Thursday, July 18, 2013

Revisiting Publisher (Non)Liability

We were perusing the recent GAO report on electronic drug labeling in our spare time (we’re weird like that).  We found a number of interesting points − such as what the FDA apparently told the GAO about its position on off-label promotion (“[a]ccording to FDA, if a drug manufacturer promotes a drug for off-label uses, such promotion may constitute evidence to support a violation of the [FDCA]”) (emphasis added).  But the most interesting aspect of the GAO study for some of us was its description of the non-labeling information available to purchasers of prescription drugs, mostly through pharmacies:

Patients can receive written drug information provided along with their prescription drugs in the form of CMI [“consumer medication information”].  Unlike prescribing information, Medication Guides, and [patient package inserts], CMI is not approved by FDA, and drug manufacturers do not produce this type of drug labeling.  Instead, it is produced by third parties and distributed to patients at the pharmacy when their drugs are dispensed.  CMI can include information from the prescribing information and can also include additional information not contained in FDA-approved labeling, such as off-label uses of certain drugs.  According to officials from third parties that produce CMI, they also use other sources, such as peer-reviewed literature, to develop the information for their CMI.  FDA has not asserted the authority to require third parties to submit CMI for review by the agency before CMI is distributed, according to agency officials.

GAO Report at 7.

This discussion started us thinking again about the novel – and we would add, reprehensible – assertion of product liability claims against some of the “third parties” mentioned in the GAO’s reports.  We discussed our overwhelmingly negative reaction to so-called “publisher liability” claims back in 2011.  Then, we pointed out that this sort of claim is almost always asserted by plaintiffs for ulterior motives (chiefly joining a non-diverse defendant to prevent removal to federal court), and that no state in the country has affirmatively permitted such a claim.

Nonetheless, a scattering of federal courts (mostly in Pennsylvania and Kentucky), applying an “anything plaintiffs can think of is OK” standard for fraudulent joinder, have allowed such claims to defeat diversity (and thus encouraged their proliferation).  This is, of course, a perversion of the universally accepted (but unfortunately frequently ignored by pro-plaintiff judges) Erie rule that predictions of state law by federal judges may not entertain novel causes of action.  Unfortunately the lightening of some federal court dockets occasionally seems to trump federalism.

Then, earlier this year, we reported on a substantive decision in the Philadelphia Court of Common Pleas – that notorious pro-defense (tongue firmly implanted in cheek) hotbed – rejecting a publisher liability claim on its merits.  The main theory that the plaintiffs were able to come up with involved that last-refuge-of-a-scoundrel Restatement section, §324A “Good Samaritan” liability, that would have:  (1) required publishers to investigate the substantive validity of everything they publish (the Philadelphia case involved clinical trials), and (2) would have placed anyone who published anything about a drug, no matter how limited, under a duty to research and publish everything.  Thankfully, even in Philadelphia, that was too much for a court to stomach.

So we’ve decided once again to look broadly at the question of publisher liability.

The first question, of course, is whether what we said two years ago – that no court anywhere has ever recognized such liability – is still accurate.

Turns out it is.

First of all, that one Philadelphia case has grown to four.  Kreves v. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 3480286 (Pa. C.P. June 19, 2013); S.B. v. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 3286808 (Pa. C.P. June 12, 2013); A.B. vs. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 2917651 (Pa. C.P. April 5, 2013); and Banks v. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 2321107 (Pa. C.P. April 5, 2013).  Whether these plaintiffs have used a fraudulent joinder strategy exploiting claims against publishers to defeat diversity, or whether there are other non-diverse defendants, we don’t know.  All we can say is that we haven’t seen any removal/remand decisions in Pennsylvania federal court involving these particular allegations.

Why so many Philadelphia opinions all of a sudden?  That’s easier.  The same allegations were made and challenged in several separate cases, and they are now all going on appeal at the same time.  Under Pennsylvania rules, until an appeal is filed, a judge isn’t obligated to write an opinion.  However, since the four opinions are essentially identical, and we’ve already discussed the first of them  in some detail, we won’t rehash them here.

We have now found appellate authority rejecting claims that would hold a publisher liable to a plaintiff injured by a product that the publisher simply printed information about – and perhaps not surprisingly, it’s in a drug case:

Plaintiffs failed to demonstrate defendant [publisher] owed them any duty.  Defendant is neither the manufacturer of [the drug], which had the duty to publish the patient medication guide . . . in the language and form required by the FDA . . ., nor the pharmacy dispensing it.  Plaintiffs did not show defendant was obligated to provide any information to them at all.

Rivera v. First DataBank, Inc., 115 Cal. Rptr. 3d 1, 8-9 (Cal. App. 2010).  Rivera involved “prescription drug monographs” of the sort described in the GAO report. 

Rivera held that none of the information in question was a substitute for the FDA-approved information that drug manufacturers were required to provide with their products:

Plaintiffs’ criticism that [relevant] warnings were buried in fine print does not equate to negligence on defendant’s part.  Plaintiffs have not shown defendant had a duty to present the information in the monograph in any particular format or order . . ., the monograph is not government regulated.  And again, the monograph was not a substitute for the patient medication guide.  That [a pharmacist] failed to include that guide or the package insert or that plaintiffs overlooked them does not impose any duty on defendant to change the style, format, or contents of its monograph.  As defendant points out, plaintiffs have not presented any evidence the monograph contained any information that was false.

Id. at 9.  Accord Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1110 (9th Cir. 2003) (finding no chance of success of state-law claim against publisher of the Diagnostic and Statistical Manual of Mental Disorders); Hardin v. Palo Alto Medical Foundation, Inc., 2012 WL 8261196, at *2-3 (Cal. Super. July 3, 2012) (following Rivera and extending result to product liability allegations; rejecting theory “that having undertaken the task of providing information concerning potentially life-threatening risks, [a publisher] was obligated to do so in a non-negligent manner”).  In short, there’s no duty in California for a publisher to publish anything more about a prescription medical product than it actually undertook to publish.

A similar result was reached in Cheatham v. Teva Pharmaceuticals, 726 F. Supp.2d 1021 (E.D. Ark. 2010), another drug monograph publisher case.  The publisher’s admittedly incomplete discussion of drug risks violated no duty owed to the ultimate consumer, particularly since the same jurisdiction (Arkansas) had already rejected imposition of liability on the pharmacist that distributed the monograph:

[T]here is no basis for concluding that the monograph was intended to supplant either [plaintiff’s] physician’s warnings regarding the prescribed medication or the pharmacist’s duties in connection with filling the prescription.  [The publisher] did not deal directly with plaintiff, but provided educational materials to [the pharmacist] to permit it to comply with its Pharmacy Board mandated patient counseling requirements.  It would be contrary to existing legal principles to impose upon [the publisher] a duty greater than the pharmacy that filled the prescription and provided the monograph.

Id. at 1024.

Cheatam thus points out another problem with publisher liability.  “Arkansas recognizes the “learned intermediary doctrine.”  Id. (citation omitted).  Under this rule, actionable drug warnings go through the prescribing physician.  Id. (“a drug manufacturer may rely on the physician to warn the patient”).  Ordinarily, a pharmacist can’t be sued for failure to warn when all it did was accurately fill a prescription.  Id.  Imposing a duty on a publisher where the pharmacist can’t be sued for distributing whatever was published is even a “greater” stretch.  Id.  As we discussed previously , the learned intermediary rule also figured in the Philadelphia decisions.

A number of other courts have disposed of publisher liability claims of one sort or another on the merits in the context of litigation over prescription medical products.  New York has the longest history.  Way back in 1977, a plaintiff unsuccessfully sued the publisher of the Merck Manual.  The court found “no support” for imposing a negligence duty on an independent publisher concerning drugs its materials described but that it did not sell.  A publisher’s “reasonable anticipation that [its] statement will be communicated to others whose identity is unknown . . . or even knowledge that the recipient intends to make some commercial use of it in dealing with unspecified third parties, is not sufficient to create a duty of care.”  Development Corp. v. Merck & Co., 432 F. Supp. 990, 993 (E.D.N.Y. 1977).  Another early plaintiff unsuccessfully sued the publisher of the Physician’s Desk Reference.  See Libertelli v. Hoffman-La Roche, Inc., 1981 U.S. Dist. Lexis 11049, at *5-7 (S.D.N.Y. Feb. 23, 1981) (publisher under no obligation “to perform independent tests” or otherwise go beyond FDA-approved labeling).  In Roman v. City of New York, 442 N.Y.S.2d 945, 947-48 (N.Y. Sup. 1981), the publisher of an informative pamphlet distributed at a hospital could not be liable for an allegedly failed medical procedure.  “One who publishes a text cannot be said to assume liability for all ‘misstatements,’ said or unsaid, to a potentially unlimited public for a potentially unlimited period.”  Id. at 948.  Similarly, a printer is not liable for the content of what it prints. 
Blackburn v. Johnson Chemical Co., 490 N.Y.S.2d 452, 455 (N.Y. Sup. 1985) (printer not liable for defects in contents of product labels it printed).
Other states rejecting publisher liability include:

Colorado:  Bailey v. Huggins Diagnostic & Rehabilitation Center, Inc., 952 P.2d 768, 772-73 (Colo. App. 1997) (publisher of book on dental procedures “owed no duty of due care” to plaintiff claiming injured from dental device; “even if it be assumed that some harm might have been foreseeable, we conclude that the social utility of encouraging authors to address issues of public concern, and the magnitude of the burden that would be imposed upon them if a duty of care were recognized, far outweigh the private interest of any individual reader”).

Maryland:  Jones v. J.B. Lippincott Co., 694 F. Supp. 1216, 1217 (D. Md. 1988) (publisher of medical textbook “has no duty of care to plaintiff with respect to the content of the book and makes no warranty as to the contents”).

New Jersey:  Wilkow v. Drug Fair, Inc., 1999 WL 33645139 (N.J. Super. L.D. Oct. 22, 1999) (monograph case; “I frankly cannot find a duty between [the publisher] and the Plaintiff in this particular case.  I see no, no relationship that would . . . create a duty”).  Note:  this is a transcript of an oral hearing.

Moreover, since the Rivera litigation was in California, the defendant publisher was able to go on the offensive under the state’s anti-SLAPP statute, which provides for expedited dismissal of claims that threaten the exercise of First Amendment freedoms.  Rivera agreed that product liability claims seeking to impose broad, massive liability on independent publishers based on the content of what they published threaten free speech.  Plaintiffs may not use litigation to sue others into silence:

Here, the act on which the complaint against defendant is based is the confusing language and format of the monograph, in other words, publication.  There are no allegations against defendant except this exercise of free speech. . . .   As plaintiffs themselves affirmatively declare in the respondents’ brief, defendant “is being sued exclusively because of the contents of its [drug] monograph.”  Thus the free speech factor is satisfied.

Id. at 5-6.  Information about prescription drugs was in the “public interest,” id. at 6, something that the GAO report’s discussion of the role currently played by independent drug/device information only reinforces.  Cf. Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2655-56 (2011) (holding that information used in drug detailing is protected by the First Amendment).

Several of the other publisher liability cases discussed above have also cited First Amendment concerns in rejecting such claims.

The expression of opinions upon matters of public concern is the core value protected by the First Amendment.  To subject authors of such opinions to the risk of multiple claims for personal injuries, at least in those instances, as here, in which the opinions do not address or impugn any specific individual, based solely upon the majoritarian view that the opinion is “false,” would impose an intolerable burden upon the author of such opinions.  And, the imposition of such a burden would have a ruinous and unjustifiable chilling effect upon free speech.

Bailey, 952 P.2d at 773.  See Vess, 317 F.3d at 1110 (defendant’s “protected speech . . . consists of the publication of the DSM); Jones, 694 F. Supp. at 1217 (“to do so could chill expression and publication which is inconsistent with fundamental free speech principles”); Development Corp., 432 F. Supp. at 993 (“Merck's right to publish free of fear of liability is guaranteed by the First Amendment”); Libertelli, 1981 U.S. Dist. Lexis 11049, at *6 (“the applicable First Amendment standard for imposing liability on publishers for erroneous informational articles is substantively indistinguishable”).

As far as free speech is concerned, our initial 2011 screed against publisher liability contains what we hope is a complete list of non-drug/device publisher liability cases relying in whole or in part on First Amendment considerations to reject holding publishers liable for the substantive accuracy of everything they publish.  There’s not a great deal of updating to be done, since thankfully this sort of case remains rare.  We did find one new First Amendment case to pass along:  Rosenberg v. Harwood, 2011 WL 3153314 (Utah Dist. May 27, 2011) (plaintiff could not sue Google maps for negligent directions; “the high social utility of Google’s information services and the accompanying First Amendment values” require rejection of claim against online publisher).

Thus, as much as we discounted publisher liability claims in 2011, they’re even less tenable now.  Specifically in the context of prescription medical products such claims have been rejected on the merits in California, New York, Pennsylvania, New Jersey, Maryland, Colorado, and Arkansas.  Such claims have been allowed . . . nowhere.  It’s rare to find such legal unanimity, but it exists here.  In this area, it’s past time for courts to stop engaging in the fiction that because their particular jurisdiction isn’t one of those seven, publishers are possible defendants, since no court has yet adopted a plausible theory on which publisher liability could exist.  It’s bad law, bad policy, and unconstitutional to boot.  There is no good faith basis under current law for asserting such claims.

2 comments:

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Anonymous said...

So patients, consumers, shouldn't read the drivel that First DataBank and others publish because it may be unreliable? Why shouldn't such publishers be liable for their own mistakes? And if your justification is that there is a societal benefit to drug information in the marketplace, why should victims of these mistakes bear the burden alone?
Maybe the FDA should get involved or the publisher should be required to put a warning or disclaimer on the information letting people know it isn't trustworthy.
The information shouldn't be entitled to any more First-Amendment protection than shouting "Fire" in a crowded theater.