It’s unusual when the same defendant wins two unrelated cases involving the same product in the same week – and on the same issue. But it does happen, and recently, in both Benn v. Medtronic, Inc., 2023 WL 3966000 (D.N.J. June 13, 2023), and Warmoth v. Medtronic, Inc., 2023 WL 3938464 (W.D. Okla. June 9, 2023), express medical device preemption carried the day, in decisions issued only four days apart.
That’s worth a blogpost – and two cheers. Hip hip!
Continue Reading A Preemption Two-Fer
We’ve blogged before about the plaintiffs’ self-defeating “injury” definition in the Taxotere mass tort litigation. Specifically, plaintiffs have defined their injury as being hair loss that persists more than six months after their cessation of treatment with the defendant’s cancer chemotherapy drug. But, because this litigation (like most product liability MDLs) only exists because of lawyer solicitation, such solicitation dredges up many plaintiffs who sat on their hands for much longer than the aforesaid six month period. Having a date certain as to when the injury exists greatly assists any defendant in winning dismissal of these stale claims on statute of limitations grounds.
That’s not just true in the Taxotere MDL
Continue Reading Taxotere Timing Troubles Persistently Plague Plaintiffs
Long, long ago, when we clerked for a federal district judge, we handled more than a few prisoner cases. We have to confess that many of the ones we saw were humorous to us, because they alleged a range of perceived slights and personal affronts as violations of their constitutional rights. (As readers know, we take constitutional rights seriously. That applies to prisoners too, but we are talking about allegations regarding the purported right to masturbate and the purported right to be free of guards claiming they were having sex with the prisoner’s wife.) Some of the prisoner plaintiffs were frequent flyers. Because prisoners are often allowed to proceed in forma pauperis under 28 U.S.C. §1915, without filing fees and with time on their hands, some prisoners brought case after case. Some of them may have thought their cases were all well founded and some may have found them good ways to pass the time. We are not sure what they thought, but we know that §1915 allows the courts overseeing such a case to dismiss it sua sponte if the court determines at any time that “the action or appeal—(i) is frivolous or malicious; (ii) fails to state a claim on which relief may be granted; or (iii)seeks monetary relief against a defendant who is immune from such relief.” The frequent flyers we saw back then were flagged to get a substantive review of their complaints with their pauperis applications. Many of those cases ended at that point.
We know of nothing like this screening procedure for frequent flyers who pay filing fees, but maybe there should be. The cottage industry of “patent trolls” who tend to bring case after case in a single district court has been well described. There are also frequent flying consumer protection trolls who team up with the same lawyers to bring questionable cases in the apparent hope that defendants will pay to avoid the nuisance. When we read Valiente v. Publix Super Markets, Inc., No. 22-22930-Civ-Sola, 2023 U.S. Dist. LEXIS 91089 (S.D. Fla. May 24, 2023), we thought it had an interesting discussion of standing, which we have addressed a few times recently in the context of medication abortion litigation. See here, here, and here. We might have focused on the relationship between Valiente, the medication abortion decisions, and some of the other standing issues that are percolating. Instead, we noticed that the Valiente judge cited an arguably inconsistent decision in a case called Valiente v. Unilever United States, Inc., rendered by another judge in the same district, and we traveled down a little google hole. The other Valiente had a different first name, but they seem to be related by blood or marriage because of a common address and founding positions with a now-defunct Florida corporation. The share the same lawyer too. We have since noticed that this lawyer has been called out by multiple federal judges for filing a raft of weak consumer protection cases about a wide range of products. That lawyer has also represented the first Valiente in at least two other consumer fraud type class action cases in the same district, one against a manufacturer of sneakers and athletic wear and the other against a manufacturer of home exercise machines over telephonic solicitation. (We talked about the latter type of suit here.) The judge for the first Valiente case was also the judge for the case against the home exercise machine manufacturer, which looks like it was dismissed and re-filed in California federal court. Our google dive was far from exhaustive, but it was enough to tell us that this plaintiff wishes to make a career out of being a wannabe class rep and this judge should have known it. We do not think our eyes are the only ones sufficiently jaundiced by frivolous litigation to see that such a plaintiff, especially when represented by such a lawyer, is unlikely to be suing to redress some actual harm.
That brings us back to the standing issue. Plaintiff sued over his purchase of a drug store’s brand of honey-lemon cough drops. He claimed to have been misled by pictures of a honeycomb and a half lemon, along with the phrase that the product “soothes sore throat[s],” on the outer packaging. 2023 U.S. Dist. LEXIS 91089, *2. Per his amended complaint, he wanted to be the rep of classes covering purchasers in a number of states who purchased the cough drops for a “premium price” because they were, like he alleged was, under the impression that the drops had “a non-negligible amount of lemon” and that they “acted on bronchial passages.” Id. at *2-3. These allegations were facially questionable because the packaging listed the ingredients—no lemon—and made clear than menthol was the active ingredient. Also, he paid a whopping $1.79 for 30 drops or roughly $0.06 per drop. Although plaintiff had asserted six different claims, defendant’s challenge to standing required that the court address only the request for monetary damages and the request for injunctive relief.
As we have detailed recently, the Supreme Court’s decision in Spokeo v. Robins, 578 U.S. 330, 338 (2016), directs the standing inquiry to whether the plaintiff has “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Although the TwIqbal decisions are not cited in Valiente, a plaintiff cannot get past a standing challenge at the pleading stage merely by alleging that these elements have been met. As to plaintiff’s claim for monetary damages, he had a hard sell to establish an injury in fact. Right on the package of the cough drops, defendant offered an unconditional money back guaranty. 2023 U.S. Dist. LEXIS 91089, *5-6. Absent some allegation that he tried and failed to get his $1.79 back—something most people would not attempt unless they were trying to become a class rep—the existence of the guaranty mooted any possible injury in fact. We are not suggesting all consumer product sellers offer unconditional money back guaranties, but it sure makes sense that they would negate consumer fraud claims by purchasers (as opposed to state AGs).
Valiente went further and held that plaintiff’s allegations of harm due to paying a “premium price” for his cough drops did not lead to standing. For one thing, that $0.06 per cough drop was a premium price was based on a conclusory allegation without any factual support. Id. at *9 & 13. We did a little marketplace research on a fluvial shopping site and could find no cough drops sold for less than $0.06 per. If you bought more than 300 at once, then you could get close to the per drop price the Valiente plaintiff paid. For another, plaintiff did not allege that he would not have bought the cough drops had the packaging been different. Other plaintiffs, including the other Valiente, had apparently slipped past standing challenges based on conclusory allegations that they would not have bought the product at all. This plaintiff merely alleged that he would have paid some unspecified amount less than he did. Id. at *10-11. This potential $0.01 of damages was too oblique to credit. In addition, plaintiff did not allege the cough drops did not work as well as expected or even that their composition made them “materially different from how they are marketed by [defendant].” Id. at *12. Thus, plaintiff’s “allegations as to why he has been deprived of the benefit of the bargain all boil down to his subjective, personal expectations of what the cough drops purported to do.” Id. at *14. That is insufficient for standing and similar reasoning should apply to a number of ginned-up consumer fraud claims. (We also think it should apply to the “subjective, personal expectations” for how the world should be offered up as a basis for standing in the AHM case, but we will not hold our breath on that.)
Standing for plaintiff’s injunctive relief claims was even easier to address. He had no past injury in fact—see above—and had no allegations supporting future harm that an injunction would prevent. Id. at *15. He alleged that he “will purchase the [cough drops] again when he can do so with the assurance the [p]roduct’s representations are consistent with its abilities, attributes, and/or composition,” and not otherwise. Id. at *16-17. Perhaps a professional plaintiff and lawyer who had filed more than 400 similar federal lawsuits since 2020 should have coughed up something better, but their failure meant that, as alleged, plaintiff would suffer no future injury if nothing changes. That means there is nothing to enjoin.
One final note—and this may be where a frequent flyer gets less rope—is that plaintiff’s case was dismissed with prejudice on his second attempt at a viable complaint. We have decried that plaintiffs often get three or more chances to plead before they face dismissal with prejudice. Here, plaintiff buried a request for leave to amend with his response to a motion to dismiss rather than filing a timely motion to amend, which the court did not excuse. Id. at *18. A dismissal with prejudice is good, but, absent imposing costs or sanctions—or even getting flagged for some early screening procedure—professional plaintiffs will get to keep playing their games without much risk.
Here’s a shocker: being a tv star doctor does not make one a viable expert under Federal Rule of Evidence 702. That’s not just our say-so (or ipse dixit). One of our reliance materials is Thelen v. Somatics, LLC, 2023 U.S. Dist. LEXIS 101970 (M.D. Fla. June 12, 2023). The plaintiff in that case claimed that he suffered serious neurological injuries from undergoing electroconvulsive theory (ECT). (We have written about ECT litigation before – here for example. Indeed, we have written about the Thelen case a couple of times before; for example, this post was about confidentiality.) To support this claim, the plaintiff hired a doctor as an expert to testify that ECT could injure brains. That expert turns out to be the same doctor who became famous for diagnosing concussion-related brain injuries in football players. He should have stuck to football players.
The defendant moved to exclude the expert’s opinions on both general causation (can ECT cause brain injury) and specific causation (did the ECT cause the plaintiff’s injuries in this case.) The court denied the motion on specific causation, but granted the motion on general causation. Why did the plaintiff expert’s general causation opinion flunk Rule 702? It wasn’t on the basis of lack of qualifications. The court assumed that the doctor was qualified. But his opinions on ECT suffered from lack of reliability. His opinion was basically “because I say so.” He never articulated any methodology based on either epidemiology or dose response. Of course, the plaintiff expert did not go down without a fight. The court had to do some blocking and tackling before getting to the right Rule 702 result. (Yes, the court talks in terms of Daubert, but if you’ve been following this blog, you know that we’re moving away from that terminology, freighted as it is with so much obsolete, bad law, and sticking to the current, and soon even better, version of Rule 702).
In the course of its opinion, the court said some things we like to see in a Rule 702 analysis (the court should be a “gatekeeper,” the plaintiff bears the burden, etc.) and some things we don’t like so much (e.g., the hated “flexibiity”). But the court’s analysis of general causation is, at least to our defense hack eyes, completely persuasive. The Thelen court observed that the primary methods for establishing general causation “are analysis of epidemiological studies (to the extent they can be reliably applied to the facts of the particular case), analysis of dose-response relationship, and examination of the background risk for the particular disease or condition.” So far, so good. Then the Thelen court observed that “[s]econdary methods include the identification of plausible explanations for the mechanism of injury, generalized case reports, hypotheses, and animal studies.” The court emphasized that these “secondary methods do not by themselves provide proof of general causation.” That is a critical point, because in many cases the plaintiff expert comes in armed with those secondary methods without employing any of the primary methods.
The Thelen court also focused on “whether the expert’s testimony grows out of research the expert has conducted independently of the litigation, as opposed to having developed the opinions for the purpose of testifying.” Would you care to guess which category applied here? The plaintiff expert adopted the usual pose of acting like a real treating medical doctor by dressing up his opinion as a “differential diagnosis.” Nice try. The Thelen court held that a differential diagnosis is a specific causation theory inapplicable to general causation. (The Thelen court is also awarded points for mentioning that “differential diagnosis” in this scenario is really a loose term for a “differential etiology.” Plaintiff experts invariably choose the looser, incorrect term because it sounds more like what treaters actually do.) Up to this point, the plaintiff expert’s methodology looks both wrong and pointless.
What about the expert’s opinions that purported to demonstrate general causation? After being deposed and reaching opinions, he attempted to back them up with scientific studies after the fact. That was rejected as improper methodology − a result-before-research opinion. Simply reading the titles of articles at a deposition with no explanation is not reliable methodology. At his deposition, the expert “deflected questions about the specific content of the article by pointing out, as if to end the discussion, that the article had the word ‘morbidity’ in the title.” The plaintiff expert also claimed to rely on studies published in foreign languages he could not read. (Instead, the expert had relied on the abstracts.)
At bottom, the plaintiff expert’s general causation opinion rested on two propositions: “it is well accepted that the very purpose of ECT is to cause brain injury, and thereby induce a supposedly therapeutic seizure, and (2) the fact that ECT causes brain damage follows necessarily and obviously from basic scientific principles relating to brain injury.” That not-quite-syllogism did not impress the court. Rather, the court required the expert to provide copies of the medical/scientific literature he said he relied upon. The court then read the literature (gatekeeping, I’d done right, can be hard work) and determined that the literature did not support the expert’s opinions – in fact, some of the purportedly relied on articles directly contradicted his opinions. Oops. The court, as referee, blew the whistle and sent the expert off the field.
The Thelen court elegantly ended its Rule 702 exclusion of the plaintiff expert general causation opinion: “Choosing one side of the existing medical and scientific literature on a contested point, and citing one’s education, training, and experience as the basis for the choice, is not sufficient to demonstrate the admissibility of a general causation opinion.” That’s a judicial spiking of the football.
Since 2018, we have blogged several times about the federal government’s crackdown on abusive False Claims Act (“FCA”) litigation via motions for dismissal, and how the abusive relators have tried to resist those efforts. Last week the Supreme Court ruled that, yes, the government does have the power to shut down rogue litigation ostensibly being conducted in the name of the United States of America.
All the federal government has to do is intervene and give a coherent reason why.
Continue Reading Final Report From One FCA Front – As Another Front Opens
We always thought that the decade-old Nargol v. DePuy False Claims Act litigation was a particularly abusive misapplication of the FCA for legal reasons. As discussed here, the primary allegations asserted the same sort of “fraud on the FDA” claim that, when brought as a common-law tort claim, were held preempted in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) – that the defendant purportedly misled the FDA to clear a §510(k) medical device, and that, as a result, every use of the device was ipso facto a false claim. No other causation needed. As the earlier post discussed, the First Circuit rightly put an end to that attack on FDA authority in United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017).
Then it turned out that a lot more was wrong with Nargol than just a bogus legal theory. The relators were p-side “experts,” Antoni Nargol and David Langton, who had access to documents from a couple of MDLs that targeted the defendant’s hip implant products. Critically:
Protective orders regarding confidential [defendant’s] product design information were issued in both of the multidistrict litigation cases (individually, the “ASR protective order” and the “Pinnacle protective order”; collectively, the “Protective Orders”).
United States ex rel. Nargol v. DePuy Orthopaedics, Inc., ___ F.4th ___, 2023 WL 3746534, at *1 (1st Cir. May 18, 2023).
Continue Reading Dismissal of Experts-Turned-Plaintiffs’ FCA Case as Sanction Affirmed
We recently commented on claimants who manipulate and evade the Vaccine Act by making vaccine claims, only then to make no effort to pursue them. Their play is to abandon their claims after the statutory 240-day waiting period and file lawsuits, where they stand a better chance of recovering more money. Because we think the Vaccine Act is a reasoned and fair way to compensate patients who experience vaccine side effects, we frown upon claimants and attorneys who treat the vaccine claims process as an inconvenient way station on the way to MDL gold country.
Imagine then our mood when we read about a plaintiffs’ attorney who not only actively evaded the vaccine claims process for hundreds of claims, but then insisted he was entitled to fees for his “effort.” And, when the special master denied fees and costs, the attorney moved to disqualify him from all the attorney’s cases. We guess no good deed goes unpunished, even when you are a special master.
The case is Fetters v. Secretary of Health and Human Services, No. 21-928V, 2023 WL 3597513 (Ct. Fed. Cl. May 23, 2023), which was one of hundreds of similar claims from the same attorney. The petitioner submitted a claim through the Vaccine Program after her minor child allegedly experienced complications from an HPV vaccine. As we have explained before, the Vaccine Act sets up a no-fault claims process that claimants have to exhaust before they can sue in a court of law. Exhaustion is expected to involve adjudication and a result, but petitioners can also exhaust the administrative process by withdrawing their petitions if they have not been acted on within 240 days. See 42 U.S.C. § 300aa-21.
As mentioned, the petitioner in Fetters was one of more than one hundred vaccine claimants represented by the same attorney, who was eager to exhaust the claims process and get into the more lucrative land of multidistrict litigation. He was not subtle about it. He proposed that the court allow his HPV vaccine clients to file short-form petitions and be relieved of their obligation to file medical records and affidavits to support their claims. According to counsel, this would allow his clients to exhaust their Vaccine Program remedies “without requiring a ton of effort from the [c]ourt or anyone else.” Id. at *1.
We are sure the court appreciated counsel’s concern for the court “or anyone else,” but the Special Master’s Office declined to adopt a process aimed only at getting counsel’s claims through the Vaccine Program without adjudication and as fast as possible. In addition, the special master signaled that it would consider counsel’s “check the box” approach when considering requests for fees and costs. Id. at *2. Counsel therefore proceeded with his eyes wide open and continued to submit claims—and then made little effort to pursue them. In one case, the claimant requested eight extensions of time, ensuring that the claims process could not be completed within the statutory 240 days. Id. at *3. Sure enough, the petitioner withdrew her petition after 240 days and filed her lawsuit.
One of the curiosities of the Vaccine Act is that it allows an award of fees and costs even to unsuccessful petitioners, so long as they brought their claims in good faith and had a reasonable basis. Id. at *5. This petitioner’s attorney therefore applied for fees, in this case and his many others. We will repeat that. Counsel expressly and openly minimized the claims process and did not adjudicate his claims, but then expected to use that same process as a funding source.
The Special Master saw right through this:
[E]ven if petitioners may legitimately pass through the [Vaccine] Program en route to the ‘promised land’ of another forum in which they hope to receive a favorable determination, I am not compelled by the Act to turn a blind eye to this stratagem—especially since it is highly likely (if not a certainty) that this claim, as well as the other comparable claims being dismissed, would have resulted in an unfavorable determination had it been litigated fully in the Vaccine Program.
Id. at *8 (quoting related case, emphasis in original). The Special Master denied fees—not because they were lacking in good faith, but because the petitioner had not submitted basic supporting documentation and did not show a reasonable basis. She did not even submit the vaccine record, nor an affidavit explaining any effort to obtain the vaccine record. The Court of Federal Claims affirmed the denial of fees on that basis and ruled that the special master did not err by assigning little weight to other, circumstantial evidence. Id. at *5-*7.
If counsel had stopped there, we could chalk it up to zealous advocacy. Instead he responded to this threat to his funding by doubling down and moving to disqualify the special master from all his cases. The standard is whether a reasonable person, knowing all the facts, would question the special master’s impartiality. Id. at *4. Here, counsel took issue with the special master’s rulings and his comments regarding counsel’s “stratagem” and his intended pathway to “the promised land,” i.e., multidistrict litigation. The Court of Federal Claims ruled that counsel had not meet the heavy burden for disqualification and that the special master’s orders were “reasoned judicial rulings, routine case management decisions, and ordinary admonishments to counsel.” Id. at *7.
We have an annual ten best list and an annual ten worst list. If we had a top ten “chutzpah” list, this case would go on it.
The case we discuss today, Doe v. Ladapo, 2023 WL 3833848 (N.D. Fla. 2023), appeared in our daily search results because it briefly addresses off-label use of prescription drugs. Invalidating a state statute that would have prohibited a particular off-label use, the court explained that “[o]ff-label use of drugs is commonplace” and the fact “[t]hat the FDA has not approved” a drug for a particular use “says precisely nothing about whether the drugs are safe and effective when used for that purpose.” Id. at 15. The “defendants’ contrary implication,” said the court, “is divorced from reality.” Id. Indeed. We couldn’t have said it better ourselves.
But that is not why we chose to report on Doe. We bring it to your attention because it is a refreshingly clear judicial repudiation of bigotry.
Last month, hoping to advance Ron DeSantis’s political fortunes at the expense of transgender children, the Florida legislature enacted a statute that would prevent doctors from prescribing gonadotropin-releasing hormone (GnRH) agonists—colloquially known as “puberty blockers”—to treat transgender youth suffering from gender dysphoria. See Fla. Stat. § 456.001(9)(a); id. § 456.52(1) & (5). A mental-health condition recognized in DSM-5, the diagnosis applies when, among other things, an individual experiences both a marked incongruence between their experienced gender identity and natal sex as well as clinically significant distress or impairment. As the Doe court noted, gender dysphoria causes “transgender individuals [to] suffer higher rates of anxiety, depression, suicidal ideation, and suicide than the population at large.” 2023 WL 3833848, at *3. “There are well-established standards of care for treatment of gender dysphoria.” Id. In addition to psychological therapy, there are three types of possible medical intervention: 1. GnRH agonists, which delay the onset of puberty; 2. cross-sex hormones, which promote the development and maintenance of characteristics consistent with the individual’s natal sex; and 3. surgery, which can align physical characteristics with gender identify.
The Doe plaintiffs, parents of transgender children, challenge the state’s attempt to prevent trans youth from receiving GnRH agonists, alleging that the newly enacted don’t-be-trans statute violates their children’s right to equal protection (and their own rights as parents). The court agreed and enjoined the statute’s enforcement.
Rather than walk you through each step of the court’s analysis, we want to highlight some of its most trenchant observations, which are delivered with uncommon yet welcome bluntness.
The court begins by addressing “[t]he elephant in the room”—namely, the belief “that cisgender individuals properly adhere to their natal sex and that transgender individuals have inappropriately chosen a contrary gender identity, male or female, just as one might choose whether to read Shakespeare or Grisham.” Doe, 2023 WL 3833848, at *2. But, the court said, the record makes clear that, as one defense expert admitted, “[g]ender identity is real,” not a choice. Id.
Despite this admission, said the court, there was “an unspoken suggestion running just below the surface in some of the proceedings that led to adoption of the statute … at issue—and just below the surface in the testimony of some of the defense experts—is that transgender identity is not real, that it is made up.” 2023 WL 3833848, at *2. The court observed that “[m]any people with this view tend to disapprove all things transgender” and therefore “oppose medical care that supports a person’s transgender existence.” Id. The court cited several defense experts as examples, noting that one had joined an amicus brief in another case asserting that “transgender individuals have only a ‘false belief’ in their gender identity” and “are maintaining a ‘charade’ or ‘delusion’” while another had described gender-affirming care as “evil” and “diabolical.” Id.
Pointing to the defendants’ contradictory statements, the court declared that
[a]ny proponent of the challenged statute … should put up or shut up: do you acknowledge that there are individuals with actual gender identities opposite their natal sex, or do you not? Dog whistles ought not be tolerated.
2023 WL 3833848, at *2. As a child of the 1950’s Jim Crow South, the judge knows something about dog whistles.
Proponents of the don’t-be-trans statute argued that they were motivated by a desire to protect children, who, in the words of the statute, are “threatened with being subjected to sex-reassignment prescriptions,” which the statute equates to child abuse that would justify the state “tak[ing] physical custody of the child” from the child’s parents. Fla. Stat. Ann. § 61.534(1). The Doe court was having none of it. It found that the plaintiffs are motivated by their “love for their children and the desire to achieve the best possible treatment for them” but that “[t]his is not the State’s motivation.” 2023 WL 3833848, at *7.
On the contrary, said the court, the state’s motives were discriminatory, “motivated in substantial part by the plainly illegitimate purposes of disapproving transgender status and discouraging individuals from pursuing their honest gender identities.” 2023 WL 3833848, at *10. The statute is, in short, “purposeful discrimination.” Id.
The court noted that the defendants “proffered a laundry list of purported justifications for the statute” but found that “[t]he purported justifications are largely pretextual.” 2023 WL 3833848, at *11.
As for GnRH’s purported lack of proven safety and efficacy, the court found no evidence of either, finding instead that there is “extensive clinical experience showing excellent results from treatment with GnRH agonists and cross-sex hormones” and that “[i]f these treatments are prohibited, many patients will suffer needlessly.” 2023 WL 3833848, at *12.
Resisting the medical profession’s recognition of gender dysphoria and its treatments, the defendants argued that medical organizations had been captured by “woke” activists “who pursued good politics, not good medicine.” 2023 WL 3833848, at *13. Again, the court was having none of it: “If ever a pot called a kettle black, it is here. The statute and the rules were an exercise in politics, not good medicine.” Id.
Nor did the court buy the defendants’ contention that the Florida statute reflects an international “consensus” barring minors from receiving puberty blockers.
The assertion is false. And no matter how many times the defendants say it, it will still be false. No country in Europe—or so far as shown by this record, anywhere in the world—entirely bans these treatments.
To be sure, there are countries that ban gays and lesbians and probably transgender individuals, too. One doubts these treatments are available in Iran or other similarly repressive regimes. But the treatments are available in appropriate circumstances in all the countries cited by the defendants, including Finland, Sweden, Norway, Great Britain, France, Australia, and New Zealand.
2023 WL 3833848, at *14.
Echoing anti-choice campaigners’ argument that abortion should be banned because women end up regretting abortions, the anti-trans campaigners argued that doctors should be prohibited from prescribing puberty blockers to minors because when they grow up they will regret having taken them. But, the court noted, there is no factual support for the argument. “Regret is rare; indeed, the defendants have offered no evidence of any Florida resident who regrets being treated with GnRH agonists or cross-sex hormones.” 2023 WL 3833848, at *14.
Seeing past the pretext, the court found that “the state’s disapproval of transgender status—of a person’s gender identity when it does not match the person’s natal sex—was a substantial motivating factor in enactment of the challenged statute and rules.” Such invidious discrimination, the court held, violates the equal protection and is therefore “unconstitutional.” 2023 WL 3833848, at *14.
For now at least, a federal court has kept Florida from becoming Iran.
Law school taught us that design defect, manufacturing defect, and failure to warn are the big troika of product liability theories. Real life practice taught us that failure to warn is far and away the most common and dangerous claim we face. It is easy for plaintiffs to allege and easy for juries to follow – up to a point. Sometimes expert testimony bolsters the warnings story for one or both sides, but not always. Of course, on the defense side, we’re usually as happy as clams if we can show that the Food and Drug Administration (FDA) has already decided which warnings are necessary, so let’s call it a day.
And therein, in a strange way, lies our interest in Francisco v. Affiliated Urologists Ltd., 2023 WL 3589654 (Ariz. App. May 23, 2023). Francisco is an unpublished, nonprecedential opinion about a medical malpractice, not product liability, case. So why read this post? Maybe you should simply get on with your doom-scrolling.
First, Francisco is a flat-out fascinating case. We need more entertainments in our lives, wherever we can find them. Second, defense hacks worth the title should expand their taxonomy of warning cases. Here’s our warning to you: you never know when some weird, one-off case might help you map out a position on a warnings issue.
In Francisco, the plaintiff sued a medical practice for failing to inform him of the potential risks of taking ciproflaxin. It is likely that some of you have taken Cipro. If you have, it likely you have heard about potential adverse reactions relating to tendonitis or tendon rupture. But, apparently, the plaintiff in Francisco had not heard about such risks. The doctor prescribed Cipro for the plaintiff after a urological procedure. The plaintiff alleged that he suffered severe pain as a result of the procedure, that the doctor had not warned him of the risks, and that if the doctor had offered adequate information or prescribed a reasonable alternative, the plaintiff would have requested a different antibiotic.
It is pretty clear that Francisco is a medical malpractice action, right? The plaintiff tried to say it wasn’t, for reasons that will become clear shortly. Informed consent seems like a slightly different issue from, say, removing the wrong leg or leaving a sponge in the abdomen, but it is still (in most states)a species of negligence. If a doctor’s treatment of a patient is negligent, that usually spells medical malpractice. Arizona defines a medical malpractice claim as one based on “the health care professional’s alleged breach of contract, negligence, misconduct, errors or omission in rendering professional services.” There is no carve-out for informed consent. Consequently, the claim in the Francisco case implicates the Arizona statute (similar to statutes in most states) requiring medical malpractice plaintiffs to furnish up front an expert opinion that the defendant medical provider’s conduct fell below the standard of care. The plaintiff in Francisco had not supplied such an expert statement, and the defendant moved to dismiss the case on that ground. The lower court agreed with the defendant and dismissed the case with prejudice.
But the Arizona Court of Appeals reversed. Yes, the case was a med-mal case, and yes, the Arizona statute addressing the requirement of an expert opinion regarding deviation from the standard of care applied, but the requirement of an expert affidavit can be relaxed depending “upon the circumstances of the particular case.” Ugh. So much for legislatively defined bright-line rules. In Francisco, the plaintiff argued that there was no need for an expert to explain why the treating doctor needed to inform the patient of the risks of Cipro, because another, bigger expert already furnished that explanation: the FDA.
In 2016, the FDA “warned in its medication insert that Cipro can cause ‘disabling and potentially irreversible serious adverse reactions’ and instructed doctors prescribing Cipro to use caution ‘when prescribing Cipro to elderly patients, especially those on corticosteroids,’ to inform patients of this potential adverse reaction, and to give instructions ‘to discontinue Cipro use and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur.” At the time of the Cipro prescription, the plaintiff was 66 years old and had been taking corticosteroids for 40 years. His point was that the FDA warning instructions applied directly to him, yet the doctor had not given him those warnings.
More to the point, the plaintiff in Francisco argued that the explicit FDA warnings rendered unnecessary the requirement of an expert affidavit to the effect that the warnings should have been provided. An expert affidavit goes to standard of care and medical custom. But the jury does not need help on those issues from an expert “when, as here, the FDA directs physicians to advise patients of all risks associated with prescribed medications, provides physicians with a specific ‘black box’ warning, and the physician does not advise the patient of the specific warning. Here, specialized knowledge is not needed to evaluate whether the FDA instructed the doctor to give certain warnings to patients.” The FDA’s say-so is enough.
Anyway, the FDA’s say-so is enough to start the case and keep it going. The defendant has the option of offering “responsive expert testimony that physicians are free to ignore such a directive.” The point is that the FDA’s position permits the layperson “to determine whether, in the context of all evidence from both sides, the failure to warn constituted negligence.”
To our opportunistic eyes, that conclusion in Francisco suggests that, if not quite the last word, the FDA’s position should be a pretty big word in determining which warnings should be given. But don’t get too opportunistic. We’ve looked into this issue before, here, and it appears that Francisco is an outlier, even though that court doesn’t admit it.
Shortly after we recently posted our 50-state survey of state law concerning expert “gatekeeping,” we received a thoughtful email from friend-of-the-Blog Tom Hurney, of Jackson Kelly, informing us that there were additional gatekeeping-related issues in West Virginia that our search – limited to cases using the word “gatekeeping” – did not reflect. His email was sufficiently detailed that we invited Tom to prepare a guest post on the subject. He agreed, and here it is. As always our guest bloggers deserve 100% of the credit (and any blame) for their efforts.
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In the “50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping,” the Drug & Device Law Blog (the Best Blog on the Planet) describes West Virginia as a “gatekeeper” state because of cases reflecting adoption of the Daubert analysis of W. Va. R. Evid. 702 by the Supreme Court of Appeals of West Virginia. But while the Great, Wild, and Wonderful State of West Virginia indeed adopted Daubert in late 1993, declaring its circuit judges “gatekeepers” under W. Va. R. Evid. 702, that role and analysis was limited to scientific evidence in the case law. Then, in 2014 the Court amended Rule 702 from mirroring its federal counterpart to expressly limiting the Daubert admissibility analysis to “novel scientific theory, principle, methodology, or procedure.” Thus, while the Blog correctly celebrates West Virginia judges as Rule 702 gatekeepers, their role is narrower and the gate perhaps wider than elsewhere.
The Supreme Court of Appeals of West Virginia moved from the Frye test to Daubert in Wilt v. Buracker, 443 S.E.2d 196, 198 (W. Va. 1993). Noting W. Va. R. Evid. 702 was (at the time – more on this below) identical to the Federal Rule, the Court stated “we believe that Daubert is directed at situations where the scientific or technical basis for the expert testimony cannot be judicially noticed and a hearing must be held to determine its reliability. We conclude that Daubert’s analysis of Federal Rule 702 should be followed in analyzing the admissibility of expert testimony under Rule 702 of the West Virginia Rules of Evidence (italics added).” The Court applied the new Wilt/Daubert standard to find that expert psychological and economic testimony on “hedonic damages” – ginning up a psychological percentage and putting a dollar figure on loss of enjoyment of life – and held “[t]he loss of enjoyment of life resulting from a permanent injury is part of the general measure of damages flowing from the permanent injury and is not subject to an economic calculation.”
As the Blog noted, later cases affirmed the gatekeeping role. “The [procedural] regime contemplates that trial judges will perform a gatekeeping function, determining whether the . . . methodology underlying proffered expert testimony is scientifically valid and whether that . . . methodology properly can be applied to the facts in issue.” Harris v. CSX Transportation, Inc., 753 S.E.2d 275, 305 (W. Va. 2013) (citation and quotation marks omitted). “We . . . impose[] a ‘gatekeeper’ duty upon trial courts to screen scientific expert opinions to ensure relevancy and reliability.” Anstey v. Ballard, 787 S.E.2d 864, 880 (W. Va. 2016). In West Virginia, “a trial court has a gatekeeper obligation to screen scientific expert opinions for admissibility.” State v. Surbaugh, 786 S.E.2d 601, 609 (W. Va. 2016).
When scientific evidence is proffered, a circuit court in its gatekeeper role . . . must engage in a two-part analysis in regard to the expert testimony. First, the circuit court must determine whether the expert testimony reflects scientific knowledge, whether the findings are derived by scientific method, and whether the work product amounts to good science. Second, the circuit court must ensure that the scientific testimony is relevant to the task at hand.
San Francisco v. Wendy’s International, Inc., 656 S.E.2d 485, 493 (W. Va. 2007) (citation omitted). In exercising its role as evidentiary “gatekeeper” confronting scientific testimony, court must make a preliminary determination of “whether the reasoning or methodology underlying the testimony is scientifically valid” before the jury may receive it. State ex rel. Weirton Medical Center v. Mazzone, 584 S.E.2d 606, 611 (W. Va. 2003) (citation and quotation marks omitted); see also State v. Lockhart, 542 S.E.2d 443, 450 (W. Va. 2000) (trial court, as gatekeeper, must determine “whether expert scientific testimony reflects scientific knowledge, whether the findings are derived by scientific method, and whether the work product amounts to good science”).
But despite the language from Daubert quoted in Wilt about the “scientific or technical basis for the expert testimony,” a close read of these cases shows the Supreme Court discussed gatekeeping Wilt/Daubert in relation to expert “scientific” testimony; not all expert testimony. Indeed, the Supreme Court made it clear that the “Wilt/Daubert” analysis does not apply outside of “scientific knowledge” in Gentry v. Mangum, 466 S.E.2d 171, 174 (W. Va. 1995) (internal citations omitted):
The question of admissibility under Daubert v. Merrell Dow Pharmaceuticals, Inc., and Wilt v. Buracker, only arises if it is first established that the testimony deals with “scientific knowledge.” “Scientific” implies a grounding in the methods and procedures of science while “knowledge” connotes more than subjective belief or unsupported speculation. In order to qualify as ‘scientific knowledge,’ an inference or assertion must be derived by the scientific method. It is the circuit court’s responsibility initially to determine whether the expert’s proposed testimony amounts to “scientific knowledge” and, in doing so, to analyze not what the experts say, but what basis they have for saying it.
Gentry reversed the circuit court’s application of the Daubert/Wilt analysis to exclude the testimony of an expert on “police practice, customs, and safety standards” because “[t]he proffered testimony … does not present the kind of ‘junk science’ problem that Daubert/ Wilt meant to address.” The Court left challenging the basis of non-scientific evidence to cross examination under Daubert’s “shaky but admissible” test: “Disputes as to the strength of an expert’s credentials, mere differences in the methodology, or lack of textual authority for the opinion go to weight and not to the admissibility of their testimony. Daubert, 509 U.S. at 596 (“[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence…”) (citation shortened; italics added).
In Watson v. Inco Alloys Intern., Inc., 545 S.E.2d 294 (W. Va. 2001), the Court expressly declined to follow Kumho Tire Company, Ltd. v. Carmichael, 526 U.S. 137 (1999), which expanded the Daubert analysis under Fed. R. Evid. 702 to all expert testimony. “[W]e hold that unless an engineer’s opinion is derived from the methods and procedures of science, his or her testimony is generally considered technical in nature, and not scientific. Therefore, a court considering the admissibility of such evidence should not apply the gatekeeper analysis set forth by this Court in Wilt v. Buracker, … and Gentry v. Mangum, … (citations omitted).”
Then, in 2014, the Court amended W. Va. R. Evid. 702 with the comment “Rule 702 is a modified version of its federal counterpart. The revised rule applies existing case law that requires expert testimony based upon novel scientific theories to be evaluated by the trial court exercising its ‘gatekeeper’ function.” This handy chart compares the two Rules:
| West Virginia Rule 702 | Federal Rule 702 |
| If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education may testify thereto in the form of an opinion or otherwise. In addition to the requirements in subsection (a), expert testimony based on a novel scientific theory, principle, methodology, or procedure is admissible only if: the testimony is based on sufficient facts or data; the testimony is the product of reliable principles and methods; and the expert has reliably applied the principles and methods to the facts of the case. (bold added) | A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case. |
This doesn’t mean that experts can say anything in West Virginia. Experts must be qualified and have an appropriate basis for opinions. See, Otto v. Catrow L. PLLC, 850 S.E.2d 708, 715 (W. Va. 2020) (“[W]e cannot say that the circuit court abused its discretion in disregarding plaintiff’s [legal malpractice] expert opinion on the applicable standard of care” where the expert “possessed no knowledge whatsoever with respect to West Virginia law or the standards and actions routinely followed by real estate practitioners in the state.”) But the gatekeeper admissibility analysis under W. Va. R. Evid. 702 applies to “novel scientific theory, principle, methodology, or procedure.” See, Anstey v. Ballard, 787 S.E.2d 864, 881 (W. Va. 2016) (“Even today, the admissibility of the State’s expert testimony would be assessed under Rule 702 of the West Virginia Rules of Evidence as evidence based on technical or specialized knowledge—and not under Daubert/Wilt.”)
It does mean that West Virginia’s analog to Rule 702 has been moving away from, rather than towards, the current federal version.