A case from Douglas County, Nebraska, caught our eye this week for a couple of reasons. It’s a great Daubert order in an Accutane case in Nebraska state court. In addition to that, this blogger’s mother grew up on a farm in Douglas County, Nebraska. It was a lovely 80-acre parcel terraced into a gentle slope leading down to the Platte River. The Platte River is a shallow meandering river—a mile wide at the mouth and six inches deep, as some Nebraskans like to say—and it flows from west to east, eventually emptying into the Missouri River, and then on to the great Mississippi. It forms the western boundary of Douglas County.
The Platte River is no use as a commercial waterway, but because of the gradual slope of the Platte River Valley, it has been a highway into the Rocky Mountains for hundreds of years. Traders established trails through the Valley, followed by wagon trains carrying settlors and ultimately surveyors for the Trans-Continental Railroad. When the Trans-Continental Railroad was built, the government’s policy toward public lands was one of disposition. The government therefore divided parcels along the railroad’s route into 160-acre tracts and gave every other parcel to the railroad companies, with the government keeping the rest for sale to other private landowners. This checkerboard land ownership pattern persists to this day. We have not done the research, but we would wager a bushel of corn that some grantee around the turn of the twentieth century split his 160-acre grant in half and sold it to our great grandfather—resulting in our lovely 80-acre farm in Douglas County.
The Douglas County judge who decided Freeman v. Hoffman La Roche, Inc., No. CI 10-9312802, 2017 WL 385440 (Dist. Ct. Neb. Jan. 23, 2017), may or may not live within view of the Platte River, but she produced an extraordinarily exacting Daubert order that came to the correct result—the exclusion of causation opinion because the expert had not applied a reliable methodology. The plaintiff alleged that her Accutane use resulted in Crohn’s disease, which the defendants contested.
The battle came down to experts, and it is clear that this case is not the first rodeo for these experts or the lawyers. The plaintiff’s causation expert was Dr. David Sachar, who has been a plaintiffs’ expert for 15 years. He offered the opinion that Accutane caused the plaintiff’s Crohn’s disease, but he did not follow any accepted scientific method. Instead, he purported to rely on “lines of evidence” to draw his conclusions.
What are “lines of evidence”? Well, it’s not all that clear to us, but the expert identified nine categories of information: (1) Animal studies; (2) class effect; (3) biological plausibility; (4) dose relationship; (5) clinical studies; (6) adverse event and challenge/de-challenge/re-challenge reports; (7) the defendants’ internal documents; (8) published medical literature; and (9) epidemiological studies. Id. at *8. This list looks good on its face, but it does not disclose a scientific method, let alone application of a scientific method to draw a valid conclusion. Put another way, this expert was probably able to produce a nice long report—assuming that expert reports are required and/or permitted under Nebraska procedure. But a long-winded report is not necessarily good science.
Fortunately, this trial judge was not taken in. After reviewing the parties’ submissions and holding a two-day hearing, the court catalogued in chronological order each piece of evidence that the parties offered—every article, every study, every case report, every adverse event report, etc. Id. at **1-7. The order then reviewed the expert’s hearing testimony and went through each “line of evidence” that he offered.
There are two things that stand out. First, the court noted that the expert’s opinions “morphed and changed” over the course of his direct examination. He first offered causation opinions with regard to inflammatory bowel disease—which this plaintiff did not have. He then shifted his opinions to inflammatory bowel disease “of the colon,” and then to Crohn’s disease “of the colon.” Id at *7. He apparently was trying to shoehorn previously formed opinions on IBD into a Crohn’s disease case, and the court was not amused that he was attempting “to tailor an opinion to fit the facts.” Id. at *18.
Second, the court held that under Nebraska’s version of Daubert—Schafersman v. Agland Coop, 631 N.W.2d 862 (Neb. 2001)—an expert has to identify both a valid methodology and the reliable application of that methodology. As the court explained,
When a step in an otherwise valid methodology is performed incorrectly, we fail to see how the expert’s results can be any more reliable than if the methodology itself had been wholly invalid. Accordingly, we hold that it is not enough for the trial court to determine that an expert’s methodology is valid in the abstract. The trial court must also determine if the witness has applied the methodology in a reliable manner.
Id. at *17 (emphasis added).
So both the method and the application matter, and that is where Dr. Sachar’s opinions unraveled. It was not enough for Dr. Sachar to cite to “lines of evidence” (the quotation marks are the court’s, not ours). Instead, “he must actually employ the accepted scientific methodology as it is practiced by others in their field.” Id. at *19 (emphasis in original). In the end, Dr. Sachar’s failure to do that resulted in opinion that “was a moving target throughout the testimony evidencing an unacceptable level of subjectivity.” Id. at 20. For example, he placed the greatest emphasis on 12 reports of challenge/de-challenge/re-challenge, stating that this was “as close to absolute proof [of causation] as you can get.” Id. at *6. But he is wrong. Twelve reports of positive re-challenge over a seventeen-year time span are nothing more than 12 anecdotal case reports, each with its own potentially confounding factors.
Another example was Dr. Sachar’s dismissal of epidemiological studies that contradicted his causation opinion. He called some of them a “waste of time” because they did not distinguish inflammatory bowel disease from Crohn’s or did not distinguish between Crohn’s disease “of the colon” versus Crohn’s disease in other anatomical locations. Id. at **10-11. But he admitted there were no published studies to support these distinctions, and other experts testified that Dr. Sachar’s distinctions were not recognized by the relevant scientific community. Id. at *12. Most tellingly, Dr. Sachar himself ignored these distinctions in addressing other “lines of evidence” when it suited his purpose. When relying so heavily on case reports of positive re-challenge, it made no difference to Dr. Sachar where the disease occurred or what diagnosis on re-challenge the physician actually made. Id. at *20. That is talking out of both sides of your mouth, and it is not good. It is an unreliable scientific methodology. Id. at *21.
The court closed with an eloquent acknowledgment of its responsibility as a gatekeeper and a direct but fair assessment of Dr. Sachar. We will let it speak for itself:
This Court believes it has applied the appropriate degree of scrutiny to Dr. Sachar’s testimony and it is clear to the Court that Dr. Sachar has indeed, contorted the weight-of-the-evidence methodology to arrive at a predetermined causation opinion. . . . By choosing to disregard the epidemiological studies on an unrecognized and unsupported basis . . . and instead relying on anecdotal case reports to establish causation, Dr. Sachar’s opinions are exposed. . . .
. . . . Dr. Sachar has maintained arguably financially lucrative opinion and does not reassess validity of those conclusions as new evidence has developed. Rather, as it appears from the evidence before this Court, he defends the conclusions by shifting the underlying premise to justify his current extrapolated conclusion to fit the facts of the case.
Id. at *22. That last part is good. Testifying as an expert for 15 years does not excuse you from meeting Daubert (or Nebraska’s Schafersman), which requires reliable application of a valid methodology. Dr. Sachar failed. That is the opinion of a trial judge in Douglas County, Nebraska. As for the plaintiff, we’d say she is up a shallow river without a paddle.