One aspect of Pietrantoni v. Corcept Therapeutics Inc., ___ F. Supp.3d ___, 2022 WL 16857262 (D. Mass. Nov. 10, 2022), has troubled us ever since we first noticed the opinion.  But we recently noticed that Pietrantoni had been selected for publication, so we decided the issue was important enough to examine in depth.

In a lot of ways Pietrantoni is a pretty good case for the defendants.  The plaintiffs’ attacks on the drug’s design and warnings were both preempted – the design claim because it demanded a “major change” that would require FDA prior approval, and the warning claim because there was no “newly acquired information” that would have supported the defendant unilaterally changing its warning in the manner plaintiff advocated.  2022 WL 16857262, at *8 (design claim), *11-15 (warning claim).  The warning discussion is particularly valuable for its discussion of the lack of anything new or different in adverse event reports concerning the drug.

But the unusual aspect of Pietrantoni, and the reason it attracted our attention, was the plaintiff being allowed to assert a claim for negligent medical monitoring.  Id. at *16-17.  This is not a medical monitoring claim based on lack of any present injury – there was no dispute that the plaintiff had alleged present physical injury.  Id. at *8.  Rather, the negligent monitoring claim that survived was based on the alleged actions (or inactions) of “Patient Care Advocates” (“PCAs”) that the defendant manufacturer allegedly made available to plaintiff when the drug was prescribed:

[Defendant] assigned [plaintiff] “Patient Care Advocates” who, [defendant] informed, would monitor her health condition in light of taking [the drug].  The Patient Care Advocates were to work with [plaintiff] and [co-defendant pharmacy] through [a] Support Program. . . .  In [plaintiff’s] first three to four months on [the drug], she and [her] Patient Care Advocate[] communicated twice per month, but communication later became less frequent.

Id. at *8 (complaint citations omitted).  When plaintiff reported symptoms of what ultimately became a serious injury, however, nothing supposedly happened.  Allegedly, the two PCAs with whom plaintiff communicated “did not instruct her to seek medical care . . . or to discontinue use” of the drug.  Id., see id. (“neither [PCA] ever instructed [plaintiff] to seek medical care for . . ., to stop taking [the drug], or to have an ultrasound”) (complaint citations omitted).

Those allegations, Pietrantoni held, sufficed to state an unpreempted (because the PAC program was apparently not FDA required) claim for negligent performance of a voluntarily assumed duty.  Id. at *17.  Pietrantoni relied on two Massachusetts Supreme Judicial Court decisions that followed Restatement (Second) of Torts §323 (1965):  Thorson v. Mandell, 525 N.E.2d 375, 378 (Mass. 1988), and Cottam v. CVS Pharmacy, 764 N.E.2d 814, 821 (Mass. 2002).  2022 WL 16857262, at *17.  In a brief discussion, Pietrantoni held that plaintiff stated a claim for negligent voluntary undertaking:

[Plaintiff] has plausibly pled that [defendant], by assigning her “Patient Care Advocates” to monitor her health on [the drug] voluntarily assumed such a duty. . . .  Additionally, [plaintiff] has satisfied the remaining elements of negligence − breach, causation, and damages − in stating that her [PCAs] did not instruct her to seek medical care when [her symptoms occurred], causing her to continue using [the drug] and ultimately to sustain [serious] injuries.

Id. (citations omitted).

That discussion was too brief, and illustrates a common misconception about the voluntary assumption doctrine stated in Restatement §323 – simply alleging the negligent performance of a voluntarily assumed activity is not enough.  The black letter of §323 provides:

One who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of the other’s person or things, is subject to liability to the other for physical harm resulting from his failure to exercise reasonable care to perform his undertaking, if

(a) his failure to exercise such care increases the risk of such harm, or

(b) the harm is suffered because of the other’s reliance upon the undertaking.

Restatement §323 (emphasis added).

Thus to allege negligent undertaking liability under §323, it is insufficient just to allege the existence of an undertaking, and that it was negligently performed.  No, a plaintiff must also allege increased risk or reliance – and there is not a word of either in Pietrantoni.  That’s because, as the First Circuit put it, “[t]he test is not whether the risk was increased over what it would have been if the defendant had not been negligent,’ but rather whether the risk was increased over what it would have been had the defendant not engaged in the undertaking at all.”  Thames Shipyard & Repair Co. v. United States, 350 F.3d 247, 261 (1st Cir. 2003) (internal quotations omitted) (emphasis added).  The plaintiff in a negligent undertaking case must “be placed in a worse position than if the [defendant] had not intervened.”  Payton v. Abbott Labs, 9, 437 N.E.2d 171, 182 (Mass. 1982) (quoting Restatement § 323, comment c).  A defendant’s “failure to inspect . . . may not have diminished a risk that could have been diminished, but it did not increase the risk of that harm.”  Smith v. Robertshaw Controls Co., 410 F.3d 29, 38 (1st Cir. 2005) (emphasis original).

The defendant’s negligent performance must somehow put the plaintiff in a worse situation than if the defendant had never begun the performance.  Compare cases referring to sins of commission rather than omission.

Vaughan v. Eastern. Edison Co., 719 N.E.2d 520, 525 (Mass. App 1999) (citations and quotation marks omitted).  The mere “creation of a policy” is “not an undertaking to render services.”  Thorson v. Mandell, 525 N.E.2d 375, 378 (Mass. 1988). We’re concentrating on Massachusetts law here, because that is what Pietrantoni purported to apply, but these elements of negligent undertaking liability are found in case-law throughout the country.

Pietrantoni is completely silent about how the claimed risk from the PCAs allegedly not responding to plaintiff’s inquiries was increased by their non-response – compared to no PCA services existing at all. Since the allegations are that the defendant’s PCAs simply “did not instruct her to seek medical care” in response to plaintiff’s notifying them of her symptoms, 2022 WL 16857262, at *17, it’s hard to see how there could be any increased risk, given this nonfeasance situation.  Conspicuously absent in Pietrantoni is any allegation that the PCAs said or did anything that was affirmatively wrong.  The facts of Pietrantoni are thus in no way comparable to the “detailed list of warnings” that the defendant affirmatively provided to the plaintiff in Cottam v. CVS Pharmacy, 764 N.E.2d 814, 823 (Mass. 2002).

Similarly, Pietrantoni nowhere discusses facts suggestive of reliance – only that the CPRs failed to tell her to do anything.  Nowhere did any PCA affirmatively tell plaintiff that her symptoms were nothing to worry about, thereby causing the plaintiff not to seek timely medical care.  See Restatement §323, comment c (reliance can occur where a person “has been induced to forego other opportunities of obtaining assistance”).  Conceivably, such facts could exist, but not a trace of them is apparent in Pietrantoni’s discussion of plaintiff’s negligent undertaking claim.

The problem with Pietrantoni is that the decision stopped its analysis of the plaintiff’s negligent undertaking claim after determining that the complaint sufficiently alleged an undertaking and negligence.  That omits the essential elements of increased risk/reliance. Under Massachusetts law – and in similar cases just about anywhere in the country – undertaking-related allegations are necessary, but not sufficient.  A plaintiff in such a case must also allege the increased risk or reliance elements of Restatement §323.