Many states have enacted statutes creating a defense to some or all damages if a drug manufacturer complies with requirements imposed by the FDA.
This is already a big issue; it is about to become a bigger one.
As readers of this blog know, the preemption defense is percolating through the courts. Colacicco is first in line for appellate argument (click here for the briefs and then here and here for our subsequent updates), and other cases are rapidly joining the queue.
Win, lose, or draw on preemption, however, state statutes provide a second line of defense. Whether or not compliance with federal regulations automatically displaces state tort law (and we think that it should and does, in appropriate circumstances), state legislatures plainly have the power to declare that manufacturers who comply with federal regulations are immune from suit (or immune from liability for punitive damages) under state law.
In the interest of serving the public good, your humble scribes have identified the following state statutes that protect drug (or, sometimes, device) manufacturers from liability, to lesser or greater degrees, if the manufacturers comply with labeling or manufacturing requirements imposed by the FDA.
Please note that our list does not purport to be comprehensive. First, 50-state surveys are hefty undertakings, and we write these blog posts in our spare time. We’re providing what we know; we don’t promise that it’s all that exists.
Additionally, several states give manufacturers of all products protection of one type or another for complying with federal or state regulations, without specifically mentioning the FDA. Those statutes can be valuable — heck, they can be dispositive — for drug manufacturers, but the statutes don’t specifically mention the FDA, so we’re not listing them here.
Here are the FDA-compliance statutes of which we’re aware. And we’re paraphrasing, not quoting, the relevant statutes; please go back to the original source if you’re defending a case in one of these jurisdictions:
Federal: 42 U.S.C. §300aa-23(d) provides that vaccine manufacturers are not liable for punitive damages unless they engaged in fraud on the FDA in the initial approval process or intentionally withheld safety/efficacy information from the Agency thereafter.
Arizona: Arizona Revised Statutes Sec. 12-701 provides that drug manufacturers are not liable for punitive damages if they complied with FDA regulations, so long as the defendant did not defraud the FDA.
Michigan: Michigan Compiled Laws Sec. 600.2946(5) provides that a drug is not defective or unreasonably dangerous if it was approved by the FDA and sold in compliance with FDA requirements, so long as the defendant did not defraud the FDA.
New Jersey: New Jersey Statutes Annotated Sec. 2A:58C-4 creates a rebuttable presumption that the warning on a drug or device is adequate if the warning was approved or prescribed by the FDA. Section 2A:58C-5 prohibits an award of punitive damages in a case involving an approved drug or device, so long as the defendant did not defraud the FDA.
Ohio: Ohio Revised Code Annotated Sec. 2307.80(C) provides that a drug or device manufacturer cannot be liable for punitive damages if the drug or device was sold in compliance with FDA requirements, unless the defendant defrauded the FDA.
Oregon: Oregon Revised Statutes Sec. 30.927 bars the recovery of punitive damages if a drug is labeled according to the FDA’s requirements, so long as the manufacturer did not defraud the FDA.
Utah: Utah Code Annotated Sec. 78-18-2 bars the recovery of punitive damages if a drug was approved by the FDA, so long as the defendant did not defraud the FDA.
Texas: Texas Civil Practice and Remedies Code Sec. 82.007(b)(1) creates a rebuttable presumption of non-liability if a drug’s label complied with FDA requirements, so long as the defendant did not defraud the FDA.
You can tell from this list that the question whether fraud-on-the-FDA exceptions are preempted under Buckman will also become an increasing hot topic. The Supreme Court may or may not take that issue in Desiano, but the Court is likely to feel compelled to address the question within the next few years.