The U.S. Court of Appeals for the Third Circuit has held that plaintiffs cannot state a claim for medical monitoring based upon allegations that the implantation of a purportedly defective medical device created an increased risk of future harm. M.G. v. A.I. DuPont Hosp. for Children, 2010 WL 3310720 (3d Cir. Aug. 24, 2010) (unpublished).
Plaintiff was born with several heart defects that reduced her heart’s ability to adequately pump blood to her lungs. In an attempt to treat plaintiff’s condition without performing open heart surgery, doctors used a relatively new procedure that included the implantation of a stent that had not been approved by the FDA. Plaintiff suffered complications following the procedure and sued the stent manufacturer as well as several doctors and hospitals, asserting a claim for (among other things) medical monitoring. Plaintiff alleged that the stent was defective and created “a significantly increased risk” of side effects, making “periodic diagnostic and medical examinations reasonable and necessary.” The district court denied the defendants’ motion for summary judgment on plaintiff’s medical monitoring claim but certified several questions concerning that claim for interlocutory review.
The Third Circuit reversed the district court’s denial of summary judgment on plaintiff’s medical monitoring claim. The court concluded that the district judge had improperly “extend[ed] Delaware law beyond the bounds of the recognized medical monitoring claim in which a plaintiff alleges long-term exposure to a proven toxic substance with known tendencies to produce serious future medical injuries.”
The court explained that the stent implanted in plaintiff was not a “toxic or hazardous substance, as such. While unapproved devices are termed ‘adulterated,’ they are not necessarily harmful, and certainly not toxic.” Moreover, the court noted that the “risk here is not a risk of ‘contracting a serious latent disease.’ Rather, it is a risk of the need for further care. Further examinations are not to ‘monitor’ the risk of disease, but to perform routine oversight.” Accordingly, even assuming that “the Delaware Supreme Court would recognize a ‘standard’ medical monitoring claim,” the Third Circuit held that plaintiff failed “to establish the elements necessary to make out” such a claim.
The Third Circuit’s opinion is of obvious import to medical device manufacturers. While courts across the country have grappled with the question of whether to adopt a medical monitoring claim for asymptomatic plaintiffs, those claims have typically been brought in toxic tort suits. Relatively few courts have faced attempts to extend medical monitoring claims to the context of implantable medical devices. The Third Circuit’s conclusion that the implantation of allegedly defective medical devices cannot support a claim for medical monitoring therefore may be persuasive in future litigation.
For more information about medical monitoring claims, please see this article written by Mayer Brown partners Herbert L. Zarov, Craig A. Woods, and Stephen J. Kane, A Medical Monitoring Claim for Asymptomatic Plaintiffs: Should Illinois Take the Plunge?, 12 De Paul J. Health Care L. 1 (2009).