Thursday, May 09, 2013
Big Sky Beat Down
We read rulings under the Federal Tort Claim Act about as often as we read bench trial rulings or rulings from the District of Montana. Or rulings where a judge says he is retiring in two days. That is, with a frequency somewhat below what our diminishing memory can recall. In Holtshouser v. United States, No. 11-114-BLG-RFC, 2013 U.S. Dist. LEXIS 62607 (D. Mont. May 1, 2013), we satisfied all four of these rare (for us) criteria.
In some ways, though, the case was very familiar. The plaintiff claimed to have developed tardive dyskinesia and aggravation of Parkinson’s Disease symptoms from use of generic metoclopramide for severe GERD and diabetic gastroparesis on and off for several years; the branded from of metoclopramide is known as Reglan and we have discussed a few decisions on cases involving branded and/or generic metoclopramide over the years. Also familiar was that the plaintiff, a 91 year old Navy veteran, was what is known affectionately as a “train wreck,” with at least 15 different chronic medical conditions, at least 20 different medications a day, and frequent visits with a variety of health care providers during the period of use and injury at issue in the case. (We say plaintiff, but Mrs. Holtshouser sued, presumably for loss of consortium—an aggressive position under the circumstances.) He seemed to have a significant need for the metoclopramide, having failed on other therapies, and the metoclopramide seemed effective when he was on it. It also looks like the patient and all the prescribers had their eyes open about the risks of the metoclopramide, particularly when using it beyond the periods identified in the label. In our jaundiced eyes, while these facts suggest no good claim against the branded or generic manufacturer, we expect one or both of them would get sued. Nope. The suit was only against the U.S., based only on the alleged negligence of the pharmacy at the Veteran’s Administration that dispensed the metoclopramide to plaintiff. None of the VA or private prescribers were sued for negligence. Just the pharmacy.
The choice here is what interests us. We have ranted a few times about the misguided expectation of many lawyers and some courts that a person injured by the use of a medication should always have someone from whom to recover. We assume that, before filing the complaint on September 30, 2011, plaintiff’s counsel mulled over which potential defendant(s) to sue, the best theory to urge, where to sue, and such. We assume that plaintiff’s counsel noted that the Supreme Court decided Mensing on June 23, 2011, and shut down the chance of a suit against the (generic) manufacturer of the drug the plaintiff actually took. We suspect that plaintiff’s counsel read the wind on Conte innovator liability—maybe from some snarky blog—and figured Montana would not endorse liability against the branded manufacturer. (We do not think Montana courts or courts guessing at what Montana courts would do have chimed in yet.) We wonder if plaintiff’s counsel read through the lousy Montana Supreme Court in Stevens v. Novartis and saw that the learned intermediary doctrine was followed in Montana, thought about the rejection of the heeding presumption in Riley v. American Honda Motor Co., 856 P.2d 196 (Mont. 1993), and/or found the prescribers would not support any failure to warn. Based on the suit that was brought, we have to assume that whatever analysis happened pre-suit determined that suing the deep pocket manufacturers was a dead end or not worth it.
When smart zoos build new enclosures and want to ensure that the planned inhabitants cannot escape, they try out the enclosures with orangutans. Our forest cousins have the combination of brains, agility, strength, curiosity, and a desire to get out that puts wannabe Houdinis to shame. We would not compare plaintiff lawyers to orangutans—we like orangutans and hope they prosper in their natural habitat—but the plaintiff lawyers do have a way of coming up with someone to sue and something to say they did wrong, regardless of the legal walls or factual moats they have to traverse. We cannot say that the decision in Holtshouser represents any kind of trend of how plaintiffs who took generic drugs will try to proceed post-Mensing in a venue that has not followed the Conte nonsense. First, pharmacy liability is generally not an easy route on the typical facts. Most jurisdiction, as detailed in this post, reject it. In Montana, pharmacies have to pass on manufacturer warnings and only have to do more (like warn the patient or contact the prescriber) if they know something about the patient that puts him at extra risk with the medication prescribed. 2013 U.S. Dist. LEXIS 62607, **26-27. Second, when it comes to government pharmacies—which do dispense a big chunk of the prescription drugs in the U.S.—proceeding under the FTCA involves three aspects that plaintiffs tend not to like: (1) pre-suit administrative requirements, (2) bench trials only, and (3) no punitive damages. Other than the money saved with a three day bench trial compared to a longer jury trial, we have a hard time seeing what was appealing to plaintiff and his lawyer about bringing this suit.
We do not really have to understand why it was brought, though. We can just sit back and read the Court’s numbered and logically organized findings of fact and conclusions of law. The result, you may have guessed by now, was fairly predictable – the plaintiff lost because he could not establish any breach by the VA. The opinion provides a new angle on familiar topics of prescription drug labeling, labeling changes, off-label use and dueling experts. The court found that doctors rely on medical literature rather than the label for information on the drug’s risks and uses. Id. at *21. It also found that most drugs are prescribed off-label, including for longer that the duration specified in the label. Id. The U.S. offered an expert who testified that “a manufacturer’s label is not proscriptive, and does not prohibit use for a longer period, or in any other manner not described in the labeling” and “a licensed prescriber can prescribe [an approved] drug for any use either within or outside of the label, if doing so, in the opinion of the prescriber, is in the best interests of the patient.” Id. at **21-22. We note that this is not exactly the position the U.S. takes in False Claims Act cases. The expert the plaintiff offered in response did not know the standard of care for pharmacists in Montana, but contended that that the VA’s “integrated system” with a centralized dispensary in Kansas brought along some sort of heightened standard of care. Id. at **22-23. This sounds much like standard of care testimony offered against drug manufacturers, but this court saw through the testimony as just “her personal standard of care that had no concept of the reality of operation of the VA system in Montana.” Id. at *23. It is nice when reality is part of the standard of care. Some plaintiff experts can be so divorced from reality that they even write their own (lousy, trashy) fiction in their spare time. The apparent advantage of the bench trial is that the judge can listen to the expert’s whole spiel as the fact finder before deciding to give it no weight. We would like to see more judges exercise their gatekeeper function up front and protect juries from hearing an expert’s mere “personal standard of care.”
Because that was all that the plaintiff offered in Holtshouser, and because he had no evidence that the pharmacy actually did know something about him that made him uniquely susceptible to the risks of metoclopramide, he lost. We will not decry the waste of tax dollars in defending this suit. Plaintiff got his day, or rather three days, in court. It happened to be before a judge who got it before he rode off into the sunset. We are sure that the next potential plaintiff facing the same hurdles as Holtshouser faced pre-suit will not be sufficiently deterred to do the novel thing and not sue anybody. Deciding to sit still can be difficult even if you are stuck.