We have become accustomed to doing things remotely these days.  Depositions, court appearances, mediations, conferences, celebrations and family gatherings of all kinds.  The variety of activities that we now do by videoconference pales only by comparison to the speed with which we adapted to this new normal.  We will refrain from opining on whether we are better or worse off compared to a year-and-a-half ago.  We will, however, commiserate with anyone who will listen that our airline loyalty status may never be the same.

Through it all, some things should stay the same—including a court’s power to compel someone to appear in court involuntarily and give testimony under oath before a judge or jury.  Some folks, mainly plaintiffs, would like to use now-familiar videoconferencing technology to extend the subpoena power of federal courts.  We are not so sure, and neither was the district judge who denied requests to allow remote trial testimony in In re Epipen Epinephrine Injection, No. 17-md-2785, 2021 U.S. Dist. LEXIS 125939 (D. Kan. July 7, 2021.

The issue comes down to two Federal Rules of Civil Procedure—Rule 45 governing subpoenas and Rule 43 governing the taking of testimony, including by “contemporaneous transmission from a different location.”  In Epipen, the plaintiffs moved the court to allow trial testimony of the defendant’s former employees by contemporaneous transmission, presumably video conference.

The plaintiffs actually filed two motions.  The first was to allow remote trial testimony by any of the defendants’ current or former employees whom the defendants would not make available in person at trial.  Id. at *29.  Even the most generous reading of the Federal Rules would not permit this sort of blanket ruling, so the court rejected the plaintiffs’ obvious overreach in an informal ruling.  Id. at *29-30.

Which led to the second motion:  The plaintiffs’ motion to allow remote trial testimony from two of the defendants’ former employees, including the former CEO.  Id. at *29-30.  The purported reasoning behind the request was the “tactical” advantage the defendants would gain by refusing to bring their former employees live during the plaintiffs’ case-in-chief.  Id. at *32-33.

Thus Rule 45 and Rule 43 came into play.  Under Rule 45, a court can compel a person to attend a trial “within 100 miles of where the person resides, is employed, or regularly transacts business in person” or “within the state where the person resides etc., if the person (i) is a party or a party’s officer or (ii) is commanded to attend a trial and would not incur substantial expense.”  Id. at *30.  In other words, the court’s trial subpoena power extends 100 miles or, under certain circumstances, to the state borders.

By comparison, Rule 43 governs mode of testimony, which must be taken in open court unless the rules provide otherwise.  Here is the important “otherwise”:

For good cause in compelling circumstances and with appropriate safeguards, the court may permit testimony in open court by contemporaneous transmission from a different location.

Fed. R. Civ. Proc. 43(a).  Before we get back to the Epipen order, we have a few observations about these rules.  Rule 45 defines the scope of a court’s power to command someone to appear against his or her will:  “A subpoena may command a person to attend trial, hearing, or deposition only as follows.”  The conditions that follow define the geographic scope, as we laid out a few sentences ago.  Rule 43 is different in nature.  It specifies not whether a person must testify, but the method by which that testimony must be taken.  On that score, the rule’s exception for remote testimony is exacting on its face—“for good cause in compelling circumstances.”  We often meet good cause requirements.  But without having surveyed every rule, we can say that we much less often see good cause expressly combined with “in compelling circumstances,” let alone further combined with an additional mandate for “appropriate safeguards.”  The drafters of this rule clearly meant business.

And even after laying out these standards, the rule still says the court “may permit” remote testimony.  The court can take it or leave it, unlike Rule 45, which allows the court to command trial attendance only within certain parameters.

How then did this play out in Epipen?  After a thorough survey of orders from other courts, the district court ruled that Rule 43(a) could not be used to circumvent Rule 45’s geographic limits.  Id. at *33-37.  In so ruling, the district court followed the reasoning of a recent order from the District of Wyoming, which ruled that subpoenas for live video testimony under Rule 43 are subject to the same geographic limits as a trial subpoena under Rule 45.  Id. at *36-37 (citing Black Card LLC v. Visa USA Inc., No. 15-cv-27, 2020 WL 9812009 (D. Wyo. Dec. 2, 2020)).  Sure, Rule 43 permits remote video testimony for good cause in compelling circumstances.  But reading that to trump Rule 45 would “render Rule 45(c)’s geographic limitations a nullity and bestow upon any [court] sitting anywhere in the country the unbounded power to compel remote testimony from any person residing anywhere in the country.”  Id. at *36 (quoting Broumand v. Joseph, No. 20-cv-9137, 2021 WL 771387, at *10 (S.D.N.Y. Feb. 27, 2021)).

The Epipen court ruled further that, even if Rule 45’s limits did not apply, it would still deny the motion under a five-factor test laid out in the Vioxx MDL, which courts can apply in exercising their discretion to allow remote testimony under Rule 43.  Critically (and buried unfortunately in a footnote), the Vioxx MDL judge applied this five-factor test only after concluding first that the witness came within the court’s subpoena power under Rule 45.  Id. at *39 n.3.  The power to compel the testimony had to be established before the method of taking it.

We will not enumerate the five Vioxx factors here; you can read them for yourself in the order.  We will say, however, that factor five is the “flexibility needed to manage a complex multi-district litigation.”  Id. at *39.  In response, the district judge in Epipen stated that “the need for flexibility in this MDL doesn’t permit the court to ignore the requirements of the Federal Rules of Civil Procedure.”  Amen.

In the end, this is a sound outcome.  It would be odd if Rule 43 could lift the very clear limitations on trial subpoenas under Rule 45, even under a discretionary showing of good cause in compelling circumstances.  As a practical matter, any “tactical advantage” realized under Rule 45’s geographic limits could apply either way; if anything, the plaintiff would be in a better position to affect those outcomes by selecting a forum where the defendants’ witnesses are most likely employed.  Finally, the court repeatedly noted the practical reality that the Federal Rules already provide a perfectly good solution—the preservation and presentation of testimony through video depositions.  Good order.

A lot of life comes down to timing. Maybe you submitted your job application just as positions were opening. Maybe a slow taxi driver caused you to miss a disaster. Maybe you met the love of your life because an elevator door slammed shut on you.

We’re here to talk about law, not love. Still, there is a lot to love in the SCOTUS Albrecht decision, which breathed new life into conflict preemption of drug failure to warn claims. Initially, we thought the most significant aspect of Albrecht was its insistence that judges, not juries, must decide whether there was “clear evidence” that the FDA would have rejected the warning urged by plaintiffs. But Albrecht has produced progeny and a parade of happy dismissals (well, happy if you are a flint-hearted defense hack), and it is now clear that the real force of Albrecht is the rigorous application of the “new evidence” component of the “Changes Being Effected” (CBE) provision. Was there actual “evidence” warranting a label change (not just a tentative article, not just some adverse event reports) and was it really “new”?

Zamfirova v. AMAG Pharmaceuticals, Inc., 2021 WL 2103287 (D.N.J. May 25, 2021), turned on whether the alleged evidence was “new.” It was about timing. Moreover, the issue of timing was exquisite and the court’s application was rigorous. Zamfirova is a decision that a drug and device defense lawyer should love, though that love will be a little less ardent given that Zamfirova is an unpublished decision.

Zamfirova was a putative class action brought under consumer protection and deceptive practices laws in California, New York, New Jersey, Kansas, Missouri, and Wisconsin. (Good luck coming up with some principle that explains that peculiar collection of states.) The plaintiffs alleged that a medicine marketed to prevent premature births was ineffective. Essentially, the plaintiffs wanted a warning that would say something like, Do not use this drug; it is ineffective. That strikes us as a tiny bit crazy. Here is a very bad fact for the plaintiffs: in 2011 the FDA approved the drug, which means it concluded that the drug was safe and – ta da! – effective.

Did someone say preemption?

Yes, the defendant did, as part of its motion to dismiss the complaint. There was no denying that the plaintiffs were attacking the content of the FDA approved label. In fact, the plaintiffs said that the label itself was “a thicket of misleading half-disclosures and omissions” that was “unquestionably misleading.” So what?

And now we must get to a very good fact for the plaintiffs: a study came out in March 2019 showing no statistically significant difference between the drug and placebo in preventing premature births, and that study prompted an FDA Advisory Committee to recommend that the drug be withdrawn from the market. Insurers then signaled that they would stop paying for the drug. Nevertheless, the manufacturer did not pull the drug from the market.

As we said at the outset, timing is important. The defendant argued that it could not have availed itself of the CBE exception until April 2019 at the earliest, meaning that the plaintiffs’ claims arising before then were preempted. The plaintiff responded that the defendant knew before finalization of the study that incoming data showed ineffectiveness. But that response was mere say-so premised on information and belief. The plaintiffs failed “to allege any specific facts” to support their assertion that the defendant somehow ascertained in advance the results of a double-blinded, placebo-controlled clinical trial. Thus, any claims arising before the final date (March 2019) of the damning study were preempted.

Does that mean that later claims are saved? No, because the plaintiffs failed to allege the specific date on which they were prescribed or they purchased or they took the drug. The plaintiffs simply referenced the “class period,” which would extend from January 2014 to the present. The complaint was vague and overbroad as to time. Because the plaintiffs failed to provide sufficient facts for the court “to determine whether or not their claims are preempted, the Court dismissed all of Plaintiffs’ consumer-fraud based claims….” We’ll get to that ellipsis soon.

The Zamfirova court also dismissed the unjust enrichment claims under New Jersey law because the plaintiffs did not allege that they purchased the medicine directly from the defendant.

About that ellipsis…. The dismissals in Zamfirova were without prejudice. That means the plaintiffs can amend their complaint. Better luck next time. (We say that without a smidgen of sincerity.)

The Xarelto personal injury claims settled in 2019 after six bellwether trials all ended with defense verdicts.  What remained, until now, were several third-party payor (health insurers, “TPPs”) actions that have been dormant for almost six years.  Despite the passage of time, the motions before the court in 2021 were to dismiss under Rules 12(b)(6) and 9(b).    They were granted across the board with causation as the predominant stumbling block.  In re: Xarelto (Rivaroxaban) Products Liability Litigation, 2021 WL 2853069 (E.D. La Jul. 8, 2021).

The TPPs’ claims fall into several buckets:  RICO; fraud, violations of consumer protection laws; redhibition; and unjust enrichment.  Id. at *2.  Under these causes of action, TPPs seek to recover the amounts they paid to fill their patients’ Xarelto prescriptions.  At the core of their allegations, TPPs argue that defendants failed to sufficiently warn of the risks or misrepresented the safety and efficacy of Xarelto to prescribers, the FDA, pharmacy benefit managers (“PBMs”), and the medical community as a whole.  Id. at *3.  PBMs are outside vendors hired by TPPs to review the clinical evidence and prepare a formulary – a list of drugs approved for coverage by the TPPs.  Id.  Therefore, say the TPPs, they are entitled to recover because the PBMs would have not put the drug on formulary if not for defendants’ misrepresentations and they would not have paid for it or would have paid for a less expensive treatment.  Applying the law to the facts, the court found the route between any alleged misrepresentation and the TPPs out of pocket costs to be too circuitous.

The causation element of a RICO claim requires “some direction relation between the injury asserted and the injurious conduct alleged.”  Holmes v. Sec. Inv’r Prot. Corp., 503 U.S. 258, 268 (1992).  Therefore, for proximate cause to exist in a RICO claim, causation must be “straightforward,” with “no independent factors that account for [plaintiffs’] injury,” “no risk of duplicative recoveries,” and “no more immediate victim better suited to sue.”  In re Xarelto, at *4 (citations omitted).  Despite the clear adoption of a “direct relation” requirement by the Supreme Court, in third-party payor actions against pharmaceutical manufacturers there remains a split in the circuits as to whether allegations of misrepresentations to physicians and PBMs meet that requirement.  The Second, Seventh, and Eleventh Circuits say no while the First and Ninth say yes.  The Xarelto decision walks through the precedent on both sides, id. at *5-6, before joining the ranks of the former circuits.

The distinguishing factor appears to be whether the drug manufacturer directly made misrepresentations to the TPP because otherwise intervening factors—such as a physician’s independent medical judgment or a patient’s decisionmaking—interrupt the chain of causation.

Id. at *6 (citation omitted).  Where, as here, the TPPs rely on misrepresentations to doctors, the TPPs are “several levels removed in the causal sequence.”  Id.  In this scenario, it is not clear that the TPPs are the “initially injured” party, let alone the sole injury party.  Id.  The TPPs also attempted to rely on statements made to the PBMs but conspicuously absent from their allegations is any contention that the TPPs made formulary decisions based on any misrepresentations by defendants or that the PBMs were acting as their agents rather than as outside vendors.  Id. at *7.

The reason for the Supreme Court’s “direct relationship” requirement is clear when you consider the impossibility of determining the amount of damages attributable to the alleged misrepresentation as opposed to other independent factors.  And the TPPs focus on the foreseeability of their injury is misplaced.  Foreseeability and directness are two different things.

 Intervening factors, such as the physician or PBM’s independent professional judgment and the patient’s physical condition, medical history, and personal decisionmaking, interrupt the chain of causation and extinguish proximate causation. And these intervening events are not so “readily predictable” that they could be considered the expected consequence of Defendants’ alleged misconduct.

Id. at *8.

After dismissing the RICO claims, the court moved on to common law fraud.  Under any state’s law, a fraud claim requires plaintiffs to plead both a misrepresentation of material fact and reliance on that misrepresentation causing damages.  Id.  On a motion to dismiss, fraud claims are subject to the heightened pleading standard of Rule 9(b) – the fraud must be alleged with particularity to include “the who, what, when, and where.”  Id. at *9.  Defendants argued the TPPs failed this requirement by not alleging the specific physicians or PBMs who received misleading information or how the misrepresentation influenced them to act.  Id.  In response, the TPPs argued that they did not have to identify which specific misrepresentations were made to which specific individuals because defendants “concealed material information from everyone.”  Id. But this type of generalized or fraud on the market causation is insufficient.  There are simply too many unanswered questions.  How many patients would have chosen to take Xarelto even if fully informed of all the risks?  How many doctors would still have prescribed it given an individual patient’s needs and the doctor’s past experience?  In other words, there is no proof, circumstantial or otherwise, that when presented with the warnings the TPPs allege should have been given, the risk benefit analysis undertaken by either the patients or the doctors would have changed.  Id.  This is especially true in a case like this where the drug is still on the market and still being prescribed.  Id.

The TPPs brought claims under the consumer protection laws of Illinois, Louisiana, and New Jersey.  The court concluded that the Illinois and Louisiana claims applied to the TPPs in those states respectively, but that both claims failed.  The Illinois statute requires proof of proximate cause – proof that plaintiff was “actually deceived by the misrepresentation.”  Id. at *11.  As with the RICO claims, the TPPs do not allege that they themselves received any misrepresentation from defendants making any alleged harm “too remote” to survive.  Id.  The claim under the Louisiana Unfair Trade Practices and Consumer Protection Act failed because in Louisiana all products liability claims, except redhibition, are subsumed by the Louisiana Products Liability Act (“LPLA”).  Id. at *12.  The TPPs attempted to argue that their claims were based on defendants’ deceptive marketing rather than on a defect in the product.  But it is undisputed that defendants are manufacturers, that Xarelto is a product, and that the Louisiana legislature made the LPLA the sole remedy for claims involving products.   Id.  at *13.  While the court found no grounds for a consumer protection claim under New Jersey law, that claim also would have failed for lack of causation.  Id.

That left only the redhibition and unjust enrichment claims.  Redhibition claims, however, are only available to buyers of products which the court found the TPPs were not.  The TPPs never take possession of the drug, nor do they pay the full purchase price.  Id. at *14.  Even if considered buyers, redhibition is also only available when a product is considered “so useless” that a buyer would not have bought it had he known of the defect.  Id.  As described above, the TPPs cannot demonstrate “that fewer doctors would have prescribed and fewer patients would have taken Xarelto but for Defendants’ actions.”  Id.  Finally, unjust enrichment is only allowed where there is no other available remedy.  The TPPs have subrogation claims on behalf of their insureds, therefore the unjust enrichment claims must be dismissed.  Id. at *15.

We wanted avocado toast for lunch a week or two ago.  And we had a perfect avocado on the kitchen counter and some nice whole-grain bread in the breadbox.   So we cut the avocado in half, “unscrewed” it to leave the pit in one half, then drove the point of a sharp knife into the pit to remove the pit from the flesh of the avocado.  At least that was the plan.  In what we have learned is such a frequent occurrence that it has gained its own moniker (“avocado hand”) among emergency room personnel, the first half-inch or so of the knife actually ended up embedded about an inch below the middle finger of our left hand.  We were home alone, and we had the (uncharacteristic) presence of mind to apply pressure to our hand and lift it above our head until the (impressive) bleeding slowed.  We then made our way to a local emergency room, where a delightful and efficient nurse practitioner bestowed two stitches upon us, along with enough bandaging for an upper extremity amputation.  All in all, a relative non-event, notwithstanding the war zone we created all over our kitchen.  And we were extremely impressed with treatment – both medical and human – we received at the hospital.  We were in and out in less than an hour, and everyone we met was kind, courteous, and competent.

Maybe that’s why we were attracted to today’s case, in which an appellate court corrected a trial court’s misadventure involving a verdict against a hospital that neither the facts nor the law supported.  In Jackson Hosp. & Clinic, Inc. v. Murphy, 2021 Ala. LEXIS 65 (S. Ct. Ala. June 25, 2021), the plaintiff underwent a ureteroscopy procedure to remove kidney stones.  The procedure involved the use of a “glidewire” to establish the correct path through the urinary tract to the kidneys, where a laser would be used to break up the stones.  The surgery appeared successful, and the plaintiff’s first follow-up visit to the urologist was uneventful, but it was later discovered, when the plaintiff experienced pain and bloody urine, that a piece of the glidewire had been left behind and was lodged in the plaintiff’s bladder.  The plaintiff sued both the urologist who performed the procedure and the hospital where it was performed, asserting claims under the Alabama Medical Liability Act (AMLA).  While the complaint included claims against the hospital for both direct and vicarious liability (based on the doctor’s conduct), the hospital’s counsel confirmed, during a conference on motions in limine, that the plaintiff was pursuing only vicarious liability claims against the hospital, not independent claims under any product liability theory.   (The complaint did not include claims that the hospital had negligently provided a defective glidewire.) During opening statements, the plaintiff’s lawyer stated that the case was about a “defective doctor,” not a “defective product.”  Jackson Hosp., 2021 Ala. LEXIS 65 at *5, asserting that, “when a doctor leaves a foreign object in somebody’s body and that foreign object causes damage, that’s medical malpractice.”  In turn, the defendants’ lawyers stated that the doctor had performed the procedure properly but that the glidewire had broken because it was defective.

The plaintiff’s expert testified that the doctor should have discovered the retained wire fragment during the first follow-up visit and that her failure to do so violated the applicable standard of care.  He also testified, however, that it was standard procedure for hospitals to provide guidewires to doctors in sealed sterile packaging that remained unopened until the doctor was ready to use it, and that the standard of care did not contemplate anyone inspecting the wire before it was used or measuring it after it was used and removed from the patient’s body.

At the close of the plaintiff’s case, both the doctor and the hospital moved for judgment as a matter of law.  The hospital contended that the plaintiff had not proved that any hospital employee had breached any applicable standard of care or had failed to “exercise such reasonable care, skill and diligence as used by similarly situated health care providers.”  Id. at *9.  The hospital also moved for judgment as a matter of law on any claim other than vicarious liability, relying on the parties’ stipulated agreement during pretrial proceedings.  Counsel for the plaintiff argued that the direct liability claim should survive because it was “incredibly unfair for the . . . hospital [which] provided the tool to the doctor to use to say this wasn’t the doctor’s negligence but you also shouldn’t be able to say that we’re responsible because we provided the defective product.”  Id. at *10 (confusing lack of punctuation in original).  Counsel for the plaintiff also stated that he had “gone through and reviewed the complaint” and believed “that the complaint [had] sufficiently preserved the duty of a hospital for a defective instrument.”  Id.  The court denied the hospital’s motion for judgment as a matter of law and “stated its intention to instruct the jury on the potential liability of the hospital.”  Id. at *11.

In its case, the hospital presented the testimony of its own expert, who opined that the hospital was not responsible for the retained glidewire, that the doctor had performed in accordance with the relevant standard of care, and that “the only reasonable explanation [was] that the glidewire was defective.” The expert also confirmed that it was “standard, customary, and usual practice” for glidewires to be delivered to the operating room in sealed packages and for neither the surgeon nor anyone else at the hospital to conduct a formal inspection of the wire before it was used.”  Id. at *12-13.

The judge instructed the jury that, “when a hospital provides instruments or equipment for use in the treatment of patients,  [the] hospital must use that level of reasonable care, skill and diligence as other hospitals use to see that the instruments and equipment are reasonably fit for the normal purposes and uses for which they are intended and furnished.”  Id. at *15.  The jury entered a verdict against the hospital, awarding the plaintiff $100,000 in compensatory damages.  It entered a verdict in favor of the doctor.  The hospital appealed, arguing that the trial court had erred in permitting the plaintiff to proceed on a claim that the hospital had negligently furnished the doctor with a defective product and in instructing the jury on that “claim.”  It also argued that the evidence did not support such a claim, so the court erred in submitting the claim to the jury.

The appellate court explained that, for the plaintiff to prevail on a claim that the hospital negligently provided defective equipment, he was required, under the AMLA, to demonstrate that the hospital breached the applicable standard of care.  Because both the plaintiff’s expert and the hospital’s expert testified that the standard of care did not require the doctor to inspect, test, or measure the glidewire before or after it was use and did not require the hospital to undertake more responsibility in this regard than the doctor did.   Because the plaintiff had not presented evidence that the hospital breached the standard of care, the jury’s verdict was “unsupported,” id. at *21, and the court reversed it.

We think the court missed the boat a little bit, though it took a water taxi and arrived back at the correct spot.  Given the fact that the complaint did not include a claim that the hospital negligently provided a defective product to the doctor, and also the fact that the parties had stipulated that only vicarious liability was being pursued against the hospital, the court did not need to analyze the evidence:  it could and should have reversed the verdict on purely legal grounds.

But all’s well that ends well.  Same for our hand, by the way.  It’s all healed up, and the scar is all but invisible.  And the numbness in our middle finger is receding.  We have a yen for avocado toast, again, and we have a new “pit removal tool” sent by the Drug and Device Law Rock Climber.

We’ll be in touch with other notable decisions, good and bad.  In the meantime, stay safe out there.

With apologies to Harry Kalas.

Bexis had a couple of encounters with the “Wayback Machine” (a/k/a/ the “Internet Archive”) recently.  If you don’t know what that is, it’s digital library of Internet ephemera – web pages and the like − that have since been taken down, revised, or otherwise have become unavailable in their original locations (it contains other material, as well, like old books).  Researching Bexis’ recent off-label use law review article entailed searches for long-since vanished FDA material.  Even more recently, Bexis advised someone looking for a 40-year-old “Dear Doctor” letter to try the Wayback Machine, since the drug in question had undoubtedly gone generic, and the manufacturer probably didn’t maintain a website for that drug.

That got us (well, Bexis) thinking.  Are documents and other information obtained from the Wayback Machine admissible in court?  If so, how have they been used?

The answer to the first question appears to be yes, although it can take some doing.  The answer to the second question is “lots of different ways.”  We discuss some of them in this post.

Starting with admissibility, in a criminal case, Wayback Machine material from the defendant’s now-defunct website was held admissible where the Wayback Machine screenshots were authenticated by:

a witness [who] testif[ied] about how the Wayback Machine website works and how reliable its contents are.  The witness also compared the screenshots with previously authenticated and admitted images from [defendant’s] website and concluded, based upon her personal knowledge, that the screenshots were authentic.

United States v. Bansal, 663 F.3d 634, 668 (3d Cir. 2011).

In another criminal case, the prosecution actually “presented testimony from the office manager of the Internet Archive, who explained how the Archive captures and preserves evidence of the contents of the internet at a given time.”  United States v. Gasperini, 894 F.3d 482, 490 (2d Cir. 2018).  As in Bansal, that witness also “also compared the screenshots sought to be admitted with true and accurate copies of the same websites maintained in the Internet Archive, and testified that the screenshots were authentic and accurate.”  Id.  Agreeing with Bansal, Gasperini likewise found the evidence properly admitted.

We agree with the holding of the court in Bansal, and hold that the testimony presented in this case by the government was sufficient proof that a reasonable juror could find in favor of authenticity or identification.  [Defendant] was free to cross-examine the witness about the nature and reliability of the Archive’s procedures for capturing and cataloging the contents of the internet at particular times, and the jury was thus enabled to make its own decision about the weight, if any, to be given to the records.

Id. (citation and quotation marks omitted).  See United States v. Kieffer, 681 F.3d 1143, 1154 n.3 (10th Cir. 2012) (holding Wayback Machine downloads properly authenticated); Mojave Desert Holdings, LLC v. Crocs, Inc., 844 F. Appx. 343, 346 (Fed. Cir. 2021) (relying on patent examiner’s analysis of “a collection of web pages” downloaded from the Wayback Machine).

Indeed, courts “routinely take judicial notice . . . of the Internet Archive’s Wayback Machine as reliable evidence of how a particular website appeared on a particular date.”  Munn v. Hotchkiss School, 165 A.3d 1167, 1203 (Conn. 2017) (citing Perera v. Attorney General, 536 F. Appx. 240, 242 n.3 (3d Cir. 2013); Distributorsoutlet.com, LLC v. Glasstree, Inc., 2016 WL 3248310, at *2 (E.D.N.Y. June 10, 2016); Erickson v. Nebraska Machinery Co., 2015 WL 4089849, at *1 n.1 (N.D. Cal. July 6, 2015); Pond Guy, Inc. v. Aquascape Designs, Inc., 2014 WL 2863871, *4 (E.D. Mich. June 24, 2014)).

For other appellate cases judicially noticing Wayback Machine material, or treating it as authoritative without mentioning judicial notice, see Monster Energy Co. v. City Beverages, LLC, 940 F.3d 1130, 1140 (9th Cir. 2019) (citing Wayback Machine material – apparently researched independently by the court – for when certain material was available on a particular website); Arteaga v. United States, 711 F.3d 828, 834 (7th Cir. 2013) (treating Wayback Machine material from government website as authoritative); Khan v. Bank of New York Mellon, 525 F. Appx. 778, 780 (10th Cir. 2013) (taking judicial notice of governmental material from Wayback Machine); Motor Vehicle Administration v. Geppert, 233 A.3d 102, 111 n.15 (Md. 2020) (relying on Wayback Machine material that the appellant left repealed regulations on its website for years); State v. Ramseur, 843 S.E.2d 106, 116 nn.7-8 (N.C. 2020) (treating Wayback Machine material as authoritative legislative history); Snow v. Snow, 68 N.E.3d 1138, 1145 (Mass. 2017) (same); Ennabe v. Manosa, 319 P.3d 201, 214 n.15 (Cal. 2014) (treating as authoritative Wayback Machine copy of administrative materials that were “never reduced to hardcopy and existed as an online resource”); Irwin v. Commonwealth, 992 N.E.2d 275, 285 (Mass. 2013) (treating Wayback Machine material as authoritative legislative history); State v. Hutchings, 285 P.3d 1183, 1192 (Utah 2012) (using Wayback Machine material to establish date that a new jury instruction became available); Burts v. Burts, 266 P.3d 337, 340 n.5 (Alaska 2011) (treating Wayback Machine material as authoritative regulatory history); Cardona v. Kreamer, 235 P.3d 1026, 1029 n.3 (Ariz. 2010) (treating federal government Wayback Machine material as authoritative).  Contra Juniper Networks, Inc. v. Shipley, 394 F. Appx. 713, 713 (Fed. Cir. 2010) (denying motion to take judicial notice of Wayback Machine material for the first time on appeal).

There appear to be about 200 trial level judicial decisions citing to Wayback Machine materials.  We decided to look for materials of particular interest to our readers, so we narrowed our search by adding drug/device related search terms.  Judicial notice of Wayback Machine evidence resulted in dismissal of a food-related consumer fraud claim in Cosgrove v. Oregon Chai, Inc., ___ F. Supp.3d ___, 2021 WL 706227 (S.D.N.Y. Feb. 21, 2021).  After taking judicial notice of Wayback Machine excerpts from the defendant’s website, Cosgrove found no actionable misrepresentation:

On the theory that the provision of different flavors . . . products may have been of recent vintage, the Court also examined archival copies of Defendant’s website using the Internet Archive Wayback Machine. . . .  [C]ourts have taken judicial notice of the contents of web pages available through the Wayback Machine as facts that can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned under Federal Rule of Evidence 201. . . .  [Under Rule 201, t]he parties may submit a letter limited to this issue within 14 days.

Id. at *12 n.5 (citations and quotation marks omitted) (Rule 201 governs judicial notice).

United States ex rel. Oliver v. Philip Morris USA, Inc., 101 F. Supp.3d 111 (D.D.C. 2015), aff’d, 826 F.3d 466 (D.C. Cir. 2016), was a False Claims Act case.  The Wayback Machine came in handy for the defendant, which searched it to establish that the plaintiff/relator’s allegations were, in fact, public knowledge prior to the suit:

Defendant has submitted new evidence purporting to show that the [disputed] requirements were publicly available throughout the period when Oliver alleges that the fraud occurred. . . .  Defendant searched the Internet Archive, a website that offers permanent access for researchers, historians, scholars, people with disabilities, and the general public to historical collections that exist in digital format[, and]. found “archived pages . . . linking to copies of [the disputed materials] that contain the [contract] provisions at the heart of this case.

Id. at 117 (citations quotation marks, and footnote omitted).  The court found the material “authentic”:

The Court has carefully examined the webpages and is confident that the pertinent language is on the webpages themselves and is not embedded in any image file. . . .  Defendant has submitted to the Court the actual archived webpages.  That relevant language on those webpages is visible without clicking on any links.  The Court is confident that it is examining the archived websites and not the live web. . . .  In light of the above, the Court concludes Defendant has submitted sufficient evidence to support a finding that the archived webpages are authentic.

Idaida 122-23 (citations omitted).  On the strength of this information, Oliver was dismissed under the FCA’s “public disclosure” jurisdictional bar.  Id. at 123-24.  See United States ex rel. Kester v. Novartis Pharmaceuticals Corp., 43 F. Supp.3d 332, 349 (S.D.N.Y. 2014) (similar successful use of Wayback Machine materials to establish public disclosure bar).

In United States v. Shrum, 2011 WL 1753488 (E.D. Ark. May 9, 2011), the FDA Office of Criminal Investigations used the Wayback Machine to investigate “Canadian” Internet pharmacies.

This tool allegedly enabled the agent to obtain a screen-shot depicting a pharmacy web-site as it appeared on a specific date in the past.  The Court admitted the testimony and images of the pharmacy web-site which depicted a statement at the bottom of the image noting that the FDA did not approve of purchases from this web-site.

Id. at *1.  The material was ultimately excluded as hearsay, but armed with this information, the government was able to use live witness testimony “about the banner” and obtained a conviction.  Id. at *2.

In Schilf v. Eli Lilly & Co., 2010 WL 3909909 (D.S.D. Sept. 30, 2010), plaintiffs sought to authenticate Wayback Machine historical drug labeling through “the office manager for Internet Archive,” but failed to include this individual on their witness list.  That failure resulted in preclusion of the witness, although “Defendants d[id] not object to the documents” themselves.  Id. at *5.  See also Medscript Pharmacy, LLC v. D&D Pharma LTC, LLC, 444 F. Supp.3d 909, 911-12 (N.D. Ill. 2020) (defendant obtained summary judgment using Wayback Machine materials to show prior use in dispute over prescription drug plan trademarks), Colella v. Atkins Nutritionals, Inc., 348 F. Supp.3d 120, 121 n.2 (E.D.N.Y. 2018) (plaintiff relied on Wayback Machine regarding certain nutritional claims allegedly made by manufacturer but “removed after litigation commenced”; case dismissed for lack of FDCA “net carb” violation); Moorer v. Stemgenex Medical Group, Inc., 2017 WL 1281882, at *5 (S.D. Cal. April 6, 2017) (plaintiffs’ “attachment of Defendants’ archived [in the Wayback Machine] webpages is necessary, especially here where the parties disagree over the significance of the patient satisfaction reports”; utilizing incorporation doctrine on motion to dismiss consumer protection claim); Tompkins v. 23andMe, Inc., No. 5:13-CV-05682-LHK, 2014 WL 2903752, at *1 n.1 (N.D. Cal. June 25, 2014) (judicial notice of Wayback Machine materials establishing content of defendant’s website on date of FDA warning letter), aff’d, 840 F.3d 1016 (9th Cir. 2016); Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc., 2012 WL 3133943, at *2 (Mag. D.N.J. July 30, 2012) (use of Wayback Machine materials to prove prior art in generic drug patent litigation; motion to amend denied as prejudicial; granting motion to compel arbitration), aff’d, 2013 WL 785067 (D.N.J. Feb. 28, 2013); In re Hydroxycut Marketing & Sales Practices Litigation, 810 F. Supp.2d 1100, 1114 n.4 (S.D. Cal. 2011) (use of Wayback Machine materials to establish dietary supplement company’s use of certain website names at relevant times).

Lawyers do have to do their homework, however.  Wayback Machine materials without sufficient authentication have been disregarded.  See ATEN International Co. v. Uniclass Technology Co., 932 F.3d 1364, 1368 (Fed. Cir. 2019) (Wayback Machine material that was merely in the “same year” as the “critical date” could not support jury verdict); Dillon v. NICA, Inc., 2011 WL 6296729, at *6 (Tenn. App. Dec. 14, 2011) (witness “could not satisfy the authenticity requirement relative to the entirety of the [86-page] exhibit as proposed for admission”); McFall v. Perrigo Co., 2021 WL 2327936, at *3 (C.D. Cal. April 15, 2021) (defendant “did not authenticate [Wayback Machine material], and the court has no basis to find that this document was obtained from a government website or is what Defendants claim it to be”); Hsu v. Puma Biotechnology, Inc., 213 F. Supp. 3d 1275, 1284 (C.D. Cal. 2016) (refusing to consider Wayback Machine material because it was extrinsic evidence on a motion to dismiss introduced “for the first time in a reply brief”).

Thus, Internet-archived material obtained through the Wayback Machine is, if properly authenticated, admissible in court – subject to any other generally applicable requirements.  Its potential uses seem to be limited only by the imagination of counsel, so the Wayback Machine is definitely something that defense counsel should keep in mind.

It has been a while since we saw a movie in a theater.  That is one aspect of the oft-discussed return to normality that appeals to us.  When we saw a trailer recently for The Many Saints of Newark, a prequel to old HBO mainstay The Sopranos, it piqued our interest.  It even made us return to the original series, which began more than twenty years ago, something we knew but still have a little trouble grasping.  The mobsters who are the focus of the show are constantly looking for new schemes to make money with the specter of RICO and FBI wiretaps, subpoenas, and informants never far from their minds.  When Junior Soprano is arrested in season 1, Tony is aware of the RICO predicates charged in the indictment.  As various criminal plans are hatched, the hatchers look for intermediaries, civilian and otherwise, to keep the higher ups further away from the actual crime if things go south.  You get the idea.

We are not saying plaintiff lawyers are like mobsters, but they do tend to come up with creative claims and theories in attempts to impose liability on as many defendants as possible even when they might have strong claims against one or more logical defendants.  We see this dynamic in one of the recent orders from the Zantac MDL, where plaintiffs have asserted many claims against many defendants in what seems to be at its core a litigation over alleged injuries from an alleged carcinogen, NMDA, in prescription and over-the-counter medications.  We have discussed a number of decisions, mostly good, from this MDL over the last several months.  In In re Zantac (Ranitidine) Products Liability Litigation, MDL No. 2924, 2021 WL 2685640 (S.D. Fla. June 30, 2021), the court addressed the OTC manufacturer defendants’ motion to dismiss the civil RICO claims asserted against them in the current complaint.  Why RICO when traditional product liability theories might do?  Well, the statute does provide a winning plaintiff with “threefold the damages he sustains and the cost of the suit, including a reasonable attorney’s fee.”  That would be why.  A more interesting question might be “how RICO.”  That is what the court addressed in what seems to us like a strong decision.

The specifics of the claims are that a bunch of purported class representatives claim to have purchased OTC Zantac and allege that the OTC manufacturers violated 18 U.S.C. § 1962(c) by “engag[ing] in . . . a pattern of racketeering activity or collection of unlawful debt” and/or conspired with each other to do so under §1962(d).  Id. at *3.  The alleged “racketeering activity” consisted of “an enterprise to deliberately and unlawfully misrepresent the safety risks” of the drug though a “decades-long marketing and promotional campaign to mislead the public,” “misleading communications with federal regulators,” and “efforts to manipulate key opinion leaders and industry groups.”  Id.  Defendants raised a number of arguments about plaintiffs’ failure to plead the elements of a RICO claim, but the court only had to decide one:  whether plaintiffs could sue as indirect purchasers of defendants’ medication given that they did not allege any direct purchases from defendants.

Unlike some of the really bad decisions in the third party payor context that have allowed RICO claims to proceed (see here and internal links), the plaintiffs here all claimed to have paid third party retailers like pharmacies and grocery stores for the drugs they purchased.  Defendants’ argument was fairly straightforward and grounded in multiple Supreme Court decisions.  They contended RICO prohibits recovery by indirect purchasers because its language focuses on direct purchasers and that language was modeled on federal antitrust law, which clearly prohibits recovery by indirect purchasers.  Id. at *4.

The rationales for barring indirect purchaser suits are:  (1) facilitating more effective enforcement of antitrust laws; (2) avoiding complicated damages calculations; and (3) eliminating duplicative damages against antitrust defendants.

Id. at *5 (internal citation omitted).  The majority of federal courts to consider the application of the indirect purchaser rule to civil RICO claims, including three circuit courts and a decision from the Southern District of Florida earlier this year, followed the same rationale.  Id. at *6.

Plaintiffs did not accede to the majority position without a fight.  They argued that a 1985 Supreme Court decision somehow trumped the 1992 Supreme Court decision endorsing antitrust principles for the interpretation of RICO’s language.  They also argued that language in an Eleventh Circuit decision from 1988 that there are “perils in relying too closely on the analogy of the antitrust laws” weighed against adopting the indirect purchaser rule.  Id. at *7.  Neither worked.  Then they claimed that RICO standing could be established based solely on allegations of proximate cause, citing another 1988 Eleventh Circuit case that involved direct purchasers.  “Because the Supreme Court’s message in Holmes [the 1992 case] was clear, the Court is persuaded to join the prevailing view that the indirect purchaser rule applies to RICO claims.”  Id.

Because plaintiffs “were not the first, nor even the second, purchasers in the OTC distribution chain,” the dismissal of their claims in the face of the adoption of the indirect purchaser rule was clear.  Id.at *8.  Yet, they offered a creative argument for the creation of an exception to the indirect purchaser rule for those who allegedly suffered “direct harm” or were the “first victims” of the alleged RICO scheme.  Although creative, this too had been addressed and rejected by a circuit court.  Id. at **8-9 (citing Warren Gen. Hosp. v. Amgen Inc., 643 F.3d 77, 92 (3d Cir. 2011)).  Thus, the indirect purchaser rule was an “unsurmountable hurdle for Plaintiffs” and their RICO claims were dismissed with prejudice.  Id. at *9.  With that, we will resist the urge to make any analogies to real or fictional mobsters and simply say that the ruling seems to us like another step in eliminating frivolous, but dangerous, civil RICO claims from product liability litigation against drug manufacturers.

It is time for our quarterly report on doings in the Nolen IVC case in the Middle District of Tennessee. Last April, we discussed a decision in the Nolen case that was rather bad on failure to warn and rather good on punitive damages. This time, in Nolen v. C.R. Bard, 2021 U.S. Dist. LEXIS 99206 (M.D. Tenn. May 26, 2021), the news is all good.

Before we explore the latest ruling, please enjoy this quick refresher on the Nolen case. A filter was implanted in the plaintiff’s inferior vena cava (IVC) on July 12, 2012. The purpose of the filter was to intercept blood clots that might cause deep vein thrombosis, which is bad, or a pulmonary embolism, which is very bad. The filter got stuck in the IVC, which the plaintiff believed was bad enough to warrant a lawsuit for failure to warn and product defect.

At issue in this most recent opinion in Nolen was the defendant’s motion in limine to exclude evidence that “arose” after the implantation date because such evidence had no bearing on either the design of the filter or any failure to warn. This sort of motion in limine is common. Plaintiffs want to measure a product against perfection, including perfect knowledge that did not exist when the product was used. It is an unfair standard. Have you ever heard President Biden say he wants to be compared “to the alternative, not the Almighty”? We burn a lot of calories at trial asking jurors the same thing on behalf of our clients.

Nolen was governed by the Tennessee Products Liability Act (TPLA), which contains uncommon good sense on this issue. The TPLA looks to whether a product was defective “at the time it left the control of the manufacturer or seller.” Pretty ordinary stuff, right? But wait, it gets better. The TPLA goes on to say that, “[i]n making that determination, the state of scientific and technological knowledge available to the manufacturer or seller at the time the product was placed on the market, rather than at the time of injury, is applicable.” Tenn. Code Ann. section 29-28-105(b). New information after sale of the product is simply too late.

There was skirmishing between the parties in Nolen as to whether there could be a post-sale duty to warn. No Tennessee court has recognized such a post-sale duty to warn. The plaintiff grabbed hold of a Sixth Circuit case — Fox v. Amazon.com, Inc., 930 F.3d 415, 427 (6th Cir. 2019)- interpreting Tennessee law to recognize a narrow claim based on an assumed duty to warn arising after the defendant had already sent one warning on which the consumer relied. Fox was really about a duty to update a warning. And even that was a bone tossed to plaintiffs to make up for the court’s ruling that Amazon was not a seller.

Be that as it may, should Fox inspire a broader post-sale duty to warn? Nope. First, that is a bad rule. How do you think such a rule affects incentives for issuing voluntary post-sale warnings? Second, nothing like that voluntary undertaking occurred in Nolen. Third, the Nolen court followed Erie modesty and declined to predict that the Tennessee Supreme Court would expand upon the Sixth Circuit’s voluntary undertaking theory to create a broad post-sale duty to warn. Whew!

All that being said, the Nolen court refused to say that there could never-ever be post-sale evidence that might be probative. Just as a photograph of a building on Friday might at least suggest the building existed on the prior Monday, there could conceivably be post-sale evidence (of a draft warning, for example) that might demonstrate pre-sale knowledge. (Yes, that is kind of a batty analogy, but it is the one used by the court.) But the plaintiff would need to offer something specific and nonspeculative to make that case. Accordingly, the Nolen court granted the defendant’s motion in limine and ordered the plaintiff not to introduce post-sale evidence without first satisfying the court that an adequate foundation exists.

The good news is that there will likely be no post-sale evidence that passes muster. The bad news is that by keeping the door open a crack, the Nolen decision is of only limited utility in arguing that post-sale evidence should not even be discoverable in the first place.

Recently, in the context of an IVC filter case, the Third Circuit Court of Appeals certified two questions to the Pennsylvania Supreme Court:

1. Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may the plaintiff also prevail on other theories of liability where appropriate?

2. Under Pennsylvania law, are prescription implantable medical devices categorically subject to strict liability, categorically immune from strict liability, or immune from strict liability on a case-by-case basis? If they are immune on a case-by-case basis, what test should a court apply to determine whether a particular device is immune?

Petition for Certification of Questions of State Law, Ebert v. C.R. Bard, Inc., 2021 WL 2656690, at *6 (3d Cir. June 24, 2021).

The first question concerns the scope of the novel “negligent design” claim allowed in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), see our post here about Lance.  The Third Circuit asks whether the Lance cause of action is limited to the relatively unusual unsafe-for-any-class-of-patients claim that the Pennsylvania Supreme Court actually allowed in Lance (as bad as that was), or if will it metastasize into a general negligent design claim.  This assumes – something that is not at issue in either Lance or Ebert – that design defect claims of this sort are not impliedly preempted by the need for prior FDA approval of design changes under the Mensing independence principle (see our post here).

The second question is whether Pennsylvania will adhere to 75 years of Pennsylvania Supreme Court precedent rejecting strict liability in drug and medical device product liability litigation.  See Lance, 85 A.3d at 452-53; Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996); Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 527 (Pa. 1995); Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385-86 (Pa. 1991); Baldino v. Castagna, 478 A.2d 807, 810 (Pa. 1984); Incollingo v. Ewing, 282 A.2d 206, 219-20 (Pa. 1971); DiBelardino v. Lemmon Pharmacal Co., 208 A.2d 283, 283 (Pa. 1965); Henderson v. National Drug Co., 23 A.2d 743, 748 (Pa. 1942).

We discussed that precedent (and much more) at length in response to the first federal district court case to claim that a non-prescription medical product case, Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), somehow changed that rule, although it was never before the Tincher court.  We have since chronicled additional precedent, almost all of it federal, good and bad, over the last couple of years.  That includes the district court decision in Ebert.  Now the issue is finally before the court that under our federal system, is supposed decide it.

Some background on this second issue.  The Tincher decision, which we discussed here and here, overturned Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978), and with it – we hoped – 35 years of pro-plaintiff Pennsylvania idiosyncrasy that had removed the issue of whether a product defect was “unreasonably dangerous” under Restatement §402A from the jury’s purview on the now-discredited proposition that negligence and strict liability were absolutely separate and that evidence of negligence was improper in a case raising only strict liability.  This led to an appalling “manufacturer as guarantor” jury instruction, refusal to charge the jury on risk/utility principles, abolition of the state-of-the-art defense so that liability could be based on scientifically unknown risks, as well as depriving the jury of relevant evidence, such as concerning compliance with governmental and industry standards, plaintiff comparative fault, and exclusion “reasonableness” and “foreseeability” generally (at least when these would have benefited a defendant).

The effect of the existing no-strict liability rule in the Hahn/Incollingo line of cases was to insulate our sandbox – prescription medical product liability litigation in Pennsylvania – from the jurisprudential depredations of the Azzarello era of super-strict liability.  We were never faced with arguments by plaintiffs that any dichotomy between negligence and strict liability meant that, say, the compliance of a drug or device with FDA requirements was “irrelevant” in strict liability and could not be made known to the jury.  Nor were our clients subjected to strict liability-based arguments that they could be liable for alleged product risks that were not scientifically discovered until much later.

But at the same time that the Ebert action was pending in the Third Circuit, the Pennsylvania Superior Court – in a non-prescription medical product decision − decided to reinsert some of the worst of the Azzarello-era product liability restrictions on admissible evidence into the new Tincher regime.  See Sullivan v. Werner Co., ___ A.3d ___, 2021 WL 1419480 (Pa. Super. April 15, 2021), reargument denied (June 23, 2021):

Under the above-quoted provision [Restatement (Second) of Torts §402A(2)(a) (1965)], it is irrelevant if a product is designed with all possible care, including whether it has complied with all industry and governmental standards, because the manufacturer is still liable if the product is unsafe.

Id. at *12.  Denial of reargument in Sullivan occurred the day before the Third Circuit’s Ebert certification of the strict liability question to the Pennsylvania Supreme Court.  Assuming Sullivan is appealed, that means that both questions will simultaneously be before the Pennsylvania Supreme Court.

To us, the potential synergy between Ebert, on the strict liability question, and Sullivan, on the inadmissibility of government and industry standards in strict liability, raises the stakes in both appeals considerably.  Anyone involved in pelvic mesh litigation knows how exclusion of FDA compliance evidence there has created an FDA-free fantasy world that misleads juries and has allowed plaintiffs free reign to make arguments at odds with what the FDA required.  Imagine having to deal with a similar situation in every future drug and device case in Pennsylvania.

That’s what is now at stake.

We don’t know much, but there are a few things we know for sure.  One is that when a topic is complex and not within the knowledge of an ordinary lay person, you generally need an expert.  A second is that determining the medical cause of a disease is almost always complex and not within ordinary knowledge.  A third is that any attorney who has ever filed a personal injury case knows for pretty darned sure that he or she is going to need experts, especially in cases involving drugs and medical devices.

It therefore astounds us when plaintiffs attempt to proceed in drug and device cases without experts, because it just does not work.  Take, for example, the order granting summary judgment in Vicknair v. Pfizer, Inc., No. 20-2705, 2021 U.S. Dist. LEXIS 115962 (E.D. La. June 22, 2021).  The plaintiff was treated with an intravenous antibiotic manufactured by the defendants and allegedly experienced chills, tremors, fever, shortness of breath, and disorientation.  According to the complaint, the defendants voluntarily recalled particular lots of the antibiotic four months later, allegedly in response to reports of similar reactions.  Id. at *2.

We obviously have no idea whether the plaintiff’s subsequent lawsuit against the drug manufacturers had any arguable merit.  We do know, however, that when the plaintiff is 71 years old, had been treated for a preexisting infection, suffered from multiple medical problems, had recently undergone two invasive procedures, and was taking several other prescription medications [id. at *8-*9], he was going to need an expert on medical causation.  Maybe multiple experts.

Which makes the plaintiff’s conduct very curious.  “When the issue of medical causation is complex and not within the knowledge of an ordinary lay person, both the Fifth Circuit and the Louisiana Supreme Court hold that plaintiff must submit expert testimony to prove causation.”  Id. at *5.  This standard is common, yet the plaintiff in Vicknair did not disclose a medical causation expert.  Nor did the plaintiff contend that he even needed to disclose a retained expert, because he purportedly intended to rely instead on testimony from his treating physician.  Id. at *6.

The problem with that plan was that the plaintiff did not serve an expert disclosure identifying the treating physician either.  The plaintiff opposed summary judgment with a letter from his treating physician that stated “the content of the testimony he hopes to introduce,” but that was nearly two months after the expert disclosure deadline.  Id. at *6-*7.  The plaintiff did not even request leave to make a late disclosure, which at least might have given him a chance.  The court excluded the letter as untimely.  Id. at *7.

The plaintiff took the path of least resistance, but also the path least likely to succeed:  He argued that medical causation in his case was not complex and could be proved without expert testimony.  More specifically, he argued that “causation can be established based on his medical records and the fact of defendants’ voluntary recall.”  Id. at *8.  The district court rejected that proposition out of hand:  “The question whether an intravenous antibiotic was the cause of the plaintiff’s symptoms is plainly ‘complex and not within the knowledge of an ordinary lay person.’”  Id. at *8.  The plaintiff needed an expert, and while he argued that he had produced medical records well in advance of the expert deadline, “disclosures consisting of medical records alone are insufficient to satisfy the [expert] disclosure standard of Rule 26(a)(2)(C).”  Id. at *9.

This plaintiff banked on a voluntary recall to carry the day, and he correctly was left holding the bag.  As we have written multiple times, including here, a product recall does not equal a product defect.  A recall does not even come close to proving medical causation on any level, yet this plaintiff challenged the court to allow that inference.  The court refused and invoked a rule on medical causation and expert opinion that applies most everywhere.  Again, we don’t know much, but we know enough to say that this was the correct outcome.

To bring suit in federal court, a plaintiff must have “Article III standing.” That is to say, the plaintiff must have a personal stake in the suit’s outcome. This is true whether a plaintiff is suing individually or as a member of a class.

Late last week, in TransUnion v. Ramirez, — S. Ct. —-, 2021 WL 2599472 (U.S. 2021), the Supreme Court held that even if a federal statute creates a private right of action authorizing individuals to sue violators for actual or statutory damages, a plaintiff may not bring such an action in federal court unless they allege—and ultimately prove—that they suffered actual harm from a statutory violation. That a violation creates a risk of future harm is, the Court held, insufficient to confer Article III standing on a plaintiff and thus insufficient to establish federal jurisdiction over a plaintiff’s claim.

Although decided under the Fair Credit Reporting Act (FCRA), the TransUnion decision could have far-reaching implications. By preventing plaintiffs without actual damages from seeking statutory damages in federal court, the decision will likely reduce the number of federal suits—particularly class actions—that seek statutory damages under a variety of statutes. But, because the decision does not prevent such plaintiffs from seeking such damages in state court, the decision might simply divert suits from federal to state courts.

While suits seeking to impose liability for conduct that has caused no actual harm are more common in other industries, the pharmaceutical and medical-device sectors are not immune from such claims, whether in the form of medical-monitoring claims brought by individuals or consumer-protection claims brought by state officials. TransUnion will likely forestall at least some of those suits from being brought in federal court. Unless would-be plaintiffs are able to demonstrate that “the risk of future harm itself causes a separate concrete harm” (TransUnion, 2021 WL 2599472, at *13), the decision should keep medical-monitoring claims out of federal court. Its effect on state regulatory actions, however, will probably be minimal, both because state regulators tend to sue in state court and because governments are generally held to have standing to enforce their laws.

In TransUnion, over eight-thousand plaintiffs brought a class action alleging that the defendant credit reporting agency had violated the FCRA when it created credit reports misleadingly identifying each plaintiff as a “potential match” to someone on a government-maintained list of terrorists, drug traffickers, and other serious criminals. According to the plaintiffs, the defendant breached the FCRA by failing to use reasonable procedures when identifying the plaintiffs as potential matches to persons on the list, by failing to provide upon request complete copies of the plaintiffs’ respective credit reports, and by failing to supply mandated information in the mandated form when responding to the plaintiffs’ requests for their credit reports.

Citing its 2016 Spokeo decision, the Court held that class members whose misleading credit reports had been disseminated by the defendant to third parties had standing to seek statutory damages for the defendant’s violation of the FCRA’s reasonable-procedures requirement because these plaintiffs could establish a “concrete injury” analogous to one recognized at common law, namely, defamation. Conversely, the Court held that class members whose misleading credit reports had not been disseminated did not have standing, even if the defendant had failed to use reasonable procedures when preparing their credit reports, because these plaintiffs were unable to show such an injury.

In concluding that plaintiffs in the second category were unable to establish a concrete injury and thus unable to establish standing, the Court acknowledged that the defendant’s statutory violation placed the plaintiffs at risk of future harm but rejected the contention that the risk of such harm is sufficient to confer standing. While Spokeo recognized that “the risk of real harm” could constitute a concrete harm for purposes of standing, the TransUnion Court distinguished between claims for statutory damages and claims for injunctive relief, holding that a risk of future harm could establish Article III standing, and thus federal jurisdiction, over claims for injunctive relief but not over claims for statutory damages.

In what the four dissenting justices viewed as an irony, the Court invoked the separation-of-powers doctrine to justify its conclusion that an individual cannot sue for statutory damages absent actual injury even if Congress creates a private right of action authorizing such actions. According to the majority, requiring plaintiffs to demonstrate “concrete injury” to establish standing to sue ensures that “[f]ederal courts do not exercise general legal oversight of the Legislative and Executive branches, or of private entities.” Allowing private plaintiffs to sue for statutory violations absent concrete, particularized injury would, said the Court, undermine the executive agencies’ regulatory and prosecutorial discretion. And while Congress can create causes of action for “concrete, de facto injuries” for which there previously was no remedy, it may not, said the Court, “simply enact an injury into existence, using its lawmaking power to transform something that is not remotely harmful into something that is.”

The majority’s reasoning provoked an originalist dissent from Justice Thomas, who in an unusual alignment was joined by the Court’s three liberal members. According to the dissent, Article III standing was always a matter of whether a plaintiff pressed his or her own private rights and was a barrier only to citizen-suits pressing rights held by the public at large. The dissent accused the majority of inventing the idea that a violation of a statutory right might not be an injury in fact sufficient to support standing, using as an example copyright law, which creates new rights and permits plaintiffs to sue in federal court for injuries that exist only in law.

The dissent also noted an important limit to the Court’s decision, which affects only federal court jurisdiction under Article III. It does not bind state courts, and some states have rejected various aspects of federal standing jurisprudence. It is not clear how the Supreme Court’s statement about Congress’s inability to enact an injury into existence for purposes of Article III will affect a state court’s concurrent jurisdiction to hear cases arising under federal law. The dissent argued that the Court may have ensured that state courts will have exclusive jurisdiction over this sort of class actions. Although litigants cannot confer federal subject-matter jurisdiction where it does not exist and federal courts are required to examine sua sponte whether they possess subject-matter jurisdiction, arguing that a plaintiff lacks Article III standing in a borderline case could force the defendant to litigate in state court. Defendants considering seeking dismissal based on TransUnion should review whether applicable state law would permit the case to be heard in state court.

(My thanks to my colleague Ross Corbett, an associate in Winston & Strawn LLP’s Chicago office, who helped draft this post.)