We write on a lovely Sunday afternoon, much of which was devoted to trying to figure out what the oldest of the Drug and Device Law Little Rescue Dogs would deign to eat.  We should note that we would do literally anything for this frail, scruffy angel incarnate.  To wit, we have cooked fresh beef and chicken for every meal since she started refusing dog food.  Then, starting yesterday, she refused to eat the beef and chicken, even fed by hand.  We tried other delicacies without success.  Then we panicked.  In desperation, we opened a can of dog food (albeit high-end premium dog food).  And she scarfed it down.  Our heart rate has returned to near-normal, notwithstanding the fact that none of this makes any sense.

What does make sense is today’s short and very tidy decision.  In Meade v. Ethicon, Inc., 2021 U.S. Dist. LEXIS 179320 (E.D. Ark. Sept. 21, 2021), a case remanded to the Eastern District of Arkansas from the pelvic mesh MDL, the plaintiff sued the manufacturer of her mesh device, asserting the usual “kitchen sink” litany of claims.  The court had already granted summary judgment on the strict liability design defect claim and the fraud-based claims, as well as the claims for breaches of warranties, manufacturing defect, negligent infliction of emotional distress, gross negligence, unjust enrichment, and violation of consumer protection laws.  This left only a few claims, among them failure-to-warn claims sounding in strict liability and negligence, and the defendant moved for summary judgment on those claims.

Regular readers of this blog are aware of our fondness for the doctrine of “warnings causation.”  For the uninitiated, a brief explanation:  to prevail on a failure-to-warn claim under the learned intermediary doctrine, a plaintiff must prove both that the warnings accompanying her prescription medical device were inadequate and that the inadequate warning proximately caused her alleged injuries (hence, “warnings causation”).  To prove this element of her claim, the plaintiff must adduce evidence that a different or stronger warning would have altered her physician’s decision to prescribe the device.  If she cannot, then the claim fails, whether or not the warning was adequate.

And there was the rub, for the plaintiff in today’s case.   Because her prescribing physician – the doctor who implanted her mesh device – died before he was deposed, there was not (and never could be) any evidence of how the doctor would have behaved in the face of a different warning.  The plaintiff argued that her medical causation expert cured this void by opining that a “defective sling” caused the plaintiff’s injuries.  But the court wouldn’t bite, holding that the expert could not “offer testimony as to whether [the implanter] relied on the inadequate warning defendants provided with the . . . device or whether [he] would have acted differently had he been aware of the risks or had he been given an adequate warning.”  Meade, 2021 U.S. Dist. LEXIS 179320 at *11 (citations omitted).  The court concluded, “Without testimony from [the] implanting physician, there is no triable issue of fact on causation as to plaintiff’s failure to warn claims that can withstand summary judgment.”  Id. (citations omitted).  While we would tinker with the grammar of that statement, we cannot quibble with its conclusion.

We understand that some may lament a decision that penalizes the plaintiff for her doctor’s untimely death.  In this case, the plaintiff apparently allowed the whole discovery period to elapse without deposing the doctor.  When the omission came to light, the doctor had died.   Moreover, in any event, giving the plaintiff a “pass” on proving an essential element of her claim would be profoundly unfair to plaintiffs who find themselves out of court because of their (living) doctors’ unfavorable or inadequate testimony.  So often, courts muddy the law of “warnings causation,” shifting the burden of proof to allow deficient claims to proceed.  We applaud the Meade court for avoiding this trap.

That’s the main lesson of the emerging fiasco that is the ALI’s benignly named “Concluding Provisions” project for the Restatement Third of Torts.  While this title suggests that the Institute is merely engaged in routine “mop up” work, nothing could be further from the truth.  Any number of significant tort-related topics were not addressed by prior Restatement Third projects, such as:

Medical malpractice and informed consent;

Sovereign immunity;

Implied statutory rights of action;

Statutes of limitations;

Wrongful death and survival actions

Wrongful birth/life and actions for harm to a fetus;

Vicarious liability;

Insurance bad faith;

Government contractors;

Spoliation of evidence as a tort;

Dram shop liability;

Contractual releases of liability.

The “Concluding Provisions” project intends to cover all of these topics, and more.  Restatement of the Law Third Torts:  Concluding Provisions, Preliminary Draft #2, at xxiii-xxiv (August 16, 2021).

Basically, we need more defense-minded ALI members to show up.

A combined in person and Zoom meeting of the Concluding Provisions Advisers and Members Consultative Groups took place at the ALI’s West Philadelphia headquarters on September 9-10.  A lot happened at that meeting, and not much of it good from our defense-oriented standpoint.  For instance, disclosure of confidential patient information would become a form of medical malpractice, id. at 245, and informed consent would include any “other relevant information that the provider is aware the patient reasonably wants to know.”  Id. at 306.  Lawyers defending health care providers beware.

More relevant to our neck of the woods − both innovator liability and medical monitoring were on the agenda.  As to innovator liability, see id. at 70-71 (comment o, allowing innovator liability), 83-84 (reporters’ notes stating the courts dismissing innovator liability claims “fail to appreciate that there is a non-product liability claim that exists for negligent misrepresentation that does not require the relationship that product liability claims do”).  That’s right, even though only one jurisdiction in the country allows branded drug manufacturers to be sued in negligence for misrepresentations in generic drug labeling, see our scorecard here, this “Restatement” proposal would allow it.  As to medical monitoring, see id. at 369-409 (proposing to recognize liability for medical monitoring in the absence of any present injury even though “approximately half [of jurisdictions] permit recovery, while approximately half do not, and there is no clear trend either for, or against, acceptance”).

Despite these disturbing − at least from the perspective of those who oppose universal tort liability – proposals, practically nobody who shared our perspective bothered to attend the meeting.  Besides Bexis, one recognizable defense-side name usefully participated in the innovator liability discussion on Thursday, but then was absent when medical monitoring was discussed on Friday.  Two other recognizable defense-side names participated in the medical monitoring discussion, but only one actually opposed the proposal for the ALI outright to recognize that controversial tort.

We’re left wondering, where were all those ALI members who agree with us that:  (1) innovator liability is an existential threat to the branded drug industry, and (2) allowing every uninjured, allegedly at-risk person to sue for medical monitoring is bad legal policy and worse allocation of societal resources?  It’s not like the ALI’s proposals were a secret.  Any ALI member can join a Members Consultative Group.  The relevant draft was publicly available for weeks to any ALI member who cared to take a look.  The pro-liability side was out in force – both lawyers for the left side of the “v.” and academics whose temperament and economic interests favor ever-increasing liability and litigation.  They were numerous, vocal, and well spoken.  We admire their commitment, as much as we disagree with their positions.

We wish we saw similar commitment from defense-minded colleagues.  The ALI’s ethos is that members “leave their clients at the door.”  That doesn’t mean, however, leaving one’s own views at the door, and it does require actually walking through the door.  Unfortunately, our side went virtually AWOL.  There must be a couple dozen ALI members at the big defense firms in Philadelphia (including ours – nobody is exempt from this critique), who could have attended in person.  Probably twice as many right side of the “v.” potential ALI advocates reside/work the AMTRAK northeast corridor between Washington, DC and New York City, and could have hopped the train.  And any ALI member, anywhere could have participated via the ALI’s (sometimes glitchy) Zoom connection.

Frankly, it’s damn frustrating banging one’s head against that ALI wall with little or no support – even before an ALI representative decides to put another thumb on the scale in favor of increased liability.  It’s no fun getting your head handed to you for seven hours straight.

Bexis proposed to delete all references to innovator liability from the section on negligent misrepresentation and to replace the ALI’s endorsement of medical monitoring with “yes” and “no” alternatives that would accurately reflect the current state of legal equipoise.

In connection with the innovator liability issue, Bexis provided the reporters with links to both the Blog’s innovator liability scorecard and our 50-state survey on innovator liability, which compiles caselaw rejecting innovator liability from 49 states, the District of Columbia, and Puerto Rico.  While the Reporters will “consider” this caselaw, it is by no means certain at this point that they will follow the overwhelming majority rule, the Restatement Third of Torts:  Products Liability §9 (1998), and the Restatement Third of Torts:  Liability for Physical & Emotional Harm §7(b) (2010), and delete the endorsement of minuscule innovator liability minority position that appears in the current draft.  Concluding Provisions, Preliminary Draft #2, at comment o, pp. 70-71.

As for medical monitoring, Bexis proposed what the same draft had recommended twice in other situations where the law was in equipoise − §9(c) on informed consent, and comment j on whether medical monitoring was a separate cause of action or a remedy.  His proposal was for the Institute to offer alternative sections reflecting the two alternative results that have been recognized by the courts.

Not this time.  Where the question was liability, yes or no, the pro-liability position was rammed through, consistency be damned.

Yes, an ALI “restatement” need not always respect legal “equipoise,” and can even adopt a minority view if there is strong reason to do so, such as when the distinct trend of recent caselaw is contrary.  Concluding Provisions, Preliminary Draft #2, at xii-xiv.  That isn’t the case here, and even if it were, the discussion in the draft is neither clear nor transparent.  Justice Cardozo famously held that “[n]egligence in the air, so to speak, will not do” to create a tort duty.  Palsgraf v. Long Island Railroad Co., 162 N.E. 99, 99 (N.Y. 1928).  Similarly, Professors Prosser and Keeton believed that “[t]he threat of future harm, not yet realized, is not enough” to support tort liability.  W. Page Keeton, et al., Prosser & Keeton on the Law of Torts §30, at 165 (5th ed. 1984).  The United States Supreme Court rejected medical monitoring for federal causes of action in Metro-North Commuter Rail Road Co. v. Buckley, 521 U.S. 424, 435-36, 442-45 (1997) (FELA case).  So, in recent years, have the highest courts of major states such as New York and Illinois.  Berry v. City of Chicago, ___ N.E.3d ___, 2020 WL 5668974, at *6-7 (Ill. Sept. 24, 2020); Caronia v. Philip Morris USA, Inc., 5 N.E.3d 11, 14 (N.Y. 2013).  The product liability section of the Third Restatement expressly limits recovery for product-related claims “only to harm to persons or property, commonly referred to as personal injury and property damage.”  Restatement (Third) of Torts, Products Liability §1, comment d (1998).

Why are all these conclusions wrong, and the no-injury liability expansionists right?  From the ALI’s draft, it’s very hard to say, particularly since the no-liability view is only presented as a contrary position to be debunked.  The ALI’s draft condescendingly introduces no-liability position:

Notwithstanding these advantages, some courts decline to permit pure medical monitoring claims, and certain commentators promote the more skeptical stance.

Concluding Provisions, Preliminary Draft #2, Medical Monitoring, Reporters Notes to comment b, at 382-86.  Similarly disparaging comments pepper the Reporters’ Notes:  “notwithstanding the above support,” “belied by the evidence,” “objections are overstated,” and “exaggerated,” and thus betray a deep-seated bias in favor of liability.  In support of medical monitoring liability, the notes even invoke a concept, “avoidable consequences,” id. at 381-82, that another section of the Third Restatement abolished.  See Restatement (Third) of Torts, Apportionment of Liability §3, comment b (2000).

It would not be difficult to present a more balanced view of the evenly divided fashion.  Heck, if the reporters couldn’t bring themselves to do it, Bexis even offered to draft a comment presenting the no-liability position himself, since all he’d have to do is update, and maybe expand a bit, his amicus curiae brief in CaroniaSee Brief of Amicus Curiae Product Liability Advisory Council, Inc. in Support of Defendant-Respondent Philip Morris USA, Inc., 2013 NY App. Ct. Briefs Lexis 130 (N.Y. filed Oct. 4, 2013).

Offer refused.  Liability uber alles.

The reporters did, however, seem a bit uncomfortable with untrammeled no-injury medical monitoring claims.  It is, after all, not easy to justify allowing 1,000 people all to sue for medical monitoring when, statistically, only seven of them would ever suffer the claimed risk.  Concluding Provisions, Preliminary Draft #2, Medical Monitoring, Illustration 3, at 374.  We guess that’s supposed to be a “significant” increased risk.  So the draft attempts to “cabin” “unqualified and unbounded” medical monitoring liability with a couple of novel provisions:

(c) the person has incurred the monitoring expense, will incur the monitoring expense, or would incur the monitoring expense if he or she could afford it; and

(d) the actor’s liability is neither indeterminate nor overwhelming.

Id. at 369 (black letter).  Similarly comment m expresses a “preferred approach” for a “court-administered and supervised fund” – something foreign to any other tort that we’re aware of in the Third Restatement, and thus not in harmony with the larger body of tort law.

These attempts to paper over the inherent problems of no-injury medical monitoring claims were strongly attacked by the meeting’s pro-plaintiff contingent as unsupported by the law.  On that point, we’re forced to agree with them.  In trying to dilute the enormity of the legal change they are proposing that the Institute endorse, the reporters created a legal chimera – a set of elements called “medical monitoring” that has not, in fact, been adopted by any state in the country.

Instead, as the draft admits, the states have split evenly between a more expansive form of “medical monitoring” liability and no liability for “medical monitoring” at all.  The overall lack of support for what the reporters have spun as some sort of (non-existent) middle ground is yet another reason why the dual approach is particularly appropriate in this situation.  Nor does would-be subsection c’s removal of medical monitoring from the collateral source rule make sense from a policy standpoint.  Why should the ALI advocate for creating a new system of litigation, with all its attendant costs and inefficiencies, given that only a small percentage of potential plaintiffs would be out of pocket for monitoring costs?  Only lawyers always appear to benefit.  Or is medical monitoring to become a subrogation stalking horse for insurance companies?

We could go on – Bexis did go on at the recent meeting, but it was awfully lonely.  If ALI members with defense oriented viewpoints (and in-house members, too, if there are any) aren’t going to show up, then we’re just shouting into the void.

As we age, we sometimes forget how things used to be.  It is not just age-related deterioration of the synapses in our hippocampi.  (We do question why hippocampi and hippopotamuses are the preferred plural forms these days and why more anatomic structures are not named for things like seahorses.)  There is also a recency effect.  In our area of the law, we do not often pine for the “good old days,” at least on this side of the v.  While not as pronounced as in civil rights, where there clearly was a time when the law of the land was a travesty, the old days of defending drug and device product liability was not better, at least in terms of the law on the books and how it was applied.  For instance, we recall defending cases in Texas court over alleged cardiac injuries when (1) the chances of successful removal were slim, (2) motions to dismiss on adequacy of pleadings were useless, and (3) the substantive Texas law was pretty plaintiff-friendly, especially as applied by elected state judges and many appointed federal judges (who often used to be elected state judges).  Harris v. Medtronic, Inc., No. 3:20-CV-1407-S, 2021 U.S. Dist. LEXIS 178827 (N.D. Tex. Sept. 20, 2021), shows how things have changed for the better.

Harris is a case where the plaintiff had an aortic valve replacement surgery and, subsequently, was placed on defendant’s temporary external pacemaker, specifically something called an external pulse generator (“EPG”).  We can surmise that the EPG was necessary because the plaintiff’s heart rhythm was not otherwise stable, creating a risk of various problems like atrial fibrillation, stroke, sudden cardiac death, and cardiac arrest.  Unfortunately, despite the EPG, he suffered the last of these, from which he survived but claimed continuing injuries.  About two years after his cardiac arrest, he sent a notice of claim to the out-of-state manufacturer and he and his wife sued it and some non-diverse defendants (healthcare providers, we assume) in Texas state court.  After the non-diverse defendants were dismissed a bit less than a year later, the manufacturer successfully removed the fully diverse case to the Northern District of Texas.  The removal may seem pretty rote now, but it was not so in the 1990s and early 2000s.  Those non-diverse defendants tended to get dismissed more than a year after the case had been filed and many federal courts in Texas were disinclined to find fraudulent joinder of even the most obviously bogus defendants.  But, in 2020, this case stuck in federal court.  Then the plaintiffs amended their complaint twice and the remaining defendant teed up a TwIqbal motion.

Twombly was decided in 2007 and Iqbal in 2009.  Together, they changed things a bit.  On the plus side, boilerplate allegations should not be enough to get past a 12(b)(6) motion in federal court.  We have not seen data on this, but we strongly suspect the success rate of such motions after Iqbal is probably twice what it was before Twombly.  On the downside, many plaintiffs file crazy long and confusing complaints to try to overwhelm courts and suggest that they have specific factual allegations to back up their claims.  In addition, courts tend to give plaintiffs multiple chances before dismissing cases (or even some of the claims) with prejudice.  The rule of thumb seems to be three strikes and you’re out.

The other change relates to Texas law.  Although the Texas Product Liability Act dates to 1993, there were major changes in 2003, including damages caps.  Again, this is our speculation based on anecdote and observation, but there appears to be far less drug and device product liability litigation in Texas these days and it seems that the application of legal requirements for such claims is tighter.  One might think that an overloaded court system, as Texas state courts were often labeled pre-2003, would lead to higher bars for getting to trial, but the opposite seems to be the case.  Accuse us of being defense hacks if you wish, but we tend to like strict application of the rules and requirements (e.g., evidence supporting each element of a cause of action to get past summary judgment).  Harris gave us that, starting with a recitation of the TwIqbal requirements and a dive into the three versions of strict liability available under Texas statute.

First up was manufacturing defect.  Texas law requires deviations from specifications that render the product unreasonably dangerous.  Id. at **6-7.  Rather than identify a specific defect present in plaintiff’s device, the operative complaint offered a few possibilities of general things that “may have” happened in manufacturing the device, without ever specifying the actual specifications.  Id. at *7.  This was insufficient in terms of defect, deviation, and causation.  In essence, this was an attempt to pervert the res ipsa loquitur doctrine to establish a manufacturing defect from an alleged malfunction.  That does not fly under Texas law these days.

Next up was “marketing defect,” which is really just a warnings claim.  Plaintiffs were required to plead specific inadequacies in the warnings to doctors and that such inadequacies caused the alleged injuries.  Instead, plaintiffs offered a laundry list of possible failure mechanisms (combining their manufacturing defect and design defect lists) and claimed the “user” was insufficient warned of them.  Id. at **9-10.  These “conclusory” allegations were insufficient, as plaintiffs never identified what warnings were included and how they were presented to allow an assessment of their inadequacy.  Similarly, the causation allegation was just that the doctor would have picked another product without any factual allegations to back it up.  Id. at *11.  The court went a step further and concluded that the warnings actually provided with the device were adequate as to the risk of the harm allegedly suffered by plaintiff.  Id. at **11-12.  It is unusual for a court to reach such a conclusion in the 12(b)(6) context, but the court here explained that it could do so based on the record before it (without converting to Rule 56 motion).  Id. at *11 n.1.

For design defect, Texas requires the plaintiff to prove defect, unreasonable dangerousness, causation, and the existence of a safer alternative design.  Have only a laundry list of possible failure mechanisms, plaintiffs did not get off the ground.  “Plaintiffs have pleaded the EPG malfunctions without pleading a design defect.”  Id. at *13.  Alleging that the device could have been designed without these alleged design defects was not enough either.  (The court did not need to go further, but we found the allegation of “degradation” to be particularly dubious in this case where the injury occurred a day after use began.  We guess it is just standard now to throw in some “degradation” theory with every medical device these days.)

The TPLA does not abrogate common law negligence, but logic still applies.  If plaintiffs could not articulate supported claims for any defect in manufacture, design, or warnings, then re-casting the same stuff as “negligent” was not going to work either.  Id. at **15-16.

Last was the claim for breach of implied warranty of merchantability.  That had two problems.  The first was that plaintiffs based their claim on the same allegations of manufacturing, design, and marketing (warnings) defect.  Id. at *17.  That failing was just as fatal to implied warranty as it was to the negligence claim.  The second and independent problem was that Texas requires timely notice of such a claim and plaintiffs waited almost two years.  They tried to claim “they were not aware of the malfunction” until an unspecified time after their injury, but that directly conflicted with plaintiffs’ attempt to apply res ipsa.  For that, they argued, essentially, “that the defects in the EPG were so clear that nothing could explain what happened to Mr. Harrison except that the EPG was defective.”  Id. at *19 (emphasis in original).  They could not have it both ways and the court found that notice was not timely.

That brings us to the part of the decision we do not like.  Without any analysis, the court granted plaintiffs leave to file an amended complaint within three weeks.  No limit was imposed on its content.  There are two problems with that from our perspective.  First, the court dismissed the plaintiffs’ third complaint.  They had enough swings to assert something more than conclusory allegations that a cardiac arrest during use of a product designed to help prevent cardiac arrest must equate to liability.  Second, the court made two affirmative findings that further amendment cannot undo.  The warnings with device were adequate, which should end the strict liability marketing defect claim and parts of the negligence and implied warranty claims.  Not that any of the implied warranty claim should still be viable given the finding on untimely notice.  So, if plaintiffs were going to get another shot at a complaint, then the available claims should have been limited.  Maybe the plaintiffs will not try again, saving the defendant from having to prepare another motion to dismiss and the court from having to write up another order granting it.

We’ll admit it: this post is written out of pure jealousy. Last week, Tauber authored a post on vaccines and set a record for DDL blogpost “hits.” It was a good, useful post, but we doubt all of the tens of thousands of hits came from legal scholars. The post made it to Reddit, and many of the comments went off on the availability of fried butter, fried Oreos, and fried anything at state fairs. This was fascinating stuff. But, of course, it was the political dimension that launched the vaccine post into the stratosphere. Because of COVID-19, where one stands on vaccines now plays a role in defining whether one is on Team X or Y (or Team Red or Blue). That is a depressing fact of life. To enlist science or anti-science in aid of base political objectives seems about the dumbest thing since innovator liability or the parallel claim exception to express preemption. But there it is, so here we go, reporting on a recent Vaccine Act decision by the Pennsylvania Superior Court.

The case is Sullivan v. Holy Redeemer Hospital and Med. Center, 2021 PA Super. 191 (Pa. Super. Ct. Sept. 24, 2021), and it brings more light than heat to the subject. That is, the Sullivan court got the vaccine issue right. It got it right by reversing a bad decision by the trial court. The plaintiff was a nurse manager who had been administered a tetanus vaccine (so all you COVID controversialists can rest easy for now) and experienced serious and long-term shoulder pain. She sued the hospital for medical malpractice. The defendants moved to dismiss the claim on the theory that it was barred by the exhaustion of remedies requirement Vaccine Act. The plaintiff argued that her injury was not “vaccine-related” under the Vaccine Act, because the negligence was in the injection, rather than the content of the vaccine. The trial court denied the motion to dismiss, and the defendants filed an interlocutory appeal. The Superior Court reversed the trial court’s ruling and directed that the case should be dismissed for lack of subject matter jurisdiction by virtue of the Vaccine Act’s exhaustion of remedies requirement.

Before suing, a plaintiff is required to seek compensation through the Vaccine Act’s mechanisms. Why? The Superior Court observed that the purpose of the Vaccine Act was “two-fold: to expedite compensation for vaccine injuries and to protect vaccine manufacturers from litigation that jeopardized the vaccine supply.” A person who claims to have suffered an injury after receiving a vaccine covered by the Vaccine Act “may obtain compensation from the Program without proving any negligence or defect by proving that the vaccine caused the injury or by demonstrating that her injury is an injury listed as associated with that vaccine in the Vaccine Injury Table created under the Vaccine Act, which creates a presumption of causation.” Vaccine injuries are taken out of the civil tort system and are funneled into a non-litigation system in which recoveries are easier and smaller. Again, why? Isn’t this process a recognition that litigation is too expensive, too unpredictable, and, ultimately, constitutes a disincentive for innovation and manufacture of medical products?

Why confine a more efficient, predictable system to vaccines? To be sure, vaccines deal with contagious diseases, so social externalities are much more of a concern. Society needs people to get vaccinated, and needs to remove barriers to both the supply and demand sides. Fear is the enemy. And, as we are seeing right now, it is a formidable enemy. So is stupidity. All that being said, society has an interest in the development of all sorts of medical prophylactics and therapies. We have written frequently on vaccine preemption. Here, for example. We even have a vaccine cheatsheet. We have long thought that the vaccine system should cover other medical treatments. Perhaps it could be extended to oncology drugs. Then other medical products. Eventually, we would have to switch our legal practice to antitrust, corporate control battles, or commercial disputes. Or we could beg the Chester County DA’s office for a job prosecuting DUIs, shoplifters, and weenie-waggers. We’d be okay with that.

But back to the Sullivan case. That the plaintiff’s shoulder injury was caused by alleged negligence in the injection, rather than by anything inherent in the vaccine itself, doesn’t matter because these type of shoulder injuries are included on the Vaccine Act’s table of compensable injuries. The allegation that the plaintiff suffered reflex sympathetic dystrophy (RSD) syndrome to her shoulder does not remove the claim from the Vaccine Act, and in fact RSD claims have been compensated. Even if RSD was somehow out of bounds, the other injuries the plaintiff alleged are Vaccine Act reimbursable. Those injuries were all sustained “in association with the vaccine.” As the Sullivan court held, “[a]n injury is vaccine-related and is subject to the Vaccine Act if the vaccine was a cause of the injury, even if the only tortious conduct alleged against the defendant is unrelated to the content of the vaccine.”

The regulatory history concerning the Vaccine Injury Table confirmed that claims for shoulder injuries from a negligently administered vaccine are claims for vaccine-related injuries that are subject to the Vaccine Act. In July 2020, the Trump HHS proposed removing shoulder injuries from the Vaccine Act. Under that proposal, the plaintiff’s end run around the exhaustion requirement would have succeeded. But that proposal never became law. In April 2021, the Biden HHS rescinded the proposed revision and left shoulder injuries as being associated with vaccines. In rescinding the proposal, HHS stated that it did so “because it is concerned that [the revision] would have a negative impact on vaccine administrators” and noting that the removal of conditions from the Vaccine Injury Table “could negatively impact the vaccine administrators carrying out this massive COVID-19 vaccination campaign by increasing their exposure to liability for administering non-COVID vaccines.” So, you see, we ended up talking about COVID after all. (We criticized the HHS effort to remove shoulder injuries from the Vaccine Act here, and reported on its ultimate failure here.)

Now bring on Reddit.

It’s football season!  That means beautiful fall weather, tailgating, pots of chili, rooting your favorite team to victory, and wallowing in their losses.  It’s Army v. Navy and Ohio State v. Michigan.  It’s Packers v. Bears and Steelers v. Ravens.  If you are a true fan of the game, it doesn’t matter that in a 3-and-a-half-hour game there are only actually 11 minutes of action.  The other 199 minutes are for second guessing the coach, yelling at the other team, drink refills and bathroom breaks.  You wear your jersey, you paint your face, you stand in the frigid cold in the middle of December in Wisconsin.  And at the end of 18 weeks, no matter how your team did, you know you’ll do it all again next year.

Well, it wouldn’t be football season without some words of wisdom from the great Vince Lombardi Jr. – Football is a game of inches and inches make the champion.  Too true for football.  Partially true for summary judgment decisions.  Winning summary judgment doesn’t get you to the end zone, but legal battles too can be games of inches.  Like when a defendant moves for summary judgement on manufacturing defect, design defect, failure to warn, fraud, and punitive damages and when the dust settles all that is left is a design defect claim built on less than solid evidence of causation.  Plaintiff may have moved the chains, but he’s still got a long drive to be in scoring position.

Today’s matchup is Jarrett v. Wright Med. Tech., 2021 U.S. Dist. LEXIS 180843 (S.D. Ind. Sept. 22, 2021).  The opponents have been delayed in facing off because the case, filed in 2012, was part of an MDL until it was remanded in 2018.  Plaintiff underwent a hip replacement in 2006 in which his surgeon chose to use defendant’s medical device.  Id. at *8.   After a fall four years later, plaintiff had to undergo a revision surgery during which it was determined the device had loosened and rotated.  Id. at *16.  Plaintiff now alleges that a design defect caused the loosening and caused excessive metal ion release.  Id. at *1.  The device was explanted, but not tested or retained.  Pathology tissue samples from the revision surgery, however, did not show the presence of metallic particles.  Id. at *16.

Products liability claims in Indiana are governed by the Indiana Products Liability Act (“IPLA”).  While plaintiff originally pleaded a manufacturing defect claim under the IPLA, he abandoned it in his response to the summary judgment motion so that claim was dismissed.  Id. at *22n.2.  On design defect, expert evidence is required.  Id. at *25.  So, the first question for the court was whether plaintiff had proffered sufficient expert evidence to raise a genuine factual dispute on design defect.  The court found that he did.  Plaintiff’s expert offered an opinion on the components used to make the device, on the metal-on-metal design of the device, and on the testing of the device all which he claims led to a defective design.  Id. at *26.

But that only got plaintiff 5 yards.  He still needed evidence of causation to convert.  Here, the court acknowledge it was a “closer question.”  Id. at *27.  No testing of the explanted device was done and no metal was found in his pathology.  Id.  Plaintiff’s experts relied on two things to establish causation.  First, that the post-operative diagnosis was a “pseudotumor related to metal-on-metal articulation.”  Id. at *28.  But further investigation revealed the suspected pseudotumor was in fact not.  Id. at *29.  That left the court to find that plaintiff’s expert’s claim that “hallmark signs of metallosis” were present created a jury question on causation despite the lack of contemporaneous evidence.  Id. at *29-30.

No contemporaneous evidence.  Sound familiar Bears fans?  Let’s take a short detour to the November 5, 1989 Bears v. Packers game.  Chicago was winning with just seconds left when the Packers’ quarterback, Don Majkowski, threw a touchdown pass to Sterling Sharpe.  An official, however, thought that Majkowski had crossed the line of scrimmage before throwing the ball.  On review, the replay official ruled that — even without clear indisputable video evidence — Majkowski was behind the line and awarded the touchdown (and victory) to the Packers.  I bet that still stings.

While that was the end of that game, our decision goes on and the rest goes in favor of the defense.  For instance, plaintiff’s failure to warn claim was dismissed.  The Instructions for Use that accompanied the device warned of the very risk that plaintiff alleges occurred – the wear of the metal components, the potential of a reaction to particle release, and the loosening of the components.  Id. at *31-32.  Leading the court to find that defendant’s warnings were adequate as a matter of law.

But, even if they were not, plaintiff’s failure to warn claim fails on causation.  Plaintiff’s surgeon, the learned intermediary, was independently aware of the risks alleged to have caused plaintiff’s injuries.  Id. at *33.  In fact, plaintiff’s surgeon had been involved in a clinical trial on the issue.  Further, the additional information plaintiff argues should have been provided to the surgeon was not known at the time of plaintiff’s surgery.  “[M]anufacturers do not have a duty to warn of risk not yet known.”  Id. at *34-35.  Finally, plaintiff’s surgeon testified that he did not rely on materials from defendant in deciding to use the device.  Rather he relied on his experience and research.  So, even if a stronger warning had been included, the learned intermediary would not have seen or relied on them.  Id. at *36.

Plaintiff’s fraud claims suffered a similar fate.  Plaintiff alleged no statement or omission on which he personally relied, so any alleged misrepresentation must have been made to his physician.  To the extent those allegations mirror the failure to warn allegations, summary judgment was warranted.  Id. at *37-38.  Next plaintiff argued that defendant marketed a component of the device that did not have FDA clearance.  To the extent that claim is based on alleged misrepresentations made to the FDA during the regulatory process, it is preempted under BuckmanId. at *38.

Finally, plaintiff asserted punitive damages claim based on allegations of failure to warn and “actively misleading” physicians.  But, since summary judgment was granted on failure to warn and fraud, the punitive claim fell as well.  Id. at *41.

The game may not be over, but plaintiff is looking at a third and long with only one claim and shaky causation left.

Sooner or later we knew it would happen.  The law on general jurisdiction by consent has been developing very favorably – maybe even too favorably.  Since Daimler AG v. Bauman, 571 U. S. 117 (2014), almost every appellate decision (including every state court of last resort and federal circuit court) has rejected general jurisdiction by consent:  Lanham v. BNSF Railway Co., 939 N.W.2d 363, 371 (Neb. 2020); State ex rel. Cedar Crest Apartments, LLC v. Grate, 577 S.W.3d 490, 494 (Mo. 2019); DeLeon v. BNSF Railway Co., 426 P.3d 1, 4, 8-9 (Mont. 2018); Aspen American Insurance Co. v. Interstate Warehousing, Inc., 90 N.E.3d 440, 447-48 (Ill. 2017); State ex. rel. Norfolk Southern Railway Co. v. Dolan, 512 S.W.3d 41, 47 (Mo. 2017); Figueroa v. BNSF Railway Co., 390 P.3d 1019, 1021-22 (Or. 2017); Segregated Account of Ambac Assurance Corp. v. Countrywide Home Loans, 898 N.W.2d 70, 81-82 (Wis. 2017); Bristol-Myers Squibb Co. v. Superior Court, 377 P.3d 874, 884 (Cal. 2016), reversed on other grounds, 137 S.Ct. 1773 (2017); Magill v. Ford Motor Co., 379 P.3d 1033, 1038 (Colo. 2016); Genuine Parts Co. v. Cepec, 137 A.3d 123, 127-28 (Del. 2016); Chufen Chen v. Dunkin’ Brands, Inc., 954 F.3d 492, 499 (2d Cir. 2020) (applying New York law); Fidrych v. Marriott International, Inc., 952 F.3d 124, 137 (4th Cir. 2020) (applying South Carolina law); Waite v. All Acquisition Corp., 901 F.3d 1307, 1319 & n.5 (11th Cir. 2018) (applying Florida law); Brown v. Lockheed-Martin Corp., 814 F.3d 619, 640 (2d Cir. 2016) (applying Connecticut law); Aybar v. Goodyear Tire & Rubber Co., 106 N.Y.S.3d 361, 362 (N.Y.A.D. 2019); Fekah v. Baker Hughes, Inc., 110 N.Y.S.3d 1, 2 (N.Y.A.D. 2019); Best v. Guthrie Medical Group., P.C., 107 N.Y.S.3d 258, 260 (N.Y.A.D. 2019); Aybar v. Aybar, 93 N.Y.S.3d 159, 166 (N.Y.A.D. 2019), app. granted, 139 N.E.3d 391 (N.Y. 2019); Seeley v. Caesars Entertainment Corp., 206 A.3d 1129, 1133 & n.9 (Pa. Super. 2019); Wal-Mart Stores, Inc. v. Lemaire, 395 P.3d 1116, 1120 (Ariz. App. 2017); Dutch Run Mays Draft, LLC v. Wolf Block LLP, 164 A.3d 435, 444 (N.J. App. Div. 2017); Magwitch, LLC v. Pusser’s West Indies, Ltd., 200 So.3d 216, 218 (Fla. App. 2016).  Federal district courts in over 20 additional jurisdictions have agreed.  See the Blog’s Post-BMS Personal Jurisdiction Cheat Sheet (search for “register”).

On the other side, not so much, just Rodriguez v. Ford Motor Co., 458 P.3d 569, 575-78 (N.M. App. 2018), cert. granted, No. S-1-SC-37491 (N.M. April 8, 2019), and Webb-Benjamin, LLC v. International Rug Group, LLC, 192 A.3d 1133, 1137-38 (Pa. Super. 2018), and a smattering of district courts, mostly in Pennsylvania.

All this uniformity meant that no split in authority had developed, either between state high courts or among federal circuit courts (or both), such that an appeal to the United States Supreme Court of the issue would have a decent likelihood of success.

Until now.  We thought that Pennsylvania, with its pro-plaintiff supreme court, “deep end” jurisdictional rulings on other issues, split appellate authority, and unusual Long Arm statute (discussed here), was the most likely candidate to break the string and to create a certiorari-worthy precedential split.

Turns out we were wrong.

On the same day that the general jurisdiction by consent issue was argued to the Pennsylvania Supreme Court, the Georgia Supreme Court created a state high court split in Cooper Tire & Rubber Co. v. McCall, ___ S.E.2d ___, 2021 Ga. Lexis 626 (Ga. Sept. 21, 2021) (“McCall”).  However, the Georgia court did so reluctantly – essentially anticipating that the United States Supreme Court would take the case.  Moreover, the ruling was driven by a longstanding problem with the Georgia Long Arm statute.

The facts in McCall are relatively typical of this sort of case.  A Florida litigation tourist, claiming injury from an accident that occurred in Florida, sued the defendant, a nation-wide corporation, in Georgia.  There was nothing particularly special about Georgia in the defendant’s operations – it was neither the defendant’s principal place of business nor its state of incorporation.  2021 Ga. Lexis 626, at *2-3.

The Georgia Long Arm statute permitted “personal jurisdiction over any nonresident . . . in the same manner as if he or she were a resident of this state” with respect to certain “enumerated acts”:  “business” in Georgia, a “tortious act or omission” in Georgia or causes “tortious injury” in Georgia, if the defendant “regularly does” business or “derives substantial revenue from goods” in Georgia.”  Ga. Code §9-10-91.  Oddly, however, the statute defined “nonresident” as excluding corporations that had registered to do business in Georgia.

the term “nonresident” includes . . . a corporation which is not organized or existing under the laws of this state and is not authorized to do or transact business in this state

Ga. Code §9-10-90 (emphasis added) (quoted in McCall, 2021 Ga. Lexis 626, at *13).

That definitional quirk caused problems, since Ga. Code §9-10-91 is considered to be a definition of specific, rather than general, personal jurisdiction.  McCall, 2021 Ga. Lexis 626, at *13.  With registration to do business statutorily excluded as a basis for specific jurisdiction, unless it formed a basis for general jurisdiction, the Georgia Long Arm statute provided no basis at all for the exercise of personal jurisdiction over registered foreign corporations.  In a pre-Bauman decision, Allstate Insurance Co. v. Klein, 422 S.E.2d 863 (Ga. 1992) (“Klein”), the court confronted this drafting mistake, and rather than tell the legislature to fix it, it opted to subject registered foreign corporations to general personal jurisdiction by negative implication, considering them to be state “residents.”

[A] corporation which is “authorized to do or transact business in this state at the time a claim” arises is a “resident” for purposes of personal jurisdiction over that corporation in an action filed in the courts of this state.  As a resident, such a foreign corporation may sue or be sued to the same extent as a domestic corporation.

Klein, 422 S.E.2d at 865.  Klein was a very short opinion, and neither side raised a constitutional issue.  Id. n.3.  McCall conceded that Klein’s “inverse implication” creating general jurisdiction by registration “may not have been well-explained,” but it was also “not clearly wrong under the [pre-Bauman] governing case law at the time.  Id. at *26.

Thus, hanging over the McCall decision, and mentioned several times, was the Georgia Long Arm statute’s poor draftsmanship:

[H]ad the Court [in Klein] reached a different conclusion, a jurisdictional gap would have emerged whereby a registered out-of-state corporation would apparently not have been subject to any jurisdiction in Georgia − specific or general.

McCall, 2021 Ga. Lexis 626, at *26; accord id. at *27, 28.

The United States Supreme Court’s intervening constitutional decisions, however, had limited general personal jurisdiction in ways that the Georgia court candidly (and repeatedly) admitted were “in tension” with the holding in KleinMcCall, 2021 Ga. Lexis 626, at *1, 3, 29.  McCall quoted the Supreme Court’s most recent statement of general jurisdiction:

General jurisdiction, as its name implies, extends to any and all claims brought against a defendant.  Those claims need not relate to the forum State or the defendant’s activity there; they may concern events and conduct anywhere in the world.  But that breadth imposes a correlative limit:  Only a select set of affiliations with a forum will expose a defendant to such sweeping jurisdiction.  In what we have called the “paradigm” case, an individual is subject to general jurisdiction in her place of domicile.  And the equivalent forums for a corporation are its place of incorporation and principal place of business.

Id. at *10 (quoting Motor Co. v. Montana Eighth Judicial Dist. Court, 141 S. Ct. 1017, 1024 (2020)).  Other decisions that McCall acknowledged as applying this limited scope to general jurisdiction are:  Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), BNSF Railway Co. v. Tyrrell, 137 S. Ct. 1549 (2017), Daimler AG v. Bauman, 571 U.S. 117 (2014), and Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011).  McCall, 2021 Ga. Lexis 626, at *9-10.

To avoid a result that would resurrect the “jurisdictional gap” that it had avoided in Klein, the Georgia Supreme Court in McCall relied on the century-old, Pennoyer-era decision, Pennsylvania Fire Insurance Co. v. Gold Issue Mining & Milling Co., 243 U.S. 93 (1917), which allowed general jurisdiction to be based on “consent” created by a foreign corporation’s registration to do business.  McCall justified doing so because Pennsylvania Fire was a “decision that the Supreme Court has not overruled.”  2021 Ga. Lexis 626, at *1; see id. at *9, 19.  “Unless and until the United States Supreme Court overrules Pennsylvania Fire, that federal due process precedent remains binding on this Court and lower federal courts.”  Id. at *23-24.

We don’t think that’s right.  A case that McCall doesn’t cite, Shaffer v. Heitner, 433 U.S. 186 (1977), abandoned “the fiction[] of implied consent to service on the part of a foreign corporation” in favor of “ascertain[ing] what dealings make it just to subject a foreign corporation to local suit.”  Id. at 202-03.  Shaffer then expressly “overruled” all earlier decisions “inconsistent” with current Due Process standards.

It would not be fruitful for us to re-examine the facts of cases decided on the rationales of Pennoyer and [another century-old case] to determine whether jurisdiction might have been sustained under the standard we adopt today.  To the extent that prior decisions are inconsistent with this standard, they are overruled.

433 U.S. at 212 n.39 (emphasis added).  In a subsequent case, the Supreme Court again “cast aside” the registration theory of “consent” to general jurisdiction as “purely fictional”:

We initially upheld these [corporate registration] laws . . . on grounds that they complied with Pennoyer’s rigid requirement of either “consent,” or “presence.”  As many observed, however, the consent and presence were purely fictional.  Our opinion in International Shoe cast those fictions aside. . . .

Burnham v. Superior Court, 495 U.S. 604, 617-18 (1990) (citations omitted).

The “tension” that McCall repeatedly acknowledged between Pennsylvania Fire and “the trajectory of recent United States Supreme Court decisions,” 2021 Ga. Lexis 626, at *3, thus puts Pennsylvania Fire squarely within the Shaffer “to the extent” of “inconsisten[cy]” overruling footnote.

The tenor of the McCall decision was often apologetic – seemingly expecting the defendant to take the matter to the Supreme Court and get Pennsylvania Fire specifically overruled by name.  McCall asserted that, because Pennsylvania Fire survives, “we are not required to overrule Klein as a matter of binding federal constitutional law.”  2021 Ga. Lexis 626, at *1.

[A]lthough Klein’s general-jurisdiction holding is in tension with the trajectory of recent United States Supreme Court decisions addressing a state’s authority to exercise general personal jurisdiction over corporations, Klein cannot be overruled on federal constitutional grounds [because of Pennsylvania Fire]

Id. at *3-4.  McCall also conceded that the Georgia Long Arm statute “does not expressly notify out-of-state corporations that obtaining authorization to transact business in this State and maintaining a registered office or registered agent in this State subjects them to general jurisdiction.”  Id. at 23.  (McCall claimed that Klein provides such notice, id., although the word “general” does not even appear in the Klein opinion.)  Finally, McCall “acknowledge[d] that some other courts have held to the contrary.”  Id. at *21.

A lot of courts, actually − as we discussed at the beginning of this post the precedent that rejects general jurisdiction by consent.  As precedential support for the contrary position McCall cited:  Three early post-Bauman federal district court cases decided between 2015 and 2017, the New Mexico case we cited above, misattributed to the New Mexico Supreme Court, and a case that does not exist, “Weinstein v. Kmart Corp., 99 A3d 997, 997 (N.Y. 2012).”  2021 Ga. Lexis 626, at *21.

Umm . . ., New York Court of Appeals cases are not even in the Atlantic Reporter.  After a bit of digging, we found Weinstein v. Kmart Corp., 952 N.Y.S.2d 459 (N.Y.A.D. 2012) – a pre-Bauman intermediate appellate case with all of one substantive paragraph.  As our introductory caselaw discussion indicates, four more recent New York Appellate Division cases, as well as the Second Circuit applying New York law, have rejected general jurisdiction by consent in reliance on United States Supreme Court’s more recent precedent.

In sum, it appears to us that not even the Georgia Supreme Court itself was comfortable with what it did.  It did so because the state’s Long Arm statute, as written, would lead to an absurd (McCall calls it “perverse”) result if the court had followed the last decade of United States Supreme Court personal jurisdiction precedent:

[I]f we were to overrule Klein’s general-jurisdiction holding, these corporations would not be subject to general jurisdiction in this State, either.  This outcome would allow out-of-state corporations to insulate themselves from personal jurisdiction in Georgia simply by obtaining the requisite certificate of authority and registering to do business here, thereby effectively immunizing themselves from suit for any cause whatsoever.

2021 Ga. Lexis 626, at *28-29 (emphasis original).  The McCall court even advised the legislature that it should fix the statute:

[W]e note that the tension between Klein and recent United States Supreme Court precedent remains, and Klein’s general-jurisdiction holding may be undermined if the Supreme Court ever reconsiders and overrules Pennsylvania Fire.  For these reasons, the General Assembly could preemptively obviate that risk by modifying the governing statutes to enable Georgia courts to exercise specific personal jurisdiction over out-of-state corporations . . . [by] tailor[ing] this State’s jurisdictional scheme within constitutional limits.

Id. at *29.

We hope that the defendant in McCall does what that court expected it would do – take the matter to the United States Supreme Court and get the anachronistic Pennsylvania Fire decision overruled by name.  That would save those of us in Pennsylvania the trouble.

A recent order in the Xarelto MDL caught our attention because it is an example of something we see more and more:  A plaintiff in multidistrict litigation who neither accepts a settlement program worked out in the MDL nor is prepared to proceed with his or her claims once the chance to settle has passed.  So which will it be?  Take the defendants’ money or take your chances going it alone?

The plaintiff in In re Xarelto Rivaroxaban Products Liability Litigation, No. 17-5372, 2021 U.S. Dist. LEXIS 176170 (E.D. La. Sept. 15, 2021), chose his litigation strategy poorly.  The plaintiff’s decedent in that case used the defendant’s anticoagulation medicine under the direction of his cardiologist to reduce the risk of stroke and embolism.  Id. at *1.  He later stopped taking the drug seven days before a surgical procedure, again under his doctor’s orders, but sadly suffered uncontrollable bleeding during surgery and died.  Id.

At its peak, the Xarelto MDL included more than 30,000 individual cases, and more than 99 percent of them were resolved by an opt-in settlement program.  Id. at *4.  We have no information on the terms of the settlement program or how generous they were.  But, with a take rate exceeding 99 percent, we can commend both sides for coming to terms acceptable to the defendants and all but less than one percent of the plaintiffs.

The flip side, however, is that the less-than-one-percent had to prove their cases.  This plaintiff and her lawyers couldn’t do it.  They had no expert on causation.  They served one expert report, but did not provide all the materials required by the applicable case management order, and ultimately withdrew that expert.  Id. at *21.  Then, in opposing summary judgment, they submitted (late) an affidavit from the decedent’s surgeon stating that the excessive bleeding was caused by the use of the product and that if the product’s label had warned him of the risk of bleeding “he would have changed his decision on [the decedent’s] surgery.”  Id. at *6.

The affidavit, however, was a sham.  The surgeon later testified that the plaintiffs’ attorneys drafted the declaration (although he did sign it) and that he never read the product label until his deposition.  Id. at *7.  He also testified that he was unwilling to opine on whether the product could have caused the decedent’s death and that he did not know if there was any Xarelto in the decedent’s system during surgery.  Id. at *7-*8.

In other words, his sworn deposition testimony repudiated his affidavit, so the district court disregarded it:

Having reviewed [the surgeon’s] affidavit and deposition transcript, the Court finds that the affidavit is not competent summary judgment evidence.  The sham affidavit doctrine “prevents a party who has been deposed from introducing an affidavit that contradicts that person’s deposition testimony without explanation.”  Inconsistencies abound between [the surgeon’s] affidavit and his deposition testimony just three months later. . . .  In view of these unexplained inconsistencies, the Court need not consider the affidavit for summary judgment purposes.”

Id. at *19-*20 (citations omitted).  We call this the sham affidavit rule applied in reverse.  We have long understood that a party cannot raise a triable issue of fact by filing an affidavit contradicting his or her prior deposition admissions.  (See some of our prior commentary on sham affidavits here and here.)  In that event, the later affidavit is disregarded as a sham.  Here, we have the opposite.  The affidavit came first, and it was astute defense counsel and an honest live witness who completely obliterated it.  A sham flowing the other way.

That left the plaintiff again without a causation expert, so she requested leave to disclose yet a third expert.  But that expert’s report did not meet the requirements of Rule 26, and it did not proffer opinions sufficient to defeat summary judgment in any event.  The district court denied leave.  Id. at *21-*23.  And, the decedent’s other treaters could not fill the gap, as they confirmed that Xarelto would not have been in the decedent’s system a week after discontinuing use.  Id. at *17-*18.  The district court granted summary judgment on medical causation.

This ruling demonstrates the value of deposing affiants like the decedent’s surgeon here, and if that were the only takeaway from this order we would be satisfied.  However, in addition to medical causation, the district court ruled that the plaintiff’s warnings claims failed, too.  Applying Louisiana’s learned intermediary rule, the district court ruled that a drug manufacturer’s duty to warn runs to the prescribing physician and stated that “the plaintiff must show that ‘a proper warning would have changed the decision of the treating physician; but for the inadequate warning, the treating physician would not have used or prescribed the product.’”  Id. at *12-*13 (citations omitted).

The decedent’s prescribing physician “unequivocally testified” that the Xarelto label adequately warned him of the risk of bleeding and that it provided him with the information necessary to make an informed prescribing decision.  Id. at *13-*14.  He also said that Xarelto was the preferred medicine for the decedent and “I would still feel that way.”  Id. at *14.  The defendants therefore met their duty to warn.  Id. at *15.  Notably, the plaintiff’s third proposed expert purported to opine that the defendants failed adequately to warn the decedent of an increased risk, but that made no difference either because the duty to warn runs to the treating physician—the learned intermediary—not directly to the patient.  Id. at *22-*23.

The plaintiff’s design and manufacturing claims failed for lack of evidence too, but the main takeaway here is twofold.  First, if this plaintiff turned down an inventory settlement despite having failed to marshal evidence to support her case, imagine how many plaintiffs received settlement money despite being in similarly unsupported positions.  Such thoughts make us double down on our reservations about multidistrict litigation and its potential for harboring claims with no arguable merit.  Second, look out for affidavits that are too bad to be true.  They may not be.

Today we discuss a putative class action in which the named plaintiffs are a registered nurse who refuses to take a basic precaution to protect her vulnerable patients and a mother who is more interested in displaying her livestock than protecting her neighbors. Brought on behalf of all New Mexico residents who are equally selfish, the plaintiffs sought an injunction barring the state from enforcing a public health order that requires (with limited exceptions) all hospital, nursing-home, assisted-living-facility, adult-day-care, rehabilitation-facility, and prison workers, all employees of the governor’s office, and all who would enter the New Mexico State Fair grounds to be vaccinated against the SARS-CoV-2 virus, which causes COVID-19. The plaintiffs asserted various constitutional and statutory claims. In a thorough and trenchant decision, Valdez v. Grisham, — F. Supp. 3d —-, 2021 WL 4145746 (D.N.M. 2021), a federal district court rejected them all. That is consistent with long-standing precedent and other recent decisions—as we discussed here, here, and here.

The plaintiffs’ first claim was that requiring them to be vaccinated with “experimental” vaccines violated the FDCA. The claim was predicated on the fact that, at the time suit was filed, the three SARS-CoV-2 vaccines available in the United States—the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines—had not received full FDA approval and were instead being distributed and administered under Emergency Use Authorizations (EUAs). The plaintiffs claimed that requiring them to be vaccinated violated the terms of the vaccines’ EUAs, which require that those receiving each vaccine be informed of its “benefits and risks” and “of the option to accept or refuse” its administration. 2021 WL 4145746, at *4.

The court rejected the plaintiffs’ FDCA claim.

Implicitly responding to the plaintiffs’ assertion that the vaccines were “experimental,” the court recited at the outset both the extensive testing that each had undergone before the EUAs were granted, including “at least one well-designed Phase 3 clinical trial that demonstrate[d] the vaccine’s safety and efficacy in a clear and compelling manner,” and the fact that “[c]omprehensive data collected since the three vaccines received EUA status demonstrates that they are safe and highly effective in preventing infection and severe illness, and that serious adverse side effects from the vaccines are exceedingly rare.” 2021 WL 4145746, at *1. The court further observed that, “despite Plaintiffs’ protestation to the contrary, the FDA has now given its full approval—not just emergency use authorization—to the Pfizer vaccine” for administration to those 16 and older. Id. at *4. That did not moot the plaintiffs’ statutory claim, however, because the livestock-display-over-human-health plaintiff asserted the claim on behalf of not only herself but also her 11- and 12-year-old children, who were also keen to “show[] their animals” at the state fair. Id. at *2.

Addressing the merits of the plaintiffs’ FDCA claim, the court found that there were none. It explained that although the EUAs issued pursuant to the FDCA require “medical providers” administering the vaccines to inform would-be recipients of the risks associated with each vaccine and their right to refuse it, the EUAs do not prohibit the state from requiring individuals, duly informed by their medical providers, to be vaccinated. Id. at *4. In so holding, the court cited both Bridges v. Houston Methodist Hosp., 2021 WL 2399994, at *2 (S.D. Tex. 2021), which rejected a nearly-identical anti-vaxxer claim on the ground that the FDCA “neither expands nor restricts the responsibilities of private employers” and “does not confer a private opportunity to sue the government,” and a recent Department of Justice Office of Legal Counsel memorandum opinion concluding that the FDCA’s informed-consent provision “specifies only that certain information be provided to potential vaccine recipients and does not prohibit entities from imposing vaccination requirements.”

Having dispensed with their statutory claim, the court proceeded to dispense with the plaintiffs’ constitutional claims—brought under the Due Process, Equal Protection, and Contract Clauses.

Asserting a violation of their right to substantive due process, the plaintiffs alleged that they “‘have [constitutionally] protected liberty interests’ ‘in their right to live without governmental interference,’ their right ‘to bodily integrity,’ their right ‘to raise their children as they see fit,’ and their right ‘to engage in their chosen professions,’ and that because the state’s public health order is ‘not narrowly tailored,’ it violates these substantive due process rights.” 2021 WL 4145746, at *5.

Relying on well-established constitutional precedent, the court explained that a two-part analytic framework applies when a legislative enactment or executive action is challenged on substantive due-process grounds. The first step is to identify the “fundamental liberty interest” purportedly at issue. The second step is to determine whether that interest “is ‘deeply rooted in this Nation’s history and tradition’ and ‘implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if they were sacrificed.’” 2021 WL 4145746, at *5 (indirectly quoting Washington v. Glucksberg, 521 U.S. 702, 720–21 (1997)). If the asserted liberty interest meets that standard, then the government may not infringe it “‘unless the infringement is narrowly tailored to serve a compelling state interest.’” Id. (quoting Glucksberg, 521 U.S. at 721). If, by contrast, the legislative enactment or executive action “does not implicate a fundamental right,” the action is permissible if it “bear[s] a rational relationship to a legitimate government interest.” Id. (quotation marks omitted).

The court found that the plaintiffs did “not explain how the rights allegedly violated by the [public health order] are fundamental.” 2021 WL 4145746, at *5. “[I]ndeed nowhere,” said the court, did the plaintiffs “address how the right to work in a hospital or attend the State Fair, unvaccinated and during a pandemic, is ‘deeply rooted in this Nation’s history and tradition.’” Id.

In their request for preliminary relief, the plaintiffs relied on “the right to ‘engage in their chosen profession.’” 2021 WL 4145746, at *5. That, however, was no help to them, the court held, because “the Tenth Circuit”—the circuit within which the court sits—”has unequivocally held that the ‘right to practice in [one’s] chosen profession … does not invoke heightened scrutiny.’” Id. (quoting Guttman v. Khalsa, 669 F.3d 1101, 1118 (10th Cir. 2012)). Thus, said the court, “while Plaintiffs may ‘have a right to engage in their chosen professions,’ governmental infringement on this right will be “‘presumed to be valid’” so long as it is “‘rationally related to a legitimate state interest.”’” Id. (quoting Klaassen v. Trustees of Indiana Univ., 2021 WL 3073926, at *17 (N.D. Ind. 2021), in turn quoting City of Cleburne v. Cleburne Living Ctr., 473 U.S. 432, 440 (1985)).

Moreover, said the court, “federal courts have consistently held that vaccine mandates do not implicate a fundamental right and that rational basis review therefore applies in determining the constitutionality of such mandates.” 2021 WL 4145746, at *5. Applying that standard, the court rejected the plaintiffs’ substantive due-process claim, concluding that “[t]he vaccination requirements set forth in the [New Mexico public health order], … grounded in medicine and science, are rationally related to [the state’s] legitimate purpose of protecting our community ‘against an epidemic of disease [that] threatens the safety of its members.’” Id. at *8 (quoting Jacobson v. Massachusetts, 197 U.S. 11, 27 (1905)).

As Bexis did last month, the Valdez court explained that “[w]ith its decision in Jacobson”—which upheld “a Cambridge, Massachusetts regulation that required all adult inhabitants of that city, without exception, to be vaccinated against smallpox”—“the Supreme Court ‘settled that it is within the police power of a state to provide for compulsory vaccination.’” 2021 WL 4145746, at *6–7 (quoting Zucht v. King, 260 U.S. 174, 176 (1922)).

All that is necessary for state action to survive the “rational basis test” is that it bear “a rational relationship to a legitimate government interest.” Glucksberg, 521 U.S. at 721. The Valdez court found that New Mexico’s vaccination requirements did more than that, concluding that “[t]he governmental purpose of stemming the spread of COVID-19, especially in the wake of the Delta variant, is not only legitimate, but is unquestionably a compelling interest.” 2021 WL 4145746, at *7 (quotation marks omitted).

Having rejected plaintiffs’ substantive-due-process claim on the ground that that the New Mexico public health order requiring certain people to be vaccinated against SARS-CoV-2 “meets the rational basis test” (2021 WL 4145746, at *8), the Valdez court quickly disposed of the plaintiffs’ remaining constitutional claims. It concluded that the plaintiffs’ equal-protection, procedural-due-process, and impairment-of-contract claims were also subject to rational-basis review and that they therefore failed for the same reasons as the plaintiffs’ substantive-due-process claim. Id. at *9–11.

Finding that plaintiffs were unlikely to prevail on the merits of their claims, and that the remaining equitable factors likewise cut squarely against them, the court denied the preliminary injunction that the plaintiffs requested.

Onward to full vaccination.

Get a group of experienced lawyers together and it won’t be long before there is a one-upsmanship game of Crazy-Things-Judges-Have-Done. A learned and revered colleague tells the story of how he went to argue before a law and motion judge many years ago and low comedy ensued. Being a diligent sort of fellow, said learned colleague arrived at the courtroom early. His motion was far down the docket so he sat and watched other arguments. He figured he might learn something about this judge’s methods. He did learn something. Maybe he learned the ultimate something. It was not something expected.

He perked up upon hearing that the motion immediately before his involved the same legal issue and very similar facts. What good luck! Even better, the judge ruled exactly the way our friend wanted for his case. As you can imagine, our friend confidently planted himself in front of the lectern when it was his turn and said, “Your Honor, my motion will be very easy for you to decide, because it is precisely the same fact pattern you confronted a mere two minutes ago, it implicates precisely the same statute, and it warrants precisely the same outcome.” He grinned when he said this. That grin soon disappeared.

The judge proceeded to ask impertinent questions, voiced bizarre policy concerns, induced the opposing side to make arguments nowhere in the briefs, and then announced he was going to rule against our befuddled friend. Before packing up his brief bag in disgust, our friend could not help himself and voiced frustration to His Honor: “Judge, I simply cannot understand how I came in here and saw you rule my way in a case on all fours with mine, and yet you went against me. What ever happened to precedent?” The judge showed no annoyance. Rather, he beamed with beneficence, wearing a smile that seemed to acknowledge the difficulties in finding fairness in a world full of indignities, shook his head, and said, “Ah ah ah: fifty-fifty.”

Rough justice, indeed. It is one thing to face a judge who reliably rules pro-defense or pro-plaintiff. You get what you expect, be it a jolly or awful moment. It is quite another to face a judge who is visibly aiming for fairness, but whose idea of fairness is little more than splitting the difference, spinning a roulette wheel, or, as in our friend’s experience, alternating rulings — “fifty-fifty.” One almost prefers the punch in the nose from a hostile judge to being tripped up by a clumsy one. Note that we said “almost.”

While looking through Daubert decisions, we tripped over a case that is now over a half a year old. The case is In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litigation, 2021 WL 781682 (D. Md. March 1, 2021). The defendant moved to exclude various opinions offered by plaintiff expert opinions. The main issues were expert qualifications and … preemption. Right away, that seems a bit weird. Usually, the Daubert issues are qualification, reliability, and fit. But we‘ll never turn down a dinner date when preemption is on the menu. So let’s dig in, shall we?

Then again, maybe this case won’t be so appetizing. It begins with the court fretting over “the difficulty of drawing precise lines that anticipate every iteration of an opinion that may be offered in support of a specific claim that itself is yet to to be precisely defined in the context of an individual case.” That is the sound of reluctance, not decisiveness. That is something we often hear from judges who deny Daubert challenges or motions in limine without prejudice. They’d rather rule in real time at trial. You know – after the plaintiff’s witness has already waved the bloody stump or tossed the skunk into the jury box. (That “yet to be precisely defined” bit also sounds like a case that maybe does not pass muster under the pleading requirements of Twombly and Iqbal.)

Then the court tells us that Rule 702 “was intended to liberalize the introduction of relevant expert evidence.” Ouch. (Our prescription for deadening the pain of this malady is a dose of Bexis’s write-up on the proposed revisions to Rule 702. Find it here.) To be fair, the court was quoting from a Fourth Circuit case, but that quotation seems to wish away Daubert, reliability, and judicial gate-keeping. Then we get a list of Daubert factors, but also an admonition that the list is not a checklist. Get ready for loosey-goosey.

There is something in the Smith & Nephew opinion for everyone. That is true for preemption. The court held that several of the plaintiffs’ claims were preempted: strict liability, duty to change the label, duty to warn patients and doctors, liability for claiming the product was safe, and liability for representations the FDA required. But the court held that other claims, “to the extent they parallel federal obligations, are not necessarily preempted.” The plaintiffs focused on conditions imposed as part of the FDA’s approval of the hip implant system, including implementation of a surgeon training program and submissions of analyses of adverse events and complaints.

The latter seems in obvious tension with Buckman preemption of fraud-on-the-FDA claims. How did the Smith & Nephew court resolve this tension? The court excluded anything related to the PMA approval process, but did not exclude any expert opinions that the defendant failed to make adequate disclosures in its required annual reports after receiving premarket approval. To our defense hack eyes, all that stuff is subject to preemption, be it express (statutory) preemption, implied preemption, or Buckman preemption.

Similarly, the court held that a “claim which challenges a representation the FDA blessed in the approval process is preempted, while a claim challenging a warranty above and beyond any guarantee that was explicitly or implicitly approved by the FDA is not preempted.” The court also excluded testimony relating to Dear Doctor letters and other communications to the medical community or patients, but reasoned that testimony opining that the defendant “had a duty under the PMA or another federal requirement to disclose certain information to the FDA directly could still be relevant to a parallel state law failure to warn claim … so long as that claim can be proved based on a violation of a condition imposed by the FDA.” That all feels a bit fifty-fifty-ish, but the court clamped down on the plaintiffs’ claim that the company had a duty to modify its training program. The court also excluded any expert opinions that the defendant had a duty to withdraw its products. Only the FDA has authority to withdraw approval from a device.

The plaintiffs offered opinions from their experts regarding the duties of a reasonable manufacturer and whether the product was unreasonably dangerous. The court held that to the extent “any expert testimony seeks to rely exclusively on state law duties that are not pinned to federal requirements, they are irrelevant to the remaining claims in this case.” But one expert asserted that there were violations of a federal regulation or condition of approval, and the court refused to exclude that opinion. Expect plaintiff experts to drive a big-rig, tractor trailer through that hole, whether or not they have a commercial driver’s license or any similar driving expertise.

That brings us to the court’s discussion of expert qualifications. It is a dismal discussion. Most gaps or shortcomings in expertise went to weight, not admissibility, were fodder for cross-examination, etc. One expert was permitted to opine whether a surgeon training program was adequate from a clinical perspective, but could not opine as to whether it satisfied FDA regulatory requirements.

The court imposed some limitations on speculative testimony, historical-factual narratives, and legal conclusions (“except in a case involving a specialized industry where such a conclusion may be helpful to the trier of fact” – excuse us while we groan at another Mack truck-sized hole).

What do we think of the Smith & Nephew court’s rulings on the proffered expert testimony? Fittingly, perhaps, we are fifty-fifty.

We looked back over the blog and it’s been over one year since we posted on snap removal.  Last spring and summer, we reported on new pre-service removals almost monthly.  So, we decided to poke around a bit and see if there was anything going on outside the drug and device law space.  We found Choi v. GM LLC, 2021 U.S. Dist. LEXIS 172291 (C.D. Cal. Sept. 9, 2021) and thought the court’s reasoning was worth bringing to our audience.

Plaintiffs filed suit in Los Angeles County Superior Court against GM and three local dealerships.  Three days later, before any defendant was served, GM removed the case to federal court.  It was undisputed that complete diversity existed between plaintiffs and defendants.  Id. at *4n1.  It was also undisputed that the local dealerships were forum defendants which means that the “local-defendant” limitation on removals applies – if a case is otherwise removable on the grounds of diversity, it “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.”  28 U.S.C. §1441(b)(2).

There are two schools of thought on the forum-defendant rule.  There is the view that one should read into the statute a requirement that at least one defendant be served or that plaintiff be given a reasonable opportunity to serve at least one defendant before a case can be successfully removed.  We’ll call that the plaintiff-school.  Or simply, wrong.

The alternative view is that the statute should be afforded its plain meaning.  Only if a local defendant is “properly joined and served” may an action not be removed.  We’ll call that the defendant-school.  Or simply, correct.

The court first looked to the Ninth Circuit.  It has not addressed the issue.  Plaintiffs, therefore argued that since the majority of courts in the Central District of California have opted to follow the plaintiff-school, so too should this court.  But defendants had Central District cases on their side as well.  The court determined it need not decide “on which side of the line this District comes down with mathematical precision.”  Id. at *7.  Instead, the court looked to the reasoning of the only three federal appellate courts to have decided the issue.  And all three applied the plain meaning of the statute.

We’ve posted about all three appellate decisions – the Third Circuit’s Encompass Ins. Co. v. Stone Mansion Restaurant Inc., 902 F.3d 147 (3d Cir. 2018); the Second Circuit’s Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019); and the Fifth Circuit’s Tex. Brine Co., LLC v. Am. Arbitration Ass’n. Inc., 955 F.3d 482 (5th Cir. 2020).   Plaintiff tried to argue that there are in fact four appellate decisions on snap removal citing the Eleventh Circuit’s opinion in Goodwin v. Reynolds, 757 F.3d 1216 (11th Cir. 2014).  But the issue decided by that case was whether the district court erred in allowing the plaintiff to voluntarily dismiss her suit without prejudice.  Id. at *9.  While the district court had also denied plaintiff’s motion to remand, that ruling was not appealed and was not before the court – a point the 11th Circuit repeatedly points out in the opinion.  While there is some language in the decision to suggest that the court found the pre-service removal to be a “technicality” or “gamesmanship,”

the appellate court did not effectively re-write Section 1441(b)(2) by ignoring the “properly joined and served” language (as Plaintiffs essentially as the Court to do here).

Id. at *10.

The Choi court’s view is that if Section 1441(b)(2) is going to be re-written, it needs to be by Congress.  Id. at *11.  Indeed, the plaintiffs’ bar took the issue to Congress in 2019.  And as we discussed in our post at that time, the real issue should have been litigation tourism.  If Congress is going to do anything, it should get rid of the archaic forum-defendant rule not pre-service removal.

Putting Congress aside, the court explained why not adhering to the plain language of the statue is problematic.  To the extent plaintiffs wanted the court to read into the statute a requirement that they be given a “reasonable” opportunity to serve the complaint before service, the court recognized that would cause more problems than it would solve.  What is a “reasonable” time to effectuate service?  What is to stop one court from deciding 24 hours is sufficient and another from finding a week is reasonable?  Plaintiffs encouraged the court to follow the district majority on this issue to promote predictability and consistency.  But introducing an undefined “reasonableness” standard into the rule would only lead to less, not more certainty.  Id.*13-14.  And, as for that district majority in the plaintiff-school, none of the Central District cases on which plaintiffs relied were decided after Encompass, Gibbons, or Tex. Brine.  Following the overwhelming appellate level support for pre-service removal, the Central District cases started joining the defendant-school; they just don’t outnumber the earlier cases yet.  Id. at *13n.6.

In sum, “[c]ertainty follows from application of the plain language of a statute, an approach that is in-line with the only federal courts of appeal to have directly-considered the question.”  And not through “inexact standards based upon words and/or principles that do not actually appear in the statute.” Id. at *14.