References in Text
The Public Health Service Act, referred to in subsec. (c)(1), is [act July 1, 1944, ch. 373], [58 Stat. 682], which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.
Limitation of Liability
[Pub. L. 115–176, § 2(b)], May 30, 2018, [132 Stat. 1374], provided that:“(1)
Alleged acts or omissions.—
With respect to any alleged act or omission with respect to an eligible investigational drug provided to an eligible patient pursuant to section 561B of the Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 360bbb–0a] and in compliance with such section, no liability in a cause of action shall lie against—
“(A)
a sponsor or manufacturer; or
“(B)
a prescriber, dispenser, or other individual entity (other than a sponsor or manufacturer), unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law.
“(2)
Determination not to provide drug.—
No liability shall lie against a sponsor manufacturer, prescriber, dispenser or other individual entity for its determination not to provide access to an eligible investigational drug under section 561B of the Federal Food, Drug, and Cosmetic Act.
“(3)
Limitation.—
Except as set forth in paragraphs (1) and (2), nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action under any State or Federal product liability, tort, consumer protection, or warranty law.”