A Not So Bad Blast from The Past

            We saw the news yesterday about DePuy discontinuing two of their lines of hip implants, which have been involved in some litigation.  While we are not ignorant of the impact of litigation on business or the impact of discontinuation/withdrawal/recall on litigation, we do hate to see situations where the availability of useful medical products can be affected by the number of lawsuits drummed up through waves of lawyer advertising.  We do not know the merits of the cases involving these products, except to the extent we have seen some decisions on pleading and preemption, but we do know we see ads to bring suit about these products everywhere we turn, even as annoying pop-ups on “free” apps.  We ran across a case approaching consideration of the merits on a case involving another one of DePuy’s hip implant products.  In Rydzewski v. DePuy Orthopedics, Inc., No. 11-80007-Civ-Williams, 2012 U.S. Dist. LEXIS 187963 (M.D. Fla. Aug. 14, 2012), most but not all of plaintiff’s claims were kicked on summary judgment.  (You ask why we post now on a decision from 9 months ago.  Well, first, we do what we want, and, second, it was just “published” by Lexis last week.)

            When we started reading the Rydzewski decision, we thought we were not going to like it.  As we have said before, the language the court uses to describe the plaintiff and his/her injury often foretells the result.  Here, the plaintiff was described as “6’1” in height and 230 pounds in weight, and [] a physically active police officer,” and his alleged injury was described as “when the femoral stem of the device fractured, disabling him and causing severe pain . . .  [and s]ince that time [plaintiff] has experienced constant pain and significant physical limitations.”  We say “alleged injury,” but the court did not use that qualifier.  Nor did it need to describe extent of plaintiff’s damages to rule on a fairly straightforward motion for summary judgment based on whether plaintiff had established a prima facie case for any of his asserted causes of action.

            When the court denied the motion as to design defect without any explanation of the proffered evidence, we thought we had read the omens correctly.  (We are not sure if  this process is more like reading entrails, tea leaves, bird flight patterns, thrown bones, or some other esteemed method of prognostication.)  The plaintiff alleged that the design defect related to the product’s “unacceptably low safety strength factor” and had two experts to say that “a design defect caused the device to undergo premature fatigue failure,” “that there was no practical justification for the defective design” and “that alternative safer designs were available.” Id. at **4 & 9.  The court did not mention the experts’ qualifications, basis, reasoning, or even whether the defect they opined on was that “unacceptably low safety strength factor” thing.  As we see later in the decision, the issue really seems to be whether the product was strong enough for someone with plaintiff’s size and activity level.  We cannot tell from the decision whether the plaintiff’s experts actually supported a defect along those lines, but the court said they did −  not only enough to create a genuine issue of material fact as to a design defect under the risk utility test, but also to overcome any presumption against defect from the Florida statutory Government Rules Defense.  Id.  The court did not decide whether that defense applied to the case.  Nor did it decide whether “the consumer expectation test is still an independent basis for finding a design defect under Florida law” given that the test was dropped in the Third Restatement—it merely “assume[d]’ that it was.  It did, however, conclude that the consumer expectation test did not apply for a complex implantable medical device, which may be helpful in other cases.  Id. at **8-9.

            After this shaky start, the court proceeded to knock out a manufacturing defect claim.  That was largely because the plaintiff did not try to justify the claim in his summary judgment response.  Then the court turned to claims for implied warranty.  Florida requires privity, which you typically do not have for medical devices.  Plaintiff tried to say that the privity requirement was satisfied because he was a third-party beneficiary of some sales contract, but the court pointed to Florida law requiring that “the parties to the contract clearly express . . . an intent to primarily and directly benefit the third party or a class of persons to which that party claims to belong.”  Id. at * 12.  Plaintiff—and, we suspect, the vast majority of device plaintiffs--could not satisfy that standard, so the implied warranty claims were gone.  The tea leaves for the remaining negligence claim were not looking so grim (or Grim).

            The main hurdle in evaluating the negligence claim seemed to be determining what negligence was being asserted, challenged by defendant, and argued by plaintiff.  The count seems to have been drafted like the typical kitchen sink negligence claim, with parts sounding in negligent design, negligent failure to test, negligent failure to warn, and negligent manufacturing.  Defendant said they were only moving on the warnings part and then plaintiff took the position that he had not asserted and did not really resist summary judgment on warnings.  The court proceeded to grant summary judgment on negligent failure to warn without addressing other negligence theories.  We do not quite get it, particularly how negligent manufacturing could survive where plaintiff did not even try on manufacturing defect, but that is what happened.  The warnings analysis was pretty solid.  Contrary to what we saw with the discussion of the expert evidence on design defect, the court did what it was supposed to and looked closely at the proffered evidence.  The same expert who helped carry design defect could not raise a genuine issue on the adequacy of warnings because his affidavit amounted to “unsupported factual assertions” due to lack of citations and detail.  Id. at *18.  The court even went to the expert’s report, maybe sua sponte, to spot inconsistencies with his affidavit.  In a clear statement of how warnings claims should be analyzed, the court found:

The warnings quoted above accurately, clearly, and unambiguously provide that excess body weight and activity level can adversely affect the device, and that the largest device possible should therefore be used.  The Plaintiffs offer no explanation as to how the warnings in this case were inaccurate, unclear, or ambiguous, and in this respect they correctly acknowledge that the adequacy of warnings can be a question of law.  Thus the Court finds that the Plaintiff have not produced sufficient evidence to create a genuine issue of material fact regarding the adequacy of the warnings provided to [the surgeon.]

Id. at **19-20 (citation omitted).

            Not surprisingly, the plaintiff also failed on proximate cause.  The experienced surgeon knew all the pertinent risks and never read the package insert, so there were two problems for plaintiff.  He did “not explain what additional warnings not within [the surgeon’s] independent knowledge should have been provided” and “it is unclear how the inclusion of additional warnings in the insert would have prevented the incident.”  Id. at *21.  We certainly appreciate it when courts take proximate cause seriously and do not let plaintiffs get by on speculation and assumption.  So, the negligent warnings claim was gone too.

            With a nod towards old SNL, now is the time on “Sprockets” when we second-guess.  We have not checked the briefs or docket here, so our three hindsight observations should be taken as such.  We are not sure why the attack on the negligence claim was not broader.  Plaintiff clearly did not have negligent manufacturing evidence, and the failure-to-test theories (even if cognizable) were going to run into the same proximate cause problems as the warnings claim, which was largely based on failure to test evidence anyway.  Also, we are not sure why some of this was not sorted out on a motion to dismiss.  Clearing out counts or portions of counts that were impermissibly vague or not allowed under Florida law might have narrowed the target for summary judgment.  And, lastly, this may be the only summary judgment decision we have read on an implantable surgical device that does not mention preemption.  We are not saying how that would have gone here—Class II, we think, in the Eleventh Circuit—but design defect under a risk utility test can smack up against preemption.  Anyway, not so bad as is.  And, no, you cannot touch our monkey.

Polett To Be Reargued En Banc

We previously blogged about the Pennsylvania Superior Court vacating an 8-figure in Polett v. Zimmer and remanding for a new trial due to multiple reversible errors committed at the first trial.  Unfortunately, nothing's ever easy in our extremely pro-plaintiff Superior Court.  We've been informed that Polett will now be reargued before the entire en banc court, so we don't want our readers to have any misimpression as to the status of the case.  Keep your fingers crossed.

Publisher Liability Rejected By Philadelphia C.P. Court

Some time ago we were highly critical of a potentially dangerous expansion of liability for failure to warn to publishers of medical literature.

That’s right, publishers.

In our prior post we went after Slater v. Hoffman-La Roche, Inc., 771 F. Supp.2d 524 (E.D. Pa. 2011), for giving credence to a claim that a publisher of medical reference products could somehow be liable under Pennsylvania law for alleged errors and omissions in the content of materials written by others.  Slater did not say that there was such a claim, mind you.  It only speculated (in the absence of any contrary precedent) that there could conceivably be such a claim.  Slater was an fraudulent joinder case.  The publisher defendant, Wolters Kluwer, had the misfortune of being headquartered in Pennsylvania.  That meant it was non-diverse, so if the plaintiffs could merely hang a “colorable” claim on it, the case would have to be remanded to the Philadelphia Court of Common Pleas – at the time the #1 ranked Judicial You-Know-What accordingto ATRA.

Philadelphia isn’t ranked #1 anymore.

The Philadelphia Court of Common Pleas Complex Litigation Center (home to Philly’s notorious mass tort programs) is under New management.

As in Judge Arnold New.

Judge New recently issued an opinion, A.B. vs. Ortho-McNeil-Janssen Pharmaceuticals, 2013 Phila. Com. Pl. Lexis 84 (Pa. C.P. Phila. Co. April 5, 2013), sticking a much deserved fork in the concept of publisher liability.  A.B. involved alleged injuries from certain atypical antipsychotic drugs.  In addition to the manufacturer of the drug, the plaintiffs sued two publishers of medical information, Excerpta Medica and Elsevier.  The publishers recently took the bull***t by the horns and moved for summary judgment, on the ground that their role in “publishing scholarly books and journals” (Elsevier)  and “developing medical literature . . . including articles published in peer-reviewed journals and posters and abstracts presented at medical conferences” (EM), id.,  at *4-5, couldn’t possibly give rise to liability to the plaintiff.

According to the plaintiffs:

All claims against [the publishers] were premised on allegations Defendants “affirmatively misled the medical community regarding the severe side effects of [the drugs] in connection with promoting, marketing, distributing, labeling and/or sale of the prescription drugs.

Id. at *7-8.

And thus the issue was joined.

The court held that with respect to negligence, whether Pennsylvania (the forum) or Texas (where the plaintiff took the drug – A.B. was another litigation tourist case) law applied, the result would be the same, because there were no relevant differences in the law of the two states, at least as to the plaintiffs’ negligence-based claims (which also permeated the other claims).  Id. at *17.

Plaintiffs predicated negligence liability on one of those garbage-scow theories – “negligent undertaking” under Restatement (Second) of Torts §324A (1965).  That theory is otherwise known as the “Good Samaritan rule,” because it's so potentially broad that even the biblical Good Samaritan could be liable under its broad provisions.  Id. at *15.  Supposedly, the publishers “fail[ed] to use reasonable care in their undertaking to provide accurate, up-to-date information about [the drugs].”  Id. at *16.  Remember, the defendants are publishers.  They made no substantive inquiry into the materials that they published.  They didn't research; they set type, or whatever is the 21st Century equivalent.

The claim went down in flames.  First of all, “No liability is recognized under §324A(c) for allegations of nonfeasance.”  Id. at *18 (citations omitted).  Publisher liability is a pure nonfeasance claim.  Publishers have never had legal responsibility, nor have they assumed such responsibility, for ensuring the accuracy of everything that they publish.  There are persons who have such responsibilities – they’re called “authors” – but authors:  (1) are protected by the First Amendment, and (2) in the case of drug-related information, usually also the manufacturers of the drugs, which can be sued directly for failure to warn.  As to publishers, “that the actor realizes or should realize that action on his part is necessary for another's aid or protection does not of itself impose upon him a duty to take such action.”  Id. at *19 (quoting Restatement (Second) of Torts §314).

Without a duty, there can’t be liability:

Before a person may be subject to liability for failing to act in a given situation, it must be established that the person has a duty to act; if no care is due, it is mean-ingless to assert that a person failed to act with due care.

A.B., 2013 Phila. Com. Pl. Lexis 84, at *20 (quoting Wenrick v. Schloemann-Siemag Aktiengesellschaft, 564 A.2d 1244, 1248 (Pa. 1989) (a component part supplier case)).

There was simply no duty.  The publishers did not make or sell the drugs.  A.B., 2013 Phila. Com. Pl. Lexis 84, at *21.  While manufacturers have duties to warn about drugs, publishers to not assume them merely by publishing information written by drug companies.  A publisher (here, EM) who works with a drug company is “not responsible for vetting the accuracy of the medical information contained in the articles, posters and abstracts on [which it] worked.”  Id. at *22.  Such a duty would be unprecedented, even in the context of medical researchers:

[A] review of these cases and independent research reveals our sister states generally find no duty exists between clinical researchers and the consumers in the context of prescription product-liability litigation because independent laboratories have no duty of reasonable care towards parties with which they did not contract.

Id. at *24.  Publishers “d[o] not participate in . . . clinical study” of drugs, nor do they have “access to clinical data.”  Id. at *28.  Nor did the publishers go beyond putting materials together based upon what they were given by the drug manufacturer:

Plaintiffs . . . have produced no evidence to show the [manufacturer] granted or delegated to [the publisher], in whole or in part, the authority to submit for publication any such materials without the [manufacturer’s] and the independent authors’ final review and approval.  Rather . . . the [manufacturer] maintained absolute control over the scope of [the publisher’s] services. . . .  [The publisher] was not the “gatekeeper” of the publication and distribution of information related [the drugs]. The [manufacturer] and independent authors maintained the ultimate discretion in the information included or omitted from [the publisher’s] drafts and thus, were responsible for vetting the medical accuracy of all [drug]-related manuscripts, articles and/or posters.

A.B., 2013 Phila. Com. Pl. Lexis 84, at *28-29.  Nor did any publisher undertake to “monitor” safety (or any other) data, to “alert” anyone about safety issues, or “to report medical events and/or side effects.”  Id. at *29 (distinguishing Wawrzynek contract research organization case that we blogged about here).   In short, the publishers acted like publishers, and thus did not undertake to do anything other than publish what the manufacturers wanted.

So much for EM – the publisher alleged to have worked with the manufacturer defendant to produce materials about its drugs.

The second publisher, Elsevier, was even more remote.  It “was not in the business of providing medical communication services to the [manufacturer] or any other pharmaceutical company.”  A.B., 2013 Phila. Com. Pl. Lexis 84, at *30.  Plaintiffs could not assert liability against it merely for owning EM.  Id. at *31-33.

So there’s no duty.

There also was no causation.

Even if there could have been a duty (which there wasn’t), the publishers simply acted as publishers.  They had no relationship to the drugs themselves:

Plaintiffs argue [their] physical injury resulted from a side effect inherent in the prescription drugs.  It is undisputed [publishers] were not the manufacturers of [the drugs], and Plaintiffs do not allege [publishers] altered the chemical composition of these drugs.  As such, Plaintiffs’ allegation [publishers] failed to use reasonable care did not result in an "increased risk" of physical harm actionable under §324A(a).

A.B., 2013 Phila. Com. Pl. Lexis 84, at *34.

Nor did the publishers undertake any duty owed by the manufacturers.  “[T]he record fails to show the [manufacturer] delegated, in whole or in part, its affirmative duty to adequately warn of its prescription drugs’ associated risks.”  Id.  The manufacturer (as already discussed) retained control over what was ultimately published.  Id.

Lastly, there was no warning causation in the ordinary sense.  That is, as with any other alleged misinformation, for it to be causal, the prescribing doctor had to rely upon it.  Here the prescriber’s testimony did not established whether he did “review or rely” on the articles in question.  Id. at *35.

That killed the negligent undertaking claim, whether under Pennsylvania or Texas law.

The plaintiffs asserted fraud as a fallback.

Again the publishers acted as publishers.  Even if what they did could be considered “ghostwriting” (which lawyers do all the time) or “off-label marketing,” there was simply no evidence of intent.  Plaintiffs “lack[ed] . . . evidence to demonstrate [defendant publisher] knowingly or recklessly made any material misrepresentation concerning the risk” with respect to either the claimed ghostwriting or off-label marketing.  Id. at *39.  The purported source of fraud liability was the same "duty of care" under Restatement §324A that the court had already blown out of the water when presented directly as a negligence variant.  2013 Phila. Com. Pl. Lexis 84, at *42.  "Plaintiffs' claim for fraud, premised upon allegations of Defendants' purported silence, i.e., non-disclosure, fails as a matter of law" because that was no duty at all, as already decided.  Id. at *43.

And the reliance element, as well, killed the fraud claims.  The learned intermediary rule applies to fraud cases.

One of the essential elements for fraud is reliance, regardless of the form of relief sought.  The plaintiff must have relied upon the statement or representation as an inducement to his action or injurious change of position," and such reliance must be justifiable.  A review of the record reveals Plaintiffs' fraud claim is barred by the learned intermediary doctrine.

A.B., 2013 Phila. Com. Pl. Lexis 84, at *43 (footnotes omitted).

The Court rejects Plaintiffs’ argument the LID should not be applied to his fraud and consumer protection claims on the ground this doctrine is inapplicable to claims not sounding in negligence.

Id. at *49.

Defense counsel should pay particular attention to the next point, which involves warning causation.  The rationale goes beyond publishers – it involves who wins when the prescriber doesn’t remember.  Since the plaintiff bears the burden of proof, the defense wins.  “[P]roximate cause is not presumed.”  Id. at *47.  “A plaintiff . . . cannot establish causation if the record lacks evidence to indicate the prescribing physician reviewed or relied upon information furnished by the defendant in prescribing the drug.”  Id. at *47-48 (footnote omitted).  “Pennsylvania courts generally reject a presumption of the reliance under the 'fraud on the market' theory in the context of product liability actions.”  Id. at *58 (footnote omitted).  Just as with the §324A claim, there was no evidence that plaintiffs’ prescribers relied on anything the publishers allegedly published.  The prescriber never identified any article or any other material that he relied upon that had any link to the publisher defendants.  Id. at *54-55.  Basically, the prescriber testified that he didn’t remember.  That isn’t enough to satisfy plaintiffs’ affirmative burden of proof:

While [the prescriber’s] lack of memory does not preclude the possibility he had read materials [publisher] created, it cannot satisfy Plaintiffs' burden to prove Defendants' alleged misrepresentations and omissions were the producing cause, i.e., proximate cause, of [plaintiffs’] injury.

Id. at *55.  Further questioning that “if” articles had existed, the prescriber would have read them was “speculat[ion]” and “cannot satisfy Plaintiffs’ burden.”  Id.

Another garbage scow theory was consumer fraud, plaintiffs' second fallback.  The court applied Texas law because the plaintiff (a litigation tourist) lived in Texas at all relevant times and took the drug there – although A.B. drops a nice footnote (which as Pennsylvania lawyers, we take due note of) about how the defendants would also win under the Pennsylvania Unfair Trade Practices & Consumer Protection law.  Id. at *87-88, n. 179.  Plaintiffs cannot change the applicable consumer statutes simply by bringing their cases in Pennsylvania.  “Pennsylvania courts have refused to apply Pennsylvania substantive law where the plaintiff was injured in his home state and other qualitative contacts with the resident's state were present.”  A.B., 2013 Phila. Com. Pl. Lexis 84, at *77.  Again, the learned intermediary rule applies to consumer fraud cases (indeed, to any informational claim where a prescribing physician is present).  Id. at *80 (learned intermediary rule “applie[s] to all of the causes of action, including the [consumer fraud] claim”).  Once again the court rejected the §324A-style duty argument premised on a warning-related  “undertaking” that A.B. already rejected in the negligence and fraud contexts.  Id. at *81.

We won’t go through the causation/reliance argument (id. at *85-87) for a third time (in the consumer fraud context), since by now there’s hardly enough rubble left to bounce.  Besides, the finding that publishers owe no duty is more interesting and important:

Plaintiffs argue [the publisher] owed a duty of care as a result of their contractual obligations to the [manufacturer]. . . .  [They] never contracted with the [manufacturer] to provide services for [the drugs], and thus, there can be no finding [publisher] undertook or assumed the prescription drug manufacturer’s affirmative duty to warn [the prescribing] physician of the prescription drugs’ inherent dangers.  Absent a duty to warn, [publisher] is not liable to Plaintiffs under the [consumer fraud statute] for any alleged misrepresentation or non-disclosure.

A.B., 2013 Phila. Com. Pl. Lexis 84, at *83-84.

Finally, because neither conspiracy nor punitive damages can survive in the absence of a viable underlying tort claim, both of those allegations also fail.  Id. at *89-93

Thus, A.B., in addition to its nice causation ruling about the defense winning where the prescriber doesn’t remember, also holds definitively that publishers – and in particular publishers that had actual dealings with drug manufacturers (publishers operating entirely independently would be a fortiori) – owe no duties to plaintiffs purportedly injured by the drugs in either: (1) negligence, (2) fraud, or (3) consumer fraud, as long as they simply do what publishers usually do.  We view the no-duty rulings as particularly important because they aren’t subject to change depending on the testimony of this or that prescribing physician.  Rather, the no-duty rulings establish the lack of a viable cause of action against publishers as a matter of law.

This means that, following A.B. the result in cases such as Slater, decided under a fraudulent joinder analysis, should now be different with respect to publisher liability.  Slater was decided in a vacuum.  There was no Pennsylvania precedent either way on publisher liability.  So the court could, under the loose fraudulent joinder standard, hypothesize that there might be some “colorable” claim out there.  That vacuum has gone away.  A.B. has held affirmatively that publisher liability does not exist even as to publishers who actually contracted with drug manufacturers to publish material about their drugs.  Thus, publisher liability is no longer “colorable” and publishers are fraudulently joined, which cannot defeat underlying diversity jurisdiction in federal court.  Since federal/state forum-shopping is the only real reason for the attempted invention of publisher liability in the first place, once that proves ineffective, plaintiffs likely will cease joining publishers as defendants under what is trulyl a frivolous cause of action not recognized by any state.

Mark Marcum Down as a Not-So-Good Case on Preemption and TwIqbal

We are looking forward to this week’s DRI Drug and Medical Device Seminar and the opportunity to get together with so many old friends.   We'll learn some new things, relearn too many old things, maybe learn some wrong things, and listen to judges tell us how we should be able to work out most of our disputes with plaintiffs.  When lawyers congregate, they waste liters of vodka and oxygen bragging about their latest wins.  By contrast, plaintiff lawyers are content merely to show off the proofs of their successes, in the form of Porsches, Patek Phillippes, and pinky rings.  It is passing strange how we lawyers feel the imperative to tell war stories where we always emerge as winners.  That impulse is possibly understandable, but it is not particularly useful.  The medical profession has a much sounder practice of focusing on cases gone kablooey.  The periodic mortality and morbidity meetings at hospitals discuss errors and ways to avoid them.  Everyone says that you can learn more from defeats than victories.  But while lawyers just say it, doctors practice it.  Wouldn't it be great to see a lineup of litigation stars ruminating on "My Biggest Blunders"?  Moreover, if there was a judicial panel on that topic, it would be a must see.  The conference planners could plant that program at the end, on Friday afternoon, and the speakers for once wouldn't be drowned out by the sound of fleeing rollaboards.

 

Today we will discuss a case that did not turn out so well for the good guys. Normally in this blog we focus on defense wins.  After all, we do not relish the idea of doing the plaintiffs’ work for them.  But today we will conduct a mortality and morbidity meeting on the case of Marcum v. DePuy Orthopedics, Inc., 2013 U.S. Dist. LEXIS 62875 (S.D. Ohio May 2, 2013), and see if there is any wisdom to be gained from it.  We will not exactly be performing a dissection, but there are definitely a few grisly bits to hold up and examine.  We’re not saying there was any discernible error or fumble – no legal-doctrinal equivalent of a sponge left in the chest cavity.  But the court’s failure to consign the case to the dustbin of history was eminently predictable.

 

Marcum is not an entirely bad case. The medical device in issue was a ceramic femoral head component for hip replacement, as opposed to all those metal-on-metal devices that gave rise to so much litigation.  Because this is a product liability case, something went wrong.  The component broke four years after the plaintiff’s hip replacement surgery and there had to be a revision surgery. Consequently, the plaintiff filed an action alleging every cause of action in sight.  Those causes of action include strict liability (defective manufacturing, defective design, and nonconformance with representations), common law negligence, breach of express warranty, breach of implied warranty, and negligent misrepresentation.  None of this is surprising. Our system seems to encourage the transformation of ignorance about what really happened into allegations that everything bad happened.  It is also not surprising that the plaintiff sought punitive damages in her prayer for relief, even though there was no reason to believe that the defendant did anything particularly terrible or malicious.  Again, our system of litigation prompts allegations of the most and the worst.  When you think of it, that process evinces a scurvy view of human nature. And it's not as if it is especially logical or inevitable. But it's what we've got.
 

The defendant did the right thing and tried to clean up this mess of a complaint by cutting away unnecessary underbrush.  The initial question was the extent to which the various product liability claims were subsumed or abrogated by the Ohio Product Liability Act.  That matters, if only because if this thing goes to trial any defendant would prefer that fewer causes of action linger in front of the jury.  There is always the danger that the jury might arrive at some silly compromise that latches onto a seemingly-throw-away count.  Less is not more; less is less.  Less is good. The plaintiff did not contest that the negligence, breach of express warranty, and breach of implied warranty causes of action were abrogated by the Ohio Product Liability Act.  [So why file them?]  But the plaintiff argued that her negligent misrepresentation claim was not abrogated because it implicated a more general duty not to deceive rather than a duty to warn.  Oh, that argument.   It usually does not work.  It did not work here.  The court correctly held that however the plaintiff dressed up the misrepresentation claim, the fundamental beef was failure to warn, and that is covered by the Ohio statute.

 

At this point, the case has become a little less clunky, and that's a good thing.  But here is where the defendant might have gotten just a tad too ambitious.  There's something to be said for quitting while you're ahead.  Mind you, we know only what we read in the opinion.  It is possible that the court's discussion does not do justice to the defense arguments and is looking to make their rejection seem as inevitable as possible by making the arguments seem as weightless as possible.  For this case, we have no inside skinny.  We are helplessly dependent on the judge's account of things.



In any event, let's all agree that the allure of preemption is undeniable.  It makes claims go away completely.  No muss, no fuss.  No need to worry about bad science, bad documents, or bad experts.  So it is no marvel that the defendant sought dismissal of the case on grounds of preemption.  But the ceramic femoral head is a Class II medical device.  We lost that issue in Lohr years ago.  So it is also no marvel that the court rejected the preemption argument, even if the court garbled the law in getting there.  For instance, the court held that the plaintiff's strict liability claims "are not, at base, claims for violation of federal law."  Marcum, 2013 U.S. Dist. LEXIS 62875 at *10.   Okay.  So what?  Instead, "Plaintiff’s claims in question are that Defendant breached well-recognized state law duties owed to her through conduct that is also a violation of federal law, and these claims are therefore not preempted by Buckman."  Id.  We'll confess that we are not sure what the court means by that.  Is this an invocation of the "parallel" claim exception, even though, like we said, this isn't a PMA device?  That word nowhere appears in the decision.  Look, there probably was not going to be preemption for this 510(k) cleared product anyway, but now we have some baffling, ugly language that will be cited in cases where there might actually be a vigorous preemption claim.  We can think of arguing preemption in a case where a plaintiff is challenging the 510(k) status of a product, where the plaintiff argues that the clearance process is illegitimate, or that the manufacturer should have insisted on going the PMA route, or that the manufacturer should have engaged in testing above and beyond that required by the 510(k) clearance process.   Otherwise, don't lead with your chin, not on a defense as precious as preemption.  We'd like to think those valid preemption arguments are not foreclosed by the court's reasoning in Marcum, but we're not certain what that reasoning is or what argument by the defendant provoked such reasoning.

 
 

It looks like the defendant mounted a TwIqbal challenge to the complaint, and the court mushed together the manufacturing and design defect claims in a way that mystifies:  "Plaintiff pleads and references good manufacturing practices that Defendant is required to maintain, including establishing and maintaining quality audits, quality testing, and process validation for the Articul/EZE ceramic femoral head, and that here, in their absence, the product was defective and failed, resulting in a fracture of the ceramic femoral head and injuries."  Id. at *13.  How precisely did the defendant depart from manufacturing specs or good practices?  Dunno.  Has the Marcum court just blessed a formula that will permit every manufacturing defect claim to survive via a blizzard of empty words?  According to the Marcum court, such a blizzard is enough to blow away pleading requirements: "Specifically, Plaintiff pleads that Defendant designed, manufactured, sold, distributed and supplied the Articul/EZE ceramic femoral head into the stream of commerce, that it was defective when it left Defendant’s hands, and that it reached Plaintiff on November 12, 2007 when she underwent a left total hip replacement."  Id. at *13-14.  Check out that word "Specifically."  That is what we in the biz call a howler. 

 
 

The court also rejected the defendant's assertion that the plaintiffs claims were "inadequately pled because she does not currently have the device in question or because her surgeon's assembly of the hip implant device rendered the product substantially altered."  Id. at *14-15.  The court reasoned that the unavailability of a medical device is not fatal if there is circumstantial evidence of the alleged defect, and the alteration of the device was expected and intended and, thus, not a barrier to either design or manufacturing claims.  Id. at *15.  It is far from pellucid how any of this fits in with pleading issues, unless the idea is that the unavailability or alteration rendered the product liability claims implausible.  It just might be that the court is not telling us what the defendant actually argued. 

 
 

Similarly, we are never told exactly what the defendant's argument was against the claim for nonconformance with representations claim.  What we are told is that the plaintiff "pleads that she and/or her physician justifiably relied on Defendant’s representations about the wear characteristics of Defendant’s product in choosing the Articul/EZE ceramic femoral head.  Additionally, Plaintiff pleads that Defendant’s representations were false and the femoral head fractured inside her body. "  Id. at *17.  Again, those are rather empty allegations.  Anyone could author them, untethered to a single fact.  And what gives with the "she and/or her physician"?  Shouldn't it just be the physician?  As is so mind-numbingly often the case with these cases, it becomes enough for the plaintiff simply to say that the product failed.  There's your proof of defect.  There's your proof of a lie.  Except it isn't. 

 

Finally, the court says that the complaint adequately sets forth a request for punitive damages.  Under Ohio law, punitive damages are precluded if the device was manufactured and labeled in conformance with Food and Drug Administration regulations.  The Marcum court holds that "[a]though the fact that Defendant received marketing approval does not establish that Defendant’s product was actually manufactured and labeled in accordance with that approval, Plaintiff must allege facts to show a lack of the required compliance."  Id. at *18.  Hmmm.  So we are talking about compliance with federal law, ay?  And some jury in Ohio, as opposed to the FDA, will decide that, ay?  Getting past that, how does the plaintiff allege lack of such compliance?  Here's how:  "Plaintiff pleads that, in conflict with the requirements of the 510(k) approval process, the Articul/EZE ceramic femoral head was adulterated because the product failed to meet performance standards, that Defendant failed to establish and maintain current good manufacturing practice with respect to quality audits, quality testing, and process validation, and that as a result of Defendant’s failure to maintain such standards as required by the 510(k) approval process, the device failed and caused Plaintiff’s injuries."  Id.  Hence, according to Marcum, a few vague generalities are enough to conjure up the threat of punitive damages. 

 
 

As we said, all we can do is hold up the nasty parts of this opinion and gaze in distaste.  We recommend using tweezers and rubber gloves.

Third Circuit Calls on Preemption to Oust New Jersey Food Claims

            Last year, we blogged about the District of New Jersey’s dismissal of a putative class action involving the margarine substitute, Benecol Spread.  See here.  In celebrating the win, we focused on the defense decision to lead with standing – a less often used argument than heavy-hitters like preemption or Twiqbal.  A bench player, if you will, that came through in the clutch.  But that was regular season play.  Now we are talking about the playoffs.  And, while we are happy to report that defense win stands, the Third Circuit sent standing back to the minors and let preemption swing away.

            In Young v. Johnson & Johnson, 2013 U.S. App. LEXIS 9422 (3d Cir. May 9, 2013), plaintiff took issue with Benecol’s labeling that stated the product contained “NO TRANS FAT” and that it is “Proven to Reduce Cholesterol.”  Id. at *2.  Plaintiff claimed that those (and similar) statements were false and misleading because Benecol contains small amounts of trans fat.  He also claimed that he paid a “premium price” for Benecol relying on those statements.  Id. at *3. 

            As more fully explained in our prior post, the district court found that plaintiff had not pled a sufficient injury-in-fact (he got what he paid for and alleged no adverse health effects).  While only addressed in a footnote by the Third Circuit, it is clear that they did not agree.  The appellate court cites other decisions by the District of New Jersey which found standing under the New Jersey Consumer Fraud Act where plaintiff alleged “financial injuries based on their purchase of a product that did not have the attributes it claimed.”  Id. at *6-7, n.4.  We haven’t parsed through these other cases, we simply note that they exist and the Third Circuit apparently agreed with their reasoning instead.  The court did acknowledge that plaintiff’s standing was “tenuous,” but enough to survive a motion to dismiss.  Id.    

            But that’s what’s good about having a deep bench.  The defendant had preemption waiting in the wings to bring home the victory.  The Federal Food, Drug and Cosmetic Act (“FDCA”), as amended by the Nutrition Labeling and Education Act (“NLEA”), governs food nutritional labeling.  And the NLEA has an express preemption clause.  States can’t impose a nutritional labeling requirement “that is not identical to the requirement” imposed by the FDCA.  Id. at *4.  So, the court had to see what the FDCA had to say about trans fat and cholesterol claims.

             As to nutrition labeling about fat content, the federal regulations provide “[i]f the serving contains less than 0.5 gram [of trans fat], the content, when declared, shall be expressed as zero.”  Id. at *7.  Each serving of Benecol contains less than .5 grams of trans fat, and so Benecol’s nutrition facts correctly reported trans fat as 0 grams per serving.  But plaintiff’s issue was with labeling that the product – as a whole – contains no trans fat.  Id.  Both the court and the FDA found plaintiff’s argument splits too fine a hair:

The FDA has long recognized the potential for a discrepancy between required disclosure of "zero grams per serving" and an accurate nutrient content claim that the product is not, in fact "free" of the nutrient in question. Because "[s]uch declarations could be confusing to consumers, and this consequence is unintended[,] ... the determination of whether a product is free of a nutrient [is] based on the value of the nutrient ... per labeled serving."

Id. at *8-9.  So, because the FDCA expressly allows a nutrient content claim that a food contains “no fat” when each serving contains less than 0.5 grams per serving, plaintiff’s attempt to impose liability for making such a claim under state law is preempted.  Id. at *9-10.  The decision cites three other cases that reach the same conclusion, including Reid v. Johnson & Johnson, 2012 WL 4108114 (S.D. Cal. Sept. 18, 2012), that was discussed in a guest post here.   The court also found the “NO TRANS FAT” claim “not misleading” in accordance with the federal regulations. 

      Plaintiff’s cholesterol claims met the same fate.  Plaintiff alleged that FDA regulations allow claims that plant sterol/esters are proven to reduce cholesterol, which is different than defendant’s claims that Benecol is proven to reduce cholesterol. Young, 2013 U.S. App. LEXIS 9422 at *11. While the fat content was a nutritional claim, this is considered a health claim – and as such more expressly regulated.  “Food labeling may not include a health claim, whether express or implied, unless the claim is specifically provided for in [the regulations].”  Id.  What do the regulations provide – that products containing a certain minimum amount of plant sterol esters (such as Benecol) are “permitted to make heart health claims.” Id. at *12-14.  Since “the regulations expressly authorize [Benecol] to make the health claim,” plaintiff’s state law claims seek to impose standards that are not identical to FDCA regulations, and are therefore preempted.    

            So in summary -- preemption racks up another win, Young gets added to the list of favorable appellate-level food labeling cases, and perhaps New Jersey looks a little less inviting to plaintiffs’ counsel looking to bring these claims somewhere other than California.  It may not have been standings time to shine, but we’ll take the rest. 

Indiana’s “Government Compliance” Presumption Against Defect and Negligence

The Indiana Court of Appeals recently issued an opinion applying the section of Indiana’s Product Liability Act (IPLA) that, under certain circumstances, creates a rebuttable presumption against a finding of defect or negligence in product liability actions.  See Gresser v. Dow Chem. Co., 2013 Ind. App. LEXIS 204 (Ind. Ct. App. Apr. 30, 2013).  The case involved a termiticide (termite treatment) and the EPA, but the opinion applies equally to cases involving drugs, medical devices and the FDA. 

We’ve talked about statutory presumptions recently.  Last week, we posted on New Jersey’s statutory “super-presumption” (meaning virtually dispositive), which creates a rebuttable presumption that a warning about a drug or medical device is adequate if the warning was approved by the FDA.  As far as we know, Indiana’s presumption isn’t a “super-presumption.”  But in a number of ways it sweeps more broadly than New Jersey’s presumption.  For instance, it not only applies to drugs and medical devices, but to any product involved in a product liability action.  And if that product is regulated by the federal or Indiana government, compliance with those government regulations creates a presumption that the product is not defective and the manufacturer was not negligent – in other words, it addresses more than just failure-to-warn claims.  Here’s the statutory language:

Rebuttable presumption

Sec.1. In a product liability action, there is a rebuttable presumption that the product that caused the physical harm was not defective and that the manufacturer or seller of the product was not negligent if, before the sale by the manufacturer, the product:

. . .  

(2) complied with applicable codes, standards, regulations, or specifications established, adopted, promulgated, or approved by the United States or by Indiana, or by an agency of the United States or Indiana.

Ind. Code § 34-20-5-1.

Gresser involved the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which required Dow to register its termiticide with the EPA.  Such registration meant that the “EPA must make an official agency determination that the product does not pose any ‘unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of [its] use.’”  2013 Ind. App. LEXIS 204, at *10 (quoting FIFRA).

 And guess what?  Dow had registered the termiticide with the EPA.  Id. at *11.  It also submitted data in support of its registration that fully complied with Indiana law. Id.  And it distributed the termiticide with the current EPA-approved labeling.  Id.  Accordingly, the court concluded that Dow was “entitled to the statutory presumption.”  Id.  That presumption was against any defect claim, including both failure-to-warn and design defect.  And the court’s discussion of the policy reasons underlying the presumption would apply just as well to the FDA:

[C]ompliance with FIFRA and Indiana law has a significant impact under IPLA's consumer expectation-based product liability regime because the risk of harm has been evaluated by agencies charged with the duty of monitoring the effects of [the product]. Furthermore, [the product’s] labeling and warnings have been approved by agency experts.

Id. at *10-11.  The court, accordingly, held that Dow was entitled to judgment on plaintiffs’ failure to warn and design defect claims.  Id. at *13. 

Plaintiffs’ arguments to rebut the presumption didn’t work.  In some ways, what the plaintiffs argued hurt them.  For instance, they were also suing the contractor who applied the termiticide and alleged that “their injuries would not have occurred absent the contractor’s negligence.”  Id. at *12.  Well, that position seemed to undercut their claim that a defect in the product caused their injuries, something that wasn’t lost on the court.  Id.  Similarly, plaintiffs’ argued that Dow entered into settlements with the EPA and, as part of that, strengthened the product’s warnings.  True, it seems, but that all happened before the termiticide was used on their property.  The court also found that this argument, once again, undermined plaintiffs’ claims.  Id.

So there seem to be a lot of possibilities with this “government compliance” presumption in Indiana.  It may be quite useful, particularly at the summary judgment stage, in drug and device cases in which plaintiffs have little to no evidence that the defendant hadn’t complied with FDA regulations, and in which the defendant was using FDA-approved labeling.

Interesting Consumer Protection Twist

Every now and then we come across something new and interesting that, frankly, we hadn’t thought of ourselves.  That’s how we felt when we read the recent opinion in Boudreaux v. Corium International, Inc., C.A. No. :12-cv-2644-M, slip op. (N.D. Tex. May 7, 2013).   We mentioned the same sort of thing a few years ago in connection with a case from Tennessee that was won on the "useful life" language of that states’ statute of repose. We stated that the case "shows the need to pay close attention to, and do meticulous research into, local state law."

Boudreaux is another example – and once again, some sharp-eyed associate out there deserves a gold star (and a bonus).

Boudreaux involves a fentanyl patch, which is used for pain relief. There have been a number of prior cases – some egregious – where plaintiffs have alleged that such patches malfunctioned and led to fatal overdoses.   Boudreaux is another such case.

And therein lies the rub.

Among the claims that the decedent’s representatives made was a consumer fraud claim under the Texas statute (known as the "DTPA"). We’re not sure why that claim was made, since we’re under the impression that the DTPA, after being misused by plaintiffs in product liability litigation (and elsewhere), for quite a while, was amended a few years back to ban recoveries based on personal injury.   But be that as it may, the DTPA claim was brought in Boudreaux.

The defendant argued, and the court in Boudreaux agreed, that the DTPA claim failed because – get this – claims under this statute do not survive the death of the consumer.

Consumer fraud claims?  Abatement on death?   We haven’t heard that one before.

But apparently it’s a topic that has some currency in the Lone Star State.   According to Boudreaux, "[t]he Texas Supreme Court has not provided definitive guidance on this issue, and Texas appellate courts are split" 3-2 in favor of abatement.  Slip op. at 3 (collecting cases).   Boudreaux went with the majority on this issue and dismissed the DTPA claim. Here’s the reasoning:

The DTPA "does not explicitly provide for the survivability of a consumer’s cause of action."  Slip op. at 4.


Where a statute is silent, under the common law "actions primarily affecting property and property rights survived the death of the aggrieved party whereas actions asserting purely personal rights did not."   Id.



Because they are "punitive" a claim for exemplary damages is considered a "personal right" and does not survive death.   Id.



The DTPA, since it provides for treble damages, is also punitive in nature.   Id.



Claims which the law does not allow to be assigned to third parties are also personal in nature.   Id. at 4-5.


Under Texas law, DTPA claims may not be assigned.   Id. at 5.


Therefore, DTPA claims are personal in nature and thus abate upon the death of the aggrieved consumer.   Id. at 5.

Bingo. Because the person who used the fentanyl patch in Boudreaux had died, therefore the claim had abated and could not be brought:

This Court is of the opinion that the Texas Supreme Court, if faced with this issue, would find that a consumer’s cause of action under the DTPA does not survive the death of the consumer and cannot be brought by a representative of the consumer’s estate, in a representative capacity or in an individual capacity, based on the consumer status of the decedent.

Boudreaux, slip op. at 5.   Motion to dismiss granted.

Here’s the larger point.  None of us on the blog are Texas lawyers, and we thus we would not have known even to look for this article on our own.  Listen to your local counsel – that’s what you hired them for.   Also, when you’re unfamiliar with a state’s law, let a bright associate do some poking around.   That’s what you hired them for.

Here’s the even larger point.  We also don’t know whether other states follow the same logic as the Texas courts do with the DTPA.   Perhaps other states’ consumer fraud statutes speak explicitly to survivability (although we suspect that’s rare).   Perhaps other states’ statutes don’t include a "punitive" treble damages provision (although we think most do). Perhaps other states allow assignment of consumer fraud statutory causes of action (we have no gut reaction to that).   What we’re trying to say is that Boudreaux suggests that in any case where the product user is deceased, if there’s a consumer fraud claim pleaded, it would be a good idea to see if abatement is a viable defense.  If it is, then it’s a home run on that claim.

One more thing to look at – one more defense to plead in appropriate cases.

 

Big Sky Beat Down

            We read rulings under the Federal Tort Claim Act about as often as we read bench trial rulings or rulings from the District of Montana.  Or rulings where a judge says he is retiring in two days.  That is, with a frequency somewhat below what our diminishing memory can recall.  In Holtshouser v. United States, No. 11-114-BLG-RFC, 2013 U.S. Dist. LEXIS 62607 (D. Mont. May 1, 2013), we satisfied all four of these rare (for us) criteria.

            In some ways, though, the case was very familiar.  The plaintiff claimed to have developed tardive dyskinesia and aggravation of Parkinson’s Disease symptoms from use of generic metoclopramide for severe GERD and diabetic gastroparesis on and off for several years; the branded from of metoclopramide is known as Reglan and we have discussed a few decisions on cases involving branded and/or generic metoclopramide over the years.  Also familiar was that the plaintiff, a 91 year old Navy veteran, was what is known affectionately as a “train wreck,” with at least 15 different chronic medical conditions, at least 20 different medications a day, and frequent visits with a variety of health care providers during the period of use and injury at issue in the case.  (We say plaintiff, but Mrs. Holtshouser sued, presumably for loss of consortium—an aggressive position under the circumstances.)  He seemed to have a significant need for the metoclopramide, having failed on other therapies, and the metoclopramide seemed effective when he was on it.  It also looks like the patient and all the prescribers had their eyes open about the risks of the metoclopramide, particularly when using it beyond the periods identified in the label.  In our jaundiced eyes, while these facts suggest no good claim against the branded or generic manufacturer, we expect one or both of them would get sued.  Nope.  The suit was only against the U.S., based only on the alleged negligence of the pharmacy at the Veteran’s Administration that dispensed the metoclopramide to plaintiff.  None of the VA or private prescribers were sued for negligence.  Just the pharmacy.

            The choice here is what interests us.  We have ranted a few times about the misguided expectation of many lawyers and some courts that a person injured by the use of a medication should always have someone from whom to recover.  We assume that, before filing the complaint on September 30, 2011, plaintiff’s counsel mulled over which potential defendant(s) to sue, the best theory to urge, where to sue, and such.  We assume that plaintiff’s counsel noted that the Supreme Court decided Mensing on June 23, 2011, and shut down the chance of a suit against the (generic) manufacturer of the drug the plaintiff actually took.  We suspect that plaintiff’s counsel read the wind on Conte innovator liability—maybe from some snarky blog—and figured Montana would not endorse liability against the branded manufacturer.  (We do not think Montana courts or courts guessing at what Montana courts would do have chimed in yet.)  We wonder if plaintiff’s counsel read through the lousy Montana Supreme Court in Stevens v. Novartis and saw that the learned intermediary doctrine was followed in Montana, thought about the rejection of the heeding presumption in Riley v. American Honda Motor Co., 856 P.2d 196 (Mont. 1993), and/or found the prescribers would not support any failure to warn.  Based on the suit that was brought, we have to assume that whatever analysis happened pre-suit determined that suing the deep pocket manufacturers was a dead end or not worth it.

            When smart zoos build new enclosures and want to ensure that the planned inhabitants cannot escape, they try out the enclosures with orangutans.  Our forest cousins have the combination of brains, agility, strength, curiosity, and a desire to get out that puts wannabe Houdinis to shame.  We would not compare plaintiff lawyers to orangutans—we like orangutans and hope they prosper in their natural habitat—but the plaintiff lawyers do have a way of coming up with someone to sue and something to say they did wrong, regardless of the legal walls or factual moats they have to traverse.  We cannot say that the decision in Holtshouser represents any kind of trend of how plaintiffs who took generic drugs will try to proceed post-Mensing in a venue that has not followed the Conte nonsense.  First, pharmacy liability is generally not an easy route on the typical facts.  Most jurisdiction, as detailed in this post, reject it.  In Montana, pharmacies have to pass on manufacturer warnings and only have to do more (like warn the patient or contact the prescriber) if they know something about the patient that puts him at extra risk with the medication prescribed.  2013 U.S. Dist. LEXIS 62607, **26-27.  Second, when it comes to government pharmacies—which do dispense a big chunk of the prescription drugs in the U.S.—proceeding under the FTCA involves three aspects that plaintiffs tend not to like:  (1) pre-suit administrative requirements, (2) bench trials only, and (3) no punitive damages.  Other than the money saved with a three day bench trial compared to a longer jury trial, we have a hard time seeing what was appealing to plaintiff and his lawyer about bringing this suit.

            We do not really have to understand why it was brought, though.  We can just sit back and read the Court’s numbered and logically organized findings of fact and conclusions of law.  The result, you may have guessed by now, was fairly predictable – the plaintiff lost because he could not establish any breach by the VA.  The opinion provides a new angle on familiar topics of prescription drug labeling, labeling changes, off-label use and dueling experts.  The court found that doctors rely on medical literature rather than the label for information on the drug’s risks and uses.  Id. at *21.  It also found that most drugs are prescribed off-label, including for longer that the duration specified in the label.  Id.  The U.S. offered an expert who testified that “a manufacturer’s label is not proscriptive, and does not prohibit use for a longer period, or in any other manner not described in the labeling” and “a licensed prescriber can prescribe [an approved] drug for any use either within or outside of the label, if doing so, in the opinion of the prescriber, is in the best interests of the patient.”  Id. at **21-22.  We note that this is not exactly the position the U.S. takes in False Claims Act cases.  The expert the plaintiff offered in response did not know the standard of care for pharmacists in Montana, but contended that that the VA’s “integrated system” with a centralized dispensary in Kansas brought along some sort of heightened standard of care.  Id. at **22-23.  This sounds much like standard of care testimony offered against drug manufacturers, but this court saw through the testimony as just “her personal standard of care that had no concept of the reality of operation of the VA system in Montana.”  Id. at *23.  It is nice when reality is part of the standard of care.  Some plaintiff experts can be so divorced from reality that they even write their own (lousy, trashy) fiction in their spare time.  The apparent advantage of the bench trial is that the judge can listen to the expert’s whole spiel as the fact finder before deciding to give it no weight.  We would like to see more judges exercise their gatekeeper function up front and protect juries from hearing an expert’s mere “personal standard of care.”

            Because that was all that the plaintiff offered in Holtshouser, and because he had no evidence that the pharmacy actually did know something about him that made him uniquely susceptible to the risks of metoclopramide, he lost.  We will not decry the waste of tax dollars in defending this suit.  Plaintiff got his day, or rather three days, in court.  It happened to be before a judge who got it before he rode off into the sunset.  We are sure that the next potential plaintiff facing the same hurdles as Holtshouser faced pre-suit will not be sufficiently deterred to do the novel thing and not sue anybody.  Deciding to sit still can be difficult even if you are stuck.