Thursday, May 16, 2013

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.

1 comment:

Amber said...

This is cool!