Wednesday, March 04, 2015

An Error-free Seventh Circuit Medical Device Case

Today is National Grammar Day. Before anyone of our posts goes online, it dashes thorough a gauntlet of reviewers.  Those reviewers collectively possess just the right amount of neurotic fastidiousness to ensure that what emerges is mostly correct and at least intermittently coherent.  Some of us pretend to actually know Strunk & White by heart.  Still, errors occasionally evade the dragnet of dorks. In honor of National Grammar Day, we have festooned today's post with enough errors to keep all of you grammar cops busy.  We do this as a matter of principal. 


But there are no errors in the case under review.  We have a rare favorable medical device decision out of the Seventh Circuit. The case is called Kallal v. Ciba Vision Corporation Inc., 2015 U.S. App. LEXIS 2987 (7th Cir. Feb. 24, 2015).  Mind you, the Seventh Circuit is one court we think the world of. Any court that is home to legal luminaries like Posner, Easterbrook, Wood, et al. must be fairy formidable.  But the Seventh Circuit is also home to the hideous Bausch precedent.  Perhaps you remember Bausch.  Its hard to forget.  The Seventh Circuit permitted a plaintiff to vaguely state a parallel claim which lacked substance under both federal and state law.  TwIqbal pleading requirements impacted the case not at all.  Irregardless of the Supreme Court's instruction that lame cases should be dismissed before subjecting defendants' to expensive discovery, the Bausch court elevated the plaintiff's desire for discovery into something sacramental. 


But Kallal is much better than that is. The plaintiff claimed that defective contact lenses had hurt his eyes.  The plaintiff did not have alot of evidence. The company had recalled some of it’s contact lenses.  Courageously (after Bausch) the district court held that the plaintiff's claims were preempted nonetheless, and that the parallel claim could not save the case.  The plaintiff argued that his suite fit inside of the Riegel exception because the company failed to list ion permeability as a “material characteristic” in its premarket approval list.  The company responded that the FDA did not require them to meet any ion permeability threshold.  The plaintiff did not offer any evidence to the contrary.  In any jurisdiction but Bausch-land, that argument would win the preemption day for the defendant.  And mirabile dictum, it managed to win for the defendant in Kallal.  At least at the lower court’s level. 



The Seventh Circuit upheld the dismissal, but they skirted the parallel claim exception - and not needing to grapple with Bausch's jabberings - by only holding that there was insufficient evidence of usage. The Kallal court called "classic dicta the lower court's preemption analysis, that "can be sloughed off without damaging the analytical structure of the opinion.”  You can often count on such poetry from the Court of Appeals seated in the City of Big Shoulders.  Sweet home Chicago, named after a stinky onion, the cow butcher to the Republic, and shelterer of Carl (and Ryne) Sandburg, Buddy Guy, and all those "Yes-and"-ers at Second City.  "The whole world’s watching."  The place where Republicans, antitrust plaintiffs, and the Cubs lose with startling regularity.  Surely Chicago, along with the City of Botherly Love, is one of the preeminent places to be a litigator - excuse us: trial lawyer.  We like the Kallal opinion almost as much as we like deep dish pizza and Grant Achatz. 




Here is the problem for the plaintiff in Kallal:  the company's records did not show the recall including the lenses used by the plaintiff.  None of the recalled lenses were in the plaintiffs' prescription strength.  Against the company's records showing that plaintiff's lenses were not covered by the recall, the plaintiff mounted 2 responses: (1) the voluntary recall was so huge that the company could not possibly have known which lenses were defective (that is, the company got it wrong); and (2) some of the lenses the plaintiff wore were manufactured in an Indonesian plant that had manufactured also the recalled lenses.  From that, the plaintiff inferred that every lens made in that factory must have been similarly flawed.


The plaintiffs claim resembled res itsa loquitur, but that didn't work because evidence suggested the plaintiff might have had an allergenic reaction.  He had had problems with other companies' contact lenses as well.  Oops.  The district judge dismissed the plaintiff's evidence as a mere “wisp of circumstantial evidence” and the Seventh Circuit agreed.  No design defect theory would establish the defendant's liability as against the plaintiff was simply being allergic to all contacts.  And while its true that the plaintiff exhibited symptoms after wearing the defendant's contact lenses, the record needs to show more than post hoc, ipso propter hoc -- the mere fact that a person suffers pain when using a product does not, by itself, disprove that the product isn’t defective.
In any event, the plaintiff also could not defend a summary judgment motion just by attacking the credibility of the other side’s affirmative evidence that there was no claim. To quote another Latin aphorism - this one adorned the cafeteria door at our Catholic high school - fidem clam scit.


The plaintiff also made an argument that has sadly some basis in Bausch: that the record was incomplete, because the district judge abused her discretion where she denied his request for more discovery.  As an initial procedural hurdle, the plaintiff had failed to life a Rule 56(d) affidavit explaining why he needed additional discovery.  Come to think of it, plaintiff's usually do not file affidavits like that.  Which is nice.  Further, it was clear that further discovery would be futile.


Thus spaketh the Seventh Circuit.  We look upon its result and smile.  But when we look upon the above paragraphs, with its many grotesque mistakes, we do not smile.  In fact, what we wrote makes our eyes hurt.


Tuesday, March 03, 2015

A Pleasant Surprise from the Accutane MCL

A couple of weeks ago, we talked about Westminster Kennel Club Dog Show.  We were eagerly anticipating the Best in Show competition, which was slated to feature a Standard Poodle – the breed of our heart – along with a Portuguese Water Dog whose record of wins was unprecedented in dog show history.  Based on this past record, the “PWD” was heavily favored to “take the Garden.”   The Best in Show judge (few assignments in dogdom carry more prestige) built the tension in the sold-out stadium to a fever pitch.  The dogs submitted to painstaking “hands on” examinations, they “free-stacked,” they gaited.   And they gaited again.  Finally, the judge, flanked by AKC officials, strode purposefully to the table to “sign the book,” then returned to the center of the ring, microphone turned on, purple and gold rosette and trophy in hand.   He made a moving speech about the history of the event, and he praised the lineup of seven gorgeous group winners.   Pausing one more time for effect, he announced, “Best in Show at the 139th Westminster Kennel Club Dog Show is . . .  the Beagle!”  The Beagle?   Make no mistake – “Miss P” is a spectacular show dog, with many Best in Show wins to her credit.  She is a striking example of her breed.  And she is very, very cute.   But it just wasn’t what we expected. 

We also thought we knew what to expect when we began reading the recent decision of the Superior Court of New Jersey – Atlantic County -- in the Accutane Multicounty Litigation.   This litigation, in which plaintiffs allege that Isotretinoin (Accutane’s chemical name) causes Inflammatory Bowel Disease (“IBD”) and Crohn’s Disease (“CD”), has been pending since 2003, and we have been troubled, at times, about an apparent plaintiff bias. Appellate courts have agreed with us, overturning a number of plantiffs' verdicts.  (See here and here, for example.)  But we were most pleasantly surprised this time. 
In In re Accutane Litigation, 2015 WL 753674 (N. J. Super. Law. Feb. 20, 2015), the Court considered defendant’s motion to exclude plaintiffs’ general causation and biostatistics experts.  The Court explained that New Jersey applies a standard less stringent than Frye’s “general acceptance” standard, in determining whether expert testimony is admissible.  Under the guiding Rubanick decision of the New Jersey Supreme Court (125 N.J. 421 (1991)), “if the methodology by which the expert reached a conclusion is sound, the conclusion may be introduced into evidence.”  Accutane, 2015 WL 753674 at *4 (citation to Rubanick omitted).  Later, in Kemp v. The State of New Jersey,  174 N.J. 412 (2002), the Supreme Court held that the trial court was obligated to conduct an evidentiary hearing “any time an expert’s theory has not attained ‘general acceptance,’” and that the failure to do so is “plain error.”  Accutane, 2015 WL 753674 at * 6 (citations to Kemp omitted).  Hence the moniker “Kemp hearing” to describe hearings such as the one that was the subject of the Court’s decision.
To prepare for the hearing, the Court “solicited from counsel all such reports, abstracts, peer-reviewed studies, etc.. . . relied upon by the witnesses in formulating their opinions; said items total in excess of 400 treatises . . . .”  Id. at *2.  Aided by the reports and testimony of defendants’ experts, the Court began its analysis by discrediting the key sources on which plaintiffs’ experts relied.   Based on defendants’ expert’s meta-analysis, the Court stated that “there appears to be little-to-no consensus in the medical/scientific community as to [Accutane’s] correlation to CD and IBD generally.”  Id. at *8.  Corroborating this conclusion were two “extensive review articles” on risk factors for IBD and CD.  The Court commented, “Interestingly, after 30+ years following FDA approval of Accutane, neither of these extensive studies even mentions Isotretinoin as a risk factor.”  Id. at *10.  The Court also noted that plaintiffs’ gastroenterology expert had declined to include comments about Isotretinoin as a possible cause of IBD in a peer-reviewed article he had prepared; however,  before the Court, he was “prepared to say that Isotretinoin is a cause of IBD, yet to a more limited and less informed audience than his peer-reviewed article would have reached.”  Id.   The Court cautioned, “Expert opinions generated as a result of litigation have less credibility than opinions generated as a result of academic research or other forms of “pure” research.”  Id. at *11 (citation omitted).   Against this backdrop, with inevitable skepticism, the Court continued its analysis of the sources relied upon by plaintiffs’ experts.
Epidemiology Studies  
The Court explained that epidemiologic studies “provide the primary accepted methodology for determining a causal relationship between a chemical compound and a set of symptoms or disease.”  Id. (citation omitted), noting that the Reference Manual for Scientific Evidence deems large epidemiological studies to be “some of the strongest medical/scientific evidence.”  Id. (citations omitted).  
We have blogged about the pitfalls of reliance on weak or statistically insignificant associations, in the name of epidemiology, to prove general causation.   Here, the Court wasted little time in discrediting this reliance by plaintiffs’ experts.  After listing the key data produced by nine risk assessment studies and a meta-analysis, the Court concluded,
As discussed in greater detail herein, the information learned from the aforementioned studies together with the testimony of [defendant’s experts] at the Kemp Hearing leads the court to conclude that there is no epidemiologic evidence to justify a reasonable inference that there is a causal link between Isotretinoin and CD. Nor is there any rational basis for Plaintiffs to resist the findings of all the epidemiological studies before the court except for [a single study] comprised of 509 patients. Plaintiffs' criticism of the studies relied upon by Defendant served to highlight the serious weakness of the single study upon which Plaintiffs rely; namely, insufficient numbers to warrant respect by the scientific community. (NOTE: [Plaintiffs’ experts ignore the [study] authors' own conclusions.)   

Id. at *13. 

Reliance on Adverse Event Reports

Noting that, throughout their testimony, plaintiffs’ experts had made reference to spontaneous adverse event reports filed with the FDA, the Court emphasized that the “FDA Adverse Event Reporting System (FAERS) typically yields information that is not evidentiary in a court of law, As the FDA itself notes, there are serious limitations to such information.”  Id., at *14.  In particular, because “FDA does not require that a causal relationship between a product and an event be proven,” “there is no certainty that the reported event . . . was actually due to the product.”  Id.  Further, “FDA does not require reports for every adverse event or medication error that occurs with a product.  Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.  Therefore, FAERS data cannot be used to calculate the incidence” of an adverse event in the U.S. population.  Id.   In addition, “voluntary reporting suffers from chronic underreporting and other biases, and the unknown nature of the underlying population makes true reporting rates difficult to obtain and use for comparisons.”  Id. at *15. 
 
We confess that we snickered at the Court’s final point about adverse event reports, which included a swipe at the plaintiffs' bar.  The Court cited an article describing disproportionate FAERS reporting of IBD cases by attorneys -- of 3.3 million IBD cases reported between 2003 and 2011, attorneys reported a whopping 87.8 %, while physicians reported only 6.0%.  Id. (citation omitted). .  The Court concluded, “The legal profession is a bulwark of our society, yet the courts should never underestimate the resourcefulness of some attorneys.”   (You can read more about the limits of Adverse Event Reports here.)
 Other Criticisms of Plaintiff’s Sources
 Noting that the Reference Manual for Scientific Evidence “ranks case reports at the bottom of the medical evidence hierarchy,” id. (citation omitted), the Court denounced “Plaintiffs’ efforts to characterize case reports as inherently valuable evidence. . . .” Id.  Similarly, the Court discounted studies linking Isotretinoin to intestinal damage in dogs, holding “. . . [T]here are limited occasions in which the information derived from animal studies may be used as an integral link in a chain of evidence in support of a novel hypothesis of a causal relationship, but . . . not in this instance.”  Id. at *16.  
Deficiencies in Plaintiffs' Experts' Methodologies
Having made short work of the sources on which plaintiffs’ experts relied, the Court turned next to criticisms of the experts’ methodologies.  The Court began its attack by commenting, “While both Plaintiffs’ experts are eminently qualified, their reasoning and methodology is slanted away from objective science and in the direction of advocacy.   It is this court’s conclusion that the opinions expressed by Plaintiffs’ experts are motivated by preconceived conclusions, and that they have failed to demonstrate that the data or information they used were soundly and reliably generated and are of a type reasonably relied upon by comparable experts.” Id. at *17 (internal punctuation and citation omitted).  
 Ouch.   And it was downhill from there.   The Court attacked the experts’ reliance on a single risk-assessment study, noting, inter alia: 
  • The study data were collected by questionnaire, which are subject to recall bias and poor recollection;
  • The report of the “study” was published as an abstract in a quarter-page of text, without footnotes.  Neither expert sought to learn any more than was published in the abstract.
  • The number of subjects was small enough to be of little or no epidemiological significance.
 Id.   Most importantly, the study’s authors had concluded that “after adjusting for antibiotic exposure, the risk for IBD following Isotretinoin exposure lost any statistical significance.”  As the Court queried, “If it had lost “statistical significance,” how/why do Plaintiff’s believe it is of any value as a risk assessment? Clearly, it is not.”  Id.  The Court concluded, “The unsound nature of Plaintiffs’ methodology in relying upon such a study becomes readily apparent when compared with the population studies, involving hundreds of thousands of subjects, presented to the court. . . .Yet here again, Plaintiffs’ experts engage in their finely-tuned selectivity of the evidence by disregarding eight of the nine . . . studies.”  Id. at *18.  
 Taking the experts individually, the Court proclaimed that, “[Plaintiffs’ biostatistics expert]’s opinions aren’t methodology based, but are conclusion-driven.  This is an expert on a mission.  As cautioned by our Supreme Court, trial courts must attend to the “hired gun phenomenon.”  Id. at *19.   The Court was even less kind to plaintiffs’ gastroenterology expert: 
 
[He] wants to have it both ways.  First, he wants the Court to reject the best evidence available because he says it is flawed.  Second, he wants the court to accept inferior evidence at the bottom of the medical evidence hierarchy because it is all that he can find to support his hypothesis of causation.  [His] written report itself confirms that his hypothesis is a muddle of ambiguities and that his report camouflages mere speculation as true science. . . . In short, [his] reasoning is a string of ambiguities held together by two insignificant and misused studies, plus convenient assumptions to bridge any analytical gaps that might arise along the way. Such contrived reasoning is not supported by the scientific community as a reliable basis for making causal determinations. 
Id.  at *19-21. 
It is worth one more block quote to include the Court’s lyrical conclusion: 
It is one thing to stand alone in the world of science, advancing a hypothesis that others do not accept. It is quite another thing to advance a hypothesis that can only be supported by disregarding valid scientific research.. . .  [C]oursing through Plaintiffs' presentation is a refrain that is a ruse. . . .  Counsels' sophistry is belied by the fact that the examination of the “lines of evidence” by Plaintiffs' experts was highly selective, looking no further than they wanted to - cherry picking the evidence - in order to find support for their conclusion-driven testimony in support of a hypothesis made of disparate pieces, all at the bottom of the medical evidence hierarchy. This crafty stratagem cannot bridge the analytical gaps inherent in Plaintiffs' hypothesis. 
Id. at *21.   Clearly, New Jersey did not provide a “day at the beach” (or “down the shore,” as we say in Philadelphia) for plaintiffs’ experts.  The Court articulated the relevant legal standards, scrutinized the evidence, applied the law to the evidence with rigor, and reached a conclusion of uncommon correctness and enviable literacy.  It is a shame that we find ourselves surprised by this.  But, every now and then, there is a Beagle. 

 

Monday, March 02, 2015

Statistics Are Still Unnecessary for a Label To Be Adequate

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

*                   *                   *                     *                    *                        *                        *
 
We’ve already blogged about Judge Sweet’s decision last November in the Cymbalta litigation and why it was important.  McDowell v. Eli Lilly, 2014 WL 5801604 (S.D.N.Y. Nov. 7, 2014).  Its most important aspect was Judge Sweet’s holding that the label’s warning of the withdrawal risks associated with discontinuing Cymbalta was sufficient as a matter of law even though it didn’t include the clinical trial statistics that plaintiffs argued should have been included.  The language of the warning was sufficient, so the statistics were unnecessary.  Another important aspect of the decision was the nurse practitioner’s knowledge of the withdrawal risks of Cymbalta, which eviscerated plaintiff’s warnings causation case. 

Judge Sweet had another opportunity to address these same issues just last week.  The plaintiff had moved for reconsideration.  See McDowell v. Eli Lilly, 2015 U.S. Dist. LEXIS 23445(S.D.N.Y. Feb. 26, 2015).  Maybe he shouldn’t have.  The court’s opinion reminds us of the ruling that Lieutenant Commander Galloway received from the bench after her follow-up “strenuous objection” in A Few Good Men.  That ruling triggered this bit of sarcasm from Lieutenant Weinberg as the court was emptying: “I strenuously object?" Is that how it works? Hmm?  ‘Objection.’  ‘Overruled.  ‘Oh, no, no, no. I STRENUOUSLY object.’”

The first time around, plaintiff argued that the warning should have laid out the percentage of patients in the “Perahia” study – 44.3% – who had experienced withdrawal symptoms, rather than the descriptive language in the actual label and the list of identified withdrawal symptoms that had occurred in greater than or equal to 1% of the patient population.  The study and the argument weren’t new issues for the court.  Plaintiff used them in his opposition to summary judgment.  This time he simply attached the study to a belatedly filed expert report.

Similar to Lieutenant Commander Galloway’s strenuous objection, this re-argument offered the court one more chance to announce that the label properly characterized the potential withdrawal risks without those statistics:

This was the express theory of McDowell's complaint . . .  and the precise point made by McDowell's opposition to Eli Lilly's original motion: . . .  The alleged discrepancies between the discussion of discontinuation symptoms in the label and the results of the 2005 Perahia study were considered and it was concluded that, as a matter of law, the label properly characterized the risks. . . . The report by a retained expert does not constitute "new evidence" meeting the high standard warranting reconsideration. 

Id. at *7.  In fact, the warnings section of the label was loaded with information on withdrawal risks:

Discontinuation: May result in symptoms, including dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis, and vertigo (5.6). . . . 

If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that discontinuation can be associated with certain symptoms [see Dosage and Administration (2.4) and Warnings and Precautions (5.6) for descriptions of the risks of discontinuation of Cymbalta]. . . . 

Discontinuation symptoms have been systematically evaluated in patients taking duloxetine. Following abrupt or tapered discontinuation in placebo-controlled clinical trials, the following symptoms occurred at a rate greater than or equal to 1% and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis and vertigo. 

During marketing of other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional instability, insomnia, hypomania, tinnitus, and seizures. Although these events are generally self-limiting, some have been reported to be severe. Patients should be monitored for these symptoms when discontinuing treatment with Cymbalta. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

It’s not difficult to nit-pick even well-conceived warnings after the fact.  We’ve seen plaintiffs’ lawyers do it effectively many times.  Si it’s gratifying to see a court reject this approach.  Twice.

Plaintiff’s reconsideration motion also lobbed a European label into the case.  This is familiar tactic.  Labeling in different countries varies.  Different countries have different regulatory and medical systems.  Plaintiffs almost always try to take advantage of these differences and, for the most part, are rejected by the courts.  Trying such a complex issue is more likely to bog down the trial than provide a jury with material information.  Judge Sweet rejected the use of the European label outright:

The mere existence of a differently structured and written European label does not establish that the U.S. label is insufficient, misleading, or legally inadequate, nor is foreign regulatory action even appropriate as a subject of expert testimony in pharmaceutical cases. 

Id. at *12.

Finally, plaintiff’s reconsideration motion focused on warnings causation and the testimony of the prescriber.  This too was one of the main focuses of the court’s summary judgment opinion.  But the prescriber, a nurse practitioner, had already testified that she knew that Cymbalta carried a significant withdrawal risk and that she would still have prescribed Cymbalta even if the label included the statistics from the Perahia study.  Id. at *14.  That’s bad testimony for a plaintiff.  In fact, it’s case-ending testimony.  So in his reconsideration motion the plaintiff focused on a hypothetical question.  Plaintiff’s attorney had asked the prescriber whether she would have continued to prescribe Cymbalta if she had been told that its withdrawal risk was as bad as or worse than that of a particular competitor drug – and the nurse testified that she might then have chosen a different drug.  Id.  The problem is that there was no support in the record for the hypothetical.  Id.  The court called it a false hypothetical.  Id.  When this type of questioning happens, the defense is forced to highlight the lack of support for the question either at the deposition or (more often) afterward in motion practice.  A good court will then exclude the question.  That’s what Judge Sweet did: 

[T]he absence of any basis in the record for this hypothetical was sufficient reason to exclude it. Plaintiffs in pharmaceutical cases may ask doctors what they would have done in the face of a stronger warning . . . but that hypothetical stronger warning must have a factual basis. 

Id. at *14-15.

The motion for reconsideration didn’t raise anything new other than an opportunity for the court to explain in more detail why judgment should be entered against plaintiff.  The label’s sufficient warning remained sufficient, and the absent warnings causation remained absent.  And the court denied plaintiff’s motion for reconsideration, upholding judgment for the defendant.

Friday, February 27, 2015

Indigestion Inducing Treatment of Class Certification Requirements

            Our occasional claims of dyspepsia may be attributed to various things.  Professional witnesses offering personal opinions from the stand, juries deciding based on emotion and bias, plaintiff lawyers being sleazy, and judges writing decisions driven by a predetermined result or just bad reasoning come to mind.  Sometimes, we recognize that our discomfort stems, at least in part, from the subject matter of a case extending past the reasonable, yet wide and knowingly self-inflated, bounds of our expertise.  Among our hundreds of posts, more than a handful touch on Drug & Device Law in that they (1) involve cases with our clients’ products far from product liability or (2) involve issues we see in our cases being presented in very different types of cases.  While we may throw in some caveats about how we are treading beyond our usual bailiwick, we still offer our views and perhaps even a somewhat blind rant.  Here we are again—personally, this blogger has skipped the last three weeks for trial preparation and denouement—with a decision in a case that is far afield in some respects, but just does not feel right in about every respect.

            The decision of the First Circuit in In re Nexium Antitrust Litig., Nos. 14-1521, 14-1522, 2015 U.S. App. LEXIS 968 (1st Cir. Jan. 21, 2015), affirming a class certification order from the District of Massachusetts is not too surprising if you just consider the courts involved and the name of a drug in the case caption.  If you add that, broadly categorized, this is a third party payor case, then our view that the decision does not make much sense is even less surprising.  The allegation in the case, though, is something we find fairly novel and decidedly weird.  Plaintiffs are “union health and welfare funds that reimburse plan members for prescription drugs”—that is, a type of third party payor—and they claimed that the defendant branded manufacturer of a particular heartburn drug and three putative manufacturers of a generic form of the drug conspired to overcharge for the branded drug when they entered into settlements over patent infringement suits that paid the putative generic manufacturers to not try to get their ANDA approvals and sell their own versions for about six more years.  Are you with us so far?  Not being able to sue under federal antitrust laws because the Supreme Court says indirect purchasers are too remote to have a cognizable injury, the plaintiffs sued under state antitrust laws—adopted by half the union specifically to provide a claim not available under federal law—and state consumer protection laws.  They sued in one federal court (the E.D. Pa.) and the case was moved to another by the JPML.  They sought a class on behalf of everybody in the U.S. or its territories who paid (or will have paid) any money for the drug, including generic versions not yet on the market, for their own use or use by anybody else.  With our caveat about the limits of our expertise, this lead in makes us start wondering about subject matter jurisdiction, personal jurisdiction post-Bauman (especially with the foreign defendants), how third party payors could be class reps for patients who bought their own drugs or for people who bought drugs for their relative, how a court-approved consent judgment could be considered anti-competitive behavior without running afoul of Noerr-Pennington doctrine,  and how there was not some preemption issue in basing state law liability on an assumption that FDA would have approved one to three ANDAs even if there were no patent issues.  Then we took a deep breath and realized that the Nexium decision did not address any of that stuff.  It did note, however, that the defendants had already won a jury verdict at trial this past December, but “[t]his, of course, does not moot the case here given the possibility of further proceedings.”  Then we went back to bellyaching about what else was wrong with the basic premise of this case.  Then we had a drink.  And we don’t mean an antacid.

            The next day, we tried to understand how the class—which admittedly included members without cognizable antitrust injuries—could have been certified and that certification could have been affirmed.  It started with Defendants conceding, perhaps just on appeal, that the familiar requirements of Rule 23(a)—numerosity, commonality, typicality and adequate representation—had been satisfied.  Id. at *15.  The issue on appeal was whether the predominance requirement of Rule 23(b)(3) was satisfied.  To certify a class under this provision, the court must “find[] that the questions of law or fact common to class members predominate over any questions affecting only individual members, and that a class action is superior to other available methods for fairly and efficiently adjudicating the controversy.”  The first thing we look for with a provision like this is burden and Rule 23 does not mention “burden.”  One might assume that the proponent of class certification should be responsible for convincing the court that each requirement is met—allowing the court to make its finding—unless some provision is framed as an exception or defense, which is not the case here.  While the court started by saying the burden was on the plaintiffs—“the party seeking certification must show that ‘the fact of antitrust impact can[] be established through common proof’ and that ‘any resulting damages would likewise be established by sufficiently common proof’” (2015 U.S. App. LEXIS 968, *15 (citation omitted))—it later shifted things so that the plaintiffs only “bear the burden of an initial showing that a proposed class satisfies the Rule 23 requirements” and then “defendants have the burden of producing sufficient evidence to rebut the plaintiff’s showing.”  Id. at *40 (citation omitted).  We looked at Rule 23 again and have no idea how it could have burdens allocated like this, but we also saw that the sage dissent nails the majority for this same burden shifting flim-flam.  Id. at **65-66.  As it often does, the burden shift seems to matter in the result here.
            Jumping ahead, the presence of an indeterminate number of uninjured class members did not alter the finding that common issues predominated:

In light of these three requirements -- ensuring the class is definite, limiting aggregate recovery to the amount of the injury, and ensuring recovery by only injured parties -- it is difficult to understand why the presence of uninjured class members at the preliminary stage should defeat class certification. Ultimately, the defendants will not pay, and the class members will not recover, amounts attributable to uninjured class members, and judgment will not be entered in favor of such members.
Id. at *25.  Without touching on every aspect of the analysis, we can say that getting to this conclusion involved a few leaps.  For instance, the entire analysis as to ascertainability was that “The class definition here satisfies these standards by being defined in terms of purchasers of Nexium during the class period (with some exceptions that also satisfy objective standards).”  Id. at *18.  Ironically, one of the cases cited for “these standards” was Carrera v. Bayer Corp., 727 F.3d 300 (3d Cir. 2013), which we discussed here and slotted at #4 on our 2013 top ten list.  Carrera, however—as the dissent points out, id. at **59-62—did not permit a class membership to be defined by self-serving declarations.  Yet, using such declarations to establish injury—which the court said the defendant could try to rebut, even though there would not be discovery on individual class members—is something the court endorsed.  Id. at **22-23.  That is, unless the court did not just presume that any purchaser was injured, because they would have picked a cheaper generic over a pricier branded drug—again with the non-existent opportunity for rebuttal.  Id. at **22-23.  (The dissent pegged this as an Erie violation in waiting.  Id. at *63 n.31.)  But the plaintiffs need not prove that there was some feasible way to ensure recovery only by those who had been injured, because the defendants had not disproved it was possible.  Absent such disproof, “we have confidence that a mechanism would exist for establishing injury at the liability stage of this case, compliant with the requirements of the Seventh Amendment and due process.”  Id. at *23.  

            The court also determined that the number of uninjured parties in the class was de minimis—or rather, “it has not been shown that the class here includes more than a de minimis number of uninjured parties.”  Id. at **36-37.  Again, we might have thought it the job of the plaintiffs to show that their proposed class was actually a proper class of people/entities with a common injury, because the commonality between injured and uninjured people would tend to be nonexistent.  To get there, though, the court looked at economic experts on each side, with plaintiffs turning to Dr. Rosenthal, a frequent flyer in third party payor cases.  Without getting too deep into the weeds, the defendants identified several situations where a purchaser of the branded drug (with no generics on the market) would not necessarily have paid more than they would have if generics were on the market.  In general, the court concluded defendants did not establish lower average payments in these situations when there were no generics on the market.  However, even Dr. Rosenthal acknowledged that some purchasers—she estimated 5.8% of all prescriptions over a six year period—would have still opted for the pricier branded drug or cheaper generics.  We have to take a second to unpack the court’s conclusion about this group of uninjured class members:  “While on this record it is impossible to precisely quantify the uninjured members in [this group], we conclude that plaintiffs have provided more than enough evidence to meet their Rule 23 burdens.”  Id. at *51.  So, plaintiffs acknowledged uninjured class members related to 5.8% of prescriptions, could not specify that there were only a few such members, and they satisfied their burden (initial burden?) of showing that there were not more than a de minimis number?  Perhaps this is because the court defined de minimis as what is left over if “the vast majority of class members were probably injured.”  Id. at *52.  We do not think there is a definition of “vast majority,” but a legislative “super majority”—which sounds at least as much as a “vast majority”—means two-thirds.  A class with up to one-third of its members without a cognizable injury does not sound like much of a class to us.
            Anyway, this seems to us like another case where procedural mechanisms are being misused to allow a large tax—or at least the threat of a large tax that will itself be expensive to fight off—to be levied against pharmaceutical companies, this time for selling a branded drug developed at great cost for the period of patent protection envisioned in a few federal statutes.  We hope, though, that the relaxed class certification standards seen here would not translate to most other third party payor or consumer protection claims with prescription medical products, as the patent extension theory here did lend itself to looser standards without any attention on the prescription itself.

Thursday, February 26, 2015

Don’t Mix Apples & Bricks – Tincher Didn’t Change Pa. Drug/Device Law

In our initial post about Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), we stated up front that we didn’t think that Tincher changed Pennsulvania law applicable to prescription medical products much, if at all.  We wrote:

For prescription products, the short answer is “not much..” . . . Largely as a result of concerns over liability for scientifically undiscovered risks . . . 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 . . . .  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.

Just because we said so, however, doesn’t make it so.  We’ve learned recently that at least one plaintiff’s lawyer has created an argument for the opposite position – that Tincher supposedly opens up wide vistas of strict liability in prescription medical product cases – and has asserted it in certain medical device litigation in which none of your bloggers are participants.  One of our readers sent us that brief (a publicly filed document) and asked us to comment.

So we will, but we’re not identifying either the case or the plaintiff’s lawyer – if you’re reading, you know who you are.

To us, the plaintiff’s proposition is, in one word, absurd.  It makes no sense that Tincher, which was primarily devoted to moving strict liability design defect cases closer to negligence, would somehow expand strict liability sub silentio (that’s legal Latin for “without explicitly saying so”) in the prescription medical product area, while simultaneously reining it in everywhere else.  There are three fundamental reasons why Tincher cannot be read in that fashion.

First, to do so would mean that the Pennsylvania Supreme Court, in a non-drug case, purported to overrule over 70 years of Pennsylvania precedent barring strict liability (or its equivalents) in prescription medical product liability litigation.

Second, controlling Pennsylvania law prevents such a radical change in existing law from being made by implication in a case not directly presenting the question.

Third, in federal court, where this brief was filed – as we’ve said many times – a diversity based action cannot be a forum for predicting novel expansions of tort liability not already adopted by the relevant state courts.

We’ll address this trio first before turning to some other Tincher- related arguments that those plaintiffs have asserted.

Number one:  Since the dawn of product liability litigation in Pennsylvania, the Pennsylvania Supreme Court has always, whenever the issue was raised (and it’s been raised a fair amount), treated product liability cases involving prescription medical products differently, and has rejected any form of strict liability.  How long has this been going on?  It started in 1942 and was most recently mentioned in Tincher itself (albeit only in passing).

Refusal to apply strict liability began with Henderson v. National Drug Co., 23 A.2d 743 (Pa. 1942), long before the concept of §402A strict liability in tort was even a gleam in a plaintiff’s lawyer’s eye.  In Henderson, the plaintiff failed to prove negligence but claimed that “‘even if the Drug Company was not negligent . . . its product was not safe and therefore on the proof of breach of warranty alone the plaintiff would be entitled to a verdict.’”  Id. at 748-49 (quoting from plaintiff’s brief).  The Pennsylvania Supreme Court unanimously replied:  “[t]his action is not founded on a breach of warranty.  An action against a druggist to recover for personal injuries should be ex delicto and not ex contractu.”  Id. at 749 (citation and quotation marks omitted).

Thus, the “warranty” predicate for the “consumer expectation” prong of the “composite” strict liability design defect test announced in Tincher, 104 A.3d at 401-02, has not existed in Pennsylvania prescription medical product cases since 1942.  As stated in Henderson, pharmaceutical companies are held “to a high degree of responsibility under both the criminal and the civil law for any failure to exercise vigilance commensurate with the harm.”  23 A.2d at 748.  That responsibility remains a negligence duty of care, as eliminating the traditional negligence standard of proof would “ill-serve” the public:

This consideration, however, does not justify the courts in lowering the standards of proof in tort cases of this kind.  If we did so the public interest would be ill served.  If those who make and compound drugs and medicines in packages or bottles, under the strict conditions prescribed by the [forerunner of the Food, Drug & Cosmetics Act], can be mulcted in damages every time some person uses such drugs or medicines with harmful results, the making and selling of such products would be a most peculiarly hazardous enterprise.

Id. (citations omitted) (emphasis added).

Henderson involved what today would be called a warranty of “merchantability.”  More than 20 years later, plaintiffs tried again to impose warranty style strict liability – asserting a “warranty of fitness for use” − against a prescription drug manufacturer in DiBelardino v. Lemmon Pharmacal Co., 208 A.2d 283, 283 (Pa. 1965).  The court reiterated what it had said in Henderson:

[I]n Henderson, disposing of a contention that the drug company would be liable, even if not negligent, if the drug was not safe on theory of a breach of warranty, this Court held that, unless the action is based upon an express warranty, an action against a drug company must be ex delicto and not ex contractu, the action being based upon a breach of duty imposed by law.  Under Henderson, . . . [plaintiff], relying on a breach of implied warranty, would be restricted to an action in trespass rather than an action in assumpsit.

Id. at 585, 208 A.2d at 285-86 (footnote and other citations omitted).  To these Supreme Court cases, we append the more recent Superior Court case of Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374 (Pa. Super. 1987), also emphatically rejecting applicability of implied warranty to prescription drugs.  “[T]he very nature of prescription drugs themselves precludes the imposition of a warranty of fitness for ‘ordinary purposes.’”  Id. at 376-77.

The first modern  – that is, post-§402A – prescription medical product liability case in Pennsylvania was Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971).  Incollingo, in light of the policies expressed by Restatement (Second) of Torts §402A, comment k (1965), reaffirmed Henderson’s holding that negligence was the only viable cause of action in cases involving prescription-only products:

The Restatement reaches the same conclusion as to a product which is incapable of being made safe for its intended use, such as new or experimental drugs, as to which, because of lack of time and opportunity for sufficient medical experience there can be no assurance of safety, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk.  “The seller of such products”, concludes this comment (Comment k), “again with the qualification that they are properly prepared and marketed and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product attended with a known but apparently reasonable risk.”

282 A.2d at 219-20 (emphasis original).  The only proper theory was negligence:

Since the strict liability rule of §402A is not applicable, the standard of care required is that set forth in §388 of the Restatement dealing with the liability of a supplier of a chattel known to be dangerous for its intended use.  Under this section, the supplier has a duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous.

Id. at 220 n.8.

The next Pennsylvania Supreme Court holding rejecting strict liability in a prescription medical product case was Baldino v. Castagna, 478 A.2d 807 (Pa. 1984).  It essentially reiterated what the court had already said about the absence of negligence claims in Incollingo.

In Incollingo we held that, assuming proper preparation and warning, a manufacturer of drugs is not strictly liable for the unfortunate consequences attending the use of otherwise useful and desirable products which are attended with a known but apparently reasonable risk.  Rather, such a manufacturer is liable only if he fails to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous.

Id. at 810 (citations omitted).

Next up was Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383 (Pa. 1991), rejecting a claim of “strict liability independent of the issue of inadequate warning” brought against a pharmacist who had sold a prescription drug.  Id. at 1384.  The Court once again reiterated the “explicit exception” id. at 1385, provided in comment k for prescription medical products:

[Plaintiffs] also argue . . . that [a pharmacist] may be subject to strict liability as a supplier of a defective product. . . .  It is unclear in what sense the appellants contend that the drug was defective beyond that it allegedly carried a risk, of which no warning was given. . . .  It is not alleged that [the drug] was useless for the purpose it was prescribed for, or that it invariably caused the adverse consequences complained of.  It would thus seem that [the drug] is necessarily the type of product covered by comment k of Section 402A, “an apparently useful and desirable product, attended with a known but apparently reasonable risk.”

. . .[T]he fact remains that [the product] is a prescription drug, a product whose distribution is limited precisely because its benefits and risks are to be assessed only by licensed physicians.

Id. at 1386-87 (footnote omitted).  Coyle not only reaffirmed that, under Incollingo, prescription medical product liability was limited to negligence, without dissent it expanded that rationale to include pharmacists, because it would be “incongruous,” id. at 1386, to hold pharmacists to a stricter standard of liability than drug manufacturers.

Five years after Coyle, the Pennsylvania Supreme Court expressly reconsidered – and reaffirmed − its prior holdings about the inapplicability of strict liability to prescription medical products.  Hahn v. Richter, 673 A.2d 888 (Pa. 1996).  The question was expressly whether prior precedent should be overturned, and the result was a resounding “no!”

Incollingo and Baldino, as well as [§402A] comments j and k, make it clear that where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability. . . .  Hence, the trial court properly instructed that [the defendant] could be found liable if [plaintiff’s] injuries were caused by a negligent failure to provide adequate product warnings.  The court did not err in declining to give an instruction on strict liability.

Id. at 891 (citation omitted) (emphasis added).

An allegedly defective prescription medical device (a jaw implant), as opposed to a drug, was at issue in Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521 (Pa. 1995).  The result was the same – a rejection of a strict liability claim.   The no-fault, cost-shifting basis of strict liability was inappropriate where health care providers allegedly acted as intermediate suppliers of medical products during the course of their treatment.  Cost shifting did not justify converting malpractice liability to strict liability.  “To assign liability for no reason other than the ability to pay damages is inconsistent with our jurisprudence.”  Id. at 526.  Cafazzo even presaged Tincher by voicing significant second thoughts about Pennsylvania strict liability:

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

Id. at 527 (citation and quotation marks omitted).  Here, we’ll add Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006), in which the Superior Court specifically held that, for comment k/strict liability purposes, there’s no difference between prescription drugs and prescription medical devices.  See also James v. Stryker Corp., 2011 WL 292240, at *3 (M.D. Pa. Jan. 27, 2011) (in Creazzo, “[t]he Pennsylvania Superior Court extended the holding articulated in Hahn to include medical device cases”); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (same; applying Pennsylvania law).

In 2014, Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), a case we really don’t like on other grounds, the Pennsylvania Supreme Court at least reiterated “this Court’s refusal to extend strict liability to prescription drug manufacturers, consistent with the treatment for ‘unavoidably unsafe products’ reflected in comment k to §402A.”  Id. at 438 (citing Hahn).  “Pennsylvania, ha[s] taken a blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs.”  85 A.3d at 442 n.11.  Due to “the potency of liability in the absence of fault . . . [t]here is greater flexibility . . . with regard to traditional, fault-based liability – i.e. negligence.”  Id. at 452-53 (emphasis original).

[I]n the [Incollingo] line of cases . . ., which have constrained the application of strict liability theory vis-à-vis pharmaceutical companies . . . neither [defendant] nor its amicus references any decision of this Court retrenching from [its] position as it pertains to fault-based liability.  While for policy reasons this Court has declined to extend strict liability into the prescription drug arena, it simply has not immunized drug companies from other governing aspects of Pennsylvania tort law delineating product-manufacturer duties and liabilities.

Id. at 453 (block quote from Incollingo omited) (emphasis added).  Thus, even though we regard the theory of liability allowed in Lance as extreme and unprecedented – in addition to preempted – it is nonetheless solely a negligence theory.

Finally, Tincher itself was not a drug case, but rather involved building products that anyone can buy at the local Home Depot.  To the extent Tincher addressed prescription drugs in its 137 pages, it was to reaffirm existing law.  In the body of the Tincher opinion, the court recognized Pennsylvania law’s long-standing refusal to permit strict liability in prescription medical product cases as an exception to the general principle that “strict liability may be available with respect to any product.”  104 A.3d at 382 (citing Hahn).  In footnote 13 the court described Hahn’s holding as being “where adequacy of warnings associated with prescription drugs is at issue, strict liability is not recognized as basis for liability.”  104 A.3d at 367 n.13.  To the extent that it bears at all on prescription medical products, Tincher is thus best read as a traditionalist opinion.  While Lance contained dictum in footnotes saying nice things about the Third Restatement’s limited absolute liability theories (§6(c)) and critiquing comment k (44 A.3d at 451 n.19, 459 n.37), Tincher effectively retracted those statements – reaffirming §402A, not the Third Restatement, as Pennsylvania law and critiquing “special rules” such as §6(c).  104 A.3d at 364, 394.  See id. at 395 (finding “a question” about “whether the [Third Restatement’s] general and special rules taken together” are “consistent with the public policy” [of Pennsylvania]).  Rather, the Third Restatement “presumes too much certainty about the range of circumstances, factual or otherwise, to which the ‘general rule’ articulated should apply.”  Id. at 398.

Thus, if the footnotes in Lance swung the pendulum somewhat toward the Third Restatement’s version of “strict liability” (not terribly different from negligence) in drug/device cases, Tincher swung it back at least as far in the other direction, rejecting the Third Restatement and its “special rules” in favor of §402A and its accepted comments.

For these reasons, a plaintiff-side argument that Tincher somehow increases strict liability requires “logic” so tied in knots as to resemble a Philadelphia pretzel.  The entire thrust of Tincher was to restrict strict liability, not expand it – and certainly not to expand it at the expense of the longstanding negligence-only basis for prescription medical product liability.  In this way proposition #1, as just discussed, leads directly to proposition #2.  Changing 70 years of established limits on liability in Pennsylvania prescription medical product cases is simply not something that the Pennsylvania Supreme Court would even attempt to do by indirection and implication in an opinion concerning other things.

Number two:  Decisions expanding (or contracting) duties are too important to be left to the kind of tortured logic that plaintiffs struggle mightily to advance.  Rather, as the Pennsylvania Supreme Court stated in in Cafazzo − when plaintiffs last sought to create strict liability in the prescription drug context − “before a change in the law is made, a court, if it is to act responsibly must be able to see with reasonable clarity the results of its decision and to say with reasonable certainty that the change will serve the best interests of society.”  668 A.2d at 527 (citation and quotation marks omitted).

This wariness has hardened into legal doctrine since Seebold v. Prison Health Services, Inc., 57 A.3d 1232 (Pa. 2012).  The court in Seebold outright declared that “the default position [is] that, unless the justifications for and consequences of judicial policymaking are reasonably clear with the balance of factors favorably predominating, we will not impose new affirmative duties.”  Id. at 1245.  Rejecting a proposed expansion of physician warning duties, the Court circumscribed what it called “judicial policymaking,” admitting that such a role is “one to which we are the least well suited.”  Id.  Because “the adjudicatory process is structured to cast a narrow focus on matters framed by litigants before the Court in a highly directed fashion . . . we have often recognized the superior tools and resources available to the Legislature in making social policy judgments.”  Id.

[T]he courts’ reluctance to impose new affirmative duties reflects that the wider field of common-law duties is governed appropriately by existing broad precepts which have been well traveled. . . .  [S]olicitations for new affirmative duties represent exceptions which require concrete and substantial justification.

Id. at 1246.  It “is the Legislature's chief function to set public policy and the courts’ role to enforce that policy, subject to constitutional limitations.” Id. at 1245 & n.19 (citation omitted).

Indeed, in Lance the court relied on these same rules, only targeting defendants rather than plaintiffs.  While we vehemently disagree with the Lance court about who was doing what to established law, the majority reiterated the substantial burden imposed on anyone seeking a change of established law – what allowing strict liability in prescription medical product cases certainly would be.  Proponents of liability changes must support their arguments with evidence.  “Whatever . . . the subject may be, Seebold makes clear that, going forward, we are not inclined to act instinctively or intuitively.”  44 A.3d at 455.  Rather:

[T]he proponent of a new duty regime [must] present a full and balanced record covering the range of relevant policy matter. . . .  Without any treatment of [the] incentives and other variables which [the proponent] omits and/or understates, we have no means of reasonably evaluating the impact of maintaining liability [on the facts of this case], which must be accepted as true for present purposes.  In these circumstances, we are simply unable to conduct the sort of overarching policy assessment essential to the vindication of [the proponent’s] position.

Id. (footnotes omitted).

In Conway v. The Cutler Group, Inc., 99 A.3d 67 (Pa. 2014), the Court sounded similar themes in declining to expand liability under the implied warranty of habitability for reasons of “public policy.”

[T]he courts’ authority to declare public policy is limited.  In our judicial system, the power of courts to formulate pronouncements of public policy is sharply restricted; otherwise they would become judicial legislatures. . . .  If, in the domain of economic and social controversies, a court were, under the guise of the application of the doctrine of public policy, in effect to enact provisions which it might consider expedient and desirable, such action would be nothing short of judicial legislation.

Id. at 72-73 (citations and quotation marks omitted).

In Tincher, the court expressed similar concerns in explaining why, after junking the old Azzarello version of strict liability, it was leery of adopting the Third Restatement.  “This Court has grown more careful over the years when presented with invitations to issue broad-based pronouncements in areas where it is apparent that such pronouncements are better suited to the information-gathering and give-and-take balancing of competing concerns available in the legislative arena.”  104 A.3d at 352-53.  The “preferable solution” was for “the General Assembly [to] address this arena of substantive law,” id. at 381, but until that happens, the Court opted for a more “modest” result.  Id. at 378 (referencing “the necessity of reading legal rules − especially broad rules − against their facts and the corollary that judicial pronouncements should employ due modesty”).

In light of the Pennsylvania Supreme Court’s approach to arguments for changing established law, it is ludicrous for plaintiffs to contend that 70+ years of refusal to apply strict liability to prescription medical products could be changed by inference in Tincher – a case that did not even involve such products.  As the Seebold line of cases makes abundantly clear, the “default” position is existing law.  For plaintiffs’ argument to have even a chance of prevailing, they would have to muster full proofs, supported by policy-related materials on the order of what a legislative committee would generate.  The plaintiff’s brief we’ve seen doesn’t even try, and instead relies solely on general quotes from Tincher taken woefully out of context.

Number three (and mercifully shorter than the previous two):  The brief that we’ve seen was filed in, of all places, a federal court.  Not only are plaintiffs trying to undo 70+ years of unbroken Pennsylvania precedent – and not only have they provided no policy-grounded justifications for doing so – but they’re trying to get a federal judge sitting in diversity to predict their postulated dramatic expansion of strict liability.  Under Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938), that’s blatantly improper.

Federal courts, exercising diversity jurisdiction, are particularly ill-suited to entertain arguments asserting novel, state-law theories of liability.  We’ve made this point over and over in the posts under our Erie doctrine blog topic.  Since federal courts borrow, and do not make, state law, they rightly should be reluctant to predict drastic legal changes, particularly liability expansion.  The Supreme Court so held in Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3 (1975).  “A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.”  Id. at 4.

We’ve already gone through this exercise before, specifically with respect to the Third Circuit (which includes Pennsylvania).  We’ll give only the thumbnail version here.  In Sheridan v. NGK Metals Corp., 609 F.3d 239 (3d Cir. 2010), the court pointed out that “[a] federal court under Erie is bound to follow state law as announced by the highest state court.”  Id. at 253.  “Unlike our role in interpreting federal law, we may not act as a judicial pioneer” because “[f]ederalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law.”  Id.  The court reiterated in Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238 (3d Cir. 2010), that, “in reaching our conclusion we have exercised restraint in accordance with the well-established principle that where two competing yet sensible interpretations of state law exist, we should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of that state decides differently.”  Id. at 253.  Accord, e.g., City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002); Camden County Board of Chosen Freeholders v. Beretta, 273 F.3d 536, 541 (3d Cir. 2001); Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994); City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993).
 

*          *          *          *
So that’s three fundamental reasons right off the bat why arguments that Tincher somehow allows strict liability in the context of prescription medical products are bogus.  (1) Strict liability has never existed in prescription medical product cases under Pennsylvania law, and no fewer than eight Pennsylvania Supreme Court decisions have refused to apply it over the last 70+ years.  (2) Such a huge change in the law would require a factually-based policy rationale and cannot be done by inference.  (3) Federal courts lack the authority to predict liability-expanding deviations from current state law.  While we really don’t think plaintiffs should get more than three strikes, there are still more reasons why their Tincher-based contentions are not to be believed.

Most notably, the plaintiff-side brief we’ve seen relies heavily on California law.  Admittedly, Tincher mentions a number of general California cases.  Most prominent are the Azzarello-era Barker v. Lull Engineering Co., 573 P.2d 443 (Cal. 1978), which adopted a somewhat analogous dual-track approach to strict liability, and the more recent Soule v. General Motors Corp., 882 P.2d 298 (Cal. 1994), decision that among other things put the brakes on the consumer expectation prong.  See Tincher, 104 A.3d at 378, 388-89, 391-93, 398-99, 403, 406-09.

Plaintiffs contend that Tincher’s citations to these two California cases somehow creates a strict liability action against a medical device in Pennsylvania.  Their rationale is that Soule discussed an even older California intermediate appellate medical device case, West v. Johnson & Johnson Products, Inc., 220 Cal. Rptr. 437 (Cal. App. 1985), that allowed a consumer expectation claim.  Notably, Tincher nowhere cited to West.  That connection was invented by the plaintiffs.

Looking at these cases on Westlaw reveals that, in fact, West was “called into doubt” by Soule – precisely on the consumer expectation issue.  See Soule, 882 P.2d at 308 (“the consumer expectations test is reserved for cases in which the everyday experience of the product’s users permits a conclusion that the product’s design violated minimum safety assumptions, and . . . the minimum safety of a product is within the common knowledge of lay jurors”).  Indeed, since Soule, California’s consumer expectation test has been held inappropriate even for non-prescription medical devices.  See Morson v. Superior Court, 109 Cal. Rptr.2d 343, 358-59 (Cal. App. 2001) (due to “complex nature” of latex gloves, and alternative causes of injury, consumer expectation theory was properly dismissed).

But there’s an even more serious problem with plaintiffs’ analysis than one of their California cases essentially overruling another.  1985 is a long time ago, and plaintiffs do not acknowledge that, since West, the California Supreme Court has agreed with Pennsylvania and abolished strict liability design defect claims altogether in prescription medical product cases.  Everyone who does this kind of work knows the decision – Brown v. Superior Court, 751 P.2d 470, 475-76 (Cal. 1988) – so it can’t be accidental that the plaintiffs omitted it altogether from their purported comparison of California and Pennsylvania law.

Relying, as has Pennsylvania, on comment k, the Brown court outright rejected strict liability design defect claims:

We shall conclude that (1) a drug manufacturer’s liability for a defectively designed drug should not be measured by the standards of strict liability; (2) because of the public interest in the development, availability, and reasonable price of drugs, the appropriate test for determining responsibility is the test stated in comment k; and (3) for these same reasons of policy, we disapprove the holding . . . that only those prescription drugs found to be “unavoidably dangerous” should be measured by the comment k standard and that strict liability should apply to drugs that do not meet that description.

Id. at 477 (emphasis added).

Brown was a drug case, but the same standard has been repeatedly applied to medical devices under California law, most recently a couple of years ago.

[T]he reasoning of Brown and Hufft applies to an implanted medical device in these circumstances regardless of whether, strictly speaking, it was available only by prescription and regardless of whether it is properly characterized as a “prescription” implanted medical device.  The public interest in the development, availability and affordability of implanted medical devices justifies an exemption from design defect strict products liability for all implanted medical devices that are available only through the services of a physician.

Garrett v. Howmedica Osteonics Corp., 153 Cal. Rptr.3d 693, 701 (Cal. App. 2013); see also Artiglio v. Superior Court, 27 Cal.Rptr.2d 589, 593 (Cal. App. 1994) (“follow[ing] the lead of the Hufft and Plenger courts, and conclud[ing] that the entire category of medical implants available only by resort to the services of a physician are immune from design defect strict liability”); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 818 (Cal. App. 1992) (court was “unable to make any principled distinction in terms of policy considerations between prescription drugs and prescription implanted medical devices”); Hufft v. Horowitz, 5 Cal. Rptr.2d 377, 378 (Cal. App. 1992) (“the compelling public policy reasons articulated by the Brown court with regard to prescription drugs apply with equal force when the product is an implanted medical device”).  In sum, the argument that a California law analogy supports expansion of strict liability in drug/device cases is every bit as meritless as plaintiffs’ main argument under Pennsylvania law.  There is no such thing as a “strict liability” design defect cause of action in California where the product is a prescription drug or medical device.

We would be remiss – not nearly as remiss as plaintiffs in ignoring California drug/device-specific law, but remiss nonetheless − if we did not acknowledge that California law does allow what it calls “strict liability” in warning cases involving prescription products.  See Carlin v. Superior Court, 920 P.2d 1347, 1350-54 (Cal. 1996).  But what California calls “strict liability” doesn’t resemble what Pennsylvania law, at least pre-Tincher, considered “strict liability.”  Warning claims in California are governed by a “knowledge or knowability requirement [that] infuses some negligence concepts into strict liability.”  Carlin, 920 P.2d at 1350.  Compliance with governmental, i.e., FDA, standards is also admissible and in proper cases can preclude “strict” liability.  “[I]n the case of an alleged ‘known’ risk, if state-of-the-art scientific data concerning the alleged risk was fully disclosed to the FDA” and if the FDA authorized no warning “because the data was inconclusive or the risk was too speculative . . . the manufacturer could present such evidence to show that strict liability cannot apply.”  Id. at 1353.  Thus, prescription medical product warning claims in California correspond to “negligence” claims in Pennsylvania.

Plaintiffs try desperately to create some kind of distinction between prescription drugs and medical devices.  Their efforts are to no avail.  We’ve already posted on how prescription medical devices are equally governed by the learned intermediary rule as prescription drugs, citing dozens of cases in dozens of states.  While we haven’t done a similar post demonstrating the same congruity between drugs and devices with respect to comment k, that’s true as well.  For now, we’ll simply refer everyone to §2.02[2] of Bexis’ book, and in particular to the literally scores of cases in footnote 14, along with Haffner v. Stryker Corp., 2014 WL 4821107, at *2-3 (D. Colo. Sept. 29, 2014), which is the latest case we know to have applied comment k equally to a medical device design defect case.  The consensus is simply overwhelming that, as far as applicable legal principles are concerned, all prescription medical products are treated the same.

Finally, we come to the issue of “strict liability” manufacturing defect claims.  As we’ve already pointed out in a post last year, after the Supreme Court in Lance reaffirmed prior law precluding strict liability in prescription medical product cases, movement towards allowing “strict liability” manufacturing defect claims in this area has stopped.

Plaintiff contends that Hahn does not prevent strict liability claims based on manufacturing defects.  This Court does not agree.  Although federal courts are currently split on this issue of whether 402A applies to medical devices, and some allow strict liability claims to proceed when a manufacturing defect is alleged, the decisions of these courts pre-date Lance.  There, the Pennsylvania Supreme Court reiterated the principle that a strict liability claim based on a defective prescription drug is barred.  In explaining this principle, the Court did not exempt from this bar a claim based on a manufacturing defect.  Based on the above, this Court predicts that the Supreme Court of Pennsylvania would come to the same conclusion with respect to defective medical devices.

Terrell v. Davol, Inc., 2014 WL 3746532, at *5 (E.D. Pa. July 30, 2014).  In particular, Terrell disagreed with Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 1760525 (M.D. Pa. Apr. 24, 2013), and Doughtery v. C.R. Bard, Inc., 2012 WL 2940727 (E.D. Pa. July 18, 2012), both of which allowed strict liability/manufacturing defect claims, since both cases expressly relied on the Superior Court’s Lance opinion (Bergstresser, at *3; Doughtery, at *4), that the Supreme Court has since reversed at the same time it was reaffirming the no-strict liability rule.  Terrell, at *5 n.8.

In sum, now that we have researched the [fill in the blank with a Nixonian expletive] out of the issue, we are more convinced than ever of the correctness of  our initial assessment that Tincher should have only minor impact on current Pennsylvania prescription drug and medical device product liability law.  It’s very simple.  Tincher completely revamped strict liability, but strict liability does not apply to prescription medical products in Pennsylvania and never has – in any form.