We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second, drugmakers aren’t likely to distribute experimental drugs due to liability concerns, and these statutes don’t go far enough in removing that threat. Third, such statutes interfere with drug development because they involve the inclusion of people who don’t meet study criteria – often because they are too sick – which is likely to increase the number of adverse results, all of which must be reported to FDA.
Apparently the number of states with Right To Try statutes is up to 37 – but we have yet to learn of a single individual that has successfully utilized any of them. For the reasons we’ve stated before, we’re not surprised.
But earlier this month, the United States Senate just passed (apparently by voice ) a reworked version of the “Trickett Wendler Right to Try Act” (S. 4788) that we discussed in our prior post. A federal act would, of course, obviate the preemption problem, or at least replace it with issues of reconciling two federal statutes – which would be a somewhat less daunting a challenge.
Because of that senate action, we’re taking another look at the proposed legislation, a link to which is here. First, it applies to anyone “with a life-threatening disease or condition” “who has exhausted approved treatment options and is unable to participate in a clinical trial.” §561B(a)(1)(A-B). Eligibility must be “certified” by a treating physician who “will not be compensated directly by the manufacturer for so certifying.” Id. §561B(a)(1)(B).
The “investigational drugs” that the legislation would make available must have completed a preliminary “Phase 1 clinical trial” and must be under active “investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of approval or licensure.” Id. §561B(a)(1)(C). Essentially S.4789 seeks to open up to terminal patients access to any unapproved drugs under current investigation, provided they have passed the relatively basic threshold Phase I determinations that they aren’t acutely toxic to humans and might have some plausible benefit. Phase I investigations:
are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.
21 C.F.R. §312.21(a). Phase 1 studies are small, with between “20 to 80” study participants. Id.
Getting down to litigation-related brass tacks, S.4789 contains a subsection, §561B(something) (b) – we’re frankly not sure of the numbering – entitled “no liability,” that would provide as follows:
(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 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.
Meh. We’re not impressed.
We consider this language a significant step backwards from the non-liability language of the 2016 version (S.2912) of this legislation that we reviewed here. That language would have provided that compliance with the act allowed “no liability” “[n]otwithstanding any other provision of law.” The current language of S.4789 would allow liability – despite “compliance” – as long as a plaintiff could allege “reckless or willful misconduct, gross negligence, or an intentional tort.” That’s not much protection at all, given how readily the other side throws around such allegations, and how infrequently judges throw them out. In subsection 1, “Reckless/willful” is a standard for punitive damages, which routinely survive dismissal in MDLs and other actions around the country. “Gross negligence” is a standard even less than that – merely an aggravated form of negligence that doesn’t require any finding of intent at all. Intentional torts include fraud, which is currently included in just about any product liability complaint. Battery, which encompasses informed consent in many states, is also an intentional tort.
In short, the heading “no liability” is itself misleading. Manufacturers complying with S.4789 would be risking plenty of potential liability in today’s litigation-addicted society. Underscoring the lack of protection that this section provides to participating parties, subsection 3 further specifies that, outside of subsections 1 and 2, no protection at all from civil liability is created by this bill.
Subsection 2 is a lot more absolute: “No liability” lies against anybody for a “determination not to provide access.” In light of the wholly inadequate immunity language in Part 1 of the “no liability” section of S.4789, it becomes difficult to recommend to a nervous client anything other than the conduct that would bring the absolute non-liability of subsection 2 into play. Manufacturers stand to gain nothing by participating in this postulated federal Right To Try program – it’s not even clear if they can charge anybody for the cost of the investigational drugs in question – so don’t expect them to them to gravitate to something with the potential to open up new liability for the provision of untried, incompletely tested, investigational drugs. The Swiss-cheese liability shield of S.4789, by itself, is an invitation to failure.
The legislation’s approach to the reporting of adverse events to the FDA is better, but nevertheless still comes with a significant caveat:
Notwithstanding any other provision of . . . Federal law, the Secretary may not use a clinical outcome associated with the use of an eligible investigational drug pursuant to this section to delay or adversely affect the review or approval of such drug . . . unless—
(A) the Secretary makes a determination, in accordance with paragraph (2), that use of such clinical outcome is critical to determining the safety of the eligible investigational drug; or
(B) the sponsor requests use of such outcomes.
Think that the “unless” won’t happen? We’re hardly sanguine. Remember, the FDA was once run by the likes of current-plaintiff-expert David Kessler. Consider the gyrations that the FDA has gone through, first to create and for the last couple of decades to justify, its ban on truthful speech regarding off-label uses. If there has ever been an agency more likely than the FDA to use its discretionary authority to “hide elephants in mouseholes,” Gonzales v. Oregon, 546 U.S. 243, 267 (2006) (citing, inter alia, FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 160 (2000)), we haven’t encountered it. The bill contains no definition of “critical”; its only limit on the “unless” exception is that be in writing and made “part of the administrative record” by the FDA commissioner. §561B(c)(2).
All in all, we are disappointed with the current version of the federal Right To Try statute. For all the aspersions that the other side likes to heap on this Congress as being “pro-business,” this version of Trickett Wendler is less pro-business, and more plaintiff friendly, than the 2016 version that was written by a Senate controlled by Democrats. If passed, we doubt that it would be any more effective than the current hodge-podge of state Right To Try statutes in saving the lives of terminally ill patients.