Those of you following the fortunes of COVID-19-related litigation should check out these two recently decided cases:  Garcia v. Welltower OpCo Group LLC, 2021 WL 492581 (C.D. Cal. Feb. 10, 2021), and Fields v. Brown, 2021 WL 510620 (E.D. Tex. Feb. 11, 2021).

Garcia, the older of the two (by one day), addressed the ability of the PREP Act, 42 U.S.C. §§247d-6d, et seq., to create federal question jurisdiction in nursing home litigation over the alleged rationing of anti-COVID “covered countermeasures” in cases where there is no diversity of citizenship.  Regular readers will remember our post last December about the Department of Health & Human Services (“HHS”) declaration that significantly expanded PREP Act immunity to, inter alia, cases alleging failure to employ such countermeasures.  Garcia involved such allegations.  2021 WL 492581, at *1-2.  Even though there was no diversity of citizenship, the “senior living” defendants removed to federal court on the ground that PREP act immunity created federal question jurisdiction.  Id. at *2.

Plaintiffs in Garcia argued the PREP Act immunity did not apply to “negligence claims unrelated to vaccine administration and use.”  Id. at *4.  They also asserted that “fail[ure] to adhere to infection control protocols . . . do[es] not receive PREP Act immunity.”  Id. at *5.  Both contentions failed.  Contrary precedent preceded, and thus could not have considered, more recent HHS declarations expanding the scope of PREP Act immunity.

[E]ach of these cases precedes more recent guidance from [HHS] which suggests that when a party attempts to comply with federal guidelines – in this case, concerning the COVID-19 pandemic – the PREP Act would provide complete preemption. . . .  [A]s recently as February 2, 2021, a court within this district found that the PREP Act does not provide for complete preemption.  However, it is not clear from that order if [that] court even considered the [more recent] Advisory Opinion. Therefore, the Court declines to defer to that decision.

Id. at *6 (citations omitted).  “That the Advisory Opinions are not binding law or formal rules issued via notice and comment does not render them irrelevant.”  Id.  Decisions imposing a “black and white” distinction between “use or non-use of a covered countermeasure” were erroneous – as pointed out by HHS – because they ignored “the plain language of the PREP Act, which extends immunity to anything ‘relating to’ the administration of a covered countermeasure.”  Id. (citation and quotation marks omitted).  PREP Act immunity can be defeated only where the defendant did nothing at all, not where the adequacy of its COVID response is at issue.  Id. (exception only for “total inaction”).

For all of these reasons, Garcia held that the PREP Act was a “complete preemption” statute that created federal question jurisdiction.

While the Court acknowledges that certain allegations [in the complaint] relate to a failure to abide by local or federal health guidelines, those allegations related to momentary lapses. Taken as true, all [the complaint] discloses are possible unsuccessful attempts at compliance with federal or state guidelines – something which the PREP Act, the Declaration, and the January 8, 2021 Advisory Opinion cover. . . .  Therefore, because [HHS] stated that the PREP Act is a complete preemption statute, the Court finds that an adequate basis for federal question jurisdiction exists.

Id. at *9 (citations omitted).

Thus, should Garcia’s rationale prevail, just about all nursing home litigation involving alleged failure to use countermeasures in a way that could have prevented COVID infections will be heard in federal court – regardless of how many questionable, non-diverse defendants plaintiffs try to add.

Our second case, Fields, involves the application of federal question jurisdiction arising from the defendant “acting under” the authority of a federal officer under 42 U.S.C. §1442.  We suggested the defense counsel give that basis for removal another look last year in this post, which was about the Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286 (5th Cir. 2020), decision – which is the precedent on which Fields turned.  Fields involved allegations about COVID infections in meat packing plants.  2021 WL 510620, at *1.  However, when COVID appeared to be posing a threat to the nation’s food supply, the government invoked the Patriot Act, and declared the defendant’s facilities to be “critical infrastructure.”  Id. at *2.

As defendants note, after this designation, [defendant plant owner] interacted with multiple government agencies, namely by being “in close contact with officials at the U.S. Department of Homeland Security and the U.S. Department of Agriculture regarding continued operations.” [It] also participated in a meeting between [the administration] and other food industry executives “to discuss the stability of the supply chain.”  Part of the collaboration between [owner defendant] and the federal government involved it working directly with the United States Food Safety and Inspection Service (FSIS).

Id. at *3 (record citations omitted).

This critical infrastructure designation meant that the owner defendant was subject to more than just general federal regulation.  Id.

[D]efendants here exhibited an effort to help assist, or carry out, the duties and tasks of the federal superior.  Defendants did so by working directly with the Department of Agriculture and the FSIS to guarantee that there was an adequate food supply.

Id. (citation omitted).  Indeed, Congress “allocated additional funding” to the relevant agency “to ensure that [it] had the resources to adequately supervise” facilities that had received the “critical infrastructure” designation.  Id.

Accordingly, the court now finds that, based on the critical-infrastructure designation, defendants were “acting under” the directions of federal officials when the federal government announced a national emergency.

Id. (footnote omitted).

Then, Fields judged the connection between federal oversight and the plaintiffs’ claims under the new, “more relaxed” standard discussed in Latiolis.  2021 WL 510620, at *4.  That step was relatively easy:

The purported act under color of federal authority is the decision to maintain operations despite the pandemic.  Naturally, the choice of what safety precautions should be taken . . . connects to the broader decision to keep the plant open during the pandemic in the first place.


Finally, step three – a “colorable” federal defense to the plaintiffs’ claims – was satisfied by defendants raising two forms of preemption:  (1) express preemption under meat inspection statutes, and (2) implied conflict preemption with governmental oversight under the Defense Production Act.  Id. at *4-5.  Defendants did not have to win preemption at this point; they only had to have a “plausible” basis for the defense, which they did.  Id. at *5.

Thus, should Fields’ rationale prevail, all COVID-related litigation over infections allegedly arising from meatpacking and other facilities designated as “critical infrastructure” during the pandemic would likewise be heard in federal court.

Between Garcia and Fields, precedent now exists for the exercise of federal jurisdiction over the vast majority of COVID-related personal injury litigation.

Given the events of the last eleven months or so, we give ourselves and other legal commentators a preemptive pass for the following situation:  you read a case, you think about how you would describe it, and you see that you have described similar cases in a similar way more than once.  This could be due to low batteries in our déjà vu detector or that there is so much repetition from day to day to week to month that it interferes with the detector.  Either way, we can crank up another detector, our retrospectoscope for legal trends, and see that there seem to be many cases these days where a plaintiff argues for an exception to the learned intermediary doctrine.  Like a plaintiff advocating a novel theory of causation/defect in court, we require no study or statistics to support our assessment of a trend.  Instead, we can declare it to be true based on an anecdote or two and, hearing no disproof on our precise terms, turn to speculating about the factors contributing to the trend.

Mockery aside, we do think there are some reasons for the trend, although it is hardly something we have seen over just the last year.    First, pretty much everywhere has adopted the learned intermediary doctrine by now.  When we started tracking it on this Blog back in 2007, it was a majority, but even laggards like Arizona and Wisconsin have joined the learned intermediary party.  The next step in the world where plaintiffs never stop trying to sue is to argue exceptions.  Second, a generally good trend—there we go again—on preemption for warnings claims against makers of prescription drugs, generic drugs, and PMA devices has pushed plaintiffs to seek out new claims that they hope will not be preempted.  Warnings-based claims that involve communications with patients may be less likely to get preempted, assuming they can get a court to carve out an exception for them.  Third, the law has also been moving in a good place—there is some other term for that—when it comes to what a plaintiff has to prove in terms of proximate cause for failure to warn when the focus is on a prescribing physician.  The plaintiff may be more willing to testify that an additional warning would have changed her behavior than would a licensed medical provider who should actually be keeping up with the medical literature and making individualized risk-benefit decisions.  Fourth, Erie restraint does not seem to be highlighted in the training of federal district judges these days, so, if a case ends up in federal court on diversity, then why not try and make some new state law if it helps your case?

We declare these all to be plausible reasons for more attempts, particularly in federal court, to create exceptions to the learned intermediary doctrine in ways that would help prescription medical product plaintiffs avoid summary judgment.  Trying does not always make it so and, two years ago, we reported on summary judgment for the makes of a prescription contraceptive device in a case called Ideus.  We lauded the district court’s rejection of an argued contraceptive exception to Nebraska’s learned intermediary doctrine.  Well, two years was a long time ago, long enough for us to forget about the prior decision while the appeal to the Eight Circuit was pending.

Ideus v. Teva Pharms USA, Inc., __ F.3d __, No. 19-1361, 2021 WL 415774 (8th Cir. Feb. 8, 2021), is a short and forceful opinion affirming the decision below.  The facts are relatively straightforward, at least for the issue on appeal.  While conceding that the physician labeling was adequate, the plaintiff contends that the patient package insert (“PPI”) that accompanied her prescription intrauterine device (“IUD”) was somehow inadequate and contributed to her needing to have the IUD surgically removed at some later point.  As the court says of the PPI, “Before implanting the device, physicians are supposed to give plaintiffs time to read [the PPI], discuss it with them, and answer any questions.”  Id. at *1.  That makes it hard to separate out completely the warnings to the physicians and their interaction with patients, but we can set that aside for now.  If the Nebraska Supreme Court would apply the learned intermediary doctrine to this case, then plaintiff had no claim.

The starting point was that the Nebraska Supreme Court had already adopted the learned intermediary doctrine, as set out in Restatement (Third) of Torts, § 6(d), in a prescription drug case called Freeman v. Hoffman-La Roche, Inc., 618 N.W. 827 (Neb. 2000).  Predictably, plaintiff started by arguing that Freeman applied only to prescription drugs, not prescription devices, so it was the defendant who wanted to extend Nebraska law, instead of her trying to create a new exception.  Nope.  On its face, section 6(d) applies to “[a] prescription drug or medical device.”  Id. at *2.  We think “prescription” modifies both “drug” and “medical device” in 6(d), so this is even more of a no-brainer than the Eighth Circuit made it.  The court noted that, “just like [the drug in Freeman], [the device in Ideus] is prescribed by physicians, so it fits within the rationale for the rule:  they will be ‘in the best position to’ advise their patients about the risks of using it.”  Id. (citing Freeman).

Plaintiff did not give up, focusing her request for adoption of a contraceptive exception on one Massachusetts case and two Michigan federal cases, all from 1985.  Noting that later Michigan federal cases and the Sixth Circuit had come out the other way, the court declared that “The bottom line is that Massachusetts stands alone in unequivocally adopting” an exception.  Id.  We would throw in that the well-known Michigan product liability statute in place since 1996 was another strike against the older predictions of Michigan law.  But this was not nearly as important as the explicit rejection of the Massachusetts cases by more than a dozen other states and many federal courts.  (Our post on the decision below contains a more complete collection.)  In product liability law, if a decision from a state high court has been around for thirty-five years without being followed by another state high court or any federal appellate court, then it is decidedly an outlier.  There was no reason to believe Nebraska would go that route.  Id. at *3.

Plaintiff’s last chance was to point out that the Eight Circuit had predicted in 1989 that Arkansas would not apply the learned intermediary doctrine in an IUD case.  However, in the interim, Nebraska had adopted the majority position and majority position had been strengthened considerably.  Id.  (Arkansas had too, back in 1991.)  So, the court had no compunction about affirming.  Id.

We do have one complaint, though, which you might have guessed.  In the discussion of predicting what the Nebraska high court would do, there is no discussion of Erie restraint.  There is a dissent that argues that a question should have been certified for the Nebraska Supreme Court itself.  While certified questions are a useful procedure that probably should be used more often by courts sitting in diversity, the existence of the Freeman decision made possible a prediction consistent with Erie restraint, a concept the dissent also ignored.

February is a fine time to cuddle up with a good book or a short case. Take a look at In re Xarelto Products Liability Litigation, 2021 WL 493069 (E.D. La. Feb. 10, 2021). Pro se plaintiffs brought a lawsuit claiming their relative died from a brain hemorrhage caused by Xarelto. Their case was sent to the Xarelto MDL, where it was something of a latecomer. By this time, a Master Settlement Agreement (MSA) was in place, and the opt-in rate was exceeding 99%.

The MDL court had entered Case Management Order (CMO) 11, which applied to any plaintiff who had not signed onto the MSA. CMO 11 imposed several requirements upon non-settling plaintiffs, including the filing of a case specific Rule 26(a)(2) report from a licensed physician to the effect that the drug caused the injury. That requirement is affectionately known as a Lone Pine order, because it debuted in a New Jersey case of that name. Lone Pine orders are, along with the incandescent light, the submarine, transistors, air conditioning, and Newark hot dogs, among the greatest inventions in the history of the Garden State.

As the Xarelto court tells us, the “basic purpose of a Lone Pine order is to identify and cull potentially meritless claims and streamline litigation in complex cases.” We love them, plaintiffs hate them, and courts seem reluctant to impose them until some big-time settling has already occurred. Why, it’s almost as if some courts view Lone Pine orders as rewards to defendants who opened up their wallets – or as cudgels to rap the hands of holdout plaintiffs.

The pro se plaintiffs had not complied with the Lone Pine order, even though the court gave them several extensions. The defendants moved to dismiss the complaint.

Why not dismiss the complaint? What was the pro se plaintiffs’ excuse? The question almost answers itself, doesn’t it? The pro se plaintiffs did not comply because they were pro se plaintiffs. They asked the court to appoint pro bono counsel for them. The court refused, pointing out that, as a general matter, litigants have no right to court-appointed counsel in a civil case, and this wasn’t one of the exceptional circumstances calling for a different result. One wonders why no contingent fee counsel swooped in to the rescue. Could it be that the case was bereft of merit?

It’s not as if the pro se plaintiffs lacked eloquence. Here is how they explained their inability to secure a Rule 26(a)(2) causal affidavit:

The only way Plaintiffs could have complied with CMO 11 Rule 26 requirement was to commit the crime of kidnapping a licensed physician at gunpoint, hold him/her hostage, torture him/her until he/she agreed to read the 859 pages of Dexter Brown’s medical records, and then murder him/her so that he/she doesn’t identify the Plaintiffs to the police … BECAUSE NO LICENSED PHYSICIAN WAS WILLING TO PREPARE THE RULE 26(a) REPORT VOLUNTARILY WITH OR WITHOUT PAY.

Rather than reward the pro se plaintiffs’ admirable restraint and candor, the court dismissed the case with prejudice for failure to satisfy the Lone Pine order. Pity.

Actually, the real pity is that courts do not issue Lone Pine orders more often and sooner. It is not only pro se plaintiffs who cannot come across with causal affidavits; big chunks of bloated case inventories assembled by esquires will also exit the docket.

This case has been added to our Lone Pine cheat sheet.

We are six weeks into 2021 and for most, it stills feels a lot like 2020.  We are starting to hear about restrictions being lifted or modified to allow for more . . . well more anything.  But that’s happening just as almost the entire country is being overwhelmed by a polar vortex.  Ice, snow, and sub-zero temperatures are being reported from Washington to Texas to Virginia.  So, just as your favorite restaurant may be opening back up, you may be too busy shoveling snow or too content by the fireplace to venture out right now.  If the winter is determined to keep us in a bit of a 2020 shut-in re-run, why not talk about a 2020 case.

The decision granting summary judgment to the product manufacturers in Estate of William O’Dowd v. Sims, 2020 WL 8414373 (N.J. Super. Law Div. Jun. 8, 2020) just recently popped up on Westlaw and reaffirms the importance of product identification in an over-the-counter drug case.  Plaintiff was a diabetic who underwent foot surgery, after which he continued to experience discomfort.  His doctor advised him to get “some padding.”  Id. at *2.  According to the complaint, plaintiff then purchased callus removers.  Continuing to experience problems, plaintiff returned to the doctor and was diagnosed with an ulceration due to the medication on the corn remover and it appears that plaintiff eventually had to have an amputation.  Id.  This all occurred in 2015.  The lawsuit was initiated two years later and one and half-years after filing, plaintiff died of an unrelated cause.  Id. at *1-2.  Plaintiff’s sole allegation against the manufacturer was that the product’s packaging did not contain an adequate warning.

Importantly, however, plaintiff did not retain the actual product he used or its packaging and he died before being deposed.  Those two events proved fatal to his case.  The opinion details several meetings with counsel during which different packages were shown to him (i.e., asbestos-style coaching) in an attempt to identify the product.  Id. at *3.  According to plaintiff’s counsel, plaintiff identified the color of defendant’s packaging “as being more representative of the product he used.”  Id.  Does not sound like a definitive identification, but the real problem was the lack of any sworn testimony or records to support even that tentative recollection.

On analysis, the court was rightfully concerned that there was a major evidentiary deficiency in plaintiff’s case.  Plaintiff could not attest to what the packaging looked like and neither could any other witness.  The only thing the estate could offer was the inadmissible hearsay testimony of family members (some of it conflicting) and counsel.  Id.  Leading the court to conclude:

[T]he most important [question] is whether Plaintiffs can apprise the Court with a credible identification of the actual product at issue.  The case against Defendants . . .  is one for failure to adequately warn a patient . . . of the product’s risks.  This count necessarily relies on a credible identification of the packaging actually used by a plaintiff so that a jury may evaluate that particular packaging’s ability to warn the consumer of its risks.  The Court is satisfied that Plaintiffs are unable to properly identify – with admissible evidence – the specific packaging used by [plaintiff].

Id. at *6.

The court goes on to examine each statement offered by the estate on product identification and explains why each is inadmissible hearsay not subject to any exception.  Id. at *6-7.   Plaintiffs asked the court to consider all of the family hearsay statements together to conclude that they were trustworthy.  But that missed the mark because hearsay statements must be independently evaluated.  “[T]here is no lots of hearsay exception to the hearsay rule that supports trustworthiness.  Plaintiffs cannot offer hearsay to support the credibility of other hearsay.”  Id. at *6.  As for the statements made to counsel where multiple packages were shown to plaintiff, the court could not conclude those were trustworthy as they were made while preparing for litigation nearly two years after the product was used.  Id. at *7.  The estate also sought to rely on (i) plaintiff’s interrogatory responses, but those were not verified by plaintiff, and (ii) on his handwritten notes which were not admissible because he would not be testifying.  Id.  The court was left with no particular product that it was comfortable having a jury consider.  Therefore, summary judgment was granted.

But the court made a few additional findings.  Such as, plaintiff’s expert could not opine on a product without product identification.  An expert opinion must be founded on “facts or data.”  Id. at *4.  Here, plaintiff’s expert had neither.  He had never spoken to plaintiff before he died.  The only “fact” the expert relied on was plaintiff’s counsel’s identification of the product which was inadmissible.  Also, without product identification any “heeding presumption” issue was immaterial.  Id. at *8.  Next, plaintiff’s warning claim was also preempted under the applicable monograph for the OTC product.  Id. at *8-9.  The monograph prohibits statements outside its scope even if truthful and not misleading.  Id. at *9.  Therefore, “[p]laintiffs cannot have expected Defendants to violate federal law to change the wording of the label.”  Id.  Finally, the court concluded that the OTC product qualified for New Jersey’s presumption of adequacy for FDA-approved warnings.  Plaintiff first tried to argue that OTC warnings fall under the monograph but are not approved by the FDA, which the court rejected based on a review of relevant regulations identifying the FDA’s warning label requirements.   Id. at *9.  Plaintiff also argued that the language on defendant’s packaging did not exactly mirror the FDA’s required language.  But the court was unwilling to accept that “a deviation in grammar or syntax constitutes such a disruption that a drug is not in compliance with FDA requirements.”  Id.

It may be snowing or sleeting, or icing where you are, but that won’t last.  Needing product identification however is a re-run we’ll never tire of.

Several significant decisions have recently emerged from the In re Zantac MDL, No. 2924.  We gave you a “bare bones” rundown of the first four of them right away.  But now we’d like to discuss them in more detail.

We start with In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7866660 (S.D. Fla. Dec. 31, 2020), which as our bare bones post mentioned, gave the boot to the plaintiffs’ innovator liability claims.  This opinion has us bloggers jumping for joy for several reasons.

Innovator liability is involved in the Zantac MDL because that claimed product defect (a breakdown product that allegedly “increase[s] the risk of cancer,” id. at *1) was not discovered until well after the relevant patents had expired and generic versions of the product had captured most of the market share.  Id.  This type of substance – nitrosamines − is something anyone who consumes bacon, beer, or cheese has already been exposed to for many years (pills being a lot smaller).

The Zantac plaintiffs sued everyone they could think of, including the original branded manufacturers on claims of “innovator” liability:

Under this theory of liability, the consumers of a generic drug product may hold a brand-name drug manufacturer liable for failing to warn of a defect in the product − a product that the brand-name drug manufacturer did not itself make, sell, or distribute.

Id. at *3.  As the Zantac opinion states, and our innovator liability scorecard confirms, only two states in the country allow any form of this benighted and dangerous form of liability – California, and to a somewhat lesser extent MassachusettsId.

That only two states allowed this novel form of liability did not stop the Zantac MDL plaintiffs from arguing that the MDL court could predict that virtually every other state would do so, too.  This is an MDL, and MDL are notorious for ignoring state limits to liability.  See, e.g., In re Fluoroquinolone Products Liability Litigation, 2021 WL 396819 (D. Minn. Feb. 4, 2021) (MDL abuse on this very issue).

Not this time.

First, plaintiffs’ claims were whittled down a bit.  Initially they conceded “that their theory of liability is not viable under the laws of Alabama, Iowa, West Virginia, or Florida.”  Id. at *4 n.5.  After supplemental briefing was ordered, plaintiffs backtracked some more and decided not to contest Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, New Jersey, Ohio, Tennessee, Texas, and Washington.  Id.  That still left the Zantac plaintiffs arguing that innovator liability should be allowed in 35 jurisdictions:  Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Utah, Vermont, Virginia, Wisconsin, and Wyoming.  Id. at *6 n.6.

Since almost the day it was founded, the Blog has argued that it is improper under Erie Railway Co. v. Tompkins, 304 U.S. 64 (1938), for federal courts sitting only in diversity jurisdiction (which is the case in almost every drug/device MDL) from predicting that states would adopt novel theories of tort liability.  See our Erie Doctrine postsZantac backed that position to the hilt:

[W]hen a federal court is called upon to recognize a cause of action under a state’s laws that the state itself has yet to recognize, “considerations of comity and federalism counsel that [the federal court] proceed gingerly when venturing into uncharted waters of state substantive law.”  Guarino v. Wyeth, LLC, 719 F.3d 1245, 1251 (11th Cir. 2013) (declining to “manufacture” a law making brand-name manufacturers liable for the injuries of generic consumers “out of whole cloth,” in part, because no Florida state court had adopted such law); see also City of Miami v. Bank of America Corp., 800 F.3d 1262, 1289 (11th Cir. 2015) (declining “to invent a novel basis for unjust enrichment under Florida law” because the Florida Supreme Court had not yet ruled on whether such law existed and because of “the complete lack of supporting Florida caselaw”). . . .  The Court has the task of making an Erie prediction as to whether the highest courts of 35 jurisdictions would recognize Plaintiffs’ theory of liability.  In making its Erie predictions, the Court follows the Erie analysis steps set forth by the Eleventh Circuit.

2020 WL 7866660, at *6 (footnote omitted).

Thus, Zantac ruled that none of the 35 jurisdictions would dispense with the fundamental product liability requirement that the defendant have made that allegedly injurious product in order to impose on branded manufacturers liability for injuries caused by competing generic products.  An “overwhelming national consensus” has rejected innovator liability.  Id.  The most directly on point case was Guarino, in which the Eleventh Circuit had drawn this conclusion for Florida.  The most analogous case was In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 756 F.3d 917, 941–54 (6th Cir. 2014) – another MDL in which the plaintiffs had tried the same thing on a slightly smaller scale, and had been shot down under the laws of 22 states.  Zantac, 2020 WL 7866660, at *6.

If innovator liability is “construed” as a product liability claim, “then for those claims to be viable under the laws of jurisdictions that require product identification, Plaintiffs must allege that the drugs that caused their injuries were made, sold, or distributed by Defendants.”  Id. at *7 (citation omitted).  If such claims are construed as some sort of separate negligence/misrepresentation claim, then “Plaintiffs must establish that Defendants owed Plaintiffs a duty sufficient to trigger liability.”  Id.

Plaintiffs lost both ways.  “]T]he highest courts of all 35 jurisdictions examined would hold that it is settled law that product identification must exist for a products liability claim to succeed.”  Id.  Seven states with product liability statutes, Arizona, Arkansas, Colorado, Connecticut, Mississippi, North Carolina, and Oregon, “would hold that Plaintiffs’ negligence-based claims are, in reality, products liability claims because all of Plaintiffs’ claims stem from an injury caused by a product.”  Id.  So plaintiffs in those states lost without the need to examine negligence/misrepresentation separately.  Zantac examined the negligence and misrepresentation precedents of the remaining 28 states separately and:

predict[ed] that the highest courts of each of these jurisdictions would determine that Defendants do not owe a duty to Plaintiffs.  This prediction comports with the principles of comity and federalism, which counsel federal courts to proceed gingerly when venturing into uncharted waters of state substantive law.  Furthermore, this prediction is consistent with the majority view and is appropriate given the absence of any strong evidence that these jurisdictions would join the minority view.  Plaintiffs’ claims of general negligence . . . and negligent misrepresentation . . . against Defendants fail under the laws of these jurisdictions.  In conclusion, the Court predicts that none of the highest courts of the 35 jurisdictions would recognize Plaintiffs’ theory of liability.

Zantac, 2020 WL 7866660, at *8 (citations and quotation marks omitted).  Zantac included a lengthy appendix examining each state’s law separately.  We’ve added these state-specific discussions to our 50-state survey of innovator liability, so we’ll just provide the relevant citations here, so readers can check out the states that interest them most.  Alaska, 2020 WL 7866660, at *12-13; Arizona, 2020 WL 7866660, at *14; Arkansas, 2020 WL 7866660, at *15; Colorado, 2020 WL 7866660, at *15-16; Connecticut, 2020 WL 7866660, at *16-17; Delaware, 2020 WL 7866660, at *17; District of Columbia, 2020 WL 7866660, at *17-18; Hawaii, 2020 WL 7866660, at *18; Illinois, 2020 WL 7866660, at *18-20; Maine, 2020 WL 7866660, at *20; Maryland, 2020 WL 7866660, at *20-21; Michigan, 2020 WL 7866660, at *21-22; Minnesota, 2020 WL 7866660, at *22; Mississippi, 2020 WL 7866660, at *22-23; Missouri, 2020 WL 7866660, at *23-24; Montana, 2020 WL 7866660, at *24-25; Nebraska, 2020 WL 7866660, at *25-26; Nevada, 2020 WL 7866660, at *26; New Hampshire, 2020 WL 7866660, at *26-27; New Mexico, 2020 WL 7866660, at *27-28; New York, 2020 WL 7866660, at *28-29; North Carolina, 2020 WL 7866660, at *29; North Dakota, 2020 WL 7866660, at *30; Oklahoma, 2020 WL 7866660, at *30-31; Oregon, 2020 WL 7866660, at *31; Pennsylvania, 2020 WL 7866660, at *31-32; Puerto Rico, 2020 WL 7866660, at *32; Rhode Island, 2020 WL 7866660, at *32-33; South Carolina, 2020 WL 7866660, at *33-34; South Dakota, 2020 WL 7866660, at *34-35; Utah, 2020 WL 7866660, at *35; Vermont, 2020 WL 7866660, at *36-37; Virginia, 2020 WL 7866660, at *37; Wisconsin, 2020 WL 7866660, at *37-38; Wyoming, 2020 WL 7866660, at *38-39.

That alone is a significant victory, but Zantac wasn’t done yet.  Back in 2018, before any directly on point precedent existed, the Blog proposed that personal jurisdiction could be a good defense to innovator liability claims under Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017):

[W]e (well, Bexis) had been thinking about precisely that – the “suit-related conduct” in innovator liability cases does not take place in the plaintiff’s forum state (MA or CA) because the branded defendant didn’t sell the injurious product, so unless that defendant is unfortunate enough to be “at home” in those states, there shouldn’t be case-specific personal jurisdiction either.  Without a product sale there’s not even a stream of commerce argument.

Zantac adopted this argument as well, holding that plaintiffs from California and Massachusetts asserting innovator liability claims had to be dismissed for lack of personal jurisdiction.  The defendants were not “at home” (incorporated or with a principal place of business) in those states, and there was no specific forum-related conduct that those plaintiffs could assert.

Plaintiffs fail to allege specific, non-conclusory facts demonstrating that any of Defendants’ actions, including marketing and labeling decisions, took place in any state or territory, including California or Massachusetts, the only two states that recognize Plaintiffs’ theory of liability.  To establish specific personal jurisdiction based on Defendants’ activities in a particular state, Plaintiffs must allege that those activities were the “but-for” cause of Plaintiffs’ ingestion of generic ranitidine products and injuries.  Plaintiffs have failed to do so.  Additionally, Plaintiffs must allege that Defendants should have foreseen that their activities regarding their brand-name ranitidine products in that state could expose them to liability for injuries sustained from the ingestion of generic ranitidine products.  Again, Plaintiffs have failed to do so.

Zantac, 2020 WL 7866660, at *10 (citations omitted).  So, just as we thought they should, innovator liability claims brought under the laws of the only two states allowing such claims fail because, without a relevant sale or use of the defendant’s product, there was no forum-specific conduct allowing exercise of specific personal jurisdiction.

But, this is an MDL, so plaintiffs advanced yet another bizarre theory – this time that something called “legislative jurisdiction” allowed California and Massachusetts to assert innovator liability on an “extraterritorial” basis.  Id. at *11.  Nope.  Before a state can impose any form of liability, Due Process requires that it first be able to exercise personal jurisdiction.

“[F]or the same reasons that Plaintiffs failed to establish a prima facie case of specific personal jurisdiction over Defendants in any state or territory, the Court similarly holds that Plaintiffs have not established sufficient minimum contacts between Defendants and the states of Massachusetts or California, such that neither state may apply their substantive law extraterritorially in accordance with the Due Process Clause.”

Id. at *12.

A great win:  innovator liability, Erie conservatism, and personal jurisdiction all in the same decision.  Stay tuned for the next installment of the Zantac chronicles.

Have you ever gone to a party and felt unwelcome?  Neither have we, but the moving party in Bartis v. Biomet, Inc., No. 4:13-cv-00657, 2021 U.S. Dist. LEXIS 21048 (E.D. Mo. Feb. 4, 2021), sure must have felt that way.  She tried to join and intervene in a consolidated set of prosthetic hip-related lawsuits that she said were similar to her own.  Alas, the district court was an unwilling host and showed her the door.

Here is what happened.  The Bartis plaintiffs’ cases were part of an MDL, but were among multiple non-settling cases that the MDL judge remanded to transferor districts for further proceedings and trial.  These plaintiffs therefore landed back where they filed—in the Eastern District of Missouri—which consolidated their claims into one civil action.  Then, a whole new plaintiff—whom we will call the “moving party”—decided she wanted to join her own hip-related lawsuit to the plaintiffs’.

We understand the purported basis for the moving party’s attempted joinder—she was treated with the same metal-on-metal hip implant as the plaintiffs.  We do not, however, understand why she chose this route rather than proceeding with her own civil action.  Was she trying to horn in on an already-set trial date?  Was there discovery undertaken in the MDL to which she wanted to gain access?  Did counsel view it as administratively convenient to ride along with a case with more water under the bridge?

We don’t know, and it doesn’t really matter.  The order is important to us because it ruled that being treated with the same device does not alone justify joining different plaintiffs’ claims in one civil action.  There were just too many differences.  As the district court explained, permissive joinder under Federal Rule of Civil Procedure 20(a) (as opposed to required joinder under Rule 19) is permitted if the plaintiffs “(A) assert any right to relief . . . with respect to or arising out of the same transaction, occurrence, or series of transaction or occurrences; and (B) any question of law or fact common to all plaintiffs will arise in the action.”  The first part of this test—the “transactional link”—is a case-by-case inquiry that focused on the “logical relationship” between the claims.  Bartis, 2021 U.S. Dist. LEXIS at *4-5.  The second part the test requires “commonality,” much like commonality for class certification under Rule 23(a)(2).  Id.

The moving party failed to show a “transactional link”:  She was treated with the same device, but with different medical providers, and her implantation was four years later than the plaintiffs whose party she was trying to crash.  Id.  Because of the four-year difference, her surgeon received different Instructions for Use from the Defendant.  Id. at *6.  The IFU is, of course, the key conduit for communicating known and knowable risks and is critical to any warnings-based claim.

The district court denied joinder:  “[T]his Court concludes that the simple fact that [the moving party] also received a Magnum hip implant four years after Plaintiffs . . . from different medical providers relying on updated IFUs is not a sufficient logical connection to satisfy the transactional link requirement for permissive joinder.”  Id. at *7.  The district court further ruled that even if there were a transactional link, it would still deny permissive joinder because doing so late in the game would not “serve the interest of judicial economy.”  Id.

The district court similarly denied the moving party’s motion to intervene in the plaintiffs’ action.  A court may permit someone to intervene in a civil action “if they have ‘a claim or defense that shares with the main action a common question of law or fact.’”  Id. at *8.  In exercising this discretion, the primary factor is “whether the intervention will unduly delay or prejudice the adjudication of the original parties’ rights.”  Id.

Again, the claims were too different and the moving party was too late.  The plaintiffs’ lawsuit had been filed eight years earlier, and substantial discovery had occurred in the MDL.  Most significantly, the district court was “cognizant that Movants’ claim involved unique discovery and distinct legal considerations because [the moving party] received her implantation roughly four years after Plaintiffs.”  Id. at *9.

This is the correct outcome on these facts, but while the district court was particularly moved by the four-year difference in time, it would not take so much of a difference for claims based on treatment with the same device to lack a “transactional link.”  Many factors other than time distinguish medical device product liability claims from one another, including the plaintiffs’ conditions, medical histories, surgical technique, co-morbidities, and myriad other factors that make personal injury claims unique.  Indeed, differences like these make us question whether the district court should have consolidated the Bartis plaintiffs’ claims in the first place.  Regardless, the core ruling of Bartis is correct:  The simple fact that these patients were treated with the same device could not alone support joinder or intervention.

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

In future posts I will get to the point with little delay, but because this is my first post for the blog, a short introduction is in order.

I am partner in Winston & Strawn LLP’s Appellate & Critical Motions practice. Questions of federal preemption run through my practice. I defend clients in heavily-regulated industries, from medical-device and pharmaceutical manufacturers to providers of transportation and consumer-financial services.

In the medical-device space, I am the attorney who convinced the Arizona Supreme Court to repudiate the Ninth Circuit’s misguided Stengel decision, which badly mangled federal preemption law based on a misinterpretation of state failure-to-warn law. I’m also the lawyer who over the course of five years of national litigation built (with the help of colleagues, of course) what one court ultimately described as a “clear consensus” that federal law preempts tort claims predicated on the alleged off-label promotion of a medical device with premarket approval.

For the past 15 years I have had the pleasure of collaborating with—and learning from—Bexis. I am glad to be joining his merry band of bloggers.

Introduction complete, on to the actual subject of today’s blog post…

It is commonplace to invoke preemption when challenging state regulatory efforts or defending product-liability cases. Less common is raising preemption as a defense to commercial claims brought by a competitor. But the defendant in today’s case did exactly that—and won.

In Nexus Pharmaceuticals, Inc. v. U.S. Compounding, Inc., 2021 WL 342573 (C.D. Cal. Jan. 7, 2021), one pharmaceutical manufacturer sued another alleging unfair competition and unfair trade practices. The plaintiff sells “a ready-to-use ephedrine sulfate,” which “is used in surgeries to raise a patient’s blood pressure when the patient begins experiencing hypotension severe enough to affect the patient’s health.” Id. at *2. The defendant compounds drugs, i.e., “combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” Id. Like the plaintiff, the defendant “sells a ready-to-use ephedrine sulfate product.” Id.

Federal law regulates the sale of drugs. Generally, new drugs must be approved by the FDA before they may be sold. Compounded drugs are an exception to this rule; they do not require FDA approval. Still, section 503B of the FDCA, codified at 21 U.S.C. § 353b, “imposes a litany of other conditions” on the sale of compounded drugs. 2021 WL 342573, at *1. When produced in an “outsourcing facility”—i.e., by an entity rather than an individual physician or pharmacist—a compounded drug must be manufactured in a facility that is registered with the FDA. 21 U.S.C. § 353b(a)(1), (b)(1). If the compounded drug is made using “bulk drug substances,” it may be sold only if that substance appears on an FDA list. Id. § 353b(a)(2)(A)(i). Finally (for our purposes), federal law prohibits the sale of a compounded drug if it is “essentially a copy of one or more approved drugs.” Id. § 353b(a)(5).

The Nexus defendant operates an “outsourcing facility” to produce its ephedrine-sulfate product. 2021 WL 342573, at *1. The plaintiff claimed that sale of the defendant’s compounded drug violates the FDCA because the compounded drug is, allegedly, made using a bulk drug substance that does not appear on any of the relevant FDA lists and is essentially a copy of the plaintiff’s FDA-approved ephedrine-sulfate product.

Moving to dismiss, the defendant argued that the plaintiff’s unfair-competition and unfair-trade-practice claims were impliedly preempted by 21 U.S.C. § 337(a) as construed in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001).

As regular readers of the blog will know, § 337(a) declares that all actions to enforce the FDCA “shall be by and in the name of the United States.” This, said the Buckman Court, “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the [FDCA].” Id. at 349 n.4. In other words, § 337(a) impliedly preempts any state-law claim for which “the existence of [the FDCA] is a critical element in [the plaintiff’s] case.” Id. at 353.

According to the Nexus defendant, § 337(a) as construed in Buckman impliedly preempted the plaintiff’s unfair-competition and unfair-trade-practice claims because the purportedly wrongful conduct was alleged to be “unfair” only insofar as it violated federal requirements for the sale of compounded drugs.

The court agreed. It noted that the plaintiff was claiming that the defendant’s alleged “actions constitute unfair competition because” the defendant was “not following the rules—and those rules are the FDCA rules.” 2021 WL 342573, at *3. Thus, “[l]ike in Buckman,” the plaintiff’s “claims exist[ed] only because of the FDCA’s requirements.” Id. The court held that the plaintiff’s unfair-competition and unfair-trade-practice claims were therefore impliedly preempted by § 337(a), which makes clear that “the FDA … has the exclusive power to … enforce … the FDCA” and its restrictions on the sale of compounded drugs. Id.

The fact that the defendant’s alleged conduct purportedly violated federal law did not save the plaintiff’s state-law claims from dismissal. As the court noted, although the alleged violation of a federal requirement might allow a claim implicating a medical device to avoid express preemption, “implied preemption is ‘another hurdle’” that must also be cleared. 2021 WL 342573, at *3 (quoting Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013)).

And with that, commercial claims brought by one drug manufacturer against another were dismissed as impliedly preempted.

Approximately 18 months ago we reported on C.D. California cases that silicone breast implant defendants managed to keep in federal court and then get dismissed with prejudice. We expressed delight with the opinions because the court’s discussions of fraudulent joinder and preemption were particularly insightful. No doubt another source of our delight was that the author of the opinion was Judge Andre Birotte, a former colleague in the U.S. Attorney’s Office, and a person for whom our admiration is boundless.

Our blog accepts comments. Believe it or not, those comments do not always consist of unalloyed praise. We occasionally get portrayed as hard-hearted villains who gleefully trample on widows and orphans. That happened with our post on Judge Birotte’s decisions. How dare we extol a decision that slammed the courthouse door shut on grievously hurt plaintiffs? The comment included doubts about our fitness for polite company. Well, believe it or not, we are capable of human sympathy. We do recognize that some people are injured by bad conduct and deserve compensation. Still, we dwell in a world in which sometimes bad things happen to people through no one’s fault. We also dwell in a world in which every valid legal claim arrives accompanied by ten or one hundred others that possess more opportunism than merit. Clearly, though, the commenter would have none of that. She concluded by thanking the stars above that we were not the last word; there was always the Ninth Circuit.

The Ninth Circuit has now reviewed the cases. It would be churlish of us to say that the Ninth Circuit ruled that we were right. It would be accurate to say that the Ninth Circuit ruled that Judge Birotte was right. More specifically, the Ninth Circuit issued four memorandum dispositions affirming the district court’s rulings that disposed of 21 plaintiffs’ claims.

The four decisions are: (1) Nunn v. Mentor Worldwide, LLC, 2021 WL 406304 (9th Cir. Feb. 5, 2021), (2) Billetts v. Mentor Worldwide, LLC, 2021 WL 406313 (9th Cir. Feb. 5, 2021), (3) Sewell v. Mentor Worldwide, LLC, 2021 WL 406623 (9th Cir. Feb. 5, 2021), and (4) Vieira v. Mentor Worldwide, LLC, 2021 WL 406628 (9th Cir. Feb. 5, 2021). The four decisions are virtually identical.

The appellate court saw no error in the district court’s denial of the plaintiffs’ motions to remand because (a) the co-defendant’s deposition was “other paper” that provided sufficiently new information to trigger removal; and (b) there was clear and convincing evidence that the non-diverse defendant had been fraudulently joined. That defendant was not involved in manufacturing or supplying the silicone used in the implants. Recovery against that defendant was impossible.

The Ninth Circuit also upheld the district court’s ruling on the merits. The plaintiffs had attempted to evade preemption of their failure to warn claims by relying on the parallel claim exception. The plaintiffs’ failure to warn claims were premised on an alleged failure to report adverse event claims. Such a claim, sadly, has legs under California law (not too many other places), but here it was entirely too conclusory and speculative under Twombly. The plaintiffs postulated that if the defendant had conducted post-approval studies with more participants, it would have seen more adverse events, and then would have been required to report them to the FDA. Huh? Such counterfactual clairvoyance did not impress the court. In any event, there is no parallel state law duty (not even in California) supporting a claim regarding the conduct of post-approval studies. Further, there is no federal requirement to warn patients or doctors directly of adverse events.

The plaintiffs continued their tour circumnavigating preemption by relying on their manufacturing defect claim. For that claim to survive, the plaintiffs must allege that the defendants “deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device.” They cannot “simply demonstrate a defect or a malfunction and rely on res ipsa loquitur to suggest only … that the things speaks for itself.” The plaintiffs contended that the breast implants contained some unspecified materials that differed from those approved by the FDA. Nice try. The Ninth Circuit held that such vague allegations were insufficient because the plaintiffs did not allege which particular FDA requirement was violated.

The Ninth Circuit ended the opinions by acknowledging that it was “sympathetic to Plaintiffs’ health problems,” but still ruling that the complaint was bereft of legal support, and that Judge Birotte had not abused his discretion in denying the plaintiffs’ requests for leave to amend as futile.

If our critic remains unpersuaded by the Ninth Circuit’s reasoning, we hope she at least is open to the possibility that sympathy and dismissal can coexist. After all, the Ninth Circuit said so.

We offer a tip of the cyber cap to Dustin Rawlin and the Tucker Ellis team for achieving these results. They have done a splendid job of defending their client. If we continue to be the target of slings and arrows from our critics, we may turn to them for help.

We are not going to beat around the bush today.  When we see a “prediction” of an “expansion” of state law by a federal court, we have only one question.  What about Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78 (1938)?  That should have been a front and center question for the court in In re: Fluoroquinolone Products Liability Litigation, 2021 WL 396819 (Feb. 4, 2021).  We’ll give the court credit for not ignoring Erie completely.  Although perhaps the partial acknowledgement is worse than none at all.  Faced with a question of Illinois law that had not been addressed by that state’s highest court, the MDL court recognized that its role was to “predict” how that court would rule on the issue.  Id. at *5.  But the MDL court stopped short.  It neglected the rest of Erie doctrine which provides that

[a] federal court in diversity 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, 4 (1975).  In other words, a federal court sitting in diversity is not supposed to expand state law.  If a state has not recognized a cause of action, an MDL court should not be the first to do so.  Erie is a conservative doctrine aimed at ensuring that federal judges do not displace state law.  Where a state’s highest court has ruled on the issue, Erie means applying that rule.  Where a state’s highest court has not, “[t]he proper function” of a federal court “is to ascertain what the state law is, not what it ought to be.”  Klaxon Co. v. Stentor Electric Manufacturing Co., 313 U.S. 487, 497 (1941).  But that is precisely what the Cipro MDL court did when it predicted that Illinois would apply innovator liability, despite not a single Illinois state court ever having done so and contrary to Illinois Supreme Court decisions otherwise requiring product identification.  It decided what it thought Illinois law should be, rather than applying what it is.

Defendant, the brand manufacturer, moved to dismiss the claims of a plaintiff who admitted to only using the generic drug which was not manufactured or sold by defendant.  Those claims included product liability failure to warn, negligence, breach of express and implied warranties, fraud, negligent misrepresentation, fraudulent concealment, and consumer protection.  In re: Fluoroquinolone Prods. Liab. Litig., at *2.

With no law on directly on point, defendant argued that the governing law in Illinois, as decided by the Illinois Supreme Court, was that “[e]ach manufacturer owes a duty to plaintiffs who will use its drug or be injured by it. However, the duty is not so broad as to extend to anyone who uses the type of drug manufactured by a defendant[.]” Id. at *6 (quoting Smith v. Eli Lilly, 560 N.E.2d 324,  343 (Ill. 1990)).  So, per the highest court in Illinois, a fundamental requirement of bringing suit for harm caused by a product is that you must sue the manufacturer of the product you used, not the manufacturer of a similar product.

Not only is this the controlling law of Illinois, the Cipro MDL court admitted that the concept of innovator liability, or what it calls “warning label liability,” is a minority view.  It decided to read into Illinois law something that was neither recognized by that state or even by a majority of courts to have reviewed the issue.  Rather, it relied on one decision by an Illinois federal court that also ran roughshod over Erie to predict this expansion of Illinois tort law. Id.  A decision that was recently rejected by In re Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924 (S.D. Fla. Dec. 31, 2020)(predicting 35 states would reject innovator liability, including Illinois).  Also ignoring the Sixth Circuit’s prediction that innovator liability claims would fail under Illinois law.  See In re Darvocet, Darvon, and Propoxyphene Prods. Liab. Litig., 756 F.3d 917, 944 (6th Cir. 2014).

The sum total of all of this is that the question of whether a generics warning label claim could be brought against the brand manufacturer is far from settled in Illinois and the majority of courts to consider Illinois law on the issue have held the state would not recognize the claim.  Given this set of circumstances, the Cipro MDL court had no basis on which to create new Illinois law.  Even if at some time in the future the MDL court turns out to be correct, a notion we loathe to even suggest, the fact is – that is not the law now and that is the only law a federal court sitting in diversity can apply.

Ultimately, the Cipro MDL court placed plaintiff’s claims into two buckets – products liability claims and warning label claims.  While the MDL court was willing to find that the brand manufacturer owed a duty to the generic user, it determined that it was a “limited” liability that only extended to injuries caused by the label.  In re Fluoroquinolone, at *9.    As an aside, it is difficult to understand how an action called “warning label liability” is divorced from or independent of products liability.  The label and its contents are part of the product.  In a failure to warn context, it is the label that plaintiff alleges is defective.  Hence, it is products liability.  Calling a claim that a label is deficient anything else is the worst case of form over substance.  Here again the court chose to ignore the Sixth Circuit which held that warnings claims are in fact products claims.  See In re Darvocet.

This separation of warnings versus products claims gets even more difficult to understand in practice.  Dismissing the breach of warranty claims is straightforward.  They fail for lack of privity.  Id. at *10.  But what about failure to warn claims?  First, the court dismisses plaintiff’s strict liability failure to warn claim because strict liability can only be imposed against an entity in the distributive chain, which the brand manufacturer is not.  Id. at *9.  Then the court dismisses plaintiff’s negligent failure to warn claim because that claim requires “an analysis of the condition of the product.”  Id.  The product plaintiff used is not the one manufactured by the defendant, so that claim is not viable.

The MDL court’s analysis changes when it comes to plaintiff’s fraud and misrepresentation claims.  Here, the court found that plaintiff could pursue these claims against the brand manufacturer based on allegations that the brand label did not contain certain warnings.  But we are left wondering how that differs from plaintiff’s failure to warn claims.  Plaintiff is making the same allegations in each cause of action.  He was not properly warned and as a result he was injured by the drug.  Allowing failure to warn claims to masquerade as fraud and misrepresentation claims just so they can be brought against the brand defendant is a severe distortion of tort law, both generally and in Illinois.



We’re interested in artificial intelligence, particularly as it affects medical devices, but we don’t know all that much about it, and it’s yet to make much of an impact in our product liability sandbox.  Fortunately, we know some folks who do stay informed on this topic, and that’s what today’s guest post is about.  In this post Reed Smith‘s Mildred Segura, Maryanne Woo, and Corinne Fierro, examine the FDA’s most recent activity in this area.  As always our guest posters are 100% responsible for their content, deserving of all the credit (and any blame).


The current state of things has increased nostalgia levels with renewed interest in old TV shows.  They are even rebooting Kate and Allie.  In reviewing FDA’s Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, released last month, the key takeaways harken back to the days of 22 minute, multi-camera programs with catchy theme-songs.  So here’s a little trip in the Wayback Machine (the dog-operated one) to show you what the FDA has in store for future-protecting AI/ML SaMD (i.e. Dr. Theopolis in real life).

Stay Tuned Next Time.  Same Bat Time.  Same Bat Channel.

FDA requested feedback on its 2019 Proposed Regulatory Framework for Modifications to Artificial Intelligence/ Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper (explained in detail here), and clearly many stakeholders picked up the red Bat phone and called in.

The news is that there is much discussion to be had, and we are likely at least two years out from having a final regulatory framework in place.  To get to that finale, FDA set out five goals:

How You Doin’?

FDA’s Predetermined Change Control Plan envisions AI SaMD manufacturers allowing FDA to access real-world performance data of the products so that FDA and manufacturers could continue to monitor the AI as it grew and changed in the field.  While the intention was defined, the details were as ambiguous as the state of Ross and Rachel’s relationship (yes, they were on a break, that doesn’t make it ok to sleep with the copy girl).

One of the issues to be defined is when manufacturers need to report to FDA regarding modifications in the algorithm over time.  The balance to be struck is to avoid Gunther’s bad timing but also to not obsess over every detail like Monica’s 11 categories of towels.

Based upon the comments (and concerns) about how this plan would actually be implemented, FDA’s goal is to publish a Draft Guidance on the Predetermined Change Control Plan at some point in 2021 for commentary.  FDA also indicated it will publish a revamped version of its proposed framework incorporating public feedback, but gave no indication of when it would do so.


FDA’s 2019 Discussion Paper defined the term Good Machine Learning Practice (“GMLP”) as best practices for AI/ML for data management, training, evaluation, documentation, and extraction.  Stakeholders have expressed interest in FDA “harmonizing” efforts to create one norm.  This makes sense, because having a set standard for GMLP is important for guiding the industry and enabling oversight of AI through manufacturer adherence to best practices and standards.  FDA is currently involved in efforts to standardize GMLP, and restated its commitment to do so, just like Norm is committed to Vera.

What ‘chu talking about, Willis?

FDA’s goal of a “patient-centered” approach to the development of AI focuses on transparency to the users and patients in general.  The level of transparency intimated by FDA goes beyond disclosing the risks and benefits of the device  The Action Plan talks about the need for manufacturers to clearly describe the training data, explain why certain inputs were selected, the logic (when possible), the intended role, and proof of concept.  How this is to be accomplished in device labeling requires further discussion.  (What might be right for you, may not be right for some.)  FDA will hold a public workshop to elicit additional community input.  While the goal is to encourage patient trust in AI medical device technology, the responsibilities of the manufacturers to achieve that end is still unclear.

I Don’t Think So. Homey Don’t Play That.

Bias in clinical research has long been documented, especially the overrepresentation of people from European descent and the exclusion of women altogether in clinical trials.  The bias has led to disparate effectiveness in patient outcomes.  Recognizing this issue, FDA reiterated the need for algorithms that are racially and ethnically inclusive and reflective of the patient population.  It is committed to continuing to develop and expand its research partnerships to identify and eliminate bias in machine learning algorithms and ensuring they are robust and resilient enough to withstand changing clinical inputs and conditions.

The Truth Is Out There

Real-World Performance Monitoring (“RWP monitoring”) is the practice of AI designers collecting data on real-world use of their AI so that they may improve products or respond to user concerns.  Currently, manufacturers do not know what data are appropriate to collect, how much data FDA expects to be reported, or how they can use user feedback for improvement.  Going forward, FDA will support RWP monitoring by forming a Mulder and Scully partnership with manufacturers (like Mulder and Scully) on a voluntary basis with the aim of creating a framework for RWP data collection and use.  FDA will also engage the public on this effort.

I Love It When A Plan Comes Together

Long story short, FDA continues to engage with the AI/ML SaMD space, and is deepening its efforts to create a regulatory system that works for manufacturers and the public.  FDA recognizes the importance of this to be done right as it continues to receive a high volume of marketing submissions and pre-submissions for products leveraging AI/ML technologies, which FDA expects to increase over time.  Short story long, a major concern is that technology in the AI/ML SaMD field is developing so rapidly that FDA may never catch up at the rate it is going.  In any event, this space bears watching as it develops as we track the impact it may have on the existing product liability landscape from our custom craft van.