Given what we saw in states such as Mississippi, Oklahoma, and Idaho even before the Supreme Court’s  in Dobbs v. Jackson Women’s Health Org., ___ S. Ct. ___, 2022 WL 2276808 (U.S. June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means.  At least one state already has such a law.  La. R.S. §40:962.2.

States can exercise control (for good or ill) over medical practice, including the prohibition of illegal drugs.  Whalen v. Roe, 429 U.S. 589, 597 (1977); Robinson v. California, 370 U.S. 660, 664 (1962).  But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications.  In enacting the FDCA, Congress created the FDA and charged it with “promot[ing] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.”  21 U.S.C. §393(b)(1).  Congress required the FDA to “protect the public health” by making sure that “drugs are safe and effective.”  Id. §393(b)(2)(B).

“Pre-emption is not a matter of semantics.  A State may not evade the pre-emptive force of federal law by resorting to . . . description at odds with the statute’s intended operation and effect.”  Wos v. E.M.A. ex rel. Johnson, 568 U.S. 627, 636 (2013).  On occasion, states have attempted to prohibit sale and/or use of non-abortion-related FDA-approved products, but with one exception, these efforts have not resulted in litigation.  See Lars Noah, “State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products,” 2016 Mich. St. L. Rev. 1, 16-22 (2016) (collecting examples).

However, one state’s attempt to prohibit doctors in that state from prescribing an FDA-approved opioid did produce interesting precedent (which we previously discussed here and here).  Massachusetts was enjoined in Zogenix, Inc. v. Patrick, 2014 WL 1454696 (D. Mass. April 15, 2014) (“Zogenix I”), and Zogenix, Inc. v. Patrick, 2014 WL 3339610 (D. Mass. July 8, 2014) (“Zogenix II”), vacated in part on other grounds, 2014 WL 4273251 (D. Mass. Aug. 28, 2014) (after prohibition rescinded) (“Zogenix III”).  The state (technically, a commonwealth) first tried an outright ban − allowing only an “abuse-resistant formulation” that the FDA had not approved − with the governor “empower[ing]” the public health department “to immediately prohibit the prescribing and dispensing of” the plaintiff manufacturer’s drug.  Zogenix I, 2014 WL 1454696, at *1-2.  The ban was preempted.  “If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health.”  Id. at *2

The state then took another tack, enacting onerous “regulations limiting the prescribing and handling of” the drug that amounted to a “de facto ban.”  Zogenix II, 2014 WL 3339610, at *1, 3.  The disputed regulations ostensibly regulated how health care providers and pharmacists could prescribe and/or dispense the targeted drug.  They required that the prescriber “certify” in a particular for of writing that “other pain management treatments have failed” and they limited its distribution “only” to pharmacists.  Id. at *2.  The plaintiff manufacturer argued, and the court agreed, that the state’s regulations were so restrictive that they effectively “banned [the drug’s] prescribing, ordering, dispensing, or administration.”  Id. at *1.

Logically, that state action contradicted the FDA’s determination, essential to the FDA’s approval of that (or practically any) product, that the drug’s benefits outweighed its risks.  The state could not interpose its “no,” where the FDA, exercising federal power, had said “yes.”  This logical contradiction posed a significant “obstacle” to the exercise of the FDA’s authority to approve the products it regulates for marketing.  “What is a sufficient obstacle is a matter of judgment, to be informed by examining the federal statute as a whole and identifying its purpose and intended effects.”  Id. at *2 (quoting Crosby v. National Foreign Trade Council, 530 U.S. 363, 373 (2000)).  The effective state-law ban of an FDA-approved drug necessarily “frustrated” the FDCA’s statutory scheme, requiring that the state’s power “must yield to the regulation of Congress.”  Zogenix II, 2014 WL 4273251, at *2 (quoting Savage v. Jones, 225 U.S. 501, 533 (1912)).

  • “to ‘protect the public health’ by ensuring that ‘drugs are safe and effective’”;
  • to require that “[t]he FDA must approve new drugs before they are introduced to the market”;
  • to create “a structured risk-benefit assessment framework” administered by the FDA;
  • to preclude approval of any new drug “if [the FDA] concludes the drug is unsafe, or if there is insufficient information from which to determine whether the drug is safe”; and
  • to “mak[e] available to the public” new drugs that “pass[] the [FDA’s] benefit-risk assessment” and thus “promote[] the public health.”

Id. at *3 (various statutory citations omitted).

The state continued to run afoul of preemption in Zogenix II by “trying to make scarce or altogether unavailable a drug that the FDA, by approving it, has said should be available.”  Id.  Notwithstanding a state’s undisputed police power “to regulate the administration of drugs by the health professions,” no state may “exercise those powers in a way that is inconsistent with federal law.”  Id. at *5.  While states had considerable power to regulate the use of opioids as controlled substances, they could not exercise that power to bar the use of an FDA approved drug altogether through the chilling effect of what Zogenix II found to be a “vague” and “uncertain” regulatory scheme.  The state “Defendants may interpret and enforce the challenged regulations in a way that obstructs the FDCA’s objectives,” however, they may also act more liberally.  Id. at *5.

Finally, in Zogenix III, after the state rescinded that set of regulations and “promulgated new regulations” that “omit[ted] the conflicting, troublesome language” that amounted to a ban by other means, the new regulations “no longer offend[ed] the Supremacy Clause of the United States Constitution.”  2014 WL 4273251, at *1, 3.  “The obstacle − mandatory preliminary prescribing of other [drugs] − has now been removed.”  Id. at *3.

While the Zogenix litigation invoked so-called “purposes and objectives” preemption (see our discussion here), additional support for preemption of state-law bans of FDA-approved drugs under the rubric of impossibility preemption is found in product liability decisions that are the Blog’s primary focus.  An absolute prohibition on the marketing of an FDA-approved product is the most extreme form of a purported state-law “stop selling” duty that the United States Supreme Court held preempted in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  “Stop-selling” claims are simply:

incompatible with our pre-emption jurisprudence.  Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether…. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless.

Id. at 488 (citation and quotation marks omitted).  Importantly, Bartlett recognized that “statutory ‘mandate[s]’ do precisely the same thing” as tort suits in that they “require a manufacturer to choose between leaving the market and accepting the consequences of its actions.”  Id. at 491.  Bartlett went on to analogize imposition of stop-selling tort liability to a state’s “directly prohibiting the product’s sale.”  Id. at 489 n.5.  Even one of the two dissents in Bartlett expressed discomfort with stop selling claims.

The FDA is responsible for administering the relevant federal statutes.  And the question of pre-emption may call for considerable drug-related expertise.  Indeed, one might infer that, the more medically valuable the drug, the less likely Congress intended to permit a State to drive it from the marketplace.

Id. at 494 (but finding conflicting FDA positions on the particular issue before the Court) (Breyer & Kagan JJ., dissenting).

Thus, “‘an outright ban’ cannot be a viable alternative to sustain a [state-law] claim.”  Trisvan v. Heyman, 305 F. Supp.3d 381, 405 (E.D.N.Y. 2018).  “Insofar as the plaintiffs’ . . . suggest[] that the defendants should never have sold the FDA-approved formulation of [their drug], such claims have been explicitly repudiated by the Supreme Court.”  Utts v. Bristol-Myers Squibb Co., 226 F. Supp.3d 166, 186 (S.D.N.Y. 2016).  Likewise, in Silver v. Bayer Healthcare Pharmaceuticals, Inc., 2021 WL 4472857 (D.S.C. Sept. 30, 2021), the plaintiff’s claim that the defendant’s drug “should have been banned . . . constitutes a ‘stop-selling’ theory, which courts have consistently found to be preempted by federal law.”  Id. at *4.

Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), similarly preempted a state-law claim “that defendants should never have sold the[ir] FDA-approved [product] in the first place” was preempted under Bartlett as another variant of a “‘stop-selling’ rationale.”  Id. at 300.  Similarly reflecting Bartlett’s holding, preemption of demands based on state law that drug/device manufacturers refrain from selling their FDA-approved products is widespread.  The court in Gross v. Pfizer, Inc., 825 F. Supp.2d 654 (D. Md. 2011), aff’d, 741 F.3d 470 (4th Cir. 2014), was “aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce.”  Id. at 659.  “Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.”  Id.  Likewise, an appellate court in California “conclude[d] that plaintiff’s design defect claim that defendants should have withdrawn [the drug] from the market is preempted by the impossibility preemption analysis . . . in Bartlett.”  Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127, 158 (Cal. App. 2017).

In Mayor & City Council of Baltimore v. GlaxoSmithKline, LLC, 2022 WL 537004 (Md. Cir. Jan. 28, 2022), a municipality sought to prohibit the marketing of an entire class of drugs because they were allegedly “inherently dangerous even when taken as directed and when appropriately stored.”  Id. at *4.  That claim was “impliedly preempted” because it was grounded on the contention that the defendants “would violate their duty under [state] law by simply marketing [their drugs] in its FDA-approved form and with its FDA-approved label.  In other words, they would have been required to stop selling” their products.  Id.

Numerous other courts reject allegations that state law can prohibit the sale of FDA-approved drugs.  Evans v. Gilead Sciences, Inc., 2020 WL 5189995, at *9-10 (D. Haw. Aug. 31, 2020) (quoting and following Bartlett); Javens v. GE Healthcare, Inc., 2020 WL 2783581, at *6 (Mag. D. Del. May 29, 2020) (claim that defendants should have marketed a different product was “clearly preempted by federal law), adopted, 2020 WL 7051642 (D. Del. June 18, 2020); Mahnke v. Bayer Corp., 2019 WL 8621437 at *5 (C.D. Cal. Dec. 10, 2019) (quoting and following Bartlett); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 185 F. Supp.3d 761, 771 (D.S.C. 2016) (“any claims that Defendant should have simply stopped selling the drug to women . . . is preempted”); Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 678 (S.D.N.Y. 2017) (claims that “challenge[] the FDA’s approval of . . . [an] indication . . . are preempted”) (quoting 73 Fed. Reg. 49603, 49606 (FDA Aug. 22, 2008)), aff’d, 919 F.3d 699 (2d Cir. 2019); In re Fosamax Products Liability Litigation, 965 F. Supp.2d 413, 420 (S.D.N.Y. 2013) (Bartlett “preempted the possibility of [state law] claims based on a [drug manufacturer’s] failure to stop selling the product”).  But see Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528, 537-38 (6th Cir. 1993) (pre-Bartlett decision allowing what was essentially a stop selling claim) (applying Kentucky law).

A couple of other cases we’ve blogged about also bear on state-law attempts to ban FDA-approved products.  First, in a non-product liability application of Bartlett, the court in Exela Pharma Sciences, LLC v. Sandoz, Inc., 486 F. Supp.3d 1001 (W.D.N.C. 2020), held that a competitor could not attack the FDA’s discretion to allow a product on the market on an emergency basis through a “memorandum of discretion.”  Id. at 1008.  The Excela decision analogized the plaintiff’s attack on the legality of the defendant’s FDA-approved importation of its product to a Bartlett-style “stop-selling” claim:

[T]he FDA issued a Memorandum . . . allowing the Defendant temporary permission to import and sell its [drug] product.  Notwithstanding the Defendant’s permission from the FDA, a viable [trade practices] claim related to the import and sale of [that] product would have nonetheless forced the Defendant “to leave the market or accept tort liability.”  This is precisely the type of claim that . . . must be preempted.

Id. at 1015 (quoting Drager v. PLIVA USA, Inc., 741 F.3d 470, 479 (4th Cir. 2014)).  Consequently, any claim “assert[ing] that the only way to comply with state law would have been for the Defendant to leave the market notwithstanding the Defendant’s compliance with the FDA’s directives” is preempted.  Id.

Finally, for historic reasons we discussed here, the FDA, for a long time (this now seems to be changing) allowed the marketing and sale of homeopathic products despite considerable questions about their efficacy.  In 2015, private plaintiffs, wielding state-law causes of action, attempted to enjoin the continued sale of homeopathic products market despite the FDA allowing them to be sold.  Herazo v. Whole Foods Market, Inc., 2015 WL 4514510 (S.D. Fla. July 24, 2015).  That injunctive claim was impliedly preempted.

Plaintiffs’ suit seeking to change the labeling requirements of Defendant’s homeopathic medication conflicts with federal policy and should be impliedly preempted. . . .  [T]he Court additionally finds that allowing the claim for injunctive relief to go forward would undermine the purpose for which Congress enacted the uniformity provision and thwart the Food and Drug Administration’s ability to carry out its oversight of marketing of homeopathic products.

Id. at *5.

As our past posts indicate, we’ve always been interested in the preemption of state-law “stop selling” claims.  But before, that had been in our capacity as defense counsel in prescription medical product liability litigation.  Post-Dobbs, it’s personal as well.  Because, as this post makes crystal clear, FDCA-based preemption can be a pro-choice position.

This post is from the non-Dechert side of the blog.

Before we get to today’s case, we fondly tip our hat to the Westminster Kennel Club Dog Show, held (and televised) last week.  Regular readers know how much we love this annual event and also may recall that our “heart breed” is the Standard Poodle.  (We actually had a probable future family member competing – “Joel,” a gorgeous grand champion white standard shown in cords.) Ultimately, the purple Best in Show Rosette was awarded to Trumpet the Bloodhound, marking the first time that breed has taken the top honor at Westminster.  By all accounts, Trumpet is a spectacular representative of his venerable breed, and we are excited about his historic win.

We also are happy about the result in today’s case, Africano v. Atrium Med. Corp., 2022 U.S. Dist. LEXIS 100428 (N.D. Ill. June 6, 2022), in which the court denied the plaintiff’s motion for new trial and affirmed multiple helpful rulings on the admissibility and inadmissibility of FDA-related evidence.  We have blogged about Africano three times before.  The plaintiff asserted claims for failure to warn and manufacturing defect, alleging that the defendant’s allegedly unsterile hernia mesh injured him when it was implanted in him to repair his inguinal hernia.  At trial, as we reported, the jury found for the defendant on both claims.

The plaintiff moved for a new trial pursuant to Fed. R. Civ. P. 59, arguing that the trial court erred in excluding several pieces of evidence.  First, the plaintiff argued that the court should have admitted evidence of a government complaint and consent decree against the defendant.  The consent decree shut down one of the defendant’s manufacturing plants until the defendant came into compliance with certain FDCA manufacturing regulations.  Before trial, the court granted the defendant’s motion in limine to exclude both documents, holding that “both constituted inadmissible hearsay; that the complaint did not fall under the public records exception to hearsay; that the consent decree did not constitute non-hearsay evidence as a statement of a party opponent; and that [Fed R. Evid.] 408 also rendered the consent decree inadmissible to the extent [that the plaintiff] offered it to prove the truth of the matters contained therein.”  Africano, 2022 U.S. Dist. LEXIS 100428 at *4-5 (citation omitted).

On the eve of trial, the plaintiff moved for reconsideration of the exclusion of the FDA complaint, arguing that it intended “to use the complaint for the non-hearsay purpose of impeaching [the defendant’s] argument” that it had cured deficiencies in its sterilization process.  The court denied the motion, finding that the complaint did not address the sterilization process in question but “broadly alleged regulatory violations that were not facially related to the” sterilization process,   id. at *5, so could not be used be used for impeachment as the plaintiff described.  The court also found that the complaint was inadmissible under Rules 401 and 403 because it related to an inspection that postdated the manufacture of the plaintiff’s hernia mesh, so “the risk of prejudice and confusion outweighed the complaint’s limited probative value.”  Id. at *6 (citation omitted).

In his motion for a new trial, the plaintiff argued that the complaint was not hearsay because the plaintiff “would not have offered it to prove that the [sterilization process] was not adequate, only that the FDA had not found that it was.”  Id. at *7 (citation omitted).  The court held:

This argument, as Defendant points out, is pure sophistry.  The only relevance of the FDA’s view of a process being inadequate is to show that the process actually is inadequate.  Plaintiff therefore sought to admit the complaint for the truth of the matters purportedly asserted therein – that Defendant’s sterilization validation was inadequate.  This runs headlong into the rule against hearsay.

Id., at *7-8.   Moreover, contrary to the plaintiff’s argument that the complaint was relevant because it suggested that the defendant’s validation of its sterilization process was not adequate, the court reiterated that the complaint “did not say anything about whether the sterilization validation was inadequate.”  Rather, it alleged “broad regulatory violations that, on their face, [did] not specifically related to the sterilization validation process that concerned” the plaintiff’s hernia mesh product.  Id. at *8.   Finally, the complaint did not qualify for the public records exception to the hearsay rule because it contained “mere allegations, not factual findings.”  Id. 

The plaintiff also argued that the court erred in excluding two observations from an FDA Warning Letter the defendant received.  The court had allowed the plaintiff to introduce the first page of the warning letter and the first of six observations, which, it found, was relevant to the case because it addressed the adequacy of the defendant’s validation of its sterilization process.  In his motion for a new trial, the plaintiff challenged the exclusion of the second and third observations.  Observation 2 concerned a different mesh than the mesh implanted in the plaintiff, and Observation 3 concerned foreign material, including hair, found in the defendant’s sterile medical devices.  The court found that the plaintiff had not met his burden of showing that these incidents “occurred under substantially similar circumstances [to] those at issue in this case;” thus, he “failed to show the probative value of these other incidents.”  Id. at *11 (citation omitted).   As such, “the potential for these unrelated incidents to confuse and mislead the jury substantially outweighed their probative value.”  Id.

The court also rejected the plaintiff’s argument that the court’s exclusion of Observations 2 and 3 “prevented the jury from considering the entirety” of the defendant’s failure to “address basic contamination prevention.”  Id. (internal punctuation and citation omitted).   To the contrary, the court emphasized, the jury was permitted to see the unredacted first page of the warning letter, which set forth the defendant’s failure to conform to the relevant regulatory requirements.  Finally, the court rejected the plaintiff’s argument that the exclusion of Observations 2 and 3 impaired his ability to cross-examine the defendant’s experts, emphasizing, again, that the excluded observations concerned observations “having nothing to do with the sterilization procedures relating to the . . . mesh product” at issue in the case.   The court concluded,

After considering [Plaintiff’s] arguments, this Court determines a new trial is unwarranted.   Plaintiff has not demonstrated that any of this Court’s evidentiary decisions constitutes error, much less the kind of error that had a substantial and injurious effect on the jury’s verdict.  Accordingly, this Court denies Plaintiff’s motion for a new trial.

Id. at *15 (citation omitted).   We really like this opinion.   Complicated evidentiary issues like these are a quagmire, and it is too easy for courts to punt tough threshold admissibility questions in favor of juries’ “weight of the evidence” assessments.   We agree with the court’s pretrial rulings and applaud its refusal to reconsider them.

We’ll talk to you soon, hopefully with poodle news to share.  In the meantime, stay safe out there.

Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues.  Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon.  Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility.  Id. at *1.

The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  It wasn’t.  Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.”  Id. at *2.  Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 

Continue Reading FDCA-Based Negligence Per Se & Informed Consent Don’t Mix

We’re pragmatic geeks. That means we love personal-jurisdiction issues. This year alone we’ve reported on personal-jurisdiction cases here, here, and here. And then yesterday we did it again. Although the decision we discussed yesterday, English v. Avon Products, Inc., — N.Y.S.3d —-, 2022 WL 1787160 (N.Y. App. 2022), was unfortunate in its ultimate resolution of the jurisdictional question, we did note one positive aspect of the court’s analysis—its recognition that jurisdiction under New York’s long-arm statute “may not be based upon” a company’s “business dealings to acquire raw [material] from … a New York [supplier].” Id. at *3.

Today’s case, Greenwood v. Arthrex, Inc.., 2022 WL 2117763 (W.D.N.Y. June 13, 2022), which has a happier ending than English, looks at the issue from the other direction. The question in Greenwood was whether the court had personal jurisdiction over an out-of-state component supplier whose product was incorporated in an allegedly defective medical device sold and used in New York.

The court found that there was no jurisdiction over the component supplier.

According to the court, the plaintiff had neither alleged nor “shown” through affidavits or otherwise “that [the component supplier] availed itself of New York law such that it could anticipate being haled before New York courts.” 2022 WL 2117763, at *8. In particular, said the court, the plaintiff did not allege or show that the supplier “knew or should have known that its parts were destined for New York or that [the supplier] attempted to reach the New York market.” Id.

The court placed particular emphasis on the fact that the plaintiff did not allege or show “a working relationship” between the supplier and the device manufacturer.” 2022 WL 2117763, at *8. That, said the court, distinguished the facts in front of it from those in McDonough v. Cycling Sports Grp., Inc., 392 F. Supp. 3d 320, 329 (W.D.N.Y. 2019), where the component supplier was alleged to have  “worked closely” with the end-product manufacturer “to design and manufacture” the component. Id.

While the facts alleged and partially shown in McDonough were sufficient to get the plaintiff there limited jurisdictional discovery so that she could try to present evidence in opposition to the component supplier’s motion for summary judgment, the Greenwood court denied the plaintiff jurisdictional discovery, finding that her “barebone allegations are not legally sufficient to allege personal jurisdiction” and that she did supplement her conclusory allegations with “evidence to support” them. 2022 WL 2117763, at *9.

Component suppliers take note.

This is called the Drug and Device Law blog, but every once in a while we discuss cases that involve neither drugs nor devices. Usually that is because those cases offer lessons applicable in our subject matter area. Or – and this is a confession – sometimes those cases are simply fun. For example, we will always be suckers for criminal cases due to our stint as a federal prosecutor.

There is no doubt that there is something different about drug and device cases. Despite plaintiff claims about negligence (e.g., failure to test) or fraud or the usual ‘dollars over lives’ canard, the truth is that drug and device companies are careful, conscientious, and heavily regulated. You cannot say that about all tort defendants.

A long time ago (though not as long ago as our AUSA days), we defended a nutraceutical company. The claims in that particular case were utterly bogus. Still, we learned that the FDA regulated nutraceuticals with a somewhat light touch. Compared to the drug and device regulatory environment, nutraceuticals inhabit the Wild West. We heard about a company that hawked an herbal diet supplement via before-and-after pictures. The before picture used a model who was pregnant and the after was taken after she had given birth, so, yes, she looked considerably slimmer in the after.

That is not to say the herbal supplement biz was all hokum. We can recall one particular client who knew some very real things about supplements and their effects on the human body. He had worked up a hearty hatred for the plaintiff lawyer and the deposition process. Before his deposition, he imbibed a supplement concoction with the aim of creating an, er, malodorous event. It worked. He unleashed a double-barreled (mouth and south) crop-dusting gas attack in the conference room. The deposition did not last long. Who says supplements don’t work?

We’ve also worked on some asbestos cases. They are governed by an almost entirely different set of legal practices and procedures. Good luck getting timely dispositive motion rulings. Good luck, also, in dealing with plaintiff lawyers who do even a minimum of homework in selecting defendants. To be sure, there are diligent asbestos plaintiff lawyers out there. We’ve opposed some of the best. But too many plaintiff asbestos lawyers simply sue every defendant in sight, with no effort to identify plausible exposures or specific product usage. The complaints are often sloppy at best. Moreover, we have seen some plaintiff asbestos lawyers who haul 30-40 far-flung defendants into a jurisdiction bearing no real connection to those defendants or the case, save for being the home court of the plaintiff firm. And then those plaintiff lawyers act offended when a defendant raises the issue of personal jurisdiction. The Bauman and BMS cases arrive as unpleasant wake-up calls for those lawyers. Few things have affected tort law more than recent SCOTUS personal jurisdiction doctrine.

That brings us to today’s case, English v. Avon Products, Inc., 2022 WL 1787160 (N.Y. App. June 2, 2022). In English, the plaintiff claimed that she developed peritoneal mesothelioma from her use of talcum powder that allegedly contained asbestos. The plaintiff was a resident of Texas. The defendant was a New Jersey corporation. Despite the fact that the New York Giants and New York Jets play in New Jersey, New York and New Jersey are two different states. The talcum powder was never manufactured in New York. The plaintiff did not purchase the powder in New York. Thus, the defendant seems to have had strong grounds in filing its motion to dismiss the complaint based on lack of personal jurisdiction.

We are sorry to report that the defendant in English lost the motion at both the trial court and appellate levels. We do not agree with that outcome. It seems to us that there was flimsy support for personal jurisdiction in New York over the New Jersey defendant. What was that support? The plaintiff had been a flight attendant from 1966 to 1999. She regularly flew into New York two to four times per month. She packed the talcum powder in her luggage and brought it with her to New York. Meanwhile, the defendant marketed its talcum powder nationally, including in New York. It also maintained a marketing office in New York, as well as its International Division headquarters.

There was obviously no general personal jurisdiction over the defendant in English. The issue was whether there was specific personal jurisdiction. The English court leaned on the SCOTUS (unfortunate) holding in the Ford Motor Co. case that there need not be a causal relationship between the defendant’s in-state activities and the claim asserted. Rather, the English court reasoned that the defendant “engaged in a persistent course of conduct of transacting business in New York” in the years that the plaintiff used the product, including using it in New York. Though the English court cited BMS, almost all of its reasoning rested on pre-BMS precedent. Because much of the language in those precedents was not only out of date but also at odds with BMS, we think the English decision is simply wrong.

But there is one part of the English decision that is not wrong. The title of this post is a spoiler. The English court agreed with the defendant that jurisdiction over it may not be based upon its business dealings to acquire raw material from a company in New York. That is an important ruling, because we have seen several plaintiff lawyers attempt to premise personal jurisdiction in the lawyers’ home court on the foreign defendant’s acquisition of raw materials in that jurisdiction. Despite its bad bit, at least English shuts down that argument. And as for the bad bit of English, it shouldn’t be hard to distinguish it based on the unusual fact scenario of the flight attendant plaintiff regularly using the product in the jurisdiction.

We hope our regular DDL readers are not bothered by our discussion of the slightly broken English case. It is not about drugs or medical devices, but it might be of use to our fellow defense hacks some day.

Otherwise, we have decided that we should be on the pardon list, if that is still in the works.

Perhaps not as menacing as Lions and Tigers and Bears (Oh my) – but feasible, adequate, and effective proved to be too much for plaintiff in Davis v. Johnson & Johnson, 2022 WL 2115075 (Jun. 9, 2022).

It is a remanded pelvic mesh case.  On defendant’s motion to exclude certain testimony by plaintiff’s expert, most of the court’s rulings were wait and see at trial with some admonitions that plaintiff’s expert should not stray from his reports or attempt to introduce evidence that was excluded by the MDL court.  But, on the question of whether plaintiff’s expert could offer his “alternative design” theories, the court squashed that testimony like a house landed on it.

Kansas follows a “consumer expectation” test for design defect.  That means, a plaintiff must show that a product is both defective and dangerous “to an extent beyond that which would be contemplated by the ordinary consumer” with ordinary knowledge.  Id. at *3.   Evidence of an alternative design is not required by Kansas’s consumer expectation test.  However, if plaintiff seeks to introduce evidence of an alternative design, that evidence must show “that the alternative design is feasible, adequate, and effective.”  Id. at *2.

Defendant’s first argument as to all of plaintiff’s expert’s offered alternative designs was that they were ipse dixit given the lack of support in his report.  In plaintiff’s expert’s opinion, plaintiff’s injuries were caused by the use of polypropylene mesh.  Therefore, he leaps to the conclusion that alternatives that do not use polypropylene are safer.  Id.  It does not follow, absent any explanation, that other products without polypropylene are feasible, adequate or effective alternative designs.  Due the analytical gap, plaintiff’s expert’s alternative design testimony was excluded.

But the court did not stop there.  Plaintiff’s expert’s first alternative design was actually an alternative procedure – native tissue repair.  The court cited numerous other decisions rejecting alternative procedures as alternative designs to the product at issue.  Id. at *3.  Plaintiff argued those cases were inapposite because alternative treatment evidence was part of the consumer expectations analysis.  Not so in Kansas where the Kansas Supreme Court has said that “a guide” in consumer expectations cases may be to look at, among other things, “the mechanical feasibility of a safer alternative design, not alternative treatments or products.”  Id.  The court went on to say that evidence of alternative procedures is of “dubious relevance” to a design-defect claim.  Id.  But, it left the door every so slightly ajar if plaintiff could first establish relevance in some way.  About as likely as a talking scarecrow without a brain.

Finally, plaintiff’s expert offered as an alternative a product made of PVDF.  PVDF, however, was not approved in the United States at the time of plaintiff’s surgery.  Id. at *4.  Plaintiff attempted to rely on the fact that PVDF existed at the time, but lack of FDA clearance was a bar to feasibility and therefore a bar to its use as evidence of an alternative design.  Id. at *4-5.

Plaintiff may wish she wasn’t in Kansas anymore, but that’s where she is and that means no admissible evidence on alternative design.

We have written a number of posts about pelvic mesh cases over the years.  Some of us have also worked on a number of cases.  At this point, many cases have gone from MDL to local district court to judgment to appeal.  Over time, the tide seems to have turned.  That could be because the local courts have taken a different approach than the MDLs did, because it is hard to prove a design defect when your experts criticize every device in the class, or because the prescribing doctors in later cases were aware of the risks.  In any event, we have not tired of writing about pelvic mesh wins and we still find some new twists.

Donaldson v. Johnson & Johnson, __ F.4th __, 2022 WL 2145276 (7th Cir. June 15, 2022), affirmed summary judgment for the manufacturer in a case alleging injuries from a stress urinary incontinence sling and pelvic organ prolapse mesh.  We are not discussing it just because the defendant won below and on appeal.  Or because the win below was in a district with a reputation for being plaintiff-friendly.  It also played out some recurring themes in these cases and presented a quirk of Illinois law we have not discussed much previously.

The pre-litigation facts of Donaldson are fairly simple:  Implant in 2010 of the two devices and treatment in 2014 for “injuries resulting from erosion of the mesh into her bladder, vagina and adjacent tissues, causing scarring, bladder stones and abdominal pain, among other problems.”  Her implanter gave testimony that would have ended her warnings claim—he was aware of all the relevant risks and stood by his decisions—but she dropped it.  Instead, she proceeded under a design defect theory predicated on “non-specific defects,” which is that Illinois quirk we referenced.  Under a case called Tweedy, in certain circumstances that sound quite a bit like res ipsa loquitur, a design defect claim can be established without identifying a specific defect.

We pause here to return to pelvic mesh litigation in general.  One of the two central allegations of the plaintiffs has been that the synthetic mesh devices are defective because, well, they are made of mesh.  That may be dressed up with allegations about pore size, alleged in vivo degradation, and other things, but using permanent synthetic mesh in a soft tissue repair near sensitive organs (especially if placed through the vaginal wall) is a bad idea, or so plaintiffs have alleged.  If, for instance, a plaintiff alleged vaginal erosion and her experts agreed that every mesh device sold in the United States for the same indication had a similar risk of vaginal erosion, then plaintiff was not really alleging a specific defect with the device.  The classic design defect claim requires proof that changing some aspect of the product, while retaining its basic nature and efficacy/usefulness, would have avoided the alleged injury.  You cannot claim a permanent synthetic pelvic mesh would have been safer if it had not been a permanent synthetic pelvic mesh any more than you can claim a car’s brakes would have been safer if the car had been a horse-drawn carriage.  Over time, the courts have caught on to this and more and more design claims have failed because plaintiffs cannot identify a specific design defect that proximately caused the plaintiff’s injuries.

Illinois, though, has this Tweedy line of cases that allows claims for design defect without identifying a specific defect and the plaintiff in Nicholson put all her eggs in the Tweedy basket.  She also built her case around Dr. Nayak, a treating physician who signed an attorney-drafted affidavit that offered a bunch of boilerplate allegations about both devices at issue in the case and that the devices caused all of plaintiff’s injuries.  When deposed, however, he retracted just about every opinion, except that he kept an opinion that the pelvic organ prolapse mesh caused certain injuries (even though he did not even perform prolapse repair surgeries).  (The ins-and-outs of the affidavit and retractions in deposition are discussed at length in the opinion and we can imagine the joy and angst of the counsel during the deposition.)  It appears that the plaintiff named no experts other than Dr. Nayak and, when the defendant moved for summary judgment, the plaintiff relied on Dr. Nayak’s pre-deposition affidavit in opposition.  We do not know why Dr. Nayak signed the affidavit with all those opinions he could not support or why plaintiff had no experts even after Dr. Nayak tanked, but we do have some educated and jaundiced guesses.  The district court largely disregarded the affidavit, relied on the testimony, and ruled that the Tweedy doctrine did not apply in cases involving complex medical devices.  That meant summary judgment.

The Seventh Circuit took a different route to get to the same result.  First, it found no abuse of discretion in the district court’s striking the affidavit.  The repeated contradiction in deposition and the circumstances of the affidavit were enough to invoke the sham affidavit rule or, as we have called it, the reverse sham affidavit rule.  Id. at *3  Next up was whether the Tweedy doctrine could be applied in cases involving complex medical devices.  The court ruled that it could because it had been before, including in a case we discussed here.  Because this is purely a matter of state law, we will not dwell on it, but this is a bad exception to the usual design defect requirements in Illinois and elsewhere, which require a specific defect and proof of proximate cause.  Res ipsa does not make sense in cases against manufacturers of implantable medical devices.  They do not implant themselves, are not under the manufacturer’s control when implanted, and existing product liability causes of action are sufficient for relief for plaintiffs who have the facts and expert testimony to sustain them.  It is not like a malpractice claim over a sponge left in a patient during surgery.  We have railed against res ipsa in mesh and other device cases before.  We will save some breath on it here, because it did not matter to the result.

The criteria for the Illinois exception are:

[T]he product failed to perform as expected, in light of its nature and intended function, and that the product was not being used abnormally and that there were no reasonable secondary causes of the failure.

Id. at *4.  When we said Dr. Nayak’s affidavit contained boilerplate, we mean that it repeated these criteria with some words swapped in and maybe some detail added.  Once the affidavit was out of the picture, the court’s conclusion that the plaintiff had to prove these criteria through expert testimony meant the focus was on Dr. Nayak’s deposition testimony.  Id. at **5-6.  That was a problem for plaintiff.

His testimony could not carry plaintiff’s burden as to eliminating “reasonable secondary causes” of each of the claimed injuries.  Obviously, he did not implicate the sling at all.  His testimony on the prolapse mesh was not much stronger.  As to vaginal erosion, Dr. Nayak agreed with defendant’s expert that vaginal atrophy could be a cause (after being informed of the atrophy in deposition).  Id.at *6.  He also agreed an intervening surgical procedure to repair posterior prolapse (whereas the prior surgery was for the anterior compartment) could be the plaintiff’s pelvic pain.  His opinion that it was possible—not likely—that the defendant’s prolapse mesh caused the plaintiff’s bladder erosion and stones was not enough to rule out other causes, especially where he had reviewed a small subset of the medical records.  Id. at *7.

He also could not establish that the prolapse mesh “failed to perform in the manner to be expected in light of its nature and intended function.”  First of all, the anterior prolapse remained repaired after the implant.  Second, as someone who did not perform prolapse repairs, he could not weigh in on the risk-profile of the defendant’s device versus “other surgical options.”  Id.  (We think this is an overly generous framing of the question, because the comparison should be to other then-available mesh devices for anterior prolapse repair not to all options for repair of anterior prolapse.)  That added up to an affirmance of summary judgment even though the Tweedy doctrine applied.  The erstwhile expert—or at least overly generous affiant—could not get plaintiff to clear two relatively low bars.  For states where no res ipsa end run on design defect is available, proof like this would not have a chance to get the plaintiff past summary judgment.

 

An explanted medical device is an interesting thing.  It was designed and made to reside within the human body, and it was implanted for the purpose of saving or improving life, even if only cosmetically.  Sometimes it has to be removed, often by design and under the applicable standards of care.  Take for example retrievable vein filters and certain kinds of stents.  They go in, and they can come out.  Nothing to see here.

We, however, are product liability litigators, so when we encounter an explanted medical device, odds are that it was removed because the patient experienced an alleged complication.  This is where we repeat the mantra of medical product liability law—all drugs and medical devices have both benefits and risks.  And, when a device comes out and the patient sues, what happens to the device?

That was the subject of a recent case called Dreger v. KLS Martin, L.P., No. 2:20-cv-3814, 2022 U.S. Dist. LEXIS 103088 (S.D. Ohio June 6, 2022), and the district court held that the defendant device seller could perform nondestructive testing on the explanted device at the location of its choosing.  In addition—and we think most importantly—unless and until the defendant disclosed the results of the testing as potential evidence, those results were protected attorney work product.

The plaintiff in Dreger alleged a defect in a titanium alloy rib plate that had to be removed, so the Defendant reasonably wanted to test the device.  To be clear, we are talking here about non-destructive testing.  Destructive testing is different because it can be done only once and cannot be repeated.  Because the device (or part of it) has been altered, if not completely destroyed, you have to do it under an agreed or court-ordered protocol so the party holding the device does not gain an unfair advantage.  It also goes without saying that altering or destroying potential evidence in litigation without an ironclad agreement is a really bad idea and prohibited.

But back to Dreger, the defendant wanted to inspect the explanted plate at the manufacturer’s world-class laboratory in Germany.  The plaintiff objected on the basis that the law did not require inspection in Germany and because the defendant might not give the device back.  Even to our jaded ears, these excuses are extremely thin.  Id. at *3-*4.  Perhaps the law does not require inspection in Germany, but the law surely permits it.  Here, the manufacturer’s lab had state-of-the-art equipment and the expert engineers necessary to conduct the proper non-invasive testing.  Moreover, the laboratory was subject to regulation by the FDA, and the facility was routinely inspected and approved by the FDA and other regulators.  Id. at *3.  Under these circumstances, when the plaintiff asked “why Germany,” the defendant and the district court appropriately replied “why not”?

The purported fear that the defendant would not return the device was even less credible.  The defendant stipulated that it would return the device, and “in almost 30 years of routine shipments between [the defendant] and [the manufacturer’s lab], no device has ever been lost. Plaintiff’s suggestion that she would be harmed if she did not have the Explanted Device for trial is purely speculative . . . .”  Id. at *6.

Finally, the district court rejected the plaintiff’s argument that her expert and/or counsel should be allowed to observe the testing.  The authorities that the plaintiff cited dealt with destructive testing, but that’s a different situation that calls for different rules (see above).  Moreover, unless and until the defendant elected to use the information from the inspection as evidence, the results of the inspection and testing were protected work product.  That includes “the work product generated by the inspection, along with the identities of, and facts known or opinions held by, [the defendant’s] consulting experts.  Id. *6-*7.

This last point is the most important.  Sure, the device manufacturer had the best lab and all, but ordering the defendant to find a proxy lab in the U.S. might not have been the end of the world.  On other hand, an order waiving the work product protection and allowing the plaintiff’s experts and lawyers to peer over the defendant’s shoulders could be downright disruptive.  It might even have persuaded the defendant to forego testing altogether.  Of course, these things go both ways, and the plaintiff’s expert will be allowed to conduct nondestructive testing without the defendant poking its nose in.  But all things considered, we’ll take it.

When we (belatedly) learned of the Supreme Court’s abolition of the so-called “presumption against preemption” in express preemption cases, that knowledge just about made our year.  Since then we’ve written several posts about that case, Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016), and its effect on preemption cases in our drug/device sandbox.  While such a presumption may have some merit when broad “field” preemption is considered, there’s simply no need for it when the subject is express preemption or preemption defined by conflict with federal law.

Here’s another presumption against preemption post – with a warning.

The case, Mata v. Allupick, Inc., 2022 U.S. Dist. Lexis 87656 (N.D. Ala. May 16, 2022), has nothing to do with prescription medical products.  Rather, it involves a truck accident.  One of the defendants, a freight broker, sought dismissal on preemption grounds – that a federal statute expressly preempted “any claim relating to how it performs its function of hiring motor carriers.”  Id. at *4.  We wouldn’t really care except, once Mata began discussing express preemption, it stated:

“[E]xpress preemption clauses must be construed narrowly” when “the subject matter, such as the provision of tort remedies to compensate for personal injuries, is one that has traditionally been regarded as properly within the scope of states’ rights.”

Id. at *5 (quoting Irving v. Mazda Motor Corp., 136 F.3d 764, 767 (11th Cir. 1998)).  While Mata nowhere mentions the former “presumption” that is now a post-P.R. v. Franklin no-no, that quote seemed highly suspicious.

So we took a look at Irving itself to see what, if any, relationship the quoted language might have to the now-defunct presumption against preemption.  Sure enough, in Irving that quote was inextricably intertwined with the erstwhile presumption against preemption:

[A] strong presumption exists against finding express preemption when the subject matter, such as the provision of tort remedies to compensate for personal injuries, is one that has traditionally been regarded as properly within the scope of the states’ rights.  Thus, express preemption clauses must be construed narrowly.

136 F.3d at 767 (citations, quotation marks, and footnote omitted) (emphasis added).  We’ve emphasized the language that Mata quoted.  Plainly, Mata simply deleted the “p word” and then applied the same substantive presumption-driven standard despite the Supreme Court’s express abolition of that presumption.

That’s dishonest – but unfortunately not uncommon.  What happened in Mata reminds us of:  (1) what happened after Fed. R. Civ. P. 26(b)(1) was amended to delete the much-abused “reasonably calculated” scope-of-discovery standard.  Courts sought to evade the new, tighter standard by citing Oppenheimer Fund, Inc. v. Sanders, 437 U.S. 340, 351 (1978), which applied the old standard, without mentioning that the Rule had been changed.

Mata also reminds us of:  (2) the numerous courts that ignored the 2010 amendment to Fed. R. Evid. 702 and cited to superseded precedent.  These decisions did that in order to keep holding issues, such as the sufficiency of the factual basis for expert testimony, to be jury questions when the new Rule 702 expressly consigned them to the court’s gatekeeping function.  We discussed that phenomenon in our “Don’t Say Daubert” post, here.  As we also discussed, that continuing sabotage of the 2010 amendment recently prompted yet another amendment to Rule 702, which was recently approved by the Advisory Committee on Evidence Rules.

Mata leads us to warn our readers to be on the lookout for similarly retrograde arguments and opinions concerning express preemption.  We need to call out Plaintiffs who argue for the same old presumption against preemption-influenced standards, only without using the dreaded p-word.  Equally, decisions like Mata that do the same deserve criticism for their attempts to evade controlling Supreme Court precedent.

An amendment to the FDCA, called the “Verifying Accurate Leading-edge IVCT Development Act” – or VALID Act (cute) for short – has been wending its way through Congress.  It appears intended to codify FDA regulatory authority over in vitro chemical tests, and is not the kind of thing we would ordinarily concern ourselves with on this Blog.  It’s not like such tests have been a product liability hotbed.  In fact, when searched for that term, we received zero results.

Section 587U of the proposed Act concerned preemption and, until recently, read:

“(a) In General.—No State, Tribal, or local government (or political subdivision thereof) may establish or continue in effect any requirement related to the development, manufacture, labeling, distribution, sale, or use of an in vitro clinical test that is different from, or in addition to, the requirements of this subchapter.

“(b) Exceptions.—Subsection (a) shall not be construed to affect the authority of a State, Tribal, or local government—

“(1) to license laboratory personnel, health care practitioners, or health care facilities or to regulate any aspect of a health care practitioner-patient relationship; or

“(2) to enforce laws of general applicability, such as zoning laws, environmental laws, labor laws, and general business laws.

“(c) Clarification.—This section shall not be construed to shift liability to health care practitioners or other users.

That’s pretty standard preemption language for an FDCA amendment.   Indeed, the operative language – “different from, or in addition to” – is the same as the 1976 Medical Device Amendments, and thus has a well-defined scope.

Now, however, the proposed draft of the VALID Act has been amended in an ominous way effectively to nullify the FDA new powers by making them meaningless in civil litigation.  

Here’s the proposed as-amended language as we understand it:

“(a) In General.— Except as provided in subsection (b), no No State, Tribal, or local government (or political subdivision thereof) may establish or continue in effect any requirement related to the development, manufacture, labeling, distribution, sale, or use of an in vitro clinical test that —

(1) is different from, or in addition to, the requirements of any requirement applicable to an this subchapter of in vitro clinical test under this Act; or

(2) any requirement applicable to an respect to the analytical validity, clinical validity, or safety for individuals who come into contact with such an in vitro clinical test under this subchapter Act.

(b) Exceptions.—Subsection (a) shall not be construed to affect the authority of a State, Tribal, or local government—

(1) to license laboratory personnel, health care practitioners, or health care facilities or to regulate any aspect of a health care practitioner-patient relationship; or

“(2) to enforce laws of general applicability, such as zoning laws, environmental laws, labor laws, and general business laws;

(3) to authorize laboratories to develop and perform an in vitro clinical test, pursuant to a law enacted by a State prior to January 1, 2022, as long as such law does not impose requirements that are different from any requirement applicable to an in vitro clinical test under this Act.

(c) Clarification.—This Nothing in this section shall not be construed to—

(1) modify any action for damages or the liability of any person under the law of any State; or

(2) shift liability to health care practitioners or other users.

Additions in italics; deletions in strike through.

As the draft VALID Act now reads, the to-be FDA-regulated manufacturers of in vitro chemical tests would be stripped by the revised “clarification” of any litigation benefit from the Act’s imposition of potentially onerous FDA oversight.   By this we mean, they are not only does the amendment eliminate outright preemption, such as exists under the Medical Device Amendments, but regulated test manufacturers would also be deprived of lesser “modifications,” such as whatever evidentiary effect state law would afford a manufacturer’s compliance with the FDA regulatory scheme.

This surprise act of legislative vandalism is indeed unfortunate.   There are undoubtedly good reasons for extending the FDA’s writ to these tests, but now congressional litigation allenablers have made this bill unnecessarily controversial by making the persons the VALID Act would regulate sitting ducks for litigation.