The Drug and Device Law Daughter has told us more than once that the future will see a vast expansion of animal rights. Animals are capable of suffering, and even if they will never be accorded the exact same civil rights as people (who are, after all, also animals), surely we will find ways to reduce unnecessary animal suffering. Several of the smartest legal scholars we know – Epstein, Nussbaum, Posner, and Sunstein – have written interesting pieces on animal rights, raising thought-provoking points about our relationships with animals and what it means to be human.
We love dogs, can take or leave cats, have kept a very long-lived (but, alas, not immortal) parrot, and been a rather poor caretaker of fish. Long ago we once tried the common parental ploy of replacing a dead goldfish. The DDL Daughter was not fooled. We have an uneasy relationship with horses. Okay, we’ll say it: they frighten us. What’s more, horses seem to know this. Every horse we have ever climbed aboard – even one of the allegedly super-gentle Icelandic horses – seemed to delight in terrifying us. But we know plenty of fine people, including the DDL Daughter and our recent trial partner, who are horse people (that is, they love horses; we are not calling them centaurs), so we’ll chalk up our diffidence to yet another of our character defects.
Is this the first post on this blog about horse law? Nay! It is not even the first post about a particular equine antibiotic. Here is the mane, er, main point: horse law can be closely connected to human law. In the new decision of Foge, McKeever LLC v. Zoetis, Inc., 2021 WL 4479718 (W.D. Pa. Sept. 30, 2021), the court applied comment k to animal prescription drugs. The plaintiffs had argued that this liability-limiting doctrine applied only to humans. But the defense successfully demonstrated that prescription drugs, whether for humans or animals, have formulaic attributes and regulatory requirements that make them far more similar than different. The federal court held that Pennsylvania’s comment k doctrine should apply to the equine antibiotic also because the rationale in comment k makes no distinction between prescription drugs for humans and animals.
The facts of the case are sad, which immediately reminds us of the tender feelings we can have for animals. The plaintiffs owned a standardbred filly named Saratoga Gia. She was a successful race horse. A veterinarian injected a drug into Saratoga Gia to treat a puncture wound. The horse experienced a severe reaction, collapsed, and ultimately perished. The plaintiffs claimed that the defendant was aware of numerous similar adverse reactions but failed to warn of them adequately. The plaintiffs brought actions for negligence, strict liability, breach of express warranty, breach of the implied warranty of merchantability, fraud, and negligent misrepresentation. The defendant moved to dismiss the complaint,
Several of the claims suffered from pleading deficiencies. Let’s start with the negligent failure to warn claim, which did not specify what warnings were missing and did not plausibly state a connection between the alleged injuries and the failure to warn. The negligent design claim did not specify how the design of the drug was flawed. Nor did it describe a safer alternative. The negligent manufacturing defect claim was devoid of any allegations as to what went wrong with the manufacturing process. The express warranty claim offered mere conclusory, non-fact specific allegations. The fraud and negligent misrepresentation claims lacked the necessary specificity under Rule (b). For example, the claims identified no specific representations or advertisements. All of these claims were dismissed, but the plaintiffs were afforded an opportunity to try again and do better.
Not so with the claims for strict liability and breach of the implied warranty of merchantability. The court held that these claims were barred as a matter of law. This is where comment k played a dispositive role. The scope of comment k is a matter of some controversy under Pennsylvania law. Plaintiffs, for obvious reasons, hate comment k, and are always trying to curtail its application. For instance, plaintiffs are currently arguing that comment k should not apply to medical devices. They are wrong about that, and they were wrong in the Foge case to try to wall off animal drug cases from comment k. The Pennsylvania Supreme Court in the Hahn case held that comment k to section 402A of the Restatement (Second) of Torts denied application of strict liability to products such as prescription drugs. Such products are “unavoidably unsafe” but are at the same time justified for some patients. Comment k lacks any textual restrictions that could call off application to animal drugs, and the policy concerns are quite similar. Thus, the Foge court showed no hesitation in applying comment k to bar the plaintiff’s strict liability claims for failure to warn, defective design, and manufacturing defect.
Moreover, under Pennsylvania law, a claim for breach of the implied warranty of merchantability is “coextensive” with strict liability claims. More specifically, the Pennsylvania Superior Court in Makripodis ex rel. v. Merrell-Dow Pharms., Inc., 361 Pa. Super. 589, 523 A.2d 374 (1987), applied this principle to the prescription drug arena, holding that the “very nature of prescription drugs themselves precludes the imposition of a warranty of fitness for ordinary purposes.” Accordingly, the implied warranty claim was also dismissed with prejudice.
We agree with the Foge court’s analysis, congratulate the defendant on its clever and successful arguments, and grieve for poor Saratoga Gia. So please don’t ask us, “why the long face?”