Another Aredia-Zometa Win, Read Against That Institute You Can't Disparage

Marriage is a civil institution, so it's natural that there are so many laws respecting it. Marriage is also an emotional, fragile relationship, so it's also natural that many of the laws are a bit nutty.   For instance,  on Sundays in Hartford, Connecticut, it is illegal for a man to kiss his wife.  A married couple in a rented room in Massachusetts may not legally sleep in the nude.  In Vermont, a wife must have written permission from her husband to wear false dentures.  And marriage-law-madness is not confined to New England.  You might have heard of proxy weddings, where the marriage ceremony takes place without the presence of either the groom or the bride -- somebody else stands in for one of them.  There might be perfectly good reasons for that to happen.  But in Montana (and, as far as we can tell, only in Montana) there can be a proxy for both the groom and the bride.   We do not know whether the Big Sky state also countenances proxy honeymoons.  In Kentucky, a woman is not allowed to marry the same man more than 3 times.  Hmmm.  Maybe that’s not so strange.  Maybe that’s just common sense.

We’ve all likely heard the phrase that the “law is an ass.”  It comes from the Charles Dickens novel Oliver Twist, when a character is schooled on the fine points of the doctrine of coverture.  Specifically, Mr. Bumble is informed that “the law supposes that your wife acts under your direction”.  Mr. Bumble replies “If the law supposes that … the law is a ass – a idiot.  If that’s the eye of the law, the law is a bachelor; and the worst I wish the law is that his eye may be opened by experience.” 

Joe Hollingsworth recently sent us another defense win in the Aredia-Zometa litigation, and there are a number of aspects to it that will cheer and empower other defense practitioners.  But the case also reminded us of the way marriage sometimes sits rather oddly in the legal matrix.   In Wheeler v. Novartis Pharmaceuticals Corp., Case No. 1:11-cv-0021 (S.D. Ga. May 15, 2013), a husband brought suit both on behalf of the estate of his deceased wife and in his personal capacity for loss of consortium.  The claim was that his wife developed osteonecrosis of the jaw (“ONJ”) as a result of her use of Zometa.  The court granted summary judgment for the defendant on the claims of both the estate and the husband, but for different reasons.

The court had no problem holding that the underlying claim on behalf of the wife’s estate was barred by Georgia’s statute of limitations for personal injury actions.  Georgia law requires that “[a]ctions for injuries to the person shall be brought within two years after the right of action accrues…”O.C.G.A. §9-3-33.  The lawsuit was filed on December 28, 2011.  The court gave the plaintiff the benefit of the doubt by treating the prescription of the drug as a continuing tort (there were continual doses of Zometa), thus permitting the plaintiff to invoke the discovery rule.  But even the discovery rule could not save the underlying claims.

The wife arguably discovered her injury as early as July 14, 2009, when she underwent the extraction and grafting procedure of her jaw.  Less than a week after that extraction, her doctor told her that Zometa was a potential cause of her jaw injuries.  On October 8, 2009, another doctor told the wife that “she had evidence of osteonecrosis of the jaw and that continuing the Zometa would worsen the condition.”  Consequently, the wife knew the cause of her ONJ on or before October 8, 2009 at the latest.  That was more than two years before she filed suit, so the claims based upon her personal injury were untimely and barred by the statute of limitations.  On July 10, 2010, the wife passed away due to her metastatic breast cancer.

The husband’s loss of consortium claim was a different matter.  We usually think of a loss of consortium claim as being completely derivative of the underlying claim.  But the Wheeler court held that “[t]he running of limitation for a personal injury claim does not bar a derivative loss of consortium claim.”  The statute of limitations for a claim of loss of consortium is four years, and thus the husband’s loss of consortium claim was filed well within the limitation period. 

Thus we are presented with a case where the injured party might be out of court but the spouse could proceed with the loss of consortium claim.  Still, the court granted summary judgment on the loss of consortium claim as well, because all of the underlying claims failed on the merits.  First, there was “no probative evidence” to establish causation.  The plaintiff failed to designate any expert witness to opine on causation.  Slip Op. at 14-15.  The learned intermediary doctrine barred the failure-to-warn claim because the wife’s prescribing oncologist testified that he was aware of the risks associated with Zometa at the time he prescribed it, that such risks were well known in the medical community, and most significantly, that he continues to prescribe Zometa in the same manner today as he did for the wife.  Slip Op. at 16-18.  Finally, the warranty claim failed due to a lack of privity, as there was no evidence that the drug was purchased directly from the defendant.   

Maybe there are sound reasons why loss of consortium actions should enjoy a longer limitations period than the underlying action.  Maybe the theory is that the spouse is less in a position to know when an action accrues.  Here, the wife had died, so maybe there is some sense in giving the surviving spouse more time to figure out that there is a lawsuit.  But the rule would seem to apply whether or not the primarily injured party was alive or not, and one could envision a very odd case where the injured party would be reduced to being a spectator to the loss of consortium claim.  It would be just another case of marriage and the law making strange bedfellows.   

Plaintiff’s Second Try Still Preempted

            We talk about a lot of motions to dismiss on this blog and being a defense blog, the overwhelming majority are successful.  Motions to dismiss being what they are – motions that examine only the pleadings and are generally brought early on in the life of a lawsuit – a fair number of the motions we bring to your attention are granted without prejudice.  In other words, courts frequently give plaintiffs another chance – a second bite at the apple.  And so many of our posts on these cases end with a caveat that the case could be resurrected or a prediction that plaintiff’s amended complaint will meet the same demise.  We also usually tell you we’ll report back with further developments. 

            Well, so you know we aren’t making hollow promises, we have just such an update today.  Back in October, we told you about McClelland v. Medtronic, Inc., (M.D. Fla. Sep. 27, 2012) (see post) in which the court dismissed plaintiff’s claims -- negligence per se and failure to warn -- arising from the implantation of a pacemaker on the grounds of no private right of action to enforce the FDCA and preemption.  Relying on   In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010), the McClelland court granted plaintiff leave to file an amended complaint, noting that “a narrow gap exists for a plaintiff’s state law claim if it is to avoid express or implied preemption....”  Slip op. at 13. 

            Last week, the court found that plaintiff’s amended allegations failed to fit in that “narrow gap.”  The claim that was previously dismissed was premised on defendant’s failure to report certain adverse events to the FDA.  Plaintiff’s amended complaint isn’t all that different:  “Plaintiff alleges that Defendant ‘fail[ed] to promptly and accurately report to the FDA incidents and problems with the [pacemaker] that occurred after the device received [PMA]’” in violation of FDA regulations.  McClelland v. Medtronic, Inc.__ F.Supp.2d __, 2013 WL 2109965, at *4 (M.D. Fla. May 16, 2013).  So, it isn’t surprising that the court this time found that to the extent plaintiff was alleging a breach of duty owed by defendant to the FDA, the claim was implied preempted pursuant to Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  McClelland, 2103 WL 2109965, *6.   The claim also failed because no private right of action exists under the FDCA.   Plaintiff cannot “recast a claim for violation of the FDCA as a state-law negligence claim” because “the United States rather than private litigants are authorized to file suit for noncompliance with the medical device provisions.”  Id. (quotation marks and citations omitted).

            But plaintiff also claimed that by alleging a duty to notify the FDA, she was actually contending that defendant breached a duty owed to plaintiff.  Plaintiff argued that

the essence of [her] claim is not that the defendant breached a duty to the FDA, but that it breached a duty to [the Decedent], who was in the foreseeable zone of risk created by [Defendant] – namely the duty to provide an adequate warning of the dangers of its product, which in this case paralleled its duty to comply with the conditions of its PMA.

 

Id. at *4.   Ah, the magic word “parallel.”   For plaintiff’s state law claims to parallel federal regulations, and thereby arguably fit in that “narrow gap” of claims that are not preempted, they must not impose any requirement different from or in addition to FDA requirements.  Id. at *5.  And while there is a comprehensive set of regulations governing a manufacturer’s duty to report adverse events to the FDA, “[p]laintiff has not pointed to any statute or regulation which imposes a duty on the manufacturer to inform patients about such incidents.”  Id.  So, the court quoted from its first decision dismissing plaintiff’s claims.  We quoted it in our prior post, but like the court, we think it’s worth a second mention:

Under Plaintiff’s theory of liability, Defendant would be required to provide information to ... patients beyond those on the device’s labeling. Accordingly, the state and federal requirements are not “genuinely equivalent” because Defendant could be held liable under the state law without having violated the federal law.

Id.  For the second time, plaintiff’s claims were held to be both expressly and impliedly preempted.  And this time, the court said two tries was enough.  So unless plaintiff appeals, we can now close the book on McClelland; satisfied that the story ended as well as it began.   

Plaintiffs Discover Risks of Refusing to Participate in Predictive Coding Discovery

 Let’s see whether it works: Discovery!  Are you excited?  How about this: Technology Assisted Review!!  Nothing yet?  How about: Predictive Coding!!!  We gave you three exclamation points for that one.  Are you pumped yet?

Yeah, neither are we.  But we're going to discuss these things anyway, in particular the way in which the court addressed them in a recent MDL decision in the hip implant litigation.  In re Biomet M2A Magnum Hip Implant Prods. Liab. Litig., 2013 WL 1729682 (N.D. Ind. Apr. 18, 2013).  Why?  Because it’s important for anyone whose practice involves discovery of massive amounts of electronically stored information (ESI) – and mass torts certainly qualify – to understand the potential cost savings for clients presented by technology assisted searches and the legal viability of implementing them. 

We’ve blogged about predictive coding before.  Look here.  In short, predictive coding software “learns” from the user’s selections or preferences and identifies – with greater accuracy as it learns – what the user wants to find.  It’s used for many things on the Internet, and it’s now being used to identify electronic documents for production in litigation.  The process involves an initial interaction between the software and reviewing attorneys, but at some point the software should be able to take it from there alone (for the most part).  Here’s how the MDL court described the process that Biomet used to conduct it review of the 2.5 million documents it selected for review:

Under predictive coding, the software “learns” a user’s preferences or goals; as it learns, the software identifies with greater accuracy just which items the user wants, whether it be a song, a product, or a search topic.  Biomet used a predictive coding service called Axelerate and eight contract attorneys to review a sampling of the 2 .5 million documents.  After one round of “find more like this” interaction between the attorneys and the software, the contract attorneys (together with other software recommended by Biomet’s e-discovery vendor) reviewed documents for relevancy, confidentiality, and privilege.

Id. at *1.  While it can reduce costs, things still aren’t cheap.  The review cost Biomet $1.07 million, and Biomet projected that its ultimate costs would total $3.25 million.  But a manual attorney review would have cost much more, and what plaintiffs were asking the court to order Biomet to do would have cost millions more.

You see, Biomet got to the 2.5 million documents by culling a total universe of 19.5 million documents using keyword searches and de-duplication.  Id.  Only then did Biomet apply predictive coding to search the 2.5 million documents.  Plaintiffs, however, claimed that keyword searching wasn’t accurate enough and wanted Biomet to use predictive coding on the entire universe of 19.5 million documents.  

They may or may not have had a point, but here’s where the plaintiffs found themselves in trouble with the court.  Biomet had asked plaintiffs’ steering committee to suggest additional keywords to use in the search of the 19.5 million documents and even to review the (non-privileged) documents that the  predictive coding search did not select from the 2.5 million documents – so that plaintiffs could assess the process.  Plaintiff refused both offers.  Why?  Well, plaintiffs believed that both these efforts, even with their participation, would not “assure proper document production.”  Id.  They believed that Biomet should have used predictive coding on all 19.5 million documents and that, regardless, Biomet should have waited until the MDL was formed and addressed discovery before reviewing and producing documents.  Id. 

So plaintiffs asked the court to order Biomet to start over and review the 19.5 million documents using predictive coding.  That’s where plaintiff’s lost the court. 

The court didn’t see the issue as one of whether predictive coding was a better review method than keyword searching.  The court was faced with the question of whether Biomet’s process met FRCP 26(b)(2)(C)’s proportionality test (burden and expense versus benefit) and whether Biomet should be required to start over and spend millions of dollars to do so.  The court came out on Biomet’s side: 

The issue before me today isn’t whether predictive coding is a better way of doing things than keyword searching prior to predictive coding.  I must decide whether Biomet’s procedure satisfies its discovery obligations and, if so, whether it must also do what the Steering Committee seeks. What Biomet has done complies fully with the requirements of Federal Rules of Civil Procedure 26(b) and 34(b)(2).

Id. at *2. 

Plaintiffs’ had a number of arguments on why they should have won.  While Biomet ran confidence tests suggesting that “a comparatively modest number of documents would be found” if it redid things using a predictive coding search on the 19.5 million documents, plaintiffs argued that keyword searches using Boolean methods generally identify less than 25% of relevant documents.  But the court found nothing in the record to equate the keyword searches done by Biomet to the type of Boolean search that plaintiffs used as the basis for their argument.  Id.  And the court was in no way sympathetic to the steering committee’s argument that Biomet should have waited to start its review until after the MDL was formed and addressed discovery.  Biomet had discovery obligations in the original district courts, and it was required to meet them:

It might be that the Steering Committee’s argument could carry the day in some cases, but this one doesn’t seem to be such a case.  The Steering Committee hasn’t argued (and I assume it can’t argue) that Biomet had no disclosure or document identification obligation in any of the cases that were awaiting a ruling on (or even the filing of) the centralization petition.  Until the MDL Panel enters a centralization order under 28 U.S.C. § 1407 (or transfers a tag along pursuant to an earlier centralization order), a transferee court is free to act on pending matters.  Indeed, through its conditional transfer orders, the Panel regularly encourages transferee courts to do so.  To hold that a party that behaves as the transferee court directs, or that follows the transferee court’s standing procedures, does so only by forfeiture of the proportionality provision of Rule 26(b)(2)(C), seems an uncongenial exercise of whatever discretion I have.  It also would seem inconsistent with the purposes of centralization under § 1407.

Id. at *3.

There can be little doubt that choosing to sit idly by while Biomet spent over a million reviewing documents hurt plaintiffs’ chances.  Under those circumstances, the court found ordering Biomet to redo its review to the tune of even more millions of dollars didn’t fit within FRCP 26(b)(2)(c)’s proportionality standard:

It might well be that predictive coding, instead of a keyword search, at Stage Two of the process would unearth additional relevant documents.  But it would cost Biomet a million, or millions, of dollars to test the Steering Committee’s theory that predictive coding would produce a significantly greater number of relevant documents.  Even in light of the needs of the hundreds of plaintiffs in this case, the very large amount in controversy, the parties’ resources, the importance of the issues at stake, and the importance of this discovery in resolving the issues, I can’t find that the likely benefits of the discovery proposed by the Steering Committee equals or outweighs its additional burden on, and additional expense to, Biomet.  Fed. R. Civ. P. 26(b)(2)(C).

Id. at *2.

Now, the plaintiffs’ steering committee will no doubt have more opportunities to address Biomet’s document review methods as the litigation moves forward.  But their decision to refuse Biomet’s invitation to participate from the start lost them an opportunity to have input into the original culling of the 19.5 million documents.  Plaintiffs may see a lesson in this: participate.

And we doubt that this will bring about a “be careful what you wish for” scenario.  Sure, plaintiffs’ participation in establishing the process for technology assisted review will be challenging, particularly as their approaches become more sophisticated.  But it’s necessary.  Courts have already started to signal that they want plaintiffs to participate, or at least be invited to participate.  If, in the meantime, we can move the battle from whether to use technology assisted research and predictive coding to negotiations on how they should be used, that’s a victory. 

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.