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Little more than a year ago, in our “Texas Mess” post, we critiqued what we called a “bizarre complaint” recently filed by the Texas attorney general (“TAG”) against a major COVID-19 vaccine manufacturer.  We described that complaint as a mélange of “various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media.”  On the merits, we predicted that the whole kit and kaboodle would be precluded by the PREP Act because:  (1) that statute “contains one of the most thoroughgoing express preemption clauses known to the law,” and (2) “pandemic countermeasures – specifically vaccines – are at the heart of” the act’s protections.”

And that’s precisely what happened at the end of 2024.  The entire complaint was dismissed for failure to state a claim due to PREP Act preemption.  “More specifically, the Court finds that as a matter of law under the circumstances of this case, the Defendant is entitled to immunity under the Public Readiness and Emergency Act (‘PREP Act’).”  State of Texas v. Pfizer, Inc., C.A. No. 5:23-CV-3l2-C, slip op. at 1 (N.D. Tex. Dec. 30, 2024).  Further, “both the PREP Act and the Food, Drug, and Cosmetic Act (“FDCA”) preempt Plaintiffs claims.”  Id. at 1-2.  Finally, adding insult to injury, the decision held that the TAG failed to apply the state’s consumer protection statute correctly.  Id. at 2 (“the alleged statements by Defendant were not connected to any ‘trade or commerce’ or any ‘consumer transaction’”).  Therefore, the complaint (called a “petition” in Texas parlance) was “DISMISSED for essentially the reasons argued in the Motion and Reply.”  Id. (online links added).

That’s it.  In only two pages, the entire TAG conspiratorial fantasy bit the dust.

The opinion was sufficiently terse that both Lexis and Westlaw missed it – and we didn’t find out about it for nearly a month.

To learn more about the why, how and wherefore of this dismissal, we followed the decision’s reference and took a look at the defendant’s brief and reply brief in support of the motion to dismiss.

The principal brief bluntly state that TAG “has no legal right to insert itself between FDA and the American people.”  Brief at 2.  Why?

 Congress has tasked FDA, not state officials, with deciding whether [defendant’s] vaccine is sufficiently safe and effective, and federal law presents several insurmountable barriers to this lawsuit. Not only does [defendant] have statutory immunity under the PREP Act, but TAG’s claims are preempted twice over.

Id.

Addressing the PREP Act, the principal defense brief pointed out that even TAG “acknowledged [that], federal law provides [defendant] with broad immunity from claims related to the COVID-19 vaccine” – first and foremost the PREP Act.  Id. at 10.  The first Trump Administration “identified COVID-19 vaccine manufactures as ‘covered persons’ and their vaccines as ‘covered countermeasures’” under the statute.  Id.  TAG’s allegations also involved a PREP Act “claim for loss,” since the act “defines ‘loss’ broadly, stating ‘the term ‘loss’ means any type of loss.’”  Id. at 11.

Under this expansive definition, the statute provides immunity from claims for “any type of loss” related to the administration or use of [defendant’s] vaccine.  The claims here fall squarely within this broad definition of “loss.” According to [TAG]’s own complaint, [defendant’s] alleged “unlawful acts or practices” “caused injury, loss, and damage to [the State], as well as caused adverse effects to the lawful conduct of trade and commerce, thereby directly or indirectly affecting the people of this State.”  The complaint further requests damages and restitution, which are only recoverable when the State or its citizens have suffered a “loss.”

Id. (citations omitted).  Adding up covered persons and countermeasures, as well as covered losses, the brief concluded, as to the PREP Act immunity:

The complaint in this case asserts state-law claims for “losses” “caused by, arising out of, relating to, or resulting from the administration to and use by” individuals of [defendant’s] vaccine, a covered countermeasure.  Accordingly, the PREP Act immunizes [defendant] against this lawsuit.

Id. at 12.

Moving from immunity to preemption, the defense principal brief next argued:

Congress enacted the PREP Act to incentivize private companies to assist the federal government in providing potentially lifesaving countermeasures during a public health emergency without fear of later being sued for actions taken in a time of crisis.  In offering immunity to the manufacturers of COVID-19 vaccines, HHS emphasized the serious public health emergency caused by the pandemic and the need for “a sustained, coordinated proactive response by the [g]overnment in order to contain and mitigate the spread” of the virus.  [Defendant] answered the federal government’s call.  Despite this, [TAG] seeks to hold the company liable under state law for actions “relating to,” among other things, the “design,” “development,” “clinical testing,” and “safety and efficacy” of the COVID-19 vaccine.  This lawsuit, which is in direct conflict with important federal prerogatives, is tailor made for dismissal under the PREP Act.

Brief at 14 (citations omitted).

The defense brief goes on to argue, persuasively, that the TAG complaint is also preempted directly by the FDCA.  Id. at 14-18.  But since the court’s decision rests on the PREP Act without mentioning the FDCA, we’ll skip this aspect of the defense preemption argument.

Moving to Texas Deceptive Trade Practices Act (“DTPA”), the defense principal brief points out a rather basic flaw in TAG’s allegations – the state had nothing to do with the transactions at issue.

[T]he federal government was the sole U.S. purchaser of the vaccine during 2020 and 2021 − when [defendant] allegedly overstated the vaccine’s benefits − and until very recently the federal government made the vaccine available, free of charge, to all people living in the United States.

Id. at 19 (citation omitted).  Thus, the allegations did not concern any “trade or commerce” subject to state regulation.  The feds bought the vaccine, and gave it away free to the public.  On one end, Texas can’t regulate the federal government, and on the other, the DTPA is “concerned with ‘business,’ not gratuitous transactions.”  Id. at 20 (citation omitted).  “Trade,” as used in a deceptive practices statute, “means ‘[t]he business of buying and selling or bartering goods or services.’”  Id. at 21 (citation omitted).

[R]ead as an integrated whole, . . . the DTPA applies to private business transactions, not charitable endeavors or large-scale government programs to advance the public health. . . .  [Defendant] Pfizer did not make [any] statements in connection with the sale of the vaccine.  As previously discussed, the statements in question, which Pfizer allegedly made in 2020 . . ., took place long after [defendant] contracted to provide hundreds of millions of doses to the federal government; the vaccine was not for sale to individual Texans.  Because [defendant’s] so-called “misrepresentations” in this case were disseminated to the general public − which received the vaccine for free − and not the federal officials who actually authorized and purchased the product, the alleged misstatements did not occur “in the conduct of any trade or commerce” and the complaint fails to state a DTPA claim.

Id. at 22 (citations omitted).

The defense reply brief, also mentioned in the opinion, mostly reiterated these same points.  TAG, the defendant argued, “argues for a narrower reading,” but only by “cherry pick[ing] words from the statute while ignoring the complete statutory language.”  That flaw “permeated” TAG’s papers, “which misleadingly cite[d] not just the language of the PREP Act, but also the DTPA and the relevant case law.”  Reply br. at 2-3.  TAG “violate[d bedrock] canons of construction at every turn.”  Id. at 3.  First, the PREP Act’s protections are hardly limited to “personal injury.”

Under the PREP Act, “the term ‘loss’ means any type of loss.”  This broad language is not limited to personal injuries.  In fact, the statute provides “any type of loss” also includes, but is not necessarily limited to, “loss of or damage to property, including business interruption loss.” Read as an integrated whole, the PREP Act’s immunity provision extends far beyond “physical or mental loss.”

Id. at 4 (citations omitted).

Next, TAG argued that the DTPA did not require the state to prove a loss – but that ignored TAG’s own complaint, which repeatedly alleged various losses.  Id.  The PREP Act further “prohibits claims far beyond those stemming ‘from the administration of’ a covered countermeasure.”  Id.  The PREP Act’s “broad grant of immunity” reached any allegations that “arise out of” or “relate to” administration of the COVID-19 vaccine, and the “very first page” of TAG’s complaint alleged that the purported “misleading” claims caused “hundreds of millions of Americans” to receive the defendant’s vaccine.  Id. at 5 (citations and quotation marks omitted).  The reply pointed out that “Courts have rejected as ‘nonsensical’ the argument that consumer protection claims lack a sufficient nexus to the ‘administration’ of a covered countermeasure.”  Id. (citation omitted).

Further, while states had no power to enforce vaccine-related claims, the PREP Act included an “explicit carve-out for federal enforcement actions.”  Id. at 6 (citation omitted).  TAG’s “absurd” argument that a manufacturer “could claim with impunity that the vaccine cures cancer, entirely misse[d] the point.”  Id.  Cancer was not a within the “the category or categories of diseases” within the government’s PREP Act declarations.  Id. (citations and quotation marks omitted).

TAG’s arguments against PREP Act preemption were equally unavailing:

[TAG]’s claims are in direct conflict with [the statute].  The complaint’s entire premise is that [defendant’s] statements about the vaccine misled individuals, thus “harm[ing] Texas and its citizens.”  Even [TAG] agrees that such claims, if brought by individuals, would be barred. . . .  [TAG] asserts, however, that the state may bring the same claim “on behalf of the public interest of its citizens” acting as “parens patriae.”  This cannot be correct; the preemption clause would be meaningless if states could bring the very claims the statute bars individuals from bringing.  At a minimum, [TAG]’s interpretation would read the word “enforce” out of the preemption clause entirely.  That is something courts must never do.

Id. at 7 (citations omitted).  Nor did the inane “mirror” federal requirements argument matter.  The PREP Act, as opposed to the FDCA, cannot be misread in this fashion, because the PREP Act does not rely on the FDCA at all.  Id.

Nor, as the defense reply pointed out repeatedly, did TAG offer any precedent supporting its position that federal distribution of free vaccines somehow came within the purview of the DTPA.  Id. at 8-10.  Other than nitpicking the precedent cited in the defendant’s brief, TAG “d[id] not meaningfully address the DTPA’s statutory text.”  Id. at 9.  Sure, the state did not itself have to be a “consumer,” but it had to be suing over “consumer” transactions, which free federal distribution was not.  Id.  “[T]he Texas Legislature was concerned with ‘business,’ not gratuitous transactions.”  Id. at 10 (citation and quotation marks omitted).

We understand that TAG is taking an appeal.  We don’t think that even the Fifth Circuit will find that appeal very appealing.

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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 – recently presented a free 90-minute CLE webinar on “The Good, the Bad and the Ugly: The best and worst drug/medical device decisions of 2024.” For those unable to attend live, and who would like the free CLE, a recording of the Webinar is now available online to view on-demand.

To view the webinar on-demand, please click here to register for, and then watch, the recording.

The webinar provides further insight and analysis on the cases featured in our annual posts on the worst decisions and best prescription drug and medical device decisions of the past year.

CLE Information for On-Demand Viewers: In order to receive CLE credit, you will need to notify Learning & Development CLE Attendance once you have viewed the program on-demand.

**Please note – 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.

CLE Questions? Contact Learning & Development CLE Attendance.

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When a defendant removes a case to federal court on the basis that the case presents federal questions, what happens if the plaintiff amends the complaint to remove all references to federal law, leaving only state-law claims?  The U.S. Supreme Court has ruled that once the plaintiff amends to delete all federal claims, a federal district court has no discretion to exercise jurisdiction over the remain state claims.  Remand is required. 

The case is Royal Canin U.S.A., Inc. v. Wullschleger, No. 23-677, 2025 WL 96212 (U.S. Jan. 15, 2025), a matter that we flagged as flying under the radar just a few months ago.  The opinion is now in, and the Supreme Court has squarely and unanimously established plaintiffs as “masters” of their complaints, including their chosen venue.  The Court has also upended the expectations of generations of lawyers brought up with the rule that federal jurisdiction is determined at the “time of filing.” 

The plaintiff in Royal Canin filed her complaint in Missouri state court and alleged violations of Missouri statutes and also violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”).  So the defendant removed the case to federal court.  The plaintiff, however, didn’t like that, so she amended her complaint to “delete its every mention of the FDCA” and moved to remand the case back to state court.  Id. at *4.  Having freely alleged violations of federal law—with the predictable consequence that the defendant would remove the case to federal court—can a plaintiff just call a “do over” and escape federal court merely by redlining federal law out of her complaint? 

The answer is yes, and it comes down to the limits of supplemental jurisdiction under 28 U.S.C. § 1367.  When a federal court has original jurisdiction over a case (for example, under federal question jurisdiction), section 1367 confers authority on the court to decide other claims involving only state law, so long as the state claims are “so related to” the federal claims as to form “part of the same case.”  This is supplemental jurisdiction, and it typically involves federal claims and state claims that arise from the same operative facts.  Royal Canin, at *5. 

Because supplemental jurisdiction begins with the federal court having original jurisdiction in the first place, the Supreme Court ruled that supplemental jurisdiction cannot survive once original jurisdiction goes away.  Or, as the Supreme Court bluntly stated, “Once the plaintiff has ditched all claims involving federal questions, the leftover state claims are supplemental to nothing—and § 1367(a) does not authorize a federal court to resolve them.”  Id. at *6.

The most important point for the Court—cited repeatedly in the opinion—was that section 1367 does not distinguish between cases removed to federal court and cases originally filed there.  That is critical because the Court has already held that when a plaintiff files a complaint in federal court and then voluntarily amends the complaint, courts look to the amended complaint to determine federal jurisdiction.  And, if an amended complaint in an originally filed case withdraws the federal claims, that filing divests the federal court of jurisdiction.  Id. (citing Rockwell Int’l Corp. v. United States, 549 U.S. 457, 473–474 (2007)). 

The Supreme Court held that the same rule should apply to cases removed from state court, noting that if Congress had intended to grant district courts discretion to decline jurisdiction under these circumstances, it would have said so.  The Court further reasoned that this result is consistent with how Congress typically views how amended pleadings can impact federal jurisdiction.  An amended complaint can create federal jurisdiction where there was none before, and section 1367 itself contemplates that when a plaintiff files an amended complaint, jurisdiction is “reviewed anew.”  If federal claims are removed, then “the state-law claims are just state-law claims, outside §1367(a)’s purview.”  Id. at *7.

Again, the court circled back to the theme that it should make no difference whether a case was removed to federal court or filed in federal court to start.  Here is the quote that you will probably most often see:

The appropriateness of federal jurisdiction—of the lack thereof—does not depend on whether the plaintiff first filed suit in federal or state court.  Rather, it depends, in either event, on the substance of the suit—the legal basis of the claims (federal or state?) and the citizenship of the parties (diverse or not?).  (That focus on substance is indeed why original jurisdiction and removal jurisdiction generally mirror each other in scope.) 

Id. at * 9.  In so holding, the Court dismissed some legitimate points.  First, what about the rule that federal jurisdiction is determined at the “time of filing”?  Well, that rule concerns only the actual “state of things” relevant to jurisdiction.  The facts on the ground.  A New York plaintiff who sues a California defendant cannot destroy diversity by moving to California.  By contrast, the claims and the parties can change, and when they do, they can impact jurisdiction.  Id. at *7 n.5.

Second, the Court distinguished its own prior authorities supporting the removing defendant’s position.  Most notably, the Court had itself articulated the rule that the defendant urged in a footnote in the Rockwell opinion: “[W]hen a defendant removes a case to federal court based on the presence of a federal claim, . . . an amendment eliminating the original basis for federal jurisdiction generally does not defeat jurisdiction.”  Id. at *10.  That sounds pretty on-point to us, especially coming from the Supreme Court itself.  The Court, however, called it “barely reasoned” dicta because Rockwell was an original federal case, not a removed one.  It was thus “beside the point.”  Id.  (As an aside, in declining to follow its own precedent, the Supreme Court noted that district courts and the Court of Appeal do not have the same prerogative: “It is of course a much different thing for this Court to reach that conclusion than for a lower court to do so.”  Id. at *10 n.10). 

Third, the Court did not share any concern over forum manipulation.  Plaintiffs can usually forum shop without resort to any amendments, including by dismissing their cases entirely and refiling somewhere else (provided there is no time bar).  In any event, the supplemental jurisdiction statute is what it is:  Jurisdiction follows the amended pleading, and section 1367 “offers no basis for treating original and removed cases differently.”  Id. at *10 n.9. 

In the end, because the plaintiff “reconfigured” her lawsuit to make it only about state law, it became a matter for a state court.  Remanded. 

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In this, the Year of Our Lord 2025, that title could apply to so, so, so many things.  Soooooo many things.

But this is the Drug and Device Law Blog, product liability is our niche, and what we are referring to is the new, 2024 European Union Product Liability Directive (the “PLD”), also known as Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (Nov. 18, 2024).

We have spoken and written about the issue before.  And now we are starting to jump up and down to get attention on this.

Why the cause for alarm?  Look at the litigation funding industry.  Rumor has it that they are so excited about the new PLD, they already have set up camp in Amsterdam and London in anticipation of the disputes to come.

You may be thinking to yourself, I’ve defended mass torts in some of the most plaintiff-friendly jurisdictions in the U.S., how bad can it be?

How about not actually requiring proof of defect, particularly because the product at issue is a life-saving medical device:

Some products, such as life-sustaining medical devices, entail an especially high risk of causing damage to people and therefore give rise to particularly high safety expectations. In order to take such expectations into account, it should be possible for a court to find that a product is defective without establishing its actual defectiveness, where it belongs to the same production series as a product already proven to be defective.

PLD, at 19 (emphasis added). 

How about holding subsequent remedial measures against manufacturers?  The silver lining (?) is that subsequent remedial measure “should not in itself lead to the conclusion that a product is defective.”  PLD, at 22, id. at 60. 

How about a rebuttable presumption of defectiveness where a defendant has failed to comply with an “obligation to disclose information.”  PLD, at 31, id. at 67 (“relevant evidence”). 

How about a rebuttable presumption of defectiveness “in a case of obvious malfunction… since it is unnecessarily burdensome to require a claimant to prove defectiveness when the circumstances are such that its existence is undisputed”  PLD, at 31, id.at 67.  Obvious to whom?  Undisputed by whom?   

How about a rebuttable presumption of causation “[w]here it has been established that a product is defective” (maybe through one of the defectiveness presumptions above) “and the kind of damage that occurred is, based primarily on similar cases, typically caused by the defectiveness in question” because “the claimant should not be required to prove the causal link and its existence should be presumed.”  PLD, at 32, 68.  Should we call this the “you win one, you win them all rule” for plaintiffs?

Perhaps worst of all is the rebuttable presumption of both defectiveness and causation, which will arises just because the issues are hard:

National courts should presume the defectiveness of a product or the causal link between the damage and the defectiveness, or both, where, notwithstanding the defendant’s disclosure of information, it would be excessively difficult for the claimant, in particular due to the technical or scientific complexity of the case, to prove the defectiveness or the causal link, or both…. While a claimant should provide arguments to demonstrate excessive difficulties, proof of such difficulties should not be required.

PLD, at 33 (emphasis added); see also PLD, at 68. 

And again, our clients’ essential products are called out as deserving of punishment through this evidentiary shortcut designed to lead straight to a liability finding:

Technical or scientific complexity should be determined by national courts on a case-by-case basis, taking into account various factors. Those factors should include the complex nature of the product, such as an innovative medical device.

PLD, at 33 (emphasis added). 

Also mind-boggling are the rationales given for the new PLD.  For example:

Liability without fault on the part of economic operators remains the sole means of adequately addressing the problem of fair apportionment of risk inherent in modern technological production. 

PLD, at 2 (emphasis added).  Really?  How about the regulatory systems in place in the E.U. already?  They work quite well for the pharmaceutical and medical device sectors.  How about national health care programs that provide medical care to all without risk of personal bankruptcy or the inefficiency of litigation, and the already-existing possibility of recovery from pharmaceutical manufacturers, when necessary and if appropriate, by those national health care programs?

One very modest (very modest) beneficial (or at least not openly harmful) provision that we see in the new PLD is a sort-of regulatory compliance defense: 

An economic operator . . .  shall not be liable for damage caused by a defective product if that economic operator proves . . . that the defectiveness that caused the damage is due to compliance of the product with legal requirements.

PLD, at 69. 

Another is the “state of the art” defense:

An economic operator . . .  shall not be liable for damage caused by a defective product if that economic operator proves . . . the objective state of scientific and technical knowledge at the time the product was placed on the market or put into service or during the period in which the product was within the manufacturer’s control was not such that the defectiveness could be discovered.

PLD, at 70.  But don’t get too excited:  individual E.U. nations can opt out of this one.  PLD, at 79-80. 

There is a lot more about the new PLD that warrants discussion. 

For example, it isn’t only pharmaceutical and medical device manufacturers who are in the cross-hairs.  If there is a nuclear accident, or you make free and open-source software, you are in the clear.  PLD, at 4, 47.  But other software, AI, digital manufacturing files (as for 3D printers), electricity, and raw materials are products falling within the PLD.  See PLD, at 8, 49-50.  And the new PLD applies to goods and related services.  See PLD, at 11.    

The new PLD was published in the Official Journal of the European Union on November 18, 2024.
EU Member States now have two years to “transpose” it into their national laws, i.e. by December 9, 2026, and the new PLD will apply to products put on the market in the EU after December 9, 2026.

In the coming months, we will continue to pick apart the new PLD—and continue to sound the alarm.

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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.  In talking with another great materials scientist, Ming Tang, we learned that the simple act of changing the orientation of how an object is 3D printed may change its properties in pretty significant ways.  Ming and his colleague Larry Eiselstein were even kind enough to send us an article, 3D-Printed Metallic Medical Devices: Increasing Interest from Medical Device Manufacturers, Opportunities, and Challenges, in which they explained this and other materials science issues related to 3D printing in the medical device space.  Even to a lay person, it is a quick and understandable read, not to mention eye-opening and interesting.

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!

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In the wake of last week’s webinar that we DDL bloggers presented on the best and worst cases of 2024, we received many kind notes from clients and colleagues.   The webinar was apparently a painless and – dare we say it? – even fun way to earn 1.5 CLE credits.  But we also heard from some in-house lawyers that they do not all subsist on a diet of straight product liability. Company legal departments harbor lawyers who work on a variety of matters, including intellectual property, commercial disputes, and sundry other areas.  Their point was that drug and device in-house attorneys also like to hear about those other legal issues. 

We take their point.  Accordingly, today we will discuss Nexus Pharmaceuticals, LLC v. Long Grove Pharmaceuticals, LLC, 2025 U.S. Dist. LEXIS 6058, 2025 WL 81877 (D. Mass. Jan. 13, 2025), a lawsuit brought under the Lanham Act, 15 U.S.C. section 1125(a).  The claim was false advertising. There was no personal injury alleged in the case. Instead, the alleged injury was to sales.  It was a dispute between two pharmaceutical companies. (Truth be told, we are tempted to remain mute when we see such a dispute. We do not want to stumble into client conflicts or hostilities. But this case implicates interesting issues such as a misbegotten effort at private FDCA enforcement, so here we go.) The parties were competitors.  Both sold a drug product used to enable diagnostic imaging. Go to the opinion (which is quite short) if you want to learn the details, but the key chronology in the case goes like this:


April 2023 – the FDA identified a shortage of the drug product.


June 2023 – the defendant bought the NDA for the product and any remaining stock from a bankrupt company. Because of the drug shortage, the FDA permitted the defendant to sell the old stock. In accordance with an FDA guidance, the defendant sent out a Dear Healthcare Provider letter that it would distribute the drug product to “address this critical drug shortage.”  That same language showed up on the defendant’s website. 


September 2023 – the plaintiff obtained FDA approval to market a generic version of the drug product. 


December 2023 – the FDA declared that the shortage was “resolved.”


But – and here’s the rub – even after the FDA’s declaration that the shortage was resolved, the defendant continued to distribute the drug product and continued to state on its website that the shortage still existed. The plaintiff asked the defendant to stop selling the product because the shortage had ended. The defendant refused, maintaining “that it had permission from the FDA, pursuant to its drug shortage authority, to continue selling” the product.  


Then the plaintiff filed this lawsuit, alleging that the defendant’s continuing statements about the drug shortage misled customers into believing that the plaintiff’s product was not available and that only the defendant could provide the product.  As a result, so the complaint alleges, the plaintiff lost customers to the defendant. The complaint also stated that the defendant was able to undercut on price because it was selling product from a bankrupt company that had stored the product in conditions unknown to the plaintiff or the public. 


The lawsuit was based on the Lanham Act and alleged unfair competition and false advertising. It sought a declaratory judgment against the defendant, plus actual damages. The complaint referenced one actual customer who had switched to the defendant’s product. 


The defendant moved to dismiss the complaint on several grounds, including that the plaintiff was essentially challenging the defendant’s compliance with FDA regulations, and that “the Lanham Act cannot supply a basis for relief from a statement that FDA expressly mandated a manufacturer to make.”  Those are interesting assertions and there’s a whiff of preemption, though displacement of one federal legal or regulatory regime by another does not really constitute preemption.  


But the Nexus court dodged these interesting assertions by deciding the much simpler issue of whether the claim was sound under the Lanham Act.  It was not, because 

the Lanham Act requires that the alleged misrepresentation be about the products at issue.  To prove a Lanham Act claim for unfair competition and false advertising, the plaintiff must demonstrate that:

1. The defendant made a false or misleading description of fact in a commercial advertisement about his own or another’s product;

2. The misrepresentation was material in that it likely influenced a purchase decision;

3. The misrepresentation actually received had the tendency to deceive;

4. The defendant placed the deceptive statement into interstate commerce; and

5. The plaintiff was likely injured by either a direct diversion of sales or loss of goodwill. 

Here, the plaintiff’s Lanham Act claim stumbled at the first hurdle.  The allegedly false claim that there was a shortage did “not refer to any inherent quality or characteristic” of either the plaintiff’s or defendant’s product.  Statements relating to the marketing method of a product are not related to product qualities or characteristics. (The Nexus court cited several other district court opinions that came out with similar holdings). The plaintiff did not allege that the defendant had made a false/misleading statement about the actual age of the product or its quality. It appears that such an allegation might have saved the Lanham Act claim, but we’ve already wandered far afield of our core knowledge, so we’ll leave that speculation to our readers who are smarter than we are either generally or merely with respect to the Lanham Act. 

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Today’s case — In re Tepezza Mkt’g, Sales Pracs., & Prod. Liab. Litig., MDL No. 3079, 2025 WL 81338 (N.D. Ill. Nov. Jan. 10, 2025) – doesn’t really break new ground on the substantive law, in fact it is a split decision.  But it comes from an unusual procedural posture worth pointing out. 

The Tepezza MDL was created in June 2023 and shortly thereafter the court ruled on a pending motion to dismiss in a single case.  The court denied the motion as to plaintiff’s pre-market design defect claims.  We were not particularly fond of the ruling and said so here.  It appears that since that time, the court decided to create a group of “bellwether discovery” cases.  The idea is that motions to dismiss get teed up and ruled on in the 12 “bellwether discovery” cases to establish the scope of discovery.  We can’t help but be intrigued with any process which has as a component setting boundaries on discovery.  Realistically, particularized rulings on plaintiffs’ claims could lead to less discovery.  For instance, certain time periods could be deemed out of bounds.  Or, if design defect claims are dismissed, that might limit the amount of research and development discovery that is warranted.  Furthermore, tethering the discovery to the claims of 12 actual plaintiffs, regardless of the rulings on the motions, could also be potentially helpful to defendants.  Often, discovery against the manufacturer in an MDL tosses open the doors to the company at large because plaintiffs claim they are taking discovery for all plaintiffs, for all purposes, for all claims, for all times.  Putting discovery in context, including the context of 12 individual plaintiffs, almost always inures to the benefit of the defense.  For our readers who spend a significant time slogging it out with plaintiffs on discovery disputes, we’ll keep our eyes on whether this discovery bellwether generates any useful precedent or tips going forward.

Now to turn to the substance.  Plaintiffs in the Tepezza MDL allege “hearing loss and/or tinnitus” from the use of an FDA-approved prescription biologic for thyroid eye disease.  Defendants challenged the bellwether plaintiffs’ failure to warn, design defect, and fraudulent misrepresentation.  They won one, lost one, and split one. 

On failure to warn, defendant argued that the claims were preempted because plaintiffs failed to adequately plead that defendant could have used the CBE process to change its label before September 2022—after plaintiffs had stopped their treatment.  First, we should point out that while Tepezza is a biologic, the CBE regulation is substantively identical to that for prescription drugs.  So, to avoid preemption, a plaintiff “must plead that the manufacturer had newly acquired information that showed a causal association between the drug and an effect that warranted a new or stronger warning, precaution, or adverse reaction in the label.”  In re Tepezza, at *4.  In that situation, the manufacturer does not need FDA approval to change its label; therefore, no preemption.  Here, plaintiffs cited to a clinical study that came out in September 2020 that showed a sufficient increase in the incidence rate to arguably satisfy the CBE requirements.  Id. at *5.  Defendant argued that the study could not form the basis for a CBE label change because it was not a “clinical trial,” but the court found “criticism of the quality of [the study] . goes to the sufficiency of the evidence proving the allegations, not the sufficiency of the allegations.  Since all of the bellwether plaintiffs used Tepezza after September 2020, their failure to warn claims were not preempted at the pleadings stage. 

On design defect, plaintiffs failed to meet the TwIqbal pleading standard.  In fact, plaintiff only made boilerplate allegations offering no facts and giving the court no basis from which to infer what aspect of the product makes it defective.  Plaintiffs tried to argue that under at least Florida and New York law, they didn’t need to allege a design defect before discovery because they do not have the technical information required to do so.  However, plaintiffs relied on cases in which the complaints contained many more factual details than they allege here.  Plaintiffs don’t have to prove a specific defect in their complaint, but they have “to do more than assert the conclusion that Tepezza is defective.”  Id. at *7.  Plaintiffs’ allegations about dosage were not supported by the evidence they pointed to in the complaint.  Moreover, simply alleging that dose is too high does not satisfy the need to allege an alternative design.  Id. at *9.  With design defect dismissed, plaintiffs asked for permission to amend their complaints—long after the MDL deadline to do so.  They claimed that they had new evidence that defendant was conducting a clinical trial on a new delivery method.  Not only was the study announced months before the pleadings deadline, but it was also not scheduled to be completed until 2026 and had no safety or efficacy results as of yet.  The ”mere initiation of a study” does not “plausibly suggest” a defect in the current delivery method or indicate that the method being studied will turn out to be safer or more efficacious.  Plaintiff did not offer good grounds for their motion to amend, and it was denied.

That left only plaintiffs’ fraudulent misrepresentation claim which was essentially the same as their failure to warn claim.  Plaintiffs’ fraud claim was based on two allegations—that defendant overstated the efficacy of the biologic and defendant misstated the incidence rate.  Applying Rule 9’s heightened pleading requirement for fraud, the court found both allegations were lacking.  The first was simply not supported by any factual allegations (“plaintiffs’ allegations regarding efficacy are highly generalized”).  Id. at *10.  As to the second, plaintiffs had conflicting allegations, including statements that the incidence rate on the label was accurate.  “So, Plaintiffs’ assertion of falsity is not well pled.”  Id. at *11. While the fraud itself was not sufficiently pleaded, the court found plaintiffs’ fraud damages need not be pleaded with particularity.  And defendants raised one more issue—that because the fraud claim is based on the FDA-approved label, it is actually a preempted fraud-on-the-FDA claim.  Here the court concluded it had insufficient information on which to base a decision. Because the fraud claim is substantively the same as the failure to warn claim, a ruling on Buckman preemption would not change the scope of discovery, and therefore the court deferred the issue.  So, on fraudulent misrepresentation the final ruling is defendant’s motion to dismiss is granted in part (fraud allegations), denied in part (damages); and continued in part.  Except as to the Pennsylvania plaintiff because Pennsylvania does not recognize fraud claims based on a failure to warn theory.  Her claim was dismissed with prejudice. 

Like we said, a 50/50 split decision on the claims—but a possible case to watch for discovery. 

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Back in 2008, we wrote a post, No, Bu shi, Non, Iie, Nada, Nyet…., collecting a significant body of law holding that overseas defendants are not required to translate, at their expense, documents prepared in their non-English home languages.  The other day we came across Sessoms v. Toyota Motor Sales, U.S.A., Inc., ___ S.E.2d ___, 2024 WL 5249823 (N.C. App. Dec. 31, 2024), reversing yet another order that a foreign defendant pay for translating its own documents:

[W]e conclude the trial court erred by requiring the . . . Defendants to create new documents in English of documents already provided that are in the Japanese language.  Rule 26 of our Rules of Civil Procedure allows a party to seek documents in the possession of the adverse party; it does not generally require the adverse party to pay for any said documents to be translated into the English language.  In other words, there is no duty to produce documents that do not exist.

Id. at *2 (citation omitted).  Sessoms was “persuaded by what we perceive to be the greater weight of authority in the United States that a party producing documents is not required to create new documents consisting of English translations of documents already provided.”  Id. at *3.  Sessoms cited eight cases exemplifying that “authority” – three of which were decided after our 2008 post.  That suggests that the post could use an update.

So here’s that update.

Continue Reading Still Nyet, Defendants Not Required to Pay for Translation of Documents
Photo of Eric Hudson

We write a lot about the learned intermediary rule. There are 50 state surveys and  summaries of helpful decisions, as well as numerous posts on state-specific decisions. We tracked the development of the rule in jurisdictions like West Virginia and Arizona, and we’ve generally been pleased to report positive developments. At the end of 2024, though, we flagged the Himes case from California as one of the ten worst decisions of the year based on its novel approach to warnings causation.  Given our criticisms of Himes, we found it both bizarre and troubling to see the case cited recently by an MDL court in Massachusetts applying Pennsylvania law. Our colleagues in the plaintiffs’ bar are clearly advocating to expand Himes into other jurisdictions, and the defense bar should be ready to counter those efforts.

Continue Reading Himes Makes a Sneak Appearance on the East Coast
Photo of Eric Alexander

This time of year, many of us are focused on the NFL playoffs.  For someone who watches the Super Bowl for the commercials or the halftime show, which team wins may not matter much.  For those devoted to a particular team, however, there is one possible result that will be truly satisfying.  The reality is that, the fans of 96.875% of the teams end the season with dissatisfaction and those of 92.857% of the playoff teams end the season with an excruciating loss.  Of course, there are those who can find something positive from a non-championship season.  Maybe the fan’s favorite team showed a big improvement over the prior season or the team finally found a franchise quarterback, either of which could lead to optimism for the next season, even though it will probably result in another non-championship.

In the world of product liability MDLs, way more than 99% of the cases filed end in dismissal.  In any given MDL, very few, or perhaps none, of the cases that the plaintiff lawyers file will result in judgment for the plaintiff.  Of course, the path to and nature of the dismissal will determine how the parties and their counsel feel about it.  A dismissal in connection with a settlement or a dismissal without prejudice will not be as dissatisfying for the plaintiff as a dismissal with prejudice after summary judgment or a defense verdict at trial.  For the defendants in an MDL, the reality is that satisfaction is affected by a range of economic considerations.  Managing an MDL where the vast majority of cases essentially sit around for years waiting for settlement requires a focus on the big picture as well as the case count.

Subject matter jurisdiction in a product liability MDL will almost always be based on diversity and the defendant will usually prefer that any given case within the MDL’s definition proceed in the MDL instead of in state court.  There is a clear gap in the proceeding statements.  A plaintiff with the same state of residence as the defendant(s) cannot stay in federal court based on diversity jurisdiction, and there is no special federal jurisdiction for MDL courts.  In In re Cook Med., Inc., IVC Filters Mkt’g, Sales Pracs. & Prods. Liab. Litig., MDL No. 2570, 2024 U.S. Dist. LEXIS 235780 (S.D. Ind. Nov. 14, 2024) (“Cook”), the defendants succeeded in getting the cases of eleven plaintiffs from Indiana, where the defendants are also based, dismissed without prejudice for lack of subject matter jurisdiction.  That is only part of the story.  The plaintiff lawyers admitted they did not have diversity jurisdiction for these cases when they were directly filed in the MDL and no other basis for keeping the cases in the MDL.  And they refused to dismiss the cases when requested.  So, the defendants sought Rule 11 sanctions in connection with the dismissals.  This was largely symbolic because they sought only the costs of bringing the motions to dismiss in nine cases and later reduced the request to $100 per case.  They apparently did not pursue other avenues for sanctions or costs, probably because Rule 11 allows sanctions to be awarded against an attorney or law firm, not just against a party.

The Cook court denied sanctions.  While the plaintiff lawyers had no argument about jurisdiction, their excuse for refusing to voluntarily dismiss when requested was that Indiana’s savings clause would not provide a year to re-file if the dismissals were voluntary.  The court thus saw the refusals to dismiss as not being sanctionable because they were “in the best interest of Plaintiffs, their clients.”  2024 U.S. Dist. LEXIS 235780, *4.  Here is the problem with that decision.  The cases were directly filed in the MDL in 2018 to 2020, several years after the MDL was established.  [We have tracked various rulings from and related to this MDL over the years, like here, here, here, and here.]  Subject matter jurisdiction is measured at the time the case is filed in or removed to federal court.  Plaintiff lawyers should know the law well enough to ensure that they do not file time-barred cases and/or cases in courts without jurisdiction.  There would have been no need to use the Indiana savings clause if the cases had been timely filed in Indiana state court originally or if the mistake of filing in the MDL had been discovered before the statute of limitations expired.  These cases were pending in the wrong court for four to six years before the savings clause became the excuse for forcing motions to dismiss to be filed.  When the court had to rule on those motions and the attendant obvious sanctions issue, the delay should not have been exculpatory.  After all, the Cook court did find that the plaintiff lawyers “should have realized that Plaintiffs’ cases did not fall within the diversity jurisdiction of this court,” a determination that would have applied at all points from before filing until the ultimate dismissal.  Id. 

Sanctionable conduct by a lawyer should not get a retroactive blessing if it persists long enough to hurt the lawyer’s clients.  Nor is the consideration that sanctions “can affect the reputation and creativity of counsel” usually going to be sufficient for an MDL to refrain from sending the message that filing frivolous cases and refusing to dismiss them is sanctionable.  Id. (quoting from Hartmarx Corp. v. Abboud, 326 F.3d 862, 867 (7th Cir. 2003)).  Indeed, because the savings clause would not resurrect a case that was untimely when filed, if any of these cases were filed in the wrong court after the statute of limitations had expired, then the much later refusal to dismiss served no interest of the lawyer’s client.

By contrast, just about any unsupportable claim or position advanced by a plaintiff lawyer could be said to be done in the “best interest” of the lawyer’s client, who presumably wants to win a big award or secure a big settlement.  That may be why Rule 11 has no provision that excuses unsupported representations to the Court—such as a jurisdictional allegation in a complaint—based on the interest of the party on whose behalf the representation is made.  It does specify, however, that any “sanction imposed under this rule must be limited to what suffices to deter repetition of the conduct or comparable conduct by others similarly situated.”  Fed. R. Civ. P. 11(c)(4).  In the context of an MDL, trying to deter the direct filing of cases without subject matter jurisdiction makes sense.

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