Trial Magazine - December 1, 2025
Flip the ‘Compliance Equals Safety’ Defense
Defendants Often Argue that Regulatory Compliance Proves Products Safety. Expose the Gap Between Compliance and Safety to Show that Checking a Box Doesn't Close the Case.
In many areas of civil practice – pharmaceuticals, transportation, consumer products, and more – defendants routinely claim their product is safe simply because it complies with a government regulation. This argument often surfaces in motions to dismiss based on federal preemption, where the defendant claims federal law preempts the plaintiff’s ability to bring a civil claim. But this is not an article about preemption, which has been the subject of abundant litigation and writings, including in Trial.
Rather, this is a discussion of how to address a far more common tactic: a defendant’s claim that its product is safe because it complied with some law or regulation. Without adequate preparation and understanding of the applicable regulatory regime, this argument can both stop your case from getting to the jury, and – once there – be a persuasive argument for the defense.
The first step is to identify the defense, which is simple enough. Sometimes, it’s right there in the answer as an affirmative defense: “Defendant’s product was not defective because it complied with [regulation X].”
At times, a defendant’s claim that it complied with government regulations is wrong. For that reason, it is worth exploring in discovery whether the defendant’s claim that it complied with the stated regulation is true.
Often, however, it is true – the product or practice did comply with a regulation. Usually, some regulatory approval is required before a product can be sold, like with the FDA. Federal Aviation Administration (FAA), and National Highway Traffic Safety Administration (NHTSA). The duties and responsibilities of these agencies include reviewing certain product features before they reach consumers. This creates a challenging, and common, scenario: The plaintiff must overcome the true statement that defendant’s product did comply with some applicable regulation.
The defendant can wield compliance and regulatory approval as a powerful tool in court, often repeating familiar refrains like:
- “The government said we could sell this, so it must be safe.”
- “We did everything we were supposed to do.”
- “We followed the rules. You can’t expect us to do more.”
This narrative can appear throughout the litigation, from pleadings and dispositive motions to expert reports and trial arguments. It is up to the plaintiff lawyer to first identify the defense, and, more importantly, know how to deal with it.
Compliance Does Not Equal Safety
The key fallacy in the defendant’s argument is its attempt to equate two terms that are not equal: “regulatory compliance” and “safety.” To the contrary, courts across the country have consistently held that compliance with a regulation does not prove a product is safe.
The Eleventh Circuit explained, “While compliance with a statutory standard is evidence of due care, it is not conclusive on the issue. Such a standard is no more than a minimum, and it does not necessarily preclude a finding that the actor was negligent in failing to take additional precautions.”1
This principle was front and center in In re C.R. Bard, Inc., a case involving transvaginal mesh. The defendant sought to introduce evidence that its product complied with FDA regulations. The district court excluded that evidence, concerned that lengthy testimony about regulatory compliance could mislead the jury into conflating that compliance with safety. The Fourth Circuit affirmed the lower court’s ruling.2
Other courts have reached the same conclusion across various regulatory contexts: building codes,3cruise ship safety protocols,4 FAA standards,5 FDA drug approvals,6 and plumbing systems.7 The message is clear: Regulatory compliance does not equal safety.
This well-established rule rests upon sound principles. History offers stark examples of products that complied with applicable regulations but were later found dangerous or deadly: the Boeing 737 MAX, the Ford Pinto, Johnson & Johnson baby powder, Takata air bags, and tobacco products. From the outset, the “compliance equals safety” defense conflicts with decades of U.S. history.
Presumptions Aren’t Proof
In some states and contexts, regulatory compliance is prima facie evidence creating a rebuttable presumption that the product is safe.8 If the presumption applies and the plaintiff fails to counter with sufficient evidence, the plaintiff’s case may be over:
While compliance with a statute or regulation is not conclusive evidence in itself of due care, it is properly viewed as prima facie evidence of due care . . . Hence, in the absence of any evidence offered by [plaintiff] that the defendant . . . compl[ied] with . . . the requirements of state statutory regulations, [plaintiff] fails to show a breach of any duty of the defendant.9
In rare cases, courts exclude evidence of regulatory compliance under Federal Rule of Evidence 403 (or a state equivalent), recognizing the risk of confusing the jury.10 In re C.R. Bard, Inc., again provides strong precedent, with the Fourth Circuit affirming the district court’s finding that compliance evidence carries a significant risk of misleading jurors.11
However, more often, courts allow defendants to introduce such evidence. While not dispositive, compliance may be viewed as some proof of due care.12 Be ready to confront it head-on at trial.
In a trial involving a tour helicopter crash in New York’s East River, we argued that the defective design of the harness meant to secure passenger Trevor Cadigan also prevented his escape in an emergency.13 He drowned after the helicopter lost engine power, crashed into the river, and rolled upside down when its safety floats failed to deploy properly. The defense countered that the harness complied with all FAA regulations.
In response, we called an expert witness with extensive expertise in federal aviation regulations. He began with the foundational point: Compliance does not equal safety.
Direct examination went like this:
Q. When an aircraft is certified as compliant with Federal Aviation Regulations, does that mean the aircraft is safe?
A. No.
Q. Can you give a recent example?
A. The Boeing 737 MAX. The system is good, but it’s not perfect. Flaws sometimes emerge only after crashes occur. Boeing had two examples of this.
By using an example that we thought the jury might have heard about, this testimony anchored the idea that compliance does not equal safety.
But that’s not all. In many fields, the way to achieve compliance is heavily reliant on a manufacturer’s own disclosures to government agencies through “self-certification.”14 At trial, our expert explained the process to the jury.
Q. Why do we have a self-certification process in this country?
A. Well, if we didn’t have a self-certification process, the FAA would probably have to hire another 75,000 or 100,000 people to do a 100% inspection. Right now, the FAA achieves that 100% inspection through the utilization of the designees. You have to understand the FAA system throughout. Its cornerstone is based on knowledge and integrity.
Q. Knowledge and integrity?
A. Knowledge and integrity.
By introducing the idea that compliance requires a great deal of “knowledge” and “integrity” by the manufacturer, the jury could question whether the defendant-manufacturer fulfilled its end of the “self-certification” bargain.
When asked what happens if a manufacturer lacks honesty and integrity during self-certification, our expert’s answer was sobering:
Q. My question for you is, if manufacturers and operators do not display honesty and integrity during this self-certification process, what’s the result of that?
A. It could be catastrophic. It leads to an unnecessary exposure of risk. It doesn’t need to happen. The outcome is some people pay with their lives.
By the time our expert was finished, any “presumption” of safety was sufficiently rebutted, and the jury was armed with adequate facts and information to reject the manufacturer’s argument that regulatory compliance equals safety.
For the rest of the trial, every time the defendant made the “compliance equals safety” argument, we felt a collective eye roll from the jury. Not only did our expert expose the fallacy underpinning the defendant’s entire argument, but we also gave the jury evidence to question whether the manufacturer actually acted with sufficient “knowledge and integrity” to achieve compliance in the first place. We hammered these points in closing argument, and, in the end, it felt like we had turned one of the defendant’s central arguments into one of our strengths.
The regulatory compliance defense is not going away anytime soon. Dealing with it requires attention, research, and a plan. With careful and deliberate strategy, defendants’ “compliance equals safety” defense can be cut off at the stem, exposed for what it is, and become a weapon for the plaintiff.
Andrew C. Robb is a partner with Robb & Robb in Kansas City, Mo., and can be reached at acr@robbrobb.com.
NOTES
1 Adinofle v. United Tech. Corp., 768 F.3d 1161 (11th Cir. 2014).
2 In re C.R. Bard, Inc., 810 F.3d 913 (4th Cir. 2016) (expressing concern that extensive testimony on regulatory compliance could mislead jurors into equating compliance with safety; noting that although 510(k) clearance might tangentially reflect product safety, it says nothing specifically; rejecting the notion that regulatory clearance proves product safety).
3 Gillespie v. Heartland Scenic Studio, Inc., No. 2019-cv-08807 (S.D.N.Y. 2021) (“Even if the step did comply with the New York City Building Code . . . that fact would not be dispositive of the issue of negligence. Compliance with a building code does not establish due care; compliance is only some evidence of due care.” (quoting Nipon v. Yale Club of N.Y.C., No. 13 Civ. 1414 (HBP), 2014 WL 6466991, at *7 (S.D.N.Y. Nov. 18, 2014)).
4 Smith v. Royal Caribbean Cruises, Ltd., No. 1:13-cv-20697, 2014 WL 11456074 (S.D. Fla. 2014) (holding that compliance with standards is not determinative of negligence where additional precautions may be required).
5 Buschmann v. Little Rock Nat’l Airport, No. 4:14-cv-347, 2005 WL 620034 (E.D. Ark. 2005) (holding that compliance with FAA regulations reflects adherence to minimum standards but does not provide immunity if a safer alternative existed).
6 Wyeth v. Levine, 555 U.S. 555 (2009) (holding that compliance with FDA requirements does not establish adequacy of a warning label).
7 Preferred Mut. Ins. Co. v. Barros Co., Inc., No. 15-cv-13414-FDS, 2018 WL 3977122 at *9 (D. Mass. Aug. 20, 2018) (noting that while compliance with a statute or regulation is prima facie evidence of due care, it is not conclusive).
8 Mutual Ins. Co. of Am. V. Royal Appliance Mfg. Co., 112 Fed. App’x. 386 (6th Cir. 2004) (finding that OSHA compliance created a rebuttable presumption of product safety).
9 Parker v. Town of Swansea, 270 F. Supp. 2d 92 (D. Mass. 2003).
10 Fed. R. Evid. 403.
11 In re C.R. Bard, Inc., supra note 2, at 922, 932.
12 See Gillespie v. Heartland Scenic Studio, Inc., supra note 3.
13 Cadigan v. Liberty Helicopters, Inc., No. 152286 at *816 (N.Y. Sup. Ct. filed 2018).
14 Kirsten Brueggemann, HHS Secretary Instructs FDA to Consider Rulemaking to Remove Process Allowing Companies to Self-Certify Food Ingredients Are Safe, Am. Bar Ass’n Health L. Sec. (Mar. 25, 2025), www.americanbar.org/groups/health_law/news/2025/3/hhs-secretary-fda-rulemaking-self-certify-food-safety/; Aaron C. Davis & Marina Lopes, How the FAA Allows Jetmakers to ‘Self Certify’ That Planes Meet U.S. Safety Requirements, Wash. Post, Mar. 15, 2019, tinyurl.com/3xpz9m9v.
