As large swaths of the country continue to get pounded by a variety of winter precipitation, we know that there are many over-the-counter cold and flu preparations being consumed by our readers. We assume many of our readers have minor children who are taking the pediatric versions of these preparations after suitable review of the labeling by their respective parents. The labeling does not just tell the reader how much to take or how often to take it, but discloses actual risks. Other than to whom the manufacturer’s duty to warn runs, the causes of action available for plaintiffs suing over OTC drugs are pretty much the same as for prescription drugs. Some risks of OTC medications rival risks of prescription drugs, in terms of severity of the injury if not its frequency. The risk we seem to post about most often in OTC cases drug is Stevens-Johnson Syndrome (and its related Toxic Epidermal Necrolysis), which is usually quite nasty.
The risk, however, is not new. Without laying out a comprehensive labeling history, we can say that OTC ibuprofen-containing preparations have had warnings since before 2006, when the labels for adult and pediatric versions were revised in connection with FDA action on a Citizen’s Petition. Yet, we still see cases where plaintiffs sue over SJS they say they got from ibuprofen in pediatric OTC cold preparation. As we have said many times, we have a hard time seeing the basis for imposing liability on a drug manufacturer for an injury the risk of which was adequately described in the label, especially a label the FDA specifically revised in terms of how that risk was described. We have also said, particularly since Bartlett, that claims based on the need to change one drug to a different drug, to the extent they could be cognizable under any state’s design defect law, should be preempted. We posted last year on Newman v. McNeil Consumer Healthcare, No. 10 C 1541, 2013 U.S. Dist. LEXIS 113440 (N.D. Ill. Mar. 29, 2013), a case involving warnings and design defect (and other) claims over SJS from a pediatric OTC ibuprofen preparation. In decrying that court’s ruling allowing design defect to proceed based on the contention that a different drug was an alternative feasible design, we wrote famously—checking to see if our readers’ collective ego-meter is working—“A cat is no more an alternative design of a dog than acetaminophen is an alternative design of ibuprofen.”
In Hunt v. McNeil Consumer Healthcare, Civ. No. 11-457, 2014 U.S. Dist. LEXIS 14263 (E.D. La. Jan. 17, 2014), we see a case with the same product and similar allegations that cites the Newman decision—but not our post. Hunt involved alleged SJS from use of the product in February 2010—the date is not mentioned in this decision—and allegations of failure to warn and design defect under the Louisiana Product Liability Act. (We are not picking on Louisiana. We are told we have enjoyed some of our trips to the state.) Defendants moved for partial summary judgment on the design defect claim and to exclude one of plaintiff’s experts. We pause here to express some confusion. The defendants did not move on the warnings claim even though the product was used with the FDA-mandated SJS warnings. The partial motion for summary judgment was said to be “Granted in Part,” but it looks to us like it was denied except that plaintiff “clarified” that she “intends to offer evidence” only as one of three purported alternative designs identified by one of her experts. Id. at **7-8. (We wonder if plaintiff dropped acetaminophen as an alternative design because of the August 2013 FDA announcements about acetaminophen and SJS.) The elephant in the room on design defect for a drug is impossibility preemption, but the court pointed out in a footnote that Defendants did not assert it and the court would not consider it sua sponte. Id. at *8 n.1. And, while part of this decision considers a motion to exclude one expert who opines on causation and damages, the Defendants apparently did not move on the expert who was opining on warnings and design defect. That expert, Randall Tackett, is a fairly well-known and well-worn shill for the other side, who we have mentioned here and here. As discussed below, his opinions that helped create the genuine issues of material fact to defeat the motion for partial summary judgment might have been excludable under strong Fifth Circuit Daubert law. Maybe there is more going on in this case than is apparent from the decision itself or maybe the Defendants will get another shot to raise preemption and/or knock out Tackett.
So, now that our expression of confusion has given away the result in Hunt, we can return to our analysis. The court correctly assigned the burden on plaintiff to prove that “a safer alternative design existed at the time” the plaintiff’s product was manufactured and “that the risk avoided by using the alternative design (magnitude of damage discounted by the likelihood of its occurrence) would have exceeded the burden of switching to the alternative design (added construction costs and loss of product utility).” Id. at *7 (quoting Roman v. W. Mfg., Inc., 691 F.3d 686, 700-01 (5th Cir. 2012)). The alternative design that plaintiff urged, based on Tackett’s testimony, was dexibuprofen, which, as we explained before (but Hall did not), is the right-sided stereoisomer of racemic mixture ibuprofen. The rub is that FDA rejected a New Drug Application for dexibuprofen in 1994 and it cannot be marketed in the U.S., let alone sold OTC. Tackett’s opinion that “FDA would now grant an NDA for dexibuprofen” was unchallenged, even though—preemption aside—it is rank speculation and does not, as characterized, go to the potentially relevant issue. Id. at *11. The real question was whether a pediatric OTC containing dexibuprofen would have been approved in time for it to be on the shelves by February 2010. Without a long regulatory discussion, where the active ingredient is not already legally marketed in any form, obtaining pediatric OTC approval would be harder than a “standard” NDA, which is not easy even without a prior rejection. Presumably, Tackett’s guess was really as to this question and plaintiff had evidence from him or someone else satisfying the risk/burden part of LPLA design defect law. That meant the question for the court was a straight legal one: Does the requirement that “[t]here existed an alternative design” mean that the alternative design had to have been legal?
The court concluded that the Louisiana legislature’s choice of “existed” was a rejection of requiring that the alternative design have been “feasible,” as is the law in many jurisdictions. Id. at **8-9. According to a law review article by a lawyer who helped draft the LPLA, “existed” really just means that someone somewhere had “conceived” the alternative design such “that the manufacturer had a realistic choice as to design” (between what was used and the identified alternative). Id. at **9-10. Based on this, the court concluded that a drug not on the market could be an alternative design if there was “evidence” like what Tackett offered. Id. at *11. Significantly, as far as we know, this non-FDA-approved alternative design theory has been rejected by every state court judge and every appellate decision to have considered it. See Ackley v. Wyeth Labs., Inc., 919 F.2d 397, 401-02 (6th Cir. 1990) (applying Ohio law); White v. Wyeth Labs., Inc., 533 N.E.2d 748, 753-754 (Ohio 1988); Militrano v. Lederle Labs., 769 N.Y.S.2d 839, 847-848 (N.Y. Sup. 2003), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006); Totterdale v. Lederle Labs., 2008 WL 972657 (W.Va. Cir. Mar. 19, 2008).
The court did not address the more fundamental question of how a different drug, approved or not, can be an alternative design, on which this plaintiff should lose under the LPLA. See Theriot v. Danek Med., Inc., 168 F.3d 253 (5th Cir. 1999). If the idea is to test the reasonableness of a manufacturer’s choice—which sounds like negligence not strict liability—then the real choice of which drug to pursue happens years before any marketing application would be filed. There may not be a real option of pursuing a product with the other drug if rights to its development are held by someone—like a competitor—who does not want to share under any terms. (If the rights bear a Dr. Evil-like price of $100 billion, then is the theoretical choice still a “realistic” one?) Even ignoring preemption, drugs are not like products where the manufacturer really has sole control over the design (e.g., adding a safety guard to a power tool). So, we do not see how “a realistic choice as to design” opens the door to liability for developing and selling one drug instead of another. This leap was done by a federal court predicting what Louisiana courts would do, but without citing a single relevant Louisiana decision. The decision did cite Newman, applying Illinois law, and a federal case applying Texas law, but none of the many decisions saying a different drug—even a stereoisomer—is not an alternative design. This is not a proper result under Erie v. Tompkins.
By comparison, the rest of the decision was fairly restrained and narrow. The plaintiff offered a burn surgeon to opine on general causation, specific causation, and damages. He could not offer general or specific causation opinions because he merely parroted what other experts said without independent investigation of the issues. Hunt, 2014 U.S. Dist. LEXIS 14263, **16-17. The court actually cited some pretty good law Daubert law—we told you it was there—in dispensing with the opinions. The challenge to his damages opinions was apparently limited to qualifications and easily rejected. Id. at **19-21. A pretty obvious result. Nothing to see here. Go play in the snow. With your dog or, alternatively, your cat.