilliant technical reasoning.  He grew up in a western Pennsylvania Gold Star family, served in the military, graduated from Princeton U. and Stanford Law, clerked for Justice Douglas, became a preeminent litigator who would beat you whether the issues were constitutional, administrative, or commercial, ran Bobby Kennedy’s 1968 California Primary campaign that saw success turn into tragedy, founded a major museum of contemporary art, and became a judicial giant who produced brilliant opinions and a lineup of SCOTUS clerks.

Norris did not fret over the Ninth Circuit’s reputation for SCOTUS reversals.  He tried to get things right.  Sometimes that meant getting out ahead of SCOTUS, as with his Watkins decision, which anticipated equal protection of gay rights. Working with Judge Norris was a privilege.  If there is an ounce of value to our legal writing, then most of that ounce comes from sessions sitting next to Norris in front of a computer screen, editing opinions word by word.  He insisted that the writing be concise and powerful.  He would bark out in joy whenever we eliminated unnecessary words.  Clear writing came from clear thinking, and Norris’s lightning fast brain always took a logical path through complexity.

Norris passed away this last January, filling us with grief and leaving us feeling like a judicial orphan.  A few months before his death, Judge Norris completed his autobiography, Liberal Opinions: My Life in the Stream of History.  It is a remarkable and uplifting story. Norris carved out a sparkling career in the law.  He also offered splendid advice, including the need to go with one’s gut.  (But do not follow this advice if your gut is an idiot.) We were startled to see on page 188 a quote from this blog defending the Ninth Circuit’s reputation.  Judge Norris’s approval meant – means – a lot to us.

The Ninth Circuit is vast.  It contains multitudes.  When we took our first deposition in San Diego, in a case involving (so help us) stolen dirt, we were in the Ninth Circuit.  When we interviewed a witness in the FBI’s Honolulu office, we were in the Ninth Circuit. When we traveled with DCIS agents and postal inspectors to Las Vegas to round up a check-stealing ring, we were in the Ninth Circuit.  When we did a presentation on litigation and pop culture at the hotel that was the setting for the Twin Peaks television show and movie (Snoqualmie Falls, Washington) we were in the Ninth Circuit.  When we took home the Drug and Device Law Infants from Cedars Sinai Hospital in Beverly Hills, we were in the Ninth Circuit. So were we when we carried those kids on backpacks through Yosemite Valley and, later, hiked alongside them past Yellowstone’s geysers.   (Now we’re just getting sentimental.). Here’s the point: is it any wonder that the Ninth Circuit has, not just the most opinions of any Circuit, but the broadest range of issues and a sometimes perplexing array of outcomes?  Petulant calls to divide this magnificent Circuit, which contains one-fifth the country’s population, make no sense.  How to divide?  Create a California-only Circuit? That would be unprecedented.  Plus, we’d certainly get more Circuit splits.  What’s good about that? Why do we insist on dwelling in echo-chambers, occasionally stepping outside only to hurl invectives? The Ninth Circuit is a model, not a problem.

Which is not to say that the Ninth Circuit is free from mistakes.  We already mentioned Wendell.  Today, we are discussing a case that seems headed for the Supreme Court.  We do not know if it contains mistakes – it turns on a nice issue of first amendment law, and we know just enough about that area to know there are plenty of people out there who know more.  Retail Digital Network, LLC v. Prieto, 2017 WL 2562047 (9th Cir. en banc June 14, 2017), matters to us because it turns on an interpretation of the SCOTUS Sorrell decision from 2011.  We have blogged about Sorrell several times.  For example, check out this post.

Here is a brief Sorrell refresher.  Vermont passed a law preventing pharma retailers from accessing information about which physicians prescribe which drugs. Data miners, who gathered and disseminated such information, challenged the Vermont statutes as violating the first amendment.  SCOTUS struck the statute down.  Our favorite part of the decision is that “[s]peech in aid of pharmaceutical marketing … is a form of expression protected by the Free Speech clause of the First Amendment.”  The Sorrell court held that the Vermont statute disfavored marketing, that is, speech with a particular content, and disfavored specific speakers, namely pharmaceutical manufacturers. In arriving at its result, the Sorrell court did not exactly follow the dance-steps set out in the Central Hudson commercial speech test.  The Sorrell court referenced “heightened scrutiny,” which is different terminology from the “intermediate scrutiny” in Central Hudson.

So what?  What indeed. When we first discussed the Sorrell case, we wondered what the case meant for constitutional protection of truthful off-label communications.  We also wondered whether Sorrell had expanded protection of free speech beyond Central Hudson.

It is that latter question that the Ninth Circuit en banc panel confronted in Retail Digital Network.  That case involved regulation of the marketing of alcohol, not pharmaceuticals, but the animating principles are potentially important for both.  California law prohibits alcohol manufacturers and wholesalers from providing anything of value to retailers in exchange for advertising their products.  In a pre-Sorrell Ninth Circuit case called Actimedia, the Ninth Circuit had applied the Central Hudson test to uphold California’s law, holding that it directly advanced important state interests in separating alcohol manufacturing, wholesale, and retail interests, as well as the state’s interest in temperance. The district court felt bound by Actimedia, and upheld the statute.  The original Ninth Circuit panel in Retail Digital Network held that Sorrell had created a more demanding first amendment test, that, consequently, Actimedia was no longer good law, and that the district court needed to consider whether the California statute could survive Sorrell‘s  “heightened scrutiny.”  The en banc panel reversed the original panel’s reversal of the district court. (Got that?).

The en banc panel reasoned that Sorrell had not really changed the Central Hudson test in any substantive way.  The “heightened scrutiny” phrase was merely intended by SCOTUS to mean more heightened than rational basis review.  In other words, “heightened” equals “intermediate.”  Thus, Actimedia was still good law.  Mostly.  The Retail Digital Network en banc panel concluded that Actimedia was correct that the California statute advanced the state’s interest in separating manufacturing, wholesale, and retail players in the alcohol industry.  California has a legitimate interest in ensuring that advertising payments are not disguised forms of kickbacks and methods of securing vertical and horizontal integration harmful to consumers.  But the en banc panel no longer bought the proposition that restriction of payments for retail advertising would reduce overall  alcohol consumption.  At best, such a restriction might indirectly serve the temperance goal, and that does not cut it under Central Hudson.  Still, the California statute survives.

What to think about the Retail Digital Network opinion?  From our point of view, whether applying “heightened” or “intermediate” scrutiny, we think truthful off-label statements should be protected speech.  The term “promotion,” which seems meant to be pejorative, should not alter the analysis.  We’re not sure that the en banc opinion pays enough attention to the Sorrell discussion of content- and speaker-specific regulations. It’s perhaps too simplistic to say that all commercial speech is content- and speaker-specific. The FDA would be the first to say that it is regulating what manufacturers say, but not what doctors or researchers say.  Will SCOTUS reverse the en banc panel’s reversal of the original panel’s reversal of the district court’s strike-down of the statute?  (Got that?). Keep in mind that the Ninth Circuit en banc panel is joining the Second, Fourth, Sixth, and Eighth Circuits in holding that the Central Hudson test for commercial speech lingers beyond the Sorrell holding.  Moreover, the make-up of the Ninth Circuit panel (remember, Ninth Circuit en banc panels do not include all the active judges in the Circuit) is interesting.  The only dissenter was Chief Judge Thomas. (The Chief Judge is always on en banc panels).  All the other judges voted that Central Hudson still supplies the test.  Among those judges in the majority were Kozinski and Reinhardt. When those two judges, universally considered among the most brilliant judges from the conservative and liberal schools, respectively (yes, we know that is a vast simplification, but forgive us), agree on something, one should be slow to predict SCOTUS reversal.

Then again, Monday’s SCOTUS decision in Matal v. Tam, which struck down the rule against trademarks that disparage persons, might have something to say about Retail Digital Network.  Most commentators have discussed what the Matal case means for the Washington D.C. National Football League team.  But Matal also applied a very muscular version of the Central Hudson test in holding that the non-disparagement provision was not a sufficiently “narrowly drawn” means of advancing “a substantial interest.”  One such asserted substantial interest in Matal was the orderly flow of commerce.  That is not exactly the same interest sustained by the Ninth Circuit in Retail Digital Network, but it is pretty close.  Stay tuned.

Let’s start with a shameless plug: the author of this post, along with Sean Wajert (Shook Hardy & Bacon), will present a Strafford webinar on June 21 entitled, “Daubert/Frye Motions in Product Liability Litigation: Bringing or Defending Challenges to Expert Witness Evidence.”  Here is the link.  We will cover a lot of areas and a lot of cases.  Odds are good that the most recent case covered will be Wendell v. GlaxoSmithKline, LLC, 2017 WL 2381122 (9th Cir. June 2, 2017).  That’s too bad, because it is not a well-reasoned case.  It is a backwards step in Daubert analysis. For people who favor rigorous application of Daubert to keep junk science out of the courtroom, the Ninth Circuit’s Wendell decision is the worst sort, because it reverses a district court’s exclusion of expert opinions lacking support in epidemiology, animal studies or biologicals plausibility — meaning Wendell said it was an abuse of discretion for the district court to exclude the opinions.  That is the kind of precedent that can turn nervous judges from gatekeepers to matadors who grimly wave junk science along to the jury.

The plaintiffs in Wendell alleged that their son died because medicines used to treat inflammatory bowel disease (IBD) caused him to develop cancer.  The plaintiffs proffered two causation experts, but the district court found their opinions unreliable and, therefore, inadmissible under Federal Rule of Evidence 702.  The court subsequently granted summary judgment in favor of the defendants.  A key issue on appeal was the district court’s exclusion of the plaintiff experts’ opinions.  The district court had identified several problems with those opinions.  Here are some:

– The opinions were litigation-driven, were based on no independent research, and would not satisfy the standards for peer-reviewed journals.
– No animal or epidemiological studies showed a causal link.
– The studies cited by the experts did not show that the specific combination of drugs prescribed to the plaintiffs’ decedent actually caused the injury at issue.
– The experts did not present any scientific evidence excluding IBD itself as a risk factor for the injury.

The Ninth Circuit called it “a close question” in concluding that the district court erred in excluding the expert testimony. In the eyes of the appellate court, the litigation-driven, non-study-supported, non-alternate-cause-excluding nature of the expert opinions should not overcome the facts that the experts were “highly qualified doctors” who had performed a “differential diagnosis” in arriving at their opinions.  The Ninth Circuit’s analysis is unsatisfactory.  First, the qualifications of the experts is a different issue from reliability of their methodologies.  Under Rule 702, a qualified expert may testify if her testimony would be helpful to the jury, if she relied upon the appropriate facts/data, if she employed reliable methods, and if she reasonably applied those methods to the facts of the case.  That is, qualifications are a precursor to reliability, not a substitute for it.  If a Nobel prize winner renders an opinion based on astrology or phrenology, that opinion should be excluded no matter how impressed we are to be in the presence of such a luminary.  Second, the Ninth Circuit looks at each of the methodological problems identified by the district court one-by-one, and repeatedly holds that the deficiency by itself (e.g., lack of animal studies), cannot exclude expert testimony.  Maybe so, but when the opinions of an expert (no matter how well qualified) are beset by so many deficiencies, how can it be an abuse of discretion for a diligent district court to decide that the opinions do not pass muster?  In truth, the Ninth Circuit did not apply anything close to an abuse of discretion standard of review.  Rather, it engaged in a de novo review of the expert opinion issue, and did so in a remarkably wrong-headed fashion.  The results of this precedent could be seriously damaging.  If sparkling CV’s and invocations of “differential diagnosis” (and that’s not what was done by the experts by the way, but that’s a different point) can get causation opinions and a case to a jury, then Daubert has been diluted to the point of meaninglessness.

We will mimic the style of the great television critic Alan Sepinwall and end with some random observations:

– Along with two Ninth Circuit judges, the Wendell panel included a Vermont district judge who had authored an outlier opinion predicting that Vermont would adopt innovator liability.

– The Wendell opinion cites the Ferebee opinion from the D.C. Circuit.  Ferebee is seldom a harbinger of anything good for defendants.

– The Wendell opinion is sufficiently bad and problematic to merit en banc or Supreme Court reversal.

 

In the annals of history, June 6 gets prime billing.  That’s understandable, because the successful Normandy landings on D-Day (June 6, 1944), probably saved Western Civilization.  (Or maybe that heroic endeavor simply preserved liberal democracy for another 75 years, now that we seem encircled by fanatics both home and abroad who view the Enlightenment with disdain.)  But June 7 is no slacker.  On June 7, 1776, Richard Henry Lee introduced the Lee Resolution, which later became the Declaration of Independence. 364 days before D-Day, the American Navy decisively won the Battle of Midway, which turned the tide of the Pacific War.  On June 7, 1892, Homer Ferguson refused to leave the whites-only part of a train.  He later lost his Supreme Court case, Plessy v. Ferguson.  That opinion upheld “separate but equal,” a nasty judicial stain that would not be scrubbed away until 1954.  (SCOTUS Lesson #1: Horrible Supreme Court precedents can be overturned, but it can take a terribly long time – almost as long as the interval between NBA Finals games.)  One year later, on June 7, 1893, an Indian barrister offered a very similar refusal in South Africa.  That refusal is usually counted as Gandhi’s first act of civil disobedience.  And on June 7, 1965, the Supreme Court issued its decision in Griswold v. Connecticut, holding that married couples have a constitutional right to contraception.  Maybe there are people in 2017 who regret that decision (see our overly political parenthetical above) but we’d be surprised to meet such people, just as we’d be surprised to meet people who regret Brown v. Board of Education.  Still, the High Court arrived at that sensible result via a fuzzy analysis (e.g., “penumbras” and “emanations”) that could justify just about anything.  (SCOTUS Lesson #2: Good results and good reasoning do not always operate in tandem.)

In the passage of time, whether viewed as a Hegelian movement of ideas or as merely One Damned Thing After Another, June 7 is a significant date.  Now here comes the inevitable strained segue: today’s case, In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Product Litigation, 2017 U.S. Dist. LEXIS 82761 (S.D. Indiana May 31, 2017), is about the passage of time.  More specifically, it is about how statutes of repose apply in drug and device litigation.

We do not often get a chance to write about statutes of repose.  We get more opportunities to discuss statutes of limitations, though we infrequently seize those opportunities, because the issues are usually fact-specific and obvious.  By contrast, statutes of repose present interesting legal issues, and their force can be devastating to tardy claims.  In the In re Cook Medical case, the defendant made a motion on the pleadings to dismiss claims on the ground that they were precluded by statutes of repose.  The court wrestled with three different statutes of repose:  Georgia, Tennessee, and Texas.  The differences among those statutes resulted in different dispositions of the claims by the various IVC Filter plaintiffs’ claims.

Georgia

The Peach State bars claims for strict liability, negligence, or breach of warranty if the suit is not brought within ten years from the date of the first sale.  The Georgia plaintiffs’ claims in this case were filed more than ten years after the sale.  Buh-bye, right?  Not so fast.  Georgia’s statute of repose contains an exception if the defendant manufacturer engaged in conduct manifesting “willful, reckless, or wanton disregard for life or property.”  The plaintiffs argued that they had alleged such conduct.  How? it is not clear from the opinion.  Please excuse a slight rant.  It seems far too easy for drug and device plaintiffs to allege that any failure to warn equals reckless or wanton conduct.  Courts need to clamp down on this all-too-easy way to maintain settlement leverage or exploit jury anger.  Not adding a warning in the face of controversial or mixed studies should not be the stuff of punitive damages.  Maybe someday courts will wake up to this nonsensical hole in product liability law.  End of rant.  The In re Cook court was not such a court.  But it did limit the damage. It held that that the willful/reckless/wanton exception applied only to negligence claims, but not to strict liability and warranty claims.  Thus, the court dismissed the strict liability and warranty claims per the statute of repose.  The negligence claims remained.  So did the consumer fraud claim, which the court held was not subject to the statute of repose.

Tennessee

Tennessee also has a ten year statute of repose, though apparently not the willful/reckless/wanton exception.  At least no such exception was raised in this case.  The Tennessee plaintiffs conceded that the strict liability claims were doomed, but they tried to keep their negligence and warranty claims alive.  Nice try, said the court, but Tennessee’s Product Liability Act defines “product liability action” to include all of the plaintiffs’ claims.  That did not quite end the debate. The plaintiffs pointed out that Tennessee extended the statute of repose to 25 years for asbestos and silicone gel implant claims.  Why should those claims get such special treatment?  Never you mind, said the court, which applied the rational basis test and concluded that the Tennessee legislature was allowed to make such distinctions.  Sure, IVC Filters might pose risks of latency, but the constitution does not compel legislators to treat all latent defects the same.  Put another way, “[i]t is no requirement of equal protection that all evils of the same genus be eradicated or none at all.”  In re Cook Medical, IVC Filters Prods. Litig., 2017 U.S. Dist. LEXIS 82761 at *14, quoting other cases.  The court dismissed all of the Tennessee claims.

Texas

“T for Texas, T for Tennessee.”  Those two states go together musically (see Guy Clark, Willie & Waylon, Lynyrd Skynyrd, etc.).  Here, they also go together legally, as the defendant prevailed on the statutes of repose from both states.  The Texas statute of repose is for 15 years.  (Of course it is bigger.  This is Texas.)  But there is an exception if the manufacturer/seller explicitly warrants that the product has a useful life longer than 15 years. The Texas plaintiff attempted to save her claims by filing an affidavit, wherein she said she was told that the device was permanent, and the Patient Guide, which stated that the IVC Filter was “safe and effective as either a permanent or temporary device.”  But this was a motion on the pleadings.  Outside materials are not allowed.  Looking just at the complaint, there was no allegation that the IVC filters were marketed as permanent devices.  That is very, very bad for the plaintiff:  “As this is a motion for judgment on the pleadings, the omission of her specific warranty allegations is fatal.”  Id. at *18.  You might think that is an extraordinarily severe result.  No matter. The court observed that even if the allegations of permanence were included in the complaint, the claims would still not fly, because the plaintiff nowhere alleged any specific person who warranted permanence, and nowhere alleged any reliance on such warranty of permanence. As for the Patient Guide, the plaintiff did not allege in either her complaint or her affidavit that “she read the Guide before her surgery, much less that she relied on the Guide rather than her own doctor’s recommendation.”  Id. at *20.  Accordingly, the exception to Texas’s statute of repose did not apply, the statute of repose did apply, the claims were timed-out, and they had to be dismissed.

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

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

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

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

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

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

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

Discovery regarding expert witnesses can be tricky.  In our neck of the woods, the great Commonwealth of Pennsylvania, state courts almost never permit depositions of experts.  If you want to ask the expert questions – and you will – you must wait until trial.  The flip side of that restriction is that expert reports in Pennsylvania must really and truly and completely disclose the expert’s opinion.  If an expert at trial strays a millimeter past the four corners of the expert report, the court will shut such testimony down.  By contrast, in most court systems, including the federal system, discovery regarding expert witnesses is extensive, and the deposition of the other side’s expert is usually one of the most consequential moments in the litigation.

 

Mind you, we are talking about testifying experts.  Parties can retain experts who will testify at trial, but they can also retain experts who serve purely as consultants.  Those consulting experts work behind the scenes, furnishing facts and ideas.  They might, for example, help us prepare to depose the other side’s experts.  These consulting experts are usually not subjected to the discovery maw. 

 

But what if an expert transforms from consultant to testifier in the course of a litigation?  What and how much is discoverable?  That interesting scenario arose in In Re: Abilify (Aripiprazole) Prods. Liab. Litig.,  2017 U.S. Dist. LEXIS 73847 (N.D. Fla. May 15, 2017).  The plaintiff lawyers talked to an expert “informally,” then later retained him.  That expert had conducted research, resulting in an article, upon which the plaintiffs then relied.  The defendants sought to depose that expert about the article, including whether the plaintiff lawyers influenced the study.  The defense did not want the plaintiffs’ expert to point proudly to a peer reviewed study if the plaintiff lawyers had done as much reviewing as the peers.   

 

As you can imagine, the plaintiff lawyers resisted.  They argued that questions about the inputs into the article would have a chilling effect on scientific research.   The plaintiffs object to any discovery into communications between the expert and plaintiffs’ counsel because Fed. R. Civ. P. 26(b)(4)(D) protects informal consultation with experts: “Ordinarily, a party may not, by interrogatories or deposition discovery facts known or opinions held by an expert who has been retained or specially employed by another party in anticipation of litigation or to prepare for trial and who is not expected to be called as a witness at trial”  except on a “showing [of] exceptional circumstances under which it is impracticable for the party to obtain facts or opinions on the same subject by other means.”  The plaintiffs also objected because communications with the expert were protected opinion work product under Fed. R. Civ. P. 26(b)(3): the court “must protect against disclosure of mental impressions, conclusions, opinions, or legal theories of a party’s attorney or other representative concerning the litigation.”   

 

The court allowed some discovery, but within limits.  The court held that the defendants could question the expert about the plaintiffs’ influence on the study, as it is an aspect of bias.  Even if the influence occurred during the “informal” consultant period, it was fair game.  Thus, the defendants were permitted to inquire whether the expert “made any changes to the timing, methodology, or other relevant aspect of the study following communications with Plaintiffs’ counsel.”  Further, to the extent that the expert “initiated contact with Plaintiffs’ counsel, Defendants are free to inquire into his motive and the timing of such contact.”  But the court also held that the defendants could not inquire into work product (“regarding any opinions or case strategies shared by Plaintiffs’ counsel, or any other inquiries made by plaintiffs’ counsel that related to the preparation of their case”) unless the deposition established that the plaintiffs influenced the conduct of the study.  If evidence of the plaintiffs’ lawyers inputs into the study surfaces during the deposition, the parties would need to contact the Judge to determine whether a waiver of work product had taken place. 

 

This case is not really a ‘win’ for plaintiffs or defendants, because the court’s decision threads the needle fairly carefully, and because, considering the rule from an ex ante perspective, both plaintiffs and defendants might retain consulting experts who later become testifiers.  Rather, the case represents an unusual, but not impossible, situation where both sides must be especially careful.

 

 

We like bright lines in the law.  They streamline arguments for lawyers and, more important, they make it easier for non-lawyers to conduct their affairs with some degree of predictability.  Rear-end a car and you’re liable, even if the other guy stopped short.  Leave a sponge behind in a patient’s abdomen, and you and your operative team are on the hook.  The thing speaks for itself, and the thing it speaks is very bad for your defense case.  Utter a negative statement about someone in a courtroom, and you’re immune from libel liability.  Say the same thing on the courthouse steps, and you might be in trouble.  Sell a pharmaceutical product with a federally approved label, and when someone sues you for failure to warn you’re … uh oh. Thanks to the Supreme Court’s opinion in Wyeth v. Levine, you’re still in the soup if you could have added warnings via the Changes Being Effected (CBE) provision.  You might not like that rule, but at least it’s clear, right?  Wrong.  Recent opinions have come out on opposite sides as to what would constitute “clear evidence” that the FDA would have rejected an additional warning, or even who gets to decide that ‘fact.’

 
But at least we know that the CBE provision is available only in certain circumstances, right?  Thanks to the recent case of Blackburn v. Shire US, Inc., 2017 WL 1833524 (N.D. Alabama May 8, 2017), even that inquiry is muddy.  The plaintiff in Blackburn alleged that he contracted kidney diseases from a drug known as LIALDA.  Please forgive us for thinking that the failure to warn claim is a straight loser, since the LIALDA warned of precisely the injuries suffered by the plaintiff.  That would be a nice example of a bright line rule.  The defendant filed a motion to dismiss the entire First Amended Complaint.  That motion to dismiss was strongly supported by the Wyeth v. Levine “clear evidence” standard.  Or at least it should have been.  The motion to dismiss was also strongly supported by the Pliva/Bartlett independence/impossibility principle.  Or at least it should have been.  The Blackburn court granted the motion to dismiss only in part, and it is hard to characterize the court’s reasoning as anything but disappointing.
 
The plaintiff argued that the label was defective because it merely recommended “periodic” evaluations for possible kidney damage.  The plaintiff argued that “periodic” was too vague.  According to the plaintiff, “periodic” might mean semi-monthly or annual.  According to the plaintiff, the LIALDA label should have suggested evaluations every month for the first three months after therapy, then on a quarterly basis for at least one year.  The court bought the plaintiff’s argument, which amounts to a duty to tell doctors how to practice medicine.  Technicality and a belief in the vicissitudes of juror deliberations triumph over common sense. This ruling is further proof that no matter what a warning label says, a clever plaintiff lawyer and a cautious court can always conjure up an ‘improvement’ to a product label and thereby keep a weak case on the docket.
 
Even assuming that “every month for a while, then quarterly” would be an improvement, or even a distinction with a difference vs. “periodic,” the defendant had a pretty good argument in support of preemption. The CBE supplementation process applies only when “newly acquired information” becomes available and would support the label change that the plaintiff wants.  Prior to the LIALDA label, there was already information regarding the sort of testing protocol argued for by the plaintiff.  That’s not just how we defense hacks parse the record.  The plaintiff admitted “that evidence of the renal toxicity of LIALDA and his proposed testing regimen existed prior to LIALDA’s FDA approval.”  Blackburn, 2017 WL 1833524 at *4. That pre-existing information environment should support preemption.  Shouldn’t it?  No, said the court, because there was additional evidence about testing after the label went into effect.  Such incremental evidence could have had a cumulative effect, and that effect could constitute “newly acquired information.”  Ugh.  How much more is enough to make a difference?  Is mere repetition enough?  Who knows?  So we have a label that warned of the injury suffered, advised periodic testing, and even if it didn’t specify the period as much as the plaintiff would like, there was already pre-label information about such testing.  Maybe the only bright line the court favors is one against preemption.
 
The plaintiff’s proposed change faced another preemption barrier.  The change would seem to apply both to the “Full Prescribing Information” section in the label and the “Highlights” section.  The regulations (21 C.F.R. §314.70(b)(2)(v)(C), to be specific) do not permit a drug manufacturer to change the Highlights section without FDA approval.  That would be a “major change.”  The plaintiff argued that the FDA might have approved a change in the Highlights section, but that sort of speculation is foreclosed by the Pliva/Bartlett independence/impossibility principle.  If a manufacturer cannot take unilateral action, a lawsuit insisting on such action is preempted, and even this cautious court agreed that any change to the Highlights section would be preempted.  The “periodic” language criticized by the plaintiff appeared in both the Highlights section as well as the body of the label.  Is it possible to demand change in one without demanding the same for the other?  The Blackburn court was not sure, but gave the plaintiff the benefit of the doubt.  The plaintiff might be going forward on “shaky ground” (2017 WL 1833524 at *7), but the court permitted the plaintiff to proceed under the highly fictional notion that the term “periodic” in the Highlight section is okay so long as the body of the label supplies a “mere clarification” of what “periodic” means.  So the elaboration of “periodic” to mean a particular testing regimen manages to be both crucial and perfunctory at the same time.  
 
Even aside from preemption, the learned intermediary doctrine should have barred the plaintiff’s failure to warn claim.  There was no allegation that the treating doctor would have prescribed a different treatment.  It is not even clear that there was a specific, plausible allegation that the doctor would have done anything different.  If preemption is Scylla and the learned intermediary doctrine is Charybdis, how did the plaintiff evade both?  The court thought it sufficient that the plaintiff alleged that the treating doctor was a gastroenterologist, and that he probably missed the nephrology literature that expounded on the preferred testing regimen.  Thus, the First Amended Complaint offered sheer speculation that the treating doctor would have implemented a different testing regimen if only the label had informed him of as much.  But, did the treater read beyond the Highlights?  That treating doctor’s deposition will turn out to be quite important, though the court’s roadmap promises a bumpy trip, filled with blind alleys and detours.
 
Not everything the Blackburn court did was dismal.  The court dismissed the express warranty claim because the LIALDA label cannot be construed as “an express warranty of safeness.”  Id. at *9.  What the label did say was that LIALDA was safe to treat the illness at issue, and that the medicine presented a risk of precisely the injury suffered.   How can there be a breach of warranty?  At this point, we are nodding our head in agreement, quickly followed by shaking it in puzzlement over how this rationale does not equally apply to the failure to warn claim.  The court also dismissed the fraud claims because there was no misstatement of a material fact.  Rather, the plaintiff alleged only deficiencies with the label’s recommendation for testing.  We certainly agree that the alleged deficiency is not material, but then wonder how that same immateriality permitted the plaintiff to circumvent both preemption and the learned intermediary doctrine.   

May 10 is an important day in the history of the law.  On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit.  The case was called Nix v. Hedden, 149 U.S. 304 (1893).  The issue concerned application of the Tariff Act of 1883, which imposed a tax on vegetables, but not fruits.  The appellant was one of New York City’s biggest produce sellers.  He imported lots of tomatoes, and was looking to dodge the tax.  He cited dictionaries defining tomatoes, in a technical/botanical sense, as the “’fruit’ as the seed of plants, or that part of plants which contains the seed, and especially the juicy, pulpy products of certain plants, covering and containing the seed.”  But, alas, the High Court ruled that “[t]hese definitions have no tendency to show that tomatoes are ‘fruit,’ as distinguished from ‘vegetables,’ in common speech, or within the meaning of the tariff act.”  Science be damned, people eat tomatoes in their salads, not desserts, so they are vegetables, not fruits.  Because common parlance prevailed, the taxpayer did not.

 

*                    *                    *                    *                    *

 

We’ll exploit this historical legal oddity and its exaltation of common understanding as a semi-ironic preface to a case where a pro se plaintiff went down in flames in a product liability case.  In Coleson v. Janssen Pharmaceutical, Inc., et al., , 2017 U.S. Dist. LEXIS 68072 (S.D.N.Y. May 3, 2017), the plaintiff filed a pro se complaint against the defendants in New York state court (the Bronx, to be specific) , which alleged that he developed gynecomastia as a result of taking Risperdal and generic risperidone. The defendants removed the suit to federal court.  Things were already heading in the right direction for the defense.  After discovery, during which the plaintiff apparently never found an expert on causation, the defendants moved for summary judgment.  The defendants won.  The plaintiff lost.  Common sense also won: the court rejected innovator liability for an alleged failure to warn by a generic competitor.  Finally, we are reminded of that most common of courts, The People’s Court, where Judge Wapner routinely blasted plaintiffs for not having the requisite paperwork to back up their claims. 

 

After the plaintiff in Coleson had been diagnosed with bipolar schizophrenia around 2009 or 2010, physicians prescribed Risperdal and risperidone. Risperdal is the brand name product and was manufactured/sold by the defendants.  Since at least 1996, Risperdal’s FDA-approved disclosures stated that Risperdal is associated with endocrine-related side-effects, including gynecomastia.   Risperidone is the generic version.  It had been available since 2008.  Medicaid paid for all of the plaintiff’s prescriptions. New York’s Medicaid program excludes coverage of brand-name drugs when there is an FDA-approved generic equivalent on the market unless one’s healthcare provider specifically requests an exemption for the patient.  So it looks as if the plaintiff was probably taking risperidone.  That is, he took risperidone until sometime in 2013-14, when he switched to an entirely different atypical antipsychotic, which was also associated with gynecomastia.  The plaintiff was diagnosed with gynecomastia in 2015. 

 

Despite his usage of generic risperidone and a different antipsychotic, the plaintiff sued only the Risperdal brand manufacturer.  As with most pro se complaints, the theories of the case were less than pellucid.  The defendants and the court construed the causes of action as failure to warn and design defect against the brand manufacturers.  The plaintiff alleged that the side-effect information in the generic risperidone was different from the FDA-approved Risperdal label.  The defendants’ summary judgment motion argued that the plaintiff’s claims failed for lack of any evidence that the plaintiff ingested name-brand Risperdal, as opposed to generic risperdone. The defendants argued that they could not be held liable for either failure to warn or design defect for an injury resulting from a product that they did not manufacture, distribute, or sell. The defendants also argued that the plaintiff could not show medical causation between Risperdal and his gynecomastia.

 

Yes, we are confronted yet again with the issue of innovator liability.  Under Erie, the federal court needed to determine the substantive law of the forum, New York.  The New York Court of Appeals has not yet addressed whether a manufacturer of a name-brand prescription drug can be held liable for injuries resulting from another company’s generic equivalent. But there is at least one federal case, Goldych v. Eli Lilly & Co., No. 04 Civ. 1477 (GLS)(GJD), 2006 WL 2038436 (N.D.N.Y. July 19, 2006), and one New York state case, Weese v. Pfizer, Inc., 2013 N.Y. Misc. LEXIS 4761, 2013 N.Y. Slip Op. 32563 (Sup. Ct., N.Y. Cty. Oct. 8, 2013), rejecting innovator liability.  Those two New York decisions are in accord with the majority of courts to consider the topic: fifty-five other state courts across twenty-one states, in addition to all six circuit courts of appeal, have ruled that innovator liability makes no sense.  See our general innovator liability posts here and here. The Conte decision in California, which applied such innovator liability, stands as an egregious, eccentric exception.   The Coleson court acknowledged that there are a couple of cases clumsily following Conte, but the Coleson court declined to join the heresy.

 

Supporting its decision, the Coleson court discussed a recent asbestos case that, at first blush (but only first blush) seemed to offer some hope for the plaintiff.   Last year, in In re N.Y. City Asbestos Litig., 27 N.Y.3d 765, 59 N.E.3d 458 (2016), the New York Court of Appeals held that manufacturers had a duty to warn of potential dangers resulting from their products’ use in conjunction with third party products. To support this interpretation, the asbestos court observed that the manufacturers had “knowledge and ability to warn of the dangers” when consumers used the product with a third party’s product. As we discussed at the time, here, that is quite a bit different from being required to warn about use of a competitor’s product, when the defendant’s own product was not being used at all.  The Coleson court reasoned that the asbestos ruling was unlikely to make “the cost of liability and litigation . . . unreasonable”  and, moreover, the manufacturers “derive[d] a benefit from the sale of the [other party’s] product.” This rationale weighed in the opposite direction in Coleson. The brand defendants “had no oversight in the manufacturing of the generic drugs. They earned no profit from the sale of the generic drugs. Given the length of time generic drugs can sell following a patent’s expiration, to find a new duty would unforeseeably expand the cost of liability on brand-name drug manufacturers.”  Coleson, 2017 U.S. Dist. LEXIS 68072 at *10.  

 

Goodbye failure to warn claim.  The plaintiff’s failure to warn claim was dismissed because he alleged a warning defect as to only risperdone, over which the defendants had no duty of care.

 

The Coleson plaintiff’s design defect claim also failed.  He could not show by a preponderance of the evidence that he ever ingested name-brand Risperdal. The plaintiff’s declaration and deposition stated that he was prescribed, amongst other drugs, “Risperdal (risperidone)” and that a hospital in 2009 or 2010 dispensed “Risperdal and/or risperidone.” The plaintiff also claimed that hospital records proving he actually received Risperdal in the hospital were likely destroyed by a fire in January 2015. [We know some especially nettlesome plaintiff lawyers who would turn this misfortune into a spoliation claim, but the pro se plaintiff lacked either the expertise or chutzpah to pursue that vexatious path.] It was true that the plaintiff’s medical records at times recorded his prescription as only for Risperdal.  But generic risperidone is regularly written as “Risperdal (risperidone),” a nomenclature even the plaintiff repeatedly adopted in his papers.  That a drug is prescribed under its brand-name does not mean that a patient receives that name-brand drug, and it is hardly justifiable to infer that it does. In the absence of real evidence, the Coleson court was unimpressed by the plaintiff’s “mere speculation or conjecture” as to Risperdal usage.  Coleson, 2017 U.S. LEXIS 68072 at *11.

 

But let’s for the moment speculate that a “fair-minded jury” could speculate that the plaintiff was prescribed brand name Risperdal somewhere in the relevant time-frame. And yet it was undisputed that by 2009, when the plaintiff was first prescribed the medicine, risperidone was a widely available generic to Risperdal. It was also undisputed that all of the plaintiff’s prescriptions were paid by Medicaid.  Aside from exceptional circumstances the plaintiff never showed, the plaintiff’s prescriptions under Medicaid needed to be filled with generic drug equivalents. Thus, from the evidence presented, no jury could draw the “justifiable inference” that the plaintiff received name-brand Risperdal for his prescriptions. There might well have been an inference of injury from ingestion of risperdone, but the Coleson plaintiff had not sued the generic manufacturer.  Id. at *12.

 

Even assuming that the plaintiff had ingested Risperdal, his design defect claim against the defendants would still fail because he could not establish that Risperdal caused his gynecomastia. The Coleson court embraced the requirement in products liability cases that, to establish causation, plaintiffs must offer admissible expert testimony regarding both general and specific causation. The requirement is particularly pertinent where a causal link is beyond the knowledge or expertise of a lay jury.  In the Coleson case, there was no such expert in sight. Id. at *13.   

 

The plaintiff suggested he did not need an expert on causation when he had something even better:  the Risperdal label.  That label contains a warning regarding gynecomastia.  The plaintiff also pointed to a  July 2015 medical report, which concluded that the plaintiff’s gynecomastia “is related to phychiatric [sic] medical ingestion.”  The court did not buy either of these arguments.  First, Risperdal’s warning label cannot establish general causation: “Product warning labels can have over-inclusive information on them, often out of ‘an abundance of causation or the avoidance of lawsuits.’  Coleson, 2017 U.S. Dist. LEXIS 68072 at *14 (quoting In re Mirena IUD Prods. Liab. Litig., , 202 F. Supp. 3d  304, 323 (S.D.N.Y. 2016)).  Unless a warning label specifically says that an alleged injury can be caused by a drug, courts have held that a drug’s product warning label alone cannot “raise a genuine issue of material fact with respect to general causation.”  Id. Risperdal’s label states merely that it “elevates prolactin levels” and that “gynecomastia . . . ha[s] been reported in patients receiving prolactin elevating compounds.” This information is not the same as an admission of “a genuine phenomenon” creating a “material fact with respect to general causation.”

 

Nor did the Coleson plaintiff’s July 2015 medical report establish proximate cause. The plaintiff claimed to have taken Risperdal around only 2009-10. Throughout 2010 to 2014, the plaintiff took risperidone. In early 2014, the plaintiff switched to a different antipsychotic, which is also associated with cases of gynecomastia. The plaintiff was diagnosed with gynecomastia only in early 2015, and the medical report to which the plaintiff points indicates the plaintiff had taken both risperidone and the other antipsychotic. This report does not state which, if any, of these drugs was responsible for the plaintiff’s injury. Without competent medical expert testimony on the issue of causation, a jury would be left only to “theorize” as to how the plaintiff came to suffer from gynecomastia. Id. Accordingly, the defendants’ motion for summary judgment was granted.

 

So what we have here is a good result from a smart court.  That decision was made a bit easier because a pro se plaintiff sued the wrong party, hired no expert who would render some frail opinion on ‘substantial causative factor,’’ and failed to assemble decent evidence of usage.  What’s that saying about someone who acts as his own lawyer?

 

 

‘Pointing to the empty chair’ is a well-known defense trial tactic.  It allows the defendant to go on offense.  Maybe the plaintiff deserves some compensation, so the narrative goes, but the plaintiffs sued the wrong party.  If the jury believes that narrative, it might exonerate the defendant completely.  Or it might at least assign some percentage of fault elsewhere and reduce the damage award.

 

Playing the blame game can be a way of redirecting jury anger.  It can also be tricky.  Is pointing to the empty chair inconsistent with major defense themes?  If you’re saying that an injury is not real, or not so bad, or was caused by something completely different, can you also say that non-party X should be on the hook?  The great Texas trial lawyer Racehorse Haynes died last week.  He won some trials that nobody thought were winnable.  He famously told a story about how he would defend a dog-bite case:

 

Say you sue me because you say my dog bit you. Well, now this is my defense:

My dog doesn’t bite.

And second, in the alternative, my dog was tied up that night.

And third, I don’t believe you really got bit.

And fourth, I don’t have a dog.

 

Of course, a little too much of that alternative pleading and the jury might start to doubt the lawyer’s credibility.  Here, we are talking about a slightly different defense:  some other dog bit you.  That other dog might be a health care practitioner.  But, as is often the case, doctors sometimes get special, favorable treatment from the judicial system.  In some jurisdictions, a defendant cannot point to a non-party doctor at all, or can do so only by making out a prima facie case of medical malpractice, complete with an expert opinion.  (At this point we are not even getting into the fact that many of our clients do not ever want to point the finger at a doctor, whether that doctor is a co-defendant or is a non-occupant of the empty chair.  Granted, the latter is much easier conceptually if not practically.) 

 

The toughest version of the empty chair defense is trying to pin blame on an actor that enjoys some degree of immunity.  That is what happened in the eccentric case of In re New England Compounding Pharmacy, Inc., Prods. Liab. Litigation, 2017 WL 1458192 (D. Mass. April 24, 2017).  The plaintiffs alleged that contaminated compounded drugs hurt a lot of people.  The main defendant  went bankrupt, so the plaintiffs went about suing all manner of unusual defendants on unusual theories.  A couple of relatively minor defendants asserted the comparative fault of the FDA, the Massachusetts Board of Pharmacy (“MBOP”), and some Tennessee governmental entities.  The Plaintiffs’ Steering Committee (“PSC”) moved for judgment on the pleadings against those defendants.  They won a little and lost a little.  The bit they lost is fascinating and prompts us to speculate on all sorts of outlandish possibilities. 

 

But first to the part the PSC won.  The Tennessee public duty doctrine shields public employees from suits for injuries caused by the breach of a duty owed to the public at large.  A duty owed to everyone turns out to be a duty owed to no one.  The public duty doctrine renders the public actors immune from duty and immune from fault.  Therefore, there can be no comparative fault laid at the door of such public actors.  Of course there is an exception to the rule of non-liability.  It seems there are always exceptions to non-liability rules.  That exception is triggered when the public employee owes a “special duty” to the plaintiff.  Such a special duty arises when, (1) the public employee undertakes to protect the plaintiff, and the plaintiff relies upon such undertaking, (2) a statute specifically creates a cause of action against an official or municipality for injuries resulting to a particular class of individuals, of which the plaintiff is a member, from failure to enforce certain laws, or (3) the public employee acted intentionally, maliciously, or recklessly.  The defendants in this case did not even allege that the Tennessee entities fit into these categories, so those Tennessee entities cannot be the focus of a comparative fault defense.

 

Goodbye Tennessee entities.  Any hopes of dragging them into the case via comparative fault “rode away on a Tennessee stud.”

 

By contrast, the defendants did allege that the FDA and the MBOP acted recklessly.  The defendants alleged that the FDA and MBOP were aware long ago that the compounder had sterility and potency issues, but failed to take any “meaningful, substantive action.”  The FDA had issued a warning letter to the compounder but, according to the defendants, never followed up appropriately.  Viewing the defendants’ allegations in the light most favorable to them, the court concluded that the comparative fault defense lived to fight on in the case.  Perhaps it will be tested again. 

 

Meanwhile, one cannot help but wonder how an FDA comparative fault defense might play out in future cases.  Many drug or device defendants face the issue of how much to highlight the fact of federal regulation in defending against liability.  It seems a worthwhile point to make, if only to let the jury know that companies cannot unleash products on the populace without some sort of review, clearance, and/or approval from the FDA.  We know of one court that has held that a 510(k) clearance is so meaningless as to merit preclusion from trial, but that opinion seems to be an outlier.  More often, the decision for the defendant is whether the fact of FDA regulation is worth the inevitable onslaught from plaintiffs and their experts about how the FDA is allegedly a paper tiger.   But now that we have read the New England Compounding case, we wonder whether that plaintiff onslaught potentially sets up a comparative fault defense — that the FDA acted recklessly in not initiating stricter enforcement action.  That would be a weird and risky position for a defendant to take.  But if the plaintiffs are doing everything they can to make the case, why not take advantage of it?  Still, there are wrinkles everywhere in such a scenario.  The Food, Drug and Cosmetics Act affords the FDA with discretion.  See 21 U.S.C. §336 (“Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution . . . whenever he believes that the public interest will be adequately served by a suitable written notice or warning”). Such discretion might protect the FDA from suit under the Federal Tort Claims Act.  It might even preempt this kind of argument. We don’t know, because we haven’t seen it before.  Even aside from that legal impediment, given FDA discretion, the concept of a common-law duty owed to any person to enforce the law in a particular way would seem to be a challenging argument.  As to the Massachusetts regulators, the comparative fault theory is intriguing as an empty chair defense, but what if someone tries to fill that empty chair with an actual state entity defendant?  Could parties in one state sue the regulatory bodies of another state for negligence concerning damages caused by a regulated product sold in interstate commerce?  The 11th amendment would seem to be an insuperable barrier, at least in federal court such as this MDL.    

 

Sometimes, weird little one-off rulings in unusual cases do not end up being so one-off.   

 

 

 

Plaintiff lawyers must be mighty allergic to federal court.  They perform all sorts of maneuvers to avoid CAFA removal of mass actions.  For example, they will artificially subdivide their cases into groups of under 100.  And/or they will disclaim any intent to try the cases together.  Do these circumventions work?  Perhaps most important, since so many of these CAFA avoidances occur in California, will such circumventions work in the Ninth Circuit?

Maybe.

At first, the Ninth Circuit permitted these evasions in a couple of decisions, creating a split with the Seventh and Eighth Circuits.  But then the Ninth Circuit took the cases up en banc.  The Ninth Circuit is so large that an en banc panel does not include all of the judges.  But an entire en banc panel always includes the Chief Judge.  That turned out to be important in the 2014 Corber en banc case because the dissenter in one of the earlier panel decisions was Chief Judge Gould.  Guess who authored the Corber en banc opinion?  Chief Judge Gould took a pragmatic approach to what counts as a “joint trial” for purposes of CAFA. That approach put the Ninth Circuit in alignment with the Seventh and Eighth Circuits and concluded that a proposal for a joint trial may be made implicitly as well as explicitly. Yes, it would be simpler to administer a bright line rule requiring plaintiffs to utter the magic words “joint trial,” but such a rule “would ignore the real substance” of plaintiffs’ proposals.  The plaintiffs had sought coordination “for all purposes.”  They had argued in the California state court that coordination was needed to avoid “the danger of inconsistent judgments and conflicting determinations of liability.”  That smells like a request for something that would actually or functionally be a joint trial.  The Ninth Circuit held that CAFA removal was proper under such circumstances.

Goodbye circuit split, hello sanity.  We praised the Corber decision here.

But the Corber opinion possibly suggested a road map — or another set of magic words — that might work to make federal jurisdiction disappear.   What if plaintiffs explicitly limited their request for coordination “solely for pretrial purposes”?  We all know that such a statement would be disingenuous.  But would it work?  Would it keep the cases in the pro-plaintiff maw of California’s coordination process?

The other shoe has fallen (sort of), the magic words have been uttered (sort of), and plaintiffs followed the road map (sort of). In Dunson et al. v. Cordis Corp., 2017 U.S. App. LEXIS 6446 (9th Cir. April 14, 2017), the Ninth Circuit upheld a remand of a mass action because the plaintiffs had not proposed a joint trial. (We have written about the Dunson case before.) Instead, the plaintiffs had argued that consolidation “for purposes of pretrial discovery and proceedings, along with the formation of a bellwether-trial process, will avoid unnecessary duplication of evidence and procedures in all of the actions, avoid the risk of inconsistent adjudication, and avoid many of the same witnesses testifying on common issues in all actions, as well as promote judicial economy and convenience.” We think this should be enough for CAFA removal, but the Dunson court held otherwise.

As an initial matter, the court says the appeal would be easy to resolve if the plaintiffs had simply sought consideration for “all pretrial purposes, including discovery and other proceedings,” and stopped there.  The Dunson court would easily have held that there was no request for a joint trial and thus, no basis for CAFA jurisdiction.  But the plaintiffs did not stop there.  They went on to wax poetically about the virtues of a bellwether trial process.  Do we now have a request for a joint trial?

The Dunson court held that it all came down to what sort of bellwether trial was being sought.  Sometimes, rarely, the result of a bellwether trial will be binding on the other cases. (For the moment, we are using deliberately vague language on this point.  More to come.) That definitely would meet the definition of a joint trial.  If that is what the plaintiffs want, they must go to federal court.  But much more typical is a bellwether trial  that would not be binding, but would be merely illustrative.   Such a bellwether trial, according to the Dunson court, would not be a joint trial and would not support CAFA jurisdiction.  The Dunson court assumes that when plaintiffs ask for a bellwether trial, they are asking for the non-binding member of the species.  Putting the burden on the defendant to show that the plaintiffs were proposing a joint trial, the Dunson court held that such a showing had not been made, that the plaintiffs had not sought coordination “for all purposes” as in Corber, and that, thus, remand to state court was appropriate.  A dismal day for the defense.  (The Dunson court supported some of its reasoning by citing another less-than-delightful Ninth Circuit case, Briggs, which we dissected here.)

There are many problems with the Dunson decision, including its departure from the pragmatic approach of Corber.   Experienced defense counsel know precisely what the plaintiffs want. They want a process that permits asymmetrical discovery where the defendants have to cough up millions of pages and scores of company witness depositions, while most of the plaintiffs’ individual cases hardly get tested.  That is, plaintiffs want a settlement machine.  The Dunson court pooh-poohed the preclusive effect of a bellwether trial because it would not have such effect on other plaintiffs.  But the Dunson court was forced to acknowledge that, “True, a verdict favorable to the plaintiff in the bellwether trial might be binding on the defendant under ordinary principles of issue preclusion, but that is not enough” (emphasis in original). How fair is that?  Moreover, the Dunson court ignores the plaintiffs’ own admissions of what they were up to in their consolidation request.  The plaintiffs wanted to avoid the risk of “inconsistent adjudications” (we bet the plaintiffs are pretty selective when it comes to that aversion) and they defined that risk as “different results tried before different judge and jury, etc.” The Dunson court admitted that such language “does suggest that a joint trial would be needed to avoid the risk of inconsistent adjudication.”  Yes. Yes, it does.  But the plaintiffs parked that language in a portion of their briefs generally extolling the wonders of consolidation (and overlooking the massive prejudice to defendants that can arise from consolidation), and the plaintiffs did, after all, remember to insert a disclaimer that they were not seeking a joint trial.

Look, we clerked on the Ninth Circuit and will defend it against all the usual ideological attacks.  But this time, the Ninth Circuit got CAFA removal wrong.  It ignored the Supreme Court’s admonition in Standard Fire Ins. Co. v. Knowles — a case nowhere even cited in Dunson — not to “exalt form over substance” in assessing CAFA jurisdiction.  Perhaps another en banc decision will ride to the rescue.

 

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn.  Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff of evidence that anything went wrong on the production line?  Seldom do we see the pharma equivalent of a mouse in the Coke bottle or, thinking of a more recent case, a bat in the salad.  Similarly, a design defect claim is often a make-weight claim.  How should the design have been improved?  Not selling the product at all is hardly a design improvement.  An entirely different product is not a safer alternative under the law of any enlightened state.  Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).  No, failure to warn is where the action is.  In the wake of Wyeth v. Levine, it seemed that preemption would be a tough row to hoe in such cases, but keep hoeing that row because the preemption defense might still be available – as a motion to dismiss, summary judgment motion, directed verdict, or argument to the jury.

 

The recent case of Amos v. Biogen Idec, Inc. et al., 2017 WL 1316968 (W.D.N.Y. April 10, 2017), makes every one of these points for us.  The court granted summary judgment to the defendants in that case, holding that all of the claims were fundamentally about failure to warn, the warning was adequate as a matter of law, and the FDA’s earlier rejection of proposed warnings meant that the plaintiff’s claims were preempted.  The facts of Amos present the sort of situation defendants encounter all too often, but which make for a hard sell to a jury: something very sad happened to an innocent patient, but it was nobody’s fault.  The patient had Multiple Sclerosis too severe to respond well to the usual treatments.  Her doctor recommended Tysabri.  That medicine came with a black box warning that it might increase the risk of Progressive Multifocal Leukoencephalopathy (“PML”), a viral infection of the brain that is as incurable as MS is.  The patient eventually contracted PML and died.  Her estate filed a lawsuit that included claims for negligence, negligent misrepresentation, strict liability, and breach of implied warranty. 

 

From the recital of facts in the Amos case, it appears that the manufacturer of Tysabri was quite diligent and proactive.  It also appears that the defense attorneys did an excellent job of mining the administrative record.  The manufacturer continued to perform clinical trials after initial approval, and promptly alerted the FDA of whatever risks it observed.  Among other things, the company asked the FDA to add information in the label about screening for certain virus antibodies that might increase the risk of PML.  The FDA rejected this proposal a couple of times, finding insufficient evidence at those times to support the label change.  The FDA ultimately relented and approved a label change in 2012 – after the plaintiff’s decedent died.

 

In considering the defense motion for summary judgment, the court concluded that all of the plaintiff’s claims turned on the sufficiency of the warnings.  New York law applied, and there was ample precedent under New York law that adequate warnings precluded claims for negligence, strict liability, breach of warranties, or fraud.  What’s more, the learned intermediary applied to claims regarding prescription drug warnings, and the record was replete with evidence that the prescribing doctor was well aware of the increased risk of  PMI.  It certainly helped the defense that the defendant, in collaboration with the FDA, had created a program called Tysabri Outreach: Unified Commitment to Health (“TOUCH”), which required that, prior to prescribing Tysabri, a physician had to acknowledge in writing that he/she understood the risks of PML and obtained a written acknowledgment from the patient that the patient understands the PML risk. The existence of the TOUCH program was one of several facts that made Amos a hard case for the plaintiff to win.

 

Even so, we all know that no matter how comprehensive and informative a warning label is, a good plaintiff lawyer can flyspeck it and find, or make up, some gaps.  The plaintiff lawyers in the Amos case are well known to us, and are very, very good.  They argued that the Tysabri warnings were inadequate because they failed to include information regarding the correlation between the virus antibodies and PML, and failed to inform doctors of the risks associated with duration of treatment and prior treatment with an immunosuppressant.  To our eyes, the plaintiff lawyers made the best arguments they could.  In too many courts, such an argument would furnish enough of a crutch for a plaintiff-leaning (or lazy-leaning) judge to mutter ‘factual dispute’ and deny the motion in a post-card ruling.  But not this court.  The judge analyzed New York law and held that even without the details regarding specific risk factors, “when read as a whole, the warnings unmistakably conveyed the seriousness of PML and its association with Tysabri treatment.”  That “read as a whole” point is important.  Do not let a court tell you that it is the jury’s duty to read the warnings as a whole.  It is the court’s job to assess whether the warning is adequate as a matter of law, and plaintiff post hoc fly-specking should not be enough to plant a case in front of twelve citizens good and true (and half-asleep and inflamed with sympathy and anti-corporate hatred).    

 

Even aside from the conclusion that the Tysabri warnings were adequate as a matter of law, the court offered an alternative basis for dismissing the case:  the claims were preempted as a matter of law.  Wyeth v. Levine ruled against preemption on the (at least partially specious) ground that drug companies can unilaterally ramp up warnings through the Changes Being Effected (“CBE”) process.  But the Amos court accurately observed that CBE is not available in all situations, and definitely is not available to add or change a black box warning, which is what was at issue in this Tysabri case.  Moreover, “the evidence of record leads inescapably to the conclusion that the FDA would not have approved a change to Tysabri’s label prior to 2012.”  With respect to Tysabri, there were two “smoking gun” rejections from the FDA. 

 

Also notable in Amos:  a second defendant in the case, a distributor of Tysabri, received summary judgment on preemption grounds.  The distributor did not own the drug’s New Drug Application, and thus had no power under the FDA scheme to alter warnings in any way.  The distributor’s inability to act independently to change warnings meant that, under the Mensing and Bartlett decisions, all claims against it were preempted.

 

There have been other cases around the country where courts arrived at similar rulings that Tysabri warnings were adequate as a matter of law and that failure to warn claims were preempted.  Perhaps plaintiff lawyers will do their best to distinguish these cases on their facts.  We will, doubtless, hear that “smoking gun” has become the standard for the Wyeth v. Levine “clear evidence” standard. We heard something nearly as silly from our home appellate court recently.  But reading the Amos case in the same way that the Amos court read the Tysabri label – as a whole – there is an awful lot of comfort in that case for drug and device defendants.