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Over the last month, Bexis attended both the Hollingsworth Firm’s annual toxic tort litigation defense seminar and the Lawyers for Civil Justice spring meeting.  Both meetings featured discussions on how the new amendments to Fed. R. Evid. 702 were faring in court.  We’ve also written several blogposts (links below) about favorable applications of the new rule, which became effective December 1, 2024.  The amendments having been in effect now for several months, we decided to see whether they were having the Rules Committee’s desired effect of toughening up judicial consideration of expert testimony under Rule 702.  So we’re taking a more systematic look at the judicial response to the 2023 amendments.

Continue Reading How Are the Recent Rule 702 Amendments Faring in Court?
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Last year Bexis was lead author on a law review article in the Food and Drug Law Journal titled Federal Preemption and the Post-Dobbs Reproductive Freedom Frontier.  The article expands on themes previously raised in this blog, including here, here and here.  It discusses the application of federal preemption under the Food Drug and Cosmetic Act (FDCA) to state-law medication abortion restrictions after Dobbs. The article recognized that, following Dobbs, it was inevitable that FDCA preemption would become embroiled in the abortion controversy. That prediction was accurate.  Today’s decision addresses the impact of preemption on a North Carolina law that imposed significant restrictions on an FDA approved medication taken to terminate a pregnancy.

Continue Reading North Carolina and Post-Dobbs Regulation of Mifepristone
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We’ve written more than once that the recent (effective last December) amendment to Federal Rule of Evidence 702 qualifies as a Very Big Deal. An opinion in the J&J talc multidistrict litigation (MDL) proves that point.  

A little history is in order.  Many, many plaintiffs sued J&J, claiming that its talcum powder caused cancer. The science supporting this claim was pretty flimsy.  Once upon a time, a New Jersey state court judge wrote a lovely opinion taking a hammer and tongs to the plaintiffs’ junk talc science. (We applauded that opinion here.)

Things were a little less lovely in federal court. Judge Wolfson issued a Daubert opinion that did not perform as much junk science removal as the state court judge did. (Yes, yes – we know we’re not supposed to call them Daubert opinions anymore. We’re supposed to stick with Rule 702.  But we’re doing history right now, and the Daubert label works as a matter of history.) We didn’t like the MDL court’s opinion nearly as much as the state court opinion.  For now, we’ll leave it at this: it could have been better.  But we’ll let bygones be bygones, and now Judge Wolfson is gone. She retired. Judge Shipp took over the case. 

(Here is more history, but of a different nature. One of the plaintiff talc experts has been accused of doing utterly bogus research. J&J filed a lawsuit alleging business libel, and that case is pending. We wrote about that here.)

The defendants argued to Judge Shipp that the Daubert opinion authored by Judge Wolfson should be looked at again because (1) many years had gone by since that ruling and the restarting of the MDL (due to interim bankruptcy stays), (2) science had evolved, and (3) Rule 702 had changed. 

The plaintiffs’ must have enjoyed the original Daubert opinion, because they opposed any relook at it. The plaintiffs must have enjoyed rather less Judge Shipp’s reopening of the Rule 702 issue.  Judge Shipp was persuaded that new Rule 702 and new science made “a full refining of Daubert motions appropriate.”  The plaintiffs filed a motion to reconsider that text order. Judge Shipp denied the motion to reconsider. In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, Civil Action No. 16-2738 (MAS) (D.N.J. April 20, 2024). 

In denying reconsideration, the court made clear that it was not throwing away Judge Wolfson’s prior Daubert ruling – yet. But fresh eyes, guided by new science and new Rule 702, were in order.  Indeed, Judge Wolfson’s original opinion contemplated “that her Daubert rulings may be subject to change as new scientific knowledge propagated over time.”  

The plaintiffs argued that the old Daubert rulings must be frozen in place because they were the “law of the case.”  But “interlocutory orders remain open to trial court reconsideration, and do not constitute the law of the case.”  The plaintiffs also argued that a full re-review of Rule 702 issues was unnecessary because the amendment “did not change evidentiary standards, but clarified them.”  The MDL court flipped the script, reasoning that the “fact that Rule 702 is not a change in the law but a clarification is precisely why it would be inappropriate for this Court to preclude Defendants from challenging this Court’s previous Daubert holdings.”  (Emphasis in original.) The amendment to Rule 702 clarified that the proponent of expert testimony bears the burden of showing that the expert opinions past muster. According to the MDL court, “[t]hese clarifications not only guide courts in the future, but outline a consistent and concerning misapplication of Rule 702 by courts in the past.”  Accordingly, the MDL court directed the parties to brief whether the previous Daubert opinion “demonstrably fails to adhere to Rule 702 as clarified by the 2023 amendments,” and whether “new science is shown to directly contradict or challenge Judge Wolfson’s previous findings.”  

John Adams said that “facts are stubborn things”. But courts needn’t be stubborn. Sometimes a redo is necessary. 

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If you have a good memory, the title of today’s post may seem familiar.  That’s because about sixteen months ago, we told you about the appellate court decision in Oregon that reached this conclusion.  Now it is official.  The Oregon Supreme Court has weighed in and agrees that under Oregon’s product liability statute, hospitals are sellers of the prescription drugs they administer and can be held strictly liable as such.  Providence Health System-Oregon v. Brown, 372 Or. 225, — P.3d – (2024).    

The decision is singularly focused on the text and context of ORS 39.920 – a 1979 Oregon statute that establishes strict products liability for “one who sells or leases any product in a defective condition unreasonably dangerous . . . if the seller or lessor is engaged in the business of selling or leasing such a product.”  Id. at 231.  ORS 39.290 further says that it should be construed in accordance with the Restatement (Second) of Torts §402A and its comments.  The court’s decision turned on the definition of “sells” and “engaged in the business of selling.”

As it turns out, there are a variety of both common and legal definitions of “sell” – all of which involve the “transfer of a product to another in exchange for money or other valuable consideration.”  Id. at 233.  The hospital defendant urged definitions from Black’s and Oregon’s UCC that include transfer of ownership or passing of title and argued that by supplying or administering a drug, it was not “selling” that drug.  Id. at 233-234.  The court concluded that defining a sale as the transfer of the “full panoply” of rights of ownership, which include the ability to transfer the product to someone else, is too limited.  Id. at 234-235.  In part this decision was based on the inclusion of “leases” in ORS 39.290 and in part on the fact that “ownership” and “title” are not concepts included in §402A.  Rather, applying an example from the comments to §402A, the court compared the hospital administering an intravenous drug to a beauty shop who can be sued in strict liability for application of a “permanent wave solution.” 

Having decided that administering the drug was a sale, the court turned to whether the hospital was “engaged in the business of selling” prescription drugs.  Here the court concluded that because the hospital’s business regularly involved transferring products to others in exchange for consideration, it was “engaged in the business of selling.”  Again, turning to §402A, the court points out that comment f states “it is not necessary that the seller be engaged solely in the business of selling such products.”  Id. at 238.  Meaning one can be in the business of selling even when the sale is ancillary to providing a service, such as a movie theater selling popcorn.  Rather, the primary limitation on being engaged in the business of selling is being an isolated seller, such as a homemaker who sells the occasional jar of jam to a neighbor.  Which may be an even more outdate example than the “permanent wave.” 

Moving beyond the text of the statute, the court looked to case law for context.  Considering that the vast majority of the national case law interprets §402A as not applying to hospitals, we would have expected this to be where the tide turned.  However, because ORS 39.290 was passed back in 1979, the court held that the great majority of all the nationwide precedent is irrelevant, since it post-dated 1979, and thus could not have a bearing on legislative intent.  Id. at 244.  And, as for the few older cases, the court ignored those because it had no evidence that the legislature was aware of them.  As a result of this selective use and non-use of the majority rule, the Oregon legislature was presumed to have “intended” to place Oregon in a distinct minority position when nothing in the record supported that “intent” either. 

In short, and for now, hospitals are subject to strict liability in prescription medical product litigation.  That is unless and until the legislature acts to protect them from this rather bizarrely pro-plaintiff result.

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We continue to be cautiously optimistic that the recent amendments to Fed. R. Evid. 702 – enacted because too many courts had been too flaccid for too long in admitting dubious “expert” testimony – will actually improve things in the courtroom.  Our latest data point is In re Paraquat Products Liability Litigation, ___ F. Supp.3d ___, 2024 WL 1659687 (S.D. Ill. April 17, 2024).  While Paraquat is not drug/device litigation (the substance is a widely used herbicide), the Rule 702 analysis has broad applicability – as demonstrated by the decision’s reliance (in part) on the Acetaminophen decision that we discussed here.

Continue Reading Amended Rule 702 – Eradicates Invasive Experts on Contact
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The California Supreme Court has granted review in Gilead Life Sciences v. Superior Court, the case in which the California Court of Appeal ruled that the defendant could be liable to users of one drug for alleged negligence in connection with a different drug, even while admitting that the drug they actually used was not defective.  As we explained here and here, the plaintiffs in Gilead used HIV drugs known as “TDF.”  But rather than allege that TDF drugs were defective, the plaintiffs asserted that that the defendant was negligent in failing to bring a different, but allegedly safer HIV drug (“TAF”) to market sooner. 

It is an unprecedented theory of liability.  Product liability law in California (and most everywhere else) has always required proof of a product defect.  The Gilead Sciences opinion did away with that; and in its place, the Court of Appeal imposed a free-floating duty to innovate—a duty of reasonable care when a manufacturer has invented “what it knows is a safer, and at least equally effective, alternative to a prescription drug that it is currently selling and that is not shown to be defective.”  Gilead Sciences, Inc. v. Superior Court, No. A165558, 2024 Cal. App. LEXIS 14, at *14 (Cal. Ct. App. Jan. 9, 2024) (review granted). 

The grant of review is obviously a good development.  Although the Court of Appeal attempted to portray its newly created duty as “narrow,” we always had our doubts. 

Apparently, the California Supreme Court has its doubts too, and while the ultimate outcome remains to be seen, arguments in favor of rejecting the new duty and restoring the law are strong.  In our defense-biased view, the defendant’s Petition for Review was exceptionally persuasive. 

Equally telling was the extraordinary response by amici urging the California Supreme Court to grant review —twelve amicus letters that we know of, speaking for approximately 50 companies, non-profits, individuals, and trade groups.  Here are some snippets, the first from about 15 other drug and medical device manufacturers: 

Contrary to the Court of Appeal’s intent, its decision will likely harm innovation—and ultimately patients and consumers—by encouraging companies not to invest in research and development for fear of being liable for not more quickly bringing to market what may turn out to be an incremental improvement to an existing product. . . . [L]itigants will surely seek to extend the decision’s reasoning to other products; and regardless, the mere possibility that it might apply to other industries will immediately chill socially desirable, innovative behavior.

And this from multiple trade associations, such as PhRMA:

No jury, even with the benefit of hindsight, could reasonably discern when a manufacturer ‘knew’ its invention was ‘safer and at least equally as effective,’ triggering a duty. . . . [L]ife sciences companies often develop multiple medications in parallel, and companies must make complicated strategic decisions about where to devote resources based on limited information. . . .  A company does not know with any measure of clarity during early stages of the development process . . . that a medicine is ‘safer’ and ‘at least as equally effective,’ and thus cannot be fairly subject to liability for decisions made at that time.

Of course, the new duty could easily be extended beyond prescription drugs, as explained by the National Association of Manufacturers, the Alliance for Automotive Innovation, and other sellers of consumer products:    

Nothing in the decision below applies exclusively to the pharmaceutical context, nor would it be difficult for other plaintiffs to copy the theory . . . .  Innovation is a necessity in every business.  But now, discarded ideas and prototypes, rather than being stepping stones on the path to success, could become the basis of lawsuits.

One tech startup in the autonomous automobile space chimed in:    

The ruling will discourage continuous product improvement, deter bringing new products to market, and disrupt the ecosystem in which innovation in the technology sector develops.

Economists have a view on this, and it is not favorable, according to the International Center for Law & Economics:

If upheld, this new duty of care would significantly disincentivize pharmaceutical innovation by allowing juries to second-guess complex scientific and business decisions about which potential drugs to prioritize and when to bring them to market. . . .  Perversely, this would deprive the public of lifesaving and less costly new medicines.  And the prospective harm . . . is not limited only to the pharmaceutical industry. . . .  Although conventional wisdom has often held otherwise, economists generally dispute the notion that companies have an incentive to unilaterally suppress innovation for economic gain.

There was too much material in the amicus letters to share here.  We will finish, however, with the view of multiple advocates (other than contingency-fee plaintiffs’ lawyers) for patients and underserved communities, such as ALLvanza, the Global Coalition on Aging, and the HIV and Hepatitis Policy Institute.  These organizations and their co-amici bemoaned the opinion’s chilling effect on drug development and resulting harm to health:

This unprecedented legal theory stands to chill the development of a future generation of drugs, including much-needed potential treatments and cures for a wide range of diseases. . . .  In unprecedented fashion, this new litigation risk attaches to drugs that are concededly safe and effective.  In the vein of no good deed goes unpunished, a manufacturer could face potential liability for undertaking rigorous scientific research and pursuing expensive clinical trials aimed at developing the next generation of therapeutic treatments.

The plaintiffs’ response was that amici were bought and paid for by the industry and that the Court of Appeal’s new duty was nothing more than an ordinary duty to exercise reasonable care.  Again, we are not so sure.  We understand the breadth of tort duties, but there are limits. 

The appeal will now proceed to full-blown briefing.  We will keep you posted.  

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We recently recapped the law relating to when experts are allowed to opine on what was in the head of another and how a pending Supreme Court criminal case might affect things.  In our area, this issue comes up most frequently in the context of plaintiff experts trying to offer their spin about how the purportedly nefarious machinations of drug and device manufacturers affected decisions on the design, labeling, testing, etc., of the product at issue in the case or some argued alternative feasible design.  Almost as often, where the prescribing physician is not deposed or where the plaintiff elects not to ask the prescriber the relevant direct question about proposed changes to the labeling or to the known risk-benefit information on the product, plaintiff experts like to speculate on the impact that information would have had on the decision making of a particular physician they do not know.  Not only is it clearly the plaintiff’s burden to offer evidence from the prescriber herself that connects to the precise patient, point in time, and proposed additional information, but weighing this evidence is for a jury (if the judge lets it get that far) not an expert.  Still, many courts tend to muck up the handling of this issue, in part, we think, because of a general hesitancy to grant summary judgment on proximate cause for failure to warn in cases where the plaintiff has a plausible injury.  This dynamic seems to play out fairly often in cases that have been pending for a long time.

McCoy v. Depuy Orthopaedics, Inc., No. 22-CV-2075 JLS (SBC), 2024 U.S. Dist. LEXIS 72108 (S.D. Cal. Apr. 19, 2024), was certainly pending for a long time before the ruling on summary judgment and expert motions two weeks ago.  It was direct filed in late 2011 in a notorious hip implant MDL and languished there for eleven years before getting sent to the “home” district court, which issued the decision we are discussing about 16 months later.  We will not summarize all the questionable rulings from that MDL, or even those that featured in the well-publicized Fifth Circuit reversal of a runaway verdict, but plenty of them related to leniency toward plaintiff experts.  Some of those plaintiff experts were touted as working for free, but actually got paid.  More broadly applicable was the Fifth Circuit’s rejection of the significance the trial court had placed on expert testimony on what a “reasonable physician” would do with additional information, including allowing it to trump contrary testimony from the actual prescriber. One of the things that has happened since that MDL issued rulings on the admissibility of testimony from several generic and recurring experts is that Rule 702 was amended to emphasize the trial court’s gatekeeping function and that the burden is on the proponent of challenged expert evidence to show that it meets the standards for admissibility.  As we highlighted earlier this week in the context of a non-remanded knee implant case,

[M]any courts have held that the critical questions of the sufficiency of an expert’s basis, and the application of the expert’s methodology, are questions of weight and not admissibility.  These rulings are an incorrect application of Rules 702 and 104(a).

Sprafka v. Medical Device Business Services, Inc., 2024 WL 1269226, at *2 (D. Minn. March 26, 2024) (quoting Advisory Committee Note to 2023 Amendment).

We raise all this not just for purposes of making our segue seamless, but to highlight issues with the modern long-lived MDL.  A direct-filed case sits around for a decade.  It inherits Daubert and other rulings that may have been disfavored by an appellate decision or impacted by a change in the rules, yet the rulings will have some force if not be law of the case even when the case ends up pending in another circuit.  For McCoy and hundreds of cases in the same boat, there was an order requiring the filing of dispositive and expert motions a few weeks before remand to a district court that would set its own pretrial schedule and possibly allow additional discovery.  Experts named back in the MDL may no longer be around for the remand case come trial.  In McCoy, one of the plaintiff experts had been disqualified due to a conflict, so she was allowed to swap in a new one.  In short, this sort of protracted case history make for messy motions practice and the messiness tends to work in the favor of the plaintiff, particularly when the MDL from whence the case came was so overtly plaintiff friendly.

We will not try to unpack all of the issues addressed in McCoy, which included denying a motion for summary judgment as untimely and then finding genuine issues of material fact would have led to a denial on the merits anyway.  One of the summary judgment arguments that the manufacturer offered was that the implanting surgeon’s own testimony was insufficient to carry plaintiff’s burden on proximate cause for failure to warn.  2024 U.S. Dist. LEXIS 72108, *21.  Without ever mentioning “burden” or what plaintiff contended should have been added to the device’s IFU before the implant, the court approached the issue as if it were incumbent on the defendant to rule out the possibility that any additional information could have affected the prescriber in any way.  That, of course, is the wrong formulation of the question.  As such, the court’s linkage of the prescriber having read some promotional materials and some version of the IFU “at some point” and that he tended to get information from the “hip and knee replacement community” to the conclusion that it was possible that a “stronger warning” would have reached the prescriber through some route and changed his decision to use the particular device was based on an overly lenient standard.  Id. at *22-23.  Plaintiff’s expert evidence on what additional warning was required when and how that would have impacted the prescriber or some hypothetical reasonable prescriber was not part of the summary judgment analysis.

The rest of the McCoy decision addressed challenges to five plaintiff’s experts and we will discuss two of them, both frequent flyers.  The above quote from Sprafka on the amendment to Rule 702 related to a challenge to a biomedical engineering expert named Mari Truman, who was also challenged in McCoy on some facially similar opinions, albeit on a different device for a different surgery.  To start, the court allowed Ms. Truman to opine on case-specific medical causation, rejecting a challenge to qualifications in part because the Pinnacle MDL found a biomechanical engineer with different experience to be qualified.  Id. at *36-37.  Without mentioning burden, the court also found Ms. Truman’s specific causation opinion to be reliable even though she had no testing or data on plaintiff’s specific device to link up to her general theory, relying instead on plaintiff’s clinical symptoms to rule in a role for the purported defect in the device.  Id. at *37-38.  This was not even a differential diagnosis (by someone who is not a physician).  The court also rejected challenges to Ms. Truman’s opinions on the adequacy of warnings and testing, without mentioning burden or providing many details on her actual opinions, what the IFU said, or what testing was actually done.

When it came to Ms. Truman’s opinion on how different warnings would affect physicians in general—something that probably should not have been an issue for expert testimony at all—the court did consider burden.  (It also considered it in rejecting a challenge to her design defect and alternative design opinions.)  The analysis, however, was limited to qualifications, perhaps overly so.  The court rightly noted “courts treat warning causation opinions from experts not involved in medicine or a plaintiff’s medical car skeptically,” dropping a footnote that cited three cases that also happen to feature in the caselaw on expert opinions on corporate intentId. at *42 & n.13.  However, each of these cases actually involved the exclusion of opinions from medical doctors, specifically well-known plaintiff experts Parisian, Furberg, and Gueriguian.  Indeed, the full quote from In re Diet Drugs and Rezulin, included with some ellipses in the footnote, is that the excluded warnings causation opinion is “purely speculative and not based on scientific knowledge.”  (Emphasis added) So, while McCoy found that plaintiff did not establish the qualifications for Ms. Truman to opine in this area and that her opinions “seem to amount only to speculation,” this is not merely an issue of insufficient qualifications.  Id. at *42.  A similar dynamic played out in allowing Ms. Truman to opine on “information available to [defendants], what they should have known based on that information, and what actions such knowledge should have prompted.”  Id. at *46.  Unless the third part is linked to defined regulatory or industry standards, the resulting testimony is going to be personal opinion not expert opinion.  Similarly, the “should have” testimony is invariably an excuse to inject speculation that the defendant’s failure to do what the expert would have done was because of some improper motive, typically to place profits over safety.

McCoy also permitted Dr, Kessler, a former FDA commissioner who seems to have never met a medical device in litigation that he liked, to opine on purported ethical responsibilities and “what Defendants should have known and done based on his interpretation of internal records and the literature,” among other topics.  As to the former subject, the court relied on the Pinnacle MDL’s acceptance of “expert testimony regarding applicable ethical standards.”  Id. at *51.  There is a whole line of MDL decisions, again going back to In re Diet Drugs and Rezulin, that excludes ethical responsibility opinions against drug and device companies, even when offered by former FDA officials and other prominent healthcare professionals and purportedly grounded in regulatory or industry standards.  Among the obvious problems with testimony on purported ethical standards in a court of law is that it “merely tell[s] the jury what result to reach, somewhat in the manner of the oath-helpers of an earlier day.”  Fed. R. Evid. 704 advisory committee note.  As to the latter subject, the subjective “interpretation of internal records” that someone else created and the expert has only seen in connection with litigation will inevitably stray into opinions of why some possible course of action was not chosen.  That is mindreading and argument, not using an “expert’s scientific, technical, or other specialized knowledge [to] help the trier of fact to understand the evidence or to determine a fact in issue.”  Fed. R. Evid. 702(a).  It is also potentially quite impactful on the jury when offered from the witness stand by an expert, as opposed to from a lectern by an advocating attorney.  The proper course is to let the lawyer argue and the jury evaluate the evidence without allowing experts to say what was in the corporate defendant’s figurative head and whether it behaved ethically.

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Smith v. Angiodynamics, Inc., 2024 U.S. Dist. LEXIS 73561 (M.D. Alabama April 23, 2024), offers the veritable mixed bag of rulings. The plaintiff alleged that an implanted vascular device fractured, resulting in pieces of the device migrating to the plaintiff’s heart. The plaintiff underwent surgery to remove the fragments.  The plaintiff’s lawsuit included claims for (1) violation of the Alabama Extended Manufacturer’s Liability Doctrine (AEMLD); (2) negligence; (3) breach of warranties; and (4) wantonness. The defendant filed a motion to dismiss all of the claims.  The plaintiff conceded that the warranty claims were goners, but otherwise resisted the motion.  The court ended up not dismissing any of the claims (except the conceded warranty causes of action), but said a few things that might comfort a flinty defense hack’s heart. 

The most significant and positive (from the defense hack heart perspective) portion of the Smith opinion provided an affirmative answer to whether Restatement (Second) of Torts section 402A, Comment k principles apply to medical devices in addition to drugs. Comment k calls off strict liability claims against “unavoidably unsafe” products.  In law school, we learned that explosives and circus lions were unavoidably unsafe. In practice, we learned that prescription drugs also fall into that category.  But what about medical devices?  

The Smith court held that comment k can apply to medical devices, which is the majority rule.  That’s good.  But the court also was “unwilling to apply a blanket rule of application across all medical devices.”  Thus, the court held that Comment k applies only on a case-by-case basis, which is not so good, but is also the majority rule.  Because the Smith court could not “discern at this early stage of the proceedings whether Comment k should apply,” it denied the motion to dismiss the design defect claim.  Of course, we would have called it a day after determining that the medical device in question was available only via prescription. Under the DDL blog worldview, Comment k would apply, so goodbye to strict liability design defect.  But since (checking our mail) no one has nominated us to an Article III judgeship, our highly biased opinion matters hardly at all. 

Also notable in the Smith decision is the holding that Comment k applies to negligence and wantonness (an Alabama peculiarity) claims, which is a less common ruling.  The wantonness claim is not subsumed by the AEMLD, but because it is still propelled in this case by an assertion that “the product at issue is defective,” Comment k should apply here. Nevertheless, because the Smith court by its own account “punts the issue of Comment k under the AEMLD to a later stage … the issue will also be punted as to Smith’s defective design claims brought under the theories of negligence and wanton mess.”   That’s a lot of punting in Alabama. We doubt that Nick Saban would approve. 

The Smith court held that the learned intermediary rule applies to medical devices, which seems an obvious enough point.  But the Smith court concluded that the plaintiff pleaded enough non-physician-specific smoke that the court denied dismissal on that ground. There was reference to underreporting of adverse events and provision of “incomplete, insufficient, and misleading information to physicians.”  We agree with the defendant that such allegations were too general, vague, and conclusory to carry the day for the plaintiff, but the Smith court saw that issue differently. 

We’re not huge fans of The Grateful Dead, but for some reason the lyrics to “Alabama Getaway” are ringing through the DDL noggin right now.  

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Oh, so many years ago we started calling cases that prevent innovator liability and preempt generic liability the “one-two punch.”  But really any decision that strikes a substantive blow and follows it up with a preemption jab is OK in our books.  And that is just what happened in Harris v. Medtronic Inc., 2024 WL 1747385 (D. Minn. Apr. 3, 2024). 

Plaintiff brought a putative class action on behalf of himself and others who received an implantable cardioverter defibrillator (ICD) manufactured after a certain date by the defendant.  The ICDs at issue were voluntarily recalled due to a potential for the devices to deliver a low or no energy output when high voltage therapy was needed.  The FDA issued a notice about the recall advising that the ICDs should not be replaced for this issue, which would necessitate surgery and further risks. Rather the issue could be addressed with reprogramming and monitoring.  Id. at *1-2.  Plaintiff files claims for consumer protection and products liability alleging that his ICD causes him discomfort and blood clots in his arm, that he is “at risk of additional extensive medical procedures,” and he spent money to purchase the ICD.  Id. at *2.

First up, a direct hit due to lack of a cognizable injury, and thus standing.  To have standing, plaintiff has to have suffered an injury-in-fact that is “concrete and particularized” and not “conjectural or hypothetical.”  Id. at *3.  In the case of a claim of a defective product, there is no injury-in-fact “where the alleged defect has not manifested itself in the product [plaintiff] own[s].”  Id.  It is not enough for there to be a risk of a possible malfunction sometime in the future.  Here, plaintiff conceded that his ICD had never malfunctioned.  Moreover, plaintiff did not dispute that the “risk” could be resolved through external reprogramming, thereby eliminating the risk without the need for “additional extensive medical procedures.”  Id. at *3-4.

Despite the Eighth Circuit decisions holding explicitly that absent a manifestation of the defect plaintiff has no standing, plaintiff argued his case was distinguishable because “demonstrating a high probability of a severe injury is sufficient to state an injury-in-fact.”  Id. at *4.  Let’s call this the “super risk” theory.  Plaintiff offered zero legal support for his “super risk” theory.  That’s because there is none.  For that reason alone, the court declined to depart from binding precedent.  In addition, plaintiff would not have met his own “super risk” standard.  The FDA described the likelihood of a reduced or no-energy output as a “rare potential.”  So, at most, plaintiff has alleged a “rare potential” of a defect, not a “high probability of severe injury.” 

Nor were plaintiff’s claimed injuries–discomfort and blood clots and future medical procedures—traceable to the alleged product defect–failure to produce sufficient voltage.  Id. at *5.  Primarily because plaintiff’s ICD has never malfunctioned, but also because the FDA specifically advised against surgical intervention in favor of external reprogramming.  Id. Without a causal connection between the alleged injury and alleged defect, plaintiff has no standing. 

While plaintiff was still reeling from that first hit, the court landed its preemption punch.  The ICD was subject to premarket approval (PMA).  Therefore, plaintiff’s claims are subject to Riegel preemption.  That is, plaintiff’s claim must “parallel” federal requirements rather than impose “additional” requirements.  Therefore, the claim must involve conduct that violates the FDCA and plaintiff must plead a deviation from federal requirements with “sufficient specificity.”  Id. at *6.  Where plaintiff’s claims attack the safety of the device and the adequacy of the FDA-approved warnings, preemption is generally unavoidable. 

Plaintiff’s first claims were for violations of consumer protection statutes, unjust enrichment, and breach of warranties.  All of which were premised on allegations that defendant misrepresented the safety and effectiveness of the ICD.  To succeed on these claims, plaintiff would have to convince a jury that the device was in fact not safe and effective which would be in direct conflict with FDA’s approval of the device through the PMA process.  Id. at *7.  Hence, not parallel claims.

Plaintiff also brought manufacturing and design defect claims but failed to “adequately allege[] a specific violation of the device’s PMA process.” Id.  Plaintiff did not even mention the PMA process in the complaint, much less plead a deviation from it.  However, since this dismissal is based on conclusory allegations, the court gave plaintiff an opportunity to replead his manufacturing and design defect claims.  That’s a problem for this would-be class representative, since more detail, particularly as to unit-specific manufacturing defects, tends to defeat class certification. But, even if he can “beef up” his allegations, standing remains a punch plaintiff needs to dodge.   

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As we’ve discussed, such as here, Fed. R. Civ. P. 702 was amended in late 2023, because the Civil Rules Advisory Committee concluded that too many courts were erroneously admitting expert testimony that proponents had not established was reliable.  It does appear that at least some courts are cracking down.  Here’s one from an Eighth Circuit court, which is significant since the Eighth Circuit was one of the worst offenders under the prior version of Rule 702.

Continue Reading Frequent Flier P-Side Expert Excluded Under Amended Rule 702