An Act relating to ethylene oxide emissions; creating an exclusive cause of action for ethylene oxide exposure actions; providing that a plaintiff may prevail in an ethylene oxide exposure action only in accordance with the requirements of this Act.

Section 1. Requirements for Liability for Exposure to Ethylene Oxide

Notwithstanding any other provision of law, and except as otherwise provided in this section, no individual or entity engaged in businesses in the healthcare industry, including the manufacturing, sales and distribution, sterilization, storage, and transportation of medical devices, shall be liable in any ethylene oxide exposure action unless the plaintiff can prove by clear and convincing evidence that:

(A) in engaging in the businesses, the individual or entity was not in substantial compliance and was not making reasonable efforts in light of all the circumstances to be in substantial compliance with the applicable United States government laws, regulations, or standards related to ethylene oxide in effect at the time of the actual, alleged, feared, or potential for exposure to ethylene oxide;

(B) the individual or entity engaged in gross negligence or willful misconduct that caused an actual exposure to ethylene oxide; and

(C) the actual exposure to ethylene oxide was the direct and proximate cause of the personal injury of the plaintiff.

Section 2. Procedures for Claims of Liability for Exposure to Ethylene Oxide

(A) PLEADING WITH PARTICULARITY. In any ethylene oxide-related action the complaint shall plead with particularity:

(1) each element of the plaintiff’s claim; and

(2) the complaint shall plead with particularity each alleged act or omission constituting gross negligence or willful misconduct that resulted in personal injury, harm, damage, breach, or tort.

(B) NATURE AND AMOUNT OF DAMAGES. In any ethylene oxide-related action in which monetary damages are requested, there shall be filed with the complaint a statement of specific information as to the nature and amount of each element of damages and the factual basis for the damages calculation.

(C) REQUIRED STATE OF MIND. In any ethylene oxide-related action in which a claim is asserted on which the plaintiff may prevail only on proof that the defendant acted with a particular state of mind, there shall be filed with the complaint, with respect to each element of that claim, a statement of the facts giving rise to a strong inference that the defendant acted with the required state of mind.

Section 3. Application and Preemption

(A) IN GENERAL. This Act creates an exclusive cause of action for ethylene oxide exposure actions.

(B) LIABILITY. A plaintiff may prevail in an ethylene oxide exposure action only in accordance with the requirements of this Act.

(C) APPLICATION. — The provisions of this subtitle shall apply to:

(1) any cause of action that is a ethylene oxide exposure action that was filed before the date of enactment of this Act and that is pending on such date of enactment; and

(2) any ethylene oxide exposure action filed on or after such date of enactment.

(D) Preemption And Supersedure. This subtitle preempts and supersedes any State law, including statutes, regulations, rules, or standards that are enacted, promulgated, or established under common law, related to recovery for personal injuries caused by actual, alleged, feared, or potential for exposure to ethylene oxide.

(E) WORKERS’ COMPENSATION LAWS NOT PREEMPTED OR SUPERSEDED. Nothing in this subtitle shall be construed to affect the applicability of any State law providing for a workers’ compensation scheme or program, or to preempt or supersede an exclusive remedy or defense under such scheme or program.