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It seems like litigation over TNF inhibitors (used to treat auto-immune conditions) consistently presents extremely interesting legal issues.  After all, it was a TNF inhibitor (Remicaid) case that produced our #1 2012 decision, Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012).  Another TNF inhibitor, Humira, also produced a couple of very bloggable recent opinions.

Now we’ve found another one, DiBartolo v. Abbott Laboratories, 2012 WL 6681704 (S.D.N.Y. Dec. 21, 2012). While not complete a win as the previous three, DiBartolo did get the big things right.  DiBartolo presents the standard medical profile of TNF inhibitor litigation.  Plaintiff is prescribed a TNF inhibitor to treat an auto-immune disease (here, severe psoriasis) and is later diagnosed with a form of cancer (here, non-melanoma skin cancer – on the tongue).  That’s because “TNF” stands for “tumor necrosis factor” – meaning a substance that kills (necrosis) tumors. If you “inhibit” that (which also reduces the inflammation characteristic of autoimmunity), you inhibit something that the body uses to fight cancer.  Do that, and the risk of cancer goes up.

If even we can explain the science in a couple of sentences, then you can bet that the risk is well-known and warned about.  DiBartolo, 2012 WL 6681704, at *2 (detailing extensive “malignancy” warnings – specifically including non-melanoma skin cancer).  Indeed, with respect to psoriasis, the FDA even imposed a requirement that the defendant manufacturer “publish a Medication Guide to inform patients directly of Humira’s risks.”  Id. at *3.  This booklet also warned specifically about non-melanoma skin cancer.  Id.

However, this particular plaintiff, who had “struggled with psoriasis periodically throughout her life,” only took Humira after trying several other therapies – including something called “PUVA” (which involves UV light).  As anybody who’s ever had a sunburn knows, UV exposure can kill skin cells (for those fortunate enough to have avoided the annoying “heartbreak of psoriasis” commercials of yesteryear, it’s a skin disease).  DiBartolo, 2012 WL 6681704, at *1.

Despite both physician- and patient-directed warnings about the precise type of cancer the plaintiff suffered, plaintiff sued anyway.  New York law applied in DiBartolo.  Id. at *5. The defendant moved to dismiss, hoping to blow the entire complaint right out of the box.  Eight theories of liability were at issue: negligent and strict liability variants of warning, design and misrepresentation claims (3 x 2 = 6), and express and implied warranty.  Id. at *6.

As to warnings, the learned intermediary rule of course applied.  See Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993).  The plaintiff in DiBartolo, however, was desperate to evade the rule.  The first thing the plaintiff tried, similarly to the Texas plaintiff in Hamilton, was to argue that the rule was some sort of “affirmative defense.”  That assertion was rejected:

[The rule] is not an affirmative defense under New York law, but rather defines the scope of a drug manufacturer’s duty to warn of the risks of its drugs. It is immaterial that, in two other currently pending cases, Abbott has pled under the category of “Affirmative Defenses” that “Plaintiff’s claims are barred in whole or in part by the learned intermediary doctrine.” . . . [Defendant’s] listing of [the rule] under “Affirmative Defenses” was not an admission that the doctrine is an affirmative defense, but rather appears to have been simply the product of a conservative litigation strategy.

DiBartolo, 2012 WL 6681704, at *6 n.3. That’s an important point.  A lot of us plead things as “affirmative defenses” that aren’t really “affirmative” – in the sense that we have the burden of proof.  Failure to state a claim is one of these.  Here the plaintiff tried to turn such “conservative litigation strategy” into a judicial admission and was shot down.  We’ve had that concern in the backs of our minds for some time now, and if plaintiffs are going to play this game, it’s probably time, at least, to call them “defenses” rather than “affirmative defenses.”  A word to the wise…..

Having failed to escape the learned intermediary rule via the burden of proof, plaintiff cast around – equally unavailingly – for some exception to the rule.  Again, as in Hamilton, plaintiff tried for a direct-to-consumer exception.  Plaintiff falsely claimed that Restatement (Third) of Torts, Products Liability §6(d) (which recognizes only a mass immunization exception, somehow included a DTC exception as well.  DiBartolo, 2012 WL 6681704, at *8.  The court quite rightly rejected that novel proposition, pointing out the express comment (comment e) to that section noting but not taking a position on a DTC exception.  Id. at *8 n.3.  The court then held that New York would not adopt such an exception:

At any rate, section 6 of the Restatement (Third) of Torts: Products Liability is not good law in New York. . . .  [T]he New York Court of Appeals has not adopted it . . . and plaintiff cannot even cite an Appellate Division decision adopting the section.  It is immaterial that the Court of Appeals has adopted other sections of the Restatement (Third) of Torts: Products Liability. Contrary to plaintiff’s suggestion, moreover, there is no trend in favor of recognizing a DTC exception.

Id. at *9 (citations omitted).

As an extra bonus, DiBartolo provides a forceful, double-barreled rejection of the reasoning in Murthy (opinions from which have made our bottom ten lists for both 2011 and 2012).  First, as to the purported DTC exception, Murthy simply got Texas law wrong.  2012 WL 6681704, at *9 (Murthy’s “prediction turned out to be incorrect; in June of this year, the Texas Supreme Court reversed the appellate court decision relied on in Murthy”).  Contrary to Murthy, DiBartolo concluded that there is simply no reason for a DTC exception:

Even in a world with widespread DTC advertising, however, physicians continue to fulfill the core functions that underlie [learned intermediary rule]:  they evaluate a patient’s needs, assess the risks and benefits of available drugs and then prescribe a drug, advising the patient of its risks and possible side effects.  The physician therefore remains an “informed intermediary” to whom manufacturers should direct prescription drug warnings.  Indeed, although it may be true that DTC advertising encourages patients to ask specifically for the advertised drug, a physician who prescribed a drug to a patient simply based on the patient’s request, without an individualized medical assessment, would likely be liable for malpractice.  In such a situation, a failure-to-warn claim against the manufacturer would raise a serious issue of causation.

2012 WL 6681704, at *9 (citations and quotation marks omitted).

Second, DiBartolo flatly rejected Murthy’s would-be physician compensation exception to the rule:

Plaintiff alleges that here, [defendant] compensated physicians in various ways. . . .  This argument fails on both the law and the facts.  On the law, plaintiff has not cited any New York decision that adopts an exception to [learned intermediary rule] where physicians received compensation from drug manufacturers.  Murthy applied Texas law, and plaintiff has not demonstrated that Murthy is part of any trend supporting an exception to [the rule] where drug manufacturers compensate physicians.  On the facts, moreover, plaintiff’s allegations that [defendant] compensated [the prescriber] are completely speculative.

2012 WL 6681704, at *10.  Murthy was simply wrong on this point as well:  (1) “Such [compensated] physicians would not be absolved of their duty to prescribe drugs to patients only when medically appropriate.”  Id. at *10 n.6.  (2) “It is not clear . . . that manufacturer-compensated physicians would in fact neglect their professional duties to an extent that would undermine “ the learned intermediary rule.  Id.

Nonetheless, despite the defendant’s quite explicit warnings, the court did not dismiss the claim outright on the pleadings.  Instead, the court let (for now, acknowledging serious “causation” problems once the prescriber is deposed) the plaintiff slide on a bass-ackwards warning theory – that while the patient brochure was adequate in explicitly warning that PUVA increased skin cancer risk, the package insert directed to the prescriber didn’t contain the same explicit language.  DiBartolo, 2012 WL 6681704, at *11-12 (“[plaintiff] alleges that by not including similar language [to the patient insert] in its label, [defendant] failed to appropriately warn”) (citation and quotation marks omitted).


Our two cents are this theory is “implausible” right now, regardless of future prescriber reliance testimony.  As a matter of fact the plaintiff admitted that there was an adequate warning directly to her regardless of the learned intermediary rule – the very PUVA warning that plaintiff claimed should have been on the “label” for the prescriber to read was given directly to the plaintiff in the brochure. While the duty to warn may run only to the prescriber, causation can be severed at any point, and here the FDA-mandated patient brochure skipped over the prescriber and adequately warned the patient about PUVA and increased risk. There is no logic to the warning theory allowed to proceed in DiBartolo.

In any event, we continue.

The design defect claims failed, for two reasons.  First, there was no “substantial likelihood of harm” from the design itself, since a proper warning would have taken care of the problem:

Plaintiff concedes that the likelihood of harm from Humira induced [skin cancer] would have been minimal if [defendant] had properly warned [the prescriber]. . . .  Thus, plaintiff admits that had she been appropriately screened and monitored for [skin cancer],” her injuries would have been completely negated or otherwise minimized. Therefore, Humira did not pose a substantial likelihood of harm as designed.

DiBartolo, 2012 WL 6681704, at *15 (emphasis original).  In other words, if an adequate warning would have fixed the problem, there can’t be a design defect.  Second, plaintiff was TwIqballed for failure to plead any facts showing a feasible alternative design, as required for all design defect claims under New York law.  Id.

The misrepresentation claims also failed.  As for strict liability misrepresentation, New York has never adopted Restatement (Second) of Torts §402B (1965).  DiBartolo, 2012 WL 6681704, at *16 (quoting one of our Bone Screw cases – a gift that keeps on giving).  As for negligent misrepresentation, there was no privity.  Id.

Express warranty bit the dust for the usual reason – failure to plead any false statement.  Id. at *17.  That claim also failed for a less usual reason.  Many of the statements pleaded were simply irrelevant, pertaining to off-label uses.  Plaintiff, however, was prescribed the drug on-label.  Id. at *18 (such “overstatements [of the intended use] do not constitute breach of express warranty because [plaintiff] could not have relied on them to her detriment.  [She] fit within the class of patients for whom the FDA had approved Humira”).

Finally, we’re disappointed but not surprised that plaintiff’s implied warranty claims survived.  DiBartolo, 2012 WL 6681704, at *19-20.  Ever since the awful decision in Denny v. Ford Motor Co., 662 N.E.2d 730 (N.Y. 1995), New York law has permitted an idiosyncratic version of implied warranty based on subjective consumer expectations with none of the safeguards of product liability.

That’s DiBartolo – all in all we have to say that two out of three (or four out of six) ain’t bad – particularly given the learned intermediary rule rulings.