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Here is another guest post by Reed Smith‘s Kevin Hara examining the exclusion of a couple of slapdash expert witnesses, and the resultant grant of summary judgment. Since it is summer time, it is only fitting that he does so using baseball analogies. As always, our guest posters deserve 100% of the credit (and any blame) for what they write.

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Baseball has always held a special place in American society, and while it is no longer revered to the same degree as it once was, few things are more evocative of summer and tradition than this remarkable sport.  This guest blogger is admittedly biased, having spent the majority of his formative years in one of baseball’s true havens, St. Louis, Missouri, home of the team who wears the Birds on the Bat—the Cardinals.  Though the Redbirds are having a rough season, few sports franchises have enjoyed such sustained periods of excellence and perennial playoff contention, a laudable accomplishment for a midsized market team without the seemingly bottomless pockets of the New York and Los Angeles teams.  Remarkably, the Cardinals have not finished last in the National League in more than a century, since 1918, around the time World War I ended.  At its essence, success in baseball depends on preventing your opponent from scoring runs, relying on pitching and defense, and plating runs of your own based on your offense.  With the exception of this season, the Cardinals have generally excelled at the fundamentals, one of the reasons for their long-standing success. 

However, there is a truly spectacular story unfolding this year, as a phenomenal once-in-a-lifetime athlete, Shohei Ohtani of the Los Angeles Angels is in uncharted territory—as a dominant starting pitcher and nearly unstoppable hitter who just achieved the unparalleled feat of pitching a complete game shutout in the first game of a doubleheader and hitting two gargantuan home runs in the second.  Oh(tani), and in subsequent game he hit another home run.  He is, at the same time, a force in both run prevention and run creation, which combines, for this Cardinals fan, Albert Pujols and Bob Gibson.

This combination brings us to today’s case, MacSwan v. Merck & Co., 2023 U.S. Dist. LEXIS 103532 (W.D.N.Y. June 14, 2023).  While MacSwan may not be as sublime as the season Ohtani is enjoying, it is a best-of-both-worlds scenario, because the defendant successfully moved to exclude Plaintiff’s experts on causation and moved for summary judgment on Plaintiff’s failure to warn and breach of implied warranty claims, effectively playing both solid defense and winning offense in one fell swoop.  Incidentally, Fosamax litigation (a different MDL) has yielded some monumental decisions, including one of the worst cases of 2017 and the Supreme Court’s subsequent reversal.

Plaintiff ingested Fosamax, an oral bisphosphonate used to prevent and treat osteoporosis, and alleged it caused her to suffer osteonecrosis of the jaw (“ONJ”).  Id. at *1-2.  The court exercised its “gatekeeping” function under Rule 702 to assess whether the methodology underlying Plaintiff’s proffered expert testimony was “scientifically valid” and whether it could “be [properly] applied to the facts in issue.”  Id. at *3 (internal quotation marks and citations omitted).  Plaintiff had two experts, Dr. Morhaim, on causation and Dr. Merchant, a supposed treater.  Like Dr. Seuss, I’ll refer to them as M1 and M2, respectively.  Neither passed Rule 702 muster.  Id.

M1 was a periodontist with expertise in “oral implantology,” with a “full-time periodontal and implant practice,” and two decades as an expert legal consultant.  Id. at *6.  He opined Plaintiff’s “adverse dental condition was BRONJ, [ONJ associated with bisphosphonate use] and was directly due to her taking the oral medications Fosamax and Atelvia.”  Id. at *7.  M1 had read literature “pertaining to bisphosphonates,” and worked with patients taking such medications, requiring him to “understand and explain” the products’ risks and benefits—qualifying him to “opine generally regarding the diagnosis and treatment of ONJ.”  Id. at *8-10.  In addition to his general expertise, he sought to “offer general and specific causation opinions that Fosamax caused Plaintiff’s injuries.”  Id. 

However, M1 was the medical equivalent of a pinch hitter.  He “never treated or examined Plaintiff; . . .neither reviewed all of Plaintiff’s relevant medical and dental records, nor cite[d] to specific scientific studies or data to support his opinion.”  Id. at *7-8. (emphasis added).  In other words, M1’s opinion did not rest on sound methodology, leading the court to reject it:

[M1] testified in deposition that he had read relevant scientific literature during his career, including various articles mailed to his home, however, he could not cite any particular article and his report references no scientific literature or clinical data. This is not the level of scientific rigor that would be expected in his profession.

Id. at *12 (internal citations, brackets and quotation marks omitted).  His “informal discussions with colleagues and his diagnosis of ONJ in five patients taking bisphosphonates,” failed to provide a reliable basis for general causation because his experience was “confined” to those cases and entailed “diagnosing” the condition, not “ascertaining its causation.”  Id. at *12-13.  As the court aptly stated, his experience with any nexus between Fosamax and ONJ was “extremely limited.”  Id. at *13.  Plaintiff took a big swing and a miss on general causation for her first strike.

M1’s specific causation opinion was similarly suspect.  For instance, he reviewed only “some of Plaintiff’s medical records,” and did not review Plaintiff’s pre-2010 dental records, which documented she was already missing a number of teeth.  Id. at *13, 17.  Likewise, his conclusion that Plaintiff’s ONJ was “directly related to her bisphosphonate use” hinged on his theory that the “effects of Fosamax were present” in Plaintiff’s body for nearly 2 decades based on its lengthy half-life—an assertion for which he “fail[ed] to cite a source.”  Id. at *13.  M1 further admitted not knowing whether Fosamax remained pharmacologically active even if it remained buried in the bone for a prolonged period.  Id.  The court was unable to determine whether this half-life hypothesis was “based on sufficient facts or data.”  Id. at *14 (citation omitted).  M1’s reliance on his selective review of Plaintiff’s treatment records further undermined the reliability of his opinion that Plaintiff even had BRONJ, as did his failure to properly exclude potential alternative causes—such as a partial denture and smoking—which he admitted could cause dental infections.  Id.  at *17-18.  Nor did M1 adequately account for the effects of Atelvia, another oral bisphosphonate Plaintiff ingested, despite acknowledging it carried similar risks of ONJ.  Id. at *21.  He inexcusably saw “no reason to [rule out alternative causes],” based on his conclusory testimony that “if the patient is on [Fosamax] and there is clinical evidence of BRONJ, then it’s related and caused by that medication being in the patient’s system”—a BRONJ diagnosis “by definition.”  Id. at *19. (internal quotation marks and punctuation omitted).  This is quintessential ipse dixit testimony that falls far short of Rule 702 standards, and the court agreed, excluding all M1’s causation opinions because they lacked the requisite reliability, and allowing him to offer such opinions would be “highly prejudicial.”  Id. at *22-23.  After another swing and a miss on causation, Plaintiff was now down two strikes.

Plaintiff attempted to have her treating infectious disease specialist M2 offer an opinion based on his treatment that plaintiff had osteomyelitis and that her CT scan showed ONJ, but like M1 (in addition to not being disclosed under Rule 26), that opinion was riddled with unreliability.  For instance, ONJ is not an infectious disease, and M2 had neither researched nor lectured regarding oral bisphosphonates, and had no training as a dentist or oral surgeon.  Id. at *23.  Nor did he review Plaintiff’s medical or dental records or speak to Plaintiff’s dentists.  That’s a lot of “nots,” but the worst was that M2 was “unaware of when, how long, and what dosage” of Fosamax Plaintiff ingested.  Id. at *24.  M2 admitted Plaintiff was diagnosed with BRONJ prior to his examination, and he examined Plaintiff only twice.  Id. at *25.  Therefore, the court limited any testimony to his treatment of Plaintiff on those occasions, including review of CT scans and lab records and his observations of such information.  Id. at *27.  However, recognizing treating physicians attempting to offer causation opinions are subject to Rule 26, the court prohibited M2 from so opining—“including any opinion in Plaintiff’s medical records that she had BRONJ” which would “impermissibly allow him to serve as a conduit for another witness’s testimony.”  Id. at *28 (emphasis added).  This was Plaintiff’s third strike on causation, and in baseball terms, she—and any expert causation testimony—was now out.

Next, it was the defendant’s turn to step to the plate, moving for summary judgment.

Although there were disputed facts regarding the timing and duration of Plaintiff’s Fosamax use, they were not material to Plaintiff’s claims regarding the adequacy of the warning label, the alleged failure to warn Plaintiff’s prescribing physician, or breach of the implied warranty of merchantability.  Id. at *41-42.  Plaintiff asserted negligence and strict liability failure to warn claims, which are analyzed identically under New York law, under the standard of what a reasonable manufacturer knew or should have known.  Id. at *42.  To prevail on a failure to warn claim, Plaintiff had to prove that the defendant’s warning to the prescribing physician was inadequate and that such inadequacy caused her alleged injuries.  Id. at *43.

Plaintiff started taking Fosamax in 2001, and he argued Defendant’s failure to update its warning label to include information about the risk of ONJ until 2005 was actionable.  Id. at *45.  Putting aside that defendant could not unilaterally alter its label using the FDA’s Changes Being Effected regulation, based on the court’s exclusion of M1’s and M2’s testimony, Plaintiff could offer “no admissible expert testimony regarding a causal association between Fosamax and ONJ” prior to 2005.  Id. at *48-49.  Nor could Plaintiff fill that void by relying on expert testimony from other cases.  Id. at *49.  Expert testimony was necessary to address complex issues including the “causal relationship between Fosamax and ONJ” before 2005.  Id. at *50.  Absent such evidence, Plaintiff could not show any warning inadequacy in the Fosamax label, negating an essential element of her failure to warn claim.  Id.  So medical causation was absent.

However, even if the pre-2005 Fosamax label’s warning were inadequate, Plaintiff still “must demonstrate that had a different, more accurate warning been given, her physician would not have prescribed the drug in the same manner.”  Id. (internal quotation marks, punctuation and citations omitted).  Plaintiff failed to produce evidence that her prescribing dentist would have changed or discontinued her Fosamax if the drug had carried a different warning.  Id. at *50-51.  Rather, Plaintiff admitted her treater continued to prescribe Fosamax after the 2005 ONJ warning label update, and in 2007 her dentist knew about the “association between oral bisphosphonates and ONJ, but he also did not advise Plaintiff to cease taking them.”  Id. at *51.  As such, the failure of Plaintiff’s physicians to change their prescribing behavior, despite knowledge of the purported risks of ONJ meant Plaintiff could not prove any warning inadequacy proximately caused her alleged injuries.  Id.  Accordingly, the court granted summary judgment because there was no triable issue of fact “as to the adequacy of Defendant’s pre- or post-2005 warnings and whether Plaintiff’s treatment providers altered their prescribing decisions if a different [warning] was provided.”  Id. at *52.  Warning causation failed as well.

Plaintiff’s breach of implied warranty claim required her to establish “the product was not minimally safe for its expected purpose—without regard to the feasibility of alternative designs or the manufacturer’s reasonableness” in marketing the product.”  Id. at *53 (internal quotation marks and punctuation omitted).  Plaintiff produced no evidence that Fosamax was not “minimally safe,” as M1 admitted the risk of Plaintiff developing ONJ was “very low,” and that Fosamax’s benefits exceeded its risks.  Id. at *54.  The court granted summary judgment on Plaintiff’s implied warranty because she failed to show Fosamax was not “minimally safe.”  Id. at * 55.

In addition to pitching a shut out by successfully moving to exclude Plaintiff’s expert testimony on general and specific causation, Defendant successfully went to bat and hit a game-winning summary judgment home run.  As the Cardinals’ long-time Hall of Fame broadcaster Jack Buck used to declare at the end of every triumph, “That’s a winner!”

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It is time, once again, to talk about Multidistrict Litigation (MDL) case management.  But this time there will be more gratitude than grousing.

We wince when we hear judges talk about managing litigation.  Such management seems to be about many things (mostly about forcing settlement), and not much about deciding legal issues, and definitely not enough about disposing of garbage cases.  Litigation mismanagement, or nonmanagement, is an especially vexing problem in MDLs. Take a look at a docket sheet for an MDL and you will see many Case Management Orders (CMOS).  But do those CMOs have any teeth?  Often, not.  Plaintiffs still park meritless cases in MDLs, waiting to get their crumbs from inventory or global settlements.  

But sometimes a CMO in an MDL truly can have a salutary effect, even if some waiting is involved.  That’s what happened in In re Taxotere Docetaxel Prods. Liab. Litig., 2023 U.S. Dist. LEXIS 144998 (E.D. La. Aug. 18, 2023).  By now, most of you probably have some sort of handle on the Taxotere litigation.  Plaintiffs claimed that a chemotherapy drug caused permanent alopecia.  The claims brought included failure to warn and misrepresentation.  

Three plaintiffs in the Taxotere MDL failed to serve the defendants for several years, in complete disregard of CMO 35 in the MDL, which provided that “it is Plaintiffs’ responsibility to ensure that service is effected on or before August 31, 2022, after which Plaintiffs’ claims against no served Defendants will be subject to dismissal with prejudice in accordance with Federal Rule of Procedure 4(m).”  Rule 4(m) permits the court to dismiss a case without prejudice if the plaintiff fails to serve a defendant within 90 days of filing the complaint.  That’s all fine and good, but a dismissal without prejudice is not such a big deal.  (We used to call it lukewarm beer, and then we discovered that some lukewarm beer was pretty good.) A much much much better dismissal with prejudice is warranted when “there is a clear record of delay or contumacious conduct by the plaintiff” and “lesser sanctions would not serve the best interest of justice.” Dismissals with prejudice in the Fifth Circuit typically include considerations as to whether the delay was caused by the plaintiff or the attorneys, whether the defendant suffered actual prejudice, and whether the delay was caused by intentional conduct.  The defendants in the Taxotere MDL filed a Fed. R. Civ. P. 12(b)(5) motion to dismiss for lack of service.  The defendants thought they had a clear case of inexcusable delay and contumacious conduct.  They were right.

At a July 2022 status conference, the court issued a “final opportunity and direct warning” to all plaintiffs in the MDL that they needed to comply with CMO 35 and effect service by August 31, 2022.  One of the three plaintiffs tried to effect service in October 2022.  The other two did not even make that tardy effort.  The plaintiff who was tardy argued excusable neglect, based on the attorney’s good faith belief that there had been effective service.  The other two not even assert an excuse; rather, they argued that a Rule 4(m) dismissal without prejudice would actually be with prejudice, because the claims would be time-barred, and that the conduct at issue did not meet the heightened test (“contumacious” – remember?) for a dismissal with prejudice.  

Under Fifth Circuit precedent, the court had ample discretion.  A court could extend the time for service even when good cause is lacking, and one reason might be concern that the applicable statute of limitations would bar the refiled action. Why a court would ladle out such ill-conceived mercy is well past the capacity of our flinty hearts to understand.  But no worries (from the defense perspective) here, because the plaintiffs had earned no mercy. They had gone at least three years, and as many as five, in not serving the complaints.  We’ve been throwing the word “contumacious” around a bit, so let’s get the Taxotere court’s definition of that term: it is “the stubborn resistance to authority which justifies a dismissal with prejudice.” A classic form of such stubborn resistance is willful disobedience of a court order.  

That is precisely what happened here. The court gave a direct warning and issued a clear CMO that the plaintiffs willfully disregarded. The court, consequently, refused to exercise its discretion to ignore Rule 4. What about the fact that dismissal now would make refillings too late?  Too bad.  Indeed, the court saw the statute of limitations as the source of actual prejudice to the defendants.  Dismissal, not some lesser sanction, is warranted due to the prejudice to the defendant resulting from the failure to serve process within the statute of limitations period.  Defendants are entitled to peace after the statute of limitations expires.  

In the end, time is the most precious resource.  Time is undefeated. As Auden wrote, “Oh let not Time deceive you/you cannot conquer Time.”

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St. Louis City courts have long been considered among the most pro-plaintiff in the country and for years litigation tourists flocked there using multi-plaintiff complaints with a single city resident to secure the venue.  Then the world changed in 2019.  The Missouri Supreme Court decided State ex rel. Johnson & Johnson v. Burlison, 567 S.W.3d 168 (Mo. 2019) and later that year the legislature codified the ruling.  Not only was Missouri’s permissive joinder statute changed to prohibit altogether the joinder of multiple plaintiffs simply because they were suing over the same product, but Mo. Stat. §508.010 was amended to establish that in “tort” cases, the venue as to the “individual plaintiff” for an action against a foreign corporation shall be:

in any county where a defendant corporation’s registered agent is located or, if the plaintiff’s principal place of residence was in the state of Missouri on the date the plaintiff was first injured, then venue may be in the county of the plaintiff’s principal place of residence on the date the plaintiff was first injured[.]

§508.010(5)(1). 

And just recently the Missouri Supreme Court had the chance to put these changes into action in State ex rel. Monsanto Company v. Mullen, — S.W.3d –, 2023 WL 5229516 (Mo. Aug. 15, 2023).  Plaintiffs were six non-Missouri residents who had filed lawsuits in St. Louis City.  Some were on multi-plaintiff complaints filed pre-2019 and some were more recently filed single-plaintiff claimants.  Id. at *1.  Defendant moved to transfer venue to St. Louis County in five of the six cases.  That motion was denied.  The six plaintiffs moved to consolidate their claims and schedule a joint trial.  That motion was granted.  Defendant moved for reconsideration of the consolidation order and reiterated its improper venue arguments.  That motion also was denied, and the case was set to begin trial in January 2023.  Defendant filed a writ of mandamus or prohibition to the Missouri Supreme Court.

The question before the Missouri Supreme Court was “whether venue is determined based on a defendant corporation’s registered agent’s location at the time the suit is filed or based on the agent’s location on the date of a plaintiff’s first alleged injury.”  Id. at *2.  That was a significant issue because defendant had relocated its registered agent from St. Louis City to St. Louis County between the time of alleged first injury and the time the complaints were filed. 

The applicable statutory provision is the one cited above and as the Missouri Supreme Court noted, tense is important.  The statute uses the present tense to describe the relevant location of the corporation’s registered agent – is not was.  The use of both the present and past tense in the same statutory subdivision, “is a significant indicator in statutory construction,” and confirms that use of the present tense when discussing registered agents “was not accidental.”  Id. at *3.

The court’s interpretation is also consistent with the purpose of the registered agent, to receive service of process.  Id. So, the county where the defendant chooses to site its agent for service of process at the time of suit controls venue when the plaintiff is an out-of-state resident.  As provided in §508.010(5)(1), the result is different when if the plaintiff is a Missouri resident.  Then, venue is where plaintiff resided (past tense) at the time of first injury. 

Plaintiffs argued that the court need to read §508.010(5)(1) in conjunction with Mo. Stat. §508.010(9) which provides that: “In all actions, venue shall be determined as of the date the plaintiff was first injured.”  That language is used in multiple sections of §508.010, but only in reference to determining venue based on plaintiff’s principal place of residence.  The legislature conspicuously omitted that language from the section dealing with venue based on a corporation’s registered agent which applies to out-of-state plaintiffs.  The language of §508.010(5)(1) also applies “[n]otwithstanding any other provision of law.” 

Therefore, because defendant’s registered agent at time the suits were filed was in St. Louis County, the Missouri Supreme Court found the circuit court exceeded is authority by refusing to transfer venue as defendant requested. 

However, the Missouri Supreme Court did make a few other noteworthy procedural holdings/comments.  First, waiver will be enforced if the venue issue is not timely raised in the first instance.  The court was not willing to mandate transfer for the sixth plaintiff because defendant did not challenge venue within the 60 days allotted by Rule 51.045(a).  Defendant argued that their prior motion to transfer, filed two years earlier, applied to this sixth case when that case was subsequently consolidated with the others.  The court did not find the argument persuasive.  Id. at *4.

Second, the “filing of a writ petition on the eve of trial may be grounds for this Court in future [mandamus] cases to exercise its discretionary authority not to issue the writ.”  Seven months elapsed between the circuit court’s denial of the motion to reconsider and defendant’s seeking the writ.  The takeaway– timeliness of challenging venue, both in the trial court and on appeal, is recommended.

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We closed our post on the terrible Supreme Court decision in Mallory v. Norfolk Southern Railway Co., 143 S. Ct. 2028 (2023), with this “stay tuned” message:

Finally, as all the Mallory opinions make clear, jurisdictional litigation in Mallory itself is not over.  The Pennsylvania Supreme Court’s interpretation of the Pennsylvania statute has not been challenged, and the litigation has been remanded for further proceedings – which will certainly include the dormant Commerce Clause issues raised in the Alito concurrence.

Indeed, as soon as Mallory was remanded, the defendant/appellee did just that, filing its “Application to Set a Briefing Schedule on Remand from the U.S. Supreme Court or, Alternatively, to Exercise King’s Bench or Extraordinary Jurisdiction” on July 28, 2023.

The application recalled the Pennsylvania Supreme Court’s unanimous conclusion that “Pennsylvania has no legitimate interest in a controversy,” like Mallory, “with no connection to the Commonwealth that was filed by a non-resident against a foreign corporation that is not at home here,” Mallory v. Norfolk Southern Railway, 266 A.3d 542, 567 (Pa. 2021) (“Mallory I”), and sought to have the court apply that conclusion, on remand, to the dormant commerce clause (“DCC”) issue identified in Justice Alito’s partial concurrence in Mallory v. Norfolk Southern Railway, 143 S. Ct. 2028 (2023) (“Mallory II”).  See our posts here, discussing Mallory I; and here, discussing Mallory II.

The Mallory defendant/appellee argues that the Pennsylvania Supreme Court should decide the issue on the current appeal – without further remand – either on the basis of its existing jurisdiction over the remanded appeal, or under a Pennsylvania peculiarity, the court’s “Kings Bench” power.  Appellate jurisdiction already exists, the application argues, as an ordinary remand in the course of the appellate review of the constitutionality of the Pennsylvania long arm and corporate registration statutes.  Application at 8-10 (relying on 42 Pa. C.S. §722(7)).  Alternatively, because of the potential burden on the court system from a flood of litigation unrelated to anything that happened in Pennsylvania, the court should exercise its supervisory Kings Bench power and decide the DCC issue on that basis.  Id. at 10-12 (“King’s Bench jurisdiction allows the Court to exercise power of general superintendency over inferior tribunals even when no matter is pending.”) (citation and quotation marks omitted).  The importance of the issue is unmistakable:

That question is uniquely important to Pennsylvania, as only the Commonwealth has a long-arm statute that explicitly asserts general jurisdiction based solely on corporate registration.  And Mallory II has significantly raised the profile of this issue − if the Commonwealth’s unique law flew somewhat under the radar before, it is now front-page news.  As a result, potential litigants across the country and the world now have reason to think that, if they want to sue a national or multinational corporation that does business in Pennsylvania − or is just registered to do business here − they can file in the Court of Common Pleas.  A deluge of litigation will likely result.

Application at 13 (citations omitted).

Beyond jurisdiction, defendant/appellee argues that, regardless of the Due Process status of its supposed “consent” by virtue of registering to do business in Pennsylvania, the DCC can preclude “assertions of jurisdiction over out-of-state companies in light of interstate commerce concerns.”  Application at 6 (citing Mallory II, 143 S. Ct. at 2052).  The Mallory application then discusses the DCC substantively, pointing out:

  • The DCC is violated by litigation imposing an undue burden on interstate commerce.
  • Suits with zero relation to the venue by definition create undue burdens on commerce under “Pike balancing” because no legitimate basis for exercising jurisdiction exists.
  • The same burdens exist for international as well as interstate commerce.
  • According the federal government’s amicus brief in Mallory II, Pennsylvania’s allowing registration-based jurisdiction “subverts interstate federalism” and “poses risks to international comity” while serving “no legitimate countervailing interest.”
  • Several United States Supreme Court decisions support the preclusive exercise of the DCC to the relevant Pennsylvania statute.
  • Pennsylvania’s imposition of registration-based jurisdiction discriminates against non-Pennsylvania companies and thus against interstate commerce.

Application at 15-21.

Finally the defendant/appellee’s Mallory application requested that the Pennsylvania Supreme Court order a new round of briefing and ultimately schedule oral argument on the DCC issue.  Id. at 22

Only three days after the application was filed, plaintiff/appellant Mallory filed “Appellant’s Response to Norfolk Southern’s Application To Set a Briefing Schedule.”  Much of the argument was misplaced, asserting that the defendant – who was the appellee – either didn’t preserve, or inadequately preserved the DCC issue.  Response at 2-3 (referencing “fail[ure] to preserve”).  Such waiver arguments betray a fundamental ignorance of appellate procedure because appellees, as opposed to appellants, cannot waive issues.  Indeed, an appellate court can affirm for any reason, even one not raised by the appellee at all.  Appellees simply “d[o] not bear the burden of issue preservation.”  Heim v. Medical Care Availability & Reduction of Error Fund, 23 A.3d 506, 511 (Pa. 2011).  “[A]n appellate court may affirm a valid judgment based on any reason appearing as of record, regardless of whether it is raised by the appellee.”  Commonwealth v. Moore, 937 A.2d 1062, 1073 (Pa. 2007).

[T]his Court, in its discretion, may sustain a valid judgment for any reason appearing of as of record.  This right-for-any-reason principle aligns with the recognition that it is the petitioner/appellant who has the greatest control over the framing of the issues presented in appeals, including discretionary ones.  It is only fair, then, that an appellee should be permitted to present the Court with other reasons why a judgment should be sustained after the matter is accepted for review.  Accordingly, Appellant’s contention that waiver considerations outside the four corners of an order allowing a discretionary appeal may not be considered is meritless.

Commonwealth v. Bishop, 217 A.3d 833, 839 (Pa. 2019) (citations omitted).

Otherwise, plaintiff/appellant Mallory’s response does not oppose rebriefing and reargument of the DCC issue.  “The parties agree that this Court will have jurisdiction to address the Commerce Clause argument” and “further agree that the Court should set a briefing schedule and that the Court should order oral argument.”  Response at 3.  Mallory proposed, first, that the appellee file the first “supplemental” brief, as if it were the appellant; and, second, that the appellant file a responsive brief, as if it were the appellee.  Id. at 3-4.  That’s odd, but Mallory’s third proposal, that appellee be denied any right to file a reply brief because it supposedly “had an obligation to raise all arguments in favor of affirmance in its initial briefs,” Response at 4, is simply wrong because as just discussed appellees have no such “obligation.”

The Response further proposes:  (1) successive thirty-day deadlines for briefing with the “usual leave” for extensions of time; (2) that both sides’ briefs be limited to 8,000 words; (3) that the participation of amicus curiae be allowed “consistent with Pa. R.A.P. 531 as if these supplemental briefs were the opening and responsive briefs on appeal”; and (4) that the Court schedule oral argument.  Id. at 4.

Thus, unless the Pennsylvania Supreme Court in Mallory were to act contrary to the positions of both sides, the DCC issue will be decided promptly, on this appeal without any intervening remand.  It remains to be seen how the Pennsylvania Supreme Court will respond to the Application in Mallory but it seems likely from the degree of procedural agreement between both sides, that the DCC issue will be briefed this fall, and oral argument probably scheduled before the end of 2023 (after the current one-justice vacancy on the court is filled by the November election).

Finally, while these developments appear to portend a relatively rapid process of deciding the Mallory DCC issue on remand from the United States Supreme Court – and a possible round two at the high court − there is always this caveat.  If at any time the plaintiff/appellee feels that he is likely to lose the DCC issue in Mallory, plaintiff can torpedo the entire appeal simply by dismissing his case.  Given the value of all the other litigation that turns on the registration-based jurisdictional question, the possibility of a third-party compensated dismissal in such circumstances always exists, since delay lets such litigation proceed.  Therefore, defendants in other cases based on Pennsylvania registration-based jurisdiction should continue to preserve and pursue the DCC issue, and not assume that Mallory will necessarily be decisive.

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Today we report on Farson v. Coopersurgical, Inc., 2023 WL 5002818 (N.D. Ohio 2023), a product-liability decision that dismissed all claims against all defendants based on lack of personal jurisdiction, preemption, and Twombly.

Claiming that she was injured when an implantable medical device migrated in her body, the plaintiff brought suit in Ohio asserting claims for design defect, failure to warn, and manufacturing defect against four defendants: the device manufacturer, who is located in France; the manufacturer’s parent company; an entity whose role is not identified but appears to be the device’s seller; and that entity’s parent.

The court dismissed the claims against the foreign manufacturer, its parent, and the seller’s parent for lack of personal jurisdiction. (The apparent seller did not contest personal jurisdiction.)

As for the foreign manufacturer, the court held that the plaintiff had failed to produce any evidence that the manufacturer was subject to specific personal jurisdiction under Ohio’s long-arm statute. The plaintiff, said the court, presented no evidence that the manufacturer had transacted business in Ohio; had contracted to supply goods or services in Ohio; had caused tortious injury by an act or omission in Ohio; or had caused tortious injury by an act or omission outside Ohio while regularly doing business in Ohio. 2023 WL 5002818, at *3–4.

The plaintiff claimed that the manufacturer’s parent corporation and the parent corporation of the seller were subject to specific personal jurisdiction because they were alter egos of their respective subsidiaries and subject to jurisdiction on that basis.

Explaining that a parent corporation’s ownership of a subsidiary does not by itself make the subsidiary an alter ego of the parent even when the parent’s and subsidiary’s officers overlap, the court held that it did not have specific personal jurisdiction over the seller’s parent because the plaintiff offered no evidence that would have permitted piercing the subsidiary’s corporate veil. 2023 WL 5002818, at *4–5.

Whether the manufacturer was an alter ego of its parent corporation was, the court found, a slightly closer call given evidence that the parent had assumed some of the manufacturer’s debt upon acquiring it. Nevertheless, the court concluded that the plaintiff had failed to establish that the manufacturer was an alter ego of its parent given the plaintiff’s failure to present any evidence that parent controlled the subsidiary’s daily activities, that the two co-mingled funds, or that they ignored corporate formalities. In any event, said the court, it would not have derivative personal jurisdiction over the parent even if the manufacturer were its alter ego because it lacked personal jurisdiction over the manufacturer. 2023 WL 5002818, at *4–5.

Noting that Ohio has amended its long-arm statute in 2021 to allow the exercise of personal jurisdiction “on any basis consistent with” the U.S. and Ohio constitutions—a provision that has yet to be authoritatively interpreted by either the Ohio supreme court or the Sixth Circuit—the Farson court proceeded to consider whether exercising personal jurisdiction over the manufacturer, its parent, or the seller’s parent was consistent with constitutional due process. Explaining that merely placing a good in the stream of commerce is insufficient, the court held that exercising jurisdiction was not permissible because the plaintiff presented no evidence that the manufacturer or either parent corporation had purposefully availed itself of the privilege of acting in Ohio. 2023 WL 5002818, at *5–7.

All of this goes to show that there still are real limits to specific personal jurisdiction even after the Supreme Court relaxed those limits in Ford Motor Co. v. Montana Eighth Judicial District Court, 141 S. Ct. 1017 (2021), a decision we discussed here.

After concluding that it lacked personal jurisdiction over the manufacturer, the manufacturer’s parent, and the seller’s parent, the court had to decide whether the plaintiff had stated a cognizable claim against the seller, which, as already noted, did not contest jurisdiction. The court held that none of the plaintiff’s claims survived dismissal.

The plaintiff’s design-defect and failure-to-warn claims were preempted, said the court—expressly preempted by 21 U.S.C. § 360k(a) inasmuch as they would impose state-law design and warning requirements different from or in addition to those imposed by the FDA through the PMA process, and impliedly preempted by 21 U.S.C. § 337(a) insofar as they were premised on the manufacturer’s purported failure to supply the FDA accurate data during the PMA process.

As for the plaintiff’s manufacturing-defect claim, the court found that there was “not enough specificity” in the plaintiff’s complaint regarding the purported defect “to determine whether” the state-law duty she posited “paralleled” FDA regulatory requirements. In a holding that is both ironic and an invitation to deliberately vague complaints, the court determined that the very vagueness of plaintiff’s complaint, and the court’s consequent inability to compare the purported federal and state requirements, saved her manufacturing-defect claim from preemption. Nevertheless, the court dismissed the complaint for failure to state a claim, holding that plaintiff’s allegations that the manufacturer’s ill-defined regulatory violations caused her alleged injury “amount to no more than ‘a formulaic recitation of the elements of a cause of action,’” which is insufficient under Twombly. So there you have it. A three-for-three sweep by the defendants on jurisdictional, preemption, and pleading grounds.

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We have lost track of how many times we have written on pelvic mesh cases as they have gone through a number of district courts on remand and occasionally up on appeal to circuit courts.  One theme we have seen play out over and over is that plaintiff lawyers who took on more cases than they could possibly handle employed experts who treated expert reports like assembly lines as depicted in old cartoons, using veritable oversized stamps to affix their “opinions” to report after report.  While these antics and the inevitable requests for leniency may have worked in the MDLs, the remand courts have been far less forgiving.  In other words, they have tended to follow the Federal Rules of Civil Procedure and Federal Rules of Evidence, kicking cases without viable expert opinions on issues on which the plaintiffs bore the burden of proof.  A few months ago, we discussed the Fourth Circuit’s affirmance of the dismissal of just such a case.  The same pattern has been seen in cases filed directly in district courts after the MDLs shut down.

A few compound words might be applied to how plaintiffs like the one whose case the Eighth Circuit addressed in Cantrell v. Coloplast Corp., No. 22-2731, — F.4th –, 2023 WL 5114940 (8th Cir. Aug. 10, 2023).  Gaslighting comes to mind.  When challenged, they tend to misrepresent the history of the case in the hopes that the court will take pity on them.  Backfilling also comes to mind.  They often try to “supplement” an expert report that will never pass muster under Rule 26 or Rule 702 with a report or affidavit that offers what should have been offered in the first place.  Much like someone who claims recent experience shows not only that they are proficient in doing some task but that they have been great at doing it all along—all facts to the contrary—some of these plaintiffs combine gaslighting with backfilling.  Most savvy audiences do not fall for such antics and neither did the District of Minnesota or the Eighth Circuit.  What are we talking about?

The Cantrell plaintiff’s gynecology expert’s timely report included a “three-sentence specific causation analysis” that—wait for it—implicated the defendant’s device as the cause of all of plaintiff’s alleged injuries.  In opposing the exclusion of this opinion, plaintiff offered “a supplemental declaration [from the expert] that included a lengthy specific causation analysis, including a differential diagnosis.”  The district court did not consider the supplement, concluded the initial report did not comply with Rule 26, and struck it.  This cleared the way for summary judgment.  (We know the district court also addressed other experts, but none of them tried to provide the key opinions and they were not addressed on appeal.)

The Eighth Circuit likewise rejected plaintiff’s pleas for special treatment.  The supplemental declaration submitted seven months after the deadline for plaintiff’s expert reports was untimely without any valid excuse.  2023 WL 5114940, *1.  Plaintiff argued that Fed. R. Civ. P. 26(e) allowed her to serve a late report until thirty days before trial as long as she labeled it a “supplement.”  However, 26(e) provides that court orders trump this default deadline and the trial court’s scheduling order did just that.  Id.  It was within the trial court’s discretion to elect not to consider the declaration to help backfill the gynecologist’s expert report.  While conceding that the declaration was not based on information that was unknown or unavailable at the time of the expert report, plaintiff claimed it “merely clarified the methodology” the expert had used.  The gaslighting did not work because the actual report did not mention or describe any methodology.  Id. at *2.

Plaintiff took two more shots at avoiding the consequences of her (in)actions.  Her failure to serve an expert report containing the sort of detailed discussion in the declaration was not harmless because new expert discovery would need to occur if the declaration counted.  The trial court also did not have to consider a remedy short of exclusion because plaintiff never filed a motion asking for relief.  In the absence of a motion, the language of Fed. R. Civ. P. 37(c)(1) (“If a party fails to provide information or identify a witness as required by Rule 26(a) or (e), the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless.”) makes exclusion automatic.  With the expert’s bare-bones report excluded, the plaintiff could not establish a causal relationship between the device and her alleged injuries.  That means summary judgment was appropriate.

When recounting the Eighth Circuit’s analysis, it is hard to imagine a different outcome.  Conclusory expert reports should not satisfy Fed. R. Civ. P. 26(a)(2)(B).  Trying to replace that kind of report with a real one months later because exclusion is imminent should not work absent really good reasons presented in a timely manner.  A plaintiff without an expert to opine on specific causation should lose summary judgment.  Yet, we have seen far too often that plaintiffs in pelvic mesh litigation and other mass torts are afforded the opportunity to backfill if not completely redo expert reports to keep their cases alive.

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Bexis knows to throw us the cases that are a bit off center.  We gleefully gobble up the criminal cases, forfeiture cases, and other weird ones that are not exactly in the heartland of product liability litigation.  We like those cases because they prompt us to think differently, to look at legal disputes with eyes afresh.  There are lessons to be learned in the nooks and crannies. 

We teach a litigation strategy class at Penn Law. One of the big takeaways from the course (we hope) is the importance of assembling compelling stories. Those stories work when they appeal to narratives that people already believe or want to believe.  Think of: a deal’s a deal, David beats Goliath, dollars over lives, taking responsibility for one’s choices, etc.  We also explore ways to conjure up telling, memorable images – concrete details that adhere to the brain pan. It’s hard to beat the example of the criminal indictment that laid out a scheme to dupe regulators by printing out phony financial documents immediately in advance of an inspection. After the printing was done, the defendants formed a circle and threw the documents around to make them look used, then put the documents in the refrigerator to get rid of the printer heat.  That is a story of fraud more persuasive than the most eloquent legal verbiage.  

Todays case, Gilead Sciences, Inc. v. Safe Chain Solutions, LLC, 2023 WL 4991609(E.D.N.Y. July 31, 2023), contains some arresting allegations.  In abstract terms, what we have is a case in which a drug company accuses the defendants of counterfeiting its drugs. That sounds pretty bad, right?  The complaint included claims for violations of the Lanham Act, New York General Business Law, and common law, and it sought monetary and equitable remedies, including an accounting and disgorgement of ill-gotten profits from the manufacture, sale, and distribution of the counterfeit medication. 

Did we mention that the drugs allegedly counterfeited were HIV medications? Or that the counterfeiting ring was said to consist of “kingpins, collectors, suppliers, distributors, and pharmacies”?  The collectors “purchased both empty and full bottles of HIV medication from homeless or drug-addicted patients willing to sell their empty or full bottles of medication for cash.”  That sounds so awful in so many ways. It gets worse. The collectors then “cleaned” the bottles to remove patient labeling, “which often left sticky residue on the repurposed bottles.”  As the kids say, big if true. The plaintiff also alleged that the defendants sold bottles with false pedigrees – records documenting the chain of all the bottle’s sales or transfers going back to the manufacturer. 

At this point, those allegations are just allegations. But the conduct alleged is so brazen and rotten that it is not hard to conceive how they might affect a decision maker’s consideration of the facts or law.  That fact (and we think it is a fact) is a lesson in itself on the power of storytelling. 

The legal issue in the Gilead Sciences decision was whether asset freeze orders against the defendants should remain in place. The plaintiff alleged that the defendants had made off with multi-millions in profits by hawking counterfeit drugs, and convinced the court to impose asset freeze orders against some defendants.  Those asset freeze orders were in the form of temporary restraining orders. The defendants later sought to lift the TROs, while the plaintiff sought to keep the asset freeze orders in place. Keeping the asset freeze orders in place would mean converting the TRO into a preliminary injunction.  The plaintiff bore the burden of making the requisite showing for entry of a preliminary injunction. The court held that the plaintiff met that burden. 

The test for a preliminary injunction is well established. The movant must show (1) a likelihood of success on the merits, (2) absent a preliminary injunction, it will suffer an injury that “is neither remote nor speculative, but actual and imminent, and one that cannot be remedied if a court waits until the end of trial to resolve the harm,” and (3) the balance of equities tips in its favor and an injunction is in the public interest. 

It is interesting, at least for Drug and Device Law nerds, that a defendant argued against likelihood of success based on the theory that the Drug Supply Chain Security Act preempted the plaintiff’s Lanham Act claim. It is equally interesting that the court rejected this argument by drawing a distinction between Buckman preemption (based on the Food Drug and Cosmetic Act “leaving no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions”) and the Drug Supply Chain Act, which contains nothing similar to 21 U.S.C. section 337(a). Resolution of the plaintiff’s Lanham Act claim did “not require this Court to decide how parties may comply with DSCA’s regulatory scheme of pedigrees.”  Rather, the plaintiff’s allegations that the drug pedigrees “contained made-up chains of sale intended to confuse consumers, conceal material differences that would likely be relevant to a consumer’s decision to purchase the drugs, and flout the trademark holder’s quality control standards” are “classic Lanham Act claims.”  So much for preemption. The defendants nit-picked at other aspects of the plaintiff’s claims, but the Gilead Sciences court appraised the plaintiff’s likelihood of success as being sufficiently high. 

The Gilead Sciences court held that a defendant’s long running fraudulent conduct constituted prima facie evidence of irreparable harm. The defendant appeared likely to “dissipate any funds, which would frustrate the enforcement of an equitable award.” The plaintiff had established that the defendant had engaged in a pattern of “fraudulent or evasive conduct so as to justify a preliminary injunction freezing assets to satisfy a potential equitable award.” 

The assessment of the public interest was easy enough. There is no public interest in enabling defendants to escape judgment creditors. Further, while an asset freeze is undoubtedly a hardship, the asset freeze in question was limited. It affected one savings account. The defendant did not demonstrate that a freeze of that one account would drive it out of business. 

There were asset freezes against other defendants and other properties, too.  The court held that the defendants had not established that the particular frozen assets were not proceeds of counterfeiting activities. 

For example, the defendants could not demonstrate that certain frozen assets had not been commingled with ill-gotten gains. Do you see how the effective storytelling (you might even call the allegations inflammatory) managed to shift the burden to the other party? 

There was also some squabbling as to the proper amount of assets that should be subject to the freeze. While the court cut back on some of the assets that would be frozen, for the most part the court held that the plaintiff had met its burden of showing a “reasonable approximation” of counterfeiting proceeds. 

The Gilead Sciences court ended up converting pretty much all the TRO asset freezes into a preliminary injunction asset freeze. The court’s order was without prejudice to a renewed motion by the defendants “if they can show, through documentary proof, that particular assets are not proceeds of counterfeiting activities so as to warrant exemption” of those assets. 

Maybe the defendants can make that case.  But the plaintiff’s excellent storytelling has, at a minimum, put the defendants on the back foot. 

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We have long lamented the apparent relaxation of the Federal Rules of Civil Procedure in multidistrict litigation, and it happened again recently in the Zostavax MDL.  We understand that the purpose of MDLs is to conduct coordinated pretrial proceedings, and we understand an MDL judge’s inclination to take a broader view of case management.  But the MDL statute grants just one extraordinary power—an MDL transferee judge “may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions.”  

The Federal Rules still apply.  Yet, they seem to have given way recently in Zostavax in a way that roundly benefited the plaintiffs.  At issue were 43 cases that one plaintiffs’ attorney filed over the course of a year, but did not serve.  It was undisputed that there was no excuse.  Counsel was “under the impression” that she had served the cases, but apparently the staff member who gave her that impression was mistaken.  The defendant therefore contacted counsel more than one year after the last-filed complaint and asked counsel to provide good cause for the delay, or else the defendant would file motions to dismiss.  Counsel promptly served the complaints—all of them long after Rule 4(m)’s 90-day deadline and some nearly two years after the deadline.  In re Zostavax (Zoster Vaccine Live) Prods. Liab. Litig., No. 2:18-md-02848, 2023 U.S. Dist. LEXIS 138412, at *10-*11 (E.D. Pa. Aug 8, 2023). 

The defendant moved to dismiss, and the plaintiffs requested extensions.  And even though the district court found bluntly that “plaintiffs have not shown good cause why served had not been made,” it still granted extensions.  The district court acknowledged that the plaintiffs had no excuse.  The defendant, however, knew about the filing of all the actions, and its attorneys entered their appearances in each of the cases within days after they were filed.  Under the “totality of the circumstances,” it was the “better course” to allow the actions to proceed.  Id. at *14-*17. 

We have written quite a lot about the Zostavax MDL and have commented favorably on many of its rulings.  That includes entering a Lone Pine order aimed at weeding out worthless claims and entering well-reasoned orders on expert issues that knocked out many others.  Heck, the court’s order enforcing its earlier Lone Pine order was one of our top ten decisions of 2022. 

The order saving these plaintiffs from their failure to serve their complaints is decidedly out of character, and we have a number of beefs with it.  First, this is just one example of MDL judges interpreting federal rules in ways that favors plaintiffs.  We understand that MDL judges today deal with increasingly large numbers of cases, but large numbers do not themselves call for extraordinary relaxation of the rules. 

Second, the district court here faulted the plaintiffs for waiting too long, but it also faulted the defendant.  Why?  Because the defendant knew about the cases, entered appearances in the cases, and still waited up to two years to bring the lack of service to counsel’s attention.  For those of us in California, entering an appearance rings alarm bells because entering a general appearance in California state court waives service of process.  But this is federal court, where there is no such waiver.  As for the purported delay, the defendant had no duty to act, let alone raise the service issue before the court.  Sure, Rule 12 allows defendants to raise insufficient process and insufficient service of process as a defense, but these plaintiffs served no process at all.  We therefore question the district court’s finding that “Plaintiffs have not complied with Rule 4(m), and [the defendant] has not complied with the spirit if not the letter of Rule 12.”  Id. at *16.  The defendant had no duty to act, let alone file a Rule 12 motion to challenge the “sufficiency” of service that was never attempted. 

Third, not only did these plaintiffs get a second chance, most of them appear to have gained a significant advantage.  Thirty-four of the cases were in a group that the district court previously dismissed for lack of proof.  These 34 were not, however, in that order because they had not been served.  Id. at *12-*13.  As a result, this is an instance where the plaintiffs’ dilatory behavior saved their claims:  Instead of having their cases dismissed for lack of proof, they survived by hiding in the weeds, and now they get a second go.  We don’t expect any better outcome, but still. 

The core problem is the district court’s conclusion that “[b]oth sides waited far too long.”  What kind of standard does this erect for defendants?  Parties routinely monitor filings, so every sophisticated defendant, and even some who are not so sophisticated, will be aware of new filings.  Defendants have no duty to prompt their adversaries to serve their complaints, yet this district court seemingly faulted the defendant for failing to do exactly that.  We do not see the equivalence between plaintiffs and defendants on this one. 

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Beginning – at least − with the awful decision in Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448, 465 (W.D. Pa. 2019) (discussed here), plaintiffs seeking to overturn the longstanding Pennsylvania (since the 1940s) prohibition against strict liability in prescription medical product liability litigation have been systematically attacking the precedential weight of Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006) (applying the Pennsylvania prohibition to medical devices) under the false pretense that the plaintiffs in that case were pro se during the appeal.

Not only is that completely irrelevant, since the Superior Court itself made the decision to publish Creazzo as precedential, but it is simply false as a factual matter. The plaintiffs in the Creazzo case were not “pro se.”  That assertion is false, even though plaintiffs have succeeded in misleading several federal district courts – including the court in Schrecengost – on this point.  While we believe that the other side knows or should know that Creazzo was not a pro se appeal, we’re publishing this post to remove all doubt.  

True, if you turn to Creazzo in the Atlantic Reporter you will find, under “attorneys and law firms,” the following:  “Ronnie L. Creazzo, appellants, Pro Se.”  Creazzo, 903 A.2d at 26.  However, that is a publisher’s editorial enhancement and not part of the official Superior Court opinion. The actual Creazzo opinion itself never uses the term “pro se,” nor did the Creazzo slip opinion from the court include any list of counsel. The pro se reference was a mistake by the publishing companies, not the Superior Court. And it is an obvious mistake − since the actual plaintiffs identified in the case caption itself are “Joseph Creazzo and Darlene Creazzo,” not “Ronnie.”  Ronnie Creazzo, Esq. is a Pennsylvania lawyer.  Here is a link to his Martindale-Hubbell lawyer listing.  The inclusion of “pro se” was a transparent error, undoubtedly prompted by the Creazzo plaintiffs/appellants and their (presumably related) counsel sharing the same rather distinctive last name.

Want more proof?  You can access the Creazzo docket sheet (1843 EDA 2005) yourself through the online “case search” function < https://ujsportal.pacourts.us/CaseSearch > of the “Unified Judicial System of Pennsylvania Web Portal” maintained by Administrative Office of the Pennsylvania Courts.  To save readers the trouble, we have downloaded the current Creazzo docket sheet here, but anyone is welcome to confirm that what we say is accurate.  Here is a snip of the relevant portion of the docket sheet:

Note that the Creazzo docket sheet states “Pro Se:     No.”  Note further that the address information for attorney Creazzo accords with what is in Martindale Hubbell (and on similar sites).

The assertions that the other side has repeatedly made about the Creazzo plaintiffs supposedly being “pro se” are not true – period, end of story.  We know the other side reads the blog – so after today we submit any such assertions made in future cases would not merely be false but would presumably become frauds on whatever court to which they might be made.

We ran a search of “Creazzo” and “pro se” in the same paragraph.  It appears that no fewer than four federal court judges have in fact been misled by these misrepresentations – starting with the Honorable Kim Gibson in Schrecengost itself.  Schrecengost stated:

[T]he Pennsylvania Supreme Court would likely decline to adopt Creazzo’s rationale. . . .  There is no indication that the parties presented a full and balanced record of policy considerations to the court in Creazzo.  In fact, the opposite was true. The court acknowledged that the appellants, who were pro se, offered no analysis or authority for a different interpretation of Hahn.

425 F. Supp.3d at 465 (emphasis added).  As discussed above, “the court” in Creazzo “acknowledged” no such thing; it was a publisher’s error.

While Schrecengost was the first court to be bamboozled by an incorrect assertion that the Creazzo plaintiffs were “pro se,” it was not the last.  See also Spear v. Atrium Medical Corp., 621 F. Supp.3d 553, 556 (E.D. Pa. 2022) (“Courts that have not barred strict liability have noted that Creazzo was argued by pro se plaintiffs and therefore unpersuasive”) (Hon. Gerald McHugh); Gross v. Coloplast Corp., 434 F. Supp.3d 245, 250 (E.D. Pa. 2020) (“[t]he pro se plaintiffs in Creazzo do not appear to have litigated the point thoroughly”) (Hon. Michael Baylson); Moultrie v. Coloplast Corp., 2020 WL 1249354, at *9 (Mag. W.D. Pa. March 16, 2020) (describing Schrecengost as “noting that the pro se plaintiffs in Creazzo did not offer a different interpretation”) (Hon. Patricia Dodge).

Thus, plaintiffs in Pennsylvania medical device product liability litigation have successfully misrepresented the purported “pro se” status of Creazzo to at least four Pennsylvania federal judges (three Article III and one Magistrate).  We have no idea how many other times these fallacies have been peddled to other Pennsylvania judges where they did not appear in actual opinions.  We’ve located several.  Most glaringly, in Ebert v. Bard, where (as we discussed here) the Pennsylvania Supreme Court had accepted an appeal on the Creazzo issue, an amicus brief misrepresented Creazzo as “pro se” to the Pennsylvania Supreme Court three times in two paragraphs:

  • “The [Creazzo] plaintiff filed a pro se appeal.”
  • “the pro se plaintiff had not significantly analyzed comment k in its brief”
  • “the pro se plaintiff had not cited authority that comment k did not apply to medical devices”

Brief of Amici Curiae Ella Ebaugh, Suzanne Emmet, the Pennsylvania Association For Justice, and the American Association For Justice, Ebert v. C.R. Bard, 26 EAP 2021 (Pa. filed Sept. 28, 2021) – all quoted material appearing on page 14.

An identical – and identically untrue – discussion of Creazzo as “pro se” appeared in an amicus brief filed by some of the same parties in the Third Circuit in the same case (Ebert came to the Pennsylvania Supreme Court on a certified question).  See Brief of Amici Curiae Ella Ebaugh and Suzanne Emmet, Ebert v. C.R. Bard, 2020 WL 6158889, at *10-11 (3d Cir. filed Oct. 19, 2020).  These same plaintiffs – Ebaugh and Emmet – also made the same mistaken claims that Creazzo was a “pro se” appeal in briefs that they filed with the Pennsylvania Superior Court in their own appeals of the same issue.  See Brief of Appellees Ella Cederberg Ebaugh and Marvin Ebaugh, Ebaugh v. Ethicon, Inc., 2020 Pa. Sup. Ct. Briefs Lexis 4454, at *20-21 (Pa. Super. filed Jan. 6, 2020); Brief of Appellees Suzanne and Michael Emmet, Emmet v. Ethicon Women’s Health & Urology, 2020 Pa. Sup. Ct. Briefs Lexis 2944, at *15-16 (Pa. Super. filed March 11, 2020).  A Westlaw search of federal trial court documents for “Creazzo” within the same paragraph as “pro se” generated another fourteen documents containing the same untrue claims.

These misrepresentations should stop, and if plaintiffs do not voluntarily cease their false statements , defense counsel should call them on it.  See 204 Pa. Code §3.3 (“Candor Toward the Tribunal − (a) A lawyer shall not knowingly: (1) make a false statement of . . . law to a tribunal or fail to correct a false statement of . . . law previously made”).  If they didn’t know before, they know now.

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Like having a first child, when you assume new responsibilities in caring for elderly parents, you get a crash-course education in topics you otherwise never would have thought about.  Have your first child, and you likely will develop a new-found interest—if not firmly-held opinions—on concepts like sleep training and breast feeding.  Take on a role in providing care for elderly parents and you might develop a new-found interest in scintillating topics like compression socks and wound care. 

Which is how we came to know a little bit about hydrogen peroxide.  We were schooled by a wound care physician that hydrogen peroxide is best used as a first aid treatment when a cut or scrape initially happens—but not over time as the wound heals, because it might impede the growth of new skin cells.  At least that was our take-away.  (Note: Don’t take medical advice from lawyers.  We’re not doctors, we just play them on TV.)

Which brings us around to Novotney v. Walgreen Co., — F. Supp. 3d –, 2023 WL 4698149 (N.D. Ill. July 20, 2023) involving, yes, hydrogen peroxide.  In Novotney, the claims stemmed from the labeling of 3% hydrogen peroxide solution as a “first aid antiseptic” to be used for “treatment of minor cuts and abrasions.”  Plaintiff asserted various fraud and breach of warranty claims, and alleged that “hydrogen peroxide is ineffective in treating minor cuts and abrasions because, contrary to popular belief, it does not reduce rates of wound infection… and does more harm than good because it also destroys beneficial bacteria and healthy cells that promote healing.”

Hydrogen peroxide is an FDA-regulated over-the-counter (OTC) drug, so Novotney addressed whether plaintiff’s claims were barred by federal preemption.  And we are pleased to report the court came out the right way.

If you have read this blog for any length of time, you know that OTC drugs have an express preemption provision, 21 U.S.C. § 379r(a), providing that no state may “establish … any requirement … that is different from or in addition to, or that is otherwise not identical with, a requirement” of the Food, Drug, and Cosmetics Act (FDCA).  (You also know that OTC express preemption doesn’t reach product liability claims, but it does cover non-product liability claims seeking economic loss damages.)

Moreover, the FDA established federal labeling for 3% hydrogen peroxide.  As part of a long-history of regulating antimicrobial drug products, the FDA issued a 1991 “tentative final monograph” on First Aid Antiseptic Drug products, and that became final in 2020.  See 21 U.S.C. § 355h(b)(8)(A). 

The defendant noted that its hydrogen peroxide carried almost exactly the labeling the FDA had considered in its First Aid Antiseptic Drug Product monograph, and the court in Novotney agreed.  Because “[t]he gravamen of plaintiff’s claims is that this very labeling, which is regulated by the FDA, is misleading because hydrogen peroxide is not effective as a first aid antiseptic for treatment of minor cuts and abrasions” plaintiff’s claims inherently contemplated that the hydrogen peroxide label should have said something different than the FDA required.  That means express preemption.

Next, the court rejected arguments by the plaintiff that attacked the soundness of the science behind the FDA’s judgment that hydrogen peroxide was appropriately-labeled as a first aid antiseptic for minor cuts and abrasion.  The court found plaintiff’s references irrelevant to the soundness of the FDA’s conclusion, and agreed that preemption applied.  (Indeed, it could have recognized that under implied preemption and Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), state tort claims are inappropriate vehicles for criticizing what the FDA considered in making a regulatory decision or the conclusion it reaches.)

Finally, the court rejected plaintiff’s complaint that the label in question used a word (“treatment”) that wasn’t in the FDA monograph.  “[W]hether the FDA specifically approved the use of the word “treatment” is beside the point. The content of the product’s label as it relates to its safety or effectiveness is a matter of federal law, and by claiming that some other terminology is necessary to ensure that the label is not misleading, plaintiff impermissibly claims that state law imposes requirements that are different from, additional to, or otherwise not identical with, the requirements of the FDCA.”

Rounding out a good decision, the Court dismissed the case with prejudice, finding that any amendment of the complaint would be futile given the OTC express preemption clause. 

Drug & Device Resources

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