Today’s post is for procedure geeks, especially those who litigate MDLs.

Offensive non-mutual collateral estoppel prevents a defendant from relitigating an issue that it lost in earlier litigation against a different plaintiff.

The issue is when offensive non-mutual collateral estoppel applies to a case that was part of an MDL. More specifically, the issue is which state’s law determines whether offensive non-mutual collateral estoppel applies in a particular case.

Before we discuss a recent case that provides a dubious (albeit helpful in the instance) answer to that question, a few words on some of the reasons why offensive non-mutual collateral estoppel is a bad idea, especially from a defense perspective.

Offensive non-mutual collateral estoppel risks perpetuating an erroneous result by preventing relitigation of issues already decided against a defendant. If the defendant loses the first case to reach final judgment, the doctrine gives disproportionate, preclusive weight to the decision of a lone judge or jury, no matter how wrong that decision.

The fact that an adverse judgment in the first case to reach final judgment can cripple a company’s defense in subsequent cases has two adverse consequences apart from the danger of perpetuating error. First, it gives the plaintiff tremendous leverage in settlement negotiations. Second, it induces defendants to spend much more litigating a case than would be warranted by the amount nominally in dispute.

Because it can cripple a company’s defense, offensive non-mutual collateral estoppel can be outcome determinative. Thus, the question whether it applies in a particular case is an important question when it arises. It is especially important in MDLs (and other coordinated proceedings) given the larger number of follow-on cases in which the doctrine could theoretically be invoked.

The impetus for today’s post is Dalbotten v. C. R. Bard, Inc., 2022 WL 2910125 (D. Mont. 2022), a case that had been part of the G2 IVC filter MDL in the District of Arizona but was then sent to the District of Montana for further proceedings. Asserting a failure-to-warn claim under Montana law, the plaintiff moved for summary judgment, arguing that the defendant was precluded from litigating the adequacy of its warning because a jury in a bell-weather case tried by the MDL court in the District of Arizona under Georgia law had previously found the warning inadequate. For reasons it does not adequately explain, the Dalbotten court concluded that Arizona law governed whether offensive non-mutual collateral estoppel applied. That was good for the defendant, because Arizona does not recognize the doctrine, but serious choice-of-law questions linger.

As the Dalbotten court recognized, the Supreme Court has held that in diversity cases a district court evaluating the applicability of offensive non-mutual collateral estoppel should follow “‘the law that would be applied by state courts in the State in which the federal diversity court sits.’” 2022 WL 2910125, at *2 (quoting Semtek Int’l Inc. v. Lockheed Martin Corp., 531 U.S. 497, 508 (2001)).

Given this rule, one would think that the District of Montana would have applied Montana law when deciding whether the doctrine applied in Dalbotten. But instead it applied Arizona law.

Why? According to the court:

It is undisputed that this matter is a federal diversity case and a federal district court sitting in Arizona rendered the prior judgment at issue. Therefore, it should be rather straightforward that Arizona law applies to the preclusion determination.

2022 WL 2910125, at *2. But that conclusion does not follow from—and, indeed, seems contrary to—the rule that a federal court sitting in diversity applies the law of the state in which it sits.

The Dalbotten court did not explain the relevance of the fact that the prior judgment had been rendered in Arizona, where the MDL court was located. And it is hard to see the relevance. MDLs are a transitory procedural mechanism that should not affect substantive rights.

That said, the plaintiff’s arguments in favor of applying offensive non-mutual collateral estoppel were even less persuasive than the court’s reason for not applying the doctrine. The plaintiff argued that Arizona recognizes the doctrine and that even if it didn’t the question is governed by federal law. Neither assertion is correct. Arizona does not recognize the doctrine, and the Supreme Court has squarely held that state law governs the question in diversity cases.

So, we are left to ponder what law controls application of offensive non-mutual collateral estoppel in a case that had been part of an MDL. Is it the law of the state where the MDL was located, and where perhaps a bell-weather trial was held? Is it the law of the state whose substantive law governs the case? Is it the law of the state where the case is being heard?

Supreme Court precedent suggests that the question is controlled by the law of the state where the case is being heard. One could also imagine arguments in favor of applying the law of the state whose substantive law governs the case.

Dalbotten, however, applied the law of Arizona, which is neither the state where the case is being heard nor the state whose substantive law governs. Dalbotten did not say whether it did so because that is where the MDL was located or because that is where the bell-weather trial was held. If it applied Arizona law because that is where the MDL was located, the court, without analysis, adopted an MDL-specific rule. If it applied Arizona law because that is where the purportedly preclusive judgment was rendered, the court, without analysis, prioritized where the earlier judgment was rendered over where the subsequent case is being heard.

In Dalbotten, it probably did not matter whether the court applied Arizona or Montana law. As the court held, Arizona does not recognize offensive non-mutual collateral estoppel. And a moderately diligent search of Montana precedent and federal cases applying Montana law revealed no case recognizing the doctrine, which is likely why the plaintiff did not argue for application of Montana law.

Even if immaterial to the outcome in Dalbotten, it would be nice to have greater clarity on which law controls application of offensive non-mutual collateral estoppel. At minimum, MDL practitioners should be aware of Dalbotten. If the law of the state where the MDL is located governs subsequent application of the doctrine, practitioners will have to take that into account in deciding where MDLs are best located.


Even a meritless lawsuit can impose an enormous burden on a company.   There is the ridiculous expense, of course.  Legal fees and other costs of defending a lawsuit can easily add up to more money than most juries award to plaintiffs.  Some of those costs can be indirect but profound.   Employees who would prefer to be busy working on product improvements end up being distracted by deposition preparation, document collection, etc.  

That distraction is particularly annoying when plaintiff lawyers insist on deposing C-suite executives.  Such executives seldom know details as much as employees working closer to the ground. C-suite executives have their hands and calendars full orchestrating larger corporate strategies. Getting time to prepare such witnesses for depositions is not easy.  Stakes are high. So is the pressure. Time is shorter than we’d like.  Most of us have probably heard of awful soundbites from depositions of CEO’s and COO’s.  We once had the, er, pleasure, of seeing snippets from our client’s CEO deposition on 60 Minutes.

Moreover, because companies are sued so often, and because plaintiff lawyers take sadistic joy in sitting across a conference room table (real or virtual) from high-ranking executives, corporate executives could conceivably spend most of their time working on litigation than on their actual jobs.

Enter the Apex Doctrine.   Courts in most jurisdictions entertain motions for a protective order seeking to prevent or limit depositions of high level corporate executives,   The motion is typically supported by an affidavit demonstrating that the executive is a very high ranking, Apex employee who lacks unique personal knowledge about the issues in the case.  Then the party seeking the deposition bears the burden of showing that the relevant information sought cannot be obtained without the Apex deposition. The court then then weighs the interests. More often than not, there is no reason for the Apex deposition.  Plenty of alternative, less burdensome avenues of discovery exist. Sometimes the court will permit the deposition but limit the topics or time.  

Note that we earlier said that the Apex doctrine applies “in most jurisdictions.”  That is certainly true of federal courts.  In the recent case of General Motors, LLC v. Buchanan, 2022 WL 1750716 (Georgia June 1, 2022), the Georgia Supreme Court decided whether Georgia would be among those “most jurisdictions.”  The answer?  Not really, but almost. 

In Buchanan, the plaintiff brought a wrongful death action against GM, alleging that his wife was killed in a car accident due to a defect in her car’s electronic stability control system.  The plaintiff sought to depose the GM CEO.  That is about as Apex as one can get.  GM moved for a protective order preventing the deposition, arguing that the CEO lacked pertinent personal knowledge.  The trial court denied the protective order, holding that Georgia’s liberal discovery regime (Georgia does not employ the proportionality language, so the next time somebody asks whether such language makes any difference, now you have an answer) was inconsistent with the Apex doctrine, and that there was insufficient evidence that the plaintiff’s effort to depose the CEO was animated by bad faith.  The Court of Appeals affirmed, and then the Georgia Supreme Court granted certiorari.  

The Georgia Supreme Court took a tour through Apex doctrine case law.  The bad news is that the court “decline[d] to adopt any version of the apex doctrine that shifts the burden to the party seeking discovery.”  But general principles of Georgia discovery law can get pretty close to the Apex doctrine. The rule is that “a court must consider whether the deposition of a particular individual would cause ‘annoyance, embarrassment, oppression, or undue burden or expense’ based on, for example, that person’s scheduling demands or responsibilities and lack of relevant or unique personal knowledge that is not available from other sources.”  At the same time, high-ranking executives are not immune from depositions solely “by virtue of the positions they hold or the size of the organizations they lead.”  Thus, the Georgia Supreme Court rejected any sort of bright line rule.  If you think a bright line rule is necessary, and that a messy case-by-case analysis will be inefficient and inconsistently executed, the Georgia Supreme Court’s message to aggrieved parties is petition the Georgia General Assembly for a change in the law.

Turning to the particulars of the wrongful death case, the Georgia Supreme Court held that the trial court was correct in rejecting the Apex Doctrine.  But the Supreme Court also held that the trial court was incorrect in conditioning a protective order upon a showing that bad faith or harassment motivates the request for the deposition.  The Georgia discovery statute makes clear that issuance of a protective order depends “on the effect the proposed discovery would have on the party from whom the discovery is sought, not the intent or motivations of the requesting party.”  Thus, the Supreme Court overturned the trial court’s denial of the protective order and remanded for proper weighing of the factors supporting and countering the deposition.  The Supreme Court also disagreed with the suggestion by the Court of Appeals that relevance was the only relevant consideration and that GM’s Apex arguments could be ignored.  Rather, the Supreme Court instructed that the trial court must determine whether the movant demonstrated annoyance, embarrassment, oppression, or undue burden or expense.  Under that standard, most Apex depositions should be seen as the unnecessary, burdensome exercises that they almost always are.  

The Georgia Supreme Court did not go as far as we’d like.  It did not embrace the Apex Doctrine, but it at least made a polite bow in its direction.

Since the Supreme Court decided Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), product liability litigation over childhood vaccines is rare but not extinct.  As demonstrated by today’s case — Garcia v. Sanofi Pasteur Inc., 2022 U.S. Dist. LEXIS 134330 (E.D. Cal. Jul. 28, 2022).  And while the decision does discuss preemption, this case was largely sunk by a complete failure to meet federal pleadings standards.

Plaintiff alleges that after receiving a pneumonia vaccine and a TDaP vaccine, she developed a partial tear of right rotator cuff.  Id. at *1-2.  She brought strict liability design defect, failure to test, manufacturing defect, and failure to warn claims, as well as general negligence claims against both manufacturers who both moved to dismiss.  First, the plaintiff conceded that she could not bring a design defect or a failure to test claim, so both were summarily dismissed.  Id. at *4-5, *10-11. 

The discussion of the manufacturing defect was more involved.  TwIqbal requires plaintiff to plead how the product deviated from the product’s intended design or from other identical products.  Plaintiff relied on three allegations in her complaint arguing they met the pleading requirement.  The first paragraph alleged the vaccine was defective in manufacture at the time it left the possession of the defendant.   Missing is any allegation about the condition of the vaccine at the time it was administered and, more importantly, it is only a conclusory allegation that a defect exists.  The second paragraph alleged that it was foreseeable the product would be used without inspection or testing for defects.  That too is a conclusory allegation “devoid of any factual content.”  The third allegation was that the vaccine was used in a foreseeable manner for its intended purpose.  Once again, no facts to suggest “either directly or circumstantially” that the vaccine had a manufacturing defect.  Id. at *6-9. 

Plaintiff argued that the court was setting too high a bar that could only be met by “pinpoint[ing] specifically where in the manufacturing process the alleged defect occurred.”  Id. at *9.  Plaintiff relied on an outlier case that set a much lower standard.  But even in that case the court required “a factual proposition—that the drug was not made in accordance with [the manufacturer’s] specifications.”  Id.  Plaintiff here could not even hurdle that low bar as her complaint contained no “factual allegation” only regurgitation of the elements of the claim.

To survive a TwIqbal challenge on her failure to warn claim, plaintiff was required to identify the risk that was not warned against, explain why that risk was substantial, and that the risk was known or reasonably knowable or explain how the warning was inadequate.  Id. at *11-12.  Here plaintiff tried to pull the old switcheroo—substituting a California state standard for the federal TwIqbal standard.  Plaintiff relied on a state court case describing the difference between negligent and strict liability failure to warn.  In other words, the state court decision simply stated the legal standard not a pleading standard, federal or otherwise.  In federal court, more is required that just repeating the legal standard.  Id. at *12-13.  All plaintiff alleged was that the defendant failed to warn of known dangers without even identifying what that danger was or whether it was known or reasonably knowable. 

Plaintiff tried the same argument on her negligence claims.  Citing mostly state court cases, she argued that her pleadings were sufficient because they mirrored the elements of her negligence claims.  That’s a big no-no under TwIqbal.  Without any factual allegations to even suggest defendants were negligent in their design, manufacture, or warning of the vaccines, this claim failed as well.  Id. at *14-17.

So, all of plaintiff’s claims were dismissed for insufficient pleadings, but the court still addressed the preemption argument.  The Vaccine Act established an injury compensation program for awarding damages compensation in a streamlined manner.  The trade off was that it imposed limitations on the availability of traditional tort remedies.  The Act expressly preempts design defect claims where the vaccine is accompanied by a proper warning (which is presumed if it complies with FDA requirements).  In this case plaintiff already voluntarily dismissed her design defect claims.  Defendants argued, however that the preemption should apply to her manufacturing defect claims as they are merely “re-packaged” design claims.  Id. at *20.  Since plaintiff only alleges the vaccines were defectively manufactured without alleging how they might be so, the court only could speculate as to whether the manufacturing claim was independent of the design claim.  The court was not willing to speculate and so deferred deciding this preemption issue until it could review a more detailed complaint.

Also expressly preempted by the Act are claims based on a failure to provide warnings to the claimant.  Plaintiff’s failure to warn claim was based on allegations that defendants failed to warn end users, which therefore should be preempted.   Plaintiff argued that two exceptions applied – where the manufacturer engaged in conduct that would be subject to punitive damages (intentional or wrongful conduct) or where there is clear and convincing evidence that the manufacturer did not exercise due care.  Id. at *20.  The decision discusses the “muddy waters” regarding whether those exceptions apply to failure to warn claims or just to design defect claims.  Id. at *22-23.  But regardless, because “the Complaint does not contain any non-conclusory factual allegations suggesting the absence of due care,” plaintiff did not plead any basis to apply the exceptions.  So, the court dismissed plaintiff’s failure to warn claim as preempted as well. 

Plaintiff is being given a second chance to plead her claims, which the first time around only parroted the elements of her claims.  And there is only one parrot we want more of these days, Mrs. Gambolini.

We scratched our heads last year when the Third Circuit misconstrued the federal PREP Act to allow a state-law negligence claim arising from an alleged COVID-related death, in direct contravention of the Act’s express preemption.  See Maglioli v. Alliance HC Holdings LLC, 16 F. 4th 393 (3d Cir. 2021).  The other shoe dropped the other day when a district court ruled that the PREP Act allowed a state-law negligence claim arising from administration of a COVID vaccine, even though the Act clearly mandates that the exclusive cause of action is a willful misconduct claim under federal law.  See Roeder v. Ann Terry, No. 5:22-cv-01796, 2022 U.S. Dist. LEXIS 127474 (E. D. Pa. July 19, 2022). 

This is the exact scenario that the PREP Act was enacted to address.  So how did this happen? 

As we have explained here, Congress enacted the Public Readiness & Emergency Preparedness Act (“PREP Act”) in 2005 to ensure the availability of effective countermeasures in the event of public health emergencies.  Thus, when the Secretary of the Department of Health and Human Services declares a public health emergency (such as COVID-19), the Act provides that a “covered person” shall be immune from liability under state and federal law with respect to all claims relating to “covered countermeasures” (such as vaccines). 

To repeat what we wrote here, rather than allowing such claims, the Act establishes a fund to compensate “eligible individuals for covered injuries” through an administrative remedy.  There is only one exception:  The PREP Act provides “an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct.”  Roeder, at *7-*8 (quoting 42 U.S.C. § 247d-6d(d)(1)).  The Act also expressly preempts contrary state law, so long as the Secretary’s emergency declaration is in place.  See 42 U.S.C. § 247d-6d(b)(8) (preempting any state requirement “with respect to a covered countermeasure” that is “different from, or is in conflict with, any requirement” under the Act). 

Because the Secretary has declared COVID-19 to be a public emergency multiple times, the Act’s operation should not be complicated:  A person who claims injury arising from a COVID vaccine can apply for compensation through an administrative claim, or he or she can file a lawsuit alleging willful misconduct under federal law. 

The plaintiff in Roeder did neither.  After her spouse sadly passed away following a COVID vaccine, the plaintiff filed a lawsuit in state court alleging negligence.  Roeder, at *1-*2.  Because the PREP Act preempts state-law claims and provides an exclusive remedy under federal law, the defendants removed the case to federal court.  Id. at *2. 

This is where the Third Circuit’s precedent did its damage.  Following Maglioli, the district court applied a two-step process to determine whether the plaintiff’s state-law claims were preempted and thus removable to federal court.  “First, the Court asks whether the statute creates an exclusive federal cause of action.  If the Court concludes that the statute does create an exclusive federal cause of action, then the Court asks whether any of the Plaintiff’s claims fall within the scope of that cause of action.  If both steps are satisfied, then the claims are completely preempted and removable to federal court.”  Roeder, at *4-*5. 

The district court easily found that “the PREP Act clearly evidences congressional intent to create an exclusive cause of action.”  Id. at *5-*6.  The district court then inquired whether the plaintiff claims fell within the scope of the exclusive federal cause of action, i.e., whether the plaintiff alleged willful misconduct.  Id. at *7-*9.  It is difficult to understand the basis for this second inquiry.  An exclusive cause of action means exactly that—it is the only civil claim allowed, with all others being preempted.  It therefore makes no difference whether the plaintiff’s allegations are within the scope of the federal claim.  If she had any claim at all, it was under federal law, which is sufficient to support federal question jurisdiction.  Whether she sufficiently pleaded the claim is another question, but it is one that the federal courts had jurisdiction to address. 

The district court ruled that the plaintiff’s state-law negligence claim fell “outside the scope” of the exclusive federal remedy and thus was not preempted.  By remanding on this basis, the district court (and Third Circuit before it) created a paradox.  They interpreted an act of Congress to create an exclusive claim that is not exclusive.  Bexis would say that the courts have turned the PREP Act on its head, but we can’t help but think of the 1970’s Crystal Gayle song, Don’t It Make My Brown Eyes Blue

The PREP Act said “exclusive” (brown), but the district court made it “non-exclusive” (blue).  Go figure.  If anything, Roeder is even more head scratching then the Third Circuit’s opinion in Maglioli.  The Maglioli case involved a nursing home that allegedly failed to take sufficient measures to protect its residents against COVID.  That is to say, the plaintiff alleged nonfeasance.  In Roeder, the plaintiff’s claims arose directly from the affirmative deployment of a quintessential public health emergency countermeasure—a COVID vaccine.  The case is squarely within the PREP Act’s protective crosshairs. 

The impact of this re-colorization of the PREP Act could be very real.  Given the option of alleging a negligence claim under state law, and thus sidestepping the PREP Act altogether, no one will pursue the more exacting willful misconduct claim that the PREP Act expressly allows.  This threatens to reduce greatly the PREP Act’s protection, which Congress enacted for the stated purpose of ensuring access to effective countermeasures during public health emergencies.  Of course, the case is not over.  The Pennsylvania state courts will address the merits, and hopefully they will apply the protection that Congress enacted. 

Last term the newly empowered conservative majority on the Supreme Court demonstrated to all that precedent is not so precedential, even when it had stood for nearly fifty years.  They very nearly did it again, but just missed, targeting precedent on religious exemptions and vaccine mandates that has been around for more than twice as long.

Continue Reading Vaccine Mandates and Religion at the Supreme Court

Whaley v. Merck & Co., 2022 WL 1153151 (S.D. Cal. April 12, 2022), is an ugly example of overly grasping personal jurisdiction permitted in the service of facilitating an even worse overreach by a state’s substantive law.  We’ve repeatedly criticized the substantive theory – innovator liability – because (among other things) it exposes manufacturers to liability for claimed defects in competing generic drugs from which the defendants received no benefit (quite the opposite), and did not control what their competitors did.  Indeed, innovator liability strays so far from traditional product liability that it creates personal jurisdictional problems – since the target defendant often has no jurisdictional contacts whatever with the forum state, since it didn’t even sell the product that allegedly caused (very attenuated) harm.

Continue Reading California Court Overreaches on Personal Jurisdiction

We are patrolling the advance sheets for Rule 702 decisions as part of our preparation for an upcoming DRI panel.  Not all of the cases are brand-spanking new and not all are wonderful.  Consider Wood v. American Medical Systems Inc., 2021 WL 1178547 (D. Col. March 26, 2021), for example.   It is a vaginal mesh case that was remanded to federal court in Colorado.  

As we have pointed out more than once, the decisions in the pelvic mesh litigation generally improved with remands.  Any right thinking judge would rather get rid of a meritless case than waste tax dollars and juror time. But the remand courts were still stuck with some bad prior decisions.   In Wood, the plaintiffs moved to exclude testimony by the defense regulatory expert, while the defense moved to exclude or limit materials science and medical causation experts.

Let’s start with the plaintiff’s motion, just to get it out of the way.  Don’t stop us if you’ve heard this before; you have.  The defendant proposed to bring in an FDA expert who would explain to the jury how the vaginal mesh product had been cleared through FDA’s 510(k) process.  The plaintiff argued that such testimony was irrelevant and confusing, because the 510(k) clearance had nothing to do with safety.  The plaintiff prevailed in this argument, even though it is plainly wrong.  

The 510(k) process looks for substantial equivalence to another product on the market, and that substantial equivalence is a proxy for safety.  But the vaginal mesh MDL court, the Fourth Circuit, the Eleventh Circuit, and several disappointing district courts over read the SCOTUS decision in Lohr, which contrasted the rigorous Pre-Market Approval process for medical devices with the 510(k) “shortcut” (not everyone agrees with that characterization). The Lohr decision was about preemption, not admissibility. Moreover, Lohr’s analysis of 510(k) was outdated, as subsequent FDA pronouncements made clear that the purpose of the 510(k) process was to assure safety. Otherwise, why is “substantial equivalence” relevant?  

But the Wood case was hemmed in by bad precedents, so it excluded the defense regulatory expert —even though Colorado law provides a rebuttable presumption of no defectiveness if the product complied with federal or state regulations.  The mesh complied with section 510(k), but the Wood court followed a case interpreting a (somewhat) similar Utah statute and concluded that “the 510(k) process is focused on equivalence rather than safety, and therefore provides little protection to the public.” Ugh.  

The defendant also argued that the jury should at least learn of the “biocompatibility standards entailed in section 510(k) approval” since the issue of biocompatibility was front and center in the plaintiff’s claims.  But the Wood court did not see how that issue would have been treated any differently in those rotten precedents. (But was that issue even raised in those precedents?  Don’t we have a valid point of distinction?) 

Oh well.  You cannot mold gold out of clay, and you cannot make a good legal ruling out of Wood.

Or can you?  The Wood court did clamp down on some of the plaintiff experts, so let’s sample some of those rulings, if only to rinse the bad taste of the disappearing 510(k) out of our mouths.  First, the Wood court held that the plaintiff expert could not propose alternative medical procedures. They had nothing to do with whether the product at issue was defective. Second, the Wood court held that a plaintiff medical expert was not qualified to testify about the technical aspects of the mesh that allegedly caused medical harm.  Third, the Wood court held that the plaintiff medical expert’s opinions regarding complication rates were unreliable.  That expert seemingly plucked a 15% complication rate out of the air.  He could not adequately explain the basis for that figure, so the court excluded it.  Fourth, the Wood court held that a plaintiff medical expert (who seems to show up in every one of the pelvic mesh trials) was not qualified to criticize the defendant’s “testing deficiencies.” Fifth, the Wood court held that the plaintiff expert’s preference for different materials was both irrelevant and impermissible, because those other materials were unavailable to American patients for the indication at issue in Wood.  

To be sure, the Wood court let in some plaintiff expert opinions that, like the 510(k) exclusion, will paint a counterfactual, absurd picture for the jury.  For example, the Wood court permitted a plaintiff urology expert to hold forth on the (fictional) significance of a Material Safety Data Sheet.  

The Wood case is an illustration of the defects in the MDL process.  Theoretically, an MDL achieves efficiencies by facilitating centralized discovery and motion practice, followed by ready-to-go trials.  But what if the MDL rulings are bungled?  Efficient injustice is still injustice.

This post is from the non-Reed Smith side of the blog only.

Mismatch your socks – you’re bold.  Mismatch your shoes – you’re frazzled.  Mismatch plates on a dining table – your creating ambience.  Mismatch your pizza with pineapple – well don’t knock it until you’ve tried it.  Treat the law like it’s your socks – we’ve got a problem.

That’s what we think the court did in In Re Proton-Pump Inhibitor Products Liab. Litig., 2022 WL 2819158 (D.N.J. Jul. 19, 2022) when it chose to recognize that Ohio abrogated all common law products liability claims but also chose to allow plaintiff to assert the common law heeding presumption that was not adopted by the Ohio legislature in their enactment of the Ohio Products Liability Act (OPLA). 

There was no dispute in the case at issue that plaintiff was an Ohio resident who received his prescription for Nexium in Ohio and that therefore Ohio law applied.  Ohio courts adopted the heeding presumption in Seley v. G.D. Searle & Co., 423 N.E.2d 831, 834 (Ohio 1981) based on comment j to Restatement (Second) of Torts §402A (1965).  A comment that the American Law Institute has since decided was “unfortunate” and shouldn’t be followed. See Restatement (Third) of Torts, Products Liability §2, reporters notes to comment l (1997).  So, the heeding presumption is an outdated aspect of the Ohio common law.  Which may be why the Ohio legislature did not include it when it enacted OPLA in 1998.    

OPLA was not warmly received by the Ohio judiciary.  See Ohio Academy of Trial Lawyers v. Sheward, 715 N.E.2d 1062 (Ohio 1999) (declaring large chunks of earlier version of OPLA unconstitutional); Carrel v. Allied Products Corp., 677 N.E.2d 795, 796 (Ohio 1997) (declaring that, “all common-law products liability causes of action survive [OPLA] unless specifically covered by the Act”).  So, the Ohio legislature amended OPLA in 2005 to add §2307.71(B), which states that OPLA is “intended to abrogate all common law product liability claims or causes of action.”   

Based on that very clear pronouncement, the PPI MDL court granted summary judgement on plaintiff’s claims for negligent misrepresentation, fraud/fraudulent misrepresentation, and fraudulent concealment.  In re PPI, at *8-10.  Each of the claims was based on allegations that defendants made or omitted statements regarding the drug’s safety and efficacy which the court correctly concluded amount to failure to warn claims and were therefore subsumed by OPLA.  Id.

But when it came time to address that failure warn to claim under OPLA, the court veered from strict adherence to the statute.  Apparently, the legislature’s otherwise comprehensive abrogation of pre-statute common-law does not extend to the equally common-law heeding presumption that pre-statute, common-law decisions had created   Put another way, the court’s ruling is that OPLA abrogated the common law claim of strict liability failure to warn but did not abrogate the heeding presumption associated with that common law claim despite the fact the OPLA undeniably does not include or adopt the heeding presumption.  We should note that this analysis is not in the opinion.  The court took for granted the heeding presumption applied and if that was challenged, the court did not address it.

Rather than finding the heeding presumption abrogated, the court went on to interpret it in an extreme way — if any of a plaintiff’s multiple physicians dies before being deposed then the heeding presumption effectively becomes irrebuttable because the dead doctor is automatically “presumed” to follow whatever warning the plaintiff claims should have been given. Id. at *4-5.  We think, as defendants argued, that the lack of prescriber testimony should not strengthen plaintiff’s case but weaken it.  Without prescriber testimony, plaintiff “could not demonstrate that her physician would have acted differently had he been given a different warning.”  Id. at *5 (quoting Heide Heide v. Ethicon, 2020 U.S. Dist. LEXIS 48402, *11 (N.D. Ohio Mar. 20, 2020) (granting summary judgment for defendant where plaintiff failed to depose her prescriber).  Since plaintiff clearly bears the burden of causation under OPLA, this is the proper result in a post-OPLA world where pre-OPLA common law claims no longer exist. 

Since plaintiff’s initial prescriber was deceased, plaintiff got the benefit of the automatic presumption in this case.  But the court went on to scrutinize the testimony of his other two prescribers and found both were insufficient to rebut the heeding presumption.  We disagree with the court as to the prescriber who testified that he still considers the drug “safe and effective” and “nothing that he heard as the deposition [meaning what plaintiff considers should have been warned about] caused him to question [his] decision to prescribe Nexium to the plaintiff.”  Id. at *6.  If that does not rebut the presumption, we are not sure what does.   However, to get summary judgment the defendant has to demonstrate that “each and every” prescriber would not have changed his prescribing decision – so one out of three was not enough to win the day.

We confess:  we spend much too much time on a prominent social media platform.  We post way too many pictures of the Drug and Device Little Rescue Dogs.  We follow the progress of our impending addition, a Standard Poodle show puppy, currently in utero.  We engage in pointless, angry, political debate.  And we look at recipes we will never prepare.  One of our favorite recurring memes is the “you had only one job” meme.  A package of hot dog rolls is labeled “Hamburger Buns.”  A “One Way” street sign points into oncoming traffic.  Each of the boxes in a towering pile is emblazoned with “Do Not Stack.”  You get the idea.

Correct application of Fed. R. Evid. 702 is the “one job” of a judge considering a motion to exclude experts.   And there’s the rub in today’s case, in a cop-out recurring throughout the opinion.  Don’t get us wrong – there is a lot of good in Cantrell v. Coloplast Corp., 2022 WL 2806390 (D. Minn. July 18, 2022), including the ultimate result.  But it is pockmarked.  Let’s work our way through and you’ll see what we mean.

Cantrell is a pelvic mesh case.  The plaintiff’s pelvic organ prolapse (‘POP”) was repaired with the defendant’s polypropylene mesh implant, a product designed to be implanted trans-abdominally, not trans-vaginally (this becomes important).  The plaintiff alleged that she “continued to experience pain and pelvic floor dysfunction” after the mesh implant and that she needed several revision surgeries.  Cantrell, 2022 WL 2806390 at *1.   She disclosed six expert witnesses, and the defendant moved to exclude all of them.  We will take them in turn.

Urogynecologist/“design defect” expert:

The plaintiff disclosed a urogynecologist, who opined that the defendant’s “POP products [were] defectively designed, that the implantation of the . . . products [did] not result in superior functional outcomes, and that [the defendant] knew about problems with its transvaginal POP products.”  Id. at *2.  But here was the problem:  as we mentioned, the plaintiff was not implanted with a transvaginal product – hers was transabdominal.  The defendant argued that, as a result, the expert’s report did not encompass the product at issue.   The plaintiff contended that the report “pertain[ed] to the properties of mesh, not the method by which the mesh was implanted.”  Id.   Not so, as the court observed:  the report made clear that the defendant used the same mesh for all of its similar products but that the opinions pertained “specifically to the risks inherent in transvaginal implantation of pelvic-mesh implants.”  Id. (emphasis in original).  The court concluded, “. . . [B]ecause the opinions in [the expert’s] report pertain only to transvaginal implantation, [the] testimony would be unhelpful to a jury. . . . Accordingly the court grants [the] motion to exclude [the expert’s] testimony.”  Id.   So far, so good.

Polymer scientist:

The plaintiff’s polymer science expert sought to testify that the surface layer of polypropylene mesh degrades in the human body.   The defendant argued that the opinion was unreliable because peer-reviewed literature contradicted it.  The court held that that a conflict between competing scientific theories was “fodder for cross-examination;” that “Daubert neither requires not empowers trial courts to determine” which of such theories “has the best provenance.”  Id. (citation omitted).  But the court also said this – the first of many similar comments:  “. . . [D]isputes about the factual basis of an expert’s testimony ordinarily implicate the credibility—not the admissibility—of the testimony.”  Id. (citation omitted).   We submit that this assertion flies in the face of Rule 702.  To wit, the “factual basis” of an expert’s testimony is a key factor in determining the reliability of the expert’s methodology.  And the lack of a reliable methodology has always demanded exclusion of an expert’s opinion, under an honest application of the Rule.  This is the “cop-out” to which we referred and which, in our humble opinion, has been invoked to permit plaintiffs’ experts’ sloppy opinions to survive countless Daubert/Rule 702 motions.   The Rules committee knew this, and it is amending Rule 702 accordingly.  But stay tuned – there’s much more of this later in Cantrell.

Before we get to that, a little more about the polymer scientist:  the court granted the defendant’s motion to exclude the expert’s opinion that the human body attacks mesh implants with oxidants as long as the implants remain in the body, because the expert’s conclusion “overreach[ed] the limits set by the authors of the article on which he relie[d].”  Id. at *4.  It held that the expert could testify about the general process of mesh degradation, but not about the specific properties of the defendant’s mesh, as he sought to rely on analysis of a different company’s mesh implants.  And it held that he was not qualified to testify that antioxidants used to prevent degradation of the mesh were toxic, because he was not a toxicologist or a pathologist.  

Regulatory expert:

The plaintiff’s regulatory expert sought to offer the opinions that the defendant did not conduct adequate clinical testing on its mesh implants, did not include adequate warnings in the instructions for use (IFU) that accompanied the implants, and did not conduct adequate post-market surveillance on the products. 

The defendant argued that the expert was not qualified to testify about the adequacy of the defendant’s testing because she lacked relevant education and experience.   The court stated (cop-out #2), “[The expert’s] lack of experience with pelvic-mesh devices goes to the weight of her testimony, not its admissibility.” Id. at *6.   Again, as the Rules Committee emphasized in the course of the recent amendment proceedings, it has always been the case that every element of Rule 702—including qualifications—is a threshold admissibility question.   The new language of the Rule underscores this, but it was always the case.   If this expert lacked the qualifications to testify about pelvic mesh, she should have been excluded.  Plain and simple.

The defendant also argued that the expert was not qualified to testify about the adequacy of the defendant’s warnings because her career had focused on pharmaceuticals, not medical devices.  Moreover, the defendant argued, the IFU did not need to contain warnings commonly known to surgeons who prescribe the devices, and the expert was not a surgeon and could not opine about what surgeons did or did not already know.   What did the court say?  “Gaps in an expert’s qualifications or knowledge generally go the weight of the witness’s testimony, not its admissibility.”  Cop-out #3.

The defendant also argued that the expert’s proposed opinions about the adequacy of the warnings was inadmissible because the expert did not adequately explain the basis for her opinion and relied on an unreliable methodology.   What did the court say?  You guessed it — #4.  And #5 shows up in the next paragraph, discussing the literature on which the expert relied for her warnings opinions.   The court did exclude the expert’s opinions to the extent that they were based on adverse event reports about another company’s products and her opinion about whether the IFU provided adequate information for surgeons to obtain informed consent.  But it admitted her “post-market surveillance” opinions over the defendant’s arguments about their unreliability because . . . #6.

Psychiatrist:

The plaintiff disclosed a psychiatrist, who sought to testify that the mesh implant had injured the plaintiff’s mental health.  But the expert’s report made only a temporal connection between the mesh implant and the plaintiff’s declining mental health, and the court held that this was not sufficient to constitute a causation opinion. 

General causation expert – Dr. Bruce Rosenzweig:

And now we come to the general causation opinions of Dr. Bruce Rosenzweig, familiar to all who defend pelvic mesh cases.  Dr. Rosenzweig offered his usual opinions:

  • Safer alternative designs:  The defendant argued that Dr. Rosenzweig’s opinions about safer alternatives were unreliable.  The court did not include any detail about the proposed opinions, simply noting that Dr. Rosenzweig “base[d] his opinion on his experience with many of the alternatives he suggests, in addition to his review of medical literature and other materials,” and  concluding that “disputes about the factual basis go to weight, and not admissibility” (#7).  The court did exclude Dr. Rosenzweig’s “alternatives” to the extent that they were surgical procedures, not medical devices.
  • “Small pore, heavyweight” mesh:  The defendant sought to exclude Dr. Rosenzweig’s opinion that the defendant’s mesh was defective because it was “small pore” and “heavyweight,” arguing that the opinions were unreliable. The court held that Dr. Rosenzweig  had cited “multiple medical studies” for his characterization of the mesh, and that disputes about the factual basis go to . . . . You know the rest (#8). 
  • Degradation:  #9 and #10 occur in the context of the court’s decision to admit Dr. Rosenzweig’s opinion that mesh degrades in the body and his opinions about the clinical consequences of the supposed “degradation.”
  • The court did hold that Dr. Rosenzweig was not qualified to offer opinions about the design and testing of medical devices, and it excluded his opinions to the extent that they pertained only to mesh implanted transvaginally.

Specific Causation Expert (Gynecologist):

The plaintiff disclosed a gynecologist to offer, inter alia, specific causation opinions.   The expert opined that the plaintiff’s symptoms “were caused by the defects in the design, testing, and marketing” of the defendant’s product, and that they plaintiff’s symptoms were “the result of her body’s intrinsic foreign body reaction.”  Id. at *14.  But, the court emphasized, the expert “[did] not explain how the materials he reviewed support[ed] his opinion” that the mesh implant caused the plaintiff’s symptoms, and “his failure to include the reasons for his opinions [were] neither substantially justified nor harmless” as the defendant would not be able to prepare its cross-examination without this information.  The court excluded the expert’s specific-causation opinions for these reasons.  We think it was even simpler:  the expert did not identify a reliable methodology, so his opinions were inadmissible.  But the result was correct.  (We should mention that, on the way to this portion of the opinion, the court denied the defendant’s motion to exclude the expert as unqualified.  Guess why.  #11.)

Summary Judgment:

The defendant moved for summary judgment on all of the plaintiff’s claims.  The plaintiff opposed the motion only as to her claims for negligent design, strict liability design defect, and failure to warn.

As to the negligent design claim, the court noted that, “[u]nder California law, a plaintiff advancing product liability claims must prove that a defect in the product caused injury.”  Id. at *17 (citation omitted).  Without the (excluded) testimony of her specific causation expert, the plaintiff could not satisfy this element of her claim.  The strict liability design defect claim failed for this reason as well, but it would have failed in any event because California law does not allow strict liability claims for design defects in medical devices.  And the warnings claim, also doomed by the lack of specific causation testimony, failed for the additional reason that there was no evidence of “warnings causation” – the plaintiff’s implanting surgeon testified that he did not read the IFU and did not depend on what the company told him about the product.   As such, no alleged inadequacy of the defendant’s warnings could have proximately caused the plaintiff’s injuries.   Summary judgment granted on all three claims.

As we said at the beginning, there is a lot of good in Cantrell, including the final outcome.  But whenever the court faced a tough call – or rigorous analysis – of whether an opinion satisfied Rule 702, it threw up its hands and defaulted to “weight not admissibility.”  This is not what Rule 702 demands of a “gatekeeper,” and we only hope that the upcoming amendments drive this point home. In the meantime, as temperatures hover in the upper 90’s in the northeast and COVID proliferates, stay safe out there.

Three times previously we have “reported from the front” on the federal government’s efforts to dismiss False Claims Act litigation – ostensibly (and often ostentatiously) filed in the government’s name – after the government has concluded that the particular case is more bother than it is worth.  The most recent of those posts was late last year, and reported on Polansky v. Executive Health Resources, Inc., 17 F.4th 376 (3d Cir. 2021).

Continue Reading The FCA Front Moves To The Supreme Court