Medical Monitoring

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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.

 

 

 

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing theory of recovery.  Just last month, we noted that it looked like the issue had been largely resolved against allowing such claims or relief.  Sometimes, the issue is whether the plaintiff sufficiently pleads the elements of a medical monitoring claim in a jurisdiction that recognizes it.   Today’s case involves a different consideration of medical monitoring, looking at whether the requirements of Fed. R. Civ. 23 are met and a medical monitoring class can be certified.  There is quite a bit to Barraza v. C.R. Bard Inc., No. CV16-01374-PHX-DGC, 2017 WL 3976720 (D. Ariz. Sept. 11, 2017), and we are only going to focus we find most interesting.

Barraza comes from an IVC Filter MDL, which has been the source of some other decisions that drew our interest, and ultimately focused on the question of whether class certification was appropriate for eleven separate classes, each for the residents of a state that has recognized medical monitoring and had a resident proposed class representative.  Each class sought medical monitoring for people with one of seven of the defendant’s IVC filter devices in-place (after being implanted at any time) who had not brought a case alleging personal injury.  In other words, these were to be classes of uninjured plaintiffs with on-going use of the allegedly defective devices.  (Note that the proposed class definition does not expressly exclude all patients claiming current complications, but the court addresses the case as though it presents a “no injury” class, so we will too.)  Keep in mind that a common reason for rejecting medical monitoring has been that the tort system is predicating on an actual injury, giving rise to accrual of claims, damages that can be determined by somewhat predictable rules, a duty to mitigate, etc., and people who have not have an actual injury do not fit well within the existing tort system.  Someone with an actual injury, however, may be entitled to compensation for on-going medical care to minimize the progression or sequelae of the injury.  With that in mind, we turn to the evaluation of whether individual considerations or common issues predominate in trying to decide the elements of medical monitoring—as identified by the plaintiffs based on an amalgam of the law of the eleven states.

We will focus on the elements that mattered to the outcome.  While plaintiffs argued that negligent design and failure to warn could be decided on common evidence, the court disagreed.  The seven devices were designed and launched over a more than ten year period and exhibited different design features, manufacturing specifications, and testing.  Similarly, the labeling for the devices differed depending on the date and product, but seemed to address the risks that plaintiffs claim required monitoring.  “Trial of a single class representative’s claim would not suffice because the representative would have received a different filter with different warnings than many members of the class.”  Similarly, the application of affirmative defenses like assumption of the risk and contributory negligence would also turn on individual evidence about what the plaintiff and her doctor knew and did.  The court noted how some of the named plaintiffs—putative class representatives—had ignored recommendations for medical follow up and removal of the device they claim subjects them to an increased risk of harm requiring monitoring.  Thus, individual considerations in evaluating liability predominated and “the classes cannot be certified simply because Plaintiffs allegedly face a common risk and need medical monitoring.”

The related issues of whether the proposed monitoring was necessary and different from the treatment the plaintiffs would otherwise receive also turned on individual considerations.

Here, the amount of monitoring a class member would require in a normal course of her treatment and illness, without the monitoring sought in this case, is an individualized inquiry into the medical needs and ongoing course of treatment for each class member.

For instance, some named plaintiffs were already undergoing monitoring of their own doctor’s devising with different levels of compliance.

Even what law would apply to classes defined by the state of residency involved individual considerations as the state where each plaintiff’s implant surgery occurred, the state where the injury occurred, and the state where the defendant designed the products and drafted labeling could affect the law that would apply.

Put it all together and plaintiff did not come particularly close to satisfying the predominance requirement and class certification under Fed. R. Civ. P. 23(a).  (The plaintiffs also tried for certification of a 23(b)(2) class, but that was pretty much a non-starter as the relief sought—paying for monitoring—is not injunctive.)  Some of the result here is likely due to the plaintiffs’ insistence on broad classes and the selection of putative class representatives with warts, but Barraza also illustrates how class treatment of medical monitoring claims should be a long shot even when state law allows monitoring for uninjured people.

If not yet dead, the medical monitoring claim itself is hooked up to monitors and the prognosis is not good. It’s dying from a self-inflicted injury, which paradoxically is its lack of injury. Class action plaintiffs’ lawyers, the lawyers who have largely filed these claims, despise physical injuries. Physical injuries come with differences, and differences defeat class certification. On the other hand, they love financial damages, like those needed to implement a medical monitoring program. Financial damages come with sameness, and sameness increases the chances of class certification. This is the conundrum for medical-monitoring class action plaintiffs’ lawyers. They have struggled mightily to allege the financial damages that they so want while trying not to allege the physical injury that will kill their chances of certifying a class.

Cure v. Intuitive Surgical Inc., 2017 WL 3381848 (11th Cir. 2017), illustrates how this struggle is killing medical monitoring claims. In Cure, the plaintiffs claimed that, during heart surgery, instruments manufactured by the defendants shed small metallic particles that were later found in plaintiffs’ brains. Plaintiffs’ lawyers brought a medical monitoring claim, asking the court to set aside funds for monitoring plaintiffs, and those similarly situated, so that doctors could identify anything bad that might happen in the future.

But that’s where things go wrong. Plaintiffs could not allege that anything had actually gone bad. Not yet. So they hoped that the presence of small metal particles in their bodies would qualify. It doesn’t. The mere “presence of metal shavings in the plaintiffs’ brains does not, under Georgia law [applicable here], constitute a legally recognizable injury in itself.” Id. at *2. The metal particles had to have “caused or would eventually cause actual disease, pain, or impairment of some kind to support a finding that they suffered an injury.” Id. (quoting Boyd v. Orkin Exterminating Co., 381 S.E.2d 295 (Ga. Ct. App. 1989) (applying Georgia law), overruled on other grounds by Hanna v. McWilliams, 446 S.E.2d 741 (Ga. Ct. App. 1994)).

But the plaintiffs’ lawyers didn’t want to allege anything of the sort. Once they allege a disease, pain or impairment, they have entered the world of physical injury, which brings with it issues of causation, alternative causes, risk factors, predisposition and so many other things that wreck sameness and defeat class certification.

And so plaintiffs struggled mightily to avoid these class-killing problems by piecing together purported injuries that weren’t really injuries. They claimed that they “suffered and will continue to suffer physical, neurological, and mental effects.” Id. But those “vague, conclusory statements” weren’t nearly enough to satisfy the TwIqbal pleading standard. Id. They alleged that they would suffer future medical costs and lost wages. But, again, they were unable to tether these allegations to any explicit symptoms or conditions or how they would interfere with the plaintiffs’ work. Id.

In effect, plaintiffs’ claims had achieved sameness. They all had the same lack of injury. And, for that very reason, the district court dismissed plaintiffs’ medical monitoring claims, as had so many courts before it.  And, with its decision in Cure, the Eleventh Circuit upheld that dismissal. Id. at *3.