Even a casual reader of the blog would know that we like it when drug or device manufacturers defeat dubious claims. It is also no secret that we are enamored of the learned intermediary doctrine and challenging the link of proximate cause for failure to warn. We also value decisions that use common sense, at least what our biased perspective allows us to see as common and sensical. When these things come together, we are as pleased as a robin finding juicy, wriggling worms after the spring thaw.
The decisions in Averhart v. Ortho-McNeil Pharm., Inc., No. 3:09 oe 40028, 2014 U.S. Dist. LEXIS 38446 (N.D. Ohio Mar. 24, 2014), and Casso v. Ortho-McNeil Pharm., Inc., No. 1:11 oe 40006, 2014 U.S. Dist. LEXIS 38443 (N.D. Ohio Mar. 24, 2014), largely satisfy our annelid cravings. First, the defense won summary judgment on the warnings claims they moved on in each case. (The defense moved for judgment on the pleadings on some other claims and apparently raised some new arguments for summary judgment in reply briefs. Defendants were rebuffed in almost all of those attempts. We cannot tell from the decisions why summary judgment was not sought across the board or if the plaintiffs had any evidence for their non-warnings claims, so we will focus of the warnings part of the decisions.) Second, the warnings claims fell because the prescribers testified to their understanding of the risk at issue and the plaintiffs had nothing else suggesting that the warnings were inadequate in any material way. Third, the warnings analysis, despite some quirks of the phrasing of the applicable Mississippi and Minnesota law, was pretty straightforward, focusing on the actual testimony of the prescribers and some of the basics of how drugs are prescribed to patients.
The drug at issue in these cases was Ortho-Evra, a combination hormonal contraceptive patch; “combination” means that there is estrogen with the progestin. It has long been common knowledge in the medical community, and, we think, the population of patients who use hormonal contraceptives, that this class of products has a risk of blood clots. Patient package inserts started forty years ago because of this risk with these products. Advertisements for these products on television and in popular magazines have identified this risk since the 1990s. There has been litigation for decades over various hormonal contraceptives and their risk of blood clots (among other things). Because of this, to say nothing of medical journals, medical schools, and medical education, it is hard to imagine healthcare providers making decisions on prescribing hormonal contraceptives without being aware of the risk of blood clots and at least thinking about what to tell the patient about the risk with the product or products that might be prescribed. Because of the nature of hormonal contraception, it is particularly important that the prescriber and patient work together to identify the particular medication that the patient will actually use as directed. The risk of blood clots present in all marketed prescription combination hormonal contraceptives goes up with pregnancy–that is, when contraception fails—so the risk-benefit decision for prescribing a particular contraceptive is very much tied up patient-specific considerations. Thus, for warnings claims on blood clots, there are some obvious challenges for plaintiffs: (1) that the claims are for inadequate warnings rather than failure to warn completely, (2) that prescribers will typically be well-versed in the risks regardless of the label, and (3) decisions to prescribe one combination hormonal contraceptive instead of another will usually not be based on a comparison of their blood clot risk. This means the manufacturers of these products should have a good chance of getting summary judgment on inadequate warnings claims for the risk of blood clots.
The principal hurdle to summary judgment in Averhart was the argument, based on a minor consent statute, that Mississippi’s codification of the learned intermediary doctrine did not cover prescriptions written by a nurse practitioner. The argument goes something like this: (1) in Mississippi, “contraceptive supplies and information may be furnished by physicians to any minor . . . who has the consent of his or her parent or legal guardian”; (2) plaintiff, a minor at the time, had written consent from her mother when she went to the Health Department clinic to get contraception; (3) after an exam and counseling, plaintiff selected the Ortho Evra patch and received samples from a nurse practitioner without the direct involvement of any physician; (4) it does not matter what warnings went to the nurse practitioner or what she knew about the risk of blood clots, because she was not a physician; and (5) the focus, absent a learned intermediary, is on the plaintiff, who denies being warned of the risk by the nurse practitioner. There are many things wrong with this argument, without even addressing the wisdom of limiting contraception to minors in Mississippi. Among them, the decision rightly focused on the leap from a consent statute saying “may be furnished by physicians” to concluding that nurse practitioner do not count as learned intermediaries for contraceptives prescribed to minors. “Nurse Practitioners have the authority to write such prescriptions. This statute allows nurse practitioners to write prescriptions for most medication, and, most importantly, neither the administrative code nor the statute than enables it limits a Mississippi nurse practitioner’s ability to prescribe contraceptives to minors.” 2014 U.S. Dist LEXIS 38446, **9-10 (internal citations omitted).
We quibble with the decision’s characterization of the learned intermediary doctrine as a “defense” and its suggestion that a genuine question of fact as to the adequacy of the warning to the learned intermediary means that the manufacturer of a prescription drug has a duty to warn the patient directly, but this decision clearly came to the right result. If state law allows a non-physician healthcare professional to prescribe a drug, then she is a learned intermediary. For contraceptives, prescriptions are often written at clinics, run by the state Health Department or otherwise, and the clinics by necessity provide a chunk of their services by nurse practitioners. Prescription drug manufacturers do not pick who prescribes their drug. Different law for two lawsuits over prescriptions of the same drug at the same clinic on the same day, one written by a physician and one written by a nurse practitioner, would create more problems than we could list here.
That is not necessary, though, because the focus was properly on whether the nurse practitioner was adequately warned. While the NP testified that she read the package insert and was aware of the relevant risk, plaintiff countered with the NP’s lack of recollection of reading a particular Dear Health Care Provider letter. (They are not generally called “Dear Doctors” letters anymore because drugs are prescribed by other providers. Such foolish consistency, plaintiffs.) This did not amount to “evidence indicating did not adequately warn NP Dedeaux.” Id. at *11. “Since NP Dedeaux testified she understood that Ortho Evra created a risk of the very thing that happened to Ms. Averhart, Defendants have shown they warned the learned intermediary (through whatever means) adequately.” Id. We read this as also cutting off proximate cause—“where a different warning to the prescribers would have changed the prescribing decision”—because the NP’s knowledge of the risk makes additional warnings pointless. Id. at *7. We also note that plaintiff’s expert evidence on the adequacy of warnings, if she had any, was not addressed. This also makes sense. If the prescriber knew the risk, then expert opinions about additional or different warnings of that risk do not have much chance of changing the analysis.
The Casso case involves a prescription written by a physician, so it skips the first part of Averhart. Like Averhart, we could quibble with the idea that Minnesota law provides that “[a] proper warning of a drug’s danger to the prescribing doctor obviates the duty to disclose the danger directly to the consumer,” but we do not get to where that matters because the prescriber’s testimony ended the inquiry. 2014 U.S. Dist. LEXIS 38443, *8. The prescribing physician testified that he was “familiar with and took into consideration all of the information” in the most recent label and Dear Healthcare Professional letter. Id. at **8-9. As often happens with prescribers, his testimony was that he did not “have a specific recollection” of receiving the letter, but “it is my practice to read all of the letters from manufacturer [of drugs] that I’m prescribing.” Id. at *9. In response to this and the prescriber’s “acknowledgement that he understood each [danger of Ortho Evra] at the time he prescribed the drug to Ms. Casso,” plaintiff could just offer a spin on testimony about offering the patient choices. Id. at *10. As we noted earlier, patient choice plays a significant role in the prescription of contraceptives. The prescriber “would have stated to her that the IUD was a safer option for her than combination hormonal contraception” as part of “practice to discuss relative safety of contraceptive options.” Id. at **10-11. The court rightly rejected the argument that this testimony suggested he did not understand the risk of blood clots when he prescribed Ortho Evra to plaintiff or that the warnings at that time were inadequate. So, the warnings claim did not survive summary judgment.
It will be interesting to see how far these cases can go on their surviving non-warnings claims. To our eye, given the prescribers’ respective knowledge of the risk of blood clots and the existence of revised warnings about the risk based on post-approval interaction with FDA, those claims do not have legs. Much like worms. (And we are not talking about polychaetes. Those things are just weird.)