Here's the legal definition of negligence. I await Craig's explanation of how this does not apply to Amarex's failure to keep proper records (thus making the data useless), and failing to fill out the forms properly, despite the FDA's guidance.

Quote:

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Negligence is the failure to behave with the level of care that a reasonable person would have exercised under the same circumstances. Either a person’s actions or omissions of actions can be found negligent. The omission of actions is considered negligent only when the person had a duty to act (e.g., a duty to help someone because of one’s own previous conduct).

Negligence is a foundational concept of tort law. Some primary factors to consider in ascertaining whether a person’s conduct lacks reasonable care are the foreseeable likelihood that the conduct would result in harm, the foreseeable severity of the harm, and the burden of precautions necessary to eliminate or reduce the risk of harm. The following five elements may typically be required to prove negligence:

The existence of a legal duty that the defendant owed the plaintiff
Defendant’s breach of that duty
Harm to the plaintiff
Defendant’s actions are the proximate cause of harm to the plaintiff
Defendant’s actions are the cause-in-fact of harm to the plaintiff

https://www.law.cornell.edu/wex/negligence

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