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Product Defense and FDA Compliance

In the world of pharmaceutical litigation, the jury typically considers FDA approval on issues such as the manufacturer’s compliance with its duty of care, product defectiveness, and state of the art.1 The Restatement (Third) of Torts, Products Liability – adopted in many jurisdictions – states that “a product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective.” By this standard, it is a significant, but not determining, factor. The state of Arkansas makes the distinction that compliance is “evidence” of non-defectiveness.

However, in some states, FDA approval is the determining factor in a product liability case. In this article we’ll study the extent to which FDA approval, clearance, or compliance with government regulations affects the availability of compensatory and punitive damages. Though each statute is unique in its specific language, they generally fall into four groups: (1) statutes containing a presumption against liability based on FDA approval; (2) statutes containing a presumption against liability based on compliance with governmental regulations; (3) statutes containing a bar to punitive damages based on FDA approval; and (4) statutes containing a bar to punitive damages based on compliance with governmental regulations.2

PRESUMPTION AGAINST LIABILITY DUE TO FDA APPROVAL

Michigan: “In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States Food and Drug Administration, and the drug and its labeling were in compliance with the United States Food and Drug Administration’s approval at the time the drug left the control of the manufacturer or seller.”

MCL § 600.2946(5)

New Jersey: “If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the Federal Food and Drug Administration under the [FDCA] or [Public Health Service Act] a rebuttable presumption shall arise that the warning or instruction is adequate.”

N.J.S.A. § 2A:58C-4.

Texas: “[T]here is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable with respect to the allegations involving failure to provide adequate warnings or information if:

(1) the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the [FDCA] or [Public Health Service Act]; or

(2) the warnings provided were those stated in monographs developed by the United States Food and Drug Administration for pharmaceutical products that may be distributed without an approved new drug application.”

Tex. Civ. P. & Rem. § 82.007(a).

PRESUMPTION AGAINST LIABILITY DUE TO COMPLIANCE WITH GOVERNMENT REGULATIONS

Federal: Applies to vaccine warnings only, providing that “a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the [FDCA and the Vaccine Act] applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought.” 42 U.S.C. § 300aa-22(b)(2)

Colorado: “In any product liability action, it shall be rebuttably presumed that the product which caused the injury, death, or property damage was not defective and that the manufacturer or seller thereof was not negligent if the product:

. . .

(b) Complied with, at the time of sale by the manufacturer, any applicable code, standard, or regulation adopted or promulgated by the United States or by this state, or by any agency of the United States or of this state.”

C.R.S.A. § 13-21-403(1).

Florida: The statute creates a rebuttable presumption that a product is not defective or unreasonably dangerous “if, at the time the specific unit of the product was sold . . .the aspect of the product that allegedly caused the harm:

a) complied with federal or state codes, statutes, rules, regulations, or standards relevant to the event causing the death or injury;

b) the codes, . . . are designed to prevent the type of harm that allegedly occurred; and c) compliance with the codes, . . . is required as a condition for selling or distributing the product.

Fla. St. Ann. § 768.1256.

Indiana: “[T]here is a rebuttable presumption that the product that caused the physical harm was not defective and that the manufacturer or seller of the product was not negligent if, before the sale by the manufacturer, the product:

. . .

(2) complied with applicable codes, standards, regulations, or specifications established, adopted, promulgated, or approved by the United States or by Indiana, or by an agency of the United States or Indiana.”

IC § 34-20-5-1.

Kansas: “When the injury-causing aspect of the product was, at the time of manufacture, in compliance with legislative regulatory standards or administrative regulatory safety standards relating to design or performance, the product shall be deemed not defective by reason of design or performance, or, if the standard addressed warnings or instructions, the product shall be deemed not defective by reason of warnings or instructions, unless the claimant proves by a preponderance of the evidence that a reasonably prudent product seller could and would have taken additional precautions.”

Kan. Stat. Ann. § 60-3304.

North Dakota: “There is a rebuttable presumption that a product is free from any defect or defective condition if the plans, designs, warnings, or instructions for the product or the methods and techniques of manufacturing, inspecting, and testing the product were in conformity with government standards established for that industry or if no government standards exist then with applicable industry standards, which were in existence at the time the plans, designs, warnings, or instructions for the product or the methods and techniques of manufacturing, inspecting, and testing the product were adopted.”

N.D. Cent. Code, § 28-01.3-09

Tennessee: “Compliance by a manufacturer or seller with any federal or state statute or administrative regulation existing at the time a product was manufactured and prescribing standards for design, inspection, testing, manufacture, labeling, warning or instructions for use of a product, shall raise a rebuttable presumption that the product is not in an unreasonably dangerous condition in regard to matters covered by these standards.”

Tenn. Code Ann. § 29-28-104(a)

Texas: “There is a rebuttable presumption that the product manufacturer or seller is not liable for any injury to a claimant caused by some aspect of the formulation, labeling, or design of a product if the product manufacturer or seller establishes that the product’s formula, labeling, or design complied with mandatory safety standards or regulations adopted and promulgated by the federal government, or an agency of the federal government, that were applicable to the product at the time of manufacture and that governed the product risk that allegedly caused harm . . . [or] if the product manufacturer or seller establishes that the product was subject to pre-market licensing or approval by the federal government, or an agency of the federal government, that the manufacturer complied with all of the government’s or agency’s procedures and requirements with respect to pre-market licensing or approval, and that after full consideration of the product’s risks and benefits the product was approved or licensed for sale by the government or agency.”

Tex. Civ. P. & Rem. § 82.008.

Utah: “There is a rebuttable presumption that a product is free from any defect or defective condition where the alleged defect in the plans or designs for the product or the methods and techniques of manufacturing, inspecting and testing the product were in conformity with government standards established for that industry which were in existence at the time the plans or designs for the product or the methods and techniques of manufacturing, inspecting and testing the product were adopted.”

Utah Code Ann. § 78B-6-703(2).

Wisconsin: “Evidence that the product, at the time of sale, complied in material respects with relevant standards, conditions, or specifications adopted or approved by a federal or state law or agency shall create a rebuttable presumption that the product is not defective.”

Wis. Stat. § 895-.047(3)(b)

PUNITIVE DAMAGES BAR DUE TO FDA APPROVAL

Arizona: Drug-specific:

“The manufacturer or seller of a drug is not liable for exemplary or punitive damages if the drug alleged to cause the harm either:

1. Was manufactured and labeled in relevant and material respects in accordance with the terms of an approval or license issued by the Federal Food and Drug Administration under the Food, Drug and Cosmetic Act (21 United States Code section 301, et seq.) or the Public Health Service Act (42 United States Code section 201, et seq.) or

2. Is generally recognized as safe and effective pursuant to conditions established by the Federal Food and Drug Administration and applicable regulations, including packaging and labeling regulations.”

Ariz. Rev. Stat. § 12-701.

Generally:

“A manufacturer, service provider or seller is not liable for exemplary or punitive damages if any of the following applies:

1. The product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.

2. The product, activity or service complied with all statutes of this state or the United States or standards, rules, regulations, orders or other actions of a government agency pursuant to statutory authority that are relevant and material to the event or risk allegedly causing the harm and the product, activity or service complied at the time the product left the control of the manufacturer or seller.”

Ariz. Rev. Stat. § 12-689.

New Jersey: “Punitive damages shall not be awarded if a drug or device or food or food additive which caused the claimant’s harm was subject to premarket approval or licensure by the Federal Food and Drug Administration under the [FDCA] or [Public Health Service Act] and was approved or licensed; or is generally recognized as safe and effective pursuant to conditions established by the Federal Food and Drug Administration and applicable regulations, including packaging and labeling regulations.”

N.J.S.A. § 2A:58C-5

Ohio: “[I]f a claimant alleges in a product liability claim that a drug or device caused harm to the claimant, the manufacturer of the drug or device shall not be liable for punitive or exemplary damages in connection with that product liability claim if the drug or device that allegedly caused the harm satisfies either of the following:

(a) It was manufactured and labeled in relevant and material respects in accordance with the terms of an approval or license issued by the Federal Food and Drug Administration under the [FDCA] or [Public Health Service Act].

(b) It was an over-the-counter drug marketed pursuant to federal regulations, was generally recognized as safe and effective and as not being misbranded pursuant to the applicable federal regulations, and satisfied in relevant and material respects each of the conditions contained in the applicable regulations and each of the conditions contained in an applicable monograph.”

Ohio Rev. Code Ann. § 2307.80(c)(1).

Oregon: “[T]he manufacturer of the drug shall not be liable for punitive damages if the drug product alleged to have caused the harm:

(a) Was manufactured and labeled in relevant and material respects in accordance with the terms of an approval or license issued by the Federal Food and Drug Administration under the [FDCA] or the Public Health Service Act; or

(b) Is generally recognized as safe and effective pursuant to conditions established by the Federal Food and Drug Administration and applicable regulations, including packaging and labeling regulations.”

Or. R.S. § 30.927(a).

Utah: “Punitive damages may not be awarded if a drug causing the claimant’s harm:

(a) received premarket approval or licensure by the Federal Food and Drug Administration under the [FDCA] or [Public Health Service Act];

(b) is generally recognized as safe and effective under conditions established by the Federal Food and Drug Administration and applicable regulations, including packaging and labeling regulations.”

Utah Code Ann. § 78B-8-203

PUNITIVE DAMAGES BAR DUE TO COMPLIANCE WITH GOVERNMENT REGULATION

North Dakota: “Exemplary damages may not be awarded against a manufacturer or seller if the product’s manufacture, design, formulation, inspection, testing, packaging, labeling, and warning complied with:

a. Federal statutes existing at the time the product was produced;

b. Administrative regulations existing at the time the product was produced that were adopted by an agency of the federal government which had responsibility to regulate the safety of the product or to establish safety standards for the product pursuant to a federal statute; or

c. Premarket approval or certification by an agency of the federal government.”

N.D. Cent. Code, § 32-03.2-11(6)

Tennessee: “A manufacturer or seller, other than a manufacturer of a drug or device, shall not be liable for exemplary or punitive damages if:

(1) The product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold, or represented in relevant and material respects in accordance with the terms of approval, license or similar determination of a government agency; or

(2) The product was in compliance with a statute of the state or the United States, or a standard, rule, regulation, order, or other action of a government agency pursuant to statutory authority, when such statute or agency action is relevant to the event or risk allegedly causing the harm and the product was in compliance at the time the product left the control of the manufacturer or seller.”

Tenn. Code Ann. § 29-28-104(b)


[1] As in, adhering to current industry standards.

[2] This article does not address the various statutory exceptions to these compliance defenses. Some of these statutes contain exceptions if, for example, fraud has been committed by the FDA. In turn, some of those exceptions have been found preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). For instance, in Lofton v. McNeil Consumer & Specialty Pharms., the Fifth Circuit held that a fraud on the FDA exception in the Texas statute was preempted by federal law. 672 F.3d 372, 381 (5th Cir. 2012); see also Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) (same under Michigan statute); McDarby v. Merck, 401 N.J. Super. 10 (N.J. App. Div. 2008) (same under New Jersey statute).

Finis

Citations

  1. As in, adhering to current industry standards. Jump back to footnote 1 in the text
  2. This article does not address the various statutory exceptions to these compliance defenses. Some of these statutes contain exceptions if, for example, fraud has been committed by the FDA. In turn, some of those exceptions have been found preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). For instance, in Lofton v. McNeil Consumer & Specialty Pharms., the Fifth Circuit held that a fraud on the FDA exception in the Texas statute was preempted by federal law. 672 F.3d 372, 381 (5th Cir. 2012); see also Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) (same under Michigan statute); McDarby v. Merck, 401 N.J. Super. 10 (N.J. App. Div. 2008) (same under New Jersey statute). Jump back to footnote 2 in the text