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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.