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Our first reaction to Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014), wasn’t related to the fact that it involved a federal court recognizing a cause of action previously unrecognized by Massachusetts state courts.  Our first reaction was that the case shouldn’t be complicated.  The plaintiff participated in a clinical trial involving a bilateral gene transfer, which is a new procedure intended to treat Young-Onset Parkinson’s Disease.  Id. at *3.  As the “bilateral” in its name implies, a bilateral gene transfer consists of two injections of genes into the brain, one into the right side and one into the left.  Id. at *3-4.  But (plaintiff alleged) the surgeon gave both injections to the left side.  Id. at *4.

It seems fairly easy to identify the problem here.  If an engineer designs a twin-engine plane, and the mechanics put both engines on the left side, you’ve got a good idea who made the mistake.  If the Doublemint gum company told its casting director to hire blond twins for its commercial, and the casting director hired some guy named Roy, you can be pretty sure who made that mistake too.  So whom did the Zeman plaintiffs sue over the improper procedure?  The manufacturer and the Institutional Review Board (“IRB”), of course.

But we won’t fixate on the choice of defendants.  We have no doubt that the decision involved a good deal of pragmatism.  We’ll focus instead on plaintiffs’ claims against those defendants.  As to the IRB, plaintiffs claimed that it negligently drafted and approved the patient’s informed consent form.  Over the years, though, Massachusetts’s informed consent doctrine has developed in malpractice actions involving a patient’s primary medical provider, and the Supreme Judicial Court of Massachusetts has refused to expand the doctrine’s reach to also include medical professionals who provided limited or tangential treatment to the patient.  Id. at *13-14.  The Zeman court understood this, noting that the IRB stood “outside the treatment relationship” with patients, and it dismissed the claim.  Id. at *13.  That was a sensible application of established Massachusetts law.  As to the manufacturer, the court dismissed plaintiffs’ breach of warranty and negligent defect claims because plaintiffs alleged no specific facts.  Id. at *11-13.  That’s a sensible application of TwIqbal.

But we didn’t find the court’s decision on plaintiffs’ informed consent claim against the manufacturer to be as sensible.  In that claim, plaintiffs argued that manufacturers had a duty that ran directly to clinical trial patients to draft and approve a consent form that ensured patient safety.  Id. at *6.  The court agreed.  Yet there were multiple caution flags suggesting that the federal court follow the Erie doctrine, exercise restraint and not expand state law.  Most important, Massachusetts state courts had never actually recognized such a claim.  Id. at *9.  Also, the Massachusetts Supreme Judicial Court, as mentioned earlier, has been cautious about expanding the informed consent doctrine beyond a patient’s primary medical providers.  And Massachusetts follows the learned intermediary doctrine, meaning that under ordinary circumstances a manufacturer’s duty to warn runs to the treating doctor, not the patient.  Even the federal court itself, in discussing a potential direct duty to a clinical trial patient, seemed unsure, using phases such as “may be owed” and “[i]t is plausible.”  Id. at *8-9.  All this, we believe, points toward restraint, not expansion of state law.  The court, unfortunately, ultimately saw it otherwise.

That said, we still think this can be an easy case and may turn on a bilateral process being applied, well, unilaterally.  We’ll follow this one.