Friday, November 28, 2014

Nothing Helps With Post-Thanksgiving Indigestion Quite Like A Heaping Helping Of Express Preemption

            OK, we made that up.  It is not true at all.  A complete lie, much like “The Dallas Cowboys are America’s Team.”  Or “Eating turkey makes you sleepy because of its high tryptophan content.”  Or “The pilgrims left England because of their desire to wear stylish hats.”  Or “Lawyer advertising for drug and device cases serves an important role in improving medical care.”  If you did your duty as an American yesterday and gorged yourself on an assortment of turkey, stuffing, tubers, cranberry compotes, pie, and football, then you may be feeling somewhat bloated today.  You have many options to address that feeling, including taking a walk outside before returning to leftovers and more football.  Reading this post about a recent express preemption decision will not help with indigestion, but it should not hurt either.

            The opinion in Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 U.S. Dist. LEXIS 156563 (D.S.C. Nov. 4, 2014), carved up the product liability claims asserted in connection with a Class III device, specifically a cardiac defibrillator.  As our readers know, the Medical Device Amendments of 1976 served up express preemption for Class III devices—basically, those approved though a Pre-Market Application—as to state law requirements that are “different from, or in addition to” the FDA requirements.  21 U.S.C. §360k(a).  This has been interpreted by the Supreme Court to bar product liability actions premised on claims that do not impose “parallel” duties on manufacturers.  Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); our numerous posts on the subject.    A parallel claim is a “narrow exception to the rule of preemption” into which some courts strain to stuff plaintiff’s claims.  We sometime post on how it grinds us that courts, particularly federal courts sitting in diversity, extend existing state law to allow a claim that would be predicted on non-compliance with an FDA requirement such that imposing liability would not add to the federal requirements on the manufacturer.  Like here.  We do not have that situation in Hesik, which (drum)sticks with South Carolina law as is.  We do have a few twists on the typical arguments we see in cases like this, including that plaintiff had the giblets to move for summary judgment himself.
            The plaintiff in Hesik suffered heart block and atrial fibrillation when defendant’s defibrillator allegedly failed within a year of its implantation to replace another, fried defibrillator.  Defendant evaluated the defibrillator and found areas of blood, areas that were deformed and bubbly, and areas of heat damage—descriptions of many turkeys yesterday that are less desirable for defibrillators.  Accordingly, the defendant dished out a $25,000 credit to the explanting hospital under its five-year vintage warranty and $2500 to the plaintiff under its Unreimbursed Medical Expense Program.  Around the same time, the defendant issued a notice that some of its defibrillator models could fail because of a weakened bond between the header and case, which we assume is somewhere near the wishbone.  Plaintiff mixed these facts with a sprinkling of citations to regulations and unrelated late-reported manufacturing changes and cooked up both an alleged irrefutable admission of product defect and parallel claims.  Although such allegations might let the plaintiff squeeze past a motion to dismiss—as we assume Hesik did here—on summary judgment, the plaintiff needs some proof with his pudding.  (As we know from The Wall, er, something about eating meat before pudding.  They were speaking British and we are still on heels of an American holiday, so the details are unimportant.)  The court sliced, diced, and chiffonaded—seriously, if you not chiffonading your leafy herbs, you are an amateur—the proof proffered for each cause of action and found three of four preempted.

            Negligent design and manufacturing and strict liability were trussed up and cooked in the same pot.  Agreeing with Bass v. Stryker Corp., 669 F.3d 501, 515 (5th Cir. 2012), discussed here, that parallel claims could be premised on the failure of the device to conform to the PMA’s specifications, the court had to look at the evidence of non-conformance—something Bass did not do in the motion to dismiss context.  A granular-level look was not a must, because “Plaintiff has failed to offer any evidence that creates a genuine issue of material fact as to how the Defibrillator deviated from the PMA’s specifications.”  2014 U.S. Dist. LEXIS 156563, *20.  Implicit in the analysis—embreaded, if you will—was that proof of device failure does not equate to proof of nonconformance with the design and manufacturing specifications for the product made a requirement by PMA approval.  Without the right evidence, plaintiff’s negligence and strict liability claims were toast.
            Implied warranty claims often travel hand in oven mitt with design defect claims, such that some jurisdictions do not permit both in the same case.  In South Carolina, implied warranty claims require proof that the product, as designed, was unreasonably dangerous to the user; finding the difference between this version of implied warranty and design defect claim is like distinguishing between a sweet potato and a yam after you mash them up and cook with brown sugar, cinnamon, butter, and perhaps a marshmallow or twenty.  Here, plaintiff pressed that the implied warranty was breached because the product failed within a year.  This was easily seen as an attempt to lard an additional requirement on the manufacturer of the defibrillator beyond what was already imposed by FDA.

            Plaintiff also tried to pour past preemption by asserting claims predicated on violations of federal regulations.  We would have liked to see an appetizer of whether South Carolina had such a claim before the entrée of whether plaintiff had mustard the right proof.  The regulations the plaintiff had cited—defining implantable pacemakers as Class III devices and stating that express preemption does not apply to “requirements of general applicability . . . such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)”—could not be tied to plaintiff’s device and its alleged failure, so the analysis was cut short.  “[W]here a plaintiff relies on nothing more than unsupported violations of general regulations in support of a parallel cause of action, preemption bars the claim.”  Id. at *27 (citations skimmed off by bulb baster).
            The icing on the cake would have been if the last claim had been preempted, but sometimes cake is better without icing.  Here, the express warranty claim—permitted in South Carolina for “any affirmation of fact or promise,” even relayed indirectly to the buyer—was grounded in a voluntary act—the claim that the product would function without failure for five years or certain payments would be made to re-dress any failure.  In the context of express preemption—as opposed to the mélange of implied preemption—voluntariness can mean no preemption.  Nothing about the PMA process or other FDA requirements required the manufacture to sauce its defibrillator with a warranty, let alone the piquant one used here.  Thus, the express warranty claim “presents no risk of interference with the federal medical device regulatory scheme, and the claim escapes express preemption” like some green bean casserole might escape your child’s mouth.  Id. at *25.  And, as with the vegetables left on the plate (or maybe table cloth), after the rest of the meal has been consumed, who are we to be greedy?

* * *
            As you may have surmised, we have not-so-cleverly imbedded a variety of food and drink terms throughout the post.  In case, you need some further distraction before tackling the dishes from last night or whatever else you will be doing this morning, feel free to do our little word search.  If you mark up the post in some efficient way and send your results to Bexis, then he will tally the results (like a scorecard of actual scores for once).  The one who identifies the most will get a mention in a future post, which is almost as good as winning something. 

Wednesday, November 26, 2014

A Thankful Strain

“Our rural ancestors, with little blest,

Patient of labor when the end was rest,

Indulged the day that housed their annual grain,

With feasts, and off'rings, and a thankful strain.”


― Alexander Pope, Imitations of Horace


Today isn't officially a holiday, but the preparations for Thanksgiving make it terribly difficult to put in a productive day at the office.  (Some uncharitable types will wonder how this day is different from any other for this particular scribe.)  Because we will spend at least as much time today picking up organic butter, a bourbon pecan pie, and Beaujolais nouveau as we will perusing babbling briefs, we are thankful.  Tomorrow we will plant ourselves at table, poised between gluttony and gratitude. 


We decided to canvass our DDL blog colleagues on what was making them thankful. Not surprisingly, some mentioned the learned intermediary doctrine, preemption, and statutes of limitations.  There were also shout-outs for Netflix, cornbread sausage dressing, and Eos lip balm.  One particularly high-minded blog editor was thankful to be at a law firm that recognizes the value of thought leadership.  “It takes a lot of non-billable time to write this blog.  A lot!  But it is important to our clients and to the patients who need their medicines and devices, and it is important to us.”  Just so. 


Naturally, Bexis had the most to say.  We will quote his list of thanks: 


·         I’m thankful to DARPA for the internet, without which none of what we’ve done would be possible.  There are some things that the government can do right.


·         I’m thankful to the tobacco companies for carrying the laboring oar in creating preemption in product liability cases.  Cipollone was the first time the United States Supreme Court found preemption in product liability litigation.


·         I’m thankful for Alfred Caronia standing up to the FDA when nobody else would.


·         I’m thankful for Obamacare because everyone deserves access to life-saving drugs and medical devices, and while I personally would prefer a single-payer system, it was the best we could hope for under the circumstances.


·         I’m thankful for off-label use because without it my daughter might have been crippled by juvenile dermatomyocitis, for which there was no on-label treatment.


The author of today’s post also has a list: 


·         Thanks to the Pennsylvania Supreme Court for the Tincher opinion.  Even if Tincher does not quite render our Commonwealth’s product liability law pellucid, it at least strains out the Azzarello murkiness and muck. 


·         Thanks for the Serial podcast, which has created a whole new cultural conversation.


·         Thanks to the Drug and Device Law Daughter for winding up her semester abroad in India without incident.  (Well, almost.  She was hit by a car, but apparently it was a very small, slow car.)  From her Facebook posts, it is clear that she has had quite an adventure in that marvelous country.  It is also clear that she disobeyed our strict instruction not to play with the wild monkeys.  Never mind.  Come home.  All is forgiven. 


·         Thanks to the Drug and Device Law Son for displaying the number one determinant for success in this world: a motor.  His capacity for hard work is especially stunning when we contemplate how our own college days were filled with indolence and things that cannot be discussed in a PG-rated blog.


·         Thanks to our fellow DDL bloggers for basically writing most of today’s post for us.  (Our indolence continues.) 


·         Last but not least, thanks to our clients and colleagues who offer support and suggestions.  We are even thankful for our critics.  If you stop by our house tomorrow, perhaps whilst the Eagles are midway through thumping the Cowboys, we will gladly cut you a slice of bourbon pecan pie.   



Tuesday, November 25, 2014

Thanks for Nothing California

This post is from the non-Reed Smith side of the blog.

            This is the official week in the United States for giving thanks.  Counting your blessings.  Welcoming family and friends to your home.  Christmas might get top billing, but Thanksgiving is all about feeling warm and fuzzy.  And here at the Drug and Device Law Blog, we’ll get to what we are thankful for tomorrow.  Today is a different story.  Today we feel more cold and hard.  And who is the unfortunate recipient of our negativity at this otherwise festive and lighthearted time – California. 

            And why is that we don’t want to share our turkey and pumpkin pie with California?  Three reasons:  negligence, Good Samaritan, and subsequent remedial measures. 

            Plaintiff Christine Scott sued manufacturer C.R. Bard, Inc. alleging injuries resulting from implantation of that company’s pelvic mesh device.  The case went to trial and the jury found the manufacturer negligent and awarded damages (reduced based on finding that surgeon was 40% at fault).  Scott v. C.R. Bard, Inc., 2014 Cal. App. LEXIS 1049, at *1 (Cal. App. Ct. Nov. 19, 2014).  On appeal, the defendant argued, among other things, that the trial court erroneously submitted the negligence theories of liability to the jury, including negligent training and erroneously admitted evidence of post-surgery events.  Id. at *1-2.  The court denied the appeal in its entirety.  We are blogging about this case because it demonstrates the potholes created by California’s recognition of negligence claims in pharma and medical device cases.

            When California rejected strict liability for pharmaceuticals and then medical devices, it did so on the ground that public policy favored bringing new beneficial drugs/devices to market even though they were accompanied by risks.  Therefore, a medical device manufacturer cannot be held strictly liable if its device was properly prepared and accompanied by an appropriate warning. Id. at *13 (citing Brown v Superior Court, 751 P.2d 470 (Cal. 1988)).  Our reading of this is that a medical device manufacturer can still be liable for a manufacturing defect claim and/or for a failure to warn claim.  Bard argued that interpretation to the court – they disagreed.    This is the quote from a footnote in Brown that the Scott court chose to focus on instead:

[Drug and device manufacturers] are subject to liability for manufacturing defects, as well as under general principles of negligence, and for failure to warn of known or reasonably knowable side effects.

Scott, at *15.  And therein lies the foundation for negligent design claims in California.  Seems pretty thin when pitted against the justification for removing strict liability from drug and device litigation, but it’s been enough for some California courts, like this one.

            Next, plaintiff got creative.  Without strict liability, and having apparently been unable to maintain either a manufacturing defect or a failure to warn claim (directed verdict on the former, defense verdict on the latter, id. at *9-10), plaintiff asserted a negligent training claim.  As many device manufacturers do, Bard offered educational opportunities to surgeons.  Specifically, surgeons could attend classes, labs or surgery observations related to its pelvic mesh device.  Id. at *5.  Plaintiff Scott’s surgeon attended one of these sessions, after which her overall impression of the product was that it was safe and superior to other products.  Id.

            Using this as the hook, plaintiff’s negligent training claim is what is often referred to as “Good Samaritan” liability or “negligent undertaking” liability.  We don’t think highly of it no matter what you call it.  This concept holds that a person who undertakes to render services necessary to protect another is subject to liability resulting from a failure to exercise reasonable care.  First, if manufacturers are going to be exposed to liability for offering training, what’s the alternative?  No training.  Why risk offering training, if the result is that it will be held against you.  Second, California courts have further defined the “undertaking” part of the theory as “to render services to another that the defendant should recognize as necessary for the protection of third persons.”   Id. at *17 (emphasis added).  It is extremely difficult to comprehend that a one-day class on a medical device is necessary to protect a surgeon’s patients.  Medical school, internships, residencies, fellowships – those are necessary.  And third, isn’t the court essentially using training to get around the learned intermediary doctrine.  They seem to be saying that by attending this class, the surgeon’s independent medical judgment (all those years of necessary medical training) goes out the window.  Shouldn’t this really just be part of the failure to warn claim?  What information was provided to the surgeon? What information did she independently possess?  Was she adequately warned?  That last question was answered in the affirmative by the jury – a decision that should have swept away the negligent training claim as well.

            Finally, the appellate court upheld the trial court’s decision to admit evidence of subsequent remedial measures (post-surgery FDA regulatory actions).  For various reasons, chiefly not to deter defendants from making things safer, the prevailing rule is that subsequent remedial measures aren't admissible to prove that the defendant was negligent before, for not having done what it later did.  That’s California’s rule too.  Id. at *28-29.  The post-1997 version of Fed. R. Evid. 407 (the relevant federal rule) explicitly states that post-accident changes to a product are not evidence that an earlier version of the product was defective.  In other words, the federal rule was amended to make it clear that the exclusion of subsequent remedial measures applies to strict liability cases as well.  That’s not the rule in California.  According to California, “[w]hen the context is transformed from a typical negligence setting to modern products liability, the public policy assumptions justifying this evidentiary rule are no longer valid.”  Id. at *29. So, California is practically the only jurisdiction that still allows admission of subsequent remedial measures because “strict liability” is different than “negligence.”  That rule is simply nonsensical as we’ve previously discussed here.   

            But wasn’t this a negligence case?  Well, the court got around that by arguing that the post-surgery actions were actually taken by the FDA, a third-party, and that therefore the policy reasons for exclusion didn’t apply in this case.  Id. at *29-30.  We’ve got posts on that too (here and here) – identifying dozens of cases excluding FDA-mandated label changes and recalls.  The fact that the subsequent measure was directed by the FDA doesn’t justify admitting it as evidence.

            We want to stop feeling stern and critical now, and slide into the holiday spirit.  So, as a prelude to tomorrow’s post and on a personal note, the thing this blogger is most thankful for today is a husband who is willing to brave the supermarket -- 2 days before Thanksgiving and on the eve of the first predicted snowfall -- for ginger and nutmeg.     

Monday, November 24, 2014

Judge Posner Drops the Other Shoe on Cy Pres

We posted not too long ago about a Seventh Circuit decision by Chief Judge Posner that we thought had favorable implications for reining in the steadily metastasizing concept of “cy pres” in class action litigation.  That opinion, Redman v. RadioShack Corp., 768 F.3d 622 (7th Cir. 2014), projibited any sum that did not “benefit the class” from being included in the calculation of attorneys’ fees in a class action settlement.  Although a cy pres award was not at issue in Redman, the implications (to us at least) seemed obvious.  Funds not paid to class members do not benefit the class.

Judge Posner made that explicit last week in Pearson v. NBTY, Inc., ___ F.3d ___, 2014 WL 6466128 (7th Cir. Nov. 19, 2014).  Indeed, he thought it was “obvious,” just like we did:

The [trial] judge excluded, however, both the cy pres award of $1.13 million in calculating the benefit to the class, for the obvious reason that the recipient of that award was not a member of the class, and the injunction, which he valued at zero, which was proper too.

Id. at *2.  So, in the Seventh Circuit at least, it’s improper to use funds paid to non-class members via cy pres to calculate the fee that class action plaintiff lawyers are allowed to receive under the “common fund” doctrine.

And there’s more.

The cy pres award itself was overturned.  Not only was the relationship of the would-be recipient to the class “hopelessly speculative,” but it was hardly “infeasible” to send that money to the members of the class, to whom it (supposedly) belonged.  Instead of making the 4.72 million class members jump through all sorts of hoops to file a claim, each member could simply have been sent a chunk of that money:

The $1.13 million cy pres award to the [recipient] did not benefit the class, except insofar as armed with this additional money the foundation may contribute to the discovery of new treatments for [the underlying medical problem that the product in question purported to treat] − a hopelessly speculative proposition. . . .  [T]here is no validity to the $1.13 million cy pres award in this case.  A cy pres award is supposed to be limited to money that can’t feasibly be awarded to the intended beneficiaries, here consisting of the class members. . . .  [T]he claims process could have been simplified . . , [and the defendant] could have mailed [] checks to all 4.72 million postcard recipients.

Pearson, 2014 WL 6466128, at *6.  Cy pres can exist “only if it’s infeasible to provide that compensation to the victims − which has not been demonstrated” where numerous class members have been identified.  Id..

Judge Posner’s reasoning in Pearson (1) reduces the incentive to use cy pres in the first place, because such awards can’t inflate attorneys’ fees, and (2) restricts when cy pres can be used to situations where its infeasible even to identify class members.  If class members can be identified, then ipso facto, cy pres isn’t available, since the money can be divided among those members.

Of course, if it is actually infeasible even to identify the persons who are allegedly wronged by a defendant’s conduct, then the action should be dismissed at the outset.

While we would prefer to abolish cy pres altogether as ultra vires  − and are supporting efforts to do just that − Pearson is a big step in the right direction. 

We thank Ted Frank of the Center for Class Action Fairness, who won Pearson, for passing it along to us.

Thursday, November 20, 2014

Pennsylvania Product Liability – Azzarello Is Dead, Long Live…?

Bexis is pretty pleased this morning.  Almost eighteen years ago, to the day, he filed his first brief with the Pennsylvania Supreme Court challenging the negligence/strict liability dichotomy adopted in Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978) (in a case called Spino).  Over twelve years ago, he filed his first outright “overrule Azzarello” brief (in a case called Phillips).  Well, yesterday the Pennsylvania Supreme Court did precisely that – it overruled Azzarello – unanimously in an opinion written by Chief Justice Castille.  In the end, even the most pro-plaintiff members of the Court (those remaining, anyway) could not stomach the travesty that Azzarello had become.  End of self-congratulatory gloat.

We learned of this development late yesterday afternoon and published a very brief “breaking news” post alerting our readership.  At that point we had not yet read the Court’s entire 137-page opinion, Tincher v. Omega Flex, Inc., No. 17 MAP, slip op. (Pa. Nov. 19, 2014).  Now we have.  While it’s clear that the most obnoxious aspects of the Azzarello regime − the bizarre pre-trial procedure for determining “unreasonably dangerous” as a matter of law, the absolutist negligence/strict liability dichotomy, and the “plaintiff wins” guarantor/any element jury instruction (for those of you not familiar with Pennsylvania law, this is what jurors are instructed: “The supplier of a product is the guarantor of its safety.  The product must, therefore, be provided with every element necessary to make it safe for its intended use, and without any condition that makes it unsafe for its intended use,” Azzarello, 391 A.2d at 559 n.12) – have been disapproved, what’s taken their place is less clear.

On the theory that you can’t beat something with nothing, ever since Phillips Bexis had been advocating the Third Restatement of Torts as an alternative, even though there were significant aspects of the Third Restatement that could hardly be called defense friendly.  Yes, Azzarello was that bad.  The Court, however, did not adopt the Third Restatement in Tincher.  Instead, it has adopted a more mainstream (compared to Azzarello) approach to Restatement Second §402A, that in places is also informed by Third Restatement principles.  We’ll be discussing that in more detail.
It could have been better, at least for non-drug device defendants (see the dissenting part of the concurrance/dissent), but compared to Azzarello the result is excellent.

Tincher’s Impact on Drugs and Medical Devices

First, how does Tincher affect drugs and medical devices, the primary focus of this blog?  For prescription products, the short answer is “not much.”  One of the adverse consequences of Azzarello’s negligence/strict liability dichotomy was precedent that rejected state of the art as a “negligence principle.”  Largely as a result of concerns over liability for scientifically undiscovered risks (something the Supreme Court never really had to address), in Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (another case Bexis briefed) the Court excluded prescription medical products entirely from Azzarello strict liability using Restatement §402A, comment k.  See Tincher, slip op. at 59 n.13 (describing Hahn holding as “where adequacy of warnings associated with prescription drugs is at issue, strict liability is not recognized as basis for liability”).  Thus Tincher’s reworking of strict liability doesn’t affect prescription medical products because that theory wasn’t applicable in the first place.  Indeed, one of Bexis’ worries about the Third Restatement was that eventually it might call the Hahn strict liability exemption into question.  Without the Third Restatement, that doesn’t happen.

However, Azzarello strict liability has been imposed on manufacturers of over-the-counter (“OTC”) drugs.  Dunson v. McNeil-PPC, Inc., 2009 WL 1178651, at *4-5 (Pa. Super. April 24, 2009); Wolfe v. McNeil-PPC, Inc., 773 F. Supp. 2d 561, 568 (E.D. Pa. 2011).  Thus, OTC manufacturers will be able to take advantage of the post-Azzarello landscape, even on current appeals, if they’ve properly preserved the issue.

Generic drug manufacturers, however, should note Tincher’s express rejection of absolute liability.  Slip op. at 85.  This closes one (nonexistent) loophole to preemption that the Superior Court had attempted to leave open in the Reglan Trilogy .

Tincher’s Historical Overview

So what do we have?  Fortunately, most of the first half (56 pages) of the Court’s opinion is prefatory and don’t require much discussion.  The Court engages in a long historical review of early Pennsylvania strict liability cases under §402A.  The purpose of this is to underscore how the Court in those cases made a number of overly broad and less-than-thought-out statements in the course of adopting and applying §402A.  E.g., Tincher, slip op. at 44 (Webb v. Zern “offered little explanation of its reasoning for formally adopting the Second Restatement”); 49 n.11 (other “interim” cases decided “without offering any insight into foundational matters of concern”); 50 (several decisions “lapsed, generally, into comparisons with the more familiar negligence and warranty causes of action”).  In discussing the plurality decision in Berkebile v. Brantly Helicopter Corp., 337 A.2d 893 (Pa. 1975), the Tincher court observed that the infamous “every element necessary to make it safe” language arose in a discussion of warning defects.  Slip op. at 55.  Tincher summed up the early §402A cases thusly:

[I]t is now apparent that the first decade of applying the doctrine of strict liability in Pennsylvania offered a series of missed opportunities to develop a vibrant and coherent body of common law on the issue.

Slip op. at 56.  The foundation that these cases laid for strict liability was “confus[ed] and “formulaic”:

To the extent that the Court spoke to broader considerations, several trends became evident:  . . . rhetoric emerged not only to distinguish strict liability from its negligence roots, but also to excise negligence principles and terms (such as foreseeability) from strict liability theory; the reliance upon formulaic reiteration of consumer protection-related policies, offered as a bulwark against attempts to dilute the application of strict liability theory in individual cases; and then a focus in strict liability theory that ultimately turned upon a statutory construction-type of analysis of the Second Restatement.  Experience suggests that these trends, and fits and starts, have proven antithetical to the orderly evolution of our decisional law, one that must be responsive to new problems, perspectives, and consequences.

Id. at 57 (emphasis added).  Ouch.  That’s what one calls repudiation.

Tincher discussed Azzarello.  It pointed out that the “every element” language from Berkebile “was quoted subsequently out of context by the majority in Azzarello as the standard of proof in a strict liability action.”  Slip op. at 56.  It explained the removal of “unreasonably dangerous” from jury consideration and pointed out that court’s reliance on the Cronin case from California.  Id. at 57-58.  “According to the [Azzarello] Court, in cases of an alleged defective design, the dispositive question is whether the product is safe for its intended use.”  Id. at 59.  Azzarello required that the jury be instructed that the manufacturer was a “guarantor” of safety and “should not be instructed on the “unreasonably dangerous” standard.”  Id.

In discussing post-Azzarello cases, Tincher analyzed in detail the majority, concurring and dissenting opinions in Lewis, the holding of which was to exclude evidence of industry standards in strict liability cases as “negligence” related.  Slip op. at 60-62.  It also addressed “doctrinal separation” and the Court having been “adaman[t] that negligence concepts have no place in a strict liability action” expressed in the Kimco case refusing to allow comparative negligence in strict liability cases.  Id. at 62-63 & n.14.

Turning to more recent cases, Tincher focused primarily on their discussions of the Third Restatement of Torts – not surprising, given that this was a question that the Court expressly intended to decide in Tincher.  In Phillips, only one justice was willing to decide the case based on the Azzarello negligence/strict liability dichotomy.  That justice thought the Third Restatement question waived (which in fairness it probably was, as Bexis raised it in an amicus brief).  Tincher, slip op. at 64.  One justice in Phillips did not agree on the negligence analysis.  Three concurring justices in Phillips (including (then) Justice Castille) “advocated taking the opportunity to address foundational matters, to reassess Pennsylvania’s Second Restatement approach, and to examine the range of readily accessible, corrective measures, including adoption of the Third Restatement.”  Slip op. at 65.

In relevant part, the concurrence addressed three points: first, that strict liability doctrine is embedded with concepts central to negligence theory; second, that ambiguities and inconsistencies in prevailing strict liability jurisprudence affected the proper disposition of the appeal; and third, that the Third Restatement’s approach would provide the most viable route to clarification and remediation of strict liability jurisprudence in Pennsylvania.

Id. (describing Phillips concurrence).  Tincher goes on to describe the Phillips concurrence at length, in part because of the Tincher defendant’s advocacy of the same rationale.  Id. at 65-68.

Tincher also discussed various Third-Restatement-related statements in the decade following the 2003 Philllips opinion.  In particular this discussion included the dissent from dismissal of the Bugosh appeal as improvidently granted, also joined by Chief Justice Castille, that included the following points:  (1) the “categorical divide between strict liability and negligence principles,” is “far more problematic” in design and warning cases; (2) “the alternative of a judicially imposed mandatory insurance scheme . . . is unpalatable and incongruent with the general rejection of a pure loss-spreading tort”; (3) Azzarello “was not reasoned well in its time and has not withstood the test of time”; (4) the legislature was “best positioned” to address product liability but had failed to act; and (5) “the difficulties . . . are with Azzarello rather than the Second Restatement itself.”  Tincher, slip op. at 69-72.  See also Id. at 73-74 & n.16 (discussing Third Circuit’s Berrier prediction of adoption of Third Restatement and several “tangential” recent decisions).

Overruling Azzarello

After all that preface, Tincher overruled Azzarello.  Azzarello articulates governing legal concepts which fail to reflect the realities of strict liability practice and to serve the interests of justice.”  Slip op. at 74.  It got rid of Azzarello’s relegation of the “unreasonably dangerous” prong of §402A to a preliminary question of law to be decided courts rather than juries.  It criticized Azzarello for “approv[ing], and thereby essentially requir[ing], instructions which informed the jury that, for the purposes of a supplier’s strict liability in tort, ‘the product must, therefore, be provided with every element necessary to make it safe for its intended use’.”  Id. at 75.  “Subsequent decisional law has applied Azzarello broadly, to the point of directing that negligence concepts have no place in Pennsylvania strict liability doctrine.”  Id.  These errors, Tincher went on to explain, “led to puzzling trial directives that the bench and bar understandably have had difficulty following in practice, including in the present matter.”  Id.

Thus, Tincher disapproves of three key aspects of prior Pennsylvania strict liability law:  (1) the “each and every element”/”guarantor” jury instruction; (2) taking “unreasonably dangerous” issues away from the jury and giving them to courts; and (3) the strict separation of negligence and strict liability concepts.

These problems arose, first because Azzarello had treated §402A as if it were a statute, which was improper:

The Court [in Azzarello] parsed the language of the Second Restatement, particularly the terms “defective condition” and “unreasonably dangerous,” for a precise meaning and the reporter’s intent in the utilization of those terms.  But, Section 402A does not articulate legal “requirements” as a statute may; and, moreover, the “intent” of the reporter is, of course, not due the same weight as a pronouncement of legislative intent. . . .  Yet, the Azzarello Court seemed to engage in a statutory-type construction of Section 402A, including by proceeding to presume every part of Section 402A effective.

Tincher, slip op. at 76.  Further, the non-Rstatement precedent that Azzarello followed has not stood the test of time.  Azzarello relied upon cases from California (Cronin) and New Jersey (Glass) that have both been overruled in those states.  Tincher, slip op. at 78.  “Pennsylvania, unfortunately, did not adjust its jurisprudence in light of these developments that eroded Azzarello’s underpinnings.”  Id.

Jury Instruction:  Nor were the “generalities” in Azzarello “that negligence-related rhetoric saddles a plaintiff in a strict liability case with an additional and unwarranted burden of proof” necessary.  Id. at 76-77.

The facts of Azzarello, when viewed with the appropriate judicial modesty, did not require such a broad pronouncement. . . .  The Azzarello Court offered no explanation of either the nature of the perceived unwarranted additional burden nor how that burden altered the liability calculus

Id. at 77.

Azzarello’s imposition of a lock-step strict liability jury instruction omitting reasonableness and foreseeability was excessive and unwise:

Nor did the Azzarello Court explain the leap in logic necessary to extrapolate that every lay jury would relate reasonableness and other negligence terminology, when offered in a strict liability charge, to a “heavier,” negligence-based burden of proof.  Jury charges are generally delivered orally to ordinary citizens, and not by written transmission to be pored over by scholars or lawyers. . . .  The concern with across-the-board jury confusion, especially where counsel is there to suggest adaptation of standard charges and to hear the charge as a whole, is simply overstated.

Tincher, slip op.. at 77.  The Azzarello jury instruction “essentially perpetuated jury confusion in future strict liability cases, rather than dissipating it.  Id.  Azzarello and its progeny “compounded the problem . . . by . . . ‘approving’ jury instructions in strict liability cases generally.”  Id. at 79-80.

Predictably, the “approval” of such jury instructions operated to discourage the exercise of judicial discretion in charging the jury, including in the Tinchers’ case, and likely stunted the development of the common law in this area from proceeding in a more logical, experience-based and reason-bound fashion.

Id. at 81.  The Azzarello jury instruction was also “impractical.”  Id.  “[T]he Azzarello Court offered that a supplier is not an insurer of a product, although it is a guarantor; these [being] terms of art, with no further explanation of their practical import.”  Id.

The Tincher Court does not offer a replacement strict liability charge.  Instead it refers to “the fashioning of suggested jury charges applicable to a particular case.”  Id. at 128.

[I]t is incumbent upon the parties, through their attorneys, to aid courts in narrowing issues and formulating appropriate instructions to guide juries in their factual determinations.  It is worth reiterating that bright lines and broad rules always offer a superficially enticing option . . . judicial modesty counsels that we be content to permit the common law to develop incrementally.

Id. at 128-29 (citation and quotation marks omitted).  Thus, in this particular instance the Court did replace something with nothing.  As for jury instsructions, the Azzarello instruction is error, and it will be like the Wild West out there, at least for a while.  Instead of Azzarello, jury instructions must be tailored to the specific facts and theories in a given strict liability case:

In charging the jury, the trial court’s objective is to explain to the jury how it should approach its task and the factors it should consider in reaching its verdict.  Where evidence supports a party-requested instruction on a theory or defense, a charge on the theory or defense is warranted.  At that point, the trial court has broad discretion in phrasing its instructions, and may choose its own wording so long as the law is clearly, adequately, and accurately presented to the jury for its consideration.  It is essential for the bench and bar to recognize that the test we articulate today is not intended as a rigid formula to be offered to the jury in all situations.

Slip op. at 130-31.  “The crucial role of the trial court is to prepare a jury charge that explicates the meaning of “defective condition” within the boundaries of the law . . . and the facts that pertain.”  Id. at 132-33.  There is no single, mandatory instruction anymore.

Unreasonably Dangerous:  Taking risk-utility balancing away from the jury and giving it to “judges” because the “unreasonably dangerous” element of §402A sounded in negligence was also “problematic on its face.”  Id. at 82.  Keeping risk-utility separate from the “condition of the product” “is incompatible with basic principles of strict liability.”  Id.  It also places courts in an untenable position:

[T]rial courts simply do not necessarily have the expertise to conduct the social policy inquiry into the risks and utilities of a plethora of products and to decide, as a matter of law, whether a product is unreasonably dangerous except perhaps in the most obvious of cases.

Id. at 81-82 (using a knife being sharp as example).  This, too, is “impractical” and “would encourage trial courts to make either uninformed or unfounded decisions of social policy.”  Id.

Going forward, “severing findings relating to the risk-utility calculus from findings related to the condition of the product is impracticable and inconsistent with the theory of strict liability.”  Slip op. at 129.  Instead of a special procedure – with plaintiffs excused from ever meeting their burden of proof – the jury explicitly considers risk-utility, and “whether the party has met its burden of proof” is decided under the normal standard otherwise applicable to jury questions.  Id. at 132.

Negligence versus Strict Liability:  The notion of an absolute dichotomy between negligence and strict liability was also “confusing” and ultimately not “viable”:

Subsequent application of Azzarello elevated the notion that negligence concepts create confusion in strict liability cases to a doctrinal imperative, whose merits were not examined to determine whether such a bright-line rule was consistent with reason in light of the considerations pertaining to the case.  Beyond the merits of the narrow holdings in the several cases, the effect of the per se rule that negligence rhetoric and concepts were to be eliminated from strict liability law was to validate the suggestion that the cause of action, so shaped, was not viable, and to invite calls for reform.

Id. at 83-84 (citations omitted).

The dichotomy between strict liability and negligence often arose in evidentiary matters.  Tincher does not directly address particular evidentiary exclusions, none of which was before the Court, id. at 127, but holds generally that neither side’s interests are superior.  Thus “evidentiary considerations . . . should not be mistaken for the question of whether a substantive duty in strict liability exists or should exist, or what constitutes a breach.”  Id. at 89.  “As with any other tort relationship, the supplier and the consumer are protecting legitimate but conflicting interests.”  Id. at 91.  On the consumer’s side, are “interests in the safe continued use of a product and, relatedly, in the cost of any injury,” counterbalanced by “economic, moral, and visceral interests in the sales price of the product, the availability of new or innovative products, and in any spillover effects.”  Id.  On the supplier’s side are “generat[ing] a sustained profit” along with “maintaining a reputable name and in providing new or innovative products,” counterbalanced by “a moral interest in providing a safe product with minimal negative externalities.”  Id.  It is this “balance of interests respecting what is socially or economically desirable” that should determine what is relevant evidence.”  Id. at 92.

Lewis and its state-of-the-art progeny had precluded such “negligence evidence in all strict liability actions.  Tincher recognizes that result as excessive:

Derived from its negligence-warranty dichotomy, the strict liability cause of action theoretically permits compensation where harm results from risks that are known or foreseeable (although proof of either may be unavailable) − a circumstance similar to cases in which traditional negligence theory is implicated − and also where harm results from risks unknowable at the time of manufacture or sale − a circumstance similar to cases in which traditional implied warranty theory is implicated.  The difficulty is in cabining liability premised upon a risk unknowable at the time of manufacture/sale, which was logically unavoidable, in circumstances in which liability and attendant compensation was potentially limitless.

Slip op. at 126-27 (emphasis added).  Tincher did not involve the latter (unknowable risk) situation.  Rather, their claim “claim was essentially . . . that the risk of harm related to [the product] was both foreseeable and avoidable.”  Id. at 127.  Such “typical” allegations “bear the the indicia of negligence.”  Id.  They are situations in which the Third Restatement’s alternative design requirements make sense.  Id.  But not all cases are “typical.”  Id. at 128.  What evidence is admissible in strict liability for now will be decided on an “incremental” basis.  Id. at 129.

What Replaces Azzarello?

It appears that the Tincher court viewed Azzarello’s chief vice as lack of judicial “modesty.”  “This case speaks volumes to the necessity of reading legal rules – especially broad rules -- against their facts and the corollary that judicial pronouncements should employ due modesty.”  Id. at 79.  Trying to “extrapolate broad lessons” from Azzarello, its progeny tied the law in knots:

As courts have struggled with the application of the deceptively simple Azzarello rule that a jury must be insulated from negligence concepts and rhetoric in strict liability cases, decisional law has lapsed into an arguably unprincipled formulaic application of rhetoric, threatening to render the strict liability cause of action hopelessly unmoored in modern circumstances.

Id.  To replace Azzarello, the Court first implored the Legislature to enact “comprehensive legislative reform” that “address[ed] this arena of substantive law.”  Id. at 84.  But recognizing that legislative action “remains unlikely or uncertain,” the Court had to do something, particularly since it realized that “the underlying problem derives from our own decisional law.”  Id.  See also id. at 111 (“special tort-insulated status for certain suppliers . . . requires an assessment and balancing of policies best left to the General Assembly”) (citation and quotation marks omitted).

Third Restatement Relevant but Not Adopted:  This “modesty” and distaste for what transpired in the wake of Azzarello more than anything explains the Tincher court’s reluctance to exchange their demonstrably failed body of broad product liability principles for another body of broad product liability principles represented by the Third Restatement.  As for former, “what drives the [ALI] and treatise writers does not make comparative modesty, nuance, and reticence in the judiciary mistaken (much less make indecisive) in a jurisdiction, like Pennsylvania, where the area, to date, has been the exclusive province of the common law.”  Tincher, slip op. at 111-12.  As for the latter:

[O]ur reticence respecting broad approval of the Third Restatement is separately explainable by looking no further than to the aftermath of Azzarello, whose negligence rhetoric-related doctrinal proscription arising from a peculiar set of circumstances had long-term deleterious effects on the development of strict liability law in Pennsylvania.

Id. at 116.  This is rather ironic, since the Second Restatement, which Tincher kept, was adopted in a far more precipitous manner (which the Court admitted) than the consideration given to the Third Restatement.

The Court seemed comfortable with many of the principles in the Third Restatement – save its universal alternative design requirement, which it viewed as “problematic” because it “articulat[ed] the burden of proof in terms of evidence (alternative design).”  Slip op. at 108-09.  The court was not impressed with using evidence in that fashion.  Nor did the Court wish to create “a priori categorical exemptions for some products.”  Id. at 109.  It counted itself among those that “cannot foresee all the myriad products and circumstances that may arise.”  Id. at 110.  The majority (because at this point the concurrence becomes a dissent) views “public policy” as being “that compensation is available for an injury caused by any type of defective product”) (emphasis original).  Instead it “settle[d] for the incremental approach.”  Id. at 116.

Otherwise the majority – as well as the dissent – was receptive to the Third Restatement’s view of alternative design as “highly probative” of the existence of defect in the “typical” design defect case:

That evidence of the existence and specifications of an alternative design is relevant and even highly probative to prove disputed issues in a products liability case, such as technological feasibility, cost, etc., is certainly true.  That the more typical case implicates the type of products and circumstances in which evidence of an alternative product design is the most persuasive and efficient means of convincing the trier of fact may also be true.

Tincher, slip op. at 113.  The Court simply was not willing to risk “wooden application of
abstract principles to circumstances in which different considerations may pertain.”  Id. at 114 (citation and quotation marks omitted).  The Court recognized that in a “typical” case – involving “foreseeable” and “avoidable” risks – many of the Third Restatement’s “insights” about alternative designs would be pertinent:

[I]n some respects this is the “typical” case, which explains both the insight that in design cases, the character of the product and the conduct of the manufacturer are largely inseparable, and the Third Restatement’s approach of requiring an alternative design as part of the standard of proof.

Id. at 127.  The problem with wholesale adoption of the Third Restatement “is that courts do not try the ‘typical’ products case exclusively and a principle of the common law must permit just application to myriad factual circumstances.”  Id. at 128.

Renovating §402A:  In deciding with what to replace Azzarello, if not the Third Restatement, Tincher quickly rejected “absolute” liability.  Slip op. at 85 (“experience has taught otherwise and, in modern application, strict liability doctrine is a substantially narrower theory”).  It decided to stick with a “properly calibrated” version of Restatement Second §402A.  The Court sought guidance from classic negligence concepts – duty and breach.  “The duty in strict liability pertains to the duty of a manufacturer and of suppliers in the chain of distribution to the ultimate consumer.”  Id. at 87-88 (referencing Restatement §402A, comment c).  Strict liability exists so that:

a person or entity engaged in the business of selling a product has a duty to make and/or market the product -- which “is expected to and does reach the user or consumer without substantial change in the condition in which it is sold” − free from “a defective condition unreasonably dangerous to the consumer or [the consumer’s] property.”

Id. at 88 (quoting Restatement §402A(1)).  Breach of the duty requires proof of a “defective condition,” which is a “legal term of art” suggesting “neither its colloquial import nor a scientifically immutable fact.”  Id. at 89.

Composite Standard:  After thoroughly discussing each alternative, Tincher adopted a “composite” standard including both “consumer expectation” and “risk utility” definitions of defect, recognizing drawbacks to each.

[I]n Pennsylvania, the cause of action in strict products liability requires proof, in the alternative, either of the ordinary consumer’s expectations or of the risk-utility of a product To maintain the integrity and fairness of the strict products liability cause of action, each part of this standard of proof remains subject to its theoretical limitations.

Slip op. at 119.  This test allows the plaintiff, initially to choose the theory as “master” of his/her claim.  Id. at 130.  The defendant can always challenge the plaintiff’s choice of theories, based on the drawbacks (see below) of that theory:

A defendant may also seek to have dismissed any overreaching by the plaintiff via appropriate motion and objection.  The trial court is to act in its ordinary gate-keeper role . . . adjudicating . . . pending objections and motions, including those seeking to narrow, or expand, the theories of litigation to be pursued at trial.

Id. (citing Soule, a California case holding reliance on consumer expectations to be improper).

The Tincher court understood that a composite test invites a distinction between simple and complex products that could potentially cause the same problems as Azzarello if factual distinctions are “mistaken for establishment of a distinct burden of proof, and treated as doctrine.”  Slip op. at 103-05 (discussing Barker and Soule cases from California).  The Tincher court viewed the Third Restatement as another variant of the “combined” approach, folding consumer expectation principles into an overall risk/utility approach.  Id. at 104 (“a variation upon those tests primarily based upon a risk-utility determination by requiring proof of a reasonable alternative design”).

Consumer expectation:  The consumer expectation standard is that “the product is in a defective condition if the danger is unknowable and unacceptable to the average or ordinary consumer.”  Slip op. at 95.  “The nature of the product, the identity of the user, the product’s intended use and intended user, and any express or implied representations by a manufacturer or other seller are among considerations.”  Id. (citing, among other things, Restatement §402A, comment i).  Limitations of the consumer expectation test are:  (1) “obvious dangers” exempt products from liability; and (2) the test becomes “arbitrary” if applied to “complex” products “whose danger is vague or outside the ordinary consumer’s contemplation.”  Id. at 97-98.

Risk/Utility:  The “risk/utility” standard is” a test balancing risks and utilities or, stated in economic terms, a cost-benefit analysis.”  Tincher, slip op. at 98.  “The risk-utility test offers courts an opportunity to analyze post hoc whether a manufacturer’s conduct in manufacturing or designing a product was reasonable, which obviously reflects the negligence roots of strict liability.”  Id. at 99.  Limitations of the risk/utility test are:  (1) “not be[ing] immediately responsive in the (typical) case implicating allegations relating to a particular design feature”; and (2) “in some respects, it conflicts with bedrock moral intuitions regarding justice in determining proper compensation.”  Id. at 99-100.

Choice of Theories:  In choosing between the two in any given case, the Court recognized that “the theory of strict liability as it evolved overlaps in effect with the theories of negligence and breach of warranty.”  Slip op. at 121.  It “combin[es] the balancing of interests inherent in those two causes of action.”  Id.  Reflecting this “duality of purpose,” a composite formulation of strict liability “articulate[s] a standard of proof which stated the consumer expectations test and the risk-utility test in the alternative.”  Id. at 122.  The Court further viewed this duality as springing from the abolition of privity – while the manufacturer “engages in a risk-utility calculus,” intermediate sellers “implicitly represent[]” the non-defectiveness of the product as in a warranty claim.  Id. at 123.

Miscellaneous Stuff

The Court speculates that it’s possible there could be situations that would justify reversing the burden of proof.  Tincher, slip op. at 133-35.  This is primarily another bad idea out of California.  The Court ultimately didn’t decide anything, or change the usual civil burden of proof, but it’s something else that’s now out there.  Bexis’ work is never done.

The court mentioned that the law could change about other things – “foundational issues regarding manufacturing or warning claims” and “subsidiary” issues “such as the availability of negligence-derived defenses, bystander compensation, or the proper application of the intended use doctrine.”  Id. at 135.  Again, issue-spotting; nothing more.

Having not adopted the Third Restatement, the Court declined to make any special holding about the retroactivity of its decision.  Id. at 136.  Having “preserved the issue and presented its claim that Azzarello should be overruled” the defendant “is entitled to the benefit of [the] decision.”  Id.  Thus, there’s nothing in Tincher to prevent the usual retroactive application of an appellate decision.

“[T]he general rule is that all decisions are to be applied retroactively.”  Commonwealth v. Gray, 503 A.2d 921, 926 (Pa. 1985).

[T]he general law of our Commonwealth continues to be, as it was at common law, that our decisions announcing changes in the law are applied retroactively, until and unless a court decides to limit the effect of the change, and that litigants have a right to rely on the change, especially if they have a suit pending in our courts at the time the change is announced.

McHugh v. Litvin, Blumberg, Matusow & Young, 574 A.2d 1040, 1044 (Pa. 1990).

Bottom line?  Azzarello was so bad for defendants that practically anything is an improvement.  Tincher gets rid or three really pro-plaintiff things:  the “plaintiff wins” Azzarello jury instruction, the negligence/strict liability dichotomy which is the basis for several awful evidentiary exclusions, and the jury not being to decide risk utility with the plaintiff bearing the  burden of proof.  We don’t particularly like the consumer expectations test, as it has been prone to abuses in other jurisdictions, however, Tincher explicitly recognizes that theory’s problems and authorizes defendants to challenge its use in inappropriate cases.  Nothing in Tincher undermines the application of Restatement §402A, comment k in Hahn.  All in all, defendants are significantly better off today than they were yesterday.