For those closely following the litigation over this clinical trial, a few updates. On January 22, the district court ruled on defendants’ motions to dismiss plaintiffs’ third amended complaint. That complaint named as defendants the director of the IRB, the chair of the IRB, the other members of the IRB (“the IRB defendants”)—all in their individual capacities; the PI of the trial, in his individual capacity; Masimo Corporation, the manufacturer of the oximeter used in the trial; and fictitious defendants (ABC Health Care Providers #1-100; ABC Individuals #1-100; and XYZ Entities #1-100). The complaint stated seven counts: products liability and negligence against Masimo; negligence, negligence per se, lack of informed consent, and breach of fiduciary duty against the IRB defendants and the PI; and wrongful death against all defendants.
Per the federal system’s tendency, the court dismissed from the suit the non-specific fictitious defendants. The court also dismissed, with prejudice and as time barred, the wrongful death count brought against all defendants. (For the same reason, the court denied as futile plaintiffs’ request for leave to amend the complaint to state a claim for loss of consortium.)
The court, however, denied Masimo’s motion to dismiss the state products liability and negligence claims against it for allegedly “rigg[ing] the oximeter so that it would not reveal the actual oxygen level, and would not sound an alert when levels were too low or too high.” The court rejected Masimo’s argument that, under Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341 (2001), these claims were impliedly preempted by FDA medical device regulations, and it found that plaintiffs had properly pled their state manufacturing defect and negligence claims against Masimo.
Having dismissed the wrongful death count against all defendants and declining to dismiss any counts directed solely against Masimo, the court denied without prejudice the remaining four counts brought against the IRB defendants and the PI—negligence, negligence per se, lack of informed consent, and breach of fiduciary duty—for failure to meet basic federal pleading requirements. Plaintiffs had pled each of these four counts against “all defendants except Masimo,” and the court agreed with defendants that doing so deprived individual defendants of fair notice as to exactly what wrongful conduct each of them is being accused of: “The claims challenge individual actions and decisions that cannot simply be imputed to a group without pleading some facts as to ‘who did what.'”
Moreover, the court noted that, insofar as the negligence count against “all defendants except Masimo” involves allegations related to “the treatment, care, monitoring, observing, discovering, and diagnosis of the Plaintiffs,” it is a medical malpractice claim subject to the heightened pleading requirements of the Alabama Medical Liability Act (AMLA). In particular, the court pointed to the following allegations:
- Failing to properly and adequately treat and care for the Plaintiffs’ and the Class’ condition;
- Caring for the Plaintiffs and the members of the Class in a negligent and improper manner;
- Failing to properly monitor the condition of the Plaintiffs and the members of the Class;
- Failing to properly and timely observe, discover, diagnose, treat, and care for their condition;
The court found plaintiffs’ pleading as to these allegations especially lacking, as they failed to provide details regarding, e.g., “when, how, or by whom the infants were treated.”
The court also suggested, without deciding, that the informed consent allegations, too, are “potentially” medical malpractice claims under the AMLA, although the court noted that lack of informed consent claims in the clinical trial context are an issue of first impression in Alabama and that it was “not convinced that the two contexts for an informed consent claim,” i.e., clinical research and clinical care, “are the same.” In any event, the court noted that even if the informed consent claims are not medical malpractice claims, “the way in which Plaintiffs have framed the allegations is also very close to fraud,” which is also subject to heightened pleading requirements.
The court, however, gave plaintiffs “one more opportunity” to amend their complaint to cure the pleading errors in these four counts against the IRB defendants and the PI, and warned plaintiffs to “take special care when pleading the specific, malpractice-type claims from the complaint.”
In response, plaintiffs filed their fourth amended complaint on January 31 (ahead of the court’s February 5 deadline). A quick skim (alas, all I have time for today; but I’ve uploaded the documents to scribd for those who want to do a deep dive) suggests that plaintiffs: (1) cured the most glaring pleading defect by pleading against individual defendants, rather than against “all defendants excepts Masimo”; and (2) responded to the court’s admonition about the heightened pleading requirements for the “malpractice-type” claims (listed above) by omitting them.
Onward to summary judgment, I’d guess. (Incidentally, in its opinion, the court also addressed various immunity defenses by the defendants, rejecting some and declining to fully consider others until the summary judgment stage.)
One final thing of note: Plaintiffs allege that the IRB members were charged with “[e]nsuring that the Experiment was an ethical one where risks did not exceed benefits” (emphasis mine). Of course, that’s not what the Common Rule requires. If it did, plaintiffs’ argument that the SUPPORT trial improperly posed foreseeable risks to subjects that they would not otherwise have faced as premature newborns would be vulnerable to the response that even serious risks of death and permanent disability to (let us assume, arguendo) all 1,300 subject infants were in fact exceeded by the benefits to a virtually infinite number of future babies of a trial that allowed us finally to know the ideal oximeter level to be used in order to minimize incidence of death and disability in this population.
True, we could read research risk-benefit analysis as requiring risks to subjects not to exceed benefits to subjects (without any consideration of reasonably expected social benefits of a protocol), but that would collapse research risk-benefit analysis into the best interests standard of clinical practice — and, given OHRP’s extremely narrow interpretation of what counts as a research “benefit” to subjects and its capacious understanding of research “risk,” render most research impermissible.
As for what 45 C.F.R. § 46.111 expects IRBs to do when it requires them to find, not that risks do not “exceed” benefits but, rather, that
[r]isks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result
(emphasis added)? Got me.