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For any of our loyal readers looking to start the New Year with a healthy helping of CLE credit, a friendly reminder that four of your bloggers – Bexis, Steven Boranian, Stephen McConnell, and Lisa Baird – will be presenting a free 90-minute CLE webinar on “The good, the bad and the ugly: The best and worst drug/medical device decisions of 2023” on Thursday, January 25th at 12 p.m. EST. The webinar will  provide further insight and analysis on the cases featured in our posts on the worst decisions and best decisions of the past year.

This program is presumptively approved for 1.5 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance. Additionally, please note that CLE credit for on-demand viewing is only available in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia. Credit availability also expires two years from the date of the live program.

The program is free and open to anyone interested in tuning in, but you have to sign up in advance here.

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On February 6, Dechert is proud to host the 2024 Life Sciences Day, an interdisciplinary program designed for in-house counsel, chief officers, and strategic investors. This dynamic half-day event will feature expert panels discussing key issues in the life sciences sector and include speakers from leading pharmaceutical and biotech companies.  

Our panelists will guide you through the life sciences landscape, from product development to post-launch litigation. You’ll have the opportunity to hear from industry insiders on emerging legal, regulatory, and business challenges, as well as effective risk mitigation strategies. Click here to register.

The topics we’ll cover include:

·        Cybersecurity and privacy risks to life sciences companies, including the impact of AI on the threat landscape

·        Recent developments in complex and securities litigation against U.S. life sciences companies

·        Key considerations for an effective M&A strategy

·        How scientific evidence can win a product liability case

·        Strategies for managing multiple litigation fronts once you go to market

In addition, we’re excited to host a fireside chat with Sir Gregory Paul Winter, a Nobel-Prize winning molecular biologist. Sir Winter’s groundbreaking work has revolutionized the field of medicine paving the way for the development of numerous transformative, life-saving therapies, and has been cited by many courts in complex life sciences cases, including the U.S. Supreme Court in a 2023 seminal patent case.

Event Details:

Location: CYTO | PHL, Cira Centre, 2929 Arch Street, Philadelphia, PA 19104

Date: Tuesday, February 6, 2024

11:45 a.m. – Registration

12:15 p.m. – Program

5:00 p.m. – Networking reception

Join us for an enlightening day of discussion and networking. We look forward to seeing you there!

CLE Information:

Applications for accreditation of this program for Continuing Legal Education in Massachusetts, New Jersey, New York, and Pennsylvania are currently pending.

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We’ve been posting about decisions from In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, MDL 2775, since 2018.  Its preemption ruling on defendant’s motion to dismiss made the list of ten worst decisions from 2018, and a subsequent preemption decision reflected more MDL madness.   Things improved when the court began addressing causation at summary judgment, and pretty soon cases were falling like dominoes.  Today’s decision from the MDL, Williams v. Smith & Nephew, Inc., 2024 WL 99542 (D. Md. Jan. 8, 2024), continues that positive trend.

Continue Reading Another Dismissal in the Birmingham Hip MDL
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Back in 2020, we noted the possible broad implications of a Buckman preemption decision in a somewhat unusual economic loss case that turned on whether a compounded pharmaceutical needed FDA approval through an NDA.  When that case, Nexus Pharms., Inc. v. Cent. Admixture Pharm. Servs., Inc., 48 F.4th 1040 (9th Cir. 2022), was affirmed in the Ninth Circuit, we bestowed on the decision to distinct honor of being our third best decision of 2022.  Part of our thinking was that California had a number of statutes that facilitated economic loss lawsuits over food labeling and, thus, had a bunch of such cases in its state and federal courts.  We have posted on a number of these cases over the years and, if we can summarize them, they are often over pretty piddly issues and have inconsistent results when it comes to what claims are preempted.  The reliance in Nexus on the provision in 21 U.S.C. § 337(a) that essentially bars private enforcement of purported violations of the FDCA promised to impliedly preempt a number of claims under California law that turn on FDA regulatory status.  

It has.  Not long ago, we posted on a California federal court decision relying on Nexus to preempt all claims in a case about additives in a cosmetic product, even where the complaint had been amended to pretend the FDCA did not exist.  The decision in Bubak v. GOLO, LLC, No. 1:21-cv-00492-DAD-AC, 2024 WL 86315 (E.D. Cal. Jan. 8, 2024), relates to another second chance.  The decision on defendant’s original motion to dismiss based on Buckman left some purportedly parallel claims standing.  Then Nexus came out and the defendant moved to reconsider.  The motion to reconsider was pending for more than a year, but that delay allowed the Bubak court to survey the federal court decisions following Nexus.  Although only three are cited by name—including the cosmetic case mentioned above—there were apparently five, one of which was from the Ninth Circuit itself.  None of the three cited decisions looks like it came from a food labeling case.  That is enough to show us that Nexus is having some ripples on California state law claims that used to escape the reach of preemption.

The facts of Bubak included in the decision are sparse, so we used the magic of the internet to find out a little more.  The plaintiff claimed that defendant’s supplement was really a drug that needed an NDA approval before it could be marketed and then would have to be labeled like a drug.  The supplement at issue, with the somewhat oblique name Release Supplement, has as its “active” ingredients zinc, magnesium, chromium, a sugar alcohol, and extracts from six plants (e.g., apples).  Elements, simple naturally occurring compounds, and plant extracts tend not to be treated as drugs.  The combination of them in this supplement was marketed as helping with a range of things like losing weight, improving energy, and reducing stress.  Those sound more like supplement claims than drug claims about specific disease states.  It is also pretty fundamental that whether a substance does or does not require an NDA is a matter for FDA to decide.

As in Nexus, the California state laws under which the Bubak plaintiff sought to proceed were laws that said “in substance ‘comply with the FDCA.’”  That meant that the plaintiff was trying to enforce the FDCA, which ran afoul of § 337(a) and impliedly preempted the claims.  The court characterized its reversal of the prior decision because of an intervening change in the law as a “reluctant[]” one.  This stemmed from the fact that Nexus did not address California’s Sherman Law and pre-Nexus cases had often held claims under that law not to be preempted.  Given our known views on the over-use of the appellation “parallel claim” as a way to get around obvious and appropriate preemption, we do not share the court’s reluctance.  However, given how many cases there are based on this and similar California laws that piggyback on the FDCA, we do expect there will be another decision from the Ninth Circuit in the not-too-distant future address the issues the Bubak court wanted, maybe even in an appeal of Bubak itself.

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Two years ago we posted on whether courts could exclude prospective jurors for cause because they weren’t vaccinated.  Not much precedent was then available. 

Now, with United States v. O’Lear, 2024 WL 79971 (6th Cir. Jan. 8, 2024), we get the first published appellate decision on the topic, affirming the exclusion.  (The Ninth Circuit okayed such exclusions in a couple of unpublished memoranda dispositions.)

O’Lear is a criminal case, in which the defendant was convicted by a jury of healthcare fraud (billing Medicare and Medicaid for fictitious mobile X-rays at nursing homes) and aggravated identity theft.  The defendant on appeal raised several issues, including substantive criminal law points, vindictive prosecution, and whether the “vulnerable victim” sentence increase was correctly applied.  But for our purposes here on the DDL blog, the pertinent issue is whether the trial court erred by excluding unvaccinated people from the jury pool.  

Unlike in our prior post on exclusion of the unvaccinated, in O’Lear it was the defendant, not the prosecution, who objected.  In fact, that is the posture of most cases where the composition of the jury pool is challenged.  Note that the legal issue is about whether the jury pool, not the final empaneled jury, is a cross section of the community. When a defendant argues that the jury pool is not a cross section of the community, that defendant must identify a “distinctive” group that was excluded.  As the O’Lear court explains, the word “distinctive” is, by itself “amorphous” and unhelpful. After all, felons could be considered a distinctive group, but their exclusion is (at least for now) not viewed as problematic.  

To determine whether a “distinctive” group was excluded in such a way as to make a jury pool unrepresentative, a court must inquire whether the exclusions of potential jurors were “arbitrary” and whether the exclusions posed a real risk of unfairness to the defendant. Also at issue is whether the members of the excluded group had been unfairly deprived of “their basic right of citizenship.” The defendant in O’Lear lost because, “[u]n like members of a particular race or sect, the unvaccinated do not qualify as the type of ‘distinctive group’ that can trigger Sixth Amendment concerns with excluding a ‘fair cross section of the community’ from the jury pool.” First, the exclusion was based on legitimate health and administrative concerns. The unvaccinated could disrupt the potentially lengthy trial if they became ill and exposed others to the virus. Second, the defendant did not show that the unvaccinated harbor such uniform and unique attitudes that their exclusion would dilute the representativeness of the jury. The defendant offered mere speculation about whether the unvaccinated tend to be more “antigovernment” and, therefore, more favorably disposed toward criminal defendants. Third, not one of the groups allegedly disadvantaged by barring unvaccinated jurors – those living in rural counties, young adults, and those skeptical of the government − was “historically disadvantaged” or possessed “immutable” traits.  

The alleged disparate impact on minorities (which, frankly, to us seemed to be iffy or even flat out wrong) did not rise to a constitutional violation.  To hold otherwise would implicate the widespread practice of drawing juries from lists of registered voters, as well as age limitations on jury service. 

Nor was exclusion of the unvaccinated a permanent deprivation of a citizen’s ability to serve on the jury. Citizens can freely get vaccinated whenever they choose. The prohibition imposed no absolute bar.  The exclusion was also temporary.  Clearly, Covid-19 will go away some day. Right?

Since O’Lear was a criminal case, the argument was about Sixth Amendment constitutionality. While the composition of civil trials is also subject to constitutional protections (think of Batson and peremptory challenges), courts are especially protective of criminal defendants’ Sixth Amendment rights.  Liberty is at stake in criminal cases.  The absence of that concern in civil cases makes us think that the Sixth Circuit’s ruling blessing exclusion of unvaccinated jurors probably applies a fortiori to civil cases. In other words, a civil litigant who objected to exclusion of the unvaccinated and later lost the case will likely have a tough time on appeal arguing for reversal based on the exclusion. 

While the Covid-19 urgency has possibly (?) subsided, and many courts are now less attentive to the vaccination issue, there are still courts that will exclude the unvaccinated.  Consequently, it is still a live question whether FDA-regulated defendants in product liability cases would prefer to have antivaxxers excluded from jury service. We leave that question to you and your jury consultants. 

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Not long ago we posted about how a turncoat expert witness who switched to the dark side had been precluded from testifying in several cases.  We have another case to add to the list – King v. Depuy Orthopaedics Inc., 2023 U.S. Dist. LEXIS 223451 (D. Ariz. Dec. 15, 2013).  Only this time, Plaintiff argued the turncoat expert should be permitted to testify as a fact witness.  But the court saw that has a distinction without a difference. 

Specifically, plaintiff claimed to want the expert to testify regarding comments he made to an FDA advisory panel in 2001, his discussions with other panel members, and the panel’s decisions.  Id. at *5.  But that “purely fact testimony” was inadmissible for several reasons.  First, his discussions with FDA panelists are hearsay. And even if plaintiff claimed to offer them not as evidence of a defect but just as notice, the court did not see the difference and didn’t think a jury would either.  As far as evidence of notice of defect goes, it is the same as evidence attempting to prove the defect and therefore is inadmissible hearsay.  Id. at *6. 

Second, the testimony plaintiff wants to offer is still expert testimony—it involves the witness’ “specialized knowledge” beyond what a lay person would know.  Lay opinion testimony should not concern “specialized explanations or interpretations that an untrained layman could not make if perceiving the same acts of events.”  Id. at *7.  It can hardly be disputed that a non-medical professional would perceive or understand the FDA panel discussions the same way an expert would.  So, the turncoat expert’s testimony as a “fact” witness would largely overlap with what he would have testified about as an expert, making it inadmissible. 

Finally, the court concluded that allowing the turncoat to testify as a lay witness would lead to jury confusion.  Id. at *8.  The court could not discount that jurors would afford greater credibility to the turncoat’s testimony based solely on who he is, an expert in the field. 

Bottom line, if he walks, talks, and looks like an expert—he’s an expert.  And if he’s a turncoat expert, his testimony is inadmissible.    

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As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability.  That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.  There was considerable speculation that the seminal case, Lewis v. Coffing Hoist Division, 528 A.2d 590 (Pa. 1987), may no longer control because it was based on a peculiarly strict approach to strict liability – what we call a negligence/strict liability dichotomy − that the Pennsylvania Supreme Court appeared to have overruled and rejected in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014).  Neither Lewis nor Tincher involved prescription medical products, but rather what we describe as “things that go clank.”

However, Pennsylvania’s intermediate appellate court decided otherwise in Sullivan v. Werner Co., 253 A.3d 730 (Pa. Super. 2021), aff’d by an equally divided court, 2023 WL 8859656 (Pa. Dec. 22, 2023) (“Sullivan I”), another decision not involving prescription medical products.  Sullivan I held that, under Pennsylvania’s interpretation of Restatement (Second) of Torts §402A (1965):

[I]t is irrelevant if a product is designed with all possible care, including whether it has complied with all industry and governmental standards, because the manufacturer is still liable if the product is unsafe. . . .  Under such reasoning, evidence of industry standards may be excluded because those standards do not go to the safety of the product itself but to the manufacturers’ “possible care in preparation of product,” which is irrelevant to whether a product is unsafe or strict liability is established.

Id. at 747 (citation omitted).  The Superior Court panel thus found no abuse of discretion in the exclusion of standards compliance evidence in a strict liability design defect case.

Sullivan I was appealed to the Pennsylvania Supreme Court.  A couple of months after Sullivan I, the Third Circuit certified a different-but-related question to the Pennsylvania Supreme Court:

Under Pennsylvania law, are prescription implantable medical devices categorically subject to strict liability, categorically immune from strict liability, or immune from strict liability on a case-by-case basis?

Ebert v. C.R. Bard, Inc., 2021 WL 2656690, at *6 (3d Cir. June 24, 2021).  The Pennsylvania court accepted the certified question.  Ebert v. C.R. Bard, Inc., 260 A.3d 81 (Pa. 2021).  However, Ebert settled without a decision.  See Ebert v. C.R. Bard, Inc., 2021 WL 9950511 (3d Cir. Nov. 10, 2021) (granting unopposed motion to dismiss pursuant to settlement).

We discussed the Ebert appeal here because plaintiff-side amici in Ebert had repeatedly misrepresented to both the Third Circuit, and then to the Pennsylvania Supreme Court, that Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006) – a precedential holding that the same Pennsylvania rule barring strict liability claims against prescription drugs also applied to prescription medical devices − should not be followed because the plaintiffs in Creazzo were supposedly “pro se.”  That was false, based on a printer’s error, and that error has now been corrected.  But in the interim, plaintiffs did manage to peddle that falsehood successfully to four federal district judges, as our post detailed.

Well, Sullivan I has now been affirmed, sort of.  First, full disclosure, Bexis handled the defense side of the Pennsylvania Supreme Court appeal in Sullivan.  The reason we say “sort of” is that the Pennsylvania high court did not affirm with any precedential order or opinion.  Three of the six sitting justices – not a majority − held that, notwithstanding Tincher, the prior bar to admissibility of standards compliance evidence should remain.  “We conclude that evidence of compliance with industry standards is inadmissible under the risk-utility test in strict products liability cases. In this regard, we reaffirm the post-Tincher validity of the rule announced in Lewis.”  Sullivan v. Werner Co., 2023 WL 8859656, at *9 (Pa. Dec. 22, 2023) (Opinion Announcing the Judgment of the Court (“OAJC”)).  The OAJC did not consider decisions of governmental or standards-setting organizations to be relevant to strict liability:

[C]ompliance evidence is simply evidence of the ultimate conclusion that a product complies with government regulations or industry standards, i.e., that a government agency or industry organization would deem the product not defective.  It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence.  We agree with the Lewis Court’s assessment that the focus of a design defect case must be limited to the characteristics of the product, and not the conduct of the manufacturer or seller.

Id., OAJC, 2023 WL 8859656, at *11.  “That OSHA or ANSI would deem a defendant’s conduct compliant with its standards is not relevant to the risk-utility test and diverts the jury’s attention from the relevant inquiry.”  Id.  Finally, the OAJC was not concerned with Pennsylvania being a “minority” of one (Montana, the only other holdout, having flipped while Sullivan was pending) in excluding standards compliance evidence in strict liability cases.

Appellants’ argument that our decision places Pennsylvania in a minority position regarding the inadmissibility of compliance evidence is unavailing.  Our decision is based on our analysis and application of Pennsylvania precedent regarding the development of strict product liability.  We adhere to Section 402A’s principle that strict liability may be imposed even if a defendant exercised “all possible care”. . . .  It reflects the “social and economic policy of this Commonwealth.”

Id. at *12 (quoting Tincher, 104 A.3d at 381).

A fourth Justice concurred in the result, treating the issue of standards compliance in Sullivan as a matter of evidence, and holding that the lack of a sufficient trial record supporting the relevance of the specific standards at issue in Sullivan meant that the trial judge’s exclusion was not an abuse of discretion.

Based on the record in this case developed on [plaintiffs’] Motion in Limine . . . and [defendants’] response thereto, the trial court did not abuse its discretion by disallowing the evidence.  In my view, the complicated legal issue presented in this appeal is unfortunately not resolvable because of the undeveloped evidentiary record and undirected advocacy in the trial court.

Sullivan, Donohue Concurrence in the result, 2023 WL 8859656, at *13.  This opinion was took a “more nuanced” view of the admissibility of standards compliance evidence in strict liability, id., and accepted the defendants’ “workable” argument that “producing a product that is designed pursuant to the industry or government standard makes evidence of the standard relevant to the question of whether the product is defective.”  Id.  But in the view of this Justice, the trial record lacked sufficient evidence to overturn the trial judge’s exclusion.  “[T]he jury was instructed to consider a variety of factors in determining whether the product at issue was unreasonably dangerous” but defendants “did not attempt to establish the relevance of the applicable industry standards to any of [those] factors.”  Id.

Nor were the actual standards at issue in the record (since they had been excluded in limine).  “From the outset, I was struck by the omission from the record of the actual ANSI or OSHA standard sought to be admitted.”  Sullivan, Donohue Concurrence, 2023 WL 8859656, at *14.  “[B]aldly stating that a product complied with [relevant] standards is meaningless to a court tasked with determining the relevancy of the evidence,” so exclusion in Sullian was not an abuse of discretion.  Id. at *15.  “A trial court would be within its exercise of discretion to exclude the evidence if it concluded that a sub-trial on the weight to be given to [the] standards would confuse the jury and distort the focus from the product at issue.”  Id. at *16.

Finally, two Justices dissented, taking the view that standards compliance evidence should generally be admissible in strict liability, as it is in every other state in the country.

[U]nder Pennsylvania’s broad relevancy rules, governmental and industry standards should be admissible in products liability design defect matters.  Additionally, the overwhelming majority of our sister states find governmental and industry standards evidence to be admissible. . . .  [T]he OAJC’s exclusion of governmental and industrial standards to defend against a defective product claim, at its core, reflects a mistrust of our jury system and suggests juries cannot understand these complex matters. . . .  Our entire jury system relies upon the adversarial presentation of evidence and argumentation. It should be no different in the area of products liability.

Sullivan, Dissent, 2023 WL 8859656, at *18-19 (citation omitted).

Thus, in a Pennsylvania strict liability action, a paid plaintiff’s expert may offer a design defect opinion based on untested and untried “alternatives,” while the considered judgment of governmental and professional standards setting organizations is not even admissible.  So what now, and in particular how does Sullivan impact prescription medical product liability litigation? 

First, the none of what you just read about the Supreme Court decision in Sullivan is precedential in Pennsylvania.  The Pennsylvania Supreme Court split 3-3 on the core question of whether standards compliance evidence is categorically inadmissible in strict liability cases.  The only binding precedent in Sullivan is the Superior Court’s decision, which followed the per se exclusionary rule because compliance evidence is “irrelevant to whether a product is unsafe or strict liability is established,” Sullivan I, 253 A.3d at 747, and it was up to the high court to change the rule it created.  Id. (while “our Supreme Court may allow industry and governmental standards . . ., until it does, Tincher neither explicitly nor implicitly overrules the exclusion”).

This outcome in Sullivan greatly increases the importance of Pennsylvania’s aforementioned rule generally applying Restatement (Second) of Torts §402A, comment k (1965), to preclude strict liability (except conceivably for manufacturing defects) against manufacturers of prescription medical products.  Tincher itself recognized this exception to strict liability.

No product is expressly exempt [from strict liability] and, as a result, the presumption is that strict liability may be available with respect to any product, provided that the evidence is sufficient to prove a defect . . .; but see Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (1996) (manufacturer immune from strict liability defective design claim premised upon sale of prescription drugs without adequate warning).

Tincher, 104 A.3d at 382 (other citations omitted).  As discussed above, this rule has been under attack in medical device cases, mostly in federal courts (who have no business, under Erie, expanding liability under Pennsylvania law), and in at least in four cases due to p-side misrepresentations concerning the Creazzo precedent.

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation.  You can bet your bottom dollar that, should prescription medical products (or any category of them) be subjected to “strict liability” in Pennsylvania, plaintiffs will seek to exclude FDA compliance evidence in all cases involving such products.  In state court, Creazzo remains binding precedent.  In federal court Creazzo isn’t technically binding, but precedential intermediate appellate decisions are by far the most persuasive evidence basis for an Erie prediction – precisely why plaintiffs consistently misrepresented Creazzo as a “pro se” case in federal court.

Thus, it is critical post-Sullivan to maintain Pennsylvania’s well-recognized and long-standing prescription medical product exception to strict liability.  We offer our prior comprehensive post on this subject.  In particular, defendants in medical device cases should rely on the overlooked decision in Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521 (Pa. 1995), which precluded strict liability allegations in a prescription medical device case:

In Cafazzo, the plaintiff unsuccessfully sought to hold a hospital strictly liable as an intermediate seller of an allegedly defective a jaw implant.  The court refused to apply strict liability, holding “that even if [defendants] could be shown to have ‘marketed’ the prosthesis, strict liability does not apply.”  Id. at 523.  The no-fault, cost-shifting “policy” of strict liability did not justify converting claims otherwise sounding in negligence to strict liability.  “To assign liability for no reason other than the ability to pay damages is inconsistent with our jurisprudence.”  Id. at 526 (citation omitted).  “[R]esearch and innovation in medical equipment and treatment would be inhibited.”  Id. at 527.  Cafazzo therefore refused to expand strict liability.

[B]efore a change in the law is made, a court, if it is to act responsibly must be able to see with reasonable clarity the results of its decision and to say with reasonable certainty that the change will serve the best interests of society. . . .  It is . . . not clear enough that strict liability has afforded the hoped for panacea in the conventional products area that it should be extended so cavalierly in cases such as the present one.

Id. at 527 (citation and quotation marks omitted).  Thus, Creazzo is not the only Pennsylvania appellate decision rejecting strict liability against medical devices – the Pennsylvania Supreme Court has also rejected strict liability in such cases (albeit against a hospital defendant), and we should say so.

Second, defendants should not let plaintiffs sneak their own negligence-based arguments into strict liability cases.  Plaintiffs like to insert what the Sullivan OAJC would consider “conduct” based evidence and argument into what they nonetheless call “strict liability.”  Common allegations of this sort are “failure to test,” “failure to recall,” “failure to report” adverse events to the FDA, and “per se” liability for purported FDCA violations.  Pennsylvania, however, recognizes only “three different types of defective conditions that can give rise to a strict liability claim: design defect, manufacturing defect, and failure-to-warn defect.”  E.g., Sullivan, OAJC, 2023 WL 8859656, at *2 n.1 (quoting Phillips v. A-Best Products Co., 665 A.2d 1167, 1170 (Pa. 1995).  Additional theories, asserting liability grounded in alleged deficiencies in testing, recall, or reporting procedures, or because a defendant purportedly broke some law, are based on that manufacturer’s claimed conduct, and therefore sound in negligence – to the extent that Pennsylvania law would recognize them at all (which the above links demonstrate is generally not the case).  A plaintiff’s pursuit of such theories thus should allow admission of standards compliance evidence.

An illustrative example is Hrymoc v. Ethicon, Inc., 297 A.3d 1245 (N.J. 2023), a pelvic mesh case where exclusion of FDA compliance evidence was held error, even under an abuse of discretion standard, because the plaintiff harped on an alleged failure to test after winning exclusion, and thus prevented the defendant from countering that the selfsame product tests plaintiffs were demanding were not required by the FDA:

[I]t was unfair for the trial court not to allow [defendant] to explain in response that it received 510(k) clearance to market the devices without clinical studies or trials.  Indeed, in making [defendant’s] failure to conduct clinical trials or studies of the [product] a central theme of their case, plaintiffs “opened the door” to the admission of 510(k) evidence, notwithstanding the trial court’s exclusion.

Id. at 1261 (citation omitted).

What’s sauce for the goose should be sauce for the gander.  If compliance evidence is excluded in Pennsylvania as “negligence” or “conduct” evidence, then plaintiffs should likewise be precluded in strict liability cases from making claims based on a defendant’s conduct, rather than the actual condition of the product. Just like we did before Tincher, we need to be objecting early and often to plaintiffs’ attempts to disguise negligence claims and conduct evidence as “strict liability,” including the filing of appropriate motions in limine focused on plaintiffs thereby opening the door to our use of standards compliance evidence.

Third, and somewhat related to the second point, as the dissent in Sullivan pointed out, pre-Tincher Pennsylvania law applied the bar to standards compliance evidence unevenly, essentially giving plaintiffs free reign to “open the door” to such evidence whenever they find it helpful to their case:

[G]overnmental and industry standards are admissible in a plaintiff’s case.  Gaudio v. Ford Motor Co., 976 A.2d 524, 544 (Pa. Super. 2009).  In my view, it is patently unfair to allow such standards into evidence in a plaintiff’s case, but not in the defense’s case.  If evidence of governmental and industry compliance was irrelevant to strict liability, then such evidence should be inadmissible for both plaintiff and defendant alike.

Sullivan, Dissent, 2023 WL 8859656, at *19.

True, Gaudio does so hold.  But whether that one-way door remains good law is unclear after Sullivan.  The precedential Superior Court decision did not address that aspect of Gaudio, focusing only on Gaudio’s expansion of Lewis to encompass government, as well as industry, standards.  Sullivan I, 253 A.3d at 741, see id. at 748 n.10 (expressly “not address[ing]” any door opening issue).  In response to the Sullivan dissent’s harsh criticism of plaintiffs, but not defendants, being able to admit standards-related evidence, neither the OAJC nor the Donohue Concurrence defended the Superior Court’s pre-Tincher door-opening precedent.

The OAJC’s view of standards compliance evidence, moreover, suggests  that “door opening” may no longer be appropriate.  Compliance was merely “the ultimate conclusion that a product complies with government regulations or industry standards,” and “not evidence of the underlying attributes of the product.”  Sullivan, OAJC, 2023 WL 8859656, at *11.  If, as the OAJC posits, “[c]ompliance evidence does not prove any characteristic of the product,” but instead “diverts [the jury’s] attention” to matters not “pertinent to” a design defect claim,” id., then the same evidence should not be relevant to a plaintiff’s case either.  The OAJC references not only “the manufacturer’s conduct,” but also “whether a standards-issuing organization would consider the product to be free of defects.”  Id.  Consequently, whether a product did not comply with the same standard would similarly “divert” the inquiry, and “whether a standards-issuing organization would consider the product to be free of defects” would logically be equally relevant, or not, whether the answer to that question is “yes” or “no.”

Thus, while Gaudio remains binding precedent, the logical and legal basis for allowing a plaintiff to admit non-compliance evidence essentially at will is questionable post-Sullivan, and not a single member of the Pennsylvania Supreme Court seemed willing to defend the practice.  Going forward, this is an issue that defendants should strongly consider preserving.

Fourth, how will conflict of law principles affect application of the Pennsylvania exclusionary rule?  There are two aspects to this question, and they potentially cut in different directions.  As essentially everyone now knows, Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023), upheld against a Due Process challenge a unique Pennsylvania statute that imposes general personal jurisdiction on any Pennsylvania-registered foreign corporation.  Pennsylvania is a relatively large state, so most (if not all) major product manufacturers are so registered.  Thus (unless and until the Dormant Commerce Clause puts a stop to it) any plaintiff anywhere in the country can sue Pennsylvania-registered drug or device manufacturers in Pennsylvania courts.

One question is thus whether Pennsylvania’s per se ban on standards compliance evidence is “substantive” or “procedural” (that shorthand is actually a minefield) for choice of law purposes with respect to Mallory progeny cases that otherwise must apply other states’ “substantive” law.  The second question involves another version of the “substantive”/“procedural” divide, this time between state and federal courts, both applying Pennsylvania law.  This question is an application of Hanna v. Plumer, 380 U.S. 460 (1965), since in federal court the admissibility of evidence is governed by the Federal Rules of Evidence.  E.g., Rolick v. Collins Pine Co., 975 F.2d 1009, 1013 (3d Cir. 1992).

These two questions can lead to different results.  Taking the second one first, in Rolick, the Third Circuit held that the admissibility of standards compliance generally (not in a strict liability case) is governed by the relevance standards of the Federal Rules of Evidence, not by Pennsylvania law.  The Third Circuit has already held that admissibility of standards compliance evidence in Pennsylvania-law diversity cases is governed by the relevance standards of the Federal Rules of Evidence.  See Covell v. Bell Sports, Inc., 651 F.3d 357, 366 (3d Cir. 2011) (federal rules “control in this case because they are ‘arguably procedural’”)

The issue to be decided here is whether the OSHA regulation is admissible in a diversity action as evidence of the standard of care owed by the defendants to the plaintiff. . . .  Since the question involves the admission of evidence in a federal court, the Federal Rules of Evidence control. . . .  We can think of no reason under the Federal Rules of Evidence why the OSHA regulation is not relevant evidence of the standard of care once it is determined, as we have done, that under Pennsylvania law the defendants could owe plaintiff a duty of care. . . .  [We] “borrow” the OSHA regulation for use as evidence of the standard of care owed to plaintiff.

Rolick, 975 F.2d at 1013-14.  Similarly, in Forrest v. Beloit Corp., 424 F.3d 344, 354 (3d Cir. 2005), the court (pre-Tincher) held that admissibility of evidence of lack of similar occurrences was a procedural question governed by the federal rules in diversity cases, not by an on-point Pennsylvania Supreme Court decision:

While the well-reasoned decision [of the Pennsylvania Supreme Court] provides useful guidance, the question presented is governed by federal rather than state law.  The admissibility of the evidence ultimately turns on a balancing of its probative value versus its prejudicial effect, and we have held that in a federal court the Federal Rules of Evidence govern procedural issues of this nature.

Id. at 354 (citations omitted).  Cf. Diehl v. Blaw-Knox, 360 F.3d 426, 431 n.3 (3d Cir. 2004) (pre-Tincher product liability case; “assessment of the dangers of unfair prejudice and confusion of the issues are procedural matters that govern in a federal court notwithstanding a state policy to the contrary”); Kelly v. Crown Equipment Co., 970 F.2d 1273, 1278 (3d Cir. 1992) (federal rule admitting subsequent remedial measures “is ‘arguably procedural,’ and therefore governs in this diversity action notwithstanding Pennsylvania law to the contrary”).  Thus, controlling Third Circuit precedent would require, post-Sullivan, that Pennsylvania’s per se exclusion of standards compliance evidence not apply in federal court, given the liberal relevance standards of Fed. R. Civ. P. 401 and 402.

However, there is language in the Sullivan OAJC that plaintiffs could use to assert that the exclusionary rule is a matter of substantive Pennsylvania law.  As we’ve already discussed, the OAJC stated that standards compliance “is not evidence of the underlying attributes of the product . . ., which is presumably admissible subject to the ordinary Rules of Evidence.”  2023 WL 8859656, at *11.  That suggests that Pennsylvania substantive law places limits on compliance evidence beyond the scope of, at least, Pennsylvania’s evidentiary rules.  Similarly, the closing paragraph embracing the “minority position” invokes “the social and economic policy of this Commonwealth” as grounds to keep standards compliance evidence away from Pennsylvania jurors.  Id. at *12.  We also note that Lewis itself predates the adoption of the Pennsylvania Rules of Evidence.

We present both sides of this issue because the other choice of law question:  what law applies to Mallory progeny cases where other states’ laws would otherwise govern, raises contrary considerations.  Pennsylvania procedural rules – but not Pennsylvania substantive law – apply in Pennsylvania courts.  E.g., Commonwealth v. Sanchez, 716 A.2d 1221, 1223 (Pa. Super. 1998).  We haven’t seen standards compliance litigated, but T.M. v. Janssen Pharmaceuticals, Inc., 214 A.3d 709 (Pa. Super. 2019), analogously held that the standard for admission of expert testimony was “procedural” and therefore Pennsylvania’s Frye rule applied, not Texas’ stricter expert admissibility standard.  Id. at 721-22.  It also appears that, unlike the OAJC, the Donovan Concurrence treats the issue as procedural, since it employed the abuse of discretion standard applicable to evidentiary rulings, rather than the de novo standard governing legal questions that the OAJC used.

Thus, in articulating their positions following Sullivan, defense counsel need to consider carefully the differences and similarities between these two “substance”/”procedure” tests – recognizing that what is considered “substantive” and what is “procedural” has the potential to affect the application of Sullivan I’s post-Tincher exclusionary rule differently.  To the extent that courts deem the two applications of “substance” versus “procedure” analogously, what restricts the exclusionary rule in one situation, may well expand it in the other.

Fifth, if a plaintiff is seeking punitive damages, standards compliance evidence is admissible notwithstanding “strict liability” being the underlying cause of action.  The Pennsylvania Supreme Court so held in Phillips v. Cricket Lighters, 883 A.2d 439 (2005):

[A]t the time this [product] was sold, it complied with all safety standards.  Of course, compliance with safety standards does not, standing alone, automatically insulate a defendant from punitive damages; it is a factor to be considered in determining whether punitive damages may be recovered.

Id. at 447.  Thus, a demand for punitive damages negates Sullivan I, since by definition punitive damages are all about a defendant’s conduct.  If bifurcation of punitive damages is at issue, should a product manufacturer’s conduct be presented in the first phase, standards compliance should be admissible as well.

Sixth, both Sullivan I and the three Supreme Court opinions are limited to the risk/utility theory of liability pursued by the plaintiff in that case.  Sullivan, OAJC, 2023 WL 8859656, at *9 (concluding that “evidence of industry standards is inadmissible under the risk-utility test in strict products liability cases”); at *10 (“compliance with industry or government standards is not admissible in design defect cases to show a product is not defective under the risk-utility theory”).  There remains a viable argument, post-Tincher, that standards compliance evidence may be admissible as to the other prong of Tincher’s “composite” design defect analysis, the consumer expectation test.  See Tincher, 104 A.3d at 402-03.

The consumer expectation argument was articulated in the earlier case, Estate of Hicks v. Dana Cos., 984 A.2d 943 (Pa. Super. 2009) (en banc), decided before Tincher adopted consumer expectations as a Pennsylvania design defect test.  As to consumer expectations, the en banc Hicks decision recognized that “evidence of wide use in an industry may be relevant to prove a defect because the evidence is probative, while not conclusive, on the issue of what the consumer can reasonably expect.”  Id. at 966.  While the risk/utility defect test predominates in Pennsylvania product liability litigation after Tincher, the Hicks argument remains available, should a plaintiff assert the consumer expectation prong.

Seventh, and finally, defendants seeking admissibility of FDA compliance evidence post-Sullivan should study the Donohue Concurrence carefully and augment the contents of their expert reports accordingly.  The Concurrence points out that the defendant’s expert’s report

[T]he range of factors that a jury would be instructed to consider were well known – the Wade Factors, the Barker Factors, and the . . . Pennsylvania Suggested Standard Jury Instructions.  [Defendants] did not attempt to establish the relevance of the applicable industry standards to any of the factors previously identified as relevant to the jury’s determination that a product is unreasonably dangerous.

Sullivan, Donohue Concurrence, 2023 WL 8859656, at *13 (footnotes omitted).  The Donohue Concurrence suggests that that standards compliance evidence could be admissible if the proponent (or the proponent’s expert):  (1) showed that the standard or regulation at issue is relevant to one or more of the factors juries consider in “determining whether the product at issue was unreasonably dangerous”; (2) placed the text of the standard or regulation in evidence; (3) established that the process by which the standard or regulation was created was unbiased; and (4) demonstrated that the purpose of the standard or regulation was safety related.  Id. at *13-16.

To avoid similar evidentiary problems with respect to FDA evidence, defense counsel should – particularly in cases in state court − have their experts address the relevance of FDA-related evidence to specific Wade and/or Barker factors in their reports, as well as the regulatory history of the FDA’s action.  Defendants should make detailed offers of proof in response to the other side’s expected in limine motions.  Defendants should anticipate adverse decisions the trial court level, because Sullivan I, and thus Lewis, remain controlling precedent.  Appellate preservation will also be critical.  See Schmidt v. Boardman Co., 11 A.3d 924, 942 (Pa. 2011) (requiring preservation of even “futile” arguments at each judicial level).

At least for the time being, Mallory ensures that Pennsylvania law and procedure will affect an outsized portion of prescription medical product liability litigation.  The Sullivan litigation, and the per se exclusionary rule against standards compliance evidence in Sullivan I, thus need to be on the radar of defense counsel in both prescription drug and prescription medical device cases.  Preservation of the 75-year-old line of Pennsylvania precedent that rejects strict liability in cases involving prescription medical products should be defense counsel’s “job one” in such litigation.

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We reported a few months ago on oral argument in the California Court of Appeal in Gilead Life Sciences v. Superior Court, where the parties argued about whether California law recognizes a broad “duty to innovate.”  At issue was whether a product manufacturer could be liable to patients taking one drug for failing to bring a different, but allegedly safer drug to market sooner than it actually did. 

The Court has now filed its opinion, and it’s not good.  The Court has ruled that a prescription drug manufacturer can owe such a duty, even when the plaintiffs have not alleged any defect in the drug that they actually used.  As the Court put it, “we conclude that the legal duty of a manufacturer to exercise reasonable care can, in the appropriate circumstances, extend beyond the duty not to market a defective product.”  Gilead Life Sciences, Inc. v. Superior Court, No. A165558, 2024 Cal. App. LEXIS 14 (Cal. Ct. App. Jan. 9, 2024) (to be published). 

To be sure, this is an expansion of California product liability law, which currently focuses on proof of a defect in the product.  But how did we get here?  The drugs at issue are life-saving antiretroviral drugs used to treat patients with HIV.  The defendant in Gilead has developed multiple drugs used to treat or prevent infection with the AIDS virus, including several containing tenofovir disoproxil fumarate (“TDF”).  That is the group of drugs that the plaintiffs allegedly used and that allegedly caused harmful side effects. 

By the time, however, the cases progressed to summary judgment, the plaintiffs were not claiming any defect in TDF.  Instead, the plaintiffs claimed that the defendant should have developed and marketed a different drug sooner.  The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later.  Plaintiffs now claim that TAF has a better safety profile compared to TDF and that the defendant unreasonably paused TAF’s development, thus depriving them of a drug that they say might have avoided their injuries.    

In other words, the plaintiffs were claiming that the defendant breached a duty to market TAF sooner, which we have been calling an unprecedented “duty to innovate.”  The Court of Appeal stated it somewhat more narrowly:

In context, then, the duty question we must address is whether a drug manufacturer, having invented what it knows is a safer, and at least equally effective, alternative to a prescription drug that it is currently selling and that is not shown to be defective, has a duty of reasonable care to users of the current drug when making decisions about the commercialization of the alternative drug.

Id. at *14.  The court ruled that a drug manufacturer owes this duty, but the purported “narrowness” of the duty is a recurring theme in the court’s opinion.  We will come back to that.

The court first addressed whether a product user can pursue a negligence claim for product liability without alleging a defect in the product.  This is a major issue.  Ever since Judge Cardozo found potential liability more than 100 years ago for that broken wooden wheel in MacPherson v. Buick, product liability has focused on a problem with the product.  The same has been true under California law since Justice Traynor took the baton in the 1940s, first in Escola v. Coca-Cola and later in Greenman v. Yuba Power Products.  These cases are not just relics from our first year of law school.  They form the foundation for product liability law as it stands today.

The Court of Appeal in Gilead took a different path and ruled that the plaintiffs could bring a garden-variety negligence claim without pleading and proving a defect in the TDF drugs that allegedly caused them harm.  According to the court, “a variety of cases demonstrate . . . that a manufacturer’s duty of reasonable care can extend more broadly than the duty to make a nondefective product, thereby permitting recovery even when there is no showing that the injury resulted from a product defect.”  Gilead, 2024 Cal. App. LEXIS at *19.  The “most prominent” example was Mexicali Rose v. Superior Court, 1 Cal. 4th 617 (1992), where the California Supreme Court held that a restaurant could be held negligent for harm caused by a chicken bone found in an enchilada, even though strict liability would not apply.  Gilead, at *19-*20.  The Court of Appeal took from Mexicali Rose that a plaintiff could recover under negligence “notwithstanding the plaintiff’s inability to prove a product defect.”  Id. at *21.    

Thus, in the court’s view, the plaintiffs’ negligence claim stood separate and apart from any problem with the TDF drugs that they used: 

Plaintiffs do not contend that [Defendant] was negligent because it made TDF available for sale, or because the risks of TDF outweighed its benefits.  Rather, they contend that [Defendant] breached its duty of reasonable care by postponing, solely to maximize profits, its effort to commercialize TAF . . . while continuing to market a medication with serious side effects that it knew TAF would have enabled patient to avoid.

Id. at *31-*32.  There are so many assumptions built into that gloss on the plaintiffs’ case, but the long and short is that the court viewed negligence and strict product liability as separate things, with a product defect being necessary for one (strict liability), but not the other (negligence).  In other words, “we conclude that plaintiffs’ negligence claim is not foreclosed by their decision to forgo any attempt to prove that TDF is defective.”  Id. at *38. 

Having concluded that the plaintiffs’ negligence claim was not foreclosed, the Court of Appeal applied the “foreseeability” and “public policy” factors that determine whether California law should impose a particular duty—known as the Rowland factors.  The parties disputed whether the Rowland factors applied at all (the defendant said they did not), and they further disputed whether the Rowland factors should determine when a “new duty” existed (the defendant’s argument) or when an “exception” existed to the general duty to avoid causing harm to another (the plaintiffs’ argument).  The court resolved these disputes in favor of the plaintiffs, thus flipping the burden and requiring the defendants to prove an “exception.”    

The court found that no exception to the general duty of care was warranted, and in this regard, the court’s factual assumptions are critical.  The plaintiff had to have alleged harm by a product currently on the market, and it was necessary to the court’s analysis that the same manufacturer developed both the current drugs and the alleged alternativeId. at *44.  In addition, the drug manufacturer had to have known that the alternative drug “was safer (and at least as effective) as the current drug.”  Id.  In ruling that injury was “foreseeable,” the court assumed “the existing drug creates identifiable and characteristic physical injury.”  Id at *48.  In discussing whether there was a “close connection” between the defendant’s alleged delay in developing TAF and the plaintiffs’ alleged injuries, the court accepted the plaintiff’s contention that the defendant knew that FDA approval of TAF would not be difficult. 

The court also assumed that physicians naturally would prescribe the “newer” TAF once the FDA approved it.  Id. at *48-*50.  Throughout the opinion, the court credited the plaintiff’s contentions that the defendant was “financially motivated” and conducted itself “solely to maximize profits.”  E.g., id. at *31, *32.  These issues will be contested if the case is allowed to proceed to trial (TDF remains FDA approved, on the market, and widely used), but at this point, the court’s many assumptions define the factual context in which this purported duty arises.  That is important. 

The Court of Appeal also ruled that public policy factors weighed in favor of imposing a duty.  The defendant bore some “moral blame,” even though it developed drugs that saved or extended the lives of hundreds of thousands of patients.  As the court saw it, “[m]oral blame is typically found when the defendant benefits financially from its conduct.” Id. at *52.  That mindset makes corporations (which exist to make a profit) always morally blameworthy.  In this case it meant that the defendant could be blamed for delay in marketing an allegedly better drug purportedly motivated by profit.  Id. at *51-*53.  The court also rejected the idea that this new duty would chill drug development by imposing a duty under which drug development decisions will be second guessed by juries 20 years in the future.  In this regard, the court paid short shrift to the California Supreme Court’s landmark opinion in Brown v. Superior Court, which rejected strict liability for alleged design defects in prescription drugs partly on the basis that public policy favored the development of new and beneficial drugs.  That same public policy weighs against the hindsight duty that the Court of Appeal created, but the court found it “unsupported.” 

So now we have this purported duty, and we have several additional observations about this opinion.  First, the court affirmed the denial of summary judgment on negligence, but ruled that the trial court should have granted summary judgment on fraudulent concealment.  Gilead, at *67-*71.  Whatever duties exist, they do not extend to the disclosure of facts related to TAF, which was not available as an alternative to TDF when these plaintiffs were treated. 

Second, the Court of Appeal allowed room for further development of the scope of the applicable duty on remand.  The defendant argued that if there were a duty to bring TAF to market sooner, the duty at least should not arise until after Phase III clinical trial data showed that TAF was safe and effective.  The court found this qualification to be unwarranted on the current record, but held that the defendant could renew the argument “based on a record developed later in the trial court, both before that court and, if necessary, on appeal from an adverse judgment.”  Id. at *61-*67. 

Third, the court was painstakingly clear that it was recognizing a narrow duty.  The court noted at the outset that it is “generally more appropriate to consider the claimed duty in its factual context,” and it followed by repeatedly emphasizing the facts and assumptions giving rise to the duty.  The court also stressed that the duty does not apply generally to “improved” products and that it does not require manufacturers to perfect their drugs, but “simply to act with reasonable care.”  We will see if this duty actually turns out to be “narrow,” as the Court of Appeal asserted.  We have serious doubts.  Under the negligence “duty” as construed by the court, any defendant who “knows” of an allegedly safer and equally effective design for a product it currently makes will be compelled to replace its existing product with the alternative design, or else face a risk of liability.  This novel duty has implications far beyond FDA-regulated products.

Fourth, we still have difficulty reconciling this duty with existing product liability law, even as “narrowly” construed.  For one thing, if the standard is actual knowledge, is this even a negligence claim anymore?  We’re not sure what the claim would be.  Warranty?  An intentional tort?  But to return to our major theme, the Court of Appeal has departed from the core concept that product liability, whether sounding in negligence or in strict liability, depends on a problem with the product—a defect.  Heck, even in Mexicali Rose, the alleged negligence—failure to remove a chicken bone—was in connection with preparation of the enchilada that harmed the plaintiff.  Here, the plaintiffs allege that TDF harmed them, but they disavow any defect in the product itself and they allege negligence in connection with a different product.  (And can we say finally that prescription drugs are not the least bit comparable to chicken enchiladas.) 

Fifth, if these plaintiffs have a claim, we still see problems with causation.  The Court of Appeal minimized the causation hurdles of FDA approval and the need for physicians to prescribe the newer TAF drugs instead of TDF, but again we are not so sure.  It will be a tough row to hoe for any plaintiff to prove that the FDA would have approved TAF drugs in time to make a difference; that his or her doctor would have prescribed TAF instead of TDF, especially if the patient was doing just fine with the earlier product; and that switching from TDF to TAF would actually have prevented his or her alleged injuries.  The plaintiffs should not be allowed to get that far with these claims, but if they do, they have an uphill climb. 

In the end, the Court of Appeal invoked the plaintiffs’ use of TDF to find a duty in connection with the defendant’s development of a different drug.  That is unprecedented, and we will repeat our admonition that it is unnecessary.  These plaintiffs have product liability claims against this defendant, provided they can plead and prove the essential elements.  The mere fact that they could not do it does not warrant creating a whole new claim.  We presume a petition for review to the California Supreme Court is forthcoming. 

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Much of the Camp Lejeune litigation is rapidly becoming, in military parlance, FUBAR.  Even prominent plaintiff-side lawyers have started calling out the avalanche of fraudulent claims that MDL-style solicitation has been generating.  Congress permitted liability, so now the United States itself is being targeted by the same litigation practices that plague MDL defendants.

But the United States has some advantages that other litigants lack (besides the ability literally to print money).  Anybody who might attempt to obtain similar discovery from the FDA in a prescription medical product case, take note.

In In Re: Camp Lejeune Water Litigation, 2023 WL 8791671 (E.D.N.C. Dec. 19, 2023), the plaintiffs sought “to compel production of a draft Cancer Incidence Study (CIS)” from a federal agency before it had been published.  Id. at *1.  Instead, they received a judicial Alpha Charlie.  That’s because of something called the “deliberative privilege.”

Basically, the Camp Lejeune litigation is about allegations (often overblown) of exposure to carcinogenic substances.  Thus, an official study “to determine whether residential workplace exposures to the drinking water contaminants at Camp Lejeune are associated with increased risks of specific cancers,” id., is likely to be a big deal in this litigation and could well be fatal to many of the bogus claims now being filed.  That best explains why the Camp Lejeune plaintiffs wanted to jump the gun and demanded access before the study was finished.

It also explains why the plaintiffs’ motion to compel was forcefully denied.  Prior to the study’s intended public release, documents and information concerning the study were protected from civil discovery by the government’s deliberative process privilege – and if this federal agency enjoys that privilege, then the FDA probably does, too.  Lejeune described the deliberative process privilege:

The privilege “rests on the obvious realization that officials will not communicate candidly among themselves if each remark is a potential item of discovery and front page news, and its object is to enhance the quality of agency decisions by protecting open and frank discussion among those who make them within the Government.”

Lejeune, 2023 WL 8791671, at *2 (quoting Dep’t of the Interior v. Klamath Water Users Protective Assn., 532 U.S. 1, 8-9 (2001)) (internal quotations omitted).  Even “purely factual information” is protected when “inextricably intertwined with deliberative material.”  Id. (citation and quotation marks omitted).

Lejeune held that all the documents that plaintiffs sought were privileged.  They were “deliberative” because not only were they required by law, but the law demanded that such studies “‘shall be reported or adopted only after appropriate peer review.’” Id. at *3 (quoting statute).  Peer review in this instance requires “multiple reviews” and approval from not one, but two, government agencies.  Id.  Everything plaintiffs were seeking had been “prepared to help the agency formulate its position, specifically, to publish” a hypothetical final CIS.  Id. (citation and quotation marks omitted).  That included the study data itself:

[T]he data and analytical files are part of the deliberative review and intertwined with the Cancer Incidence Study’s analysis.  Release of the data would reveal much of the agency’s deliberation about the study findings. The collection and management of this data is also intertwined in the ATSDR study authors’ preliminary analysis and draft conclusions.

Lejeune, 2023 WL 8791671, at *4 (citation and quotation marks omitted).  The data, and the government’s analysis of it, were “inextricably intertwined.”  Id.

The privilege also applied because all the documents were “predecisional” – the study had not yet passed the government’s review.  Id.  The study was “undergoing [agency] review currently,” and its contents could “change substantially before the review is complete.”  Id.  That could well be precisely why plaintiffs were trying to interfere with the process, but that is also precisely the sort of extraneous influence that the deliberative process privilege was intended to prevent.  “The privilege is about preserving the deliberative process itself.”  Id. at *2.

The deliberative process privilege is qualified, but in Lejeune the information at issue fully qualified.  The information was “plainly relevant,” but “Plaintiffs have access to multiple other studies linking exposure to the toxic chemicals . . . with various diseases and health effects.”  Id. at *5.  The plaintiffs desire to look over the scientists’ shoulders “weighs heavily in favor” of the privilege.  Id.

[R]eleasing the non-final CIS would suppress the routine scientific review process and have a chilling effect on deliberations.  That scientific review is mandated by statute and involves multiple independent experts . . . to protect the scientific process and integrity of the study to be published.

Id. (citations and quotation marks omitted).  Given that “tens of thousands of individuals may be implicated by” the CIS, the pressure that premature release could create is cause for “[c]oncern for the integrity of the scientific review process.”  Id. at *5-6.  In addition, “compelling production of an incomplete CIS subject to change” could result in “public confusion” – likely generated by plaintiffs’ reacting loudly to anything they didn’t like – and could “undermine the public’s trust in and credibility.”  Id. at *6.

For all these reasons, the Camp Lejeune plaintiffs’ motion to compel premature release of information relating to the cancer study was rejected. 

The same privilege should protect the FDA from similar impositions.  While occasionally defendants also need information from the FDA, See, e.g., In re Phenylpropanolamine, MDL NO. 1407, slip op. (W.D. Wash. Nov. 12 2003), as a practical matter only plaintiffs would be likely to do so abusively.  Defendants:  (1) must consider their ongoing relationship with the agency that regulates them, (2) rarely seek to overturn FDA actions in product liability litigation, and (3) mostly want backward-looking regulatory history information available through the Freedom of Information Act.

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Our work on “hard goods” (automobile, appliance, fire) product liability cases is greatly outnumbered by our drug and device cases (and probably also outnumbered these days by website privacy cases).  But the history of product liability has often been driven by such hard goods cases.  Think of Cardozo’s famous opinion in MacPherson v. Buick.

Today’s case, Ford Motor Co. v. Tyler, 2023 W. Va. App. LEXIS 337, 2023 WL 8588042(W.Va. Ct. App. Dec. 8, 2023), is obviously not a prescription medical product case, but rather an automotive case.  Still, the question it decides affects prescription medical product (particularly device) cases.  It also extensively discusses (and disagrees with) a pro-plaintiff ruling in the dreaded Pelvic Mesh MDL.  The issue is whether West Virginia law requires proof of an alternative design in negligent design defect cases.

Tyler involved a fatal car accident.  One of the plaintiff’s theories was that the design of the brake fluid reservoir was defective because it was inadequately protected, permitting the release of brake fluid after a collision, thereby igniting a fire. (There was another defect theory, which was ultimately rejected by the jury.) The plaintiff filed two claims on this theory: strict liability design defect and negligent design defect.  After the close of evidence, at the charge conference, the trial court said it would instruct the jury that the strict liability design defect claim required the plaintiff to show the existence of a safer alternative design.  So far so good. But the trial court refused the defendant’s request for a similar instruction for the negligent design defect claim.  The trial court acknowledged that most courts around the country would include that requirement, but the trial court was swayed by a decision in the West Virginia Pelvic Mesh MDL that a safer alternative design was not required in negligence claims.  (The Pelvic Mesh MDL really is the gift that keeps giving … nightmares to defense lawyers.) The plaintiff in Tyler then dropped the strict liability design defect claim.  That meant that the jury heard not a word regarding safer alternative design.  The plaintiff’s ploy worked, because the jury returned a significant verdict in the plaintiff’s favor on the negligent design claim.  

The defendant then filed a motion for judgment as a matter of law or, in the alternative, for a new trial.  The main argument in the motion was that the trial court should have instructed the jury that the plaintiff could not prevail on negligent design unless there was a safer alternative design.  The trial court denied the motion, and the issue went up to the West Virginia intermediate appellate court.

The Tyler appellate court analyzed the issue by taking an extensive tour of both West Virginia product liability law and the law in general as to whether claims for negligent design require a safer alternative.  We wrote an extensive blogpost on that latter point.  To be sure, that post was largely prompted by the way the Pelvic Mesh MDL made a hash of the issue.  Not only did the Pelvic Mesh MDL judge drop the safer alternative requirement from negligent design, but in the Shears case the Fourth Circuit subsequently sought guidance from the West Virginia Supreme Court as to whether a safer alternative was required in strict liability claims. As we discussed in a prior post, the issue is currently pending before the West Virginia high court.  One trembles.  

The Tyler appellate court treats us to a thorough and persuasive discussion of West Virginia law, the Third Restatement of Torts (which requires a safer alternative for both strict liability and negligent design defect) and other state law.  In the end, the (relatively new) West Virginia intermediate appellate court agreed with the “vast majority of states” and required an alternative design in negligent design cases. That meant that the Tyler appellate court explicitly disagreed with the Pelvic Mesh MDL decision.  But it did so in as polite and gentle a way as possible: “While we conclude that Judge Goodwin incorrectly interpreted West Virginia law, he himself even acknowledged that an alternative feasible design will always be relevant in determining if a product was designed negligently.”  That’s nice, we suppose.  

What was the plaintiff’s rationale for omitting the safer alternative requirement from the negligent design defect claim?  It was the same rationale employed by the Pelvic Mesh court in getting the issue wrong.  Here is how the reasoning goes:  strict liability is about whether the product is unreasonably dangerous, whereas negligence is about the defendant’s conduct.  On a superficial level, that sounds like a meaningful distinction.  But as the Third Restatement, cases from that “vast majority” of other states, and, for that matter, the West Virginia Supreme Court in the Stone case demonstrated, one cannot cogently assess a defendant’s reasonableness in designing a product without assessing the availability of safer alternatives.  The Tyler court could not “conceive of a factual scenario where an alternative feasible design would not be a necessary element in finding that the defendant was negligent in a design defect claim.”  (We share that position. Why should a defendant be found liable for a design when even the enterprising plaintiff lawyer or expert cannot suggest an improvement?)

Thus, the intermediate appellate court in Tyler allied itself with the Third Restatement, “vast majority” of jurisdictions, and logic in requiring a safer alternative for negligent design claims.  It was, therefore, error by the trial court in Tyler not to instruct the jury on the nature of this requirement, and the defendant was entitled to a new trial.  We can only hope that this decision is persuasive to the West Virginia high court in the medical device case before it.