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For any of our loyal readers looking to start the New Year with a healthy helping of CLE credit, a friendly reminder that four of your bloggers – Bexis, Steven Boranian, Stephen McConnell, and Lisa Baird – will be presenting a free 90-minute CLE webinar on “The Good, the Bad and the Ugly: The best and worst drug/medical device decisions of 2023” on Thursday, January 16th at 12 p.m. EST. The webinar will provide further insight and analysis on the cases featured in our posts on the worst decisions and best decisions of the past year.

This program is presumptively approved for 1.5 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.

Additionally, please note that CLE credit for on-demand viewing is only available in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Credit availability expires two years from the date of the live program. In order to receive CLE credit, you will need to notify Learning & Development CLE Attendance once you have viewed the program on-demand. 

The program is free and open to anyone interested in tuning in, but you have to sign up in advance here.

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Every time we read an order about “pre-approval” defects in prescription drugs, we stop to scratch our heads.  It is not because we are easily confused, at least not on most days.  No, we pause to ponder what exactly a “pre-approval” defect is and how a company can be held to answer for an alleged defect in a product’s design or in its warnings before the product is approved, let alone marketed and used to treat a patient. 

“Pre-approval” defect is a legal construct invented by plaintiffs’ lawyers to dodge federal preemption.  When it comes to design defect, the signpost is Mutual Pharma v. Bartlett, where the Supreme Court held that federal law preempts state law design defect claims involving a generic drug because the manufacturer could not have changed the design without the FDA’s pre-approval.  That makes it impossible to comply with state and federal requirements at the same time—thus preemption.  Cases like the Sixth Circuit’s opinion in Yates v. Ortho-McNeil extended that to innovator products, on the ironclad reasoning that a manufacturer of an innovator product cannot change the product’s design without FDA approval any more than a generic manufacturer can. 

The latest plaintiffs to use claims of “pre-approval” defect to avoid preemption (successfully, for now) are the plaintiffs in the Suboxone Film MDL, where they allege that suboxone film which dissolves under the tongue caused dental issues.  Under Bartlett, federal law should preempt any design defect claim, since the defendant could not have altered the product design without FDA approval.  To get around that, though, the plaintiffs argued that federal law did not prevent the defendant from proposing a different design before FDA approval.  In re Suboxone Film Prods. Liab. Litig., No. 24-md-3092, 2024 WL 5264278, at *8 (N.D. Ohio Dec. 31, 2024).  As an example of how the defendant could have designed a safer product, the plaintiffs cited a drug with the same active ingredient, but as an injectable gel—i.e., a different product.  Id. at *11. 

This is a “pre-approval” defect claim, and you can see why it makes no sense.  This “pre-approval” claim is merely a claim that, under state law, the manufacturer should never have sold the product in its approved form.  But, the FDA, under federal law, said that it could. 

State law should have given way.  But it didn’t, at least not for now.  The district court dedicated an entire section of its order to the presumption against preemption (you can see the smoke coming out of Bexis’ ears now).  It also rejected Yates as precedent because the Yates opinion noted that results “might differ ‘in some circumstances’” and because the court found older opinions that Yates left untouched to be more persuasive.  Id. at *9-*10.  The district court also said that no other circuit has followed Yates, an assertion that we have not verified.  Regardless, we reported just over a year ago that preemption of “pre-approval” design defect claims was a majority position.  We doubt that has changed. 

The district court therefore denied the defendant’s motion to dismiss on pre-approval design defect, but it granted the motion on “post-approval” design, under which the plaintiffs alleged that the product’s design was defective after the FDA approved the product.  This of course is a claim that the defendant should “stop selling” a federally approved drug in order to comply with state law, which is obviously preempted under Bartlett.  The district court correctly so held.  Id. at *11. 

That brings us to the plaintiff’s warnings based claims, where they alleged that the defendant did not adequately warn of adverse dental effects until a label change in June 2022.  If you thought “pre-approval” design defect claims were questionable, then “pre-approval” failure-to-warn claims are downright nonsense.  There is no duty to warn of risks in products that are not yet being sold, and the FDA is the final arbiter of what prescription drug labeling can and cannot say once products enter the market.  Under Supreme Court precedent (in Levine v. Wyeth, Pliva v. Mensing, Mutual Pharma v. Bartlett, and Merck v. Albrecht), there is only one exception to federal preemption under these circumstances—when the plaintiff can show that “newly acquired information” would have allowed the defendant to unilaterally strengthen its label under the FDA’s Changes Being Effected (or “CBE”) regulation. 

And the CBE regulation does not apply pre-approval.  So how can there be a “pre-approval” failure to warn claim?  There can’t be. 

This district court could have said that, but instead it wrote that because the plaintiff did not use the product “before its approval,” the court “need not address whether FDA approval of the label forecloses any warning claim arising before then.”  Id. at *12.  We are not sure why the court felt compelled to say this.  No one used the product before it was approved, and no failure-to-warn claim could have arisen before approval. 

The real controversy was on the garden-variety, “post-approval” failure-to-warn claim under which the plaintiffs argued that a December 2022 publication provided “newly acquired information” on adverse dental effects that could have supported a unilateral label change, thus avoiding preemption.  The defendant countered that it had already updated the label to include adverse dental effects in June 2022 and that the December publication revealed nothing new.  The district court, however, ruled that the plaintiffs had alleged newly acquired information sufficient to survive a motion to dismiss.  Perhaps the outcome will be different on a more-developed record. 

The concept of “pre-approval” claims still makes our heads hurt, but we have written so much on them by now that our views are firm.  A “pre-approval” design defect claim is just a claim that the defendant never should have sold the approved product.  And a “pre-approval” failure-to-warn claim is merely a claim that the drug labeling, as approved by the FDA, was not adequate.  No mental gymnastics are required to find such claims preempted. 

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“Off label use” is a bit of an odd thing.  The FDA does not regulate the practice of medicine, but it does get involved in the labeling of medical devices and pharmaceuticals through the applicable pre-marketing review processes, and those labels identify the use (or uses) intended for that medical product.  That use (or those uses) are ones for which there is reasonable evidence of safety and efficacy, in the FDA’s estimation, but the practice of medicine moves faster than the regulatory process.  Once an approved device or drug is available, doctors can prescribe it for any purpose they believe is warranted—regardless of what the label says.  Indeed, sometimes it is the medical standard of care to prescribe a medical product for uses other than what is stated on the label.

But when a use is off-label, what role can or should a manufacturer have in discussions with physicians or medical debate about those off-label uses?  The idea of manufacturers paying for ads that say “use our ProductTM for condition X” when the FDA has only reviewed the clinical data and authorized the ProductTM to be labeled for condition Y makes many uneasy.  But what if using Product for condition Y has become the standard of care—can the manufacturer communicate with doctors about that?  What if there are quality, published scientific articles about that unapproved use?  Can the manufacturer unilaterally send out copies?  Can the manufacturer provide copies of that quality, published scientific article, but only if a physician asks for it? 

The FDA has—shall we say—fluctuated over time about what is, or is not, permissible for a manufacturer to say or do with respect to off-label uses (or, in its parlance, “unapproved uses”).  There was an earlier final guidance issued in 2009, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.”   

That was replaced in 2014 with a draft guidance “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices.” 

That March 2014 draft guidance was replaced by a revised draft guidance in October 2023 (“2023 Draft Guidance”). 

And now, on Monday, January 6, 2025, the FDA issued its new final guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products:  Questions and Answers” (“2025 Final Guidance”) to describe its

enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm’s approved/cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients.  

The Federal Register notice is here.

Overall, the framework of the 2025 Final Guidance will be familiar.  It describes certain types of manufacturer-initiated communications with health care providers about off-label uses that should not result in enforcement action by the FDA, which clearly suggests that other types of communications about off-label uses (even if truthful and not misleading) are potentially fair game for FDA enforcement.

In particular, the 2025 Final Rule attempts to articulate how a manufacturer of an approved/cleared medical product can stay out of regulatory trouble by providing a Q&A series about what to do, or not to do.  For example, any manufacturer-initiated communications to physicians about off-label uses should be “scientifically sound” and of a certain type (published scientific or medical journal articles, clinical practice guidelines, reference texts, or digital clinical practice resources).  They also must be accompanied by the current approved labeling, additional statements (about the approved use, that the unapproved use has not been approved by FDA, and that the safety and effectiveness of the medical product for the unapproved use(s) has not been established); and relevant warnings and contraindications; and so on.

There are, of course, First Amendment questions raised by any attempts to regulate speech about off-label use, and those questions remain present with the 2025 Final Guidance as well.  If the manufacturer’s speech about the use of ProductTM for Condition Y is not false or misleading in any respect, can a regulation restricting that speech be consistent with the First Amendment?  That is a topic near-and-dear to the heart of Bexis, as covered in numerous posts. 

The 2025 Final Guidance does acknowledge, at least to some degree, that there are First Amendment implications raised by a regulatory guidance directed at speech.  But there is nothing really new from the Agency on the First Amendment issue in the 2025 Final Guidance.  Mostly, the 2025 Final Guidance cites the FDA’s own January 2017 Memorandum, “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” which was pretty well picked apart in this post.

More recently, Bexis has suggested that Loper Bright provides a pathway for courts to independently examine the statutory and regulatory framework (house of cards?) that the FDA traditionally has used to justify enforcement of its policies about off-label promotion, and decide for themselves whether they provide the authority the FDA says it has.  The 2025 Final Guidance takes a stab at articulating the relevant “FDA Authorities” that empower its oversight of information about off-label uses, but it is no more compelling than the Agency’s earlier justification attempts.  Compare 2025 Final Guidance at 7 & fn. 13-16 with 2023 Draft Guidance at 2 & fn. 3.

Bexis also has posited that the FDA exceeds its authority in attempting to regulate information about off-label uses, and thus is vulnerable to a legal challenge to its regulatory guidances, in Is the FDA’s Off-Label Speech Proposal Infected with the Ultra Vires?  Nothing in the 2025 Final Guidance seems to address or anticipate Loper Bright-based challenges, however.

Off label will never be off topic on this blog, so undoubtedly there will be more to come as we ruminate some more now that the 2025 Final Guidance finally is here.

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There have been some famous law review articles, such as R. Coase, “The Problem of Social Cost,” J. of Law and Economics (1960), and S. Warren & L. Brandeis, “The Right to Privacy,” Harvard L. Rev. (1890).  Those articles made waves when they came out, and they were cited endlessly. But when was the last time you read them?  An article might have been brilliant and path-breaking, but that does not mean it is actually useful for one’s day to day practice. By contrast, when we worked in the U.S. Attorney’s Office, the Georgetown Law Journal Annual Review of Criminal Procedure was, along with the Federal Rules of Criminal Procedure, the most indispensable item in our brief bag. 

Today we are pleased to recommend a law review article that is both brilliant and useful. M. Behrens & A. Trask, “Federal Rule of Evidence 702: A History and Guide to the 2023 Amendments Governing Expert Evidence,” 12 Texas A&M L. Rev. (2024), should find a place on the desks and in the hearts of defense lawyers looking to ward off plaintiff expert junk science. The authors are two heroes of the defense bar who practice at Shook Hardy and work with Lawyers for Civil Justice.  What they have written will well serve defendants who need to draft motions under amended Fed. R. Evid. 702 urging courts to bar unreliable expert opinions at the threshhold.  The article includes citations to virtually all Rules Committee materials that anyone would want to cite. If the words of Rule 702 and the intentions behind them matter — and they should — the Behrens/Trask article will be a valuable resource.

Sometimes when we summarize interesting law review articles we characterize what we are doing as client service; we blogsters read articles so that you do not have to.  That is not the case here.  The Behrens/Trask article is so well written, sourced, and reasoned that you will want to peruse it yourself. Here is the article’s abstract, describing what is in the article:

Federal Rule of Evidence 702 was amended effective December 1, 2023. The Rule was amended to clarify and emphasize that expert testimony may not be admitted unless the proponent demonstrates to the court by a preponderance of the evidence that the proffered testimony meets all of the Rule’s admissibility requirements. The amendment was necessitated by decisions by many federal courts incorrectly applying the reliability requirements set forth in Rule 702(b) and (d) and declaring that expert testimony is presumed to be admissible. Rule 702 was also amended to prevent “overstatement” by experts. Rule 702(d) now emphasizes that an expert’s opinion must stay within the bounds of what can be concluded from a reliable application of the expert’s basis and methodology. The Article discusses the widespread misapplication of Rule 702 since it was last amended in 2000. The Article then discusses the march toward the 2023 amendment with a detailed history of the amended Rule’s development. Next, the Article discusses the amended Rule and some early decisions showing how the Rule is to be applied. The Article also suggests some principles for litigants and courts to keep in mind as they apply Rule 702. The Article concludes by calling on judges to embrace their gatekeeping obligation and to faithfully apply the text of Rule 702 over any obsolete case law to the contrary.

The article makes clear how the 2023 amendments to Rule 702 were necessitated by judicial mangling of the 2000 amendments. The 2000 amendments (which came seven years after the Daubert decision) emphasized the court’s gatekeeping responsibility and introduced several reliability requirements. Leaning a bit too heavily on the “liberal thrust” language in Daubert, too many courts applied a presumption of expert admissibility and held that weaknesses in an expert’s reliance materials or methodology went to weight, not admissibility. Those courts ignored the Rule 104(a) requirement that a proponent of evidence must satisfy every element of Rule 702 by a preponderance of the evidence. The result was, at best, inconsistency, as some courts followed the rigors of Rule 702 and some did not, and, at worst, wholesale admission of admittedly “rather weak” or “shakey” expert rulings in mass torts such as Roundup, Bair Hugger, etc.

Courts were getting Rule 702 wrong, and were adding to that vast pile of wrong.  Instead of functioning as gatekeepers, some courts played at being matadors, waving the bull by and onto the jury.  The folklore and mythology ofDaubert became untethered from the language of Rule 702.  Courts wrongly relied on precedents antedating the 2000 amendments to Rule 702, and there is a very real danger that courts will rely on incorrect precedents antedating the 2023 amendments.  That is the “obsolete” law to which the article refers. For that reason, the article (and this blog) urge defense lawyers to stop saying Daubert and start saying Rule 702.

Interestingly, many of the opponents to the 2003 amendments demonstrated by their comments how throughly Rule 702 had been misunderstood and misapplied, and thereby also demonstrated how necessary the amendments were.  Some opponents pushed back on the preponderance standard, arguing that it incorrectly suggested that expert testimony must be supported by admissible evidence.  The drafters of the amendments finessed this non-problem by deploying the language of “more likely than not” rather than preponderance. 

The Behrens/Trask article acknowledges the key role played by an earlier law review article by Bernstein and Lasker (2015), which supplied empirical evidence that too many judges were not following Rule 702.  That article was a catalyst.  Further, one of the reporters to the Advisory Committee on Evidence Rules, Professor Capra, believed that “public reports challenging the reliability of various forms of forensic evidence” would furnish a strong reason for the Advisory Committee to revisit Rule 702.  Professor Capra seems to be no stranger to understatement, as he pointed out that “[i]t is certainly a problem when Evidence Rules are disregarded by courts.” Indeed.

Now we have the 2023 amendments in place.  The proponent of expert evidence must have “demonstrated by a preponderance of the evidence” that the expert testimony will help the trier of fact, “is based on sufficient facts or data,” “is the product of reliable principles and methods,” and that the “expert’s opinion reflects a reliable application of the principles and methods to the facts of the case.”  The drafters of the 2023 amendments must have felt like city water superintendent William Mulholland when he gave the signal to turn on the water from the newly constructed Los Angeles aqueduct:  “There it is.  Take it.”

Have courts so far taken it? What has happened to Rule 702 jurisprudence?  A very helpful part of the Behrens/Trask article takes us through cases from M.D. Pa., N.D. Cal (!), the Sixth Circuit, D. Arizona, etc. where judges took the amendments very seriously and put some oomph behind their Daubert — oops — Rule 702 analysis.  The article also cites the Sardis decision from the Fourth Circuit, which was issued before the 2023 amendments went into effect, but took the amendments and their rationales into account in reversing a multi-million dollar award based on unreliable expert testimony involving an alleged defect in the packaging of garage doors.  The Sardis decision is important, not just because it shows that gatekeepers can also tend to garage doors, but also because it shows that the impetus behind the 2023 amendments was to correct judicial errors.  

The Behrens/Trask article should also help correct — or, better still, prevent — judicial errors.  As the article shows, “Rule 702 is one of the best-documented areas where courts have frequently misapplied (or ignored) the law.”  The article adds to and clarifies that documentation.  The hope is that there is now no more excuse for any court to shirk its gatekeeping duties.

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Bespoke makes us think of tailoring, which makes us think of London’s Savile Row, which makes us think of Annie’s You’re Never Fully Dressed Without a Smile (“who cares what they’re wearing on Main Street or Savile Row”).  Which as it turns out is perfect for today’s case about a plaintiff who wanted the court to recognize a custom-tailored cause of action against the manufacturer of Invisalign teeth aligners.

Plaintiff in Adair v. Align Technology, Inc., 2024 U.S. Dist. LEXIS 233300 (W.D. Tex. Dec. 27, 2024), consulted a dentist to have her teeth realigned.  Her dentist prescribed Invisalign aligners and performed imaging to monitor her progress.  In other words, at all times plaintiff’s dentist was responsible for choosing the size of the aligners and overseeing plaintiff’s care.  Plaintiff alleges the aligners pushed her teeth too far forward and that she will need to undergo additional treatment to correct the problem.  Id. at *1. 

Plaintiff sued the manufacturer of the aligners claiming it was negligent in providing “inappropriate” aligners and in failing to read or properly read her dental images.  Id. at *2.  However, under Texas law a products liability claim sounding in negligence turns on whether the manufacturer used ordinary care in “design and production” of the product.  Id. at *4.  Texas does not impose on medical product manufacturers a duty to assure the product is being properly used by the physician.  So, plaintiffs were asking the court to “craft a new duty tailored specifically to this case.”  Id. at *5. The court refused. 

 Applying the recognized duty to the facts, the court found plaintiff failed to connect her alleged injury to either defendant’s design or production of the aligners.  The images plaintiff alleges defendant should have reviewed were taken during her treatment, long after the aligners were designed and produced, and therefore had no bearing on that process.  Id. at *5-6.   Plaintiff’s complaint was dismissed but given an opportunity to move for leave to amend. 

This is a useful case for the general proposition that prescription medical product manufacturers have no duty to supervise how doctors use their products.  And, that products liability claims belong on Main St. and not Savile Row.

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Public policy favors scientific and medical research.  So do we.  While the theories of various claims asserted against sponsors of medical research—and the reasons for rejecting them—vary greatly, the underlying incentive to promote good research certainly plays a role in protecting those that sponsor and conduct medical research from virtually unlimited liability for alleged downstream harms.  Indeed, the very concept of proximate cause that is now so embedded in tort law derives from public policy, as spelled out in Palsgraf:

A cause, but not the proximate cause. What we do mean by the word “proximate” is, that because of convenience, of public policy, of a rough sense of justice, the law arbitrarily declines to trace a series of events beyond a certain point. This is not logic. It is practical politics. Take our rule as to fires. Sparks from my burning haystack set on fire my house and my neighbor’s. I may recover from a negligent railroad. He may not. Yet the wrongful act as directly harmed the one as the other. We may regret that the line was drawn just where it was, but drawn somewhere it had to be. We said the act of the railroad was not the proximate cause of our neighbor’s fire. Cause it surely was. The words we used were simply indicative of our notions of public policy. Other courts think differently. But somewhere they reach the point where they cannot say the stream comes from any one source.

Palsgraf v Long Is. R.R. Co., 248 NY 339, 352-53 (N.Y. 1928).  Our homage to Palsgraf is not mere coincidence to the decision we discuss here, which follows logically from Palsgraf even if not proximately so.

In Heath v. EcoHealth Alliance, No. 1:23-cv-08930 (JLR), 2024 U.S. Dist. LEXIS 231002 (S.D.N.Y. Dec. 19, 2024), the court dismissed negligence and strict liability theories asserted against a non-profit that received an NIH grant and gave some of the money as a subgrant to an outside lab.  This is not a products case, as plaintiff’s decedent never took any product connected to the research from the lab.  No, the claims asserted in Heath were far more contrived.  Per plaintiff’s allegations—the case was decided on a motion to dismiss—$76,000 of defendant’s grant money went to the lab in Wuhan, China, that allegedly released the virus responsible for the COVID-19 pandemic and later the death of plaintiff’s decedent.  (The allegation of the decedent’s death was actually that he died after being diagnosed with COVID-19, which is not exactly the same.  His obituary is silent on the cause of death.)  If we had resolved to be more understanding of the motivations of plaintiffs this year, then we might empathize with the desire to hold someone responsible for personal tragedy.  Yet we do know something about proximate cause, product liability law, and tort law more broadly, so we can only go so far in terms of the choice of defendant in Heath.  The estate in Heath was not alone in its choice, however, as there were at least two failed prior cases against this same defendant asserting similar theories in New York state courts.  Heath was in federal court by reason of diversity jurisdiction because plaintiff is a Colorado resident, as was her decedent.

As far as we can tell, imposing liability on the defendant in Heath would have been unprecedented by a good measure.  The court rightly dismissed the claims and denied leave to amend.  The reasoning for the rejection does bear some review because it supports rejecting other attempts to impose liability related to research activities that might not be so far removed from the plaintiff’s injuries.  Consistent with another theoretical resolution to be more evenhanded, we do note that the court in Heath left out a few things beyond a harkening back to Palsgraf.  First, this being a case sitting in diversity and the claims being so obviously based on major extensions of New York law, we would have liked to see some nod to Erie restraint.  Given that New York trial courts had rejected the same extensions in the two cited cases against the same defendant, Erie principles virtually eliminated a prediction that the Court of Appeals of New York would create limitless liability for directing subgrant money to an alleged bad actor.  Second, while New York has a strict liability theory that is not limited to product liability, its non-products variant sounds in nuisance and has been limited to an activity carried out on defendant’s land or as part of a for-profit business that is proximal to the plaintiff’s interests.  Heath need not have taken a deep dive into other attempted expansions of nuisance theories, but it might have set some harder lines on what sort of activities could not give rise to strict liability (e.g., a non-profit passing on a portion of federal grant money through a subgrant).

Heath went beyond a mere smell test and considered whether the allegations in plaintiff’s complaint stated a claim for negligence or strict liability.  On the former, the court’s examination of duty was dispositive.  “New York courts have been cautious in extending liability to defendants for their failure to control the conduct of others.”  2024 U.S. Dist. LEXIS 231002, *6 (citation omitted).  The allegations here related to conduct by the Wuhan lab, over which defendant had no right of control and exercised no control.  “The key consideration critical to the existence of a duty in these circumstances is that the defendant’s relationship with either the tortfeasor or the plaintiff places the defendant in the best position to protect against the risk of harm; and that the specter of limitless liability is not present because the class of potential plaintiffs to whom the duty is owed is circumscribed by the relationship.”  Id. at *7 (citation and punctuation omitted).  Defendant was far from in the best position to protect against any risk related to the Wuhan lab and nobody could have reasonably expected its limited funding would give it the ability to do so.  Similarly, “The remote connection between Defendant’s allocation of funding to the [lab] and Plaintiff’s husband’s eventual death from COVID-19 would also create the risk of widespread, insurerlike liability, since the class of potential plaintiffs is so large and undefined.”  Id. at *10 (citation omitted).  Thus, the defendant owed no duty to plaintiff’s decedent in connection with its subgrant.

As noted above, New York has a strict liability theory based on “an ultrahazardous or abnormally dangerous activity,” not just in connection with the manufacture or sale of a product, which defendant clearly did not do.  Even if this theory could ever be applied to a non-profit that was not directly affecting its neighbors with an activity on its property, an expansion to liability for the “funding of biomedical research” would be quite a reach.  In this case, the plaintiff did not allege that defendant did relevant research itself or that its money to the lab was earmarked for the research that plaintiff claims led to the release of the virus responsible for the pandemic.  Id. at *16.  Nothing about funding research here was linked to any of the factors recognized for ultrahazardous activities, including that it created a high risk of harm or that funding research is uncommon or inherently inappropriate.  So, the complaint did not come close to stating a claim for strict liability as recognized by New York law.  This makes sense if you consider that the non-product liability strict liability was intended, in the language of the seminal New York case, for an “unpreventable miscarriage of the activity for harm resulting thereto from that which makes the activity ultrahazardous, although the utmost care is exercised to prevent the harm.”  Plaintiff’s core claim was that the pandemic was preventable—although not by defendant—and that something far less than utmost care was exercised by the Wuhan lab.  To impose liability on a mere partial funder of research that can be connected by some stream of non-proximate causation to an injury would certainly be a miscarriage of justice.  To do so would have a terrible chilling effect on research.  We are glad that Heath did its part to keep the chill away.

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As 2024 has come to an end, our loyal readers have joined us in reviewing our ten worst decisions of the past year and our ten (plus runners up) best decisions of the past year.

As we do each year, we’re pleased to announce that four of your bloggers – Bexis, Steven Boranian, Stephen McConnell, and Lisa Baird – will be presenting a free 90-minute CLE webinar on “The Good, the Bad and the Ugly: The best and worst drug/medical device decisions of 2024” on Thursday, January 16th at 12 p.m. EST to provide further insight and analysis on these cases.

This program is presumptively approved for 1.5 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.

Additionally, please note that CLE credit for on-demand viewing is only available in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Credit availability expires two years from the date of the live program. In order to receive CLE credit, you will need to notify Learning & Development CLE Attendance once you have viewed the program on-demand. 

The program is free and open to anyone interested in tuning in, but you have to sign up in advance here.

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For our friends practicing in the Sunshine State, we want to highlight new rules amendments which took effect on January 1, 2025.  Most notably, Florida joins states around the country adopting the proportionality language from Federal Rule of Civil Procedure 26(b)(1).  See Fla. R. Civ. P. 1.280(c).

Continue Reading New Proportionality Language for Florida Rules
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Happy New Year. We are doing that usual January/Janus thing of looking both backwards and forwards. We are gearing up for a massive litigation in 2025, for a couple of trials, and for the January 16 Drug and Device Law webinar on the best and worst cases of 2024. And we’re still finding some 2024 cases that offer interesting doctrinal baubles.

A couple of years ago we attended a bench/bar conference sponsored and run by plaintiff lawyers.  (Whoops – as happens more and more, we belatedly realize that “couple of” should be “more than 10.”  Yikes.) We were among the two or three defense hacks invited for target practice and comedy.  At lunch, one of our favorite plaintiff lawyers, a brilliant and brutal fellow, told us that we’d be missing a bet if we didn’t get into gadolinium litigation.  He said that the science issues were fascinating and, best of all (at least from his predatory perspective), the injuries were ghastly. Prolonged exposure to the gadolinium contrast dye could produce a condition in which organs hardened.  The plaintiff lawyer said that some clients became “living statues” who invariably died painful, prolonged deaths. And then the judge overseeing the federal MDL issued one of the worst, pro-plaintiff Daubert rulings we’ve ever seen.  Bexis called it “spherical error.”

Thus, Langara v. Bayer  Corp.,, 2024 WL 5186723 (D. Conn. Dec. 20, 2024), is a gadolinium contrast dye claim that arrives as a blast from the past.  The court dismissed the case on grounds of both statute of limitations and preemption.  This double-barreled ruling makes the appellate prospect dismal for the plaintiffs. The court also denied leave to amend because of futility. Yogi Berra said “It ain’t over till it’s over.”  Well, the Langara case is over. To quote amusement park ride operators, Langara has come to a “complete and final stop.” That termination comes even though the Langara court bent over backwards to cut the pro se plaintiffs some slack.   

The medical procedure took place back in 2007.  The plaintiffs began their litigation journey by filing suit against the defendants in Massachusetts state court in 2020.  The case was removed to federal court.  The D. Mass. judge dismissed the case for lack of personal jurisdiction.  The plaintiffs appealed but the First Circuit affirmed.  In 2024, the plaintiffs filed a case in Connecticut state court.  The defendants removed to federal court (D. Conn.).  Then the defendants moved to dismiss the entire complaint, which included claims for negligent failure to warn, negligent pharmacovigilance, negligent marketing and design, breach of express warranty, fraudulent, negligent, or innocent misrepresentation, fraudulent concealment and omission, and for the husband, loss of consortium.  If some of those causes of action sound meritless to you just on their face, join the club. It turns out that, facial frailness aside, all the causes of action are precluded by the statute of limitations and federal preemption.

On this blog, we do not typically linger on statute of limitations issues.  Such issues are fact-specific and one can learn only so much from any particular court decision. Here, the plaintiff suffered injuries immediately after receiving the gadolinium contrast dye in 2008, was told that the contrast dye caused her injuries, and then sought treatment for those injuries multiple times in 2008 and 2009.  The Connecticut statute of limitations for product liability claims is three years, so the 2024 complaint is terribly late. But the plaintiff argued that her claims did not accrue until 2017, when her “doctors told her that the sickness, harm and injury from which she has been suffering for years since her MRI in December 2008 was directly related to  her exposure” to the contrast dye. 

But 2017 is still more than three years before 2024, right?  Hold on.  We’ll get there.

In the meantime, the Langara court agreed that the action accrued no later than 2009.  Still, you can see how this factual inquiry could get messy, right?  

Now we are at the most interesting portion of the statute of limitations analysis in Langara, which revolves around the application of the Connecticut saving/tolling statute. That savings provision allows a plaintiff to re-file a dismissed action within one year of dismissal so long as the action was originally commenced within the statute of limitations, and the dismissal was based on one of the specific procedural reasons enumerated in the statute. Under the plaintiff’s reasoning, the action did not accrue until 2017, she beat the statute of limitations by filing the Massachusetts case within three years, and then she filed in Connecticut within one year of the Massachusetts dismissal.  The Connecticut savings clause really would save her case.  Right?  Wrong.

 Lots of states have such savings provisions, but the Connecticut statute did these plaintiffs no good.  The plaintiffs had played forum shopping games with their prior action, bringing it in a state where they did not live.  Too bad.  The Connecticut statute applies only to non-merits dismissal of actions originally filed in Connecticut state or federal court. The earlier Massachusetts case (whether state or federal) was not covered by the savings clause.  (In 1636, the same year that saw the founding of a certain preeminent college in Massachusetts, a group of approximately 100 people left Massachusetts and founded a settlement at Hartford. Ever since then, Massachusetts and Connecticut have been separate.  Sure, some residents of the Nutmeg State (far and away the best state nickname – charming and without the vast pretension of the “Empire,” “Keystone,” “Golden” or “Sunshine” states) call themselves part of Red Sox Nation, but nobody is fooled. Anyway, the Langara court was not fooled, and it held that the plaintiff’s claims were time-barred.   

But it is the alternative preemption holding that supplies the main reason why the Langara case is blogworthy.  The court did not need to reach the issue, but these serial plaintiffs probably needed to hear that their case had no chance. Preemption was the primary reason gadolinium contrast litigation never really took off when plaintiffs tried to make a mass tort out of it in the 2019-2020 time period.  For the design and manufacturing claims, a manufacturer would need prior approval from the Food and Drug Administration (FDA)  for any “major”: changes to the design and manufacturing of already-approved drug products. So those claims are clearly preempted. For the labeling claims, the issue was whether the defendant could have unilaterally added a warning that gadolinium retention could harm patients like the plaintiff who did not have pre-existing renal problems. But at the time of the plaintiff’s procedure, the FDA found that gadolinium did not cause any harm except in patients with pre-existing renal problems.  Because the FDA already determined that the defendant’s product did not cause any serious conditions to people like the plaintiff, the plaintiff could not use the changes being effected (CBE) regulation as a source of power to make a unilateral label change to say something the FDA had already found to the contrary.  The plaintiffs came up with no “new evidence” during the relevant time period that indicated “risks of a different type or greater severity.” Moreover, the FDA’s determination that gadolinium affected only people with pre-existing renal disease constituted “clear evidence” that the FDA would have rejected the plaintiffs’ contrary contention.  In conclusion: “As a result, even accepting as true the allegations in Plaintiff’s Complaint, Defendants could not amend  [the gadolinium product] label through a CBE regulation, nor would the FDA have approved such a change if they had attempted to do so.”

The Langara complaint was not just late; it was a loser.

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This one seems pretty straightforward to us, but that did not stop plaintiff in Argueta v. Walgreens Company, 2024 WL 5186825 (E.D. Cal. Dec. 20, 2024), from trying to make a claim based on allegations that the product was illegal to sell because it was not FDA approved.  No allegation that the product caused any physical harm.  No allegation that the product did not work as intended or was ineffective.  The court hardly needed to dig deep to reach the conclusion that plaintiff was bringing a prohibited private cause of action to enforce the Food, Drug, and Cosmetic Act (“FDCA”). What could be more FDCA-enforcement than a decision on whether a product is approved or not? 

The product is an over-the-counter drug, phenazopyridine hydrochloride (“PhenAzo”), used to treat symptoms of urinary tract infections.  Id. at *1.  Plaintiff’s claims, brought on behalf of herself and a putative class, for breach of express and implied warranty and unfair competition were all premised on allegations that the product was not FDA-approved and therefore it was not lawfully on the market.  Id. at *1-2.  Allegations that it turns out are not factually supported.

Defendant asked the court to take judicial notice of a National Institutes of Health (“NIH”) website, which the court concluded it could because the website is a matter of public record “that can be accurately and readily determined from sources whose accuracy cannot be reasonably questioned.”  Id. at *4.  According to the NIH, the drug at issue was first synthesized in 1914 and was approved for sale in 1928 – ten years before the FDCA was enacted.  Id. at *4.  Meaning that PhenAzo is a grandfathered drug that need not undergo the FDCA approval process and that the FDA itself has not challenged.  Therefore, separate and apart from preemption, the court took judicial notice that PhenAzo is in fact approved for the treatment of UTI symptoms.  It is not a question of fact, but rather a statement of fact.  Id. at *8.

But the heart of the opinion turns on preemption and the court had ample Ninth Circuit precedent on which to rely:

Plaintiff’s entire complaint is premised upon the lawfulness of Defendant’s sale of the Products under the FDCA, whether they are FDA-approved or are marketed under an established OTC drug monograph. This squarely triggers implied preemption under the FDCA as articulated in Perez and Nexus Pharmaceuticals.

It did not matter that plaintiff’s claims were not premised on a specific FDCA violation.  Id. at *7.  Plaintiff claims the defendant violated the FDCA by selling PhenAzo without proper FDA approval.  Therefore, plaintiff’s claims rise or fall on whether there was an FDCA violation making them prohibited private FDCA-enforcement actions and impliedly preempted.   

Plaintiff made a half-hearted request for leave to amend but did not support her argument with any indication of how she could cure her complaint.  Leave to amend was denied as no matter how plaintiff dressed up her claims, they would be “veiled allegations of an FDCA violation.”  Id. at *6.

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