All of us – defense lawyers, plaintiff lawyers, and judges – tend to assume that the federal Daubert standard for admissibility of expert testimony is more rigorous than competing standards, particularly the Frye standard, which lingers in a minority of jurisdictions (and not even where it originated). In simple terms, Frye merely asks whether the expert opinions find general acceptance in the relevant expert community, whereas Daubert digs into the reliability of the particular opinions. Put another way, Frye makes judges count experts, whereas Daubert makes them become experts. Maybe that is why there are so many judges that hate Daubert and apply it in name only. When application of the Daubert standard results in exclusion of an expert opinion, it is usually the reliability component, not, say, qualifications, that does the excluding. Daubert's reliability component, in turn, contains several components. Some are highly technical, such as rate of error. Others are a little easier to understand, such as whether the expert opinions are litigation-driven, whether peer review literature supports the opinions, and – ta da! – whether the opinions find general acceptance in the field. That is, Daubert incorporates Frye to a certain extent. But whereas general acceptance is the whole ballgame in Frye, general acceptance is only one among several factors, and is not by itself dispositive. Consequently, one can dream up a scenario where an expert opinion might get knocked out by the Frye standard but would make it to the jury under Daubert. Think of an expert opinion that lacks general acceptance but otherwise can lay claim to other indicia of reliability. You might not find it terribly easy to conjure up such an expert opinion. After all, how has a reliable opinion not achieved general acceptance? Is it just too new? Would you be surprised to learn that the Daubert standard was initially created by courts to liberalize Frye? Be that as it may, the point drilled home by today's case, In re 3M Bair Hugger Litig., 2018 WL 894021 (Minn. Dist. Ct. Jan. 8, 2018), is that, every once in a while, the old Frye standard really cooks.
It appears from the introduction to the state court's opinion that a hearing on expert admissibility was held jointly before the state and federal courts in the Bair Hugger litigation. Such state-federal coordination is a welcome dose of efficiency in aggregated litigation. The plaintiffs and defendants moved to exclude each other's expert opinions, and the defendants moved for summary judgment with respect to general causation. The medical device in question was the Bair Hugger, which is used to maintain a patient's normal body temperature during surgery. The court pointedly tells us that "[m]ore than thirty years ago, it became generally accepted within the relevant scientific community that maintaining a patient's normal body temperature ("normothermia") during surgery led to decreased infection rates, a shorter period of post-operative recovery, and improved healing. This theory remains generally accepted, and various manufacturers compete to market their warming devices." Nice job foreshadowing the "general acceptance" issue. The issue in the litigation was whether the Bair Hugger's forced-air system of temperature regulation increased the chances of infection. That was the opinion proffered by the plaintiffs' three medical experts, and the issue was whether such opinions were general accepted. And now we will do a little foreshadowing ourselves: they weren't. Hug the Bair Hugger litigation goodbye.
But first you will want a bit of background. That background is a bit tawdry, and it is hard to think such background did not make it a little bit easier for the court to drop both the plaintiffs' expert opinions and complaints into the trash bin. The Bair Hugger had been invented by a fellow named Augustine. The Bair Hugger became the leading warming device in the world. Then came bad news. That inventor was notified by the United States Department of Justice that he was under investigation for Medicare fraud. Augustine resigned from the company. He later pled guilty, was fined $2 million, and was prohibited from participating in federal health-care programs for five years. The Bair Hugger device continued to be successful.
Augustine later invented a competing normothermia device, this time employing electric conduction rather than forced air. He called this new device "the HotDog." As if the reference to a delicious meat snack was not enough to win over customers, Augustine then did his best to attack his old device. In 2008, he began to impugn the safety of the Bair Hugger overseas. He issued a press release criticizing forced-air warming systems such as the Bair Hugger. Augustine claimed that such devices increased the risk of surgical infections. The United Kingdom National Institute for Health and Clinical Excellence rejected this claim, concluding that forced-air warming devices were not associated with an increased risk of infection.
Then things got even nastier. Augustine hired a law firm to promote the use of HotDog patient warming, and he agreed to work with the law firm as a "non-testifying expert." That law firm eventually began to represent individuals in lawsuits to be brought against the Bair Hugger. But meanwhile, the efforts to besmirch the Bair Hugger's safety were as unsuccessful in the United States as in the United Kingdom. The FDA investigated the allegation that the Bair Hugger increased the risk of bacterial contamination. It did not agree with the allegation. And now we get a wonderful little observation from the Minnesota court that captures so much about what is wrong with mass tort drug/device litigation: "The FDA exercises a more stringent approach to product safety than state and federal courts.... The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standards used to assess tort liability." Just so. And yet we spend the major portion of the day defending claims against drugs and devices that the FDA chooses to leave on the market. We think of the Jeremiad: "And still we are not saved." (We have a post about the FDA enforcement standards being less than the common law tort "more likely than not" standard. Where do we have it? Here.)
Back to our story. The bad turns ugly. In 2012, the inventor-turned-competitor-turned-adverse-expert tried "to coerce" a defendant into purchasing his HotDog system by warning that the defendant "would suffer a significant loss of market share and 'a lot of negative marketing rhetoric'" about the Bair Hugger causing infection if the sale did not occur. It's as if the inventor was trying to make the defendant an offer it could not refuse. But guess what? The defendant refused.
Then Augustine began to market the HotDog as reducing the rate of surgical infections when compared to forced-air systems. In response, the FDA sent a warning letter to Augustine in 2012, stating that his claim was without clinical support and made without FDA approval. Meanwhile, the Hotdog in-house counsel proposed to prepare a "detailed guide" to sue the Bair Hugger. Even so, Hotdog again proposed a marriage with the Bair Hugger. Again, the proposal was rejected. Again, the FDA was forced to respond to the inventor's attempts to impugn the safety of the Bair Hugger, by issuing a letter endorsing the continuing use of forced-air warming devices and the beneficial effect of such devices on patient safety.
We remember once hearing a jury consultant say that every product liability lawsuit is a romance novel. The story goes like this: you seduced me, you harmed me, and now you have abandoned me. Well, this normothermia saga is the weirdest kind of romance novel. It as if the Hotdog inventor was stalking the Bair Hugger, mixing entreaties of "marry me" with the most hateful invectives and assaults. Fabio is nowhere in sight. Even the Lifetime Network would take a pass on this improbable narrative.
Naturally, this narrative culminates in mass litigation. Augustine and his law firm saw 60 cases get filed in Minnesota state court and thousands of cases in federal court. Those cases rested on a three-legged stool of three iffy general-causation medical expert opinions. Notably, "[n]one of these experts had studied the efficacy of forced-air warming devices prior to being retained by Plaintiffs. They have not published any peer-reviewed articles relevant to the claims made in this litigation. They do not claim that their general-causation opinions are generally accepted within the relevant scientific community." The experts were named Samet, Stonnington, and Jarvis, and odds are that you have encountered at least one of them in the long inglorious history of plaintiff experting. You will hardly be surprised to hear that the defendants argued that the opinions were not generally accepted within the relevant scientific community and, therefore, were inadmissible under Minnesota law. There was no mention of Daubert, since Minnesota is not a Daubert state. Don't worry; Daubert was not needed.
The plaintiffs' only argument to save the expert opinions was that the general-acceptance requirement does not apply to an expert's opinion. Rather, the standard applies only to the "methodology" an expert uses to arrive at his or her opinion. We have to give the plaintiffs credit. They placed their finger on the key issue in many Frye jurisdictions. What has to be generally accepted, the bottom-line, ultimate opinion, or the methodological bits utilized to arrive at that opinion? Mind you, it's not as if separating one from the other is perfectly obvious. The Minnesota court consulted both precedents from its own state as well as a Florida case desperately seized upon by the plaintiffs, and then announced its own bottom-line, ultimate opinion: the opinion itself, not just the methodology, must find general acceptance. The general-acceptance prong under Minnesota law applies to "opinion or evidence" that "involves novel scientific theory," and requires that the "underlying scientific evidence" be generally accepted. The opinion that forced-air warming devices increase the rate of surgical site infections "is undisputedly novel and not generally accepted. Plaintiffs' attempt to narrowly apply the rule must be rejected." The court reasoned that if the plaintiffs' "interpretation were applied to its extreme, a witness would be able to opine that the earth is flat, or the center of the universe, if the person's methodology for arriving at those opinions was generally accepted." True, and one can be sure that such extreme application will show up before the year is out. Interestingly, the Minnesota court quoted an earlier Minnesota precedent to the effect that the application of the Frye [in Minnesota it is called Frye–Mack] "avoids the problem that many commentators see as inherent in Daubert, namely, that such an approach "takes from scientists and confers upon judges *** the authority to determine what is scientific." But when most other courts praise the superiority of Frye, it is whilst they are in the process of waving by junk science. What is so important and powerful about this decision is that it shows how Frye can be applied to bar junk science at the courthouse steps. You should definitely have this opinion in your pocket the next time you visit Minnesota. You should probably use it in any Frye jurisdiction. You can probably exploit it here in the Commonwealth of Pennsylvania, where we have heard references to "Fraubert." Heck, you can probably be clever enough to use this opinion in the right circumstances in a Daubert jurisdiction.
By the way, there was a second argument supporting summary judgment for the defendants. (When you win in the trial court, there is nothing better than provision of alternative grounds by the court. It makes the appellate adventure so much more pleasant.) Even if the general-causation opinions of the plaintiffs' experts were admissible, the plaintiffs "have failed to establish that it is generally accepted that the risk of infection associated with forced-air warming devices is greater than the risk of infection associated with hypothermia during surgery or when compared to other warming devices." It is a double whammy. There was no generally accepted scientific evidence that the risk of infection associated with forced air normothermia devices was greater than that associated with patients who are not warmed during surgery, and there is no scientific evidence that warming devices other than forced air warming devices have a lesser rate of infection. There is no there there.
After an application of Frye so robust as to call to mind Minnesota Governor Ventura, the court ends by dispensing a couple of other goodies to the defense bar. First, the court praises the general acceptance test because it "values the primacy of science over litigation-driven opinion by allowing the medical and other scientific communities to abide by those generally accepted practices that promote patient safety, and marginalizes the effect of other opinions and efforts that might be unduly influenced by litigation and/or competition." Or, as we've said more than once before, law must lag science, not try to lead it. (Thank you, Judge Posner.) Second, the court observes that "the history leading to this litigation also demonstrates the importance of the general-acceptance standard when the threat or fear of litigation is used as a competitive tool." Amen. But while the abuse of science is especially obvious in this case, it exists in some significant form in most drug or device litigations, whether or not a vengeful inventor or romantic pursuer lurks just offstage.
This article is presented for informational purposes only and is not intended to constitute legal advice.
