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One good thing that occurred during the pandemic was the expansion of telehealth.  Telehealth existed already and probably would have been expanding anyway, but patient willingness to get care from home instead of risking exposure from an in-person visit paired well with provider interest in not going to or even having to maintain an office.  As technology has expanded, the range of telehealth services available now includes some pretty cool stuff.  For instance, a patient with a cochlear implant can be across the country from her providers with a laptop installed with special software and provide enough audiological data to facilitate the diagnosis of a post-implant hearing deficit.

By contrast, one of several dark sides of technology is how it can impinge on personal privacy.  Data breaches of electronic medical records or other protected health information are scary, but there are many potential nefarious infringements.  A few years ago, a popular smartphone app developed in Russia generated age progression images based on scanning a user’s face.  If the scanned image was retained, then an unscrupulous possessor of the image could put it to bad use.  The same goes for scanned images of fingerprints and retinas.  Way back in 2008, Illinois enacted a Biometric Information Privacy Act (“IBIPA”) largely because of concern about the ramifications of “biometric-facilitated financial transactions, including finger-scan technologies at grocery stores, gas stations, and school cafeterias.”  740 ILCS 14/5(b).  The idea was that “public welfare, security, and safety [would] be served by regulating the collection, use, safeguarding, handling, storage, retention, and destruction of biometric identifiers and information.”  740 ILCS 14/5(g).  To help send the message, a private right of action for “aggrieved” people without any proof of injury was created.

We are not fans of consumer fraud-type class action litigation in part because an injury should be a predicate to civil recovery.  Not only are there constitutional limits on justiciability, there is common sense.  Personal injury plaintiffs, even those seeking medical monitoring, business tort plaintiffs, and just about every other civil plaintiff has to show a tangible physical or economic injury.  To paraphrase Palsgraf, an injury in the air will not do.  There is an exception to that when it comes to states that sue on behalf of their citizens in parens patriae actions.  Although those cases have their own issues, at least they are not—or should not be—a vehicle to make professional plaintiffs and plaintiff lawyers lots of money over no actual losses.   Of course, a harm to a civil right counts even if there is no accompanying physical injury or economic damages.  Assuming here that there is still a right to privacy in the post-Dobbs world of diminished substantive due process—statutes and state constitutions can be a basis, at a minimum—one can see how another obtaining your private information without your permission would merit redress even without, for instance, reputational damage.

In Marino v. Gunnar Optiks LLC, 2024 IL App. (1st) 231826 (Ill. App. Aug. 30, 2024), the intermediate appellate court in Illinois ruled on a narrow appeal in a purported class action brought under IBIPA.  For our perspective, the ruling has potentially broader implications for telemedicine and medical device manufacturers.  The facts are not terribly complicated.  A plaintiff claimed to have used the defendant’s website to shop for both prescription glasses and non-prescription glasses.  The website used some sort of facial scanning to aid in fit and selection.  Because the lawsuit was ginned up, there is no information in the opinion about whether plaintiff purchased any glasses or was somehow duped into using the facial scanning feature.  Instead, there is a bare allegation that the defendant’s software collected her “biometric identifiers and biometric information” and violated certain provisions of IBIPA, presumably by its disclosure and retention practices, although she certainly could not have known anything about the latter.  IBIPA exempts from its requirements “information captured from a patient in a health care setting or information collected, used, or stored for health care treatment, payments or operations under [the federal privacy statute] HIPAA.”  The court below dismissed the IBIPA claims as to the prescription glasses but not as to the non-prescription sunglasses based on its determination of the scope of the exemption.  The manufacturer’s certified appeal was on the limited issue of whether “an individual who tries on non-prescription sunglasses utilizing a virtual try-on tool that captures certain biometric information considered a patient in a health care setting” under IBIPA.

At first glance, you might think “people buy non-prescription sunglasses at gas stations too, so nothing about buying them on-line would make the process health care.”  Or, if you were lawyer with some knowledge of the regulation of medical devices, you might think “sunglasses are a medical device, so their use is a kind of healthcare and purchasing them with facial scanning occurs in a healthcare setting.”  The Marino court’s analysis supporting its affirmance—that is, the use of the virtual try-on tool for non-prescription sunglasses was not exempt under IBIPA—largely turned on principles of statutory interpretation and which dictionary definitions made sense to the court.  With all due respect to the panel and the Illinois legislature, we do not find that part of the decision terribly interesting.

[T]he health care exclusion applies, in our view, where what would otherwise be biometric identifiers are taken from an individual who is presently awaiting or receiving medical care in a time, place, or circumstance where efforts are being made to maintain, restore, or promote that individual’s well-being, especially as performed by trained and licensed professionals. In light of the broad current use of telehealth, the setting itself might be almost anywhere but the definition is limited by the requirement that the individual is awaiting or receiving medical care and the information is being collected as part of an effort to maintain or restore or promote that person’s well-being.

2024 IL App. (1st) 231826, *29.  Sunglass shoppers are not covered by this exemption “because they are not presently awaiting or receiving medical care.”  Id. at *30.

That seems a bit presumptuous and short-sighted—pun possibly intended—to us.  What if the facial scan helps determine which sunglasses will best limit light to the eye of a person whose migraines are triggered by bright light?  What if the shopper used the scan to help get prescription glasses—the exemption for which was not challenged on appeal—with the assistance of a healthcare professional and then proceeded to also get non-prescription sunglasses with gratuitous assistance from a healthcare professional?  What if someone with prescription contact lenses consulted the website for prescription glasses, decided to stick with contacts, and then got non-prescription sunglasses that worked well with the contacts?  That is the presumptuous part.  The short-sighted part is that encouraging telehealth is good public policy and discouraging it is not.  Good healthcare will often involve treating the whole patient, and not just the specific issue for which the patient sought care. In other words, not all beneficial interaction that a healthcare provider has with a patient will be precisely “medical care,” such as where a non-mental health provider helps support emotional well-being along with care directed to a condition within her specialty.  It would be perverse for the requirements of and potential liability under something like IBIPA to apply to a healthcare professional’s capture or use of biometric information in an appointment that did not stick to the purely medical.

In reaching its conclusion, the Marino court elected not to follow three contrary Northern District of Illinois decisions on virtual try-on software for non-prescription eyewear.  Part of what those cases found persuasive was that non-prescription sunglasses are regulated as medical devices by FDA.  Marino rejected the importance of that fact because sunglasses are Class I medical devices, like adhesive bandages, crutches, and toothbrushes, which the court did not consider sufficiently medical to count.  Id. at *38.  Not to be too pedantic, but the qualifier “medical” is in the terms “Class I medical device,” “Class II medical device,” and “Class III medical device.”  One of the parts of the definition of “medical device” under the FDCA is that the device is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”  Adhesive bandages, crutches, and toothbrushes clearly meet that definition.  If a scan is used to determine the correct crutch height or underarm shape for a patient after a surgery, that sounds like a medical use.  If a patient is directed to take a digital photograph of wound so that the healthcare provider can recommend what over-the-counter adhesive bandage would work best, that sounds like a medical use.  We could go on.

It is worth noting that the sentence in IBIPA right after the sentence the court analyzed states that “Biometric identifiers do not include an X-ray, roentgen process, computed tomography, MRI, PET scan, mammography, or other image or film of the human anatomy used to diagnose, prognose, or treat an illness or other medical condition or to further validate scientific testing or screening.”  740 ILCS 14/10.  Thus, the examples above would be exempt from IBIPA according to IBIPA language that the Marino court did not mention.  Treating everything remotely connected to health as medical care has its own problems, for sure.  However, there should be a balance between encouraging the use of biometric information in ways that are good for society and limiting the improper use of such information without consent.  Throwing in potential class action liability for purported breaches that cause no actual harm does not help with that balance.

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Plaintiff lawyers read this blog, which we like. Criticism occasionally comes our way because the blogposts – horrors! – harbor a particular point of view. And that point of view occasionally gets recharacterized as bias or an admission against our clients.  Such recharacterizations are invariably nonsensical. So far, they have never obtained even a foothold with courts. 

A couple of times we’ve been criticized for repeating someone else’s point of view.  For example, we’ve quoted the American Tort Reform Association (ATRA) designation of certain jurisdictions as legal “Hellholes.”  What is an ATRA Hellhole?  In general, the reference is to court systems in which corporate defendants have a tough time getting a fair shake, either as a result of one-sided procedures, or mis- (or non-) application of legal principles, or a local habit of letting juries run away toward massive damages and far from reason or proportionality. For more specifics, see the ATRA list, which lays out detailed reasons why certain jurisdictions are inordinately hostile to our clients. You might say that the ATRA Hellhole list is nothing but bellyaching by fat cats.  But you’d be wrong. 

Law firms that defend big corporations and charge high rates are seldom modest. They regard themselves as being good at what they do.  They might even regard themselves as elite. Here’s the best test of whether that is true: do clients trust you with high-stakes, difficult cases in difficult jurisdictions?  In other words, if you are a defense hack of more than middling competence, you probably spend lots of time in ATRA Hellhole jurisdictions. The first rule is do not complain about it.  As Hyman Roth said in Godfather 2, this is the business we have chosen. The second rule is resist despair and fight the good fight.  

We recently had the experience of sojourning in two ATRA designated judicial Hellholes for two different clients in two different mass torts. The two experiences were very different, though each was illuminating. We offer an account as a sort of worm’s view supplement to ATRA’s description. To our mind, ATRA gets it right.  But knowing something and experiencing something are not the same.  Here is what it feels like to labor in a judicial Hellhole. 

The first adventure took place not just in a particular jurisdiction, but in a particular docket within that jurisdiction.  ATRA warns that the judge who oversees that docket has been brutal to corporate defendants. The pretrial rulings hardly ever favor the defense, the conduct of trial is, er, challenging for the party seated further from the jury, and after the jury returns the inevitable plaintiff verdict, the judge is more likely to issue an additur than a JNOV.  We had read this depressing account before we headed into the courtroom for a full day of pretrial festivities.  

We were spectators as much as participants, because we were not representing the lead defendant.  Another (very fine) set of lawyers was charged with that responsibility.  They took the lead on most of the motions and argued them exceedingly well. Didn’t matter.  The judge did not even attempt to hide full-blown contempt for the defense positions.  There was a visible, emotional aspect to the judge’s adverse rulings.  The judge seemed angry that the defense had the temerity to try to defend itself. But when the plaintiff lawyers argued, the judge’s features softened. There were nods of appreciation, and occasional suggestions for other points that might support the plaintiff’s position.  We couldn’t help but recall the old Rumpole of the Bailey stories by John Mortimer (who was himself a barrister in London courts). Dear old Rumpole at one point politely inquired of a judge whether they might be more comfortable climbing down from the bench and assuming a seat at opposing counsel’s table.  

The judge drastically curtailed the scope of defense expert witness opinions. It seemed that these rulings were animated not so much by the rules of evidence as by the simple fact that the judge disagreed with the defense experts.  The judge also excluded most theories of alternative causation.  There were several moments when it looked as if the judge would issue a directed verdict in favor of the plaintiff.  Why even go through a show trial?  

We had heard that this judge sometimes told defendants in open court that they were in for a rough time, so maybe they should seriously consider settlement.  Mind you, these suggestions of reeling in ambitions and settling for a nonoptimal amount were never directed to plaintiffs.  Anyway, we did not get to hear that speech from the judge.  But we did get the message.  After seeing, hearing, and feeling the reasons for ATRA’s entirely correct designation, we got out.  Did the judge’s in terrorem approach work? Yes.  Do we hate that? Yes. 

As Lenin wrote, What is to be Done?  We noticed that most of the arguments by the plaintiff were presented by local counsel, who had clerked for the judge.  That was a smart move. The judge seemed to hang on every word of the ex-clerk plaintiff lawyer. The lead defense counsel also employed a local counsel who was a former clerk for the judge.  The judge said some nice things about that ex-clerk, and there were probably some benefits for the defendant.  But the judge’s palpable dislike for the defendant prevailed over whatever residual fondness the judge had for the defense-side clerk.  

Our advice?  Stay away.  Get out of cases early, do as little business in the jurisdiction as possible, and drive 500 miles out of the way if need be to avoid being anywhere near the place. If anything, the ATRA Hellhole designation understates how one-sided the court system (at least the one specific docket) is in this otherwise charming place. 

The second adventure was different.  We were well aware that the court system had a reputation for being allergic to summary judgment, for never-ever limiting plaintiff expert testimony (it is a non-Daubert jurisdiction), and for blessing eye-wateringly high jury verdicts.  Moreover, there was some case law in the jurisdiction that seemed to smile upon an extension of liability to defendants that were pretty remote from the plaintiffs.  There was plenty of case law from other jurisdictions blasting such an extension of liability, but we had been warned that the judges here were completely uninterested in what other jurisdictions had to say.  Though we were in a big, cosmopolitan city, the judges were hopelessly provincial. 

But the judge presiding over our summary judgment motion was not closed-minded or hostile.  We got a fair hearing.  Guided by the local lawyers’ advice to focus only on local precedents, we assembled a summary judgment argument that the fundamental principles of tort law in this jurisdiction were at odds with the plaintiffs’ effort to sue everyone in sight.  We thought we were merely making a decent record for appeal from what we were sure would be a denial of our motion.  Not so.  The judge took a short break, then returned with a well reasoned analysis of the relevant tort law, and then tossed the case out completely.  

Two ATRA Hellholes, two different outcomes.  The ATRA descriptions were largely accurate.  In the first case, being forwarned was not quite the same as being forearmed.  If you are in front of a judge who is hellbent on clobbering you and/or your client, there is not much you can do.  (You might think about assembling a strong record for appeal, but, for various reasons, the judge in the first jurisdiction does not get reversed.) By contrast, the other place, even with some unfriendly cases and procedures and customs, still allowed one to act like a lawyer, and not just play the part of a lamb led to the slaughter.  The advice in the second jurisdiction not to waste time on extra-jurisdictional case law was useful.  

No one has written about Hell so well as Milton.  He wrote that “The mind is its own place, and in itself/Can make a Heaven of Hell, and  Hell of Heaven.”  Life is more about how we react to things than the quality of the things themselves.  Through thoughtfulness and will, we can “make a Heaven of Hell.”

Well, except maybe for that one jurisdiction ….

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Adding to the growing favorable precedent concerning state human tissue shield statutes is Heitman v. Aziyo Biologics, Inc., 2024 WL 4019318 (N.D. Fla.  Jul. 22, 2024).    

The plaintiff alleged that he was infected with tuberculosis from an unfortunately contaminated human tissue allograft that was implanted in his spine during surgery. The plaintiff alleged that he has experienced serious side effects from that infection. He and his wife filed a complaint against the defendants. The complaint included causes of action for strict products liability and breach of the implied warranty.  Id. at *1.   

The defendants moved for partial summary judgment. The central legal issue was whether Florida’s human tissue shield statute barred the strict liability and warranty claims.  The statute provides that:

the procurement, processing, testing, storage, or providing of human tissue and organs for human transplant . . . is the rendering of a service; and such service does not constitute the sale of goods or products to which implied warranties of merchantability or fitness for a particular purpose are applicable.  No implied warranties exist as to defects which cannot be detected, removed, or prevented by reasonable use of available scientific procedures or techniques. 

Fla. Statute § 672.316(6).  Florida’s blood shield statute contains similar language which has been interpreted by Florida’s Supreme Court to bar both strict liability and breach of implied warranty claims.  Id. at *2.

Plaintiffs only opposed dismissal of their implied warranty claims arguing that the human tissue shield statute precludes warranty claims only for defects that cannot be scientifically detected which is not the case for tuberculosis.  Id. at *2.  No Florida court has yet to interpret the human tissue shield statute, much less address the narrow issue of whether it bars implied warranty claims for “detectable defects.”  Therefore, applying the Erie doctrine, the court could make an “educated guess” on how the Florida Supreme Court would rule, but could not “create or modify” state law.  Id. at *3.  Therefore, “without something more on this issue of first impression,” the court was not willing to put “its own gloss on” the statute.  Id.

Applying the plain language of the statute, the court dismissed all strict liability, express warranty, and implied warranty claims.  The court also noted that it did not have authority to certify a question to the Florida Supreme Court, but that perhaps on appeal the Ninth Circuit would. Id. at n.5.           

Stay tuned for more favorable rulings in this case.

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We recently examined one possible beneficial impact of the Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024) – that it could bring about critical re-examination of the FDA’s questionably supported ban on truthful off-label speech.

Well here’s another one:  Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

We’ve already detailed a number of ways in which Lohr is of questionable validity:  (1) it relied on a presumption against preemption that has since been repudiated; (2) it addressed an anachronistic form of device clearance that no longer exists; (3) Congress revamped device clearance in 1990 to provide preemptive “reasonable assurance” of “safety”-based special controls; and (4) Justice Gorsuch had written an opinion questioning Lohr before he was elevated to the Supreme Court.

To that we can now add Loper Bright.  To satisfy not-so-idle curiosity, we recently searched Supreme Court opinions for references to Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), the decision that Loper Bright expressly overruled.

And there it was in Lohr – cited no fewer than four times.

Lohr, as we’ve discussed before, created an extra-statutory “device specificity” requirement that appears nowhere in the relevant preemption clause. 21 U.S.C. §360k(a).  It also invented the so-called “parallel claims” exception to preemption, also without any express statutory support.  The majority relied on the FDA’s regulatory interpretation of the FDCA (in addition to the now-rejected presumption against preemption) in recognizing these restrictions on express preemption of medical device tort claims.

As to parallel claims, the Lohr majority found that “[t]he FDA regulations interpreting the scope of §360k’s pre-emptive effect support [plaintiffs’] view, and our interpretation of the pre-emption statute is substantially informed by those regulations.”  518 U.S. at 495 (emphasis added).

Congress has given the FDA a unique role in determining the scope of § 360k’s pre-emptive effect. . . .  Because the FDA is the federal agency to which Congress has delegated its authority to implement the provisions of the Act, the agency is uniquely qualified to determine whether a particular form of state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” and, therefore, whether it should be pre-empted. . . .  The ambiguity in the statute − and the congressional grant of authority to the agency on the matter contained within it − provide a “sound basis,” for giving substantial weight to the agency’s view of the statute.

Id. at 495-96 (citing Chevron).  Thus, Lohr held, “regulations promulgated by the FDA expressly support the conclusion that §360k ‘does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.’”  518 U.S. at 496-97 (quoting 21 CFR § 808.1(d)(2)).

Lohr also relied on “the critical importance of device specificity in our (and the FDA’s) construction of §360k.”  518 U.S. at 502.  The majority found the plaintiffs’ argument that “§360k(a) mandates pre-emption only where there is a conflict between a specific state requirement and a federal requirement ‘applicable to’ the same device” was “supported by the FDA regulations, which provide that state requirements are pre-empted “only” when the FDA has established ‘specific counterpart regulations or … other specific requirements applicable to a particular device.’”  Id. at 498 (again quoting §808.1(d)).  Rotely following the FDA-added limitations on preemption Lohr stated:

[T]he regulations provide that state requirements of “general applicability” are not pre-empted except where they have “the effect of establishing a substantive requirement for a specific device.”  Moreover, federal requirements must be “applicable to the device” in question, and, according to the regulations, pre-empt state law only if they are “specific counterpart regulations” or “specific” to a “particular device.”  The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations.

Id. at 500 (again quoting §808.1(d)).

Chevron is cited again in Justice Breyer’s concurring opinion in Lohr – also to justify using the FDA’s regulatory gloss to narrow the express terms of the FDCA’s device preemption provision:

[T]his Court has previously suggested that, in the absence of a clear congressional command as to pre-emption, courts may infer that the relevant administrative agency possesses a degree of leeway to determine which rules, regulations, or other administrative actions will have pre-emptive effect.

Lohr, 518 U.S. at 505-06 (citing, inter alia, Chevron, 467 U.S. at 842-45).

The dissent in Lohr also had plenty to say about Chevron deference – and how it shouldn’t apply at all:

The Court holds that an FDCA “requirement” triggers pre-emption only when a conflict exists between a specific state requirement and a specific FDCA requirement applicable to the particular device.  The plurality emphasizes the “critical importance of device specificity” in its understanding of the pre-emption scheme.  To reach its particularized reading of the statute, the Court imports the interpretation put forth by the FDA’s regulations. . . .  Apparently recognizing that Chevron deference is unwarranted here, the Court does not admit to deferring to these regulations, but merely permits them to “infor[m]” the Court’s interpretation. It is not certain that an agency regulation determining the pre-emptive effect of any federal statute is entitled to deference, but one pertaining to the clear statute at issue here is surely not. . . .  Where the language of the statute is clear, resort to the agency’s interpretation is improper.  See Chevron [citation omitted]. . . .  [T]he term “requirement” encompasses state common-law causes of action.  The Court errs when it employs an agency’s narrowing construction of a statute where no such deference is warranted.  The statute makes no mention of a requirement of specificity, and there is no sound basis for determining that such a restriction on “any requirement” exists.

Lohr, 518 U.S. at 511-12 (citations and quotation marks omitted).

Well, Chevron is no more.  Further, a majority of the Court has since sided with the Lohr dissent on the FDA lacking the power to define the scope of FDCA preemption.  See PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 n.3 (2011) (“[W]e do not defer to an agency’s ultimate conclusion about whether state law should be pre-empted.”); Wyeth v. Levine, 555 U.S. 555, 576-77 (2009) (“we have not deferred to an agency’s conclusion that state law is pre-empted” because “agencies have no special authority to pronounce on pre-emption absent delegation by Congress”).

The demise of Chevron deference thus – independently of all of Lohr’s other flaws – calls into question the entire anti-preemption edifice that courts have constructed from its twin holdings that invented both “parallel claims” and “device-specific” limits on medical device preemption.  Loper Bright reads much more like the Lohr dissent, than it compares to either the majority or concurring opinions in Lohr.  Loper Bright essentially tells courts to ignore administrative interpretations and to give statutes “the reading the court would have reached if no agency were involved,” 144 S.Ct. at 2266 (citation and quotation marks omitted).  “[T]he interpretation of the meaning of statutes, as applied to justiciable controversies, [i]s exclusively a judicial function.”  Id. at 2258 (citation and quotation marks omitted).  “[A]gency interpretations of statutes − like agency interpretations of the Constitution [which is what preemption is] − are not entitled to deference.”  Id. at 2261 (emphasis original).

In an agency case as in any other, though, even if some judges might (or might not) consider the statute ambiguous, there is a best reading all the same − the reading the court would have reached if no agency were involved.  It therefore makes no sense to speak of a “permissible” interpretation that is not the one the court, after applying all relevant interpretive tools, concludes is best.  In the business of statutory interpretation, if it is not the best, it is not permissible.

Id. at 2266 (citation and quotation marks omitted).

Obviously, we don’t think that either of the two atextual glosses that Lohr created to cabin the otherwise broad language Congress used in §360k(a) is the “best” reading of the FDCA.  We thus urge defendants, post-Loper Bright, to consider taking on frontally these invented limitations on express preemption .  Pick your spots, of course, but be prepared to lose in courts that still wrongly consider themselves bound by Lohr.  Preserve the issue for appeal.  When it eventually reaches the United States Supreme Court, and it should, we have a good chance of prevailing.

It’s time.

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We reported last year on a case in which the Arizona Court of Appeals allowed FDA-approved drug warnings to define the standard of care for a physician’s informed consent.  Why does that matter?  Well, in most every jurisdiction, a plaintiff bringing an action for medical negligence has to produce expert opinion that the defendant breached a standard of care.  The Arizona Court of Appeals drove a hole through that requirement and held that the plaintiff could reach a jury with evidence that his physician failed to pass on an FDA-approved black box warning—without the support of any expert testimony that the physician was negligent. 

As we noted, this case was an outlier, and there is much wrong with the rule it erected.  Drug labeling has never been intended to set a nationwide standard of care for medical treatment, and such a rule ignores local standards and individual patient needs. 

The Arizona Supreme Court evidently saw those problems and has now reversed the opinion.  In Francisco v. Affiliated Urologists Ltd., No. CV-23-0152-PR, 2023 WL 11903729 (Ariz. Aug. 16, 2024), the Arizona Supreme Court held that, under the circumstances of the case, Arizona law does not permit an FDA-required warning “to substitute for the required [expert] testimony and independently establish the standard of care.”  Id. at *1.  Since those “circumstances” featured a black box warning, the FDA’s strongest, we doubt there is any FDA-based way around the Arizona expert requirement in malpractice cases.

The plaintiff in Francisco was a retiree who sued his doctor after the doctor prescribed Cipro to prevent post-surgery infection.  Like all prescription drugs, the labeling for Cipro set forth information about the drug, including a black box warning advising of “disabling and potentially irreversible serious adverse reactions.”  These risks included tendon rupture, peripheral neuropathy, and other thoroughly unpleasant-sounding conditions.  It is, however, within a physician’s learned discretion whether and how to discuss prescription drugs with his or her patients, and this physician chose not to discuss these risks or anything else about Cipro with this patient.  Id.

Days after starting on Cipro, the plaintiff experienced tingling and itching, and he eventually suffered “numerous ruptured tendons through his body” and other pain.  All we can say is, Ouch.  Having ourselves passed well beyond middle aged, we feel for this fellow.  The problem for his case though was that he could not find an expert who could opine that his physician breached the standard of care in obtaining informed consent.  An Arizona statute requires expert opinion, but the Court of Appeals gave the plaintiff a pass and allowed the FDA-required black box warning act as a substitute. 

The Arizona Supreme Court closed that door.  To begin with, the Arizona statute at issue (which is similar to other states’ laws) clearly required it.  The plaintiff’s claim for lack of informed consent, even if recast as a claim for “negligent disclosure,” was a claim for alleged negligence in the rendering of health care, i.e., a med mal claim.  The statute requiring expert opinion applied.  Id. at *4-*5. 

Moreover, the circumstances of the case did not warrant creating an exception.  Sure, there are cases where a lay jury does not need expert opinions to understand the issues, but this was not one of them:

[T]he pertinent question is whether the warning may be used instead of testimony from an expert witness to establish the standard of care.  The only exception to the statutory requirement for expert testimony lies within the common-law doctrine of res ipsa loquitur [. . . , which] applies where “the negligence is so grossly apparent that a layman would have no difficulty recognizing it.”

Id. at *5-*6 (quoting Riedisser v. Nelson, 534 P.2d 1052, 1054 (Ariz. 1975)).  Examples include leaving a large “cloth sack” in a surgical patient or a sewing up a patient with a six-inch metal clamp still inside.  Id. at *6.  You get the idea. 

Warnings, however, are different.  Even with a black box warning that addressed the exact complication that allegedly befell this patient, it was the physician’s role to evaluate the risks and benefits and obtain this patient’s informed consent.  Whether that process met the standard of care can be established only through an expert: 

In prescribing Cipro, [the physician] had to evaluate the concomitant risks and benefits of prescribing the drug to determine what information to disclose.  This evaluation considered, among other things, [the plaintiff’s] health . . . .  Although the black box warning indicated significant risks for older patients with a history of corticosteroid use, it could not account for [the plaintiff’s] individual situation, including his presentation as a vigorous and active older adult. 

In such a circumstance, “only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy.” 

Id. at *6 (emphasis added, quoting Watts v. Medicis Pharm. Corp., 365 P.3d 944, 949 (Ariz. 2016)).  As a result, a lay juror would not know, as a matter of common knowledge, whether the physician’s alleged failure to warn departed from the relevant standard of care.  Id. at *7.  Expert testimony is required. 

This is the rule in other jurisdictions, and for good reason.  Drug manufacturers prepare drug warnings for many reasons, including regulatory compliance, managing potential liability, and providing useful information to physicians.  Drug labeling is not intended to preempt a physician’s judgment, nor is it intended to impose liability if a physician does not follow the label.  Id. at *7-*8.  As we have said more times than we can count, physicians have every right to prescribe drugs off label, and off-label use has itself has become the standard of care in some situations. 

In addition, drug manufactures prepare drug labeling for medical professionals, not the general public.  Drug labeling therefore is not designed to be easily understood by lay jurors, at least not without expert assistance.  Still further, relying on FDA-required warnings “as a substitute for expert testimony . . . may result in drug manufacturers and the FDA determining the standard of care for Arizona medical malpractice claims.”  Id. at *8.  That is contrary to the law in Arizona. 

Finally, the plaintiff argued that requiring him to establish the standard of care through expert testimony violated the anti-abrogation clause of Arizona’s Constitution, which commands that the “right to recover damages for injuries shall never be abrogated.”  Many state constitutions have similar clauses, and plaintiffs often trot out these clauses when challenging tort reform statutes.  Here, it was a losing argument.  Requiring expert testimony did not abrogate the plaintiff’s claim.  He had every right and ability to bring his claim, but he had no constitutional right to prevail.  Id. at *9-*10.  He similarly had no right to bootstrap his claim onto FDA-required warnings. 

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Today’s guest post is from Reed Smith counsel, and rock music aficionado, Kevin Hara. He describes the twists and turns of pursuing an unreasonable plaintiff and counsel who unwisely turned down a Florida offer of judgment in a sizable damages/lousy liability case. While the victorious defendant didn’t get all the costs and fees it wanted, the award was still sufficiently sizeable to be a Heartbreaker for the other side. As always our guest posters deserve all the credit (and any blame) for their work.

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Disclaimer: this post is not from the Butler Snow side of the blog

Although I am proud to consider myself a connoisseur of 80s music and pop culture, I have a deep appreciation for music many would consider to be superior, including classic rock, such as the Eagles, and the British invasion bands such as the Beatles and the Rolling Stones.  Today’s decision is an excellent example of the detrimental consequences of hubris, and evokes a Stones classic “You Can’t Always Get What You Want.”  (Perhaps equally apropos might be “I Can’t Get No Satisfaction).”  It’s rather remarkable to think the aforementioned songs were written in 1969 and 1964, respectively, yet they remain relevant, and the band is still touring 60 years later. Whether the Stones are still worth watching in person is another matter.)

In Cates v. Zeltiq Aesthetics, Inc., plaintiff—or likely his counsel—rejected the defendant’s offer of judgment and as a consequence paid a steep price once the trial court granted summary judgment in favor of the defendant, and the Eleventh Circuit affirmed.  2024 U.S. Dist. LEXIS 117010, at *3 (Mag. M.D. Fla. July 2, 2024), adopted, 2024 U.S. Dist. LEXIS 126027 (M.D. Fla. July 17, 2024).  This blog previously discussed the sound reasoning by the trial and appellate courts in granting summary judgment for the defendant due to the manufacturer’s accurate, clear, and unambiguous warnings, and lack of any design defect.  If anyone ever wondered whether a statutory offer of compromise actually has teeth and truly impacts a party who rebuffs such an offer—the answer is a resounding yes—at least in Florida.  Perhaps the result may indeed make plaintiff long for “Yesterday”  Although Cates should give pause to plaintiffs and their counsel who might otherwise spurn reasonable settlement offers, the case likewise reminds defense counsel who make offers of judgment to document their billable hours carefully, and to avoid any appearance of either block billing or repetition.  Don’t give courts any reason to let unreasonable plaintiffs off the hook.

In Cates, the plaintiff brought an action against the manufacturer of a medical device that provides “intense cooling to targeted areas of the body” in order to freeze and naturally eliminate fat cells.  Id. at *2.  Plaintiff claimed to have experienced Paradoxical Adipose Hyperplasia (“PAH”)—a recognized and warned-of complication of the procedure—and alleged product liability claims for defects in design and warnings, negligence, negligent and fraudulent misrepresentation.  Id.  PAH is a rare but serious side effect of cryolipolysis, in which the fat in the treated area enlarges and hardens, requiring surgical treatment.  Thus, Cates was probably a significant damages/lousy liability case.

Plaintiff sought the usual:  economic and noneconomic relief, punitive damages, attorneys’ fees and costs.  Id.  In March 2020, approximately seven months after plaintiff commenced the litigation, the defendant served a “Proposal for Settlement (“Proposal”) under Fla. Stat. §768.79 and Fla. R. Civ. P. 1.442,” offering to settle the case for $20,000.  Id. at *3.  Plaintiff declined the Proposal—which he undoubtedly later regretted—after which the trial court granted summary judgment in favor of defendant on all claims.  This result was affirmed on appeal in April 2021.  Id. at *3-4.  The ensuing fee dispute took three years (longer than the case’s dubious merits) to resolve.

Fla. Stat. §768.79 is designed to encourage settlements, penalizing a party who rejects a good faith offer and later recovers less than the settlement amount.  Numerous states have similar statutes, and California practitioners are no doubt familiar with the analogous California Code of Civil Procedure Section 998.  (Speaking of California, I was fortunate to attend a concert during the “Hell Freezes Over” tour that included an incredible acoustic rendition of “Hotel California”). Florida’s version provides, in relevant part “if a defendant files an offer of judgment which is not accepted by the plaintiff within 30 days, the defendant shall be entitled to recover reasonable costs and attorney’s fees,” from the date the offer was filed if the defendant is found not liable or plaintiff obtains a judgment “at least 25 percent less than” the offer. See Fla. Stat. §768.79(1). (emphasis added). 

The plaintiff’s rejection of the $20,000 offer that preceded summary judgment for the defendant triggered §768.79’s cost and fee recovery provisions and, therefore, the question was how much the defendant would recover.  The defendant sought “fees in the total amount of $1,101,189.63 for work performed by its attorneys after service of the offer of judgment through the entry of final judgment” (but did not seek appellate fees), which plaintiff opposed.  2024 U.S. Dist. LEXIS 117010 at *4.  The magistrate judge recommended an award of $655,690.19.  Id.  Although the defendant did not recover the entirety of the amount sought, the award is sizable enough to serve the statute’s intended deterrent function against plaintiffs who are apt to overvalue their cases, and demonstrates that the Florida offer of judgment statute is nothing to be trifled with.

In calculating fee awards, Florida follows the lodestar method which multiplies “the number of hours reasonably expended by a reasonable hourly rate,” with the party seeking fees bearing the burden to demonstrate the hours and hourly rates are reasonable.  Id. at *5 (citation omitted).  The applicant must produce “satisfactory evidence” that the rate requested comports with the “prevailing market rates” with sufficient documentation of the number of hours and applicable rate.  Id.  Further, the “Florida Supreme Court has held that attorneys’ fees awarded pursuant to section 768.79 are sanctions . . . for unreasonable rejections of offers of judgment.”  Id. at *6 (internal quotation marks and citation omitted).  Moreover, because the fee award is a penalty, everything is construed in favor of the party against whom the penalty is imposed.  Id.

That’s probably why the magistrate went over the defendant’s bills with a fine-toothed comb.  About the only thing not clipped was defense counsel’s rates, which both sides’ experts agreed were reasonable.  Id. at *13.  Particularly problematic were the criticisms of defendant’s redactions from counsel’s billing entries, which the court concluded made it “impossible to ascertain the tasks that were completed, much less whether they were reasonable and necessary,” and essentially “render[ed] the billing entries meaningless.”  Id. at *23.

Sorry, we agree with the defendant that significant redactions are necessary to maintain attorney-client privilege and work-product confidentiality.  Id. at *25.  The magistrate dismissed those arguments, citing a lack of ongoing litigation.  Id. at *25.  Talk about Sympathy for the Devil.  Well, this litigation may be over, but there might be more, and without redaction, privileged information would be disclosed and potentially make its way to other litigants.  More specifically, unredacted billing entries could provide plaintiff’s counsel with a roadmap of the defense’s litigation strategy and work product.

Thus, the decision sets up something of a “Catch 22” for defendants seeking costs under §768.79 (or, indeed, for other reasons), by criticizing “block billing,” id. at *29, 32, but then demanding that detailed billing not be redacted and must also be sufficiently descriptive to support a fee award.  To enforce these contradictory positions, the decision recommended an “across-the-board reduction on the hours requested, . . . proportional to the level of redactions by each firm.”  Id. at *28.

On a better note, the plaintiff also argued that the defendant failed to provide “evidence of the fees it actually paid to its attorneys,” and claimed that it should not have to pay amounts defendant did not.  Id. at *47.  The court dismissed that argument as “perfunctory and unpersuasive,” ruling defendant provided proof of its “flat fee arrangement . . . billing records and a fee expert Declaration – which is precisely what the law require[d].”  Id.

Despite the excessively rigorous and picayune examination of the defendant’s fees, it nonetheless recovered $655,690.19.  That should still be enough for Cates to be a cautionary tale to overly zealous plaintiff’s attorneys – and a reminder to defense counsel − that Fla. Stat. §768.69 has real heft.  Although billing and time entry can be mundane and tedious, it remains an important part of legal practice and needs the same precision and attention to detail as all other legal work.  Regardless, defense counsel no doubt were happy enough with the result that they could just “Take It Easy,” and “Let It Be” perhaps while enjoying Florida’s weather, taking in a “Tequila Sunrise.”

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In Clemens v. DaimlerChrysler Corp., 534 F.3d 1017 (9th Cir. 2008), the court, applying California law, correctly “decline[d plaintiff’s] invitation to create a new exception” to that state’s privity requirement “that would permit [plaintiff’s] action to proceed.”  Id. at 1023-24.  “[A] federal court sitting in diversity is not free to create new exceptions” to state law limiting liability.  Id. at 1024 (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).  D&Z held, as we’ve discussed many times:

A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

423 U.S. at 4.  And the Supreme Court has kept on saying this.  Erie principles prohibit “federal judges” from “displac[ing] the state law that would ordinarily govern with their own rules.”  Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988).  “[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.”  Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

But when updating the learned intermediary section of his treatise, Bexis came across a peculiar MDL holding, that because a defendant supposedly “cite[d] no cases” for the proposition “that the learned intermediary doctrine should apply to Plaintiffs’ . . . consumer protection claims” under the laws of California, Maryland, Illinois, and Florida, then “the learned intermediary doctrine should not apply” to claims brought by plaintiffs in any of these states.  In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023).  The decision did not cite any precedent from any of these states (not even a trial court decision) affirmatively creating any exception to the learned intermediary rule for consumer fraud claims.  Id.

Continue Reading Debunking Another Stunningly Wrong MDL Expansion of Liability
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Speaking of the United States’ newly ratified Constitution, Benjamin Franklin wrote in 1789: “in this world nothing can be said to be certain, except death and taxes.”  We would like to add to this list another certainty—summary judgment in a drug case without expert proof of general causation.  So, when the court excluded all of plaintiffs’ causation experts late last year, the writing was on the wall.  The court then disposed of a belated nuisance expert. Now, the other shoe has dropped in In re: Acetaminophen – ASD-ADHD Products Liability Litigation, 2024 WL 3874183 (S.D.N.Y. Aug. 20, 2024).

The Acetaminophen MDL concerned allegations that pre-natal use of the over-the-counter pain reliever led to the development of autism spectrum disorder and attention deficit hyperactivity disorder in children.  Since all fifty states require medical causation expert opinions as a perquisite to trial in medical issue cases, once the court excluded all of plaintiffs’ experts, it put plaintiffs on a short timeline to show cause why summary judgment should not be granted across the board.  Plaintiffs argued that they could establish general causation by cobbling together a few prior statements by one of defendants’ experts who had repeatedly testified to just the opposite.  Id. at *2. 

Defendants’ expert is a world-renowned expert on ADHD whose expert opinion was that “there is no reliable scientific evidence that maternal use of acetaminophen causes ADHD in offspring.”  Id. at *4.  And none of his “prior statements,” contradict that conclusion that he reached using the Bradford Hill criteria (discussed in more detail in our prior post).  The statements plaintiff tried to rely on fell into three categories.  First, statements that don’t refer to acetaminophen at all but generally to environmental risk factors for ADHD.  Id.  Second, statements that acknowledge an association between prenatal acetaminophen use and ADHD—a fact that is not in dispute.  But association is not causation.  Allowing evidence of association asks the jury to consider the “possibility of causation.”  Any such verdict would be “steeped in speculation.”  Id. Third, defendants’ expert has referred to acetaminophen as a “risk factor” for ADHD but has also explained that “risk factors” do not mean causation.   A common misunderstanding that

Highlight[s] the impropriety of inviting a jury to speculate as to whether a patchwork of [defendants’ expert’s] out-of-context statements, rather than his expert opinion to the contrary, proves general causation.    

Id. at *5.

Not only did plaintiffs mischaracterize many of defendants’ expert’s statements, they

fundamentally misunderstand[] the process by which scientists assess the issue of general causation. . . . Plaintiffs’ proposal — that a series of disparate scientific observations is adequate for a jury to find general causation — is not viable. The issue of general causation in this litigation is complex and serious. Juries are entitled to a thoughtful, reliable analysis by a qualified expert.

Id. at *6. 

That was plaintiffs’ third attempt at establishing general causation, and three times was enough for the court.  All plaintiffs’ claims were dismissed, and final judgement entered for defendants.  For an MDL that started out with a really bad preemption decision,  the course correction on general causation got us all the way home in grand style.

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Even though lawyers who bill for their time defending product liability cases might favor those cases sticking around and plaintiffs getting many chances before inevitable dismissals with prejudice, we have been clear that we think plaintiffs should not get to re-plead around preemption once courts have defined the preempted path.  There seems to be an unwritten three strike rule when it comes to complaints, meaning it is often not until a second amended complaint that asserted claims are dismissed with prejudice in response to 12(b)(6) motions. See here, here, and here.  When it comes to motions to dismiss on preemption—which is a way in which a plaintiff can fail to state a viable claim—one strike should usually be enough unless the plaintiff avails herself of Fed. R. Civ. P. 15(a)(1)(B) or a state equivalent to put in an amended complaint in response to a motion to dismiss.  Given the availability of the opportunity to amend a complaint as of right, the first time a court dismisses claims as preempted the dismissal should be with prejudice.

Almost nineteen months ago, we detailed a pretty good decision finding all the product liability claims asserted as to a prescription drug to be preempted, although only some of the claims were dismissed with prejudice.  It should not have taken much more time for plaintiff to try and fail to re-plead non-preempted claims.  Yet, plaintiff here got the leeway a plaintiff often gets and it ultimately took more than thirty-three months from filing for the defendants to get a complete dismissal with prejudice.  Brashear v. Pacira Pharms., Inc., No. 1:21-cv-700, 2024 WL 3860465 (S.D. Ohio Aug. 19, 2024).  We say defendants because plaintiff served two additional related entities after the manufacturer largely won its first motion to dismiss.  Those additional defendants offered a range of grounds for dismissal, but we will focus on preemption.  After its original order, the court also granted plaintiff’s motion to change the dismissal of one of the claims from with prejudice to without prejudice.  Then the plaintiff missed her deadline to file an amended complaint, which ended up being largely a re-hash of her prior complaint.

Ultimately, three asserted claims were at issue in Brashear II.  Plaintiff alleged that the drug’s label was inadequate because it was not changed after approval to add a warning about a purported risk of injury to the diaphragm.  Consistent with the refreshing change in the drug product liability litigation landscape from Levine to Albrecht, the court stated “most failure-to-warn claims are preempted because drug labeling is highly federally regulated.”  2024 WL 380465, *5.  As before, plaintiff could not base a claim on the defendants’ alleged failure to seek approval for a labeling change because such a claim would be based on an obligation that exists only because of the FDCA.  Id.  It would also run afoul of the independence principle from Mensing because the court cannot presume that FDA would have approved the labeling change if requested.  Plaintiff also got a chance to articulate why defendants should have utilized a CBE to make a labeling change based on new information of a risk, but her amended complaint did not come close:

Despite claiming in an earlier filing that she could provide new allegations to that effect, Brashear has pointed to no facts that plausibly suggest such new information exists.

Id. at *6 (emphasis in original and internal citation omitted).  Although not mentioned in the amended complaint, plaintiff tried to point to a case report involving one patient who took a different drug.  Not only could this “evidence” not in the pleadings not be considered at this stage—it was certainly not judicial notice material—it “does not permit of a plausible inference that such a paper constitutes newly acquired information serving as evidence establishing a causal link between the drug in question and the alleged risk of harm.”  Id. at *6 & n.8 (emphasis in original).  That meant dismissal of the warnings claim with prejudice as to all the defendants.

Next up was a “false marketing claim,” which was really an attempt to assert a failure to warn claim based on something other than the content of the label.  Despite Brashear I making it clear that the alleged misrepresentation had to be outside the label to have a chance at not being preempted, plaintiff “cites only representations Defendants made on Exparel’s label as the basis for her claims that she was misled into believing that the drug was safe and effective for pain management.”  Id. at *6.  Dismissal with prejudice on that one too (but no costs for wasting everyone’s time).  Given the drug’s approved indications—that is, the local and regional analgesic uses for which FDA has determined the drug is safe and effective—plaintiff would have had to have some extra-label false promise of efficacy for an off-label use.

Last was a “supplier liability claim.”  Again, this was really a slightly re-packaged design defect claim, which the manufacturer had already gotten dismissed with prejudice in Brashear I.  The court saw this particular formulation as a “stop-selling” claim preempted by Bartlett.

As Brashear fails even to address the preemption issue latent in this stop-selling argument, the Court adheres to its previous determination that Brashear may not challenge the “dangerousness” of Exparel to maintain her supplier liability claim.

Id. at *6 (internal citation omitted).  Another dismissal with prejudice (but no costs for wasting everyone’s time).

If we have been too subtle—a rarity, for sure—we think there should be some penalty to deter this kind of litigating by the plaintiff.  When a plaintiff takes a voluntary dismissal and re-files, Fed. R. Civ. P. 41(d) authorizes the court to “order the plaintiff to pay all or part of the costs of that previous action” and “stay the proceedings until the plaintiff has complied.”  Maybe amending complaints in response to 12(b)(6) motions or orders on 12(b)(6) motions should involve the same dynamic, with the Rules specifically authorizing courts to impose a sort of user fee from the plaintiff if she insists on taking another swing.

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We’ve all heard that “what’s good for the goose is good for the gander.” Some of us describe it as “the rule of poultry equivalents.” However you phrase it, we’ve always thought that if a defendant’s insurance is routinely discoverable, a plaintiff’s litigation financing agreement should be as well. Today’s decision from Delaware, Burkhart v. Genworth Financial, Inc., 2024 WL 3888109 (Del. Ch. Aug. 21, 2024), isn’t a pharmaceutical or medical device case, but it is the fourth decision out of the Delaware state courts holding that a plaintiff’s litigation funding agreement is discoverable.  The decision adds to some of the positive case law and local rules related to litigation funding that we’ve addressed here, here and here.  

Continue Reading Litigation Funding Agreements Discoverable in Delaware

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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