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.
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.
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) 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 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. 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., 128 S. Ct. 999 (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, 129 S. Ct. 1187 (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 still 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.
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.
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.
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.
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.
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.
Originally Published by Smith, January 2021
This article is presented for informational purposes only and is not intended to constitute legal advice.