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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.