We say it often: tragic facts lead to bad law. And the case we ranked #4 on our list of worst drug/device decisions of 2009 was definitely a case of tragic facts (and, as you can guess, we didn’t like the law too much). In that case, an infant who was born with Down Syndrome and a combination of heart defects went to a children’s hospital in Delaware, where the infant underwent a procedure that included the implantation of a stent (this stent had not been approved by the FDA). Unfortunately, the infant developed two rare and life-threatening conditions: protein losing enteropathy (PLE) and plastic bronchitis (PB). The infant’s guardians sued the hospital, the doctors, and the device manufacturer on a host of common-law negligence, strict liability, fraud, and warranty claims, and threw in a “medical monitoring” claim for good measure. The District Court judge in ED Pa. allowed the Delaware-law medical monitoring claim to proceed against the defendants – even though the Delaware Supreme Court had never ruled on the issue. In fact, the District Court allowed that medical monitoring claim to proceed at the same time it dismissed all those other common law causes of action. In other words, medical monitoring “in the air.” Totally novel (you can read more about the case here and here)….and so the case landed at #4.

Now that you know the back story, here’s the latest chapter. A couple days ago, the 3rd Circuit affirmed in part and reversed in part the district court. See M.G. v. A.I. duPont Hospital For Children, 2010 WL 3310720 (3d Cir. Aug. 24, 2010). Affirmed in part and reversed in part sounds like splitting the difference, but in this case, it means a total defense win. The 3rd Circuit affirmed the District Court’s grant of summary judgment as to all the standard common law claims, on the unsurprising ground that the plaintiffs had to prove, by expert testimony, a causal link between the defendants’ conduct and the injuries. Id. at *4-5. The plaintiffs’ expert failed to testify that the harm would not have occurred “but for” the alleged deviation in the standard of care. Id. at *5. In fact, the expert conceded that PLE and PB can develop even absent negligence, and that he did not know whether the stent or the procedure caused the injuries. Id.

But that’s not the part that really interests us. We are locked in on the second part of the opinion – the 3rd Circuit’s reversal of the decision to allow the medical monitoring claim to proceed. And in the interest of full disclosure, we should tell you that Bexis not only wrote an amicus brief on behalf of the Product Liability Advisory Council in this appeal, but came up with a winning argument: The district court overstepped its bounds in “predicting” a novel expansion of Delaware law. Id. at *5-6. In fact, it’s something that we’ve written about in this blog. So yeah, we’re pretty happy to see the 3rd Circuit agree with us. Here’s the problem, as we, and the 3rd Circuit, see it. We have no guidance from the Delaware Supreme Court about whether medical monitoring is a stand-alone tort, or whether it is instead a remedy (in other words, is it a claim or is it a measure of damages). Id. at *5. In the absence of guidance, the District Court should have done the safe thing and dismiss the claim. It’s called federalism. Instead, the 3rd Circuit agreed that “the District Court erred in extending 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.” Id. at *6. Not only did the District Court recognize a stand-alone cause of action for medical monitoring – something neither the Delaware Supreme Court nor the Delaware legislature has done – but the District Court then took the further leap of predicting that Delaware would in fact recognize a standalone medical monitoring cause of action outside the “toxic tort” context where medical monitoring claims usually arise (think chemical spills or plant explosions). Id. This was a few leaps too many for the 3rd Circuit:

[T]he District Court’s prediction that the Delaware Supreme Court would permit a claim for medical monitoring on this record requires several “leaps” from the current state of the law, generally, let alone Delaware law. Here, there is no toxic or hazardous substance, as such. While unapproved devices are termed “adulterated,” they are not necessarily harmful, and certainly not toxic. Moreover, 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.

Id. at *7. So we can erase #4 from our bottom 10 list of 2009. The medical monitoring claim here was a real stretch: (1) not a toxic tort, but a device/malpractice case; (2) not a claim for monitoring a latent disease, but a claim for medical checkups; (3) not a claim tethered to a viable negligence or strict liability theory, but a standalone claim; and last but certainly not least (4) not a claim that had EVER BEEN RECOGNIZED IN DELAWARE.

We understand the desire for compassion, to throw this poor family something. It’s tragic what happened, and it will surely be expensive to get the injured infant the care she needs. At the same time, the 3rd Circuit decision in M.G. confirms once again that tragic facts should not lead us to ignore the rule of law, or the principles of federalism.