Warnings & Labels Expert Witness

Overview

About Warnings & Labels Expert Witnesses

A warnings expert answers whether a warning told the right person the right thing, in a form they would notice, understand and act on, and whether a better one would have changed what happened. The last part often decides the case. A label can be poor and still make no difference if the injured person never saw it, already knew the hazard, or would have ignored it. This page covers the design and adequacy of warnings. Product liability counsel handles the legal duty, and a design engineer addresses whether the hazard should have been removed.

One point runs through this field: a warning is rarely the first answer to a hazard. Designers are usually taught to remove a hazard first, guard against it second, and warn only for what remains. So warnings disputes often sit next to a design claim, and the expert should know which one is being asked. OSHA's machine safeguarding guidance reflects the same idea by treating devices that detect but do not prevent exposure as something other than primary safeguarding methods ⁹.

What the Rules Require

No single federal rule covers warnings, so the first task is to identify which one applies:

• Household hazardous substances. The Federal Hazardous Substances Act treats a household product as misbranded if its label does not state required information conspicuously ². CPSC's rule says cautionary statements must be located prominently and appear in conspicuous and legible type, in contrast by typography, layout or color with other printed matter on the label ¹. It defines the signal word as DANGER, WARNING or CAUTION ¹. It also sets type size and placement policies, so the expert can measure the label ¹.
• Workplace chemicals. Under OSHA's Hazard Communication Standard, label elements are the pictogram, hazard statement, signal word and precautionary statement for each hazard class and category ⁴. Danger is used for the more severe hazards, and warning for less severe ones ⁴.
• Workplace signs and tags. 29 CFR 1910.145 sets colors and classes. Employees must be instructed that danger signs indicate immediate danger and that special precautions are necessary, and danger tags are used only in major hazard situations with an immediate threat of death or serious injury ³. The rule refers to ANSI Z535.1-2006(R2011) for safety colors ³.
• Drugs and devices. These are regulated by the FDA, and their labels raise the preemption issues below.

A product may also fall outside all of these, and then consensus standards and the state duty to warn set the frame. Compliance with a regulation is evidence, and how far it answers a claim depends on state law.

The Questions in a Failure to Warn Case

An expert usually works through a sequence:

• Was there a hazard the seller knew of or should have known of? This requires incident data, testing and complaint history.
• Who was the audience? A label for a trained installer differs from one for a child's parent. Language, literacy and the setting of use all matter.
• Was it noticed? Placement, size, contrast, clutter and where the eyes are during the task.
• Was it understood? Whether the words describe the hazard, the consequence and how to avoid it.
• Would it have been followed? Whether a different warning would have changed the behavior of this person. This is causation, and it is often the weakest link for the plaintiff.

Expert opinions here are open to attack. A witness who drafts a new label for trial should expect to be asked whether it was ever tested. Testing a proposed warning, or relying on published research on comparable warnings, makes the opinion sturdier under Rule 702 ⁸.

Preemption

Federal law may displace some claims, and the answer changes by product:

• Prescription drugs. Wyeth v. Levine held that federal law did not pre-empt a claim that a drug's label lacked an adequate warning ⁵. Merck v. Albrecht then said a pre-emption defense needs clear evidence, meaning the manufacturer fully informed the FDA of the justifications for the warning and the FDA informed it that it would not approve the change ⁶.
• Premarket approved devices. Riegel v. Medtronic held that the Medical Device Amendments bar common-law claims challenging the safety or effectiveness of a device marketed in a form that received premarket approval ⁷.

Counsel should settle this early, because it may determine what the warnings expert is allowed to say.

Who Is Qualified, and Who Does What

No license applies. Look for a human factors professional with training and research in warnings, or an engineer with product safety experience who has written and tested warnings. In a drug case, the witness on regulatory conduct is usually a former FDA or industry regulatory professional, and a physician addresses what prescribers would have done. Ask for the expert's own testing and what research supports the opinion.

Qualifications

Qualifications to Look For

• ✓Human factors or engineering background with training in warnings design
• ✓Experience writing, reviewing, or testing product warnings and instructions
• ✓Knowledge of the rule that applies to the product, such as FHSA, OSHA, or FDA labeling requirements
• ✓Knowledge of the ANSI Z535 family of safety sign and label standards
• ✓Ability to test comprehension and noticeability, or to rely on published research that fits
• ✓Experience with the injury and complaint data for the product category
• ✓Prior deposition and trial testimony experience, including Rule 702 challenges

FAQ

Frequently Asked Questions