This is a follow-up post on the case of Knapp v. Zoetis, Inc. – an animal drug case. While not our typically fare, it is still a prescription drug case involving adverse event reporting to the FDA and the learned intermediary doctrine. So, while this patient had four legs instead of two, the legal framework is primarily the same.
A year ago we reported on the court’s decision to drastically cut down the case by tossing out the class allegations and dismissing without prejudice plaintiff’s negligence and implied warranty claims. New year, new complaint, new decision. This time the court let plaintiff gallop out of the starting gate.
To refresh your memory – plaintiff owned a horse named Boomer. When Boomer started experiencing leg swelling, a veterinarian administered an injection of an equine antibiotic manufactured by defendant called Excede. Plaintiff alleges Boomer suffered an adverse reaction to the antibiotic causing the horse to experience persistent lameness and permanent damage to the musculature in his neck. Knapp v. Zoetis, Inc. 2022 WL 989015, *2 (E.D. Va. Mar. 31, 2022). Based on the decision it appears plaintiff ponied up two primary arguments. First, defendant reported nearly 600 adverse events to the FDA, “some of which included similar symptoms to Boomer’s.” Id. at *7 (emphasis added). Second, Excede is an extended-release antibiotic that uses a “cottonseed oil suspension” in its delivery system. Id. at *3. Apparently that was enough for the court to say giddy up.
For this lap around the track, plaintiff re-alleged her express warranty claim (the only claim that survived the prior the motion to dismiss) along with amended claims for negligent failure to warn, negligent design and manufacture, and breach of implied warranty. Plaintiff also sought punitive damages. Id. Under Virginia law, both negligence and implied warranty claims require a showing that the product was unreasonably dangerous for its ordinary or reasonably foreseeable use. Id. at *5. Here the drug was administered to Boomer for an off-label purpose. But because plaintiff alleged defendant was aware veterinarians used the drug off-label, the court found such use was reasonably foreseeable. Id. at *7.
On design defect we must first reiterate a view often expressed in our posts – design defect does not make much sense as a theory of liability for a prescription drug. As the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.” Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2475 (2013). So, even when plaintiff can articulate how a compound could be altered, the change would make the drug a different product. So, on design defect we think the court should have said nay rather than spurring the claim along.
In concluding plaintiff plausibly alleged a design defect, the court relies heavily on the “nearly 600” adverse events reported to the FDA — creating a classic case of damned if you do, damned if you don’t. Plaintiffs attack defendants for failing to report adverse events and now for properly reporting? Whoa! The fact that the drug was FDA approved and that the FDA took no action upon receipt of this significant number, in the court’s view, of reported events should have cut against the plausibility of a design defect, not in favor.
Then there is the issue of a safer alternative design – a requirement under Virginia law. The court’s reasoning on this one came up lame. Plaintiff focuses on Excede’s extended-release mechanism. Plaintiff argues that other equine antibiotics without such a mechanism do not cause the type of reaction Boomer experienced. In fact, the safer alternative design plaintiff relies on is another antibiotic manufactured by the defendant called Naxcel. Naxcel is a “non-extended release injectable” antibiotic. Id. at *8. Naxcel is also a different product. Saying Naxcel is an alternative design is the same as saying defendants must stop selling Excede. Plaintiff’s complaint may not talk in terms of withdrawing Excede from the market, but it is implied when they say Excede should really be Naxcel. Afterall, defendant cannot just change the formulation of or the delivery mechanism of Excede without going through a new FDA application process. The court overlooked all these issues holding instead that the question of whether the delivery mechanism would “fundamentally alter” Excede was a jury question. Id. at *9.
The court allowed plaintiff’s manufacturing defect claim to proceed based on what appears to be an unsupported allegation that the cottonseed oil used in the drug may have been unrefined or improperly refined. Sounds to us like this claim should have failed TwIqbal. We will take this part of the decision in stride since it seems like a fairly case-specific issue.
That left just failure to warn – where the court seems to want to beat a dead horse. Because defendant reported adverse events with Excede to the FDA and, because Naxcel did not have the same type of adverse events, defendant knew or had reason to know Excede had risks that should have been warned about. Id. at *10. The court also found plaintiff adequately pleaded causation under the learned intermediary doctrine by alleging that defendant failed to warn both her and her veterinarian. Id. at *9.
The last thing the court considered was whether to strike plaintiff’s claim for punitive damages. Punitive damages are not available for breach of contract. So, the court had to decide if plaintiff’s warranty claims sounded in tort or contract. Under Virginia law a claim sounds in contract if based on nonfeasance, whereas a claim based on misfeasance or malfeasance is a tort. Because plaintiff alleges that defendant “affirmatively performed in such a way that injured her horse,” her warranty claims were based in tort and were sufficient to allow plaintiff to seek punitive damages. Id. at *12-13.
All in all, this decision has left us with a bit of a long face.