For a few years, it seemed like we were blogging about the Weeks case every few months.  Beyond providing an opportunity for temporal quippery, Weeks caught our attention because it was one of the holdout cases against the tide of cases rejecting Conte, the crappy California case that invented innovator liability.  After the Alabama Supreme Court recognized that nefarious doctrine (and some federal courts had started to limit its holding), the Alabama legislature stepped in and enacted the following:

In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product. Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury. A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.

The connection between that act and the Weeks decision was pretty darn clear.  Since then, Alabama cases have been pretty quiet when it comes to attempts to impose liability on a drug company that did not make the drug consumed by the plaintiff seeking to recover.

There is always another fact pattern to test what might seem like settled law—even what the settlement comes from a determined legislature—and that brings us to Forrest Labs. v. Feheley, No. 1180387, 2019 WL 5485548, __ So.3d __ (Ala. 2019).  The facts of this case are so tragic that they make us think of the aphorism that “bad facts make bad law.”  They also make us think that desperate plaintiffs will find someone to sue and something to sue about, which is not quite so pithy.  An individual was prescribed an antidepressant by his doctor and filled it the same day with a generic version made by company X.  The next day, maybe before he started the drug, he fatally shot his estranged wife and then killed himself.  Her estate sued his estate, as well as a drug manufacturer other than company X, along with fictitiously named defendants.  As to the drug company whose antidepressant was not taken by the shooter, her estate alleged a wide range of essentially product liability allegations related to the purported ability for the antidepressant, referenced by its branded name, to produce violent behavior.  Skipping and summarizing some procedural steps, the defendant manufacturer teed up the application of the Alabama statute based on the stipulation that the shooter had not taken a drug made by the defendant.  Summary judgment for the manufacturer was denied, but the trial court certified the following question for permissive appeal:

The controlling question is whether Alabama Code 1975, § 6-5-530, abrogated the Weeks decision and whether under current Alabama law a pharmaceutical manufacturer can have liability for a product it did not manufacture.

Plaintiff also contended that the statute was unconstitutional if it did abrogate the claims she asserted, but that was not presented on appeal.

On the issue presented, the decision was fairly straightforward, pretty much starting and ending with “the plain meaning of the words as written by the legislature.”  The only real addition was the clear timing of the legislation.  “[T]he enactment of § 6-5-530, coming on the heels of this Court’s decision in Weeks, clearly demonstrates the legislature’s intent in enacting that statute.” Moreover,

[I]t appears that, in enacting § 6-5-530, the legislature also incorporated provisions that rejected some of the reasoning this Court relied upon in reaching its decision in Weeks. Based on the foregoing, it is clear that, in enacting § 6-5-530, the legislature intended to abrogate this Court’s decision in Weeks. Further, under the plain language of § 6-5-530, a pharmaceutical manufacturer cannot be held liable for injury caused by a product it did not manufacture.

So, the very court that decided Weeks accepted that the legislature overruled it on purpose. That is how the rule of law and separation of powers are supposed to work. Those principles will also allow a further challenge that the Alabama statute was unconstitutional, although it is abundantly clear that legislatures can limit or even abolish certain court-made theories of liability.

 

We appreciate the emails in support of the position we took in our October 14 post on Apportionment Misadventures that we have received from ALI members.  We have just reviewed “Council Draft No. 6,” (we can’t link to it as per ALI guidelines) and are pleased to report that the section we criticized has been removed from the draft being submitted to the ALI Council in January.  We hope this means that a more even-handed draft will be forthcoming in the future, with provisions that more closely adhere to what the law actually has been.  For now, though, it doesn’t look like we need to be ready to go to the mat at next year’s annual meeting.

The Holiday season is also the cinema season. We’re giddy about movies right now. Today sees the release of the trailer for No Time to Die, the 25th Bond film (counting only the “official” EON productions – sorry about that, Casino Royale (1967) and Never Say Never Again (1983)). No Time to Die (hereinafter NTTD) will be Daniel Craig’s last performance as 007. While we won’t quite say that nobody does Bond better (Sean Connery was the first we saw in the role, and will always be first in our heart), Craig has been a brooding, menacing agent on Her Majesty’s Secret Service. To tide us over until NTTD premieres in April, we have Craig’s current fun, showy performance as a drawling detective in Knives Out, which is Rian Johnson’s take on Agatha Christie-esque murder mysteries. Rian Johnson is probably most famous for directing The Last Jedi, which was … fine. We’re hoping that the ninth episode in the Skywalker saga, The Rise of Skywalker, due out in a couple of weeks, will be more than fine. (One further tie-together: Daniel Craig had a brief moment in The Force Awakens as a stormtrooper reluctantly complying with Rey’s mind commands.)

Star Wars popped into our heads (it doesn’t take much) while reading a recent court opinion regarding child custody issues. That case also made us think about Sir Kenneth Clark’s great Civilisation series from 1969.

Let us explain.

The case is Matheson v. Schmitt, 2019 WL 6245773 (Mich. Ct. App. November 21, 2019). A divorced couple was squabbling over several child custody issues, but the only one of real interest to us is whether the child would be vaccinated. The mother, who had primary custody, said no, while the father said yes. The mother had religious objections to vaccination. Michigan law permits parents with religious objections to opt out of vaccinations, but here it was only the mother who harbored such objections. The father did not share those religious objections, and argued that his child should be vaccinated. Because of this dispute, the issue was tossed to the court, which needed to consider the best interests of the child. Satisfying the religious objections of one parent did not further those best interests (more on that later), so the mother grabbed hold of a fig-leaf of bogus medical objections. She contended that vaccination of the child was not in the child’s best interests “because vaccinations were medically contraindicated.” In support of this theory, the mother relied on testimony from the child’s pediatrician who stated that “a child’s potential predisposition to an adverse reaction from a vaccine can be gleaned from reviewing the child’s family medical history.” The plaintiff asserted that the child’s family’s medical history includes ailments “such as lupus, rheumatoid arthritis, psoriasis, and other autoimmune disorders, and therefore, the child would be predisposed to developing rheumatoid arthritis from her vaccinations.” But when the trial court asked the pediatrician whether a medical test exists that would predict a child’s predisposition to injuries arising from vaccines, the doctor responded that such a test does not exist.

The plaintiff presented evidence that vaccines can have adverse effects. That should arrive as news to precisely nobody. The Centers for Disease Control and Prevention (CDC) also acknowledges that vaccines carry a “remote chance” of causing serious injury or death. Additionally, the product insert for the MMR vaccine indicates that the vaccine may have an adverse reaction of causing thrombocytopenia, and a variety of other serious ailments, such as encephalitis and encephalopathy. In short, it was undisputed that vaccines can potentially cause very serious adverse effects. It was also undisputed that there was a family history of autoimmune disorders. Then the mother’s expert took things to crazy-plaintiff-town by testifying about undue influence exerted by pharmaceutical companies over the CDC.

The Matheson appellate court preferred the land of lucidity. In affirming the trial court’s order in favor of vaccination, the appellate court held that “the dispositive issues are not whether vaccines can potentially cause adverse effects, or whether the vaccine manufacturing industry and pharmaceutical companies are unduly influencing governmental regulatory agencies. Instead, what is at issue is whether the administration of vaccinations is in the child’s best interests, taking into account her physical health. Even accepting as valid and accurate plaintiff’s contention that the child bears some predisposition to incurring an autoimmune disorder because of her family history, this attenuated risk, in and of itself, simply does not outweigh the significant benefits that would inure to the child by protecting her from the threat of serious and life-endangering diseases in the population. Put another way, the threat of harm to the child by exposing her to vaccines that could potentially trigger an autoimmune disorder is speculative, and the record does not otherwise demonstrate that the child would be put at risk of harm by receiving vaccinations.”

Both the treating pediatrician and the father’s expert medical witness testified that they recommend that children receive the vaccinations suggested by the CDC and the state of Michigan. Conversely, the mother’s expert witness had not personally evaluated the child and, while familiar with the child’s “medical records and her family history, testified generally about potential adverse reactions to vaccines and notably did not provide any substantive evidence, aside from possibilities and speculation that the child would be harmed by the administration of vaccines.” That thin presentation against vaccines could not overcome evidence that whooping cough is at “epidemic proportions” in Michigan and that it can lead to pneumonia, and even death for a child. The plaintiff did not present persuasive evidence establishing that “[the child] will be harmed by any particular vaccination and/or that any particular vaccination is otherwise contrary to [the child’s] best interests.” On the grounds of science, the mother’s cases against vaccination was a loser.

What really drove the case was the mother’s strong religious objections to the use of vaccines because “some vaccines are cultured in aborted fetal cells” and also contain animal blood. The trial court duly considered plaintiff’s objections to vaccines when considering “[t]he capacity and disposition of the parties … to continue the education and raising of the child in his or her religion or creed, if any.” The trial court ultimately did not find that the plaintiff’s testimony on the subject of her religious objections rendered this factor “more or less favorable to either party.” Accordingly, the appellate court held that “the trial court did not err by determining that it was within the child’s best interests to be vaccinated.”
The appellate court in Matheson also held that the trial court did not abuse its discretion in rejecting the mother’s proffer of expert testimony by a doctor “in the areas of adversomics, which addresses the adverse effects of vaccine injuries.” The expert had an “extensive educational and professional background in pediatric medicine, and her interest and work with vaccine-related topics,” but there was no showing that the expert had “been educated in , or worked professionally in, the specific and specialized area of adversomics for which plaintiff sought to qualify her as an expert.” Moreover, the court was “unable to discern exactly what comprises the specialty of adversomics,” and what “specialized knowledge” the expert could offer the trier of face in these proceedings.
Indeed.

****

If you haven’t seen the Civilisation series (the “s” is the British spelling), do yourself a favor and watch it. It is as relevant today as it was 50 years ago. The first episode is called “The Skin of Our Teeth.” It is about the Dark Ages (the six centuries following the fall of the Roman Empire) when Europe survived and ultimately emerged from violent paganism only because some monks huddled off the Irish coast and preserved art and scholasticism. By the end of the series, Clark blasts the then current era’s lack of confidence and seems to see the barbarians at the gate. That was back in 1969. By now, the barbarians seem to have made their way in and grabbed hold of the levers of power. Or perhaps as the cartoon character Pogo once famously said, “we have met the enemy and they is us.” Granted, we are growing ever grumpier and more pessimistic as we stumble toward dotage. Maybe we are the grouch yelling at millennials to get off our lawn. But to our moldy eyes, the glories of the Enlightenment are on the verge of being squandered. Voltaire and Franklin would be hooted by a talk-show audience or campaign rally crowd. Goodbye scientific method, hello idiocracy. Anti-vaxxers and climate-change deniers worry us. We seem to be sliding into a new Dark Age. The Matheson case is a brief moment where someone of sense leapt atop the pile of foolishness and called for a halt. (You should certainly take a look at Kenneth Clark’s description of Rodin’s Balzac sculpture – possibly the finest sculpture since Michelangelo — as a figure who says no to “lies, tanks, teargas, ideologies, opinion polls… the whole lot.”) With the current ascendancy of anti-fact know-nothingism, perhaps a small group of people who care more about truth than preference will hunker down on a small island (Martha’s Vineyard would be nice), and wait out the orgy of ignorance. In Civilisation, one of the places where the monks tended to their precious illuminated books while eluding chaos was Skellig Michael, a fearsomely remote and rocky crag west of Ireland. This tiny, forbidding island probably seemed hardly worth the bother to the Vikings. Skellig Michael also served as the location for Luke Skywalker’s retreat in The Last Jedi. So, yes, as always, everything comes back to Star Wars.

We’d like the answer to that question to be – most of the time.  But that’s too much to hope for.  After all, lawsuits are brought in California.  With its plaintiff-friendly laws, indeed, California is an often sought after venue by mass tort products liability plaintiffs.  But, according to a recent California appellate court decision, if the plaintiff isn’t from California or the injury didn’t occur in California, it is unlikely California law applies.

Chen v. Los Angeles Truck Centers, LLC, — Cal. Rptr. 3d –, 2019 WL 6242110 (Cal. App. Nov. 22, 2019) is not a prescription drug or medical device case.  It is a products liability action.  Plaintiffs were foreign tourists who were injured in bus accident in Arizona.  They settled their claims with the bus tour company and bus driver.  The pending lawsuit was brought against the Indiana manufacturer of the bus and the California distributor who purchased it and sold it to the tour operator.  Id. at *1.  So, in our DDL world this is analogous to non-California plaintiffs suing a non-California drug/device manufacturer and a California distributor.  Not a wild hypothetical.

Defendants asked the court to apply Indiana law, which it did.  Before trial, the Indiana manufacturer settled with plaintiffs.  Then a defense verdict was entered in favor of the distributor and plaintiffs appealed the choice of law determination.  The appellate court upheld the application of Indiana law.

California employs the governmental interest test in deciding choice of law questions.  The test has three-parts:  (1) are the laws of each state in fact different; (2) if so, what is each state’s interest in application of its own law under the circumstances of the particular case to determine if there is a true conflict; and (3) if so, which state’s interest would be more impaired if subordinated to the policy of the other state.  Id. at *3.

Question 1 – Indiana and California product liability laws are different.  Not surprisingly, Indiana law is more favorable for defendants.  It “imports a negligence standard into the definition of a defective product.”  Id. California law does not.

Question 2 – Only Indiana has a true interest in application of its law in this circumstance.  Indiana has a more “business-friendly” product liability rule which “furthers Indiana’s interest in providing an attractive environment for its manufacturers by protecting them from excessive liability or damage awards.”  Id. at *4.  The court compared that with the policy underlying California’s more plaintiff-friendly law and put it into context given the particular case circumstances:

[T]he underlying basis for the policy is the protection of California residents and other persons within its territorial jurisdiction from injury. California’s interest in imposing that policy becomes hypothetical when the injured persons are not California residents and were not injured in California.

Id. at *5.

Put another way, the policy behind California’s strict liability rule “is to ensure that the costs of injuries resulting from defective products are borne by the manufacturers . . .  rather than by the injured persons.”  Id.  However, the only California party in this case was the distributor.  So, California’s interest in protecting its citizens or passing the costs to manufacturers is at best hypothetical when the case does not involve California plaintiffs or a California manufacturer.

Question 3 – The court didn’t need to reach it having answered the second question in the negative, but it examined the issue anyway.  For basically all of the same reasons it concluded California’s interest was only hypothetical, it also concluded that Indiana’s law should not be subordinated to California’s.  Id. at *7-8.  Applying California law in this case “would not protect California residents or anyone who was injured in California.”  Id. at *8.  Nor would it “protect California residents and persons who are injured in California from having to bear the financial costs of injuries caused by defective products.”  Id.

In a drug/device case, this should mean California law does not apply to cases involving non-California plaintiffs and a non-California manufacturer.  In that situation, the court would have to use the governmental interest test to choose between the home state of the manufacturer and the home state of the plaintiff (usually also where the injury occurred).  Typically, the home state of the plaintiff wins out in those situations, with some limited exceptions (i.e. which law applies to punitive damages claims).  But what does this case mean for a suit brought in California by non-California residents against a California manufacturer.  If the primary policy behind California’s product liability laws are protection of California residents, the holding of this case should still apply.  It is a fairly sweeping holding.  Without a California plaintiff or a California-based injury, California law doesn’t apply.  And while we often say choice of law decisions are difficult to categorize as pro-defense or pro-plaintiff because they can be used to either sides’ benefit – we’re pretty sure we can say a decision limiting application of California law is a defense win.

We’ve used the phrase “one-two punch” before in the blog to describe a pair of legal decisions concerning the same product.  Usually, our clients have been on the winning side, but that’s not always true, particularly in cases coming out of Philadelphia, Pennsylvania.  In November, the Pennsylvania appellate courts, in gynecomastia litigation, dealt defendants two significant setbacks.

The first decision was from the Pennsylvania Supreme Court and dealt with an issue we don’t cover that much – due to state- and fact-specificity – the statute of limitations.  But what went down in In re Risperdal Litigation, ___ A.3d ___, 2019 WL 6139189 (Pa. Nov. 20, 2019) (“IRRL”), involves the realities of mass torts as much as any particular facts, so it’s worth discussing.  The legal press has indicated that the impact of IRRL will be the resurrection of “thousands” of gynecomastia plaintiffs’ cases, and that’s why the case is significant.

First off, Philadelphia seems to be just about the only place where this type of gynecomastia litigation has achieved any traction.  As other courts have pointed out, the FDA did not even consider this condition to be a “serious” hazard.

[A] November 2014 letter from a FDA senior official [stated] that “Gynecomastia is a common clinical manifestation of hyperprolactinemia, regardless or cause, and does not represent a serious adverse event as defined in 21 C.F.R. §312.32(a). . . .  [T]he parties’ regulatory experts both agreed (one readily and the other begrudgingly) that, according to the FDA’s own regulations, gynecomastia would not be a serious adverse event.

*          *          *          *

[I]t is undisputed that gynecomastia was not a “serious” hazard pursuant to the regulations in existence during the time in question. . . .

Byrd v. Janssen Pharmaceuticals, Inc., 333 F. Supp.3d 111, 122, 124 (N.D.N.Y. 2018).  Byrd quoted the FDA’s 2014 rejection of a citizen petition – brought by a Philadelphia plaintiff-side lawyer  That lawyer sued the FDA over the denial and lost.  Sheller, P.C. v. United States Dept. of Health & Human Services, 663 F. Appx. 150, 155 (3d Cir. 2016) (“gynecomastia is not a serious adverse event”; affirming dismissal).  See Moots v. Secretary, Dept. of Corrections, 425 F. Appx. 857, 858 (11th Cir. 2011) (“gynecomastia requires only cosmetic treatment”; it is not [a condition] that, if left unattended, poses a substantial risk of serious harm”) (citation and quotation marks omitted); D.E. v. Dept. of Public Welfare, 2008 WL 9399228, at *3 (Pa. Commw. Oct. 10, 2008) (“in most cases, gynecomastia spontaneously regresses within three years after its onset”); Schilling v. Ellis Hospital, 906 N.Y.S.2d 187, 189 (N.Y.A.D. 2010) (“a reasonably prudent patient in those circumstances would agree to take that medication despite being informed of the low risk of gynecomastia, which is a treatable, non-life-threatening condition”); Cleveland v. Janssen Pharmaceuticals, 2019 WL 6114719, at *4 (E.D. Cal. Nov. 18, 2019) (“[t]he FDA has characterized gynecomastia as a nonserious risk”); Garcia v. McLean, 2018 WL 1788072, at *11 (Mag. N.D.W. Va. Feb. 22, 2018) (“gynecomastia does not meet the standard to be recognized as a serious medical condition”), adopted, 2018 WL 1785481 (N.D.W. Va. April 13, 2018); Rankins v. Washington, 2017 WL 4364060, at *3 (W.D. Mich. Sept. 29, 2017) (“the absence of physical complications from gynecomastia is not uncommon”); Fryman v. Traquina, 2009 WL 5199257, at *6 (Mag. E.D. Cal. Dec. 23, 2009) (“gynecomastia is a benign condition that does not cause pain”; “it is not physically harmful”), adopted, 2010 WL 624389 (E.D. Cal. Feb. 19, 2010); see also Internet research in Ayoubi v. Altez, 2017 WL 773883, at *4 (N.D. Ill. Feb. 27, 2017), vacated, 729 F. Appx. 455 (7th Cir. 2018) (holding that judges are not supposed to do their own Internet research).

Because plaintiffs making these claims seem to do much better in Philadelphia than anywhere else, thousands of them – recruited almost entirely by lawyer advertising – have flocked to that jurisdiction.  Unfortunately, they can do that, because the manufacturer is a Pennsylvania corporation, making general personal available under Daimler AG v. Bauman, 571 U.S. 117 (2014).  So the jurisprudential issue is presented how to deal with all of these cases.

Mass torts present a “mass” problem with respect to the statute of limitations.  As we discussed, New Jersey law has responded to this problem with a special choice of law rule for mass tort litigation plaintiffs – New Jersey law will always apply.  In re Accutane Litigation, 194 A.3d 503, 506 (N.J. 2018).  If plaintiffs don’t like it, they can “bring suit in the state where they reside . . . and probably enjoy the benefit – if it is a benefit – of their own state law.”  Id.  Pennsylvania has not gone that route, so the trial court (later affirmed by the intermediate appellate court) chose another way to achieve a global resolution.  The court recognized a global accrual date for all gynecomastia claims, “ruling . . . that any claim filed after June 31, 2009, must be dismissed on statute of limitations grounds based upon the cumulative effect of medical literature, newspaper articles and attorney advertising present by that point in time.”  IRRL, 2019 WL 6139189, at *3.  This had been done before in other mass torts.  IRRL mentioned three of them, involving the drugs Vioxx, Seroquel and Avandia.  Id. at *14.  We would add the Orthopedic Bone Screw litigation, where “a universal date of discovery” that turned out to be “outside the applicable [one-year] statute of limitations” resulted in dismissal some 1500 plaintiffs’ suits.  Maestas v. Sofamor Danek Group, Inc., 33 S.W.3d 805, 809 (Tenn. 2000).

In IRRL, the global accrual date adopted by the lower courts closely corresponded to the advent of plaintiff-side attorney advertising.

The . . . lawyer advertisement . . . [w]ithout question it links the ingestion of [the drug] with the incidence of gynecomastia.  As it was uploaded on June 25, 2009 and the trial court set June 30, 2009 as the final accrual date for all [drug]-related gynecomastia claims, this video was apparently the straw that broke the camel’s back for the trial court, such that any potential plaintiff’s “inquiry should have been awakened.”

2019 WL 6139189, at *14 (citation omitted).

In IRRL, however, the Supreme Court disagreed with the courts below and held that the evidence for the asserted global accrual date was insufficient to toll Pennsylvania’s discovery rule in every case:

Unlike in these cases, we cannot conclude, as a matter of law, that the present case involves the degree of publicity required to place [plaintiffs] on notice of the relationship between their injury and its cause. . . .

It may fairly be questioned as to whether the national attention regarding the link between [the drug] and gynecomastia compares favorably with the extent of media coverage in the [Avandia, Vioxx and Seroquel] cases.  In the present cases, the trial court referenced three medical journal articles (all published in 2003-2004), nine newspaper articles (spread over eight years), two television news programs in 2008, and a YouTube video.  However, the FDA did not require a black box warning on the [drug’s] label, no national health organizations issued warnings to physicians and patients, no statistics regarding decreases in prescriptions have been cited in support of the extent of the media coverage into local markets, there was no national media “blitz,” and [defendants] did not issue any “Dear Doctor” letters advising prescribing physicians of the 2006 label change.

IRRL, 2019 WL 6139189, at *14-15.

The Pennsylvania Supreme Court did not state that this information was insufficient as a matter of law to satisfy the discovery rule, only that individualized adjudications would be required:

This is not to say that the publicity (including the medical journal articles) cited by the trial court in this case was insufficient to place [plaintiffs] on notice (at any particular point in time) that their ingestion of [the drug] was the cause of their gynecomastia. . . .  Rather, we conclude only that reasonable minds could differ, thus requiring that the factual issues relating to [defendants’] statute of limitations defense must be submitted to a jury for resolution.

Finally, the scope of the distribution and information linking [the drug] to gynecomastia in the medical journal articles, media reports and lawyer advertising does not cumulatively, as a matter of law, lead to the conclusion that [plaintiffs] were put on inquiry notice sufficient to establish a June 30, 2009 accrual date for their causes of action.

Id. at *15.

So, what now?  If that quantum of evidence isn’t enough globally, is it enough for particular plaintiffs?  It may well be.  “We do not suggest that [defendants’] contention that [plaintiffs] were aware of their injuries in 2002 and 1998 is incorrect.  Rather, we conclude only that given that the evidentiary record here is entirely undeveloped.”  Id. at *9.  The alternative the court seems to envision is individual discovery in all of the returning cases.  Since IRRL itself involved only two plaintiffs, and they were both Pennsylvania residents, id. at *2-3, the Pennsylvania Supreme Court didn’t have any mass tort considerations directly before it.

That obviously means a lot more work for lawyers.  The idea of a “universal” or “global” discovery date (like New Jersey’s choice of law decision) was an attempt to ameliorate this.  At minimum, this discovery will involve review of all plaintiffs’ medical records for knowledge of risks that plaintiffs would have had access too, depositions of the plaintiffs’ parents/guardians (both plaintiffs in IRRL were minors), and treaters (for what they informed the parents/guardians and when).

Also, as the Supreme Court’s repeated references indicate, attorney advertising will be a key issue.  Both of the plaintiffs’ suits in IRRL were prompted by attorney advertising.  2019 WL 6139189, at *3.  If our prior experience with tobacco litigation is any indication, the use of advertising historians to establish on exactly what media programs/internet websites drug-related advertisements ran, combined with discovery of plaintiffs’ parents/guardians viewing history of mass and Internet media, will have to be involved.  Since only the plaintiffs’ side knows precisely where they ran their advertisements, this could make for some interesting discovery.

What can’t be allowed to happen is, with IRRL precluding one attempt at managing the volume of discovery of a mass tort, the plaintiffs proposing their own shortcuts that deny defendants the right to take the individualized discovery, and to make the individualized record, that the Supreme Court envisioned.  This has happened before in Philadelphia.  Cf. Rost v. Ford Motor Co., 151 A.3d 1032, 1054 (Pa. 2016) (declaring Philadelphia practices that formerly required consolidated trials in mass tort cases to be “error”).

We also note that one way that some of the “mass” could be removed from this litigation would be by more rigorous enforcement of the standards for interstate forum non conveniens.  While the particular plaintiffs in IRRL were Pennsylvanians, we expect that most of the returnees will be litigation tourists.  Since they can’t be forced back to their states of residence by personal jurisdiction, the only alternative is discretionary forum non conveniens motions.  In a recent case involving another defendant unfortunately incorporated in Pennsylvania and a litigation tourist plaintiff, the court pointed out that, when interstate (as opposed to intrastate) forum non conveniens is raised, “[a] plaintiff’s choice of forum is entitled to deference, but to a somewhat lesser degree when the plaintiff’s residence and place of injury are located somewhere else.”  McConnell v. B. Braun Medical Inc., ___ A.3d ___, 2019 WL 5203925, at *3 (Pa. Super. Oct. 16, 2019).  The defendant lost in in McConnell, but that (like IRRL in a different context) was due to an insufficient record.  Properly supported forum non conveniens motions (if possible on sets of facts we don’t know) could find a receptive judicial audience, should “thousands” of returning cases involve litigation tourist plaintiffs having no good reasons, beyond dollar signs, for burdening Philadelphia courts and taxpayers.  Forum non conveniens motions, backed by facts providing the judges running the Philadelphia Complex Litigation Center what McConnell says they need, might accomplish what personal jurisdiction can’t in that litigation.

That’s one.

The second seriously adverse Pennsylvania decision in the same litigation occurred six days later in A.Y. v. Janssen Pharmaceuticals Inc., ___ A.3d ___, 2019 WL 6317403 (Pa. Super. Nov. 26, 2019).  While IRRL was the end of the appellate line, A.Y. can, and deserves to be, appealed further.  A compensatory-damages-only “judgment of $70 million,” id. at *1, in a case involving an injury that elsewhere in the country – including by the FDA − isn’t even considered “serious”?  Somebody needs to get real.  So, the sheer excessiveness of this verdict cries out for a new trial.  That verdict is apparently “30 times larger than the next largest compensatory verdict in Philadelphia.”  Id. at *22.

Indeed, A.Y. may well be the largest product liability verdict in Pennsylvania history to survive appeal.  A $55,000,000 crashworthiness verdict was affirmed in American Honda Motor Co. v. Martinez, 2017 WL 1400968, at *1 (Pa. Super. April 19, 2017) (unpublished), but that plaintiff was a quadriplegic, and non-economic damages were “only” $25 million.  Id.  Cf. Tuski v. Ivyland Café, 2004 WL 4962363, at *24 (C.P. Philadelphia Co. Dec. 22, 2004) ($50 million compensatory award to quadriplegic plaintiff held excessive); Harker v. Chan, 2018 WL 3599734, at *15 (W.D. Pa. July 27, 2018) ($43,750,000 compensatory award to permanently disfigured plaintiff held excessive).  The only Pennsylvania verdict we know of that is larger was $78 million for obstetrical malpractice leading to quadriplegic cerebral palsy from birth.  See Nicholson-Upsey v. Touey, 2012 WL 3067501 (Pa. C.P. Philadelphia Co. May 4, 2012).

As already discussed, gynecomastia is not even a serious injury.  Several of the cases we cited above discussed surgery as providing a permanent fix.  E.g., Rankins, 2017 WL 4364060, at *3 (“Surgical removal of excess breast tissue is effective but rarely necessary.”).  See also Schulman v. Group Health Inc., 833 N.Y.S.2d 62, 64 (N.Y.A.D. 2007) (ordering insurer to pay for gynecomastia surgery).  “Compensatory damages are to compensate for the full extent of the injury sustained, and the award should be limited to compensation alone.”  Moorhead v. Crozer-Chester Medical Center, 765 A.2d 786, 790 (Pa. 2001).  Plainly A.Y. verdict carries a punitive element, and should be reversed for that reason alone.  A new trial wouldn’t even be a significant expenditure of additional resources, since the cross-appeal already requires a second, punitive damages trial.  A.Y., 2019 WL 6317403, at *23.

A.Y. is something of a muddle and it’s not clear whether the court was applying Pennsylvania or Tennessee law.  We don’t know anything about Tennessee, but we have dealt with excessiveness issues in Pennsylvania.  In the surviving portion of Foley v. Clark Equipment Co., 523 A.2d 379 (Pa. Super. 1987) (a product liability ruling in Foley having nothing to do with excessiveness was later overturned), the Superior Court offered a formula against which excessiveness claims should be judged:

Were [we not reversing on other grounds], we would find that the $15,000,000 verdict was excessive.  If invested at the legal rate, the amount of the verdict would produce an annual income of $900,000.  This exceeded by far the plaintiff’s earning capacity, and although appellant sustained serious and incapacitating injuries, the record does not support this grossly excessive verdict.

Id. at 394-95.  The “legal rate” in Pennsylvania is 6% simple interest.  42 Pa. C.S. §8101; 41 P.S. §202.  Just the interest at the “legal rate” on A.Y.’s $70 million non-economic damages verdict is $4.2 million per year.  As in Foley, just the annual interest on the noneconomic damages dwarfs any conceivable earning capacity that plaintiff A.Y. could have.  Prior panel decisions of the Superior Court are “binding precedent,” A.Y., 2019 WL 6317403, at *23, but A.Y. doesn’t even cite Foley.  The Foley formula demonstrates how grossly excessive the verdict in A.Y. truly is.  One year’s interest on that verdict, alone, would earn that physically unimpaired plaintiff much more money than most people earn in a lifetime.  Its punitive nature shines like a beacon.

More recently, in another purely non-economic case, a “$26,600,000 jury award of damages . . . was excessive − if not punitive − and clearly beyond what the evidence warrants.”  Polett v. Public Communications, Inc., 2016 WL 3154155, at *3 (Pa. Super. June 6, 2016) (en banc) (citation and quotation marks omitted).  All of the four judges in Polett who agreed the verdict was excessive still sit on the Superior Court; only the lone dissenter has taken senior status.  Conversely, none of the Polett judges also sat on A.Y.  Since, a finding of excessiveness is appropriate “[w]here the jury’s verdict is so contrary to the evidence as to shock one’s sense of justice,” Kiser v. Schulte, 648 A.2d 1, 4 (Pa. 1994), finding some new judges with consciences that may be “shocked” by this verdict would be very good idea.

Another questionable aspect of A.Y. is its preemption ruling.  Once again, the opinion is less than pellucid, this part being mostly a succession of block quotes from this and that prior opinion, making it difficult to follow either the defendants’ arguments or the court’s rationale.  Apparently the defendants argued impossibility preemption – that “it was impossible for [defendants] simultaneously to comply with its federal and state-law obligations regarding [drug] labeling of pediatric gynecomastia risks.”  2019 WL 6317403, at *6 (internal quotation marks omitted).  There are a lot of subsidiary problems with A.Y., such as continued reliance on a “presumption” against preemption, id. at *6, after Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), demoted it back to a mere “assumption”; and substantial reliance on Hassett v. Dafoe, 74 A.3d 202, 210 (Pa. Super. 2013), an extreme outlier generic preemption decision that hasn’t been followed by a single court anywhere else in over five years.  But we’ll ignore those and try to cut straight to the chase, as we see it.

The defendants’ preemption argument to us seems like a sound one, particularly since Albrecht declared preemption to be a matter of law, rendering the court’s critical reliance on plaintiffs’ expert witness, A.Y., 2019 WL 6317403, at *8, unnecessary.  The defendants’ position is characterized as an “off-label use defense,” id., which means that the argument is undoubtedly similar to the post we wrote here, pointing out the following two FDA provisions:

A specific warning relating to a use not provided for under the “Indications and Usage” section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.

21 C.F.R. §201.57(c)(6)(i) (emphasis added).

A specific warning relating to a use not provided for under the “Indications and Usage” section of the labeling may be required by the Food and Drug Administration if the drug is commonly prescribed for a disease or condition, and there is lack of substantial evidence of effectiveness for that disease or condition, and such usage is associated with serious risk or hazard.

21 C.F.R. §201.80(e) (emphasis added).  The references in §201.57 to sections 201(n) (21 U.S.C. §321(n)) and 502(a) (21 U.S.C. §352(a)) of the FDCA are to general provisions relating to misbranding.

Since only the FDA can “require” warnings about off-label uses, that places the warning claims in question outside of the FDA’s CBE regulation (which does not expressly extend to off-label uses in any event), and puts them squarely within the “independence principle” enunciated by PLIVA, Inc. v. Mensing:  “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”  564 U.S. 604, 623-24, (2011).  Oddly, A.Y. nowhere cites to either this principle or, indeed, to Mensing itself (also absent is Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), which reinforced Mensing).  This complete failure to come to grips with contrary, controlling precedent casts serious doubt on A.Y.’s rationale.

What A.Y. does hold – albeit briefly and without analysis – is that the FDA’s regulatory scheme back in 2003 (when the minor plaintiff was first prescribed the drug) was different than it is now:

Plaintiffs[] assail [defendants’] “off-label use” defense as also being inconsistent with governing statutory law as it existed at the time. . . .  Specifically, [plaintiffs] accurately point out that 21 C.F.R. §201.57(f)(9)(i), which pertained to “pediatric care,” was in effect in 2003 and provided that any “specific hazard” associated with an unapproved pediatric use “shall be described in this subsection of the labeling. …” Id.

2019 WL 6317403, at *8.  This is the key point.  If drug companies were free to add warnings (or other information) about off-label uses at their leisure, then A.Y. would be right :  (1) the “independence principle” would be satisfied, (2) defendants would be within the scope of the FDA’s CBE regulation; and (3) the only preemption argument available would be “clear evidence” under Albrecht and Wyeth v. Levine, 555 U.S. 555 (2009), which is a “demanding defense.”  2019 WL 6317403, at *6.

We had to learn how to access the “historical” C.F.R. in Westlaw order to evaluate this argument, since A.Y. is not, in fact, “accurate.”  A.Y. both misnamed the relevant regulation (which involves “pediatric use,” not “pediatric care”), and miscited only snippets from the wrong subsections.  In 2003, §201.57(f)(9)(i), did not contain the word “hazard.”  Instead, the actually relevant section provided:

(vi) If the requirements for a finding of substantial evidence to support a pediatric indication or a pediatric use statement have not been met for any pediatric population, this subsection of the labeling shall contain the following statement: “Safety and effectiveness in pediatric patients have not been established.”  If use of the drug in premature or neonatal infants, or other pediatric subgroups, is associated with a specific hazard, the hazard shall be described in this subsection of the labeling, or, if appropriate, the hazard shall be stated in the “Contraindications” or “Warnings” section of the labeling and this subsection shall refer to it.

201.57(f)(9)(vi) (2003) (containing the word “hazard”).  This drug was approved for a number of pediatric indications in 2006.  A.Y., 2019 WL 6317403, at *2 (approval for “irritability associated with autistic disorder in children and adolescents (between the ages of 5 and 16), including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums and quickly changing mood”).  The opinion does not directly state whether the 2006 pediatric indications included the minor-plaintiff’s treatment, but we think so, given that the conduct being treated sounds similar.  Id. at *3 (“Attention Deficit Hyperactivity Disorder” and “Oppositional Defiant Disorder”); at *15 (“biting, hitting, smashing windows out with his fist, persistent fighting with other children, refusal to follow instructions at school or at home, and on one occasion breaking a chicken’s back”).  If the treatment were still off-label in 2006, it would then be governed by a different section (assuming no regulatory changes through 2006), §201.57(f)(9)(v) (2003) (governing off-label use “for a particular pediatric population”).  However, the relevant “hazard” language was identical in both subsections.

So the question becomes, is gynecomastia a “specific hazard” that would fall within either §§201.57(f)(9)(v-vi) back in 2003?  A.Y. skips right over this critical point, its parade of block quotes nowhere addressing it.  Why?  Because of what we discussed above.  The FDA has never considered gynecomastia a “serious” hazard warranting a warning.  That’s what the cases we cited at the outset are about, and that’s why a Philadelphia plaintiff-side lawyer took the extraordinary step of not only filing a citizen petition to try to change this – but also trying to sue the FDA when it denied its position.  Back in 2003, the same overall regulation limited the scope of warnings to “serious” hazards or risks:

Warnings. Under this section heading, the labeling shall describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur.  The labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.

21 C.F.R. §201.57(e) (2003) (emphasis added).  The same is true of off-label use – “a use not provided for under the ‘Indications and Usage’ section of the labeling”:

A specific warning relating to a use not provided for under the “Indications and Usage” section of the labeling may be required by the Food and Drug Administration if the drug is commonly prescribed for a disease or condition, and there is lack of substantial evidence of effectiveness for that disease or condition, and such usage is associated with serious risk or hazard.

Id. (emphasis added).  Note the “required by the [FDA]” language.  Back in 2003 – as now – the FDA reserved to itself whether to require warnings about off-label uses.  The Mensing independence principle applies, and thus the claim is preempted without regard to Levine and “clear evidence.”

Thus, the defendants were correct, and the A.Y. decision was not, about whether the defendants had the ability to make a label change concerning an off-label use in 2003 without FDA prior approval.  That being the case, most of the A.Y. discussion, including the block quotes from Albrecht, are simply inapposite.  Plaintiffs could never put the defendants inside the terms of the CBE regulation in the first place.  Therefore the “clear evidence” standard, whatever it might mean after Albrecht, doesn’t apply.  Rather, the Mensing independence principle should govern A.Y. because applicable FDA regulations in 2003 mandated that an off-label warning can only be “required by” the FDA and thus the manufacturer could not act independently.  After Albrecht, moreover, all this is a question of law, not of fact for either juries to decide or for either sides’ experts to offer opinions.

So we have two aspects in which we think A.Y. was quite erroneous – liability and damages.  If we wanted to prolong this post, we could also take issue with:  (1) repeated reliance on preempted claims of fraud on the FDA (id. at *12) (Kessler fraud on the FDA testimony); *20 (“[i]nstead of submitting this information to the FDA . . . Defendants withheld and concealed the results”); (2) misreading of the Tennessee damages cap statute (id. at *20-21) (equating a state statutory spoliation exception with production of materials to the FDA governed solely by federal law), or (3) the exclusion of evidence of conduct by the minor plaintiff indicative of possible bullying behavior, while simultaneously seeking millions in damages for being “bullied.”  Compare Id. at *15 (minor plaintiff described as engaging in biting, hitting, fighting, vandalism, insubordination, and animal cruelty), with id. at 23-24 (claims of being bullied).  However, these issues are either evidentiary, and thus arguably governed by an abuse of discretion standard, or involve a Pennsylvania court misinterpreting another state’s law.  As such they are less clear-cut or significant than the glaring errors we have discussed above.

That’s number two.  So while we have to admit that Pennsylvania plaintiffs landed two stinging appellate blows within a week of each other in different aspects of the same litigation, it’s still time for the next round.

Picture this. Invitations go out for a Thanksgiving get-together and the host and expected guests together sort out who will bring what foods and how everything will be served. A sideboard is loaded up with the traditional holiday foods, along with a collection of everyone’s quirky favorite salad items to allow easy compilation of a guest-specific salad. Most of the guests arrive on time and eat their fill. The host fulfills her function with efficient seating, intercession in minor squabbles, and ample beverages. Like Thor’s goats, the traditional holiday foods magically replenish no matter how many guests have sampled them. Sated guests have retired to watch more football. In short, the gathering was as a Thanksgiving should be. Then, a guest appears at the door, is invited in, and directed toward to the sideboard with instructions on how to help herself, how to find a seat, and how to find beverages. The late-to-the-party guest says this arrangement is insufficient. She wants a plate prepared just for her, including both the general and guest-specific foods she contends the host should know how to pick for her, and brought to her at her preferred seat, which is on the sofa rather than the dining room table where everyone else ate. Mind you, she could have prepared her own plate and sat at the table, but she insists that a host must give her special treatment because she would not have had to prepare her own plate had she dined solo at a sit-down restaurant (excluding buffets and smorgasbords). Undoubtedly, this guest is being a jive turkey, if not an insufferable pig.

We think the plaintiff’s position in Williams v. Biomet, Inc., No. 3:18cv00211RLM-MGG, 2019 U.S. Dist. LEXIS 199802 (N.D. Ind. Nov. 15, 2019), is much like that of the boorish guest above. Her suit was transferred to the M2a hip implant MDL about six years after it was established and more than two years after generic discovery closed. (We have chimed in on a few decisions from this MDL over the years. See here.) The MDL had in place a vendor for easy access to documents produced by the defendants and a system for case-specific discovery that built on a Defendant Fact Sheet and production of specified case-specific documents. Rather than go forward with the typical case-specific depositions of the plaintiff, a treating surgeon, and one of defendant’s sales representatives, the plaintiff moved to compel the defendant to answer her written discovery in the way she wanted. She did not want to obtain generic or case-specific information from the MDL plaintiffs’ leadership or the third-party vendor selected by the parties years before. No, she wanted everything on a silver platter.

As to this issue, the court was not sympathetic to plaintiffs’ high maintenance demands. It noted that this motion to compel was brought after “[h]undreds of cases already have been remanded or transferred to other courts for trial, with all parties and courts understanding that most case-specific, and all non-case-specific discovery (also described as ‘general’ and ‘generic’ in past orders), has been completed in the MDL court.” Id. at *7. The defendant had “produced millions of documents and custodian-deponents early in the docket’s life”; these were available through the plaintiffs’ leadership, as was the complaint file on each plaintiff. Id. Medical records gathered on each plaintiff were available through the agreed vendor “on the same terms the records are available to [defendant].” Id. at *8. In responding to plaintiffs’ written discovery, defendant directed plaintiff to those sources, as it presumably had in hundreds of other cases in the MDL. “Ms. Williams contends that isn’t good enough, that [defendant] must produce the requested information and documents to her counsel rather than simply point her to a bucket full of discovery.” Id. Of course, this is an MDL and an MDL is supposed to promote efficient and non-repetitive discovery. We have described many issues we take with the general pro-plaintiff, pro-settlement slant in many modern MDLs, like here, here, and here, but we certainly agree with this foregoing principle and its application here.

Defendant’s approach did not deprive plaintiff of access to general or case-specific discovery or place an undue burden on her.

Biomet produced hundreds of thousands of documents in electronic form to Record Trak for the Plaintiffs’ Steering Committee, which serves as a stand-in for each plaintiff for purposes of receipt of discovery materials. The files are readily searchable. Ms. Williams says she shouldn’t have to conduct that search (which carries a cost as well as a risk that her search would miss documents pertinent to her case) because the rules of procedure place that burden on Biomet. If she’s right, a defendant in a mass tort MDL would have to search through the same electronic files thousands of times to narrow the pile of files down to those relating to a given plaintiff. Or Ms. Williams must conduct the search, but only once. Ms. Williams’s argument would defeat one of the main efficiencies of the MDL process.

Id. at *9. So, she basically gets what everyone else gets. Coming in late and asking for special treatment “just because” are not good reasons for deviating from the existing, established procedure. Any defendant in an MDL or state coordinated proceeding can appreciate this dynamic, and, while it might be nice to say a picky plaintiff should get nothing and like it, keeping the sideboard open for the late-arriving guests is better than having to make up a bunch of ad hoc plates of discovery for them.

Enjoy your giving of thanks and partaking of gluttony.

When we discuss the learned intermediary rule, it is typically in the context of protecting our drug and device manufacturer clients. If a manufacturer warned the doctor, it discharged its duties, and a plaintiff should not be able to claim that he or she was not directly warned. We do not often represent pharmacies, but we’d usually just as soon see them escape liability as well, if only to keep them out of the case and keep them from wrecking federal diversity. Thus, we have often written about cases that shut down failure to warn claims against pharmacies – see here and here, for example.

Illinois was already on the correct side of the ledger, refusing to put pharmacies on the hook for failure to warn. That same legal position was applied, and perhaps even slightly extended, in Urbaniak v. American Drug Stores, LLC, 2019 IL App. (1st) 180248 (Ill. App. March 25, 2019). In Urbaniak, the plaintiff had taken Reglan for six years to treat gastroparesis. Unfortunately, the plaintiff developed tardive dyskinesia and dystonia. The prescribing physician admitted that he was unaware of the risk that a patient might develop these movement disorders from long-term ingestion of Reglan. The plaintiff sued that doctor for medical malpractice and separately settled. One might think that is where the tale ends.

It did not end that way here. The plaintiff also sued the pharmacy, and the central issue in that case was whether the pharmacy could be liable for failing to issue an oral warning to the plaintiff about the medical risks associated with the long-term ingestion of Reglan. Why an oral warning? We’ll get to that point. It is a major weakness in the plaintiff’s case. Another weakness was that the plaintiff wanted to prove that the pharmacy should have known the risks about which the doctor was clueless, should have deduced that the doctor was clueless, and should have stepped into the breech and warned the patient.

That seems a trifle ambitious. It also seems more than a trifle wrong.

(Why did the plaintiff not sue the manufacturer? Dunno. Perhaps the plaintiff used a generic version. Or perhaps the plaintiff saw the learned intermediary rule as an insurmountable barrier against manufacturer liability. If the latter, then what happened in Urbaniak becomes even a little more interesting.)

In February 2009, after the plaintiff began taking Reglan, the Food and Drug Administration approved a black box warning for the drug. The black box warning addressed tardive dyskinesia directly. For the six years he took Reglan, the plaintiff had all of his prescriptions filled at the same pharmacy. When dispensing Reglan, the pharmacy distributed a medication guide to consumers. The medication guide for Reglan provided warnings and other information about the drug, including the warning about tardive dyskinesia. But the pharmacy never orally warned the plaintiff about the risks associated with taking Reglan longer than 12 weeks. Do you see where this is going?

Why would the pharmacy butt in and nag the plaintiff? That must be what the pharmacy thought when it moved for summary judgment on the claims against it. The pharmacy argued that it had no duty to warn the plaintiff or his doctor about the risk of developing tardive dyskinesia and dystonia as a result of taking Reglan for longer than 12 weeks. The trial court agreed and entered summary judgment in the pharmacy’s favor. The plaintiff appealed.

The Illinois appellate court reasoned that the learned intermediary doctrine obligates drug manufacturers to warn only physicians about the potential risks of a drug, and then physicians are required to use medical judgment to determine which warnings to provide to patients to whom the drug is prescribed. The duty to warn of side effects is not placed on the pharmacist, it is placed on the prescribing physician. A pharmacist owes just a duty of ordinary care in practicing his or her profession.

The issue in Urbaniak was not whether the pharmacy had a generalized duty to warn the plaintiff about the dangers of Reglan, because it did so in writing. (Remember the medication guide?). Rather, the issue is whether the pharmacy had a specific duty to advise the plaintiff orally about the risks of the prolonged ingestion of Reglan or to advise the prescribing physician about the risks of taking Reglan long term. That makes the Urbaniak case slightly different from prior Illinois cases. It makes Urbaniak weirder. We think it also makes Urbaniak easier.

The plaintiff argued that it is “highly unusual” for a black box prescription warning to have a time limitation – 12 weeks in this case – and that the pharmacy should have told both the prescribing doctor and the patient “about the 12 week warning so they could have evaluated whether to continue the drug.” The plaintiff argued that the pharmacy owed a duty “to be aware of the black box time limitation, to make sure that the refill does not exceed the limitation, and if it does, discuss that issue with the doctor or patient.”

The appellate court sensibly concluded that such a rule would require pharmacies to inquire into the doctor’s judgment about, at a minimum, the duration of prescriptions when side effects could develop from long-term use. Such a rule would run afoul of Illinois court decisions that have “consistently declined to impose upon a pharmacy, any duty to monitor patients, make medical decisions, or to warn a physician or a patient of ‘excessive’ prescribed doses.” Illinois law imposes “no duty on a pharmacist to warn the customer or notify the physician that drugs are being prescribed in dangerous amounts, that the customer is being overmedicated or that various drugs in the prescribed quantities could have an adverse effect.”

Again, the pharmacy did warn the plaintiff about the dangers of taking Reglan for longer than 12 weeks. It just did so in writing. The plaintiff argued that the pharmacy should have been done orally, as well. That is not a theory of liability the appellate court would accept. The plaintiff admitted that he never read the medication guide given to him with his prescription. The plaintiff seemed to want a nanny at every turn. He demanded that the pharmacy should have waded further into the situation. But, according to the appellate court, “the learned intermediary doctrine dictates that pharmacists stay out of the physician-patient relationship.”

(Some of you might be thinking that Urbaniak smells like assumption of the risk, contributory negligence, or a break in the failure to warn claim inasmuch as the plaintiff either 1) read the warning and accepted the tardive dyskinesia risk without any questions, 2) read the warning, discussed it with the doctor he later sued, and accepted the risk, or 3) never read the medication guide at all. All of that points to personal responsibility, which this plaintiff threw away with the medication guide.)

Moreover, the pharmacy had no reason to know that the doctor was ignorant of the effects of the drug for which he wrote a prescription. It is not as if the pharmacy was saddled with an “independent duty to inquire into the doctor’s pharmaceutical competence.” It is the doctor’s duty to know what he is prescribing and it is the pharmacy’s duty to give the patient what the doctor orders.

There is another way to style the plaintiff’s claim in Urbaniak. To fit within Illinois precedents, the plaintiff tried to make the case that Reglan should be considered contraindicated for anyone after 12 weeks of use. Consequently, per this line of reasoning, the pharmacy was required to speak up about such contraindication. But contraindications ”speak in terms of specific patients and specific treatments. Reglan was not specifically contraindicated for the plaintiff for any articulable reason. The plaintiff presented with no allergy and there was no concern about the interaction of multiple drugs in this case.”

The pharmacy simply had no duty to speak.

As we approach the end of the year, we turn to reflecting on the events of the passing year.  We do it here on the DDL blog with our best of and worst of posts.  It is often a time to consider just how much (or how little) was accomplished in the course of a year.  How much has changed (or stayed the same).  In any event, a year marks a significant passage of time.  Enough time to say – file a complaint with sufficient facts to support your claims (or not).

In Winkler v. Medtronic, Inc., 2019 WL 6052702 (D. MD. Nov. 15, 2019), the court was analyzing plaintiffs’ amended complaint.  That’s because almost one year earlier the first complaint was dismissed for lacking “sufficient detail for the Court to determine the applicable limitations period . . . or whether any of the claims are preempted.”  Winkler v. Medtronic, Inc., 2018 WL 6271055 (D. MD. Nov. 29, 2018).  Back then, plaintiffs complained that “a more robust pleading is impossible absent discovery.”  Id. at 4.  The court disagreed.  Specifically, the court noted that plaintiffs had the publicly available FDA Class III information on the device and they retained possession of the allegedly defective part of the device.  Plaintiffs, therefore, had the tools to “exercise[e] due diligence,” amend their complaint, and then allow the court to analyze the question of preemption.  Id. Well, two out of three of those things took place.

Plaintiffs filed their amended complaint.  It contained causes of action for negligent manufacture, failure to warn, breach of warranty, strict liability, and wrongful death.  Winkler, 2019 WL 6052702 at *3.  At issue was a ventricular assistive system that had been implanted in the decedent’s heart to provide ventricular function while decedent awaited a heart transplant.  A power failure caused the device to stop working and decedent suffered a fatal cardiac arrest.  Id. at *1.  The device was a pre-market approved, Class III device.  Having gone through the rigors of pre-market approval, only a parallel violation claim may survive preemption.

Therefore, as an initial matter, the complaint must allege violations of FDA regulations related to the device at issue.  The amended complaint contained only this single sentence with a vague reference to an unidentified FDA-standard:  “Defectively manufactured batteries which fail to hold a charge due to faulty cells violate the standards required by the FDA for premarket approval of the [device].”  Id. at *3.  Where’s the specificity?  Where’s the due diligence?

Simply stating that the defect you allege caused injury also violated a non-specific FDA standard, “is simply insufficient for this Court to infer plausibly that the claims are parallel, and not in addition, to the pertinent FDA regulations.  Id.  That is simply too low a bar to allow plaintiffs to escape statutory preemption.

Not in their amended complaint, but in their response to defendant’s motion, plaintiffs allege that the subsequent FDA recall “saves the claim.”  Id.  Even if that could be considered as part of the amended complaint, it still didn’t solve plaintiffs’ problem of failing to plausibly allege a violation of a specific FDA regulation.  The recall may support that the device was defective, but it “does not shed any light on the applicable FDA regulations” or how those arguably violated by defendant.  Id.

One year ago the court gave plaintiffs a roadmap.  Look at the regulations applicable to the device and look at the device itself.  Allege facts supporting that the device implanted in the decedent deviated from or violated any specific FDA standards.  Use due diligence.  Plaintiffs ignored that advice, added one vague reference to a violation, and tried to toss in the recall at the last minute.  In other words, since last year almost nothing changed.  So, neither did the result.  Case dismissed.

In prescription medical product liability litigation, size matters.  It doesn’t matter as much as having good products and winning arguments, but when the name of the game on the other side is to drag defendants into pro-plaintiff forums and then use every procedural trick in the book to try to “ring the bell” on some questionable legal theory, then size can matter a lot.

A case in point.  Remember that string of shockingly large talc verdicts that spewed forth from St. Louis a couple of years ago?  Well, not too long ago the largest of them – a $110 million whopper – went “poof.”  See Slemp v. Johnson & Johnson, ___ S.W.3d ___, 2019 WL 5151278 (Mo. App. Oct. 15, 2019).  Turns out, there was no personal jurisdiction in the first place.  The plaintiffs’ procedural gambit of joining scores of miscellaneous plaintiffs from all over the country with one St. Louis plaintiff was both unconstitutional and contrary to the rules of procedure:

[Defendants] argue [plaintiff’s] claims did not give the trial court personal jurisdiction over [defendants].  Both parties agree this case is governed by this Court’s prior cases, Estate of Fox v. Johnson & Johnson and Ristesund v. Johnson & Johnson, 558 S.W.3d 77 (Mo. App. E.D. 2018).  Both of those cases involved plaintiffs who were not residents of Missouri who had joined their claims with those of Missouri residents.  In those cases, . . . the United States Supreme Court decided BMS, which clarified the existing law on specific personal jurisdiction requiring the trial court have personal jurisdiction over the defendants with regard to each claim, rather than establishing personal jurisdiction by allowing non-residents to join similar claims with those of Missouri residents.  In Fox and Ristesund, this Court found that, due to the advanced procedural posture of the cases, remand was inappropriate as the plaintiffs had had ample opportunity to present all arguments for personal jurisdiction to the trial court and were unable to do so successfully.

Id. at *3.  Indeed, the error was so evident by the time Slemp was decided that the plaintiffs admitted it:

[Plaintiff] concedes that . . ., the record establishes that, per BMS, the trial court lacked personal jurisdiction over [defendants].

Id. at *4.

There’s one other thing, though.  To get to that point, the same defendants had to appeal – and win – the two previous cases, Fox (discussed here) involving a $72 million verdict, 539 S.W.3d at 50, and Ristesund (discussed here) a verdict of $45 million, 558 S.W.3d at 79.  Actually, there are billions of other things, because also hanging over these defendants’ heads during these appeal was a $4.7 billion verdict in an almost certainly improperly consolidated trial of 22 plaintiffs – a trial that also suffers from the same jurisdictional deficiencies that made the Slemp, Fox, and Ristesund verdicts not worth the paper they were printed on.  That blatantly prejudicial consolidation occurred in the same court that, in Slemp, was held to have committed another procedural impropriety when it purported to revoke with defendants’ appeal rights retroactively.  Slemp, 2019 WL 5151278, at *2 (“the trial court’s authority to amend its August 3, 2017 judgment on its own motion ended 30 days after the judgment was entered, well before it did so on November 29, 2017, when it revoked the Rule 74.01(b) appeal certification”).

Thus, in order to vindicate their Due Process rights regarding personal jurisdiction in these matters, the defendants had to litigate with over $5 billion in potential liability hanging over their heads.  Not too many defendants have the wherewithal (or the mindset) to do that.  And this isn’t the first time.  We’ve chronicled the misadventures of repeated multi-plaintiff “bellwether” show trials in the Pinnacle Hip MDL.  That involved another Johnson & Johnson subsidiary, and saw other nine and ten figure verdicts – the only one actually appealed to decision being reversed.  In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753 (5th Cir. 2018).  Another Fifth Circuit decision, on mandamus, characterized some of the MDL judge’s procedural rulings as “grave error.”  In re Depuy Orthopaedics, Inc., 870 F.3d 345, 351 (5th Cir. 2017).  Ultimately, that MDL settled – we assume for a lot less than these verdicts suggested − after the Fifth Circuit indicated that it might consider removing the MDL judge.  888 F.3d at 792 n.83.  So once again, size mattered.  J&J was able to vindicate its procedural rights (and many of its legal positions) only by litigating in the shadow of billions in questionable liability judgments.

That’s the way the game is unfortunately played in all too many jurisdictions these days.  Multiple plaintiffs, often aided by procedures of questionable Due Process constitutionality, strive to bring back verdicts in the hundreds of millions or even billions of dollars.  Any defendant hit with one of those is then subjected to what courts have referred to as “hydraulic pressure” to settle in order to “avoid[] the risk, however small, of potentially ruinous liability.”  E.g., Hevesi v. Citigroup Inc., 366 F.3d 70, 80 (2d Cir. 2004); Newton v. Merrill Lynch, Pierce, Fenner & Smith, Inc., 259 F.3d 154, 192 (3d Cir. 2001).

Size matters.  There aren’t that many defendants out there big enough to risk the burden of a half-billion “public nuisance” verdict under a statute so vague as to raise constitutional questions (among many other issues), or to take on another “Philly Special” – billions in purported punitives over an alleged drug adverse effect that isn’t even a physically disabling condition.  See Byrd v. Janssen Pharmaceuticals, Inc., 333 F. Supp.3d 111, 124 (N.D.N.Y. 2018) (“it is undisputed that gynecomastia was not a ‘serious’ hazard pursuant to [FDA] regulations”).

Thus, as long as mass torts continue piling up in jurisdictions that plaintiffs like, size will continue to matter, and in some cases may even be a prerequisite to obtaining justice.

We have always wondered why judges are hesitant to sever the claims of plaintiffs who never should have joined their claims together in the first place.  You know what we mean—multiple plaintiffs, sometimes dozens of them, who join their claims together in one complaint based only on the allegation that they used the same or similar products.  This is not only about avoiding filing fees (although it partly is).  Plaintiffs and their attorneys frequently use improper joinder to manipulate the forum and evade federal jurisdiction.  That occurs when multiple plaintiffs whose claims unquestionably presented complete diversity of citizenship combine their claims into one complaint with one or more plaintiffs whose citizenship is not diverse with one defendant.

The proper approach here is to sever the separate plaintiffs’ claims so each can proceed on its own, and a recent case in California illustrates the two ways by which to do that.  In Kline v. Mentor Worldwide, LLC, No. 2:19-cv-00877, 2019 WL 3245102 (E.D. Cal. July 19, 2019), plaintiffs from California, Pennsylvania, Mississippi, and Florida sued Pennsylvania and California defendants alleging personal injuries from breast implants.  As you might expect, each plaintiff had her own story—different doctors, different alleged injuries, different procedures over extended periods of time, etc.—so the defendants removed the case to federal court.

But what about the lack of complete diversity?  The defendants urged the district court to (1) find the California defendant (a holding company that neither made nor sold a product) fraudulently joined and (2) asked the district court to sever the claims of the individual plaintiffs, who were completely unrelated.  This is the first way to address the improper joinder of unrelated plaintiffs—remove to federal court and argue “fraudulent misjoinder” (which is different from “fraudulent joinder”).  We explained fraudulent misjoinder in some detail in one or our earliest posts here, but in short it just means that the district court should sever the individual plaintiffs’ claims and retain jurisdiction over those where there is complete diversity.

That is what the district court in Kline should have done, but it only partly delivered.  To begin, the district court found that the plaintiffs had fraudulently joined the California holding company because “plaintiffs have not articulated any legal theory under which they could potentially recover against defendant [holding company].”  Id. at *4.  The California holding company’s citizenship therefore was disregarded.  Id.

The district court deferred, however, on whether to sever the plaintiffs’ claims as misjoined.  It mattered for diversity jurisdiction because there were still a Pennsylvania plaintiff and a Pennsylvania defendant left in the case.  But the district court decided that the state court on remand “could evaluate the propriety of joinder under state law.”  Id.  The district further observed that “[i]t does not appear that doing so will frustrate defendant’s statutory right of removal in the event that the state court should subsequently severe plaintiffs’ claims.”  Id.

It seems to us that remanding under these circumstances was unnecessary, especially where the district court expressly contemplated that the case might be removed again.  But the order does lead us to the second way to address the improper joinder of unrelated plaintiffs—file a motion to sever in state court.  That is what the defendants did on remand, and it worked.  Citing the binding authority of David v. Medtronic, 237 Cal. App. 4th 734 (2015) (which came in fourth on our top drug and device opinions list for 2015 and which you can read more about here and here), the state trial court ruled that plaintiffs are not properly joined where they are merely implanted with the same medical device during different surgeries performed by different surgeons who had different levels of knowledge.  Kline v. Mentor Worldwide LLC, No. 34-2019-00255852-CU-PL-GDS, Slip op. at 2 (Cal. Superior Court Nov. 13, 2019).  In so ruling, the state court cited the plaintiffs’ different residences, different procedures at different times, and their different alleged injuries.  Id.  The state court also rejected the argument that an alleged failure to follow FDA regulations and report adverse events was sufficient to support a finding that the plaintiffs’ surgeries were “part of the same series of transactions.”  Id.  Moreover, the duty to report adverse events was not the same for each plaintiff’s case anyway because of different requirements at different times.  Id.

In the end, the state court ruled as follows:

Under these circumstances, the Court finds that Plaintiffs have not alleged a single scheme, depending on the same misrepresentations, and leading to transactions exactly similar in kind and manner of operation.  [citing David v. Medtronic].  The Court finds that Plaintiffs’ separate surgeries, conducted at different times by different physicians in different states, are separate and distinct transactions.  Accordingly Plaintiffs were not properly joined under Code of Civ. Proc. § 378 and severance is proper.

Id.  This is the correct result, and we will return to our opening observation:  Why are court hesitant to enter orders like this one?  We don’t know.  We do know that the federal district court in Kline expressed its view that the defendants could remove again if the state court severed the plaintiffs’ claims, which it did.  We also know that the federal district court has already ruled that the California holding company defendant (a forum defendant) was fraudulently joined.  We like the defendants’ chances going forward.