In very general terms, posts on specific court opinions fall into three categories: 1) ones we think are correct, 2) ones we think are incorrect, and 3) ones we think are mixed bags. Not terribly profound. Digging a bit deeper, we sometimes pick cases to discuss because we feel the need to vent about the poor reasoning the opinion displayed or how we think the case speaks to a larger issue that bears highlighting. In other words, sometimes a rant needs to be unleashed. As we said recently, 2020 was an annus horibilis, so we might have started off 2021 with a rant about one of the worst decisions of 2020, a late entry onto our ignominious list. Instead, we are going to try to start with something positive from a recent decision (and an honorable mention), an affirmance of a grant of summary judgment in a case with a sympathetic plaintiff and no supported claims. We think there is something apt about starting off this year with such a case, but our readers can draw their own links to the year that was and the hopes for the year to come.
Hubbard v. Bayer Healthcare Pharms. Inc., __ F.3d __, 2020 WL 7550285 (11th Cir. Dec. 22, 2020), is familiar in a few ways. First, it involves the blood clot risk with combination oral contraceptives. We have commented many times on how plaintiff lawyers have pursued litigation about this class of medications, along with their attack on just about every new contraceptive drug/device over the last fifty years. The effect, we have said, is decidedly anti-reproductive choice, something about which reasonable public health minds do not differ. The disclosure of the clotting risk with hormonal contraceptives has had significant regulatory impacts (e.g., patient package inserts) and the litigation over it has helped develop product liability law in terms of the learned intermediary doctrine and other modern bedrocks. We (including the blog-specific singular version) have many posts about decisions coming from litigation over contraceptives, often alleging issues with the warnings about the risk of blood clots (arterial and venous). We could go on about this, but we will not.
Second, it involved a case filed directly into an MDL in early 2014, remanded in 2018 with summary judgment pending (sometime after the close of relevant case-specific discovery), a grant of summary judgment by the remand court (N.D. Ga.) in 2019, and an affirmance by the Eleventh Circuit in late 2020. Because of the MDL process, and perhaps the particularities of this MDL, it took close to seven years to get a final resolution (we think) on what ended up being a fairly discrete issue once the prescribing physician was deposed. Without doing a survey of summary judgment rulings from the “Yaz” MDL, we can point to some of our posts on the plaintiff-leaning decisions that came out of it, like here and here. It may have ended up being good for the defendant that this MDL in the Southern District of Illinois did not rule on the pending summary judgment motion under Georgia law and that a Georgia federal judge did, but it was not efficient. We can hypothesize that the trend where MDL courts push large-scale settlements by, among other things, not granting summary judgment on unsupported and/or time-barred cases played some role here.
Third, although the consequences of plaintiff’s injury were particularly bad—paralysis and cognitive impairment from a venous sinus thrombosis, rightly described by the Eleventh Circuit as “tragic”—the basic facts relevant to summary judgment were relatively normal in such cases. The plaintiff had been prescribed a related group of combination oral contraceptives—all with the same progestin, drospirenone, and made by the same company—for eleven years before her stroke. Id. at **1 & 4. Over time, she switched to lower estrogen medication and, ultimately, to one with folate added to it (to minimize the risk of neural tube defects in offspring). While the knowledge of blood clot risks among women using hormonal contraceptives during this decade or so was extensive, experienced prescribing physicians like plaintiff’s had followed the studies, labels, and regulatory actions related to the various medications and their respective blood clots risks. In fact, two weeks before plaintiff received her first prescription for the third drug in December 2011, there was a widely publicized series of FDA advisory committee meetings about these issues for a number of medications. For the drospirenone-containing medications, FDA communications about possible increased risk compared to other classes of medications led, while plaintiff was still having prescriptions renewed in 2012, to FDA-mandated labeling changes about the latest thinking on the studies. Id. at *3. Six months later after her medication’s label changed, plaintiff experienced a stroke from a venous clot. (As the label noted, the risk venous clots is highest in the first year of use, so a clot after more than a decade of combination oral contraceptives was usual and a venous clot leading to a debilitation stroke even more so.)
On summary judgment, the defendant did not challenge medical causation or the adequacy of the warning, just that plaintiff could not establish proximate cause for any failure to warn. The plaintiff conceded that her other claims would fail if she lost proximate cause on failure to warn. The parties agreed that Georgia law controlled and the learned intermediary doctrine applied, so there was one issue to decide the case: did plaintiff carry her burden to show that her physician would have prescribed a different drug and avoided her injury if provided with an adequate warning as to the risk of blood clots. The district found that she did not and the Eleventh Circuit reviewed de novo.
The court’s prior decision in an antidepressant case called Dietz defined the proximate cause inquiry: “in cases where a learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same court of action even with the information the plaintiff contends should have been provided, courts typically conclude the causal link is broken and the plaintiff cannot recover.” Id. at *5. (We would change “typically conclude” to “must” to make this a proposition, but it accurately reflects that courts sometimes do not follow the law to avoid granting summary judgment.)
Ignoring the order of the court’s analysis, we start with the rejection of plaintiff’s argument that Georgia has a rebuttable presumption on proximate cause with an inadequate warning (or where inadequacy was not contested on summary judgment). This argument was contrary to the decision in Dietz and unsupported by any Georgia state appellate authority, so it was easy to reject consistent with Erie restraint. Id. at *10. In any event, the testimony from the prescribing physician would have rebutted any presumption that applied. Id. at *11.
The court’s evaluation of that testimony touches of recurring issues in prescriber testimony, particularly in the context of hormonal contraceptive litigation and/or cases where the label changes while the plaintiff is taking the drug.
Dr. Rowley “provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings,” as well as the information found in Bayer’s updated 2012 Beyaz label, he would still have prescribed Beyaz to Karen Hubbard. Moreover, Dr. Rowley’s testimony indicates that he already knew in December 2011 what he considered to be substantially the same risk information later included in the 2012 Beyaz label. The causal chain is therefore broken, and the Hubbards cannot establish proximate cause.
Id. at *6 (citation omitted). Weighing the information available as of the time of his deposition, the prescribing physician still considered his prescription appropriate. For plaintiff, this was particularly because she had been taking drospirenone-containing oral contraceptives without issue for many years and his practice was to continue such patients unless they developed a contraindication (presumably like a known clotting factor abnormality). Plaintiff herself was satisfied with these medications and requested refills for years.
In addition, the information in the 2012 label did not present a significant change in the risk calculation for someone who had had been on the medications for years. The prescriber concluded “the benefits of Beyaz outweigh the risk in patients who have been taking it for some time with no problems,” like plaintiff. Id. The 2012 label was consistent with what he knew when he prescribed Beyaz to plaintiff in 2011, there was a possible increased risk of VTE with drospirenone-containing contraceptives compared to those with different progestins. Id. at *7. As would be expected, he had known for decades “that all birth control pills carry a risk of blood clots,” had kept up on the literature over time, including the 2009 studies suggesting a higher risk, and had stayed abreast of the labels and FDA announcements before the 2011 prescription to plaintiff at issue. In this context, the 2012 labeling that plaintiff contended might have changed the prescribing physician’s decision with plaintiff did not change his prescribing practice or cause him to reach a new conclusion about the level of blood clot risk with Beyaz. Id. at *8. This sort of testimony negates proximate cause. (The court also relied on Dietz in rejecting the argument that an objective, rather than subjective, standard applies to the decision of the actual prescriber, which might have opened the door to evidence of what a different prescriber might have done in his shoes. Id. at *8 n.8.)
Plaintiff tried a version of what often gets raised when a prescribing physician stands by her decision to prescribe the drug at issue to the plaintiff. She latched onto the prescriber’s testimony that his counseling of patients about Beyaz changed with the 2012 label, suggesting she could carry her burden on proximate cause by suggesting her own testimony on what we would have done with different counseling should control. The court rejected this because “a change in communication practices says nothing about the 2012 label’s impact on Dr. Rowley’s decisionmaking regarding whether to prescribe Beyaz; indeed, Dr. Rowley continued to prescribe Beyaz, YAZ, and Yasmin after 2012.” Id. at *9 (emphasis in original). For someone like plaintiff, who had done well for years, he was not going to recommend a switch to a different medication. She also pointed to his testimony that his prescriptions of the drospirenone-containing medications dropped with the 2012 labeling change, but this did not suggest that he would have changed his decision to prescribe to plaintiff in 2011 after a decade of use without issues to that point. Id. This drop was not because of the doctor’s thinking, but because “the patients themselves decided not to be on those prescriptions.” Id. Getting in the wayback machine, we know there were lots of lawyer ads in 2012 about litigation over these drugs (and other contraceptives), highlighting the FDA actions and labeling changes in the way they tend to do. The negative impact such advertising has had on the practice of medicine has gotten some attention, but that impact should never provide proof of proximate cause for an alleged failure to warn.
So, the remand court and the Eleventh Circuit did the right thing once the MDL had run its course. It can be hard to look past tragedy and follow the rule of law, but we hope to see more rule of law and less tragedy in 2011. The reality with prescription medical products is that they have risks and sometimes those risks manifest in bad outcomes for patients who were adequately warned about those risks by physicians who knew enough to make decisions about prescribing the products and counseling their patients. New risk information almost invariably comes out over the life cycle of a prescription product, but not all new risk information would have changes the decision to prescribe the product to the patient at a specific point in time. We applaud the prescribers who resist the litigation pressure and stand by their own decisions. We also applaud the courts that follow the law even when the plaintiff is sympathetic.