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We’ve written before about the long-running Muldoon v. DePuy Orthopedics lawsuit.  For one thing, it’s been around forever – its facts are almost as old as the Blog.  As we stated here:

Muldoon . . . is a suit over hip-replacement surgery conducted in 2007.  Suit was not filed, however, until 2015 – undoubtedly Muldoon is another example of the flotsam and jetsam dredged up by MDL lawyer solicitation.  So Muldoon was stale from the beginning.  But it got worse. For some eight years, Muldoon sat in the horribly mismanaged Pinnacle Hip MDL in Texas.  It appears that nothing at all happened during those years . . . [until] 2023, when the case was ultimately remanded, without comment.  So, due to the combined lassitude of the plaintiffs and MDL management, the suit is nearly 14½ years post-surgery, and only now being addressed on the pleadings.

(citations and quotation marks omitted).

Finally, in Muldoon v. DePuy Orthopaedics, Inc., 2025 U.S. Dist. Lexis 34013 (N.D. Cal. Feb. 25, 2025), it was dismissed with prejudice.  And in the end, the plaintiff didn’t even put up a fight.  Faced with the defendant’s latest dismissal motion, “[p]laintiff has declined to file any opposition.”  Id. at *2.  What was at stake this time were the claims that had survived the defendant’s first dismissal motion against the plaintiff’s absurdly excessive 18-count post-MDL amended complaint.  We had some words to say about that complaint as well:  “It is a dog’s breakfast.  Or it is what our dogs deliver to our yard right after consuming their breakfast.”

Continue Reading Muldoon Dismissed – The End of an Error?
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Today’s case has shocking facts but not a shocking result. It should come as no surprise that a complaint attacking the safety of an FDA-approved Class III medical device is squarely preempted by the express preemption provision of the Medical Device Amendments, 21 U.S.C. § 360k(a). But somehow, 17 years post-Riegel, that still does not seem to deter plaintiffs from filing plainly preempted claims.

Continue Reading No Shock Here: D. Mass. Holds Complaint Regarding Class III Medical Device Preempted
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In Hall v. Walgreens Boot Alliance, Inc., the Supreme Court of Washington considered a certified question from the Northern District of Illinois on an issue of Washington state law.  No. 102829-6, 2025 Wash. LEXIS 145 (Wash. Mar. 20, 2025).  The underlying case, a proposed consumer protection class action, involves the labeling of a certain over-the-counter cough syrups.  We have seen several cases like this, most often when they have been decided on preemption.  For quite some time, in posts on a wide range of cases, we have pushed two related propositions:  1) a proper preemption analysis should usually start with determining if the asserted state law claim is cognizable as stated before dealing with preemption; to do otherwise invites reverse engineering a non-preempted claim beyond the scope of state law; and 2) when a federal court is sitting in diversity, the Erie doctrine requires that the court not substitute its judgment on what it thinks the state law show be.  Taken together, these propositions favor the use of certified questions to first determine whether state law would provide the relief plaintiffs seek if not for the possibility of preemption.  So, we think it made sense for the Northern District of Illinois to ask the Supreme Court of Washington to determine how the safe harbor in the Washington consumer protection act applied to plaintiffs’ OTC drug labeling claims before deciding if those claims are preempted.  We wish it did not take three years to get this far, but, like arithmetic and assembling items shipped in pieces, the order of operations matters.  Because the actual decision from the Supreme Court of Washington is so obviously wrong, we will have to take solace in the order of operations.  That and how this claim is even more obviously preempted, which seems like the logical next step.

The term “safe harbor” has been applied to a number of things in the legal and real world.  For a long time, fights over off-label promotion turned on compliance with FDA’s safe harbors about when and how requested off-label use information could be shared.  State consumer protection acts, which can be worded so broadly as to make all sorts of benign conduct actionable, also often include their own safe harbors on when conduct that has been blessed by a governmental entity in some form or fashion is deemed, well, safe.  When the artist formerly known as Bexis put together a list of these provisions eleven years ago, we/he had this to say about the Washington law that would become the focus in Hall:

Some state’s statutes exempt conduct in “compliance” with relevant governmental oversight, which we’re taking to mean “FDA,” regulations (Alabama, Colorado, Delaware, Georgia, Hawaii, Illinois, Maine, Minnesota, Nebraska, Nevada, Ohio, Oregon).   Other states exempt anything “permitted” by the relevant regulatory body (Arkansas, Connecticut, Indiana, Maine, Massachusetts, Montana, Nebraska, New Mexico, Ohio, Rhode Island, South Carolina, South Dakota, Utah, Wyoming).   Some states qualify their safe harbors with modifying adverbs, such as “specifically,” “expressly,” or “affirmatively” (Florida, Georgia, Idaho, Illinois, Indiana, Michigan, New Mexico, Ohio, Tennessee, Utah).  A broader formulation exempts anything that is government “regulated” (Alaska, Nebraska, Oklahoma).  A narrower formulation exempts only conduct “required” by the regulator (Florida, Idaho, Indiana, Ohio, Utah, Wyoming). Another variant is “authorized (with or without adjectives) (Illinois, Michigan, Tennessee, Virginia), or alternatively “authorized or approved” (Kentucky).  Then there are New York (“subject to and complies with”), Washington (“permitted, prohibited or regulated”) and California (a common-law carve out for “business practices which the Legislature has expressly declared to be lawful in other legislation,” see Cel-Tech Communications, Inc. v. Los Angeles Cellular Telephone Co., 973 P.2d 527, 542 (Cal. 1999)), which don’t follow anybody else’s pattern.

With all due respect to the grouping in the prior post, the safe harbor in the Washington consumer protection act, although really poorly written, appears to differentiate based on which governmental entity is providing oversight for the challenged activity.  It starts off by saying that the chapter does not apply to “actions or transactions otherwise permitted, prohibited or regulated under laws administered by the insurance commissioner of this state, the Washington utilities and transportation commission, [strangely missing conjunction] the federal power commission.”  Revised Code of Washington 19.86.170 (emphasis added; conjunction not supplied).  It continues, without punctuation or numbering, with “or actions or transactions permitted by any other regulatory body or officer acting under statutory authority of this state or the United States.”  Id. (emphasis added;strange ending colon converted to a period).  Then follow a number of exceptions and exceptions to exceptions that appear inapplicable to the apparent catchall for a federal regulator unless the “actions and transactions [are] in connection with the disposition of human remains.”  The certified question in Hall was whether, under this murky safe harbor, “labeling as ‘non-drowsy’ an over-the-counter antitussive containing dextromethorphan hydrobromide an ‘action[ ] … permitted by … [a] regulatory body … acting under statutory authority … of … the United States’ such that this labeling decision falls within the statutory safe harbor?”  We are not sure this is the right question, but it is not really the question the Supreme Court of Washington answered.

The question of Washington law really was what is required for a safe harbor based on a non-enumerated federal agency such as FDA.  The question of application and implication to the underlying proposed class, which was reserved by the Northern District of Illinois, was whether FDA’s actions with regard the labeling of the OTC cough syrups met the proper safe harbor standard.  A brief detour to Hall’s allegations about the products and FDA’s role is required.  We say brief in part because the opinion clearly presented any incomplete, plaintiff-friendly view of FDA’s role; the concurrence has a somewhat more thorough examination of monographs, as well as the history of the consumer protection act and its safe harbor provision.  A deep dive into monographs and OTC drug regulation in general is beyond our scope here, but we can say that the regulatory scheme applicable to plaintiffs’ theory is more involved than whether the applicable monograph directly says products with the particular active ingredient at issue in the case can be labeled “nondrowsy.”  2025 Wash. LEXIS 145, *3.  The putative class rep bought “one of these over-the-counter cough medicines”—presumably one labeled as “nondrowsy” although the class allegations cover multiple products with and without the designation—allegedly became “unexpectedly drowsy,” and sued because “drowsiness is a known side effect of medicines containing dextromethorphan hydrobromide.”  Id. at *2.  This case, of course, has all the hallmarks of a lawyer-driven litigation with no real aim but to force a settlement over a non-issue that produced no injuries.  The angle the lawyers like is that the FDA monograph requires OTC cough syrups with diphenhydramine to come with a drowsiness warning, but does not say if the ones without diphenhydramine can identify themselves as nondrowsy.

For the Supreme Court of Washington in Hall, the safe harbor was interpreted narrowly to help to “accomplish [the statute’s] beneficial purposes of protecting the consumer.”  Id. at *5.  That led it to read the statutory provision “actions or transactions permitted” as requiring that “an agency must take ‘overt affirmative actions specifically to permit the actions or transactions engaged in’ by the person or entity involved in a Consumer Protection Act complaint.”  Id. at *7 (emphasis added and internal citation omitted).  Noting that the statute states that specified regulatory entities are covered by the safe harbor based on actions they “permitted, prohibited or regulated,” the difference in phrasing for other regulatory entities means “that the legislature intended the statutory safe harbor for activities regulated by nonenumerated agencies to be limited to actions or transactions expressly permitted by the agency.”  Id. at *8-9.  One problem with this analysis is that states that wanted to make a safe harbor be tied to actions “specifically,” “expressly,” or “affirmatively” permitted by a regulatory agency, such as Florida, Georgia, Idaho, Illinois, Indiana, Michigan, New Mexico, Ohio, Tennessee, and Utah per our old post, actually used those adjectives in the drafting of their own safe harbor provisions.  Interpreting “permitted” to mean the exact same thing as “specifically permitted,” “expressly permitted,” and “affirmatively permitted” does not make much sense, especially when it comes to a regulatory scheme as complicated as applies to monograph OTC drugs.

Hall went a step further and concluded that “[a]s FDA has not specifically permitted labeling these over-the-counter drugs nondrowsy, that activity falls outside the statutory safe harbor.”  Id. at *10.  We can quibble with that conclusion, but it also clear that removing the word “specifically” from standard—that is, making the standard match the statute—should lead to the opposite conclusion.  This is certainly not the first time that a court has contracted its safe harbor to allow a dubious consumer protection case about a drug to proceed.  Here, however, the issue of whether the state law claim is preempted by the FDCA is still alive.  Consumer protection claims are not saved from express preemption under 21 U.S.C. §379r, and the plaintiffs’ claim is Hall is clearly based on a state requirement that is “different from or in addition to, or that is otherwise not identical with” federal requirements.  We would say that means express preemption is a slam dunk, but even dunks get blocked sometimes.

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You can find useful legal precedents in surprising places.  For example, Schmidt v. Schmidt, 2025 Pa. LEXIS 389 (Pa. March 20, 2025), is an interesting off-label use decision coming in a context that that most litigants of such cases will miss: a workers’ compensation case.  But if you have been following this blog, Schmidt will not be much of a surprise, because we covered the earlier ruling in that case here.  In that earlier ruling, a majority of the Pennsylvania Commonwealth Court held that where a doctor prescribed a cannabis oil (CBD) to a workers’ compensation claimant for treatment of pain from a workplace injury, the purchase of the CBD is reimbursable by the workers’ compensation system.  The workers’ comp board had denied coverage, leaning heavily on the refusal of the Food and Drug Administration (FDA) to approve medical use of CBD.  The Commonwealth Court overturned the workers’ comp board.  The majority opinion reasoned that the FDA’s non approval of CBD (indeed, the FDA had even pursued off-label prosecutions against some CBD sellers), did not affect the legality or reimbursability of the CBD in this case.

Now the Pennsylvania Supreme Court has unanimously affirmed the Commonwealth Court and held that an off-label use of the CBD (a use that the FDA “has concluded that it has not been proven safe or effective”) does not make prescription of the product illegal.  That’s right, the employer in Schmidt made essentially the same off-label = illegal argument that we DDL bloggers have been opposing since the Bone Screw litigation of the 1990s. That argument failed then, in the context of product liability/medical malpractice. See Southard v. Temple Univ. Hosp., 781 A.2d 101, 104 (Pa. 2001). In Schmidt, the same argument failed in the context of workers’ compensation. Schmidt held that a compensable treatment need not be approved by the FDA or even regulated by the FDA at all.  “FDA approval of a treatment is not a requirement under the [statute], and despite that the FDA has not approved some firms’ marketing of CBD oil as a dietary supplement, its use is not otherwise illegal.”  CBD oil is lawfully sold over the counter in Pennsylvania. The Pennsylvania Supreme Court saw its task in this case as statutory interpretation, and read the statute to mean that “any item that is part of a health care provider’s treatment plan for a work-related injury falls within the purview of the broad-encompassing phrase ‘medicines and supplies’ in the statute.”  The Supreme Court also held that the claimant was not a “provider,” and therefore did not need to submit specific paperwork containing detailed billings and service codes.  It was a complete win for the claimant.

And now we cannot resist saying a few words about the claimant’s story.  You might have noticed that this is one of those cases with the same name on both sides of the v.  One inevitably thinks of Jaurndyce v. Jaurndyce, the lawsuit in Bleak House that droned on for decades and visited ruin on all parties.  In Schmidt, the plaintiff was a lawyer at a law firm bearing that same name.  Is the plaintiff a name partner in the law firm?  A relative?  Merely someone with the same name?  (We work at a law firm with very common names above the door and at the top of the stationery.  Surely, some luckily surnamed young lawyers have joked to their friends and family that they immediately stepped in as name partners at an AmLaw 100 firm.) In any event, the Schmidt plaintiff was in the workers’ comp system because of a work-related – here, legal work-related – injury.  Specifically, the claimant “was squatting to load files into a trial bag, tipped the trial bag onto its wheels, experienced ‘a sudden sharp increase in low back and right leg pain,’ and fell over onto his side.”  One sympathizes.  A workers’ compensation judge described the work-related injury as “an aggravation of his preexisting degenerative disc disease at L4-5 and L5-S1 with radiculopathy.”  It was a serious injury and the pain “progressively worsened.” The claimant desired “to exhaust all non-surgical options before undergoing surgery due to the inherent risks associated therewith and the likelihood of a prolonged recovery time.”  He took opioids multiple times per day.  Nevertheless, the “extensive driving and sitting in courtroom chairs associated with Claimant’s employment continued to aggravate his pain.”  Again, one sympathizes.  At this point, the claimant’s doctor prescribed the CBD oil.  The hope was that it would alleviate the pain and avoid the need to up the opioid doses.  The good news was that the CBD oil seemed to work.  The bad news was that the employer did not wish to pay for it.  And then the claimant got the adverse ruling from the workers’; comp board, followed by the favorable rulings from the Commonwealth and Supreme Courts.  And we DDL hacks got a favorable ruling we might be able to use when plaintiffs seek to demonize alleged off-label use.

But the Schmidt decision also got us to thinking about legal work-related injuries.  We are now at an advanced age when we can tweak our back without any hint of trauma.  Merely sitting down or reaching for our phone can invite back spasms. One time in our office we were beset by such excruciating back pain that we felt utterly immobilized. We pondered the prospect of planting ourselves at our desk for hours or days, reading advance sheets until some sweet release ended the pain. But it is not as if we can pinpoint any pain to a certain event, such as the Schmidt claimant’s battle with a recalcitrant trial bag.  Thinking back, we can dimly recall moments in court when we might have torn a meniscus by leaping to a conclusion, or sprained a ligament by stretching an argument.  Moreover, the occasional judicial slap-down has, at a minimum, hurt our feelings.  But we doubt that even the magnanimous Pennsylvania Supreme Court would deem any of that compensable by workers’ comp or any system.  If any of you know of weird legal work-related injuries, send them in to us.  As Nora Ephron said, “everything is copy.”  If we get enough legal injury tales of woe, we can turn them into a blogpost.  It might not be a particularly instructive blogpost, but we could all benefit by stretching our powers of sympathy.  Or maybe it would just add up to schadenfreude, which also has therapeutic value.  

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That concept does not feel like it should be controversial in any way.  Afterall, at the heart of class action tolling of the statute of limitations, as announced in American Pipe & Construction Co. v. Utah, 414 U.S. 538 (1974), is there must be a pending class action.  But the concept gets a little muddy in the mass tort context, which is why we’ve previously argued for an MDL exception to American Pipe.  Today’s case is a clear example of why. 

First, some background on American Pipe.  The Supreme Court held that “the commencement of a class action suspends the applicable statute of limitations as to all asserted members of the class who would have been parties had the suit been permitted to continue as a class action.” Id. at 554. The Court’s reasoning was based on efficiency and economy.  It was trying to avoid unnecessary filings by absent class members while simultaneously protecting those class members.  The tolling runs while the “class” portion of the suit is pending.  So, if class certification is denied or if the class claims are dismissed, American Pipe tolling ends. 

But what happens when a putative class action gets transferred into an MDL and abandoned by the plaintiffs who filed it?  That was the issue facing the First Circuit in MSP Recovery Claims, Series LLC v. Fresenius Med. Care Holdings, Inc., — F.4th –, 2025 U.S. App. LEXIS 6243 (1st Cir. Mar. 17, 2025).  Now a procedural rundown, which is always important in American Pipe tolling cases:  (1) in 2012, defendants publicly announced that its drug used in hemodialysis could lead to cardiopulmonary arrest in certain patients; (2) in 2013, a group of nine plaintiffs filed a nationwide products liability class action; (3) the putative class action, along with individual claims, were transferred to the District of Massachusetts as part of an MDL; (4) plaintiffs filed a master complaint in the MDL that did not contain any class allegations; (5) in February 2014, the MDL court entered a case management order directing each plaintiff to file a short form complaint that would “incorporate the Master Complaint and replace that party’s original complaint”; (6) between March and June 2014, four of the plaintiffs to the putative class action voluntarily dismissed their claims and the other five filed short form complaints on behalf of themselves or next of kin only that did not contain any class allegations; (7) on September 6, 2018 MSP files its class action complaint; (8) following a private global settlement the 2013 class action was closed in April 2019.  Id. at *4-5.

There was no dispute that under any state’s law, MSP’s claims were time barred unless saved by American Pipe tolling.  It was also undisputed that as of June 2014, the MDL court no longer had before it any class action claims.  But here is the muddy part.  The MDL court in a later proceeding inquired about whether the 2013 class action was still “hanging out there.”  Id. at *5.  The plaintiffs’ leadership responded that counsel was:

not planning on moving for certification, and that these cases were filed, for the most part, with respect to the issue of equitable tolling for the purposes of the limitations period, and for now our preference is to just leave them as they are.

Id. at *5-6.  And that is exactly what happened for five years.  The class action sat.  No plaintiff took any action to move the class claims forward and never sought class certification.  Yet, MSP argued that the statute of limitations was tolled until the class complaint was finally dismissed in 2019.  Defendant argued that the earlier case lost is “class character” at the latest in June 2014 and that is when tolling ended—more than four years before MSP filed its complaint.  The court agreed with defendant. 

MDL plaintiffs may elect to file a master complaint.  If they do, the “master complaint supersede[s] prior individual pleadings.”  Id. at *12.  Therefore, when the original class plaintiffs filed individual short form complaints, those new complaints replaced the class action which became inoperative.  Further, the short form complaints adopted the master complaint which also did not contain any class allegations.  Id. at *13. 

While that should have ended the inquiry, the appellate court acknowledged the complexities of MDL litigation and was unwilling to ignore that the MDL court did not consider the request for class certification “entirely abandoned” but rather “held in a form of abeyance, not because plaintiffs were actually pursuing class certification, but as a tool for tolling the statute of limitations.”  Id. at *14 (emphasis added).  So, the court considered the question before it to be whether an otherwise-abandoned request for class certification held in limbo for the sole purpose of tolling the statute of limitations did in fact have such a tolling effect.  The answer was no:

To allow such a gambit to substitute for pleading and actively pursuing a class action would run contrary to the aims of American Pipe, the “watchwords” of which are “efficiency and economy of litigation.” Neither efficiency nor economy is furthered by holding a request for certification on inactive life support simply to delay indefinitely the need to bring forward individual claims.

Id. at *17 (citation omitted). 

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The plaintiff in Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), lost the bulk of her case recently, on a motion to dismiss no less.  In this case involving surgical staples, strict liability and negligence claims (which, in New York, are “functionally synonymous,” id. at *18) for design and manufacturing defects bit the dust.  Some unusual fact questions also remained open, neither of which bode well for the plaintiff: (1) was the surgeon that wrote the operative report “even present” for the . . . the surgery”; and (2) why did the surgeon report a “malfunction” to a representative of a different surgical stapler manufacturer, instead of any of the defendants?  Id. at *14-15.

Kane also involved the usual plaintiff failure to plead anything of substance about the purported “defects” in the defendant’s stapler, but some of the additional reasons for dismissing plaintiff’s claims are quite interesting.

New York is one of those sensible states that requires a plaintiff attacking a product’s design to put up or shut up, with a feasible alternative design.  Id. at *19.  “A design defect claim is subject to dismissal where the plaintiff fails to allege with sufficient specificity how the design is defective or identify the existence of a feasible alternative design.”  Id. at *19-20 (citation and quotation marks omitted).  The plaintiff must also plead that “product as designed posed a substantial likelihood of harm,” and causation.  Id. at *19.

Plaintiff struck out, primarily because, rather than identifying a supposedly feasible alternative design and asserting product-specific facts, she launched an unfocused attack on surgical staplers generally, regardless of who made them.  That attack was not persuasive.

Based on [plaintiff’s] description, however, the statistics referenced appear to concern surgical stapling devices generally, not necessarily the specific Surgical Stapler at issue here.  Moreover, the Amended Complaint’s allegation that 60 mm staplers have a higher propensity for failure is insufficient to establish that [this device’s] 60 mm specification is an “unreasonably dangerous” design defect as opposed to a necessary feature for serving its function.

Kane, 2025 U.S. Dist. Lexis 25718 at *20-21 (citations omitted).

We’ve pointed out before that New York federal courts are known for their excellent TwIqbal jurisprudence.  Kane is another example.

Nor does the bare existence of other staple sizes qualify as a viable alternative design:

[Plaintiff’s] allegation that [other sized] stapling devices exist does not establish that such devices would be a “reasonable alternative design”. . . .  The Amended Complaint does not address what range of staple heights would be compatible with [the] stapling . . . done during [this] surgery.  In other words, it does not plead facts showing that [other sized] stapling devices would be reasonable alternative designs for use in the type of . . . surgery.

Id. at *21 (citations and quotation marks omitted).  Because some sizes of staples are “incompatible with a specific tissue’s thickness and biochemical properties,” plaintiff’s broad-brush claims didn’t cut it under TwIqbal.  Id.

Nor did the surgeon’s notes of a “stapler failure” suffice to plead causation.  While the cryptic note was “enough” to support an “inference” that the failure caused an injury to the plaintiff, that wasn’t enough under New York (or any other state’s) law to state a prima facie case of liability.  No – the failure that caused the claimed injuries must have been the result of a defect.  Id. at *23 (“they do not establish that a design defect caused the Surgical Stapler failure”) (emphasis original).  Nor did plaintiff plead any facts linking the decedent’s death, “approximately three months” later, to anything related to the surgery.  Id.

Having failed to plead any factual allegations concerning the cause of the Surgical Stapler failure and the death . . ., all that is left in the Amended Complaint is the conclusory allegation that “[decedent] died . . . as a result of the carelessness, recklessness, unskillfulness, manufacturing defect, and/or negligence of Defendants.”  This is not sufficient to state a claim for design defect.

Id.

The manufacturing defect claim was also TwIqballed – for much the same reason.  Plaintiff in Kane pleaded no more than “a staple failure” caused injury.  2025 U.S. Dist. Lexis 25718 at *24.  Without excluding other causes, that’s not enough for a plausible manufacturing defect claim.  Plaintiff did “not allege that all potential causes of . . . failure other than manufacturing defect, such as, for example, user error, have been eliminated.”  Id. at *25.  Related implied warranty claims failed for the same reasons.  Id. at *30.

The only claim that survived in Kane was a warning-based claim mostly centered around the defendant’s alleged use the FDA’s alternative summary reporting (“ASR”) system for reporting adverse events.  Id. at *26-27.  As we’ve discussed elsewhere, such claims are utterly meritless, for several reasons.

First, the FDA wanted manufacturers of select products to use this program, which it invented to handle well-known types of adverse events.  That means that claims asserting liability for doing what the FDA wanted should be preempted.  See Bexis’ Book at §5.01[3] n.150.1, §5.02[4][e][iii] n.369 (collecting reporting related preemption cases sounding in both express and implied preemption).

Second, an ASR-based failure-to-report claim is still a failure-to-report claim, which in New York (as in most other states) is not a recognized form of warning claim under state product liability law.  See our 50-state survey of failure-to-report claims.  The following precedent holds that no reporting-based warning claims exist under New York law:  Mitaro v. Medtronic, Inc., 900 N.Y.S.2d 899, 899 (N.Y.A.D. 2010); Lake v. Kardjian, 874 N.Y.S.2d 751, 755 (N.Y. Sup. 2008); Tillet v. CooperSurgical, Inc., 2023 WL 4704091, at *4-5 (W.D.N.Y. July 24, 2023); English v. Bayer Corp., 468 F. Supp.3d 573, 580 (W.D.N.Y. 2020); Trisvan v. Heyman, 305 F. Supp.3d 381, 402 n.16 (E.D.N.Y. 2018); Pearsall v. Medtronics, Inc., 147 F. Supp.3d 188, 201-22 (E.D.N.Y. 2015); Teixeria v. St. Jude Medical, Inc., 2015 WL 902616, at *8 (Mag. W.D.N.Y. March 3, 2015), adopted in part and rejected in part on other grounds, 193 F. Supp.3d 218 (W.D.N.Y. 2016); In re Consolidated Fen-Phen Cases, 2003 WL 22682440, at *6-7 (E.D.N.Y. Nov. 12, 2003).  There are also quite a number of New York decisions rejecting reporting-based tort claims in non-FDA contexts, as listed in our survey.

Third, the next surgeon who relies upon public FDA adverse event reporting (the so-called MAUDE database) to select an appropriate stapler will be the first.  Thus, even if such a cause of action existed, failure to report could not possibly be causal.  We discussed causation issues here.  That’s precisely what happened to the identical claim in Corrigan v. Covidien LP, 748 F. Supp.3d 1 (D. Mass. 2024), which we discussed in detail here.

As in Kane, an ASR-based warning claim in Corrigan escaped dismissal on the pleadings, based on factual allegations that subsequent discovery showed to be false.  Corrigan v. Covidien LP, 2022 U.S. Dist. Lexis 210296, at *17 (D. Mass. Nov. 21, 2022).  But when summary judgment time came along – that was the end of the Corrigan ASR failure-to-report claim:

[T]he record is that [the surgeon] did not read, or . . . rel[y] upon adverse events reports, which he did not research beforehand, to influence his decision to use the [defendant’s device].  The Court concludes that [defendant] has rebutted the presumption that [the surgeon] would have heeded any warning and that Plaintiffs have not shown a triable issue of material fact as to causation, specifically as to [defendant’s] instructions or by submitting adverse event reports through the ASR program.

748 F. Supp.3d at 21 (citations omitted).  The record is unlikely to be any different here.  Surgeons have better things to do than pore through MAUDE adverse event records that the FDA itself says are unreliable “to evaluate rates of adverse events, evaluate a change in event rates over time, or to compare adverse event occurrence rates across devices.”  Further, even now the FDA has never considered data submitted through “alternative reporting requirements granted under 21 CFR 803.19 prior to June 2019” to be worth the bother of being added to MAUDE.

The ASR-based failure-to-report claim in Kane thus survived, but realistically all that did was to postpone the inevitable defense win.

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The MSP plaintiffs are at it again, and without success this time around.  In MSP Recovery Claims Series LLC v. Pfizer Inc., 2025 U.S. Dist. LEXIS 38647 (D.D.C. Mar. 4, 2025), the group of law firms formed to file lawsuits under the Medicare Secondary Payer Act (hence the “MSP” in the various plaintiffs’ names) sued a drug manufacturer and other defendants alleging vaguely that payers who assigned their rights to the plaintiffs were defrauded in the purchase of prescription drugs.  As will be seen, that was not sufficient to state a claim.

The MSP plaintiffs got their start by acquiring the rights of private Medicare Advantage payers to pursue reimbursement from primary payers under the Medicare Secondary Payer Act.  They focused initially on the Medicare Secondary Payer Act’s private right of action, but they have branched out since to RICO and other statutory claims.  We have brought you multiple examples, including here, here, here, and here. 

Their record lately is not good, and in the view of at least one district judge, they are wearing out their welcome in our federal courts.  According to this judge, these plaintiffs (essentially “assignee debt collectors”) have “little incentive on the front end” to evaluate their claims and instead “rush to file litigation” in the hope that something sticks.  MSP Recovery, at *2-*3.  This approach “is not sitting well with many judges . . . and has garnered harsh criticism from courts across the country,” where these plaintiffs are “consuming vast judicial resources . . . and imposing enormous burdens on the [judicial] system.”  Id. at *3. 

Gosh judge, why don’t you tell us how you really feel? 

With this warm up, we commend the court for its patience in allowing these plaintiffs three chances to plead valid claims.  But alas, even with that latitude, the plaintiffs could not do it.  The court previously dismissed the entire complaint for lack of standing and then dismissed RICO claims in the First Amended Complaint for failure to state a claim.  As a result, the Second Amended Complaint alleged only state-law consumer fraud, common law fraud, and unfair trade practices claims.  Id. at *3-*4. 

The district court dismissed those claims, too.  To start, the plaintiffs had no standing to bring claims against defendants with relationships only in Rhode Island and California because the plaintiffs did not allege that any of the subject drugs were purchased in Rhode Island or California.  As the court ruled, courts dispense standing to specific plaintiffs and specific claims, not to “groups of plaintiffs ‘in gross.’”  The court further held that the plaintiffs had no standing under Delaware’s laws because the plaintiffs did not allege that any of their assignors was injured in Delaware.  One assignor/payer had enrollees in Delaware, but the plaintiff did not allege that the assignor ever paid for the subject drugs in Delaware, or even that they were prescribed there.  No standing.  Id. at *7-*8. 

Where the plaintiffs did have standing, they failed to meet Rule 9(b)’s heightened pleading standard.  The plaintiffs’ claims clearly sounded in fraud:  The Second Amended Complaint focused on alleged false and fraudulent statements, and although the plaintiffs alleged that the defendants’ alleged conduct ran afoul of other public policy considerations, the underlying factual allegations always came back to alleged false and deceptive statements. 

The plaintiffs therefore had to plead their claims with particularity, which they did not accomplish:  “Although the amendments add length and recharacterize the same factual allegations to make them seem worse, they ‘are lengthy, [but] not specific.”  Id. at *11. 

“Lengthy, but not specific.”  In other words, the plaintiffs said a lot, but they did not provide the who, what, when, and where of the alleged fraudulent statements or conduct.  They emphasized certain more specific allegations of their Second Amended Complaint, but the court saw those paragraphs merely as conclusory assertions of knowledge and intent, without the facts to back them up. 

The court therefore dismissed all the remaining claims and did so with prejudice.  This was the plaintiffs’ third try at pleading and their second opportunity to amend.  Moreover, the “parties have undergone three rounds of briefing with hundreds of pages and tens of thousands of words spent on the motions to dismiss alone.  And as the Court has already outlined, this is not the plaintiffs’ ‘first rodeo.’”  Id. at *13-*14.  As they say in places where rodeos flourish, “This dog don’t hunt.” 

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Taking pot shots at “Big Pharma” is easy.  Crack a joke about Big Pharma and you are sure to get a laugh.  Amirite? 

That is not to say there is never a fair point or two to be made about pharmaceutical development or marketing, or health care and the delivery of same in this country. 

But what never makes sense to us is the idea that our clients deliver products with little to no value.  Direct-acting antiviral medicines can cure more than 95 % of hepatitis C infections.  Incredible advances can help prevent HIV infection and have made HIV infection more treatable.  In 2000, measles was declared effectively eliminated in United States (although outbreaks of the disease are back on the rise because vaccination rates have dropped off). 

The list of amazing progress in medicine goes on and on, and is part of the reason we take umbrage at the “get a name, file a claim” mass tort litigation that proliferates against pharmaceutical and medical device manufacturers.  Using sheer force of numbers to bring litigation based on shoddy science does nothing to help patients who need innovative medical treatments, and carries a very real prospect of driving good medical treatments off the market due to out-of-whack litigation risks.

The Gardasil MDL is a prime example.  This Human Papillomavirus (HPV) vaccine has an incredibly high efficacy rate (close to 100%) for prevention of persistent infection, cervical intraepithelial neoplasia (CIN) 2/3, and adenocarcinoma in situ (you know, cancer) in clinical trials.  Following Gardasil’s introduction to the market, HPV infections that cause most HPV cancers and genital warts in teen girls have dropped 88%, and HPV-linked cervical cancers have dropped 40% in vaccinated women.  So of course the manufacturer is being punished with a federal MDL.

Although the Gardasil MDL should not exist because of the Vaccine Act’s separate compensation system for alleged vaccine injuries, earlier Gardasil MDL opinions have been helpful.  One dismissed claims as untimely and kept the MDL plaintiffs from collaterally attacking Vaccine Court findings.  Another recognized disguised design defect claims as preempted under the Vaccine Act/Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228-30 (2011), dismissed manufacturing defect claims (it is not a manufacturing defect if the criticized aspect of the product is in every single unit), and found direct-to-consumer failure to warn and fraud claims barred by the Vaccine Act.  Another turned aside a constitutional challenge to the Vaccine Act itself. 

And now we have another good decision on implied preemption, one dismissing the remaining claims for all the Gardasil bellwether cases (and other MDL plaintiffs pursuant to MDL procedural orders):  In re Gardasil Prods. Liab. Litig., MDL No. 3036, 2025 U.S. Dist. LEXIS 44376 (W.D.N.C. Mar. 10, 2025). 

The Gardasil MDL plaintiffs  contend they have “postural orthostatic tachycardia syndrome” (“POTS”), which is characterized by dizziness and occasional fainting when standing up, or “primary ovarian insufficiency” (“POI”), which involves lower estrogen or irregular egg release in women under 40.  The MDL plaintiffs’ remaining theory was that the vaccine’s manufacturer violated state law by failing to warn medical providers about the alleged risk of POTS and POI. 

Federal law, however, quite strictly regulates vaccine labeling.  So the issue in the latest Gardasil opinion was one of implied conflict preemption of the impossibility variety:  Was it impossible for the manufacturer to comply with both the federal vaccine labeling requirements, and a state law duty to add warnings about POTS and POI?

Although impossibility preemption is a “demanding defense,” it isn’t as demanding as the plaintiffs suggested.  The MDL plaintiffs wanted the manufacturer to establish “clear evidence” that it was entitled to preemption (relying on language from Wyeth v. Levine, 555 U.S. 555 (2009)).  But the MDL judge recognized that Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019) had clarified (we’d say superseded, or maybe abrogated) that Levine language.  Post-Albrecht, Levine’s “clear evidence” language is “not to be interpreted as an evidentiary standard.”  In re Gardasil Prods. Liab. Litig., 2025 U.S. Dist. LEXIS 44376, at *36 n. 7.  It’s more of a “rhetorical flourish”. 

Moreover, because preemption is a question of law, the MDL court recognized that it, not a jury, had to decide the preemption issue—and that doing so before trial served the interests of the litigants and judicial economy.   Id. at 29 (citing Albrecht, 587 U.S. at 303).

Framing the exact inquiry, plaintiffs’ claims would be preempted if it was impossible for the manufacturer to comply with both federal and state law, either because the manufacturer:

(1) “did not have the authority to make changes to the label” that the plaintiff demanded; or

(2) established “that the FDA would not have approved the changes to the label that the plaintiffs contend should have been made.”

Id. at *36-37.

Starting with the first question, the court asked whether the manufacturer

was permitted under federal law to add [the plaintiffs’ proposed] warnings to the vaccine’s label without prior approval from the Food and Drug Administration (“FDA”) (which is typically required for any changes to a vaccine’s prescribing information).

Id. at *27. 

The answer was no, of course not.  As with new drugs, the FDA controls the warning labels on biologics like vaccines, and it is not a question of “more is better” when it comes to warnings. 

In formulating a vaccine’s label, FDA regulations seek to provide what may be best described as the “Goldilocks” amount of information; that is, ‘just right’ – not too little and not too much.  In addition to seeking to include all necessary information, the FDA tries to ‘prevent overwarning, which may deter appropriate use of medical products, or overshadow more important warnings.” 

Id. at *37-38. 

As to the “changes being effected” (“CBE”) exception to prior FDA approval, federal law (21 C.F.R § 601.12(f)(2)(i)) potentially does allow a manufacturer to change its warnings, but only in very limited circumstances:  If the manufacturer receives sufficient “newly acquired information” not previously submitted to the FDA, and the proposed change is based on “reasonable evidence,” it can roll out the new warnings as it seeks approval.  But again, the information has to be new, and there has to be reasonable evidence—evidence “on the basis of which experts qualified by scientific training and experience can reasonably conclude that the hazard is associated with the use of the drug.”  See 44 Fed. Reg. 2848, 2851 (allowing a CBE amendment only for “known hazards and not theoretical possibility”).

Relying on the CBE regulation, the MDL plaintiffs contended the Gardasil manufacturer should have unilaterally added warnings about POTS by 2011 and POI by 2013.  The burden thus fell to plaintiffs to identify the “newly acquired information” that supposedly would have allowed these unilateral label changes.  In re Gardasil Prods. Liab. Litig., 2025 U.S. Dist. LEXIS 44376, at *41.

Yet, as the Court noted, the evidence back then just did not support a causal connection, and was already known to the FDA anyway:

[By 2013], there had been only one published, verified case of POTS and four published case reports of POI. (In addition, there were scattered unverified reports of the illnesses, still totaling only a relatively miniscule handful). To the extent there were any broader studies or analyses before the relevant dates, they did not establish causal associations. Simply put, no scientist could reasonably conclude there is a causal association between POTS and POI and Gardasil based on this paucity of evidence, even putting aside the fact that the FDA was made aware of all these cases and studies (which raises a question whether they can even qualify as “newly acquired information”).

Id. at *28.

Having resolved the impossibility preemption issue by concluding that the Gardasil manufacturer could not do what plaintiffs said that state law required, plaintiffs’ claims were preempted. 

Sensing what was coming, plaintiffs had tried a few dodges.

During oral argument and in supplemental briefing, they argued that if POTS and POI warnings weren’t required in 2011 or 2013, the court could find they were required on some other date over the following decade or so, based on a rough “totality of the evidence” standard.  The MDL judge was having none of it (in judge-speak, it “declined this invitation to error”).

It is plainly impractical for the Court to separately rule on preemption for each day, month or even year between 2011 and January 2021 (the date of the last vaccination of a Bellwether Plaintiff). In fact, it is at least theoretically possible that [a manufacturer] could have had reasonable evidence of a causal association based on the “totality of the record” on a given date and then later not have such evidence if the record evolved in favor of [its] position.

Id. at *57.

The MDL judge also had a few thoughts about whether the FDA would have rejected “the changes to the label that the plaintiffs contend should have been made” if it had been asked:

[T]here is substantial evidence that the FDA does not agree with Plaintiffs’ allegations that there is a causal association between taking Gardasil and becoming sick with POTS and POI. The FDA has approved numerous Gardasil labels without any POTS or POI warnings from 2006 to the present; the department of Health and Human Services (“HHS”) (FDA’s parent agency) has consistently opposed allegations of a causal connection in the “Vaccine Court”; and HHS / FDA has publicly stated its view that Gardasil does not cause POTS or POI in general communications and the federal register.

Id. at *28 n. 2. 

The court’s discussion of the scientific evidence about whether Gardasil can cause POTS or POI is a good read.  While a few pages shorter, it is reminiscent of the In re Zantac MDL judge’s dismantling of the scientific evidence in that litigation.  A few notable nuggets: 

  • Temporal coincidence is insufficient for causation. 
  • Isolated case reports are insufficient for causation. 
  • Where the total number of possible adverse events in the time period is less than the overall background occurrence of the condition, the evidence is insufficient for causation. 
  • The FDA’s supposed lack of resources does not allow plaintiffs to ignore FDA standards. 
  • Supposed evidence about one issue (“autoimmunity”) does not help prove causation for a different issue (POTS).
  • Experts who rely on a handful of adverse events will be called out when they turn around and nitpick powerful studies involving thousands of patients as being “too small”. 
  • Preemption does not allow paid litigation experts to opine, well after the fact, that the FDA got the warnings wrong. 

At this point, there should not be much, if anything, of the Gardasil MDL left—and we just may have a good candidate for our “best of” list at the end of 2025. 

Photo of Bexis

As anyone who has read more than a paragraph of what we’ve written knows, this is a forthrightly pro-defense Blog.  It is not our practice to criticize the strategy or tactics of defendants or their counsel.  It’s not that what defendants do is always right, but to us its almost always understandable.

We were all set to make an exception to this rule, however, due to our disappointment in several decisions recently handed down in a Filshie Clip case in Texas:  Those decisions are:  Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 35222 (Mag. S.D. Tex. Feb. 27, 2025) (“Bulox I”); Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 34275 (Mag. S.D. Tex. Feb. 26, 2025) (“Bulox II”); and Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 34274 (Mag. S.D. Tex. Feb. 26, 2025) (“Bulox III”).  It’s not that the results were bad – the Bulox defendants won all three motions – but the reasoning is atrocious.  The Magistrate Judge completely ignored the 2023 amendment to Fed. R. Evid. 702 in denying the plaintiffs’ motions in these three orders.

Instead we were treated to statements such as:

  • “[A]s a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility.”  Bulox I, 2025 U.S. Dist. Lexis 35222, at *5 (quoting pre-amendments decision); Bulox II, 2025 U.S. Dist. Lexis 34275, at *5 (same);  Bulox III, 2025 U.S. Dist. Lexis 34274, at *4-5 (same).

That “bases and sources” merely go to the “weight” under Rule 702 is one of the “incorrect” statements that the 2023 amendments were enacted to stop.  That is a quote originating in a pre-Daubert case, Viterbo v. Dow Chemical Co., 826 F.2d 420, 422 (5th Cir. 1987) – one that the 2023 amendments to Rule 702 consider “incorrect.”  For further discussion of this, and other, points we make in this post, see our prior blogposts, here, here, and here, as well as M. Behrens & A. Trask, “Federal Rule of Evidence 702: A History & Guide to the 2023 Amendments Governing Expert Evidence,” 12 Texas A&M L. Rev. 43 (2024); and E. Lasker & J. Leader, “New Federal Rule of Evidence Rule 702:  A Circuit-by-Circuit Guide to Overruled ‘Wayward Caselaw,’” Def. Counsel J. (Summer 2024) (particularly the Fifth Circuit section). 

  • “While the district court must act as a gatekeeper to exclude all irrelevant and unreliable expert testimony, ‘the rejection of expert testimony is the exception rather than the rule.’”  Bulox I, 2025 U.S. Dist. Lexis 35222, at *5 (quoting pre-amendments decision); Bulox II, 2025 U.S. Dist. Lexis 34275, at *5-6 (same); Bulox III, 2025 U.S. Dist. Lexis 34274, at *5 (same).

That is another canard that the 2023 amendments were specifically intended to reject.  The “rule” is that the proponent of expert testimony must prove all elements of admissibility by a preponderance of the evidence.  If not, then the testimony is inadmissible; if so, then it can be heard.  One is not an exception to the other – they are two sides of the same coin.

  • “Furthermore, ‘[a]s a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility and should be left for the jury’s consideration.”’  Bulox I, 2025 U.S. Dist. Lexis 35222, at *11 (quoting pre-amendments decisions); Bulox II, 2025 U.S. Dist. Lexis 34275, at *11-12 (same).

There it is again.  The same outdated and incorrect statement from Viterbo, recycled through a different set of pre-amendments caselaw.

  • Movants’ “arguments largely relate to the bases of [the expert’s] review decisions, not the underlying methodology, and are therefore more suitable for cross examination.  Bulox I, 2025 U.S. Dist. Lexis 35222, at *11 (citations omitted); Bulox III, 2025 U.S. Dist. Lexis 34274, at *11.

This statement effectively reads recently amended Fed. R. Evid. 702(d) out of the Rule altogether.  The reliability of a would-be expert’s “principles and methods” is addressed by Rule 702(c).  That portion of the Rule was not amended.  Rule 702(d), however, was amended to clarify that the gatekeeping function (and the burden of proof) extend to “the expert’s opinion reflect[ing] a reliable application of the principles and methods to the facts of the case” (emphasis added).  So, no – putative experts do not get a free pass on applying “underlying methodology” to case-specific facts.  That statement is brazenly bogus.

  • Movants’ “arguments regarding [the expert’s] document review in reaching his opinion go to the bases and sources of his opinion and therefore, impact the weight, not the admissibility of his testimony. . . .  If these bases and sources are incorrect or incomplete, then Plaintiffs can effectively address those issues on cross-examination.  Bulox II, 2025 U.S. Dist. Lexis 34275, at *12.

That is the same erroneous Viterboesque statement using slightly different phrasing.  “Bases and sources” is just another way of saying “the facts of the case.”  This is yet another way that the Bulox trilogy simply ignores Rule 702(d), which was the one element of the Rule that the 2023 amendments specifically strengthened.

So here we were with three decisions denying all the Bulox plaintiffs’ largely perfunctory Rule 702 challenges to the three defense experts (yay!); but doing so by unnecessarily relying on anachronistic precedent contrary to the 2023 amendments to the Rule (boo, hiss!).  We were all set to write a rare blogpost criticizing defense counsel for jeopardizing the amendments merely to win denial of some motions that were poorly supported in the first place.  See Bulox II, 2025 U.S. Dist. Lexis 34275, at *7-8; Bulox III, 2025 U.S. Dist. Lexis 34274, at *9 (both finding waiver by reason of “inadequate briefing”).

But before we did such a thing, we wanted to be sure.  We have a PACER account and we know how to use it.  So we checked the defense opposition to the three motions in Bulox.  Those were the documents located at docket numbers 142, 144, and 145.  It turns out that the defense briefing in Bulox did not contain any of the incorrect statements about post-amendments Rule 702, nor did it cite to any of the anachronistic decisions cited in the three opinions.  Neither, however, did they emphasize the 2023 amendments and the changes they made.  Thus, it turns out that, while we remain appalled by terrible way that these three decisions reached correct results, we simply cannot blame it on either the defendants or their counsel.  They did not include any improper citations or make any penny-wise-but-pound-foolish arguments in their brief.

Instead, we blame a judicial system that places a low priority on updating outmoded template orders such as the Rule 702 forms that are obviously still being used in that chambers.  But be forewarned − if we do find instances of defense counsel making bad Rule 702 law by relying on bad pre-2023-amendments precedents, we will let you know.  Yes, it is that important.  Remember – “Don’t Say Daubert.”

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Certainly not us.  We had never heard of the UJNFLA before today and would likely have thought it was a reference to United Joggers of Northern Florida as much as to a Uniform Act promulgated in 1936 which, based on some quick research, was adopted by at least twenty-eight states, including Indiana where it is still on the books.  The status of the UJNFLA in the other twenty-seven states would need to be the subject of further investigation.  For example, we learned that in New Jersey it was once codified at N.J.S.A. § 2A:82-33 et seq., but was superseded by N.J. Rule of Evidence 201(a), which does not contain all of the same provisions.  Notably missing from that rule of evidence but present in the UJNFLA is a requirement that before any party can offer evidence of another state’s laws or ask for judicial notice of same, “reasonable notice shall be given to the adverse parties, either in the pleadings or otherwise.”  Ind. Code § 34-38-4-4.  What does that mean?  In Indiana it means that if a plaintiff, for example, wants to try to avoid that state’s statute of repose by arguing his home state’s law should apply – he better make that argument before summary judgment briefing. So said the Indiana Court of Appeals in Shaling v. Biomet, Inc., 2025 Ind. App. LEXIS 68 (Mar. 11, 2025).

Plaintiff, a resident of Alabama, underwent hip replacement surgery in 2001 with a medical device manufactured by defendant, a resident of Indiana.  Approximately fourteen years later, in early 2015, testing revealed elevated metal ion levels in plaintiff’s blood.  After additional testing, the metal hip implant was explanted in 2017.  Plaintiff filed suit in Indiana in 2019—eighteen years after the device was implanted.  The case progressed and was set for trial in June 2024.  In October 2023, defendant moved for summary judgment arguing that plaintiff’s claims were barred by Indiana’s ten-year statute of repose.  In opposition, plaintiff argued for the first time that the court should apply Alabama law which does not have an applicable statute of repose.  The trial court, relying on the UJNFLA, concluded that plaintiff failed to provide sufficient notice of his request to apply Alabama law and granted defendant summary judgment.

On appeal, the trial court’s application of the UJNFLA was reviewed for an abuse of discretion.  The Indiana Supreme Court has previously held that the “purpose of the notice requirement is to allow the other party time to prepare by studying the applicable law.”  Sword v. NKC Hospitals, Inc., 714 N.E.2d 142, 147 (Ind. 1999).  In that case, like in Shaling, plaintiffs waited until summary judgment to argue that Kentucky law should apply and claimed that reasonable notice was given because a sister action was pending in Kentucky state court.  The Indiana Supreme Court rejected that argument, finding that just because an injury occurred in another state is not “reasonable notice that a party will seek to use the other state’s laws.  Id. at 146.  Further, raising the issue at the summary judgment stage was not reasonable because “plaintiffs asserted a potentially strategy-altering issues without allowing [the defense] any opportunity to prepare.”  Id. at 147. 

Shaling is the same.  Plaintiff did not raise his choice of Alabama law until four years after the complaint had been filed, after defendant filed its summary judgement motion, and six months before trial—all after defendant had conducted discovery and developed its trial strategy based on Indiana law.  The appellate court found no abuse of discretion in the trial court’s application of the UJNFLA.

Since plaintiff was stuck with Indiana law, he tried to argue that he should be exempt from the statute of repose because his injuries are the result of a “protracted exposure to an inherently dangerous foreign substance” – like asbestos.  Shaling, 2025 Ind. App. LEXIS 68, at *12.  But the Indiana Product Liability Act is clear, a product liability action must be commenced with ten years after the delivery of the product to the consumer. I.C. § 34-20-3-1.  There is only one judicially created exception—for allegations of latent harm from asbestos exposure.  But there is no case law to support plaintiff’s theory that Indiana has adopted a “general latent disease exception.”  Id. at *15.  Any such exception has to be enacted by the legislature, not the courts.  Plaintiff’s claims, filed eighteen years after the device was implanted, were barred by the stature of repose.  Summary judgment was affirmed.

Wonder what we’ll learn tomorrow?   

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