Cutting Through the FDA Alternative Summary Reporting Fog

By Bexis on September 23, 2024

In an earlier post, we discussed how the FDA, for over twenty years, from mid-1997 through mid-2019, created and operated an “alternative summary reporting (“ASR”) system for many (but not all) medical device-related adverse events. In June 2019 the FDA “formally ended” the ASR program, “revoked all . . . exemptions,” and opened “all” ASR reporting data to the public through “legacy files.”

One quirk of ASR reports is that they could not be included on the FDA’s public “MAUDE” (Manufacturer and User Facility Device Experience) database of medical device adverse events, because the FDA required an incompatible format for ASR submissions. Predictably, plaintiffs in any litigation where the defendant’s participation in the FDA ASR program was relevant started screaming about “coverups” despite the FDA itself receiving all the adverse report data that it wanted, in a form that made it easier for the Agency to use. Plaintiffs doubled down on already suspect “failure to report” claims. They’ve been claiming that, under state tort law, device manufacturers had a “duty” not only to comply with FDA reporting requirements, but to do so in the most public manner possible, even when the FDA preferred streamlined ASR reporting.

Learned Intermediary Rule Still Alive and Well in California

By Steven Boranian on September 20, 2024

We have a couple of updates on the learned intermediary rule in California. We reported to you three months ago on the California Supreme Court’s tweaking of the learned intermediary rule in Himes v. Somatics, and the tweaks were not good. As we wrote back then, the Court did not make any fundamental change to the rule, which still holds that a prescription medical product manufacturer’s duty to warn runs to the prescribing physician, not the patient. The California Supreme Court’s twist is on causation. Under Himes, a plaintiff is not required to show in every case that a stronger warning would have altered the physician’s prescribing decision. Instead, a plaintiff can establish causation by proving that the physician would have communicated the stronger warning to the patient and that an “objectively prudent person in the patient’s position would have thereafter declined the treatment.” Himes v. Somatics, LLC, 16 Cal. 5th 209 (2024).

The first update is that plaintiffs are already trying to stretch the Himes opinion beyond bounds. We recently reviewed an opposition to summary judgment stating that so long as a plaintiff can show that he or she would not have taken a prescription drug after reading a label with a stronger warning, then the question of warnings causation goes to the jury, citing Himes.

That is completely wrong. Again, the California Supreme Court held that a plaintiff can prove causation by showing that his or her physician would have communicated a stronger warning and that “an objectively prudent” patient would then have declined treatment. The physician’s decisionmaking in treating patients and counseling with them about risks and benefits remains at the center of warnings causation. Moreover, the potential impact of the physician’s warnings on a patient is judged under an objective standard. Himes did not involve patients who themselves read drug labeling, and there is no scenario under Himes under which causation is established where the plaintiff “shows he or she would not have taken a drug.” The California Supreme Court and the Ninth Circuit have both expressly rejected the idea that that plaintiffs can defeat summary judgment with subjective, post hoc statements that they would not have taken the drug had they received a stronger warning. Himes, at 234. There is really no other way, given that every patient who has actually experienced a drug side effect and is suing to recover damages will say that he or she would not have taken the drug had he or she known.

Our second update is that a federal judge in California has now provided one of the first applications of Himes that we have seen, and the result is good. In Canty v. Depuy Orthopaedics Inc., No. 14-cv-05407, 2024 WL 4149954 (N.D. Cal. Sept. 10, 2024), the district court granted summary judgment on the plaintiffs’ warnings-based claims because the prescribing surgeon did not rely on materials from the defendant manufacturer when he decided to treat his patient with the defendant’s orthopedic implant. As a result, a stronger warning could not have impacted the physician’s prescribing decision, nor could it have impacted the physician’s counseling with the patient.

This is an important outcome because the California Supreme Court left open, in a footnote, whether the warnings causation chain is broken when the physician would not have read or otherwise been alerted to a stronger warning. Himes, at n.1. The district court in Canty ruled that, yes, the chain is broken. The surgeon could “not recall a single statement” or a “single document” from the defendant on which he relied, so it really did not matter what those materials said or what the plaintiffs thought they should have said. We frankly don’t know how anyone could come to a different conclusion, since a stronger warning cannot affect someone who did not read warnings in the first place. Id. at *4

The surgeon had been a consultant for the defendant and participated on a “surgeon’s panel.” According to the district court, however, although this “may suggest” that the surgeon gleaned additional information about the product, a “mere scintilla of evidence” is not sufficient to overcome summary judgment. In addition, the fact that the surgeon stopped using the particular implant at some later point in time was irrelevant because that did not establish what he would have done at the time he treated the patient had he seen a stronger warning. Id.

We expressed our concern that the Himes standard introduces unwarranted speculation into a standard that was and should be straightforward. The order in Canty is encouraging.

A Detour Through Materials Science, Followed By A Climb Up A Rule 702 Hill

By Lisa Baird on September 19, 2024

This post is from the non-Butler Snow side of the blog.

When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you will encounter both experts and “experts” (scare quotes intended) in materials science.

Materials science is the interdisciplinary study and analysis of product composition with application to the design, development and manufacturing of real products. It is something we have found weirdly interesting, ever since an amazing materials scientist explained that a favorite blazer with a nubbly texture never wrinkled because it had “predetermined collapse points.” Because of those predetermined collapse points, the garment never took on additional collapse points (aka wrinkles), no matter how badly it was squished in a suitcase. 3D printing/additive manufacturing is another area of interest to the blog, and another area where materials science matters quite significantly.

With that short detour over , turn with us now to Hill v. Medical Device Bus. Srvcs., Inc., No. 3:21-cv-0440, 2024 U.S. Dist. LEXIS 140272, 2024 WL 3696481 (M.D. Tenn Aug. 7, 2024), a case in which the plaintiff’s materials science expert was challenged and excluded, for good reason.

The plaintiff in Hill had two hip replacement surgeries. A 2014 surgery was for the initial implant of his total hip replacement system, and a 2015 surgery was to replace certain components, although one component, the femoral stem, was left unchanged. Five years later, the femoral stem component fractured, and the entire hip implant construct was explanted and replaced.

According to the court, the parties seemingly agreed that the femoral stem component broke due to a small flaw in its metal, “but they disagree[d] as to how that flaw came to exist”:

Defendant’s experts assert that a flaw was introduced to the product during surgery from the use of electrocautery… [whereas] Plaintiffs assert that a flaw was introduced to the product during the manufacturing process.

Hill, 2024 U.S. Dist. LEXIS 140272 at *4.

As our readers know, expert testimony is measured against the standard in the updated Federal Rule of Evidence 702, which emphasizes the importance of the gatekeeping function of our courts:

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 the proponent demonstrates to the court that it is more likely than not that:

(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’s opinion reflects a reliable application of the principles and methods to the facts of the case.

To its credit, the Hill court recognized the changes to Rule 702 were meant to give it more teeth, and that courts “can exclude a conclusion if it is based on methods that are unreliable (and thus do not serve to reliably substantiate the conclusion[)]”.

The Hill court also realized that Sixth Circuit cases applying the pre-amendment version of Rule 702 might be amongst the “misguided cases” that led to rules Advisory Committee to update Rule 702. But—in the only really confounding part of the opinion, footnote 9—the court believed that it had to follow Sixth Circuit authorities interpreting the previous version of Rule 702 even though Rule 702 itself has changed. See here for contrary Supreme Court precedent recognizing that rules changes, like statutory changes, overturn prior judicial precedent.

The good news is, the court did not need to resolve any finer points of the pre- versus post-Rule 702 amendment test to conclude that the plaintiffs’ materials science experts’ opinions were inadmissible.

Plaintiffs’ first expert was a well-credentialed materials scientist who opined that the critical flaw in the implant’s femoral stem was introduced during manufacturing, and that she had ruled out all other potential causes for the flaw. But, as the court recognized, she did not actually have any evidentiary basis for ruling out those other potential causes:

For example, she ruled out that the failure was caused by the Implant being placed at the improper angle during surgery, but [Plaintiffs fail] to explain how she can give that opinion when (as Plaintiffs do not dispute) she does not know the proper angle at which the Implant should have been placed. If she does not know what angle is improper, then she lacks a basis for saying that an improper angle did not cause the break. Similarly, she lacks a basis to rule out “trauma and blunt force” during surgery . . . because she did not know anything about how the surgery was conducted.

Hill, 2024 U.S. Dist. LEXIS 140272 at *21.

Moreover, although this expert testified it was possible for the flaw to have been introduced during manufacturing, the expert did not examine whether the defendant had appropriate measures in place to control the size of flaws during manufacture of its metal implants. Thus, she couldn’t actually tie the flaw in the plaintiff’s implant to the manufacturing process or to the reason the plaintiff’s implant broke.

With the plaintiffs’ first expert out, the second expert also had to be excluded: part of his opinion merely parroted the first expert and thus was unreliable, and the rest of his opinion was predicated on statements that the first expert never expressed.

With both of plaintiffs’ experts out, the Court concluded (quite rightly) that the burden of proof meant it did not need to consider challenges to the defendant’s experts and instead could just move on to the defendant’s motion for summary judgment.

Without experts to establish causation, summary judgment should have been—and was—a relatively easy grant. But plaintiffs tried one last gambit, the res ipsa loquitur-like malfunction theory: that the factfinder can infer defectiveness merely from the existence of an alleged malfunction and a negation of other causes.

We don’t buy the malfunction theory, just as we look askance at other variations of res ipsa loquitur. When the malfunction theory is accepted, it is supposed to be fairly rigorous: If the plaintiff can show that the product malfunctioned, and if the plaintiff also can negate all other causes for the malfunction other than a product defect, then the malfunction theory is applicable and an inference of a product defect is permissible.

But we find it often is trotted out just because the plaintiffs’ counsel or experts haven’t done their homework and are missing key pieces of evidence. The device must have had a defect, they will argue, because devices don’t just fail.

But the reality is that medical devices, particularly implanted medical devices, do fail for unknown reasons—and plaintiff’s second expert admitted as much here. And when the plaintiff has not actually negated all other causes of malfunction, then the malfunction theory just doesn’t apply:

[W]hen a device is known to fail for unknown reasons, it is pure speculation that a failure is attributable to a manufacturing defect and not some other unknown cause without evidence supporting one cause over another.

Hill, 2024 U.S. Dist. LEXIS 140272 at *49.

The plaintiff in Hill certainly did not negate all other potential causes of malfunction, and so the court came to the right conclusion: The defense wins.

An appeal has been filed, so we shall see if the Sixth Circuit agrees.

Our thanks to Robyn Maguire and Sarah Jin of Barnes & Thornburg for sending the case and a congratulations as well for the nice win!

Combatting Overpriced Plaintiff Experts

By Stephen McConnell on September 18, 2024

Whoever said “you get what you pay for” never deposed a plaintiff expert. Most plaintiff experts we’ve encountered acquired their expertise – if that’s what you want to call it – not in any substantive area but, rather, in slinging junk science hash at juries with a straight, and maybe even solemn, face. As if to add insult to injury, some plaintiff experts ask us to pay ludicrous fees for the privilege of deposing them and enduring 3-7 hours of relentless testi-lying. A couple of plaintiff experts even demanded that we pay them for their prep time. (When we flat out refused that last bit, one expert showed up at the deposition and answered almost every question with an extended declamation about how he could not answer because he hadn’t been compensated by us to study for the deposition.)

We get it that experts can be expensive. That applies to both sides. Long ago, we employed an expert in an antitrust case who had acquired notoriety in the Microsoft litigation for breaking the $1000 per hour barrier. Here’s the thing: he was really, really smart, he did a lot of work, and he could explain things so that even simpletons such as ourselves could grasp complex concepts. In another case, we helped prepare a Nobel Prize winning University of Chicago economist. He was alarmingly brilliant. Everything he said seemed original and insightful. During lunch at a Chicago pizzeria, he held forth about the comparative merits of deep dish vs NY pizza. All we could think at the time was that this guy was a Nobel Prize winner, and everything he said was profound. He was an oracle with a fee schedule. And that fee schedule was mighty steep. (The occasional former Surgeon General was about as impressive as anything we ever saw from the other side. And then after deposing such experts, we became a lot less impressed with that title. It was disillusioning.)

We have not run into any Nobel Prize winning plaintiff experts. All we get from them is “Bradford-Hill, differential diagnosis, blah blah blah.” There is bloviation and robotic “analysis.” What there is not is any sense of embarrassment about their ridiculous fees. Occasionally, these plaintiff experts demand deposition fees that are far north of what they get in their actual non-litigation practice (if that even exists). Is there anything that we defense hacks can do when a plaintiff expert quotes a deposition fee that is utterly disconnected from reality, regular fees, and good taste?

Yes, there is. And the recent case of Delrossi v. Morales-Ortiz, 2024 Conn. Super. LEXIS 1879 (Conn. Super. Ct. Sept. 24, 2024), furnishes a fine example. This decision would have fit nicely into our Stupid Expert Fees post.

In Delrossi, a plaintiff-side orthopedic surgeon expert who apparently frequents Connecticut litigation, demanded $5,000/hour for the first two hours of his deposition and $2,500 for every hour thereafter, in advance and effectively non-refundable. Wow. That doctor must have been nominated for a Nobel Prize, MacArthur Fellowship, or at least a Mass Torts Made Perfect Golden Bucket, right? Wrong. The defendants in Delrossi unsurprisingly found the fee exorbitant. The plaintiff stood on the expert’s fee schedule, without even a CV suggesting why such a fee was appropriate.

Though the Delrossi case was in Connecticut state court, the judge followed criteria that courts typically apply pursuant to Fed. R. Civ. P. 26(b)(4)(C). Those criteria, according to the Delrossi court, include: (1) the witness’s area of expertise, (2) the education and training required, (3) the prevailing rates of other comparably respected available experts, (4) the nature, quality, and complexity of the discovery responses provided, (5) the fee actually charged to the party who retained the expert, (6) fees traditionally charged by an expert on related matters, and (7) any other factors likely to assist the court in balancing the interest implicated by Rule 26. Applying these factors (especially number 3), the Delrossi court knocked the plaintiff expert’s fee down to $750 an hour. The opinion chiefly relies on two earlier cases involving orthopedic surgeons, which reduced the fee to $500 or $1000 an hour, and split the difference.

The Delrossi decision looks like common sense to us. It also suggests that if one is going to haggle over the fees for an expert deposition, both sides would be smart to consult the Rule 26 criteria listed by the Delrossi court and try to bolster the factual record. As in real estate, think first and foremost of comps. (That is, unless you are dealing with a Nobel Prize winner.)

The Litigation Transparency Act of 2024

By Michelle Yeary on September 17, 2024

Today’s guest post is from our Dechert LLP colleagues Doug Fleming and Noah Becker. They examine the recently proposed Litigation Transparency Act. As always our guest bloggers deserve all of the credit (and any of the blame) for their efforts.

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Consider the following scenario — it’s not an unusual one in this brave new world where third-party funding of mass tort litigation has exploded: After months of protracted settlement negotiations, including issues large and small, your client finally reaches an agreement with the opposing party. You and your client think you have closure. But before an agreement can be finalized, another figure emerges from the mist: a litigation funder who has different views and says its approval is required. This is not a hypothetical, but a result that third-party litigation funding can—and has—made a reality. Some members of Congress in both the House and the Senate have begun to take issue with this situation.

The most recent proposal to deal with it was re-introduced this July by Congressman Darrell Issa, specifically the Litigation Transparency Act of 2024 (the “LTA”). The draft statute consists of two provisions relevant to this scenario: (1) Parties are required to disclose—to the court and all other named parties—“any commercial enterprise (other than counsel of record) that has a right to receive any payment that is contingent on the outcome of the civil action or a group of actions of which the civil action is a part” and (2) “produce to the court and each other named party . . . any agreement creating a contingent right referred to in paragraph (1).” Thus, the LTA intends to give parties answers to two questions that supporters believe would have been non-controversial to answer only a short while ago: (1) Who is actually bringing this litigation and (2) Who is financially staked in it?

By way of recent background, this proposal follows another that was co-sponsored by a bipartisan quartet of senators, the Protecting Our Courts from Foreign Manipulation Act (the “FMA”), and is also still pending. The Senate bill requires somewhat similar disclosures but with respect to the particular concern that foreign nations are using “third-party litigation funding to support targeted lawsuits in the United States.” The FMA was originally introduced in September 2023 by Senators John Kennedy and Joe Manchin, and in June, attracted co-sponsor support from John Cornyn and John Hickenlooper.

In addition to a focus on opacity and disclosure issues, underpinning the view of supporters of the LTA in particular is that mass tort litigations are not capital markets. As Professor Donald Kochan explained, while testifying in June about litigation funding reform before the House Judiciary Subcommittee on Courts, Intellectual Property and the Internet, in order “to preserve the civil justice system as predictable, neutral, and accessible,” it must be “maintain[ed] . . . outside the market.” Kochan argues that “[w]hen litigants, or the investors propping them up can start using the court decisions as investment vehicles,” courts are changed into “something they are not intended to be, necessarily diluting their ability to serve their traditional role.”

Introduction of the LTA follows several litigations in which these issues have come into sharp focus. For example, in Nimitz Techs. LLC v. CNET Media, Inc., 2022 WL 17338396, at *26 (D. Del. Nov. 20, 2022), the parties were subject to a general standing order issued by Judge Colm Connolly that mandated that parties provide details about litigation funding somewhat similar to those proposed by the LTA. See Id at *3. No such disclosure was made, but Judge Connolly ultimately discovered that litigation funders were involved to such an extent that the “plaintiffs” made none of their own decisions. Id. at 18 (“Q. And is it your understanding that all the litigation decisions are made by the lawyers and [the funder]? A. Correct.”). All of this caused Judge Connolly to muse about whether third-party litigation funders had “perpetrated a fraud on the court” “designed to shield” themselves “from the potential liability they would otherwise face . . . in litigation.” Judge Connolly ordered the parties to produce documents evincing the extent of the relationship between the funder and the ostensible plaintiffs and plaintiffs sought mandamus to the Federal Circuit. In re: Nimitz Techs. LLC, 2022 WL 1794845, at *3 (Fed. Cir. Dec. 8, 2022), which was denied. Judge Connolly then referred plaintiffs’ attorneys to their bar disciplinary counsel and certain attorneys for the undisclosed entities to the Texas Supreme Court’s Unauthorized Practice of Law Committee. Nimitz Techs. LLC v. CNET Media, Inc., 2023 WL 8187441 (D. Del. Nov. 27, 2023).

Another example was in antitrust litigation brought by Sysco against certain meat suppliers for alleged price-fixing violations. In late 2022, Sysco prepared to settle part of the litigation pending in the Northern District of Illinois and the District of Minnesota. However, unbeknownst to the settling defendant, the litigation funder had been funding the litigation since 2019 (in the amount about $140 million). The litigation funder did not approve the settlement and had it enjoined through arbitration. The funder and Sysco eventually worked to resolve their differences, in part by proposing to substitute the funder for Sysco in the relevant litigations. The Court in the Northern District of Illinois permitted the substitution, reasoning that the funder’s presence “would facilitate the conduct of the litigation.” In re Broiler Chicken Antitrust Litig., 2024 WL 1214568, at *1 (N.D. Ill. Mar. 21, 2024). But the Court in the District of Minnesota took the opposite tack, explaining that the substitution “contravene[ed] public policy favoring party control over litigation and settlements.” In re Pork Antitrust Litig., 2024 WL 2819438, at *2 (D. Minn. June 3, 2024).

The LTA proposes to address these types of situations by mandating transparency, which in the view of its proponents, is essential to starting to bring order to litigation funding and facilitating the public policy goal of encouraging settlements. While the LTA is in a preliminary stage, it’s one to watch for those concerned about litigation funding and focused on the facilitation of settlements.

Guest Post − A 50 State Survey of State Law Concerning Offers of Judgment

By Bexis on September 16, 2024

This guest post is from the colleagues of our Butler Snow bloggers, written by Beth Roper, Megan Donaldson, and Denise Lee. It first appeared in their firm online publication “Pro Te Solutio.” Bexis read it and thought it would make a worthy addition to the Blog, and they graciously agreed. Our authors collaborated to collect the law from all 50 states on offers of Judgment. As always, our guest bloggers deserve all the credit (and any blame) for their efforts.

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Most states have an offer of judgment provision, and many of them are patterned after Federal Rule of Civil Procedure 68 (Maryland, Illinois, New Hampshire, Ohio, Pennsylvania, and Virginia are the exceptions without such provisions). Unlike Fed. R. Civ. P. 68, some states allow either party—not just the defendant—to make an offer of judgment. Even more significantly, a few states also allow a rejected offer to serve as an independent basis for an award of attorney’s fees. Federal courts in diversity cases do not always apply state statutes, but in some cases, these statutes have been deemed substantive and have been applied in federal court. See Spencer v. Ottosen Propellar & Accessories, Inc., 2019 WL 1090776, at *2 (D. Alaska Jan. 15, 2019)) (holding Alaska R. Civ. P. 68 was substantive law and thus to be applied in federal cases based on diversity jurisdictions); Zamani v. Carnes, 2009 WL 2160569, at *3 (N.D. Cal. July 20, 2009) (“Although [Cal. Code. Civ. P. 998] is a state rule, offer of judgment rules appear to be ‘substantive’ for Erie purposes.”); Am. Home Assurance Co. v. Weaver Aggregate Transport, Inc., 89 F. Supp.3d 1294 (M.D. Fla. 2015) (applying the Florida’s offer of judgment statute); Wheatley v. Moe’s Southwest Grill, LLC, 580 F. Supp.2d 1324 (N.D. Ga. 2008) (applying Georgia’s offer of judgment rule).

Recovery of attorney’s fees is one of the most significant factors that increases the value of making an offer of judgment. In this survey, we first address states that allow attorney’s fees after a rejected offer—although some of these statutes only allow for a limited fee collection. We then discuss offers of judgment that are more like Fed. R. Civ. P. 68, permitting awards of costs only.

N.D. Fla. Rejects Post-Removal Attempt to Amend to Defeat Diversity

By Susanna Moldoveanu on September 13, 2024

We wrote a few days ago about a favorable ruling on a state human tissue shield statute in Heitman v. Aziyo Biologics, Inc. (N.D. Fla.). That case gave us another good procedural ruling to share, rejecting a trick we see all too often: an attempt to join a non-diverse defendant post-removal.

The Intersection of Telehealth, Privacy, and Medical Devices

By Eric Alexander on September 12, 2024

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.

Welcome to Hell

By Stephen McConnell on September 11, 2024

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 ….

Erie Doctrine Requires Narrow Interpretation of Florida Human Tissue Shield Statute

By Michelle Yeary on September 10, 2024

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.

Drug & Device Law