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Bexis was a mere college freshman, and a Princeton football manager, on September 28, 1974.  In the first game of the season, Rutgers played Princeton at Princeton’s old (and rather decrepit) Palmer Stadium.  With about three minutes to go and Rutgers up 6-0, Rutgers fans swarmed the field and tore down both sets of goalposts.  When Princeton tied the game up with less than half a minute left, without goalposts we could not kick an extra point.  A two point conversion failed, and Rutgers escaped with a tie.

Not quite half a century later, Rutgers scored an actual win.  This time Bexis is pleased.  In Children’s Health Defense, Inc. v. Rutgers, the State University of New Jersey, ___ F.4th ___, 2024 WL 637353 (3d Cir. Feb. 15, 2024) (“CHD”), the Third Circuit affirmed the right of a publicly supported university to require COVID-19 vaccination as a prerequisite to its students’ in-person attendance.  We blogged about this outcome in the district court, and its precedential affirmance is even more significant.

Continue Reading Tear Down the Goalposts – Rutgers Wins
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The MDL and state court proceedings involving saxagliptin-based diabetes drugs (such as Onglyza and Kombiglyze) strike us as the mass tort that never should have been.  These proceedings initially followed a familiar model—a publication identified a signal of a risk (albeit an exceptionally weak signal), and plaintiffs’ lawyers took their cue to collect their inventories in the usual ways and file lawsuits.  Those lawsuits, however, have largely crashed and burned in both state and federal court, and for the same reason.  The plaintiffs were unable to find competent expert opinion that saxagliptin is capable of causing heart failure.  We gave you our take on the MDL judge’s order excluding the plaintiff’s expert here, and the California appellate opinion affirming a similar order came in as our fifth best drug/device case of 2023

The Sixth Circuit has now joined the chorus.  In In re Onglyza & Kombiglyze Products Liability Litigation, No. 22-6078, 2024 WL 577372 (6th Cir. Feb. 13, 2024) (to be published in F.4th), the Sixth Circuit held that the MDL judge correctly excluded the plaintiff’s general causation expert and granted summary judgment, and it also upheld the district judge’s refusal to allow the plaintiffs a second chance. 

To recap, the plaintiffs in Onglyza alleged that the medication caused heart failure and related cardiac conditions.  The FDA had asked the manufacturers to conduct a randomized controlled trial with multiple cardiac endpoints, which they did.  The result was that there were no statistically significant differences between the drug and placebo for any primary endpoint, which included cardiac death, heart attack, and ischemic stroke.  The same was true for secondary endpoints—except for one:  Hospitalization due to heart failure.  The study authors noted that the heart failure finding was unexpected and that it should be considered within the context of multiple tests that may have resulted in false positive results.  The authors also cautioned that “a class effect should not be presumed.”  Id. at *1-*2. 

That is the scientific backdrop against which the plaintiffs offered a single general causation expert, whose opinions were ultimately inadmissible for three reasons.  First, the expert relied on a single study (and an inconclusive one at that), to the exclusion of all other studies involving human data.  Four later observational studies found no association, and even the plaintiffs’ expert agreed that the studies were “reasonably designed.”  He nonetheless ignored them, purportedly because of “issues related to confounding,” but he identified no specific issues or confounders in any of the studies.  As for the one study, it was “no smoking gun.”  It observed only a higher incidence of hospitalization in patients treated with saxagliptin, not a causal link.  And the study authors stated that there “are presently no known mechanisms” by which the drug could cause heart failure.  Id. at *4.  The plaintiffs complained that the district court had imposed a “one unreplicated study is not enough” standard, but that was not true.  The district court properly concluded that the expert acted unreliably by relying on the one study while ignoring all other human studies.  Id.

Second, without human data to support his opinions, the expert attempted to rely on animal data instead.  He had, however, no expertise in interpreting animal studies, and he conceded that he was unqualified to conclude that the animals in the studies “actually had heart failure.”  Indeed, multiple animal studies actually dispelled a causal link between saxagliptin and heart failure, which the expert admitted.  Id. at *5.

Third, the expert did not reliably apply the Bradford Hill criteria.  Experts often fall back on the Bradford Hill criteria to bolster their causation opinions.  But here, there were multiple grounds to find that the plaintiffs’ expert got it wrong.  He cherry-picked data.  He drew an “analogy” to a different diabetes medication, but could not explain why, other than to assert that it was “appropriate” because the other medication had “been shown to ‘worsen heart failure.’”  Id. at *5.  A more blatant admission of result-oriented data selection is hard to imagine.

The expert also  applied other factors inconsistently—for example, by claiming in his report that two factors (specificity and biological gradient) were satisfied, but later testifying that they were not.  Id. at *5-*6.  Plaintiffs’ response to this was predictable:  Leave it to the jury to “evaluate and weigh” the testimony.  But that solution applies only to the evaluation of admissible evidence, and “district courts may allow juries to evaluate and weigh only relevant and reliable expert testimony.”  Id.  The decision underscored these points by repeatedly relying on the “amended” language of Rule 702 requiring proof that an expert’s methodology is “reliably applied” to the facts of the case.  Id. at *3, *5, *6 n.7.

Without admissible expert opinions on general causation, the Sixth Circuit affirmed summary judgment, too.  To avoid this result, the plaintiffs first tried to argue that expert causation opinion was not necessary for them to prove their case.  We have not studied the evidence, but we are guessing the plaintiffs were offering to prove their case with internal company documents, regulatory documents, adverse event reports, and the like.  The Sixth Circuit, however, rejected that approach.  The district court reviewed the law of all fifty states and determined that every state requires “the plaintiff in cases involving complex issues of medical causation to present expert testimony.”  Id. at *6.  The plaintiffs could not cite a single case actually holding otherwise.  Id. at *7.  We’ve discussed district court opinions reaching this 50-state conclusion, but we believe Onglyza is the first appellate court to so rule.

The plaintiffs also wanted a second chance to find another expert, but the district court declined, and so did the Sixth Circuit.  Although they characterized their request as an “extension,” they were really asking for a complete do-over of expert discovery, and it was well within the district court’s discretion to say no.  The plaintiffs could not explain why they failed to identify other, reliable experts despite “years of expert discovery.”  Id.  Further, their argument that the “minimal delay” would cause “no prejudice” to defendants was not credible.  The plaintiffs wanted to “essentially restart expert discovery, requiring depositions, briefing, hearings, and motions on plaintiffs’ new expert.”  Id. at *8.  To put a finer point on it, “[t]his would delay the MDL’s resolution by for years—just consider that plaintiffs requested three months to simply identify an expert.”  Id.  The substantial legal expenses and years of delay would most certainly cause prejudice to the defendants. 

We particularly like this last ruling.  Allowing plaintiffs to disclose one expert, then try again if that expert did not work out, would drag out litigation seemingly forever.  As the Sixth Circuit held, “The [district] court properly refused to reward plaintiffs for their failure to identify a reliable general causation expert by imposing significant costs on defendants”  Id. at *8.  We hope the judge in the Acetaminophen MDL is listening. 

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For many years, even before the Supreme Court picked up the ball, we have been arguing that “stop selling” theories of liability for alleged injuries from prescription drugs should not be viable.  This is not just a preemption issue.  Basic product liability principles do not square easily with liability contingent on developing one drug instead of another or no other.  See here and here for two of many posts.  Over the same general time period, we have been similarly put off by the idea that a company that develops a drug that the plaintiff valued so much that she brought a suit to keep taking could be subject to liability (or equitable relief) if it stopped selling/providing the drug.  This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007) (en banc), and CareToLive v. von Eschenbach, 525 F. Supp.2d 952 (S.D. Ohio 2007), but has generally failed to expand that foothold since.  In particular, plaintiffs trying to force clinical trial sponsors to continue providing free drug after the end of the trial—something clinical trial participants are told is not a guaranty—have floundered.

Instead of highlighting the cognitive dissonance of the possibility that both of these theories of liability could be viable, we could be touting the creativity of the plaintiff lawyers trying different approaches to force pharmaceutical companies to play an unfun version of Simon Says.  (Don’t get us started on the ridiculous decisions involving tenofovir and the supposed duty to innovate.)  The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view.  We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

This is not the first time we have written about litigation related to this shortage.  Back in 2015, the District of Massachusetts determined that there was no duty to keep supplying a drug that a company marketed, at least under the law of the twenty-two states where the plaintiffs resided and with a healthy appreciation of Erie restraint.  Presumably to help patients taking the drug, the manufacturer took measures to minimize the impact of the Fabrazyme shortage occasioned by contamination at its production facility.  It could have just let market forces do their thing with the drug that had been made already or even discontinued the drug entirely, but its efforts to keep some of the drug on the market for on-going use while it worked to bring full manufacturing back on-line were met with lawsuits.  Only one of the plaintiffs claimed that use of a reduced dosage of the drug had somehow “sensitized” him to a worsening of his Fabry’s disease.  On appeal, the First Circuit found that the “sensitization” plaintiff had pleaded an injury in fact, giving him standing, but all the others lacked standing to complain about how much of the drug was available to them.    Even though the focus on appeal had switched from duty to standing, the First Circuit’s Hochendoner decision drew honorable mention honors for the year.  For some reason, with its win on almost all the claims in hand, the manufacturer still engaged in settlement discussions with plaintiffs and potential plaintiffs.

About five years later—more than nine after the shortage ended—a number of the prior plaintiffs and potential plaintiffs were back in the District of Massachusetts with revamped claims over the same old general facts.  The claims were all dismissed, most without prejudice based on lack of standing under Hochendoner and four (who had standing) with prejudice on statute of limitations.   The plaintiffs appealed, but the defendant did not appeal the denial of its statute of limitations challenges as to the plaintiffs without standing.  If that history was not confusing enough, the First Circuit affirmed the statute cases and reversed on the standing cases, but provided a roadmap for the district court to get rid of all of them on statute after remand.  Wilkins v. Genzyme Corp., — F.4th –, 2024 WL 636990 (1st Cir. Feb. 15, 2024), does not have our preferred result, but it is worth discussing.  Clearly, for the overall state of the law in this area, a finding of no duty/claim is best, followed by no standing, with statute of limitations in third.  Wilkins did not address whether the plaintiffs’ claims as pleaded were viable under their respective states’ substantive law, only whether an injury in fact had been pleaded.  This is a fairly technical distinction, but nothing compared to the technical and fact-specific nature of the statute of limitations analysis.

Of interest to us is how some of the Wilkins plaintiffs changed their story over time to get around the standing ruling in Hochendoner.  It is of some solace that this change doomed some of them on statute, but the gamesmanship should not have worked on standing either.  We will explain as briefly as we can.  The standards for pleading an injury in fact for the purposes of standing are spelled out in a number of our recent posts, including the one on the district court decision in this case.  Whereas one of the plaintiffs in Hochendoner had claimed “sensitization” as a mechanism for injury, now all the plaintiffs made the same claim.  The First Circuit credited the convenient “specific allegations about the particular injuries suffered by each plaintiff,” rejecting the district court’s analysis that these conclusory allegations failed to distinguish what allegedly happened to them from typical disease progression.  2024 WL 636990, *4-5.  Twenty one of the plaintiffs added the claim that they had actually received contaminated drug, which hurt them.  This is really a manufacturing defect claim, not a claim based on an alleged duty to continue providing a drug, so it probably does support standing; it just almost never ends up having support beyond general allegations that should not pass TwIqbal.  The court also agreed that economic claims based on “paying for ineffective and medically worthless doses of Fabrazyme” conferred standing.  Id. at *5.  We agree with the court’s implication that the defendant will have strong defenses on the merits that do not go to standing as long as plaintiffs pled that they paid for the drugs they took.  However, there would be no claim had the manufacturer pulled the drug from the market, something that these same plaintiffs would have sued to stop.

For the four plaintiffs dismissed on statute below, to have their claims considered timely required filling a gap from cases originally filed in 2011 and 2013 to a case filed in 2021.  First, the plaintiffs who filed in 2013 tried to rely on class action tolling under American Pipe, which we have said before does not work well with product liability claims.  One of the cases dismissed in Hochendoner had a class allegation that might have covered these plaintiffs.  Unfortunately for them, Indiana law governed statute and Indiana does not recognize class action tolling.  Id. at *8.  Moreover, the plaintiffs whose original claims were filed in 2011, and thus timely back then, tried to rely on Indiana’s three-year savings clause.  There were a number of problems with this argument, the most ironic of which is that the original case did not allege individual injuries and sensitization.  Those allegations in the new case were key to standing, but their absence in the original case meant that the plaintiffs were essentially asserting new claims not trying to continue the ones dismissed without prejudice back in 2016.  Id. at *9.  There is some more to the statute analysis, but we will stop here.  The plaintiffs should have stopped long ago.  Trying to convert a claim without standing because of no injury in fact into a viable claim years later based not on a new injury, but on a new approach to pleading, should not work.

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Our abiding skepticism about multidistrict litigations (MDLs) is redeemed — a little — by the recent decision in In re CPAP, 2024 U.S. Dist. LEXIS 25528 (W.D.Pa. Feb. 14, 2024). The Lexis printout of the opinion is not nearly as long as it looks. More than half the pages merely list the attorneys.  Lots and lots of attorneys. 

The opinion we are discussing today was authored by the MDL district judge, reviewing the CPAP medical monitoring rulings of a special master. We previously analyzed the special master’s rulings  here.  In case you do not remember, we concluded that many of the special master rulings made sense. After all, the special master recommended that the defendant’s motion to dismiss be granted with respect to tort claims under the laws of 30 states that adhere to the traditional “manifest physical injury” rule. But the special master would have permitted many iffy claims, thereby violating the notion of Erie conservatism — i.e., that federal courts should not cavalierly predict that a state court would expand liability. We thought that parts of the special master’s rulings seemed overly ambitious or wrong or at least unclear. The district court thought so, too, as it issued instructions to the special master to try again. In a sense, the district court gave the special master (a retired Third Circuit judge) homework. 

The CPAP MDL is made up of claims against CPAP machines.  There were three forms of the dreaded master complaints: a personal injury master complaint, an economic loss master complaint, and a medical monitoring master complaint.  It is that last version, medical monitoring, that is at issue here. The medical monitoring complaint includes 69 plaintiffs who purported to represent a nationwide class of people seeking medical monitoring. The medical monitoring complaint did not allege “a manifest physical injury.”  The plaintiffs alleged that they had ingested foam toxins from the CPAPs and that such toxins were absorbed into their blood streams. Certain of the toxins were alleged to be carcinogenic and the prediction was that serious injuries would inevitably follow.  The court tells us that “Plaintiffs’ counsel explained there will be no medical records diagnosing a subcellular injury but there will be expert testimony.”  Right. We bet there will.  

The district court prefaced its analysis by observing that medical monitoring “is a controversial concept that has not undergone widespread scrutiny in the state courts, let alone gained widespread acceptance.”  We’ll be rather less polite. We think medical monitoring claims are dangerous bunk. Some courts think so, too. Some don’t. Some aren’t sure. The states are split in many ways over medical monitoring. Some states treat medical monitoring as its own claim. Where medical monitoring is not a stand-alone claim, its availability depends on establishment of the elements of another tort.  It is a mess. The various judicial splits over medical monitoring are detailed in these posts.

The district court judge provides an excellent discussion of the binding Third Circuit precedent (which led off our prior post) that precludes courts sitting in diversity jurisdiction from expanding state law.  A mere unsupported pronouncement by a federal court about what a state’s law should be ought not alone be sufficient to serve as the requisite clear indication of state law.  Nor does a complete absence of authority support expansion of state law. The district court, thankfully, rejected the plaintiffs’ argument that in five states without relevant caselaw the court should “err on the side of liberal pleading.”  

The district court ordered the special master’s broad holdings that certain state statutes support medical monitoring (criticized in our prior post) must be re-evaluated because the special master failed to analyze each state’s law.  To be sure, the parties did not provide the special master with a state-by-state roadmap, which seems darned inconsiderate and darned silly. Medical monitoring claims must be analyzed under the laws for each state. Accordingly, the district court remanded to the state court to do better. 

The district court did not disturb the special master’s determination that the declaratory judgment claim was plausibly pleaded, at least pending factual development of the medical monitoring claims in those jurisdictions that tolerate such nonsense.  

No state-specific disputes about medical monitoring are resolved by the district court due to the special master’s recommendation being unclear and at some points complicated by “inadvertent” errors. The bottom line is that the special master’s report and recommendations were not adopted, and the special master and the parties have some work to do. File this under To Be Continued. But it is always gratifying to see an MDL court insist on rigorous examination of the legal claims.  

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This post is not from the Reed Smith or Holland & Knight sides of the blog. 

Sometimes the intersection of the law and the facts are simply undeniable. Such was true of the fourth bellwether case selected in the Bard hernia mesh MDL–Bryan v. C.R. Bard, Inc., 2024 WL 385108 (S.D. Ohio Feb. 1, 2024). It was undeniable that the implanting surgeon did not rely read any warning from the manufacturer or rely on any representation from the manufacturer. It was undeniable that Florida law embraces the learned intermediary doctrine. It was undeniable that Florida requires privity for breach of warranty claims. It was undeniable that Florida does not allow products liability claims for intentional infliction of emotional distress. So, it was undeniable that the court should grant summary judgment on all these claims.

In 2012, Plaintiff underwent laparoscopic surgery to repair an inguinal hernia that included implanting defendant’s hernia mesh product. The mesh remained in place until plaintiff underwent a partial explant in 2017, where the explanting surgeon noted “no obvious signs of an abnormality.”  Id. at *3. Plaintiff alleges he continued to suffer pain and so filed suit seeking damages based on a myriad of causes of action. The court deferred ruling on certain claims, but on those it did entertain it granted summary judgment.

On failure to warn, the court determined it did not have to decide the adequacy of the warning because plaintiff failed to establish warning causation which required plaintiff show that his physician would have chosen not to use the product if he had received different warnings. Here, plaintiff’s implanting surgeon testified he did not rely on the product’s Instructions for Use (IFU) in deciding to use the mesh. In fact, he had never even seen it. Id. at *6. While plaintiff tried to rely on out of state cases to suggest that failure to review the IFU was not dispositive, the court deferred to the numerous Florida federal courts that ruled just the opposite. Id. Nor did the court find persuasive cases in which other courts left open the possibility that the treating physician may have at some time reviewed the IFU because here the surgeon’s testimony left no room for doubt.  He’d never read the IFU; never seen it.  He didn’t rely on it and if it contained different information, it would have made no difference to him.  Id. at *7. 

Plaintiff’s negligent and fraudulent misrepresentation claims suffered from a similar fatal deficiency.  Florida law requires not only a misrepresentation, but reliance on the misrepresentation resulting in injury.  Once again, plaintiff’s implanting surgeon was clear.  Not only did he not rely on the IFU, he did not rely on anything said to him by defendant’s sales representatives.  His decision to use defendant’s mesh was “absolutely” his own clinical judgment. Id. at *8. Sales representatives have “zero influence” in his clinical decisions. Id.

To bring a breach of warranty claim under Florida law, the plaintiff must be in privity of contract with the defendant. Id. at *9. Plaintiff, relying on one federal case from 2021, tried to argue that as the third-party beneficiary of defendant’s warranties, he had a valid claim. The court quickly pointed out that plaintiff’s lone precedent was an outlier and that the majority of Florida federal courts since have ruled differently.  Absent privity, plaintiff could not maintain his warranty claims.

Finally, plaintiff tried to argue that defendant’s failure to warn of known risks was so “extreme and outrageous” to justify a claim for intentional infliction of emotional distress. Not only did plaintiff have no case law to support his failure to warn turned intentional infliction claim, but the court also found plaintiff offered no evidence that defendant’s conduct rose to the level of outrageousness required by Florida law.  The court did not address that the product was cleared by the FDA, but that fact alone should defeat the extreme mental state required of defendants in intentional infliction of emotional distress cases.

No reliance, no privity, and no outrageous conduct—a trifecta we’ll laud any day.

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This post is only from the non-Butler Snow part of the Blog.

As our 50-state survey of the learned intermediary rule demonstrates, the rule now applies in all fifty states.  That includes statutes or high court decisions from 38 states and the District of Columbia, intermediate state appellate decisions from four more states, and federal appellate Erie predictions from seven more states and Puerto Rico.  All told, only three states lack binding appellate precedent approving of the learned intermediary rule:  Rhode Island, South Dakota, and Vermont.  All three of those states have federal district court precedent, and Rhode Island has unpublished federal appellate authority in addition.

Then there’s Oregon.  That state was an early adopter of the learned intermediary rule, see McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974), but a subsequent decision held that the Oregon product liability statute, which basically adopted Restatement §402A in toto, meant that the rule did not apply in strict liability cases, because §402A did not reference the rule.  Griffith v. Blatt, 51 P.3d 1256, 1262 (Or. 2002).

But in Oregon strict liability litigation, or anywhere else that some plaintiff argues that for some reason the rule doesn’t apply, there is a backup argument – implied preemption.

Continue Reading Preemption as a Backup for the Learned Intermediary Rule
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The Dearinger case in the Western District of Washington provided a lot of defense friendly blog fodder. It made its way to the Washington Supreme Court for a certified question whether Washington would recognize a direct to consumer exception to the learned intermediary rule. The Washington Supreme Court answered that question with a resounding no.  Following that decision, the district court dismissed some of plaintiffs’ claims on an initial motion for summary judgement.  We blogged about that decision here.  The latest decision in Dearinger v. Eli Lilly & Co., 2024 WL 416848 (W.D. Wash. Feb. 5, 2024) serves up some nice defense nuggets applying the Washington Product Liability Act (WPLA) and refusing to let a sham affidavit create a fact issue.

Continue Reading Last Nail in the Coffin for Dearinger
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Today’s guest post is by Sherry Knutson and Brenda Sweet of Tucker Ellis, and concerns the recently passed legislative repeal of a Michigan statute that, for several decades had effectively immunized prescription drugs from ordinary product liability actions under Michigan law. For background, here’s a prior blogpost that focused on the now-repealed statute. As our guest post describes, that is no more, and we will need to dust off our Michigan law books. Fortunately, our guest bloggers assure us, the repeal should not be retroactive. As always our guest bloggers deserve all the credit (and any blame) for their writings.


As the DDL blog has previously reported, Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. 410.  As both the blog and many of us defense practitioners can attest, the statute before repeal, Mich. Comp. Laws Ann. §600.2946, successfully barred plaintiffs from obtaining recovery (notably, in the Taxotere and PPI MDLs, which resulted in the mass dismissal of hundreds of plaintiffs in the past few years, see In re Taxotere (Docetaxel) Prods. Liab. Litig., 2021 WL 1285087 (E.D. La. Apr. 7, 2021) and Doc. 13327 (Oct. 12, 2021); In re Proton Pump Inhibitor Prods. Liab. Litig., 2022 WL 5265300 (D.N.J. Sept. 20, 2022) (dismissing 197 cases)) and discouraged countless others from being filed.

But as of February, 13 2024 – the effective date of the revisions – that is no longer the case.  The two of us recently wrote about the issue of retroactivity of Michigan S.B. 410 repeal in Law360 (i.e., whether it applies to plaintiffs who were allegedly injured before February 13 but file suit after), and the short answer is, it is not.  That is primarily because, pursuant to Michigan’s four LaFontaine factors (see LaFontaine Saline, Inc. v. Chrysler Grp., LLC, 852 N.W.2d 78, 85-86 (Mich. 2014)) for determining retroactivity, the recent repealer statute has no specific language stating it should be given retrospective application and the revised statute imposed a new duty (specifically, a new duty on manufacturers/sellers).  These two particular factors bear repeating here, as (going forward) does a quick primer on relevant Michigan products liability law.

Retroactivity:  Intent of the Legislature and Creation of a New Duty

The Michigan Supreme Court held that legislative intent is the “primary and overriding factor” to determine retroactivity.  Frank W. Lynch & Co. v. Flex Techs., Inc., 624 N.W.2d 180, 182 (Mich. 2001).  As to S.B. 410, there is not much “intent” to read into it, as the Michigan legislature indicated only that it was effective February 13, 2024.  Nothing about retroactivity.  Nothing about it applying to claims accruing on a certain date in the past.  Without more, the Michigan Supreme Court held in Johnson v. Pastoriza that such a statute “should be applied prospectively only.”  818 N.W.2d 279, 287 (Mich. 2012).  It’s also worth noting that Michigan state Senator Jim Irwin, who sponsored S.B. 410, admitted that he did not believe Michiganders could receive payouts retroactively

Additionally, if applied retroactively, the revisions would impose a new duty on pharmaceutical drug manufacturers and sellers at the time the injury occurred, where none had existed before.  This defies logic, fairness, and – unsurprisingly – due process.  In such cases where a new duty has been created, Michigan courts have recognized that “because plaintiff’s claim had already accrued on the day she was injured, the retroactive application [of the revised statute] would effectively rewrite history as to the duty defendant owed plaintiff . . . . This is precisely what the third [LaFontaine] factor disallows.” Buhl v. City of Oak Park, 968 N.W.2d 348, 354 (Mich. 2021).

Consistent with this disfavor of rewriting history as to the duty of the defendant after a cause of action accrued, Michigan courts focus on which law applied on the date of the injury, even if the complaint was filed after the effective date.  See Schilling v. City of Lincoln Park, No. 342448, 2019 WL 2146298, *9 (Mich. Ct. App. May 16, 2019) (declining to apply new law where cause of action accrued before effective date, but case filed after effective date).  Thus, drugmakers and sellers should anticipate that they will no longer be immune from suit relating to any injuries occurring on or after February 13, 2024.

Michigan Products Liability Law:

Because of §600.2946, many blog readers may not have encountered other aspects of Michigan product liability law.  Few counsel have had to defend a pharmaceutical products liability case in Michigan in the past 25-plus years, but the defense side is equipping ourselves to do so.  To help, here is a quick primer on the lay of the Michigan legal landscape.  It is apparent that defense advocacy in developing Michigan law on various concepts will be needed.

Strict Liability:  Michigan does not recognize a separate “strict liability” cause of action in product liability cases.  See Johnson v. Chrysler Corp., 254 N.W.2d 569, 571 (Mich. Ct. App. 1977); see also Klein by Klein v. Caterpillar Inc., 581 F. Supp. 3d 912, 922 (E.D. Mich. 2022) (recognizing the following product defect liability theories:  “(1) negligent design of the product; (2) negligent manufacture of the product; (3) negligent failure to warn about some aspect of the product; (4) breach of express or implied warranty; or (5) misrepresentation or fraud”).

Impact of FDA Approval:  While there is no blanket immunity after February 13, there remains a rebuttable presumption that the manufacturer or seller is not liable if the aspect of the product that allegedly caused the harm complied with relevant standards set forth in a federal or state statute or was approved by, or was in compliance with, regulations or standards relevant to the event promulgated by a federal or state agency responsible for reviewing the safety of the product.  See Mich. Comp. Laws Ann. §2946(4).  As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue.

Alternative Design:  To establish a design defect claim, a plaintiff must establish that “a practical and technically feasible alternative production practice was available that would have prevented the harm without significantly impairing the usefulness or desirability of the product to users and without creating equal or greater risk of harm to others.”  Mich. Comp. Laws Ann. §2946(2).

Learned Intermediary:  Decades-old authority supports the proposition that Michigan courts would apply the learned intermediary doctrine.  See Smith v. E.R. Squibb & Sons, Inc., 273 N.W.2d 476, 479 (Mich. 1979); Mowery v. Crittenton Hospital, 400 N.W.2d 633, 637 (Mich. App. 1986). 

Statute of Limitations:  Michigan’s statute of limitation is three years for product liability claims.  Mich. Comp. Laws Ann. §600.5805(2), (12).  Critically, there is no discovery rule, and the cause of action accrues when the wrong occurs.  Good v. Howmedica Osteonics Corp., No. 15-cv-10133, 2015 WL 8175256, at *3 (E.D. Mich. Dec. 8, 2015).

Statute of Repose:  There is no applicable statute of repose in Michigan; however, after a product “has been in use for not less than 10 years, the plaintiffs, in proving a prima facie case, must do so without the benefits of any presumption.”  Mich. Comp. Laws Ann. §600.5805 (12).  To which “presumptions” this statute applies is undefined, and case law on this issue is not well developed.  See Prasol v. Cattron-Theimeg, Inc., No. 09-cv-10248, 2010 WL 4982899, at *5-6 (E.D. Mich. Dec. 2, 2010).

Punitive Damages v. Exemplary Damages:  These are not interchangeable concepts under Michigan law.  Punitive damages, which are designed to punish a party for misconduct, are “generally not recoverable in Michigan” unless expressly authorized by statute.  Casey v. Auto Owners Ins. Co., 729 N.W. 2d 277, 286 (Mich. Ct. App. 2006).  Thus, they are not imposed as to products liability (Buhland v. Fed. Cartridge Co., No. 12-cv-244, 2013 WL 12085097, at *4 (W.D. Mich. May 9, 2013)) or wrongful death cases (White v. FCA US, LLC, 579 B.R. 804, 813 (E.D. Mich. 2017)).  Exemplary damages are designed to compensate plaintiffs for “humiliation, sense of outrage, and indignity resulting from injuries ‘maliciously, willfully and wantonly’ inflicted by the defendant.  Unibar Maintenance Servs., Inc. v. Saigh, 769 N.W.2d 911, 923-24 (Mich. Ct. App. 2009) (citations omitted).  Michigan courts have recognized that although “product-liability actions do not usually involve such circumstances,” exemplary damages are technically available (Buhland, 2013 WL 12085097, at *4) – but again, not in wrongful death cases (White, 579 B.R. at 813).

Damages Caps:  Non-economic damages are capped but subject to change every year based on inflation.  For 2024, they are capped at $569,000, unless the defect caused death or permanent loss of a vital bodily function, in which case non-economic damages are capped at $1,016,000..  See Mich. Comp. Laws Ann. §600.2946a(1).  These caps do not apply if the trier of fact determines the death or loss was the result of gross negligence (Mich. Comp. Laws Ann. §2946a(3), or if the court determines that at the time of manufacture or distribution the defendant willfully disregarded “actual knowledge” that the product was defective and that there was “a substantial likelihood that the defect would cause the injury.”  Mich. Comp. Laws Ann. §600.2949a. 

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Happy Valentine’s Day. To celebrate, we will discuss a court decision that we love.

Preemption and the Ohio Product Liability Act (OPLA) are two of the best friends a drug/device defense lawyer has.  Both show up in Groeschen v. Alcon Laboratories, Inc., 2024 Ohio Misc. LEXIS 2 (Ohio Ct. Comm. Pleas Feb. 2, 2024). As the Groeschen court explained, this case has a “lengthy history.”  In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss.  The plaintiff alleged that the lenses malfunctioned as the result of some unspecified defective manufacturing process or chemical contamination, and that the defendants failed to warn him of the potential injuries.  

The manufacturer moved to dismiss the complaint, and then the First Amended Complaint.  In 2021, the court granted that motion to dismiss, in part, with preemption being the basis for dismissal. The court also ordered a more definite statement with respect to the manufacturing defect claim. That more definite (except it really wasn’t – more on that later) statement arrived in the form of a Second Amended Complaint.  The manufacturer again moved to dismiss. Meanwhile, discovery took place. The defendants met their discovery obligations.  The plaintiff … not so much.  The manufacturer then moved for summary judgment. The grounds for the summary judgment motion were fairly straightforward: the plaintiff had no evidence.  After the court denied the plaintiff’s request foradditional time to conduct discovery, the  plaintiff voluntarily dismissed the Second Amended Complaint. The court never ruled on either the motion to dismiss the Second Amended Complaint or the motion for summary judgment. 

Thus concluded Groeschen I

Now we get to Groeschen II.  In 2023, the plaintiff refiled the case. There was a Complaint.  Then there was a First Amended Complaint.  If you’re keeping count throughout the life of this case in its various iterations, we are now up to the fifth pleading overall.  And yet the claims were essentially the same, including the claims (negligence, products liability, breach of implied warranty) that were previously held to be preempted.  

Have you heard the definition of insanity as doing the same thing and expecting a different result?

The manufacturer moved to dismiss the latest (but not greatest) complaint.  We’re guessing that it was easy enough to dust off the old motion to dismiss and summary judgment motion, change a few dates, and then file and serve. There is nothing insane about doing the same thing and expecting the same result. 

The contact lenses were a class III medical device, meaning that they had gone through the rigorous Pre Market Approval (PMA) process, and meaning that any legal claim attempting to impose “any requirement” that “is different from, or in addition to” and FDA requirement would be preempted.  There was no getting around the fact that the plaintiff’s claims insisted that the medical device at issue – the lenses— should have been manufactured, designed, or labeled differently from the manner approved by the FDA. 

Well, maybe there was one possible way of getting around preemption, and by now almost all of you can predict that the plaintiff resorted to the Riegel parallel claim exception.  (Has any SCOTUS dictum visited more mischief? Inspired more frivolity by hapless plaintiff lawyers?  Made necessary more indignant blogposts?) If the plaintiff could point to a violation of FDA regulations that parallels a state law violation, his claims could conceivably squeeze through the “narrow gap” and evade preemption. But such parallel claims require more than conclusory violation claims. This was the issue that prompted the Groeschen I court way back in 2021 to ask the plaintiff to author a more definite statement. But in multiple complaints, the plaintiff failed to plead any violation of any particular federal specification.  Nor did the plaintiff identify particular Ohio state-law duties that parallel any FDA requirement.  Inevitably ineluctably indubitably, the Groeschen II court pushed the trap door button: “Plaintiff’s inability to allege the elements of a parallel claim capable of surviving preemption after five complaints in two cases over six years requires dismissal of all of Plainitff’s claims against [the manufacturer] as preempted.”

The court almost sounds exasperated. 

Maybe it was. We say that because, after hammering the plaintiff on preemption grounds, the Groeschen court held that even if preemption did not apply, the plaintiff’s claims for negligence, breach of warranties, and “common law tort claims for breach of implied warranty/strict liability” were abrogated by the OPLA, which precludes separate common-law claims.  The claims that otherwise could proceed via the OPLA still fail, because they fail to specify any particular design, warning, or manufacturing defect.  Moreover, the OPLA precludes consumer fraud claims in product liability cases. Lastly, the OPLA (bless it) bars punitive damages against FDA-approved products. 

The plaintiff lost, and the court’s reliance on multiple grounds makes an appeal by the plaintiff all the more difficult. 

Groeschen is a good decision that was a long time coming. We are grateful to our esteemed colleagues and friends at Greenberg TraurigMarcella Ducca and Greg Ostfeld — for bringing this case to our attention, and even more grateful for their excellent efforts in earning such a fine result. 

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We offer today’s case as a good recitation of Alabama warranty and fraud law.  Both have precise pleading requirements that plaintiff failed to meet in Morris v. Angiodynamics, Inc., 2024WL 476884 (M.D. Ala. Feb. 7, 2024). 

Plaintiff was implanted with a port used to deliver his chemotherapy treatments.  About five months after implant, plaintiff developed a pulmonary embolism and deep vein thrombosis.  When the port was explanted it was found to be clotted.  Id. at *1.  Plaintiff brought claims for negligence, breach of warranty, and fraud against the manufacturer; and defendant moved to dismiss the latter two categories.

Plaintiff brought three warranty claims – breach of express warranty, breach of implied warranty of merchantability, and breach of implied warranty of fitness for a particular purpose.  All three failed for two reasons.  First, Alabama law requires pre-suit notice to the seller as a pre-condition to any warranty claim.  Id. at*2.  Plaintiff’s first amended complaint alleged only that “upon information and belief” either he or his health care providers provided pre-suit notice.  But not only was that conclusory allegation missing the who, it was also missing the when, how, and to whom.  Id.  What it confirmed for the court was that plaintiff “has no knowledge personally or otherwise, that any pre-suit notice was ever provided.”  Id.  Plaintiff claimed this was information that would come out in discovery, however, a conclusory complaint does not throw open those doors.  Moreover, plaintiff should not need discovery to know whether he himself gave notice.  Without “some degree” of specificity or a factual basis to support a claim of pre-suit notice, plaintiff’s warranty claims had to be dismissed.

The second reason for dismissing the express warranty claim was TwIqbal.  Plaintiff failed to plead anything about where or how he received the alleged warranties or whether the defendant “communicated these affirmations to [plaintiff] directly.”  Id. Plaintiff apparently pointed to the device’s Indications for Use (“IFU”), but the IFU is not a warranty of safeness.  The IFU describes the device and its uses.  It also provides warnings and possible complications, including the risk of clotting.  Perhaps more importantly, the IFU is a communication from the manufacturer to healthcare providers; or the learned intermediaries.  Nowhere did the first amended complaint allege how the purported warranty passed from plaintiff’s prescribing physician to him.  Id. at *4.        

The second reason for dismissing the implied warranty claims is because Alabama law does not allow such claims for inherently dangerous products such as medical devices.  Rather, Alabama has decided that allegations of harm caused by medical devices and prescription drugs should be “addressed by claims under tort theories” rather than under the UCC.  Id. at *5. 

Moving on to fraud, plaintiff failed to plead these claims with the heightened specificity required by Fed.R.Civ.P 9(b).  Plaintiff left out of his complaint the “time and place” of the allegedly fraudulent statements, the content of the statements, and what he relied on that induced him to agree to the implantation of the device.  Id. at *6.  That warranted dismissal of his fraudulent misrepresentation claims.  Plaintiff also alleged fraudulent suppression.  Under Alabama law, a party who is obligated to communicate a material fact and does not do so can be liable for fraudulent suppression.  Id.  But the “duty to speak” depends on several factors including the relationship between the parties.  When parties deal with each other at arms’ length, there is no duty to disclose.  While plaintiff alleged defendants had a duty to disclose to his physician, he did not allege any “confidential or special relationship” between himself and the defendants.  Therefore, plaintiff’s fraudulent suppression claim was also dismissed.  Id.

Finally, plaintiff had already amended his complaint once in response to a prior motion to dismiss—with only minor changes and none that remedied the deficiencies in these claims.  The court was not inclined to give him another opportunity.  Id. at *7.  So, these claims are dismissed with prejudice.