We thought we were on a winning streak on medical monitoring. In August, we blogged about plaintiff lawyers stumbling in their efforts to walk the not-quite-yet-injury line. https://www.druganddevicelawblog.com/2017/08/monitoring-the-death-of-medical-monitoring.html In September, we blogged about a denial of a medical monitoring class action because the issues were more specific than common. https://www.druganddevicelawblog.com/2017/09/medical-monitoring-class-certification-fails.html. But with the falling leaves come falling defense fortunes in the area of medical monitoring, as Judge Jones (a smart and careful judge, which does not mean we always have to agree with him) in the Middle District of Pennsylvania refused to dismiss a rather frail medical monitoring case. The case is Baker v. Deutschland GMBH et al., 2016 U.S. Dist. LEXIS 189429 (M.D. Pa. Oct. 11, 2016). The court denied a motion to dismiss a medical monitoring/declaratory judgment case involving allegations that a medical device, a heater-cooler system used to regulate blood temperature during open heart surgeries, exposed surgical patients to potentially fatal bacterial infections. The plaintiffs styled the case as a putative class action for medical monitoring that also sought a declaratory judgment of defect (which, to our jaundiced, baggy defense-hack eyes looks to be both an effort to create settlement leverage and a dodge around the issue of class certification) despite the fact that medical monitoring claims in Pennsylvania sound in negligence.

The hospitals involved in the surgeries had announced to the public that over 3500 patients had potentially been exposed to the bacteria during their heart surgeries. The bacteria in question occur naturally in the environment and rarely cause illness, but they pose “a unique health risk to those with compromised immune systems, and in particular those who have undergone invasive surgical procedures.” It can take anywhere between two weeks and four years for an infection to manifest itself in an exposed patient. Even when manifested, the symptoms are non-specific and may present in the form of “fever, pain, redness, heat or pus around a surgical incision, night sweats, joint pain, muscle pain and fatigue.” If diagnosed early, an infection from these bacteria may be successfully treated with antibiotics. But late “diagnoses pose a significant risk of death for those with weakened immune systems.” The recommended monitoring period after exposure to the bacteria is at least four years. The plaintiffs sought class certification for those who underwent open heart surgeries at certain hospitals during the respective time periods and who are currently asymptomatic for the bacterial infection. In response to the risk of exposure, the hospitals created on-site, free clinics for patients to “obtain screening for and medical treatment associated with diagnosed infections.” Later, the FDA issued a Class 2 recall of the blood heater-cooler system, citing to the potential for colonization of organisms when “proper disinfection and maintenance is not performed per instructions for use.”

The defendants moved to dismiss the medical monitoring claim. Just to review, here are Pennsylvania’s elements of a medical monitoring claim: (1) exposure greater than normal background levels; (2) to a proven hazardous substance; (3) caused by defendants’ negligence; (4) as a proximate result of the exposure, plaintiffs have a significantly increased risk of contracting a serous latent disease; (5) a monitoring program procedure exists that makes the early detection of the disease possible; (6) the prescribed monitoring regime is different from that normally recommended in the absence of exposure; (7) the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles. The defendant argued that (1) the plaintiffs could not allege a plausible claim that they were exposed to “more than the ‘mere possibility’ of exposure beyond what they would normally encounter,” (2) failed to allege a “significantly increased risk of contracting serious latent disease,” and (3) failed to allege that a “monitoring program will make early detection of disease possible.”

The Baker court rejected these arguments, pointing to allegations in the complaint that the hospitals had announced the exposures during surgery, that the heater-cooler system had aerosolized the bacteria and thereby exposed the plaintiffs to a greater amount of the bacteria than would normally be the case, that prompt detection of the bacterial infection could lead to successful treatment, and that the hospitals seemed to think that monitoring was beneficial inasmuch as they offered free clinics. Maybe some or all of these allegations would turn out to be bunk, but the court held that a motion to dismiss was not the vehicle for resolving that. Further, the court held it significant that the plaintiffs had established plausibility by alleging that other patients similarly situated had contracted infections and suffered injuries – five of whom passed away. The court reasoned that requiring more from the plaintiffs at the pleading stage made little sense since “by its nature, a medical monitoring claim attracts Plaintiffs who have not yet shown symptoms of exposure.”

The defendants also moved to dismiss the declaratory judgment action on the defect issue. The defense theory was that, because strict liability does not apply to medical devices in Pennsylvania, declaration of a defect is inappropriate. We might even call it gratuitous. The defendants also argued that a declaration of defect is inconsistent with the plaintiffs’ lack of injuries, and that, in any event, such a declaratory judgment would be ill-suited for a case about negligence – i.e., a finding of defect would not conclude the entire controversy. Again, the court rejected these arguments, holding that product defect is legally relevant to product liability claims outside the realms of strict liability, including negligence based charges. The court said that a declaration of defect would “finally resolve an issue between the parties that will undoubtedly be part of this litigation and potentially future claims as well.” Sorry, but that seems like a stretch to us. (We looked for a discussion of the SCOPA Tincher case, but did not find it.) It also seems like a waste of time. Perhaps the court was on slightly less shaky ground when it ruled that absence of physical injury was not a necessary element to the plaintiffs’ claims. It all comes down to the court’s discretion whether to hear a declaratory judgment action. The court exercised its discretion to hear the claim, or at least hear more of it, while some other courts (certainly a court helmed by an author of this blog) could and would go the other way.

This litigation appears very muddled, perhaps purposely so, as the plaintiffs, claiming only monitoring – meaning the plaintiffs were not yet injured — tried to bolster their claims by repeatedly pointing to others who actually did suffer physical injury. The Baker court found enough to get by Rule 12, but it is hard to believe there is enough here to establish a right to monitoring. The real issue in this case will be whether, after the passage of time, there remains any elevated risk of infection. We will be, ahem, monitoring this litigation for further developments.