WD Pa. Applies comment k to prescription drugs for animals

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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 while they will never be granted the exact same civil rights as humans (who are, after all, animals too), we will surely find ways to reduce unnecessary animal suffering. Several of the smartest legal scholars we know – Epstein, Nussbaum, Posner, and Sunstein – have written interesting articles 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 have been a pretty bad keeper of fish. A long time ago, we already tried the common parenting ploy of replacing a dead goldfish. The DDL girl was not fooled. We have a difficult relationship with horses. Well, let’s say it: they scare us. Besides, the horses seem to know it. Every horse we rode – even one of the supposedly super sweet Icelandic horses – seemed delighted to terrify us. But we know a lot of good people, including the DDL girl and our recent test partner, who are horse people (i.e. they love horses; we don’t call them centaurs) , so we will attribute our mistrust to another of our character flaws.

Is this the first article on this blog on horse law? No! This isn’t even the first article on a particular equine antibiotic. Here’s the mane, uh, the main point: Horse law can be closely related to human law. In the new decision of Foge, McKeever LLC v Zoetis, Inc., 2021 WL 4479718 (WD Pa. September 30, 2021), the court applied comment k to prescription drugs for animals. The plaintiffs had argued that this doctrine of limitation of liability applied only to humans. But the defense has succeeded in showing that prescription drugs, whether for humans or animals, have formula attributes and regulatory requirements that make them much more similar than different. The federal court ruled that the Pennsylvania commentary k doctrine should apply to the equine antibiotic as well because the k comment rationale does not distinguish between prescription drugs for humans and animals.

The facts of the case are sad, which immediately reminds us of the tender feelings one can have for animals. The plaintiffs owned a standardbred filly named Saratoga Gia. He was a successful racehorse. A veterinarian injected medicine into Saratoga Gia to treat a puncture wound. The horse suffered a severe reaction, collapsed and ultimately perished. The plaintiffs claimed that the defendant was aware of many similar side effects, but failed to adequately warn them. The plaintiffs brought actions for negligence, strict liability, breach of express warranty, breach of implied warranty of merchantability, fraud and negligent misrepresentation. The defendant requested that the complaint be dismissed,

Several complaints suffered from irregularities in pleading. Let’s start with the negligent failure to warn claim, which did not specify which warnings were missing and did not plausibly link the alleged injuries to the failure to warn. The negligent design claim did not specify how the drug’s design was flawed. He also did not describe a safer alternative. The negligent manufacturing defect claim was devoid of any allegation as to what was wrong with the manufacturing process. The express warranty claim offered only conclusive and non-fact-specific allegations. The allegations of fraud and negligent misrepresentation did not have the necessary specificity under rule (b). For example, the claims did not identify any specific representations or advertisements. All of these claims were dismissed, but the complainants were given the opportunity to try again and do better.

This is not the case with strict liability claims and breach of the implied warranty of merchantability. The court ruled that these requests were prohibited in law. This is where the comment k played a decisive role. The scope of comment k is the subject of some controversy under Pennsylvania law. Complainants, for obvious reasons, hate comment k and always try to restrict its application. For example, the complainants currently argue that comment k should not apply to medical devices. They are wrong about it, and they were wrong in the Fog cases to try to isolate animal drug cases from comment k. The Supreme Court of Pennsylvania in the Hahn The case concluded that comment k to Section 402A of the Restatement (Second) of Torts denied the application of strict liability to products such as prescription drugs. Such products are “inevitably dangerous” but at the same time are justified for some patients. Commentary k contains no textual restrictions that might override the application to animal drugs, and the political concerns are quite similar. So the Fog the 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.

In addition, under Pennsylvania law a claim for breach of the implied warranty of merchantability is “coextensive” with strict liability claims. 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 field of prescription drugs, holding that “the very nature of prescription drugs precludes the imposition of a guarantee of fitness for ordinary purposes” . Therefore, the implied warranty claim was also rejected with prejudice.

We agree with the Fog court analysis, congratulate the defendant on his intelligent and successful arguments, and mourn poor Saratoga Gia. So please don’t ask us “why the long face?” “


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