We are sometime not sure what to make of pharmacy monographs. You know what we mean. Those sheets that pharmacists print out and give us with our prescriptions. They are not drug labeling, and they are not medication guides. They are summaries intended for patient perusal, with information taken from the labeling, but digested in a fashion intended for the lay reader. Notably, the FDA has not asserted any prerogative to review and approve pharmacy monographs, leaving publishers essentially self-regulated under an FDA action plan.
From time to time, we are surprised when a plaintiff produces a pharmacy monograph in discovery, one that he or she received from the pharmacy and has saved. (We have not seen the data, but we expect that people who save pharmacy monographs are the same people who have their utility bills from the mid 1990s and who know where the instructions and warranties are for all their household appliances.) But even when this happens, we are unsure how the monographs help us. The parties we represent – drug manufacturers – do not publish these things, and they generally don’t have any duty to warn patients anyway.
In a way, pharmacy monographs are more useful to the other side because they give plaintiffs someone else to sue – the monograph publishers. We have commented on this before (here and here) and noted that lawsuits against publishers have met with virtually no success, and for good reason. Publishers do not make prescription drugs; they do not sell or dispense prescription drugs; and they have no relationship or contact with the plaintiffs. That is to say, they owe plaintiffs no duty of care, which is and should be enough to stop litigation.
Unfortunately, it was not enough to stop litigation in Hardin v. PDX, Inc., No. A137035, 2014 WL 2768863 (Cal. Ct. App. June 19, 2014), a case involving the prescription anticonvulsant lamotrigine and alleging the awful skin condition Stevens-Johnson syndrome. In addition to suing the drug manufacturer and the pharmacy, the plaintiff sued the publisher of the pharmacy monograph that she received. Id. at *2. Of course, in a common exercise of post hoc rationalization, the plaintiff claimed that if the monograph had mentioned SJS, she would not have taken the medicine. (We do not question the plaintiff’s veracity, but we wonder about the reliability and relevance of such a statement made after a person has actually experienced a drug complication, when the condition is no longer an abstract risk.)
The publisher moved to strike the claims under California’s anti-SLAPP statute and won on the sound and correct basis that it owed the plaintiff no duty. In so ruling, the trial court relied on California’s marquee case on this point, Rivera v. DataBank, Inc., 187 Cal. App. 4th 709 (2010), which rejected a duty on the part of a publisher because the publisher, as neither a drug manufacturer nor a seller, had no obligation to provide any information to the plaintiff at all. Hardin, at *2.
Having lost against the publisher, the plaintiff reached one step further and sued the company that provided the software through which the pharmacy obtained and printed its monographs. Id. That smacks of desperation, but it’s possible that the plaintiff is staring generic preemption in the face. The software company was a mere “pass through” for content written for someone else, possibly the publisher or perhaps the pharmacist. In addition, although the usual monograph was eight sections, this particular pharmacy (a large chain) requested and received software specially revised to produce an abbreviated five-section monograph. That is what the plaintiff allegedly received, and it did not include a warning against serious skin rashes. Id.
So let’s review. The plaintiff was suing a software company that did not make anything, did not sell her anything, did not write the monograph, did not give her a monograph, and gave the pharmacy access to an abbreviated monograph meeting specifications set by the pharmacy itself. The pre-electronic analogue would be suing the manufacturer of white-out over the omission of something from a letter. The monograph publisher owed this plaintiff no duty, and the software company was one step further removed from this plaintiff and her alleged injury.
The software company therefore owed this plaintiff no duty either, right?
That should have been the result, but the California Court of Appeal felt differently and affirmed the trial court’s order denying the software company’s motion to strike. First, the court attempted to distinguish Rivera by observing that the alleged deficiencies in the Rivera monograph were not as serious as the alleged shortcomings in the lamotrigine monograph. Id. at **4-5. This is result-oriented reasoning at its best, and it reads like a court stretching to explain away a case that is clearly controlling. More to the point, what does this have to do with duties of care or the First Amendment (remember, this was an anti-SLAPP motion)? The publisher in Rivera owed no duty because it had neither a relationship with the plaintiff nor an obligation to provide information. The same is true in Hardin for the software company. The fact that the monograph in Rivera purportedly was not so bad goes to breach of duty, which is irrelevant when there is no duty in the first instance.
Second, the court found a duty in what we have previously called the last refuge of scoundrels –“Good Samaritan” liability under Restatement (Second) of Torts § 324A. This concept holds that a person who undertakes to render services necessary to protect another is subject to liability resulting from a failure to exercise reasonable care. Here the court considered it important that the software company had revised its software to permit access to an abbreviated five-section monograph. The court stated as follows:
Here, Hardin presented evidence that PDX [the software company] knew that enabling Safeway [the pharmacy] to print the abbreviated monograph could place patients at risk, including, notably, the acknowledgement in its 2006 agreement with Safeway that providing the full eight-section version would better enable patients to “use the medication properly and appropriately, receive the maximum benefit, and avoid harm.” This record sufficiently makes out a claim that PDX assumed a duty of care by undertaking to render services to Safeway “of a kind [it] should have recognized as necessary for the protection of third persons . . .”
Hardin, at *6. We use the saying “this argument proves too much” in carefully chosen spots, including this one. This argument proves too much because the subject matter at issue is prescription drug monographs. All drugs present risks to human health, and anyone who prepares or transmits information regarding the use of prescription drugs can foresee a possible impact on patients. As a result, this court’s rationale would produce a duty with no end, which is clearly not the law in California or anywhere else. Nor should it be. Even this court had to concede that no other court in California has ever found such a duty.
We hope and expect that Hardin will be an outlier. It is wrongly decided, and its reasoning relies on circumstances that we hope are unique. And we have not even mentioned the other issues that pharmacy monographs present, such as First Amendment chilling effects of “Good Samaritan” liability and the learned intermediary doctrine, which recognizes only a duty running from the manufacturer to the physician. When all is said and done, we think the software company in Hardin got stuck holding the short end of the stick.