We’ve already commented about the broad scope of tort immunity conferred by the March, 2020 Notice of Declaration under the Public Readiness & Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §247d-6d.  That original immunity covered all aspects of government-related or sponsored production and use of anti-COVID countermeasures.  It was, as one of our colleagues put it, broad enough to cover a fight in the parking lot while waiting for drive-through COVID testing.

Well, COVID-19-related PREP Act tort immunity just got a whole lot bigger.

Yesterday, the Department of Health & Human Services (“HHS”) released a “Fourth Amendment” to the March Declaration, entitled innocuously enough, “Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 and Republication of the Declaration” (“Fourth Amendment”).  While we also looked for this in yesterday’s Federal Register, we didn’t find it.

In what appears to be HHS’s administrative response to the ongoing congressional deadlock over whether to create COVID-19 related immunity affecting the private sector, this Fourth Amendment undertakes to extend PREP Act immunity to a broad swath of purely private sector activities related to the administration, and in some cases the non-administration, of COVID counter measures.  The HHS summary states, among other things, that PREP Act immunity extends to:

  • “substantial federal legal and policy interests . . . [that require] a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.”
  • “situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration’s liability protections.”
  • “provide liability protections for, among other things, additional private-distribution channels”
  • “an additional category of Qualified Persons . . . [namely] healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.”

Fourth Amendment, Summary, at items c, f, g, h.

What does that mean?

As for what we do, litigation, to have a “uniform interpretation,” the Fourth Amendment expressly intends for there to be “an exclusive Federal cause of action”:

[T]here are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.  Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party’s exclusive remedy is an administrative remedy.

Fourth Amendment, at part XI (emphasis added).  Grable, as long-time blog readers know, is a Supreme Court decision finding federal subject matter jurisdiction over ostensibly state-law claims that “necessarily raise[]” “important” federal issues for which a federal forum was needed to “vindicate [federal] administrative action.”  514 U.S. at 314-15.  While Grable expected such situations to be “rare,” id. at 315, that is unlikely to be the case under the HHS Fourth Amendment.


Substantively, HHS has created an additional “pathway” for immunity that removes the prior prerequisite under the Declaration’s other Limitations on Distribution requiring that “covered persons” using on-label “Covered Countermeasures” being distributed under FDA auspices to combat COVID-19 have an agreement with the federal government.  The Fourth Amendment creates a “third distribution channel” allowing a Covered Person that manufactures, tests, develops, distributes, administers, or uses the Covered Countermeasure under FDA or NIOSH (for “respiratory devices”) auspices even though “there is no federal agreement or authorization.”  Fourth Amendment, at §VII.  A manufacturer, distributor, program planner, or qualified person that satisfies the other requirements of the PREP Act and prior HHS declarations, is immunized even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction.  Id.:

I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving:

  1. Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements;
  2. Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency; or
  3. Covered Countermeasures that are:
  4. licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom; or
  5. a respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom.

To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

Fourth Amendment, Additional Amendments at VII.  Thus PREP Act immunity now extends to entities, such as nursing homes or manufacturing plants, acting in a purely private capacity, as long as they “manufacture, test, develop, distribute, administer, or use” Covered Countermeasures.  This extension of PREP Act immunity to purely private activities, if not entirely mooting the current congressional stalemate, appears to eliminate a large portion of the liability situations Congres has been debating.

The Fourth Amendment also broadens the definition of a PREP Act “Covered Person” to include not only pharmacists administering COVID vaccines, but “any person authorized . . . to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures.”  Fourth Amendment, Additional Amendments at V.  “Authorized” is nowhere limited by any requirement that the Covered Person actually have prescribed, administered, etc. a Covered Countermeasure.  Telemedicine is also now explicitly within the scope of PREP Act immunity.  Id. at V(e).

Also, remember those PREP Act cases we discussed that distinguished between the administration and non-administration of Covered Countermeasures?  The Fourth Amendment also broadens immunity to include non-administration situations where there is a “limited” supply of such countermeasures:

Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to . . . the administration to . . . an individual” under 42 U.S.C. 247d-6d. . . .  Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act and this Declaration’s liability protections.

Fourth Amendment, Additional Amendments at IX.

Nor is PREP Act immunity limited to COVID-19 itself.  Part VIII of the Additional Amendments provides extends immunity to “other diseases, health conditions, or threats that may have been caused by COVID–19, . . . including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.”

The Fourth Declaration also extends the immunity for “an additional 12 months,” until October 1, 2024, and defines causation under the PREP Act’s compensation program (the “Countermeasures Injury Compensation Program” or CICP) to require “compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation.”  Fourth Amendment, Additional Amendments, at XII-XIV.

There are many details in the Fourth Amendment that we have left out or glossed over.  As the footnotes to the Fourth Amendment indicate, there are also advisory opinions and guidances in addition to the original Declaration and, now, four amendments.  We recommend that anyone interested in the matters discussed in this blogpost read the Fourth Amendment for themselves or discuss it with their lawyers.

Along with Shakespeare’s plays and painfully plodding Victorian novels, there is a good chance that your western high school (or perhaps college) education included at least a smattering of philosophy.  The line between political science and philosophy can be hard to draw—Kant, Hobbes, and Rousseau might be featured in classes under either heading, for instance—but more fundamental philosophical considerations seem to be resigned to the recesses of our brains by the time law school begins its takeover.  Once legal practice starts, forget about it.  Drafting legislation or regulation, or perhaps challenging them, may involve an amorphous thing called public policy, but that is not really philosophy.  While definitions vary, and the linguistics only sheds so much light, we can say that a question like “what is the difference between expanding a right and rejecting a proposed limit on a right” is a matter of philosophy.  We can also say that it is an important question to ask in the context of Erie restraint and one that more federal courts sitting in diversity should be asking.

Having followed the principles behind Erie restraint for some time and noted how often federal courts have extended existing state law past its reasonable limits when trying to get around preemption or some other hurdle to plaintiff recovery, especially in the MDL context, we think we know the “right” answer to the philosophical question posed above.

Some principles first.  Tort plaintiffs can recover only when they establish the elements for a cause of action recognized by applicable case law or statute.  Under the U.S. Constitution and basic federalism principles, states get to decide their own laws.  While there may be federal constitutional limits on state laws as written or applied, federal actors do not get to establish state law.  If a state court plaintiff brought suit based on a novel tort claim not established by state statute or controlling caselaw, then the state court, according state jurisprudence, state constitutional provisions, and perhaps other considerations, would get to decide if it could establish a new cause of action or just dismiss the suit for failure to state a claim upon which relief could be granted.  (Some might call the former route “judicial activism,” but an exposition of the line between legislative authority and common law is beyond the scope of this post.  The latter route, and the existence of Fed. R. Civ. P. 12(b)(6) and state equivalents, speak to the fact that some complaints include some wacky claims.  Outside of our area, pro se prisoner cases and post-election voter suppression cases may be good examples of such wackiness.)

The seminal decision authored by Judge Brandeis in Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938), recognizes that the role of federal court sitting in diversity is different.  The core, and oft-cited, holding is that, “[e]xcept in matters governed by the Federal Constitution or by Acts of Congress, the law to be applied in any case is the law of the State.”  Id. at 78.  The underlying reasoning, however, is rooted in federalism and has given risen to Erie restraint (or the Erie doctrine) over the last 82 years.  Many of our prior posts on this subject, go into detail (like here, here, and here), so we will be relatively brief in our recap and just focus on what the Supreme Court has said.  Erie said federal judges do not get to “brush[] aside the law of a state in conflict with their views” and “advance[e] the doctrine [the federal judge] thinks at the time should be the general law on a particular subject.”  Id.  Because states get to “define the nature and extent” of rights to recover relief, “[t]hat object would be thwarted if the federal courts were free to choose their own rules of decision whenever the highest court of the state has not spoken.”  West v. AT&T Co., 311 U.S. 223, 236 (1940).  “A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.”  Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 5 (1975).  Importantly, there is nothing in 28 U.S.C. § 1407, which authorizes MDLs, or in an controlling interpretation of that statute, that gives an MDL judge more license to create new state law that any other federal judge presiding over an individual diversity case.

So, back to our philosophical question.  If there is a plaintiff who seeks recovery for an undeniably novel claim—let’s say, “malicious staring” for a stranger “looking funny” at the plaintiff while he walked down the street—then it should be easy for the presiding federal judge to conclude that it is the plaintiff asking for the creation of a new state right not the defendant asking the judge to impose a new limit on a state right.  By contrast, there could be a situation where the defendant is clearly asking for the creation of a new state law limit or defense—like the recognized state claim of “malicious staring” cannot stand if the plaintiff was, as a matter of law, “funny looking.”  (We vaguely recall a pro se prisoner case against a prison guard along these lines from our days as a clerk, for what it is worth.)

A perhaps harder question might come from an MDL where plaintiffs are suing over a PMA device and trying to come up with a parallel claim to squirm through the narrow gap between express preemption and implied preemption.  Or maybe a plaintiff who claims injury from her use of a generic drug has sued both the manufacturer of the drug she took and the manufacturer of the drug with the NDA; she needs to come up with a non-preempted claim against the former and some claim against the latter that gets her past the traditional product liability hurdles she would not clear.  Assume in each case that the applicable states each have a fairly well-developed negligence law with older cases adopting the basic elements and more recent cases setting out requirements for cases against the manufacturers of prescription medical products, but that they have neither product liability statutes abrogating all common law nor high court cases ruling on the claims these plaintiffs need to assert to get have some chance of recovery.  Negligent failure to report adverse events to FDA?  Negligent failure of the generic manufacturer to ask the branded manufacturer to update its label?  Innovator liability?  When the viability of these claims get decided on a defendant’s motion to dismiss or motion for summary judgment, the posture is almost always rightly viewed as an attempt by the plaintiff to create or expand state rights not an attempt by the defendant to impose a new limit on an existing right.  This means that federal courts deciding these issues should use their Erie restraint as a brake on creating new state law rights.

Even skipping our many posts on federal courts deciding purported parallel claims or innovator liability, the philosophical underpinning should be pretty clear.  In these situations, the plaintiff needs the law to expand or he loses, whether because of preemption, lack of duty, lack of causation, or something else.  The defendant wins absent an expansion, so it is not seeking a new limit.  We think this is what was going on in In re Testosterone Replacement Therapy Prods. Liab. Litig., MDL No. 2545, Case No. 17 C 3775, 2020 WL 6487327, *1 (N.D. Ill. Nov. 4, 2020), where an MDL judge evaluated whether Florida law imposed a duty on a prescription drug manufacturer “to provide warnings in some manner apart from the product’s FDA-approved package insert.”  The basic facts are that the particular plaintiff (hereafter, Davis) was prescribed and used the drug entirely, but shortly, after the label had been changed to include a paragraph on the relevant risk specifically required by FDA.  Although the opinion never said this, this clearly meant that Davis could not assert the same failure to warn claim that other plaintiffs had asserted because it would probably be preempted under Albrecht if it did not fail for lack of proximate cause.  Also absent in the opinion was any mention of Erie.  The concept of restraint—but not the word—is introduced only in the penultimate paragraph in a way that gives away the result but also frames the philosophical issue about which we have blathered thus far:

For the foregoing reasons, the Court disagrees with Actavis that under Florida law, a prescription drug manufacturer has no duty to provide warnings in a manner apart from the FDA-approved package insert.  In reaching this result, the Court recognizes that it must take care not to expand Florida law “beyond the boundaries established” in the state’s jurisprudence.  King v. Damiron Corp., 113 F.3d 93, 97 (7th Cir. 1997) (internal quotation marks omitted); AbbVie Reply at 7 (quoting same).  Florida courts have not addressed the question Actavis presents, and there is ample support for the conclusion that Florida courts would reject Actavis’s narrow interpretation of the duty to warn. Therefore, the Court denies Actavis’s motion for summary judgment.

Id. at *10.

Yes, the court engaged in a lengthy exercise of attempting to ascertain existing Florida law on the duty of prescription drug manufacturers in relation to warnings.  Yes, upon determining that the particular issue had not been decided, the court looked at cases from other jurisdictions to try to predict what the Florida Supreme Court would do if it decided this issue.  And, yes, those are the basic steps a federal court is supposed to take in a situation like this, assuming it does not avail itself of the opportunity to certify a question to the Florida Supreme Court as happened in Lehman Brothers v. Schein, 416 U.S. 386 (1974), and many other cases.  However, we think the entire analysis was misguided because it was premised on the idea that the defendant wanted to impose a new limit on its duties under Florida law instead of the reality that plaintiff wanted to create a new duty for drug manufacturers under Florida law because he had no claim otherwise.

We could belabor this by walking through the court’s actual analysis, but it is not really necessary.  Like in the recently published Zitney decision from a Pennsylvania state court, which did not have Erie to restrain it, the proposition that a drug manufacturer with an adequate FDA-approved package insert has a dutyto provide warnings in some manner apart from the product’s FDA-approved package insert” is a minority position.  The majority position, intertwined with the learned intermediary doctrine, is that a plaintiff cannot win a failure to warn claim when the package insert is adequate.  Most jurisdictions to weigh in also recognize that a prescription within two months of FDA approval of the package insert will lead to preemption of any warnings claim—especially where, like Davis—the FDA had specified the language to be included about the risk at issue.  It should not be a matter for distinction that Zitney or Florida law cases like Metz and Guarino (discussed in Davis) involved generic drugs.  Id. at **5-6.  Like in those cases, the plaintiff in Davis needed to expand existing state law to create a new duty to allow him to offer a non-preempted warning claim against the defendant he chose to sue.  (It really seems that his issue about the dissemination of the approved label for the drug he took was with his pharmacy, but that would not have fit neatly within the MDL framework.)

In that context, the question is not whether the defendant had proven why Florida would not follow a few minority cases (often older and rejected by later cases).  Showing appropriate restraint, the prediction of a proposed expansion in Florida state law should draw on actual indications in Florida state court decisions to see if clear support for expansion exists.  When it does not, then the federal court should not “go there.”  We submit that Davis, like far too many MDL courts in the past, should not have predicted a clear expansion of state law duty by claiming it was rejecting an imposition of a new state law limit.  You do not have to take our word for it.  The Seventh Circuit decision on Erie restraint cited in Davis makes just this point:

We have counseled before that “federal courts sitting in diversity ought to be circumspect in expanding the law of a state beyond the boundaries established in the jurisprudence of the state.”  Dausch v. Rykse, 52 F.3d 1425, 1438 (7th Cir. 1994) (Ripple, J. concurring, joined by Coffey, J. concurring).  See also Twin Disc, Inc. v. Big Bud Tractor, Inc., 772 F.2d 1329, 1333 (7th Cir. 1985) (“Because we are unable to predict what the Wisconsin courts would do in such a case, and because of the substantial policy considerations involved, we hesitate to expand Wisconsin law to allow these tort claims in the absence of a more direct indication of intent by the state courts or Legislature.”); Torres v. Goodyear Tire Rubber Co., Inc., 857 F.2d 1293, 1296 (9th Cir. 1988) (“In this case, however, we hesitate prematurely to extend the law of products liability in the absence of an indication from the Arizona courts or the Arizona legislature that such an extension would be desirable.  We have limited discretion in a diversity case ‘to adopt untested legal theories brought under the rubric of state law.’”).

King, 113 F.3d at 97.  Expanding state law to allow new tort claims or adopted untested legal theories is for state legislatures and sometimes state courts, but not for federal courts, MDL or otherwise.


A little over a month ago, we blogged about the Pennsylvania Superior Court (the Commonwealth’s general intermediate appellate court deciding a test case, Zitney v. Wyeth LLC, 2020 WL 6129173 (Pa. Super. Oct. 19, 2020), that held, as a matter of first impression, that there was no separate duty for a prescription medical product manufacturer – after providing concededly adequate warnings with its product – to take the further step of repeating those warnings in a “Dear Healthcare Provider” (sometimes called “Dear Doctor”) letter addressed directly to the plaintiff’s prescribing physician.

At the time, we described Zitney as a “significant, albeit unpublished, decision.”  It seemed odd to us that, with Zitney having been pursued deliberately as a test case, that the result would be non-published, and thus non-precedential.  Evidently, that seemed odd to the prevailing defendants as well.  The Superior Court has now granted an application for publication (timely filed by the prevailing defendants), and we’re pleased to update our readers that Zitney is now a publish, fully precedential decision.  The new citation (the memorandum cited above and in our original post is now withdrawn) is:  Zitney v. Wyeth LLC, ___ A.3d ___, 2020 PA Super 278, 2020 Pa. Super. Lexis 954 (Pa. Super. Dec. 1, 2020).

As for the court’s reasoning in Zitney, the decision is substantively verbatim identical to what we described in our prior post.

Product liability plaintiffs sometimes sue every entity in the distribution chain. But in many jurisdictions under many circumstances, there is an out for nonmanufacturing defendants. That was the case in Martinez v. Medical Depot et al., 434 F. Supp. 3d 537 (S.D. Texas 2020). The plaintiff was injured when an armrest on his unmotorized wheelchair allegedly broke. The wheelchair was manufactured by one company, sold by another, and delivered by yet another. The retail and delivery companies moved for summary judgment.

The case was governed by the Texas Products Liability Act (TPLA). Under the TPLA, an “innocent seller” is a nonmanufacturing seller that is not liable unless the plaintiff can prove one of seven exceptions. Those exceptions relate to participation in design, modification, installation, or actively making representations about the product, or being the only avenue of relief because the manufacturer is broke, gone, or unavailable.

The plaintiff in Martinez could not make out any of the exceptions. The wheelchair was simply delivered in a box. There was no modification or installation. Nor was there any accompanying material representation. The plaintiff groused about a representation of a 300 pound weight limit. The plaintiff weighed only 160 pounds. But there was no showing that the weight representation was incorrect. In any event, the plaintiff admitted he ignored the written instructions because he was pretty sure he knew how to operate a nonmotorized wheelchair. That bit of honesty (who among us has not gleefully cast aside an instruction pamphlet?) meant that the retailer and delivery companies prevailed on summary judgment.

But the court did not stop there. Just in case there would be an appeal, the court also granted summary judgment on another ground: the plaintiff’s failure to designate an expert witness. The plaintiff’s theory was that the wheelchair armrest could not support his weight. The Martinez court held that this sort of product liability theory required expert testimony. The plaintiff argued that expert testimony was required for manufacturing defect claims, but not design defect. The Martinez court disagreed. It concluded that the cause of the wheelchair’s collapse was beyond a layman’s understanding. The plaintiff backed up his claim with flimsy, inconsistent ideas along with some broken parts. That simply wasn’t enough.

Over the last couple of weeks there have been several high-profile, politically-charged cases. What we’ve learned is that notions, speculations, and prejudices that might inspire deeply felt convictions in everyday life just might not be enough to pass muster in court.

And we are okay with that. In fact, we are grateful.

This post is from the non-Reed Smith side of the blog.

Talking about being “at home” has a new meaning this year and no doubt we all would really enjoy some changed scenery about now.  This blogger used the Thanksgiving holiday weekend to merr-ify her surroundings.  Allowing decorating for the holidays to spill over into “the office.”  There are bows and ribbons, a cheery snow globe, and maybe just a twinkling light or two (hundred).  That’s a positive.  On the negative side, we used to ship a lot of stuff to our office this time of year to keep it out of sight.  But deliveries to “the office” now land on the front porch.  Which also means, prying eyes (both young and old) have started to see those boxes and there really is no hiding them.  Various shapes and sizes.  Some light, some heavy.  There they sit, absolutely within reach but yet so unattainable.  It’s almost cruel.  It’s definitely a little funny.  Most of all it feels apropos for this year.  Where everything just feels a little bit out of reach.

Which is what the defendant was in Fernandez v. Abbott Labs, 2020 U.S. Dist. LEXIS 221565 (S.D. Fla. Nov. 24, 2020) – out of reach.  Plaintiff alleged she suffered an injury from two medical devices manufactured and sold by the defendant.  Both devices were designed, manufactured, and marketed by a separate entity that was acquired by the defendant in 2017.  Id. at *4. To establish personal jurisdiction under Florida’s long-arm statute, plaintiff would need to demonstrate that the defendant either “committed a tortious act within Florida or caused an injury to  her in Florida arising out of an act outside of the state.”  Id.  But plaintiff could not refute that the merger agreement between the predecessor and successor companies did not provide that defendant assumed any prior product liability.  Id.

So, plaintiff instead argued that the corporate acquisition falls into an exception to successor liability because defendant is a “mere continuation” of the prior company.  However, continuation does not turn on whether the business continues.  It depends entirely on corporate structure – a common identity of officers, directors, and stockholders.  Plaintiff offered no evidence as to the corporate structure of either company.  Therefore, because defendant did not manufacturer or sell the medical devices and did not assume liabilities of the entity that did, plaintiff cannot establish specific personal jurisdiction.  Or liability anywhere else for that matter.   The court did not reach the due process question because plaintiff failed to establish any act to confer jurisdiction under the long arm statute.

Plaintiff’s last grasp was to argue that the court could exercise general jurisdiction because the defendant conducts business in Florida.  Unlike most of us, defendant was able to argue it was not “at home.”  Abbott is an Illinois citizen and therefore, not at home in Florida.  Plaintiff did not counter defendant’s position with any “affirmative support” for her personal jurisdiction allegations.  She merely relied on the allegations of her complaint which is insufficient.  Id.  at *6-7.  No general jurisdiction either.   Case dismissed.

Perhaps the biggest conflict among the circuits in PMA preemption cases involves the extent to which plaintiffs can get away with pleading essentially nothing to support supposed “parallel” violation claims, on the one hand, or on the other must plead a particularized violation of an FDA regulation (usually a “Current Good Manufacturing Practice” or “CGMP”) and show that the claimed violation is plausibly linked to the injury the plaintiff claims.  The leading case for the anything goes position is Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (bashed here), which held:

Defendants’ proposed distinction between concrete, product-specific requirements and more general requirements would also leave injured patients without any remedy for a wide range of harmful violations of federal law.  The FDA regulations contain many requirements that are not concrete or product-specific, yet which are obviously vital to producing safe and effective medical devices.

Id. at 555.  See also Howard v. Sulzer Orthopedics, Inc., 382 F. Appx. 436, 441 (6th Cir. 2010).

More courts, thankfully, go the other way, with probably the leading case being Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. 2011):

[W]e must first consider whether [plaintiffs] have demonstrated that they have alleged a parallel claim.  Plaintiffs cannot simply incant the magic words “[defendants] violated FDA regulations” in order to avoid preemption.  Parallel claims must be specifically stated in the initial pleadings.  A plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue.  To properly allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that have been violated.

Id. at 1301 (citations and quotation marks omitted).  See also Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011); In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1211-12 (8th Cir. 2010); cf. Weber v. Allergan, Inc., 940 F.3d 1106, 1114 (9th Cir. 2019) (expressly avoiding this issue).

For a long time, the Third Circuit had not touched on that issue.  In the absence of definitive guidance, district courts in Third Circuit states had generally required specific pleading of parallel claims in accordance with how courts generally apply Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009) (collectively, “TwIqbal”).  “[I]nsofar as Plaintiffs attempt to use the GMPs as the basis for a parallel claim, courts have regularly found that general citations to the GMPs or federal regulations are not specific enough to sustain a parallel claim.”  Conley v. St. Jude Medical, LLC, ___ F. Supp.3d ___, 2020 WL 5087889, at *5 (M.D. Pa. Aug. 28, 2020).  Conley cited:  Walls v. Medtronic, Inc., 2019 WL 6839942, at *4 (E.D. Pa. Dec. 16, 2019) (“Plaintiffs have pled their claims in general terms, and they have not identified any violation of specific FDA regulations.”); Starks v. Coloplast Corp., 2014 WL 617130, at *5 (E.D. Pa. Feb. 18, 2014) (“broad references to federal regulations are insufficient” to state a parallel claim); and especially Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), which held:

Allowing a plaintiff to plead non-specific regulations as a basis for a parallel claim is inconsistent with the Supreme Court’s reasoning in Riegel [v. Medtronic, Inc., 552 U.S. 312 (2008)], as well as the pleading requirements articulated in [TwIqbal].  This Court requires a greater level of specificity in pleading a parallel claim, rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.

Id. at 495-96 (citations omitted).  See also Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *7 (W.D. Pa. Sept. 19, 2013) (“CGMPs do not provide such a fine level of detail concerning the manufacture [of a medical device], the manufacturer must establish its own specific quality control system for the medical devices it produces to ensure that they are safe and effective.”) (citations and quotation marks omitted).

About the same time Walls was decided, a footnote decision in Irizarry v. Abbott Laboratories, 2019 WL 5061127 (E.D. Pa. Oct. 8, 2019), likewise held that vague violation allegations failed to plead a viable “parallel” violation claim.

Here, the plaintiffs are unable to establish that the . . . device was manufactured in a manner that violated the PMA requirements.  Essentially, their allegations do not fit through the “narrow gap” necessary to avoid preemption.  The original complaint lacked any specific allegations of the way in which the device was manufactured that failed to comply with the PMA requirements.

Id. at *1 n.1.  Those plaintiffs appealed and not long ago the Third Circuit agreed with the district court:

In anticipation of [defendant’s] preemption defenses, [plaintiffs] attempted to plead only non-preempted claims, commonly referred to as “parallel” claims. . . .  [H]ere, in their complaint, [plaintiffs] do not set forth the premarket approval requirements for the . . . Device.  Without doing so, they do not provide any non-conclusory, non-speculative allegations to support a parallel claim.  Absent reference to actual premarket approval requirements, [plaintiffs] do not plausibly allege that [defendant] abridged a state-law duty that neither adds to nor differs from the federal premarket approval requirements.

Irizarry v. Abbott Laboratories, ___ F. Appx. ___, 2020 WL 6441117, at *1 (3d Cir. Nov. 3, 2020) (citations omitted).  Nor could that lack of specificity in plaintiffs’ pleadings be cured with an expert report, since an expert report is not a “written instrument” and thus “cannot be incorporated into the complaint for purposes of the plausibility analysis” under TwIqbalId. at *2.

New Jersey courts have reached the same conclusion.  Desai v. Sorin CRM USA, Inc., quoted and followed Gross:

Allowing a plaintiff to plead non-specific regulations as a basis for a parallel claim is inconsistent with the Supreme Court’s reasoning in Riegel, as well as the pleading requirements [under Rule 8].  This Court requires a greater level of specificity in pleading a parallel claim, rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.

2013 WL 163298, at *7 (D.N.J. Jan. 15, 2013).  “[A] plaintiff must successfully plead a claim before obtaining discovery, not the other way around.”  Becker v. Smith & Nephew, Inc., 2015 WL 4647982, at *3 (D.N.J. Aug. 5, 2015) (citations omitted).  See also Smith v. Depuy Orthopaedics, Inc., 2013 WL 1108555, at *12 (D.N.J. March 18, 2013) (“none of Plaintiff’s claims are parallel to federal requirements because none of the claims are adequately pled with the specificity required for parallel claims”), aff’d, 552 F. Appx. 192 (3d Cir. 2014) (dismissal without discovery not abuse of discretion); Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859, at *7 (D.N.J. Dec. 15, 2009) (complaint was “fatally conclusory and . . . does not connect the device implanted in the plaintiff with any of the allegations about noncompliance with FDA requirements”).

While anything could still happen – such as an outlier pro-plaintiff panel like In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), vacated, 139 S. Ct. 1668 (2019) − for the time being it appears that specificity is a firmly established requirement in the Third Circuit in “parallel claim” preemption cases.

As we mentioned, several of your Reed Smith bloggers are making plans to attend ACI’s annual Drug and Medical Device Litigation conference, as they celebrate the 25th anniversary of the event. We’re looking forward to great content and virtual networking opportunities – and maybe even the chance to catch up with some of our loyal readers at a virtual table or coffee station (phrases we didn’t imagine saying when the year began).

Since we’d like to see you at ACI, we wanted to share that the good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-710-710EX04 when you register. You’ll save 10 percent.

We look forward to seeing you!

This is the third consecutive week a case from Indiana has been in our sights. By and large, we have been impressed with the quality of the Indiana judiciary in both the state and federal courts. One hallmark of exemplary judging is the capacity to revisit rulings and change course when necessary. We clerked for a judge (William Norris on the Ninth Circuit) who was brilliant and hard-working and hardly ever made mistakes, but when he concluded he or his panel got something wrong, he stepped up immediately and fixed what needed fixing. As recent events have made crystal clear, judicial integrity is a bedrock of the republic.

Today’s case, In re Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Product Liability Litigation, 2020 WL 241097 (S.D. Indiana Jan. 6, 2020), shows a court realizing that a piece of evidence admitted after a close call was so abused and so consequential that a new trial was warranted.

First, have a few bites of background. (But not too much; you don’t want to spoil your appetite for tomorrow’s festivities.) The plaintiff claimed that an IVC filter’s defective design caused it to fracture within her, leading to follow-up operations, after which some pieces of the filter remained inside her. She brought the action in the Northern District of Georgia, but the case was scooped up by the Multi-District Litigation, and then was remanded to the Southern District of Indiana, where it went to trial. The jury returned a verdict for the plaintiff in the amount of $3 million. The defendant then filed post-trial motions for judgment as a matter of law (Fed. R. Civ. P. 50) and for a new trial (Fed. R. Civ. P. 59).

The Rule 50 motion for judgment as a matter of law did not succeed. Such motions usually do not. They face a tough standard. A court may enter judgment against a party who has been fully heard on an issue during a jury trial if a reasonable jury would not have a legally sufficient evidentiary basis to find for the party on that issue. The defendant here had spotted some evidentiary gaps at trial on the issues of product defect and whether such defect actually caused the injury. Nevertheless, the court concluded that the plaintiff had presented sufficient evidence for a reasonable jury to find in her favor on her strict liability and negligence design defect claims.

The Rule 59 motion for a new trial did succeed, and that is a big deal. Getting a new trial is not quite as tough as getting judgment as a matter of law, but the standard is still onerous. In this case, the questions were whether there was an error in the admission of evidence, whether the improperly admitted evidence likely had a substantial influence on the jury, and whether the result reached was inconsistent with substantial justice. Remarkably, the court answered these questions in the affirmative, threw out the verdict, and ordered a new trial.

What was the improperly admitted evidence? The plaintiff introduced a defendant employee email chain that attached a table listing patients who died after implantation of the defendant’s IVC filters — some, but not all, of those filters being the same one at issue in the case. Mind you, the plaintiff in the case most definitely did not die, so it is easy to understand why this exhibit could be confusing and devastating. The attachment to the embank chain was a complaint summary regarding adverse events (AEs) that resulted in deaths. There is nothing nefarious about collecting or reviewing such information. There are specific FDA reporting obligations regarding death AEs.

Why would anyone dream of admitting the death email chain in a case not involving death? The court admitted the exhibit at trial, finding “it’s prejudicial” but “it’s probative on the issue of risk utility” and that the defendants objections went to weight and not admissibility.

The court came to regret that decision.

One category of evidence that plaintiffs often seize upon is other similar incidents. The burden is on the proponent of the evidence to show substantial similarity. Having the benefit of the trial record, the court concluded that the plaintiff did not satisfy that burden. The plaintiff was happy to use the emails to suggest both that the company was on notice of the defect and that the defect could cause very serious injuries. Death, to be sure, is serious. But there was not really substantial similarity between the deaths described in the email that were associated with the particular type of IVC filter, which involved fatal retroperineal hemorrhages, and the very much alive plaintiff’s injury, which involved a fracture resulting in strut pieces migrating to her thigh, psoas muscle, and spine.

Moreover, again exercising hindsight, the court deemed the death reports to be inadmissible hearsay. The emails were written between the defendant’s employees, but they were “merely recording information provided by third parties.” The plaintiff argued that the emails and attachment were statements against interest, but the material statements were not statements by the defendant or its employees. There was also nothing in the record to show that the company was adopting the information as true.

The court also included that the email chain, as utilized by the plaintiff at trial, ran afoul of Fed. R. Evid. 403’s proscription against evidence that is unfairly prejudicial. The lack of similarity with the plaintiff’s injury and the hearsay factor meant that the email’s probative value was minimal. Meanwhile, the plaintiff lawyer milked the death issue for all it was worth, and then some, in direct exams and cross-exams. This milking culminated in the closing argument (both initial closing and rebuttal), when the plaintiff lawyer “referred to death and dying a multitude of times.”

Consequently, the court held that the erroneous admission of the death email “successfully crossed the hurdle from harmless error to prejudicial error.” (It is hard to argue that something was harmless error if you lingered on the point in closing argument. When we prosecuted cases in Los Angeles back in the 1990s, if we ever got something into evidence on a close call, such as a prior conviction, we usually avoided emphasizing it in closing argument. We could count on the jurors discussing it during deliberations. We took care to give the Ninth Circuit one less reason to reverse.)

As mentioned above, getting a new trial is no easy thing. The court in the IVC filters case did “not come to this conclusion lightly. It has thoroughly reviewed the 4,000-page trial transcript and the parties’ memorandums of law.” The court showed admirable diligence. And then it showed admirable integrity by deciding that the email had been erroneously admitted and that it likely “had a substantial effect on the jury’s verdict.”

Today’s topic is something a little different.  We don’t usually think of after market modifications to prescription drugs and medical devices.  If this were a blog about cars, computers, or almost anything with a motor or engine that can be enhanced for speed – user modifications would be a central theme. In the drug and device world when we talk about things that happen “after market,” we’re usually talking about off-label uses.  It’s not so much that the product is changed as the use is changed.  But the decision to us the drug/device in a way other than according to its label is one made by the physician after the product has left the manufacturer’s control.  That after sale choice by the doctor is not a defect for which a manufacturer is liable.

The product at issue in Lowe v. Cerner Health Services, 2020 U.S. Dist. LEXIS 218240 (E.D. Va. Nov. 20, 2020) was an electronic health record system (“EHR”) — a computer system designed to allow healthcare providers to submit orders and prescriptions and record medical information electronically.  The EHR at issue was a “framework” with a variety of options and dropdown menus designed to be configured by the purchaser to meet its needs.  In this case, the EHR was purchased by a hospital, was configured by the hospital, and had been in use at the hospital for six years prior to the plaintiff’s injury.  Id. at *2.  The incident occurred when a doctor put an order into the EHR for continuous monitoring of the patient’s pulse oximetry but based on her selections, the system defaulted to a “start” time of 10:00 am the next morning.  The patient was not monitored and was found in respiratory distress.  Id. at *10-12.     Plaintiff settled with the hospital and sued the manufacturer of the EHR system.  The EHR manufacturer moved for summary judgment on both the design and failure to warn claims.

Plaintiff proffered testimony from two experts that the EHR could have contained design features that would have made it safer.  But what those experts failed to do is explain what standard of care the manufacturer was at odds with.  That’s because the product complied with all industry and governmental standards.  Id. at *16-17.  So, plaintiff’s experts tried to argue that a different standard should apply.  That standard, however, had been rejected by the governing body and therefore was inapplicable.  Id. at *17-18.

Without evidence of violation of an accepted standard of care, plaintiff’s only other recourse was the reasonable consumer safety expectations test.  Under Virginia law, a plaintiff can prove consumer expectations through evidence of industry practices, knowledge of other injuries, knowledge of the danger, published literature, and direct evidence of what of a reasonable purchaser considers defective.  Id. at *19.  It was already established that the EHR complied with industry standards.  The evidence also showed that the manufacturer had received no customer complaints or incident reports similar to what was alleged in this case.  Not even the hospital where this event took place reported it to the manufacturer.  Finally, plaintiff’s expert’s subjective beliefs as to how the system could be better were insufficient to meet an objective standard.  Id.  at *19-20.

Plaintiff’s case also failed because he could not prove the defect existed at the time of sale.     The opinion goes into significant detail about the hospital’s control over the modifications made to the EHR, the fact that the system was designed to allow for those modifications, that the manufacturer was not consulted about the modifications, and the healthcare provider’s ability to review and confirm the orders before they were entered.  Therefore, the only defect alleged is based on the choice made by the hospital after market.  The EHR had been substantially changed after purchase and changed multiple times between purchase and plaintiff’s surgery.  For all these reasons, plaintiff could not sustain a design defect claim.

On failure to warn, the first key element is that the manufacturer “knew or had a reason to know that the product was likely to be dangerous for its intended use.”  Id. at *22-23.  As already noted, defendant had no knowledge of any other patient incidents and had no reason to know that the hospital, a sophisticated purchaser, would not understand any purported dangerous conditions in the settings it chose itself.  Id. at *23-24.  Plaintiff pointed to three adverse event reports from the FDA database, but had no information on how those EHRs were set up so could not show if the events were substantially similar to the event in this case.  Plaintiff’s expert tried to rely on an event that involved no allegation of physical injury, making any inference he drew from that data merely speculative.  Id. at 24-25.

Finally, on causation the record evidence showed multiple possible causes of plaintiff’s injury – the hospital, the doctor, the nursing staff.  Plaintiff’s experts failed to rule out these other causes which was fatal to plaintiff’s claims.  Id. at *27-28.


Although as of yet the data has not been peer reviewed, or subjected to the necessary administrative and scientific scrutiny, there has been considerable recent good news  regarding the efficacy of two COVID-19 vaccines, being developed by Pfizer and Moderna, respectively.

It is now more likely than ever that within a few months the largest mass vaccination effort in decades will occur as governments across America and around the world seek to create herd immunity to COVID-19 by something other than the current do-nothing, non-efforts we see in all too many places.

While we hope and expect that PREP Act Immunity will preclude massive civil litigation over the risks – real or imagined – of these (and hopefully other) COVID-19 vaccines,  we thought it appropriate to at least dust off and examine the body of law that had developed concerning liability for mass vaccinations in years past, without the benefit of modern legislation like the PREP Act.

Probably the most significant of the mass vaccination cases was Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), written by Judge John Minor Wisdom (whose lofty reputation does not rest on his product liability decisions).   Reyes both adopted the learned intermediary rule under Texas law and simultaneously recognized an exception to the rule for situations, as in Reyes, where an ordinarily prescription-only product was dispensed essentially without physician intervention.  Id. at 1270 (vaccine “administered . . . by a registered nurse; there were no doctors present”).

Reyes recognized that vaccines were “unavoidably unsafe” products under Restatement (Second) of Torts §402A, comment k (1965):

[I]t [is] what the Restatement calls an “unavoidably unsafe product,” one which cannot be made “safe” no matter how carefully it is manufactured.  Such products are not necessarily “unreasonably dangerous,” for as this Court has long recognized in wrestling with product liability questions, many goods possess both utility and danger.

498 F.2d at 1273 (citations omitted).  Applying the unavoidably unsafe standard in Reyes (also called, in 1970s parlance “unreasonably dangerous per se”) meant that:

[T]he scales must tip in favor of availability.  The evil to be prevented – [the disease and its symptoms] − is great.  Although the danger that vaccinees may contract polio is qualitatively devastating, it is statistically miniscule.

Id. at 1274.  Rather, the duty created by an unavoidably unsafe product is to provide warnings about its unsafe attributes.  Id. at 1274-75.

This duty to warn was subject to the learned intermediary rule:  “where prescription drugs are concerned, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use.”  Id. at 1275 (footnote omitted).  But, although “there is no question that [the] vaccine is licensed for sale only as a prescription drug,” it was not in fact used in that fashion.  Id. at 1276.  Hence the exception:

[W]here no individualized medical judgment intervenes between the manufacturer of a prescription drug and the ultimate consumer, “it is the responsibility of the manufacturer to see that warnings reach the consumer, either by giving warning itself or by obligating the purchaser to give warning.”  Where there is no physician to make an “individualized balancing . . . of the risks” . . . the very justification for the prescription drug exception evaporates.

Id. (quoting Davis v. Wyeth Laboratories, 399 F.2d 121, 131 (9th Cir. 1968)).  Where a prescription medical product manufacturer “knows or has reason to know that it will not be dispensed as such a” prescription product, then “the manufacturer is required to warn the ultimate consumer, or to see that he is warned.”  Id.

Reyes held that the evidence established this exception, whether plaintiff’s inoculation occurred during an actual  “mass” vaccination, or as part of an “ongoing program” did not matter as long as the product was “dispensed without the sort of individualized medical balancing” that doctors perform when they prescribe drugs.  Id. at 1277.  Further, the facts established the defendant’s at least constructive knowledge that what happened was likely:

[Defendant] had ample reason to foresee the way in which its vaccine would be distributed.  A drug manufacturer is held to the skill of an expert in his field, and is presumed to possess an expert’s knowledge [and] . . . familiarity with practices . . . common in the drug industry as to distribution and administration of pharmaceutical products.

Id.  It was “well known” that most polio vaccinations were “dispense[d] . . . to all comers in an ‘assembly line’ fashion” with “neither time nor personnel to make an ‘individualized medical judgment’ of the vaccinee’s needs or susceptibilities.”  Id. (quoting Davis and law review articles – even back in the 1970s law reviews were advocating liability at the expense of public health).  Further, the duty to warn imposed in Reyes was two-fold – either “warn foreseeable users [itself], or see that the [vaccination program sponsor] warned them.”  Id. at 1278-79.

In Davis, the case most heavily relied upon in Reyes, the defendant, through its regional sales representative, had been much more involved in the vaccination process than in later cases:

[O]ne of appellee’s salesmen, was assigned to handle the sales and assist in setting up the clinics. . . . [H]he managed the campaign for the [local] Medical Society.  He furnished books to those in charge of clinics, setting forth schedules and procedures to be followed and details of the physical manner in which the clinics were to be set up and also showing sample promotional letters and advertising matter. He arranged for delivery of the vaccine. . . .  He arranged for the printing of forms and immunization cards and posters urging ‘KO Polio’. . . .  He organized meetings and conferred with those in charge of the separate clinics as to the procedures to be followed.

399 F.2d at 125.  One might say that no good deed goes unpunished.

That was because, supposedly, “[n]o effort was made by [the representative] or the medical society to inform the [person who administered the vaccine] of the existence of risk.  The latter did not read the package insert, nor did appellant.”  Id.  Without even mentioning Erie, Davis adopted strict liability as the law of Montana.  Id. at 127.

[W]e conclude that strict liability does attach to sale of the drug to appellant and that the jury should have been so instructed, either by such an instruction as that requested by appellant or otherwise.  Our conclusion in this respect is based upon our determination that a duty to warn existed.

Id. at 126.  Even if the risk is “less than one out a million,” if it is both known, and serious, “the warning must be given.”  Id. at 129-30.  Davis was influenced by the underlying disease not being active in the area:

[W]here the end sought is prevention of disease (and the likelihood of contracting the disease from natural sources is a relevant factor) the situation is a different one from that in which the disease has already struck and the end sought is relief or cure.  Risks are far more readily taken in the latter case.

Id. at 130.  That, at least, is an argument nobody will be making about COVID-19 (even in Montana).

Since the defendant in Davis “knew that warnings were not reaching the consumer” from its participation in the mass vaccination program, a direct duty to warn was imposed.  Id. at 131.  Davis waved off cost and practicality issues as insignificant:

This duty does not impose an unreasonable burden on the manufacturer. . . .  [While] the vaccine came in bottles never seen by the consumer[,] . . . other means of communication such as advertisements, posters, releases to be read and signed by recipients of the vaccine, or oral warnings were clearly available and could easily have been undertaken or prescribed by appellee.


A third, somewhat more recent, decision further examined situations where vaccination occurred, allegedly in the absence of individualized medical evaluation.  Mazur v. Merck & Co., 964 F.2d 1348 (3d Cir. 1992), involved a mandatory school-based vaccination program undertaken in response to an epidemic whereby school nurses performed the inoculations.  Id. at 1351-52.  Individualized medical supervision was allegedly minimal:

[The school nurse] also examined the “overall appearance” of students as they passed by her, and, sometimes, asked them how they felt.  On average it took students three to four minutes to pass through the line and be vaccinated.  No physician was present during the inoculation, nor was any representative from either [the defendant] or the CDC.

Id. at 1351.

The “CDC” referred to the United States Centers for Disease Control.  Before the defendant would sell its vaccine for this mass vaccination program, the manufacturer insisted on CDC supervision of that program.  The CDC agreed to the following contractual provision:

The [CDC] represents and agrees that it will (1) take all appropriate steps to assure that all vaccine supplied to various locations within the 50 states, . . . pursuant to the terms of this contract, shall be administered to each patient on the basis of an individualized medical judgment by a physician, or (2) take all appropriate steps to provide to such a patient (or to the patient’s parent or guardian) meaningful warnings relating to the risks and benefits of vaccination, in form and language understandable to such patient, parent or guardian.

Id. (footnote omitted).

Reaffirming that vaccines are “unavoidably unsafe” products under comment k, Mazur held that negligence standards therefore applied.  Id. at 1353-5454.  Mazur then turned to the learned intermediary rule and the “mass immunization exception.”  Was the school nurse – the sole person administering the vaccine – a “learned intermediary”?  Mazur said no:

[N]urses generally are not capable of providing the degree of individualized medical judgment rendered by physicians, and are not authorized independently to prescribe drugs. . . .  As such, we do not believe the [learned intermediary] rule . . . or its rationale extends to nurses.

Id. at 1357 (citations, quotation marks, and footnotes omitted).  Nor did the facts convince the Mazur court that, in this instance, the nurse actually acted as a learned intermediary.  Id. at 1358-59 (“she was never trained in weighing the risks and benefits of vaccination in a given instance”).  Following Reyes and Davis, Mazur concluded that Pennsylvania would adopt the mass immunization exception and that it applied to these facts.  Id. at 1361-64.  Thus, the defendant could not prevail under the learned intermediary rule.

Ultimately, however, the defendant won.  Mazur held that the defendant “acted reasonably” when it “contracted with the CDC and relied upon its guarantee that the . . . vaccine would be administered by a physician or after a meaningful warning had been provided.”  Id. at 1364.  Because negligence standards applied, strict liability pronouncements that warning duties were “nondelegable” were “inapposite.  Id.  Under negligence principles (Restatement §388), “a manufacturer may meet its duty to warn by entrusting the communication of warnings to third persons.”  Id. at 1365.  Thus:

[A] vaccine manufacturer may satisfy its duty to warn in the mass immunization context by obligating the CDC to warn users directly if it informs that agency of the facts which make its vaccine dangerous and reasonably relies on it to communicate such information to users in lay terms. The manufacturer’s responsibility is continuous, and it must therefore apprise the CDC of any risks it later discovers or, in the exercise of reasonable care, should have discovered.

Id. (citation and footnote omitted).

Further, the warning statement drafted by the CDC was adequate as a matter of law.  Disposing of a variety of the usual plaintiff-side warning nitpicking, Mazur concluded “we believe [defendant] adequately informed the CDC of the facts which make its . . . vaccine dangerous.”  Id. at 1367.  Furthermore, it was reasonable for a vaccine manufacturer to rely upon a government agency like the CDC to distribute warning information to vaccine recipients.

Given the resources and funding available to the CDC, as well as its expertise in immunology and public vaccination, we believe [defendant’s] decision to rely on the CDC to warn users directly was reasonable. . . .  The CDC is an agency of the Public Health Service of the United States Department of Health and Human Services.  It is empowered to conduct studies, evaluations, tests, and emergency programs in order to prevent the spread of disease and to improve public welfare.  With respect to vaccines, it plays a vital role in research, development, testing, and distribution. It publishes the Morbidity and Mortality Weekly Report, among other reports, studies, and journals, to educate public health and medical professionals about the risks and benefits of immunization.

Id. at 1368 (quoting trial court opinion in part).  In light of the CDC’s expertise, the manufacturer had no duty to do more, such as “hire[] an independent contractor to review the CDC’s conduct.”  Id. at 1360.  Thus, as a matter of law, the vaccine manufacturer escaped liability in Mazur.

Taken together, Mazur, Reyes, and Davis illustrate the key issues that drive common-law liability analysis mass immunization cases.  Most jurisdictions to have addressed the issue, whether as part of a decision or in dictum, have recognized the so-called “mass immunization” exception.  Restatement (Third) of Torts, Products Liability §6(d)(2) (1998) (learned intermediary rule exception for “when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.”).  See also Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 950 (Ariz. 2016); Allison v. Merck & Co., 878 P.2d 948, 958 n.16 (Nev. 1994) (plurality opinion); Shanks v. Upjohn Co., 835 P.2d 1189, 1195 n.7, 1200 n.17 (Alaska 1992) (dictum); Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 692 (Miss. 1988); DiBartolo v. Abbott Laboratories, 914 F. Supp. 2d 601, 614 (S.D.N.Y. 2012) (dictum); Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 422-23 (D. Alaska 1987) (dictum).

First, vaccines critical enough to be distributed to the general populace are considered “unavoidably unsafe” productsSee also Petty v. United States, 740 F.2d 1428, 1441 (8th Cir. 1984) (applying Iowa law); Unthank v. United States, 732 F.2d 1517, 1523 (10th Cir. 1984) (applying Utah law); Givens v. Lederle, 556 F.2d 1341, 1344-45 (5th Cir. 1977) (applying Florida law); contra Allison, 878 P.2d at 955.  This proposition has since been written into law by the federal Vaccine Act, as discussed here.  Unavoidably unsafe status precludes design defect liability and focus the litigation on warning issues.

Second, the vaccine must be distributed without an individualized medical examination.  The lack of any physician-patient relationship is what defeats the application of the learned intermediary rule and gives rise to the duty to provide a warning directly to the person being vaccinated.  In vaccine cases where a physician-patient relationship exists, the mass vaccination exception should be inapplicable.  Petty, 740 F.2d at 1440; Stanback v. Parke, Davis & Co., 657 F.2d 642, 647 (4th Cir. 1981) (applying Virginia law); Krasnopolsky v. Warner-Lambert Co., 799 F. Supp. 1342, 1346 (E.D.N.Y. 1992).

However, even the presence of a doctor might not be enough for a court determined to impose liability.  Brazzell v. United States, 788 F.2d 1352, (8th Cir. 1986) (applying Iowa law), invoked the mass vaccination exception, claiming that the government’s efforts to encourage vaccine use had steam-rolled the plaintiff’s doctor:

In the instant case appellee did have the help of her doctor.  The doctor testified, however, that he knew nothing more about the vaccine than what the manufacturer and government had told him.  We hold that the doctor’s intervention is not enough to dispel the manufacturer’s duty to warn the ultimate consumer in view of the swine flu program’s exigent circumstances. The program was designed by the government to be at an emergency pitch and it gave physicians little chance to investigate the vaccine they were administering. The only possible sources of information on the vaccine were the manufacturer and the government who had developed and tested it.  The manufacturer, therefore, properly is charged with the duty to warn doctors and consumers of the risks involved. . . .  We have little trouble in viewing doctors in the program, rather than learned intermediaries, as distributors of a defective product.  As stated above, the emergency nature of the program forced this role on them.

Id. at 1358.  Cf. Givens, 556 F.2d at 1345 (despite plaintiff visiting a doctor, “the vaccine was administered here in a manner more like that at a small county health clinic”); Samuels v. American Cyanamid Co., 495 N.Y.S.2d 1006, 1013 (N.Y. Sup. 1985) (mass vaccination exception could apply to vaccine administered by corporate doctor to corporate employee pursuant to corporate policy).

The takeaway here is that plaintiffs can be expected to use the mass immunization exception to demand direct warnings in almost any situation short of a full, one-on-one office visit, and maybe even then.

Third, the defendant must be responsible for the claimed failure to warn, notwithstanding any precautions it took.  If the defendant involves itself in the distribution of the vaccine, then it is likely to have a direct warning duty imposed.  However, the defendant can, contractually or otherwise, arrange for a third party – including a governmental entity – to be responsible for preparing and providing end user warnings.  Indeed, the FDA itself has largely taken over the business of approving patient vaccine handouts, such as this one.

However, at least before the FDA got involved, delegating matters to a government agency may not have been enough to avoid tort liability.  Unlike Mazur, Petty found the duty to warn effectively non-delegable:

We recognize that the government has attempted to statutorily assume the duty to warn the vaccinees, however, we do not find that this delegation thereby relieves the manufacturer from liability for any resulting inadequacy of the warning.  The duty to warn is imposed on the manufacturer and in a mass immunization context. . . .  Delegation of the duty does not, in itself, relieve the manufacturer of its obligation, nor should it insulate the manufacturer from liability for deficiencies in the manner in which the chosen intermediary effectuates the manufacturer’s duty.

740 F.2d at 1440.  Another court even challenged the government’s status as a non-biased messenger:

Given the CDC’s admitted biases against discouraging the use of vaccines, a jury could conclude that [defendant] knew or had reason to know that the CDC was not going to provide the truth about [defendant’s] product and did not, in fact, give proper warning

Allison, 878 P.2d at, 958 n.17 (quotation marks omitted).

These cases were all decided before preemption became a well-established defense in product liability cases, and to us demonstrate why preemption is a necessary defense.  Private plaintiffs have no business using state law to second-guess the actions of the FDA and the CDC in the midst of a pandemic.

*          *          *          *

From review of this largely historical collection of precedent, the overwhelming takeaway is that the need for PREP Act and Vaccine Act common-law tort immunity is self-evident.  If the common-law trend evident in these mass vaccination decisions had continued unabated over the intervening decades, there would likely be no vaccines today.  Both the scope of the “mass vaccination” exception to the learned intermediary rule, and the defense of reliance on third-party – usually federal government – to provide warning were under constant pro-plaintiff pressure in the courts, until Congressional intervention largely shut down vaccine-related litigation.

We believe that, by knowing what is out there, putative defendants in any COVID-19 vaccination litigation will be better equipped to argue for both the existence of federal preemption and accompanying tort immunity, and to articulate the sound social policies that support it, in the context of the upcoming effort to vaccinate the public against COVID-19.

Finally, as to this last point, ensuring that the FDA utilizes sound scientific criteria – and only scientific criteria – in making COVID-19 vaccines available to the public will be far more essential to the success of such programs than any amount of litigation.  Vaccination programs will only succeed if the public is convinced that these vaccines have been rigorously evaluated for safety and effectiveness, and we don’t need lawyers trashing science in order to make a buck.