This blog has discussed Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), and its progeny on multiple occasions. We provided a quick take when Albrecht was issued; discussed the decision’s possible ramifications here and here; expressed consternation at certain parts of the decision; reported here and here on how it is viewed by the plaintiffs’ bar; and analyzed cases applying Albrecht here, here, and here. And if that weren’t enough, Bexis has published an article on the decision.

Today, we provide a short report on a new law review article that takes a defense-friendly look at Albrecht and some of the open issues that survive it. The article is Victor E. Schwartz & Christopher E. Appel, Where’s the Beef?: A Guide to Judges on Preemption of State Tort Litigation Involving Branded Drugs, 89 U. Cin. L. Rev. 597 (2021).

The one true holding of Albrecht is that the “question of pre-emption is one for a judge to decide, not a jury.” Albrecht, 139 S. Ct. at 1672.

Everything else is dicta, but also where most of the action is.

Schwartz and Appel begin by recounting the Supreme Court’s recent pharmaceutical-preemption quadrilogy: Wyeth v. Levine, 555 U.S. 555 (2009); PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011); Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013); and, of course, Albrecht itself.

Central to their recounting is Wyeth’s holding that a failure-to-warn claim implicating a branded drug is not preempted “absent clear evidence that the FDA would not have approved” the labelling change purportedly required by state law. 555 U.S. at 571. That holding, say Schwartz and Appel, “is the predicate for the Court’s decision in Albrecht.” 89 U. Cin. L. Rev. at 599. Indeed, the decision addresses Wyeth’s “clear evidence” standard at the outset. It says—according to the Court, “holds”—that “‘clear evidence’ is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” Albrecht, 139 S. Ct. at 1672.

Having set the stage, Schwartz and Appel then turn to “a number of outstanding issues that will likely play out in lower courts in the wake of” Albrecht. 89 U. Cin. L. Rev. at 609.

That much remains to be decided was signaled by Albrecht itself, where “[t]wo concurring opinions offered widely divergent views on how lower courts might apply the ‘clear evidence’ exception.” 89 U. Cin. L. Rev. at 607. On the one hand, Schwartz and Appel note, Justice Thomas expressed the view that “preemption could only be obtainable where the FDA has issued a final ruling rejecting a manufacturer’s application to change a warning or has issued a supplemental ruling formally rejecting a warning change made unilaterally by the manufacturer pursuant to the CBE process.” Id. They contrast Justice Thomas’s “narrow view” with Justice Alito’s “more pragmatic approach,” which would consider not only formal agency actions with the force of law but also other FDA “communications” and conduct. Id. at 608.

According to Schwartz and Appel, given that divergence, “[t]he most important outstanding issue following Albrecht is what communication, action, or inaction by the FDA is sufficient to satisfy the ‘clear evidence’ exception.” 89 U. Cin. L. Rev. at 609.

Arguing that Albrecht does not expressly require “a formal agency ruling rejecting a manufacturer’s” proposed labeling change (89 U. Cin. L. Rev. at 610), Schwartz and Appel identify various post-Albrecht decisions that have found “clear evidence” that the FDA would have disapproved of a labeling change purportedly required by state law even though the agency did not formally reject a labeling change proposed by a manufacturer. They helpfully recount cases finding “clear evidence” in FDA inaction; in contemporaneous FDA approval of warnings other than those supposedly required by state law; and in the FDA’s denial of a citizen’s petition.

Schwartz and Appel also explain why, from a policy perspective, courts should be willing to find “clear evidence” even in the absence of formal FDA action rejecting a manufacturer’s proposed labeling change. “It is,” they say, “not difficult to imagine how problematic and disruptive” it would be if formal rejection were required before state-law failure-to-warn claims were preempted:

Risk-adverse branded drug manufacturers unsure about a potential need for an added warning would have an incentive to pursue warning changes more readily through the CBE process just so the FDA formally repudiates the warning change after it has been made, which would establish a clear basis to preempt failure-to-warn claims. As a result, branded drug warnings could experience increased volatility through back-and-forth labeling changes introduced by the manufacturer and rejected by the FDA, creating confusion for prescribing physicians and impeding patient safety.

89 U. Cin. L. Rev. at 611.

Finally, noting that “the Court in Wyeth may have created an impression that a branded drug manufacturer is generally free to unilaterally change a warning if and when it sees fit,” Schwartz and Appel emphasize that “FDA regulations make plain that the circumstances” under which the CBE regulation may be used “are limited.” 89 U. Cin. L. Rev. at 616–17. They stress that the CBE regulation may be invoked only “in light of ‘newly acquired information’” and that “the newly acquired information must provide ‘reasonable evidence of a causal association’” between the drug and “a ‘clinically significant adverse reaction[].’” Id. at 617. They then cite to various cases finding failure-to-warn claims preempted because the manufacturer could not avail itself of the CBE regulation.

With that summary, we express our thanks to Schwartz and Appel for their helpful article.

We are careful when discussing discovery sanctions, particularly spoliation, for a simple reason.  The companies we represent that make medical products tend to have allegations about failing to produce discoverable information in the course of the litigation against them.  Indeed, there is a style of litigating against drug and device companies, and other corporate defendants, that focuses on burdensome discovery, discovery-on-discovery, and motions on discovery and discovery-on-discovery in the hopes that the defendants will settle before plaintiffs get to their holy grail, default judgment entered in their favor.  The willingness of some state courts to head down this road has been a major driver in fights over litigation tourism, including personal jurisdiction and the enactment of CAFA.  Even in federal court, some MDLs—like Actos and Pradaxa—have seemed to feature allegations of spoliation by the defendants more than anything like the merits of plaintiffs’ claims.  In other litigations, it looks like the plaintiffs have pushed a similar spoliation angle, but the courts have not bought it.  Overall, when you represent a company in a bunch of cases, you know there will be lots of documents to produce and continuing claims that you did not produce enough.  If the issues in the litigation implicate events in the distant past and/or a number of entities in different places, then the chances increase that spoliation allegations will accompany the complaints about non-production.

On the other side of the “v,” it often seems like a different story.  We have tracked decisions imposing requirements on plaintiffs suing drug or device manufacturers to maintain documents, access electronic sources, produce documents, etc., and we can say that significant sanctions against a plaintiff for failing to produce documents are rare and a spoliation instruction against a plaintiff is rarer.  Purcell v. Gilead Sciences, Inc., No. 17-3523, 2021 U.S. Dist. LEXIS 77379 (E.D. Pa. Apr. 22, 2021), takes a deep dive into these issues in a False Claims Act case brought by two former sales representatives over the marketing of two of defendant’s drugs.  We will jump to the end and state that the plaintiff was assessed relatively small financial sanctions and a spoliation instruction was denied without prejudice while a last-ditch effort was going to be pursued to find some of the missing materials.  As we recount a boiled-down version of history and the court’s analysis, we invite the reader to ask the question “how would things be different if the defendant manufacturer and its counsel did what the plaintiff and his counsel did here?”  Ask it a few times if you want.

The nature of the Relators’ allegations are not clear, but they clearly implicated the preservation and discovery of text messages they sent while working for the defendant.  In fact, one of the relators (we will call her “Relator 1”) produced thousands of text messages, including hundreds to/from the other relator (we will call him “Relator 2”), and attempted to withhold hundreds more.  Relator 2 produced five text messages and attempted withhold nine more, all to/from Relator 1.  This was a tip off for the defendant.  Although the suit was filed in 2017, concerned events starting before then, and he kept working for defendant until 2018, the few texts Relator 2 produced started in July 2019.  This was another tip off.  Despite an order requiring the parties to preserve documents and making text messages discoverable, multiple representations of relators’ counsel about compliance, letter writing, motions practice, hiring an independent third-party vendor, a deposition of Relator 2, and two hearings—the latter of which included experts for both sides—Relator 2 still had not produced an additional text message one year later.  Yet, the record was quite clear that otherwise discoverable messages existed when the suit was filed—by which time the relators certainly had to retain relevant evidence—and were created while the case was pending but before discovery began after the case was unsealed.  That is the short version.  While spoliation inferences and instructions under Fed. R. Civ. 37(e) require the court to find that “the party acted with intent to deprive another party of the information’s use in the litigation,” the reality is that a party—particularly a large corporate defendant—will have to come forward with a convincing explanation about the lack of bad intent.  Here, the court found that Relator 2 and his counsel had offered no such explanation.  Even though the court found that they had failed to comply with its orders and misrepresented compliance to the defendant, it determined the record was insufficient to find that Relator 2 had acted with such bad intent.

The longer version (even our abridged version of it) sounds way worse.  Relator 2 had five electronic devices and cloud storage as potential sources of electronic information.  The main focus was the smartphone he used from 2013 through March 2019, when he replaced it with a new model and put the old phone in a drawer in his house.  He never produced a text message from the first phone, which he had used in connection with his employment for defendants over five years, including almost a year after bringing suit.  The old phone did not go to his counsel until after opposing counsel had complained about the adequacy of production and been assured that all reasonable steps had been taken to preserve documents and produce them, including Relator 2’s texts.  In the interim, it had been wiped.  The independent vendor found forty-two unproduced texts in the backup for his new phone, but efforts to get texts from the old phone from any of the obvious sources had failed.  The mysterious wiping may have been—again, Relator 2 and his counsel offered no benign explanation, just ignorance and non-compliance—from one of Relator 2’s daughter taking phone from the drawer, changing the passcode through the cloud service, and trying to use it as her own phone, which resulted in a number of failed attempts to access the phone before providing it to a vendor.  Of course, the old phone and the various back-up sources were known to be sources of evidence in a pending federal lawsuit, but the relators’ counsel did not obtain them until late in the game.  Even when the court held the first hearing and ordered relators to facilitate the third-party forensic review, relators’ counsel somehow failed to turn over the new phone or information to allow cloud access for the old phone.  We could go on, especially if we wanted to highlight how a corporate defendant could never get away with such apparent shenanigans.

Instead, we will go to the rulings on the two types of sanctions sought, basically costs under 37(b) and spoliation under 37(e).  On the former, the court found lots of non-compliance by Relator 2 and his counsel.  For instance, they “did not comply with their obligations to preserve any possible evidence,” counsel “did not ensure compliance with [the ESI order] by undertaking reasonable steps to ensure all of his electronically stored information including his text messages shall not be permanently deleted or altered,” and they “offer no explanation for this failure to preserve since August 2017 and disregard of our [ESI order] despite their statement of compliance on March 18, 2020.”  Id.at **22-24.  Such non-compliance (and misrepresentations) caused the defendants to incur significant costs and fees, for which relators’ counsel was ordered to pay up to about $20,000 plus the full cost (instead of half) of the third-party vendor’s work.  In addition to that not being much given the conduct at issue, it was also payable by counsel not Relator 2.  As the court found, “[w]e have no basis to impute the Relators’ counsel’s strategy on disclosing partial information to Mr. Purcell and thus do not impose a monetary sanction on him nor may his lawyers seek or obtain repayment from their clients.”  Id. at *25.  This may change, though, as further sanctions were possible once the third-party vendor finished its work.  That work could change the court’s finding—with our italics—that there was “no basis today to find Mr. Purcell” was personally responsible for wiping the old phone or preventing access to its backup.  Id. at *22.

That could also change the denial without prejudice on the second type of sanctions sought.  While the court found that it could not meet the 37(e) requirement of Relator 2’s “intent to deprive” the defendant of the text messages from his old phone—the one he used during the relevant time period, including for a year and a half after he brought suit—it did find Relator 2 and his counsel “acted in conscious disregard (either through oversight or negligence) in their preservation of electronically stored information.”  Id. at *28.  It also noted they had no benign explanation for how or when the old phone got wiped.  If further evidence shows that Relator 2 or his lawyers “intentionally deleted these texts as opposed to his family using and changing the activation code and [] backup” in a way that led to accidentally deleting everything from the old phone, then an order for an adverse instruction would probably be issued.  Id. at *33.  As we suggested at the start, we prefer litigation to be decided on the merits rather than on motions about discovery.  That preference applies across the board, but we do look forward to evening out the playing field when it comes to the rules for discovery and potential sanctions on both sides of the “v.”

 

Bexis just turned 65 (on 1/25/2021) – the classic retirement age.  That’s an occasion to look back and evaluate what’s gone on over the course of an entire legal career.  So how have we done, as defense lawyers, over the course of our entire careers, at our primary job – which is to prevail for our clients in drug and medical device product liability litigation?  We’re lawyers.  We work for clients.  Thus, the bottom line, in a legal career, as in an individual matter, is:   Are our clients better off now than when we started?

Bexis started practicing law in 1982 (in the depths of a legal recession, he received only one offer from a law firm in Philadelphia, where he wanted to practice).  So, we’ll take that as a starting point.

Personal Jurisdiction

Great progress here.  For decades any of our corporate clients were subject to “general” personal jurisdiction (being sued for anything occurring anywhere) in any state where they did “continuous and substantial” business.  Beginning in 2010, we started following personal jurisdiction decisions.  Since then, general jurisdiction has largely been defanged – limited to a corporation’s principal place of business and state of incorporation.  A huge victory, Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), has raised the possibility of elimination of litigation tourism altogether, but follow-up has been mixed.

Since BMS, California, Illinois and New York mostly respect the Supreme Court’s decisions, but Pennsylvania does not.  Personal jurisdiction has also largely put a stop to multi-plaintiff, misjoined complaints as a way of defeating diversity jurisdiction and aggregating claims where plaintiffs want them.  Perhaps by this June there will be more clarity, when the Supreme Court tackles stream of commerce jurisdiction post-BMS.  But those cases do not involving forum shopping plaintiffs, so it’s hard to say.  Another opportunity, yet to be realized, could use personal jurisdiction as a basis substantially to restrict the use of nationwide class actions.  Even where we are, though, is an incomparably better place than where our clients were when Bexis’ generation of defense lawyers began their practices.

Preemption

And how about preemption in tort litigation?  Back when Bexis’ generation was getting started, it essentially didn’t exist.  Thank/blame cigarette defense lawyers (something Bexis also did for a while at a prior firm) for changing that, beginning with Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992).

It didn’t start well for us.  We manned the barricades during the first wave of FDCA preemption litigation, in vaccine cases, but got clobbered.  We took it on the chin again, in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which was decided only a few months after Bexis had succeeded in getting about 85% of the claims in the Bone Screw litigation preempted.  Back to the drawing board.  What’s left after Lohr?  Well that claim the Bone Screw plaintiffs were pushing for “fraud (on the FDA)” should be preempted because it’s based on the FDCA, and an obscure section of that statute prohibits private enforcement.  Try implied preemption, write it up, and let’s see what happens.  Presto:  We get Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), a few years later.

Then we get a degree of medical device preemption back in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), with extensive preemption with respect to pre-market approved medical devices (a minority of all devices), with the boundaries still being fought over.  The pendulum swung again with a bad loss in Wyeth v. Levine, 555 U.S. 555 (2009), that left our ears ringing for a while.  But our side pulled itself off the deck to score wins in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), and to a large extent in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  Thus, even in prescription drug cases, there is now a lot of preemption to be had, as our drug preemption cheat sheet shows.  With some help from Congress, our side even obtained a measure of revenge for our vaccine clients in Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011),

So while preemption is still a major battleground, is now represents our clients’ most powerful defense.  When we started out, back in the 1980s, it essentially didn’t exist.  Preemption is another major accomplishment of Bexis’ generation of defense lawyers.

Class Actions

Another greatly positive development has been the virtual eviction of class actions from product liability claims involving personal injury.  If you wonder why class actions rank this high, you don’t remember what it was like in drug/device litigation in the 1980s and 1990s.  Back when Bexis’ generation started their legal careers, we had to take class actions in product liability litigation very seriously.  While there were never a lot of certifications, there were enough of them that – during the Fen-Phen and Bone Screw litigations, for example – plaintiffs would argue that there was some sort of “modern trend” favoring certification of personal injury class actions.  Some courts so held.  See In re A.H. Robins Co., 880 F.2d 709, 738 (4th Cir. 1989) (later abrogated).  Bexis remembers how relieved we were beating the class certification motion in Bone Screw, and now depressing it was when the opposite happened (at least in a state court) in Fen-Phen.  One turned into a broad defense victory, while the other produced one of the most abused settlements in mass tort history.

Then our side of the “v.” prevailed in Amchem Products, Inc. v. Windsor, 521 U.S. 591 (1997), and Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999).  Since then – with a lot of blood, sweat, and good legal argument from our side – class actions (at least successful ones) largely disappeared from mass torts, as we’ve discussed before.  Check out our federal and state class action cheat sheets.  The few courts willing to certify class actions in drug and medical device cases have so far gotten shot down on appeal (in the St. Jude litigation) or threw in the towel (on Zyprexa).  Following enactment of CAFA, most class action decisions going forward, and essentially everything in mass torts, will be made by federal courts applying post Amchem/Ortiz law.

Medical monitoring, a non-personal-injury derivative of personal injury causes of action that the plaintiffs’ bar dreamt up with class actions in mind, has largely failed in recent years to produce very many successful certifications – despite lots of attempts.  Thank defense counsel for ensuring that the claimant-specific elements of medical monitoring have been preserved, even as some courts have recognized the claim.

Likewise, class actions involving purely economic losses, usually brought as adventurous applications of consumer fraud, RICO, or warranty claims, have had rough going – at least in the drug/device field.  And if the United States Supreme Court ever finds a case that it can review on the merits, we think that the abusive cy pres practice of giving supposed “class” recoveries to pro-plaintiff charities will be defeated.

As a measure of how far out of the mainstream tort class actions have become over the last couple of decades, the ALI’s Aggregate Litigation principles project, for all its pro-plaintiff leanings in other areas of the law, states quite clearly that personal injury class actions are disfavored for a variety of reasons.

There’s also a distinct trend afoot, not limited to tort cases, to tighten consideration of class action allegations.  We have the rise of ascertainability.  The old rule of no “merits” consideration during class certification is out the window.  The Supreme Court is going to consider another of our bêtes noir, the no-injury economic loss class action.  Maybe more favorable movement will occur.

To top it all off, our side has also had a good deal of success arguing against cross-jurisdictional class action tolling – that failed class actions filed in one court should not toll the statute of limitations on claims filed in a different court.  That deprives failed class actions of the one substantive benefit that they could confer upon plaintiffs (as opposed to their lawyers).

We’re still litigating economic loss and similar no-injury class actions, but overall our clients are a lot better off on the class action front now than they were when we got into this business.

Expert Witnesses

One word:  Daubert.  Back when Bexis’ generation started practice, the courts waved through just about any garbage that a plaintiff’s expert wanted to say.  See Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741, 744-45 (11th Cir. 1986) (allowing testimony with no epidemiologic or other statistically significant support for the proposition that spermicide, intended to prevent conception, was defective for purportedly causing birth defects).

Then came Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U .S. 579 (1993).  At first the effect of Daubert was unclear.  It could have been interpreted as loosening the already capacious federal standard for expert certification even further.  But Bexis’ colleagues on the right side of the “v.,” with a lot of hard work and inspired argument, gained the upper hand and Daubert is now synonymous with more scientifically rigorous expert admissibility standards.  What mattered most wasn’t the language standard itself, or of Rule 702, but Daubert’s requirement that judges – not juries – act as “gatekeepers” of admissible expert testimony.  Given the amount of junk science that plaintiffs’ experts were spewing, if we could just get courts believing that they had an obligation to review things critically, we would win.

Daubert was a drug case. It was the Bendectin litigation’s lasting gift to the legal profession.  It’s taken several return trips to the Supreme Court to nail it down.  See General Electric Co. v. Joiner, 522 U.S. 136 (1997); Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999); Weisgram v. Marley Co., 528 U.S. 440 (2000).  And we may well need more, since some federal courts, particularly the Ninth Circuit, have been lax at enforcing what we think Daubert intended to accomplish.

After a while, the Daubert divide’s gotten to be like night and day.  We don’t win every case, but we win a lot more of them than before.  Nineteen years after Wells, the same court decided McClain v. Metabolife International, Inc., 401 F.3d 1233 (11th Cir. 2005), reversing and requiring judgment n.o.v. where an expert relied on little more than temporal association. That’s monumental change for the better.  These days, a couple of MDLs a year are wiped out by favorable Daubert expert exclusion decisions.

Another beneficial aspect of Daubert – stringent substantive review of expert opinions, by whatever name – is increasingly finding its way into state court decisions as well, in places like New York, Texas, New Jersey, and even Florida.  It’s not perfect, but compared to where Bexis’ baby boom cohort of defense counsel were when their careers started, this is another area where we think that, after all our laboring in the litigation vineyards, our clients are a lot better off.

Pleading

Another accomplishment of Bexis’ generation of defense counsel is strengthened requirements for pleading actual facts, rather than legal conclusions, in federal court.  The blog has been all over Ashcroft v. Iqbal, 129 S. Ct. 1937 (U.S. 2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), from the beginning.  We even popularized a shorthand for what the Supreme Court did – “TwIqbal.”

TwIqbal has every right to be popular, at least among our clients and colleagues.

Before these decisions, the federal pleading standard was a joke.  Plaintiffs could survive a motion to dismiss without pleading a single actual fact, only the same boilerplate they could repeat over and over again in thousands of identical complaints, with only the names changed to encourage the greedy.

Now, under TwIqbal’s “plausibility” standard, things have gotten much better.  How much better?  Well, our TwIqbal cheat sheet includes only drug/device cases, and imposes a very high bar for adding cases – no claims must survive a motion to dismiss, no matter how good some of the rulings might be.  It now contains almost 300 cases.  In particular, TwIqbal has done an excellent job in combination with post-Riegel device preemption cases, with most (but not all) courts requiring plaintiffs to plead facts, not “magic words,” when claiming purported FDCA violations.  That’s very concrete improvement.

And it’s carried over to other areas as well.  Our TwIqbal cheat sheet includes a wealth of cases requiring plaintiffs to plead things like warning causation in learned intermediary rule cases, a deviation from intended result when a manufacturing defect is alleged, and the language of any supposed express warranty.

So from the outset of litigation – the adequacy of the initial pleadings − our clients are a lot better off than when we first got our seats at the table.

Learned Intermediary Rule

When we started out, the learned intermediary rule was already widespread, but today it is essentially universal.  Our state-by-state synopsis of learned intermediary rule cases now has something favorable from every jurisdiction in the country.  Only one state ever rejected the rule, and that has been overruled by statute.  On the other side of the ledger, Bexis alone has been involved in decisions adopting or reaffirming the rule in seven states (PA, NJ, OH, CT, KY, TX, AZ).  All told, the number of jurisdictions with high court or statutory adoption of the learned intermediary rule has reached 36.  The most populous state with less than high court adoption is Indiana, where the intermediate appellate court has followed the rule since 1979.

Beyond simply the number of states adopting the learned intermediary rule, we’ve also seen a strong trend towards its expansion in various directions. It’s expanded from drugs to medical devices. The rule has grown from being mostly about adequacy of warnings to now having its greatest use in determining whether an allegedly defective warning had any causal effect.  If the learned intermediary physician doesn’t read the warning (or knows what a “better” warming allegedly would reveal), there’s no causation.  The rule has also expanded from failure to warn claims to other claims such as consumer fraud.  The rule has also been increasingly applied to protect entities like pharmacists, in addition to product manufacturers.

While the learned intermediary rule isn’t as powerful a defense as preemption or Daubert, it is an effective way of getting rid of individual cases, since in most cases, the prescribing physician is an independent witness who does not say whatever plaintiff’s counsel wants.

So back when Bexis’ generation got started, while the learned intermediary rule was a majority rule, the other side (and its academic fellow travelers) still had ambitions of getting rid of it.  Those ambitions have been crushed.  So with the learned intermediary rule as well, we’d have to say that our clients are quite a bit better off now than when 65-year-olds began practicing law.

Prevention of Innovative Liability Theories

In the early 1980s, when Bexis’ peers graduated law school, market share liability was a major threat to burst its DES bounds and become generally accepted.  That hasn’t happened.  No state has adopted it since Hawaii in 1991, and some of the states that did so earlier, like New York, have tightly confined it to the original DES set of facts. Score one for the good guys.

The third Restatement of Torts, adopted in 1997 and published the following year, cut back on some of the loopier aspects of strict liability, including liability for unknowable risks, and failure to recall/retrofit claims.  Those claims haven’t gone much of anywhere, either, and we have been able to cut back on the loopy idea that “negligence” must be kept out of strict liability.  We’ve largely kept an independent duty to test out of the law, too.  Fraud on the FDA got preempted out of existence.

The advent of broad preemption (discussed above) has led to plaintiffs arguing for a variety of novel liability theories.  The most dangerous of these is innovator liability – imposing liability for injuries caused by (preempted) generic drugs (90% market share) on the (unpreempted) manufacturers of bio-equivalent branded products (10% market share).  While two outlier states have adopted innovator liability, the feared rush has not materialized, and the defense appears to have stemmed that tide.  Another bizarre theory is “warning” liability based on alleged failure to report adverse events to the FDA.  Since the overruling of a bad Ninth Circuit prediction of Arizona law by the Arizona Supreme Court, that theory, too, is resembling a bad idea whose time has passed.

Our desire to combat novel theories is why we have pushed Erie conservatism on the Blog since day one.  Since so much of drug/device litigation is in the federal courts, emphasizing federalist restraints on “prediction” of novel liability is one way of combating judicial activism in this area.

But we’ve hardly been universally successful.

Despite our best efforts, consumer fraud claims have become staples of our opponent’s litigation strategy, and thus banes of our existence.  When Bexis’ cohort first started practicing law, practically nobody ever encountered them.  Now, they’re routine.  However, in most instances, courts have ruled that such statutes can’t be enforced extraterritorially, outside of the state that enacted a particular statute.  That at least cuts down on the size of any attempt to aggregate claims.

Another negative on Bexis’ watch is that medical monitoring went from a legal peculiarity to, if not a majority rule, at least being allowed by a fair number of states, as our 50-state survey shows.  So we haven’t been able to stop that one either.  Something else we didn’t see much of back in the 1980s was the so-called post-sale duty to warn.  That’s proliferated quite a bit, as even the Third Restatement included it.  Fortunately, there aren’t that many post-sale duty claims in our neck of the woods, and they tend to be preempted.

We’ve waged a see-saw battle with negligence per se claims based upon alleged FDCA violations.  Many the older cases that were around when Bexis’ cohort was getting started allowed those claims without a lot of discussion, because after all the FDCA was enacted to make products safer, wasn’t it? However, the principle that the FDCA prohibits plaintiffs from privately enforcing the statute against violators, enunciated by the Supreme Court in Buckman, has helped our clients defeat those claims more often in recent years.  We’ve also pushed a variety of state-law arguments.  But negligence per se hasn’t yet gone the way of the dinosaurs, and some courts still allow such claims.

Finally, we thought we had “public nuisance” beat in the drug/device arena.  But lately, it has made something of a comeback.

All this adds up to a mixed record in beating back the various novel theories of liability that plaintiffs have invented over the years.  We’ve gotten rid of some altogether, and limited others.  But some genies have escaped from the bottle despite the best efforts of our generation of defense lawyers.

First Amendment and Off Label Use

When Bexis’ generation started, the First Amendment had just been extended to commercial speech.  The notion that the First Amendment could limit the FDA’s ability to prohibit truthful manufacturer speech about off-label uses hadn’t even been invented yet.

In the Bone Screw litigation, plaintiffs sought to make off-label use – physician employment of drugs and devices for uses beyond what FDA-regulated labeling stated – into some kind of tort.  Buckman killed that, recognizing off-label use as legal, “accepted and necessary,” and “generally accepted.”  531 U.S. at 350-51.

Now we have Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011), United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and similar cases.  The FDA has started to back-peddle, and given where the Supreme Court seems to be going on strict scrutiny of content- and speaker-based restraints on commercial speech, it may just be a matter of time before the FDA’s ban falls.

When Bexis started raising this issue in the Bone Screw litigation, people chalked it up to overzealousness on behalf of his clients.  Now we have the Medical Information Working Group.  His generation of lawyers made something out of nothing here.

Discovery

Now we get into our failures.  Even though we’ve had some success modifying the federal rules of procedure, electronic discovery remains mostly unfettered as a new and excessive cost to our clients.  When Bexis’ generation started out, there was no such thing.

Now electronic discovery has gotten entirely out of hand.  It’s hideously expensive, ridiculously intrusive, and almost entirely a one way street.  It often leads to satellite litigation over discovery.  Although we’ve advocated electronic discovery for defendants – to the point of having a cheat sheet − tort plaintiffs simply don’t often have large, frequently upgraded computer systems that lead to the imposition of astronomical discovery costs.  In large litigations, maybe one in a million of electronically produced documents is ever used at trial.

Everything else that our side’s been able to accomplish in limiting or streamlining discovery – routinized plaintiff questionnaires, federal-state coordination, restrictions on apex depositions, the inadvertent production doctrine, etc. – pales by contrast to the constantly metastasizing disaster that is electronic discovery.

Reducing Overall Litigation

Utter, absolute failure.  Mass tort MDLs now make up half the total federal case load.  The other side has been much more efficient in soliciting large numbers of plaintiffs to populate the ever growing number of pharmaceutical and medical device mass torts than our side has been in stopping them.  The racket that mass torts have become is so downright predictable that we parodied it years ago – but had to update that parody because in MDLs, irony is dead.

Beneath everything lies the simple fact that, since the Supreme Court’s first benighted decision in Bates v. State Bar of Arizona, 433 U.S. 350 (1977), extending First Amendment protection to lawyer advertising, the other side’s solicitation machines have become more and more effective, and there’s not a constitutional thing we can do about it.  Even when our side gets a crumb from the Supreme Court, such as Florida Bar v. Went For It, Inc., 515 U.S. 618 (1995), upholding a trivial 30-day cooling off period from personalized solicitations, the vote was only 5-4.

Mass torts are all about volume.  As we lamented in “Anatomy of a Mass Tort 2.0”:

Regardless of what is the triggering event, the creation of the mass tort itself follows – almost entirely extra-legally.

Advertisements.

Since the courts discovered that lawyers have a constitutional right to use advertisements to solicit clients, they have done so – with a frequency that would no doubt have shocked the Founding Fathers.  Anybody who watches TV knows what we’re talking about.

And it’s not just lawyers, either.  Media specialists and third-party litigation funders also combine to run (with apologies to Marlowe) the race that launched 100,000 TV (and internet) ads.  Anyone who responds – and many do – becomes “inventory,” their claims available for sale in bulk to enterprising lawyers hoping to cash in on the next mass tort.

Thus, within hours after the triggering event, “law firm” websites will invite product users to sign on as potential clients.  Similar solicits in other forms of media follow.

This early stage is usually the point of no return.  The lawyers involved will freely buy, sell, and trade the would-be clients that have signed up – to the point where those clients often don’t know who their lawyers actually are.  But once they have clients, no matter how attenuated the relationship, lawyers cannot ethically let them go.  Regardless of the facts, the mass-tort litigation process takes on a life of its own.

As long as society tolerates virtually unlimited lawyer solicitation as a constitutional right, there’s not a lot of ways for our side to close the litigation floodgates.  So in this most fundamental of our client responsibilities – protecting them from litigation – Bexis’ generation of defense counsel has not been able to do what their clients need most.

Not that we haven’t tried; it’s just our side’s efforts to stop the onslaught of boilerplate, virtually uninvestigated filings hasn’t accomplished very much.  Lone Pine orders and plaintiff fact sheets are a handy invention, but they only channel and divert the torrent; they don’t stop it.  Nothing seems to.  Look at the list of the most popular drugs of 10 years ago.  Well over half of them have been the subject of coordinated mass torts – usually MDLs.  Are most of the widely prescribed drugs defective?  Is the FDA that incompetent.  Of course not.  Those drugs are simply the ones with the volume of sales to support the current mass tort racket.

And our side, Bexis’ generation, has been unable to stop this trend.  If everything that we do is ultimately supposed to contribute to deter future litigation against our clients, then it hasn’t worked at all.  Maybe it’s time for us to get out of the way and let the next generation of defense lawyers try their luck.

With 2020 mercifully coming to an end, it is once again time for the Drug & Device Law Blog’s top ten decisions of the year.  In keeping with COVID-19’s dominance of 2020, we present our top ten in the context of countermeasures against another social ill – the tort pandemic raging across much of the nation.  Some of the cases here will keep our clients socially distant from aggregate litigations in superspreader venues where only plaintiffs want to be.  Others resemble personal protective equipment, shielding our clients from harmful allegations in conflict with regulatory oversight.  Others are more like vaccines, inoculating our clients from dangerous liability theories.  Still others more resemble the central attribute of the effort to create COVID-19 vaccines – that science must be respected and the crackpot theories peddled by the other side would do more harm than good.

Next, our annual reminder.  Our scope of coverage is limited.  Our top (and bottom) ten lists are limited to cases involving prescription medical product liability litigation (relatively broadly defined).  Cases are decided each year that significantly impact what we do, even though not involving prescription medical products.  So, we’ll salute Rockhind v. Stevenson, 236 A.3d 630 (Md. 2020), adopting Daubert; Berry v. the City of Chicago, ___ N.E.3d ___, 2020 WL 5668974 (Ill. Sept. 24, 2020), rejecting no-injury medical monitoring; Texas Brine Company, L.L.C. v. American Arbitration Association, Inc., 955 F.3d 482 (5th Cir. 2020), in which a third straight court of appeal approved of removal before service; and Exela Pharma Sciences, LLC v. Sandoz, Inc., ___ F. Supp.3d ___, 2020 WL 5535026 (W.D.N.C. Sept. 15, 2020), preempting attempts to second guess FDA product decisions in commercial litigation.

Enough with the introductions.  Now, let’s proceed with the protective measures.

  1. Rios v. Bayer Corp., ___ N.E.3d ___, 2020 WL 2963318 (Ill. June 4, 2020).  For decades, litigation tourist plaintiffs looking for generous juries and favorable rulings have flocked to Madison, Cook, and St. Clair counties in Illinois.  After Rios it’s time to start mucking out these Augean stables.  Rios applied the Supreme Court’s BMS (2017+1) decision the way it was intended, to prevent any plaintiff from anywhere from relying on secondary or immaterial forum “contacts” that had nothing to do with their cases as a basis for personal jurisdiction.  160 out-of-state plaintiffs (suing in Madison County) advocated a “loose and spurious” form of general jurisdiction under the guise of “specific” jurisdiction.  They cobbled together supposed forum “contacts” that had nothing to do with their cases − “clinical trials,” us[ing] the state . . . for [a] physician training program,” “orchestrat[ing] a marketing campaign” – even though they weren’t in the trials and were unaffected by either the training or marketing.  In stark contrast to our worst case of 2020, Rios refused to allow “specific” jurisdiction to be based on “contacts” so general that any plaintiff from anywhere could assert then.  Without the plaintiffs themselves being prescribed, having purchased, or ever using the product in state, no “meaningful” basis for meeting the “arising from”/”relating to” standard for specific personal jurisdiction existed in Rios.  “Illinois has no particular interest in resolving claims that did not arise out of or relate to activities that occurred here.”  Further, all these “out-of-state plaintiffs could pursue their claims elsewhere.”  And since a number of the plaintiffs in fact had filed suit elsewhere, judicial economy also supported dismissal.  Cleaning up an earlier mess, Rios also expressly overruled the earlier M. (2016-8) decision which had held that clinical trials established jurisdiction even for non-resident plaintiffs who were never trial subjects.  Since Illinois has already rejected general jurisdiction by consent, that means that litigation tourists are now out of personal jurisdiction arguments in Illinois.  We rhapsodized about Rios here.
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  3. Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., 239 A.3d 1175 (Conn. 2020). The Connecticut Supreme Court unanimously affirmed the complete preemption of prescription drug design defect claims.  State judges are generally less friendly towards federal preemption of their state’s law than federal courts, so that’s an accomplishment right there.  Applying one of our favorites − the “Mensing (2011+1) independence principle” – Boone preempted a rather unusual contention that the defendant should have not have sold an FDA approved product until also getting FDA approval of a supposed “antidote.”  This purportedly common-law claim rather explicitly sought to hold hostage an FDA approved drug until a separate, later FDA action approving a different drug.  Beyond being contingent on agency action, that claim was further preempted as a “stop selling” claim under Bartlett (2013+1) because the only way to avoid liability under the plaintiff’s theory was not to sell the FDA-approved product at all, pending development of a second drug.  The court explicitly rejected plaintiff’s argument (which we see all the time) that Mensing and Bartlett should be limited to generic drugs, and instead agreed with Yates (2015+1) to hold that Supreme Court’s implied preemption analysis was broadly applicable.  Also rejected was another common claim from the other side, that Albrecht (2019+1, 2019-6) required all prescription drug implied preemption arguments to jump through the hurdles of the “clear evidence” test.  That test only applies if the FDA’s CBE regulation applies and allows unilateral warning revision.  CBE Bartlett is not a basis for changing drug design or availability.  Finally, the plaintiffs’ claim that it “pre-approval” design defect claims escape preemption was also rejected as another variant of a stop selling claim.  We went bonkers for Boone here.
  4. In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), ___ F.3d ___, 2020 WL 7214264 (2d Cir. Dec. 8, 2020). Our best Daubert decision of 2020 was decided earlier this month.  Short but oh so sweet, the Second Circuit affirmed in toto In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 387 F. Supp.3d 323 (S.D.N.Y. 2019), which was our 9th best case of 2019.  The court properly held that none of the plaintiffs’ experts offered general causation opinions that could withstand any degree of scientific examination.  This result seems obvious – the condition at issue is “idiopathic intracranial hypertension,” and “idiopathic” means precisely that cause cannot be determined – but other circuits have been much more hospitable to junk science.  Not Mirena.  Plaintiffs first argued that the inquiry into their experts’ methods was too rigorous.  Mirena court affirmed that Daubert requires a “hard look” at expert opinions and that “an expert’s methodology must be reliable at every step of the way,” emphasizing the necessity of “rigorous examination.”  “[N]ot only was it appropriate for the district court to take a hard look at plaintiffs’ experts’ reports, the court was required to do so to ensure reliability.”  Then, with almost Shakespearean inconsistency, plaintiffs complained about the trial court considering their experts’ conclusions, as opposed to their methods.  Wrong again.  Mirena holds that it is entirely proper, as a Daubert factor, to consider that an expert’s conclusions are not generally accepted.  Mirena also affirms that support by published studies may be required where the expert’s methods are not otherwise reliable, and rejects differential diagnosis as the sole basis for a general causation opinion.  Affirming summary judgment, Mirena also recognizes that “there is a general causation requirement across all states.”  We marveled at Mirena here.
  5. In re Taxotere (Docetaxel) Products Liability Litigation, 966 F.3d 351 (5th Cir. 2020). The passive aggressive approach many MDL plaintiffs and their counsel take towards their obligations to complete “fact sheets” or similar disclosure documents is one to the banes of any MDL defense counsel’s existence.  Missed deadlines and incomplete answers abound and require inordinate amounts of work keeping track of deficiencies and notifying plaintiffs repeatedly of their failure to meet their obligations.  MDL deficiency proceedings drag on for many months.  That’s what happened in Taxotere.  After more than four months of inaction, the plaintiff hadn’t done a thing – no submission at all.  Only after the MDL court set a hearing did plaintiff make a woefully inadequate submission.  After a judicial sanctions warning, followed by yet another round of extensions and deficiencies, the court had finally had enough and dismissed the case with prejudice.  Plaintiff appealed and lost, bigtime, in a rare published appellate opinion on this topic.  Taxotere is a long overdue reaffirmation of the power of MDL judges to impose the ultimate sanction of dismissal with prejudice on MDL plaintiffs who only want to wait for settlement, while doing nothing.  Taxotere rejected plaintiff’s dithering, multi-factor argument in favor of a simple review of the MDL court’s discretion to dismiss – was there a “clear record” of delay, and would “lesser sanctions” suffice.  In Taxotere there was extensive delay, which in and of itself demonstrated that no lesser sanction would stop it.  No fact sheet; no case.  Dismissal sanctions had to be real and enforceable.  We touted Taxotere here.
  6. This entry is from the non-RS side of the blog. Dolin v. GlaxoSmithKline LLC, 951 F.3d 882 (7th Cir. 2020). Again?  The Seventh Circuit reaffirms its prior decision that we named as fifth best decision of 2018.  The court rejected an argument that Albrecht (2019+1, 2019-6) precluded defendants from ever having “clear evidence” that the FDA would have rejected the warning in question unless the particular defendant itself had unsuccessfully submitted the particular warning to the FDA.  Instead, the FDA’s decision to impose classwide labeling on the defendant’s drug that did not contain the language plaintiff advocated sufficed as “clear evidence” of an adverse FDA’s decision − whether or not the particular defendant being sued actually submitted a label change.  Albrecht did not repudiate the “would have” rejected standard in Levine (2009-1), but merely clarified it.  Rather than overrule or make huge changes to Levine, the principal holding in Albrecht was that preemption is a question of law.  The record showed that the FDA had “full information” from the defendant, so preemption was not defeated by the FDA deciding to act more broadly than in a product-specific manner.  Classwide labeling is formal enough to be a preemptive FDA action.  Thus, the court emphasized the parts of Albrecht we liked and minimized those parts we did not.  We (well some of us) discussed Dolin here.
  7. In re Viagra (Sildenafil Citrate) & Cialis (Tadalafil) Products Liability Litigation, 424 F. Supp.3d 781 (N.D. Cal. 2020).  These favorable Daubert decisions should spell the end of another MDL.  All of plaintiffs’ general causation experts excluded after a 4-day Daubert hearing.  A single medical journal article reporting an “association” was not enough.  Association is not causation.  Plaintiffs’ experts’ Bradford Hill analysis was result-driven and truncated, relying on a single factor – association – to the exclusion of the other eight factors.  Plaintiff’s theory was not supported by any scientist, researcher, regulatory agency, or other qualified person, save their own paid experts.  The science was all the other way.  Lots of things may be biologically “plausible,” but that doesn’t mean they have any actual scientific support.  Science worked.  An article found an association and suggested further study.  Other scientists took up the challenge, but nothing more significant than the initial association has been found.  A very good decision, particularly from a court in the Ninth Circuit.  We vouched for Viagra here.
  8. Keen v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2020 WL 4873634 (E.D. Pa. Aug. 19, 2020) & Keen v. C.R. Bard, Inc., ___ F. Supp.3d ___, 2020 WL 4818801 (E.D. Pa. Aug 19, 2020). Two excellent decisions handed down the same day.  These could just as well have been issued as a single opinion, so we consider them together.  The first decision is notable for its solid reaffirmation of established Pennsylvania law precluding strict liability in prescription medical product liability litigation.  Pennsylvania appellate decisions involving prescription medical product liability litigation are unanimous in rejecting strict liability, and so are vast majority of federal cases that purport to apply Pennsylvania law.  Also cites nonbinding jury instructions.  The other parts of the opinion, denying summary judgment on other claims, are routine and pale by comparison.  The second Keen opinion concerned trial evidence, and rejected the fallacy − adopted primarily in pelvic mesh cases like Eghnayem (2017-2), and Cisson (2016-2) − that evidence of FDA §510(k) clearance is excludable as irrelevant or unduly prejudicial to plaintiffs.  This was never the law prior to Pelvic Mesh, and was created not so much from the law, but rather to force settlement.  Not anymore, since Keen held that the jury, “after taking into consideration the history of the FDA’s 510(k) clearance of the [product], could determine that [defendant] took reasonable and appropriate steps in its effort to bring [the product] to market.”  That’s the right result, since in no other area of tort law is regulatory compliance viewed as an all or nothing (preemption or inadmissibility) proposition.  We gave kudos to Keen here and here.
  9. Cavanaugh v. Stryker Corp., ___ So.3d ___, 2020 WL 5937405 (Fla. App. Oct. 7, 2020). Defense counsel managed an excellent result despite some pretty bad facts in Cavanaugh.  The key to the case was misuse of the device by medical personnel who failed to read the defendant’s warnings.  The key to the appeal, and why it made our list, is some pretty basic product liability law.  As in many states, Florida allows proof of design defect on the basis of either “consumer expectation” or “risk/utility” theories.  Defendants, particularly those that manufacture complicated products like medical devices, much prefer the latter to the former, and in Cavanaugh the District Court of Appeal agreed.  The consumer expectation test does not logically apply to a prescription-only product about which a “ordinary consumer” would not have any meaningful expectations.  These rulings should have lasting impact in Florida.  Further, since the appeal came in the context of objections to jury instructions, plaintiff never requested an instruction that the “learned intermediary” was the “consumer” for purposes of measuring consumer expectations.  We commended Cavanaugh here.
  10. (Tie) Stiens v. Bausch & Lomb Inc., ___ S.W.3d ___, 2020 WL 7266398 (Ky. App. Dec. 11, 2020). This late addition to our list reaffirms both the purely federal nature of allegations concerning truthful off-label promotion and the vitality of the state of the art defense in a case where the off-label use at issue was also the medical standard of care.  Yes, the defendant engaged in off-label promotion, but plaintiff had no evidence:  (1) of any untrue statement, or (2) that the risk was known at the time of the surgery (plaintiff’s expert admitted only extant medical literature was “not germane”).  Rather, plaintiff’s surgeon was the first to report the risk.  Unknown risks are not foreseeable, as required by the state’s product liability act.  Nor did defendant improperly fail to test off-label uses for unknown risks.  Drug manufacturers are not legally required to test their products for unknown risks of off-label uses.  Nor could plaintiff use that unknown risk gin up a claim over truthful off-label promotion.  Assuming that to be an FDCA violation, off-label promotion must be false also to support state-law liability, and the defendant neither knew nor should have known of that risk at the time of the promotion.  Following Caronia (2012+7) and Caplinger (2013+9), Stiens held that mere off-label promotion is not a tort claim under state law.  We saluted Steins here.
  11. (Tie) Ridings v. Maurice, 444 F. Supp.3d 973 (W.D. Mo. 2020). 2020 saw quite a few favorable implied preemption cases involving “newly acquired information,” and this was the best of them.  Extensive analysis, including a road map of how, procedurally, a court is to approach a preemption motion after Albrecht (2019+1, 2019-6).  In Ridings that included a bench trial at which plaintiff had to specify exactly what was supposedly wrong with the defendant’s warning.  “Newly acquired information” is separate from, and precedes “clear evidence” in evaluating prescription drug preemption issues.  Further, it is the plaintiff’s burden to put the defendant in the “clear evidence” box, so plaintiff must come forward with evidence showing that all the prerequisites of the FDA’s CBE regulation are met, not just newly acquired information but that such information involved a “serious” risk.  Good holdings that inconclusive “needs more study” medical articles, foreign warnings, and discontinued patents don’t trigger the CBE regulation.  For good measure, Ridings also found clear evidence that the FDA would not allow the warning plaintiff sought based on FDA inaction in the face of all the information being disclosed and considerable back and forth on the precise topic.  We rapturously reviewed Ridings  (here).

That’s a wrap for our top ten picks as the best drug/medical device decisions of 2020.

But wait; there’s more.  Like the 2020 hurricane season, there were a lot more than ten pro-defense decisions worth naming, so here’s our list of runners up, the next ten most favorable 2020 decisions.

Honorable Mentions:  (11) Zitney v. Wyeth LLC, ___ A.3d ___, 2020 WL 7040432 (Pa. Super. Dec. 1, 2020).  Precedential holding, in hotly contested test case, that no separate duty exists, once a prescription medical product manufacturer has provided adequate warnings with its product, to repeat those warnings in a Dear Doctor letter addressed specifically to a plaintiff’s prescribing physician (here, and here).  (12) This space intentionally left blank.  (13) Hubbard v. Bayer HealthCare Pharmaceuticals, Inc., ___ F.3d ___, 2020 WL 7550285 (11th Cir. Dec. 22, 2020).  Best learned intermediary case of 2020.  Prescriber already knew of risk and thought it too small to change anything.  Georgia does not have a heeding presumption.  Brand new, so no post yet.  (14) Almond v. Janssen Pharmaceuticals, Inc., ___ F.R.D. ___, 2020 WL 6545892 (E.D. Pa. Nov. 6, 2020).  A nationwide class action involving medical monitoring?  No, way.  The multiple conflicting state approaches to medical monitoring alone preclude any class, and justify striking the class allegations at the outset (here).  (15) Irizarry v. Abbott Laboratories, ___ F. Appx. ___, 2020 WL 6441117 (3d Cir. Nov. 3, 2020).  One of the most hotly disputed issues in PMA preemption cases is whether plaintiffs have to plead the nature of the claimed FDCA violation and causation to state a “parallel” violation claim.  In Irizarry the Third Circuit came down on the side of enforcing TwIqbal.  Would have ranked much higher if precedential (here).  (16) Polt v. Sandoz, Inc., 452 F. Supp.3d 557 (E.D. Pa. 2020).  Invokes Erie restraint to reject a novel medication guide exception to Pennsylvania’s learned intermediary rule.  Negligence per se cannot be used to create new duties not recognized by the common law (here).  (17) Henry v. Angelini Pharma, Inc., 2020 WL 1532174 (E.D. Cal. March 31, 2020).  A couple of years ago we had the bright idea that personal jurisdiction was a likely defense to innovator liability, since the defendant never sold the product that the plaintiff took, it did not commit any act in the relevant jurisdiction.  There were no cases then, but in Henry a California court agreed with our theory and dismissed the case (here).  (18) Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020).  Another excellent implied preemption “newly acquired information” decision.  A disorganized mass of some 6000 adverse event reports is not such evidence, hence preemption. (here).  (19) Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889 (M.D. Pa. Aug. 28, 2020).  Dynamite PMA preemption case.  Good on parallel claims, specificity of pleading, failure to report adverse events, and applying Albrecht to medical devices (here).  (20) In re DePuy Orthopædics, Inc. ASR Hip Implant Products Liability Litigation, 953 F.3d 890 (6th Cir. 2020).  A useful appellate reminder that an overseas litigation tourist can’t also sue an overseas defendant, since overseas parties on both sides of the “v.” destroys diversity jurisdiction.  Not more highly ranked because this just doesn’t happen all that often (here).

Our 2020 collection of cases concludes with more near misses than usual – there were quite a few good post-Albrecht preemption cases this year; you can check them all out on our preemption scorecard – so here are the next tier of victories:  Webb v. Mentor Worldwide LLC, 453 F. Supp.3d 550 (N.D.N.Y. 2020) (here), D’Addario v. Johnson & Johnson, 2020 WL 3546750 (D.N.J. June 30, 2020) (here), and Smith v. Teva Pharmaceuticals United States, 437 F. Supp. 3d 1159 (S.D. Fla. Feb. 4, 2020) (here).  Finally, Markham v. Ethicon, Inc., 434 F. Supp.3d 261 (E.D. Pa. 2020), if followed elsewhere, could be a big removal deal (here).

Reviewing our prior lists of best and worst decisions, from this year’s lists, we just discussed the Mirena (2019+9) affirmance above, and mentioned last week, that our #7 best case of 2019 got reversed.  In addition, appeals are pending in Nowell (2019+13) and (we think) in Roberto (2019+20).  The others appear final, with appeals failing to change the result in Sherman (2019+6), Davis (2019+18), A.Y. (2019-3), and Painters & Allied Trades (2019-4).

We skimmed over a couple of earlier years of our top/bottom ten lists, but found nothing more than the Dolin (2018+5) re-affirmance mentioned above and the Russell (2018+17) and Hammons (2018-3) results mentioned last week.

Looking forward, we’ve already mentioned that the Supreme Court will decide, before the current term ends in June 2021, a couple more (non-drug/device) product liability personal jurisdiction cases – ones that do not litigation tourists.  Maybe the decision will provide more clarity about the “arising from”/”relating to” specific personal jurisdiction standard.  We’d like to see further review in the United States Supreme Court of both the Hammons (2020-1) and Russell (2020-2) decisions, since in both instances state highest court refused to follow Supreme Court precedent and relied instead on lone dissents, but Supreme Court review is notoriously hard to get.  Further, an appeal is also pending in the Ridings case discussed above as our number ten case.  Another possibility is that we’ll get lucky, and the Mirena plaintiffs will appeal that case to the Supreme Court.  We think Mirena would be an excellent vehicle for pro-defense resolution of some Daubert-related circuit splits.

Finally, on the administrative front, the biggest action we see on the horizon is whether the incoming administration will let stand the recent expansion of PREP Act liability to actors without government affiliations, decisions not to use covered countermeasures and creating an exclusive federal cause of action.  The FDA’s restarted attempt to address its obsolete, 1950s-vintage “intended use” regulations will also plod forward.

Legislatively, we don’t expect much that affects our product liability bailiwick.  However, that’s not necessarily a bad thing.  With Congress closely balanced, we don’t see much likelihood that legislation precluding snap removals will succeed.

Long ago, when we first started representing the makers of prescription pharmaceuticals, it was said that people did not tend to sue over life-saving medications.  Contraceptives, pain medications, obesity medications, diabetes medications, psychiatric medications, and many others were fair game, even if the risk-benefit calculus for an individual patient might involve major benefits on one side of the scale.  Plaintiff lawyers would not waste their time, it was said, with medications to treat potentially terminal cancer or other conditions that would kill the patient absent effective treatment.  Regardless of whether that old saw was ever true, dockets have been full for a while with cases about medications that are clearly life-saving.  (Some of those plaintiffs also seek to prevent the defendants from properly characterizing their medicines as life-saving, but that is a different matter.)

AIDS used to be one of those conditions that came with a death sentence.  Now, with dozens of medications, often combining different active ingredients, on the market since AZT was approved in 1987, the ability of the medical community to treat HIV, the virus that causes AIDS, is one of the great success stories of medicine.  Dr. Fauci and others from NIAID who have been in the news over the past several months played an important role in this success, but so too have pharmaceutical companies.  Not only can modern treatment regimens keep viral loads below detectable levels and make it so patients with HIV die of old age or unrelated conditions, but the advent of Pre-Exposure Prophylaxis with combinations of medications can prevent transmission in some instances, something unthinkable in the early days of the HIV/AIDS epidemic.

In Epstein v. Gilead Sciences, Inc., No. 19-81474-CIV-SINGHAL, 202 WL 4333011 (S.D. Fla. July 27, 2020) (Singhal, M.J.), these two trends intersected.  The plaintiff claimed to have suffered kidney and bone damages from his use of the prescription drugs Viread and Atripla, a combination of Viread and two other active substances.  In support, he asserted seven different state law claims, including that the drugs were defectively designed because Viread should have had tenofovir alafenamine instead of the tenofovir disproxil as its active ingredient, the drugs never should have been sold, and the drugs should have had different warnings about the risk of kidney and bone damage (of some sort).  This brought us to another trend:  implied preemption of design and warnings claims with branded prescription drugs.  Leading up to and for a while after the terrible Levine decision there was not much hope of getting such design and warnings claims out on preemption, let alone on a motion to dismiss.  But, after Mensing, Bartlett, Albrecht, and a bunch of cases along the way, things have changed for the better.

After noting the plaintiff’s position that “no federal law prevented Gilead from designing its TDF Drugs to be safer before FDA approval and because Gilead could unilaterally change their label to make it stronger to comply with state law” and citing Albrecht, two cases, and the Supremacy Clause, this was the entirety of the Court’s analysis:

Plaintiff’s Complaint is premised on the allegations that:  (1) Gilead should have designed Atripla and Viread with TAF instead of TDF, and thus, never should have sold Atripla and Viread; and/or (2) Gilead failed to adequately warn Plaintiff or his doctors about the bone and kidney risks associated with Atripla and Viread.  Gilead argues these claims are preempted, because Gilead could not have marketed or sold medications containing this design change without first seeking and obtaining FDA approval.  See 21 C.F.R. §314.7-(b)(2)(i) (defining “changes in the qualitative or quantitative formulation of the drug product” as “major changes” that “requir[e] supplement submission and approval prior to distribution of the product”).  This Court agrees, it would have been impossible for Gilead to comply with both its state duties to change the products’ labels and its federal duties not to make such changes without first obtaining FDA approval.  See Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 472, 475 (2013).  Additionally, Plaintiff contends that TAF should have been used instead of TDF; however, the FDA approved Gilead’s formula and any changes would have required further approval.

Id. at *2.  As we said above, short and sweet.  (Not like the path described here.)  Also clearly right on the law.  The narrow CBE exception that Levine latched onto and made something so much bigger did not apply here.  (Peruse these posts, perhaps:  this, this, and this.)  Insisting that a drug should have had a different compound as its active ingredient is not really a design claim, but it definitely requires a few layers of FDA decisions that cannot be taken for granted.  So, plaintiff’s standard product liability claims were preempted.

Plaintiff asserted (and did not drop) state claim claims for fraud, express warranty, and implied warranty.  The Defendant also moved to dismiss those on preemption, but the court only evaluated them on the adequacy of pleading, presumably because of the doctrine of constitutional avoidance.  So, while the preempted claims were dismissed with prejudice, these three were dismissed without prejudice and the plaintiff was given a little time to try to amend.  We do not know yet if he took a second swing, but, if he did, we expect to see another preemption order out of this case.  Preferably, another one that is concise and correct like this one.

 

We’re calling this a “quasi” guest post because the author, Reed Smith‘s Dean Balaes, is actually trying out to join our blogging team.  This is his inaugural post, of what we hope will be many more.  This particular post addresses the causation aspects of a case, Gayle v. Pfizer, Inc., ___ F. Supp.3d ___, 2020 WL 1685313 (S.D.N.Y. April 7, 2020), that we mentioned in yesterday’s preemption post.  As we hope you’ll see shortly, the causation issues in Gayle are also interesting, and favorable to the right side of the “v.”  Without further ado, take it away Dean.

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As is often the case in pharmaceutical product liability actions, another group of plaintiffs’ claims suffered a fatal deficiency:  establishing a causal association between the drug at issue and the alleged injury.  Gayle v. Pfizer, Inc., ___ F. Supp.3d ___, No. 19-CV-3451, 2020 WL 1685313 (S.D.N.Y. April 7, 2020), illustrates this debilitating deficiency when the other side alleged that Lipitor causes Type 2 diabetes by relying on anecdotal adverse event reports.  This blog will provide specific attention and commentary regarding causation fallacies as observed in Gayle, but note that one should also review Gayle for its favorable preemption ruling.

The other side tried to Febreze the air around this malodorous causation reality by relying on 6000 adverse event reports related to an earlier “changes being effected” (“CBE”) labeling change between the defendant manufacturer and the FDA.  The idea was to suggest that the mere existence of adverse event reports related to a drug (without evidence showing a causal association between the drug and the alleged injury) means that the manufacturer knew that the drug categorically caused the disease.  Thus, the Gayle plaintiffs nitpicked the drug’s label change – claiming it only warned about two conditions related to Type 2 diabetes, but should have warned that it causes Type 2 diabetes.

Opposing counsel’s legal gymnastics to hurtle over the fallacy in causation did not work.  According to the FDA, adverse reactions listed in the label are limited to “only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.”  21 C.F.R. § 201.57(c)(7).  After initial FDA-approval, a manufacturer can change labels through the CBE regulation to promote the safe use of the drug product only on the basis of “newly acquired information.”  21 C.F.R. § 314.70(c)(6)(iii).  As the blog’s readers know from scores of preemption posts, the FDA narrowly defines “newly acquired information” as:

[D]ata, analyses, or other information not previously submitted to the [FDA], which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA. 

21 C.F.R. § 314.3(b) (cited at 2020 WL 1685313, at *3) (emphasis added).  FDA imposes this limit for a reason.  “Over-disclosure dilutes warnings of more significant adverse reactions both by likelihood and severity of the reaction and can unjustifiably deter patients from a helpful drug or therapy.”  Id. at *3.

On a motion to dismiss, there is no weighing of evidence yet to prove causation, so Gayle highlights a well- (or at least over-) used plaintiffs’ strategy just to plead some purported evidence – here adverse event reports – and allege that such reports mean that the defendant knew that Lipitor causes Type 2 diabetes.  It is like Senator Hendrickson in the 1954 comic book hearings alleging that reading comic books causes juvenile delinquency.  With no actual evidence proving causality, plaintiffs rely on anecdotal, one-sided, and unverified hearsay (see the blog’s cheat sheet here) such as adverse event reports.  Throw mud against the wall and hope something sticks − either plaintiffs do not have a firm grasp of logical causation, or (more likely) they are hoping judges do not, when all they plead is that there are adverse event reports making the same allegations.

Thus, these plaintiffs erroneously alleged that the 6,000 adverse event reports constituted “newly acquired information.”  Gayle, 2020 WL 1685313, at * 5.  TwIqbal prevailed again, as plaintiffs’ claims were dismissed with prejudice and either barred by the state’s statute of limitations or preempted by federal law (see the blog’s preemption cheat sheet here).  Whether it was one, or 6000, the pleading of adverse event reports were simply vague causation assertions that did not amount to a plausible claim.  See Id. at *5.  As the blog has already discussed, an entire MDL raising the same purported injury against the same drug was dismissed a few years ago for – guess what – failure to establish causation.  Indeed, one would not be at all surprised if the purported 6000 adverse event reports include thousands of plaintiffs from that previous MDL whose claims have already been conclusively adjudicated non-causal.

The fundamentally flawed presumption in the plaintiffs’ causation reasoning is simple:  a phenomenon cannot be proven to occur on the basis of anecdotal adverse event reports.  It is like the child who believes that the song of birds makes the morning happen or the Monte Carlo Fallacy, which makes gamblers believe that a winning streak increases the chances of future winnings.  Alas for plaintiffs, coincidence is not causation.  These plaintiffs’ reliance on adverse event reports did not constitute “newly acquired information” because the reports merely described instances “where patients taking [the drug] were diagnosed with type 2 diabetes, but do not reach any conclusions regarding a causal association.”  Id. at * 6.  Thus, “under a plain reading of the regulations, adverse event reports, without any analysis indicating causality, cannot constitute ‘newly acquired information.’”  Id.

Gayle is worth the read because it is yet one more case (and this is yet one more post) reminding plaintiffs that the mere presence of anecdotal adverse event reports does not necessitate a causal connection based on coincidental relationships. Thankfully, Gayle also shows that judges do understand the fallacies of logical causation.

We’ve noticed quite a few prescription drug preemption decisions lately involving “newly acquired information.”  That’s because the Supreme Court doubled down in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), on the boundary of impossibility preemption being set by a defendant’s ability to utilize the FDA’s “changes being effected” regulation, 21 C.F.R. §314.70(c)(6)(iii)(A), to make certain label changes unilaterally. 139 S. Ct. at 1673.  If a defendant can’t make a CBE change, then it has to get FDA pre-approval for that change, so a state-law claim for not based on not changing the label is preempted under the Mensing independence principle.  You can find all these cases on our post-Levine prescription drug preemption cheat sheet.

While we question the wisdom of having something as important as preemption turn on the complexities of an FDA regulation not intended for that purpose, Albrecht is what it is.  Thus, we’ve been parsing the CBE regulation closely, looking at the prerequisites for its application.  Chief among them is a requirement that a manufacturer possess “newly acquired information” concerning a “clinically significant adverse reaction.”  See 21 C.F.R. §201.57(c)(6)(i) (defining “newly acquired information” for purposes of CBE regulation as concerning an adverse reaction that is either “potentially fatal,” “serious even if infrequent,” or can “be prevented or mitigated through appropriate use of the drug”).  These definitions give our side quite a bit to work with.

Albrecht was decided a little less than a year ago.  Post-Albrecht precedent can’t tell us definitively what “newly acquired information” is, but we can identify with some confidence four things that are not enough.

First, because the information in question must be “new,” when “the undisputed evidence shows that the FDA was aware of the nature of the data it received from” the manufacturer, that data isn’t “new,” even when it is later regurgitated in another article.  Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 815 (7th Cir. 2018) (blogged about here).  In CBE-land, plagiarism cannot preclude preemption.  “[A]ny claim that a drug label should be changed based solely on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.”  In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Product Liability Litigation, 185 F. Supp.3d 761, 769 (D.S.C. 2016).  “New” information must “reveal[] risks of a different type or greater severity or frequency than previously included in submissions to the FDA.”  Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019) (quoting 21 C.F.R. §314.3(b)) (blogged about here).

Thus, the plaintiffs in Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (W.D. Mo. March 16, 2020) (blogged about here), could not avoid preemption where “[b]y and large, nearly all of the ‘newly acquired information’” they relied upon “still relies upon . . . and reflects information – for all intents and purposes – that was provided to the FDA at the time of the initial approval of [the drug] for the American market.”  Id. at *15.  Information that was in essence “previously submitted to the [FDA]” or that “contained the same figures as [defendant’s pre-approval] analysis, which [was] submitted to the FDA” doesn’t become shiny and new again simply because somebody discusses it again later on.  Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452, *18 (Conn. Super. Sept. 11, 2019) (blogged about here).  Accord Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 1890681, at *10 (Conn. Super. March 13, 2020) (reaching same conclusion as Roberto) (blogged about here).

Second, data cannot be “new” when that data did not exist until after a particular plaintiff’s use of the drug was over. “[N]ewly acquired information must have been available to [defendant] after the FDA approved the relevant label on . . ., but before Plaintiff last used [the product].”  Mahnke v. Bayer Corp., 2020 WL 2048622, at *3 (C.D. Cal. March 10, 2020).  “The Court will disregard the many articles cited in the Amended Complaint that were published after [plaintiff’s] last [use of the product].  These studies can have no bearing on her failure-to-warn claim.”  Sabol v. Bayer Healthcare Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2020 WL 705170, at *12 n.13 (S.D.N.Y. Feb. 12, 2020) (blogged about here).

[T[he complaint does not cite any newly acquired information that arose after the FDA’s approval of [the product’s] revised label . . . and before Plaintiff was administered [the product. . . .  Without factual allegations that [defendant] had new information in this time period such that it could have or should have amended the label pursuant to the CBE regulation, the complaint is barred as preempted.

Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019) (blogged about here).

In Ridings, the plaintiff used the drug at issue between early 2012 and mid-2013.  2020 WL 1264178, at *5, 11.  “[S]tudies published after a plaintiff’s injury [are not] relevant to constitute newly acquired information.”  Id. (quoting Roberto, 2019 WL 5068452, at *14).  “Based on [that] reasoning,” Ridings determined that post-use materials could not “constitute even prima facie ‘newly acquired information’” and did not consider that material further.  Id. at *16.  Accord McGrath v. Bayer HealthCare Pharmaceuticals, Inc., 393 F. Supp.3d 161, 170 (E.D.N.Y. 2019) (“this study . . . was published after Plaintiff’s exposure to [the product] and thus cannot support a failure-to-warn claim based on what [defendant] knew or should have known”).

Third, “[c]linically significant” risks must be “‘potentially fatal’ or ‘serious,’ [or have] a ‘significant impact on therapeutic decision-making.’”  Klein v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 3945652, at *5 (D. Nev. Aug. 21, 2019) (quoting 71 Fed. Reg. 3922, 3946 (FDA Jan. 24, 2006)) (blogged about here).  Thus, post-Albrecht case law also rejects inconclusive studies as “newly acquired information.”

[S]tudies concluding that it “remains unknown” whether a drug is linked to a particular adverse reaction or risk or that “further studies are required to address possible clinical consequences” do not constitute reasonable or well-grounded scientific evidence of “clinically significant adverse effects” under the CBE regulation.

Ridings, 2020 WL 1264178, at *15.

McGrath likewise held that “[r]eports and studies that . . . do not reach any conclusions regarding the adverse effects or risks” of a product cannot be “newly acquired information” that could support a going ahead with a CBE warning change.  393 F. Supp.3d at 169 (emphasis original).  “[I]t helps precious little to mount scientific minutiae on top of technical jargon if that information ultimately does not plead a plausible causal association between [the product] and adverse effects.”  Id.  See Sabol, 2020 WL 705170, at *13 (“a tentative, at best, suggestion of a causal relationship” cannot “support[] the inference” of “a clinically significant adverse reaction that would require a manufacturer to change its label”); Adkins, 2020 WL 1704646, at *13 (article’s “rather tentative statement . . . and its conclusion that its proposal . . . ‘lends itself to further clinical trials’ do not establish newly acquired information”).In sum, the “new information” at issue must make out a “a reasonable, if not compelling, causal association” so that the risk at issue “become[s] apparent” as specified by AlbrechtMcGrath, 393 F. Supp.3d at 170-71 (quoting Albrecht, 138 S. Ct. at 1677) (emphasis original).

Fourth, unanalyzed adverse event reports are sufficiently low on the hierarchy of scientific evidence that they “do[] not necessarily reflect a conclusion . . . that the drug caused or contributed to an adverse effect.”  Gayle v. Pfizer Inc., ___ F. Supp.3d ___, 2020 WL 1685313, at *5 (S.D.N.Y. April 7, 2020) (quoting 21 C.F.R. §314.80(l)).

[A]dverse event reports do not constitute “newly acquired information.”  In order to qualify as “newly acquired information,” the information must demonstrate “reasonable evidence of a causal association with a drug.”  But “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.”  The reports describe instances where patients taking [the drug] were diagnosed with [a condition] but do not reach any conclusions regarding a causal association.  Under a plain reading of the regulations, adverse event reports, without any analysis indicating causality, cannot constitute “newly acquired information.”

Id. (quoting Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44 (2011), other citations omitted).  Raw AERs “miss[] the mark,” where plaintiffs “offer no analysis” and “merely proffer the adverse event reports by themselves.”  Id.  Voluntarily collected AERs are such weak evidence that “sheer numbers of case reports . . . reveal little about how frequently the events occur in the broader patient population.”  Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 664 (S.D.N.Y. 2017) (blogged about here), aff’d, 919 F.3d 699 (2d Cir. 2019).  Even “[r]eports and studies that discuss” adverse events are not “newly acquired information.”  McGrath, 393 F. Supp.3d at 169.

We’ve said it before, and we’ll say it again – many (probably most) allegations of causation that we get from the other side are based on pseudoscientific garbage.  With Albrecht mandating that courts, not juries, decide preemption questions, plaintiffs are no longer entitled to the benefit of the doubt, because courts now have to decide “material” factual disputes in the preemption context.  A judge who “simply ask[s] himself or herself whether the relevant federal and state laws irreconcilably conflict,” 139 S. Ct. at 1679, is much more likely to see the garbage for what it is, and to do the right thing.

Not too long ago, our search keyed to Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019), picked up the following article in Trial Magazine:  Abaray & Harman, “Navigating Preemption After Merck,” 56 Trial 20 (Jan. 2020).  For anybody who doesn’t know, Trial is the house organ of the American Ass’n for Justice – the rebranded name for ATLA – and thus a thought leader for the other side of the “v.”

Cognizant of the limits of fair use, we thought we’d provide our views on those arguments.  We’ll start with trivia – we prefer using plaintiff names to describe cases where, as here, there are many cases out there against the named defendant, so we’ll continue calling it Albrecht, except possibly in formal briefing.  That’s the same rule we use for Bauman, Levine, Lohr and a number of other cases we cite frequently where the sides of the “v.” were flipped by the vagaries of the appellate process (usually signifying that the defendant lost in an intermediate appellate court).  Speaking of naming conventions, we’ll refer to the article in this post as “NPAM.”

First off, we agree with the other side that “[a] court’s decision whether state law failure-to-warn claims are federally preempted is a pivotal, sometimes dispositive point in pharmaceutical litigation.”  NPAM, 56-JAN JTLATRIAL 20, at *21 (we’re using Westlaw cites and pagination, since we don’t subscribe).  In fact, for precisely that reason, we’ve supported Lawyers for Civil Justice in its not-yet-successful quest to have certain MDL decisions, including preemption, become eligible for immediate interlocutory review.  As for the Albrecht angle to this, we’ve mentioned before that the Court’s main holding in Albrecht – that preemption is a question of law to be decided by the court – should make the case for interlocutory appeals easier, both before the Rules Committee and under current standards:

[O]ne type of MDL ruling that everyone agrees qualifies as “important” is preemption.  Now that Albrecht has disconnected preemption decisions from factual disputes that require jury resolution, preemption rulings thereby become much more discrete, and thus collateral. . . .  Thus, Albrecht makes it much easier for the defense side to argue that MDL preemption decisions . . . are not only important, but procedurally severable, so as to facilitate interlocutory appeal.

In the same paragraph, and indeed throughout the NPAM article, the authors refer to “impossibility” preemption.  They’re right that Albrecht was an impossibility case, but wrong if they think its holdings are so limited.  In particular, the key holding that made Albrecht our #1 good case for 2019 is that preemption is a legal issue applies to all preemption cases.  That is how post-Albrecht decisions have treated it.  See Delfino v. Medtronic, Inc., 2019 WL 2415049, at *10 (Minn. App. June 10, 2019), review denied (Minn. Aug. 20, 2019) (express preemption case; “the issue of whether [something] constituted a federal requirement is a question of law to be decided by a judge”).  Delfino went on to hold that, given the Albrecht holding that preemption was an issue of law, it was proper to exclude plaintiff’s expert, since experts may not opine on questions of law.  Id. at *12 (“we explained in the preceding section, ‘determining compliance with a regulation . . . is a question of law”; “expert opinion as to a legal matter is generally inadmissible,” so the district court did not abuse its discretion by prohibiting [plaintiff’s expert] from opining on a legal question”).

Even though the Albrecht Court only decided the legal/factual question point, and with it the collateral proposition that there is no heightened evidentiary standard in preemption cases, the majority did reach out and alter the criteria for “clear evidence” of impossibility preemption in cases “like” LevineAlbrecht, 139 S. Ct. at 1678.  Levine (which the Court calls “Wyeth”) had stated:  “absent clear evidence that the FDA would not have approved a change to [the drug’s] label, we will not conclude that it was impossible for [defendant] to comply with both federal and state requirements.”  Wyeth v. Levine, 555 U.S. 555, 571 (2009).  Albrecht turned Levine’s holding into something resembling a multi-part test:

[I]n [Levine], we confronted that question in the context of a particular set of circumstances. . . .  In a case like [Levine], showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.

Albrecht, 139 S. Ct. at 1678.

Almost all of NPAM focuses on various parts of this language – except it ignores the Albrecht majority’s “like” Levine qualifier entirely.  Indeed, the word “like” appears nowhere in NPAM.  That has a number of consequences that we will point out.

NPAM interprets Albrecht as eliminating any consideration of what FDA “would not have” done under the Levine standard.  NPAM, 56-JAN JTLATRIAL 20, at *22.  However, that is only true in cases “like” Levine.  In Levine, there was no claim or evidence that anyone other than the manufacturer had sought any relevant agency decision.  NPAM’s statement that “the manufacturer must have submitted a label change, and the FDA must have rejected it,” id., is thus way overbroad.  For years, pro-plaintiff organizations, usually in connection with litigation, have filed “citizen petitions” with the FDA concerning identical risks and demanding either warnings or to have the drug in question removed from the market.  FDA rulings on such petitions are final agency action.  21 U.S.C. §355(q)(1)(F); 21 C.F.R. §10.30(e)(3) (authorizing publication of the FDA’s decision in the Federal Register).  Citizen petitions also produce “an official administrative record for an FDA decision.”  Albrecht, 139 S. Ct. at 1680.  See 21 C.F.R. §10.30(i) (specifying the “record of the administrative proceeding”).

NPAM’s argument, 56-JAN JTLATRIAL 20, at *25-26, that courts should ignore FDA resolution of citizen’s petitions ignores Albrecht’s “like” Levine qualifier to the discussion of what “manufacturers” submit.  Essentially, plaintiffs are trying to have it both ways – so their fellow traveler organizations (and even plaintiffs’ counsel themselves) can petition the FDA about anything they want with no consequences when the FDA denies their petitions, formally and on the record.  As we’ve pointed out before, post-Albrecht cases involving FDA resolutions of identical issues in citizen’s petitions agree with us.  An on-point FDA ruling on a citizen’s petition is a “set of circumstances with a key difference.”  Cerveny v. Aventis, Inc., 783 F. Appx. 804, 808 n. 9 (10th Cir. 2019); accord State v. Purdue Pharma L.P., 2019 WL 3776653, at *2-3 (N.D. Dist. July 22, 2019).  We also note that, to the extent NPAM advocates serving intrusive discovery on the FDA concerning its internal deliberations, 56-JAN JTLATRIAL 20, at *25, that is unlikely to succeed under United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951).  For more about that, see here.

We also designated Albrecht as our #6 worst case of 2019, and one point NPAM discusses is the primary reason why.  “Lesser steps such as conversations with FDA employees, email exchanges, or internal FDA analyses of scientific data do not establish a federal requirement that can give rise to impossibility preemption.”  Id. at *22.  We think that’s probably correct, except when such “conversations,” exchanges,” or “analyses” produce some “other agency action carrying the force of law.”  Albrecht, 139 S. Ct. at 1679 (citing “e.g., 21 U.S.C. §355(o)(4)(A)”).  This arguable retreat is the primary reason for our designation.  Secondarily, are all the other, bogus arguments that plaintiffs will advance claiming support in Albrecht (in other words everything else in NPAM).

Albrecht stated, “[t]he Supremacy Clause grants ‘supreme’ status only to the ‘the Laws of the United States,’” 139 S. Ct. at 1679 (quoting U. S. Const., Art. VI, cl. 2.), so informal back-and-forth with the FDA by itself wouldn’t seem to qualify.  But preemption motions based on nothing more than that just aren’t very common.  The Third Circuit, for one, closed that door over a decade ago in Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, 250 (3d Cir. 2008) (FDA “advisory and backgrounder” insufficient basis for conflict preemption).

Further, we think the converse is also true.  NPAM points out what falls short of Albrecht are “informal statements are not binding on the FDA.”  56-JAN JTLATRIAL 20, at *22.  Well, plaintiffs in both express and implied preemption situations (especially involving generic drugs) often seek to oppose preemption under “the Laws of the United States” with their own collection of FDA actions lacking the requisite “force of law.”  Albrecht, 139 S. Ct. at 1679.  Two prime examples are FDA warning letters and Forms 483.  This type of argument is particularly common in PMA preemption litigation, where the operation of an express preemption clause (21 U.S.C. §360k(a)), is frequently opposed by purported “parallel” claims also relying solely on “informal statements [that] are not binding on the FDA.”

Also, attention needs to be paid to Albrecht’s citation of §355(o)(4)(A) as an example of “other” preemptive “agency action carrying the force of law”:

If the [FDA] becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug, the Secretary shall promptly notify the responsible person or, if the same drug approved under subsection (b) is not currently marketed, the holder of an approved application under subsection (j).

(Emphasis added).  Note, the reference to “subsection (j)” involves generic drugs.  This regulation cited by Albrecht nicely dovetails with the limitation of the FDA’s so-called “CBE regulation” authorizing unilateral changes to warnings only to” reflect newly acquired information.”  Albrecht, 139 S. Ct. at 1679.  FDA activity pursuant to this statutory power – whether affirmative or negative – should, if sufficiently formal, also support preemption in prescription drug cases.

Since the same “new information” both obligates the FDA to act unilaterally under §355(o)(4)(A) and allows the manufacturer to change warnings unilaterally under the CBE regulation, defendants desirous of the protections of preemption would be well advised to obtain formal FDA no-action letter under §355(o)(4)(A) to avoid the other side’s arguments outlined in NPAM.  NPAM concedes this as a valid reason for preemption, but describes it as “rare,” 56-JAN JTLATRIAL 20, at *23 n.12.  Albrecht provides reasons for our side to ensure that FDA decisions of this sort become much more common.

NPAM also urges plaintiffs to oppose preemption with intrusive discovery into the basis for any FDA’s decision rejecting the warning change at issue:

If the manufacturer establishes that the FDA denied the proposed label change, request discovery of all communications between the defendant and the agency pertaining to the risk at issue, and specifically request the drug manufacturer’s CBE or PAS submissions asking for the label change.

56-JAN JTLATRIAL 20, at *23.  That presents an obvious conflict with Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as the article anticipates.  Id.  To argue that “Buckman should not be an obstacle to challenging a drug manufacturer’s deficient submissions to the FDA,” NPAM, 56-JAN JTLATRIAL 20, at *24, relies on the highlighted portion of the following discussion:

[I]f the FDA rejected a drug manufacturer’s supplemental application . . . on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it.  Yet in litigation between a drug consumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision), the litigants may dispute whether the drug manufacturer submitted all material information to the FDA.

Albrecht, 139 S. Ct. at 1680.

The excerpt was from a discussion of why preemption is a legal, rather than a fact, question, and the Court doesn’t mention, let alone distinguish, Buckman.  Thus, it hardly stands for ignoring a unanimous Supreme Court decision.  It’s not the “litigants” who decide whether the FDA was fully informed.  Rather, under Albrecht, “the FDA, and only the FDA, can determine what information is “material” to its own decision to approve or reject a labelling change.”  In re Avandia Marketing, Sales & Products Liability Litigation, 945 F.3d 749, 759 (3d Cir. 2019) (emphasis original).  The obvious alternative is to ask the FDA.  We addressed the relationship between Albrecht and Buckman in more detail, here.

This can be done in several ways.  First, courts of the view that “only the FDA” can make the requisite determination could apply the doctrine of primary jurisdiction, which as we’ve discussed elsewhere, is the most reliable means to ensure that the FDA has requisite opportunity.  We haven’t seen a post-Albrecht decision addressing primary jurisdiction, but it’s the strongest option short of preemption itself to preserve the FDA’s decision-making power.  Second, as we discussed earlier in this post, another way is via citizen petition.  That was done recently in the Zofran, MDL, with the MDL judge telling the FDA he would express “no view as to the merits,” while urging the agency to “make its decision based on the relevant scientific and medical criteria, and according to the law, without regard to its potential impact on the litigation,” and to do so “without undue delay.”  Public letter to FDA, Zofran MDL PACER Docket #1773 (D. Mass. Dec. 13, 2019).

The NPAM article mentioned a third option, seeking an FDA amicus brief, something courts do from time to time (the last request we’re aware of happening in Albrecht itself).  The simple fact that the Supreme Court did precisely this in Albrecht substantially undercuts NPAM’s argument that FDA amicus briefs on “clear evidence” preemption questions:

[A]sk[] the court and the FDA to speculate about what the agency would have done in a counterfactual world in which the drug manufacturer fully informed the FDA.  Based on [Albrecht], such speculation has no place in a preemption analysis.

56-JAN JTLATRIAL 20, at *24.  This argument makes little sense.  First, courts routinely ask the FDA for amicus briefs in preemption cases, and even find such briefs persuasive in other cases.  E.g., Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 774-75 (3d Cir. 2018) (relying on requested FDA amicus brief in preemption decision); Williams v. Mentor Worldwide LLC, 2019 WL 4750843, at *6 (N.D. Ohio Sept. 30, 2019) (preemption decision citing FDA amicus brief in prior case); In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 401 F. Supp.3d 538, 552, 554 (D. Md. 2019) (same as Williams, citing Shuker FDA amicus brief multiple times).  Second, there is nothing “counterfactual” or “hypothetical” about asking the FDA to state whether or not a specific decision that it has already made was “fully informed,” in light of whatever additional material the plaintiffs have brought forward.  This particular argument is based on one thing – plaintiffs’ fear of the prerequisites for preemption being decided by an independent, unbiased decision maker.

Finally, we’d like to point out all the preemption-related arguments NPAM avoids mentioning.  First and foremost, NPAM stays away from express preemption in PMA medical devices, as well as generic drug preemption.  As we’ve mentioned, the conclusion that preemption is a “legal question” and its emphasis on FDA decisions with “force of law” will have (and has already had) significant beneficial effects for defendants in all preemption cases:  (1) thumbs are now off the evidentiary scale – as we’ve discussed, the judge “simply ask[s]” who has the better of the argument, 139 S. Ct. at 1679; (2) precluding of expert testimony on questions of law; (3) Albrecht’s reiteration of the FDA’s CBE regulation as the basis for avoiding preemption, id., reinforcing the other, CBE-related bases for preemption, such as “newly acquired” information and other exceptions to that regulation; (4) Albrecht’s omission of any mention of a “presumption” against preemption from its restatement of Levine; (5) recognition of “overwarning” as a policy concern, id., at 1673 (“exaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it”); and (6) better arguments for interlocutory review.  There are good reasons we awarded Albrecht the # Best decision of 2019 that NPAM has no response to, and therefore remains mum.

We’re not just blowing smoke.  It’s still quite early, but we’ve already seen post-Albrecht decisions discussing overwarning.  McGrath v. Bayer HealthCare Pharm. Inc., 393 F. Supp. 3d 161, 169 (E.D.N.Y. 2019); Klein v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 3945652, at *5 (D. Nev. Aug. 21, 2019).  Several courts have applied the “new evidence” limitation to the CBE exception and ruled in favor of preemption.  McGrath, 393 F. Supp.3d at 171; Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019); Pradaxa Cases, 2019 WL 6043513, at *3-4 (Cal. Super. Nov. 8, 2019); Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452, at *13 (Conn. Super. Sept. 11, 2019).

Welcome to our annual Elysium tour, in which we electronically acknowledge the sweet nectar of victory flowing from the top ten drug/device product liability decisions of the year.  It’s time to salute those fortunate decisions that brought the judicial Midas touch to our clients’ cases.  We echo what we said last year:  “we’re looking for nothing but pleasant news . . . [a]nd make no mistake about it, there’s plenty to celebrate this year.”

Occasionally, a court will do something decidedly anti-Dionysian, with an eleventh-hour awful decision (the infamous Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), was decided two days before Christmas), but barring that, we’re expecting pleasant dithyrambs from 2019’s paragons of judicial reasoning.

Before the Great Panathenaia begins, we remind readers that our scope of coverage is limited.  Our top (and bottom) ten lists are limited to cases involving prescription medical product liability litigation (relatively broadly defined).  Cases are decided each year that significantly impact what we do, even though not involving prescription medical products.  So, we’ll tip our collective pilei to In re Amendments to the Florida Evidence Code, 278 So.3d 551 (Fla. 2019) (discussed here), not really a “case” at all, but a monumental step forward for Florida law – adopting a Daubert-based standard for admissibility of expert witnesses.  Kudos also to two talc wins, State ex rel. Johnson & Johnson v. Burlison, 567 S.W.3d 168 (Mo. 2019) (discussed here), granting mandamus to disapprove venue abuse in St. Louis; and Johnson & Johnson Talcum Powder Cases (Echeverria), 249 Cal. Rptr. 3d 642 (Cal. App. 2019) (discussed here), j.n.o.v.ing several parts (including punitive damages) of an absurd $400+ million verdict and granting a new trial as to the rest due to inadequate causation evidence.  Also noteworthy is Fitzpatrick v. Wendy’s Old Fashioned Hamburgers, ___ N.E.3d ___, 2019 WL 5792847 (Mass. App. Nov. 7, 2019) (discussed here), the first express appellate condemnation of plaintiff-side “reptile” tactics.  Finally, we recognize American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (discussed here), for holding that the First Amendment precludes governmental mandate of a controversial “safety” statement in product advertising.

Enough with the introductions.  Now, let’s proceed with the panegyrics.

  1. Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  Even though Albrecht has enough aspects we don’t like to be named simultaneously as our sixth worst case, the Court’s disposition of the core preemption issues promises to be so beneficial to all defendants that Albrecht is also our number one best case for 2019.  Already, it wiped out our worst case of 2017, as well as two decisions that otherwise might have made this year’s bottom ten.  The impact of Albrecht’s holding that preemption is always a question of law for the court – including resolution of any subsidiary factual disputes – should have numerous beneficial effects.  The Third Circuit’s ill-fated “clear and convincing evidence” standard likewise vanished with the “question of fact” misnomer, and with no facts for juries to decide, the summary judgment “most favorable to nonmovant” standard for viewing facts also drops out (it hasn’t applied in analogous patent litigation).  Albrecht thus removed pro-plaintiff thumbs from the evidentiary scale in preemption cases.  In 95% of preemption cases (at least), we think defendants have the better side of the regulatory record, thus we should win most straight-up preemption arguments.  Courts can no longer cop out, or kick the can down the road, with the excuse of “disputed” facts.  Since expert testimony on questions of law is improper, obfuscation of preemption issues by paid “FDA experts” should lessen.  Also, with preemption as a discrete legal issue, separate from trial, arguments for interlocutory review of adverse preemption decisions improve (although judicial factual determinations, where present, may well get appellate “clearly erroneous” deference).  These points improve defense chances in all preemption cases, implied or express, since a level playing field should also greatly assist defeating FDCA intensive “parallel violation” claims in PMA preemption cases.  Other useful points include the Court’s first discussion of “overwarning” as a policy concern.  Albrecht omitting any “presumption” about preemption in its extensive Levine (2009-1) discussion, instead using only the older “assumption” language.  The last vestiges of the so-called “presumption against preemption” are now in doubt.  Albrecht also doubled down on the FDA changes-being-effected (“CBE”) regulation defining Levine’s safe harbor against impossibility preemption, which creates preemption arguments for everything that CBE doesn’t cover.  Even the reformulated FDA “fully informed” gloss on Levine “clear evidence” opens the door to the FDA itself answering that question (see the above 95% reference).  Likewise, the decision’s discussion of “force of law” also cuts both ways, and should restrict plaintiffs’ ability to rely on warning letters and other FDA actions lacking the required legal status.  Since preemption is the strongest defense our side has, all these favorable holdings and implications make Albrecht our number one decision for 2019.  We analyzed Albrecht on multiple occasions, most notably here and here, and will undoubtedly do so again.
  2. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019).  Gibbons is a two-fer.  Its preemption ruling is extremely helpful – affirming in all respects the district court’s extensive and expansive preemption rulings based, not on Levine (2009-1) clear evidence, but on the “newly acquired information” limitation in the FDA’s CBE regulation.  Those rulings showed the strength of “newly acquired evidence” as a separate preemption basis, enough to be our top district court decision in 2017Gibbons also confirmed that Mensing (2011+1)/Bartlett (2013+1) preemption is indeed of universal applicability, and not limited (as plaintiffs argued) to generic drug cases.  Thus, whenever FDA pre-approval is required for a given alteration in the design or warning of a drug (or device), the Mensing independence principle mandates preemption.  Gibbons also confirms the value of TwIqbal in preemption cases, upholding preemption where plaintiffs failed to plead any “newly acquired information” that could get them into Levine’s CBE preemption safe harbor.  Gibbons demonstrates the power of preemption – an entire MDL went down to defeat.  That’s one.  The second part of Gibbons strongly confirmed that defendants can properly remove cases to federal court before service of process on a “forum defendant” that would otherwise prevent removal.  That’s what the statute said, so that’s what defendants can do.  Litigation tourist plaintiffs have exploited the archaic “forum defendant rule” to create mass torts in their favored locales, even though their target defendant is otherwise diverse and would be exposed to pro-plaintiff “home cooking” in such places.  For handing defendants wins in both preemption and removal, Gibbons comes in second only to a Supreme Court decision.  We goggled over Gibbons here.
  3. Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. 2019).  Preemption, again.  Hey, it’s our strongest defense.  In this pre-market approval case, the plaintiff sought to prove the FDCA violation necessary to support a “parallel violation” claim on what amounted to res ipsa loquitur – asserting that a device malfunction allows the inference, not just of a product defect, but of a regulatory violation (but don’t ask the plaintiff what it was).  Weber became the first appellate court to hold that plaintiffs can’t do that.  Res ipsa loquitur may allow inference of a product defect, but not a violation of any particular regulation.  Instead, to avoid preemption, a plaintiff must show that the defendant device deviated from the device’s pre-market approval requirements or some other applicable FDA standard.  The FDA approves devices knowing they can malfunction.  Since full compliance can’t eliminate malfunctions, no inference of regulatory violation from a mere malfunction is possible.  A secondary, and helpful, ruling in Weber was that a factual description of clinical trial results did not create any express warranty that every device would always perform within that description.  Such a mandatory guarantee was “different from” applicable FDA requirements, and thus also preempted.  We welcomed Weber here.
  4. In re 3M Bair Hugger Litigation, 924 N.W.2d 16 (Minn. App. 2019).  The appellate decision that put an end to the Bair Hugger litigation rates as our best state-court decision of 2019.  The opinion described what we called the “Dostoyevskian” origins of the litigation, stirred up by the jilted inventor of the device, who left the company under a legal cloud, invented a competing device, and then tried to use this product liability litigation as a tool either to obtain a competitive edge or to force the defendant to buy his company.  Suffice it to say, that it did not end well for plaintiffs – particularly since the FDA disagreed with the inventor’s supposed “scientific” study of comparative device safety.  Of course, the thrice-jilted inventor also served as plaintiffs’ expert in the litigation.  Minnesota doesn’t follow Daubert, but in Bair Hugger that hardly mattered.  The novel scientific theory touted by plaintiffs and their expert wasn’t generally accepted, so all the Bair Hugger claims failed on causation grounds.  The best legal ruling in Bair Hugger was that the Frye test (Minnesota’s version, anyway) applied to both methods and to ultimate opinions.  In other words, even when an expert is devious enough to manipulate accepted methods to reach a crazy result, the craziness of the result is sufficient to require exclusion.  We gave Bair Hugger a big hug here.
  5. Robinson v. Davol, Inc., 913 F.3d 690 (7th Cir. 2019).  Robinson was our best Rule 702 decision of the year.  Plaintiff had a medical device – later recalled – implanted.  Plaintiff also died from after implantation of the device.  Plaintiff’s problem was that the two didn’t relate to each other.  The recall did not involve any risk pertinent to the the decedent’s death.  Plaintiffs’ three experts tried, but failed.  The first simply wasn’t competent to make such a diagnosis.  He was a “biomedical engineer” but didn’t know the medical issues surrounding the death.  The second, the coroner who performed the autopsy, and later hired as a plaintiff-side expert, was properly excluded on the procedural ground of not being timely disclosed as a retained expert, since those opinions went beyond the autopsy.  The third expert made up a novel causation theory, but had no pre-existing science to support his ipse dixit.  He claimed to have seen it happen in his other patients, but refused to identify the patients or produce relevant medical records.  Nor did the decedent’s medical records or autopsy contain any support.  The Seventh Circuit found that opinion the paradigm of unreliability.  No “differential diagnosis” worthy of the name was conducted, because the expert lacked any basis for ruling in the device as a possible cause.  We recommended Robinson here.
  6. Sherman v. Pfizer, Inc., 440 P.3d 1016 (Wash. App. 2019).  Mostly because of preemption, we don’t run across many product liability decisions involving generic drugs anymore.  Sherman points out other reasons, besides preemption, why this is so.  All of the usual inadequate warning claims would have been preempted (or might have been in the trial court; we can’t tell) so plaintiff appealed duty-to-update allegations and a claim that warnings should have been given “in ways other than the package insert.”  Didn’t work.  Turns out the prescriber didn’t rely on package inserts for drug risks at all.  Preemption or no, non-reliance on an allegedly inadequate warning kills causation.  Preemption probably would have taken out the “other ways” claim, but a quirk of the Washington product liability statute got there first.  Warning claims by statute are limited to material “provided with the product.”  The statute says what it says, so non-label-based claims don’t fly in Washington state.  We saluted Sherman here, and, the Washington Supreme Court has since denied review.  2019 WL 6682200 (Wash. Dec. 5, 2019).
  7. In re Genentech, Inc., Herceptin (Trastuzumab) Marketing & Sales Practices Litigation, 367 F. Supp.3d 1274 (N.D. Okla. 2019).  As was the case last year with Gustavsen (2018+2), garbage, no-injury class actions claiming dosage-related economic losses tend to produce favorable rulings.  The product, a biologic, cannot be easily produced (if at all) in exactly identical units, so the FDA approved it for marketing within plus-or-minus weight tolerances around a specified midpoint.  Plaintiffs claimed (in a class action, of course) that anything less than the specified midpoint shorted them out of valuable product.  That’s the opposite of the aforementioned Gustavsen case, where too-large doses allegedly wasted valuable product.  But the result was the same – preemption.  First, FDA regulations specifically permitted “reasonable variation in dose, creating a direct, and preemptive, conflict.  Second, plaintiffs could not challenge the FDA classification of the product.  Third, a “draft guidance,” particularly one after-the-fact, did not create any enforceable FDA requirements that could be violated.  Third, plaintiffs misinterpreted an FDA compliance guide to invent an exact dosage number that did not, in fact, exist.  Finally, to comply with plaintiffs’ demands for exact dose would require a change in manufacturing processes requiring prior FDA approval, meaning preemption under the Mensing (2011+1) independence principle.  We note that Genentech is currently on appeal, and given the numerous FDA-related arguments, our side of that appeal should be helped by Albrecht’s ruling that judges simply decide, straight up, which side is correct on preemption issues.  We grooved on Genentech here.  The district court’s decision is currently on appeal.
  8. Greager v. McNeil-PPC, Inc., ___ F. Supp.3d ___, 2019 WL 5549524 (N.D. Ill. Oct. 28, 2019).  Historically, generic preemption has been very extensive, whereas the role of preemption in over-the-counter (“OTC”) drugs has been rather more limited.  Thus, a lot of liability potentially depends on which side of that line generic OTC drugs fall.  This question of first impression was answered in Greager, and its application of generic preemption is good news for any potential defendant manufacturer of generic OTC products.  The drive-a-truck-through exception to OTC express preemption in the FDCA doesn’t affect application of generic preemption, because Mensing (2011+1)/Bartlett (2013+1) preemption is based on implied impossibility preemption.  Implied and express preemption operate independently, meaning that the express saving clause (which is limited to “this section” in any event) doesn’t restrict the wide scope of implied generic preemption.  The duty of sameness applies to OTC as well as prescription generics.  For this potential impact on litigation over an entire class of drugs, Greager makes our list.  We gloried in Greager, here.
  9. In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 387 F. Supp.3d 323 (S.D.N.Y. 2019).  Simply the name of the injury plaintiffs were claiming in this latest tort-based assault on contraceptive choice indicates severe Daubert problems ahead – “idiopathic intracranial hypertension.”  “Idiopathic” means an unknown cause.  And that’s what happened.  In 2018, the Daubert hammer came down on these claims, in a decision that was the first of our honorable mentions that year.  But in an MDL, plaintiffs never give up no matter how weak their position.  So despite all their experts being excluded, they claimed that they could prove that the drug caused “idiopathic” injury without any experts at all.  Mirena held that argument was just as dumb as it sounded to us.  Reviewing the law of all 50 states, Mirena found that, without exception, this kind of technical causation issue absolutely required expert support.  Further, general causation was a requirement for all tort claims.  As for the rather disorderly mess of non-expert “evidence” that plaintiffs claimed could prove causation, that “end run” was simply “unsustainable.”  Last and least, plaintiffs’ Seventh Amendment challenge to an MDL-wide ruling was rejected.  MDL Daubert decisions are a two-way street, a plaintiff loss has the same litigation-wide scope that plaintiffs claim when they win.  We not only made much of Mirena, here, but Mirena inspired us to create our own 50-state survey of expert-required causation decisions here.
  10. Forrest Laboratories v. Feheley, 2019 WL 5485548, __ So.3d __ (Ala. Oct. 25, 2019).  What is our only state high court decision in the top ten doing way down here?  Because, frankly, the result should have been obvious.  As we discussed at the time, in 2015 the Alabama legislature statutorily abolished the misguided innovator liability theory that a divided Alabama Supreme Court had created the year before in Weeks (2014-1).  This statute even timed its effective date to match with the very day that Weeks was decided.  So, of course, plaintiffs claimed that this statute either hadn’t, or couldn’t abrogate Weeks.  In Feheley that Alabama Supreme Court held that, yes, the legislature had actually abolished innovator liability.  Not surprisingly, this result was mandated by “the plain meaning of the words as written by the legislature.”  Plaintiffs’ last-ditch constitutional argument also failed.  Thus, the same court that decided Weeks accepted that its ruling had been overturned by the legislature as a co-equal branch of government.  That’s great, but the legislative intent was so obvious that plaintiff should have been laughed out of court rather than being able to appeal all the way to the state’s highest court.  We focused on Feheley here.

So these are our top ten picks as the best drug/medical device decisions of 2019.  While our list seems preemption heavy (4 of 10), that’s actually no different than 2018 or 2017.  Our picks reflect the simple fact that, where preemption exists, there is no stronger defense.

But we’re not done.  2019 was another good defense year (aside from opioids, which we can’t discuss for client reasons), so we found more than ten deserving decisions.  Thus, here are our runners up, the next ten good 2019 decisions that didn’t quite crack our top ten.

Honorable Mentions:  (11) Cerveny v. Aventis, Inc., 783 F. Appx. 804 (10th Cir. 2019), ended litigation that produced top-ten decisions in 2017 and 2016, holding that a claim about pregnancy warnings didn’t make any sense where the plaintiff only took the drug before being pregnant − with the added bonus of rejecting the post-Albrecht argument that preemption can’t be based on citizen petitions filed by non-manufacturers (here).  (12) In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 358 F. Supp.3d 418 (E.D. Pa. 2019), demonstrates how personal jurisdiction can win cases, even where the plaintiffs aren’t litigation tourists (here).  (13) In Nowell v. Medtronic Inc., 372 F. Supp.3d 1166 (D.N.M. 2019), the same judge who had, several years earlier, questioned the learned intermediary rule under New Mexico law resoundingly reaffirmed the rule’s application (here and here).  (14) Delfino v. Medtronic, Inc., 2019 WL 2415049 (Minn. App. June 10, 2019), would probably cracked the top ten had it been published, due to its first-in-the-nation post-Albrecht appellate ruling that FDA experts aren’t needed to decide “legal” preemption issues.  The defendant won because plaintiff’s purported “violations” misconstrued FDA regulations (here).  (15) Ideus v. Teva Pharmaceuticals USA, Inc., 361 F. Supp.3d 938 (D. Neb. 2019), rejected contraceptives and direct-to-consumer advertising as exceptions to Nebraska’s learned intermediary rule, and held the defendant’s warnings adequate as a matter of law (here).  (16) Powers v. Merck & Co., 773 F. Appx. 304 (6th Cir. 2019), exemplifies how the Vaccine Act has killed off vaccine-related litigation, ruling that an intentionally added substance cannot be a “contaminant” (here).  (17) Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152 (E.D. Cal. 2019), landed a one-two punch – first, the manufacturer’s warning was adequate as a matter of law, and second, since it was impossible for mere distributors to alter drug labels, preemption barred those claims (here).  (18) Davis v. McKesson Corp., 2019 WL 3532179 (D. Ariz. Aug. 2, 2019), demonstrates that, for Rule 702 reasons, the other side’s second assault on gadolinium contrast agents will be much less successful than the first (2010-5) (here).  (19) In McNeil-Williams v. DePuy Orthopaedics, 384 F. Supp.3d 570 (E.D.N.C. 2019), another court rejected the Stengel (2013-2) proposition that ordinary inadequate warning claims are somehow “parallel” to novel failure-to-report claims.  No such claim exists in North Carolina (here).  (20) Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 4806271 (Conn. Super. Sept. 11, 2019).  The best state trial court decision of the year.  While ostensibly affirming this particular plaintiff’s verdict, it thoughtfully held that the claims most plaintiffs pursue in this mass tort are preempted, for the same “newly acquired information” rationale discussed, above, in Gibbons (here).

Our 2019 collection of cases concludes with a couple of near misses:  Hindermyer v. B. Braun Medical, Inc., ___ F. Supp.3d ___, 2019 WL 5881073 (D.N.J. Oct. 30, 2019) (here), and Kelsey v Alcon Laboratories, Inc., 2019 WL 1884225 (Utah Dist. April 22, 2019) (here).

Reviewing our prior lists of best and worst decisions, as already mentioned, the Supreme Court in Albrecht vacated the worst case of 2017, In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  Recently the Third Circuit remanded the preemption issue to the trial court, so we’ll be watching what happens.  More generally, we’re pleased to report that of our thirteen previous worst cases of the year (2017 had two), almost half are no longer good law, by reason of outright reversal (2017-1; 2016-1; 2012-1), legislative abrogation (2014-1; 2007-1), or being limited to their facts by subsequent rulings (2010-1).  By contrast, all twelve of our annual best cases are still good law.

From this year’s lists, A.Y. (2019-3) is the subject of a pending reargument petition in the Pennsylvania Superior Court.  From last year’s lists, on the dark side, Hammons (2018-3), has an appeal pending before Pennsylvania Supreme Court.  All of those other rotten tomatoes appear to be final, at least on direct appeal.  All of 2018’s top ten also seem to be concluded, with denial of certiorari in Dolin (2018+5).  There is more activity, however, among the honorable mentions, as discussed above, Mirena (2018-11) will undoubtedly be appealed.  An appeal to the Kentucky Supreme Court has been granted in the Russell (2018+17) IDE preemption case.  Further appeal was denied in Caltagirone (2018+16), another preemption case, and an appeal was withdrawn in Byrd (2018+19).  The others appear final.

As we thought last year at this time, the cy pres Supreme Court appeal in Frank v. Gaos turned into a rather good standing decision.  See Frank v. Gaos, 139 S. Ct. 1041 (2019).  The cy pres issues remain unresolved.

A quick and dirty review of the last few years of our earlier top/bottom ten lists found nothing suggesting further appeals or other consideration of the resolutions reached in those cases.

Looking forward, we know that an appeal from the adverse post-Safe Medical Devices Act §510(k) preemption decision in In re Bard IVC Filters Products Liability Litigation, 2017 WL 5625547 (D. Ariz. Nov. 22, 2017), is pending in the Ninth Circuit.  A win would have a huge upside – recognizing express 510(k) preemption on the basis of the 1990 rewriting of the Medical Device Amendments – whereas a loss would leave our side basically where it is now.  Closer to home, the Pennsylvania Supreme Court has a significant non-prescription medical product expert evidence decision pending (Walsh) on theories that could create some version of industry-wide liability.  Pennsylvania Superior Court has a pending appeal (Emmet) on comment k and medical devices, as well as a pending non-prescription medical product en banc appeal (Murray) on corporate registration to do business as “consent” to personal jurisdiction.  Bexis has filed amicus briefs in all of those appeals.

Finally, on the administrative front, we still haven’t seen any real FDA movement on its long-delayed promise to address the First Amendment obsolescence of its 1950s-vintage “intended use” regulations.  Nothing concerning off-label use issues appears in the FDA Commissioner’s recent comprehensive remarks on the direction of the Agency.  It appears, however, that the FDA itself has decided to go into the business of truthful promotion of off-label use.  The FDA also released, last September, a “Medical Device Safety Action Plan,” available here.  An interesting aspect of this plan is the National Evaluation System for health Technology (“NEST”), which is intended “to be an active surveillance and evaluation system.”  Id. at 6.  That should be one more nail in the coffin of claims predicated on failure to report, since if something’s serious, the FDA will probably learn about it (and thus be statutorily required to act, 21 U.S.C. §355(o)(4)(A)) independently of any reporting of adverse events.

Legislatively, there is a lot of talk about “high drug prices,” but whether that will actually result in legislation is questionable.  We think that any legislation should address the high and increasing “tort tax” that all the litigation we write about is imposing on prescription medical products.  All those crazy verdicts that we see – from Philadelphia, St. Louis, California, and elsewhere – would (if they stand up on appeal) only be satisfied by higher prices for all of the targeted defendants’ products, and the same goes for MDL settlements and litigation costs.

 

Sort of like hail in Alabama.  It happens, but when it does it’s an event.  Not like say picking a perfect NCAA March Madness bracket (1 in 2.4 trillion).  Maybe more like the chance of getting struck by lightning in a lifetime (1 in 13,000).  In any case, a California trial court decision finding no warning causation under the learned intermediary doctrine caught our attention as newsworthy.  The case is one of the coordinated Pradaxa Cases, Case No. CJC-16-004863 (Cal. Super. Nov. 8, 2019) (Lawson, CGC-17-559611), slip op.

Plaintiff was prescribed Pradaxa in late 2010 to treat her atrial fibrillation.  Id. at 2-3.  Her prescribing physician testified that at the time he prescribed Pradaxa to plaintiff he was aware that it carried a risk of significant bleeding, which risk was increased in female patients over the age of 75, which plaintiff was.  Id.  The prescriber also testified that he informed plaintiff of these risks.  In 2016, plaintiff suffered an intracranial hemorrhage.  She was administered the Pradaxa reversal agent and was stabilized.  Id. at 4.    Defendant moved for summary judgment on plaintiff’s claims for failure to warn, fraud, and misrepresentation.

We’ve seen these cases elsewhere before – no warning causation where doctor knew of the very risk (and in this case warned of the risk) that materialized.  But, again this is California.  The court pointed out that neither party cited any California cases to support their arguments on warning causation.  There was no binding precedent.  Id. at 8n.9.  What the court did find persuasive in this instance is the level of speculation needed on all sides to find causation – a level to which the court was unwilling to go.

First, plaintiff could not testify that she definitely would have changed her mind if provided additional risk information.  At best she said she “probably” would have refused or “might” have said no.  That’s not enough.  Id. at 4n.5.

Second, the prescribing physician, after being shown “various medical literature, references to [manufacturer] company documents, and regulatory documents,” testified that he stood by his prescribing decision.  The additional information would not have changed either his decision to prescribe Pradaxa to plaintiff or his informed consent discussion.  Id. at 5.  “This evidence is sufficient to demonstrate that Defendant’s alleged failure to warn did not proximately cause Plaintiff’s injury.”  Id. at 9.

What plaintiff clung to was her physician’s testimony that he would have liked to have known if there was a mechanism to monitor/measure a patient’s Pradaxa levels and that he would have measured the levels to see if there was a risk of a major bleed.  Id. at 5.  Plaintiff used this testimony to attempt a factual leap of causation.  If the doctor had known he could measure Pradaxa levels, he would have.  And if he did, he would have discovered her elevated levels and reduced her Pradaxa dosage or changed her medication to a different anticoagulant.  Id. at 9.  But the prescriber’s testimony only supports that he would have measured plaintiff’s levels, not whether those measurements would have caused him to alter courses.  In other words, [p]laintiff’s theory for proximate causation is speculative.”  Id.

The speculation could not be saved by a retained expert’s opinion.  Plaintiff’s expert testified that the elevated levels of Pradaxa in plaintiff’s blood “more likely than not caused her intracranial bleed.”  Id. at 11.  But warning causation is about the learned intermediary, not an outside expert:

However, regardless of [plaintiff’s expert’s] opinions, what matters to the causation inquiry in this case is [the prescriber’s] opinion, that is, as the learned intermediary, whether [the prescriber] would have changed his course of treatment or provided different warnings to Plaintiff.

Id. That evidence simply did not exist and that “absence of evidence” was fatal to plaintiff’s case.  Id. at 12.

Plaintiff’s last effort to save her case was to argue that because her prescribing physician testified that he may have changed some of his conduct if provided different information she had met her burden of proof.  But plaintiff did not frame the legal question correctly.

Upon a review of the case, the legal inquiry on causation is not, as Plaintiff suggests, whether the prescribing physician would have changed his conduct of the manner in which his [sic] would have prescribed the drug if he had received the warning or risk information of which he was unaware at the time.  Such a standard is too broad.  Rather, the change in a physician’s conduct or prescription procedures must have sufficiently prevented the Plaintiff’s injury, and/or be sufficiently connected to the injury.

Id. at 14 (citations and quotation marks omitted).  In other words, to defeat summary judgment, any change in the prescribing physician’s conduct must have been causally related to the alleged injury.  All doctor’s want to know more.  That is not enough to create a triable issue of fact.  Id. at 15-16.  Doctors get new information all the time that has no impact on their prescribing decisions.  To establish causation, the doctor must testify that he would have wanted to know and he would have done something differently that is related to the actual injury plaintiff suffered.  A possibility of a change in conduct is likewise insufficient – “might” or “may” are not enough.  Id.

The lack of warning causation was fatal to all of plaintiff’s warning-based claims and summary judgment was granted.  This might not be a blue moon (1 every 2.7 years) or a shark attack on a human (1 in 3.7 million).  It may not even be the only favorable California trial court decision we blog about this week.  But just because you find more than one four leaf clover in the same field doesn’t make it any less remarkable.  Who knows when the next one will come along?