Whenever we examine “right to try” (“RTT”) legislation, on either the state or federal level, one of the most important things we look at is whether the would-be statute provides immunity from civil litigation to our clients – the companies that invent and manufacture the potentially life-saving products that are at issue. Since none of these RTT bills has ever purported to force manufacturer participation, immunity is not surprisingly central to have any chance of obtaining their voluntary consent.

This isn’t merely an abstract consideration.

While most persons receiving access to investigational drugs via a RTT program undoubtedly would be thankful for the assistance, even if the treatment did not succeed, all it takes is one ingrate with a lawyer to ruin things for everybody.  That’s precisely the scenario that occurred in Ward v. Schaefer, 2017 WL 5505405 (D. Mass. Nov. 16, 2017), except that the plaintiff was also his own lawyer.  While Ward did not involve RTT (Massachusetts has no such statute), the plaintiff sued over an experimental drug provided under the FDA’s “compassionate use” program, which is essentially RTT without the right-wing, anti-federal government overlay.  Indeed, Ward may well be the reason that the current federal RTT bill also extends its immunity provisions to cover FDA-supervised compassionate use.

The plaintiff in Ward had a rare genetic condition that caused severe health problems.  Plaintiff sued everybody – the drug manufacturer, a successor company, and the government officers (National Institutes of Health) who were involved in the treatment protocol.  Ward, 2017 WL 5505405, at *4.  Rather than compassionate use, plaintiff complained that defendants were really after pecuniary gain:

The complaint alleges that the four individuals induced [plaintiff] to participate as the only subject in a long-term trial of [the drug] by misrepresenting that the drug would reverse his [condition].  According to the complaint, they withheld their true motivation for the study, which was to test the effect of [the drug] . . . “hoping the drug would be considered a potential breakthrough in the prevention of cardiovascular disease,” as well as to acquire long-term safety data, in order to accelerate the sale of [the manufacturer] to . . . a large pharmaceutical company.

Id. at *2.

The “large pharmaceutical company” successfully had the allegations against it dismissed for failure to state a claim.  Ward v. Auerbach, 2017 WL 2724938, at *8 (D. Mass. June 23, 2017) (“mere knowledge of [defendant’s] treatment − which is all that is alleged in the complaint − is not sufficient to impose liability for any fraud alleged to have induced him to participate in the clinical trial nor any harm caused by the trial”).  Plaintiff failed to establish personal jurisdiction against the manufacturer of the drug.  Id. at *10-13.  Compassionate use programs did not confer immunity.  That defense was never an issue in Ward.

The specific legal ruling in Ward substituted the United States government as an entity for the individual plaintiffs.  2017 WL 5505405, at *5-6.  That hardly matters from our perspective.  To us, the entire Ward litigation demonstrates that our concerns about possible manufacturer liability when unproven investigational drugs are being dispensed outside of the established clinical trial framework are quite valid.  It wouldn’t take many suits like Ward to convince drug manufacturers that, simply to avoid litigation expense, they should have nothing to do with compassionate use or RTT.  Ward lasted for the better part of two years, produced five opinions, and at least one appeal.

The remainder of the litigation, against the United States government for the alleged involvement of federal employees in administering plaintiff’s compassionate use protocol, was ultimately dismissed a couple of months ago on grounds of sovereign immunity.  See Ward v. Schaefer, 2018 WL 1096829, at *6 (D. Mass. Feb. 27, 2018).  In any event, Ward is a stark reminder that litigants will sue over anything, even the most benignly intended programs like compassionate use/RTT if they think there’s a buck to be made in damages.  Thus, immunity from suit is a critical factor to inducing the voluntary manufacturer participation without which these programs cannot possibly succeed.

For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets constitutional requirements.  Instead, it seems bent on distracting the public from its abject failures with empty gestures.

Thus, we saw in Law 360 the other day that the legislature has passed, and the governor has agreed to sign, “right to try” legislation.  As we’ve discussed before, right to try legislation purports to make it easier for terminally ill patients to obtain access to drugs (and other FDA-regulated products) that have not completed the FDA’s long and arduous approval process.  In fact, we have seen no evidence that such legislation has ever actually helped anyone.  State right to try legislation has been ineffective chiefly for three reasons:  (1) it is federally preempted by the FDA’s compassionate use program, (2) manufacturers are unlikely to opt into these purely voluntary programs because any adverse events involving what would be a very sick patient population would have to be reported to the FDA and thus could jeopardize eventual approval, and (3) the legislation does not adequately protect manufacturers from potential liability for allowing the use of unapproved drugs.  Why do we care?  Because we worry about terminally ill patients suing manufacturers to force them to provide investigational drugs, which has been unsuccessfully tried in the past, and might be tried again in the future.

Obviously, no state legislation can do anything about problems #1 or 2, because those are matters governed by federal law that would require a federal statute.  As for problem #3, states have immunized manufacturers from state-law liability to a greater or lesser extent, so what about Pennsylvania?

Here’s a link to the text (as amended) of the current bill, HB45.

While there’s a section devoted to “health care provider immunity” (§5(a)), the potential liability of the entities that actually manufacture the investigational drugs (and other products) in question is only addressed in the section (§6) involving “construction” of the statute. That section provides – with unnecessary verbosity removed for clarity:

Nothing in this act may be construed as creating a private cause of action against a manufacturer of an investigational drug, biological product or medical device . . . for any injury suffered by the eligible patient resulting from the investigational drug, biological product or medical device, as long as the manufacturer . . . acted in accordance with this act, except when the injury results from a failure to exercise reasonable care.

(Emphasis added).

Pathetic. Probably worse than nothing. This section says zilch about liability under existing common-law theories – only about “creating” a new “private cause of action.”  Nor does it even preclude a new, private statutory cause of action.  To the contrary, it allows one, only it must be based on negligence (“failure to exercise reasonable care”).  As we’ve pointed out before, negligence is already the existing basis for Pennsylvania product liability for prescription medical products. See, e.g., Hahn v. Richter, 673 A.2d 888, 889 (Pa. 1996) (another case Bexis worked on way back when).  Thus, the Pennsylvania Right To Try legislation provides no additional protection to participating manufacturers at all – even those who complied with the statute – instead it appears to allow an additional, redundant negligence-based private statutory cause of action.

That being the case, there is no incentive whatsoever for any FDA regulated manufacturer to participate in the putative Pennsylvania Right To Try program, and every reason for them to refrain from doing so.  Rather, it’s an empty gesture – intended to distract the public from the legislature’s inability to perform its most basic constitutional duties.

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.