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.

Wednesday, February 25, 2015

Guest Post - Charlton in Charge: British Columbia Court of Appeal Overturns Pharmaceutical Class Action Certification Due to Plaintiff’s Failure to Provide Workable Causation Methodology

What follows is a guest post about a significant class action decision in Canada.  Our guest poster today is Chris Horkins of the Canadian firm Cassels Brock & Blackwell LLP.   We haven't changed a thing, not even Canadian-style spelling, so as always our guest poster gets all the credit, and any blame, for what follows.


Canadian courts may be taking a firmer stance against certification in pharmaceutical class actions. The recent decision of the British Columbia Court of Appeal setting aside the certification of a pharmaceutical class action in Charlton v. Abbott Laboratories Ltd. 2015 BCCA26 [Charlton] provides evidence of a growing trend in favour of defendants in prescription drug class actions in Canada. Although the certification test in most Canadian jurisdictions remains a procedural question, it is clear that courts will require plaintiffs to show that causation is capable of being proven on a class-wide basis before giving the green light to a proposed class action.

History of the Proceedings

The Charlton class action against pharmaceutical manufacturers Abbott Laboratories, Ltd. (“Abbott”) and Apotex Inc. (“Apotex”) was commenced on behalf of patients across Canada who had used or purchased the prescription drug sibutramine, alleging that the drug increased the risk of cardiovascular events such as heart attack and stroke. The plaintiffs alleged that the defendants were liable in negligence, waiver of tort and for breaches of Canada’s Competition Act and British Columbia’s Business Practices and Consumer Protection Act.

Originally developed as an anti-depressant, sibutramine was found to suppress appetites in its use for that purpose. Subsequently, Meridia, a weight-loss drug was developed by Abbott and approved for use in Canada in late 2000. In 2009, Abbott’s exclusive right to distribute Meridia ended and Apotex began distributing a generic weight loss drug containing sibutramine under the name Apo-Sibutramine. In 2010, a US medical journal published a study suggesting that sibutramine was associated with an increased risk of serious cardiovascular events for patients with pre-existing heart conditions. Shortly afterwards, the drugs were voluntarily taken off the Canadian market by Abbott and Apotex.

Decision of the BC Supreme Court

At first instance, the BC Supreme Court certified the action as a class proceeding under BC’s Class Proceedings Act. The certification judge noted that his role was not to test the merits of the action, but rather to focus on the form of the action and whether it was appropriately prosecuted as a class action. Applying the low threshold “some basis in fact” test from the Supreme Court’s leading decision in Hollick v. Toronto (City) [2001] 3 S.C.R. 158, 2001 SCC 68, the court certified the proposed class action.

Decision of the BC Court of Appeal

On appeal, the BC Court of Appeal overturned the certification order, finding that the plaintiffs had failed to adduce evidence of a workable methodology to determine the issue of general, class-wide causation – namely, that sibutramine actually increased the risk of cardiovascular events for all class members. Since the only evidence before the court was the study suggesting an increased risk for patients with pre-existing heart conditions, the court found there was no viable methodology for determining causation with respect to the wider class:

While there is no dispute that those with pre-existing cardiopulmonary disease are at a statistically increased risk of adverse cardiac events, this is not a case where the experts disagree on the extent of the risk, but rather, a case where the experts are uncertain whether there is a risk to the class as a whole and cannot describe a methodology for addressing that question.
This was found to be a necessary element of proof for each of the certified common issues. As such, the question of causation was incapable of resolution based on the evidence at the certification hearing. Accordingly, the Court of Appeal found it was an error for the certification judge to have certified the class action and set aside the certification order.

Implications Going Forward

What can product liability class action defendants take away from this decision? It demonstrates how arguments relating to the merits can be imported into the certification test and used to defeat certification. As Justice Willcock stated: “The question that ought to have been asked at the certification hearing in relation to both types of claims, is not whether the resolution of the general causation question will advance the class claims, but rather, whether there is a reasonable prospect of doing so.”  The failure of plaintiff’s counsel to put forward viable evidence of class-wide causation can be considered a failure to demonstrate causation on a class-wide basis and that a class action is the “preferable procedure.”

Viewed together with the Ontario Divisional Court decision in Martin v. Astrazeneca Pharmaceuticals PLC, 2013 ONSC 1169, the Charlton decision demonstrates a shift to a stricter and more thorough analysis of proposed class action claims.

Tuesday, February 24, 2015

Off-Label Promotion Allegations Trounce Fraudulent Joinder

            Do we say often enough how much we dislike off-label promotion theories of liability?  It has its own section on the blog and on a quick skim through you will find traditional products liability cases, qui tam False Claims Act cases (and the subsidiary First Amendment litigation), securities fraud litigation, criminal actions, and third-party payer suits.  There are probably others, but we stopped scrolling.  The point is that just about everyone who wants to sue anyone in the pharmaceutical and medical device world has at some time tried to use off-label use and promotion to get the job done. 

            The fact that what is and is not permissible off-label promotion remains a question doesn’t help matters.  Really, it is what drives the vast scope of off-label litigation.  And one of the primary problems is the confusion between truthful and untruthful off-label promotion. When courts, in our opinion, get it wrong is when they refuse to recognize that distinction.  Simply because something is considered off-label promotion (addresses a use or indication not on the product’s approved labeling) doesn’t make it false, misleading or untruthful.  This is where we think the court got tripped up in Hricik v. Stryker Biotech LLC, 2015 U.S. Dist LEXIS 11714 (E.D. Pa. Jan. 30, 2015).

            Plaintiff brought products liability claims against the manufacturer of a spinal fusion device and two of the manufacturer’s sales representatives.  The reps are residents of Pennsylvania and therefore, their presence in the suit defeats diversity jurisdiction unless they were fraudulently joined.  The defendant manufacturer made that very argument. 

                  The primary claims against the sales reps are for negligence and fraud.  Id. at *9.  The supporting allegations for those claims are that the reps promoted the spinal fusion device for an unapproved use.  Id. at *8.  The question for the court was whether plaintiff had stated a colorable claim against the sales reps such that the reps were not fraudulently joined and that the case should therefore be remanded to state court.  Under Pennsylvania’s “participation theory” of individual liability, the plaintiff must establish that the individual agent engaged in misfeasance rather than mere nonfeasance.  Id. at *14.  In other words, the sales reps must have engaged in affirmative bad acts.  Defendants directed the court to numerous examples of cases where the claims against the sales reps were dismissed or found not actionable (cited in the opinion), but the court chose to distinguish them on the grounds that they did not contain sufficient allegations of misfeasance as opposed to nonfeasance.  Id. at *16. 

            We didn’t go back and parse through all those other decisions, but we wouldn’t be surprised if the single biggest difference between them and the current case is off-label promotion.  And apparently off-label promotion, in and of itself, was enough for this court to find misfeasance.  For example, the court concluded that plaintiff’s fraud claim against the sales reps was colorable because the complaint identifies alleged misrepresentations relied on by plaintiff’s surgeon.  Id. at *18.  But does the complaint actually allege a false statement?  Or does it allege that the sales reps promoted the use of the product in combination with another product and that such use is considered off-label?  Id. at *18-19.  We see off-label, but we don’t see untruthful.  And untruthful is what you need for a fraud claim. 

            As for plaintiff’s negligence claim against the sales reps, the court falls back on the unfortunately overly broad interpretation of negligence under Pennsylvania law (see our discussion of Lance here).  Using Lance as a springboard, the court finds that Pennsylvania would recognize a negligent off-label promotion claim:  “there is a colorable basis for a claim that sales representatives have a duty to refrain from affirmatively misrepresenting the safety and efficacy of devices for uses for which they have not been approved.”  Id. at *24.  But the court seems to be assuming that any statement about an off-label use is a misstatement and that simply is incorrect.  As many courts have recognized, off-label use can often be the medical standard of care.  A product’s approved labeling necessarily lags behind scientific developments meaning that discussions, statements or representations about the state of the science can be both off-label and completely truthful and accurate.  That’s the rub that challenges the FDA.  That’s the rub that is challenged in the First Amendment cases.  That’s the rub on preemption.  That’s the rub.