Standard of Care Issues – Defendant’s Perspective

The defense may argue that compliance with a statute or regulation equals safety. It does not. In some instances they may take that argument a bit further and say that because they did comply with a government regulation or statute at the federal level, that therefore there is federal preemption that applies. Federal preemption is a somewhat different issue and is not addressed in this particular blogpost.

Compliance With Regulation Does Not Equal Safety

The first step in terms of combatting any compliance argument is to identify the regulation that the defense is relying upon.

The key fallacy in any such compliance argument is that courts across the country have ruled that compliance with a regulation does not equal safety. In re: CR Bard, Inc., 810 F.3d 913 (4th Cir. – 2016), the 4th Circuit confirmed that in regards to a transvaginal mesh case. Other courts have gone the same way in regards to building codes, FAA standards and other standards. Wyeth v. Levine, 555 U.S. 555 (2009)

Notable Examples

There have been a number of instances over the years where products that complied with applicable regulations were in fact found to be dangerous or deadly. Examples of those are the Boeing 737 Max, the Ford Pinto, Johnson & Johnson Baby Powder, the Takada air bags and tobacco.

In the Bard case referenced above, the court actually went a bit further and affirmed the District Court finding that compliance evidence carries a significant risk of misleading the jurors. Bard 810 F.3d at 922, 932

Any such compliance argument needs to be met head-on. It probably is going to have to be met head-on through an expert that you call. The direct examination should expressly address the issue of whether or not compliance with a regulation means that the condition or product is safe. You should then ask the expert for examples of where compliance indeed does not establish safety such as the ones mentioned above.

Frequently in regards to particular products, the certification process for compliance with a regulation may be based upon what is called self-certification.

The federal government in particular allows self-certification for purposes of economy. That self-certification process is based upon the company who is making the product having the knowledge and integrity to in fact fully test the product and certify that it is safe.

As such any such compliance that is based upon self-certification is further premised upon the knowledge and integrity of the entity that is providing the self-certification.

All of that may be flawed.

See the posts on this site dealing with standard of care issues:
medical malpractice standard of care issues.
standard of care issues plaintiff’s perspective