As we mentioned at size in this put up, because the Forties, the Pennsylvania Supreme Court docket and different courts making use of Pennsylvania regulation have refused to topic prescription medical merchandise to strict legal responsibility.  That’s vital as a result of, in contrast to (now) each different state within the nation, since 1987 Pennsylvania precedent prohibited defendants from introducing proof of their compliance with authorities and/or business requirements (“requirements compliance” or “compliance” proof, for brief) in strict legal responsibility design defect circumstances – usually.  There was appreciable hypothesis that the seminal case, Lewis v. Coffing Hoist Division, 528 A.2nd 590 (Pa. 1987), might not management as a result of it was based mostly on a peculiarly strict method to strict legal responsibility – what we name a negligence/strict legal responsibility dichotomy − that the Pennsylvania Supreme Court docket appeared to have overruled and rejected in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014).  Neither Lewis nor Tincher concerned prescription medical merchandise, however reasonably what we describe as “issues that go clank.”

Nevertheless, Pennsylvania’s intermediate appellate court docket determined in any other case in Sullivan v. Werner Co., 253 A.3d 730 (Pa. Tremendous. 2021), aff’d by an equally divided court docket, 2023 WL 8859656 (Pa. Dec. 22, 2023) (“Sullivan I”), one other resolution not involving prescription medical merchandise.  Sullivan I held that, beneath Pennsylvania’s interpretation of Restatement (Second) of Torts §402A (1965):

[I]t is irrelevant if a product is designed with all doable care, together with whether or not it has complied with all business and governmental requirements, as a result of the producer remains to be liable if the product is unsafe. . . .  Beneath such reasoning, proof of business requirements could also be excluded as a result of these requirements don’t go to the protection of the product itself however to the producers’ “doable care in preparation of product,” which is irrelevant as to if a product is unsafe or strict legal responsibility is established.

Id. at 747 (quotation omitted).  The Superior Court docket panel thus discovered no abuse of discretion within the exclusion of requirements compliance proof in a strict legal responsibility design defect case.

Sullivan I was appealed to the Pennsylvania Supreme Court docket.  A few months after Sullivan I, the Third Circuit licensed a different-but-related query to the Pennsylvania Supreme Court docket:

Beneath Pennsylvania regulation, are prescription implantable medical gadgets categorically topic to strict legal responsibility, categorically immune from strict legal responsibility, or immune from strict legal responsibility on a case-by-case foundation?

Ebert v. C.R. Bard, Inc., 2021 WL 2656690, at *6 (3d Cir. June 24, 2021).  The Pennsylvania court docket accepted the licensed query.  Ebert v. C.R. Bard, Inc., 260 A.3d 81 (Pa. 2021).  Nevertheless, Ebert settled and not using a resolution.  See Ebert v. C.R. Bard, Inc., 2021 WL 9950511 (3d Cir. Nov. 10, 2021) (granting unopposed movement to dismiss pursuant to settlement).

We mentioned the Ebert enchantment right here as a result of plaintiff-side amici in Ebert had repeatedly misrepresented to each the Third Circuit, after which to the Pennsylvania Supreme Court docket, that Creazzo v. Medtronic, Inc., 903 A.2nd 24 (Pa. Tremendous. 2006) – a precedential holding that the identical Pennsylvania rule barring strict legal responsibility claims in opposition to prescribed drugs additionally utilized to prescription medical gadgets − shouldn’t be adopted as a result of the plaintiffs in Creazzo have been supposedly “professional se.”  That was false, based mostly on a printer’s error, and that error has now been corrected.  However within the interim, plaintiffs did handle to hawk that falsehood efficiently to 4 federal district judges, as our put up detailed.

Effectively, Sullivan I has now been affirmed, form of.  First, full disclosure, Bexis dealt with the protection facet of the Pennsylvania Supreme Court docket enchantment in Sullivan.  The rationale we are saying “form of” is that the Pennsylvania excessive court docket didn’t affirm with any precedential order or opinion.  Three of the six sitting justices – not a majority − held that, however Tincher, the prior bar to admissibility of requirements compliance proof ought to stay.  “We conclude that proof of compliance with business requirements is inadmissible beneath the risk-utility take a look at in strict merchandise legal responsibility circumstances. On this regard, we reaffirm the post-Tincher validity of the rule introduced in Lewis.”  Sullivan v. Werner Co., 2023 WL 8859656, at *9 (Pa. Dec. 22, 2023) (Opinion Asserting the Judgment of the Court docket (“OAJC”)).  The OAJC didn’t contemplate choices of governmental or standards-setting organizations to be related to strict legal responsibility:

[C]ompliance proof is solely proof of the last word conclusion {that a} product complies with authorities laws or business requirements, i.e., {that a} authorities company or business group would deem the product not faulty.  It’s not proof of the underlying attributes of the product that make it compliant with laws or requirements, which is presumably admissible topic to the strange Guidelines of Proof.  We agree with the Lewis Court docket’s evaluation that the main target of a design defect case should be restricted to the traits of the product, and never the conduct of the producer or vendor.

Id., OAJC, 2023 WL 8859656, at *11.  “That OSHA or ANSI would deem a defendant’s conduct compliant with its requirements shouldn’t be related to the risk-utility take a look at and diverts the jury’s consideration from the related inquiry.”  Id.  Lastly, the OAJC was not involved with Pennsylvania being a “minority” of 1 (Montana, the one different holdout, having flipped whereas Sullivan was pending) in excluding requirements compliance proof in strict legal responsibility circumstances.

Appellants’ argument that our resolution locations Pennsylvania in a minority place relating to the inadmissibility of compliance proof is unavailing.  Our resolution relies on our evaluation and utility of Pennsylvania precedent relating to the event of strict product legal responsibility.  We adhere to Part 402A’s precept that strict legal responsibility could also be imposed even when a defendant exercised “all doable care”. . . .  It displays the “social and financial coverage of this Commonwealth.”

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

A fourth Justice concurred within the consequence, treating the problem of requirements compliance in Sullivan as a matter of proof, and holding that the dearth of a ample trial file supporting the relevance of the particular requirements at subject in Sullivan meant that the trial decide’s exclusion was not an abuse of discretion.

Based mostly on the file on this case developed on [plaintiffs’] Movement in Limine . . . and [defendants’] response thereto, the trial court docket didn’t abuse its discretion by disallowing the proof.  For my part, the difficult authorized subject introduced on this enchantment is sadly not resolvable due to the undeveloped evidentiary file and undirected advocacy within the trial court docket.

Sullivan, Donohue Concurrence within the consequence, 2023 WL 8859656, at *13.  This opinion was took a “extra nuanced” view of the admissibility of requirements compliance proof in strict legal responsibility, id., and accepted the defendants’ “workable” argument that “producing a product that’s designed pursuant to the business or authorities customary makes proof of the usual related to the query of whether or not the product is flawed.”  Id.  However within the view of this Justice, the trial file lacked ample proof to overturn the trial decide’s exclusion.  “[T]he jury was instructed to contemplate quite a lot of components in figuring out whether or not the product at subject was unreasonably harmful” however defendants “didn’t try to determine the relevance of the relevant business requirements to any of [those] components.”  Id.

Nor have been the precise requirements at subject within the file (since that they had been excluded in limine).  “From the outset, I used to be struck by the omission from the file of the particular ANSI or OSHA customary sought to be admitted.”  Sullivan, Donohue Concurrence, 2023 WL 8859656, at *14.  “[B]aldly stating {that a} product complied with [relevant] requirements is meaningless to a court docket tasked with figuring out the relevancy of the proof,” so exclusion in Sullian was not an abuse of discretion.  Id. at *15.  “A trial court docket could be inside its train of discretion to exclude the proof if it concluded {that a} sub-trial on the load to be given to [the] requirements would confuse the jury and warp the main target from the product at subject.”  Id. at *16.

Lastly, two Justices dissented, taking the view that requirements compliance proof ought to usually be admissible in strict legal responsibility, as it’s in each different state within the nation.

[U]nder Pennsylvania’s broad relevancy guidelines, governmental and business requirements ought to be admissible in merchandise legal responsibility design defect issues.  Moreover, the overwhelming majority of our sister states discover governmental and business requirements proof to be admissible. . . .  [T]he OAJC’s exclusion of governmental and industrial requirements to defend in opposition to a faulty product declare, at its core, displays a distrust of our jury system and suggests juries can not perceive these complicated issues. . . .  Our total jury system depends upon the adversarial presentation of proof and argumentation. It ought to be no completely different within the space of merchandise legal responsibility.

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

Thus, in a Pennsylvania strict legal responsibility motion, a paid plaintiff’s professional might provide a design defect opinion based mostly on untested and untried “options,” whereas the thought-about judgment of governmental {and professional} requirements setting organizations shouldn’t be even admissible.  So what now, and specifically how does Sullivan impression prescription medical product legal responsibility litigation? 

First, the none of what you simply learn in regards to the Supreme Court docket resolution in Sullivan is precedential in Pennsylvania.  The Pennsylvania Supreme Court docket cut up 3-3 on the core query of whether or not requirements compliance proof is categorically inadmissible in strict legal responsibility circumstances.  The one binding precedent in Sullivan is the Superior Court docket’s resolution, which adopted the per se exclusionary rule as a result of compliance proof is “irrelevant as to if a product is unsafe or strict legal responsibility is established,” Sullivan I, 253 A.3d at 747, and it was as much as the excessive court docket to vary the rule it created.  Id. (whereas “our Supreme Court docket might permit business and governmental requirements . . ., till it does, Tincher neither explicitly nor implicitly overrules the exclusion”).

This final result in Sullivan enormously will increase the significance of Pennsylvania’s aforementioned rule usually making use of Restatement (Second) of Torts §402A, remark ok (1965), to preclude strict legal responsibility (besides conceivably for manufacturing defects) in opposition to producers of prescription medical merchandise.  Tincher itself acknowledged this exception to strict legal responsibility.

No product is expressly exempt [from strict liability] and, consequently, the presumption is that strict legal responsibility could also be accessible with respect to any product, offered that the proof is ample to show a defect . . .; however see Hahn v. Richter, 543 Pa. 558, 673 A.2nd 888 (1996) (producer immune from strict legal responsibility faulty design declare premised upon sale of prescribed drugs with out sufficient warning).

Tincher, 104 A.3d at 382 (different citations omitted).  As mentioned above, this rule has been beneath assault in medical machine circumstances, largely in federal courts (who haven’t any enterprise, beneath Erie, increasing legal responsibility beneath Pennsylvania regulation), and in at the very least in 4 circumstances as a consequence of p-side misrepresentations regarding the Creazzo precedent.

We’ve got mentioned how exclusion of FDA compliance in pelvic mesh circumstances, based mostly on a false equivalence between preemption and evidentiary admissibility, has hampered the protection in that litigation.  You possibly can wager your backside greenback that, ought to prescription medical merchandise (or any class of them) be subjected to “strict legal responsibility” in Pennsylvania, plaintiffs will search to exclude FDA compliance proof in all circumstances involving such merchandise.  In state court docket, Creazzo stays binding precedent.  In federal court docket Creazzo isn’t technically binding, however precedential intermediate appellate choices are by far probably the most persuasive proof foundation for an Erie prediction – exactly why plaintiffs constantly misrepresented Creazzo as a “professional se” case in federal court docket.

Thus, it’s vital post-Sullivan to take care of Pennsylvania’s well-recognized and long-standing prescription medical product exception to strict legal responsibility.  We provide our prior complete put up on this topic.  Particularly, defendants in medical machine circumstances ought to depend on the ignored resolution in Cafazzo v. Central Medical Well being Providers, Inc., 668 A.2nd 521 (Pa. 1995), which precluded strict legal responsibility allegations in a prescription medical machine case:

In Cafazzo, the plaintiff unsuccessfully sought to carry a hospital strictly liable as an intermediate vendor of an allegedly faulty a jaw implant.  The court docket refused to use strict legal responsibility, holding “that even when [defendants] could possibly be proven to have ‘marketed’ the prosthesis, strict legal responsibility doesn’t apply.”  Id. at 523.  The no-fault, cost-shifting “coverage” of strict legal responsibility didn’t justify changing claims in any other case sounding in negligence to strict legal responsibility.  “To assign legal responsibility for no motive aside from the flexibility to pay damages is inconsistent with our jurisprudence.”  Id. at 526 (quotation omitted).  “[R]esearch and innovation in medical tools and therapy could be inhibited.”  Id. at 527.  Cafazzo subsequently refused to increase strict legal responsibility.

[B]efore a change within the regulation is made, a court docket, whether it is to behave responsibly should have the ability to see with affordable readability the outcomes of its resolution and to say with affordable certainty that the change will serve one of the best pursuits of society. . . .  It’s . . . not clear sufficient that strict legal responsibility has afforded the hoped for panacea within the typical merchandise space that it ought to be prolonged so cavalierly in circumstances comparable to the current one.

Id. at 527 (quotation and citation marks omitted).  Thus, Creazzo shouldn’t be the one Pennsylvania appellate resolution rejecting strict legal responsibility in opposition to medical gadgets – the Pennsylvania Supreme Court docket has additionally rejected strict legal responsibility in such circumstances (albeit in opposition to a hospital defendant), and we must always say so.

Second, defendants shouldn’t let plaintiffs sneak their very own negligence-based arguments into strict legal responsibility circumstances.  Plaintiffs wish to insert what the Sullivan OAJC would contemplate “conduct” based mostly proof and argument into what they nonetheless name “strict legal responsibility.”  Frequent allegations of this type are “failure to check,” “failure to recall,” “failure to report” opposed occasions to the FDA, and “per se” legal responsibility for purported FDCA violations.  Pennsylvania, nonetheless, acknowledges solely “three several types of faulty situations that may give rise to a strict legal responsibility declare: design defect, manufacturing defect, and failure-to-warn defect.”  E.g., Sullivan, OAJC, 2023 WL 8859656, at *2 n.1 (quoting Phillips v. A-Greatest Merchandise Co., 665 A.2nd 1167, 1170 (Pa. 1995).  Extra theories, asserting legal responsibility grounded in alleged deficiencies in testing, recall, or reporting procedures, or as a result of a defendant purportedly broke some regulation, are based mostly on that producer’s claimed conduct, and subsequently sound in negligence – to the extent that Pennsylvania regulation would acknowledge them in any respect (which the above hyperlinks reveal is usually not the case).  A plaintiff’s pursuit of such theories thus ought to permit admission of requirements compliance proof.

An illustrative instance is Hrymoc v. Ethicon, Inc., 297 A.3d 1245 (N.J. 2023), a pelvic mesh case the place exclusion of FDA compliance proof was held error, even beneath an abuse of discretion customary, as a result of the plaintiff harped on an alleged failure to check after profitable exclusion, and thus prevented the defendant from countering that the selfsame product exams plaintiffs have been demanding weren’t required by the FDA:

[I]t was unfair for the trial court docket to not permit [defendant] to elucidate in response that it obtained 510(ok) clearance to market the gadgets with out scientific research or trials.  Certainly, in making [defendant’s] failure to conduct scientific trials or research of the [product] a central theme of their case, plaintiffs “opened the door” to the admission of 510(ok) proof, however the trial court docket’s exclusion.

Id. at 1261 (quotation omitted).

What’s sauce for the goose ought to be sauce for the gander.  If compliance proof is excluded in Pennsylvania as “negligence” or “conduct” proof, then plaintiffs ought to likewise be precluded in strict legal responsibility circumstances from making claims based mostly on a defendant’s conduct, reasonably than the precise situation of the product. Similar to we did earlier than Tincher, we have to be objecting early and sometimes to plaintiffs’ makes an attempt to disguise negligence claims and conduct proof as “strict legal responsibility,” together with the submitting of applicable motions in limine targeted on plaintiffs thereby opening the door to our use of requirements compliance proof.

Third, and considerably associated to the second level, because the dissent in Sullivan identified, pre-Tincher Pennsylvania regulation utilized the bar to requirements compliance proof erratically, primarily giving plaintiffs free reign to “open the door” to such proof every time they discover it useful to their case:

[G]overnmental and business requirements are admissible in a plaintiff’s case.  Gaudio v. Ford Motor Co., 976 A.2nd 524, 544 (Pa. Tremendous. 2009).  For my part, it’s patently unfair to permit such requirements into proof in a plaintiff’s case, however not within the protection’s case.  If proof of governmental and business compliance was irrelevant to strict legal responsibility, then such proof ought to be inadmissible for each plaintiff and defendant alike.

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

True, Gaudio does so maintain.  However whether or not that one-way door stays good regulation is unclear after Sullivan.  The precedential Superior Court docket resolution didn’t deal with that side of Gaudio, focusing solely on Gaudio’s growth of Lewis to embody authorities, in addition to business, requirements.  Sullivan I, 253 A.3d at 741, see id. at 748 n.10 (expressly “not deal with[ing]” any door opening subject).  In response to the Sullivan dissent’s harsh criticism of plaintiffs, however not defendants, having the ability to admit standards-related proof, neither the OAJC nor the Donohue Concurrence defended the Superior Court docket’s pre-Tincher door-opening precedent.

The OAJC’s view of requirements compliance proof, furthermore, suggests  that “door opening” might not be applicable.  Compliance was merely “the last word conclusion {that a} product complies with authorities laws or business requirements,” and “not proof of the underlying attributes of the product.”  Sullivan, OAJC, 2023 WL 8859656, at *11.  If, because the OAJC posits, “[c]ompliance proof doesn’t show any attribute of the product,” however as an alternative “diverts [the jury’s] consideration” to issues not “pertinent to” a design defect declare,” id., then the identical proof shouldn’t be related to a plaintiff’s case both.  The OAJC references not solely “the producer’s conduct,” but in addition “whether or not a standards-issuing group would contemplate the product to be freed from defects.”  Id.  Consequently, whether or not a product did not adjust to the identical customary would equally “divert” the inquiry, and “whether or not a standards-issuing group would contemplate the product to be freed from defects” would logically be equally related, or not, whether or not the reply to that query is “sure” or “no.”

Thus, whereas Gaudio stays binding precedent, the logical and authorized foundation for permitting a plaintiff to confess non-compliance proof primarily at will is questionable post-Sullivan, and never a single member of the Pennsylvania Supreme Court docket appeared keen to defend the follow.  Going ahead, this is a matter that defendants ought to strongly contemplate preserving.

Fourth, how will battle of regulation ideas have an effect on utility of the Pennsylvania exclusionary rule?  There are two points to this query, they usually doubtlessly lower in numerous instructions.  As primarily everybody now is aware of, Mallory v. Norfolk Southern Railway Co., 600 U.S. 122 (2023), upheld in opposition to a Due Course of problem a novel Pennsylvania statute that imposes basic private jurisdiction on any Pennsylvania-registered international company.  Pennsylvania is a comparatively massive state, so most (if not all) main product producers are so registered.  Thus (except and till the Dormant Commerce Clause places a cease to it) any plaintiff anyplace within the nation can sue Pennsylvania-registered drug or machine producers in Pennsylvania courts.

One query is thus whether or not Pennsylvania’s per se ban on requirements compliance proof is “substantive” or “procedural” (that shorthand is definitely a minefield) for selection of regulation functions with respect to Mallory progeny circumstances that in any other case should apply different states’ “substantive” regulation.  The second query entails one other model of the “substantive”/“procedural” divide, this time between state and federal courts, each making use of Pennsylvania regulation.  This query is an utility of Hanna v. Plumer, 380 U.S. 460 (1965), since in federal court docket the admissibility of proof is ruled by the Federal Guidelines of Proof.  E.g., Rolick v. Collins Pine Co., 975 F.2nd 1009, 1013 (3d Cir. 1992).

These two questions can result in completely different outcomes.  Taking the second first, in Rollick, the Third Circuit held that the admissibility of requirements compliance usually (not in a strict legal responsibility case) is ruled by the relevance requirements of the Federal Guidelines of Proof, not by Pennsylvania regulation.  The Third Circuit has already held that admissibility of requirements compliance proof in Pennsylvania-law variety circumstances is ruled by the relevance requirements of the Federal Guidelines of Proof.  See Covell v. Bell Sports activities, Inc., 651 F.3d 357, 366 (3d Cir. 2011) (federal guidelines “management on this case as a result of they’re ‘arguably procedural’”)

The difficulty to be determined right here is whether or not the OSHA regulation is admissible in a variety motion as proof of the usual of care owed by the defendants to the plaintiff. . . .  Because the query entails the admission of proof in a federal court docket, the Federal Guidelines of Proof management. . . .  We are able to consider no motive beneath the Federal Guidelines of Proof why the OSHA regulation shouldn’t be related proof of the usual of care as soon as it’s decided, as we’ve got performed, that beneath Pennsylvania regulation the defendants may owe plaintiff an obligation of care. . . .  [We] “borrow” the OSHA regulation to be used as proof of the usual of care owed to plaintiff.

Rolick, 975 F.2nd at 1013-14.  Equally, in Forrest v. Beloit Corp., 424 F.3d 344, 354 (3d Cir. 2005), the court docket (pre-Tincher) held that admissibility of proof of lack of comparable occurrences was a procedural query ruled by the federal guidelines in variety circumstances, not by an on-point Pennsylvania Supreme Court docket resolution:

Whereas the well-reasoned resolution [of the Pennsylvania Supreme Court] offers helpful steerage, the query introduced is ruled by federal reasonably than state regulation.  The admissibility of the proof finally activates a balancing of its probative worth versus its prejudicial impact, and we’ve got held that in a federal court docket the Federal Guidelines of Proof govern procedural problems with 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 legal responsibility case; “evaluation of the risks of unfair prejudice and confusion of the problems are procedural issues that govern in a federal court docket however a state coverage on the contrary”); Kelly v. Crown Tools Co., 970 F.2nd 1273, 1278 (3d Cir. 1992) (federal rule admitting subsequent remedial measures “is ‘arguably procedural,’ and subsequently governs on this variety motion however Pennsylvania regulation on the contrary”).  Thus, controlling Third Circuit precedent would require, post-Sullivan, that Pennsylvania’s per se exclusion of requirements compliance proof not apply in federal court docket, given the liberal relevance requirements of Fed. R. Civ. P. 401 and 402.

Nevertheless, there’s language within the Sullivan OAJC that plaintiffs may use to say that the exclusionary rule is a matter of substantive Pennsylvania regulation.  As we’ve already mentioned, the OAJC said that requirements compliance “shouldn’t be proof of the underlying attributes of the product . . ., which is presumably admissible topic to the strange Guidelines of Proof.”  2023 WL 8859656, at *11.  That means that Pennsylvania substantive regulation locations limits on compliance proof past the scope of, at the very least, Pennsylvania’s evidentiary guidelines.  Equally, the closing paragraph embracing the “minority place” invokes “the social and financial coverage of this Commonwealth” as grounds to maintain requirements compliance proof away from Pennsylvania jurors.  Id. at *12.  We additionally observe that Lewis itself predates the adoption of the Pennsylvania Guidelines of Proof.

We current either side of this subject as a result of the opposite selection of regulation query:  what regulation applies to Mallory progeny circumstances the place different states’ legal guidelines would in any other case govern, raises opposite issues.  Pennsylvania procedural guidelines – however not Pennsylvania substantive regulation – apply in Pennsylvania courts.  E.g., Commonwealth v. Sanchez, 716 A.2nd 1221, 1223 (Pa. Tremendous. 1998).  We haven’t seen requirements compliance litigated, however T.M. v. Janssen Prescription drugs, Inc., 214 A.3d 709 (Pa. Tremendous. 2019), analogously held that the usual for admission of professional testimony was “procedural” and subsequently Pennsylvania’s Frye rule utilized, not Texas’ stricter professional admissibility customary.  Id. at 721-22.  It additionally seems that, in contrast to the OAJC, the Donovan Concurrence treats the problem as procedural, because it employed the abuse of discretion customary relevant to evidentiary rulings, reasonably than the de novo customary governing authorized questions that the OAJC used.

Thus, in articulating their positions following Sullivan, protection counsel want to contemplate rigorously the variations and similarities between these two “substance”/”process” exams – recognizing that what is taken into account “substantive” and what’s “procedural” has the potential to have an effect on the appliance of Sullivan I’s post-Tincher exclusionary rule in another way.  To the extent that courts deem the 2 purposes of “substance” versus “process” analogously, what restricts the exclusionary rule in a single state of affairs, might effectively increase it within the different.

Fifth, if a plaintiff is searching for punitive damages, requirements compliance proof is admissible however “strict legal responsibility” being the underlying explanation for motion.  The Pennsylvania Supreme Court docket so held in Phillips v. Cricket Lighters, 883 A.2nd 439 (2005):

[A]t the time this [product] was offered, it complied with all security requirements.  After all, compliance with security requirements doesn’t, standing alone, robotically insulate a defendant from punitive damages; it’s a issue to be thought-about in figuring out whether or not punitive damages could also be recovered.

Id. at 447.  Thus, a requirement for punitive damages negates Sullivan I, since by definition punitive damages are all a few defendant’s conduct.  If bifurcation of punitive damages is at subject, ought to a product producer’s conduct be introduced within the first section, requirements compliance ought to be admissible as effectively.

Sixth, each Sullivan I and the three Supreme Court docket opinions are restricted to the chance/utility concept of legal responsibility pursued by the plaintiff in that case.  Sullivan, OAJC, 2023 WL 8859656, at *9 (concluding that “proof of business requirements is inadmissible beneath the risk-utility take a look at in strict merchandise legal responsibility circumstances”); at *10 (“compliance with business or authorities requirements shouldn’t be admissible in design defect circumstances to point out a product shouldn’t be faulty beneath the risk-utility concept”).  There stays a viable argument, post-Tincher, that requirements compliance proof could also be admissible as to the opposite prong of Tincher’s “composite” design defect evaluation, the patron expectation take a look at.  See Tincher, 104 A.3d at 402-03.

The buyer expectation argument was articulated within the earlier case, Property of Hicks v. Dana Cos., 984 A.2nd 943 (Pa. Tremendous. 2009) (en banc), determined earlier than Tincher adopted shopper expectations as a Pennsylvania design defect take a look at.  As to shopper expectations, the en banc Hicks resolution acknowledged that “proof of broad use in an business could also be related to show a defect as a result of the proof is probative, whereas not conclusive, on the problem of what the patron can fairly anticipate.”  Id. at 966.  Whereas the chance/utility defect take a look at predominates in Pennsylvania product legal responsibility litigation after Tincher, the Hicks argument stays accessible, ought to a plaintiff assert the patron expectation prong.

Seventh, and eventually, defendants searching for admissibility of FDA compliance proof post-Sullivan ought to research the Donohue Concurrence rigorously and increase the contents of their professional reviews accordingly.  The Concurrence factors out that the defendant’s professional’s report

[T]he vary of things {that a} jury could be instructed to contemplate have been well-known – the Wade Elements, the Barker Elements, and the . . . Pennsylvania Urged Commonplace Jury Directions.  [Defendants] didn’t try to determine the relevance of the relevant business requirements to any of the components beforehand recognized as related to the jury’s willpower {that a} product is unreasonably harmful.

Sullivan, Donohue Concurrence, 2023 WL 8859656, at *13 (footnotes omitted).  The Donohue Concurrence means that that requirements compliance proof could possibly be admissible if the proponent (or the proponent’s professional):  (1) confirmed that the usual or regulation at subject is related to a number of of the components juries contemplate in “figuring out whether or not the product at subject was unreasonably harmful”; (2) positioned the textual content of the usual or regulation in proof; (3) established that the method by which the usual or regulation was created was unbiased; and (4) demonstrated that the aim of the usual or regulation was security associated.  Id. at *13-16.

To keep away from comparable evidentiary issues with respect to FDA proof, protection counsel ought to – significantly in circumstances in state court docket − have their consultants deal with the relevance of FDA-related proof to particular Wade and/or Barker components of their reviews, in addition to the regulatory historical past of the FDA’s motion.  Defendants ought to make detailed provides of proof in response to the opposite facet’s anticipated in limine motions.  Defendants ought to anticipate opposed choices the trial court docket stage, as a result of Sullivan I, and thus Lewis, stay controlling precedent.  Appellate preservation may also be vital.  See Schmidt v. Boardman Co., 11 A.3d 924, 942 (Pa. 2011) (requiring preservation of even “futile” arguments at every judicial stage).

A minimum of in the meanwhile, Mallory ensures that Pennsylvania regulation and process will have an effect on an outsized portion of prescription medical product legal responsibility litigation.  The Sullivan litigation, and the per se exclusionary rule in opposition to requirements compliance proof in Sullivan I, thus have to be on the radar of protection counsel in each prescription drug and prescription medical machine circumstances.  Preservation of the 75-year-old line of Pennsylvania precedent that rejects strict legal responsibility in circumstances involving prescription medical merchandise ought to be protection counsel’s “job one” in such litigation.