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.